GW PHARMACEUTICALS PLC (Form: F-1/A, Received: 03/26/2013 06:02:18)

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As filed with the United States Securities and Exchange Commission on March 26, 2013

Registration No. 333-187356

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

AMENDMENT NO. 1
TO
FORM F-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933

GW PHARMACEUTICALS PLC
(Exact name of Registrant as specified in its charter)
Not Applicable
(Translation of Registrant's name into English)



England and Wales (State or other jurisdiction of incorporation or organization)		2834 (Primary Standard Industrial Classification Code Number)		Not Applicable (I.R.S. Employer Identification Number)

Porton Down Science Park, Salisbury
Wiltshire, SP4 0JQ
United Kingdom
(44) 198 055-7000
(Address, Including Zip Code, and Telephone Number, Including Area Code, of Registrant's Principal Executive Offices)

CT Corporation System
111 Eighth Avenue, 13th Floor
New York, NY 10011
(212) 590-9330
(Name, Address, Including Zip Code, and Telephone Number, Including Area Code, of Agent For Service)

Copies to:



Edward S. Best David S. Bakst Mayer Brown LLP 1675 Broadway New York, NY 10019 Telephone: (212) 506 2500 Facsimile: (212) 262 1910		Justin D. Gover, Chief Executive Officer Adam D. George, Chief Financial Officer GW Pharmaceuticals plc Porton Down Science Park, Salisbury Wiltshire, SP4 0JQ United Kingdom Telephone: (44) 198 055-7000 Facsimile: (44) 198 055-7111		Jonathan L. Kravetz Daniel T. Kajunski Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. One Financial Center Boston, MA 02111 Telephone: (617) 542-6000 Facsimile: (617) 542-2241

Approximate date of commencement of proposed sale to the public:

As soon as practicable after the effective date of this registration statement.

If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. o

If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

CALCULATION OF REGISTRATION FEE

Title of each class of securities to be registered	Proposed maximum aggregate offering price ⁽¹⁾	Amount of registration fee ⁽²⁾




Ordinary Shares, par value £0.001 per share ⁽²⁾⁽³⁾	$50,000,000	$6,820

⁽¹⁾: Estimated solely for the purpose of determining the amount of registration fee in accordance with Rule 457(o) under the Securities Act of 1933, as amended.
⁽²⁾: Registration fee has been previously paid in connection with the initial filing of this Registration Statement.
⁽³⁾: Includes ordinary shares that the underwriters may purchase solely to cover overallotments, if any.
⁽⁴⁾: American Depositary Shares issuable on deposit of the ordinary shares registered hereby have been registered under a separate registration statement on Form F-6 (File No.: 333- ). Each American depositary share will represent ordinary shares.

The Registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Commission, acting pursuant to such Section 8(a), may determine.

Explanatory Note

GW Pharmaceuticals plc is filing this Amendment No. 1 (this "Amendment") to its Registration Statement on Form F-1 (Registration No. 333-187356) (the "Registration Statement") as an exhibit-only filing to file Exhibits 10.1 through 10.30 and 10.35 and to amend and restate the list of exhibits set forth in Item 8 of Part II of the Registration Statement. No changes have been made to Part I or Part II of the Registration Statement other than this explanatory note as well as revised versions of the cover page and Item 8 of Part II of the Registration Statement. This Amendment does not contain a copy of the preliminary prospectus included in the Registration Statement, nor is it intended to amend or delete any part of the preliminary prospectus.

Part II
INFORMATION NOT REQUIRED IN THE PROSPECTUS

Item 6. Indemnification of directors and officers

The Registrant's articles of association provide that, subject to the Companies Act 2006, every person who is or was at any time a director or other officer (excluding an auditor) of the Registrant may be indemnified out of the assets of the Registrant against all costs, charges, expenses, losses or liabilities incurred by him in performing his duties or the exercise of his powers or otherwise in relation to or in connection with his duties, powers or office.

The Registrant also maintains directors and officers insurance to insure such persons against certain liabilities.

In the underwriting agreement, the underwriters will agree to indemnify, under certain conditions, the Registrant, members of the Registrant's board of directors, members of the executive management board and persons who control the Registrant within the meaning of the Securities Act, against certain liabilities.

Item 7. Recent sales of unregistered securities

The following information is furnished with regard to all securities issued by the Registrant within the last three years that were not registered under the Securities Act. The issuance of such shares was deemed exempt from registration requirements of the Securities Act as such securities were offered and sold outside of the United States to persons who were neither citizens nor residents of the United States or such sales were exempt from registration under Section 4(a)(2) of Securities Act.

No underwriter or underwriting discount or commission was involved in any of the issuances set forth in this Item 7.

Options to Purchase Ordinary Shares

From October 1, 2009 through February 22, 2013, the Registrant issued an aggregate of 3,394,483 options to purchase ordinary shares under its equity incentive plans. Of these options:

•: options to purchase 46,350 ordinary shares have been canceled without being exercised;
•: options to purchase 190,000 ordinary shares have been exercised at a weighted average exercise price of £0.001 per share; and
•: options to purchase a total of 3,158,133 ordinary shares are currently outstanding, at a weighted average exercise price of £0.001 per share.

Item 8. Exhibits

(a): The following documents are filed as part of this Registration Statement:

		Description of Exhibit

1.1	⁽¹⁾	Form of Underwriting Agreement.
3.1	*	Memorandum & Articles of Association of GW Pharmaceuticals plc.
4.1	*	Form of specimen certificate evidencing ordinary shares.
4.2	⁽²⁾	Form of Deposit Agreement among GW Pharmaceuticals plc, Citibank, N.A., as the depositary bank and all Holders and Beneficial Owners of ADSs issued thereunder.
4.3	⁽²⁾	Form of American Depositary Receipt (included in Exhibit 4.2).
4.4	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Value Fund, L.P. dated August 2009.

II-1

		Description of Exhibit

4.5	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Value Fund, L.P. dated August 2009.
4.6	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Offshore Value Fund, L.P. dated August 2009.
4.7	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Offshore Value Fund, L.P. dated August 2009.
5.1	⁽¹⁾	Opinion of Mayer Brown International LLP as to the validity of the securities being offered under the laws of GW Pharmaceuticals plc's jurisdiction of organization.
10.1	^†	License and Distribution Agreement between Bayer AG Division Pharma and GW Pharma Ltd., dated May 20, 2003.
10.2	^†	Amendment Number 1 to the License and Distribution Agreement, dated November 4, 2003.
10.3		Amendment Number 2 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Healthcare AG Division Pharma, dated January 14, 2004.
10.4	^†	Amendment Number 3 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Healthcare AG Division Pharma, dated March 1, 2005.
10.5	^†	Amendment Number 4 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Healthcare AG Division Pharma, dated May 10, 2005.
10.6		Amendment Number 5 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Schering Pharma AG (fka Bayer AG, Bayer HealthCare, Division Pharma), dated March 10, 2010.
10.7	^†	Supply Agreement between Bayer AG and GW Pharma Ltd., dated May 20, 2003.
10.8	^†	Amendment Number 1 to the Supply Agreement between GW Pharma Ltd. and Bayer Healthcare AG, dated November 4, 2003.
10.9	^†	Amendment Number 2 to the Supply Agreement between GW Pharma Ltd. and Bayer Healthcare AG, dated May 10, 2005.
10.10	^†	Amendment Number 3 to the Supply Agreement between GW Pharma Ltd. and Bayer Schering Pharma AG (fka Bayer AG, Bayer HealthCare, Division Pharma), dated March 10, 2010.
10.11	^†	Product Commercialisation and Supply Consolidated Agreement between GW Pharma Limited and Almirall Prodesfarma, S.A., dated June 6, 2006.
10.12	^†	Amendment No. 1 to the Product Commercialisation and Supply Consolidated Agreement between GW Pharma Ltd. and Laboratorios Almirall S.A., dated March 4, 2009.
10.13	^†	Amendment to the Product Commercialisation and Supply Consolidated Agreement, dated June 6, 2006 between GW Pharma Ltd. and Almirall S.A., dated July 23, 2010.
10.14	^†	Supplementary Agreement to the Product Commercialisation and Supply Consolidated Agreement, dated June 6, 2006 between GW Pharma Ltd. and Almirall S.A., dated November 17, 2011.
10.15	^†	Amendment and Supplementary Agreement to the Product Commercialisation and Supply Consolidated Agreement, dated June 6, 2006 between GW Pharma Ltd. and Almirall S.A., dated March 13, 2012.

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		Description of Exhibit

10.16	^†	Research Collaboration and Licence Agreement between GW Pharma Ltd. and GW Pharmaceuticals plc and Otsuka Pharmaceutical Co., Ltd., dated July 9, 2007.
10.17	^†	Amendment No. 1 to Research Collaboration and Licence Agreement, dated March 14, 2008.
10.18	^†	Amendment No. 2 to Research Collaboration and Licence Agreement, dated June 29, 2010.
10.19	^†	Development and License Agreement between GW Pharma Ltd. and GW Pharmaceuticals Plc and Otsuka Pharmaceutical Co., Ltd., dated February 14, 2007.
10.20	^†	Amendment No. 1 to Development and License Agreement, dated November 1, 2008.
10.21	^†	Letter amending Development and License Agreement, dated October 21, 2010.
10.22	^†	Distribution and License Agreement, dated April 8, 2011, by and between GW Pharma Ltd. and Novartis Pharma AG.
10.23	^†	Manufacturing and Supply Agreement, dated November 9, 2011, by and between Novartis Pharma AG and GW Pharma Ltd.
10.24	^†	Production Supply Agreement, dated March 7, 2007.
10.25	^†	Lease, dated July 6, 2009.
10.26	^†	Lease, dated October 9, 2009.
10.27	^†	Lease, dated April 6, 2011.
10.28	^†	Lease, dated October 12, 2011.
10.29	^†	Lease, dated January 6, 2012.
10.30	^†	Agreement for Lease, dated April 4, 2012.
10.31	*	Occupational Underlease, dated August 11, 2010.
10.32	*	Lease, dated May 24, 2011.
10.33	*	Tenancy Agreement, dated November 19, 2012.
10.34	*	Service Agreement by and between GW Pharma Ltd., and Adam George, dated June 1, 2012.
10.35	^†	Service Agreement by and between GW Pharma Ltd., and Chris Tovey, dated July 11, 2012.
10.36	*	Service Agreement by and between GW Research Ltd. and Dr. Geoffrey Guy, dated March 14, 2013.
10.37	*	Service Agreement by and between GW Research Ltd. and Justin Gover, dated February 26, 2013.
10.38	*	Service Agreement by and between GW Research Ltd. and Dr. Stephen Wright, dated January 18, 2013.
10.39	*	Letter of Appointment by and between GW Pharmaceuticals plc and James Noble, dated February 26, 2013.
10.40	*	Letter of Appointment by and between GW Pharmaceuticals plc and Tom Lynch, dated February 26, 2013.
10.41	*	Letter of Appointment by and between GW Pharmaceuticals plc and Cabot Brown, dated February 19, 2013.

II-3

		Description of Exhibit

10.42	*	Long Term Incentive Plan.
10.43	*	GW Pharmaceuticals All Employee Share Scheme.
10.44	*	GW Pharmaceuticals Approved Share Option Scheme 2001.
10.45	*	GW Pharmaceuticals Unapproved Share Option Scheme 2001.
21.1	*	List of Subsidiaries.
23.1	*	Consent of Deloitte LLP.
23.2	⁽¹⁾	Consent of Mayer Brown International LLP (included in Exhibit 5.1).
24.1	⁽¹⁾	Powers of Attorney (included in the signature page to this Registration Statement).

*: Previously filed.
^†: Confidential treatment requested.
⁽¹⁾: To be filed in an amendment to this registration statement prior to effectiveness.
⁽²⁾: Incorporated by reference to the Registration Statement on Form F-6 (File No. 333- ), filed with the Securities and Exchange Commission with respect to ADSs representing ordinary shares.

(b): Financial Statement Schedules

All Schedules have been omitted because the information required to be presented in them is not applicable or is shown in the consolidated financial statements or related notes.

Item 9. Undertakings

(a)

The undersigned Registrant hereby undertakes to provide to the underwriters at the closing specified in the underwriting agreements, certificates in such denominations and registered in such names as required by the underwriters to permit prompt delivery to each purchaser.

(b)

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers and controlling persons of the Registrant pursuant to the foregoing provisions, or otherwise, the Registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the Registrant of expenses incurred or paid by a director, officer, or controlling person of the Registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the Registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question of whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.

(c)

The undersigned Registrant hereby undertakes that:

(1): For purposes of determining any liability under the Securities Act, the information omitted from the form of prospectus filed as part of this Registration Statement in reliance upon Rule 430A and contained in a form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this Registration Statement as of the time it was declared effective.
(2): For the purpose of determining any liability under the Securities Act, each post-effective amendment that contains a form of prospectus shall be deemed to be a new Registration Statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.

II-4

SIGNATURES

Pursuant to the requirements of the Securities Act of 1933, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-1 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Salisbury, England, on March 26, 2013.


		GW PHARMACEUTICALS PLC
		By:		/s/ ADAM GEORGE
				Name: Adam George Title: Chief Financial Officer

Pursuant to the requirements of the Securities Act of 1933, this Registration Statement has been signed by the following persons in the capacities and on the dates indicated.

Signature		Title	Date


* Justin Gover		Chief Executive Officer (Principal Executive Officer) and Director	March 26, 2013
/s/ ADAM GEORGE Adam George		Chief Financial Officer (Principal Financial and Accounting Officer) and Director	March 26, 2013
* Dr. Geoffrey Guy		Director	March 26, 2013
* Dr. Stephen Wright		Director	March 26, 2013
* Chris Tovey		Director	March 26, 2013
* James Noble		Director	March 26, 2013
* Cabot Brown		Director and Authorized U.S. Representative	March 26, 2013
* Thomas Lynch		Director	March 26, 2013
*By:	/s/ ADAM GEORGE Adam George Attorney-in-Fact

II-5

EXHIBIT INDEX

		Description of Exhibit

1.1	⁽¹⁾	Form of Underwriting Agreement.
3.1	*	Memorandum & Articles of Association of GW Pharmaceuticals plc.
4.1	*	Form of specimen certificate evidencing ordinary shares.
4.2	⁽²⁾	Form of Deposit Agreement among GW Pharmaceuticals plc, Citibank, N.A., as the depositary bank and all Holders and Beneficial Owners of ADSs issued thereunder.
4.3	⁽²⁾	Form of American Depositary Receipt (included in Exhibit 4.2).
4.4	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Value Fund, L.P. dated August 2009.
4.5	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Value Fund, L.P. dated August 2009.
4.6	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Offshore Value Fund, L.P. dated August 2009.
4.7	*	Share Warrant to subscribe for ordinary shares issued to Biomedical Offshore Value Fund, L.P. dated August 2009.
5.1	⁽¹⁾	Opinion of Mayer Brown International LLP as to the validity of the securities being offered under the laws of GW Pharmaceuticals plc's jurisdiction of organization.
10.1	^†	License and Distribution Agreement between Bayer AG Division Pharma and GW Pharma Ltd., dated May 20, 2003.
10.2	^†	Amendment Number 1 to the License and Distribution Agreement, dated November 4, 2003.
10.3		Amendment Number 2 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Healthcare AG Division Pharma, dated January 14, 2004.
10.4	^†	Amendment Number 3 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Healthcare AG Division Pharma, dated March 1, 2005.
10.5	^†	Amendment Number 4 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Healthcare AG Division Pharma, dated May 10, 2005.
10.6		Amendment Number 5 to the License and Distribution Agreement between GW Pharma Ltd. and Bayer Schering Pharma AG (fka Bayer AG, Bayer HealthCare, Division Pharma), dated March 10, 2010.
10.7	^†	Supply Agreement between Bayer AG and GW Pharma Ltd., dated May 20, 2003.
10.8	^†	Amendment Number 1 to the Supply Agreement between GW Pharma Ltd. and Bayer Healthcare AG, dated November 4, 2003.
10.9	^†	Amendment Number 2 to the Supply Agreement between GW Pharma Ltd. and Bayer Healthcare AG, dated May 10, 2005.
10.10	^†	Amendment Number 3 to the Supply Agreement between GW Pharma Ltd. and Bayer Schering Pharma AG (fka Bayer AG, Bayer HealthCare, Division Pharma), dated March 10, 2010.

II-7

		Description of Exhibit

10.11	^†	Product Commercialisation and Supply Consolidated Agreement between GW Pharma Limited and Almirall Prodesfarma, S.A., dated June 6, 2006.
10.12	^†	Amendment No. 1 to the Product Commercialisation and Supply Consolidated Agreement between GW Pharma Ltd. and Laboratorios Almirall S.A., dated March 4, 2009.
10.13	^†	Amendment to the Product Commercialisation and Supply Consolidated Agreement, dated June 6, 2006 between GW Pharma Ltd. and Almirall S.A., dated July 23, 2010.
10.14	^†	Supplementary Agreement to the Product Commercialisation and Supply Consolidated Agreement, dated June 6, 2006 between GW Pharma Ltd. and Almirall S.A., dated November 17, 2011.
10.15	^†	Amendment and Supplementary Agreement to the Product Commercialisation and Supply Consolidated Agreement, dated June 6, 2006 between GW Pharma Ltd. and Almirall S.A., dated March 13, 2012.
10.16	^†	Research Collaboration and Licence Agreement between GW Pharma Ltd. and GW Pharmaceuticals plc and Otsuka Pharmaceutical Co., Ltd., dated July 9, 2007.
10.17	^†	Amendment No. 1 to Research Collaboration and Licence Agreement, dated March 14, 2008.
10.18	^†	Amendment No. 2 to Research Collaboration and Licence Agreement, dated June 29, 2010.
10.19	^†	Development and License Agreement between GW Pharma Ltd. and GW Pharmaceuticals Plc and Otsuka Pharmaceutical Co., Ltd., dated February 14, 2007.
10.20	^†	Amendment No. 1 to Development and License Agreement, dated November 1, 2008.
10.21	^†	Letter amending Development and License Agreement, dated October 21, 2010.
10.22	^†	Distribution and License Agreement, dated April 8, 2011, by and between GW Pharma Ltd. and Novartis Pharma AG.
10.23	^†	Manufacturing and Supply Agreement, dated November 9, 2011, by and between Novartis Pharma AG and GW Pharma Ltd.
10.24	^†	Production Supply Agreement, dated March 7, 2007.
10.25	^†	Lease, dated July 6, 2009.
10.26	^†	Lease, dated October 9, 2009.
10.27	^†	Lease, dated April 6, 2011.
10.28	^†	Lease, dated October 12, 2011.
10.29	^†	Lease, dated January 6, 2012.
10.30	^†	Agreement for Lease, dated April 4, 2012.
10.31	*	Occupational Underlease, dated August 11, 2010.
10.32	*	Lease, dated May 24, 2011.
10.33	*	Tenancy Agreement, dated November 19, 2012.
10.34	*	Service Agreement by and between GW Pharma Ltd., and Adam George, dated June 1, 2012.

II-8

		Description of Exhibit

10.35	^†	Service Agreement by and between GW Pharma Ltd., and Chris Tovey, dated July 11, 2012.
10.36	*	Service Agreement by and between GW Research Ltd. and Dr. Geoffrey Guy, dated March 14, 2013.
10.37	*	Service Agreement by and between GW Research Ltd. and Justin Gover, dated February 26, 2013.
10.38	*	Service Agreement by and between GW Research Ltd. and Dr. Stephen Wright, dated January 18, 2013.
10.39	*	Letter of Appointment by and between GW Pharmaceuticals plc and James Noble, dated February 26, 2013.
10.40	*	Letter of Appointment by and between GW Pharmaceuticals plc and Tom Lynch, dated February 26, 2013.
10.41	*	Letter of Appointment by and between GW Pharmaceuticals plc and Cabot Brown, dated February 19, 2013.
10.42	*	Long Term Incentive Plan.
10.43	*	GW Pharmaceuticals All Employee Share Scheme.
10.44	*	GW Pharmaceuticals Approved Share Option Scheme 2001.
10.45	*	GW Pharmaceuticals Unapproved Share Option Scheme 2001.
21.1	*	List of Subsidiaries.
23.1	*	Consent of Deloitte LLP.
23.2	⁽¹⁾	Consent of Mayer Brown International LLP (included in Exhibit 5.1).
24.1	⁽¹⁾	Powers of Attorney (included in the signature page to this Registration Statement).

*: Previously filed.
^†: Confidential treatment requested.
⁽¹⁾: To be filed in an amendment to this registration statement prior to effectiveness.
⁽²⁾: Incorporated by reference to the Registration Statement on Form F-6 (File No. 333- ), filed with the Securities and Exchange Commission with respect to ADSs representing ordinary shares.

II-9

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Explanatory Note
Part II INFORMATION NOT REQUIRED IN THE PROSPECTUS

Item 6. Indemnification of directors and officers

Item 7. Recent sales of unregistered securities

Item 8. Exhibits

Item 9. Undertakings

Exhibit 10.1

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

BAYER AG

and

GW PHARMA LTD

LICENSE AND DISTRIBUTION AGREEMENT

CONTENTS

1. DEFINITIONS AND INTERPRETATION		3
2. GRANT OF RIGHTS TO THE PRODUCTS		7
3. TERRITORY OPTION PROCEDURE		7
4. PAYMENTS		8
5. DEVELOPMENT OBLIGATIONS		9
6. COMMERCIALISATION OBLIGATIONS		9
7. REGULATORY OBLIGATIONS		11
8. CONFIDENTIALITY AND ANNOUNCEMENTS		13
9. INTELLECTUAL PROPERTY OWNERSHIP, PATENT PROSECUTION AND LITIGATION		15
10. TRADEMARKS AND PRODUCT MARKING		16
11. STATEMENTS AND REMITTANCES		18
12. TERM AND TERMINATION		18
13. RIGHTS AND DUTIES UPON TERMINATION		20
14. WARRANTIES AND REPRESENTATIONS		20
15. INDEMNITIES AND LIMITATION; INSURANCE		21
16. FORCE MAJEURE; HARDSHIP		22
17. GOVERNING LAW AND DISPUTE RESOLUTION		22
18. WAIVER OF BREACH		23
19. SEVERABILITY		23
20. ENTIRE AGREEMENT		23
21. NOTICES		24
22. ACQUISITION OR MERGER OF BAYER PHARMACEUTICAL BUSINESS AND ASSIGNMENT		24
23. THIRD PARTY RIGHTS		25
24. COUNTERPARTS		25
APPENDIX 1 - PRODUCTS		26
APPENDIX 2 - TERRITORY		27
APPENDIX 3 - LAUNCH CONDITIONS, UPFRONTS, MILESTONE EVENTS and PAYMENTS		28
APPENDIX 4 - GW IPR		30
APPENDIX 5 - TRADE MARK		31

LICENSE AND DISTRIBUTION AGREEMENT

THIS LICENSE AND DISTRIBUTION AGREEMENT (hereinafter “Agreement”), is made as of the 20 th day of May 2003, between GW PHARMA LIMITED (“GW”) having its registered office at Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ and BAYER AG, Bayer HealthCare, Division Pharma, having its registered office at Bayerwerk, 51368 Leverkusen, Germany (“Bayer”).

WHEREAS , GW is the owner of all right, title and interest in certain patents and know-how relating to certain cannabinoid products and desires to grant a licence to the rights to sell and distribute such cannabinoid products in the Territory;

WHEREAS , Bayer and its Affiliates have experience in the market development, marketing, promotion and sale of pharmaceutical products and desire to obtain a licence to the rights to sell and distribute such cannabinoid products in the Territory and GW is willing to grant to Bayer such rights;

WHEREAS , Bayer and GW entered into a Non-Disclosure Agreement on 27 December 2002; and

WHEREAS , Bayer and GW entered into a Supply Agreement, a Loan Agreement and a Subscription Option Agreement as of the date hereof.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS :

1. DEFINITIONS AND INTERPRETATION

1.1. “Adverse Event Reporting” shall mean the procedure relating to drug safety and/or pharmacovigilance concerning Products as separately agreed upon between the Parties.

1.2. “Affiliates” shall mean any corporation or other entity which is directly or indirectly controlling, controlled by or under common control of a Party hereto for so long as such control exists. For the purposes of this definition “control” shall mean the direct or indirect ownership of at least fifty per cent (50%) of the outstanding shares or other voting rights of the subject entity having the power to vote on or direct the affairs of the entity.

1.3. “Background Rights” shall mean the Intellectual Property Rights and rights of a similar nature owned by each of the parties as at the Effective Date.

1.4. “CBD” shall mean cannabidiol.

1.5. “Contract Governance Committee” shall mean the committee with overall responsibility for the management of this Agreement comprising two (2) senior management representatives from each of Bayer and GW.

1.6. “Controlled Drugs Authority” shall mean the UK Home Office and any equivalent body responsible within the Territory in relation to the control, licensing or supervision of controlled or similarly restricted drugs.

1.7. “Country Commercialisation Committee(s)” shall mean the committee responsible in each country of the Territory for the strategic commercialisation of the Products each comprising two (2) management representatives from GW and appropriate representation from the marketing function of the relevant Bayer Affiliate. For the avoidance of doubt a management representative may serve on more than one Country Commercialisation Committee.

1.8. “EEA” shall mean the European Economic Area.

1.9. “Effective Date” shall mean the date upon which this Agreement is effective and shall be the date of this Agreement first written above.

1.10. “Foreground Rights” shall mean the Intellectual Property Rights and rights of a similar nature arising out of all inventions, discoveries and know-how which are made, conceived, reduced to practice or generated by the Parties, their respective employees, agents, or other persons acting under such Parties’ authority in the course of or as a result of this Agreement and relating to the Products.

1.11. “Good Distribution Practice” shall mean the EC Guidelines of Good Distribution Practice on Medicinal Products for Human Use (2001/83/EC) or equivalent Laws in the Territory.

1.12. “Governmental Authority” shall mean or include (according to context) a Medicinal Products Regulatory Authority, patent offices, a Treatment Endorsement Body, a Controlled Drugs Authority and any other local or national agency, authority court, tribunal, arbitrator, agency, commission, inspectorate, official or other instrumentality of a government with application within the Territory.

1.13. “GW IPR” shall mean the Intellectual Property Rights including without limitation GW Patents, GW Know-How and GW Plant Variety Rights owned by or which become owned during the Term of this Agreement by GW or its Affiliates to this Agreement which relate directly to the Products. The GW IPR currently owned by GW or its Affiliates is set out in Appendix 4 ; Appendix 4 shall be updated any time during the Term of this Agreement upon Bayer’s request from time to time to reflect GW IPR which becomes owned by GW or its Affiliates.

1.14. “GW Know-how” shall mean all present and future technical information and know-how which relates directly to the Products, which is confidential or is not in the public domain and to which is proprietary to GW and shall include without limitation, all biological, chemical, pharmacological, toxicological, clinical, assay, control and manufacturing data, ideas, concepts, drawings, methods of use or application and any other information necessary for the sale in the Territory of the Products.

1.15. “GWP” shall mean GW Pharmaceuticals PLC.

1.16. “GW Patents” shall mean all patents and patent applications relating directly to the Products owned by GW which cover the making, having made, the disposal of, or offer to dispose of, use, offer for sale or sale, including, without limitation, of a process for manufacturing the Products or a starting material or an intermediate or manufacturing equipment used in such process. Included within the definition of GW Patents are all continuations, continuations-in-part, divisions, patents of addition, utility patents, reissues, renewals, re-examination, requests for continued examination, registrations, patents of importation or patent term extensions thereof including SPCs.

1.17. “GW Plant Variety Right” shall mean a right granted to GW by the Community Plant Variety Office or a national plant variety right office under The International Convention for the Protection of New Varieties of Plants (the UPOV convention) and relating directly to the Products. Within the context of this Agreement, the term GW Plant Variety Right shall include pending applications for such rights as well as granted rights which are still in force.

1.18. “Indication” shall mean the relief of one or more primary symptoms in patients with multiple sclerosis, the relief of neuropathic pain, the relief of cancer pain and any indication granted by a Medicinal Products Regulatory Authority for Product as a result of Bayer marketing, distributing and selling Product in the Territory and/or as a result of Phase IIIb or Phase IV studies according to Clause 5.3. If not agreed otherwise between the Parties, any other indication for Product approved by a Medicinal Products Regulatory Authority as a result of a development by GW shall be expressly excluded, provided that Bayer shall have a first option on such other indication.

1.19. “Intellectual Property Rights” shall mean any rights arising or obtainable under laws relating to patents, designs, plant variety rights, know how, copyright, confidential information, trade

secrets, database rights or unfair competition whether known in any country or place under those names, but excluding trade marks.

1.20. “Launch” shall mean the first commercial sale to a Third Party within a country within the Territory by Bayer or its Affiliates of a Product.

1.21. “Launch Conditions” shall mean the country-specific terms specified in Appendix 3 , when countries are added to the Territory under the Territory Option Procedure.

1.22. “Laws” shall mean all laws, statutes, rules, regulations, ordinances and other pronouncements having the effect of law of any Governmental Authority in the Territory.

1.23. “Loan Agreement” shall mean the loan facility agreement dated the same day as this Agreement between Bayer and GWP.

1.24. “Marketing Authorisation(s)” shall mean the authorisations for the sale and marketing of the Products in the Territory granted by a Medicinal Products Regulatory Authority as may be varied from time to time.

1.25. “Medicinal Products Regulatory Authority” shall mean the competent authority in the EEA (or in any country thereof), Canada, Australia or New Zealand, or other national authority responsible for the granting and supervision of the Marketing Authorisations within the Territory.

1.26. “Net Sales” shall mean the aggregated gross amounts invoiced by Bayer in respect of gross sales of the Products in each country of the Territory under this Agreement by Bayer or its Affiliates to Third Parties at an arm’s length open market price less deductions actually allowed in relation to or specifically allocated to the Products by Bayer using generally accepted accounting standards for:

(i) ordinary and customary quantity, trade and/or cash discounts actually granted and logistics service provider fees paid and payable;

(ii) amounts repaid or credited and allowances including cash or credit, given by reason of retroactive price reductions, or billing errors or rebates actually allowed or paid;

(iii) amounts refunded or credited for the Products which were rejected, spoiled, damaged, outdated or returned;

(iv) distribution, packing, handling, freight, shipment and insurance disbursements in transporting the Products to customers;

(v) taxes and other governmental charges occurred in connection with sale of the Products; and

(vi) bad debts excluding any amounts actually recovered including VAT actually written off due to the customer going into insolvency to the extent they are attributable to the Products. In such a case, Bayer shall be entitled to deduct such an amount from gross sales less *** (***) percent of the Net Selling Price, which the Parties hereby agree represents GW’s costs of manufacture, provided always that Bayer had previously paid GW the supply price.

1.27. “Net Selling Price” shall mean Net Sales per unit of Product.

1.28. “Option” shall have the meaning given in the Subscription Option Agreement.

1.29. “Parties” shall mean Bayer and GW (and “Party” shall be construed accordingly).

1.30. “Products” shall mean the products set out in Appendix 1 to this Agreement for human use in the Indications.

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1.31. “Promotional Materials” shall mean detailing, promotional, sponsorship, educational and communication materials in hard copy or electronic form for marketing, detailing and promotion of the Products for distribution to a Third Party (including without limitation health professionals) and to Bayer’s sales force.

1.32. “Quality Agreement” shall mean the agreement to be attached to the Supply Agreement governing the technical aspects of the supply by GW of the Products.

1.33. “ Regulatory Collaboration Committee” shall mean the committee comprising two (2) representatives from each of GW and Bayer or its Affiliates in relation to obtaining Marketing Authorisations for the Products.

1.34. “Sales Targets” shall have the meaning defined in Clause 6.2.

1.35. “SmPC” shall mean the Summary of Product Characteristics forming part of a Marketing Authorisation.

1.36. “SPC” shall mean a Supplementary Protection Certificate as defined in Council Regulation (EEC) No 1768/92.

1.37. “Subscription Option Agreement” shall mean the subscription agreement dated the same day as this Agreement between Bayer and GWP.

1.38. “Supply Agreement” shall mean the agreement dated the same day as this Agreement between Bayer and GW, as amended or extended from time to time, relating to the supply of the Products.

1.39. “Supply Price” shall mean the supply price for supply of the Products as detailed in Appendix 2 of the Supply Agreement.

1.40. “Territory” shall mean the UK Territory and such other certain countries (other countries in the entire EEA, Canada, Australia and New Zealand) as shall be added to the Territory under the Territory Option Procedure and which, upon agreement by the parties in relation thereto, shall be listed in Appendix 2 to this Agreement.

1.41. “Territory Option Procedure” shall mean the procedure set out in Clause 3 below.

1.42. “Third Party” shall mean any entity other than GW, GW’s Affiliates, Bayer and Bayer’s Affiliates.

1.43. “Third Party IPR” shall mean Intellectual Property Rights owned by a Third Party.

1.44. “Trade Mark(s)” shall mean the trade marks owned by GW and used in relation to the Products listed in Appendix 5 of this Agreement and as updated from time to time.

1.45. “Treatment Endorsement Body” shall mean a Governmental Authority within the Territory with responsibility or authority for the endorsement and/or reimbursement of the Products within the Territory including without limitation the National Institute for Clinical Excellence, or any successor body.

1.46. “UK Territory” shall mean the territory of Great Britain, Northern Ireland, the Channel Islands and the Isle of Man.

1.47. In this Agreement unless it is inconsistent with the context a reference to a statutory provision includes a reference to:

(i) a statutory amendment, modification, substitution, consolidation or re-enactment (whether before or after the date of this Agreement);

(ii) statutory instruments or subordinate legislation or orders made under the statutory provision; and

(iii) statutory provisions of which the statutory provision is an amendment, modification, substitution, consolidation or re-enactment.

Unless the context of this Agreement otherwise requires,

(i) words of one gender includes the other gender;

(ii) words using the singular or plural number also include the plural or singular number respectively;

(iii) the terms “hereof”, “herein”, “hereby” and derivative or similar words refer to this entire Agreement; and

(iv) the terms “Clause” and “Appendix” refer to the specified Clause and Appendix of this Agreement.

When this Agreement refers to a number of days, unless otherwise specified (as business days in which case reference shall be made to normal UK working days), such number shall refer to calendar days. When this Agreement refers to a number of years and/or months, unless otherwise specified, such number shall refer to calendar years and/or months.

2. GRANT OF RIGHTS TO THE PRODUCTS

2.1. GW hereby grants to Bayer an exclusive distribution right to sell, offer for sale, market, promote and distribute the Products in the Territory. GW undertakes during the term of this Agreement not itself to sell, dispose of, or offer to dispose of, offer for sale, market, promote and distribute the Products in the Territory or to purport to grant others the right to do so, other than pursuant to Clause 6.6 and Clause 22.1 b).

2.2. Subject to Clause 2.4, GW hereby grants to Bayer an exclusive license under the GW IPR in the Products strictly to the extent necessary for Bayer to sell, offer for sale, market, promote and distribute the Products in the Territory.

2.3. Bayer shall be entitled to sub-license any and all of its rights hereunder to its Affiliates for each country of the Territory provided that Bayer shall procure that such Affiliates comply with Bayer’s obligations, liabilities and responsibilities under this Agreement. Bayer and its Affiliates shall be entitled at any time to retain one or more Third Party contract sales force(s) to detail, sell, promote and distribute the Products in any country in the Territory provided that the agreement with such Third Party contract sales force is in compliance with Bayer’s obligations and responsibilities under this Agreement.

2.4. In the event that GW fails to meet its obligations under Clause 2.1 of the Supply Agreement and the provisions of Clause 8.2.5 of the Supply Agreement apply, then GW will grant to Bayer (only for the duration of GW’s supply problems or Bayer’s out of stock situation, whichever is longer, as envisaged in Clause 8.2.5 of the Supply Agreement) a royalty-free sole licence with the right to sub-license under the GW IPR in relation to the Products in the Territory to manufacture or to have manufactured the Products in accordance with the provisions set out in Clause 8.2 of the Supply Agreement. For the avoidance of doubt ‘sole’ shall mean that the rights under the GW IPR in relation to the Products under this Clause 2.4 may be exercised within the Territory by GW and Bayer, but that GW shall not appoint any other licensee in the Territory in relation to the rights granted under this Clause 2.4 for the duration of the aforementioned sole licence. Bayer shall not be obliged to obtain GW’s prior written consent to a sub-licensee provided that Bayer shall procure that such sub-licensee acts or refrains from acting in such a manner so as to enable Bayer to comply with Bayer’s obligations, liabilities and responsibilities under this Agreement.

3. TERRITORY OPTION PROCEDURE

3.1. As at the Effective Date, the Territory is the UK Territory. At any time between the Effective Date and 30 September 2003 Bayer may opt to add to the Territory certain further countries (from other countries in the EEA, Canada, Australia and New Zealand) and on the agreed respective Launch Conditions to be set out in Part B of Appendix 3 to this Agreement and otherwise subject to the terms of this Agreement, including without

limitation Clause 3.2 below. Failure to agree any respective Launch Conditions by 30 September 2003 will result in GW being free to enter into a binding agreement with one or more Third Parties with respect to such countries unless the Parties shall have mutually agreed in writing to an extension to finalise such terms.

3.2. For the purposes of calculating the milestone payments attributable to additional countries added to the Territory under the Territory Option Procedure, the total milestone payments with respect to the UK Territory is deemed to be *** pounds sterling (£***). In the event that further countries are added to the Territory in accordance with the procedure set out in Clause 3.1 above, the sums payable with respect to those further countries shall be prorated according the ratio of peak annual sales (to be agreed in writing between the Parties) between the UK Territory and the country(ies) so added, and shall be in the proportions detailed in Appendix 3, Part A2 1 to 3 provided, however, that there shall be no signing fee payable upon addition of further countries to the Territory. By way of example, were a country to be added to the Territory with one half the peak annual sales compared to the UK Territory, the total milestones payable for achievement of the milestones under Part A2 1 to 3 shall be £*** and split between the milestones in the following way: ***.

3.3. Notwithstanding any specific provision in this Agreement or in the Supply Agreement, the Parties undertake to negotiate in good faith any adjustments to the provisions of this Agreement or the Supply Agreement reasonably requested by either Party for countries added to the Territory under the Territory Option Procedure set out in this Clause 3.

4. PAYMENTS

4.1. In consideration for the grant by GW to Bayer of the rights under this Agreement in relation to the Products in the UK Territory an amount of five million pounds sterling (£5 million) shall become due on the Effective Date concurrently with the signature of this Agreement. GW shall issue Bayer with an invoice therefor. Within five (5) business days of receipt of such invoice, Bayer shall forward the payment to GW by bank transfer to such GW account as shall be nominated by GW in writing. Subject to Clause 13.1, the said sum shall be non-refundable and non-creditable to Bayer.

4.2. As further consideration for the grant by GW to Bayer of the rights under this Agreement in relation to the Products in the UK Territory and with respect to countries added to the Territory under the Territory Option Procedure, Bayer shall make payments to GW in the specified incremental amounts and against achievement of the specified milestone events, set out in Appendix 3 to this Agreement, provided that:

(i) each milestone event for which payment hereunder shall be made shall have the particular meaning specified in Appendix 3 to this Agreement;

(ii) in the event the milestone payment specified in Appendix 3 A1.2 becomes due and payable and Bayer shall exercise the Option pursuant to the Subscription Option Agreement, Bayer shall be released from its obligation to pay the milestone payment specified in Appendix 3 A1.2 by such amount as is equal to the amount by which the aggregate subscription monies Bayer pays to GWP pursuant to Clause 3.2 of the Subscription Option Agreement exceeds the then outstanding balance of monies due under the Loan Agreement at such date (and which have been repaid by way of set-off against Bayer’s obligations arising pursuant to Clause 3.2 of the Subscription Option Agreement in accordance with Clause 6.3 of the Loan Agreement);

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(iii) a payment for a milestone event shall be made only one time regardless of how many times such milestone event is achieved, and no payment shall be owed for a event which is not reached;

(iv) more than one milestone payment may be made at a time if more than one milestone event has occurred at the same time;

(v) subject to Clause 13.1 and Clause 13.2 (iii), each such milestone payment shall be non-refundable and non-creditable to Bayer, provided that milestone payments shall not become due if notice of termination was given by a Party entitled to do so prior to the due date of any such milestone payments;

(vi) no later than ten (10) business days after the achievement of each milestone event, GW shall notify Bayer in writing of the achievement of same and GW shall issue a suitable invoice therefore. Within fifteen (15) business days of receipt of such invoice, Bayer shall forward the appropriate milestone payment to GW;

(vii) each payment shall be made in sterling by bank transfer to such GW account as shall be nominated by GW in writing from time to time.

4.3. All sums herein are expressly stated as exclusive of Value Added Tax or equivalent sales tax applicable in the Territory (“VAT”). If VAT is or may become properly payable or chargeable in respect of any payments hereunder, then GW will promptly provide a valid VAT invoice to Bayer. If the VAT charged to and paid by Bayer is subsequently refunded by any relevant fiscal authorities to GW, then such refund shall be promptly forwarded to Bayer with a valid VAT credit note.

5. DEVELOPMENT OBLIGATIONS

5.1. During the term of this Agreement, GW shall have full control and authority, with full responsibility, over the research and clinical development relating to the Products and, in accordance with Clause 7 below, obtaining Marketing Authorisations of the Products in the Territory, and, other than as provided in Clause 5.3 below, all such activity shall be undertaken at GW’s expense. GW will exercise reasonable efforts and diligence in developing the Products to facilitate Bayer’s obligations to commercialise the same.

5.2. All clinical or other studies required by any Medicinal Products Regulatory Authority and as essential to secure Marketing Authorisations for the Products in the Territory (for the two indications listed in Appendix 1 and the indication of the relief of cancer pain) shall be undertaken by GW at its own expense.

5.3. Where clinical or other studies in respect of the Products which are not essential to secure or maintain the Marketing Authorisations are requested in writing by Bayer for commercial purposes or to support a submission to a Treatment Endorsement Body other than in relation to the UK Territory then GW shall undertake such studies at Bayer’s expense. The Parties may agree in writing that Bayer undertakes such studies at its own expense. For the avoidance of doubt, these provisions include all Phase IIIb and Phase IV studies.

6. COMMERCIALISATION OBLIGATIONS

6.1. Subject to a different decision by the Contract Governance Committee, Bayer shall commence sales of the Products within six (6) months of the grant of Marketing Authorisation for the Products in the UK Territory and within six (6) months of the fulfilment of the Launch Conditions in other countries within the Territory, provided, however, that Bayer was in receipt of Launch stocks of the Products as provided by the Supply Agreement in sufficient time prior to the commencement of sales in accordance with this Clause 6.1 and that Bayer had obtained any other approval required from a Governmental Authority (including without limitation a Controlled Drugs Authority) required to sell the Products in the Territory on a commercial basis.

6.2. The Parties shall establish within five (5) business days of the Effective Date in the case of the UK Territory and before 30 September 2003 in the case of each country added to the Territory under the Territory Option Procedure a Country Commercialisation Committee in each country within the Territory. Each Country Commercialisation Committee shall meet upon request by either Party until one (1) year after the Launch on at least a quarterly basis and thereafter on at least a bi-annual basis. In the event of a dispute within a Country Commercialisation Committee, the dispute (except with respect to disputes relating to setting the Sales Targets (as defined below) whereby disputes in relation thereto shall be settled by the procedure set out in Clause 17) will first be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the dispute within thirty (30) days from the date that written notice initiating this resolution process is sent to the other Party. In the event that the Contract Governance Committee cannot resolve the dispute, the decision of Bayer shall be final. The duties of each Country Commercialisation Committee shall include the setting and monitoring in good faith of appropriate and reasonable sales performance levels for the country in question for each agreed twelve (12) month sales period (“Sales Targets”).

6.3. Bayer shall use all reasonable endeavours to meet the Sales Targets.

6.4. Without prejudice to Clause 6.3 above, Bayer shall and shall procure that its Affiliates market and promote the Products using such efforts as Bayer would use for a product of its own making which has the same technical, regulatory and commercial potential to the Products having reasonable regard at all times to the stage at which the relevant Product has reached in its life cycle and the time that has elapsed since Launch; the number of years remaining to loss of exclusivity; competing products; the regulatory environment and reimbursement status of the Products. Such marketing and promotion shall be in accordance with the valid Marketing Authorisations and any variations thereof applicable from time to time and all applicable Laws in each country of the Territory.

6.5. Without prejudice and subject to Clauses 6.2 to 6.4 inclusive above, Bayer and its Affiliates shall maintain sufficient resources (either its own employees or through permitted sub-contractors) during the term of this Agreement to detail, sell, distribute and promote the sale of the Products in the Territory.

6.6. In the event that Bayer may be reasonably considered to have ceased or suspended commercialisation of the Products in one or more countries of the Territory, GW shall raise and reasonably substantiate GW’s complaint within the Country Commercialisation Committee. If such discussion cannot be resolved within the Country Commercialisation Committee, it will be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the discussion within thirty (30) days from the date that it was notified accordingly. In the event that the Contract Governance Committee cannot resolve the discussion and that Bayer may be reasonably considered to have ceased or suspended commercialisation of the Products in one or more countries of the Territory , the following shall apply: In the event that (a) Bayer did not achieve in the preceding *** month period prior to the complaints first being raised by GW within the Country Commercialisation Committee total Net Sales levels throughout the countries concerned of at least *** percent (***%) of those Net Sales achieved by Bayer in the *** month period immediately prior to the *** month period specified above, and (b) GW can demonstrate to Bayer’s reasonable satisfaction that such sales development has not been caused by reasons out of Bayer’s or its Affiliate’s control, each and every of the licences and rights granted under this Agreement for such country shall become non-exclusive immediately upon written notice by GW to Bayer to this effect.

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In the event that in each of the *** month periods prior to the complaints first being raised by GW within the Country Commercialisation Committee total Net Sales throughout the countries concerned amount to *** percent (***%) or less of the total Net Sales achieved by Bayer in the consecutive *** month periods immediately preceding each of such periods and GW can demonstrate to Bayer’s reasonable satisfaction that this event has not been caused by reasons out of Bayer’s control each and every of the licences and rights granted under this Agreement for such country shall terminate upon written notice by GW to Bayer with immediate effect. For avoidance of doubt, it is understood between the Parties that the foregoing does not apply in the event of *** month period *** month periods.

6.7. Bayer agrees during the term of this Agreement to comply with, and not to take any action which would be subject to penalty under all Laws applicable to this Agreement in any country within the Territory, and to conduct its business in accordance with all applicable ethical business practices and Good Distribution Practice.

6.8. Bayer shall at its own cost and expense be responsible for all the preparation and certification of Promotional Materials and marketing, advertising and promoting of the Products in the Territory. Bayer shall provide to GW, through the mechanism of the Country Commercialisation Committee, draft documents containing the key promotional messages forming the basis of Bayer’s core marketing claims at an early stage in Bayer’s preparation of its core marketing claims having regard to GW’s position and responsibilities as Marketing Authorisation holder and in the event of a dispute between the Parties the procedure in Clause 17 below shall apply. The Products, packaging materials and Promotional Materials based on the foregoing key promotional messages shall properly and clearly state that such are sold under license from GW and prior to release in a country of the Territory the finalised Promotional Materials will have been approved in writing by the relevant Country Commercialisation Committee. Bayer shall provide copies of the finalised Promotional Materials to GW as soon as possible. GW will provide Bayer or its Affiliates SmPC text revisions as timely as possible to allow preparation of promotional materials.

6.9. Without prejudice to the provisions of Clause 6.7 above, Bayer shall ensure that no claims or representations in respect of the Products or the characteristics thereof are made by or on behalf of it (by its agents or subcontractors or otherwise) which do not represent an accurate summary or explanation of the labelling of the Products or SmPC or a portion thereof.

6.10. Bayer shall comply in all material respects with applicable Laws in each country of the Territory (including without limitation with the Association of the British Pharmaceutical Industry (ABPI) Code of Practice and all regulations under the Medicines Act 1968 (as amended)) in its promotional activities in relation to the Products.

6.11. Bayer shall not actively seek customers outside the Territory in connection with the Products.

7. REGULATORY OBLIGATIONS

7.1. GW will be solely responsible for applying for (including responding promptly to all requests from the Medicinal Products Regulatory Authority in the Territory in relation to such application) and maintaining the Marketing Authorisations required in each country of the Territory in order to enable the marketing, distribution and sale of the Products. GW will provide to Bayer or its Bayer Affiliates copies of any Marketing Authorisation documentation reasonably necessary to enable Bayer’s Affiliates to meet their obligations as named distributor in the relevant Territory.

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7.2. Within five (5) business days of the Effective Date the Parties shall establish a Regulatory Collaboration Committee for all regulatory matters relating to Product in the Territory and the countries covered by the Territory Option Procedure. The Regulatory Collaboration Committee shall also consider the strategy for obtaining Marketing Authorisations under the EC mutual recognition procedure in concerned member states and in other countries of the Territory. The Regulatory Collaboration Committee shall meet upon request by either Party until one (1) year after the Launch on at least a quarterly basis and thereafter on at least a semi-annual basis. In the event of a dispute within the Regulatory Collaboration Committee, the dispute (except with respect to disputes relating to the review of proposed submissions according to Clause 7.5 in which case disputes shall be settled by the procedure set out in Clause 17) will first be referred for resolution to the Contract Governance Committee who will attempt in good faith to resolve the dispute within thirty (30) days from the date that written notice initiating this resolution process is sent to the other Party. In the event that the Contract Governance Committee cannot resolve the dispute, the decision of GW shall be final with the exception of decisions that have a significant impact on the commercialisation of the Product in the Territory.

7.3. GW and Bayer or its Affiliates shall share responsibility for submissions to any Treatment Endorsement Bodies in the UK Territory in respect of the Products provided that the Parties shall each contribute *** percent (***%) of costs reasonably incurred in obtaining an endorsement in relation to any of the Products from the relevant Treatment Endorsement Body. In relation to submissions to Treatment Endorsement Bodies in any other country of the Territory these will be made by, and at the sole expense of Bayer. Each applicant to a Treatment Endorsement Body shall use its reasonable endeavours to secure as far as is possible endorsement which is mutually satisfactory to each of the Parties in relation to the use of the Products PROVIDED ALWAYS THAT if there is no or insufficient clinical or other data to support such submission the Parties shall discuss and agree additional studies to be undertaken by GW on a shared cost basis or at Bayer’s cost (as the case may be) required to generate the data and other information required to be included within the submissions to Treatment Endorsement Bodies. The Parties may agree that such studies may be performed by Bayer or its Affiliates at their own expense. Prior to any submission to a Treatment Endorsement Body, the applicant shall provide Regulatory Collaboration Committee with copies of its proposed submissions. The Regulatory Collaboration Committee shall review such proposed submissions and ensure that the impact of any decisions regarding the contents of the application to the Treatment Endorsement Body is not detrimental to either Party’s interests.

7.4. Subject to Clause 7.5, GW will be the sole and beneficial owner of any Marketing Authorisations for the Products. Upon receipt of the initial Marketing Authorisations for the Products GW shall be responsible for the maintenance and seeking revisions and variations of each such Marketing Authorisations for the Products at its cost and shall discuss such revision or variation with the Regulatory Collaboration Committee.

7.5. The Parties shall mutually agree to transfer a Marketing Authorisation to a Bayer Affiliate if a local presence is required by law in a country within the Territory and that GW does not have such presence in such country. In the event that a Marketing Authorisation is held by a Bayer Affiliate, the Parties shall in good faith agree upon provisions reflecting the aforesaid principle and Bayer shall procure that the Bayer Affiliate in question promptly accedes to and cooperates in any request by GW that the Marketing Authorisation be transferred to GW or its nominee or in any equivalent procedure.

7.6. Bayer acknowledges that GW has prior to the Effective Date made applications to the UK Medicines and Healthcare Products Regulatory Agency (“MHRA”) for Marketing

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Authorisations in the UK Territory for the Products. Prior to any submissions to any other Medicinal Products Regulatory Authority in the Territory in relation to a Marketing Authorisation, GW shall provide the Regulatory Collaboration Committee with copies of its proposed submissions including any changes or modifications to the label or labelling for, or the Indications for the Products. The Regulatory Collaboration Committee shall review such proposed submissions and ensure that the impact of any decisions regarding regulatory strategy or revisions to the Marketing Authorisations is not detrimental to either Party’s commercial and marketing strategy for the Products.

7.7. Upon receipt of questions from MHRA in UK Territory, GW will discuss within the Regulatory Collaboration Committee proposed responses and implications for SmPC wording. GW will respond to deficiency questions and undertake additional studies to secure the initial Marketing Authorisation SmPC in accordance with the decisions made by the Regulatory Collaboration Committee in a timely manner.

7.8. In respect of countries of the Territory, GW will request artwork input from Bayer or its Affiliate for the pack design, packaging, and labelling for the Products at Bayer’s cost. GW shall have sole authority and responsibility to seek and/or obtain any necessary Medicinal Products Regulatory Authority approvals of any label, labelling, patient information leaflets, monographs and packaging used in connection with the Products, and for determining whether the same requires Medicinal Products Regulatory Authority approval. Upon request by GW, Bayer shall collaborate with GW through the provision of reasonable assistance in seeking and obtaining such approvals.

7.9. Each Party agrees to provide the other with all reasonable assistance and take all actions reasonably requested by the other that are necessary or desirable to enable the other Party to comply with any Laws in any country of the Territory applicable to the Products, including but not limited to, GW meeting its reporting and other obligations to maintain and update any Marketing Authorisations for the Products. GW shall send to Bayer or its Affiliates copies of all relevant Marketing Authorisation(s) and amendments within a reasonable timeframe of their grant or coming into effect.

7.10. In respect of the UK Territory, provisions relating to Adverse Event Reporting obligations will be agreed separately in writing within forty-five (45) days following the Effective Date by the Parties and their respective central Safety Departments. Adverse Event Reporting in the UK Territory shall be at GW’s cost. Outside the UK Territory, subject to Clause 3, Bayer shall carry out Adverse Event Reporting at costs to be agreed under the territory option procedure in Clause 3.1 and provide GW with access to all information necessary for GW to fulfil its obligations as Marketing Authorisation holder.

7.11. The Parties shall agree separately as part of the Adverse Event Reporting obligations on the responsibilities to responding to enquiries for medical information from healthcare professionals, its medical representatives, other medical organisations or societies and any Governmental Authorities in respect of matters relating to the indicated use of the Products as provided in the then current Marketing Authorisation within the UK. Outside the UK, subject to Clause 3, Bayer shall be responsible for medical information at Bayer’s cost. GW shall ensure Bayer has sufficient clinical data and supporting information to respond to all such enquiries. GW shall provide to Bayer or its Affiliates the current SmPC in order to carry out the medical information function.

7.12. Subject to a separate agreement on Adverse Event Reporting, Bayer shall provide an update to GW on a quarterly basis providing a detailed summary of medical information enquiries and standard answers that Bayer have developed in response to such enquiries.

7.13. The Parties shall only implement a market withdrawal or recall of any of the Products upon mutual agreement, provided that nothing shall oblige either Party to be in breach of any of its legal or other obligations.

7.14. GW shall be responsible for updating compendia (MIMS, BNF, EMC for the UK Territory and any additional compendia to be agreed between the Parties) in the Territory.

8. CONFIDENTIALITY AND ANNOUNCEMENTS

8.1. During the term of this Agreement and for seven (7) years thereafter, irrespective of any termination earlier than the expiration of the term of this Agreement and without prejudice to GW’s rights to data exclusivity rights under Article 10.1.a. (iii) of Council Directive (EC) 2001/83, GW and Bayer shall not use or reveal or disclose to Third Parties any confidential information received from the other or otherwise developed by either of Bayer or GW in the performance of activities in furtherance of this Agreement without first obtaining the written consent of the disclosing Party (and any such disclosure shall be on terms equivalent to those herein), except as may be otherwise provided herein. This confidentiality obligation shall not apply to such information which is or becomes a matter of public knowledge, or is already in the possession of the receiving Party, or is disclosed to the receiving Party by a Third Party having the right to do so, or is required by law to be disclosed. The Parties shall ensure that others to whom access to such information is granted make no unauthorised use or disclosure.

8.2. Nothing herein shall be construed as preventing Bayer or GW from disclosing any information received from the other to an Affiliate provided that the receiving Party procures that the Affiliate in question complies with confidentiality obligations equivalent to those herein.

8.3. All confidential information disclosed by one Party to the other should remain the Intellectual Property Rights of the disclosing Party. In the event that a court or other legal or administrative tribunal, directly or through an appointed master, trustee or receiver, assumes partial or complete control over the assets of a Party to this Agreement based on the insolvency or bankruptcy of such Party, the bankrupt or insolvent Party shall promptly notify the court or other tribunal (i) that confidential information received from the other Party under this Agreement remains the property of the other Party and (ii) of the confidentiality obligations under this Agreement. In addition, the bankrupt or insolvent Party shall, to the extent permitted by law, take all steps necessary or desirable to maintain the confidentiality of the other Party’s confidential information and to ensure that the court, other tribunal or appointee maintains such information in confidence in accordance with the terms of this Agreement.

8.4. No public announcement or other disclosure to Third Parties concerning the existence of or terms of this Agreement shall be made, either directly or indirectly, by either Party to this Agreement, except as may be legally required or as may be required for financial reporting or recording purposes, without first obtaining the approval of the other Party and agreement upon the nature and text of such announcement or disclosure and the other Party shall either give such approval or reasonable and substantial reasons for refusal within two business days of the date approval was first sought for the said announcement. Even in circumstances where approval of the other Party is not to be sought for legal, financial reporting or recording purposes, the Party making the announcement or disclosure shall provide the text to the other at least forty eight (48) hours in advance of publication. The Party desiring to make any such public announcement or other disclosure requiring the other Party’s approval shall inform the other Party of the proposed announcement or disclosure in reasonably sufficient time prior to public release, and shall provide the other Party with a written copy thereof, in order to allow such other Party to approve upon such announcement or disclosure. Once a Party has received consent to the text submitted by it to the other Party for public announcement or disclosure, the submitting Party may use the same or equivalent text for similar purposes without requiring further consent from the other Party providing the initial text is not materially varied, without further consent being sought from the other Party.

8.5. Bayer shall not submit for written or oral publication any scientific manuscript, abstract or the like which includes data or other information relating to the Products without first obtaining the prior written consent of GW, which consent shall not be unreasonably withheld or delayed. Bayer shall send such publications to GW and within thirty (30) business days of the receipt of the request GW shall give the consent or provide reasonable and substantial reasons for refusal, provided, however, that such submission and consent shall not be required for spin-off publications which are materially similar to publications that were previously approved by GW. The contribution of each Party shall be duly noted in all publications or presentations by acknowledgement or co-authorship, whichever is appropriate.

8.6. Nothing in this Agreement shall be construed as preventing or in any way inhibiting GW or Bayer from complying with statutory and regulatory requirements governing the manufacture, use and sale or other distribution of the Products in any manner which it reasonably deems appropriate, including, for example, by disclosing to regulatory authorities confidential or other information received from the other Party or Third Parties.

8.7. All media and press enquiries received by GW relating to the promotion and sale of the Products in the Territory by Bayer shall be referred to Bayer who shall promptly and appropriately respond to such enquiries. Any such enquiries or responses or equivalent enquiries received by Bayer relating to the Products that could impinge on GW’s responsibilities and obligations as holder of the Marketing Authorisation or be detrimental in any way to GW shall be discussed and agreed with GW promptly prior to Bayer responding to such media enquiry.

9. INTELLECTUAL PROPERTY RIGHTS OWNERSHIP, PATENT PROSECUTION AND LITIGATION

9.1. Each Party shall have and retain sole and exclusive title to their respective Background Rights. For the avoidance of doubt, GW shall have and retain sole and exclusive title to all Foreground Rights which are made, conceived, reduced to practice or generated in the course of or as a result of this Agreement. In the case of any Foreground Rights that may arise from the activities of Bayer during the course of this Agreement, Bayer shall promptly disclose and assign such Foreground Rights to GW and do all acts which GW shall reasonably require of Bayer to vest the property of such Foreground Rights in GW at GW’s expense. GW shall grant to Bayer a non-exclusive, royalty—free, perpetual, irrevocable licence to exploit the same in the Territory.

9.2. GW warrants and represents that it has disclosed to Bayer the complete texts of all patent applications filed by GW as of the Effective Date which relate to the Products as well as all information received by GW as of the Effective Date concerning the institution or possible institution of any opposition, re-examination, reissue, revocation, nullification or any official proceeding involving the GW IPR in the Territory. GW further warrants and represents that it will disclose to Bayer the complete texts of all patent applications filed by GW after the Effective Date which relate to the Products in the Territory, or outside the Territory if such application could affect the validity of the GW IPR in the Territory, as well as all information received by GW after the Effective Date concerning the institution or possible institution of any, opposition, re-examination, reissue, revocation, nullification or any official proceeding involving any GW IPR. GW shall be responsible at its own cost for filing, prosecution, maintenance and renewal of the GW Patents. GW agrees to keep Bayer informed of the course of patent prosecution or other proceedings. In such circumstances, Bayer may provide patent consultation to GW at no cost to GW. Bayer shall hold all information disclosed to it under this Clause as confidential subject to the provisions of Clauses 8.2 and 8.3 above.

9.3. Bayer shall have the right, but not the obligation, to assume responsibility at its cost for any GW Patent or any part of a GW Patent in the Territory, which GW states to Bayer in writing that it intends to abandon or otherwise cause or allow to be forfeited. GW shall give Bayer

reasonable written notice prior to abandonment or other forfeiture of any such GW Patent or any part of such GW Patent so as to permit Bayer to exercise its rights under this Clause 9.3 in respect of the Products.

9.4. In the event of the institution of any suit by a Third Party against GW or its Affiliates or Bayer or its Affiliates for patent or other Intellectual Property Rights infringement involving the manufacture, use, sale, distribution or marketing of the Products in accordance with this Agreement the Party sued shall promptly notify the other Party in writing and Bayer shall make no admission. GW shall take all appropriate action to defend such suit at its own expense. GW shall have sole conduct of such defence. GW and Bayer shall provide reasonable assistance to one another and reasonably co-operate in any such litigation at the other’s request without expense to the requesting Party. Any costs agreed to in advance in writing by GW and reasonably incurred by Bayer in defending such litigation shall be invoiced by Bayer to GW and shall become payable within thirty (30) days from receipt of invoice. In circumstances where the alleged infringement is upheld through the legal proceedings and/or the Third Party is unable or unwilling to grant a licence of its Intellectual Property Rights to prevent future infringement despite the Parties using their respective best efforts to obtain the same, the parties shall meet and discuss in good faith how to proceed.

9.5. In the event that GW or Bayer becomes aware of actual or threatened infringement or validity attacks of GW IPR in the Territory, that Party shall promptly notify the other Party in writing. Bayer shall have the first right, but not the obligation, to bring, at its own expense, an infringement action against any Third Party in the Territory and to use GW’s name in connection therewith and to name GW as a party thereto. If Bayer does not commence a particular infringement action within thirty (30) days of receipt of the notice of infringement, then GW, after notifying Bayer in writing, shall be entitled to bring such infringement action at its own expense. The Party conducting such action shall have full control over its conduct, including settlement thereof subject to Clause 9.8 below provided always that that Party shall not bear any part of the settlement payments unless that Party has been involved in and agreed to the settlement.

9.6. Subject to the other provisions of this Clause 9, in any action brought pursuant to Clause 9.5 above, the Party bringing the action shall indemnify the other Party, its officers, directors, shareholders, employees, agents, successors and assigns from any loss, damage or liability, including for attorney’s fees and costs, which may result from claims, counterclaims or cross claims asserted by a defendant, except to the extent that such losses, damages or liabilities result from the negligence or wilful misconduct or breach of this Agreement of the other Party.

9.7. GW and Bayer shall recover their respective actual out-of-pocket expenses, or equitable proportions thereof, associated with any litigation or settlement thereof from any recovery made by either Party. Any excess amount shall be shared equally between Bayer and GW.

9.8. The Parties shall keep one another informed of the status of and of their respective activities regarding any litigation or settlement thereof concerning the Products, provided however that no settlement or consent judgement or other voluntary final disposition of any suit defended or action brought by a Party pursuant to this Clause 9 may be entered into without the consent of the other Party or to make a monetary payment or would otherwise adversely affect the other Party’s rights under this Agreement.

9.9. Notwithstanding the generality of Clause 16.2, if, during the term of this Agreement, Bayer and GW agree in writing whether it is necessary to seek a license from any Third Party in order to avoid infringement of Third Party IPR in any part of the Territory during the exercise of the license or distribution right granted herein, GW shall seek such a license in

full co-operation with Bayer. GW shall be responsible for the payment of any royalties or other fees paid to such Third Party directly but *** percent (***%) of any royalties or other fees paid to such Third Party by GW under such license shall be the liability of Bayer and shall be payable by Bayer within thirty (30) days of receipt of an invoice from GW.

10. TRADE MARKS AND PRODUCT MARKING

10.1. GW hereby grants to Bayer a sole license to use the Trade Marks in the Territory to the extent necessary for Bayer to fulfil its obligations under this Agreement.

10.2. Bayer hereby grants to GW the right to use the Bayer logo on the artwork and labelling for the Products during the manufacture in a manner, style and colour as specified by Bayer. GW shall have no rights in the Bayer logo and agrees that upon termination or expiration of this Agreement or for the period of a cessation of supply under the provisions of Clause 8.2.5 of the Supply Agreement it will discontinue within thirty (30) days of use of the Bayer logo and will at the request of Bayer and at its own expense submit applications to the relevant Governmental Authority to remove the Bayer logo from the relevant Marketing Authorisation and related patient information leaflet and SmPC.

10.3. GW shall be responsible at its own cost for the registration, renewal and maintenance including, but without limitation, in relation to oppositions of all registrations and applications for the Trade Marks in the Territory. GW shall, take all necessary steps to protect the Trade Marks by way of further registrations having regard to the commercial importance of the Trade Marks to both parties and to the use made or to be made of the Trade Marks. The provisions of Clause 9.5 above shall apply in relation to the enforcement and defence of the Trade Marks mutatis mutandis.

10.4. Nothing in this Agreement shall be construed as a grant of rights, by license or otherwise, to either Party to use any other trade marks owned by the other Party for any purpose.

10.5. Bayer shall not by virtue of this Agreement obtain or claim any right, title or interest in or to the Trade Marks except the rights of use which are specifically set out in this Agreement. Bayer hereby acknowledges and agrees that the benefit of all such use shall belong to GW. GW hereby reserves all rights and powers not expressly granted to Bayer hereunder. All goodwill arising in relation to the use of the Trade Marks shall accrue to GW. Upon request, Bayer shall execute all documents requested by GW in order to confirm this.

10.6. All products on or in relation to which Bayer uses the Trade Marks, shall be of the highest professional quality and in any event of a quality at least equal to those on or in relation to which Bayer used any trade mark in the twelve (12) months prior to the Effective Date and subject to any guidelines issued by GW to Bayer from time to time. This Clause shall not limit the provisions of Clauses 10.9 to 10.12 below.

10.7. Bayer shall ensure that its use of the Trade Marks conforms to and complies with:

(a) the standards, regulations and other provisions specified in this Agreement;

(b) all good practice requirements relating to or affecting the same and all applicable Laws; and

10.8. At GW’s request from time to time Bayer shall provide GW with samples of its use of the Trade Marks.

10.9. Bayer shall not :

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(a) use the Trade Marks in a manner which is likely to cause harm to the goodwill attached to it;

(b) use the Trade Marks in any manner which would bring the Trade Marks or GW into disrepute;

(c) use the Trade Marks in any manner which would jeopardise or invalidate any registration (or prejudice any application for registration) of the Trade Marks or could assist or give rise to an application to terminate or revoke any registration; and/or

(e) use the Trade Marks in any manner which might prejudice the right or title of GW to the Trade Marks.

10.10. Except as expressly permitted or required in this Agreement, Bayer shall not use the Trade Marks accompanied by other words or other trade marks, whether registered or not, nor by words describing products and services within the scope of the licence granted in Clause 10.1 above, unless in each case the Trade Marks are sufficiently distinguished from the surrounding text.

10.11. Bayer shall clearly identify GW as the owner or (if applicable) the registered proprietor of the Trade Marks where used by Bayer.

10.12. Bayer shall not adopt or use any trade mark, symbol, device, service mark, domain name or company, business or trading name which incorporates or is confusingly similar to the Trade Marks except as expressly permitted or required in this Agreement. Bayer shall not at any time, whether during or after the termination of this Agreement, apply anywhere in the world to register any trade marks, service marks, domain names or company, business or trading names identical to or so nearly resembling the Trade Marks as to be likely to deceive or cause confusion.

10.13. Bayer shall submit any proposed representation of the Trade Marks to GW for GW’s approval, such approval not to be unreasonably withheld or delayed.

10.14. All Promotional Materials, Products and packaging shall properly and clearly indicate that the Products are sold under license from GW.

10.15. GW shall own any registered domain name containing either of the Trade Marks or any other trade mark or service mark referred to above. Bayer shall be entitled to operate the web sites under such domain names in the Territory for the duration of this Agreement soley for the purpose of performing its obligations and enjoying its rights hereunder.

11. STATEMENTS AND REMITTANCES

11.1. Bayer shall keep and shall require its Affiliates to keep complete and accurate records of all sales of the Products in each country of the Territory. GW shall have the right, at GW’s expense, through a certified public accountant or like person reasonably acceptable to Bayer, to examine such records during regular business hours during the term of this Agreement and for six (6) months after its termination; provided, however, that such examination shall not take place more often than once a year and shall not cover such records for more than the preceding two (2) years and provided further that such accountant shall report to GW only as to the accuracy of the Net Sales statements and payments. GW shall pay all costs and expenses incurred in connection with performing any such examination unless the examination discloses at least *** percent (***%) shortfall, in which case Bayer will bear the full cost of such examination.

11.2. Any tax, duty or other levy paid or required to be withheld by Bayer on account of payments

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payable to GW under this Agreement shall be deducted from the payments otherwise due. Bayer shall secure and send to GW proof of any such taxes, duties or other levies withheld and paid by Bayer or its Affiliates for the benefit of GW.

12. TERM AND TERMINATION

12.1. This Agreement shall continue for fifteen (15) years (“Initial Term”), provided that the Agreement shall continue for successive twelve (12) month periods thereafter unless Bayer terminates by serving at least twelve (12) months’ written notice prior to the end of the Initial Term and prior to the end of each successive calendar year after such Initial Term.

12.2. If either Party fails or neglects to perform material covenants or provisions of this Agreement, including as provided for by Clause 2.4 above and Clause 8.2.5 of the Supply Agreement, the other Party shall have the right to terminate this Agreement by giving written notice to the Party in default within sixty (60) days of the default, provided, however, that in the case of a default or breach capable of being cured, if the said defaulting Party shall cure the said default or breach within ninety (90) days after the said notice shall have been given, then the said notice shall not be effective.

12.3. Without prejudice to the generality of Clause 12.2 above and GW’s other rights hereunder GW shall be entitled to terminate this Agreement in its entirety or with respect to an individual Product or country of the Territory with immediate effect in the event that:

(a) Bayer fails to achieve Launch within the timescale required by Clause 6.1 above;

(b) Subject to the provisions of Clause 6 above, Bayer ceases or suspends commercialisation of any of the Products throughout the Territory or in one or more countries of the Territory and has notified GW in writing of its intention in this respect, other than for technical or regulatory reasons as provided in Clause 12.4 below;

12.4. Without prejudice to the generality of Clause 12.2 above and Bayer’s other rights hereunder Bayer shall be entitled to terminate this Agreement in its entirety or with respect to an individual Product or country of the Territory with immediate effect in the event that:

(a) the Medicinal Products Regulatory Authority does not grant to GW a Marketing Authorisation for a Product, provided that Bayer shall not be entitled to exercise such termination right before 30 September 2004;

(b) GW fails to comply with its obligation under Clause 18.1 of the Supply Agreement;

(c) Bayer is forced by Governmental Authority to stop the distribution of Product due to toxicity or safety findings or side effects of Product;

(d) if either Bayer or GW fails to secure a licence from a Third Party to continue marketing any of the Products throughout the Territory or in one or more countries of the Territory as provided under Clause 9.4 above.

12.5. In the event of a withdrawal or suspension of a Marketing Authorisation or restrictions imposed by any Governmental Authority in respect of a Product throughout the Territory or in one or more countries of the Territory GW and Bayer shall meet to discuss and review the terms of this Agreement. In the event of a failure by the Parties to agree revised terms or to resolve the issue to permit a variation or reinstatement of any Marketing Authorisation(s) despite mutual good faith efforts to do so either GW or Bayer shall have the right to terminate this Agreement in relation to the Product in question in all or any of the country(ies) of the Territory governed by the Marketing Authorisation by giving ninety (90) days written notice to the other.

12.6. If either Party shall compound or make any arrangement with its creditors or have a receiver appointed over all or any part of its assets or go into liquidation (whether voluntary

or otherwise) save as part of a bona fide reconstruction not involving insolvency or shall take or suffer to be taken any similar action as a result of its liability to pay its debts or its insolvency it shall promptly so notify the other Party in writing giving particulars of the circumstances whereupon the other Party may terminate the Agreement immediately.

12.7. Notwithstanding the bankruptcy of GW, or the impairment of performance by GW of its obligations under this Agreement as a result of bankruptcy or insolvency of GW, Bayer shall (provided that all payments due to GW from Bayer and its Affiliates hereunder have been made) be entitled to retain the licenses granted herein, subject to GW’s rights to terminate this Agreement for reasons other than bankruptcy or insolvency as expressly provided in this Agreement.

12.8. The Supply Agreement shall automatically terminate at the same time in its entirety in the event that this Agreement shall terminate in its entirety under the terms of this Clause 12. In the event that termination takes place under this Agreement in relation to any Product or any or all of the affected countries of the Territory then the parties shall meet and negotiate in good faith agreed changes to the Supply Agreement consequential on a partial termination of this Agreement under this Clause 12.

13. RIGHTS AND DUTIES UPON TERMINATION

13.1. Upon termination of this Agreement, unless in the event Bayer was entitled to terminate the Agreement based on fraud or wilful default by GW, GW shall have the right to retain all milestone payments scheduled in Appendix 3 to this Agreement already paid by Bayer or due to GW at that time. Bayer shall have no liability to GW in respect of further milestone payments detailed in the said Appendix 3 to this Agreement.

13.2. Upon termination of this Agreement, all licenses granted hereunder to Bayer shall cease and Bayer undertakes not to use any GW IPR, except as may be otherwise provided in this Agreement and the Supply Agreement. Furthermore, promptly after the effective date of such termination, Bayer shall return all tangible GW Know-how including copies thereof to GW to the extent that such is practicable.

13.3. Upon termination of this Agreement in its entirety or with respect to any Products or countries of the Territory under Clause 12.3 above, Bayer shall notify GW of the amount of the Products Bayer and its Affiliates have on hand and Bayer and its Affiliates, shall thereupon be permitted to sell those amounts of the Products for a period of up to one hundred and eighty (180) days after termination provided that Bayer shall pay the payments thereon at the time herein provided for. GW at its option may repurchase the products Bayer and its Affiliates have on hand by reimbursing to Bayer the Supply Price. The Parties agree to negotiate in good faith all regulatory steps required upon such termination and undertake to initiate such steps subsequently.

13.4. Termination of this Agreement in its entirety shall terminate all outstanding obligations and liabilities between the Parties arising from this Agreement except those described in Clauses 4, 7.9, 8, 9, 10, 11, and 17 hereof, and any other obligations otherwise provided by this Agreement which have accrued or have application beyond the term of this Agreement. In addition, any other provision required to interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement.

13.5. Termination of the Agreement in accordance with the provisions hereof shall not limit remedies, which may be otherwise available in law or equity.

13.6. Except as required under Clause 13.3 above, Bayer shall immediately cease use of the Trade Marks upon termination of this Agreement in its entirety or in relation to any one or more Products or countries of the Territory, entirely or in relation to that Product or country of the Territory, as the case may be.

14. WARRANTIES AND REPRESENTATIONS

14.1. GW warrants and represents that it has the right to enter into this Agreement and to the best of its knowledge and belief that with respect to the Products it owns or controls the entire right, title and interest in the GW IPR and the Trade Marks.

14.2. GW warrants and represents that any GW IPR and any Trade Marks is not encumbered with liens, mortgages, security interests or otherwise. GW further warrants and represents that to the best of its knowledge and belief there is nothing in any Third Party agreement GW has entered into as of the Effective Date which, in any way, will limit GW’s ability to perform all of the obligations undertaken by GW hereunder with respect to the Products, and that it will not enter into any agreement after the Effective Date under which GW would incur any such limitations.

14.3. GW warrants and represents that in relation to the Products it has no present knowledge as at the Effective Date from which it can be inferred that GW IPR as currently comprised are invalid or that their exercise would infringe Intellectual Property Rights of Third Parties.

14.4. Subject to the provisions of the SmPC which is approved by a Medicinal Products Regulatory Authority, GW warrants and represents that to the best of its knowledge and belief there are no pre-clinical or clinical data or information concerning the Products which suggests that there may exist quality, toxicity, safety and/or efficacy concerns which may materially impair the utility and/or safety of the Products.

14.5. Each Party warrants and represents to the other Party that (i) such Party is duly organised and validly existing under the Laws of the Territory and has full corporate power and authority to enter into this Agreement and carry out the provisions hereof, and (ii) such Party is duly authorised to execute and deliver this Agreement and to perform is obligations hereunder.

15. INDEMNITIES AND LIMITATION; INSURANCE

15.1. Bayer shall indemnify, keep indemnified and hold GW harmless against (a) any and all liabilities, losses, costs and expenses (including reasonable legal fees) relating to Products which result from any and all claims, suits, actions, demands or judgments of third parties, including without limitation personal injury and product liability matters brought against GW, other than to the extent resulting directly from any negligence or material breach of this Agreement or the Supply Agreement by GW, its employees and sub-contractors, or (b) any material misrepresentation, breach of warranty or non-fulfilment of or failure to perform any obligation of Bayer in this Agreement or the Supply Agreement.

15.2. GW shall indemnify, keep indemnified and hold Bayer harmless against any and all liabilities, losses, costs and expenses (including reasonable legal fees) to the extent the same directly result from (a) any and all claims, suits, actions, demands or judgments of third parties, including without limitation personal injury and product liability matters brought against Bayer arising as a result of personal injury or death in respect of any Product not sold or distributed by Bayer, its Affiliates, designated Third Parties, and their respective employees and sub-contractors, including, but not limited to, Products distributed by GW in the course of clinical trials prior to the Effective Date and during the term of this Agreement, (b) any and all Third Party product liability claims made or suits brought against Bayer arising as a result of personal injury or death in respect of any negligence or material breach of this Agreement or the Supply Agreement by GW, its employees and sub-contractors, (c) any material misrepresentation, breach of warranty or non-fulfilment of or failure to perform any obligation of GW in this Agreement or the Supply Agreement, or (d) any negligent act or omission of GW.

15.3. In the event GW or Bayer (the “Indemnified Party”) wants to bring a claim against the other (the “Indemnifying Party”) under the indemnities in this Clause 15, the Indemnified Party shall give prompt written notice to the Indemnifying Party of any claim or threat of claim it

receives with respect of any matter for which it may be entitled to indemnification, the Indemnifying Party shall thereafter defend or settle any such claim at its sole expense, and with counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party. In the defence or settlement of any such claim the Indemnified Party shall co-operate with and assist the Indemnifying Party to the extent reasonably possible, but the Indemnifying Party shall bear and pay any and all expenses incurred by that Indemnified Party in providing such co-operation and assistance, either directly or upon request of the Indemnified Party who has incurred such expense. Failure to give notice shall not constitute a defence in whole or in part to any claim by the Indemnified Party except to the extent the rights of the Indemnifying Party are materially prejudiced by such failure to give notice.

15.4. Notwithstanding the foregoing, should any claim be made by a person not a Party to this Agreement (and not an Affiliate of a Party) with respect to any matter to which the foregoing indemnity relates, a Indemnified Party may make settlement of such claim giving not less than twenty (20) days prior written notice of the proposed terms thereof to the Indemnifying Party provided, however, that if within said twenty (20) day period the Indemnifying Party shall have requested the Indemnified Party not to settle such claim and to deny such claim, the Indemnified Party will promptly comply and the Indemnifying Party shall have the right to defend the claim at its sole expense and with counsel reasonably acceptable to the Indemnified Party.

15.5. Notwithstanding that the Indemnifying Party has assumed the defence of any claim with counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party, the Indemnified Party shall have the right to employ its own counsel, at its sole expense. If in good faith, the Indemnified Party concludes that there are specific defences available to the Indemnified Party which are different from or in addition to those available to the Indemnifying Party, or that such claims may have a material adverse effect on the Indemnified Party, with respect to the scope of the foregoing indemnity, then the Indemnified Party shall have the right to direct the defence of any such claim in consultation with the Indemnifying Party and the Indemnifying Party shall bear the expense of doing so.

15.6. Except as provided for herein, no Indemnified Party will compromise or settle any claims (whether by admission, statements, payments or allowances) nor will it conduct itself in a way that could prejudice the defence of any such claims or threats except where the Indemnifying Party has given its prior written consent therefore.

15.7. The liability of GW under Clause 15.2 shall not exceed the total sum of five (5) million Euro.

15.8. Each party shall maintain at its own cost appropriate third party, public liability and product liability insurance or self insurance to cover its reasonably anticipated liabilities hereunder and grant the other party the right to inspect the insurance certificate.

16. FORCE MAJEURE; HARDSHIP

16.1. If the performance of any part of this Agreement by either Party, or of any obligation under this Agreement, is prevented, restricted, interfered with or delayed by reason of any cause beyond the reasonable control of the Party liable to perform, such as, without limitation: fire, explosion, flood, war, acts of God, acts of terrorism, riot, sabotage, accident, disease, embargo, interruption or delay in production or transportation if such interruption or delay could not be anticipated unforeseeable inadequacy or shortage or failure of supply of raw materials or equipment, unforeseeable breakdown of plant, strike, labour trouble, orders, actions and directives by any authority, unless conclusive evidence to the contrary is provided, the Party so affected shall, upon giving written notice to the other Party, be excused from such performance to the extent of such prevention, restriction, interference or delay, provided that the affected Party shall use its reasonable efforts to avoid or remove such causes of non-performance and shall continue performance with the utmost dispatch

whenever such causes are removed. When such circumstances arise, the Parties shall discuss what, if any, modification of the terms of this Agreement may be required in order to arrive at an equitable solution.

16.2. If as a result of unforeseen events or developments the effect of this Agreement shall cause inequitable hardship for one or both Parties and/or, in the case of Bayer, its Affiliates, which runs counter to the aim of this Agreement and which the one Party cannot reasonably and in good faith expect the other Party to tolerate, the Parties will meet and seek in good faith to find equitable ways to amend the Agreement in order to re-establish the basic economic balance of this Agreement.

17. GOVERNING LAW AND DISPUTE RESOLUTION

17.1. Subject to Clause 17.4, if any disputes, controversies or differences (“dispute(s)”) arising hereunder they will first be referred for resolution, prior to either Party initiating any proceeding, to the Contract Governance Committee who will attempt in good faith to resolve the dispute within ninety (90) days from the date that written notice initiating this dispute resolution process is sent to the other Party (the “Initial Notice”). If, however, the dispute between the Parties has not been resolved within the aforesaid period of ninety (90) from the date of the Initial Notice (the “Initial Period”), the matter will then subject to Clause 17.3 below be finally settled by mediation in accordance with the Centre for Dispute Resolution Model Procedure (“CEDR”) in accordance with Clause 17.2 below.

17.2. To initiate the mediation a Party must give notice in writing (the “ADR Notice”) to the other Party requesting a mediation. The mediation will take place not later than twenty-eight (28) days after the service of an ADR Notice on the other Party. If there is any issue on the conduct of the mediation upon which the Parties cannot agree within fourteen (14) days of the ADR Notice, CEDR will, at the request of either Party, decide the issues for the Parties, having consulted with them.

17.3. In the event that one of the Parties does not wish to settle any dispute which may arise in accordance with CEDR but instead wishes to commence proceedings in the English Courts, then the Parties irrevocably agree that the Courts of England will have exclusive jurisdiction to settle any outstanding dispute.

17.4. Notwithstanding the dispute settlement procedure described under Clause 17.1, either Party shall be entitled to seek a preliminary injunction in order to protect its rights.

17.5. This Agreement shall be governed by and construed in accordance with English law.

18. WAIVER OF BREACH

No waiver or forbearance by either Party in enforcing any of its rights under this Agreement shall prejudice or affect the ability of such Party to enforce such rights or any of its other rights at any time in the future. No waiver shall be effective unless in writing and signed by the other Parties. For the avoidance of doubt, it is agreed that a waiver of a right on one occasion shall not constitute a waiver of the same right in the future.

19. SEVERABILITY

19.1. In the event any portion of this Agreement shall be held illegal, void or ineffective, the remaining portions hereof shall remain in full force and effect.

19.2. If any of the terms or provisions of this Agreement are in conflict with any applicable statute or rule of law, then such terms or provisions shall be deemed inoperative to the extent that they may conflict therewith and shall be deemed to be modified to conform with such statute or rule of law.

19.3. In the event that the terms and conditions of this Agreement are materially altered as a result of Clauses 19.1 or 19.2 above, the Parties will renegotiate the terms and conditions of this Agreement in good faith to resolve any consequent inequities.

20. ENTIRE AGREEMENT

20.1. This Agreement, the Supply Agreement, the Quality Agreement, the Subscription Option Agreement and the Loan Agreement and any side letters entered into amending this Agreement or under the Territory Option Procedure constitute the entire agreement between the parties relating to the subject matter hereof and supersedes all previous agreements, negotiations and understandings. No terms or provisions of this Agreement shall be varied or modified by any prior or subsequent statement, conduct or act of either of the parties, except that the parties may amend this Agreement by written instruments specifically referring to and executed in the same manner as this Agreement.

20.2. In the event of any conflict between any of the provisions/terms of this Agreement, the Supply Agreement and the Quality Agreement, the terms of this Agreement shall take precedence over and to the exclusion of the terms of such other agreement that is in conflict with such terms.

21. NOTICES

21.1 Any communication to be given in connection with the matters contemplated by this Agreement shall except where expressly provided otherwise be in writing and shall either be sent by first class pre-paid post, delivered by hand or sent by fax. Delivery by courier shall be regarded as delivery by hand. Such communication shall be sent to the following addresses of the parties:

If to GW:		The Company Secretary
		GW Pharma Limited
		Porton Down Science Park,
		Salisbury,
		Wiltshire SP4 0JQ
		Fax No.: + 44 - 1980 557 111

If to Bayer:		Bayer AG
		Division Pharma
		International Cooperations and Licensing
		51368 Leverkusen
		Germany
		Fax No.: + 49 – 214 – 30 - 64840

copy to:

		Bayer AG
		Bayer HealthCare
		General Counsel
		51368 Leverkusen
		Germany
		Fax No.: + 49 – 214 – 30 – 82986

21.2. Any communication shall be deemed to have been served:

(a) if sent by first class pre-paid post to the addresses referred to above, at the expiration of two clear business days after the time of posting;

(b) if sent by fax to the above number, at the time of completion of transmission by the sender;

22. ACQUISITION OR MERGER OF BAYER PHARMACEUTICAL BUSINESS AND ASSIGNMENT

22.1. This Agreement and the licenses herein granted shall be binding upon and inure to the benefit of the successors in interest of the respective Parties. In the event that there is a

material change of ownership or control in the pharmaceutical business of Bayer or any of its Affiliates (“Acquisition”) then the following provisions shall apply:

(a) GW shall be entitled to request from the entity acquiring such ownership or control (“New Owner”) within thirty (30) days of the Acquisition a confirmation in writing that it is willing to assume in full the obligations and rights of Bayer with respect to this Agreement and the Supply Agreement. In the event that GW does not receive that confirmation within thirty (30) days from the date of such request this Agreement shall terminate upon written notice by GW.

(b) In the event that the New Owner does not achieve in any one of the next *** month periods after the Acquisition by the New Owner total sales levels throughout the Territory in relation to the Products of at least *** percent (***%) of those sales achieved by Bayer in the *** month period immediately prior to such Acquisition, each and every of the licences and rights granted under this Agreement shall become non-exclusive immediately upon written notice by GW to Bayer to this effect. In the event that a level of *** percent (***%) of those sales achieved by Bayer *** month period immediately prior to the Acquisition is not achieved by the New Owner in any one of the *** month periods after the Acquisition, this Agreement shall terminate upon written notice by GW to Bayer to this effect.

22.2. Neither this Agreement nor any interest hereunder shall be assignable by any Party without the written consent of the other provided, however, that either Party without obtaining the consent of the other Party may assign this Agreement or any part of its rights and obligations hereunder, or any patent owned by it, to any of its Affiliates or to any corporation with which such party may merge or consolidate, or to which it may transfer all or substantially all of its assets to which this Agreement relates, provided that such assignment be automatically reversed once the entity concerned ceases to be an Affiliate..

23. THIRD PARTY RIGHTS

No person who is not a Party to this Agreement shall have any rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any term of this Agreement provided that for the avoidance of doubt Clause 3 above shall prevail over this Clause 23.

24. COUNTERPARTS

24.1 This Agreement shall be executed in two counterparts, but shall not be effective until each party has executed at least one counterpart.

24.2 Each counterpart shall constitute an original of this Agreement, but all counterparts shall together constitute but one and the same instrument.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of		Signed for and on behalf of
BAYER AG		GW PHARMA LIMITED

Leverkusen, 20 May 2003		Salisbury, 20 May 2003


/s/ Dr. Dietrich Brocks		/s/ Justin Gover
Dr. Dietrich Brocks		Justin Gover
Head of International Cooperations and Licensing Europe		Managing Director


/s/ Dr. Dirk Ehle		/s/ David Kirk
Dr. Dirk Ehle		David Kirk
Law and Patents		Finance Director

APPENDIX 1

PRODUCTS

1. Sativex ® - Finished Products containing glass vials fitted with an actuator with a pump delivering 100 microlitre per spray containing 5.5 ml and/or 10 ml tetranabinex and nabidiolex extracts of Cannabis sativa L. equivalent to 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), per 100 microlitre actuation. The number of glass vials per carton as well as the to be marketed sizes of vials shall be agreed by the Country Commercialisation Committee.

The Product is intended for the Indications:

· for symptomatic relief in patients with multiple sclerosis;

· for relief of neuropathic pain;

· subject to a joint decision by the Parties, for relief of cancer pain.

Any additional Indication which might be approved by the corresponding Medicinal Product Regulatory Authority in a country of the Territory.

2. Glass vials fitted with an actuator with a pump delivering 100 microlitre per spray containing 5.5 ml and/or 10 ml Tetranabinex extract of Cannabis sativa L . equivalent to 2.7 mg delta-9-tetrahydrocannabinol (THC) per 100 microlitre actuation. To be defined further according to the draft SmPC prior to submission to the Medicinal Product Regulatory Authority.

APPENDIX 2

TERRITORY

Great Britain, Northern Ireland, the Channel Islands and the Isle of Man (“UK Territory”).

APPENDIX 3

LAUNCH CONDITIONS, UPFRONTS, MILESTONE EVENTS and PAYMENTS

PART A

The following payments are payable under the provisions of Clause 4 in relation to the following countries of the Territory:

A1. UK Territory

1. Upon entry by GW and Bayer into this Agreement payable on signature
£5 million

2. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product such sum as is equal to the sum of

£10 million

less any subscription monies paid by Bayer to GWP pursuant to Clause 3.2 of the Subscription Option Agreement as provided for by Clause 4.2 (ii)

3. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product for the indication of relief of one or more primary symptoms in patients with ***.
£***

4. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product in the indication of relief of ***.
£***

5. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product extract in the indication of the relief of ***.
£***

TOTAL FOR UK TERRITORY £25 million

A2. for each additional country within the Territory

1. Upon the fulfillment of the Launch Conditions for Product for the indication of relief of one or more primary symptoms in patients with MS.
£ million ***

2. Upon the fulfillment of the Launch Conditions for Product in the indication of relief of neuropathic pain.
£ million ***

3. Upon the fulfillment of the Launch Conditions for Product in the indication of the relief of cancer pain.
£ million ***

TOTAL FOR each additional country within the Territory £ million

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

PART B

The Parties shall agree within the Territory Option Period to Launch Conditions specific or non-specific to the countries within the EEA, Canada and Australia/ New Zealand. Such Launch Conditions shall be attached to Part B of Appendix 3 .

APPENDIX 4

GW IPR

INDEX - PATENTS AND PATENT APPLICATIONS

Section	Document Number	Document Description / Patent Number
***	***	***
***		***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***
***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

APPENDIX 5

TRADE MARK

Sativex®

UK: No: 2304388. Registered Date: 29/11/02

Europe: Not issued yet.

No: 002993384 Filing Date: 02/01/2003 Priority date: 04/07/2002).

15 countries which are: UK, Ireland, Finland, Sweden, Denmark, The Netherlands, Belgium, Germany, Luxembourg, Austria, France, Portugal, Spain, Italy and Greece.

International: Not Issued yet.

No: GB: 2304388 Filing date: 3/1/03 Priority Date: 4/7/02

20 countries which are: Japan, Australia, China, South Korea, Singapore, Switzerland, Norway, Bulgaria, Czech Republic, Estonia, Hungary, Liechtenstein, Lithuania, Latvia, Poland, Romania, Slovenia, Slovakia, Turkey and Yugoslavia.

Canada: Not issued yet.

No: 1163979 Date: Filing date: 06/01/03 Priority Date: 04/07/02)

Exhibit 10.2

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

AMENDMENT NUMBER 1

TO THE LICENSE AND DISTRIBUTION AGREEMENT

between GW PHARMA LIMITED (“GW”) having its registered office at Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ and BAYER HEALTHCARE AG, Division Pharma, having its registered office at Bayerwerk, 51368 Leverkusen, Germany (“Bayer”)

WHEREAS , Bayer AG and GW executed a License and Distribution Agreement as of the 20 th day of May 2003;

WHEREAS , Bayer AG transferred its entire healthcare business including all contractual rights and obligations to its 100% subsidiary Bayer HealthCare AG with effect of October 1, 2003, as permitted in accordance with Clause 22.2 of the License and Distribution Agreement;

WHEREAS , Bayer and GW wish to extend the period of the Territory Option Procedure for the EEA, Canada, Australia and New Zealand until December 31, 2003;

WHEREAS , Bayer decided to exercise its option under Clause 3.1 of the License and Distribution Agreement for Canada.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. Clause 3.1, second and third sentence, shall be rephrased as follows:

At any time between the Effective Date and 31 December 2003 Bayer may opt to add to the Territory certain further countries (from other countries in the EEA, Canada, Australia and New Zealand) and on the agreed respective Launch Conditions to be set out in Part B of Appendix 3 to this Agreement and otherwise subject to the terms of this Agreement, including without limitation Clause 3.2 below. Failure to agree any respective Launch Conditions by 31 December 2003 will result in GW being free to enter into a binding agreement with one or more Third Parties with respect to such countries unless the Parties shall have mutually agreed in writing to an extension to finalise such terms.

2. Bayer hereby exercises its option under Clause 3.1 of the License and Distribution Agreement and adds Canada to the Territory as of the date of this Amendment.

3. Appendix 3 , Part A and B, for Canada is completed in the form attached to this Amendment.

4. This Amendment shall be executed in two counterparts, but shall not be effective until each party has executed at least one counterpart. Each counterpart shall constitute an original of this Amendment, but all counterparts shall together constitute but one and the same instrument.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of		Signed for and on behalf of
BAYER HEALTHCARE AG		GW PHARMA LIMITED

Leverkusen, 4 th November 2003		Salisbury, 4 th November 2003

/s/ Dietrich Brocks		/s/ Justin Gover
Dr. Dietrich Brocks Head of International Cooperations and Licensing Europe		Justin Gover Managing Director

/s/ Alexander Bey		/s/ David Kirk
Dr. Alexander Bey Law and Patents		David Kirk Finance Director

APPENDIX 3 for Canada

LAUNCH CONDITIONS, MILESTONE EVENTS and PAYMENTS

PART A

The following payments are payable under the provisions of Clause 4 in relation to Canada:

1. Upon the fulfillment of the Launch Conditions for Product for the indication of relief of one primary symptom in patients with MS.
£1.8 million

2. Upon the fulfillment of the Launch Conditions for Product for the broader indication of relief of more than one primary symptom in patients with MS.
£1.2 million

For the avoidance of doubt, if an indication of relief of more than one primary symptom in patients with MS is obtained at one time, then both the payments in 1 and 2 above are payable.

3. Upon the fulfillment of the Launch Conditions for Product in an indication of relief of a *** .
£ ***

4. the fulfillment of the Launch Conditions for Product in the broader indication of *** .
£ ***

For the avoidance of doubt, if an indication of relief of neuropathic pain is obtained at one time, then both the payments in 3 and 4 above are payable.

5. Upon the fulfillment of the Launch Conditions for Product in the indication of the relief of cancer pain.
£0.75 million

6. GW may at its sole discretion elect to receive a further milestone payment of £ *** in the event that BAYER’s Net Sales in Canada in Commercial Year 2 exceed ***% of the Net Sales forecast as specified in Appendix 1 , Part B of the Supply Agreement as amended by Amendment Number 1. In the event that GW elects to receive this milestone payment, the Supply Price in respect of incrementel Net Sales above *** percent (***%) of the Net Sales forecast shall be reduced to *** percent (***%) of the Net Selling Price. Such reduction in the Supply Price shall be effective retroactively for Commercial Year 2 and for subsequent Commercial Years.

TOTAL FOR Canada £ ***

PART B

Launch Conditions for Canada:

Approval by the Medicinal Products Regulatory Authority in Canada

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.3

AMENDMENT NUMBER 2

TO THE LICENSE AND DISTRIBUTION AGREEMENT

WHEREAS , Bayer and GW executed a License and Distribution Agreement as of the 20 th day of May 2003, as amended by Amendment Number 1 dated November 3, 2003;

WHEREAS , Bayer and GW wish to extend the period of the Territory Option Procedure for the EEA, Australia and New Zealand;

WHEREAS , Bayer agrees to advise GW in certain regulatory and scientific issues.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. “First Ready Date” shall mean the first business day following a thirty (30) day period after grant of the first Marketing Authorisation for the Product in the UK Territory.

2. “Second Ready Date” shall mean the first business day following a three (3) month period after grant of the first Marketing Authorisation for the Product in the UK Territory.

3. Until the Second Ready Date, Bayer shall provide — free of charge and upon request of GW — advice to GW relating to certain regulatory and scientific issues concerning the acceptability of the regulatory dossiers for Products in the Territory and in the further countries that may be added to the Territory in accordance with Clause 3.1 of the Agreement

4. Clause 3.1, second and third sentence, shall be rephrased as follows:

At any time between the Effective Date and the First Ready Date, Bayer may opt to add Australia and New Zealand to the Territory and on the agreed respective Launch Conditions to be set out in Part B of Appendix 3 to this Agreement and otherwise subject to the terms of this Agreement, including without limitation Clause 3.2 below. At any time between the Effective D ate and t he Second Ready D ate, Bayer may opt to add to the Territory certain further countries in the EEA and on the agreed respective Launch Conditions to be set out in Part B of Appendix 3 to this Agreement and otherwise subject to the terms of this Agreement, including without limitation Clause 3.2 below. Failure to agree any respective Launch Conditions by the First Ready Date in respect of Australia and New Zealand and by the Second Ready Date in respect of countries in the EEA will result in GW being free to enter into a binding agreement with one or more Third Parties with respect to such countries unless the Parties shall have mutually agreed in writing to an extension to finalise such terms.

5. This Amendment shall be executed in two counterparts, but shall not be effective until each party has executed at least one counterpart. Each counterpart shall constitute an original of this Amendment, but all counterparts shall together constitute but one and the same instrument.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of	Signed for and on behalf of

BAYER HEALTHCARE AG	GW PHARMA LIMITED

Leverkusen, 14 January 2004	Salisbury, 14 January 2004


/s/ Dietrich Brocks		/s/ Justin Gover
Dr. Dietrich Brocks		Justin Gover
Head of International Cooperations		Managing Director
and Licensing Europe


/s/ Dirk Ehle		/s/ David Kirk
Dr. Dirk Ehle		David Kirk
Law and Patents		Finance Director

Exhibit 10.4

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

AMENDMENT NUMBER 3

TO THE LICENSE AND DISTRIBUTION AGREEMENT

between GW PHARMA LIMITED (“GW”) having its registered office at Porton Down Science Park, Salisbury, Wiltshire SP4 OJQ and BAYER HEALTHCARE AG, Division Pharma, having its registered office at Bayerwerk, 51368 Leverkusen, Germany (“Bayer”)

WHEREAS , Bayer and GW executed a License and Distribution Agreement as of the 20th day of May 2003, as amended by Amendments Number 1 and 2;

WHEREAS , Bayer and GW now wish to complete Appendices 5 and 6 for the Canadian Territory.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. Appendix 5 , Part B, and Appendix 6 , Part B, are completed for the Canadian Territory in the form attached to this Amendment.

2. This Amendment shall be executed in two counterparts, but shall not be effective until each party has executed at least one counterpart. Each counterpart shall constitute an original of this Amendment, but all counterparts shall together constitute but one and the same instrument.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of		Signed for and on behalf of

BAYER HEALTHCARE AG		GW PHARMA LIMITED

Leverkusen, February 22, 2005		Salisbury, March 1 st 2005

/s/ Dr. Horst Harenberg		/s/ Justin Gover
Dr. Horst Harenberg Head of International Cooperations and Licensing Europe		Justin Gover Managing Director


/s/ Dr. Dirk Ehle		/s/ David Kirk
Dr. Dirk Ehle Law and Patents		David Kirk Finance Director

APPENDIX 5

ORDERS FOR PRODUCTS

The following provisions apply under the provisions of Clause 3 in relation to the following countries of the Territory:

PART B

Canadian Territory

1. Bayer Inc. through Bayer shall provide to GW within the first five working days of each month with a forecast APPENDIX of demand for the Product(s) for at least the following *** (***) months (“Forecast APPENDIX”). The forecast APPENDIX shall be updated monthly. In addition and subject to Clauses 2 - 7 below, Bayer shall GW during the Fourth (4th) quarter of each calendar year with an annual forecast for the following calendar year which shall serve as a basis for the ordering system and shall not contain binding orders but quantities corresponding to the first twelve (12) months of the Forecast APPENDIX. Against this annual forecast Bayer will formally call off the respective quantities.

2. Based on the *** month projected forecast, Bayer shall provide GW the Purchase Order Requirements which may represent half or full batches of requirements, notwithstanding that the first *** (***) months is the Firm Order Period. A purchase order will be forwarded by Bayer to GW for each firm requirement. Bayer Inc. will generate and provide Bayer one (1) purchase order projecting the total yearly purchase based on the forecast. GW will be provided with Bayer and Bayer Inc. purchase order and will ensure that all shipments (packaging slip) reference the Bayer Inc and Bayer purchase order, article code, batch number, weight and volume.

3. The quantities of the Products detailed in the first *** (***) months of each Forecast APPENDIX (“Firm Order Period”) shall (to the extent set out in Appendix 5 ) constitute a binding commitment on Bayer in relation to each Country to purchase such quantities of the Products from GW on the terms and conditions of this Agreement (“Firm Order”). With respect to each Bayer Inc, Bayer shall issue to GW a Firm Order for the quantity of the Products ordered for the Firm Order Period not later than *** (***) weeks prior to the Delivery date specified therein. The Firm Order shall specify the arrangements for Delivery of the Products. The Parties agree that all Firm Orders for the Products placed by Bayer with GW under this Agreement shall be supplied on the terms of this Agreement.

4. In determining Firm Order quantities for Canada, Bayer shall take account of Manufacturing batch sizes, such that Bayer must accept a half or full batches per order and the orders are fulfilled orders, actual quantities of Products Manufactured which are within a margin of *** (***) percent of the Firm Order quantity. In the event GW supplies quantities in an aggregated shortfall of more than thirty (30) percent, then GW shall discuss with Bayer Inc and AG whether they are obliged to make up such shortfall quantities as early as possible. The Manufacturing of a full batch size for the Products shall be *** ( *** ) vials ( *** ) and half a batch quantity will represent *** ( *** ) vials ( *** ). Any variance to the order quantity shall be notified by GW to Bayer Inc. & Bayer in writing.

5. The volumes detailed in the *** (***) months after the Firm Order Period of the Forecast APPENDIX (the “Semi-Firm Order Period”, being months ***) shall represent a semi-firm

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

order for each Canada, meaning that Bayer shall be obliged to order and purchase at least ***% of the initial forecast for any month *** forecast. For the avoidance of doubt the initial forecast for any month 8 forecast may not vary by more than thirty percent (+1-) by the time that forecast becomes a Firm Order. GW shall hold sufficient stocks of intermediates to meet the forecast requirements during the Firm Order Period and up to *** percent (***%) of the forecast requirements detailed in the Semi-firm Order Period. Both Parties shall conduct their businesses so as to minimize any stock write-offs. Bayer Inc. may ask GW for additional quantities to be manufactured and delivered by GW. GW shall use its reasonable efforts to comply with Bayer Inc. additional demand. In any case GW shall give notice to Bayer Inc and Bayer within two (2) business days if additional quantity will be required.

6. GW shall respond to each Firm Order received from Bayer within three (3) business days of receipt. The response shall include confirmation of the Delivery dates and quantity as set out in the Firm Order. In the event that discussion is required regarding the timings of production and Delivery then the relevant planning personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Forecast APPENDIX within four (4) business days of receipt by GW of the original Forecast APPENDIX except during the period 20 th December to 6 th January in each year when the periods of three (3) or four (4) business days referred to herein shall be replaced by eight (8) business days in each case.

7. It is understood that volumes detailed in relation to the remaining *** (***) months of the Forecast APPENDIX after the Firm Order Period and the Semi-Order Period constitute an estimate of the future Product requirement of Bayer Inc. and its Affiliates for each Country within the Territory and do not comprise any minimum purchase requirement or any binding commitment by Bayer or its affiliates to purchase such volume of the Products.

8. Binding orders subject to approval in the Territory for Bayer Inc. requirements of Launch Stocks shall be provided by Bayer Inc. and Bayer within ten (10) business days of the Effective Date. The delivery date shall be agreed by the UK Country Commercialization Committee. Bayer shall notify GW in writing with a copy to Bayer Inc. of the Delivery date for the Launch Stocks at least *** (***) weeks before due delivery date specified for Launch.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

APPENDIX 6

DELIVERY OF PRODUCTS

The following provisions apply under the provisions of Clause 4 in relation to the following countries of the Territory:

PART B

Canadian Territory

1. GW shall ensure that the Products manufactured hereunder are delivered in Canada in accordance with the provisions of this Agreement. The costs of Delivery of the Products from GW or the premises of its Authorized Contractor as appropriate to Bayer’s nominated distribution centre or other nominated location in the Canada in question shall be borne by Bayer Inc.

2. With respect to Launch Stocks and for all the Products Manufactured with a maximum permitted shelf life of *** (***) months, there shall be a minimum of *** (***) months’ shelf life remaining on the Products at the date of Delivery requested by Bayer Inc. on each Bayer Inc. order. In the case of any of the Products with less than *** (***) months’ shelf-life, the Products shall be returned to GW at GW’s reasonable cost and replaced with Product having the required shelf-life at no cost to Bayer, unless Bayer Inc. and Bayer accepts these products for sale.

3. In the event that the shelf-life permitted by a Governmental Authority applicable to a Country is extended beyond *** (***) months or to any other period the Parties shall negotiate in good faith and agree in writing the revised shelf life remaining on the Products upon Delivery to Bayer Inc. and the date upon which the first Delivery shall be made of the Products with such extended shelf-life PROVIDED ALWAYS THAT at the date of Delivery requested by Bayer Inc. on each Bayer and Bayer Inc. order the shelf life remaining on the Products at the date of Delivery shall be at least *** percent (*** %) of the total shelf life available for the Products or *** (***) months. In the event that the said Governmental Authority approves an extension to the shelf-life beyond *** (***) months or approval for the *** size, the Parties shall develop an implementation and transition to plan to minimize write-off costs for the *** vial and to ensure minimum disruption to patients and any write-offs costs shall be shared equally. Bayer Inc. shall undertake to launch the *** vial for the Products, upon agreement as to the transitional arrangements, and subject to approval by the Governmental Authority and availability of stocks of the Products from GW to satisfy Bayer Inc. Firm Order requirements.

4. In the event of a delay caused by the acts or omissions of a Governmental Authority in a Country resulting in a delayed Launch beyond the Launch date to be agreed between the parties in writing and Bayer Inc. is not able to sell such part or all of the Launch Stocks, the Parties shall equally share GW’s write-off costs of the destruction of any Launch Stocks of the Products calculated in accordance with Appendix 5 . GW shall provide replacement stocks in respect of any destroyed Launch Stocks as soon as is reasonably practicable. If GW has invoiced Bayer with any proportion of such destroyed Launch Stocks GW shall credit Bayer with the invoiced value of that proportion of the Launch Stocks.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

5. In the event that GW fails to deliver in response to the Firm Orders for the Products for a Country on the specified Delivery date by reason of delay, GW shall provide a revised Delivery date. In the event that Delivery is more than ten (10) business days later than the original specified Delivery date, GW shall provide to Bayer and Bayer INC. an action plan to achieve within twenty (20) business days from the original delivery date and Bayer Inc. is able to demonstrate that it has thereby suffered a material stock shortage of the Products at its nominated distribution centre ***

:

***		***
***		***
***		***
***		***

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.5

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

AMENDMENT NUMBER 4

TO THE LICENSE AND DISTRIBUTION AGREEMENT

WHEREAS , Bayer and GW executed a License and Distribution Agreement as of the 20 th day of May 2003, as amended by Amendments Number 1, 2 and 3;

WHEREAS , Bayer and GW wish to amend certain clauses under the License and Distribution Agreement on the terms set out in this Amendment Number 4;

WHEREAS , Bayer and GW agreed to terminate the Subscription Option Agreement dated the 20th day of May 2003 on the terms set out in this Amendment Number 4;

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. The definition of the “First Ready Date”, as established by Amendment Number 2 to the License and Distribution Agreement, shall be revised as follows:

“First Ready Date” shall mean the earlier of (i) the sixth business day after grant of the first Marketing Authorisation for the Product in the UK Territory and (ii) 16 September 2005.

2. The definition of the “Second Ready Date”, as established by Amendment Number 2 to the License and Distribution Agreement, shall be revised as follows:

“Second Ready Date” shall mean 16 September 2005.

3. The existing Clause 3.1 of the License and Distribution Agreement shall be deleted in its entirety and replaced with the following:

“Subject to Clause 3.3, at any time between the Effective Date and the First Ready Date, Bayer may opt to add Australia and New Zealand to the Territory and on the agreed respective Launch Conditions to be set out in Part B of Appendix 3 to this Agreement and otherwise subject to the terms of this Agreement (including without limitation Clause 3.2 below). Subject to Clause 3.3, at any time between the Effective Date and the Second Ready Date, Bayer may opt to add to the Territory certain further countries in the EEA and the United States of America, and on the agreed respective Launch Conditions to be set out in Part B of Appendix 3 to this Agreement and otherwise subject to the terms of this Agreement (including without limitation Clause 3.2 below) and, if applicable, subject also to agreement between Bayer and GW in relation to any revisions to this Agreement required and/or appropriate under applicable law and regulation by reason of the proposed addition of a country or countries to the Territory,. Failure to agree any respective Launch Conditions by the First Ready Date in respect of Australia and New Zealand and by the Second Ready Date in respect of countries in the EEA and the United States of America will result in GW being free to enter into a binding agreement with one or more Third Parties with respect to such countries unless the Parties shall have mutually agreed in writing to an extension of the period within which to finalise such terms.”

4. A new Clause 3.3 shall be included in the following terms:

“Bayer undertakes and agrees to provide GW by no later than 30 June 2005 written confirmation of those countries referred to in Clause 3.1 above (which it is entitled to add to the Territory pursuant to Clause 3.1) which it intends to extend to the Territory. Any countries not expressly referred to in such written confirmation shall be deemed excluded from the Territory extension procedure contained in Clause 3.1 “

5. Appendix 3 , Part A.1 (UK Territory) shall be replaced by Appendix 1, Part A.1 (UK Territory), as attached to this Amendment.

6. Appendix 3 , Part A.2 (Canada Territory), as attached to Amendment Number 1 to the License and Distribution Agreement, shall be replaced by Appendix 1, Part A.2 (Canada Territory), as attached to this Amendment.

7. This Amendment Number 4 shall be executed in two counterparts, but shall not be effective until each party has executed at least one counterpart. Each counterpart shall constitute an original of this Amendment, but all counterparts shall together constitute but one and the same instrument.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Amendment Number 4 as of the date first written above.

Signed for and on behalf of BAYER HEALTHCARE AG Leverkusen, May 9, 2005		Signed for and on behalf of GW PHARMA LIMITED Salisbury, May 10 2005


/s/ Dr. Horst Harenberg		/s/ Justin Gover
Dr. Horst Harenberg Head of International Cooperations and Licensing Europe		Justin Gover Managing Director


/s/ Dr. Dirk Ehle	/s/ David Kirk
Dr. Dirk Ehle Law and Patents	David Kirk Finance Director

APPENDIX 3 for the UK Territory

LAUNCH CONDITIONS, UPFRONTS, MILESTONE EVENTS and PAYMENTS

PART A

The following payments are payable under the provisions of Clause 4 in relation to the following countries of the Territory:

A1. UK Territory

1. Upon entry by GW and Bayer into this Agreement payable on signature £5 million (payment already executed)

2. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product such sum as is equal to the sum of
£6 million

3. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product for the indication of relief of one or more primary symptoms in patients with MS. £4 million

4. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product in the indication of *** .
£***

5. Upon the grant of a Marketing Authorisation by the UK MHRA (or successor body) for Product extract in the indication of *** .
£***

6. Subject to paragraph 9, in the event that Bayer’s Net Sales in the UK Territory in Commercial Year 1 exceed the Net Sales forecast as specified in Appendix 1 , Part A of the Supply Agreement (as amended by Amendment Number 2), for each ***% (*** percent) in excess of the Net Sales forecast an amount of £*** million, up to a maximum (which would be achieved in the event that BAYER’s Net Sales forecasts are exceeded by ***%) of £***

7. Subject to paragraph 9, in the event that Bayer’s Net Sales in the UK Territory in Commercial Year 2 exceed the Net Sales forecast as specified in Appendix 1 , Part A of the Supply Agreement (as amended by Amendment Number 2), for each *** % (*** percent) in excess of the Net Sales forecast an amount of £***million, up to a maximum (which would be achieved in the event that BAYER’s sales forecasts are exceeded by ***%) of £***

8. Subject to paragraph 9, in the event that Bayer’s Net Sales in the UK Territory in Commercial Year 3 exceed the Net Sales forecast as specified in Appendix 1, Part A of the Supply Agreement (as amended by Amendment Number 2), for each *** % (*** percent) in excess of the Net Sales forecast an amount of £*** million, up to a maximum (which would be achieved in the event that Bayer’s sales forecasts are exceeded by ***%) of £***

9. With respect to the payments referred to in paragraphs 6, 7 and 8 above, if Bayer’s Net Sales in the 4th quarter of each of the first 3 Commercial Years fall below the average of Bayer’s Net Sales in the preceding two quarters, then that year’s additional milestone payment shall be deemed to be £*** and shall become immediately payable.

10. Additionally, at the end of the first 3 Commercial Years, Bayer’s actual cumulative Net Sales shall be compared to Bayer’s total Net Sales forecast for this 3 year period as

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

contained in Appendix 1, Part A of the Supply Agreement (as amended by Amendment

Number 2). For each ***% by which Bayer’s actual cumulative Net Sales exceed Bayer’s total Net Sales forecast, £*** shall be payable, provided that any sums due and payable hereunder shall be reduced by an amount equal to any payments made pursuant to paragraphs 6, 7, 8 and 9 above).

For the avoidance of doubt, GW’s maximum entitlement under paragraphs 6, 7, 8, 9 and 10 shall not exceed £***, which would be achieved in the event that Bayer’s 3 year cumulative Net Sales forecasts are exceeded by ***%.

11. For the avoidance of doubt, Bayer undertakes and agrees that it will or will procure the incurring of the sales and marketing expenditure as presented to Bayer’s Commercialisation Committee prior to the commencement of each of the first 3 Commercial Years irrespective of the additional milestone payment provisions contained in paragraphs 6, 7, 8, 9 and 10 above. For the further avoidance of doubt, Bayer undertakes and agrees that the additional milestone payment provisions contained in paragraphs 6, 7, 8, 9 and 10 above shall have no adverse impact upon the UK Bayer personnel bonus payment structures or payments.

TOTAL FOR UK TERRITORY

£***million

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

APPENDIX 3 for the Canada Territory

LAUNCH CONDITIONS, MILESTONE EVENTS and PAYMENTS

PART A

The following payments are payable under the provisions of Clause 4 in relation to Canada:

A.2 Canada Territory

1. Upon the fulfillment of the Launch Conditions for Product for the indication of relief of one primary symptom in patients with MS.
£1.8 million

2. Upon the fulfillment of the Launch Conditions for Product for the broader indication of relief of more than one primary symptom in patients with MS.
£1.2 million.

For the avoidance of doubt, if an indication of relief of more than one primary symptom in patients with MS is obtained at one time, then both the payments in 1 and 2 above are payable.

3. Upon the fulfillment of the Launch Conditions for Product in an indication of relief of a form of *** .
£***

4. Upon the fulfillment of the Launch Conditions for Product in the *** .
£***.

For the avoidance of doubt, if an indication of relief of *** is obtained at one time, then both the payments in 3 and 4 above are payable.

5. Upon the fulfillment of the Launch Conditions for Product in the indication of *** .
£***

6. GW may at its sole discretion elect to receive a further milestone payment of £*** million in the event that BAYER’s Net Sales in Canada in Commercial Year 2 exceed ***% of the Net Sales forecast as specified in Appendix 1 , Part B of the Supply Agreement as amended by Amendment Number 1. In the event that GW elects to receive this milestone payment, the Supply Price in respect of incremental Net Sales above *** percent (***%) of the Net Sales forecast shall be reduced to *** percent (***%) of the Net Selling Price. Such reduction in the Supply Price shall be effective retroactively for Commercial Year 2 and for subsequent Commercial Years.

7. Upon signature of this Amendment No. 4 and in consideration for the first approval of Sativex in Canada and the inclusion of the United States of America in Clause 3.1. of the Licence and Distribution Agreement.
£1.0 million.

Total for Canada

£ *** million

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.6

Amendment # 5

to the License and Distribution Agreement by and between Bayer Schering Pharma AG (formerly “Bayer AG, Bayer HealthCare, Division Pharma”) and GW Pharma Limited dated May 20, 2003 — hereinafter referred to as “Distribution Agreement” —

between Bayer Schering Pharma AG
Muellerstrasse 178
D-13353 Berlin
Germany
- hereinafter referred to as “BAYER” -

and GW Pharma Limited
Porton Down Science Park
Salisbury, Wiltshire SP4 0JQ
- hereinafter referred to as “GW” –

WHEREAS, Bayer AG has transferred its Division Pharma to Bayer HealthCare AG following the execution of the Distribution Agreement in 2003;

WHEREAS, Bayer HealthCare AG merged with BAYER effective as of December 30, 2008, with BAYER as the universal successor so that BAYER is the new contracting party to the Distribution Agreement;

WHEREAS, BAYER and GW have entered into the Distribution Agreement by which BAYER was appointed as GW’s exclusive distributor to sell, offer for sale, market, promote and distribute the Products (as defined in the Distribution Agreement) in the Territory (as defined in the Distribution Agreement);

WHEREAS, BAYER and GW intend to amend the Distribution Agreement in respect of the term.

NOW, THEREFORE, the PARTIES agree to the following:

1. Unless otherwise defined in this Amendment # 5 all words written in capital letters shall bear the meaning as defined in the Distribution Agreement.

2. Section 12.1 sentence 1 part 1 of the Distribution Agreement shall be deleted and replaced by the following wording:

“This Agreement shall continue until the expiry of fifteen (15) years from the date on which the Marketing Authorisation is granted for the UK Territory (“Initial Term”), ...”.

3. This Amendment # 5 shall form an integral part of the Distribution Agreement and shall be regarded as incorporated into the Distribution Agreement in every respect. All other terms and conditions of the Distribution Agreement shall remain in force unchanged.

4. This Amendment # 5 shall take effect upon its execution.

5. In all other respects, the terms of the Distribution Agreement shall remain unchanged.

This Amendment # 5 has been made in duplicate and signed by the PARTIES hereto.

Bayer Schering Pharma AG

/s/ Dr. Berthold Hinzen 5/3/2010		/s/ i.v. Klaus Deimel 5/3/2010
Dr. Berthold Hinzen		Klaus Deimel
Head Global Licensing General		Head Business Development Region
Medicine		Europe


GW Pharma Limited

/s/ Justin Gover		/s/ David Kirk
Name:	Justin Gover	Name:	David Kirk
Title:	Managing Director	Title:	Finance Director
Date:	10 March 2010	Date:	10 March 2010

Exhibit 10.7

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

BAYER AG

and

GW PHARMA LTD

SUPPLY AGREEMENT

CONTENTS

1. DEFINITIONS	3
2. SUPPLIER’S OBLIGATIONS	6
3. ORDERS FOR PRODUCTS	6
4. DELIVERY OF PRODUCTS	7
5. PASSING OF PROPERTY AND RISK IN PRODUCT	7
6. PRICE OF PRODUCTS	7
7. INVOICE AND PAYMENT	7
8. FAILURE TO SUPPLY; SECURITY OF SUPPLY	8
9. QUALITY OF PRODUCTS	11
10. SUPPLY AND STORAGE OF MATERIALS AND PRODUCTS	12
11. MARKETING AUTHORISATION	13
12. MANUFACTURE OF PRODUCTS	13
13. LABELLING AND ARTWORK	13
14. HAZARDS	14
15. WARRANTIES AND INDEMNITY	14
16. DURATION AND TERMINATION	14
17. CONSEQUENCES OF TERMINATION	15
18. AUTHORISED CONTRACTORS	16
19. REFERENCE	16
APPENDIX 1 - THE SUPPLY PRICES	18
APPENDIX 2 - DRAFT SPECIFICATIONS OF PRODUCTS	20
APPENDIX 3 - QUALITY AGREEMENT	21
APPENDIX 4 - POWER OF ATTORNEY	22
APPENDIX 5 - ORDERS FOR PRODUCTS	23
APPENDIX 6 - DELIVERY OF PRODUCTS	25

SUPPLY AGREEMENT

THIS SUPPLY AGREEMENT (“Agreement”) is made the 20 th day of May 2003 between BAYER AG, Bayer HealthCare, Division Pharma, having its registered office at Bayerwerk, 51368 Leverkusen, Germany (“Bayer”) and GW PHARMA LIMITED having its registered office at Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ (“GW”).

WHEREAS , Bayer and its Affiliates have experience in the market development, marketing, promotion and sale of pharmaceutical products and desires to obtain a licence to the rights to sell and distribute such cannabinoid products in the Territory and GW is willing to grant to Bayer such rights;

WHEREAS , GW and Bayer entered into a License and Distribution Agreement, a Loan Agreement and a Subscription Option Agreement as of the date hereof; and

WHEREAS , Bayer wishes to purchase the Products manufactured by GW for sale and distribution in the Territory and GW wishes to supply such Products to Bayer.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. DEFINITIONS

1.1. “Affiliate(s)” shall have the meaning defined in the License and Distribution Agreement.

1.2. “Agreement” shall mean this supply agreement together with all its appendices including without limitation the Quality Agreement (the “Appendi(x)(ces)”).

1.3. “Authorised Contractors” shall mean ***; *** and ***.

1.4. “Bayer Sales” shall mean the sales of units of Product ex warehouse reported by Bayer in each Country.

1.5. “Commercial Year” shall mean the twelve (12) month period in each Country beginning with the month following the Launch date and each subsequent twelve (12) month period.

1.6. “Contract Governance Committee” shall have the meaning defined in the License and Distribution Agreement.

1.7. “Controlled Drugs Authority” shall have the meaning defined in the License and Distribution Agreement.

1.8. “Country” shall mean each country within the Territory.

1.9. “Country Commercialisation Committee(s)” shall have the meaning defined in the License and Distribution Agreement.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.10. “Delivery” shall mean the Products either available for collection by Bayer or its appointed carrier for transporting to the Bayer nominated warehouse; or available for delivery by GW or its appointed carrier to the Bayer nominated warehouse as notified by Bayer and “Deliver” and “Delivered” shall be construed accordingly.

1.11. “Effective Date” shall mean the date upon which this Agreement is effective and shall be the date of this Agreement first above written.

1.12. “Estimated Supply Prices” shall mean the List Prices for the Products in a Country less the wholesaler discount agreed in writing from time to time between the Parties based on the agreed standard prevailing wholesaler discount in the Country in question multiplied by the relevant Supply Price percentage as stated in Appendix 1 to this Agreement.

1.13. “Good Manufacturing Practice” or “GMP” shall mean the regulatory standards and principles and guidelines of Good Manufacturing Practice as in force from time to time relating to the production of medicinal products established by the applicable Governmental Authority applicable anywhere in the Territory including, without limitation, the Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use published by the European Commission, as the same may be amended from time to time. GMP includes Good Distribution Practice (“GDP”) as defined by Directive 2001/83/EC for the purposes of this Agreement.

1.14. “Governmental Authority” shall have the meaning defined in the License and Distribution Agreement.

1.15. “Gross Sales” shall mean the gross amounts invoiced by Bayer in respect of the sales of the Products in the Territory under this Agreement by Bayer or its Affiliates to third parties at an arm’s length open market price.

1.16. “IMS” shall mean Intercontinentall Medical Statistics or any other agreed source.

1.17. “IMS Sales” shall mean the total IMS reported sales of Product in each Country.

1.18. “Indication” shall have the meaning defined in the License and Distribution Agreement.

1.19. “Intermediates” shall mean the raw materials and components used in the three stages of Manufacture of the Products.

1.20. “Laboratory” shall mean the independent testing laboratory agreed between the parties for the testing of disputed shipments pursuant to Clause 9.

1.21. “Launch Conditions” shall have the meaning defined in the License and Distribution Agreement.

1.22. “Latent Defect” shall mean a defect in a Product existing at the time of receipt by Bayer which is not discovered by visual inspection and which is not attributable to the storage of a Product by Bayer.

1.23. “Launch” shall have the meaning specified in the License and Distribution Agreement.

1.24. “Launch Stocks” shall mean those stocks of the Products Manufactured by GW or Authorised Contractors on its behalf as specifically ordered for Launch by Bayer.

1.25. “Licence and Distribution Agreement” shall mean the agreement of even date for the licensing and distribution of the rights to the Products.

1.26. “Licence to Manufacture” shall mean the conditional rights to manufacture granted to Bayer under Clause 2.4 of the Licence and Distribution Agreement and more particularly described in Clause 8.2 of this Agreement.

1.27. “List Price(s)” shall mean with respect to the UK Territory the prices that pharmacists are paid for the Products by the Governmental Authorities in a Country or the nearest equivalent price in other Countries of the Territory.

1.28. “Manufacture” shall mean the planning, purchasing, cultivating, extracting, manufacture, processing, compounding, storage, filling, packaging, labelling, leafleting, testing, sample retention, stability testing, release, QP certification and despatch of the Products (or procurement of the same) and “Manufactured” and “Manufacturing” shall be construed accordingly.

1.29. “Manufacturing Know-How” shall mean the technical information and know-how in the possession or under the control of GW relating to the Manufacture and formulation of the Products.

1.30. “Manufacturing Licence” shall mean all licences necessary for or in connection with the Manufacture of the Products at the Manufacturing Site(s).

1.31. “Manufacturing Site” shall mean the manufacturing facility of GW or such other manufacturing facility of GW or of any Authorised Contractor appointed by GW under this Agreement applicable to the Manufacture of the Products.

1.32. “Marketing Authorisation(s)” shall have the meaning defined in the License and Distribution Agreement.

1.33. “Net Sales” shall have the meaning defined in the License and Distribution Agreement.

1.34. “Net Selling Price” shall mean Net Sales per unit of Product.

1.35. “Out of Stock Situation” shall have the meaning specified in Clause 8.2.4.

1.36. “Party(ies)” shall have the meaning defined in the License and Distribution Agreement.

1.37. “Person Day” shall mean eight (8) hours work by a representative of GW qualified to assist in transfer of the Manufacturing Know-How.

1.38. “Products” shall have the meaning defined in the License and Distribution Agreement.

1.39. “Qualified Person” (or “QP”) shall mean the person responsible for releasing or certifying each batch of the Products for sale.

1.40. “Quality Agreement” shall mean the agreement to be entered into between GW and the Authorised Contractors and the agreement to be entered into between GW and Bayer as required by the Governmental Authority relating to the Manufacture, storage or distribution of the Products to be attached hereto as Appendix 3 in accordance with the requirements of Council Directive 2001/83/EEC.

1.41. “Specifications” shall mean the specifications applicable to the Products in accordance with a Marketing Authorisation, drafts of which are attached as Appendix 2 to this Agreement.

1.42. “Supply Price(s)” shall mean the prices of the Products set out in Appendix 1 to this Agreement.

1.43. “Technical Manager(s)” shall mean the person nominated in writing by Bayer and the person nominated in writing by GW who will be responsible for technical matters relating to the implementation of this Agreement (and such other persons as may from time to time be substituted by either Party for such persons).

1.44. “Territory” shall have the meaning defined in the License and Distribution Agreement.

1.45. “Trade Mark” shall mean such trade mark as Bayer may from time to time request GW to affix during Manufacture of the Products as set out in Appendix 5 of the License and Distribution Agreement.

1.46. “UK Territory” shall have the meaning defined in the License and Distribution Agreement.

1.47. “Wholesale Dealer’s Licence” shall mean the consent, licence or approval granted by a Governmental Authority in a Country required in order to supply medicinal products on a wholesale basis.

1.48. In this Agreement unless it is inconsistent with the context a reference to a statutory provision includes a reference to:

(i) a statutory amendment, modification, substitution, consolidation or re-enactment (whether before or after the date of this Agreement);

(ii) statutory instruments or subordinate legislation or orders made under the statutory provision; and

(iii) statutory provisions of which the statutory provision is an amendment, modification, substitution, consolidation or re-enactment.

Unless the context of this Agreement otherwise requires,

(i) words of one gender includes the other gender;

(ii) words using the singular or plural number also include the plural or singular number respectively;

(iii) the terms “hereof”, “herein”, “hereby” and derivative or similar words refer to this entire Agreement; and

(iv) the terms “Clause” and “Appendix” refer to the specified Clause and Appendix of this Agreement.

2. SUPPLIER’S OBLIGATIONS

2.1. In accordance with the terms of this Agreement and subject to Clause 16.2, GW shall Manufacture Bayer’s requirements for the Products as ordered from time to time by Bayer in accordance with Appendix 5 except in circumstances where GW is unable to supply Bayer with its requirements for the Products in accordance with this Agreement in which case the provisions of Clause 8.2 below shall apply.

2.2. GW shall Manufacture the Products at the Manufacturing Site(s) in accordance with Good Manufacturing Practice, the Specifications, the Manufacturing Licence, approvals of a Governmental Authority and all laws and regulations relevant to the Manufacture of the Products. Without prejudice to the foregoing, GW shall not change any Manufacturing Site in which the Products are Manufactured, or the Intermediates, process or plant used in the Manufacture of the Products without first notifying Bayer in advance in writing and obtaining Bayer’s prior written consent which shall not be unreasonably withheld. In the event that Bayer responds to such written notice with questions or concerns, the Parties shall promptly meet and discuss any alternative course of action. Bayer acknowledges that GW, as the holder of the Marketing Authorisation, may be required to make any such changes without delay particularly if such changes relate to regulatory requirements or safety concerns.

2.3. Any changes in the Specifications for the Products must be agreed in writing by both Parties. Consent from Bayer shall not be unreasonably withheld or delayed.

3. ORDERS FOR PRODUCTS

3.1. Subject to Clause 16.2, Bayer shall purchase its entire requirement of Product from GW.

3.2. The provisions relating to orders for Products applicable to the UK Territory are set out in Appendix 5.A . The Parties undertake to negotiate in good faith as part of the Launch Conditions adjustments required to such provisions for countries added to the Territory under the Territory Option Procedure set out in Clause 3 of the License and Distribution Agreement. Such adjusted provisions shall be attached as Appendix 5.B etc. for each Country concerned.

4. DELIVERY OF PRODUCTS

The provisions relating to Delivery of Products applicable to the UK Territory are set out in Appendix 6.A . The Parties undertake to negotiate in good faith as part of the Launch Conditions adjustments required to such provisions for countries added to the Territory under the Territory Option Procedure set out in Clause 3 of the License and Distribution Agreement. Such adjusted provisions shall be attached as Appendix 6.B. etc. for each Country concerned.

5. PASSING OF PROPERTY AND RISK IN PRODUCTS

5.1. The property and risk in the Products shall remain with GW until Delivery at which point they shall pass to Bayer.

5.2. Neither payment by nor passage of property or risk in the Products to Bayer shall be deemed to constitute acceptance of the Products, with respect to which the provisions of Clause 9.4 below shall apply.

6. PRICE OF PRODUCTS

6.1. The Supply Prices for the Products for the duration of this Agreement are set out in Appendix 1 to this Agreement.

6.2. In the event that the Net Selling Price for any or all of the Products in a Country within the EEA declines by more than *** percent (***%) from the Net Selling Price at the time of Launch or *** percent (***%) below the lowest ex factory price of Products within other countries within the EEA, whichever is lower, the Parties shall promptly meet and discuss with a view to agree upon a revised Supply Price during the period of the reduced Net Selling Price. In the event of a decline in the Net Selling Price for a Product resulting in the Supply Price falling below GW’s cost of Manufacture for the Products, the Parties shall promptly meet and discuss with a view to agree upon a revised Supply Price during the period of the reduced Net Selling Price. GW shall not be obliged to supply Bayer at a price below its cost of Manufacture with the exception of supplies of goods free of charge specified in Appendix 1.C .

7. INVOICE AND PAYMENT

7.1. The following terms shall apply:

7.1.1 Upon Delivery, GW shall raise an invoice as to total amount due assuming the Products are sold at the Estimated Supply Prices; such invoice shall be faxed or e-mailed at the invoice date to Bayer with a following hard copy by post.

7.1.2 Bayer shall undertake the following reconciliations per Commercial Year: (a) a

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

reconciliation of amounts at the end of September each year and (b) a reconciliation of amounts at the end of the third quarter of each Commercial Year, both based on amounts invoiced at the Estimated Supply Prices and the Net Sales made during the period between each reconciliation. Bayer shall send the full details of the reconciliation to GW within forty-five (45) days of the end of each reconciliation period. Any underpayments shall be paid to GW against the provision by GW of an invoice in respect of such sum and any overpayment made by Bayer shall be repaid by GW sent with an accompanying statement. Payments to be made to either Party shall be made within sixty (60) days following the reconciliation.

7.1.3 Appendix 1.C shall apply in the event that Product is sold to wholesalers and/or pharmacies in the Territory by authorised wholesalers and/or retailers importing Product from outside the Territory provided that (a) Clause 7.1.3 shall not apply as long as (i) Bayer Sales are ***

, and (b) this Clause 7.1.3 shall cease to apply if Bayer exercises its Territory Option according to Clause 3 for the entire EEA.

7.2. Each invoice issued by GW hereunder in each Country shall specify:

(a) the order number;

(b) the Estimated Supply Prices and Supply Price percentage in respect of the Products Delivered;

(d) the quantity of the Products Delivered;

(e) the currency (provided that the Parties shall in good faith agree on the currency applicable to the invoices relating to each of the countries within the Territory); and

(f) the amount of VAT (as defined in Clause 7.5 below (if any)) due in respect of the invoiced amount.

7.3. Subject to Clause 7.5 below, payment with respect to each Country shall be made within thirty (30) days after the date of the invoice.

7.4. Bayer shall provide to GW on a monthly basis details of its Gross Sales and Net Sales in each Country and on a Product by Product basis to enable GW to verify the same within thirty (30) days from the end of each month.

7.5. All amounts in this Agreement are stated exclusive of Value Added Tax or other sales tax applicable in any Country or the Territory (“VAT”). If VAT, which is or may become properly payable or chargeable in respect of the payments, becomes payable by Bayer, then GW will promptly provide a valid VAT invoice to Bayer. If the VAT charged to and paid by Bayer is subsequently refunded by any relevant fiscal authorities to GW, then such refund shall be promptly forwarded to Bayer with a valid VAT credit note.

7.6. Bayer shall keep and shall cause its Affiliates to keep complete and accurate records of all Gross Sales and Net Sales of the Products in each Country and GW shall have the right, at GW’s expense, through a certified public accountant or like person reasonably acceptable to Bayer, to examine such records during regular business hours during the life of this Agreement and for six (6) months after its termination; provided however that such examination shall not take place more often than once a

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

year and shall not cover such records for more than the preceding two (2) years and provided further that such accountant shall report to GW only as to the accuracy of Net Sales. All such costs and expenses in connection with performing any such examination shall be paid by GW unless the examination discloses at least a *** (***%) per cent shortfall, in which case Bayer will bear the full cost of such examination.

8. FAILURE TO SUPPLY; SECURITY OF SUPPLY

8.1. Bayer shall notify GW as soon as reasonably practicable if there is an incomplete Delivery in any Country having regard to the permitted margin of ***% (*** percent) variance in the Firm Order quantities as detailed in Appendix 5 in accordance with the terms of this Agreement. If GW is notified by telephone or in person then such notification shall be confirmed by Bayer in writing. The alleged incomplete Delivery shall then be promptly investigated by the Parties and in the event that it is established that Delivery is in fact incomplete, GW shall then be obliged to rectify the incomplete consignment within twenty (20) business days, from the later of the date of written notification or the Parties reasonably establishing that that Delivery is in fact incomplete.

8.2. If GW is unable, or anticipates that it will be unable, to supply the Products in accordance with any Firm Orders or Semi-Firm Orders placed in accordance with Appendix 5 for any reason other than for reasons set out in Clause 16 of the Licence and Distribution Agreement incorporated by reference to this Agreement by Clause 19 of this Agreement, the following provisions shall apply:

8.2.1 In respect of the Products for which permitted shelf life is less than *** (***) months, GW shall, as soon as it becomes aware of the fact, give written notice to Bayer of the reasons for the shortfall.

8.2.2 In respect of the Products for which permitted shelf life is equal or greater than *** (***) months, GW shall, as soon as it becomes aware of the fact, and in any event not less than fourteen (14) days before the due Delivery date, give written notice to Bayer of the reasons for the shortfall. Bayer shall notify GW in the event that its stock levels fall below the forecasted level.

8.2.3 Upon service of the notice referred to in Clauses 8.2.1 and 8.2.2 above, the Parties shall enter into discussions in good faith with a view to alleviating its effects or agreeing alternative supply arrangements.

8.2.4 Clauses 8.2.5 to 8.2.9 shall only apply where Bayer can demonstrate to the reasonable satisfaction of GW that Bayer will as a result of such inability to supply be out of stock or where Bayer reasonably anticipates being out of stock of the Products during the period for which GW, other than for reasons of delay caused by the acts or omissions of a Governmental Authority, reasonably anticipates that supply of the Products by GW will be interrupted (“Out of Stock Situation”). For the avoidance of doubt, Clauses 8.2.4. to 8.2.7 shall not apply where Bayer is out of stock due to market demand being in excess of the Firm Order or Semi-Firm Order quantities or where the Out of Stock Situation arose as a result of Bayer not exercising prudent stock management disciplines.

8.2.5 Should the Parties have failed to have agreed remedial action in accordance with Clause 8.2.3 during a period of sixty (60) days and Bayer is or reasonably

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

anticipates being out of stock during the continuing period of interruption reasonably anticipated by GW, then Bayer shall be entitled to take over the partial or total Manufacture of the Products.

(i) Bayer shall have the right either to manage that stage of the Manufacture currently undertaken by one or more of the Authorised Contractors or GW or alternatively assume the Manufacture itself of that part of the Manufacturing process and this Agreement shall be amended appropriately to reflect the revised arrangements during which period Bayer shall assume the Licence to Manufacture, subject to appropriate regulatory approvals being obtained.

(ii) Depending upon whether Bayer has partial or total responsibility, GW shall become a contractor to Bayer in respect of the first stage of the Manufacturing process and if necessary, at Bayer’s request GW shall assign its contracts with the Authorised Contractors to Bayer.

(iii) The Manufacturing Licence shall become a sole licence as provided by Clause 2.4 of the Licence and Distribution Agreement.

(iv) During the period of Manufacture by Bayer the Supply Prices shall be adjusted by good faith negotiation between the Parties enabling GW to receive payment for the Licence to Manufacture based on the Supply Prices but subject to deduction of Bayer’s costs of Manufacture so as to reflect the reasonable costs of Manufacture incurred by Bayer under the revised Manufacturing arrangements required to fulfil Bayer’s sales volumes of the Products for the Territory, and GW’s costs relating to the Manufacture of the Products previously included by GW within the Supply Prices.

8.2.6 GW shall give reasonable assistance to Bayer in transferring Manufacturing to such location or third party as Bayer shall nominate from GW and any of the Authorised Contractors to Bayer on terms of confidence, including reasonable assistance with transferring GW’s Manufacturing Know-How for Manufacture and Confidential Information provided that such third party shall be obliged to maintain the same degree of confidentiality as Bayer under this Agreement. In relation to the transfer of Manufacturing Know-How, GW shall provide ten (10) Person Days of assistance at no cost to Bayer. This Clause 8.2.6 shall apply mutatis mutandis whereby Bayer, at the end of the period referred to Clause 8.2.5 above shall retransfer Manufacturing to GW or any of the Authorised Contractors.

8.2.7 The Manufacturing Know-How and any other information supplied for the purposes of Manufacture shall be treated by Bayer as Confidential Information of GW and Bayer shall not disclose the same except to the third party referred to in Clause 8.2.6. Bayer shall procure that all third parties to which it discloses any such Confidential Information shall also keep it confidential on terms no less onerous than those contained in Clause 8 of the License and Distribution Agreement.

8.2.8 In circumstances where the Parties have reasonably agreed that the continuing period of interruption has ceased and GW wishes to assume the Manufacture of the Products and can reasonably demonstrate to Bayer that it is able to Manufacture the Products to a quality equivalent to that Manufactured by Bayer at the time of cessation, GW shall provide one (1) month’s notice to Bayer during which period the Parties shall define the process for Manufacture to Bayer so as to ensure no interruption in supply to patients. Upon the resumption of Manufacture by GW, the rights granted under Clause 8.2.5 shall automatically cease and Bayer shall promptly return

all Manufacturing information together with such Confidential Information and information provided for the purposes of Manufacture. Bayer shall use its best endeavours to assign back to GW those contracts previously assigned to Bayer with the Authorised Contractors for the purposes of Manufacture by Bayer.

8.2.9 Any Manufacture undertaken by Bayer under the provisions of Clause 8.2.5 of this Agreement would be to fulfil Bayer’s requirements for the sale of the Products in the Territory. On request by GW, Bayer agrees to supply the Products on reasonable commercial terms to GW or any other party for sale outside the Territory.

8.3. Notwithstanding Clause 8.2 above, the Parties intend to minimise the effect of an Out of Stock Situation and to ensure a continuous and adequate supply of the Product to Bayer in accordance with the terms of this Agreement.

8.3.1 GW has prior to the Effective Date qualified and validated GW’s site in ***, *** and *** for the growing and extracting stage of the Manufacture of the Product and hereby agrees to qualify and validate, at its own cost and expense, a second site for extraction stage of the Manufacture of the Product (the “Second Site”) as soon as practicable after the Effective Date.

8.3.2 GW shall, within thirty (30) business days after the Second Site and — at Bayer’s option — a second site for the packaging to be established by Bayer (the “Bayer Site”) are qualified and validated, apply for and effect any changes, variations or amendments to any relevant Marketing Authorisation that may be required to ensure that the Second Site and the Bayer Site can be used immediately upon the occurrence of an Out of Stock Situation. Bayer shall provide to GW all reasonable co-operation and assistance that may be necessary to enable GW to carry out its obligations hereunder.

8.3.3 GW shall during the term of this Agreement at its own cost and expense prepare, maintain and update the Manufacturing Know How as necessary and as agreed between the Parties so that the Manufacturing Know How is at all times capable of being used to Manufacture or have Manufactured Product. If Bayer specifically requests at any time that the Manufacturing Know How be updated GW shall promptly do so at Bayer’s cost and expense.

8.4. In the event of an Out of Stock Situation or where Bayer would be entitled to terminate this Agreement pursuant to Clause 16.4 upon GW compounding or making any arrangement with its creditors or having a receiver appointed over all or any part of its assets or going into liquidation (whether voluntary or otherwise) save as part of a bona fide reconstruction not involving insolvency or shall take or suffer to be taken any similar action as a result of its liability to pay its debts or its insolvency, then:

8.4.1 the Manufacturing Know How shall be immediately released to Bayer;

8.4.2 Bayer shall be granted a non-exclusive, royalty free, sub-licensable, irrevocable licence to use the Manufacturing Know How (as updated from time to time) to Manufacture or to have Manufactured the Product;

8.4.3 GW shall in accordance with legislative and regulatory requirements transfer to Bayer or its nominee ownership of the Marketing Authorisation in the Territory. In the event that such transfer is not possible GW shall use reasonable endeavours to ensure that Bayer has the benefit of the Marketing

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Authorisation, and, to this end, consents to any Governmental Authority cross-referencing the data and information on file with any Governmental Authority as may be necessary to facilitate the granting to Bayer of second marketing authorisations in respect of the Product in the Territory; and

8.4.4 GW agrees to complete whatever other procedures are reasonably necessary in relation to the same to enable Bayer (either itself or in conjunction with a third party) freely to Manufacture and sell the Product in the Territory. For this purpose, GW shall execute and deliver to Bayer on the Effective Date a power of attorney in the form attached hereto in Appendix 4 . Bayer undertakes only to complete and use such power of attorney in the circumstances, if (a) Bayer notified GW in writing of such intended use of the power of attorney, and (b) GW did not provide the reasonably requested support promptly after receipt of such request, and (c) Bayer attempted to discuss and negotiate with GW in good faith a timely resolution, provided that such negotiation period shall not exceed ten (10) business days and, if longer, the period Bayer can reasonably wait until use of the power of attorney is required.

9. QUALITY OF PRODUCTS

9.1. GW shall ensure that each Delivery of the Products supplied to Bayer hereunder is accompanied by a Certificate of Analysis. The Products will be supplied in accordance with the requirements of the Quality Agreement between GW and Bayer and in compliance with the agreed Specifications and Acceptable Quality Levels (AQLs) detailed therein. Bayer shall notify GW of any visually apparent defects in any quantity of the Products Delivered to it within eight (8) business days of the date of Delivery to Bayer’s premises. Within eight (8) business days of receipt of the Products from GW ordered pursuant to this Agreement, Bayer shall have the right but not the obligation, to analyse or cause to be analysed, any shipment of the Products. If in Bayer’s reasonable opinion such analysis reveals any defects in such shipment by reference to the Specifications, Bayer shall immediately notify GW in writing thereof and send samples of that shipment to GW.

9.2. Bayer shall notify GW in writing within thirty (30) business days of its visual inspection (or within five (5) business days of becoming aware of any Latent Defects) of any complaints or issues arising as to the quality of the Products and send a sample of the defective Product(s) to GW. Additionally if a potential defect may constitute a hazard to patient safety such reporting should be within twenty four (24) hours of Bayer becoming aware of such defect, initially by telephone and promptly followed up in writing.

9.3. If GW is satisfied and has agreed that the relevant shipment of the Products is defective due to GW’s default, Bayer shall dispose of such defective shipment of the Products as GW shall direct in writing and at GW’s reasonable expense and GW shall use its reasonable efforts to supply new Products to Bayer as soon as reasonably possible thereafter PROVIDED THAT if the Parties fail to agree whether the shipment is defective or, if defective whether the defect is due to GW’s default, the matter shall be referred to the Laboratory to be tested in the presence of representatives of both the Parties within fourteen (14) days to determine whether the shipment complies with the Specifications. The costs of such testing shall be borne by GW in the event it is established by the Laboratory that the Products fail to comply with the Specifications. In circumstances where it is established by the Laboratory that the Products are within the Specifications Bayer shall bear the costs of such testing. If, notwithstanding the foregoing provision, GW has invoiced Bayer in respect of such Products GW shall credit BAYER with the value of such invoiced Products if the Products fail to comply with the Specifications. Pending the outcome of any such dispute, GW shall use its reasonable efforts to ensure that Bayer remains in stock of the Products.

9.4. Subject to Clause 9.2, in the absence of any notification in writing to the contrary by Bayer within twenty (20) business days of receipt of the Products by Bayer the Products shall be deemed to have been accepted by Bayer.

9.5. GW shall provide a reasonable volume of samples of the Products to Bayer for quality assurance purposes on a free of charge basis.

10. SUPPLY AND STORAGE OF MATERIALS AND PRODUCTS

10.1. GW shall be solely responsible for ordering the required quantities of Intermediates. GW shall purchase and use only Intermediates and use such procedures in the Manufacture of the Products, which comply with the requirements of the Marketing Authorisations and with Good Manufacturing Practice and where such Intermediates otherwise are fit for purpose. GW shall at all times ensure that all Intermediates and Products Manufactured by GW pursuant to this Agreement are stored and warehoused in compliance with the Manufacturing Licence and otherwise in accordance with Bayer’s reasonable written requirements. GW shall operate a warehousing system which identifies all the Products according to type and status. GW shall comply with any reasonable written requirements of Bayer or a Governmental Authority relating to the security of controlled drugs and cold storage.

10.2. GW shall be responsible for ensuring that where Manufacture is contracted out to Authorised Contractors, such Authorised Contractors comply with the requirements of Clause 10.1 above.

10.3. Bayer or its Affiliates shall comply with the requirements of the Manufacturing Licence or any Wholesale Dealers Licence(s), GMP and otherwise in accordance with GW’s reasonable written requirements in respect of the storage and warehousing of the Products. Bayer shall comply with any reasonable written requirements of GW or a Governmental Authority relating to the security of controlled drugs and cold storage.

10.4. Bayer shall be responsible for ensuring that, where warehousing, transport, storage and distribution is contracted out, its contractors will comply with the requirements of Clause 10.3 above.

11. MARKETING AUTHORISATIONS

11.1. GW undertakes to observe and comply with all requirements of the valid Marketing Authorisations and any amendments or additions thereto in so far as they apply to the Manufacture of the Products hereunder and have been disclosed by GW to Bayer or its Affiliates in writing.

11.2. GW undertakes to inform Bayer or its Affiliates of any amendments or additions to the Marketing Authorisations which are relevant to the performance by Bayer of its obligations under this Agreement at which time the Agreement shall be amended in accordance with the amendments or additions implemented by GW in the Manufacture of the Products to the extent required.

12. MANUFACTURE OF PRODUCTS

12.1. GW shall at its own cost obtain and throughout the term of this Agreement maintain all necessary Manufacturing Licences or procure that Manufacturing Licences are maintained by the Authorised Contractors and perform its, or procure the performance by the Authorised Contractors of their, obligations hereunder in accordance with the Manufacturing Licences and all applicable laws and legislation in the Territory. GW shall supply a copy of each such Manufacturing Licence to Bayer or its Affiliates free of charge on written request.

12.2. All personnel employed by GW or the Authorised Contractors in the Manufacture of the Products shall be suitably trained, experienced and competent for their respective functions with particular reference to performing their assigned duties in accordance

with Good Manufacturing Practice. GW shall, or shall procure that the Authorised Contractors shall, keep written records of the training provided to such employees, copies of which shall be made available to Bayer on request.

12.3. GW covenants with Bayer not at any time during the term of this Agreement to carry out any other activities that may, to GW’s knowledge at the time of the said activity, prejudice the quality, safety or efficacy of the Products.

13. LABELLING AND ARTWORK

13.1. GW shall Manufacture the Products incorporating such design, Trade Mark and artwork as may be agreed in writing from time to time between the Parties.

13.2. GW shall bear the initial costs in respect of preparation of artwork and labels for the Products for Launch in the UK. Bayer shall bear any subsequent costs for changes to artwork or labelling requested by Bayer during the term of this Agreement. Bayer shall bear the write-off costs in respect of packaging components, resulting from artwork or labelling changes requested by Bayer, provided that the volume of such components is no greater than that required to fulfil Bayer’s then forecast Firm and Semi-Firm requirements for the affected Products.

13.3. GW shall bear the artwork and labelling costs arising from any artwork and labelling changes instigated by the Governmental Authority or arising for regulatory reasons implemented by GW as holder of a Marketing Authorisation.

13.4. Save as required by any applicable law or regulation and as provided for by Clause 11.2 of the Licence and Distribution Agreement, GW will not affix to any of the Products any trade mark (other than the Trade Mark unless otherwise agreed by GW and Bayer), business names, labels or signs other than as may previously have been approved in writing by Bayer (Bayer’s agreement not to be unreasonably withheld or delayed).

13.5. Save as required by any applicable law or regulation, GW shall not make any change to the layout, content or appearance of any labelling of any of the Products without the prior written consent of Bayer (Bayer’s agreement not to be unreasonably withheld or delayed).

14. HAZARDS

GW will inform and keep Bayer informed of all hazards, regulations and guidance (statutory or otherwise) which GW knows or believes to be associated with the use, handling, storage labelling, transport, treatment and disposal of the Products and GW will ensure that relevant consignments are safe, packaged, labelled so as to prevent any health risk to persons, property or the environment and properly marked with the appropriate internationally recognised danger symbols and that prominent hazard warnings appear on all packages and documents.

15. WARRANTIES AND INDEMNITY

15.1. GW hereby represents and warrants that:

(a) the Products supplied hereunder shall conform to the Specifications; and

(b) the Products shall be Manufactured in accordance with Good Manufacturing Practice and the processes set out in this Agreement;

(c) it will convey good title to the Products supplied hereunder and that the Products will be delivered free from any lawful security, interest, lien or encumbrance.

15.2. Bayer hereby represents and warrants that the Products shall be stored and distributed in accordance with GDP and the processes set out in this Agreement.

16. DURATION AND TERMINATION

16.1. This Agreement shall continue for fifteen (15) years (“Initial Term”), unless (a) the License and Distribution Agreement is terminated earlier in which case this Agreement shall also terminate or (b) earlier terminated in accordance with this Clause 16. This Agreement shall continue for successive twelve (12) month periods thereafter unless Bayer terminates by serving at least twelve (12) months’ written notice prior to the end of the Initial Term and prior to the end of each successive calendar year after such Initial Term.

16.2. Notwithstanding Clause 16.1, the obligation of Bayer according to Appendix 5 to purchase its entire requirement of Product from GW shall only apply for a period of *** (***) years from Launch of the Products in the Territory.

During the Initial Term, the following shall apply: Upon written request of GW of not less than *** (***) months prior to the end of such period, the Parties shall meet and discuss whether Bayer in its sole discretion wants to agree on a renewal for a period of further *** (***) years on the same terms set forth above. Should Bayer agree to such renewal, the Parties shall agree on forecast for sales which shall form the basis for the calculation of the supply prices, as set out in Appendix 1 . Should Bayer not agree to such renewal in writing within *** (***) months following receipt of the request by GW, GW has the right but not the obligation to terminate this Agreement and the Licence and Distribution Agreement with a eleven (11) month written notice to be provided prior to the expiration of the respective *** (***) year term. For the avoidance of doubt, in the event that GW does not request a meeting in writing prior to the said *** (***) month period or does not provide the said eleven (11) months’ written notice, the provisions contained in this Agreement relating to the obligation of Bayer to purchase the entire requirement of Product and the right of GW to terminate the Agreement shall be deemed to be deleted after expiry of the said *** (***) year period and the Agreement shall continue thereafter in accordance with all remaining terms.

16.3. If either party to this Agreement shall commit any material breach excluding failure to supply or delayed in Delivery of this Agreement and not remedy the breach within sixty (60) days of notice from the other Party so to do (if capable of remedy) the other Party may terminate this Agreement immediately by notice in writing to the Party in breach.

16.4. If either Party shall compound or make any arrangement with its creditors or have a receiver appointed over all or any part of its assets or go into liquidation (whether voluntary or otherwise) save as part of a bona fide reconstruction not involving insolvency or shall take or suffer to be taken any similar action as a result of its liability to pay its debts or its insolvency it shall promptly so notify the other Party in writing giving particulars of the circumstances whereupon the other Party may terminate the Agreement immediately by notice (for the avoidance of doubt, Bayer may terminate the Agreement upon the occurrence of any of the circumstances described in this Clause 16.4 notwithstanding that GW may not have given notice to Bayer as required).

16.5. If Bayer ceases to sell the Products for a significant technical or regulatory reason (and a significant technical or regulatory reason for these purposes is agreed to include, without limitation, any adverse technical or regulatory impact for Bayer that is or may be attributable in whole or in significant part to the use by Bayer of the Product(s)) either Party may terminate this Agreement on giving six (6) months’ notice

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

provided, however, that the Party learning of such technical or regulatory impact shall immediately notify the other of the same, and, as appropriate, work together diligently and in good faith to remedy such impact during the notice period or such other period as the Parties shall agree in writing.

17. CONSEQUENCES OF TERMINATION

17.1. On termination of the Agreement GW shall, not later than seven (7) days after Bayer’s request but at Bayer’s cost:

(a) Bayer shall notify GW of the amount of the Products in its possession and Bayer shall be permitted to sell those amounts of the Products for a period of up to one hundred (180) days after termination provided that Bayer shall pay the payments thereon at the time provided herein;

(b) each Party to return to the other Party all other documents provided to it, other than those documents provided as part of the Manufacturing Information if Bayer has assumed its rights to Manufacture under Clause 8.2.5;

(c) ensure that all copies (save one (1) for the purposes of demonstrating compliance with this Agreement) of Confidential Information, know-how and/or any information of a technical nature relating to the Products and the Manufacture of the Products or of a confidential nature and supplied by one Party to the other is returned or destroyed by GW at Bayer’s option or Bayer at GW’s option; and

(d) Bayer shall pay all sums due to GW under any invoices provided by GW in respect of supply of the Products hereunder.

17.2. On termination of the Agreement Bayer shall, not later than seven (7) days after GW’s request return to GW all other documents provided to Bayer by GW; with the exception of any records required to be kept for the purposes of complying with GMP.

17.3. Termination of this Agreement or withdrawal of any of the Products from the Agreement shall be without prejudice to the continuation in force of Clauses 7 of this Agreement and Clauses 8 and 17 of the License and Distribution Agreement and any other obligations otherwise provided by this Agreement which have accrued. In addition, any other provision required to interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement. Furthermore, GW agrees to provide Bayer with all reasonable support with respect to any investigation reasonably required by Bayer or any Governmental Authority with respect to Manufacture of the Products carried out prior to such termination or withdrawal even after such termination or withdrawal provided that GW’s reasonable costs in providing such assistance shall be at Bayer’s cost unless the Agreement has been terminated by Bayer for a reason contained in Clause 17.2 above.

17.4. Termination or expiry of this Agreement shall not release either Party hereto from any liability or right of action which at the time of termination has already accrued to either Party hereto or which may thereafter accrue in respect of any act or omission prior to such termination. Such rights shall include but not be limited to the recovery of any monies due hereunder.

18. AUTHORISED CONTRACTORS

18.1. As at the Effective Date, GW has appointed and executed binding agreements with Authorised Contractors to carry out its obligations under this Agreement.

18.2. Notwithstanding Clause 10.2 above, GW shall remain liable to Bayer for the performance of all its obligations and shall ensure that the contracts between GW and such Authorised Contractor comply with and reflect the provisions of this Agreement.

In particular, such contracts shall contain (a) a Quality Agreement, (b) the prior written approval of Authorised Contractors in respect of the assignment of the contracts to Bayer under Clause 8.2.5 above and (c) a satisfactory level of protection in the event an Authorised Contractor compounds or makes an arrangement with its creditors or has a receiver appointed over all or any part of its assets or goes into liquidation (whether voluntary or otherwise) save as part of a bona fide reconstruction not involving insolvency or shall take or suffer to be taken any similar action as a result of its liability to pay its debts or its insolvency during the term of this Agreement , including, but not limited, to GW’s first right to acquire all or any of the facilities, equipment, materials and other assets and consumables used by Authorised Contractor in the performance of services relating to Products. It is understood by Bayer that such protection is always at the discretion of the administrator or receiver of the Authorised Contractor.

18.3 GW shall not without the prior written consent of Bayer (which shall not be unreasonably withheld or delayed) appoint any other contractor during the term of this Agreement to carry out its obligations hereunder. Clauses 18.1 and 18.2 shall apply accordingly.

19. REFERENCE

Clauses 8 and 15 to 24 of the License and Distribution Agreement shall also apply to this Supply Agreement.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of		Signed for and on behalf of
BAYER AG		GW PHARMA LIMITED


Leverkusen, 20 May 2003		Salisbury, 20 May 2003


/s/ Dr. Dietrich Brocks		/s/ Justin Gover
Dr. Dietrich Brocks		Justin Gover
Head of International Cooperations		Managing Director
and Licensing Europe


/s/ Dr. Dirk Ehle		/s/ David Kirk
Dr. Dirk Ehle		David Kirk
Law and Patents		Finance Director

APPENDIX 1

THE SUPPLY PRICES

For Net Sales in each Commercial Year the Supply Prices are to be calculated as *** percent (***%) of Net Selling Price. For Net Sales in each Commercial Year above *** percent (***%) of the Net Sales forecasts below for that Commercial Year, *** percent (*** %) of the Net Selling Price shall be added to the Supply Price for the incremental quantity (for the avoidance of doubt, in respect of such incremental sales, the Supply Price is *** percent (***%) of the Net Selling Price). Upon submission to the Medicinal Products Regulatory Authority to include the indication relief of cancer pain to the Indications the parties shall agree to an increased Net Sales Forecast to reflect the Net Sales for all Indications.

A. United Kingdom

Sales in the Territory of the Products

Commercial Year		Net Sales in £’000
1		***
2		***
3		***
4		***
5		***
6		***
7		***
8		***
9		***
10		***

Agreed Net Sales forecasts for other Countries to be added to this Appendix in accordance with Clause 3 of the Licence and Distribution Agreement.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

In the event *** within *** (understood as *** (***) month period) fall beneath the following percentages of *** Bayer shall receive from GW *** (“***”) according to the table below. Such *** shall be calculated as a percentage of Products sold by *** in each Country during the previous ***.

Bayer Sales as a percentage of IMS Sales		Percentage of Bayer Sales as free goods
***	%	***	%
***	%	***	%
***	%	***	%
***	%	***	%
***	%	***	%
***		***	%

The *** shall be delivered within *** scheduled according to Appendix 5 following the reconciliation.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

APPENDIX 2

DRAFT SPECIFICATIONS OF PRODUCTS

Test	Test Method	Limits

***	***	***
***	***	* *
***	***	***
* - * - ***	* *	* *
* - * - ***	***	* *
*: - * - ***	* *	* *
***:	***	***

The drug product is a solution containing THC and CBD botanical extracts. The specification for the control of 27mg/ml THC and 25mg/ml CBD BDP has been provided.

Please note:

The *** specification stated above is the proposed specification for commercial release of the finished product. *** has been provided to show compliance with the existing in-house ***. The specification for *** has been extended significantly as a result of the availability of additional *** that allow the identification of *** .

Analytical Procedures: The analytical procedures used in the control of *** are in-house methods.

In-house methods:

· ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

APPENDIX 3

QUALITY AGREEMENT

- to be attached -

APPENDIX 4

POWER OF ATTORNEY

THIS DEED is made on 20 May 2003 by GW Pharma Limited whose registered office is at Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ (“GW”)

WHEREAS, GW has become a party to an agreement of even date herewith with Bayer AG (the “Agreement”) in relation to the supply of a medicinal product and is obliged, inter alia, pursuant to Clause 8.4.4 thereof to deliver to Bayer AG a power of attorney in the form of this Deed.

NOW THIS DEED WITNESSES AS FOLLOWS:

1. Appointment of Attorney

GW hereby irrevocably and unconditionally (and by way of security of the performance of its obligations under the Agreement) appoints Bayer AG as its attorney (the “Attorney”) to execute and do in its name or otherwise and on its behalf all documents, acts and things which the Attorney shall in its absolute discretion consider necessary or desirable in order to implement GW’s obligations under clause 8.4 of the Agreement.

2. Ratification

GW undertakes to ratify whatever Bayer AG, as its Attorney, shall lawfully do or cause to be done in accordance with this Power of Attorney.

3. Governing Law

This Deed shall be governed and construed in accordance with the laws of England.

IN WITNESS whereof GW Pharma Limited has executed this Deed the day and year first before written.

EXECUTED as a Deed by GW Pharma Limited

Acting by
	Director


	Director/Secretary

APPENDIX 5

ORDERS FOR PRODUCTS

The following provisions apply under the provisions of Clause 3 in relation to the following countries of the Territory:

PART A

UK Territory

1. Bayer or its Affiliate shall provide to GW by the first Day of each month with a forecast APPENDIX of demand for the Products for each Country for at least the following eighteen (18) months (“Forecast APPENDIX”). The Forecast APPENDIX shall be updated monthly. In addition and subject to Clauses 2 — 7 below, Bayer shall provide GW during the fourth (4th) quarter of each calendar year with an annual forecast for the following calendar year which shall serve as a basis for the ordering system and shall not contain binding orders but quantities corresponding to the first twelve (12) months of the Forecast APPENDIX. Against this annual forecast Bayer will formally call off the respective quantities.

2. The quantities of the Products detailed in the first *** (***) months of each Forecast APPENDIX (“Firm Order Period”) shall (to the extent set out in Appendix 5 ) constitute a binding commitment on Bayer in relation to each Country to purchase such quantities of the Products from GW on the terms and conditions of this Agreement (“Firm Order”). With respect to each Country Bayer shall issue to GW a Firm Order for the quantity of the Products ordered for the Firm Order Period not later than *** (***) weeks prior to the Delivery date specified therein. The Firm Order shall specify the arrangements for Delivery of the Products. The Parties agree that all Firm Orders for the Products placed by BAYER with GW under this Agreement shall be supplied on the terms of this Agreement.

3. In determining Firm Order quantities for each Country Bayer shall take account of Manufacturing batch sizes, such that Bayer must accept as fulfilled orders actual quantities of Products Manufactured which are within a margin of *** (***) percent of the Firm Order quantity. In the event GW supplies quantities in an aggregated shortfall of more than *** (***) percent, then GW shall be obliged to make up such shortfall quantities as early as possible. The initial Manufacturing batch sizes for the Products shall be *** and *** and any variance to this quantity shall be notified by GW to Bayer in writing.

4. The volumes detailed in the next *** (***) months after the Firm Order Period of the Forecast APPENDIX (the “Semi-Firm Order Period”, being months ***) shall represent a semi-firm order for each Country, meaning that Bayer shall be obliged to order and purchase at least ***% of the initial forecast for any month *** forecast. For the avoidance of doubt the initial forecast for any month *** forecast may not vary by more than thirty percent by the time that forecast becomes a Firm Order. GW shall hold sufficient stocks of intermediates to meet the forecast requirements during the Firm Order Period and up to *** percent (***%) of the forecast requirements detailed in the Semi-Firm Order Period. Both Parties shall conduct their businesses so as to

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

minimise any stock write-offs. Bayer may ask GW for additional quantities to be manufactured and delivered by GW. GW shall use its reasonable efforts to comply with Bayer’s additional demand. In any case GW shall give notice to Bayer within ten (10) business days of the receipt of the written order of its ability to meet the additional quantity.

5. GW shall respond to each Firm Order received from Bayer within three (3) business days of receipt. The response shall include confirmation of the Delivery dates and quantity as set out in the Firm Order. In the event that discussion is required regarding the timings of production and Delivery then the relevant planning personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Forecast APPENDIX within four (4) business days of receipt by GW of the original Forecast APPENDIX except during the period 20 th December to 6 th January in each year when the periods of three (3) or four (4) business days referred to herein shall be replaced by eight (8) business days in each case.

6. It is understood that volumes detailed in relation to the remaining *** (***) months of the Forecast APPENDIX after the Firm Order Period and the Semi-Order Period constitute an estimate of the future Product requirement of Bayer and its Affiliates for each Country within the Territory and do not comprise any minimum purchase requirement or any binding commitment by Bayer or its Affiliates to purchase such volume of the Products.

7. Binding orders subject to approval in the Territory for Bayer’s requirements of Launch Stocks shall be provided by Bayer for the UK within ten (10) business days of the Effective Date. The delivery date shall be agreed by the UK Country Commercialization Committee. Bayer shall notify GW in writing of the Delivery date for the Launch Stocks at least ten (10) weeks before due delivery date specified for Launch.

PART B

...

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

APPENDIX 6

DELIVERY OF PRODUCTS

The following provisions apply under the provisions of Clause 4 in relation to the following countries of the Territory:

PART A

UK Territory

1. GW shall procure that the Products Manufactured hereunder are Delivered in each Country in accordance with the provisions of this Agreement. The costs of Delivery of the Products from GW or the premises of its Authorised Contractor as appropriate to Bayer’s nominated distribution centre or other nominated location in the Country in question shall be borne by Bayer.

2. With respect to Launch Stocks and for all the Products Manufactured with a maximum permitted shelf life of twelve (12) months, there shall be a minimum of ten (10) months’ shelf life remaining on the Products at the date of Delivery requested by Bayer on each Bayer order. In the case of any of the Products with less than ten (10) months’ shelf life, the Products shall be returned to GW at GW’s reasonable cost and replaced with Product having the required shelf-life at no cost to Bayer, unless Bayer accepts these Products for sale.

3. In the event that the shelf-life permitted by a Governmental Authority applicable to a Country is extended beyond twelve (12) months or to any other period the Parties shall negotiate in good faith and agree in writing the revised shelf life remaining on the Products upon Delivery to Bayer and the date upon which the first Delivery shall be made of the Products with such extended shelf-life PROVIDED ALWAYS THAT at the date of Delivery requested by Bayer on each Bayer order the shelf life remaining on the Products at the date of Delivery shall be at least *** percent (***%) of the total shelf life available for the Products or *** months. In the event that the said Governmental Authority approves an extension to the shelf-life beyond twelve (12) months or approval for the 14 ml vial (gross) size, the Parties shall develop an implementation and transition plan to minimise write-off costs for the 8 ml gross vial and to ensure minimum disruption to patients and any write-offs costs shall be shared equally. Bayer shall undertake to launch the 14 ml gross vial for the Products, upon agreement as to the transitional arrangements, and subject to approval by the Governmental Authority and availability of stocks of the Products from GW to satisfy Bayer’s Firm Order requirements.

4. In the event of a delay caused by the acts or omissions of a Governmental Authority in a Country resulting in a delayed Launch beyond the Launch date to be agreed between the parties in writing and Bayer is not able to sell such part or all of the Launch Stocks, the Parties shall equally share GW’s write-off costs of the destruction of any Launch Stocks of the Products calculated in accordance with Appendix 5 . GW shall provide replacement stocks in respect of any destroyed Launch Stocks as soon

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as is reasonably practicable. If GW has invoiced Bayer with any proportion of such destroyed Launch Stocks GW shall credit Bayer with the invoiced value of that proportion of the Launch Stocks.

5. In the event that GW fails to deliver in response to the Firm Orders for the Products for a Country on the specified Delivery date by reason of delay, GW shall provide a revised Delivery date. In the event that Delivery is more than ten (10) business days later than the original specified Delivery date, GW shall provide to BAYER an action plan to achieve the revised Delivery date. In circumstances where Delivery has not been achieved within twenty (20) business days from the original Delivery date and Bayer is able to demonstrate that it has thereby suffered a material stock shortage of the Products at its nominated distribution centre ***

:

***		***

***		***

***		***

***		***

For the avoidance of doubt the above discount rates shall not be applicable if the shortage of the Products is due to demand in excess of the Firm Orders or Semi-Firm Orders as the case may be.

PART B

...

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.8

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

AMENDMENT NUMBER 1

TO THE SUPPLY AGREEMENT

WHEREAS , Bayer AG and GW executed a Supply Agreement as of the 20 th day of May 2003;

WHEREAS , Bayer AG transferred its entire healthcare business including all contractual rights and obligations to its 100% subsidiary Bayer HealthCare AG with effect of October 1, 2003, as permitted in accordance with. Clause 19 of the Supply Agreement and Clause 22.2 of the License and Distribution Agreement;

WHEREAS , Bayer decided to exercise its option under clause 3.1 of the License and Distribution Agreement for Canada;

WHEREAS , the Parties wish to agree upon the Supply Prices for Canada;

WHEREAS , in accordance with Clauses 3.2 and 4 of the Supply Agreement, the Parties will negotiate in good faith the provisions relating to orders for Products applicable to Canada as well as provisions relating to Delivery of Products applicable to Canada.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. Appendix 1 , Part B, for Canada is completed in the form attached to this Amendment.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of BAYER HEALTHCARE AG		Signed for and on behalf of GW PHARMA LIMITED

Leverkusen, 4 th November 2003		Salisbury, 4 th November 2003

/s/ ppa. D. Brocks		/s/ Justin Gover
Dr. Dietrich Brooks Head of International Cooperations and Licensing Europe		Justin Gover Managing Director

/s/ ppa Alexander Bey		/s/ David Kirk
Dr. Alexander Bey Law and Patents		David Kirk Finance Director

APPENDIX 1.B. for Canada

THE SUPPLY PRICES

In the event that only Milestone 1 or Milestone 3 as specified in Appendix 3 of the License and Distribution Agreement as amended for Canada by Amendment Number 1 has been achieved, for Net Sales in each Commercial Year, the Supply Prices are to be calculated as *** percent (***%) of Net Selling Price.

Immediately upon achievement of any additional Milestone listed in Appendix 3 of the License and Distribution Agreement as amended for Canada by Amendment Number 1, for Net Sales in each Commercial Year up to *** percent (*** %) of the Net Sales forecasts below, the Supply Prices are to be calculated as *** percent (*** %) of Net Selling Price. For Net Sales in each Commercial Year above *** percent (*** %) and up to *** percent (*** %) of the Net Sales forecasts below for that Commercial Year, *** percent (*** %) of the Net Selling Price shall be added to the Supply Price for the incremental Net Sales (for the avoidance of doubt, in respect of such incremental Net Sales, the Supply Price is *** percent (*** %) of the Net Selling Price). In respect of Net Sales in each Commercial Year above *** percent (*** %) of the Net Sales forecasts below for that Commercial Year, another *** percent (*** %) of the Net Selling Price shall be added to the Supply Price for the incremental Net Sales (for the avoidance of doubt, in respect of such incremental sales, the Supply Price is *** percent (*** %) of the Net Selling Price); provided, however, that BAYER is not entitled to a Supply Price of *** percent (*** %) according to Appendix 3, number 6 of the License and Distribution Agreement as amended for Canada by Amendment Number 1.

B. Canada

Sales in Canada of the Products

*******		*******

***		***

***		***

***		***

***		***

***		***

***		***

***		***

***		***

***		***

***		***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.9

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

AMENDMENT NUMBER 2

TO THE SUPPLY AGREEMENT

WHEREAS, Bayer and GW executed a Supply Agreement as of the 20 th day of May 2003, as amended for Canada by Amendment Number 1 to the Supply Agreement and by Amendment Number 3 to the License and Distribution Agreement;

WHEREAS, Bayer and GW wish to amend the sales forecast for the UK Territory.

NOW, THEREFORE, THE PARTIES HEREBY AGREE AS FOLLOWS:

1. Appendix 1 , Part A shall be replaced by Appendix 1, Part A, as attached to this Amendment.

IN WITNESS WHEREOF, the Parties, through their authorised officers, have executed this Agreement as of the date first written above.

Signed for and on behalf of		Signed for and on behalf of

BAYER HEALTHCARE AG		GW PHARMA LIMITED

Leverkusen, May 9, 2005		Salisbury, May 10, 2005

/s/ ppa. Dr. Horst Harenberg		/s/ Justin Gover
Dr. Horst Harenberg Head of International Cooperations and Licensing Europe		Justin Gover Managing Director

/s/ ppa. Dr. Drk Ehle		/s/ David Kirk
Dr. Drk Ehle Law and Patents		David Kirk Finance Director

Appendix 1

A. United Kingdom

Sales in the Territory of the Products

Commercial Year		Net Sales in £‘000’s

***		***

***		***

***		***

***		***

***		***

***		***

***		***

***		***

***		***

***		***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.10

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Amendment # 3

to the Supply Agreement by and between Bayer Schering Pharma AG (formerly “Bayer AG, Bayer HealthCare, Division Pharma”) and GW Pharma Limited dated May 20, 2003 — hereinafter referred to as “Supply Agreement” —

between Bayer Schering Pharma AG
Muellerstrasse 178
D-13353 Berlin
Germany
- hereinafter referred to as “BAYER” -

and GW Pharma Limited
Porton Down Science Park
Salisbury, Wiltshire SP4 OJQ
- hereinafter referred to as “GW” -

WHEREAS, Bayer AG has transferred its Division Pharma to Bayer HealthCare AG following the execution of the Supply Agreement in 2003;

WHEREAS, Bayer HealthCare AG merged with BAYER effective as of December 30, 2008, with BAYER as the universal successor so that BAYER is the new contracting party to the Supply Agreement;

WHEREAS, BAYER and GW have entered into the Supply Agreement by which GW undertook to manufacture and supply all of BAYER’s requirements for Products (as defined in the Supply Agreement) to BAYER;

WHEREAS, BAYER and GW intend to amend the Supply Agreement in respect of the Supply Prices for the first Commercial Year and the Net Sales forecast as it is relevant for the calculation of the Supply Price.

NOW, THEREFORE, the PARTIES agree to the following:

1. Unless otherwise defined in this Amendment # 3 all words written in capital letters shall bear the meaning as defined in the Supply Agreement.

2. The following sentence shall be added to APPENDIX 1 paragraph 1 as the second-last sentence:

“Such *** percent (***%) shall not be added to the Supply Price in the first Commercial Year to the effect that the Supply Price shall be *** percent (***%) throughout the first Commercial Year.”

3. The table in APPENDIX 1 Section “A. United Kingdom” shall be deleted and replaced by the following table:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Commercial Year	Net Sales £’000s	*** Net Sales	Supply Price	Supply Price for Net Sales above the ***

***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***

4. This Amendment # 3 shall form an integral part of the Supply Agreement and shall be regarded as incorporated into the Supply Agreement in every respect. All other terms and conditions of the Supply Agreement shall remain in force unchanged.

5. This Amendment # 3 shall take effect upon its execution.

6. In all other respects, the terms of the Supply Agreement shall remain unchanged.

This Amendment # 3 has been made in duplicate and signed by the PARTIES hereto.

Bayer Schering Pharma AG		Bayer Schering Pharma AG

/s/ i.v. Dr. Berthold Hinzen		/s/ i.v. Klaus Deimel
5/3/2010		8/3/2010
Dr. Berthold Hinzen Head Global Licensing General Medicine		Klaus Deimel Head Business Development Region Europe

GW Pharma Limited

/s/ Justin Gover		/s/ David Kirk
Name: Justin Gover Title: Managing Director Date: 10 March 2010		Name: David Kirk Title: Managing Director Date: 10 March 2010

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.11

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated 6 June 2006

G W Pharma Limited

– and

–

Almirall Prodesfarma, S.A.

PRODUCT COMMERCIALISATION AND SUPPLY CONSOLIDATED AGREEMENT

A MULTINATIONAL PARTNERSHIP

CityPoint, One Ropemaker Street | London EC2Y 9AW
Tel: +44 20 7920 4000 | Fax: +44 20 7496 8500

www.mofo.com

1.	DEFINITIONS	2

2.	PRINCIPAL RIGHTS	21

3.	MANAGEMENT OF THE RELATIONSHIP	21

4.	IMPLEMENTATION OF THE DEVELOPMENT PLAN AND LIFECYCLE MANAGEMENT PLAN	29

5.	COMMERCIALISATION	32

6.	MARKET STUDIES	40

7.	NEW INDICATIONS	41

8.	COMPASIONATE ACCESS PROGRAMS / NAMED PATIENT SALES / SUPPLY OF UNLICENSED SATIVEX	45

9.	GW PHARMA SUPPLY OBLIGATIONS	47

10.	FORECASTS ORDERS DELIVERY AND ACCEPTANCE	50

11.	PRICE AND PAYMENT TERMS	56

12.	PHARMACOVIGILANCE	65

13.	NON COMPETITION	67

14.	TRADE MARKS AND DOMAIN NAMES	67

15.	INTELLECTUAL PROPERTY - INITIAL FILINGS AND OWNERSHIP	71

16.	IP - MAINTENANCE PROSECUTION AND DEFENCE	71

17.	CONFIDENTIALITY AND NON-DISCLOSURE	75

18.	WARRANTIES AND UNDERTAKINGS	79

19.	INDEMNIFICATION AND INSURANCE	81

20.	TERMINATION	86

21.	CONSEQUENCES OF TERMINATION	88

22.	FORCE MAJEURE	90

23.	CHANGE OF CONTROL	91

24.	ASSIGNMENT	92

25.	GOVERNING LAW	92

26.	ARBITRATION	93

27.	NOTICES	93

28.	RELATIONSHIP OF THE PARTIES	94

29.	ENTIRE AGREEMENT AND SEVERABILITY	94

30.	ENGLISH LANGUAGE	95

31.	AMENDMENT	95

32.	WAIVER AND NON-EXCLUSION OF REMEDIES	95

33.	NO BENEFIT TO THIRD PARTIES	96

34.	FURTHER ASSURANCE	96

35.	EXPENSES	96

36.	COUNTERPARTS	96

SCHEDULE 1		98

SCHEDULE 2		115

SCHEDULE 3		117

SCHEDULE 4		118

SCHEDULE 5		121

SCHEDULE 6		129

THIS PRODUCT COMMERCIALISATION AND SUPPLY CONSOLIDATED AGREEMENT is made the 6th day of June 2006

BETWEEN:

(1) GW PHARMA LIMITED a company incorporated in England & Wales (Company No. 3704998) whose principal place of business is Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ, United Kingdom (“ GW Pharma ”) a wholly owned subsidiary of GW Pharmaceuticals plc; and

(2) ALMIRALL PRODESFARMA, S.A. a company incorporated in Spain whose principal place of business is General Mitre 151, 08022 Barcelona, Spain (“ Almirall ”).

WHEREAS:

(A) GW Pharma is engaged in, among other things, the research, development, manufacture and commercialisation of drug products in Europe and elsewhere in the world.

(B) Almirall is engaged in, among other things, the development and commercialisation of drug products in the Territory (as hereafter defined).

(C) GW Pharma is the owner of certain intellectual property and related rights covering the Product (as hereafter defined).

(D) GW Pharma is in the process of completing the development of the Product in the Territory.

(E) Upon completion of such development, Almirall wishes to commercialise the Product in the Territory.

(F) Based on the foregoing, GW Pharma has granted to Almirall an exclusive right in the Territory to Commercialise (as hereafter defined) Product in the Territory and has agreed to supply Almirall with its requirements of Product for this purpose and Almirall has acquired such right to Commercialise and buy such Product upon the terms and conditions of the Collaboration and Supply Agreement dated December 9 th , 2005 (“the Initial Agreement”).

(G) Subsequently, GW Pharma and Almirall have entered into certain discussions on the scope of some terms of the Initial Agreement and the manner to interpret and implement them. This has given rise to lengthy discussions and exchange of correspondence to clarify all the issues and to reach a common interpretation.

(H) Now, GW Pharma and Almirall wish to concrete their common understanding of their relationships with regards to the Commercialisation and Supply of the Product in this Consolidated Agreement that shall constitute the entire agreement between them, superseding all prior contracts or agreements whether written or oral.

IT IS NOW AGREED AS FOLLOWS:

1. DEFINITIONS

1.1 In this Agreement the following definitions shall apply unless the context requires otherwise:-

“Affiliate” — any company, partnership or other business entity which controls, is controlled by or is under common control with either Party. For the purposes of this definition only, “control” refers to any of the following (a) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through ownership of voting securities, by contract or otherwise; (b) ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or of fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; (c) status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.

“Agreement” - this document including any and all schedules, appendices and other addenda to it as may be added and/or amended from time to time in accordance with the provisions of this document.

“Almirall IP” —Almirall Know How and Almirall Materials.

“Almirall Know How” — Know How generated and Controlled by Almirall or its Affiliates under this Agreement from its own activity that is necessary for and directly relates to the Commercialisation of Product, including all Know How generated from Marketing Studies.

“Almirall Materials” - Materials becoming controlled by Almirall or its Affiliates under this Agreement that are necessary for and relate exclusively to the Commercialisation of Product.

“ Allocable Overhead ” - an amount added to an item of cost to reflect central or other overhead incurred by a Party or for its account including overhead attributable to the operation by it of its information systems, human relations, payroll, purchasing, supervisory and other internal groups together with its occupancy costs any of which it normally allocates to its departments or project groups based on space occupied or headcount or other activity-based method consistently applied.

“Applicable Laws” - all applicable laws, rules, regulations, directives and associated guidelines (including any amendments, extensions or replacements thereto) (i) in the Territory that apply to the Development or Commercialisation of the Product in the Territory; and (ii) in or outside the Territory that apply to the performance of either Party’s obligations under this Agreement.

“Botanical Drug Substance ” — THC Botanical Drug Substance and/or CBD Botanical Drug Substance, as the context requires.

“Brand Team” — has the meaning given to it in Clause 3.7.

“Business Day” - 9.00am to 5.00pm local time on a day other than a Saturday, Sunday or bank or other public holiday in the United Kingdom or Spain.

“Calendar Year” — the period commencing 1 January and ending 31 December in any one year.

“ CBD Botanical Drug Substance ” — *** extract of a *** characterised cannabis plant, containing ***.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“Certificate of Analysis” - a document of that name as described in detail in the current Guide to Good Manufacturing Practice for Medicinal Products published by the European Commission.

“Change of Control” — with respect to either Party, any of the following events: (i) a merger or consolidation of any of the Parties which results in the voting securities of such Party outstanding immediately prior thereto ceasing to represent at least fifty percent (50%) of the combined voting power of the surviving entity immediately after such merger or consolidation, (ii) a Third Party becoming, directly or indirectly, the beneficial owner of fifty percent (50%) or more of the combined voting power of the outstanding securities of such Party or otherwise designating more than fifty percent (50%) of such Party board of directors or (iii) the sale or other transfer to a Third Party of all or substantially all of the Party’s assets which relate to this Agreement.

“Clinical Trial” — any of a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial carried out with regard to Product by GW Pharma in order to obtain a Marketing Authorisation in the Territory or a Phase IV Clinical Trial carried out with regard to Product by GW Pharma at the request of a Regulatory Authority or addressed to change the Labelling for Product or to maintain a Marketing Authorisation.

“CMC Data” - that part of an CTA, MAA or Regulatory Approval containing the data and other know how relating to the chemistry and manufacturing controls and other manufacturing processes for the Product, including relating to the Packaging and Labelling.

“Commercialisation”, “Commercialising”, or “Commercialise” — all activities relating to the import, advertising, promotion and other marketing, pricing and reimbursement, Detailing, distribution, storage, handling, offering for sale and selling, customer service and support, for the Product in the Territory.

“Commercialisation Plan” — the plan for the Commercialisation of the Product in the Territory (including Marketing Studies) to be generated by Almirall under the provisions of Clause 5.2.

“Commercially Reasonable Efforts” — (i) in respect of Almirall means efforts and resources commonly used by pharmaceutical companies of a similar size to Almirall based on annual sales revenue to Commercialise a product owned by such a company or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential to the Product and taking into account the patent and other proprietary position of the product, or (ii) in respect of GW Pharma means efforts and resources commonly used by pharmaceutical companies of a similar size to GW Pharma based on funds raised to Develop a product owned by such a company or to which it has rights, which product is at a similar stage in its development or product life and is of similar market potential to the Product and taking into account the patent and other proprietary position of the product.

“Competent Authority” - any national or local agency, authority, department, inspectorate, minister, ministry official, parliament or public or statutory person (whether autonomous or not) of any government of any country having jurisdiction over either any of the activities contemplated by this Agreement or over the Parties.

“Confidential Information” — any Know How disclosed either directly or indirectly by one of the Parties hereto to the other and pertinent to the subject matter of this Agreement. In the case of obligations on GW Pharma in relation to Confidential Information shall mean Almirall Know How, in the case of obligations on Almirall in relation to Confidential Information shall mean GW Pharma Know How and in the case of GW Pharma and Almirall shall mean trade secrets and confidential information relating to Product, or the business affairs or finances or any other sensitive information of the other Party, supplied or otherwise made available to them or coming into their possession in relation to the performance of this Agreement.

“Control” - with respect to any Know How, Patent Rights or Trade Mark, possession of the right, whether directly or indirectly, and whether by ownership, licence or otherwise, to assign, or grant any rights to or under, such Know How, Patent Right or Trade Mark as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

“ Cost of Manufacture ” - the direct cost of manufacture of Product, being direct labour and material costs and quality assurance/control costs (excluding Allocable Overhead) incurred by GW Pharma in manufacturing Product and, where

manufacture or part thereof is contracted to a Third Party, any charge rendered by that Third Party for manufacture of Product.

“Cover” (including the variations such as “Covered” , “Coverage” or “Covering” ) - making, using or Commercialisation of a given product in a Commercialised form would infringe a Valid Claim of a Patent Right in the absence of a licence under such Patent Right. The determination of whether a product is so covered by a particular Patent Right shall be made on a country-by-country basis.

“CTA” — Clinical Trial Application filed with the Regulatory Authority of a country in the Territory prior to beginning trials in humans in that country.

“Data Package” — has the meaning set out in Clause 6.2.

“Detail” (including such variations as “Detailing” ) - face to face contact between a field sales force representative and a medical professional with prescribing authority for the purpose of discussing scientific or medical information about a pharmaceutical product(s).

“ Detailing Commitment ” — the Detailing effort to be effected by Almirall, on a country by country basis *** in the *** year period between Launch in each such country and *** months thereafter to be agreed by the Parties through the medium of the JSC by (a) 31 December 2006 or (b) twelve (12) months prior to anticipated Launch in each EU6 Country, whichever is the later.

“Development” — all pre-Marketing Authorisation development and regulatory activities regarding the Product in the Territory to be conducted with the aim of obtaining Marketing Authorisation for the Product for any Indication.

“ Development Costs ” — the costs and expenses associated with Development activities of GW Pharma which shall include, but are not limited to, costs of studies on the toxicological, pharmacological, metabolical or clinical aspects of a Product considered internally or by individual investigators or consultants and necessary or

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

desirable for the purpose of obtaining, maintaining and/or expanding Marketing Authorisation of Product, the manufacture of clinical supplies of Product, costs for preparing, submitting, reviewing or developing data or information for the purpose of submission to a Regulatory Authority to obtain, maintain and/or expand Marketing Authorisation of Product. Development Costs shall also include expenses for data, management, statistical designs and studies, documents preparation and other administration expenses associated with the Clinical Trials program. Such costs and expenses to be supported by evidence in Document form. For clarity such costs and expenses do not include the cost of manufacture (including active pharmaceutical ingredient manufacture) including development of manufacturing processes, save that Development Costs shall include pharmaceutical development and pilot plant batches *** for New Indications and Follow-On Products.

“Development Plan” - the detailed program for Development of Product in the Territory with the aim of obtaining Marketing Authorisation for Product for various Indication(s) including key timelines therefor, an initial form of which covering the Development of the Principal Indications has been agreed and is set out in Schedule 1 (“Agreed Development Plan”) and which may be amended from time to time by JSC under the provisions of Clause 3.2.

“Development Team” - has the meaning given to it in Clause 3.4.

“Disclosing Party” - the Party which discloses Confidential Information to the other Party.

“ Distributor” — an entity appointed by Almirall to Commercialise Product in a specific country or countries in the Territory other than an EU6 Country.

“Documents” — analyses, books, CD-ROM, charts, comments, computations, designs, discs, diskettes, files, graphs, ledgers, notebooks, paper, photographs, plans, records, recordings, reports, research notes, tapes and any other graphic or written data or other media on which Know How is permanently stored and other computer

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

information storage means, and advertising and promotional materials of any nature whatsoever including preparatory materials for the same.

“Effective Date” — the date of execution of the Initial Agreement.

“ EU6 Countries ” — the Major European Markets plus Belgium and Portugal.

“ex-EU Partner” — the Third Party or Third Parties (if any) to whom GW Pharma may grant the right to commercialise the Product so that that person may Commercialise the Product outside the Territory.

“Final Report” - the formal written report in relation to a Clinical Trial setting out a final assessment of the results and conclusion of such Clinical Trial.

“Follow-On Products” — a formulation improvement to the Product.

“Forecasts” — has the meaning given to it in Clause 10.1.

“Force Majeure” - in relation to either Party, any event or circumstance which is beyond the reasonable control of that Party which event or circumstance that Party could not reasonably be expected to have taken into account at the date of this Agreement and which results in or causes the failure of that Party to perform any or all of its obligations under this Agreement, including acts of God, lightning, fire, storm, flood, earthquake, accumulation of snow or ice, lack of water arising from weather or environmental problems, strike, lockout or other industrial or student disturbance, act of the public enemy, war declared or undeclared, threat of war, terrorist act, blockade, revolution, riot, insurrection, civil commotion, public demonstration, sabotage, act of vandalism, prevention from or hindrance in obtaining in any way materials, energy or other supplies, explosion, fault or failure of plant or machinery (which could not have been prevented by Good Industry Practice), or Legal Requirement governing either Party, provided that lack of funds shall not be interpreted as a cause beyond the reasonable control of that Party.

“Fully Burdened Cost of Manufacture” — GW Pharma’s fully burdened manufacturing cost, which shall comprise:

(a) the direct cost of manufacturing Product limited to *** and *** and ***control costs including ***, as determined by GW Pharma in accordance with IFRS accounting principles consistently applied; or

(b) in the case where manufacture is contracted to a Third Party, any charge rendered by that Third Party for the manufacture of Product; and

(c) any other costs borne by GW Pharma for transportation, insurance and customs clearance and storage of Product at the request of Almirall.

“ Generic Competitive Product ” - any product that contains *** and *** in combination for which *** has been demonstrated to the satisfaction of the relevant Regulatory Authorities and which can be substituted for Product by ***, which product has a *** in the country in question for use in any of the *** in question.

“Good Clinical Practice” or “GCP” - clinical practice as set out in:

(a) Directive 2001/20/EC, Directive 2001/83/EC and Directive 2005/28/EC as well as ICH-GCP and any other guidelines for good clinical practice for trials on herbal medicinal products in the European Community as amended and applicable from time to time; and

(b) the Declaration of Helsinki as last amended at the 52nd World Medical Association in October 2000 and any further amendments thereto.

“Good Industry Practice” — in relation to any undertaking and any circumstance, the exercise of that degree of skill diligence, prudence and foresight which would reasonably and ordinarily be expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances.

“Good Laboratory Practice” or “GLP” - laboratory practice as set out in Directive 2004/9/EC and Directive 2004/10/EC, as may be amended or replaced from time to

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

time as well as any “Rules Governing Medicinal Products in the European Community Vol III, ISBN 92.825 9619-2 (ex OECD principles of GLP) as amended and applicable from time to time.

“Good Manufacturing Practice” or “GMP” - manufacture of herbal medicinal products in accordance with Directive 91/812/EEC and Directive 2003/94/EC or any other applicable European Community legislation or regulation as amended and applicable from time to time.

“GW Pharma IP” - the GW Pharma Patent Rights, GW Pharma Know How, GW Pharma Plant Variety Rights and the Trademark.

“GW Pharma Know How” - Know How Controlled by GW Pharma or its Affiliates at the Effective Date or during the period of this Agreement which relates to Product and which is necessary for GW Pharma to Develop the Products that Almirall under its obligations hereunder, will Commercialise by exercising the rights and obligations granted to it hereunder in the Territory.

“GW Pharma Patent Rights” - the Patent Rights Covering the Product set out in Schedule 2 and all other Patent Rights which become Controlled by GW Pharma, or its Affiliates during this Agreement which Cover the Product and are necessary for Almirall to undertake its obligations hereunder and to exercise the rights and obligations of Commercialisation granted to it hereunder in the Territory.

“GW Pharma Plant Variety Rights” — the plant variety rights set out in Schedule 6 and any other right granted to GW Pharma by the Community Plant Variety Office or a national plant variety right office in the Territory under The International Convention for the Protection of New Varieties of Plants (the UPOV convention) and relating directly to Product.

“GW Sales Income” — the income due to GW based on sales made by Almirall on a country by country basis calculated by multiplying the Supply Price for the country in question by the number of Units sold in that country in the relevant Calendar Year.

“ICH-GCP” — means the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95).

“IFRS” — International Financial Reporting Standards established by the International Accounting Standards Board, as amended from time to time.

“Indemnification Claim Notice” — has the meaning set out in Clause 19.3.

“Indication” — a Principal Indication or a New Indication.

“Initial Period” — the period of *** months following Launch in ***.

“Insolvency Event” - in relation to:

(i) GW Pharma, means any one of the following:

(a) a notice shall have been issued to convene a meeting for the purpose of passing a resolution to wind up GW Pharma, or such a resolution shall have been passed other than a resolution for the solvent reconstruction or reorganisation of GW Pharma; or

(b) a resolution shall have been passed by GW Pharma’s directors to seek a winding up or a petition for a winding up shall have been presented against GW Pharma which, in the case of a petition presented against GW Pharma, shall not have been appealed within seven (7) days of having been lodged or such an order shall have been made and shall have been dismissed within thirty (30) days thereafter; or

(c) a receiver, administrative receiver, receiver and manager, interim receiver, custodian, sequestrator or similar officer is appointed in respect of GW Pharma or an encumbrancer takes steps to enforce or enforces its security which shall not have been dismissed by a court of competent jurisdiction within thirty (30) days thereafter; or

(d) (i) a resolution shall have been passed by GW Pharma or GW Pharma’s directors to make an application for an administration order or to appoint an administrator, or (ii) an application for an

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

administration order shall have been made to the court or a notice of appointment of an administrator shall have been filed at the court in respect of GW Pharma, which in the case of such an application made to the court or notice filed with the court, shall not have been appealed within seven (7) days of having been made or filed or such an order or appointment shall have been dismissed within thirty (30) days thereafter; or

(e) a proposal for a voluntary arrangement shall have been made in relation to GW Pharma under Part I Insolvency Act 1986; or

(f) where GW Pharma, as a company resident in the United Kingdom, is deemed to be unable to pay its debts within the meaning of Section 123 Insolvency Act 1986; and

(ii) Almirall means a step or event shall have been taken or arisen outside the United Kingdom which is similar or analogous to any of the steps or events listed at (a) to (f) above under the Spanish Commercial Code and Ley 22/2003 Concursal or other relevant laws of Spain which, in the case of a filing made against Almirall, shall not have been appealed within twenty (20) days of having been lodged or such an order shall have been made and dismissed within thirty (30) days thereafter.

“Invoice Income” — has the meaning given to it in Clause 11.2.

“Invoice Price” — has the meaning given to it in Clause 11.2.

“Joint Steering Committee” or “JSC” — has the meaning given to it in Clause 3.

“Know How” - technical and other information which is not in the public domain, including information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), processes (including manufacturing processes, specifications and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports, manufacturing data or summaries and

information contained in submissions to and information from ethical committees and regulatory authorities. Know How includes Documents containing Know How, including but not limited to any rights including trade secrets, copyright, database or design rights protecting such Know How. The fact that an item is known to the public shall not be taken to preclude the possibility that a compilation including the item, and/or a development relating to the item, is not known to the public.

“ Label ” , “ Labelled ” or “ Labelling ” - all labels and other written, printed or graphic matter upon (i) the Product or any container or wrapper utilized with the Product, or (ii) any written material accompanying the Product, including, without limitation, package inserts and patient information leaflet.

“Launch” - the first invoiced commercial sale by Almirall, its Affiliates or distributors in the Territory of Product after grant of the required Marketing Authorisation to Commercialise Product.

“Launch Commitment” — on a country by country basis the amount of costs and expenses to be incurred in the *** year period between Launch in each EU6 Country and *** months thereafter by Almirall, directly or indirectly, in relation to (i) educational promotional activities; (ii) advertising the Product in each EU6 Country; (iii) marketing, selling and promoting the Product in each EU6 Country; and (iv) public relations in relation to Product in each EU6 Country, to be agreed by the Parties through the medium of the JSC by (a) 31 December 2006 or (b) twelve (12) months prior to anticipated Launch in each of the EU6 Countries, whichever is the later.

“Legal Requirement” - any present or future law, regulation, directive, instruction, direction or rule of any Competent Authority or Regulatory Authority including any amendment, extension or replacement thereof which is from time to time in force.

“Lifecycle Management Plan” — any plans for:

(i) Phase IV Clinical Trials;

(ii) Development of Product in the Territory for New Indications; and

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(iii) Development of Follow-On Products in the Territory.

“List Price” — the price for a Unit of Product in a country published by Almirall in a given Calendar Year prior to any discount being given.

“Losses” - any and all liabilities, damages, losses and expenses, (including reasonable lawyers’ fees and disbursements). In calculating “Losses”, the duty to mitigate on the part of the Party suffering the Losses shall be taken into account.

“Marketing Authorisation Application” or “MAA” — an application filed by GW Pharma with a Regulatory Authority to obtain Marketing Authorisation for Product in the Territory, or any comparable application filed with the Regulatory Authority in or for a country or group of countries outside the Territory to obtain Marketing Authorisation for Product in or for that country or within that group of countries.

“Manufacturing Authorisation” - any approval required from a Regulatory Authority to manufacture, assemble, test, store, distribute, import and wholesale deal the Product.

“Major European Markets” - France, Germany, Italy and Spain.

“Marketing Authorisation” - any approval required from a Regulatory Authority to market and sell Product in any country in the Territory excluding, where necessary to market and sell Product in a specific country in the Territory, any form of pricing or reimbursement approval.

“Marketing Study” - any clinical study on Product which is not a Clinical Trial, which shall be carried out by or on behalf of Almirall, being, any study which the JSC agrees is being carried out with a commercial objective and the results of which are intended to be used for marketing purposes.

“Materials” — any Documents relating to Development or Commercialisation.

“Net Sales” - the gross amounts received by Almirall its Affiliates or distributors for all sales of Product less the following items to the extent that they are paid or actually allowed and are shown on the relevant invoice or other evidence in Document form:

(a) quantity, trade and/or cash discounts actually granted for such Product;

(b) amounts repaid or credited and other allowances (including cash, credit or free goods allowances), given by reason of rebates (including government-mandated rebates) or retroactive price reductions or billing errors for such Product;

(d) freight, shipment and insurance costs incurred transporting Product to a third party purchaser;

(e) taxes, tariffs, customs duties and surcharges and other governmental charges; and

(f) any other governmental contributions required to be made by Almirall in relation to sales of Product pursuant to a signed agreement between the Spanish pharmaceutical industry and the Spanish government and for which Almirall confirms that it receives no benefit in kind from the Spanish government in the form of a tax rebate or the like with respect to this contribution.

The transfer of Product by Almirall or one of its Affiliates to another Affiliate shall not be considered a sale. In such cases Net Sales shall be determined based on the invoiced sale price by the Affiliate to the first third party trade purchaser, less the deductions allowed under this Clause.

Upon the sale or other disposal of Product other than in a transaction generating revenues from or based on a sales price for the Product which sales price is either customary or would be reasonably expected in the country of sale, such sale, disposal or use shall be deemed to constitute a sale with the consideration for the sale being the consideration for the relevant transaction and constituting Net Sales hereunder or if the consideration is not a monetary amount a sale shall be deemed to have occurred for a price assessed on the value of whatever consideration has been provided in exchange for the supply. Disposal of Product for or use of Product in, Marketing Studies or as free samples shall not give rise to any deemed sale under this Section. For clarity, there shall be no limit on the quantity of Product which may be used in

Clinical Trials but the quantity of Product to be given away as free samples shall be such quantities common in the industry for this sort of Product, which shall in any event not exceed ***.

Such amounts shall be determined from the books and records of Almirall maintained in accordance with IFRS, consistently applied.

“Net Selling Price” — price for a Unit of Product calculated on the basis of total Net Sales of all Product in a Calendar Year divided by the number of Units of Product sold in that Calendar Year save that where Product is sold otherwise than on arm’s length terms. The quantity of Product sold or disposed of and the terms on which such Product is sold or disposed of shall be excluded from the calculation of Net Selling Price. The Net Selling Price shall be calculated on a country by country basis with each country having its own Net Selling Price.

“New Indication” - any indication other than a Principal Indication.

“ Package ”, “ Packaged ” and “ Packaging ” - all primary and secondary packaging components, including, without limitation, cartons, partitions, shippers, or any other like matter used in packaging the Product.

“Party or Parties” — GW Pharma and/or Almirall.

“Patent Rights” - patent applications and patents, utility certificates, improvement patents and models and certificates of addition and all foreign counterparts of them in all countries, including any divisional applications and patents, refilings, renewals, re-examinations, continuations, continuations-in-part, patents of addition, extensions, (including patent term extensions,) reissues, substitutions, confirmations, registrations, revalidations, pipeline and administrative protections and additions, and any equivalents of the foregoing in any and all countries of or to any of them, as well as any supplementary protection certificates and equivalent protection rights in respect of any of them.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“Pharmacovigilance Agreement” — the agreement to be made between GW Pharma and Almirall as specified in Clause 12.1 concerning safety and pharmacovigilance matters.

“Phase I Clinical Trial” - human clinical trial to establish the safety and suitability of a product for further clinical trials.

“Phase II Clinical Trial” — human clinical trial where a product is tested in a limited number of patients for the purpose of establishing dose ranging and/or further indication of efficacy of Product.

“Phase IIa Clinical Trial” - human clinical trial where Product is tested in a limited number of patients for the purpose of establishing a first indication of efficacy of Product a New Indication.

“Phase II POC Clinical Trial” — human clinical trial where a product is tested in a limited number of patients for the purpose of establishing dose ranging and/or further indication of efficacy of Product for a New Indication.

“Phase III Clinical Trial” - a large scale, pivotal, multi-centre, human clinical trial to be conducted in a number of patients estimated to be sufficient to primarily establish efficacy of a Product in the medical indication being investigated and at a standard suitable to obtain Marketing Authorisation in the Territory (excluding dose ranging studies).

“Phase IV Clinical Trial” — any post Marketing Authorisation clinical trial required to be carried out by a Regulatory Authority or any clinical trial addressed to change the Labelling of Product or to maintain a Marketing Authorisation.

“Pivotal Trial” — a Phase III Clinical Trial or such other Clinical Trial the data from which is the basis for an MAA.

“Presentation” — finished, Labelled and Packaged Product.

“Principal Indications” — the three (3) indications which the Parties have agreed will be Developed under the Development Plan, namely:

(a) relief of spasticity and neuropathic pain associated with multiple sclerosis;

(b) relief of neuropathic pain (peripheral and general); and

“Product” — (i) the pharmaceutical product for human therapeutic use, a description of which is set out in Schedule 3 finished, Packaged and Labelled either for use in Clinical Trials, Marketing Studies or in a form being used for Commercialisation, (ii) any Follow-on product; and (iii) any other product developed by GW Pharma containing only a combination of *** and *** in which the ratio of ***:*** is between *** and ***.

“Program Budget” — the budget for Program Costs in relation to performance of the Lifecycle Management Plan. The Program Budget for each year of the Lifecycle Management Plan will be set by the JSC under Clause 3.2.2. The Program Budget for any year may be agreed and amended from time by the JSC under Clause 3.2.2.

“Program Costs” - the costs to be incurred in carrying out the Lifecycle Management Plan.

“Projected Sales” — the forecast sales of Product to be made by Almirall its Affiliates or Distributors to Third Parties in each country in the Territory in any Calendar Year or part thereof commencing on the second anniversary of Launch, which number is to be agreed between Parties at the JSC under Clause 3.2.8.

“Quarter” - each period of three months ending on 31 March, 30 June, 30 September or 31 December and “Quarterly” shall be construed accordingly.

“Recall Costs” — has the meaning set out in Clause 10.21.

“Recipient Party” - the Party which receives Confidential Information from the other Party.

“Regulatory Authority” - any national, supranational, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in any country in the Territory involved in the granting of Marketing Authorisation.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“Significant Event” - a new material event occurring in a country in the Territory as a result of external factors outside of Almirall’s control, which either (i) has a significant impact on the market opportunity for the Product in a specific country in the Territory, or (ii) which limits or excludes Almirall’s ability to Commercialise Product in a specific country in the Territory, unforeseeable at the time the Projected Sales for a year are set and for which Almirall can provide Tangible Evidence. Examples of what may be considered a Significant Event include the following: changes in reimbursement, launch of competitive products, launch of Generic Competitive Product, changes in health policy of a country in the Territory regarding or affecting the Product, so long as such Significant Event is new, material and unforeseeable at the time the Projected Sales for a Calendar Year are set.

“Specifications” - the specifications for Product set forth in the Marketing Authorisation for each country in the Territory.

“Successful Completion of Phase III Clinical Trial” - presentation of the Final Report for the first Phase III Clinical Trial which shows that such clinical trial has successfully met its primary end point set out in the clinical trial protocol for that clinical trial meaning for clarity that such clinical trial has shown a statistically significant difference compared with placebo.

“Supply Price” — the price per Unit (calculated on a country by country basis) at which GW Pharma will supply Almirall with Product being (i) *** per cent (***%) of the Net Selling Price, and (ii) *** per cent (***%) of the Net Selling Price. For the avoidance of doubt the increase to the rate of *** per cent (***%) of the Net Selling Price applies from the end of the Initial Period.

“Tangible Evidence” - evidence in the form of Documents of any Significant Event.

“Technical Agreement” - the agreement to be made between GW Pharma and Almirall specified in Clause 9.6 concerning such technical matters as may reasonably be required by the Parties and in accordance with the applicable Regulatory Authorities in connection with the supply and release of the Product in the Territory.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“Term” — has the meaning set out in Clause 20.1.

“Territory” — Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Macedonia, Monaco, Norway, Poland, Portugal, Romania, San Marino, Serbia and Montenegro, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, Turkey and the Vatican City. For clarity the Territory does not include Great Britain, Northern Ireland, the Channel Islands or the Isle of Man.

“ THC Botanical Drug Substance ” — liquid carbon dioxide extract of a chemically and genetically characterised cannabis plant, containing delta-9-tetrahydrocannabinol as the principal cannabinoid.

“Third Party” — a party other than either of the Parties or any of their respective Affiliates.

“Trademark” - the trademarks and/or trade names that are Controlled by GW Pharma or its Affiliates set out in Schedule 4 for use by Almirall, as distributor and Commercialising contractor, in connection with the Commercialisation of the Product by in the Territory (provided that such trademark or trade name is approved by the Regulatory Authority in the Territory) or any other trade mark or trade name the subject of Clause 14.

“Trade Dress” - those aspects of the Packaging of the Product involving the design, get up and trade dress thereof which are not required or dictated by the Marketing Authorisation in the Territory, including the style of printing.

“Unit” — one vial of Product of such size as GW Pharma may manufacture from time to time according to a specific Marketing Authorisation.

“Valid Claim” — either:

(a) a claim of an issued and unexpired patent included within Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a

decision of a court or other governmental agency of competent jurisdiction, unappealable or un-appealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or

(b) a claim of a pending patent application included within Patent Rights which claim was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of the application, provided that no more than ten (10) years have passed since the earliest priority date for such application.

1.2 In this Agreement:

1.2.1 unless the context otherwise requires all references to a particular Clause, paragraph or Schedule shall be a reference to that Clause, paragraph or Schedule, in or to this Agreement as it may be amended from time to time pursuant to this Agreement;

1.2.2 the table of contents and headings are inserted for convenience only and shall not affect the interpretation of any provision of this Agreement;

1.2.3 unless the contrary intention appears words importing the masculine gender shall include the feminine and vice versa and words in the singular include the plural and vice versa;

1.2.4 unless the contrary intention appears words denoting persons shall include any individual, partnership, company, corporation, joint venture, trust, association, organisation or other entity, in each case whether or not having separate legal personality;

1.2.5 reference to the words “include” or “including” are to be construed without the limitation to the generality of the preceding words; and

1.2.6 reference to any statute or regulation includes any modification or re-enactment that statute or regulation.

2. PRINCIPAL RIGHTS

2.1 GW Pharma hereby grants to Almirall an exclusive right, under GW Pharma IP and Trademark, to Commercialise and distribute, and have Commercialised and

distributed Products in the Territory but always subject to the other provisions of this Agreement. In addition to that, GW Pharma hereby grants to Almirall an exclusive right to make, have made, use, have used, the Products in the Territory but always subject to the other provisions of this Agreement, and in particular, Almirall shall not exercise its right of manufacture save as permitted under Clause 21.2. For the avoidance of doubt it is declared and agreed that the granting of this right is non transferable and may not be granted to any other Third Party although nothing herein restricts the ability of Almirall to appoint Distributors or to sub-contract any of its obligations hereunder in the ordinary course of business. Almirall shall not acquire or have any right or license to the CMC Data, GW Pharma’s clinical data or under any Marketing Authorisation.

2.2 Almirall hereby grants to GW Pharma an exclusive, sub-licensable licence under Almirall IP, solely to make, have made, use, have used, Commercialise and have Commercialised Products outside the Territory but always subject to the other provisions of this Agreement, including Clause 6.2.

3. MANAGEMENT OF THE RELATIONSHIP

Joint Steering Committee

3.1 With effect from the Effective Date the Parties shall establish and run a Joint Steering Committee (“JSC”) to (i) manage and oversee the Development Plan and the Lifecycle Management Plan and all regulatory activity in the Territory and (ii) to manage and oversee Commercialisation of Product in the Territory, as follows:

3.1.1 The JSC shall comprise eight (8) persons (“Members”) and GW Pharma and Almirall respectively shall be entitled to appoint four (4) Members, to remove any Member appointed by it and to appoint any person to fill a vacancy arising from the removal or retirement of such Member appointed by it;

3.1.2 Almirall and GW Pharma respectively shall each notify the other of any change in the identities of their Members. Both sides shall use reasonable efforts to keep an appropriate level of continuity in representation. Members may be represented at any meeting by another person designated by the absent Member. The JSC shall have a Chairperson, the Chair will alternate between the Parties from JSC meeting to JSC meeting;

3.1.3 Conclusions and decisions of the JSC shall be made by unanimous agreement of the Members wherever possible with each Party having a single vote irrespective of the number of Members from each Party actually in attendance and such conclusions and decisions shall be minuted by or on behalf of the Chairperson who shall send a copy of the minutes of each JSC meeting to both Parties. Both Parties will use their reasonable efforts to build consensus. The JSC Members shall at all times when making a decision consider in good faith and make decisions consistent with:

(i) developing Product, obtaining Marketing Authorisation for the Product for the Principal Indications in the Territory and lifecycle management; and

(ii) commercialising the Product in the Territory.

If the JSC does not reach unanimous agreement on any particular matter then such matters requiring resolution shall be referred to the Chief Executive Officer of GW Pharma or equivalent position or his or her nominee and the Chief Executive Officer of Almirall or equivalent position or his or her nominee for resolution, who together shall use reasonable and good faith efforts to resolve such matters within thirty (30) days of the date such matters are referred to them for resolution. If the Parties still fail to resolve the matter so referred to the Chief Executive Officers or equivalent position of Almirall and GW Pharma then, save as set out below, the matter shall remain undecided and the Parties shall continue with this Agreement (including the Development Plan, Lifecycle Management Plan and Commercialisation Plan) without change. Both Parties shall make Commercially Reasonable Efforts to agree on such undecided matters. Notwithstanding the foregoing if the Chief Executive Officers or equivalent position of Almirall and GW Pharma cannot resolve a matter referred to them relating to (a) GW Pharma’s responsibilities as Marketing Authorisations holder, or (b) decisions relating to changes to the Specification or manufacture of the Product and the implementation of any improvements thereto, the final decision shall be that of GW Pharma’s Board of Directors, which shall be exercised in good faith. If such persons cannot resolve a matter related to Almirall’s contribution to Program Costs

for the Development of Follow-On-Products or a New Indication or Marketing Studies the final decision shall be that of Almirall’s Board of Directors, which shall be exercised in good faith, save that once Almirall has committed to a specified element of the Program Budget Almirall cannot use this right to amend the Program Costs to which it has committed. Any such agreement or resolution in this way shall for the purposes of this Agreement constitute a unanimous vote of the JSC. For clarity all decisions relating to quantities of Product to be ordered under Clause 9.2 shall require the agreement of both Parties’ JSC Members. All decisions regarding the appointment of Distributors shall be Almirall’s subject to GW Pharma’s approval in accordance with Clause 5.10.2;

3.1.4 Unless otherwise agreed, the venue for meetings shall alternate between the premises of the Parties, if not held by teleconference or videoconference. Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with JSC meetings;

3.1.5 The JSC shall have power to invite persons whose special skills or influence might advance the Development Plan and Lifecycle Management Plan or Commercialisation of Product, in confidence and upon behalf of the JSC, to attend and address meetings of the JSC. For the avoidance of doubt it is agreed that such persons shall not be Members and shall not participate in the decision making process of the JSC;

3.1.6 The JSC Chairperson is responsible for promptly preparing the minutes of any JSC meeting and in any event shall do so within ten (10) Business Days thereof, seeking unanimous approval of those minutes from the JSC Members, signing and dating the approved minutes and promptly distributing a copy of the signed minutes to each Party. It is only such signed and dated minutes which shall constitute a decision of the JSC.

3.2 The JSC:

3.2.1 shall hold meetings in person as frequently as the members of the JSC may agree shall be necessary and otherwise by teleconference or a video-conference but in any event no less frequently than four times a Calendar Year, with the first such meeting occurring not later than 31 March and the

third such meeting not later than 31 October in such Calendar Year. Dates of meetings shall be agreed by the Parties not less than thirty (30) days beforehand; responsibility for arranging the meetings, including, at least, providing notice and an agenda, shall be the responsibility of the Chairperson for that meeting; the first meeting of the JSC will take place as soon as practicable after the Effective Date and will be organised by GW Pharma;

3.2.2 shall by 31 October in each Calendar Year discuss and determine the Development Plan including the Lifecycle Management Plan as appropriate for the following Calendar Year based on the proposals of the Development Team and including any necessary change from the previous Calendar Year (if any) and the Program Budget therefor and each Party’s responsibilities for Program Costs thereunder. The Lifecycle Management Plan shall contain reasonable target dates for major events as appropriate, and the JSC shall discuss these in good faith with reference to progress made in the current Calendar Year. The JSC may add to and/or amend each Development Plan and Lifecycle Management Plan and Program Budget during the course of any Calendar Year as it considers appropriate from time to time, as long as each amendment is reduced to writing and signed and dated in accordance with the decision making process described in Clause 3.1.3 above. The JSC shall retain copies of all such authorised versions of the Development Plan and Lifecycle Management Plan and each shall become incorporated in this Agreement as of the date of signature by the JSC Chairperson;

3.2.3 shall by 31 October in each Calendar Year review the proposed Commercialisation Plan for the following Calendar Year proposed by the Brand Team. The JSC may, at the request of the Brand Team only, add to and/or amend each Commercialisation Plan during the course of any Calendar Year as it considers appropriate from time to time, as long as each amendment is reduced to writing and signed and dated in accordance with the decision making process described in Clause 3.1.3 above. The JSC shall retain copies of all such authorised versions of the Commercialisation Plan and each shall become incorporated in this Agreement as of the date of signature by the JSC Chairperson;

3.2.4 shall consider the desirability of the Development and Commercialisation of Follow-On Products. If the Parties decide that any such Follow-On Product is desirable the JSC shall seek to agree the Development responsibility of GW Pharma, the Program Costs therefor to be paid by Almirall and once agreed the Lifecycle Management Plan shall include the plan for such Follow-On Product;

3.2.5 shall be a co-ordination forum in relation to the global issues relating to Product Commercialisation;

3.2.6 shall discuss Trademark issues pursuant to Clause 14, if required to do so;

3.2.7 shall review the sales reports filed with it by Almirall under Clause 5.10.7;

3.2.8 shall determine the Projected Sales for each country in the Territory in each relevant Calendar Year. If the Parties cannot reach unanimous agreement on the Projected Sales for a country in a particular Calendar Year following referral to the Chief Executive Officer of GW Pharma or equivalent position or his or her nominee and the Chief Executive Officer of Almirall or equivalent position or his or her nominee for resolution then Projected Sales for such country for such Calendar Year shall be set as follows:

(i) if the Projected Sales for an EU6 Country cannot be agreed for the first Calendar Year commencing *** months after Launch in that country, such Projected Sales shall be set at the level of actual sales invoiced for that country in the previous Calendar Year plus *** percent (***%);

(ii) thereafter if the Projected Sales for a country cannot be agreed Projected Sales shall remain at the level of Projected Sales for the previous Calendar Year,

save that both Parties shall continue to make Commercially Reasonable Efforts to agree the actual Projected Sales for such country for the Calendar Year in question;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

3.2.9 shall determine the quantity of Product to be *** in connection with Almirall’s sales and promotion activities under the Commercialisation Plan and for use in Marketing Studies and to be ordered under Clause 9.2;

3.2.10 shall, for the avoidance of doubt, not manage the implementation of the Development Plan on a day-to-day basis (this is the responsibility of GW Pharma) and shall not manage the implementation of the Commercialisation Plan on a day-to-day basis (this is the responsibility of Almirall);

3.2.11 shall decide, on a case by case basis, if a clinical study proposed by a Party is a Clinical Trial or a Marketing Study;

3.2.12 as an output of each meeting shall prepare a report to the respective management of each Party detailing the progress of the implementation of the Development Plan and Commercialisation Plans;

3.2.13 shall ensure a regular flow of information between the Parties;

3.2.14 shall resolve all issues brought to its attention for resolution by the Development Team or the Brand Team; and

3.2.15 shall perform such other functions and responsibilities as are given to it under the express provisions of this Agreement but shall have no authority to amend any commercial terms of this Agreement or any matter that would cause any payments stated in this Agreement to be other than the amount of those terms as stated herein.

3.3 Each Party shall disclose to the other all information in its Control which is necessary to allow the JSC to work efficiently and to make decisions based on all material facts known to the Parties at the time of making their decision. No later than five (5) days prior to each meeting of the JSC, each Party will provide the other with written copies of all materials it intends to present at that JSC meeting. No later than three (3) days prior to each JSC meeting the Chairman shall circulate an agenda for such meeting to all JSC Members.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Development Team

3.4 Within thirty (30) days of the Effective Date GW Pharma shall establish a team to oversee and manage the planning and performance of the Development Plan and Lifecycle Management Plan (the “Development Team”) on behalf of GW Pharma. For clarity, responsibility for performing the Development Plan and Lifecycle Management Plan shall remain with GW Pharma.

3.5 The Development Team:

3.5.1 shall be constituted and run in accordance with GW Pharma’s normal operating model;

3.5.2 Almirall shall be entitled to appoint two (2) member with the requisite experience and authority to enable them to make decisions on behalf of Almirall with respect to matters within the remit of the Development Team. Almirall shall have the right to nominate different members from time to time to reflect the more particular functions being undertaken by the Development Team at that time. The Development Team may invite employees of GW Pharma or Almirall from time to time to be “ad hoc” members of the Development Team, at the discretion of the chairman of the Development Team. The Development Team shall meet in person on an ad hoc basis at least three (3) times in each Calendar Year but shall meet by conference call at least once in every three (3) month period to discuss progress with the Development Plan and progress with regulatory filings. The Chairman of the Development Teams shall prepare and circulate an agenda for each such meeting/conference call to each member of the Development Team at least three (3) days prior to each such meeting/conference call. The Chairman of the Development Team will be appointed by GW Pharma and such person shall also be a member of the JSC. Almirall acknowledges that information discussed and disclosed to Almirall in a Development Team meeting constitutes the trade secrets of GW Pharma and is of particular commercial sensitivity. Any use of such information by Almirall for any purpose other than the Development of the relevant Product or disclosure to or use by any Third Party would be damaging to GW Pharma’s interests.

3.6 The Development Team shall endeavour to reach consensus on all matters brought before it. GW Pharma shall disclose to Almirall’s members of the Development Team such information in GW Pharma’s Control from time to time as is necessary to allow the Development Team to work efficiently and to make decisions based on all material facts known at the time of making such decisions. Any dispute arising between the Parties in relation to the activities of the Development Team, or arising from any meeting of the Development Team shall be referred to the JSC.

Brand Team.

3.7 Within thirty (30) days of the Effective Date Almirall shall establish a team to oversee and manage the planning and performance of Commercialisation of Product on behalf of Almirall (the “Brand Team”). For clarity, Almirall shall remain responsible for Commercialising Product in the Territory.

3.8 The Brand Team will have responsibility for the brand strategy for Product, including the positioning, communications and publication strategy, market research activities and opinion leader development.

3.9 The Brand Team:

3.9.1 Shall be constituted and run in accordance with Almirall’s normal operating model;

3.9.2 GW Pharma shall be entitled to appoint to the Brand Team two (2) member with the requisite experience and authority to enable them to make decisions on behalf of GW Pharma with respect to matters within the remit of the Brand Team. GW Pharma shall have the right to nominate a different member from time to time to reflect the more particular functions being undertaken by that Brand Team at that time. The Brand Team will assign specific tasks to satellite teams and a GW Pharma employee(s) may be appointed by the Brand Team to be a member of, or lead, one or more satellite teams. The Brand Team may invite employees of Almirall or GW Pharma from time to time to be “ad hoc” members of the Brand Team, at the discretion of the chairman of the Brand Team. The Brand Team shall meet in person on an ad hoc basis at least three (3) times in each Calendar Year but shall meet by conference call at least once in each three (3) month period to discuss progress with Commercialisation of Product. The Chairman of the

Brand Team shall prepare and circulate an agenda for each such meeting/conference call to each Member of the Brand Team at least three (3) days prior to each such meeting/conference call. The Chairman of the Brand Team will be appointed by Almirall and such person shall also be a member of the JSC. GW Pharma acknowledges that information discussed and disclosed to GW Pharma in a Brand Team constitute the trade secrets of Almirall and is of particular commercial sensitivity. Any use of such information by GW Pharma for any purpose other than the Commercialisation of Product or disclosure to or use by any Third Party would be damaging to Almirall’s interests.

3.10 The Brand Team shall endeavour to reach consensus on all matters brought before it. Almirall shall disclose to GW Pharma’s members of the Brand Team such information in Almirall’s Control from time to time as is necessary to allow the Brand Team to work efficiently and to make decisions based on all material facts known at the time of making such decision. Any dispute arising between the Parties in relation to the activities of the Brand Team, or arising from any meeting of the Brand Team, shall be referred to the JSC.

4. IMPLEMENTATION OF THE DEVELOPMENT PLAN AND LIFECYCLE MANAGEMENT PLAN

4.1 GW Pharma’s core obligation under this Agreement (and in respect of which Almirall has or will make payments to GW Pharma pursuant to an in accordance with the terms of Clauses 11.7 to 11.8 of this Agreement) shall be to use Commercially Reasonable Efforts to carry out the Development Plan and the Lifecycle Management Plan as follows:

4.1.1 GW Pharma shall implement the Development Plan (other than the Lifecycle Management Plan) in accordance with the provisions set out below. Such activities shall be carried out by GW Pharma at its own cost and expense;

4.1.2 GW Pharma shall implement the Lifecycle Management Plan in accordance with the provisions set out below, subject to payment to GW Pharma of the

Program Costs set out in the Program Budget for which Almirall is responsible as agreed by the JSC. For clarity, any *** required to be carried out by a Regulatory Authority shall be carried out by GW Pharma and at ***;

4.1.3 GW Pharma shall ensure that the various aspects of the Development Plan including the Lifecycle Management Plan are carried out in accordance with GLP and GCP as appropriate. Any animals involved shall only be used in accordance with relevant Legal Requirements and shall be provided humane care and treatment in accordance with current generally accepted veterinary practice;

4.1.4 except as otherwise provided herein GW Pharma shall have the right and responsibility to carry out all Clinical Trials and shall be responsible for making and obtaining in its own name all CTA s and other regulatory filings, permissions and other approvals required by any Regulatory Authority in the Territory in relation to the conduct of the Development Plan or Lifecycle Management Plan;

4.1.5 GW Pharma shall keep or cause to be kept detailed written records and reports of the progress of the Development Plan including the Lifecycle Management Plan in sufficient detail and in good scientific manner appropriate for all purposes including Marketing Authorisation purposes and patent purposes. These written records and reports shall properly reflect all the work done and the results achieved in carrying out such part of the Development Plan or Lifecycle Management Plan. Such records to be made available to Almirall for inspection upon reasonable notice and at Almirall’s cost and expense; and

4.1.6 GW Pharma shall be responsible for the preparation, submission, prosecution and maintenance of all MAAs and other Regulatory Authority filings and applications required to obtain all necessary Marketing Authorisations to Commercialise Product in each country in the Territory and shall maintain all

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Marketing Authorisations in each country in the Territory after obtaining such Marketing Authorisations. GW Pharma or its Affiliates shall be the owner and party of record for all such filings, applications and approvals. GW Pharma shall be responsible for its costs associated with preparation, submission, prosecution and maintenance of all filings and applications required and for ensuring compliance with all requirements of such Marketing Authorisations, including by enforcing the provisions of Clause 5.7. GW Pharma will inform Almirall in good time of all meetings with relevant Regulatory Authorities in the Territory with regard to obtaining all necessary consents to Commercialise Product. Subject to the consent of the relevant Regulatory Authority, representatives of Almirall may attend such meetings with Regulatory Authorities at Almirall’s own Cost.

4.2 GW Pharma shall have the right to sub-contract the whole of or part of the Development Plan and Lifecycle Management Plan. The appointment of any sub-contractor shall be on the following terms:

4.2.1 GW Pharma shall pay the sub-contractor for work carried out by the sub-contractor;

4.2.2 that as between GW Pharma and the sub-contractor, all results emerging from such work and any related intellectual property shall be owned by GW Pharma and shall become GW Pharma IP; and

4.2.3 that the sub-contractor shall be obligated in terms the same as Clause 17 ( Confidentiality ).

4.3 Where legally permitted under the terms of its agreements with ex-EU Partners (evidence of such permission or lack of permission to be supplied to Almirall on receipt of a request therefor), GW Pharma will inform Almirall of the Pivotal Trials to be conducted by such ex-EU Partners , (including giving Almirall the opportunity to review and comment on trial protocols where possible under the terms of GW Pharma’s agreement with such ex-EU Partners) and provide Almirall with the results and a copy of the Final Report of any such Pivotal Trial conducted outside of the Territory and Almirall shall have the right to use the same for Commercialisation of Product in the Territory, subject to fulfilling any terms and conditions imposed on the

disclosure and use of such Final Report and the clinical data contained therein by GW Pharma’s ex-EU Partners.

4.4 Subject to the approval of the protocol therefor by the JSC, Almirall shall have the right and responsibility to conduct any Marketing Studies identified by the Parties and when doing so Almirall shall conduct such Marketing Studies in accordance with GCP and shall be solely responsible for all costs and expenses thereof. Almirall shall be responsible for making and obtaining in its own name all permissions and other approvals required in the Territory in relation to the conduct of any such Marketing Study or require GW Pharma to apply for such approvals on Almirall’s behalf and at Almirall’s cost and expense.

4.5 Almirall will provide GW Pharma with the results and Final Report of any Marketing Study. Almirall shall agree to permit ex-EU Partners to use clinical data generated under a Marketing Study or a Pivotal Trial funded by Almirall, provided that Almirall receives reciprocal terms for the ex-EU Partners using this data as the ex-EU Partner requires for Almirall’s use of clinical data generated under a marketing study or a Pivotal Trial by that ex-EU Partners.

4.6 Almirall shall have the right to sub-contract the whole of or any part of any Marketing Study for which it is responsible. The appointment of any sub-contractor shall be on the following terms:

4.6.1 Almirall shall pay the sub-contractor for work carried out by the sub-contractor;

4.6.2 that as between Almirall and the sub-contractor, all results emerging from such work and any related intellectual property shall be owned by Almirall and shall become Almirall IP; and

4.6.3 that the sub-contractor shall be obligated in terms the same as Clause 17 ( Confidentiality ).

5. COMMERCIALISATION

5.1 Subject to Clause 5.16, Almirall’s core obligation in relation to Commercialisation of Product shall be to use its Commercially Reasonable Efforts to achieve Launch of the Product for the first Indication within six (6) months after the grant of Marketing Authorisation (including pricing and/or reimbursement approval where such approval

is necessary or industry practice for Launch) for Product for that Indication in each Major European Market and in the other countries in the Territory. Thereafter Almirall shall use its Commercially Reasonable Efforts in each Major European Market and in the other countries in the Territory to realise the market potential of Product for that Indication and any subsequent Indication for which GW Pharma obtains a Marketing Authorisation save as provided below:

5.1.1 As soon as Almirall considers that there is no economic case for launching Product in a specific country in the Territory and in any event within six (6) months of Marketing Authorisation for that country being granted, Almirall shall give GW Pharma written notice of this opinion and include evidence in Document form to support this opinion;

5.1.2 If GW Pharma agrees with Almirall’s opinion Almirall shall be relieved of its obligation to use Commercially Reasonable Efforts to Commercialise Product in the country in question;

5.1.3 If GW Pharma disagrees with this opinion, the Parties shall timely perform a joint evaluation of the marketing opportunity in the country in question to resolve the economic case for Launching Product in such country. If having conducted such evaluation:

(i) The Parties agree that there is an economic case for launching in a country but that Almirall does not wish to do so itself or on its own behalf, the Parties shall either:

(a) agree a plan to jointly Commercialise Product for that indication in the country in question, in which case the Parties shall negotiate a change to the terms of this Agreement with regard to Commercialisation of Product in the country in question to reflect GW Pharma’s increased role; or if no agreement under this Clause 5.1.3(i)(a);

(b) GW Pharma, in its absolute discretion, may elect to take over Commercialisation of Product in said country, in which case the right granted to Almirall under Clause 2.1 shall be deemed not to include the country in question and GW Pharma shall have the right to Commercialise Product for that Indication in

that country and shall pay a fee to Almirall equal to *** percent (***%) on GW Pharma’s Net Sales in such country. In this Clause 5.1.3 “GW Pharma’s Net Sales” shall have the equivalent meaning to Net Sales; and

(ii) If the Parties agree there is no economic case for Launch of Product in that country, the right granted to Almirall under Clause 2.1 shall continue but Almirall shall have no obligation to Commercialise Product in that country.

5.1.4 In the event that Almirall Launches Product for a particular Indication in a particular country and then withdraws it, the provisions of Section 5.1.3(b) shall apply.

5.2 By 30 June 2006, Almirall shall provide GW Pharma through the JSC with a preliminary version of its Commercialisation Plan, including pricing/reimbursement strategy and rationale for the Product, annual marketing plans and proposed budgets therefor. Such Commercialisation Plan shall be updated at least once each Calendar Year thereafter and shall be supplied to GW Pharma and be reviewed and, except with regard to pricing related matters (which are in the sole discretion of Almirall), agreed at a JSC meeting. Where such Commercialisation Plan is updated after Launch of Product in the Territory, in addition to containing details of Almirall’s proposed plans for Commercialisation, they shall also contain a summary of the progress of sales and marketing of Product in the Territory and sales forecasts for the Calendar Year covered by the Commercialisation Plan. Such plan shall be received by GW Pharma subject to the obligations of Clause 17 ( Confidentiality ).

5.3 Save as otherwise provided herein, GW Pharma undertakes and agrees that during the Term it will not, and will procure that its Affiliates do not grant any right to or appoint any other person as distributor, reseller or any person as licensee, or any other person to Commercialise the Product in the Territory nor will it, and it will procure that its Affiliates do not, directly supply for their own account the Product to distributors, resellers or users located within the Territory.

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5.4 Subject to Clause 8 GW Pharma shall, and GW Pharma shall procure that its Affiliates shall, during the Term promptly refer to Almirall (or as Almirall shall direct) all enquiries they receive for Product for Commercial sale in a country within the Territory.

5.5 Almirall shall exercise its rights conferred under this Clause 5.5 as principal and it shall not sell or otherwise dispose of Product on behalf of, or in the name of GW Pharma or any of its Affiliates.

5.6 Upon and subject to the terms and conditions of this Agreement, Almirall as the Party responsible for Commercialising Product in the Territory hereby agrees at its own cost and expense:

5.6.1 to take all steps necessary to get Product placed in an appropriate controlled drug schedule in each country of the Territory. GW Pharma shall provide all reasonable assistance therefore at GW Pharma’s cost and expense;

5.6.2 to provide GW Pharma with reasonable advance notice including, where possible, giving GW Pharma at least ten (10) Business Days notice of all material meetings or calls with Competent Authorities relating to controlled drug scheduling discussions in the Territory. GW Pharma personnel may attend such meetings or calls at GW Pharma’s own cost and expense; and

5.6.3 if requested, provide reasonable assistance to GW Pharma regarding the specific requirements of Regulatory Authorities in each country in the Territory so as to enable GW Pharma to meet its obligations under Clause 9.1.9.

5.7 Almirall shall comply with the content and terms of all Marketing Authorisations when performing its obligations hereunder to Commercialise Product.

5.8 Almirall will:

5.8.1 establish and maintain in the Territory a service for providing scientific and medical information relating to the Product in response to enquiries from healthcare professionals, its medical representatives, other medical organisations or societies and any Competent Authority in respect of matters relating to the indicated uses of Product and shall liase with GW Pharma in relation to any and each enquiry made to such service and Almirall’s

responses shall follow GW Pharma’s recommendations. Almirall shall provide to GW Pharma on a Quarterly basis a summary of scientific and medical enquiries received and the standard answers that Almirall has developed in response to such enquiries. GW Pharma shall also provide Almirall with draft answers to the frequently asked questions it receives regarding Product; and

5.8.2 taking into account GW Pharma’s recommendation through the JSC, will create and develop core sales and promotional materials and literature relating to the Product (the “Marketing Materials”) to be distributed to the medical and health community in the Territory. Almirall shall submit such Marketing Materials to GW Pharma for approval regarding compliance with the requirements of each relevant Regulatory Authority before distributing them in the Territory (which approval shall be deemed granted except when otherwise notified by GW Pharma within 15 days of receiving such Marketing Materials). GW Pharma shall consider such Marketing Materials and their compliance with the requirements of any relevant Regulatory Authority and may refuse its approval for the use of such materials if, in GW Pharma’s opinion, such materials are not appropriate or do not comply with the requirements of a Regulatory Authority.

5.9 Almirall shall establish a sales force appointed and trained in accordance with Good Industry Practice to promote the Product in the EU6 Countries and shall use Commercially Reasonable Efforts to appoint a distributor in each of the other countries in the Territory in accordance with the timetable therefore set out in the Commercialisation Plan.

5.10 Almirall shall:

5.10.1 comply at all times with all Applicable Laws pertaining to the Commercialisation of the Product in the Territory;

5.10.2 in countries within the Territory where Almirall does not have its own field sales force representatives at the time of Launch, it shall notify GW Pharma of the identity of any proposed Third Party Distributor it wishes to appoint and GW Pharma shall have ***

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days to approve the appointment of such Distributor (which approval shall not be unreasonably withheld or delayed). The terms on which a Distributor is appointed shall be consistent with the terms of this Agreement and in any event, the terms of the appointment of such Distributor shall prevent the appointment of subdistributors without first obtaining GW Pharma’s prior written approval. Almirall shall be fully responsible for each Distributor’s performance, and the appointment of a Distributor shall not in any way diminish Almirall’s obligations under this Agreement. If such a country for which Almirall gives GW Pharma notice that it intends to appoint a Third Party Distributor is one in which GW Pharma wishes to sell and market Product GW Pharma shall have the right to elect do so itself on giving written notice to Almirall. If GW Pharma gives such notice GW Pharma shall pay Almirall a fee equal to *** per cent (***%) on GW Pharma’s Net Sales in such country and otherwise will be appointed as Almirall’s distributor for that country on the non-financial terms agreed by Almirall with its proposed Third Party Distributor for that country. For each other country in the Territory in which Almirall does not have a distributor GW Pharma shall have the right to elect to distribute and market Product itself in that country on giving written notice to Almirall. If GW Pharma gives such notice GW Pharma shall pay Almirall a fee equal to *** per cent (***%) on GW Pharma’s Net Sales in such country and otherwise will be appointed as Almirall’s distributor for that country on the non-financial terms to be agreed by the Parties from time to time;

5.10.3 either itself, its Affiliates or through its distributors maintain adequate facilities for the efficient Commercialisation of the Product throughout the Territory;

5.10.4 maintain or have maintained the Product, pending distribution and sale to customers, in a facility that is properly equipped (including temperature and humidity control) to store pharmaceutical and other sensitive products. GW Pharma, or its duly appointed agent, shall have the right to inspect the premises of Almirall or sub-contractor where the Product is held, stored, and/or distributed, and Almirall shall permit such inspection or arrange for such inspection no more often than once per year, upon advance notice at any reasonable time, of the methods and procedures used in the distribution,

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storage and sale of the Product and provide to GW Pharma all government inspection reports and certificates relating thereto promptly upon Almirall’s or its sub-contractors’ receipt thereof;

5.10.5 in dealing with or handling the Product follow the reasonable instructions of GW Pharma, and provide for or have provided the storage of Product in a manner consistent with the terms of the applicable Marketing Authorisation and Applicable Law;

5.10.6 in marketing and selling Product:

(i) not make any statements, representations, warranties or guarantees concerning the Product which are contrary to the Marketing Authorisation for the Product or Applicable Laws; and

(ii) avoid any misleading or deceptive marketing practices or any other promotional activities that may harm or otherwise damage GW Pharma’s or its Affiliates image or reputation, whether within the Territory or outside the Territory;

5.10.7 keep GW Pharma informed of the Commercialisation of the Product in the Territory (including but not limited to sales of the Product) by way of (i) a written report detailing the number of Units sold in each Major European Market and the Net Selling Price in each such country for each month following Launch (as reasonably available to Almirall at the time of compiling such report) and (ii) on a Quarterly basis a written report detailing on a country by country basis the number of Units sold in the previous Quarter and the Net Selling Price in the previous Quarter and summarising any material developments relating to Commercialisation of Product in the Territory during the previous Quarter. Such report shall be submitted within thirty (30) days of the end of each relevant time period. Almirall shall also promptly inform GW Pharma of any other information that it now has or which it may receive in the future which in Almirall’s opinion is likely to be of material interest, benefit, or use to GW Pharma in relation to the sale of the Products outside the Territory;

5.10.8 keep GW Pharma informed in a timely manner of any information brought to Almirall’s attention in its capacity as the Party responsible for

commercialising Product in the Territory which in Almirall’s reasonable judgment could lead to a variation of the Marketing Authorisation, Packaging or Labelling (subject to any overriding provisions of the pharmacovigilance procedures agreed pursuant to Clause 10.21); and

5.10.9 retain and archive all documentation relating to the Product received by Almirall in its capacity as the Party responsible for Commercialising Product in the Territory, including, in particular, documentation relating to regulatory matters.

5.11 Almirall shall be responsible for all costs and expenses associated with its Commercialisation activities.

5.12 Subject to Clauses 5.1.1 to 5.1.4, Almirall (as the Party responsible for Commercialising Product in the Territory), at its sole cost and expense, shall be responsible for obtaining all ancillary necessary permissions, consents and licences (additional to the Marketing Authorisation), required to Commercialise the Product in each country in the Territory under any Applicable Law, such as any import approvals, wholesale dealer’s licenses and pricing and reimbursement approvals. GW Pharma agrees to reasonably cooperate with Almirall in obtaining any such additional necessary authorisations and approvals required to Launch the Product in each country in the Territory, including representatives of GW Pharma attending meetings with the relevant Competent Authorities together with Almirall (subject to the consent of such Competent Authority) at GW Pharma’s own cost and expense for such attendance. Almirall will inform GW Pharma in good time of all meetings with relevant Competent Authorities. Where it is not legally permissible for Almirall to obtain any such necessary permission, consent or licence on its own behalf or in its own name, GW Pharma shall assume such responsibility at Almirall’s cost and expense. In the event GW Pharma is not able to obtain such permission, consent or licence on behalf of a Almirall in a particular Country in the Territory the Parties shall meet and agree a procedure to allow the Commercialisation of Product in the Country in question.

5.13 Almirall shall be free to set the sales price of Product in each country in the Territory.

5.14 Almirall (as the Party responsible for Commercialising Products in the Territory) shall during the Term of this Agreement fulfil all of its obligations as the Party responsible

for Commercialising Products in the Territory and covenants hereunder in a manner that is consistent with Good Industry Practice.

5.15 Almirall shall not:

5.15.1 advertise the Product or canvass or solicit orders for the Product outside the Territory; or

5.15.2 open branches for the sale of the Product outside the Territory; or

5.15.3 maintain distribution depots for the Product outside the Territory.

5.16 In addition to Clause 5.1, Almirall’s and its Affiliates’ core obligations in relation to Commercialisation of Product in the Territory shall be as follows:

5.16.1 to incur the Launch Commitment. At the end of the *** month period following Launch Almirall shall demonstrate to GW Pharma that Almirall has satisfied such obligation;

5.16.2 to incur the Detailing Commitment. At the end of the *** month period following Launch Almirall shall demonstrate to GW Pharma that Almirall has satisfied such obligation; and

5.16.3 save where there is a Significant Event, in which case Almirall shall be relieved of its obligations for the duration of that event, in each Calendar Year of this Agreement (or part thereof) commencing at least *** months after Launch, Almirall shall purchase from GW Pharma and pay for the number of Units of Product at the Supply Price therefor equal to *** per cent (***%) of the Projected Sales for each country in the Territory in that Calendar Year (or part thereof). If for *** Calendar Years Almirall has not met *** per cent (***%) of the Projected Sales for a country in the Territory in each of such Calendar Years Almirall shall be deemed to be in material breach under Clause 19.2. Almirall may remedy such breach by making within ninety (90) days of the end of such *** Calendar Year, a balancing payment to GW Pharma such that:

(i) where Almirall has met less than *** per cent (***%) of the Projected

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Sales for a country in the Territory in each of such Calendar Years, GW Pharma receives monies equivalent to the sum it would have received if the number of Units of Product equivalent to *** per cent (***%) of Projected Sales in each of such Calendar Years had been purchased from GW Pharma at the Supply Price; and

(ii) where Almirall has met greater than *** per cent (***%) of the Projected Sales for a country in the Territory in each of such Calendar Years but less than *** per cent (***%) of the Projected Sales for a country in the Territory in each of such Calendar Years, GW Pharma receives monies equivalent to the sum it would have received if the number of Units of Product equivalent to *** per cent (***%) of Projected Sales in each of such Calendar Years had been purchased from GW Pharma at the Supply Price.

6. MARKET STUDIES

6.1 Any Marketing Study shall be carried out by Almirall on the terms of Clause 4.4.

6.2 All rights in and to any data, results, information, inventions, discoveries and/or improvements arising out of the performance of a Marketing Study, whether patentable or not, conceived, made, obtained or developed (the “Data Package”) pursuant to a Marketing Study performed in the Territory shall vest in and remain the property of Almirall, provided always that the rights in such Data Package shall be the subject of the grant of rights to GW Pharma under Clause 2.2, save that where an ex-EU Partner will not allow GW Pharma to share clinical trial data generated by such ex-EU Partner with Almirall as set out in Clause 4.3, the grant of rights pursuant to Clause 2.2 shall not include the right to grant any rights to the Data Package to such ex-EU Partner.

7. NEW INDICATIONS

7.1 Within:

7.1.1 ninety (90) days of the Effective Date the Parties shall, through the medium of the JSC, meet to discuss the possibility of adding following Indications to the Development Plan:

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(a) ***;

(b) ***; and

7.1.2 one hundred and eighty (180) days of the Effective Date the Parties shall decide whether to add the first of such indications to the Development Plan, in which case such indication shall become a Principal Indication. The Parties shall then agree the development plan for this Indication and appropriate milestones for this Indication, which development plan shall be incorporated into the Development Plan and which milestones for this indication shall be incorporated into Clause 11 of this Agreement and the other provisions of this Agreement shall apply to such indication as if it had always been a Principal Indication.

7.2 Subject to Clause 7.1, if at any time after the Effective Date a Party comes to the opinion that Development of Product should occur for a New Indication it shall notify that opinion in writing to the other Party identifying the New Indication in question for discussion. Such a proposed New Indication may be the treatment of any illness, pathology or disease condition, recognised as a distinct indication by any Regulatory Authority. In its submission, the suggesting Party shall define the target condition and identify the potential target patient population and market opportunity. Upon receipt of such notice the Parties shall discuss, through the medium of the JSC, the New Indication and the necessary changes to the Lifecycle Management Plan and GW Pharma will conduct Clinical Trials of Product of the New Indication until completion of Phase IIa Clinical Trials at its own cost and expense. Following completion of Phase IIa Clinical Trials for such New Indication by GW Pharma, GW Pharma will promptly compile a data package, in a form set by the JSC, setting out the results of such clinical trials including all Phase IIa clinical data and the Final Report therefor (“Phase IIa Data Package”) and present it to Almirall at the next to occur meeting of the JSC. Almirall shall then review the Phase IIa Data Package and undertake its own

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decision-making process. At the meeting of the JSC following the presentation the Parties shall discuss the program for continued Development of Product for the New Indication associated with Development and at the end of the meeting Almirall shall report its decision on whether to continue Development of Product for the New Indication.

7.3 If, following such meetings:

7.3.1 the Parties agree to continue Development of Product for the New Indication and agree the Development Plan and Program Budget therefor plus appropriate sales milestones for the Commercialisation of Product for the New Indication, then the Development Plan and Program Budget for the New Indication will be added to the Lifecycle Management Plan (which will be performed on the terms of Clause 4) and Almirall shall pay to GW Pharma *** and the preparation of the Final Report therefor and such cost for which the Parties have agreed Almirall shall be responsible under the Program Budget and on the timeline set out therein.

7.3.2 If the Parties cannot agree such issues the matter shall first be referred to the Chief Executive Officer of GW Pharma or equivalent position or his or her nominee and the Chief Executive Officer of Almirall or equivalent position or his or her nominee for resolution, who together shall use reasonable and good faith efforts to resolve such matters within thirty (30) days of the date such matters are referred to them for resolution. If such persons cannot agree then GW Pharma, in its sole discretion (acting rationally) and at its own cost and expense, may conduct such proposed Development.

7.3.3 If the persons referred to in Clause 7.3.1 and 7.3.2 cannot reach agreement and GW Pharma (acting rationally) elects to continue Developing Product for the New Indication on its own, following completion of Phase II POC Clinical Trials for such New Indication by GW Pharma, GW Pharma will promptly compile a data package, in a form set by the JSC, setting out the results of GW Pharma’s development plan to that point and including all

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Phase II POC clinical data and the Final Report therefor (“Phase II POC Data Package”) which it shall present to Almirall at the next to occur JSC meeting and shall at the same time offer Almirall the opportunity to have the rights to Commercialise the New Indication in the Territory for ***

(which Development Costs shall be specified in the offer) together with payment of *** per cent (***%) of the *** for the continued Development of the New Indication thereafter (which shall be estimated by GW Pharma in the offer). Almirall shall then review the Phase II POC Data Package and undertake its own decision-making process. At the next to occur meeting of the JSC following the presentation the Parties shall discuss the program for continued Development of Product for the New Indication associated with Development and at the end of the meeting Almirall shall report its decision on whether to continue Development of Product for the New Indication. The consequences of Almirall’s decision are as follows:

(i) if Almirall accepts the offer to continue Development of Product for the New Indication and the Parties agree the Development Plan and Program Budget therefor plus appropriate sales milestones for the Commercialisation of Product for the New Indication, then the Development Plan and Program Budget for the New Indication will be added to the Lifecycle Management Plan (which will be performed on the terms of Clause 4) and Almirall shall pay to GW Pharma ***

and all costs set out under the Program Budget on the timeline set out therein; or

(ii) if Almirall does not accept this offer, GW Pharma may in its sole discretion (acting rationally) and at its own cost and expense proceed with Phase III Clinical Trials.

7.3.4 At the end of Phase III Clinical Trials, GW Pharma will promptly compile a data package, in a form set by the JSC, setting out the result of the Phase III Clinical Trials, including all Phase III clinical data and the Final Report therefor (“Final Data Package”) which it shall present to Almirall at the next

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to occur JSC meeting and shall at the same time offer Almirall the opportunity to have the right to Commercialise the New Indication in the Territory for ***

(which Development Costs shall be specified in the offer) together with payment of *** per cent (***%) of the *** for the continue Development of the New Indication thereafter (which shall be estimated by GW Pharma in the offer). At the following meeting of the JSC the Parties shall discuss the potential of Product for the New Indication and at the end of the meeting Almirall shall report its decision on whether to Commercialise Product for the New Indication. The consequences of Almirall’s decision are as follows:

(i) if Almirall agrees to continue Development of Product for the New Indication and to Commercialise Product for the New Indication and the Parties agree the Development Plan and Program Budget therefor plus appropriate sales milestones for the Commercialisation of Product for the New Indication, then the Development Plan and Program Budget for the New Indication will be added to the Lifecycle Management Plan (which will be performed on the terms of Clause 4) and Almirall shall pay to GW Pharma ***

and all costs set out under the Program Budget on the timeline set out therein ; or

(ii) if Almirall does not accept this offer, all rights in the New Indication shall vest in GW Pharma and GW Pharma may itself Commercialise Product solely for the New Indication in the Territory. For clarity GW Pharma shall not grant the right to commercialise or appoint a Distributor but may sub-contract part of its Commercialisation activities. If the Parties reasonably consider that the commercial value of the First Trademark may be lessened as a result of such joint commercialisation, GW Pharma shall undertake Commercialisation of Product solely for the New Indication under a different trademark.

7.4 For clarity, when Developing Product for New Indications GW Pharma shall, in all circumstances and at all times, act reasonably and rationally and in the interest of the Product.

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8. COMPASIONATE ACCESS PROGRAMS / NAMED PATIENT SALES.

8.1 In the EU6 Countries and any other country where Almirall establishes a direct presence Almirall shall be the importer and distributor of Product in each such country in response to individual named patient prescriptions where a Marketing Authorisation for Product has not yet been granted in the country in question (“Unlicensed Product”).

8.2 In respect of the Catalan compassionate access program for six hundred (600) patients (the “Catalan Compassionate Access Program”), Almirall shall be the importer and distributor for a ***. GW Pharma shall contract for and shall book such sales.

8.3 In respect of any sales of Unlicensed Product in Spain other than pursuant to Clause 8.2, Almirall shall be entitled to charge a distribution fee on the supply of such amount of Unlicensed Product at a *** percent (***%) of the gross sales of Unlicensed Product in Spain.

8.4 In the event that there are sales of Unlicensed Product in any other EU6 country, Almirall shall be the importer and distributor of such Unlicensed Product for which it shall charge a fee equal to Almirall’s costs per annum for the *** Units per country per annum in the each major European Market (excluding Spain) and *** in any other country in the EU6 Countries. Almirall shall supply GW Pharma with written evidence of such costs. In respect of supplies above the relevant level set out above in such a country in any Calendar Year, Almirall shall be entitled to charge a distribution fee on such supply at the *** percent (***%) of the gross sales of Unlicensed Product in that country.

8.5 Prior to the grant of the first Marketing Authorisation for Product in a Major European Market, in the event that there are sales of Unlicensed Product in any other country in the Territory outside of the EU6 Countries, GW Pharma shall be free to import and distribute Unlicensed Product for such purposes. Following the grant of the first Marketing Authorisation for Product in a Major European Market, Almirall shall have the right to import and distribute (including by appointing a Distributor)

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8.6 Unlicensed Product in such countries and, having given GW Pharma notice of its intention so to do, shall be the importer and distributor of such Unlicensed Product in such countries for which it shall be entitled to charge a distribution fee on such supply at the rate of *** percent (***%) of the gross sales of Unlicensed Product in each such country.

8.7 The following sales milestone payments shall be paid by Almirall to GW Pharma upon the achievement of the following aggregate gross sales of Unlicensed Product in the Territory. Any payment made under this Clause 8.6 shall be credited against the sales milestone payment due under Clause 11.9.1.

8.7.1 *** pounds sterling (£***) when aggregate gross sales of Unlicensed Product in the Territory surpass *** Euros (€***);

8.7.2 *** pounds sterling (£***) when aggregate gross sales of Unlicensed Product in the Territory surpass *** Euros (€***);

8.7.3 *** pounds sterling (£***) when aggregate gross sales of Unlicensed Product in the Territory surpass ***;

8.7.4 *** pounds sterling (£***) when aggregate gross sales of Unlicensed Product in the Territory surpass *** Euros (€***); and

8.7.5 *** pounds sterling (£***) when aggregate gross sales of Unlicensed Product in the Territory surpass *** Euros (€***).

8.8 Prior to Almirall beginning to supply Unlicensed Product in the Territory pursuant to Clauses 8.3, 8.4 or 8.5 in circumstances where Almirall is entitled to charge a distribution fee on such supply at the rate of *** percent (***%) of the gross sales (gross amounts received for sales of Unlicensed Product) of Unlicensed Product the Parties shall meet and agree Almirall’s obligations for reporting and recording sales of Unlicensed Product in the Territory and the necessary changes to the Agreement to account for the supply of Product to meet the requirements for Unlicensed Product.

8.9 For the avoidance of doubt, the Parties hereby agree that the rights and obligations created in this Clause 8 do not (expressly or by implication) transfer or grant any

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rights to the Unlicensed Product currently owned or created in the future beyond those stated in this Clause 8.

9. GW PHARMA’S SUPPLY OBLIGATIONS

9.1 Subject to the provisions of Clause 10 GW Pharma shall:

9.1.1 be responsible at Almirall’s cost and expense for supplying all quantities of Product required by Almirall for the purposes of conducting any Marketing Study on the terms of Clause 9.2;

9.1.2 manufacture or have manufactured and to supply to Almirall such amounts of Product for Almirall’s Commercialisation of the Product in the Territory, as Almirall may order from time to time which amounts have been manufactured in the manner specified in the Marketing Authorisation for the Territory and in accordance with GMP and the Specifications;

9.1.3 Subject to Clause 9.4 use Commercially Reasonable Efforts to obtain a Manufacturing Authorisation for the purposes of manufacturing Product in relation to each and every site at which manufacture (or any part thereof) of Product shall occur, to provide Almirall with a copy of such Manufacturing Authorisation(s) and to provide Almirall with advance written notice of any proposed change to such Manufacturing Authorisation(s);

9.1.4 ensure that Product is handled and stored by it in accordance with all Applicable Laws and to ensure that it creates and retains manufacturing, analytical and distribution records, testing and releasing materials, undertakes production and quality controls, including in-process controls and all necessary stability studies, and analysis relating to the Product all in accordance with the Specification and GMP;

9.1.5 have in place a qualified person acting on GW Pharma’s behalf, who shall be responsible for batch release of Product in the Territory and to supply Product which has been released in the Territory for sale by such person in accordance with Applicable Laws;

9.1.6 procure that Almirall, or its duly appointed agent, shall have the right to inspect the premises of GW Pharma or its sub-contractor where the Product is manufactured, Packaged or Labelled, which inspections may take place no

more often than once per Calendar Year upon advance notice at any reasonable time and shall provide to Almirall all government inspection certificates relating thereto promptly upon GW Pharma’s or its sub-contractors receipt thereof;

9.1.7 ensure that no changes in chemistry and manufacturing controls specified in the CMC Data in the Marketing Authorisation for the Product in the Territory are made without having obtained the prior approval of each applicable Regulatory Authority for such changes if such approval is required;

9.1.8 keep Almirall informed in a timely manner of any information brought to GW Pharma’s attention which in GW Pharma’s reasonable judgment could lead to a variation of the Marketing Authorisation, Packaging or Labelling (subject to any overriding provisions of the pharmacovigilance procedures agreed pursuant to Clause 10.21);

9.1.9 supply the Product in Packaging as required by Almirall which incorporates all information (including the patient information leaflet) that may be required by the relevant Marketing Authorisation, any Regulatory Authority or any Applicable Law from time to time;

9.1.10 notify Almirall of the outcome of any Regulatory Authority inspection of the facilities at which Product is manufactured which impacts upon the Product;

9.1.11 retain and archive all documentation relating to the Product including, in particular, documentation relating to regulatory matters and to Clinical Trials of Product;

9.1.12 the fact that GW Pharma appoints and allocates personnel to carry out the functions described in the above clauses will not imply that such personnel provide any technical service or perform any services which could involve the transfer of any type of Know How and/or protected or unprotected intellectual property or any other information concerning industrial, commercial or scientific experience.

9.2 From time to time Almirall may place orders for samples of the Product for distribution in connection with its sales and promotions activities under the Commercialisation Plan and for use in Marketing Studies. The quantity of each such

Purchase Order are to be agreed by the JSC, save that in no event shall such quantities to be used in Marketing Studies or given away as free samples be more than is common in the industry for this sort of Product. Each such quantity ordered shall be manufactured fully in accordance with the terms of Clause 9.1 and delivered and accepted on the terms of Clauses 10.13 to 10.18 at GW Pharma’s Cost of Manufacture.

9.3 Almirall shall notify GW Pharma as soon as reasonably practicable if there is an incomplete delivery of Product having regard to the permitted margin of *** percent (***%) *** in the Firm Order quantities as detailed in Clause 10.5. If GW Pharma is notified by telephone or in person then such notification shall be confirmed by Almirall in writing. The alleged incomplete delivery shall then be promptly investigated by the Parties and in the event that it is established that a delivery is in fact incomplete, GW Pharma shall then be obliged to rectify the incomplete consignment within twenty (20) Business Days, from the later of the date of written notification or the Parties reasonably establishing that that delivery is in fact incomplete.

9.4 In order to maintain security of supply of Product for Almirall following Launch GW Pharma shall take the following steps:

9.4.1 Almirall acknowledges and agrees that GW Pharma already has a second source for each stage of its manufacturing process save steps to produce finished Product from Botanical Drug Substance. The Parties understand that GW Pharma has an exclusive arrangement with its contract manufacturer, *** (“***”), to supply Product in the Territory. The Parties also agree that it is necessary for GW Pharma to have in place a second site for manufacture of finished Product from Botanical Drug Substance (the “Second Site”). Within thirty (30) days of Almirall completing its audit of ***, Almirall shall inform GW Pharma of whether it is prepared to establish at its own manufacturing facility the Second Site. If Almirall is so willing it shall, subject to obtaining the necessary licences and consents, establish at its own manufacturing facility the Second Site and validate such site by Launch.

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In such circumstances this Second Site shall only become operational in the event that *** is unable to fulfill its supply obligations under the terms of its contract with GW Pharma. At the time of first use the Parties will negotiate an agreement pursuant to which Almirall would manufacture finished Product for GW Pharma. This agreement will include the obligation for Almirall to manufacture Product to fill orders for Product both inside and outside the Territory. For clarity, where Almirall is manufacturing finished Products pursuant to this Clause 9.4 priority shall be given to the manufacture of Product for the Territory, thereafter Almirall shall, subject to capacity at its manufacturing facility, manufacture Product to meet the requirement of GW Pharma’s ex-EU Partners in the British Isles and Canada for so long as it takes GW Pharma to validate a second site to manufacturing finished Product for these countries. If Almirall is not willing establish the Second Site at its manufacturing facilities GW Pharma shall, in its discretion, be free to identify a Third Party to provide the Second Site.

9.5 GW Pharma shall use Commercially Reasonable Efforts to obtain Marketing Authorisations for Product in the Territory with a shelf-life of at least eighteen (18) months. The steps the Parties agree that GW Pharma will take in order to obtain a Marketing Authorisation for Product with a shelf-life of at least eighteen (18) months shall be set out in the Development Plan. By 31 December 2006 the JSC shall prepare an action plan covering the steps to be taken by the Parties should GW Pharma only be able to obtain Marketing Authorisation for Product with a shelf-life of fifteen (15) months or less, such action plan shall set out (i) the necessary changes to the forecasting, ordering, delivery mechanism and supply chain set out in the Agreement to allow Almirall to effectively distribute Product and to maximise the available shelf-life of Product supplied to Almirall for permitting efficient Commercialisation, and (ii) the process for allowing Almirall to return unsold Product to GW Pharma. The Parties agree that the action plan shall contain the provision that where Almirall returns unsold Product to GW Pharma it shall pay GW Pharma for returned Product at GW Pharma’s Cost of Manufacture. Once the action plan is agreed the right of Almirall to reject Product pursuant to the second sentence of

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Clause 10.20 shall terminate. For clarity GW Pharma shall not have the deciding vote on the action plan pursuant to Clause 3.1.3.

9.6 The Parties shall, within 90 days of the Effective Date, meet to discuss the Technical Agreement.

10. FORECASTS ORDERS DELIVERY AND ACCEPTANCE

10.1 No later than six months prior to the anticipated Launch date for Product in the Territory and by the fifth day of each month thereafter, Almirall shall prepare and provide GW Pharma with a written forecast of its total requirement for Product (unlabelled anonymous vials) for at least the following eighteen (18) months (“Forecast”). Against the Product Forecast Almirall will formally call off the respective quantities in line with the Product Firm Order process described in Clause 10.3.

10.2 No later than six months prior to the anticipated Launch date for Presentation in each Territory and by the fifth day of each month thereafter, Almirall shall prepare and provide GW Pharma with a written forecast of its total requirements for Presentation (being finished Labelled and Packaged Product for country) for at least the following eighteen (18) months (“Forecast”). Against the Presentation Forecast Almirall will formally call off the respective quantities in line with the Presentation Firm Order process described in Clause 10.4.

10.3 The quantities of Products detailed in the first *** months of each Product Forecast (“Product Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of Product from GW Pharma on the terms and conditions of this Agreement (“Product Firm Order”). With respect to the total requirement for Product, Almirall shall issue to GW Pharma by the fifth Business Day of each month a Product Firm Order for the quantity of Product (unlabelled anonymous vials) required in the fourth month of the Product Forecast. For the avoidance of doubt the first Product Firm Order will consist of a quantity of Product ordered for the *** month *** months ***. The Parties agree that all Firm Orders for the Products placed by Almirall under this Agreement shall be supplied on the terms of this Agreement.

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10.4 The quantities of Presentations detailed in the first month of each Presentation Forecast (“Presentation Firm Order Period”) shall constitute a binding commitment on Almirall to purchase such quantities of the Presentations from GW Pharma on the terms and conditions of this Agreement (“Presentation Firm Order”). With respect to the total requirement for Presentation, Almirall shall issue to GW Pharma by the tenth Business Day of each month a Presentation Firm Order for the quantity of Presentations (being finished Labelled and Packaged Product for country) required in the following month of that Presentation Forecast. The sum of the Presentation Firm Order quantities to be Labelled and Packaged shall be no greater than the total Product Firm Order for that month as described in Clause 10.3. The quantities to be Labelled, the ‘labelling plan’, will be documented and attached as part of the Presentation Firm Order.

10.5 In determining Product Firm Order quantities, Almirall shall take account of manufacturing batch sizes, such that Almirall must accept as fulfilled orders actual quantities of Products manufactured which are within a margin of *** percent (***%) of the Product Firm Order quantity. In the event GW Pharma manufactures Product quantities in an aggregated shortfall *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the initial manufacturing batch size for the Products six (6) months in advance of anticipated Launch.

10.6 In determining Presentation Firm Order quantities and the labelling plan, Almirall shall take account of labelling batch sizes of *** (subject to GW Pharma confirmation), such that Almirall must accept as fulfilled orders actual quantities of labelled Presentations which are within a *** percent (***%) of the Presentation Firm Order quantity. In the event GW Pharma supplies quantities in an aggregated shortfall of *** percent (***%), then GW Pharma shall be obliged to make up such shortfall quantities as early as possible. GW Pharma shall notify Almirall of the minimum labelling batch size for the Presentations six months in advance of anticipated launch.

10.7 Almirall agrees to discuss (via conference call) with GW Pharma on a monthly basis,

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no later than the 10th Business Day of the month, the latest Forecasts sent by Almirall, for each Territory. The purpose of this discussion is for Almirall to explain changes made to the Forecasts and to highlight any future developments in the Territory that may affect future Forecasts. GW Pharma will document the monthly demand management discussion and send a summary of the discussion to Almirall within 5 Business Days thereof. GW Pharma will also review whether the latest Forecasts raise any issues regarding GW Pharma’s ability to supply Product to meet anticipated future demand. If potential issues arise GW Pharma will respond to Almirall within thirty (30) days with an action plan responding to the issues.

10.8 In addition to the requirements of Clause 9.4.1 GW Pharma shall hold sufficient stocks of both CBD Botanical Drug Substance and THC Botanical Drug Substance to meet the Forecast requirements during the Product Firm Order Period and up to *** percent (***%) of the Product Forecast requirements detailed in the months ***. For clarity, this means that GW Pharma shall hold sufficient stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form to cover the Firm Order Period ***% of the demand for months *** but in any event shall hold stocks of CBD Botanical Drug Substance and THC Botanical Drug Substance in bulk form necessary to manufacture a volume of Product equal to or greater than the total volume of Almirall’s Firm Orders for the previous six (6) months. Both Parties shall conduct their businesses so as to minimise any stock write-offs.

10.9 GW Pharma shall hold, at GW Pharma’s cost, safety stocks of printed packaging components as agreed with Almirall. These safety stock targets shall be reviewed on a monthly basis, in the light of monthly Presentation Forecast, and any changes shall be documented as part of the demand management process described in Clause 10.7. Any write off of printed packaging materials is as agreed under Clause 14.4.1 and 14.4.2.

10.10 Almirall may ask GW Pharma for additional quantities to be manufactured and delivered by GW Pharma during the Firm Order Period. GW Pharma shall use its reasonable efforts to comply with Almirall’s additional demand. In any case GW Pharma shall give notice to Almirall within ten (10) Business Days of the receipt of the written order of its ability to meet such additional quantity.

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10.11 It is understood that volumes detailed in each Forecast for the months following the Firm Order Period constitute a good faith estimate of future requirement of Product by Almirall, its Affiliates and distributors and do not comprise a minimum purchase requirement or a binding commitment on Almirall. Almirall recognises that GW Pharma will commit to resources and materials against the Forecast and that these decisions rely on GW Pharma understanding the future demands using the process described in Clause 10.4.

10.12 GW Pharma shall respond to each Firm Order received from Almirall within three (3) Business Days of receipt. The response shall include confirmation of the quantity set out in the Firm Order and the date by which GW Pharma will be able to deliver the Product. In the event that discussion is required regarding the timing of delivery then the relevant personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Firm Order within four (4) Business Days of receipt by GW Pharma of the original Firm Purchase Order except during the period 20th December to 6th January in each Year when the periods of three (3) or four (4) Business Days referred to herein shall be replaced by eight (8) Business Days in each case.

10.13 All Product supplied under this Agreement shall be delivered FCA (Incoterms 2000) *** premises located in *** and shall be accompanied by a written Certificate of Analysis and Release confirming that such quantity of Product meets the Specification, a Packing-list and an insurance policy. GW Pharma shall secure transport and insurance, from Wockhardt to Sant Andreu de la Barca (Barcelona) or its nominee’s facility in Europe, with its own providers at Almirall’s cost and expense. Almirall shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Product purchased by Almirall hereunder which amounts shall be separately set forth on GW Pharma’s invoices to Almirall. Title and risk of loss and damage to Product purchased by Almirall hereunder shall pass to Almirall upon collection of the Product by the Third Party carrier.

10.14 Almirall has the right, at anytime and in an order-by-order basis, to secure transport or insurance with its own Almirall providers, by communicating such decision to GW

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Pharma in the correspondent Presentation Firm order.

10.15 Following receipt of a shipment of Product from GW Pharma, Almirall or its designated agent shall, within five (5) days, carry out a visual inspection (as defined below) of such shipment to ensure that Packaging and Labelling of Product has taken place in accordance with the Specification and is accompanied by an associated Certificate of Analysis and if Almirall determines in its sole discretion (exercised reasonably) that it has not so taken place it shall promptly notify rejection of shipment to GW Pharma in writing. Subject to the provisions of Clause 10.16, if Almirall does not notify GW Pharma of rejection of such shipment within such five (5) days, such shipment of Product shall be deemed to have been accepted.

10.16 For the purposes of this Agreement, “visual inspection” shall mean:

10.16.1 comparing the applicable order against the documentation accompanying the shipment to verify that the delivery date, identity, quantity and exterior shipment labelling comply with the order;

10.16.2 verifying that the Certificate of Analysis for the shipment states that the Product conforms in all material respects to the applicable Specifications;

10.16.3 visually inspecting the exterior of the shipment of Products to verify that the shipment appears to be in good condition; and

10.16.4 verifying that the temperature of the shipment has remained within specification by reviewing the data logger information.

For the avoidance of doubt, visual inspection does not include laboratory analysis.

10.17 Notwithstanding the foregoing, GW Pharma shall remain liable to Almirall to the extent provided in Clause 10.19 or 10.20 as appropriate for any latent defect that subsequently is discovered which renders the Product unsaleable, if such defect is due to the failure of Product to meet Specification and/or GMP and provided that Almirall immediately inform GW Pharma by notice in writing of such defect and rejection of the relevant shipment not later than ten (10) Business Days from the date of discovery of such latent defect.

10.18 Within 10 days of receipt by GW Pharma of a notice of rejection from Almirall in accordance with Clauses 10.15 or 10.17 GW Pharma shall indicate in writing to

Almirall whether GW Pharma is issuing a return authorisation or not. In the event that a return authorisation is so issued Almirall shall return to GW Pharma at GW Pharma’s expense the quantities of Product in question and GW Pharma shall replace such quantities within twenty (20) Business Days or as soon as reasonably practicable thereafter. If the payment in respect of such quantities is outstanding, it shall be postponed until such replacement quantities are received and accepted by Almirall in accordance with this Clause 10.

10.19 After receipt of any rejection notice from Almirall pursuant to Clause 10.15 or Clause 10.17 if GW Pharma does not issue a return authorisation under Clause 10.17 GW Pharma shall analyse any batch of Product rejected by Almirall for non-conformity with the Specifications within twenty (20) Business Days of receipt of such notice, and present its findings with respect to such Product to Almirall. If such tests confirm non-conformity with the Specification GW Pharma shall promptly supply to Almirall (at GW Pharma’s cost and expense) a conforming batch in the same quantity as the rejected batch and shall reimburse Almirall for any out of pocket costs or expenses incurred by Almirall including shipping charges in relation to such non-conforming batch. If the Parties cannot agree on whether the batch of Product in question conforms to the Specifications, an independent qualified laboratory reasonably acceptable to both Parties, and at a cost equally shared by both Parties, shall analyse both Almirall’s and GW Pharma’s samples of Product in question, and the definitive results of such laboratory shall be binding on the Parties. If the batch of Product in question is determined to be non-conforming, such non-conforming Product shall be held for GW Pharma’s disposition, or shall be returned to GW Pharma, in each case at GW Pharma’s expense, as directed by GW Pharma no later than ten (10) Business Days following such determination. GW Pharma shall replace each non-conforming batch of Product, or the non-conforming portion thereof, with conforming Product within twenty (20) Business Days or as soon as reasonably practical after receipt of notice of rejection thereof. If the batch of Product in question is determined to be conforming and provided that the Certificate of Analysis did not indicate it to be non-conforming, such Product shall be returned to Almirall at Almirall’s cost and expense.

10.20 GW Pharma shall employ stock rotation methods and techniques consistent with Good Industry Practice so as to ensure that Product delivered to Almirall has a minimum of seventy-five per cent (75%) of its shelf life unexpired, provided the

approved shelf-life is at least of sixteen (16) months. Almirall has the right to reject any Product with less than *** months of remaining shelf-life and save as otherwise agreed between the parties pursuant to Clause 9.5.

10.21 The Parties agree that the costs of recall shall be met as follows: if a recall arises due to any act or omission by Almirall the Cost of Manufacture, distribution expenses and third-party recall expenses (collectively, the “Recall Costs”) shall be borne by Almirall; if a recall arises from any other reason then the Recall Costs shall be borne by GW Pharma. Almirall shall maintain records of all sales of Product and customers sufficient for Almirall or GW Pharma (as appropriate) to adequately administer a recall for the period required by Applicable Law.

11. PRICE AND PAYMENT TERMS

11.1 In fulfilment of its core obligation under this Agreement to Commercialise Product, Almirall shall purchase from GW Pharma all of its requirements for Product at the Supply Price. Such price shall apply before and from Launch. In the event that GW Pharma reasonably considers that the Supply Price will be lower than GW Pharma’s Fully Burdened Cost of Manufacture, GW Pharma shall provide evidence to Almirall to support its position and the Parties shall promptly meet to discuss and agree a feasible solution to this problem.

11.2 Upon shipment of Product to Almirall, GW Pharma shall submit invoices to Almirall, on a country by country basis, as follows:

11.2.1 during the period from Launch to the end of the Calendar Year in which Launch occurs GW Pharma shall invoice Almirall for Product at a price per Unit of *** percent (***%) or *** percent (***%) as applicable of the List Price;

11.2.2 thereafter for each Calendar Year GW Pharma shall invoice Almirall for Product at a price per Unit of *** percent (***%) or *** percent (***%) as applicable of the Net Selling Price (for that country) as calculated for the previous Calendar Year;

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11.2.3 For clarity, GW Pharma shall invoice Almirall for Product at a price per Unit of *** percent (***%) of the Net Selling Price (or List Price in the first Calendar Year or part thereof following Launch) until the end of the Initial Period and thereafter at the price per Unit *** percent (***%) of the Net Selling Price (or List Price in the first Calendar Year or part thereof following Launch);

the applicable price in any circumstance being the Invoice Price. The total amount invoiced in any Calendar Year for manufacturing and supplying Product for a specific country being the Invoice Income. Almirall shall pay each invoice in full within sixty (60) days after the date of invoice. All invoices shall be stated in Euros and payments shall be made in Euros.

11.3 Within thirty (30) days of the end of a Calendar Year Almirall shall submit to GW Pharma a report on each country in the Territory, containing the following information:

11.3.1 a stock reconciliation showing the number of Units of stock brought forward from the previous Calendar Year, the number of Units purchased in the Calendar Year in question and the Invoice Price therefor, the number of Units sold in the Calendar Year in question and the gross amounts received by Almirall or its Affiliates (the “Gross Sales”), any other stock movements (such as, but not limited to: returns; samples; expiries) and the number of Units of stock carried forward into the new Calendar Year;

11.3.2 a reconciliation of the total Gross Sales for the Calendar Year to the total Net Sales for the Calendar Year;

11.3.3 The calculation of the Net Selling Price being the Net Sales of all Product in a specific country in the Calendar Year in question divided by the number of Units of Product sold in that Calendar Year. For the avoidance of doubt it is declared and agreed that the number of Units sold does not include Units used in Marketing Studies or Units given away as free samples. These Units shall not be counted when calculating the Net Selling Price.

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11.4 Within fifteen (15) days of receipt of the report under Clause 11.3 the Parties shall agree the new Invoice Price for the Product by country based on the Net Selling Price of the Product in that country in the Calendar Year just ended.

11.5 Within fifteen (15) days of receipt of the report under Clause 11.3 the Parties shall also agree the reconciliation on a country by country basis of the Invoice Income for the Calendar Year in question to the GW Sales Income for that Calendar Year. These figures shall be reconciled to take into account the amount of Product sold by Almirall and should be adjusted for the amount of Product held in stock by Almirall for that country at the Calendar Year end, as follows:

11.5.1 the GW Sales Income for the Calendar Year in question;

11.5.2 less the value of Product held in stock by Almirall at the beginning of the Calendar Year, being the number of Units held multiplied by the applicable Invoice Price as used in that Calendar Year (which should agree to the stock brought forward figure reported under Clause 11.3.1);

11.5.3 plus the value of Product written off in the Calendar Year in question (other than product rejected in accordance with Clauses 10.15 or 10.17), being the number of Units written off multiplied by the applicable Invoice Price as used in that Calendar Year;

11.5.4 plus the value of Product held in stock by Almirall at the end of the Calendar Year in question being the number of Units held multiplied by the Invoice Price to be used in the forthcoming Calendar Year (which should agree to the stock carried forward figure reported under Clause 11.3.1);

11.5.5 less the Invoice Income for the country in question in that Calendar Year;

11.5.6 the total of the calculation being the balancing payment due. GW will then raise an invoice or credit note accordingly and the Party which this calculation shows needs to make a balancing payment shall pay the amount due to the other within thirty (30) days of the relevant meeting being held. Any dispute between the Parties as to the basis of the calculation shall be resolved in accordance with the mechanism set out in Clauses 11.14 and 11.15. The above calculation is designed to adjust the price of the Product held in stock by Almirall at the Calendar Year end to the new Invoice Price for that country for the new Calendar Year such that goods in transit or

timing differences should be taken into account in the above calculation to make the numbers used equitable between the Parties.

Initial Payment

11.6 In consideration of the willingness of and as an inducement to enter into this Agreement, Almirall has paid GW Pharma on the Effective Date and upfront amount equal to twelve million pounds sterling (£12,000,000) (the “ Initial Payment ”).

Milestone payments

11.7 The following Development milestone payments shall additionally be paid by Almirall to GW Pharma:

11.7.1 ***;

11.7.2 ***;

11.7.3 ***;

11.7.4 ***;

11.7.5 ***.

For clarity, in the event one Pivotal Trial is substituted for another Pivotal Trial under the Development Plan the relevant milestone will still apply and become payable on the successful completion of the substituted Pivotal Trial.

11.8 The following regulatory approval milestone payments shall be paid by Almirall to GW Pharma:

First Indication to be granted a Marketing Authorisation

11.8.1 ***;

11.8.2 ***;

11.8.3 ***;

11.8.4 ***.

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For clarity, in each Major European Markets where additional approvals such as pricing and reimbursement approvals are necessary or industry practice for Launch in that country, such milestone shall be paid on achievement of such necessary approvals, but as soon as Almirall Launches the Product in such Major European Market, all approvals from the Regulatory Authorities shall be deemed to have been obtained for each such Major European Market and the relevant milestone shall be immediately payable.

Second Indication to be granted a Marketing Authorisation

11.8.5 ***;

11.8.6 ***;

11.8.7 ***;

11.8.8 ***.

Third Indication to be granted a Marketing Authorisation

11.8.9 ***;

11.8.10 ***.

11.8.11 ***.

11.8.12 ***.

For the purposes of Clause 11.8 the three (3) Indications are:

(i) pain or spasticity in multiple sclerosis;

(ii) pain associated with cancer; and

(iii) neuropathic pain associated with any disease other than multiple sclerosis.

11.9 The following sales milestone payments shall be paid by Almirall to GW Pharma:

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11.9.1 ***;

11.9.2 ***; and

11.9.3 ***.

11.10 Each of the milestone payments subject to Clauses 8.6, 11.7, 11.8 and 11.9 shall only be payable by Almirall upon the first occurrence of the applicable event whenever it occurs but upon the first occurrence of the applicable event the milestone payment shall be payable even if more than one occurs in a Calendar Year. Such milestone payments are non-refundable in any circumstances whatsoever.

11.11 GW Pharma shall report the occurrence of each Development milestone and each regulatory approval milestone to Almirall and at the same time shall submit to Almirall an invoice for the associated milestone payment. Almirall shall make the relevant milestone payment for which Clause 11.7 or 11.8 provides within thirty (30) days of receiving such invoice. Almirall shall report the occurrence of each milestone under Clause 8.6 and each sales milestone event to GW Pharma within thirty (30) days of its occurrence and at the same time shall make the milestone payment to GW Pharma for which Clauses 8.6 or 11.9 (as applicable) provides.

Competition

11.12 On a country-by-country basis, following the loss of all protection for Product from (i) Valid Claims of GW Pharma Patent Rights directly Covering Product, (ii) marketing exclusivity rights, and (iii) data exclusivity rights, in the country in question and the generation of competition from a Generic Competitive Product which competition reduces Almirall’s Net Sales of Product in that country in a Calendar Year compared to the Calendar Year prior to launch of the Generic Competitive Product in that country by greater *** percent (***%) the Parties shall, through the medium of the JSC, meet to discuss and agree a method for restructuring the way in which GW Pharma is compensated for the supply of Product with the aim of adapting the Supply Price to the new situation.

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General

11.13 Almirall shall make all payments to GW Pharma under this Agreement in Euros from Spain save that the Initial Payment under Clause 11.6 and all milestone payments under Clauses 8.6, 11.7, 11.8 and 11.9 shall be made in pounds sterling from Spain.

All payments under this Agreement shall be made free and clear of and without set off, deduction or deferment in respect of any taxes, disputes or claims whatsoever unless required by law or practice of any Competent Authority.

11.14 Almirall and its Affiliates shall keep and shall require its distributors to keep, full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of auditing all amounts payable to GW Pharma including evidence of the Net Selling Price, Supply Price and GW Sales Income in each Calendar Year and in compiling the reports due from Almirall under Clauses 5.10.7 and 11.3 for a minimum period of five (5) years. Upon timely request by GW Pharma, GW Pharma shall have the right to instruct an independent, internationally recognized, accounting firm to perform an audit, conducted so far as appropriate in accordance with IFRS, as is reasonably necessary to enable such accounting firm to report to GW Pharma the Net Selling Price and/or GW Sales Income for a specified twelve (12) month period, or to report to GW Pharma on the accuracy of the reports issued by Almirall under Clauses 5.10.7 and 11.3 on the following basis:

11.14.1 such firm of accountants shall be given access to and shall be permitted to examine and copy such books and records upon (i) twenty (20) Business Days notice (where such records are less than three years old), and (ii) thirty (30) Business Days notice (where such records are more than three years old), having been given by GW Pharma and at all reasonable times on Business Days for the purpose of certifying to GW Pharma either (a) that the Net Selling Price calculated and reported in any Calendar Year is correct; or (b) that the Supply Price and/or GW Sales Income calculated and reported by Almirall or its Affiliates during any Calendar Year were calculated correctly in accordance with this Agreement; or (c) that the figures in a report issued by Almirall under Clauses 5.10.7 and 11.3 during any Calendar Year were accurately calculated and reported by Almirall or its Affiliates in accordance with this Agreement (and in either case if such certification cannot be given specifying the reasons why which will enable the Parties to recalculate the relevant sums);

11.14.2 prior to any such examination taking place, such firm of accountants shall undertake to Almirall that they shall keep all information and data contained in such books and records, strictly confidential and shall not disclose such information or copies of such books and records to any third person including GW Pharma, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to issue the certificate to GW Pharma which this Clause 11.14.6 envisages;

11.14.3 any such access examination and certification shall occur no more frequently than once per Calendar Year and will not go back over records more than three (3) Calendar Years old unless a discrepancy is found;

11.14.4 Almirall shall make available personnel to answer queries on all books and records required for the purpose of that certification;

11.14.5 any such certification shall be final in so far as it relates to either (a) the Net Selling Price for a specific year, (b) the Supply Price or (c) a report issued by Almirall under Clauses 5.10.7 and 11.3; and

11.14.6 if the certification is in disagreement with the GW Sales Income as calculated by Almirall, Almirall shall notify GW Pharma within ten (10) days of receipt by Almirall whether or not Almirall agrees with the certification. If Almirall notifies its agreement with the certification within the ten (10) day period or fails to give any notification within that period, the GW Sales Income calculated by the certification shall be used for purposes of calculating any monies owed and any monies owed by one Party to the other shall be paid by that Party. The cost of the accountant shall be the responsibility of Almirall if the recalculation shows Almirall’s previous GW Sales Income figures supplied to GW Pharma to be inaccurate by more than the lesser of *** Euros (€***) or *** percent (***%) of GW Sales Income in such Calendar Year and the responsibility of GW Pharma otherwise.

11.15 If there is any dispute between the Parties as to any matter relating to the calculation of the Supply Price, the GW Sales Income or in connection with the determination of

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the Net Selling Price or if within ten (10) days starting on the day after receipt of the notification referred to in Clause 11.14.6, Almirall and GW Pharma have not agreed to the terms in dispute in relation to the certification, either Party may refer the items in dispute to a partner of at least ten (10) years qualified experience at an independent, internationally recognized, public accounting firm agreed by the Parties in writing for final and binding resolution, or failing agreement on the identity of the public accounting firm within fifteen (15) days starting on the day after receipt of the notification, an independent, internationally recognized, public accounting firm appointed on the application of GW Pharma by the President for the time being of the Institute of Chartered Accountants in England and Wales or appointed on the application of Almirall by the Asociación Profesional de Expertos Contables y Tributarios de España or similar institution in Spain. Such person appointed under this Clause 11.15 shall act as follows:

11.15.1 such person’s terms of reference shall be to determine the matters in dispute within twenty (20) days of his appointment;

11.15.2 the Parties shall each provide such person with all information relating to the items in dispute which such person reasonably requires and such person shall be entitled (to the extent he considers appropriate) to base his determination on such information; and

11.15.3 such person’s costs shall be paid by Almirall and GW Pharma as such person may determine.

11.16 All payments to GW Pharma under the terms of this Agreement are expressed to be exclusive of sales or value added tax, which may be due on any invoice and Almirall shall pay to GW Pharma in addition to those payments all such sales and value added tax for which GW Pharma is liable to account to the relevant tax authorities in relation to any supply made or deemed to be made for sales or value added tax purposes under this Agreement on receipt of a tax invoice or invoices from GW Pharma.

11.17 All payments made by one Party to the other under this Agreement shall be made by wire transfer to the bank account that may be notified by GW Pharma/Almirall to the other from time to time.

11.18 If either Party fails to make any payment to the other Party hereunder on the due date for payment and the payment is not in dispute between the Parties, or in the event of a dispute that has not been resolved, without prejudice to any other right or remedy available to that Party, that Party expecting payment shall be entitled to charge the other Party interest (both before and after judgement) on the amount unpaid at the annual rate of *** calculated on a daily basis until payment in full is made without prejudice to that Party’s right to receive payment on the due date.

11.19 For the avoidance of doubt, the Parties agree and confirm that none of the payments which Almirall is obliged to make to GW Pharma pursuant to this Clause 11 are in respect of the grant, transfer or assignment of any GW Pharma IP.

12. PHARMACOVIGILANCE

12.1 As Marketing Authorisation holder, GW Pharma retains responsibility for pharmacovigilance including liaison with, and reporting to, all relevant Regulatory Authorities in the Territory. With regard to the Territory GW Pharma will subcontract the pharmacovigilance of the Product to Almirall according to the Pharmacovigilance Agreement, to be negotiated between the Parties. The Pharmacovigilance Agreement shall establish in sufficient detail an appropriate procedure to ensure that all regulatory pharmacovigilance requirements applicable to them as contractual partners in relation to the Product can be fulfilled, and the Parties’ additional interests and obligations associated with pharmacovigilance of the Product met. The procedure shall be based on full mutual transparency, internationally acceptable quality of pharmacovigilance operations in the exchange of the safety information of the Product in a timely manner, and on the pharmacovigilance concept of one single opinion on any particular safety issue, as derived from the worldwide safety database of GW Pharma. Further, the procedure shall be based on the pharmacovigilance concept that Almirall collects safety information on the Products in the Territory and forwards it to GW Pharma who shall provide the individual case safety reports from other territories and periodic safety update reports to Almirall. The Pharmacovigilance Agreement shall be agreed within six (6) months from the

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Effective Date, and be implemented by the time Almirall initiates any activities related to the promotion, marketing or sale of Product.

12.2 In addition to the requirements of Clauses 12.1 and 10.21 and according to the Pharmacovigilance Agreement, each Party agrees to keep the other Party informed, commencing within two (2) working days of notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority, which: (a) raises any material concerns regarding the safety or efficacy of Product; (b) which indicates or suggests a potential material liability for either Party to Third Parties arising in connection with any Product; or (c) which is reasonably, likely to lead to a recall of any Product, including in all cases, but not limited to:

12.2.1 Regulatory Authority inspections of manufacturing, distribution or other related facilities, in which Product is manufactured, stored or otherwise present;

12.2.2 receipt of a warning letter from any Regulatory Authority relating to any Product; or

12.2.3 initiation of any Regulatory Authority investigations, detention, seizure or injunction concerning any Product.

13. NON COMPETITION

13.1 As of the Effective Date each Party undertakes to the other that it will not (whether acting by itself, its Affiliates or with a Third Party collaborator) carry out any development or commercialisation activities in the Territory with regard to products which have the same mechanism of action (combined activity as agonists of both CB1 and CB2 receptors at the same time) as Product for the treatment of the Indications for which Product is Developed and Commercialised under this Agreement during a period of seven (7) years following Launch of Product for each particular Indication.

13.2 The Parties acknowledge that all restrictions contained in this Clause 13 are reasonable, valid and necessary for the adequate protection of the Product business and that the Parties would not have entered into this Agreement without the protection afforded to them by this Clause 13.

14. TRADE MARKS AND DOMAIN NAMES

14.1 The Parties agree that, subject to consultation through the JSC, it shall be GW Pharma’s responsibility and expense to provide a single Trademark (the “First Trademark”) for Product satisfactory to the Competent and/or Regulatory Authorities in the Territory which can be used for Commercialisation of Product in the Territory. If at any time thereafter it is necessary to sell the Product in the Territory or any country or countries in the Territory under a trademark other than the First Trademark, GW Pharma or Almirall, as the case may be, shall send written notice to the other requesting a JSC meeting to consider the selection of a different Trademark. In the event a different Trademark is proposed by a Party: (i) the different Trademark (the “New Trademark”) must be acceptable to GW Pharma (acting reasonably) having regard to GW Pharma’s desire to have a global Trademark, (ii) the New Trademark must be acceptable to the Regulatory Authority in each jurisdiction where a use of the New Trademark would require making the change to the applicable Regulatory Application or Marketing Authorisation, (iii) all costs (including reasonable attorneys’ fees) for filing and prosecuting applications to register, and maintaining registration of such New Trademark in the Territory will be paid by (a) Almirall, if Almirall requested the New Trademark, or (b) GW Pharma, if GW Pharma requested the New Trademark, and (iv) any New Trademarks shall be registered in the name of, be owned by and be the sole property of GW Pharma and subject to the terms and conditions set forth in this Clause 14.

14.2 In relation to any Trademark other than the First Trademark, if any Competent or Regulatory Authority in the Territory insists on the use of a trademark other than such Trademark in such country, GW Pharma or Almirall, as the case may be, shall send written notice to the other requesting a JSC meeting to consider the issue. At such committee meeting the Parties shall agree either (i) that the Trademark should be changed in all countries including the Territory (in which case the terms set out in Clause 14.1(i) (ii) and (iv) shall apply) or (ii) that the preferable course is to adopt a different trademark only in the Territory (in which case the term set out in Clause 14.1(iv) shall apply). In either case all costs (including reasonable attorneys’ fees) for filing and prosecution any new trademark applications will be shared equally by the Parties.

14.3 Almirall agrees to Commercialise Product solely under the Trademark. Almirall shall ensure that each reference to and use of the Trademark by Almirall in any marketing material related to the Product is acceptable to GW Pharma as specified in Clause 14.5 and is accompanied by an acknowledgement that the Trademark is a trademark or registered trademark owned by GW Pharma and used in the course of the business by Almirall solely in connection with the Commercialising rights and obligations attributed to Almirall under this Agreement.

14.4 The Parties shall, through the medium of the JSC, discuss and agree the initial Trade Dress, Packaging and Labelling for Product. For clarity, if there is any dispute between the Parties relating to the initial Trade Dress, including its design the final decision shall be Almirall’s. If there is any dispute between the Parties regarding the Packaging (other than the Trade Dress), or Labelling of finished Product the final decisions shall be GW Pharma’s (which decision shall be made in accordance with the requirement of the relevant Marketing Authorisation). Once agreed, GW Pharma shall specify such Trade Dress in each Marketing Authorisation for Product.

14.4.1 GW Pharma shall bear the initial costs in respect of preparation of artwork and Labels for Product for Launch in each country in the Territory. Almirall shall bear any subsequent costs for changes to artwork or Labelling requested by Almirall during the Term. Almirall shall bear the write-off costs in respect of packaging components, resulting from artwork or Labelling changes requested by Almirall;

14.4.2 GW Pharma shall bear the artwork and Labelling costs arising from any artwork and Labelling changes instigated by the Regulatory Authority or arising for regulatory reasons implemented by GW Pharma as holder of the relevant Marketing Authorisation;

14.4.3 GW Pharma shall ensure that the external Packaging of the Product includes Almirall’s name and logo. Save as required by any Applicable Law, GW Pharma will not affix to any of the Products any trademark (other than the Trademark and Almirall’s name and logo) business name, label or sign other than as may previously have been approved in writing by Almirall (such approval not to be unreasonably withheld or delayed). For the avoidance of doubt, the inclusion of Almirall’s name and logo on the external Packaging

of the Product shall not (expressly or by implication) result in the assignment, licence or transfer of any GW Pharma IP;

14.4.4 Save as required by any Applicable Law, GW Pharma shall not make any change to the layout, content or appearance of any Labelling of Product without the prior written consent of Almirall (such approval not to be unreasonably withheld or delayed). Almirall shall not alter the Packaging or Labelling of the Product nor shall Almirall conceal or otherwise obscure, remove or otherwise interfere with the Trademarks or other markings, which GW Pharma may include on the Packaging or Labelling of the Product.

14.5 A copy of the marketing material (which the Parties agree may be in draft layout) using or otherwise containing the Trademarks in the form to be distributed, referenced or otherwise used by Almirall in connection with its Commercialisation of the Product shall be provided to GW Pharma not less than thirty (30) days before Almirall intends to release, distribute, reference or use such material and GW Pharma shall have fifteen (15) Business Days from receipt of the same to provide Almirall with any comments or suggested amendments in relation to the use of the Trademark. Almirall shall take such reasonable comments or suggested amendments into account subject always to GW Pharma’s responsibilities as the holder or intended holder of the Marketing Authorisation relating to Product. If GW Pharma does not provide any comments or suggested amendments within such fifteen (15) Business Day period GW Pharma shall be deemed to have approved the use of the Trademarks in such marketing material. The restrictions of this Clause 14.5 shall not apply in relation to marketing or promotional material relating to Almirall (as opposed to the Commercialisation of Product) and Almirall shall be free to use the Trademarks in Almirall’s own promotional material and presentations (for example, company presentations during fund raising activities).

14.6 Almirall shall provide GW Pharma with information and examples as to Almirall’s use of the Trademarks, as GW Pharma may request, to permit GW Pharma’s proper maintenance and registrations of the Trademarks.

14.7 Almirall expressly acknowledges that GW Pharma owns the Trademarks, and the goodwill associated therewith. Almirall shall not attack, dispute, or contest the validity of GW Pharma’s ownership of the Trademarks or any registrations issued or

issuing with respect thereto, both during the Term and/or thereafter. Almirall further agrees that any use of the Trademarks within the course of its business activity of Product Commercialisation by Almirall shall be for the benefit of GW Pharma and any goodwill accrued in connection with the use and display of the Trademarks shall accrue solely to the benefit of GW Pharma and not Almirall. In the event Almirall acquires any rights relating to the Trademark for any reason, Almirall agrees to assign to GW Pharma, at no cost to GW Pharma, all such rights, together with any related goodwill. Almirall shall not do or perform any act that may endanger, destroy, or similarly affect the value of the goodwill pertaining to the Trademarks nor do any act that might support a petition to cancel or otherwise invalidate any registration relating to the Trademarks or cause the applicable registrar to require a disclaimer of exclusive rights in such Trademarks nor assist any other person or other entity, directly or indirectly, in so doing. Almirall will, at any time, upon the request of GW Pharma, execute any documents reasonably required by GW Pharma to confirm GW Pharma’s ownership of all such rights in the Trademarks.

14.8 Almirall shall not sell or otherwise distribute Product under any other trademark, logo or other indicia other than as contemplated under the terms and conditions of this Agreement.

14.9 From the Effective Date neither Party shall use any trademarks or trade names (other than the Trademarks) so resembling the Trademarks so as to be likely to cause confusion, dilution, or deception. Almirall shall not register the Trademarks in its own name nor attempt to register any trademarks, marks, or trade names confusingly similar to the Trademarks.

14.10 Before using a domain name in connection with the Product, Almirall and GW Pharma shall agree as to the design of the homepage of such domain name, such agreement not to be unreasonably withheld or delayed. GW Pharma shall own all domain names.

15. INTELLECTUAL PROPERTY - INITIAL FILINGS AND OWNERSHIP

15.1 Any and all GW Pharma IP referred to in this Agreement will remain the property of and shall remain vested in GW Pharma. In the same sense, all Almirall IP referred to in this Agreement will remain the property of and shall remain vested in Almirall. Any Know How or Patent Rights covering Product arising or generated by either

Party during the Term and resulting from Development shall be GW Pharma IP and shall be owned solely by GW Pharma, and any Know How arising or generated by either Party during the Term and resulting from Commercialisation shall be Almirall IP and shall be owned solely by Almirall.

15.2 Forthwith following the Effective Date and during the Term, in order for Almirall to carry out its commercialisation and distribution activity, GW Pharma shall disclose and make available to Almirall the GW Pharma IP which will be necessary for Almirall to Commercialise Product in the Territory and any other information in GW Pharma’s control which GW Pharma, acting reasonably, believes will be helpful to Almirall for Commercialising Product in the Territory which information shall be treated by Almirall as GW Pharma’s Confidential Information. The disclosure and making available of information shall not result in the granting of any rights or licence in the respect of the GW Pharma IP.

15.3 Forthwith following the Effective Date and during the period of this Agreement Almirall shall disclose and make available to GW Pharma all Almirall IP conceived, generated or developed by Almirall. The disclosure and making available of information shall not result in the granting of any rights or licence in respect of the Almirall IP.

15.4 Each of the Parties shall do all such acts and things and execute all such deeds and documents as may be necessary or desirable for them to perfect their title in the GW Pharma IP or Almirall IP (as applicable) and otherwise implement the provisions of this Clause 15.

16. IP - MAINTENANCE PROSECUTION AND DEFENCE

16.1 GW Pharma shall at its own cost and expense be solely responsible for the filing, prosecution and maintenance of GW Pharma Patent Rights and the Trademarks in the Territory using reasonable endeavours to prosecute all patent applications forming part of GW Pharma Patent Rights and all Trademarks applications forming part of Trademarks to grant, including the conduct of any claims or proceedings relating to them (including but not limited to any interference, reissue or re-examination or opposition or revocation proceedings). GW Pharma shall keep Almirall promptly informed of all filings made for GW Pharma Patent Rights and Trademarks including sending Almirall a copy of any such filing and otherwise shall keep Almirall informed

of all material developments in relation to the GW Pharma Patents and Trademarks and shall, upon Almirall’s request, provide Almirall with copies of relevant documents related to the filing, prosecution and maintenance of the GW Pharma Patent Rights and Trademarks.

16.2 In the event that GW Pharma declines to file or, having filed, declines to further prosecute and maintain any pending GW Pharma Patent Rights or Trademarks in the Territory, GW Pharma shall provide Almirall with written notice thereof. In the case where GW Pharma has filed but is declining to further prosecute or maintain GW Pharma Patent Rights or Trademarks, such notice shall be given at least thirty (30) days prior to the expiration of any official substantive deadline relating to such activities. In any of such circumstances Almirall shall have the right to decide that Almirall should file, continue to file or prosecute such GW Pharma Patent Rights or Trademarks on behalf and in the name of GW Pharma as sole owner and propietor of the Trademarks and GW Pharma Patent Rights and, in such case, Almirall shall give written notice to GW Pharma. GW Pharma shall upon receipt of any such notice from Almirall transfer to Almirall all its files relating to the relevant GW Pharma Patent Rights or Trademarks and execute any documents to transfer control of such filing, prosecution and maintenance to Almirall and thereafter Almirall shall be responsible for the cost and expense of prosecuting and maintaining such GW Pharma Patent Rights or Trademarks.

16.3 Notwithstanding any other provision of this Clause 16, the Parties shall cause their patent attorneys to liaise so far as practicable with respect to the filing, prosecution and maintenance of Patents Rights falling within GW Pharma Patent Rights and the Trademarks. Each Party shall be responsible for the cost of its own patent attorney incurred pursuant to this Clause 16.3.

16.4 In the case where either Party believes that an infringement by a Third Party of the GW Pharma IP (including the Trademarks) may be occurring, such Party shall disclose full details of the potential infringement to the other Party.

16.5 In order to protect GW Pharma IP rights (including Trademarks), where an infringement of GW Pharma IP (including the Trademarks) is occurring in the Territory Almirall shall have the first right to, but shall not be obliged to, at its own cost and expense, enforce the same in accordance with the following:

16.5.1 Almirall shall have sole conduct of the claim and any proceedings including any counterclaim for invalidity or unenforceability or any declaratory judgment action and including the right to settle. Where Almirall decides to commence proceedings in relation to GW Pharma IP it shall be entitled to require GW Pharma to join Almirall as co-plaintiff. In such case GW Pharma shall provide all necessary assistance to Almirall in relation to any such proceeding at GW Pharma’s own cost and expense;

16.5.2 if Almirall succeeds in any such infringement proceedings whether at trial or by way of settlement, Almirall and GW Pharma (if it participates in such proceeding as a co-plaintiff) shall each be entitled to retain such part of any award of costs and damages made in such proceedings or settlement sum as is equal to each Party’s costs of taking the proceedings on a pro rata basis until each Party has been reimbursed its cost of participating in such proceedings, and (a) where GW Pharma has acted as co-plaintiff, the balance of such award of costs and damages shall be shared by the Parties in equal amounts; and (b) where GW Pharma has not acted as co-plaintiff, Almirall shall be entitled to retain the balance of the award received by Almirall less an amount equivalent to *** per cent (***%) of such balance which amount shall be paid to GW Pharma.

16.5.3 if Almirall fails to take any such proceedings, GW Pharma may give Almirall notice requesting Almirall to take such proceedings within thirty (30) days of the date of notice and if Almirall decides not to do so, unless the infringement is taking place in a Major European Market or Almirall informs GW Pharma that Almirall considers in its sole discretion that to take such proceedings would be prejudicial to its litigation strategy in the Major European Markets, GW Pharma shall be entitled to do so at its own cost and

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expense in which case it shall have sole conduct of any claim or proceedings including any counterclaim for invalidity or unenforceability or any declaratory judgment action. Almirall shall provide all necessary assistance to GW Pharma in relation to such proceedings and GW Pharma shall on demand by Almirall indemnify Almirall against the Costs of such activity, unless Almirall elects to be separately represented (which shall be at Almirall’s discretion), in which case such separate representation shall be at Almirall’s cost and expense. GW Pharma shall have sole right to settle such proceedings including any counterclaim for invalidity or unenforceability, provided that such settlement does not include a licence under the relevant Almirall IP. If GW Pharma succeeds in any such proceedings it shall be entitled to retain the whole of any award of costs and damages made or settlement sum paid.

16.6 In the event that Almirall or GW Pharma reasonably believe that Almirall or any of its Affiliates or Distributors might infringe by the conduct of Commercialisation of Product in the Territory the *** with numbers *** shall be responsible for taking a license or otherwise defending and filing any claim or proceeding based on such Third Party Patent Rights in the Territory *** Almirall against any award for damages made against Almirall as a result of such claim. Moreover, in the event that GW Pharma or Almirall become aware of any Patent Rights of a Third Party ***, which it reasonably believes that Almirall, GW Pharma or any of their Affiliates or Distributors might infringe by the conduct of the Commercialisation of Product in the Territory, GW Pharma shall in its discretion be responsible as between GW Pharma and Almirall for taking a licence or otherwise defending and filing any claim or proceeding based on Third Party Patent Rights in the Territory on such terms as it may in its sole discretion determine and at its sole cost and expense and liability.

16.7 Each Party shall promptly take all necessary steps to facilitate the other’s application (made either on the other’s own initiative or upon request by the first Party) for extensions to the term of Patent Rights, including applications for supplementary protection certificates and patent term extensions.

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16.8 The Parties agree to cooperate in an effort to avoid loss of any GW Pharma IP which may otherwise be available to the Parties hereto including by executing any documents as may be reasonably required. In particular, the Parties shall cooperate with each other in obtaining patent term restoration or SPC or their equivalents in any country and region where applicable.

16.9 According to this Clause 16, the fact that Almirall may act, prosecute and defend any GW Pharma IP (including Trademarks) related to the Products referred to this Agreement will not imply itself that Almirall acquires any right or right to use any of the GW Pharma IP beyond such rights of use as are expressly granted in this Agreement.

17. CONFIDENTIALITY AND NON-DISCLOSURE

17.1 Confidential Information shall not include any information that:

17.1.1 is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of the party in possession of or receiving the Confidential Information (“Receiving Party”);

17.1.2 can be demonstrated by documentation or other competent proof to have been in the Receiving Party’s or its Affiliates’ possession prior to disclosure by the party disclosing the Confidential Information (“Disclosing Party”). Almirall shall be treated as the Disclosing Party in respect of any Almirall IP, GW Pharma shall be treated as the Disclosing Party in respect of any GW Pharma IP;

17.1.3 is subsequently received by the Receiving Party or its Affiliates from a Third Party who is not bound by any obligation of confidentiality with respect to the said information;

17.1.4 is generally made available to Third Parties by the Disclosing Party without restriction on disclosure and not in breach of this Agreement; or

17.1.5 following the Term is independently developed by or for the Receiving Party or its Affiliates without reference to the Disclosing Party’s Confidential Information.

Specific aspects or details of Confidential Information shall not be deemed to be within the public domain or in the possession of the Receiving Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the Receiving Party. Further, any combination of Confidential Information shall not be considered in the public domain or in the possession of the Receiving Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the Receiving Party unless the combination and its principles are in the public domain or in the possession of the Receiving Party.

17.2 At all times during the Term and subject to the provisions of Clause 17.3, each Party shall, and shall cause its officers, directors, employees, consultants, Affiliates and sub-licensees to, keep confidential and not publish or otherwise disclose and not use, directly or indirectly, for any purpose, any Confidential Information, except to the extent such disclosure or use is expressly permitted by the terms of this Agreement or is reasonably necessary for the performance of this Agreement or is reasonably required as a matter of practice, for example, the placing of details of a clinical trial or clinical data on a web-site.

17.3 Each Party may disclose Confidential Information to the extent that such disclosure is:

17.3.1 made in response to a valid order of a court of competent jurisdiction or other competent authority; provided, however, that the Party shall first have given notice to the other Party and given the other Party a reasonable opportunity to quash any such order or obtain a protective order requiring that the Confidential Information and Documents that are the subject of such order be held in confidence by such court or authority or, if disclosed, be used only for the purpose for which the order was issued; and provided further that if such order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order shall be limited to that information that is a Legal Requirement to be disclosed in response to such court or governmental order;

17.3.2 made by a Party or its Affiliates to a Regulatory Authority as may be necessary or useful in connection with any filing, application or request for a Marketing Authorisation; provided, however, that reasonable measures shall

be taken to assure confidential treatment of such information, to the extent such protection is available;

17.3.3 made by the Party to a patent authority as may be necessary or useful for purposes of obtaining or enforcing a Patent Right (consistent with the terms and conditions of Clause 16); provided, however, that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available;

17.3.4 otherwise required by law, regulation or established procedure, provided, however, that the Party shall (a) provide the other Party with reasonable advance notice of and an opportunity to comment on any such required disclosure, (b) if requested by the other Party, seek confidential treatment with respect to any such disclosure to the extent available, and (c) use good faith efforts to incorporate the comments of the other Party in any such disclosure or request for confidential treatment. Notwithstanding the foregoing, in the event that either Party is required by Legal Requirement or the requirements of a national securities exchange or another similar regulatory body to disclose Confidential Information, in whole or in part, the Parties shall use their best efforts to limit such disclosure to the extent necessary; or

17.3.5 made by a Party or its Affiliates or in the case of GW Pharma to its distributors, sub-licensees or Third Parties as may be necessary or useful in connection with the Development or Commercialisation of Product as contemplated by this Agreement, including subcontracting transactions in connection therewith; or

17.3.6 the general nature of the activities being performed under this Agreement and the relationship of the Parties under this Agreement: (A) to its actual or potential financial advisors and to lenders in connection with obtaining financing for its business, where each such potential financial advisor or lender prior to disclosure is bound by obligations of confidentiality that prohibit any further disclosure (except to lawyers acting on behalf of such investment bankers or lenders), and by obligations of non-use that permit use only for purposes of providing financing to that Party, (B) to potential venture capital or other investors in connection with a private placement of securities

for purposes of obtaining financing for its business, where each such potential venture capital investor prior to disclosure is bound by obligations of confidentiality that prohibit any further disclosure (except to lawyers acting on behalf of such venture capital investor), and by obligations of non-use that permit use only for purposes of providing financing to the that Party, or (C) to its advisors and consultants, where each such advisor or consultant prior to disclosure is bound by obligations of confidentiality that prohibit any further disclosure, and by obligations of non-use that permit use only for purposes of providing services to the disclosing Party that are activities consistent with this Agreement; or (D) such disclosure is required or advisable with regard to the disclosure requirements of the U.S. Securities and Exchange Commission or the national securities exchange or other stock market or of a related regulatory body on which such Party’s securities are or are proposed to be traded; or (E) such disclosure is to potential M&A partners or potential marketing/distribution partners and their advisors where each such M&A partner, marketing/distribution partner or advisor prior to disclosure is bound by obligations of confidentiality that prohibit any further disclosure.

17.4 Neither Party shall mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in any publications, press release, promotional material or other form of publicity without the prior written consent of the other Party in each instance (which shall not be unreasonably withheld or delayed), except for those disclosures for which consent has previously been obtained. The restrictions imposed by this Clause 17.4 shall not prohibit either Party from making any disclosure identifying the other Party that is required by Legal Requirement or the requirements of a national securities exchange or another similar regulatory body, provided that any such disclosure shall be governed by this Clause 17.4.

17.4.1 Notwithstanding the foregoing, either Party shall be entitled to include the name of the other Party within a published list of collaborators.

17.4.2 Notwithstanding the foregoing, each Party shall have the right to use the name of the other party and the Products to the extent necessary or useful in connection with the Development or Commercialisation of Product as

contemplated by this Agreement, including subcontracting transactions in connection therewith.

17.5 Other than the press releases pertaining to this transaction that the Parties have agreed upon and attached as Schedule 5 to this Agreement, neither Party shall issue any press release or make any other public announcement or statement concerning this Agreement or its terms without the prior written approval of the other Party, except that each Party (after consultation with counsel and after informing the other Party) may make such announcements and disclosures, if any, as may be required by Legal Requirement or the requirements of a national securities exchange or another similar regulatory body, or in connection with a public offering of securities or any filing with the U.S. Securities and Exchange Commission or a foreign equivalent. Further a Party, without obtaining prior written consent of the other Party, may disclose the terms of this Agreement (limited or redacted, as applicable, to the extent reasonably possible)in the same circumstances as are set out in Clause 17.3.6 (A) through (E).

17.6 If a Party’s approval is required for a proposed Confidential Information or Agreement disclosure, then the Party from which approval is being required will have no less than five (5) business days to review and provide comment regarding any such proposed disclosure, unless a shorter review time is agreed.

18. WARRANTIES AND UNDERTAKINGS

18.1 Each Party warrants to the other Party that:

18.1.1 it has legal power, authority and right to enter into this Agreement and to perform its respective obligations in this Agreement;

18.1.2 it is not at the Effective Date a party to any agreement, arrangement or understanding with any Third Party which in any significant way prevents it from fulfilling any of its material obligations under the terms of this Agreement;

18.1.3 it is not aware of any governmental proceedings or sanction which could prevent it from fulfilling any of its material obligations under the terms of this Agreement; and

18.1.4 it has disclosed to the other all information and material which is material to the decision of the other to enter into this Agreement.

18.2 GW Pharma warrants to Almirall that GW Pharma is sole owner of GW Pharma IP with the right to grant to Almirall the rights which are granted in this Agreement, free and clear of any liens or encumbrances which would prevent the grant of such rights.

18.3 To the best of its knowledge, GW Pharma warrants to Almirall that the trademark Sativex is registered in the countries in the Territory listed in Schedule 4.

18.4 Almirall warrants to GW Pharma that Almirall is the sole owner of Almirall IP with the right to grant to GW Pharma the rights which are granted in this Agreement, free and clear of any liens or encumbrances which would prevent the grant of such rights.

18.5 GW Pharma warrants to Almirall that as at the Effective Date and so far as GW Pharma is aware, there are no actual or threatened proceedings relating to infringement of third party intellectual property rights by the use of GW Pharma IP and, and further represents and warrants that the GW Pharma IP is not the subject of any actual or threatened challenge or revocation proceedings.

18.6 GW Pharma warrants to Almirall that as at the Effective Date so far as GW Pharma is aware, GW Pharma has the right to grant to Almirall the exclusive right to Commercialise and distributed GW Pharma Products and other rights granted under this Agreement.

18.7 Save as is expressly stated in Clauses 18.1, 18.2, 18.4, 18.5, 18.5 and 18.6 no representation, condition or warranty whatsoever is made or given by or on behalf of Almirall or GW Pharma. All conditions and warranties whether arising by operation of law or otherwise are hereby expressly excluded including any conditions and warranties to the effect that:

18.7.1 any of the GW Pharma Patents Rights are valid or enforceable; or

18.7.2 any of the acts to be undertaken by Almirall or GW Pharma pursuant to this Agreement will not infringe the rights of third parties.

18.8 GW Pharma shall have control of Clinical Trials conducted under the Development Plan and Lifecycle Management Plan and in such capacity shall be responsible for the payment of any compensation due to any participants in such trials who suffer death or bodily injury pursuant to any legal rights or applicable industry guidelines. Almirall shall have control of Marketing Studies conducted under the Commercialisation Plan and in such capacity shall be responsible for the payment of

any compensation due to any participant in such trials who suffer death or bodily injury pursuant to any legal rights or applicable industry guidelines.

19. INDEMNIFICATION AND INSURANCE

19.1 In addition to any other remedy available to GW Pharma, subject to Clauses 19.3 and 19.4, Almirall shall indemnify, defend and hold harmless GW Pharma, its Affiliates and its and their respective directors, officers and employees in full and on demand, from and against any and all Losses incurred by them to the extent resulting from or arising out of or in connection with any claims made or suits brought by a Third Party (collectively, “GW Pharma Third Party Claims”) against GW Pharma, its Affiliates or their respective directors, officers or employees that allege that the claimant has suffered personal injury or death as a result of any activity undertaken by Almirall or its Affiliates either directly or indirectly pursuant to this Agreement except for any Losses for which GW Pharma has an obligation to indemnify Almirall and its Affiliates pursuant to Clause 19.2.

19.2 In addition to any other remedy available to Almirall, subject to Clause 19.3 and 19.4, GW Pharma shall indemnify, defend and hold harmless Almirall, its Affiliates, and its and their respective directors, officers and employees in full and on demand, from and against any and all Losses incurred by them to the extent resulting from or arising out of or in connection with any claims or suits brought by a Third Party (collectively, “Almirall Third Party Claims”) against Almirall, its Affiliates or their respective directors, officers or employees that allege that the claimant has suffered personal injury or death as a result of any activity undertaken by GW Pharma or its Affiliates either directly or indirectly pursuant to this Agreement or in respect of the use of Product marketed and sold by Almirall or its Affiliates (in accordance with the label and patient information leaflet) only when and to the extent such use is or has been the cause of such personal injury or death, except in either case for any Loss for which Almirall has an obligation to indemnify GW Pharma and its Affiliates pursuant to Clause 19.1.

19.3 An indemnified person under Clauses 19.1 or 19.2 (“Indemnified Party”) shall give the indemnifying party under Clauses 19.1 or 19.2 (“Indemnifying Party”) prompt written notice of any Loss or discovery of fact upon which such Indemnified Party intends to base a request for indemnification under Clause 19.1 or 19.2 (an

“Indemnification Claim Notice”). Where required the Indemnifying Party shall promptly send a copy of the Indemnification Claim Notice to its relevant insurers and shall permit them to exercise their rights of subrogation and hereafter in this Clause 19 “Indemnifying Party” shall be deemed to include any such insurers. In no event shall the Indemnifying Party be liable for any Loss that results from any delay in providing the Indemnification Claim Notice. Each Indemnification Claim Notice shall contain a description of the claim and the nature and amount of the Loss claimed (to the extent that the nature and amount of such Loss is known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all correspondence, communications and official documents (including court documents) received in respect of any such Loss. For the avoidance of doubt, all indemnification claims in respect of a Party, its Affiliates or their respective directors, officers, employees and agents (each, an “Indemnitee”) shall be made solely by a Party to this Agreement or its insurers.

19.4 The obligations of an Indemnifying Party under this Clause 19 shall be governed by and contingent upon the following:

19.4.1 At its option, the Indemnifying Party may assume control of the defense of any Third Party Claim (which, for the avoidance of doubt, shall include the conduct of all dealings with such Third Party) by giving written notice to the Indemnified Party within fourteen (14) days after the Indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of control of the defense of a Third Party Claim by the Indemnifying Party shall not be construed as an acknowledgement that the Indemnifying Party is liable to indemnify any Indemnitee in respect of the Third Party Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification.

19.4.2 Upon the assumption of the control of the defence of a Third Party Claim by the Indemnifying Party:

(a) subject to the provisions of Clause 19.4.3, it shall have the right to and shall assume sole control and responsibility for dealing with the Third Party and the Third Party Claim, including the right to settle the claim on any terms the Indemnifying Party

chooses, but at all times in accordance with the provisions of Clause19.4.4;

(b) if it chooses, the Indemnifying Party may appoint as counsel in the defence of the Third Party Claim any law firm or counsel selected by the Indemnifying Party; and

(c) except as expressly provided in Clause19.4.3, the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party or any Indemnitee in connection with the analysis, defence or settlement of the Third Party Claim. In the event that it is ultimately determined that the Indemnifying Party is not obligated to indemnify, defend or hold harmless an Indemnitee from and against the Third Party Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all costs and expenses (including lawyers’ fees and costs of suit) and any Losses incurred by the Indemnifying Party in its defence of the Third Party Claim with respect to such Indemnified Party or Indemnitee.

19.4.3 Without limiting Clause 19.4, any Indemnitee shall be entitled to participate in, but not control, the defence of a Third Party Claim by having its views regularly solicited by the Indemnifying Party and, where proceedings are commenced, to retain counsel of its choice for such purpose; provided, however, that such retention shall be at the Indemnitee’s own expense unless, (a) the Indemnifying Party has failed to assume the defence and retain counsel in accordance with Clause 19.4.1 (in which case the Indemnified Party shall control the defence), or (b) the interests of the Indemnitee and the Indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under Legal Requirement, ethical rules or equitable principles.

19.4.4 With respect to any Losses relating solely to the payment of money to the Third Party to settle the Third Party Claim and that will not result in the Indemnified Party or the Indemnitee becoming subject to injunctive relief,

and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnitee under Clause 19.4.1, the Indemnifying Party shall have the sole right to enter into any such settlement including any consent judgment, on such terms as the Indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Losses or where the Indemnified Party will be subject to injunctive relief, where the Indemnifying Party has assumed the defence of a Third Party Claim in accordance with Clause 19.4.1, the Indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Losses, provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld or delayed).

19.4.5 If the Indemnifying Party chooses not to take control of the defence or prosecute any Third Party Claim, the Indemnified Party shall retain control of the defense thereof but no Indemnified Party or Indemnitee shall admit any liability with respect to, or settle, compromise or discharge, any such Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld. The Indemnifying Party shall not be liable for any settlement or other disposition of Losses by an Indemnified Party or an Indemnitee under such a Third Party Claim that is reached without the written consent of the Indemnifying Party.

19.4.6 If the Indemnifying Party chooses to control the defence of any Third Party Claim, the Indemnified Party shall, and shall cause each other Indemnitee to, reasonably cooperate in the defense thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making the Indemnified Party, the Indemnitees and its and their employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided, and the

Indemnifying Party shall reimburse the Indemnified Party for all of its related reasonable out-of-pocket expenses.

19.4.7 Except as expressly provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party where it participates in the defence under Clause 19.4.3 or Clause 19.4.5 shall be reimbursed on a Quarterly basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

19.5 Except with respect to Third Party claims under Clauses 19.1 or 19.2, neither Party shall be liable to the other in contract, tort, negligence, breach of statutory duty or otherwise for any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by the other or its Affiliates:

19.5.1 of a direct nature where the same is a loss of turnover, profits, business or goodwill; or

19.5.2 an indirect or consequential or punitive nature, including any indirect or consequential economic loss or other indirect or consequential loss of turnover, profits, loss of enterprise value, business or goodwill or otherwise.

Nothing in this Agreement shall be taken to exclude or limit either Party’s liability to the extent that such liability cannot be excluded or limited in law including for fraud or fraudulent misrepresentation.

19.6 Each Party shall have and maintain such type and amounts of liability insurance as is normal and customary in the pharmaceutical industry generally for persons similarly situated, and shall upon request provide the other Party with a copy of its policies or certificates of insurance (as available) in that regard, along with any amendments and revisions thereto. Notwithstanding the foregoing, as a minimum, each Party shall maintain during any period in which Almirall is Commercialising a Product or Party has indemnification obligations to the other, which indemnification obligations shall be scheduled in the policies or notified to that Party’s insurers (as applicable) (a) commercial general liability insurance with a combined single limit for bodily injury

and property damage of not less than £*** and (b) products liability with a minimum indemnity limit of €*** per occurrence to an aggregate liability in any year of €***. Such policies shall (i) be provided by insurance carrier(s) reasonably acceptable to the other Party, and (ii) be written on a claims made basis. Such policies shall remain in effect throughout the Term and for five (5) years thereafter and shall not be cancelled or subject to a reduction of coverage without the prior written authorisation of the other Party.

19.7 In the event of any conflict or overlap between the provisions of this Clause 19 and the provisions of Clause 16, the provisions of Clause 16 shall in all cases prevail.

20. TERMINATION

20.1 Subject to the other provisions of this Clause 20 this Agreement shall come into force on the Effective Date and expire on a country-by-country basis on the later of: (a) the expiry of the last to expire Valid Claims of GW Pharma Patent Rights directly Covering Product in that Country; or (b) on the fifteenth anniversary of Launch (the “Initial Term”). Following the Initial Term, the Agreement shall continue for successive periods of one (1) year thereafter unless Almirall terminates the Agreement by giving GW Pharma at least one (1) years written notice to expire at the end of any Calendar Year (the “Extended Term”) (the Initial Term and the Extended Term being the “Term”).

20.2 Each of the Parties (“the Terminating Party”) shall have the right to terminate this Agreement for cause with immediate effect upon giving written notice of termination to the other (“the Defaulting Party”) upon the occurrence of any of the following events at any time during this Agreement:

20.2.1 the Defaulting Party commits a material breach of this Agreement which breach shall not have been remedied within ninety (90) days of the receipt by it of a written notice from the other Party identifying the breach and requiring its remedy;

20.2.2 if an Insolvency Event occurs in relation to the Defaulting Party. In any event when a Party first becomes aware of the likely occurrence of any

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Insolvency Event in regard to that Party, it shall promptly so notify the other Party in sufficient time to give the other Party sufficient notice to protect its interests under this Agreement.

20.3 Almirall shall have the right at any time during the Initial Term to give notice of termination of this entire Agreement by notice in writing to GW Pharma if in Almirall’s sole opinion Almirall decides not to proceed with this entire Agreement for whatever reason, such reason being specified in the notice for the sole purpose of information. Where Almirall gives a notice of termination pursuant to Clause 20.3, the relevant notice period shall be six (6) months where Almirall is not Commercialising Product anywhere in the Territory and otherwise shall be twelve (12) months. For clarity, all payments made to GW Pharma prior to expiry of the relevant notice period under this Clause 20.3 shall be non-refundable but Almirall may exercise its option to terminate this Agreement under this Clause 20.3 without any liability to GW Pharma, save that (i) Almirall shall be liable to make the payments which become due and payable prior to the effective date of termination (expiry of the relevant notice period) under Clauses 11.7 to 11.9 or which have otherwise become due and payable prior to the effective date of termination (expiry of the relevant notice period) but which have not yet been paid, and (ii) in the event Almirall (a) was in material breach of this Agreement prior to giving notice under this Clause 20.3 or (b) commits a material breach of this Agreement between giving notice to terminate the Agreement under this Clause 20.3 and the expiry of the relevant notice period, and in either case GW Pharma has provided Almirall with written notice alleging such material breach of the Agreement under Clause 20.2, GW Pharma shall have all applicable remedies available to it including the right to claim damages.

21. CONSEQUENCES OF TERMINATION

21.1 Exclusively in case of termination of this Agreement by GW Pharma pursuant to Clause 20.2 (for cause) or by reason of Clauses 23.1 or by Almirall pursuant to Clause 20.1 or Clause 20.3 (which in each case the Parties agree shall not terminate the provisions of this Agreement expressed to survive its termination) Almirall shall:

21.1.1 grant to GW Pharma an exclusive, world-wide sub-licensable license under any Almirall IP that is necessary to Commercialise and have Commercialised

Products and to use Almirall Confidential Information that relates specifically to Product as necessary for this purpose. Almirall shall do all such acts and things as may be necessary to perfect this obligation.

21.1.2 deliver up to GW Pharma any Know How and/or Materials comprised in Almirall IP or GW Pharma IP in its Control;

21.1.3 deliver up to GW Pharma any and all quantities of Product in its possession, power, custody or control subject always to Almirall’s right to sell Product which is the subject of pre-termination date orders;

21.1.4 have no further rights to commercialise and distribute Products in the Territory under GW Pharma IP and Trademark under this Agreement (with the effect that all deriving rights granted by Almirall to any Third parties shall automatically cease) and shall not after the date of termination itself use, or otherwise exploit Almirall IP which relates solely to Product or the GW Pharma IP, except that in the case of a Commercialised Product Almirall has the right to sell that part of its inventory of Product on hand as of the effective date of termination which is the subject of orders for Product accepted prior to the effective date of termination for a period of twelve (12) months after the effective date of termination, and, within sixty (60) days after disposition of such inventory pursuant to the fulfilment of such orders, Almirall will forward to GW Pharma a final report and pay all outstanding amounts due.

21.1.5 continue to fund to completion any Clinical Trial or Marketing Study ongoing at the date of termination which Almirall is liable to fund (in whole or in part) under the terms of this Agreement.

21.2 Upon the termination of this Agreement by Almirall pursuant to Clause 20.2 (termination for cause) the rights and licenses granted to Almirall hereunder shall continue to apply and Almirall shall, without prejudice to its other rights, hereunder or at law, be entitled to seek damages or enforce judgment against GW Pharma, have the right to set off against its continuing payment obligations to GW Pharma any award of damages granted to Almirall by a competent court or arbitral body. For clarity, until Almirall elects to terminate its obligation to obtain its requirements of Product from GW Pharma pursuant to Clause 21.2.2, GW Pharma shall continue to supply Almirall

with Product on the terms of this Agreement (including the applicable Supply Price); and

21.2.1 GW Pharma shall continue to prosecute, maintain and defend the GW Pharma Patent Rights and Trademarks as specified in Clauses 14 and 16;

21.2.2 Almirall shall have the right exercisable in its discretion to terminate its obligation to obtain its requirements of Product from GW Pharma under this Agreement and the corresponding manufacturing and supply provisions of this Agreement on giving 30 days written notice to GW Pharma and Almirall’s right and license under Clause 2.1 shall include the right to manufacture Product on the following terms:

(i) Almirall shall have the right either to manage that stage of the manufacture currently undertaken by GW Pharma or by one or more sub-contractors of GW Pharma or alternatively assume the manufacture itself of that part of the manufacturing process and Almirall shall assume the right to manufacture, subject to appropriate Regulatory Authority approvals being obtained;

(ii) depending on whether Almirall has partial or total responsibility, GW Pharma shall become a contractor to Almirall in respect of the first stage of the manufacturing process and if necessary, at Almirall’s request GW Pharma shall assign its contracts with its sub-contractors to Almirall;

(iii) the licence to manufacture Product pursuant to Clause 2.1 shall be a sole licence in the Territory as between GW Pharma and Almirall;

(iv) during the period of manufacture by Almirall the Supply Price shall be adjusted by good faith negotiation between the Parties enabling GW Pharma to receive payment for sales of Product based on the Supply Price but subject to deduction of Almirall’s costs of manufacture so as to reflect the reasonable Costs of Manufacture incurred by Almirall under the revised manufacturing arrangements required to fulfil Almirall’s sales volumes of the Product for the Territory, and GW Pharma’s costs relating to the manufacture of the Product previously included by GW Pharma within the Supply Price.

(v) GW Pharma shall give reasonable assistance to Almirall in transferring manufacturing to such location or Third Party as Almirall shall nominate on terms of confidence, including reasonable assistance with transferring that GW Pharma Know How necessary for manufacture provided that such Third Party shall be obliged to maintain the same degree of confidentiality as Almirall under this Agreement.

21.2.3 GW Pharma shall continue to maintain efficiently all Marketing Authorisations for the Territory and shall not materially amend any such Marketing Authorisation without the prior written consent of Almirall (which consent shall not be unreasonably withheld or delayed). Should GW Pharma fail to maintain the Marketing Authorisation efficiently Almirall may, in its discretion, request that GW Pharma appoint a regulatory agent acceptable to both Parties to maintain the Marketing Authorisations on GW Pharma’s behalf. Such agent shall be appointed at GW Pharma’s cost and expense and GW Pharma hereby undertakes to cooperate with such agent in the maintenance of the Marketing Authorisations.

21.3 Save as may be expressly specified otherwise in this Agreement the provisions of Clauses 14, 16, 17, 19, 21 and 27 shall survive termination of this Agreement.

22. FORCE MAJEURE

22.1 If a Party (the “Affected Party”) is unable to carry out any of its obligations under this Agreement due to Force Majeure this Agreement shall remain in effect but the Affected Party’s relevant obligations under this Agreement and the corresponding obligations of the other Party (“Non-Affected Party”) under this Agreement, shall be suspended for a period equal to the circumstance of Force Majeure provided that:

22.1.1 the suspension of performance is of no greater scope than is required by the Force Majeure;

22.1.2 the Affected Party immediately gives the Non-Affected Party prompt written notice describing the circumstance of Force Majeure, including the nature of the occurrence and its expected duration, and continues to furnish regular reports during the period of Force Majeure and notifies the Non-Affected Party immediately of the cessation of the Force Majeure;

22.1.3 the Affected Party uses all reasonable efforts to remedy its inability to perform and to mitigate the effects of the circumstance of Force Majeure; and

22.1.4 as soon as practicable after the event which constitutes Force Majeure the Parties discuss how best to continue their operations as far as possible in accordance with this Agreement.

22.2 If the circumstance of Force Majeure prevails for a continuous period in excess of six (6) months the Non-Affected Party may, without prejudice to any other rights or remedies which may be available to it, terminate this Agreement with immediate effect by giving written notice of termination to the other Party. For clarity where the Force Majeure applies to a specific country or group of countries in the Territory the Non-Affected Party may terminate this Agreement with immediate effect by giving written notice of termination to the other solely with regard to the affected country or countries. In the event of termination of the whole or any part of this Agreement under this Clause 22, the provisions of Clause 21 shall not apply and the Parties shall meet to discuss the consequences of termination pursuant to this Clause 22.

23. CHANGE OF CONTROL

23.1 Each Party (the “Acquired Party”) shall provide written notice to the other of an impending Change of Control of the Acquired Party or the Acquired Party’s parent and the details of the acquirer (“New Owner”) as soon as the Change of Control can be legally disclosed.

23.2 Within thirty (30) days of a Change of Control of the Acquired Party being disclosed, the other Party (the “Requesting Party”) may request from the New Owner confirmation in writing that it assumes in full the obligations and rights of the Acquired Party hereunder. In the event that the Requesting Party does not receive such confirmation within thirty (30) days of submitting its request therefor, the Requesting Party may terminate this Agreement with immediate effect upon giving written notice to the Acquired Party.

23.3 Save where there is a Significant Event (in which case Almirall shall be relieved of its obligations hereunder for the duration of that event) in the event that following a

Change of Control of Almirall, Almirall does not achieve in any one of the next *** years from the Change of Control total sales of Product in the Territory equal to or greater *** percent (***%) of those sales achieved by Almirall in the *** months immediately prior to the Change of Control, all rights and licences granted to Almirall hereunder shall become non-exclusive with immediate effect upon GW Pharma giving written notice to Almirall.

23.4 Save where there is a Significant Event (in which case Almirall shall be relieved of its obligations hereunder for the duration of that event) in the event that following a Change of Control of Almirall, Almirall does not achieve in any one of the *** years from the Change of Control total sales of Product in the Territory equal to or *** percent (***%) of those sales achieved by Almirall in the *** months immediately prior to the Change of Control, GW Pharma may terminate this Agreement with immediate effect upon giving written notice to Almirall.

24. ASSIGNMENT

24.1 This Agreement and the rights herein granted shall be binding upon and inure to the benefit of the successors in interest of the respective Parties. Neither this Agreement nor any interest hereunder shall be assignable by either Party without the written consent of the other (such consent not to be unreasonably withheld or delayed) provided, however, and subject always to Clause 23.1 that either Party may assign this Agreement or any part of its rights and obligations hereunder, or any Patent Rights owned by it, to any Affiliate or to any corporation with which such Party may merge or consolidate, or to which it may transfer all or substantially all of its assets without obtaining the consent of the other Party.

25. GOVERNING LAW

The interpretation and construction of this Agreement shall be governed by the laws of England excluding any conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction.

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26. ARBITRATION

26.1 All disputes arising between the Parties with respect to or as a result of this Agreement shall be resolved by arbitration before a three member panel pursuant to the rules of the International Chamber of Commerce. Such proceedings shall be brought and maintained in London, England if initiated by Almirall and in Barcelona, Spain, if initiated by GW Pharma. Of the three arbitrators one shall be nominated by GW Pharma, one shall be nominated by Almirall and the third shall be nominated by the two arbitrators nominated by the Parties.

26.2 A majority decision of the arbitrators will suffice for any award. The arbitrator’s award shall make provision for the costs of the arbitration to be paid by the Parties in such proportions as the arbitrators decide is appropriate. Any reference under this Clause 26 shall be deemed to be a reference to arbitration within the meaning of the Arbitration Act 1996.

26.3 Notwithstanding the foregoing, either Party shall have the right, without waiving any right or remedy available to such Party under this Agreement or otherwise, to seek and obtain from any court of competent jurisdiction any interim or provisional relief that is necessary or desirable to protect the rights or property of such Party, pending the selection of the arbitrators hereunder or pending the arbitrator’s determination of any dispute hereunder.

27. NOTICES

27.1 Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by a postal delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Clause 27.2 or to such other address as the Party to whom notice is to be given may have provided to the other Party in accordance with this Clause 27. Such notice shall be deemed to have been given as of the date delivered if sent by hand or post or as of the date transmitted if sent by facsimile (with transmission confirmed). Any notice delivered by facsimile shall be confirmed by a hard copy delivered as soon as practicable thereafter. This Clause 27 is not intended to govern the day-to-day business

communications necessary between the Parties in performing their obligations under the terms of this Agreement.

27.2 Address for Notice

	For:	GW Pharma
	Address:	Porton Down Science Park
		Salisbury,
		Wiltshire
		SP4 0JQ
		United Kingdom

	Fax number:	+44 1980 557111

	For the attention of:	Managing Director

	For:	Almirall
	Address:	General Mitre 151
		08022 Barcelona
		Spain

	Fax number:	+34 93 291 3560
	For the attention of:	General Counsel

28. RELATIONSHIP OF THE PARTIES

The status of a Party under this Agreement shall be that of an independent contractor. Nothing contained in this Agreement shall be construed as creating a partnership, joint venture or agency relationship between the Parties or, except as otherwise expressly provided in this Agreement, as granting either Party the authority to bind or contract any obligation in the name of or on the account of the other Party or to make any statements, representations, warranties or commitments on behalf of the other Party. All persons employed by a Party shall be employees of such Party and not of the other Party and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party.

29. ENTIRE AGREEMENT AND SEVERABILITY

29.1 This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of this Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter of this Agreement and, in particular, the Initial Agreement. Each Party confirms that it is not relying on any representations, warranties or covenants of the other Party except as specifically set out in this Agreement. Nothing in this Agreement is intended to limit

or exclude any liability for fraud. All Schedules and Exhibits referred to in this Agreement are intended to be and are hereby specifically incorporated into and made a part of this Agreement. In the event of any inconsistency between any such Schedules or Exhibits and this Agreement, the terms of this Agreement shall govern.

29.2 If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then, to the fullest extent permitted by Applicable Law and if the rights or obligations of any Party will not be materially and adversely affected: (a) such provision will be given no effect by the Parties and shall not form part of this Agreement, (b) all other provisions of this Agreement shall remain in full force and effect, and (c) the Parties shall use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Law and achieves, as nearly as possible, the original intention of the Parties. To the fullest extent permitted by Applicable Law, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect.

30. ENGLISH LANGUAGE

This Agreement is written and executed in the English language. Any translation into any other language shall not be an official version of this Agreement and in the event of any conflict in interpretation between the English version and such translation, the English version shall prevail.

31. AMENDMENT

Any amendment or modification of this Agreement must be in writing and signed by authorised representatives of both Parties.

32. WAIVER AND NON-EXCLUSION OF REMEDIES

A Party’s failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy shall not constitute a waiver of that provision, right or remedy or prevent such Party from enforcing any or all provisions of this Agreement and exercising any rights or remedies. To be effective any waiver must be in writing. All rights and remedies are cumulative and do not exclude any other right or remedy provided by law or otherwise available.

33. NO BENEFIT TO THIRD PARTIES

The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights in any other Persons except as otherwise expressly provided in Clause 19 ( indemnity ). The Contracts (Rights of Third Parties) Act 1999 shall not apply to this Agreement. Except as expressly provided in Clause 19 ( indemnity ), no person who is not a party to this Agreement (including any employee, officer, agent, representative or subcontractor of either Party) shall have the right (whether under the Contracts (Rights of Third Parties) Act 1999 or otherwise) to enforce any term of this Agreement which expressly or by implication confers a benefit on that person without the express prior agreement in writing of the Parties, which agreement must refer to this Clause 33.

34. FURTHER ASSURANCE

Each Party shall perform all further acts and things and execute and deliver such further documents as may be necessary or as the other Party may reasonably require to implement or give effect to this Agreement.

35. EXPENSES

Except as otherwise expressly provided in this Agreement, each Party shall pay the fees and expenses of its respective lawyers and other experts and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution and delivery of this Agreement.

36. COUNTERPARTS

This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission shall be as effective as an original executed signature page.

IN WITNESS WHEREOF the Parties have executed this agreement the day and year first above written.

SIGNED by	)

for and on behalf of	)	illegible

ALMIRALL PRODESFARMA, S.A.	)


SIGNED by	)

for and on behalf of	)	illegible

ALMIRALL — PRODESFARMA, S.A.	)


SIGNED by	)

for and on behalf of	)	illegible

GW PHARMA LIMITED	)


SIGNED by	)

for and on behalf of	)	/s/ David Kirk

GW PHARMA LIMITED	)

100

SCHEDULE 1

Agreed Development Plan

***

Principal Indications:

a) ***

b) ***

c) ***

Any New Indication to be developed shall be discussed and agreed in accordance with Clause 7 of the Agreement.

1. Ongoing and Pending Clinical Development Program

Note: All timings stated in this plan are as currently anticipated but may be subject to change according to the Joint Steering Committee.

1.1 Phase III Clinical Trials

a) ***

***:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

101

Study Code, Name &
Phase

Design & Number of patients

Primary & Secondary
Endpoints

Timing

***

***:
***

***

***

***:
-***
***:
-***:

-***
-***

-***:

-***)
-***
-***

-***

-***
-***
-***
-***
-***
-***

-***

-***
-***

-***

***
***

· ***:

Study Code, Name & Phase		Design & Number of patients		Primary & Secondary Endpoints		Timing
* *		*: *		*: -*		* *

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

102

***:
- ***

***
***

***

***:

***

.
-***

-***
-***
-***
-***
-***
-***
-***
- ***

b) ***

· ***:

Study Code, Name &
Phase

Design & Number of patients

Primary & Secondary
Endpoints

Timing

***
***

***

***:

-***.

***
***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

103

***:
-***

***
***

***

***:

-***

- ***

***
***

***:
***

***:
- ***

- ***
-
***

***

***:
-***

***:
-***

-***

***
***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

104

-***

-***

-***

-***
-***
- ***

***:
***

***:

-***

***:

-***

***
***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

105

				-***

				-***

				-***

· ***

Study Code Name & Phase	Design & Number of patients	Primary & Secondary Endpoints	Timing
* *	***	***	* *
* *	***	***	* *
* *	***	***	* *

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

106

c) ***

***

Study Name & Phase		Design & Number of patients		Primary & Secondary Endpoints		Timing
* *		*: * *: - * - * - * ***		*: * * * *: -*		* *

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

107

-***

-***

-***

-***:

-***
-***
-***
-***

-***
-***
-***

- ***

- ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

108

***

1.2 Phase I Clinical Trials

***

***:

1. ***

2. ***

3. ***

Study Name	Design & Number of patients	Primary Endpoints	Timing
***	***	***	* *
***	***	***	* *
***	***	***	* *

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

109

***

2. Preclinical Development Program

***.

Study Name		Timing
***		* *

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

110

3. Manufacturing and CMC activities for the Drug Substance and the Drug Product

***

***:

· ***

***:

***

Activity Name

Timing

***

***

***
***

***
***

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

111

***

Activity Name

Timing

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

112

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

113

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

114

4. Regulatory Activities

***

Activities	Responsibility	Support	Comments
Pre-approval activities
***	***
***	***
***	***
***	***		***
***	***
***	***	***
***	***	***
***	***	***	***
***	***	***	***
Post-approval activities
***	***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

115

***	***	***
***	***	***
***	***	***
***	***	***	***
***	***	***

Holder and Marketer responsibility chart:

RESPONSIBILITY	GW Pharma (Holder)	Almirall (Marketer)	COMMENTS
***	***
***	***	***	***
***	***		***
***	***
***	***		***
***	***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

116

***	***	***	***
***
***	***	***
***	***
*******	***	***
***
***	***
***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

117

SCHEDULE 2

GW Pharma Patent Rights

Title: ***

Country	Application no.	Grant no.	Status
***	***	—	—
***	***	—	***
***	***	—	***
***	***	—	***
***	***	—	***
***	***	—	***

Title: ***

Country	Application no.	Grant no.	Status
*******	*******	—	—
*******	*******	—	*******
*******	*******	—	*******
*******	*******	—	*******
*******	*******	—	*******
*******	*******	—	*******
*******	*******	—	*******

Title: ***

Country	Application no.	Grant no.	Status
*******	*******	—	*******
*******	*******	—	—
*******	*******	—	*******

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

118

Title: ***

Country		Application no.		Grant no.		Status
*******		*******		—		*******

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

119

Title: ***

Country	Application no.	Grant no.	Status
***	***	—	—
***	***	—	***
***	***	—	***

Title: ***

Country	Application no.	Grant no.	Status
***	***	—	***
***	***	—	***

Title: ***

Country		Application no.		Grant no.		Status
***		***		—		—

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

120

SCHEDULE 3

Product Description

1. Pharmaceutical Form

Oromucosal spray.

Solution contained in an amber glass vial fitted with a metering pump delivering 100 microlitres per actuation (spray).

2. Vial Size

5.5 ml and/or 10 ml.

3. Qualitative and Quantitative Composition

Each vial contains:

***

Each 100 microlitre spray contains:

***

Excipients:

1. ***

2. ***

3. ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Signature version

121

SCHEDULE 4

Trademark

Mark: ***

Country	Application/Registration no.	Application Date	Registration Date	Classes	Status
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

122

Mark: ***

Country	Application/Registration no.	Application Date	Registration Date	Classes	Status
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***

Mark: ***

Country	Application/Registration no.	Application Date	Registration Date	Classes	Status
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

123

***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

124

SCHEDULE 5

Agreed Form Press Releases

Embargoed until 0700

12 December 2005

GW Pharmaceuticals plc

(“GW” or “the Company”)

GW AND ALMIRALL ANNOUNCE EUROPEAN DEVELOPMENT AND MARKETING AGREEMENT FOR SATIVEX ®

GW and Almirall Prodesfarma, S.A. (“Almirall”) announce that they have entered into an exclusive agreement for Almirall to market Sativex ® in Europe (excluding the UK).

Sativex is being developed by GW and is a novel prescription pharmaceutical product derived from components of the cannabis plant. Sativex is administered via a spray into the mouth. In April 2005, Canada became the first country in the world to approve Sativex as a prescription medicine.

Under the terms of the agreement, GW has maintained a significant share of long term product revenues whilst benefiting from a £12 million signature fee. In addition, milestone payments are payable on the successful completion of each of the ongoing pivotal Phase III trials, as well as on regulatory approvals and in relation to achievement of sales targets. Including the signature fee, milestones payable under the contract may total up to £46 million.

Almirall is Spain’s largest pharmaceutical company and one of Europe’s leading private pharmaceutical companies, with 2005 sales approaching 1 billion Euros. Almirall is headquartered in Barcelona, and has a staff of over 3,200 people, approximately 500 of whom form part of the R&D team. It is currently present in around 100 countries worldwide and has a portfolio of proprietary and licensed products. The company has a significant presence in Spain, where it is number two by market share, and subsidiary operations in other major European markets, including France, Germany, Italy, Portugal and Belgium. Almirall is currently strengthening its direct presence in Europe and Latin America via affiliates, and is actively looking for in-licensing opportunities to support this strategy, medicines for the Central Nervous System being one of its priority areas.

Sativex is in Phase III trials for the treatment of Multiple Sclerosis symptoms (neuropathic pain and spasticity), neuropathic pain (peripheral and general) and cancer pain. Under the agreement, GW is responsible for completing the development of Sativex for these three indications.

In addition to the three initial target indications, Almirall and GW expect to collaborate on the development of Sativex in other indications. The parties will be discussing potential new indications over the coming months. It is anticipated that Almirall will contribute to the cost of development of new indications.

125

The licensed territory includes the members of the European Union (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. In countries where Almirall has no direct presence at the time of product launch, the companies shall jointly agree the appointment of distribution partners. In such countries, GW may elect to distribute the product itself. In the UK, Sativex is already licensed to Bayer HealthCare.

GW shall be the Marketing Authorisation holder for Sativex. In addition, GW is to be responsible for commercial product supply and will manage the supply of product through a range of contract manufacturing partners, arrangements for which are all in place and being utilised to supply commercial product to Canada.

Following receipt of the signature fee, GW’s financial position has been significantly strengthened, with net cash balances now totalling £22 million.

Dr Geoffrey Guy, Executive Chairman of GW, said: “We are delighted to have entered into this agreement with Almirall. As one of the leading specialist European pharmaceutical companies, Almirall is exactly the profile of partner that we have been seeking for Sativex. We look forward to working together in building a successful long term collaboration and to realising the market potential for Sativex across all its potential indications. GW’s commercial strategy is to maximise the value of Sativex by retaining a significant interest in revenues from product sales whilst at the same time generating sizeable cash payments in the short term to meet GW’s financial requirements. The terms of this agreement reflect the merits of this strategy.”

Dr Jorge Gallardo, President-CEO of Almirall, said: “We are very pleased with this agreement for Sativex with GW Pharmaceuticals. GW has proven to be an innovative company with a strong scientific basis. This partnership represents a step forward for Almirall reinforcing our presence in European markets, and is a key milestone in our aim of offering society innovative medicines to fulfill unmet medical needs. Our challenge is to improve the health and quality of life of patients suffering from MS and other debilitating conditions.”

- Ends -

Notes to editors:

Sativex

Sativex is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).

In Canada, Sativex is approved for the symptomatic relief of neuropathic pain in adults with MS.

Sativex is currently in Phase III trials in Europe for the following indications:

· Spasticity and Neuropathic Pain in MS

· Peripheral and General Neuropathic Pain

· Cancer Pain

About Almirall

Almirall is a consolidated international pharmaceutical company that researches, develops and commercialises its own R&D and licensed specialities with the aim of improving health and quality of life. The therapeutic areas on which Almirall focuses its research resources are related to the

126

treatment of asthma, Chronic Obstructive Pulmonary Disease (COPD), psoriasis and rheumatoid arthritis.

Almirall is to invest 650 million euros in R&D over the next five years. Forecasted total sales in 2005 amount to 946 million euros. Almirall, whose Headquarters are in Barcelona (Spain), has a staff of over 3,200 people, approximately 500 of whom form part of the R&D team.

Almirall is currently present in around 100 countries with its own products and licensed products from other prestigious companies. The company is strengthening its direct presence in Europe and Latin America via affiliates, and is actively looking for in-licensing opportunities to support this strategy, medicines for the Central Nervous System being one of its priority areas.

For more information: www.almirall.es

About GW Pharmaceuticals plc

GW Pharmaceuticals plc is licensed by the UK Home Office to undertake a pharmaceutical research and development program to develop cannabis-based prescription medicines. GW’s shares are publicly traded on AiM, a market on the London Stock Exchange.

Full details of GW and the company’s clinical trials program can be found at www.gwpharm.com. GW’s clinical research program is being carried out by a team of pharmaceutical professionals experienced in drug development and, in particular, the development of plant-based medicines and drug delivery systems.

Enquiries:

GW Pharmaceuticals plc		(12/12/05) + 44 20 7067 0700
Dr Geoffrey Guy, Executive Chairman		(Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Mark Rogerson, Press and PR		+ 44 7885 638810

Weber Shandwick Square Mile		+ 44 20 7067 0700
Kevin Smith

Almirall
Miriam Paris, Corporate Communication		+ 34 93 291 30 00
Gloria Maltas, Corporate Communication

This news release may contain forward-looking statements that reflect GW’s current expectations regarding future events, including the clinical development and regulatory clearance of its products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of clinical studies, including with respect to Sativex and GW’s other products, the uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumers and medical professionals.

127

ALMIRALL AND GW ANNOUNCE EUROPEAN DEVELOPMENT AND MARKETING AGREEMENT FOR SATIVEX ®

THIS MEDICATION IS ALREADY APPROVED IN CANADA FOR THE RELIEF OF NEUROPATHIC PAIN IN ADULTS WITH MULTIPLE SCLEROSIS AND IS CURRENTLY IN PHASE III TRIALS IN EUROPE

Barcelona, December 12 2005 - Almirall and the UK based pharmaceutical company GW Pharmaceuticals announce that they have entered into an exclusive agreement for Almirall to market Sativex ® in Europe.

The licensed territory includes the members of the European Union countries, EU accession countries as well as Switzerland, Norway and Turkey. In the UK, Sativex is already licensed to Bayer HealthCare.

Sativex is being developed by GW and is a novel prescription pharmaceutical product derived from components of the cannabis plant. Sativex is administered via a spray into the mouth. In April 2005, Canada became the first country in the world to approve Sativex as a prescription medicine for neuropathic pain in Multiple Sclerosis (MS). Sativex is a pharmaceutical product standardised in composition, formulation, and dose. Its principal active cannabinoid components are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). In Europe it is in Phase III trials for the treatment of MS symptoms (neuropathic pain and spasticity), neuropathic pain (peripheral and general) and cancer pain. Under the agreement, GW is responsible for completing the development of Sativex for these three indications. In addition to the three initial target indications, Almirall and GW expect to collaborate on the development of Sativex in other indications.

We are very pleased with this agreement for Sativex with GW Pharmaceuticals. GW has proven to be an innovative company with a strong scientific basis. This partnership represents a step forward for Almirall reinforcing our presence in European markets, and is a key milestone in our aim of offering society innovative medicines to fulfill unmet medical

128

needs. Our challenge is to improve the health and quality of life of patients suffering from MS and other debilitating conditions” said Dr Jorge Gallardo, President-CEO of Almirall.

Under the terms of the agreement, GW has maintained a share of long term product revenues whilst benefiting from a £12 million signature fee. In addition, milestone payments are payable on the successful completion of each of the ongoing pivotal Phase III trials, as well as on regulatory approvals and in relation to achievement of sales targets. Including the signature fee, milestones payable under the contract may total up to £46 million.

About Almirall

For more information: www.almirall.es

129

About GW Pharmaceuticals plc

Enquiries:

Almirall
Miriam Paris, Corporate Communication		+ 34 93 291 30 00
Gloria Maltas, Corporate Communication

GW Pharmaceuticals plc		+ 44 1980 557000
Dr Geoffrey Guy, Executive Chairman
Justin Gover, Managing Director
Mark Rogerson, Press and PR		+ 44 7885 638810

Weber Shandwick Square Mile		+ 44 20 7067 0700
Kevin Smith

130

SCHEDULE 6

GW Pharma Plant Variety Rights

Denomination	File no.	Community PVR Grant no.	Grant Date	Expiry Date
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.12

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated 4 TH March 2009

GW PHARMA LTD

and

LABORATORIOS ALMIRALL, S.A.

AMENDMENT NO.1 TO THE PRODUCT

COMMERCIALISATION AND SUPPLY CONSOLIDATED

AGREEMENT DATED

6 TH JUNE, 2006

THIS AMENDMENT AGREEMENT is made the 4 th day of March 2009 (“ Amendment No.1 ”)

BETWEEN:

(1) GW PHARMA LTD , a company organized under the laws of England, whose principal place of business is Porton Down Science Park, Salisbury, Wiltshire, SP4 OJQ, United Kingdom (“ GW Pharma ”); and

(2) LABORATORIOS ALMIRALL, S.A. a company incorporated in Spain whose principal place of business is General Mitre 151, 08022 Barcelona, Spain (“ Almirall ”).

WHEREAS:

(A) GW Pharma and Almirall are parties to the Product Commercialisation and Supply Consolidated Agreement dated 6 June, 2006, as amended and supplemented (the “ Commercialisation and Supply Agreement ”).

(B) The Parties now wish to further amend the terms of the Commercialisation and Supply Agreement as set out herein.

IT IS NOW AGREED AS FOLLOWS:

1. AMENDMENTS

The Parties agree that the provisions of the Commercialisation and Supply Agreement are amended as follows:

1.1 The definition of “Supply Price” in Clause 1.1 is deleted and replaced by the following:

“ Supply Price ” — the price per Unit (calculated on a country by country basis) at which GW Pharma will supply Almirall with Product being:

(i) for the Initial Period, *** per cent (***%) of the Net Selling Price;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(ii) for the period from the end of the Initial Period and until the date on which GW Pharma files with a Regulatory Authority in the first Major European Market an MAA for the use of Product for the Principal Indication of relief of pain associated with cancer (the “ Second Period ”), *** per cent (***%) of the Net Selling Price;

(iii) for the period from the end of the Second Period and until the Launch of Product in the first Major European Market for the Principal Indication of relief of pain associated with cancer, after approval of such Indication in such Major European Market (the “ Third Period ”), *** per cent (***%) of the Net Selling Price except where the Third Period is longer than *** (***) months in which case the Supply Price for the entire Third Period shall be *** per cent (***%) of the Net Selling Price; and

(iv) following the end of the Third Period, *** per cent (***%).”

1.2 Clause 11.2 of the Commercialisation and Supply Agreement is deleted and replaced by the following:

“11.2 Upon shipment of Product to Almirall, GW Pharma shall submit invoices to Almirall, on a country by country basis, as follows:

11.2.1 during the period from Launch to the end of the Calendar Year in which Launch occurs GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the List Price. Thereafter for each Calendar Year or part thereof until the end of the Initial Period, GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, if no sales of the Product have been made in such country during the previous Calendar Year);

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

11.2.2 for each Calendar Year or part thereof during the Second Period GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable);

11.2.3 during the first *** (***) months of the Third Period GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated from time to time for the previous Calendar Year (or List Price, when applicable), subject to adjustment in case that the Third Period is longer that *** (***) months; thereafter for each Calendar Year or part thereof until the end of the Third Period GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable). Upon the Third Period exceeding a duration of *** (***) months, GW Pharma shall reimburse Almirall *** per cent (***%) of the Net Selling Price (or List Price) respectively considered for each country for those Units invoiced to Almirall during the first *** (***) months of the Third Period. This payment shall be made in addition to the payment of any amount payable by GW Pharma pursuant to Clause 11.5 and shall be taken into account in the calculation of the Invoice Income received by GW Pharma in a relevant Calendar Year when performing the reconciliation set out in Clause 11.5.

11.2.4 following the end of the Third Period GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable).

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

The applicable price in any circumstance being the “Invoice Price”. The total amount invoiced in any Calendar Year for manufacturing and supplying Product for a specific country being the Invoice Income. Almirall shall pay each invoice in full within sixty (60) days after the date of invoice. All invoices shall be stated in Euros and payments shall be made in Euros.”

1.3 Clause 11.7.1 of the Commercialisation and Supply Agreement is deleted and replaced by the following:

“11.7.1 *** pounds sterling (£***) upon the Successful Completion of the Relevant Clinical Trial for treatment of spasticity associated with multiple sclerosis; “ Successful Completion of the Relevant Clinical Trial ” shall mean presentation of the Headline Results Document and the fully Quality Controlled tables and listings for the GW Pharma’s Phase III Clinical Trial n° GWSP0604 (being the “ Relevant Clinical Trial ”) for the relief of spasticity associated with multiple sclerosis which show that such clinical trial has successfully met its primary end point set out in the clinical trial protocol for that clinical trial meaning for clarity that such clinical trial has shown a statistically significant difference compared with placebo, provided further that the clinical efficacy results, together with related safety data available at that time, are sufficient for use as a pivotal trial for filing a MAA. It is agreed that if Almirall notifies within five (5) days of receipt of the above mentioned Headline Results Document and fully Quality Controlled tables and listings that in Almirall’s opinion the results and data are not sufficient for use as a pivotal trial for filing a MAA, then it will be considered that Successful Completion of the Relevant Clinical Trial has not been achieved, unless and until such time that GW Pharma and Almirall further agree that a Successful Completion of the Relevant Clinical Trial has been achieved and that the corresponding MAA can be filed.”

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.4 Clauses 11.8.1 to 11.8.4 of the Commercialisation and Supply Agreement are deleted and replaced by the following:

“***

11.8.1 ***

;

11.8.2 ***

;

11.8.3 ***

;

11.8.4 [INTENTIONALLY LEFT BLANK].

***

”

1.5 Clause 11.11 of the Commercialisation and Supply Agreement is deleted and replaced by the following:

“11.11 GW Pharma shall report the occurrence of each Development milestone and each regulatory approval milestone to Almirall and at the same time shall submit to Almirall an invoice for the associated milestone payment. Almirall shall make the milestone payment for which Clause 11.7.1 provides within ten (10) days of receiving such invoice. Almirall shall make the relevant milestone payment for which Clauses 11.7.2 to 11.7.5 and Clause 11.8 provide within thirty (30) days of receiving such invoice. Almirall shall report the occurrence of each milestone under Clause 8.6 and each sales milestone event to GW Pharma within thirty (30) days of its occurrence and at the same time shall make the milestone payment to GW Pharma for which Clauses 8.6 or 11.9 (as applicable) provides.”

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

2. EFFECT

This Amendment No.1 shall be conditional upon the Successful Completion of the Relevant Clinical Trial (as defined above) and shall only become effective upon Successful Completion of the Relevant Clinical Trial (the “ Amendment Effective Date ”). In the event that Successful Completion of the Relevant Clinical Trial has not occurred on or before June 30, 2009, this Amendment No.1 shall be void ab initio without further action on the part of any Party hereto. Likewise, if regulation established in Article 1.3 above in this Amendment No.1 is held to be invalid, illegal or unenforceable (whether totally or partially), then this Amendment No.1 shall also be void ab initio without further action on the part of any Party hereto. In any such event, the Commercialisation and Supply Agreement shall remain in full force and effect on the terms and conditions set forth therein.

3. REPRESENTATIONS AND WARRANTIES

3.1 As of the Amendment Effective Date each Party hereby represents and warrants to the other Party that it (i) has the power and authority and the legal right to enter into this Amendment No.1 and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Amendment No.1 and the performance of its obligations hereunder. This Amendment No.1 has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

4. REFERENCE TO AND EFFECT ON THE COMMERCIALISATION AND SUPPLY AGREEMENT

This Amendment No 1 effects an amendment to the Agreement, in accordance with the terms of Clause 31 of the Commercialisation and Supply Agreement. Upon the Amendment Effective Date each reference in the Commercialisation and Supply Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Commercialisation and Supply Agreement as supplemented hereby. Other than as supplemented by this Amendment No.1 the Commercialisation and Supply Agreement shall be otherwise unchanged.

5. INTERPRETATION

The interpretation and construction of this Amendment No. 1 shall be made in accordance with the terms of the Commercialisation and Supply Agreement and Clauses 25, 26, 30 and 35 of the Commercialisation and Supply Agreement are hereby incorporated by reference. In this Amendment No.1 capitalised words and phrases shall have the same meaning as in the Commercialisation and Supply Agreement except as otherwise set out herein.

6. EXECUTION IN COUNTERPARTS

In Witness Whereof, the Parties have executed this Amendment No.1 on the date first written above.

GW PHARMA LTD		LABORATORIOS ALMIRALL, S.A.


By:	/s/ Justin Gover	By:	/s/ J. Parés
Name:	Justin Gover	Name:	J. Parés
Title:	Managing Director	Title:	Proxy


By:	/s/ David Kirk	By:	/s/ J. Figueras
Name:	David Kirk	Name:	J. Figueras
Title:	Finance Director	Title:	Proxy

Exhibit 10.13

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated July 23, 2010

GW PHARMA LTD

and

ALMIRALL, S.A.

AMENDMENT TO THE PRODUCT

COMMERCIALISATION AND SUPPLY CONSOLIDATED

AGREEMENT DATED

6 TH JUNE, 2006

THIS AMENDMENT AGREEMENT is made the 23 rd day of July 2010 ( “Amendment” )

BETWEEN:

(1) GW PHARMA LTD , a company organized under the laws of England, whose principal place of business is Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom ( “GW Pharma”) ; and

(2) ALMIRALL, S.A. a company incorporated in Spain whose principal place of business is General Mitre 151, 08022 Barcelona, Spain ( “Almirall” ).

WHEREAS:

(A) GW Pharma and Almirall are parties to the Product Commercialisation and Supply Consolidated Agreement dated 6 June, 2006, as amended and supplemented (the “Commercialisation and Supply Agreement” ).

(B) Pursuant to Section 14.1 of the Commercialisation and Supply Agreement Almirall has requested that applications be filed to register the picturemark (logo) detailed herein as a Trademark.

(C) Pursuant to separate assignment documents dated on or about the date hereof Almirall has assigned all its rights and interests in the picturemark (logo) referenced herein, to GW Pharma.

(D) Due to a change in the insurance policy contracted by GW Pharma an adjustment is required to Section 19.6 of the Commercialisation and Supply Agreement.

(E) The Parties now wish to further amend the terms of the Commercialisation and Supply Agreement as set out herein.

IT IS NOW AGREED AS FOLLOWS:

1. AMENDMENTS

The Parties agree that the provisions of the Commercialisation and Supply Agreement are amended as follows:

1.1 The following applications for registered trademarks (the “ Picturemarks ”) are hereby added to Schedule 4 of the Commercialisation and Supply Agreement:

Mark: ***


Country	Application/ Registration No.	Application Date	Registration Date	Classes	Status
***	***	***	***	***	***
***	***	***	—	***	***
***	***	***	—	***	***
***	***	***	—	***	***
***	***	***	—	***	***
***	***	***	—	***	***

1.2 The Parties agree that the Picturemarks are Trademarks for the purposes of the Commercialisation and Supply Agreement and that the logo covered by the Picturemarks together with the Trademark “Sativex” will be deemed to be the “First Trademark” as such term is defined in Section 14.1 of the Commercialisation and Supply Agreement.

1.3 GW Pharma shall be responsible for the further prosecution and maintenance of the Picturemarks, provided that, as established in Section 14.1(iii)(a) of the Commercialisation and Supply Agreement, all costs (including reasonable attorneys’ fees) for filing and prosecuting applications to register and maintaining registration of such Picturemarks in the Territory will be borne by Almirall.

1.4 The Parties agree that Clause 19.6 of the of the Commercialisation and Supply Agreement is hereby amended and restated as follows:

“19.6 Each Party shall have and maintain such type and amounts of liability insurance as is normal and customary in the pharmaceutical industry generally for persons similarly situated, and shall upon request provide the other Party with a copy of its policies or certificates of insurance (as available) in that regard, along with any amendments and revisions thereto. Notwithstanding the foregoing, as a minimum, each Party shall maintain during any period in which Almirall is Commercialising a Product or Party has indemnification obligations

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

to the other, which indemnification obligations shall be scheduled in the policies or notified to that Party’s insurers (as applicable) (a) commercial general liability insurance with a combined single limit for bodily injury and property damage of not less than £*** and (b) products liability insurance with a minimum indemnity limit of €*** per occurrence to an aggregate liability in any year of €***. Alternatively to scheduling its indemnification obligations in the policies, GW Pharma may name Almirall as an additional insured by endorsement under its product liability insurance policy. Such policies shall (i) be provided by insurance carrier(s) reasonably acceptable to the other Party, and (ii) be written on a claims made basis. Such policies shall remain in effect throughout the Term and for five (5) years thereafter and shall not be cancelled or subject to a reduction of coverage without the prior written authorisation of the other Party.”

2. REPRESENTATIONS AND WARRANTIES

2.1 As of the date of this Amendment each Party hereby represents and warrants to the other Party that it (i) has the power and authority and the legal right to enter into this Amendment and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Amendment and the performance of its obligations hereunder. This Amendment has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

3. REFERENCE TO AND EFFECT ON THE COMMERCIALISATION AND SUPPLY AGREEMENT

This Amendment effects an amendment to the Agreement, in accordance with the terms of Clause 31 of the Commercialisation and Supply Agreement. Upon the date of this Amendment each reference in the Commercialisation and Supply Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Commercialisation and Supply Agreement as supplemented hereby. Other than as supplemented by this Amendment the Commercialisation and Supply Agreement shall be otherwise unchanged.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

4. INTERPRETATION

The interpretation and construction of this Amendment shall be made in accordance

with the terms of the Commercialisation and Supply Agreement and Clauses 25, 26, 30 and 35 of the Commercialisation and Supply Agreement are hereby incorporated by reference. In this Amendment capitalised words and phrases shall have the same meaning as in the Commercialisation and Supply Agreement except as otherwise set out herein.

5. EXECUTION IN COUNTERPARTS

This Amendment may be executed in any number of counterparts, each of which shall be considered an original instrument, but all of which together shall be considered one and the same agreement, and shall become binding when one or more counterparts have been signed by and delivered to each of the Parties.

In Witness Whereof, the Parties have executed this Amendment on the date first written above.

GW PHARMA LTD		ALMIRALL, S.A.

By:	/s/ Justin Gover	By:	/s/ Luciano Conde /s/ Joan Figueras
Name:	Justin Gover	Name:	L. Conde
Title:	Managing Director	Title:	C.O.O.


By:	/s/ David Kirk
Name:	David Kirk
Title:	Finance Director

Exhibit 10.14

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated November 17th , 2011

GW PHARMA LTD

and

ALMIRALL, S.A.

SUPPLEMENTARY AGREEMENT TO THE PRODUCT

COMMERCIALISATION AND SUPPLY CONSOLIDATED

AGREEMENT DATED

6 TH JUNE, 2006

THIS SUPPLEMENTARY AGREEMENT is made the 17th day of November of 2011 (“ Supplementary Agreement ”)

BETWEEN:

(2) ALMIRALL, S.A. a company incorporated in Spain whose principal place of business is General Mitre 151, 08022 Barcelona, Spain (“Almirall”).

WHEREAS:

(B) Pursuant to Clause 4.1.6 of the Commercialization and Supply Agreement, GW Pharma is responsible for the preparation, submission, prosecution and maintenance of all MAAs and other Regulatory Authority filings and applications required to obtain all necessary Marketing Authorisations to Commercialise Product in each country in the Territory and GW Pharma or its Affiliates shall be the owner and party of record for all such filings, applications and approvals.

(C) The Legal Requirements in Switzerland state that Marketing Authorisation for Product can only be granted to a person or company having its domicile, registered office or branch office in Switzerland and that the applicant must also have a manufacturing, import or wholesale licence. Neither GW Pharma nor any of its Affiliates is domiciled in Switzerland and GW Pharma does not have a registered office or branch office in Switzerland. It is therefore not possible for GW Pharma to submit any MAA to the Regulatory Authorities in Switzerland and/or be the party of record for any Marketing Authorisation.

(D) Almirall has an Affiliate in Switzerland called Almirall AG (hereinafter, referred to as “Almirall AG”), whose place of business is at Alte Winterthurerstrasse 14, CH-8304 Wallisellen, Switzerland. This Affiliate also holds import and wholesale licences.

(E) Pursuant to Clauses 9.4.1 and 10.13 of the Commercialization and Supply Agreement, respectively, *** and delivered to Almirall at ***. However, as agreed by the parties, the manufacturing plant identified in all MAAs filed in the Territory is GW Pharma’s plant located in *** and the Product will be delivered at GW Pharma’s premises in ***.

(F) The Parties have agreed that GW Pharma will appoint Almirall AG as its agent to file MAAs for Product in Switzerland and to be the party of record for any Marketing Authorisation granted pursuant thereto and to substitute the manufacturer of finished Product and the place where delivery of Product is to be effected.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

IT IS NOW AGREED AS FOLLOWS:

1. PREPARATION OF MAA AND ADDITIONAL REGULATORY DOCUMENTATION

1.1 GW Pharma shall be responsible for preparing, at its sole cost and expense, the MAA documentation and filings, as well as any additional regulatory documentation and notifications in connection with the MAA of the Product in Switzerland, as follows:

(a) GW Pharma shall prepare an MAA for Switzerland as soon as reasonably practicable after the date hereof and provide the same to Almirall for submission by Almirall AG to the Regulatory Authorities in Switzerland;

(b) once the foregoing MAA has been submitted to the Regulatory Authorities in Switzerland, GW Pharma shall prepare all additional documentation and notifications and undertake such other matters as may be required by Legal Requirements in Switzerland or may otherwise be reasonably desirable in order to procure the grant of a Marketing Authorisation in Switzerland;

(c) once a Marketing Authorisation has been granted in Switzerland, GW Pharma shall prepare all additional documentation and notifications and undertake such other matters as may be required by Legal Requirements in Switzerland or may otherwise be reasonably desirable in order to maintain such Marketing Authorisation in Switzerland;

(d) pursuant to the terms of the Pharmacovigilance Agreement, GW Pharma will provide individual case safety reports and periodic safety update reports to Almirall for Almirall to file with the Regulatory Authorities in Switzerland and the Pharmacovigilance Agreements shall remain unchanged.

2. SUBMISSION OF MAAs AND ADDITIONAL REGULATORY DOCUMENTATION

2.1 Almirall shall be responsible for the submission of all necessary Regulatory Authority filings and applications supplied by GW Pharma as required to obtain Marketing Authorisation in Switzerland, as well as being responsible for arranging all calls and meetings with Regulatory Authorities in Switzerland and, subject to Clause 2.4, the payment of all associated filing and maintenance fees, as follows:

(a) Almirall shall cause it Affiliate Almirall AG to file the MAA and other documents, notifications and undertakings supplied to it by GW Pharma with the Regulatory Authorities in Switzerland and register in the name of Almirall AG any Marketing Authorisation in Switzerland as directed by GW Pharma after receiving the MAA application and documentation from GW Pharma.

(b) Almirall shall provide GW Pharma with a copy of: (i) each document submitted to any Regulatory Authority in Switzerland in connection with obtaining or maintaining any Marketing Authorisation for the Product as soon as reasonably practically following the submission of such key documents to a Regulatory Authority, and (ii) within five (5) Business Day of receipt, all written or verbal communication or question relating to Product received by

Almirall AG from a Regulatory Authority in Switzerland. Each such document shall be sent to GW Pharma at the address and fax number specified in Clause 27.2 of the Commercialization and Supply Agreement, marked for the attention of GW Pharma’s Regulatory Affairs department.

(c) Almirall shall be responsible for arranging all meetings and calls with the Regulatory Authority in Switzerland relating to the MAA and the Marketing Authorisation as follows:

(i) Almirall will check the dates with GW Pharma and Almirall functions to ascertain when all necessary participants from GW Pharma and Almirall are available. Almirall will then cause Almirall AG to contact the relevant Regulatory Authority to propose meeting dates, which dates will be those agreed upon with GW Pharma.

(ii) Almirall and GW Pharma will put together the list of participants based on their expertise and scope of the meeting or conference call.

(iii) The participants will have a rehearsal to ensure agreement within Almirall/GW Pharma as to the responses to possible questions from the Regulatory Authority. This rehearsal will be initiated by GW Pharma as appropriate prior to the meeting/conference call with the Regulatory Authority.

(iv) Almirall will moderate all meetings/conference calls with Regulatory Authorities in Switzerland but will do so as GW Pharma directs.

For clarity, GW Pharma shall have the right to attend all calls and meetings with Regulatory Authority in Switzerland which relate to the MAA or any Marketing Authorisation. Almirall (or Almirall AG) shall also have the right to attend such meetings and calls and may respond to questions from the relevant Regulatory Authority’s representatives on such calls and at such meetings as directed by GW Pharma and as agreed in advance of such meeting or call.

2.2 Each of GW Pharma and Almirall shall perform its activities under Clauses 1 and 2.1 in a timely and professional manner in accordance with (i) Good Industry Practice and (ii) all applicable Legal Requirements, including the rules and regulations of the applicable Regulatory Authorities in Switzerland. Almirall shall at all times act in accordance with the reasonable instruction of GW Pharma in relation to all matters arising in connection with the MAAs and Marketing Authorisations in Switzerland and shall not undertake any act or do any thing contrary to the instruction of GW Pharma which would (or is reasonably likely to) prejudice any such MAA or Marketing Authorisation or any right, title or interest of GW Pharma therein save as expressly approved by GW Pharma in writing or as otherwise required by Law. Without prejudice to the foregoing, Almirall further agrees that it will not alter any MA Document provided by GW Pharma in any way, except with the express written consent of GW Pharma.

2.3 Other than to its Affiliate Almirall AG, Almirall will not sub-contract any of its obligations under this Supplementary Agreement without the prior written consent of GW Pharma, which consent may be given or withheld by GW Pharma in its sole discretion.

2.4 GW Pharma will reimburse Almirall in a timely manner all filing and maintenance fees incurred by Almirall or Almirall AG in performing their obligations under Clauses 2.1 and 2.2 of this Supplementary Agreement.

3. OWNERSHIP OF MAAs AND MARKETING AUTHORISATIONS

3.1 As between the Parties (and their respective Affiliates), the Parties agree that the MAAs and Marketing Authorisations in Switzerland shall at all times be the property of GW Pharma and, subject to Legal Requirements in Switzerland from time to time, GW Pharma shall have the right to be registered as the applicant in each MAA within Switzerland and as the sole holder of each Marketing Authorisation within Switzerland. Any MAA submitted in the name of Almirall AG or a Marketing Authorisation registered in the name of Almirall AG shall, on demand by GW Pharma, be transferred to and registered in the name of GW Pharma (or its Affiliates) and Almirall shall execute (and procure Almirall AG executes) all documents and undertake such further acts as may be necessary or desirable to give effect to the foregoing transfer to the extent permitted by the Legal Requirements in Switzerland.

3.2 GW Pharma hereby agrees to indemnify, defend and hold Almirall and its Affiliates (including their respective directors, officers and employees) harmless from and against any and all actions, suits, claims, demands, prosecutions, liabilities (including any penalties and fines imposed by any Competent Authorities), costs and expenses (other than those expressly allocated to Almirall or its Affiliates in this Supplementary Agreement), arising out or deriving from their condition of applicant of the MAA and holder of the Marketing Authorisation in Switzerland or the performance of any of their obligations under this Supplementary Agreement except where such actions, suits, claims, demands, prosecutions, liabilities (including any penalties and fines imposed by any Competent Authorities), costs and expenses arise from a breach by Almirall or its Affiliates of Clause 1, 2.1, and/or 2.3 hereof or from the unauthorised alteration by Almirall of any MA Document provided by GW Pharma. Almirall shall indemnify GW Pharma, its Affiliates (including their respective directors, officers and employees) haimless from and against any and all actions, suits, claims, demands, prosecutions, liabilities (including any penalties and fines imposed by any Competent Authorities), costs and expenses arising from a breach by Almirall or its Affiliates of Clause 1, 2.1, 2.2 and/or 2.3 hereof, as if it were a GW Pharma Third Party Claim, but only to the extent that such a breach is attributable to the gross negligence or willful misconduct of Almirall or its Affiliates.

Furthermore, it is expressly agreed that a failure by Almirall or its Affiliates to perform or comply with any of its responsibilities pursuant to this Supplementary Agreement, in connection with the MAA or Marketing Authorisation in Switzerland, shall in no event be regarded as a material breach of the Commercialization and Supply Agreement for any purposes, especially for purposes of termination of the Commercialization and Supply Agreement pursuant to its Clause 20.2, which Clause shall not be applicable to a breach or default of any commitments of Almirall or its Affiliates under this Supplementary Agreement.

3.3 Almirall hereby assigns to GW Pharma all right, title and interest (including the assignment of all future right, title and interest) as Almirall (or Almirall AG) may have or may subsequently acquire in any and all MA Documents and shall on demand by GW Pharma execute (and procure Almirall AG executes) all such documents and undertake such further acts as may be necessary or desirable to give effect to the foregoing assignment or otherwise record or evidence such assignment and (where applicable) physically deliver the same to GW Pharma.

3.4 Upon termination of the Commercialization and Supply Agreement, and without prejudice to the application of Clause 21.2.3 of the Commercialisation and Supply Agreement, Almirall hereby undertakes to cause Almirall AG to return all MA Documents and any other documents provided by GW Pharma and any copies of MA Documents, without withholding copies thereof except that Almirall may retain one (1) copy of any MA Document to the extent required by, and solely for the purpose of, discharging its obligations under any Legal Requirement in Switzerland.

4. NEW MANUFACTURING PLANT

4.1 The Parties agree that the Product is to be manufactured and delivered to Almirall at the Manufacturing Plant, which substitutes, for these purposes, the plant of ***.

4.2 Accordingly, Clause 9.4.1 of the Commercialization and Supply Agreement shall be deemed replaced by the following:

“9.4.1 Almirall acknowledges and agrees that GW Pharma already has a second source for each stage of its manufacturing process save steps to produce finished Product from Botanical Drug Substance. The Parties understand that GW Pharma will produce finished Product from Botanical Drug Substance in its manufacturing facility located at *** United Kingdom (the “Manufacturing Plant”). The Parties also agree that it is necessary for GW Pharma to have in place a second site for manufacture of finished Product from Botanical Drug Substance (the “Second Site”). Within thirty (30) days of Almirall completing its audit of the Manufacturing Plant, Almirall shall inform GW Pharma of whether it is prepared to establish at its own manufacturing facility the Second Site. If Almirall is so willing it shall, subject to obtaining the necessary licences and consents, establish at its own manufacturing facility the Second Site and validate such site by Launch. In such circumstances this Second Site shall only become operational in the event that GW Pharma is unable to fulfill its supply obligations from the Manufacturing Plant. At the time of first use the Parties will negotiate an agreement pursuant to which Almirall would manufacture finished Product for GW Pharma. This agreement will include the obligation for Almirall to manufacture Product to fill orders for Product both inside and outside the Territory. For clarity, where Almirall is manufacturing finished Products pursuant to this Clause 9.4 priority shall be given to the manufacture of Product for the Territory, thereafter Almirall shall, subject to capacity at its manufacturing facility, manufacture Product to meet the requirement of GW Pharma’s ex-EU Partners in the British Isles and Canada for so long as it takes GW Pharma to validate a second site to manufacturing finished Product for these countries. If Almirall is not willing establish the Second Site at its manufacturing facilities GW Pharma shall, in its discretion, be free to identify a Third Party to provide the Second Site.”

4.3 Furthermore, Clause 10.13 of the Commercialization and Supply Agreement shall be deemed replaced by the following:

“10.13 All Product supplied under this Agreement shall be delivered FCA

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(Incoterms 2010) GW Pharma’s premises located in *** and shall be accompanied by a written Certificate of Analysis and Release confirming that such quantity of Product meets the Specification, a Packing-list and an insurance policy. GW Pharma shall secure transport and insurance, from the said GW Pharma’s premises in *** to Sant Andreu de la Barca (Barcelona) or its nominee’s facility in Europe, with its own providers at Almirall’s cost and expense. Almirall shall pay all freight, insurance charges, taxes, import and export duties, inspection fees and other charges applicable to the sale and transport of Product purchased by Almirall hereunder which amounts shall be separately set forth on GW Pharma’s invoices to Almirall. Title and risk of loss and damage to Product purchased by Almirall hereunder shall pass to Almirall upon collection of the Product by the Third Party carrier.”

5. REFERENCE TO AND EFFECT ON THE COMMERCIALISATION AND SUPPLY AGREEMENT

This Supplementary Agreement effects an amendment to the Commercialization and Supply Agreement, in accordance with the terms of Clause 31 of the Commercialisation and Supply Agreement. Each reference in the Commercialisation and Supply Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Commercialisation and Supply Agreement as supplemented hereby. Other than as supplemented by this Supplementary Agreement the Commercialisation and Supply Agreement, as amended and supplemented, shall be otherwise unchanged.

6. INTERPRETATION

The interpretation and construction of this Supplementary Agreement shall be made in accordance with the terms of the Commercialisation and Supply Agreement and Clauses 25, 26, 30 and 35 of the Commercialisation and Supply Agreement are hereby incorporated by reference. In this Supplementary Agreement all capitalised words and phrases shall have the same meaning as in the Commercialisation and Supply Agreement except as otherwise set out herein.

Additionally, for the purposes of this Supplementary Agreement, “ MA Documents ” shall mean all correspondence, documentation and other information (howsoever stored or recorded, including without limitation e-mail correspondence, paper records and computer files) as may concern any MAA or Marketing Authorisation submitted to, filed with or issued by the Regulatory Authorities in Switzerland including without limitation (i) all CMC Data and other GW Pharma Know How submitted or prepared in respect of any MAA or Marketing Authorisation hereunder and (ii) all MAAs and Marketing Authorisations submitted, filed or issued hereunder.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

7. EXECUTION IN COUNTERPARTS

This Supplementary Agreement may be executed in any number of counterparts, each of which shall be considered an original instrument, but all of which together shall be considered one and the same agreement, and shall become binding when one or more counterparts have been signed by and delivered to each of the Parties.

In Witness Whereof, the Parties have executed this Supplementary Agreement on the date first written above.

GW PHARMA Ltd.		ALMIRALL, S.A.

/s/ Justin Gover		/s/ illegible

Exhibit 10.15

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated 13 TH March 2012

GW PHARMA LTD

and

ALMIRALL, S.A.

AMENDMENT AND SUPPLEMENTARY AGREEMENT TO

THE PRODUCT COMMERCIALISATION AND SUPPLY

CONSOLIDATED AGREEMENT DATED

6 JUNE, 2006

A LIMITED LIABILITY PARTNERSHIP

CityPoint, One Ropemaker Street | London EC2Y 9AW

Tel: +44 20 7920 4000 | Fax: +44 20 7496 8500

www.mofo.com

THIS AMENDMENT AGREEMENT is made the 13th of March 2012 (“Amendment”)

BETWEEN:

(1) GW PHARMA LTD, a company organized under the laws of England, whose principal place of business is Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom (“ GW Pharma ”); and

(2) ALMIRALL, S.A. a company incorporated in Spain whose principal place of business is General Mitre 151, 08022 Barcelona, Spain (“ Almirall ”).

WHEREAS:

(B) The Parties now wish to further amend and supplement the terms of the Commercialisation and Supply Agreement as set out herein.

IT IS NOW AGREED AS FOLLOWS:

1. AMENDMENTS

The Parties agree that the provisions of the Commercialisation and Supply Agreement are amended as follows:

1.1 The definition of “Supply Price” in Clause 1.1 is deleted and replaced by the following:

“Supply Price” — the price per Unit (calculated on a country by country basis) at which GW Pharma will supply Almirall with Product being:

(i) If, and for so long as, Product is not Launched for the Principal Indication of relief of pain associated with cancer:

(1) for each Calendar Year during the period from *** until ***, (A) *** of the Net Selling Price on Net Sales of up to *** and (B) ***of the Net Selling Price on Net Sales of *** or more;

(2) for each Calendar Year during the period from *** until ***, (A) *** of the Net Selling Price on Net Sales of up to *** and (B) *** of the Net Selling Price on Net Sales of *** or more; and

(3) for each Calendar Year during the period from ***, *** of the Net Selling Price, or

(ii) if Product is Launched for the Principal Indication of relief of pain associated with cancer:

(1) for each Calendar Year during the period from 1 January 2012 until the date of Launch of Product in the first Major European Market for the Principal Indication of relief of pain associated with cancer, after approval of such Principal Indication in such Major European Market (“ CP Launch Date ”), the Supply Price set out in (i) above shall apply;

(2) if the CP Launch Date occurs prior to or on ***:

a. for each Calendar Year (or portion thereof) during the period from the CP Launch Date until ***, (A) *** of the Net Selling Price on Net Sales of up to *** and (B) *** of the Net Selling Price on Net Sales of *** or more; and

b. for each Calendar Year during the period from ***, *** of the Net Selling Price,

(3) if the CP Launch Date occurs after ***:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

a. for each Calendar Year (or portion thereof) during the period from the CP Launch Date until the date falling *** months after the CP Launch Date, (A) *** of the Net Selling Price on Net Sales of up to *** and (B) *** of the Net Selling Price on Net Sales of *** or more; and

b. for each Calendar Year (or portion thereof) during the period from the date falling *** months after the CP Launch Date, *** of the Net Selling Price.

1.2 Mexico is included in the Territory and the corresponding definition of Territory in Clause 1.1 is deleted and replaced by the following:

“Territory” — Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Macedonia, Mexico, Monaco, Norway, Poland, Portugal, Romania, San Marino, Serbia and Montenegro, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, Turkey and the Vatican City. For clarity the Territory does not include Great Britain, Northern Ireland, the Channel Islands or the Isle of Man.

1.3 Clause 11.2 of the Commercialisation and Supply Agreement is deleted and replaced by the following:

“11.2 Upon shipment of Product to Almirall, GW Pharma shall submit invoices to Almirall, on a country by country basis, as follows:

11.2.1 during the period from *** until *** GW Pharma shall invoice Almirall for Product at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Calendar Year (or List Price, if no sales of Product have been made in such country during the previous Calendar Year).

11.2.2 hereafter, subject to Clause 11.2.3, for so long as the Product is not Launched in the first Major European Market for the Principal Indication of relief of pain associated with cancer after approval of such Principal Indication in such Major European Market, GW Pharma shall invoice Almirall for Product: (a) for the period from *** until ***, at a price per Unit of *** of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable); (b) for the period from *** until ***, at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable); and (c) for the period from ***, at a price per Unit of *** (***%) the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable).

11.2.3 if, after ***, Product is Launched in the first Major European Market for the Principal Indication of relief of pain associated with cancer after approval of such Principal Indication in such Major European Market, GW Pharma shall invoice Almirall for Product for the period from the CP Launch Date at a price per Unit of *** per cent (***%) of the Net Selling Price (for that country) as calculated for the previous Calendar Year (or List Price, when applicable).

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.4 Clause 11.5.6 of the Commercialisation and Supply Agreement is deleted and replaced by the following:

“11.5.6 the total of the calculation being the balancing payment due. GW will then raise an invoice or credit note accordingly and the Party which this calculation shows needs to make a balancing payment shall pay the amount due to the other within thirty (30) days of receipt of the relevant invoice or credit note. Any dispute between the Parties as to the basis of the calculation shall be resolved in accordance with the mechanism set out in Clauses 11.14 and 11.15. The above calculation is designed to adjust (i) the Supply Price payable for the Product in each country and (ii) the price of the Product held in stock by Almirall at the Calendar Year end to the new Invoice Price for that country for the new Calendar Year such that goods in transit or timing differences should be taken into account in the above calculation to make the numbers used equitable between the Parties.”

1.5 Clause 11.7.5 of the Commercialisation and Supply Agreement is deleted and replaced by the following:

“11.7.5 *** upon the recruitment of a total of *** patients for participation in GW Pharma’s Phase III Clinical Trial GWCA0958 for the relief of pain associated with cancer. Notwithstanding anything to the contrary in the first sentence of Clause 11.13, Almirall shall make the milestone payment set out in this Clause 11.7.5 in Euros.”

1.6 The regulatory approval milestone payments established for the second Indication in Clauses 11.8.5 to 11.8.8 (inclusive) of the Commercialisation and Supply Agreement are deleted-and Clauses 11.8.1 to 11.8.12 of the Commercialisation and Supply Agreement are deleted and replaced by the following:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“ ***

11.8.1 ***;

11.8.2 ***;

11.8.3 ***.

***

Second Indication to be granted a Marketing Authorisation

11.8.4 ***;

11.8.5 ***;

11.8.6 ***;

11.8.7 ***.

For the purposes of Clause 11.8 the two (2) Indications are:

(i) pain or spasticity in multiple sclerosis; and

(ii) neuropathic pain associated with any disease other than multiple sclerosis.”

1.7 For clarity, the Parties acknowledge and agree that, as at the Amendment Effective Date,

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

the milestone payments set out in Clause 11.8.1 and Clause 11.8.2 of the Commercialization and Supply Agreement have been paid by Almirall to GW Pharma.

2. SUPPLEMENTARY AGREEMENT IN RESPECT OF MEXICO

2.1 In consideration of the grant of rights in respect of Mexico, Almirall shall pay to GW Pharma a technical access fee equal to ***. Such technical access fee shall be payable by Almirall within thirty (30) days of the later of (i) the date of this Amendment or (ii) receipt of an invoice therefor from GW Pharma.

2.2 The Parties have agreed that, notwithstanding anything to the contrary in the Commercialisation and Supply Agreement (and in particular in Clause 4.1.6 of the Commercialisation and Supply Agreement), Almirall shall be responsible for all reasonable costs and expenses paid by GW Pharma to Third Parties with respect to the preparation, submission, prosecution and maintenance of all CTAs, MAAs and other filings, applications, permissions and other approvals required by any Regulatory Authority to the extent specifically required to obtain necessary Marketing Authorisations to Commercialise Product in Mexico.

2.3 Nothing in this Amendment or in the Commercialisation and Supply Agreement shall be construed to oblige Almirall to carry out or fund any studies or development activities (including without limitation Clinical Trials) which may be at any time required for the preparation, submission, obtaining and/or maintenance of any necessary Marketing Authorisations to Commercialise Product in Mexico. In case

any substantial costs or expenses are required to be incurred or paid by Almirall in connection with any MAAs or Marketing Authorisations in Mexico, Almirall shall have the right to decide at its sole discretion not to incur any such expenses and, where applicable, to cancel and withdraw the relevant authorisations so affected, as well as to exclude Mexico from the Territory covered in the Commercialisation and Supply Agreement, by written notice to GW Pharma to become immediately effective.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

2.4 If required by Applicable Laws, Almirall shall cause its Mexican Affiliate to act as GW Pharma’s agent to file MAAs for Product in Mexico in the name of such Almirall’s Mexican Affiliate. In such circumstances and to permit Almirall to act as GW Pharma’s agent for the purposes of filing MAAs for Product in Mexico, the Parties shall supplement the terms of the Commercialization and Supply Agreement on terms substantially similar to the Supplementary Agreement in respect of Switzerland dated November 17, 2011.

3. EFFECT

This Amendment shall become effective on the date first written above (the “ Amendment Effective Date ”).

4. REPRESENTATIONS AND WARRANTIES

4.1 As of the Amendment Effective Date each Party hereby represents and warrants to the other Party that it (i) has the power and authority and the legal right to enter into this Amendment and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Amendment and the performance of its obligations hereunder. This Amendment has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

5. REFERENCE TO AND EFFECT ON THE COMMERCIALISATION AND SUPPLY AGREEMENT

This Amendment effects an amendment to the Agreement, in accordance with the terms of Clause 31 of the Commercialisation and Supply Agreement. Upon the

Amendment Effective Date each reference in the Commercialisation and Supply Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Commercialisation and Supply Agreement as supplemented hereby. Other than as supplemented by this Amendment the Commercialisation and Supply Agreement shall be otherwise unchanged.

6. INTERPRETATION

The interpretation and construction of this Amendment shall be made in accordance with the terms of the Commercialisation and Supply Agreement and Clauses 25, 26, 30 and 35 of the Commercialisation and Supply Agreement are hereby incorporated by reference. In this Amendment capitalised words and phrases shall have the same meaning as in the Commercialisation and Supply Agreement except as otherwise set out herein.

7. EXECUTION IN COUNTERPARTS

In Witness Whereof, the Parties have executed this Amendment on the date first written above.

GW PHARMA LTD		ALMIRALL, S.A.


By:	/s/ Justin Gover	By:	/s/ illegible

Exhibit 10.16

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

RESEARCH COLLABORATION AND LICENCE AGREEMENT

between

GW PHARMA LTD

and

GW PHARMACEUTICALS PLC

and

OTSUKA PHARMACEUTICAL CO., LTD

dated as of July 9, 2007

Execution Copy

TABLE OF CONTENTS

			Page

1.	DEFINITIONS		2

2.	GOVERNANCE		23

3.	ESTABLISHMENT AND CONDUCT OF THE RESEARCH COLLABORATION		30

4.	MANUFACTURE AND SUPPLY OF RESEARCH COMPOUNDS		38

5.	REGULATORY MATTERS		38

6.	CLINICAL DEVELOPMENT OF PRODUCT CANDIDATES AND LICENCE AGREEMENTS		40

7.	RESTRICTIONS AND OTHER RIGHTS		44

8.	FUNDING OF THE RESEARCH COLLABORATION		46

9.	ROYALTY BEARING PRODUCTS		49

10.	PAYMENTS; RECORDS; AUDITS		51

11.	CONFIDENTIALITY		53

12.	INTELLECTUAL PROPERTY RIGHTS		57

13.	REPRESENTATIONS, WARRANTIES AND ADDITIONAL COVENANTS		63

14.	TERM; TERMINATION		65

15.	DISPUTE RESOLUTION		72

16.	MISCELLANEOUS		75

17.	GUARANTEE BY GW PHARMACEUTICALS PLC		78

SCHEDULES

SCHEDULE 1.1.79		RESEARCH PLAN FOR FIRST RESEARCH YEAR

SCHEDULE 11.3		AGREED FORM PRESS RELEASE

SCHEDULE 14.1		FORM OF AMENDED AND RESTATED RESEARCH COLLABORATION AND LICENCE AGREEMENT

RESEARCH COLLABORATION AND LICENCE AGREEMENT

THIS RESEARCH COLLABORATION AND LICENCE AGREEMENT is entered into as of July 9, 2007

BETWEEN:

(1) GW PHARMA LTD , a company organized under the laws of England, having offices at Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom, on behalf of itself and its Affiliates (“ GW Pharma ”);

(2) GW PHARMACEUTICALS PLC , a company organized under the laws of England, having offices at Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom; and

(3) OTSUKA PHARMACEUTICAL CO., LTD. , a Japan corporation, with its registered office at 2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (“ Otsuka ”).

WHEREAS:

(A) GW Pharma possesses significant expertise in the research and development of pharmaceutical preparations based upon botanical extracts from chemovars of Cannabis sativa .

(B) GW Pharma and Otsuka entered into a licence agreement on February 14th, 2007, under which GW Pharma licensed Otsuka to develop and commercialize GW Pharma’s lead product SATIVEX TM oromucosal spray for the US market.

(C) GW Pharma has proprietary knowledge and interests in the research and development of pharmaceutical preparations based upon botanical extracts from different chemovars of Cannabis sativa in addition to that combination of botanical extracts used in SATIVEX TM oromucosal spray.

(D) Otsuka has an interest in the research and development of pharmaceutical preparations based upon botanical extracts from chemovars of Cannabis sativa for the treatment of CNS and cancer indications and Otsuka wishes to collaborate with GW Pharma in the research and early stage development of pharmaceutical preparations

based upon Research Compounds (as defined below) for the treatment of CNS and cancer indications on the terms set out below.

(E) Thereafter, Otsuka may wish to further develop and commercialize Products containing Product Candidates in the Territory (each as hereafter defined) and GW Pharma is willing to negotiate with Otsuka licences to do so upon the terms set out below.

(F) GW Pharmaceuticals plc guarantees the financial obligations of GW Pharma and is a party to this Agreement solely for the purpose of the guarantee set out in Section 17.

NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto intending to be legally bound hereby AGREE AS FOLLOWS:

1. DEFINITIONS

1.1 In this Agreement the following definitions shall apply unless the context requires otherwise:

1.1.1 “ Actual Costs ” shall have the meaning set out in Section 8.2.

1.1.2 “ Affiliate ” shall mean any corporation or other entity that controls, is controlled by, or is under common control with, a Party. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns, or directly or indirectly controls, more than 50% of the voting securities or other ownership interest of the other corporation or entity or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity. For purposes of this Agreement, Taiho Pharmaceutical Co., Ltd shall not be deemed to be an Affiliate of Otsuka.

1.1.3 “ Agreement ” shall mean this document including any and all schedules, appendices and other addenda to it as may be added and/or amended from time to time in accordance with the provisions of this document.

1.1.4 “ Allocable Research Overhead ” shall mean an amount added to an item of cost to reflect a directly related overhead incurred by a Party or for its account in relation to such item of cost, including occupancy costs, heating, lighting and power costs, information system costs, payroll processing costs (in each case based on space occupied or headcount or other activity-based method consistently applied) and fairly allocated costs of calibrating and maintaining equipment, but excluding such things as general and administrative and legal expenses (other than research administration expenses) and costs that do not involve a cash outlay.

1.1.5 “ BDC Data Package ” shall mean a package of Documents setting out all the Know How within GW Pharma Background IP Controlled by GW Pharma which relates to a particular BDC.

1.1.6 “ Botanical Drug Candidate ” or “ BDC ” shall mean:-

(a) any cannabinoid from a single chemovar of a chemically and genetically characterized Cannabis sativa plant (“ Phytocannabinoid ”) at any stage of research or development made using any extraction method and in any degree of purification in which only a single cannabinoid is present in a concentration which has the potential to be therapeutically active including, without limitation, the *** fraction and the *** fraction separately; and

(b) a combination of two or more Phytocannabinoid extracts described in (a) above containing two or more Phytocannabinoids present in concentrations such that both have the potential to be therapeutically active mixed in a precise ratio i.e. the *** and *** fractions mixed (without other fractions) in the ratio of *** of ***. For clarity specifically excluded from the definition of BDC is any combination of the *** and *** fractions when mixed (without other fractions) in a ratio of *** to *** that falls inside the range of *** to ***; and

(c) any biological or chemical modifications of the Phytocannabinoids in (a) or (b) including any metabolite or degradant.

1.1.7 “ Business Day ” shall mean any calendar day during which commercial banks are open for business in London, England, New York, New York, and Tokyo, Japan.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.1.8 “ CBD ” shall mean Cannabidiol.

1.1.9 “ cGMPs ” shall mean the then current and applicable good manufacturing practice regulations established in 21 C.F.R. Parts 210 and 211, as amended and in effect from time to time, and other applicable FDA policies and the Guide to GMP for Medicinal Products as promulgated under applicable European Directives and in effect from time to time during the term of this Agreement.

1.1.10 “ Change of Control ” shall mean the occurrence of a tender offer, stock purchase, other stock acquisition, merger, consolidation, recapitalization, reverse split, sale or transfer of assets or other transaction, as a result of which any Person other than an Affiliate of a Party gains Control of that Party. “Control” for purposes of this Section 1.1.10 refers to any of the following (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through ownership of voting securities, by contract or otherwise; (ii) ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or of fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; (iii) any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity.

1.1.11 “ Clinical Development ” shall mean all clinical and non-clinical development and regulatory activities regarding a Product Candidate in a country of the Territory to be conducted by or upon behalf of Otsuka and its Affiliates with the aim of obtaining Regulatory Approval in that country with the exception of the clinical and non-clinical activity conducted in relation to such Product Candidate or Selected Drug Candidate pursuant to the Research Collaboration.

1.1.12 “ Collaboration IP ” shall mean (i) Collaboration Materials; (ii) Know How conceived developed or generated in the course of the activities performed by or on behalf of either Party or both Parties under the Research Collaboration; and (iii) any Patent Rights which claim either Collaboration Materials or inventions included within the Know How the subject of (ii) above, which

Patent Rights have a priority date after the Effective Date and were conceived during the Research Term or the Extended Research Term (as applicable) and reduced to practice during the Research Term or the Extended Research Term or thereafter as a result of the performance of the Research Collaboration (“ Joint Patent Rights ”). “Conception” for purposes of the foregoing definition and the definition set forth below in Section 1.1.13 shall be determined by reference to the Parties’ written records including laboratory notebooks.

1.1.13 “ Collaboration Materials ” shall mean Research Compounds or other Materials first generated or synthesized by or on behalf of either or both of the Parties during the Research Term, the Extended Research Term (as applicable) as a result of the performance of the Research Collaboration.

1.1.14 “ Combination Product ” shall mean a product that contains, in addition to a Royalty Bearing Product, one or more other therapeutically active ingredients or a Third Party proprietary delivery system where the Third Party is due a payment upon the sale of such product.

1.1.15 “ Competitive Product ” shall mean any cannabinoid-containing pharmaceutical product in which (i) in any multi-cannabinoid-containing pharmaceutical product the cannabinoid found in the highest concentration relative to all other cannabinoids in such pharmaceutical product (the “Major Cannabinoid”) is found in any multi-cannabinoid-containing Selected Drug Candidate, Product Candidate or Product in a concentration relative to the other cannabinoids in such Selected Drug Candidate, Product Candidate or Product within a range of *** percentage points more to *** percentage points less of the relative concentration of such Major Cannabinoid in such cannabinoid-containing pharmaceutical product as compared to all other cannabinoids contained therein, or (ii) the *** cannabinoid in a single cannabinoid-containing pharmaceutical product is found in a Selected Drug Candidate, Product Candidate or Product in a concentration of ***% or more. The phrase “*** percentage points more to *** percentage points less” shall mean by way of example, in a Selected Drug Candidate, a Product Candidate or a Product in which the Major Cannabinoid comprises *** of all cannabinoids in such pharmaceutical product (with all other cannabinoids comprising *** thereof), a range of *** to ***.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.1.16 “ Confidential Information ” shall mean: (i) the terms and conditions of this Agreement, for which each Party will be considered a Disclosing Party and a Recipient Party; (ii) Know How within GW Pharma Background Know How for which GW Pharma will be considered the Disclosing Party and Otsuka shall be the Recipient Party; (iii) Know How within Collaboration IP in relation to which both Parties will be considered a Disclosing Party and a Recipient Party, and (iv) any other proprietary or confidential information of a Party that is communicated in any way or form by one Party to the other Party, either prior to or after the Effective Date, and whether or not such information is identified as confidential at the time of disclosure. For clarity, and without limiting the generality of the foregoing, information not identified as confidential by the Disclosing Party at the time of disclosure shall be deemed to be Confidential Information if the Recipient Party knows, or should have had a reasonable expectation, that the information communicated by the Disclosing Party is Confidential Information of the Disclosing Party. Notwithstanding the foregoing, Confidential Information shall not include any information which the Recipient Party can prove by competent evidence:

(a) is now, or hereafter becomes, through no act or failure to act on the part of the Recipient Party, generally known or available;

(b) is known by the Recipient Party at the time of receiving such information, as evidenced by its records;

(c) is hereafter furnished to the Recipient Party by a Third Party, as a matter of right and without restriction on disclosure; or

(d) is independently developed by or on behalf of the Recipient Party, as evidenced by its records, by Persons without knowledge of, and without the aid, application or use of, the Confidential Information of the Disclosing Party.

Party’s possession. In addition, any combination of features shall not be deemed to be within the foregoing exceptions merely because individual features are in the public domain or in the Recipient Party’s possession.

1.1.17 “ Control ” (including variations such as “ Controlled ”) shall mean with respect to any Know How or Patent Rights, possession of the right, whether directly or indirectly, and whether by ownership, licence or otherwise, to assign, or grant a licence, sub-licence or other right to or under, such Know How or Patent Rights without violating the terms of any agreement or other arrangement with any Third Party.

1.1.18 “ Cost of Work ” shall mean Third Party Costs, but limited to those items charged by the University of Aberdeen in relation to the supervision, hosting and assistance services provided to the Otsuka Scientists by the University of Aberdeen while the Otsuka Scientists are performing at University of Aberdeen facilities the Initial Pharmacological Evaluation Study activities allocated to Otsuka under the Research Plans, and any related Allocable Research Overheads incurred by GW Pharma

1.1.19 “ Cover ” (including the variations such as “ Covered ”, “ Coverage ” or “ Covering ”) shall mean with respect to a Patent Right, that the making, using or other commercialization of a given product in a commercialized form would infringe a Valid Claim of such Patent Right in the country where such activity occurs in the absence of a licence under such Patent Right, and with respect to Know How, shall mean that the making, using or other commercialization of a given product in a commercialisable form would require use of such Know How.

1.1.20 “ Developmental CMC Data ” shall mean the data and other Know How relating to the chemistry, manufacturing and controls for a Selected Drug Candidate limited to that chemistry, manufacturing and controls data for a specific Selected Drug Candidate (including stability data) which is required (and only that chemistry, manufacturing and controls data which is required) in order to prepare applications for INDs and otherwise to progress the Pre-

Licence Development of such Selected Drug Candidate in accordance with the Research Plan.

1.1.21 “ Disclosing Party ” shall mean the Party which discloses Confidential Information to the other Party.

1.1.22 “ Documents ” shall mean analyses, books, CD-ROM, charts, comments, computations, designs, discs, diskettes, files, graphs, ledgers, notebooks, paper, photographs, plans, records, recordings, reports, research notes, tapes and any other graphic or written data or other media on which Know How is permanently stored.

1.1.23 “ Early Clinical Evaluation Studies ” shall mean one or more small-scale clinical studies approved by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom or equivalent authority in any other country using healthy volunteers or patients in Phase I Clinical Studies or Phase IIa Clinical Studies.

1.1.24 “ Effective Date ” shall mean the date of this Agreement first written above.

1.1.25 “ Equipment Costs ” shall mean: (i) where GW Pharma is required by the JRC to acquire a new piece of equipment for the purposes of performing its obligations hereunder which costs in excess of ***, the price paid by GW Pharma for that equipment; and (ii) for any equipment used by GW Pharma in performing its obligations hereunder other than that equipment the subject of (i) above, the fairly allocated costs of any such equipment required and actually used by GW Pharma to carry out its obligations under the Research Plan or any part thereof in a Research Year consistent with IAS, but only to the extent such costs have not been amortised previously by GW Pharma.

1.1.26 “ Extended Research Term ” shall have the meaning given to it in Section 1.1.78.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.1.27 “ FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.

1.1.28 “ FTE ” shall mean a full time equivalent person year equal to at least two hundred and twenty seven (227) working days per year of work carried out by an employee of GW Pharma.

1.1.29 “ FTE Costs ” shall mean the cost of FTEs at the FTE Rate.

1.1.30 “ FTE Rate ” shall mean the internal cost of a single FTE of GW Pharma per Research Year performing pursuant to a Research Plan. The FTE Rate for a GW Pharma employee fairly allocated to the Research Collaboration shall reflect to the extent relating to performance of a Research Plan (i) the fully burdened internal costs of such FTE including all employee-related compensation, including but not limited to, salaries, wages, bonuses, benefits, and any other employment costs, including subsistence costs, training, recruiting, relocation, professional dues and other costs together with (ii) related Allocable Research Overhead and (iii) the cost of general consumables used by such FTE, both (ii) and (iii) fairly allocated to such FTE.

1.1.31 “ GAAP ” shall mean generally accepted accounting principles of Japan, as amended from time to time and then in effect.

1.1.32 “ GCP ” shall mean the then current and applicable clinical practice regulations as set out in: (i) Directive 2001/20/EC and Directive 2001/83/EC as well as ICH-GCP and any other guidelines for good clinical practice for trials on medicinal products in the European Community as amended and applicable from time to time; and (ii) US Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Applications), as may be amended from time to time; and (iii) the Declaration of Helsinki as last amended at the 52nd World Medical Association in October 2000 and any further amendments thereto; and (iv) the equivalent Laws in any other jurisdiction in which Early Clinical Evaluation Studies are conducted.

1.1.33 “ GLP ” shall mean the then current and applicable laboratory practice regulations as set out in: (i) Directive 2004/9/EC and Directive 2004/10/EC, as may be amended or replaced from time to time as well as any “Rules Governing Medicinal Products in the European Community Vol III, ISBN 92.825 9619-2 (ex OECD principles of GLP) as amended and applicable from time to time ; and (ii) US Code of Federal Regulations, Title 21, Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies) as amended and applicable from time to time; and (iii) the equivalent Laws in any other jurisdiction in which Pre-Clinical Studies are conducted.

1.1.34 “ GW/Otsuka Cannabinoid Research Institute ” or “ GW/Otsuka CRI ” shall be the name under which the Research Collaboration may sponsor seminars, interface with academic institutions, receive scientific credit on publications by GW Pharma and Otsuka scientists publishing the results of the Research Collaboration, and engage in similar activities. For the avoidance of doubt, however, the Research Collaboration shall only be a contractual relationship between the Parties and the Parties shall not be entitled to conduct business under the name GW/Otsuka Cannabinoid Research Institute or GW/Otsuka CRI. No contract shall be entered into by either or both of the Parties, whether of a commercial nature, for employment or otherwise in the name of the GW/Otsuka Cannabinoid Research Institute or the GW/Otsuka CRI. GW Pharma shall make such fictitious name filing as may be permitted with appropriate authorities for purposes of putting the public on notice of the identities of the Parties in interest in the GW/Otsuka Cannabinoid Research Institute and the GW/Otsuka GRI and the lack of any entity being associated with such names.

1.1.35 “ GW Pharma ” shall have the meaning provided in the introductory paragraph to this Agreement.

1.1.36 “ GW Pharma Background IP ” shall mean Patent Rights and Know How Controlled by GW Pharma either at the Effective Date or during the Research Term and any Extended Research Term that either Covers or relates to Research Compounds, but in the case of Patent Rights Covering Research Compounds only insofar as they do so i.e., if there are claims of a Patent Right

that Cover a Research Compound and other claims that do not, it is only those claims that Cover a Research Compound that fall within this definition (“ GW Pharma Patent Rights ”) and always excluding Collaboration IP.

1.1.37 “ GW Pharma Patent Rights ” shall have the meaning given to it in Section 1.1.36.

1.1.38 “ GW Pharma Product ” has the meaning given to it in Section 7.2.

1.1.39 “ IAS ” shall mean international accounting standards, as promulgated by the International Accounting Standards Board, or a successor organization, from time to time and then in effect.

1.1.40 “ ICH-GCP ” shall mean the ICH Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95).

1.1.41 “ IND ” shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the USA, or any comparable application to and acceptance by the Regulatory Authority of a country or group of countries other than the USA thereto including but not limited to the EMEA prior to beginning clinical trials in humans in that country or in that group of countries.

1.1.42 “ Initial Pharmacological Evaluation Studies ” shall mean non-GLP in vitro and in vivo pharmacological studies of Selected BDCs conducted for the purpose of evaluating the efficacy and toxicity of such Selected BDCs.

1.1.43 “ Insolvency Officer ” shall mean a receiver, administrative receiver, administrator, liquidator, trustee, or a nominee or supervisor in respect of a company voluntary or involuntary arrangement or scheme of arrangement or any other similar official that it would be possible to appoint under applicable insolvency law to or over the assets of a company or other legal entity.

1.1.44 “ Insolvency Proceeding ” shall mean in respect of a company or other legal entity (i) the appointment of an Insolvency Officer or (ii) such company or legal entity becoming subject to a company voluntary arrangement, a scheme

of arrangement or other composition or arrangement with or for the benefit of all or substantially all of such entity’s creditors.

1.1.45 “ Joint Patent Rights ” shall have the meaning given to it in Section 1.1.12.

1.1.46 “ Joint Research Committee ” or “ JRC ” shall mean the committee to be established pursuant to Section 2.1.

1.1.47 “ JRC Chairperson ” has the meaning given to it in Section 2.1.1.

1.1.48 “ JRC Members ” has the meaning given to it in Section 2.1.1.

1.1.49 “ Know How ” shall mean any and all proprietary confidential technical and scientific information which is not in the public domain, including botanical Materials and other tangible Materials, discoveries, unpatented inventions, improvements, practices, methods, protocols, operating manuals, databases, compounds, chemical libraries, formulas, knowledge, trade secrets, technologies, processes, assays, sources, skills, experience, techniques, data and results of experimentation and testing (including, but not limited to, pharmacological, toxicological and pre-clinical and clinical test data and analytical and quality control data, patentable or otherwise) and regulatory filings. Know How includes Documents containing Know How, including but not limited to any rights including trade secrets, copyright, database or design rights protecting such Know How. The fact that an item is known to the public shall not be taken to preclude the possibility that a compilation including the item, and/or a development relating to the item, is not known to the public.

1.1.50 “ Law ” or “ Laws ” means all applicable laws, statutes, rules, regulations, orders, codes, judgments, guidance documents, and ordinances of any governmental authority, or securities listing authority such as a stock exchange.

1.1.51 “ Licence Agreement ” shall have the meaning given to it in Section 6.2.

1.1.52 “ Manufacturing Cost ” shall mean, other than for purposes of Section 6.3, GW Pharma’s manufacturing cost which shall comprise:

(a) in the case where manufacture is contracted to a Third Party by GW Pharma, any charge rendered by that Third Party for the manufacture or part of the manufacturing process of the Research Compound(s) in question; and in either case

(b) any other costs borne by GW Pharma for transportation, insurance and customs clearance and storage of the Research Compound(s) in question, at the request of Otsuka.

For clarity, where GW Pharma manufactures Research Compound(s) at its own growing and manufacturing facilities using its own FTEs its costs thereof will be FTE Costs not Manufacturing Costs.

1.1.53 “ Material ” shall mean any biological or chemical substance including any: (i) Research Compound; (ii) drug or pro-drug; (iii) assay or reagent; and (iv) any other biological material.

1.1.54 “ Net Sales ” shall mean the gross amount invoiced by a Party, its Affiliates and sublicensees for all sales of a Royalty Bearing Products to Third Parties during a relevant period, less the following items arising during the same relevant period regardless as to whether they are related to the same sales: (i) discounts, including cash and quantity discounts and adjustments arising from consumer discount programs actually paid, granted or accrued and required distribution commissions/fees granted or given to wholesalers or other distributors, all of the foregoing to the extent reasonable and customary, (ii) amounts for credits, rebates or allowances for price adjustments including chargeback payments and rebates or fees granted or given to buying groups, healthcare insurance carriers, managed healthcare organizations or to federal, state, or local governments (or their respective agencies, purchasers, and reimbursers) or to trade customers, billing errors, damaged or defective goods, rejections or returns of Royalty Bearing Products not replaced, including recalls or withdrawals of a Royalty Bearing Product where such amounts in any period are good faith estimates that reflect the position in previous periods, if any, and will be the same amounts used for the purposes of the audited amounts of that Party, its Affiliates and sublicensees (iii) freight, postage, shipping and

insurance charges actually allowed or paid for delivery of Royalty Bearing Products, to the extent actually billed, and (iv) taxes, duties, or other governmental charges (other than income taxes) actually levied on, or otherwise imposed on sales of Royalty Bearing Products.

Net Sales of any Royalty Bearing Product that is sold as a Combination Product will be determined by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average price paid for the Royalty Bearing Product when sold separately in finished form in the relevant county and B is the sum of the average prices paid for products containing the other active ingredients in the Combination Product when sold separately in finished form in the relevant country. If such average invoice prices cannot be determined for both the Royalty Bearing Product and the product(s) containing such other ingredient(s) and in all cases where the Combination Product contains a proprietary delivery system where the Third Party is due a payment upon the sale of such Combination Product, the Parties will negotiate in good faith regarding the calculation of Net Sales for the applicable Combination Product, based on the relative value contributed by each component.

Each of the foregoing deductions shall be determined as incurred in the ordinary course of business and in accordance with GAAP in the case of Otsuka or IAS in the case of GW Pharma. All deductions for payments in respect of sales to any governmental authority, any government subsidized program, or any managed care or similar organization, which deductions apply collectively to multiple pharmaceutical products, shall be fairly allocated to the amounts invoiced for Royalty Bearing Products.

1.1.55 “ Otsuka ” shall have the meaning provided in the introductory paragraph to this Agreement.

1.1.56 “ Otsuka Scientists ” shall mean the scientists employed by Otsuka who may, at Otsuka’s option, be placed during the Research Collaboration at the facilities of GW Pharma’s collaborator, the University of Aberdeen located in Aberdeen, Scotland, with which GW Pharma is entering into a collaboration

agreement to be entered into on or about the Effective Date pursuant to which GW Pharma has conducted cannabinoid research at the University of Aberdeen. The Otsuka Scientists shall number no more than three (3) scientists at any one time although Otsuka may change the individual scientists on giving written notice to GW Pharma and so long as (i) Otsuka consults with GW Pharma regarding such substitution and the identity and qualifications of the replacement Otsuka scientist prior to making such change, and (ii) any replacement Otsuka Scientist complies with the requirements of Section 3.3.1.

1.1.57 “ Patent Rights ” shall mean:

(a) all national, regional and international patents and patent applications, including provisional patent applications,

(b) all patent applications filed either from such patents, patent applications or provisional applications or from an application claiming priority from any of these, including divisionals, continuations, continuations-in-part, provisionals, converted provisionals, and continued prosecution applications,

(c) any and all patents that have issued or in the future issue from the foregoing patent applications (a) and (b), including author certificates, inventor certificates, utility models, petty patents and design patents and certificates of invention,

(d) any and all extensions or restorations by existing or future extension or restoration mechanisms, including revalidations, reissues, re-examinations and extensions (including any supplementary protection certificates and the like) of the foregoing patents or patent applications (a), (b) and (c), and

(e) any similar rights, including so-called pipeline protection, or any importation, revalidation, confirmation or introduction patent or registration patent or patent of additions to any such foregoing patent applications and patents.

1.1.58 “ Parties ” means GW Pharma and Otsuka and “Party” means either of GW Pharma or Otsuka, but shall not include GW Pharmaceuticals plc save for the purposes of Section 17.

1.1.59 “ Person ” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, incorporated association, joint venture or similar entity or organization, including a government or political subdivision, department or agency of a government.

1.1.60 “ Phase I Clinical Study ” means a clinical study in human volunteers or patients with the endpoint of determining initial tolerance, toxicity, safety and/or pharmacokinetic information, including a clinical study that would satisfy the requirements of 21 C.F.R. 312.21(a) or an equivalent clinical trial in a country other than the USA.

1.1.61 “ Phase IIa Clinical Study ” shall mean a human clinical trial for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. §312.21, or an equivalent clinical trial in a country other than the USA or an equivalent clinical trial in a country other than the USA.

1.1.62 “ Phytocannabinoid ” shall have the meaning given to it in Section 1.1.6.

1.1.63 “ Pre -Licence Development ” shall mean all development activities with respect to Research Compounds prior to designation as Product Candidates and the execution and delivery of Licence Agreements relating thereto, as contemplated in Section 6.3. For clarity Pre-Licence Development includes the conduct of the Initial Pharmacological Evaluation Studies, the Pre-Clinical Studies, the Early Clinical Evaluation Studies and the generation of the Developmental CMC Data.

1.1.64 “ Pre-Clinical Studies ” shall mean GLP in vitro and in vivo pre-clinical studies of Research Compounds conducted for the purpose of evaluating the desirability to Otsuka of choosing such Research Compounds as Product Candidates, but excluding the Initial Pharmacological Evaluation Studies, the

Early Clinical Evaluation Studies and the generation of the Developmental CMC Data.

1.1.65 “ Product ” shall mean any pharmaceutical preparation containing a Product Candidate for which Regulatory Approval has been sought and is in the process of being obtained, or has been obtained, as the context requires.

1.1.66 “ Product Candidate ” shall mean any Selected Drug Candidate chosen by Otsuka for Clinical Development in light of the results obtained for such Selected Drug Candidate from the Pre-Clinical Studies and/or Early Clinical Evaluation Studies conducted with respect thereto under the Research Collaboration. For clarity this includes any Selected Drug Candidate that is a Synthetic Cannabinoid Product that is Covered by Collaboration IP or GW Pharma Background IP. In this Section “chosen” means that all necessary internal approvals of Otsuka have been given for the commencement of Clinical Development in relation to the relevant Product Candidate.

1.1.67 “ Qualifying Pharmaceutical Company ” shall mean any publicly listed company trading as a pharmaceutical or biotechnology company with a market capitalization of more than US$***, to be assessed on the day prior to the closure of the Change of Control.

1.1.68 “ Recipient Party ” shall mean the Party which receives Confidential Information from the other Party.

1.1.69 “ Regulatory Approval ” shall mean any approval required from a Regulatory Authority to market and sell a Product in any country of the Territory including any approval for a label extension or new indication and including any pricing or reimbursement approval.

1.1.70 “ Regulatory Authority ” shall mean any national, supranational, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA in any country involved in the granting or receipt as the case may be of INDs or Regulatory Approvals.

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1.1.71 “ Research Budget ” has the meaning given to it in Section 8.1.

1.1.72 “ Research Collaboration ” shall mean the research and activities to be undertaken by GW Pharma and Otsuka respectively under this Agreement pursuant to and in accordance with the terms of this Agreement and the Research Plan during the Research Term and any Extended Research Term for the purpose of conducting research and Pre-License Development activities regarding Research Compounds to identify Product Candidates in the Research Field. For clarity, the Research Collaboration includes (i) the conduct of all agreed Initial Pharmacological Evaluation Studies, Pre-Clinical Studies and Early Clinical Evaluation Studies carried out prior to the final selection by Otsuka of Product Candidates for Clinical Development, and (ii) any activities carried out by or on behalf of GW Pharma and Otsuka pursuant to the Research Plan, regardless of who pays for such activities.

1.1.73 “ Research Compounds ” shall mean collectively, all Selected BDCs and Selected Drug Candidates. For clarity, Research Compounds shall include Synthetic Cannabinoids synthesized under the Research Plan and which subsequently become Selected BDCs and/or Selected Drug Candidates.

1.1.74 “ Research Costs ” shall mean the costs and expenses incurred by GW Pharma under the Research Collaboration and to be reimbursed to GW Pharma from the Research Fund comprised of FTE Costs, Third Party Costs, Equipment Costs and Manufacturing Costs.

1.1.75 “ Research Field ” shall mean the treatment, diagnosis, prevention, or palliation of (i) diseases, conditions, syndromes, and maladies of the central and peripheral nervous systems of humans and animals and (ii) cancer in humans and animals. The Research Field may by mutual agreement of the Parties (not the JRC) from time to time be expanded to include other diseases and conditions. The Research Field shall be deemed to include all research activities contemplated by any Research Plan approved by Otsuka as a member of the JRC, provided that the overall objective of such Research Plan is consistent with a research plan for the research, identification and early development of Research Compounds in the Research Field.

1.1.76 “ Research Fund ” shall mean the fund of money to be provided by Otsuka to be used over the Research Term, or if applicable the Extended Research Term, to fund the performance of the Research Plan. Initially, the Research Budget for the conduct of the three (3) year Research Plan shall be *** U.S. dollars ($***) but this amount may be increased from time to time by Otsuka in order to cover research and Pre-Licence Development activities to be performed during the Research Term, or if applicable the Extended Research Term.

1.1.77 “ Research Plan ” shall mean the written document prepared in advance of each Research Year and agreed upon by the JRC in accordance with the procedure set out in Section 2.2.2 that sets forth in detail the research and Pre-Licence Development activities (and each Party’s responsibilities for performing such activities) to be conducted in such Research Year (including timelines), the Research Budget therefor and milestones to be achieved in such Research Year. The Research Plan for the first Research Year is set out in Schedule 1.1.77 to this Agreement. The Research Plan for a particular Research Year may be amended from time to time upon written agreement of the JRC.

1.1.78 “ Research Term” shall mean a period commencing on the Effective Date and expiring at the end of (a) the third Research Year (30 June, 2010) or (b) the fourth Research Year (30 June, 2011) in the event that Otsuka elects to extend the Research Term by notice thereof to GW Pharma within one-hundred twenty (120) days following receipt by the JRC Members of GW Pharma’s research report pertaining to the second Research Year delivered by GW Pharma to the JRC pursuant to Section 3.4.5. Funding for the fourth Research Year, if any, shall not be less than that devoted to the third Research Year. At the written request of either Party during the third Research Year, or the fourth Research Year, if there be a fourth Research Year, such request to be made on or before one hundred eighty (180) days prior to the end of such third Research Year or fourth Research Year, as the case may be, GW Pharma and

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Otsuka shall promptly discuss whether, and upon what basis, the Research Term should be extended for additional Research Year(s). Neither Party shall have any obligation to agree to any such extension, but if any such extension is mutually agreed it shall become the “ Extended Research Term ”. The level and extent of Research Collaboration activities to be conducted by GW Pharma during the fourth Research Year or the Extended Research Term, and the level of Otsuka’s funding, during any Extended Research Term, if any, shall be mutually agreed in writing by the Parties.

1.1.79 “ Research Year ” shall mean a period of twelve (12) months commencing on 1 July in a calendar year and ending on the 30 June in the subsequent calendar year during the Research Term and any Extended Research Term, provided however that the Research Year in which the Effective Date occurs shall extend from the Effective Date until the 30 June 2008.

1.1.80 “Royalty Bearing Product” shall mean a GW Pharma Product, a Synthetic Molecule Product and a Type 2 Synthetic Cannabinoid Product.

1.1.81 “SAB Costs” shall have the meaning set out in Section 2.6.

1.1.82 “ Sativex Licence Agreement ” shall mean the Development and Licence Agreement between GW Pharma and Otsuka entered into on February 14th, 2007, under which GW Pharma licensed Otsuka to develop and commercialize GW Pharma’s lead product, SATIVEX TM oromucosal spray, for the USA market.

1.1.83 “ Scientific Advisory Board ” or “ SAB ” shall mean the advisory board to be established pursuant to Section 2.4.

1.1.84 “ Selected BDC ” shall mean either (a) a BDC selected by the JRC from among all BDCs possessed by GW Pharma during the Research Term or the Extended Research Term, after taking into account all relevant data and information pertaining to such BDC contained in GW Pharma’s associated BDC Data Package, to be the subject of further research (including cannabinoid extract preparation, analysis, characterization and testing) and/or Initial

Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies under the Research Collaboration; or (b) Synthetic Cannabinoids synthesized under the Research Plan and which are subsequently selected for further research (including cannabinoid preparation, analysis, characterization and testing) and/or Initial Pharmacological Evaluation Studies and so are Covered by Collaboration IP and/or GW Pharma Background IP.

1.1.85 “ Selected Drug Candidate ” shall mean any Selected BDC chosen by the JRC to undergo Type 2 Pre-Clinical Studies and/or Early Clinical Evaluation Studies in light of the results obtained for such Selected BDC from the Initial Pharmacological Evaluation Studies and the Type 1 Pre-Clinical Studies. Any Selected BDC(s) in respect of which the JRC agrees to forego Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies and to move directly into Type 2 Pre-Clinical Studies and/or Early Clinical Evaluation Studies shall be deemed to be a Selected Drug Candidate.

1.1.86 “ Specifications ” shall mean the specifications to which a Research Compound is to be manufactured by GW Pharma as agreed by the JRC from time to time pursuant to Section 2.2.11.

1.1.87 “ Synthetic Cannabinoid ” shall mean any Phytocannabinoid produced by synthetic methods either (i) pursuant to a Research Plan (a “ Type 1 Synthetic Cannabinoid ”) or (ii) outside of the Research Collaboration but with information resulting from the Research Collaboration (“ Type 2 Synthetic Cannabinoid ”).

1.1.88 “ Synthetic Cannabinoid Product ” shall mean any pharmaceutical product containing a Type 1 Synthetic Cannabinoid (“ Type 1 Synthetic Product ”) or a Type 2 Synthetic Cannabinoid (“ Type 2 Synthetic Cannabinoid Product ”). If the active ingredient in a pharmaceutical product first sold commercially within *** years following the Research Term or the Extended Research Term, as the case may be, by or on behalf of Otsuka , other than pursuant to a License Agreement or a license from a Third Party, contains a Phytocannabinoid produced by synthetic methods it will be assumed that such Phytocannabinoid is a *** Synthetic Cannabinoid (and therefore that the product in question is a *** Synthetic Cannabinoid Product) until Otsuka can produce evidence acceptable to GW Pharma (acting reasonably) which demonstrates that the active ingredient in such product was developed without using information resulting from the Research Collaboration.

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1.1.89 “ Synthetic Molecule ” shall mean a synthetic molecule whose chemistry is not based on a Phytocannabinoid but (i) which has been developed with information resulting from the Research Collaboration and (ii) for which one or more patent applications have been filed by Otsuka on an invention conceived within *** years following expiration of the Research Term or any Extended Research Term claiming (a) a novel composition of matter and (b) a *** effect through direct or indirect (i.e. modulation of related metabolic enzyme systems), effects on one or more cannabinoid receptors (including their allosteric sites).

1.1.90 “ Synthetic Molecule Product ” shall mean any pharmaceutical product containing a Synthetic Molecule. If the active ingredient in a pharmaceutical product first sold commercially within *** years following the Research Term or the Extended Research Term, as the case may be, by or on behalf of Otsuka, other than pursuant to a license from a Third Party, has a *** effect through direct, or indirect (i.e. modulation of related metabolic enzyme systems), effects on one or more cannabinoid receptors (including their allosteric sites), it will be assumed that such active ingredient in such product is a Synthetic Molecule and therefore that the product in question is a Synthetic Molecule Product) until Otsuka can produce evidence acceptable to GW Pharma (acting reasonably) which demonstrates that the active ingredient in such product was developed using information resulting from the Research Collaboration.

1.1.91 “ Territory ” shall mean the world.

1.1.92 “ THC ” shall mean delta-9-tetrahydrocannabinol.

1.1.93 “ Third Party ” shall mean any entity other than Otsuka or GW Pharma or an Affiliate of Otsuka or GW Pharma.

1.1.94 “ Third Party Costs ” shall mean any costs incurred in relation to any research or Pre-Licence Development activity performed pursuant to a Research Plan and contracted to any Person not including the Parties or the Parties’ respective Affiliates including consultants, research fellows, scientific and clinical advisers, clinical research organizations, clinical researchers and/or statisticians but always excluding Manufacturing Costs.

1.1.95 “ Type 1 Pre-Clinical Studies ” shall mean those Pre-Clinical Studies comprising the ***.

1.1.96 “ Type 2 Pre-Clinical Studies ” shall mean all Pre-Clinical Studies other than Type 1 Pre-Clinical Studies.

1.1.97 “ USA ” shall mean the United States of America, its territories and possessions.

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1.1.98 “ Valid Claim ” shall mean either:

(a) a claim of an issued and unexpired patent included within Patent Rights, which has not been held permanently revoked, unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or un-appealed within the time allowed for appeal, and which has not been admitted to be invalid or unenforceable through reissue or disclaimer or otherwise; or

(b) a claim of a pending patent application included within Patent Rights which claim was filed and is being prosecuted in good faith and has not been abandoned or finally disallowed without the possibility of appeal or refiling of the application, provided that no more than five (5) years have passed since the earliest priority date for such application.

2. GOVERNANCE

2.1 Establishment of the Joint Research Committee. With effect from the Effective Date the Parties shall establish and run a Joint Research Committee (“ JRC ”) as the principal organ of governance of the implementation of the objectives of this Agreement including to provide liaison, communication and strategic and planning decision making with regard to the research and Pre-Licence Development of Research Compounds and the direction and conduct of the GW/Otsuka CRI as follows:-

2.1.1 the JRC shall comprise four (4) persons (“ JRC Members ”) and GW Pharma and Otsuka respectively shall be entitled to appoint two (2) JRC Members, to remove any JRC Member appointed by it and to appoint any person to fill a vacancy arising from the removal or retirement of such JRC Member appointed by it. Each JRC Member may designate a stand-in from time-to-time as exigencies dictate. GW Pharma’s initial JRC Members will be ***. Otsuka’s initial JRC Members will be ***. JRC Members must be appropriate

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for the primary function of the JRC in terms of their seniority, availability, function in their respective organization, training and experience. The Parties may adjust their JRC Members over time to reflect the progress of Research Collaboration. Otsuka and GW Pharma respectively shall each notify the other of any change in the identities of their JRC Members. There will be a chairperson of the JRC (“ JRC Chairperson ”) who will be chosen by GW Pharma from among its JRC members; and

2.1.2 the venue for meetings of the JRC shall be the premises of GW Pharma or such other location within the UK as the Parties may agree from time to time, if not held by teleconference or videoconference. Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with JRC meetings; and

2.1.3 the JRC shall have power to invite persons whose special skills or influence might advance the research and Pre-Licence Development of Research Compounds, in confidence and upon behalf of the JRC, to attend and address meetings of the JRC. For clarity such persons shall not be JRC Members and shall not participate in the decision making process of the JRC; and

2.1.4 each of the Parties, as it sees fit, shall be entitled to bring such number of its employees and advisers to meetings of the JRC as observers; provided, however, that such observers shall be under an obligation of confidentiality to the Party with whom it is attending and the proceedings of the JRC shall be treated as confidential; and

2.1.5 the JRC Chairperson is responsible for promptly preparing the minutes of any JRC meeting, seeking unanimous approval of those minutes from the JRC Members, which approval shall be signified by the JRC Members or, in the alternative, the Parties signing and dating the minutes, and promptly distributing a copy of the approved minutes to each Party. It is only such signed and dated minutes which shall constitute a decision of the JRC.

2.2 Function of the JRC. The JRC shall:-

2.2.1 hold meetings in person as frequently as the JRC Members may agree shall be necessary and otherwise by teleconference or a video-conference but in any event no less frequently than four (4) times a Research Year or pursuant to such other schedule as the Parties may agree. Dates of meetings shall be agreed by the Parties; responsibility for arranging the meetings, including, at least, providing notice and an agenda, shall be the responsibility of the JRC Chairperson. The Chairperson shall circulate the proposed agenda among the JRC Members no later than fourteen (14) days prior to the JRC meeting, and the JRC Members shall be entitled to add items to the agenda in their reasonable discretion. No later than seven (7) days prior to each meeting of the JRC the agenda for such meeting shall be established, and each Party will provide the other with written copies of all materials such Party intends to present at the JRC meeting. The first meeting of the JRC will take place as soon as practicable after the Effective Date, but in no event later than thirty (30) days after the Effective Date. In addition, special meetings of the JRC may be called by any JRC Member upon written request to the Chairperson of the JRC;

2.2.2 on or before the end of the third quarter in each Research Year until the end of the Research Term and any Extended Research Term, generate and agree the Research Plan setting out the detailed activity to be carried out by the Parties during the next Research Year taking into account the amount of the Research Fund remaining which Research Plan must contain a fully costed Research Budget for the relevant period. Once prepared and agreed upon, such Research Plan and associated Research Budget shall be submitted to the Parties for approval. The JRC may change the Research Plan for a particular Research Year during the course of that Research Year as it considers appropriate from time to time as long as each change is reduced to writing and signed and dated by the Parties once agreement has been reached on the written form of such change (whether under Section 2.3 or the dispute resolution process to which it refers). The JRC shall retain copies of all such authorized versions of each Research Plan (including each Research Budget) and each shall become incorporated in this Agreement as of the date of signature by last Party to sign;

2.2.3 determine which BDCs shall form the subject of the Research Collaboration having assessed their suitability therefor including taking into account the BDC Data Package relating thereto provided by GW Pharma;

2.2.4 determine the target indications for which such Selected BDCs are to undergo research and Pre-Licence Development in the Research Field and thereafter shall agree the Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies ( if any) to be undertaken with respect to such Selected BDCs for the applicable target indication. Such decisions and the Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies ( if any) to be undertaken with respect to such Selected BDCs shall be incorporated into the relevant Research Plan(s);

2.2.5 based upon the results of the Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies or otherwise, determine which Selected BDCs should be designated as Selected Drug Candidates and which Selected BDCs should not be selected as Selected Drug Candidates and thereafter shall agree upon the Type 2 Pre-Clinical Studies to be conducted with respect to the Selected BDCs designated as Selected Drug Candidates including the Parties’ respective activities, and the timing, duration and location of such studies. Such decisions and the Type 2 Pre-Clinical Studies to be undertaken with respect to such Selected Drug Candidate(s) shall be incorporated into the relevant Research Plan(s);

2.2.6 determine which Early Clinical Evaluation Studies are to be conducted, and by which Party, with respect to the Selected Drug Candidate(s) and whether these studies should be conducted inside the UK or outside the UK. Such decisions and the Early Clinical Evaluation Studies to be undertaken with respect to such Selected Drug Candidate(s) shall be incorporated into the relevant Research Plan(s);

2.2.7 following its review of the reports submitted to in pursuant of Sections 3.4.4 and 3.4.5 and at such other times as it sees fit, determine whether the research and Pre-Licence Development of any Research Compound should be discontinued; should the JRC decide to discontinue the research and Pre-

Licence Development of any Research Compound the JRC shall make the amendments to the relevant Research Plan(s) (including the Research Budget(s)) which are necessary to reflect the discontinued research and Pre-Clinical Research Activities with respect to this Research Compound.

2.2.8 determine which cannabinoid researchers, academic institutions and other Third Party organizations GW Pharma may (i) enter into collaborative research agreements with for the purposes of carrying out certain Initial Pharmacological Evaluation Studies and such other studies as a Research Plan may specify or the Parties may agree, and (ii) enter into consultancy or other advisory relationships for the purposes of the Research Collaboration in the Research Field;

For clarity, in making its decisions under Sections 2.2.2 through 2.2.8 inclusive the JRC may consider the commercial opportunity offered by the relevant BDCs and Research Compounds as part of their assessment of the viability of (i) BDCs when deciding if they should be selected as Selected BDCs, and (ii) Selected BDCs when deciding if they should be selected as Selected Drug Candidates;

2.2.9 review progress reports on the Research Collaboration and performance of each Research Plan from the Parties prepared pursuant to Sections 3.4.4 and 3.4.5;

2.2.10 (i) receive disclosures from the Parties of any inventions conceived pursuant to the Research Collaboration and (ii) cause each of the Parties’ patent attorneys (as appointed by them) to advise upon the possibility of filings for Joint Patent Rights being made thereon, and, if so possible, when and where such patent filings should be made and ensure that such patent filings are made, and (iii) through discussion with the Parties’ patent attorneys make initial determinations of inventorship prior to filing of the application for Joint Patent Rights;

2.2.11 set the manufacturing specifications pertaining to both the non-cGMP and cGMP manufacture of the Research Compounds to be manufactured by GW Pharma and supplied for the purposes of the Research Collaboration (the “ Specifications ”) and any changes necessary or desirable thereto from time to

time. For clarity the JRC shall not have the power to divest GW Pharma under this Agreement as the manufacturer of Research Compound for use in the Research Collaboration, which right is reserved to, and shall be the obligation of, GW Pharma;

2.2.12 establish all necessary rules, standard operating procedures and policies, including policies regarding intellectual property creation and disclosure necessary for the Research Collaboration;

2.2.13 coordinate the establishment of the SAB as soon as practicable following the Effective Date and thereafter shall coordinate the organization of the SAB meetings, and set the agenda for the SAB meetings; and

2.2.14 no later than thirty (30) days prior to the expiration of the Research Term and any Extended Research Term, meet to review the status of all activities then being conducted under the auspices of the JRC. The JRC shall hold a special meeting to review the status of such activities if required; and

2.2.15 perform such other functions and responsibilities as are given to it under the express provisions of this Agreement but shall have no authority to amend any commercial terms of this Agreement or any matter that would cause any payments stated in this Agreement to be other than the amount of those terms as stated herein.

2.3 Decision making and Dispute Resolution. Conclusions and decisions of the JRC shall be made by unanimous agreement of the JRC Members wherever possible with Otsuka JRC Members together having one vote on behalf of Otsuka and GW Pharma JRC Members together having one vote on behalf of GW Pharma. Both Parties will use their reasonable efforts to build consensus. The JRC may consult with the SAB prior to making its decisions under Sections 2.2.2 to 2.2.8. All decisions of the JRC shall be minuted by or on behalf of the JRC Chairperson who shall seek unanimous approval of those minutes from the JRC Members, which minutes will be approved in accordance with the procedures set out in Section 2.1.5. The JRC shall exercise its authority in good faith and in accordance with the terms of this Agreement, and any decision by the JRC on such matters made in accordance with this Section 2.3 shall be binding upon the Parties, subject to the application of the following sentence. In the

event that agreement on a matter cannot be reached within fourteen (14) days then, save in respect of the matters set out in Section 2.3.1 and 2.3.2, the final decision shall be Otsuka’s, which shall be exercised in good faith. Any such agreement or resolution in this way shall for the purposes of this Agreement be in writing and shall be conclusive and binding on the Parties. Matters before the JRC that shall require the agreement of both Parties are:

2.3.1 any increase in the number of GW Pharma FTEs working on the Research Collaboration resulting from material changes to a Research Plan; and

2.3.2 establishment of the Specifications for any Research Compound including any changes thereto,

and if agreement cannot be reached by the JRC in relation to any of these issues the Agreement shall remain unchanged. The Parties shall confer in an effort to resolve their differences of opinion regarding the preferred outcomes of matters contemplated by Section 2.3.1 and 2.3.2. They shall exercise good faith and reasonableness in pursuing the resolution of such matters and each of them shall give due regard to the other’s views.

2.4 Establishment of the Scientific Advisory Board. As soon as practicably possible following the Effective Date, the Parties, coordinated by the JRC, will establish the Scientific Advisory Board. The purpose of the SAB will be to suggest promising directions for the Research Collaboration. The SAB will comprise up to six (6) scientists. The members of the SAB will be made up of a selection of (i) world-leading scientists in the field of cannabinoids and cannabinoid research and (ii) experts in other related fields and disciplines. GW Pharma shall generate a list of ten (10) candidate names to be invited to be members of the SAB. This list will be forwarded to Otsuka for review and approval. Following Otsuka’s approval, GW Pharma shall be responsible for contacting its nominated candidates. This process shall be repeated until GW Pharma has identified at least six (6) candidates who are prepared to join the SAB. Otsuka may nominate one or more scientists or experts to be invited to be a member of the SAB. The form and substance of all agreements and arrangements entered into with members of the SAB shall be subject to the reasonable consent of the JRC.

2.5 Meetings of the Scientific Advisory Board. The SAB shall meet with such frequency and at such places as the JRC may agree, with the understanding that it is the intention of the Parties that the SAB generally will meet twice a year in Europe or the USA.

2.6 Funding of the Scientific Advisory Board. The costs and expenses of the SAB shall be drawn from the Research Fund (“ SAB Costs ”).

3. ESTABLISHMENT AND CONDUCT OF THE RESEARCH COLLABORATION

3.1 Disclosure and Selection of Botanical Drug Candidates.

3.1.1 GW Pharma shall provide to Otsuka, as soon as reasonably practicable following the Effective Date, (a) a list of all BDCs within its Control for selection by the JRC as Selected BDCs, and (b) a BDC Data Package for each such BDC. Thereafter GW Pharma shall, from time to time during the Research Term and any Extended Research Term, notify Otsuka in writing of any additional BDCs which come under the Control of GW Pharma from which additional selections may be made. Such notification shall be accompanied by a BDC Data Package for each BDC the subject of such a notice.

3.1.2 At the first JRC meeting held subsequent to either GW Pharma’s disclosure of a given BDC for selection as a Selected BDC or the synthesis of a Synthetic Cannabinoid within the Research Collaboration, provided, however, that the BDC Data Package pertaining to such BDC or relevant data pertaining to such Synthetic Cannabinoid shall have been in the possession of all of the JRC Members no less than twenty-one (21) days prior to such meeting, the JRC shall consider the BDC Data Package for each such BDC, or in the case of such a Synthetic Cannabinoid shall consider the relevant data, and shall, on a case by case basis, decide at that meeting: whether at such time to designate the BDC or Synthetic Cannabinoid as a Selected BDC. If the JRC decides to designate it as a Selected BDC it will then discuss, and as promptly as practicable, agree upon the target indication(s) with respect to which the Selected BDC should undergo research and Pre-Licence Development and the

Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies to be conducted with respect thereto and make the necessary amendments to the then current Research Plan (including the Research Budget) to incorporate these Initial Pharmacological Evaluation Studies into the Research Plan. Should the JRC decide that there is no need for Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies with respect thereto, the JRC may select such BDC or Synthetic Cannabinoid to become a Selected Drug Candidate immediately, in which case the provisions of Section 3.2 shall apply. If the JRC fails to designate a BDC as a Selected BDC, such BDC shall not at that time become a Research Compound and GW Pharma shall be clear to use (or continue using) pursuant to Section 7.2 such BDC in any way it chooses outside the Research Field thereafter without any obligation to Otsuka save as set out in Section 7.2 and further subject to the right of the JRC to return at any time during the Research Term or Extended Research Term to designate such BDC as a Selected BDC.

3.1.3 Any Initial Pharmacological Evaluation Studies which the JRC decides should be conducted with respect to a Selected BDC shall be conducted by either: (i) Otsuka and GW Pharma, whether with the contribution of the Otsuka Scientists at the University of Aberdeen or otherwise, and/or (ii) GW Pharma, alone or in conjunction with Third Parties collaborators approved by the JRC, and GW Pharma shall enter into collaborative agreements with select cannabinoid researchers and universities and other institutions as agreed by the JRC for the purposes of carrying out certain Initial Pharmacological Evaluation Studies.

3.2 Selected Drug Candidates

3.2.1 At the first JRC meeting held subsequent to the completion of Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies with respect to a Selected BDC, provided, however, that all relevant data pertaining to such Selected BDC (including the data contained in the reports submitted to the JRC pursuant to Sections 3.4.4 and 3.4.5) have been in the possession of all JRC Members for not less than twenty-one (21) days prior to such meeting, the JRC shall consider all such data and decide at that meeting either: (i) to

designate that Selected BDC as a Selected Drug Candidate; (ii) that further Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies are required with respect thereto, or (iii) to decline at such time to do either of (i) or (ii). If the JRC decides to designate a Selected BDC as a Selected Drug Candidate it will then discuss and, as promptly as practicable, agree upon a detailed plan of Type 2 Pre-Clinical Studies and/or Early Clinical Evaluation Studies to be conducted with respect thereto (including the locations at which such studies should be conducted and the time frame within which they should be conducted), the Development CMC Data to be generated with respect thereto and make the necessary amendments to the then current Research Plan (including the Research Budget) to incorporate such Type 2 Pre-Clinical Studies, Early Clinical Evaluation Studies and the development of the Developmental CMC Data. If, upon completion of the relevant Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies and the JRC’s analysis of the relevant data the JRC decides that further Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies are required with respect thereto it will then discuss and, as promptly as practicable, agree upon the additional Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies to be conducted with respect thereto and make the necessary amendments to the then current Research Plan (including the Research Budget) to incorporate these Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies. If after these additional Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies have been conducted the JRC is still not satisfied that the relevant Selected BDC should be designated as a Selected Drug Candidate, the JRC may conduct additional Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies or decline at such time to designate a Selected BDC as a Selected Drug Candidate, in which case the provisions of the following sentence shall apply. If the JRC decides that the Selected BDC does not have the necessary characteristics to be designated as a Selected Drug Candidate and decides at any time not to conduct further Initial Pharmacological Evaluation Studies and/or Type 1 Pre-Clinical Studies with respect thereto or declines to designate such Selected BDC as a Selected Drug Candidate, such Selected BDC shall not at that time become a Selected Drug

Candidate and GW Pharma shall be clear to use (or continue using) such Selected BDC in any way it chooses outside the Research Field thereafter without any obligation to Otsuka save as set out in Section 7.2 and further subject to the right of the JRC to return at any time during the Research Term or Extended Research Term to designate such Selected BDC as a Selected Drug Candidate.

3.2.2 Early Clinical Evaluation Studies shall be conducted in accordance with the provisions of Section 5.

3.2.3 Any Pre-Clinical Studies which the JRC decides should be conducted with respect to a Research Compound shall be conducted by, or on behalf of, Otsuka, which for clarity may be by GW Pharma or a nominee on behalf of Otsuka, at Otsuka’s sole cost and expense. Any Developmental CMC Data which the JRC decides should be generated with respect to a Selected Drug Candidate (including any stability data) and any Early Clinical Evaluation Studies which the JRC decides GW Pharma should conduct will be generated or conducted (as applicable) by GW Pharma, with the Research Costs incurred by GW Pharma in developing such Developmental CMC Data and conducting such Early Clinical Evaluation Studies (whether FTE Costs, Equipment Costs, Manufacturing Costs or Third Party Costs) being included in the Research Budget and being paid to GW Pharma from the Research Fund in accordance with the provisions of Section 8.

3.3 Otsuka Scientists

3.3.1 Conduct

(a) During the Research Term and any Extended Research Term, GW Pharma will permit the Otsuka Scientists to work with GW Pharma and its approved collaborators at the University of Aberdeen and to be directly and fully involved, on an ongoing and collaborative basis in the research and Pre-Licence Development activities to be conducted by GW Pharma pursuant to the Research Plans, in the fields specified in Section 3.3.2 below.

(b) The Parties, acting through the JRC, shall establish all necessary rules and policies, including policies regarding intellectual property creation and disclosure to which the Otsuka Scientists must adhere; provided, however, such policies must permit such Otsuka Scientists to communicate both with GW Pharma’s scientists (including those of its collaborators) and with Otsuka on an ongoing basis regarding the activities conducted by the Otsuka Scientists under the Research Plans.

(c) On the Effective Date Otsuka will notify GW Pharma in writing of the names of the initial Otsuka Scientists. These scientists must be at least graduate or similarly qualified employees of Otsuka and must have the requisite skills, including spoken and written English language skills, to perform the activities for which they will be responsible pursuant to Section 3.3.2. Otsuka may change the Otsuka Scientists from time to time following consultation with GW Pharma regarding such substitution and the identity and qualifications of any replacement Otsuka Scientist prior to making such change and on giving GW Pharma notice in writing of such change following such consultation. Should GW Pharma or the University of Aberdeen reasonably object to the presence of one or all of the Otsuka Scientists then present on its premises, such objection to be supported by reasons given in writing, Otsuka shall remove that Otsuka Scientist from the facilities of the University of Aberdeen promptly and replace that Otsuka Scientist with another employee of Otsuka who is qualified pursuant to the requirements of this Section 3.3.1(c).

(d) promptly after the Effective Date GW Pharma shall allow (and shall procure that its relevant collaborators allow) the Otsuka Scientists access to the premises in which they are to perform their allotted activities under each Research Plan subject to the following terms and conditions:

(i) prior to arriving at the University of Aberdeen, each Otsuka Scientist shall have executed a confidentiality agreement pertaining to confidential information pertaining to or arising

pursuant to the Research Collaboration with Otsuka in form and substance reasonably acceptable to GW Pharma. Otsuka hereby guarantees the performance of each Otsuka Scientist pursuant to such agreement executed by him or her. The breach by any Otsuka Scientist of such agreement executed by her or him shall be deemed to be a breach by Otsuka of this Agreement; and

(ii) the Otsuka Scientists, while at the University of Aberdeen, shall (a) observe and comply with GW Pharma’s or the University of Aberdeen’s facility access, health and safety and other customary regulations and policies, as applicable, and (b) not access areas of GW Pharma’s or the University of Aberdeen’s research premises for which they are not expressly authorized by GW Pharma or the University of Aberdeen.

3.3.2 Allocated Responsibilities. Whilst present at the University of Aberdeen, the Otsuka Scientists will be assigned to such research project groups of GW Pharma (or its designated collaborator) working under the Research Collaboration in the fields of: (i) ***, (ii) ***, (iii) ***, to perform the activities allocated to Otsuka under each Research Plan with respect to these therapeutic areas. The Parties may expand the therapeutic areas in which the Otsuka Scientists may collaborate with GW Pharma scientists from time to time.

3.3.3 Funding of Otsuka Scientists. Otsuka shall bear all the costs arising from and otherwise associated with the Otsuka Scientists in the performance by the Otsuka Scientists of the research and Pre-Licence Development activities allocated to Otsuka. The cost of the compensation, benefits and personal expenses of the Otsuka Scientists whilst present at the University of Aberdeen, and any other costs associated with or generated by the Otsuka Scientists through their performance of activities allocated to Otsuka (including the Cost

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of Work) shall be in addition to (and not part of) the Research Fund. If the Otsuka Scientists perform work under the Research Collaboration which has been allocated to GW Pharma, Otsuka shall continue to pay the compensation, benefits and personal expenses of the Otsuka Scientists, but GW Pharma shall pay, and be reimbursed from the Research Fund, for any additional expenses related to the performance of such work allocated to GW Pharma.

3.4 Conduct of the Research Collaboration

3.4.1 Each Party shall be responsible for performing its part of the Research Collaboration as follows:

(a) in accordance with the requirements of each Research Plan;

(b) performing or causing to be performed its tasks under each Research Plan with reasonable skill and care in good scientific manner and in compliance with GLP and GCP (where necessary) and in compliance in all material aspects with all other Laws. Any animals involved in any part of the Research Collaboration will be provided with humane care and treatment in accordance with current generally accepted veterinary practice; and

(c) keeping or causing to be kept accurate written laboratory notebooks and other records and reports of the progress of the Research Plan in sufficient detail and in good scientific manner for all purposes including patent purposes. Such notebooks and other records must properly reflect all work done on the Research Collaboration and the results achieved thereunder;

3.4.2 It is acknowledged that each Party shall have the right to make day-to-day operational decisions as to how to discharge its obligations within the framework of the Research Plan.

3.4.3 Each Party shall, subject to the prior consent of the other Party (such consent not to be unreasonable withheld or delayed), have the right to sub-contract the

whole of or part its responsibilities under a Research Plan. The appointment of any sub contractor shall be on the following terms:

(a) that as between the subcontracting Party and the sub-contractor, all results emerging from such work and any related intellectual property shall be owned by or exclusively licensed to the subcontracting Party; and

(b) that the sub-contractor shall be obligated in terms the same as Section 11 and Section 13.1.5.

3.4.4 With respect to the first three quarters in each Research Year, within thirty (30) days after the end of each such quarter, each Party shall provide the JRC with a written report regarding the Research Collaboration, the results generated by it under the Research Collaboration and not previously reported, any Collaboration IP generated, created, discovered or otherwise arising under the Research Collaboration and not previously reported by it and its progress under the then-current Research Plan against the timelines set out therein during the preceding quarter. The JRC shall set the format and nature of the content for such written quarterly reports.

3.4.5 Within thirty (30) days after the end of each Research Year, including the final Research Year of the Research Term and any Extended Research Term each Party shall provide an annual written report to the JRC covering its activities in the previous Research Year including all material activities conducted and results achieved by that Party under the Research Plan for that Research Year. The Parties shall mutually agree on the format for such written annual reports.

3.4.6 Each written report prepared by GW Pharma and submitted to the JRC pursuant to Sections 3.4.4 and 3.4.5 shall disclose in reasonable detail research, development and commercialization activities and progress of BDCs and Selected BDCs outside the Research Field.

4. MANUFACTURE AND SUPPLY OF RESEARCH COMPOUNDS

4.1 During the Research Collaboration GW Pharma shall be responsible for manufacturing or having manufactured all quantities of Research Compounds required to complete each Research Plan as follows:

4.1.1 GW Pharma shall manufacture Selected BDCs meeting the Specifications under non-cGMP conditions and provide a sufficient supply thereof to enable the Parties to conduct the Initial Pharmacological Evaluation Studies and the Type 1 Pre-Clinical Studies;

4.1.2 GW Pharma shall manufacture the Selected Drug Candidates meeting the Specifications under either non-cGMP or cGMP conditions (as agreed by the JRC) and provide a sufficient supply thereof to enable the Parties to conduct the Pre-Clinical Studies and Early Clinical Evaluation Studies.

4.2 GW Pharma’s Manufacturing Costs for the above Research Compounds will be reimbursed to GW Pharma from the Research Fund on the terms of Sections 8.1 and 8.2 as a Research Cost. For clarity, GW Pharma’s FTE Costs incurred in manufacturing such Research Compounds hereunder at its own growing and manufacturing facilities will be reimbursed from the Research Fund as FTE Costs rather than Manufacturing Costs. GW Pharma shall supply free of charge for use in the Research Collaboration such quantities of Research Compounds as may be in its possession at the Effective Date and which, in the judgment of GW Pharma, is available for purposes of this Agreement.

5. REGULATORY MATTERS

5.1 Unless otherwise agreed by the JRC INDs for the Early Clinical Evaluation Studies whether they are to be conducted inside or outside the UK shall be held by Otsuka regardless of the Party conducting such Early Clinical Evaluation Studies. Notwithstanding the foregoing it is a fundamental principle of this Agreement that the content of all material written documents, communications, submissions, calls (as may be reasonably practicable), conferences and meetings with the applicable Regulatory Authorities be discussed between the Parties in close consultation

including at the JRC or its relevant sub-committee before any of the same are made by Otsuka, whether or not GW Pharma otherwise participates in any of the same.

5.2 In relation to the Early Clinical Evaluation Studies to be conducted as part of the Research Collaboration:

5.2.1 The JRC shall determine the Party responsible for the design of the protocol, which design shall be subject to the reasonable consent of both Parties, and the Party responsible for the conduct of such Early Clinical Evaluation Studies shall also be determined by the JRC on a case by case basis, with the conduct of such Early Clinical Evaluation Studies to be performed in close consultation with the other Party as described in Section 5.1.

5.2.2 Otsuka shall be responsible for filing any IND covering Research Compounds in its own name and signed by it, the form and substance of such INDs being subject to the reasonable consent of GW Pharma, Otsuka having otherwise consulted with GW Pharma as described in Section 5.2.3. Otsuka may request GW Pharma’s assistance with preparing the filings for such INDs and if so requested GW Pharma will give Otsuka reasonable assistance therewith at Otsuka’s cost, such cost to be in addition to and not part of the Research Costs. For clarity, whether or not Otsuka requests GW Pharma’s assistance with preparing a filing for an IND GW Pharma shall have had the opportunity to see and comment on all drafts of such proposed filings and Otsuka shall have prepared an electronic copy of the same at its own cost and expense;

5.2.3 Otsuka shall be responsible for all other communications with the relevant Regulatory Authorities whether oral or written and whether on calls, in conferences or at meetings concerning an IND covering a Selected Drug Candidate in the case of written communication on its letterhead and in its own name signed by it and in the case of oral communication by personal representation provided that:

(a) GW Pharma has first seen and commented on drafts of all written communications or suggested scripts for oral communications, as may be reasonably practicable, and Otsuka, acting reasonably, reflects any comments of GW Pharma; and

(b) GW Pharma has the right to have at least one (1) representative present in any such calls, conferences or meetings, as may be reasonably practicable given the timing of any such call, conference or meeting and to the extent not prohibited by the relevant Regulatory Authority.

(c) Otsuka shall maintain copies of all documents submitted to and received from a Regulatory Authority relating to a Selected Drug Candidate at its own cost.

(d) Otsuka shall, within ten (10) Business Days of receipt, forward to such person at GW Pharma of whom it has been notified in writing, copies of all communications received from the Regulatory Authorities relating to a Selected Drug Candidate. Questions or further actions raised or required by a Regulatory Authority relating to a Selected Drug Candidate shall be reviewed by Otsuka and GW Pharma and any response or further action shall be discussed in advance at the JRC or relevant JRC sub-committee unless an earlier response is demanded in the circumstances in which case the Parties shall confer regarding the response in such manner as is reasonably practicable..

6. CLINICAL DEVELOPMENT OF PRODUCT CANDIDATES AND LICENCE AGREEMENTS

6.1 Selection of Product Candidates. At any time during the Research Term, the Extended Research Term or *** months from the expiration of the later thereof (or such longer period as is permitted under Section 14.1.2), as the case may be, Otsuka may chose Product Candidate(s), if any, for Clinical Development. Otsuka shall notify GW Pharma in writing of whether it is has chosen one or more Product Candidates.

6.1.1 If Otsuka notifies GW Pharma in writing within the above time period that it has chosen a Product Candidate it shall include with the notice details of the intended indication to be the subject of Clinical Development by Otsuka and

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the intended geographic market(s) for which the Product Candidate(s) will be developed and, with effect from the date of such notice the provisions of Section 6.2 shall apply; or

6.1.2 If Otsuka fails to give GW Pharma any notice with regard to a Selected Drug Candidate within the time period specified above Otsuka shall, with effect from the expiry of such time period, shall have no further rights with respect to such Selected Drug Candidate or corresponding Selected BDC or BDC.

In this Section “chosen” means that all necessary internal approvals of Otsuka have been given for the commencement of Clinical Development in relation to the relevant Product Candidate. For clarity Otsuka’s selection of Product Candidate(s) shall be at Otsuka’s sole discretion.

6.2 License. Upon notice pursuant to Section 6.1.1 by Otsuka to GW Pharma from time to time during the period permitted therefor pursuant to this Agreement, GW Pharma shall be deemed to have granted to Otsuka under Collaboration IP and GW Pharma Background IP, without the need for further action by either of the Parties, an exclusive, royalty-bearing licence to make, have made, use, offer for sale, sell, import and otherwise exploit the Product Candidate(s) referenced in such notices in the Territory in the Research Field on the terms and conditions of a standard form of licence agreement to be negotiated in good faith by the Parties within one hundred and twenty (120) days of the Effective Date or such longer period as may be agreed between the Parties, which standard form licence agreement will, among other things, embody the concepts of “Fully Burdened Costs,” “Average Minimum Price” and “Commercial Supply Price” as defined terms, which concepts were incorporated into the Sativex License Agreement (each a “ Licence Agreement ”). The identity of such Product Candidate(s) shall be deemed added to Schedule 1 of the Licence Agreement GW Pharma shall enter into any instrument or agreement reasonably requested by Otsuka to memorialize the grant of the above-described licence(s), notwithstanding that no further action of the Parties shall be required to effectuate such grants. For clarity, not withstanding the grant of a licence to Otsuka to make and have made Product Candidate(s) under this Section 6.2, Otsuka’s right to make and have made Product Candidate(s) shall only be permitted in certain circumstances when GW

Pharma cannot supply the Product Candidate in question, such circumstances will be further detailed in the Licence Agreement.

6.3 Development Plan; Commercial Supply Price; Licence Financial Terms .

6.3.1 Commencing upon notice by Otsuka to GW Pharma pursuant to Section 6.1.1 the Parties shall promptly agree upon an outline plan of the Clinical Development of the Product Candidate(s) in question for the intended indications detailed in Otsuka Section 6.1.1 notice for such Product Candidates(s). Thereafter, Otsuka shall be responsible for the preparation of a detailed Clinical Development plan and budget for each such Product Candidate and shall within the same *** day period specified in Sections 6.3.2 and 6.3.3 agree with GW Pharma the level of GW Pharma’s involvement in such Clinical Development (which shall include as a minimum manufacture of Product Candidate for clinical trials and provision of CMC data with corresponding payment of agreed costs by Otsuka to GW Pharma) the resulting development plan being referenced in and forming part of the applicable License Agreement (the “ Development Plan ”). This shall include plans for the transfer of development activity to Otsuka so that it can commence Clinical Development with minimum delay and also plans for the manufacture of quantities of the Product Candidate by GW Pharma to be used in such Clinical Development and any other activities that Otsuka may request GW Pharma to perform on Otsuka’s behalf in connection with Clinical Development. For clarity, the Parties envisage and intend that the Clinical Development of the Product Candidate will continue pending agreement of the matters specified in Sections 6.3.2 and 6.3.3 and to the extent that GW Pharma supports such Clinical Development in any way it will be reimbursed such costs of doing so as may be agreed by the Parties pursuant to the terms of the Licence Agreement, when agreed, including following the mechanism set out in Section 6.4.

6.3.2 Commencing upon notice by Otsuka to GW Pharma pursuant to Section 6.1.1, the Parties shall negotiate in good faith for a period of *** days to establish the

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Commercial Supply Price including the Average Minimum Price (each to be defined in the Licence Agreement), to be paid to GW Pharma in respect of the Product Candidate(s) referenced in such notice. It is the current expectation of the Parties that the Commercial Supply Price payable to GW Pharma for supplying Otsuka with its requirements for Products containing the Product Candidate in the Territory will be expressed as a percentage of Otsuka’s annual Net Sales of each Product in the Territory. This expectation is subject to the additional expectation that in no event will GW Pharma be expected to supply Otsuka with Products containing the Product Candidate in question for sale below the Average Minimum Price for the Product in question, which price will be expressed as GW Pharma’s Fully Burdened Cost (to be defined in the Licence Agreement) for a unit of such Product plus a percentage mark up. The Commercial Supply Price and the Average Minimum Price, upon agreement of the Parties or upon establishment pursuant to the provisions of Section 6.4, shall be deemed to be added to Schedule 2 of the Licence Agreement.

6.3.3 Commencing upon notice by Otsuka to GW Pharma pursuant to Section 6.1.1, the Parties shall negotiate in good faith for a period of *** days, concurrent with the negotiating period set forth in Section 6.3.2, to establish commercially reasonable upfront licence fees, milestone payments and royalties to be paid by Otsuka to GW Pharma in respect of the Product Candidate(s) chosen by Otsuka for Clinical Development. The amount of such milestones and the royalty rates shall take into account such relevant factors as whether the Product Candidate in question is a therapeutic, diagnostic, preventative or palliative product, the anticipated market size, market receptivity to such a product, the existence of competitive products, regulatory requirements, the availability of data regarding milestones paid and royalty rates under comparable circumstances, and other commercially relevant matters. The agreed milestone regime for the Clinical Development of such Product Candidate and the applicable royalty rate shall be deemed added to Schedule 3 of the Licence Agreement.

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6.4 Failure of Negotiations. If the Parties fail to agree upon any, or all, of the Commercial Supply Price, the Average Minimum Price, the upfront licence fee, the milestone regime and the applicable royalty rate within the times provided pursuant to Sections 6.3.2 and 6.3.3, the Parties shall continue their efforts to reach agreement on any such financial terms with respect to which they have so failed to agree through the appointment of a mediator pursuant to Section 15.3. If the Parties fail to reach agreement on such outstanding financial terms pursuant to Section 15.3, the matter of fair value and fair price shall be submitted to an investment banking firm or other appraiser agreed upon by the Parties for a final and binding determination pursuant to Section 15.4. With respect to the Parties’ failure to agree upon either or both of the Commercial Supply Price and the Average Minimum Price, the Parties shall appoint an expert in matters of pharmaceutical manufacturing and pricing to assist the investment banking firm or other appraiser in carrying out its responsibilities pursuant to Section 15.4. If the Parties are unable to agree upon and appoint such a manufacturing and pricing expert within thirty (30) days of appointment of the investment banking firm or other appraiser, such investment banking firm or other appraiser shall appoint such expert.

7. RESTRICTIONS AND OTHER RIGHTS

7.1 Restriction on Otsuka. Otsuka undertakes to GW Pharma that it will not (whether acting by itself, its Affiliates or with a Third Party collaborator) carry out any activity involving the research, development, manufacture or commercialization of a Phytocannabinoid or a Synthetic Cannabinoid other than pursuant to this Agreement during the Research Term and any Extended Research Term.

7.2 GW Pharma’s Activities Outside the Research Field. Subject to the provisions of Section 7.5, GW Pharma may conduct research, at its own expense, outside the Research Field, but shall not, whether for its own account or for a Third Party, conduct research or development activities within the Research Field, other than pursuant to or as permitted by this Agreement (including as permitted under Section 7.4) during the Research Term or the Extended Research Term. For clarity, during the term of this Agreement, GW Pharma shall be free to use all GW Pharma Background IP outside the Research Field, and shall be free to research, develop and commercialize BDCs and subsequent product candidates and products outside the Research Field as permitted under this Agreement. GW Pharma

shall have a worldwide, exclusive, royalty bearing sub-licensable licence to use Collaboration IP outside the Research Field other than that specifically relating to Selected Drug Candidates, Product Candidates and Products outside the Research Field including the research, development and commercialization of BDCs and selected BDCs and subsequent product candidates and products outside the Research Field. Any product developed by GW Pharma or its licensees in this way Covered by Collaboration IP shall be a “ GW Pharma Product ”. The foregoing rights of GW Pharma shall not be construed in derogation of the obligations of GW Pharma set forth in Section 7.5.

7.3 Otsuka’s Rights Outside the Research Field. Otsuka may approach GW Pharma to negotiate an exclusive, worldwide licence from GW Pharma on commercially reasonable terms to make, have made, use, offer for sale, sell, import and otherwise exploit Selected Drug Candidates, Product Candidates and Products outside the Research Field. It shall be in GW Pharma’s sole discretion whether it agrees to enter into negotiations with Otsuka regarding the granting of rights to Otsuka to make, have made, use, offer for sale, sell, import and otherwise exploit Selected Drug Candidates, Product Candidates and Products outside the Research Field.

7.4 GW Pharma’s Rights Inside the Research Field. Subject to the provisions of Section 7.5, following expiry of the three (3) month period after the Research Term and any Extended Research Term, GW Pharma shall be free to use all GW Pharma Background IP inside the Research Field for any purpose whatsoever and GW Pharma shall have an exclusive, worldwide, sub-licensable, royalty-bearing licence to use Collaboration IP other than that relating to any Selected Drug Candidate, Product Candidate or Product the subject of a Licence Agreement or being developed pursuant to the provisions of Section 14.1.2, for any purpose whatsoever inside the Research Field including for the research, development and commercialisation of product candidates and products inside the Research Field. Any product developed by GW Pharma or its licensees in this way Covered by Collaboration IP shall be a GW Pharma Product.

7.5 Restriction on GW Pharma. GW Pharma shall not develop or commercialize any Competitive Product either inside or outside the Research Field, whether for its own account or for a Third Party during the Research Term, the Extended Research Term, or at any time thereafter when Otsuka or any sublicensee is developing or commercializing the relevant

Selected Drug Candidate, Product Candidate or Product under the terms of a Licence Agreement or the provisions of Section 14.1.2.

7.6 Further Restriction on Otsuka . Otsuka shall not develop or commercialize a Competitive Product whether for its own account or for a Third Party at any time when GW Pharma is developing or commercializing the relevant selected drug candidate, product candidate or product pursuant to either (i) the exercise by GW Pharma of its rights outside the Research Field with respect to the selected drug candidate, product candidate or product in question under Section 7.2; provided, however, that GW Pharma has either notified the JRC of such activities pursuant to Section 3.4.6 or has otherwise promptly notified Otsuka in writing of such activities, or (ii) the exercise by GW Pharma of its rights inside the Research Field with respect to the selected drug candidate, product candidate or product in question under Section 7.4; provided, however, that GW Pharma has promptly notified Otsuka in writing of such activities. For the avoidance of doubt, this Section 7.6 shall not be construed in derogation of the Parties’ respective rights or responsibilities under Sections 7.2, 7.3, 7.4 or 7.5.

8. FUNDING OF THE RESEARCH COLLABORATION

8.1 Estimated Research Costs . The budget set forth in each Research Plan (the “ Research Budget ”) shall set out the Research Costs projected to be incurred by GW Pharma in the performance of its obligations under that Research Plan and the projected Costs of Work. The Research Budget shall estimate the Research Costs to be incurred by GW Pharma for each quarter of the Research Year covered by such Research Budget. The Research Plan for the first Research Year as attached in Schedule 1.1.77 shall include an outline Research Budget for the period from the Effective Date to 31 August 2007. GW Pharma shall submit the first invoice in respect of GW Pharma’s estimated Research Costs for such period of the first Research Year to Otsuka as soon as practicable following the Effective Date and this first invoice shall be payable within ten (10) days of its submission. By 31 August 2007, a detailed Research Budget in respect of the first Research Year shall be agreed by the JRC. GW Pharma shall submit the second invoice in respect of GW Pharma’s estimated Research Costs in respect of the balance of the first quarter and for the second quarter of the first Research Year, as set forth in the first year detailed Research Budget agreed by the JRC, to Otsuka by 31 August 2007 and this second

invoice shall be payable within ten (10) days of its submission. Otsuka shall, upon receipt of GW Pharma’s invoices (other than for this first and second period) at least thirty (30) days in advance of commencement of a quarter, pay to GW Pharma its estimated Research Costs as set forth in the Research Budget for such quarter by the 1 st day of each quarter during the Research Term and any Extended Research Term. Prior to incurring expenses in excess of a Research Budget, GW Pharma shall report to the JRC the details of such unbudgeted expenses and the need therefor. If the JRC approves an increase in the Research Budget, Otsuka shall pay such increased amount to GW Pharma upon application therefor in accordance with this Section 8.1. In the event the Parties make any change to a Research Plan, whether on application by GW Pharma or otherwise, resulting in an increase or decrease in Research Costs, the Parties shall also make corresponding changes to the corresponding Research Budget and the payments to be made to GW Pharma pursuant to this Section 8.1 shall be increased or decreased accordingly to reflect the change in the Research Budget but considering always the amount remaining in the Research Fund.

8.2 Actual Development Costs . Within ninety (90) days of the end of each Research Year, GW Pharma shall prepare a report certified by two directors, one of which shall be its Director of Finance of the actual Research Costs (for this Section “ Actual Costs ”) incurred by it in that Research Year in undertaking activities specified in each Research Plan. If such Actual Costs are greater than the estimate set out for the Research Costs in the Research Budget, as may have been amended, for that Research Year Otsuka shall make an additional payment to GW Pharma to reconcile any shortfall; provided, however, that such additional payment for which Otsuka shall be responsible shall not exceed *** percent (***%) of the Research Budget, as amended, for such Research Year. Any such payments in excess of the Research Budget shall be debited against the Research Fund. If such Actual Costs are less than the estimate set out for the Research Costs in the Research Budget for that Research Year GW Pharma shall credit Otsuka against GW Pharma’s future Research Costs for the sum of such overpayment in the next Research Year; save where there has been an overpayment in the final year of the Research term and any Extended Research Term

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in which case GW Pharma shall reimburse Otsuka for such overpayment within thirty (30) days of Otsuka receiving this report and issuing an invoice therefor. For the purpose of this Section 8.2:

8.2.1 GW Pharma will charge the time its employees are obliged to spend performing its obligations under the Research Plan as a percentage of the applicable FTE Rate and the time allocated to such FTEs in the Research Plan and corresponding Research Budget shall count towards the FTE Costs. The time GW Pharma’s employees are obliged to spend performing its obligations under the Research Plan in a Research Year shall be charged to Otsuka by expressing that time as a proportion of two hundred and twenty seven (227) working days per Research Year and multiplying it by the applicable FTE Rate for that class of GW Pharma employee; and

8.2.2 all costs in respect of research activities carried out by GW Pharma under the Research Collaboration but not set out in the Research Plan for a particular Research Year shall be borne by GW Pharma unless approved by JRC prior to performing those activities; and

8.2.3 during the term of this Agreement, GW agrees to make appropriate employees of GW Pharma available to discuss with Otsuka the methodology by which GW Pharma calculates and allocates Research Costs and Costs of Work to Otsuka. GW Pharma shall give due consideration to the reasonable suggestions of Otsuka in respect of such methodology. If a dispute should arise in respect of the methodology used by GW Pharma to calculate and/or allocate such costs, the Parties may agree to submit such dispute to resolution by a Third Party knowledgeable in such matters and acceptable to both Parties. The previous sentence notwithstanding, however, either Party may at any time submit the dispute for resolution under the provisions of Section 15 of this Agreement.

8.3 Equipment and Equipment Costs. All equipment purchased by GW Pharma with the Equipment Costs shall be owned by GW Pharma or its Affiliates.

8.4 Invoices . No payment of any type under this Section shall be due to GW Pharma without GW Pharma first having submitted an invoice therefor to Otsuka.

8.5 Cost of Work. GW Pharma shall submit to Otsuka, within thirty (30) days of the end of each quarter of each Research Year a detailed account of the Cost of Work incurred by GW Pharma in such quarter (supported by copies of invoices therefor). Otsuka shall reimburse GW Pharma such invoiced amounts within thirty (30) days of receipt of such invoice. Such amounts shall not be deducted from the Research Fund.

8.6 Research Fund. Otsuka shall submit to the JRC within thirty (30) days of the end of each quarter of each Research Year a detailed account of the balance of the Research Fund.

8.7 Settlement of Certain Other Otsuka Costs. If any costs other than Research Costs or Costs of Work are incurred by GW Pharma to a Third Party in circumstances where such costs are the responsibility of Otsuka under the express provisions of this Agreement, they shall initially be settled by GW Pharma. GW Pharma shall submit to Otsuka within thirty (30) days of the end of each month a detailed account of such costs incurred by GW Pharma in such month (supported by copies of invoices therefor). Otsuka shall reimburse GW Pharma such invoiced amounts within thirty (30) days of receipt of such invoice. For clarity, such amounts shall not be deducted from the Research Fund.

9. ROYALTY BEARING PRODUCTS

9.1 GW Pharma Products . With respect to any GW Pharma Product permitted under the Agreement to be made, used, sold or imported, under a licence to Collaboration IP and Covered by a Valid Claim thereof, GW Pharma shall pay to Otsuka a *** percent (***%) royalty on Net Sales of such GW Pharma Product by GW Pharma, its Affiliates, and their sublicensees until the expiration of the last Valid Claim on a country-by-country basis. In countries where a GW Pharma Product is permitted under the Agreement to be made, used, sold or imported under a licence to Collaboration IP where no Valid Claim exists, or following the expiration, non-appealable invalidation, abandonment or other termination of a Valid Claim in any such country, GW Pharma shall pay to Otsuka a royalty of *** percent (***%) of Net Sales in such countries, on a country-by-country basis, for *** years commencing with the first commercial sale in each such country; provided, however, with respect to GW

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Pharma Products formerly Covered by a Valid Claim, a royalty at the rate of *** percent (***%) of Net Sales shall be paid by GW Pharma only for that period of time which when added to the period of time during which royalties were paid on Net Sales under a Valid Claim pursuant to this Section 9.1 equals *** years.

9.2 Synthetic Molecule Products and Type 2 Synthetic Cannabinoid Product.

9.2.1 Otsuka will pay to GW Pharma royalties on Net Sales, by itself, its Affiliates and sublicensees, of Synthetic Molecule Products at the rate of *** percent (***%) in those countries where such Synthetic Molecule Product is Covered by a Valid Claim of Collaboration IP and at the rate of *** percent (***%) in those countries where no Valid Claim of Collaboration IP Covers such Synthetic Molecule Product. Royalties under this Section 9.2.1 shall be payable on a country by country basis for a period of *** years following launch of a Synthetic Molecule Product in that country.

9.2.2 Otsuka will pay GW Pharma royalties on Net Sales, by itself, its Affiliates and sublicensees, of Type 2 Synthetic Cannabinoid Products at the rate of *** percent (***%). Royalties under this Section 9.2.2 shall be payable on a country by country basis for a period of *** years following launch of a Type 2 Synthetic Cannabinoid Product in that country.

9.3 Royalty-Free Sales. No royalties shall be due upon the sale or other transfer of Royalty Bearing Products among the paying Party or its Affiliates or their respective sublicensees, but in such cases the royalty shall be due and calculated upon their Net Sales to the first unaffiliated Third Party in an arm’s length transaction. No royalties shall be payable on the disposition of Royalty Bearing Products in arm’s length transactions (a) without consideration (i) as samples (promotion or otherwise), or (ii) as donations (for example, to non-profit institutions for non-commercial purpose or government agencies for a non-commercial purpose); or (b) pursuant to “treatment IND”, compassionate use, or other patient care programs, solely to the extent that the consideration, if any, paid to the Party or its Affiliates or their respective sublicensees

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pursuant to any such program is limited to reimbursement of the costs of manufacturing and providing the Royalty Bearing Product. For clarity, save as set out in (a) and (b) above upon the sale or other disposal of Royalty Bearing Product other than in a bona fide arm’s length transaction exclusively for money or upon any use of Royalty Bearing Product for purposes which do not result in a disposal of that Royalty Bearing Product in consideration of sales revenue customary in the Territory (in this case disposal not including destruction of damaged, defective, or otherwise unsaleable Royalty Bearing Products), such other sale, disposal or use shall be deemed to constitute a sale at the relevant open market price in the Territory, or, if that price is not ascertainable, a reasonable price assessed on an arm’s length basis for the goods or services provided in exchange for the supply.

9.4 Reports . Each Party shall prepare and provide reports of Net Sales of Royalty Bearing Products to the other Party within sixty (60) days following the end of each calendar quarter. Each such report shall include in sufficient detail such information as may be necessary to permit confirmation of the accuracy of the royalty payments made for such quarter, together with details and an explanation of each of the deductions taken in calculating Net Sales and the reasons therefor. As an alternative to such reports, the Parties may agree to meet to discuss such matters with such frequency as they may determine.

9.5 Invoices . No payment of any type under this Section shall be due without an invoice first having been submitted to the paying Party.

10. PAYMENTS; RECORDS; AUDITS

10.1 Manner and Place of Payment . All payments of Research Costs hereunder shall be made in UK Pounds Sterling. All payments under Sections 9.1 and 9.2 shall be payable in U.S. dollars. With respect to any year (be it a calendar year or a Research Year), quarter or month, as applicable, whenever conversion from any other currency shall be required in order to calculate (i) Net Sales or (ii) to convert any Research Costs that have been incurred into a U.S. dollar value only for the purpose of accounting for the payment of the same from the Research Fund and determining the balance of the same, such conversion shall be made at a rate of exchange pertaining to the last business day of the period in respect of which such financial obligation arose or the day on which such obligation arose, as applicable, based upon the published

rates thereof as set forth in the Financial Times and appropriately calculated under IAS in the case of GW Pharma and GAAP in the case of Otsuka and will be so certified annually by each Party. All payments owed under this Agreement shall be made by wire transfer to a bank and account designated in writing by the Party entitled to receive such payment, unless otherwise specified in writing by such Party. All payments owed under this agreement will be paid within thirty (30) days of receiving an invoice therefor or such other time as expressly specified hereunder.

10.2 Taxes . All taxes incurred by GW Pharma on payments made under this Agreement, including taxes levied thereon as income to GW Pharma, shall be paid by GW Pharma.

10.3 Records and Audits . During the period when any payment is due from one Party to the other Party hereunder and for a period of three (3) years thereafter, the Parties shall keep complete and accurate records in accordance with GAAP in the case of Otsuka or IAS within case of GW Pharma pertaining to the costs related to the research and Pre-Licence Development of Research Compounds under the Research Plan (including Research Costs and Cost of Work) and the sale or other disposition of Royalty Bearing Products hereunder for the preceding three (3) years. Each Party shall have the right to cause an independent, certified public accountant and associated with an independent accounting firm reasonably acceptable to the other Party to audit such records to confirm Actual Costs, Cost of Work and/or Net Sales (in this case including an audit of each of the deductions taken in calculating Net Sales), royalties and other payments for a period covering not more than the preceding three (3) years. Such audits may be exercised during normal business hours upon reasonable prior written notice to the audited Party. The accounting firm shall enter into appropriate obligations of confidence with the audited Party to treat all information it receives during its inspection in confidence. The accounting firm shall disclose to the auditing Party only whether audited reports of costs or royalties are correct and details concerning any discrepancies, but no other information shall be disclosed to the auditing Party. Prompt adjustments shall be made by the Parties to reflect the results of such audit. The initiating Party shall bear the full cost of such audit unless such audit discloses a variance of more than five percent (5%) from the amount of Actual Costs, Cost of Work, Net Sales or other payments due to the auditing Party under this Agreement, in which event the audited Party shall bear the

full out-of-pocket cost of such audit. If any such audit reveals any underpayment or overpayment, the Parties shall promptly reconcile any such underpayment or overpayment.

10.4 VAT . All payments to GW Pharma under the terms of the Agreement are expressed to be exclusive of value added or other sales tax howsoever arising and Otsuka or any sub-licensee Affiliate of Otsuka shall pay to GW Pharma in addition to those payments all value added or other sales tax, if any, for which GW Pharma is liable to account to the applicable tax authority, as a result of the assignment of this Agreement to an Otsuka Affiliate domiciled in the European Union, in relation to any supply made or deemed to be made for value added or other sales tax purposes to this Agreement on receipt of a tax invoice or invoices from GW Pharma, subject to the right of Otsuka to dispute the same in good faith.

10.5 Interest . If a Party fails to make any payment due to the other Party on the due date for payment and the payment is not in dispute between the Parties, or the dispute has not been resolved, without prejudice to any other right or remedy available to the unpaid Party, the unpaid Party shall be entitled to charge the other Party interest (both before and after judgment) on the amount unpaid at the annual rate of LIBOR plus *** per cent (***%) calculated on a daily basis provided always that this rate of interest is permissible under the law of England and Wales until payment in full is made without prejudice to a Party’s right to receive payment on the due date.

11. CONFIDENTIALITY

11.1 Confidentiality . During the terms of this Agreement, each Party hereto will maintain in confidence all Confidential Information disclosed to it by the other Party hereto, whether pursuant to this Agreement or otherwise. Neither Party will use, disclose or grant use of such Confidential Information except as expressly authorized by, or expressly contemplated by the licences granted under, this Agreement. This Agreement contemplates disclosure to the employees, agents, contractors and consultants of each Party. In each such case the Disclosing Party shall have obtained or will obtain prior written agreement from its employees (whether in the form of a

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written condition of employment or otherwise), agents, contractors or consultants to whom disclosure is to be made to hold in confidence and not make use of such information for any purpose other than those permitted by this Agreement. Each Party will use at least the same standard of care as it uses to protect its own Confidential Information to ensure that such employees, agents, contractors or consultants do not disclose or make any unauthorized use of such Confidential Information. Each Party shall remain responsible for breaches of the confidentiality and non-use provisions of this Agreement by its employees (including the Otsuka Scientists in the case of Otsuka), agents, contractors and consultants. Each Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Confidential Information. Notwithstanding the foregoing to the contrary, a Party may disclose to its Affiliates Confidential Information received from the other Party and such Affiliates may disclose such Confidential Information on a need to know basis to their employees, agents, contractors and consultants under prior written agreements of confidentiality and non-use consistent with the terms of this Agreement; provided, however, each Party shall remain responsible for breaches of the confidentiality and non-use provisions of this Agreement by its Affiliates and their employees, agents, contractors and consultants.

11.2 Authorized Disclosure . A recipient Party may:

11.2.1 disclose Confidential Information disclosed to it hereunder to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications in accordance with this Agreement, or prosecuting or defending litigation in accordance with this Agreement;

11.2.2 disclose the Confidential Information disclosed to it hereunder: (i) to the extent such disclosure is reasonably necessary to comply with the order of a court; or (ii) to the extent such disclosure is required to comply with an applicable Law, including to the extent such disclosure is required in publicly filed financial statements or other public statements under rules governing a stock exchange (e.g., the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, UKLA or any other stock exchange on which securities issued by either Party may be listed); provided, to the extent possible bearing in mind such Law and subject to the next subsequent sentence

of this Section 11.2, such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure ten (10) Business Days in advance of the date on which the disclosure is to be made to enable the other Party to review and provide comments, unless a shorter review time is agreed. If the compliance with an applicable Law requires filing of this Agreement, the filing Party shall to the extent possible seek confidential treatment of portions of this Agreement from the relevant competent authority and shall provide the other Party with a copy of the proposed filings at least ten (10) business days prior to filing for the other Party to review any such proposed filing. If bearing in mind such Law those consultation periods are not workable the relevant Party shall use reasonable efforts to have some form of consultation with the other Party, as an absolute minimum informing the other Party of the text of any statements or disclosure as long in advance as is practicable before they are made. Each Party agrees that it will obtain its own legal advice with regard to its compliance with such Laws and will not rely on any statements made by the other Party relating to such Laws;

11.2.3 disclose Confidential Information disclosed to it hereunder to a Regulatory Authority as reasonably necessary to obtain an IND in a particular jurisdiction to the extent consistent with the licences granted under the terms of this Agreement and a Party’s obligations under the Research Collaboration;

11.2.4 disclose Confidential Information disclosed to it hereunder: (i) to its actual or potential sub-contractors; (ii) to its actual or potential investment bankers; (iii) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business; and (iv) to a bona fide potential acquirer or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such Persons must be obligated to substantially the same extent as set forth in Section 11.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement. Each Party shall remain responsible for breaches of the confidentiality and non-use provisions of this Agreement by any such Persons.

Each Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Confidential Information; and

11.2.5 disclose Confidential Information disclosed to it hereunder to its legal and other advisers for the purpose of seeking advice.

11.3 Other than the press releases pertaining to this transaction that the Parties have agreed upon and attached as Schedule 11.3 to this Agreement and save as permitted in Section 11.2.2 :

11.3.1 neither Party shall make any public announcement or statement to the public concerning the terms of this Agreement without the prior written consent of the other, which shall be neither unreasonably withheld or delayed. No such public announcements or statements shall be made without the prior review and consent of the appropriate individual designated for the purpose by the other Party;

11.3.2 neither Party shall publish or present in a scientific journal or any other scientific setting any data generated under the Research Collaboration by or for such Party with respect to a Research Compound without providing a copy of such publication or presentation to the JRC at least thirty (30) days prior to submission thereof for publication or presentation and obtaining the JRC’s prior written consent (which may not be unreasonably withheld or delayed). The JRC shall be entitled to delay the publication or presentation in the Territory for up to ninety (90) days to allow the preparation and filing of a patent application relating to any patentable invention contained in such publication or presentation.

11.4 Injunctive Relief . The Parties expressly acknowledge and agree that any breach or threatened breach of this Section 11 may cause immediate and irreparable harm to the disclosing Party that may not be adequately compensated by damages. Each Party therefore agrees that in the event of such breach or threatened breach and in addition to any remedies available at law, the disclosing Party shall have the right to obtain equitable and injunctive relief, without bond, in connection with such a breach or threatened breach.

12. INTELLECTUAL PROPERTY RIGHTS.

12.1 Ownership and Disclosure Obligations

12.1.1 Any and all GW Pharma Background IP shall as between GW Pharma and Otsuka remain vested in and be owned by GW Pharma. Commencing promptly after the Effective Date GW Pharma shall disclose to Otsuka all of the GW Pharma Background IP and copies of all Documents containing the same. Thereafter during the Research Term and any Extended Research Term, GW Pharma shall disclose to Otsuka all GW Pharma Background IP which GW Pharma Controls or to which GW Pharma acquires Control after the Effective Date and all Documents containing the same that (i) relate to the Research Compounds the subject of a Research Plan, and/or (ii) are necessary for Otsuka in performing its obligations under a Research Plan.

12.1.2 On an ongoing basis during the Research Term and any Extended Research Term, each Party shall promptly disclose to the other Party, through its representative to the JRC, any inventions conceived pursuant to the Research Collaboration and Know How forming part of Collaboration IP other than manufacturing Know How. As between the Parties Collaboration IP, whether it is invented by: (i) employees of GW Pharma solely (or jointly with a Third Party subcontractor of GW Pharma); or (ii) employees of Otsuka solely (or jointly with a Third Party subcontractor of Otsuka); or (iii) an employee of GW Pharma (or a Third Party subcontractor of GW Pharma) and an employee of Otsuka (or a Third Party subcontractor of Otsuka) jointly, will be jointly owned by GW Pharma and Otsuka and each Party retains an undivided one-half interest in and to Collaboration IP (including Joint Patent Rights, any Know How therein and Collaboration Materials). Subject to the rights and licences granted by one Party to the other under this Agreement, each Party shall not exercise its ownership rights in and to that Collaboration IP for any field, including the right to licence and sub-licence, nor shall it otherwise exploit, transfer or encumber its ownership interest, without the consent of the other Party.

12.1.3 For Collaboration IP that will be the subject of a patent application for Joint Patent Rights, the JRC will make an initial determination of inventorship prior to filing of the application therefor. Each Party will provide information and records relevant to such determination by the JRC. The JRC will apply the applicable standards for determining inventorship under US laws of inventorship.

12.2 Licences

12.2.1 GW Pharma hereby grants to Otsuka under GW Pharma Background IP and Collaboration IP, the sole right to use the same in any way whatsoever for the purpose of the Research Collaboration including to research and use Research Compounds for the purposes necessary to perform its obligations and exercise its rights under the Research Plan but excluding the right to manufacture Research Compounds or have Research Compounds manufactured on its behalf other than by GW Pharma. This right shall not be capable of sub-licence (but this does not preclude Otsuka from appointing sub-contractors under Section 3.4.3).

12.2.2 Otsuka hereby grants to GW Pharma under the Collaboration IP, the non-exclusive right to use the same in any way whatsoever for the purpose of the Research Collaboration including to research, make, have made and use Research Compounds for the purposes necessary to perform its obligations and exercise its rights under the Research Plan. This right shall not be capable of sub-licence (but this does not exclude the possibility for GW Pharma to appoint sub-contractors under Section 3.4.3).

12.3 Patent Prosecution and Maintenance

12.3.1 GW Pharma shall control, and be responsible for, filing, prosecution, and maintenance and defense of GW Pharma Patent Rights including but not limited to any interference, reissue or re-examination or opposition or revocation proceedings and GW Pharma shall pay the expenses thereof. GW Pharma and Otsuka and their nominated patent attorneys shall regularly meet and confer regarding strategies for the filing, prosecution and defense of GW Pharma Patent Rights and proposed responses to official actions. GW Pharma

shall consider in good faith and give due regard to the requests and suggestions of the other with respect to strategies for prosecuting the GW Pharma Patent Rights. GW Pharma shall keep Otsuka informed of progress with regard to the prosecution, maintenance and defense of GW Pharma Patent Rights by providing Otsuka with copies of all applications, filings, official actions, amendments and responses with respect to such prosecution promptly following such filings, submissions and responses, and within seven (7) days of receipt of such actions, notices and the like. GW Pharma shall confer with Otsuka and give Otsuka such opportunity as may be practicable in light of applicable deadlines to comment upon proposed filings, correspondence, responses and the like to be transmitted to intellectual property authorities and shall consider in good faith any comments or suggestions of Otsuka pertaining thereto and give the same due regard.

12.3.2 In the event that GW Pharma desires to abandon any GW Pharma Patent Rights, GW Pharma shall provide prior written notice to Otsuka of such intention to abandon as soon as is reasonably practicable under the circumstances, but not less than ninety (90) days prior to the date of abandonment, and Otsuka shall have the right, at its expense, to prepare, file, prosecute and maintain such GW Pharma Patent Rights. GW Pharma shall execute such documents and perform such acts as may be reasonably necessary for Otsuka to prepare, file, prosecute or maintain such GW Pharma Patent Rights. Thereafter, Otsuka shall solely own such GW Pharma Patent Rights and GW Pharma shall promptly assign its entire interest in such GW Pharma Patent Rights to Otsuka. GW Pharma shall have a non-exclusive fully paid-up irrevocable licence to practice and otherwise exploit the inventions claimed or issued in such GW Pharma Patent Rights in any way whatsoever, but not in relation to the development, making, having made, selling, offering for sale or otherwise exploiting Research Compounds, Product Candidates or Products in the Research Field in the Territory. As a condition to such licence, in the event that patents issue from such abandoned GW Patent Rights, GW Pharma shall reimburse Otsuka its out-of-pocket costs and expenses related to the prosecution and issuance of such patents and thereafter shall equally share the costs of maintenance.

12.3.3 GW Pharma shall control, and be responsible for, filing, prosecution, and maintenance and defense of the Joint Patent Rights (including but not limited to any interference, reissue or re-examination or opposition or revocation proceedings) and Otsuka shall reimburse GW Pharma its out-of-pocket costs thereof. GW Pharma and Otsuka and their respective patent attorneys shall regularly meet and confer to establish, evaluate and modify, as advisable, strategies for the filing, prosecution and defense of Joint Patent Rights and proposed responses to official actions. GW Pharma shall consider in good faith and give due regard to the requests and suggestions of Otsuka with respect to strategies for prosecuting the Joint Patent Rights and shall accept the same unless in conflict with the strategies pertaining to pursuit of the GW Pharma Patent Rights. GW Pharma shall keep Otsuka informed of its progress with regard to the prosecution, maintenance and defense of the Joint Patent Rights by providing Otsuka with copies of all applications, filings, official actions, amendments and responses with respect to such prosecution promptly following such filings, submissions and responses, and within seven (7) days of receipt of such actions, notices and the like. In satisfaction of its obligations set forth above, GW Pharma shall confer with Otsuka and give Otsuka such opportunity as may be practicable in light of applicable deadlines to comment upon proposed filings, correspondence, responses and the like to be transmitted to intellectual property authorities.

12.3.4 In the event that Otsuka no longer wishes to pay GW Pharma its out-of-pocket costs for the prosecution, maintenance and defense of any Joint Patent Rights, Otsuka shall give written notice of such intention and GW Pharma shall have the right, at its expense, to prepare, file, prosecute and maintain such Joint Patent Rights thereafter. In such a case Otsuka shall assign its entire right, title and interest in and to the Joint Patent Rights in question to GW Pharma and such Patent Rights shall cease to be Joint Patent Rights and shall also not be considered to be GW Pharma Patent Rights and GW Pharma shall be permitted to file, prosecute, maintain, enforce and defend such former Joint Patent Rights as GW Pharma in its sole discretion, sees fit.

12.4 Infringement by Third Parties.

12.4.1 Each of GW Pharma and Otsuka shall promptly notify the other in writing of (i) any alleged or threatened infringement or any challenge to the validity of any GW Pharma Patent Rights or Joint Patent Rights in the Territory, or (ii) any challenge to GW Pharma’s ownership of, or Otsuka’ right to use, the GW Pharma Patent Rights in the Territory, or (iii) any challenge to the Parties’ ownership of, or a Party’s right to use, the Joint Patent Rights in the Territory, of which they become aware. Challenges to the validity of GW Pharma Patent Rights outside of the context of an infringement action will be dealt with by GW Pharma in accordance with the provisions of Section 12.3.1. Challenges to the validity of Joint Patent Rights outside of the context of an infringement action will be dealt with by GW Pharma in accordance with the provisions of Section 12.3.3.

12.4.2 Both Parties shall use their commercially reasonable efforts in cooperating with each other to terminate any infringement without litigation.

12.4.3 GW Pharma shall have the first right, at its expense, to bring and control any action or proceeding with respect to infringement of any GW Pharma Patent Rights in the Research Field in the Territory (including any counterclaim for invalidity or unenforceability or any declaratory judgment action) by counsel of its own choice, and Otsuka shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If GW Pharma fails to bring an action or proceeding with respect to infringement of any GW Pharma Patent Rights in the Research Field in the Territory within (a) sixty (60) days following the notice of alleged infringement or (b) thirty (30) days before the time limit, if any, set forth in the appropriate Laws and regulations for the filing of such actions, whichever comes first, Otsuka shall have the right to bring and control any such action at its own expense and by counsel of its own choice and shall have the right to join GW Pharma as a co-plaintiff if GW Pharma is a necessary party, as advised by Otsuka’s counsel, at Otsuka’s cost and expense. GW Pharma shall also have the right, at its own expense, to be represented in any such action by counsel of its own choice. In the event a Party brings an infringement action regarding GW Pharma Patent Rights, the

other Party shall cooperate fully with the Party bringing such action. Neither Party shall have the right to settle any infringement litigation under this Section 12.4.3 regarding an infringement of any GW Pharma Patent Rights in the Territory in the Research Field without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. For clarity, this means that the Party that has conduct of any action in particular cannot settle any counter-claim for invalidity of a GW Pharma Patent Right without the prior consent of the other Party. GW Pharma shall consult Otsuka in advance with regard to infringement actions or proceedings outside the Research Field. GW Pharma shall consider in good faith and give due regard to any comments or suggestions of Otsuka relating thereto.

12.4.4 Otsuka shall have the first right, but not the obligation, at its expense to bring and control any action or proceedings with respect to infringement of any Joint Patent Rights in the Research Field in the Territory (including any counterclaim for invalidity or unenforceability or any declaratory judgment action) by counsel of its own choice, and GW Pharma shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If Otsuka fails to bring an action or proceeding with respect to infringement of any Joint Patent Rights in the Research Field in the Territory within (a) sixty (60) days following the notice of alleged infringement or (b) thirty (30) days before the time limit, if any, set forth in the appropriate Laws and regulations for the filing of such actions, whichever comes first, GW Pharma shall have the right to bring and control any such action at its own expense and by counsel of its own choice and shall have the right to join Otsuka as a co-plaintiff if Otsuka is a necessary party, as advised by GW Pharma’s counsel, at GW Pharma’s cost and expense. Otsuka shall also have the right, at its own expense, to be represented in any such action by counsel of its own choice. In the event a Party brings an infringement action regarding Joint Patent Rights, the other Party shall cooperate fully with the Party bringing such action. Neither Party shall have the right to settle any infringement litigation under this Section 12.4.4 regarding an infringement of any Joint Patent Rights in the Territory in the Research Field without the prior written consent of the other Party, which consent shall not be unreasonably

withheld or delayed. For clarity, this means that the Party that has conduct of any action in particular cannot settle any counter-claim for invalidity of a Joint Patent Right without the prior consent of the other Party.

12.4.5 Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery realized as a result of such litigation shall first be applied to reimbursement of the Party first bringing such litigation, then to reimbursement of a Party joining such litigation, and finally any amount remaining shall be shared between the Parties with the enforcing Party retaining *** percent (***%) thereof and the other Party retaining *** percent (***%) thereof.

12.5 Infringement of Third Party Rights . Each Party shall promptly notify the other in writing of any written allegation or claim by a Third Party that one or more activities of either of the Parties pursuant to this Agreement infringes or may infringe the intellectual property rights of such Third Party. Prior to the commencement of proceedings by any such Third Party each Party shall, in close consultation and liaison with the other, be responsible for responding to the Third Party on their own behalf.

13. REPRESENTATIONS, WARRANTIES AND ADDITIONAL COVENANTS

13.1 Mutual Representations, Warranties and Covenants. As of the Effective Date each Party hereby represents and warrants to, and covenants with, the other Party as follows:

13.1.1 Existence and Power . Such Party (i) is duly organized, validly existing and in good standing under the laws of the state or other jurisdiction in which it is organized; and (ii) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not materially adversely affect such Party’s ability to perform its obligations under this Agreement.

13.1.2 Authorization and Enforcement of Obligations . Such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder, and (ii) has taken all necessary action on its

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part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

13.1.3 No Consents . All necessary consents, approvals and authorizations of all governmental authorities and other Persons required to be obtained by such Party in connection with entering this Agreement have been obtained.

13.1.4 No Conflict . The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any law, regulation, order, tax lien or other requirement of any governmental body, court or administrative or other agency having jurisdiction over such Party and (ii) do not conflict with, or constitute a material default or require any consent under, any agreement, instrument or understanding, oral or written, to which it is a Party or by which it may be bound. Neither Party shall enter into any agreement or arrangement with any Third Party that would prevent or in any way interfere with its obligations pursuant to this Agreement.

13.1.5 Debarment. Neither it nor any researcher engaged by it, in any capacity, in the Research Collaboration has been debarred or is subject to debarment or has otherwise been disqualified or suspended from performing scientific or clinical investigations or otherwise subjected to any restrictions or sanctions by the FDA or any other governmental body or Regulatory Authority or professional body with respect to the performance of scientific or clinical investigations. Each Party agrees to inform the other in writing immediately if it or any Person who is performing services hereunder is debarred, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its or its Affiliates’ knowledge, is threatened, relating to the debarment of its or any Person performing services hereunder.

13.2 GW Pharma Representations, Warranties and Covenants . As of the Effective Date, GW Pharma represents and warrants to Otsuka as follows:

13.2.1 GW Pharma has sufficient rights and power to grant the licences to Otsuka which it purports to grant herein.

13.2.2 GW Pharma knows of no Third Party infringement of the GW Pharma Patent Rights or misappropriation of the Know How within GW Pharma Background IP.

13.2.3 GW Pharma has not received a written claim from a Third Party that the practice of the GW Pharma Background IP in the Research Field infringes or will infringe any Third Party rights.

13.2.4 There are no outstanding liens, encumbrances, licence grants or agreements, either written, oral or implied, regarding the GW Pharma Background IP which are inconsistent or in conflict with any provision of this Agreement

13.3 Disclaimer of Warranties . EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

13.4 Limitation of Liability . IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES.

14. TERM; TERMINATION

14.1 Term . This Agreement shall come into effect on the Effective Date. The Research Collaboration shall continue until the expiry of the Research Term and any Extended Research Term unless terminated earlier pursuant to Section 14.2 or 14.3 and thereafter shall expire. Upon any such expiry or termination any Licence Agreements

that have previously come into force or that may come into force in respect of any selection of a Product Candidate pursuant to Section 6.1.1 shall continue and Sections 6 (but only for so long as is necessary for Otsuka to choose Product Candidates during the three (3) month period following expiration of this Agreement and to enter into License Agreements related thereto), 7.2, 7.3, 7.4, 7.5, 7.6, 8.3, 8.4, 9, 10, 11, 12.3 to 12.5, 13.3, 13.4, and 14 to 17, as well as any other Sections referenced thereby and defined terms used therein, to the extent necessary to give such continuing Sections their intended effects, shall survive the expiry of this Agreement. Upon expiration of this Agreement, there having been a selection of a Product Candidate pursuant to Section 6.1.1 (including as provided below) by Otsuka, this Agreement shall be amended and restated in the form attached hereto as Schedule 14.1. Whether in respect of an expiration or termination, GW Pharma shall prepare a closing account of Actual Costs in line with Section 8.2 and all sums payable by one Party to the other Party hereunder for such Actual Costs from the Research Fund or otherwise due for the period up to and including expiration or termination shall be paid within thirty (30) days of receipt of an invoice for the sums due as per such closing account. The expiry of the Research Collaboration shall include Section 6 save as follows:-

14.1.1 subject to Sections 14.1.2 below, upon expiration of the Research Term and any Extended Research Term and for a period of three (3) months thereafter, Otsuka shall retain an exclusive right to designate in writing to GW Pharma from among Selected Drug Candidates the subject of the Research Plan current immediately prior to expiration of the Agreement any number of Product Candidates for Clinical Development under a Licence Agreement in accordance with the terms of Section 6.1, 6.2, 6.3 and 6.4;

14.1.2 should any then existing Selected Drug Candidate be the subject of Pre-Licence Development activities set out in the Research Plan initiated prior to the expiration of the Research Term or any Extended Research Term, as the case may be, Otsuka may continue such activities through the application of commercially reasonable efforts until completion of such activities as typically conducted to assess whether to declare a Selected Drug Candidate as a Product Candidate under this Agreement. Thereafter Otsuka shall have a period of three (3) months in which to consider the results of such Pre-Licence

Development and notify GW Pharma that it has chosen the Research Compound in question as a Product Candidate. If Otsuka so notifies GW Pharma within this three (3) month period Otsuka shall be granted a Licence Agreement subject to the terms subject to the terms of Sections 6.2, 6.3 and 6.4;

14.2 Mutual Rights of Termination . Each Party shall have the right to terminate this Agreement:

14.2.1 upon ninety (90) days’ prior written notice to the other Party upon the material breach of any provision of this Agreement by the other Party (provided that such breach is not due to the first Party’s breach) if the other Party has not cured or is not working diligently toward a cure of such breach (unless such breach is impossible to cure) within the ninety (90) day period following written notice of termination by the first Party and provided always that if the occurrence of such a material breach or breaches is disputed this Agreement shall not terminate pending a final resolution of such dispute under Section 15.1; or

14.2.2 immediately upon written notice to the other Party upon the occurrence of any Insolvency Proceeding in respect of the other Party.

14.3 Otsuka Rights of Termination of the Research Collaboration . Otsuka shall have the right to terminate the Research Collaboration, upon providing the notice to GW Pharma indicated below upon the occurrence of any of the following events:

14.3.1 upon not less than ninety (90) days’ prior written notice to be given at any time there arises, in the sole judgment of Otsuka, significant scientific, medical, regulatory or intellectual property issues pertaining to the Research Collaboration; or

14.3.2 without cause upon not less six (6) months’ prior written notice. Such notice may be given at any time after the first anniversary of the Effective Date, upon receipt of which GW Pharma shall be entitled to wind-down and discontinue activities under the Research Collaboration.

14.4 Termination for Change of Control

14.4.1 Each Party shall provide written notice to the other Party of an impending Change of Control of itself as soon as the impending Change of Control can be legally disclosed. Within fifteen (15) days of the receipt of a written notice pursuant to this Section 14.4, a senior executive of each Party shall meet to discuss the impact of any proposed Change of Control upon the Agreement and to discuss the possible nature of the relationship between the Parties following its Change of Control.

14.4.2 In the event of a Change of Control of GW Pharma or GW Pharmaceuticals plc by a Qualifying Pharmaceutical Company prior to conclusion of the Research Collaboration, Otsuka at its election shall be entitled on written notice to GW Pharma to terminate the Agreement.

14.5 Termination by Otsuka. Upon termination of this Agreement by Otsuka under Section 14.2 or 14.4 prior to conclusion of the Research Collaboration (and, for clarity, there shall be no other changes to the terms of this Agreement which will continue in force as will any Licence Agreements made hereunder pursuant to Section 6.2):

(a) the JRC and all sub-committees shall be disbanded;

(b) subject to sub-section (iii) below Otsuka shall be entitled to conduct all outstanding research and Pre-Licence Development activities under any Research Plan itself (which, for clarity, exclude manufacturing activities and Developmental CMC activities) and GW Pharma shall use reasonable efforts to transfer the same to Otsuka promptly after receipt of Otsuka’s written notice, in which case:

(i) GW Pharma shall assign to Otsuka its right, title and interest in and to each IND with respect to any Selected Drug Candidate in the name of GW Pharma and deliver promptly to Otsuka all tangible manifestations of the same. GW Pharma shall execute all necessary and appropriate letters to the MHRA and other pertinent Regulatory Authorities to ensure that ownership of

such INDs are transferred to Otsuka within ninety (90) days of Otsuka’s notice under (b) above. In the event that such a transfer is not possible, GW Pharma shall use reasonable efforts to ensure that Otsuka has the benefit of the relevant INDs and, to this end, consents to any Regulatory Authority in the Territory cross-referencing to the data and information on file with any Regulatory Authority as may be necessary to facilitate the granting of second INDs to Otsuka in the UK;

(ii) as soon as practicably possible but no later than ninety (90) days following the effective date of termination GW Pharma shall, if allowed under the relevant agreement, transfer to Otsuka the benefit and burden of any agreement made between GW Pharma and any contract research organization, clinical researcher or any other Third Party necessary for Otsuka to continue the research and Pre-Licence Development of the Research Compounds;

(iii) all licences and associated rights granted to Otsuka by GW Pharma pursuant to Section 12.2.1 shall continue in full force and effect for the shorter of: (a) for so long as it is necessary for Otsuka to complete the research and Pre-Licence Development of all Research Compounds forming part of the Research Collaboration at the date of Otsuka’s notice (i.e., until the point in time at which Otsuka is able to decide whether to designate a Research Compound as a Product Candidate); or (b) three (3) years from the date of Otsuka’s notice, but otherwise on the same terms as set forth in Sections 4, 5, 6, and 7;

(iv) Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the GW Pharma Background IP (but excluding all manufacturing know-how) and Collaboration IP in GW Pharma’s control and all Documents containing the same if not already in Otsuka’s possession and necessary for

Otsuka to complete such research and Pre-Licence Development and these will be promptly delivered to Otsuka;

(v) GW Pharma shall continue to supply Research Compounds to Otsuka. Such amounts of Research Compounds shall be supplied on the terms of Section 4.1 and Otsuka will reimburse GW Pharma its Manufacturing Costs therefor on the terms of Section 4.2; and

(vi) subject always to other provisions of this Agreement that provide for survival of certain provisions following termination, the provisions of Sections 6.1, 6.2, 6.3, 6.4, 7.3, 7.4, 7.5, 8.3, 8.4, 9, 10, 11, 12.3, to 12.5, 13.3, 13.4, and 14 to 17, as well as any other Sections referenced thereby and defined terms used therein, to the extent necessary to give such continuing Sections their intended effects, shall continue and shall apply once Otsuka has finished the work that was the subject of the Research Collaboration;

(vii) GW Pharma shall continue to supply Product Candidates and Products to Otsuka that are the subject of Licence Agreements at such time or become the subject of Licence Agreements thereafter, and

(viii) termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement prior to expiration.

14.6 Effect of Termination by GW Pharma pursuant to Section 14.2 or Otsuka pursuant to Section 14.3. If this Agreement is terminated by GW Pharma pursuant to Section 14.2.1 or 14.2.2, or the Research Collaboration is terminated by Otsuka early pursuant to Section 14.3 all of the following will apply:

14.6.1 Otsuka shall forthwith lose all of its rights and licences granted hereunder which shall terminate upon such termination, save that any Product Candidates selected by Otsuka pursuant to Section 6.1.1 shall proceed to become the subject of a Licence Agreement, and any Licence Agreements entered into prior to the effective date of termination of this Agreement shall only be terminable according to their terms, Otsuka shall cease immediately the research and Pre-Licence Development of Research Compounds. GW Pharma shall prepare a closing account of Actual Costs in line with Section 8.2 and all sums payable by Otsuka to GW Pharma hereunder from the Research Fund or otherwise for the period up to and including termination shall be paid within thirty (30) days of receipt of an invoice for the sums due as per such closing account;

14.6.2 the licence granted to GW Pharma under Section 7.2 shall continue and the licence under Section 7.4 shall come into effect and the restriction in Section 7.5 shall not apply, except in the event that a Licence Agreement has been entered into or Otsuka has selected a Product Candidate pursuant to Section 6.1.1. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Collaboration IP within Otsuka’s control and all Documents containing the same if not already in its possession and these will be promptly delivered to GW Pharma;

14.6.3 Otsuka shall assign to GW Pharma its right, title and interest in and to each IND with respect to any Selected Drug Candidate in the name of Otsuka and deliver promptly to GW Pharma all tangible manifestations of the same. Otsuka shall execute all necessary and appropriate letters to the MHRA and other pertinent Regulatory Authorities to ensure that ownership of such INDs are transferred to GW Pharma within ninety (90) days of the effective date of termination. In the event that such a transfer is not possible, Otsuka shall use reasonable efforts to ensure that GW Pharma has the benefit of the relevant INDs and, to this end, consents to any Regulatory Authority in the Territory cross-referencing to the data and information on file with any Regulatory Authority as may be necessary to facilitate the granting of second INDs to GW Pharma in the UK;

14.6.4 as soon as practicably possible but no later than ninety (90) days following the effective date of termination Otsuka shall, if allowed under the relevant agreement, transfer to GW Pharma the benefit and burden of any agreement made between Otsuka and any contract research organization, clinical researcher or any other Third Party necessary for GW Pharma to continue the research and Pre-Licence Development of the Research Compounds;

14.6.5 termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement prior to termination. Subject always to other provisions of this Agreement that provide for survival of certain provisions following expiration, the provisions of Sections 6 (but only for so long as is necessary for Otsuka to choose Product Candidates during the three (3) month period following termination of this Agreement and to enter into License Agreements related thereto) 7.6, 8.3, 9, 10, 11, 12.1, 12.3, to 12.5, 13.3, 13.4, and 14 to 17, as well as any other Sections referenced thereby and defined terms used therein, to the extent necessary to give such continuing Sections their intended effects, shall survive termination of this Agreement.

14.7 License Agreements . For the avoidance of doubt, neither expiration nor termination of this Agreement, regardless of cause, shall affect any License Agreement then in effect.

15. DISPUTE RESOLUTION

15.1 Dispute Resolution . During the term of this Agreement, except with respect to any failure of negotiation contemplated by Section 6.4, any material disputes or disagreements between Otsuka and GW Pharma arising under this Agreement and not within the authority of the JRC to resolve shall be referred to the Chief Executive Officer of Otsuka and the Managing Director of GW Pharma or their designees for good faith resolution for a period of thirty (30) days. If such officers of the Parties cannot resolve such issue, then such issue shall be resolved in accordance with Section 15.2.

15.2 Arbitration . Except with respect to any failure of negotiation contemplated by Section 6.4, any controversy arising under or related to this Agreement that is neither within the authority of the JRC to resolve nor has been resolved pursuant to Section 15.1, as applicable (excluding, in any event, any dispute relating to patent scope, validity or infringement arising under this Agreement) shall be settled by arbitration in accordance with the then existing International Arbitration Rules of the International Centre for Dispute Resolution. Upon request by either Party, arbitration will be by a panel of three (3) neutral arbitrators within thirty (30) days of such arbitration request. Each Party shall select one arbitrator and the third shall be mutually agreed upon in writing by both Parties. In any such arbitration, Otsuka and GW Pharma shall select a panel with relevant experience in the pharmaceutical industry. The arbitrators shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The arbitrators shall be authorized to award compensatory damages, but shall not be authorized (i) to award non-economic damages, such as for emotional distress, pain and suffering or loss of consortium, (ii) to award punitive damages, or (iii) to reform, modify or materially change this Agreement or any other agreements contemplated hereunder. The arbitrators also shall be authorized to grant any temporary, preliminary or permanent equitable remedy or relief they deem just and equitable and within the scope of this Agreement, as applicable, including, without limitation, an injunction or order for specific performance. Each Party shall bear its own attorney’s fees, costs and disbursements arising out of the arbitration and shall pay an equal share of the fees and costs of the arbitrators; provided, however, the arbitrators shall be authorized to determine whether a Party is the prevailing Party and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the arbitrators. Each Party shall fully perform and satisfy the arbitration award within fifteen (15) days of the service of the award. By agreeing to this binding arbitration provision, the Parties understand that they are waiving certain rights and protections which may otherwise be available if a claim between the Parties were determined by litigation in court, including, without limitation, the right to seek or obtain certain types of damages precluded by this

provision, the right to a jury trial, certain rights of appeal and a right to invoke formal rules of procedure and evidence. Judgment upon the award rendered by the panel shall be final and non-appealable and may be entered in any court having jurisdiction thereof. The Parties shall be entitled to all discovery in like manner as if the arbitration were a civil suit in the New York Supreme Court. Any arbitration under this Section 15 shall be held in New York, New York, if GW Pharma instigates proceedings and in London, England, if Otsuka initiates proceedings unless the Parties hereto mutually agree in writing to another location.

15.3 Mediation . Any mediation to decide the Commercial Supply Price, the Average Minimum Price, the milestones or royalties pursuant to Section 6.4 shall take place in New York, New York, and be conducted pursuant to the American Arbitration Association’s Commercial Mediation Rules by a mediator having significant experience with issues of the type that is the subject of the mediation. The mediator shall be mutually selected by the Parties or, if the Parties cannot agree on the selection of a mediator, the American Arbitration Association shall select the mediator. The mediation shall proceed through at least one joint mediation session or its equivalent to determine whether the Parties are capable of reaching a mediated agreement. If the mediator is satisfied that the Parties are expeditiously working to an agreement, the Parties agree to continue the mediation process for up to thirty (30) days or until earlier agreement is reached. The costs of mediation, including the fees and expenses of the mediator, shall be equally shared by the Parties, except that each Party shall bear the costs and expenses for its own counsel, experts, witnesses and preparation for, travel to, and presentations at the mediation.

15.4 Valuation . In the event that the Parties have not agreed upon the Commercial Supply Price, the Average Minimum Price, the upfront licence fee, the milestones, or the royalty, as the case may be, following mediation pursuant to Section 15.3, the fair market Commercial Supply Price, the Average Minimum Price the fair value of any upfront licence fee, the fair value of such milestones, including the events triggering payment, and the fair value of royalties shall be finally determined by an investment banking firm qualified in such matters and chosen by the Parties. Such investment banking firm shall take into account in reaching such determination the considerations set forth by the Parties in Sections 6.2 and 6.3, and the views of the expert referred to

in Section 6.4, in addition to such other factors considered relevant by such investment banking firm in making such determination. The Parties shall be entitled to make written submissions to such investment banking firm in support of their respective positions within ten (10) days of engagement of such firm. Such investment banking firm shall render its decision within ninety (90) days of engagement. The Parties shall share equally the costs of such firm.

15.5 Injunctive Relief . Notwithstanding the foregoing, either Party shall have the right to pursue an action in a court of competent jurisdiction to obtain injunctive or other equitable remedy, in order to preserve the status quo during the resolution of any dispute under this provision.

16. MISCELLANEOUS.

16.1 Insurance . Each of the Parties and their respective Affiliates and sublicensees acting under this Agreement, at their own expense, shall procure and maintain in full force and effect during the term of this Agreement and thereafter for two (2) years, comprehensive general liability insurance including, but not limited to, contractual liability coverage and product liability coverage, in each case comparable to that maintained by other similarly situated pharmaceutical companies engaged in research and Pre-Licence Development of products for therapeutic use in humans, taking into account the nature of the Research Compounds and, at a Party’s or its designee’s request, shall provide the other Party or its designee, with proof of such coverage.

16.2 Assignment . Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the other Party’s consent (a) in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party, whether by merger, sale of stock, sale of assets or otherwise, or (b) to any Affiliate. For the avoidance of doubt, Otsuka may assign its rights or obligations under this Agreement, in whole or in part, to one or more Affiliates without the consent of GW Pharma. Notwithstanding the foregoing, any assignment to an Affiliate shall not relieve the

assigning Party of its responsibilities for performance of its obligations under this Agreement. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void.

16.3 Force Majeure . Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of the Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including, without limitation, fire, floods, earthquakes, natural disasters, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, terrorism, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party. Promptly following the Effective Date, GW Pharma, with the advice and consultation of Otsuka shall commence the preparation of a disaster recovery plan regarding the supply of Research Compounds.

16.4 Governing Law . This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to its choice of law provisions.

16.5 Waiver . Except as specifically provided for herein, the waiver from time to time by either Party of any right or failure to exercise any remedy shall not operate or be construed as a continuing waiver of the same right or remedy or of any other of such Party’s rights or remedies provided under this Agreement.

16.6 Severability . In case any provision of this Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

16.7 Independent Contractors . It is expressly agreed that Otsuka and GW Pharma shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency of any kind. Neither Party shall have the authority to make any statements, representations or commitments of any kind or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

16.8 Notices . All notices and other communications provided for hereunder shall be in writing and shall be mailed by first-class, registered or certified mail, postage paid or delivered personally, by overnight delivery service or by facsimile, with confirmation of receipt, addressed as follows:

If to Otsuka:		Licensing Department

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with a copy to:		Legal Affairs Department

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If to GW Pharma:		Porton Down Science Park

		Salisbury

		Wiltshire

		SP4 0JQ

		Attention: Company Secretary

		Facsimile: +44 (0) 1980 557 111

Either Party may by like notice specify or change an address to which notices and communications shall thereafter be sent. Notices sent by facsimile shall be effective upon confirmation of receipt, notices sent by mail or overnight delivery service shall be effective upon receipt, and notices given personally shall be effective when delivered.

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16.9 No Implied Licence. Except as expressly provided herein, no Party hereto shall be deemed by this Agreement to have been granted any licence or other rights to patent rights existing as of the date hereof or know-how relating to compounds, formulations or processes which are owned, licensed or controlled by another Party.

16.10 Entire Agreement; Amendment . This Agreement and its Schedules set forth the only agreements and understandings between the Parties hereto with respect to the subject matter hereof and thereof and supersede and terminate all prior agreements and understandings between the Parties with respect to the subject matter hereof and thereof. There are no other agreements or understandings with respect to the subject matter hereof, either oral or written, between the Parties. Except as expressly set forth in this Agreement, no subsequent amendment, modification or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.

16.11 Headings . The captions contained in this Agreement are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Articles hereof.

16.12 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

17. GUARANTEE BY GW PHARMACEUTICALS PLC

17.1 GW Pharmaceuticals plc is party to this Agreement solely for the purpose of the guarantee set out in this Section 17 and has no other rights or obligations hereunder.

17.2 GW Pharmaceuticals plc hereby unconditionally and irrevocably guarantees to Otsuka the performance of all the financial obligations of GW Pharma under this Agreement, including the due and prompt payment by GW Pharma of any amounts payable under this Agreement and any damages or other financial compensation for breach of this Agreement by GW Pharma or otherwise connected with GW Pharma’s activities under this Agreement. In case of the failure of GW Pharma to promptly pay any amounts or to make whole Otsuka for any of its obligations under this Agreement, GW Pharmaceuticals plc hereby agrees to cause the payment of such amounts to be

made promptly when and as such amounts become due and payable and as if such amounts were paid by GW Pharma.

17.3 GW Pharmaceuticals plc hereby unconditionally and irrevocably guarantees to Otsuka the performance of the obligations of GW Pharma pursuant to Section 14 hereof.

In Witness Whereof , the Parties have executed this Research Collaboration and Licence Agreement.

GW PHARMA LTD		OTSUKA PHARMACEUTICAL CO., LTD.

By:	/s/ Geoffrey Guy	By:	/s/ Tatsuo Higuchi

Name:	Geoffrey Guy	Name:	Tatsuo Higuchi

Title:	Executive Chairman	Title:	President and Representative Director

By:	/s/ Justin Gover	By:	/s/ Kuniaki Natsume

Name:	Justin Gover	Name:	Kuniaki Natsume

Title:	Managing Director	Title:	Senior Operating Officer Director, Pharmaceutical Research



GW PHARMACEUTICALS PLC

By:	/s/ Geoffrey Guy

Name:	Geoffrey Guy

Title:	Executive Chairman

By:	/s/ Justin Gover

Name:	Justin Gover

Title:	Managing Director

SCHEDULE 1.1.77

PART I

RESEARCH PLAN FOR FIRST RESEARCH YEAR

Follows

CONFIDENTIAL		Collaboration Agreement Version
GW / Otsuka Research Plan		5 July 2007

RESEARCH COLLABORATION

GW PHARMA LTD AND OTSUKA

PHARMACEUTICAL CO., LTD/

RESEARCH PLAN

Collaboration Agreement

Date: 5 July 2007

Authors: ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

TABLE OF CONTENTS

1	INTRODUCTION	3

2	AIM OF THE DOCUMENT	4

3	GENERAL DESCRIPTION OF FUNCTIONS	8

4	THE APPROACH TO PHARMACOLOGY	8

4.1	CATEGORY 1. PHARMACOLOGY	8

	4.1. 1 The Standard Battery), of Category 1 Pharmacology	10

4.2	CATEGORY 2 PHARMACOLOGY	10

4.3	CATEGORY 3 PHARMACOLOGY	10

5	CANDIDATES FOR SELECTION	12

5.1	AVAILABLE CANNABINOIDS	12

5.2	INDIVIDUAL BOTANICAL DRUG CANDIDATES (BDCS) AVAILABLE FOR SELECTION	12

5.3	BLENDS OF INDIVIDUAL BOTANICAL DRUG CANDIDATES (BDCS) AVAILABLE FOR SELECTION	12

5.4	COMBINATIONS WITH OTHER NON-BDC PRODUCTS	13

6	THERAPEUTIC AREAS OF INTEREST	14

7	IN VITRO MODELS TO BE USED	14

8	IN VIVO MODELS TO BE USED	16

9	SITES OF RESEARCH	18

10	PROGRAMME COSTS	19

11	PROGRAMME DOCUMENTATION	19

12	TIMESCALE FOR RESEARCH ACTIVITIES	20

1. Introduction

As a consequence of the maturity and excellence of our plant breeding programme, GW has an increasing ability to produce cannabis plants which reliably yield a ‘minor’ cannabinoid as the predominant cannabinoid. Furthermore, our ability to manipulate the extraction conditions within different extraction methodologies allows for the production of uniform and enriched plant extracts. This in turn permits the establishment of a proprietary position regarding each of the various plant extracts selected for development. Finally, and to date, the ‘combining’ of different plant extracts in order to ensure a finished product of uniform quality has been seen by regulatory agencies as an acceptable manufacturing technique. The Research Collaboration with Otsuka permits an expansion of the cannabinoid research programme and Cannabinoid Research Institute (CRI).

The clinical development of GWs lead product, Sativex was initially based primarily on clinical observation of the ‘anecdotal use’ of cannabis, rather than on an understanding of the pharmacology of the principal cannabinoids present in the plant. This information base does not exist with the majority of the minor cannabinoids. The expansion of information and knowledge regarding the cannabinoid system as it exists in mammals and other animals has lead to a conviction that compounds with activity in and on the endocannabinoid system may have substantial and to date unrealised therapeutic potential. We therefore have a need to define a research programme which allows for an understanding of the pure and applied pharmacology of these minor cannabinoids alone as pure compounds and as plant extracts. This will allow for their further clinical development to be tailored to their pharmacology.

Such further development is seen within the framework of this Research Plan as being within the therapeutic areas of neuropsychotherapeutics and oncology. Within neuropsychotherapeutics, the plan is primarily addressed towards *** but also towards ***. Furthermore, within the field of ***, this Research Plan will explore the *** properties of *** combinations. Within the area of ***, the *** and *** potential of cannabinoids will also be explored with a view to identifying useful *** effects.

This approach may also lead to the development of structure activity relationships which may further illuminate our understanding of the endocannabinoid system and allow for the development of *** compounds for plant cannabinoids, including ***.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

2. Aim of the Document

The objective of this document is to define the initial approach that the Research Collaboration will take to defining the pure and applied pharmacology of Phytocannabinoids, both as plant extracts, and as pure compounds, and to identify specific objectives for the first year of the plan, and more general objectives thereafter.

The primary therapeutic targets for the early programme are the areas of *** disorder) and ***. The programme will aim ultimately also to identify Botanical Drug Candidates (BDCs) in the field of *** and for use in *** combinations.

The approach to costs associated with this Research Plan are discussed in Section 10 of this document, Section 8 of the Agreement and in the Research Budget.

Objectives for first Research Year

The following objectives are proposed for the first Research Year of the Research Collaboration:

Pharmacology

1. Gain agreement of the GW/Otsuka Joint Research Committee (JRC) on the format and content of the Research Plan, and for the JRC to approve the Research Plan.

2. Agree the *** Selected BDCs to be evaluated in Category *** Pharmacology and in ***

a) Category *** Pharmacology

· All *** Selected BDCs to be in Category *** Pharmacology in the first Research Year

b) Category *** Pharmacology

· All *** Selected BDCs to be in Category *** Pharmacology in the first Research Year

c) Category *** Pharmacology

· At least *** Selected BDCs to be in Category *** Pharmacology in the first Research Year

3. Agree the *** models in which to evaluate the *** Selected BDCs

· JRC to agree the hierarchy of the most appropriate *** models to be used in each therapeutic area (minimum of 1 or 2 models per area).

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

· At least *** compounds to have started *** in at least *** of the selected models

4. Populate the ***section of the Research Plan by agreeing the approach to and timing of ***

Pharmaceutical/Analytical

5. JRC to agree the differentiation criteria for new BDCs

· A combination of ***, or a *** may be selected for evaluation in the agreed models. ***

e.g. a *** ratio of *** will be considered to be a different product to ***

6. To produce competent dose forms for Initial Pharmacological Evaluation of the *** Selected BDCs to be evaluated in ***, including ***

7. To develop and validate the bioanalytical assays required to support the *** of the first Research Year of execution of the Research Plan.

8. JRC to prioritise order of evaluation of Selected BDCs based on their availability from GW Analytical Department.

9. To *** the Selected BDCs to be evaluated in *** and ***. The target for characterisation prior to first administration to man studies will be at least ***.

10. To purify and supply the corresponding pure principal. Phytocannabinoids present in the *** Selected BDCs to be evaluated in ***, and in ***

11. To complete *** studies on the *** Selected BDCs to be evaluated in *** and ***.

12. Prepare *** for each of the ***Selected BDCs

Pre-Clinical Studies (Toxicology)

13. To perform *** of the *** Selected BDCs to be evaluated in *** and ***, once the *** of such materials allows such evaluation.

14. To initiate a standard *** battery of tests on the *** Selected BDCs to be evaluated in *** and ***.

15. JRC to agree the relevant *** battery of tests to be performed. It is proposed that the following are performed as a minimum:

· ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

16. To initiate a standard *** battery of tests in *** on the *** Selected BDCs to be evaluated in *** and ***. It is proposed that the following are performed as a minimum:

· ***

Method Development & Extraction

17. To initiate a programme of work to develop and improve methods of generation and extraction of the *** Selected BDCs to be evaluated in *** and ***. The three methods to be explored initially shall be ***.

Intellectual Property Rights (IPR)

18. JRC to review the status of the IPR generated under the Research Plan at each JRC Meeting.

Early Clinical Evaluation Studies (ECES)

19. Gain agreement of the JRC on the *** aims. It may be proposed that the aim is to have *** each calendar year, following the first Research Year

20. To initiate a Proof of Principle (POP) *** (using a *** Selected Drug Candidate)

21. Agree clinical study protocol for a POP *** (using a *** Selected Drug Candidate)

Scientific Expert Advisory Panel

The following is to be agreed by the JRC

22. Membership, format and content of the Scientific Advisory Board

Programme Documentation

The following documentation is to be agreed by the JRC

23. Format and content of the Discovery Research Plan

24. Format and content of the BDC Data Package

25. Format and content of the Individual Research Study Reports on work performed by scientists / individual contractors

26. Format and content of the Product Evaluation Report (to be supplied at time of selection of a Selected Drug Candidate)

27. Format and content of the Programme Intelligence (competitor activity) to be provided at each JRC Meeting

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Objectives for second Research Year

The following objectives are proposed to be included for the second Research Year:

Pharmacology

28. JRC to agree the ratios of various Selected BDCs to be evaluated in *** and *** in the second Research Year.

a) ***

· At least ***to be in appropriate *** in the second Research Year

· *** to be in appropriate *** in Year 2

***

29. Identify *** of each Selected BDC and prepare ***

30. Initiate *** of the *** of each of the Selected BDCs

31. Identify which Selected BDCs should go into extended ***, according to the *** agreed as part of the first Research Year objectives

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

3. General Description of Functions

The procedure (in general terms) and disciplines involved in this initiative are as follows:

a) *** (where appropriate) and extraction of plant extracts, and preparation of *** and of ***

i) The analytical group within the GW Technical Department at ***, within a dedicated early development team.

b) Analytical services

i) *** of extracts and quality control over the preparation of Selected BDCs are managed at ***, with external agreements where appropriate

ii) Identification of *** within early formulations.

c) Formulation services

i) Preparation of appropriate ***, including *** of drug substance, which allow for subsequent *** — done at *** in discussion with *** regarding *** and ***

d) Pharmacology

Each of the Selected BDCs will be undergo the following Categories for pharmacological evaluation:

i) *** is defined as execution of the agreed first level of ***.

ii) *** is defined as execution of the agreed second level of ***, using a commercially available ***

iii) *** may be advanced *** or *** exploration of the *** of the Selected BDCs; for example, *** and so on.

At the discretion of the JRC, *** may be undertaken either in parallel or in a sequential manner. This will be decided on a case-by-case basis.

If the JRC determines that certain *** are to be conducted in a sequential manner, then following the completion of each of these Categories, there is a formal evaluation of the suitability of the candidate for progression to the next Category.

4. The Approach to Pharmacology

4.1 ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

The first level of *** will use a *** of tests which will address the question of whether the extract has interesting *** within the ***. Responsibility for its execution will rest with *** as *** for GW and with ***, as described below.

System	*******	*******
***	X
***	X
***	X
***	X
***		X
***		X
***		X

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

4.1.1 The Standard ***

4.1.1.1 Materials to be used

In all cases, the materials to be tested should be the following

1. The Selected BDC, as close as possible to that intended for further development

2. The pure *** of principal interest in the Selected BDC

3. Positive and negative controls, as deemed appropriate.

As agreed, *** of interest may also be tested in the systems identified above to explore ***, between ***.

As a *** becomes available, this extract may also be part of the standard ***.

4.2 ***

In general *** will be done in parallel with *** investigation. If it is agreed that the *** studies are to be conducted in series, then once the results of *** are documented and the implications discussed, the Selected BDC and/or compound will enter ***.

*** comprises the following:

***.

A standard battery of *** and *** etc will be identified, and the affinity and activity of the preferred Selected BDC will be explored by contract with a preferred provider (to be identified) of such arrays.

4.3 ***

*** will be compound specific, and is likely to depend on the results of the information already generated on the compound, or by the results from ***will in general be seen as studies which may illuminate the mechanism of action, and allow for better targeting of human populations in subsequent clinical development. If it is agreed that the *** studies are to be conducted in series, then once the results of *** are documented and the implications discussed, or as agreed within the JRC, the Selected BDC and/or compound will enter ***.

*** may comprise the following:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

An agreed and custom made range of in vitro and in vivo assessments will be designed, in order to explore the *** of the Selected BDC ***.

Otsuka scientists may be responsible for the performance on especially *** to determine the potential of Selected BDCs for targeted indications. The sites and people responsible for this type of *** will be managed by agreement.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

5. Candidates for Selection

5.1 Available BDCs

The following BDCs containing, the principal Phytocannabinoids can be made available for selection at the present time:

1) ***

2) ***

3) ***

4) ***

5) ***

6) ***

7) ***

8) ***

9) ***

10) ***

11) ***

12) ***

13) ***

14) ***

5.2 Individual Botanical Drug Candidates (BDCs) Available for Selection

Of these BDCs, the following *** are proposed as the Selected BDCS as the focus for the first wave of investigation:

1) ***

2) ***

3) ***

4) ***

5) ***

6) ***

Work on these proposed Selected BDCs is expected to start within the first quarter of the first Research Year.

5.3 ***

Any *** may be evaluated in the second wave of investigation

For example:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

5.4 Combinations with Other Non-BDC Products

Any combination of the Selected BDCS with *** may be evaluated in the second wave of investigation.

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

6. Therapeutic Areas of Interest

There are a number of potential areas of therapeutic interest. These are as follows and are divided into 3 groups:

Group l

1) ***

2) ***

3) ***

4) ***

5) ***

6) ***

Group 2

7) ***

8) ***

9) ***

10) ***

11) ***

Group 3

12) ***

7. In vitro models to be Used

a) ***

No in vitro model is available for evaluation.

b) ***

No in vitro model is available for evaluation.

c) ***

No in vitro model is available for evaluation.

d) ***

No in vitro model is available for evaluation.

e) ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

The *** SBDCs will be evaluated in ***

8. *** models to be Used

The following *** models will be used for the evaluation of the 6 SBDCs. In each case the 2 preferred models (in bold) will be presented in order of priority

Priority	Indication	Animal Model
1	*******	1) ***
		2) ***
		3) ***
		4) ***
		5) ***
		6) ***
		7) ***
		8) ***
2	*******	1) ***
		2) ***
		3) ***
		4) ***
3	*******	1) ***
	*******	2) ***
		3) ***
		4) ***
		5) ***
4	*******	1) *******
		2) *******
		3) ***
		4) ***
		5) ***
		6) ***
		7) ***
		8) ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

5	*******	1) *******
		2) ***
		3) ***
		4) ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

9. Sites of Research and Responsibilities

Research Site	Responsible Personnel/Party	Activity
*** University	***	***
	***
	***
	***
***	***	***
CRO	TBD	***
	***
	***
***	Otsuka Scientists plus Otsuka hosts at ***	***
***	Otsuka Scientists plus Otsuka hosts at ***	***
		***
		***
***	Otsuka Scientists plus Otsuka hosts at ***	***
		***
		***
***	***	***
	***	***
	***	***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

10. Programme Costs

The first year Research Budget shall be reviewed and agreed by the JRC by 31 August 2007. As provided for under the Research Collaboration agreement, costs in addition to those in the Research Budget, and not to be drawn from the Research Fund, include, but are not limited to, Cost of Work, costs associated with work to be performed by Otsuka (including the Otsuka Scientists, Pre-Clinical Studies, and Early Clinical Evaluation Studies outside the UK), out-of-pocket patent costs, and GW regulatory assistance services. It is intended that these additional costs should also be quantified and agreed by the JRC during the first quarter of the first Research Year.

11. Programme Documentation

The following documentation will be provided:

Ongoing

1. Final Research Plan

2. Data Package for each BDC described above

At Study Completion

3. Individual Research Study Reports on work performed by scientists / individual contractors

At the time of Drug Candidate Selection

4. Product Evaluation Report (to be supplied at time of Selection of Drug Candidate)

At Each JRC Meeting

5. Final Research Plan

6. BDC Data Package on each potential new candidates for selection as Selected Botanical Drug Candidate for IPE

7. Individual Research Study Reports on new work reported by scientists / individual contractors

8. Product Evaluation Report (if applicable)

9. Any new Programme Intelligence (competitor activity)

10. Investigator Brochure for any Early Clinical Evaluation Studies to be undertaken as part of the Research Collaboration.

A case-by-case ad-hoc review of data may be performed at any of the JRC meetings, if agreed by all Parties.

12. Timescale for Research Activities

Requires Further Discussion by the Parties

SCHEDULE 1.1.77 (Continued)

PART II

RESEARCH BUDGET

Follows

Otsuka / GW Pharmaceuticals

Joint Research Collaboration and Licence Agreement - July and August 2007
Outline Research Fund Budget (2 Months)

Outline of estimated costs
and allocations based on

Jul-07

Aug-07

Total

Salary

% Alloc.

% Uplift

GROWING

FTE Cost

(i)

Gross Salary

***

Total Salaries (Basis of Allocation)

***

Employment Costs (NI & Pension)

***

Employment Benefits (BUPA, LA, Bonus)

***

Travel and Subsistence Costs

***

Other employment costs (Training, Recruitment etc)

***

Total Employee Costs

***

(ii)

Allocable Research Overhead

Occupancy Costs

***

Light, Power and Energy

***

Maintenance and Calibration Costs

***

Other Allocated costs (IT & Research Admin etc)

***

Total Allocable Research Overhead

***

(iii)

General Consumables

***

Total General Consumables

***

Total FTE Costs

***

Total FTE % Uplift on Gross Salary

***

Equipment Costs

Depreciation On Equipment

Total Equipment Costs

***

3 rd Party Costs

Total 3 rd Party Costs

Total Growing Costs

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Joint Research Collaboration and Licence Agreement - July and August 2007
Outline Research Fund Budget (2 Months)

Outline of estimated costs
and allocations based on

Jul-07

Aug-07

Total

Salary

% Alloc.

% Uplift

EXTRACTION / PRODUCTION

(i)

FTE Cost

Gross Salary

***

Total Salaries (Basis of Allocation)

***

Employment Costs (NI & Pension)

***

Employment Benefits (BUPA, LA, Bonus)

***

Travel and Subsistence Costs

***

Other employment costs (Training, Recruitment etc)

***

Total Employee Costs

***

(ii)

Allocable Research Overhead

Occupancy Costs

***

Light, Power and Energy

***

Maintenance and Calibration Costs

***

Other Allocated Costs (IT & Research Admin etc)

***

Total Allocable Research Overhead

***

(iii)

General Consumables

General and Lab Consumables

***

Total General Consumables

***

Total FTE Costs

***

Total FTE % Uplift on Gross Salary

***

Equipment Costs

Depreciation On Equipment

***

Total Equipment Costs

***

3 rd Party Costs

Consultancy Fees - ***

Consultants - ***

Total 3 rd Party Costs

Total Extraction Costs

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Joint Research Collaboration and Licence Agreement - July and August 2007
Outline Research Fund Budget (2 Months)

Outline of estimated costs
and allocations based on

Salary

%
Alloc.

% Uplift

Jul-07
£

Aug-07
£

Total
£

PAR&D

FTE Cost

(i)

Gross Salary

***

Total Salaries (Basis of Allocation)

***

Employment Costs (NI & Pension)

***

Employment Benefits (BUPA, LA, Bonus)

***

Other employment costs (Training, Recruitment etc)

***

Total Employee Costs

***

(ii)

Allocable Research Overhead

Occupancy Costs

***

Light, Power and Energy

***

Maintenance and Calibration Costs

***

Other Allocated Costs (IT & Research Admin etc)

***

Total Allocable Research Overhead

***

(iii)

General Consumables

General and Lab Consumables

***

Total General Consumables

***

Total FTE Costs

***

Total FTE % Uplift on Gross Salary

***

Equipment Costs

Depreciation On Equipment

***

Cost of New Equipment over £2.5k

***

Other (***)

Total Equipment Costs

***

3 rd Party Costs

***

Total 3 rd Party Costs

Total PAR&D Costs

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Joint Research Collaboration and Licence Agreement — July and August 2007

Outline Research Fund Budget (2 Months)

Outline of estimated costs
and allocations based on

Salary

%
Alloc.

% Uplift

Jul-07
£

Aug-07
£

Total
£

PHARMACOLOGY

FTE Cost

(i)

Gross Salary

***

Total Salaries (Basis of Allocation)

***

Employment Costs (NI & Pension)

***

Employment Benefits (BUPA, LA, Bonus)

***

Travel and Subsistence Costs

***

Other employment costs (Training, Recruitment etc)

***

Total Employee Costs

***

(ii)

Allocable Research Overhead

Occupancy Costs

***

Light, Power and Energy

***

Maintenance and Calibration Costs

***

Other Allocated Costs (IT & Research Admin etc)

***

Total Allocable Research Overhead

***

(iii)

General Consumables

***

Total General Consumables

***

Total FTE Costs

***

Total FTE % Uplift on Gross Salary

***

Equipment Costs

Depreciation On Equipment

***

Total Equipment Costs

***

3 rd Party Costs

***

Consultant / Research Centres

***

Other:

***

Total 3 rd Party Costs

***

Total Pharmacology Costs

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Joint Research Collaboration and Licence Agreement — July and August 2007

Outline Research Fund Budget (2 Months)

Outline of estimated costs
and allocations based on

Salary

%
Alloc.

%
Uplift

Jul-07
£

Aug-07
£

Total
£

EXECUTIVE TEAM & SUPPORT

FTE Cost

(i)

Gross Salary

***

Total Salaries (Basis of Allocation)

***

Employment Costs (NI & Pension)

***

Employment Benefits (BUPA, LA Bonus)

***

Travel and Subsistence Costs

***

Other employment costs (Training, Recruitment etc)

***

Total Employee Costs

***

(ii)

Allocable Research Overhead

Occupancy Costs

***

Light, Power and Energy

***

Maintenance and Calibration Costs

***

Other Allocated Costs (IT & Research Admin etc)

***

Total Allocable Research Overhead

***

(iii)

General Consumables

General and Lab Consumables

***

Total General Consumables

***

Total FTE Costs

***

Total FTE % Uplift on Gross Salary

***

Equipment Costs

Depreciation On Equipment

***

Total Equipment Costs

***

3 rd Party Costs

Total 3rd Party Costs

Total Executive Team and Support Costs

***

MANUFACTURING COSTS

Third Party Costs

SCIENTIFIC ADVISORY BOARD

Board costs

Grand Total - Outline Research Fund

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

SCHEDULE 1.1.77 (Continued)

PART III

COSTS FALLING OUTSIDE RESEARCH BUDGET

Follows

Otsuka / GW Pharmaceuticals

Joint Research Collaboration and Licence Agreement

Otsuka Costs - Outside of the Research Fund

Costs incurred under clause 3.3.3 (costs associated with performance of activities by Otsuka Scientists and allocated to Otsuka).

Pre-clinical studies (clause 3.2.3.)

GW Regulatory services (clause 5.2.2.)

Out of pocket patent costs (clause 12.3.3.)

Otsuka / GW Pharmaceuticals

Joint Research Collaboration and Licence Agreement - July and August 2007

Cost of Work

	Jul-07 £	Aug-07 £	Total £
*** (Cost of Work):
***	***	***	***
***	***	***	***
***	***	***	***
***	***	***	***
***	***	***	***
***	0	0	0
			0
*** (Cost of Work)	0	***	***

Assumes signature of *** agreement 1 August 2007 and arrival of Japanese Scientists on 1 September 2007.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

SCHEDULE 11.3

AGREED FORM PRESS RELEASE

Follows

GW and Otsuka Enter Into Global Cannabinoid Research Collaboration

London, UK; Tokyo, Japan; 9 July 2007: GW Pharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce that they have signed a global cannabinoid research collaboration in the field of Central Nervous System (CNS) and oncology in order to research, develop and commercialize a range of candidate cannabinoid products.

The research collaboration agreement follows the signature in February 2007 of an exclusive license and development agreement between GW and Otsuka to develop and market Sativex, GW’s lead product, in the United States.

The cannabinoid research collaboration has an initial term of three years, during which Otsuka will make available a research fund of $9 million, which may be increased from time to time by Otsuka, to cover research activities carried out by GW and its scientific collaborators under this agreement.

The GW-Otsuka collaboration research team, which incorporates senior scientists from both companies, will evaluate a range of GW cannabinoids as drug candidates within the field of CNS and oncology, with a view to selecting the most promising candidates for full clinical development, regulatory approval and global commercialization. Products selected for full development will be the subject of a license from GW. Under the terms of each product license, Otsuka will fund the global development and commercialization of such products, and GW will receive license fees, milestone payments and a long term commercial supply price and royalty. The financial terms of each license are to be agreed at the time of selection of each product for global development.

Dr Geoffrey Guy, GW’s Chairman, said, “Otsuka is a world leader in the field of CNS and we are delighted to be working with such a prestigious company to enhance and develop our product pipeline. The relationship between GW and Otsuka commenced earlier this year with the signature of the Sativex US license agreement, and this new research collaboration will serve to enhance further the close relationship between our two companies.

“Over the last few years, GW has been undertaking a primary cannabinoid research programme addressing a range of therapeutic areas under the direction of Professor Roger Pertwee and in collaboration with a number of other world leading cannabinoid scientists. This collaboration with Otsuka will enable GW to accelerate and expand this programme in order to develop and commercialise novel cannabinoid medicines in the exciting areas of CNS and oncology.”

Mr. Tetsuo Higuchi, President of Otsuka Pharmaceutical Co., Ltd. said, “Otsuka strives to contribute to the health of people around the world through the creation of innovative products in an effort to address unmet medical needs. We are delighted to be embarking on this great opportunity with GW Pharmaceuticals to further investigate cannabinoids, which are considered to be a significant potential source of new medicines in the field of CNS and oncology. At the same time, we anticipate that our further contribution to global well being will be significant as a result of this research collaboration.”

Enquiries:

For GW:
	GW Pharmaceuticals plc Dr Geoffrey Guy, Chairman Justin Gover, Managing Director Mark Rogerson, Press and PR	Today: +44 20 7831 3113 Thereafter: + 44 1980 557000 Tel: + 44 7885 638810

	Financial Dynamics David Yates, Ben Atwell
		Tel: +44 20 7831 3113
For Otsuka:
	Hideki Shirai	Tel: +81 3 6717 1400 siraih©otsuka.jp

Notes to Editors

About Cannabinoids

The cannabinoid (CB) receptor system is a complex and far-reaching system which has only started to become understood in the last decade or so. To date, CB 1 and CB 2 receptors have been identified and cloned. Initially, the chemicals which affect these receptors (“cannabinoids”) were identified only within the cannabis plant, but extensive scientific investigation has now elaborated a series of endogenous chemicals which maintain this `endocannabinoid system’. These endogenous cannabinoids are produced in human tissues, exert their actions within those tissues and are then destroyed locally. This allows the system to function in a fine-tuning, modulatory role, and abnormalities of the endocannabinoid system have now been found in several important diseases. Originally, it was believed that these receptors acted largely within the brain, but it is becoming increasingly clear that they are present at many different sites, in many different body systems.

The importance of the integrity of this system of receptors in maintaining several critical areas of mental and physical well-being is becoming clearer because of the type of research that GW and its collaborators are performing. Equally, this research work has identified several important disease areas where the administration of cannabinoids as medicines may lead to desirable therapeutic consequences. Cannabinoid modulators are showing promise in chronic painful conditions, in movement disorders, and in disorders of cell proliferation such as cancer. Furthermore, the role of cannabinoids in the brain may offer therapeutic promise in disorders of behaviour and mood. This is an area of active scientific discovery and therapeutic research which may deliver a range of new treatments to meet unmet medical needs.

About Sativex US License Agreement

On February 14 2007, GW and Otsuka entered into an exclusive license agreement to develop and market Sativex, GW’s lead product, in the US.

In 2006, the Food & Drug Administration (FDA) permitted Sativex to enter directly into Phase III clinical trials in the US for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications. GW and Otsuka currently plan for the first US pivotal efficacy clinical trial to be a Phase II/III cancer pain dose ranging study, to commence in the near future.

About Otsuka Pharmaceutical Co., Ltd

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka - people creating new products for better health worldwide.’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

The Otsuka Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 17 countries and regions worldwide. Otsuka and its consolidated earned US$7.2 billion in annual revenues in fiscal 2006.

Focusing on the central nervous system, the circulatory, respiratory, and digestive systems, ophthalmology and dermatology, Otsuka’s pharmaceutical product business engages in the research and development, manufacture and sale of pharmaceuticals, aiming to maximize the assets of a global network to address unmet medical meets. For additional information, visit www.otsuka-global.com.

About GW

developed an extensive international network of the most prominent scientists in the field. For further information, please visit www.gwpharrn.com

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’s products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex and other products by consumer and medical professionals.

Exhibit 10.17

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated 14 March 2008

GW PHARMA LTD

and

OTSUKA PHARMACEUTICAL CO., LTD

AMENDMENT NO.1 TO RESEARCH COLLABORATION AND LICENCE AGREEMENT DATED JULY 9, 2007

Execution Copy

THIS AMENDMENT AGREEMENT is made the 14 th day of March 2008 (“ Amendment No.1 ”)

BETWEEN:

(2) OTSUKA PHARMACEUTICAL CO., LTD. , a Japan corporation, with its registered office at 2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (“ Otsuka ”).

WHEREAS:

(A) On July 9, 2007 GW Pharma and Otsuka entered into a research collaboration and licence agreement (the “ Research Agreement ”).

(B) The Parties (as defined in the Research Agreement), acting though the medium of the JRC (as defined in the Research Agreement), have agreed that the Otsuka Scientists (as defined in the Research Agreement) should perform certain Initial Pharmacological Evaluation Studies (as defined in the Research Agreement) at University of Aberdeen using certain Selected BDCs (as defined in the Research Agreement) in combination with *** (the “ Compound ”) (the “ *** Initial Pharmacological Evaluation Studies ”). Further, the Parties have agreed that Otsuka shall perform certain other Initial Pharmacological Evaluation Studies at its own facilities in Japan using certain Synthetic Cannabinoid(s) in combination with the Compound (the “ *** Initial Pharmacological Evaluation Studies” and together with the *** Initial Pharmacological Evaluation Studies, the “Studies” ). The Research Plan shall be updated by the JRC in accordance with the provisions of the Research Agreement to fully reflect the performance of the S tudies.

(C) The Research Agreement does not provide for the performance of Pre-Licence Development involving Selected BDCs or Synthetic Cannabinoid(s) in combination

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

with Compound and does not regulate the ownership of intellectual property arising from such activities. The Parties now wish to supplement the terms of the Research Agreement as set out herein.

IT IS NOW AGREED AS FOLLOWS:

1. SUPPLEMENTAL PROVISIONS RELATING TO COMPOUND

1.1 Shortly after the Amendment Effective Date, Otsuka will supply such quantities of the Compound specified below to the following address:

1.1.1 Name of Compound: ***

1.1.2 Quantity: ***

1.1.3 Shipping Address and recipient: ***

Otsuka shall bear the costs of freight, insurance and any other costs related to the supply of the Compound to the shipping address set forth above. Otsuka may supply additional amounts of Compound to GW Pharma in its sole discretion. GW Pharma shall transfer the quantities of Compound supplied to GW Pharma hereunder to University of Aberdeen and shall procure that University of Aberdeen supplies all such quantities of Compound to the Otsuka Scientists. The Parties understand and agree that all quantities of Compound supplied hereunder shall be used by the Otsuka Scientists solely in the performance of the *** Initial Pharmacological Evaluation Studies as specified in the Research Plan and shall be used for no other purposes by GW Pharma or the Otsuka Scientists. For clarity, the Studies are Initial Pharmacological Evaluation Studies and the terms of the Research Agreement shall apply in respect there to. With respect to the *** Initial Pharmacological Evaluation Studies, this means, inter alia , that t he Otsuka Scientists shall carry out the *** Initial Pharmacological Evaluation Studies in accordance with the Research Plan and otherwise in accordance with Sections 3.3 and 3.4 of the Research Agreement. The costs of the Studies will be funded in accordance with the terms of the Research Agreement.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.2 GW Pharma agree s that any information GW Pharma receives from Otsuka in relation to Compound (as opposed to information relating to Compound in combination with Selected BDCs or Synthetic Cannabinoid(s) generated pursuant to the performance of the Studies ) shall be Confidential Information of Otsuka and the provisions of Section 11 of the Research Agreement shall apply to such information.

1.3 Otsuka shall retain all right, title and interest to Compound and all Patent Rights and Know How relating to the Compound either (i) owned or controlled by Otsuka prior to the Amendment Effective Date or (ii) which is created, made, conceived or reduced to practice by or on behalf of Otsuka after the Amendment Effective Date outside of the Research Collaboration .

1.4 All Know How, Materials and Patent Rights arising from the performance of the Studies involving the use of Compound in combination with either Selected BDCs or Synthetic Cannabinoid(s) as specified in the Research Plan shall be Collaboration IP and shall be treated in accordance with Research Agreement. Anything to the contrary contained herein notwithstanding, w ith respect to any such Collaboration IP which claims or comprises a new use of Compound as a monotherapy (rather than a use of Compound in combination with a cannabinoid) GW Pharma agrees not to assert against Otsuka any breach of Section 12.1.2 of the Research Agreement based on the research, development, making, hav ing made, using or, importing, exporting, distribution, offer ing for sale, hav ing sold, or selling of Compound for such new use by or on behalf of Otsuka.

2. EFFECT

This Amendment No.1 shall be effective from the date first written above (the “ Amendment Effective Date ”).

3. REPRESENTATIONS AND WARRANTIES

No.1 has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

3.2 As of the Amendment Effective Date GW Pharma hereby represents and warrants to Otsuka that the quantities of Compound supplied hereunder by GW Pharma to University of Aberdeen shall be “Materials” as defined in the Collaboration Agreement between, inter alia , GW Pharma and the University Court of the University of Aberdeen effective 1 September 2007 (the “ Collaboration Agreement ”) copy of which is attached hereto, and the terms of the Collaboration Agreement will apply to such quantities of Compound.

4. REFERENCE TO AND EFFECT ON THE RESEARCH AGREEMENT

This Amendment No 1 effects an amendment to the Agreement, in accordance with the terms of Section 16.10 of the Research Agreement. Upon this Amendment No. 1 becoming effective each reference in the Research Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Research Agreement as supplemented hereby. Other than as supplemented by this Amendment No.1 the Research Agreement shall be otherwise unchanged. The terms of the Research Agreement (including without limitation, Sections 15 and 16.4) shall apply in respect of any issue or matter arising from or in connection with this Amendment No.1.

5. EXPENSES

Each Party shall pay all costs and expenses incident to its negotiation and preparation of this Amendment No.1 and to its performance and compliance with all agreements and conditions contained herein.

6. GOVERNING LAW

This Amendment No.1 shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to its choice of law provisions.

7. LANGUAGE

The English language shall be the language used for the interpretation of this Amendment No.1. If there is any inconsistency, discrepancy or contradiction between the English language version of this Amendment No.1 and any translation of this Amendment No.1 to any other language, the English language version shall prevail over any such translation.

8. DEFINITIONS

In this Amendment No.1 capitalized words and phrases shall have the same meaning as in the Research Agreement save as otherwise set out herein.

9. EXECUTION IN COUNTERPARTS

This Amendment No.1 may be executed in any number of counterparts, each of which shall be considered an original instrument, but all of which together shall be considered one and the same agreement, and shall become binding when one or more counterparts have been signed by and delivered to each of the Parties, it being understood that all Parties need not sign the same counterpart. A signed signature page faxed by one Party to another Party shall be deemed to constitute an original.

In Witness Whereof , the Parties have executed this Amendment No.1.

GW PHARMA LTD		OTSUKA PHARMACEUTICAL CO., LTD.


By:	/s/ Geoffrey Guy

Name:	Geoffrey Guy

Title:	Executive Chairman


By:	/s/ Justin Gover	By:	/s Kuniaki Natsume

Name:	Justin Gover	Name:	Kuniaki Natsume

Title:	Managing Director	Title:	Senior Operating Officer Director, Pharmaceutical Research

Exhibit 10.18

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated 29 June 2010

GW PHARMA LTD

and

OTSUKA PHARMACEUTICAL CO., LTD

AMENDMENT NO.2 TO RESEARCH COLLABORATION AND LICENCE AGREEMENT DATED JULY 9, 2007

Execution Copy

THIS AMENDMENT AGREEMENT (“ Amendment No.2 ”) is made the 29th day of June 2010 (the “ Second Amendment Date ”).

BETWEEN:

(2) OTSUKA PHARMACEUTICAL CO., LTD. , a Japan corporation, with its registered office at 2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (“ Otsuka ”).

WHEREAS:

(A) On July 9, 2007 GW Pharma and Otsuka entered into a research collaboration and licence agreement (the “ Research Agreement ”).

(B) The Parties amended the Research Agreement in accordance with the terms of Section 16.10 of the Research Agreement with effect from 14 March 2008 (“ Amendment No.1 ”) to allow the Otsuka Scientists (i) to perform certain Initial Pharmacological Evaluation Studies at the University of Aberdeen using certain Selected BDCs in combination with ***, and (ii) to perform certain other Initial Pharmacological Evaluation Studies in Japan using ***.

(C) Recognising the successes of, and the progress made by, the Parties to date from working collaboratively together under the Research Agreement, as well as the business opportunities which have been created thereunder and which remain to be exploited, the Parties now wish to further amend the Research Agreement, inter alia, to (i) extend the Research Term by three (3) additional years to a total of six (6) years and (ii) to increase the Research Fund to fund activities during the extended Research Term.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

IT IS NOW AGREED AS FOLLOWS:

1. The Parties hereby agree to extend the Research Term by an additional three (3) years from the day after the expiry of the third Research Year (1 July, 2010) until the end of the sixth Research Year (30 June, 2013) bringing the entire term of the Parties’ research activities under the Research Agreement to six (6) years and Section 1.1.78 of the Research Agreement is hereby deleted and replaced with the following:

“ Research Term ” shall mean a period commencing on the Effective Date and expiring at the end of the sixth Research Year (30 June, 2013). At the written request of either Party during the sixth Research Year, such request to be made on or before one hundred eighty (180) days prior to the end of such sixth Research Year, GW Pharma and Otsuka shall promptly discuss whether, and upon what basis, the Research Term should be extended for additional Research Year(s). Neither Party shall have any obligation to agree such extension, but if any extension is mutually agreed it shall become the “ Extended Research Term ”.

2. The Parties hereby agree to increase the Research Fund to fund activities during Research Years four (4) to six (6) and Section 1.1.76 of the Research Agreement is hereby deleted and replaced with the following:

“ Research Fund ” shall mean the fund of money to be provided by Otsuka to be used over the Research Term or Extended Research Term, to fund the performance of the Research Plan(s). Initially, the Research Budget for the conduct of the three (3) year Research Plan (covering Research Years one (1) to three (3)) was *** U.S. dollars ($***). The Research Budget for the conduct of the Research Plan(s) over Research Years four (4) to six (6) (from 1 July, 2010 to 30 June, 2013) shall be *** U.S. dollars ($***) but this amount may be increased from time to time by Otsuka in order to cover research and Pre-License Development activities to be performed during the Research Term or Extended Research Term.

3. F ollowing the Second Amendment Date, the Parties shall discuss in good faith, but not required to agree to, the possible changes to the Research Agreement relating to the following matter:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(a) Expansion of the GW/Otsuka CRI to University of Readings in addition to University of Aberdeen.

(b) Involvement of Otsuka Pharmaceutical Development & Commercialization Inc. in the Research Collaboration.

(c) Research Compounds and indications/therapeutic areas in the Research Field which GW Pharma may develop during the Research Term.

4. The Parties shall use reasonable efforts to complete their negotiations pursuant to Section 3 above and execute the necessary documents to implement the agreements terms reached, if any, as a result of such negotiations on or before 30 S ep tember 2010.

5 . The Parties hereby agree that a press release in the form set forth in the schedule hereto shall be publically announced by GW Pharma as soon as practicable upon signature of this Amendment No. 2. The public announcement of the hereto mutually agreed and scheduled press release shall not infringe any provision of Section 11 under the Research Agreement.

6 . Effect

6 .1 This Amendment No.2 shall be effective from the date first written above (the “ Second Amendment Effective Date ”).

7 . Representations and Warranties

7 .1 As of the Second Amendment Effective Date each Party hereby represents and warrants to the other Party that it (i) has the power and authority and the legal right to enter into this Amendment No.2 and to perform its obligations hereunder, and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Amendment No.2 and the performance of its obligations hereunder. This Amendment No.2 has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

8 . Reference to and Effect on the Research Agreement

8 .1 This Amendment No 2 effects an amendment to the Agreement, in accordance with the terms of Section 16.10 of the Research Agreement. Upon this Amendment No. 2 becoming effective each reference in the Research Agreement to “this Agreement,” “hereunder,” “hereof,” “herein” or words of similar import shall mean and be a reference to the Research Agreement as supplemented hereby. Other than as supplemented by this Amendment No.2 the Research Agreement shall be otherwise unchanged. The terms of the Research Agreement (including without limitation, Sections 15 and 16.4) shall apply in respect of any issue or matter arising from or in connection with this Amendment No.2.

9 . Expenses

9 .1 Each Party shall pay all costs and expenses incident to its negotiation and preparation of this Amendment No.2 and to its performance and compliance with all agreements and conditions contained herein.

1 0 . Governing Law

1 0 .1 This Amendment No.2 shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to its choice of law provisions.

1 1 . Language

1 1 .1 The English language shall be the language used for the interpretation of this Amendment No.2. If there is any inconsistency, discrepancy or contradiction between the English language version of this Amendment No.2 and any translation of this Amendment No.2 to any other language, the English language version shall prevail over any such translation.

1 2 . Definitions

1 2 .1 In this Amendment No.2 capitalized words and phrases shall have the same meaning as in the Research Agreement save as otherwise set out herein.

1 3 . Execution in Counterparts

1 3 .1 This Amendment No.2 may be executed in any number of counterparts, each of which shall be considered an original instrument, but all of which together shall be

considered one and the same agreement, and shall become binding when one or more counterparts have been signed by and delivered to each of the Parties, it being understood that all Parties need not sign the same counterpart. A signed signature page faxed by one Party to another Party shall be deemed to constitute an original.

In Witness Whereof , the Parties have executed this Amendment No.2.

GW PHARMA LTD		OTSUKA PHARMACEUTICAL CO., LTD.

By:	/s/ Geoffrey Guy

Name:	Geoffrey Guy

Title:	Executive Chairman

By:	/s/ Justin Gover	By:	Kuniaki Natsume

Name:	Justin Gover	Name:	Kuniaki Natsume

Title:	Managing Director	Title:	Senior Operating Officer

SCHEDULE

AGREED FORM PRESS RELEASE

GW and Otsuka Agree Three Year Extension to Global Cannabinoid Research

Collaboration

London, UK; Tokyo, Japan; June 30 2010: GW Pharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce that they have signed a three year extension to their global cannabinoid research collaboration. This collaboration was originally signed in July 2007 with a three year term, and the collaboration will now extend to the end of June 2013.

Under the research collaboration agreement, GW and Otsuka Pharmaceutical research a range of GW cannabinoids as potential new drug candidates in the field of Central Nervous System (CNS) disorders and oncology.

Over the next three years, Otsuka Pharmaceutical will make available a research fund of $12 million to cover research activities carried out under this Agreement. Otsuka Pharmaceutical has the discretion to increase this funding from time to time as the development of selected drug candidates advances.

Dr Geoffrey Guy, GW’s Chairman, said, “Over the last three years, the GW-Otsuka research collaboration has yielded highly promising data and new intellectual property for GW cannabinoids across a range of target indications within CNS and oncology. We are very pleased that Otsuka has elected to extend this collaboration and believe that this provides a significant endorsement of the potential of GW’s cannabinoid pipeline”.

Dr. Taro Iwamoto, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. said, “We are delighted with the progress of our collaboration with GW Pharmaceuticals in the investigation of cannabinoids as potential new medicines in the field of CNS and oncology. Over the last three years, GW and Otsuka have formed a strong close working relationship and we are excited to be extending our collaboration to develop and commercialize innovative new treatments in order to further our contribution to global well being”.

The GW-Otsuka research collaboration is led by a joint research team incorporating senior scientists from both companies. This team works in close collaboration with a number of leading cannabinoid scientists around the world in the evaluation of a range of GW cannabinoids as drug candidates within the field of CNS and oncology.

The objective of this collaboration is to select the most promising candidates for full clinical development, regulatory approval and global commercialization. Products selected for full development will be the subject of a license from GW. Under the terms of each product license, Otsuka Pharmaceutical will fund the global development and commercialization of such products, and GW will receive license fees, milestone payments and a long term commercial supply price and royalty. The financial terms of each license are to be agreed at the time of selection of each product for global development.

In addition to the research agreement, GW and Otsuka Pharmaceutical also collaborate in the development of Sativex ® , GW’s lead product, in the United States under an exclusive license agreement signed in February 2007. The initial target indication for Sativex in the US is as a treatment of pain in patients with advanced cancer, who experience inadequate analgesia during optimized chronic opioid therapy.

Enquiries:

For GW:
	GW Pharmaceuticals plc	Today: +44 20 7831 3113
	Dr Geoffrey Guy, Chairman	Thereafter: + 44 1980 557000
	Justin Gover, Managing Director

	Financial Dynamics	Tel: +44 20 7831 3113
	Ben Atwell / John Dineen

	Piper Jaffray Ltd	Tel: +44 20 3142 8700
	Neil Mackison / Rupert Winckler
For Otsuka
Pharmaceutical:	Masamitsu Kitada	kitadams@otsuka.jp

Notes to Editors

About Otsuka Pharmaceutical Co., Ltd

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: ‘Otsuka-people creating new products for better health worldwide,’ Otsuka researches, develops, manufactures and markets innovative and original products, with a focus on pharmaceutical products for the treatment of diseases and consumer products for the maintenance of everyday health. Otsuka is committed to being a corporation that creates global value, adhering to the high ethical standards required of a company involved in human health and life, maintaining a dynamic corporate culture, and working in harmony with local communities and the natural environment.

Otsuka Pharmaceutical Co., Ltd. is a wholly owned subsidiary of Otsuka Holdings Co., Ltd., the holding company for the Otsuka Group. The Otsuka Group comprises 145 companies and employs approximately 39,000 people in 23 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned ¥1,084.2 billion (approx. US $11.7 billion*) in annual revenues in fiscal 2009. Visit Otsuka Pharmaceutical Co., Ltd. at www.otsuka-global.com.

About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular multiple sclerosis and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant-based prescription pharmaceutical products and medicines containing controlled substances.. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. For further information, please visit www.gwpham.com

Exhibit 10.19

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

DEVELOPMENT AND LICENSE AGREEMENT

between

GW PHARMA LTD

and

GW PHARMACEUTICALS PLC

and

OTSUKA PHARMACEUTICAL CO., LTD

dated as of February 14, 2007

DEVELOPMENT AND LICENSE AGREEMENT

THIS DEVELOPMENT AND LICENSE AGREEMENT (the “ Agreement ”) is entered into as of February 14, 2007, by and among GW PHARMA LTD , a company organized under the laws of England, having offices at Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom, on behalf of itself and its Affiliates (collectively, “ GW Pharma ”), GW PHARMACEUTICALS PLC, a company organized under the laws of England, having offices at Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom and OTSUKA PHARMACEUTICAL CO., LTD. , a Japan corporation, having offices at 2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535, Japan (“ Otsuka ”). GW Pharma and Otsuka may be referred to herein individually as a “ Party ” or collectively as the “ Parties .”

RECITALS

WHEREAS , GW Pharma is the developer of a pharmaceutical preparation based upon mixtures of botanical extracts from the Cannabis sativa plant for use in the treatment of pain and has licensed the same for commercialization in certain countries around the world but not in the United States of America;

WHEREAS , GW Pharma has successfully established a pharmaceutically appropriate source of active botanical extracts from well characterized strains of Cannabis sativa grown by or on behalf of GW Pharma under appropriately controlled conditions;

WHEREAS , GW Pharma manufactures and packages commercial quantities of finished pharmaceutical product under current good manufacturing practices and delivers the same to its licensees;

WHEREAS , such pharmaceutical preparation is sold by the licensees of GW Pharma under the tradename Sativex ® oromucosal/buccal spray;

WHEREAS , GW Pharma possesses the right to grant licenses to the Licensed Intellectual Property (as defined below);

WHEREAS , Otsuka wishes to obtain, and GW Pharma is willing to grant at the Closing (as defined below), licenses under GW Pharma’s rights in the Licensed Intellectual Property on the terms and subject to the conditions set forth herein; and

WHEREAS , GW Pharmaceuticals plc guarantees the financial obligations of GW Pharma and is a party to this Agreement solely for the purpose of the guarantee set out in Section 14.

WHEREAS , it is the intention of the Parties to negotiate in good faith and as soon as practicable to enter into a research collaboration in the field of cannabinoids for the treatment of CNS and cancer indications with the understanding that the parties intend to enter into an agreement within one hundred and twenty (120) days of the date first above written based on the agreed principles set out in Exhibit E subject to the occurrence of the Closing pursuant to this Agreement.

AGREEMENT

NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto intending to be legally bound hereby agree as follows:

ARTICLE 1

DEFINED TERMS.

1.1 “ Additional Indication ” shall mean any indication other than the First Indication and the Second Indication, if any, as determined in the sole discretion of Otsuka.

1.2 “ Affiliate ” shall mean any corporation or other entity that controls, is controlled by, or is under common control with, a Party. A corporation or other entity shall be regarded as in control of another corporation or entity if it owns, or directly or indirectly controls, more than 50% of the voting securities or other ownership interest of the other corporation or entity or if it possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of the corporation or other entity. For purposes of this Agreement, Taiho Pharmaceutical Co., Ltd shall not be deemed to be an Affiliate of Otsuka.

1.3 “ Asia ” shall mean Japan, China, Taiwan, India, Thailand, Malaysia, Singapore, Indonesia, Philippines, South Korea, North Korea, Vietnam, Laos, Cambodia, Burma (Myanmar), Sri Lanka, Pakistan, Nepal, Hong Kong, Bangladesh, Bhutan, Sikkim, Papua New Guinea.

1.4 “ Average Minimum Price ” shall have the meaning provided in Section 4.4(b).

1.5 “ Average Unit Size Price ” shall have the meaning provided in Section 4.4(b)

1.6 “ Botanical Drug Substances ” or “BDS’ shall mean two liquid carbon dioxide extracts of a chemically and genetically characterized cannabis plant (i) in one case containing *** as the principal cannabinoid and (ii) in the other case containing *** as the principal cannabinoid.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.7 “ Branded Competitive Product ” shall mean any product, other than a Licensed Product, containing synthesized *** and *** in combination in any ratio where both synthetic cannabinoids are therapeutically active components according to the approved labeling of the product and/or extracted botanical *** and *** in combination in any ratio where both such cannabinoids are therapeutically active components according to the approved labeling of the product, following the market introduction of which there occurs a reduction of greater than *** percent (***%) in Net Sales of a Licensed Product in the Territory with respect to a calendar quarter as compared to the Net Sales for such Licensed Product in the same calendar quarter in the preceding year and which carries an indication approved by the FDA that is substantially equivalent i.e. the First Indication, the Second Indication or Additional Indications as the case may be.

1.8 “ CBD ” shall mean Cannabidiol.

1.9 “ cGMPs ” shall mean the then current and applicable good manufacturing practice regulations established in 21 C.F.R. Parts 210 and 211, as amended and in effect from time to time, and other applicable FDA policies and the Guide to GMP for Medicinal Products as promulgated under applicable European Directives and in effect from time to time during the term of this Agreement.

1.10 “ Change of Control ” shall mean the occurrence of a tender offer, stock purchase, other stock acquisition, merger, consolidation, recapitalization, reverse split, sale or transfer of assets or other transaction, as a result of which any Person other than an Affiliate of a Party gains Control of that Party. “Control” for purposes of this Section 1.10 refers to any of the following (i) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through ownership of voting securities, by contract or otherwise; (ii) ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or of fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; (iii) any other arrangement whereby a Party controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity.

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1.11 “ Clinical Samples ” shall have the meaning provided in Section 4.5.

1.12 “ Closing ” shall mean the consummation of the transactions contemplated by this Agreement on the Closing Date including, but not limited to, the grants of the licenses set forth in Article 2.

1.13 “ Closing Date ” shall mean the earlier of the second business day immediately following (i) the date on which the waiting period under the Hart Scott Rodino Antitrust Improvements Act expires or terminates early or (ii) all requests to the Parties by the Federal Trade Commission or the Justice Department, as the case may be, with regard to the transactions contemplated by this Agreement have been satisfactorily met and no objection on the part of the Federal Trade Commission or the Justice Department remains.

1.14 “ CMC Data ” shall mean the data and other know-how relating to the chemistry and manufacturing controls and other manufacturing processes for a Licensed Product including any such data included as part of an IND, NDA or FDA Regulatory Approval.

1.15 “ Combination Product ” means a product that contains, in addition to a Licensed Product, one or more other therapeutically active ingredients or a Third Party proprietary delivery system where the Third Party is due a payment upon the sale of such product.

1.16 “ Commercialization Plan ” shall have the meaning provided in Section 3.1.

1.17 “ Commercially Reasonable Efforts ” shall mean that level of effort which typically would be undertaken by a pharmaceutical company comparable to Otsuka in pursuing a mandated activity or goal pursuant to this Agreement in respect of a pharmaceutical product similar to any/each Licensed Product with similar market potential

and at a similar stage of development taking into account patent matters, competition, the costs of development and other relevant matters.

1.18 “ Confidential Information ” shall mean any confidential or proprietary information of a Party, including, without limitation, (i) information related to the Licensed Products, the Licensed Intellectual Property, GW Pharma Know-How, Otsuka Know-How, and Otsuka Clinical Data, and any other information relating to Licensed Product including Specifications, data, know-how, formulations, research projects, work in process, future developments, scientific, engineering, manufacturing, marketing, and business plans, financial or personnel matters relating to such Party, its present or future products, sales, suppliers, customers, employees, investors, or business; and (ii) the terms of this Agreement; in either case, whether in oral, written, graphic, electronic, or optical form. Notwithstanding the foregoing, Confidential Information shall not include any information which the receiving Party can prove by competent evidence:

(a) is now, or hereafter becomes, through no act or failure to act on the part of the receiving Party, generally known or available;

(b) is known by the receiving Party at the time of receiving such information, as evidenced by its records;

(c) is hereafter furnished to the receiving Party by a Third Party, as a matter of right and without restriction on disclosure; or

(d) is independently developed by or on behalf of the receiving Party, as evidenced by its records, by persons without knowledge of, and without the aid, application or use of, the Confidential Information of the disclosing Party.

Disclosures made hereunder which are specific, for example, as to techniques, equipment, processes, products, operating conditions and the like, shall not be deemed to be within the foregoing exceptions merely because they are embraced by general disclosures in the public domain or in the receiving Party’s possession. In addition, any combination of features shall not be deemed to be within the foregoing exceptions merely because individual features are in the public domain or in the receiving Party’s possession.

1.19 “ Control(led) ” shall mean possession of the ability at all pertinent times to grant a license or sublicense as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.

1.20 “ Damages ” shall have the meaning provided in Section 12.1(a).

1.21 “ DEA ” shall mean the United States Federal Drug Enforcement Administration or a successor agency.

1.22 “ DEA Regulatory Approval ” shall mean (i) designation of such Licensed Product by the DEA in a controlled drug schedule other than Schedule 1; and (ii) GW Pharma’s and Otsuka’s receipt of all federal permits, licenses and authorizations for Licensed Product required by GW Pharma and Otsuka from the DEA in order for them to perform their obligations under this Agreement and the Manufacture and Supply Agreement.

1.23 “ Development Plan ” shall mean any of the First Indication Development Plan, the Second Indication Development Plan, and any other development plan approved by JDC for an Additional Indication.

1.24 “ Direct Cost ” shall have the meaning provided in Section 4.5

1.25 “ FDA ” shall mean the United States Food and Drug Administration, or any successor agency thereto having the administrative authority to regulate the marketing of human pharmaceutical products or biological therapeutic products, delivery systems and devices in the United States of America.

1.26 “ FDA Regulatory Approval ” shall mean with respect to an indication for any Licensed Product, approval of the NDA for such Licensed Product for that indication and such FDA approvals as may be required for the manufacture of the Licensed Product and supply of the same for commercial sale and use.

1.27 “ Field ” shall mean the treatment, diagnosis, prevention, or palliation of diseases, conditions, syndromes, and maladies in humans and animals including, without limitation, the treatment of the symptoms of multiple sclerosis and the treatment of neuropathic pain, cancer pain, and other types of pain.

1.28 “ First Indication ’ shall mean an indication for the adjunctive treatment of advanced cancer pain.

1.29 “ First Indication Development Plan ” shall have the meaning provided in Section3.4(a).

1.30 “ Full Regulatory Approval ” shall mean (i) FDA Regulatory Approval, and (ii) DEA Regulatory Approval.

1.31 “ Fully Burdened Cost ” shall mean all direct costs plus a reasonable allocation of fixed and variable indirect costs associated with an activity that would be included in the cost of goods sold for the applicable product as determined in accordance with IAS.

1.32 “ GAAP ” shall mean generally accepted accounting principles in the USA, as amended from time to time and then in effect.

1.33 “ GCP ” shall mean the then current and applicable good clinical practice regulations established in the US Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Applications), as may be amended from time to time, and any other applicable FDA policies and the rules and regulations promulgated under applicable European Directives and in effect from time to time during the term of this Agreement.

1.34 “ Generic Competitive Product ” shall mean any product, other than a Licensed Product, that contains CBD Botanical Drug Substance and THC Botanical Drug Substance in combination (i) for which bioequivalence with a Licensed Product has been demonstrated to the satisfaction of the FDA and (ii) which has an indication for a Licensed Product approved by the FDA and (iii) which can be substituted for a Licensed Product for such indication by the dispenser and (iv) following the market introduction of which there occurs as a reduction of greater than *** percent (***%) in Net Sales in the Territory of a Licensed Product with respect to a calendar quarter as compared to the Net Sales for such Licensed Product in the same calendar quarter in the preceding year.

1.35 “ GLP ” shall mean the then current and applicable good laboratory practice regulations established in 21 C.F.R. Part 58, as amended and in effect from time to time, and other applicable FDA policies and the rules and regulations promulgated under applicable European Directives and in effect from time to time during the term of this Agreement.

1.36 “ GW Pharma ” shall have the meaning provided in the introductory paragraph to this Agreement.

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1.37 “ GW Pharma Indemnitee ” shall have the meaning provided in Section 12.1(b).

1.38 “ GW Pharma Know-How ” shall mean, to the extent (i) Controlled by GW Pharma on the Closing Date or at any time during the License Term and (ii) relating to Licensed Products, all data including, but not limited to, pharmacological, toxicological and other pre-clinical and clinical data, and other clinical information including Pre-Clinical Data, and analytical and quality control data pertaining to any Licensed Product, results, information, know-how, trade secrets, techniques, formulae, reagents, materials, methods, processes, assays, inventions (including, without limitation, all unpatented and unpatentable Inventions owned solely by GW Pharma or owned jointly by GW Pharma and Otsuka, but not those Inventions as to which patent applications are pending, which Inventions shall be dealt with in accordance with Sections 1.39 and 7.2), developments, materials, expertise, technology, standard operating procedures, tooling, manufacturing data and stability data, but excluding the Otsuka Clinical Data, Otsuka Know-How, the Otsuka Patent Rights, the GW Pharma Patent Rights, and the Joint Patents. GW Pharma Know-How that relates in any way to the manufacture or the process of manufacture of BDS or Licensed Products is “Manufacturing GW Pharma Know-How” and GW Pharma Know-How that is CMC Data is “GW Pharma CMC Data”.

1.39 “ GW Pharma Patent Rights ” shall mean the patents and patent applications set forth on Exhibit A attached hereto and incorporated herein and any other patents and patent applications (y) that (i) are Controlled by GW Pharma on the Closing Date or at any time during the License Term and (ii) are necessary to develop, make, have made, use, sell, offer for sale, import or otherwise exploit any Licensed Product in the Territory, or (z) that (iii) are Controlled by GW Pharma on the Closing Date or at any time during the License

Term and (iv) are useful to develop, make, have made, use, sell, offer for sale, import or otherwise exploit any Licensed Product provided that if any such patents and patent applications are in-licensed by GW Pharma from a Third Party they shall only be within the scope of this definition if Otsuka agrees to pay and pays to GW Pharma whatever fees are due to the Third Party under the in-license in relation to such use with the Licensed Products in the Territory, including in respect thereof (a) all re-examinations, reissues, renewals, extensions, and term restorations thereof within the Territory, if any, and (b) without limitation, all provisional applications, continuations, continuations-in-part, divisional, and substitute applications, and inventors’ certificates within the Territory, if any, including, but not limited to, any of the foregoing that claim Sole Patents of GW Pharma or Joint Patents owned jointly by GW Pharma and Otsuka.

1.40 “ IAS ” shall mean international accounting standards, as promulgated by the International Accounting Standards Board, or a successor organization, from time to time and then in effect.

1.41 “ IND ” shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the USA, or any other country in which such trials are to be conducted.

1.42 “ Indemnified Party ” shall have the meaning provided in Section 12.2.

1.43 “ Indemnifying Party ” shall have the meaning provided in Section 12.2.

1.44 “ Insolvency Officer ” shall mean a receiver, administrative receiver, administrator, liquidator, trustee, nominee or supervisor in respect of a company voluntary arrangement or scheme of arrangement or any other similar official that it would be possible

to appoint under applicable insolvency law to or over the assets of a company or other legal entity.

1.45 “ Insolvency Proceeding ” shall mean in respect of a company or other legal entity (i) the appointment of an Insolvency Officer or (ii) such company or legal entity becoming subject to a company voluntary arrangement, a scheme of arrangement or other composition or arrangement with or for the benefit of all or substantially all of such entity’s creditors.

1.46 “ Inventions ” shall have the meaning provided in Section 7.1.

1.47 “ Joint Commercialization Committee ” or “ JCC ” shall mean the committee formed pursuant to Section 3.3.

1.48 “ Joint Development Committee ” or “ JDC ” shall mean the committee formed pursuant to Section 3.5.

1.49 “ Joint Patents ” shall have the meaning provided in Section 7.2(a).

1.50 “ Law ” or “ Laws ” means all applicable laws, statutes, rules, regulations, orders, codes, judgments, guidance documents, and ordinances of any governmental authority, or securities listing authority such as a stock exchange.

1.51 “ License Term ” shall have the meaning provided in Section 10.1.

1.52 “ Licensed Intellectual Property ” shall mean the GW Pharma Patent Rights and the GW Pharma Know-How.

1.53 “ Licensed Products ” shall mean (i) the pharmaceutical product for human therapeutic use, a description of which is set forth on Exhibit B attached hereto and

incorporated herein (the “ Existing Licensed Product ”), finished, packaged, and labeled (regardless of where so finished, packaged, and labeled) either for use in clinical trials, marketing studies, or in a form being used for commercialization, (ii) any formulation improvement containing the same combination of BDSs, and (iii) any other product containing a combination of CBD Botanical Drug Substance and THC Botanical Drug Substance to THC Botanical Drug Substance is between *** and ***.

1.54 “ Licensed Trademarks ” shall mean the tradename Sativex® and such other names or marks set forth in the registrations or applications listed in Exhibit C attached hereto and incorporated herein and any other names, marks, and logos agreed by the Parties to be used in connection with the Licensed Products and licensed to Otsuka pursuant to Section 2.4.

1.55 “ Manufacturing and Supply Agreement ” means that agreement to be agreed in good faith between the Parties pertaining to the supply of GLP and cGMP Licensed Products by GW Pharma to Otsuka for use in testing and clinical development and for commercial sale.

1.56 “ Manufacturing Term ” shall have the meaning provided in the Manufacturing and Supply Agreement.

1.57 “ NDA ” shall mean a New Drug Application (as more fully defined in 21 C.F.R. Part 314.5 et seq.) and all amendments and supplements thereto (including sNDAs) filed with the FDA, including all documents, data, and other information concerning a pharmaceutical product which are necessary for submitting an application acceptable for filing for FDA Regulatory Approval to market and sell such pharmaceutical product.

1.58 “ Net Sales ” shall mean the gross amount invoiced by Otsuka, its Affiliates

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and sublicensees (where so permitted under Section 2.1 or Section 2.4) for all sales of Licensed Products to Third Parties during a relevant period, less the following items arising during the same relevant period regardless as to whether they are related to the same sales: (i) discounts, including cash and quantity discounts and adjustments arising from consumer discount programs actually paid, granted or accrued and required distribution commissions/fees granted or given to wholesalers or other distributors, all of the foregoing to the extent reasonable and customary, (ii) amounts for credits, rebates or allowances for price adjustments including chargeback payments and rebates or fees granted or given to buying groups, healthcare insurance carriers, managed healthcare organizations or to federal, state, or local governments (or their respective agencies, purchasers, and reimbursers) or to trade customers, billing errors, damaged or defective goods, rejections or returns of Licensed Products not replaced, including recalls or withdrawals of a Licensed Product, subject to the provisions of Section 8.1(i), where such amounts in any period are good faith estimates that reflect the position in previous periods, if any, and will be the same amounts used for the purposes of the audited amounts of Otsuka, its Affiliates and sublicensees (iii) freight, postage, shipping and insurance charges actually allowed or paid for delivery of Licensed Products, to the extent actually billed, and (iv) taxes, duties, or other governmental charges (other than income taxes) actually levied on, or otherwise imposed on sales of Licensed Products.

Net Sales of any Licensed Product that is sold as a Combination Product will be determined by multiplying the total Net Sales of the Combination Product by the fraction A/(A+B), where A is the average price paid per Unit of the Product when sold separately in finished form in the Territory and B is the sum of the average prices paid per Unit for products containing the other active ingredients in the Combination Product when sold separately in finished form in the Territory. If such average invoice prices cannot be

determined for both the Licensed Product and the product(s) containing such other ingredient(s) and in all cases where the Combination Product contains a proprietary delivery system where the Third Party is due a payment upon the sale of such Combination Product, the Parties will negotiate in good faith regarding the calculation of Net Sales for the applicable Combination Product, based on the relative value contributed by each component.

Each of the foregoing deductions shall be determined as incurred in the ordinary course of business and in accordance with GAAP in the United States. All deductions for payments in respect of sales to any governmental authority, any government subsidized program, or any managed care or similar organization, which deductions apply collectively to multiple pharmaceutical products, shall be fairly allocated to the amounts invoiced for Licensed Products.

1.59 “ Otsuka ” shall have the meaning provided in the introductory paragraph to this Agreement.

1.60 “ Otsuka Clinical Data ” shall mean the results arising from the conduct of those Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies, and Phase IV Clinical Studies which are carried out under the Development Plan either by or on behalf of GW Pharma or Otsuka, and which have been funded by Otsuka under this Agreement, and the results of which are included in any NDA or any amendment thereto as mandatory prerequisites to obtain FDA Regulatory Approval. For clarity, Otsuka Clinical Data shall not include GW Pharma CMC Data.

1.61 “ Otsuka Indemnitee ” shall have the meaning provided in Section 12.1(a).

1.62 “ Otsuka Know-How ” shall mean, to the extent (i) Controlled by Otsuka and arising after the Closing Date during the License Term and (ii) introduced by Otsuka for use

with a Licensed Product under a Development Plan or generated under such a Development Plan, and in either case used with a Licensed Product, all information, know-how, trade secrets, techniques, methods, processes, assays, inventions (including, without limitation, all unpatented and unpatentable Inventions owned solely by Otsuka or owned jointly by GW Pharma and Otsuka, but not those Inventions as to which patent applications are pending, which Inventions shall be dealt with in accordance with Sections 1.63 and 7.2), developments, materials, or compositions of matter of any type or kind, marketing reports, expertise, formulas, technology, and including, in relation to commercialization of a Licensed Product, confidential information relating to the commercialization of such Licensed Product in the Territory, designs used in the trade dress of a Licensed Product in the Territory and any form of advertisement in whatever media or other marketing or promotional materials which have been generated by or upon behalf of Otsuka, its Affiliates, or sub-licensees in relation to commercialization of Licensed Products in the Territory, but in each case excluding the GW Pharma Know-How, the GW Pharma Patent Rights, Pre-Clinical Data, Otsuka Patent Rights, Otsuka Clinical Data, the Joint Patents, and all Otsuka business methods and systems including, but not limited to, software and procedures using in accounting, finance, sales, and the collection of safety data.

1.63 “ Otsuka Patent Right s” shall mean any patents and patent applications (i) Controlled by Otsuka during the License Term and (ii) claiming or covering inventions used to develop, make, have made, use, sell, offer for sale, import or otherwise exploit any Licensed Product in the Territory and introduced into the development of such Licensed Product by Otsuka under a Development Plan, including in respect thereof (a) all re-examinations, reissues, renewals, extensions and term restorations thereof within the Territory, if any, and (b) without limitation, all provisional applications, continuations, continuations-in-part, divisional and substitute applications, and inventors’ certificates within

the Territory, if any, including, but not limited to, any of the foregoing that claim Sole Patents of Otsuka or Joint Patents owned jointly by Otsuka and GW Pharma.

1.64 “ Party ” and “ Parties ” shall have the respective meanings provided in the introductory paragraph to this Agreement.

1.65 “ Pharmcovigilence Agreement ” shall have the meaning provided in 8.1(e).

1.66 “ Phase I Clinical Study ” means a clinical study of a Licensed Product in human volunteers or patients with the endpoint of determining initial tolerance, toxicity, safety and/or pharmacokinetic information, including a clinical study that would satisfy the requirements of 21 C.F.R. 312.21(a).

1.67 “ Phase II Clinical Study ” means a clinical study of a Licensed Product on patients, the principal purpose of which is to establish clinical proof of principle and to obtain sufficient information about such Licensed Product’s safety and efficacy to permit the design of further clinical studies, and that would satisfy the requirements of 21 CFR § 312.21(b).

1.68 “ Phase III Clinical Study ” means a human clinical study of a Licensed Product in patients, (a) which is designed to: (i) establish that a Licensed Product is safe and effective for its intended use; (ii) define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (iii) elicit data sufficient for FDA Regulatory Approval of such Licensed Product; and (b) that would satisfy the requirements of 21 CFR § 312.21(c), but for the avoidance of doubt excluding any Phase IIb study, QT study, or any study of safety and/or tolerability.

1.69 “ Phase IV Clinical Study ” means a clinical study of a Licensed Product commenced after FDA Regulatory Approval for such Licensed Product in order to (a)

support Commercialization of the Product, or (b) fulfill a post-approval study commitment or undertaking imposed by the FDA.

1.70 “ Pre-Clinical Data ” shall mean the results arising from the conduct of those pre-clinical and non-clinical studies which are carried out under the Development Plan whether by GW Pharma or Otsuka or CROs or other researchers appointed by either of them.

1.71 “ Product Royalty ” shall have the meaning provided in Section 4.7.

1.72 “ Promotional Samples ” shall have the meaning provided in Section 4.5.

1.73 “ Qualifying Pharmaceutical Company ” shall mean any publicly listed company trading as a pharmaceutical or biotechnology company with a market capitalization of more than US$***, to be assessed on the day prior to the closure of the Change of Control.

1.74 “ Second Indication ” shall mean ***.

1.75 “ Second Indication Development Plan ” shall have the meaning provided in Section 3.4(a).

1.76 “ Sole Patents ” shall mean patent rights claiming or disclosing Inventions owned solely by such Party pursuant to the terms of Section 7.1

1.77 “ Specifications ” shall have the meaning provided in the Manufacturing and Supply Agreement.

1.78 “ Supply Compensation ” shall have the meaning provided in Section 4.4.

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1.1 “ Tentative Average Unit Price ” shall have the meaning provided in Section 4.4(a)

1.2 “ Territory ” shall mean the United States of America together with all of its territories and possessions, and the Commonwealth of Puerto Rico.

1.3 “ THC ” shall mean delta-9-tetrahydrocannabinol.

1.4 “ Third Party ” shall mean any entity other than Otsuka or GW Pharma or an Affiliate of Otsuka or GW Pharma.

1.5 “ Third Party Claims ” shall have the meaning provided in Section 12.1(a).

1.6 “ Unit ” shall mean a single unit of a fully finished, packaged and labeled Licensed Product (e.g., a box containing one or more spray vials or a container of tablets regardless of the number of doses contained in the unit) of a particular Unit Size.

1.7 “ Unit Size ” means the size of presentation of any given Licensed Product (e.g. 5.5 ml or 10 ml).

1.8 “ Valid Claim ” means a claim of an issued, unexpired patent within GW Pharma Patent Rights that has not been dedicated to the public, disclaimed, abandoned or held invalid or unenforceable by a court or other body of competent jurisdiction in an unappealed or unappealable decision, and that has not been explicitly disclaimed, or admitted by GW Pharma in writing to be invalid or unenforceable or of a scope not covering a Licensed Product through reissue, disclaimer or otherwise.

ARTICLE 2

GRANT OF LICENSE.

2.1 License Grant to Otsuka . Subject to the terms and conditions of this Agreement, GW Pharma hereby grants to Otsuka commencing at the Closing and during the License Term an exclusive (even as against GW Pharma), royalty-bearing license (including the right to sublicense (i) to Third Parties, subject to the consent of GW Pharma which shall not be unreasonably withheld or delayed and (ii) to Affiliates without any required consent of GW Pharma), under the Licensed Intellectual Property to develop, make, have made, use, sell, offer for sale, import, and otherwise exploit Licensed Products in the Field in the Territory and a non-exclusive paid-up license to make and have made Licensed Products outside the Territory, but only for use within the Territory. For clarity it is agreed that Otsuka shall not be permitted to contract out the sales and marketing of the Licensed Products other than to an Affiliate nor shall it be permitted to sub-license the same other than to an Affiliate (and it shall be reasonable for GW Pharma to withhold its consent to any such sub-license). If, where so permitted under this Agreement Otsuka sub-licenses the rights granted to it hereunder to an Affiliate it does so subject to the condition that Otsuka shall remain responsible for all of its obligations hereunder and if the acts or omissions of any such sub-licensee cause Otsuka to be in breach of this Agreement Otsuka shall be responsible therefor regardless of any remedy which Otsuka may have against the sub-licensee for breach of the sub-license.

2.2 Manufacturing Rights . The Parties agree that Otsuka shall have no right to exercise its license right granted under Section 2.1 to use the Manufacturing GW Pharma Know-How or GW Pharma CMC Data to make and have made Licensed Products or BDS

unless and until it is permitted to do so under the terms of the Manufacturing and Supply Agreement.

2.3 License Grant to GW Pharma . Subject to the terms and conditions of this Agreement, Otsuka hereby grants to GW Pharma for itself and its Affiliates commencing at the Closing and during the License Term an exclusive royalty-free license, including the right to sublicense under Otsuka Clinical Data, Otsuka Know-How, Otsuka Patent Rights, to develop, make, have made, use, sell, offer for sale, import and otherwise exploit (or to have done any such activities on its behalf) Licensed Products (but only Licensed Products) for commercialization by GW Pharma, its Affiliates and sublicensees in the Field solely outside of the Territory.

2.4 Trademarks License . Subject to the terms and conditions of this Agreement including, but not limited to, Section 7.5, GW Pharma hereby grants to Otsuka commencing at the Closing and during the License Term an exclusive license, including the right to sublicense to Third Parties, subject to the consent of GW Pharma, which shall not be unreasonably withheld or delayed, to use the Licensed Trademarks in connection with the marketing, promotion, distribution and/or sale of goods covered by the registrations or applications for the Licensed Trademarks in the Territory but only in connection with the Licensed Products.

2.5 Disclosure of Know-How and Clinical Data . Commencing promptly after the Closing and from time to time thereafter during the License Term, (i) GW Pharma shall disclose to Otsuka all of the GW Pharma Know-How as is necessary or useful to enable Otsuka to exercise fully the licenses granted by GW Pharma (always excluding the Manufacturing GW Pharma Know-How until Otsuka is entitled to manufacture under Section 2.2) and (ii) Otsuka shall disclose to GW Pharma the Otsuka Clinical Data and Otsuka Know-

How as it arises to enable GW Pharma to exercise fully the licenses granted by Otsuka to GW Pharma hereunder.

2.6 Rights in Asia . In the event GW Pharma, after the Closing, should desire to seek a licensee for the development and/or commercialization of one or more Licensed Products in Asia, GW Pharma shall so notify Otsuka, which shall have the opportunity to negotiate with GW Pharma in good faith the terms and conditions of one or more agreements pertaining to such relationship before GW Pharma provides such an opportunity to any Third Party. The foregoing shall not obligate the Parties to reach agreement. If a term sheet is not agreed upon within *** days of the notice to Otsuka or definitive agreements are not executed within *** days following agreement upon the term sheet, GW Pharma may offer such rights to and conclude an agreement or agreements with any Third Party. In the event GW Pharma should desire to seek a license for the development and/or commercialisation of one or more products in Australia and/or New Zealand it shall discuss the same with Otsuka to identify whether the Parties can agree to apply the provisions of this Section 2.6 to such countries.

ARTICLE 3

DEVELOPMENT AND COMMERCIALIZATION PROGRAM.

3.1 Commercialization of Licensed Products . Commencing at the Closing, Otsuka shall have the exclusive right, and shall use Commercially Reasonable Efforts, to commercialize one or more Licensed Products in the Territory, which have been the subject of Full Regulatory Approval in relation to each Licensed Product for each indication,

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to a commercialization plan for each Licensed Product for each indication to be agreed upon by the JCC (the “Commercialization Plan”). Within the earlier of (i) twenty-four (24) months following creation of the JCC or (ii) eighteen (18) months prior to anticipated FDA Regulatory Approval of Licensed Product for the First Indication, Otsuka shall submit a preliminary draft commercialization plan for Licensed Product for the First Indication for review and agreement by the JCC. Commercialization plans shall address such matters as brand management, opportunity assessment, pricing, forecasting, market analysis, tactics and strategies, as may be determined by the Parties. Each commercialization plan shall be updated annually.

3.2 Commercialization . Pursuant to the Commercialization Plan, Otsuka shall position the Licensed Products under the Licensed Trademarks in the Territory following Full Regulatory Approval, including, without limitation, under the Sativex® trademark or such other trademark as may be determined unanimously by the JCC (in which regard the dispute resolution mechanisms provided for in this Agreement may be invoked but Otsuka shall not have a casting vote). Otsuka, its Affiliates and sublicensees shall use the Licensed Trademarks only, and in unaltered form, in connection with the commercialization and sale of the Licensed Products. If at any time the Parties should decide to use substitute trademarks or to establish other trademarks for use in connection with the Licensed Products, all such trademarks shall be owned by GW Pharma. Otsuka shall assign its interest, as it may exist, in any such trademarks to GW Pharma at no cost to GW Pharma. Otsuka shall be responsible for selling and marketing expenses for the Licensed Products within the Territory. GW Pharma shall provide commercially reasonable cooperation to Otsuka by providing, at no additional cost to Otsuka, access to any clinical and other data and information in GW Pharma’s possession or control which are reasonably accessible without undue expense to

GW Pharma and which are potentially useful in the sale and marketing of the Licensed Products in the Territory.

3.3 Joint Commercialization Committee . The Parties shall establish a Joint Commercialization Committee (“JCC”) promptly following the Closing. The JCC shall oversee (i) commercialization of Licensed Products in the Territory during the License Term and (ii) operation of the JDC and its subcommittees. Each Party’s designated co-chair of the JDC shall be a member of the JCC by virtue of such position on the JDC. Each Party shall appoint two (2) additional members to the JCC, with each Party designating one of its representatives as a co-chair of the JCC. The JDC and its sales and marketing subcommittee shall report directly to the JCC.

3.4 Development Plan and Activities .

(a) The JDC (defined below) shall oversee a development plan (as such plan may be amended from time to time by the JDC) pertaining to the development of the Existing Licensed Product for the First Indication, a copy of which, in initial form, together with the associated budgets and timelines is attached hereto as Exhibit D and incorporated herein (the “ First Indication Development Plan ”). Otsuka shall not be entitled to use its deciding vote on JDC or JCC so as to derogate from the right of GW Pharma to manage and conduct the development activities under the First Indication Development Plan. Following the Closing Date, the Parties shall prepare a development plan for the Second Indication, which shall be presented for consideration and approval by the JDC (the “ Second Indication Development Plan ”). Under the Second Indication Development Plan and other future development plans for Additional Indications activities will primarily be managed and conducted by Otsuka at its own cost and expense save that GW Pharma shall be responsible for the generation of all relevant CMC Data at its own cost and expense. The Parties

acknowledge their respective regulatory responsibilities set forth in Article 8 and elsewhere herein, and agree otherwise to work together to develop the Existing Licensed Product for the First Indication in accordance with the Development Plan and for the Second Indication in accordance with the Second Indication Development Plan. The First Indication Development Plan sets forth, and the Second Indication Development Plan and other Development Plans will set forth, the activities to be undertaken in connection therewith by each of the Parties including pre-clinical and clinical activities, as well as the budgets and timelines therefor. All activities carried out in relation to any Development Plan (other than generation of the CMC Data) will be financed by Otsuka including all activities to be managed and conducted by GW Pharma in accordance with such Development Plan. No development activities shall be carried out by either Party in relation to a Licensed Product in the Territory under this Agreement save under a Development Plan approved and governed by JDC.

(b) GW Pharma shall, in consultation with Otsuka through the JDC and/or the JCC, design and prepare a plan for Phase II Clinical Studies and Phase III Clinical Studies along with any other pre-approval studies required as a condition for Full Regulatory Approval for the Licensed Product for the First Indication in the Territory together with the preparation of all final study reports in support of the NDA in order to maximize market potential. Otsuka shall reasonably cooperate in such activities.

(c) GW Pharma shall be the owner of the IND for the First Indication for the Phase I Clinical Studies, Phase II Clinical Studies, Phase III Clinical Studies and Phase IIIb Clinical Studies and any subsequent INDs covering Licensed Product for the Second Indication and Additional Indications, until such time as Otsuka has filed in its own name the NDA covering Licensed Product for the First Indication. Once Otsuka has filed the NDA covering Licensed Product for the First Indication, GW Pharma shall promptly

transfer to Otsuka any IND, if held, covering Licensed Product for the Second Indication and Additional Indications and Otsuka shall assume responsibility for filing, in its own name, any subsequent INDs for the Second Indication or Additional Indications, as appropriate. Otsuka shall be the owner of the NDA and the subsequent FDA Regulatory Approval covering Licensed Product for the First Indication and for the NDA and subsequent FDA Regulatory Approval for the Second Indication and Additional Indications. Otsuka shall pay the maintenance fees for all FDA Regulatory Approvals and any DEA Regulatory Approvals irrespective of which party owns the same. Otsuka shall be responsible for the design and conduct of all clinical studies in support of the Second Indication and any Additional Indications. Regulatory affairs shall otherwise be governed by Article 8.

(d) GW Pharma shall develop all CMC Data necessary for submission of an NDA for the Licensed Products for any indication, which for the First Indication and Second Indication shall be at the cost of GW Pharma and which for Additional Indications and other Licensed Products to be agreed by the JDC but no such proposal for GW Pharma to develop CMC Data for Additional Indications or such other Licensed Products shall obligate GW Pharma to incur the costs thereof without its consent.

3.5 Formation and Function of Joint Development Committee . Promptly after the Closing, the Parties will form a Joint Development Committee (the “JDC”). The activities of the JDC shall be performed primarily though its subcommittees. The JDC shall establish such number of subject matter specific subcommittees from time to time as it sees fit, with an initial subcommittee addressing each of the following matters: (i) pre-clinical activities; (ii) clinical and regulatory activities including supervision and agreement of regulatory strategy; (iii) manufacturing and production activities; and (iv) sales and marketing. Each subcommittee shall be comprised of an equal number of representatives

from GW Pharma and Otsuka, such number to be established by the JDC. Each Party shall endeavor to appoint to the various subcommittees representatives qualified by experience or training. GW Pharma and Otsuka each shall appoint a co-chair for each subcommittee. Each such co-chair, by virtue of such position, shall be a member of the JDC. In addition, each of GW Pharma and Otsuka shall appoint an additional member of the JDC. Each of GW Pharma and Otsuka shall designate a co-chair of the JDC from among their respective representatives, who shall be a member of such Party’s senior management.

3.6 Procedural Rules . Subject to the dispute resolution mechanism set forth below, all decisions of the JCC, the JDC, and their respective subcommittees shall be unanimous, with each Party collectively having one (1) vote, which shall be cast by its co-chair. In the case of a tied vote, Otsuka’s vote shall control; provided, however, no action taken by virtue of Otsuka’s controlling vote shall obligate GW Pharma to incur expenses or assume liabilities in addition to those contemplated by this Agreement, the First Indication Development Plan and the Second Indication Development Plan or to derogate from GW Pharma’s right to manage and conduct the development activities under the First Indication Development Plan. The JCC shall meet no less frequently than two (2) times each year and the JDC shall meet at least four (4) times each year so long as the Development Plan continues. Such meetings may be conducted by videoconference, teleconference or in person, as agreed by the Parties, and the Parties shall agree upon the time of meetings. Unless otherwise agreed to by the Parties, in-person meetings shall alternate between locations of the Parties. No meeting of the JCC, the JDC or any of their respective subcommittees shall take place without the attendance of both co-chairs (or their alternates designated in writing) of such body. Written minutes of each meeting shall be prepared with the Parties alternating responsibility for the preparation thereof. Minutes shall not become effective until approved by the committee or subcommittee to which they relate. As a general matter, minutes will be

circulated at least seven (7) days in advance of the next ensuing meeting of the committee or subcommittee to which they relate. A reasonable number of additional representatives of a Party may attend meetings of the JCC, the JDC, or any of their respective subcommittee meetings in a non-voting capacity.

3.7 JCC and JDC Dispute Resolution . If the event of a deadlock regarding any issue coming before a subcommittee of the JDC, the issue in question may be referred to the JDC by either of the subcommittee co-chairs for resolution. The referral shall require the referring co-chair to prepare a written statement of the issue and present the same substantially simultaneously to the other co-chair and the JDC. The receiving co-chair shall have seven (7) days thereafter within which to present a written response to the JDC and the other co-chair. Following such seven (7) day period, the JDC shall endeavor to resolve the issue using whatever procedures it deems appropriate for the purpose. If the issue has not been resolved by the JDC within thirty (30) days of referral, the co-chairs of the JDC shall refer the matter to the JCC for resolution unless they unanimously determine the issue to be immaterial. Thereafter, the co-chairs of the JDC shall have seven (7) days within which to present their respective positions on the issue in question in writing to the JCC. Following such seven (7) day period, the JCC shall endeavor to resolve the issue using whatever procedures it deems appropriate for the purpose. If the issue has not been resolved by the JCC within thirty (30) days of referral, Otsuka shall have the deciding vote save as specified elsewhere in this Agreement. Disputes arising at the JDC shall be referred to the JCC pursuant to the above-described procedures. If a dispute arises at the JCC, one of the co-chairs may declare the matter to be in dispute and thereafter each of the JCC co-chairs shall have seven (7) days within which to present their respective positions on the issue in writing to the JCC. Following such seven (7) day period, the JCC co-chairs shall endeavor to resolve the issue using whatever procedures they deem appropriate for the purpose. If the issue has

not been resolved by the JCC within thirty (30) days of declaration, Otsuka shall have the deciding vote save as specified elsewhere in this Agreement. The JCC shall be entitled to shorten the times within which action must be taken pursuant to the foregoing dispute resolution procedures on an issue-by-issue basis in order to expedite the resolution of time sensitive issues. The JCC shall have authority, as set forth in this Section 3.7, to resolve only those disputes that relate to the content or performance of (i) any development plan including, but not limited to, the First Indication Development Plan and the Second Indication Development Plan and (ii) any commercialization plan including, but not limited to, the Commercialization Plan. Disputes falling within the authority of the JCC shall not be subject to resolution pursuant to the provisions of Sections11.1 and 11.2.

3.8 Development and Commercialization Responsibilities of the Parties . Following the Closing, Otsuka shall use Commercially Reasonable Efforts to develop Licensed Product for the First Indication and the Second Indication so as to achieve launch and commercialization of the same in the Territory as specified in the First Indication Development Plan and Second Indication Development Plan and according to the terms of this Agreement. Following the Closing, GW Pharma shall diligently perform its obligations regarding development and Full Regulatory Approval of the Licensed Products as set forth in this Agreement and the First Indication Development Plan and the Second Indication Development Plan and any other Development Plan agreed upon by the Parties. Otsuka shall be solely responsible for, and shall have full control of, commercialization of the Licensed Products including, marketing and sales activities in the Territory and post FDA Regulatory Approval risk minimization action plans. Commercialization activities shall be conducted according to the provisions of each Commercialization Plan agreed upon by the JCC. Otsuka’s performance of its development and commercialization obligations, as set forth in

this Section 3.8, shall be subject to the timely performance by GW Pharma of those of its development and commercialization obligations that are predicates to performance by Otsuka.

3.9 Cooperative Effort . Following the Closing, GW Pharma shall make available to Otsuka the results of preclinical studies and clinical studies of Licensed Products conducted outside the Territory both prior to and after the Closing and shall consult with Otsuka at such time as it may be planning to commence clinical studies for the Licensed Products outside the Territory for the purpose of considering study design suggestions of Otsuka that may enhance the utility of the resulting data for purposes of marketing, or seeking approval of, the Licensed Products in the Territory. Otsuka shall make available to GW Pharma the Otsuka Clinical Data with respect to studies conducted in the Territory and shall consult with GW Pharma at such time as it may be planning to commence clinical trials for the Licensed Products in the Territory for the purpose of considering study design suggestions of GW Pharma that may enhance the utility of the resulting data for purposes of seeking approval for the Licensed Products outside the Territory.

ARTICLE 4

PAYMENT OBLIGATIONS.

4.1 License Fee . Subject to Section 5.2, as consideration for the licenses granted to Otsuka under Article 2, GW Pharma shall submit an invoice to Otsuka for the License Fee as soon as practicable after the Closing Date and Otsuka shall pay to GW Pharma US$ 18.0 million no later than three (3) business days after the submission of the invoice.

4.2 Estimated Development Costs . The budget set forth in the First Indication Development Plan (the “Development Budget”) shall set out the Third Party costs projected to be incurred by GW Pharma in the performance of its obligations under such Development

Plan (including the cost to GW Pharma of relevant clinical trial insurance) other than the costs to GW Pharma of generating the CMC Data (“Development Costs”). The Development Budget shall estimate the Development Costs to be incurred by GW Pharma for each calendar quarter of each calendar year covered by such Development Budget. GW Pharma shall submit the first invoice in respect of GW Pharma’s estimated Development Costs from the Closing Date until the end of the first full calendar quarter after the Closing Date to Otsuka as soon as practicable following the Closing Date and this first invoice shall be payable within ten (10) days of its submission. Otsuka shall, upon receipt of GW Pharma’s invoices (other than for this first period) at least 30 days in advance, pay to GW Pharma GW Pharma’s estimated Development Costs for such calendar quarter by the 1 st day of such calendar quarter. GW Pharma shall submit to Otsuka via the JDC a progress report and to Otsuka itself copies of invoices paid by GW during such calendar quarter to Third Parties for the performance of Development Plan activities within ten (10) days of the end of each such calendar quarter or within forty-eight (48) hours of their receipt from the Third Party, if later. Each progress report shall, without limitation, set forth in respect of clinical studies managed or conducted by GW Pharma under the Development Plan, the number of screened subjects, the number of enrolled subjects, the number of withdrawn or discontinued subjects, the number of completed subjects and such other information as may be reasonably requested by Otsuka. Pre-clinical studies conducted or managed by GW Pharma under the Development Plan and paid by Otsuka shall become a subject of the progress report due following the calendar quarter in which such pre-clinical study was completed. In respect of any such pre-clinical study, the progress report shall include the study report for such pre-clinical study and copies of all invoices paid by GW to Third Parties in respect of the performance of such pre-clinical study. The Parties shall discuss and agree any other information or data to be included in the format for the progress report.

In the event the JDC or JCC (as applicable under Section 3.7) make any change to the First Indication Development Plan resulting in an increase or decrease in Development Costs, the JDC or JCC (as applicable) shall also make corresponding changes to the Development Budget for the First Indication and the payments to be made to GW Pharma pursuant to this Section 4.2 shall be increased or decreased accordingly to reflect the change in the Development Budget for the First Indication. If during the course to the First Indication Development Plan, either Party comes to believe that Development Costs for the First Indication are likely to exceed by ***% or more the estimated Development Costs, such Party shall notify the relevant JDC sub-committee at its next meeting, together with the reasons for the same. GW Pharma shall not incur amounts in excess of such *** per cent. (***%) increase without the consent of the JDC. Upon approval by the JDC, the Development Budget (and payments made to GW Pharma under this Section 4.2) shall be amended to reflect the decision of the JDC in respect of such increase or decrease to the Development Budget. Any clinical trial agreements performed by or on behalf of GW Pharma for which Otsuka is obligated to pay pursuant to this Agreement shall contain a provision requiring the return of funds advanced to any clinical site or clinical investigator in respect of services not actually performed. GW Pharma shall conduct each pre-clinical study and each clinical study for which it is responsible under this Agreement or a Development Plan or require each pre-clinical research organization or clinical research organization, as the case may be, engaged for such purposes to conduct each such pre-clinical study in accordance with GLP and each clinical study in accordance with GCP. Clinical trial insurance obtained by GW Pharma for the conduct of clinical trials under the First Indication Development Plan shall include Otsuka as an additional named insured.

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4.3 Actual Development Costs . In the event actual Development Costs paid by GW Pharma to Third Parties in a calendar quarter exceed the estimated Development Costs paid by Otsuka to GW Pharma for such quarter (including any surplus Development Cost payment previously made by Otsuka to GW Pharma and carried over from a previous quarter) as documented in a progress report (including invoices) supporting the excess of actual over estimated Development Costs for such calendar quarter, Otsuka shall, within thirty (30) days of its receipt of an invoice for the excess difference from GW Pharma, pay GW Pharma an amount equal to the excess difference of actual over estimated Development Costs.

In the event actual Development Costs paid by GW Pharma to Third Parties in a calendar quarter fall below the estimated Development Costs paid by Otsuka to GW Pharma for such quarter (including any surplus Development Cost payment previously made by Otsuka to GW Pharma and carried over from a previous quarter) as documented in a progress report (including invoices) supporting such overpayment by Otsuka of Development Costs for such calendar quarter, GW Pharma shall reduce the next estimated Development Cost payment invoiced to Otsuka hereunder by the entire amount of Otsuka’s overpayment. If Otsuka’s overpayment exceeds the next estimated Development Cost payment, GW Pharma shall subtract the full amount of any such remaining overpayment from successive invoices to Otsuka for Development Costs. If, at the completion of the Development Plan, any overpayment by Otsuka of estimated over actual Development Costs remains, GW Pharma shall promptly return such overpayment to Otsuka.

4.4 Supply Compensation. With respect to Licensed Products supplied to Otsuka pursuant to the Manufacturing and Supply Agreement, Otsuka shall pay to GW Pharma, for all quantities of Licensed Product on a Licensed Product-by-Licensed Product

basis prior to the emergence of a Branded Competitive Product or a Generic Competitive Product in the Territory, an amount equal to the greater of (a) *** percent (***%) of *** or (b) *** (in each case, the “ Supply Compensation ”). For any period in which Net Sales of a Licensed Product occurs, Supply Compensation shall be calculated as follows:

(a) At least one hundred twenty (120) days prior to the anticipated commercial launch of a Licensed Product, Otsuka shall, in consultation with GW Pharma, establish an initial tentative average unit price for one Unit of each Unit Size of such Licensed Product which, when multiplied by the total quantity of such Unit Size sold by Otsuka in a given period, is reasonably expected to equal *** percent (***%) of Otsuka’s Net Sales for such Unit Size (the “ Tentative Average Unit Price ”). Thereafter, the Tentative Average Unit Price may be revised annually by Otsuka in consultation with GW Pharma for any or all Unit Sizes based upon actual Net Sales for such Unit Size arising during the twelve (12) month period ending on September 30 of the previous calendar year — in order to maintain the Tentative Average Unit Price for each Unit of such Unit Size as reasonably close to *** percent (***%) of Net Sales for one Unit of such Unit Size as practicable — at least thirty (30) days (or some other period agreeable to the Parties) prior to the beginning of each calendar year in respect of each Unit Size of Licensed Product being sold in the Territory. GW Pharma shall invoice Otsuka upon shipment of Licensed Product at the Tentative Average Unit Price for each Unit Size of a Licensed Product multiplied by quantities of such Unit Size contained in such shipment during the calendar year to which such Tentative Average Unit Price applies.

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(b) Within forty-five (45) days following the end of a calendar year in which commercial sales of a Licensed Product have occurred in the Territory, GW Pharma shall calculate the Average Minimum Price for each relevant Unit Size of Licensed Product manufactured during the previous calendar year and report the same to Otsuka subject to the right of Otsuka to audit the calculation of the Average Minimum Price in accordance with Section 5.4 and of the amounts and calculations used in such determination. Within fifteen (15) days from the end of such forty-five (45) day period, Otsuka shall (i) calculate an average Unit Size price for one Unit of each relevant Unit Size equal to *** percent (***%) of its actual Net Sales price during the previous calendar year for such Unit Size (the “ Average Unit Size Price ”), (ii) compare the Average Unit Size Price for each Unit Size obtained under (i) above with the Average Minimum Price applicable to the same Unit Size and (iii) report the same to GW Pharma. If the Average Unit Size Price for any Unit Size obtained under (i) above is greater than the Average Minimum Price for the same Unit Size obtained by GW Pharma as described above, the Parties shall then compare the Average Unit Size Price for such Unit Size with the Tentative Average Unit Price paid by Otsuka in respect of such Unit Size during the previous calendar year. If the Average Unit Size Price of any Unit Size obtained under (i) above is greater than the Tentative Average Unit Price of such Unit Size paid by Otsuka during the previous calendar year, then Otsuka shall pay to GW Pharma an amount equal to the difference between the Average Unit Size Price and the Tentative Average Unit Price for such Unit Size multiplied by the quantity of such Unit Size shipped to Otsuka during the previous calendar year in accordance with the procedure set forth below. If the Average Unit Size Price of any Unit Size obtained under (i) above is less

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than the Tentative Average Unit Price for the Unit Size paid by Otsuka during the previous calendar year, then GW shall pay to Otsuka an amount equal to the difference between the Tentative Average Unit Price and the Average Unit Size Price for such Unit multiplied by the quantity of such Unit Size shipped to Otsuka during the previous calendar year in accordance with the procedure set forth below. If the Average Unit Size Price for any Unit Size obtained under (i) above is less than the Average Minimum Price for the same Unit Size obtained by GW Pharma as described above, the parties shall then compare such Average Minimum Price with the Tentative Average Unit Price paid by Otsuka in respect of such Unit Size during the previous calendar year. If such Average Minimum Price is greater than such Tentative Average Unit Price, then Otsuka shall pay to GW Pharma an amount equal to the difference between such Average Minimum Price and such Tentative Average Unit Price multiplied by the quantity of such Unit Size shipped to Otsuka during the previous calendar year in accordance with the procedure set forth below. If such Average Minimum Price is less than such Tentative Average Unit Price, then GW Pharma shall pay to Otsuka an amount equal to the difference between such Average Minimum Price and such Tentative Average Unit Price multiplied by the quantity of such Unit Size shipped to Otsuka during the previous calendar year in accordance with the procedure set forth below. For purposes of this Section 4.4(b) the Party to whom payment is due shall issue an invoice in respect of the amount to which it is due and shall submit the same to the indebted Party which shall pay such amount within thirty (30) days of receipt of invoice. The “ Average Minimum Price ” for one Unit of each Unit Size of a Licensed Product supplied to Otsuka for commercial sale shall be GW Pharma’s Fully Burdened Cost for all quantities of such Unit Size produced during the applicable period converted to the Fully Burdened Cost for one Unit of such Unit Size up to *** percent (***%); provided, however, if GW Pharma’s Fully Burdened Cost for such vial

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exceeds $***, on notice from GW Pharma to Otsuka of such occurrence, the Parties shall meet and negotiate in good faith to agree upon a revised Average Minimum Price, but not more frequently than annually. Similarly, the Parties shall meet and negotiate in good faith the Average Minimum Price for every other Unit Size, using as a guideline the Average Minimum Price established for the 5.5 ml vial. Subject to the provisions of Section 4.5, upon each shipment of Licensed Product to Otsuka, GW Pharma shall submit an invoice to Otsuka for quantities of Licensed Product actually shipped. Otsuka shall pay each invoice in full within sixty (60) calendar days after the date of invoice. All invoices shall be stated in Dollars and payments shall be made in Dollars. Pricing of clinical samples and promotional samples shall be as set forth in Section 4.5 below.

(c) Within sixty (60) days following the end of each calendar year in which Net Sales of a Licensed Product have occurred, Otsuka shall submit to GW Pharma for each Unit Size of each Licensed Product the following information:

(i) a stock reconciliation detailing the number of Units of each Unit Size brought forward from the previous calendar year, the number purchased in the year, the number sold in the year and any other stock movements (such as but not limited to: returns; expires) and the number carried forward into the new calendar year;

(ii) a reconciliation of the gross amount invoiced by Otsuka, its Affiliates and sublicensees for all sales of the Licensed Product in the relevant calendar year to the total Net Sales for the same calendar year; and

(iii) the calculation of the Net Sales price referenced in sub-sub-section (b) above.

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4.5 Samples. GW Pharma shall supply to Otsuka on the terms of the Manufacture and Supply Agreement (i) Licensed Products and placebo packaged and in final dosage form for use in clinical studies (including, without limitation, investigator sponsored studies) (“Clinical Samples”) free of charge and (ii) promotional samples of each Licensed Product for use in support of commercialization (“Promotional Samples”) of up to ***, or their equivalent, during the term of this Agreement, at the Direct Cost of GW Pharma subject to the following conditions:

(a) In any twelve (12) month period following launch of the Licensed Product in question the amount of Promotional Samples to be supplied at Direct Cost shall not exceed an amount equivalent to *** Promotional Samples per physician detail/call made by Otsuka. If Otsuka uses more Promotional Samples than this in any such year Otsuka shall pay for such additional Promotional Samples at GW Pharma’s Fully Burdened Cost therefor.

(b) Otsuka will provide to GW Pharma via the JCC a rolling annual forecast of Otsuka’s Promotional Sample requirements and orders for Promotional Samples will be confirmed and placed by Otsuka twelve (12) months in advance in the case of orders for Promotional Samples for use in the first twelve (12) month period post-launch of the Licensed Product in question, and six (6) months in advance in the case of orders for Promotional Samples for subsequent twelve (12) month periods. GW Pharma will invoice Otsuka for all such orders upon delivery at Direct Cost and Otsuka shall pay such invoices within thirty (30) days of the date thereof.

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(c) Otsuka will within sixty (60) days following the close of the twelve (12) month period post-launch of Licensed Product report to GW Pharma the number of physician details/calls made in that twelve (12) month period and the total number of Promotional Samples left with such physicians. If such number exceeds an average ***Promotional Samples per detail/call, GW Pharma shall be entitled to invoice Otsuka in relation to such excess amount the sum that is the difference between Direct Cost and Fully Burdened Cost and Otsuka shall pay such invoice within thirty (30) days of the date thereof.

In this Section 4.5 “ Direct Cost ” shall mean the direct cost of manufacturing Promotional Samples limited to direct labor and material costs and quality assurance and quality control costs, including all charges of Third Parties for the manufacture of Promotional Samples, together with costs for transportation, insurance, customs clearance, and storage requested by Otsuka, if any. GW Pharma shall supply to Otsuka Promotional Samples in excess of such *** vials at a price equal to GW Pharma’s Fully Burdened Cost therefor.

4.6 Manufacturing Terms and Conditions. All terms and conditions pertaining to the manufacture and supply of Licensed Products by GW Pharma to Otsuka for use in clinical studies, for distribution as Promotional Samples and for commercial sale, other than as may be expressly set forth in this Agreement, shall be negotiated in good faith by the Parties and set forth in a Manufacturing and Supply Agreement within one hundred eighty (180) days of the Closing Date or such longer period as may be agreed between the Parties. It shall not be a breach of this Agreement if there is a failure to conclude the Manufacturing and Supply Agreement within this timescale. The Parties agree that the Licensed Products and their

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component BDSs shall meet the Specifications and shall otherwise comply with all applicable FDA requirements.

4.7 Product Royalty. With respect to actual Net Sales of Licensed Products during the License Term, within sixty (60) days following the close of each calendar quarter, Otsuka shall pay to GW Pharma a product royalty, subject to applicable adjustments, if any, equal to (i) *** percent (***%) of actual Net Sales during such calendar quarter by itself and its sublicensees or (ii) *** percent (***%) of actual Net Sales during such calendar quarter by itself and its sublicensees at any time that there does not exist a Valid Claim which would be infringed by the making, using or selling of such Licensed Product but for the licenses granted pursuant to this Agreement (the “ Product Royalty ”).

4.8 Third Party Licenses . If at any time either Party believes either that it might be desirable to introduce the use of an invention that is the subject of a Third Party patent right into a Development Plan or that it might be necessary to take a license to a Third Party patent right for other reasons such Party shall bring the relevant Third Party patent right to the attention of the other Party by notice in writing. The Parties agree to meet, within thirty (30) days after such written notification, along with their patent counsel and under appropriate conditions to secure privilege, if necessary, to discuss in good faith the Third Party patent rights in question, to resolve whether they agree that such a license is desirable or necessary and, if so, to agree to the timing of seeking such a license and the responsibility for doing so. During such meeting the Parties agree to discuss such facts, opinions and other information as the Parties deem relevant. If at the end of such discussions Otsuka and GW Pharma are unable to reach agreement, then Otsuka shall be free to enter into such a license. In such a

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case in circumstances where the license is necessary because Otsuka, acting reasonably, believes that otherwise the making, use or sale of Licensed Product would likely infringe the relevant Third Party patent rights and that such relevant Third Party patent rights are likely to be found valid and subsisting and it has expressed this view at the meeting previously held, Otsuka shall be entitled to deduct *** percent (***%) of the costs thereof from Product Royalty payments to GW Pharma; provided, however, no such payment of Product Royalty shall be reduced as a result of such deduction below *** percent (***%) of the amount that would have otherwise been paid. Any such amounts not so deducted as a result of the application of the foregoing limitation shall be carried forward and deducted from subsequent payments of Product Royalty until fully absorbed.

4.9 Compulsory Licenses . Should a compulsory license be granted to a Third Party to make, have made, use, sell or import a Licensed Product under the Laws of the Territory, the royalty rate payable by Otsuka on Net Sales of such Licensed Products shall be adjusted to match any lower royalty rate granted to such Third Party with respect to the sales of such Product, and during such periods for which such Third Party has the right to sell under the compulsory license articles that compete with the Licensed Products then offered for sale by or on behalf of Otsuka, its Affiliates or sublicensees.

4.10 Branded Competitive Products and Generic Competitive Products . Upon a determination that a Branded Competitive Product exists in the Territory, the Parties shall promptly meet for the purpose of discussing and agreeing in good faith an aggregate reduction to the Product Royalty and/or Supply Compensation for the affected Licensed Product to the extent merited by such competition. Upon a determination that a Generic

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Competitive Product exists in the Territory, the Product Royalty for the affected Licensed Product shall be eliminated and the Parties shall promptly meet for the purpose of discussing and agreeing in good faith an appropriate reduction to the Supply Compensation for the affected Licensed Product to the extent merited by such generic competition.

4.11 Royalty-Free Sales . No royalties shall be due upon the sale or other transfer among Otsuka or its Affiliates or their respective sublicensees, but in such cases the royalty shall be due and calculated upon Otsuka’s or its Affiliate’s or their respective sublicensees’ Net Sales to the first unaffiliated Third Party in an arm’s length transaction. No royalties shall be payable on the disposition of Licensed Products in arm’s length transactions (a) without consideration (i) as samples (promotion or otherwise), or (ii) as donations (for example, to non-profit institutions or government agencies for a non-commercial purpose); (b) pursuant to “treatment IND”, compassionate use, or other patient care programs, solely to the extent that the consideration, if any, paid to Otsuka or its Affiliates or their respective sublicensees pursuant to any such program is limited to reimbursement to Otsuka or its Affiliates or their respective sublicensees of the costs of manufacturing and providing the Licensed Product; or (c) in connection with the Development Plan (including clinical studies) for such Licensed Product. For clarity, save as set out in (a), (b) and (c) above upon the sale or other disposal of Licensed Product other than in a bona fide arm’s length transaction exclusively for money or upon any use of Licensed Product for purposes which do not result in a disposal of that Licensed Product in consideration of sales revenue customary in the Territory (in this case disposal not including destruction of damaged, defective, or otherwise unsaleable Licensed Products), such other sale, disposal or use shall be deemed to constitute a sale at the relevant open market price in the Territory, or, if that price is not ascertainable, a reasonable price assessed on an arm’s length basis for the goods or services provided in exchange for the supply.

4.12 Milestone Payments . Subject always to Section 5.2, Otsuka shall pay to GW Pharma the following one-time milestone payments upon the achievement of the events specified below, if applicable, following Closing and within ten (10) days of issuance of an invoice therefor by GW Pharma to Otsuka:

(a) ***;

(b) ***;

(d) ***;

(e) ***;

(f) ***;

(g) ***;

(h) ***;

(i) ***; and

(j) ***.

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Otsuka shall report the occurrence of each of the milestone events set out in sub-sections (b) to (j) above to GW Pharma in writing within ten (10) days of its confirmed occurrence. However, in the event that two (2) or more of the milestones listed in subparagraphs (g) to (j) above are earned during one (1) calendar year, Otsuka may elect to defer payment of the second and subsequent to occur milestone in such calendar year until the first anniversary of such events in the succeeding calendar year. Payment for any such milestones earned in a succeeding year may be similarly deferred until the first anniversary of such event in the next succeeding year. The foregoing process shall continue until all such earned milestones have been paid. Each of the milestone payments set forth in this Section 4.12 shall be payable only one (1) time. Should Otsuka elect to defer payment of a milestone as set out above the deferred milestone payment shall accrue interest on the terms set out in Section 5.6 from the date such milestone payment becomes payable until the date on which it is actually paid.

4.13 Invoices . No payment of any type under this Agreement shall be due to GW Pharma without GW Pharma first having submitted an invoice therefor to Otsuka.

ARTICLE 5

PAYMENTS; RECORDS; AUDITS.

5.1 Manner and Place of Payment . All payments hereunder shall be payable in U.S. dollars. With respect to any calendar year, quarter or month, as applicable, whenever conversion from any other currency shall be required in order to calculate Net Sales, Fully Burdened Cost or other amounts hereunder, such conversion shall be made at a rate of exchange based upon the published rates thereof as set forth in the Financial Times and appropriately calculated under IAS in the case of GW Pharma, consistently applied and will

be so certified annually by GW Pharma based upon such conclusions by its independent accountants. All payments owed under this Agreement shall be made by wire transfer to a bank and account designated in writing by the Party entitled to receive such payment, unless otherwise specified in writing by such Party.

5.2 Taxes . All taxes incurred by GW Pharma on payments made under this Agreement, including taxes levied thereon as income to GW Pharma, shall be paid by GW Pharma. The Parties recognize that under Japanese tax law current at the Closing Date all sums due to GW Pharma hereunder can be paid gross without any withholding for tax provided that before Otsuka makes any payment to GW Pharma hereunder it has filed with the Japanese tax authorities the forms set out at Exhibit G. Otsuka agrees to file such forms promptly after receipt of the same duly completed by GW Pharma and before making any payments to GW Pharma hereunder. Otsuka undertakes and agrees that pending any change in the relevant tax law it shall pay all sums to GW Pharma hereunder gross of any withholding tax, subject to the filing and effectiveness of the forms set forth on Exhibit G. Otsuka takes no responsibility for the accuracy or adequacy of such forms. Otsuka further agrees to assist GW Pharma in whatever way is reasonably practicable and customary to claim exemption from such deductions or withholdings under any double taxation or similar agreement or treaty from time to time in force.

5.3 Reports . Otsuka shall prepare and provide reports of Net Sales to GW Pharma within sixty (60) days following the end of each calendar quarter. Each such report shall include in sufficient detail such information as may be necessary to permit confirmation of the accuracy of the royalty payments made for such quarter, together with details and an explanation of each of the deductions taken in calculating Net Sales and the reasons therefor.

As an alternative to such reports, the Parties may agree to meet to discuss such matters with such frequency as they may determine.

5.4 Records and Audits . During the License Term and for a period of three (3) years thereafter, the Parties shall keep complete and accurate records in accordance with GAAP or IAS (as applicable) pertaining to the costs related to development, manufacture, sale or other disposition of Licensed Products hereunder for the preceding three (3) years. Each Party shall have the right to cause an independent, certified public accountant and associated with an independent accounting firm reasonably acceptable to the other Party to audit such records to confirm Actual Costs, Average Minimum Price Net Sales (in this case including an audit of each of the deductions taken in calculating Net Sales), royalties and other payments for a period covering not more than the preceding three (3) years. Such audits may be exercised during normal business hours upon reasonable prior written notice to the audited Party. The accounting firm shall enter into appropriate obligations of confidence with the audited Party to treat all information it receives during its inspection in confidence. The accounting firm shall disclose to the auditing Party only whether audited reports of costs or royalties are correct and details concerning any discrepancies, but no other information shall be disclosed to the auditing Party. Prompt adjustments shall be made by the Parties to reflect the results of such audit. The initiating Party shall bear the full cost of such audit unless such audit discloses a variance of more than *** percent (***%) from the amount of Actual Costs, Net Sales or royalties or other payments due to the auditing Party under this Agreement, in which event the audited Party shall bear the full cost of such audit. If any such audit reveals any underpayment or overpayment, the Parties shall promptly reconcile any such underpayment or overpayment.

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5.5 VAT . All payments to GW Pharma under the terms of the Agreement are expressed to be exclusive of value added or other sales tax howsoever arising and Otsuka or any sub-licensee Affiliate of Otsuka shall pay to GW Pharma in addition to those payments all value added or other sales tax, if any, for which GW Pharma is liable to account to the applicable tax authority, as a result of the assignment or sub-license of this Agreement to an Otsuka Affiliate domiciled in the European Union, in relation to any supply made or deemed to be made for value added or other sales tax purposes to this Agreement on receipt of a tax invoice or invoices from GW Pharma, subject to the right of Otsuka to dispute the same in good faith.

5.6 Interest . If Otsuka fails to make any payment due to Pharma hereunder on the due date for payment and the payment is not in dispute between the Parties (including if Otsuka elects to defer the payment of a milestone pursuant to Section 4.12), or the dispute has not been resolved, without prejudice to any other right or remedy available to GW Pharma, GW Pharma shall be entitled to charge Otsuka interest (both before and after judgment) on the amount unpaid at the annual rate of *** calculated on a daily basis provided always that this rate of interest is permissible under the law of England and Wales until payment in full is made without prejudice to GW Pharma’s right to receive payment on the due date.

ARTICLE 6

CONFIDENTIALITY.

6.1 Confidentiality . During the License Term and for a period of five (5) years thereafter, each Party hereto will maintain in confidence all Confidential Information

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disclosed to it by the other Party hereto, whether pursuant to this Agreement or otherwise. Neither Party will use, disclose or grant use of such Confidential Information except as expressly authorized by, or expressly contemplated by the licenses granted under, this Agreement. This Agreement contemplates disclosure to the employees, agents, contractors and consultants of each Party. In each such case the disclosing Party will obtain prior written agreement from its employees, agents, contractors or consultants to whom disclosure is to be made to hold in confidence and not make use of such information for any purpose other than those permitted by this Agreement. Each Party will use at least the same standard of care as it uses to protect its own Confidential Information to ensure that such employees, agents, contractors or consultants do not disclose or make any unauthorized use of such Confidential Information. Each Party shall remain responsible for breaches of the confidentiality and non-use provisions of this Agreement by its employees, agents, contractors and consultants. Each Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Confidential Information. Notwithstanding the foregoing to the contrary, a Party may disclose to its Affiliates Confidential Information received from the other Party and such Affiliates may disclose such Confidential Information on a need to know basis to their employees, agents, contractors and consultants under prior written agreements of confidentiality and non-use consistent with the terms of this Agreement; provided, however, each Party shall remain responsible for breaches of the confidentiality and non-use provisions of this Agreement by its Affiliates and their employees, agents, contractors and consultants.

6.2 Authorized Disclosure . A recipient Party may:

(a) disclose Confidential Information disclosed to it hereunder to the extent such disclosure is reasonably necessary in filing or prosecuting patent applications

in accordance with this Agreement, or prosecuting or defending litigation in accordance with this Agreement;

(b) disclose the Confidential Information disclosed to it hereunder: (i) to the extent such disclosure is reasonably necessary to comply with the order of a court; or (ii) to the extent such disclosure is required to comply with an applicable Law, including to the extent such disclosure is required in publicly filed financial statements or other public statements under rules governing a stock exchange (e.g., the rules of the United States Securities and Exchange Commission, NASDAQ, NYSE, UKLA or any other stock exchange on which securities issued by either Party may be listed); provided, to the extent possible bearing in mind such Law and subject to the next subsequent sentence of this Section 6.2(b), such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure five (5) business days in advance of the date on which the disclosure is to be made to enable the other Party to review and provide comments, unless a shorter review time is agreed. If the compliance with an applicable Law requires filing of this Agreement, the filing Party shall to the extent possible seek confidential treatment of portions of this Agreement from the relevant competent authority and shall provide the other Party with a copy of the proposed filings at least ten (10) business days prior to filing for the other Party to review any such proposed filing. If bearing in mind such Law those consultation periods are not workable the relevant Party shall use reasonable efforts to have some form of consultation with the other Party, as an absolute minimum informing the other Party of the text of any statements or disclosure as long in advance as is practicable before they are made. Each Party agrees that it will obtain its own legal advice with regard to its compliance with such Laws and will not rely on any statements made by the other Party relating to such Laws;

(c) disclose Confidential Information disclosed to it hereunder to a regulatory authority as reasonably necessary to obtain Full Regulatory Approval in a particular jurisdiction to the extent consistent with the licenses granted under terms of this Agreement;

(d) disclose Confidential Information disclosed to it hereunder: (i) to its actual or potential distributors, licensees or sub-licensees; (ii) to its actual or potential investment bankers; (iii) to existing and potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders for the purpose of obtaining financing for its business; and (iv) to a bona fide potential acquirer or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to substantially the same extent as set forth in Section6.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement. Each Party shall remain responsible for breaches of the confidentiality and non-use provisions of this Agreement by any such persons. Each Party will promptly notify the other upon discovery of any unauthorized use or disclosure of the Confidential Information; and

(e) disclose Confidential Information disclosed to it hereunder to its legal and other advisers for the purpose of seeking advice.

6.3 Other than the press releases pertaining to this transaction that the Parties have agreed upon and attached as Exhibit F to this Agreement and save as permitted in Section 6.2:

(a) neither Party shall make any public announcement or statement to the public concerning the terms of this Agreement without the prior written consent of the other, which shall be neither unreasonably withheld or delayed. No such public

announcements or statements shall be made without the prior review and consent of the appropriate individual designated for the purpose by the other Party;

(b) neither Party shall publish or present in a scientific journal or any other scientific setting any data generated under a Development Plan by or for such Party with respect to a Licensed Product, including Pre-Clinical Data, Otsuka Clinical Data or Phase IV Clinical Studies conducted by Otsuka, without providing a copy of such publication or presentation to the JDC at least thirty (30) days prior to submission thereof for publication or presentation and obtaining the JDC’s prior written consent (which may not be unreasonably withheld or delayed). The JDC shall be entitled to delay the publication or presentation in the Territory for up to thirty (30) days to allow the preparation and filing of a patent application relating to an Invention contained in such publication or presentation; and

(c) where GW Pharma can control the same, shall, (i) prior to publication in a scientific journal of any data generated by or for GW Pharma outside the Territory with respect to a Licensed Product, provide a copy of such publication to Otsuka at least thirty (30) days prior to submission by GW Pharma thereof for publication to allow Otsuka to comment on the same and (ii) prior to presentation in any other scientific setting of any data generated by or for GW Pharma outside the Territory with respect to a Licensed Product, provide a copy of such presentation to Otsuka at least fifteen (15) days prior to submission by GW Pharma thereof for presentation to allow Otsuka to comment on the same. If Otsuka has any comments on such publication or presentation provided to it, Otsuka shall send these comments in writing to GW Pharma and GW Pharma shall consider the comments and amend such publication or presentation as it sees fit, acting reasonably.

6.4 Injunctive Relief . The Parties expressly acknowledge and agree that any breach or threatened breach of this Article 6 may cause immediate and irreparable harm to

the disclosing Party that may not be adequately compensated by damages. Each Party therefore agrees that in the event of such breach or threatened breach and in addition to any remedies available at law, the disclosing Party shall have the right to obtain equitable and injunctive relief, without bond, in connection with such a breach or threatened breach.

6.5 Pre-Existing Confidentiality Agreement . The provisions of this Article 6 shall supersede that certain Mutual Confidentiality Agreement entered into as of 16 August, 2006 by and between Otsuka and GW Pharma (the “ Confidentiality Agreement ”) and shall govern the treatment of information disclosed under the Confidentiality Agreement.

ARTICLE 7

INTELLECTUAL PROPERTY RIGHTS.

7.1 Ownership .

(a) Ownership of any inventions made by one or both of the Parties in the conduct of the Development Plan, whether or not patentable (“Inventions”), shall be determined in accordance with U.S. laws of inventorship;

(b) All know-how (other than inventions) of the type within the definitions of GW Pharma Know-How or Otsuka Know-How with the exception of Pre-Clinical Data and arising under the Development Plan or any subsequent commercialization for a Licensed Product shall be owned by the Party generating such know-how and shall become part of GW Pharma Know-How or Otsuka Know-How as the case may be; and

(d) Pre-Clinical Data shall be owned by GW Pharma.

7.2 Patent Prosecution and Maintenance .

(a) GW Pharma shall control, and be responsible for, filing, prosecution, and maintenance and defense of the GW Pharma Patent Rights (other than the Joint Patents (defined below)) (including but not limited to any interference, reissue or re-examination or opposition or revocation proceedings) and GW Pharma shall pay the expenses thereof. GW Pharma shall be responsible for the filing, prosecution, maintenance and defense of patent rights claiming any Invention owned jointly by the Parties (the “ Joint Patents ”) (including but not limited to any interference, reissue or re-examination or opposition or revocation proceedings), and the Parties shall share equally in the expenses thereof. Otsuka shall control, and be responsible for, filing, prosecution, maintenance and defense of Otsuka Patent Rights other than Joint Patents (including but not limited to any interference, reissue or re-examination or opposition or revocation proceedings), at Otsuka’s sole expense. GW Pharma and Otsuka and their nominated patent attorneys shall regularly meet and confer regarding strategies for the filing, prosecution and defense of GW Pharma Patent Rights (including Joint Patents), and Otsuka Patent Rights (excluding Joint Patents) and proposed responses to official actions. Each Party shall consider in good faith and give due regard to the requests and suggestions of the other with respect to strategies for prosecuting the GW Pharma Patent Rights, Joint Patents and Otsuka Patent Rights (as applicable). Each Party shall keep the other informed of progress with regard to the prosecution, maintenance and defense of GW Pharma Patent Rights, Joint Patents and Otsuka Patent Rights (as applicable) by providing the other with copies of official actions, amendments and responses with respect to such prosecution within seven (7) days of receipt of such notices.

(b) In the event that GW Pharma desires to abandon any GW Pharma Patent Rights other than Joint Patents in the Territory, GW Pharma shall provide prior written notice to Otsuka of such intention to abandon as soon as is reasonably practicable under the circumstances, but not less than thirty (30) days prior to the date of abandonment, and Otsuka shall have the right, at its expense, to prepare, file, prosecute and maintain such GW Pharma Patent Rights, as applicable. GW Pharma shall execute such documents and perform such acts as may be reasonably necessary for Otsuka to prepare, file, prosecute or maintain such GW Pharma Patent Rights. Thereafter, Otsuka shall solely own such GW Pharma Patent Rights, as the case may be, in their entirety and GW Pharma shall promptly assign its entire interest in such GW Pharma Patent Rights to Otsuka.

(c) In the event that either Party no longer wishes to pay its share of the costs for the prosecution, maintenance and defense of any Joint Patent whether in the Territory or outside the Territory, the withdrawing Party shall give written notice to the other of such intention and in the case that this is GW Pharma and Otsuka shall have the right, at its expense, to prepare, file, prosecute and maintain such Joint Patents thereafter, as applicable. In such a case GW Pharma shall execute such documents and perform such acts as may be reasonably necessary for Otsuka to prepare, file, prosecute or maintain such Joint Patents. In either case the Party that has decided not to contribute financially any longer shall assign its entire right, title and interest in and to the Joint Patents in the relevant country to the other Party.

(d) In the event that Otsuka desires to abandon any Otsuka Patent Rights that are Otsuka Sole Patents in the Territory, Otsuka shall provide prior written notice to GW Pharma of such intention to abandon as soon as is reasonably practicable under the circumstances, but not less than thirty (30) days prior to the date of abandonment, and GW

Pharma shall have the right, at its expense, to prepare, file, prosecute and maintain such Otsuka Patent Rights. Otsuka shall execute such documents and perform such acts as may be reasonably necessary for GW Pharma to prepare, file, prosecute or maintain such Otsuka Patent Rights. Thereafter, GW Pharma shall solely own such Otsuka Patent Rights and Otsuka shall promptly assign its entire interest in such Otsuka Patent Rights to GW Pharma. Otsuka shall have a non-exclusive fully paid-up irrevocable license to practice and otherwise exploit the inventions claimed or issued in such Otsuka Patent Rights in any way whatsoever, but not in relation to the development, making, having made, selling, offering for sale or otherwise exploiting Licensed Products in the Territory. The foregoing non-exclusive license shall arise only under and on the terms of this Agreement as if such Otsuka Patent Rights had become GW Pharma Patent Rights.

7.3 Infringement by Third Parties . Each of GW Pharma and Otsuka shall promptly notify the other in writing of any alleged or threatened infringement or any challenge to the validity of any GW Pharma Patent Rights or Otsuka Patent Rights in the Territory or any challenge to GW Pharma’s ownership of, or Otsuka’ right to use, the GW Pharma Patent Rights in the Territory of which they become aware. Challenges to the validity of GW Pharma Patent Rights (including Joint Patents) will be dealt with by GW Pharma in accordance with the provisions of Section 7.2(a). Challenges to the validity of Otsuka Patent Rights will be dealt with by Otsuka in accordance with the provisions of Section 7.2(a). Both Parties shall use their commercially reasonable efforts in cooperating with each other to terminate any infringement without litigation. GW Pharma shall have the first right, at its expense, to bring and control any action or proceeding with respect to infringement of any GW Pharma Patent Rights in the Field including any counterclaim for invalidity or unenforceability or any declaratory judgment action in the Territory by counsel of its own choice, and Otsuka shall have the right, at its own expense, to be represented in

any such action by counsel of its own choice. Otsuka shall have the right, but not the obligation, at its expense to bring and control any action or proceedings with respect to infringement of any Otsuka Patent Rights in the Territory. If GW Pharma fails to bring an action or proceeding with respect to infringement of any GW Pharma Patent Rights in the Field in the Territory within (a) sixty (60) days following the notice of alleged infringement or (b) thirty (30) days before the time limit, if any, set forth in the appropriate Laws and regulations for the filing of such actions, whichever comes first, Otsuka shall have the right to bring and control any such action at its own expense and by counsel of its own choice and shall have the right to join GW Pharma as a co-plaintiff if GW Pharma is a necessary party, as advised by Otsuka’s counsel, at Otsuka’s cost and expense. GW Pharma shall also have the right, at its own expense, to be represented in any such action by counsel of its own choice. In the event a Party brings an infringement action regarding GW Pharma Patent Rights, the other Party shall cooperate fully with the Party bringing such action. Neither Party shall have the right to settle any infringement litigation under this Section 7.3. regarding an infringement of any GW Pharma Patent Rights in the Territory in the Field without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. For clarity, this means that if Otsuka has conduct of any action it shall not settle any counter-claim for invalidity of a GW Pharma Patent Right (including a Joint Patent) without the prior consent of GW Pharma. Except as otherwise agreed to by the Parties as part of a cost-sharing arrangement, any recovery realized as a result of such litigation shall first be applied to reimbursement of the Party first bringing such litigation, then to reimbursement of a Party joining such litigation, and finally any amount remaining shall be shared between the Parties with Otsuka retaining *** percent (***%) thereof and GW Pharma retaining *** percent (***%) thereof.

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7.4 Infringement of Third Party Rights .

(a) Each Party shall promptly notify the other in writing of any written allegation or claim by a Third Party that one or more activities of either of the Parties pursuant to this Agreement or the Manufacturing and Supply Agreement in relation to the Territory infringes or may infringe the intellectual property rights of such Third Party. Prior to the commencement of proceedings by any such Third Party each Party shall, in close consultation and liaison with the other, be responsible for responding to the Third Party on their own behalf.

(b) Subject to Section 7.4(c), GW Pharma shall have the right, but not the obligation, to defend at its own expense and by counsel of its own choice any claim involving alleged infringement of Third Party patent rights by GW Pharma’s activities inside and/or outside the Territory. If such claim alleges that the development, manufacture, use, offer for sale or sale of any Licensed Product in the Territory infringes such Third Party’s patent rights, Otsuka shall have the right, at its own expense, to be represented in any such action by counsel of its own choice, and if GW Pharma does not defend against such claim, then Otsuka may assume such defense at its expense and using counsel of its own choice, in which case Otsuka’s unreimbursed direct costs of defense will be credited against subsequent Product Royalties, such credit amounts for any period not to exceed ***% of the Product Royalties due for such period.

(c) If any such allegation or claim results in proceedings being brought by such Third Party and the proceedings are in the Territory, Otsuka shall have the first right, but not the obligation, to defend at its own expense and by counsel of its own

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choice any proceedings involving alleged infringement of such Third Party patent rights by Otsuka’s or GW Pharma activities. GW Pharma shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. *** percent (***%) of Otsuka’s unreimbursed direct costs for its defense of such claim will be credited against subsequent Product Royalties, such credit amounts for any period not to exceed ***% of the Product Royalties due for such period. If any such credit amounts are unabsorbed in a given period, the balance shall be carried forward to the next and subsequent periods as necessary until they have been fully absorbed. If Otsuka does not defend against any such claim, then GW Pharma may assume such defense at its expense and using counsel of its own choice and in this case Otsuka shall reimburse to GW Pharma *** percent (***%) of GW Pharma’s unreimbursed direct costs for its defense of such claim.

(d) Each Party shall keep the other Party fully informed with regard to the defense of claims brought by Third Parties covered by this Section 7.4(d). Neither Party shall have the right to settle any such claim covered by Section 7.4(b) or 7.4(c) without the written consent of such other Party, which consent shall not be unreasonably withheld or delayed. Otsuka and GW Pharma shall share the cost of any monetary judgment obtained by a Third Party claiming infringement of such a claim with GW Pharma bearing *** percent (***%) of any such amounts and Otsuka bearing *** percent (***%) of any such amounts. Otsuka shall be entitled to deduct *** percent (***%) of the costs thereof from Product Royalty payments to GW Pharma; provided, however, no such payment of Product Royalty shall be reduced as a result of such deduction below *** percent (***%) of the amount that would have otherwise been paid. Any such amounts not so deducted as a result

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of the application of the foregoing limitation shall be carried forward and deducted from subsequent payments of Product Royalty until fully absorbed.

7.5 Trademark Provisions .

(a) In the event that a pending application to register a Licensed Trademark is disallowed or should a Licensed Trademark come to be no longer registered to GW Pharma, GW Pharma shall provide Otsuka with prompt written notice thereof, Otsuka shall promptly cease using such Trademark and the Parties shall choose an alternative trademark for use with the Licensed Products, whereupon such alternative trademark shall be deemed included in the definition of Licensed Trademarks for purposes of this Agreement.

(b) GW Pharma shall retain full and complete ownership and control of the Licensed Trademarks and the goodwill relating thereto during the License Term. Otsuka agrees that nothing contained in this Agreement shall vest or otherwise transfer, convey or give to Otsuka any right, title or interest in the Licensed Trademarks not expressly provided in this Agreement. Otsuka acknowledges and agrees that all use of the Licensed Trademarks by Otsuka, and its sublicensees, and all goodwill generated under this Agreement, shall inure to the sole legal benefit of the registered owner of the Licensed Trademarks and all rights derived, or that may be derived by Otsuka, and its sublicensees, from the use of the Licensed Trademarks hereby permitted within the Territory shall belong to such registered owner.

(c) Otsuka and its sublicensees shall use the Licensed Trademarks in such form and manner as currently used by GW Pharma as of the Closing Date or in such other form and manner as may be approved in writing by GW Pharma from time to time during the term of the License Term. Otsuka shall notify GW Pharma in writing of any desired change in the form of the Licensed Trademarks and request GW Pharma’s approval

thereof, submitting with its request specimens of the proposed change. GW Pharma will be deemed to have approved the changed form of the Licensed Trademark(s) unless it shall have rejected such changed form in writing within thirty (30) days of receipt of such request. GW Pharma shall consider in good faith Otsuka’ suggestions regarding changes to the Licensed Trademarks and proposed additional Licensed Trademarks. If at any time the Parties should decide to use substitute trademarks or to establish other trademarks for use in connection with the Licensed Products, all such trademarks shall be owned by GW Pharma. Otsuka shall assign its interest, as it may exist, in any such trademarks to GW Pharma at no cost to GW Pharma.

(d) Otsuka and its sublicensees shall not use the Licensed Trademarks in combination or in conjunction, or as part of, any other service marks or trademarks and shall ensure that any such use of the Licensed Trademarks is accompanied by an acknowledgement that the Licensed Trademark in question is owned by GW Pharma and used by Otsuka or its sub-licensee under license. Subject to Section 7.5(f), Otsuka and its sublicensees may use their respective trade names without the prior approval of GW Pharma, in connection with the advertising, packaging and labeling of the Licensed Products so long as such use is materially in accordance with all applicable Laws and regulations in the Territory. Otsuka agrees, and will require its sublicensees to agree, not to use the Licensed Trademarks in any manner save as approved pursuant to Section 7.5(f).

(e) At such time as Otsuka may have the right to manufacture, or have manufactured, Licensed Products, Otsuka hereby undertakes to manufacture, and shall require its sublicensees to agree, to manufacture Licensed Products, if at all, consistent with the maintenance of the image of the Licensed Products and in accordance with applicable laws including, but not limited to, regulations of the FDA. In connection therewith, GW

Pharma or its authorized representative shall have the right, during regular business hours upon reasonable advance written notice to Otsuka, to inspect the Licensed Products manufactured by Otsuka or its designee in the form of finished goods in relation to which the Licensed Trademarks are to be used, as well as the methods of manufacturing such goods, as reasonably necessary to ascertain whether such Licensed Products meet appropriate quality control standards (as set forth in a separate written agreement between the Parties or communicated to Otsuka in writing). GW Pharma shall also have the right to receive from time to time, without charge, a reasonable number of samples of such finished goods for the sole purpose of monitoring Otsuka’s compliance with its obligations hereunder.

(f) Otsuka shall submit to GW Pharma for approval in writing, representative samples of all packages, labels, advertising and other materials to use in commercializing Licensed Products and/or on which the Licensed Trademarks appears, including the trade dress for each Licensed Product, (other than any of the foregoing produced by GW Pharma, its Affiliates or their respective designees) which approval shall not be unreasonably withheld. GW Pharma agrees to review any such packaging, labels, advertising and other materials provided by Otsuka hereunder, and to notify Otsuka whether GW Pharma approves the same, within ten (10) business days of receipt thereof. Otsuka as the holder of the FDA Regulatory Approvals for Licensed Products shall have the final decision making power regarding the trade dress and other packaging, labeling, advertising and other materials relating to commercialization of Licensed Product or bearing the Licensed Trademarks.

(g) Subject to Section7.5(f), the initial trade dress for each Licensed Product for each indication shall be proposed by Otsuka. GW Pharma shall implement such trade dress on the following terms:

(i) Otsuka shall supply GW Pharma with full details of the trade dress for each Licensed Product and if the cost and expense of printing packaging with such trade dress is greater than the cost and expense of the printing process currently used by or on behalf of GW Pharma for the trade dress outside the Territory, GW Pharma shall, within sixty (60) days of receipt of details of such trade dress, advise Otsuka in writing of such additional cost and expense relating to preparing and printing such trade dress specified as a Fully Burdened Cost per package;

(ii) if Otsuka decides to proceed, GW Pharma shall be responsible for commissioning and acquiring all related artwork, plates and other materials necessary to print the packaging in such trade dress; and

(iii) the additional Fully Burdened Cost identified by GW Pharma shall be added to the Supply Compensation of the applicable Licensed Product.

(h) GW Pharma shall be responsible for prosecuting and maintaining the Licensed Trademarks, including the payment of all costs and fees associated with such prosecution and maintenance. GW Pharma shall keep Otsuka fully informed of all material matters pertaining to the prosecution and maintenance of the Licensed Trademarks and shall seek the views of Otsuka with regard to such matters and give such views of Otsuka due regard when prosecuting and maintaining the Licensed Trademarks.

(i) Otsuka agrees to notify GW Pharma promptly in the event it becomes aware that any Licensed Trademark is being infringed or adversely affected by the use of Third Parties in the Territory, and further agrees to take no action of any kind with respect thereto except in accordance with this Agreement. GW Pharma shall have the right, in its sole discretion, to take whatever steps it deems necessary or desirable to protect the Licensed Trademarks from any such infringement or other adverse use and shall have the

right to control any litigation or other proceeding undertaken by it for any such purpose. Otsuka agrees to cooperate with GW Pharma, at GW Pharma’ expense, in the event such action entails litigation or other similar proceedings. In the event that GW Pharma or any of its Affiliates brings any such action, GW Pharma agrees to consider, and to cause its Affiliate(s) to consider, in good faith the reasonable suggestions of Otsuka regarding such action. In the event GW Pharma declines to take action with respect to a particular infringement or adverse use it shall promptly notify Otsuka in writing, and Otsuka shall have the option of taking such action as it deems appropriate. Otsuka shall have the sole responsibility for whatever action it takes, and GW Pharma agrees to cooperate fully with Otsuka, at Otsuka’ expense.

(j) GW Pharma agrees to indemnify Otsuka, its Affiliates and sublicensees, against all damages resulting from any claim of trademark infringement or dilution brought against Otsuka by Third Parties arising out of the authorized use of the Licensed Trademarks by Otsuka, and its sublicensees, under the terms of this Agreement, except to the extent due to the negligence or willful misconduct of any such indemnified party or parties, and provided that Otsuka, its Affiliates and sublicensees have complied in all material respects with all of their obligations under Section 7.5. In the event, Otsuka, or its sublicensees are named as defendants in an action for which GW Pharma has an obligation to indemnify under this Section 7.5, Otsuka agrees to promptly notify GW Pharma, and GW Pharma shall have the right to intervene in any such action and to control and direct the defense thereof, including the right to select defense counsel. In the event GW Pharma chooses to exercise control, it agrees to reimburse Otsuka and its sublicensees for the out-of-pocket costs of their defense incurred prior to the assumption of defense.

(k) Neither Party shall mention or otherwise use any trademark of the other Party or its Affiliates, other than the Trademarks as provided under this Agreement, in any publication, press release, promotional material or other form of publicity without the prior written consent of the appropriate individual designated for the purpose by the other Party.

ARTICLE 8

REGULATORY MATTERS.

8.1 Regulatory Activities .

(a) Although the provisions of this Agreement require the INDs for the development of Licensed Product to be held by GW Pharma until the NDA for Licensed Product for the First Indication is first filed by Otsuka and the NDAs and Full Regulatory Approvals in respect of Licensed Products are to be held by Otsuka, it is a fundamental principle of this Agreement that the content of all material written documents, communications, submissions, calls (as may be reasonably practicable), conferences and meetings with the FDA or DEA is discussed between the Parties in close consultation including at the relevant JDC sub-committee and, if appropriate, at the JDC itself before any of the same are made by GW Pharma or Otsuka, whether or not the other Party otherwise participates in any of the same.

(b) In relation to the development and commercialization of Licensed Product prior to the filing by Otsuka of the NDA for Licensed Product for the First Indication:-

(i) GW Pharma shall be responsible for the design of the protocol and for the conduct of all clinical studies required for the filing of an NDA and as set out in the First Indication Development Plan, in close consultation with Otsuka as described in Section 8.1(a). Otsuka shall be responsible for the design of the protocol and for the conduct of Phase IIIb Clinical Studies, Phase IV Clinical Studies for the First Indication and for all clinical studies set out in the Second Indication Development Plan or other Development Plans in close consultation with GW Pharma as described in Section 8.1(a);

(ii) As GW Pharma is a foreign drug establishment it hereby appoints Otsuka as of the Closing (which appointment may be delegated by Otsuka to an Affiliate of Otsuka) as its agent under 21 C.F.R, §312.23 to sign relevant documents and to facilitate communications between GW Pharma and the FDA relating to any IND. In this respect Otsuka shall be responsible for arranging all meetings and calls with the FDA but at times convenient for GW Pharma when reasonably practicable. The agency relationship established under this Section8.1(ii) shall continue for so long as Otsuka is fulfilling its obligations as GW Pharma’s IND agent, otherwise GW Pharma may terminate Otsuka’s appointment as its agent by giving written notice and appoint an alternative Third Party as its agent in respect of the INDs. For clarity, GW Pharma’s obligations of consultation under Section 8.1(a) apply regardless of whether Otsuka is then acting as the IND agent of GW Pharma. The termination of Otsuka by GW Pharma as its IND agent shall have no consequence under this Agreement other than terminating such status. Such termination shall not be deemed to cause, or to have resulted from, a breach of this Agreement.

(iii) With respect to the First Indication, but only before the filing by Otsuka of an NDA with respect thereto, GW Pharma shall be responsible for any IND covering Licensed Product filing on its own letterhead and signed by it, but also signed

by Otsuka as its agent under Section 8.1(b)(ii) as appropriate and having consulted with Otsuka as described in Section 8.1(a) with Otsuka having had the opportunity to see and comment on the draft filing and having prepared an electronic copy of the same at its own cost and expense and GW Pharma having, acting reasonably, reflected such comments in the filing so far as GW Pharma thinks fit to do so;

(iv) GW Pharma shall be responsible for all other communications with FDA whether oral or written and whether on calls, in conferences or at meetings concerning an IND covering Licensed Product in the case of written communication on its letterhead and in its own name signed by it and by Otsuka its agent under Section 8.1(b)(ii) and in the case of oral communication by personal representation provided that:

(x) Otsuka has first seen and commented on drafts of all written communications or suggested scripts for oral communications, as may be reasonably practicable, and GW Pharma, acting reasonably, reflects any comments of Otsuka so far as GW Pharma thinks fit to do so;

(y) Otsuka has the right to have at least one (1) representative present in any such calls, conferences or meetings, as may be reasonably practicable and to the extent permitted by FDA.

(z) GW Pharma shall in close consultation with Otsuka under Section 8.1(a) be responsible for dealing with DEA in relation to all DEA Regulatory Approvals;

(c) Once Otsuka is ready to file and/or has filed the NDA for Licensed Product for the First Indication and GW Pharma has transferred to Otsuka all other INDs covering Licensed Product under Section 3.4(b):

(i) Otsuka shall be responsible for any IND or NDA filing on its own letterhead and signed by it, but having consulted with GW Pharma as described in

Section 8.1(a) with Otsuka having drafted the filing and made an electronic form of the same at its own cost and expense, such draft having been given to GW Pharma so that it has an opportunity to comment upon the same, as may be reasonably practicable, and Otsuka shall, acting reasonably, reflect such comments in the draft filing so far as Otsuka thinks fit to do so;

(ii) Otsuka shall be responsible for all other communications with FDA whether oral or written and whether on calls, in conferences or at meetings concerning any IND, NDA or FDA Regulatory Approval in the case of written communication on its letterhead and in its own name and having consulted with GW Pharma in accordance with Section 8.1(a) and in the case of oral communication by personal representation provided that:

(x) GW Pharma has first seen and commented on drafts of all written communications or suggested scripts for oral communications, as may be reasonably practicable, and Otsuka, acting reasonably, reflects any comments of GW Pharma so far as Otsuka thinks fit to do so;

(y) GW Pharma has the right to have at least one (1) representative present in any such calls, conferences or meetings, as may be reasonably practicable and to the extent permitted by FDA.

(iii) Otsuka shall in close consultation with GW Pharma under Section 8.1(a) be responsible for dealing with the DEA in relation to all DEA Regulatory Approvals.

(d) In relation to all Licensed Products Otsuka shall only commercialize the same in a manner consistent with their then current labeling.

(e) Promptly following the Closing or such longer period as the Parties shall agree the Parties shall in good faith negotiate and enter into a separate agreement in respect of their detailed pharmacoviligance obligations which shall be consistent with all applicable laws and International Committee for Harmonization guidelines (the “ Pharmacovigilence Agreement ”). It shall not be a breach of this Agreement if the Parties fail to enter into the Pharmacovigilence Agreement within this timescale. The Pharmacovigilence Agreement shall establish in sufficient detail an appropriate procedure to ensure that all pharmacovigilance requirements are met. The procedure shall be based on full mutual transparency, internationally acceptable quality of pharmacovigilance operations in the exchange of the safety information of the Licensed Products in a timely manner. Further, the procedure shall be based on the pharmacovigilance concept that Otsuka shall be responsible for collecting safety information on the Licensed Products in the Territory and GW Pharma for collecting such information outside the Territory. The Parties shall provide safety information to each other as may be necessary for each such Party to fulfill the reporting requirements in its respective territory within the required time periods so as to enable such Party to meet its regulatory requirements.

(f) Otsuka shall maintain copies of all documents submitted to and received from the FDA or DEA relating to a Licensed Product at no cost to GW Pharma.

(g) Otsuka shall, within ten (10) business days, forward to such person at GW Pharma identified to Otsuka in writing by GW Pharma copies of all communications received from the FDA and DEA relating to a Licensed Product. Questions of further action raised or required by the FDA or DEA relating to a Licensed Product shall be reviewed by Otsuka with GW Pharma and any response or further action shall be

discussed in advance at the relevant JDC sub-committee unless an earlier response is demanded in the circumstances.

(h) Subject to contractual obligations due to Third Parties, during the License Term, Otsuka shall, at no cost to GW Pharma, provide to GW Pharma data and information related to the Licensed Product Controlled by Otsuka for use by GW Pharma in connection with its obligations to the FDA and DEA. Otsuka shall, in consultation with GW Pharma through the JDC, design and prepare labels, package inserts, packaging, and other materials which will accompany each and every Licensed Product in the form in which it will be sold or distributed in the Territory. Any disputes on the JDC regarding the design and preparation of such labels, package insert, packaging and other associated materials shall be resolved as set out in Section 3.7.

(i) If either GW Pharma or Otsuka becomes aware of any fact, condition, circumstance, or event (whether actual or potential) concerning or related to a Licensed Product that may reasonably require recall or market withdrawal of a Licensed Product or a “Dear Doctor” letter relating to a Licensed Product, such Party shall communicate such fact, condition, circumstance or event promptly to the other Party. In the event (i) any governmental agency or regulatory body issues a request, directive or order that a Licensed Product be recalled; (ii) a court of competent jurisdiction orders that a Licensed Product be recalled; or (iii) the JDC reasonably determines, after consultation, that a Licensed Product should be recalled or withdrawn from the market or that a “Dear Doctor” letter should be sent relating to use of a Licensed Product, the Parties shall take all appropriate remedial actions with respect thereto; provided, however, that Otsuka, in its sole discretion, shall finally determine any recall matters in the Territory. To the extent that it is necessary or appropriate to communicate with any person or entity in the Territory, including but not

limited to any governmental agency or regulatory body, the media or any customer, concerning any such fact, condition, circumstance or event, Otsuka shall be the primary contact concerning remedial action. The Party that is at fault for giving rise to the fact, condition, circumstance or event resulting in the recall or withdrawal of a Licensed Product, as determined by an independent testing laboratory or a mutually acceptable regulatory consultant familiar both with the circumstances and with the allocation of responsibilities between the Parties under this Agreement, shall bear all expense of the recall, the Licensed Product withdrawal, or the “Dear Doctor” letter including the costs of preparation of customer lists and letters, mailing expenses, media notices and other public announcements, and any other necessary notice, destruction or return of the recalled or withdrawn Product, the cost of shipping and freight, and the cost of the recalled or withdrawn Product. If it is determined that the Parties share responsibility, then they shall share such expense in accordance with their allocated percentages of responsibility.

ARTICLE 9

REPRESENTATIONS, WARRANTIES AND ADDITIONAL COVENANTS.

9.1 Mutual Representations, Warranties and Covenants. As of the date of this Agreement above here written and as of the Closing, each Party hereby represents and warrants to, and covenants with, the other Party as follows:

(a) Existence and Power . Such Party (i) is duly organized, validly existing and in good standing under the laws of the state or other jurisdiction in which it is organized; and (ii) is in compliance with all requirements of applicable law, except to the extent that any noncompliance would not materially adversely affect such Party’s ability to perform its obligations under the Agreement.

(b) Authorization and Enforcement of Obligations . Such Party (i) has the power and authority and the legal right to enter into this Agreement and to perform its obligations hereunder and (ii) has taken all necessary action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

(c) No Consents . All necessary consents, approvals and authorizations of all governmental authorities and other persons required to be obtained by such Party in connection with this Agreement have been obtained, except for those which cannot be obtained prior to the filing of the NDAs or grant of the Full Regulatory Approvals.

(d) No Conflict . The execution and delivery of this Agreement and the performance of such Party’s obligations hereunder (i) do not conflict with or violate any law, regulation, order, tax lien or other requirement of any governmental body, court or administrative or other agency having jurisdiction over such Party and (ii) do not conflict with, or constitute a material default or require any consent under, any agreement, instrument or understanding, oral or written, to which it is a Party or by which it may be bound. Neither Party shall enter into any agreement or arrangement with any Third Party that would prevent or in any way interfere with its obligations pursuant to this Agreement and except with respect to any approvals that may be required under the HSR Act.

9.2 Otsuka Representations, Warranties and Covenants . As of the date of this Agreement above here written and as of the Closing, Otsuka represents and warrants to, and covenants with GW Pharma as follows:

(a) That, subject to Sections 10.8(d)(i) and 10.8(d)(ii), it is not itself or through its Affiliates distributing, promoting, offering for sale or selling any potential

or actual Branded Competing Products or any potential or actual Generic Competing Products, and during the License Term, Otsuka will not itself or through its Affiliates distribute, promote, offer for sale or sell potential or actual Branded Competing Products or potential or actual Generic Competing Products in the Territory; provided, however, that during the License Term, Otsuka or its Affiliates may distribute, promote, offer for sale and sell such a potential or actual Branded Competing Product or potential or actual Generic Competing Product that it acquires as part of the acquisition of an entity, business or product line on written notice to GW Pharma to such effect but may not use its direct sales force to distribute, promote, offer for sale or sell such potential or actual Branded Competing Products or potential or actual Generic Competing Products. For clarity, in this Section “potential” refers to the fact that the Net Sales test within the definition of Branded Competing Product or Generic Competing Product has not then been satisfied.

(b) That in the exercise of its rights under this Agreement and the conduct of its business and affairs related thereto, it will comply with all applicable Laws including, but not limited to, the applicable rules, regulations and guidelines of Regulatory Authorities.

9.3 GW Pharma Representations, Warranties and Covenants . As of the date of this Agreement above here written and as of the Closing, GW Pharma represents and warrants to, and covenants with, Otsuka as follows:

(a) GW Pharma has sufficient rights and power to grant the licenses to Otsuka which it purports to grant herein.

(b) GW Pharma knows of no Third Party infringement of the Licensed Intellectual Property or the Licensed Trademarks or misappropriation of the GW Pharma Know-How.

(c) GW Pharma does not believe that the practice of the Licensed Intellectual Property infringes or will infringe any valid claims of Third Party patent right(s) in the Territory or that the use of the Licensed Trademarks infringes or will infringe any trademark of a Third Party.

(d) GW Pharma has not received a written claim from a Third Party that the practice of the Licensed Intellectual Property or use of any of the Licensed Trademarks infringes or will infringe any Third Party rights.

(e) GW Pharma is not itself or through its Affiliates distributing, promoting, offering for sale or selling any potential or actual Branded Competing Products or any potential or actual Generic Competing Products in the Territory for the First Indication or the Second Indication. During the License Term, GW Pharma shall not, using its employees on its own behalf or through others or through its Affiliates, launch a potential or actual Branded Competing Product or a potential or actual Generic Competing Product in the Territory or otherwise have an interest in a potential or actual Branded Competing Product or a potential or actual Generic Competing Product in the Territory for the First Indication, the Second Indication, or any Additional Indication provided, however, that during the License Term, GW Pharma or its Affiliates may distribute, promote, offer for sale and sell such a potential or actual Branded Competing Product or potential or actual Generic Competing Products that it acquires as part of the acquisition of an entity, business or product line upon written notice Otsuka to such effect, but may not use its direct sales force to distribute, promote, offer for sale or sell such potential or actual Branded Competing Products or potential or actual Generic Competing Products; and provided, further, Otsuka may elect to take any or all of the actions set forth in Section 10.8(b)(i), Section 10.8(b)(ii) and Section 10.8(b)(iii), subject to subsections (w), (x), (y), and (z) of Section 10.8(b)(ii), in response to

such notice, distribution, promotion, offer for sale, or sale without waiting for the passage of sufficient time to determine whether following introduction to the market of any potential Branded Competitive Product or potential Generic Competitive Product there is an otherwise requisite reduction in Net Sales of Licensed Product. For clarity, in this Section “potential” refers to the fact that the Net Sales test within the definition of Branded Competing Product or Generic Competing Product has not then been satisfied.

(f) There are no outstanding liens, encumbrances, license grants or agreements, either written, oral or implied, regarding the Licensed Intellectual Property or the Licensed Trademarks which are inconsistent or in conflict with any provision of this Agreement

9.4 Disclaimer of Warranties . EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR WARRANTY TO THE OTHER PARTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.

9.5 Limitation of Liability . IN NO EVENT SHALL EITHER PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. This Section 9.5 shall not be construed to limit either Party’s obligations under Section 12.1.

ARTICLE 10

TERM; TERMINATION.

10.1 Term. This Agreement shall become binding only at the Closing; provided, however, Section 10.2, Section 13.3 and Section 13.13 hereof shall be binding as of the date of this Agreement above here written. Subject to the provisions of Section 13.13 neither Party shall be entitled to terminate this Agreement pending the occurrence of the Closing Date. Thereafter it shall continue in full force and effect until the later of: (i) cessation of the existence of any Valid Claim in the Territory, which would be infringed by the making, using, or selling of a Licensed Product in the Territory but for the Licenses granted pursuant to the Agreement, and (ii) *** years from commercial launch of the last Licensed Product for any indication (the “ License Term ”).

10.2 Otsuka and GW Pharma shall, with the assistance and cooperation of each other, as is necessary or desirable:

(a) make, as soon as reasonably practicable after the execution and delivery of this Agreement, such appropriate filings, notification, or reports as may be required by the HSR Act; and

(b) supply promptly any additional information and documentary material that may be requested by any United States anti-trust authority, including but not limited to the Federal Trade Commission or the Justice Department, pursuant to the HSR Act in relation to such HSR Act filing.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

10.3 Mutual Rights of Termination. Each Party shall have the right to terminate this Agreement:

(a) upon ninety (90) days’ prior written notice to the other Party upon the material breach of any provision of this Agreement by the other Party (provided that such breach is not due to the first Party’s breach) if the other Party has not cured or is not working diligently toward a cure of such breach (unless such breach is impossible to cure) within the ninety (90) day period following written notice of termination by the first Party and provided always that if the occurrence of such a material breach or breaches is disputed this Agreement shall not terminate pending a final resolution of such dispute under Section 11.2. For clarity, termination under Section 10.3(b), 10.4 and 10.5 and shall not constitute a termination for material breach under this Section 10.3 giving rise to a possibility of a delay to termination pending dispute resolution; or

(b) immediately upon written notice to the other Party upon the occurrence of any Insolvency Proceeding in respect of the other Party.

10.4 GW Pharma Rights of Termination . GW Pharma shall have the right to terminate this Agreement upon ninety (90) days’ prior written notice to Otsuka upon the occurrence of any of the following events, which is not cured during such ninety (90) day period:

(a) if Otsuka fails to launch the sale of the Licensed Product for the First Indication within the last to occur of (i) *** months of receipt of FDA Regulatory Approval and (ii) *** months of receipt of controlled drugs schedule assignment by the DEA;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

provided, however, that at such time GW Pharma is able to provide sufficient quantities of Licensed Product to Otsuka each calendar quarter to meet the Commercialization Plan, or

(b) if at any time after the first Full Regulatory Approval for any Licensed Product in contravention of an applicable Commercialization Plan Otsuka discontinues commercializing all Licensed Products or suspends the same for a period longer than *** months other than due to (i) the action or inaction of GW Pharma, or (ii) a significant medical, scientific, regulatory or intellectual property reason and subject to the right of Otsuka to terminate this Agreement for the same reason; or

(c) if prior to the grant of the first FDA Regulatory Approval for Licensed Product for any indication in the Territory either (i) in contravention of an applicable Development Plan Otsuka ceases, or suspends, or causes the cessation or *** months or more of the development of all Licensed Products other than due to (w) the action or inaction of GW Pharma, or (x) a significant medical, scientific, regulatory, or intellectual property reason and subject to the right of Otsuka to terminate this Agreement for the same reason.

10.5 Otsuka Rights of Termination . Otsuka shall have the right to terminate this Agreement either with respect to one or more Licensed Products, or in whole, upon providing the notice to GW Pharma indicated below upon the occurrence of any of the following events, which is not cured during the applicable notice period, if curable:

(a) upon ninety (90) days’ prior written notice at any time GW Pharma withdraws a Licensed Product from any market due to serious adverse events;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(b) upon ninety (90) days’ prior written notice at any time there arises, in the sole judgment of Otsuka, significant medical, scientific, regulatory or intellectual property issues pertaining to a Licensed Product;

(c) upon ninety (90) days’ prior written notice if Otsuka fails to agree with GW Pharma on the supply price for a Licensed Product following the emergence of a Branded Competitive Product or a Generic Branded Product in the Territory; or

(d) without cause, upon ninety (90) days’ prior written notice if Otsuka is not selling a Licensed Product at such time, or upon twelve (12) months’ prior written notice at any time Otsuka is selling a Licensed Product.

10.6 Rights in Bankruptcy . The Parties further agree that, in the event of the occurrence of an Insolvency Proceeding pertaining to GW Pharma:

(a) Otsuka shall have the option to acquire ownership of the entire right, title, and interest of GW Pharma in the GW Pharma Patent Rights in the Territory and the GW Pharma Know-How specific to the Territory and to acquire a fully paid up exclusive sub-licensable licence under other GW Pharma Know How such licence to be for use in the Territory (the “ Intangible Rights ”). GW Pharma shall provide prompt notice to Otsuka of the appointment of an Insolvency Officer or the commencement of an Insolvency Proceeding by or against GW Pharma under the insolvency laws of any jurisdiction. The option shall be exercisable by notice (the “ Option Notice ”) at any time during the sixty (60) day period following such event from Otsuka to GW Pharma of Otsuka’s intent to exercise the option. Otsuka shall nominate three prospective appraisers of recognized repute, and the Insolvency Officer shall select one of them for the purpose of appraising the Intangible Rights. The appraiser shall value the Intangible Rights at fair market value at the time of appraisal using the valuation technique believed by such appraiser to be most appropriate under the

circumstances. The appraisal report shall be prepared and distributed to Otsuka and the Insolvency Officer within thirty (30) days of engagement of the appraiser. Otsuka shall thereafter have thirty (30) days within which to provide notice (the “ Option Exercise Notice ”) to the Insolvency Officer of its exercise of the option to acquire the Intangible Rights. Otsuka and GW Pharma shall cooperate and act in good faith in respect of the exercise of the option and shall use every reasonable effort to cause the sale of the Intangible Rights shall to close within thirty (30) days following the Option Exercise Notice. If Otsuka does not provide an Option Exercise Notice, the fees and expenses of the Appraiser shall be borne by Otsuka. If Otsuka exercises the option, the fees and expenses of the appraiser shall be shared equally by Otsuka and GW Pharma.

(b) Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.

10.7 Effect of Expiration or Termination .

(a) Upon expiration of the License Term, all of the following will apply:

(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Section 2.1 of this Agreement shall be deemed to be paid-up and irrevocable;

(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply

Agreement for its term and Otsuka shall be entitled to exercise full manufacturing rights pursuant to Section 2.2;

(iii) Otsuka shall be entitled to require the transfer of manufacturing technology, protocols, standard operating procedures and the like as specified in the Manufacturing and Supply Agreement;

(iv) All licenses and associated rights granted to GW Pharma by Otsuka pursuant to Section 2.3 of this Agreement shall continue for the term of the Manufacturing and Supply Agreement so long as the Manufacturing and Supply Agreement is not terminated by Otsuka or manufacture of the Licensed Products is assumed by Otsuka but without terminating the Manufacturing and Supply Agreement;

(v) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.

(vi) The license and associated rights granted by Otsuka to GW Pharma pursuant to Section 2.3 of this Agreement shall continue in full force and effect as a royalty-free license, and otherwise on the same terms as set forth in Section2.3

(b) If this Agreement is terminated by Otsuka pursuant to Section 10.3(a) or 10.3(b), all of the following will apply:

(i) All licenses and associated rights granted to Otsuka by GW Pharma pursuant to Sections2.1 and 2.4 of this Agreement shall continue in full force and effect as perpetual licenses, but otherwise on the same terms as set forth in Sections 2.1 and 2.4 and the remainder of this Agreement, and all amounts that absent such termination

would be due to GW Pharma hereunder as Product Royalties shall continue to be due, but only in the case of termination under Section 10.3(a) shall be due in amounts reduced by *** percent (***%) of amounts that would otherwise be due. Otsuka will be entitled to a complete duplicate of (or complete access to, as appropriate) the Licensed Intellectual Property and all embodiments of the Licensed Intellectual Property, and same, if not already in its possession, will be promptly delivered to it.

(ii) GW Pharma shall, at Otsuka’s election, continue to supply Licensed Products to Otsuka on the terms of the Manufacturing and Supply Agreement for the longer of its term or up to three (3) years at the discretion of Otsuka.

(iii) In its sole discretion Otsuka shall have the right to terminate the Manufacture and Supply Agreement according to its terms including as to notice period and have the right to ask GW Pharma to offer terms for the future supply of Licensed Products or just BDS, such offer to be made in GW Pharma’s discretion.

(iv) The license granted by Otsuka to GW Pharma under Section 2.3. of this Agreement shall continue in full force and effect on the terms set forth in Section 2.3and as set out below: (i) where the Agreement has been terminated under Section 10.3(b) such license shall continue to be a royalty-free license; and (ii) where the Agreement has been terminated under Section 10.3(a) such continuing license shall require the payment by GW Pharma of a royalty of *** percent (***%) on net sales of products made by GW Pharma, its Affiliates and its sub-licensees covered by a Valid Claim of a Joint Patent or Otsuka Patent Rights in the country of sale, such net sales to be calculated in a manner

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

comparable to that set forth in Section 1.58. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.

(v) GW Pharma shall, to the extent legally practicable, assign to Otsuka its right, title and interest in and to each IND and all other regulatory filings with respect to any Licensed Product in the Territory save for such DEA Regulatory Approvals and other regulatory approvals necessary for GW Pharma to supply Otsuka under the Manufacturing and Supply Agreement if this is still continuing, and GW Pharma shall deliver promptly to Otsuka all tangible manifestations of the same.

(c) If this Agreement is terminated by GW Pharma pursuant to Section 10.3(a), 10.3(b) or 10.4 or by Otsuka pursuant to Section 10.5 all of the following will apply:

(i) The licenses and associated rights granted by GW Pharma to Otsuka under Sections 2.1 and 2.4 of this Agreement shall terminate and be of no further force or effect.

(ii) The license granted by Otsuka to GW Pharma under Section 2.3 of this Agreement shall continue in full force and effect as a worldwide royalty-free license, and otherwise on the same terms as set forth in Section 2.3. GW Pharma shall be entitled to a complete duplicate of (or complete access to, as appropriate) the Otsuka Clinical Data and all relevant Otsuka Know-How and all embodiments thereof, and the same, if not already in its possession, will be promptly delivered to it.

(iii) Notwithstanding any other provision of this Section 10.7(c), Otsuka and its sublicensees shall have the right and license in the Field to sell, offer for sale, have sold, import and export all existing inventories of each Licensed Product then under their control for up to six (6) months following termination, subject to the continuing application of this Agreement and the prevailing right of GW Pharma, upon ninety (90) days advance written notice, to purchase such entire remaining inventory of Licensed Products, at a cost equal to the aggregate Supply Compensation, transportation and insurance costs when originally shipped to Otsuka and then returned to GW Pharma hereunder, and other handling expenses paid by Otsuka for such inventory.

(iv) Commensurate with then current legislative and regulatory requirements Otsuka shall as soon as practicably possible after termination transfer to GW Pharma or its nominee all right, title and interest in all relevant INDs, NDAs, or FDA Regulatory Approvals or DEA Regulatory Approvals held by it or any sub-licensee for the Licensed Products (“Product Registration”). GW Pharma acknowledges that Otsuka will, within thirty (30) days of the Closing Date, execute letters addressed to FDA and DEA to effect these transfers, the form of which letters are set out in Exhibit H. The signed but undated originals of such letters will be provided by Otsuka to Morrison & Foerster within thirty (30) days from the Closing Date to be held by Morrison & Foerster in escrow and Morrison & Foerster will confirm to Otsuka in writing that they will only release the same to GW Pharma upon receipt of written confirmation by GW Pharma signed by both its then current Chairman and CEO that termination has occurred and under the circumstances of Section 10.7(c) the letters are to be released, subject to the conclusion of any dispute resolution procedure pursuant to Section 10.3(a) and Section11.2. Upon grant of an IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval to Otsuka in respect of a Licensed Product Otsuka hereby irrevocably authorizes Morrison & Foerster as escrow agent

to insert the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval reference number allocated by the FDA or the DEA, as applicable, and the name and brief description of the Licensed Product the object of the IND, NDA, FDA Regulatory Approval or DEA Regulatory Approval into the letters signed by Otsuka and held in escrow. Otsuka hereby irrevocably authorizes GW Pharma to complete and date these letters with the date that it receives them from Morrison & Foerster and to submit them to the FDA and DEA respectively. Otsuka shall also deliver promptly to GW Pharma all tangible manifestations of any such INDs, NDAs or Full Regulatory Approvals.

(d) If a portion of the license granted by GW Pharma to Otsuka under Section 2.1 is terminated by Otsuka, in relation to a particular Licensed Product then the provisions set out in Section 10.7(c)(i), 10.7(c)(ii), 10.7(c)(iii) and 10.7(c)(iv) shall apply but only in relation to that Licensed Product.

(e) Within thirty (30) days following the expiration of the License Term or termination of this Agreement, each Party shall return to the other Party or destroy, upon the written request of the other Party, any and all Confidential Information of the other Party in its possession, except, to the extent and for so long as such Party retains a license hereunder as provided by this Article 10 provided, however, that each Party may retain one copy of the other Party’s Confidential Information for the sole purpose of monitoring compliance with its obligations hereunder.

(f) Expiration of the License Term or termination of this Agreement shall not (i) affect any other rights of either Party which may have accrued up to the date of such termination or (ii) preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. Subject always to other provisions of this Agreement that provide for survival of certain

provisions following expiration or termination, the provisions of Article 1 (all), Article 4 (due, but unpaid obligations), Article 5 (in relation to activities occurring prior to expiration or termination), Article 6 (Confidentiality),Sections 9.4, 9.5, 10.6 to 10.8 inclusive, Article 11, Article 12 and Article 13 shall survive expiration or termination of this Agreement.

10.8 Termination for Change of Control.

(a) Each Party shall provide written notice to the other Party of an impending Change of Control of itself as soon as the impending Change of Control can be legally disclosed. Within fifteen (15) days of the receipt of a written notice pursuant to this Section 10.8, a senior executive of each Party shall meet to discuss the impact of any proposed Change of Control upon the Agreement and to discuss the possible nature of the relationship between the Parties following its Change of Control.

(b) In the event of a Change of Control of GW Pharma or its parent by a Qualifying Pharmaceutical Company, Otsuka at its election shall be entitled on written notice of GW Pharma to take any or all of the following actions (and, for clarity, there shall be no other changes to the terms of this Agreement):

(i) Promptly to disband the JCC, JDC and all sub-committees; and

(ii) To conduct all outstanding development activities under any Development Plan itself and GW Pharma shall use reasonable efforts to transfer the same to Otsuka promptly after receipt of Otsuka’s written notice; and

(iii) To cause, by notice to GW Pharma, 2.2 to be deemed to be deleted from this Agreement; and

(iv) To cease all reporting of progress with development and commercialization of Products save that:

(w) nothing shall affect the licenses granted hereunder to GW Pharma and the related transfers of Otsuka Clinical Data, Otsuka Know-How and information under Article 7; and

(x) Otsuka shall provide not less than once each year a report detailing in outline its progress with the development of Licensed Products in sufficient detail for GW Pharma to be able to anticipate milestone events, the grant of FDA Regulatory Approvals and DEA Regulatory Approvals and Launch of Licensed Product for each Indication; and

(y) Otsuka shall continue to provide royalty reporting under Section 5.3; and

(z) for clarity, all other forms of reporting and communication specified in this agreement shall continue.

(c) In the event of a Change of Control of GW Pharma or its parent by any company if subsequently it is identified that such company markets and sells or has marketed and sold on its behalf in the Territory either a Branded Competitive Product or a Generic Competitive Product (i.e., the appropriate period of time has elapsed post such Change of Control to determine that such a Branded Competitive Product or a Generic Competitive Product exists) Otsuka shall notify GW Pharma and the acquiring company in writing of this fact and unless:

(i) Within sixty (60) days of such written notice the acquiring company agrees to divest itself of such Branded Competitive Product or Generic Competitive Product as the case may be; and

(ii) Within one (1) year of such written notice it actually does so Otsuka shall be entitled to terminate this Agreement on ninety (90) days written notice to GW Pharma with consequences of termination the same as set out in Section 10.7(b) save that under Section 10.7(b)(i) there shall be no *** percent reduction in Product Royalties.

(d) In the event of a Change of Control of Otsuka, its Affiliates or its parent by any company if subsequently it is identified that such company markets and sells or has marketed and sold in the Territory either a Branded Competitive Product or a Generic Competitive Product (i.e., the appropriate period of time has elapsed post such Change of Control to determine that such a Branded Competitive Product or a Generic Competitive Product exists) GW Pharma shall notify Otsuka and the acquiring company in writing of this fact and unless:

(i) within sixty (60) days of such written notice the acquiring company agrees to divest itself of such Branded Competitive Product or Generic Competitive Product as the case may be; and

(ii) within one (1) year of such written notice it actually does so GW Pharma shall be entitled to terminate this Agreement on ninety (90) days written notice to Otsuka with consequences of termination the same as set out in Section 10.7(b) save

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

that under 10.7(b)(i) there shall be no royalty payments due to Otsuka from GW Pharma and this License shall be irrevocable and fully paid-up.

ARTICLE 11

DISPUTE RESOLUTION.

11.1 Dispute Resolution . During the License Term, any material disputes or disagreements between Otsuka and GW Pharma arising under this Agreement and not within the authority of the JCC to resolve shall be referred to the Chief Executive Officer of Otsuka and the Managing Director of GW Pharma or their designees for good faith resolution for a period of thirty (30) days. If such officers of the Parties cannot resolve such issue, then such issue shall be resolved in accordance with Section 11.2.

11.2 Arbitration . Any controversy arising under or related to this Agreement that is neither within the authority of the JCC to resolve nor has been resolved pursuant to Section 11.1, as applicable (excluding, in any event, any dispute relating to patent scope, validity or infringement arising under this Agreement or as to specific performance under Section 13.12(b), shall be settled by arbitration in accordance with the then existing International Arbitration Rules of the International Centre for Dispute Resolution. Upon request by either Party, arbitration will be by a panel of three (3) arbitrators within thirty (30) days of such arbitration request. Each Party shall select one arbitrator and the third shall be mutually agreed upon in writing by both Parties. In any such arbitration, Otsuka and GW Pharma shall select a panel with relevant experience in the pharmaceutical industry. The arbitrators shall, within fifteen (15) days after the conclusion of the arbitration hearing, issue a written award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The arbitrators shall be

authorized to award compensatory damages, but shall not be authorized (i) to award non-economic damages, such as for emotional distress, pain and suffering or loss of consortium, (ii) to award punitive damages, or (iii) to reform, modify or materially change this Agreement, the Manufacturing and Supply Agreement or any other agreements contemplated hereunder or thereunder. The arbitrators also shall be authorized to grant any temporary, preliminary or permanent equitable remedy or relief they deem just and equitable and within the scope of this Agreement and/or the Manufacturing and Supply Agreement, as applicable, including, without limitation, an injunction or order for specific performance. Each Party shall bear its own attorney’s fees, costs and disbursements arising out of the arbitration and shall pay an equal share of the fees and costs of the arbitrators; provided, however, the arbitrators shall be authorized to determine whether a Party is the prevailing Party and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs of the arbitrators. Each Party shall fully perform and satisfy the arbitration award within fifteen (15) days of the service of the award. By agreeing to this binding arbitration provision, the Parties understand that they are waiving certain rights and protections which may otherwise be available if a claim between the Parties were determined by litigation in court, including, without limitation, the right to seek or obtain certain types of damages precluded by this provision, the right to a jury trial, certain rights of appeal and a right to invoke formal rules of procedure and evidence. Judgment upon the award rendered by the panel shall be final and non-appealable and may be entered in any court having jurisdiction thereof. The Parties shall be entitled to all discovery in like manner as if the arbitration were a civil suit in the New York Supreme Court. Any arbitration under this Article 11 shall be held in New York, New York, if GW Pharma instigates proceedings

and in London, England if Otsuka initiates proceedings unless the Parties hereto mutually agree in writing to another place.

11.3 Injunctive Relief . Notwithstanding the foregoing, either Party shall have the right to pursue an action in a court of competent jurisdiction to obtain injunctive or other equitable remedy, in order to preserve the status quo during the resolution of any dispute under this provision.

ARTICLE 12

INDEMNIFICATION AND INSURANCE.

12.1 Indemnity .

(a) GW Pharma shall indemnify, defend and hold Otsuka, its Affiliates and their respective directors, officers, employees, consultants and sublicensees (each, an “ Otsuka Indemnitee ”) harmless from and against any and all costs, losses, claims, liabilities, fines, penalties, damages and expenses, court costs and reasonable fees and disbursements of counsel, consultants and expert witnesses (collectively, “ Damages ”) incurred or suffered by an Otsuka Indemnitee as a result of Third Party claims, actions or proceedings resulting from either (a) personal injury or death caused by administration of a Licensed Product to such person; or (b) property or other damage caused by a Licensed Product ((a) and (b) collectively, “ Third Party Claims ”) in either circumstance occurring (i) anywhere in the world prior to the Closing Date; or (ii) outside the Territory after the Closing Date; or (iii) anywhere in the world resulting from development activities conducted or managed by GW Pharma pursuant to the Development Plan for the First Indication; or (iv) anywhere in the world due to the negligent acts or omissions or willful misconduct of any GW Pharma Indemnitee; or (v) inside the Territory following the termination of this

Agreement in circumstances where Section 10.7(c) applies and where rights to the Licensed Products revert to GW Pharma inside the Territory (but excluding circumstances where Otsuka exercises its rights to sell off inventory under Section 10.7(c)(iii), or 10.7(c)(iv) or (vi) inside the Territory during the term of this Agreement and resulting from Licensed Product manufactured by GW Pharma, its Affiliates or contractors and supplied to Otsuka pursuant to the Manufacture and Supply Agreement for use in the Territory where it is proved that such Licensed Product did not meet the Specifications at the time of delivery, in each of the foregoing cases except to the extent that such Damages result from the negligent acts or omissions or willful misconduct of an Otsuka Indemnitee.

(b) Otsuka shall indemnify, defend and hold GW Pharma, its Affiliates and their respective directors, officers, employees, consultants and sublicensees (each, a “ GW Pharma Indemnitee ”) harmless from and against any and all Damages incurred or suffered by a GW Pharma Indemnitee as a result of Third Party Claims where either circumstance of such Third Party Claims occurs (i) as a result of Licensed Product used or existing in the Territory during the term of this Agreement, or (ii) anywhere in the world due to the negligent acts or omissions or willful misconduct of any Otsuka Indemnitee, or (iii) inside the Territory following the expiration or termination of this Agreement save in circumstances where rights to Licensed Products inside the Territory revert to GW Pharma save, in each case for the circumstances for which GW Pharma is liable specified in Section 12.1(a) above, and in each case except to the extent that such Damages result from the negligent acts or omissions or willful misconduct of a GW Pharma Indemnitee.

12.2 Notice and Assistance . An indemnified person under Sections 12.1(a) or 12.1(b) (“ Indemnified Party ”) shall give the indemnifying party under Sections 12.1(a) or 12.1(b) (“ Indemnifying Party ”) prompt written notice of any Loss or discovery of any

relevant Third Party Claim upon which such Indemnified Party intends to base a request for indemnification under Sections 12.1(a) or 12.1(b) (an “ Indemnification Claim Notice ”). Where required the Indemnifying Party shall promptly send a copy of the Indemnification Claim Notice to its relevant insurers and shall permit them to exercise their rights of subrogation and hereafter in this Article 12 “Indemnifying Party” shall be deemed to include any such insurers. In no event shall the Indemnifying Party be liable for any Damages that results from any delay in providing the Indemnification Claim Notice. Each Indemnification Claim Notice shall contain a description of the claim and the nature and amount of the Damages claimed (to the extent that the nature and amount of such Damages is known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all correspondence, communications and official documents (including court documents) received in respect of any such Damages. For the avoidance of doubt, all indemnification claims in respect of a Party, its Affiliates or their respective directors, officers, employees and agents (each, an “ Indemnitee ”) shall be made solely by a Party to this Agreement or its insurers.

12.3 The obligations of an Indemnifying Party under this Article 12 shall be governed by and contingent upon the following:

(a) At its option, the Indemnifying Party may assume control of the defense of any Third Party Claim (which, for the avoidance of doubt, shall include the conduct of all dealings with such Third Party) by giving written notice to the Indemnified Party within fourteen (14) days after the Indemnifying Party’s receipt of an Indemnification Claim Notice. The assumption of control of the defense of a Third Party Claim by the Indemnifying Party shall not be construed as an acknowledgement that the Indemnifying Party is liable to indemnify any Indemnitee in respect of the Third Party Claim, nor shall it

constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification.

(b) Upon the assumption of the control of the defense of a Third Party Claim by the Indemnifying Party:

(i) subject to the provisions of Section 12.3(c) , it shall have the right to and shall assume sole control and responsibility for dealing with the Third Party and the Third Party Claim, including the right to settle the claim on any terms the Indemnifying Party chooses, but at all times in accordance with the provisions of Section 12.3(d);

(ii) if it chooses, the Indemnifying Party may appoint as counsel in the defense of the Third Party Claim any law firm or counsel selected by the Indemnifying Party; and

(iii) except as expressly provided in Section 12.3(c), the Indemnifying Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party or any Indemnitee in connection with the analysis, defense or settlement of the Third Party Claim. In the event that it is ultimately determined that the Indemnifying Party is not obligated to indemnify, defend or hold harmless an Indemnitee from and against the Third Party Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all costs and expenses (including lawyers’ fees and costs of suit) and any Damages incurred by the Indemnifying Party in its defense of the Third Party Claim with respect to such Indemnified Party or Indemnitee.

(c) Without limiting the remainder of this Section 12.3, any Indemnitee shall be entitled to participate in, but not control, the defense of a Third Party

Claim by having its views regularly solicited by the Indemnifying Party and, where proceedings are commenced, to retain counsel of its choice for such purpose; provided, however, that such retention shall be at the Indemnitee’s own expense unless, (a) the Indemnifying Party has failed to assume the defense and retain counsel in accordance with Section 12.3(a) (in which case the Indemnified Party shall control the defense), or (b) the interests of the Indemnitee and the Indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both Parties under any applicable Laws, ethical rules or equitable principles.

(d) With respect to any Damages relating solely to the payment of money to the Third Party to settle the Third Party Claim and that will not result in the Indemnified Party or the Indemnitee becoming subject to injunctive relief, and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnitee under Section 12.3(a), the Indemnifying Party shall have the sole right to enter into any such settlement including any consent judgment, on such terms as the Indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Damages or where the Indemnified Party will be subject to injunctive relief or where the settlement entails an admission of fault on the part of the Indemnified Party, where the Indemnifying Party has assumed the defense of a Third Party Claim in accordance with Section 12.3(a), the Indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Damages, provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld or delayed).

(e) If the Indemnifying Party chooses not to take control of the defense or prosecute any Third Party Claim, the Indemnified Party shall retain control of the

defense thereof but no Indemnified Party or Indemnitee shall admit any liability with respect to, or settle, compromise or discharge, any such Third Party Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld or delayed. The Indemnifying Party shall not be liable for any settlement or other disposition of Damages by an Indemnified Party or an Indemnitee under such a Third Party Claim that is reached without the written consent of the Indemnifying Party.

(f) If the Indemnifying Party chooses to control the defense of any Third Party Claim, the Indemnified Party shall, and shall cause each other Indemnitee to, reasonably cooperate in the defense thereof and shall furnish such records, information and testimony, provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party Claim, and making the Indemnified Party, the Indemnitees and its and their employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided, and the Indemnifying Party shall reimburse the Indemnified Party for all of its related reasonable out-of-pocket expenses.

(g) Except as expressly provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party where it participates in the defense under Section 12.3(c) or Section 12.3(e) shall be reimbursed on a Quarterly basis by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification

and subject to refund in the event the Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party.

12.4 Insurance . Each of the Parties and their respective Affiliates and sublicensees acting under this Agreement, at their own expense, shall procure and maintain in full force and effect during the term of this Agreement and thereafter for two (2) years, comprehensive general liability insurance including, but not limited to, contractual liability coverage and product liability coverage, in each case comparable to that maintained by other similarly situated pharmaceutical companies engaged in clinical research, development, sales and marketing of products for therapeutic use in humans, taking into account the nature of the Licensed Products and, at a Party’s or its designee’s request, shall provide the other Party or its designee, with proof of such coverage.

ARTICLE 13

MISCELLANEOUS.

13.1 Assignment . Except as expressly provided hereunder, neither this Agreement nor any rights or obligations hereunder may be assigned or otherwise transferred by either Party without the prior written consent of the other Party (which consent shall not be unreasonably withheld); provided, however, that either Party may assign this Agreement and its rights and obligations hereunder without the other Party’s consent (a) in connection with the transfer or sale of all or substantially all of the business of such Party to which this Agreement relates to a Third Party, whether by merger, sale of stock, sale of assets or otherwise, or (b) to any Affiliate. For the avoidance of doubt, Otsuka may assign its rights or obligations under this Agreement, in whole or in part, to one or more Affiliates without the consent of GW Pharma. In addition, Otsuka shall be entitled to perform any of its obligations

under this Agreement through the use of contractors. Notwithstanding the foregoing, any assignment to an Affiliate or any use of contractors by Otsuka shall not relieve the assigning Party (or Otsuka with regard to contractors) of its responsibilities for performance of its obligations under this Agreement. The rights and obligations of the Parties under this Agreement shall be binding upon and inure to the benefit of the successors and permitted assigns of the Parties. Any assignment not in accordance with this Agreement shall be void.

13.2 Force Majeure . Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or performing any term of the Agreement when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, including, without limitation, fire, floods, earthquakes, natural disasters, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, terrorism, civil commotions, strikes, lockouts or other labor disturbances, acts of God or acts, omissions or delays in acting by any governmental authority or the other Party.

13.3 Governing Law . This Agreement shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to its choice of law provisions.

13.4 Waiver . Except as specifically provided for herein, the waiver from time to time by either Party of any right or failure to exercise any remedy shall not operate or be construed as a continuing waiver of the same right or remedy or of any other of such Party’s rights or remedies provided under this Agreement.

13.5 Severability . In case any provision of this Agreement shall be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be affected or impaired thereby.

13.6 Independent Contractors . It is expressly agreed that Otsuka and GW Pharma shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency of any kind. Neither Party shall have the authority to make any statements, representations or commitments of any kind or to take any action, which shall be binding on the other Party, without the prior written consent of the other Party.

13.7 Notices . All notices and other communications provided for hereunder shall be in writing and shall be mailed by first-class, registered or certified mail, postage paid or delivered personally, by overnight delivery service or by facsimile, with confirmation of receipt, addressed as follows:

If to Otsuka:	Licensing Department
	***
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with a copy to:	Legal Affairs Department
	***,
	***,
	***
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

	***:

	***
	***,
	***
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If to GW Pharma:	Porton Down Science Park
	Salisbury
	Wiltshire
	SP4 0JQ
	Attention: Company Secretary
	Facsimile: +44 (0) 1980 557 111

13.8 No Implied License. Except as expressly provided herein, no Party hereto shall be deemed by this Agreement to have been granted any license or other rights to patent rights existing as of the date hereof or know-how relating to compounds, formulations or processes which are owned, licensed or controlled by another Party.

13.9 Entire Agreement; Amendment . This Agreement and its Exhibits, set forth the only agreements and understandings between the Parties hereto with respect to the subject matter hereof and thereof and supersede and terminate all prior agreements and understandings between the Parties with respect to the subject matter hereof and thereof. There are no other agreements or understandings with respect to the subject matter hereof,

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

either oral or written, between the Parties. Except as expressly set forth in this Agreement, no subsequent amendment, modification or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of the Parties.

13.10 Headings . The captions contained in this Agreement are not a part of this Agreement, but are merely guides or labels to assist in locating and reading the several Articles hereof.

13.11 Counterparts . This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

13.12 Supplemental Rights .

(a) Otsuka shall be entitled to undertake and perform any or all obligations of GW Pharma under this Agreement in the event GW Pharma fails to perform any of its obligations under this Agreement other than due to a significant medical, scientific, regulatory or intellectual property reason and having been given notice to cure by Otsuka under Section 10.3(a) and having failed to use or work diligently toward a cure within the ninety (90) day period following the termination.

(b) If at any time an Insolvency Officer has been appointed in respect of GW there has occurred an Insolvency Proceeding, Otsuka shall be entitled to undertake and perform at its own cost, any and all/or all of the obligations of GW Pharma under this Agreement. Otsuka may thereafter deduct the cost to it of performing GW Pharma’s obligations from any payments that are due to GW Pharma under this Agreement thereafter.

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(c) GW Pharma shall make available to Otsuka as soon as possible on request by Otsuka, any documentation and information that Otsuka deems necessary or desirable, and any access to premises, staff or intellectual property agents of GW Pharma that Otsuka deems necessary or desirable, to enable it to perform GW Pharma’s obligations pursuant to this Section 13.12.

(d) GW Pharma hereby acknowledges that if it is unable to perform its obligations to Otsuka under this Agreement, then damages to Otsuka will be an inadequate remedy and Otsuka shall be entitled to seek an order of specific performance from the English Courts which will have jurisdiction in this case;

(e) GW Pharma and Otsuka hereby agree that this Agreement shall be promptly registered or filed, as the case may be, in such jurisdictions with such governmental offices as may be determined from time to time by Otsuka, in its sole discretion, for the purpose of putting Third Parties on notice of the existence of, and Otsuka’s rights under, this Agreement, and perfecting Otsuka’s interest herein. Where such purposes may be accomplished through the registration or filing of a memorandum or other abbreviated version of this Agreement, such a memorandum or abbreviated version shall be prepared by Otsuka for filing. GW Pharma shall fully cooperate with Otsuka in such preparations and filings including, but not limited to, executing documents and taking such other actions as may be requested by Otsuka in connection with effectuating the foregoing purposes. Otsuka shall bear the costs of all such registrations and filings and shall reimburse GW

13.13 Hart Scott Rodino Filing Fees . Otsuka shall pay all filing fees required in connection with mandatory filings under the Hart Scott Rodino Antitrust Improvements Act, as amended (“HSR Act”). If the Closing Date has not occurred within nine (9) months after

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the date first written above either Party may terminate this Agreement, upon ten (10) days’ prior written notice to the other Party, in which case this Agreement shall forthwith become void and there shall be no liability or obligations on the part of GW Pharma or Otsuka or their respective Affiliates, officers, directors or shareholders.

ARTICLE 14 GUARANTEE BY GW PHARMA PLC

14.1 GW Pharmaceuticals plc is party to this Agreement solely for the purpose of the guarantee set out in this Section 14 and has no other rights or obligations hereunder.

14.2 GW Pharmaceuticals plc hereby unconditionally and irrevocably guarantees to Otsuka the performance of all the financial obligations of GW Pharma under this Agreement, including the due and prompt payment by GW Pharma of any amounts payable under this Agreement and any damages or other financial compensation for breach of this Agreement by GW Pharma or otherwise connected with GW Pharma’s activities under this Agreement. In case of the failure of GW Pharma to promptly pay any amounts or to make whole Otsuka for any of its obligations under this Agreement, GW Pharmaceuticals plc hereby agrees to cause the payment of such amounts to be made promptly when and as such amounts become due and payable and as if such amounts were paid by GW Pharma.

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In Witness Whereof , the Parties have executed this Development and License Agreement.

GW PHARMA LTD		OTSUKA PHARMACEUTICAL CO., LTD.

By::	/s/ Geoffrey Guy	By: :	/s/ Tatsuo Higuchi

Name:	Geoffrey Guy	Name:	Tatsuo Higuchi

Title:	Executive Chairman	Title:	President and Representative Director

By:	/s/ Justin Gover	By:	/s/ Hiromi Yoshikawa

Name:	Justin Gover	Name:	Hiromi Yoshikawa

Title:	Managing Director	Title:	Board Director, Responsible for United States and
			Pharmaceutical Business Division

GW PHARMACEUTICALS PLC

By::	/s/ Geoffrey Guy

Name:	Geoffrey Guy

Title:	Executive Chairman

By:	/s/ Justin Gover

Name:	Justin Gover

Title:	Managing Director

Exhibit A

GW PHARMA PATENT RIGHTS

Ref No.	Country	App No.	App Date	Pub No.	Status
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit B

EXISTING LICENSED PRODUCT

1. Pharmaceutical Form

Oromucosal spray.

Solution contained in an amber glass vial fitted with a metering pump delivering 100 microlitres per actuation (spray).

2. Vials

filled volumes of 5.5 ml and/or 10 ml.

3. Qualitative and Quantitative Composition

Each vial contains the following active ingredients in the concentrations listed:

delta-9-tetrahydrocannabinol 27mg/ml (from Tetranabinex - Cannabis sativa L. extract) and cannabidiol 25mg/ml (from Nabidiolex - Cannabis sativa L. extract)

Each 100 microlitre spray contains:

2.7 mg delta-9-tetrahydrocannabinol (THC Botanical Drug Substance) and 2.5 mg cannabidiol (CBD Botanical Drug Substance).

Excipients:

1. Ethanol anhydrous

2. Propylene glycol

3. Peppermint oil

Exhibit C

TRADEMARKS

Ref No.	Country	Number	Priority (App. Date)	Classes	Status
***	***	***	***	***	***
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EXHIBIT D

DEVELOPMENT PLAN

[Page left intentionally blank]

PRELIMINARY FIRST INDICATION DEVELOPMENT PLAN

1.1 INTRODUCTION

Sativex has an IND *** to enter directly into late stage development in the US for the following indication.

“ Sativex is indicated as add-on treatment in the relief of cancer related pain in patients with advanced cancer whose pain has not been adequately relieved with optimal doses of opioids”.

Cancer-related pain can be defined as pain caused by cancer, by cancer treatment such as surgery, radiation therapy or chemotherapy, or by the side effects of treatment.

Severe pain is experienced by at least two thirds of patients with advanced disease. While the majority of these patients may have their pain adequately treated with existing opioid based approaches, between 14 and 47% of them will achieve inadequate pain relief and will continue to suffer pain which is at least moderate in intensity (Zech DF, Grond S, Lynch J et al. Validation of WHO guidelines for cancer pain relief — a 10 year prospective study. Pain 1995; 63: 65-76.).

Chronic cancer pain may be insensitive to opioids (McQuay H. Lancet 1999; 353: 2229-32), even when an appropriate dose titration regimen has been used.

In a review of the management of cancer pain commissioned by the United States Agency for Research and Quality (AHRQ), the authors concluded that randomized controlled trials constitute only about 1% of the published literature on cancer pain, and are often of poor methodologic quality. This conclusion has been amplified recently in a review article by Nathaniel Katz, until recently Chairman of the US FDA’s Pain Advisory Panel. (Katz N. Neurology 2005; 65 (suppl 4) S32-S49e ). It is for these reasons, and the fact that mu opioid receptor agonists each act in the same way, that the opioid insensitive patient offers a significant challenge, and why there is such a clear medical need for a non-opioid analgesic which can bring additional pain relief to these patients.

1.2 DESCRIPTION OF THE PRODUCT

Sativex ® is a pump action oro-mucosal spray, which contains 2 whole plant extracts (Botanical Drug Substances, BDSs) of Cannabis sativa L. ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Sativex ® contains the following:

Components	Amount per unit (1ml)	Function
***:
***	***	***
***	***	***
***:
***	***	***
***	***	***
***	***	***

1.2.2 Structures and Numbering of THC and CBD Molecules

***

1.3 SUMMARY OF PHARMACOLOGY

The pharmacology of the principal cannabinoids within Sativex has been comprehensively reviewed by several external authors (Pertwee 2003, 2005). It is summarised here.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Table 1: Summary of the Pharmacology of THC and CBD

Effect	THC	CBD	Reference
***	***	***	***
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CNS effects
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Cardiovascular effects
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Anti-inflammatory effects
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***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.4 TARGET PRODUCT PROFILE

***	***
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1.5 MARKETING ASSUMPTIONS

To be completed

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.6 OVERALL DEVELOPMENT STRATEGY

1. ***

2. ***

3. ***

1.6.1 ELEMENTS OF DEVELOPMENT

1.6.1.1 Chemistry, Manufacturing and Controls

a) ***:

***

***:

*******		*******
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***

1.6.1.2 Pre-Clinical

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

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Additional Studies to be done:

***

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***

***

1.6.1.3 Clinical.

Overview:

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

Phase 1.

***

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Phase 2

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

*******		*******		*******
***		***		***

Phase 3.

***:

1. ***

2. ***

3. ***

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Preparations for Phase 3:

1. ***

2. ***

3. ***

4. ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

*******	*******	*******
1. ***,	* *	***
2. ***
3. ***

***

1.6.1.4 Other Elements of Product Development Plan

1. ***

***

***:

· ***

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.7 DEVELOPMENT CHALLENGES AND OPPORTUNITIES

***

Clinical

***

1. ***

· ***

2. ***

· ***

3. ***

· ***

4. ***

· ***

CMC

***

5. ***

6. ***

7. ***

PRE-CLINICAL

***

8. ***

9. ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.8 MAJOR DEVELOPMENT MILESTONES

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***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Annex — Estimate of Development Plan Costs for first Indication

***

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***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EXHIBIT E

RESEARCH COLLABORATION KEY PRINCIPLES

The Parties agree to negotiate in good faith and enter into a cannabinoid research collaboration, in the form of a definitive written research, development and license agreement (the “ Agreement ”), as soon as reasonably practicable but with the intention that this occurs within one hundred twenty (120) days of the date first above written (or such longer period as may be agreeable to the Parties) based on discussions between the Parties as reflected in the principles set out below:

GW and Otsuka plan to perform a research collaboration pursuant to an agreed research plan and agreed research budget. The research budget shall be funded by Otsuka. As the Parties agree is appropriate, the Agreement in general and each annual research plan in greater detail, shall set forth the research activities, the Party responsible for conducting such activity and the activities to be charged against the annual research budget (or, as agreed by each Party, undertaken at the expense of such Party outside the research budget).

The objective of the research collaboration shall be (i) to identify, research and advance one or more cannabinoid drug candidates to full clinical development and (ii) to conduct such other research activities as the Parties may agree, all in accordance with the research plan.

The Field of the research collaboration shall be directed at the treatment, diagnosis, prevention, or palliation of (i) diseases, conditions, syndromes, and maladies of the central and peripheral nervous systems of humans and animals and (ii) cancer in humans and animals.

The Parties shall form a Joint Research Committee (JRC) to oversee the collaboration.

The research plan shall be prepared in advance of each research year and agreed by the Parties on the JRC. It shall set forth in detail the research and development plan, timeline,

budget and each Party’s activities to be undertaken and milestones to be achieved. The initial research plan shall be an exhibit attached to the Agreement.

In accordance with the research plan and research budget, GW and Otsuka will evaluate of a range of cannabinoids as drug candidates for applications within the Field, with a view to selecting the most promising candidates for full clinical development, regulatory approval and global commercialization by Otsuka. If Otsuka chooses to further develop and commercialize any Products resulting from the research collaboration it will have an exclusive worldwide license to do so. Such further development and commercialization of Products selected by Otsuka shall be at Otsuka’s risk and cost. The Agreement shall detail as a minimum the principal terms of such license, including provisions related to the treatment of Products not selected by Otsuka but which may be competitive to Products which have been selected by Otsuka for further development and commercialization.

The initial term of the research collaboration will be three years, which may be extended by mutual agreement.

Initial and ongoing funding of GW’s anticipated costs under a research plan and research budget and payment procedures therefor shall be agreed by the Parties in the Agreement.

GW shall permit up to three Otsuka scientists to work at GW’s facility.

At an appropriate time prior to the first clinical development by Otsuka of a Product GW and Otsuka will enter into a Manufacturing and Supply Agreement for supplies of Product.

The financial and other customary terms for a license pertaining to Otsuka’s development and commercialization rights in a selected Product and the supply price therefor shall be commercially reasonable, negotiated and agreed between the Parties in good faith. Such

terms shall include commercially reasonable royalties, milestone payments and supply price provisions.

EXHIBIT F

AGREED FORM PRESS RELEASES

PRESS RELEASE — NON-UK VERSION

GW and Otsuka Announce Major Long Term Strategic Cannabinoid Alliance

London, UK; Princeton, NJ, USA; Tokyo, Japan; 14 February 2007 : GW Pharmaceuticals plc (AIM: GWP) and Otsuka Pharmaceutical Co., Ltd. today announce that they have entered into a major long term strategic cannabinoid alliance.

The relationship has commenced with the signing of an exclusive license and development agreement to develop and market Sativex ® , GW’s lead product, in the United States. The companies are also in detailed discussions with a view to entering into a cannabinoid research collaboration in the field of Central Nervous System (CNS) disorders and cancer treatment in order to research, develop and commercialize a range of other early stage cannabinoid product opportunities.

Sativex US License

Under the terms of the license agreement, GW has granted Otsuka an exclusive license to develop and market Sativex, GW’s lead product, in the US. GW will be responsible for the manufacture and supply of Sativex to Otsuka. The agreement is subject to Hart Scott Rodino clearance in the US.

The financial terms of this agreement include total milestone payments to GW of up to $273m as well as a long term commercial supply price and royalty. Otsuka will pay GW a signature fee of $18m. In addition, Otsuka will bear the costs of all US development activities for Sativex in the treatment of cancer pain, additional indications, and future formulations.

GW and Otsuka will jointly oversee all US clinical development and regulatory activities. For the first cancer pain indication, GW will be responsible for carrying out such activities, at Otsuka’s cost. GW will also continue to be the holder of the IND until the filing of a New Drug Application, which will be in Otsuka’s name. Otsuka will assume development and regulatory responsibility for the second and any subsequent indications.

In 2006, the Food & Drug Administration (FDA) permitted Sativex to enter directly into late stage development in the US for the treatment of pain in patients with advanced cancer that has not been adequately relieved by opioid medications. GW and Otsuka currently plan for the first US pivotal efficacy clinical trial to be a Phase II/III cancer pain dose ranging study, to commence this year.

million suffer pain. Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role.”

Cannabinoid Research Collaboration

Under the proposed cannabinoid research collaboration, which is currently under detailed discussion and is expected to be formalized in a separate agreement later in the year, Otsuka would fund the evaluation of a range of cannabinoids as drug candidates within the field of CNS and cancer treatment, with a view to selecting the most promising candidates for full clinical development, regulatory approval and global commercialization. Products selected for commercialization would be the subject of a license from GW. Under the terms of this license, Otsuka would fund the global development of selected products and GW would receive commercially reasonable financial terms.

The Otsuka Pharmaceutical Group has placed significant emphasis on the research of CNS disorders for the past 27 years. Otsuka’s lead product in the field of CNS ranks among the top seven product launches in industry history and the No. 1 product launch since 2002. Worldwide revenues from this product increased from $1.3bn in 2005 to over $1.9bn in 2006. The Group is privately owned, comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. It earned revenues of $6.8 billion in fiscal 2005, ranking it the 26th largest pharmaceutical company in the world(1). Otsuka is continuing to expand its CNS specialty sales force presence in the US.

Dr Geoffrey Guy, GW’s Chairman, said, “This agreement represents a landmark event in the history of GW. Not only have we secured the development and marketing of our lead product, Sativex, in the world’s largest market, we have also selected a strategic partner that will allow us to extend our cannabinoid pipeline. Otsuka has an excellent US commercial track record and a world leading CNS science base. We are delighted to be working with Otsuka to fulfill our ambition of developing a range of novel cannabinoid medicines to meet serious unmet medical needs.”

Taro Iwamoto, PhD, President & COO, Otsuka Pharmaceutical Development & Commercialization, Inc., said, “Otsuka is delighted to be entering into this strategic relationship with GW. Otsuka’s scientists consider cannabinoids to be a significant potential source of new medicines, and as world leading pioneers in this field, GW represents the ideal partner for Otsuka. Otsuka is committed to maximizing the potential of Sativex in the US market and looks forward to exploring a range of longer term cannabinoid product opportunities. We are confident that this is the beginning of a highly productive and valuable relationship for both companies.”

There will be a conference call for analysts today at 8.30am GMT. Analysts should contact Gemma Cross Brown at Financial Dynamics on +44 (0) 20 7831 3113 for details. There will be a live audio web cast of this call, which will be accessible on the press releases page in the investor relations section of the GW website (www.gwpharm.com). A recording of this call will be available on the GW website later today.

(1) Pharmaceutical Executive, May 2006

Enquiries:

For GW:
	GW Pharmaceuticals plc	Today: +44 20 7831 3113
	Dr Geoffrey Guy, Chairman	Thereafter: + 44 1980 557000
	Justin Gover, Managing Director
	Mark Rogerson, Press and PR	Tel: + 44 7885 638810

	Financial Dynamics	Tel: +44 20 7831 3113
	David Yates, Nicola Daley
For Otsuka:
	US Enquiries
	Debbie Kaufmann	Tel: +1 240 683 3568
	Europe Enquiries
	Alison Ross	Tel: +44 1895 207 7122
	Japan Enquiries
	Hideki Shirai	Tel: +81 3 3292 0021

Notes to Editors

About Otsuka Pharmaceutical Co., Ltd

Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: “Otsuka - people creating new products for better health worldwide.” Otsuka researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The Otsuka Pharmaceutical Group comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US $6.8 billion in consolidated annual revenues in fiscal 2005. The Group has R&D facilities in Japan (Osaka and Tokushima), EU (Frankfurt) and US (Rockville, MD). Its commercial operations are headquartered in US (Rockville, MD and Princeton, NJ), EU (UK) and Japan (Tokyo). For additional information, visit www.otsuka-global.com

About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products that alleviate pain and other neurological symptoms in patients who suffer from serious ailments. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. GW has to date entered into two additional Sativex license agreements — with Bayer HealthCare in the UK and Canada, and with Almirall in Europe (ex-UK). These agreements together provide payments to GW totaling up to £79m ($156m) as well as significant long term supply price provisions. For further information, please visit www.gwpharm.com

About Sativex

Sativex is an investigational product presented as a pump action oro-mucosal spray, which delivers a pharmaceutical formulation containing delta 9 tetrahydrocannabinol (THC) and cannabidiol (CBD). Each 100µL spray contains 2.7mg THC and 2.5mg CBD.

Sativex is standardized by both composition and dose and is supplied in small spray vials. Sativex is thought to act via cannabinoid receptors that are distributed throughout the central nervous system and in immune cells. These receptors are distributed throughout the pain

pathways of the nervous system, and their activation is known to reduce pain in relevant pain models.

Sativex showed positive results in a completed Phase III study in Europe in 177 patients with cancer pain. Patients in the study had advanced cancer and were experiencing pain that was not responding adequately to strong opioid medication (e.g. morphine). In addition to study medication, all patients remained on their existing opioid and other analgesic medication during the trial. In this study, Sativex achieved a statistically significant improvement in comparison with placebo in pain as measured on a numerical rating scale (p=0.014), a primary endpoint of the study. A responder analysis showed that approximately 40% of patients on Sativex showed a greater than 30% improvement in their pain (p=0.024).

Outside the US, Sativex is approved and marketed in Canada for the symptomatic relief of central neuropathic pain in Multiple Sclerosis, and is the subject of an ongoing regulatory submission in Canada for the relief of cancer pain. Sativex is also the subject of an ongoing regulatory application in four selected European countries for the symptomatic relief of spasticity in MS.

About Cannabinoids

The cannabinoid (CB) receptor system is a complex and far-reaching system which has only started to become understood in the last decade or so. To date, CB 1 and CB 2 receptors have been identified and cloned. Initially, the chemicals which affect these receptors (“cannabinoids”) were identified only within the cannabis plant, but extensive scientific investigation has now elaborated a series of endogenous chemicals which maintain this ‘endocannabinoid system’. These endogenous cannabinoids are produced in human tissues, exert their actions within those tissues and are then destroyed locally. This allows the system to function in a fine-tuning, modulatory role, and abnormalities of the endocannabinoid system have now been found in several important diseases. Originally, it was believed that these receptors acted largely within the brain, but it is becoming increasingly clear that they are present at many different sites, in many different body systems.

The importance of the integrity of this system of receptors in maintaining several critical areas of mental and physical well-being is becoming clearer because of the type of research that GW and its collaborators are performing. Equally, this research work has identified several important disease areas where the administration of cannabinoids as medicines may lead to desirable therapeutic consequences. Cannabinoid modulators are showing promise in chronic painful conditions, in movement disorders, and in disorders of cell proliferation such as cancer. Furthermore, the role of cannabinoids in the brain may offer a therapeutic promise in disorders of behaviour and mood. This is an area of active scientific discovery and therapeutic research which may deliver a range of new treatments to meet unmet medical needs.

( 1 ) Health Canada. “Approval of SATIVEX® with Conditions Fact Sheet.” Last accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html.

PRESS RELEASE — UK VERSION

GW and Otsuka Announce Major Long Term Strategic Cannabinoid Alliance

The Otsuka Pharmaceutical Group has placed significant emphasis on the research of CNS disorders for the past 27 years. Otsuka’s lead product in the field of CNS ranks among the top seven product launches in industry history and the No. 1 product launch since 2002. Worldwide revenues from this product increased from $1.3bn in 2005 to over $1.9bn in 2006. The Group is privately owned, comprises 87 companies and employs approximately 27,000 people in 17 countries and regions worldwide. It earned revenues of $6.8 billion in fiscal 2005, ranking it the 26th largest pharmaceutical company in the world(2). Otsuka is continuing to expand its CNS specialty sales force presence in the US.

Sativex US License

(2) Pharmaceutical Executive, May 2006

the first US pivotal efficacy clinical trial to be a Phase II/III cancer pain dose ranging study, to commence this year.

Commenting on Sativex, Dr. Russell K. Portenoy, Chairman of the Department of Pain Medicine and Palliative Care at Beth Israel Medical Center in New York City, and principal investigator of the first planned US Sativex study said, “A previous Phase III clinical study showed that Sativex achieved a statistically significant improvement in pain relief in terminally ill cancer patients. There are 3.9 million cancer patients in the US, of which 2.5 million suffer pain. Although opioids are highly effective analgesics, studies suggest that as many as one-third of patients with pain due to advanced cancer do not obtain adequate relief and new treatments are needed. Cannabinoid formulations may represent an important option in the future and the information obtained from clinical trials of Sativex will be critical in defining their role.”

Cannabinoid Research Collaboration

Enquiries:

For GW:
	GW Pharmaceuticals plc	Today: +44 20 7831 3113
	Dr Geoffrey Guy, Chairman	Thereafter: + 44 1980 557000

	Justin Gover, Managing Director
	Mark Rogerson, Press and PR	Tel: + 44 7885 638810

	Financial Dynamics	Tel: +44 20 7831 3113
	David Yates, Nicola Daley
For Otsuka:
	US Enquiries
	Debbie Kaufmann	Tel: +1 240 683 3568
	Europe Enquiries
	Alison Ross	Tel: +44 1895 207 7122
	Japan Enquiries
	Hideki Shirai	Tel: +81 3 3292 0021

Notes to Editors

About Otsuka Pharmaceutical Co., Ltd

About GW

GW was founded in 1998 and listed on the AiM, a market of the London Stock Exchange, in June 2001. Operating under license from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products that alleviate pain and other neurological symptoms in patients who suffer from serious ailments. GW has assembled a team of over 100 scientists with extensive experience in developing both plant-based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field. GW has to date entered into two additional Sativex license agreements — with Bayer HealthCare in the UK and Canada, and with Almirall in Europe (ex-UK). These agreements together provide payments to GW totaling up to £79m ($156m) as well as significant long term supply price provisions. For further information, please visit www.gwpharm.com

About Sativex

About Cannabinoids

The cannabinoid (CB) receptor system is a complex and far-reaching system which has only started to become understood in the last decade or so. To date, CB 1 and CB 2 receptors have been identified and cloned. Initially, the chemicals which affect these receptors (“cannabinoids”) were identified only within the cannabis plant, but extensive scientific investigation has now elaborated a series of endogenous chemicals which maintain this ‘endocannabinoid system’. These endogenous cannabinoids are produced in human tissues, exert their actions within those tissues and are then destroyed locally. This allows the system to function in a fine-tuning, modulatory role, and abnormalities of the endocannabinoid system have now been found in several important diseases. Originally, it was believed that these receptors acted largely within the brain, but it is becoming increasingly clear that they are present at many different sites, in many different body systems.

Health Canada. “Approval of SATIVEX® with Conditions Fact Sheet.” Last accessed 16 December 2005. Available at http://www.hc-sc.gc.ca/dhp-mps/prodpharma/notices-avis/conditions/sativex_factsheet_e.html.

EXHIBIT G

JAPANESE TAX AUTHORITY FORMS

[ Page intentionally left Blank ]

EXHIBIT H

FORM OF IND, NDA, FDA REGULATORY APPROVAL AND DEA REGULATORY
APPROVAL TRANSFER LETTERS

A. DEA REGULATORY APPROVALS

[Letterhead of Otsuka Pharmaceutical Co., Ltd. or its sublicense, as appropriate]

Drug Enforcement Administration

Office of Diversion Control

2401 Jefferson Davis Highway

Alexandria, VA 22301

[insert date]

Dear Sirs

OTSUKA PHARMACEUTICAL CO., LTD hereby cancels and terminates the DEA Registration(s) as set out in Schedule 1 hereto.

OTSUKA PHARMACEUTICAL CO., LTD has transferred all ownership, rights and obligations in the Food & Drug Administration approvals corresponding to the Product(s) registered with the DEA (as set out Schedule 1) to GW Pharma Limited of Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom .

GW Pharma Limited will contact the Drug Enforcement Administration separately regarding the DEA registrations for the Product(s) going forward.

Yours faithfully

For and on behalf of

OTSUKA PHARMACEUTICAL CO., LTD

SCHEDULE 1

DEA Registration Number	Product Name and Description	IND/NDA/FDA Regulatory Approval Reference

B. INDs AND NDAs

[Letterhead of Otsuka Pharmaceutical Co., Ltd. or its sublicense, as appropriate]

Center for Drug Evaluation and Research

Food and Drug Administration

5901-B Ammendale Road

Beltsville, Maryland 20705

[insert date]

Dear Sirs

Assumption of ownership of IND(s) and NDA(s)

OTSUKA PHARMACEUTICAL CO., LTD has transferred all ownership, rights and obligations of the IND(s) and NDA(s) as set out in Schedule 1 hereto to GW Pharma Limited of Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom .

GW Pharma Limited commits to the conditions set by the Food and Drug Administration contained in the IND(s) and NDA(s) and has a complete copy of the IND(s) and NDA(s), including all supplements and records.

GW Pharma Limited will write to the Food and Drug Administration shortly with details of who should be contacted regarding the IND(s) and NDA(s) from the date of this letter.

Yours faithfully

For and on behalf of

OTSUKA PHARMACEUTICAL CO., LTD

SCHEDULE 1

IND/NDA Number		Product Name and Description

C. FDA REGULATORY APPROVALS

[Letterhead of Otsuka Pharmaceutical Co., Ltd. or its sublicense, as appropriate]

Center for Drug Evaluation and Research

Food and Drug Administration

5901-B Ammendale Road

Beltsville, Maryland 20705

[insert date]

Dear Sirs

Assumption of ownership of approved NDA(s)

OTSUKA PHARMACEUTICAL CO., LTD has transferred all ownership, rights and obligations of the NDA(s) approved by the FDA as set out in Schedule 1 hereto (each an “ Approved NDA ”) to GW Pharma Limited of Porton Down Science Park, Salisbury, Wiltshire, SP4 0JQ, United Kingdom, such transfer to be effective as of [insert date] (the “ Effective Date ”).

From the Effective Date GW Pharma Limited commits to the conditions set by the Food and Drug Administration contained in the Approved NDA(s) and has a complete copy of the Approved NDA(s), including all supplements and records.

GW Pharma Limited will write to the Food and Drug Administration shortly with details of who should be contacted regarding the Approved NDA(s) from the date of this letter.

Yours faithfully

For and on behalf of

OTSUKA PHARMACEUTICAL CO., LTD

SCHEDULE 1

Approved NDA		Product Name and Description

Exhibit 10.20

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

AMENDMENT NO. 1

TO THE

DEVELOPMENT AND LICENSE AGREEMENT

between

GW PHARMA LTD

and

OTSUKA PHARMACEUTICAL CO., LTD

and

GW PHARMACEUTICALS PLC

THIS AMENDMENT NO. 1 (“Amendment”) to that certain Development and License Agreement dated February 14, 2007 by and among the parties hereto (“Agreement”), is made and entered into as of November 1, 2008 (“Amendment Effective Date”), by and among GW Pharma Ltd a corporation organized and existing under the laws of England having offices at Porton Down Science Park, Salisbury, Wiltshire, SP4 OJQ, United Kingdom on behalf of itself and its Affiliates (collectively “GW Pharma” ), GW Pharmaceuticals Plc, a company organized under the laws of England, having offices at Porton Down Science Park, Salisbury, Wiltshire, SP4 OJQ, United Kingdom and Otsuka Pharmaceutical Co., Ltd., a corporation organized and existing under the laws of Japan, having a principal place of business at 2-9, Kanda Tsukasamachi, Chiyoda-ku, Tokyo, 101-8535 Japan ( “Otsuka” ).

RECITALS

WHEREAS, Otsuka, GW Pharma and GW Phaimaceuticals Plc have previously entered into the Agreement;

WHEREAS, Otsuka, GW Pharma and GW Pharmaceuticals Plc now desire to amend and supplement certain terms and conditions of the Agreement as hereinafter specified;

WHEREAS, Otsuka, GW Pharma and GW Pharmaceuticals Plc desire that all other terms and conditions of the Agreement remain in full force and effect;

NOW, THEREFORE, for good and valuable consideration, the receipt and adequacy of which are hereby acknowledged, Otsuka, GW Pharma and GW Pharmaceuticals Plc agree as follows:

1. Capitalized terms in this Amendment shall have the same meaning as those in the Agreement, unless specifically defined otherwise in this Amendment. All Article and Section references are in regard to the Agreement. References to the term “Agreement” in the Agreement shall be deemed to include this Amendment.

2. Except as expressly modified herein, the Agreement shall remain in full force and effect in accordance with its terms. To the extent that there are any inconsistencies between this Amendment and the Agreement, the terms of this Amendment shall supersede the Agreement.

3. The following defined terms shall be added to Article 1 of the Agreement:

“ Allocable Research Overhead ” shall mean an amount added to an item of cost to reflect a directly related overhead incurred by a Party or for its account in relation to such item of cost, including occupancy costs, heating, lighting and power costs, information system costs, payroll processing costs (in each case based on space occupied or headcount or other activity-based method consistently applied) and fairly allocated costs of calibrating and maintaining equipment, but excluding such things as general and administrative and legal expenses (other than research administration expenses) and costs that do not involve a cash outlay.

“ FTE ” shall mean a full time equivalent person year equal to at least two hundred and twenty seven (227) working days per year of work carried out by an employee of GW Pharma.

“ FTE Costs ” shall mean the cost of FTEs at the FTE Rate.

“ FTE Rate ” shall mean the internal cost of a single FTE of GW Pharma per year performing pursuant to the Development Plan. The FTE Rate for a GW Pharma employee fairly allocated to the Development Plan shall reflect to the extent relating to performance of a Development Plan (i) the fully burdened internal costs of such FTE including all employee-related compensation, including but not limited to, salaries, wages, bonuses, benefits, and any other employment costs, including subsistence costs, training, recruiting, relocation, professional dues and other costs together with (ii) related Allocable Research Overhead and (iii) the cost of general consumables used by such FTE, both (ii) and (iii) fairly allocated to such FTE.

4. Section 4.2 of the Agreement shall be replaced in its entirety with the following:

4.2. Estimated Development Costs. The budget set forth in the First Indication Development Plan (the “Development Budget”) shall set out the Third Party costs AND FTE COSTS projected to be incurred by GW Pharma in the performance of its obligations under such Development Plan (including the cost to GW Pharma of relevant clinical trial insurance) other than the costs to GW Pharma of generating the CMC Data (“Development Costs”). The Development Budget shall estimate the Development Costs to be incurred by GW Pharma for each calendar quarter of each calendar year covered by such Development Budget. GW Pharma shall submit the first invoice in respect of GW Pharma’s estimated Development

Costs from the Closing Date until the end of the first full calendar quarter after the Closing Date to Otsuka as soon as practicable following the Closing Date and this first invoice shall be payable within ten (10) days of its submission. Otsuka shall, upon receipt of GW Pharma’s invoices (other than for this first period) at least 30 days in advance, pay to GW Pharma GW Pharma’s estimated Development Costs for such calendar quarter by the 1st day of such calendar quarter. GW Pharma shall submit to Otsuka via the JDC a progress report and to Otsuka itself copies of invoices paid by GW during such calendar quarter to Third Parties for the performance of Development Plan activities within ten (10) days of the end of each such calendar quarter or within forty-eight (48) hours of their receipt from the Third Party, if later. Each progress report shall, without limitation, set forth in respect of clinical studies managed or conducted by GW Pharma under the Development Plan, the number of screened subjects, the number of enrolled subjects, the number of withdrawn or discontinued subjects, the number of completed subjects and such other information as may be reasonably requested by Otsuka. Pre-clinical studies conducted or managed by GW Pharma under the Development Plan and paid by Otsuka shall become a subject of the progress report due following the calendar quarter in which such pre-clinical study was completed. In respect of any such pre-clinical study, the progress report shall include the study report for such pre-clinical study and copies of all invoices paid by GW to Third Parties in respect of the performance of such pre-clinical study. The Parties shall discuss and agree any other information or data to be included in the format for the progress report.

In the event the JDC or JCC (as applicable under Section 3.7.) make any change to the First Indication Development Plan resulting in an increase or decrease in Development Costs, the JDC or JCC (as applicable) shall also make corresponding changes to the Development Budget for the First Indication and the payments to be made to GW Pharma pursuant to this Section 4.2 shall be increased or decreased accordingly to reflect the change in the Development Budget for the First Indication. If during the course to the First Indication Development Plan, either Party comes to believe that Development Costs for the First Indication are likely to exceed by ***% or more the estimated Development Costs, such Party shall notify the relevant JDC sub-committee at its next meeting, together with the reasons for the same. GW Pharma shall not incur amounts in excess of such *** per cent. (***%) without the consent of the JDC. Upon approval by the JDC, the Development Budget (and payments made to GW Pharma under this Section 4.2 shall be amended to reflect the decision of the JDC in respect of such increase or decrease to the Development Budget. Any clinical trial agreements performed by or on behalf of GW Pharma for which Otsuka is obligated to pay pursuant to this Agreement shall contain a provision requiring the return of funds advanced to any clinical site or clinical investigator in respect of services not actually performed. GW Pharma shall conduct each pre-clinical study and each clinical study for which it is responsible under this Agreement or a Development Plan or require each pre-clinical research

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

organization or clinical research organization, as the case may be, engaged for such purposes to conduct each such pre-clinical study in accordance with GLP and each clinical study in accordance with GCP. Clinical trial insurance obtained by GW Pharma for the conduct of clinical trials under the First Indication Development Plan shall include Otsuka as an additional named insured.

5. Section 4.3 of the Agreement shall be replaced in its entirety with the following:

4.3 Actual Development Costs . In the event actual Development Costs paid by GW Pharma to Third Parties OR INCURRED BY GW PHARMA AS FTE COSTS in a calendar quarter exceed the estimated Development Costs paid by Otsuka to GW Pharma for such quarter (including any surplus Development Cost payment previously made by Otsuka to GW Pharma and carried over from a previous quarter) as documented in a progress report (including invoices) supporting the excess of actual over estimated Development Costs for such calendar quarter, Otsuka shall, within thirty (30) days of its receipt of an invoice for the excess difference from GW Pharma, pay GW Pharma an amount equal to the excess difference of actual over estimated Development Costs.

In the event actual Development Costs paid by GW Pharma to Third Parties OR INCURRED BY GW PHARMA AS FTE COSTS in a calendar quarter fall below the estimated Development Costs paid by Otsuka to GW Pharma for such quarter (including any surplus Development Cost payment previously made by Otsuka to GW Pharma and carried over from a previous quarter) as documented in a progress report

(including invoices) supporting such overpayment by Otsuka of Development Costs for such calendar quarter, GW Pharma shall reduce the next estimated Development Cost payment invoiced to Otsuka hereunder by the entire amount of Otsuka’s overpayment. If Otsuka’s overpayment exceeds the next estimated Development Cost payment, GW Pharma shall subtract the full amount of any such remaining overpayment from successive invoices to Otsuka for Development Costs. If, at the completion of the Development Plan, any overpayment by Otsuka of estimated over actual Development Costs remains, GW Pharma shall promptly return such overpayment to Otsuka.

6. The JDC decided at its October 29, 2008 meeting that GW Pharma will be responsible for the conduct of *** in accordance with the First Indication Development Plan and the Agreement (the “Study”). In connection with GW Pharma’s conduct of the Study, the Parties have further agreed as follows in respect of enrollment targets and milestone payments due under Section 4.12 of the Agreement:

(a) In the event GW Pharma has enrolled *** or more subjects into the Study in Study Countries by ***, then there will be no change to milestone payments Otsuka shall pay to GW Pharma under Section 4.12 of the Agreement.

(b) If by *** enrollment into the Study in Study Countries is in a range between *** subjects or fewer, the next milestone payment due and payable by

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Otsuka to GW Pharma under Section 4.12 shall be reduced by the amount indicated in the following table:

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or fewer subjects		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

(c) In the event the Study is completed or terminated by decision of the JDC with an effective date on or prior to ***, then the enrollment target for the Study will be *** enrolled subjects. In the event that upon *** fewer than *** subjects have been enrolled, then the provisions of Sections 6 (b), (d), (e), (0, (g) and (h) of this Amendment shall not apply and the next milestone payment due and payable by

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Otsuka to GW Pharma under Section 4.12 of the Agreement shall be reduced by the amount indicated in the following table:

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or more subjects		***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

(d) In the event the Study is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects. In the event that upon *** fewer than *** subjects have been enrolled, then the provisions of Sections 6 (b), (c), (e), (f), (g) and (h) of this Amendment shall not apply and the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Agreement shall be reduced by the amount indicated in the following table:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or more subjects		***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

(e) In the event the Study is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects. In the event that upon *** fewer than *** subjects have been enrolled, then the provisions of sections 6 (b), (c), (d), (f), (g) and (h) of this Amendment shall not apply and the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Agreement shall be reduced by the amount indicated in the following table:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or more subjects		***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

(f) In the event the Study is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects. In the event that upon *** fewer than *** subjects have been enrolled, then the provisions of Sections 6 (b), (c), (d), (e), (g) and (h) of this Amendment shall not apply and the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Agreement shall be reduced by the amount indicated in the following table:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or more subjects		***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

less than *** subjects (inclusive)		US $***

(g) In the event the Study is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects. In the event that upon *** fewer than *** subjects have been enrolled, then the provisions of Sections 6 (b), (c), (d), (e), (f) and (h) of this Amendment shall not apply and the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Agreement shall be reduced by the amount indicated in the following table:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or more subjects		***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

less than *** subjects (inclusive)		US $***

(h) In the event the Study is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects. In the event that upon ***fewer than *** subjects have been enrolled, then the provisions of Sections 6 (b), (c), (d), (e), (f) and (g) of this Amendment shall not apply and the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Agreement shall be reduced by the amount indicated in the following table:

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Total Study Enrollment is:		Amount of Milestone Reduction:

*** or more subjects		***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

between * and * subjects (inclusive)		US $***

less than *** subjects (inclusive)		US $***

(i) In any of the events described in Sections 6 (b) through (h) of this Amendment, Otsuka is entitled to receive the full milestone reduction indicated. To this end, in the event any milestone payment required to be made by Otsuka to GW Pharma under Section 4.12 is for any reason insufficient to give Otsuka the full reduction to which it is entitled, successive milestone payments may be reduced by an amount(s) necessary to enable Otsuka to receive the full benefit of the reduction to which it is entitled.

7. As of the Amendment Effective Date each Party hereby represents and warrants to, and covenants with, the other Party that it (i) has the power and authority and the legal right to enter into this Amendment and to perform its obligations hereunder and (ii) has

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

taken all necessary action on its part to authorize the execution and delivery of this Amendment and the performance of its obligations hereunder. This Amendment has been duly executed and delivered on behalf of such Party and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.

8. This Amendment shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, without regard to its choice of law provisions.

9. This Amendment may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

IN WITNESS WHEREOF, Otsuka and GW Pharma have executed and delivered this Amendment as of the Amendment Effective Date set forth above.

For GW Pharma Ltd		For Otsuka Pharmaceutical Co., Ltd.


/s/ David F Kirk		/s/ Kazumichi Kobayashi

Name: David F Kirk		Name: Kazumichi Kobayashi

Title: Finance Director		Title: Senior Operating Officer


GW Pharmaceuticals Plc


/s/ Justin Gover

Name: Justin D Gover

Title: Managing Director

Exhibit 10.21

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406



Otsuka Pharmaceutical Co., Ltd	Justin Gover
Licensing Department	Managing Director
3-2-27, Otedori Chuo-ku,
Osaka 540-0021 Japan	1 Cavendish Place
Attention: Director	London W1G 0QD

Legal Affairs Department	E-mail: jdg@gwpharm.com
Shinagawa Grand Central Tower,	Tel: +44 (0)20 7291 0555
2-16-14, Konan	Fax: +44 (0)20 7291 0550
Minato-ku
Tokyo, 108-8242 Japan
Attention: Director

21 October 2010

Dear Sirs

Development and License Agreement dated February 14, 2007 (the “Development and License Agreement”) by and among GW Pharma Ltd and its Affiliates (collectively “GW Pharma”), GW Pharmaceuticals Plc, and Otsuka Pharmaceutical Co., Ltd. (“Otsuka”)

On November 1, 2008, GW Pharma, GW Pharmaceuticals and Otsuka entered into the first amendment to the Development and License Agreement (“Amendment No. 1”).

Section 6(f) of Amendment No. 1 states that in the event that (i) the Study (as defined in Amendment No. 1) is completed or terminated by decision of the JDC with an effective date between *** and *** (inclusive), then the enrollment target for the Study will be *** enrolled subjects, and (ii) *** fewer than *** subjects have been enrolled in the Study, (a) the provisions of Sections 6 (b), (c), (d), (e), (g) and (h) of Amendment No. I shall no longer apply and (b) the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Development and License Agreement shall be reduced according to the number of patients actually enrolled into the Study.

At the JDC meeting which was held on September 23, 2009 the JDC decided to stop opening new clinical investigation sites as part of the Study. The Parties have agreed that this decision of the JDC qualifies as a decision to terminate the Study for the purposes of Section 6(f) of Amendment No. 1.

As the foregoing decision was a decision reached by the JDC with an effective date between *** and *** and as fewer than *** subjects had been enrolled into the Study on ***, pursuant to Section 6(f) of Amendment No. 1 there should therefore be a reduction of US $*** in the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Development and License Agreement.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Notwithstanding the provision of Section 6 (f), subsequent to the JDC meeting which was held on September 23, 2009 the Parties have agreed that the next milestone payment due and payable by Otsuka to GW Pharma under Section 4.12 of the Development and License Agreement (being the payment of US$*** upon first administration of the Existing Licensed Product in a Phase III Clinical Study designed to support filing of the NDA for the First Indication pursuant to Section 4.12(a) of the Development and License Agreement) shall be reduced by US$***.

We therefore believe that:

(i) Section 4.12(a) of the Development and License Agreement is amended to read as follows:

“US$*** upon first administration of the Existing Licensed Product in a Phase III Clinical Study designed to support filing of the NDA for the First Indication”; and

(ii) Section 6 of Amendment No.1 no longer applies and is of no further effect.

Capitalized terms undefined in this letter agreement shall bear the meanings as provided in Section 1.1 of the Development and License Agreement unless otherwise specified.

If you agree with to the terms as set out above, please evidence your agreement to the terms as set out above by signing where indicated below on both originals and return one original execution copy to us, retaining the other original execution copy for your records.

Yours faithfully


/s/ Justin Gover
For and on behalf of
GW Pharma Limited
Name: Justin Gover
Title: Managing Director


Agreed by Otsuka Pharmaceutical Co., Ltd.:


/s/ Kazumichi Kobayashi
Otsuka Pharmaceutical Co, Ltd
Name: Kazumichi Kobayashi
Title: Senior Operating Officer, Deputy General Manager
Date: December 3, 2010

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.22

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Execution Copy

DISTRIBUTION AND LICENSE AGREEMENT

BY AND BETWEEN

GW PHARMA LTD

AND

NOVARTIS PHARMA AG

TABLE OF CONTENTS

1.	DEFINITIONS AND INTERPRETATION	3

2.	LICENSES AND OTHER GRANTS	12

3.	GOVERNANCE	15

4.	DEVELOPMENT AND PRODUCT INFORMATION	17

5.	SUPPLY OF PRODUCT TO NOVARTIS	19

6.	REGULATORY AFFAIRS AND COMMERCIALIZATION	19

7.	FINANCIAL PROVISIONS	26

8.	INTELLECTUAL PROPERTY	34

9.	CONFIDENTIALITY	38

10.	TERM AND TERMINATION	41

11.	EFFECTS OF TERMINATION	43

12.	REPRESENTATIONS, WARRANTIES AND COVENANTS	45

13.	INDEMNIFICATION; LIABILITY	49

14.	GENERAL PROVISIONS	51

Exhibit A: GW Technology and GW Trademarks

Exhibit B: Sativex

Exhibit C: Territory

Exhibit D: LATAM

Exhibit E: Form of Invoice

Exhibit F: Key Manufacturing and Supply Terms

DISTRIBUTION AND LICENSE AGREEMENT

This Distribution Agreement ( “Agreement” ) is entered into as of 8th April 2011 ( “Effective Date” ) by and between GW Pharma Ltd, a company incorporated under the laws of England and Wales (Company No. 03704998), whose registered office is at Porton Down Science Park, Wiltshire SP4 03Q (hereinafter referred to as “GW” ) and Novartis Pharma AG, a company incorporated under the laws of Switzerland, with a place of business at Lichtstrasse 35, Basel, CH-4002 Switzerland, (hereinafter referred to as “Novartis” ). GW and Novartis may hereinafter be referred to individually as a “Party” and collectively as the “Parties” .

WHEREAS, GW and its Affiliates have developed, and have the rights to promote, market, sell and/or otherwise distribute, Products in the Territory;

WHEREAS, Novartis is engaged in the business of pharmaceutical manufacturing, clinical testing, importation, and distribution and has the capability, experience, facilities and resources to import, distribute, and sell Products in the Territory; and

WHEREAS, Novartis wishes, and GW is willing to appoint Novartis, to package and label Botanical Drug Products and test, import, distribute and sell the resulting Products in the Territory in accordance with the terms of this Agreement.

NOW, THEREFORE, in consideration of the mutual covenants and agreements herein contained, GW and Novartis agree as follows:

1. DEFINITIONS AND INTERPRETATION

1.1 Definitions. For the purposes of this Agreement, the following terms will have the following meanings:

“Accounting Standards” means, with respect to each Party, the IFRS (International Financial Reporting Standards), in each case, as generally and consistently applied throughout such Party’s organization.

“Affiliate” means, with respect to a Party, any Person that controls, is controlled by, or is under common control with that Party. For the purpose of this definition, “control” shall mean direct or indirect ownership of fifty percent (50%) or more of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or fifty percent (50%) or more of the equity interest in the case of any other type of legal entity, status as a general partner in any partnership, or any other arrangement whereby the entity or person controls or has the right to control the board of directors or equivalent governing body of a corporation or other entity, or the ability to cause the direction of the management or policies of a corporation or other entity. In the case of entities organized under the Laws of certain countries, the maximum percentage ownership permitted by law for a foreign investor may be less than fifty percent (50%), and in such case such lower percentage shall be substituted in the preceding sentence, provided that such foreign investor has the power to direct the management and policies of such entity.

“Alliance Manager” has the meaning set forth in Section 3.1.

“Almirall” means Almirall, S.A. a company incorporated in Spain whose principal place of business is General Mitre 151, 08022 Barcelona, Spain.

“Almirall Agreement” means the Product Commercialisation and Supply Consolidated Agreement effective 6 June, 2006, between GW and Almirall.

“Almirall Territory” means Albania, Andorra, Austria, Belgium, Bosnia-Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Macedonia, Monaco, Norway, Poland, Portugal, Romania, San Marino, Serbia and Montenegro, Slovakia, Slovenia, Spain, Sweden, Switzerland, The Netherlands, Turkey and the Vatican City. For clarity the Almirall Territory does not include Great Britain, Northern Ireland, the Channel Islands or the Isle of Man.

“Back-up Product” means a pharmaceutical product containing the Botanical Drug Substances as the sole active ingredients (as identified in the relevant Marketing Approval) but in a ratio which is different from Sativex *** (i) spasticity in MS, (ii) cancer pain or (iii) any other indication for which Sativex receives a Marketing Approval from a Regulatory Authority during the Term.

“Baseline Sales” means, on a country-by-country basis, the aggregate Net Sales of Product sold by Novartis, its Affiliates and Sublicensees in such country in the twelve (12) consecutive months immediately preceding the first arm’s length sale of any Competitive Product by a Third Party for use or consumption in such country.

“Botanical Drug Product” or “BDP” means fully formulated bulk, vialled Product comprised of BDS and excipients (i.e. propylene glycol, ethanol and peppermint flavoring) filled into 10ml vials ready to be packaged and labeled.

“Botanical Drug Substances” or “BDS” means *** liquid carbon dioxide extracts of a chemically and genetically characterized cannabis plant, (i) in one case containing *** as the principal cannabinoid and (ii) in the other case containing *** as the principal cannabinoid.

“Botanical Raw Material” or “BRM” means the dried aerial parts, harvested at the end of the flowering period, of *** of *** bred to maximise yield and dominance for a specific cannabinoid (either *** or ***). Each BRM yields *** type of BDS.

“Business Day” means a day which is not a Saturday, Sunday or a public holiday in the UK or in Switzerland.

“CBD” means cannabidiol and cannabidiolic acid.

“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on 31st March, 30th June, 30th September and 31st December.

“Calendar Year” means a period of twelve (12) consecutive calendar months ending on 31st December.

“Change of Control” means any of the following events: (a) any Third Party (or group of Third Parties acting in concert) becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the total voting power of the stock then outstanding of GW normally entitled to vote in elections of directors; (b) GW consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into GW, in either event pursuant to a transaction in which more than fifty percent (50%) of the total voting power of the stock outstanding of the surviving entity normally entitled to vote in elections of directors is not held by the parties holding at least fifty percent (50%) of the outstanding shares of GW preceding such consolidation or merger; or (c) GW conveys, transfers or leases all or substantially all of its assets to any Third Party.

“Claims” means all Third Party demands, claims, actions, proceedings and liability (whether criminal or civil, in contract, tort or otherwise) for losses, damages, reasonable legal costs and other reasonable expenses of any nature whatsoever.

“Commercialize” means to market, promote, distribute, import, export, offer to sell and/or sell Product and/or conduct other Commercialization activities, and “Commercialization” means commercialization activities relating to Product, including activities relating to marketing, promoting, distributing, importing, exporting, offering for sale and/or selling Product, customer service and support, and Phase IV clinical studies conducted for purposes other than obtaining or maintaining any Marketing Approval.

“Commercialization Plan” means the annual plan for the Commercialization of Products in the Key Countries and the rest of the Territory as a whole prepared by Novartis for its own purposes and in accordance with its procedures and protocols, the content of which shall be determined by Novartis in its sole discretion from time to time, which plan shall include Novartis’ then-current forecasts for sales of the Products in the Field in the Territory, marketing strategy plans for Product launch, planned promotional activities with respect to the Products in the Field in the Territory.

“Commercially Reasonable Efforts” means the expenditure of those efforts and resources used consistent with the usual practice of Novartis in pursuing the Regulatory Approval and commercialization of its other pharmaceutical products with similar market potential in the Territory to Product, including through the appointment of Sublicensees and Subcontractors.

“Competitive Product” means any botanical or synthetically derived product, other than a Product, that contains a combination of *** and *** as the *** principal cannabinoids, for use in the treatment of spasticity in MS, cancer pain or any other indication for which Sativex receives a Market Approval from a Regulatory Authority during the Term.

“Confidential Information” means all know-how and other proprietary information and data including that of a financial, commercial or technical nature which the disclosing Party or any of its Affiliates has supplied or otherwise made available to the other Party or its Affiliates, whether made available orally, in writing or in electronic form, including information comprising or relating to plans, strategies, concepts, discoveries, inventions, data, designs or formulae in relation to the Product or this Agreement.

“Control” or “Controlled” means, with respect to any Know How, Patent Rights, other intellectual property rights, or any proprietary or trade secret information, the legal authority or right (whether by ownership, license or otherwise) of a Party to grant a license or a sublicense of or under such Know How, Patent Rights, or intellectual property rights to another Person, or to otherwise disclose such proprietary or trade secret information to another Person, without breaching the terms of any agreement with a Third Party, or misappropriating the proprietary or trade secret information of a Third Party.

“Develop” or “Development” means all drug development activities, including test method development and stability testing, assay development and audit development, toxicology, formulation, quality assurance/quality control development, statistical analysis, clinical studies (other than Phase IV clinical studies conducted for purposes other than obtaining or maintaining any Marketing Approval), and expressly excluding packaging development, and the preparation, filing and prosecution of applications for Marketing Approval (and other Regulatory Approvals).

“eCTD” means electronic common technical document.

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“EMA” means the European Medicines Agency or any successor entity thereto.

“Encumbrance” means any claim, charge, equitable interest, hypothecation, lien, mortgage, pledge, option, license, assignment, power of sale, retention of title, right of pre-emption, right of first refusal or security interest of any kind.

“European Union” means the European Union Member States as they exist from time to time.

“Exclusive Negotiation Period” means, subject to Section 2.5(b), the period commencing on *** and ending on ***.

“Extreme Supply Failure” means the failure by GW to deliver any amount of Novartis’ properly forecast and ordered (in accordance with the Manufacturing and Supply Agreement) requirement of BDP or BDS (as applicable in the circumstances) (excluding any delivery of deviations or non-conforming Product) over six (6) consecutive deliveries.

“Field” means treatment, prevention and diagnosis of all indications in humans and animals.

“First Commercial Sale” means, with respect to any Product, the first arm’s length sale to a Third Party for use or consumption of any such Product in a country.

“GW Patents” means the Patent Rights within GW Technology.

“GW Technology” means the Patent Rights identified on the attached Exhibit A and all other Patent Rights, plant breeders’ rights/plant variety rights, industrial design rights and similar rights, and Know-How Controlled by GW or its Affiliates as of the Effective Date or thereafter during the Term, including any Resulting Intellectual Property owned or Controlled by GW, that are reasonably necessary or useful for (i) the use, or Commercialization of any Product in the Field in the Territory and/or (ii) in the instance where Novartis is granted a license pursuant to Section 2.1(b) only, the manufacture of BDP. For clarity, GW Technology does not include the Otsuka Patents.

“GW Trademarks” means the name Sativex and associated trademarks identified on Exhibit A , and any other trademarks, trade names, service marks, whether registered or unregistered, and all applications for the same, that GW registers to use, specifically in connection with the Product in the Territory pursuant to Section 6.3(a).

“Insolvency Event” means, in relation to either Party, any one of the following: (a) that Party becomes insolvent; (b) that Party is the subject of voluntary or involuntary bankruptcy proceedings instituted on behalf of or against such Party (except for involuntary bankruptcy proceedings which are dismissed within sixty (60) days); (c) an administrative receiver, receiver and manager, interim receiver, custodian, sequestrator or similar officer is appointed in respect of that Party; (d) a notice shall have been issued to convene a meeting for the purpose of passing a resolution to wind up that Party, or such a resolution shall have been passed other than a resolution for the solvent reconstruction or reorganization of that Party; (e) a resolution shall have been passed by that Party or that Party’s directors to make an application for an administration order or to appoint an administrator; or (f) that Party takes any step (including starting negotiations) with a view to readjustment, rescheduling or deferral of any part of that Party’s indebtedness, or proposes or makes any general assignment, composition or arrangement with or for the benefit of all or some of that Party’s creditors or makes or

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suspends or threatens to suspend making payments to all or some of that Party’s creditors or the Party submits to any type of voluntary arrangement.

“Insolvency Officer” shall mean a receiver, administrative receiver, administrator, liquidator, trustee, nominee or supervisor in respect of a company voluntary arrangement or scheme of arrangement or any other similar official that it would be possible to appoint under applicable insolvency law to or over the assets of a company or other legal entity.

“Insolvency Proceeding” shall mean in respect of a company or other legal entity (i) the appointment of an Insolvency Officer or (ii) such company or legal entity becoming subject to a company voluntary arrangement, a scheme of arrangement or other composition or arrangement with or for the benefit of all or substantially all of such entity’s creditors.

“Intellectual Property” means any of the following rights in any jurisdiction: (1) patents and patent applications, industrial design rights and similar rights; (2) trademarks, service marks, trade dress, corporate, trade, and business names, domain names, and other indicia of origin whether registered or unregistered, and all applications for the same and all associated goodwill; (3) all works of authorship, whether registered as copyrights or unregistered, all pending applications for the same and all associated moral rights and special rights of authorship; and (4) Know-How, trade secrets or other proprietary and confidential information.

“Joint Steering Committee” or “JSC” means the committee established as set forth in Section 3.2.

“Key Countries” means ***.

“Know-How” means all technical information, know-how and data, including inventions (whether patentable or not), discoveries, trade secrets, specifications, instructions, processes, formulae, materials, expertise and other technology applicable to compounds, formulations, compositions, products or to their manufacture, development, registration, use or commercialization or methods of assaying or testing them or processes for their manufacture, formulations containing them, compositions incorporating or comprising them and including all biological, chemical, pharmacological, biochemical, toxicological, pharmaceutical, physical and analytical, safety, quality control, manufacturing, preclinical and clinical data, instructions, processes, formulae, expertise and information, regulatory filings and copies thereof, relevant to the development, manufacture, use or commercialization of and/or which may be useful in studying, testing, development, production or formulation of products, or intermediates for the synthesis thereof.

“LATAM Region” means each of the countries listed on Exhibit D to this Agreement.

“Launch” means with respect to any country in the Territory, the date following Marketing Approval in such country on which Novartis, its Affiliates, Sublicensees or Subcontractors commence (i) active detailing of the first Product to medical professionals in a country with prescribing authority; and/or (ii) active advertising and promotion of the first Product, to the extent permitted by applicable Laws in the country in question.

“Laws” shall mean all laws, statutes, rules, regulations, orders, judgments, injunctions and/or ordinances of any governmental authority.

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“Major EU Countries” means the United Kingdom, Spain, Italy, Germany and France. “Major Markets” means the United States and each of the Major EU Countries.

“Manufacturing and Supply Agreement” means the Manufacturing and Supply Agreement to be entered into by and between the Parties within ninety (90) days of the Effective Date, along with such related quality and technical agreements as may be referenced therein.

“Marketing Approval” means all Regulatory Approvals required from Regulatory Authority(ies) in a country other than Pricing and/or Reimbursement Approvals.

“Milestones” means the milestones relating to the Products as set forth in Section 7.2.

“Milestone Payments” means the payments to be made by Novartis to GW upon the achievement of the corresponding Milestones as set forth in Section 7.2.

“MS” means multiple sclerosis.

“Named Patient Sales” means the sale or other supply of a Product in a given country in the Territory prior to receipt of Marketing Approval of such Product in such country, directly or through an entity that is qualified to distribute unregistered pharmaceutical products in that country, on a “named-patient” basis to meet the special needs of particular patients under the order of a medical practitioner.

“Net Sales” means the net sales recorded by Novartis or any of its Affiliates or Sublicensees for any Product sold to Third Parties (other than Sublicensees) in bona fide, arms length transactions, as determined in accordance with Novartis’ Accounting Standards as consistently applied, less a deduction of *** for direct expenses related to the sales of the Product, distribution and warehousing expenses and uncollectible amounts on previously sold products. The deductions booked on an accrual basis by Novartis and its Affiliates under its Accounting Standards to calculate the recorded net sales from gross sales include the following:

(a) normal trade and cash discounts;

(b) amounts repaid or credited by reasons of defects, rejections, recalls or returns;

(c) rebates and chargebacks to customers and third parties (including, without limitation, Medicare, Medicaid, Managed Healthcare and similar types of rebates);

(d) any amounts included in gross sales for goods provided for free;

(e) amounts provided or credited to customers through coupons and other discount programs;

(f) delayed ship order credits, discounts or payments related to the impact of price increases between purchase and shipping dates;

(g) fee for service payments to customers for any non-separable services (including compensation for maintaining agreed inventory levels and providing information); and

(h) other reductions or specifically identifiable amounts deducted for reasons similar to those listed above in accordance with Novartis’ Accounting Standards.

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With respect to the calculation of Net Sales:

(i) Net Sales only include the value charged or invoiced on the arm’s length sale of Product to the first Third Party (other than a Sublicensee) in the distribution chain and sales between or among Novartis and its Affiliates and Sublicensees shall be disregarded for purposes of calculating Net Sales;

(ii) If a Product is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated at the time all the revenue recognition criteria under Novartis Accounting Standards are met for Product sold by Novartis or its Affiliates, and for Product sold by any Sublicensee, at the time all the revenue recognition criteria under such Sublicensee’s Accounting Standards are met;

(iii) In the event that the Product is sold in a final package containing a Product together with one or more other products (a “Co-Packaged Product” ), the Net Sales will be calculated by multiplying the Net Sales of the Co-Packaged Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in the relevant country of the Product when sold alone, and B is the weighted average sale price (by sales volume) in that country of the other product(s) included in the Co-Packaged Product. If the weighted average sale price cannot be determined for the Product or other product(s) included in the Co-Packaged Product, the calculation of Net Sales for such Co-Packaged Product will be agreed by the Parties based on the relative value contributed by each product included in the Co-Packaged Product (each Party’s agreement not to be unreasonably withheld or delayed).

(iv) In the event of any sale or other disposal for value, such as barter or counter-trade, of any Product other than in an arm’s length transaction exclusively for money, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Product in the country of sale or disposal.

To the extent that GW makes any Named Patient Sales in the Territory pursuant to Section 6.2(f), references in this definition to “Novartis” shall be deemed references to “GW.”

“Novartis Competitor” means, (i) for the purposes of Section 9.4, any Person which, at the time of the event in question (a) is a pharmaceutical or biopharmaceutical company with worldwide pharmaceutical or biopharmaceutical sales in excess $*** in the previous Calendar Year (based on data provided by IMS International, or if such data is not available, such other reliable data source as is determined by Novartis) or (b) commercializes in the Territory any product which contains CBD and/or THC (either alone or in combination with one or more other active ingredients); or (c) commercializes in the Territory any product approved for the one or more of the indications for which any Product is approved; and (ii) for the purposes of Section 3.4, any Person that meets the criteria set forth in (a), (b) or (c) above either at the time of Change of Control of GW or at any time thereafter.

“Novartis Marks” has the meaning given to it in Section 6.3(b).

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“Otsuka Patents” means the following patent applications and any and all Patent Rights claiming priority therefrom: ***, ***, *** and any other Patent Rights that are co-owned by GW and Otsuka Pharmaceutical Co. Ltd at any time after the Effective Date.

“PCT” means the Patent Cooperation Treaty done at Washington on 19th June 1970, as amended from time to time.

“Patent Rights” means all patents and patent ‘applications, including all divisionals, continuations, substitutions, continuations-in-part, re-examinations, reissues, additions, renewals, extensions, registrations, and supplemental protection certificates and the like of any of the foregoing.

“Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.

“Pricing and/or Reimbursement Approval” shall mean, in countries in the Territory where Regulatory Authorities may approve or determine pricing or pricing reimbursement for pharmaceutical products, such approval or determination.

“Product” means Sativex, together with any formulation improvement thereof, new indication therefor or modification thereto, and any Back-up Product.

“Regions” means the Asia Region, the Africa Region and the Middle East Region and “Region” means any of them.

“Regulatory Approvals” means, with respect to a Product, any approval (including Marketing Approvals and, where applicable, Pricing and/or Reimbursement Approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

“Regulatory Authority” means, with respect to any country, any governmental agency(ies) or authority(ies) responsible for the granting or receipt, as the case may be, of Regulatory Filings and/or Regulatory Approvals for a Product in that country.

“Regulatory Filings” means, with respect to the Products, any submission to a Regulatory Authority of any appropriate regulatory application, and shall include, without limitation, any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto. For the avoidance of doubt, Regulatory Filings shall include any IND, NDA or the corresponding application in any other country or group of countries.

“Resulting Intellectual Property” has the meaning given to it in Section 8.1(c).

“Sales & Royalty Report” means a written report or reports showing each of: (a) the Net Sales of each Product in each country in the Territory during the reporting period by Novartis and its Affiliates and Sublicensees; and (b) the royalties payable, in United States Dollars, which shall have accrued hereunder with respect to such Net Sales.

“Sativex” means the pharmaceutical product, developed by GW for therapeutic use, which is described on Exhibit B .

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“Senior Officers” means, for Novartis, the Global Head, Business Development and Licensing of Novartis Pharma AG, and for GW, the Managing Director.

“Subcontract” means an arrangement whereby Novartis or its applicable Affiliate engages a Third Party to provide particular services related to the registration or Commercialization of Products in one or more countries on the Territory, and “Subcontractor” has a corresponding meaning. For the avoidance of doubt, distribution, wholesaler, co-commercialization, exclusive promotion and/or field force services agreements shall all be deemed to be Subcontracts (and not Sublicenses) for purposes of this Agreement.

“Sublicense” means an arrangement whereby Novartis grants to a Third Party all of its rights hereunder with respect to one or more Products in one or more countries on the Territory, and “Sublicensee” has a corresponding meaning.

“Supply Failure” means any failure by GW to deliver at least *** percent (***%) of the aggregate amount of Novartis’ properly forecast and ordered (in accordance with the Manufacturing and Supply Agreement) requirements of any Product (excluding any deliveries of deviating or non-conforming Product) over the longer of (i) three (3) consecutive deliveries or (ii) four (4) months.

“THC” means tetrahydrocannabinol and tetrahydrocannabinolic acid.

“Term” means the term of this Agreement referred to in Section 10.1.

“Territory” means each of the countries listed on Exhibit C to this Agreement. The countries in Part A of Exhibit C are the Africa Region, the countries Part B of Exhibit C are the Asia Region and the countries in Part C of Exhibit C are the Middle East Region.

“Third Party” means any Person other than Novartis and GW and their respective Affiliates.

“United States” or “US” means the United States of America, its territories and possessions.

“USD” or “US$” means the lawful currency of the United States.

1.2 Interpretation. In this Agreement, unless otherwise specified:

(a) “includes” and “including” will mean respectively includes and including without limitation;

(b) a Party includes its permitted assignees and/or the respective successors in title to substantially the whole of its undertaking;

(c) a statute or statutory instrument or any of their provisions is to be construed as a reference to that statute or statutory instrument or such provision as the same may have been or may from time to time hereafter be amended or re-enacted;

(d) words denoting the singular will include the plural and vice versa and words denoting any gender will include all genders;

(e) the Exhibits and other attachments form part of the operative provisions of this Agreement and references to this Agreement will, unless the context otherwise requires, include references to the Exhibits and attachments;

(f) the headings in this Agreement are for information only and will not be considered in the interpretation of this Agreement;

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(g) general words will not be given a restrictive interpretation by reason of their being preceded or followed by words indicating a particular class of acts, matters or things; and

(h) the Parties agree that the terms and conditions of this Agreement are the result of negotiations between the Parties and that this Agreement will not be construed in favor of or against any Party by reason of the extent to which any Party participated in the preparation of this Agreement.

2. LICENSES AND OTHER GRANTS

2.1 Grants.

(a) Subject to the terms and conditions of this Agreement, GW hereby grants Novartis, an exclusive, royalty-bearing, sub-licensable license under the GW Technology to use, import, offer for sale, sell, have sold and otherwise Commercialize Products in the Field in the Territory.

(b) Subject to the terms and conditions of this Agreement, GW hereby grants Novartis, (i) a non-exclusive, sublicensable license under the GW Technology to make and have made anywhere in the world outside of the United States and the Almirall Territory, BDP (for sale as Product in the Field in the Territory) from BDS supplied by GW; provided , however , that such license shall be exercisable by or on behalf of Novartis only in the event of a Supply Failure; and (ii) a non-exclusive, non-sublicensable license under the GW Technology to make and have made (including the right to sub-contract) anywhere in the world outside of the United States and the Almirall Territory, BDP (for sale as Product in the Field in the Territory) from BRM or BDS supplied by GW, a Third Party or produced by Novartis; provided however , that such license shall be exercisable by Novartis only in the event of an Extreme Supply Failure. ***

(c) Following the Effective Date GW shall use commercially reasonable efforts to negotiate with Almirall and obtain an amendment to the Almirall Agreement pursuant to which GW may grant to Novartis a non-exclusive license to make and have made BDP (for sale as Product in the Field in the Territory) from BDS anywhere in the Almirall Territory exclusively for the purpose of commercializing such Product produced in the Territory. GW will keep the JSC reasonably informed of the progress of such negotiations. Once the Almirall Agreement has been amended as outlined above GW will so notify Novartis, whereupon the words “and the Almirall Territory” shall be deemed deleted from the third and forth lines of Section 2.1(b).

(d) GW hereby grants to Novartis an exclusive, sub-licensable license under the GW Trademarks for the purposes of Novartis’ Commercialization of Products in the Territory.

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(e) Novartis shall have the right to record the licenses granted under GW Patents and GW Trademarks pursuant to Sections 2.1 (a), (b) and (d) in any country within the Territory where such Patent Rights and trademarks have been registered, granted or applied for, at its own cost and expense, and GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing.

(f) Novartis hereby grants GW the following perpetual, irrevocable, fully paid-up, royalty free licenses under the Resulting Intellectual Property to GW:

(i) the exclusive right to Develop the Products anywhere in the world;

(ii) the exclusive right to use, import, offer for sale, sell, have sold and otherwise Commercialize the Products anywhere in the world outside of the Territory;

(iii) the non-exclusive right to manufacture BDS, BDP or Product anywhere in the world.

Such licenses shall be sub-licensable by GW only to those of its licensees for the Products who grant corresponding licenses to GW which are freely sub-licensable by GW and included within the licenses granted to Novartis under Section 2.1(a).

2.2 Sublicense and Subcontract Rights.

(a) Novartis may exercise its rights and perform its obligations under this Agreement itself or through any of its Affiliates.

(b) In addition, Novartis may Subcontract to Third Parties the performance of tasks and obligations with respect to the registration and Commercialization of Products in the Territory as Novartis deems appropriate.

(c) For all countries in the Territory other than Australia and South Korea, Novartis may sublicense the rights granted to it by GW under this Agreement to one or more Third Parties at any time at its sole discretion and without the consent of GW; provided , however , that Novartis shall provide GW with written notice in advance of granting any such Sublicense.

(d) In Australia and South Korea, Novartis may sublicense the rights granted to it by GW under this Agreement to one or more Third Parties at any time with the prior written consent of GW, such consent not to be unreasonably withheld or delayed, and provided always that Novartis shall not sublicense all or substantially all of its rights to the Products in the Field in the Territory to a single Third Party.

(e) Where either Party is entitled to sublicense the rights granted to it hereunder or subcontract its obligations hereunder, such Party as sublicensor/contractor shall remain responsible for all of its obligations hereunder and if the acts or omissions of any such sublicensee/ subcontractor cause said sublicensor/ contractor Party to be in breach of this Agreement that Party shall be responsible therefor regardless of any remedy which the sublicensor/ contractor Party may have against the sublicensee/ subcontractor for breach of the sublicense/ sub-contract.

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2.3 Exclusivity.

(a) During the Term of the Agreement, neither GW nor any of its Affiliates will, directly or indirectly, (i) license any of its rights in the Product to any Third Party for the Territory, nor (ii) assign or otherwise dispose of any of its rights in the Product to any Third Party for the Territory other than in accordance with Section 14.1, nor (iii) enter into any collaboration or license agreement with any Third Party in connection with the development of a Competitive Product for the Territory, nor (iv) market, sell or otherwise commercialize, itself or through any Third Party, any Competitive Product in the Territory.

(b) During the Term of the Agreement, neither Novartis nor any of its Affiliates engaged in the Commercialization of the Product will, directly or indirectly, market, sell or otherwise commercialize, itself or through any Third Party, any Competitive Product in the Territory.

(c) In addition, in the event that GW develops any other product, regardless of its composition, for the treatment of any indication for which Sativex has received Marketing Approval at the time GW initiates out-licensing for, or first files for approval for, such other product, Novartis will have the exclusive right to negotiate with GW to obtain rights to such product in the Territory, for a period of up to one hundred and twenty (120) days commencing upon the earlier of (i) notification from GW that it intends to out-license the commercial rights to said product for the Territory and has agreed a term sheet containing the financial terms for such an out-license with a Third Party licensee, and (ii) the first filing for approval of such product by or on behalf of GW anywhere in the world.

2.4 Territorial Restrictions. During the Term of the Agreement:

(a) GW covenants that (other than as permitted under Section 6.2(f) with respect to Named Patient Sales and under Section 6.2(g) with respect to international congresses and symposia) neither it nor any of its Affiliates or ex-Territory licensees will, directly or indirectly: (i) sell any Product within the Territory; , (ii) knowingly sell any Product for use within the Territory; (iii) sell any Product to a customer or patient located or resident in the Territory or which it knows intends to use such Product in the Territory; (iv) import, or cause to be imported, any Product into the Territory; or (v) market or promote any Products within, or to health care professionals, customers or patients located or resident in, the Territory.

(b) Novartis covenant that (other than as permitted under Section 6.2(g) with respect to international congresses and symposia) neither it nor any of its Affiliates or Sublicensees will, directly or indirectly: (i) sell any Product outside the Territory; (ii) knowingly sell any Product for use outside the Territory; (iii) sell any Product to a customer or patient located or resident outside the Territory or which it knows intends to use such Product outside the Territory; (iv) export, or cause to be exported any Product out of the Territory; or (v) market or promote any Product outside, or to health care professionals, customers or patients located or resident outside the Territory.

2.5 Right of Negotiation. GW hereby grants Novartis the right to negotiate with GW to import, offer for sale, sell, have sold, and otherwise Commercialize Products in the LATAM Region for the Exclusive Negotiation Period as follows:

(a) Neither GW nor any of its Affiliates shall enter into any agreement granting one or more Third Parties the right to import, offer for sale, sell, have sold, and/or otherwise Commercialize Products in the LATAM Region before or during the Exclusive Negotiation Period.

(b) Novartis shall notify GW within ninety (90) days’ of the Effective Date whether it is interested in negotiating with GW a right to import, offer for sale, sell, have sold, and otherwise Commercialize Products in the LATAM Region.

(c) Should Novartis notify GW within ninety (90) days’ of the Effective Date that it is not interested in negotiating with GW a right to import, offer for sale, sell, have sold, and otherwise Commercialize Products in the LATAM Region the Exclusive Negotiation Period shall terminate upon delivery of such notice.

(d) Should Novartis fail to give GW any notice pursuant to Section 2.5 within the abovementioned ninety (90) day period, the Exclusive Negotiation Period shall be deemed to have terminated upon the expiry of the abovementioned ninety (90) day period.

3. GOVERNANCE

3.1 Alliance Managers. Within thirty (30) days following the Effective Date, each Party will appoint (and notify the other Party of the identity of) a senior representative having a general understanding of pharmaceutical development and commercialization issues to act as its alliance manager under this Agreement ( “Alliance Manager” ). The Alliance Managers will serve as the contact point between the Parties for the purpose of providing GW with information on the progress of Novartis’ Commercialization of the Product(s) in the Field in the Territory and will be primarily responsible for facilitating the flow of information, including facilitating review of external corporate communications, and raising cross-Party and/or cross-functional disputes in a timely manner. Each Party may replace its Alliance Manager on written notice to the other Party.

3.2 Joint Steering Committee.

(a) The Parties will establish a Joint Steering Committee, composed of three (3) senior personnel of GW and three (3) senior personnel of Novartis (one (1) of which will be the Party’s Alliance Manager and which personnel for each Party, collectively, shall have a general understanding of drug manufacturing, development and Commercialization issues).

(b) Within thirty (30) days following the Effective Date, each Party will designate its initial members to serve on the JSC and notify the other Party of the dates of availability for the first meeting of the JSC. Each Party may replace its representatives on the JSC on written notice to the other Party.

(c) The JSC will serve as a forum for: (i) the Parties to review and discuss (A) Development activities with respect to the Products, including any planned or ongoing Development activities of GW, its Affiliates or other licensees outside the Territory and (B) manufacturing issues arising under the Manufacturing and Supply Agreement and more generally; (ii) GW to keep Novartis’ representatives informed of issues relating to manufacture and supply of Product; (iii) at least once per Calendar Year, Novartis to present to GW its Commercialization Plan for the following Calendar Year; and (iv) consider and act upon such other matters as specified in this Agreement. All matters presented at, or in preparation for, any meeting of the JSC shall be subject to the confidentiality restrictions set forth in Article 9.

(d) The JSC also may, at any time it deems necessary or appropriate, establish additional joint committees and delegate such of its responsibilities as it determines appropriate to such joint committees.

3.3 Meetings of the Joint Steering Committee.

(a) The JSC shall meet every six (6) months, and at such other times as the Parties may agree. The first meeting of the JSC shall be held as soon as reasonably practicable, but in no event later than ninety (90) days following designation of the members of the JSC under Section 3.2(b). Meetings shall be held at such place or places as are mutually agreed or by teleconference or videoconference; provided , however , that there shall be at least one face-to-face meeting per Calendar Year, unless the Parties otherwise agree.

(b) Each Party may from time to time invite a reasonable number of participants, in addition to its representatives, to attend JSC meetings, with the consent of the other Party (which shall not be unreasonably withheld); provided , that that if GW intends to have any Third Party (including any consultant) attend such a meeting, such Third Party will be subject to the prior approval of Novartis and must be bound by confidentiality obligations consistent with the terms of this Agreement.

(c) Novartis shall appoint one of its representatives on the JSC to act as chairperson of the JSC. The chairperson shall set agendas for JSC meetings, provided that the agendas will include any matter requested by either Party. The chairperson shall be responsible for recording, preparing and, within a reasonable time, issuing draft minutes of each JSC meeting, which draft minutes shall be subject to review and approval by all JSC members.

3.4 Change of Control. In the event of a Change of Control of GW pursuant to which control of GW is acquired by a Person who, either (i) at the time of the acquisition is a Novartis Competitor, or (ii) who subsequently becomes a Novartis Competitor, Novartis may (once such third Person acquirer meet the conditions for a Novartis Competitor) provide written notice to GW (or its successor entity) terminating the provisions of Article 3 and upon such notice, Novartis will not be obligated under Article 3 for the remainder of the Term. Without limiting the foregoing and notwithstanding any other provision of this Agreement, in the event that Novartis exercises such right to terminate the provisions of Article 3: (a) Novartis shall have no obligation to share Commercialization Plans with GW (or its successor entity), but by no later than 1st March each Calendar Year Novartis shall provide GW with (i) a written narrative report detailing, for the foregoing calendar year, (A) the Regulatory Filings made and the Regulatory Approvals obtained in the Territory, (B) the countries in which the Product was Launched, (C) a list of the countries in the Territory where a Competitive Product has been launched, (D) copies of the promotional, advertising and/or marketing materials provided by Novartis to Third Party health care professionals in the Territory in the previous calendar year (in English and in the local language where this is different to English and Novartis has used such local language versions); and (b) within thirty (30) days following the end of each Calendar Quarter, GW (or its successor entity) will provide a written report to Novartis detailing: (i) all Development activities with respect to the Products outside the Territory, including any planned or ongoing Development activities of GW, its Affiliates or other licensees outside the Territory, the conduct of which may be necessary or useful for obtaining or maintaining Regulatory Approvals for the Product (including obtaining or maintaining Regulatory Approvals for new indications) in the Territory; and (ii) any material issues which may affect GW’s ability to supply Novartis with its requirements for BDP or finished Product (as applicable) under the Manufacturing and Supply Agreement.

4. DEVELOPMENT AND PRODUCT INFORMATION

4.1 Disclosure of GW Know-How.

(a) Within thirty (30) days after the Effective Date, GW will disclose to Novartis or its designated Affiliate, without any additional consideration, all Know-How owned or

Controlled by GW or its Affiliates as of the Effective Date which is reasonably necessary for the registration or Commercialization of Sativex in the Field in the Territory.

(b) Thereafter on a regular basis (but no more frequently than once each Calendar Quarter) during the Term, GW, without additional consideration, shall disclose to Novartis or its designated Affiliate all material additional Know-How owned or Controlled by GW or its Affiliates which comes in to existence from time to time which is reasonably necessary for the registration or Commercialization of any Product in the Field in the Territory.

(c) The disclosures described in (a) and (b) above shall include all documented Know-How owned or Controlled by GW or its Affiliates which may be necessary to Novartis to register or Commercialize Products in the Field in the Territory and practice the licenses granted hereunder efficiently, including the following to the extent necessary for the above purposes: (i) all such Know-How pertaining to the formulation, manufacture and Development of the Products; (ii) all Development data and any other data, including but not limited to chemical, biological, toxicological safety, pre-clinical and clinical data; and (iii) all Development reports, analytical results, filings and correspondence with any Regulatory Authority (including notes or minutes of any meetings with any Regulatory Authority) to the extent owned or Controlled by GW or its Affiliates, raw material and excipient sourcing information, quality audit findings and any other relevant technical information relating to any Product.

4.2 Clinical Studies and Data Sharing.

(a) ***

(b) GW shall share with Novartis all clinical and other data generated in the course of any such Development activities as provided in Section 4.1; provided , however , that:

(i) GW’s obligation to share clinical data applies only with respect to data generated for the purposes of obtaining Regulatory Approval of Products in any Major Market and any clinical data, including ethnic variation data, for the cancer pain indication, generated for the purposes of obtaining Regulatory Approval of Products for cancer pain in any Major Market which is required by Novartis to enable Novartis to obtain Regulatory Approval for the Product in any country in the Territory; and

(ii) in the event that GW generates clinical data sufficient to enable a Regulatory Filing for any Product in countries in the Territory for indications other than the treatment of spasticity in MS or the treatment of cancer pain, GW shall make such data available to Novartis on commercial terms (that is, milestone payment(s)) to be agreed between the Parties at that time.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(c) As part of its Commercialization activities, Novartis will be responsible, at its own cost and expense, for carrying out any Phase IV clinical studies of any Product conducted for purposes other than obtaining or maintaining any Marketing Approval it determines appropriate in its sole discretion. For clarity, GW shall be responsible for carrying out any Phase IV clinical studies required for purposes of obtaining Marketing Approval and for carrying out any Phase IV clinical studies required to maintain a Marketing Approval; provided , however , that:

(i) if such Phase IV clinical study has been proposed by Novartis or its Affiliates, GW shall only be responsible for carrying out such Phase IV clinical study if Novartis (or its Affiliate) has first consulted with GW with respect to such proposal and GW has expressly consented to perform such Phase IV clinical study; and

(ii) other than as set forth in paragraph (i) above, GW shall only be responsible for carrying out such Phase IV clinical study if Novartis (or its Affiliate) has discussed the same with GW and GW has expressly consented to perform such Phase IV clinical study (such consent not to be unreasonably withheld or delayed). If GW does not consent to carrying out such Phase IV clinical study the provisions of Sections 6.2 and 6.4 shall cease to apply to the country in question.

Novartis will make available to GW, without additional consideration, all clinical data generated by Novartis as part of any Phase IV clinical study conducted by it under this Section 4.2(c); provided , however , that GW shall have no right to provide access to such data to a licensee outside the Territory unless such licensee provides corresponding access rights to Novartis.

5. SUPPLY OF PRODUCT TO NOVARTIS

5.1 Manufacturing and Supply. GW shall be solely responsible, at its own cost for the manufacture and supply of Novartis’ requirements of finished Product, or BDP for use in the packaging and labeling of finished Product, for Commercialization in the Field in the Territory, as set forth in the Manufacturing and Supply Agreement. For clarity, as provided for in Exhibit F , the supply of finished Product is an additional service which may be provided if (i) requested by Novartis, and (ii) the Parties agree upon the fees for this service.

5.2 Manufacturing and Supply Agreement. The Parties shall enter into a manufacturing and supply agreement relating to the supply of Sativex in the form of BDP and/or finished Product and any necessary quality agreement(s) within ninety (90) days of the Effective Date. This manufacturing and supply agreement shall, inter alia reflect the principles set forth in Exhibit F .

6. REGULATORY AFFAIRS AND COMMERCIALIZATION

6.1 Regulatory Affairs. From the point in time at which Novartis gives GW notice in writing that it wishes to take on responsibility for Regulatory Filings and Regulatory Approvals in the Territory, Novartis shall be responsible for all interactions with Regulatory Authorities in the Territory with respect to Regulatory Approvals as set forth in this Section 6.1, and including, filing and maintaining any required Regulatory Approvals, seeking necessary permits and/or scheduling or re-scheduling in

controlled substance listings or de-scheduling of the Product from controlled substances listings in the Territory.

(a) Where required, Novartis (or its applicable Affiliate or Sublicensee) will be responsible for arranging for the Product to be scheduled in any applicable controlled substance schedule(s) in countries in the Territory. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing and to provide Novartis with all assistance reasonably requested by Novartis (including attending meetings with Regulatory Authorities in any such country) for the purpose of arranging for such scheduling.

(b) Subject to Section 6.1(g), Novartis (or its applicable Affiliate or Sublicensee) will file and hold all Regulatory Approvals for the Products in countries in the Territory in its own name and on its own behalf. Unless otherwise agreed by the Parties, within ten (10) Business Days following the Effective Date, GW will assign to Novartis all Regulatory Filings with any Regulatory Authority in the Territory at the Effective Date relating to any Product and Novartis will reimburse GW all fees paid by GW to Regulatory Authorities in such countries with respect to the submission of such Regulatory Filings. On request by Novartis, GW will deliver notices of such assignment to the applicable Regulatory Authorities. In addition, GW agrees to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing.

(c) Subject to Sections 4.2 and 6.1(e), Novartis (or its applicable Affiliate or Sublicensee) will be responsible for conducting, at its sole expense, such activities directed towards obtaining and maintaining Regulatory Approvals for Products in the Territory as it determines appropriate in its sole discretion; provided , however , that Novartis agrees to submit Regulatory Filings for Marketing Approvals for a Product in each of the Key Countries. Thereafter, Novartis shall, on a Key Country-by-Key Country basis further prosecute all such Regulatory Filings in the Key Countries in a timely, professional and diligent manner, including by paying all required filing fees promptly and responding to correspondence and requests for further information from Regulatory Authorities in the Key Countries within a reasonable timeframe. Novartis shall share with GW its plans for obtaining Regulatory Approvals in the Key Countries at the first JSC meeting and thereafter shall supply GW with its updated plan from time to time. Novartis shall report its performance against this regulatory plan to the JSC each Calendar Quarter.

(d) Novartis will: (A) determine the regulatory plans and strategies for the Products in the Territory; (B) (either itself or through its Affiliates or Sublicensees and subject to Section 6.1(g)) make and own all Regulatory Filings with respect to the Products in the Territory; and (C) will be responsible for obtaining and maintaining Regulatory Approvals with respect to the Products in the Territory in the name of Novartis or its Affiliates or Sublicensees. Accordingly:

(i) Novartis, shall at its own cost write, assemble, otherwise prepare and file all Regulatory Filings required to obtain Regulatory Approvals for Products in the Territory;

(ii) Novartis shall be the principal contact with all Regulatory Authorities on all matters pertaining to any Product, but shall consult regularly with GW regarding such matters, giving due regard to GW’s views;

(iii) Novartis shall provide to GW copies of all substantive correspondence with Regulatory Authorities in the Territory related to any Product, and, to the extent

practicable, shall consult with GW in advance of submitting any material correspondence related to any Product to any such Regulatory Authority;

(iv) GW shall provide to Novartis copies of all substantive correspondence with the EMA related to any Product and, to the extent practicable, shall consult with Novartis in advance of submitting any material correspondence related to any Product to the EMA in circumstances where such correspondence could reasonably be expected to impact on the Commercialization and/or Regulatory Approvals of any Product in the Territory;

(v) Novartis shall provide such notice to GW as is reasonably practicable under the circumstances of upcoming meetings related to any Product with Regulatory Authorities in the Territory. Subject to the consent of the relevant Regulatory Authority, GW shall be entitled to attend any such meetings as an observer, and Novartis may require GW’s attendance at any such meeting it deems to be potentially material; and

(vi) Novartis shall pay all filing and maintenance costs of Regulatory Filings and Regulatory Approvals for the Product in the Territory during the Term.

(e) GW shall, without additional consideration, fully cooperate with and provide assistance to Novartis in connection with filings to any Regulatory Authority relating to the Product(s) in the Territory in order to obtain or maintain Regulatory Approvals (including Pricing and/or Reimbursement Approvals, where applicable), including by (i) providing Novartis with an electronic copy of the registration dossier for the Product in the European Union as well as providing Novartis with an electronic copy of this registration dossier in eCTD format if and when available in eCTD format, and upon request by Novartis, an electronic copy of a draft of the registration dossier for the Product in the US as soon as such draft is made available to GW (if this draft is made available to GW in eCTD format GW will provide it to Novartis in eCID format); (ii) upon request by Novartis, providing Novartis with draft responses to any requests from Regulatory Authorities in the Territory related to the Development or manufacture of Products (including any requests related to the chemistry manufacturing and controls (CMC) section of any Regulatory Filing); and (iii) executing any required documents, providing access to personnel and providing Novartis with copies of all reasonably required documentation. To the extent requested by Novartis, GW shall also grant or cause to be granted to Novartis and its Affiliates or Sublicensees, within thirty (30) days of receipt of a written request from Novartis, cross-reference rights to any relevant drug master files and other filings submitted by GW or its Affiliates with any Regulatory Authority and any Regulatory Approval for Product issued by any Regulatory Authority to GW or its Affiliates.

(f) Subject to Novartis having access to reimbursement data from outside the Territory, data generated by Novartis for reimbursement shall be available for GW and its ex-Territory licensees of the Products to use with respect to the Products outside the Territory.

(g) In the event that (A) it is not possible under applicable Laws for Novartis to file for or hold Regulatory Approvals for the Product in any country in the Territory and/or (B) if requested by Novartis in writing to do so, to the extent permitted by applicable Laws and for the duration determined by Novartis, GW will file and/or hold all Regulatory Approvals for the Products in such country, at Novartis’s cost and expense ( provided that all such costs and expenses shall be in accordance with a plan and budget agreed in writing by the Parties prior to GW making any such Regulatory Filing), and:

(i) GW will be responsible for, and will use diligent efforts in, obtaining and maintaining all Regulatory Approvals necessary for the Commercialization of the Products in the country in question;

(ii) GW will provide to Novartis copies of all substantive written communications between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product;

(iii) Novartis shall have the right to review and comment upon any Regulatory Filings and correspondence from GW (or its Affiliates) to any Regulatory Authority in the Territory relating to any Product, and GW shall incorporate or address all such comments unless otherwise agreed between the Parties;

(iv) GW will request and seek to arrange such meetings and consultations with Regulatory Authorities in the Territory which may be requested by Novartis, with respect to any Product;

(v) To the extent permitted by the relevant Regulatory Authorities, Novartis shall have the right to have representatives of Novartis attend and participate in all meetings between GW (or its Affiliates) and any Regulatory Authority in the Territory relating to any Product; it being understood and agreed that to the extent permitted by the relevant Regulatory Authorities, Novartis will lead discussions with any such Regulatory Authority in the Territory. If the applicable Regulatory Authority does not permit Novartis to lead any such discussion, GW will lead the applicable discussions as directed by Novartis; and

(vi) Novartis will reimburse GW any and all costs incurred pursuant to the foregoing and in accordance with the agreed plan and budget as follows. Within thirty (30) days after each Calendar Quarter during which GW has incurred any such costs and expenses, GW will provide to Novartis a detailed accounting of all such costs and expenses, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such costs and expenses. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice.

(h) Novartis hereby grants, and undertakes to cause its Affiliates and Sublicensees to grant, to GW and its Affiliates cross-reference rights to any Regulatory Filing for Product submitted by Novartis or its Affiliates or Sublicensees to any Regulatory Authority in the Territory and any Marketing Approval for Product issued by any Regulatory Authority in the Territory to Novartis or its Affiliates or Sublicensees. Novartis shall also grant such cross-reference rights to those of GW’s licensees of the Products for countries outside the Territory for which Novartis, its Affiliates and Sublicensees are granted corresponding cross-reference rights.

(i) The Parties will discuss at the JSC the appropriate response to any request received by either Party from a Third Party academic institution to conduct any investigator initiated clinical study of a Product in the Territory.

(j) If any information comes into GW’s Control that requires a change to the CMC section of Regulatory Filings or Regulatory Approvals, inside and outside the Territory, to avoid ‘regulatory drift’ GW will inform Novartis in writing of the required change (including by providing the necessary technical documentation in English) and Novartis will file such documentation with the relevant Regulatory Authorities as soon as practicable.

6.2 Commercialization.

(a) Novartis will be solely responsible for all aspects of Commercialization of the Product in the Territory, including planning and implementation, distribution, booking of sales, pricing, reimbursement, regulatory, manufacturing (limited to packaging and trade dress), phase IV studies, marketing and sales activities.

(b) All such Commercialization activities will be conducted in accordance with Novartis’ then-current Commercialization Plan.

(c) Novartis shall itself, or through its Affiliates or Sublicensees, use Commercially Reasonable Efforts in pursuing the Commercialization of the Products in the Territory. Notwithstanding the foregoing, subject to Section 6.4, Novartis’ application of Commercially Reasonable Efforts shall not require Novartis to Commercialize a Product in any country in which Novartis (acting reasonably) determines it is not commercially reasonable to do so for such Product. Should Novartis determine that it is not commercially reasonable to Commercialize the Product in a particular country in the Territory, Novartis shall promptly notify GW of such determination and the basis on which Novartis has made that determination.

(d) Novartis shall not Commercialize a Product in the Territory in conjunction or otherwise together with, any other product(s) as a loss leader without GW’s prior written approval, which approval may be withheld by GW for any reason. Novartis shall not offer for sale or sell in any country in the Territory a Product at a greater discount to list price than the usual or customary discounts it applies to other pharmaceutical products it offers for sale or sells in that country. Novartis shall not sell a Product as one of a number of items without a separate price i.e. Novartis will not sell a Product as part of a bundled transaction.

(e) Subject to compliance with Sections 6.2(b), (c) and (d), the Commercialization of the Products in the Territory shall be in Novartis’ sole discretion.

(f) Notwithstanding the exclusive licenses granted to Novartis under Section 2.1, or the remaining provisions of this Section 6.2, prior to the receipt of the first Marketing Approval for a given Product in a given country in the Territory, GW shall have the right to make Named Patient Sales in such country; provided , however , that within sixty (60) days after each Calendar Quarter in which GW has made any Named Patient Sales in the Territory, GW will provide to Novartis a written report showing the Net Sales of each Product in each country in the Territory during the reporting period by GW, which report shall be accompanied by payment to Novartis of an amount equal to fifty percent (50%) of such Net Sales.

(g) Notwithstanding: (I) the territorial restrictions on the licenses granted to Novartis under Section 2.1; or (II) the exclusive rights granted to Novartis in the Territory under this Agreement, the Parties agree that:

(i) Novartis, its Affiliates and Sublicensees may attend and participate in international congresses or symposia outside the Territory with respect to the Products; and

(ii) GW, its Affiliates and licensees may attend and participate in international congresses or symposia in the Territory with respect to the Products.

6.3 Trademarks.

(a) Novartis shall Commercialize the Products in the Territory using the GW Trademarks. Should the Regulatory Authorities in a country in the Territory object to the GW Trademark set out in Exhibit A at the Effective Date, or should the Parties otherwise agree that the GW Trademark on Exhibit A is not appropriate for a particular country GW will provide an alternative trademark for the Products in the country of the Territory in question as soon as reasonably practicable thereafter, but following approval of the alternative trademark by Novartis (and the filing of applications therefor). Each such alternative trademark provided by GW shall be the property of, filed in the name of and prosecuted and maintained by GW and shall be a GW Trademark for the purposes of this Agreement.

(b) Novartis shall also have the right to Commercialize the Products using such other Novartis corporate names, marks and logos as it determines appropriate for the Products, which may vary by country or within a country (“Novartis Marks”). Novartis shall own all rights in and to the Novartis Marks.

(c) Novartis shall ensure that each reference to and use of a GW Trademark by Novartis, its Affiliates and Sublicensees in any marketing material related to a Product in the Territory is accompanied by an acknowledgement that the GW Trademark is a trademark or registered trademark owned by GW and is used under license.

(d) Novartis shall provide GW with information and examples as to Novartis’, its Affiliates’ and Sublicensees’ use of the GW Trademarks, as GW may reasonably request, to permit GW’s proper maintenance and registrations of each GW Trademark.

(e) Novartis shall not (and shall ensure that its Affiliates and Sublicensees do not) do or perform any act that may endanger, destroy, or similarly affect the value of the goodwill pertaining to a GW Trademark nor do any act that might support a petition to cancel or otherwise invalidate any registration relating to a GW Trademark nor assist any other Person or other entity, directly or indirectly, in so doing.

(f) Novartis shall have the right to register and use, in its own name and at its own cost and expense, any domain name which corresponds to or include any GW Trademark for the purposes of Novartis’ Commercialization of Products in the Territory.

6.4 Return of Rights.

(a) In the event that, absent a determination by Novartis that is not commercially reasonable to do so and receipt of a notification to this effect pursuant to Section 6.2(c), Novartis decides permanently to not to seek Regulatory Approval for Products in a country in the Territory outside of the Key Countries or to not Commercialize Products (or not to continue to Commercialize Products) in any country in the Territory outside of the Key Countries, it will provide GW with written notice of such decision and the provisions of Section 6.4(d) shall apply with respect to that country.

(b) In the event that, with respect to any Key Country, Novartis has not:

(i) Submitted a Regulatory Filing for Marketing Approval of at least one Product in such Key Country within three (3) years of the Effective Date;

(ii) Submitted a Regulatory Filing for any applicable Pricing and/or Reimbursement Approval of a Product in such Key Country within three (3) months of receipt of Marketing Approval for the first Product in such Key Country;

(iii) Launched a Product in such Key Country within three (3) months of receipt of all Regulatory Approvals for the first Product in such Key Country,

then, unless Novartis has reasonably determined that is not commercially reasonable to do so and provided notice to GW of such determination and its reasons therefor pursuant to Section 6.2(c), Novartis shall be deemed to have decided permanently not to seek Regulatory Approval for Products in such Key Country or to not Commercialize Products (or not to continue to Commercialize Products) in such Key Country, and the provisions of Section 6.4(d) shall apply with respect to that Key Country.

(i) Submitted a Regulatory Filing for Marketing Approval of at least one Product in at least one non-Key Country in that Region within three (3) years of the date on which it submitted a Regulatory Filing for Marketing Approval of at least one Product in at least one Key Country in that Region; or

(ii) Submitted a Regulatory Filing for Marketing Approval of at least one Product in at least one country in that Region within six (6) years of the Effective Date,

Novartis shall be deemed to have decided permanently not to seek Regulatory Approval for Products in such Region, and the provisions of Section 6.4(d) shall apply with respect to the countries in such Region other than the Key Country(ies) in such Region where Novartis has submitted a Regulatory Filing for Marketing Approval of at least one Product within three (3) years of the Effective Date, for which country(ies) Novartis’ rights to the Products shall continue, subject to the provisions of Sections 6.4(b)(ii) and (iii).

(d) In the event that Novartis issues a notice under Section 6.4(a) or Novartis is deemed to have decided permanently to not to seek Regulatory Approval for Products in a country or Region or to not Commercialize Products (or not to continue to Commercialize Products) in a country under Section 6.4(b), GW may, and by giving Novartis notice in writing, elect that the provision of Section 11.2 apply with respect to the applicable country in the Territory the subject of a notice under Section 6.4(a) or for the country/Region for which Novartis is deemed to have decided permanently to not to seek Regulatory Approval for Products or to not Commercialize Products (or not to continue to Commercialize Products) under Section 6.4(b).

6.5 Pharmacovigilance.

(a) GW shall be responsible for maintaining the global safety database for each Product and for monitoring the overall safety of the Product, including signal detection.

(b) Novartis shall be responsible for pharmacovigilance activities with respect to Products in the Territory, including collecting and processing safety data and reporting to the Regulatory Authorities as required under applicable Laws.

(c) Within six (6) months following the Effective Date (or such longer period as may be agreed between the Parties), the Parties shall agree upon and implement a procedure for the mutual exchange, receipt, record, communication and investigation of adverse event reports and

safety or other information associated with the Products covered by this Section 6.5. Details of the operating procedure respecting such adverse event reports and safety information exchange shall be the subject of a mutually-agreed written pharmacovigilance agreement (“Pharmacovigilance Agreement”) between the Parties which shall be entered into within such six (6) month period (or such longer period as may be agreed between the Parties).

(d) Each Party agrees that the other may audit its pharmacovigilance systems/operations or contracted pharmacovigilance activities at reasonable intervals to ensure that the elements set forth in the Pharmacovigilance Agreement are being met. The Parties will discuss and agree in good faith on how such audits will be conducted (including with respect to audit plan, duration of audit, audit report and corrective actions). Each Party’s routine audit will be scheduled no more frequently than once every two (2) years, with a minimum of 90 days notice. All such audits shall be reasonable in scope, limited to the Product, and shall take place during normal business hours. The audited Party will correct (and/or ensure if Affiliates and Sublicensees correct) any audit observations in a timely manner and communicate its corrective actions to the other Party.

(e) Notwithstanding paragraph (d) above, in the case of a serious suspected breach of compliance with the Pharmacovigilance Agreement, a directed audit may be performed by either Party, or an independent Third Party, upon thirty (30) days written notice to the auditee, without further need for agreement between the Parties.

(f) The Parties shall allow foreign and local Regulatory Authorities in the Territory to inspect their pharmacovigilance operations as it is necessary for Novartis to obtain and maintain Regulatory Approvals for the Products in countries in the Territory. Each Party shall provide the other with written notice (at the time of the notification) of any inspection addressing Product-specific pharmacovigilance and allow a representative from the other Party to attend and participate in such inspections. The inspected Party shall communicate urgent or critical issues affecting the other Party’s pharmacovigilance activities within fourteen (14) Business Days of receipt of documented findings cited during a Regulatory Authority inspection. Once corrective actions are determined, the inspected Party will provide a summary of the relevant inspection findings, with associated corrective actions, where the other Party is impacted.

7. FINANCIAL PROVISIONS

7.1 Signature and Technical Access Fee. In consideration of the licenses and rights granted to Novartis hereunder, Novartis shall pay to GW a one-time, non-refundable, non-creditable upfront payment of five million USD (US$ 5,000,000) within thirty (30) days after receipt by Novartis of an invoice in the form of Exhibit E, which invoice shall be issued no earlier than the Effective Date.

7.2 Milestone Payments.

(a) In further consideration of the licenses and rights granted to Novartis hereunder, upon first achievement of each of the Milestones set forth below by Novartis, its Affiliates or sublicensees, the corresponding one-time Milestone Payments shall be payable by Novartis to GW:

Milestone	Milestone Payment (USD)

Regulatory/Reimbursement Milestones
Subject to the terms of Section 7.2(c): Upon the grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in Australia, for use of such Product for the treatment of spasticity in MS, where the reimbursed price for such Product is higher than US$***per vial	$	*** million

OR	OR

Upon the grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in Australia, for use of such Product for the treatment of spasticity in MS, where the reimbursed price for such Product is between US$* per vial and US$* per vial	$	*** million

OR	OR

Upon the grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in Australia, for use of such Product for the treatment of spasticity in MS, where the reimbursed price for such Product is lower than US$*** per vial	$	*** million
Upon the earlier of: (i) grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in * for use of such Product for the treatment of spasticity in MS, and (ii) Launch of the first Product in *	$	*** million
Upon the earlier of: (i) grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in both * for use of such Product for the treatment of spasticity in MS, and (ii) Launch of the first Product in *	$	*** million
Upon the grant of Marketing Approval for the first Product for the treatment of cancer pain by the applicable Regulatory Authorities in the ***	$	*** million
Upon the earlier of: (i) the grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in * for use of such Product for the treatment of cancer pain, and (ii) Launch of the first Product approved for *	$	*** million

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Milestone	Milestone Payment (USD)
Upon the earlier of: (i) the grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in * for use of such Product for the treatment of cancer pain, and (ii) Launch of the first Product approved for *	$	*** million
Upon the earlier of: (i) the grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in *for use of such Product for the treatment of cancer pain, and (ii) Launch of the first Product approved for *	$	*** million
Upon the earlier of: (i) grant of both (a) Marketing Approval and (b) Pricing and/or Reimbursement Approval for the first Product by the applicable Regulatory Authorities in * for use of such Product for an indication other than the treatment of spasticity in MS and the treatment of cancer pain; and (ii) Launch of the first Product in * for an indication other than the treatment of spasticity in MS and the treatment of cancer pain	$	*** million
Commercialization Milestones
First Calendar Year in which annual aggregate Net Sales in the Territory of all Products by Novartis, its Affiliates and Sublicensees exceed * million USD (US$ * million)	$	*** million
First Calendar Year in which annual aggregate Net Sales in the Territory of all Products by Novartis, its Affiliates and Sublicensees exceed * million USD (US$ * million)	$	*** million
First Calendar Year in which annual aggregate Net Sales in the Territory of all Products by Novartis, its Affiliates and Sublicensees exceed * million USD (US$ * million)	$	*** million
First Calendar Year in which annual aggregate Net Sales in the Territory of all Products by Novartis, its Affiliates and Sublicensees exceed * USD (US$ * million)	$	*** million

(b) Each Milestone Payment shall be deemed earned as of the first achievement of the corresponding Milestone by any of the Products and shall be notified by Novartis to GW within sixty (60) days after achievement of the Milestone. For the avoidance of doubt: (i) each Milestone Payment shall be payable only on the first occurrence of the Milestone; (ii) none of the Milestone Payments shall be payable more than once; and (iii) other than as set forth in Section 4.2(b)(ii), no additional Milestone Payments shall be due for Milestones completed for the Development and Commercialization of additional Products or of Products for any additional indications.

(c) If the first Product is Launched in Australia prior to obtaining Pricing and/or Reimbursement Approval, Novartis shall report the occurrence of such Milestone within sixty (60) days of

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achievement, at which point GW may invoice Novartis for *** USD (US$ ***), with the balance of the applicable Milestone Payment (if any) becoming due once Pricing and/or Reimbursement Approval is obtained and the approved reimbursement price is notified to GW.

7.3 Royalty Payments.

(a) In consideration of the licenses and rights to Novartis hereunder, during the applicable Royalty Term, Novartis will make royalty payments to GW, based on Net Sales of all Products in the Territory by Novartis, its Affiliates and sublicensees, at the applicable rates set forth below.

Aggregate Net Sales of Applicable Product throughout the Territory in any Calendar Year by Novartis, its Affiliates or Sublicensees	Royalty Rate
Portion of annual Net Sales of the Products which are less than or equal to US$ *** million	***	%
Portion of annual Net Sales of the Products which are over US$ * million but less than or equal to US$ * million	***	%
Portion of annual Net Sales of the Products which are over US$ * million but less than or equal to US$ * million	***	%
Portion of annual Net Sales of the Products which are over US$ *** million	***	%

(b) For example, if Net Sales of the Products in a Calendar Year are US$ *** million, the royalty on such Net Sales shall be equal to US$ *** million, that is, the sum of ***% of US$ *** million, ***.

(c) Royalties will be payable on a country-by-country basis from First Commercial Sale of the first Product in such country by Novartis, its Affiliates or Sublicensees for the Term of the Agreement, subject to adjustment for Third Party License Fees and Competitive Products as described in Sections 7.4 and 7.5 below.

(d) For the avoidance of doubt, royalties shall be payable only once with respect to the same unit of Product.

7.4 Third Party License Fees.

(a) GW shall remain responsible for the payment of royalty, milestone and other payment obligations, if any, due to Third Parties under any GW Technology which has been licensed to GW and is sublicensed to Novartis under this Agreement. All such payments shall be made promptly by GW in accordance with the terms of the applicable license agreement(s). In addition, in the event the Parties agree that rights to any Patent Rights issuing in the Territory from patent application *** are required to use, import, sell or otherwise Commercialize the Product in any country in the Territory, GW shall negotiate and acquire such rights through a license or otherwise at its own cost and expense, and such rights shall thereafter be deemed part of the GW Technology licensed to Novartis hereunder.

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(b) Subject to the provisions of Sections 7.4(a) and 13.1(d), in the event that either Party determines that rights to intellectual property owned or Controlled by a Third Party are required to research, develop, manufacture, use, import, sell or otherwise Commercialize a Product in any country in the Territory (in addition to the GW Technology and outside the intellectual property falling under the scope of sub-Section 7.4(a)) (such Third Party intellectual property being “Relevant Third Party Rights” ), it shall bring to the attention of the other Party such Relevant Third Party Patent Rights, and subject to the execution of a community of interest or joint defence agreement, provide to the other Party written notice of the basis of the determination that such a license is required and any available evidence related to such determination. GW shall have the right to determine whether any license to any such Relevant Third Party Rights is required; provided , however , that in the event that GW determines that no such license is required with respect to any given Relevant Third Party Right(s), the indemnity set forth in Section 13.1(e) shall apply with respect to such Relevant Third Party Right(s). GW shall also have the right to negotiate and acquire access to such Relevant Third Party Rights through a license or otherwise (but in each case such that the Relevant Third Party Rights are Controlled by GW and included in the licenses granted to Novartis under Section 2.1) and to add to the payments due to GW hereunder *** percent (***%) of the amounts paid (including milestone payments, royalties or other license fees) by GW to such Third Party attributable to Net Sales in countries in the Territory. Novartis agrees to fully cooperate with GW to acquire such rights. In the event that GW fails to acquire access to any Relevant Third Party Right(s) through a license or otherwise, the indemnity set forth in Section 13.1(e) shall apply with respect to such Relevant Third Party Right(s). For clarity, the Otsuka Patents are Relevant Third Party Patents.

7.5 Competitive Products. In the event one or more Competitive Product(s) are marketed by any Third Party(ies) in any country in the Territory, the royalty rates applicable to the Product in such country for the remainder of the Term shall be reduced as set forth below:

(a) For any period in which actual sales of Products in such country are between *** percent (***%) and *** percent (***%) of the Baseline Sales for such country, the royalty rate applicable to such country shall be equal to *** percent (***%) of weighted average royalty rate described in Section 7.3 on Net Sales throughout the Territory;

(b) For any period in which actual sales of Products in such country are between *** percent (***%) and *** percent (***%) of the Baseline Sales for such country, the royalty rate applicable to such country shall be equal to fifty percent (50%) of weighted average royalty rate described in Section 7.3 on Net Sales throughout the Territory;

(c) For any period in which actual sales of Products in such country are between *** percent (***%) and *** percent (***%) of the Baseline Sales for such country, the royalty rate applicable to such country shall be equal to *** percent (***%) of weighted average royalty rate described in Section 7.3 on Net Sales throughout the Territory; and

(d) For any period in which actual sales of Products in such country are less than *** percent (***%) of the Baseline Sales for such country:

(i) Novartis shall pay GW a royalty equal to the greater of: (A) *** percent (***%) of Net Sales of Products by Novartis, its Affiliates or Sublicensees in such country; and (B) [X] percent ([X]%) of Net Sales of Products by Novartis, its Affiliates or

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Sublicensees in such country, where [X] is such that the sum of [X] percent ([X]%) of such Net Sales and ***; and

(ii) sales of Products in such country shall not count towards aggregate Net Sales of the Product in the Territory for purposes of the royalty tiers set forth in Section 7.3(a).

For each Calendar Year, the anticipated royalty reductions applicable under this Section 7.5 for any given country will be determined based on Novartis’ forecast sales for such country, subject to annual reconciliation to actual sales in such country within sixty (60) days after the end of such Calendar Year. For clarity, the provisions of Section 7.11(g) shall apply in the event that any such reconciliation reveals an overpayment or underpayment of royalties by Novartis.

7.6 No Projections. GW and Novartis acknowledge and agree that nothing in this Agreement shall be construed as representing an estimate or projection of anticipated sales of any Product, and that the Milestones and Net Sales levels set forth above or elsewhere in this Agreement or that have otherwise been discussed by the Parties are merely intended to define the Milestone Payments and royalty obligations to GW in the event such Milestones or Net Sales levels are achieved. NEITHER GW NOR NOVARTIS MAKES ANY REPRESENTATION OR WARRANTY, EITHER EXPRESS OR IMPLIED, THAT GW, ITS AFFILIATES OR SUBLICENSEES WILL BE ABLE TO SUCCESSFULLY DEVELOP ANY PRODUCT OR, IF DEVELOPED, THAT NOVARTIS, ITS AFFILIATES OR SUBLICENSEES WILL BE ABLE TO SUCCESSFULLY COMMERCIALIZE ANY PRODUCT OR, IF COMMERCIALIZED, THAT ANY PARTICULAR NET SALES LEVEL OF SUCH PRODUCT WILL BE ACHIEVED.

7.7 Payment Terms.

(a) After receipt by GW of a notice given under Section 7.2(b), GW shall submit an invoice to Novartis substantially in the form of Exhibit E for the corresponding Milestone Payment, provided that no such invoice shall be submitted prior to the Effective Date. Novartis shall make the corresponding Milestone Payment within *** days after receipt of such invoice.

(b) Within *** days after each Calendar Quarter during the term of this Agreement following the First Commercial Sale of a Product in the Territory by Novartis, its Affiliates or Sublicensees, Novartis will provide to GW a Sales & Royalty Report. After receipt of such report, GW shall submit an invoice to Novartis substantially in the form of Exhibit E with respect to the royalty amount shown therein. Novartis shall pay such royalty amount within thirty (30) days after receipt of such invoice.

(c) All payments from Novartis to GW under this Agreement shall be made by wire transfer in US Dollars from a source in Switzerland to the credit of such bank account as may be designated by GW in this Agreement or in writing to Novartis. Any payment which falls due on a date which is not a Business Day may be made on the next succeeding Business Day.

7.8 Currency. All payments under this Agreement shall be payable in US dollars. When conversion of payments from any foreign currency is required to be undertaken by Novartis, the USD equivalent shall be calculated using Novartis’ then-current standard exchange rate methodology as applied in its external reporting.

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7.9 Taxes. GW will pay any and all taxes levied on account of any payments made to it under this Agreement. Novartis hereby warrants to GW that as at the Effective Date there are no requirements under any applicable Laws to make any withholding or deductions in respect of any payments it is or will be required to make to GW pursuant to the terms of this Agreement and that it will make all such payments free of any such withholding or deduction in respect of tax unless and until there is a change to the applicable Laws which then requires Novartis to make a withholding or deduction for tax. Novartis will notify GW of any such change of applicable Laws. If any taxes are required to be withheld by Novartis, Novartis will: (a) deduct such taxes from the payment made to GW; (b) timely pay the taxes to the proper taxing authority; (c) send proof of payment to GW; and (d) reasonably assist GW in its efforts to obtain a credit for such tax payment. Each Party agrees to reasonably assist the other Party in lawfully claiming exemptions from and/or minimizing such deductions or withholdings under double taxation laws or similar circumstances; except that if Novartis is obliged by applicable Laws to make a deduction or withholding in respect of tax from any amount payable under this Agreement as a result of the failure by Novartis to complete any procedural formality necessary for it to obtain authorization to make a payment hereunder without the obligation to make a deduction or withholding, the amount due from Novartis to GW will be increased to an amount equal to the amount which, after making any deduction or withholding in respect of tax, leaves an amount equal to the payment which GW would have received if no deduction or withholding had been required.

7.10 Records. Each Party shall keep and procure that its Affiliates keep and, where applicable, sublicensees keep complete, true and accurate books and records in accordance with its Accounting Standards in sufficient detail for the other Party to determine the payments due and costs incurred under this Agreement. Each Party will keep such books and records, or procure such books and records are kept, for at least three (3) Calendar Years following the end of the fiscal year to which they pertain.

7.11 Audit Rights.

(a) For purposes of the audit rights described herein, the Party subject to an audit in any given year will be referred to as the “Auditee” and the other Party who has certain and respective rights to audit the books and records of the Auditee will be referred to as the “Audit Rights Holder” .

(b) Each Party may, upon written request and at its expense (except as provided for in Section 7.11(g)), cause an internationally-recognized independent accounting firm selected by it (except one to whom the Auditee has a reasonable objection), (the “Audit Team” ) to audit during ordinary business hours, at such place or places as they are customarily kept, the books and records of the other Party and its Affiliates for a given Calendar Year and the correctness of any payments made or required to be made to or by such Party during such Calendar Year under this Agreement, and any report underlying such payment (or lack thereof), pursuant to the terms of this Agreement. Prior to commencing its work pursuant to this Agreement, the Audit Team shall enter into an appropriate confidentiality agreement with the Auditee. In the event that Novartis has not audited the books of any Sublicensee of Novartis with respect to a given period and GW wishes Novartis to do so, (i) GW shall provide written notice of such request to Novartis, along with its preferred choice of auditor, (ii) Novartis shall inform the Sublicensee that it intends to exercise its audit rights, (iii) Novartis shall, in good faith, endeavour to use the auditor proposed by GW, subject to Sublicensee’s consent to use such auditor, if Sublicensee’s consent is required, (iv) GW shall agree with Novartis and the auditor the fees for the audit and such fees shall be fully payable by GW, and (v) Novartis shall provide GW with a report from the auditor which states whether or not the Net Sales

reported by the Sublicensee are correct and, if the reported Net Sales are incorrect, the amount of the discrepancy.

(c) In respect of each audit of the Auditee’s books and records: (i) the Auditee shall be audited not more frequently than once per year; (ii) no records for any given year for an Auditee may be audited more than once; and (iii) the Audit Rights Holder shall only be entitled to audit books and records of an Auditee from the three (3) Calendar Years prior to the Calendar Year in which the audit request is made.

(d) In order to initiate an audit for a particular Calendar Year, the Audit Rights Holder must provide written notice to the Auditee, which notice shall include one or more proposed dates for the audit and which notice shall be given not less than forty-five (45) days prior to the first proposed audit date. The Auditee will reasonably accommodate the scheduling of such audit. The Auditee shall provide the Audit Team(s) with full and complete access to the applicable books and records and otherwise reasonably cooperate with such audit.

(e) The Auditee shall have the right to request a further determination by such Audit Team as to matters which the Auditee disputes within thirty (30) days following receipt of such report. The Auditee will provide the Audit Rights Holder and the Audit Team with a reasonably detailed statement of the grounds upon which it disputes any findings in the audit report and the Audit Team shall undertake to complete such further determination within thirty (30) days after the dispute notice is provided, which determination shall be limited to the disputed matters. If the Parties disagree as to such further determination, the Parties agree that they shall use reasonable efforts, through the participation of finance representatives of both companies, to resolve any dispute arising in relation to any audit conducted hereunder by good faith discussion. If, despite using such good faith efforts, the Parties are unable to resolve an audit related dispute the Audit Rights Holder and the Auditee shall mutually select an internationally recognized independent accounting firm that shall make a final determination as to the remaining matters in dispute, which determination shall be binding upon the Parties.

(f) Neither the Audit Team, nor any accountants appointed under Section 7.11(e), shall disclose to the Audit Rights Holder any information relating to the business of the Auditee except that which should properly have been contained in any report required hereunder or is otherwise required to be disclosed to such Party to verify the payments required to be made pursuant to the terms of this Agreement.

(g) If the Parties discover, whether by audit or otherwise, that Novartis has made an overpayment, Novartis will deduct such overpayment in subsequent Sales & Royalty Reports for the following Calendar Quarters until the full amount that Novartis was entitled to receive is deducted, except that the maximum amount that may be deducted in a single Sales & Royalty Report is 50% of the royalties otherwise payable for the Calendar Quarter to which that report refers. If the full amount cannot be deducted from such subsequent amounts in the next four (4) quarters, GW shall promptly pay to Novartis the amount of any such overpayment within sixty (60) days of receiving an invoice from Novartis. If the Parties discover whether by audit or otherwise, that Novartis has made an underpayment, Novartis will add such underpayment to the Sales & Royalty Report for the following Calendar Quarter, except that the maximum amount that may be added in a single Sales & Royalty Report is ***% of the royalties otherwise payable for the Calendar Quarter to which that report refers.

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(h) Further, if the audit for any one or more Calendar Years shows an under-reporting or underpayment or an overcharge by the Auditee for that period in excess of *** percent (***%) of the amounts properly determined, the Auditee shall reimburse the Audit Rights Holder for its out-of-pocket expenses, including the fees and expenses paid by it to the Audit Team(s), in connection with said audit, which reimbursement shall be made within forty-five (45) days of receiving appropriate invoices and other support for such audit-related costs.

7.12 VAT. All payments to GW under the terms of the Agreement are expressed to be exclusive of all sales, service or value added taxes howsoever arising and Novartis shall pay to GW in addition to those payments all value added tax for which GW is liable to account to H M Revenue & Customs in relation to any supply made or deemed to be made for value added tax purposes to this Agreement on receipt of a tax invoice or invoices from GW.

7.13 Late Payments. If either Party fails to make any payment due to the other Party hereunder on the due date for payment and the payment is not in dispute between the Parties, or the dispute has not been resolved, then without prejudice to any other right or remedy available to the payee, the payee shall be entitled to charge the payor interest (but only after judgement) on the amount unpaid at the annual rate of twelve (12) month LIBOR plus *** per cent (***%) calculated on a daily basis until payment in full is made without prejudice to the payee’s right to receive payment on the due date.

8. INTELLECTUAL PROPERTY

8.1 Ownership, Prosecution and Maintenance.

(a) Except for the rights specifically granted by one Party to the other under this Agreement, both Parties will retain all title, rights, interest, and ownership in their respective Intellectual Property.

(b) Except as set forth in Section 8.2, GW will be responsible for, and shall use commercially reasonable efforts in, filing, prosecuting, maintaining and defending oppositions to the GW Patents and the GW Trademarks in the Territory and enforcing GW Trademarks in the Territory, including by conducting any necessary or desirable claims or proceedings (including but not limited to any interference, re-issue, re-examination, opposition or revocation proceeding) as follows:

(i) for those GW Patents which, at the Effective Date, are applications pending before a government Patent Office in a country in the Territory or which are granted in a county in the Territory, GW shall use commercially reasonable efforts to further prosecute, maintain and defend such GW Patents in such countries, at its own cost and expense;

(ii) for those GW Patents which are still at the PCT application phase at the Effective Date, when such PCT application(s) reach the national phase GW shall use commercially reasonable efforts to prosecute, maintain and defend oppositions to such GW Patents in the Key Countries, to the extent all of the Key Countries have been designated in the relevant PCT application at its own cost and expense. At Novartis’ request and expense, GW will use commercially reasonable efforts to prosecute, maintain and defend these Patent Rights in such additional PCT countries

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(iii) (additional to the Key Countries) in the Territory as Novartis may request. GW’s reasonable out-of-pocket costs in prosecuting, maintaining and defending oppositions to such Patent Rights in such additional PCT countries (additional to the Key Countries) in the Territory shall, subject to Section 8.1(b)(viii), be shared equally between the Parties and Novartis shall reimburse GW for its share of such out-of pocket costs as set forth in the final paragraph of this Section 8.1(b); and

(iv) in all future PCT applications made by GW which contain, or may give rise to, GW Patents, GW shall designate all countries within the Territory which are signatories to the Patent Cooperation Treaty and, when such PCT application reaches the national phase, GW shall use commercially reasonable efforts to prosecute, maintain and defend such GW Patents in the Key Countries at its own cost and expense. At Novartis’ request, GW will use commercially reasonable efforts to prosecute, maintain and defend these Patent Rights in such additional PCT countries additional to the Key Countries) in the Territory as Novartis may request at Novartis’ cost and expense. In addition, at the time of filing any future PCT application, GW shall also file corresponding applications in any Key Countries which are not PCT countries and in such other non-PCT countries in the Territory as Novartis may elect. GW’s reasonable out-of-pocket costs in prosecuting, maintaining and defending oppositions to such Patent Rights in such additional PCT countries (additional to the Key Countries) in the Territory and any non-PCT countries (other than any Key Countries which are not PCT countries) in the Territory shall, subject to Section 8.1(b)(viii), be shared equally between the Parties and Novartis shall reimburse GW for its share of such out-of pocket costs as set forth in the final paragraph of this Section 8.1(b);

(v) GW will use commercially reasonable efforts to further prosecute, maintain, defend and enforce the GW Trademarks listed in Exhibit A at its own cost and expense. In addition, GW will use commercially reasonable efforts to further prosecute, maintain, defend and enforce the GW Trademarks in such additional countries in the Territory as the Parties agree from time to time and Novartis shall reimburse GW for its reasonable out-of pocket costs in prosecuting, maintaining, defending and enforcing the GW Trademarks in such additional countries, as set forth in the final paragraph of this Section 8.1(b); and

(vi) GW will use commercially reasonable efforts to file, prosecute, maintain, defend and enforce any alternative GW Trademark agreed to pursuant to Section 6.3(a) in the Key Countries at its own cost and expense. In addition, GW will use commercially reasonable efforts to further prosecute, maintain, defend and enforce any such alternative GW Trademark in such additional countries in the Territory as the Parties agree from time to time and Novartis shall reimburse GW for its reasonable out-of pocket costs in prosecuting, maintaining, defending and enforcing such alternate GW Trademark in such additional countries, as set forth in the final paragraph of this Section 8.1(b).

(vii) GW will oppose any Third Party trademark requested by Novartis in the Key Countries at its own cost and expense where it is commercially reasonable for GW to do so and/or where such Third Party trademark may pose potential patient safety risks, namely the potential to contribute to medication errors. In addition, GW will use reasonable efforts to oppose any Third Party trademark requested by Novartis in such additional countries in the Territory as the Parties agree from time to time and Novartis shall reimburse GW for its reasonable out of pocket costs in opposing any

such Third Party trademark in such additional countries, as set forth in the final paragraph of this Section 8.1(b).

(viii) GW will consult with Novartis and keep Novartis reasonably informed of the status of each such GW Patent and GW Trademark and consider in good faith any written comments by Novartis with respect to any key decisions with respect thereto, such as any filings, oppositions or deviations from the prosecution model therefor. GW will also notify Novartis of any decision not to file applications for, or to cease prosecution and/or maintenance and/or defence of, or not to continue to pay the expenses of prosecution and/or maintenance and/or defence of, any GW Patents or GW Trademarks in any country in the Territory. GW will provide such notice at least thirty (30) days prior to any filing or payment due date, or any other due date that requires action, in connection with such Patent Right or trademark right. In such event, GW shall permit Novartis, at its sole discretion and expense, to file, re-file or to continue prosecution or maintenance of such GW Patent or GW Trademark. GW agrees, without additional consideration, to give all necessary consents, declarations and documentation as are reasonably required to implement the foregoing. Within thirty (30) days after each Calendar Quarter during which GW has incurred any out-of-pocket costs which are subject to reimbursement by Novartis under this Section 8.1(b), GW will provide to Novartis setting forth a detailed accounting of all such out-of-pocket costs, and shall submit an invoice to Novartis substantially in the form of Exhibit C with respect to the amount of such out-of-pocket costs. Unless disputed, Novartis shall pay such amount within sixty (60) days after receipt of such invoice.

(ix) In the event (a) Novartis gives GW a notice pursuant to Section 6.4(a) with respect to a country in which Novartis has required GW to file, prosecute, maintain and defend a GW Patent pursuant to Section 8.1(b)(ii) or 8.1(b)(iii), (b) Novartis has not submitted a Regulatory Filing for Marketing Approval of at least one Product in a non-Key Country with respect to which Novartis has required GW to file, prosecute, maintain and defend a GW Patent pursuant to Section 8.1(b)(ii) or 8.1(b)(iii) within three (3) years of the date on which it obtained the first Regulatory Approval of the first Product in a Key Country in the same Region; or (c) Novartis is deemed to have given GW notice pursuant to Section 6.4(c) with respect to a Region, GW shall cease to be obliged to further prosecute, maintain and defend such GW Patents in such country(ies)/Region(s) (as applicable in the circumstances) and Novartis shall reimburse GW the reasonable out-of-pocket costs incurred by GW in filing, prosecuting, maintaining and defending the GW Patents in such country(ies)/Region(s) (as applicable in the circumstances) to the point in time where GW’s obligation to file, prosecute, maintain and defend such GW Patent in such country/Region ceased.

(c) All Intellectual Property generated, developed or created by either Party arising out of or in connection with the performance of this Agreement ( “Resulting Intellectual Property” ) will belong to and vest the inventing Party, and the non-inventing Party will offer reasonable assistance, including providing any needed information and disclosures, to the inventing Party as needed to secure patent protection for Resulting Intellectual Property.

(d) Inventing Party will notify non-inventing Party of any decision not to file applications for, or to cease prosecution and/or maintenance of, or not to continue to pay the expenses of prosecution and/or maintenance of, Patent Rights filed for or obtained in any country in the Territory covering Resulting Intellectual Property at least thirty (30) days prior to any filing or payment due date, or any other due date that requires action, in connection with obtaining

patent protection. In such event, inventing Party shall permit non-inventing Party, at its sole discretion and expense, to file or to continue prosecution or maintenance of patents covering such Resulting Intellectual Property in the Territory.

8.2 Infringement Issues.

(a) Each Party will promptly notify the other of any infringement or mis-use in the Territory by a Third Party of any of the GW Technology, any GW Trademark, any Resulting Intellectual Property, or any data or market exclusivity rights Novartis may have in any country in the Territory in relation to the Product, of which it becomes aware (collectively “Third Party Infringement” ).

(b) Novartis will have the first right to bring and control any legal action in connection with the Third Party Infringement in the Territory, including any counterclaim for invalidity or unenforceability or any declaratory judgment action, where such Third Party Infringement is through the Commercialization by a Third Party of a Competitive Product at its own expense as it reasonably determines appropriate. Where Novartis decides to commence proceedings, Novartis shall be entitled to require GW to join Novartis as co-plaintiff in the prosecution of a Third Party Infringement. In such case GW shall provide all necessary assistance to Novartis in relation to any such proceedings and Novartis shall, on demand reimburse GW for all out-of-pockets costs arising from such activity. Notwithstanding the foregoing, where GW is not required to join Novartis as a co-plaintiff, GW shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If Novartis fails to either (i) bring an action or proceeding with respect to, or (ii) otherwise terminate, such infringement or mis-use of, any GW Technology or GW Trademarks (A) within one hundred twenty (120) days following the notice of alleged infringement or (B) prior to ten (10) days before the time limit, if any, set forth in the appropriate Laws and regulations for the filing of such actions, whichever comes first, GW shall have the right, upon written approval of Novartis, to bring and control any such action at its own expense and by counsel of its own choice. Where GW decides to commence proceedings in relation to GW Technology or GW Trademarks, GW shall be entitled to require Novartis to join GW as co-plaintiff. In such case Novartis shall provide all necessary assistance to GW in relation to any such proceedings and GW shall, on demand reimburse Novartis for all out-of-pockets costs arising from such activity. In all other circumstances Novartis shall have the right, at its own expense, to be represented in any such action by counsel of its own choice; provided , however , that if Novartis notifies GW in writing prior to ten (10) days before such time limit for the filing of any such action that Novartis intends to file such action before the time limit, then Novartis shall be obligated to file such action before the time limit, and GW will not have the right to bring and control such action.

(c) In connection with any such proceeding, Novartis shall not enter into any settlement admitting the invalidity of, or otherwise impairing GW’s rights in, the GW Technology or GW Trademarks without the prior written consent of GW, which will not be unreasonably withheld or delayed.

(d) Any recoveries resulting from such an action relating to a claim of Third Party Infringement shall be first applied against payment of each Party’s costs and expenses in connection therewith. In the event that Novartis brought such action, any remainder will be retained by (or if received by GW, paid to) Novartis; provided , however , that the remainder shall be subject to a royalty payment to GW as if such amount was Net Sales under this Agreement. In the event that GW brought such action, any remainder shall be retained by GW, unless Novartis was joined as a party to such action, in which case the remainder shall be shared in the ratio of one-third to Novartis and two-thirds to GW.

8.3 Patent extensions. If requested by Novartis, GW shall cooperate in obtaining patent term restoration, supplemental protection certificates or their equivalents, and patent term extensions with respect to the GW Patents in any country and/or region in the Territory where applicable. GW shall provide all reasonable assistance requested by Novartis, including permitting Novartis to proceed with applications for such in the name of GW, if deemed appropriate by Novartis, and executing documents and providing any relevant information to Novartis. Novartis shall in its sole discretion determine which, if any, GW Patents it will apply to extend.

9. CONFIDENTIALITY

9.1 Duty of Confidence. Subject to the other provisions of this Article 9, all Confidential Information disclosed by a Party or its Affiliates under this Agreement will be maintained in confidence and otherwise safeguarded by the recipient Party and its Affiliates. The recipient Party may only use the Confidential Information for the purposes of this Agreement and pursuant to the rights granted to the recipient party under this Agreement. Subject to the other provisions of this Article 9, each Party will hold as confidential such Confidential Information of the other Party or its Affiliates in the same manner and with the same protection as such recipient Party maintains its own confidential information and with at least a reasonable degree of care. Subject to the other provisions of this Article 9, a recipient Party may only disclose Confidential Information of the other Party to employees, agents, contractors, consultants, insurers, and advisers of the Party and its Affiliates and Sublicensees and to Third Parties to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, this Agreement; provided that such Persons are bound to maintain the confidentiality of the Confidential Information in a manner consistent with the confidentiality provisions of this Agreement.

9.2 Exceptions. The obligations under Section 9.1 above will not apply to any information to the extent the recipient Party can demonstrate by competent evidence that such information:

(a) is (at the time of disclosure) or becomes (after the time of disclosure) known to the public or part of the public domain through no breach of this Agreement by the recipient Party or its Affiliates;

(b) was known to, or was otherwise in the possession of, the recipient Party or its Affiliates prior to the time of disclosure by the disclosing Party or any of its Affiliates;

(c) is disclosed to the recipient Party or an Affiliate on a non-confidential basis by a Third Party who is entitled to disclose it without breaching any confidentiality obligation to the disclosing Party or any of its Affiliates; or

(d) is independently developed by or on behalf of the recipient Party or its Affiliates, as evidenced by its written records, without reference to the Confidential Information disclosed by the disclosing Party or its Affiliates under this Agreement.

Specific aspects or details of Confidential Information will not be deemed to be within the public domain or in the possession of the recipient Party merely because the Confidential Information is embraced by more general information in the public domain or in the possession of the recipient Party. Further, any combination of Confidential Information will not be considered in the public domain or in the possession of the recipient Party merely because individual elements of such Confidential Information are in the public domain or in the possession of the recipient Party unless the combination and its principles are in the public domain or in the possession of the recipient Party.

9.3 Authorized Disclosures.

In addition to the disclosures allowed under Section 9.2:

(a) Novartis, its Affiliates and Sublicensees may disclose Confidential Information disclosed under this Agreement to the extent such disclosure is necessary in the following instances: (i) filing or prosecuting Patent Rights in the Territory as contemplated by this Agreement; (ii) in connection with Regulatory Filings for Products in the Territory; or (iii) to the extent otherwise necessary or appropriate in connection with exercising the license and other rights granted to Novartis hereunder.

(b) Novartis and its Affiliates may disclose Confidential Information of GW to Third Parties as may be necessary or useful in connection with the registration or Commercialization of Product(s) as contemplated by this Agreement, including in connection with Sublicensing and Subcontracting transactions, provided such Third Parties are obligated to substantially the same extent as set forth in Section 9.1 to hold in confidence and not use for such Confidential Information for any purpose other than those permitted by this Agreement.

(c) GW and its Affiliates may disclose Confidential Information disclosed under this Agreement: (i) to its actual or potential investment bankers; (ii) to its existing and potential investors, other than Novartis Competitors, in connection with an offering or placement of securities for purposes of obtaining financing for its business and to actual and prospective lenders, other than Novartis Competitors, for the purpose of obtaining financing for its business; and (iii) to a bona fide potential acquirer or merger partner, other than any Novartis Competitor, for the purposes of evaluating entering into a merger or acquisition, provided , however , that in each case any such persons must be obligated to substantially the same extent as set forth in Section 9.1 to hold in confidence and not make use of such Confidential Information for any purpose other than assessing a potential investment in, financing of, or acquisition of or merger with GW. With respect to any existing and potential investor, actual and prospective lender or bona fide potential acquirer or merger partner of GW which is a Novartis Competitor, GW may disclose a copy of this Agreement from which the financial provisions have been redacted together with other Confidential Information of a non-financial nature disclosed under this Agreement (other than the Commercialization Plans) to the Novartis Competitor and an unredacted copy of this Agreement, together with other Confidential Information of a financial nature disclosed under this Agreement, to a Third Party adviser to any such Novartis Competitor, which adviser may not disclose any terms of this Agreement or any such financial information to such Novartis Competitor, but shall be permitted to assess the valuation assumptions of such Novartis Competitor in view of such terms and financial information and advise such Novartis Competitor whether the financial value of this Agreement to GW, taken as a whole, is materially consistent with (or materially inferior or superior to) the assumptions made by such Novartis Competitor; provided , however , that in each case any such Third Party adviser has entered into a written confidentiality agreement under which it is obligated to substantially the same extent as set forth in Section 9.1 to hold in confidence and not make use of such Confidential Information for any purpose other than the foregoing.

(d) Either Party may disclose Confidential Information disclosed to it under this Agreement to the extent such disclosure is necessary in the following instances: (i) prosecuting or defending litigation as contemplated by this Agreement; or (ii) complying with applicable court orders or governmental regulations;

(e) In the event the recipient Party is required to disclose Confidential Information of the disclosing Party in connection with bona fide legal process, such disclosure shall not be a

breach of this Agreement; provided that the recipient Party (i) informs the disclosing Party as soon as reasonably practicable of the required disclosure; (ii) limits the disclosure to the required purpose; and (iii) at the disclosing Party’s request and expense, assists in an attempt to object to or limit the required disclosure.

9.4 Ongoing Obligation for Confidentiality. The confidentiality obligations of each Party under this Agreement shall continue for the longer of: (a) fifteen (15) years following the Effective Date; and (b) a period of ten (10) years beyond the first to occur of the following: (i) termination of this Agreement (where it is terminated by (A) GW pursuant to Section 10.2, 10.3 or 10.6, or (B) Novartis pursuant to Section 10.4), (ii) expiration of this Agreement, or (iii) where the Agreement is terminated by Novartis pursuant to Section 10.2 or 10.3, the date on which Novartis, its Affiliates and Sublicensees cease to Commercialize a Product anywhere in the Territory. Upon expiry of the ongoing obligation for confidentiality under this Section 9.4, each Party, its Affiliates and (sub)licensees will immediately return to the other Party or destroy any Confidential Information disclosed by the other Party and any document containing the same, except for one copy which may be retained in its confidential files for archive purposes.

9.5 Publicity Related to this Agreement. Other than the press release pertaining to this transaction, and save as permitted in Section 9.7, each Party agrees not to issue any press release or other public statement, whether oral or written, disclosing the existence of this Agreement, the terms hereof or any information relating to this Agreement without the prior written consent of the other Party.

9.6 Use of Names. Neither Party shall use the name, symbol, trademark, trade name or logo of the other Party or its Affiliates in any press release, publication or other form of public disclosure without the prior written consent of the other Party in each instance (such consent not to be unreasonably withheld or delayed), except for those disclosures for which consent has already been obtained.

9.7 Disclosures Required By Law. Each Party may make any disclosures required of it to comply with any duty of disclosure it may have pursuant to law or governmental regulation or pursuant to the rules of any recognized stock exchange. In the event of a disclosure required by law, governmental regulation or the rules of any recognized stock exchange, the Parties shall coordinate with each other with respect to the timing, form and content of such required disclosure. If so requested by the other Party, the Party subject to such obligation shall use commercially reasonable efforts to obtain an order protecting to the maximum extent possible the confidentiality of such provisions of this Agreement as reasonably requested by the other Party at the other Party’s cost. If the Parties are unable to agree on the form or content of any required disclosure, such disclosure shall be limited to the minimum required as determined by the disclosing Party in consultation with its legal counsel. Without limiting the foregoing, each Party shall consult with the other Party on the provisions of this Agreement, together with exhibits or other attachments attached hereto, to be redacted in any filings made by GW or Novartis with the Securities and Exchange Commission (or other regulatory body) or as otherwise required by law.

9.8 No Liability for Public Disclosures by Other Party. Notwithstanding any other provision of this Agreement, neither Party shall have any liability or other obligation (either to the other Party or to any other Person) with respect to any press release, publication or other form of public disclosure or statement of the other Party.

10. TERM AND TERMINATION

10.1 Term. This Agreement will commence on the Effective Date and continue on a country-by-country basis for the commercial life of the Products (the “Term” ), unless otherwise terminated in accordance with the terms of this Agreement.

10.2 Termination for Cause. If either Novartis or GW is in material breach of this Agreement, the non-breaching Party may give written notice to the breaching Party specifying the claimed particulars of such breach, and in the event such material breach is not cured within ninety (90) days after such notice, the non-breaching Party shall have the right thereafter to terminate this Agreement immediately by giving written notice to the breaching Party to such effect; provided , however , that if such breach is capable of being cured but cannot be cured within such ninety (90) day period and the breaching Party initiates actions to cure such breach within such period and thereafter diligently pursues such actions, the breaching Party shall have such additional period as is reasonable in the circumstances to cure such breach. In the event that arbitration is commenced with respect to any alleged breach hereunder pursuant to Section 14.4(b), no purported termination of this Agreement pursuant to this Section 10.2 shall take effect until the resolution of such arbitration. Any termination by any Party under this Section 10.2 and the effects of termination provided herein shall be without prejudice to any damages or other legal or equitable remedies to which it may be entitled from the other Party.

10.3 Termination for Insolvency. Either GW or Novartis may terminate this Agreement without notice if an Insolvency Event occurs in relation to the other Party. In any event when a Party first becomes aware of the likely occurrence of any Insolvency Event in regard to that Party, it shall promptly so notify the other Party in sufficient time to give the other Party sufficient notice to protect its interests under this Agreement.

10.4 Termination by Novartis Without Cause. Novartis may terminate this Agreement without cause at any time after the Effective Date in its entirety or country-by-country basis at any time on sixty (60) days prior written notice.

10.5 Rights in Bankruptcy. In the event of the occurrence of an Insolvency Proceeding pertaining to GW:

(a) Novartis shall have the option to acquire ownership of the entire right, title, and interest of GW in the GW Patent Rights and GW Trademarks in the Territory and the GW Technology specific to the Territory and to acquire a fully paid up exclusive sub-licensable licence under other GW Technology such licence to be for use in the Territory (the “Intangible Rights” ). GW shall provide prompt notice to Novartis of the appointment of an Insolvency Officer or the commencement of an Insolvency Proceeding by or against GW under the insolvency laws of any jurisdiction. The option shall be exercisable by notice (the “Option Notice” ) at any time during the sixty (60) day period following such event from Novartis to GW of Novartis’ intent to exercise the option. Novartis shall nominate three prospective appraisers of recognized repute, and the Insolvency Officer shall select one of them for the purpose of appraising the Intangible Rights. The appraiser shall value the Intangible Rights at fair market value at the time of appraisal using the valuation technique believed by such appraiser to be most appropriate under the circumstances. The appraisal report shall be prepared and distributed to Novartis and the Insolvency Officer within thirty (30) days of engagement of the appraiser. Novartis shall thereafter have thirty (30) days within which to provide notice (the “Option Exercise Notice” ) to the Insolvency Officer of its exercise of the option to acquire the Intangible Rights. Novartis and GW shall cooperate and act in good faith in respect of the exercise of the option and shall use every reasonable effort to cause the sale of the Intangible Rights to close within thirty (30) days following the Option Exercise Notice. If Novartis does not provide an Option Exercise Notice, the fees and expenses of the Appraiser shall be born by Novartis. If Novartis exercises the option, the fees and expenses of the Appraiser shall be shared equally by Novartis and GW.

(b) Novartis will be entitled to a complete duplicate of (or complete access to, as appropriate) the GW Technology and all embodiments of the GW Technology, and same, if not already in its possession, will be promptly delivered to it.

10.6 No Challenge. GW shall have the right to give thirty (30) days) notice of termination of this Agreement in writing to Novartis if at any time Novartis or any of its Affiliates involved in the registration or Commercialization of Products hereunder challenges, directs a Third Party to challenge or knowingly assists a Third Party in challenging the validity or enforceability of:

(a) any GW Patents in the Territory; or

(b) any GW Trademarks in the Territory,

and this Agreement shall terminate upon expiration of such thirty (30) days notice period. Novartis shall use Commercially Reasonable Efforts to include a like right of termination for Novartis in any sublicense agreement relating to one or more Products entered into by Novartis following the Effective Date. For the purposes of this Section 10.6 a Third Party is any Person other than Novartis and those of its Affiliates involved in the registration or Commercialization of Products hereunder.

11. EFFECTS OF TERMINATION

11.1 Termination by Novartis for Cause. Upon termination of this Agreement by Novartis pursuant to Sections 10.2 or 10.3:

(a) the license granted to GW pursuant to Section 2.1(f) shall continue with respect to the Resulting Intellectual Property Controlled by Novartis at the effective date of termination, but at Novartis’ election (such election to be notified to GW in writing) the license granted to GW pursuant to Section 2.1(f) shall terminate with respect to Resulting Intellectual Property which comes under Novartis’ Control after the effective date of termination;

(b) the licenses and other rights granted by GW to Novartis will remain in effect in accordance with their respective terms; provided , however , that (i) the licenses granted to Novartis in Article 2 shall become perpetual and irrevocable licenses, (ii) in the case of a termination under Section 10.2, the amount of any Milestone Payments and royalties applicable to Net Sales of Product shall be reduced to fifty percent (50%) of the amounts set forth in Article 7, and (ii) in the case of a termination under Section 10.2 Novartis shall have the right to offset the full amount of any damages awarded pursuant to any arbitration conducted under Section 14.4 against future Milestone Payments and/or royalties;

(d) GW’s obligations under Articles 4 will remain in full force and effect;

(e) GW’s obligations under Article S and the ensuing Manufacturing and Supply Agreement will remain in full force and effect; and

(f) Sections 2.2, 2.4, 6.3, 7 (subject to Section 11.1(b)(ii)), 8, 9, 11.1, 13 and 14 shall survive in accordance with their terms.

11.2 Termination by GW for Cause or by Novartis Without Cause. Upon termination of this Agreement by GW pursuant to Sections 10.2, 10.3 or 10.6, or by Novartis pursuant to Section 10.4:

(a) Any licenses and other rights granted by GW to Novartis will terminate and revert to GW;

(b) Notwithstanding the provisions of Section 7.2, no Milestone Payments shall be payable by Novartis during any period during which notice has been given by Novartis under Section 10.4 or by GW under Section 10.2, 10.3 or 10.5;

(c) during any period during which notice has been given by Novartis under Section 10.4 or by GW under Section 10.2, 10.3 or 10.5, Novartis, its Affiliates and Sublicensees shall reasonably cooperate with GW transitioning the registration of the Products in the Territory back to GW; and

(d) commensurate with legislative and regulatory requirements, Novartis shall as soon as practicably possible after termination transfer to GW or its nominee all right, title and interest in all relevant Regulatory Filings or Regulatory Approvals held by Novartis or any of its Affiliates or Sublicensees for any Product(s) (together the “Product Registrations” ), and Novartis shall execute (and ensure its Affiliates and Sublicensees execute) all necessary and appropriate letters to the Regulatory Authorities in the Territory (if any) requested by GW to ensure that ownership of the Product Registrations are transferred to GW within ninety (90) days of termination. In addition, Novartis shall provide GW with copies of all filings and correspondence that are submitted to any Regulatory Authority to the extent they relate to all relevant Product(s) in the Territory;

(e) Novartis shall grant to GW an exclusive, perpetual, irrevocable, fully paid-up, sublicensable license under (i) the data generated by Novartis and its Affiliates’ in the conduct of any Phase IV clinical study with respect to the Product in the Territory, and (ii) the copyright and trade dress rights in the marketing, advertising and promotional materials used by Novartis and its Affiliates to Commercialize the Products in the Territory, to make and have made Regulatory Filings, import, have imported, use, have used, Commercialize and have Commercialized any Product in the Territory. Expressly excluded from the foregoing license is the right for GW to use the Novartis Marks;

(f) as soon as practicably possible but no later than ninety (90) days following the termination date Novartis shall transfer to GW (together with all right, title and interest in the same) any and all marketing, advertising and promotional documents and materials developed by Novartis and its Affiliates during the term of this Agreement for use in Commercializing the Products, which may only be used in accordance with the licence granted under Section 11.2(e) above;

(g) as soon as practicably possible but no later than ninety (90) days following the termination date, Novartis shall transfer to GW any registrations for domain names owned or Controlled by Novartis, its Affiliates or Sublicensees which correspond to or include any GW Trademark for Product;

(h) Novartis shall have the right to sell Product which is the subject of pre-termination date orders that are binding on Novartis or its Affiliates (including periodic forecasts the first period of which is binding where any such period is one Calendar Quarter or less) and at the end of such Calendar Quarter, Novartis shall report on the location of any and all stocks of Product in the possession, power, custody or control of Novartis or its Affiliates or Sublicensees (the amount of stock being “Inventory” ). At such time GW may elect (by giving Novartis notice in writing within fifteen (15) days of receipt of Novartis’ inventory report) to purchase the Inventory from Novartis at Novartis’s Direct Manufacturing Costs (as defined in Exhibit F, and which definition shall apply as if Novartis is GW). To the extent that any Novartis mark (including, without limitation, as part of any of the corporate or trading names of any Affiliate of Novartis) has already been affixed by Novartis on Product within Inventory, GW shall not use, sell or offer for sale any such Inventory unless and until all such references to Novartis have been appropriately over-stickered. If GW does not elect to buy the Inventory within the fifteen (15) day period specified above, to the extent that Novartis, its Affiliates or Sublicensees have entered into binding agreements with one or more Third Parties to supply one or more Products and such agreements remain in effect

beyond such termination, Novartis shall have the right to sell Product from Inventory (and the Parties’ rights and obligations under this Agreement shall remain in force and effect to the extent, and for so long as, necessary) for Novartis, its Affiliates and/or Sublicensees to fulfill their obligations under such Third Party agreement(s).

(i) other than as set forth in (f) above, on and after the termination date, Novartis shall deliver to GW all purchase orders for Product received by Novartis; and

(j) Sections 2.1(f), 8.1(a), 8.1(c), 9, 11.2, 13 and 14 shall survive and shall continue to apply. In the event that this Agreement is terminated with respect to only certain country(ies), the provisions of this Section 11.2 shall apply only with respect to the terminated country(ies), as applicable.

11.3 Survival. Termination or expiration of this Agreement will not relieve either Party of any obligation accruing prior to expiration or termination, including any breach of such obligations.

12. REPRESENTATIONS, WARRANTIES AND COVENANTS

12.1 Representations and Warranties by Each Party. Each Party represents and warrants to the other as of the Effective Date that:

(a) it is a corporation duly organized, validly existing, and in good standing under the Laws of its jurisdiction of formation;

(b) it has full corporate power and authority to execute, deliver, and perform this Agreement, and has taken all corporate action required by law and its organizational documents to authorize the execution and delivery of this Agreement and the consummation of the transactions contemplated by this Agreement;

(d) all consents, approvals and authorizations from all governmental authorities or other Third Parties required to be obtained by such Party in connection with this Agreement have been obtained; and

(e) the execution and delivery of this Agreement and all other instruments and documents required to be executed pursuant to this Agreement, and the consummation of the transactions contemplated hereby and thereby do not and shall not (i) conflict with or result in a breach of any provision of its organizational documents, ii) result in a breach of any agreement to which it is a party, or (iii) violate any law.

12.2 Representations and Warranties by GW. GW represents and warrants to Novartis as of the Effective Date that:

(a) Exhibit A sets forth a complete and accurate list of (i) all GW Patents in existence in the Territory as of the Effective Date, indicating the owner, licensor and/or co-owner(s) thereof if any such GW Patent is not solely owned by GW; (ii) all registrations of, or applications for registrations of, GW Trademarks in existence in the Territory as of the Effective Date, indicating the owner, licensor and/or co-owner(s) thereof if any such GW Trademark is not solely owned by GW; and (iii) all license, assignment, distribution or other agreements relating to the GW Patents and GW Know-How in the Territory and all license, assignment,

distribution, co-existence, prior rights or other agreements relating to the GW Trademarks in the Territory;

(b) GW is the sole and exclusive owner, or exclusive licensee of all of the GW Patents and GW Trademarks listed in Exhibit A free from Encumbrances and is listed in the records of the appropriate governmental agencies as the sole and exclusive owner of record or exclusive licensee for each registration, grant and application included in the GW Patents and GW Trademarks listed in Exhibit A;

(c) all of its employees, officers, and consultants who are or have been involved with the Development of Sativex prior to the Effective Date have executed agreements or have existing obligations under applicable Laws requiring assignment to GW of all inventions made during the course of and as the result of the performance of their obligations to GW and obligating them to maintain as confidential GW’s Confidential Information as well as confidential information of other parties (including Novartis and its Affiliates) which such individual may receive from GW in the course of its employment/engagement by GW, to the extent required to support GW’s obligations under this Agreement;

(d) GW has the right to grant to Novartis for the Territory the licenses under the GW Technology and GW Trademarks that it purports to grant hereunder;

(e) GW has the right to use and disclose and to enable Novartis to use and disclose in the Territory (in each case under appropriate conditions of confidentiality) the Know-How within GW Technology free from Encumbrances in the Territory;

(f) to the knowledge of GW, (i) there is no material reason why any of the GW Patents listed on Exhibit A which are granted are or might be invalid or unenforceable, and (ii) n respect of the pending patent applications included within the GW Patents listed on Exhibit A, GW has presented all relevant prior art of which it and the inventors are aware to the relevant patent examiners at the relevant patent offices in the Territory;

(g) all application, registration, maintenance and renewal fees in respect of the GW Patents and GW Trademarks listed in Exhibit A have been paid and all necessary documents and certificates have been filed with the relevant agencies for the purpose of maintaining such GW Patents and GW Trademarks;

(h) to the knowledge of GW, neither the registration, use or Commercialization of any Product in the Territory, nor the manufacture of any Product anywhere in the world where it is manufactured or anywhere in the Territory by or on behalf of GW at the Effective Date, infringes the Intellectual Property rights or misappropriates the Know-How of any Third Party;

(i) other than with respect to Novartis’ AG’s SATIXEO trademark, GW has not initiated or been involved in any proceedings or claims in the Territory in which it alleges that any Third Party is or was infringing or misappropriating any GW Technology or GW Trademark, nor have any such proceedings been threatened by GW, nor does GW know of any valid basis for any such proceedings;

(j) GW has taken all reasonable precautions to preserve the confidentiality of the GW Know-How;

(k) GW has not granted any Third Party rights that would otherwise interfere or be inconsistent with Novartis’ rights hereunder, and there are no agreements or arrangements to which GW

or any of its Affiliates is a party relating to the Products, GW Technology or GW Trademarks that would limit the rights granted to Novartis under this Agreement or that restrict or will result in a restriction on Novartis’ ability to register, use or Commercialize the Products in the Territory;

(l) neither GW nor any of its Affiliate has committed any act which amounts to a material breach of any of GW’s obligations under any agreement under which it obtains rights to any of the GW Technology or any plant breeders rights or plant variety rights used in the growing or manufacture of any Product;

(m) GW owns and Controls the registration dossier for Sativex in the European Union and all data and other Know-How included therein;

(n) Conditional on Novartis’ compliance with Section 2.1(f), GW has not granted a Third Party the right to make any formulation improvement to a Product or to develop a Product for new indications without GW retaining the right to (sub)license Novartis to use any such formulation improvement to a Product in the Territory or to Commercialize Product for new indication in the Territory;

(o) conditional on Novartis’ compliance with Section 2.1(f), GW has the right to access, and to grant similar access to Novartis for use in the Territory, all data related to any Product which is generated by its licensees of Products outside the Territory;

(p) GW has disclosed to Novartis all material information in its Control in response to any and all questions asked by Novartis during the due diligence investigations prior to the Effective Date. The materials and information provided by GW to Novartis (whether prepared by GW or any Third Party) in response to any and all such questions asked by Novartis do not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained therein, in the light of the circumstances under which they were made, not misleading. Notwithstanding anything to the contrary contained in this Agreement, GW has not failed to disclose to Novartis any fact or circumstance known to GW and relating to any of the GW Products that GW reasonably believes would be reasonably material to any reasonable distributor or licensee entering into this Agreement; and

(q) None of the Otsuka Patents covers, or contains any basis to give rise to a granted right covering, Product (including Back up Product) for the treatment of (1) MS and/or Spasticity in MS; or (2) cancer pain.

12.3 Covenants.

(a) GW covenants and agrees that during the Term:

(i) it will not grant any interest in the GW Technology or GW Trademarks which is inconsistent with the terms and conditions of this Agreement, nor shall GW assign its right, title or interest in or to the GW Technology or the GW Trademarks to any Third Party other than in accordance with Section 14.1;

(ii) it will use all reasonable precautions to preserve the confidentiality of the Know-How within GW Technology;

(iii) it will not amend or modify the terms of any agreement under which it obtains rights to any of the GW Technology in a manner in which adversely affects the rights

granted to Novartis under the GW Technology in the Territory without the prior written consent of Novartis;

(iv) GW and its Affiliates will comply with, perform and observe in all material respects all obligations under each agreement under which it obtains rights to any of the GW Technology licensed to Novartis hereunder, and will not commit any act or fail to perform any obligation which would amount to a default or event of default or which, with the giving of notice, the lapse of time or the happening of any other event or condition would become a default or event of default thereunder or give rise to any right to terminate any such agreement or any part thereof;

(v) GW will continue to Control the registration dossiers for all Products in the European Union and all data and other Know-How included therein;

(vi) GW will not grant any Third Party (including any licensee of any Product outside the Territory) the right to make any improvement to any Product;

(vii) GW will continue to have the right to access, and to grant similar access to Novartis for use in the Territory, all data related to any Product which is generated by its licensees of Products outside the Territory;

(viii) all substantive materials to be provided by GW to Novartis (whether prepared by GW or any Third Party, other than any Regulatory Authority) pursuant to Section 6.1(e)(i) and (ii) will not contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not misleading;

(ix) if, at any time after execution of this Agreement, it becomes aware that it or any employee, agent or subcontractor of GW who participated, or is participating, in the performance of any activities hereunder is on, or is being added to the FDA Debarment List or any of the FDA clinical investigator enforcement lists (including the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List), it will provide written notice of this to Novartis within two (2) Business Days of its becoming aware of this fact; and

(x) it shall maintain insurance with respect to its activities and obligations under this Agreement in such amounts as are commercially reasonable in the industry for companies conducting similar business and shall require any of its Affiliates undertaking activities under this Agreement to do the same.

12.4 No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 12 AND THE MANUFACTURING AND SUPPLY AGREEMENT, (A) NO REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF NOVARTIS OR GW UNDER THIS AGREEMENT; AND (B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE HEREBY EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT.

13. INDEMNIFICATION; LIABILITY

13.1 Indemnification by GW. GW shall indemnify and hold Novartis, its Affiliates and sublicensees, and their respective officers, directors and employees (“Novartis Indemnitees”) harmless from and against any Claims against them to the extent arising or resulting from:

(a) GW’s, or any of its Affiliates’, licensees’ or contractors’ actions in connection with either (i) the Development of the Products anywhere in the world, or (ii) the Commercialization of the Products outside the Territory;

(b) the negligence or willful misconduct of GW or any of its Affiliates or licensees; or

(c) the breach of any of the covenants, warranties or representations made by GW to Novartis under Article 12 of this Agreement; or

(d) resulting from any allegation of a Third Party that either (i) the activities of Novartis, its Affiliates or Sublicensees under this Agreement with a Product in a particular country in the Territory; or (ii) the manufacture of Products by or on behalf of GW where it is actually manufactured or in the Territory, infringe any Patent Rights (in the form ultimately issued) issuing from patent application *** in the country in which such activity occurs;

(e) resulting from any allegation of a Third Party that either (i) the activities of Novartis, its Affiliates or Sublicensees under this Agreement with a Product in a particular country in the Territory; or (ii) the manufacture of Products by or on behalf of GW where it is actually manufactured or in the Territory, infringe or misappropriate any Relevant Third Party Right for which GW has determined access (through a license or otherwise) is not required or to which GW has failed to obtain such access by license or otherwise such that the Relevant Third Party Right is Controlled by GW and included in the licenses granted to Novartis under Section 2.1;

provided , however , that GW shall not be obliged to so indemnify, defend and hold harmless the Novartis Indemnitees for any Claims for which Novartis has an obligation to indemnify GW Indemnitees pursuant to Section 13.2.

13.2 Indemnification by Novartis. Novartis shall indemnify and hold GW, its Affiliates, and their respective officers, directors and employees ( “GW Indemnitees” ) harmless from and against any Claims against them to the extent arising or resulting from:

(a) Novartis’, or any of its Affiliates’, Sublicensees’ or Subcontractors’ actions in connection with (i) filing for, obtaining and/or maintaining Regulatory Approvals for Products in the Territory (ii) packaging and labeling and shipping of Product in the Territory and/or (iii) the Commercialization of the Products in the Territory

(b) the negligence or willful misconduct of Novartis or any of its Affiliates or Sublicensees; or

(c) the breach of any of the covenants, warranties or representations made by Novartis to GW under Article 12 of this Agreement;

provided , however , that Novartis shall not be obliged to so indemnify, defend and hold harmless the GW Indemnitees for any Claims for which GW has an obligation to indemnify Novartis Indemnitees pursuant to Section 13.1 or under the Manufacturing and Supply Agreement.

13.3 Indemnification Procedure.

(a) For the avoidance of doubt, all indemnification claims in respect of a Novartis Indemnitee or GW Indemnitee shall be made solely by Novartis or GW, respectively.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

(b) A Party seeking indemnification hereunder ( “Indemnified Party” ) shall notify the other Party ( “Indemnifying Party” ) in writing reasonably promptly after the assertion against the Indemnified Party of any Claim or fact in respect of which the Indemnified Party intends to base a claim for indemnification hereunder ( “Indemnification Claim Notice” ), but the failure or delay to so notify the Indemnifying Party shall not relieve the Indemnifying Party of any obligation or liability that it may have to the Indemnified Party, except to the extent that the Indemnifying Party demonstrates that its ability to defend or resolve such Claim is adversely affected thereby. The Indemnification Claim Notice shall contain a description of the claim and the nature and amount of the Claim (to the extent that the nature and amount of such Claim is known at such time). Upon the request of the Indemnifying Party, the Indemnified Party shall furnish promptly to the Indemnifying Party copies of all correspondence, communications and official documents (including court documents) received or sent in respect of such Claim.

(c) Subject to the provisions of sub-Sections (d) and (e) below, the Indemnifying Party shall have the right, upon written notice given to the Indemnified Party, within thirty (30) days after receipt of the Indemnification Claim Notice to assume the defense and handling of such Claim, at the Indemnifying Party’s sole expense, in which case the provisions of sub-Section (d) below shall govern. The assumption of the defense of a Claim by the Indemnifying Party shall not be construed as acknowledgement that the Indemnifying Party is liable to indemnify any indemnitee in respect of the Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification. In the event that it is ultimately decided that the Indemnifying Party is not obligated to indemnify or hold an Indemnitee harmless from and against the Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all costs and expenses (including attorneys’ fees and costs of suit) and any losses incurred by the Indemnifying Party in its defense of the Claim. If the Indemnifying Party does not give written notice to the Indemnified Party, within thirty (30) days after receipt of the Indemnification Claim Notice, of the Indemnifying Party’s election to assume the defense and handling of such Claim, the provisions of sub-Section (e) below shall govern.

(d) Upon assumption of the defense of a Claim by the Indemnifying Party: (i) the Indemnifying Party shall have the right to and shall assume sole control and responsibility for dealing with the Claim; (ii) the Indemnifying Party may, at its own cost, appoint as counsel in connection with conducting the defense and handling of such Claim any law firm or counsel reasonably selected by the Indemnifying Party; (iii) the Indemnifying Party shall keep the Indemnified Party informed of the status of such Claim; and (iv) the Indemnifying Party shall have the right to settle the Claim on any terms the Indemnifying Party chooses; provided , however , that it shall not, without the prior written consent of the Indemnified Party, agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of the Indemnified Party for which the Indemnified Party is not entitled to indemnification hereunder or which admits any wrongdoing or responsibility for the claim on behalf of the Indemnified Party. The Indemnified Party shall cooperate with the Indemnifying Party and shall be entitled to participate in, but not control, the defense of such Claim with its own counsel and at its own expense. In particular, the Indemnified Party shall furnish such records, information and testimony, provide witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours by the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Claim, and making the Indemnified Party, the indemnitees and its and their employees and agents available on a

mutually convenient basis to provide additional information and explanation of any records or information provided.

(e) If the Indemnifying Party does not give written notice to the Indemnified Party as set forth in sub-Section (c) or fails to conduct the defense and handling of any Claim in good faith after having assumed such, the Indemnified Party may, at the Indemnifying Party’s expense, select counsel reasonably acceptable to the Indemnifying Party in connection with conducting the defense and handling of such Claim and defend or handle such Claim in such manner as it may deem appropriate. In such event, the Indemnified Party shall keep the Indemnifying Party timely apprised of the status of such Claim and shall not settle such Claim without the prior written consent of the Indemnifying Party, which consent shall not be unreasonably withheld. If the Indemnified Party defends or handles such Claim, the Indemnifying Party shall cooperate with the Indemnified Party, at the Indemnified Party’s request but at no expense to the Indemnified Party, and shall be entitled to participate in the defense and handling of such Claim with its own counsel and at its own expense.

13.4 Mitigation of Loss. Each Indemnified Party will take and will procure that its Affiliates take all such reasonable steps and action as are necessary or as the Indemnifying Party may reasonably require in order to mitigate any Claims (or potential losses or damages) under this Article 13. Nothing in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.

13.5 Special, Indirect and Other Losses. NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY, EXCEPT TO THE EXTENT ANY SUCH DAMAGES ARE REQUIRED TO BE PAID TO A THIRD PARTY AS PART OF A CLAIM FOR WHICH A PARTY PROVIDES INDEMNIFICATION UNDER THIS ARTICLE 13.

13.6 No Exclusion. Neither Party excludes any liability for death or personal injury caused by its negligence or that of its employees, agents or subcontractors.

14. GENERAL PROVISIONS

14.1 Assignment. Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent, except that:

(a) either Party may assign its rights and obligations under this Agreement or any part hereof to one or more of its Affiliates without the consent of the other Party, so long as such Affiliate is and remains an Affiliate. If the assignee ceases to be an Affiliate of the assigning Party for any reason the assignee will reassign this Agreement to GW or Novartis, as applicable, upon ceasing to be an Affiliate; and

(b) either Party may assign this Agreement in its entirety to an acquirer of all or substantially all of its business or assets to which this Agreement relates (meaning: (i) with respect to Novartis, that this Agreement may only be assigned together with the personnel and infrastructure previously engaged directly in the Commercialization and filing for Regulatory Approval of Products in the Territory; and (ii) with respect to GW, that this Agreement may only be assigned together with both the GW Technology and GW Trademarks, all Product related license and/or collaboration agreements with licensees of the Products outside the Territory, and the personnel and infrastructure engaged directly in the Development and manufacture of the Products, and filing for Regulatory Approval of Products in the EU at the

time of the assignment and on the condition that, at the time of the assignment, GW puts in place appropriate arrangements with any key personnel previously engaged directly in the Development and manufacture of the Products who are not being acquired by the Third Party to allow GW and Novartis to continue to access the Product related Know How and knowledge held by these persons; and

(c) GW may assign this Agreement by way of security only when both (i) such security interest covers all of GW’s assets to which this Agreement relates (meaning that this Agreement may only be assigned by way of security where such security interest also covers the GW Technology, GW Trademarks, all Product related license and/or collaboration agreements with licensees of the Products outside the Territory, and the infrastructure engaged directly in the manufacture of the Products); and (ii) the assignee/security holder agrees that, in the event that it forecloses on, or otherwise exercises its security interest with respect to, any of the assets to which this Agreement relates, it will pending repayment of the sums due to the assignee/security holder use reasonable endeavours to ensure continuity of supply of the Product to Novartis;

and the assigning Party will provide the other Party with prompt written notice of any such assignment. Any permitted assignee will assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment). Any attempted assignment in contravention of the foregoing will be void. Subject to the terms of this Agreement, this Agreement will be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.

14.2 Severability. Should one or more of the provisions of this Agreement become void or unenforceable as a matter of law, then this Agreement will be construed as if such provision were not contained herein and the remainder of this Agreement will remain in full force and effect. The Parties will use their commercially reasonable efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.

14.3 Governing Law and Jurisdiction. This Agreement will be governed by and construed under the laws in effect in the State of New York, without giving effect to the conflicts of laws provision thereof. The United Nations Convention on Contracts for the International Sale of Goods (1980) will not apply to the interpretation of this Agreement.

14.4 Dispute Resolution.

(a) In the event of a dispute under this Agreement, the Parties will refer the dispute to the Alliance Managers for discussion and resolution. If the Alliance Managers are unable to resolve any such dispute within thirty (30) days of the dispute being referred to them, either Party may require that the Parties forward the matter to the Senior Officers (or designees with similar authority to resolve such dispute), who shall attempt in good faith to resolve such dispute. If the Senior Officers cannot resolve such dispute within thirty (30) days of the matter being referred to them, either Party shall be free to initiate the arbitration proceedings outlined in sub-Section (b) below.

(b) Any unresolved disputes between the Parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance by either Party of its obligations hereunder, whether before or after termination of this Agreement, shall be resolved by final and binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. Arbitration shall be held in New York, New York, USA, according to the commercial rules of the International Chamber of Commerce ( “ICC” ). The arbitration will be conducted by a

panel of three arbitrators appointed in accordance with ICC rules; provided that each Party shall, within thirty (30) days after the institution of the arbitration proceedings, appoint an arbitrator, and such arbitrators shall together, within thirty (30) days, select a third arbitrator as the chairman of the arbitration panel. Each arbitrator shall have significant experience in the pharmaceutical business. If the two initial arbitrators are unable to select a third arbitrator within such thirty (30) day period, the third arbitrator shall be appointed in accordance with ICC rules. Discovery shall be subject to all applicable privileges and other immunities under the U.S. Federal Rules of Civil Procedure and shall be limited to: (i) the production of documents available in the ordinary course of business in accordance with the producing Party’s standard document retention policies within specified relevant categories from no more than ten (10) individual representatives of the producing Party who have been identified by the other Party in its document request; (ii) two (2) depositions per side; and (iii) ten (10) interrogatories per side. The Parties shall request that the arbitrators render their opinion within thirty (30) days of the final arbitration hearing. No arbitrator (nor the panel of arbitrators) shall have the power to award punitive damages under this Agreement and such award is expressly prohibited. Decisions of the panel of arbitrators shall be final and binding on the Parties. Judgment on the award so rendered may be entered in any court of competent jurisdiction. The losing Party to the arbitration (if any) as determined by the arbitrators shall pay the costs of the arbitration.

14.5 Force Majeure. In the event that either Party is prevented from performing its obligations under this Agreement (other than the obligations to make any payments or of confidentiality) as a result of any contingency beyond its reasonable control that could not have been avoided by due care being taken by such non-performing Party ( “Force Majeure” ), including any actions of governmental authorities or agencies, war, hostilities between nations, civil commotions, riots, national industry strikes, lockouts, sabotage, shortages in supplies, energy shortages, fire, floods and acts of nature such as typhoons, hurricanes, earthquakes, or tsunamis, the Party so affected will not be responsible to the other Party for any delay or failure of performance of its obligations hereunder, for so long as Force Majeure prevents such performance. In the event of Force Majeure, the Party immediately affected thereby will give prompt written notice to the other Party specifying the Force Majeure event complained of, and will use commercially reasonable efforts to resume performance of its obligations. Notwithstanding the foregoing, if such a Force Majeure induced delay or failure of performance continues for a period of more than three (3) consecutive months, either Party may terminate this Agreement upon written notice to the other Party with the consequences of termination being: (i) as set out in Section 11.1 if GW is the terminating Party; and (ii) as set out in Section 11.2 if Novartis is the terminating Party.

14.6 Waivers and Amendments. The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver will be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

14.7 Relationship of the Parties. Nothing contained in this Agreement will be deemed to constitute a partnership, joint venture, or legal entity of any type between Novartis and GW, or constitute one as the agent of the other. Moreover, each Party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. each Party will act solely as an independent contractor, and nothing in this Agreement will be construed to give any Party the power or authority to act for, bind, or commit the other.

14.8 Notices. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (a) delivered by hand (with written

confirmation of receipt); or (b) sent by facsimile (with provision for assurance of receipt in a manner typical with respect to communications of that type); or (c) when received by the addressee, if sent by an internationally recognized overnight delivery service, in each case to the appropriate addresses set forth below (or to such other addresses as a Party may designate by written notice):

If to GW:

GW Pharma Limited

Porton Down Science Park

Salisbury,

Wiltshire

SP4 OJQ

United Kingdom

Attention: Managing Director

Fax number: +44 1980 557111

If to Novartis:

Novartis Pharma AG

P.O. Box

CH - 4002 Basel

Switzerland

Attn: Head, Business Development and Licensing

Fax: +41-61-324-2511

with a copy to:

Novartis Pharma AG

P.O. Box

CH - 4002 Basel

Switzerland

Attn: Head, Legal Department

Fax: +41-61-324-7399.

14.9 Further Assurances. GW and Novartis hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as may be reasonably necessary to carry out the intent and purposes of this Agreement.

14.10 Compliance with Law. Each Party will perform its obligations under this Agreement in accordance with all applicable Laws. No Party will, or will be required to, undertake any activity under or in connection with this Agreement which violates, or which it believes, in good faith, may violate, any applicable law.

14.11 No Third Party Beneficiary Rights. The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they will not be construed as conferring any rights to any Third Party (including any third party beneficiary rights).

14.12 English Language. This Agreement is written and executed in the English language. Any translation into any other language will not be an official version of this Agreement and is solely for reference. In the event of any conflict in interpretation between the English version and such translation, the English version will prevail.

14.13 Expenses. Except as otherwise expressly provided in this Agreement, each Party will pay the fees and expenses of its respective lawyers and other advisors and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution and delivery of this Agreement.

14.14 Entire Agreement. This Agreement, together with its Exhibits, and the Manufacturing and Supply Agreement sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter. In the event of any conflict between a substantive provision of this Agreement and any Exhibit hereto, the substantive provisions of this Agreement will prevail. In the event of any conflict between a substantive provision of this Agreement and a substantive provision the Manufacturing and Supply Agreement, the substantive provisions of the Manufacturing and Supply Agreement will prevail with respect to any issues relating to Product manufacture and supply (including the price and payment terms) and the substantive provisions of this Agreement will prevail with respect to any other term.

14.15 Counterparts. This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

14.16 Foreign Corrupt Practices Act/Bribery Act. Each Party hereby covenants and agrees that in connection with the Agreement, neither it nor any of its representatives, agents or Affiliates will make, promise or authorize, directly or indirectly, any payment or any gift or anything of value to any government officials, political candidates, political party or customer representatives (except such payments as are required by law and made to such officials or representatives in other than their individual capacities) which would constitute a violation of the U.S. Foreign Corrupt Practice Act of 1977, as amended, and the rules and regulations thereunder, the UK Bribery Act of 2010, as amended, and the rules and regulations thereunder or any other applicable anti-bribery or anti-corruption laws of any country or take any other action that would constitute a violation of any such laws.

14.17 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each will be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

[ Signature Page Follows. ]

IN WITNESS WHEREOF, the Parties intending to be bound have caused this Agreement to be executed by their duly authorized representatives.

GW PHARMA LTD		NOVARTIS PHARMA AG


By:	/s/ Justin Gover	By:	/s/ ***

Name:	Justin Gover	Name:	***

Title:	Managing Director	Title:	Novartis Pharma AG, Head Partnering &
			Emerging Businesses Forum 2.6.04
Date:	13/4/2011		4002 Basel

		Date:	8/4/2011


		By:	/s/ ***

		Name:	***

		Title:	Senior Legal Counsel

		Date:	8/4/2011

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EXHIBIT A

GW PATENTS AND GW TRADEMARKS

GW Patents

Invention

Country

Client Ref.

Application No.

Application Date

Grant No.

Grant Date

Status

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

GW Trademarks

Trade Mark

Applicant

Country

Application No.

Application
Date

Registration
No.

Registration
Date

Status

Classes

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

License, assignment, distribution or other agreements relating to the GW Patents and GW Know-How in the Territory and all license, assignment, distribution, co-existence, prior rights or other agreements relating to the GW Trademarks in the Territory

Patent agreement between *** dated 25 August 2001, under which all rights in the GW Patent Rights in patent family P0002 were assigned to GW.

Co-existence agreement between Novartis AG and GW Pharma Ltd relating to the *** and *** trademarks dated 15 January 2007.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EXHIBIT B

Sativex

Pharmaceutical Form

Oromucosal spray solution

Qualitative and Quantitative Composition

The solution contains:

THC BDS 27mg/ml and CBD BDS 25mg/m1

Excipients:

1. Ethanol anhydrous

2. Propylene glycol

3. Peppermint oil

EXHIBIT C

Territory

Australia

Fiji

New Zealand

Part A — Africa Region

Algeria

Angola

Benin

Botswana

Burkina Faso

Burundi

Cameroon

Cape Verde

Central African Republic

Chad

Comoros

Congo, Democratic Republic Of The

Congo, Republic Of The

Cote D’lvoire

Djibouti

Egypt

Equatorial Guinea

Eritrea

Ethiopia

Gabon

Gambia, The

Ghana

Guinea

Guinea-Bissau

Kenya

Lesotho

Liberia

Libya

Madagascar

Malawi

Mali

Mauritania

Mauritius

Mayottte

Morocco

Mozambique

Namibia

Niger

Nigeria

Rwanda

Saint Helena, Ascension & Tristan Da Cunha

Sao Tome & Principe

Senegal

Seychelles

Sierra Leone

Somalia

South Africa

Sudan

Swaziland

Tanzania

Togo

Tunisia Uganda

Western Sahara

Zambia Zimbabwe

Part B — Asia Region

Afghanistan

Bangladesh

Bhutan

British Indian Ocean Territory

Brunei

Burma

Cambodia

India

Indonesia

Korea, North

Korea, South

Laos

Malaysia

Maldives

Nepal

Pakistan

Papua New Guinea

Paracel Islands

Phillippines

Singapore

Spratly Islands

Sri Lanka

Taiwan

Thailand

Timor-Leste

Vietnam

Part C — Middle East Region

Armenia

Azerbaijan

Bahrain

Belarus

Georgia

Kazakhstan

Kryrgyzstan

Iran

Iraq

Jordan

Kuwait

Lebanon

Oman

Mongolia

Qatar

Saudi Arabia

Syria

Tajikistan

United Arab Emirates

Turkmenistan

Uzbekistan

Yemen

EXHIBIT D

LATAM Region

Central America

Anguilla

Antigua & Barbuda

Aruba

Bahamas, The

Barbados

Belize

British Virgin Islands

Cayman Islands

Costa Rica

Cuba

Curacao

Dominica

Dominican Republic

El Salvador

Grenada

Guatemala

Haiti

Honduras

Jamaica

Montserrat

Navassa Island

Nicaragua

Panama

Saint Barthlemy

Saint Kitss & Nevis

Saint Lucia

Saint Martin

Saint Vincent & The Grenadines

Saint Maarten

Trinidad & Tobago

Turks & Caicos Islands

South America

Argentina

Bolivia

Brazil

Chile

Colombia

Ecuador

Falkland Islands (Islas Malvinas)

French Guiana (France)

Guyana

Paraguay

Peru

S. Georgia & S. Sandwich Islands

Suriname

Uruguay

Venezuela

North America

Bermuda

Mexico

EXHIBIT E

Form of Invoice

Sender’s Logo		INVOICE
		INVOICE DATE:
Street		20
Town,Country		INVOICE NO.: XXXX
Phone and Fax Nr.

Bill To:		For:
[ ]		Product X Royalties 1 st Quarter 2006
		(or Milestone for event Y)

And via fax to no. [ ]

DESCRIPTION [Please specify the event for which the invoice is due]	AMOUNT (USD)
Product X royalties January — March 20 calculated based on Novartis provided sales & royalty report (see attached worksheet)	US$		000,000.00

(Or milestone payment for event Y, according to paragraph XY of agreement ZZZZ dated )

Novartis Contract Code

Please remit by wire transfer within 60 days to:
Receiving Bank -
Swift Code -
ABA Number -
Credit Account -
Beneficiary -
TOTAL	US$	000,000.00

If you have any questions concerning this invoice, contact
or e-mail to
VAT -Reg. No. Xxxxxxxxxx (if applicable)

EXHIBIT F

Key Manufacturing and Supply Terms

Key definitions

“Additional Services” shall mean the packaging and labelling of Sativex BDP to produce Finished Product in a presentation ready for sale in a particular country or group of countries in the Territory.

“Direct Manufacturing Costs” shall mean costs incurred by GW in the actual manufacturing of Sativex BDP, established on a regular, standard basis in accordance with Accounting Standards as consistently applied by GW, expressed on a per unit basis. Direct Manufacturing Cost shall be calculated according to the principles of “open book” and include the following elements:

(i) ***

;

(ii) ***

(iii) ***

; and

(iv) ***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“Finished Product” shall mean Sativex BDP, packaged and labelled and ready for Commercialization in the Territory.

“Process” and “Processing” shall mean any and all operations, including packaging for shipment, carried out by or on behalf of GW in the preparation, testing and release of the Sativex BDP.

“Sativex BDP” shall mean fully formulated, vialed Sativex product comprised of BDS and excipients filled into nude (unlabelled) 10m1 vials ready to be packaged and labelled, as further described in Exhibit B to the Distribution and License Agreement.

1. Duration

1.1 The term of the Distribution and License Agreement, subject to early termination for unremedied material breach or insolvency.

2. Forecasting and ordering

2.1 Sativex BDP will be ordered by Novartis against a rolling forecast, with details of firm order periods and other related matters to be contained in the Manufacturing and Supply Agreement.

2.2 In addition, Novartis will have the ability to request GW to provide Additional Services from time to time. The fee for providing Additional Services will be agreed on a case by case basis.

3. GW’s Responsibilities

3.1 To establish capacity to Process sufficient Sativex BDP so as to meet Novartis’s requirements for the Territory.

3.2 To have obtained and maintained such approvals as may be required to operate the necessary manufacturing facilities for the purpose of the manufacture of batches of Product in accordance with applicable Laws and regulatory requirements.

3.3 A quality agreement will be executed along with the Manufacturing and Supply Agreement.

4. Delivery :

4.1 GW shall Deliver the Product FCA Kent Science Park or such other location as agreed from time to time. Novartis will bear export duties and taxes.

5. Warranties

5.1 GW to represent and warrant that (i) it shall manufacture, store and deliver the Product in compliance with applicable GMPs, applicable Laws, the quality agreement, and master batch records and/or any other procedures agreed upon by the Parties in writing, (ii) at the time of delivery, the Product will conform to the Specifications.

6. Price

6.1 Price.

(a) ***

(b) ***:

(i) ***; and

(ii) ***.

(d) ***:

(i) ***; and

(ii) ***,

***.

(e) ***

(f) ***.

6.2 ***.

(b) ***.

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX 1

Inflation Adjustment of the Direct Manufacturing Cost Cap

	Inflation (initial baseline at Effective Date set to 100%)	Yearly inflation by end of year	New baseline set to 100% as soon 2% cap as been reached	Coverage by GW	Coverage by Novartis
Year 1
Year 2
Year 3
Year 4
Year 5
Year 6
Year 7
Year 8
Year 9
Year 10
Year 11

Note: Figures in table are illustrative only

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX 2

***

	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***
***	***	***	***	***	***

***:

***

Figures in table are illustrative only and stated in US dollars. Actual figures will be stated in UK Pounds.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.23

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

MANUFACTURING AND SUPPLY AGREEMENT

effective as of this 9 day of November, 2011 (the “ Effective Date ”),

by and between

NOVARTIS PHARMA AG

Lichtstr. 35

CH-4056 Basel

Switzerland

(hereinafter “ NOVARTIS ”)

and

GW Pharma Ltd

Porton Down Science Park

Wiltshire SP4 03Q

United Kingdom

(hereinafter “ GW ”)

Signature version

WHEREAS, NOVARTIS is engaged in the manufacture, marketing and sales of pharmaceutical products;

WHEREAS , GW is a company engaged in the processing and supply of pharmaceutical products holding the necessary manufacturing licenses and permits in this respect ;

WHEREAS , NOVARTIS and GW have entered into a Distribution and License Agreement dated 8 April 2011 (the “Distribution and License Agreement”) whereby GW has appointed NOVARTIS to, distribute and sell certain products in the Territory, as defined therein;

WHEREAS , NOVARTIS requires GW to perform certain services related to the Processing and supply of the Product (each as defined herein) pursuant to the Specifications and the terms and conditions of this Agreement and requires the right to request that GW perform certain additional packaging and labelling services.

NOW, THEREFORE, in consideration of the foregoing premises and the following mutual covenants and for other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereto agree as follows:

1. Definitions

1.1 Defined Terms

In this Agreement capitalized words and phrases shall have the same meaning as in the Distribution and License Agreement, save that the following terms shall, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:

“ Acknowledgement ” shall have the meaning given to it in Clause 5.5 .

“ Additional Services ” shall mean the Packaging and Labelling of Product to produce Finished Product in a Presentation ready for sale in a particular country or group of countries in the Territory and the testing and release of the Finished Product.

“ Adverse Event ” shall mean any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse effect can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

“ Approved Subcontractor(s) ” shall mean (i) any Affiliates of GW and/or other Third Parties subcontracted by GW prior to the date hereof to perform part of GW’s Processing obligations hereunder, as listed in the QA Agreement and (ii) any Affiliates of GW and/or other Third Parties contracted by GW after the date hereof, after prior discussion with NOVARTIS through the Alliance Managers, to perform part of its obligations hereunder.

“ Batch ” shall mean batches of vials of the Product in the sizes set forth in Annex 1 .

“ Business Continuity Plan ” shall mean a plan clearly defining and documenting a set of measures designed to (i) allow a quick response to a disruptive event so that the business process is restored to a minimum required operational level and/or (ii) recover the business process in a defined time frame; such plan shall cover in particular all key personnel, resources, services and actions which are required to manage the business continuity management process.

“ Change ” shall have the meaning given to it in Clause 10.1 .

“ Components ” shall mean, collectively, the excipients and materials required to Process and package a shipment of the Product in accordance with the Specifications, as set forth in Annex 6 . For clarity, BDS is not a Component.

“ Confirmed Delivery Date ” shall mean the date for Delivery of a quantity of the Product as set forth in the relevant Acknowledgement or such other date as may be mutually agreed by the Parties in writing pursuant to Clause 5.5 .

“ Contract Year ” shall mean a twelve (12) month period beginning January 1st, of each calendar year. With exception to the foregoing, the first Contract Year of this Agreement shall commence on the Effective Date and shall expire on December 31st 2011.

“ Defective Product ” shall mean Product that does not comply with the Product Warranties at the time of Delivery.

“ Deliver ” or “ Delivery ” shall mean the despatch of the Product by GW pursuant to Clause 7.1 .

“ Delivery Date ” shall mean the requested date for Delivery of a quantity of the Product as set forth in the relevant Firm Order.

“ Direct Manufacturing Costs ” shall have the meaning attributed in Annex 1 below.

“ Direct Manufacturing Cost Cap ” shall have the meaning attributed thereto in Clause 8.1(b) below.

“ Facility(-ies) ” shall mean GW’s (or its Approved Subcontractor’s) Processing facility(-ies), located at:

***

“ Finished Product ” means the Product Packaged and Labelled and ready for Commercialization in the Territory.

“ Firm Order ” shall have the meaning attributed thereto in Clause 5.3 below.

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“ Forecast ” shall have the meaning attributed thereto in Clause 5.1 below.

“ Good Manufacturing Practice ” or “ GMP ” shall mean all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products in the EU, including Directive 2003/94/EC and the principles detailed in the ICH Q7A guidelines, each as may be applicable and as amended from time to time.

“ Inflation Adjustment ” shall have the meaning attributed thereto in Clause 8.1(d) .

“ Inflation Cap ” shall have the meaning attributed thereto in Clause 8.1(e) .

“ Initial Period ” shall mean (i) for the purposes of Clauses 5.4 and 15.2, the period of twelve (12) months following Delivery of the first Batch to NOVARTIS, and (ii) for the purposes of the “Batch” sizes in Annex 1 , the period of twenty four (24) months following Delivery of the first Batch to Novartis.

“ KPI ” shall mean the key performance indicators to be set forth in the Trading Services Procedures to be agreed by the Parties pursuant to Clause 7.4 , against which the performance by GW under this Agreement will be measured and monitored.

“ Label ”, “ Labelled ” or “ Labelling ” shall mean all labels and other written, printed or graphic matter upon (i) a product or any container or wrapper utilised with a product; or (ii) any written material accompanying a product, including, without limitation, package inserts and patient information leaflet.

“ Master Batch Records ” shall mean the record determining the Process by which a Batch is manufactured, as required under GMP.

“ Packaged ” shall mean product boxed in all necessary Packaging Materials and “ Packaging ” shall mean the activity of boxing product in all necessary Packaging Materials.

“ Packaging Materials ” shall mean all materials employed in the packaging of a product, excluding any outer packaging used for transportation or shipment. Packaging Materials are referred to as primary or secondary packaging materials according to whether or not they are intended to be in direct contact with the medicinal product and as bulk packaging materials.

“ Pharmacovigilance Agreement ” shall mean the pharmacovigilance agreement to be entered into by the Parties with respect to the Product, the agreed form of which is attached hereto at Exhibit A .

“ Presentation ” shall mean Finished Product Packaged and Labelled for Commercialization in a particular country or group of countries in the Territory.

“ Price ” shall mean the price per vial of the Product, as set forth in Clause 8.1 .

“ Process ” and “ Processing ” shall mean any and all operations, including packaging for shipment, carried out by or on behalf of GW in the preparation, testing, quality control and release of the Product under this Agreement.

“ Product ” shall mean Sativex® BDP filled into 10ml vials ready to be Packaged and Labelled by NOVARTIS.

“ Product Warranties ” shall have the meaning attributed thereto in Clause 2.2

“ Quality Assurance ” or “ QA ” shall be the sum total of the organized quality assurance arrangements made with the purpose of ensuring that the Product meets the Specifications and is of the quality required for its intended use and shall specifically include all activities as set forth in the QA Agreement to be executed by the Parties. The agreed form QA Agreement is attached hereto as Exhibit B .

“ Registration ” shall mean any and all governmental approvals necessary and/or required to be granted by a Regulatory Authority for the Processing of Product.

“ Sativex BDP ” shall mean fully formulated, vialled Sativex® product comprised of BDS and Components filled into nude (unlabelled) 10ml vials, as further described in Exhibit B to the Distribution and License Agreement.

“ Specifications ” shall mean the specifications for the BDS, Components and/or the Product (as the case may be) as set forth in the QA Agreement, which may be amended only via the Change procedure.

“ Validation ” shall mean the completion of at least three (3) qualification batches for the Product which meet predetermined validation acceptance criteria, as well as the normal product release criteria and stability requirements set forth in the specifications therefor, all as set forth in a written validation plan.

“ Visual Inspection ” shall mean:

(a) comparing the applicable Acknowledgement against the documentation accompanying the Delivery to verify that the identity, quantity and exterior shipment Packaging and Labelling comply with the Acknowledgement;

(b) verifying that the certificate(s) of analysis for the Delivery states that the Product conforms in all material respects to the Specifications; and

(c) visually inspecting the exterior of the quantity of Product Delivered to verify that the Delivery appears to be in good condition.

1.2 Currency

Unless otherwise indicated, all monetary amounts are expressed in this Agreement in Sterling Pounds (“GBP”), the lawful currency of Great Britain.

1.3 Exchange Rates

With respect to amounts invoiced in a currency other than GBP, all such amounts shall be expressed both in the currency in which the amount was invoiced and in the GBP equivalent. The GBP equivalent shall be calculated using GW’s then-current standard exchange rate methodology applied in its

external reporting which is ultimately based on official rates such as Reuters and the European Central Bank.

1.4 Clauses and Headings

The division of this Agreement into clauses, subclauses and Annexes and the insertion of headings are for convenience of reference only and shall not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a clause or an annex refers to the specified Clause or ANNEX to this Agreement. In this Agreement, the terms “this Agreement”, “hereof”, “herein”, “hereunder” and similar expressions refer to this Agreement.

1.5 Singular Terms

Except as otherwise expressly provided herein or unless the context otherwise requires, all references to the singular shall include the plural and vice versa.

1.6 Day

Any reference herein to a “day” (including “week”) shall be references to a Business Day.

1.7 Annexes and Exhibits

The following Annexes and Exhibits shall be attached to, incorporated in and form part of this Agreement:

ANNEX 1 Product and Pricing

ANNE X 2 NOVARTIS HSE Policy

ANNEX 3 NOVARTIS Policy Statement

ANNEX 4 Inflation Adjustment of the Direct Manufacturing Cost Cap

ANNEX 5 Cost Improvement Benefit Sharing

ANNEX 6 Components

EXHIBIT A Agreed form Pharmacovigilance Agreement

EXHIBIT B Agreed form QA Agreement

EXHIBIT C Standard form Trading Services Procedure

2. Scope of the Agreement

2.1 Continuous Supply . GW agrees to act in good faith in performing its obligations under this Agreement and shall not wilfully delay production nor wilfully withhold Delivery of the Product.

2.2 Supplier Warranty . GW represents and warrants that (i) it shall Process, store and Deliver Product in material compliance with applicable GMPs, applicable Laws, the QA Agreement, and Master Batch Records and/or any other procedures agreed upon by the Parties in writing, and (ii) at the time of Delivery, Product will conform to the Specifications (the “ Product Warranties ”).

2.3 Compliance with Policies . GW agrees to abide by the NOVARTIS HSE Policy and NOVARTIS Policy Statement, respectively set forth in Annex 2 and Annex 3 hereof.

2.4 Approved Subcontractors .

(a) The Processing activities set forth in Annex E to the QA Agreement are currently subcontracted to the subcontractors noted on such Annex. NOVARTIS hereby consents to subcontractors listed in Annex E to the QA Agreement continuing to provide the Processing related services setout therein following the date of this Agreement. GW shall not subcontract any additional Processing work to any Person or change the current subcontractor performing any activity the subject of the first sentence of this Clause 2.4 without NOVARTIS’ prior written approval, such consent not to be unreasonably withheld, delayed or conditioned. NOVARTIS will be unreasonably withholding its consent to a proposed subcontractor if such subcontractor complies with GMP and all applicable Laws unless NOVARTIS can produce

evidence in the form of written documents which demonstrate that use of the proposed subcontractor to provide Processing related services will likely affect the supply of the relevant Product to NOVARTIS. GW shall give NOVARTIS written notice of the identity of any additional subcontractor it wishes to engage to provide Processing related services and the Processing related services such Person will be performing. If GW has not received notice from NOVARTIS objecting to a proposed subcontractor within 30 days of submitting the notice specified above NOVARTIS shall be deemed to have consented to the appointment of the proposed subcontractor to provide the Processing- related services specified in GW’s notice and thereafter such Person shall be an Approved Subcontractor. In case of the appointment/change in GW’s subcontractors involved in Processing, the requirements of Clause 10 shall be observed.

(b) GW shall ensure that any agreement entered into or amended after the Effective Date with any Approved Subcontractor shall contain terms and provisions which ensure such subcontractor’s compliance with terms consistent with the relevant requirements of this Agreement and of the QA Agreement. GW shall remain responsible and liable to NOVARTIS for any acts or omissions of any Approved Subcontractor as if such acts or omissions were committed by GW.

2.5 Facility . GW will Process the Product exclusively at the Facility(ies). Transfer of the Processing of the Product or any part thereof to another facility will occur according to the process set forth in Clauses 3.2 and 10, and Clause 2.4 if being transferred to an Approved Subcontractor.

2.6 Affiliates . GW agrees that Novartis Pharma Stein AG may order Product directly from GW in accordance with terms and conditions of this Agreement and may request that Products be delivered directly to Novartis Pharma Stein AG, together with the appropriate invoice. NOVARTIS shall remain responsible and liable to GW for payment of any and all invoices submitted to Novartis Pharma Stein AG.

2.7 Authorizations and Permits . GW warrants that it and/or its Approved Subcontractors hold all necessary Registrations for the country or countries where such Processing takes place at the Effective Date. GW covenants to continue to hold and/or ensure its Approved Subcontractors continue to hold all necessary Registration for the country or countries where Processing takes place after the Effective Date. GW shall provide copies of any such Registrations to NOVARTIS upon NOVARTIS’ request. Without prejudice to any of NOVARTIS’ other rights under this Agreement, GW shall inform NOVARTIS promptly in writing in the event any such Registration is not obtained or is withdrawn or otherwise under investigation.

3. Validation / Launch Preparation / Capacities

3.1 Ready to Supply . As at the date hereof each Facility is Validated and GW is ready to supply NOVARTIS with the Product.

3.2 Validation of changes to Facility . GW undertakes to successfully qualify and Validate any Change to Processing at an existing Facility and Processing at a new facility. GW shall notify NOVARTIS once a Change or a new facility has been Validated. Subject to Clause 10 , once a new facility has been Validated and is in receipt of all necessary Registrations it shall become a Facility.

3.3 Prioritization . In the event that GW does not have available sufficient Processing capacities to satisfy the requirements of all its customers for Product, NOVARTIS shall be supplied with a pro rated amount of Product from GW’s available supply such that NOVARTIS receives at least the same percentage of its affected Firm Orders as all other affected customers of GW.

4. Components

4.1 Procurement of Components . GW shall (or shall cause its Approved Subcontractors), at GW’s cost, to purchase, qualify, test, inspect and approve all Components required for Processing.

4.2 Stock of Components . GW shall ensure that: (a) its stock of BDS and Components is always sufficient to permit the uninterrupted Processing of Product in full compliance with NOVARTIS’ Firm Orders; (b) the quantities of BDS and/or Components ordered and stored by it relate appropriately to NOVARTIS’ Firm Orders so that the items in stock do not become obsolete or unsellable; and (c) the Components are of suitable quality as required under the Specifications.

4.3 Safety Stocks of Components . In addition to Clause 4.2 , during the term of this Agreement, GW will maintain and continually replenish (based on first-in, first-out (“ FIFO ”) and first-expiry, first out (“ FEFO ”) methods of usage) a rolling safety stock of BDS and Components of sufficient size so that Deliveries up to *** percent (***%) of the semi-binding portion of the then current Forecast can be Delivered. GW will notify NOVARTIS in writing if it is forced to Process any or all of the safety stock. In the event that GW is forced to Process the safety stocks in order to meet NOVARTIS’ Firm Orders in circumstances where GW cannot replenish these safety stocks immediately for whatever reason, such failure to replenish the safety stock shall not constitute a breach of this Clause 4.3 by GW provided that GW shall, subject to the following sentence of this Clause 4.3 replenish the safety stocks as soon as practicable but in any event within six (6) months of GW being forced to Process such safety stocks. If it is not practicable for GW to replenish all of the safety stocks within six (6) months of their use (as a direct result of ordering lead time, growing cycle, processing time) the Parties will meet in good faith to discuss and agree a schedule for replenishing the safety stocks. GW will wind down its safety stock inventory prior to the expiration of this Agreement.

5. Forecasting / Ordering Procedures

5.1 Forecasts . No later than six (6) months prior to the anticipated first Delivery Date and by the first day of each month thereafter, NOVARTIS shall prepare

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and provide GW with a written forecast of its requirement for the Product for the Territory, by months, for at least the following eighteen (18) months (“ Forecast ”). In determining Forecast quantities NOVARTIS shall take account of Batch sizes.

5.2 Liaison . GW agrees to discuss (via conference call) with NOVARTIS on a monthly basis the latest Forecast sent by NOVARTIS. The purpose of this discussion is for NOVARTIS to explain changes made to the previous Forecast and to highlight any foreseeable developments in Commercialization of the Product in the Territory that may affect future Forecasts and otherwise to discuss demand and GW’s capacity to meet NOVARTIS’ Forecast.

5.3 Firm Orders . NOVARTIS shall have a binding commitment to place orders for and purchase from GW the quantity of the Product detailed in the first three (3) months of each Forecast on the terms and conditions of this Agreement. NOVARTIS shall issue to GW a formal purchase order for the quantity of the Product in the first month of each Forecast (“ Firm Order ”) by no later than the fifth day of such month and with a lead time to Delivery of at least 90 days. In determining Firm Order quantities, NOVARTIS shall take account of the Batch sizes, such that GW shall have no obligation to supply quantities of the Product in the event NOVARTIS places a Firm Orders for amounts of the Product that are not multiples of GW’s Batch size and NOVARTIS must accept as fulfilled orders actual quantities of the Product Delivered which are within a margin of *** percent (+***%) and *** percent (-***%) of the quantity confirmed in the Acknowledgement.

5.4 Semi-Firm Order Periods The amounts set forth in months four to eighteen of a Forecast shall constitute NOVARTIS’ non-binding, good faith estimate of NOVARTIS’ requirements for the Product for such periods; provided, however, that following the Initial Period the quantity set forth in month five of a Forecast, when such month becomes month three of a subsequent Forecast, shall not be less than *** per cent (***%) nor shall GW be obligated to supply greater than *** per cent (***%) of the amounts set forth in the

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Forecast where the month in question was month five in a previous Forecast. For clarity where following the Initial Period, in a particular Forecast, the volume of Product specified in month five is less than ***, when such month becomes months three of a subsequent Forecast NOVARTIS may increase/decrease the number of Batches in that month three by +/- one (1) Batch from the amount indicated in month five (5) of the relevant previous Forecast without being in breach of this Clause 5.4 .

5.5 Acknowledgments . GW shall respond to each Firm Order received from NOVARTIS within five (5) days of receipt. The response shall include confirmation of GW’s ability to supply the quantity of vials of the Product set out in the Firm Order (less any amount required to be retained by Law, the QA Agreement or to complete stability testing) and the date(s) by which GW will be able to Deliver the vials ordered each an “ Acknowledgment ”). In the event that discussion is required regarding the timing of Delivery then the relevant personnel from both Parties will negotiate in good faith and agree and confirm in writing an amended Firm Order within four (4) days of receipt by GW of the original Firm Order. For clarity, GW shall not be entitled to reject any Firm Order if (i) the volumes of Product ordered therein are consistent with the latest Forecast and (ii) the Firm Order is for a multiple of the then applicable Batch size.

5.6 Increased Orders. Should any Firm Order for a month include volumes of vials of the Product in amounts that exceed the amounts set forth in the most recent Forecast for that month provided by NOVARTIS to GW pursuant to Clause 5.1 , or should NOVARTIS desire to increase the amount of the Product to be Processed pursuant to any already submitted Firm Order, then GW shall use commercially reasonable efforts to comply with such requested changes. Notwithstanding the foregoing, GW shall not be liable to NOVARTIS for any inability, despite using its commercially reasonable efforts, to Process such excess Product.

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6. Additional Services

6.1 From time to time NOVARTIS shall have the right to request GW provide Additional Services. Each request for Additional Services shall specify:

(a) the Presentation in which Finished Product is to be supplied;

(b) the Specifications for the Finished Product and any other special instructions; and

6.2 Following receipt of such a request, the Parties shall, in good faith, negotiate the terms on which GW shall supply the Additional Services in question.

7. Delivery

7.1 Terms of Delivery . GW shall Deliver the Product FCA (as such term is defined in INCOTERMS 2000) *** or such other location as agreed from time to time. NOVARTIS will bear all export duties and taxes. Subject to Clause 5.3 , GW shall not be entitled to Deliver partial shipments of the Product unless expressly authorized by NOVARTIS in writing to do so.

7.2 Packaging . Packaging for transport conditions shall be based upon the Specifications for the transportation of the Product. GW shall Package Product for Delivery in standard Packaging Materials for transport by road in a refrigerated vehicle. NOVARTIS shall be responsible for Packaging Product in any additional Packaging required to transport Product by some different transportation means. GW shall facilitate the orderly Delivery and taking over by the selected carrier of any Product Delivered to NOVARTIS.

7.3 Shelf Life . Upon Delivery, the Product’s residual shelf life must be at least *** percent (***%) of the Product’s total shelf life (as specified in the QA Agreement). The Delivery of Product with less than the required residual shelf life pursuant to this Clause 7.3 requires the prior written approval of NOVARTIS.

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7.4 TSP . The Parties will use reasonable effort to agree the trading services terms and procedures, starting from the standard form attached hereto at Exhibit C, within ninety (90) days of the Effective Date.

7.5 Following receipt of a Delivery of Product, NOVARTIS or its designated agent shall, within fifteen (15) days, carry out a Visual Inspection of such shipment to ensure that: (i) Packaging and Labelling of the quantity of Product Delivered has taken place in accordance with the Specifications; and (ii) the Delivery is accompanied by an associated certificate of analysis, and if NOVARTIS determines in its sole discretion (exercised reasonably) that it has not so taken place it shall promptly notify rejection of the Delivery to GW in writing. Subject to the provisions of Clause 14 , if NOVARTIS does not notify GW of rejection of such Delivery within such 10 day period, such Delivery of Product shall be deemed to have been accepted.

8. Price / Payment

8.1 Price .

(a) The Price is based on “Direct Manufacturing Costs”, as defined in Annex 1 .

(b) The Price shall be capped in line with a “ Direct Manufacturing Cost Cap ”, as described below:

(i) for the *** years following the First Commercial Sale in the Territory GBP *** per vial of Product; and

(ii) thereafter, GBP *** per vial of Product subject to Inflation Adjustment.

(c) The Price is the lesser of (i) the Direct Manufacturing Costs plus ***% thereof, or (ii) the Direct Manufacturing Cost Cap plus ***% thereof.

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(d) Subject to Clause 8.1(e) , the Direct Manufacturing Cost Cap under Clause 8.1(b)(ii) may be adjusted according to yearly inflation as follows:

(i) the element of the Direct Manufacturing Cost within part (ii) of that definition will be increased by the lesser of (a) the actual increase in GW’s direct labour costs, and (b) the annual rate of inflation, as determined using the Index of Labour Costs per Hour industry level specifically for Manufacture of chemicals, chemical products and man made fibres as published by the office by National Statistics, calculated by averaging the quarterly index data points for the preceding 4 quarters and calculating the % increase over the average of the four quarterly data points for the prior year.

(ii) the elements of Direct Manufacturing Cost within parts (i), (iii) and (iv) of that definition will be increased to reflect the actual increase in the cost of each such element incurred by GW (as evidenced by GW’s records),

(the “ Inflation Adjustment ”). For clarity, Inflation Adjustment cannot be used to reduce the Direct Manufacturing Cost or any element thereof.

(e) The Inflation Adjustment to the Direct Manufacturing Cost Cap in a Contract Year to be borne by GW is capped to a maximum of *** percent (***%) (the “ Inflation Cap ”). GW will cover the aggregate Inflation Adjustment up to a maximum level of *** percent (***%) of the then current Direct Manufacturing Costs Cap. Increases above the Inflation Cap will be covered by NOVARTIS and the Direct Manufacturing Cost Cap in Clause 8.1(b)(ii) will be adjusted accordingly. After each actual adjustment of the Direct Manufacturing Cost Cap in Clause 8.1(b)(ii) made under this Clause 8.1(e) the inflation baseline shall be reset to ***%.

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An example of the Inflation Adjustment mechanism is shown in Annex 4 .

(f) Inflation Adjustment of the Direct Manufacturing Cost Cap under Clause 8.1(b)(ii) will apply from the start of the ***. Contract Year Prior to 31 January in each Contract Year following Contract Year in which First Commercial Sale occurs in the Territory the Parties shall meet and shall agree the amount by which Gw’s Direct Manufacturing Cost for a vial of product has increased due to inflation. GW shall prepare and present to NOVARTIS the necessary records to evidence its actual increases for the items in Clause 8.1(d)(ii) . Once the Inflation Adjustment for a Contract Year has been agreed the Parties shall apply the provision of Clause 8.1(e) and agree upon the required change (if any) to the Direct Manufacturing Cost Cap in Clause 8.1(d)(ii) for the then current Contract Year.

8.2 Payment Terms .

(a) GW shall provide NOVARTIS with an invoice setting forth the Price due and payable for each Delivery of Product made under this Agreement. Each such invoice shall, to the extent applicable, identify the Firm Order numbers, product numbers, quantities of Product and the total amount to be remitted by NOVARTIS.

(b) NOVARTIS shall pay all correctly submitted invoices within *** calendar day of the receipt of such invoice, unless otherwise agreed upon in writing by the Parties.

(d) All payments under this Agreement shall be made free and clear of and without set off, deduction or deferment in respect of any taxes, disputes or claims whatsoever.

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(e) The Price is expressed to be exclusive of any sales or value added tax which may be due on any supply of Product and NOVARTIS shall pay to GW in addition all such sales and value added tax for which GW is liable to account to the relevant tax authorities in relation to any supply made or deemed to be made for sales or value added tax purposes under this Agreement on receipt of a tax invoice or invoices from GW.

(f) All payments made to GW under this Agreement shall be made by wire transfer to the bank account that may be notified by GW to NOVARTIS from time to time.

8.3 Open Book . In order to allow the Parties to have a constructive discussion on annual Price review, GW shall supply to NOVARTIS at NOVARTIS’ request a fully transparent and detailed cost calculation according to the principles of “ open book ”. GW will share with NOVARTIS details of the costs of Approved Subcontractors.

8.4 Cost Improvement Benefit Sharing .

(a) GW agrees to pursue a continuous improvement strategy and shall confer with NOVARTIS on a regular basis (at least once annually) to consider whether new technologies or manufacturing processes may exist which would likely improve the Processing performance at the Facility and reduce the Processing and materials costs. NOVARTIS agrees to support GW in implementing process improvement methodologies.

(b) Any achieved process improvement which yields a reduction of the Direct Manufacturing Costs following the second anniversary of First Commercial Sale in the Territory (“ Cost Improvement Benefit ”) will be *** by the Parties (“ Cost Improvement Benefit Sharing ”). Cost Improvement Benefit Sharing will only become effective once the Direct Manufacturing Costs have become lower than the Direct Manufacturing Cost Cap set forth in Clause 8.1(b)(ii). When calculating the Cost Improvement Benefit and the Cost Improvement Benefit Sharing (i) the Parties shall not include in their calculations any Inflation Adjustment of the Direct Cost Cap set forth in Clause 8.1(b)(ii), and (ii) the baseline against which the Direct Manufacturing Costs will be compared in order to assess whether there is a Cost Improvement Benefit to be shared for the Cost Improvement Benefit Sharing will only be adjusted every second Contract Year. An example of the Cost Improvement Benefit Sharing calculation is shown in Annex 5 .

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9. Quality Assurance

9.1 QA Agreement . The Parties shall enter into a separate QA Agreement, in the agreed form attached at Exhibit B to this Agreement, relating to the Parties’ QA responsibilities and in particular addressing the following (but without limitation): documents, records, samples, change management and approval, inspections, complaints, recalls, testing and release.

10. Change Control

10.1 Changes Not Triggered by Law or by Regulatory Authorities . This Clause 10.1 shall not be applicable to Legal/Regulatory Changes.

(a) The Parties shall comply with the documented change control procedure set out in the QA Agreement for any change affecting the Marketing Authorizations relating to the Product in the Territory (a “Change” ). NOVARTIS will not withhold any required consent to a Change (if any) where the Change that is to be made affects how Product is Processed for Commercialization both inside and outside the Territory.

(b) All implementation costs incurred by either Party in relation to any Change, including the project, qualification, development, Validation, investment, stability testing, and regulatory submission costs, shall be borne by the initiator of the Change. In case of destruction of Packaging Material or other Components as a result of a Change, such

costs shall include costs of discard of such materials at purchase price value without mark-up. In case NOVARTIS shall bear any cost, the cost shall be calculated by GW and, unless otherwise agreed to by NOVARTIS, approved by NOVARTIS before any implementation of the Change.

10.2 Changes Triggered by Law or by Regulatory Authorities

(a) If any applicable Law or Regulatory Authority requires any Change (a “ Legal/Regulatory Change ”), the Party becoming aware of the required Change shall promptly notify the other Party accordingly and shall provide the other Party with copies of any documents delivered to it by the relevant Regulatory Authority, as the case may be, as soon as reasonably practicable following the receipt of such documents.

(b) The Parties shall then agree on a plan to implement the Legal/Regulatory Change with a target completion date. Subject to any timeframe imposed by the applicable Law or the relevant Regulatory Authority, GW shall use reasonable efforts to ensure that the implementation of the Legal/Regulatory Changes be deferred to allow NOVARTIS time to amend any relevant Marketing Authorization. In case a timeframe is imposed by the applicable Law or the relevant Regulatory Authority, GW shall implement the Legal/Regulatory Changes within the timeframe required by the Regulatory Authority or applicable Law.

(c) All costs of either Party that are related to recording with Regulatory Authorities any Legal/Regulatory Change shall be borne by GW except where the Legal/Regulatory Change relates exclusively to the Processing and/or Delivery of Product for the Territory or any part thereof, in which case the costs incurred by either Party related to recording the Legal/Regulatory Change with Regulatory Authorities shall be borne by NOVARTIS. In case any Packaging Material or other Component must be discarded due to a Legal/Regulatory Change, NOVARTIS shall bear the costs relating to a

Legal/Regulatory Change in accordance with this Clause 10.2 and shall be responsible for the cost of discarding such materials at purchase price value without mark-up.

10.3 Implementation of Changes. GW will promptly inform NOVARTIS of any and all Changes that are to be made to the Process before any such Change is implemented and will also promptly inform NOVARTIS of any impact the implementation of such a Change is likely to have on the Direct Manufacturing Cost. GW will not stop Processing according to an existing Process or at an existing Facility until the relevant Change has been Validated (if applicable), all necessary Registrations received and the necessary changes have been made to NOVARTIS’ Regulatory Approvals in any particular country. NOVARTIS will make such changes as soon as reasonably practicable and notify GW when these changes have been made.

10.4 Changes and Price.

(a) *** shall bear any increase in its Direct Manufacturing Cost above the Direct Manufacturing Cost Cap resulting from the manufacture of Product pursuant to either (i) a changed Process where such Change was initiated by *** pursuant to Clause 10.1 and/or (ii) a changed Process where the costs of recording such Change with Regulatory Authorities is *** responsibility under Clause 10.2 .

(b) *** will bear any increase in *** Direct Manufacturing Cost resulting from the manufacture of Product pursuant to a changed Process where such Change is initiated by *** pursuant to Clause 10.1 or the Change is a Legal/Regulatory Change that relates exclusively to the Processing and/or Delivery of Product for the Territory or any part thereof. This Clause 10.4(b) shall operate in addition to the Price adjustment provisions set forth in Clause 8 and any resulting Direct Manufacturing Costs shall be in addition to the Direct Manufacturing Cost Cap.

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11. QA Audits and Inspections

11.1 Novartis’ Right of Inspection . GW will ensure that NOVARTIS and/or its Affiliates will have the right to audit the Facility, the equipment used in the Processing or storage of Product, BDS and Components, and the Approved Subcontractors. Such audits may include (i) initial GMP-baseline Audits, (ii) for cause/event audits, and/or (iii) audits for special cases in which NOVARTIS` representatives may be present during the Processing of the Product. GW shall keep reasonable quantities of samples of BDS, Components and Product for examination purposes to verify GW’s compliance with the Specifications and its obligations under this Agreement. Representatives of NOVARTIS will have access during audits to all documents, records, reports (excluding full audit reports), data, procedures, facilities, regulatory submissions, and all other information required to be maintained by the EMA, by Law. NOVARTIS may audit GW’s and the Approved Subcontractors’ reports and records relating to the Processing pursuant to this Agreement during normal business hours and with reasonable advance written notice, and a GW representative may be present during any such inspection. The exact timelines for audits, including without limitation, the intervals and the number of days for the prior written notice, will be set forth in the QA Agreement.

11.2 Regulatory Authorities’ Right of Inspection . GW shall permit, and cause to be permitted at its Approved Subcontractors, authorized officials of any Regulatory Authorities or other competent governmental agencies to inspect the Facility, including the equipment, used for the Processing or storage of Product, BDS and/or Components, as required or necessary for the granting or maintaining of any Registration.

11.3 Survival . The rights under this Clause shall survive 5 (five) years from termination or expiration of this Agreement.

12. Financial Audits

12.1 Financial Audit Rights . GW shall keep, and procure that its Affiliates keep, complete, true and accurate books and records in accordance with its Accounting Standards in sufficient detail for NOVARTIS to determine the

Direct Manufacturing Costs from time to time. GW will keep such books and records for at least three (3) Contract Years following the end of the fiscal year to which they pertain. NOVARTIS may, upon written request and at its expense (except as provided for in Clause 12.2 ), cause an internationally-recognized independent accounting firm selected by it (except one to whom GW has a reasonable objection), (the “ Audit Team ”) to audit during ordinary business hours, at such place or places as they are customarily kept, the books and records of GW and its Affiliates for a given Contract Year and the correctness of the Direct Manufacturing Cost in such year. Prior to commencing its work pursuant to this Agreement, the Audit Team shall enter into an appropriate confidentiality agreement with GW. In respect of each audit of GW’s books and records: (i) GW shall be audited not more frequently than once per Contract Year; (ii) no records for any given Contract Year may be audited more than once; and (iii) NOVARTIS shall only be entitled to audit books and records of GW from the three (3) Contract Years prior to the Contract Year in which the audit request is made. In order to initiate an audit for a particular Contract Year, NOVARTIS must provide written notice to GW, which notice shall include one or more proposed dates for the audit and which notice shall be given not less than forty-five (45) days prior to the first proposed audit date. GW will reasonably accommodate the scheduling of such audit. GW shall provide the Audit Team(s) with full and complete access to the applicable books and records and otherwise reasonably cooperate with such audit. GW shall have the right to request a further determination by such Audit Team as to matters which GW disputes within thirty (30) days following receipt of such report. GW will provide NOVARTIS and the Audit Team with a reasonably detailed statement of the grounds upon which it disputes any findings in the audit report and the Audit Team shall undertake to complete such further determination within thirty (30) days after the dispute notice is provided, which determination shall be limited to the disputed matters. If the Parties disagree as to such further determination, the Parties agree that they shall use reasonable efforts, through the participation of finance representatives of both companies, to resolve any dispute arising in relation to any audit conducted hereunder by good faith discussion. If, despite using such good faith efforts, the Parties are unable to resolve an audit related dispute

NOVARTIS and GW shall mutually select an internationally recognized independent accounting firm that shall make a final determination as to the remaining matters in dispute, which determination shall be binding upon the Parties. Neither the Audit Team, nor any accountants appointed under this Clause 12.1 shall disclose to NOVARTIS any information relating to the business of the Auditee except that which should properly have been contained in any report required hereunder or is otherwise required to be disclosed to such Party to verify the payments required to be made pursuant to the terms of this Agreement.

12.2 If the Parties discover, whether by audit or otherwise, that the Direct Manufacturing Cost has been overstated during a particular Contract Year, NOVARTIS may deduct such overpayments from subsequent payments due under Clause 8.2 until the full amount that NOVARTIS was entitled to receive is deducted, except that the maximum amount that may be deducted from a single payment under Clause 8.2 is ***% of the amount otherwise payable. If the full amount cannot be deducted from such subsequent amounts, GW shall promptly pay to NOVARTIS the amount of any such overpayment within sixty (60) days of receiving an invoice from NOVARTIS, which invoice may be submitted upon termination or expiration of this Agreement If the Parties discover whether by audit or otherwise, that NOVARTIS has made an underpayment, GW will add such underpayment to subsequent invoices, except that the maximum amount that may be added in a single invoice is ***% of the amounts otherwise payable under that invoice. Further, if the audit for any one or more Contract Years shows an over-reporting an overcharge by GW for that period in excess of *** percent (***%) of the amounts properly determined, GW shall reimburse NOVARTIS for its out-of-pocket expenses, including the fees and expenses paid by it to the Audit Team(s), in connection with said audit, which reimbursement shall be made within forty-five (45) days of receiving appropriate invoices and other support for such audit-related costs.

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12.3 Survival . The rights under this Clause shall survive 5 (five) years from termination or expiration of this Agreement.

13. Exchange of information

Without prejudice to NOVARTIS` rights to information set forth in the QA Agreement, the Parties shall continually exchange information and experiences in all matters pertaining to the Processing of the Product and Quality Assurance via the Alliance Managers and shall inform each other promptly in writing regarding all matters which could jeopardize the Processing of the Product whether for scientific, legal, regulatory or other reasons.

14. Counterfeit and Defective Product

14.1 Notification . In the event that GW Delivers any Defective Product to NOVARTIS, NOVARTIS shall inform GW thereof in accordance with the terms and timelines set forth in the QA Agreement.

14.2 Right of Rejection . NOVARTIS shall have, at its sole discretion, the right to reject any Defective Product or to reject any Batch containing any Defective Product.

14.3 Replacement of Defective Product . In the event GW Delivers any Defective Product to NOVARTIS and subject to NOVARTIS’ timely notification (as set forth in the QA Agreement), and subject always to Clause 14.4 below, GW shall replace any such Defective Product or, at NOVARTIS’ sole discretion, any Batch containing such Defective Product, with conforming Product or conforming Batch of Product, as the case may be, at GW’s cost. In addition, GW shall bear sole responsibility for all costs associated with the transportation, testing and disposal (as applicable) of any rejected Defective Product or Batch containing Defective Product. GW shall use commercially reasonable efforts to complete such replacement as soon as practicable and in any event within one (1) month of NOVARTIS’ notification. GW shall not rework or reprocess any rejected Defective Product, unless expressly authorized in writing to do so by NOVARTIS each time.

14.4 Defective Product caused by Novartis . In the event that any such Defective Product became defective after Delivery of such Product to NOVARTIS as a result of the actions or breach of NOVARTIS, GW shall not bear any cost thereof, but NOVARTIS shall pay the Price for such Defective Product supplied by GW. GW shall use commercially reasonable efforts to complete such replacement as soon as practicable and in any event within one (1) month of NOVARTIS’ notification.

14.5 Dispute Resolution . In the event of an unresolved dispute as to whether any quantity or Batch of Product contains any Defective Product, GW shall undertake the relevant (re)testing of a quantity of the Product which is alleged to be Defective Product and/or a retained sample of Product from the Batch in question as follows:

(i) where the required (re)testing is solely the (re)testing of a sample of Product from the disputed Batch retained by GW and the (re)testing does not require microtesting by a Third Party laboratory, GW shall complete such (re)testing within thirty (30) days of NOVARTIS notifying GW in writing pursuant to Clause 14.1 that it is rejecting the quantity/Batch in question as Defective Product;

(ii) where the required (re)testing necessitates the (re)testing of a sample of Product from the delivered Batch and the (re)testing does not require microtesting by a Third Party laboratory, GW shall complete such (re)testing within thirty (30) days of (a) NOVARTIS notifying GW in writing pursuant to Clause 14.1 that it is rejecting the quantity/Batch in question as Defective Product, and (b) NOVARTIS delivering to GW a sample of Product from the disputed quantity/Batch in question;

(iii) where the required (re)testing under (i) or (ii) above requires microtesting by a Third Party laboratory, the time periods in (i) and (ii) above for completing the (re)testing shall be sixty (60) days from the relevant start day.

Where Product from a Batch the subject of a notice under Clause 14.1 is to undergo (re)testing, such (re)testing shall be conducted at a time mutually

agreed with NOVARTIS and with a representative of NOVARTIS in attendance. The findings of such (re)testing shall be conclusive and binding upon the Parties. All fees and expenses of the said laboratory shall be borne solely by the unsuccessful Party. The Parties agree that during the resolution of any such dispute, GW shall, irrespective of the final allocation of the cost for the replacement of Defective Product, supply any replacement of Defective Product requested by NOVARTIS free of charge, and, if applicable, NOVARTIS shall pay GW for such replacement Product as appropriate in accordance with the results/decisions made under this Clause 14.5 .

14.6 Counterfeit Goods. If NOVARTIS believes that counterfeit Product is being Commercialized in one or more countries in the Territory, the Parties will collaborate to obtain samples of the material which is believed to be counterfeit Product and for GW to test such material to ascertain whether such material is counterfeit Product. If the material in question is shown to be counterfeit the Parties will collaborate to have it removed from the market.

15. Continuous Improvement /Business Continuity

15.1 Continuous Improvement. The Parties agree to pursue a mutual continuous improvement program and shall confer on a regular basis (at least annually) to consider whether new technologies or manufacturing processes may exist which would likely improve the Processing performance at the Facility and reduce the Processing and materials costs.

15.2 KPIs . Following the Initial Period, GW commits to use commercially reasonable efforts to reach and consistently maintain a target of *** percent (***%) for the KPIs. In the event GW fails to meet a KPI with respect to a particular Firm Order, within thirty (30) days of such KPI failure GW shall (i) investigate the cause of such failure and (ii) report the results of the investigation to NOVARTIS in writing along with a plan of the actions to be taken by GW to prevent or minimize the likelihood of such cause contributing

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to a future failure to meet a KPI. At NOVARTIS’ request GW will discuss such a report and plan of action with NOVARTIS. Thereafter, GW will report to NOVARTIS on a regular basis its progress with implementing each plan of action.

15.3 Risk Management . In order to ensure continuity of supply and in connection with diligent risk management practices, GW will develop, implement and keep current a risk management program including a Business Continuity Plan. The Business Continuity Plan shall detail strategies for responses to and recovery from a range of potential disruptive events. Upon NOVARTIS` request GW will make such Business Continuity Plan available to NOVARTIS or its designated representatives for review. Such Business Continuity Plan shall, at a minimum, identify available alternative facilities, infrastructure and adequate inventories, and shall provide for security and protective measures necessary to ensure minimal impact of the range of potential disruptive events on NOVARTIS. The Business Continuity Plan does not relieve GW from any liability under this Agreement. In no event shall GW increase the Price as a result of the development, existence or implementation of the Business Continuity Plan. Once a year or at any other frequency as NOVARTIS reasonably deem to be appropriate, GW will conduct a test and evaluation of the Business Continuity Plan which, upon NOVARTIS` request, may be witnessed by NOVARTIS representatives to ensure systematic and process responsiveness of GW. The Parties agree that any issues arising from the risk and business continuity management activities will be promptly communicated to the other Party.

16. Product Recalls and Returns

16.1 Product Recall . Each Party shall give prompt notice by telephone (to be confirmed in writing) to the QA contact of the other Party upon discovery that the Product should be recalled or corrected, or may be required to be recalled or corrected.

16.2 Recall Responsibility . The decision to initiate a recall or to take some other corrective action, if any, shall be made and implemented by NOVARTIS

where it is the Marketing Authorisation holder in the affected country in the Territory and by GW where its is the Marketing Authorisation holder in the affected country in the Territory. The recall procedure is set forth in the QA Agreement.

16.3 Customer Returns and Product Recalls . NOVARTIS shall have responsibility for handling returns of the Product from its customers in the Territory pursuant to a Product Recall. GW shall provide NOVARTIS with such assistance as NOVARTIS may reasonably need to handle such returns. In the event of a return, at NOVARTIS’ request and cost (other than where the returned Product was Defective Product at the time it was Delivered by GW — in which case Clause 14.3 shall apply), GW shall use its commercially reasonable efforts to replace the returned Product with new Product within one (1) month from the date that NOVARTIS notifies GW about the returned Product.

16.4 Cost . Where a Recall or customer’s return of Product pursuant to a Product Recall is caused solely by GW, GW shall (i) replace the Recalled or returned Product as a matter of urgency with compliant Product, and (ii) reimburse NOVARTIS for all return and destruction costs incurred by NOVARTIS in connection with such Recall or customer return of Product pursuant to a Product Recall. In all other cases, NOVARTIS shall bear the costs of the Recall or customer return, including by paying GW the Price for any Recalled or returned Product (to the extent GW has not already been paid the same).

16.5 Pharmacovigilance Agreement . The Parties agree to adhere to the terms and conditions of the Pharmacovigilance Agreement, the agreed form of which is attached hereto as Exhibit 2 , which defines how the Parties are to cooperate to enable each of them to comply with its respective obligations under applicable laws, regulations and guidelines with regard to Adverse Event data collection, analysis and reporting for the Product, both pre and post-marketing, and to enable each Party to satisfy its duty of care.

17. Intellectual Property

17.1 NOVARTIS and GW agree that the provisions of Section 8 of the Distribution and License Agreement shall apply to this Agreement. Notwithstanding the foregoing sentence, all Intellectual Property generated, developed or created by either Party arising out of or in connection with the performance of this Agreement will belong to and vest in GW, and NOVARTIS will offer reasonable assistance, including providing any needed information and disclosures, to GW as needed to secure patent protection for such resulting Intellectual Property.

18. Liabilities and Indemnity

18.1 Indemnification by GW . GW shall indemnify and hold Novartis, its Affiliates and Sublicensees, and their respective officers, directors and employees (“ Novartis Indemnitees ”) harmless from and against any Claims to the extent arising or resulting from a breach of the Product Warranties where it is proved that such Product did not meet the Product Warranties, provided, however, that GW shall not be obliged to so indemnify, defend and hold harmless the Novartis Indemnitees for any Claims which arise as a result of the negligence or willful misconduct of NOVARTIS or any of its Affiliates or Sublicensees.

18.2 Indemnification Procedure.

(a) For the avoidance of doubt, all indemnification claims in respect of a Novartis Indemnitee shall be made solely by NOVARTIS.

(b) NOVARTIS shall notify GW in writing reasonably promptly after the assertion against NOVARTIS or other Novartis Indemnitee of any Claim or fact in respect of which the NOVARTIS intends to base a claim for indemnification hereunder (“ Indemnification Claim Notice ”), but the failure or delay to so notify GW shall not relieve GW of any obligation or liability that it may have to NOVARTIS, except to

the extent that GW demonstrates that its ability to defend or resolve such Claim is adversely affected thereby. The Indemnification Claim Notice shall contain a description of the claim and the nature and amount of the Claim (to the extent that the nature and amount of such Claim is known at such time). Upon the request of GW, NOVARTIS shall furnish promptly to GW copies of all correspondence, communications and official documents (including court documents) received or sent in respect of such Claim.

(c) Subject to the provisions of sub-clauses (d) and (e) below, GW shall have the right, upon written notice given to NOVARTIS within thirty (30) days after receipt of the Indemnification Claim Notice to assume the defense and handling of such Claim, at GW’s sole expense, in which case the provisions of sub-clause (d) below shall govern. The assumption of the defense of a Claim by GW shall not be construed as acknowledgement that GW is liable to indemnify any Novartis Indemnitee in respect of the Claim, nor shall it constitute a waiver by GW of any defenses it may assert against NOVARTIS or a Novartis Indemnitee’s claim for indemnification. In the event that it is ultimately decided that GW is not obligated to indemnify or hold an NOVARTIS or a Novartis Indemnitee harmless from and against the Claim, NOVARTIS shall reimburse GW for any and all costs and expenses (including attorneys’ fees and costs of suit) and any losses incurred by GW in its defense of the Claim. If GW does not give written notice to NOVARTIS, within thirty (30) days after receipt of the Indemnification Claim Notice, of GW’s election to assume the defense and handling of such Claim, the provisions of sub-clause (e) below shall govern.

(d) Upon assumption of the defense of a Claim by GW: (i) GW shall have the right to and shall assume sole control and responsibility for dealing with the Claim; (ii) GW may, at its own cost, appoint as counsel in connection with conducting the defense and handling of such Claim any law firm or counsel reasonably selected by GW; (iii) GW shall

keep NOVARTIS informed of the status of such Claim; and (iv) GW shall have the right to settle the Claim on any terms GW chooses; provided, however, that it shall not, without the prior written consent of NOVARTIS, agree to a settlement of any Claim which could lead to liability or create any financial or other obligation on the part of NOVARTIS for which NOVARTIS is not entitled to indemnification hereunder or which admits any wrongdoing or responsibility for the Claim on behalf of NOVARTIS. NOVARTIS shall cooperate with GW and shall be entitled to participate in, but not control, the defense of such Claim with its own counsel and at its own expense. In particular, NOVARTIS shall furnish such records, information and testimony, provide witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection therewith. Such cooperation shall include access during normal business hours by GW to, and reasonable retention by NOVARTIS of, records and information that are reasonably relevant to such Claim, and making NOVARTIS, the Novartis Indemnitees and its and their employees and agents available on a mutually convenient basis to provide additional information and explanation of any records or information provided.

(e) If GW does not give written notice to NOVARTIS as set forth in sub-clause (c) or fails to conduct the defense and handling of any Claim in good faith after having assumed such, NOVARTIS may, at GW’s expense, select counsel reasonably acceptable to NOVARTIS in connection with conducting the defense and handling of such Claim and defend or handle such Claim in such manner as it may deem appropriate. In such event, NOVARTIS shall keep GW timely apprised of the status of such Claim and shall not settle such Claim without the prior written consent of GW, which consent shall not be unreasonably withheld. If NOVARTIS defends or handles such Claim, GW shall cooperate with NOVARTIS, at NOVARTIS’ request but at no expense to NOVARTIS, and shall be entitled to participate in the

defense and handling of such Claim with its own counsel and at its own expense.

18.3 Mitigation of Loss . NOVARTIS will take and will procure that the Novartis Indemnitees take all such reasonable steps and actions as are necessary or as GW may reasonably require in order to mitigate any Claims (or potential losses or damages) under this Clause 18 . Nothing in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it.

18.4 No double recovery . NOVARTIS shall not be entitled to recover from GW hereunder:

(a) more than once in respect of the costs/losses suffered relating to the same Claim; or

(b) in any instance where the Claim has been indemnified, recovered or otherwise compensated as a result of any other provision of this Agreement or the Distribution and License Agreement.

18.5 Special, Indirect and Other Losses NEITHER PARTY NOR ANY OF ITS AFFILIATES SHALL BE LIABLE IN CONTRACT, TORT, NEGLIGENCE BREACH OF STATUTORY DUTY OR OTHERWISE FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF PROFITS SUFFERED BY THE OTHER PARTY.

18.6 No Exclusion. Neither Party excludes any liability for death or personal injury caused by its negligence or that of its employees, agents or subcontractors.

19. Confidentiality

19.1 NOVARTIS and GW agree that the provisions of Section 9 of the Distribution and License Agreement shall apply to the Confidential Information disclosed hereunder as if such information were Confidential Information for the purposes of the Distribution and License Agreement.

20. Term

20.1 Term . This Agreement shall come into force on the Effective Date and, subject to earlier termination pursuant to Clause 21 shall expire upon expiration or termination of the Distribution and License Agreement.

21. Extraordinary Termination

21.1 Termination due to Material Breach . Upon failure of any Party to remedy its material breach of any of its obligations under this Agreement within *** days following receipt of written notice of said breach from the other Party (except for a breach of the NOVARTIS Policy Statement, for which there shall be no right to remedy), the Party giving such notice shall have the right but not the obligation to terminate this Agreement immediately (or such longer period of time as such Party shall determine) by written notice.

21.2 Termination due to Liquidation . GW or NOVARTIS at its sole option may immediately terminate this Agreement upon written notice, but without prior advance notice, to the other Party upon the liquidation, dissolution, winding-up, insolvency, bankruptcy, assignment for the benefit of creditors, or filing of any petition therefore, appointment of a receiver, custodian or trustee, or any other similar proceeding, by or of the other Party where such petition, assignment or similar proceeding is not dismissed or vacated within ninety (90) calendar days.

22. Effects of Termination or Expiration

22.1 Technology Transfer . In the event of the termination of this Agreement by NOVARTIS in accordance with Clauses 21.1 or 21.2 GW and its Affiliates will co-operate, and cause the Approved Subcontractors to co-operate, in good faith with NOVARTIS to bring about a smooth and orderly transition of the Process for producing Product from BDS to a new supplier (including an Affiliate of NOVARTIS). During such transition period (estimated to be approximately twenty-four (24) months), GW and its Approved

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Subcontractors shall continue to supply Product pursuant to the terms and conditions set forth herein. Following the transition period GW shall supply to NOVARTIS all necessary quantities of BDS and the provisions of Clauses 2, 3, 5, 7, 8.1-8.3, 9, 10, 11, 12, 14.1-14.5, 16, 17, 18 and 19 shall apply to such supply of BDS.

22.2 Survival . Except as otherwise expressly provided, termination or expiration of this Agreement will not affect any rights and obligations which, from the context thereof, are intended to survive termination or expiration of this Agreement, nor shall it prejudice any other remedies that the Parties may have under this Agreement. Upon expiration or termination of this Agreement all outstanding unpaid invoices shall become payable immediately in place of the payment terms previously agreed by the Parties. The terms of Clauses 8.3, 11, 12, 17, 18, 19, 22.2, 23 and 24 shall survive termination on expiration of this Agreement and continue in full force and effect in accordance with their respective terms.

22.3 Bridging Stock . Upon notice of termination (except for termination by GW in accordance with Clauses 21.1 or 21.2 ), NOVARTIS will have the option (valid until the effective date of expiration or termination) to purchase an additional quantity of Product (“ Bridging Stock ”) of up to *** years demand based on *** percent (***%) of the quantity forecasted by NOVARTIS for the year in which the Agreement is terminated at the Price in force at the time of termination of this Agreement. NOVARTIS shall exercise its option for the Bridging Stock by providing GW with a purchase order for the desired quantities of the Bridging Stock and on a delivery schedule to be agreed by the Parties in good faith.

23. Governing Law / Dispute Resolution

23.1 Governing Law . This Agreement will be governed by and construed under the laws in effect in the State of New York, without giving effect to the conflicts of laws provision thereof. The United Nations Convention on

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Contracts for the International Sale of Goods (1980) will not apply to the interpretation of this Agreement.

23.2 Dispute Resolution .

(i) In the event of a dispute under this Agreement, the Parties will refer the dispute to the Alliance Managers for discussion and resolution. If the Alliance Managers are unable to resolve any such dispute within thirty (30) days of the dispute being referred to them, either Party may require that the Parties forward the matter to the Senior Officers (or designees with similar authority to resolve such dispute), who shall attempt in good faith to resolve such dispute. If the Senior Officers cannot resolve such dispute within thirty (30) days of the matter being referred to them, either Party shall be free to initiate the arbitration proceedings outlined in sub-Clause (ii) below.

(ii) Any unresolved disputes between the Parties relating to, arising out of or in any way connected with this Agreement or any term or condition hereof, or the performance by either Party of its obligations hereunder, whether before or after termination of this Agreement, shall be resolved by final and binding arbitration. Whenever a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. Arbitration shall be held in New York, New York, USA, according to the commercial rules of the International Chamber of Commerce (“ ICC ”). The arbitration will be conducted by a panel of three arbitrators appointed in accordance with ICC rules; provided that each Party shall, within thirty (30) days after the institution of the arbitration proceedings, appoint an arbitrator, and such arbitrators shall together, within thirty (30) days, select a third arbitrator as the chairman of the arbitration panel. Each arbitrator shall have significant experience in the pharmaceutical business. If the two initial arbitrators are unable to select a third arbitrator

within such thirty (30) day period, the third arbitrator shall be appointed in accordance with ICC rules. Discovery shall be subject to all applicable privileges and other immunities under the U.S. Federal Rules of Civil Procedure and shall be limited to: (i) the production of documents available in the ordinary course of business in accordance with the producing Party’s standard document retention policies within specified relevant categories from no more than ten (10) individual representatives of the producing Party who have been identified by the other Party in its document request; (ii) two (2) depositions per side; and (iii) ten (10) interrogatories per side. The Parties shall request that the arbitrators render their opinion within thirty (30) days of the final arbitration hearing. No arbitrator (nor the panel of arbitrators) shall have the power to award punitive damages under this Agreement and such award is expressly prohibited. Decisions of the panel of arbitrators shall be final and binding on the Parties. Judgment on the award so rendered may be entered in any court of competent jurisdiction. The losing Party to the arbitration (if any) as determined by the arbitrators shall pay the costs of the arbitration.

23.3 Remedy for Breach . The Parties understand and agree that monetary damages may not be sufficient remedy for breach of this Agreement and that the injured Party will be entitled to seek equitable relief, including injunction and specific performance, for any such breach.

24. Miscellaneous

24.1 Relationship of the Parties. Nothing contained in this Agreement will be deemed to constitute a partnership, joint venture, or legal entity of any type between NOVARTIS and GW, or constitute one as the agent of the other. Moreover, each Party agrees not to construe this Agreement, or any of the transactions contemplated hereby, as a partnership for any tax purposes. each Party will act solely as an independent contractor, and nothing in this

Agreement will be construed to give any Party the power or authority to act for, bind, or commit the other.

24.2 Notices. All notices, consents, waivers, and other communications under this Agreement must be in writing and will be deemed to have been duly given when: (i) delivered by hand (with written confirmation of receipt); or (ii) sent by facsimile (with provision for assurance of receipt in a manner typical with respect to communications of that type); or (iii) when received by the addressee, if sent by an internationally recognized overnight delivery service, in each case to the appropriate addresses set forth below (or to such other addresses as a Party may designate by written notice):

If to GW:

GW Pharma Limited

Porton Down Science Park

Salisbury,

Wiltshire

SP4 0JQ

United Kingdom

Attention: Managing Director

Fax number: +44 1980 557111

If to NOVARTIS:

NOVARTIS PHARMA AG
Lichtstrasse 35
4056 Basel, Switzerland

Attn : Global Head of TechOps

Fax: +41 61 3243060

With a copy to :

Attn : Head of Legal TechOps

Fax: +41 61 3247399

24.3 Further Assurances. GW and NOVARTIS hereby covenant and agree without the necessity of any further consideration, to execute, acknowledge and deliver any and all such other documents and take any such other action as

may be reasonably necessary to carry out the intent and purposes of this Agreement.

24.4 Compliance with Law. Each Party will perform its obligations under this Agreement in accordance with all applicable Laws. No Party will, or will be required to, undertake any activity under or in connection with this Agreement which violates, or which it believes, in good faith, may violate, any applicable Law.

24.5 No Third Party Beneficiary Rights. The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they will not be construed as conferring any rights to any Third Party (including any third party beneficiary rights).

24.6 English Language. This Agreement is written and executed in the English language. Any translation into any other language will not be an official version of this Agreement and is solely for reference. In the event of any conflict in interpretation between the English version and such translation, the English version will prevail.

24.7 Force Majeure. Failure of any Party to perform its obligations under this Agreement (other than of the obligations to make any payments or of confidentiality) shall not subject such Party to any liability or place them in breach of any term or condition of this Agreement to the other Party if, and solely to the extent, such failure is caused by Force Majeure. The corresponding obligations of the other Party will be suspended to the same extent. “ Force Majeure ” shall mean any unanticipated event beyond a Party’s reasonable control that could not be avoided by due care of such non-performing Party, including without limitation, acts of God, fire, explosion, flood, earthquake, drought, war, hostility, revolution, riot, civil disturbance, national emergency, sabotage, embargo, but excluding strikes or other labour trouble at a Facility; provided, however, that the Party affected shall promptly notify the other Party of the condition constituting Force Majeure as defined herein and shall exert commercially reasonable efforts to eliminate, cure and overcome any such causes and to resume performance of its obligations with

all possible speed. If a condition constituting Force Majeure as defined herein prevents, or would likely prevent, a Party from performing its obligations under this Agreement for more than sixty (60) days, the Parties shall meet to negotiate a mutually satisfactory solution to the problem.

24.8 Entire Agreement. This Agreement, together with its Annexes, and the Distribution and License Agreement, the QA Agreement and the Pharmacovigilance Agreement sets forth the entire agreement and understanding of the Parties as to the subject matter hereof and supersedes all proposals, oral or written, and all other prior communications between the Parties with respect to such subject matter. In the event of any conflict between a substantive provision of this Agreement and any Annex hereto, the substantive provisions of this Agreement will prevail. In the event of any conflict between a substantive provision of this Agreement and a substantive provision of the Distribution and License Agreement, the substantive provisions of this Agreement will prevail with respect to any issues relating to Product manufacture and supply (including the Price and payment terms) and the substantive provisions of the Distribution and License Agreement will prevail with respect to any other term. In the event of any conflict between a substantive provision of this Agreement and a substantive provision of the QA Agreement, the substantive provisions of the QA Agreement will prevail with respect to any issues relating to Product Quality Assurance and the substantive provisions of this Agreement will prevail with respect to any other term. In the event of any conflict between a substantive provision of this Agreement and a substantive provision of the Pharmacovigilance Agreement, the substantive provisions of the Pharmacovigilance Agreement will prevail with respect to any issues relating to Adverse Event collection, analysis and reporting and the substantive provisions of this Agreement will prevail with respect to any other term.

24.9 Assignment. Neither Party may assign its rights and obligations under this Agreement without the other Party’s prior written consent, except that:

(i) either Party may assign its rights and obligations under this Agreement or any part hereof to one or more of its Affiliates

without the consent of the other Party, so long as such Affiliate is and remains an Affiliate. If the assignee ceases to be an Affiliate of the assigning Party for any reason the assignee will reassign this Agreement to GW or NOVARTIS, as applicable, upon ceasing to be an Affiliate; and

(ii) either Party may assign this Agreement in its entirety to an acquirer of all or substantially all of its business or assets to which this Agreement relates (meaning: (i) with respect to NOVARTIS, that this Agreement may only be assigned together with the personnel and infrastructure previously engaged directly in the Commercialization and filing for Regulatory Approval of Product in the Territory; and (ii) with respect to GW, that this Agreement may only be assigned together with both the GW Technology and GW Trademarks, all Product related license and/or collaboration agreements with licensees of the Product outside the Territory, and the personnel and infrastructure engaged directly in the Development and manufacture of the Product, and filing for Regulatory Approval of Product in the EU at the time of the assignment and on the condition that, at the time of the assignment, GW puts in place appropriate arrangements with any key personnel previously engaged directly in the Development and manufacture of the Product who are not being acquired by the Third Party to allow GW and NOVARTIS to continue to access the Product related Know How and knowledge held by these persons; and

(iii) GW may assign this Agreement by way of security only when both (i) such security interest covers all of GW’s assets to which this Agreement relates (meaning that this Agreement may only be assigned by way of security where such security interest also covers the GW Technology, GW Trademarks, all Product related license and/or collaboration agreements with licensees of the Product outside the Territory, and the

infrastructure engaged directly in the manufacture of the Product); and (ii) the assignee/security holder agrees that, in the event that it forecloses on, or otherwise exercises its security interest with respect to, any of the assets to which th is Agreement relates, it will pending repayment of the sums due to the assignee/security holder use reasonable endeavours to ensure continuity of supply of the Product to NOVARTIS; and

The assigning Party will provide the other Party with prompt written notice of any such assignment. Any permitted assignee will assume all obligations of its assignor under this Agreement (or related to the assigned portion in case of a partial assignment). Any attempted assignment in contravention of the foregoing will be void. Subject to the terms of this Agreement, this Agreement will be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns

24.10 Severability. Should one or more of the provisions of this Agreement become void or unenforceable as a matter of law, then this Agreement will be construed as if such provision were not contained herein and the remainder of this Agreement will remain in full force and effect. The Parties will use their commercially reasonable efforts to substitute for the invalid or unenforceable provision a valid and enforceable provision which conforms as nearly as possible with the original intent of the Parties.

24.11 Waivers and Amendments . The failure of any Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party. No waiver will be effective unless it has been given in writing and signed by the Party giving such waiver. No provision of this Agreement may be amended or modified other than by a written document signed by authorized representatives of each Party.

24.12 Expenses. Except as otherwise expressly provided in this Agreement, each Party will pay the fees and expenses of its respective lawyers and other

advisors and all other expenses and costs incurred by such Party incidental to the negotiation, preparation, execution and delivery of this Agreement.

24.13 Execution . This Agreement may be executed in two or more counterparts, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

24.14 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each will be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under law.

(REST OF PAGE LEFT BLANK INTENTIONALLY)

Signed by the duly authorized representatives of each of the Parties hereto as of the Effective Date.

NOVARTIS PHARMA AG


/s/ ***		/s/ ***
Name	***	Name	***
Title	Head Strategic Sourcing	Title	Strategic Sourcing Manager

GW Pharma Ltd


/s/ Justin Gover
Name	Justin Gover
Title	Managing Director

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

LIST OF ANNEXES AND EXHIBITS

ANNEX 1	Product and Pricing

ANNEX 2	NOVARTIS HSE Policy

ANNEX 3	NOVARTIS Policy Statement

ANNEX 4	Inflation Adjustment of the Manufacturing Direct Cost Cap

ANNEX 5	Cost Improvement Benefit Sharing

ANNEX 6	Components

EXHIBIT A	Agreed form Pharmacovigilance Agreement

EXHIBIT B	Agreed form QA Agreement

EXHIBIT C	Standard form Trading Services Procedure

ANNEX 1

PRODUCT AND PRICING

Batch size

*** — ***

Pricing

“ Direct Manufacturing Costs ” shall mean costs incurred by GW in the actual manufacturing of Product, established on a regular, standard basis in accordance with Accounting Standards as consistently applied by GW, expressed on a per unit basis. Direct Manufacturing Cost shall be calculated according to the principles of “open book” and include the following elements:

(iv) Costs of material used for manufacturing of Product, including costs of raw materials, excipients, consumables, intermediates needed for the manufacturing process, costs of packaging material, labels and other printed materials;

(v) Direct labor cost of production employees (including wages, labor and related payroll taxes and benefits) incurred or spent in the manufacturing of Product;

(vi) Overheads, including cost of building and equipment depreciation (including real estate leasehold improvement depreciation), repair and maintenance and leasing cost, indirect labor of production support employees and related payroll taxes and benefits, costs for personnel exercising controlling and supervisory functions, costs of indirect space such as the cost of a break room, costs of in-process control, costs of microbiological monitoring of production environment, costs for supplies, auxiliary materials and consumables and other operating expenses, costs of shop floor control systems, costs for cleaning

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

production buildings, occupancy costs (including rent, rates and service charges), costs of work clothes, taxes, insurance, material management, interim transportation and warehousing (including transportation to/from subcontractors and between manufacturing facilities), costs of purchasing department (including production accounting), costs of ensuring sufficient levels of safety, health and environment, costs of production scheduling, costs of maintaining the bills of materials, costs for technical support, plant management, administration and general services, costs of IT systems, quality assurance and quality control costs, costs for utilities and ecology, such as electricity, water, nitrogen, carbon dioxide, steam, air, deposition of solid or liquid waste, purification of effluent water, purification of waste air. The costs of equipment and buildings shall be based on the planned utilization of the equipment and buildings. Overhead shall be allocated to production proportionate to the usage of the manufacturing facility for actual manufacturing of Product using an appropriate allocation key such as space occupied or headcount. The costs of underutilization or idle capacity are not to be included in the Direct Manufacturing Costs. Overheads shall not include general corporate activities including, by way of example only, executive management, investor relations, business development, legal affairs, human resources and finance; and

(vii) Costs of Third Party sub-contract manufacturers. Such costs will include the actual amount paid including the benefit of any price reductions, payment or terms discounts or other reimbursements, such as volume discounts, that may be applicable to such purchases.

ANNEX 2

NOVARTIS HEALTH, SAFETY & ENVIRONMENTAL

PROTECTION POLICY

1. GW will have at all times available for GW use, an up-to-date Material Safety Data Sheet (MSDS) recording all of the information which is known to GW at the time of preparing the MSDS, which may be relevant to health, safety and/or environmental protection for BDS and each Component which is proprietary to GW and which will be used in the Processing of Product for NOVARTIS. GW agrees to comply in all respects with the applicable laws and regulations on health, safety and environmental protection and with generally accepted standards of health, safety and environmental protection.

2. The persons engaged in performing the manufacture shall have adequate training in health, safety and environmental protection issues associated with handling hazardous materials.

3. GW warrants that all waste will be disposed of in compliance with all applicable laws and regulations, and that discarded printed material and products are not illegally used.

4. GW shall use, handle and store all materials used to perform the manufacture under suitable containment conditions.

5. GW shall use, handle and store all Components and any other materials used to Process the Product in accordance with the MSDSs with caution and prudence, since not all of the characteristics are necessarily known. GW shall proceed on the basis of the toxicological and other safety information known to them as developers of the Product.

6. Any Components or any other materials which remain unused upon completion of the performance of Processing will be destroyed in accordance with GW procedures and in accordance with all applicable laws and regulations..

7. GW shall be fully liable with respect to any claim (whether from private parties or from public bodies), which may arise from GW’s failure to meet applicable occupational health, safety or environmental protection laws and/or regulations.

ANNEX 3

NOVARTIS POLICY STATEMENT

GW agrees to abide by the following policy statement, which is binding on all parties under contract with NOVARTIS, and is in support of the protection of internationally proclaimed human rights, ethical and legal behavior, fair, courteous and respectful treatment of others, and professionalism and good business practice.

Gifts, favours, kickbacks, entertainment or other offering of financial advantage to an official of a government or a government-controlled entity for the purpose of obtaining business or other services, as set out in the OECD Convention on Combating Bribery of Foreign Public Officials are not allowed. Gifts, favors or entertainment to non-governmental officials may be provided to others only if they meet all of the following criteria:

(a) they are consistent with government regulations and customary business practices;

(b) they are not excessive in value, and cannot be construed as a bribe or a pay-off;

(d) they will not embarrass NOVARTIS, GW, or the recipient if publicly disclosed.

GW hereby agrees that in its dealings on behalf of NOVARTIS, it will take no action, directly or indirectly, that is inconsistent with the language or spirit of this policy statement. GW further acknowledges and agrees that any such action will serve as grounds for immediate termination of this Agreement by NOVARTIS.

Further, NOVARTIS gives preference to third parties who share Novartis’ societal and environmental values, as set forth in the Novartis Policy of Corporate Citizenship, Guideline #5 Third Party Code:

http://www.novartis.com/about-novartis/corporate-citizenship/business-conduct/index.shtml

ANNEX 4

Inflation Adjustment of the Direct Manufacturing Cost Cap

***

	Inflation (initial baseline at Effective Date set to 100%)	Yearly inflation by end of year	New baseline set to 100% as soon 2% cap as been reached	Coverage by GW	Coverage by Novartis
Year 1
Year 2
Year 3
Year 4
Year 5
Year 6
Year 7
Year 8
Year 9
Year 10
Year 11

Note: Figures in table are illustrative only

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX 5

Cost Improvement Benefit Sharing

***

***:

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX 6

Components

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

EXHIBIT A

Agreed form Pharmacovigilance Agreement

Pharmacovigilance Agreement

Between

GW Pharma Limited
Porton Down Science Park
Salisbury
Wiltshire, UK
SP4 0J

Novartis Pharma AG
at
Lichtstrasse 35, CH-4056, Basel, Switzerland

Regarding

Sativex® (delta-9-tetrahydrocannabinol 27mg/m1 (from Tetranabinex® -
Cannabis sativa L. extract) and cannabidiol 25mg/m1 (from Nabidiolex® -
Cannabis sativa L. extract)

TABLE OF CONTENTS

			Page

Part 1.	General Principles		2

1.1	Scope		2
1.2	Language		2
1.3	Definition of Terms		2
1.4	Correspondence Files		2
1.5	Expedited Reporting Responsibility To Competent Authorities		3
	1.5.1	Clinical Studies	3
	1.5.2	Commercial Product Use and Spontaneous AE/SAE reports	5
	1.5.3	Literature	5
	1.5.4	Quality Complaints and Product Recalls	5
	1.5.5	Pharmacovigilance Database	6
	1.5.6	EU Qualified Person for Pharmacovigilance	6
	1.5.7	Medical Information In Relation to Pharmacovigilance	7
	1.5.8	PSURs/PADERs	8
1.6	Safety Data Exchange		8
	1.6.1	Method of Exchange	8
	1.6.2	Reconciliation of Reports	9
	1.6.3	Dictionary	9
1.7	Signal Detection and Risk Management		9
1.8	Updates to Core Safety Data Information and Product Label		10
1.9	Requests from Regulatory Authorities		11
1.10	Audits		12
1.11	Dispute Resolution		12
1.12	Confidentiality		12
1.13	Business Continuity		12
1.14	Critical Issues		13

Part 2.	Execution of Agreement		13

2.1	Amendments to Agreement		13
	2.1.1	Notices	13

Part 3.	Appendices		15

Part 4.	Signatories		16

Part 1. General Principles

1.1 Scope

This Pharmacovigilance Agreement for Sativex® (“PV Agreement”) is made and entered into as of the date of last signature (the “PV Agreement Date”), by and between Novartis Pharma AG (“Novartis”) and GW Pharma Ltd. (“GW Pharma”) as per provision of Article 6 (Pharmacovigilance) of the Distribution and License Agreement dated 08th April 2011 between the parties (“the Master Agreement”). The parties do hereby agree as follows with respect to the exchange of safety data and information pertaining to Sativex® (“Product”), a pharmaceutical agent developed by GW Pharma and licensed to Novartis by GW Pharma for the territories set forth in the Master Agreement (“Novartis Territory”).

The parties understand that the purpose of this PV Agreement is not to add to, reduce or otherwise modify the rights or obligations of either party under the Master Agreement but to further define their respective roles, as originally outlined in the Master Agreement in respect of the subject matter hereof. Both parties shall comply with applicable ICH guidelines and national regulatory requirements in their respective territories.

This PV Agreement shall become effective immediately on the PV Agreement Date of last signature and remain effective 6 (six) months beyond the termination of Master Agreement or until all stock in the Novartis Territory has expired, or an alternative agreed arrangement for Pharmacovigilance in the Territory has been established.

1.2 Language

The parties agree to communicate with each other and to prepare, in English, the documents required to be exchanged between the parties by this PV Agreement.

1.3 Definition of Terms

For the purposes of this PV Agreement, capitalised terms used and not otherwise defined herein shall have the meaning assigned to the equivalent term used in the Master Agreement. The parties agree to apply International Conference on Harmonisation (ICH) and country-specific regulatory promulgated definitions, as appropriate.

1.4 Correspondence Files

Without limiting the relevant rights and the obligations of the parties under the Master Agreement with respect to data ownership and exchange, each party shall keep on file, in its own manner a complete copy of all its PV-related correspondence with the other party pertaining to Product, for as long as Product is under investigation, for a minimum of 10 (ten) years, or as long as Product is authorised. In the event one party requests the other party to provide copies of such

correspondence, the other party shall cooperate with such request.

1.5 Expedited Reporting Responsibility To Competent Authorities

1.5.1 Clinical Studies

GW Pharma shall, during the term of this PV Agreement, report to the relevant regulatory authorities and the involved Ethics Committees, Suspected Unexpected Serious Adverse Reactions (SUSARs) and other potential safety related issues occurring during any clinical studies which use Product and are conducted in the GW Pharma Territory and sponsored by, or on behalf of, GW Pharma, its Affiliate and/or a sub-licensee in accordance with ICH E2A guidelines and the applicable national regulatory requirements of the country of GW Pharma Territory concerned, the provisions of this PV Agreement and the relevant provisions of the Master Agreement.

Where Novartis is the sponsor of a clinical study for Product, Novartis shall, during the term of this PV Agreement, report to the relevant regulatory authorities SUSARs and other potential safety related issues occurring during any clinical studies which use Product and are conducted in the Novartis Territory and sponsored by, or on behalf of, Novartis, its Affiliate and/or a Novartis sub-licensee in accordance with ICH E2A guideline and the applicable national regulatory requirements of the country of the Novartis Territory concerned, the provisions of this PV Agreement and the relevant provisions of the Master Agreement.

GW Pharma and Novartis shall, within the period of time required by this PV Agreement, report to the other party all SUSARs and other potential safety related issues which occur in their respective territories. The further obligations of the parties with respect to SUSARs and other potential safety related issues are contained in Appendix 3.

1.5.1.1 Handling of SUSARs

The sponsor of the study, whether GW Pharma or for a Novartis-sponsored study, in accordance with national regulatory requirements, Novartis shall be responsible for the appropriate submissions of SUSARs to the concerned regulatory authorities investigators, and the ECs, the concerned regulatory authorities in the countries where the study is taking place and in the other regulatory authorities in the Novartis Territory. Novartis shall forward such reports to GW for GW to report to the authorities in countries in the GW Territory where the study is not taking place.

For a GW Pharma-sponsored study, in accordance with national regulatory requirements, GW Pharma shall be responsible for the appropriate submissions of SUSARs to the investigators, the ECs, the concerned regulatory authorities in the countries where the study is taking place and in the other regulatory authorities in the GW Pharma Territory. GW Pharma shall forward such reports to Novartis for Novartis to report to the authorities in countries in the Novartis Territory

where the study is not taking place. In order for GW Pharma to be able to fulfil its global pharmacovigilance responsibilities and regulatory reporting obligations for a Novartis sponsored study, GW Pharma shall receive from Novartis before the start of each clinical study (and throughout the study in case of any change):

· An English copy of the protocol

· The reference safety information or IB for IMPs and comparator products, where relevant

· The list of planned/ongoing/completed studies and clinical study reports

1.5.1.2 Clinical Investigator Communications

GW Pharma and Novartis shall each be responsible for communicating any SUSARs and other potential safety related issues to their respective clinical investigators for Product (including the clinical investigators of their Affiliates and/or sub-licensees) when acting as the sponsor in their respective Territories in accordance with ICH guidelines, the relevant national legislation, provisions of any relevant study protocol and the provisions of this PV Agreement.

1.5.1.3 Annual Safety Reports (ASR)/Development Safety Update Reports (DSUR)

GW shall prepare and submit the DSUR in the EU, including data provided by Novartis. GW shall provide a detailed request for information to Novartis at least forty (40) calendar days prior to each Data Lock-Point, and Novartis shall provide the necessary information no later than five (5) calendar days after the Data Lock-Point. The final report shall be provided to Novartis allowing 7 calendar days for review/ comment.

The same report may be submitted by both companies, if required in Novartis territory.

Information foreseen for inclusion in the DSUR which GW shall confirm/update/complete in its request to Novartis 40 days prior to DLP shall include the following when relevant:

Interventional Ongoing Novartis-sponsored studies.

· Interventional Completed Novartis-sponsored studies during the review period, with study synopsis including Clinical study Report Conclusions.

· Estimated cumulative exposure from completed and ongoing interventional studies by investigational drug, comparator and placebo.

· Cumulative subject exposure to investigational drug from completed interventional trials by age and sex.

· Cumulative subject exposure to investigational drug from interventional trials by race.

· List of subjects who died during the reporting period with reason for death.

· List of subjects who dropped out of studies reporting period with reason for drop out.

· Significant protocol amendments or other actions due to safety or efficacy reasons.

· Any new study safety results with potential impact on risk-benefit profile.

· Marketing exposure information for review period and cumulatively including Novartis Marketing Authorisation status.

· Safety information from non-interventional studies.

· Separate DSURs that have been completed for investigational drug e.g. that has been submitted by a third party, or where the drug is used in combination product or different indication.

Submission dates of the DSUR should be harmonised to the IBD of Product where possible.

1.5.2 Commercial Product Use and Spontaneous AE/SAE reports

Novartis shall be responsible for reporting any AE/SAEs and other potential safety related issues pertaining to Product to the regulatory authorities in the Novartis Territories in accordance with ICH guidelines and national regulatory requirements. Likewise, GW Pharma shall be responsible for reporting any AE/SAEs and other potential safety related issues pertaining to Product to the regulatory authorities in the GW Pharma Territory in accordance with ICH guidelines and national regulatory requirements. Novartis and GW Pharma shall, within the period of time required by this PV Agreement, exchange reports of AE/SAEs as specified in this PV Agreement and occurring in their respective territory and brought to its knowledge with the other party and such other party shall be responsible for reporting such AE/SAEs to the relevant regulatory authorities requiring such report. The further obligations of the parties with respect to exchange of AE/SAEs with commercial use of Product and spontaneous reports are contained in Appendix 3.

1.5.3 Literature

GW Pharma shall be responsible for screening at least weekly the published world-wide scientific and medical literature for safety data analysis using GW Pharma defined search strings. Novartis shall be responsible for screening local scientific and medical literature published in Novartis Territories according to Novartis SOPs. Published case reports shall be processed, exchanged as described in Appendix 3 and submitted to the regulatory authorities as required by the applicable national regulatory requirements. If the original article is not in English, a translation shall be provided as a follow-up report and the timeline for exchange of the translated article will be in accordance with the timelines stated in Appendix 3, with the clock starting upon

receipt of the translated article by the sending Party.

1.5.4 Quality Complaints and Product Recalls

Adverse Events associated with a quality complaint shall be communicated to the Pharmacovigilance Department of the Party receiving the case, according to that Party’s SOP, and exchanged according to this Pharmacovigilance Agreement. Product quality complaints and product recalls shall be handled according to a separate Quality Assurance Agreement.

1.5.5 Pharmacovigilance Database

GW Pharma shall be responsible for maintaining a single worldwide pharmacovigilance database of Product.

1.5.6 EU Qualified Person for Pharmacovigilance

GW will employ the EU Qualified Person for Pharmacovigilance (QPPV) and Deputy QPPV for the Product. Where a local national QPPV or any local regulatory special Pharmacovigilance representation is required a formal documentation of any delegated responsibilities will be made between both Parties when not covered by the Agreement.

1.5.7 Medical Information In Relation to Pharmacovigilance

For medical information, Novartis will follow the local regulations, their own Standard Operating Procedures (SOPs) and the Agreement requirements to manage any product related enquiries

· Novartis is responsible for responding to medical information enquiries from all sources (including any patient enquiries) and formulating suitable responses according to Novartis SOPs

· Novartis will provide these responses based upon the latest reference product information and GW’s list of standard questions and answers document.

· GW will provide Novartis with current and accurate responses approved by GW according to GW SOPs, to enquiries involving the use of Sativex where information enabling a response is not available within the current product information or GW’s list of standard questions and answers document. To maintain consistency in medical information routing, these replies will be escalated by Novartis within agreed timelines by both parties. In most cases (>90%), such requests to GW would be escalated by Novartis within 2 business days of receipt and GW will respond to the contact at Novartis as soon as possible but no later than 2 business days thereafter. For queries requiring immediate response, the expedited ad-hoc timeframe for response will be agreed between Novartis and GW, in most cases (>90%) within 24 hours. For queries requiring longer than 2 business days for GW to respond (<10%), a suitable timeframe for response will be agreed between Novartis and GW. Novartis will forward the final response to the enquirer.

· If needed, Novartis has the right to request from GW access to all relevant Sativex information (including unpublished data, internal data, or data on file) to assist in the preparation, review and approval of responses. In such cases, GW will aim to provide the data requested within 2 working days, or will agree with the requester the required timeframe. This may include but is not limited to contacting GW’s Pharmacovigilance Department (GWPVD) for specific tolerability or safety information to allow for the provision of a comprehensive response to an external enquiry. GW is responsible for providing the current and accurate information of the product in all cases.

· GW will ensure that the list of standard questions and answers document is updated periodically, at least once a year. For safety or regulatory related changes, GW will update the item(s) on the list and notify Novartis of the new information/changes without delay.

· If an AE/SAE or other safety issue is contained within a medical information enquiry this will be processed according to section 1.6.1 and Appendix 3.

1.5.8 PSURs/PADERs

1.5.8.1 PSUR

GW Pharma shall be responsible for preparing an international PSUR which may be adapted for submission to each regulatory authority in its territory in which GW Pharma is the MAH of Product and in accordance with the current ICH and applicable international guidelines. No later than 42 (forty-two) days after the data lock point a draft report shall be provided to Novartis for comments to be made within 5 (five) calendar days. No later than 5 (five) calendar days before the target submission date (Day 60 after data lock-point) a copy of the final PSUR shall be provided to Novartis. This may be used for submission by Novartis if needed. The periodicity of such PSURs shall be based upon the International Birth Date (IBD) for the Product and/or as requested by the Authorities. GW Pharma and Novartis will seek written authorisation from the regulator of their responsible territories to harmonise the PSUR/PADER reporting timelines with the IBD of Product as the Data Lock-Point. GW will also prepare PSUR addendum reports as needed by regulatory authorities and agreed with GW in advance by Novartis. Both parties will aim to keep the number of addendum reports to a minimum.

The PSUR will detail the risk-benefit situation with Product (dosage form and indication as required) in light of current information and with a historical review. Upon request in writing, each Party shall promptly provide the other with any relevant information required for the completion of PSURs (for example patient exposure estimates or sales figures, marketing authorisation status, information on targeted safety studies and MAH or Health Authority actions taken for safety reasons, national safety labeling deviations from the CDS). Such information should be requested before the data lock point for the PSUR (e.g. normally 60 days before submission due date).

The Party holding the Marketing Authorisation in a country shall be responsible for submitting PSURs and other periodic safety reports to the Regulatory Authority in that country according to the applicable laws, regulations and guidelines.

1.6 Safety Data Exchange

1.6.1 Method of Exchange

For individual case summary reports (ICSRs) on Product, each party agrees to provide the other party with a CIOMS I report form (as defined in Appendix 3). The CIOMS 1 Report form will reflect the source data comprehensively and accurately without interpretation of reported information. These will be transmitted via email, with facsimile or courier to be used only as a

contingency.

Source documents will be retained indefinitely by Novartis for all ICSRs. Source documents will be made available to GW upon request and in a reasonable timeframe.

All “Other Potential Safety Related Issues” and “Non-valid Reports” will also be subject to the same data exchange provision methods of exchange as described above. If it is not possible to present these types of safety data as a CIOMS I report form, the most applicable report format will be used.

Detailed information pertaining to the timelines for data exchange between the parties is described in Appendix 3.

1.6.2 Reconciliation of Reports

Quarterly, not later than thirty (30) days after the end of each calendar quarter, each party shall provide the other with a listing of all ICSRs exchanged and other potential safety related issues that were sent/received and entered into the global safety database, to enable each party to reconcile all reports received from the other party during the preceding calendar quarter, and to confirm that the safety data exchange process is functioning properly. Where discrepancies between the parties safety data are identified, each party agrees to inform the other party, to take reasonable steps to reconcile the data, and to take all reasonable actions to prevent reoccurrence.

If the number of ICSRs reported to Novartis monthly exceeds 100 cases, reconciliation frequency will be carried out monthly (thirty days after the end of the calendar month).

1.6.3 Dictionary

The MedDRA dictionary shall be used by both parties for coding all Safety Information that shall be exchanged in accordance with this PV Agreement. All regulatory reports should be coded using the latest version/preceding version of MedDRA current at the time that the report was received.

1.7 Signal Detection and Risk Management

GW Pharma shall primarily be responsible for signal detection, benefit-risk assessments and approve all risk minimisation activities of Product and Novartis shall additionally assist GW Pharma for such processes. GW Pharma will maintain safety surveillance activities for the Product globally. In the event that a potential or definite safety signal is identified, GW Pharma will respond appropriately and expediently, depending on the severity and significance of the signal.

The minimum requirements for signal detection shall include:

An ongoing review of single cases in the pharmacovigilance database) review and evaluation at a minimum of 3 time points in a year for detection of new or changing signals:

· aggregated case series in clinical trial and pharmacovigilance databases, , including cases with only reaction and product information

· scientific literature

· other safety sources as appropriate

GW Pharma is responsible for maintaining and the ownership of the Development Core Safety Information (DCSI) and the Company Core Safety Information (CCSI) for the Product. Any amendment to the CCSI would warrant changes to all labelling globally (unless expressly refused by a Regulatory Agency).

GW Pharma is responsible for maintaining an international Risk Management Plan (RMP) for Product (in accordance with ICH E2E). Where in consultation with regulatory authorities specific local risk minimisation plans (RiskMaps) are required within a GW Pharma or the Novartis Territories each party will notify the other to assess if the activity requires implementation in their respective territories. Both parties will collaborate to implement any RMP activities as required.

Assessment of such risk management processes will require review by all parties to ensure a consensus of opinion. In any disagreements the most conservative safety approach will be adopted.

The international RMP will detail all RiskMaps implemented by Territory.

GW Pharma will provide training and training materials to Novartis for the RMP initially following the signature of this agreement and upon any subsequent update to the RMP.

1.8 Updates to Core Safety Data Information and Product Label

Parties shall use a joint Company Core Safety Information (CCSI) prepared and maintained by the GW. This document shall be reviewed and updated regularly by GW and reviewed at least at the time of each PSUR and following detection of any new signals. Each Party may propose changes to the Company Core Safety Information, communicating these to the other Party, who shall provide feedback or comments within 5 calendar days. Any proposed changes shall be agreed upon prior to implementation. Where no agreement can be reached, the issue shall be escalated for resolution to the appropriate joint committee. Failing this, the Parties shall agree to adopt the most conservative approach from a safety perspective.

Each Party shall base the national labelling upon the CCSI as a minimum, each Party being independently responsible for the maintenance, amendments and updates of National Product

Information documents intended for Health Care Professionals, Regulatory Authorities and patients in their respective Territories. If any deviations are requested by the relevant Regulatory Authorities, such request should be communicated to the other Party. The Company response should be shared with the other Party and agreed upon prior to submission to the Regulatory Authorities. The outcome of the discussion with the Regulatory Authorities, including any deviation to the Company Core Safety Information should be communicated to the other Party.

GW Pharma shall inform Novartis of any change in its CCSI and CCDS including any new findings from any source which may affect the safety profile of the Product, or any regulatory instructions. For serious and significant safety issues, these will be communicated immediately upon identification and the CCDS document must be updated and provided to Novartis within 10 calendar days from issuance of the revised CCSI. For non-serious significant safety issues, the CCDS must be updated and notified to Novartis within 25 calendar days from issuance of the revised CCSI .

Novartis must inform GW Pharma of the amendment to the labels used in Novartis Territories as a result of the CCSI change. Each Party shall ensure that safety information provided on external websites it sponsors is maintained current at all times.

For clinical studies sponsored by Novartis, whenever possible, an Investigator’s Brochure with a common core safety information section obtained from GW will be used.

1.9 Requests from Regulatory Authorities

Requests to address an issue regarding the safety of Product received from a regulatory authority shall be exchanged between the parties.

Each party agrees to keep the other party informed, commencing immediately of notification of any action by, or notification or other information which it receives (directly or indirectly) from any Regulatory Authority, which: (a) raises any material concerns regarding the safety or efficacy of Product; (b) which indicates or suggests a potential material liability for either party to third parties arising in connection with Product; or (c) which is reasonably, likely to lead to a recall of Product, including in all cases, but not limited to:

· regulatory Authority inspections of manufacturing, distribution or other related facilities, in which Product is manufactured, stored or otherwise present;

· receipt of a warning letter from any Regulatory Authority relating to Product; or

· initiation of any Regulatory Authority investigations, detention, seizure or injunction

concerning Product.

GW Pharma shall prepare the response for queries originating from its GW Pharma Territory. Novartis shall prepare the response for queries originating from the Novartis Territory. Prior to submission to a regulatory authority, the party shall send a draft copy of its proposed response to the other party for review and comments within an agreed timeframe.

If requested to do so, GW shall assist Novartis to respond to questions or requests for information by Regulatory Authorities by promptly providing data from the global safety database.

Each Party shall copy to the other all significant Regulatory Authority communications regarding safety information for the Product.

1.10 Audits

Each party reserves the right, with reasonable advance notice and agreed upon audit plan/scope, to conduct audits of the other party’s pharmacovigilance procedures in order to evaluate compliance with provisions outlined in this PV Agreement. Reasonable notice will constitute at least 6 weeks of notice to be provided before the requested audit date. An audit will not be conducted more than once a year unless serious compliance issues have been identified in previous audits or major changes in business practice (safety) have occurred within the organisation. Questionnaires may be used when deemed appropriate in advance of, or in replacement of, a scheduled audit.

Each party, and its employees and representatives, shall cooperate with any such activities and shall ensure timely access to requested facilities and documentation. Any audit findings that may affect the other party will be mutually shared.

Any audit request shall be addressed in writing to the Head of Global Pharmacovigilance, Pharmacovigilance Department, as noted Part II, Section 1.1 of this PV Agreement.

1.11 Dispute Resolution

In the case of a dispute, every effort should be made to resolve the issues and take the most conservative approach, however, if resolution cannot be reached between the two parties then the dispute should be referred to the Joint Steering Committee (as defined in the Master Agreement) as it necessitates.

1.12 Confidentiality

Each party agrees that all information provided by the other party will be regarded as proprietary and confidential. Safety information may be passed to third parties (Regulatory Authorities and

health professionals) when deemed appropriate. Patient confidentiality will always be maintained.

1.13 Business Continuity

Each party shall adhere to a strict business continuity in particular in case of incidents such as pandemia which may influence the personnel capacity as well as key business processes. Both parties shall use their best efforts to prevent any disruption or discontinuity of reporting and notification duties according to this agreement. The parties shall implement a business continuity plan which maximises the compliance with all applicable regulatory and contractual provisions, including if necessary an adequate prioritisation process which considers the seriousness of the reportable adverse events and provision of information required to write a PSUR or ASR/DSUR, if scheduled.

1.14 Critical Issues

Any Safety related issue deemed to be of a critical nature by either party will instigate an immediate meeting of members of the Critical Issue Management Team (Appendix 5).

Part 2. Execution of Agreement

This PV Agreement shall come into force and effect as of the PV Agreement Date of last signature and shall remain in force for 6 months beyond the term of the Master Agreement for as long as it applies in any country of the Novartis Territory. Any provision of this PV Agreement or the Master Agreement which is expressly indicated to survive termination or expiration shall continue to be binding on the parties.

2.1 Amendments to Agreement

Amendments to the Pharmacovigilance Agreement are by mutual consent and should be undertaken immediately when either party is aware of any change in national or international safety reporting requirements which impacts upon the language and content of this document, including any changes in business practice which may cause revision to timelines as specified in the agreement.

Other amendments to personnel contact details should also be changed immediately. It is the responsibility of the respective parties to inform each other of any personnel or reporting details within one business day so that the appropriate contacts can be amended.

Any amendment to this PV Agreement shall be made in writing, signed by both parties and clearly indicate that the parties intended to vary the terms hereof. This PV Agreement shall be reviewed when either party identifies the potential need to revise/modify this PV Agreement or

at least once every two years and each party shall provide the other party with any proposed revisions to this PV Agreement including its appendices. This PV Agreement is version controlled and any changes or renewal of the agreement will warrant change in the version number.

2.1.1 Notices

Except as may be otherwise provided in this PV Agreement, any notice, consent or other communication required or permitted to be given under or in connection with this PV Agreement shall be deemed to have been sufficiently given if in writing and personally delivered by messenger or sent by internationally recognised express courier service, prepaid, to the party for which such notice is intended, at the address set forth for such party below:

(a) ***		(b) ***
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or to such other address for such party as it shall have specified by like notice to the other party, provided that notices of a change of address shall be effective only upon receipt thereof. If sent by messenger or express courier service, the date of receipt (in the case of personal delivery) shall be deemed to be the date on which such notice or other communication has been given.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Part 3. Appendices

This PV Agreement includes appendices that are all hereby incorporated herein and made a part of this PV Agreement by this reference. The appendices are listed below:

Appendix 1: Definition of Terms

Appendix 2: Causality Definitions Used by Novartis for Product

Appendix 2A: Causality Definitions Used by GW Pharma

Appendix 3: Method of Safety Data Exchange

Appendix 4: Routine Pharmacovigilance Contact List for Data Exchange and Queries

Part 4. Signatories

These procedures for the exchange of pharmacovigilance data between GW Pharma and Novartis regarding Product have been agreed to and adopted by both parties.

IN WITNESS WHEREOF, the parties have executed this PV Agreement by their duly authorised representatives as the date first written above.

	NOVARTIS PHARMA AG			GW PHARMA LTD.


By	/s/ Philippe Close		By	/s/ Stephen Wright
	Philippe Close Chief Safety Officer and EU-QPPV, Drug Safety and Epidemiology Novartis Pharma AG			Stephen Wright Research and Development Director, EU Pharmacovigilance Qualified Person

	Date:	16 th February 2012		Date:	28 th FEB 2012


	NOVARTIS PHARMA AG. GW PHARMA LTD.


By	/s/ (Dr. DJ Lewis)
	Gervais Tougas Global Head Drug Safety and Epidemiology, Novartis Pharma AG

	Date:	16 th February 2012

Appendix 1. Definition of Terms

The definitions of the following terms are based on CIOMS working groups IV-VII, ICH E6(R1), ICH-E2A, ICH-E2D and Volume 9A (Revision September 2008)

1. “ADR” shall mean Adverse Drug Reaction. In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. For authorised products, adverse drug reactions, as established by regional regulations, guidance, and practices, concern noxious and unintended responses to a medicinal product. All adverse reactions, in contrast to an adverse event, are characterized by the fact that a causal relationship between the medicinal product and the occurrence is at least suspected. Adverse reactions also include clinical consequences associated with the use of the product outside the terms of the SPC. For regulatory reporting purposes, if an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction.

2. “AE” shall mean Adverse Event, any untoward medicinal occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

3. “Abuse” shall mean persistent or sporadic, intentional excessive use of medicinal products which is accompanied by harmful or psychological effects.

4. “Affiliate” shall have the meaning assigned to it in the “Master Agreement”.

5. “ASR/DSUR” shall mean Annual Safety Report/Development Safety Update Report, a document containing a global evaluation on safety of the IMP and its impact to the subject’s safety which is required annually by the CAs and lead ECs in EU.

6. “Benefit-risk balance” Shall mean an evaluation of the overall therapeutic effects of the medicinal product in relation to the risks (any risk relating to the quality, safety and efficacy of the product as regards patients or public health).

7. “CA” shall mean Competent Authority(ies).

8. “CCDS” shall mean Company Core Data Sheet, a document prepared by GW Pharma. This document is a summary of the key characteristics of the product. It includes, in addition to pharmacovigilance data relating to the product globally, information on indications, dose, pharmacology, and other characteristics. The CCDS is not intended to incorporate all National variations in safety data, but all local SPCs should contain the CCDS.

9. “CCSI” shall mean Company Core Safety Information, all relevant safety information contained in the CCDS prepared by the global safety database holder (GW Pharma) and which the MAH requires to be included in the SPC/label text in all countries where the medicinal product is authorised, except when the local CA/RA specifically requires a modification. It is the reference information by which listedness and unlistedness are determined for the purpose of periodic reporting for authorised MPs, but not by which expectedness and unexpectedness are determined for expedited reporting.

10. “CIOMS” shall mean the Council for International Organisations of Medical Sciences.

11. “CIOMS I Form” shall mean a report form recommended by CIOMS I guidelines to be used for communicating an individual case safety report to RAs, ECs, etc. Many RAs also have local report forms. It is commonly used for non-electronic reporting in international studies and spontaneous reporting.

12. “Company Receipt Date” shall mean the first date when an employee of Novartis, of GW Pharma, or of a CRO, providing services to these first becomes aware of a Safety Report. Receipt date according to ICH E2D = Day 0 (see below).

13. “Consumer” shall mean a person who is not a health care professional including patient, lawyer, friend or relative/parents/children of a patient.

14. “Critical Issue” Any significant potential or identified safety matter related to Product which is an urgent safety issue; a quality related problem; or an issue of public relations.

15. “CRO” shall mean Contract Research Organisation.

16. “Data Lock-Point (cut-off date)” shall mean the date designated as the cut-off date for the data to be included in a periodic safety document such as PSUR, PADER or ASR/DSUR.

17. “Day 0” shall mean the day when any personnel of GW Pharma, Novartis, their affiliate, their partner company or CRO providing services to them first receives a case report.

18. “EC” shall mean Ethics Committee.

19. “EU” shall mean European Union.

20. “E2A” is the ICH guideline on Clinical Safety Data Management: Definitions and Standards for Expedited Reporting of adverse drug reactions in the investigational phase of drug development.

21. “E2B(R2)” is a revision of the ICH guideline on clinical safety data management: data elements for transmission of individual case safety reports (ICSR(s)).

22. “E2C(R1)” is the tripartite harmonised ICH guideline on the format and content of safety updates, which need to be provided at intervals to regulatory authorities after products have been marketed. E2C(R1) means the addendum to E2C on Periodic Safety Update Reports for marketed drugs (PSURs), and is always used in conjunction with E2C.

23. “E2D” is the tripartite harmonised ICH guideline on a standardised procedure for Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting to relevant authority. The definitions of the terms and concept specific to post-approval phase are also provided. E2A definitions in clinical safety data management was maintained in this document as post-approval safety data management, such as seriousness definition.

24. “E2E” is the ICH guideline on Pharmacovigilance Planning

25. “Volume 9A” is the rules governing medicinal products in the European Union. Guidelines on pharmacovigilance for medicinal products for human use

26. “FDA” shall mean the United States Food and Drug Administration.

27. “Global Pharmacovigilance Database” shall mean a worldwide, comprehensive, validated safety data management system owned by GW Pharma, based on a specific software providing defined functionalities with remote, controlled (restricted) access for entering, maintaining, processing, sorting, storing and retrieving the data, with an audit-trail.

28. “GW Pharma Territory” shall mean countries other than “Territory” set forth in the “Master Agreement”.

29. “Health Care Professional” would be described as a medically qualified doctor, dentist, pharmacist, nurse, radiographer or coroner.

Although the emphasis is for medically qualified reports to be sought, where products reports from patients, relatives, lawyers, the media and Internet need to be collected and sent according to the minimum criteria for reporting where the reporter is a non-health care professional.

30. “IB” shall mean Investigator’s Brochure.

31. “ICH” shall mean International Conference on Harmonisation (of Technical Requirements for Registration of Pharmaceuticals for Human Use).

32. “IMP” shall mean Investigational Medicinal Product.

33. “International Birth Date (IBD)” shall mean the date of the first marketing authorisation for an MP granted to the MAH in any country in the world. For Product this is the 15 April 2005 (Canada).

34. “Lack of Efficacy” An effect which is less than the expected action of the Product as determined in clinical studies.

35. “Listed ADR” shall mean an adverse reaction whose nature, severity, specificity and outcome are consistent with the information in the CCSI.

36. “MAH” shall mean a Marketing Authorisation Holder.

37. “Master Agreement” shall mean the Development and License Agreement made and entered into as of 08 April 2011 between GW Pharma and Novartis.

38. “MedDRA” shall mean Medical Dictionary for Regulatory Activities. This is a coding system for medical data that is intended for international adoption. It is designed to support the classification, retrieval, presentation and communication of medical information throughout the medical product regulatory/life cycle.

39. “Medicinal Product (MP)” shall mean any substance or combination of substances presented as having properties for treating or preventing disease in human beings.

40. “Non-Interventional Study” shall mean post-authorised non-interventional clinical investigations in humans where the assignment of a subject to a therapeutic strategy is not decided in advance by a protocol and the medicinal product is prescribed in the usual manner in accordance with the terms of the marketing authorisation.

41. “Non-Serious Adverse Event” shall mean an event that does not meet the definition of a serious defined in the ICHE2A and ICH E2D guidelines, and relevant local regulatory requirements.

42. “Other Potential Safety Related Issues” & “Non-valid Reports

· All spontaneously reported AEs/ADRs associated with Product (including approved, unapproved indications, drug-drug interactions, pregnancy and any cases of overdose/abuse/misuse or lack of efficacy).

· All information required for the compilation of Periodic Safety Update Reports (PSURs) including pregnancy data (accidental exposure) irrespective of any reported foetal

abnormalities.

· Scientific literature reports, consumer reports, post-marketing studies, clinical study data as produced.

· All other information as produced by or required by Regulatory Authorities worldwide. This includes any active surveillance responsibilities as may be required by any regulatory agency on a case-by-case basis (e.g. target safety monitoring in hospitals and health facilities).

· Abuse (use for non-clinical reasons) with or without an AE.

· Withdrawal symptoms

· Inadvertent or accidental exposure, with or without an AE.

· An unexpected therapeutic or clinical benefit from use of Product.

· A case involving exposure during pregnancy or lactation Product (paternal/maternal).

· Overdose, with or without an AE. The overdose can be deliberate or accidental in order to be reported.

· Medication errors with or without an AE.

· Lack of efficacy reports.

· Cases with at least product and reaction information.

· Events related to Product Technical Complaints.

· AEs deemed at any time to be of special interest.

· Any transmission of infectious disease via medication

· A Non-valid report is any case that has and adverse event and Product

43. “Novartis Territory” shall mean territory set forth in the “Master Agreement” as “Territory”. These territories are as follows:

Australia, Fiji, New Zealand.

Part A -Africa Region: Algeria, Angola, Benin, Botswana, Burkina Faso, Burundi, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Democratic Republic Of The Congo, Republic Of The Cote D’lvoire, Djibouti, Egypt, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, The Ghana, Guinea, Guinea-Bissau, Kenya, Lesotho,

Liberia, Libya, Madagascar, Malawi, Mali, Mauritania, Mauritius, Mayottte, Morocco, Mozambique, Namibia, Niger , Nigeria, Rwanda, Saint Helena, Ascension & Tristan Da Cunha, Sao Tome & Principe, Senegal, Seychelles, Sierra Leone, Somalia, South Africa, Sudan, Swaziland, Tanzania, Togo, Tunisia, Uganda, Western Sahara, Zambia, Zimbabwe.

Part B -Asia Region: Afghanistan, Bangladesh, Bhutan, British Indian Ocean Territory, Brunei, Burma, Cambodia, India, Indonesia, Korea, North Korea, South Laos, Malaysia, Maldives, Nepal, Pakistan, Papua New Guinea, Paracel Islands, Philippines, Singapore, Spratly Islands, Sri Lanka, Taiwan, Thailand, Timor-Leste, Vietnam.

Part C -Middle East Region: Armenia, Azerbaijan, Bahrain, Belarus, Georgia, Kazakhstan, Kryrgyzstan, Iran, Iraq, Jordan, Kuwait, Lebanon, Oman, Mongolia, Qatar, Saudi Arabia, Syria, Tajikistan, United Arab Emirates, Turkmenistan, Uzbekistan, Yemen.

44. “Overdose” Overdose is defined as a dose higher than that prescribed by a healthcare professional for clinical reasons, or higher than the maximum dosage stated in the prescribing information for the local data sheet.

45. “PADER” shall mean Periodic Adverse Drug Experience Report.

46. “PI” shall mean Package Insert.

47. “Product” shall mean Sativex®, a human pharmaceutical product developed by GW Pharma, containing delta-9-tetrahydrocannabinol 27mg/m1 (from Tetranabinex® - Cannabis sativa L. extract) and cannabidiol 25mg/m1 (from Nabidiolex® - Cannabis sativa L. extract)

48. “PSUR” shall mean the Periodic Safety Update Report, a document required by the RAs summarising safety information on an authorised MP collected during a defined period of time, plus certain accumulated safety information, and written according to the ICH E2C(R1) guidelines.

49. “PV Agreement” shall mean this Pharmacovigilance Agreement as amended under version control by the parties.

50. “RA” shall mean Regulatory Authority.

51. “Relationship to Drug” shall mean that a relationship to the medicinal product exists for an AE if there is a reasonable possibility that the AE may have been caused by the product.

52. “Reportable Adverse Reactions - Minimum Information”

A reportable adverse drug reaction (ADR) requires following minimum information:

a) an identifiable reporter -

An identifiable reporter is a healthcare professional i.e. a physician, dentist, pharmacist,

nurse, coroner, or a consumer including a patient, lawyer, friend or relative/parents/children of a patient, who can be identified by either name or initials, or address or qualification. ).

b) an identifiable patient - The patient can be identified by initials or patient number, age, date of birth or sex. The information shall be as complete as possible.

c) a suspect (I)MP

d) At least one adverse reaction

53. “RSI” shall mean Reference Safety Information

54. “Safety Information” shall have the meaning assigned as per definition no. 43.

55. “SAE/SADR” shall mean Serious Adverse Event/Serious Adverse Drug Reaction, an adverse drug experience/event/reaction occurring at any dose which

a) results in death,

b) is life-threatening,

*Life-threatening refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if more severe.

c) requires inpatient hospitalisation or prolongation of existing hospitalisation;

d) results in persistent or significant disability/incapacity;

e) is a congenital anomaly/birth defect;

f) an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalisation but, based on appropriate medical and scientific judgment, may jeopardise the patient/subject or may require intervention (e.g.. medical and/or surgical) to prevent one of the other outcomes listed in the definition above.) Examples of such include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias; or convulsions that do not result in hospitalisation, or development of drug dependency or drug abuse. Any suspected transmission via a medicinal product of an infectious agent is also considered a serious adverse reaction. A common Medically Important List will be adopted by both companies for medical events which should be considered as serious.

56. “Signal” shall mean a report or reports of an event with an unknown causal relationship to treatment that is recognised as worthy of further exploration and continued surveillance. Typically a signal is a previously unidentified ADR or Drug Interaction not previously mentioned in the CCDS, SPC, which has potential safety implications. Signals will be

observed against known risk benefit to determine if the new ADR influences existing receptions of the risk benefit.

57. “Solicited reports” shall mean safety reports from post-marketing organised data collection systems including non-interventional studies, post-authorisation named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, collection of information on efficacy or patient compliance. Such solicited reports shall be handled in accordance with spontaneous reporting timelines and processes.

58. “SOP” shall mean Standard Operating Procedure.

59. “SPC” shall mean Summary of Product Characteristics, the locally approved product information and the reference document against which expectedness is assessed for expedited reporting.

60. “Sponsor” in accordance with ICH E6(R1) and Volume 9A, is an individual, company, institution (or organisation) which takes responsibility for the initiation, management and/or financing of a clinical study.

61. “SUSAR” shall mean Suspected Unexpected Serious Adverse Reaction.

62. “Study” shall mean all clinical investigations in humans at the pre-authorisation stage in which the assignment of the subject to a particular therapeutic strategy is decided in advance by a protocol as a requirement of the applicable regulation. At the post-authorisation stage, clinical investigations in humans where the assignment of the subject to a particular therapeutic strategy is decided in advance by a protocol are interventional and shall be regarded as studies.

63. “Unexpected Adverse Event / Adverse Drug Reaction” shall mean an AE/ADR the nature, severity, or outcome of which is not consistent with the information in the reference safety information (e.g. current IB or SPC, PI or the approved labeling of the (I)MP).

64. “Unlisted Adverse Drug Reaction” shall mean a suspected ADR that is not specifically included as an ADR in the CCSI. This includes ADRs for which the nature, severity, specificity or outcome is not consistent with the information in the CCSI. It also includes class-related reactions which are mentioned in the CCSI, but which are not specifically described as occurring with the (I)MP.

Appendix 2. Causality Definitions Used by Novartis for Product

Related (Suspected)		All events with a reporter causality of related to Product. All cases will be treated as related for processing where causality is missing.*

Not Related		All events with a reporter causality that explicitly states no causal relationship to Product. Novartis also map unlikely to “Not suspected”

(Not suspected)

*Note: In the GW Global Pharmacovigilance Database, classification of “Related” and “Unrelated” are used for causality assessment. Causality assessment of “certain”, “probable”, “possible”, and “unlikely” by a reporter is mapped to “Related”.

Appendix 2A Causality Definitions Used by GW Pharma for Product

In the commercial / spontaneous situation all reports received are regarded as product related unless specifically stated otherwise. GW Pharma still reserves the right to upgrade the causality to related, but not downgrade the causality from related to not related.

For clinical studies, the Investigator should provide a causality assessment; if a causality assessment is missing then the assumed causality will be related. GW Pharma still reserves the right to upgrade the causality to related, but not downgrade the causality from related to not related. Only the terms of “Related” and “Not Related” are used to describe causality, applicable to both commercial/spontaneous and Clinical Study events.

Appendix 3. Method of Safety Data Exchange

On signing of this PV Agreement, GW will provide all prospective product SUSARs and spontaneous SADRS (as per sections 1.3, 1.4, 1.6 and 2.2) to Novartis via secure e-mail. Where either party undertakes investigational studies (Phases I, II, III and IV) for Product and becomes the sponsor for a study, or upon the submission of the first Marketing Authorisation Application (MAA) for Product in the Novartis Territory, commencing from the date of the sponsored study approval/ MAA submission, GW and Novartis will provide the prospective safety information to the other party as specified in sections 1 and 2 of this Appendix 3 respectively. Any information originating from Investigator Initiated studies will also be forwarded to GW by Novartis.

Each party shall evaluate the Safety Information reported in their respective territories from clinical studies (sponsored either by company or investigator initiated) or from commercial/spontaneous use as per existing company standard operating procedures in their respective territories. Expedited exchange between the parties shall apply only to Safety Information as defined below, unless otherwise requested by a regulatory authority.

If necessary, discussion between both parties shall be conducted within the defined timelines regarding case specific issues and a final consensus reached on individual case reports shall be confirmed via email. In the event of a discrepancy in the assessment of the reportability of a SUSAR or SADR, the more conservative approach should be taken and the case shall be reported in the Territories of both parties as needed. Each company reserves the right to follow their own SOPs for reportability assessment and submission to competent authorities.

Novartis will be responsible for collecting follow up information to any ICSRs originating in their territory and will make all reasonable attempts to do so. If additional information is outstanding follow-up will be performed for all reports for a minimum of two attempts or until acceptable resolution is reached. GW Pharma will also request follow up information as required through Novartis. Novartis will be responsible for obtaining the follow-up information from the reporting sources as requested by GW Pharma for cases originating in their Territory. GW Pharmacovigilance will then assess the case including a full medical review and further attempts for obtaining follow-up information may be required or the case may be closed as relevant. GW will contact Novartis for follow-up to any pregnancies as required.

Follow up information is intended to provide an accurate and comprehensive description of the safety information. Any changes relating to the patient details should also be collected where relevant. Follow up information should also include critical data as presented in medical records (outcome, laboratory data, autopsy report, discharge summaries). Other important information concerning concomitant medications, indication for use of suspect drug, relevant medical history, risk factors should all be obtained.

1.0 Clinical Studies

When in any clinical study using Product that it sponsors, either party receives a report of an SAE and if the details obtained for that SAE meets the minimum information (an identifiable patient, a suspect medicinal product, an identifiable reporting source, and at least one event or outcome that can be identified as serious), the party shall report the SAE to the other party as defined below in sections 1.1 to 1.6. This will consist a copy of a CIOMS I report farm as a PDF and if possible an xml file format electronic export of the case that is E2B compliant by secure electronic mail and using passwords. Day 0 being the day of obtaining the required minimum information SAE data.

1.1 Upon receipt of the initial/follow-up SAE in relation to Product, the party concerned shall report the event to the other party using the process and timelines stipulated in the following subsections.

1.2 An AE from clinical studies that is consistent with the definition of an SAE and occurs within the time period defined in the study protocol from the administration of the last dose of Product shall also be considered an SAE. Any AE that is consistent with the definition of an SAE and occurs outside the defined time period after the last dose of Product if associated with drug toxicity of Product shall also be considered an SAE.

1.3 Life-threatening / fatal SAEs from clinical studies that are causally related to Product or have a missing causality assessment shall be sent to the other party within 4 calendar days of Company Receipt Date , including as a minimum the CIOMS I Report Form. Any follow-up information pertaining to a life-threatening or fatal SUSAR case that does not change the seriousness status of report shall be sent as per section 1.4.

1.4 All SAEs other than life-threatening/fatal cases that are causally related to Product or have a missing causality assessment shall be sent to the other party within 8 calendar days of Company Receipt Date. All other SAEs that are not causally related to Product shall be sent to GW Pharma from Novartis within 30 calendar days of Company Receipt Date.

1.5 Each party shall promptly review all information concerning other potential safety related issues, including any potential signals that it has obtained or otherwise received from any clinical source. Hence, each party shall communicate to the other party within 8 calendar days of the reporting party’s receipt, such Safety Information which is likely to be important in the assessment of safety. If necessary, discussion between both parties shall be performed within required regulatory timelines, and a final consensus reached on individual cases shall be confirmed via email.

1.6 Novartis shall report any pregnancy cases, including partners of patients who become pregnant, to GW with 30 calendar days of the Company Receipt Date.

1.7 Each party is obliged prospectively to instruct investigators involved in company-sponsored clinical studies using Product to immediately report SAEs to the party either directly or as arranged with CRO. This instruction shall be a part of the contractual agreement between the sponsoring party and the investigator or CRO conducting the clinical studies.

2.0 Commercial Use I Spontaneous ICSRs

On and after the PV Agreement Date, when either party receives a report of an AE/ADR with the commercial/spontaneous use of Product (including any from non-interventional post authorisation safety studies), such party shall report the AE/ADR to the other party using the same method of transfer as described in Section 1 above and in accordance with the following:

2.1 Upon receipt of the initial/follow-up ADR which meets the minimum information to be considered as reportable for a case, the party concerned shall report the event to the other party.

2.2 Any fatal or life threatening report of a serious ADR shall be sent to the other party within 4 calendar days of Company Receipt Date. To the degree that it is feasible, the parties shall make efforts to obtain follow-up information and transmit it to the other party in the same time frame

2.3 Any other non-fatal or life threatening or follow-up to such reports of a serious ADR shall be sent to the other party within 8 calendar days of Company Receipt Date. To the degree that it is feasible, the parties shall make efforts to obtain follow-up information and transmit it to the other party in the same time frame.

2.4 Novartis shall send to GW all serious adverse events that are not deemed by the reporter to be causally related within 8 calendar days of company receipt.

2.5 For any report that is judged to be non-serious (regardless of causal relationship), Novartis shall send to GW Pharma within 30 calendar days of Company Receipt Date, the non-serious ICSRs. GW shall provide to Novartis a line listing of all non-serious ADRs from the Global safety database upon request.

2.6 Each party shall promptly review all information concerning other potential safety related issues, including any potential signals that it has obtained or otherwise received from any commercial and spontaneous sources. Hence, each party shall communicate to the other party within 8 calendar days of the reporting party’s receipt, such information which is likely to be important in the assessment of safety. Discussion between both parties shall be performed within required regulatory timelines, and a final consensus reached on individual cases shall be confirmed via email.

2.7 Literature Reports

Each party shall handle literature reports in a manner similar to that described for reports of SADRs and non-serious ADRs from commercial/spontaneous use. Reportable cases from a literature survey in a Novartis Territory shall be sent with a citation and summary in English via electronic mail in PDF format. Likewise GW Pharma shall send to Novartis literature articles from reportable cases via electronic mail in PDF format with a citation and summary in English, if the original literature is written in other than English. The Company Receipt date will be the date of receipt of the article/citation, and translations will be classed as follow-up information.

3.0 Safety Related Critical Issues

Any safety related issues deemed to be of a critical nature and falling outside of routine pharmacovigilance will be communicated to the other party without undue delay. All critical issues will be notified to the Joint Steering Committee (JSC) as per the Master Agreement. The Head of the Pharmacovigilance Department from each party will be notified at the same time as the JSC, unless they are already members of the JSC.

Appendix 4. Routine Pharmacovigilance Contact List for Data Exchange and Queries

NOVARTIS SAFETY CONTACTS:		GW SAFETY CONTACTS:
(a) *: *		(b) *: *

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EXHIBIT B

Agreed form QA Agreement

QUALITY AGREEMENT

ON MANUFACTURING, PACKAGING AND TESTING

between

Novartis Pharma AG

Lichtstrasse 35, 4056 Basel, Switzerland

and

GW Pharma Ltd

Porton Down Science Park

Salisbury

Wiltshire SP4 0JQ, United Kingdom

TABLE OF CONTENTS

1.	SUBCONTRACTORS GENERAL INFORMATION		5
	1.1.	Introduction	5
	1.2.	Scope of the Quality Agreement	5
	1.3.	Structure of the Quality Agreement	5
	1.4.	Amendment of the Quality Agreement	6

2.	QUALITY RESPONSIBILITY		6
	2.1.	Prevalence	6
	2.2.	Execution of responsibilities	6
	2.3.	Communication and Methods of Contact	6

3.	DIRECTIVES		6
	3.1.	General	6

4.	GENERAL QUALITY SYSTEMS		8
	4.1.	Qualification and Validation (Including Computer Systems)	8
	4.2.	Subcontracting	8
	4.3.	Data Integrity	8
	4.4.	Deviations, Corrective and Preventive Action Systems	9
	4.5.	Deviating Products	10
	4.6.	Waste	10
	4.7.	Counterfeiting	10
	4.8.	Complaints	10
	4.9.	Pharmacovigilance	11
	4.10.	Recalls	11
	4.11.	Influence on Quality by “Critical compounds”	12
	4.12.	Veterinary Products	12
	4.13.	Product Quality Review	12

5.	CHANGE CONTROL		12
	5.1.	General	12
	5.2.	GW’s proposed Major Changes	13
	5.3.	GW’s proposed Minor Changes	14
	5.4.	NOVARTIS proposed Changes	14

6.	STARTING MATERIAL		14
	6.1.	General Principles	14
	6.2.	Supplier Questionnaires	15
	6.3.	Supplier Audit	15
	6.4.	Procurement of Active Pharmaceutical Ingredient	15
	6.5.	Procurement of Non-Active Raw Starting Material	16
	6.6.	Starting Material Receipt, Testing Control, and Release	16
	6.7.	Storage	16
	6.8.	Measures Ensuring Supply Chain Integrity	17
	6.9.	Transport from Suppliers to GW	17

7.	PRODUCT MANUFACTURING		17
	7.1.	General Principals	17
	7.2.	Manufacturing, Packaging, Testing Documents and Specifications	18
	7.3.	Batch Manufacturing and Packaging Records	18
	7.4.	Sampling Plans	18
	7.5.	Reprocessing	18
	7.6.	Batch Certification	19
	7.7.	Warehousing	19

8.	QUALITY CONTROL (QC)		19
	8.1.	Quality Control Testing and Approval	19
	8.2.	Reference Standards	19
	8.3.	Out of Specification (OOS) Quality Control Testing Results	20

9.	ARTWORK		20
	9.1.	General	20

10.	RETENTION OF SAMPLES AND DOCUMENTATION		20
	10.1.	General	20

11.	RELEASE OF THE PRODUCT		22
	11.1.	Release for Shipment — “Technical Release” — Pre-requisites	22
	11.2.	Shipment under Quarantine	22
	11.3.	Release to the Market	22

12.	STORAGE		23
	12.1.	Storage and Packaging for Dispatch	23

13.	TRANSPORT IS PERFORMED BY NOVARTIS		23
	13.1.	Pick-up and Transport of Product from GW is performed by NOVARTIS	23
	13.2.	Air Freight	23
	13.3.	Road Freight	23

14.	PRODUCT RECEIPT BY NOVARTIS		24
	14.1.	General	24

15.	STABILITY TESTING		24
	15.1.	General	24

16.	COMPLIANCE AUDITS AND INSPECTIONS		24
	16.1.	Audits	24
	16.2.	Health Authority Inspections	25

17.	TERM AND EXPIRATION OF THE QA AGREEMENT		25

18.	DEFINITIONS		26

19.	SURVIVAL		26

20.	SIGNATURES		26

TABLE OF ANNEXES

ANNEX A: Contact Details

ANNEX B: Manufacturing and Testing Documents

ANNEX C: FUST and Samples Programmes

ANNEX D: Table of Responsibilities

ANNEX E: List of Approved Sub-Contractors

ANNEX F: History of Changes

1. SUBCONTRACTORS GENERAL INFORMATION

1.1. Introduction

1.1.1. Novartis Pharma AG is a company incorporated under the laws of Switzerland and having its registered office at Lichtstrasse 35, 4056 Basel, Switzerland (hereinafter “NOVARTIS”). NOVARTIS is an Affiliate of the Novartis Group of Companies (hereinafter “Novartis Group”) which is engaged in the manufacture, marketing and sales of pharmaceutical products and is the Contract Giver.

1.1.2. GW Pharma Ltd is a company incorporated under the laws of United Kingdom and having its registered office at Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ, (hereinafter “GW”) and is the Contract Acceptor.

1.1.3. GW holds a manufacturing licence (Manufacturer’s/ Importers Authorisation - MIA) issued by Medicines Healthcare products Regulatory Agency (UK).

1.1.4. GW has the knowledge, knowhow and detailed experience of the development, manufacturing and testing of the Product and NOVARTIS has purchased the rights to the Product Licences in certain territories.

1.1.5. NOVARTIS and GW are also referred to herein individually as a Party and jointly as the Parties.

1.1.6. NOVARTIS desires to entrust GW to perform services related to the manufacture of pharmaceutical Product(s) pursuant to the terms and conditions of this Quality Agreement and GW confirms being able to properly perform such activities.

1.1.7. The commercial arrangements relating to the manufacture of the Product(s) are governed under a separate Manufacturing and Supply Agreement entered into by and between NOVARTIS and GW.

1.2. Scope of the Quality Agreement

1.2.1. This Quality Agreement defines roles and allocates responsibilities between NOVARTIS and GW related to the Product(s) manufacturing, packaging and testing according to the intentions of European Commission (EU Pharmaceutical Legislation) and Pharmaceutical Inspection Convention (PIC/S) GMP directives and regulations.

1.2.2. In addition to these requirements, GW shall follow the corresponding national guidelines or regulations (such as the UK Statutory Instruments) prevailing at the time of manufacture.

1.3. Structure of the Quality Agreement

1.3.1. The Quality Agreement comprises the Core Document and Annexes. The Annexes to this Quality Agreement are an integral part of the Quality Agreement and are incorporated into this Quality Agreement by this reference. The Annexes may be signed by one quality responsible person per Party.

1.4. Amendment of the Quality Agreement

1.4.1. Changes or supplements to this Quality Agreement Core Document or Annexes can only be made by mutual consent in writing. Such amendments to the Quality Agreement shall be recorded in the Annex F, with each subsequent revision.

2. QUALITY RESPONSIBILITY

2.1. Prevalence

2.1.1. In the event of a conflict between this Quality Agreement and the Manufacturing and Supply Agreement, Manufacturing and Supply Agreement shall prevail, with respect to non-quality related terms, and this Quality Agreement shall govern with respect to all quality related terms. For the avoidance of doubt if any provisions of this Quality Agreement and/or the Supply Agreement are inconsistent with the terms of the GMP and/or other applicable regulations, such regulations prevail.

2.2. Execution of responsibilities

2.2.1. In the execution of their relevant responsibilities, both Parties agree to conduct the necessary reviews, approvals, rejections and consents in a timely manner and within the time limits specified. Where any Party requires the consent of the other, such consent shall not be unreasonably withheld or delayed.

2.2.2. In this Quality Agreement “approval”, “authorization” or “written communication” shall mean an statement on official letter head signed by the authoring Party’s responsible Quality Assurance representative.

2.3. Communication and Methods of Contact

2.3.1. Any communication related to this Quality Agreement between NOVARTIS and GW shall be exchanged in writing between the contact persons designated in Annex A. Transmission of such written documentation may be by mail or electronic system (i.e., fax, scan, email).

2.3.2. If the communication implies a change, the procedure under the chapter “Change Control” shall be followed. However, in the case of urgent notifications or transmissions, initial contact shall be made by telephone and followed thereafter by written documentation.

3. DIRECTIVES

3.1. General

3.1.1. GW is responsible that Products shall be manufactured, including primary packaging and quality control, in full compliance with GMP requirements, laws and regulations. The provisions of GW’s quality management system and standard operating procedures shall be applied and must be reflected in the individual operations.

3.1.2. The following general guidelines below are considered as standards for quality assurance.

Organisation		Document
EU Pharmaceutical Legislation		European Commission Directive 2001/83/EC

EU Pharmaceutical Legislation		European Commission Directive 2003/94/EC

EU Pharmaceutical Legislation		European Commission Directive 2011/62/EU (Falsified Medicines Directive)

EU GMP Guidance		The Rules Governing Medicinal Products in the European Union, Volume 4: EU Guidelines to Good Manufacturing Practice for Human and Veterinary Use

UK GMP Guidance		Rules and Guidance for Pharmaceutical Manufacturers and Distributors (current edition)

ICH		“Q” Quality Guidelines.

International Pharmaceutical Excipients Council (IPEC)		Good Manufacturing Practices Guide for Pharmaceutical Excipients 2006

EU Pharmaceutical Legislation		Guidelines on good distribution practice of medicinal products for human use (94/C 63/03)

Pharmaceutical Inspection Convention (PIC/S )		Guide to Good Manufacturing Practice for Medicinal Products (PE 009-8) or most recent version

European Commission - Note for Guidance		EMA/410/01 rev.3 (2011/C 73/01)
		Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products

3.1.3. The controlled substances have to be handled in full compliance with all applicable national and international requirements, laws and regulation.

4. GENERAL QUALITY SYSTEMS

4.1. Qualification and Validation (Including Computer Systems)

4.1.1. Processes: GW ensures that processes for cleaning, manufacturing, testing (in-process, quality control), packaging and warehousing are validated and carried out under GMP rules before starting any activity related to NOVARTIS Products. Validation reports shall be approved by GW. Approved validation protocols and reports shall be available for inspection by NOVARTIS.

4.1.2. Equipment: GW ensures that the manufacturing instructions and testing shall be followed using calibrated and qualified equipment. Qualification reports shall be approved by GW and shall be available for inspection by NOVARTIS.

4.1.3. Computer Systems: GW is responsible to ensure that computer systems used for operations in cleaning, manufacturing, testing (in-process, quality control), packaging and warehousing are validated. Approved validation protocols, reports, testing protocols, raw data and system operation procedures shall be available for inspection by NOVARTIS.

4.2. Subcontracting

4.2.1. GW agrees not to sub-contract any of the work related to Product to third parties other than those listed in Annex E without NOVARTIS’ prior written approval.

4.2.2. GW is required to establish QA-agreements with its sub-contractors. GW shall provide copies of relevant QA-agreements with its sub-contractors on request to NOVARITS during audit.

4.2.3. GW shall remain solely and fully responsible for the performance of the work by sub-contractors in accordance with the requirements set forth in this Quality Agreement. GW shall oblige its sub-contractors to inform GW on changes relevant to the registration of products, such as to the manufacturing location and procedures, to the equipment and materials used. Furthermore, on changes that could interfere with the quality of the products, and impact on the registration filing, such as to the testing procedures, instructions and specifications, GW shall inform NOVARTIS within five (5) business days after having received such information.

4.2.4. GW shall perform regular sub-contractor audits and evidence of audit on request to NOVARTIS.

4.3. Data Integrity

4.3.1. GW shall make all reasonable efforts to ensure that all data is accurate, controlled and safe from manipulation or loss, intentional or unintentional.

4.3.2. GW shall make all reasonable efforts to ensure that the procedures, the state of automation and/or management controls shall be in place and assessed to ensure complete data integrity.

4.3.3. GW shall make all reasonable efforts to ensure that documentation practices and data handling (paper and electronic) shall be well defined, trained and understood by all relevant staff.

4.3.4. GW will ensure that any serious case (e.g. data mishandling, data falsification) is investigated and if product/study and/or service is concerned, NOVARTIS shall be informed immediately.

4.4. Deviations, Corrective and Preventive Action Systems

4.4.1. Deviation/failure investigations are handled by GW according to the corresponding Standard Operation Procedures (SOPs).

4.4.2. As GW is responsible for QP release of the product in its primary pack, following testing to the registered Finished Product Specification, GW undertakes to close out satisfactorily all Out of Specification investigations, Deviations and Failures which impact on the batch of Product prior to release. In the case where an OOS, Deviation or Failure cannot be resolved prior to batch release, and has an impact on the Supply Chain forecast, Critical and Major items will be brought to the attention of the QA Department at NOVARTIS within twenty-four (24) hours of identifying that the issue will not be resolved.

4.4.3. Critical and Major deviations - deviations may adversely impact product compliance, product specifications, safety, identity, strength, purity and/or violate GMPs or the product licence shall be reported to NOVARTIS by MANUFACTURER without delay (maximum within twenty-four (24), hours upon discovery or within one business day) and shall include the draft investigation report. Final investigation report shall include a description of the deviation, the results of the investigation on the effect to quality and of the cause, and the corrective action and the preventative action. The conclusions of the investigation report shall be collaboratively assessed with NOVARTIS’ representatives prior to MANUFACTURER final disposition of affected Batches. The Certificate of Analysis (CoA) shall contain references to the Deviation numbers.

4.4.4. As a response to a deviation notification, NOVARTIS may request additional information for further clarification of the deviation and specific points to be considered in the investigation. If NOVARTIS sees an urgent need to have a meeting to discuss such deviations GW shall accommodate NOVARTIS’ request within a reasonable time period, and within the closure period of the investigation to allow for active participation. NOVARTIS and GW shall mutually determine how to handle the relevant Product, NOVARTIS reserves a right to reject concerned batches prior to shipment.

4.4.5. GW shall notify NOVARTIS within one (1) business day of any deviation impacting Product(s) already in NOVARTIS’ possession. Additionally, any issues that could potentially disrupt the supply of NOVARTIS’ Products must be immediately communicated to the contact person (Annex A).

4.4.6. GW is responsible to provide a completed investigation report on request to NOVARTIS.

4.4.7. Minor deviations shall be reported in the yearly Product Quality Review.

4.4.8. GW is responsible that Corrective and Preventive Action System is applied according to the corresponding Standard Operation Procedure(s) at the manufacturing site.

4.5. Deviating Products

4.5.1. NOVARTIS has the right to reject Deviating Products in accordance with the provisions of the Supply Agreement.

4.5.2. NOVARTIS shall be entitled to reject a batch, which does not meet the specifications or is not manufactured according to the agreed procedures, GMP requirements or a valid licence. Any dispute regarding the determination of a deviation or failure’s root-cause or the planned corrective and preventative actions shall be resolved in good faith between both Parties. NOVARTIS shall inform GW in writing of any defects not later than sixty (60) business days after receipt of the products. However, concealed defects, which are typically not discovered by routine quality control measures, may be reported within twenty (20) business days after their discovery (terms may vary, to be aligned with Supply Agreement).

4.6. Waste

4.6.1. GW shall destroy waste material in a secure, documented and legal manner, preventing environmental problems and unauthorised use, in accordance with local and international legislation.

4.7. Counterfeiting

4.7.1. GW shall notify NOVARTIS immediately in writing of any known incident or any suspicion of counterfeit Product and shall provide support in any necessary investigation requested by NOVARTIS.

4.7.2. NOVARTIS shall notify GW immediately (within twenty-four (24)) hours in writing of any known incident or any suspicion of counterfeit Product and shall provide support in any necessary investigation requested by GW.

4.8. Complaints

4.8.1. NOVARTIS shall be responsible for handling complaints from the market and shall reply to inquiries as promptly as possible.

4.8.2. In the event that the cause of complaint is suspected to be attributable to the manufacturing/packaging of Product, NOVARTIS shall immediately provide the necessary information to GW and GW shall render assistance to NOVARTIS as required. Complaints of a critical nature (e.g. no effect or side effect, counterfeits, safety issues) will be reported to GW within twenty-four hours (24) or one (1) business day of receipt into NOVARTIS to permit immediate investigation by GW. Other complaints will be reported by NOVARTIS to GW within three (3) business days

4.8.3. GW shall without delay investigate technical complaints and report results to NOVARTIS within twenty (20) business days at the latest. If the test period is unable

to be met, GW shall notify NOVARTIS to arrange an agreed upon timeframe. Based on the results of such investigation, NOVARTIS and GW shall amicably discuss and determine, as necessary, the corrective action and the preventative action.

4.8.4. Complaints of a critical nature (e.g. no effect or side effect, counterfeits, safety issues) first bought to the attention of GW must be investigated without any delay and interim results reported to NOVARTIS within five (5) business days.

4.8.5. Similarly complaints of a critical nature ((e.g. no effect or side effect, counterfeits, safety issues) first bought to the attention of NOVARTIS must be investigated without delay and the interim results reported to GW within five (5) business days and within twenty-four (24) hours of these are linked with any Adverse Event reports (see 4.9 below)

4.8.6. Complaints obtained by GW shall be drawn to the attention of NOVARTIS within five (5) business days. Critical complaints (e.g. no or side effect, counterfeits, safety issues) must be reported within twenty-four (24) hours of receipt.

4.8.7. Compliance with this section on the management of complaints will survive the termination of this agreement to the expiry date plus one year of the last product provided.

4.9. Pharmacovigilance. Adverse Events Reporting.

4.9.1. The Parties agree to adhere to the terms and conditions of the Pharmacovigilance Agreement.

4.9.2. GW is responsible for managing the Sativex ® Safety Database and handling safety reports with the Regulatory Authorities.

4.9.3. If NOVARTIS should receive such reports from any sources, NOVARTIS shall inform GW within the timeframes and using the methods of data exchange provided in the Pharmacovigilance Agreement.

4.9.4. Compliance with this section and the Pharmacovigilance Agreement will survive indefinitely after the termination of this agreement.

4.10. Recalls

4.10.1. In a potential recall situation both Parties shall consult each other and agree on joint action. In cases where there is a product defect, GW and NOVARTIS will identify whether the issue is confined to a local batch or widespread and coordinate the recall accordingly. GW shall reasonably cooperate with NOVARTIS in the event of any such recall and shall provide such assistance in connection therewith as NOVARTIS may reasonably request.

4.10.2. As part of the investigation, GW shall ascertain if the product defect is associated with any batches that have been sent to any of GW’s partners besides NOVARTIS and vice versa for product defects initially associated with other partners’ batches.

4.10.3. NOVARTIS is - in its sole discretion - responsible for the final recall decision, the communication to the Health Authority, the public and surveys the logistic processes regarding returned goods.

4.10.4. NOVARTIS is responsible for liaison with Health Authorities and shall conduct the recall according to its internal procedures. Both Parties shall cooperatively investigate the cause and the corrective action and the preventative action.

4.11. Influence on Quality by “Critical compounds”

4.11.1. GW hereby agrees that it is not permitted to manufacture, package or process the Critical compounds in the same building where NOVARTIS’ Products are manufactured, packaged or processed.

4.11.2. The term “Critical” shall mean any product or process which may reasonably present a potential hazard to any product, such as, by way of example, -lactam-antibiotics, hormones, cytotoxins or biological preparations from live micro-organisms.

4.11.3. According to the note for guidance on “Minimizing the risk of transmitting animal spongiform encephalopathy agents via medicinal products” (EMEA/410/01 Rev.2 or update) GW agrees to advise NOVARTIS by means of a BSE/TSE certificate of compliance mentioning the origin of all starting, packaging and auxiliary materials purchased by GW in product contact. When a Certificate of Analysis (CoA) on starting material is provided to NOVARTIS, it shall clearly state the origin of the material.

4.12. Veterinary Products

4.12.1. GW hereby agrees that it is not permitted to manufacture, package or process veterinary products in the same building where NOVARTIS’ Products are manufactured, packaged or processed.

4.13. Product Quality Review

4.13.1. GW shall provide to NOVARTIS a copy of the annual Product Quality Review (PQR) for Product(s) which summarizes manufacturing history, test results, deviations, change control, information on quality, validation, trending, corrective and preventative actions (CAPA(s)), process capability, conclusions and other items related to the manufacture of Product(s).

4.13.2. Any sub-contracted activity shall be included into the PQR.

4.13.3. The PQR shall be provided to NOVARTIS according to the defined date in the agreed GW format.

4.13.4. GW will prepare the PQR report to include all items detailed in EU Volume 4 Guide to GMP and the NOVARTIS Product Quality Review template.

5. CHANGE CONTROL

5.1. General

5.1.1. GW and NOVARTIS shall utilize a change control procedure to ensure appropriate review of all changes.

5.1.2. NOVARATIS and GW shall review all changes to determine if the change is a Major Change (change may adversely impact product compliance, product specifications, safety, identity, strength, purity and/or violate GMPs, the product licence or registration status). If there is any doubt regarding whether a change is a Major Change, GW shall contact NOVARTIS, and the Parties shall jointly make this determination.

5.2. GW’s proposed Major Changes

5.2.1. GW shall review all changes to determine if the change is a Major Change (change may adversely impact the product licence or registration status). If there is any doubt regarding whether a change is a Major Change, GW shall contact NOVARTIS, and the Parties shall jointly make this determination. GW shall notify NOVARTIS in writing of any Major Changes e.g. to Testing Monographs, facilities, utilities, manufacturing and testing equipment, components, raw material and excipients, manufacturing and testing processes, sub-contractors, equipment, with sufficient detail in order to ensure the Regulatory filings can be made.

5.2.2. Such notifications shall be communicated in writing in a timely manner so as to allow NOVARTIS to evaluate the effect of the change on Products Quality and/or obtain appropriate regulatory authority approvals prior to implementation.

5.2.3. NOVARTIS shall confirm the receipt of such notification within ten (10) business days.

5.2.4. At a minimum, such notification shall contain a description of the change together with the rationale, the proposed implementation date, a GMP assessment, the qualification, validation and/or comparability testing and acceptance criteria, regulatory assessment, medical/safety assessment (if applicable) to prove that the Major Change does not adversely affect the Product Quality.

5.2.5. GW shall provide all Major change documentation in English to NOVARTIS for review and approval. This includes, but is not limited to, the description and rationale of the change and supporting documentation such as validations or technical assessments.

5.2.6. GW will provide NOVARTIS with the updated relevant regulatory dossier sections ready for the relevant Submission to the Regulatory Authorities.

5.2.7. Within 40 (forty) business days of receipt of the change request and all supporting documentation, NOVARTIS shall review the change, request additional information and provide the change request status update.

5.2.8. GW and NOVARTIS Regulatory personnel will work together to agree on a final submission to the Authorities. NOVARTIS will make the submission and inform GW of the likely approval date and of the final approval date immediately. GW will maintain a log of all dossier sections and the status of submission of these in all NOVARTIS countries.

5.2.9. In case of regulatory relevant changes, the “changed” Product shall only be implemented and shipped to NOVARTIS once communicated by NOVARTIS in writing.

5.2.10. After completion of a Major Change, GW shall provide NOVARTIS’ Quality Assurance contact in writing with dates of implementation of the change.

5.3. GW’s proposed Minor Changes

5.3.1. Minor changes (change may not adversely impact product compliance, product specifications, safety, identity, strength, purity and/or violate GMPs, the product licence or registration status) may be notified to NOVARTIS at a regular frequency (e.g. quarterly) and included in the Product Quality Review.

5.3.2. Test method changes resulting from the update of compendia and pharmacopoeia are considered Minor Changes, and may be made by GW without NOVARTIS formal approval. GW shall notify NOVARTIS of such changes in specifications in writing and define the implementation date, such changes to be included in the annual Quality Agreement review.

5.3.3. It is understood between all the Parties that when a material’s Testing Monograph references a pharmacopoeia test method, the current version of the pharmacopoeia test method is to be used. The GW must have a process to update methods and to ensure the current Pharmacopoeia/s is being used.

5.4. NOVARTIS proposed Changes

5.4.1. NOVARIIS shall notify GW of any Product specific changes required (e.g. from Health Authorities relating to storage conditions and shelf life).

5.4.2. Such notifications shall be communicated in writing in a timely manner as part of the NOVARTIS Change Control so as to allow GW to evaluate the change following applicable Standard Operating Procedures.

5.4.3. GW’s review and approval/rejection of Product changes shall be performed based on the effect of such of Product specific changes on product quality. Such approval/rejection of Product specific changes shall not to be unreasonably withheld. GW shall implement all approved Product specific changes required by NOVARTIS in a timely manner and in accordance with GW’s procedures and the provisions of the Manufacturing and Supply Agreement.

6. STARTING MATERIAL

6.1. General Principles

6.1.1. All suppliers have to be known and approved by the GW. The GW must have a supplier management programme for the initial qualification of suppliers and on-going quality oversight.

6.1.2. Materials have to be sourced directly from original GWs and not from wholesalers whenever possible. However, supply from tied agents is acceptable, providing transparency about the supply chain is ensured and procedures are in place to ensure supply chain integrity.

6.1.3. Requirements in this chapter apply to all suppliers of all types of materials included but not limited to botanical / API starting materials / botanical intermediates, internal

products, API’s, excipients, pharmaceutical intermediates, primary packaging materials printed secondary packaging materials, medical devices and process aids.

6.1.4. Both Parties may rely on results obtained by the respective supplier qualification programmes. Both Parties agree to share the corresponding qualification reports among each other or a list of Suppliers with audit status.

6.1.5. GW is responsible to ensure that, a due diligence audit is performed and respective corrective actions are implemented before the first material supply.

6.2. Supplier Questionnaires

6.2.1. The GW is required to send out a supplier questionnaire to all suppliers of all types of materials listed in the ‘Starting Materials’ General Principals Chapter above.

6.2.2. The GW is required to assess the quality of the suppliers and in the supplier questionnaire must include questions related to general organisation, QA systems, production, and analytical processes.

6.3. Supplier Audit

6.3.1. GW is required to establish Quality Agreements with its API and non-active raw starting material suppliers. GW shall provide copies of Quality Agreements with its suppliers, on request, to NOVARTIS.

6.3.2. GW shall perform supplier audits, and consecutive follow up audits, and provide copies of audit reports on request to NOVARTIS as part of the supplier qualification programme during audit by NOVARTIS.

6.3.3. As part of an audit programme, GW is responsible to audit the suppliers to verify the supply chain integrity including an assessment of the supplier’s supplier qualification programme and proof of pedigree of Supply Chain to the main manufacturer and material transport conditions. These audits shall be performed to ensure Supply Chain Integrity and should also cover security. In response to the audit observations, GW is responsible to ensure that corrective action plans are created and implemented by the supplier.

6.4. Procurement of Active Pharmaceutical Ingredient

6.4.1. GW is fully responsible for the manufacture of the Active Pharmaceutical Ingredients and compliance with GMP (Q7). GW will provide a corresponding certificate(s) to NOVARTIS on request for all APIs used in batches of drug product supplied to NOVARTIS.

6.4.2. GW shall apply the manufacturing methods and Testing Monographs (comprising specifications as well as methods) as set forth in Annex B.

6.4.3. By means of TSE-certificate, GW shall certify that the quality of the API is in compliance with the current “Note for Guidance on minimizing the risk of transmitting spongiform encephalopathy agents via human and veterinary medicinal products” EMEA/410/01, Rev. 3 or update (“TSE Guidelines”) as part of the QP Release Certificate.

6.5. Procurement of Non-Active Raw Starting Material

6.5.1. GW shall establish approved suppliers of raw materials. Changes of these suppliers shall be subject of the change control process.

6.5.2. Non-active raw starting materials are procured by GW from the approved suppliers as determined in Annex B.

6.5.3. Material initial origin must be stated on the applicable certificate(s), and made available upon request from NOVARTIS.

6.5.4. Under the Quality Agreement with suppliers, GW will ensure that there is a commitment by the supplier to use a particular source of supply/manufacture, any changes being subject to a change procedure.

6.5.5. GW shall inform NOVARTIS within five (5) business days on recalls or call-back of material by suppliers (related to the products defined in this Quality Agreement), for quality or safety reasons for those batches assigned to NOVARTIS.

6.5.6. Upon receipt, all non-active raw starting materials have to be container-wise identity tested and tested for compliance with the approved specifications as defined below.

6.6. Starting Material Receipt, Testing Control, and Release

6.6.1. GW shall implement and maintain component, raw material and API Testing Monographs (consisting of Specifications and Analytical Methods) according with agreed specifications.

6.6.2. GW shall create, approve and maintain component, raw material and API sampling (and reduced sampling) plans following internal written Standard Operating Procedures. Sampling plan rational must be documented.

6.6.3. GW shall receive, sample, test, control and release components, raw materials and API for the Product in accordance with the sampling plans and with approved Testing Monographs and specifications (Annex B).

6.6.4. GW shall ensure that sampling for testing (at least identity) of starting materials, is performed from each container. Exceptions to these requirements are only allowed to be made when a certification programme for reduced testing has been approved by the GW for a specific supplier. GW shall ensure that terms and conditions for reduced testing are agreed in writing in a separate Quality Agreement with the supplier.

6.6.5. Reference samples of starting materials must be kept according to the Reference Sample Chapter 8.2.1.

6.7. Storage

6.7.1. GW shall store starting materials under GW standard storage conditions which have been checked by NOVARTIS during audit and considered as suitable and appropriate for the above purpose. Storage containers and storage/transport conditions must ensure that the specified quality of starting materials is not impaired.

6.8. Measures Ensuring Supply Chain Integrity

6.8.1. GW is to ensure that suppliers of primary packaging materials adhere to any security arrangements as part of supply chain integrity.

6.8.2. GW is to ensure that critical aspects of the supply chain are considered concerning the whole material flow and their related processes in order to ensure protection against mix-ups, contaminations.

6.8.3. GW is to ensure that all container types (defined based on the stability programme) must be closed in a way to ensure supply chain integrity. The outer containers for APIs should be closed with traceable specific seals (e.g. numbered) and the related information is part of the shipping documentation.

6.8.4. GW is to ensure that appropriate measures are applied to the pallets used for drug product to ensure that their integrity is maintained from their preparation until receipt at the manufacturing site. All pallets used must be heat treated.

6.9. Transport from Suppliers to GW

6.9.1. It should be noted that the Products are all Controlled Drugs and so as part of the Supply Chain, movements of materials related to the API and Product are subject to Home Office orders. When transport is performed by, or on behalf, of GW, assurance that the transport companies are approved and ensure supply chain integrity must be obtained by GW.

6.9.2. Quality Agreements will be in place with all key suppliers and will include supply chain integrity to cover the following:

6.9.3. Measures ensuring supply chain integrity to be taken by GW.

6.9.4. All procedures are in place to ensure supply chain integrity between the suppliers and the GW.

6.9.5. GW is to ensure that during the whole transportation chain the integrity of the containers / pallets is ensured by appropriate measures.

6.9.6. GW shall ensure that appropriate measures are in place to ensure secure transportation conditions and to prevent product tampering and theft (e.g. tamper evident mechanisms, photo libraries).

6.9.7. GW shall ensure, in case of deliveries by tanks, traceability of the materials transported previously must be available and cleaning validation performed, unless tanks are dedicated.

7. PRODUCT MANUFACTURING

7.1. General Principals

7.1.1. GW is responsible that procedures for material receipt are in place to verify conformity of the product received with the corresponding transport documents (Recommendation is to have a photo library for incoming goods representing how the drums should be delivered).

7.1.2. GW is responsible that 100% container-wise identity check is performed.

7.1.3. GW is responsible that after receipt of the materials, internal transport and storage within the manufacturing site is performed according to procedures ensuring supply chain integrity (e.g. identification, avoidance of mix-ups & contaminations, prevention of tampering & theft, access restricted warehouse).

7.1.4. GW is responsible that traceability of the components used in APIs and finished product is ensured.

7.1.5. Narcotics have to be handled according to the current valid Controlled Drugs regulations.

7.2. Manufacturing, Packaging, Testing Documents and Specifications

7.2.1. GW shall apply the manufacturing methods and Testing Monographs (comprising specifications as well as methods) as agreed with NOVARTIS and referenced in Annex B.

7.3. Batch Manufacturing and Packaging Records

7.3.1. GW assures that manufacturing, filling and packaging of the Product is carried out according to the approved manufacturing procedures and packaging instructions.

7.3.2. GW compiles and archives clear structured batch documentation for each batch of the products. The manufacturing batch records as well as testing documentation have to comply with the GMP guidelines.

7.3.3. GW assures that upon special requests from NOVARTIS or Health Authorities the following documents shall be provided as copies within two (2) working days to NOVARTIS: complete manufacturing batch record of bulk products, certificate(s) of analysis of API, excipients and primary packaging materials, test methods used, etc.

7.4. Sampling Plans

7.4.1. GW shall implement and maintain In-Process Material and the Products sampling plans as required. Sampling plans shall be documented in approved manufacturing procedures and recorded in batch specific Master Processing Records.

7.5. Reprocessing

7.5.1. GW hereby agrees that it will not use any material for NOVARTIS that does not meet specifications after testing.

7.5.2. Reprocessing of intermediate drug product and drug product by an appropriate and authorised procedure after evaluation of the risks involved is only allowed in exceptional cases and is in the registered method of manufacture, provided that material is suitable for such a process and the resulting Product meets its specifications with no significant changes in Product quality.

7.5.3. Where reprocessing is required, NOVARTIS will be informed prior to reprocessing, and the instructions to perform such reprocessing shall be documented into the appropriate master production records.

7.5.4. NOVARTIS does not permit any rework of products or product intermediates in the sense of performing process steps that are different from the agreed manufacturing process, such as using different solvents or changing the batch size outside of +/- 10% of registered size.

7.5.5. Repackaging activities (i.e. reprocessing of assembled or partially-assembled packs) are allowed only in exceptional cases and require prior written approval from NOVARTIS.

7.6. Batch Certification

7.6.1. After detailed review of the batch documentation of each batch, GW is responsible to ensure that a Certificate of Compliance with GMP (CoC, confirmation statement) is included or attached to the CoA, Deviation Statement if applicable, that is signed by a Quality Assurance person (Qualified Person).

7.6.2. A copy of one complete Batch Record shall be sent to NOVARTIS annually and upon request.

7.7. Warehousing

7.7.1. GW is responsible to ensure that products are stored under appropriate conditions of temperature and humidity, light and cleanliness so that identity, strength and purity of the products are not affected. In the event that the quality of the NOVARTIS products in the warehouse could be adversely affected for any reason, GW shall take immediate action to prevent further damage. In such case GW shall inform NOVARTIS in writing within five (5) working days.

7.7.2. The requirements regarding the storage of the products are defined in Annex B.

8. QUALITY CONTROL (QC)

8.1. Quality Control Testing and Approval

8.1.1. GW shall ensure that the Certificate of Analysis (CoA) for the Product complies with internationally harmonised requirements for batch certification including: batch specific information; document code of testing instruction; tests results and specifications; name and address of all manufacturers involved in the manufacture of products; the number of manufacturing authorization/licence and/or GMP compliance certificates applicable; certificate of compliance (with GMP).

8.1.2. Wherever possible QC testing will include a check for integrity of product to prevent counterfeiting. NB: It should be noted that all stages of manufacture from API to bulk vials of Finished Drug Product are manufactured under the direct control of GW with all but one activities being carried out on the same site.

8.2. Reference Standards

8.2.1. The reference standards for testing of products, by-products or degradation products are established by GW and are provided to NOVARTIS on request. Reference

Standards must be purchased from a reliable, certified source or manufactured by GW.

8.3. Out of Specification (OOS) Quality Control Testing Results

8.3.1. GW shall conduct an initial investigation of all OOS results to determine whether or not they were caused due to laboratory error, according to internal OOS SOP.

8.3.2. If the initial investigation concludes, without additional testing, that laboratory error occurred, GW may proceed to re-sample and/or retest the material following the internal OOS SOP.

8.3.3. If the initial investigation cannot confirm laboratory error GW shall, within forty eight (48) hours notify NOVARTIS in writing per the deviation section if the OOS is Critical and impacts on the Supply Chain.

8.3.4. GW shall conduct a manufacturing investigation compliant with internal OOS SOPs. The conclusions of the investigation report shall be collaboratively assessed with NOVARTIS’ representatives prior to GW final disposition of affected Batches if there is a product failure which impacts on the Supply Chain.

8.3.5. GW shall conduct an initial investigation of all non-batch related OOS results (e.g. Qualification, Validation, Filter Testing, processes, equipment and utilities in general). If the outcome of the investigation indicates wider failure of NOVARTIS batches than indicated in 8.3.4 above, GW will inform NOVARTIS QA.

8.3.6. In any case all such OOS investigations will be summarised in the Annual Product Quality Review.

9. ARTWORK

9.1. General

9.1.1. The handling of artwork must be defined in respective internal procedures following GMP principles (for details see Annex D) and is the responsibility of NOVARTIS with help and support from GW.

10. RETENTION OF SAMPLES AND DOCUMENTATION

10.1. General

10.1.1. The minimum archiving period for GW is 20 years and all records will be kept for this time - the archiving period of GW will prevail. In any event GW will ensure that samples and documentation related to the manufacture of the Product and Active Pharmaceutical Ingredient are retained for the minimum times below as follows:

Item

Retention Period

Retention samples:

· Finished medicinal product

· Batch expiry date + 1 yr

Retention samples:

Batch records (i.e. production, control, distribution and QA records) for:

· API — original release

· API — with re-test date

· Finished medicinal product & bulk medicinal product

· Batch expiry date + 1 yr

· Until batch completely distributed + 3 yrs

· Batch expiry date + 1 yr

Reference samples

· API — original release

· API — with re-test date

· Batch expiry date +1 yr, or Until batch completely distributed + 3 yrs, whichever is longer

· Until batch completely distributed + 3 yrs

· Other component or starting material released for use in a marketed medicinal product, including primary and printed packaging materials

· Packaged medicinal product (drug product), batches released for the market

· Release date of finished product + 2 yrs

· Batch expiry date +1 yr

Product Specification Documentation:

· Master Manufacturing Formulas, Validation Master File (Change Control), all documents which form part of regulatory submissions, product development and validation batch documentation, product development history and reports.

· Other specifications for materials and products, manufacturing formulations, processing and packaging instructions, testing instructions, annual product review

· Until final withdrawal of the product from the market + 10 yrs

· Until final withdrawal of the product from the market + 10 yrs, or until superseded + 10 years

Complaints - pharmaceutical products

· Records of Medical complaints

· Samples related to Medical complaints

· Records of Technical complaints

· Samples related to Technical complaints

· Retain as Pharmacovigilance records

· Until legal limitations have expired

· Expiry date of product batch + 1 yr, or Receipt of complaint + 1 yr, whichever is longer

· Close-out of complaint + 1 yr.

Pharmacovigilance documents*

· In accordance with GW procedures but at least 20 years.

Documentation of facilities (buildings, plant, machinery and other equipment, IT Systems etc.) including:

· Standard Operating Procedures,

· Until the last productive use of the facility, plant, machinery, equipment or system +10 yrs, or Until document superseded + 10 yrs

qualification, calibration and validation documentation, test, inspection and audit reports.

Organisational Records

· Records of organizational structure, positions and responsibilities of personnel.

· Until superseded + 10 yrs

Personnel Records

· Personnel qualification and training records

· Until employment ends + 10 yrs

10.1.2. * Records of Pharmacovigilance reports received directly by NOVARTIS and reported to GW will be kept by NOVARTIS in accordance with archiving times in the Pharmacovigilance Agreement.

10.1.3. If the Quality Agreement expires or terminates before the retention period ends according to the GMP-rules, then the samples and the documents shall be stored until this period officially ends.

10.1.4. GW ensures that — on special request from NOVARTIS, e.g. in response to a health authority request — reference samples are provided for dispatch within two (2) business days by certified letter. The samples must be shipped under the same condition as the batch they represent. NOVARTIS shall confirm the receipt.

10.1.5. GW shall ensure that the reference sample amount to be stored shall be sufficient to perform two (2) full tests according to the testing instruction.

10.1.6. Following the end of the archiving period, which will be 20 years in accordance with GW procedures, GW shall provide the documentation to NOVARTIS upon written request.

11. RELEASE OF THE PRODUCT

11.1. Release for Shipment — “Technical Release” — Pre-requisites

11.1.1. Following the testing of Products, the review of the batch documentation and confirmation of compliance with GMP and valid licence GW shall release the Product for shipment to the hand-over point as defined in the Trading Service Procedure. It should be noted that as the Product expert, GW will carry out a Qualified Person release on the packed product before release for shipment to NOVARTIS.

11.2. Shipment under Quarantine

11.2.1. Shipment of the Product under quarantine, i.e. without meeting the pre-requisites for shipment to the hand-over point as defined in chapter above, require written approval from NOVARTIS prior to shipment and the appropriate labelling. NOVARTIS shall keep the Product under quarantine until GW formally releases the products.

11.3. Release to the Market

11.3.1. The release of the Product to the market is the responsibility of NOVARTIS as defined by the relevant marketing authorisation.

12. STORAGE

12.1. Storage and Packaging for Dispatch

12.1.1. GW is responsible for ensuring that the requirements regarding the storage, labelling and packaging for dispatch of the Product pursuant to Annex B are met.

13. TRANSPORT IS PERFORMED BY NOVARTIS

13.1. Pick-up and Transport of Product from GW is performed by NOVARTIS

13.1.1. NOVARTIS is responsible for the transport and possible interim warehousing of the Product to the agreed hand-over point (ex-works) according to the CIP Incoterm 2000 (to be matched with Supply Agreement).

13.1.2. GW is responsible for ensuring that temperature monitoring has been implemented for all shipments to NOVARTIS by using the dataloggers supplied by NOVARTIS.

13.1.3. NOVARTIS is responsible that regular audits of the transport companies and warehouses are conducted to assess their ability to ensure the supply chain integrity and Product integrity.

13.1.4. NOVARTIS is responsible for ensuring that a QA agreement with the transport company(s) is in place.

13.2. Air Freight

13.2.1. NOVARTIS is responsible for performing regular audits to ensure the supply chain integrity with handling agents for air freight, general sales agents for airlines, cargo and handling agents at airports.

13.2.2. NOVARTIS is responsible for ensuring that all shipments booked as perishable cargo must occur as per IATA regulations.

13.3. Road Freight

13.3.1. NOVARTIS is responsible for ensuring that regular audits with road freight forwarders are conducted to ensure their ability to fulfil supply chain integrity.

13.3.2. NOVARTIS is responsible for ensuring that only insulated or temperature controlled, hard-sided (“box trucks”) and locked / sealed trailers are authorized. Curtain-sided trucks are not permitted.

13.3.3. In order to discourage theft of higher risk shipments (e.g. to or in countries at risk, higher black market potential, narcotics, high value products, patient impact), appropriate measures are highly recommended by NOVARTIS, e.g. having 2 drivers, informing them that they are being tracked, use of chase cars, use of covert tracking devices and services for constant surveillance of truck, definition of routes &

intermediate stops and where appropriate qualification and / or validation of the shipping process.

14. PRODUCT RECEIPT BY NOVARTIS

14.1. General

14.1.1. Incoming Product shall be checked by NOVARTIS for correctness and completeness with the appropriate documentation prior to storage.

14.1.2. These checks shall cover and include the following steps: external condition and intact, authentic seal; compliance of the containers and labelling with the delivery documents and the Certificate of Analysis.

14.1.3. If deviations (including documentation, labelling, etc.) are detected, they shall be notified to GW and handled according to the procedure for Deviating Product set out herein and the Manufacturing and Supply Agreement.

15. STABILITY TESTING

15.1. General

15.1.1. Primary packaging by GW: GW is responsible for maintaining a follow-up stability programme under ICH conditions or as required by local legislation. NOVARTIS will supply fully packed product for this purpose taken from an agreed assembled batch destined for the marketplace. The format, template and schedule for submission of the stability data and reports will be according to the GW format ensuring that all aspects of the NOVARTIS template have been covered. GW shall investigate any stability failures and will notify NOVARTIS within twenty four (24) hours of any confirmed OOS that will become a critical deviation.

16. COMPLIANCE AUDITS AND INSPECTIONS

16.1. Audits

16.1.1. GW shall permit NOVARTIS to conduct preparatory audits for GMP manufacture of the Product, pre-approval audits, for-cause audits and routine and follow-up compliance audits. Such audits are intended to assure NOVARTIS that GW maintains adequate premises, equipment and staff with sufficient knowledge and experience to carry out all operations relating to the Product.

16.1.2. NOVARTIS shall be entitled to audit formally the GW’s facilities and the records and to send duly authorised technical representatives and/or quality representatives to the Facilities to be present once every 3 years after the Product launch, at a time and date to be agreed in advance between the Parties.

16.1.3. For-cause audits, by nature, shall require scheduling as soon as possible.

16.1.4. NOVARTIS shall provide a written report to GW of all observations made during all audits within thirty (30) days of completion of the audit.

16.1.5. GW shall consider NOVARTIS’ recommendations and implement appropriate changes.

16.1.6. GW shall provide a written response to NOVARTIS within thirty (30) days of receipt of the audit report. Such response shall describe in detail the corrective actions to be implemented by GW.

16.1.7. NOVARTIS reserves the right to stop any operation for NOVARTIS if activities should be observed, violating agreed upon standards and regulations. GW shall implement corrective actions before continuation of its operations.

16.1.8. The audit rights shall survive one year after expiry of last Product supplied.

16.2. Health Authority Inspections

16.2.1. GW shall allow foreign and local governmental authorities to inspect facilities, operations and quality systems, as it is necessary to facilitate, obtain or maintain the registration in the countries where NOVARTIS or its affiliates, licensees or distributors, as the case may be, desire to sell the products. A representative of NOVARTIS may participate in such inspections upon written request to GW in respect of those Regulatory Authorities from the countries where the Product is marketed by NOVARTIS.

16.2.2. If a Regulatory Authority from one of the countries in which NOVARTIS is marketing the product contacts GW or gives notice of its intention to conduct, an inspection at the facilities of the operations and quality systems or takes, or gives notice of its intention to take any other regulatory action alleging improper or inadequate practices with respect to any activity of GW in connection with the Product, GW shall notify NOVARTIS within five (5) days of such contact or notice, or sooner if necessary to permit NOVARTIS to exercise any rights it may have to be present at, or otherwise participate in, any such inspection or regulatory action.

16.2.3. Unless prohibited by applicable law or by the Regulatory Authority conducting the inspection, NOVARTIS shall have the right to be present at and to participate in any such inspection or regulatory action in respect of GMP activities that are the responsibility of NOVARTIS and the parties shall discuss in good faith any response thereto proposed by GW.

16.2.4. If any of NOVARTIS’ personnel shall not participate in such inspection or regulatory action, GW shall immediately inform NOVARTIS about critical or major issues encountered during authority inspections that might adversely affect the quality of Products manufactured for NOVARTIS and must provide a copy of the inspection report or an excerpt and the proposed corrective actions within ten (10) business days from receipt of inspection report.

16.2.5. When requested by regulatory agencies or governmental inspections, NOVARTIS reserves a right to disclose evidence of GMP audits or other GMP related documentation issued by NOVARTIS and/or its Affiliates related to GW.

17. TERM AND EXPIRATION OF THE QA AGREEMENT

17.1.1. This Quality Agreement forms an integrated part of the Manufacturing and Supply Agreement and shall come into force together with the Manufacturing and Supply Agreement and sign-off by the Parties hereto. This Quality Agreement shall be terminated upon expiration or termination of the Manufacturing and Supply Agreement, except for the sections indicated herein.

18. DEFINITIONS

18.1.1. Except as otherwise provided herein, capitalised terms used in this Quality Agreement shall have the meaning given in the Manufacturing and Supply Agreement.

18.1.2. GMP definitions will be the same as those in The Rules Governing Medicinal Products in the European Union, Volume 4: EU Guidelines to Good Manufacturing Practice for Human and Veterinary Use

18.1.3. Repackaging will have the same meaning as Reprocessing but as applied to assembled or partially assembled packed stock. In general the repackaging activity will involve the exchange of one or more components for other up-versioned ones.

19. SURVIVAL

19.1.1. Any of the provisions of this Quality Agreement, including the Annexes that are expressed or implied to survive the expiration or termination of this Quality Agreement shall remain in full force and effect one year after expiry of last Product supplied except for the reporting of adverse events.

20. SIGNATURES

NOVARTIS		GW

Signature/Date		Signature/Date

/s/Aldo Giorgetti 06.12.2011		/s/ Marilyn Emery 21 Dec. 11
*Aldo Giorgetti*		*Marilyn Emery*

Pharma Supply Chain QA Head		Director of Quality

/s/ Christoph Moeschli 2/12/11		/s/ Steven Stuart 10/01/12
*Christoph Moeschli*		*Steven Stuart*

External Supply QA Head		Site Head of Quality

ANNEX A: Contact Details

NOVARTIS

Name	Function	Address
***	* *	* * * * ***
***	***	***
***	***	***

*******	*******	*******
***	* * ***	* * * * ***
***	***	***
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Name	Function	Address
***	* *	* * * * ***
***	***	***
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Name	Function	Address
***	QC Manager	* * * * ***
Telephone	Mobile Phone	e-mail
***		***

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Name	Function	Address
***	***	* * * * ***
***	***	***
***		***

***	***	***
***	***	* * * * ***
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

NOVARTIS		GW


Signature/Date		Signature/Date


/s/ Thomas Pracht		/s/ Marilyn Emery
Dr. Thomas Pracht		Marilyn Emery
External Supply/QA Manager		Director of Quality

ANNEX B: Manufacturing and Testing Documents

Starting Materials and Components

Material Name	Supplier	Procured by/from	Material Specifications Document Code	Valid Date
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***
***	***	***	***	***

Products*

Product Name		GW Code		NOVARTIS Code		Testing Monograph Code/Valid Date		Manufacturing Document Code/Valid Date
***		***		***		***		***

* Following the version listing in the Quality Agreement all updates will be via the annual review of annexes of the Quality Agreement .

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Storage and Transport Conditions

Product Name		Storage Conditions		Transport Conditions		Accepted OOS Tolerance for Storage		Accepted OOS Tolerance for Transport
***		***		***		***		***

Product Quality Review Schedule

Product Name / NOVARTIS Product Code		Review Period		Submission to NOVARTIS Due Date
***		***		***

NOVARTIS		GW


Signature/Date		Signature/Date


/s/ Thomas Pracht		/s/ Marilyn Emery
Dr. Thomas Pracht		Marilyn Emery
External Supply/QA Manager		Director of Quality

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX C: FUST and Samples Programmes

Follow-Up stability Programme

Testing Schedule

Product Name

Pack. Type

Storage Conditions

***

R = Results of release testing, 12, 24 = storage time in months
X = Sample is tested
(X) = Matrixing approach, sample is stored, but not tested

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Sample List

Product Name	Sample Purpose	Sample Quantity	Presentation	Delivered From	Delivered To

NB: When GW requires samples for product from NOVARTIS for Product Quality Review testing, a request will be included in an e-mail to the respective QA Department

NOVARTIS		GW


Signature/Date		Signature/Date


/s/ Thomas Pracht		/s/ Marilyn Emery
Dr. Thomas Pracht		Marilyn Emery
External Supply/QA Manager		Director of Quality

ANNEX D: Table of Responsibilities

N = NOVARTIS

G = GW

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NOVARTIS		GW

Signature/Date		Signature/Date


/s/ Thomas Pracht		/s/ Marilyn Emery
Dr. Thomas Pracht		Marilyn Emery
External Supply/QA Manager		Director of Quality

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX E: List of Approved Sub-Contractors

Sub-Contractors Legal Name and Address		Services Performed
* * * * * *		***

* * * *		***

NOVARTIS		GW

Signature/Date		Signature/Date


/s/ Thomas Pracht		/s/ Marilyn Emery
Dr. Thomas Pracht		Marilyn Emery
External Supply/QA Manager		Director of Quality

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

ANNEX F: History of Changes

Document Part	Version	Date	Reason for change
Core Agreement	1.0	{dd.mm.yyyy}	New
Annex A	1.0	{dd.mm.yyyy}	New
Annex B	1.0	{dd.mm.yyyy}	New
Annex C	1.0	{dd.mm.yyyy}	New
Annex D	1.0	{dd.mm.yyyy}	New
Annex E	1.0	{dd.mm.yyyy}	New
Annex F	1.0	{dd.mm.yyyy}	New
Core Agreement	2.0	{dd.mm.yyyy}

NOVARTIS		GW

Signature/Date		Signature/Date


/s/ Thomas Pracht		/s/ Marilyn Emery
Dr. Thomas Pracht		Marilyn Emery
External Supply/QA Manager		Director of Quality

EXHIBIT C

Standard form Trading Services Procedures

Exhibit 10.24

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated 7 March 2007

G W Pharma Limited

- and -

*** Limited

PRODUCTION AND SUPPLY AGREEMENT

MORRISON FOERSTER

A MULTINATIONAL PARTNERSHIP

CityPoint, One Ropemaker Street London EC2Y 9AW

Tel: +44 20 7920 4000 Fax: +44 20 7496 8500

www.mofo.com

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

TABLE OF CONTENTS

		Page

1.	DEFINITIONS AND INTERPRETATION	1

2.	TERMINATION OF PRE-EXISTING ARRANGEMENTS BETWEEN THE PARTIES	11

3.	APPOINTMENT	11

4.	KNOW-HOW TRANSFER/SUPPLY OF PLANTS	12

5.	PRODUCTION, DELIVERY AND ACCEPTANCE	13

6.	INSPECTIONS AND AUDITS	16

7.	INFORMATION SHARING	17

8.	DOCUMENTATION, RECORDS AND PERMITS	17

9.	FURTHER RIGHTS, OBLIGATIONS AND RESPONSIBILITIES	18

10.	CONSIDERATION	18

11.	INTELLECTUAL PROPERTY	22

12.	CONFIDENTIALITY	23

13.	WARRANTIES AND LIABILITY	25

14.	INSURANCE	28

15.	TERM AND TERMINATION	28

16.	RIGHTS SHORT OF TERMINATION	31

17.	MISCELLANEOUS	33

SCHEDULE 1—PRODUCTION PLANNING PROCEDURE		39

SCHEDULE 2—BUDGET FOR COSTS 2007		45

SCHEDULE 3—EXPERT DETERMINATION		46

SCHEDULE 4—AGREED CATEGORIES OF SUSPENSION COSTS		48

THIS PRODUCTION AND SUPPLY AGREEMENT , is entered into on the 7th day of March 2007

BETWEEN:

(1) GW PHARMA LIMITED , a company incorporated in accordance with the laws of England (Company No. 03704998) whose registered office is at Porton Down Science Park, Salisbury, Wiltshire SP4 oJQ (“ GW ”); and

(2) *** LIMITED (trading as ***) , a company incorporated in accordance with the laws of England (Company No. ***) whose registered address is *** .

WHEREAS

(A) GW is developing medicinal products based on the properties of cannabis and owns or otherwise controls certain patent rights, know how and plant variety rights covering or otherwise relating to such products.

(B) *** has the facilities and expertise necessary, in conjunction with GW Know How (as defined herein), to grow, process and supply cannabis in dried form to GW for use in medicinal products and owns certain Know How (as defined herein) of its own covering or otherwise relating to general horticultural processes and techniques.

(C) On 16 May 2003 GW and *** entered into the Original Production and Supply Agreement (as defined herein) which set out the terms upon which *** was appointed as the exclusive third party producer and supplier of cannabis material to GW for the development of GW’s cannabis based medicinal products.

(D) On 5 January 2006 *** and GW entered into the Commercial Heads of Terms (as defined herein) regarding the appointment of *** as a third party supplier to GW of BRM for its requirements thereof both for development and Commercialisation of BDP (all as defined herein).

(E) GW now wishes to appoint *** as a third party supplier to GW of BRM to meet GW’s requirements therefor both for development and Commercialisation of BDP, and *** wishes to accept this appointment on the terms below.

IT IS THEREFORE AGREED AS FOLLOWS:

1. DEFINITIONS AND INTERPRETATION

1.1 The following terms as used in this Agreement shall have the meanings set forth in this Clause.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“Additional Area” — the *** additional area at the Premises available for the growth of Plants.

“Affiliate” — any company, partnership or other business entity which controls, is controlled by or is under common control with either Party. For the purposes of this definition only, “control” refers to any of the following: (a) the possession, directly or indirectly, of the power to direct the management or policies of an entity, whether through ownership of voting securities, by contract or otherwise; (b) ownership of fifty percent (50%) or more of the voting securities entitled to vote for the election of directors in the case of a corporation, or of fifty percent (50%) or more of the equity interest in the case of any other type of legal entity; (c) status as a general partner in any partnership, or any other arrangement whereby a Party controls or has the right to control the Board of Directors or equivalent governing body of a corporation or other entity.

“Agreement” — this contract between GW and *** for the supply of BRM as set out in this document and the Schedules hereto.

“Batch” — the BRM resulting from harvesting Production Plants of a single Chemovar grown from Cuttings taken and propagated in the same week, later transferred to the Flowering Zone (as defined in the Technical Agreement) in the same week, treated in all practical terms identically and Harvested on the same day.

“Batch Records” — all records held by ***, which relate directly to the Production of a Batch.

“Botanical Drug Product (BDP)” — the pharmaceutical product for human therapeutic use containing BDS extracted from BRM of both Chemovars known at the Effective Date as Sativex, in any dosage form or delivery presentation in its patient pack.

“Botanical Drug Substance (BDS)” — the final extract from a Chemovar (i.e. the Active Pharmaceutical Ingredient) for use in the BDP after the BRM has been winterised and evaporated. This is the accepted GW term and is also used in the USA. Also known as Herbal Drug Preparation in Europe.

“ Botanical Raw Material ” or “ BRM ” — the dried aerial parts of a Chemovar after it has been stripped from the stems of Production Plants, but before it has been processed further, in a form suitable for use as the starting material for extraction of Botanical Drug Substance. For the purposes of the Technical Agreement the BRM may also be referred to as “The Product”.

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“BRM Specifications” — the specifications set out in the Technical Agreement (as such specifications may be amended from time to time) including (i) the specifications for pre-milled BRM and (ii) the Growing Protocol.

“Business Day” — 9.00am to 5.30pm on a day other than a Saturday, Sunday or public holiday in England and Wales.

“Budget for Costs” — as defined in Clause 10.1.1.

“Certificate of Release” — a certificate of release provided to GW by *** approved by the appropriate personnel of ***, which will accompany each Batch, and which states that at the time of release (i) the Batch has been Produced in all material respects in accordance with the BRM Specification, GAP and the Technical Agreement, and (ii) that in the reasonable opinion of *** the Batch is acceptable for collection by GW.

“Change of Control” — the transfer or issue of shares in the capital of either of the Parties which when completed, would result in any shareholder (together with any person acting in concert with that shareholder (within the meaning given in the City Code on Takeovers and Mergers as in force at the Effective Date)) holding more than 50% of the total number of shares in the capital of such Party.

“Chemovar” or “Chemovars” - (i) the chemovar of Cannabis sativa L . which has been genetically and chemically characterised by GW and which produces delta-tetrahydrocannabinol as the dominant cannabinoid, and/or (ii) that chemovar of Cannabis sativa L . that has been genetically and chemically characterised by GW and which produces cannabidiol as the dominant cannabinoid.

“Commercialisation” , “Commercialising” , or “Commercialise” — all activities relating to the import, advertising, promotion and other marketing, pricing and reimbursement, detailing, distribution, storage, handling, offering for sale and selling, customer service and support, post- Marketing Authorisation clinical studies and regulatory activities including adverse event reporting of a BDP.

“Commercial Heads of Terms” — the letter agreement made between the Parties dated 5 January 2006 containing the binding heads of terms for this Agreement.

“Competent Authority” — any national or local agency, authority, commission, department, inspectorate, minister, ministry, official, parliament, public or statutory person (whether autonomous or not) or other instrumentality of the European Community or government of any

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

country having jurisdiction over either any of the activities contemplated by this Agreement or over the Parties.

“Confidential Information” — the following, subject to the exceptions set forth in Clause 12.1: (i) the terms and conditions of this Agreement, for which each Party will be considered a Disclosing Party; (ii) Know How within GW Know How, GW Improvement, *** Know How or *** Improvements, as the case may be, for which the Party which owns such Know How will be considered the Disclosing Party; and (iii) any other non-public information, whether or not patentable, disclosed or provided by one Party to the other Party in connection with this Agreement, including, without limitation, information regarding such Party’s strategy, business plans, objectives, research, technology, products, business affairs or finances and any other information of the type that is customarily considered to be confidential information by parties engaged in activities that are substantially similar to the activities being engaged in by the Parties under this Agreement, for which the Party making such disclosure will be considered the Disclosing Party.

“Consumables” — all consumables required to Produce each Batch, including packaging components.

“Costs” — as defined in Clause 10.1.1.

“Credit Note” — a note to be issued by *** to GW when BRM is rejected pursuant to Clause 5.8. The value stated on the face of such note may be set off against future payments due by GW to *** pursuant to Clause 10. The value of a Credit Note will be calculated as follows:

(a) where BRM Harvested from a Crop of Production Plant of the predominantly delta tetrahydrocannabinol (“THC”) producing Chemovar is rejected the value of the Credit Note shall be:

Value of Credit Note = no. of kg of BRM rejected x K 1

(b) where a Batch of BRM Harvested from a Crop of Production Plant of the predominantly cannabidiol ( “CBD” ) producing Chemovar is rejected the value of the Credit Note shall be:

Value of Credit Note = no. of kg of BRM rejected x K

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Where;

K =£71; and

K 1 =£***

After 1 January 2007, if GW can demonstrate to the satisfaction of *** (acting reasonably) that the value of K and/or K 1 has increased by greater than fifteen percent (15%) from the previously agreed value, such value(s) shall be increased accordingly. Any such increase shall be rounded to the nearest one pound sterling (£l).

“Crop” — *** (***) Units of Production Plants in the Flowering Zone (as defined in the Technical Agreement) grown from Vegetative Plants which were themselves grown from Cuttings taken in a particular week, in all material respects in accordance with the Technical Agreement, or such other number of Units as the Parties may agree from time to time. For clarity, a Crop may contain Production Plants of more than one Chemovar and therefore may provide more than one Batch.

“Cuttings” - a piece of sectioned plant material taken from a Mother Plant, which potted up, can be grown to form a new Vegetative Plant (as applicable).

“Direct Fixed Costs” — as defined in Part B of Schedule 4.

“Direct Growing Costs” — as defined in Part B of Schedule 4.

“Effective Date” — 1 January 2006.

“Facility” — the *** ha (***) area at the Premises set aside for the growth of Plants.

“First Suspension Year” — as defined in Clause 16.1.

“Force Majeure” — in relation to either Party, any event or circumstance which is beyond the reasonable control of that Party which event or circumstance that Party could not reasonably be expected to have taken into account at the date of this Agreement and which results in or causes the failure of that Party to perform any or all of its obligations under this Agreement, including acts of God, lightning, fire, storm, flood, earthquake, accumulation of snow or ice, lack of water arising from weather or environmental problems, strike, lockout or other industrial or student disturbance, act of the public enemy, war declared or undeclared, threat of war, terrorist act, blockade, revolution, riot, insurrection, civil commotion, public demonstration, sabotage, act of vandalism, prevention from or hindrance in obtaining in any way materials, energy or other

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

supplies, explosion, fault or failure of plant or machinery (which could not have been prevented by good industry practice), or legal requirement governing either Party, provided that (a) lack of funds shall not be interpreted as a cause beyond the reasonable control of that Party, and (b) loss or destruction of Plants due to infection or infestation of the Facility by an organism (whether prokaryotic or eukaryotic) which could have been prevented had the Facility been managed in accordance with good industry practice, shall not be interpreted as a cause beyond the reasonable control of that Party.

“Good Agricultural Practices” or “GAP” — the EuroPAM regulatory standards and the principles and guidelines contained in The Guidelines for Good Agricultural Practice (GAP) of Medicinal and Aromatic Plants, in effect from time to time, relating to the Production of BRM.

“Growing Plan” — as defined in Clause 5.1.1.

“Growing Protocol” — the protocol for the Production of the BRM set out in Appendix A to the Technical Agreement as may be amended from time to time.

“GW Improvements” — all Improvements to GW Know How, including the Growing Protocol, the Plants, the BRM or its Production made by *** whilst performing its obligations hereunder, but always excluding Improvements to those aspects of the Growing Protocol that are methods or techniques or standard operating procedures generally available to or used by growers or producers of pot-plants, including ***.

“GW Know How” — all Know How relating to the Plants, the BRM and its Production, owned or controlled by GW at the Effective Date and/or during, the term of this Agreement (including the Growing Protocol), which is necessary for *** to Produce BRM.

“Harvest” , “Harvested” or “Harvesting” — the activity of cutting down a particular Crop ready for drying to Produce BRM; which activity will be performed in all material respects in accordance with the Technical Agreement.

“Harvest Date” — the date calculated in accordance with the Technical Agreement on which a particular Crop is to be Harvested.

“ *** Improvements” — any Improvements to the *** Know How developed by *** whilst performing its obligations hereunder, including improvements to methods, techniques or standard operating procedures generally available to or used by growers or producers of pot-plants, but always excluding GW Improvements.

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“ *** Know How” — all Know How owned or controlled by *** at the Effective Date and relating to Production which will be used by *** in Producing BRM which, for the avoidance of doubt, excludes GW Know How.

“Improvements” — improvements, modifications and/or adaptations to Know How relating to BRM Production, the Growing Protocol, the Plants or the BRM.

“Indirect Fixed Costs” — as defined in Part C of Schedule 4.

“Indirect Operating Costs” — as defined in Part D of Schedule 4.

“Insolvency Event” — in relation to either Party means any one of the following:

(a) a notice shall have been issued to convene a meeting for the purpose of passing a resolution to wind up that Party, or such a resolution shall have been passed other than a resolution for the solvent reconstruction or reorganisation of that Party; or

(b) a resolution shall have been passed by that Party’s directors to seek a winding up or a petition for a winding up shall have been presented against that Party which, in the case of a petition presented against a Party, shall not have been appealed within seven (7) days of having, been lodged or such an order shall have been made and shall have been dismissed within thirty (30) days thereafter; or

(c) a receiver, administrative receiver, receiver and manager, interim receiver, custodian, sequestrator or similar officer is appointed in respect of that Party or an encumbrancer takes steps to enforce or enforces its security which shall not have been dismissed by a court of competent jurisdiction within thirty (30) days thereafter; or

(d) a resolution shall have been passed by that Party or that Party’s directors to make an application for an administration order or to appoint an administrator, or (ii) an application for an administration order shall have been made to the court or a notice of appointment of an administrator shall have been filed at the court in respect of that Party, which in the case of such an application made to the court or notice filed with the court, shall not have been appealed within seven (7) days of having been made or filed or such an order or appointment shall have been dismissed within thirty (30) days thereafter; or

(e) a proposal for a voluntary arrangement shall have been made in relation to that Party under Part I Insolvency Act 1986; or

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(f) a step or event shall have been taken or have arisen outside the United Kingdom which is similar or analogous to any of the steps or events listed at (a) to (e) above; or

(g) that Party takes any step (including starting negotiations) with a view to readjustment, rescheduling or deferral of any part of that Party’s indebtedness, or proposes or makes any general assignment, composition or arrangement with or for the benefit of all or some of that Party’s creditors or makes or suspends or threatens to suspend making payments to all or some of that Party’s creditors or the Party submits to any type of voluntary arrangement; or

(h) where that Party is resident in the United Kingdom it is deemed to be unable to pay its debts within the meaning of Section 123 Insolvency Act 1986.

“Know How” — the technical and other information which is not in the public domain, including information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), processes (including plant generation and growing processes, specifications, methods and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports, manufacturing data or summaries and information contained in submissions to and information from ethical committees and regulatory authorities. Know How includes documents containing. Know How, including but not limited to any rights including trade secrets, copyright, database or design rights protecting such Know How. The fact that an item is known to the public shall not be taken to preclude the possibility that a compilation including the item, and/or a development relating to the item, is not known to the public.

“Laws” — all laws, statutes, rules, regulations, ordinances, guidelines and other pronouncements having the effect of law of any Competent Authority.

“Marketing Authorisation” — the approval granted by a Competent Authority permitting GW to market BDP in a country.

“Mother Plants” — the mother cannabis plants grown and maintained solely for the intention of producing further generations of Cuttings.

“Next Suspension Year” — as defined in Clause 16.2.2.

“Original Production and Supply Agreement” — the production and supply agreement dated 16 May 2003 between the Parties.

“Other GW Internal Specifications” — any specifications applicable to BRM, BDS or BDP other than the BRM Specifications.

“Packing Date” — the date on which a Batch of BRM is packaged and labelled ready for delivery.

“Partner(s)” — third parties with whom GW has entered into a collaboration or licence in relation to the Commercialisation of BDP.

“Party” or “Parties” — GW and/or ***.

“Plants” — all cannabis plants (including “Cuttings”, “Vegetative Plants”, “Production Plants” or “Mother Plants”) irrespective of their intended use.

“Premises” — *** nursery at ***.

“Production” — the activities relating to purchasing, planting, propagation, cultivation, maintenance, Harvesting, drying, packing, QC, release, storage, shipment and supply of the BRM specified in the Technical Agreement and “Product” and “Produce” shall be interpreted accordingly.

“Production Plants” — all cannabis plants grown solely for the purpose of flowering to produce the BRM.

“Regulatory Approval” — any manufacturing or other licence required by *** to grow the Plants and Produce BRM, including any licence or authorisation to Produce BRM as granted by the relevant Competent Authorities equivalent to and including without limitation the “Home Office Licence to Produce, Supply and Possess”.

“Release” — the mechanism by which each Batch is deemed to conform in all material respects with the BRM Specifications (including in accordance with GAP). Release is demonstrated by issue of a Certificate of Release.

“Responsible Person” — an employee of GW or FIG, as the case may be, who is listed in the Technical Agreement and is responsible for compliance of the BRM with current Good Agricultural Practice, the BRM Specification and other requirements of applicable Laws, or any other Responsible Person who is his or her designee.

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“Retail Prices Index” or “RPI” — the index of all prices published as the Retail Prices Index by the UK Office of National Statistics and, if the RPI is no longer published the nearest equivalent to the RPI shall be used.

“Supplier Non-Conformity/Reject Note” — a certificate (as more fully defined in the Technical Agreement) issued by GW, which (i) when issued by GW pursuant to Clause 5.8.1 formally indicates to *** an incidence of non-conformance of a Batch in any material respect with the BRM Specifications, or (ii) when issued by GW pursuant to Clause 5.8.2 formally indicates to *** an incidence of non-conformance of a Batch in any material respect with other Internal GW Specifications, where GW reasonably believes that the non-conformity has arisen from a failure on the part of *** to meet its obligations under the Growing Protocol in any material respect.

“Suspension Costs” — as defined in Clause 16.2.

“Suspension Date” — as defined in Clause 16.1.

“Suspension Year” — as defined in Clause 16.1.

“Technical Agreement” — the technical agreement between the Parties in effect at the Effective Date which specifies the respective responsibilities of the Parties relating to the cultivation and control of BRM as may be amended from time to time by the Parties in writing.

“Term” — as defined in Clause 15.

“Unit” — a bench of Production Plants measuring approximately 10m 2 .

“Vegetative Plants” — all Plants to be maintained in long day length to prevent flowering. Such plants may be induced to flower (i.e. produce Production Plants) or maintained in the vegetative state to Produce Mother Plants.

“Wages and Salaries” — as defined in Part E of Schedule 4.

“Wind-Down Period” — as defined in Clause 16.1.

1.2 Interpretation

1.2.1 Unless otherwise stated, a reference to a Clause or Schedule is a reference to a clause of, or schedule to, this Agreement.

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1.2.2 Clause headings are for ease of reference only and do not affect the construction of this Agreement.

1.2.3 References in this Agreement to any statute or statutory provision or EU Directive or Regulation shall include any statute or statutory provision or EU Directive or Regulation which amends, extends, consolidates or replaces the same (whether before or after the date hereof) or which has been amended, extended, consolidated or replaced by the same and shall include any order, regulation, instrument or other subordinate legislation made under the relevant statute or statutory provision or EU Directive or Regulation.

1.2.4 References to the singular shall be deemed to include the plural and vice versa.

1.2.5 Reference to a person includes any person, firm, partnership, association or body corporate.

2. TERMINATION OF PRE-EXISTING ARRANGEMENTS BETWEEN THE PARTIES

2.1 The Parties agree that, with effect from the Effective Date, the Original Production and Supply Agreement and the Commercial Heads of Terms shall terminate and shall be replaced by this Agreement. Any outstanding obligations of either Party under either the Original Production and Supply Agreement or the Commercial Heads of Terms are superseded by the terms of this Agreement.

3. APPOINTMENT

3.1 Subject to Clause 3.2, GW hereby appoints *** as its sole external supplier of BRM for use in the production of BDS for inclusion in BDP for the Term. Such BRM shall only be Produced at and supplied from the Facility. *** acknowledges that GW may continue to use supplies of BRM derived from cannabis growing facilities owned by GW or any Affiliate of GW. For the avoidance of doubt GW shall not during the. Term source BRM from any third party for use in the production of BDS for inclusion in BDP except an Affiliate of GW.

3.2 In the event of the occurrence of any of the events in Clause 3.3 GW shall be entitled (upon not less than four (4) month’s notice to ***) to convert ***’s appointment as GW’s sole external

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supplier of BRM pursuant to Clause 3.1 to a non-exclusive appointment. It shall be at GW’s sole discretion whether to give such a notice.

3.3 The events referred to in Clause 3.2 are:

3.3.1 a Partner requiring GW to establish a second commercial source or supplier of BRM, in which case GW shall be permitted to appoint a third party as a second commercial supplier (a “Second Source” ) so long as GW ensures that the terms of the appointment of such Second Source are such that GW will only source BRM from the Second Source when this Agreement has terminated or *** is otherwise unable to supply GW with all its requirements for BRM. In any event, should a Partner require GW to establish a Second Source GW shall promptly inform *** of this fact and shall provide to *** in writing full details of the services required of the Second Source. *** shall, within thirty (30) days of receipt of such notice, inform GW in writing of whether it is interested in pursuing negotiations with regard to providing the services required of the Second Source. During such thirty (30) day period GW shall have no negotiations with any third party about being the Second Source. If *** rejects the opportunity to negotiate for the right to be appointed as the Second Source (or does not respond within such thirty (30) day period) GW shall be under no further obligation to *** in relation thereto. If *** wishes to enter negotiations the Parties shall in good faith seek to negotiate, agree and execute an agreement under which *** will be appointed as the Second Source. If after a period of one hundred and twenty (120) days from the date of *** receipt of GW’s notice the Parties have failed to execute an agreement or otherwise agree binding and enforceable terms, GW shall be free to enter into and conclude negotiations with third parties with regard to the appointment of a Second Source;

3.3.2 with regard to the United States of America, its territories and possessions (the “USA” ), if for any reason GW desires to establish a facility in the USA for the Production of BRM for use in the production of BDS for inclusion in BDP for the market in the USA. Should GW desire to establish a BRM Production facility in the USA GW shall inform *** of this fact at the same time as it informs third parties of this fact and shall provide to *** in writing full details of the required facility and associated services at the same time as it gives such information to any third party so as to allow *** to bid for the right to establish such a facility in the USA for the Production of BRM for use in the production of BDS for inclusion in BDP for the market in the USA on the same basis as any third party;

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3.3.3 GW’s demand for BRM for use in the production of BDS for inclusion in BDP exceeds the maximum BRM Production capability of the Facility;

3.3.4 *** either (i) fails to deliver BRM which has been Produced in all material respects in accordance with the Technical Agreement for a period in excess thirty (30) days, or fails to deliver BRM which has been Produced in all material respects in accordance with the Technical Agreement on three (3) or more separate occasions in any twelve (12) month period, and in either case such failure to deliver is caused by or results from the default of *** in complying with its obligations under this Agreement SAVE AND EXCEPT where (in either case) *** can demonstrate to GW’s satisfaction (acting reasonably) that *** is using its best endeavours to resolve the issue causing its failure to deliver.

4. KNOW-HOW TRANSFER/SUPPLY OF PLANTS

4.1 GW shall on the Effective Date (to the extent it has not already done so) give full disclosure to *** of all GW Know How, thereafter from time to time GW shall (i) provide to *** such technical advice and guidance from GW employees and or representatives (as appropriate) as *** may reasonably request and at times to be agreed by the Parties for the purpose of understanding the GW Know How relating to Production transferred to ***; and (ii) supply or shall arrange the supply to *** of the quantities of Plants (including Cuttings) as *** may reasonably request and at times to be agreed.

4.2 If *** at any time believes GW to be in default of its obligations under Clause 4.1 giving rise to circumstances which excuse ***’s performance under this Agreement *** shall give prompt written notice of this fault to GW giving reason for this belief (each such notice containing details of such facts) failing which *** shall not be entitled to rely on any such default by GW to excuse ***’s performance.

4.3 GW permits *** to use the Consumables purchased by *** under the Commercial Heads of Terms and owned by GW during Production.

5. PRODUCTION, DELIVERY AND ACCEPTANCE

5.1 With effect from the week commencing 2 January 2006 *** shall take Cuttings and pot up one Crop of Production Plants per week and shall cultivate such Crop in all material respects in

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accordance with the Growing Protocol. Upon each Harvest Date *** shall Harvest that Crop and complete the Production of Batches therefrom. *** shall Produce Batches of BRM from each Crop from 10 April 2006 onwards unless otherwise agreed by the Parties.

5.1.1 The precise proportions of Chemovars within each Crop shall be determined through the production planning mechanism set out in Schedule 1 through which GW will, on a monthly basis, provide *** with a Production forecast ( “Growing Plan” ) covering, as a minim the following twelve (12) months.GW shall give *** reasonable notice of changes to any Growing Plan. *** shall use reasonable endeavours to comply with any changes to a Growing Plan requested by GW.

5.2 In the event *** experiences failure or delay in the Production of a Batch, *** shall promptly inform GW of this failure or delay and the Parties shall, within ten (10) Business Days thereof meet and discuss the cause of such failure/delay and agree a plan to mitigate the effects of such failure/delay. In the event *** is unable to deliver BRM which has been Produced in accordance with the Technical Agreement for a period in excess of thirty (30) days and such failure to deliver is caused by or results from the default of *** in complying with its obligations under this Agreement (which shall exclude any failure resulting from the default of GW or Force Majeure), GW reserves the right to cease all payments to *** pursuant to Clause 10 until either *** remedies such failure or (if earlier) the Agreement is terminated.

5.3 *** shall notify GW in writing of each Packing Date within five (5) Business Days of it occurring and provided that the foregoing notification was duly given *** shall deliver each Batch within ten (10) weeks from such Packing Date. The actual delivery dates shall be mutually agreed between the Parties taking into account ***’s actual storage capacity.

5.4 Prior to delivery of any Batch, *** will supply to the Responsible Person at GW all pre-despatch documents specified in the Technical Agreement. Each Batch of BRM shall be delivered to GW’s designated carrier on an ex-works basis (Incoterms 2000) from ***’s Premises in its entirety (except for agreed samples) and shall be accompanied by all documentation necessary to comply with the Regulatory Approvals. Upon arrival at GW’s premises, GW will complete all necessary documents to comply with controlled drugs legislation and *** will complete all post-despatch documents in accordance with the requirements of the Technical Agreement. Title and risk of damage and loss shall pass to GW upon delivery of each Batch to GW’s designated carrier, and GW shall be responsible for all costs of shipping, taxes, insurance, warehousing and other similar or related costs after delivery.

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5.5 When performing Production *** shall comply in all material respects with the Technical Agreement.

5.6 *** shall package, label and store the BRM appropriately for delivery to GW in all material respects in accordance with the requirements of the Technical Agreement, and the reasonable instructions of GW. *** shall ensure that appropriate storage conditions are met until delivery.

5.7 *** shall not he permitted subcontract any agreement save as set out in Clause 17.13.

5.8 Acceptance:

5.8.1 GW or GW’s representative shall examine each Batch and the documentation delivered with each Batch pursuant to Clause 5.5 as soon as practicable following arrival at GW’s or its nominee’s premises. Within ten (10) days of delivery of each Batch GW shall send *** a Supplier Non-Conformity/Reject Note containing details of any failure of the Batch to meet the BRM Specifications which are apparent on reasonable inspection. If *** has not received a Supplier Non-Conformity/Reject Note within twelve (12) days of delivery the Batch shall be deemed to have been delivered complete and undamaged and (in respect of any defect apparent on reasonable inspection) in compliance with the BRM Specifications. In the event that GW gives *** a Supplier Non-Conformity/Reject Note in relation to any Batch GW shall make available such material to *** for inspection by ***. If following such inspection by *** (which shall take place within thirty (30) days of such BRM being made available to ***) it is agreed by *** that the Batch is not in compliance with the may test each Batch in advance of delivery at ***’s own cost and expense to ensure they will meet the requirements of the BRM Specifications.

5.8.2 Thereafter, if within six (6) months of the delivery date for a Batch: (a) the results of GW’s analysis of a Batch shows a non-conformance to any Other Internal GW Specifications and GW has reasonable cause to believe that this has arisen from a failure on the part of *** to meet its obligations in any material respect under the Technical Agreement (such belief to be supported by documented evidence including a copy of the results of the laboratory analysis of the batch in question showing the non-conformance to the Other Internal GW Specifications) then GW shall give *** a Supplier Non-Conformity/Reject Note within twenty five (25) days of receipt of such analysis and shall at ***’s expense make available such material to *** for further testing. If following such further testing by *** and following investigation by *** of all available site records in relation to the Batch (which shall take place within thirty (30) days of such BRM being made available to ***) it is agreed by *** that the Batch was not Produced in accordance

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with the Technical Agreement *** shall issue to GW a Credit Note for the BRM in that Batch. For clarity so long as the results of GW’s analysis of a Batch are received by GW within six (6) months of delivery of the relevant Batch and the Supplier Non-Conformity/Reject Note is served on *** within twenty five (25) days after GW’s receipt of the results of such analysis such Supplier Non-Conformity/Reject Note shall be valid even if delivered after six (6) months of the delivery date so long as the other requirements of this Clause 5.8.2 have been complied with.

5.8.3 If after *** has carried out the inspection envisaged in Clause 5.8.1 above or the further testing envisaged in Clause 5.8.2 above *** disagrees with GW’s view that on delivery the Batch failed to conform in all material respects to the BRM Specifications and/or that it was not Produced in all material respects in accordance with the Technical Agreement, and therefore there is a dispute between the Parties relating thereto, then either: (i) *** shall promptly send a sample of the Batch in question to an independent testing laboratory to be appointed by agreement between GW and *** (such agreement to be reached expeditiously), or (ii) where appropriate, the Parties shall appoint an independent expert ( “Expert” ) to investigate compliance with the BRM Specifications and Technical Agreement. If the Parties elect to send the sample to an independent laboratory, the costs of such independent testing laboratory shall be borne equally between GW and ***. The decision of such independent testing laboratory shall be in writing and, save for manifest error on the face of decision, shall be binding on both GW and ***. If the Parties elect to resolve the issue by Expert determination, the Expert shall be engaged on the teens set out in Schedule 2.

5.8.4 Any Batch that, as a result of the procedures set out in Clauses 5.8.1 to 5.8.3 is found to have been Produced other than in compliance with the BRM Specifications or the Technical Agreement shall be destroyed by GW at ***’s reasonable expense.

5.8.5 If GW fails to notify *** of its return of a Batch within the time limits set out in Clauses 5.8.1 to 5.8.2 GW shall not be entitled to return the BRM concerned and *** shall have no liability for any defect in such Batch save as set out in Clause 13.6 and GW shall not be entitled to a Credit Note with regard to that Batch.

5.8.6 Should any Batch fail to meet any Other Internal GW Specifications, whether or not such Batch is believed to have been Produced in all material respects in accordance with the Technical Agreement, the Parties shall, where requested by GW, meet within thirty (30) days of the date of GW issuing the Supplier Non Conformity/Reject Note or otherwise notifying *** of the non-conformity to discuss the circumstances as to why such Batch

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did not meet the Other Internal GW Specifications and what changes to the Growing Protocol are required (if any) to prevent these circumstances occurring again. For the avoidance of doubt in the circumstances envisaged in this sub-clause 5.8.6 the occurrence of a meeting to discuss the non-conformity of a Batch to Other Internal GW Specifications shall not in itself raise the implications: (a) that GW is entitled to issue a Supplier Non-Conformity/Reject Note with regard to the Batch in question; (b) that *** has any liability for the non-conformity or other defect in such Batch; or (c) that GW is entitled to a Credit Note with regard to that Batch, but should the meeting result in the disclosure of information that shows that a Batch failed to meet any Other Internal GW Specifications due to it being Produced otherwise than in accordance with the Technical Agreement GW may still give *** a Supplier Non-Conformity/Reject Note if permitted to do so under the terms of Clause 5.8.2.

6. INSPECTIONS AND AUDITS

6.1 GW shall, at its own expense, have the right from time to time to assign a reasonable number of its employees or representatives (including. employees or representatives of a Partner) to be present at the Premises where BRM is Produced to inspect, discuss and review all activities being undertaken by or on behalf of *** in relation to the Production of BRM. Prior to inspecting the Premises, each employee or representative of GW who shall be performing the inspection of the Premises (including employees or representatives of a Partner) shall execute a confidentiality agreement naming *** as a beneficiary in the form to be provided by ***. In addition such employees and representatives shall, while at the Premises (a) observe and comply with ***’s safety, facility access, and other customary regulations and policies, and (b) not access areas of the Premises for which they are not expressly authorised by ***.

6.2 *** shall notify GW within three (3) Business Days after it has been notified of any inquiries, notifications, or inspection activity by any Competent Authority relating to BRM as detailed in the Technical Agreement. *** shall provide a reasonable description to GW of any such inquiries, notifications or inspections promptly (but in no event later than ten (10) days after such inquiry, notification, or inspection).

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7. INFORMATION SHARING

7.1 *** shall inform GW of all reportable incidences in accordance with the terms of the Technical Agreement in writing, as soon as possible from the time it becomes reportable and in any event within the time period specified in the Technical Agreement.

7.2 Each Party shall keep the other Party informed, commencing within (2) Business Days of notification of any action by, or notification or other information which it receives (directly or indirectly) from any Competent Authority, which (a) raises material concerns regarding the safety or efficacy of the BRM, or (b) which indicates or suggests a potential material liability for either Party to third parties arising in connection with BRM.

8. DOCUMENTATION, RECORDS AND PERMITS

8.1 *** shall obtain and maintain all Regulatory Approvals necessary to Produce BRM in accordance with the Technical Agreement.

8.2 *** shall prepare and maintain the Batch Records and all other documentation relating to Production of BRM in all material respects in accordance with the terms of the Technical Agreement.

8.3 *** shall safely store and archive all records relating to BRM Production in accordance with the requirements of the Technical Agreement. In the event GW wishes the Batch Records to be retained by *** beyond the time period set out in the Technical Agreement, *** may charge GW a standard annual storage fee for the retention of such Batch Records at a price to be agreed in advance by both Parties.

9. FURTHER RIGHTS, OBLIGATIONS AND RESPONSIBILITIES

The following rights, obligations and responsibilities shall also apply:

9.1 Either Party may suggest amendments to the BRM Specifications (including the Growing Protocol) at any time in accordance with Change Control (as defined in accordance with the requirements of the Technical Agreement) procedure set out in the Technical Agreement. The Parties shall discuss such proposed changes in good faith, but should the Parties fail to agree on such changes or should such amendment be required due to a change in Law GW shall have the final decision. GW will supply *** with a copy of any amended version of the BRM

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Specifications at the time of issue. GW shall promptly notify *** of the effective date of any such amendment (subject always to giving not less than one (1) month’s prior written notice). To the extent that such amendment results in an increase in the cost of Production the Parties shall, in good faith, examine and agree upon the financial consequences thereof and shall make appropriate adjustments to the Budget for Costs set pursuant to Clause 10.1 for the year in question.

9.2 GW shall keep *** reasonably informed in writing as to the progress of clinical trials and the progress of regulatory approvals related to obtaining Marketing Authorisations for the Products.

9.3 A list of key personnel for both GW and ***, together with specimens of their signatures are presented in Appendix G of the Technical Agreement. Both Parties shall keep each other informed in writing as to changes in such key personnel from time to time.

9.4 During the Term, the key personnel of *** named in Appendix G of the Technical Agreement from time to time for whom GW is reimbursing to *** all of their salary through the payment of Costs (namely the Project Manager and the Crop Manager) and such other employees of *** from time to time for whom GW is reimbursing *** all of their salary through the payment of Costs, will dedicate all of their contracted working hours to BRM Production and will not be allocated responsibilities on or asked to contribute to any other project or programme within ***.

10. CONSIDERATION

10.1 In consideration of *** supplying GW with BRM on the terms set out herein GW shall compensate *** as follows:

10.1.1 GW shall reimburse to *** all ***’s costs, both direct and indirect, incurred in the performance of its obligations hereunder, including but not limited to all cost of the Consumables, Facilities, equipment, insurance and staff as are necessary to perform its obligations hereunder ( “Costs” ). ***’s agreed budget for Costs ( “Budget for Costs” ) for the year 1 January 2007 to 31 December 2007 is set out in Schedule 3 hereto, and each Party shall use reasonable endeavours to agree a Budget for Costs for successive calendar years during the term of this Agreement in accordance with the procedures set out in this Clause 10.1.1. On or before 1 November 2007 and 1 November in each subsequent calendar year during the term of this Agreement *** shall submit to GW its draft Budget for Costs for the coming calendar year. Within fifteen (15) days thereof the Parties shall meet to discuss and agree the Budget for Costs for the upcoming calendar year.The

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Budget for Costs shall be agreed by 30 November thereafter. If, for some reason, *** requires a change to the Budget for Costs for a specific calendar year, *** shall present GW with evidence for the requested change and the Parties shall discuss the changes to the budget in good faith. Any change to a Budget for Costs will only be binding when a revised Budget for Costs is signed by both Parties.

10.1.2 In addition to reimbursing to *** its Costs GW shall also pay *** a price per unit area of Production of *** per annum, save that for the period from 1 January 2006 to 12 February 2006 the price per unit area of Production which GW will pay to *** shall be *** per annum. The applicable unit area of Production for these purposes shall be deemed to be the entire area of the Facility (***). All sums due pursuant to this Clause 10.1.2 shall be payable in monthly instalments to be invoiced monthly in arrears. The applicable price per unit area shall be increased annually in line with inflation for the first three years of this Agreement (specifically from January 2006 until December 2008 with the first adjustment being made to the first invoice raised in January 2007). Beyond December 2008 no further indexation shall apply. The increase in price per unit area shall be calculated as follows:

(a) On the 1 January each year, commencing with 1 January 2007, the relevant price per unit area will be increased by multiplying the price per unit area applicable on the 31 December in the previous year by the fraction NewRPI/OldRPI, where the NewRPI is the Retail Prices Index for the calendar quarter which ended on 31 December immediately preceding the 1 January on which the adjustment is being made and OldRPI is the Retail Prices Index for the calendar quarter which ended on 31 December twelve months prior to the 1 January on which the adjustment is being made. Any such increase shall be rounded to two (2) decimal points.

10.1.3 For clarity, under Clause 10.1.1 GW shall reimburse to *** any depreciation costs on capital expenditure actually made on equipment to be used solely at the Facility or the Facility itself during the term of this Agreement (“Dedicated Capital Expenditure” ). Where such Dedicated Capital Expenditure on a single item shall exceed one thousand pounds (£1,000), *** shall not incur such Dedicated Capital Expenditure without the prior written consent of GW. Where Dedicated Capital Expenditure is incurred during the term of this Agreement, such expenditure shall be depreciated across the shorter of (a) the life of the asset in question agreed between the Parties, or (b) the remaining term of the Agreement, and such Dedicated Capital Expenditure shall be reimbursed to *** in equal monthly instalments across such period.

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10.2 *** shall supply to GW within thirty (30) days of the end of each calendar month after the Effective Date an itemised and adequately documented summary of its actual monthly Costs for that month and a monthly invoice for the sums due in accordance with Clause 10.1.2. For clarity *** shall not invoice GW for a Cost which is not in the Budget for Costs without the prior consent of GW (such consent not to be unreasonably withheld or delayed).

10.3 *** shall keep full, true and accurate records and books of account containing all particulars that may be necessary for the purpose of calculating all sums payable by GW under this Agreement for a minimum period of four (4) years. Upon timely requests by GW, GW shall have the right to inspect such records and books of account to ensure that *** has been invoiced only for the sums properly payable by it under this Agreement

10.4 Should GW’s inspection pursuant to Clause 10.3 reasonably lead GW to believe that it has not been invoiced only for the sums property payable by it under this Agreement, upon timely request by GW, GW shall have the right to instruct an independent, internationally recognized, accounting firm to perform an audit, conducted so far as appropriate in accordance with standard UK accounting practice, as is reasonably necessary to enable such accounting firm to report to GW that GW has been invoiced for the sums properly payable by it under this Agreement on the following basis:

10.4.1 such firm of accountants shall be given access to and shall be permitted to examine and copy such books and records upon twenty (20) Business Days notice having been given by GW and at all reasonable times on Business Days for the purpose of certifying to GW that the Costs, capital expenditure depreciation and other payment calculated and invoiced by *** during any calendar year were calculated correctly in accordance with this Agreement (and if such certification cannot be given specifying the reasons why which will enable the Parties to recalculate the relevant sums);

10.4.2 prior to any such examination taking place, such firm of accountants shall undertake to *** that they shall keep all information and data contained in such books and records, strictly confidential and shall not disclose such information or copies of such books and records to any third person including GW, but shall only use the same for the purpose of the reviews and/or calculations which they need to perform in order to issue the certificate to GW which this Clause 10.4 envisages;

10.4.3 any such access examination and certification shall occur no more frequently than once per calendar year and will not go back over records more than seven (7) years old unless a discrepancy is found;

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10.4.4 *** shall make available personnel to answer queries on all books and records required for the purpose of that certification;

10.5 If the certification is in disagreement with the invoices submitted by ***, *** shall notify GW within ten (10) days of receipt by *** of the certification whether or not *** agrees within the certification. If *** notifies its agreement with the certification within the ten (10) day period or fails to give any notification within that period, the sums calculated by the certification shall be used for purposes of calculating any monies owed and any monies owed by *** to GW shall be paid by ***. The cost of the accountant shall be the responsibility of *** if the recalculation shows that ***’s invoices for the year in question supplied to GW to be inaccurate by more than the lesser of ten thousand pounds sterling. (£10,000) or five per cent (5%) of the amount actually invoiced and the responsibility of GW otherwise. If *** notifies its disagreement with the certification, either Party may refer the items in dispute to a partner of at least 10 years qualified experience at an independent, internationally recognized, public accounting firm agreed by the Parties in writing for final and binding resolution, or failing agreement on the identity of the public accounting firm within fifteen (15) days starting on the day after receipt of the notification of disagreement, an independent, internationally recognized, public accounting firm appointed on the application of either Party by the President for the time being of the Institute of Chartered Accountants of England and Wales. Such person appointed shall act on the following basis:

10.5.1 such person shall act as an expert and not as an arbitrator;

10.5.2 such person’s terms of reference shall be to determine the matters in dispute within 20 days of his appointment;

10.5.3 the Parties shall each provide such person with all information relating to the items in dispute which such person reasonably requires and such person shall be entitled (to the extent he considers appropriate) to base his determination on such information;

10.5.4 the decision of such person is, in the absence of fraud or manifest error, final and binding on the Parties; and

10.5.5 such person’s costs shall be paid by *** and/or GW as such person may determine.

10.6 All payments to be made under the terms of the Agreement are expressed to be exclusive of value added tax howsoever arising and GW shall pay to ***, in addition to the invoiced amount, all value added tax for which *** is liable to account in relation to any supply made or deemed to be made for value added tax purposes on receipt of a tax invoice or invoices therefore from ***.

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10.7 GW shall make each payment due within thirty (30) days of the date of each invoice therefore.

10.8 Save for Credit Notes issued pursuant to Clause 5.8, all payments under this Agreement shall be made free and clear and without any set off, deduction or deferment in respect of any disputes or claims whatsoever unless required by law of any Competent Authority or unless GW has a valid court order requiring an amount equal to such deduction to be paid by *** to GW.

10.9 The time of payment of amounts due to *** under this Agreement is of the essence.

10.10 Payments shall be made by electronic wire transfer of immediately available funds directly to the account of *** designated by *** in writing from time to time.

10.11 If GW fails to make any payment to *** hereunder on the due date for payment and the payment is either (i) not in dispute between the Parties, or (ii) the payment is disputed by GW and GW has given *** notice of the disputed amount it is withholding and an explanation as to why that amount is disputed and the dispute has not been resolved, without prejudice to any other right or remedy available to ***, *** shall be entitled to charge GW interest (both before and after judgment) on the amount unpaid at the annual rate of LIBOR plus four per cent (4%) calculated on a daily basis until payment in full is made without prejudice to ***’s right to receive payment on the due date.

11. INTELLECTUAL PROPERTY

11.1 GW hereby grants to *** as a manufacturer on behalf of GW a royalty-free, non-exclusive right and licence to use GW Know How, together with any GW Improvements, solely for the purpose of performing ***’s obligations under this Agreement and for the term of this Agreement. *** shall otherwise obtain no right title or interest in or to the GW Know How or GW Improvements as a result of this Agreement. For clarity, all Plants shall remain the property of GW.

11.2 Title to and property in GW Improvements and any Know How embodying the same shall vest in GW. *** shall disclose all such GW Improvements promptly to GW following their development. *** shall do all such acts and things and shall execute all such deeds and documents as GW may from time to time require to vest the full right, title and interest in the GW Improvements to GW.

11.3 Title to and property in all *** Know How and *** Improvements and any Know How embodying the same (the “*** Technology” ) shall vest in ***. *** hereby grants GW an irrevocable (subject to Clause 15.4) non-sublicensable, non-exclusive licence to use the *** Technology solely for the purpose of producing BRM at its own growing facility.

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11.4 No *** Improvements or GW Improvements shall be employed by *** in the Production of BRM unless this has been previously agreed pursuant to the mechanism set out in Clause 9.1.

11.5 If any infringement of any such intellectual property comes to the notice of the non-owner, that Party shall promptly inform the owner of such infringements and shall assist the owner at the cost and expense of the owner in taking steps necessary to protect the owner’s rights in relation thereto.

12. CONFIDENTIALITY

12.1 Except to the extent expressly authorised by this Agreement including in Clauses 12.2 and 12.3 or otherwise agreed in writing, each party in possession of Confidential Information ( “Receiving Party” ) of the other Party ( “Disclosing Party” ) shall maintain such Confidential information as confidential and use it only for the purposes of this Agreement in accordance with this Clause 12. The term of maintaining confidentiality of all such information and the limitations on use shall be for a period equal to the longer of (i) five (5) years after the date of expiration or termination of this Agreement; or (ii) for so long as the exceptions set out below in the next subsequent paragraph do not apply to the relevant Confidential Information. Each party shall guard such Confidential Information using the same degree of care as it normally uses to guard its own confidential, proprietary information of like importance, but in any event no less than reasonable care.

Notwithstanding the foregoing, the Receiving Party shall be relieved of the confidentiality and limited use obligations of this Agreement to the extent that the Receiving Party establishes by written evidence that:

12.1.1 the Confidential Information was previously known to the Receiving Party from sources other than the Disclosing Party at the time of disclosure and other than under an obligation of confidentiality;

12.1.2 the Confidential Information was generally available to the public or otherwise part of the public domain at the time of its disclosure; or

12.1.3 the Confidential Information became generally available to the public or otherwise part of the public domain after its disclosure to the Receiving Party other than through any act or omission of the Receiving Party in breach of this Agreement; or

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12.1.4 the Confidential Information is acquired in good faith in the future by the Receiving Party from a third party who has a lawful right to disclose such information and who is not under an obligation of confidence to the Disclosing Party with respect to such information; or

12.1.5 the Confidential Information is subsequently developed by or on behalf of the Receiving Party without use of the Disclosing Party’s Confidential Information.

12.2 Notwithstanding the above obligations of confidentiality and non-use a Receiving Party may:

12.2.1 disclose Confidential Information to a Regulatory Authority as reasonably necessary to obtain regulatory approval in a particular jurisdiction to the extent consistent with the licenses granted under terms of this Agreement;

12.2.2 disclose Confidential Information: (i) to the extent such disclosure is reasonably necessary to comply with the order of a court; or (ii) to the extent such disclosure is required to comply with an applicable Law, including to the extent such disclosure is required in publicly filed financial statements or other public statements under stock exchange rules (e.g., the rules of the U.S. Securities and Exchange Commission, NASDAQ, NYSE, UKLA or any other stock exchange on which securities issued by either Party may be listed); provided, to the extent possible bearing in mind such Legal Requirements and subject to the next subsequent sentence of this Clause 12.2.2, such Party shall provide the other Party with a copy of the proposed text of such statements or disclosure five (5) Business Days in advance of the date on which the disclosure is to be made to review and provide comments, unless a shorter review time is agreed. If the compliance with the disclosure requirements of a securities exchange or its regulatory body requires filing of this Agreement, the filing Party shall seek confidential treatment of portions of this Agreement from the securities exchange or body and shall provide the other Party with a copy of the proposed filings at least ten (10) Business Days prior to filing for the other Party to review any such proposed filing. Each Party agrees that it will obtain its own legal advice with regard to its compliance with securities laws and regulations, and will not rely on any statements made by the other Party relating to such securities laws and regulations;

12.2.3 disclose Confidential Information to such Receiving Party’s employees, Affiliates, distributors, licensees, Partners, agents, consultants, clinical investigators, collaborators or contractors as such Receiving Party reasonably determines is necessary to receive the benefits of the licences to it under this Agreement or to perform its obligations pursuant

to this Agreement; provided, however, any such persons must be obligated to substantially the same extent as set forth in Clause 12.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement.

12.2.4 disclose Confidential Information: (i) to its actual or potential investment bankers and to lenders for the purpose of obtaining financing for its business; (ii) to potential investors in connection with an offering or placement of securities for purposes of obtaining financing for its business; and (iii) to bona fide potential acquirer or merger partner for the purposes of evaluating entering into a merger or acquisition, provided, however, any such persons must be obligated to substantially the same extent as set forth in Clause 12.1 to hold in confidence and not make use of such Confidential Information for any purpose other than those permitted by this Agreement;

12.2.5 nothing in this Clause 12 restricts either Party from using or disclosing any of its own Confidential Information for any purpose whatsoever.

12.3 Save as permitted in Clause 12.2, neither Party shall make any public announcement or statement to the public containing Confidential Information without the prior consent of the other. All such public announcements or statements shall not be made without the prior review and consent of appropriate individual designated for the purpose by the other Party.

13. WARRANTIES AND LIABILITY

13.1 *** warrants that:

13.1.1 it has the right to enter into this Agreement;

13.1.2 it will perform its obligations hereunder with reasonable skill and care;

13.1.3 each Batch shall be delivered free of encumbrances and liens; and

13.1.4 the BRM shall be Produced in all material respects to the BRM Specifications unless otherwise agreed in writing by both Parties.

13.2 GW warrants that:

13.2.1 it has the right to enter into this Agreement; and

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13.2.2 it holds all necessary rights and licenses to GW Know How to allow *** to Produce BRM; and

13.2.3 no claim or litigation has been brought or threatened by any person alleging that the disclosing, copying, making, licensing, using or exploiting of GW Know How violates, infringes or otherwise conflicts or interferes with any intellectual property or proprietary right of any other person; and

13.2.4 to the best of its knowledge, not having undertaken any detailed freedom to operate or other searches, the use by *** of the GW Know How or GW Improvements for any activity contemplated under this Agreement shall not violate, infringe or otherwise conflict or interfere with any intellectual property or proprietary right of any other person existing at the Effective Date.

13.3 Except as and to the extent specifically provided in this Clause 13 or in any other provision of this Agreement, *** and GW make no representations or warranties of any kind, express or implied, with respect to the subject matter of this Agreement, and each Party specifically disclaims and waives all other representations, warranties and conditions, including without limitation all implied conditions of merchantability and fitness for a particular purpose. *** and GW warranties are made only to *** and GW, respectively, and do not extend to any third party.

13.4 Subject to Clauses 13.5 to 13.7 and except in the case of fraudulent misrepresentation:

13.4.1 neither Party shall be liable to the other in contract, tort (including negligence) breach of statutory duty, misrepresentation or otherwise for any loss, damage, costs or expenses of any nature whatsoever incurred or suffered by the other or its Affiliates:

(a) of a direct nature where the same is a loss of turnover, profits, business or goodwill; or

(b) of an indirect or consequential or punitive nature, including any indirect or consequential economic loss or other indirect or consequential loss of turnover, profits, loss of enterprise value, loss of business or loss of goodwill, loss of savings, costs or expense of obtaining alternative goods or services, loss of contract or otherwise, and

13.4.2 each Party’s entire liability in respect of all claims arising out of or in connection with this Agreement in any calendar year shall not exceed one million pounds (£1,000,000).

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13.5 Each Party accepts liability for death or personal injury resulting from its negligence.

13.6 *** shall indemnify and hold GW, and its directors, officers and employees ( “GW Indemnified Parties” ) harmless from and against all claims, liabilities, judgements and other costs (including, but not limited to, reasonable attorney fees and expenses incurred in investigating, defending and settling claims and in enforcing GW’s obligations under this Clause 13.6) (collectively “Liabilities” ) of any kind resulting from any claims, suits or demands brought by persons other than the GW Indemnified Parties based on actual or alleged bodily injury or death resulting from the use of BDP containing BDS extracted from BRM supplied by *** where it is proved that such BRM did not meet the BRM Specifications at the time of delivery or had not been Produced in accordance with the Technical Agreement. For clarity, *** shall have no liability to GW for bodily injury or death resulting from either: (i) the use of BDP containing BDS extracted from BRM supplied other than by ***; or (ii) defects in BDP or BDS where the cause of such defect is not related to the Production and supply of BRM by *** hereunder, including (by way of a non-limiting example) where the defect arises during the process of extracting BDS from BRM supplied by *** where such BRM was supplied by *** in accordance with the terms of this Agreement and the Technical Agreement.

13.7 GW shall indemnify and hold ***, and its directors, officers and employees ( “*** Indemnified Parties” ) harmless from and against all claims, liabilities, judgements and other costs (including, but not limited to, reasonable attorney fees and expenses incurred in investigating, defending and settling claims and in enforcing ***’s obligations under this Clause 13) (collectively “Liabilities” ) of any kind resulting from any claims, suits or demands made or actions brought by persons other than *** Indemnified Parties: (i) resulting from the use, administration or Commercialisation of BDP by GW, its Affiliates or Partners or its or their distributors, including without limitation any claims, suits or demands made or actions brought for bodily injury or death resulting from the use of BDP, except for any Liability for which *** has an obligation to indemnity GW under Clause 13.6, or (ii) arising from the entry or presence of the employees or representatives of GW or its Partners on ***’s premises.

13.8 Upon receipt by either GW Indemnified Parties or *** indemnified Parties (an “Indemnified Party” ) of notice of any action, suit, proceeding, claim, demand or assessment against such Indemnified Party which might give rise to any Liability, the Indemnified Party shall give prompt written notice thereof to the Party from which indemnification is sought (the “Indemnifying Party” ) indicating the nature of claim and the basis therefor, provided that the failure to give such prompt notice shall not relieve the Indemnifying Party of its obligations hereunder except to the extent the Indemnifying Party or the defence of any such claim is materially prejudiced thereby. The Indemnifying Party shall have the right, at its option, to

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

assume the defence of, at its own expense and by its own counsel, any such claim involving the asserted liability of the Indemnified Party. If any Indemnifying Party shall undertake to compromise or defend any such asserted liability, it shall promptly notify the Indemnified Party of its intention to do so, and the Indemnified Party shall agree to cooperate fully with the Indemnifying Party and its counsel in the compromise of, or defence against, any such asserted liability; provided, however, that the Indemnifying Party shall not, as part of any settlement or other compromise, admit to liability or agree to an injunction without the written consent of the Indemnified Party. Notwithstanding an election by the Indemnifying Party to assume the defence of any claim as set forth above, such Indemnified Party shall have the right (at its own expense if the Indemnifying Party has elected to assume such defence) to employ separate counsel and to participate in the defence of any claim. In the event that the Indemnified Party has a reasonable basis to believe that the Indemnifying Party may not have sufficient funds to satisfy such indemnification obligation and the Indemnifying Party upon request by the Indemnified Party cannot provide assurances of its ability to satisfy such obligation to the reasonable satisfaction of the Indemnified Party, the Indemnified Party may deduct, defer or otherwise offset from any payment obligations under this Agreement (if any) amounts reasonably necessary to satisfy such indemnification obligation.

14. INSURANCE

14.1 *** shall in respect of its activities envisaged in this Agreement maintain during any period in which *** is Producing BRM for GW and for a period of twelve (12) months thereafter: (a) commercial general liability insurance with a combined single limit for bodily injury and property damage of not less than £5 million per occurrence, (b) products liability coverage with an indemnity limit of £5 million per event or series of events to an aggregate indemnity limit in any calendar year of £10 million, and (c) an all-risks insurance policy covering the replacement cost of lie Facilities from time to time and. shall upon request provide GW with a copy of its policies of insurance it in that regard, along with any amendments and revisions thereto.

15. TERM AND TERMINATION

15.1 Unless terminated earlier in accordance with Clauses 15.2 or 15.3, this Agreement shall come into force on the Effective Date and shall continue thereafter for a fixed period of five (5) years (the “Initial Term” ). On or about the third (3 rd ) anniversary of the Effective Date the Parties shall meet to discuss whether GW wishes *** to continue supplying BRM to GW from the Facility after the expiry of this Initial Term. This Agreement may be renewed for a period of five (5) years after the expiry of the Initial Term ( “Renewal Term” ) by GW serving a notice offering such a renewal upon *** not later than twenty three (23) months prior to the expiry of the Initial

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Term and *** serving on GW a counter-notice accepting such renewal not later than twenty two (22) months prior to the expiry of the Initial Term. The procedure set out above may be repeated thereafter to renew the Agreement for additional Renewal Terms. For clarity, the Initial Term and the Renewal Term(s) together being the “Term” .

15.2 *** may terminate the Agreement forthwith by notice in writing to GW upon the occurrence of any of the following events:-

15.2.1 if GW commits a material breach of the Agreement which (in the case of a breach capable of remedy) is not remedied within thirty (30) days of the receipt by GW of notice identifying the breach and requiring its remedy;

15.2.2 if GW suffers an Insolvency Event; or

15.2.3 the provisions of Clause 10.11 notwithstanding, if GW should either: (i) fail to make payment to *** of payments which (a) have fallen due under Clause 10, and (b) are not disputed by GW, by their due date for payment in three (3) consecutive months, or (ii) fail to make payment to *** hereunder of payments which (a) have fallen due under Clause 10, and (b) are not disputed by GW, by their due date for payment on four (4) separate occasions in any twelve (12) month period.

15.3 This Agreement may be terminated by GW:

15.3.1 upon written notice to ***, with immediate effect, in the event that *** suffers an Insolvency Event;

15.3.2 upon written notice to ***, with immediate effect, in the event that ***’s Home Office Licence to Produce, Supply and Possess Cannabis is suspended, revoked, cancelled or expires without renewal or replacement;

15.3.3 upon written notice to ***, with immediate effect in the event of the supply interruption referred to in Clause 5.2 continuing for longer than sixty (60) days (other than in the case of supply interruption caused by GW or by Force Majeure);

15.3.4 forthwith by notice in writing to *** if *** otherwise commits a material breach of the Agreement which (in the case of a breach capable of remedy) is not remedied within thirty (30) days of the receipt by *** of a notice identifying the breach and requiring its remedy;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

15.3.5 upon written notice to ***, with immediate effect in the event of a Change of Control of *** where *** is acquired by a pharmaceutical company or biotechnology company which is developing or Commercialising a product which is derived in whole or in part from cannabis; or

15.3.6 in the event BDP is withdrawn or recalled due to a Marketing Authorisation for BDP being withdrawn, suspended or revoked.

15.4 The licence granted to GW under Clause 11.3 of this Agreement shall continue notwithstanding any expiry or termination of this Agreement and shall be without limit of period, save that *** may terminate the licence granted by it to GW immediately by notice in writing to the Defaulting Party if:

15.4.1 GW uses or permits any third party to use *** Technology outside the scope of such licence without ***’s prior written consent; or

15.4.2 GW or any of its Affiliates commits any breach of Clause 12 in relation to Confidential Information for which *** is the Disclosing Party; or

15.4.3 GW suffers an Insolvency Event; or

15.4.4 GW challenges or disputes the validity or ***’s ownership of any of the *** Technology.

On termination of the licence granted to GW under this Agreement in accordance with this Clause 15.4, GW shall immediately destroy or, at the request of ***, return all Confidential Information belonging to *** then in its possession, custody or control relating to such licences and shall not retain any copies of the same.

15.5 Upon the expiration or termination of the Agreement for whatever reason:

15.5.1 *** shall cease using and promptly return to GW all GW Know How and shall deliver to GW all GW Improvements not previously disclosed to GW;

15.5.2 *** shall, at GW’s direction, either return to GW all Plants and Cuttings in its possession or destroy such Plants and Cuttings;

15.5.3 *** shall organise an orderly wind down and closure of the Facility relating to the Production of BRM in a timely fashion; and

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15.5.4 *** will promptly send a close-out report to GW stating the amounts of BRM in its possession and, upon payment therefor, shall deliver to GW all such amounts of BRM to GW as specified in Clause 5.4.

15.6 In the event that GW terminates this Agreement pursuant to Clause 15.3.1, GW shall have first right to acquire all or any of the Facility, equipment, materials and other assets and Consumables of *** used in the production of the BRM and *** shall use its reasonable endeavours to procure the effectiveness of this provision and otherwise to enable that supply of the BRM to GW is maintained or restored with minimum disruption.

15.7 In the event that this Agreement is terminated by *** pursuant to Clause 15.2.1 or Clause 15.2.3 above or by GW pursuant to Clauses 15.3.5 or 15.3.6 then (in any such case) *** shall organise an orderly wind down and closure of the Facility in a timely fashion, and GW shall compensate *** in the following manner:

15.7.1 to the extent that there exists on the termination date unrecovered Dedicated Capital Expenditure, those unrecovered costs shall become payable by GW to *** upon GW receiving an invoice therefor supported by documentary evidence satisfactory to GW (acting reasonably) of the existence of such unrecovered Dedicated Capital Expenditure; and

15.7.2 GW shall pay to *** all its direct costs incurred in winding down and closure of the Facility in accordance with the strategy agreed between the Parties (acting reasonably) in relation thereto, including staff redundancy and associated costs;

Such costs shall (in either case) be invoiced by *** and shall be paid by GW in accordance with the provisions of Clause 10.7.

15.8 Termination of the Agreement for whatever reason shall not affect the accrued rights or remedies of either *** or GW arising under or out of this Agreement and all provisions which are expressed to survive the Agreement shall remain in full force and effect. In particular the provisions of Clauses 1, 11, 12, 13, 13, 15 and 17.7 shall survive termination.

16. RIGHTS SHORT OF TERMINATION

16.1 GW may at any time during the term of this Agreement on giving *** fourteen (14) weeks written notice require *** to suspend Production of BRM for any reason, such reason to be specified in the notice. The date on which such suspension becomes effective shall be the “Suspension Date” and the period from the date on which such notice is served on *** until the

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Suspension Date being the “Wind-Down Period” . “Suspension Year” shall be the period of twelve months from the Suspension Date or an anniversary of Suspension Date until the next anniversary of the Suspension Date. The “First Suspension Year” shall be the Suspension Year running from the Suspension Date until the first anniversary of the Suspension Date.

16.2 Upon receipt of a notice pursuant to Clause 16.1, *** and GW shall meet as soon as practicably possible and in any event within ten (10) Business Days thereof to discuss and agree:

16.2.1 the strategy for (i) the orderly wind-down of the Facility by the Suspension Date; and (ii) the maintenance of the Facility in a state from which BRM Production may be re-initiated in a reasonable period of time bearing in mind the reason for the suspension, and thereafter *** shall implement such strategy in a timely fashion including so that BRM Production has ceased by the Suspension Date. As part of this discussion the Parties shall discuss and agree the period of notice *** will require in order to reinitiate BRM Production at the Facility; and

16.2.2 the Costs to be incurred by *** in maintaining the Facility in accordance with the provisions of Clause 16.2.1 during the First Suspension Year and for which GW will be liable (the “Suspension Costs” ). The Parties have agreed that during the First Suspension Year GW shall pay *** the following Costs for the following periods of time as part of the Suspension Costs:

(a) the Direct Fixed Costs, which costs GW will pay to *** for a period of twelve (12) months from the Suspension Date;

(b) the Indirect Fixed Costs, which costs GW will pay to *** for shorter of: (i) six (6) months from the Suspension Date, or (ii) the period from the Suspension Date until the end of the *** financial year in which the Suspension Date occurs;

(c) the Wages and Salaries, which costs GW will pay to *** for four (4) months after the Suspension Date or such longer period as the Parties may agree pursuant to the remaining provisions of this Clause 16.2.2; and

(d) the Direct Growing Costs and. Indirect Operating Costs, which costs GW will pay to *** during the Wind-Down Period,

which Costs will be assessed by reference by to the relevant Budget(s) for Costs. When discussing which additional Costs shall form part of Suspension Costs during the First Suspension Year (if any) the Parties shall consider the reason for the suspension and the

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likelihood of GW requiring the re-initiation of BRM Production within the First Suspension Year and both Parties will use their reasonable efforts to build consensus on such matter. If the Parties cannot reach agreement on which operational and management costs shall form part of Suspension Costs during the First Suspension Year the issue shall be referred to the managing director of GW or equivalent position or his or her nominee and the managing director of *** or equivalent position or his or her nominee for resolution, who together shall use reasonable and good faith efforts to resolve such matters within thirty (30) days of the date such matters are referred to them for resolution. If the Parties still fail to resolve the matter so referred then the final decision shall be GW’s, which shall be exercised in good faith.

16.3 Notwithstanding the foregoing, the Parties shall meet regularly and not less than once every two (2) months during the First Suspension Year and any subsequent Suspension Year until expiry of the Term pursuant to Clause 15.1. In addition, the Parties shall hold a meeting on or before the last Business Day of the ninth (9 th ) month of a Suspension Year at which the Parties shall discuss whether to continue the suspension during the upcoming Suspension Year (the “Next Suspension Year” ). If either Party decides it does not wish to continue the suspension for the Next Suspension Year that Party shall state that desire at the meeting and must confirm its desire to terminate the Agreement with effect from the end of the Suspension Year in which such meeting is held by giving the other Party notice in writing within ten (10) Business Days of such meeting. If no such notice is given the Agreement shall continue. If the suspension is to continue for a Next Suspension Year, the Parties shall also discuss and agree at that meeting what changes should be made to the suspension arrangements for the Next Suspension Year, including the Suspension Costs for which GW will be liable for in the Next Suspension Year and the provisions of the third, fourth and fifth sentences of Clause 16.2.2 shall apply to such discussions.

16.4 *** shall, during any Suspension Year, invoice GW for the relevant Suspension Costs in accordance with the provisions of Clause 10.2.

17. MISCELLANEOUS

17.1 Each Party undertakes that during the term and for a period of one (1) year thereafter it shall not and shall procure that none of its Affiliates shall either on its own behalf or on behalf of any person, firm or company specifically solicit or endeavour to entice away from the other Party or any of its Affiliates those employees of the other Party or any of its Affiliates who have been directly and actively involved in directing the performance of such Party’s obligations under this Agreement without the express permission of the Managing Director of the other Party. However, the foregoing shall not be construed as limiting or restricting either Party or its

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Affiliates from hiring any employees of the other Party or its Affiliates who respond to a general solicitation (provided that such solicitation is not intentionally targeted at or prepared with a view to specifically attracting employees of the other Party) for employment by the Party or its Affiliates. The Parties consider that the restrictions contained in this Clause 17.1 are reasonable but if any such restrictions shall be found to be unenforceable but would be valid if any part of it were deleted or the period or area of application reduced such restriction shall apply with such modification as may be necessary to make it valid and effective.

17.2 *** shall be considered an independent contractor and neither the making of this Agreement nor the performance of any of the provisions hereof shall be construed to make *** an agent, employee or legal representative of GW, nor shall this Agreement be deemed to establish a joint venture or partnership.

17.3 *** shall not during the term of this Agreement grow cannabis plants for or supply materials relating thereto or derived therefrom to any third party or perform services or otherwise collaborate or deal with any third party which deals in products derived entirely or in part from cannabis in any form insofar as such services, collaboration or dealing concerns or relates to cannabis production.

17.4 If either Party is prevented or delayed in the performance of any of its obligations under this Agreement by Force Majeure, that Party shall forthwith serve notice in writing on the other Party specifying the nature and event of the circumstances giving rise to Force Majeure, and shall subject to service of such notice have no liability in respect of the performance of such of its obligations as are prevented by the Force Majeure events during the continuation of such events, and for such time after they cease as is necessary for that Party, using all reasonable endeavours, to recommence its affected operations in order for it to perform its obligations. In the event of a Force Majeure continuing for a period of over ninety (90) days then the unaffected Party shall be entitled to terminate this Agreement with immediate effect by notice in writing.

17.5 Save as expressly stated herein, this Agreement cannot be altered or otherwise amended except pursuant to an instrument in writing signed by each of the Parties.

17.6 Any notice, request, instruction or other document to be given hereunder by either Party to the other Party shall be in writing and delivered personally, or sent by facsimile with written confirmation, or by overnight courier or registered or certified mail, postage prepaid, return receipt requested.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

If to GW, addressed to:

G W Pharma Ltd, Porton Down Science Park, Salisbury, Wiltshire SP4 0JQ,

Attention: Company Secretary

Fax No.: 01980 619111

with a copy to:

Attention: The Directors

Fax No.: 01980 557111

If to ***, addressed to:

***

Attention: ***

Fax No.: ***

with a copy to:

Attention: ***

Fax No.: ***

or to such other address and fax number as a Party shall specify to the other Party in writing. Any such notice shall be deemed to have been served at the time of delivery (if delivered personally or by overnight courier) or upon the expiration of two Business Days after posting (if sent by post in England) or five Business Days after posting (if sent by post outside of England) or upon the expiration of 12 hours from transmission (if sent by facsimile). In proving service: (i) by personal delivery or overnight courier: it shall be sufficient to show that delivery by hand or courier was made; (ii) by post: it shall be sufficient to show the envelope containing the communication was properly sent by registered or certified mail with return receipt requested; or (iii) by facsimile transmission: it shall be sufficient to show that the facsimile was despatched and a confirmatory transmission report received.

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17.7 This Agreement shall be construed and the rights of the Parties hereto shall be determined in accordance with the laws of England and the Parties irrevocably submit to the jurisdiction of the English Courts. Excepting only actions and claims relating to actions commenced by third parties against either or both of the Parties any dispute, controversy and claim arising out of or relating to this Agreement (hereinafter referred to as the “Dispute” ) shall be settled as follows:

17.7.1 Either Party wishing to resolve a Dispute shall first seek to resolve the Dispute by initiating negotiation with a formal notice of dispute to the other Party identifying this Clause 16.7. The negotiation shall take place promptly following such notice and shall be between representatives of the Parties who have sufficient authority to bind the respective Parties and who are either at least one level above the highest ranking individual involved in the Dispute or is Chief Executive of that Party.

17.7.2 Having done so and having reasonably concluded that such negotiation is at an impasse or futile, then either Party may commence legal proceedings before the English Courts.

17.8 This Agreement and any agreement or document referred to herein (including the Technical Agreement and Growing Protocol) contain the entire agreement between the Parties with respect to the transactions contemplated hereby and supersedes all oral negotiations, commitments, understandings and agreements executed and delivered prior to the date hereof with respect to the transactions contemplated hereby. In the event of a conflict between the terms of this Agreement and the terms of the Growing Protocol the terms of the Growing Protocol shall prevail with respect to matters relating to cultivation of Plants. In the event of a conflict between the terms of this Agreement and the Growing Protocol with respect to any other the matter the terms of this Agreement shall prevail. In the event of a conflict between the terms of this Agreement and the terms of the Technical Agreement the terms of the Technical Agreement shall prevail with respect to matters relating to quality, Production methods and GAP. In the event of a conflict between the terms of this Agreement and the Technical Agreement with respect to any other matters the terms of this Agreement shall prevail.

17.9 Any waiver of any term or condition of this Agreement must be explicitly in writing. A waiver of any breach or failure to enforce any of the terms or conditions of this Agreement shall not in any way affect, limit or waive a Party’s rights at any time to enforce strict compliance thereafter with every term or condition of this Agreement.

17.10 This Agreement may be executed in any number of counterparts, each of which shall be deemed an original and all of which taken together shall be deemed to constitute one and the same

instrument. An executed signature page of this Agreement delivered by facsimile transmission shall be as an original executed signature page.

17.11 if and to the extent that any court of competent jurisdiction holds any provision (or any part thereof) of this Agreement (or the application thereof to any person, jurisdiction or territory) to be invalid or unenforceable, such holding shall in no way affect the validity of the remainder of this Agreement (or the application of such provision to persons, jurisdictions, territories or circumstances other than those to which it is invalid or unenforceable). In the event of such unenforceability or invalidity the Parties shall discuss in good faith and agree provisions in accordance with the Laws as near as possible in intent to that declared unenforceable or invalid.

17.12 The provisions of this Agreement are for the sole benefit of the Parties and their successors and permitted assigns, and they shall not be construed as conferring any rights in any other persons except as otherwise expressly provided in Clauses 13.6 to 13.8. The Contracts (Rights of third parties) Act 1999 shall not apply to this Agreement. Except as expressly provided in Clauses 13.6 to 13.8, no person who is not a party to this Agreement (including any employee, officer, agent, representative or subcontractor of either Party) shall have the right (whether under the Contracts (Rights of third parties) Act 1999 or otherwise) to enforce any term of this Agreement which expressly or by implication confers a benefit on that person without the express prior agreement in writing of the Parties, which agreement must refer to this Clause 17.12.

17.13 Neither Party may assign, transfer, charge or deal in any other manner with its rights or obligations under this Agreement without the prior written consent of the other Party, such consent not to be unreasonably withheld. Either Party may however sub-contract any of its rights or obligations to any of its Affiliates (for the duration that such company remains an Affiliate) without affecting that Party’s continuing liability to the other for breach of this Agreement.

IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their duly authorised representatives as of the day and year first above written.

GW PHARMA LIMITED


/s/ David Kirk
Name:	David Kirk

Title:	Finance Director
/s/ illegible

Name:	Illegible

Title:	Company Secretary


***
/s/ ***

Name:	***

Title:	***
/s/***

Name:	***

Title:	***

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SCHEDULE 1
Production Planning Procedure

Inserted hereafter

STANDARD OPERATING PROCEDURE		Supply Chain Management
		SOP No: SU-MM-013-V1
	PHOTOCOPY	SOP Title: *** Forecasting and Order Process
	Originals Stored:

Uncontrolled hardcopy unless stamped in red

GW Pharmaceuticals

SOP Number SU-MM-013-V1

SOP Title *** Forecasting

	NAME	TITLE	SIGNATURE	DATE
Author	***	***	***	***
Reviewer	***	***	***	***
Quality Assurance	***	***	***	***
Authorisation	***	***	***	***

			Effective Date	24 Oct 05

1 st Review Date		24 Oct 07		DCO Signature		Date
No changes are required.

2 nd Review Date				DCO Signature		Date
No changes are required.

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1. PURPOSE

The purpose of this Standard Operating Procedure is to detail the procedures to be used for the forecasting future demands (Growing Plan) for Botanical Raw Material (BRM) supplied by *** for use by GW.

2. INTRODUCTION

*** grows BRM for supply to GW for use in the manufacture of Cannabis Based Medicines.

In order to manage and control the Supply Chain, GW works in partnership with *** to ensure that sufficient BRM is supplied to meet the demands for products and stock holding.

The demand is forecast driven and communicated using a spreadsheet showing the forecasted requirements for BRM.

The process of reviewing the demands for GW products and making decisions about future requirements of BRM from *** is made during the monthly Operations Planning Cycle (SU-MM-012).

This SOP will not document the specifics from the Commercial Agreement or Technical Agreement that GW has in place with ***.

3. SCOPE

The scope of this SOP is for all BRM grown by *** for GW.

4. RESPONSIBILITIES

4.1 GW Supply Chain Manager

· To adhere to this SOP

· To ensure that *** are informed of potential issues to that might affect the current Growing Plan.

· To work in partnership within the Supply Chain so that both companies mutually benefit from this relationship

· To ensure that the Commercial and Technical Agreements are adhered to and should any issues arise, notify the relevant people within GW.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

· To relay the Growing Plan for *** using a spreadsheet that is emailed to the *** Project Manager.

4.2 GW Glass House Manager

· To adhere to this SOP

· To ensure that *** are informed of potential issues to that might affect the current Growing Plan

· To work in partnership within the Supply Chain so that both companies mutually benefit from the relationship

· To provide technical input to the Supply Chain Manager to aide decisions on the Growing Plan

· To act as deputy for the process of relaying the Growing Plan for *** using a spreadsheet that is emailed to the *** Project Manager

4.3 *** Project Manager

· To ensure that GW are informed of potential issues that might impact the adherence to the Growing Plan

· To work in partnership within the Supply Chain so that both companies mutually benefit from the relationship

· To ensure that the Commercial and Technical Agreements are adhered to and should any issues arise, notify the relevant people within ***

· To provide operational input to the Supply Chain Manager to aide decisions on the Growing Plan

4.4 GW Finance Deparment

· To adhere to this SOP

To ensure that the Commercial Agreement is adhered to and should any issues arise, notify the relevant people within GW

5. DEFINITIONS

Not applicable

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6. HEALTH AND SAFETY

Not applicable

7. EQUIPMENT/MATERIAL

Not applicable

8. PROCEDURE

An output of the Operations Planning Process (SU-MM-012) is a summary of the total BRM requirements for GW for the next 12-18 months. The GW growing facility and also the *** facility supplies this BRM.

As part of the Operations Planning Process, the Supply Chain Manager will discuss the Growing Plan with the GW Glass House Manager and *** Project Manager. This discussion can be by phone or face-to-face depending on the situation.

This requirement, the Growing Plan, is communicated and confirmed to the *** Project Manager each month. There is always a Growing Plan in place; therefore the monthly review is about managing changes (if required) to this Plan.

The Growing Plan is summarized in a spreadsheet and contains the following information:

· Weekly time buckets for a least the next 12 months

· Requirement for both THC and CBD

· Indication of number of benches that are required to be harvested each week for both THC and CBD

· Calculation of expected yield/m 2 per week taking into account current agreed yield and seasonal factor

· Indication of different phases (time fences) of growing BRM to highlight where changes to Growing Plan can be implemented and the resulting changes reflected in harvesting

The GW Glass House Manager and *** Project Manager will provide operational input on an ongoing basis to the assumptions made in the spreadsheet

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Changes to the Growing Plan, typically ratio of THC and CBD being grown, will be discussed and agreed before being confirmed in the Growing Plan to ensure that all parties are happy with assumptions made in terms of timing and any other factors that may need to be taken into account.

9. FORMS TO BE USED

Form Number		Form Title
None

10. INTERNAL AND EXTERNAL REFERENCES

10.1 Internal References

SU-MM-012 Operations Planning

10.2 External References

None

11. APPENDICES

None

12. CHANGE HISTORY

SOP no.		Effective Date		Significant Changes		Previous SOP no.
SU-MM-013-V1		See Page 1		First issue

SCHEDULE 2

Budget for Costs 2007

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

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***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

SCHEDULE 3

Expert Determination

1. Any matter or dispute to be determined by an expert under this Agreement ( “Expert” ) shall be referred to a person suitably qualified to determine that particular matter or dispute who shall be nominated jointly by the Parties or, failing agreement between the Parties within twenty (20) Business Days of a written request by either Party to the other seeking to initiate the Expert’s decision procedure, either party may request the President for the time being of the Association of the British Pharmaceutical Industry or any successor body to it to nominate the Expert.

2. The Parties shall with fourteen (14) days of the appointment of the Expert meet with him/her in order to agree a program for oral written and oral submissions.

3. In all cases the terms of appointment of the Expert by whomsoever appointed shall include:

3.1 a commitment by the Parties to share equally the Expert’s fee;

3.2 a requirement on the Expert to act fairly as between the Parties and according to the principles of natural justice;

3.3 a requirement on the Expert to hold professional indemnity insurance both then and for three years following the date of his/her determination;

3.4 a commitment by the Parties to supply to the expert the submissions the subject of paragraph 2 and all such assistance, documents and information as he/she may require for the purpose of his or her determination.

3.5 a commitment by the Parties that all negotiations connected with the dispute shall be conducted in confidence and without prejudice to the rights of the Parties in any future proceedings.

4. The Expert shall give a written decision which shall contain a factual analysis, his/her conclusions and the reasons for his conclusions.

5. The Expert’s decision shall be final and binding on the Parties (save in the case of negligence or manifest error).

6. The Parties expressly acknowledge and agree that they do not intend the reference to the Expert to constitute an arbitration within the scope of any arbitration legislation, the Expert’s decision is not a quasi judicial procedure and the Parties shall have no right of appeal against the Expert’s decision provided always that this shall not be construed as waiving any rights the Parties might have against the Expert for breaching his/her terms of appointment or otherwise being negligent.

SCHEDULE 4

Agreed Categories of Suspension Costs

Part A — Direct Fixed Costs

Standing charge
Forklift truck hire
Portakabin hire
Area Charge

Part B — Direct Growing Costs

Acid
Fertilizers
Biological control
Chemicals
Pots
Peat
Packaging
Sundry materials
Pest control
Soil analysis/microbiology
Waste disposal
Protective clothing
Crop consultancy
Heating
Electricity
Climate change levy
Water

Part C — Indirect Fixed Costs

Employers liability insurance
Property & liability insurance

Depreciation
Site overheads
***
***

Part D — Indirect Operating Costs

Health care
Engineering materials
Sub-contractor costs
Stationery
Postage and courier expenses
BT telephones
Mobiles
Mileage claims/fuel cards
Traveling
Subsistence
Third party entertaining
Training
Canteen general
Sanitary equipment
Staff welfare general
Physiotherapy
Cleaning contracts
Cleaning materials
Glasshouse cleaning
Sewage
Sundry
Security

Part E — Wages and Salaries

Nursery operations salaries
Nursery operations pension

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Management salaries
Management pension

Exhibit 10.25

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

Dated

6th July 2009

***

- to -

G W PHARMA LIMITED

LEASE

- relating to -

***
***
***

Ref: FWS/5463-35

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Thomson	3 Lonsdale Gardens
Snell &	Tunbridge Wells
Passmore	Kent
	TN1 1NX

Particulars

H M Land Registry

	Title Number		:

	Administrative Area		:

1.	Date		:	6 th July 2009

2.	Parties:

	A.	Landlord	:	*******

	B.	Tenant	:	G W PHARMA LIMITED (Company Registration Number 3704998) whose registered office is at Porton Down Science Park Salisbury Wiltshire SP4 OJP

3.	Short Description of Premises		:	Premises on the Ground Floor of the Building (shown edged red on the plan annexed hereto and as more particularly described in the First Schedule hereto)

4.	Term		:	A term of 4 years commencing on 6 th July 2009 and expiring on 6 th July 2013

5.	Rent		:	*** per annum being apportioned as hereinafter set out

7.	Rent Commencement Date		:	The date hereof.

8.	Permitted Use		:	The operation of the CO2 Plant with ancillary office use

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission

THIS LEASE made Between the Parties named in the Particulars

Witnesses as follows:

1.	DEFINITIONS

	The terms defined in this clause and in the Particulars shall for the purposes of this Lease (unless the context otherwise requires) have the following meanings and terms used but not defined in this clause shall have the meanings ascribed to them in clause 3 of Schedule 3

	Definition	Meaning

1.1	“Additional Service Charges”	shall mean amounts payable by the Tenant for the Analysis Service as provided in Schedule 3

1.2	“Asset Sale and Purchase Agreement”	the Asset Sale and Purchase Agreement between the Landlord the Tenant dated a copy of which is attached hereto as Schedule 4

1.3	“Building”	the building of which the Premises form part known as the *** together with any approach roads forecourt grounds parking areas and all boundary walls and fences

1.4	“CO2 Plant”	the carbon dioxide extraction equipment being sold by the Landlord to the Tenant pursuant to the terms of the Asset Sale and Purchase Agreement together with any spare and replacement parts brought on to the Premises by the Tenant for the sole purpose of the operation of such carbon dioxide extraction equipment

1.5	“Common Parts”	those parts of the Building which are not included in this Lease and which are not demised to any other tenant the use and benefit of which is common to the Tenant and the Landlord as hereinafter specified

1.6	“Force Majeure”	any circumstance beyond the reasonable control of the Landlord including (but not limited to) fire flood earthquake wind war civil commotion explosion adverse weather conditions failure of plant machinery failure of computers or vehicles and labour disputes

1.7	“Insured Risks”	to the extent that such insurance may ordinarily be available for the Building the risk of loss or damage by fire storm tempest explosion and such other risks (subject to such excesses exclusions and limitations as the insurers may require) as the Landlord acting properly may reasonably determine

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.8	“Interest”	interest during the period from the date on which the payment is due to the date of payment both before and after any judgment (inclusive) at the rate of 4% per annum above the base rate for the time being of Royal Bank of Scotland plc or in the event of Royal Bank of Scotland plc ceasing to publish a base rate such other rate of interest as is in the reasonable opinion of the Landlord an equivalent rate

1.9	“Landlord’s Licence”	the licence granted to the Landlord by the Home Office of the Government of the United Kingdom pursuant to the Misuse of Drugs Act 1971 and Schedule 1 to the Misuse of Drugs Regulations 2001 with the reference number ***

1.10	“this Lease”	this deed and any deed or document supplemental to this deed or in variation of this deed

1.11	“Plan”	means the Plan annexed hereto

1.12	“Planning Acts”	the Town and Country Planning Act 1990 the Planning (Listed Buildings and Conservation Areas) Act 1990 the Planning (Hazardous Substances) Act 1990 the Planning (Consequential Provisions) Act 1990 the Planning and Compensation Act 1991 and any future or amending legislation of a similar nature

1.13	“the Premises”	the property shortly described in clause 3 of the Particulars and more particularly defined in the First Schedule which shall include all additions alterations and improvements and all Landlord’s fixtures and fittings at any time in or on the Premises

1.14	“Landlord’s Registration”	the registration of the Landlord with the Environment Agency as a producer of hazardous waste under Registration Number NEB971 and any subsequent registrations which the Landlord is required or considers desirable to effect and maintain

1.15	“rent”	the Rent and the Service Charge but the term “rents” includes the rents reserved in clause 3

1.16	“Service Charge”	the sum of *** per annum payable by the Tenant for the Services

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

1.17	“Services”	the Services provided by the Landlord to the Tenant as set out in Schedule 3

1.18	“Service Media”	all pipes drains sewers gutters watercourses wires cables ducts flues aerials cisterns tanks and all other conducting media and ancillary apparatus and all heating apparatus serving the Premises

1.19	“Specified Person”	means any employee agent representative adviser and contractor of the Tenant or any other person under the Tenant’s control who the Landlord has permitted in writing to have access to the Premises and the Common Parts

1.20	“Tenant’s Licence”	any licence granted to the Tenant by the Home Office of the Government of the United Kingdom pursuant to the Misuse of Drugs Act 1971 and Schedule 1 to the Misuse of Drugs Regulations 2001

1.21	“VAT”	value added tax and any other similar tax imposed in addition or substitution

1.22	“1954 Act”	The Landlord and Tenant Act 1954

2. INTERPRETATION

2.1 Where in this Lease the context so admits:

2.1.1 “the Landlord” includes the reversioner for the time being immediately expectant on the determination of the Term

2.1.2 “the Term” means the term granted by this Lease

2.2 Any reference to statutes statutory instruments rules orders and regulations or the like include (unless otherwise stated) any future re-enactments or modifications thereof and those made in substitution or replacement of any which are repealed and also include all instruments orders plans regulations permissions and directions for the time being made issued or given thereunder or deriving validity therefrom

2.3 Words importing one gender include the other genders

2.4 Any provisions in this Lease referring to the consent or approval of the Landlord shall be construed as also requiring the consent or approval of any mortgagee of the Landlord but nothing in this Lease shall be construed as implying that any obligation is imposed upon any mortgagee not unreasonably to refuse any such consent or approval

2.5

2.5.1 All rights of entry or other rights or easements exercisable by the Landlord shall extend to include persons authorised by the Landlord and his surveyors servants contractors licensees and work people with or without plant and appliances and materials

2.5.2 All rights exercisable by the Tenant shall extend to include all persons authorised by the Tenant and their respective surveyors servants contractors licensees and work people with or without plant and appliances and materials

2.6 References to “the last year of the Term” include the last year of the Term if the Term shall determine otherwise than by effluxion of time and references to “the expiration/expiry of the Term” include such other determination of the Term

2.7 Reference to any clause sub-clause or Schedule shall mean a clause sub-clause or Schedule of this Lease

2.8 The details and descriptions appearing in the Particulars shall be included in this Lease and form part of this Lease and in the event of any discrepancy between the Particulars and any other part of this Lease such other part of this Lease shall prevail

2.9 The clause sub-clause and Schedule headings to this Lease are deemed not to form any part of this Lease and shall not affect the interpretation of this Lease in any way

3. DEMISE AND RENTS

3.1 In consideration of the rents reserved by this Lease and of the covenants on the part of the Tenant contained in this Lease the Landlord demises to the Tenant the Premises together with the rights specified in Part I of Schedule 2 except and reserved unto the Landlord the rights specified in Part II of Schedule 2 and all rights powers and privileges expressed to be conferred on or reserved to the Landlord under the provisions of this Lease to hold the Premises to the Tenant for the Term subject to all covenants restrictions and stipulations of whatever kind or nature which may affect or relate to the Premises yielding and paying to the Landlord during the Term:

3.1.1 First the Rent specified in paragraph 5 of the Particulars such rent to be paid by equal monthly payments in advance on the 6th day of each month the first of the payments made on the date of this Lease

3.1.2 Secondly the Service Charge and the Additional Service Charges at the times and in the manner provided by Schedule 3

3.2 This Lease is made with full title guarantee

4. TENANT’S COVENANTS

The Tenant covenants with the Landlord:

4.1 Rents

4.1.1 To pay the rents at the times and in manner as provided without any deduction abatement or set-off whatsoever

4.2 Repairs

To keep in good and substantial repair and condition the interior of the Premises and the Service Media in or exclusively serving the Premises (damage by the Insured Risks excepted save to the extent that payment of the insurance moneys shall be withheld by reason of any act or default of the Tenant or any undertenant or anyone at the Premises expressly or by implication with the Tenant’s authority)

4.3 Permit Entry to Inspect and Give Notice of and Effect Repairs

4.3.1 To permit the Landlord at reasonable times and on reasonable notice (except in emergency) to enter upon and examine the state of repair and condition of the Premises and the Service Media and to give or leave on the Premises or at the last known address of the Tenant notice of all defects and wants of repair for which the Tenant is responsible under this Lease

4.3.2 Within 28 days after the giving of the notice or sooner if required and immediately in case of emergency to commence and proceed diligently with the carrying out of the works referred to in the notice and to complete the works as soon as possible after the giving of the notice

4.3.3 If the Tenant makes default in the performance of the covenants relating to works of repair to permit the Landlord to enter the Premises and carry out the works and the cost of the works and all expenses incurred by the Landlord (including without limitation legal costs and surveyor’s fees) shall be paid by the Tenant on demand and in default be forthwith recoverable as a debt due from the Tenant together with Interest from the date of completion of the work to the date of payment by the Tenant

4.4 Permit Entry for Repair of Adjoining Premises

To permit the Landlord at reasonable times and on reasonable notice (except in emergency) to enter upon the Premises to execute repairs or alterations to any part of the Building the Landlord making good all damage caused to the Premises

4.5 Costs of Landlord

To pay to the Landlord on an indemnity basis all expenses fees charges costs expenses and disbursements incurred by the Landlord including but not limited to those payable to solicitors counsel architects surveyors and bailiffs out of or in connection with or incidental to:

4.5.1 any steps taken in contemplation of or in connection with the preparation and service of a notice under the Law of Property Act 1925 Section 146 or proceedings under Sections 146 or 147 of that Act (notwithstanding in any such case that forfeiture is avoided otherwise than by relief granted by the Court) and in connection with every application for any consent made under this Lease whether or not consent is granted

4.5.2 the service of all notices and schedules relating to wants of repair of the Premises and their use whether served during or after the expiration of the Term

4.5.3 the collection and recovery of the rents and other money payable under this Lease which shall be in arrear (including without limitation the costs of any collection agency) or any action reasonably taken by or on behalf of the Landlord in order to prevent or procure the remedying of any breach of any covenant by the Tenant

4.6 Prohibitions Relating to User

4.6.1 Not to do or permit or suffer to be done anything in or upon the Premises or any part which may be or become a nuisance or annoyance or cause damage to the Landlord or the owners or occupiers of the other property in the neighbourhood or any other part of the Building

4.6.2 Not to use the Premises for a sale by auction or for any noxious dangerous offensive or noisy trade or business or for any illegal or immoral act or purpose save as part of the Permitted Use

4.6.3 Not to suspend any heavy loads from the ceilings or main structure of the Premises nor to overload the floors or structure of the Premises

4.6.4 Not to permit any oil grease poisonous or noxious substance to be discharged into any Service Media serving the Premises

4.6.5 Not to damage or obstruct any areas over which the Tenant may have rights of access

4.6.6 To ensure that there is no release at or from the Premises of anything likely to pollute or contaminate

4.6.7 To comply with all reasonable requirements of the Landlord in relation to the operation and maintenance of the CO2 Plant

4.6.8 Not to permit any person who is not a Specified Person to gain access to the Premises or the Building

4.7 Comply with Statutory Notices and Licences

4.7.1 To comply with every statute and any notice or order from a government department or local public regulatory or other authority or Court that relates to the Premises the Service Media or any substance or article on the Premises or the CO2 Plant and the Landlord’s Licence and the Tenant’s Licence

4.7.2 To produce immediately to the Landlord a copy of any notice or order that is served on the Premises or the Tenant and that relates to the matters in the preceding sub-clause

4.7.3 At the request of the Landlord to make or join with the Landlord in making any reasonable representations that the Landlord considers appropriate or otherwise contesting any proposal of a government department or local regulatory or other authority that relates to or includes the Premises and the CO2 Plant

4.7.4 The Tenant shall comply with all laws and all requirements of the Landlord relating to:

(a) the Premises and the occupation and use of the Premises by the Tenant;

(b) the use of all Service Media and machinery and equipment at or serving the Premises including but not limited to the CO2 Plant ;

(d) all materials used at kept at or disposed from the Premises.

4.7.5 Without prejudice to any obligation on the Tenant to obtain any consent or approval under this Lease the Tenant shall carry out all works that are required under any law to be carried out at the Premises insofar as it relates to the Tenant’s use or occupation of the Premises

4.7.6 As soon as the Tenant becomes aware of any defect in the Premises or the CO2 Plant it shall give the Landlord notice of it.

4.7.7 The Tenant shall indemnify the Landlord against any liability under the Defective Premises Act 1972 in relation to the Premises by reason of any failure of the Tenant to comply with any of the tenant covenants in this lease.

4.7.8 Until such time as the Landlord’s Licence is transferred from the Landlord to the Tenant or as the case may be the Tenant’s Licence is granted to comply with all terms and conditions of the Landlord’s Licence and any other requirements notified by the Landlord to the Tenant at the Tenant’s own cost

4.8 Planning etc

4.8.1 Not to apply for any planning permission in respect of the Premises or any part

4.8.2 At all times during the Term to comply in all respects with the provisions and requirements of the Planning Acts and of all consents permissions conditions and obligations (if any) granted or imposed or having effect under the Planning Acts so far as they respectively relate to or affect the Premises or any part or the CO2 Plant or any operations works acts or things already or after the date of this Lease to be carried out executed or done or omitted on the Premises or the use of the Premises for any purpose

4.8.3 Not to carry out or make any alteration or addition to the Premises or any change of use of the Premises (being an alteration or change of use which is prohibited under this Lease and for which a planning permission needs to be obtained)

4.8.4 If and when called upon so to do to produce to the Landlord or the Landlord’s surveyor all plans documents and other evidence that the Landlord may reasonably require in order to be satisfied that the provisions of this clause or any parts of this clause have been complied with in all respects

4.8.5 Not to enter into any agreement or obligation with a local planning authority as a result of which the Premises or the Building shall become subject to any restriction of user or otherwise

4.8.6 Not to object to or obstruct any planning application made by the Landlord or on the Landlord’s behalf that may affect or relate to the Premises or the Building

4.9 Advertisements and Displays

Not without the Landlord’s previous consent in writing to display any external sign or advertisement or erect any pole mast or dish on the Premises or any part of the Building

4.10 User

To use the Premises only for the Permitted Use stated in paragraph 7 of the Particulars and not to permit any person to sleep or reside there

4.11 Alterations or Additions

Not to commit any waste make any alteration in or addition to the Premises or erect any new building or new structure on the Premises or make any alteration to the elevation or appearance of the Premises or to the Service Media serving the Premises

4.12 Alienation

Not to assign charge underlet or part with or share the possession or occupation of the whole or any part of the Premises or to execute any declaration of trust with regard to the whole or any part of the Premises

4.13 Inspection by Purchasers of Reversion

At all times throughout the Term to permit any prospective purchaser of the reversion expectant on the termination of this Lease and his advisers to inspect the Premises at reasonable times and on reasonable notice (provided that such person shall bear a letter of authority signed by or on behalf of the Landlord)

4.14

4.14.1 Not to Vitiate Insurance

Not to do or omit anything that could cause any policy of insurance on or in relation to the Premises or the Building to become void or voidable or which may render an increased or extra premium payable for the said insurance and to comply with all requirements and recommendations of the insurer and any fire officer

4.14.2 To Give Notice of Damage

In the event of the Premises the Building or any part being damaged or destroyed by any of the Insured Risks to give immediate notice to the Landlord and to pay to the Landlord on demand the amount of any excess which may be deducted or deductible by the insurers on any claim made by the Landlord in relation to the Premises or the Building

4.14.3 To Pay Costs of Rebuilding if Insurance Avoided

In the event of the Premises or any part or the Building or any part being damaged or destroyed by any of the Insured Risks and the insurance money under any policy of insurance effected by the Landlord pursuant to the Landlord’s obligations in this Lease being wholly or partly irrecoverable by reason solely or in part of any act or default of the Tenant or anyone at the Premises expressly or by implication with the Tenant’s authority then and in every case forthwith (in addition to the rents reserved by this Lease) to pay to the Landlord the whole or (as the case may be) the irrecoverable proportion of the amount of the insurance money so irrecoverable with Interest

4.15 Not to Insure Against Landlord’s Risks

Not to insure in respect of any risks against which the Landlord has insured under the provisions contained in this Lease

4.16 Not to Cause or Allow Anything which could expose the Landlord to Penalties

Not to do or omit anything in or about the Premises or any premises used for the purposes of but not comprised in the Premises whereby the Landlord may become exposed to the liability to pay any penalty damages compensation costs charges or expenses

4.17 Indemnities

To be responsible for and keep the Landlord fully indemnified against liabilities in respect of all losses damages actions proceedings claims demands costs and expenses of whatsoever nature arising in any way directly or indirectly out of:

4.17.1 the repair state of repair or condition of the Premises and the CO2 Plant for which the Tenant is liable under the covenants contained in this Lease

4.17.2 any act omission or default of the Tenant the Tenant’s underlessees or respective agents servants invitees or licensees including any Specified Person

4.17.3 the user of the Premises and the CO2 Plant

4.17.4 anything after the date of this Lease attached by the Tenant to or on the Premises

4.17.5 any breach by the Tenant of any covenants on the part of the Tenant or any condition contained in this Lease including without prejudice to the generality of the foregoing the Tenant’s obligations under the Asset Sale and Purchase Agreement

4.17.6 without prejudice to the generality of the foregoing any breach by the Tenant of the terms of the Landlord’s Licence the Tenant’s Licence or of any other Licences required or otherwise subsisting for the operation of the CO2 Plant

4.18 Regulations

To comply with all reasonable regulations made by the Landlord from time to time for the management of the Building and any rights granted to the Tenant hereunder

4.19 Payment of Money Owing

If the Tenant fails to pay to the Landlord any of the rents and/or other sums becoming payable by the Tenant to the Landlord pursuant to this Lease on the date or dates upon which the same fall due for payment then in addition to any rents and/or other sums to pay to the Landlord by way of further rent Interest calculated from the date or dates upon which the payment fell due until the date or dates of actual payment

4.20 VAT

4.20.1 To pay by way of additional rent and indemnify the Landlord against any VAT that may be chargeable on the rents or any part thereof or any other payment made by the Tenant under this Lease in addition to the rent or other payment

4.20.2 Whenever the Tenant has agreed in this Lease to reimburse the Landlord for a payment made by the Landlord to reimburse the Landlord in addition for any VAT paid by the Landlord on that payment unless the VAT is recovered by the Landlord

4.21 Notification of Keyholder and Burglar Alarm Codes

To ensure that at all times the Landlord has written notice of:

4.21.1 the name address and telephone number of at least one keyholder of the Premises and of any Specified Person;

4.21.2 all security and pass codes for any burglar alarm system at the Premises.

4.22 Defective Premises

Forthwith upon becoming aware of the same to give notice in writing to the Landlord of any defect in the state of the Premises which might give rise to an obligation on the Landlord to do or refrain from doing any act or thing in order to comply with the provisions of this Lease or the duty of care imposed on the Landlord under the Defective Premises Act 1972 and at all times to display and maintain all necessary notices which the Landlord may from time to time require to be displayed at the Premises

4.23 To Yield Up

To yield up the Premises at the expiration of the Term with vacant possession and in repair and decorative order and condition in accordance with the Tenant’s covenants contained in this Lease and to remove the CO2 Plant and the Tenant’s fixtures and fittings and all service media specifically and solely related to the CO2 Plant (if requested by the Landlord) and make good immediately any damage caused by the removal

4.24 Release of Landlord

The Tenant will not unreasonably withhold or delay consent to a request made by the Landlord in accordance with Section 8 of the Landlord and Tenant (Covenants) Act 1995 for a release from the covenants on the part of the Landlord contained in this Lease to the extent (if any) that such covenants continue to bind the Landlord after assigning the reversion

5. LANDLORD’S COVENANTS

The Landlord covenants with the Tenant:

5.1 Quiet Enjoyment

That the Tenant may peaceably enjoy the Premises during the Term without any lawful interruption by the Landlord or any person or persons rightfully claiming under or in trust for the Landlord

5.2 Insurance

5.2.1 At the Landlord’s expense, to keep the Premises (unless the insurance is rendered void by an act or omission of the Tenant or anyone at the Premises expressly or by implication with the Tenant’s authority including any Specified Person) insured against loss or damage by the Insured Risks so far as such insurance may ordinarily be effected for amounts which the Landlord shall from time to time be advised as representing the cost of reinstatement of the Premises (including professional fees debris removal and site clearance and the cost of any work which might be required by or by virtue of any Act of Parliament) and four years’ loss of rent

5.2.2 To produce to the Tenant on 14 days’ notice reasonable evidence of the terms of the policy maintained by the Landlord and the receipt for the last premium payable for it

5.2.3 In the event of the Premises being destroyed or damaged by any of the Insured Risks subject to having obtained all appropriate consents under the Planning Acts or otherwise to lay out money received by the Landlord under the policy of insurance (except money received in respect of loss of rent) in rebuilding or reinstating the Premises provided that the Landlord shall not be under an obligation to rebuild or reinstate the Premises in the form which existed before the date of the destruction or damage provided that when reinstated the Premises are no less commodious for the Tenant’s purposes

6. LANDLORD’S COVENANT RELATING TO REPAIR AND SERVICE COSTS

Subject to the rents being paid by the Tenant the Landlord covenants with the Tenant as follows:

6.1 Maintain Services

To maintain in reasonable working order and repair all Service Media in under or upon the Building which serve the Premises but not those exclusively within and only serving the Premises

6.2 Provision of Services

So far as practicable to perform the following services:

6.2.1 to keep clean and reasonably well lit the Common Parts

6.2.2 to maintain at all times during normal business hours an adequate supply of hot and cold water towels and soap and other appropriate supplies in the toilet accommodation (if any) situated in the Common Parts

6.2.3 to supply maintain repair and renew as need be such fire-fighting equipment in the Common Parts as the Landlord may deem desirable or necessary or as may be required to be supplied and maintained by statute or by the fire authority for the district or by the Landlord’s insurers

6.2.4 to provide the Services

provided always that:

(a) the Landlord may at the Landlord’s absolute discretion withhold add to extend vary or make any alteration in the rendering of any of the services mentioned in this clause from time to time if the Landlord at the Landlord’s absolute discretion deems it desirable so to do for the more efficient conduct and management of the Building save for the Services

(b) the Landlord shall not be liable to the Tenant for any defect or want of repair in respect of the items for which the Landlord covenants to repair in this clause unless the Landlord has had written notice of the defect or want of repair and had sufficient opportunity for remedying the same nor shall the Landlord be liable to the Tenant in respect of any obligation that is to be construed as falling within the ambit of any of the Tenant’s covenants in this Lease

(c) the Landlord shall not be liable to the Tenant to perform or observe the covenants on the Landlord’s part in this clause where breach is due to Force Majeure

(d) the Landlord shall not be liable to the Tenant for any defect or want of repair decoration reinstatement replacement or renewal either:

(i) to the extent that the works required to remedy it are carried out at the expense of the insurers or otherwise out of moneys arising under a policy or policies of insurance effected pursuant to this Lease or

(ii) if the cost of remedying the defect or want of repair decoration reinstatement replacement or renewal would have been recoverable under a policy or policies of insurance but for the policy or policies having been vitiated or voided in whole or in part by the act or default of any person for the time being in occupation of the Building

7. PROVISOS AGREEMENTS AND DECLARATIONS

Provided always and it is expressly agreed and declared as follows:

7.1 Forfeiture

7.1.1 If the rents hereby reserved or any part thereof shall at any time be in arrear for 21 days after the same shall have become due (whether formally demanded or not) or

7.1.2 If there shall be any breach non-performance or non-observance of any of the covenants and conditions on the part of the Tenant contained in this Lease and such breach is not remedied within a reasonable period after the Tenant has been given notice thereof by the Landlord or

7.1.3 If the Tenant shall suffer any distress or other execution to be levied on the Premises or any part or any contents in the Premises or

7.1.4 If a bankruptcy order or an administration order is made in respect of the Tenant or

7.1.5 If a resolution is passed or an order is made for the winding-up of the Tenant or

7.1.6 If a receiver or administrative receiver is appointed over the whole or any part of the property assets or undertaking of the Tenant or

7.1.7 If the Tenant is struck off the Register of Companies or is dissolved or otherwise ceases to exist under the laws of the country or state of its incorporation or

7.1.8 If the Tenant is deemed unable to pay its debts within the meaning of Section 123 of the Insolvency Act 1986

7.1.9 If the Tenant is in breach of clauses 3 or 5.1 to 5.3 (inclusive) of the Asset Sale and Purchase Agreement

then and in any such case it shall be lawful for the Landlord at any time thereafter to re-enter into and upon the Premises or any part thereof in the name of the whole and to have again repossess and enjoy the Premises as in their former estate and thereupon the Term shall absolutely cease and determine but without prejudice to any rights or remedies of the Landlord in respect of any antecedent breach of any of the covenants or conditions contained in this Lease

7.2 Rent to be Suspended if Premises Damaged

If the Premises or any part are at any time during the Term damaged or destroyed by any one or more of the Insured Risks so as to be unfit for occupation or use and the policy or policies of insurance effected by the Landlord shall not have been vitiated or payment of the policy moneys refused in whole or in part in consequence of any act or default of the Tenant or anyone at the Premises expressly or by implication with the Tenant’s authority (including any Specified Person) to the extent that it is insured in accordance with the provisions of this Lease the rent or a fair proportion according to the nature and extent of the damage sustained shall be suspended until the Premises have been rendered fit for occupation and use and any dispute regarding the cesser of rent shall be referred to the award of a single arbitrator to be appointed in default of agreement upon the application of either party by the President for the time being of the Royal Institution of Chartered Surveyors in accordance with the Arbitration Act 1996

7.3 Termination on Destruction

7.3.1 If the Premises are at any time during the Term destroyed or substantially damaged by any of the Insured Risks so as to be unfit for occupation and use and the Premises have not been rebuilt or reinstated or made fit for occupation and use within nine months after the date of destruction or damage then the Landlord may serve not less than three months’ notice in writing to determine this Lease such notice to expire not earlier than one year after the date of the destruction or damage and if upon the expiration of such notice the Premises remain unfit for occupation this Lease shall absolutely determine but without prejudice to any antecedent right or claim arising under this Lease and still subsisting at the date of such notice

7.3.2 In the event of such determination (or if the rebuilding or reinstatement of the Premises shall be prevented or frustrated by any cause whatsoever) the Landlord shall not be liable to rebuild or reinstate the Premises and the insurance money received by the Landlord in respect of the Premises and the loss of rent shall belong to the Landlord absolutely

7.4 Service of Notices

A demand for payment notice or other document required or authorised to be served or given under this Lease shall be in writing and shall only be deemed to be sufficiently served:

7.4.1 in the case of service on the Tenant if posted in an envelope addressed to the Tenant by first class registered or recorded delivery post at the Premises or (if the Tenant is a company) at the Tenant’s registered office as appears in this Lease or as last notified in writing to the Landlord (the Tenant to give notification to the Landlord as soon as practicable after any change of address of the Tenant’s registered office) or as revealed as being the Tenant’s current registered office by a company search (whether or not notified to the Landlord) or (whether or not the Tenant is a company) if left upon or attached to the Premises or some part and

7.4.2 in the case of service on the Landlord if posted by first class registered or recorded delivery post in an envelope addressed to the Landlord at the Landlord’s registered office (if any) or at any other address which the Tenant may have previously been notified in writing by the Landlord as the address at which the Landlord will accept service of notices

provided that in the case of service by post service shall be deemed to have been effected 24 hours after posting (excluding any intervening Saturdays Sundays or bank or other public holiday)

7.5 Compensation

Any statutory right of the Tenant to claim compensation from the Landlord on vacating the Premises is excluded from this Lease to the extent that the law allows

7.6 Disputes

Any dispute between the Tenant and any owner or occupier of adjacent or neighbouring property (other than the Landlord) as to any right or privilege or any party or other walls or as to the amount of any contribution towards the expenses of services used in common shall be decided by the Landlord or in such manner as the Landlord shall direct and such decision shall be binding on the parties to the dispute

8. EXCLUSION OF LANDLORD AND TENANT ACT 1954 SS.24 TO 28

8.1.1 The parties confirm that:

(a) the Landlord served a notice on the Tenant as required by section 38A (3)(a) of the 1954 Act applying to the tenancy created by this lease before this Lease was entered into

(b) David Kirk who was duly authorised by the Tenant to do so made a statutory declaration dated 2 nd July 2009 in accordance with the requirements of section 38A(3)(b) of the 1954 Act; and

8.1.2 The parties agree that the provisions of sections 24 to 28 of the 1954 Act are excluded in relation to the tenancy created by this Lease

9. INVALIDITY

If at any time any one or more provisions of this Lease is or becomes invalid illegal or unenforceable in any respect under any law the validity legality and enforceability of the remaining provisions of this Lease shall not be in any way affected or impaired thereby

10. LANDLORD’S BREAK

The parties hereby agree that in the event of the Tenant being in breach of any of its obligations under the Asset Sale and Purchase Agreement and such breach has not been made good by the Tenant within 21 days of receiving notice of such breach the Landlord may on written notice to the Tenant immediately terminate this lease without prejudice to all antecedent rights and obligations

SCHEDULE 1

Description of the Premises

All those premises edged red on the plan annexed and being part of the Building including:

1. all walls situated wholly within the Premises but not external load bearing or structural walls or supports

2. the internal plaster decorative or other finishes of all external walls

3. the floors and floor finishes but not any joists or beams supporting the floors

4. the ceilings and the decorative finishes applied to the ceilings but not the beams or joists or other structural parts of the Building to which the ceilings are affixed provided always that where there are suspended ceilings the Premises include not only the whole of the suspended ceiling and their supporting grids but also the permanent ceilings above and the void between

5. the inner halves severed medially of all internal non-structural walls dividing the Premises from any adjoining part of the Building

6. the windows and window frames and the doors and door frames (including external doors) in and to the Premises and all glass in those windows and doors

SIGNED by ***	)	/s/ ***
for and on behalf of	)
*******	)
	)


SIGNED by David J. Kirk	)	/s/ David J. Kirk
for and on behalf of G W PHARMA LIMITED	)
	)
	)

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.26

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

DATED

9th October

2009

***
- and -
***

- and -

GW PHARMA LIMITED

LEASE

- OF -

***
***
***

Ref: CM1/CW/VJS/1979529.4
21552/97995

Lovells LLP, Atlantic House, Holborn Viaduct, London EC1A 2FG

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

CONTENTS

CLAUSE			PAGE NO

1.	INTERPRETATION		1

2.	DEMISE AND RENT		3

3.	TENANT’S COVENANTS		3

	3.1	PAY RENT	4
	3.2	PAY OUTGOINGS	4
	3.3	REPAIR AND DECORATE	4
	3.4	OBSERVE LEGISLATION	4
	3.5	YIELD UP	5
	3.6	ENTRY BY LANDLORD	6
	3.7	ENTRY BY ADJOINING OWNERS	6
	3.8	COSTS OF DEFAULT	6
	3.9	USER	7
	3.10	ALTERATIONS	7
	3.11	SIGNAGE	8
	3.12	AERIALS, ETC	8
	3.13	PLANNING ACTS	8
	3.14	STATUTORY NOTICES	8
	3.15	INSURER’S REQUIREMENTS	9
	3.16	TO LET BOARD	9
	3.17	PROHIBITED ALIENATION	9
	3.18	ASSIGNMENT	9
	3.19	SUBLETTING	11
	3.20	REGISTRATION OF DEALINGS	12
	3.21	ENCROACHMENTS	12
	3.22	COSTS OF APPLICATIONS	12
	3.23	OBSERVE DOCUMENTS	13
	3.24	KEYHOLDER	13
	3.25	ENVIRONMENTAL LIABILITY	13

4.	LANDLORD’S COVENANTS		15

	4.1	INSURE	15
	4.2	QUIET ENJOYMENT	16
	4.3	PROVIDE SERVICES	16
	4.4	PROVISION OF POWER WATER ETC	16

5.	PROVISOS		16

	5.1	INTEREST ON LATE PAYMENTS	17
	5.2	RE-ENTRY	17
	5.3	RENT CESSER	18
	5.4	STATUTORY COMPENSATION	19
	5.5	DATA PROTECTION ACT 1998	19
	5.6	EXCLUSION OF LIABILITY	19

6.	RENT REVIEW		19

7.	TENANT’S OPTION TO DETERMINE		21

8.	ACCIDENTAL HAPPENINGS OR INJURIES		21

9.	NOTICES		22

10.	VAT		22

11.	LANDLORD AND TENANT (COVENANTS) ACT 1995		22

12.	ADDRESS FOR RENT DEMANDS		22

13.	DELIVERY AS DEED		22

14.	RIGHTS OF THIRD PARTIES		22

15.	CAPITAL CONTRIBUTION		22

SCHEDULES

1.	Rights granted		24

2.	Rights reserved		25

3.	Documents to be observed		26

4.	Service Charge		27

5.	Index-linked review of service charge		28

6.	Covenants by the Surety		31

7.	Authorised Guarantee Agreement		33

8.	The Regulations		35

LAND REGISTRY PRESCRIBED CLAUSES

LR1 Date of lease		9 th October 2009

LR2 Title number(s)		LR2.1 Landlord’s title number(s) ***

		LR2.2 Other title numbers None

LR3 Parties to this lease		Landlord ***** and *** whose registered offices are both at *

		Tenant GW PHARMA LIMITED a company registered in England and Wales of (registered number 3704998) whose registered office is at Porton Down Science Park Salisbury Wiltshire SP4 0JQ

		Other parties None

LR4 Property		In the case of a conflict between this clause and the remainder of this lease then, for the purposes of registration, this clause shall prevail.

		The Premises as defined in clause 1.1

LR5 Prescribed statements etc		LR5.1 Not applicable

		LR5.2 Not applicable

LR6 Term for which the Property is leased		The Term as defined in clause 1.1

LR7 Premium		None

LR8 Prohibitions or restrictions on disposing of this lease		The lease contains a provision that prohibits or restricts dispositions

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

LR9 Rights of acquisition etc		LR9.1 Tenant’s contractual rights to renew this lease, to acquire the reversion or another lease of the Property, or to acquire an interest in other land None

		LR9.2 Tenant’s covenant to (or offer to) surrender this lease None

		LR9.3 Landlord’s contractual rights to acquire this lease None

LR10 Restrictive covenants given in this lease by the Landlord in respect of land other than the Property		None

LR11 Easements		LR11.1 Easements granted by this lease for the benefit of the Property The rights and matters set out in Schedule 1

		LR11.2 Easements granted or reserved by this lease over the Property for the benefit of other property The rights and matters set out in Schedule 2

LR12 Estate rentcharge burdening the Property		None

LR13 Application for standard form of restriction		None

LR14 Declaration of trust where there is more than one person comprising the Tenant		Not applicable

LOVELLS

LEASE

THIS LEASE is made on the date set out in clause LR1

BETWEEN:

(1) the Landlord as set out in clause LR3 ; and

(2) the Tenant as set out in clause LR3.

1. INTERPRETATION

1.1 In this Lease the following words and expressions have the meanings set opposite them:

“ Access Roads ” means the roads footpaths and accessways within the Science Park not adopted from time to time and the road connecting the Science Park to ***;

“ adjoining or neighbouring premises ” includes any part or parts of the Science Park other than the Premises;

“ associated company ” means a company in the same group of companies as the Tenant as defined by section 42 Landlord and Tenant Act 1954;

“ Authorised Guarantee Agreement ” means an agreement between the Landlord and the Tenant entered into by the Tenant as covenantor in the circumstances set out in clause 3.18 hereof and containing the provisions set out in Schedule 7 hereto;

“ Centre Common Parts ” means any entrances, passageways, Access Roads, Conducting Media, car parking, hardstanding, verges, landscaping and other parts of the Science Park available or intended to be available for use and/or enjoyment by two or more of the Landlord’s tenants of the Science Park in common (but for the avoidance of doubt including all car parking areas whether or not the subject of exclusive parking rights);

“ Conducting Media ” means tanks, pipes, cables, wires, meters, drains, sewers, gutters and other things of a similar nature for the passage of electricity, gas, water, soil and other services;

“ Environmental Audit ” means an audit of the Tenant’s Activities on the Premises to be commissioned by the Landlord from time to time but not more than once per year;

“ Gateway Tenant ” means an individual, partnership or company whose prime activity either is within the areas of Science or High Technology or is the provision of support directly related to the scientific community as would maintain an appropriate mix of tenants at the Science Park to retain its character as a science park in the opinion of the Landlord acting in the interests of good estate management;

“ High Technology ” means research, development, design, manufacturing or service activities utilising, employing or manufacturing product or processes which apply bio-technology, electronics, robotics, informatics or other such scientific disciplines as the Landlord (in conjunction with the local planning authority) determines to be representative of the field of high technology;

“ Insurance Rent ” means the rent reserved by clause 2.2 ;

“ Insured Risks ” means fire and such other risks or perils (if any) as the Landlord or any superior landlord may from time to time deem it prudent to insure and have insured the Science Park (with or without the boilers, lifts and other plant and machinery in the Science Park) against;

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

“ Landlord ” includes the person or persons for the time being entitled to the reversion immediately expectant on the Term;

“ Planning Acts ” means and includes the “planning Acts” as defined in section 117 Planning and Compulsory Purchase Act 2004 together with that Act and all other legislation from time to time imposing controls on the development or use of land;

“ Premises ” means the premises (shown edged red on the plan numbered 1 annexed hereto and shown for the purposes of locating the same within the Science Park only edged red on the plan numbered 2 annexed hereto) known as *** as well as any landlord’s fixtures and fittings from time to time in the Premises and each and every part of the Premises;

“ Regulations ” means the regulations set out in Schedule 8 hereto;

“ Rent ” means the rent reserved by this Lease at the rate from time to time payable under clause 2.1 and clause 6;

“ Science ” means dependence upon the application of scientific or technological skills or knowledge in the production of new goods or services for competitive advantage;

“ Science Park ” means ***, *** and any other land from time to time owned by the Landlord which is adjoining or neighbouring;

“ Service Charge ” means the Service Charge as defined in and calculated pursuant to Schedule 4;

“ Tenant ” includes the successors in title and assigns of the Tenant;

“ Tenant’s Works ” means the internal fit-out of the Premises comprising a lobby area and toilet facilities;

“ Term ” means a term of 10 years commencing on 23 January 2009 and expiring on 22 January 2019 together with any statutory continuation;

“ VAT ” means Value Added Tax and any other tax of a similar nature.

1.2 In this Lease unless there be something in the context inconsistent therewith:

(a) words importing the masculine gender shall include the feminine gender and vice versa and words importing the singular shall include the plural and vice versa and words importing persons and all references to persons shall include companies, corporations and firms and vice versa;

(b) if at any time two or more persons are included in the expression the “Tenant” then covenants contained in this Lease or implied by or on the part of the Tenant shall be deemed to be and shall be construed as covenants entered into by and binding on such persons jointly and severally;

(c) wherever the consent or approval of the Landlord is required it may be given subject to the Tenant obtaining any necessary further consent or approval under any headlease and nothing in this lease implies that such further consent or approval will not be unreasonably withheld;

(d) where the Tenant is placed under a restriction by this Lease it includes an obligation not to permit or allow the restriction to be infringed;

(e) references to “lease” shall include “underlease” and vice versa.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

2. DEMISE AND RENT

The Landlord DEMISES unto the Tenant ALL THOSE the Premises TOGETHER with the particular rights set out in Schedule 1 hereto so far as the Landlord has power to grant the same BUT EXCEPT AND RESERVED AND SUBJECT to the particular rights and matters set out in Schedule 2 AND SUBJECT ALSO to the matters contained or referred to in the documents brief particulars of which are set out in Schedule 3 hereto TO HOLD the Premises unto the Tenant (together with but except and reserved and subject as above) for the Term YIELDING AND PAYING to the Landlord during the Term and so in proportion for any less time than a year without any deductions therefrom whatsoever the following rents namely:

2.1 until and including 22 January 2010 the rent of a peppercorn if demanded and thereafter until and including 22 October 2010 the yearly rent of £38,000 and during the remainder of the Term the yearly rent of £76,000 per annum or such higher yearly rent as may become payable pursuant to review under clause 6 by equal quarterly payments in advance on the four usual quarter days in each year of which the first payment (being the due proportion for the period commencing on 23 January 2010 and ending on the usual quarter day thereafter) shall be paid on or before 23 January 2010;

2.2 throughout the Term sums equal to a just proportion fairly attributable to the Premises of the total amounts which the Landlord shall from time to time expend by way of premium and incidental costs (including the cost of periodic valuations and any premium payable under any headlease and the whole of any increase in any premium from time to time as a result of or arising out of the manner or the purposes in or for which the Premises are kept used and occupied) in effecting and maintaining the several insurances referred to in clause 4.1 (together with any insurance effected by the Landlord against public liability risks in respect of the Science Park) each such sum to be paid immediately following a demand the first such payment in respect of amounts already so expended by the Landlord (being the due proportion commencing on 23 January 2009 to the next renewal date or dates for such insurances) to be paid on or before the date of this Lease and in the event of any dispute as to any such sum the same shall be determined by the Landlord’s surveyor (acting as an independent expert and not as an arbitrator) whose determination shall be final and binding on the parties;

2.3 throughout the Term sums equal to the Service Charge defined at the times and in the manner specified in Schedule 4;

2.4 VAT on the rents reserved by this Lease payable at the time such rents are payable.

3. TENANT’S COVENANTS

The Tenant to the intent that the obligations hereby created shall continue throughout the whole of the Term HEREBY COVENANTS with the Landlord as follows:

3.1 Pay Rent

(a) To pay the Rent, the Insurance Rent and the Service Charge at the times and in the manner required by clause 2 without deduction or set off and to pay the Rent and the Fixed Charge (as defined in Schedule 5) by bankers standing order or similar form of bank transfer if so required by the Landlord.

(b) To pay all rents and other sums when they first fall due under this Lease whilst the Term is vested in the Tenant whether or not such rents or other sums relate to a period before the Term became vested in such Tenant.

3.2 Pay outgoings

(a) To pay and keep the Landlord fully indemnified from and against all liability for all general and other rates of whatever nature or kind and all taxes, charges, duties, levies, assessments, impositions and outgoings whatever (whether parliamentary, parochial, local or of any other description) which are now or may become rated taxed charged levied assessed or imposed upon the Premises or the owner, landlord, tenant or occupier of the Premises and whether or not required to be paid by the Tenant himself.

(b) Where not supplied directly by the relevant utility company to the Tenant to pay on demand the cost (which may for the avoidance of doubt and without limitation include reasonable provision for management by the Landlord’s own staff) incurred by the Landlord in or incidental to arranging for the supply of services pursuant to clause 4.4 consumed at the Premises (which where not separately metered shall be a due proportion determined by the Landlord of such costs payable or incurred by the Landlord in respect of the Premises together with other premises).

3.3 Repair and decorate

(Damage by the Insured Risks always excepted unless the policy or policies of insurance effected by the Landlord against them shall be rendered void or payment of the insurance moneys be refused in whole or in part by reason of or arising out of any act, omission, neglect or default by the Tenant or any subtenant or other person under the control of the Tenant or any subtenant) to keep the Premises including all means of escape therefrom in case of fire or other emergency and Conducting Media forming part of and serving the Premises in good and substantial repair and condition and maintained and in good decorative and clean condition with the glass cleaned both inside and (unless the cost of the same is being met by the Tenant as part of the Service Charge) outside at least once a month and (without prejudice to the generality of the above obligations of the Tenant) in a good and workmanlike manner and to the reasonable satisfaction of the Landlord in the year 2014 and every fifth year thereafter and also in the last three months of the Term (however and whenever it may terminate) to paint with at least two coats of good quality paint all interior parts of the Premises which have previously been or ought to be painted and grain varnish paper or otherwise suitably decorate or treat with good quality materials as circumstances may require all parts of the interior of the Premises which have previously been or ought to be so dealt with and in the case of painting in the last three months of the Term the Landlord shall have the right to insist on a particular colour scheme being used.

3.4 Observe legislation

affecting the Premises or any thing in or any activity carried on by persons resorting to or working or employed at the Premises or the use and occupation of the Premises within the time limited by law or the notice requiring the same (or if no time is so limited then within a reasonable time) to the reasonable satisfaction of the Landlord and to indemnify and keep the Landlord fully indemnified against all such requirements and all actions, proceedings, costs, claims, demands, expenses and liability whatever arising out of or in connection with non-observance or non-performance of such requirements.

(b) At its own expense to obtain from the appropriate authorities all licences consents and permissions as may be required for the carrying out by the Tenant of any operations on or for the use of any part of the Premises.

(c) Not to do anything in the Premises or cause them to be used or occupied in such a way that the Landlord or any tenant or occupier of the Science Park is disabled from complying with any Acts in respect of the whole or any part of the Science Park or may under any Acts incur or have imposed upon it or become liable to pay any penalty damages compensation costs charges of expenses.

(d) In particular but without prejudice to the generality of the foregoing to comply with all the lawful requirements from time to time of the following bodies or their successors:

(i) the Health and Safety Executive;

(ii) Environmental Agency;

(iii) Home Office;

(iv) Her Majesty’s Inspector of Pollution;

(v) Department of Health and Social Security;

(vi) ***;

(vii) Customs and Excise;

(viii) Department for Environment Food and Rural Affairs;

(ix) National Radiological Protection Board.

3.5 Yield up

Quietly to surrender and yield up the Premises to the Landlord (or as the Landlord may direct) at the end or sooner determination of the Term in a state and condition in all respects in accordance with the covenants on the part of the Tenant contained in this Lease and:

(a) unless otherwise required by the Landlord, at the Tenant’s expense to remove from the Premises any alterations or additions to the Premises made during the Term; and

(b) to hand over to the Landlord all keys relating to the Premises.

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

3.6 Entry by Landlord

(a) To permit the Landlord and others authorised by the Landlord after at least three days’ prior notice (except in an emergency when no notice need be given) to enter upon the Premises to view and inspect the Premises and ascertain how the same are being used and occupied and their state and condition and to take schedules of all landlord’s fixtures and fittings and to estimate the current value of the Premises for insurance, mortgage or other purposes and to carry out an Environmental Audit.

(b) Whenever on any such inspection anything is found which constitutes a breach, non-performance or non-observance of the covenants on the part of the Tenant contained in this Lease and of which the Landlord gives notice to the Tenant to commence to remedy and make good the same within one month of the date of such notice (or immediately in the case of any breach, non-performance or non-observance of clause 3.25 or in respect of any other matter which the Landlord reasonably deems as requiring immediate remedial action) and thereafter proceed diligently with the requisite works but if the Tenant shall fail so to do to permit the Landlord if it so desires (although the Landlord shall be under no obligation so to do) without prejudice to the Landlord’s right of re-entry or any other right or remedy of the Landlord to enter upon the Premises with contractors, workmen and others and all necessary equipment, tools and materials and to execute or complete such works and to pay to the Landlord on written demand either during or on completion of such works as the Landlord may require the costs and expenses incurred by the Landlord together with all solicitors’, surveyors’ and other professional fees and expenses incurred by the Landlord in relation to such works.

3.7 Entry by adjoining owners

To permit the Landlord and others authorised by the Landlord and the tenants, owners or occupiers from time to time of any adjoining or neighbouring premises and their respective agents and contractors to enter upon the Premises with workmen and others and all necessary equipment, tools and materials after at least three days’ prior notice (except in an emergency when no prior notice need be given) in order to carry out repairs, alterations, additions, decorations or any other works to or of any adjoining or neighbouring premises which cannot reasonably be carried out without entry on to the Premises PROVIDED ALWAYS that the persons so entering shall cause as little inconvenience as possible to the Tenant or other the occupiers of the Premises and shall with the minimum of delay make good all damage thereby caused to the Premises.

3.8 Costs of default

To pay all proper costs, charges and expenses (including solicitors’ costs and bailiffs’, architects’ and surveyors’ fees) reasonably payable by the Landlord for the purposes of and incidental to the preparation, service and enforcement (whether by proceedings or otherwise) of:

(a) any notice under section 146 or 147 Law of Property Act 1925 requiring the Tenant to remedy a breach of any of the Tenant’s obligations hereunder notwithstanding forfeiture for any such breach shall be avoided otherwise than by relief granted by the Court;

(b) any notice to repair or schedule of dilapidations accrued at or prior to the end or sooner determination of the Term whether or not served during the Term;

and in default of payment all such sums shall be recoverable as rent in arrears.

3.9 User

(a) The Premises shall be kept used and occupied only for manufacture and research within Class B1 of the Town and Country Planning (Use Classes) Order 1987 (as in force at the date of this Lease) and ancillary storage and not in any other manner or for any other purpose or for any immoral or unlawful purpose or for any sale by auction and the Tenant acknowledges that nothing in this Lease constitutes a warranty that the above use complies with or will continue to comply with the Planning Acts and the Tenant shall not be entitled to any relief or compensation whatsoever from the Landlord in that respect.

(b) Neither the Tenant nor any subtenant nor any person in occupation of the Premises shall keep any animal on or about the Premises nor conduct allow or permit to be conducted anywhere on or about the Premises any research or experiments of any kind on or involving animals of whatever kind whether live or dead.

(c) Neither the Tenant nor any subtenant nor any person in occupation of the Premises shall carry out on or from the Premises research into or involving any of the following:

(i) genetic modification within the meaning of Directive 2001/18/EC;

(ii) human embryology within the meaning of the Human Fertilisation and Embryology Act 1990 (as amended); and/or

(iii) cloning, being (for the purposes of this clause) any process, including techniques of embryo splitting, designed to create a human being (or animal) with the same nuclear genetic information as another living or deceased human being (or animal as the case may be).

(d) Neither the Tenant nor any subtenant nor any person under the control of the Tenant or any subtenant shall overload any floor of or lift in or serving the Premises or pass or leave anything of a harmful nature through or in the basins or water-closets of or any Conducting Media in or serving the Premises (whether exclusively or jointly with other premises) or do anything at the Premises which shall be or may become a nuisance (whether indictable or not) or which shall cause any damage or disturbance to the Landlord or the owners, tenants or occupiers from time to time of any adjoining or neighbouring premises.

3.10 Alterations

(a) Save and except in order to comply with any of the Tenant’s obligations hereunder there shall be no reconstruction or rebuilding or carrying out of any structural alterations, additions or other works of or to the Premises nor any cutting, maiming or injuring of the main walls, joists, beams or timbers of or to the Premises nor any erecting of any new buildings or erections thereon.

(b) Except as already mentioned any non-structural alteration, addition or other works of or to the Premises shall be carried out only after there has first been obtained the written consent of the Landlord (such consent not to be unreasonably withheld or delayed) and all necessary approvals, consents, licences, permits or permissions of any competent authority, body or person and then only strictly in accordance with their terms and conditions and with such drawings and specifications of the relevant alteration, addition or other works as

the Landlord shall require and previously have approved in writing (such approval not to be unreasonably withheld or delayed).

(c) To permit the Landlord and others authorised by the Landlord to enter upon the Premises at reasonable hours during the daytime for the purpose of seeing that all alterations, additions or other works are being or have been carried out in all respects in conformity with this clause and immediately upon being required to do so to remove any alteration, addition or other works of or to the Premises which do not so conform or in respect of which any such approvals, consents, licences, permits or permissions of the competent authority, body or person has been withdrawn or has lapsed and thereupon make good all damage caused to the Premises and restore and reinstate all affected parts of the Premises to the reasonable satisfaction of the Landlord.

3.11 Signage

No fascia, sign, name plate, bill, notice, placard, advertisement or similar device shall be affixed to or displayed in or on any part of the Premises so as to be visible from the exterior other than those indicating the name of any occupier for the time being and his business and which have (with their size and positioning) been previously approved by the Landlord in writing (such approval not to be unreasonably withheld or delayed).

3.12 Aerials, etc

No television or wireless or other form of mast or aerial nor any flagpole shall be affixed to any part of the exterior of the Premises other than those which have (with their positioning) been previously approved by the Landlord in writing (such approval not to be unreasonably withheld or delayed).

3.13 Planning Acts

(a) Without prejudice to the generality of clause 3.4 fully to observe and perform all the requirements of the Planning Acts in respect of the Premises or their use and all the requirements of any approval, consent, licence, permit or permission granted under the Planning Acts which remain lawfully enforceable and affect the Premises and to indemnify and keep the Landlord fully indemnified from and against all actions, proceedings, costs, claims, demands, expenses and liability whatsoever arising out of or in connection with any non-observance or non-performance.

(b) No application shall be made for any approval, consent, licence, permit, permission, certificate or determination under the Planning Acts in respect of the Premises without the prior written consent of the Landlord (such approval not to be unreasonably withheld or delayed).

(c) Unless the Landlord shall otherwise direct in writing to carry out to the reasonable satisfaction of the Landlord during the Term (however and whenever it may terminate) all works to the Premises which as a condition of any such approval, consent, licence, permit or permission obtained by or on behalf of the Tenant or any subtenant are required to be carried out at the Premises by a date after the Term (however and whenever it may terminate).

3.14 Statutory Notices

written request and to take all reasonable and necessary steps to comply with every such notice And if so required in writing by or on behalf of the Landlord to make or join with the Landlord and any other persons for the time being interested in the Premises or any adjoining or neighbouring premises in making such objections or representations against or in respect of any such notice as the Landlord may reasonably require.

3.15 Insurer’s requirements

(a) (Save with the prior written consent of the Landlord) nothing of a noxious, dangerous, explosive or inflammable nature shall be stored, placed or kept or remain on the Premises nor shall any other thing be done in or about the Premises which does or may invalidate or render void or voidable or cause any increased premium to be payable for any policy of insurance maintained by the Landlord in respect of the Premises or any adjoining or neighbouring premises.

(b) To repay to the Landlord upon written demand as part of the Insurance Rent an amount equal to any such increased premium as may become so payable.

(c) If the Premises or any other premises shall be destroyed or damaged as a result of any matter referred to in subclause (a) of this clause or as a result of any act, omission, neglect or default by or on the part of the Tenant or any subtenant or any person under the control of the Tenant or any subtenant as a result of which any policy of insurance maintained by the Landlord is rendered void or payment of the insurance money is refused in whole or in part to pay to the Landlord on written demand or otherwise make good to the Landlord all loss, damage and expense so incurred and to indemnify the Landlord against all actions, proceedings, costs, claims, demands and liability whatsoever resulting therefrom or arising thereout including the cost of rebuilding, reinstating, replacing and making good.

3.16 To Let board

To permit the Landlord during the period of six months immediately preceding the end or sooner determination of the Term (and at any time during the Term in the event of any proposed disposal by the Landlord of its interest in the Premises) to affix and retain on any part of the Premises (but not so as materially to interfere with any trade or business carried on at the Premises or with reasonable access of light and air to the Premises) notices and boards relating to any proposed disposal by the Landlord of its interest in the Premises or for reletting or otherwise dealing with the same and to permit all persons with written authority from the Landlord or the Landlord’s agents to inspect and view the Premises at reasonable times of the day by previous appointment.

3.17 Prohibited alienation

The Tenant shall not assign, transfer, underlet, part with or share possession or occupation, mortgage or charge any part (as opposed to the whole) of the Premises nor (without prejudice to clauses 3.18 and 3.19) part with or share possession or occupation of the whole of the Premises (which is expressly prohibited) and the Tenant shall not permit or suffer any such dealing.

3.18 Assignment

(a) Not to assign the whole of the Premises without the prior written consent of the Landlord (such consent not to be unreasonably withheld or delayed) provided that the Landlord shall be entitled:

(i) to withhold its consent in any of the circumstances set out in subclause (c);

(ii) to impose all or any of the matters set out in subclause (d) as a condition of its consent.

(b) The provisos to subclause (a) shall operate without prejudice to the right of the Landlord to withhold such consent on any other ground or grounds where such withholding of consent would be reasonable or to impose any further condition or conditions upon the grant of consent where the imposition of such condition or conditions would be reasonable.

(i) where the assignee is an associated company of the Tenant unless the assignee would otherwise be an Acceptable Assignee;

(ii) where in the reasonable opinion of the Landlord the assignee is not of sufficient financial standing to enable it to comply with the tenant’s covenants in the Lease;

(iii) where the assignee enjoys diplomatic or state immunity;

(iv) where the assignee is not resident in England and Wales;

(v) where either the assignee is not an Acceptable Assignee or the combination of the assignee and a third party guarantor who executes and delivers to the Landlord a deed of guarantee reasonably acceptable to the Landlord incorporating the provisions of Schedule 6 does not meet the criteria of an Acceptable Assignee;

(vi) where in the reasonable opinion of the Landlord the assignee is not a Gateway Tenant.

(d) The conditions referred to in subclause (a)(ii) are as follows:

(i) the execution and delivery to the Landlord prior to the assignment in question of a deed of guarantee (being an Authorised Guarantee Agreement);

(ii) the payment to the Landlord of all rents and other sums which have fallen due under the Lease prior to the date of assignment;

(iii) the giving of any requisite consent of any superior landlord or mortgagee and the fulfilment of any lawful condition of such consent;

(iv) if reasonably required by the Landlord, the execution and delivery to the Landlord prior to the assignment of a rent deposit deed in such form as the Landlord shall reasonably require together with the payment by way of cleared funds of the sum specified in the rent deposit deed;

(v) if reasonably required by the Landlord, the execution and delivery to the Landlord of a deed of guarantee entered into by one or more third party guarantors reasonably acceptable to the Landlord incorporating the provisions of Schedule 6;

(vi) the assignee shall remain an Acceptable Assignee up to the date of the assignment.

(e) For the purposes of this clause the following expressions shall have the meanings set opposite them:

“ Acceptable Assignee ” means proposed assignee:

(i) whose Audited Accounts for the three financial years which immediately precede the Application Date show pre-tax profits for each of those years which equal or exceed three times the Total Rent payable in each of those years; and

(ii) whose net realisable assets (after the deduction of all figures attributed to goodwill and other intangible assets and to stock and (in the case of a company) of any prospective liability for Corporation Tax on capital gains in the event of the assets being realised at balance sheet or any note to the balance sheet value) as shown in that assignee’s Audited Accounts for the financial year of that assignee which immediately precedes the Application Date exceed in value five times the Total Rent;

“ Application Date ” means any date on which the Tenant shall give to the Landlord notice of its intention to assign the Premises;

“ Audited Accounts ” means

(1) in the case of a limited company accounts prepared and published in accordance with the relevant requirements of the Companies Act 1985 and 1989 and of all other applicable statutes and all orders, rules and regulations (whether statutory or issued by any regulatory authority);

(2) in the case of a company not registered in Great Britain such accounts and accounting records as may be available and prepared according to the relevant requirements of the legislation and all other applicable rules of the country in which the assignee is resident;

(iii) in any case accounts prepared and published in accordance with best current accounting practice;

“ Total Rent ” means the total of the yearly rents reserved and payable under this Lease and where this Lease provides for a review of the Rent then account shall be taken of the amount of any likely increase payable from any relevant Review Date as defined in clause 6.1(a).

3.19 Subletting

(a) The Tenant may subject to the provisions of subclauses (b), (c), (d), (e) and (f) of this clause sublet the whole of the Premises or any part of the Premises Provided That the Premises shall not be split into more than two units of occupation in total at any time.

(b) The Tenant shall not sublet or agree to sublet the Premises or any permitted part of the Premises otherwise than at the open market rent then reasonably obtainable with vacant possession on the open market without fine or premium with provision for upwards only review of such rent as at each Review Date (as defined in clause 6.1(a)) which shall occur during the term of the relevant underlease in a similar manner (mutatis mutandis) as provided in clause 6 and every permitted underlease (whether mediate or immediate) of the whole or any permitted part of the Premises shall (so far as applicable) contain covenants by the subtenant in the same form as those contained in clauses 3.17, 3.18 and 3.19.

(c) Before or at the same time as any underletting of the whole of the Premises or an underletting of a permitted part of the Premises shall be effected the proposed subtenant shall enter into direct covenants with the Landlord in such form as the Landlord shall require to observe and perform all the covenants and agreements on the part of the Tenant and the stipulations and conditions contained in this Lease (other than the payment of the Rent, Insurance Rent and the Service Charge) during the term of the underlease.

(d) Any underlease shall contain a valid and effective agreement to exclude the provisions of sections 24-28 (inclusive) of the Landlord and Tenant Act 1954 in relation to such underlease.

(e) The Tenant shall not sublet the Premises or agree to sublet the Premises otherwise than to a subtenant who in the reasonable opinion of the Landlord is a Gateway Tenant.

(f) Subject and without prejudice to the other provisions of this clause there shall be no underletting of the whole of the Premises and no underletting of a permitted part of the Premises without the prior written consent of the Landlord.

3.20 Registration of dealings

Within 21 days of every assignment or transfer (whether by deed, will or otherwise) and every mortgage or charge and every permitted underletting of the Premises or any permitted part and upon every other disposition or transmission or devolution of the Premises (including all Orders of Court, Probates and Letters of Administration) notice shall be given to the Landlord’s solicitors with the date and short particulars of the dealing and the names and addresses of every party and at the same time the deed, document or instrument creating or evidencing the dealing shall be produced to the Landlord’s solicitors for registration (with a certified copy for retention by the Landlord) and such solicitors’ fee of £40 for such registration shall be paid by the Tenant.

3.21 Encroachments

(a) Neither the Tenant nor any subtenant shall effect, authorise or permit any encroachment upon or acquisition of any right, easement, quasi-right, quasi-easement or privilege adversely affecting the Premises or any closing or obstruction of the access of light or air to any windows or openings of the Premises nor shall the Tenant or any subtenant give any acknowledgement to any third party that the enjoyment of access of light or air is by the consent of such third party or give any consideration to any third party or enter into any agreement with any third party for the purpose of inducing or binding such third party to abstain from obstructing the access of light or air.

(b) If any such encroachment or acquisition or closing or obstruction shall be threatened or attempted to give notice of the dealing to the Landlord as soon as the same comes to the knowledge of the Tenant or of any subtenant and upon request by the Landlord to take immediate steps (in conjunction with the Landlord and other interested persons if the Landlord shall so require) and to adopt all such lawful means and do all such lawful things as the Landlord may reasonably deem appropriate for preventing any such encroachment or acquisition.

3.22 Costs of applications

To pay all proper costs and expenses (including surveyors’ fees and solicitors’ charges and all stamp duties and other disbursements) incurred or payable by the Landlord in respect of every application to the Landlord for any consent or approval hereunder

whether or not such consent or approval is granted or refused or the application for same is withdrawn.

3.23 Observe documents

To observe and perform the agreements, covenants and stipulations contained or referred to in the documents brief particulars of which are set out in Schedule 3 hereto in so far as the same are still subsisting and capable of being enforced against the Premises or the owner, landlord, tenant or occupier of the Premises and to keep the Landlord throughout the Term fully indemnified against all actions, proceedings, costs, claims, demands, expenses and liability in any way relating to such matters.

3.24 Keyholder

To ensure that at all times the Landlord has written notice of the name home address and home telephone number of at least two keyholders of the Premises.

3.25 Environmental Liability

(a) In this clause:

(i) “Environmental Claim” means any formal written notice given by any person or body including without limitation any relevant enforcing or regulatory authority alleging liability or potential liability including (without limitation) investigatory costs remedial costs administrative costs fines damages and penalties arising out of or based on or resulting from either regulatory civil or criminal action relating to either the presence or release migration or escape into the environment of any Hazardous Materials and forming the basis of any infringenient of any Environmental Laws;

(ii) “Environmental Laws” means all legal requirements relating to the pollution or protection of the environment (as defined in Section 1(2) of the Environmental Protection Act 1990) or harm to human health or the environment including without limitation those relating to Environmental Matters or otherwise relating to the manufacture processing distribution use treatment storage keeping disposal transport or handling of Hazardous Materials or of goods containing Hazardous Materials;

(iii) “Environmental Matters” means waste (as defined in Section 75 of the Environmental Protection Act 1990) contaminated land discharges and emissions of Hazardous Materials into any environmental medium noise and vibration heat light and radiation dangerous hazardous or toxic substances and materials nuisance (including statutory nuisance) and health and safety;

(iv) “Hazardous Materials” means all chemicals pollutants contaminants waste petroleum petroleum products pesticides dangerous or noxious or hazardous or toxic or carcinogenic or radioactive or explosive or combustible or inflammable substances and materials (in each case whether in the form of a solid liquid, gas or vapour, and whether alone or in combination) which are in each case causing or in a condition capable of causing harm or damage to the environment or to the health and safety of persons;

(v) “Pre-existing Environmental Matters” means the presence of any Hazardous Materials at the Premises or any Environmental Matters in existence at the Premises in either case prior to the first occupation of the Premises by the Tenant (except to the extent the condition of such

Hazardous Materials or Environmental Matters has been made worse by the act or negligent omission of the Tenant).

(b) Save in relation to Pre-existing Environmental Matters, not to discharge or permit or suffer to be discharged any Hazardous Materials from the Premises to any adjoining or neighbouring property and not to cause contamination or pollution at, on, in or under the Premises.

(c) As soon as is reasonably practicable to notify the Landlord in writing of the following and to supply to the Landlord such further information relating to such matters as the Landlord may reasonably (save for information which has the benefit of legal privilege) require:

(i) the presence at the Premises of any Hazardous Materials in any condition or any occurrence on the Premises that either results or could result in the breach of the terms of this Lease relating to Environmental Matters or that might form the basis of an Environmental Claim in respect of the Premises or any other property;

(ii) any pending or threatened Environmental Claim in respect of the Premises.

(d) If the Landlord acting reasonably shall believe that the terms of this Lease relating to Environmental Matters have been breached or that Hazardous Materials (other than petrol in the petrol tanks of vehicles at the Premises in accordance with the provisions of this Lease or usual waste or any Hazardous Materials used in the ordinary course of the Tenant’s business which have been notified to and approved by the Landlord, acting reasonably) have been brought on to the Premises then the Landlord may cause an independent environmental consultant chosen by the Landlord to make an inspection of the Premises (including making such tests and taking such samples as the consultant considers necessary or desirable) on such terms as the Landlord shall reasonably determine Provided that if such inspection reveals that the terms of this Lease have been so breached the Tenant shall pay to the Landlord on demand the costs and expenses of such inspection.

(e) Whenever required by the Landlord and save in relation to Pre-existing Environmental Matters, the Tenant shall at the Landlord’s option either:

(i) carry out at the Tenant’s expense such remedial works as the Landlord shall reasonably require to ensure that the Premises comply with all Environmental Laws insofar as any act default or omission of the Tenant has caused or is causing a breach of such laws; or

(ii) grant the Landlord uninterrupted access to carry out such remedial works and reimburse the Landlord on demand all costs and expenses of and associated with such remedial works.

(f) Save in relation to Pre-existing Environmental Matters, to keep the Landlord indemnified from and against all expenses, costs, claims, demands, losses, liabilities, damages, fines and penalties which the Landlord may suffer or incur as a consequence of Environmental Claims arising out of any act default or omission of the Tenant and against all expenses, costs, claims, demands, losses, liabilities, damages, fines and penalties in respect of or arising from damage to or pollution of the environment or damage to property or harm to human health caused or permitted by the Tenant at the Premises and against all expenses, costs, claims, demands, losses, liabilities, damages, fines and penalties arising from the Tenant’s breach of its covenants given in this clause 3.25.

(g) To comply with the Regulations and all such further regulations and directions as the Landlord may from time to time make and provide to the Tenant in writing.

(h) The Tenant hereby acknowledges and covenants that its obligations and all its liabilities in relation to all Environmental Claims and environmental matters during the subsistence of this Lease shall continue despite expiry or sooner determination of this Lease.

3.26 Tenant’s occupation

Between 23 January 2010 and 22 July 2010 inclusive, to inform the Landlord as soon as reasonably practicable if the Tenant should physically occupy substantially more than 50% of the net internal area of the Premises and to permit the Landlord to enter the Premises upon reasonable written notice and during usual business hours in order to inspect the degree of the Tenant’s physical occupation of the Premises. This right of entry is without prejudice to the Landlord’s other rights of entry contained in this Lease or otherwise and it is hereby acknowledged that, for the purposes of calculating the Initial Charge pursuant to and as defined in Schedule 5 of this Lease, as soon as the Tenant occupies an additional area of the Premises it shall be deemed to occupy that area for the remainder of the Term, whether or not it does in fact do so.

4. LANDLORD’S COVENANTS

The Landlord covenants with the Tenant as follows:

4.1 Insure

(a) To insure and (unless such insurance shall become void or payment of the insurance moneys shall be refused in whole or in part by reason of any act, omission, neglect or default by or on the part of the Tenant or any subtenant or other person under the control of the Tenant or any subtenant) to keep insured or to procure that any superior landlord (if applicable) shall insure and (unless as mentioned above) keep insured and to pay all premiums for insuring and keeping insured the Science Park (whether or not with other premises) against loss or damage by the Insured Risks for the full reinstatement cost together with insurance against:

(i) architects’, surveyors’ and other professional advisers’ fees at the usual scales current for the time being and the cost of demolition and site clearance consequent upon rebuilding or reinstatement; and

(ii) three years’ loss of the Rent and the Service Charge or loss of the Rent and the Service Charge for such period as the Landlord shall in its absolute discretion deem necessary for the rebuilding or reinstatement of the Science Park taking into account any likely increases in such rents during such period.

(b) (Unless as mentioned above) to apply all such moneys (except moneys received in respect of loss or damage of or to such adjoining or neighbouring premises or any fixtures and fittings liability to third parties or loss of rent) as the Landlord may receive under or by virtue of such insurance in rebuilding or reinstating the Premises or such parts as may have been damaged or destroyed as expeditiously as possible (subject always to the Landlord being able to obtain all such approvals, consents, licences, permits and permissions from any superior landlord or other competent authorities and all such materials and labour as may be necessary for such rebuilding and reinstatement).

4.2 Quiet enjoyment

That the Tenant paying the Rent, the Insurance Rent, the Service Charge and all other moneys which may become payable hereunder by the Tenant and observing and performing the several covenants and agreements on the Tenant’s part and the conditions and stipulations contained in this Lease shall and may peaceably hold and enjoy the Premises during the Term in accordance with the provisions of this Lease without any lawful interruption by the Landlord or any person lawfully claiming under or in trust for the Landlord.

4.3 Provide services

Unless prevented by strikes, lockouts, unavailability of materials or labour or by any other matter outside the control of the Landlord and so long as the Tenant shall pay the Service Charge the Landlord shall use its best endeavours to carry out the works and to provide the services referred to in Schedule 4 Part B hereto.

4.4 Provision of power water etc

(a) Until such time (if any) as the Landlord shall arrange for the provision of all or any of the following services directly from the relevant utility company the Landlord shall subject to the Tenant paying the outgoings referred to in clause 3.2(b) use all reasonable endeavours to procure the supply of the following services to the Premises:

(i) electricity;

(ii) heated water;

(iii) mains raw water;

(iv) sewerage;

(v) medium temperature hot water for heating.

(b) The Landlord may upon written notice to the Tenant of not less than five working days suspend for such reasonable period as may be necessary for repair replacement modernisation (including works to supply any service to the Premises directly from the relevant utility company) any of the services referred to in clause 4.4(a) and in any event the Landlord shall be under no liability in respect of any failure in the performance or observance of any such obligation PROVIDED THAT if such suspension exceeds 24 continuous hours, the Landlord shall provide equivalent temporary services at its own cost.

(c) In the event of any failure to pay the outgoings referred to in clause 3.2(b) or any part of them within 14 days of demand the Landlord may in its absolute discretion and without prejudice to any other remedy available to the Landlord cease to arrange for the supply to the Premises of the service or services to which the non-payment relates until such time as payment is made.

(d) All liability on the part of the Landlord pursuant to this clause shall cease in respect of any service which the Landlord shall acting reasonably and in the interests of good estate management (and without any obligation so to do) make arrangements to have supplied directly to the Premises by the relevant utility company.

5. PROVISOS

PROVIDED ALWAYS AND IT IS AGREED as follows:

5.1 Interest on late payments

(a) Whenever the whole or any part of the Rent or the Insurance Rent or the Service Charge (whether formally or legally demanded or not) or any other moneys which may become payable hereunder by the Tenant to the Landlord shall remain unpaid after becoming due and payable then the amount or the balance for the time being unpaid shall (without prejudice to the Landlord’s right of re-entry or any other right or remedy of the Landlord) as from the due date for payment and until the same is duly paid bear and carry interest thereon (as well after as before any judgment) at the rate of four per cent per annum above the base rate for the time being of Barclays Bank PLC or (in the event of such rate ceasing to be published) at such equivalent rate as the Landlord shall notify to the Tenant.

(b) In the event of there being any breach by the Tenant of the covenants on its part contained in this Lease and the Landlord having notified the Tenant in writing that by reason of such breach the Rent or Insurance Rent or the Service Charge will not be accepted for the time being then the amount or the balance for the time being outstanding shall (but without prejudice as mentioned above) as from the date of the notice served by the Landlord in respect of such breach or (if later) from the due date for payment until the date on which payment is tendered by the Tenant following the remedying of such breach bear and carry interest thereon (as well after as before any judgment) at the above rate;

and the Tenant accordingly COVENANTS with the Landlord that in every such case the Tenant will pay such interest thereon to the Landlord in addition to the Rent and Insurance Rent and Service Charge and other moneys (as well after as before any judgment) at the above rate and in default of payment such interest shall be recoverable as rent in arrears.

5.2 Re-entry

Without prejudice to any other provisions contained in this Lease, if:

(a) any of the rents reserved by this Lease are unpaid for 21 days after becoming payable (whether formally demanded or not);

(b) the Tenant is in breach of any of its obligations in this Lease;

(c) the Tenant (being a company) enters into liquidation whether compulsory or voluntary (other than for the purpose of reconstruction or amalgamation not involving a realisation of assets) or a resolution is passed or a petition is presented for such liquidation;

(d) an administrator is appointed in respect of the Tenant pursuant to the Insolvency Act 1986 or the Insolvent Partnerships Order or application is made for such administration or notice is given under paragraph 15 or 26 of Schedule B1 to the Insolvency Act 1986 (as amended);

(e) a receiver is appointed in respect of the Tenant or any assets of the Tenant;

(f) (where the Tenant comprises or includes one or more individuals) a bankruptcy order is made against any such individual or a petition is presented for such bankruptcy order;

(g) the Tenant becomes insolvent or unable to pay its debts within the meaning of section 123 Insolvency Act 1986 or makes a proposal for or enters into any

composition with its or his creditors or makes a proposal for or enters into a voluntary arrangement (within the meaning of section 1 or section 253 Insolvency Act 1986);

(h) distress, sequestration or execution is levied on the Tenant’s goods; or

(i) any event analogous to any of the above events occurs in any jurisdiction other than England and Wales

then the Landlord may at any time re-enter the Premises or any part of the Premises in the name of the whole and immediately this Lease shall terminate absolutely but without prejudice to any rights of the Landlord in respect of any breach of any of the obligations on the Tenant’s part in this Lease.

5.3 Rent cesser

If the Premises or any material part or access roads within the Science Park shall at any time or times be destroyed or damaged by any of the Insured Risks so as to render the Premises unfit for occupation and use then and in every such case (unless as provided in clause 4.1(a)) the Rent and Service Charge or a fair and just proportion according to the nature and extent of the damage sustained (as agreed between the Landlord and the Tenant in writing within one month of such destruction or damage) shall for a period of three years (or for such other period as the Landlord shall have insured under clause 4.1(a)) from the date of such damage or destruction or (if earlier) until the Premises and access roads within the Science Park have been rebuilt or reinstated and made fit for occupation and use be suspended and cease to be payable and failing such agreement or in case any dispute shall arise as to the amount of such suspension and/or such period the same shall be determined by an independent surveyor who shall:

(a) be a chartered surveyor with at least ten years experience in the assessment of rent for premises of a similar nature in the locality of the Premises;

(b) be appointed by the President or Vice President for the time being of the Royal Institution of Chartered Surveyors on the application of whichever of the Landlord and the Tenant shall first so apply;

(d) on his appointment serve written notice on the Landlord and the Tenant;

(e) consider any written representations by or on behalf of the Landlord or the Tenant concerning such matter which are received by him within 28 days of such service but otherwise have an unfettered discretion to determine such matter;

(f) serve notice of such determination on the Landlord and the Tenant as soon as he has made it;

(g) be paid his proper fee and expenses in connection with such determination by the Landlord and the Tenant in equal shares or any such shares as he may determine;

and any such determination shall be final and binding on the parties Provided that if and whenever any person so appointed shall die, be adjudged bankrupt or become of unsound mind or if both the Landlord and the Tenant shall serve upon such person written notice that in their opinion he has unreasonably delayed making such determination such person shall ipso facto be discharged and be entitled only to his reasonable expenses prior to such discharge and another such independent surveyor shall be appointed to act in his place.

5.4 Statutory compensation

The Tenant shall not be entitled on quitting the Premises to any compensation under section 37 Landlord and Tenant Act 1954 (as amended).

5.5 Data Protection Act 1998

For the purposes of the Data Protection Act 1998 or otherwise the Tenant and the Surety (if any) acknowledge that information relating to this tenancy will be held on computer and other filing systems by the Landlord or the Landlord’s managing agent (if any) for the purposes of general administration and/or enforcement of this Lease and agree to such information being used for such purposes and being disclosed to third parties so far only as is necessary in connection with the management of the Landlord’s interest in, the insurance of and/or maintenance of the Premises, checking the credit-worthiness of the Tenant and the Surety, or the disposal or sub-letting of the Premises, or is necessary to conform with recognised industry practice in the management and letting of property.

5.6 Exclusion of liability

The Landlord shall not be liable to observe or perform any obligation on its part contained in this Lease (and the Tenant releases the Landlord from all liability in respect of any breach or non-observance of any such obligation) after it has ceased to be entitled to the reversion immediately expectant upon the Term.

6. RENT REVIEW

IT IS ALSO AGREED AND DECLARED between the parties hereto as follows:

6.1 IN THIS CLAUSE:

(a) the “Review Date” means and includes 23 January 2014 and the date of expiry of each period of 5 years thereafter;

(b) the “Market Rack Rent” means the annual rack rent exclusive of all outgoings at which the Premises might reasonably be expected to be let as a whole as between a willing landlord and a willing tenant in the open market for a term of five years from the relevant Review Date without payment of any fine or premium upon the terms and subject to covenants, agreements, stipulations and conditions similar to those contained in this Lease (except as to the Term and the amount of the Rent but including similar provisions for review) but upon the assumption that:

(i) the Tenant has complied with all of the covenants on the part of the Tenant in this Lease contained;

(ii) the Premises are available to be let with vacant possession (but such assumption shall not give rise to any discount or abatement of the Market Rack Rent to allow for any discount or rent free period which a willing landlord would or might grant or allow a willing tenant upon or as a term of the grant and acceptance of such letting);

(iii) the Premises are fit and ready for immediate occupation and for any use permitted by this Lease and by any licence or consent granted by the Landlord prior to the relevant Review Date at the request of the Tenant or any permitted undertenant or any predecessor in title of them or either of them respectively;

(iv) in case the Premises have been destroyed or damaged they have been fully restored;

(v) all Value Added Tax payable by the Tenant under the provisions of this Lease is recoverable by the Tenant in full;

and disregarding (if appropriate):

(1) any effect on rent of the fact that the Tenant or any permitted undertenant or their respective predecessors in title or any other permitted occupier has been or is in occupation of the whole or any part of the Premises;

(2) any goodwill attached to the Premises by reason of the carrying on at the Premises of the business of the Tenant or any permitted undertenant or other permitted occupier;

(3) any permitted improvement to the Premises carried out by and at the expense of the Tenant or any permitted undertenant or any predecessor in title of them or either of them respectively otherwise than in pursuance of an obligation to the Landlord and being such an improvement completed after the date of this Lease but not more than 21 years before the relevant Review Date but, for the avoidance of doubt, neither the Tenant’s Works nor the Landlord’s contribution towards them referred to in clause 15 of this Lease shall be disregarded;

(4) any works of demolition, construction, alteration or addition carried out or being carried out on the Premises (otherwise than by and at the instance of the Landlord or in pursuance of an obligation to the Landlord) which diminish the rental value of the Premises at the relevant Review Date.

6.2 As at each Review Date there shall be a review of the Rent and the Landlord and the Tenant shall seek to agree the Market Rack Rent but failing written agreement between the parties the Landlord or the Tenant may at any time not more than two months prior to the relevant Review Date refer the determination of the Market Rack Rent to an independent surveyor (being such a person as is mentioned in clause 5.3(a) and who shall be appointed as mentioned in clause 5.3(b)) acting as an arbitrator (in which case the Arbitration Act 1996 shall apply) or (if the Landlord and the Tenant shall so agree) such independent surveyor shall act as an expert and not as an arbitrator.

6.3 If the determination of the Market Rack Rent shall be referred to an expert in accordance with the previous clause then clause 5.3(d), 5.3(e), 5.3(f) and 5.3(g) shall also apply and such expert shall give notice in writing of his decision within two months of his appointment or within such extended period as the parties may agree.

6.4 The Rent payable hereunder as from such Review Date (the “Reviewed Rent”) until next increased on a subsequent Review Date or the end or sooner determination of the Term (as the case may be) shall be the greater of the Rent payable hereunder immediately prior to the relevant Review Date (the “Current Rent”) and the Market Rack Rent agreed or determined in accordance with clause 6.2.

instalment would have been due during such period if the Reviewed Rent had then been ascertained such interest being chargeable at the rate of two per cent per annum above the base rate for the time being of Barclays Bank PLC or (in the event of such rate ceasing to be published) at such equivalent rate as the Landlord shall notify to the Tenant.

6.6 A Memorandum of the Market Rack Rent shall be entered into between the parties in such terms as the Landlord shall reasonably require.

7. TENANT’S OPTION TO DETERMINE

7.1 The Tenant may end this Lease on 23 January 2016 by giving at least 18 months’ written notice expiring on that day provided that at the time of expiry of such notice:

(a) there are no arrears of any of the rents reserved by clauses 2.1, 2.3 and 2.4 of this Lease; and

(b) vacant possession of the Premises is given.

7.2 If any of the conditions referred to in (a) or (b) above are not satisfied at the date of expiry of such notice the notice is deemed to be of no effect and this Lease shall continue as before, provided that the Landlord may waive all or any of such conditions by giving notice to the Tenant at any time.

7.3 The ending of this Lease shall not affect either party’s rights in respect of any earlier breach of any provision of this Lease.

7.4 On the date on which this Lease ends pursuant to this clause, the Tenant shall hand over to the Landlord the original Lease and all other title deeds and documents relating to the Premises, and shall execute such document as the Landlord shall reasonably require in order to cancel any entry or title at the Land Registry.

7.5 Nothing in this clause shall have the effect of making time of the essence for the purposes of the review of rent under this Lease.

8. ACCIDENTAL HAPPENINGS OR INJURIES

8.1 The Landlord shall not be responsible to the Tenant or the Tenant’s licensees servants agents tradesmen or other persons in the Premises or any part thereof or calling upon the Tenant or upon the Science Park for any accidental happening or injury suffered to or loss of any chattel or property (save when the same are due to the default or negligence of the Landlord) sustained on the Premises the Science Park or any part thereof and the Tenant shall indemnify the Landlord against all claims actions and proceedings in respect of any such accident happening or injury.

8.3 The Landlord shall not be liable to the Tenant or any other person claiming through the Tenant for any loss or damage whatsoever howsoever caused and whether such may have been caused directly or indirectly by the use or occupation of any other part of the Science Park by any other occupier or not.

9. NOTICES

This Lease shall incorporate the provisions as to notices contained in section 196 Law of Property Act 1925 as amended by the Recorded Delivery Service Act 1962 and every notice required to be given hereunder shall be in writing.

10. VAT

10.1 All rents and other sums payable by the Tenant hereunder which are for the time being subject to VAT shall be considered to be tax exclusive sums and the VAT at the appropriate rate for the time being shall be payable by the Tenant in addition.

10.2 The Tenant shall indemnify and keep indemnified the Landlord against any VAT paid or payable by the Landlord in respect of any costs, fees, disbursements, expenses or other sums which the Landlord is entitled to recover under the terms of this Lease.

11. LANDLORD AND TENANT (COVENANTS) ACT 1995

This Lease is a new tenancy within the meaning of section 1 Landlord and Tenant (Covenants) Act 1995.

12. ADDRESS FOR RENT DEMANDS

Whilst GW Pharma Limited is the Tenant all rent demands should be sent to “c/o GW Pharmaceuticals Plc, Building 114, Porton Down Science Park, Porton, Wiltshire SP4 OJQ” unless it notifies the Landlord of another address.

13. DELIVERY AS DEED

This document shall be treated as having been executed as a deed only upon being dated.

14. RIGHTS OF THIRD PARTIES

No person other than a contracting party may enforce any provision of this Lease by virtue of the Contracts (Rights of Third Parties) Act 1999.

15. CAPITAL CONTRIBUTION

15.1 As soon as reasonably practicable following completion of a licence for alterations authorising the Tenant’s Works, the Tenant shall commence the Tenant’s Works in accordance with the provisions of such licence and shall ensure that they are completed to the satisfaction of the Landlord, acting reasonably.

15.2 Subject to clauses 15.4 and 15.5 below, the Landlord shall pay the sum of £20,000 (exclusive of VAT) (the “Capital Contribution”) towards the costs of the Tenant’s Works by CHAPS transmission to the account of the Tenant or as the Tenant may direct two working days after delivery of the VAT invoice referred to in clause 15.3 below and after verification under clause 15.5 below.

15.3 The above payment shall be made together with VAT at the rate applicable at the time of payment, and the Tenant shall issue and deliver to the Landlord a valid VAT invoice for such sum prior to payment which will contain details of the works in respect of which the contribution is made.

15.4 Without prejudice to the provisions of the licence for alterations referred to above, should the Tenant’s Works not have been completed to the Landlord’s satisfaction, acting reasonably, by 22 January 2019, the Landlord may require the Tenant to repay the Capital Contribution along with interest at the rate of 2% per annum above the base rate of Barclays Bank PLC or (in the event of such rate ceasing to be published) at such equivalent rate as the Landlord shall notify to the Tenant, to the Landlord by CHAPS transmission to such account as the Landlord may direct within two working days of the Landlord’s demand which may be made at any time until 22 July 2019.

REGISTRATION FOR GROSS PAYMENT

15.5 The Tenant shall provide the Landlord with its unique taxpayer’s reference number and company registration number and the Landlord shall contact HM Revenue and Customs to verify the Tenant with it within 5 working days following receipt of the same. The Landlord shall make any payment of the Capital Contribution only as directed by HM Revenue and Customs in accordance with section 69 of the Finance Act 2004 and the Income Tax (Construction Industry Scheme) Regulations 2005.

15.6 If HM Revenue and Customs notifies the Landlord that the Tenant’s registration status has changed, then the Landlord shall make any payments of the Capital Contribution after the date of such change only as directed by HM Revenue and Customs in accordance with section 69 of the Finance Act 2004 and the Income Tax (Construction Industry Scheme) Regulations 2005, and this paragraph shall be applied as often as may be required.

15.7 For the avoidance of doubt, it is hereby agreed that any increase in the rental value of the Premises attributable to plant, machinery or other works installed by or on behalf of the Tenant shall, to the extent that the cost of the same is borne by the Capital Contribution, be taken into account on any review of rent under the terms of the Lease.

IN WITNESS of the above the parties have executed this deed the day and year first before written

SCHEDULE 1

Rights granted

1. The right for the Tenant, its employees and licensees in common with the Landlord and all others having the like right for the purpose only of access to and egress from the Premises to pass and repass with or without vehicles over the Access Roads. However, if at any time during the Term in its absolute discretion the Landlord desires to alter, stop up or divert the Access Roads or any part or parts of them the Landlord shall have full right and liberty so to do, but at its own expense and subject to the Landlord leaving available for use by the Tenant reasonable means of access to the Premises.

2. The right for the Tenant in common with the Landlord and all others having the like right of full, free and uninterrupted passage and running of water and soil, gas, electricity and all other services to the Premises through the Conducting Media which are now in, upon, over or under other parts of the Science Park.

3. The right for the Tenant its employees and licensees to park not more than 16 private cars (duly insured and taxed for use on the public highway) in the parking spaces edged green on the plan numbered 3 attached hereto. However, if at any time in the interests of proper estate management the Landlord desires to redesignate all or any of the said parking spaces, the Landlord shall have full right and liberty so to do, but at its own expense and subject to the Landlord making available for use by the Tenant always at least the same number of parking spaces as are edged green on the aforementioned plan.

SCHEDULE 2

Rights reserved

1. The full, free and uninterrupted passage and running of water and soil, gas, electricity and all other services through under and over the Premises for the benefit of the Landlord and the owners, tenants or occupiers for the time being of the adjoining or neighbouring premises through the Conducting Media which are now or may hereafter be in, upon, over or under the Premises.

2. The full and free right and liberty to enter after three working days’ prior notice (except in case of emergency) upon such parts of the Premises as may be necessary at all reasonable times for the purpose of connecting, laying, inspecting, repairing, cleansing, maintaining, amending, altering, replacing, relaying or renewing any Conducting Media and to erect, construct or lay in, under, over or across such reasonable parts of the Premises (as shall be agreed with the Tenant whose agreement shall not be unreasonably withheld or delayed) any Conducting Media, poles, structures, fixtures or other works for the drainage of or for the supply of water, gas, electricity, telephone, heating, steam and other services to any adjoining or neighbouring premises, the person or persons so entering making good all damage thereby occasioned to the Premises.

3. The full and free right and liberty to enter after three working days’ prior notice (except in case of emergency) upon the Premises for the purpose of carrying out any necessary repairs, alterations or improvements to any adjoining or neighbouring premises.

4. All rights of light and air which the Premises enjoy over any other property.

5. The right to deal with, modify or vary all covenants of which the Premises enjoy the benefit Provided that in so doing, the Tenant’s legal use of the Premises shall not be materially adversely affected.

6. All rights of entry in clause 3 of this Lease.

7. The right to erect scaffolding for the purpose of inspecting repairing or cleaning the Premises and any buildings now or after the date of this Lease during the Term on adjoining or neighbouring premises notwithstanding that such scaffolding may temporarily restrict the access of light and air to the Premises.

8. The right to erect any new buildings of any height on adjoining or neighbouring premises in such manner as it shall think fit notwithstanding the fact that the same may obstruct affect or interfere with the amenity of or access to the Premises or the passage of light and air to the Premises.

SCHEDULE 3

Documents to be observed

1. All those documents and matters referred to in the Property and Charges Registers of the Landlord’s freehold title of the Science Park as registered at the Land Registry under title number *** or such other number as the Registrar shall allocate from time to time as at 31 July 2009 (save for any financial charges).

2. Wayleaves granted to British Telecom (and its successors) variously:

2.1 dated May 2002 between *** and British Telecommunications plc (2);

2.2 dated 6 September 2001 between *** and British Telecommunications plc (2);

2.3 dated 24 May 2001 between *** and British Telecommunications plc (2);

2.4 dated 15 February 2001 between Robert Williams, *** and British Telecommunications plc (2);

2.5 dated 13 February 2001 between Robert Williams, *** and British Telecommunications plc (2).

3. Wayleaves granted to The South Eastern Electricity Board variously:

3.1 dated 26 January 1967 between Shell Research Limited (1) and The South Eastern Electricity Board (2);

3.2 dated 15 February 1989 between Shell Research Limited (1) and The South Eastern Electricity Board (2).

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

SCHEDULE 4

Service Charge

Part A

1. The service charge referred to in this Schedule (the “Service Charge”) shall be the Fixed Charge as defined in Schedule 5.

2. The Tenant shall pay the Fixed Charge by equal quarterly payments in advance on the usual quarter days and so in proportion for any broken period.

3. Notwithstanding the other provisions of this Part of this Schedule the first payment of the Fixed Charge for the period from 23 January 2009 to the next quarter day hereafter shall be paid on or before thie date of this Lease.

4. The Landlord shall not be concerned in the administration and collection of or accounting for the Service Charge on an assignment of this Lease and accordingly the Landlord shall:

4.1 not be required to make any apportionment relative to the assignment; and

4.2 be entitled to deal exclusively with the Tenant in whom this Lease is for the time being vested (and for this purpose in disregard of any assignment which has not been registered in accordance with clause 3.20).

Part B

1. The costs and expenses of maintaining, repairing, cleansing, decorating and renewing the Centre Common Parts;

2. The cost of providing security at the Science Park to include (if and as deemed necessary by the Landlord in its discretion) 24 hour manned presence CCTV surveillance security fencing and gates or other equivalent perimeter security measures.

3. All VAT which may be applicable to any of the above services or items save to the extent that the Landlord can recover the same.

SCHEDULE 5

Index-linked review of service charge

1. In this Schedule the following expressions shall have the meanings set opposite them:

“Fixed Charge”	Until 24 December 2010 the Initial Charge and thereafter as determined in accordance with paragraph 2 of this Schedule 5;

“Review Date”	The 25 th day of December 2010 and every anniversary of that date and the date which is one day before the date on with the Term would expire by effluxion of time (disregarding any statutory continuation thereof);

“Initial Charge”	1.	from 23 January 2009 until 22 January 2010 the sum of £10,228 per annum;

	2.	from 23 January 2010 until 22 July 2010 either:

		(a)	£10,228 per annum; or

		(b)	if greater, such yearly sum as bears the same relationship to £20,455 as the area of the Premises actually used by the Tenant bears to the total net internal area of the Premises:

	3.	from 23 July 2010 and at all times thereafter (subject to the provisions of paragraph 2 below), £20,455 per annum.

“Index”	the Index of Retail Prices (All Items) published by H M Government or any equivalent index stated by H M Government to be the official successor to the Index of Retail Prices (All Items)

	PROVIDED that if the method of computation and/or the reference base of the Index shall materially change after the date of this Lease then the figure deemed to be shown in the Index for the purposes of this Lease after such change shall be the figure which would have been shown in the Index if the method of computation and/or reference base current at the date of this Lease had been retained, and any official reconciliation between such differing methods of computation or reference bases shall be binding on the parties to this Lease;

“Relevant Fraction”	A fraction of which the numerator is the figure of the Index published in the four weeks preceding the relevant Review Date and the denominator is the figure of the Index published in December 2009;

“Expert”

An independent chartered accountant (acting as an expert) being a partner in or a director of a leading firm or company of chartered accountants to be nominated in default of agreement by the Landlord and the Tenant by the President for the time being of the Institution of Chartered Accountants in England and Wales on the application of the Landlord or the Tenant made not more than one month before the relevant Review Date.

2. From and including each Review Date the Fixed Charge shall be whichever is the higher of:

(a) the Fixed Charge which was payable immediately before the relevant Review Date (the “Old Charge”); and

(b) the figure calculated by multiplying the Initial Charge by the Relevant Fraction (the “Revised Charge”).

3. If the Landlord and the Tenant shall fail to agree upon the Revised Charge, then either of them may not more than one month before the relevant Review Date require the Revised Charge to be determined by the Expert.

4. The Expert shall on being appointed invite the Landlord and the Tenant to submit to him within such time limits as he shall consider appropriate (but not being less than 21 days) representations and cross representations as to the calculation of the Revised Charge, supported if they so wish by a statement of reasons and/or schedule of calculations. The Expert shall consider such matters submitted to him but shall not be fettered thereby and shall determine the Revised Charge in accordance with his own knowledge, judgment and opinion having regard to such matters as he may consider appropriate. The Expert’s decision shall (save as to any question of law) be final and binding on all matters referred to him under this Lease.

5. If after the date of this Lease it becomes impossible (because of any change in the methods used to calculate the Index, or for any other reason) to calculate the Revised Charge, then the Expert shall have full power to determine what the increase in the Index would have been had it continued on the same basis as is assumed to be available for the operation of this rent review or (if that determination shall also be impossible) shall determine a reasonable charge having regard to the purposes and intent of this Schedule.

6. If the Expert shall die or be unable or unwilling to accept his appointment or to carry out his functions then either the Landlord or the Tenant may apply for a replacement to be appointed in his stead, and this procedure may be repeated as often as necessary.

7. If at any Review Date there is any statutory restriction upon the review or increase of the Fixed Charge or the Landlord’s right to recover it, then at any time after the lifting, removal or modification of such restriction and prior to the next following Review Date the Landlord may give the Tenant not less than one month’s notice requiring an additional review to take place on a quarter day to be specified in such notice which quarter day shall thereupon be treated for the purposes of this Lease as a Review Date.

8. The costs of the Expert and the parties’ costs of the reference to him shall lie in his award but, in the absence of such award, the Landlord and Tenant shall each bear their own costs and one half of the Expert’s costs. One party may pay the costs required to be borne by another party if they remain unpaid for more than 14 days after they become due, and then recover these and any incidental expenses incurred from that other party on demand.

9. Time is not of the essence in relation to any matter contained in this Schedule.

10. If the Revised Charge has not been ascertained by the relevant Review Date, then the Old Charge shall be payable until such time as the Revised Charge has been ascertained.

11. Once the Revised Charge has been ascertained, the Tenant shall on demand pay the Landlord a sum equal to the amount (if any) by which the Revised Charge exceeds the Old Charge for the period from the relevant Review Date until the next quarter day following the date of such demand together with interest on each quarterly shortfall calculated on a daily basis from the date upon which each instalment of the shortfall would have been payable if the Revised Charge had then been ascertained at the base rate of Barclays Bank plc until seven days after the date of such demand, and thereafter together with interest calculated on a daily basis at the rate referred to in clause 5.1(a).

12. The Landlord and the Tenant may at any time settle the Revised Charge in more than one amount and agree to reserve such amounts increasing in steps until the next Review Date or, if none, until the termination of the Term, or as they may otherwise agree.

13. The parties will procure that a memorandum of the Revised Charge signed by the Landlord and Tenant shall be endorsed on or annexed to this Lease and its counterpart.

SCHEDULE 6

Covenants by the Surety

1. The Surety (if any) in consideration of the grant of this Lease (or the agreement to the assignment of this Lease as appropriate) COVENANTS AND GUARANTEES with and to the Landlord that:

1.1 The Tenant shall punctually pay the rents and perform and observe the covenants and other terms of this Lease.

1.2 If the Tenant shall make any default in payment of the rents or in performing or observing any of the covenants or other terms of this Lease the Surety will pay the rents and perform or observe the covenants or terms in respect of which the Tenant shall be in default and make good to the Landlord on demand and indemnify the Landlord against all losses, damages, costs and expenses arising or incurred by the Landlord as a result of such non-payment, non-performance or non-observance notwithstanding:

(a) any time or indulgence granted by the Landlord to the Tenant or any neglect or forbearance of the Landlord in enforcing the payment of the rents or the observance or performance of the covenants or other terms of this Lease;

(b) that the terms of this Lease may have been varied by agreement between the parties;

1.3 These provisions are to take effect immediately on the grant (or the assignment as appropriate) of the Lease to the Tenant and are to remain in force so long and to the extent that the Tenant is not released by law from liability for any of the covenants and other terms of this Lease.

2. The Surety FURTHER COVENANTS with the Landlord that if this Lease is disclaimed or forfeited prior to any lawful assignment by the Tenant of this Lease the Landlord may within six months after the disclaimer or forfeiture by notice in writing require the Surety to accept a new lease of the Premises for a term equivalent to the residue which if there had been no disclaimer or forfeiture would have remained of the Term at the same rent and subject to similar covenants and conditions as are payable under and applicable to the tenancy immediately before the date of such disclaimer or forfeiture (such new lease and the rights and liabilities under it to take effect as from the date of such disclaimer or forfeiture) and in such case the Surety shall pay the Landlord’s costs incurred by the Landlord in connection with such new lease and the Surety shall accept such new lease accordingly and will execute and deliver to the Landlord a counterpart of it.

3. If this Lease is disclaimed or forfeited and for any reason the Landlord does not require the Surety to accept a new lease of the Premises in accordance with paragraph 2 the Surety shall pay to the Landlord on demand an amount equal to the difference between any money received by the Landlord for the use or occupation of the Premises less any expenditure incurred by the Landlord in connection with the Premises and the rents which would have been payable under the Lease but for such disclaimer or forfeiture in both cases for the period commencing with the date of such disclaimer or forfeiture and ending on whichever is the earlier of the following dates:

(a) the date six months after such disclaimer or forfeiture; and

(b) the date (if any) upon which the Premises are relet.

4. The Surety FURTHER COVENANTS and guarantees the obligations of the Tenant under any Authorised Guarantee Agreement entered into by the Tenant pursuant to the terms of this Lease.

5. For the purposes of these provisions references to the Tenant are to the Tenant in relation to whom the Surety’s covenant is given but not any lawful assignee of such Tenant.

6. It is hereby agreed that if any payment is made under the terms of this guarantee and the Surety is thereupon subrogated to all the Landlord’s rights of recovery in relation thereto then the Surety shall not exercise any such rights against the Tenant.

SCHEDULE 7

Authorised Guarantee Agreement

1. The Tenant in consideration of the agreement to the assignment of the Lease COVENANTS AND GUARANTEES with and to the Landlord that:

1.1 The Assignee shall punctually pay the rents and perform and observe the covenants and other terms of the Lease.

1.2 If the Assignee shall make any default in payment of the rents or in performing or observing any of the covenants or other terms of the Lease the Tenant will pay the rents and perform and observe the covenants or terms in respect of which the Assignee shall be in default and make good to the Landlord on demand and indemnify the Landlord against all losses, damages, costs and expenses arising or incurred by the Landlord as a result of such non-payment, non-performance or non-observance notwithstanding:

(a) any time or indulgence granted by the Landlord to the Assignee or any neglect or forbearance of the Landlord in enforcing the payment of the rents or the observance or performance of the covenants or other terms of the Lease;

(b) that the terms of the Lease may have been varied by agreement between the parties (but subject always to section 18 Landlord and Tenant (Covenants) Act 1995);

2. The Tenant FURTHER COVENANTS with the Landlord that if the Lease is disclaimed prior to any lawful assignment by the Assignee of the Lease the Landlord may within six months after the disclaimer require the Tenant to accept a new lease of the Premises for a term equivalent to the residue which if there had been no disclaimer would have remained of the Term at the same rent and subject to similar covenants and conditions as are payable under and applicable to the tenancy immediately before the date of such disclaimer (such new lease and the rights and liabilities under it to take effect as from the date of such disclaimer) and in such case the Tenant shall pay the Landlord’s costs incurred by the Landlord in connection with such new lease and the Tenant shall accept such new lease accordingly and will execute and deliver to the Landlord a counterpart of it.

3. If the Lease is disclaimed and for any reason the Landlord does not require the Tenant to accept a new lease of the Premises in accordance with paragraph 2 the Tenant shall pay to the Landlord on demand an amount equal to the difference between any money received by the Landlord for the use or occupation of the Premises less any expenditure incurred by the Landlord in connection with the Premises and the rents which would have been payable under the Lease but for such disclaimer in both cases for the period commencing with the date of such disclaimer and ending on whichever is the earlier of the following dates:

(a) the date six months after such disclaimer;

(b) the end or sooner determination of the Term.

4. Notwithstanding any of the above provisions the Tenant:

(a) shall not be required to guarantee in any way the liability for the covenants and other terms of the Lease of any person other than the Assignee; and

(b) shall not be subject to any liability, restriction or other requirement (of whatever nature) in relation to any time after the Assignee is by law released from the covenants and other terms of the Lease.

5. No person other than a contracting party may enforce any provision of this Deed by virtue of the Contracts (Rights of Third Parties) Act 1999.

6. It is hereby agreed that if any payment is made under the terms of this guarantee and the Tenant is thereupon subrogated to all the Landlord’s rights of recovery in relation thereto then the Tenant shall not exercise any such rights against the Assignee.

7. Words and expressions used in this Deed shall have the same meaning as in the Lease.

SCHEDULE 8

The Regulations

1. Not to store rubbish or waste of any description outside the Premises save in any area so designated by the Landlord from time to time.

2. Not to allow empty containers or rubbish of any description to accumulate upon the Premises or the Centre Common Parts nor to discharge into the Conducting Media or onto any wall or parking area or forecourt of the Science Park any deleterious matter or substance including chemicals radioactive material diesel fuel or oil which might be or become a source of danger or injury to the Conducting Media or any other property or person.

3. Not to use any container for rubbish or refuse other than such type and so constructed as to prevent any leakage or spillage therefrom and to keep the same in the area (if any) provided for the purpose and to prevent such rubbish or refuse causing a nuisance or annoyance to the Landlord or the owners or occupiers of neighbouring premises.

4. Not to use any part of the Premises in such manner as to subject it to any excessive strain or interference and not to install machinery on the Premises which shall be unduly noisy or cause vibration.

5. Not to do anything on the Premises which might reasonably be expected to produce directly or indirectly corrosive fumes or vapours or moisture or humidity in excess of that which the Premises were designed to bear and are otherwise reasonable.

6. Not to load or unload any vehicle unless the vehicle shall be in a loading area provided from time to time for that purpose and not to obstruct or damage any access ways roads or landscaped areas in the Science Park or leading to the Premises.

7. In the event of a spill or deposit on the Premises of any Hazardous Materials to inform the Landlord of this and permit him to enter and inspect the Premises.

8. To observe the speed limits and traffic signs on the Access Roads.

SIGNED as a deed by VJ Sutcliffe	)	/s/ VJ Sutcliffe
and F.P.A. Giacon	)	/s/ F.P.A. Giacon
as attorneys for Sittingbourne	)
(No. 1) Limited in the presence of:	)


/s/ Charlotte Wright
Name of Witness and Signature


Charlotte Wright
Atlantic House
Holborn Viaduct
London EC1A 2FG

Address


SIGNED as a deed by VJ Sutcliffe	)	/s/ VJ Sutcliffe
and F.P.A. Giacon	)	/s/ F.P.A. Giacon
as attorneys for Sittingbourne	)
(No. 2) Limited in the presence of:	)


/s/ Charlotte Wright
Name of Witness and Signature


Charlotte Wright
Atlantic House
Holborn Viaduct
London EC1A 2FG

Address

EXECUTED as a deed by GW Pharma	)
Limited acting by:	)

Director		/s/ David J. Kirk

Director/Secretary		/s/ Adam George

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

Exhibit 10.27

***Text Omitted and Filed Separately with the Securities and Exchange Commission.

Confidential Treatment Requested under 17 C.F.R. Sections 200.80(b)(4) and 230.406

DATED

6 April 2011

***
- and -
***
- and -

GW PHARMA LIMITED

LEASE

- OF -

***
***
***

Hogan

Lovells

Ref: CM1/CW/VJS/2052279.3

21552/98643

Hogan Lovells International LLP, Atlantic House, Holborn Viaduct. London EC1A 2FG

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

CONTENTS

CLAUSE			PAGE NO

1.	INTERPRETATION		1

2.	DEMISE AND RENT		3

3.	TENANTS’ COVENANTS		3

	3.1	Pay Rent	3

	3.2	Pay outgoings	4

	3.3	Repair and decorate	4

	3.4	Observe legislation	4

	3.5	Yield up	5

	3.6	Entry by Landlord	5

	3.7	Entry by adjoining owners	6

	3.8	Costs of default	6

	3.9	User	6

	3.10	Alterations	7

	3.11	Signage	8

	3.12	Aerials, etc.	8

	3.13	Planning Acts	8

	3.14	Statutory Notices	8

	3.15	Insurer’s requirements	9

	3.16	To Let board	9

	3.17	Prohibited alienation	9

	3.18	Assignment	9

	3.19	Subletting	11

	3.20	Registration of dealings	12

	3.21	Encroachments	12

	3.22	Costs of applications	12

	3.23	Observe documents	13

	3.24	Keyholder	13

	3.25	Environmental Liability	13

4.	LESSOR’S COVENANTS		15

	4.1	Insure	15

	4.2	Quiet enjoyment	15

	4.3	Provide services	15

	4.4	Provision of power water etc.	16

5.	PROVISOS		16

	5.1	Interest on late payments	16

	5.2	Re-entry	17

	5.3	Re-entry	17

	5.4	Statutory compensation	18

	5.5	Data Protection Act 1998	18

	5.6	Exclusion of liability	19

6.	RENT REVIEW		19

7.	TENANT’S OPTION TO DETERMINE		21

8.	ACCIDENTAL HAPPENINGS OR INJURIES		21

9.	NOTICES		21

10.	VAT		22

11.	LANDLORD AND TENANT (COVENANTS) ACT 1995		22

12.	ADDRESS FOR RENT DEMANDS		22

13.	DELIVERY AS A DEED		22

14.	RIGHTS OF THIRD PARTIES		22

SCHEDULES

1.	Rights granted		23

2.	Rights reserved		24

3.	Documents to be observed		25

4.	Service Charge		26

5.	Index-linked review of service charge		27

6.	Covenants by the Surety		30

7.	Authorised Guarantee Agreement		32

8.	The Regulations		34

LAND REGISTRY PRESCRIBED CLAUSES

LR1 Date of lease		6 April 2011

LR2 Title number(s)		LR2.1 Landlord’s title number(s)
		***

		LR2.2 Other title numbers
		None

LR3 Parties to this lease		Landlord
		***** and *** whose registered offices are both at *

		Tenant
		GW PHARMA LIMITED a company registered in England and Wales of (registered number 3704998) whose registered office is at Porton Down Science Park Salisbury Wiltshire SP4 0JQ

		Other parties
		None

LR4 Property		In the case of a conflict between this clause and the remainder of this lease then, for the purposes of registration, this clause shall prevail.

		The Premises as defined in clause 1.1

LR5 Prescribed statements etc		LR5.1 Not applicable

		LR5.2 Not applicable

LR6 Term for which the Property is leased		The Term as defined in clause 1.1

LR7 Premium		None

LR8 Prohibitions or restrictions on disposing of this lease		The lease contains a provision that prohibits or restricts dispositions

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LR9 Rights of acquisition etc		LR9.1 Tenant’s contractual rights to renew this lease, to acquire the reversion or another lease of the Property, or to acquire an interest in other land
		None

		LR9.2 Tenant’s covenant to (or offer to) surrender this lease
		None

		LR9.3 Landlord’s contractual rights to acquire this lease
		None

LR10 Restrictive covenants given in this lease by the Landlord in respect of land other than the Property		None

LR11 Easements		LR11.1 Easements granted by this lease for the benefit of the Property
		The rights and matters set out in Schedule 1

		LR11.2 Easements granted or reserved by this lease over the Property for the benefit of other property
		The rights and matters set out in Schedule 2

LR12 Estate rentcharge burdening the Property		None

LR13 Application for standard form of restriction		None

LR14 Declaration of trust where there is more than one person comprising the Tenant		Not applicable

LEASE

THIS LEASE is made on the date set out in clause LR1

BETWEEN:

(1) the Landlord as set out in clause LR3; and

(2) the Tenant as set out in clause LR3.

1. INTERPRETATION

1.1 In this Lease the following words and expressions have the meanings set opposite them:

“Access Roads” means the roads footpaths and accessways within the Science Park not adopted from time to time and the road connecting the Science Park to ***;

“adjoining or neighbouring premises” includes any part or parts of the Science Park other than the Premises;

“associated company” means a company in the same group of companies as the Tenant as defined by section 42 Landlord and Tenant Act 1954;

“Authorised Guarantee Agreement” means an agreement between the Landlord and the Tenant entered into by the Tenant as covenantor in the circumstances set out in clause 3.18 hereof and containing the provisions set out in Schedule 7 hereto;

“Centre Common Parts” means any entrances, passageways, Access Roads, Conducting Media, car parking, hardstanding, verges, landscaping and other parts of the Science Park available or intended to be available for use and/or enjoyment by two or more of the Landlord’s tenants of the Science Park in common (but for the avoidance of doubt including all car parking areas whether or not the subject of exclusive parking rights);

“Conducting Media” means tanks, pipes, cables, wires, meters, drains, sewers, gutters and other things of a similar nature for the passage of electricity, gas, water, soil and other services;

“Environmental Audit” means an audit of the Tenant’s Activities on the Premises to be commissioned by the Landlord from time to time but not more than once per year;

“Gateway Tenant” means an individual, partnership or company whose prime activity either is within the areas of Science or High Technology or is the provision of support directly related to the scientific community as would maintain an appropriate mix of tenants at the Science Park to retain its character as a science park in the opinion of the Landlord acting in the interests of good estate management;

“High Technology” means research, development, design, manufacturing or service activities utilising, employing or manufacturing product or processes which apply biotechnology, electronics, robotics, informatics or other such scientific disciplines as the Landlord (in conjunction with the local planning authority) determines to be representative of the field of high technology;

“Insurance Rent” means the rent reserved by clause 2.2 ;

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“Insured Risks” means fire and such other risks or perils (if any) as the Landlord or any superior landlord may from time to time deem it prudent to insure and have insured the Science Park (with or without the boilers, lifts and other plant and machinery in the Science Park) against;

“Landlord” includes the person or persons for the time being entitled to the reversion immediately expectant on the Term;

“Planning Acts” means and includes the “planning Acts” as defined in section 117 Planning and Compulsory Purchase Act 2004 together with that Act and all other legislation from time to time imposing controls on the development or use of land;

“Premises” means the premises (shown edged red on the plan numbered 1 annexed hereto and shown for the purposes of locating the same within the Science Park only edged red on the plan numbered 2 annexed hereto) known as *** as well as any landlord’s fixtures and fittings from time to time in the Premises and each and every part of the Premises;

“Regulations” means the regulations set out in Schedule 8 hereto;

“Rent” means the rent reserved by this Lease at the rate from time to time payable under clause 2.1 and clause 6;

“Science” means dependence upon the application of scientific or technological skills or knowledge in the production of new goods or services for competitive advantage;

“Science Park” means ***, *** and any other land from time to time owned by the Landlord which is adjoining or neighbouring;

“Service Charge” means the Service Charge as defined in and calculated pursuant to Schedule 4;

“Tenant” includes the successors in title and assigns of the Tenant;

“Term” means a term of years commencing on 30 March 2011 and expiring on 22 January 2019 together with any statutory continuation;

“VAT” means Value Added Tax and any other tax of a similar nature.

1.2 In this Lease unless there be something in the context inconsistent therewith:

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(d) where the Tenant is placed under a restriction by this Lease it includes an obligation not to permit or allow the restriction to be infringed;

(e) references to “lease” shall include “underlease” and vice versa.

***

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***

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

***

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2. DEMISE AND RENT

2.1 Until 30 March 2016 the yearly rent of £96,100 and during the remainder of the Term the same yearly rent or such higher yearly rent as may become payable pursuant to review under clause 6 by equal quarterly payments in advance on the four usual quarter days in each year of which the first payment (being the due proportion for the period commencing on 30 March 2011 and ending on the usual quarter day thereafter) shall be paid on or before the date of this Lease.

2.2 throughout the Term sums equal to a just proportion fairly attributable to the Premises of the total amounts which the Landlord shall from time to time expend by way of premium and incidental costs (including the cost of periodic valuations and any premium payable under any headlease and the whole of any increase in any premium from time to time as a result of or arising out of the manner or the purposes in or for which the Premises are kept used and occupied) in effecting and maintaining the several insurances referred to in clause 4.1 (together with any insurance effected by the Landlord against public liability risks in respect of the Science Park) each such sum to be paid immediately following a demand the first such payment in respect of amounts already so expended by the Landlord (being the due proportion commencing on 30 March 2011 to the next renewal date or dates for such insurances) to be paid on or before the date of this Lease and in the event of any dispute as to any such sum the same shall be determined by the Landlord’s surveyor (acting as an independent expert and not as an arbitrator) whose determination shall be final and binding on the parties;

2.3 throughout the Term sums equal to the Service Charge defined at the times and in the manner specified in Schedule 4;

2.4 VAT on the rents reserved by this Lease payable at the time such rents are payable.

3. TENANTS’ COVENANTS

The Tenant to the intent that the obligations hereby created shall continue throughout the whole of the Term HEREBY COVENANTS with the Landlord as follows:

3.1 Pay Rent

3.2 Pay outgoings

3.3 Repair and decorate

(Damage by the Insured Risks always excepted unless the policy or policies of insurance effected by the Landlord against them shall be rendered void or payment of the insurance moneys be refused in whole or in part by reason of or arising out of any act, omission, neglect or default by the Tenant or any subtenant or other person under the control of the Tenant or any subtenant) to keep the Premises including all means of escape therefrom in case of fire or other emergency and Conducting Media forming part of and serving the Premises in good and substantial repair and condition and maintained and in good decorative and clean condition (but not in any better condition than as evidenced by the Schedule of Condition annexed hereto) with the glass cleaned both inside and (unless the cost of the same is being met by the Tenant as part of the Service Charge) outside at least once a month and (without prejudice to the generality of the above obligations of the Tenant) in a good and workmanlike manner and to the reasonable satisfaction of the Landlord in the year 2016 and every fifth year thereafter and also in the last three months of the Term (however and whenever it may terminate) to paint with at least two coats of good quality paint all interior parts of the Premises which have previously been or ought to be painted and grain varnish paper or otherwise suitably decorate or treat with good quality materials as circumstances may require all parts of the interior of the Premises which have previously been or ought to be so dealt with and in the case of painting in the last three months of the Term the Landlord shall have the right to insist on a particular colour scheme being used.

3.4 Observe legislation

(a) To observe and perform all requirements of any Act of Parliament, local Act or bylaw and notices issued under such legislation or by any public, local or other competent authority (whether or not required of the Tenant himself) in any way affecting the Premises or any thing in or any activity carried on by persons resorting to or working or employed at the Premises or the use and occupation of the Premises within the time limited by law or the notice requiring the same (or if no time is so limited then within a reasonable time) to the reasonable satisfaction of the Landlord and to indemnify and keep the Landlord fully indemnified against all such requirements and all actions, proceedings, costs, claims, demands, expenses and liability whatever arising out of or in connection with nonobservance or non-performance of such requirements.

(d) In particular but without prejudice to the generality of the foregoing to comply with all the lawful requirements from time to time of the following bodies or their successors:

(i) the Health and Safety Executive;

(ii) Environmental Agency;

(iii) Home Office;

(iv) Her Majesty’s Inspector of Pollution;

(v) Department of Health and Social Security;

(vi) ***;

(vii) Customs and Excise;

(viii) Department for Environment Food and Rural Affairs;

(ix) National Radiological Protection Board.

3.5 Yield up

(a) unless otherwise required by the Landlord, at the Tenant’s expense to remove from the Premises any alterations or additions to the Premises made during the Term or during the subsistence of any previous lease or tenancy of the Premises held by the original Tenant under this lease, where such lease or tenancy contained an obligation to reinstate such alterations or additions, including without limitation and for the avoidance of doubt, during the term of a lease dated 11 April 2001 and made between *** and GW Pharmaceuticals Limited (2); and

(b) to hand over to the Landlord all keys relating to the Premises.

3.6 Entry by Landlord

(a) To permit the Landlord and others authorised by the Landlord after at least three days’ prior notice (except in an emergency when no notice need be given) to enter upon the

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Premises to view and inspect the Premises and ascertain how the same are being used and occupied and their state and condition and to take schedules of all landlord’s fixtures and fittings and to estimate the current value of the Premises for insurance, mortgage or other purposes and to carry out an Environmental Audit.

3.7 Entry by adjoining owners

3.8 Costs of default

(b) any notice to repair or schedule of dilapidations accrued at or prior to the end or sooner determination of the Term whether or not served during the Term;

and in default of payment all such sums shall be recoverable as rent in arrears.

3.9 User

(a) The Premises shall be kept used and occupied only for manufacture and research within Class B1 of the Town and Country Planning (Use Classes) Order 1987 (as in force at the

date of the agreement for lease pursuant to which this lease was entered into) and ancillary storage and not in any other manner or for any other purpose or for any immoral or unlawful purpose or for any sale by auction and the Tenant acknowledges that nothing in this Lease constitutes a warranty that the above use complies with or will continue to comply with the Planning Acts and the Tenant shall not be entitled to any relief or compensation whatsoever from the Landlord in that respect.

(c) Neither the Tenant nor any subtenant nor any person in occupation of the Premises shall carry out on or from the Premises research into or involving any of the following:

(i) genetic modification within the meaning of Directive 2001/18/EC;

(ii) human embryology within the meaning of the Human Fertilisation and Embryology Act 1990 (as amended); and/or

3.10 Alterations

addition or other works of or to the Premises which do not so conform or in respect of which any such approvals, consents, licences, permits or permissions of the competent authority, body or person has been withdrawn or has lapsed and thereupon make good all damage caused to the Premises and restore and reinstate all affected parts of the Premises to the reasonable satisfaction of the Landlord.

3.11 Signage

3.12 Aerials, etc

3.13 Planning Acts

3.14 Statutory Notices

To give the Landlord a copy of every notice of whatsoever nature affecting or likely to affect the Premises made given or issued by or on behalf of the local planning authority or any other authority, body or person having lawful jurisdiction within seven days of its receipt by the Tenant or any subtenant and to produce the original to the Landlord on written request and to take all reasonable and necessary steps to comply with every such notice And if so required in writing by or on behalf of the Landlord to make or join with the Landlord and any other persons for the time being interested in the Premises or any adjoining or neighbouring premises in making such objections or representations against or in respect of any such notice as the Landlord may reasonably require.

3.15 Insurer’s requirements

(b) To repay to the Landlord upon written demand as part of the Insurance Rent an amount equal to any such increased premium as may become so payable.

3.16 To Let board

3.17 Prohibited alienation

3.18 Assignment

(a) Not to assign the whole of the Premises without the prior written consent of the Landlord (such consent not to be unreasonably withheld or delayed) provided that the Landlord shall be entitled:

(i) to withhold its consent in any of the circumstances set out in subclause (c);

(ii) to impose all or any of the matters set out in subclause (d) as a condition of its consent.

grant of consent where the imposition of such condition or conditions would be reasonable.