UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 20-F/A
(Amendment No. 2)
(Mark One) |
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REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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OR |
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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OR |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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OR |
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SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Date of event requiring this shell company report
Commission file number 001-37710
HUTCHISON CHINA MEDITECH LIMITED |
(Exact name of Registrant as specified in its charter) |
N/A |
(Translation of Registrants name into English) |
Cayman Islands |
(Jurisdiction of incorporation or organization) |
48th Floor, Cheung Kong Center |
2 Queens Road Central |
Hong Kong |
+852 2121 8200 |
(Address of principal executive offices) |
Christian Hogg |
Chief Executive Officer |
Level 18, The Metropolis Tower |
10 Metropolis Drive |
Hunghom, Kowloon |
Hong Kong |
Telephone: +852 2121 8200 |
Facsimile: +852 2121 8281 |
(Name, telephone, email and/or facsimile number and address of Company contact person) |
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class |
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Trading Symbol(s) |
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Name of the Exchange
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American depositary shares, each representing one-half of one ordinary share, par value $1.00 per share |
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HCM |
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Nasdaq Global Select Market |
Securities registered or to be registered pursuant to Section 12(g) of the Act:
None |
(Title of Class) |
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act:
None (Title of Class) |
Indicate the number of outstanding shares of each of the issuers classes of capital or common stock as of the close of the period covered by the Annual Report:
66,657,745 ordinary shares were issued and outstanding as of December 31, 2018.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
x Yes o No
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.
o Yes x No
Notechecking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 from their obligations under those sections.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
x Yes o No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
x Yes o No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of large accelerated filer,accelerated filer, and emerging growth company in Rule 12b-2 of the Exchange Act.
Large accelerated filer x |
Accelerated filer o |
Non-accelerated filer o |
Emerging growth company o |
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
The term new or revised financial accounting standard refers to any update issued by the Financial Accounting Standards Board to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP x |
International Financial Reporting Standards as issued
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Other o |
If Other has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow.
o Item 17 o Item 18
If this is an Annual Report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). o
o Yes x No
Explanatory Note
This Amendment No. 2 (this Amendment ) to our annual report on Form 20-F for the fiscal year ended December 31, 2018 (the Form 20-F ) is being filed solely to replace Exhibits 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.10 and 4.11, which were incorporated by reference in Item 19Exhibits of the Form 20-F, with the corresponding exhibits attached to this Amendment (collectively, the Revised Exhibits ). Portions of each of the Revised Exhibits have been omitted in reliance on the recent revisions to Item 601(b)(10) and (b)(2) of Regulation S-K, governing redaction of confidential information in material contracts (the Reg S-K Revisions ).
The Revised Exhibits were originally filed as Exhibits 10.9, 10.10, 10.11, 10.12, 10.13, 10.14, 10.18 and 10.19, respectively, to the Companys Registration Statement on Form F-1 filed on October 16, 2015, as amended, which omitted the same information pursuant to the confidential treatment request process of the Securities and Exchange Commission (the SEC ) in effect prior to the Reg S-K Revisions. Based on consultations with the staff of the SEC (the Staff ), we were advised that we could furnish such exhibits pursuant to the Reg S-K Revisions on a current report on Form 6-K and concurrently amend our Form 20-F to incorporate these exhibits by reference to such Form 6-K, which we did on May 2, 2019. Subsequently, the Staff provided us with updated guidance that the Staff had determined that Form 6-K could not be used for this purpose under the Reg S-K Revisions and that we should instead file the Revised Exhibits by way of this second Amendment to our Form 20-F.
Additionally, in connection with the filing of this Amendment, the Company is including certifications of the Companys Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(a) of the Exchange Act. The Company is not including certifications pursuant to Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350) as no financial statements are being filed with this Amendment. Except for the Revised Exhibits, this Amendment does not amend any other information set forth in the Form 20-F. This Amendment speaks as of the original filing date of the Form 20-F, does not reflect any events that may have occurred subsequent to such date, and does not modify or update in any way any disclosures made in the Form 20-F, except with respect to the Revised Exhibits.
PART III
ITEM 19. EXHIBITS
The exhibits filed herewith or incorporated into this Amendment are listed in the indext of exhibits below:
EXHIBIT INDEX
1.1* |
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2.1* |
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2.2* |
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2.3* |
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4.1** + |
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4.2** + |
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4.3** + |
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4.4** + |
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4.5** + |
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4.6** + |
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4.7* |
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4.8* |
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4.9* |
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4.10** + |
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4.11** + |
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4.12* |
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4.13* |
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4.14* |
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4.15* # |
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4.16* + |
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8.1* |
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12.1** |
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Certification of Chief Executive Officer Required by Rule 13a-14(a) |
12.2** |
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Certification of Chief Financial Officer Required by Rule 13a-14(a) |
13.1 |
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13.2 |
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15.1* |
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15.2* |
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15.3* |
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15.4* |
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15.5* |
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101.INS* |
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XBRL Instance Document |
101.SCH* |
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XBRL Taxonomy Extension Schema Document |
101.CAL* |
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XBRL Taxonomy Extension Calculation Linkbase Document |
101.LAB* |
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XBRL Taxonomy Extension Label Linkbase Document |
101.PRE* |
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XBRL Taxonomy Extension Presentation Linkbase Document |
101.DEF* |
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XBRL Taxonomy Extension Definitions Linkbase Document |
* Previously filed.
** Filed herewith.
Furnished previously.
# Confidential treatment previously requested and granted as to portions of the exhibit. Confidential materials have been submitted separately to the Securities and Exchange Commission.
+ Portions of this exhibit have been omitted because they are both (i) not material and (ii) would likely cause competitive harm to the Company if publicly disclosed.
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on annual report on Form 20-F/A and that it has duly caused and authorized the undersigned to sign this annual report on its behalf.
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Hutchison China MediTech Limited |
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By: |
/s/ Christian Hogg |
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Name: |
Christian Hogg |
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Title: |
Chief Executive Officer |
Date: May 30, 2019 |
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THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
LICENSE AND COLLABORATION AGREEMENT
by and between
和 记黄埔医药(上海)有限公司 HUTCHISON MEDIPHARMA LIMITED
and
ASTRAZENECA AB (PUBL)
December 21st, 2011
TABLE OF CONTENTS
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1. |
DEFINITIONS |
1 |
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2. |
SCOPE OF COLLABORATION AND GRANT OF LICENSES |
15 |
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2.1. |
Scope of Collaboration |
15 |
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2.2. |
License to AstraZeneca |
15 |
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2.3. |
License to Hutchison |
15 |
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2.4. |
Joint Technology |
16 |
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2.5. |
Sublicensing |
16 |
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2.6. |
Right of Reference |
17 |
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2.7. |
Delivery of Hutchison Know-How |
18 |
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2.8. |
Delivery of AstraZeneca Know-How |
18 |
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2.9. |
No Other Rights |
18 |
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3. |
DECISION MAKING AND DISPUTE RESOLUTION |
18 |
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3.1. |
Joint Steering Committee |
18 |
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3.2. |
Other Committees |
20 |
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3.3. |
Elevation and Dispute Resolution |
21 |
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4. |
DEVELOPMENT, REGULATORY, COMMERCIALIZATION |
22 |
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4.1. |
Development of Collaboration Product and Diagnostic Product |
22 |
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4.2. |
Failure of Collaboration Product |
23 |
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4.3. |
Regulatory Matters |
24 |
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4.4. |
Manufacture |
25 |
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4.5. |
Commercialization |
26 |
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4.6. |
Phase IV and Publication Strategy |
27 |
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5. |
CONSIDERATION |
28 |
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5.1. |
Upfront Payments |
28 |
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5.2. |
Milestones |
28 |
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5.3. |
Royalties |
30 |
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5.4. |
Sales Subject to Royalties |
30 |
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5.5. |
Fully Paid-Up, Royalty Free License |
31 |
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5.6. |
Third Party Intellectual Property |
31 |
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5.7. |
Development Costs |
32 |
TABLE OF CONTENTS (CONTINUED)
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5.8. |
Reports and Payments |
34 |
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6. |
COVENANTS |
38 |
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6.1. |
Confidentiality |
38 |
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6.2. |
Compliance with Law |
40 |
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6.3. |
Exclusivity |
42 |
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6.4. |
Non-Solicitation |
46 |
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7. |
REPRESENTATIONS AND WARRANTIES |
46 |
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7.1. |
Representations and Warranties of Each Party |
46 |
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7.2. |
Additional Representations and Warranties of Hutchison |
46 |
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7.3. |
Representation by Legal Counsel |
47 |
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7.4. |
No Inconsistent Agreements |
47 |
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7.5. |
Disclaimer |
48 |
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8. |
INTELLECTUAL PROPERTY |
48 |
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8.1. |
Disclosure |
48 |
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8.2. |
Ownership |
48 |
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8.3. |
JIPC |
48 |
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8.4. |
Filing, Prosecution and Maintenance of Patent Rights |
49 |
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8.5. |
Trademarks |
50 |
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8.6. |
Enforcement of Technology Rights |
50 |
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8.7. |
Third Party Claims |
51 |
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8.8. |
Patent Certifications |
52 |
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8.9. |
No Implied Licenses |
52 |
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8.10. |
Privileged Communications |
52 |
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8.11. |
Create Act |
52 |
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9. |
GOVERNMENT APPROVALS |
52 |
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9.1. |
AstraZenecas and Hutchisons Obligations |
52 |
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9.2. |
Additional Approvals |
53 |
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9.3. |
Termination |
53 |
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10. |
TERM AND TERMINATION |
53 |
TABLE OF CONTENTS (CONTINUED)
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10.1. |
Term |
53 |
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10.2. |
Termination for Convenience; Termination by Mutual Agreement |
53 |
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10.3. |
Termination for Cause |
53 |
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10.4. |
Effect of Termination |
54 |
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10.5. |
Rights in Bankruptcy |
57 |
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10.6. |
Survival of Certain Obligations |
57 |
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11. |
PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE |
57 |
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11.1. |
Indemnification by Hutchison |
57 |
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11.2. |
Indemnification by AstraZeneca |
58 |
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11.3. |
Procedure |
58 |
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11.4. |
Insurance |
60 |
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11.5. |
Liability Limitations |
60 |
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12. |
MISCELLANEOUS |
60 |
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12.1. |
Governing Law, Jurisdiction; Dispute Resolution |
60 |
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12.2. |
Force Majeure |
62 |
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12.3. |
Waiver and Non-Exclusion of Remedies |
63 |
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12.4. |
Notices |
63 |
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12.5. |
Entire Agreement |
64 |
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12.6. |
Amendment |
64 |
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12.7. |
Assignment |
64 |
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12.8. |
No Benefit to Others |
65 |
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12.9. |
Counterparts |
65 |
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12.10. |
Severability |
65 |
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12.11. |
Further Assurance |
65 |
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12.12. |
Publicity |
65 |
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12.13. |
Relationship of the Parties |
65 |
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12.14. |
Subcontracting |
66 |
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12.16. |
Construction |
66 |
LICENSE AND COLLABORATION AGREEMENT
This LICENSE AND COLLABORATION AGREEMENT (the Agreement ) is entered into on this 21st day of December, 2011 (the Effective Date ), by and among 和 记黄埔医药(上海)有限公司 Hutchison Medipharma Limited, a company organized under the laws of the Peoples Republic of China, having its place of business at Building 4, 720 Cailun Road, Zhangjiang Hi-Tech Park, Shanghai 201203, P.R. China ( Hutchison ) and AstraZeneca AB(publ) , a company organized under the laws of Sweden, having its place of business at S-151 85 Södertälje, Sweden ( AstraZeneca ). Hutchison and AstraZeneca may each be referred to herein individually as a Party and collectively as the Parties .
RECITALS
WHEREAS, Hutchison owns or otherwise controls certain patents, patent applications, technology, know-how, scientific and technical information and other proprietary rights and information relating to the research, development and manufacture of the c-Met inhibitor known as HMPL-504;
WHEREAS, AstraZeneca is engaged in the research, development and commercialization of pharmaceutical products;
WHEREAS, Hutchison and AstraZeneca desire to collaborate, on an exclusive basis, in the development and commercialization of pharmaceutical products targeting the Collaboration Target (as defined below) and to collaborate specifically on the development and commercialization of the Collaboration Compound and Collaboration Product (as defined below); and
WHEREAS, subject to the terms of this Agreement, Hutchison wishes to grant to AstraZeneca, and AstraZeneca wishes to receive from Hutchison, an exclusive license to develop, manufacture and commercialize the Collaboration Compound and Collaboration Product in the Field (as defined below).
AGREEMENT
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
1. DEFINITIONS.
1.1. Abbreviated New Drug Application or ANDA means an Abbreviated New Drug Application as defined in the FD&C Act and the regulations promulgated thereunder which references an NDA.
1.2. Adverse Event means any adverse medical occurrence in a patient or clinical investigation subject that is administered a pharmaceutical product, as designated in the United States of America under 21 CFR § 312.32 and any
other Applicable Law.
1.3. Affiliate(s) means, with respect to a Person, any Person that controls, is controlled by, or is under common control with such first Person. For purposes of this definition only, control means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or (b) to own, directly or indirectly, more than fifty percent (50%) of the outstanding voting securities or other ownership interests of such Person.
1.4. API Manufacturing means the Manufacture and supply of Collaboration Compound for inclusion in a Collaboration Product Developed and Commercialized in accordance with this Agreement.
1.5. AstraZeneca Indemnified Party has the meaning set forth in Section 11.1.
1.6. AstraZeneca Know-How means Collaboration Know-How (other than Joint Know-How) that is conceived or developed or, in the case of patentable Know-How, Invented solely by employees of AstraZeneca or its Affiliates, or Third Parties acting on behalf of AstraZeneca or its Affiliates.
1.7. AstraZeneca Patent Rights means any Patent Right that AstraZeneca Controls as of the Effective Date or that come into the Control of AstraZeneca during the Term (other than Joint Patent Rights or Patent Rights which are Hutchison Patent Rights licensed to AstraZeneca pursuant to this Agreement) to the extent such rights (a) claim a Collaboration Compound or Collaboration Products, any method of making a Collaboration Compound or Collaboration Products, any composition or formulations of a Collaboration Compound or Collaboration Products or any method of using or administering a Collaboration Compound or Collaboration Products and (b) are actually used by AstraZeneca to Manufacture, Develop or Commercialize a Collaboration Compound or Collaboration Products.
1.8. AstraZeneca Technology means AstraZenecas interest in (i) the AstraZeneca Know-How, and (ii) the AstraZeneca Patent Rights, and all other intellectual property rights in any of the foregoing.
1.9. Agreement Compound means any compound with a molecular weight less than 1000 Da, other than a Collaboration Compound, that specifically targets the Collaboration Target and lacks material activity against other pharmaceutical targets (i.e. the IC50 value of such compound or product against another pharmaceutical target is more than thirty (30) times greater than the IC50 value of such compound or product against the Collaboration Target).
1.10. Applicable Laws means all applicable statutes, ordinances, regulations, rules, or orders of any kind whatsoever of any Regulatory Authority, including the FD&C Act, Prescription Drug Marketing Act, Generic Drug Enforcement
Act of 1992 (21 U.S.C. § 335a et seq.), and Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.) and all counterparts thereto in other jurisdictions, all as amended from time to time.
1.11. Back-Up Compound means any Agreement Compound Controlled by a Party, which Agreement Compound exists on the Effective Date or is discovered or invented during the Term. Back-Up Compounds in existence on the Effective Date are set forth in Schedule 1.11
1.12. Calendar Quarter means each of the three (3) consecutive month periods ending on March 31, June 30, September 30, and December 31.
1.13. Calendar Year means each twelve (12) month period ending December 31st.
1.14. China means the Peoples Republic of China, including Hong Kong and Macau.
1.15. China Development Activities has the meaning set forth in Section 5.7.1(a).
1.16. Change of Control means, with respect to Hutchison, the occurrence of (a) any one of the following events: (i) a Third Party acquires, directly or indirectly, shares of Hutchison representing fifty percent (50%) or more of the voting shares (where voting refers to being entitled to vote for the election of directors) then outstanding of Hutchison; (ii) Hutchison consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into Hutchison, in either event pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger are not held by the holders of the outstanding voting shares of Hutchison preceding such consolidation or merger; or (iii) Hutchison conveys, transfers or leases all or substantially all of its assets to a Third Party and (b) such acquiring or merging Third Party has an Agreement Compound which is in clinical development at the time of closing of such Change of Control (a Competing Product ), and such Competing Product is not the subject of a divestiture committed to under Section 6.4.2.
1.17. Clinical Trial means a human clinical study conducted on sufficient numbers of human subjects that is designed to (a) establish that a pharmaceutical product is reasonably safe for continued testing, (b) investigate the safety and efficacy of the pharmaceutical product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product in the dosage range to be prescribed or (c) support Regulatory Approval of such pharmaceutical product or label expansion of such pharmaceutical product.
1.18. Collaboration Target means [**].
1.19. Collaboration Compound means Hutchisons proprietary compound designated by Hutchison on the Effective Date as HMPL-504, as more fully described in Schedule 1.19 and as improved or modified in connection with this Agreement, [**].
1.20. Collaboration Know-How means Know-How that is conceived or developed or, in the case of patentable Know-How, Invented, by or on behalf of either or both Parties (or their Affiliates) employees or Third Parties acting on such Parties behalf, in each case in the course of such Partys performance under or in connection with this Agreement. For avoidance of doubt, Collaboration Know-How excludes any Know-How Controlled by a Party as of the Effective Date.
1.21. Collaboration Patent Rights means Patent Rights claiming Collaboration Know-How. For avoidance of doubt, Collaboration Patent Rights excludes any Patent Rights Controlled by a Party as of the Effective Date.
1.22. Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.
1.23. Collaboration Technology means Collaboration Know-How and Collaboration Patent Rights, and all other intellectual property rights in any of the foregoing.
1.24. Combination Collaboration Product means a pharmaceutical product containing as its active ingredients both a Collaboration Compound and one or more other therapeutically or prophylactically active ingredients combined in a single product.
1.25. Commercialization means any and all activities of using, importing, marketing, promoting, distributing, offering for sale or selling a Collaboration
Product including pre-commercial launch market development activities conducted in anticipation of Regulatory Approval of a Collaboration Product, seeking pricing and reimbursement approvals for a Collaboration Product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority regarding Post-Approval Clinical Trials and all activities required to fulfill ongoing regulatory obligations, including Adverse Event reporting. When used as a verb, Commercialize means to engage in Commercialization.
1.26. Commercially Reasonable Efforts means, with respect to a Party, those efforts and resources that such Party would reasonably devote to a product or compound owned by it or to which it has rights of the type it has hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account the competitiveness of the global and local marketplace, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), the pricing and launching strategy for the respective product, the proprietary position of the product, the profitability and the relative potential safety and efficacy of the product and other relevant factors, including technical, legal, scientific, regulatory or medical factors, all as measured by the facts and circumstances at the time such efforts are due. Commercially Reasonable as used herein shall be interpreted in a corresponding manner.
1.27. Confidential Information means, with respect to a Party, all information (and all tangible and intangible embodiments thereof), which is Controlled by such Party, is disclosed by such Party to the other Party pursuant to this Agreement, and is designated as confidential in writing by the disclosing Party whether by letter or by use of an appropriate stamp or legend, prior to or at the time any such information is disclosed by the disclosing Party to the other Party. In addition, any information which is orally, electronically or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp or legend, shall constitute Confidential Information if the disclosing Party, within thirty (30) days after such disclosure, delivers to the receiving Party a written document or documents describing the information disclosed and referencing the place and date of such oral, visual, electronic or written disclosure and the names of the person(s) to whom such disclosure was made; provided , however , that any technical information disclosed at a meeting of the JSC or any other committee established pursuant to this Agreement shall constitute Confidential Information unless otherwise specified.
1.28. Control or Controlled means, with respect to any intellectual property right, information, documents or materials of a Party, that the Party or its Affiliate owns or has a license to such intellectual property right, information, documents or materials (other than pursuant to this Agreement) and has the ability to grant access, a license, or a Sublicense to such intellectual property right, information, documents or materials to the other Party as provided in this Agreement without violating an agreement with or other rights of any Third
Party; it being understood and agreed that the term Control shall not apply to any intellectual property right for which the licensing Party shall be required to make any payments to any Third Party in connection with the licenses granted under this Agreement unless, but only if and for such time that, the other Party agrees and does promptly pay to the licensing Party all such payments arising out of the grant of the license to the other Party (as so mutually agreed between the Parties in good faith).
1.29. Country-Specific Termination has the meaning set forth in Section 10.3.1.
1.30. Designated Manufacturer has the meaning set forth in Section 4.4.1.
1.31. Development means all activities performed by or on behalf of either Party in the performance of any Development Plan for Collaboration Compounds, Collaboration Products and Diagnostic Products in the Fields. Development shall include, without limitation, Translational Research Activities and all activities related to research, preclinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis, report writing performed pursuant to the Development Plan with respect to Collaboration Products. Development shall not include Manufacturing or Commercialization. When used as a verb, Develop means to engage in Development.
1.32. Development Budget means the written budget that sets forth, for the time period covered by the Development Plan, the total budget for the Parties to perform activities pursuant to the Development Plan. The initial Development Budget is attached hereto as Schedule 1.32 and may be amended from time to time by the Parties in accordance with Section 4.1.1 .
1.33. Development Plan means the comprehensive plan for the Development of Collaboration Products for Regulatory Approval in the Field in the Territory, prepared and approved by the JSC (subject to Section 3.3) and as amended or updated from time to time as set forth in Section 4.1.1. The Development Plan shall include, without limitation, (a) an allocation of responsibilities for Development activities to be undertaken by each Party, consistent with the terms of this Agreement; (b) the Development Budget; (c) the indications in the Field for which the Collaboration Product is to be Developed; and (d) other critical activities to be undertaken, timelines, key decision points and relevant decision criteria.
1.34. Diagnostic Product means a diagnostic tool intended for use in connection with a Collaboration Product.
1.35. Disclosing Party has the meaning set forth in Section 6.1.1.
1.36. Effective Date means the date of this Agreement first set forth above.
1.37. Exclusivity Period has the meaning set forth in Section 6.4.1.
1.38. FD&C Act means the United States of America Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder.
1.39. FDA means the United States of America Food and Drug Administration or any successor agency thereto.
1.40. Field means all diagnostic, prophylactic and therapeutic uses of a Collaboration Product, in any formulation or dosage form, for any and all indications in humans.
1.41. Financial Records has the meaning set forth in Section 5.8.6.
1.42. First Commercial Sale means, with respect to a Collaboration Product and any country of the Territory, the first sale of such Collaboration Product under this Agreement for use in the Field to a Third Party in such country, after such Collaboration Product has been granted Regulatory Approval by the competent Regulatory Authorities in such country.
1.43. Force Majeure has the meaning set forth in Section 12.2.
1.44. GAAP means United States of America generally accepted accounting principles, as in effect from time to time.
1.45. Generic Product means, on a country-by-country basis and Collaboration Product-by-Collaboration Product basis, a drug product independently developed and commercialized by a Third Party that (a) contains the same active pharmaceutical ingredient(s) as the Collaboration Product, (b) [**] and, (c) (i) for purposes of the United States, is approved in reliance on the prior Regulatory Approval of such Collaboration Product, as determined by the FDA, or, (ii) for purposes of a country outside the United States, is approved in reliance on the prior Regulatory Approval of such Collaboration Product, as determined by the applicable Regulatory Authority.
1.46. Government Authority means any court, agency, department, authority or other instrumentality of any national, state, county, city or other political subdivision.
1.47. Hutchison Indemnified Party has the meaning set forth in Section 11.2.
1.48. Hutchison Know-How means (a) Know-How that is Controlled by Hutchison as of the Effective Date or that comes into the Control of Hutchison during the Term (other than Joint Know-How and Know-How which is AstraZeneca Know-How licensed to Hutchison pursuant to this Agreement) to the extent necessary or useful to Manufacture, Develop or Commercialize a
Collaboration Compound or Collaboration Product, including any method of making a Collaboration Compound or Collaboration Product, any composition or formulations of a Collaboration Compound or Collaboration Product or any method of using or administering a Collaboration Compound or Collaboration Product and (b) Collaboration Know-How (other than Joint Know-How) that is conceived or developed or, in the case of patentable Know-How, Invented, solely by employees of Hutchison or its Affiliates, or Third Parties acting on behalf of Hutchison or its Affiliates.
1.49. Hutchison Patent Rights means any Patent Right that is Controlled by Hutchison as of the Effective Date or that comes into the Control of Hutchison during the Term (other than Joint Patent Rights and Patent Rights which are AstraZeneca Patent Rights licensed to Hutchison pursuant to this Agreement) to the extent such rights claim a Collaboration Compound or Collaboration Product, any method of making a Collaboration Compound or Collaboration Product, any composition or formulations of a Collaboration Compound or Collaboration Product or any method of using or administering a Collaboration Compound or Collaboration Product. The Hutchison Patent Rights existing as of the Effective Date are set forth on Schedule 1.49 .
1.50. Hutchison Technology means Hutchisons interest in (a) the Hutchison Know-How and (b) the Hutchison Patent Rights, and all other intellectual property rights in any of the foregoing.
1.51. IFRS means International Financial Reporting Standards, as in effect from time to time.
1.52. Indemnification Claim Notice has the meaning set forth in Section 11.3.
1.53. Indemnified Party has the meaning set forth in Section 11.3.
1.54. Indemnifying Party has the meaning set forth in Section 11.3.
1.55. Indirect Taxes means value added taxes, sales taxes, consumption taxes and other similar taxes.
1.56. Initiation means dosing of the first human subject of a Clinical Trial.
1.57. Infringement has the meaning set forth in Section 8.6.1.
1.58. Invented means the act of invention by inventors, as determined in accordance with the patent laws of the United States of America.
1.59. Joint Know-How means any Collaboration Know-How that is conceived or developed or, in the case of patentable Know-How, Invented jointly by an employee of Hutchison or its Affiliates (or a Third Party acting on any of their behalf) and an employee of AstraZeneca or its Affiliates (or a Third Party acting on any of their behalf).
1.60. Joint Patent Right means any Patent Right that claims Joint Know-How and is Invented by one or more employees or agents of Hutchison or its Affiliates (or a Third Party acting on any of their behalf) together with one or more employees or agents of AstraZeneca or its Affiliates (or a Third Party acting on any of their behalf).
1.61. Joint Technology means Joint Know-How, Joint Patent Rights, and all other intellectual property rights therein.
1.62. JSC has the meaning set forth in Section 3.1.
1.63. Know-How means all inventions, discoveries, data, information (including scientific, technical or regulatory information), processes, methods, techniques, materials, technology, results, analyses, laboratory data, data arising from Clinical Trials and Post-Approval Clinical Trials, and other know-how, whether or not patentable, including pharmacology, toxicology, drug stability, manufacturing and formulation data, methodologies and techniques, clinical and non-clinical safety and efficacy studies, marketing studies, absorption, distribution, metabolism and excretion studies.
1.64. Liability has the meaning set forth in Section 11.1.
1.65. Litigation Conditions has the meaning set forth in Section 11.3.
1.66. Major Market Country means each of [**].
1.67. Manufacture, Manufactured or Manufacturing means all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and storage of Collaboration Products to be Developed or Commercialized under this Agreement, including API Manufacturing, whether such activities are conducted by a Party, its Affiliates or a Third Party contractor of such Party. When used as a verb, Manufacture means to engage in Manufacturing.
1.68. Net Sales means, on a country-by-country and Collaboration Product-by-Collaboration Product basis, with respect to any period for each country, the gross amounts (the Gross Sales ) invoiced by a Party, its Sublicensees or its Affiliates, as applicable, to unrelated Third Parties for sales of a Collaboration Product in the Field in such country, less the following deductions to the extent included in the gross invoiced sales price for such Collaboration Product or otherwise directly paid or incurred by a Party, its Sublicensees or its Affiliates with respect to the sale of such Collaboration Product in such country: [**].
Net Sales will be determined in accordance with GAAP or IFRS, as applicable. For purposes of determining Net Sales, the Collaboration Products shall be deemed to be sold when invoiced and a sale shall not include, and no royalties shall be payable on, transfers by AstraZeneca, its Affiliates or Sublicencees of free samples of Collaboration Products or clinical trial materials containing a Collaboration Compound or Collaboration Product, or transfers of Collaboration Product to patients under AstraZenecas Patient Assistance Program in the United States or any similar programs in other countries, or other transfers or dispositions for charitable, promotional, pre-clinical, clinical, manufacturing, testing or qualification, regulatory or governmental purposes.
In the event a Collaboration Product is sold as a Combination Collaboration Product, Net Sales of the Collaboration Product will be calculated, for each applicable Calendar Quarter, as follows:
(i) If the Combination Collaboration Product, the Single Active Collaboration Product and a product containing solely the other therapeutically or prophylactically active ingredient(s) are sold separately, Net Sales of the Single Active Collaboration Product portion of Combination Collaboration Products will be calculated by multiplying the total Net Sales of the Combination Collaboration Product by the fraction A/(A+B), where A is the average gross selling price in the applicable country of the Single Active Collaboration Product sold separately in the same formulation and dosage, and B is the sum of the average gross selling prices in the applicable country of all products containing solely such other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product sold separately in the same formulation and dosage.
(ii) If the Combination Collaboration Product and the Single Active Collaboration Product are sold separately, but the average gross selling price of a product containing solely the other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product cannot be determined, Net
Sales of the Combination Collaboration Product shall be equal to the Net Sales of the Combination Collaboration Product multiplied by the fraction A/C wherein A is the average gross selling price of the Single Active Collaboration Product, and C is the average gross selling price of the Combination Collaboration Product.
(iii) If the Combination Collaboration Product and the product containing solely other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product are sold separately, but the average gross selling price of the Single Active Collaboration Product cannot be determined, Net Sales of the Combination Collaboration Product shall be equal to the Net Sales of the Combination Collaboration Product multiplied by the following formula: one (1) minus B/C wherein B is the average gross selling price of the product containing solely the other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product, and C is the average gross selling price of the Combination Collaboration Product.
(iv) If the Combination Collaboration Product and the product containing solely other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product are sold separately, but the average gross selling price of neither the Single Active Collaboration Product nor the product containing solely the other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product can be determined, Net Sales of the Combination Collaboration Product shall be equal to Net Sales of the Combination Collaboration Product multiplied by a mutually agreed percentage that is reasonably reflective of the relative value of each active ingredient in the Combination Collaboration Product.
The average gross selling price for the Single Active Collaboration Product and such product containing solely other therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product shall be calculated for each Calendar Quarter by dividing the sales amount by the units sold of such Single Active Collaboration Product or such other product containing solely therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product, as published by IMS or another mutually agreed independent source.
In the absence of appropriate IMS or other mutually agreed upon data, in the initial Calendar Year during which a Combination Collaboration Product is sold, a forecasted average gross selling price shall be used for the Collaboration Compound, other product containing solely therapeutically or prophylactically active ingredient(s) in the Combination Collaboration Product,or Combination Collaboration Product, as applicable. Any over- or under- payment due to a
difference between forecasted and actual average gross selling prices shall be paid or credited in the second royalty payment of the following Calendar Year. In the following Calendar Year the average gross selling price of the previous Calendar Year shall apply.
1.69. New Drug Application or NDA means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the U.S.
1.70. New Third Party License has the meaning set forth in 5.6.1.
1.71. NSCLC means non-small cell lung cancer.
1.72. Patent Right means any and all (a) patent applications filed under Applicable Law in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (b) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof and (c) any other form of government-issued right substantially similar to any of the foregoing.
1.73. Person means 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 or department or agency of a government.
1.74. Pharmacovigilance Agreement has the meaning set forth in Section 4.3.5.
1.75. Phase I Clinical Trial means a Clinical Trial defined in 21 C.F.R. 312.21(a), as may be amended from time to time, or any equivalent thereto in any other jurisdiction.
1.76. Phase II Clinical Trial means a Clinical Trial defined in 21 C.F.R. 312.21(b), as may be amended from time to time, or any equivalent thereto in any other jurisdiction.
1.77. Phase III Clinical Trial means a Clinical Trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any equivalent thereto in any jurisdiction.
1.78. Phase IV Clinical Trial means a Clinical Trial conducted after a Collaboration Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Collaboration Product.
1.79. Post-Approval Clinical Trial means any Clinical Trial for use of a
Collaboration Product in an indication, other than a Phase III Clinical Trial or Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication.
1.80. Primary Indication means [**], as more particularly defined in the Development Plan
1.81. Receiving Party has the meaning set forth in Section 6.1.1.
1.82. Recipients has the meaning set forth in Section 6.1.1.
1.83. Regulatory Approval means, with respect to a product, the approval and authorization of a Regulatory Authority in a country necessary to manufacture, distribute, sell or market such product in such country.
1.84. Regulatory Authority means any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in each country of the Territory involved in the granting of Regulatory Approvals.
1.85. Regulatory Exclusivity means any rights or protections which are recognized, afforded or granted by any Regulatory Authority in any country or region in association with the Regulatory Approval of a Collaboration Product, providing such Collaboration Product a period of marketing exclusivity during which a Regulatory Authority that recognizes, affords or grants such marketing exclusivity shall refrain from either reviewing or approving a marketing authorization application or similar Regulatory Submission submitted by a Third Party seeking to market a generic product. Regulatory Exclusivity shall include rights conferred in the United States pursuant to the Hatch-Waxman Amendments to the FD&C Act, the Orphan Drug Act or the Best Pharmaceuticals for Children Act or in the European Union pursuant to Section 10.1(a)(iii) of Directive 2001/EC/83.
1.86. Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Collaboration Product in the Field in a particular country, whether obtained before or after a Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Collaboration Product in a particular country.
1.87. Regulatory Submission Party means, with respect to a country or territory, the Party responsible for regulatory matters in such country or territory pursuant to Section 4.5.1.
1.88. Right of Reference means a Right of Reference, as that term is defined in 21 C.F.R. § 314.3(b) or any analogous Applicable Law recognized outside of the United States.
1.89. Royalty Period means, on a country-by-country and Collaboration Product-by-Collaboration Product basis, the period of time [**].
1.90. ROW Territory means all countries of the world other than China.
1.91. Sales Milestone has the meaning set forth in Section 5.2.2.
1.92. Secondary Indication means [**], as more particularly defined in the Development Plan.
1.93. Single Active Collaboration Product means a Collaboration Product that contains a Collaboration Compound as the sole active ingredient.
1.94. Sublicensee means an Affiliate or Third Party that is granted a license, sublicense, covenant not to sue or other grant of rights under the licenses granted pursuant to Section 2 of this Agreement. Sublicense means an agreement or arrangement pursuant to which such a sublicense has been granted to a Sublicensee.
1.95. Sublicensee Material Breach has the meaning set forth in Section 2.5.3.
1.96. Sublicensor means a Party that has granted a Sublicense under rights granted to such Party under this Agreement.
1.97. Sued Party has the meaning set forth in Section 8.7.2.
1.98. Technology means Know-How and Patent Rights.
1.99. Term has the meaning set forth in Section 10.1.
1.100. Territory means China and the ROW Territory.
1.101. Third Party means any Person other than Hutchison and its Affiliates and AstraZeneca and its Affiliates.
1.102. Trademark means any trademark used by the Parties in connection with a Collaboration Product, other than the Parties trade names and trademarks used by the Parties to identify their companies generally.
1.103. Translational Research Activities means activities relating to the Development of Diagnostic Products.
1.104. Valid Claim means any claim of (a) any issued and unexpired Patent Right that claims a Collaboration Compound that has not been (i) revoked or held unenforceable, unpatentable or invalid by a Government Authority of competent jurisdiction in a decision that is not appealable or that has not been appealed within the time allowed for appeal or (ii) abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or otherwise, or (b) any patent application that claims a Collaboration Compound that has not been (i) cancelled, withdrawn or abandoned without being refiled in another application in the applicable jurisdiction or (ii) finally rejected by an administrative agency or Government Authority of competent jurisdiction in a decision that is not appealable or that has not been appealed within the time allowed for appeal, provided that, on a country-by-country basis, a patent application pending for more than [**] from the priority date of such application shall not be considered to have any Valid Claim for purposes of this Agreement from and after such [**] date unless and until a patent with respect to such application issues.
1.105. Withholding Taxes has the meaning set forth in Section 5.8.2.
2. SCOPE OF COLLABORATION AND GRANT OF LICENSES.
2.1. Scope of Collaboration. The Parties wish to enter into this Agreement (a) to co-Develop, Manufacture and Commercialize the Collaboration Compound and Collaboration Products in the Field in the Territory and (b) to develop, manufacture and commercialize Agreement Compounds, on an exclusive basis, in accordance with Section 6.3 , in each case ((a) and (b)), in accordance with the terms and conditions of this Agreement.
2.2. License to AstraZeneca. Subject to the terms and conditions of this Agreement, Hutchison hereby grants to AstraZeneca, effective on the Effective Date, (a) a royalty-bearing, co-exclusive license, with the right to sublicense as set forth in Section 2.5, under the Hutchison Technology and Hutchisons interest in the Joint Technology, to Develop the Collaboration Compound and Collaboration Products in the Field in the Territory in accordance with the terms of this Agreement and (b) a royalty-bearing, exclusive (even as to Hutchison) license, with the right to sublicense as set forth in Section 2.5, under the Hutchison Technology and Hutchisons interest in the Joint Technology, to Manufacture and Commercialize the Collaboration Products in the Field in the Territory.
2.3. License to Hutchison. Subject to the terms and conditions of this Agreement, AstraZeneca hereby grants to Hutchison a royalty-free, co-exclusive license, with the right to sublicense as set forth in Section 2.5, under the AstraZeneca Technology and AstraZenecas interest in the Joint Technology (a) to the extent necessary for Hutchison to exercise its rights and perform its obligations under this Agreement and (b) to Develop the Collaboration Compound and Collaboration Products in the Field in the Territory in accordance with the terms of this Agreement.
2.4. Joint Technology. Subject to the terms and conditions of this Agreement (including Sections 2.2 and 2.3), each Party hereby grants the other Party a worldwide, irrevocable, non-exclusive, perpetual, royalty-free, fully paid up, freely sublicensable right and license to exploit the Joint Technology in any manner without compensating or accounting to the other Party.
2.5. Sublicensing.
2.5.1. AstraZeneca Right to Sublicense .
(a) AstraZeneca shall have the right to grant Sublicenses under the rights granted to AstraZeneca in Section 2.2 to its Affiliates and to Third Parties for the Development, Manufacture and Commercialization of Collaboration Compounds and Collaboration Products in the Field, provided that AstraZeneca shall (i) remain responsible for the performance of its Sublicensees under this Agreement, including for all payments due hereunder; and (b) cause its Sublicensees to comply with the terms of this Agreement.
(b) Each Sublicense (i) shall be subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (ii) shall not diminish, reduce or eliminate any of AstraZenecas obligations under this Agreement; (iii) shall require the Sublicensee(s) to comply with all applicable terms of this Agreement (except for the payment obligations, for which AstraZeneca shall remain financially responsible); (iv) shall require that any Sublicensee grant to AstraZeneca a Right of Reference to the same extent of the Right of Reference granted to AstraZeneca pursuant to Section 2.6.1; and (v) shall prohibit further sublicensing except on terms consistent with this Section 2.5.1. AstraZeneca shall provide Hutchison with a complete copy of each Sublicense granted to a Third Party within thirty (30) days after execution thereof; provided , however , that AstraZeneca may redact any Confidential Information from such Sublicense to the extent that such redactions do not reasonably impair Hutchisons ability to ensure compliance with this Agreement.
2.5.2. Hutchison Right to Sublicense .
(a) Hutchison shall have the right to grant Sublicenses under the rights granted to Hutchison in Section 2.3 to its Affiliates and to Third Parties for the Development of the Collaboration Compound and Collaboration Products in the Field in any country; provided that Hutchison shall (i) shall remain responsible for the performance of its Sublicensees under this Agreement, including for all payments due hereunder; and (ii) cause its Sublicensees to comply with the terms of this Agreement.
(b) Each Sublicense (i) shall be subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (ii) shall not diminish, reduce or eliminate any of Hutchisons obligations under this Agreement; (iii) shall require the Sublicensee(s) to comply with all applicable terms of this Agreement;
(iv) shall require that any Sublicensee grant to Hutchison a Right of Reference to the same extent of the Right of Reference granted to Hutchison pursuant to Section 2.6.2; and (v) shall prohibit further sublicensing except on terms consistent with this Section 2.5.2. Hutchison shall provide AstraZeneca with a complete copy of each Sublicense within thirty (30) days after execution thereof; provided , however , that Hutchison may redact any Confidential Information from such Sublicense to the extent that such redactions do not reasonably impair AstraZenecas ability to ensure compliance with this Agreement.
2.5.3. Breach of Sublicense . In the event of an uncured material breach by any Sublicensee under a Sublicense that would constitute a material breach of the Sublicensors obligations under this Agreement (a Sublicensee Material Breach ), the Sublicensor shall provide prompt written notice of such Sublicensee Material Breach to the other Party and shall use Commercially Reasonable Efforts to remedy such Sublicensee Material Breach; provided , however , that if the Sublicensor is unable to cure such Sublicensee Material Breach in accordance with Section 10.3.1 of this Agreement, such Sublicensee Material Breach shall be deemed to be an uncured material breach by the Sublicensor under this Agreement.
2.5.4. Effect of Termination on Sublicenses . In the event of a termination of this Agreement pursuant to Section 10 while a Sublicense granted under Section 2.5 is in effect, the terms of this Section 2.5.4 shall apply, provided that the Sublicensee is not in default under the applicable Sublicense and such Sublicensee certifies in writing to the non-terminating Party that (x) it is not in default under the applicable Sublicense, (y) such Sublicensee agrees to be bound by the terms of this Agreement applicable to the Sublicensor and (y) such Sublicensee agrees to the following additional terms:
(a) All of the Sublicensees obligations under the Sublicense shall remain in effect as obligations to the non-terminating Party and shall be enforceable solely by such Party as a third party beneficiary. The Sublicensees rights under the Sublicense that do not exceed, and are not inconsistent with, the Sublicensors rights under this Agreement, whether in scope, duration, nature or otherwise, shall survive termination of the Sublicense.
(b) All of the Sublicensors rights under the Sublicense shall remain in effect, may be exercised solely by the non-terminating Party as a third party beneficiary and shall inure to the exclusive benefit of the non-terminating Party. All obligations of the Sublicensor under the Sublicense that exceed or are not consistent with the Sublicensors obligations under this Agreement, whether in scope, duration, or otherwise, shall terminate.
2.6. Right of Reference.
2.6.1. AstraZeneca Right of Reference . Hutchison hereby grants to AstraZeneca and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by Hutchison and its Affiliates relating to a Collaboration Compound or Collaboration Products to the extent necessary to obtain Regulatory Approval of any Collaboration Product in the Field in any country of the ROW Territory, and
Hutchison shall provide a signed statement to this effect, if requested by AstraZeneca, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Applicable Law recognized outside of the United States).
2.6.2. Hutchison Right of Reference . AstraZeneca hereby grants to Hutchison and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by AstraZeneca and its Affiliates relating to Collaboration Products to the extent necessary or useful to Develop or Manufacture Collaboration Compounds or Collaboration Products in the Field in China, and AstraZeneca shall provide a signed statement to this effect, if requested by Hutchison, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Applicable Law recognized outside of the United States).
2.7. Delivery of Hutchison Know-How . At no cost to AstraZeneca, within [**] days after the Effective Date, Hutchison shall transfer to AstraZeneca true and complete copies of all Hutchison Know-How (in electronic or hard copy format) with, where applicable (and within reason), a translation into English. Thereafter during the Term, from time to time and otherwise upon AstraZenecas request, Hutchison shall provide AstraZeneca with true and complete copies of updates to the Hutchison Know-How (in electronic or hard copy format), together with all information or assistance reasonably requested by AstraZeneca with respect to understanding and using such Hutchison Know-How.
2.8. Delivery of AstraZeneca Know-How . At no cost to Hutchison, for so long as the Development Plan remains in effect, from time to time and otherwise upon Hutchisons request, AstraZeneca shall transfer to Hutchison true and complete copies of all AstraZeneca Know-How (in electronic or hard copy format), together with all information or assistance reasonably requested by Hutchison with respect to understanding and using such AstraZeneca Know-How.
2.9. No Other Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights shall be deemed granted to either Party by implication, estoppel or otherwise, with respect to any intellectual property rights. All rights not expressly granted by either Party to the other hereunder are reserved.
3. DECISION MAKING AND DISPUTE RESOLUTION.
3.1. Joint Steering Committee. Within thirty (30) days of the Effective Date, the Parties shall establish a joint steering committee (the JSC ) that will be responsible for overseeing the Development and Commercialization of Collaboration Products in the Field, and will serve as a forum for (a) exchanging data, information and Development strategy regarding the Collaboration Products and (b) keeping Hutchison apprised of all Commercialization activities with respect to the Collaboration Products.
3.1.1. Membership . The JSC will consist of three (3) senior representatives from each Party. AstraZeneca will designate the chairperson of the JSC. The chairperson will be responsible for calling meetings and setting the agenda (which shall include a list of all participants expected at a meeting) and circulating such agenda at least five (5) days prior to each meeting and
distributing minutes of the meetings within thirty (30) days following such meeting, but will not otherwise have any greater power or authority than any other member of the JSC. JSC members may be replaced by the Party with authority to designate such member but shall at all times have such expertise as appropriate to the activities of the JSC from time to time, and the JSC shall invite personnel of the Parties having non-clinical safety and animal pharmacology, pharmaceutical development, clinical, biostatistical, regulatory affairs, pharmacovigilance, formulation, manufacturing, commercial, marketing and other expertise to participate in discussions of the JSC from time to time as appropriate to assist in the activities of the JSC. The JSC may appoint subcommittees as desired.
3.1.2. Responsibilities . The JSC may discharge its responsibilities through one or more subcommittees. The JSCs responsibilities will include, without limitation, the following:
(a) overseeing implementation of the Development Plan;
(b) reviewing and evaluating progress under the Development Plan (including compliance with the Development Budget contained therein and payment arrangements) on a quarterly basis and advising the Parties as to any necessary amendments thereto;
(c) allocating and assigning Development activities in the Development Plan between the Parties, consistent with the terms of this Agreement;
(d) approving (or establishing procedures to approve) protocols for pre-clinical studies and Clinical Trials for Development of Collaboration Products;
(e) making modifications to and performing quarterly monitoring of progress of pre-clinical studies and Clinical Trials and proposing additional studies for Collaboration Products;
(f) reviewing and approving any proposed modifications to the Development Plan, including advising the Parties as to whether a Back-Up Compound should be developed in lieu of a Collaboration Compound;
(g) coordinating the Manufacture of global supplies of a Collaboration Compound and Collaboration Product for (i) Clinical Trials and (ii) Commercialization;
(h) reviewing and commenting on Regulatory Submissions relating to Collaboration Products;
(i) facilitating the exchange of all data, information, material or results relating to Development of Collaboration Products;
(j) establishing procedures regarding the collection, sharing and reporting of Adverse Event information related to Collaboration Products consistent with the Pharmacovigilance Agreement to be entered into in accordance
with Section 4.3.5;
(k) facilitating the transfer of Know-How pursuant to this Agreement;
(l) developing a strategy for performing Translational Research Activities and Developing a Diagnostic Product, as necessary, under the Development Plan and overseeing implementation of any such strategy;
(m) establishing and overseeing implementation of the Commercialization Plan;
(n) performing such other activities as are contemplated under this Agreement and that the Parties mutually agree shall be the responsibility of the Joint Steering Committee.
Notwithstanding the foregoing, in no event shall the JSC or any subcommittee of the JSC have the authority to (i) reduce or expand the obligations of the Parties under this Agreement; (ii) determine that a breach has occurred under this Agreement; (iii) waive a Partys rights or obligations under this Agreement; or (iv) make any decision that is specified elsewhere in this Agreement as being made by one or both Parties.
3.1.3. Meetings . During the period before First Commercial Sale, the JSC will meet at such frequency as shall be established by the Parties (but, unless otherwise agreed, not less frequently than four (4) times per year). Meetings of the JSC shall alternate between the offices of the Parties, unless otherwise agreed upon by the members of the JSC, or may be held telephonically or by video conference. Meetings of the JSC shall be effective only if at least one representative of each Party is in attendance or participating in the meeting. Members of the JSC shall have the right to participate in and vote at meetings by telephone. Each Party shall be responsible for expenses incurred by its employees and its members of the JSC in attending or otherwise participating in JSC meetings. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JSC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative.
3.1.4. Minutes and Agendas . The minutes of each JSC meeting shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by the JSC. Minutes of each JSC meeting shall be prepared in English, approved or disapproved, and revised as necessary, at the next meeting.
3.2. Other Committees. The JSC may establish subcommittees as the Parties mutually deem appropriate.
3.2.1. Joint Development Committee . Promptly after the Effective Date, the JSC shall establish a joint development committee ( JDC ). The JDC shall have primary responsibility for the matters set forth in Section 3.1.2(a) - 3.1.2(f) and 3.1.2(h) - 3.1.2(j), together with such other matters as are delegated to the JDC by the JSC.
3.2.2. Joint Commercial Committee Prior to Commercialization of any
Collaboration Product, the JSC shall establish a joint commercial committee ( JCC ). The JCC shall have primary responsibility for the matters set forth in Section 3.1.2(m), together with such other matters as are delegated to the JCC by the JSC.
3.2.3. Joint Diagnostic Development Committee . Promptly after the Effective Date, the JSC shall establish a joint diagnostic development committee ( JDDC ). The JDDC shall have primary responsibility for the matters set forth in Section 3.1.2(l).
3.2.4. Joint Manufacturing Committee . Promptly after the Effective Date, the JSC shall establish a joint manufacturing committee ( JMC ). The JMC shall have the primary responsibility for the matters set forth in 3.1.2(g).
3.2.5. Joint Intellectual Property Committee . Promptly after the Effective Date, the JSC shall establish a Joint IP Committee ( JIPC ). The JIPC shall have primary responsibility for establishing a strategy for the prosecution, maintenance and enforcement of intellectual property rights relating to the Collaboration Product, together with such other matters as are delegated to the JIPC by the JSC. The JIPC shall have primary responsibility for the matters set forth in Section 3.1.2(k), together with such other matters as are delegated to the JIPC by the JSC.
3.3. Elevation and Dispute Resolution. [**].
3.3.1. [**].
3.3.2. [**]
(a) [**]
(b) [**]
(c) [**]
(d) [**]
(e) [**]
3.3.3. [**].
4. DEVELOPMENT, REGULATORY, COMMERCIALIZATION.
4.1. Development of Collaboration Product and Diagnostic Product.
4.1.1. Development Plan . The initial Development Plan for the Collaboration Product in the Field is set forth in Schedule 1.32 . The JDC will direct, coordinate and manage the Development of Collaboration Products in the Field in accordance with the Development Plan. During the Term, the JDC will review the Development Plan (including the Development Budget) on an ongoing basis, but no less frequently than once per year during the period preceding First Commercial Sale and will amend as necessary, provided that the JDC will not assign any Development activities to a Party, or allocate any Development Costs to a Party beyond those set forth in the initial Development Plan attached hereto without the other Partys prior written consent.
4.1.2. Development Activities . Each Party shall use Commercially Reasonable Efforts to implement and conduct the Development activities assigned to it under the Development Plan, in accordance with the Development Budget and the timelines set forth in the Development Plan, and to cooperate with and provide reasonable support to the other Party in such other Partys conduct of activities under the Development Plan. Each Party will undertake its respective Development activities in accordance with GLP, GCP, GMP, as appropriate, and with all Applicable Laws. Except for the specific responsibilities allocated to Hutchison as set forth in the Development Plan with respect to Development activities intended to support obtaining Regulatory Approval for Collaboration Products or Diagnostic Products in China, AstraZeneca will be responsible for performing all Development activities for the purpose of obtaining Regulatory Approval for Collaboration Product and Diagnostic Products in the ROW Territory. The Parties shall share costs and expenses under this Section 4.1.2 in accordance with the allocations set forth in Section 5.7. All Clinical Trials initiated
after the Effective Date and performed by a Third Party will be conducted by agents both Parties agree have sufficient capability to ensure all Clinical Trials performed by such Third Party are conducted and reported, and can be audited to show they have been conducted and reported, to comply with standards of GCP acceptable to Regulatory Authorities globally.
4.1.3. Reports of Development Activities . Each Party shall report on Development activities undertaken by such Party in accordance with Development Plan by providing a reasonably detailed summary of all results, data and material inventions, if any, obtained from such activities, together with a summary of the Development activities that such Party intends to undertake during the next twelve (12) months with respect to Development of a Collaboration Compound and Collaboration Product. Such reports shall be provided in English by each Party to the other at least [**] days prior to each meeting of the JDC, [**]. In addition, each Party shall, at its own expense, make appropriate scientific and regulatory personnel available to the other Party, either by telephone or in person as the Parties may mutually agree, as reasonably required to keep the other Party informed of Development activities.
4.1.4. Development Diligence Obligations . AstraZeneca shall use Commercially Reasonable Efforts to apply for and obtain Regulatory Approval of the Collaboration Product in the ROW Territory, and Hutchison shall use Commercially Reasonable Efforts to apply for and obtain Regulatory Approval of the Collaboration Product in China, in each case, as soon as reasonably practicable. AstraZeneca shall use Commercially Reasonable Efforts to Develop or procure the Development of any Diagnostic Products reasonably necessary to Commercialize the Collaboration Products and to apply for and obtain Regulatory Approval of such Diagnostic Products in the Territory as soon as reasonably practicable.
4.2. Failure of Collaboration Product . In the event [**], such Party shall have the right to request a meeting of the JSC, which shall discuss in good faith the Back-Up Compounds then available. In such case, the following provisions shall apply.
4.2.1. Nomination of New Collaboration Compound . In the event [**], the JSC (advised by the JDC, as appropriate) shall promptly nominate a Back-Up Compound to replace the Collaboration Compounds (such Back-Up Compound, a New Collaboration Compound ), and the Parties shall promptly meet to negotiate in good faith a definitive agreement (or amendment to this Agreement, if appropriate) that sets forth each Partys rights and obligations with respect to such New Collaboration Compound. Until execution of any such definitive agreement (or amendment), the terms and conditions of this Agreement applicable to the Collaboration Compound shall continue in full force and effect.
4.2.2. Failure to Agree on New Collaboration Compound . In the event the Parties do not mutually agree as to whether the Parties should continue activities under the Development Plan with respect to the Collaboration Compound, either Party shall have the right to terminate this Agreement under Section 10.2, and the effects of termination set forth in Section
10.4.1 shall apply.
4.3. Regulatory Matters .
4.3.1. Responsibility for Regulatory Interactions .
(a) Subject to the terms and conditions of this Agreement, AstraZeneca shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in all countries and territories other than China, and Hutchison shall be responsible for all regulatory matters relating to Collaboration Products and Diagnostic Products in China. Hutchison shall be the Regulatory Submission Party for China, and AstraZeneca shall be the Regulatory Submission Party for the ROW Territory. The costs and expenses associated with the Parties activities under this Section 4.3.1 shall be allocated as set forth in Section 5.7. With regard to the Development of a Diagnostic Product, it is the Parties current intention that such Development will be undertaken by a Third Party under contract to the Parties and such Third Party will be responsible for the regulatory matters relating to the Diagnostic Products.
(b) Without limiting the foregoing, subject to the terms and conditions of this Agreement, the Regulatory Submission Party shall have sole authority in the applicable country or territory with respect to (i) obtaining Regulatory Approvals for Collaboration Products and subsequently maintaining such Regulatory Approvals, (ii) communicating with Regulatory Authorities about Collaboration Products and (iii) preparing and submitting supplements, communications, annual reports, Adverse Event reports, manufacturing changes, supplier designations and other related regulatory filings and Regulatory Submissions.
(c) Each Party shall keep the JSC reasonably informed regarding the status and progress of its activities conducted pursuant to this Section 4.3.1, including providing the JSC with advance notice of all meetings scheduled with a Regulatory Authority (including notice promptly after a request for a meeting received from a Regulatory Authority) involving a Regulatory Submission, providing the JSC with a copy of all substantive written correspondence from a Regulatory Authority involving a Regulatory Submission, notifying the JSC of all oral substantive correspondence from a Regulatory Authority involving a Regulatory Submission, and promptly providing the JSC with each Regulatory Submission submitted to a Regulatory Authority.
4.3.2. Regulatory Cooperation . At no cost to the other Party, other than reimbursement of a Partys reasonable out-of-pocket costs and expenses, the Regulatory Submission Party shall provide the other Party with reasonable access to and copies of any documents, correspondence or other materials Controlled by the Regulatory Submission Party that are useful for Regulatory Submissions for Collaboration Products to be made by the other Party pursuant to Section 4.3.1, and will otherwise cooperate with the other Party with respect to such Partys efforts to obtain and maintain Regulatory Approvals for Collaboration Products in the Field
pursuant to Section 4.3.1.
4.3.3. Regulatory Meetings . The Regulatory Submission Party shall provide the other Party with notice of all meetings, conferences and discussions (including without limitation, advisory committee meetings or any other meeting of experts convened by any Regulatory Authority concerning any topic relevant to the Collaboration Product) promptly after the scheduling of such meeting, conference or discussion. The Party that does not, at the time of such meeting, own the Regulatory Submission for the Collaboration Product that is the subject of such meeting shall be entitled to have one (1) or more representatives, as appropriate under the circumstance and at its sole cost, present at all such meetings. Hutchison and AstraZeneca, through the JDC, shall use all reasonable efforts to agree in advance on the scheduling of such meetings, conferences and discussions and on the objectives to be accomplished at such meetings, conferences and discussions and the agenda for the meetings, conferences and discussions with the Regulatory Authority. Each Party shall provide to the other Party, as soon as reasonably practicable but in no event more than two (2) Business Days after its receipt, copies of any material documents or other material correspondence received from a Regulatory Authority in China, United States, European Union or Japan pertaining to the Collaboration Compound or Collaboration Product.
4.3.4. Regulatory Audits . If a Regulatory Authority desires to conduct an inspection or audit of a Partys facility, or a facility under contract with a Party, with regard to a Collaboration Product, then such Party shall promptly notify the other Party and permit and cooperate with such inspection and audit. Following receipt of the inspection or audit observations of such Regulatory Authority (a copy of which the audited Party will immediately provide to the other Party), the audited Party shall prepare the response to any such observations and shall provide a copy of such response to the other Party.
4.3.5. Adverse Events . Within ninety (90) days after the Effective Date, the Parties will enter into a pharmacovigilance agreement, which upon such execution will be attached as an exhibit hereto and hereby incorporated into this Agreement by reference (the Pharmacovigilance Agreement ). The Parties shall comply with the provisions of such agreement. AstraZeneca shall maintain and will be the recognized holder of a global safety database for Adverse Event reports related to the Collaboration Product. Unless otherwise agreed to by the Parties, AstraZeneca will respond to all safety inquiries regarding Collaboration Products in the Field in the Territory.
4.4. Manufacture.
4.4.1. Selection of a Manufacturer for Clinical Supply . Promptly after the Effective Date, the JSC shall select one (1) or more manufacturers to Manufacture and supply Collaboration Compound and Collaboration Product for all Development activities under the Development Plan in the Territory (the Designated Manufacturer ). In the event that the JSC cannot unanimously agree on the selection of a single Designated Manufacturer for the Territory, AstraZeneca shall have the right to select a Designated Manufacturer to Manufacture the Collaboration Compound or Collaboration Product for use in the Territory, recognizing the needs for selecting a Designated Manufacturer to Manufacture in China for the China Development Activities in order to support the rapid Regulatory Approval of the Collaboration Product in China.
4.4.2. Designated Manufacturer Agreements for Clinical Supply . Subject to oversight by the JSC, the Parties shall be jointly responsible for procuring sufficient quantities of Collaboration Compound and Collaboration Product as are necessary for the Parties to perform their respective obligations under the Development Plan. Unless the Parties agree to a single Designated Manufacturer under Section 4.4.1, Hutchison shall negotiate in good faith and enter into an agreement with a Designated Manufacturer for the Manufacture and supply of such quantities of Collaboration Compound and Collaboration Product as are necessary for Hutchison to perform its obligations under the Development Plan (i.e., with respect to China). In the case where such agreement refers to the future commercial terms of supply of a Collaboration Compound or Collaboration Product then the prior approval of AstraZeneca to such terms shall be sought. Unless the Parties agree to a single Designated Manufacturer under Section 4.4.1, AstraZeneca shall negotiate in good faith and enter into an agreement with a Designated Manufacturer for the Manufacture and supply of such quantities of Collaboration Compound and Collaboration Product as are necessary for AstraZeneca to perform its obligations under the Development Plan (i.e., with respect to the ROW Territory). Each Party shall promptly provide to the other Party a copy of its agreement with the Designated Manufacturer promptly after execution thereof. [**]. The Parties shall share costs and expenses of procuring supply from a Designated Manufacturer under this Section 4.4.2 in accordance with the allocations set forth in Section 5.7.
4.4.3. Commercial Supply of Collaboration Compound and Collaboration Product. AstraZeneca shall be solely responsible, at its sole expense, for Manufacturing or having Manufactured commercial quantities of Collaboration Compound and Collaboration Product for sale throughout the Territory.
4.5. Commercialization.
4.5.1. Commercialization Activities . As of the Effective Date, the Parties contemplate that (i) AstraZeneca shall be responsible for the Commercialization of the Collaboration Product in the Territory and (ii) the Parties may negotiate in good faith to co-Commercialize (but not co-promote) the Collaboration Product in China. Any such co-Commercialization shall be subject to a separate written agreement of the Parties.
4.5.2. Reports of Commercialization Activities . AstraZeneca shall provide Hutchison with quarterly reports of the activities it has undertaken with regard to Commercializing Collaboration Products in the Field in all countries and territories, including AstraZenecas efforts to achieve the diligence obligations set forth in Section 4.6.4. In addition, AstraZeneca shall meet with Hutchison, at Hutchisons request, no more than two (2) times per year to report on the activities it has undertaken with regard to Commercializing Collaboration Products in the Field and to provide a forum for Hutchison to provide feedback regarding such Commercialization activities, which feedback shall be reasonably considered by AstraZeneca in developing its future Commercialization strategy for a Collaboration Compound and Collaboration Products.
4.5.3. Commercialization Diligence Obligations . AstraZeneca shall use
Commercially Reasonable Efforts to Commercialize Collaboration Products in the Field in the Territory. AstraZeneca shall use Commercially Reasonable Efforts to identify and procure the Commercialization of any Diagnostic Product reasonably necessary to Commercialize the Collaboration Products in the Territory. Upon the grant of a Regulatory Approval for a Collaboration Product in a country, AstraZeneca shall use Commercially Reasonable Efforts to market Collaboration Products in such country. AstraZeneca shall not, and shall ensure that its Affiliates and Sublicensees do not, seek Regulatory Approval for or Commercialize a Combination Collaboration Product in any country or territory prior to obtaining Regulatory Approval for and Commercializing in such country a Collaboration Product that is not a Combination Collaboration Product.
4.6. Phase IV and Publication Strategy.
4.6.1. Conduct of Phase IV Clinical Trials . Neither Party shall undertake, or permit its Affiliates or Sublicensees to undertake, any pre-clinical study or Clinical Trial of any Collaboration Product, including Phase IV Clinical Trials, but excluding any studies required for Regulatory Approval or otherwise imposed by a Regulatory Authority and authorized under the Development Plan, without approval of such studies by the JSC.
4.6.2. Publication Strategy . The Parties shall coordinate worldwide publication strategy involving Collaboration Products and activities involving Collaboration Products related to scientific conferences through the JSC. Review and approval of individual manuscripts shall be delegated to appropriate working groups of the Parties. Each Party shall be afforded the opportunity to review and approve any scientific paper or presentation with respect to any Collaboration Product proposed for publication, presentation or distribution by the other Party or its Affiliates or Sublicensees and shall have no more than [**] to complete such review and approval (or such shorter period as may reasonably be required by applicable publication deadlines promptly communicated to such Party). The Party proposing a publication or presentation shall (a) not unreasonably reject comments furnished by the other Party, (b) comply with the other Partys request to delete references to its Confidential Information in any such publication or presentation and (c) delay publication for such reasonable period requested by the other Party to permit the filing of patent applications concerning any AstraZeneca Technology, Hutchison Technology or Joint Technology disclosed in material proposed for such publication or presentation. In no event will Confidential Information of a Party be published without the consent of such Party.
4.6.3. Permitted Publications . Notwithstanding anything to the contrary in this Agreement, both Parties and their respective Affiliates shall be entitled to publicly disclose significant Collaboration Product achievements of the type and by the means customary for similarly situated companies, including commencement of Clinical Trials, significant factual information with respect to Clinical Trials (including numbers of patients, centers, investigators, descriptions of protocols, completion of enrollment and of treatment under Clinical Trials, safety and efficacy data and other results of Clinical Trials) and filings with and actions by Regulatory Authorities. Prior to publicly disclosing any such Collaboration Product achievement, including any results of Clinical Trials, the disclosing Party will provide the other Party with a copy of such disclosure no later than [**] business days in advance, or if such advance notice is not practicable under the circumstances, as much advance notice as the disclosing Party can reasonably provide (if any) and shall take into account the good faith and reasonable comments made by the other Party
within such period.
5. CONSIDERATION.
5.1. Upfront Payments. In consideration of the rights granted to AstraZeneca under this Agreement and the investment incurred for HMPL-504 by Hutchison prior to the date of this Agreement, AstraZeneca shall, upon receipt of an invoice, make a payment of Twenty Million Dollars ($20,000,000) on the Effective Date as an upfront, non-creditable, non-refundable fee to Hutchison, and such fee will not be reduced by the amount of any Indirect Taxes or Withholding Taxes required to be paid by AstraZeneca under any Applicable Law, subject, however, to Section 5.8.2 and 5.8.3.
5.2. Milestones.
5.2.1. Development Milestones . As additional consideration for the rights granted to AstraZeneca under this Agreement, except as otherwise set forth below, AstraZeneca will pay Hutchison, upon receipt of an invoice, the following non-creditable, non-refundable (except as set forth in Section 9.3) amounts, within [**] after the first occurrence of each of the following events (each, a Development Milestone ). For the avoidance of doubt, each Development Milestone shall be paid only once during the Term, regardless of the number of Collaboration Compounds or Collaboration Products that achieve the corresponding Milestone Event:
EVENT |
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MILESTONE PAYMENT |
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Initiation of the first Phase I Clinical Trial in China |
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$ |
5,000,000 |
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[**] |
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[**] |
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Initiation of the first Phase IIb Clinical Trial in the Secondary Indication (or an indication having equal or greater market potential as Secondary Indication) |
|
$ |
5,000,000 |
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[**] |
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[**] |
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[**] |
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[**] |
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[**] |
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[**] |
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EVENT |
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MILESTONE PAYMENT |
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[**] |
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[**] |
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[**] |
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[**] |
In determining whether, for the purposes of this Section 5.2.1, an indication has equal or greater market potential as the Primary Indication or the Secondary Indication as the case may be, the JSC shall meet to discuss in good faith whether such indication does, in fact, have equal or greater market potential. [**].
Any Development Milestone payable under this Section 5.2.1 will not be reduced by the amount of any Indirect Taxes or Withholding Taxes required to be paid by AstraZeneca under any Applicable Law, subject, however, to Section 5.8.2 and 5.8.3.
5.2.2. Sales Milestones . As further consideration for the rights granted to AstraZeneca under this Agreement, AstraZeneca will pay Hutchison upon receipt of an invoice the following non-creditable, non-refundable amounts within [**] days after the first occurrence of the following events (each, a Sales Milestone ):
EVENT |
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MILESTONE PAYMENT |
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[**] |
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[**] |
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[**] |
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[**] |
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[**] |
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[**] |
5.2.3. Notice of Milestone Event . AstraZeneca shall notify Hutchison as promptly as reasonably practicable after the occurrence of each Development Milestone and each Sales Milestone, but in no event later than ten (10) days after the occurrence thereof.
5.3. Royalties . In addition to the payments under Sections 5.1 and 5.2, in consideration for the rights granted to AstraZeneca under this Agreement, AstraZeneca shall pay to Hutchison the royalty payments set forth in this Section 5.3, as such may be adjusted pursuant to the terms hereof.
5.3.1. China Royalty . During the Royalty Period, subject to Section 5.3.3, AstraZeneca shall pay to Hutchison, on a Collaboration Product-by- Collaboration Product basis, an amount equal to [**] of annual aggregate Net Sales of each such Collaboration Product in the Field in China in such Calendar Year (or portion thereof).
5.3.2. Rest of World Royalty . During the applicable Royalty Period, subject to Section 5.3.3, AstraZeneca shall pay to Hutchison, on a country-by-country and Collaboration Product-by- Collaboration Product basis, the following amounts:.
(a) [**] of Net Sales in each Calendar Year (or portion thereof) for the portion of annual aggregate Net Sales of such Collaboration Product in the Field in the ROW Territory below or equal to [**]; plus
(b) [**] of Net Sales in each Calendar Year (or portion thereof) for the portion of annual aggregate Net Sales of such Collaboration Product in the Field in the ROW Territory greater than [**] and less than or equal to [**]; plus
(c) [**] of Net Sales in each Calendar Year (or portion thereof) for the portion of annual aggregate Net Sales of such Collaboration Product in the Field in the ROW Territory greater than [**].
5.3.3. Adjustments in Royalty Rates . On a country-by-country basis [**] AstraZeneca shall owe royalties under Section 5.3 (as applicable to such country) on the amount of the Net Sales of such Collaboration Product in such country at rates that are [**] of the rates otherwise payable under such Section 5.3 for the remainder of the Royalty Period.
5.4. Sales Subject to Royalties. Sales of Collaboration Product between AstraZeneca, its Affiliates and Sublicencees that are purchased for re-sale shall not be subject to royalties hereunder. Royalties shall be calculated on AstraZenecas and its Affiliates sale of the
Collaboration Products to Third Parties (including distributors). Royalties shall be payable only once per unit of Collaboration Product.
5.5. Fully Paid-Up, Royalty Free License . Following the expiration of the Royalty Period for any Collaboration Product in a given country of the Territory, no further royalties shall be payable in respect of Net Sales of such Collaboration Product in such country and, thereafter, the license granted to AstraZeneca under Section 2.2 with respect to such Collaboration Product in such country shall automatically become a fully paid-up, perpetual, irrevocable, non-terminable, royalty-free, non-exclusive license.
5.6. Third Party Intellectual Property . Neither Party shall negotiate or enter into any New Third Party License without first discussing such new Third Party License at the Joint Steering Committee and complying with the provisions of this Section 5.6.
5.6.1. Terms of New Third Party Licenses . If, during the Term and after consultation with Hutchison, AstraZeneca enters into an agreement with a Third Party in order to obtain a royalty bearing license under any Patent Right of a Third Party that, in AstraZenecas reasonable judgment, would be necessary for the Development, Manufacture or Commercialization of the Collaboration Compound or Collaboration Product in the Field in the Territory (a New Third Party License ), then AstraZeneca shall be entitled, on a Collaboration Product-by-Collaboration Product and country-by-country basis, to credit against any royalty payable to Hutchison under Section 5.3.1 or 5.3.2 [**] of any royalty (but no other payments) (the Hutchison Portion ) actually paid by or on behalf of AstraZeneca to such Third Party as a result of such sale; provided , however , that in no event shall any royalty payable to Hutchison be reduced as a result of this Section 5.6.1 by more than [**] of the amount otherwise due to Hutchison with respect to such sale. In addition, any such Hutchison Portion shall not reduce the amounts due to Hutchison under Section 5.3 in any Calendar Quarter by more than [**] of the amounts otherwise due. Any deductions of a Hutchison Portion to which AstraZeneca is entitled under this Section 5.6.1 may be carried forward to the next Calendar Quarter until fully exhausted.
5.6.2. Sublicensing of New Third Party Licenses . Such New Third Party License shall be (a) sublicensable to the Hutchison for purposes of Hutchison conducting activities or potential activities permitted under this Agreement and for performing obligations under this Agreement and (b) assignable to Hutchison in the event of a termination of this Agreement. In the event AstraZeneca is unable to negotiate a New Third Party License that is sublicensable and assignable to Hutchison to the extent set forth above, then the Parties will meet and discuss how to proceed.
5.6.3. New Third Party Licenses Applicable only to Hutchison . If any intellectual property rights Controlled by a Third Party are necessary or useful only for Hutchison to conduct activities or to perform obligations under this Agreement, then Hutchison shall be free to enter into a New Third Party License for such intellectual property to Develop the applicable Collaboration Product anywhere in the world, solely for purposes of obtaining Regulatory Approval for such Collaboration Product.
5.7. Development Costs.
5.7.1. Definitions . As used in this Section 5.7, the following terms shall have the following meanings.
(a) China Development Activities means (a) all Development activities relating to chemistry, manufacturing and control of the Collaboration Product and (b) all Development activities (other than Translational Research Activities) that (i) are conducted outside of China but are intended to directly support obtaining Regulatory Approval for a Collaboration Product in China, including the Phase I Clinical Trial for the Collaboration Product contemplated by the Parties on the Effective Date to be conducted in Australia, or (ii) are conducted inside of China.
(b) China Translational Costs means all Translational Costs associated with Translational Research Activities that (i) are conducted outside of China but are principally related to obtaining Regulatory Approval for a Diagnostic Product in China or (ii) are conducted inside of China.
(c) Development Costs means all direct costs specifically identifiable or allocable to Development of a Collaboration Product and actually incurred by a Party or its Affiliates (it being understood that direct costs excludes overhead), including (a) reasonable costs of supplies and materials related to the foregoing and (b) reasonable amounts paid to Third Parties performing activities on behalf of such Party or its Affiliates, in all cases, to the extent such Development activities are specified in the Development Plan.
(d) Global Translational Costs means Translational Costs, other than China Translational Costs, associated with Translational Research Activities that are performed in support Regulatory Approval for a Diagnostic Product in the entire Territory.
(e) Manufacturing Costs means all direct costs specifically identifiable or allocable to Manufacture of Collaboration Compound and Collaboration Product for use in China and actually incurred by a Party or its Affiliates (it being understood that direct costs excludes overhead), including (a) reasonable costs of supplies and materials related to the foregoing and (b) reasonable amounts paid to Third Parties performing activities on behalf of such Party or its Affiliates.
(f) Shared Development Costs means (i) all Development Costs associated with China Development Activities and (ii) all Manufacturing Costs associated with the Manufacture of Collaboration Compound and Collaboration Product for use in China.
(g) Translational Costs means all direct costs specifically identifiable or allocable to performance of the Translational Research Activities and actually incurred by a Party or its Affiliates (it being understood that direct costs excludes overhead), including (a) reasonable costs of supplies and materials
related to the foregoing and (b) reasonable amounts paid to Third Parties performing activities on behalf of such Party or its Affiliates, in all cases, to the extent such Translational Research Activities are specified in the Development Plan.
(h) Translational Cost Cap means, with respect to amounts owed by Hutchison in respect of Global Translational Costs and China Translational Costs pursuant to Section 5.7.3, an aggregate amount equal to [**].
5.7.2. Allocation of Development Costs .
(a) Hutchison shall be responsible for paying [**] of the Shared Development Costs, and AstraZeneca shall be responsible for paying [**] of the Shared Development Costs.
(b) [**].
5.7.3. Allocation of Translational Costs.
(a) Subject to Section 5.7.3(c), Hutchison shall be responsible for paying [**] of Global Translational Costs, and AstraZeneca shall be responsible for paying [**] of Global Translational Costs.
(b) Subject to Section 5.7.3(c), Hutchison shall be responsible for paying [**] of China Translational Costs, and AstraZeneca shall be responsible for paying [**] of China Translational Costs.
(c) Notwithstanding anything to the contrary contained herein, in no event shall Hutchison be obligated to make any out-of-pocket payments under Section 5.7.3(a) or 5.7.3(b) for the performance of Translational Research Activities that exceed, in the aggregate, the Translational Cost Cap. Any amounts owed by Hutchison under such provisions that exceed the Translational Cost Cap may be deducted from the next applicable payment owed by AstraZeneca to Hutchison under Section 5.2.1 or 5.2.2; provided , however , that any such deduction shall not reduce the amounts due to Hutchison under Section 5.2.1 or 5.2.2 in any Calendar Quarter by more than [**] of the amounts otherwise due. Any deductions to which AstraZeneca is entitled under this Section 5.7.3(c) may be carried forward until fully exhausted.
5.7.4. Costs outside the Development Plan . [**].
5.8. Reports and Payments.
5.8.1. Royalty Reports . Within [**] days after the end of each Calendar Quarter beginning with the Calendar Quarter in which the First Commercial Sale is made in a country following receipt of Regulatory Approval in such country, AstraZeneca shall deliver to Hutchison a report setting forth for the previous Calendar Quarter the following information on a Collaboration Product-by-Collaboration Product basis: (a) the Net Sales of each Collaboration Product in each country, (b) the number of units sold by Hutchison, its Affiliates or Sublicensees, (c) the basis for any adjustments to the royalty payable for the sale of each Collaboration Product, (d) the royalty due hereunder for the sales of each Collaboration Product, and (e) the applicable exchange rate as determined in accordance with this Agreement. The total royalty due for the sale of Collaboration Products during such Calendar Quarter shall be remitted at [**]. No such reports shall be due for any Collaboration Product after the relevant Royalty Period for such Collaboration Product has expired.
5.8.2. Withholding Tax .
(a) [**].
(b) [**].
(g) [**].
5.8.3. Indirect Taxes . Notwithstanding anything contained in Section 5.8.2, this Section 5.8.3 shall apply with respect to Indirect Taxes. All payments under this Agreement are stated exclusive of Indirect Taxes. If any Indirect Taxes are chargeable in respect of any Payments, the remitting Party shall pay Indirect Taxes at the applicable rate in respect of any such Payments following the receipt of an Indirect Taxes invoice in the appropriate form issued by receiving Party in respect of those payments, such Indirect Taxes to be payable on the later of the due date of the payment to which such Indirect Taxes relates and sixty (60) days after the receipt by the remitting Party of the applicable invoice relating to that Indirect Taxes payment. The Parties shall issue invoices for all goods and services supplied under this Agreement consistent with Indirect Taxes requirements and irrespective of whether the sums may be netted for settlement purposes.
5.8.4. Currency . All amounts payable and calculations hereunder shall be in United States dollars. As applicable, Net Sales and any royalty deductions shall be translated into United States dollars in accordance with the paying Partys customary and usual currency conversion procedures, consistently applied. If, due to restrictions or prohibitions imposed by national or international authority, payments cannot be made as provided in this Section 5, the Parties shall consult with a view to finding a prompt and acceptable solution, and the paying Party shall deal with such monies as the other Party may lawfully direct at no additional out-of-pocket expense to the paying Party.
5.8.5. Method of Payment . Except as permitted pursuant to Section 5.8.4, each payment hereunder shall be made by electronic transfer in immediately available funds via a bank wire transfer, an automated clearing house (ACH) mechanism or any other means of electronic funds transfer, at the paying Partys election, to the bank account designed by the Party receiving payments under this Section 5 in writing to the paying Party at least thirty (30) days before the payment is due.
5.8.6. Record Keeping . AstraZeneca shall keep, and shall causes its Affiliates and Sublicensees to keep, books and accounts of record in connection with the sale of Collaboration Products, including records of gross invoiced sales, Net Sales, exchange rates and royalty payments (collectively, the Financial Records ), in accordance with IFRS or GAAP (as appropriate) and in sufficient detail to permit accurate determination of all figures necessary for verification of royalties and Sales Milestone payments to be made by AstraZeneca under this Section 5. AstraZeneca and its Affiliates and Sublicensees shall maintain such records for a period
of at least three (3) years after the end of the Calendar Quarter in which they are generated.
5.8.7. Audits . Upon thirty (30) days prior written notice from Hutchison, AstraZeneca shall permit an independent certified public accounting firm of nationally recognized standing selected by Hutchison and reasonably acceptable to AstraZeneca, to examine, at Hutchisons sole expense, the relevant Financial Records of AstraZeneca and its Affiliates and Sublicensees as may be reasonably necessary to verify the amounts reported by AstraZeneca in accordance with Section 5.8.1 and the royalties and Sales Milestone payments made by AstraZeneca in accordance with this Section 5. Hutchison shall be entitled to conduct an audit in accordance with this Section 5.8.7 not more than once in any Calendar Year and such audit shall be limited to the pertinent Financial Records from any Calendar Year ending not more than three (3) years prior to the date of the request. The accounting firm shall be provided access to such Financial Records at AstraZenecas facility(ies) where such Financial Records are normally kept and such audit shall be conducted during Astra Zenecas normal business hours. Upon completion of the audit, the accounting firm shall provide both Parties with a written report disclosing any discrepancies in the reports submitted by AstraZeneca or payments made by AstraZeneca, if any, and in each case, the specific details concerning any discrepancies. Any information provided by AstraZeneca to the accounting firm and the written report of the accounting firm shall be the Confidential Information of AstraZeneca.
5.8.8. Underpayments/Overpayments . If a report of an independent public accounting firm submitted to the Parties in accordance with Section 5.8.7 shows any underpayment of royalties and Sales Milestone payments due under this Section 5, AstraZeneca shall remit to Hutchison within [**] days after receipt of such report by AstraZeneca, (a) the amount of such underpayment and (b) if such underpayment exceeds [**] of the total amount owed to Hutchison for the Calendar Year then being audited, the reasonable fees and expenses of such independent public accounting firm performing the audit, subject to reasonable substantiation thereof. If such independent public accounting firms written report shows any overpayment of royalties and Sales Milestone payments due under this Section 5, AstraZeneca shall receive a credit equal to such overpayment against the royalties and Sales Milestone payments due under this Section 5 otherwise payable to Hutchison.
5.8.9. Interest. Any payment under this Section 5 that is more than [**] days past due shall be subject to interest at an annual percentage rate of the Prime Rate (as published in the Money Rates table of the Eastern Edition of The Wall Street Journal during period such amount is overdue) plus [**] if Hutchison does not make payment within [**] days of its receipt of notice that such amount is past due. Likewise, any overpayment that is not refunded within [**] days after the date such overpayment was made shall thereafter be subject to interest at an annual percentage rate of the Prime Rate (as published in the Money Rates table of the Eastern Edition of The Wall Street Journal during the period such amount is overdue) plus [**]; provided , however , that if the overpayment is due to errors in reports provided by AstraZeneca, such interest shall accrue from the date the overpayment was made. Notwithstanding the preceding, if a Party contests any amounts due hereunder in good faith and promptly notifies the other Party of such dispute, interest shall not accrue as to amounts being so contested until [**] days following the presentation of such notice to the other Party.
6. COVENANTS.
6.1. Confidentiality.
6.1.1. Confidential Information . Except to the extent expressly permitted by this Agreement and subject to the provisions of Sections 6.1.2 and 6.1.3, at all times during the Term and for five (5) years following the expiration or termination hereof, each Party (the Receiving Party ) receiving any Confidential Information of the other Party (the Disclosing Party ) in connection with this Agreement shall: (a) keep completely confidential and shall not publish or otherwise disclose any Confidential Information furnished to it by the Disclosing Party, except to those of the Receiving Partys employees, Affiliates, consultants or representatives who have a need to know such information (collectively, Recipients ) to perform such Partys obligations or exercising its rights hereunder and (b) shall not use Confidential Information of the Disclosing Party directly or indirectly for any purpose other than performing its obligations or exercising its rights hereunder. The Receiving Party shall be liable for any breach by any of its Recipients of the restrictions set forth in this Agreement. Notwithstanding the foregoing, in no event, except as permitted under Section 6.1.3, shall Hutchison disclose any Confidential Information relating to the Collaboration Compound or Collaboration Product to any party that becomes an Affiliate of Hutchison as a result of a Change of Control without the prior written consent of AstraZeneca.
6.1.2. Exceptions to Confidentiality . The Receiving Partys obligations set forth in this Section shall not extend to any Confidential Information of the Disclosing Party:
(a) that is or hereafter becomes part of the public domain through no wrongful act, fault or negligence on the part of a Receiving Party or its Recipients;
(b) that is received from a Third Party without restriction and without breach of any agreement or fiduciary duty between such Third Party and the Disclosing Party;
(c) that the Receiving Party can demonstrate by competent evidence was already in its possession without any limitation or restriction on use or disclosure prior to its receipt from the Disclosing Party;
(d) that is generally made available to Third Parties by the Disclosing Party without any restriction imposed by the Disclosing Party on disclosure, whether such restriction is by contract, fiduciary duty or by operation of law; or
(e) that the Receiving Party can demonstrate by competent evidence was independently developed by the Receiving Party without any reference to Confidential Information.
6.1.3. Authorized Disclosure . Notwithstanding the provisions of Section 6.1.1, the Receiving Party and its Recipients may disclose Confidential Information belonging to the Disclosing Party to the extent that such disclosure is reasonably necessary to:
(a) Prosecute or defend litigation;
(b) Comply with applicable governmental laws and regulations (including applicable law, rule or regulation or the requirements of a national securities exchange or another similar regulatory body);
(c) Make filings and submissions to, or correspond or communicate with, any Government Authority.
In the event that the Receiving Party or its Recipients, as applicable, deem it reasonably necessary to disclose Confidential Information belonging to the Disclosing Party pursuant to this Section 6.1.3, the Receiving Party shall, to the extent possible, provide the Disclosing Party with reasonable advance notice of such disclosure and take reasonable measures (including for example, where appropriate, the filing of a redacted copy of this Agreement approved by both Parties) to ensure confidential treatment of such information. In addition, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party to any Third Party who is performing diligence in connection with a transaction with the Receiving Party (including potential Sublicensees and licensees) and to any Third Party performing work contemplated by this Agreement; provided that, each such Third Party has signed a written confidentiality agreement with the Receiving Party that is no less restrictive than the terms hereof.
6.1.4. Notification . The Receiving Party shall notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Partys discovery of any loss or compromise of the Disclosing Partys Confidential Information.
6.1.5. Destruction of Confidential Information . Upon the expiration or earlier termination of this Agreement, except with respect to Confidential Information necessary or useful for a Receiving Party to exercise any rights or perform any obligations under this Agreement surviving such expiration or termination, the Receiving Party shall (a) destroy all tangible embodiments of Confidential Information of the Disclosing Party, including any and all copies thereof, and those portions of any documents, memoranda, notes, studies and analyses prepared by the Receiving Party or its Recipients that contain, incorporate or are derived from such Confidential Information and provide written certification of such destruction to the Disclosing Party in a form reasonably acceptable to the Disclosing Party, provided that the legal department of the Receiving Party shall have the right to retain one (1) copy of any such tangible embodiments for archival purposes, provided such copy shall continue to be maintained on a confidential basis subject to the terms of this Agreement, and (b) immediately cease, and shall cause its Recipients to cease, use of such Confidential Information as well as any information or materials that contain, incorporate or are derived from such Confidential Information.
6.1.6. Use of Name and Disclosure of Terms . Each Party shall keep the existence of, the terms of and the transactions covered by this Agreement confidential and shall not disclose such information to any Third Party through a press release or otherwise, or mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in any manner without the prior written consent of the other Party in each instance (which shall not be unreasonably withheld); provided , however , that a Receiving Party may
disclose such information without the prior consent of the Disclosing Party to any Third Party who is performing diligence in connection with a transaction with such Receiving Party (including potential Sublicensees and licensees) so long as each such Third Party has signed a written confidentiality agreement with such Receiving Party no less restrictive than the terms hereof. The restrictions imposed by this Section 6.1.6 shall not prohibit either Party from making any disclosure that is required by applicable law, rule or regulation or the requirements of a national securities exchange or another similar regulatory body, including disclosing such information in any clinical trial database maintained by or on behalf of a Party, or that is expressly permitted under this Agreement. Further, the restrictions imposed on each Party under this Section 6.1.6 are not intended, and shall not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to this Section 6.1.6.
6.1.7. Remedies . The Parties acknowledge and agree that the restrictions set forth in Section 6.1 are reasonable and necessary to protect the legitimate interests of the Parties and that neither Party would have entered into this Agreement in the absence of such restrictions, and that any breach or threatened breach of any provision of Section 6.1 will result in irreparable injury to the other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of Section 6.1 by a Party, the other Party shall be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights shall be cumulative and in addition to any other rights or remedies to which such Party may be entitled in law or equity. The breaching Party agrees to waive any requirement that the non-breaching Party (a) post a bond or other security as a condition for obtaining any such relief and (b) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 6.1.7 is intended, or shall be construed, to limit the Parties rights to equitable relief or any other remedy for a breach of any provision of this Agreement.
6.2. Compliance with Law. Each Party hereby covenants and agrees to comply with all laws applicable to its activities connected with the Development, Manufacture and Commercialization (as applicable) of Collaboration Products. Without limiting the generality of the foregoing:
6.2.1. Patient Information . Each Party agrees to abide by all laws, rules, regulations, and orders of all applicable supranational, national, federal, state, provincial, and local governmental entities concerning the confidentiality or protection of patient identifiable information or patients protected health information in the course of their performance under this Agreement.
6.2.2. Export Controls . This Agreement is made subject to any restrictions concerning the export of products or technical information from the United States or other countries which may be imposed upon or related to Hutchison or AstraZeneca from time to time. Each Party agrees that it shall not export, directly or indirectly, any technical information acquired from the other Party pursuant to this Agreement or any Collaboration Products using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate
agency or other governmental entity.
6.2.3. Debarment . Each Party agrees that it shall not knowingly use, in any capacity, in connection with any of its obligations to be performed under this Agreement any individual who has been disqualified or debarred by the United States Food and Drug Administration, pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted under United States law for conduct relating to the development or approval, or otherwise relating to the regulation of Collaboration Product under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation or been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation.
6.3. Anti-Corruption Laws .
6.3.1. Compliance with Anti-Corruption Law . In carrying out their responsibilities under this Agreement, the Parties shall comply with all applicable anti-corruption laws in the countries where the Parties have their principal or other places of business and where they conduct activities under this Agreement. Additionally, the Parties understand and agree to comply with the U.S. Foreign Corrupt Practices Act of 1977 ( US Act ) and the UK Bribery Act of 2010 ( UK Act ), in each case as revised, which in the case of the US Act generally prohibits the promise, payment or giving of anything of value either directly or indirectly to any government official for the purpose of obtaining or retaining business or any improper advantage, and in the case of the UK Act includes the prohibition on the making of any bribe to a foreign public official with the intention of influencing such person in order to obtain or retain business or an advantage in the conduct of business. For purposes of this section, (a) government official means any official, officer, representative, or employee of, including any doctor employed by, any non-U.S. government department, agency or instrumentality (including any government-owned or controlled commercial enterprise), or any official of a public international organization or political party or candidate for political office; and (b) foreign public official means an individual who holds a legislative, administrative or judicial position of any kind, whether appointed or elected, of a country or territory outside the United Kingdom (or any subdivision of such a country or territory); exercises a public function (i) for or on behalf of a country or territory outside the United Kingdom (or any subdivision of such a country or territory), or (ii) for any public agency or public enterprise of that country or territory (or subdivision); or is an official or agent of a public international organization.
6.3.2. Certain Covenants regarding Anti-Corruption . Additionally, each Party represents and warrants to the other Party that neither it nor any of its, directors, employees, agents, consultants (or any other person who may be associated with a Party for the purposes of the UK Act) will directly or indirectly pay or give or promise to pay or give anything of value to any government official or a foreign public official for purposes of (a) influencing any act or decision of any such person in his official capacity; (b) inducing such person to do or omit to do any act in violation of the lawful duty of such official; (c) securing any improper advantage; or (d) inducing such person to use his position to affect or influence any act or decision of government or any legislative, administrative, public agency or other public body with respect to any activities undertaken relating to this Agreement. Additionally, the Parties will make reasonable efforts to comply with requests for information, including answering questionnaires
and narrowly tailored audit inquiries, to enable the other Party to ensure compliance with any applicable anti-corruption laws.
6.3.3. Breach of Anti-Corruption Covenants . The Parties agree that a breach of the anti-corruption commitments in Section 6.3 shall be considered a material breach of this Agreement and that either Party may immediately seek all remedies available under law and equity including termination of this Agreement pursuant to Section 10.3.1 if it believes, in good faith, that the covenants under the anti-corruption commitments in this Section 6.3 have been breached by the other Party, without owing to the other any damages or indemnification resulting solely from such termination.
6.4. Exclusivity .
6.4.1. Scope of Exclusivity . Each Party agrees that, from the Effective Date until the earlier of (x) [**] and (y) the date that is [**] years after the Effective Date (the Exclusivity Period ), the following restrictions shall apply:
(a) Neither Party nor its Affiliates or Sublicensees shall, directly or indirectly, Develop, Manufacture or Commercialize any Collaboration Compound, except as set forth in the Development Plan or as otherwise set forth herein.
(b) Except as expressly permitted under this Section 6.4, neither Party shall develop, manufacture or commercialize any Agreement Compound, independently or for or with any of its Affiliates or any Third Party (including through the grant of any license to any Third Party); provided , however , [**]. For the avoidance of doubt, in no event shall either Party conduct any Clinical Trial of any Agreement Compound, including any Back-Up Compound, without the prior written consent of the other Party.
6.4.2. Acquisition of Agreement Compound . A Party will not be deemed to be in breach of the restrictions set forth in Section 6.4.1(b) if such Party or any of its Affiliates acquires, through an acquisition of or a merger with the whole or substantially the whole of the business or assets of another Person, an Agreement Compound that such Person is developing in the clinic, manufacturing or commercializing, independently or for or with any of its Affiliates or any Third Party (including though the grant of a license to any Third Party) (such activities, the Restricted Activities ), so long as such Party (or its Affiliate) [**]. As used in this Section 6.4.2, the following terms shall have the following meanings.
(a) Hold Separate Transaction means any hold separate transaction (whether through the establishment of a trust or otherwise) involving the proposed sale of an Agreement Compound pursuant to an agreement with any Government Authority responsible for antitrust laws.
(b) Divest or Divestiture means, with respect to any Agreement Compound, (i) the sale, exclusive license or other transfer of all of the right, title and interest in and to such Agreement Compound, including all technology, intellectual property and other assets relating solely thereto, to an independent Third Party, without the retention or reservation of any rights, license or interest (other than customary residual rights in the event of a termination) in such Agreement Compound and (ii) the complete shutdown of the Agreement Compound such that no technology, intellectual property or other asset relating thereto is used by the applicable Party or its Affiliates and delivery of written confirmation from such Party to the other Party that such Party and its Affiliates covenant not to use any technology, intellectual property and assets solely relating to such Agreement Compound during the Exclusivity Period.
6.4.3. Breach of Exclusivity . If, at any time during the Exclusivity Period, a Party is in breach of the restrictions set forth in Section 6.4.1(b), then the other Party shall have the right to terminate this Agreement immediately upon providing written notice of such termination, in which case the effects of termination set forth in Section 10.4.2 shall apply.
6.5. Change of Control .
6.5.1. Notice . In the event of any Change of Control that occurs during the Term, Hutchison shall notify AstraZeneca promptly thereof, but in no event later than [**] Business Days following execution of the definitive agreement contemplating the transaction that would constitute such Change of Control. Upon receipt of such notice, AstraZeneca shall have the right, by submitting written notice to Hutchison no later than [**] days after the closing of such Change of Control (such notice, the COC Amendment Notice ), to amend this Agreement in accordance with the terms and conditions set forth in Sections 6.5.2 and 6.5.3 (such amendment, a COC Amendment ). In the event that AstraZeneca submits a COC Amendment Notice, the Parties will enter into an appropriate and customary written amendment reflecting the terms and conditions set forth in Sections 6.5.2 and 6.5.3.
6.5.2. Change of Control before [**]. Where a Change of Control occurs at any time prior [**], any COC Amendment shall contain the following terms:
[**]
[**]
[**]
[**]
[**]
[**]
[**]
[**]
6.5.3. Change of Control after [**]. Where a Change of Control occurs at any time after the [**], any COC Amendment shall contain the following terms:
(a) Hutchison shall, and hereby does, assign to AstraZeneca all right, title and interest in and to: (i) Hutchison Patent Rights and Joint Patent Rights, all Regulatory Submissions and Regulatory Approvals Controlled by Hutchison or any Affiliate pertaining to Collaboration Compound, Collaboration Product and Diagnostic Products in the Field in the Territory and (ii) all of [**];
6.6. Non-Solicitation. During the Term, neither Party nor any of its Affiliates shall, directly or indirectly, anywhere in the Territory solicit for employment, any person engaged in the Development, Manufacture or Commercialization of any Collaboration Compound or Collaboration Product employed by either Party or their Affiliates, during the period such person is so employed or for [**] after termination of such persons employment provided that such restriction shall not apply in the case where such employee responds to an advertisement of employment made by either Party in the normal course of their business.
7. REPRESENTATIONS AND WARRANTIES.
7.1. Representations and Warranties of Each Party. As of the Effective Date, each of AstraZeneca and Hutchison hereby represents and warrants to the other Party hereto as follows:
7.1.1. it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or formation;
7.1.2. the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval;
7.1.3. it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;
7.1.4. the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions does not and shall not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound; and
7.1.5. it has the full right, power and authority to grant all of the right, title and interest in the licenses granted to the other Party under this Agreement.
7.2. Additional Representations and Warranties of Hutchison. Hutchison hereby represents and warrants to AstraZeneca that as of the Effective Date:
7.2.1. Hutchison, together with its Affiliates, is the sole and exclusive owner of, and has the sole right, title and interest in and to, the Hutchison Patent Rights and the Hutchison Know-How, in each case free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien, lease, sublease, option, or charge of any kind, limitations on transfer or any subordination arrangement in favor of a Third Party;
7.2.2. All of the Hutchison Patent Rights listed on Schedule 1.49 are in force or pending and have not been abandoned as of the Effective Date, and to Hutchisons knowledge, all such Hutchison Patent Rights are valid and enforceable;
7.2.3. No Third Party has challenged or has threatened in writing to challenge the extent, validity or enforceability of the patents encompassed within the Hutchison Technology relating to the Collaboration Compound (including, by way of example, through the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the US Patent and Trademark Office or any analogous foreign entity), and to the knowledge of Hutchison, all application, registration, maintenance and renewal fees in respect of Hutchison Patent Rights have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Hutchison Patent Rights have been filed;
7.2.4. Neither Hutchison nor any of its Affiliates has granted any license, option or other rights of any kind to or in favor of a Third Party under the Hutchison Technology;
7.2.5. There is no intellectual property right, and in particular no Patent Right, owned or Controlled by Hutchison or its Affiliates other than the Hutchison Technology, that is necessary for AstraZeneca or its Affiliates and subcontractors to Develop a Collaboration Compound as set forth herein;
7.2.6. To Hutchisons knowledge, the manufacture, use, sale, offer for sale and importation of the Collaboration Compound in the Field in the Territory, in the form in which it is being Developed by Hutchison as of the Effective Date, does not infringe any Patent Rights of a Third Party;
7.2.7. There are no claims, judgments or settlements pending against Hutchison or its Affiliates with respect to any Hutchison Technology, and Hutchison has not received notice that any such claims, judgments or settlements are threatened; and
7.2.8. All employee inventions relevant to the rights granted to AstraZeneca under this Agreement have been duly transferred to Hutchison or its Affiliates in accordance with Applicable Law or Hutchison has entered into binding agreements permitting such a transfer; and
7.2.9. Hutchison has heretofore disclosed or made available to AstraZeneca all material scientific and technical information and all material information relating to safety and efficacy known to it or its Affiliates with respect to the Collaboration Compound and has made available to AstraZeneca complete and accurate copies of all material documentation and correspondence submitted to or received from any Regulatory Authority with respect to the Collaboration Compound.
7.3. Representation by Legal Counsel. Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.
7.4. No Inconsistent Agreements. Neither Party has in effect and after the Effective Date neither Party shall enter into any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement or limit the ability of either Party to grant the licenses set forth in Section 2 of this Agreement.
7.5. Disclaimer. THE FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTIES OF NONINFRINGEMENT, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE ALL OF WHICH ARE HEREBY SPECIFICALLY EXCLUDED AND DISCLAIMED. EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF ANY PRODUCT UNDER THIS AGREEMENT WILL BE SUCCESSFUL.
8. INTELLECTUAL PROPERTY.
8.1. Disclosure. During the Term, the Parties shall promptly disclose to one another all Collaboration Know-How (whether patentable or not).
8.2. Ownership.
8.2.1. Ownership of Technology . Determinations as to which Party has Invented any Patent Right or Know-How shall be made in accordance with the standards of inventorship under the patent laws of the United States. Subject to the license grants under Section 2 of this Agreement, as between the Parties, [**]. Neither Party shall take any action that would limit the other Partys right to exercise its rights under Section 2.4. In the event inventorship and ownership of any Collaboration Technology cannot be resolved by the Parties with advice of their respective intellectual property counsel, such dispute shall be resolved through the dispute resolution mechanism set forth in Section 12.1.
8.2.2. Employee Assignment . To the extent permissible under Applicable Laws, each Party will cause each employee and contractor conducting work on such Partys behalf under this Agreement to sign a contract that (a) compels prompt disclosure to the Party of all Hutchison Technology, AstraZeneca Technology, and Joint Technology, as applicable, conceived or reduced to practice by such employee or contractor during any performance under this Agreement, (b) automatically assigns to the Party all right, title and interest in and to all such Technology and all Patent Rights disclosing or claiming such Technology and (c) obligates such persons to similar obligations of confidentiality as set forth in this Agreement. Each Party will require each employee and contractor conducting work on such Partys behalf under this Agreement to maintain records in sufficient detail and in a good scientific manner appropriate for patent purposes to properly reflect all work done. Each Party shall be responsible for the payment of any remuneration due to employees under any Applicable Law which provides compensation to such employee inventors.
8.3. JIPC. The JIPC shall, from time to time, review and discuss the patent strategy for inventions made in the course of the Development and to coordinate patent strategy relating to the Collaboration Patent Rights, to the extent such Collaboration Patent rights are necessary or useful to Manufacture, Develop or Commercialize a Collaboration Compound or Collaboration Product.
8.4. Filing, Prosecution and Maintenance of Patent Rights.
8.4.1. Hutchison Patent Rights . AstraZeneca shall be responsible, at its sole cost and expense, for the preparation, filing and prosecution and maintenance of the Hutchison Patent Rights in the Territory. If AstraZeneca or its Affiliates use any of its employees to conduct any preparation, prosecution or maintenance activity under this Agreement, then neither AstraZeneca nor any Affiliate shall be liable to Hutchison in respect of any act or omission in undertaking such activity. In the event external counsel are used then no such exclusion of liability shall apply. AstraZeneca shall keep Hutchison advised on the status of preparation, filing, prosecution and maintenance of all patent applications included within the Hutchison Patent Rights and the maintenance of any issued patents within the Hutchison Patent Rights. Further, AstraZeneca shall consult and reasonably cooperate with Hutchison with respect to the preparation, filing, prosecution and maintenance of all Hutchison Patent Rights, including: (a) allowing Hutchison a reasonable opportunity and reasonable time to review and comment regarding relevant material communications and drafts of any material responses or proposed filings by AstraZeneca before any applicable filings are submitted to any relevant patent office or Government Authority and (b) reflecting any reasonable comments offered by Hutchison in any final filings submitted by AstraZeneca to any relevant patent office or Governmental Authority.
8.4.2. AstraZeneca Patent Rights . AstraZeneca shall have the sole and exclusive right to prepare, file, prosecute and maintain the AstraZeneca Patent Rights in the Territory, in its sole discretion.
8.4.3. Joint Patent Rights . AstraZeneca shall be responsible, at its sole cost and expense, for the preparation, filing and prosecution and maintenance of the Joint Patent Rights in the Territory. If AstraZeneca or its Affiliates use any of its employees to conduct any preparation, prosecution or maintenance activity under this Agreement, then neither AstraZeneca nor any Affiliate shall be liable to Hutchison in respect of any act or omission in undertaking such activity. In the event external counsel are used no such exclusion of liability shall apply. AstraZeneca shall keep Hutchison advised on the status of preparation, filing, prosecution and maintenance of all patent applications included within the Joint Patent Rights and the maintenance of any issued patents within the Joint Patent Rights. Further, AstraZeneca shall consult and reasonably cooperate with Hutchison with respect to the preparation, filing, prosecution and maintenance of all Joint Patent Rights, including: (a) allowing Hutchison a reasonable opportunity and reasonable time to review and comment regarding relevant material communications and drafts of any material responses or proposed filings by AstraZeneca before any applicable filings are submitted to any relevant patent office or Government Authority and (b) reflecting any reasonable comments offered by Hutchison in any final filings submitted by AstraZeneca to any relevant patent office or Governmental Authority.
8.4.4. Reversion Rights. If AstraZeneca decides not to file, prosecute or maintain any Patent Right under Section 8.4.1 or 8.4.3, it shall give Hutchison reasonable notice to that effect sufficiently in advance of any deadline for any filing with respect to such Patent Right so as to permit Hutchison to carry out such activity. Upon delivery of such notice, Hutchison shall have the right to file, prosecute and maintain such Patent Right, and AstraZeneca shall perform such acts as may be reasonably necessary for Hutchison to file, prosecute or maintain such Patent Right, at Hutchisons sole cost and expense. If Hutchison does so elect, then AstraZeneca shall
provide such cooperation to Hutchison, including the execution and filing of appropriate instruments, as may reasonably be requested to facilitate the transition of such patent activities, and shall assign all of its right, title and interest to such Patent Right to Hutchison. Any such Patent Right abandoned by AstraZeneca under Section 8.4.1 or 8.4.3 shall be deemed to be excluded from the Hutchison Patent Rights or Joint Patent Rights, as applicable, and shall thereafter cease to be included within the scope of the licenses granted to AstraZeneca under Section 2.
8.4.5. Patent Term Extensions . The Parties shall cooperate, if necessary and appropriate, with each other in gaining patent term extensions, including supplementary protection certificates and any other extensions that are now or become available in the future wherever applicable to Patent Rights that are applicable to the Collaboration Products. The Parties shall, if necessary and appropriate, use reasonable efforts to agree upon a joint strategy relating to patent term extensions, but, in the absence of mutual agreement with respect to any extension issue, a Patent Right shall be extended only as and if AstraZeneca elects to extend such Patent Right. All filings for such extension shall be made by AstraZeneca.
8.4.6. Orange Book Listing . Hutchison shall, at AstraZenecas expense and upon AstraZenecas reasonable request, (a) provide all necessary or reasonably useful information to enable AstraZeneca to make filings with Regulatory Authorities with respect to Hutchison Patent Rights or Joint Patent Rights as required (i) in the United States for the FDAs Orange Book and (ii) outside the United States under other international equivalents and (b) shall cooperate with AstraZeneca in connection therewith, including meeting any submission deadlines.
8.4.7. Costs and Expenses . [**] .
8.5. Trademarks.
8.5.1. Collaboration Product Trademarks . AstraZeneca shall select and own the Trademarks for the Collaboration Products and shall be solely responsible for applying for and maintaining the registrations for the Trademarks throughout the Territory, and all goodwill associated therewith will inure to the benefit of AstraZeneca. AstraZeneca shall bear all costs of applying for and maintaining registrations for the Trademarks. AstraZeneca shall assume full responsibility, at its sole costs and expense, for prosecuting any infringement of a Trademark by a Third Party, and shall be entitled to retain all recoveries in connection therewith. AstraZeneca shall own the Trademarks, and all applications and registrations therefor.
8.6. Enforcement of Technology Rights.
8.6.1. Notice . Each Party will promptly notify the other in the event of any actual, potential or suspected infringement of a patent under the Hutchison Patent Rights or the Joint Patent Rights by any Third Party (an Infringement ).
8.6.2. Enforcement . As between AstraZeneca and Hutchison, AstraZeneca shall have the first right, except as otherwise provided in this Section 8.6.2, but not the obligation, to institute litigation or take other steps to remedy an Infringement, and any such litigation or steps shall be at AstraZenecas expense subject to Hutchisons obligation to indemnify AstraZeneca for
such expenses pursuant to Section 11.1, provided that, any recoveries resulting from such litigation or steps relating to a claim of Infringement, after deducting AstraZenecas out of pocket expenses (including counsel fees and expenses) in pursuing such claim, will be deemed Net Sales of AstraZeneca. AstraZeneca shall have full control of such litigation or steps but shall not, without the prior written consent of Hutchison, enter into any compromise or settlement relating to such litigation that (a) admits the invalidity or unenforceability of any Hutchison Patent Right or Joint Patent Right or (b) requires AstraZeneca to abandon any Hutchison Patent Right or Joint Patent Right. In order to establish standing, Hutchison, upon request of AstraZeneca, agrees to timely commence or to join in any such litigation, at AstraZenecas expense, and in any event to cooperate with AstraZeneca in such litigation or steps at AstraZenecas expense. Hutchison shall have the right to consult with AstraZeneca about such litigation and to participate in and be represented by independent counsel in such litigation at Hutchisons own expense. If AstraZeneca fails to institute such litigation or otherwise take steps to remedy an Infringement of any Hutchison Patent Right or Joint Patent Right within [**] days of its receipt of notice thereof, then Hutchison shall have the right, but not the obligation, upon [**] days prior notice to AstraZeneca, at Hutchisons expense, to institute any such litigation and any proceeds from such litigation shall be retained by Hutchison. AstraZeneca shall, at Hutchisons expense, cooperate with Hutchison in any such litigation. Neither Party shall incur any liability to the other Party as a consequence of any litigation initiated or pursued pursuant to this Section 8.6.2 or any unfavorable decision resulting therefrom, including any decision holding any Hutchison Patent Right or Joint Patent Right invalid or unenforceable.
8.7. Third Party Claims.
8.7.1. Third Party Claims Course of Action . If the Development, Commercialization or Manufacture of a Collaboration Product under this Agreement is alleged by a Third Party to infringe a Third Partys Patent Right(s) or misappropriate a Third Partys trade secret, the Party becoming aware of such allegation shall promptly notify the other Party thereof, in writing, reasonably detailing the claim.
8.7.2. Third Party Suit . If a Third Party sues a Party (the Sued Party ) alleging that the Sued Partys or the Sued Partys Sublicensees Development, Manufacture or Commercialization of the Collaboration Compound or Collaboration Product infringes or shall infringe said Third Partys Patent Right(s) or misappropriates said Third Partys trade secret, [**] to defend or settle such claim in its own name after consultation with Hutchison and in connection with its defense of any such Third Party suit, Hutchison shall provide reasonable assistance to AstraZeneca for such defense and shall join such suit if deemed a necessary party. AstraZeneca shall keep Hutchison, if Hutchison has not joined in such suit, reasonably informed on a quarterly basis, in person or by telephone, prior to and during the pendency of any such suit. AstraZeneca shall not admit the invalidity of any patent within the Hutchison Patent Rights, the AstraZeneca Patent Rights or the Joint Patent Rights, nor settle any such suit, without written consent of the other Party, such consent not to be unreasonably withheld or delayed. Subject to Hutchisons indemnity obligations pursuant to Section 11.1, all litigation expenses, including settlement costs, royalties paid in settlement of any such suit, and the payment of any damages to the Third Party will be paid by AstraZeneca.
8.8. Patent Certifications . Each Party shall immediately give written notice to the other of any certification of which it becomes aware has been filed pursuant to 21 U.S.C. § 355(b)(2)(A), or § 355(j)(2)(A)(vii) or any amendment or successor statute thereto or any analog in any other jurisdiction claiming that the Hutchison Patent Rights or Joint Patent Rights covering a Collaboration Product are invalid or that infringement shall not arise from the manufacture, use, import sale or offer for sale of such Third Party product by a Third Party. AstraZeneca shall have the right, in the first instance, to commence an ANDA Proceeding in connection with any such certification. If AstraZeneca decides not to bring infringement proceedings against the Third Party making such a certification with respect to any Collaboration Product, AstraZeneca will give notice to Hutchison of its decision not to bring suit within [**] business days after receipt of notice of such certification (or, if the time period permitted by law is less than [**] business days, within half of the time period permitted by law for AstraZeneca to commence such action) and Hutchison may then, but shall not be obligated to, bring suit against the Third Party that filed the certification. Any suit by either Party may be in the name of either or both Parties, as may be required by law. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit as may be reasonably requested by the Party bringing suit.
8.9. No Implied Licenses. Except as expressly set forth in this Agreement, no right or license under any Hutchison Technology or AstraZeneca Technology is granted or shall be granted by implication as a result of the respective rights of the Parties under this Agreement. All such rights or licenses are or shall be granted only as expressly provided in this Agreement.
8.10. Privileged Communications. In furtherance of this Agreement, it is expected that AstraZeneca and Hutchison will, from time to time, disclose to one another privileged communications with counsel, including opinions, memoranda, letters and other written, electronic and verbal communications. Such disclosures are made with the understanding that they shall remain confidential, they will not be deemed to waive any applicable attorney-client privilege and that they are made in connection with the shared community of legal interests existing between Hutchison and AstraZeneca, including the community of legal interests in avoiding infringement of any valid, enforceable patents of Third Parties and maintaining the validity of Hutchison Patent Rights, AstraZeneca Patent Rights and Joint Patent Rights.
8.11. Create Act . This Agreement includes a joint research agreement as defined in 35 U.S.C. § 103(c)(3). Notwithstanding anything to the contrary in this Article 8, neither Party shall have the right to make an election under the Cooperative Research and Technology Enhancement Act of 2004, 35 U.S.C. 103(c)(2)-(c)(3) when exercising its rights under this Article 8 without the prior written consent of the other Party. With respect to any such permitted election, the Parties shall use reasonable efforts to cooperate and coordinate their activities with respect to any submissions, filings or other activities in support thereof.
9. GOVERNMENT APPROVALS.
9.1. AstraZenecas and Hutchisons Obligations. Each of AstraZeneca and Hutchison shall use its good faith efforts to eliminate any concern on the part of any court or
Government Authority regarding the legality of the proposed transaction, including, if required by federal or state antitrust authorities, promptly taking all steps to secure government antitrust clearance, including cooperating in good faith with any government investigation including the prompt production of documents and information demanded by a second request for documents and of witnesses if requested.
9.2. Additional Approvals. AstraZeneca and Hutchison shall cooperate and use respectively all reasonable efforts to make all other registrations, filings and applications, to give all notices and to obtain as soon as practicable all governmental or other consents, transfers, approvals, orders, qualifications authorizations, permits and waivers, if any, and to do all other things necessary or desirable for the consummation of the transactions as contemplated hereby. Neither Party shall be required, however, to divest or out-license products or assets or materially change its business if doing so is a condition of obtaining approval of the transactions contemplated by this Agreement.
9.3. Termination. If a report is required to be filed under any antitrust statute, either Party may, before the Effective Date, terminate this Agreement by written notice to the other Party, if, within [**] after the report is filed, approval of the transactions contemplated by this Agreement under such antitrust statute has not been obtained or the notice and waiting period, as may be extended, under such antitrust statute has not expired without adverse action regarding this Agreement or the transactions contemplated hereby. If this Agreement is terminated pursuant to this Section 9.3, then, notwithstanding any provision in this Agreement to the contrary, neither Party shall have any further obligation to the other Party with respect to the subject matter of this Agreement except for the obligations set forth in Section 6.1, which obligations shall survive any termination of this Agreement; provided that each Party shall within ten (10) days of such termination promptly refund to the other Party in full all amounts paid by such Party to the other Party in connection with this Agreement.
10. TERM AND TERMINATION.
10.1. Term. The term of this Agreement shall commence on the Effective Date and, unless earlier terminated as provided in this Section 10 shall continue in full force and effect on a country-by-country basis as long as any Collaboration Product is being Developed or Commercialized for use in the Field in the Territory (the Term )
10.2. Termination for Convenience; Termination by Mutual Agreement. AstraZeneca may terminate this Agreement in its entirety for any reason or no reason upon providing one hundred eighty (180) days prior written notice to Hutchison. Additionally, the Parties may terminate this Agreement by mutual written agreement.
10.3. Termination for Cause.
10.3.1. Termination for Material Breach . In the event that a Party commits a material breach of its obligations under this Agreement that is not cured within sixty (60) days (or such other time period as mutually agreed by the Parties) after such Party receives written notice from the non-breaching Party, which notice shall specify the nature of the breach and demand its
cure, the non-breaching Party may terminate this Agreement upon written notice to the breaching Party; provided , however , that a breach of this Agreement by AstraZeneca that relates solely to a country that is not a Major Market Country shall give Hutchison a termination right only as to such country (any such termination, a Country-Specific Termination ). Notwithstanding the foregoing, if either Party is alleged to be in material breach and disputes such termination through the dispute resolution procedures set forth in this Agreement, then the other Partys right to terminate this Agreement shall be suspended for so long as such dispute resolution procedures are being pursued by the allegedly breaching Party in good faith and, if it is finally and conclusively determined that the allegedly breaching Party is in material breach, then the breaching Party shall have the right to cure such material breach after such determination within the cure period provided above in this Section 10.3.1 .
10.3.2. Termination for Bankruptcy . This Agreement may be terminated by written notice by either Party at any time during the term of this Agreement if the other Party shall file in any court or Agency, pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of that Party or of its assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed within sixty (60) days after the filing thereof, or if the other Party shall propose or be a Party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of its creditors.
10.4. Effect of Termination.
10.4.1. Effects of Termination for Convenience . If this Agreement is terminated for convenience pursuant to Section 10.2, the following provisions shall apply:
(a) Nothing in this Agreement shall be construed as prohibiting the Hutchison from Developing, Manufacturing and Commercializing a Collaboration Compound and the Collaboration Product in the Field in the Territory;
(b) All licenses granted by Hutchison to AstraZeneca hereunder shall automatically terminate;
(c) AstraZeneca shall, and hereby does, assign to Hutchison all right, title and interest in and to: (i) all Regulatory Submissions and Regulatory Approvals Controlled by AstraZeneca or any Affiliate pertaining to Collaboration Compounds, Collaboration Products and Diagnostic Products in the Field in the Territory and (ii) all of AstraZenecas interest in any copyrights to the extent necessary or useful for Commercializing the Collaboration Product;
(d) If, at the time AstraZeneca terminates the Agreement, a Collaboration Product is then being sold using an AstraZeneca-owned Trademark, AstraZeneca shall, assign all of AstraZenecas interest in any Trademark (including the goodwill symbolized by such Trademark), on commercially reasonable terms to be mutually agreed upon by the Parties;
(e) AstraZeneca shall grant, and shall be deemed to grant, to Hutchison and its Sublicensees a Right of Reference to all data generated in any Clinical Trials undertaken by AstraZeneca , its Affiliates or Sublicensees in accordance with this Agreement (including all such Regulatory Submissions, Regulatory Approvals and Clinical Trial data related to any Diagnostic Product and any Combination Collaboration Products in which the other active ingredients are non-proprietary), and AstraZeneca shall provide a signed statement to this effect, if requested by Hutchison , in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Applicable Law recognized outside of the United States);
(f) AstraZeneca shall, and hereby does, grant to Hutchison a perpetual, royalty-free, irrevocable, non-exclusive license in the Territory to use the data generated in Clinical Trials undertaken by AstraZeneca , its Affiliates or Sublicensees hereunder (including all such Regulatory Submissions, Regulatory Approvals and Clinical Trial data related to any Combination Collaboration Products ) for the Development and Commercialization of Collaboration Compounds, Collaboration Products and Diagnostic Products in the Field in the Territory;
(g) All licenses granted to Hutchison hereunder shall continue, and AstraZeneca shall, and hereby does, grant to Hutchison an exclusive (even as to AstraZeneca) license in the Territory (with the right to sublicense on terms consistent with Section 2.5) (i) to practice any invention claimed in the AstraZeneca Patent Rights or Joint Patent Rights, (ii) to practice the AstraZeneca Know-How and Joint Know-How and (iii) to practice any other Patent Right or Know Controlled by AstraZeneca on the effective date of termination that arose before the effective date of termination and was either in use by AstraZeneca or was actively being considered for use in connection with the Development, Manufacture or Commercialization of any Collaboration Compound, Collaboration Product or Diagnostic Product, in each case ((i) (iii)), solely to the extent necessary to Develop, Manufacture and Commercialize a Collaboration Compound, Collaboration Product or Diagnostic Product, as applicable, in the Field in the Territory;
(h) AstraZeneca shall reasonably cooperate with Hutchison to assure a smooth transition, at Hutchisons expense, of any Clinical Trials in progress related to a Collaboration Compound or Collaboration Product in the Field, which Hutchison determines to continue in compliance with Applicable Laws and ethical guidelines applicable to the transfer or termination of any such Clinical Trials. In the event that Hutchison informs AstraZeneca that it does not intend to continue specific Development activities then in progress, costs incurred in closing out such activities shall be borne by AstraZeneca ;
(i) Until termination is effective, each Party shall continue to perform its obligations under the Development Plan (if still in effect) and shall pay all costs allocated to it in accordance with this Agreement, including the Development Budget (if still in effect), except with respect to activities that the
Hutchison elects to discontinue;
(j) At Hutchisons request, Hutchison may purchase, [**], all of the inventory of bulk or finished Collaboration Products held by AstraZeneca as of the date of termination (including raw materials, intermediates and finished, unfinished, or partially finished goods). Hutchison shall notify AstraZeneca within ten (10) days after the date of termination whether Hutchison wishes to purchase such inventory. In the event Hutchison does not purchase such inventory, then AstraZeneca and its Affiliates shall be permitted to sell such inventory, provided that such sales occur within six (6) months after termination, and provided further that AstraZeneca shall remain obligated to pay, and report to Hutchison on, Net Sales of such inventory; and
(k) At Hutchisons request, AstraZeneca shall use Commercially Reasonable Efforts to assign to Hutchison to the extent assignment is permitted by such agreements and provided that AstraZeneca is not required to pay any consideration or commence litigation in order to effect an assignment of any such agreement any Third Party agreements then in effect for the Manufacture of Collaboration Compound or Collaboration Product.
10.4.2. Effects of Termination for Material Breach .
(a) If this Agreement is terminated by Hutchison pursuant to Section 6.4.3 or 10.3, all licenses granted by Hutchison to AstraZeneca shall automatically terminate. Without limiting the foregoing, in the event this Agreement is terminated by Hutchison for a material breach of AstraZeneca pursuant to Section 6.4.3 or 10.3.1 , the effects of termination set forth in Section 10.4.1 shall apply; provided , however , that in the event of a Country-Specific Termination pursuant to Section 10.3.1, such effects of termination shall apply only with respect to the applicable country.
(b) In the event that AstraZeneca has the right to terminate this Agreement pursuant to Section 10.3.1, AstraZeneca may elect to either (x) terminate this Agreement in its entirety pursuant to Section 10.3.1 or (y) elect, as its sole and exclusive remedy with respect to such breach, to forego its right to terminate this Agreement pursuant to Section 10.3.1, in which case the provisions of clauses (i) (iii) below shall apply.
(i) AstraZenecas sole and exclusive remedy with respect to such breach shall be to offset from amounts due under Sections 5.2 and 5.3 the amount of any agreed-upon or proven damages ( Damages ).
(ii) Pending any agreement between the Parties on the amount of the Damages or a final, non-appealable judgment in a court of competent jurisdiction as to the amount of the Damages ( Final Resolution ), AstraZeneca shall set up
an escrow account into which it shall pay, as they become due, all milestones and royalty payments owed to Hutchison under Section 5.2 or 5.3.
(iii) Upon Final Resolution, any Damages owed to AstraZeneca in respect of the applicable breach shall be deducted by AstraZeneca from amounts paid into such escrow account. In the event the amounts contained in such escrow account exceed the Damages, the amounts remaining in such escrow account shall be released to Hutchison no later than five (5) Business Days after Final Resolution. In the event the amounts contained in such escrow account are insufficient to cover the Damages, the balance of any such amounts may be deducted from the next applicable payment owed by AstraZeneca to Hutchison under Section 5.2 or 5.3 and may be carried forward until fully exhausted.
10.5. Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by Hutchison and AstraZeneca are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy Code, licenses of rights to intellectual property as defined under Section 101 of the United States Bankruptcy Code. The Parties agree that each Party, as licensee of certain rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the United States Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party under the United States Bankruptcy Code, the other Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) any intellectual property licensed to such other Party and all embodiments of such intellectual property, which, if not already in such other Partys possession, shall be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon such other Partys written request therefor, unless the bankrupt Party elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by the bankrupt Party upon written request therefor by the other Party.
10.6. Survival of Certain Obligations . Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing before such expiration or termination. The provisions of this Agreement that must, by their nature, survive expiration or termination of this Agreement to give effect to their intent, shall so survive, including Sections 2.4, 2.6, 6, 9 and 11 Any expiration or early termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement before termination.
11. PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE.
11.1. Indemnification by Hutchison . Hutchison shall indemnify, defend and hold harmless AstraZeneca, its Affiliates, and each of its and their respective employees, officers, directors, agents and Sublicensees (each, a AstraZeneca Indemnified Party )
from and against any and all losses, damages, liabilities, settlements, penalties, fines and expenses (including reasonable attorneys fees and expenses) (collectively, Liability ) that the AstraZeneca Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of:
(a) any Hutchison representation or warranty set forth herein being untrue in any material respect when made or any material breach by Hutchison of any of its covenants or obligations hereunder; or
(b) the gross negligence or willful misconduct by or of Hutchison, its Affiliates and their respective officers, directors, agents and Sublicensees in performing any of their obligations under this Agreement; or
(c) Hutchisons or its Affiliates Development of a Collaboration Compound; or
except in each case, to the extent caused by the gross negligence or willful misconduct of AstraZeneca or any AstraZeneca Indemnified Party, or by breach of this Agreement by AstraZeneca.
11.2. Indemnification by AstraZeneca. AstraZeneca shall indemnify, defend and hold harmless Hutchison, its Affiliates, and each of its and their respective employees, officers, directors, agents and Sublicensees (each, a Hutchison Indemnified Party ) from and against any and all Liabilities that the Hutchison Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of:
(a) any AstraZeneca representation or warranty set forth herein being untrue in any material respect when made or a material breach by AstraZeneca of any of its covenants or obligations hereunder; or
(b) the gross negligence or willful misconduct by or of AstraZeneca, its Affiliates and their respective officers, directors, agents and Sublicensees in performing any of their obligations under this Agreement; or
(c) AstraZenecas Development, Manufacture or Commercialization of a Collaboration Compound or Collaboration Product;
except in each case, to the extent caused by the gross negligence or willful misconduct of Hutchison or any Hutchison Indemnified Party, or by breach of this Agreement by Hutchison.
11.3. Procedure . Each Party shall notify the other in the event it becomes aware of a claim for which indemnification may be sought hereunder or for which Liability is shared pursuant to this Section 11. In case any proceeding (including any governmental investigation) shall be instituted involving any Party in respect of which indemnity may be sought pursuant to this Section 11, such Party (the Indemnified Party ) shall provide the other Party (the Indemnifying Party ) with prompt written notice of such proceeding (the Indemnification Claim Notice ). Promptly after the Indemnifying Party receives the Indemnification Claim Notice, the Indemnifying Party and Indemnified Party shall meet to
discuss how to respond to any claims that are the subject matter of such proceeding. At its option, the Indemnifying Party may assume the defense of any Third Party claim subject to indemnification as provided for in this Section 11.3 by giving written notice to the Indemnified Party within thirty (30) days (or until such time provided in any applicable extension to appropriately answer any complaint, if any, but no longer than seventy (70) days, provided that the Indemnified Party makes all reasonable efforts to obtain any such extension) after the Indemnifying Partys receipt of an Indemnification Claim Notice, provided that (a) the claim solely seeks monetary damages and (b) the Indemnifying Party expressly agrees in writing that as between the Indemnifying Party and the Indemnified Party, the Indemnifying Party shall be solely obligated to satisfy and discharge the claim in full (the matters described in (a) and (b), the Litigation Conditions ). The Indemnifying Party may, at any time, assume all such defense if the Litigation Conditions are not satisfied at any time. Upon assuming the defense of a Third Party claim in accordance with this Section 11.3, the Indemnifying Party shall be entitled to appoint lead counsel in the defense of the Third Party claim. Should the Indemnifying Party assume and continue the defense of a Third Party claim, except as otherwise set forth in this Section 11.3, the Indemnifying Party will not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party claim. Without limiting this Section 11.3, any Indemnified Party will be entitled to participate in, but not control, the defense of a Third Party claim for which it has sought indemnification hereunder and to employ counsel of its choice for such purpose; provided , however , that such employment will be at the Indemnified Partys own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing, (ii) the Indemnifying Party has failed to assume and actively further the defense and employ counsel in accordance with this Section 11.3 (in which case the Indemnified Party will control the defense) or (iii) the Indemnifying Party no longer satisfies the Litigation Conditions. With respect to any Liability relating solely to the payment of money damages in connection with a Third Party claim that will not result in the Indemnified Partys becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnified Party in any manner, and as to which the Indemnifying Party will have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, and subject to the Litigation Conditions being satisfied, the Indemnifying Party will have the sole right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Liability, on such terms as the Indemnifying Party, in its reasonable discretion, will deem appropriate (provided that such terms shall include a complete and unconditional release of the Indemnified Party from all liability with respect thereto), and will transfer to the Indemnified Party all amounts which said Indemnified Party will be liable to pay prior to the time of the entry of judgment. With respect to all other Liabilities in connection with Third Party claims, where the Indemnifying Party has assumed the defense of the Third Party claim in accordance with this Section 11.3, the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Liability provided that it obtains the prior written consent of the Indemnified Party (which consent will be at the Indemnified Partys reasonable discretion). The Indemnifying Party that has assumed the defense of the Third Party claim in accordance with this Section 11.3 will not be liable for any settlement or other disposition of a Liability by an Indemnified Party (but in no event to include any court judgment or judicial or administrative order or
disposition) that is reached without the written consent of such Indemnifying Party. No Indemnified Party will admit any liability with respect to, or settle, compromise or discharge, any Third Party claim without first offering to the Indemnifying Party the opportunity to assume the defense of the Third Party claim in accordance with this Section 11.3. If the Indemnifying Party chooses to defend or prosecute any Third Party claim, the Indemnified Party will cooperate in the defense or prosecution thereof and will 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 with such Third Party claim. Such cooperation will include access during normal business hours afforded to 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 employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.
11.4. Insurance . The Parties shall maintain insurance with creditworthy insurance companies or self insure in accordance with Applicable Law against such risks and in such amounts as are usually maintained or insured against by other companies of established repute engaged in the same or a similar business.
11.5. Liability Limitations.
11.5.1. No Consequential Damages . EXCEPT WITH RESPECT TO ANY BREACH OF SECTION 6.1 (CONFIDENTIALITY), IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES UNDER THIS AGREEMENT, EXCEPT TO THE EXTENT THE DAMAGES RESULT FROM A PARTYS FRAUD OR WILLFUL MISCONDUCT OR ARE PAYABLE IN CONNECTION WITH A PARTYS INDEMNIFICATION OBLIGATIONS UNDER THIS SECTION 11 FOR LIABILITY OWED TO THIRD PARTIES.
11.5.2. S cope of Hutchisons Liability . In no event shall Hutchisons Liability under this Agreement exceed, [**] (the Liability Cap ); provided , however , that such Liability Cap shall not apply to any Liability based on or arising out of any death or personal injury to a Third Party resulting from any negligence of Hutchison, its Affiliates or Sublicensees.
12. MISCELLANEOUS.
12.1. Governing Law, Jurisdiction; Dispute Resolution.
12.1.1. Governing Law . The interpretation and construction of this Agreement shall be governed by the laws of England, and the Parties hereby submit to the non-exclusive jurisdiction of the English courts.
12.1.2. Dispute Resolution . In the event of a dispute arising out of or relating to
this Agreement either Party shall provide written notice of the dispute to the other, in which event the dispute shall be referred to the executive officers designated below or their successors, for attempted resolution by good faith negotiations within [**] after such notice is received. Said designated officers are initially as follows:
For Hutchison: Chief Executive Officer, Hutchison MediPharma Limited
For AstraZeneca: its Executive Vice President, Innovative Medicines or his designee
In the event the designated executive officers do not resolve such dispute within the allotted [**], either Party may, after the expiration of the [**] period, seek to resolve the dispute through reference to the courts in accordance with Section 12.1.1. Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, shall not be deemed a dispute which may be referred for resolution by the Parties under this Section 12.1.2.
12.1.3. Agent for Service .
(a) To the extent that any injunctive or other Proceedings (as defined below) are sought in the court of England, the Parties hereby irrevocably agrees that any Service Document (as defined below) may be sufficiently and effectively served on it in connection with Proceedings by service on its agent, provided that if a replacement agent has been appointed and notified to the other party pursuant to Section 12.1.3(d), then by service on such replacement agent.
(b) Any Service Document served pursuant to Section 12.1.3(a) shall be marked for the attention of:
If to Hutchison:
Address: c/o Hutchison Whampoa Agents (UK) Limited
Hutchison House
5 Hester Road
Battersea
London SW11 4AN
United Kingdom
Fax no: +44 20 7350 5791
Attention: The Company Secretary
If to AstraZeneca:
Address: AstraZeneca UK Limited
2 Kingdom Street
London W2 6BD
Fax no: +44 20 7604 8060
Attention: The Company Secretary
(c) Any Service Document addressed in accordance with Section 12.1.3(b) shall be deemed to have been duly served if: (i) left at the specified address at the time it is left; (ii) sent by first class post, two working days after the day of posting; or (iii) sent by facsimile transmission, when the electronic acknowledgment is received by the sender.
(d) If either the agent of the Parties referred to in Section 12.1.3(b) (or any replacement agent appointed pursuant to this sub-section) at any time ceases for any reason to act as such, the Parties (as the case may be) shall appoint a replacement agent to accept service having an address for service in the United Kingdom and shall notify the other party of the name and address of the replacement agent.
(e) In this Section 12.1.3: (i) Proceedings means any proceeding, action arising out of or in connection with this Agreement, as contemplated by Clause 12.1.3(a); and (ii) Service Document means a writ, summons, order, judgment or other process issued out of the courts of England in connection with any Proceedings.
(f) A person who is not a party to this Agreement shall have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of its terms.
12.2. Force Majeure . No liability shall result from, and no right to terminate shall arise, in whole or in part, based upon any delay in performance or non-performance, in whole or in part, by either of the Parties to this Agreement to the extent that such delay or non-performance is caused by an event of Force Majeure. Force Majeure means an event that is beyond a non-performing Partys reasonable control, including an act of God, act of the other Party, strike, lock-out or other industrial/labor dispute not involving the non-performing Partys own employees, war, riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster or compliance with any law or governmental order, rule, regulation or direction, whether or not it is later held to be invalid or inapplicable. The Force Majeure Party shall within ten (10) days of the occurrence of the Force Majeure event, give written notice to the other Party stating the nature of the Force Majeure event, its anticipated duration and any action being taken to avoid or minimize its effect. Any suspension of performance shall be of no greater scope and of no longer duration than is reasonably required and the Force Majeure Party shall use reasonable effort to remedy its inability to perform; provided, however, if the suspension of performance continues or is anticipated to continue for thirty (30) days after the date of the occurrence, the unaffected Party shall have the right but not the obligation to perform on behalf of the Force Majeure Party for a period of such Force Majeure and such additional period as may be reasonably required to assure a smooth and uninterrupted transition of such activities. If such failure to perform would constitute a material breach of this Agreement in the absence of such event of Force Majeure, and continues for six (6) months from the date of the occurrence and the Parties are not able to agree on appropriate amendments within such
period, such other Party shall have the right, notwithstanding the first sentence of this Section 12.3, to terminate this Agreement immediately by written notice to the Force Majeure Party, in which case neither Party shall have any liability to the other except for those rights and liabilities that accrued prior to the date of termination.
12.3. Waiver and Non-Exclusion of Remedies. A Partys 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
12.4. Notices.
12.4.1. Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement shall be in writing, shall refer specifically to this Agreement and shall be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 12.4.2 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 Section 12.4.1. Such Notice shall be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second business day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 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.
12.4.2. Address for Notice .
Hutchison:
Hutchison MediPharma Limited
Building 4, 720 Cailun Road
Zhangjiang High Tech Park
Shanghai, China 201203
Attn: Chief Executive Officer, Hutchison MediPharma Limited
Fax: 86-21-50793900
With a copy to:
Hutchison Whampoa Limited
22/F Hutchison House
10 Harcourt Road
Central
Hong Kong
Attn: Head Group General Counsel & Company Secretary
Fax: +852 2128 1778
AstraZeneca:
AstraZeneca AB
S-151 85 Södertälje
Sweden
Attn: The Company Secretary
Fax: +46 8 553 288 12
With a copy to:
AstraZeneca UK Limited
Mereside
Alderley Park
Macclesfield
Cheshire SK10 4TF
United Kingdom
Attn: Vice President, Oncology, SPBD
12.5. Entire Agreement. This Agreement, constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter hereof. 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 or 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.
12.6. Amendment. Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of both Parties.
12.7. Assignment. Neither Party may assign its rights or delegate its obligations under this Agreement, in whole or in part without the prior written consent of the other Party, except that each Party shall always have the right, without such consent, (a) to perform any or all of its obligations and exercise any or all of its rights under this Agreement through any of its Affiliates and, (b) on written notice to the other Party, assign any or all of its rights and delegate or subcontract any or all of its obligations hereunder to (i) any of its Affiliates, (ii) a successor of all or substantially all of the business of such Party, whether by way of merger, sale of stock, sale of assets or other transaction (or series of transactions) or (iii) a successor of that portion of a Partys business to which this Agreement pertains. Any permitted successor or assignee of rights or obligations hereunder shall, in a writing to the other Party, expressly assume performance of such rights or obligations. Notwithstanding the foregoing, each Party shall remain responsible for any failure to perform on the part of any such Affiliates. Any attempted assignment or delegation in violation of this Section shall be void.
12.8. No Benefit to Others. 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 this Agreement.
12.9. 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.
12.10. Severability. 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. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and shall not form part of this Agreement. To the fullest extent permitted by applicable law and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement shall remain in full force and effect and the Parties will 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.
12.11. Further Assurance. Each Party shall perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
12.12. Publicity. Notwithstanding Section 6 1.6., it is understood that the Parties will issue a press release announcing the execution of this Agreement in substantially the form attached hereto Schedule 12.12. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of any subsequent press releases relating to the Agreement or the activity hereunder prior to the issuance thereof, provided that a Party may not unreasonably withhold consent to such releases, and that either Party may issue such press releases as it determines, based on advice of counsel, are reasonably necessary to comply with laws or regulations or for appropriate market disclosure or which are consistent with information disclosed in prior releases properly made hereunder.
12.13. 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 or any of its Affiliates shall be employees of such Party or its Affiliates and not of the other Party or such other Partys Affiliates and all costs and obligations incurred by reason of any such employment shall be for the account and expense of such Party or its Affiliates, as applicable.
12.14. Subcontracting. Hutchison may, in its sole discretion, use one or more Affiliates or Third Party contractors to perform any or all of its obligations under this Agreement, provided that Hutchison shall remain responsible for its obligations under the Agreement and shall be responsible for the performance of each such Affiliate and Third Party subcontractor.
12.15. 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. English shall be the official language of this Agreement and all communications between the Parties shall be conducted in that language.
12.16. Construction. Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word or has the inclusive meaning represented by the phrase and/or. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Schedules and Exhibits or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms including, include(s), such as, and for example as used in this Agreement mean including the generality of any description preceding such term and shall be deemed to be followed by without limitation.
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Agreement to be effective as of the Effective Date.
ASTRAZENECA AB (publ) |
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记黄埔医药(上海)有限公司
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[SIGNATURE PAGE TO LICENSE AND COLLABORATION AGREEMENT]
Schedule 1.11
Back-Up Compounds
HUTCHISON
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Schedule 1.19
Collaboration Compound
HUTCHISON COMPOUND CODE |
HMPL-504 |
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GENERIC NAME |
Volitinib |
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Schedule 1.32
Development Plan and Development Budget
[**]
Schedule 1.49
Hutchison Patent Rights
The following are the pending patent applications related to the Collaboration Compound and the Back-Up Compounds.
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Schedule 12.12
Joint Regulatory News Service Press Release
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HUTCHISON CHINA MEDITECH LTD |
AstraZeneca PLC (AstraZeneca) |
Hutchison China Medi Tech Limited |
(LSE: AZN) |
(Chi-Med) (AIM: HCM) |
ASTRAZENECA AND CHI-MED ENTER INTO GLOBAL
COLLABORATION TO CO-DEVELOP AND COMMERCIALISE
NOVEL CANCER THERAPY
London, Wednesday, 21 December 2011: AstraZeneca and Hutchison MediPharma Limited (HMP), an R&D company majority owned by Chi-Med, today announce that they have entered into a global licensing, co-development, and commercialisation agreement for Volitinib (HMPL-504), a novel targeted therapy and a highly selective inhibitor of the c-Met receptor tyrosine kinase for the treatment of cancer. Volitinib, which will imminently enter Phase I testing, has been discovered and developed in China by HMP.
Under the terms of the agreement, development costs for Volitinib in China will be shared between HMP and AstraZeneca, with HMP continuing to lead the development in China. AstraZeneca will lead and pay for the development of Volitinib for the rest of the world. An initial cash payment of US$20 million is payable by AstraZeneca to HMP upon the signing of the agreement. In addition, HMP will receive up to US$120 million contingent upon the successful achievement of clinical development and first sale milestones. The agreement also contains possible significant future commercial sale milestones and up to double-digit percentage royalties on net sales. This collaboration further underscores AstraZenecas goal to provide innovative medicines for unmet medical needs for patients in China.
Susan Galbraith, Head of Oncology Innovative Medicines, AstraZeneca said: Volitinib represents a highly attractive global opportunity for AstraZeneca as we seek to develop and commercialise novel, targeted cancer therapies. This collaboration with HMP represents our commitment to China and brings together two groups with highly complementary capabilities.
Christian Hogg, Chief Executive Officer of Chi-Med said: We are very much looking forward to collaborating with AstraZeneca around Volitinib. Our collaboration will support the development and commercialisation of this novel oncology innovation, discovered in China, to the global market on an accelerated basis, something we could not have done alone.
Ends
· Enquiries
· Notes to Editors
· About HMP
HMP is a novel drug R&D company focusing on discovering, developing and commercialising innovative therapeutics in oncology and autoimmune diseases. With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America, Europe, Australia and Greater China.
HMP is majority owned by Chi-Med. For more information please visit: www.hmplglobal.com
· About Chi-Med
Chi-Med is the holding company of a healthcare group based primarily in China and was listed on the Alternative Investment Market of the London Stock Exchange in May 2006. It is focused on researching, developing, manufacturing and selling pharmaceuticals and health oriented consumer products.
Chi-Med is majority owned by Hutchison Whampoa Limited, an international company listed on the Main Board of The Stock Exchange of Hong Kong Limited. For more information please visit: www.chi-med.com
· About the c-Met Signal pathway
The c-Met (also known as HGFR) signalling pathway has specific roles particularly in normal mammalian growth and development, however this pathway has been shown to function abnormally in a range of different cancers. Volitinib is a potent and highly selective c-Met
inhibitor, which has been demonstrated to inhibit the growth of tumours in a series of pre-clinical disease models, especially for those tumours with aberrant c-Met signalling such as gene amplification or c-Met over-expression. In addition these biomarkers provide the potential to explore patient selection strategies in later stage clinical trials.
· About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com
· About AstraZeneca in China
AstraZeneca is one the leading biopharmaceutical companies in China providing innovative, high quality medicines for some of the most serious disease areas and therapies, including cardiovascular, gastrointestinal, respiratory, neurological, cancer, inflammation and anesthesia.
AstraZenecas turnover in China was over $1 billion in 2010. The company employs approximately 5,000 staff working in manufacturing, sales and marketing, clinical research and new product development at the companys headquarters in Shanghai and across sites in mainland China and Hong Kong.
The companys research and development facilities include the AstraZeneca Innovation Centre China (ICC), which started operations in 2007. Today, ICC is a full-fledged discovery centre focused on delivering candidate drugs and ultimately Proof of Concepts (POCs) and medicines, with a focus on diseases that are more prevalent in Asian patients. In January 2011, the company also opened a global Clinical Operational Hub in Shanghai - one of five such hubs globally.
THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
AMENDED AND RESTATED
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
between
HUTCHISON MEDIPHARMA LIMITED
and
ELI LILLY TRADING (SHANGHAI) COMPANY LIMITED
and
HUTCHISON CHINA MEDITECH LIMITED
AMENDED AND RESTATED
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
between
HUTCHISON MEDIPHARMA LIMITED
and
HUTCHISON CHINA MEDITECH LIMITED
EXCLUSIVE LICENSE AND COLLABORATION AGREEMENT
This Agreement (the Agreement ), effective as of 8 th October 2013 (the Effective Date ), is entered into by and among (i) Hutchison MediPharma Limited, a Chinese company, organized and existing under the laws of the Peoples Republic of China, having a place of business at Building 4, 720 Cai Lun Road, ZJ Hi-Tech Park, Shanghai, PRC ( Hutchison ) and (ii) Eli Lilly and Company, an U.S.A. company, organized and existing under the laws of the State of Indiana, having a place of business at Lilly Corporate Center, Indianapolis, Indiana 46285 U.S.A. ( Lilly ), and (iii) solely for the purposes of Articles 7.11(a), 7.11(b) and 7.11(c), Hutchison China MediTech Limited, a company organized and existing under the laws of the Cayman Islands with its principal offices at PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands (the Hutchison Guarantor ). Hutchison and Lilly may be referred to herein individually as a Party or collectively as the Parties. Reference to a Party shall be deemed to include that Partys Affiliates.
Recitals:
A. Hutchison is the owner of a molecule HMPL-013 and is developing it for the Chinese market as a pharmaceutical product useful in the treatment of cancer.
B. Lilly is a U.S.A. pharmaceutical company having expertise in the discovery, development, manufacturing and commercialization of innovative human pharmaceutical products, including cancer products.
C. Lilly and Hutchison desire to enter into a collaboration under which Lilly would obtain exclusive rights in the Field in the Territory to Hutchisons developmental stage pharmaceutical product, the cancer compound known as HMPL-013, including any back-up compounds that Hutchison and/or Lilly may develop under the terms and conditions set forth in this Agreement.
D. Hutchison, Hutchison Guarantor and Eli Lilly and Company entered into a license and collaboration agreement effective from 8 October 2013 (the Original Agreement ) which was assigned to Lilly with effect from the same date. The parties now hereby agree with the signing of this Agreement to terminate the Original Agreement and replace it in its entirety with this Agreement.
In consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
Agreement:
1. DEFINITIONS .
Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
1.1 Adverse Event means 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. Also, known as an adverse experience.
1.2 Affiliate means with respect to any Party, any person or entity controlling, controlled by or under common control with such Party. For purposes of this Article 1.2, control shall mean (a) in the case of a corporate entity, direct or indirect ownership of fifty percent (50%) or more of the stock or shares having the right to vote for the election of directors of such corporate entity and (b) in the case of an entity that is not a corporate entity, the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such entity, whether through the ownership of voting securities, by contract or otherwise.
1.3 Agreement shall have the meaning set forth in the introduction to this agreement.
1.4 Applicable Laws means all statutes, ordinances, regulations, rules or orders of any kind whatsoever of any Governmental Authority that may be in effect from time to time and applicable to the activities contemplated by this Agreement.
1.5 Audit shall have the meaning set forth in Article 5.2(d).
1.6 Business Day means a day other than a Saturday, Sunday, or a bank or other public holiday in Shanghai, China, or in Indianapolis, Indiana.
1.7 Calendar Quarter means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.8 Calendar Year means the respective periods of twelve (12) months commencing on January 1 and ending on December 31.
1.9 Cause shall have the meaning set forth in Article 5.2(d).
1.10 cGMP means current good manufacturing practices as promulgated for example under the United States Federal Food, Drug, and Cosmetic Act and similar requirements of jurisdictions outside the United States applicable to Manufacture of Clinical Materials or a Product.
1.11 Change of Control shall have the meaning set forth in Article 15.2.
1.12 Clinical Material(s) means Product formulated in accordance with the Specifications and Applicable Laws (a) for preclinical activities, and (b) for administration to subjects in clinical trials, as applicable.
1.13 Combination Product(s) means any combination of Product and one or more additional active pharmaceutical ingredients, for example in a single delivery device such as a pre-filled pen, dual chamber needle or in a fixed dose combination.
1.14 Commercialization or Commercialize means activities relating specifically to the pre-launch, launch, promotion, marketing, sales force recruitment, pricing determination, sale and distribution of a pharmaceutical product and post-launch medical activities, including: (a) manufacturing and distribution for commercial sale, (b) strategic marketing, sales force detailing, advertising, and market and product support; (c) medical education and liaison and any phase IV clinical trials; (d) all customer support and product distribution, invoicing and sales activities; (e) all post-approval regulatory activities, including those necessary to maintain Regulatory Approvals; and (f) target product profile, pricing, formulary and reimbursement related activities including pricing and reimbursement approvals.
1.15 Commercially Reasonable Efforts means with respect to the efforts to be expended by a Party with respect to any objective under this Agreement, the efforts to accomplish such objective as a similarly situated party would normally use to accomplish a similar objective of a similarly situated party under similar circumstances, it being understood and agreed that with respect to the Development or Commercialization of a Product such efforts shall be similar to those efforts and resources commonly used by a similarly situated party for a similar biological or pharmaceutical product owned by it 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 taking into account efficacy, safety, approved labeling, profitability, the competitiveness of alternative products in the marketplace, the exclusivity of the product in view of its patent protection, patent life and other proprietary position of the product, and the likelihood of Regulatory Approval given the regulatory structure involved, provided such efforts are substantially and materially consistent with industry practices and standards .
1.16 Compliance shall mean the adherence by the Parties in all material respects to all Applicable Laws and Party Specific Regulations, in each case with respect to the activities to be conducted under this Agreement.
1.17 Confidential Information means all confidential information of the Disclosing Party or its Affiliates, regardless of its form or medium as provided to the Receiving Party or its Affiliates in connection with this Agreement; provided that, Confidential Information shall not include any information that the Receiving Party can show by competent evidence: (i) is already
known to the Receiving Party at the time it is disclosed to the Receiving Party by the Disclosing Party; (ii) is or becomes generally known to the public through no act or omission of the Receiving Party in violation of the terms of this Agreement; (iii) has been lawfully received by the Receiving Party from a Third Party without restriction on its disclosure and without, to the knowledge of the Receiving Party, a breach by such Third Party of an obligation of confidentiality to the Disclosing Party; or (iv) has been independently developed by the Receiving Party without use of or reference to the Confidential Information of the Disclosing Party.
1.18 Control , Controls or Controlled by means (except as used in Article 1.1, above), with respect to any item of or right under Patents or Know-How, the ability of a Party (whether through ownership or license or other right), other than pursuant to this Agreement, to grant access to, license or sublicense such item or right without violating the terms of any agreement or other arrangement with any Third Party existing at the time such Party would be required hereunder to grant the other Party such access or license or sublicense.
1.19 Conversion Rate shall mean the conversion rate of United States dollars (US$) to Renminbi (RMB) of US$1 to RMB6.15.
1.20 Cost of Goods Sold or COGS means all those costs incurred by the supplier of Product for the acquisition of materials from vendors and Third Party suppliers and conversion of such materials into a final, packaged Product. Such costs include: The landed cost of purchased materials; and conversion costs associated with the Manufacture and testing of such Product, including direct labor and an appropriate allocation of indirect costs (proportional to the actual manufacturing time for any given Product). Examples of indirect costs include maintenance of equipment and facilities, line supervision, and technical support. All the costs and methodologies to be used in allocating indirect costs or support services (including depreciation) shall be determined in a manner consistent with GAAP or IFRS as applicable to a Party. Remediation costs outside of capital depreciation and reasonable and customary sample cost shall not be included in Cost of Goods Sold. If Hutchison uses its site for Manufacturing, such costs shall be consistent with and limited to those commonly incurred by Third Party contract manufacturers.
1.21 Data Exclusivity Period means, with respect to a Product in a country, the period during which the Regulatory Authority responsible for approval or authorization of the sale of drugs confers exclusive marketing rights or data exclusivity rights to the owner of the regulatory submission materials for such Product in such country, including the prohibition of reference, without the consent of the owner, to the clinical and other data that is contained in such regulatory submission materials.
1.22 Develop or Development or Developing means research, discovery, process development, preparation for drug reimbursement, organizing formulary access and drug distribution, preparation and initiation of medical education and liaison activities and preclinical and clinical drug or biological development activities, including test method development and stability testing, toxicology, formulation, quality assurance/quality control development, statistical analysis, preclinical and clinical studies and regulatory affairs, approval and registration, in each case, of a Product for use in the Field, and to the extent normally undertaken
during the development (as opposed to Commercialization) phase of such Products life cycle. Development shall exclude all Phase IV clinical trials.
1.23 Development Costs means (a) FTE Costs and other costs actually incurred by Hutchison or its Affiliates or Lilly or its Affiliates, as applicable (such Party or Affiliate, the Incurring Party for the purposes of this Article 1.22), that are (i) specifically identifiable or allocable to Development of a Product, (ii) reasonably incurred by the Incurring Party and (iii) that result from activities specifically assigned to the Incurring Party in accordance with this Agreement or the applicable Development Plan; provided that no costs incurred by Lilly or its Affiliates shall be deemed Development Costs unless such costs are incurred in Subsequent Development and are approved in advance by the JSC and (b) the COGS of the clinical supply of Product for Phase II/III clinical trials and Phase III clinical trials, such COGS to be Subsequent Development Costs. Development Costs shall, subject to the preceding sentence, include: (x) amounts paid to Third Parties by the Incurring Party in connection with the conduct of Development and (y) any costs specifically referred to as Development Costs in this Agreement.
1.24 Development Plan shall have the meaning set forth in Article 3.1(a).
1.25 Disclosing Party shall have the meaning set forth in Article 9.1.
1.26 Effective Date shall have the meaning set forth in the introduction in this agreement.
1.27 Electing Party shall have the meaning set forth in Article 0.
1.28 Field means all uses.
1.29 First Commercial Sale means, with respect to any Product, the first sale to a Third Party for end use or consumption of such Product in a country after Regulatory Approval has been granted by the Regulatory Authority of such country.
1.30 Forecast shall have the meaning set forth in Article 5.4.
1.31 FTE Costs means, with respect to any period of time, the FTE Rate multiplied by the number of full-time equivalent employees of Lilly or Hutchison, or their respective Affiliates, working directly on the Development of a Product during such period of time.
1.32 FTE Rate shall mean the FTE Rate set forth in Exhibit B, as amended from time to time by the JSC as a Mutual JSC Matter.
1.33 FTO Submission shall have the meaning set forth in Article 7.1(b).
1.34 Full Data Set shall have the meaning set forth in Article.
1.35 GAAP means U.S. Generally Accepted Accounting Principles as the same may be in effect from time to time, as generally and consistently applied.
1.36 Generic Competition means, with respect to a Product in any country in the Territory, one (1) or more Third Parties have received Regulatory Approval to sell a Generic Product to such Product in such country and such Generic Product(s) is commercially available in such country.
1.37 Generic Product means, on a country-by-country basis, a product (a) independently developed and commercialized by a Third Party and (b) that is approved by the applicable Regulatory Authority for sale in the relevant country for use for the same indication or indications for which a Product has received Regulatory Approval in such country and in reliance on such prior Regulatory Approval of such Product in such country.
1.38 Governmental Authority shall mean any court, commission, authority, department, ministry, official or other instrumentality of, or being vested with public authority under any law of, any country, state or local authority or any political subdivision thereof, or any association of countries.
1.39 Guarantor means the Hutchison Guarantor.
1.40 Hutchison shall have the meaning set forth in the introduction to this Agreement.
1.41 Hutchison Guarantor shall have the meaning set forth in the introduction to this Agreement.
1.42 Hutchison Know-How means any and all Know-How, to the extent Controlled by Hutchison as of the Effective Date or during the Term, that is necessary or reasonably useful in connection with the Development, Commercialization or other use of a Product in the Field in the Territory.
1.43 Hutchison Patents means Patents in the Territory Controlled by Hutchison on the Effective Date or during the Term that contain one or more claims to Products. Hutchison Patents as of the Effective Date are listed on Exhibit A attached hereto.
1.44 IFRS means International Financial Reporting Standards as the same may be in effect from time to time, as generally and consistently applied.
1.45 Initial Development shall have the meaning set forth in Article 3.1(c).
1.46 Initial Indications means (a) 3 rd line colorectal cancer, (b) 3 rd line non-small cell lung cancer and (c) 2 nd line advanced gastric cancer. Each of the Initial Indications shall be an Initial Indication hereunder.
1.47 Initial Product shall have the meaning set forth in Article 1.66(a).
1.48 Internal Compliance Codes means a Partys internal policies and procedures intended to ensure that a Party complies with Applicable Laws, Party Specific Regulations, and such Partys internal ethical, medical and similar standards.
1.49 JSC Co-Chairs shall have the meaning set forth in Article 2.2(a).
1.50 Jointly Owned Patents shall have the meaning set forth in Article 12.2.
1.51 Know-How means (a) any proprietary scientific or technical information, results and data of any type whatsoever, in any tangible or intangible form whatsoever, including databases, safety information, practices, methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill, experience, test data including pharmacological, medicinal chemistry, biological, chemical, biochemical, toxicological and clinical test data, analytical and quality control data, stability data, studies and procedures, and manufacturing process and development information, results and data and (b) any proprietary biological, chemical or physical materials.
1.52 Latent Defects means a defect: (a) which could not reasonably have been discovered upon receipt and inspection of the Product and (b) for which the cause is attributed to the actions or omissions of Hutchison or its Third Party Manufacturer prior to delivery of the Product to Lilly.
1.53 Life Cycle Planning Indications means any indication that is not an Initial Indication for which one or more Parties elect to Develop a Product pursuant to this Agreement
1.54 Lilly shall have the meaning set forth in the introduction in this Agreement.
1.55 Lilly Patent shall have the meaning set forth in Article 12.2.
1.56 Major Unexpected Safety Issue means in Lillys reasonable opinion a material, unexpected and Development-ending failure of a Product in an Initial Indication to meet the safety criteria for such Product in such Initial Indication in Exhibit C .
1.57 Manufacture or Manufacturing or Manufactured means all operations involved in the manufacturing, quality control testing (including in-process, release and stability testing, if applicable), storage, releasing and packaging the Product.
1.58 Manufacturing Authorization means any and all consents or other authorizations or approvals from the China Food and Drug Administration (CFDA) that is necessary for the manufacture of the Product in the Territory, (including the Manufacturing License Approvals), and any supplement, amendment or variation thereof.
1.59 Mutual JSC Matters shall have the meaning set forth in Article 2.2(d).
1.60 Net Sales shall mean, with respect to a Product, the gross amount invoiced by Lilly (including a Lilly Affiliate) or any Sublicensee thereof to unrelated Third Parties (excluding any non-end user Sublicensee), for the Product in the Territory, less:
[**]
[**]
[**]
[**]
[**]
provided that, the deductions taken pursuant to clauses (a) through (e) in this Article 1.55 shall be consistent with the deductions taken by Lilly, its Affiliates or Sublicensees with respect to other similar products to the Product.
Such amounts shall be determined from the books and records of Lilly, its Affiliate or Sublicensee, maintained in accordance with GAAP or, in the case of Sublicensees, such similar accounting principles, consistently applied. Lilly further agrees in determining such amounts, it will use Lillys then current standard procedures and methodology, including Lillys then current standard exchange rate methodology for the translation of foreign currency sales into U.S. Dollars or, in the case of Sublicensees, such similar methodology, consistently applied.
In the event that the Product is sold as part of a Combination Product, the Net Sales of the Product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product (as defined in the standard Net Sales definition) by the fraction, A / (A+B) where A is the weighted average sale price of the Product when sold separately in finished form, and B is the weighted average sale price of the other product(s) sold separately in finished form.
In the event that the weighted average sale price of the Product can be determined but the weighted average sale price of the other product(s) cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the fraction A / C where A is the weighted average sale price of the Product when sold separately in finished form and C is the weighted average sale price of the Combination Product.
In the event that the weighted average sale price of the other product(s) can be determined but the weighted average sale price of the Product cannot be determined, Net Sales for purposes of determining royalty payments shall be calculated by multiplying the Net Sales of the Combination Product by the following formula: one (1) minus B / C where B is the weighted average sale price of the other product(s) when sold separately in finished form and C is the weighted average sale price of the Combination Product.
In the event that the weighted average sale price of both the Product and the other product(s) in the Combination Product cannot be determined, the Net Sales of the Product shall be a percentage of the Net Sales of the Combination Product mutually agreed upon by the Parties in good faith.
1.61 Non-Conformity shall have the meaning set forth in Article 5.6(a).
1.62 Party Specific Regulations means all judgments, decrees, orders or similar decisions issued by any Governmental Authority specific to a Party, and all consent decrees, corporate integrity agreements, or other agreements or undertakings of any kind by a Party with
any Governmental Authority, in each case as the same may be in effect from time to time and applicable to a Partys activities contemplated by this Agreement.
1.63 Patent(s) means (a) all patents and patent applications in any country or supranational jurisdiction and (b) any provisionals, substitutions, divisions, continuations, continuations in part, reissues, renewals, registrations, confirmations, reexaminations, extensions, supplementary protection certificates and the like, of any such patents or patent applications.
1.64 Patent Prosecution means the responsibility and authority for (a) preparing, filing and prosecuting applications (of all types) for any Patent, (b) paying, filing and maintenance fees relating to any Patent, (c) managing any interference, opposition, re-issue, reexamination, revocation, nullification, or cancellation proceeding relating to the foregoing, (d) deciding to abandon Patent(s) and (e) settling any interference, opposition, revocation, nullification or cancellation proceeding.
1.65 Positive POC means the successful achievement by a Product for an Initial Indication of all the criteria for completion of a proof of concept study or trial as set forth for such Product and indication in Exhibit C; provided that, with respect to a Product Developed for the Initial Indication of 3 rd line non-small cell lung cancer, Positive POC shall mean the determination of Lilly pursuant to Article 3.4(a)(ii) to proceed with Development of such Product for such indication following the proof of concept study or trial for such indication.
1.66 Product means any form or dosage of (a) the HMPL-013 molecule (the structure of which is set forth in Exhibit E) or (b) any analogues or derivatives of the HMPL-013 molecule that are claimed by those Hutchison Patents that also claim HMPL-013, in each case that exist as of the Effective Date or are discovered or developed by Hutchison during the Term of this Agreement.
1.67 Quality Agreement shall have the meaning set forth in Article 5.2(c).
1.68 Receiving Party shall have the meaning set forth in Article 9.1(a).
1.69 Regulatory Approval means, with respect to a Product in a country, all approvals from the relevant Regulatory Authority to market and sell such Product in such country (including all applicable pricing and reimbursement approvals required to market and sell such Product in such country, if any).
1.70 Regulatory Authority means the CFDA (China Food and Drug Administration) or any applicable government regulatory authority involved in granting approvals for the conduct of clinical trials or the manufacturing, marketing, reimbursement or pricing of a Product in the Territory.
1.71 Related Party means, with respect to a Party, its Affiliates and Sublicensees.
1.72 Royalty Term shall have the meaning set forth in Article 7.3(b).
1.73 Safety Agreement shall have the meaning set forth in Article 6.3.
1.74 Secretary shall have the meaning set forth in Article 2.3.
1.75 Short Order shall have the meaning set forth in Article 5.4(c).
1.76 Specifications means the specifications for the Product as agreed upon by the Joint Steering Committee.
1.77 Subcontractor shall have the meaning set forth in Article 3.6.
1.78 Sublicensee means a Third Party that is granted a sublicense under the licenses granted to a Party in accordance with this Agreement.
1.79 Subsequent Development means (a) any Development of a Product for an Initial Indication after such Product has achieved Positive POC for such Initial Indication or Lilly has elected to conduct Subsequent Development of a Product for such Initial Indication pursuant to Article 3.4(a)(iii), including the conduct of post-proof of concept studies for such Product for such Initial Indication and (b) all Development of any Product for a Life Cycle Planning Indication that the Parties may approve for Development pursuant to this Agreement.
1.80 Subsequent Development Costs means any Development Costs specifically identifiable or allocable to the Subsequent Development of a Product.
1.81 Term shall have the meaning set forth in Article 13.1.
1.82 Territory means mainland Peoples Republic of China and Hong Kong, each of which shall be treated as a country for purposes of this Agreement.
1.83 Third Party means an entity other than (a) Lilly and its Affiliates and (b) Hutchison and its Affiliates.
1.84 Third Party Manufacturer is a Third Party that Manufactures on behalf of Hutchison.
1.85 Valid Claim means (a) a claim of an issued and unexpired Patent included within the Hutchison Patents in a country which has not been permanently revoked or held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which decision is not appealable or is not appealed within the time allowed for appeal, and has not been abandoned, disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise in such country or (b) a bona fide claim of a pending patent application included within the Hutchison Patents in a country that has not been (i) cancelled, withdrawn or abandoned without being refiled in another application in the applicable jurisdiction or (ii) finally rejected by an administrative agency action from which no appeal can be taken or that has not been appealed within the time allowed for appeal; provided that any claim in any patent application pending for more than [**] years from the earliest date on which such patent application claims priority shall not be considered a Valid Claim for purposes of the Agreement from and after such [**] year date unless and until a patent containing such claim issues from such patent application.
2. SCOPE AND GOVERNANCE OF THE COLLABORATION.
2.1 General.
(a) Scope.
Pursuant to and subject to the terms of this Agreement, the Parties agree to collaborate with respect to the Development of the Product in the Field with the goal of obtaining Regulatory Approval for Product(s) in the Field in the Territory for Manufacturing and Commercialization. Lilly will have exclusive rights to Commercialize the Products in the Field in the Territory pursuant to this Agreement and as further set forth in Article 4 in exchange for royalty and milestone payments to be made to Hutchison as described in Article 7. Responsibility for Manufacture of Clinical Materials and commercial quantities of Product shall be as detailed in Article 5.
(b) Guiding Principles.
The Joint Steering Committee and any appointed sub-committees as set forth in this Article 2 shall perform its responsibilities under this Agreement based on the principles of good faith, prudence and good scientific and business judgment. None of such committees shall have any power to amend, modify or waive compliance under this Agreement. Notwithstanding anything to the contrary in this Agreement, no decision by either Party, or any committee set forth in this Article 2, will be effective if such decision requires the other Party to breach any obligation under this Agreement and all determinations made by any committee shall be subject to and shall comply with the terms of this Agreement.
2.2 Joint Steering Committee.
(a) Membership.
The Parties shall establish a Joint Steering Committee, JSC , to coordinate and oversee activities on which the Parties collaborate under this Agreement. The JSC will be comprised of a senior executive of each Party or their designee from such Party (the JSC Co-Chairs ) in addition to an equal number of representatives from each Party provided there are at least three (3) total representatives from each Party on the JSC, including the JSC Co-Chairs. Within thirty (30) days of the Effective Date, each Party shall notify the other of its representatives to the JSC and the JSC shall hold its first organizational meeting. Each Party may replace any of its appointed JSC representatives or its co-chair at any time upon five (5) days prior written notice to the other Party. The role of the JSC Co-Chairs shall be to convene and preside at meetings of the JSC, but the JSC Co-Chairs shall not be entitled to prevent items from being discussed or to exercise a casting vote in the event there is a tie. Each Party shall have the right, upon written notice to the other Party, to have present at the JSC meetings a reasonable number of additional, non-voting participants as observers at such meetings (provided such non-voting observers have confidentiality obligations to such Party that are at least as stringent as those set forth in this Agreement). Such additional participants shall not be deemed to be, or have any rights or responsibilities of, a member of the JSC. Each Party will designate a member of management who will be the primary contact for that Party. The primary contacts of the Parties shall be responsible for scheduling the meeting, circulate meeting agendas, draft
minutes for each JSC meeting and circulate such minutes either in writing or electronically for both Parties approval of the JSC for that purpose.
(b) Responsibilities.
The responsibilities of the JSC and, as delegated by the JSC to its subcommittees, shall be:
(i) to provide a vehicle by which the Parties may share information regarding the overall strategy for the Development of Product(s);
(ii) to generate, approve and implement the Initial Development Plans and budgets and Development Plans and budgets for Subsequent Development of Products, including any clinical trials, and any subsequent amendments to the Development Plan;
(iii) to review and advise on any Third Parties used or to be involved in Development (CRO, CMO, etc.);
(iv) to facilitate the exchange of Information between the Parties with respect to the Development activities hereunder and to establish procedures for the efficient sharing of Information necessary for the Parties to fulfill their respective responsibilities with respect to Development of Products hereunder;
(v) to review and support an overall regulatory strategy established for the Product in the Field in the Territory, and to allocate the responsibility for regulatory activities between the Parties as contemplated by Article 6, below;
(vi) to review and support the Manufacturing Strategy; and to allocate responsibility for manufacturing activities between the Parties as contemplated by Article 5.1;
(vii) to discuss and give input regarding the information set forth in Commercialization reports submitted by Lilly to the JSC pursuant to Article 4.1, including the Commercialization strategy with respect to Products in the Field in the Territory;
(viii) to create such subcommittees as the JSC may find necessary or desirable from time to time, including a Development subcommittee, a Manufacturing subcommittee, a Commercialization subcommittee, a regulatory subcommittee and an intellectual property subcommittee (all such subcommittees, as practicable, to be formed at the JSCs first organizational meeting with the exception of the Commercialization subcommittee);
(ix) to oversee the activities of subcommittees created under this
Agreement, and to resolve any issues that such subcommittees cannot resolve; and
(x) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties.
(c) Decision Making.
The JSC and its subcommittees shall make decisions unanimously, with each Partys representatives collectively having one (1) vote, which vote is to be cast by such Partys co-chair, or, in the absence of the co-chair, another of such Partys representatives on the JSC or subcommittee designated by any such Partys co-chair. At least one (1) representative from each Party shall be present at all meetings of the JSC or subcommittee, provided, however, that no Party shall have the right to boycott meetings as a means to avoid action by the JSC or subcommittee.
(d) Dispute Resolution.
Subject to the terms and conditions of this Agreement, If the JSC is unable to decide or resolve unanimously any matter properly presented to it for action within ten (10) Business Days, including as referred to the JSC by a subcommittee, at the written request of either Party, the issue shall be referred to senior management of each Party for resolution, who shall promptly meet and attempt in good faith to resolve such issue within thirty (30) days. If senior management cannot resolve such matter within the above-mentioned thirty (30) day period, then except for those matters set forth below, the matter shall be decided by mutual agreement of the then co-chairs of the JSC (such matters within the JSCs jurisdiction and not subject to clause (i) or (ii) of this Article 2.2(d), Mutual JSC Matters ). For clarity, any decision to develop a product that is not an Initial Product or to develop a Product for an indication that is not an Initial Indication shall not be a decision subject to one Partys final decision-making authority pursuant to clause (i) or (ii) of this Article 2.2(d) and shall require the mutual consent of the Parties.
(i) Hutchison shall have final decision-making authority for [**]
(ii) Except as expressly set forth in this Agreement, Lilly will have the final decision-making authority for all other material Development
decisions with respect to a Product if Lilly [**]
(e) Limitations.
The JSC shall have no authority (a) to amend or interpret this Agreement, or (b) to determine whether or not a breach of this Agreement has occurred.
2.3 JSC Meetings.
Within thirty (30) days of the Effective Date, the JSC will hold an in-person organizational meeting at a mutually agreed upon location to establish the JSCs operating procedures. Following such initial meeting, JSC meetings shall be held at least four times per year or as often as mutually agreed by the Parties. A JSC meeting may be held by audio, video or other electronic means but at least one meeting per year shall be held in person. After the initial meeting above, the location of in-person JSC meetings will alternate between the Parties, unless otherwise agreed by the members of the JSC. Each Party will bear the expense of its respective JSC members participation in JSC meetings. At least five (5) Business Days prior to each JSC meeting, each Party shall provide written notice to the other Party of agenda items proposed by such Party for discussion or decision at such meeting, together with adequate and appropriate information related thereto. The JSC Chairman shall appoint a secretary for the purpose of taking the minutes of Committee meetings, and for such other administrative functions as may be assigned mutually by the Parties (the Secretary ). Within ten (10) days after each meeting, the Secretary shall prepare and distribute to all members of the JSC draft minutes of the meeting. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC and a list of any issues to be resolved by the executives. Minutes will be deemed approved unless a member of the JSC objects to the accuracy of such minutes within ten (10) Business Days of receipt of such minutes .
2.4 Committee Structure following First Commercial Sale.
From time to time and, in any event, as soon as practicable following the first anniversary of the First Commercial Sale of a Product, the Parties shall review the committee structure provided for in this Article 2 and eliminate committees or adjust their responsibilities so as to reflect the then current status of collaborative Development efforts, if any, and the commencement of Commercialization by Lilly.
3. PRODUCT DEVELOPMENT
3.1 Development Plan.
(a) The initial Development plan for the Development of Product for the Initial Indications is attached hereto as Exhibit B (as amended from time to time pursuant to this Agreement, the Development Plan ). The Development Plan shall include: (a) all indications of Products then being pursued; (b) a description of the Development activities to be conducted by each Party and the relevant deliverables; (c) all relevant decision points to continue Development of a Product in an indication; (d) a budget for the Development activities to be conducted in the Territory with respect to Products in the Territory until Regulatory Approval of such Product for such indication; (e) an estimated timeline for the performance of activities; and (f) FTE estimates.
(b) On no less than an annual basis, the JSC shall review the Development Plan and recommend any amendments or changes to the Development Plan and approve any such amendments or changes.
(c) The Development of Products shall be conducted by Parties pursuant to good clinical practices (GCP) and good laboratory practices (GLP). GLP means all applicable Good Laboratory Practice standards, including, as applicable, as set forth in the then current good laboratory practice standards promulgated or endorsed by the FDA as defined in 21 C.F.R. Part 58, or the equivalent Applicable Laws in the Territory, each as may be amended and applicable from time to time. GCP means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable (a) as set forth in the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the Territory, (b) the Declaration of Helsinki (2004) as last amended at the 52nd World Medical Association in October 2000 and any further amendments or clarifications thereto, (c) U.S. Code of Federal Regulations Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (d) the equivalent Applicable Laws the Territory, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.
3.2 Conduct of Initial Development: Proof of Concept.
(a) The JSC will outline the data analysis criteria for all POC studies for each indication. The POC data for all indications will be reviewed by an independent data review committee or process and all POC studies will be conducted and managed by global or equivalently qualified CROs.
(b) Hutchison shall conduct Development of Product for an Initial Indication until (a) (i) with respect to a Product for the 3 rd line colorectal cancer or 2 nd line advanced gastric cancer Initial Indication, such Product for such Initial Indication has achieved Positive POC or (ii) with respect to a Product for the 3 rd line non-small cell lung cancer Initial Indication, the proof of concept (Phase IIa) study for such Product for such Initial Indication has been completed or (b) with respect to any Product for an Initial Indication, Hutchison deems, in good
faith, that Positive POC cannot be achieved in a commercially reasonable fashion by such Product for such Initial Indication (such Development, the Initial Development ). The JSC will ensure that the design and execution of each Phase II trial of Initial Development meets cGMP and is designed to achieve Positive POC.
3.3 Initial Development Funding. [**]
3.4 Subsequent Development and Costs.
(a) Following the Initial Development of a Product for an Initial Indication, the JSC will have a thirty (30) day review period, such review period to commence after receipt from Hutchison of a full data set, including but not limited to, all relevant source data, quality assessment, efficacy, safety, statistical analysis, records, final analysis and raw data as would be expected to be ready three to four weeks following the final data base lock associated with the achievement of Positive POC ( Full Data Set ). In order to maximise efficiency and speed of development, Lilly will work with Hutchison via the JSC to conduct diligence in parallel with the POC studies to ensure the quality of the POC studies. In order to facilitate Lillys final diligence review of the Full Data Set, Hutchison will provide Lilly with at least four weeks advance notice of the anticipated commencement of the review period and will make arrangements and where needed, will accompany Lilly, in order to allow Lilly personnel to visit relevant Third Party sites during the first two weeks of the review period. Any delays in conducting such visits which were not in the reasonable control of Lilly shall be considered in adding proportionate time to the review period. Except in the case of a Product for 3 rd line non-small cell lung cancer Initial Indication for which such invoicing shall be dealt with under Article 3.4(a)(ii) below, Hutchison will issue an invoice for payment of the relevant milestone payment under Article 7.2 immediately following such review period unless Hutchison receives a notice of termination for a Major Unexpected Safety Issue in accordance with Article 13.4.
(i) If a Product has achieved Positive POC for the 3 rd line colorectal cancer or 2 nd line advanced gastric cancer Initial Indication, then (A) the POC milestone under Article 7.2 (i.e., #1) will have been met and the corresponding milestone payment will be payable to Hutchison and (B) the development of such Product for such Initial Indication into Phase III clinical trials (which shall be Subsequent Development under this Agreement) will be continued in accordance with the terms of this Agreement. For the avoidance of doubt, once a Product for the 3 rd line colorectal cancer or 2 nd line advanced gastric cancer Initial Indication has achieved Positive POC, the Parties shall be deemed to have agreed that such Product shall proceed into Subsequent Development (i.e., Phase III registration studies or trials pursuant to this Agreement). [**]
(ii) [**]
(c) [**]
(d) If a Product has achieved Positive POC for an Initial Indication or Lilly, pursuant to Article 3.4(a)(iii), elects to conduct Subsequent Development of a Product for an Initial Indication, then (i) Hutchison shall continue to be responsible for all future Subsequent Development activities, (ii) all Development Costs incurred for a Product for an Initial Indication after such achievement or election shall be deemed Subsequent Development Costs, (iii) Lilly shall be responsible for the payment of the proof of concept milestone for such Product in such Initial Indication under Article 7.2 and (iv) Lilly shall reimburse Hutchison for [**] of Development Costs incurred by Hutchison (see Appendix B, page 7; Development Costs will be the Total Costs as set forth in the table) and its Affiliates for Phase III development of such Product for such Initial Indication whether or not such Development Costs are incurred by Hutchison before or after Positive POC achievement.
(e) Hutchison will be responsible for [**] of all Subsequent Development Costs and Lilly shall be responsible for [**] of all Subsequent Development Costs. If any Subsequent Development Costs incurred by Hutchison for an activity exceed the amounts budgeted in the applicable budget in the Development Plan for such activity, such excess costs shall be deemed Subsequent Development Costs for the purposes of this Agreement; provided that, to the extent such excess costs are more than [**] of the amounts budgeted in the applicable budget in the Development Plan for such activity, then such excess costs above such [**] threshold shall only be deemed Subsequent Development Costs for the purposes of this Agreement to the extent such excess costs are not due to Hutchisons failure to conduct activities in a manner consistent with the Development Plan or have been approved by the JSC. All amounts paid to Third Parties by Hutchison for Development activities shall be reimbursed as Development Costs at cost without any mark-up. Following receipt of Regulatory Approval, [**].
(f) In addition to Hutchisons right to pursue Development of a Product that has not achieved Positive POC pursuant to Article 3.4(b), in the event a Party wishes to pursue a Life Cycle Planning Indication for a Product, it shall notify the other Party and submit to such Party an outline for a development plan (including a high-level budget) for such Life Cycle Planning Indication and all relevant information it believes, in good faith, to be reasonably necessary for the other Party to elect whether or not to pursue such Life Cycle Planning Indication for such Product under this Agreement. The other Party (the Electing Party ) must elect, in writing to the other Party, within sixty (60) days of receiving this information, whether or not to proceed with such development under this Agreement.
(g) If the Electing Party decides to pursue a Life Cycle Planning Indication for a Product, (A) milestones will be paid pursuant to this Agreement for such Product for such Life Cycle Planning Indication pursuant to Article 7.2 (as described in Milestone Event #4), (B) all Development Costs for a Product for a Life Cycle Planning Indication shall be deemed Subsequent Development Costs, (C) the JSC shall, as a Mutual JSC Matter, generate and approve an amended Development Plan to include such Life Cycle Planning Indication and (D) Hutchison shall be responsible for all Development activities for such Product for such Life Cycle Planning Indication.
3.5 Development Records and Reimbursement of Hutchison Costs .
Hutchison shall track and calculate all Development Costs incurred by it. All Development Costs shall be determined in accordance with IFRS. Hutchison shall keep a complete and accurate record of all such costs. Within [**] days after the end of each Calendar Quarter, Hutchison shall submit to Lilly a report setting forth in reasonable detail the Development Costs incurred by it during such Calendar Quarter, with an allocation of such costs between the Parties consistent with Articles 3.3 and 3.4, along with such supporting documentation as Lilly may reasonably request, and provide Lilly an invoice for any amounts due from Lilly. Lilly shall pay the amount due within [**] days after receipt of the invoice and appropriate documentation.
3.6 Rights to Engage Development Subcontractors .
Each Party shall have the right to engage Third Party contractors to perform any portion of its Development obligations hereunder; except that no Third Party contractor can be debarred or disqualified by the Regulatory Authority. Each Party shall be responsible for ensuring that, prior to any such engagement, any Third Party contractors are subject to written agreements containing terms and conditions: (i) consistent with the relevant terms and conditions of the Agreement protecting the rights of the Parties under the Agreement including imposing obligations of confidentiality on each such subcontractor; (ii) that vests ownership of any and all inventions developed by such subcontractor relating solely to Products in the course of
performing such subcontracted work in the contracting Party; (iii) that does not impose any payment obligations or liability on the other Party without the prior written consent of the other Party and (iv) that is otherwise consistent with the terms of the Development Plan to the extent applicable (such contractors, Subcontractors ). Each Party shall advise the other Party in writing at least fifteen (15) days in advance of any engagement of a Subcontractor. Further, to the extent practicable, Hutchison shall use Commercially Reasonable Efforts to cause their existing contractors, including their existing contract Manufacturers of Clinical Materials, to cooperate with Lilly as reasonably necessary for Lilly to fulfill its Development and Commercialization obligations under this Agreement.
4. COMMERCIALIZATION AND COMPLIANCE .
4.1 Overview.
Lilly shall have full responsibility and authority for all aspects of the Commercialization of Products in the Field in the Territory at its sole expense. Lilly shall use Commercially Reasonable Efforts to Commercialize Products, in compliance with the terms and conditions of the Agreement with a goal to maximize profits from Net Sales of Products. Lilly shall book all Third Party end user sales of the Products, and shall have the sole right and obligation to determine all pricing of the Products. Lilly shall bear all of the costs and expenses incurred in connection with all such Commercialization activities. Through the JSC, Lilly shall provide Hutchison with quarterly reports of the activities it has undertaken with regard to Commercializing Products in the Territory. In addition, Lilly shall meet with Hutchison, at Hutchisons request and no more than two (2) times per year, to report on the activities it has undertaken with regard to Commercializing Products in the Territory and to provide a forum for Hutchison to provide feedback regarding such Commercialization activities, which feedback shall be reasonably considered by Lilly in developing its future Commercialization strategy for Products.
4.2 Product Trademark, Labeling; Promotional Materials.
Lilly shall own and be responsible for obtaining and maintaining trademarks for the Products. Lilly shall be responsible for designing and supplying the product labeling and promotional materials for the Products. Lilly shall be responsible as to the manner in which Products shall be presented and described to the medical community in any promotional materials and the placement of the names and logos of the Parties therein, in each case as permitted by Applicable Law and consistent with the labeling for the Products approved by the applicable Regulatory Authority. To the extent permitted by Applicable Law, in Commercialization under this Agreement, product labeling shall identify the Products as Manufactured by Hutchison or its approved Third Party Manufacturer.
4.3 Compliance Obligations.
Each of the Parties shall, and shall cause their respective Affiliates to, comply in all material respects with the terms of this Agreement as follows:
(a) Compliance with Applicable Laws. Each of the Parties shall, and shall cause their respective Affiliates to, conduct all activities under this Agreement in such a manner
as to comply in all material respects with all Applicable Laws.
(b) Compliance with Party Specific Regulations. The Parties agree to cooperate with each other as may reasonably be required to ensure that each is able to fully meet its obligations with respect to the Party Specific Regulations applicable to it. Neither Party shall be obligated to pursue any course of conduct that would result in such Party being in material breach of any Party Specific Regulation applicable to it. All Party Specific Regulations are binding only in accordance with their terms and only upon the Party to which they relate.
(c) Compliance with Internal Compliance Codes. All Internal Compliance Codes shall apply only to the Party to which they relate. The Parties agree to cooperate with each other to ensure that each Party is able to comply with the substance of its respective Internal Compliance Codes and, to the extent practicable, to operate in a manner consist with its usual Compliance related processes.
(d) Compliance Agreement. From time to time, the Parties shall discuss activities necessary to ensure Compliance. If either Party requests, the Parties will negotiate in good faith and execute a written Compliance Agreement that will set forth and define the compliance policies, standards, and procedures the Parties will adhere to when conducting activities under this Agreement. The Compliance Agreement may also include provisions relating to interactions between the respective compliance organizations of the Parties, sharing of Compliance related information, execution of training, implementation and monitoring activities, and resolution of Compliance issues that may arise in accordance with the rule established in Article 1.6.
(e) Responsibility for Compliance; Disputes Regarding Compliance Matters. Each Party is solely responsible to ensure Compliance by it and its Affiliates.
(f) Review Procedure for Marketing Materials and Activities. All detailing, promoting, communication, marketing and selling activities, including promotional and educational materials and messages, used in connection with the activities contemplated by this Agreement shall comply in all material respects with Applicable Laws and Party Specific Regulations, and be consistent with the substance of the Internal Compliance Codes of Lilly.
(g) Anti - Bribery Commitments. Without limiting the other obligations of the Parties set forth in this Article, in connection with any activities of the Parties under this Agreement, the Parties confirm that they have not given, offered, promised, or authorized, and will not give, offer, promise, or authorize, any payment, benefit, or gift of money or anything else of value, directly or through a Third Party, to (i) any Government or Public Official, as defined below; (ii) any political party, party official or candidate for public or political office; (iii) any person while knowing or having reason to know that all or a portion of the value will be given, offered or promised, directly or indirectly, to anyone describe in terms (i) or (ii) above; or (iv) any owner, director, employee, representative or agent of any actual or potential customer of the parties, for purposes of influencing any act or decision of such individual in his official capacity, inducing such individual to do or omit to do any act in violation of the individuals duty, inducing the individual to use the individuals official influence with a government to affect or influence an act or decision of the government, or to secure any improper advantage in order
to assist in obtaining or retaining business. The parties shall comply with all applicable anti-bribery laws of any jurisdiction, including any record keeping requirements of such laws, in the Countries where the Parties have their principal places of business and where they conduct any activities under this Agreement or any related agreements. For the purposes of this Article, Government or Public Official means any officer or employee or anyone acting in an official capacity on behalf of: a government or any department or agency thereof; a public international organization (such as the United Nations, the International Monetary Fund, the International Red Cross, and the World Health Organization), or any department, agency or institution thereof; or a government-owned or controlled company, institution, or other entity, including a government-owned hospital or university.
5. MANUFACTURE AND SUPPLY .
5.1 General Overview.
(a) The JSC, as a Mutual JSC Matter, shall establish an overall strategy for supply of Clinical Materials and Products for Development and Commercialization purposes (the Manufacturing Strategy ), to the extent consistent with Hutchisons and Lillys obligations and rights under this Agreement. The Manufacturing Strategy shall address manufacturing quality standards and the Parties and/or, as applicable, the Third Party Manufacturer shall enter into a separate Quality Agreement for the Product. Subject to this Article 5.1, Hutchison shall be responsible in consultation with Lilly for the supply of, and shall have the right to supply, all clinical and commercial supplies of the Product for use under this Agreement. To the extent and on the timeline contemplated by the Manufacturing Strategy, Hutchison shall (i) retain a Third Party Manufacturer for the supply of drug substance, (ii) take all necessary actions, with consultation from Lilly, to establish a drug product site for the clinical and commercial supply of finished Product and (iii) retain a back-up manufacturer, a Third Party Manufacturer, selected in consultation with Lilly, for the clinical and commercial supply of finished Product, such Manufacturer to be approved by Lilly, such approval not to be unreasonably withheld or delayed.
(b) Notwithstanding anything to the contrary in this Agreement, Lilly may require Hutchison to use a Third Party Manufacturer for all or some of the clinical supply of Products if (A) Lilly believes, reasonably and in good faith, that Hutchison has not shown the capability to satisfactorily deliver sufficient quantity of Products in acceptable quality to the clinic for the Development activities contemplated under this Agreement and the Development Plan, (B) Hutchison has not received necessary approval from the applicable Regulatory Authority to Manufacture clinical supplies of Products or (C) Lilly believes, reasonably and in good faith, that Hutchison does not have systems in place with respect to the Manufacture of clinical supply of Products that comply with applicable quality and pharmcovigilance agreements (such as those prepared under this Agreement) and Applicable Law.
(c) The Parties shall enter into a series of agreements detailing the obligations and responsibilities of each Party as it pertains to the supply of Product in the Territory. The agreements shall include supply agreements, Quality Agreements and Manufacturing Responsibilities Document (MRD) appropriate for the Manufacture of the Product(s).
(d) Lilly will purchase all of its requirements of Products for the Territory from
Hutchison and Hutchison agrees to supply Lillys forecast for Products for the Territory. Hutchison agrees to supply the Product to Lilly at a transfer price that accounts for Hutchisons COGS. Product costing must be consistent with GAAP or IFRS and as mutually agreed upon by both Parties.
(e) Following the Term of the Agreement but not after an early termination, if Lilly so chooses, the Parties will enter into a continuing supply agreement for the supply of Product for the Territory or part thereof wherein the Product will be supplied at arms-length market terms.
5.2 General Product, Manufacturing and Supply Responsibilities .
(a) General Product Responsibilities of Lilly. Lilly shall be responsible for the following activities regarding a Product: (i) facilitating all sales of Product in the Territory, (ii) all government price reporting, calculations, and payment processing obligations, (iii) keeping the Product (following receipt by Lilly) in good condition and with due care and in compliance with all Applicable Laws, (iv) handling all commercial contracting obligations, including managed care, hospitals, government programs and all other commercial agreements, and (v) booking all sales of Products, and collection of outstanding receivables for any Product.
(b) General Product Responsibilities of Hutchison. Hutchison shall be responsible for the following regarding a Product: (i) holding itself or through its Third Party Manufacturer the Manufacturing Authorizations and accordingly being responsible for all government reporting obligations in connection therewith, (ii) making the Product available at suitable warehouses for Lilly to pick up such Product, and (iii) providing Lilly with any information Controlled by Hutchison that Lilly may reasonably request to meet all government reporting obligations for the Product.
(c) Supply Agreement, Quality Agreement and Manufacturing Responsibility Document. The Parties shall negotiate in good faith and enter into and adopt a quality agreement (the Quality Agreement ) within ninety (90) days of the Effective Date, a supply agreement and a Manufacturing Responsibility Document or MRD prior to one (1) year of the anticipated approval of a Product by CFDA, each of which shall be within the purview of the applicable portion of the cGMP. The supply agreement shall include but not be limited to, traditional supply terms, product costing, forecast obligations and access to Manufacturing records and facilities including the right for Lilly at its discretion to have a person in the plant at any Manufacturing site used by Hutchison or its Third Party Manufacturer during Manufacturing activities related to the Product. The MRD will contain, among other provisions, certain procedures and personnel contacts relating to the supply of Products for the Territory that will be developed, approved and updated by the Parties, and the shelf-life of the Product and Samples. The supply agreement and the MRD will be subject to and not be inconsistent with the terms of this Agreement and in the event of conflict between the terms of the MRD and this Agreement, the terms of this Agreement will control. Articles of the supply agreement and MRD may be modified from time to time by mutual written agreement of the Parties. The Quality Agreement shall include, but not be limited to, the Specifications for a Product, Product audit rights, including specifications and audit rights for the Samples, which shall contain customary terms as per the cGMP as mandated by the CFDA. Besides the authorized representatives of the Parties, representatives of each Partys
quality units and safety units shall sign the Quality Agreement and Safety Agreement, respectively. Representatives of each Partys quality unit and supply chain unit shall sign MRD. In the event the information in, or the terms of, the Quality Agreement, Safety Agreement or the MRD conflicts with this Agreement, the terms of this Agreement will control, provided that with respect to specific technical matters that directly impact the quality of a Product, the terms of the Quality Agreement will control.
(d) Inspection by Lilly . Upon fifteen (15) Business Days prior written notice to Hutchison or, as applicable, Third Party Manufacturers, and during normal working hours, shall allow Lilly and/or its authorized representative or agents, to inspect the premises where the Product manufacturing and operations are conducted for purposes of overseeing and auditing the Product Manufacture and operations (the Audit ), provided that such Audit does not (i) unduly disrupt the normal operation of the business or (ii) require Hutchison or as applicable the Third Party Manufacturer to provide Lilly or its authorized representatives or agents any trade secret or confidential information that is not related to the Manufacture of the Product(s). In addition, the Parties agree that any such Audit shall not be conducted more than once every calendar year. Notwithstanding the foregoing sentence, Lilly shall have the right to conduct an additional Audit prior to each Launch of a new Product related to such Product. Notwithstanding the above, for sufficient Cause (as defined below), which shall be communicated in writing to Hutchison, Lilly may have immediate access during normal working hours limited to the extent of inspection directly related to such Cause, with appropriate protections to preserve the confidentiality of Third Party information at the applicable facility. Cause shall mean a Product safety or quality issue that has been specifically identified, or as mandated by Regulatory Authorities and where time is of the essence. Any such audit conducted for Cause shall not supplant or negate the right for the annual Audit.
(e) Notice of Inspections . During the Term of this Agreement, each Party or, as applicable, the Third Party Manufacturer shall provide the other Party with prompt notice of any governmental or regulatory review, audit or inspection of its facility, processes, or products that relate to the subject matter of this Agreement. The audited party shall provide the non-audited party with the results of any such review, audit or inspection to the extent it relates to the subject matter of this Agreement. To the extent practicable, the non-audited party shall provide assistance to the audited party in responding to any such review, audit or inspection to the extent it relates to the subject matter of this Agreement.
5.3 Product Manufacture and Distribution.
(a) Hutchison, in consultation with Lilly, shall be responsible for obtaining the active pharmaceutical ingredients required to Manufacture each Product from a supplier acceptable to and approved by Lilly (such approval not to be unreasonably withheld or delayed), and the Manufacture of each finished Product according to Specifications approved in the relevant Manufacturing Authorization, in each case during the Products life. Lilly shall have the right to audit all Product manufacturing sites, including Hutchison and Third Party Manufacturers, who are Manufacturing the active pharmaceutical ingredients. In particular, based upon an ordering process established within the MRD, Hutchison will make such finished Products available for pick up by Lilly, its authorized agent, or a common carrier engaged by Lilly. Lilly will, or will cause its Affiliates to: (i) to cause its freight carrier to pick up the
Products promptly (and in any event, not later than ten (10) Business Days) following receipt of notice from Hutchison that such Products are available for pick-up; (ii) to cooperate with the applicable Regulatory Authorities in the Territory required for clearance of the Products, provided that Hutchison will provide the necessary information reasonably requested by Lilly in order for Lilly or its Affiliate to provide such cooperation; and (iii) to have the Products delivered to warehouses designated by Lilly or an Affiliate of Lilly in the Territory as promptly as practicable.
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(f) Lilly will store the Product in Lilly designated warehouses in good condition and with due care, and in compliance with all Applicable Laws for the Territory, including the applicable cGMP regulations for storage facilities.
(g) Hutchison or as applicable the Third Party Manufacturer (hereinafter, jointly referred to as Hutchison in this Article 0) will ensure that Product at its warehouses made available to Lilly for pick-up will have a minimum of [**] of its approved shelf life remaining from the date Hutchison notifies Lilly that the Products are available for pick up in accordance with an accepted purchase order.
5.4 Forecasts, Raw Materials and Allocation of Product.
(a) After the Product obtains Regulatory Approval, Lilly will provide Hutchison with a quarterly non-binding rolling forecast of its anticipated requirements for that Product for the next twelve months.
(b) At least [**] days prior to the expected launch of the Product, and thereafter commencing with the launch of the Product, Lilly will provide to Hutchison (i) [**] thereafter, Lillys good faith estimate of the total quantity of the Product expected to be ordered for the following [**] calendar months, broken down into calendar months (each months amount, the Forecast ), and (ii) on or before the [**] for each year, Lillys good faith estimate of the total quantity of the Product expected to be ordered [**]. The Parties agree that such Forecasts and such estimates will be for general planning purposes only, and will not be binding on Hutchison or Lilly except for the [**] of these forecasts which will be binding for both Parties. This forecasting process may be modified from time to time by the mutual consent of the Parties. Hutchison agrees to make available Manufacturing facilities and equipment that is necessary in order to Manufacture the quantity of Products set forth in Lillys Forecast.
(c) Reasonable quantities of unique components or raw materials, used in the Manufacture of the Product, shall be purchased or Manufactured by Hutchison, at its own cost and expense, for use in supplying Lillys requirements for the Product under this Agreement based on Lillys Forecast.
(d) If the available supply of raw materials or other inputs to the Product, including production time, for purposes of Manufacturing the Product is in short supply such that Hutchison is unable to fulfill completely outstanding Product orders hereunder, Hutchison shall allocate such available supply of Product between Lillys Product and Product that Hutchison may be supplying to itself or other Third Parties (either via itself or a Third Party Manufacturer) based on the then current years sales forecast. Hutchison undertakes that it or, as applicable, its Third Party Manufacturer, shall carry in safety stock inventory a minimum [**] supply of the raw materials and a [**] supply of the Product to accommodate Lillys orders of the Product for use consistent with the Forecast.
5.5 Shipments, Title and Returns.
(a) All Products will be shipped to Lilly Ex Works (Incoterms 2010) Hutchisons shipping point.
(b) Hutchison, concurrently with each shipment of Product to a Lilly designated warehouse, shall provide to Lilly for the Product included in such shipment: (i) normal and customary documentation, including bill of lading; (ii) a certificate of compliance that such lot meets the Specifications of the Product; (iii) a certificate of analysis and any other documentation as outlined within the Quality Agreement; and (iv) any other documentation required by regulatory authorities to transport the Product.
(c) Lilly shall be responsible for all return processing by customers of the Product in the Territory in accordance with its own guidelines and in compliance with its own trade account policy, and shall notify Hutchison regularly about any returns.
5.6 Non-Conformity Product .
(a) Upon receipt of a shipment of a Product, Lilly shall inspect such shipment for physical damage and compliance with the shipping documentation and carry out any reasonable inspection procedures that Lilly considers appropriate in line with industry standards. Any patent defects, quantitative defects, damage or noncompliance (excluding Latent Defects) shall be reported to Hutchison within [**] Business Days. In addition, Lilly shall be entitled but not obligated, at its own cost and expense and using the test methods registered in the regulatory documents to test any and all Products, as applicable, delivered to it hereunder to determine whether such Product complies with the requirements of the Quality Agreement and the registered Specifications. If Lilly reasonably determines that such Product, as applicable, fails to conform to the Quality Agreement or registered Specifications or is otherwise inappropriate for use (a Non-Conformity ), Lilly shall notify Hutchison in writing within [**] Business Days of the discovery of the claimed Non-Conformity such as and including Latent Defects and reason(s) that Lilly has reasonably determined that a Non-Conformity exists, and provide Hutchison as soon as practicable with material, data or information supporting the reason(s) along with a sample of the non-conforming Product. Lilly, at Hutchisons request, shall provide Hutchison with the opportunity to conduct its own tests on such Product as soon as reasonably practicable but not to exceed [**] days from receipt of notice from Lilly regarding such Non-Conformity. If Hutchison concurs with the Non-Conformity, then Hutchison will replace all Products with the Non-Conformity, at their expense, as soon as practicable and shall reimburse Lilly for any expenses related to transporting the non-conforming Product back to Hutchison. If Hutchison has delivered a quantity of Product that is less than the quantity stated in any invoice or bill of lading, Hutchison shall, at its own cost and expense, supply Lilly with any missing quantities of Product as soon as reasonably practicable after receipt of such notice.
(b) Notwithstanding the foregoing, Lilly shall have the right to reject any batch of Product having Latent Defects prior to the expiry of such batch of Product. If Hutchison agrees that such Product contains a Non-Conformity, Hutchison shall, at its option, replace the non-conforming Product or repay the full amount of any payments, including shipping and recall
costs for such Product. If Hutchison does not agree with Lillys determination that such Product contains a Non-Conformity, then after reasonable efforts to resolve any disagreement between the Parties, either Party may submit a sample of such Product to a mutually agreed upon independent Third Party who is an expert or is familiar with the industry to determine whether the Product meets the Specifications. The independent partys results shall be final and binding and if such results indicate that the Product contained a Non-Conformity, Hutchison shall, at its option, replace the non-conforming Product or repay the full amount of any payments for such Product. Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the non-prevailing Party.
(c) If Lilly has not notified Hutchison within [**] Business Days of receipt of the Products that the Products received by Lilly contains a Non-Conformity, such Product shall be deemed accepted by Lilly, shall constitute a waiver of any claims Lilly may have against Hutchison with respect to payment for such shipment and shall constitute agreement by Lilly to pay Hutchison for such Product in accordance with the payment obligations under this Agreement. Notwithstanding the foregoing, acceptance of Product by Lilly (whether expressly accepted or deemed accepted) will not constitute a waiver of any rights of Lilly with regard to such Product, including the right to revoke its acceptance of such Product and to withhold acceptance for any Latent Defects discovered by Lilly and reported to Hutchison within [**] Business Days of discovery of such Latent Defects.
5.7 Hutchisons Supply Covenants .
(a) Hutchison covenants to Lilly that Hutchison shall ensure that the Products on the date of their respective shipment to, or pick up by Lilly (as applicable) pursuant to this Agreement:
i. will conform to the applicable Product Specifications (as agreed between the Parties);
ii. would have been produced, stored and tested in accordance with cGMP requirements;
iii. will be adequately contained, packaged and labeled and materially conform to the affirmations of fact on the container of the Product; and
iv. the Product shall have an approved shelf-life that will conform to Article 5.3(f) as of the date the Product is available for pick up in accordance with an accepted purchase order by Lilly.
(b) Hutchison covenants and undertakes to convey to Lilly good title in the Territory to the Products free of any security interest, other lien, or encumbrance.
(c) Hutchison further warrants that it will act with due care, diligence and skill in its dealings with the Product and will act with promptness, diligence and professionalism in its dealings with Lilly.
5.8 Lillys Pick-Up Covenants .
Lilly covenants to Hutchison that Lilly shall ensure that the Products are duly and promptly picked up by Lilly pursuant to Article 5.2(a), and that Lilly will act with due care,
diligence and skill in its dealings with the Product and will act with promptness, diligence and professionalism in its dealings with Hutchison.
5.9 Limited Warranty; Disclaimer and Scope of Liability . Hutchison warrants to Lilly that Clinical Materials and Products delivered hereunder will (i) if Manufactured by Third Parties, the Third Parties shall be under an obligation to comply with cGMP and other Applicable Laws of the Territory, and be in accordance with the Specifications, (ii) if Manufactured by Hutchison, be Manufactured in accordance with cGMP and other Applicable Laws and other rules and regulations of the Territory and be in accordance with the Specifications, (iii) conform to the Specifications at the time of delivery, and (iv) not be adulterated or misbranded. Except as expressly set forth in this Article 5.9, Hutchison does not make, and specifically disclaims, any express or implied representation or warranty as to the Manufacture or composition of the Products or the components thereof.
5.10 Third Party Manufacturing Arrangements. Notwithstanding anything to the contrary in this Agreement, to the extent Hutchison has any obligation under this Agreement to require a Third Party Manufacturer to abide by any terms of this Agreement, Hutchison shall solely be obligated to use, in good faith, Commercially Reasonable Efforts to include such terms in its agreement with such Third Party Manufacturer; provided , however that, to the extent that the terms of any such agreement with a Third Party Manufacturer differ from the terms of this Agreement, the applicable terms of this Agreement shall be modified to conform to the terms of such agreement with such Third Party Manufacturer.
6. REGULATORY .
6.1 Hutchison Responsibilities .
Hutchison will be responsible for all regulatory activities [**]
6.2 Lilly Responsibilities.
Lilly will be responsible for all Commercialization activities for the Products [**]
6.3 Creation of Safety and Regulatory Agreement .
Representatives of each Party will meet when appropriate depending upon a Products likelihood of obtaining Regulatory Approval to work in good faith to create and develop a safety and regulatory agreement (the Safety Agreement) to be completed no later than one hundred and twenty days after the proof of concept milestone is paid for such Product under Article 7.2.. Such safety and regulatory agreement will include, but not be limited to, roles and responsibilities related to safety management of the Products for Product Development and Commercialization phases, safety data exchange between the Parties, safety surveillance and signal detection, risk management, the management and handling of Product complaints, timely reporting to Lilly of Adverse Events related to a Product and Adverse Event handling and reporting procedures to Regulatory Authorities.
6.4 Safety Audit.
Upon reasonable notification each Party is entitled to conduct an audit of safety and regulatory procedures and practices of the other Party that require evaluation, including on-site evaluations to the extent permitting such evaluations is in control of the audited Party.
6.5 Recalls .
After Lilly begins Commercialization of a Product, Lilly shall be responsible for any recall decision, which shall be made only after consultation with Hutchison. If Lilly, in its discretion, recalls, detains or retains the Product (voluntarily or by order of a Regulatory Authority, which shall be promptly notified to Lilly by the Manufacturing Authorization holder), Hutchison agrees to reasonably cooperate in such actions, at Lillys sole expense. For the sake of clarity, under no circumstances may Lilly initiate a recall of a Product during Development in which Hutchison is the sponsor of the Product, without prior agreement of Hutchison. In the event of a recall after Lilly begins Commercialization of a Product and the recall is a consequence of a manufacturing issue then Hutchison shall be responsible for costs and damages related to the recall.
6.6 Regulatory Obligations .
Except as otherwise provided in Article 2.2, above, and this Article 6, Hutchison shall be responsible for the regulatory strategy, including strategy for filings and label content, in consultation with Lilly, including commercial input. Hutchison shall be solely responsible for all regulatory activities in connection with seeking Regulatory Approvals in the Territory, including communicating and preparing and filing all reports with the Regulatory Authorities. [**]
7. PAYMENTS AND MILESTONES; GUARANTEE .
7.1 Upfront Payment and Condition Subsequent.
(a) Within five (5) days after the Effective Date, Lilly shall pay to Hutchison an up-front payment of Two Million U.S. Dollars ($2,000,000), in consideration for the Development Costs incurred up to the Effective Date of this Agreement and license grant under this Agreement.
(b) In the event that Hutchison provides evidence in the twelve-month period following the Effective Date of this Agreement that establishes, in a manner acceptable to Lilly (such acceptance not to be unreasonably withheld or delayed), that Hutchison either (i) does not reasonably need to obtain a Third Party license (such as, but not limited to, a competent legal opinion that it is not necessary to obtain a Third Party license to give the Parties to the freedom to Develop, Manufacture and Commercialize the Product in the Field in the Territory pursuant to this Agreement, including the right to sublicense, without infringing a valid patent of such Third Party) or (ii) has obtained the necessary Third Party license, at Hutchisons cost, in each case to give the Parties the freedom to Develop, Manufacture and Commercialize the Product in the Field in the Territory pursuant to this Agreement, including the right to sublicense, without infringing a valid patent of such Third Party (such submission of acceptable evidence, the FTO Submission ), Lilly shall pay Hutchison Four Million and Five Hundred Thousand U.S. Dollars ($4,500,000) within thirty (30) days of the FTO Submission.
(c) If Hutchison has not provided the FTO Submission to Lilly pursuant to Article 7.1(b) within the twelve-month period following the Effective Date, Lilly will have the option to, within thirty (30) days following the end of such twelve-month period, to deliver written notice to Hutchison that it desires to terminate the Agreement immediately and at no further expense to Lilly. Upon the delivery of such termination notice, all licenses granted to Lilly hereunder shall expire. If such termination by Lilly is solely due to Hutchisons inability to obtain a required Third Party license, and if Lilly has not yet viewed the proof of concept study data for any of the Initial Indications, then within thirty (30) days of the effective date of termination, Hutchison will pay Lilly Two Million U.S. Dollars ($2,000,000) in consideration for Lillys collaborative efforts. If Lilly elects not to terminate the Agreement, then the Agreement shall continue with Lilly paying all financial obligations as they accrue, except for the four and one half million U.S. dollar ($4,500,000) payment in Article 7.1(b) which shall only be payable by Lilly within thirty (30) days of the FTO Submission pursuant to Article 7.1(b).
7.2 Development Milestone Payments .
Lilly shall pay to Hutchison the Development milestone payments listed below as follows: (i)
within thirty (30) days of the earlier of the date of FTO Submission and Lillys election not to terminate this Agreement pursuant to Article 7.1(c) if the relevant milestone event occurs before such earliest date; or (ii) within thirty (30) days of the milestone event if the relevant milestone event occurs after the date of FTO Submission or Lillys election not to terminate this Agreement pursuant to Article 7.1(c). Each milestone shall be payable only once upon the first occurrence of the described event for any Product.
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7.3 Product Earned Royalties .
(a) Tiered Royalties . Lilly shall pay to Hutchison royalties on the annual Net Sales of all Products in the Territory in the amounts set forth below (all amounts are in U.S. Dollars).
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The above tiered royalties are calculated such that the higher tiered royalties are only paid after the annual Net Sales exceed the top threshold of the previous tier. Attached as Exhibit F is an example of an annual Product royalty payment calculation.
(b) Royalty Term . The above earned royalty (the Royalty Term ) shall be payable on a Product-by-Product and country-by-country basis for the longer of: [**]
7.4 Hutchisons Third Party Obligations and Agreement Payments.
Hutchison shall be responsible for and pay when due all payments, royalties or milestones owed by Hutchison under any agreements entered into by Hutchison and any Third Party relating to the Hutchison Patents or Product required for the Development, manufacturing, importation, or Commercialization of a Product in the Territory . If Hutchison should fail to pay any such amount, Lilly may at its sole option decide to pay any such amount on Hutchisons behalf and to deduct such amount from any milestones or royalties owed to Hutchison hereunder without restriction.
7.5 Reports; Payment of Royalty
During the Term, following the First Commercial Sale of a Product, Lilly shall furnish to Hutchison a quarterly written report for the Calendar Quarter showing the number and description of Products sold, Net Sales of Products sold subject to royalty payments sold by Lilly and its Related Parties on a country-by-country basis, if applicable, during the reporting period and the royalties payable under this Agreement. Reports shall be due on the [**] day following the close of each Calendar Quarter. Royalties shown to have accrued by each royalty report shall be due and payable on the date such royalty report is due. Lilly shall keep complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined.
7.6 Audits.
(a) Lilly will keep and maintain (and to the extent applicable, will cause its Affiliates, and their respective Sublicensees, distributors, assignees and transferees to keep and maintain) proper and complete records and books of account in such form and detail as is necessary for the determination of the amounts payable by Lilly (on behalf of itself and its Affiliates and their respective Sublicensees, distributors, assignees and transferees) to Hutchison under this Agreement and for the purposes of this Agreement.
(b) Upon the written request of Hutchison and not more than once in each Calendar Year, Lilly shall permit an independent certified public accounting firm of nationally
recognized standing selected by Hutchison and reasonably acceptable to Lilly, at Hutchisons expense, to have access during normal business hours to such of the records of Lilly as may be reasonably necessary to verify the accuracy of the royalty reports hereunder for any Calendar Year ending not more than thirty-six (36) months prior to the date of such request. Any given period may not be audited more than once. Hutchison may consider in good faith, at its sole discretion and choice, the use of Lillys then current external auditor to perform such audit. The accounting firm shall disclose to Hutchison and Lilly only whether the royalty reports are correct or incorrect and the specific details concerning any discrepancies. No other information shall be provided to Hutchison. This right to audit shall remain in effect throughout the life of this Agreement and for a period of three (3) years after the termination of this Agreement.
(c) If such accounting firm identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy within thirty (30) days of the date Hutchison delivers to Lilly such accounting firms written report so concluding, or as otherwise agreed upon by the Parties. The fees charged by such accounting firm shall be paid by Hutchison unless the underpayment exceeded the greater of [**] of the amount owed by Lilly to Hutchison for such Calendar Year or ii) [**], in which case, the expense of the audit shall be borne by Lilly. Lilly shall pay interest on the amounts owed to Hutchison, said interest shall be calculated as being [**] greater than the U.S. commercial prime rate as published by the Wall Street Journal on the date of the first discrepancy identified in the audit, and shall accrue from the date payments should have been made. In addition, Lilly shall pay to Hutchison any monetary penalties and/or interest incurred by Hutchison pursuant to Third Party Agreements, wherein said monetary penalties and/or interest are incurred due to underpayments by Lilly.
(d) Lilly shall include in each sublicense granted by it pursuant to this Agreement a provision requiring the Sublicensee to make reports to Lilly, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by Hutchison independent accountant to the same extent required of Lilly under this Agreement.
(e) Hutchison shall treat all financial information subject to review in accordance with the Article 10 of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with Lilly or its Related Parties obligating it to retain all such information in confidence pursuant to such confidentiality agreement.
7.7 Currency.
All payments to be made by one Party to the other under this Agreement shall be made in Renminbi ( RMB , ¥)) using the Conversion Rate from US$ to RMB by bank wire transfer from such Partys bank account in immediately available funds to the receiving Partys bank account designated in wiring by the Party receiving payment.
(i) to the extent costs, including Development Costs, are incurred in a currency other than RMB or a Product is sold in a currency other than RMB, the applicable expense or amount received shall be converted into RMB on a monthly basis using the Conversion Rate; and (ii) to the extent payments or Royalty Tiers are set forth in this Agreement in a currency
other than RMB, the applicable payment/Royalty Tier shall be converted into RMB using the Conversion Rate
7.8 T ax Withholding.
[**]
7.9 VAT .
It is understood and agreed between the Parties that any payments made under this Agreement are exclusive of any value added tax or similar sales tax (VAT), which shall be added thereon as applicable. Where VAT is properly added to a payment made under this Agreement, the Party making the payment will pay the amount of VAT only on receipt of a valid tax invoice issued in accordance with the laws and regulations of the country in which the VAT is chargeable.
7.10 Records.
Each Party shall maintain appropriate records in either tangible or electronic form of (a) all significant Development, Manufacturing and Commercialization (each as applicable) events and activities conducted by it or on its behalf related to a Product; and (b) all significant Information generated by it or on its behalf in connection with Development of Products under this Agreement, in each case in accordance with such Partys usual documentation and cGMP record retention practices. Such records shall be in sufficient detail to properly reflect, in good scientific manner, all significant work done and results of studies and trials undertaken and further shall be at a level of detail appropriate for patent and regulatory purposes. If reasonably necessary for a Party to perform its work under this Agreement or to exercise its rights under this Agreement, such Party may request that, and the other Party shall provide within a reasonable timeframe, such information and data regarding its activities hereunder as is reasonably available and reasonably related its activities under this Agreement; provided that neither Party shall be required to generate additional data or prepare additional reports to comply with the foregoing obligation. All such reports, Information and data provided shall be subject to the provisions of Article 10 .
7.11 Guarantees
(a) In consideration for Lilly entering into this Agreement, the Hutchison Guarantor irrevocably and unconditionally guarantees to Lilly the punctual performance of all obligations of Hutchison related to the payment of monies under this Agreement and undertakes to Lilly that whenever Hutchison does not pay any amount when due under or in connection with this Agreement, the Hutchison Guarantor shall immediately on demand pay that amount as if it was the principal obligor, so that the same benefits are conferred on Lilly as they would have received if such obligation had been performed and satisfied by Hutchison.
(b) The Hutchison Guarantor, as principal obligor and as a separate and
independent obligation and liability from its obligations and liabilities in Article 7.11(a) undertakes to indemnify and hold Lilly harmless from and against any loss or costs suffered or incurred by it as a result of the non-performance by Hutchison of any of its obligations under this Agreement. This guarantee is a continuing guarantee and will extend to the ultimate balance of sums payable by Hutchison under this Agreement, regardless of any intermediate payment or discharge in whole or in part.
(c) The obligations of a Guarantor will not be affected by any act, omission, matter or thing which, but for this Article 7.11, would reduce, release or prejudice any of its obligations under this Agreement including (i) any time, waiver or consent granted to a Party or any other person, (ii) the taking, variation, compromise, exchange, renewal or release of, or refusal or neglect to perfect, take up or enforce, any rights against a Party under this Agreement, (iii) the insolvency (or similar proceedings) of a Party, any incapacity or lack of power, authority or legal personality of a Party or change in control, ownership or status of a Party, (iv) any amendment to this Agreement (subject to such amendment not increasing the extent of the Guarantors liability under this Article 7.11 without the Guarantors consent), (v) any illegality, invalidity or unenforceability of any obligation of any person under this Agreement, or (vi) any other act, event or omission which might operate to discharge, impair or otherwise affect any of the obligations of the Guarantor or any of the rights, powers and remedies conferred on a Party under this Agreement. Each Guarantor waives any right which it may have to first require the a Party to proceed against the other Party before claiming from such Guarantor under this Article 7.11.
8. LICENSES; EXCLUSIVITY.
8.1 License to Lilly .
(a) Exclusive License and Right to Sublicense .
During the Term, Hutchison hereby grants Lilly an exclusive license (except as provided under Article 8.1(b)), royalty-bearing license, including the right to grant sublicenses, under Hutchisons Patents, Hutchison Know-How and Regulatory Approvals to Develop, use, import and Commercialize (but, for clarity, not to make or have made) Product(s) in the Field in the Territory.
(b) Hutchison Retained Rights.
Notwithstanding the rights granted to Lilly in Article 9.1(a), Hutchison retains the following the right to conduct Development activities assigned to Hutchison under the Development Plan .
8.2 No Implied Licenses.
Except as explicitly set forth in this Agreement, neither Party grants any license, express or implied, under its intellectual property rights to the other Party.
9. CONFIDENTIALITY; PUBLICATION .
9.1 Nondisclosure Obligation.
(a) For the Term of this Agreement and three years thereafter, the Party receiving the Confidential Information of the other Party (such receiving Party, the Receiving Party ) shall keep confidential and not publish, make available or otherwise disclose any Confidential Information to any Third Party, without the express prior written consent of the Party that disclosed such Confidential Information (the Disclosing Party ); provided however, the Receiving Party may disclose the Confidential Information to those of its Affiliates, officers, directors, employees, agents, consultants and/or independent contractors (including subcontractors and Third Party Manufacturers) of such Receiving Party who need to know the Confidential Information in connection with this Agreement and are bound by confidentiality obligations with respect to such Confidential Information. The Receiving Party shall exercise at a minimum the same degree of care it would exercise to protect its own confidential information (and in no event less than a reasonable standard of care) to keep confidential the Confidential Information. The Receiving Party shall use the Confidential Information solely in connection with the purposes of this Agreement.
(b) It shall not be considered a breach of this Agreement if the Receiving Party discloses Confidential Information in order to comply with a lawfully issued court or governmental order or with a requirement of Applicable Law or the rules of any internationally recognized stock exchange; provided that: (i) the Receiving Party gives prompt written notice of such disclosure requirement to the Disclosing Party and cooperates with Disclosing Partys efforts to oppose such disclosure or obtain a protective order for such Confidential Information, and (ii) if such disclosure requirement is not quashed or a protective order is not obtained, the Receiving Party shall only disclose those portions of the Confidential Information that it is legally required to disclose and shall make a reasonable effort to obtain confidential treatment for the disclosed Confidential Information.
9.2 Publications.
The JSC shall establish procedures for determining when publications, scientific presentations and the like relating to the Development of Products are appropriate and providing for review by the Parties of any publications to protect Confidential Information. The appropriateness of all publications relating to the Development or Commercialization of Products shall be determined by the JSC as a Mutual JSC Matter.
9.3 Publicity; Use of Names.
The Parties agree that the public announcements by the Parties of the execution of this Agreement shall be substantially in the form of the press release or releases attached as Exhibit D and shall the Parties cooperate in the issuance thereof as soon as practicable after the Effective Date unless otherwise agreed by the Parties. In addition, the Parties recognize that each Party may from time to time desire to issue additional press releases and make other public statements or disclosures regarding this Agreement or activities conducted hereunder and that such press releases, statements or disclosures may be issued upon prior written approval of the other Party, such approval not to be unreasonably withheld or delayed. The disclosing Party shall provide the other Party a copy of any such proposed disclosures at least
ten (10) Business Days prior to the proposed release and consider in good faith any comments the other Party may make, where practicable, and in light of any reporting obligations of such disclosing Party under Applicable Law or the rules of any internationally recognized stock exchange. Neither Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity or news release relating to this Agreement or its subject matter, without the prior express written permission of the other Party; provided however, that nothing herein shall prohibit the use of the trademark or trade name of a Product.
10. REPRESENTATIONS AND WARRANTIES.
10.1 Representations and Warranties of Hutchison.
Hutchison represents and warrants to Lilly that as of the Effective Date:
(a) it has the full right, power and authority to enter into this Agreement, to perform the Development, and to grant the licenses granted under Article 8, and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which Hutchison is bound;
(b) to the actual knowledge of Hutchison, there are no legal claims, judgments or settlements against or owed by Hutchison or pending legal claims or litigation, in each case relating to the Product;
(c) to the actual knowledge of Hutchison, there are no legal claims, judgments or settlements against or owed by Hutchison or pending legal claims or litigation, in each case relating to the Hutchison Patents;
(d) all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by Hutchison as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained;
(e) it Controls the right, title and interest in and to the Hutchison Patents and Hutchison Know-How, and has the right to grant to Lilly the licenses that it purports to grant hereunder and has not granted any Third Party rights that would interfere or be inconsistent with Lillys rights hereunder;
(f) to the best knowledge of Hutchison, the Hutchison Patents and Hutchison Know-How are not subject to any existing royalty or other payment obligations to any Third Party;
(g) it is not aware of any other Patents, Know How, or other intellectual property right Controlled by Hutchison or its Affiliates, other than that which is licensed hereunder to Lilly, which the Development, Manufacture, use and/or Commercialization of Products as contemplated hereunder would infringe;
(h) as of the Effective Date, to the actual knowledge of Hutchison, any issued Hutchison Patents are valid and enforceable and it is not aware of any action, suit, inquiry,
investigation or other proceeding threatened, pending, or ongoing brought by any Third Party that challenges or threatens the validity or enforceability of any of the Hutchison Patents; or except as already disclosed to Lilly, any Third Party that alleges the use of the Hutchison Patents or Hutchison Know-How or the Development, Manufacture Commercialization and use of the Products would infringe or misappropriate the intellectual property or intellectual property rights of any Third Party (and it has not received any notice alleging such an infringement or misappropriation). In the event that Hutchison becomes aware of any such action or proceeding, it shall immediately notify Lilly in writing;
(i) it has disclosed to Lilly a complete and accurate record of all material information and data relating to the results of all pre-clinical and clinical studies on Product conducted by or on behalf of Hutchison including the status and interim results of all ongoing clinical and preclinical studies, and the clinical development and Regulatory Approval activities undertaken to date, and all such information and data is complete and accurate in all material respects.
10.2 Representations and Warranties of Lilly.
Lilly represents and warrants to Hutchison that as of the Effective Date:
(a) it has the full right, power and authority to enter into this Agreement, to perform the Commercialization of the Product and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which Lilly is bound;
(b) all necessary consents, approvals and authorizations of all government authorities and other persons required to be obtained by Lilly as of the Effective Date in connection with the execution, delivery and performance of this Agreement have been obtained.
(c) Lilly does not have any current knowledge that would cause any of its representations or warranties to Hutchison to be incorrect or untrue.
10.3 No Other Representations or Warranties.
EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
11. INDEMNIFICATION .
11.1 By Lilly.
Lilly agrees to indemnify and hold harmless Hutchison, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the Hutchison Indemnitee(s) ) from and against all losses, liabilities, damages and expenses (including reasonable attorneys fees and costs) incurred in connection with any claims, demands, actions or other proceedings by any Third Party (individually and collectively, Losses ) first arising after the Effective Date to the extent arising from (a) the promotion, sale or other entry into the stream of commerce of defective Product due to the activities of Lilly, any of its Related Parties or Subcontractors, (b) the use by Lilly or any of its Related Parties or Subcontractors of Patents or Know-How Controlled by Lilly, (c) the negligence, illegal conduct or willful misconduct of Lilly, (d) Lillys breach of a ny of its representations or warranties made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement , or (e) Development activities if under Lillys sole control pursuant to this Agreement, in each case of clauses (a) through (e) except to the extent such Losses arise out of a Hutchison Indemnitees negligence, illegal conduct or willful misconduct, or breach of this Agreement.
11.2 By Hutchison.
Hutchison agrees to indemnify and hold harmless Lilly, its Affiliates, and their directors, officers, employees and agents (individually and collectively, the Lilly Indemnitee(s) ) from and against all Losses to the extent arising from (a) the Manufacture or supply of defective Product due to the activities of Hutchison, any of its Related Parties or Subcontractors, (b) the use by Hutchison or any of its Related Parties or Subcontractors of the Hutchison Patents or Hutchison Know-How, (c) the negligence, illegal conduct or willful misconduct of Hutchison, (d) Hutchisons breach of this Agreement, or (e) Development activities if under Hutchisons sole control pursuant to this Agreement, in each case of clauses (a)- (e), except to the extent such Losses arise out of any of a Lilly Indemnitees negligence, illegal conduct or willful misconduct, or breach of this Agreement.
11.3 Defined Indemnification Terms.
Either of the Lilly Indemnitee or the Hutchison Indemnitee shall be an Indemnitee for the purpose of this Article 11, and the Party that is obligated to indemnify the Indemnitee under Article 11.1 or Article 11.2 shall be the Indemnifying Party.
11.4 Defense.
If any such claims or actions are made, the Indemnitee shall be defended at the Indemnifying Partys sole expense by counsel selected by Indemnifying Party and reasonably acceptable to the Indemnitee, provided that the Indemnitee may, at its own expense, also be represented by counsel of its own choosing. The Indemnifying Party shall have the sole right to control the defense of any such claim or action, subject to the terms of this Article 11.
11.5 Settlement.
The Indemnifying Party may settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment (a) with prior written notice to the Indemnitee but without the consent of the Indemnitee where the only liability to the Indemnitee
is the payment of money and the Indemnifying Party makes such payment, or (b) in all other cases, only with the prior written consent of the Indemnitee, such consent not to be unreasonably withheld or delayed.
11.6 Notice.
The Indemnitee shall notify the Indemnifying Party promptly of any claim, demand, action or other proceeding under Article 11.1 or Article 11.2 and shall reasonably cooperate with all reasonable requests of the Indemnifying Party with respect thereto.
11.7 Permission by Indemnifying Party.
The Indemnitee may not settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment in any such action or other proceeding or make any admission as to liability or fault without the express written permission of the Indemnifying Party.
11.8 Limitation of Liability.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS ARTICLE 11.8 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE 11, OR DAMAGES AVAILABLE FOR A PARTYS BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9.
12. INVENTIONS; PATENT PROVISIONS .
12.1 Ownership of Intellectual Property .
(a) Hutchison shall remain the sole and exclusive owner of all Hutchison Patents and Hutchison Know-How. Lilly shall remain the sole and exclusive owner of any Lilly Know-How that Lilly Controlled as of the Effective Date or Controls during the Term (with the exception of Know-How owned jointly by Hutchison and Lilly as described in Article 12.1(b)).
(b) Hutchison shall own all data, results and inventions, whether patentable or not, conceived or reduced to practice in the course of conducting the Development of the Product or otherwise under this Agreement solely by Hutchison or its consultant or subcontractors, together with all intellectual property rights therein. Lilly shall own all data, results and inventions, whether patentable or not, conceived or reduced to practice in the course of conducting the Development of the Product or otherwise under this Agreement solely by Lilly or its consultant or subcontractor, together with all intellectual property rights therein. Hutchison and Lilly shall jointly own all data, results and inventions, whether patentable or not, conceived or reduced to practice by Hutchison and Lilly jointly, together with all intellectual property rights therein, with each Party owning an undivided half interest and the right to exploit without the consent of the other Party.
12.2 Patent Filing, Prosecution and Maintenance. Hutchison shall have sole decision-making authority for all actions relating to Hutchison Patents and Patents invented pursuant to activities conducted under this Agreement; provided that Lilly shall have sole decision-making authority for all actions relating to Patents invented pursuant to activities conducted under this Agreement invented solely by Lilly inventors or agents of Lilly (such Patents, the Lilly Patents ). The intellectual property subcommittee of the JSC shall have sole decision-making authority for all actions relating to Patents jointly owned by Hutchison and Lilly pursuant to activities conducted under this Agreement (such Patents, the Jointly Owned Patents ). Such actions include Patent Prosecution, defense, listing in regulatory publications (as applicable), patent term extension, abandonment, maintenance and enforcement, all of which will be conducted at Hutchisons sole expense. Hutchison shall establish an overall strategy for the filing, prosecution and maintenance of Hutchison Patents. Lilly shall establish an overall strategy for the filing, prosecution and maintenance of Lilly Patents. The intellectual property subcommittee shall establish an overall strategy for the filing, prosecution and maintenance of Jointly Owned Patents. The primary objective of such strategy shall be to provide patent exclusivity for the Products and uses thereof in the Territory. Hutchison shall keep the JSC and Lilly informed of the status of all actions taken in the Territory with respect to Hutchison Patents. Lilly shall keep the JSC and Hutchison informed of the status of all actions taken in the Territory with respect to Lilly Patents. The intellectual property subcommittee of the JSC shall keep Hutchison and Lilly informed of the status of all actions taken in the Territory with respect to Jointly Owned Patents. In particular, the informing entity shall (a) regularly and promptly provide the informed entities with copies of all prospective patent applications and patent applications filed hereunder and other material submissions and correspondence with government agencies concerning Hutchison Patents, Lilly Patents and any Jointly Owned Patents as applicable, in sufficient time to allow for review and comment by the informed entities; and (b) provide the informed entities and their patent counsels with an opportunity to consult with the informing entity and its patent counsel regarding the filing and contents of any such application, amendment, submission or response, and the advice and suggestions of the informed entity and its patent counsel shall be taken into consideration in good faith by the informing entity and its patent counsel.
12.3 Patent Oppositions .
The intellectual property subcommittee, in consultation with the Parties patent departments, will decide whether and how to participate in Patent oppositions and undertake activities intended to invalidate Third Party Patents when necessary; provided that in the event the intellectual property subcommittee is unable to make such decision due to a deadlock, each Party shall have final decision-making authority for decisions exclusively related to its solely owned Patents. The intellectual property subcommittee will keep the Parties informed and apprised of any such decisions and activities.
12.4 Costs of Patent Prosecution.
All costs for Patent Prosecution of Hutchison Patents shall be borne by Hutchison. All costs for Patent Prosecution of Lilly Patents shall be borne by Lilly. All costs of Patent Prosecution for Jointly Owned Patents shall be equally shared by the Parties. However, each of Hutchison and Lilly may in its sole discretion following consultation with the intellectual
property subcommittee elect to discontinue Patent Prosecution (and therefore, no longer pay the costs of such Patent Prosecution) in any country on a Patent-by-Patent basis as provided for under Article 12.2 above. Each Party shall give prompt notice to the other Party if it declines to pay costs for the filing, prosecution or maintenance of a Hutchison Patent, Jointly Owned Patent or Lilly Patent, as applicable, in any country of the Territory, and in such case, the other Party after consultation with notifying Party and with notifying Partys approval (which approval shall not be unreasonably withheld), shall have the right to file, prosecute or maintain such Patent at its own expense. If the Parties agree to allow the notified Party to file, prosecute or maintain a Patent pursuant to this Article 12.4, the notifying Party shall promptly deliver to the notified Party copies of all necessary files related to the Patent with respect to which responsibility has been transferred and shall take all actions and execute all documents reasonably necessary for the notified Party to assume such responsibility and to assign any Patents to the notified Party as necessary. As of the date of the notifying Partys assignment to the notified Party, such Patent shall not be included in the notifying Partys Patents, as applicable, under this Agreement.
12.5 Patent and Trademark Prosecution Cooperation.
With respect to all Patent Prosecution or Trademark prosecution each Party shall:
(a) execute any instruments to document their respective ownership consistent with this Agreement as reasonably requested by the other Party;
(b) make its employees, agents and consultants reasonably available to the other Party (or to the other Partys authorized attorneys, agents or representatives), to the extent reasonably necessary to enable the appropriate Party hereunder to undertake its Patent Prosecution responsibilities;
(c) cooperate, if necessary, with the other Party in gaining Patent term extensions; and
(d) act in good faith to coordinate its efforts under this Agreement with the other Party to minimize or avoid interference with the Patent Prosecution of the other Partys Patents to Products or Trademarks.
12.6 Enforcement .
(a) Notice.
Each Party shall promptly provide, but in no event later than thirty (30) days, to the other with written notice reasonably detailing any known or alleged infringement of any Patent owned or Controlled by either Party and subject to a license under this Agreement.
(b) Enforcement of Intellectual Property Rights.
The sole owner or Party Controlling a Patent, Know-How or Confidential Information shall have the right to institute and direct legal proceedings against any Third Party believed to be infringing such Patent or misappropriating or otherwise violating such Know-How or Confidential Information in the Territory; provided , however , that with respect to any such
infringement or violation of any Patent included in the Hutchison Patents or Jointly Owned Patents, Hutchison shall have the obligation, at its cost, to enforce such Patent and direct such legal proceedings. If Hutchison does not abate such violation of intellectual property rights of Hutchison Patents or Jointly Owned Patents, including by commencement of a lawsuit against the accused person if necessary, then Lilly shall be entitled (but shall not be obligated) to take all actions reasonably necessary to abate such violation, including commencement of a lawsuit against the accused person if necessary; provided, however, that Lilly shall consult in advance with Hutchison regarding such action and may not undertake any enforcement action without the prior approval of the JSC, such approval not to be unreasonably withheld. The primary objective of any patent enforcement action shall be to preserve exclusivity for the Product and uses thereof in the Territory. All amounts recovered from enforcement of any such rights by either Party relating to the intellectual property licensed under this Agreement shall be first used to reimburse each Partys costs and expenses incurred in connection with such action, and any remainder of such recovery shall be split in a manner consistent with the economic interests and lost profits of the Parties under the Agreement as agreed to by the Parties.
(c) Cooperation in Enforcement Proceedings.
For any action by a Party pursuant to subarticle (b) above, in the event that such Party is unable to initiate or prosecute such action solely in its own name, the other Party will join such action voluntarily and will execute all documents necessary for such Party to initiate, prosecute and maintain such action. If either Lilly or Hutchison initiates an enforcement action pursuant to Article 12.6(b), then the other Party shall cooperate to the extent reasonably necessary and at the first Parties sole expense (except for the expenses of the non-controlling Partys counsel, if any). Upon the reasonable request of the Party instituting any such action, such other Party shall join the suit and can be represented in any such legal proceedings using counsel of its own choice. Each Party shall assert and not waive the joint defense privilege with respect to all communications between the Parties reasonably the subject thereof.
12.7 Defense .
(a) Each Party shall notify the other in writing of any allegations it receives from a Third Party that the Manufacture, production, use, Development, Commercialization or distribution of any Product or any technology or intellectual property licensed by a Party under this Agreement infringes the intellectual property rights of such Third Party. Such notice shall be provided promptly, but in no event after more than ten (10) Business Days, following receipt of such allegations.
(b) In the event that a Party receives notice that it or any of its Affiliates have been individually named as a defendant in a legal proceeding by a Third Party alleging infringement of a Third Partys Patents or other intellectual property right as a result of the Manufacture, production, use, Development, Commercialization or distribution of Products or any technology or intellectual property licensed by a Party under this Agreement, such Party shall immediately notify the other Party in writing and in no event notify such other Party later than ten (10) Business Days after the receipt of such notice. Such written notice shall include a copy of any summons or complaint (or the equivalent thereof) received regarding the foregoing. Each Party shall assert and not waive the joint defense privilege with respect to all
communications between the Parties. In such event, the Parties shall agree how best to mitigate or control the defense of any such legal proceeding; and determine which Party it best suited to assume the primary responsibility for the conduct of the defense of any such claim at their expense. The other Party shall have the right, but not the obligation, to participate and be separately represented in any such suit at its sole option and at its own expense. Each Party shall reasonably cooperate with the Party conducting the defense of the claim. If a Party or any of its Affiliates have been individually named as a defendant in a legal proceeding relating to the alleged infringement of a Third Partys Patents or other intellectual property right as a result of the Manufacture, production, use, Development, Commercialization or distribution of Products, then that Party shall conduct the defense and the other Party shall be allowed to join in such action, at its own expense.
(c) Status; Settlement . The Parties shall keep each other informed of the status of and of their respective activities regarding any infringement litigation initiated by a Third Party concerning a Partys Manufacture, production, use, Development, Commercialization or distribution of Products or settlement thereof; provided , however , that no settlement or consent judgment or other voluntary final disposition of a suit under this Article 12.7(c) may be undertaken by a Party without the consent of the other Party which consent shall not be unreasonably withheld or delayed.
(d) Notwithstanding anything to the contrary in this Article 12.7, if a Party is an Indemnifying Party with respect to any Losses stemming from a claim or action by a Third Party alleging infringement of a Third Partys Patents or other intellectual property right as a result of the Manufacture, production, use, Development, Commercialization or distribution of Products or any technology or intellectual property licensed by a Party under this 3, Article 11 shall supersede this Article 12.7 with respect to the defense and settlement of such action or claim to the extent there are conflicts.
13. TERMS AND TERMINATION .
13.1 Term and Expiration.
This Agreement shall be effective as of the Effective Date and unless terminated earlier pursuant to Articles 3.4(b), 7.1(c), 13.2 or 13.3, shall continue in effect until the earlier of (i) the expiration of all earned royalty payment obligations as defined under Article 7.3(b) or (ii) when Generic Competition for all Products grows to the point where the total market sales of Generic Product exceeds [**] in the Territory (the Term ). Upon the natural expiration of this Agreement as contemplated in this Article 13.1, Lillys licenses granted under this Agreement shall become fully paid-up, non-exclusive perpetual licenses.
13.2 Unilateral Termination by Lilly .
Lilly shall have the right to terminate this Agreement in its entirety on a worldwide basis or, if applicable, on a country-by-country basis, in its sole discretion by giving one hundred and twenty (120) days advance written notice to Hutchison.
13.3 Termination for Cause.
This Agreement may be terminated at any time during the Term upon written notice by (i) either Party if the other Party is in breach of its payment obligations under this Agreement that has not been cured within fifteen (15) Business Days after notice requesting cure of such breach, (ii) either Party if the other Party is in material breach of any of its non-payment obligations under this Agreement that has not been cured within ninety (90) days after notice requesting cure of such breach; provided, however, that if such breach is not reasonably subject to cure within ninety (90) days, subject to Commercially Reasonable Efforts (which in no event shall be less than reasonably diligent efforts) being undertaken by the breaching Party throughout such 90-day period and thereafter to cure such breach as promptly as possible, the Agreement may not be terminated pursuant to this Article 13.3 unless such breach is not cured within nine (9) months following notice requesting cure of such breach.
13.4 Termination for Major Unexpected Safety Issue.
This Agreement may be terminated in its entirety upon one hundred and twenty (120) days written notice by Lilly to Hutchison if Lilly determines reasonably and in good faith that there is a Major Unexpected Safety Issue with respect to a Product in an Initial Indication; provided that such notice must be delivered by Lilly to Hutchison within the thirty (30) day JSC review period referenced in Article 3.4(a) in order for such notice to be effective. Following the issue of such notice of termination in accordance with this Article 13.4, no further milestone payments shall be due and payable by Lilly and Lilly shall not be obligated to fund or pay any Subsequent Development Costs.
13.5 Effect of Termination.
(a) If Lilly terminates this Agreement pursuant to Article 13.2 or Article 13.4 or if Hutchison terminates the Agreement pursuant to Article 13.3 or Article 15.2(a), then:
(i) Lilly shall transfer to Hutchison as soon as practicable, and in accordance with Subparagraph (iv) below, all regulatory materials and other information necessary to the Product as promptly as practicable so as to permit Hutchison to continue Development efforts with respect to Product should Hutchison elect to do so. In addition, for a period of ninety (90) days from the effective date of termination, Lilly will without charge provide such consultation or other assistance, not to exceed sixty (60) hours annually, as Hutchison may reasonably request to assist Hutchison in becoming familiar with such regulatory materials and the like in order that Hutchison may prepare to undertake further Development and Commercialization of the Product.
(ii) The right to Develop and Commercialize Products shall be reverted to Hutchison and the license granted to Lilly under Article 9.1 shall terminate. Lilly shall grant and hereby grants Hutchison, effective as of the date of termination, a perpetual, worldwide, fully paid,
royalty-free, sublicenseable, non-exclusive license under any Patents or Know-How Controlled by Lilly (including the Lilly Patents) and Jointly Owned Patents as they same exist as of the effective date of termination, that are necessary to make, have made, use, sell, offer for sale and import Products.
(iii) Unless Lilly and Hutchison agree otherwise, all activities underway at the time of termination shall be transferred to Hutchison or terminated as soon as possible except that Lilly will continue to be responsible for any pre-clinical or clinical studies to the extent that Lillys then current ethical guidelines would require Lilly to complete such studies. All costs of continuing trials for ethical reasons or winding down activities shall continue to be borne by the Parties as provided in this Agreement until completion of such activities. For the sake of clarity, the costs of winding down activities shall include any incurred costs or otherwise unavoidable wind down costs that would otherwise have been payable by Lilly and the costs of continuing trials for ethical reasons shall be the costs, if any, to continue treatment of current patients under treatment in the trial in accordance with Lillys ethical guidelines.
(iv) In the event of termination of this Agreement, the intent and primary goal of the Parties shall be the efficient and effective transfer of all necessary information, legal rights, knowledge, and materials so as to minimize delay in execution of the Development Plan and Commercialization efforts as it existed prior to notice of termination.
(b) If either Party has the right to terminate this Agreement under Article 13.3, it may at its sole option, elect either to (i) terminate this Agreement and pursue any legal or equitable remedy available to it or (ii) maintain the Agreement in effect and pursue any legal or equitable remedy available to it.
13.6 Survival.
The following provisions shall survive the termination or expiration of this Agreement for any reason: Articles 1, 3.5 (with respect to Development Costs incurred prior to the effective date of termination), 7 (to the extent payments have accrued, and with respect to payments that have accrued, prior to the effective date of termination), 9 (except that all activities or decisions for which the JSC is responsible pursuant to Article 9.2 shall be conducted or made by the mutual agreement of the Parties), 10, 11, 13.1, 13.5, 13.6, 14 and 15.
14. DISPUTE RESOLUTION
14.1 Disputes .
The Parties recognize that disputes as to certain matters may from time to time arise which relate to either Partys rights or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of such disputes in an expedient manner by mutual cooperation; however, should a dispute arise, except for a dispute regarding the payment or non-payment of a payment, milestone or royalty under Articles 7 or 14, the Parties agree to follow the arbitration procedures set forth in Article 14.2. For disputes relating to the payment or non-payment of a payment, milestone or royalty under Articles 7 or 14, after the Parties fail to resolve the dispute through good faith negotiations then each Party shall be free to choose an alternative course of resolution including litigation.
14.2 Arbitration Procedures .
In the event of a dispute, that cannot be resolved through good faith negotiations as set forth above, the dispute shall be referred to and finally resolved by arbitration in the following manner:
(i) The dispute shall be settled by arbitration in Hong Kong by the Hong Kong International Arbitration Centre (the HKIAC ) in accordance with the Hong Kong International Arbitration Centre Administered Arbitration Rules (the HKIAC Rules ) in force when the Arbitration Notice is submitted in accordance with the HKIAC Rules. There shall be three (3) arbitrators.
(ii) The arbitral proceedings shall be conducted in English. To the extent that the HKIAC Rules are in conflict with the provisions of this Article 15.2, including the provisions concerning the appointment of the arbitrator, the provisions of this Article 15.2 shall prevail.
(iii) Each Party to the arbitration shall cooperate with each other Party to the arbitration in making full disclosure of and providing complete access to all information and documents requested by such other Party in connection with such arbitral proceedings, subject only to any confidentiality obligations binding on such Party.
(iv) The award of the arbitral tribunal shall be final and binding upon the Parties a party thereto, and the prevailing Party may apply to a court of competent jurisdiction for enforcement of such award.
(v) Any Party that is a party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.
14.3 Consent to Jurisdiction. Subject to Articles 14.1 and 14.2, each Party to this Agreement, by its execution hereof, (a) hereby irrevocably submits to the exclusive jurisdiction of the Supreme Court of the State of New York, New York County and the United States District Court for the Southern District of New York (collectively, the Courts ) for the purpose of any and all actions, suits or proceedings arising in whole or in part out of,
related to, based upon or in connection with this Agreement or the subject matter hereof, (b) hereby waives to the extent not prohibited by Applicable Law, and agrees not to assert, by way of motion, as a defense or otherwise, in any such action, any claim that it is not subject personally to the jurisdiction of the Courts, that its property is exempt or immune from attachment or execution, that any such action brought in one of the Courts should be dismissed on grounds of forum non conveniens, should be transferred to any court other than one of the Courts, or should be stayed by reason of the pendency of some other proceeding in any other court other than one of the Courts, or that this Agreement or the subject matter hereof may not be enforced in or by such Court, and (c) hereby agrees not to commence any such action other than before one of the Courts nor to make any motion or take any other action seeking or intending to cause the transfer or removal of any such action to any court other than one of the Courts whether on the grounds of inconvenient forum or otherwise. Each Party further agrees that service or any process, summons, notice or document by U.S. registered mail to such Partys notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in New York with respect to any matters to which it has submitted to jurisdiction in this Article 14.3.
15. MISCELLANEOUS .
15.1 Force Majeure.
Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any Governmental Authority. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all Commercially Reasonable Efforts necessary to cure such force majeure circumstances.
15.2 Assignment or Change of Control.
(a) Except as otherwise set forth in this Agreement, this Agreement and its rights, privileges, and obligations may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided that either Party may assign, without consent but with prior written notice, such Partys rights and obligations under this Agreement (i) in connection with a merger, consolidation, or sale of substantially all of the assigning Partys assets to an unrelated Third Party, (ii) in connection with a Change of Control, or (iii) to an Affiliate of such Party provided that in the case of an assignment by Lilly to a Lilly Affiliate, if such Lilly Affiliate fails to perform its responsibilities under the Agreement, then Lilly shall remain liable in all respects under this Agreement notwithstanding any assignment of the Agreement to such Affiliate; provided that, in the event of an assignment described in clause (i) or (ii), the non-assigning Party may at its sole discretion terminate this Agreement if such Change of Control reasonably presents a conflict of interest to continue with the successor entity. For the purposes of this Agreement, a Change of Control of a Party occurs upon (i) the
closing of a sale of all or substantially all of the assets of such Party to a Third Party in one transaction or series of transactions, (ii) the closing of a merger or other business combination or transaction that results in a Third Party owning, directly or indirectly, of more than 50% of the voting securities of such Party, or (iii) the closing of a transaction, following which a Third Party acquires direct or indirect ability or power to direct or cause the direction of the management and policies of such Party or otherwise direct the affairs of such Party, whether through ownership of equity, voting securities, beneficial interest, by contract, or otherwise, provided that for the purposes of this Agreement, a Change in Control shall not be deemed to have taken place if such Change of Control transaction involves a reorganization or similar transaction amongst the direct or indirect shareholders or Affiliates of such Party, following which a shareholder or Affiliate of such Party emerges as the direct or indirect owner of more than 50% of the voting securities, or owning all or substantially all the assets of the Party, or acquiring the direct or indirect ability or power to direct or cause the direction of the management and policies of such Party. Any assignee must assume in writing the obligations of the assigning Party to which it is the assignee or successor. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.
(b) A Party terminating pursuant to Article 15.2(a) must deliver three (3) months prior written notice within nine (9) months of the delivery of notice by the assigning Party of the effectiveness of such assignment.
15.3 Severability.
If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
15.4 Notices.
All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
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Hutchison MediPharma Limited Building 4, 720 Cailun Road Zhangjiang High Tech Park Shanghai, China 201203 Attn: Chief Executive Officer, Hutchison MediPharma Limited Fax: + 86-21-50793900 |
or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a Business Day; (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (c) on the fifth Business Day following the date of mailing if sent by mail.
15.5 Applicable Law and Litigation.
All questions of inventorship will be determined in accordance with U.S. patent laws. In respect to all other Patent issues, the rights of the Parties will be governed by the laws of the jurisdiction in which the applicable Patent is filed or granted. In all other respects, this Agreement shall be governed by and construed in accordance with the laws of New York without reference to any rules of conflict of laws.
15.6 Entire Agreement; Amendments.
The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. The Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.
15.7 Headings.
The captions to the several Articles hereof are not a part of the Agreement, but are merely for convenience to assist in locating and reading the Articles and Articles of this Agreement.
15.8 Independent Contractors.
It is expressly agreed that Hutchison and Lilly shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Hutchison nor Lilly 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.
15.9 Waiver.
The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.
15.10 Waiver of Rule of Construction.
Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
15.11 Construction.
Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the
singular shall be deemed to include the plural (and vice versa), (b) the words include, includes and including shall be deemed to be followed by the phrase without limitation, (c) the word will shall be construed to have the same meaning and effect as the word shall, (d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person shall be construed to include the persons successors and assigns, (f) the words herein, hereof and hereunder, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Articles or Exhibits shall be construed to refer to Articles or Exhibits of this Agreement, and references to this Agreement include all Exhibits hereto, (h) the word notice means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder agree, consent or approve or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term or shall be interpreted in the inclusive sense commonly associated with the term and/or.
15.12 Counterparts.
The 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. Each Party shall be entitled to rely on the delivery of executed facsimile copies of counterpart execution pages of this Agreement and such facsimile copies shall be legally effective to create a valid and binding agreement among the parties.
[signature pages follow]
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
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Exhibit A, Hutchison Patents
HMPL-013 Fruquintinib Intellectual Property Summary
Intellectual properties regarding Hutchisons Fruquintinib product include patents/applications and secret know-how. Below is a brief summary of Hutchisons position in one area.
Granted or Pending Patent Applications
Patent and patent applications in the Territory relating to the Fruquintinib product are summarized in the following Table:
[**]
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Secret know-how
Trade secrets exist and continue to be developed regarding Fruquintinib.
Exhibit B, Initial Development Plan and Costs (Page 5 of 8)
Lilly Full Time Equivalent (FTE) Costs: (FTE) Costs:(Global FTE rate [**]/yr, China FTE rate [**]/yr, CRP FTE rate [**]/yr)
Exhibit B, Initial Development Plan and Costs (Page 6 of 8)
Hutchison Full Time Equivalent (FTE) Costs: (FTE) Costs:(Global FTE rate [**]/yr, China FTE rate [**]/yr, CRP FTE rate [**]/yr)
Exhibit B, Initial Development Plan and Costs (Page 7 of 8)
Grand Total Initial Development Plan Costs: (FTE) Costs:(Global FTE rate [**]/yr, China FTE rate [**]/yr, CRP FTE rate [**]/yr)
[**]
Exhibit B, Initial Development Plan and Costs (Page 8 of 8)
Development Costs for 3 rd Line NSCLC Initial Indication as referenced in Article 3.4(c)(aa): (FTE) Costs:(Global FTE rate [**]/yr, China FTE rate [**]/yr, CRP FTE rate [**]/yr)
[**]
Exhibit C, Positive POC Thresholds for Initial Indications
3 rd Line Colorectal Cancer:
a) Study Design
i. [**].
ii. [**].
b) Positive POC Thresholds:
i. [**]; or
ii. [**]; and
iii. [**].
2 rd Line Advanced Gastric Cancer:
a) Study Design
i. [**].
ii. [**].
b) Positive POC Thresholds:
i. [**]; or
ii. [**]; and
iii. [**].
Exhibit C, Positive POC Thresholds for Initial Indications (Page 2 of 2)
3 rd Line Non Small Cell Lung Cancer:
a) Study Design
[**]
ii. [**]
b) Positive POC Thresholds:
i. [**]; or
ii. [**]; and
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Hutchison China MediTech Limited
(Chi-Med) (AIM: HCM)
Exhibit D, Press Release
Chi-Med Announces Cancer Therapy Collaboration with Lilly
London: [ ], [ ] [ ] 2013: Hutchison MediPharma Limited (HMP), an R&D company majority owned by Chi-Med, today announced that it has entered into a licensing, co-development, and commercialization agreement in China with Eli Lilly and Company (Lilly) for Fruquintinib (HMPL-013), a targeted oncology therapy for the potential treatment of various types of solid tumors. Fruquintinib, a selective inhibitor of the Vascular Endothelial Growth Factor (VEGF) receptor tyrosine kinases, was discovered by HMP and is currently in Phase II testing in China.
Under the terms of the agreement, the costs of future development of Fruquintinib in China, to be carried out by HMP, will be shared between HMP and Lilly. HMP will potentially receive a series of payments of up to US$86.5 million, including upfront payments, and development and regulatory approval milestones. Should Fruquintinib be successfully commercialized in China, HMP would receive tiered royalties starting in the mid-teens percentage of net sales. Additional terms of the agreement were not disclosed.
Christian Hogg, Chief Executive Officer of Chi-Med said: Our belief is that Fruquintinib has potential activity against multiple tumor types with high incidence rates and may benefit patients with significant unmet medical needs in China. The collaboration with Lilly will allow for Fruquintinib to be developed across various tumor types in China and at a far greater speed than if we went alone.
We are excited to collaborate with Hutchison MediPharma in the development of this potential new cancer therapy, said Jacques Tapiero, Lilly Senior Vice President and President of Emerging Markets. In Lillys emerging markets business, we are focused on providing patients with innovative medicines from our own pipeline and through collaborations with respected science-based companies such as HMP. Together, we are committed to help meet the medical needs of oncology patients in China.
About Fruquintinib
Fruquintinib (HMPL-013) is a novel and potent small molecule agent that selectively inhibits VEGFR 1, 2 and 3. In preclinical studies, Fruquintinib has shown potent inhibitory effects on multiple human tumor xenografts. In the initial single arm Phase I study in advanced refractory solid tumors, Fruquintinib has demonstrated excellent pharmacokinetic properties and was well tolerated. In addition, it demonstrated clinical activity in patients with various heavily pre-treated advanced cancers. Currently, a single arm Phase II study for Fruquintinib is on-going in China with results expected to be released in early 2014. In July 2013, HMP received Phase II/III Clinical Trial Application approval from the China Food and Drug Administration which granted the further development of fruquintinib. In the planned Phase II/III clinical trials, Fruquintinib will be studied in patients with a variety of solid tumors.
About Hutchison MediPharma
Hutchison MediPharma is a novel drug R&D company focusing on discovering, developing and commercializing innovative therapeutics in oncology and autoimmune diseases. With a team of around 200 scientists and staff, its pipeline is comprised of novel oral compounds for cancer and inflammation in development in North America,
Europe, Australia and Greater China.
Hutchison MediPharma is majority owned by Chi-Med. For more information please
visit: www.hmplglobal.com
About Chi-Med
Chi-Med is the holding company of a healthcare group based primarily in China and was listed on the Alternative Investment Market of the London Stock Exchange in May 2006. It is focused on researching, developing, manufacturing and selling pharmaceuticals and health oriented consumer products. Chi-Med is majority owned by Hutchison Whampoa Limited, an international company listed on the Main Board of the Stock Exchange of Hong Kong Limited. For more information please visit: www.chi-med.com
Enquiries
Chi-Med |
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+ 852 2121 8200 |
Christian Hogg, CEO |
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Citigate Dewe Rogerson |
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+44 20 7638 9571 |
Anthony Carlisle |
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+44 7973 611 888 |
David Dible |
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+44 7967 566 919 |
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Panmure Gordon (UK) Limited |
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+44 20 7886 2500 |
Richard Gray |
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Andrew Potts |
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THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
OPTION AGREEMENT
between
HUTCHISON CHINA MEDITECH LIMITED
and
ELI LILLY AND COMPANY
OPTION AGREEMENT
This Agreement (the Agreement ), effective as of 8 th October 2013 (the Effective Date ), is entered into by and among Hutchison China MediTech Limited, a company organized and existing under the laws of the Cayman Islands with its principal offices at PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands ( Hutchison ) and Eli Lilly and Company, an U.S.A. company, organized and existing under the laws of the State of Indiana, having a place of business at Lilly Corporate Center, Indianapolis, Indiana 46285 U.S.A( Lilly ). Hutchison and Lilly may be referred to herein individually as a Party or collectively as the Parties. Reference to a Party shall be deemed to include that Partys Affiliates.
Recitals:
A. Hutchisons Affiliate owns the molecule HMPL-013 and is developing it for the Chinese market as a pharmaceutical product useful in the treatment of cancer.
B. Lilly is a pharmaceutical company having expertise in the discovery, development, manufacturing and commercialization of innovative human pharmaceutical products, including cancer products.
C. Lilly and Hutchison MediPharma Limited, a subsidiary of Hutchison, have, pursuant to the Exclusive License and Collaboration Agreement dated as of the Effective Date (the Collaboration Agreement ), entered into a collaboration under which Lilly would obtain exclusive rights in the Field in the Territory to the Hutchison developmental stage pharmaceutical product, the cancer compound known as HMPL-013.
D. Hutchison desires to grant, and Lilly desires to receive, exclusive option rights to expand the Territory with respect to which Lilly has rights in the Field to HMPL-013 on the terms set forth in this Agreement.
In consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
Agreement:
1. DEFINITIONS .
Unless specifically set forth to the contrary herein, capitalized terms in this Agreement shall have the meaning set forth in the Collaboration Agreement and if no meaning for a capitalized term is set forth in the Collaboration Agreement, such term, whether used in the singular or plural, shall have the respective meaning set forth below:
1.1 Agreement shall have the meaning set forth in the introduction to this agreement.
1.2 Change of Control shall have the meaning set forth in Article 8.2(a).
1.3 Development Option shall have the meaning set forth in Article 2.4.
1.4 Effective Date shall have the meaning set forth in the introduction in this Agreement.
1.5 Global Option shall have the meaning set forth in Article 2.1.
1.6 Global Option Exercise Amount shall have the meaning set forth in Article 2.1.
1.7 Global Option Exercise Period shall have the meaning set forth in Article 2.1.
2. GLOBAL OPTION
2.1 Overview .
Hutchison hereby grants to Lilly an exclusive global Development and Commercialization option ( Global Option ) for the Product to expand the Territory beyond China and Hong Kong to include some or all additional countries in the world as mutually agreed by the Parties. For each Product, Lilly will have the opportunity to exercise the Global Option during the Global Option Exercise Period and the option exercise amount (the Global Option Exercise Amount ) will vary depending on when Lilly exercises such Global Option, as follows:
Time Period in which Global Option is
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For the purposes of the table above, Completion is the date upon which all data for the specified study that is reasonably necessary to inform Lillys analysis of the relevant option is made available to Lilly. Lilly may exercise the Global Option (via a written notice to Hutchison) at any time after such Products Colorectal Cancer proof of concept Study Completion and on or prior to [**] after such Products Non-Small Cell Lung Cancer Phase III Study Completion (such time period, the Global Option Exercise Period ). The Global Option for the Product will terminate upon the earlier of (a) the date upon which Lilly elects not to conduct Subsequent Development of such Product pursuant to Article 3.4(a)(iii) of the Collaboration Agreement or an election is otherwise made pursuant to the Collaboration Agreement to no longer pursue Development of such Product under this Agreement and (b) the end of such Products Global Option Exercise Period.
2.2 Global Option, Development and Commercialization .
From the time that Lilly notifies Hutchison that it intends to exercise the Global Option with respect to the Product during the Global Option Exercise Period, the Parties will negotiate in good faith, for a period of up to four (4) months (or a longer period as mutually agreed upon
by the Parties), an agreement and which will among other things expand the Territory to include the relevant countries (Global Development and Commercialization License Agreement). Any Global Development and Commercialization License Agreement shall include the following financial terms; provided that, notwithstanding anything to the contrary in this Agreement , the Parties acknowledge that financial terms in clauses (c) and (d) are based on the assumption that Lilly exercises the Global Option on a worldwide basis, and, if Lilly does not exercise the Global Option on a worldwide basis, such financial terms below shall be subject to discussion and re-evaluation by the Parties:
(a) The relevant Global Option Exercise Amount for such Products Global Option will be paid by Lilly to Hutchison within [**] of execution of such Global Development and Commercialization License Agreement.
(b) A Regulatory Approval Milestone for the first Product approved in the following locations which shall be payable only once as follows:
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(c) An annual, cumulative, worldwide (excluding Chinas and Hong Kongs Net Sales) Net Sales milestone for Product which shall be payable only once the first time the milestones Net Sales amount is achieved as follows:
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A milestone in clauses (b) or (c) above will be paid within [**] days of the occurrence of the described event.
(d) Tiered, earned royalties on the annual Net Sales of Product in all countries in the expanded Territory (excluding China and Hong Kong) in the amounts set forth below (all amounts are in U.S. dollars).
Annual Product Net
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The above tiered royalties are calculated such that the higher tiered royalties are only paid after the annual Net Sales exceed the top threshold of the previous tier. All earned royalties will be calculated and paid pursuant to Article 7 of the Collaboration Agreement.
2.3 Other Global Option Considerations.
(a) The Global Development and Commercialization License Agreement shall include Lillys right to take over the Manufacturing responsibilities for the relevant Product(s) in the expanded Territory and/or original Territory under terms to be negotiated and mutually agreed upon by the Parties.
(b) For those countries in the expanded Territory that accept Regulatory Approval documentation from China, Hutchison will provide Lilly with such regulatory documentation and dossiers and provide reasonable support to Lilly in its interactions with Regulatory authorities within the expanded Territory countries.
2.4 Limited Global Development Option
At any time prior to the expiry of the Global Option Exercise Period for Product under Article 2.1, Lilly may exercise a global development option for such Product ( Development Option ) by paying Hutchison [**] . Upon exercise of a Development Option for the Product, Hutchison will, for the duration of the Global Option Exercise Period for such Product, grant Lilly a fully paid-up, non-exclusive limited license, without the right to sublicense, under Hutchison Patents and the Hutchison Know-How as of such time, without a right to Commercialize, to Develop such Product in the Field outside the Territory. Lilly may then, at its sole discretion, conduct pre-clinical and clinical Development studies in the Field outside the Territory for such Product. In the event that Lilly does not exercise the Global Option for the Product within such Products Global Option Exercise Period, Hutchison may, at its discretion, purchase the data produced by Lilly under the Development Option for an amount not to exceed Lillys incurred Development costs in developing the data.
2.5 Transfer of Safety and Regulatory Agreement.
Exercising the Global Option or the Development Option, provided in Articles 2.3 and 2.4 will trigger the transfer of safety responsibilities from Hutchison to Lilly. Prior to the transfer, representatives from each Party will meet to develop a safety and regulatory agreement for the exchange of these responsibilities, the global safety data base and related data and documents.
3. CONFIDENTIALITY; PUBLICATION .
3.1 Nondisclosure Obligation .
(a) For the Term of this Agreement and three years thereafter, the Receiving Party shall keep confidential and not publish, make available or otherwise disclose any Confidential Information to any Third Party, without the express prior written consent of the Disclosing Party; provided however, the Receiving Party may disclose the Confidential Information to those of its Affiliates, officers, directors, employees, agents, consultants and/or independent contractors of such Receiving Party who need to know the Confidential Information in connection with this Agreement and are bound by confidentiality obligations with respect to such Confidential Information. The Receiving Party shall exercise at a minimum the same degree of care it would exercise to protect its own confidential information (and in no event less than a reasonable standard of care) to keep confidential the Confidential Information. The Receiving Party shall use the Confidential Information solely in connection with the purposes of this Agreement.
(b) It shall not be considered a breach of this Agreement if the Receiving Party discloses Confidential Information in order to comply with a lawfully issued court or governmental order or with a requirement of Applicable Law or the rules of any internationally recognized stock exchange; provided that: (i) the Receiving Party gives prompt written notice of such disclosure requirement to the Disclosing Party and cooperates with Disclosing Partys efforts to oppose such disclosure or obtain a protective order for such Confidential Information, and (ii) if such disclosure requirement is not quashed or a protective order is not obtained, the Receiving Party shall only disclose those portions of the Confidential Information that it is legally required to disclose and shall make a reasonable effort to obtain confidential treatment for the disclosed Confidential Information.
3.2 Publications .
Hutchison shall determine when publications, scientific presentations and the like relating to the Development of Products under this Agreement are appropriate.
3.3 Publicity; Use of Names .
The Parties recognize that each Party may from time to time desire to issue press releases and make other public statements or disclosures regarding this Agreement or activities conducted hereunder and that such press releases, statements or disclosures may be issued upon prior written approval of the other Party, such approval not to be unreasonably withheld or delayed.
4. REPRESENTATIONS AND WARRANTIES.
4.1 Representations and Warranties of Hutchison .
Hutchison represents and warrants to Lilly that, as of the Effective Date, it has the full right, power and authority to enter into this Agreement and to grant the rights granted under Article 2, and the fulfillment of its obligations and performance of its activities hereunder do not
materially conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which Hutchison is bound.
4.2 Representations and Warranties of Lilly .
Lilly represents and warrants to Hutchison that, as of the Effective Date, it has the full right, power and authority to enter into this Agreement and the fulfillment of its obligations and performance of its activities hereunder do not materially conflict with, violate, or breach or constitute a default under any material contractual obligation or court or administrative order by which Lilly is bound;
4.3 No Other Representations or Warranties .
EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY. ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
5. INDEMNIFICATION .
5.1 By Lilly .
Lilly agrees to indemnify and hold harmless the Hutchison Indemnitee(s) from and against all Losses first arising after the Effective Date to the extent arising from (a) the negligence, illegal conduct or willful misconduct of Lilly, (b) Lillys breach of a ny of its representations or warranties made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement , or (c) development activities with respect to a Product conducted by Lilly after exercise of the Development Option, in each case of clauses (a) through (c) except to the extent such Losses arise out of a Hutchison Indemnitees negligence, illegal conduct or willful misconduct, or breach of this Agreement.
5.2 By Hutchison .
Hutchison agrees to indemnify and hold harmless the Lilly Indemnitees from and against all Losses to the extent arising from (a) the negligence, illegal conduct or willful misconduct of Hutchison, or (b) Hutchisons breach of a ny of its representations or warranties made in or pursuant to this Agreement or any covenants or obligations set forth in or entered into pursuant to this Agreement , in each case of clauses (a)- (b), except to the extent such Losses arise out of any of a Lilly Indemnitees negligence, illegal conduct or willful misconduct, or breach of this Agreement.
5.3 Defined Indemnification Terms .
Either of the Lilly Indemnitee or the Hutchison Indemnitee shall be an Indemnitee for the purpose of this Article 5, and the Party that is obligated to indemnify the Indemnitee under Article 5.1 or Article 5.2 shall be the Indemnifying Party.
5.4 Defense .
If any such claims or actions are made, the Indemnitee shall be defended at the Indemnifying Partys sole expense by counsel selected by Indemnifying Party and reasonably acceptable to the Indemnitee, provided that the Indemnitee may, at its own expense, also be represented by counsel of its own choosing. The Indemnifying Party shall have the sole right to control the defense of any such claim or action, subject to the terms of this Article 5.
5.5 Settlement .
The Indemnifying Party may settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment (a) with prior written notice to the Indemnitee but without the consent of the Indemnitee where the only liability to the Indemnitee is the payment of money and the Indemnifying Party makes such payment, or (b) in all other cases, only with the prior written consent of the Indemnitee, such consent not to be unreasonably withheld or delayed.
5.6 Notice .
The Indemnitee shall notify the Indemnifying Party promptly of any claim, demand, action or other proceeding under Article 5.1 or Article 5.2 and shall reasonably cooperate with all reasonable requests of the Indemnifying Party with respect thereto.
5.7 Permission by Indemnifying Party .
The Indemnitee may not settle any such claim, demand, action or other proceeding or otherwise consent to an adverse judgment in any such action or other proceeding or make any admission as to liability or fault without the express written permission of the Indemnifying Party.
5.8 Limitation of Liability.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS ARTICLE 5.8 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER ARTICLE 5, OR DAMAGES AVAILABLE FOR A PARTYS BREACH OF CONFIDENTIALITY OBLIGATIONS UNDER THE COLLABORATION AGREEMENT.
6. TERM AND TERMINATION
6.1 Term. This Agreement shall be effective as of the Effective Date and shall terminate on the earlier of (a) the end of the Term of the Collaboration Agreement, (b) the date on which the Global Option terminates pursuant to Article 2.1.
6.2 Survival . The following provisions shall survive the termination or expiration of this Agreement for any reason: Article 1, Article 2 (to the extent payments have accrued, and with respect to payments that have accrued, prior to the effective date of termination), Articles 3, 4 and 5.
7. DISPUTE RESOLUTION
7.1 Disputes.
The Parties recognize that disputes as to certain matters may from time to time arise which relate to either Partys rights or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of such disputes in an expedient manner by mutual cooperation; however, should a dispute arise, the Parties agree to follow the arbitration procedures set forth in Article 7.2.
7.2 Arbitration Procedures.
In the event of a dispute, that cannot be resolved through good faith negotiations as set forth above, the dispute shall be referred to and finally resolved by arbitration in the following manner:
(i) The dispute shall be settled by arbitration in Hong Kong by the HKIAC in accordance with the HKIAC Rules in force when the Arbitration Notice is submitted in accordance with the HKIAC Rules. There shall be three (3) arbitrators.
(ii) The arbitral proceedings shall be conducted in English. To the extent that the HKIAC Rules are in conflict with the provisions of this Article 7.2, including the provisions concerning the appointment of the arbitrator, the provisions of this Article 7.2 shall prevail.
(iii) Each Party to the arbitration shall cooperate with each other Party to the arbitration in making full disclosure of and providing complete access to all information and documents requested by such other Party in connection with such arbitral proceedings, subject only to any confidentiality obligations binding on such Party.
(iv) The award of the arbitral tribunal shall be final and binding upon the Parties a party thereto, and the prevailing Party may apply to a court of competent jurisdiction for enforcement of such award.
(v) Any Party that is a party to the dispute shall be entitled to seek preliminary injunctive relief, if possible, from any court of competent jurisdiction pending the constitution of the arbitral tribunal.
7.3 Consent to Jurisdiction. Subject to Articles 7.1 and 7.2, each Party to this Agreement, by its execution hereof, (a) hereby irrevocably submits to the exclusive jurisdiction of the Courts for the purpose of any and all actions, suits or proceedings arising in whole or in part out of, related to, based upon or in connection with this Agreement or the subject matter hereof, (b) hereby waives to the extent not prohibited by Applicable Law, and agrees not to assert, by way of motion, as a defense or otherwise, in any such action, any claim that it is not subject personally to the jurisdiction of the Courts, that its property is exempt or immune from attachment or execution, that any such action brought in one of the Courts should be dismissed on grounds of forum non conveniens, should be transferred to any court other than one of the Courts, or should be stayed by reason of the pendency of some other proceeding in any other court other than one of the Courts, or that this Agreement or the subject matter hereof may not be enforced in or by such Court, and (c) hereby agrees not to commence any such action other than before one of the Courts nor to make any motion or take any other action seeking or intending to cause the transfer or removal of any such action to any court other than one of the Courts whether on the grounds of inconvenient forum or otherwise. Each Party further agrees that service or any process, summons, notice or document by U.S. registered mail to such Partys notice address provided for in this Agreement shall be effective service of process for any action, suit or proceeding in New York with respect to any matters to which it has submitted to jurisdiction in this Article 7.3.
8. MISCELLANEOUS .
8.1 Force Majeure .
Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any Governmental Authority. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all Commercially Reasonable Efforts necessary to cure such force majeure circumstances.
8.2 Assignment or Change of Control .
(a) Except as otherwise set forth in this Agreement, this Agreement and its rights, privileges, and obligations may not be assigned or otherwise transferred by either Party without the prior written consent of the other Party; provided that either Party may assign, without consent but with prior written notice, such Partys rights and obligations under this Agreement (i) in connection with a merger, consolidation, or sale of substantially all of the assigning Partys assets to an unrelated Third Party, (ii) in connection with a Change of Control;
or (iii) to an Affiliate of such Party; provided that, in the event of an assignment described in clause (i) or (ii), the non-assigning Party may at its sole discretion terminate this Agreement if such Change of Control reasonably presents a conflict of interest to continue with the successor entity. For the purposes of this Agreement, a Change of Control of a Party occurs upon (i) the closing of a sale of all or substantially all of the assets of such Party to a Third Party in one transaction or series of transactions, (ii) the closing of a merger or other business combination or transaction that results in a Third Party owning, directly or indirectly, of more than 50% of the voting securities of such Party, or (iii) the closing of a transaction, following which a Third Party acquires direct or indirect ability or power to direct or cause the direction of the management and policies of such Party or otherwise direct the affairs of such Party, whether through ownership of equity, voting securities, beneficial interest, by contract, or otherwise, provided that for the purposes of this Agreement, a Change in Control shall not be deemed to have taken place if such Change of Control transaction involves a reorganization or similar transaction amongst the direct or indirect shareholders or Affiliates of such Party, following which a shareholder or Affiliate of such Party emerges as the direct or indirect owner of more than 50% of the voting securities, or owning all or substantially all the assets of the Party, or acquiring the direct or indirect ability or power to direct or cause the direction of the management and policies of such Party. Any assignee must assume in writing the obligations of the assigning Party to which it is the assignee or successor. This Agreement shall be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns.
(b) A Party terminating pursuant to Article 8.2(a) must deliver three (3) months prior written notice within nine (9) months of the delivery of notice by the assigning Party of the effectiveness of such assignment.
(c) Notwithstanding anything to the contrary in this Agreement, no rights or obligations of a Party under this Agreement may be assigned or transferred to any Third Party or Affiliate pursuant to Article 8.2(a) unless all rights and obligations of such Party under the Collaboration Agreement are assigned or transferred to the same Third Party or Affiliate previous to or simultaneously with such assignment or transfer hereunder.
8.3 Severability .
If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement.
8.4 Notices .
All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized
overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:
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Fax: +852 2128 1778
With a copy to:
Hutchison Whampoa Limited
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or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a Business Day; (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (c) on the fifth Business Day following the date of mailing if sent by mail.
8.5 Applicable Law and Litigation.
All questions of inventorship will be determined in accordance with U.S. patent laws. In respect to all other Patent issues, the rights of the Parties will be governed by the laws
of the jurisdiction in which the applicable Patent is filed or granted. In all other respects, this Agreement shall be governed by and construed in accordance with the laws of New York without reference to any rules of conflict of laws.
8.6 Entire Agreement; Amendments.
The Agreement contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, with regard to the subject matter hereof (including the licenses granted hereunder) are superseded by the terms of this Agreement. The Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representatives of both Parties hereto.
8.7 Headings.
The captions to the several Articles hereof are not a part of the Agreement, but are merely for convenience to assist in locating and reading the Articles and Articles of this Agreement.
8.8 Independent Contractors .
It is expressly agreed that Hutchison and Lilly shall be independent contractors and that the relationship between the two Parties shall not constitute a partnership, joint venture or agency. Neither Hutchison nor Lilly 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.
8.9 Waiver .
The waiver by either Party of any right hereunder, or the failure of the other Party to perform, or a breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach or failure by such other Party whether of a similar nature or otherwise.
8.10 Waiver of Rule of Construction .
Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement. Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.
8.11 Construction .
Except where the context expressly requires otherwise, (a) the use of any gender herein shall be deemed to encompass references to either or both genders, and the use of the singular shall be deemed to include the plural (and vice versa), (b) the words include, includes and including shall be deemed to be followed by the phrase without limitation, (c) the word will shall be construed to have the same meaning and effect as the word shall,
(d) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (e) any reference herein to any person shall be construed to include the persons successors and assigns, (f) the words herein, hereof and hereunder, and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (g) all references herein to Articles or Exhibits shall be construed to refer to Articles or Exhibits of this Agreement, and references to this Agreement include all Exhibits hereto, (h) the word notice means notice in writing (whether or not specifically stated) and shall include notices, consents, approvals and other written communications contemplated under this Agreement, (i) provisions that require that a Party, the Parties or any committee hereunder agree, consent or approve or the like shall require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), (j) references to any specific law, rule or regulation, or article, section or other division thereof, shall be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof, and (k) the term or shall be interpreted in the inclusive sense commonly associated with the term and/or.
8.12 Counterparts .
The 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. Each Party shall be entitled to rely on the delivery of executed facsimile copies of counterpart execution pages of this Agreement and such facsimile copies shall be legally effective to create a valid and binding agreement among the parties.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date.
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HUTCHISON CHINA MEDITECH LIMITED |
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/s/ Christian L. Hogg |
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Christian L. Hogg |
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CEO and Director |
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ELI LILLY AND COMPANY |
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/s/ Derica W. Rice |
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Derica W. Rice |
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THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
JOINT VENTURE AGREEMENT
by and between
HUTCHISON MEDIPHARMA (HONG KONG) LIMITED
and
NESTLÉ HEALTH SCIENCE S.A.
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NUTRITION SCIENCE PARTNERS LIMITED
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HUTCHISON CHINA MEDITECH LIMITED
27th NOVEMBER, 2012
TABLE OF CONTENTS
Article I. DEFINITIONS |
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Article II. ORGANIZATION AND CAPITALIZATION OF THE COMPANY |
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Article III. GENERAL RESPONSIBILITIES OF THE COMPANY AND PARTIES |
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Article IV. UNDERTAKINGS AND AGREEMENTS OF THE PARTIES |
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Article V. WARRANTIES AND COVENANTS |
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Article VI. ADDITIONAL FUNDING; ACQUISITION AND OWNERSHIP OF SHARES |
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Article VII. BOARD OF DIRECTORS OF THE COMPANY |
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Article VIII. GENERAL MEETING OF SHAREHOLDERS |
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Article IX. OFFICERS; MANAGEMENT OF THE COMPANY |
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Article X. INFORMATION RIGHTS |
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Article XI. INTELLECTUAL PROPERTY |
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Article XII. CONFIDENTIALITY OF INFORMATION |
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Article XIII. GUARANTEE AND INDEMNITIES |
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Article XIV. TERM AND TERMINATION |
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Article XV. MISCELLANEOUS |
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EXHIBIT & SCHEDULES
JOINT VENTURE AGREEMENT
THIS JOINT VENTURE AGREEMENT ( Agreement ) is entered into as of the 27 th day of November, 2012 (the Execution Date ) by and between:
(1) Hutchison MediPharma (Hong Kong) Limited, a limited company organized and existing under the laws of Hong Kong with its principal offices at 22nd Floor, Hutchison House, 10 Harcourt Road, Hong Kong ( Hutchison );
(2) Nestlé Health Science S.A., a company organized and existing under the laws of Switzerland with its principal offices at Rue des Remparts 2, 1095 Lutry, Switzerland ( Nestlé );
(3) Nutrition Science Partners Limited, a company organized and existing under the laws of Hong Kong with its principal offices at 22nd Floor, Hutchison House, 10 Harcourt Road, Hong Kong (the Company ); and
(4) Hutchison China MediTech Limited, a company organized and existing under the laws of the Cayman Islands with its principal offices at PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman Islands (the Guarantor ).
Hutchison, Nestlé and the Company are hereinafter referred to collectively as the Parties and individually as a Party.
WITNESSETH:
WHEREAS, Hutchison and Nestlé have agreed to enter into a joint venture (the Joint Venture ), subject to Antitrust Approvals, for the purpose of developing science-based personalized nutritional solutions from botanical sources for the global market. Hutchison MediPharma Limited, a limited company organized and existing under the laws of the Peoples Republic of China and an Affiliate of Hutchison, has accumulated both expertise and capabilities in research and development activities in relation to identifying and developing novel naturally-derived medical foods, food supplements and drug products, in the conduct of the Hutchison Business, through the Hutchison Library and Hutchison Botanical R&D Platform (each as defined below). Under and subject to the terms of the Research and Development Collaboration Agreement (as defined below), the Company will hold exclusive rights over the Hutchison Library and the Hutchison Botanical R&D Platform in the Research Field. The Company will use these exclusive rights to pursue (i) the discovery, development, registration, manufacture and commercialization of Products in the Field and (ii) the performance of research and development with the aim of developing novel naturally-derived medical foods, food supplements or drug products from the Hutchison Library in the Research Field;
WHEREAS, in order to carry out the Joint Venture, Hutchison has formed the Company, a private company limited by shares under the Hong Kong Companies Ordinance (Cap. 32) and whose shares, as of Completion and subject to Antitrust Approvals, will be owned in equal number by each of Nestlé and Hutchison; and
WHEREAS, Hutchison and Nestlé desire to enter into this Agreement to memorialize their mutual agreements and understandings on the establishment, financing and operation and management of the Company, and their respective rights and obligations relative thereto.
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE I.
DEFINITIONS
The terms defined in this Article will have the meanings ascribed to them herein whenever they are used in the Agreement, unless otherwise clearly indicated by the context.
1.1 Acquired Know-How means any Information that is necessary or useful for the manufacture, use or sale of HMPL-004 or any Products containing HMPL-004 (other than any such Information that is related to any other active ingredient in a Product (other than HMPL-004) that is not related to HMPL-004).
1.2 Acquired Patent Rights shall mean the Patent Rights set forth on Schedule 1.2 .
1.3 Acquired Technology means the Acquired Know-How and Acquired Patent Rights.
1.4 Affiliate(s) means, with respect to a Person, any Person that controls, is controlled by, or is under common control with such first Person. For purposes of this definition only, control means (i) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities, or by contract relating to voting rights or corporate governance, or otherwise, or (ii) to own, directly or indirectly, more than fifty percent (50%) of the outstanding voting rights exercisable at a shareholder meeting (or equivalent), or other ownership interests, of such Person. Notwithstanding the foregoing, neither Nestlé nor Hutchison nor the Guarantor nor their respective Affiliates will be considered Affiliates of the Company.
1.5 Agreement will have the meaning set forth in the introduction.
1.6 Ancillary Agreements means the Services Agreements and the Research and Development Collaboration Agreement.
1.7 Antitrust Approvals means the approval of the establishment of the Joint Venture by the Parties pursuant to the terms of this Agreement by, if required under Applicable Laws, the competition authorities of relevant jurisdictions including the European Commission in respect of European Union merger control clearance and the Ministry of Commerce of the Peoples Republic of China in respect of the Peoples Republic of China anti-monopoly law and such other approvals as reasonably agreed between the Parties. When used as Antitrust Approval means approval required in a specific country or territory from a single competition authority.
1.8 Applicable Laws means all applicable laws, statutes, ordinances, regulations, rules, guidance, or orders of any kind whatsoever (including without limitation from any Regulatory Authority), including (without limitation) the FD&C Act, Prescription
Drug Marketing Act, Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a et seq.), and Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.), the Hong Kong Companies Ordinance (Cap. 32 of the Laws of Hong Kong) and all counterparts thereto in other jurisdictions, all as amended from time to time.
1.9 Articles of Incorporation means the memorandum of association and articles of association of the Company filed with the Hong Kong Companies Registry pursuant to which the Company is formed and registered, as amended from time to time.
1.10 Board will have the meaning set forth in Section 7.1.1 .
1.11 Board Approval Matters will mean the matters set out in Schedule 7.32 .
1.12 Budget will mean the projection of revenues and costs of the Company for the relevant Calendar Year as adopted by the Board from time to time.
1.13 Business Day will mean a day on which banks are open for normal banking business (excluding Saturday, Sunday and public holidays) in Hong Kong, the Peoples Republic of China and Switzerland (Canton de Vaud).
1.14 Buy/Sell Procedure will mean the final deadlock resolution procedure set forth in Schedule 7.6.5 .
1.15 Buyout will have the meaning set forth in Section 14.8 .
1.16 Buyout Date will have the meaning set forth in Section 14.8.1 .
1.17 Buyout Notice will have the meaning set forth in Section 14.8 .
1.18 Buyout Price will have the meaning set forth in Section 14.8.4 .
1.19 Buyout Shares will have the meaning set forth in Section 14.8 .
1.20 Calendar Quarter means each of the three (3) consecutive month periods ending on March 31, June 30, September 30, and December 31.
1.21 Calendar Year means each twelve (12) month period ending December 31.
1.22 Chairman means chairman of the Board.
1.23 Change of Control means, with respect to a Shareholder, the occurrence of any one of the following events: (i) a Third Party acquires, directly or indirectly, shares of such Shareholder representing fifty percent (50%) or more of the voting shares (where voting refers to being entitled to vote for the election of directors) then outstanding of such Shareholder, (ii) such Shareholder consolidates with or merges into another corporation or entity which is a Third Party, or any corporation or entity which is a Third Party consolidates with or merges into such Shareholder, in either event pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger are not held by the holders of the outstanding voting shares of such Shareholder preceding such consolidation or merger, or (iii) such Shareholder conveys, transfers or leases all or substantially all of its assets to a Third Party.
1.24 Clinical Trial means a human clinical study conducted on sufficient numbers of human subjects that is designed to (i) establish that a pharmaceutical product, food supplement or a medical food product is reasonably safe for continued testing, (ii) investigate the safety and efficacy of the pharmaceutical product, food supplement or the medical food product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product, food supplement or the medical food product in the dosage range to be prescribed or (iii) support Regulatory Approval (if required) of such pharmaceutical product, food supplement or medical food product or label expansion or demonstration of benefit of such pharmaceutical product, food supplement or medical food product, all in accordance with Applicable Laws.
1.25 Commercialization means any and all activities of using, importing, exporting, marketing, promoting, distributing, offering for sale or selling a Product including pre-commercial launch market development activities conducted in anticipation of Regulatory Approval of a Product, seeking pricing and reimbursement approvals for a Product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority regarding Post-Approval Clinical Trials, all activities required to fulfill ongoing regulatory obligations, including adverse event reporting and all activities relating to the licensing of a Product (including sourcing and negotiations with potential licensees). When used as a verb, Commercialize means to engage in Commercialization.
1.26 Company will have the meaning set forth in the introduction.
1.27 Completion means the completion of the establishment of the Joint Venture by the Parties in accordance with the provisions of Section 2.1 .
1.28 Completion Date means five (5) Business Days after the grant or waiver of the last Antitrust Approval, or such other day as agreed between the Shareholders.
1.29 Confidential Information means, with respect to a Party, all Information (and all tangible and intangible embodiments thereof), which is Controlled by such Party or any of its Affiliates and is disclosed by such Party or any of its Affiliates to another Party or any of their Affiliates pursuant to this Agreement.
1.30 Control or Controlled means, with respect to any Intellectual Property Right, Information, documents or materials, the possession, ownership, the ability to use pursuant to a license or sublicense and the ability to license or sublicense to another person, of such Intellectual Property Right, Information, document or materials, by a Party or any of its Affiliates (other than pursuant to this Agreement, the Ancillary Agreement and/or any License Agreement) as provided in this Agreement without violating an agreement with or other rights of any Third Party.
1.31 Deadlock Matters will have the meaning set forth in Section 7.6.2 .
1.32 Deadlock Notice will have the meaning set forth in Section 7.6.2 .
1.33 Deed of Adherence means the form of the deed of adherence set out in Schedule 1.33 to be executed by any Third Party Purchaser, pursuant to which the Third Party Purchaser will (i) be, and become, bound to this Agreement, and (ii) succeed to all of
the rights and obligations of the Transferring Shareholder hereunder to the proportional extent of such Ownership Percentage.
1.34 Default Interest Rate means twelve (12) month London Interbank Offered Rate plus [**] basis points.
1.35 Development means pre-clinical and clinical activities performed by or on behalf of the Company with respect to Products in an indication in the Field for the purpose of obtaining and maintaining Regulatory Approval with respect to such indication and activities performed by or on behalf of the Company with respect to Products destined as medical food products. Development will include, without limitation, all activities related to discovery, research, pre-clinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis, report writing performed pursuant to the Development Plan with respect to Products. Notwithstanding anything to the contrary in this Agreement, Development will not include Manufacturing or Commercialization. When used as a verb, Develop means to engage in Development.
1.36 Development Budget will have the meaning set forth in Section 3.2.5(i) .
1.37 Development Plan will have the meaning set forth in Section 3.2.5(i) .
1.38 Disclosing Party means the Party disclosing Confidential Information.
1.39 Dispute will have the meaning set forth in Section 15.1.2 .
1.40 Disputed Activity will have the meaning set forth in Section 3.2.5(iv)(A) .
1.41 Disputed Activity Costs will have the meaning set forth in Section 3.2.5(iv)(A)(2) .
1.42 Effective Date will have the meaning set forth in Section 2.1 .
1.43 Execution Date will have the meaning set forth in the introduction.
1.44 Fair Market Value means, on a per Share basis, (i) during the Lock-Up Period, an amount of [**] divided by the total number of Shares, and (ii) after the Lock-Up Period the fair market value of the Company as agreed upon by the Shareholders or, in the event the Shareholders do not agree within [**] days of initiation of the relevant valuation discussion, as determined by the provisions set forth in Schedule 1.44 , divided by the total number of Shares.
1.45 FD&C Act means the United States of America Federal Food, Drug, and Cosmetic Act, as amended, and the regulations promulgated thereunder.
1.46 FDA means the United States of America Food and Drug Administration or any successor agency thereto.
1.47 Field means, unless otherwise agreed between the Parties, (i) for Products that contain HMPL-004, the field in which a Product is Developed as determined by the Board on a Product-by-Product basis from time to time and (ii) for any Products that do not contain HMPL-004, the Research Field.
1.48 Finance Director means the person appointed as the finance director of the Company pursuant to Section 9.2 .
1.49 Funding Shareholder will have the meaning set forth in Section 3.2.5(iv)(A) .
1.50 General Manager means the person appointed as the general manager of the Company pursuant to Section 9.1 .
1.51 Government Authority means any court, agency, department, authority, regulatory body or other instrumentality of any national, state, county, city or other government or political subdivision.
1.52 HMPL-004 means the compound designated by Hutchison as HMPL-004, an oral botanical drug candidate which is an extract of Andrographis paniculata , as more fully described in Schedule 1.52 and as improved or modified from time to time.
1.53 HMPL-004 Warranties means the representations and warranties set out in Schedule 1.53 .
1.54 Hutchison will have the meaning set forth in the introduction.
1.55 Hutchison Botanical R&D Platform means the complete integrated botanical research and development capabilities of Hutchison and its Affiliates including, but not limited to, botanical chemistry, pharmacology, ADME/Toxicity (absorption, distribution, metabolism, excretion, and toxicity), CMC (chemistry, manufacturing, and control), and clinical and regulatory.
1.56 Hutchison Business means the research and development activities in relation to identifying and developing novel naturally-derived medical foods, food supplements or drug products in the Research Field from the Hutchison Library by utilizing the Hutchison Botanical R&D Platform.
1.57 Hutchison Compounds means (i) HMPL-004 or any other compound included in the Hutchison Library and (ii) any salt, free acid, free base, clathrate, solvate, hydrate, hemihydrate, anhydride, ester, chelate, conformer, congener, crystal form, polymorph, amorphous solid, homolog, isomer, stereoisomer, enantiomer, racemate, prodrug, isotopic or radiolabeled equivalent, metabolite, conjugate, complex or mixture of any of the foregoing compounds described in part (i) of this Section 1.57 .
1.58 Hutchison Library means (i) Hutchisons Affiliates collection of samples in its entirety derived from botanical sources and traditional Chinese medicine extracts, as such samples may be modified and expanded from time to time and (ii) the database containing the details of the compounds identified in such samples.
1.59 Hutchison Services Agreement will have the meaning set forth in Section 4.2 .
1.60 ICC means the International Chamber of Commerce.
1.61 IFRS means International Financial Reporting Standards.
1.62 IND means (i) an Investigational New Drug Application, as defined in the FD&C Act as amended, and the regulations promulgated thereunder, that is required to be
filed with the FDA before beginning clinical testing of a pharmaceutical product in human subjects; and (ii) any foreign counterpart of a US IND.
1.63 Information means any data, results, technology or information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical and clinical test data and data resulting from non-clinical studies), chemistry, manufacturing and controls information, stability data and other study data and procedures.
1.64 Initial Budget means the Budget set forth in Schedule 1.64 .
1.65 Initial Development Plan for HMPL-004 will have the meaning set forth in Section 3.2.5(ii) .
1.66 Intellectual Property means (i) any intellectual property or related proprietary rights in any jurisdiction, whether owned or held for use under license, whether registered or unregistered, including such rights in (a) all inventions, invention disclosures and improvements thereto (whether patentable or unpatentable and whether or not reduced to practice), all issued patents and pending patent applications, any divisions, continuations, continuations-in-part, reissues, continuing patent applications, reexaminations and extensions thereof and any counterparts claiming priority therefrom, and all utility models, design patents, patents of importation/confirmation, certificates of invention, certificates of registration and similar rights, (b) all trademarks, service marks, certification marks, trade dresses, logos, trade names and corporate names, including all goodwill associated therewith, and all applications, registrations and renewals in connection therewith, (c) all works of authorship (whether or not copyrightable), all copyrights, all moral rights and all applications, registrations and renewals in connection therewith, (d) all trade secrets and confidential business information and any rights to limit the use or disclosure thereof by any Person (including ideas, research and development, know-how, formulas, compositions, manufacturing and production processes and techniques, technical data, designs, drawings, specifications, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals), and (e) all internet domain names, (ii) all copies and tangible embodiments of any of the foregoing (in whatever form or medium) and (iii) any goodwill associated with the foregoing.
1.67 Intellectual Property Rights will mean any and all rights in relation to the Intellectual Property that exists of the Effective Date or thereafter coming into existence, and all applications for, renewals of and extensions of the foregoing, regardless of whether or not such rights have been registered with the appropriate authorities in such jurisdictions in accordance with the Applicable Laws.
1.68 IPR Subcommittee will have the meaning set forth in Section 3.2.4 .
1.69 License Agreement means (i) any of the HPML-004 license agreements to be entered into between the Company and Nestlé and/or any of its Affiliates under and
subject to the terms of the Option Agreement and (ii) any license agreement by which the Company licenses to any person any of its Intellectual Property Rights.
1.70 Lock-Up Period will have the meaning set forth in Section 6.3 .
1.71 Manufacture, Manufactured or Manufacturing means all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and storage of Products to be Developed or Commercialized, including active pharmaceutical ingredient manufacturing, whether such activities are conducted by the Company, its Affiliates or a Third Party contractor of such Party (under a contract manufacturing or tolling arrangement). Notwithstanding the foregoing, Manufacturing will not mean Developing or Commercializing. When used as a verb, Manufacture means to engage in Manufacturing.
1.72 Mediator will have the meaning set forth in Section 7.6.4(i).
1.73 Nestlé will have the meaning set forth in the introduction.
1.74 Nestlé Services Agreement will have the meaning set forth in Section 4.2 .
1.75 New Drug Application or NDA means a New Drug Application filed with the FDA as described in 21 CFR § 314, or any corresponding application for Regulatory Approval (not including pricing and reimbursement approval) in any country or regulatory jurisdiction other than the US.
1.76 Non-Terminating Shareholder will have the meaning set forth in Section 14.5 .
1.77 Non-Transferring Shareholder will have the meaning set forth in Section 6.4.1 .
1.78 Option Agreement will have the meaning set forth in Section 4.1 .
1.79 Ownership Percentage means, with respect to any Shareholder, the percentage of total outstanding Shares on a fully diluted basis in the Company held by such Shareholder and its Affiliates.
1.80 Party or Parties will have the meaning set forth in the introduction.
1.81 Patent Rights means any and all (i) national and international patent applications filed under Applicable Laws in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (ii) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, (iii) utility models, petty patents or similar rights or protections based on the patent or patent applications or on the priority applications on which the patent or patent applications are based and includes all divisional, continuations, continuations-in-part, renewals and reissues of such patents, patent applications, utility models, petty patents, and (iv) any other rights or protections similar to any of the foregoing.
1.82 Person means 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 or department or agency of a government.
1.83 Phase III Clinical Trial means a Clinical Trial defined in 21 C.F.R. 312.21(c), as may be amended from time to time, or any equivalent thereto in any jurisdiction.
1.84 Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for the purposes of conducting safety surveillance and ongoing technical support of the Product.
1.85 Post-Approval Clinical Trial means any Clinical Trial for use of a Product in an indication, other than a Phase IV Clinical Trial, to be conducted after Regulatory Approval has been achieved for such indication.
1.86 Product Development Subcommittee will have the meaning set forth in Section 3.2.2 .
1.87 Products means any pharmaceutical product, food supplement or medical food product in finished form that contains a Hutchison Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.
1.88 Receiving Party means the Party receiving any Confidential Information from the Disclosing Party.
1.89 Reconvened Meeting will have the meaning set forth in Section 7.6.1 .
1.90 Regulatory Approval means, with respect to a Product, the approval and authorization of a Product by a Regulatory Authority in a country where such Product will be Manufactured or Commercialized, including with respect to the Commercialization of such Product, pricing approval.
1.91 Regulatory Authority means any supranational, national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity in any country involved in the granting of Regulatory Approvals.
1.92 Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in a particular country, whether obtained before or after Regulatory Approval in the country. Regulatory Submissions include, without limitation, investigational new drug applications and NDAs, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular country.
1.93 Research and Development Collaboration Agreement will have the meaning set forth in Section 4.3 .
1.94 Research Collaboration Subcommittee will have the meaning set forth in Section 3.2.3 .
1.95 Research Field means, unless otherwise agreed between the Parties, the field in which research on a Hutchison Compound will be conducted as determined by the Board, including (without limitation) the treatment, prevention or diagnosis of gastrointestinal diseases, disorders or conditions in humans and, subject to the terms of
the Research and Development Collaboration Agreement, if agreed by the Parties, brain health and metabolic health.
1.96 Research Plan will mean the plan describing the research to be conducted pursuant to the terms of the Research and Development Collaboration Agreement, including the anticipated timeline for the conduct of such activities and the full-time equivalents to be employed in performing such activities, the initial version of which is scheduled to the Research and Development Collaboration Agreement, as such plan may be amended from time to time in accordance with the terms of the Research and Development Collaboration Agreement and this Agreement.
1.97 Rules will have the meaning set forth in Section 15.1.3 .
1.98 Services Agreement means either the Nestlé Services Agreement or Hutchison Services Agreement, and Services Agreements means both.
1.99 Share Equivalents means convertible bonds, loan capital, warrants, options or other similar instruments or securities which are convertible into or exchangeable for, or which carry a right to subscribe for Shares.
1.100 Shareholders means the Persons registered as members of the Company in the register of members of the Company, and who are parties to this Agreement, from time to time.
1.101 Shares means ordinary shares of the Company with a nominal value of [**] each; except where the context does not permit such construction, all references to the Shares of a Shareholder will be deemed to include Share Equivalents, if any, held by that Shareholder (calculated for this purpose as if all Share Equivalents had been fully converted into, exchanged for or exercised for subscription of Shares).
1.102 Subscription Price means [**].
1.103 Terminating Shareholder will have the meaning set forth in Section 14.5 .
1.104 Third Party means any Person other than Hutchison and its Affiliates, Nestlé and its Affiliates and the Company and its Affiliates.
1.105 Third Party Purchaser will have the meaning set forth in Section 6.4.1 .
1.106 Transfer will have the meaning set forth in Section 6.3 .
1.107 Transfer Notice will have the meaning set forth in Section 6.4.1 .
1.108 Transfer Shares will have the meaning set forth in Section 6.4.1 .
1.109 Transferring Shareholder will have the meaning set forth in Section 6.4.1 .
1.110 Unresolved Matter will have the meaning set forth in Section 7.6.1 .
1.111 US means the United States of America.
1.112 Joint Venture will have the meaning set forth in the recitals.
1.113 JV Activities will have the meaning set forth in Section 3.1 .
1.114 JV Term will have the meaning set forth in Section 14.1 .
ARTICLE II.
ORGANIZATION AND CAPITALIZATION OF THE COMPANY
2.1. Effective Date . The provisions of ARTICLE I , Sections 2.1 , 2.2 , 2.3 , 2.4 , 5.1 , and 5.2 , ARTICLE XII and ARTICLE XV are effective and legally binding in accordance with their terms upon Hutchison and Nestlé as from, and including, the Execution Date. The other provisions of this Agreement (including its Schedules and Exhibits) will be effective and binding upon Hutchison and Nestlé following the performance (or waiver by Hutchison and Nestlé) of the actions set out in Schedule 2.1 and the receipt and satisfaction of the Antitrust Approvals, provided that the representations and warranties set out in Sections 5.1 , 5.2 , 5.3 and 5.4 are true and accurate on such date (the Effective Date ). The provisions of this Agreement will be effective and legally binding in accordance with its terms on the Company and the Guarantor on, and subject to the occurrence of, the Effective Date.
2.2. Antitrust Approvals . Nestlé and Hutchison will use reasonable endeavors to prepare such documents as are necessary to ensure the satisfaction of the Antitrust Approvals as soon as reasonably practicable. In particular, (i) each of Nestlé and Hutchison will, unless otherwise agreed between the Parties, retain separate counsel to represent each Shareholder in making joint filings to the relevant competition authorities with respect to the Antitrust Approvals and (ii) the Parties shall furnish on a counsel-to-counsel basis only all information required for such filings and any additional information as may be required to respond to any requests for information by any competition authorities, provided that neither Party shall be required to provide the other Party with any confidential information or business secrets. To the extent legally permissible and subject to the protection of confidentiality in accordance with the previous sentence, each Party will (i) without undue delay provide the other Party with copies of any correspondence with the competition authorities and of copies of any written statement, order or decision of such authorities, (ii) consult and agree with the other Party regarding the initiation and contents of any communication with the competent authority prior to such communication being made, (iii) promptly provide each other with copies of any communication received or sent in connection with any proceeding and (iv) give each other and their respective advisors the opportunity to participate in all meetings, conferences and telephone calls with any competition authorities, provided, however, that materials may be edited to remove information if necessary in order to comply with Applicable Laws and confidentiality and business secrets concerns under the previous sentence. Neither Shareholder may withdraw filings with the competition authorities or agree with such authorities on the extension of any examination period without the express prior consent of the other Shareholder, which shall not be unreasonably withheld or delayed.
2.3. Antitrust Conditions or Undertakings . Nestlé and Hutchison agree that where an Antitrust Approval is granted subject to any condition or undertaking, such Antitrust Approval will not be deemed satisfied unless and until any such condition or
undertaking is reasonably acceptable to the party suffering the burden of such condition or undertaking. The Antitrust Approvals will only be satisfied once each Antitrust Approval that is required has been granted or such requirement has been waived by the Shareholders.
2.4. Antitrust Approvals not Satisfied . Nestlé and Hutchison agree that this Agreement will be terminated if the Antitrust Approvals, after the joint filings referred to in Section 2.2 have been made, are not satisfied in accordance with Section 2.3 .
2.5. Pre-Completion Operations . The Parties agree that Hutchison or its Affiliates may incur costs and expenditure with respect to the Development of HMPL-004 after the date of this Agreement. Upon, and subject to, the occurrence of the Effective Date, the Company will reimburse Hutchison and/or its Affiliates for such costs and expenditure incurred between the date of this Agreement and the Effective Date, upon receipt of reasonable written justification.
2.6. Incorporation of Company . Hutchison, prior to the Execution Date, has formed the Company as the vehicle for the Joint Venture between Hutchison and Nestlé and delivered to Nestlé a certificate of incorporation as conclusive evidence of the Companys due registration under Hong Kong law.
2.7. Corporate Name . The name of the Company will be Nutrition Science Partners Limited.
2.8. Principal Office . The principal office of the Company will be 22nd Floor, Hutchison House, 10 Harcourt Road, Hong Kong. The books and records of the Company will be kept and maintained at 22/F, Hutchison House, 10 Harcourt Road, Hong Kong.
2.9. Ownership Percentages . On the Effective Date, Hutchison and Nestlé will each have an Ownership Percentage equal to fifty percent (50%).
2.10. No Trading Prior to Effective Date . Hutchison warrants to Nestlé that, immediately prior to the actions set out in Schedule 2.1 , the Company has not issued any Shares other than Shares held by Hutchison which are fully-paid up and free of all encumbrances, has not traded nor has it received any income or made any gains nor has it entered into any contract (other than this Agreement, the Ancillary Agreements, the Option Agreement and transactions relating to the acquisition of Intellectual Property relating to HMPL-004) since its date of incorporation, has no assets (other than cash with accrued interest in respect of its fully paid up Share and the Acquired Technology) or liabilities (whether actual, contingent or otherwise) other than, in each case, its interest and obligations in this Agreement, the Ancillary Agreements and the Option Agreement and there is no agreement in force (other than this Agreement) which grants the right to any person to call for the allotment, issue or transfer of any Share. Hutchison (contracting for itself and as trustee for the Company) agrees to indemnify and keep indemnified Nestlé and the Company on demand against all losses, liabilities and costs which either Hutchison or the Company may incur arising out of, or in connection with, any breach of this Section 2.10 .
ARTICLE III.
GENERAL RESPONSIBILITIES OF THE COMPANY AND PARTIES
3.1. General Business Objectives and Activities . Unless otherwise agreed upon by the Shareholders in writing and subject to the terms of this Agreement, the business objectives and activities of the Company will be limited to (a) the Development, Manufacture and Commercialization of HMPL-004 in the Field and any and all activities related or incidental thereto and (b) research and development activities to identify, Develop, Manufacture and Commercialize novel naturally-derived medical foods, food supplements or drug products from the Hutchison Library in the relevant Research Field (such objectives and activities collectively, as amended from time to time pursuant to this Agreement, the JV Activities ). The Parties agree and acknowledge that, and the Shareholders will procure that the Company ensures that, all JV Activities will be conducted in accordance with this Agreement (including all agreements entered into in connection with this Agreement by the Company or by its Affiliates, subcontractors, licensees or sublicensees).
3.2. Development Responsibilities .
3.2.1. General . The Company will, and each Shareholder will, through its equity ownership in the Company, cause the Company to promote and develop the business of the Company and the JV Activities, including without limitation, making all filings with a view to obtain any relevant Regulatory Approval for bringing to the market any Product in its designated Field as soon as reasonably practicable, all in accordance with and pursuant to this Agreement, including, without limitation, any Development Plan in force from time to time.
3.2.2. Product Development Subcommittee . Immediately after the Effective Date, the Company will establish a Product Development Subcommittee of the Board (the Product Development Subcommittee ), which will, in addition to having those responsibilities and duties set forth in this Agreement and given to it by the Board, be responsible for making recommendations to the Board with respect to those decisions set forth in Schedule 3.2.2 . The Product Development Subcommittee will have an equal number of members representing each Shareholder and will meet once each Calendar Quarter unless otherwise instructed by the Board. Decisions by the Product Development Subcommittee will be made by unanimous agreement of all of the members on the Product Development Subcommittee and any decisions on which the Product Development Subcommittee cannot agree will be elevated to the Board.
3.2.3. Research Collaboration Subcommittee . Immediately after the Effective Date and as further detailed in the Research and Development Collaboration Agreement, the Research Collaboration Subcommittee will be established by the Company (the Research Collaboration Subcommittee ), Nestlé and Hutchison to oversee research and development activities to identify and develop novel naturally-derived medical foods, food supplements or pharmaceutical drug products from the Hutchison Library.
3.2.4. IPR Subcommittee . Immediately after the Effective Date, the Company will establish an Intellectual Property Rights Subcommittee of the Board (the IPR Subcommittee ), which will, in addition to having those responsibilities and duties given to it by the Board, be responsible for registering or otherwise protecting all Intellectual Property Rights of the Company capable of being protected, if desirable to do so, as decided by the IPR Subcommittee. The IPR Subcommittee will be further responsible for compiling and delivering all filings and applications (including renewals), or overseeing the same, and approving payments of any associated costs and will instruct Third Party service providers and law firms in this respect. The IPR Subcommittee may delegate all or some of its functions or responsibilities to any Person (including a Shareholder or their Affiliates). The IPR Subcommittee will have an equal number of members representing each Shareholder and will meet once each Calendar Quarter unless otherwise instructed by the Board. Decisions by the IPR Subcommittee will be made by unanimous agreement of all of the members on the IPR Subcommittee and any decisions on which the IPR Subcommittee cannot agree will be elevated to the Board.
3.2.5. Development Plan .
(i) General . Any Development of any Product in any designated field will be conducted pursuant to a comprehensive plan approved by the Board (the Development Plan ) that describes: (a) the overall program of Development for the Products, including non-clinical studies, toxicology, chemistry manufacturing and control development, Clinical Trials, regulatory plans and other elements of obtaining Regulatory Approval(s), and associated timelines and priorities, (b) timelines for key Regulatory Authority meetings, filing of applications for Regulatory Approval, and the receipt of Regulatory Approvals, (c) the anticipated tasks and responsibilities and resource allocation for the Company, Hutchison, Nestlé and their respective Affiliates pursuant to the Services Agreements and the Research and Development Collaboration Agreement, and (d) a budget for all Development activities (the Development Budget ).
(ii) Initial Development Plan for HMPL-004 . The initial Development Plan for HMPL-004 (including the initial Development Budget) attached hereto as Exhibit A (the Initial Development Plan for HMPL-004 ) is for the Development of HMPL-004 and related Products for two indications: ulcerative colitis and Crohns Disease. The Initial Development Plan for HMPL-004 will be effective from the Effective Date until an amended Development Plan is approved by the Board in accordance with this Agreement.
(iii) Amendments to the Development Plan .
(A) Once per Calendar Quarter, or more often as the Board deems appropriate, the Product Development Subcommittee will review the then-current Development Plan (including the Development Budget) and if deemed appropriate prepare amendments to the then-current Development Plan and the
corresponding Development Budget and submit such amendments for approval of the Board. Once approved by the Board, such amended Development Plan will cover the remaining current Calendar Year and the next Calendar Year (or such period that the Board will determine) and will contain a corresponding Development Budget, which will appropriately itemize the costs separately for each Product. Such updated and amended Development Plan will reflect any changes, re-prioritization of studies within, reallocation of resources with respect to, or additions to the then-current Development Plan. In addition, the Product Development Subcommittee may, of its own accord, prepare amendments to the Development Plan (including amendments to the Development Budget therein) for the Boards approval from time to time during a Calendar Year in order to reflect changes in such plan and budget for such Calendar Year and the next Calendar Year, in each case, in accordance with the foregoing. Once approved by the Board, the amended annual Development Plan (including amendments to the Development Budget therein) will become effective for the applicable period on the date approved by the Board (or such other date as the Board will specify). Any Board-approved amended Development Plan (including the Development Budget therein) will supersede the previous Development Plan for the applicable period.
(B) Subject to Section 3.2.5(iv) , in the event that the Product Development Subcommittee cannot reach agreement on an amended Development Plan to be submitted to the Board in accordance with this Section 3.2.5(iii) , it will inform the Board of its inability to make a decision and the Board will proceed with finalizing the Development Plan without the Product Development Subcommittees recommendation. If the Board is unable to agree on amendments to the Development Plan, the then-current Development Plan will remain in force until such time as an amended plan is adopted in accordance with the terms of this Agreement and, to the extent applicable, the provisions of Section 7.6 will apply.
(iv) Dispute regarding Clinical Activities .
(A) If the Board cannot reach a decision as to whether or not to continue or commence a clinical activity (as opposed to decisions regarding the manner in which a Clinical Trial is to be continued or commenced) for a Product for an indication in a Field in a country or countries (such activity, the Disputed Activity ), the Shareholder wishing to undertake a Disputed Activity has the right to require the Company and its subsidiaries to do so if and for so long as such Shareholder (the Funding Shareholder ):
(1) provides written notice to the Company and the other Shareholder confirming that they require the Company to undertake the Disputed Activity; and
(2) pays all reasonable incremental costs (including without limitation out-of-pocket costs and additional staff cost required to undertake the Disputed Activity) within [**] days of an invoice provided by the Company and its subsidiaries for such payment (such costs, the Disputed Activity Costs ), subject to the Company and the relevant Shareholder agreeing (such agreement not to be unreasonably withheld) a detailed budget for such Disputed Activity Costs. Each Shareholder agrees to act in good faith with respect to such discussions. The Company will update the Shareholders on a monthly basis of the actual costs incurred versus the agreed budget and in any event will notify the Shareholders in the event the actual costs for the clinical activity relating to a Disputed Activity are likely to vary materially from the agreed Budget.
(B) In the event that Regulatory Approval is received for a Product for an indication in a field which is and continues to be the subject of a Disputed Activity when Regulatory Approval is received, the Company will, and the Shareholders will cause the Company to, reimburse the Funding Shareholder of all Disputed Activity Costs for such Disputed Activity and the non-Funding Shareholder will pay a further amount equal to [**] of the Disputed Activity Costs for such Disputed Activity to the Funding Shareholder as compensation for the risk incurred by the Funding Shareholder (both payments from the Company and from the non-Funding Shareholder to be made within [**] days of such Regulatory Approval). Upon receipt of such payment in full by the Funding Shareholder the clinical activity will cease to be a Disputed Activity. In the event Regulatory Approval is not received for the Product for an indication in the Field which is the subject of a Disputed Activity, the Company will not have any obligation to pay any Disputed Activity Costs for such Disputed Activity.
(C) At any time after a Disputed Activity commences for a Product in an indication in a Field until [**] months prior to the estimated date of Regulatory Approval for such Product in such indication (as reasonably estimated and notified in writing to the Shareholders by the Company), the Company may decide to Develop such Product in such indication under the Development Plan by reimbursing all Disputed Activity Costs for such Disputed Activity to the Funding Shareholder; provided that the non-Funding Shareholder may, during such
period, in its own sole discretion and on behalf of the Company, elect for the Company to take over the Disputed Activity and to continue to Develop such Product in such indication pursuant to this Section 3.2.5(iv)(C) . Upon receipt of the payment of such Disputed Activity Costs in full by the Funding Shareholder, the clinical activity will cease to be a Disputed Activity.
(D) For clarity, with respect to any Disputed Activity, the Funding Shareholder will have all decision-making authority regarding the conduct of the Disputed Activity, and the Company and its subsidiaries will conduct such Disputed Activity along with the Development activities of the Company under the Development Plan. The Company will ensure that it has sufficient resources to conduct both the Disputed Activity and the Development activities under the Development Plan in accordance with the timelines set out in the Development Plan. If necessary, and subject to the provisioning of costs set out in this Section 3.2.5(iv)(D) , the Company will obtain additional resources to conduct the Disputed Activity at the Funding Shareholders expense as part of the Disputed Activity Costs. The Funding Shareholder will indemnify, defend and hold harmless the other Shareholder and the Company (and, to the extent not affiliated with the Funding Shareholder, each of its and their respective employees, officers, directors, agents and sublicensees) for any losses, claims, liabilities, settlements, penalties, fines damages and expenses (including reasonable attorneys fees and expenses) that the other Shareholder or the Company may be required to pay to one or more Third Parties arising from or relating to a Disputed Activity initiated by such Funding Shareholder; provided that such Funding Shareholder will not incur any indemnification obligation to the extent that such claims, damages or expenses relate to or arise from (1) negligence or willful misconduct on the part of the Company, its subsidiaries or the other Shareholder (or their respective employees, officers, directors, agents and subsidiaries) or (2) conduct of an activity which is no longer a Disputed Activity.
The provision of Section 7.6 will not apply to any matters referred to in Section 3.2.5(iv) above on which the Board cannot reach agreement.
(v) New Projects or Products . Each Party agrees and acknowledges that there will be an open dialogue between the Shareholders and the Company regarding new potential products and/or projects to be added to the Research Plan. It is the intention of the Parties that the acquisition or license of Products and/or projects internally developed by the Company pursuant to the Research Plan will be discussed and negotiated on a case-by-case basis separate from the financial terms of
this Agreement and any other agreement between the relevant Parties. Neither Shareholder has the obligation to submit any new project or product to the Company or the other Shareholder for consideration and, except as set forth under this Agreement with respect to the Products, the Company will have no obligation to acquire, license or perform any activities with respect to any project or product submitted to it for consideration by a Shareholder.
(vi) Termination of Product Development . If the Product Development Subcommittee recommends, and the Board agrees, that the Development of a Product should be terminated, either entirely or with respect to an indication in a field or in a country or countries, subject to delivering a written notice to the Company within 30 days of the agreement of the Board to terminate the Development of the Product, either Shareholder will have the right to offer to purchase all rights to such Product or, as applicable, such terminated indication and in, as applicable, such terminated jurisdiction, on reasonable market terms to be negotiated in good faith by the Company and such Shareholder. If both Shareholders notify the Company that they wish to exercise the right to purchase all rights to the terminated Product, the Board will organize a two round open bid procedure and the Board will grant the relevant right to the Shareholder having made the best offer, taking into account the best interests of the Company. If neither Shareholder serves a written notice indicating its wish to purchase the rights to the terminated Product within thirty (30) days of the agreement of the Board to terminate the relevant Development, the Board may offer such rights to a Third Party.
3.3. Manufacturing Responsibilities . The Parties agree and acknowledge that the Company will be responsible for the Manufacturing and procurement of clinical supplies required to Manufacture any Products containing HMPL-004 or other Products to which the Company has the right to Manufacture pursuant to any other agreement between it and Hutchison or an Affiliate of Hutchison. The Company will be further responsible for securing commercial supplies of any such Products, subject to any license agreement that the Company may have entered into. In furtherance of the above, the Company will select any Third Party manufacturers or service providers on best possible commercial terms for the Manufacture. With respect to HMPL-004, Hutchison will assign, or procure the assignment, to the Company of all Third Party agreements in effect as of the Effective Date to which Hutchison and/or its Affiliates are a party, that relate to procurement of clinical supplies or Manufacturing of HMPL-004 or a Product containing HMPL-004 as required by the Company. The Company will, with the Boards oversight and input, direct the Manufacturing process of such clinical supplies. With respect to commercial supplies of Products containing HMPL-004 and Products to which the Company has the right to Manufacture hereunder or pursuant to any other agreement between it and Hutchison or an Affiliate of Hutchison, the Company will be responsible for securing such supply and Hutchison will assign, or procure the assignment of, all appropriate agreements to which Hutchison and/or its Affiliates is a party related to the
Manufacture of such Products, to the Company to the extent and on the timeframe notified to Hutchison by the Board. For any Manufacturing activities related to the clinical or commercial supply of relevant Products conducted in whole or in part by Hutchison and/or its Affiliates, Hutchison will assign, or procure the assignment of, such manufacturing agreements to the Company.
3.4. Commercialization of Products . The Parties agree and acknowledge that the Company will Commercialize, and develop a Commercialization strategy for all Products (including Products containing HMPL-004 or other Products that the Company has the right to Commercialize pursuant to any other agreement between it and Hutchison or an Affiliate of Hutchison) in their respective Fields, subject to the License Agreements and any other contractual undertakings of the Company from time to time. Such Commercialization strategy may result in the out-licensing of the Commercialization rights to the relevant Products in the Field to one or more Third Party providers if the Board deems such out-license to be in the Companys best interest. Subject to Section 15.2 , the Parties agree that prior to approaching any Third Party, the Company will discuss in good faith with Nestlé the terms upon which Nestlé may license the Commercialization rights to the relevant Products in the relevant Field but in no event will the Company be obliged to enter into such license.
ARTICLE IV.
UNDERTAKINGS AND AGREEMENTS OF THE PARTIES
4.1. Option Agreement . On the Effective Date, Nestlé will enter into an option agreement in the form attached hereto as Exhibit B (as amended from time to time by the Parties pursuant to its terms, the Option Agreement ). The Parties acknowledge that, in accordance with the terms of the Option Agreement, Nestlé has the right to convert, subject to certain conditions, an interim payment of [**] made to the Company into a loan to be repaid by the Company to Nestlé.
4.2. Services Agreement . On the Effective Date, Hutchison will, or will cause its Affiliates to, enter into a service agreement with the Company for the use of additional experienced employees of Hutchison and/or its Affiliates by the Company in connection with the Development and Manufacture of the Products, in the form attached hereto as Exhibit C (as amended from time to time by the Parties pursuant to its terms, the Hutchison Services Agreement ). On the Effective Date, Nestlé will, or will cause its Affiliates to, enter into a service agreement with the Company for the use of additional experienced employees of Nestlé and/or its Affiliates by the Company in connection with the Development and Manufacture of the Products, and in connection with the management of Intellectual Property Rights in accordance with Section 3.2.4 in the form attached hereto as Exhibit D (as amended from time to time by the Parties pursuant to its terms, the Nestlé Services Agreement ).
4.3. Research and Development Collaboration Agreement . On the Effective Date, Hutchison and Nestlé will, or will cause their respective Affiliates to, enter into a research and development collaboration agreement with the Company for the use of additional experienced employees of Hutchison, Nestlé and/or their Affiliates by the Company in connection with the research on compounds from the Hutchison Library, in the form attached hereto as Exhibit E (as amended from time to time by the Parties pursuant to its terms, the Research and Development Collaboration Agreement ).
4.4. Hutchison Library and Hutchison Botanical R&D Platform . In accordance with and subject to the terms of the Research and Development Collaboration Agreement, Hutchisons Affiliate will grant to the Company on the Effective Date exclusive rights over the Hutchison Library and Hutchison Botanical R&D Platform in the Research Field.
ARTICLE V.
WARRANTIES AND COVENANTS
5.1. Of Nestlé . Nestlé warrants to Hutchison that the following statements are true and correct as of the Execution Date and will be true and accurate as of the Effective Date:
5.1.1. It is a company duly organized and validly existing under the laws of its jurisdiction of incorporation. It has all requisite corporate or other applicable power and authority to enter into and perform its obligations under this Agreement.
5.1.2. Its execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on its part. This Agreement has been duly and validly executed and delivered by it and, assuming due and valid authorization, execution and delivery of this Agreement by the other Parties, constitutes legally binding obligations enforceable against it in accordance with the terms of this Agreement, except as the enforceability hereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors rights generally and equitable principles of general application.
5.1.3. Its execution, delivery and performance of this Agreement do not and will not violate, breach or conflict with (i) Nestlés organizational documents, (ii) any law, rule, regulation, judgment, order or decree applicable to it or (iii) any agreement or instrument by which it is bound or to which any of its assets or properties are subject.
5.1.4. No suit, action or other legal proceeding is pending or threatened against Nestlé or its Affiliates before any court, arbitration tribunal or other governmental authority, which seeks to disallow, challenge, enjoin, prohibit or impose any damages, penalties or restrictions on, or otherwise make illegal the consummation of, the transactions contemplated by this Agreement, and no investigation that could reasonably be expected to result in any such suit, action or proceeding is pending against Nestlé or its Affiliates.
5.1.5. All other government approvals and all authorizations, consents, approvals and waivers obtained by Nestlé in connection with the execution delivery and performance (as of the Execution Date) of this Agreement or the consummation of the transactions contemplated hereby have been duly obtained.
5.1.6. As of the Effective Date, there is no breach by Nestlé or its Affiliates of any provision (including without limitation, of any representations and warranties granted by Nestlé) of the Option Agreement and the Ancillary Agreements.
5.2. Of Hutchison . Hutchison warrants to Nestlé that the following statements are true and correct as of the Execution Date and will be true and accurate as of the Effective Date:
5.2.1. Hutchison is a company duly organized and validly existing under the laws of its jurisdiction of incorporation. It has all requisite corporate or other applicable power and authority to enter into and perform its obligations under this Agreement.
5.2.2. The Company is a company duly organized and validly existing under the laws of its jurisdiction of incorporation. It has all requisite corporate or other applicable power and authority to enter into and perform its obligations under this Agreement.
5.2.3. Hutchisons and the Companys execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on their part. This Agreement has been duly and validly executed and delivered by Hutchison and the Company and, assuming due and valid authorization, execution and delivery of this Agreement by the other Parties, constitutes legally binding obligations enforceable against them in accordance with the terms of this Agreement, except as the enforceability hereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors rights generally and equitable principles of general application.
5.2.4. Execution, delivery and performance of this Agreement do not and will not violate, breach or conflict with (i) Hutchisons or the Companys organizational documents, (ii) any law, rule, regulation, judgment, order or decree applicable to Hutchison or the Company or (iii) any agreement or instrument by which Hutchison or the Company is bound or to which any of their assets or properties are subject.
5.2.5. No suit, action or other legal proceeding is pending or threatened against Hutchison or its Affiliates or the Company before any court, arbitration tribunal or other governmental authority, which seeks to disallow, challenge, enjoin, prohibit or impose any damages, penalties or restrictions on, or otherwise make illegal the consummation of, the transactions contemplated by this Agreement and no investigation that could reasonably be expected to result in any such suit, action or proceeding is pending against Hutchison or its Affiliates or the Company.
5.2.6. All other government approvals and all authorizations, consents, approvals and waivers from any Person required to be obtained by Hutchison in connection with the execution, delivery and performance (as of the Execution Date) of this Agreement or the consummation of the transactions contemplated hereby have been duly obtained.
5.2.7. As of Effective Date, there is no breach by Hutchison or any of its Affiliates of any provision (including without limitation, of any representations and warranties granted by Hutchison or any of its Affiliates) of the Option Agreement and the Ancillary Agreements.
5.3. Of the Guarantor . The Guarantor warrants to Nestlé and the Company that the following statements are true and correct as of the Effective Date:
5.3.1. It is a company duly organized and validly existing under the laws of its jurisdiction of incorporation. It has all requisite corporate or other applicable power and authority to enter into and perform its obligations under this Agreement.
5.3.2. Its execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on its part. This Agreement has been duly and validly executed and delivered by it and, assuming due and valid authorization, execution and delivery of this Agreement by the other Parties, constitutes legally binding obligations enforceable against it in accordance with the terms of this Agreement, except as the enforceability hereof may be limited by bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors rights generally and equitable principles of general application.
5.3.3. Its execution, delivery and performance of this Agreement do not and will not violate, breach or conflict with (i) the Guarantors organizational documents, (ii) any law, rule, regulation, judgment, order or decree applicable to it or (iii) any agreement or instrument by which it is bound or to which any of its assets or properties are subject.
5.3.4. No suit, action or other legal proceeding is pending or threatened against the Guarantor or its Affiliates before any court, arbitration tribunal or other governmental authority, which seeks to disallow, challenge, enjoin, prohibit or impose any damages, penalties or restrictions on, or otherwise make illegal the consummation of, the transactions contemplated by this Agreement, and no investigation that could reasonably be expected to result in any such suit, action or proceeding is pending against the Guarantor or its Affiliates.
5.3.5. All other government approvals and all authorizations, consents, approvals and waivers obtained by the Guarantor in connection with its execution delivery and performance (as of the Execution Date) of this Agreement or its consummation of the transactions contemplated hereby have been duly obtained.
5.4. HMPL-004 Warranties . Hutchison represents and warrants to the Company and Nestlé that each of the HMPL-004 Warranties are true and accurate as of the Execution Date and will be true and accurate on the Effective Date.
ARTICLE VI.
ADDITIONAL FUNDING; ACQUISITION AND OWNERSHIP OF SHARES
6.1. Additional Funding .
6.1.1. Responsibility . The Shareholders will be responsible for providing additional funding required by the Company from the Shareholders as determined and in an amount and in the timeframe determined by the Board (whether in the form of capital contributions, shareholder loans or guarantees or otherwise); provided that each Shareholder will be responsible for only a percentage of the additional required funding equal to its respective Ownership Percentage at the time of such funding. All such additional funding (a) in the form of capital contributions will be made at Fair Market Value and (b) in the form of debt financing will be made on arms length terms.
6.1.2. Failure to Fund . In the event that a Shareholder fails to provide additional funding to the Company pursuant to Section 6.1.1 , the other Shareholder may elect to either (a) as its sole remedy in respect of such failure to fund only, terminate this Agreement pursuant to Section 14.2.1 or Section 14.3.1 , as applicable; (b) provide the additional funding to the Company it owes pursuant to Section 6.1.1 and, at its discretion, all or some (or none) of the additional funding owed by the non-funding Shareholder by way of subscription to Shares for a price equal to the Fair Market Value, thereby increasing its Ownership Percentage while decreasing the non-funding Shareholders Ownership Percentage; or (c) provide no additional funding (including any funding it owes pursuant to Section 6.1.1 ).
6.1.3. Short-Term Funding . Notwithstanding anything to the contrary in this Agreement, in the event that additional funding is required by the Company to fund the Budget approved by the Board, each Shareholder will make a short- term loan facility available to the Company in the amount equal to the total required funding multiplied by such Shareholders Ownership Percentage. The terms of such short-term facility will be acceptable to the Board and repayable by the Company over a [**] month period with interest. If a Shareholder fails to provide short term funding to the Company within [**] Business Days of such funding being due and payable pursuant to this Section 6.1.3 on more than [**] occasions in any [**] year period the other Shareholder may elect to terminate this Agreement as its sole remedy in respect of such failure to provide short-term funding only.
6.1.4. Payment Priority . If there is one or more short-term facilities granted under Section 6.1.3 outstanding at the time of the Companys liquidation or sale of all or substantially all of its assets, subject to the Company having sufficient funds following such payments to settle all outstanding creditors, the outstanding short-term facilities (including interest accrued thereunder) will be repaid in full prior to the payment of any of the Companys other outstanding obligations unless otherwise determined by the Board or under any agreement with a Third Party approved by the Board. Where sufficient funds would not be available to settle all outstanding creditors, the Shareholders will be repaid in accordance with Applicable Laws. The Shareholders agree and acknowledge that, as of the Execution Date, the Shareholders anticipate the need to make short-term facilities available to the Company pursuant to this Section 6.1.4 .
6.2. Preemptive Subscription Rights . Except as otherwise may be provided in this Agreement, each Shareholder will have the preemptive right (subject to the
Shareholders obligations to make capital contributions pursuant to Section 6.1 ) to subscribe for and purchase up to its pro rata portion (equal to such Shareholders then current Ownership Percentage) of any additional Shares or Share Equivalents newly issued by the Company at Fair Market Value to enable such Shareholder to maintain its Ownership Percentage.
6.3. Lock-Up Period . During the period beginning on the Effective Date and ending on the [**] anniversary of the Effective Date (the Lock-Up Period ), neither Shareholder nor any of their agents, nominees, or Affiliates will sell, transfer, pledge, mortgage or encumber, or agree to sell, transfer, pledge, mortgage or encumber, or otherwise dispose ( Transfer ) of any Shares without the prior written consent of the other Shareholder.
6.4. Right of First Refusal .
6.4.1. Following the Lock-Up Period and during the JV Term, in the event a Shareholder (the Transferring Shareholder ) intends to Transfer to a Third Party (the Third Party Purchaser ) all the Shares or interest in all the Shares owned by such Shareholder (the Transfer Shares ), such Shareholder will first offer the other Shareholder (the Non-Transferring Shareholder) the opportunity to purchase such Transfer Shares by giving written notice (the Transfer Notice ) to the Non-Transferring Shareholder of its intention to Transfer the Transfer Shares, setting forth the number of the Transfer Shares intended to be Transferred, the identity of the Third Party Purchaser (including the identity of the ultimate beneficial owner(s)), the proposed price per Share and other major terms and conditions of the proposed Transfer of the Transfer Shares.
6.4.2. The Non-Transferring Shareholder will then have the right to purchase all (but not some) of the Transfer Shares at the proposed price per Share and upon the major terms and conditions specified in the Transfer Notice by giving written notice to the Transferring Shareholder of its acceptance of such offer within [**] days after its receipt of the Transfer Notice from the Transferring Shareholder.
6.4.3. If the Non-Transferring Shareholder exercises its right under this Section 6.4 , the closing of the purchase of the Transfer Shares will take place within [**] days after the Non-Transferring Shareholder gives notice of such exercise or such other date as may be mutually agreed upon by the Shareholders, subject to any approvals required under Applicable Laws.
6.4.4. If the Non-Transferring Shareholder rejects the offer contained in the Transfer Notice or fails to respond to the Transferring Shareholder within [**] days after its receipt of the Transfer Notice from the Transferring Shareholder, the Transferring Shareholder will, subject to the Third Party Purchaser executing a Deed of Adherence, be free, during the period of [**] days following the earlier of its receipt of such rejection from the Non-Transferring Shareholder and the expiration of such [**] day period, to transfer all (but not some) of the Transfer Shares so offered to the Non-Transferring Shareholder to the Third Party Purchaser specified in the Transfer Notice at a per Share price equal to or higher than, and upon terms and conditions no more favorable than, set out in the Transfer Notice provided that such Third Party Purchaser will agree to be,
and become, bound to this Agreement and succeed to all of the rights and obligations of the Transferring Shareholder. In the event the Transferring Shareholder fails to Transfer such Transfer Shares to the Third Party Purchaser within the [**] day period, any subsequent Transfer will again be subject to the provisions of this Section 6.4 .
6.4.5. Any Transfer made or created in breach of this Section 6.4 will be null and void ab initio .
6.4.6. No Shareholder will have the right to sell some (but not all) of the Shares and Share Equivalents that it holds, other than with prior consent of the other Shareholder(s).
6.4.7. The provisions in Section 6.3 ( Lock-Up Period ) and Section 6.4 ( Right of First Refusal ) will apply to direct Transfers and to the Transfer of shares in any holding company holding directly or indirectly the Shares where the Shares form directly or indirectly a substantial part of the assets of such holding company.
6.4.8. The Transfer of any Shares or Share Equivalents will not have any impact on any Ancillary Agreement and/or any License Agreement except as otherwise provided in such agreements.
6.4.9. The Shareholders agree that, if a Third Party acquires any Shares or Share Equivalents of the Company pursuant to this Agreement, the Parties will negotiate in good faith appropriate amendments to this Agreement and the Ancillary Agreements to account for such additional holder of Shares or Share Equivalents and will, if appropriate, require any such Third Party to become a party to this Agreement, as so amended, as a condition to acquiring such Shares or Share Equivalents. Each Party will not unreasonably withhold or delay consent to commercially reasonable terms.
6.5. Exercise of Voting Rights . Each Party agrees to take all actions necessary to ensure that the Company will be managed, and the rights and obligations of the Shareholders will be implemented and enforced, in accordance with the terms of this Agreement, including voting all Shares held by it and (subject to fiduciary duties of the Directors under Applicable Laws) directing the Directors nominated by it to vote to give effect to the terms of this Agreement; provided , however , that the Shareholders will not be restricted from voting their respective Shares as they see fit so long as such exercise of voting rights does not conflict with the terms of this Agreement.
6.6. Additional Shares Acquired by the Shareholders . The provisions of this Agreement will apply to any other or additional Shares issued to, purchased or acquired by either Shareholder, whether such other or additional Shares are received, subscribed for, purchased or acquired by reason of any share dividend, share split or consolidation, capital increase, corporate merger or split, reorganization or other transactions or events.
6.7. Shares and Share Equivalents Held by Affiliates . Notwithstanding the other provisions of this ARTICLE VI , each Shareholder will have the right to Transfer any
Shares to any of its respective Affiliates provided that such Shareholder agrees to (i) procure the performance by such Affiliate of any obligation imposed on it under this Agreement (ii) repurchase such Shares in the event such Affiliate ceases to be an Affiliate and (ii) procure that such Affiliate enters into a Deed of Adherence in the form set out in Schedule 1.33 . Any Shares or Share Equivalents held by any Affiliate(s) of a Shareholder will be deemed owned and held by such Shareholder for all purposes of this Agreement (including for the purpose of determining such Shareholders Ownership Percentage), and such Shareholder will procure that all such Shares will be voted to give effect to and in accordance with the terms of this Agreement and that no such Shares or Share Equivalents will be Transferred except in accordance with the terms of this Agreement, in each case as if they were directly owned and held by such Shareholder.
6.8. Dividend Policy . The Shareholders will cause the Company to pay such dividends out of its distributable net earnings as are consistent with its operating and investment plans as approved by the Board. The payment and level of any dividend will be determined by the Board and approved by the Shareholders at a general meeting of Shareholders. In determining the amount of dividends to be distributed for each fiscal year, the Board will take into account the debt-to-equity ratio of the Company and the financial operating needs of the Company.
6.9. Fiscal Year . The Shareholders will cause the fiscal year of the Company to commence on January 1 and end on December 31 of each year; provided, however, that the first fiscal year will commence on the date of incorporation and end on December 31 of that year.
ARTICLE VII.
BOARD OF DIRECTORS OF THE COMPANY
7.1. Authority; Governance .
7.1.1. Board of Directors . The composition and role of the Board of Directors of the Company (the Board ) is set forth in this ARTICLE VII .
7.1.2. Key Officers .
(i) Hutchison will initially nominate the person to be appointed by the Board as the General Manager of the Company (the General Manager ). The General Manager will have the duties and limitations set forth in Section 9.1 . The right to nominate a General Manager will alternate between Hutchison and Nestlé every [**] years.
(ii) Nestlé will initially nominate the person to be appointed by the Board as the Finance Director of the Company (the Finance Director ). The Finance Director will have the duties and limitations set forth in Section 9.2 . The right to nominate a Finance Director will alternate between Hutchison and Nestlé every [**] years.
7.2. Composition of the Board .
7.2.1. Directors .
(i) The Board will consist of eight (8) Directors, with four (4) Directors nominated by each of Hutchison and Nestlé. In the event that the Ownership Percentage of a Shareholder decreases beneath fifty percent (50%), the number of Directors each Shareholder is entitled to nominate, as a percentage of the total number of Directors, will be as close as possible to the Ownership Percentage of each Shareholder, provided that any Shareholder with an Ownership Percentage of less than [**] will not be entitled to nominate any Director.
(ii) Each Shareholder entitled to nominate one or more Directors will consult in good faith with the other Shareholder prior to making such nomination, although the final decision to appoint such Director(s) will ultimately reside with such Shareholder.
7.2.2. Chairman . For so long as the Shareholders have an equal Ownership Percentage in the Company, the Shareholder entitled to nominate the chairman of the Board (the Chairman ) will rotate every [**] years with Nestlé initially having such right as of the Effective Date; provided that in the event that the Ownership Percentage of a Shareholder decreases beneath [**], the Shareholder with an Ownership Percentage above [**] will solely have the right to nominate the Chairman. The Chairman will conduct the following activities of the Board: (a) calling meetings of the Board, (b) preparing and issuing minutes of each such meeting within thirty (30) days thereafter, and (c) preparing and circulating an agenda for the upcoming meeting; provided , that the Chairman will include any agenda items proposed by either Director. The Chairman will not have any casting or second vote.
7.2.3. Replacement of Directors .
(i) Each Shareholder will have the right to replace any of its nominated Directors at any time for any reason, whether the term of his office has expired or not, without the consent of the other Shareholder; provided , however , that the Shareholder who so replaces its nominated Director will indemnify the Company for any claims, damages or expenses made or claimed by the replaced Director by reason of such replacement. If a Shareholder gives written notice of such replacement to the other Shareholder, the Shareholders will take and cause to be taken all necessary actions (including causing their respective nominated Directors to hold a meeting of the Board and adopt the necessary resolutions) to convene a general meeting of Shareholders as soon as practicable to elect a replacement Director nominated by the Shareholder who desires to replace its nominated Director.
(ii) If the number of Directors that a Shareholder is entitled to nominate is reduced hereunder, such Shareholder will determine which Director or Directors nominated by it are to be removed and cause such Director or
Directors to resign or to be removed forthwith, and will indemnify and hold the Company harmless against any claims, damages or expenses made or incurred by reason of such resignation or removal. Furthermore, such Shareholder will exercise its voting rights in favor of the election of the person(s) nominated by the other Shareholder as new Director or Directors, if such other Shareholder is entitled to fill the vacant office(s) of the resigning or removed Director or Directors hereunder.
7.2.4. Cooperation . Each Shareholder will exercise (and will cause each of its Affiliates to exercise) its voting rights so that the nominees of the other Shareholder will be elected as Directors in accordance with this Section 7.2 during the term of this Agreement. In addition, in connection with a general meeting of Shareholders at which the election of any Directors nominated by either Nestlé or Hutchison is proposed, Hutchison or Nestlé, as the case may be, will exercise (and will cause each of its Affiliates to exercise) any and all voting rights it may have through proxies or powers of attorney in favor of the election of such Directors.
7.3. Authority and Responsibility .
7.3.1. General . Except as otherwise set forth in this Agreement or mandated by Applicable Laws, ultimate responsibility for the management, direction and control of the Company will be vested in the Board; provided that, notwithstanding anything to the contrary in this Agreement, the matters listed in Schedule 8.1 hereto will require approval of the Shareholders at a general meeting of Shareholders of the Company, which approval must be made by the holders of not less than the number of Shares equal to [**] of the then outstanding Shares plus [**]. The Board may establish subcommittees as the Parties mutually deem appropriate and will establish the subcommittees referred to in this Agreement.
7.3.2. Responsibilities . Subject to the terms of this Agreement, the Board will be responsible for, in particular without limitation, the Board Approval Matters.
7.4. Meetings of the Board .
7.4.1. Meetings of the Board will be held at least twice per fiscal year at the principal office of the Company unless otherwise determined by the Board as to frequency and/or location. Meetings of the Board may also be convened at the request of any Director by written notice to the other Directors.
7.4.2. In convening a meeting of the Board, a written notice (in English) stating the agenda, date, time and place of the meeting will be sent to all of the Directors at least thirty (30) days prior to the date of such meeting. Such notice may be given by e-mail or facsimile. Each notice of a meeting of the Board will be accompanied by a copy of all reports and materials that are necessary or appropriate for prior review and consideration by the Directors of the matters on the agenda. The notice period set forth herein may be shortened or omitted with the written consent of all of the Directors. For this and other secretarial matters required by the Company, Hutchison will provide secretarial support
to the Company for so long as the Ownership Percentage of Hutchison and its Affiliates is [**] or more.
7.4.3. The Chairman will preside over each meeting of the Board. In the event the Chairman is unable or unwilling to perform such duty with respect to a meeting of the Board, the most senior of the Director (in age) will act as chairman of such meeting.
7.4.4. Each meeting of the Board will be conducted in English. The Company will provide such support as is reasonably necessary to ensure that all participants are able to fully understand and participate in the meeting. Directors may participate in and vote at a meeting of the Board via video conferencing equipment whereby all participants in the meeting can simultaneously see and hear each other or, to the extent permissible under Applicable Laws, via telephone conferencing equipment whereby all participants in the meeting can simultaneously hear each other.
7.4.5. A quorum for a meeting of the Board will be the presence of at least four (4) Directors then in office with at least two (2) Directors nominated by each Shareholder being present. Subject to Section 7.3.1 , all actions and resolutions taken at a meeting of the Board will be adopted by an affirmative vote of a majority of the Directors present at the meeting. Where a Director is unable to attend a meeting of the Board, such Director will undertake reasonable efforts to appoint an alternate Director to attend such meeting of the Board and such alternate Director shall count in the quorum and be entitled to vote on behalf of the Director for who they are an alternate for (in addition to their own vote where such alternate Director is also a Director).
7.5. Report to the Board . The Company will report the following information to the Board once each calendar month:
7.5.1. The unaudited financial statements of the Company (prepared in accordance with IFRS) consisting of a balance sheet as of the end of the preceding calendar month and the related statements of income (including earnings per share), shareholders equity and cash flows for the calendar month then ended, certified by the Finance Director of the Company; and
7.5.2. A written report comparing actual results for such calendar month to the annual budget and business plan and containing comments on any other significant operational or other developments which may have a material impact on the business of the Company.
7.6. Deadlock
7.6.1. Where (a) at a meeting of the Board or (b) at a meeting of the Shareholders, an agreement cannot be reached on a matter (the Unresolved Matter ), such meeting of the Board or the Shareholders, as applicable, will be adjourned for a period of [**] days before being reconvened (the Reconvened Meeting ) for reconsideration by the Board or the Shareholders, as applicable, of such Unresolved Matter.
7.6.2. In the event that, at a Reconvened Meeting, the Directors or the Shareholders (as applicable) are still unable to reach agreement on the Unresolved Matter, then a deadlock will be deemed to have occurred. When a deadlock is deemed to have occurred, Nestlé or Hutchison may within fifteen (15) Business Days of the Reconvened Meeting give written notice (the Deadlock Notice ) to the other that a deadlock has occurred and identify the matter over which the Parties are deadlocked (the Deadlock Matter ).
7.6.3. Within five (5) Business Days of service of a Deadlock Notice, the Deadlock Matter will be referred to the Chief Executive Officer of Nestlé S.A. (or its designee) and the Group Managing Director of Hutchison Whampoa Limited (or its designee). Each Shareholder will use all reasonable endeavors in good faith to resolve the Deadlock Matter.
7.6.4. [**]
(i) [**]
(ii) [**]
(iii) [**]
7.6.5. [**].
7.6.6. In the event of a Deadlock and for so long as the Deadlock Matter remains unresolved, the Shareholders will do all things reasonably in their power to ensure that the Company continues to operate in the ordinary course of its business (including without limitation all Clinical Trials) as such business existed at the time the Deadlock Matter arose and in accordance with the last budgets (including without limitation the Development Budget) and Development Plans then in force.
ARTICLE VIII.
GENERAL MEETING OF SHAREHOLDERS
8.1. Authority and Responsibility . The Shareholders will decide and resolve the matters listed in Schedule 8.1 hereto and other matters reserved by Applicable Laws at a general meeting of Shareholders.
8.2. General Meetings of Shareholders .
8.2.1. An annual general meeting of Shareholders will be held within three (3) months after the close of each fiscal year of the Company. An extraordinary general meeting of Shareholders may be held at any time pursuant to a resolution of the Board or by notice of either Shareholder to the other, with a copy of the notice being provided to the Board.
8.2.2. In convening a general meeting of Shareholders, a written notice (in English) stating the agenda, date, time and place of the meeting will be sent to all of the Shareholders at least fourteen (14) days prior to the date of such meeting. Each notice of a general meeting of Shareholders will be accompanied by a copy of all reports and materials that are necessary or appropriate for prior review and consideration by the Shareholders of the matters on the agenda. The notice period set forth herein may be shortened or omitted with the written consent of all of the Shareholders.
8.2.3. The Chairman will preside over each general meeting of Shareholders as chairman. In the event the Chairman is unable or unwilling to perform such duty with respect to a general meeting of Shareholders, a Director or an officer appointed by an affirmative vote of a majority of the Shares represented in person or by proxy at such meeting will preside over each general meeting of Shareholders as chairman of such meeting.
8.2.4. General meetings of Shareholders will be conducted in English. The Company will provide such support as is necessary to ensure that all participants are able to fully understand and participate in the meetings.
8.3. Quorum and Voting Requirements . Except to the extent otherwise required by mandatory provisions of Applicable Laws, any resolution or action at a general meeting of Shareholders will require an affirmative vote (whether in person or by proxy) of fifty percent (50%) of the total issued and outstanding Shares plus one (1) Share.
ARTICLE IX.
OFFICERS; MANAGEMENT OF THE COMPANY
9.1. General Manager . The Company will have a General Manager. Each Shareholder will exercise (and will cause each of its Affiliates to exercise) its voting rights so that the nominee of the Shareholder responsible for making such nomination pursuant to this Agreement will be elected as General Manager for the relevant period during the JV Term. The General Manager will be responsible for all day-to-day operating matters involving the Company and its subsidiaries, represent the Company, observe
and enforce the matters resolved by the Board and the general meeting of Shareholders and the provisions of this Agreement and be responsible for the general management of the Company. Notwithstanding anything to the contrary in this Agreement, the General Manager will not have the ability to make any decision which would result in a Party failing to act in accordance with this Agreement nor will the General Manager make any decision that is inconsistent with the then-current Budget or Development Plan. The party nominating the General Manager will be liable for paying the salary and compensation of the General Manager until such time as the Board agrees that the General Manager will either become a full-time employee of the Company, or be otherwise compensated by the Company.
9.2. Finance Director . The Company will have a Finance Director. Each Shareholder will exercise (and will cause each of its Affiliates to exercise) its voting rights so that the nominee of the Shareholder responsible for making such nomination pursuant to this Agreement will be elected as Finance Director for the relevant period during the JV Term. The Finance Director will be responsible for all day-to-day financial matters involving the Company and its subsidiaries, represent the Company, observe and enforce the financial matters resolved by the Board and the general meeting of Shareholders and the provisions of this Agreement and be responsible for the general financial management of the Company. Notwithstanding anything to the contrary in this Agreement, the Finance Director will not have the ability to make any decision which would result in the Company or a Shareholder failing to act in accordance with this Agreement nor will the Finance Director make any decision that is inconsistent with the then-current Budget or Development Plan. The party nominating the Finance Director will be liable for paying the salary and compensation of the Finance Director until such time as the Board agrees that the Finance Director will either become a full time employee of the Company, or be otherwise compensated by the Company.
9.3. Powers and Duties . Subject to the terms of this Agreement and the powers reserved to the Board and to the general meeting of Shareholders by Applicable Laws, the powers and duties of the General Manager and the Finance Director will be determined from time to time by the Board, and the powers and duties of all other officers of the Company will be determined from time to time by the General Manager. The General Manager and the Finance Director will report to the Board.
9.4. Compensation . The amount of remuneration, bonuses and severance allowances payable to the General Manager, the Finance Director and Directors will be determined by the Board. Severance allowances payable to the Directors will be determined in accordance with the officer severance pay regulations of the Company adopted by the Board. Notwithstanding the foregoing, a Director performing no executive or officer functions will receive no compensation from the Company.
9.5. Indemnification of Directors and Officers . To the maximum extent permitted by Applicable Laws, the Company will indemnify each Director, General Manager, Finance Director and other officers against all claims, judgments, liabilities (including liabilities to the Company), damages, expenses and costs (including attorneys fees and disbursements) for which he has been held liable or which he has incurred in connection with or arising out of the performance of his duties in his official capacity as Director, General Manager, Finance Director or other officer, unless such Director, General Manager, Finance Director or other officer acted in a manner that was
negligent, faulty in breach of his duties, or in breach of trust. With respect to all claims, judgments, liabilities (including liabilities to the Company), damages, expenses and costs (including attorneys fees and disbursements) for which a Director, General Manager, Finance Director or other officer has been held liable or which he has incurred in connection with or arising out of the performance of his duties in his official capacity as Director, General Manager, Finance Director or other officer but which are not indemnifiable by the Company pursuant to this Section 9.5 and are insurable at a commercially reasonable cost, the Company will obtain and maintain a directors and officers liability insurance policy with commercially reasonable coverage.
ARTICLE X.
INFORMATION RIGHTS
10.1. Financial Information . As long as a Shareholder has an Ownership Percentage of [**] or more, the Company will, and the Shareholders will procure the Company, to furnish such Shareholder with the information and materials set forth in Sections 10.1.1 through 10.1.3 below, together with an English version or translation thereof:
10.1.1. Within [**] days after the end of each Calendar Year, draft audited financial statements (including notes thereto) consisting of at least a balance sheet as of the end of such fiscal year and the related statements of income (including earnings per share) for the fiscal year then ended, prepared in accordance with IFRS and audited by a firm of independent public accountants of recognized standing which is mutually acceptable to the Parties;
10.1.2. Within [**] days after the end of each Calendar Year, (i) annual management reports and (ii) audited financial statements (including notes thereto) consisting of a balance sheet as of the end of such fiscal year and the related statements of income (including earnings per share), shareholders equity and cash flows for the fiscal year then ended, prepared in accordance with IFRS and audited by a firm of independent public accountants of recognized standing which is mutually acceptable to the Parties; and
10.1.3. Within [**] days after the end of each Calendar Quarter, unaudited financial statements (including footnotes thereto) consisting of a balance sheet as of the end of such fiscal quarter and the related statements of income (including earnings per share), shareholders equity and cash flows for the fiscal quarter then ended, certified by the chief financial officer of the Company.
10.2. Other Information . As long as a Shareholder has an Ownership Percentage of [**] or more, the Company will, and the Shareholders will procure the Company to, furnish such Shareholder with such information and/or materials as may be reasonably requested by such Shareholder to make an informed judgment pursuant to this Agreement or with respect to the agenda of a meeting of the Board or a general meeting of Shareholders, as soon as such information and/or materials are available and, as applicable, an English version or translation thereof.
10.3. Cooperation . As long as a Shareholder has an Ownership Percentage of [**] or more, the Company will, and the Shareholders will procure the Company to, make its financial management personnel available to such Shareholder as may be reasonably requested so that such Shareholder can consult with, and receive information from, such personnel as necessary to comply with any Applicable Laws. Furthermore, the Parties agree to, from time to time, amend this Section 10.3 at either Shareholders request to allow a Shareholder to receive information of a certain type (and/or at such a time) necessary for such Shareholder to comply with any Applicable Laws.
ARTICLE XI.
INTELLECTUAL PROPERTY
11.1. Ownership and License of Intellectual Property .
11.1.1. As between the Parties and subject to the terms of the Ancillary Agreements, each Party will own any Intellectual Property owned or otherwise Controlled by such Party as of the Effective Date provided that the Company will own the Acquired Technology as of the Execution Date.
11.1.2. Subject to the terms of the Ancillary Agreements and the License Agreements, (i) any and all inventions and other Intellectual Property that are conceived, discovered, developed or reduced to practice by the Company, or any Affiliate or Third Party (including the Shareholders) as part of its engagement by the Company to undertake work on behalf of or for the Company, as a result of or in connection with the Research, Development, Manufacturing, Commercialization, distribution or sale of the Hutchison Compounds and the Products will vest in and be owned by the Company, and (ii) the Company will bear all costs of registering, maintaining, protecting and enforcing Intellectual Property owned by the Company.
11.2. Ownership of Clinical Data and Trademarks . Subject to the terms of the Ancillary Agreements and the License Agreements, the Company will own all clinical data and trademarks related to the Hutchison Compounds and the Products conceived, discovered, developed or reduced to practice by the Company, or any Affiliate or Third Party (including the Shareholders) as part of its engagement by the Company to undertake work on behalf of or for the Company.
11.3. Ownership of Regulatory Filings and Approvals . Subject to the terms of the License Agreements, the Company will own and undertake all measures required to obtain and maintain Regulatory Approvals in any country or countries and the Board will determine who will own all regulatory filings and Regulatory Approvals for the Hutchison Compounds and Products in any other jurisdictions.
11.4. Conflict with Terms of an Ancillary Agreement . For the avoidance of doubt, in the event of any inconsistency between the terms of this ARTICLE XI and the terms of the Ancillary Agreements, a License Agreement or the Option Agreement, the terms of the relevant Ancillary Agreement, License Agreement or the Option Agreement will prevail.
ARTICLE XII.
CONFIDENTIALITY OF INFORMATION
12.1. Confidentiality . Each Party (the Receiving Party ) agrees to keep in strict confidence all Confidential Information that the other Party (the Disclosing Party ) provides, communicates or otherwise makes available to the Receiving Party and to protect the Confidential Information with the same degree of care normally used to protect its own Confidential Information of a similar nature. The Receiving Party will not disclose or allow disclosure of any Confidential Information to any Third Party and will not use any Confidential Information in any manner, except, in each case, for the purposes of implementing and enforcing this Agreement, the Option Agreement, each License Agreement or any Ancillary Agreement, without the prior written consent of the Disclosing Party.
12.2. Exceptions . The restrictions and obligations set forth in Section 12.1, 12.3 and 12.7 will not apply to any Confidential Information:
12.2.1. which is or becomes generally available to the public through no fault on the part of the Receiving Party;
12.2.2. which is lawfully in the possession of the Receiving Party (other than pursuant to the terms of this Agreement, the Option Agreement, each License Agreement, any Ancillary Agreement or any other related agreement), without restriction as to its disclosure, prior to the disclosure of such information by or on behalf of the Disclosing Party or the Company, as reasonably evidenced by appropriate documentation;
12.2.3. which lawfully becomes available to the Receiving Party from a source other than the Disclosing Party and the Company without any duty as to confidentiality or non-use;
12.2.4. which is independently developed or otherwise created by the Receiving Party (other than pursuant to the terms of this Agreement, the Option Agreement, each License Agreement, any Ancillary Agreement or any other related agreement) without the use of any Confidential Information of the Disclosing Party, as reasonably evidenced by appropriate documentation; or
12.2.5. which is required to be disclosed or provided to any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) (i) pursuant to Applicable Laws, judgment, decree or order; (ii) as necessary to make regulatory filings and communications related to the Hutchison Compounds or any Products; or (iii) for the purpose of asserting or defending against any claims relating to Intellectual Property Rights, including, in particular, any action taken to protect and enforce Intellectual Property Rights; provided , however , that (x) any such information disclosed pursuant to this Section 12.2.5 will be disclosed only to the extent required by Applicable Laws, judgment, decree or order; (y) except with respect to required disclosure to tax authorities, the Party seeking to disclose or provide such information will give the other Parties prompt written notice of such requirement and fully cooperate with the other Parties so that the other Parties and/or the Company (as the case may be) may obtain reasonable assurances
that confidential treatment will be accorded to such information; and (z) without limiting the generality of the foregoing, the Parties will use commercially reasonable efforts to ensure that, subject to Applicable Laws, the list of the Products is redacted from any copy of this Agreement, the Option Agreement, each License Agreement and any Ancillary Agreement required to be filed with any government or regulatory body.
12.3. Accuracy of Confidential Information . Each Party hereby acknowledges that the Confidential Information of the other Parties may still be under development, or may be incomplete, and that such information may relate to products that are under development or are planned for development. Except as specifically provided in ARTICLE Article XII , no Party makes any representations regarding the accuracy of its Confidential Information.
12.4. Remedies for Breach of Confidentiality Obligations . The Parties acknowledge that it will be impossible to measure the damages that would be suffered by the other Parties if a Party fails to comply with this ARTICLE XII and that in the event of any such failure, there may not be adequate remedy under Applicable Laws. Each Party will, therefore, be entitled in addition to any other rights and remedies to obtain specific performance by the other Parties of the obligations under this ARTICLE XII and to obtain immediate injunctive relief without having to post a bond. No Party will urge, as a defense to any proceeding for such specific performance or injunctive relief by another Party for breach of this ARTICLE XII , that the other Party has an adequate remedy under Applicable Laws.
12.5. Measures to Keep Confidentiality . Each Party agrees that, prior to giving access to any Confidential Information to any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, advisors, consultants and agents, it will require each such Person to agree to be bound by all obligations of confidentiality and non-use under this ARTICLE XII , and will take all reasonable steps and measures to ensure that each such Person will enter into a confidentiality undertaking to comply with and perform such obligations, in each case to the same extent as if they were direct parties to this Agreement.
12.6. Publicity . The Parties agree to coordinate all publicity with respect to their relationships and plans as shareholders of the Company. No Party will issue or make any press release or other public announcement or make any other public announcement with respect to the existence and terms of the Joint Venture, this Agreement, the Ancillary Agreements, the Option Agreement, the transactions contemplated hereby or thereby or the business, operations or activities of the Company and, except as required by any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) or by Applicable Laws, judgment, decree or order without the prior written consent of the other Parties, which consent will not be unreasonably withheld or conditioned.
12.7. Survival of Obligations . The obligations undertaken by the Parties under this ARTICLE XII (other than Section 12.6 ) will survive the termination of this Agreement for any reason and will remain in effect and be binding on the Parties for a period of ten (10) years after the termination of this Agreement; provided that to the extent any Confidential Information constitutes a trade secret, as defined in the U.S. Uniform Trade Secrets Act or any Applicable Laws, then the Receiving Party will
keep such trade secret confidential until such time as the Confidential Information no longer qualifies as a trade secret under Applicable Laws.
ARTICLE XIII.
GUARANTEE AND INDEMNITIES
13.1. Guarantee of Guarantor . In consideration for Nestlé entering into this Agreement, the Guarantor irrevocably and unconditionally guarantees to each of the Company and Nestlé the punctual performance of all obligations of Hutchison under Section 13.4 of this Agreement and undertakes to each of the Company and Nestlé that whenever Hutchison does not pay any amount when due under or in connection with Section 13.4 of this Agreement, the Guarantor shall immediately on demand pay that amount as if it was the principal obligor, so that the same benefits are conferred on each of the Company and Nestlé as they would have received if such obligation had been performed and satisfied by Hutchison.
13.2. The Guarantor, as principal obligor and as a separate and independent obligation and liability from its obligations and liabilities in Section 13.1 undertakes to indemnify and hold each of the Company and Nestlé harmless from and against any loss or costs suffered or incurred by it as a result of the non-performance by Hutchison of any of its obligations under this Agreement. This guarantee is a continuing guarantee and will extend to the ultimate balance of sums payable by Hutchison under this Agreement, regardless of any intermediate payment or discharge in whole or in part.
13.3. The obligations of the Guarantor will not be affected by any act, omission, matter or thing which, but for this ARTICLE XIII , would reduce, release or prejudice any of its obligations under this Agreement including (i) any time, waiver or consent granted to Hutchison or any other person, (ii) the taking, variation, compromise, exchange, renewal or release of, or refusal or neglect to perfect, take up or enforce, any rights against Hutchison under this Agreement, (iii) the insolvency (or similar proceedings) of Hutchison, any incapacity or lack of power, authority or legal personality of Hutchison or change in control, ownership or status of Hutchison, (iv) any amendment to this Agreement (subject to such amendment not increasing the extent of the Guarantors liability under this Guarantee without the Guarantors consent), (v) any illegality, invalidity or unenforceability of any obligation of any person under this Agreement, or (vi) any other act, event or omission which might operate to discharge, impair or otherwise affect any of the obligations of the Guarantor or any of the rights, powers and remedies conferred on the Company and Nestlé under this Agreement. The Guarantor waives any right which it may have to first require the Company or Nestlé to proceed against Hutchison before claiming from the Guarantor under this ARTICLE XIII .
13.4. Indemnification by Hutchison . Without restricting the rights of the Company or Nestlé to claim damages on any basis, in the event of any claim by the Company or Nestlé against Hutchison in respect of (i) any matter that results from the use of the Acquired Technology prior to the Effective Date by Hutchison, its Affiliates, its assignees, licensees or sublicenses (including all employees, agents and subcontractors thereof), (ii) any breach of any representation or warranty set out in Section 5.4 , or (iii) any misrepresentation in or omission from any schedule,
document, certificate or other instrument relating to the Acquired Technology, Hutchison covenants with the Company and Nestlé to pay on demand to each of the Company and Nestlé an amount equal to the aggregate of all liabilities, obligations, judgments, liens, injunctions, charges, orders, decrees, rulings, damages, dues, assessments, taxes, losses, fines, penalties, expenses, fees, costs, amounts paid in settlement (including reasonable attorneys and expert witness fees and disbursements in connection with investigating, defending or settling any action or threatened action) incurred by the Company or Nestlé (or their Affiliates), as applicable, arising out of any claim, damages, complaint, demand, cause of action, audit, investigation, hearing, action, suit or other proceeding asserted or initiated or otherwise existing in relation of such matters by a Third Party except, in each case, to the extent caused by the gross negligence or willful misconduct of the Company or Nestlé, or by breach of this Agreement by the Company or Nestlé.
ARTICLE XIV.
TERM AND TERMINATION
14.1. Term of Agreement . The term of this Agreement will begin upon the execution hereof by the Parties and will continue for an indefinite period thereafter until (i) the Company is dissolved and liquidated or (ii) this Agreement is sooner terminated by the mutual agreement of the Parties or pursuant to Section 2.4 or pursuant to the provisions of this ARTICLE Article XIV (the JV Term ).
14.2. Termination by Hutchison .
Hutchison may terminate this Agreement upon written notice to Nestlé if:
14.2.1. Nestlé does not provide additional funding to the Company pursuant to its obligations in Section 6.1.1 within five (5) days from the relevant payment date or in accordance with Section 6.1.3 ;
14.2.2. Nestlé is in a material breach of any of its warranties, covenants or obligations under this Agreement and fails to cure such breach within thirty (30) days after receipt of written notice from Hutchison specifying the particulars of such breach and requiring such breach to be remedied; or
14.2.3. Nestlé, any of its creditors or any other eligible party files or commences a proceeding for the liquidation, bankruptcy, receivership, reorganization, rehabilitation, composition or dissolution of Nestlé (and, in the case of any such proceeding brought against Nestlé, such proceeding has not been stayed or dismissed within ninety (90) days after the filing thereof), or Nestlé is unable to pay or has suspended payment of its debts generally as they become due (except debts being contested in good faith), or the creditors of Nestlé have taken over its management.
14.3. Termination by Nestlé . Nestlé may terminate this Agreement upon notice to Hutchison if:
14.3.1. Hutchison does not provide additional funding to the Company pursuant to its obligations in Section 6.1.1 within five (5) days from the relevant payment date or in accordance with Section 6.1.3 ;
14.3.2. Hutchison is in material breach of any of its warranties, covenants or obligations under this Agreement and fails to cure such breach within thirty (30) days after receipt of written notice from Nestlé specifying the particulars of such breach and requiring such breach to be remedied; or
14.3.3. Hutchison, any of its creditors or any other eligible party files or commences a proceeding for the liquidation, bankruptcy, receivership, reorganization, rehabilitation, composition or dissolution of Hutchison (and, in the case of any such proceeding brought against Hutchison, such proceeding has not been stayed or dismissed within ninety (90) days after the filing thereof), or Hutchison is unable to pay or has suspended payment of its debts generally as they become due (except debts being contested in good faith), or the creditors of Hutchison have taken over its management.
14.4. Termination Upon Change of Control . Upon a Change of Control of a Shareholder, such Shareholder will promptly notify the other Shareholder and, within sixty (60) days of becoming aware of such Change of Control, the other Shareholder may terminate this Agreement immediately upon written notice to the notifying Shareholder.
14.5. Effect of Termination .
If this Agreement is terminated by either Nestlé or Hutchison (the Terminating Shareholder ) pursuant to Section 14.2 , 14.3 or 14.4 , as the case may be, the Terminating Shareholder will have the option (which may be exercised by written notice to the other Shareholder (the Non-Terminating Shareholder) within sixty (60) days after the effective date of such termination) to have the respective Fair Market Value of (i) the Shares held by the Terminating Shareholder and its Affiliates and (ii) the Shares held by the Non-Terminating Shareholder and its Affiliates determined as soon as practicable. If the Terminating Shareholder elects to have such Fair Market Value determined, the Non-Terminating Shareholder will render such cooperation as may be necessary for determination of the Fair Market Value and will bear all costs and expenses associated with the determination of such Fair Market Value. Once such Fair Market Value has been determined and notified to the Terminating Shareholder and Non-Terminating Shareholder in writing, the Terminating Shareholder will have the option (which may be exercised by written notice to the Non-Terminating Shareholder within ninety (90) days after receipt by the Terminating Shareholder of written notice of such Fair Market Value) to either (x) purchase or have a Third Party purchase all (but not less than all) of the Shares of the Non-Terminating Shareholder and its Affiliates at the Fair Market Value so determined (or in the case of the termination of this Agreement pursuant to Section 14.2.1 , Section 14.2.2 , Section 14.3.1 or Section 14.3.2 (as applicable) at ninety percent (90%) of the Fair Market Value so determined) or (y) require the Non- Terminating Shareholder or its nominee to purchase all (but not less than all) of the Shares of the Terminating Shareholder and its Affiliates at the Fair Market Value so determined (or in the case of the termination of this Agreement pursuant to Section 14.2.1 , Section 14.2.2 , Section 14.3.1 or Section 14.3.2 (as applicable) at [**] of the Fair Market Value so determined). The Parties agree that the [**] discount and [**] premium referred to above is commercially
justifiable and constitutes a genuine pre-estimate of any losses suffered by the Terminating Shareholder.
14.6. Upon the termination of this Agreement, the Parties agree to undertake commercially reasonable efforts to terminate all Ancillary Agreements.
14.7. The Parties Agree that the exercise of any rights of termination pursuant to this ARTICLE XIV will be without prejudice to the Option Agreement and any License Agreement.
14.8. Procedures for Sale and Purchase of Shares . If the Terminating Shareholder gives notice (the Buyout Notice ) to the Non-Terminating Shareholder electing to purchase or have a Third Party purchase all of the Shares of the Non-Terminating Shareholder and its Affiliates or requiring the Non-Terminating Shareholder or its nominee to purchase all of the Shares of the Terminating Shareholder and its Affiliates in accordance with Section 14.5 , the following procedures will apply with respect to the sale and purchase (the Buyout ) of such Shares (the Buyout Shares ):
14.8.1. The Buyout will be completed at the principal offices of the Company on a date to be agreed by the Shareholders (the Buyout Date ), but in any event no later than sixty (60) days following receipt by the Non-Terminating Shareholder of the Buyout Notice.
14.8.2. If the Terminating Shareholder elects through the Buyout Notice to purchase all of the Shares of the Non-Terminating Shareholder and its Affiliates, the Non-Terminating Shareholder will notify the Terminating Shareholder of the number of Shares then held by it and its Affiliates no later than five (5) Business Days after receipt of the Buyout Notice.
14.8.3. No later than ten (10) Business Days prior to the Buyout Date, the Shareholder who will purchase the Buyout Shares pursuant to the Buyout Notice will notify the other Shareholder of the identity of the purchaser of the Buyout Shares. If such Shareholder nominates a Third Party to purchase the Buyout Shares, such Shareholder will remain jointly and severally liable for the performance by such Third Party of all obligations relating to the purchase of the Buyout Shares hereunder.
14.8.4. The price payable (the Buyout Price ) for the Buyout Shares will be determined in accordance with Section 14.5 .
14.8.5. The Buyout Price will be paid to the seller(s) of the Buyout Shares on or prior to the Buyout Date in US Dollars by means of a wire transfer of immediately available funds to a bank account or bank accounts designated by such seller(s) at least two (2) Business Days prior to the Buyout Date.
14.8.6. In exchange for payment of the Buyout Price, the seller(s) of the Buyout Shares will deliver the original share certificates representing the Buyout Shares to the purchaser at the closing of the Buyout, and the Company will thereafter cause the transfer of the Buyout Shares to be registered in its register of members and for new share certificates to be issued. The sale of the
Buyout Shares will be made without any representations or warranties on the part of the seller(s) other than that the seller(s) is the lawful owner of the Buyout Shares and has the full right and power to transfer the Buyout Shares to the purchaser, free and clear of any pledge, mortgage, charge, lien, security interest, option, third-party right, interest or claim or other encumbrances of a nature similar to any of the foregoing.
14.8.7. Each Shareholder will be responsible for obtaining all government approvals and other authorizations, consents, approvals and waivers from any Third Party required to be obtained by such Shareholder, its Affiliates or the purchaser of the Buyout Shares nominated by it in connection with the Buyout. The stamp duties, registration fees or similar taxes and fees payable in respect of the transfer of the Buyout Shares will be equally shared by the Parties.
14.9. Other Remedies . Except as otherwise set forth in this Agreement, nothing in this ARTICLE XIV will prevent a Party from enforcing any rights or remedies that may be available to it under the other provisions of this Agreement or under Applicable Laws, provided that the Terminating Shareholder will not have the right to claim any damages relating to a decrease in the value of their Shares if the Terminating Shareholder has elected to exercise the option to sell their Shares at a premium to the non-Terminating Shareholder or to buy the Non-Terminating Shareholders Shares at a discount pursuant to Section 14.5 . The termination of this Agreement for any reason will be without prejudice to (i) any such rights or remedies and (ii) any rights or obligations that have accrued or arisen prior to the effective date of such termination.
14.10. Survival of Provisions . The provisions of Sections 5.1 , 5.2 , 5.3 and 5.4 and ARTICLE X , ARTICLE XI , ARTICLE XII , ARTICLE XIII , ARTICLE XIV and ARTICLE XV will survive the termination of this Agreement for any reason.
ARTICLE XV.
MISCELLANEOUS
15.1. Governing Law, Jurisdiction; Dispute Resolution .
15.1.1. Governing Law . The interpretation and construction of this Agreement will be governed by the laws of England and Wales.
15.1.2. Dispute Resolution . In the event of a dispute arising out of or relating to this Agreement, (including regarding its existence, termination or validity) (a Dispute) any Party will provide written notice of the Dispute to the other Parties, in which event the Dispute will be referred to the executive officers of the Shareholders designated below or their successors. The designated officers will use reasonable efforts to attempt resolution by good faith negotiations within thirty (30) days after such notice is received. Said designated officers are initially as follows:
For Company: |
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The General Manager and the Finance Director |
For Hutchison: |
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The Chief Executive Officer |
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|
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For Nestlé: |
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The President and Chief Executive Officer |
|
|
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For Guarantor: |
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The Chief Executive Officer |
In the event the designated executive officers do not resolve such Dispute within the allotted thirty (30) days, any Party may, after the expiration of the thirty (30) day period, seek to resolve the Dispute through reference to arbitration in accordance with Section 15.1.3 . Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter (such as matters referred to in Section 7.6 ), which failure does not involve a breach by a Party of its obligations hereunder, will not be deemed a Dispute which may be referred for resolution by the Parties under this Section
15.1.3. Arbitration . All Disputes which are unresolved pursuant to Section 15.1.2 and which a Party wishes to have resolved will be referred upon the application of any Party to, and finally settled by, arbitration in accordance with the ICC Arbitration Rules (the Rules ) as in force at the date of this Agreement and as modified by this Section 15.1.3 , which Rules are deemed incorporated into this Section 15.1.3 . The number of arbitrators will be three (3), one of whom will be appointed by each Shareholder and the third of whom, who will act as chairman, will be nominated by the two party-nominated arbitrators, provided that if the third arbitrator has not been nominated within twenty (20) Business Days of the nomination of the second party-nominated arbitrator, such third arbitrator will be appointed by the ICC. The seat of arbitration will be London and the language of arbitration will be English.
The arbitrators will have the power to grant any legal or equitable remedy or relief available under law, including injunctive relief (whether interim and/or final) and specific performance, and any measures ordered by the arbitrators may be specifically enforced by any court of competent jurisdiction. Each Party retains the right to seek interim or provisional measures, including injunctive relief and including pre-arbitral attachments or injunctions, from any court of competent jurisdiction and any such request will not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate. For the avoidance of doubt, this Section 15.1.3 is not intended to limit the powers of the court exercisable in support of arbitration proceedings pursuant to Section 44 of the Arbitration Act 1996 or any Applicable Law.
15.2. Companys Enforcement Rights; Transactions with Affiliates . Any right of action (including, without limitation, enforcement) which the Company may have in respect of any breach of the Ancillary Agreements, the Option Agreement, any License Agreement or of any other agreement between the Company and any Shareholder and/or any of its Affiliates will be prosecuted by the Directors of the Company appointed by the Shareholder which is not, or whose Affiliate is not, responsible for the breach. Those Directors will have full authority on behalf of the Company to negotiate, litigate and settle any claim arising out of the breach or exercise any right of termination arising out of the breach and the Shareholders will take all steps within their power to give effect to the provisions of this Section 15.2 .
In addition, notwithstanding any other provision of this Agreement, any transaction (such as, without limitation, any License Agreement) entered into or to be entered into between the Company and a Shareholder or any of such Shareholders Affiliates, with respect to any such agreement will be unanimously approved by the Board. The Directors appointed by each Shareholder will have the right to participate in any negotiation and discussion on the merits and/or the terms of any such proposed transactions.
15.3. Waiver and Non-Exclusion of Remedies . A Partys failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy will 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
15.4. Notices .
15.4.1. Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 15.4.2 or to such other address as the Party to whom notice is to be given may have provided to the other Parties in accordance with this Section 15.4.1 . Such Notice will be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second (2) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 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.
15.4.2. Address for Notice .
Company:
Nutrition Science Partners Limited
22nd Floor, Hutchison House
10 Harcourt Road, Hong Kong
Attn: The General Manager
Fax: +852 2128 1778
With a copy to:
The Finance Director
c/o Nestlé Health Science S.A. Avenue Nestlé 55
1800 Vevey
Switzerland
Attn: President and Chief Executive Officer
Hutchison:
Hutchison MediPharma (Hong Kong) Limited
21/F Hutchison House
10 Harcourt Road
Central
Hong Kong
Attn: Chief Executive Officer
With a copy to:
Hutchison Whampoa Limited
22/F Hutchison House
10 Harcourt Road
Central
Hong Kong
Attn: Head Group General Counsel & Company Secretary
Fax: +852 2128 1778
Nestlé:
Nestlé Health Science S.A. Avenue Nestlé 55
1800 Vevey
Switzerland
Attn: President and Chief Executive Officer
With a copy to:
Nestlé Health Science S.A. Avenue Nestlé 55
1800 Vevey
Switzerland
Attn: General Counsel
Guarantor:
Hutchison China MediTech Limited
PO Box 309, Ugland House, Grand Cayman, KY1-1104, Cayman
Islands
Attn: Chief Executive Officer
Fax: +852 2128 1778
With a copy to:
Hutchison Whampoa Limited
22/F Hutchison House
10 Harcourt Road
Central
Hong Kong
Attn: Head Group General Counsel & Company Secretary
Fax: +852 2128 1778
15.5. Entire Agreement . This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter hereof. 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 or 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 will govern.
15.6. Conflict with Articles of Incorporation . The Parties acknowledge that the Articles of Incorporation of Company have not been amended as at the Effective Date and in the event of any inconsistency between the terms of this Agreement and the Articles of Incorporation of the Company, the terms of this Agreement will prevail.
15.7. Amendment . Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of Nestlé, Hutchison, the Guarantor and the Company.
15.8. Assignability . This Agreement and each and every covenant, term and condition hereof will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Neither this Agreement nor any rights or obligations hereunder may be assigned, delegated or transferred, directly or indirectly, by a Party to any Third Party without the prior written consent of the other Party other than, and to the extent, of a Transfer of Shares to an Affiliate in accordance with Section 6.7 . Any attempted assignment or delegation in violation of this Section 15.8 will be void.
15.9. No Benefit to Others . The provisions of this Agreement are for the sole benefit of the Parties and their Affiliates, successors and permitted assigns, and they will not be construed as conferring any rights in any other Persons except as otherwise expressly provided in this Agreement. A Person who is not a Party will have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the terms of this Agreement.
15.10. Counterparts . This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which taken together will be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission will be as effective as an original executed signature page.
15.11. Severability . To the fullest extent permitted by Applicable Laws, the Parties waive any provision of law that would render any provision in this Agreement invalid,
illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and will not form part of this Agreement. To the fullest extent permitted by Applicable Laws and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement will remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Laws and achieves, as nearly as possible, the original intention of the Parties.
15.12. Further Assurance . Each Party will perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
15.13. Publicity . Notwithstanding Section 12.6 , it is understood that the Parties will issue a press release announcing the execution of this Agreement in a form reasonably agreed between Nestlé and Hutchison. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of any subsequent press releases relating to the Agreement or the activity hereunder prior to the issuance thereof, provided that a Party may not unreasonably withhold consent to such releases, and that any Party may issue such press releases as it determines, based on advice of counsel, are reasonably necessary to comply with Applicable Laws or for appropriate market disclosure or which are consistent with information disclosed in prior releases properly made hereunder.
15.14. 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 in the event of any conflict in interpretation between the English version and such translation, the English version will prevail. English will be the official language of this Agreement and all communications between the Parties will be conducted in that language.
15.15. Construction . Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word or has the inclusive meaning represented by the phrase and/or. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Schedules and Exhibits or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms including, include(s), such as, and for example as used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by without limitation.
IN WITNESS WHEREOF, this has been duly executed by authorized representatives of the Parties on the first date first written above.
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Schedule 1.33
Deed of Adherence
THIS DEED is made on [ · ]
BETWEEN:
(1) [ · ] ( Transferor ); and
(2) [ · ] ( New Party )
WHEREAS:
(A) The New Party has agreed to acquire [ · ] Shares representing the Transferors complete holding in Nutrition Science Partners Limited from the Transferor (the Acquired Interest ).
(B) The New Party will adhere to an agreement entitled Joint Venture Agreement dated [ · ] and made between Hutchison MediPharma (Hong Kong) Limited, Nestlé Health Science S.A., Nutrition Science Partners Limited and Hutchison China MediTech Limited (the Joint Venture Agreement ) by which the Parties agreed provisions relating to the ownership of the Company and the conduct of its business.
NOW THIS DEED WITNESSETH AND IT IS HEREBY AGREED:
1. DEFINITIONS AND INTERPRETATIONS
1.1 Definitions
In this Deed, unless the subject or context otherwise requires, words defined in the Joint Venture Agreement will have the same meanings when used herein.
1.2 Interpretation
The provisions of Section 15.15 of the Joint Venture Agreement will apply to this Deed mutatis mutandis unless otherwise defined in this Deed.
1.3 Headings
Headings will be ignored in the construction of this Deed.
2. REPRESENTATIONS AND WARRANTIES
The New Party represents and warrants to (a) the Transferor and (b) each Party to the Joint Venture Agreement, including any Person who is a Party to the Joint Venture Agreement pursuant to the execution of a Deed of Adherence (to the extent such party has not transferred all of its Shares to another Person) (the Existing Parties ) as follows:
2.1 Status
It is a company duly established and existing under the laws of the jurisdiction stated on page 1 of this Deed and has the power and authority to own its assets and to conduct the business which it conducts and/or proposes to conduct.
2.2 Powers
It has the power (a) to enter into, exercise its rights and perform and comply with its obligations under this Deed and (b) to act as a Shareholder of the Company.
2.3 Authorisation and Consents
All actions, conditions and things required to be taken, fulfilled and done (including the obtaining of necessary consents) in order (a) to enable it lawfully to enter into, exercise its rights and perform and comply with its obligations under this Deed and the Joint Venture Agreement are valid, legally binding and enforceable and (b) to make this Deed and the Joint Venture Agreement admissible in evidence in the courts of the jurisdiction in which it is incorporated have been taken, fulfilled and done.
2.4 Non-Violation of Laws etc.
Its entry into, exercise of its respective rights and/or performance of or compliance with its respective obligations under this Deed and the Joint Venture Agreement and the purchase of the Acquired Interests do not and will not violate or exceed any restriction imposed by (a) any Applicable Laws binding on it to which it is subject or (b) its memorandum and articles of association or equivalent constitutional documents.
2.5 Obligations Binding
Its obligations under this Deed and the Joint Venture Agreement are valid, binding and enforceable.
2.6 Non-Violation of Other Agreements
Its entry into, exercise of its rights and/or performance of or compliance with its respective obligations under this Deed and the Joint Venture Agreement and the purchase of the Acquired Interests do not and will not violate any agreement to which it is bound.
3. UNDERTAKINGS OF THE NEW PARTY
The New Party confirms that it has been supplied with a copy of the Joint Venture Agreement and undertakes to the Transferor and each of the Existing Parties that it will:
(a) with effect from the time of completion of the Transfer of the Acquired Interests to it (the Transfer Date ), assume, perform and comply with each of the obligations of the Transferor under the Joint Venture Agreement to the extent of the Acquired Interest as if it had been a party to the Joint Venture Agreement at the date of execution thereof; and
(b) as soon as possible and in any event no later than five (5) Business Days of the Transfer Date (i) notify the Existing Parties of the completion of the Transfer of the Acquired Interests to it and (ii) provide a copy of this Deed duly executed by the New Party and the Transferor to each of the Existing Parties.
Nothing in this Deed shall release the Transferor from any liability in respect of any obligations under the Joint Venture Agreement due to be performed prior to the Effective Date.
4. NOTICES
The address and facsimile number designated by the New Party for the purposes of Section 15.4 ( Notices ) of the Joint Venture Agreement are:
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5. ASSIGNMENT AND TRANSFER
The parties hereto hereby acknowledge and agree that, save as provided in the Joint Venture Agreement, neither party will have any right to assign, transfer or in any way dispose of the benefit (or any part thereof) or the burden (or any part thereof) of this Deed without the prior written consent of the other party.
6. THIRD PARTY RIGHTS
No term of this Deed is enforceable under the Contracts (Rights of Third Parties) Act 1999, by a Person who is not a party to this Deed, save for any of the Existing Parties who is not a party to this Deed.
7. GENERAL PROVISIONS
The provisions of ARTICLE XII and Sections 15.1 , 15.4 , 15.7 , 15.9 , 15.10 , and 15.11 of the Joint Venture Agreement will apply mutatis mutandis to this Deed as if expressly set out herein.
IN WITNESS WHEREOF, this deed has been duly executed by authorized representatives of the Parties and is intended to be and hereby is delivered on the date first written above.
Schedule 1.44
Fair Market Price Calculation
1. Definition of Fair Market Value
1.1 Fair Market Value means the fair market value of the Shares (expressed as an amount in US Dollars per Share) based on the value of the Company (including all assets, liabilities and shareholder loans) calculated using a discounted cash flow (DCF) basis as the primary approach to be validated by an EBITDA valuation multiple of market comparables and based on the following assumptions:
1.1.1 on the basis of a sale and purchase between a willing seller and willing buyer made on commercial terms and on an arms length basis;
1.1.2 the Fair Market Value will be determined as at the date both initial agreed valuers have been appointed; and
1.1.3 shareholder loans (other than short term shareholder loans) will be treated as share capital in the valuation of the Company provided that such shareholder loans have been granted by both Shareholders or their respective Affiliates in accordance with their Ownership Percentages.
1.2 When determining the Fair Market Value as calculated in accordance with the above principles, the below assumptions will apply:
1.2.1 that all Shares are capable of transfer without restrictions with all rights and privileges attaching thereto and free from all encumbrances; and
1.2.2 that no additional or reduced value is attached to any contractual rights provided for in this Agreement or whether the Shares attract a premium or discount by virtue of them representing a majority or minority shareholding interest respectively.
2. Determination of Fair Market Value
2.1 Each of Nestlé and Hutchison will appoint one (1) investment bank or accounting firm of international repute with expertise in valuing companies with similar businesses as the business of the Company and the ability to perform a valuation of the Company (each, an Initial Agreed Valuer ).
2.2 The two Initial Agreed Valuers will be each instructed independently to determine the Fair Market Value within [**] days of their appointment and will each deliver their respective reports simultaneously to the other Shareholder and the Board.
2.3 In the event that the lower valuation provided by the two Initial Agreed Valuers differs by more than [**] from the higher valuation (a Material Discrepancy ), unless the Shareholders agree otherwise, a third valuation will be performed by an investment bank or accounting firm of international repute with expertise in valuing businesses similar to the business of the Company and the ability to perform a valuation of the Company, appointed either:
2.3.1 by the mutual agreement of the Shareholders; or
2.3.2 where the Shareholders cannot agree, by mutual agreement of the two Initial Agreed Valuers,
(the Third Valuer ; the Third Valuation ).
2.4 Where an Initial Agreed Valuer or the Third Valuer submits a range as a valuation, the median of that range will be deemed to be the valuation submitted by such Initial Agreed Valuer or Third Valuer. For the avoidance of doubt, all comparisons of valuations will be made by comparing the absolute dollar terms given for each valuation.
2.5 Unless there is a Material Discrepancy, the arithmetic mean of the amounts determined by the two Initial Agreed Valuers will be the Fair Market Value.
2.6 Where a Third Valuer is appointed, the Fair Market Value will be the average of the two valuations which are closest together or, where the greatest and the smallest valuations are equidistant with regards to the average estimate, the midpoint between such valuations.
2.7 The Fair Market Value established under this Schedule 1.44 will be final and binding on, and cannot be appealed by, any Party.
2.8 The costs of undertaking the determination of Fair Market Value in accordance with this Schedule 1.44 will be shared equally by the Shareholders.
Schedule 1.52
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Introduction
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Production & Processing
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Mechanism of Action
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Schedule 1.53
HMPL-004 Warranties
a. The Company is the sole and exclusive owner of, and has the sole right, title and interest in and to, the Acquired Technology, in each case free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien, lease, sublease, option, or charge of any kind, limitations on transfer or any subordination arrangement in favor of a Third Party;
b. The Acquired Technology comprises all of the Intellectual Property Rights forming HMPL-004 and all of the Intellectual Property Rights Controlled by the Company, its Affiliates, consultants and contractors that is necessary or useful for the use, the Development or Commercialization of HMPL-004 or the Products;
c. All of the Acquired Patent Rights are in force or pending and have not been abandoned as of the Effective Date, and all such Acquired Patent Rights are valid and enforceable without any claims, challenges, oppositions, interference or other proceedings pending or, to the knowledge of the Company, Hutchison and their Affiliates and the key employees and consultants involved in the Development of HMPL-004, threatened and the Company, Hutchison or their Affiliates have filed and prosecuted patent applications within the Acquired Patent Rights in good faith and complied with all duties of disclosure with respect thereto, and neither the Company or Hutchison have and their Affiliates have not initiated or been involved in any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any Acquired Technology, nor have any such proceedings been threatened by the Company, Hutchison or an Affiliate, nor does the Company, Hutchison or an Affiliate know of any valid basis for any such proceedings;
d. The Company has the right to use and disclose (in each case under appropriate conditions of confidentiality) the Acquired Know-How free from encumbrances;
e. To the knowledge of the Company, Hutchison, their Affiliates and the key employees and consultants involved in the Development of HMPL-004, the Development of HMPL-004 and/or the Products, in the form in which it is being Developed by the Company, Hutchison or their Affiliates as of the Effective Date, does not infringe or misappropriate any Patent Rights of a Third Party;
f. No Third Party has challenged or has threatened in writing to challenge the extent, validity or enforceability of the patents encompassed within the Acquired Technology (including, by way of example, through the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the US Patent and Trademark Office or any analogous foreign entity), and all application, registration, maintenance and renewal fees in respect of the Acquired Patent Rights have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Acquired Patent Rights have been filed;
g. There are no claims, judgments or settlements pending against the Company, Hutchison or their Affiliates with respect to any Acquired Technology, and neither the Company or Hutchison have, and their Affiliates have not, received notice that any such claims, judgments or settlements are threatened or of any infringement or misappropriation by the Company, Hutchison or an Affiliate of Hutchison or the Company of the Intellectual Property Rights including Patent Rights of a Third Party;
h. None of the Company, Hutchison or their Affiliates have granted any Third Party, including any academic organization or agency, any rights to the Acquired Technology, HMPL-004 or the Products, or any other rights that would otherwise interfere or be inconsistent with the Companys rights hereunder, and there are no agreements or arrangements to which the Company, Hutchison or any of their Affiliates is a party relating to the Products, HMPL-004, the Acquired Patent Rights, or the Acquired Know- How that would limit the rights granted to the Company or that restrict or will result in a restriction on the Companys ability to Develop, register, use, manufacture or Commercialize HMPL-004 or the Products;
i. No officer or employee of the Company, Hutchison or an Affiliate is subject to any agreement with any other Third Party which requires such officer or employee to assign any interest in any Acquired Technology relating to HMPL-004 or the Products to any Third Party;
j. All of Hutchisons and their Affiliates, employees, officers, and consultants who have been involved with the Acquired Technology have executed agreements or have existing obligations under Applicable Laws requiring assignment to the Company of all inventions made during the course of and as the result of their association with the Company, Hutchison or an Affiliate and obligating the individual to maintain as confidential Hutchisons Confidential Information as well as Confidential Information of other parties (including Nestlé and its Affiliates) which such individual may receive, to the extent required to support the Companys or Hutchisons obligations under this Agreement and all inventions relevant to the rights granted to the Company under this Agreement have been duly transferred to the Company in accordance with such agreements or existing obligations and Applicable Laws or Hutchison has entered into binding agreements within the Company permitting such a transfer;
k. The Company, Hutchison and their Affiliates have taken all reasonable precautions to preserve the confidentiality of the Acquired Know-How;
l. None of the Company, Hutchison or their Affiliates have committed any act, or omitted to commit any act, that may cause the Acquired Patent Rights to expire prematurely or be declared invalid or unenforceable;
m. None of the Company, Hutchison or their Affiliates have entered into a government funding relationship that would result in rights to HMPL-004 or any Product residing with any Third Party, including in the US Government, National Institutes of Health, National Institute for Drug Abuse or other agency, and the licenses granted hereunder are not subject to overriding obligations to the US Government as set forth in Public Law 96-
517 (35 U.S.C. 200-204), as amended, or any similar obligations under the laws of any other country;
n. None of the Company, Hutchison nor any employee, agent or subcontractor of the Company, Hutchison or their Affiliates involved in the Development of HMPL-004 or the Products has been debarred under subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); and
o. The Company, Hutchison and their Affiliates are in compliance, and have at all times complied, with all Applicable Laws relating to the Acquired Technology, including Applicable Laws relating to export restrictions and controls and biodiversity (including the 1992 United Nations Convention on Biological Diversity and the 2011 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization).
p. Each of the warranties will be separate and independent and (unless expressly provided otherwise) will not be limited by reference to any other warranty or by anything in this Agreement.
Schedule 2.1
Part 1
Hutchisons Obligations on Completion
On or before the Completion Date, Hutchison will:
1. Procure that shareholders resolutions of the Company are held at which:
1.1 Ernst & Young (or such other auditor as agreed between the Shareholders) will be appointed as auditors of the Company; and
1.2 the capital of the Company is increased from ten thousand Hong Kong dollars (HK$10,000) divided into ten thousand (10,000) Shares of one Hong Kong dollar (HK$1) each to twenty thousand Hong Kong dollars (HK$20,000) divided into twenty thousand (20,000) Shares of one Hong Kong dollar (HK$1) each.
2. Procure that Board resolutions of the Company are passed pursuant to which:
2.1 the Directors will allot and issue ten thousand (10,000) Shares credited as fully paid to Nestlé, in consideration for the payment of the Subscription Price;
2.2 it will be resolved to enter Nestlé in the register of members as holder of ten thousand (10,000) Shares and to issue a share certificate to Nestlé in respect of such Shares;
2.3 the Initial Development Plan will be adopted;
2.4 the Initial Budget will be adopted;
2.5 [**] will be appointed as Directors;
2.6 the Directors are authorised to allot and issue ten thousand (10,000) Shares to Nestlé credited as fully paid; and
2.7 Ancillary Agreements and the Option Agreement in the agreed terms will be approved and entered into by the Company and delivered to the Shareholders.
3. Waive, or agree to procure the waiver of, any rights or restrictions which may exist in the Articles of Incorporation of the Company or otherwise which might prevent the allotment and issue of the Shares in accordance with this Schedule.
4. Deliver to Nestlé and to the Company executed counterpart originals of the Option Agreement and each Ancillary Agreement.
5. Procure that the Company delivers to Nestlé and to Hutchison executed counterpart originals of the Option Agreement and each Ancillary Agreement.
Part 2
Nestlés Obligations on Completion
On the Completion Date, Nestlé will:
1. Procure that counterpart originals of the following agreements are executed and delivered to the Company:
1.1 Nestlé Services Agreement
1.2 Option Agreement
2. Procure that the Company delivers to Nestlé and to Hutchison executed counterpart originals of the Option Agreement and each Ancillary Agreement.
3. In consideration for Shares in the Company and the injection by Hutchison and/or its Affiliates to the Company of the Hutchison Business by (i) the granting of exclusive rights over the Hutchison Library and Hutchison Botanical R&D Platform in the Research Field pursuant to the Research and Development Collaboration Agreement and (ii) the Company owning the Intellectual Property relating to HMPL-004, subscribe unconditionally for ten thousand (10,000) Shares and pay the Subscription Price to the Company by electronic transfer in immediately available cleared funds.
Schedule 3.2.2
Matters Managed by the Product Development Subcommittee
All decisions involving the development strategy of the Company including, without limitation:
1. Preparing a draft of the Development Plan and/or any amendments or updates thereto, for adoption by the Board;
2. Preparing a draft of the Development Budget and/or any amendments or updates thereto, for adoption by the Board;
3. Reviewing additional potential Development project(s), including a new Product, introduced by a Shareholder as a Third Party;
4. Preparing and reviewing all drug candidate selection decisions;
5. Preparing all decisions related to the progression of a Product to the next stage of Clinical Trials;
6. Reviewing and making recommendations for the discontinuation of the Development of a Product; and
7. Broadening and/or changing indications for Products.
Schedule 7.32
Board Approval Matters
1. Deciding on any matters set out in Schedule 3.2.2 upon recommendation of the Product Development Subcommittee;
2. Deciding on any matters on which the Product Development Subcommittee cannot agree;
3. Deciding on any matters on which the Research Collaboration Subcommittee (as detailed in the Research and Development Collaboration Agreement) cannot agree;
4. Deciding on any matters on which the IPR Subcommittee cannot agree;
5. Setting overall objectives and strategic plans related to the JV Activities (including the scope and location of such JV Activities) and the Companys business and investments;
6. Reviewing and changing the scope or location of the JV Activities and/or any variants to and/or termination of any Ancillary Agreements, the Option Agreement or any License Agreement;
7. Reviewing and approving, as applicable, the Development Plan (including the budgets therein and the Research Plan), and any amendments or revisions thereto (including the frequency of amendments to the Development Plan);
8. Reviewing and approving as applicable, the Budget and the Development Budget and any amendments or revisions thereto;
9. Monitoring the Companys performance against the then-current Development Plan and plans for the Manufacture and Commercialization of Products;
10. Developing and reviewing the Intellectual Property and litigation strategy for the Company;
11. Evaluating all material potential transactions for the Company and determining whether, and on what terms, such transaction will be pursued;
12. Subject to Applicable Laws and as authorized by the shareholders meeting, allotting new Shares of the Company and the admission of new holders of Shares of the Company;
13. The declaration of dividends, if any, to the holders of Shares of the Company;
14. Deciding to proceed with new or additional Research or Development with respect to existing Products or potential Products;
15. Deciding the terms of any licensing of any Products or Intellectual Property Rights to any Shareholders and/or to any Third Party;
16. Deciding whether the Company should use any tradenames in connection with its activities;
17. Reviewing and deciding on any terminations of product development recommended by the Product Development Subcommittee;
18. Evaluating and deciding on any additional funding (including the form of the funding) required by the Company;
19. Subject to the terms of this Agreement, determining the price to be paid for any newly issued Shares or Share Equivalents;
20. Determining the powers, duties and remuneration of the General Manager and the Finance Director;
21. Deciding whether to enforce any Ancillary Agreement, the Option Agreement, any License Agreement or any other obligations owed to the Company;
22. Reviewing and approving as applicable, the Research Plan and any amendments or revisions thereto;
23. Reviewing and approving (i) the annual budget detailing the projected costs for a Calendar Year of the Company, and (ii) the [**] years rolling strategic budget under the Research and Development Collaboration Agreement, as updated and amended from time to time and any amendments or revisions thereto;
24. Approving any reasonable out-of-pocket costs (including supplies, materials and costs to be incurred by Hutchison or Nestlé to any Third Party) incurred by Hutchison or Nestlé in excess of the costs budgeted in the applicable budget under the Research and Development Collaboration Agreement in connection with performing the activities under the Research and Development Collaboration Agreement; and
25. Determining and approving the Research Field and any amendments thereto; and
26. Such other responsibilities as may be assigned to the Board pursuant to this Agreement or as may be agreed upon by the Shareholders from time to time.
Schedule 7.6.1
Unresolved Matters for Deadlock
Any matter for which, if no actions were taken, there would be a significant detrimental impact on the operations of the Company or Commercialization of any Product including, without limitation, approval of the Budget and the Development Budget.
The unresolved matters under this Schedule will not include any matters referenced to in Section 3.2.5(iv) on which the Board cannot reach agreement.
Schedule 7.6.5
Buy/Sell Procedure
1. Either Shareholder (the Triggering Shareholder ) may serve notice in writing (a Shoot-Out Notice ) on the other Shareholder (the Receiving Shareholder ) offering to purchase (or procure the purchase of) all of the Shares held by the Receiving Shareholder, together with its Affiliates (if any), with full title, free from all encumbrances and together with all rights attaching to them, at a price stated in the Shoot-Out Notice for such Shares (the Shoot-out Price ).
2. A Shoot-Out Notice may not be revoked.
3. If both Shareholders serve a Shoot-Out Notice pursuant to Section 7.6.5 and this Schedule 7.6.5 , the first Shoot-Out Notice served under the terms of Section 15.4 ( Notices ) will be the Shoot-Out Notice for the purposes of this Schedule 7.6.5 and the other notice will be of no effect.
4. Within twenty (20) Business Days of the service of the Shoot-Out Notice, the Receiving Shareholder may serve a notice in writing (a Response Notice ) on the Triggering Shareholder specifying whether the Receiving Shareholder elects:
4.1 to sell (or procure the sale of) all of the Shares which it holds itself, together with its Affiliates (if any), to the Triggering Shareholder at the Shoot-Out Price; or
4.2 to reject the Shoot-Out Notice and notify the Triggering Shareholder instead that the Receiving Shareholder wishes to purchase (or procure the purchase of) all of the Shares held by the Triggering Shareholder, together with its Affiliates (if any), at the Shoot-Out Price.
5. If a Response Notice is not served within twenty (20) Business Days of the service of the Shoot-Out Notice, the Receiving Shareholder will be deemed to have elected to sell (or procure the sale of) all of the Shares held by the Receiving Shareholder, together with its Affiliates (if any), to the Triggering Shareholder at the Shoot-Out Price.
6. The Response Notice will set out the time for completion of the sale and purchase of the relevant Shares which will not be less than two (2) nor more than five (5) Business Days after the date of the Response Notice, save that where no Response Notice is served within the time period of twenty (20) Business Days specified in Section 7.6.5 , completion of the sale and purchase of such Shares will take place at the latest within five (5) Business Days of the expiry of that time period.
Schedule 8.1
Matters Requiring Resolution of the General Meeting of Shareholders
1. Amendment of the Articles of Incorporation;
2. Any change of name of the Company;
3. Issuance of any Shares, Share Equivalents or other equity or equity-linked securities of the Company to a new Third Party investor without giving the existing Shareholders preemptive subscription rights in proportion to their respective Shareholdings, other than for share options or grants to employees;
4. Any material reorganization or change (including cessation) to the nature or scope of the business of the Company, but excluding any such change resulting from the use or development of its existing assets;
5. Any merger, joint venture involving a transfer or license of Intellectual Property by the Company, profit and/or loss sharing partnership, spin-off or any other kind of corporate reorganization involving the Company;
6. Acquisition of assets or equity investment in another Person (including joint ventures) in excess of [**] or its equivalent in any single transaction or series of related transactions;
7. Sale, assignment, exchange, transfer or other disposition of any assets of the Company with a book value or market value exceeding [**] or its equivalent in any single transaction or series of related transactions;
8. Sale, assignment, transfer or other disposition of all or substantially all of the Intellectual Property Rights and other assets for any Product;
9. Taking or instituting any proceeding for voluntary winding-up, dissolution or liquidation of the Company or any Person controlled (as such term is used in Section 1.4) by the Company;
10. Redemption, retirement or repurchase of any Shares, Share Equivalents or other equity or equity-linked securities of the Company;
11. Approval of the amount of dividends available for distribution;
12. Altering the fiscal year or material accounting policies or practices of the Company or changing the external auditors of the Company; and
13. Any other matters reserved to the general meeting of Shareholders by Applicable Laws.
Exhibit A
Initial Development Plan for HMPL-004 and Prioritization of CMC Issues
[**]
[**]
EXECUTION COPY
List of CMC Issues to be addressed for HMPL-004
Key Chemistry, Manufacturing & Control ( CMC ) issues to be addressed for the HMPL-004 project are prioritized as follows:
1) [**]
2) [**]
Note: Refer to the audit report from September 2012 prepared by PAREXEL International for detailed descriptions of the audit findings including additional activities that need to be completed prior to NDA submission.
Article I. [**]
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Est. Completion
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Audit Finding |
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Est. Completion
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1 |
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EXHIBIT B
OPTION AGREEMENT
BY AND AMONG
NUTRITION SCIENCE PARTNERS LIMITED
AND
NESTLÉ HEALTH SCIENCE S.A.
[DATE]
TABLE OF CONTENTS
ARTICLE I. DEFINITIONS |
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3 |
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ARTICLE II . OPTIONS |
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8 |
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ARTICLE III. CONFIDENTIALITY OF INFORMATION |
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16 |
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ARTICLE IV. WARRANTIES; COVENANTS |
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18 |
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ARTICLE V. TERM AND TERMINATION |
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20 |
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ARTICLE VI. MISCELLANEOUS |
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21 |
Schedules, Exhibits And Appendices |
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Schedule 1.18 |
Interim Criteria |
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Schedule 1.39 |
UC Phase 3 First Induction Study Milestone Criteria |
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Exhibit A |
US/Canada License |
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Exhibit B |
Europe License |
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Appendix A |
Option Exercise Notice |
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Appendix B |
Independent Expert Appointment Procedure |
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Appendix C |
Disclosures |
OPTION AGREEMENT
THIS OPTION AGREEMENT (this Agreement ) is entered into as a deed as of the [ · ] day of [MONTH] 201[ · ] (the Effective Date ) by and between:
(1) Nutrition Science Partners Limited, a limited company organized and existing under the laws of Hong Kong with its principal offices at 22/F Hutchison House, 10 Harcourt Road, Central, Hong Kong (the Company ); and
(2) Nestlé Health Science S.A., a company organized and existing under the laws of Switzerland with its principal offices at Rue des Remparts 2, 1095 Lutry, Switzerland ( Nestlé ).
The Company and Nestlé are hereinafter referred to collectively as the Parties and individually as a Party .
WITNESSETH:
WHEREAS, pursuant to a Joint Venture Agreement dated [ · ] November 2012 (the JV Agreement ), Hutchison MediPharma (Hong Kong) Limited, a limited company organized and existing under the laws of Hong Kong ( Hutchison ) and Nestlé agreed to form a joint venture, in part for the purpose of the discovery, development, registration, manufacture and commercialization of Products in the Field subject to applicable anti-trust clearance (the Joint Venture );
WHEREAS, in connection with the Joint Venture, the Company desires to grant to Nestlé, and Nestlé desires to receive, exclusive options to obtain exclusive royalty-bearing licenses to Commercialize Products in the Field in certain territories, on the terms and conditions set forth herein;
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE I.
DEFINITIONS
The terms defined in this Article will have the meanings ascribed to them herein whenever they are used in the Agreement, unless otherwise clearly indicated by the context. Any capitalized terms used in this Agreement and not defined in this Agreement will have the meaning ascribed to them in the JV Agreement.
1.1. Agreement will have the meaning set forth in the introduction.
1.2. Board means the board of directors of the Company.
1.3. Commercialization means any and all activities of using, importing, exporting, marketing, promoting, distributing, offering for sale or selling a Product including pre-
commercial launch market development activities conducted in anticipation of Regulatory Approval of a Product, seeking pricing and reimbursement approvals for a Product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority regarding Post-Approval Clinical Trials, all activities required to fulfill ongoing regulatory obligations, including adverse event reporting and all activities relating to the licensing of a Product (including sourcing and negotiations with potential licensees). When used as a verb, Commercialize means to engage in Commercialization.
1.4. Company will have the meaning set forth in the introduction.
1.5. Company Know-How means, with respect to an Option granted under this Agreement, any Information that is necessary or useful for the development, use or sale of HMPL-004 or any Product.
1.6. Company Patent Rights means, with respect to an Option granted under this Agreement, any Patent Right that is necessary or useful for the development, use or sale of HMPL-004 or any Product.
1.7. Company Technology means collectively, the Company Know-How and Company Patent Rights.
1.8. Development means pre-clinical and clinical activities performed by or on behalf of the Company with respect to Products in an indication in the Field for the purpose of obtaining and maintaining Regulatory Approval with respect to such indication in such jurisdiction and activities performed by or on behalf of the Company with respect to Products destined as medical food products. Development will include, without limitation, all activities related to discovery, research, pre-clinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs, statistical analysis, report writing performed pursuant to the Development Plan with respect to Products. Notwithstanding anything to the contrary in this Agreement, Development will not include Manufacturing or Commercialization. When used as a verb, Develop means to engage in Development.
1.9. Effective Date will have the meaning set forth in the introduction to this Agreement.
1.10. Europe means Austria, Andorra, Belarus, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Gibraltar, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malta, Monaco, Netherlands, Norway, Poland, Portugal, Romania, Russia, San Marino, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey, Ukraine, the United Kingdom and Vatican City.
1.11. Europe License will have the meaning set forth in Section 2.2.1 .
1.12. Europe License Agreement means the agreement, in the form set forth in Exhibit B , setting out in writing the terms of the Europe License.
1.13. Europe Option will have the meaning set forth in Section 2.2.1 .
1.14. Field means any and all uses, including without limitation the treatment, prevention or diagnosis of gastrointestinal diseases, disorders or conditions in humans.
1.15. Generic Product means, on a country-by-country basis and Product-by-Product basis, a product [**].
1.16. Independent Expert Appointment Procedure means the procedure set out in Appendix B for the appointment of an independent Third Party expert.
1.17. Information means any data, results, technology or information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical and clinical test data and data resulting from non-clinical studies), chemistry, manufacturing and controls information, stability data and other study data and procedures.
1.18. Interim Criteria will have the meaning set forth in Schedule 1.18 .
1.19. JV Agreement will have the meaning set forth in the recitals to this Agreement.
1.20. License means each of the Europe License, the ROW License and the US/Canada License.
1.21. License Period means, with respect to any of the Licenses, the period of time during which such License is in force.
1.22. Marketing Authorization means with respect to a Product, the approval from the relevant Regulatory Authority, in a given country or region for the marketing and sale of such Product in such country or region (but excluding any pricing approvals for the sale of such pharmaceutical products).
1.23. Marketing Authorization Application means an application to obtain a Marketing Authorization for a Product which is either (i) issued by the European Medicines Agency through the centralized filing procedures for the marketing and sale of such pharmaceutical product throughout the European Union or (ii) issued by the applicable local Regulatory Authority in two or more of the following countries: the United Kingdom, France, Germany, Italy and Spain, through the decentralized filing procedures for the marketing and sale of such Product in such country; provided that such Marketing Authorization is for the particular indication or indications in humans for which such pharmaceutical product will be sold by the Company (or, as applicable, Nestlé, its Affiliates or sublicensees) in the relevant country.
1.24. Nestlé will have the meaning set forth in the introduction to this Agreement.
1.25. Net Sales means, on a country-by-country and Product-by-Product basis, the gross amounts invoiced by Nestlé, its sublicensees or its Affiliates, as applicable, to Third Parties for sales of a Product in the Field in such country, less the following deductions to the extent included in the gross invoiced sales price for such Product or otherwise paid or incurred by Nestlé, its sublicensees or its Affiliates with respect to the sale of such Product in such country:
a) [**]
b) [**]
c) [**]
d) [**]
e) [**]
f) [**]
[**].
Notwithstanding the foregoing, in the event a Product is sold as a combination product that includes HMPL-004 and an active agent that is not HMPL-004 (such combination product, the Combination Product ), Net Sales will be calculated by multiplying the Net Sales of the Combination Product by the fraction A/(A+B), where A is the gross average invoice price of the Product during the relevant Calendar Quarter if sold separately in a country and B is the gross average invoice price of the other product(s) included in the Combination Product during the relevant Calendar Quarter if sold separately in such country. In the event no such separate sales are made by Nestlé, its Affiliates or sublicensees in a country, Net Sales of the Combination Product will be calculated in a manner to be negotiated and agreed upon by the Parties, reasonably and in good faith, prior to any sale of such Combination Product, which will be based upon the respective cost of goods sold of the active components of such Combination Product.
1.26. Option will mean any of the following: (a) the US/Canada Option, (b) the Europe Option and (c) any ROW Country Option.
1.27. Option Completion Date will mean the 10th Business Day after (but not including) (a) the date on which the Option Exercise Notice in respect of the relevant Option was submitted to the Company, or (b) in respect of the US/Canada Option only and in the event the US/Canada Option has not already been exercised by Nestlé at such time, the date on which the Board delivers to Nestlé written confirmation of the achievement of the UC Phase 3 First Induction Study Milestone, or (c) in respect of the ROW Country Option only, the date on which the Parties have agreed the terms of the ROW License Agreement in respect of such country or countries in respect of which the ROW Country Option is being exercised, provided that, in each
case, the Option Completion Date will be extended to provide for the satisfaction of any applicable regulatory approvals (if any).
1.28. Option Exercise Notice will mean a written notice, substantially in the form set out in Appendix A , provided by Nestlé to the Company as notice of Nestlés exercise of an Option.
1.29. Option License Agreement means any of the Europe License, US/Canada License and ROW License upon the exercise of an Option by Nestlé hereunder.
1.30. Option Period will mean (a) with respect to the US/Canada Option, the period beginning on the Effective Date and ending on [**] and (b) with respect to the Europe Option and the ROW Country Option, the period beginning on the Effective Date and ending on [**].
1.31. Party or Parties will have the meaning set forth in the introduction to this Agreement.
1.32. Products means any pharmaceutical product, food supplement or medical food product in finished form that contains HMPL-004, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.
1.33. ROW means all countries of the world other than the US, Canada and Europe (as defined in this Agreement).
1.34. ROW Country Option will have the meaning set forth in Section 2.3.1 .
1.35. ROW License will have the meaning set forth in Section 2.3.1 .
1.36. ROW License Agreement means the agreement to be negotiated between the Parties setting out in writing the terms of the ROW License for specific country or countries in a form, to the extent reasonably practicable, substantially similar to the US/Canada License Agreement and the Europe License Agreement.
1.37. Term will have the meaning set forth in Section 5.2 .
1.38. Third Party means any Person other than Nestlé and its Affiliates and the Company and its Affiliates.
1.39. UC Phase 3 First Induction Study Milestone means the successful achievement of [**] as per the development criteria set forth in Schedule 1.39 .
1.40. US means the United States of America.
1.41. US/Canada Interim Payment will have the meaning set forth in Section 2.1.3 .
1.42. US/Canada License will have the meaning set forth in Section 2.1.1 .
1.43. US/Canada License Agreement means the agreement, in the form set forth in Exhibit A , setting out in writing the terms of the US/Canada License.
1.44. US/Canada Option will have the meaning set forth in Section 2.1.1 .
1.45. Withholding Taxes will have the meaning set forth in Section 2.7.2(i) .
ARTICLE II.
OPTIONS
2.1. US and Canada Option .
2.1.1 General . Subject to the terms of this Agreement, the Company hereby grants to Nestlé an exclusive option to obtain an exclusive royalty-bearing license under the Company Technology on the terms set out in the US/Canada License Agreement (the US/Canada License ), to Commercialize Products in the Field in the US and Canada (the US/Canada Option ).
2.1.2 Exercise of Option .
(i) Subject to the US/Canada Option not having been exercised pursuant to Section 2.1.3 , Nestlé may exercise the US/Canada Option at any time during the Option Period for the US/Canada Option by providing the Company with a signed Option Exercise Notice to so exercise the US/Canada Option; provided that, regardless of delivery of such notice by Nestlé, such US/Canada Option will be deemed automatically exercised upon the Board delivering to Nestlé written confirmation of the successful achievement of the UC Phase 3 First Induction Study Milestone during the Option Period for the US/Canada Option. In the event that the Company cannot reach a decision on whether the UC Phase 3 First Induction Study Milestone has been achieved, the Company may elect for such determination to be performed by an independent Third Party expert mutually appointed by the Parties in accordance with the Independent Expert Appointment Procedure. If such independent Third Party expert determines that the UC Phase 3 First Induction Study Milestone has been achieved, such determination will be final and binding on the Company and Nestlé and Nestlé will be deemed to have exercised the US/Canada Option. The costs of such independent Third Party expert will be borne by the Company. As consideration for exercising the US/Canada Option pursuant to this Section 2.1.2 and the grant of the US/Canada License on the Option Completion Date for the US/Canada Option as set forth below,
Nestlé will pay to the Company a one-time, non-refundable and non-creditable option exercise payment of [**] pursuant to Section 2.1.2(ii) .
(ii) On or before the Option Completion Date for the US/Canada Option, subject to, (i) there being no (a) material breach to the representations and warranties set out in the US/Canada License and Section 4.2 , (b) material disclosures against such representations and warranties as set out in Appendix C (as updated) as the case may be, and/or (c) material disclosures against any representations and warranties set out in the US/Canada License Agreement, (ii) the performance of the obligations and grant of rights under the US/Canada License not being restricted or prohibited under any Applicable Laws (including any export controls) and/or (iii) clearance under any applicable anti-trust rules, Nestlé will pay to the Company the option exercise payment due pursuant to Section 2.1.2(i) and, simultaneously with such payment:
(A) the Company grants to Nestlé the US/Canada License; and
(B) the Parties undertake to execute the US/Canada License Agreement.
(iii) If (A) Nestlé has not delivered a signed Option Exercise Notice to exercise the US/Canada Option in writing by (and including) the last day of the Option Period for the US/Canada Option and the UC Phase 3 First Induction Study Milestone has not been achieved or (B) Nestlé does deliver a signed Option Exercise Notice to exercise the US/Canada Option and does not pay the applicable option exercise payment for the US/Canada Option to the Company by or on the Option Completion Date for the US/Canada Option (and has not remedied such failure to pay within [**] Business Days), then the US/Canada Option will expire and, as of such expiration, the Company will be under no further obligations to offer or grant Nestlé any rights hereunder or otherwise under the Company Technology to Commercialize Products in the Field in the US or Canada.
2.1.3 Interim Analysis .
(i) |
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2.1.4 Information regarding Product Development . The Company will provide to Nestlé on a quarterly basis, a report detailing the progress of any Products in pre-clinical or clinical development by the Company. Upon Nestlés request, the Company will promptly procure Nestlé with access to relevant premises, books, records (including raw data and any correspondence with any Regulatory Authority), databases, staff and consultants of the Company seconded to or working for the Company for the purposes of undertaking due diligence on Products in pre-clinical or clinical development by the Company and will provide copies of all agreements and other documents related to any Products that are material to the Development and Commercialization of the Products in the US and Canada. All information disclosed to Nestlé pursuant to this Section 2.1.4 will be treated by Nestlé as the Companys Confidential Information in accordance with the provisions of ARTICLE III of this Agreement.
2.1.5 Company Undertaking . The Company undertakes to Nestlé that all pre-clinical or clinical development by the Company relevant to the Development and Commercialization of the Products in the US and Canada have been and will be undertaken in facilities which have satisfied FDA requirements for such Development or Commercialization facilities and work.
2.2. Europe Option .
2.2.1 General . Subject to the terms of this Agreement, the Company hereby grants to Nestlé an exclusive option to obtain an exclusive royalty bearing license under the Company Technology on the terms set out in the Europe License Agreement (the Europe License ), to Commercialize Products in the Field in Europe (the Europe Option ).
2.2.2 Exercise of Option .
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2.2.3 Information regarding Product Development . The Company will provide to Nestlé on a quarterly basis, a report detailing the progress of any Products in pre-clinical or clinical development by the Company. Upon Nestlés request, the Company will promptly procure Nestlé with access to relevant premises, books, records (including raw data and any correspondence with any Regulatory Authority), databases, staff and consultants of the Company, seconded to or working for the Company for the purposes of undertaking due diligence on Products in pre-clinical or clinical development by the Company and will provide copies of all agreements and other documents related to any Products that are material to the Development and Commercialization of Products in Europe. All information disclosed to Nestlé pursuant to this Section 2.2.3 will be treated by Nestlé as the Companys Confidential Information in accordance with the provisions of ARTICLE III of this Agreement. The Board undertakes to notify Nestlé at least [**] month in advance of the commencement of the [**] month period prior to the estimated submission date of the Marketing Authorization Application in Europe, such estimate to be reasonable and made in good faith by the Board.
2.2.4 Company Undertaking . The Company undertakes to Nestlé that all pre-clinical or clinical development by the Company relevant to the Development and Commercialization of the Products in Europe have been and will be undertaken in facilities which have satisfied European Medicines Agency requirements for such Development or Commercialization facilities and work.
2.3. ROW Country Option .
2.3.1 General . Subject to the terms of this Agreement, the Company hereby grants to Nestlé an exclusive option to obtain an exclusive license under the Company Technology (the ROW License ) to Commercialize Products in the Field in each country in the ROW (the ROW Country Option ).
2.3.2 Exercise of Option .
(i) Nestlé may exercise the ROW Country Option in respect of one or more countries in the ROW at any time during the Option Period (and therefore may exercise the ROW Country Option multiple times during the Option Period for the ROW Country Option, each time for a particular country or countries in the ROW) by providing the Company with a signed Option Exercise Notice specifying the country or countries in the ROW in respect of which the ROW Country Option is being exercised.
(ii) [**].
(iii) [**].
(iv) [**].
(v) [**].
2.3.3 Information regarding Product Development . The Company will provide to Nestlé on a quarterly basis, a report detailing the progress of any Products in pre-clinical or clinical development by the Company. Upon Nestlés request, the Company will promptly procure Nestlé with access to relevant premises, books, records (including raw data and any correspondence with any Regulatory Authority), databases, staff and consultants of the Company, seconded to or working for the Company for the purposes of undertaking due diligence on Products in pre-clinical or clinical development by the Company and will provide copies of all agreements and other documents related to any Products that are material to the Development and Commercialization of Products in the ROW. All information disclosed to Nestlé pursuant to this Section 2.3.3 will be treated by Nestlé as the Companys Confidential Information in accordance with the provisions of ARTICLE III of this Agreement.
2.4. No Implied Licenses . Except as explicitly set forth in this Agreement, neither Party will be deemed by estoppel or implication to have granted the other Party any license or other right to any Intellectual Property of such Party.
2.5. Company Restrictions . Subject to Section 2.6 , until expiration of the last-to-expire Option Period, the Company will not, and will cause its Affiliates and its and their respective directors, officers and representatives not to, directly or indirectly: (i) solicit, discuss, negotiate, or enter into any agreement or arrangement with any Third Party regarding the Products; or (ii) solicit, discuss, negotiate, or enter into any agreement or arrangement with any Third Party regarding the Company Technology or all or any portion of the Companys Intellectual Property which relates to or includes Company Technology insofar and to the extent such agreement or
arrangement relates to the Products; provided that the restrictions set forth in this Section 2.5 will not apply to (a) manufacturing agreements or arrangements or any other agreement or arrangements contemplated by an Ancillary Agreement or (b) any country or countries for which the relevant Option Period has expired or has been terminated and no license has been granted.
2.6. Third Party Offers . If the US/Canada Option has not been exercised by Nestlé by [**], the Company may seek potential Third Parties who would be interested in licensing HMPL-004 in the US and/or Canada, including discussing the financial terms of such license. The Company will keep Nestlé updated of such discussions and will notify Nestlé of any formal offer to license HMPL-004 received from any Third Party. For the avoidance of doubt, until the termination of the US/Canada License the Company will not enter or agree to enter into any agreement which may affect or prevent the exercise by Nestlé of the US/Canada Option or the consummation of the US/Canada License.
2.7. Payment Details and Tax .
2.7.1 General . Nestlé will pay or procure the payment of all the Option exercise payments under this ARTICLE II by telegraphic transfer in immediately available funds to an account of the Company (such account being nominated in writing by the Company to Nestlé no later than five (5) Business Days before the relevant Option Completion Date).
2.7.2 Taxes and Withholding .
(i) [**].
(ii) [**].
(iii) [**].
(iv) [**].
(v) [**].
ARTICLE III.
CONFIDENTIALITY OF INFORMATION
3.1. Confidentiality . Each Receiving Party agrees to keep in strict confidence all Confidential Information that the Disclosing Party provides, communicates or otherwise makes available to the Receiving Party and to protect the Confidential Information with the same degree of care normally used to protect its own Confidential Information of a similar nature. The Receiving Party will not disclose or allow disclosure of any Confidential Information to any Third Party and will not use any Confidential Information in any manner, except, in each case, for the purposes of implementing and enforcing this Agreement, the JV Agreement, each License or any Ancillary Agreement, without the prior written consent of the Disclosing Party.
3.2. Exceptions . The restrictions and obligations set forth in Section 3.1 , 3.3 and 3.4 will not apply to any Confidential Information:
3.2.1 which is or becomes generally available to the public through no fault on the part of the Receiving Party;
3.2.2 which is lawfully in the possession of the Receiving Party (other than pursuant to the terms of this Agreement, the JV Agreement, each License, any Ancillary Agreement or any other related agreement), without restriction as to its disclosure,
prior to the disclosure of such information by or on behalf of the Disclosing Party or the Company, as reasonably evidenced by appropriate documentation;
3.2.3 which lawfully becomes available to the Receiving Party from a source other than the Disclosing Party and the Company without any duty as to confidentiality or non-use;
3.2.4 which is independently developed or otherwise created by the Receiving Party (other than pursuant to the terms of this Agreement, the JV Agreement, each License, any Ancillary Agreement or any other related agreement) without the use of any Confidential Information of the Disclosing Party, as reasonably evidenced by appropriate documentation; or
3.2.5 which is required to be disclosed or provided to any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) (i) pursuant to any Applicable Laws, judgment, decree or order; (ii) as necessary to make regulatory filings and communications related to HMPL-004 or any Products; or (iii) for the purpose of asserting or defending against any claims relating to Intellectual Property Rights, including, in particular, any action taken to protect and enforce Intellectual Property Rights; provided , however , that (x) any such information disclosed pursuant to this Section 3.2.5 will be disclosed only to the extent required by Applicable Laws, judgment, decree or order; (y) except with respect to required disclosure to tax authorities, the Party seeking to disclose or provide such information will give the other Parties prompt written notice of such requirement and fully cooperate with the other Parties so that the other Parties and/or the Company (as the case may be) may obtain reasonable assurances that confidential treatment will be accorded to such information; and (z) without limiting the generality of the foregoing, the Parties will use commercially reasonable efforts to ensure that, subject to Applicable Laws, the list of the Products is redacted from any copy of this Agreement, the JV Agreement, each License and any Ancillary Agreement required to be filed with any government or regulatory body.
3.3. Measures to Keep Confidentiality . Each Party agrees that, prior to giving access to any Confidential Information to any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, advisors, consultants and agents, it will require each such Person to agree to be bound by all obligations of confidentiality and non-use under this ARTICLE III , and will take all reasonable steps and measures to ensure that each such Person will enter into a confidentiality undertaking to comply with and perform such obligations, in each case to the same extent as if they were direct parties to this Agreement. The Company further undertakes to take reasonable precautions to protect the confidentiality of any Confidential Information included in the Company Technology.
3.4. Survival of Obligations . The obligations undertaken by the Parties under this ARTICLE III will survive the termination of this Agreement for any reason and will remain in effect and be binding on the Parties for a period of ten (10) years after the termination of this Agreement; provided that to the extent any Confidential Information constitutes a trade secret, as defined in the US Uniform Trade Secrets Act or any Applicable Laws, then the Receiving Party will keep such trade secret confidential until such time as the Confidential Information no longer qualifies as a trade secret under Applicable Laws.
ARTICLE IV.
WARRANTIES; COVENANTS
4.1. Mutual Warranties . As at the Effective Date each Party hereby warrants to the other Party as follows:
4.1.1 It is a company duly organized and validly existing under the laws of its jurisdiction of incorporation. It has all requisite corporate or other applicable power and authority to enter into and perform its obligations under this Agreement;
4.1.2 Its execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on its part. This Agreement has been duly and validly executed and delivered by it and, assuming due and valid authorization, execution and delivery of this Agreement by the other Party, constitutes legally binding obligations enforceable against it in accordance with the terms of this Agreement;
4.1.3 Its execution, delivery and performance of this Agreement do not and will not violate, breach or conflict with (i) its organizational documents, (ii) any law, rule, regulation, judgment, order or decree applicable to it or (iii) any agreement or instrument by which it is bound or to which any of its assets or properties are subject;
4.1.4 No suit, action or other legal proceeding is pending or threatened against it or its Affiliates before any court, arbitration tribunal or other governmental authority, which seeks to disallow, challenge, enjoin, prohibit or impose any damages, penalties or restrictions on, or otherwise make illegal the consummation of, the transactions contemplated by this Agreement, and no investigation that could reasonably be expected to result in any such suit, action or proceeding pending against it;
4.1.5 All other government approvals and all authorizations, consents, approvals and waivers from any Person other than governmental authorities required to be obtained by it in connection with the execution, delivery and performance of this Agreement or the consummation of the transactions contemplated hereby have been duly obtained.
4.2. Warranties by Company . The Company warrants to Nestlé as of the Effective Date and as of each Option Completion Date that except as disclosed by the Company in Appendix C to this Agreement (such Appendix to be updated by the Company by no later than five (5) Business Days before the relevant Option Completion Date):
4.2.1 The Company has the right to grant to Nestlé the rights that the Company purports to grant Nestlé hereunder, including the right to grant exclusive licenses to HMPL-004 and the Products under the Company Technology as set forth herein;
4.2.2 The Company has not granted, and, prior to the expiration of the relevant Option Period, will not during the term of this Agreement grant to any Third Party, including any academic organization or agency, any rights to HMPL-004 or the Products;
4.2.3 All of its employees, officers, seconded employees and consultants have executed agreements or have existing obligations under Applicable Laws requiring assignment to the Company of his or her interest in all inventions made during the course of, and as the result of, their association with the Company which may be licensed to Nestlé pursuant to a License Agreement and obligating the individual to maintain as confidential the Companys Confidential Information as well as Confidential Information of other parties (including Nestlé and its Affiliates) which such individual may receive;
4.2.4 The Company has not granted any Third Party rights that would otherwise interfere or be inconsistent with Nestlés rights hereunder, and there are no license or option agreements or other arrangements to which the Company or any of its Affiliates is a party relating to the Products, HMPL-004, Company Patent Rights, Company Know-How or otherwise that would limit the rights granted to Nestlé under this Agreement (including any License Agreement that may be granted hereunder);
4.2.5 To the Companys knowledge, neither HMPL-004, the Products nor Company Technology infringe or misappropriate, or have infringed or misappropriated the Intellectual Property Rights of any Third Party;
4.2.6 (i) Neither the Company nor to the knowledge of the Company, any employee, agent or subcontractor of the Company involved or to be involved in the development of HMPL-004 or the Products have been debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); (ii) no Person who is known by the Company to have been debarred under Subsection (a) or (b) of Section 306 of said Act will be employed by the Company in the performance of any activities hereunder; and (iii) to the knowledge of the Company, no Person on any of the FDA Clinical Investigator Enforcement Lists (including, but not limited to, the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List) will participate in the performance of any activities hereunder;
4.2.7 Notwithstanding anything to the contrary contained in this Agreement, the Company has not failed to disclose to Nestlé any fact or circumstance known to the Company and relating to any of HMPL-004, the Products or Company Technology that would be reasonably material.
4.3. Covenants of Company . The Company covenants and agrees that during the Term:
4.3.1 neither it, nor any of its Affiliates, will grant any interest to any Third Party in the Company Patent Rights or Company Know-How which is inconsistent with the terms and conditions of this Agreement, the JV Agreement and the other Ancillary Agreements, nor will the Company assign its right, title or interest in or to the Company Patent Rights or Company Know-How to any Third Party in any territory prior to the expiration of the applicable Option Period in such territory;
4.3.2 if, at any time after the execution of this Agreement, it, or any of its Affiliates, becomes aware that it or any of its Affiliates, or its or their employees, agents or subcontractors
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 FDA Clinical Investigator restriction list, it will provide written notice of this to Nestlé within two (2) Business Days of it becoming aware of this fact; and
4.3.3 it will 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 will require any of its Affiliates undertaking any activities under this Agreement to do the same.
4.4. No Other Representations or Warranties . Except as expressly stated in this Agreement, the JV Agreement, the Europe License Agreement, the ROW License Agreement, the US/Canada License Agreement or any Ancillary Agreement, no representations or warranties whatsoever, whether express or implied, including warranties of merchantability, fitness for a particular purpose, non-infringement, or non-misappropriation of Third Party Intellectual Property rights, are made or given by or on behalf of a Party, and all other representations and warranties, whether arising by operation of law or otherwise, are hereby expressly excluded.
ARTICLE V.
TERM AND TERMINATION
5.1. Termination of Options . On or after 31 December 2016, Nestlé will be entitled to terminate (at its discretion) any Option by serving written notice to the Company stating the date of termination of such Option.
Notwithstanding the above, the US/Canada Option will be deemed to have terminated if, pursuant to Section 2.6 , the Company has received a binding offer from a Third Party to license the Company Technology in the US and Canada on terms equal or more favorable than those set out in the US/Canada License and Nestlé has not exercised the US/Canada Option within sixty (60) days from receiving notice pursuant to Section 2.6 of such binding offer to license.
5.2. Term . This Agreement will become effective on the Effective Date and will remain in effect until the earlier of (i) the expiration of all Option Periods for all jurisdictions and, if any Options are exercised by Nestlé hereunder, the execution of all applicable Option License Agreements for all jurisdictions covered by the relevant Option by the Parties; provided that if all Options are exercised by Nestlé for all jurisdictions covered by the relevant Options hereunder, the Agreement will terminate upon the execution of all of the Option License Agreements by the Parties, and (ii) the date on which the Company receives written notice of termination from Nestlé pursuant to Section 5.1 , such notice is not to be sent by Nestlé before 31 December 2016 (such time period, the Term ).
5.3. Effect of Termination or Expiration . Upon the termination or expiration of this Agreement, all rights and obligations of each Party hereunder which do not, by their express terms, survive termination or expiration of this Agreement will be terminated and, for clarity, the Company will be under no further obligations to offer or grant Nestlé any rights hereunder or otherwise under the Company Technology in any country in the world.
ARTICLE VI.
MISCELLANEOUS
6.1. Governing Law, Jurisdiction; Dispute Resolution .
6.1.1 Governing Law . The interpretation and construction of this Agreement will be governed by the laws of England and Wales.
6.1.2 Dispute Resolution . In the event of a dispute arising out of or relating to this Agreement (including regarding its existence, termination or validity) (a Dispute) any Party will provide written notice of the Dispute to the other Parties, in which event the Dispute will be referred to the executive officers of the Shareholders designated below or their successors. The designated officers will use reasonable efforts to attempt resolution by good faith negotiations within thirty (30) days after such notice is received. Said designated officers are initially as follows:
For the Company: The General Manager and the Finance Director
For Nestlé: President and Chief Executive Officer
In the event the designated executive officers do not resolve such Dispute within the allotted thirty (30) days, any Party may, after the expiration of the thirty (30) day period, seek to resolve the Dispute through reference to arbitration in accordance with Section 6.1.3 . Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, will not be deemed a Dispute which may be referred for resolution by the Parties under this Section 6.1.2 .
6.1.3 Arbitration . All Disputes which are unresolved pursuant to Section 6.1.2 and which a Party wishes to have resolved will be referred upon the application of any Party to, and finally settled by, arbitration in accordance with the ICC Arbitration Rules (the Rules ) as in force at the date of this Agreement and as modified by this Section 6.1.3 , which Rules are deemed incorporated into this Section 6.1.3 . The number of arbitrators will be three (3), one of whom will be appointed by each Party and the third of whom, who will act as chairman, will be nominated by the two party-nominated arbitrators, provided that if the third arbitrator has not been nominated within twenty (20) Business Days of the nomination of the second party-nominated arbitrator, such third arbitrator will be appointed by the ICC. The seat of arbitration will be London and the language of arbitration will be English.
The arbitrators will have the power to grant any legal or equitable remedy or relief available under law, including injunctive relief (whether interim and/or final) and specific performance, and any measures ordered by the arbitrators may be specifically enforced by any court of competent jurisdiction. Each Party retains the right to seek interim or provisional measures, including injunctive relief and including pre-arbitral attachments or injunctions, from any court of competent jurisdiction and any such request will not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate. For the avoidance of doubt, this Section 6.1.3 is not intended to limit the powers of the court exercisable in support of arbitration proceedings pursuant to Section 44 of the Arbitration Act 1996 or any Applicable Laws.
6.2. Waiver and Non-Exclusion of Remedies . A Partys failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy will 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
6.3. Notices .
6.3.1 Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be deemed to be given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 6.3.2 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 Section 6.3.1 . Such Notice will be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second (2) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 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.
6.3.2 Address for Notice :
Company:
Nutrition Science Partners Limited
22nd Floor, Hutchison House
10 Harcourt Road, Hong Kong
Attn: The General Manager
Fax: +852 2128 1778
With a copy to:
The Finance Director
c/o Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: General Counsel
Nestlé:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: President and Chief Executive Officer
With a copy to:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: General Counsel
6.4. Entire Agreement . This Agreement, the JV Agreement and any Ancillary Agreement, constitute the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement, the JV Agreement and any Ancillary Agreement supersede all prior agreements, whether written or oral, with respect to the subject matter hereof. 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, the JV Agreement and any Ancillary Agreement. Nothing in this Agreement is intended to limit or exclude any liability for fraud. All Schedules, Exhibits or Appendices 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, Exhibits or Appendices and this Agreement, the terms of any applicable License will prevail.
6.5. Amendment . Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of both Parties.
6.6. Assignability . This Agreement and each and every covenant, term and condition hereof will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Neither this Agreement nor any rights or obligations hereunder may be assigned, delegated or transferred, directly or indirectly, by a Party to any Third Party without the prior written consent of the other Party. The restrictions set out in this Section 6.6 will not apply to any assignment of this Agreement by Nestlé or Hutchison to an Affiliate. Any attempted assignment or delegation in violation of this Section 6.6 will be void.
6.7. No Benefit to Others . 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 in any other Persons except as otherwise expressly provided in this Agreement. A Person who is not a Party will have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the terms of this Agreement.
6.8. Counterparts . This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which taken together will be deemed to constitute
one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission will be as effective as an original executed signature page.
6.9. Severability . To the fullest extent permitted by Applicable Laws, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and will not form part of this Agreement. To the fullest extent permitted by Applicable Laws and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement will remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Laws and achieves, as nearly as possible, the original intention of the Parties.
6.10. Further Assurance . Each Party will perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
6.11. 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 in the event of any conflict in the interpretation between the English version and such translation, the English version will prevail. English will be the official language of this Agreement and all communications between the Parties will be conducted in that language.
6.12. Construction . Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word or has the inclusive meaning represented by the phrase and/or. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Schedules, Exhibits and Appendices or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms including, include(s), such as, and for example as used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by without limitation.
[Signature Page Follows]
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this Agreement as a deed and intend to and hereby deliver this deed on the date first written above.
SEALED with the COMMON SEAL of Nutrition Science Partners Limited And SIGNED by Christian Hogg its Director in the presence of
EXHIBIT A TO OPTION AGREEMENT
LICENSE AGREEMENT
by and between
NUTRITION SCIENCE PARTNERS LIMITED
and
NESTLÉ HEALTH SCIENCE S.A.
[DATE]
Article I DEFINITIONS |
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Article II GRANT OF RIGHTS |
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Article III DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION |
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Article IV ROYALTIES AND PAYMENTS |
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Article V COVENANTS |
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Article VI REPRESENTATIONS AND WARRANTIES |
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Article VII INTELLECTUAL PROPERTY |
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Article VIII TERM AND TERMINATION |
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Article IX PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE |
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Article X MISCELLANEOUS |
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Schedules and Appendices |
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Schedule 1.13 |
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Company Patent Rights |
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Schedule 1.18 |
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[**] Milestone Criteria |
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Schedule 1.27 |
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First Regulatory Approval for [**] |
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Schedule 1.28 |
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First Regulatory Approval for [**] |
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Schedule 1.33 |
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HMPL-004 |
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Schedule 1.45 |
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Key Patent Rights |
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Schedule 6.2 |
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Disclosures |
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Appendix A |
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Independent Expert Appointment Procedure |
LICENSE AGREEMENT
This LICENSE AGREEMENT (the Agreement ) is entered into as a deed on this [DATE] (the Execution Date ), by and among Nutrition Science Partners Limited, a limited company organized and existing under the laws of Hong Kong with its principal offices at 22nd Floor, Hutchison House, 10 Harcourt Road, Hong Kong (the Company ) and Nestlé Health Science S.A., a company organized and existing under the laws of Switzerland with its principal offices at Rue des Remparts 2, 1095 Lutry, Switzerland ( Nestlé ). Nestlé and the Company are hereinafter referred to collectively as the Parties and individually as a Party .
RECITALS
WHEREAS, pursuant to the Joint Venture Agreement dated as of [ · ] November 2012 (as such may be amended from time to time in accordance with its terms, the Joint Venture Agreement ), Hutchison MediPharma (Hong Kong) Limited, a limited company organized and existing under the laws of Hong Kong ( Hutchison ), Hutchison China MediTech Limited, a company organized and existing under the laws of the Cayman Islands, the Company and Nestlé agreed to form the Company, a joint venture, in part for the purpose of the discovery, development, registration, manufacture and commercialization of Products in the Field;
WHEREAS, in connection with such joint venture, the Company granted to Nestlé, inter alia, pursuant to an Option Agreement dated as of [DATE] (as such may be amended from time to time in accordance with its terms, the Option Agreement ), an exclusive option to obtain an exclusive royalty-bearing license to Commercialize HMPL-004 and any Products in the Field in the Territory; and
WHEREAS, Nestlé has exercised such option with respect to the US and Canada on the terms set forth therein and the Parties have obtained a clearance (where required) for this Agreement under the HartScottRodino Antitrust Improvements Act of 1976.
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE I
DEFINITIONS
The terms defined in this Article will have the meanings ascribed to them herein whenever they are used in the Agreement, unless otherwise clearly indicated by the context.
1.1. Affiliate(s) means, with respect to a Person, any Person that controls, is controlled by, or is under common control with such first Person. For purposes of this definition only, control means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or otherwise, or (b) to own, directly or indirectly, more than fifty per cent (50%) of the outstanding voting rights exercisable at a shareholder meeting (or
equivalent), or other ownership interests of such Person. Notwithstanding the foregoing, in no event will Nestlé be considered an Affiliate of the Company or will the Company be considered an Affiliate of Nestlé or any of its Affiliates.
1.2. Agreement will have the meaning set forth in the introduction to this Agreement.
1.3. Applicable Laws means all applicable laws, statutes, ordinances, regulations, rules, guidance, or orders of any kind whatsoever (including without limitation from any Regulatory Authority), including (without limitation) the FD&C Act, Prescription Drug Marketing Act, Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a et seq.), and Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.), the Hong Kong Companies Ordinance (Cap. 32 of the Laws of Hong Kong) and all counterparts thereto in other jurisdictions, all as amended from time to time.
1.4. Business Day means a day on which banks are open for normal banking business (excluding Saturday, Sunday and public holidays) in Hong Kong, Peoples Republic of China and Switzerland (Canton de Vaud).
1.5. Calendar Quarter means, with respect to a given Calendar Year, means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.6. Calendar Year means any calendar year, beginning on January 1 and ending on December 31.
1.7. Clinical Trial means a human clinical study conducted on sufficient numbers of human subjects that is designed to (i) establish that a pharmaceutical product, food supplement or a medical food product is reasonably safe for continued testing, (ii) investigate the safety and efficacy of the pharmaceutical product, food supplement or the medical food product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product, food supplement or the medical food product in the dosage range to be prescribed or (iii) support Regulatory Approval of such pharmaceutical product, food supplement or medical food product or label expansion or demonstration of benefit of such pharmaceutical product, food supplement or medical food product, all in accordance with Applicable Laws.
1.8. Combination Product will have the meaning set forth in Section 1.52 .
1.9. Commercialization means any and all activities of using, importing, exporting, marketing, promoting, distributing, offering for sale or selling a Product including pre-commercial launch market development activities conducted in anticipation of Regulatory Approval of a Product, seeking pricing and reimbursement approvals for a Product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority regarding Post-Approval Clinical Trials, all activities required to fulfill ongoing regulatory obligations, including adverse event reporting and
all activities relating to the licensing of a Product (including sourcing and negotiations with potential licensees). When used as a verb, Commercialize means to engage in Commercialization.
1.10. Commercially Reasonable Efforts means, with respect to a Party, those efforts and resources that such Party or its Affiliates would reasonably devote to a product or compound owned by it or to which it has rights of the type it has hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account the competitiveness of the global and local marketplace, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), the pricing and launching strategy for the respective product, the proprietary position of the product, the profitability and the relative potential safety and efficacy of the product and other relevant factors, including technical, legal, scientific, regulatory or medical factors, all as measured by the facts and circumstances at the time such efforts are due. Commercially Reasonable as used herein will be interpreted in a corresponding manner.
1.11. Company Indemnified Party has the meaning set forth in Section 9.2 .
1.12. Company Know-How means Information that is Controlled by the Company as of the Execution Date or after the Execution Date and until the end of the Term, that is necessary or useful for the use, Development or Commercialization of HMPL-004 or a Product including any Improvements, from time to time.
1.13. Company Patent Rights means any Patent Right that is Controlled by the Company as of the Execution Date or after the Execution Date and until the end of the Term, that is necessary or useful for the use, Development or Commercialization of HMPL-004 or a Product including any Improvements, from time to time. The Company Patent Rights existing as of the Execution Date are set forth on Schedule 1.13 and include the Key Patent Rights.
1.14. Company Portion has the meaning set forth in Section 4.3.3(a) .
1.15. Company Technology means the Company Know-How, Company Patent Rights, and all other Intellectual Property Rights in any of the foregoing.
1.16. Confidential Information means, with respect to a Party, all Information which is Controlled by such Party and is disclosed by such Party to another Party pursuant to this Agreement.
1.17. Control or Controlled means, with respect to any Intellectual Property Right, Information, documents or materials, the possession, ownership, the ability to use pursuant to a license or sublicense and the ability to license or sublicense to another person, of such Intellectual Property Right, Information, document or materials, by a Party or any of its Affiliates (other than pursuant to this Agreement, the Governing Agreements and/or any other license agreement between the Parties) as provided in this Agreement without violating an agreement with or other rights of any Third Party; it being understood and agreed that the term Control will not apply to any Intellectual Property right for which the licensing Party will be
required to make any payments to any Third Party in connection with the licenses granted under this Agreement unless, but only if and for such time that, the other Party agrees and does promptly pay to the licensing Party all such payments arising out of the grant of the license to the other Party (as so mutually agreed between the Parties in good faith).
1.18. [**] means [**].
1.19. Development means pre-clinical and clinical activities performed by or on behalf of the Company with respect to Products in an indication in the Field in a jurisdiction in the Territory for the purpose of obtaining and maintaining Regulatory Approval with respect to such indication in such jurisdiction and activities performed by or on behalf of the Company with respect to Products destined as medical food products. Development will include, without limitation, all activities related to discovery, research, pre-clinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs and statistical analysis with respect to Products. Notwithstanding anything to the contrary in this Agreement, Development will not include Manufacturing or Commercialization. When used as a verb, Develop means to engage in Development.
1.20. Disclosing Party has the meaning set forth in Section 5.1.1 .
1.21. Dispute has the meaning set forth in Section 10.1.2 .
1.22. Execution Date will have the meaning set forth in the introduction to this Agreement.
1.23. FDA means the US Food and Drug Administration.
1.24. Field means any and all uses, including without limitation, the treatment, prevention or diagnosis of gastrointestinal diseases, disorders or conditions in humans.
1.25. Financial Records has the meaning set forth in Section 4.4.5 .
1.26. First Commercial Sale means, with respect to any Product, the first arms length sale of such Product by Nestlé or its Affiliate or Sublicensee to a Third Party in a jurisdiction in the Territory after such Product has been granted Regulatory Approval by the appropriate Regulatory Authority(ies) for such jurisdiction.
1.27. First Regulatory Approval for [**] means the successful [**].
1.28. First Regulatory Approval for [**] means the successful [**].
1.29. Force Majeure has the meaning set forth in Section 10.2 .
1.30. Generic Product means, on a country-by-country basis and Product-by-Product basis, a product [**].
1.31. Governing Agreements means this Agreement, the Joint Venture Agreement, the Option Agreement, the Research and Development Collaboration Agreement and the Services Agreements.
1.32. Government Authority means any court, agency, department, authority, regulatory body or other instrumentality of any national, state, county, city or other government or political subdivision.
1.33. HMPL-004 means (i) the compound designated by Hutchison as HMPL-004 [**].
1.34. ICC means the International Chamber of Commerce.
1.35. Improvement means any improvement, enhancement, modification, addition or other change to any Company Technology to the extent necessary or useful for the use, Development or Commercialization of HMPL-004.
1.36. Nestlé Health Science S.A. has the meaning set forth in Section 9.3 .
1.37. Indemnified Party has the meaning set forth in Section 9.3 .
1.38. Indemnifying Party has the meaning set forth in Section 9.3 .
1.39. Independent Expert Appointment Procedure means the procedure set out in Appendix A for the appointment of an independent Third Party expert.
1.40. Information means any data, results, technology or information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical and clinical test data and data resulting from non-clinical studies), chemistry, manufacturing and controls information, stability data and other study data and procedures.
1.41. Infringement has the meaning set forth in Section 7.4.1 .
1.42. Intellectual Property means (i) any intellectual property or related proprietary rights in any jurisdiction, whether owned or held for use under license, whether registered or unregistered, including such rights in (a) all inventions, invention disclosures and improvements thereto (whether patentable or unpatentable and whether or not reduced to practice), all issued patents and pending patent applications, any divisions, continuations, continuations-in-part, reissues, continuing patent applications, reexaminations and extensions thereof and any counterparts claiming priority therefrom, and all utility models, design patents, patents of importation/confirmation, certificates of invention, certificates of registration and similar rights, (b) all trademarks, service marks, certification marks, trade dresses, logos, trade names and corporate names, including all goodwill associated therewith, and all applications, registrations and renewals in connection therewith, (c) all works of authorship (whether or not copyrightable), all copyrights, all moral rights and all applications, registrations and renewals in connection therewith, (d) all trade secrets and confidential business information and any rights to limit the
use or disclosure thereof by any Person (including ideas, research and development, know-how, formulas, compositions, manufacturing and production processes and techniques, technical data, designs, drawings, specifications, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals), and (e) internet domain names, (ii) all copies and tangible embodiments of any of the foregoing (in whatever form or medium) and (iii) any goodwill associated with the foregoing.
1.43. Intellectual Property Rights will mean any and all rights in relation to the Intellectual Property licensed pursuant to this Agreement or thereafter coming into existence, and all applications for, renewals of and extensions of the foregoing, regardless of whether or not such rights have been registered with the appropriate authorities in such jurisdictions in accordance with the Applicable Laws.
1.44. Joint Venture Agreement will have the meaning set forth in the recitals to this Agreement.
1.45. Key Patent Rights means Company Patent Rights set forth in Schedule 1.45 .
1.46. Liability has the meaning set forth in Section 9.1 .
1.47. License Agreement means this Agreement.
1.48. Manufacture , Manufactured or Manufacturing means all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and storage of Products to be Developed or Commercialized in the Territory, including active pharmaceutical ingredient manufacturing, whether such activities are conducted by the Company, its Affiliates or a Third Party contractor of such Party (under a contract manufacturing or tolling arrangement). Notwithstanding the foregoing, Manufacturing will not mean Developing or Commercializing. When used as a verb, Manufacture means to engage in Manufacturing.
1.49. NDA means a New Drug Application or Biologics License Application, each as defined in the FD&C Act and the regulations promulgated thereunder.
1.50. Nestlé will have the meaning set forth in the introduction to this Agreement.
1.51. Nestlé Indemnified Party has the meaning set forth in Section 9.1 .
1.52. Net Sales means, on a country-by-country and Product-by-Product basis, the gross amounts invoiced by Nestlé, its Sublicensees or its Affiliates, as applicable, to Third Parties for sales of a Product in the Field in such country, less the following deductions to the extent included in the gross invoiced sales price for such Product or otherwise paid or incurred by Nestlé, its Sublicensees or its Affiliates with respect to the sale of such Product in such country:
(a) [**]
(b) [**]
(c) [**]
(d) [**]
(e) [**]
(f) [**].
[**].
Notwithstanding the foregoing, in the event a Product is sold as a combination product that includes the HMPL-004 and an active agent that is not HMPL-004 (such combination product, the Combination Product ), Net Sales will be calculated by multiplying the Net Sales of the Combination Product by the fraction A/(A+B), where A is the gross average invoice price of the Product during the relevant Calendar Quarter if sold separately in a country and B is the gross average invoice price of the other product(s) included in the Combination Product during the relevant Calendar Quarter if sold separately in such country. In the event no such separate sales are made by Nestlé, its Affiliates or Sublicensees in a country, Net Sales of the Combination Product will be calculated in a manner to be negotiated and agreed upon by the Parties, reasonably and in good faith, prior to any sale of such Combination Product, which will be based upon the respective cost of goods sold of the active components of such Combination Product.
1.53. New Third Party Licenses will have the meaning set forth in Section 4.3.3(a) .
1.54. Option Agreement has the meaning given in the recitals to this Agreement.
1.55. Party and Parties will have the meaning set forth in the introduction to this Agreement.
1.56. Party IP will have the meaning set forth in Section 2.3 .
1.57. Patent Right means any and all (i) national and international patent applications filed under Applicable Laws in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (ii) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, (iii) utility models, petty patents or similar rights or protections based on the patent or patent applications or on the priority applications on which the patent or patent applications are based and includes all divisional, continuations, continuations-in-part, renewals and reissues of such patents, patent applications, utility models, petty patents, and (iv) any other rights or protections similar to any of the foregoing.
1.58. Person means 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 or department or agency of a government.
1.59. Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.
1.60. Post-Approval Clinical Trial means any Clinical Trial for use of a Product in an indication, other than a Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication.
1.61. Product means any pharmaceutical product, food supplement or medical food product in finished form that contains HMPL-004, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.
1.62. Receiving Party has the meaning set forth in Section 5.1.1 .
1.63. Regulatory Approval means, with respect to a Product, the approval and authorization of a Product by a Regulatory Authority in a jurisdiction where such Product will be Manufactured or Commercialized, including, with respect to the Commercialization of such Product, pricing approval.
1.64. Regulatory Authority means any supranational, national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with jurisdiction in one or more of the countries of the Territory involved in the granting of Regulatory Approvals.
1.65. Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in one or more of the countries in the Territory, whether obtained before or after a Regulatory Approval in such countries. Regulatory Submissions include, without limitation, investigational new drug applications and new drug applications, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular jurisdiction.
1.66. Research and Development Collaboration Agreement means that Research and Development Collaboration Agreement entered into by 和 记 黄埔医 药 ( 上海 ) 有限公司 Hutchison MediPharma Limited, Nestlé Health Science S.A. and the Company dated as of [ · ].
1.67. Right of Reference means a Right of Reference as defined in 21 C.F.R. § 314.3(b) or any analogous Applicable Laws recognized outside of the US.
1.68. Rules has the meaning set forth in Section 10.1.3 .
1.69. Services Agreements means that Services Agreement entered into by 和 记 黄埔医 药 ( 上海 ) 有限公司 Hutchison MediPharma Limited and the Company dated as of [ · ] and the Services Agreement entered into by Nestlé and the Company dated as of [ · ].
1.70. Sublicense means an agreement or arrangement pursuant to which such a sublicense has been granted to a Sublicensee.
1.71. Sublicensee means an Affiliate or Third Party that is granted a license, sublicense or other grant of rights under the licenses granted pursuant to Article II of this Agreement.
1.72. Sublicensee Material Breach has the meaning set forth in Section 2.4.2 .
1.73. Sublicensor means a Party that has granted a Sublicense under rights granted to such Party under this Agreement.
1.74. Sued Party has the meaning set forth in Section 7.5.2 .
1.75. Term has the meaning set forth in Section 8.1 .
1.76. Territory will mean the US and Canada.
1.77. Third Party means any Person other than the Company and its Affiliates and Nestlé and its Affiliates.
1.78. Trademark means any trademark of the Company in connection with a Product in accordance with Section 7.3 .
1.79. US means the United States of America.
1.80. Withholding Taxes will have the meaning set forth in Section 4.4.2 .
ARTICLE II
GRANT OF RIGHTS
2.1. License to Nestlé. Subject to the terms and conditions of this Agreement, the Company hereby grants to Nestlé, effective on the Execution Date an exclusive (exclusive even as to the Company and its Affiliates) and, subject to Section 8.4 , irrevocable license, with the right to Sublicense as set forth in Section 2.4 , of the Company Technology, to use, have used, Commercialize and have Commercialized (but, subject to Section 3.3 , in no event Manufacture or have Manufactured) HMPL-004 and any Products in the Field in the Territory during the Term in accordance with the terms of this Agreement.
2.2. Improvements to Company Technology. The Company will from time to time promptly disclose to Nestlé and its Affiliates full details of any and all Improvements made by, or on behalf of, the Company or any of its Affiliates during the Term. Any such Improvements will be owned by the Company, and if subject to patent protection will form part of the Company Patent Rights or, if unpatented, will form part of the Company Know-How without any variation to the royalties payable by Nestlé under this Agreement.
2.3. Non Specific New Technology. Each Party will notify the other of any invention or discovery by such Party, its Affiliates, licensees or Sublicensees or Third Parties acting on their behalf, of any Intellectual Property, Patent Right or know-how (which is not an Improvement and does not form part of the Company Technology) of a general nature which is not specific to, but could reasonably be beneficial or helpful for the Commercialization of
HMPL-004 ( Party IP ). Following receipt of such notice, if requested by either Party, the Parties will discuss in good faith the terms on which such Party IP could be licensed to the other Party (whether pursuant to an amendment to this Agreement or otherwise). For the avoidance of doubt, neither Party will be required to enter into any license with respect to such Party IP. Nothing in this Section will oblige Nestlé to disclose any business confidential information unrelated to HMPL-004.
2.4. Sublicensing.
2.4.1. Nestlé Right to Sublicense .
(a) Nestlé may, on a country-by-country basis, grant Sublicenses to its Affiliates or to Third Parties of all or a portion of the rights granted to Nestlé under this Agreement by the Company; provided that Nestlé will (i) remain responsible for the performance of its Sublicensees under this Agreement and (ii) cause its Sublicensees to comply with the terms of this Agreement.
(b) Each Sublicense granted by Nestlé of all or a portion of the rights granted to Nestlé under this Agreement (i) will be subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (ii) will not diminish, reduce or eliminate any of Nestlés obligations under this Agreement; (iii) will require the Sublicensee(s) to comply with all applicable terms of this Agreement; (iv) will require that any Sublicensee grant to the Company a Right of Reference to the same extent of the Right of Reference granted to the Company pursuant to Section 2.5.2 ; and (v) will prohibit further sublicensing except on terms consistent with this Section 2.4.1 . Nestlé will provide the Company with a complete copy of each Sublicense granted to a Third Party within thirty (30) days after execution thereof; provided , however , that Nestlé may redact any Confidential Information from such Sublicense to the extent that such redactions do not reasonably impair the Companys ability to ensure compliance with this Agreement.
2.4.2. Breach of Sublicense . In the event of an uncured material breach by any Sublicensee which is an Affiliate of Nestlé under a Sublicense that would constitute a material breach of the Sublicensors obligations under this Agreement (a Sublicensee Material Breach ), the Sublicensor will provide prompt written notice of such Sublicensee Material Breach to the other Party and will use Commercially Reasonable Efforts to remedy such Sublicensee Material Breach; provided , however , that if the Sublicensor is unable to cure such Sublicensee Material Breach in accordance with Section 8.3.1 of this Agreement, such Sublicensee Material Breach will be deemed to be an uncured material breach by the Sublicensor under this Agreement.
2.4.3. Effect of Termination on Sublicenses . In the event of a termination of this Agreement pursuant to Article VIII while one or more Sublicense granted under Section 2.4 is in effect, any and all such Sublicenses will immediately terminate upon termination of this Agreement, other than Sublicenses with Third Parties, where the Sublicensee is not in material breach of the Sublicense, which will be novated by Nestlé to the Company, subject to consent of
such Third Party. The relevant Sublicensor will upon termination of this Agreement or as soon as possible thereafter, give written notice of such to the relevant Sublicensees.
2.5. Right of Reference.
2.5.1. Nestlé Right of Reference . The Company hereby grants, and will cause its Affiliates and Sublicensees to grant, to Nestlé, its Affiliates and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by the Company, its Affiliates and Sublicensees relating to HMPL-004 or a Product to the extent necessary to obtain Regulatory Approval of any Product in the Field in any country of the Territory, and the Company will provide a signed statement to this effect, if requested by Nestlé, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Applicable Law recognized outside of the US).
2.5.2. Company Right of Reference . Nestlé grants, and will cause its Affiliates and Sublicensees to grant, to the Company, its Affiliates and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by Nestlé, its Affiliates and Sublicensees relating specifically to HMPL-004 and the Products in the Territory (if any) to the extent necessary to obtain Regulatory Approval of any Product in the Field in any jurisdiction outside the Territory, and Nestlé will provide a signed statement to this effect, if requested by the Company, in accordance with 21 C.F.R. § 314.50(g)(3) (or any analogous Applicable Law recognized outside of the United States).
2.6. Transfer of Regulatory Materials. As soon as reasonably practicable after the grant of Regulatory Approval for a Product, the Company will take the actions reasonably necessary to transfer ownership and, as applicable, physical possession to Nestlé of all Regulatory Approvals, material Regulatory Submissions, correspondence and related information (including any investigational new drug applications, NDAs and other Regulatory Approvals) for HMPL-004 and such Product in the Territory and will notify the appropriate Regulatory Authorities of such transfer of ownership. All costs associated with such actions will be borne by the Company.
2.7. Delivery of Company Know-How. As soon as reasonably practicable after the Execution Date and in respect of any Improvement, as soon as reasonably practicable, after inclusion of such Improvement in the Company Technology, the Company will transfer to Nestlé true and complete copies of all Company Know-How (in electronic or hard copy format) with, where applicable (and within reason), a translation into English. Nestlé will not use the Company Know-How transferred to it in accordance with this Section 2.7 other than in accordance with the rights expressly granted to it under this Agreement. Except in connection with Sublicenses permitted and granted pursuant to this Article II , Nestlé will not sell or otherwise transfer any Company Know-How to any Third Party.
2.8. No Other Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights will be deemed granted to either Party by implication, estoppel or otherwise, with respect to any Intellectual Property rights. All rights not expressly granted by either Party to the other hereunder are reserved.
2.9. Licenses for Export.
2.9.1. This Agreement is made subject to any restrictions concerning the export of products or technical information which may be imposed upon or related to the Company or Nestlé from time to time. Each Party agrees that it will not export, directly or indirectly, any
technical information acquired from the other Party pursuant to this Agreement or any Product using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate Regulatory Authority.
2.9.2. The Company will be solely responsible for obtaining any governmental licenses or approvals required in the Peoples Republic of China or elsewhere for the export of the Company Technology or any Improvement and will immediately notify Nestlé if such required licenses or approvals are refused or revoked.
ARTICLE III
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION
3.1. Information Exchange.
3.1.1. Development and Commercialization . Nestlé will report to the Company on Commercialization activities undertaken by Nestlé, its Affiliates and Sublicensees with respect to HMPL-004 and the Products by providing a reasonably detailed summary of all results and data obtained from such activities (including Nestlés Commercially Reasonable Efforts to achieve the diligence obligations set forth in Section 3.2.2 ), together with a summary of activities that Nestlé, its Affiliates and Sublicensees intend to undertake during the next [**] months with respect to HMPL-004 and the Products and a summary of Commercialization activities that Nestlé, its Affiliates and Sublicensees have undertaken in the relevant Calendar Quarter and intend to undertake during the next [**] months with respect to the Products in the relevant jurisdictions within the Territory. Such reports will be provided in English by Nestlé to the Company at least once every Calendar Quarter and Nestlé will have the right to exclude or redact all business confidential information specifically relating to Nestlé.
3.2. Diligence Requirements.
3.2.1. Of the Company . The Company will use Commercially Reasonable Efforts to conduct all Development necessary to obtain all Regulatory Approvals for HMPL¬004 and/or Products in the jurisdictions within the Territory and maintain any Regulatory Approvals obtained by the Company for a Product for which the Company (or an Affiliate of the Company) has obtained Regulatory Approval in the Field in the jurisdictions within the Territory. The Company will perform, and will ensure that its Affiliates and Sublicensees perform, all activities required of it hereunder with respect to HMPL-004 and the Products, including the Development of HMPL-004 and such Products, in accordance with and pursuant to all Governing Agreements and any other applicable agreements entered into by, on the one hand, the Company, its Affiliates or Sublicensees, and, on the other hand, Nestlé, Hutchison and/or their respective Affiliates.
3.2.2. Of Nestlé . Nestlé will use Commercially Reasonable Efforts (i) to pay all applicable maintenance fees for Regulatory Approvals relating to Commercialization for HMPL-004 and the Products in such jurisdiction in the Territory for which Regulatory Approvals for HMPL-004 and the Products have been obtained (as the case may be) and (ii) for the US only,
Commercialize Products that have received Regulatory Approval for use in humans in the Field as soon as reasonably practicable. Nestlé will use all Commercially Reasonable Efforts to perform, and will ensure that its Affiliates and Sublicensees use all Commercially Reasonable Efforts to perform, all activities required of it hereunder with respect to HMPL-004 and the Products, including Commercialization of HMPL-004 and such Products in the US, in accordance with and pursuant to all Governing Agreements and any other applicable agreements entered into by, on one hand, Nestlé, its Affiliates or Sublicensees and, on the other hand, Hutchison, the Company and/or their respective Affiliates.
3.3. Right to Manufacture. As between Nestlé and the Company, the Company will retain all rights to Manufacture and have Manufactured HMPL-004 and the Products. Nestlé and the Company agree that the Company will be the sole source of clinical and commercial supplies of HMPL-004 and the Products to Nestlé, its Affiliates and Sublicensees, and that such supply arrangement be on [**] and be documented in a supply agreement with reasonable terms to be negotiated by the Parties in good faith at a later date. Where the Company and Nestlé have been unable to agree the terms of the manufacturing agreement within [**] Business Days of the commencement of negotiations, or the Company is unable or unwilling to Manufacture HMPL-004 or the Products, the grant of rights to Nestlé pursuant to Section 2.1 will automatically be deemed to include the right to Manufacture and have Manufactured HMPL-004 and the Products anywhere in the world solely for Commercialization in the Field in the Territory (in which case, Nestlé will have the right to source itself any raw material required for the Manufacture of HMPL-004 and the Products).
ARTICLE IV
ROYALTIES AND PAYMENTS
4.1. Clinical Development Milestone. Nestlé will, within [**] Business Days of the achievement of [**] by the Company, pay the Company [**]. In the event that the Company cannot reach a decision on whether the [**] has been achieved, the Company may elect for determination to be performed by an independent Third Party expert mutually appointed by the Parties in accordance with the Independent Expert Appointment Procedure. If such independent Third Party expert determines that the [**] has been achieved, such determination will be final and binding. The cost of such independent Third Party expert will be borne by the Company.
4.2. Regulatory Approval Milestones.
Nestlé will pay the Company the following milestone payments within [**] days of the achievement of the relevant milestone event as described below:
Milestone Event |
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Milestone Payment |
[**] |
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[**] |
[**] |
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[**] |
Provided, however that in the event:
(a) [**] of a Product does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.2 will be reduced by [**].
(b) [**] of a Product does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.2 will be reduced by [**].
(c) [**] of a Product does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.2 will be reduced by [**].
(d) [**] of a Product does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.2 will be reduced by [**].
Such deductions in clauses (a) through (d) not to be cumulatively applied.
4.3. Royalties.
4.3.1. Royalty Rates . In addition to the payments under Sections 4.1 and 4.2 , in consideration for the rights granted to Nestlé under this Agreement, Nestlé will pay the Company the marginal royalties set forth below in this Section 4.3.1 on the Net Sales of the Products during each Calendar Year in the US and Canada, as such may be adjusted pursuant to the terms hereof.
|
Net Sales |
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[**] |
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[**] |
[**] |
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[**] |
[**] |
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[**] |
[**] |
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[**] |
[**] |
|
[**] |
4.3.2. Royalty Reduction . On a country-by-country basis where, at the time of sale of a Product, (a) the Key Patent Rights that cover such Product in such country are not validly registered patents or have been rejected, challenged, opposed, cancelled or otherwise rendered ineffective ( Invalid Claim ) or (b) there is a Generic Product being sold to patients for therapeutic use in such country, any royalty otherwise payable to the Company by Nestlé under Section 4.3.1 of this Agreement with respect to Net Sales of the relevant Product in such country will be reduced by [**]. On a country-by-country basis where, at the time of sale of a Product, there is (a) an Invalid Claim or a Generic Product being sold to patients for therapeutic use in such country without infringing the Key Patent Rights and (b) a Generic Product being sold to patients for therapeutic use in such country, any royalty otherwise payable to the Company by Nestlé under Section 4.3.1 of this Agreement with respect to Net Sales of the relevant Product in such country will be reduced to [**].
4.3.3. Royalty Reduction due to License of Third Party Intellectual Property .
(a) If, during the Term and after consultation with the Company, Nestlé and/or any of its Affiliates enters into an agreement with a Third Party in order to obtain a royalty bearing license under any Patent Right of a Third Party that, in Nestlés reasonable judgment, would be necessary for Nestlé to Manufacture (to the extent permitted hereunder) or Commercialize HMPL-004 or such Product in the Field in the Territory, which Nestlé may only do in compliance with Section 4.3.3(b) (a New Third Party License ), then Nestlé will be entitled, on a Product-by-Product and country-by-country basis, to credit against any royalty payable to the Company under Section 4.3.1 [**] of any royalty (but no other payments) (the Company Portion ) actually paid by or on behalf of Nestlé and/or any of its Affiliates to such Third Party as a result; provided, however, that in no event will any royalty payable to the Company be reduced as a result of this Section 4.3.3 by more than [**] of the amount otherwise due to the Company over the same period. In addition, any such Company Portion will not reduce the amounts due to the Company under Section 4.3.1 in any Calendar Quarter by more than [**] of the amounts otherwise due. Any deductions of a Company Portion to which Nestlé is entitled under this Section 4.3.3 will be carried forward to the next Calendar Quarter until fully exhausted.
(b) Sublicensing of New Third Party Licenses. All New Third Party Licenses will be sublicensable to the Company so that the Company receives a grant to the Intellectual Property licensed under such New Third Party License for purposes of the Company conducting activities or potential activities permitted under this Agreement or another Governing Agreement and for performing obligations under this Agreement or another Governing Agreement.
4.4. Reports and Payments.
4.4.1. Royalty Reports . Within [**] days after the end of each Calendar Quarter beginning with the Calendar Quarter in which the First Commercial Sale of a Product is made in any jurisdiction in the Territory, Nestlé will deliver to the Company a report setting forth for the previous Calendar Quarter the following information on a Product-by-Product basis: (a) the Net Sales of each Product in each jurisdiction, (b) the number of units sold by Nestlé, its Affiliates or Sublicensees, (c) the basis for any adjustments to the royalty payable for the sale of each Product, (d) the royalty due hereunder for the sales of each Product, and (e) the applicable exchange rate as determined in accordance with this Agreement. The total royalty due for the sale of Products during such Calendar Quarter will be remitted at the time such report is made.
4.4.2. Taxes and Withholding .
(a) [**].
(b) [**].
(c) [**].
(d) [**].
(e) [**].
4.4.3. Currency . All amounts payable and calculations hereunder will be in US dollars. As applicable, Net Sales and any royalty deductions will be translated into US dollars in accordance with Nestlés customary and usual currency conversion procedures, consistently applied. If, due to restrictions or prohibitions imposed by national or international authority, payments cannot be made as provided in this Article IV , the Parties will consult with a view to finding a prompt and acceptable solution, and Nestlé will deal with such monies as the Company may lawfully direct at no additional out-of-pocket expense to Nestlé.
4.4.4. Method of Payment . Except as permitted pursuant to Section 4.4.3 , each payment hereunder will be made by electronic transfer in immediately available funds via a bank wire transfer, an automated clearing house (ACH) mechanism or any other means of electronic funds transfer, at Nestlés election, to the bank account designed by the Company in accordance with this Section 4.4 in writing to Nestlé at least [**] days before the payment is due.
4.4.5. Record Keeping . Nestlé will keep, and will cause its Affiliates and Sublicensees to keep, books and accounts of record in connection with the sale of Products, including records of gross invoiced sales, Net Sales, exchange rates and royalty payments (collectively, the Financial Records ), in accordance with the International Financial Reporting Standards in force from time to time (as appropriate) and in sufficient detail to permit accurate determination of all figures necessary for verification of royalties and other payments to be made by Nestlé under this Article IV . Nestlé and its Affiliates and Sublicensees will maintain such records for a period of at least three (3) years after the end of the Calendar Quarter in which they are generated.
4.4.6. Audits . Upon thirty (30) days prior written notice from the Company, Nestlé will permit, and will cause its Affiliates and Sublicensees to permit, an independent certified public accounting firm of internationally recognized standing selected by the Company and reasonably acceptable to Nestlé, to examine, at the Companys sole expense, the relevant Financial Records of Nestlé and its Affiliates and Sublicensees as may be reasonably necessary to verify the amounts reported by Nestlé in accordance with Section 4.4.1 and the royalties and other payments made by Nestlé in accordance with this Article IV . The Company will be entitled to conduct an audit in accordance with this Section 4.4.6 not more than once in any Calendar Year and not more than once in respect of the Financial Records from any Calendar Year and such audit will be limited to the pertinent Financial Records from any Calendar Year ending not more than three (3) years prior to the date of the request. The accounting firm will be provided access to such Financial Records at Nestlés facility(ies) where such Financial Records are normally kept and such audit will be conducted during Nestlés normal business hours. Upon completion of the audit, the accounting firm will provide both Parties with a written report disclosing any discrepancies in the reports submitted by Nestlé or payments made by Nestlé, if any, and in each case, the specific details concerning any discrepancies. Any information provided by Nestlé to the accounting firm and the written report of the accounting firm will be the Confidential Information of Nestlé.
4.4.7. Underpayments/Overpayments . If a report of an independent public accounting firm submitted to the Parties in accordance with Section 4.4.6 shows any underpayment of royalties and other payments due under this Article IV , Nestlé will remit to the Company within forty five (45) days after receipt of such report by Nestlé, (a) the amount of such underpayment plus interest, calculated from the date such underpayment should have been originally made to the Company and (b) if such underpayment exceeds [**] of the total amount owed to the Company for the Calendar Year then being audited, the reasonable fees and expenses of such independent public accounting firm performing the audit, subject to reasonable substantiation thereof. If such independent public accounting firms written report shows any overpayment of royalties or other payments due under this Article IV , Nestlé will receive a credit equal to such overpayment plus interest, calculated from the date such overpayment was originally made to the Company hereunder against the royalties and other payments due under this Article IV otherwise payable to the Company.
4.4.8. Interest . Any payment under this Article IV that is more than [**] days past due or any credit under this Article IV will be subject to interest at an annual percentage rate of the twelve (12) month London Interbank Offered Rate plus [**] basis points if a Party does not make payment within [**] days of its receipt of notice that such amount is past due. Notwithstanding the preceding, if a Party contests any amounts due hereunder in good faith and promptly notifies the other Party of such dispute, interest will not accrue as to amounts being so contested until [**] days following the presentation of such notice to the other Party.
ARTICLE V
COVENANTS
5.1. Confidentiality.
5.1.1. Confidential Information . Each Party (the Receiving Party ) agrees to keep in strict confidence all Confidential Information that the other Party (the Disclosing Party ) provides, communicates or otherwise makes available to the Receiving Party and to protect the Confidential Information with the same degree of care normally used to protect its own Confidential Information of a similar nature. The Receiving Party will not disclose or allow disclosure of any Confidential Information to any Third Party and will not use any Confidential Information in any manner, except, in each case, for the purposes of implementing and enforcing this Agreement without the prior written consent of the Disclosing Party.
5.1.2. Exceptions to Confidentiality . The restrictions and obligations set forth in Sections 5.1.1 , 5.1.3 and 5.1.4 will not apply to any Confidential Information:
(a) which is or becomes generally available to the public through no fault on the part of the Receiving Party;
(b) which is lawfully in the possession of the Receiving Party (other than pursuant to the terms of this Agreement) without restriction as to its disclosure, prior to the disclosure of such information by or on behalf of the Disclosing Party or the Company, as reasonably evidenced by appropriate documentation;
(c) which lawfully becomes available to the Receiving Party from a source other than the Disclosing Party and the Company without any duty as to confidentiality or non-use;
(d) which is independently developed or otherwise created by the Receiving Party (other than pursuant to the terms of this Agreement) without the use of any Confidential Information of the Disclosing Party, as reasonably evidenced by appropriate documentation; or
(e) which is required to be disclosed or provided to any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) (i) pursuant to any Applicable Laws, judgment, decree or order; (ii) as necessary to make regulatory filings and communications related to HMPL-004 or any Products; or (iii) for the purpose of asserting or defending against any claims relating to Intellectual Property Rights, including, in particular, any action taken to protect and enforce Intellectual Property Rights; provided , however , that (x) any such information disclosed pursuant to this Section 5.1.2(e) will be disclosed only to the extent required by Applicable Laws, judgment, decree or order; (y) except with respect to required disclosure to tax authorities, the Party seeking to disclose or provide such information will give the other Parties prompt written notice of such requirement and fully cooperate with the other Parties so that the other Parties and/or the Company (as the case may be) may obtain reasonable assurances that confidential treatment will be accorded to such information; and (z) without limiting the generality of the foregoing, the Parties will use Commercially Reasonable Efforts to ensure that, subject to Applicable Laws, the list of the Products is redacted from any copy of this Agreement required to be filed with any government or regulatory body.
5.1.3. Measures to Keep Confidentiality . Each Party agrees that, prior to giving access to any Confidential Information to any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, advisors, consultants and agents, it will require each such Person to agree to be bound by all obligations of confidentiality and non-use under this Section 5.1 , and will take all reasonable steps and measures to ensure that each such Person will enter into a confidentiality undertaking to comply with and perform such obligations, in each case to the same extent as if they were direct parties to this Agreement.
5.1.4. Survival of Obligations . The obligations undertaken by the Parties under this Section 5.1 will survive the termination of this Agreement for any reason and will remain in effect and be binding on the Parties for a period of ten (10) years after the termination of this Agreement; provided that to the extent any Confidential Information constitutes a trade secret, as defined in the U.S. Uniform Trade Secrets Act or any Applicable Laws, then the Receiving Party will keep such trade secret confidential until such time as the Confidential Information no longer qualifies as a trade secret under Applicable Laws.
5.1.5. Notification . The Receiving Party will notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Partys discovery of any loss or compromise of the Disclosing Partys Confidential Information.
5.1.6. Destruction of Confidential Information . Upon the expiration or earlier termination of this Agreement, except with respect to Confidential Information necessary or useful for a Receiving Party to exercise any rights or perform any obligations under this Agreement surviving such expiration or termination, the Receiving Party will (a) destroy all tangible embodiments of Confidential Information of the Disclosing Party, including any and all
copies thereof, and those portions of any documents, memoranda, notes, studies and analyses prepared by the Receiving Party or its Affiliates that contain, incorporate or are derived from such Confidential Information and provide written certification of such destruction to the Disclosing Party in a form reasonably acceptable to the Disclosing Party, provided that the legal department of the Receiving Party will have the right to retain one (1) copy of any such tangible embodiments for archival purposes, provided such copy will continue to be maintained on a confidential basis subject to the terms of this Agreement, and (b) immediately cease, and will cause its Affiliates to cease, use of such Confidential Information as well as any information or materials that contain, incorporate or are derived from such Confidential Information.
5.1.7. Use of Name and Disclosure of Terms . Each Party will keep the existence of, the terms of and the transactions covered by this Agreement confidential and will not disclose such information to any Third Party through a press release or otherwise, or mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in any manner without the prior written consent of the other Party in each instance (which will not be unreasonably withheld). The restrictions imposed by this Section 5.1.7 will not prohibit either Party from making any disclosure that is required by Applicable Laws or the requirements of a national securities exchange or another similar regulatory body, including disclosing such information in any clinical trial database maintained by or on behalf of a Party, or that is expressly permitted under this Agreement. Further, the restrictions imposed on each Party under this Section 5.1.7 are not intended, and will not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to this Section 5.1.7 .
5.1.8. Remedies . The Parties acknowledge and agree that the restrictions set forth in Article V are reasonable and necessary to protect the legitimate interests of the Parties and that neither Party would have entered into this Agreement in the absence of such restrictions, and that any breach or threatened breach of any provision of Article V will result in irreparable injury to the other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of Article V by a Party, the other Party will be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights will be cumulative and in addition to any other rights or remedies to which such Party may be entitled in law or equity. The breaching Party agrees to waive any requirement that the non-breaching Party (a) post a bond or other security as a condition for obtaining any such relief and (b) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this S ection 5.1.8 is intended, or will be construed, to limit the Parties rights to equitable relief or any other remedy for a breach of any provision of this Agreement.
5.2. Compliance with Law.
5.2.1. General . Nestlé hereby covenants and agrees to comply with, and will cause its Affiliates to comply with, Applicable Laws related to the use and Commercialization of HMPL-004 and the Products. The Company hereby covenants and agrees to comply with, and will cause its Affiliates to comply with, Applicable Laws related to the use, Development and Manufacture of HMPL-004 and the Products. For the avoidance of doubt, nothing in this Agreement will require either Party to undertake any activity which violates, or which it believes, in good faith, may violate, any Applicable Laws.
5.2.2. Patient Information . Without limiting the generality of the foregoing, each Party agrees to abide, and will cause its Affiliates to abide, by all Applicable Laws concerning the
confidentiality or protection of patient identifiable information or patients protected health information in the course of their performance under this Agreement.
5.2.3. Debarment . Each Party agrees that it will not knowingly use, and will cause its Affiliates to not knowingly use, in any capacity, in connection with any of its obligations to be performed under this Agreement any individual who has been disqualified or debarred by the US Food and Drug Administration, pursuant to 21 U.S.C. §§ 335(a) or (b), or been charged with or convicted under US law for conduct relating to the development or approval, or otherwise relating to the regulation of the Product under the Generic Drug Enforcement Act of 1992, or any other relevant law, rule, or regulation applying in any jurisdiction in the Territory or has been disbarred, disqualified, or convicted under or for any equivalent or similar applicable foreign law, rule, or regulation applying in any jurisdiction in the Territory.
5.3. Anti-Corruption Laws.
5.3.1. Compliance with Anti-Corruption Law . In carrying out their responsibilities under this Agreement, the Parties will comply with all applicable anti-corruption laws in the countries where the Parties have their principal or other places of business and where they conduct activities under this Agreement. Additionally, the Parties understand and agree to comply with the US Foreign Corrupt Practices Act of 1977 ( US Act ) and the UK Bribery Act of 2010 ( UK Act ), in each case as revised, which in the case of the US Act generally prohibits the promise, payment or giving of anything of value either directly or indirectly to any government official for the purpose of obtaining or retaining business or any improper advantage, and in the case of the UK Act includes the prohibition on the making of any bribe to a foreign public official with the intention of influencing such person in order to obtain or retain business or an advantage in the conduct of business. For purposes of this Section 5.3.1 , (a) government official means any official, officer, representative, or employee of, including any doctor employed by, any non-US government department, agency or instrumentality (including any government-owned or controlled commercial enterprise), or any official of a public international organization or political party or candidate for political office; and (b) foreign public official means an individual who holds a legislative, administrative or judicial position of any kind, whether appointed or elected, of a jurisdiction or territory outside the United Kingdom (or any subdivision of such a jurisdiction or territory); exercises a public function (i) for or on behalf of a jurisdiction or territory outside the United Kingdom (or any subdivision of such a jurisdiction or territory), or (ii) for any public agency or public enterprise of that jurisdiction or territory (or subdivision); or is an official or agent of a public international organization.
5.3.2. Certain Covenants regarding Anti-Corruption . Additionally, each Party undertakes that neither it nor any of its, directors, employees, agents, consultants (or any other person who may be associated with a Party for the purposes of the UK Act) will directly or indirectly pay or give or promise to pay or give anything of value to any government official or a foreign public official for purposes of (a) influencing any act or decision of any such person in his official capacity; (b) inducing such person to do or omit to do any act in violation of the lawful duty of such official; (c) securing any improper advantage; or (d) inducing such person to use his position to affect or influence any act or decision of government or any legislative, administrative, public agency or other public body with respect to any activities undertaken relating to this Agreement. Additionally, the Parties will make reasonable efforts to comply with requests for information, including answering questionnaires and narrowly tailored audit inquiries, to enable the other Party to ensure compliance with any applicable anti-corruption laws.
5.3.3. Breach of Anti-Corruption Covenants . The Parties agree that a breach of the anti-corruption commitments in Section 5.3 will be considered a material breach of this Agreement and
that either Party may immediately seek all remedies available under law and equity including termination of this Agreement pursuant to Section 8.3.1 if it believes, in good faith, that the covenants under the anti-corruption commitments in this Section 5.3 have been breached by the other Party, without owing to the other any damages or indemnification resulting solely from such termination.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1. Representations and Warranties of Each Party. As of the Execution Date, each of Nestlé and the Company hereby represents and warrants to the other Party hereto as follows:
6.1.1. it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or formation;
6.1.2. the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval;
6.1.3. it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;
6.1.4. the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;
6.1.5. it is not subject to, and the execution, delivery and performance by it of this Agreement will not subject it to, bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors rights generally and equitable principles of general application; and
6.1.6. it has the full right, power and authority to grant all of the right, title and interest in the licenses granted to the other Party under this Agreement.
6.2. Additional Representations and Warranties of the Company. Except as set forth in Schedule 6.2, the Company hereby represents and warrants to Nestlé that as of the Execution Date:
6.2.1. the Company, together with its Affiliates, is the sole and exclusive owner of, and has the sole right, title and interest in and to, Company Patent Rights and Company Know-How, in each case free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien, lease, sublease, option, or charge of any kind, limitations on transfer or any subordination arrangement in favor of a Third Party;
6.2.2. the Company Technology comprises all of the Intellectual Property rights forming HMPL-004 and all of the Intellectual Property rights used by the Company, its Affiliates,
consultants and contractors in the Development and Commercialization of HMPL¬004 or any Products prior to the Execution Date;
6.2.3. all of the Company Patent Rights listed on Schedule 1.13 and the Key Patent Rights are in force or pending and have not been abandoned as of the Execution Date, and to the Companys knowledge, all such Company Patent Rights are valid and enforceable without any claims, challenges, oppositions, interference or other proceedings pending or threatened and the Company has filed and prosecuted patent applications within the Company Patent Rights in good faith and complied with all duties of disclosure with respect thereto and the Company has not initiated or been involved in any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any Company Technology, nor have any such proceedings been threatened by the Company, nor does the Company know of any valid basis for any such proceedings;
6.2.4. the Company has the right to use and disclose and to enable Nestlé to use and disclose (in each case under appropriate conditions of confidentiality) the Company Know-How free from encumbrances;
6.2.5. to the knowledge of the Company, the Development, Manufacturing and Commercialization of HMPL-004 and/or any Products in the Field in the Territory, in the form in which it is being Developed as of the Execution Date, does not infringe or misappropriate any Intellectual Property rights including the Patent Rights of a Third Party;
6.2.6. no Third Party has challenged or has threatened in writing to challenge the extent, validity or enforceability of the patents encompassed within the Company Technology relating to HMPL-004 or any Product (including, by way of example, through the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the US Patent and Trademark Office or any analogous entity of any jurisdiction in the Territory), and all application, registration, maintenance and renewal fees in respect of Company Patent Rights have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Company Patent Rights have been filed;
6.2.7. there are no claims, judgments or settlements pending against the Company or its Affiliates with respect to any Company Technology, and the Company has not received notice that any such claims, judgments or settlements are threatened or of any infringement or misappropriation by the Company of the Intellectual Property rights including Patent Rights of a Third Party;
6.2.8. the Company has not granted any Third Party, including any academic organization or agency, any rights to the Company Technology, HMPL-004 or the Products, or any other rights that would otherwise interfere or be inconsistent with Nestlés rights hereunder, and there are no agreements or arrangements to which the Company or any of its Affiliates is a party relating to the Products, HMPL-004, the Company Patent Rights, or the Company Know-How that would limit the rights granted to Nestlé under this Agreement or that restrict or will result in a restriction on Nestlés ability to register, use or Commercialize HMPL-004 or the Products in the Territory;
6.2.9. no officer or employee of the Company is subject to any agreement with any other Third Party which requires such officer or employee to assign any interest in any Company Technology relating to HMPL-004 or any Products to any Third Party;
6.2.10. all of the Companys employees, officers, and consultants have executed agreements or have existing obligations under Applicable Laws requiring assignment to the Company of all inventions made during the course of and as the result of their association with the Company and obligating the individual to maintain as confidential the Companys Confidential Information as well as Confidential Information of other parties (including Nestlé and its Affiliates) which such individual may receive, to the extent required to support the Companys obligations under this Agreement and all inventions relevant to the rights granted to Nestlé under this Agreement have been duly transferred to the Company or its Affiliates in accordance with such agreements or existing obligations and Applicable Laws or the Company has entered into binding agreements permitting such a transfer;
6.2.11. the Company has taken all reasonable precautions to preserve the confidentiality of the Company Know-How and has not committed any act, or omitted to commit any act, that may cause the Company Patent Rights to expire prematurely or be declared invalid or unenforceable;
6.2.12. the Company has not entered into a government funding relationship that would result in rights to HMPL-004 or any Product residing in the US Government, National Institutes of Health, National Institute for Drug Abuse or other agency, and the licenses granted hereunder are not subject to overriding obligations to the US Government as set forth in Public Law 96-517 (35 U.S.C. 200-204), as amended, or any similar obligations under the laws of any other country;
6.2.13. neither the Company nor any employee, agent or subcontractor of the Company involved in the Development of HMPL-004 or the Products has been debarred under subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); and
6.2.14. the Company is in compliance, and has at all times complied with, all Applicable Laws relating to the Company Technology, including Applicable Laws relating to export restrictions and controls and biodiversity (including the 1992 United Nations Convention on Biological Diversity and the 2011 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization).
6.3. Repeating Representations and Warranties of the Company. As and when any Improvements are included in the Company Technology, the Company hereby represents and warrants to Nestlé that as at such date the warranties set out in Section 6.2 are true and accurate in respect of any such Improvements.
6.4. Separate and Independent Representations and Warranties. Each of the warranties and representations in Sections 6.1 and 6.2 will be separate and independent and (unless expressly provided otherwise) will not be limited by reference to any other warranty or by anything in this Agreement.
6.5. Representation by Legal Counsel. Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will exist or be implied against the Party which drafted such terms and provisions.
6.6. No Inconsistent Agreements. Neither Party has in effect, and after the Execution Date, neither Party will enter into, any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement or limit the ability of either Party to grant the licenses set forth in Article II of this Agreement.
6.7. Disclaimer. The foregoing warranties of each Party are in lieu of any other warranties, express or implied, including any implied warranties of non-infringement, any implied warranties of merchantability or any implied warranties of fitness for a particular purpose all of which are hereby specifically excluded and disclaimed. Each Party hereby disclaims any representation or warranty that the Development or Commercialization of HMPL-004 or any Product under this Agreement will be successful.
6.8. Covenants.
6.8.1. The Company covenants and agrees that for the Term in the Territory:
(a) it will not grant any interest or rights in the Company Technology, nor will the Company assign or encumber its right, title or interest in or to the Company Technology to any Third Party, in each case in a manner inconsistent with the rights granted to Nestlé under this Agreement, and will use all reasonable precautions to preserve the confidentiality of the Company Technology;
(b) it will not amend or modify the terms of any agreement under which it obtains rights to any of the Company Technology in a manner that may affect Nestlés rights under this Agreement without the prior written consent of Nestlé;
(c) the Company 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 Company Technology, 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; provided that the Company and its Affiliates will not be restricted pursuant to this Section 6.8.1(c) to the extent an act or failure to act does not affect Nestlés rights under this Agreement; and
(d) if, at any time after the execution of this Agreement, it becomes aware that it or any employee, agent or subcontractor of the Company 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 three (3) FDA Clinical Investigator Restriction Lists, it will provide written notice of this to Nestlé within two (2) Business Days of it becoming aware of this fact.
6.8.2. Each Party covenants that (i) neither such Party nor, to the actual knowledge of such Party, any employee, agent or subcontractor of such Party to be involved in the Development of the Company Technology or the Products, has been debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); (ii) no Person who is known by such Party to have been debarred under Subsection (a) or (b) of Section 306 of said Act will be employed by such Party in the performance of any activities hereunder; and (iii) to the actual knowledge of such Party, no Person on any of the FDA clinical investigator enforcement lists (including, but not limited to, the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List) will participate in the performance of any activities hereunder.
ARTICLE VII
INTELLECTUAL PROPERTY
7.1. Ownership.
7.1.1. Ownership of Technology . Subject to the license grants under Article II of this Agreement, as between the Parties, the Company will own all Company Technology. Neither Party will take any action that would limit the other Partys right to exercise its rights under Section 2.4 . In the event inventorship and ownership of any Information or Patent Rights cannot be resolved by the Parties with advice of their respective Intellectual Property counsel, such dispute will be resolved through the dispute resolution mechanism set forth in Section 10.1 . For the avoidance of doubt, all Patent Rights, Information or other Intellectual Property Rights made or conceived during the Term solely by Nestlé (or its Affiliate) which is funded by Nestlé (or its Affiliate) will belong exclusively to Nestlé.
7.1.2. Employee Assignment . To the extent permissible under Applicable Laws, each Party will cause each employee and contractor conducting work on such Partys behalf under this Agreement to sign a contract that (a) compels prompt disclosure to the Party of all Company Technology, as applicable, conceived or reduced to practice by such employee or contractor during any performance under this Agreement, (b) automatically assigns to the Party all right, title and interest in and to all such Company Technology and all Patent Rights disclosing or claiming such Company Technology and (c) obligates such persons to similar obligations of confidentiality as set forth in this Agreement. Each Party will require each employee and contractor conducting work on such Partys behalf under this Agreement to maintain records in sufficient detail and in a good scientific manner appropriate for patent purposes to properly reflect all work done. Each Party will be responsible for the payment of any remuneration due to employees under any Applicable Laws that provides compensation to such employee inventors.
7.2. Filing, Prosecution and Maintenance of Patent Rights.
7.2.1. Company Patent Rights . The Company will be responsible, at its sole cost and expense, for the preparation, filing and prosecution, maintenance and defense of the Company Patent Rights in the Territory. The Company will keep Nestlé advised on the status of preparation, filing, prosecution, maintenance and defense of all patent applications included within Company Patent Rights and the maintenance of any issued patents within Company
Patent Rights. Further, the Company will consult and reasonably cooperate with Nestlé with respect to the preparation, filing, prosecution, maintenance and defense of all Company Patent Rights, including: (a) allowing Nestlé a reasonable opportunity and reasonable time to review and comment regarding relevant material communications and drafts of any material responses or proposed filings by Nestlé before any applicable filings are submitted to any relevant patent office or Government Authority and (b) reflecting any reasonable comments offered by Nestlé in any final filings submitted by the Company to any relevant patent office or Government Authority.
7.2.2. Step-In Rights . If the Company does not file, prosecute or maintain any Patent Right as required by Section 7.2.1 , Nestlé may, if it is reasonable to do so to protect its interests, step-in and carry out such activity itself upon delivery of a notice to such effect to the Company. Upon delivery of such notice, Nestlé will have the right to file, prosecute and maintain such Patent Right at the Companys expense, and the Company will perform such acts as may be reasonably necessary for Nestlé to file, prosecute or maintain such Patent Right, at the Companys sole cost and expense. For the avoidance of doubt, any exercise by Nestlé of the right conferred by this Section 7.2.2 will be without prejudice to any rights or remedies available to Nestlé whether under this Agreement or otherwise.
7.2.3. Patent Term Extensions . The Parties will cooperate, if necessary and appropriate, with each other in gaining patent term extensions, including supplementary protection certificates and any other extensions that are available now or will become available in the future wherever applicable to Patent Rights that are applicable to HMPL-004 and/or the Products at the Companys cost. The Parties will, if necessary and appropriate, use reasonable efforts to agree upon a joint strategy relating to patent term extensions.
7.2.4. Orange Book Listing . Nestlé will, at the Companys expense and upon the Companys reasonable request, (a) provide all necessary or reasonably useful information to enable the Company to make filings with Regulatory Authorities with respect to Company Patent Rights as required by Regulatory Authorities in the Territory, and (b) will cooperate with the Company in connection therewith, including providing reasonable assistance for the Company in meeting any submission deadlines.
7.2.5. Costs and Expenses . Except as set forth in Section 7.2.2 , the Company will pay or reimburse Nestlé for all costs and expenses of filing, prosecuting, maintaining, defending and extending the Company Patent Rights.
7.3. Trademarks. The Company will select and own the Trademarks and all applications and registrations of Trademarks for the Products which have been Developed or for which the Company has obtained Regulatory Approval and will be solely responsible for applying for and maintaining the registrations for such Trademarks throughout the Territory, and all goodwill associated therewith will inure to the benefit of the Company. The Company will bear all costs of applying for and maintaining registrations for such Trademarks. The Company will assume full responsibility, at its sole cost and expense, for prosecuting any infringement of
any Company owned Trademark by a Third Party, and will be entitled to retain all recoveries in connection therewith.
7.4. Enforcement of Technology Rights.
7.4.1. Notice . Each Party will promptly notify the other in the event of any actual, potential or suspected infringement of a patent under the Company Patent Rights by any Third Party (an Infringement ).
7.4.2. Enforcement . If reasonably requested by Nestlé, the Company will institute litigation or take other steps to remedy an Infringement, and any such litigation or steps will be at the Companys reasonable expense. In order to establish standing, Nestlé, upon request of the Company, agrees to timely commence or to join in any such litigation, at the Companys reasonable expense, and in any event to cooperate with the Company in such litigation or steps at the Companys reasonable expense. Nestlé will have the right to consult with the Company about such litigation and to participate in and be represented by independent counsel in such litigation at Nestlés own expense, other than in respect of any reasonable fees incurred in respect of matters undertaken at the request of the Company where such fees will be at the Companys expense. If the Company fails to institute such litigation or otherwise take steps to remedy an Infringement of any Company Patent Right within [**] days of its receipt of notice thereof or if Nestlé elects to conduct such litigation itself, then Nestlé will (at its expense) have the right, but not the obligation, upon [**] days prior notice to the Company to institute any such litigation. Nestlé will have full control of such litigation or steps but will not, without the prior written consent of the Company, enter into any compromise or settlement relating to such litigation that (a) admits the invalidity or unenforceability of any Company Patent Right or (b) requires the Company to abandon any Company Patent Right. The Company will, at its own expense, cooperate with Nestlé in any such litigation. Any financial award granted in favor of Nestlé or the Company pursuant to an enforcement action under this Section 7.4.2 will be applied in priority to indemnify Nestlé (as licensee) for its losses and costs as a result of such decision and the excess will be shared between Nestlé and the Company in proportion to the amount spent by each Party in respect of such actions (including, without limitation, advisers fees and reasonable management time).
7.5. Third Party Claims.
7.5.1. Third Party Claims Course of Action . If the Development, Commercialization or Manufacture of HMPL-004 or the Product under this Agreement is alleged by a Third Party to infringe a Third Partys Patent Right(s) or misappropriate a Third Partys trade secret or has otherwise resulted in a claim in respect of product liability arising from or relating to HMPL-004 or a Product, the Party becoming aware of such allegation will promptly notify the other Party thereof, in writing, reasonably detailing the claim.
7.5.2. Third Party Suit . If a Third Party sues a Party (the Sued Party ) alleging that the Sued Partys or the Sued Partys Sublicensees Development, Manufacture or Commercialization of HMPL-004 or the Product infringes or will infringe said Third Partys Patent Right(s) or misappropriates said Third Partys trade secret or has otherwise resulted in a claim in respect of product liability arising
from or relating to HMPL-004 or a Product, then at Nestlés option, the Company will defend or settle such claim in its own name after consultation with Nestlé and in connection with its defense of any such Third Party suit, Nestlé will provide reasonable assistance to the Company for such defense and will join such suit if deemed a necessary party. The Company will keep Nestlé reasonably informed, in person or by telephone, prior to and during the pendency of any such suit, where Nestlé has not joined in such suit the information will be provided at minimum on a monthly basis. Where the Company will defend such claim, the Company will have full control of such litigation or steps but will not, without the prior written consent of Nestlé, such consent not to be unreasonably withheld, enter into any compromise or settlement relating to such litigation, including without limitation that (a) admits the invalidity or unenforceability of any Company Patent Right or any other Patent Right of Nestlé or its Affiliates or (b) requires the Company to abandon any Company Patent Right or requires Nestlé or its Affiliates to abandon any other Patent Right of Nestlé or its Affiliates (c) admits to any defect in HMPL¬004 or a Product which has, or could have contributed to, a product liability claim. Nestlé will, at its own expense, cooperate with the Company in any such litigation. Nestlé may however elect to defend or settle such claim on behalf of the Company in which case Nestlé will have full control of such litigation or steps and will defend or settle such claim in its own name and/or on behalf of the Company after consultation with the Company and in connection with its defense of any such Third Party suit, the Company will provide reasonable assistance to Nestlé for such defense and will join such suit if deemed a necessary party. Nestlé will keep the Company reasonably informed, in person or by telephone, prior to and during the pendency of any such suit, where the Company has not joined in such suit the information will be provided at minimum on a monthly basis. Where Nestlé will defend such claim, Nestlé will have full control of such litigation or steps but will not, without the prior written consent of the Company, such consent not to be unreasonably withheld, enter into any compromise or settlement relating to such litigation, including without limitation that (a) admits the invalidity or unenforceability of any Company Patent Right or (b) requires the Company to abandon any Company Patent Right (c) admits to any defect in HMPL-004 or a Product which has, or could have contributed to, a product liability claim. The Company will, at its own expense, cooperate with Nestlé in any such litigation.
7.6. Patent Certifications. Each Party will immediately give written notice to the other if it becomes aware that any Company Patent Rights covering a Product are invalid or that infringement will arise from the manufacture, use, import, sale or offer for sale of a Third Party product by a Third Party. If the Company decides not to bring infringement proceedings against the Third Party making such a claim with respect to any Product, the Company will give notice to Nestlé of its decision not to bring suit within [**] Business Days after receipt of notice of such claim (or, if the time period permitted by law is less than [**] Business Days, within half of the time period permitted by law for the Company to commence such action) and Nestlé may then, but will not be obligated to, bring suit against the Third Party that filed such claim. Any suit by either Party may be in the name of either or both Parties, as may be required by law. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit as may be reasonably requested by the Party bringing suit.
7.7. Privileged Communications. In furtherance of this Agreement, it is expected that Nestlé and the Company may, from time to time, disclose to one another privileged communications with counsel, including opinions, memoranda, letters and other written, electronic and verbal communications. Such disclosures are made with the understanding that they will remain confidential, they will not be deemed to waive any applicable attorney-client privilege and that they are made in connection with the shared community of legal interests existing between the Company and Nestlé, including the community of legal interests in avoiding infringement of any valid, enforceable patents of Third Parties and maintaining the validity of Company Patent Rights.
ARTICLE VIII
TERM AND TERMINATION
8.1. Term. The term of this Agreement will commence on the Execution Date and, unless earlier terminated as provided in this Article VIII will continue in full force and effect as long as any Product is being Commercialized pursuant to this Agreement for use in the Field in any jurisdiction within the Territory (the Term ).
8.2. Termination by Nestlé.
8.2.1. Termination for Convenience. If Nestlé reasonably determines, in good faith, that it is not feasible to pursue the Commercialization of HMPL-004 or the Products in the US or Canada due to scientific, technical, regulatory or commercial reasons, then Nestlé will notify the Company thereof and the Parties will meet and discuss how to proceed; provided that, if such determination is reasonably made by Nestlé in good faith, Nestlé will have the right to terminate this Agreement in its entirety upon ninety (90) days written notice.
8.2.2. Termination At Will. Nestlé may terminate this Agreement in its entirety, for any reason or for no reason, at any time upon giving written notice to the Company at least three hundred and sixty five (365) days prior to the effective date of such termination.
8.3. Termination for Cause.
8.3.1. Termination for Material Breach of this Agreement . In the event that a Party commits a material breach of its obligations under this Agreement that is not cured within sixty (60) days (or such other time period as mutually agreed by the Parties) after such Party receives written notice from the non-breaching Party, which notice will specify the nature of the breach and demand its cure, the non-breaching Party may terminate this Agreement upon written notice to the breaching Party. Notwithstanding the foregoing, if either Party is alleged to be in material breach and disputes such termination through the dispute resolution procedures set forth in this Agreement, then the other Partys right to cure any breach of this Agreement or to terminate this Agreement will be suspended for so long as such dispute resolution procedures are being pursued by the allegedly breaching Party in good faith and, if it is finally and conclusively determined that the allegedly breaching Party is in material breach, then the breaching Party will have no further right to cure such material breach.
8.3.2. Termination for Bankruptcy . If at any time during the Term, a Party ( Bankrupt Party ), any of its creditors or other eligible party (i) files or commences a proceeding for the liquidation, bankruptcy, receivership, reorganization, rehabilitation, composition, winding-up, dissolution or judicial management or administration of the Bankrupt Party or the appointment of a liquidator, judicial manager, receiver, administrator, trustee-in-bankruptcy or other similar officer in respect of that Party or its assets, and such proceeding has not been stayed or dismissed within ninety (90) days after the filing thereof, (ii) the Bankrupt Party is unable to pay or has suspended payment of its debt generally as they become due (except debts being contested in good faith), or (iii) the creditors of the Bankrupt Party have taken over
its management (whether pursuant to a receivership or otherwise), the other Party may terminate this Agreement at any time by written notice with immediate effect.
8.4. Effect of Termination.
8.4.1. General . Except as otherwise expressly provided herein, if this Agreement terminates for any reason, all rights and obligations of each Party will cease, including all rights and licenses granted by either Party to the other Party that do not expressly survive such termination.
8.4.2. Effects of Termination . If this Agreement is terminated by the Company pursuant to Section 8.3 or by Nestlé pursuant to Section 8.2 , the following provisions will apply:
(a) Nestlé will reasonably cooperate with the Company to assure a smooth transition, at the Companys expense, of any Clinical Trials in progress related to HMPL-004 or a Product in the Field in the Territory, which the Company determines to continue in compliance with Applicable Laws and ethical guidelines applicable to the transfer or termination of any such Clinical Trials. In the event that the Company informs Nestlé that it does not intend to continue specific Development activities then in progress, costs incurred in closing out such activities will be borne by Nestlé;
(b) Until termination is effective, each Party will continue to perform its obligations under this Agreement and will pay all costs allocated to it in accordance with this Agreement;
(c) The Right of Reference granted to Nestlé pursuant to Section 2.5.1 by the Company will survive termination of the Agreement except such Right of Reference will be solely to the extent necessary for Nestlé to obtain Regulatory Approval of any Product in the Field in any jurisdiction in which Nestlé has a valid license over HMPL¬004 and/or any Product; and
(d) Nestlé will for a period of [**] calendar months after the date of termination have the right to dispose of all stocks of Products in its possession and all Products in the course of manufacture at the date of termination and will pay to the Company any royalties due in accordance with the provisions of Section 4.3 within [**] days after the end of such period of [**] calendar months.
8.5. Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by the Company are, and will otherwise be deemed to be, for purposes of Section 365(n) of the US Bankruptcy Code, licenses of rights to intellectual property as defined under Section 101 of the US Bankruptcy Code. The Parties agree that the Company, as licensee of certain rights under this Agreement, will retain and may fully exercise all of its rights and elections under the US Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against the Company under the US Bankruptcy Code, Nestlé will be entitled to a complete duplicate of (or complete access to, as appropriate) any Intellectual Property licensed to Nestlé and all embodiments of such Intellectual Property, which, if not already in such other Partys possession, will be promptly delivered to it (a) upon any such commencement of a bankruptcy proceeding upon Nestlés written request therefor, unless the Company elects to continue to perform all of its obligations under this Agreement or (b) if not delivered under clause (a), following the rejection of this Agreement by the Company upon written request therefor by Nestlé.
8.6. Survival of Certain Obligations. Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing before such expiration or termination. The
provisions of this Agreement that must, by their nature, survive expiration or termination of this Agreement to give effect to their intent, will so survive, including Section 5.1 ( Confidentiality ), Section 9.1 ( Indemnification by the Company ) and Section 9.2 ( Indemnification by Nestlé ).
ARTICLE IX
PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE
9.1. Indemnification by the Company. The Company will indemnify, defend and hold harmless Nestlé, its Affiliates, and each of its and their respective employees, officers, directors, agents and Sublicensees (each, a Nestlé Indemnified Party ) from and against, and covenants to pay on demand to a Nestlé Indemnified Party an amount equal to the aggregate of, all liabilities, obligations, judgments, liens, injunctions, charges, orders, decrees, rulings, damages, dues, assessments, taxes, losses, fines, penalties, expenses, fees, costs, amounts paid in settlement (including reasonable attorneys and expert witness fees and disbursements in connection with investigating, defending or settling any action or threatened action), arising out of any claim, damages, complaint, demand, cause of action, audit, investigation, hearing, action, suit or other proceeding asserted or initiated (collectively, Liability ) that a Nestlé Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of:
9.1.1. any Company representation or warranty set forth herein being untrue in any material respect when made or any material breach by the Company of any of its covenants or obligations hereunder;
9.1.2. the gross negligence or willful misconduct by or of the Company, its Affiliates and their respective officers, directors, agents and Sublicensees in performing any of their obligations under this Agreement; or
9.1.3. the Development, Commercialization, Manufacture or other use of HMPL-004 or a Product by the Company, its Affiliates or Sublicensees (excluding Nestlé and its Affiliates and Sublicensees),
except in each case, to the extent caused by the gross negligence or willful misconduct of Nestlé or any Nestlé Indemnified Party, or by breach of this Agreement by Nestlé.
9.2. Indemnification by Nestlé. Nestlé will indemnify, defend and hold harmless the Company, its Affiliates, and each of its and their respective employees, officers, directors, agents and Sublicensees (each, a Company Indemnified Party) from and against, and covenants to pay on demand to a Nestlé Indemnified Party an amount equal to the aggregate of all Liabilities that a Company Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of:
9.2.1. any Nestlé representation or warranty set forth herein being untrue in any material respect when made or a material breach by Nestlé of any of its covenants or obligations hereunder; or
9.2.2. the gross negligence or willful misconduct by or of Nestlé, its Affiliates and their respective officers, directors, agents and Sublicensees in performing any of their obligations under this Agreement; or
9.2.3. the Commercialization or other use of HMPL-004 or any Product by Nestlé, its Affiliates or Sublicensees;
except in each case, to the extent caused by the gross negligence or willful misconduct of the Company or any Company Indemnified Party, or by breach of this Agreement by the Company. For the avoidance of doubt, no claim will be made under this Section 9.2 in respect of any Liability in respect of which Nestlé has a claim against the Company pursuant to this Agreement.
9.3. Procedure. In respect of all claims under the indemnities which do not fall within Section 7.4 , Section 7.5 and/or Section 7.6 , the following provisions shall apply:
9.3.1. Each Party will notify the other in the event it becomes aware of a claim for which indemnification may be sought hereunder or for which Liability is shared pursuant to this Article IX . In case any proceeding (including any governmental investigation) will be instituted involving any Party in respect of which indemnity may be sought pursuant to this Article IX , the Party benefitting from the rights under the indemnity (the Indemnified Party ) will provide the other Party (the Indemnifying Party ) with prompt written notice of such proceeding (the Indemnification Claim Notice ). Promptly after the Indemnifying Party receives the Indemnification Claim Notice, the Indemnifying Party and Indemnified Party will meet to discuss how to respond to any claims that are the subject matter of such proceeding.
9.3.2. Subject to the consent of the Indemnified Party, the Indemnifying Party may assume the defense of any Third Party claim subject to indemnification as provided for in this Section 9.3 by giving written notice to the Indemnified Party.
9.3.3. Upon assuming the defense of a Third Party claim in accordance with this Section 9.3 , the Indemnifying Party will be entitled to appoint lead counsel in the defense of the Third Party claim. Should the Indemnifying Party assume and continue the defense of a Third Party claim, except as otherwise set forth in this Section 9.3 , the Indemnifying Party will not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party claim, other than reasonable fees (including legal fees) incurred by the Indemnified Party in providing such assistance as requested by the Indemnifying Party.
9.3.4. Without limiting this Section 9.3 , any Indemnified Party will be entitled to participate in, but not control, the defense of a Third Party claim for which it has sought indemnification hereunder and to employ counsel of its choice for such purpose; provided , however , that such employment will be at the Indemnified Partys own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party has failed to assume and actively further the defense and employ counsel in accordance with this Section 9.3 (in which case the Indemnified Party will control the defense). With respect to any Liabilities in connection with Third Party claims, where the Indemnifying Party has assumed the defense of the Third Party claim in accordance with this Section 9.3 , the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Liability provided that: (i) it obtains the prior written consent of the Indemnified Party (which consent will be at the Indemnified Partys
reasonable discretion), or (ii) the Liability relates solely to the payment of money damages in connection with a Third Party claim that will not result in the Indemnified Party or any of its Affiliates becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnified Party or any of its Affiliates or Sublicensees in any manner, and the Indemnifying Party has first confirmed in writing its agreement to indemnify the Indemnified Party, its Affiliates and Sublicensees with respect to such Liability.
9.3.5. The Indemnifying Party that has assumed the defense of the Third Party claim in accordance with this Section 9.3 will not be liable for any settlement or other disposition of a Liability by an Indemnified Party (but in no event to include any court judgment or judicial or administrative order or disposition) that is reached without the written consent of such Indemnifying Party. To the extent permitted under Applicable Laws, the Indemnified Party will not admit any liability with respect to, or settle, compromise or discharge, any Third Party claim without first discussing with the Indemnifying Party the opportunity for the Indemnifying Party to assume the defense of the Third Party claim in accordance with this Section 9.3 . If the Indemnified Party consents to the Indemnifying Party assuming conduct of any Third Party claim, the Indemnified Party will cooperate in the conduct thereof and will 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 with such Third Party claim. Such cooperation will include access during normal business hours afforded to 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 employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.
9.4. Insurance. The Parties will maintain insurance with creditworthy insurance companies or self-insure in accordance with Applicable Laws against such risks and in such amounts as are usually maintained or insured against by other companies of established repute engaged in the same or a similar business.
ARTICLE X
MISCELLANEOUS
10.1. Governing Law, Jurisdiction; Dispute Resolution.
10.1.1. Governing Law . The interpretation and construction of this Agreement (including any non-contractual claims) will be governed by the laws of England and Wales.
10.1.2. Dispute Resolution . In the event of a dispute arising out of or relating to this Agreement, (including regarding its existence, termination or validity) (a Dispute ) any Party will provide written notice of the Dispute to the other Parties, in which event the Dispute will be referred to the executive officers of the Parties designated below or their successors. The designated officers will use reasonable efforts to attempt resolution by good faith negotiations within [**] days after such notice is received. Said designated officers are initially as follows:
For the Company: |
The General Manager and Finance Director |
|
|
For Nestlé: |
President and Chief Executive Officer |
In the event the designated executive officers do not resolve such Dispute within the allotted [**] days, any Party may, after the expiration of the [**] day period, seek to resolve the Dispute through reference to arbitration in accordance with Section10.1.3 . Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, will not be deemed a Dispute which may be referred for resolution by the Parties under this Section 10.1.2 .
10.1.3. Arbitration . All Disputes which are unresolved pursuant to Section 10.1.2 and which a Party wishes to have resolved will be referred upon the application of any Party to, and finally settled by, arbitration in accordance with the ICC Arbitration Rules (the Rules ) as in force at the date of this Agreement and as modified by this Section 10.1.3 , which Rules are deemed incorporated into this Section 10.1.3 . The number of arbitrators will be three (3), one of whom will be appointed by each Party and the third of whom, who will act as chairman, will be nominated by the two party-nominated arbitrators, provided that if the third arbitrator has not been nominated within twenty (20) Business Days of the nomination of the second party-nominated arbitrator, such third arbitrator will be appointed by the ICC. The seat of arbitration will be London and the language of arbitration will be English.
The arbitrators will have the power to grant any legal or equitable remedy or relief available under law, including injunctive relief (whether interim and/or final) and specific performance, and any measures ordered by the arbitrators may be specifically enforced by any court of competent jurisdiction. Each Party retains the right to seek interim or provisional measures, including injunctive relief and including pre-arbitral attachments or injunctions, from any court of competent jurisdiction and any such request will not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate. For the avoidance of doubt, this Section 10.1.3 is not intended to limit the powers of the court exercisable in support of arbitration proceedings pursuant to Section 44 of the Arbitration Act 1996 or any Applicable Laws.
10.2. Force Majeure. No liability will result from, and no right to terminate will arise, in whole or in part, based upon any delay in performance or non-performance, in whole or in part, by either of the Parties to this Agreement to the extent that such delay or non-performance is caused by an event of Force Majeure. Force Majeure means an event that is beyond a non-performing Partys control, including an act of God, strike, lock-out or other industrial/labor dispute not involving the non-performing Partys (or its Affiliates) own employees, war, riot, terrorist act, epidemic, quarantine, fire, flood or natural disaster. The Force Majeure Party will within ten (10) days of the occurrence of the Force Majeure event, give written notice to the other Party stating the nature of the Force Majeure event, its anticipated duration and any action being taken to avoid or minimize its effect. Any suspension of performance will be of no greater scope and of no longer duration than is reasonably required and the Force Majeure Party will use reasonable effort to remedy its inability to perform; provided , however , if the suspension of performance continues or is anticipated to continue for thirty (30) days after the date of the occurrence, the unaffected Party will have the right but not the obligation to perform on behalf of the Force Majeure Party for a period of such Force Majeure and such additional period as may be
reasonably required to assure a smooth and uninterrupted transition of such activities. If such failure to perform would constitute a material breach of this Agreement in the absence of such event of Force Majeure, and continues for [**] months from the date of the occurrence and the Parties are not able to agree on appropriate amendments within such period, the unaffected Party will have the right, notwithstanding the first sentence of this Section 10.2 , to terminate this Agreement immediately by written notice to the Force Majeure Party, in which case neither Party will have any liability to the other except for those rights and liabilities that accrued prior to the date of termination.
10.3. Waiver and Non-Exclusion of Remedies. A Partys failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy will 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
10.4. Notices.
10.4.1. Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 10.4.2 or to such other address as the Party to whom notice is to be given may have provided to the other Parties in accordance with this Section 10.4.1 . Such Notice will be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second (2) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 10.4 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.
10.4.2. Address for Notice .
The Company:
Nutrition Science Partners Limited
22nd Floor, Hutchison House
10 Harcourt Road, Hong Kong
Attn: General Manager
Fax: +852 2128 1778
With a copy to:
The Finance Director
c/o Nestlé Health Science S.A.
Avenue Nestlé 55,
1800 Vevey Switzerland
Attn: General Counsel
Nestlé:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: President and Chief Executive Officer
With a copy to:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: General Counsel
10.5. Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter hereof. All Schedules 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 and this Agreement, the terms of this Agreement will govern.
10.6. Amendment. Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of all Parties.
10.7. Assignability. This Agreement and each and every covenant, term and condition hereof will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Neither this Agreement nor any rights or obligations hereunder may be assigned, delegated or transferred, directly or indirectly, by a Party to any Third Party without the prior written consent of the other Party except that Nestlé may assign this Agreement and any rights hereunder to any of its Affiliates. Any attempted assignment or delegation in violation of this Section 10.7 will be void.
10.8. No Benefit to Others. The provisions of this Agreement are for the sole benefit of the Parties and their Affiliates, successors and permitted assigns, and they will not be construed as conferring any rights in any other Persons except as otherwise expressly provided in this Agreement. A Person who is not a party to this Agreement will have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of its terms.
10.9. Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which taken together will be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission will be as effective as an original executed signature page.
10.10. Severability. To the fullest extent permitted by Applicable Laws, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and will not form part of this Agreement. To the fullest extent permitted by Applicable Laws and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement will remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Laws and achieves, as nearly as possible, the original intention of the Parties.
10.11. Further Assurance. Each Party will perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
10.12. Publicity. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of any subsequent press releases relating to the Agreement or the activity hereunder prior to the issuance thereof, provided that a Party may not unreasonably withhold consent to such releases, and that any Party may issue such press releases as it determines, based on advice of counsel, are reasonably necessary to comply with Applicable Laws, judgments, decrees, orders or for appropriate market disclosure or which are consistent with information disclosed in prior releases properly made hereunder.
10.13. Relationship of the Parties. The status of a Party under this Agreement will be that of an independent contractor. Nothing contained in this Agreement will 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 or any of its Affiliates will be employees of such Party or its Affiliates and not of the other Party or such other Partys Affiliates and all costs and obligations incurred by reason of any such employment will be for the account and expense of such Party or its Affiliates, as applicable.
10.14. 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 in the event of any conflict in interpretation between the English version and such translation, the English version will prevail. English will be the official language of this Agreement and all communications between the Parties will be conducted in that language.
10.15. Construction. Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word or has the inclusive meaning represented by the phrase and/or. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Schedules or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms including, include(s), such as, and for example as used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by without limitation.
[Signature Page Follows]
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed and intend to and hereby do deliver this Agreement as a deed to be effective as of the Execution Date.
SEALED with the COMMON SEAL of |
[Signature of Christian Hogg] |
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SIGNATURE PAGE TO LICENSE AGREEMENT
Schedule 1.13
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[Validity of patents and inclusion of any additional Company Patent Rights to be confirmed by the Parties at the time of execution.]
Appendix A
Independent Expert Appointment Procedure
1. If the Parties fail to agree upon an independent Third Party expert within fifteen (15) Business Days of either Party providing written notice to the other notifying of a requirement to appoint an independent Third Party expert pursuant to the terms of the Agreement, either Party may refer the matter to ICC in London for determination in accordance with the ICC Rules of Expertise.
2. The determination made by the expert pursuant to the ICC Rules of Expertise will be final and binding upon the Parties. The language to be used in the expert determination will be English.
EXHIBIT B TO OPTION AGREEMENT
LICENSE AGREEMENT (EUROPE)
by and between
NUTRITION SCIENCE PARTNERS LIMITED
and
NESTLÉ HEALTH SCIENCE S.A.
[DATE]
TABLE OF CONTENTS
Article I DEFINITIONS |
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Article II GRANT OF RIGHTS |
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Article III DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION |
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Schedules
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Schedule 1.33 |
HMPL-004 |
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Key Patent Rights |
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Schedule 6.2 |
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LICENSE AGREEMENT
This LICENSE AGREEMENT (the Agreement ) is entered into as a deed on this [DATE] (the Execution Date ), by and among Nutrition Science Partners Limited, a limited company organized and existing under the laws of Hong Kong with its principal offices at 22nd Floor, Hutchison House, 10 Harcourt Road, Hong Kong (the Company ) and Nestlé Health Science S.A., a company organized and existing under the laws of Switzerland with its principal offices at Rue des Remparts 2, 1095 Lutry, Switzerland ( Nestlé ). Nestlé and the Company are hereinafter referred to collectively as the Parties and individually as a Party .
RECITALS
WHEREAS, pursuant to the Joint Venture Agreement dated as of [ · ] November 2012 (as such may be amended from time to time in accordance with its terms, the Joint Venture Agreement ), Hutchison MediPharma (Hong Kong) Limited, a limited company organized and existing under the laws of Hong Kong ( Hutchison ), Hutchison China MediTech Limited, a company organized and existing under the laws of the Cayman Islands, the Company and Nestlé agreed to form the Company, a joint venture, in part for the purpose of the discovery, development, registration, manufacture and commercialization of Products in the Field;
WHEREAS, in connection with such joint venture, the Company granted to Nestlé, inter alia, pursuant to an Option Agreement dated as of [DATE] (as such may be amended from time to time in accordance with its terms, the Option Agreement ), an exclusive option to obtain an exclusive royalty-bearing license to Commercialize HMPL-004 and any Products in the Field in the Territory; and
WHEREAS, Nestlé has exercised such option on the terms set forth therein and the Parties have obtained (where required) all regulatory clearance for this Agreement.
NOW THEREFORE, in consideration of the mutual promises and covenants set forth below and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
ARTICLE I
DEFINITIONS
The terms defined in this Article will have the meanings ascribed to them herein whenever they are used in the Agreement, unless otherwise clearly indicated by the context.
1.1. Affiliate(s) means, with respect to a Person, any Person that controls, is controlled by, or is under common control with such first Person. For purposes of this definition only, control means (a) to possess, directly or indirectly, the power to direct the management or policies of a Person, whether through ownership of voting securities or by contract relating to voting rights or corporate governance, or otherwise, or (b) to own, directly or indirectly, more than fifty per cent (50%) of the outstanding voting rights exercisable at a shareholder meeting (or equivalent), or other ownership interests of such Person. Notwithstanding the foregoing, in no
event will Nestlé be considered an Affiliate of the Company or will the Company be considered an Affiliate of Nestlé or any of its Affiliates.
1.2. Agreement will have the meaning set forth in the introduction to this Agreement.
1.3. Applicable Laws means all applicable laws, statutes, ordinances, regulations, rules, guidance, or orders of any kind whatsoever (including without limitation from any Regulatory Authority), including (without limitation) those applicable to the Parties and/or transactions contemplated under this Agreement.
1.4. Business Day means a day on which banks are open for normal banking business (excluding Saturday, Sunday and public holidays) in Hong Kong, Peoples Republic of China and Switzerland (Canton de Vaud).
1.5. Calendar Quarter means, with respect to a given Calendar Year, means the respective periods of three consecutive calendar months ending on March 31, June 30, September 30 and December 31.
1.6. Calendar Year means any calendar year, beginning on January 1 and ending on December 31.
1.7. Clinical Trial means a human clinical study conducted on sufficient numbers of human subjects that is designed to (i) establish that a pharmaceutical product, food supplement or a medical food product is reasonably safe for continued testing, (ii) investigate the safety and efficacy of the pharmaceutical product, food supplement or the medical food product for its intended use, and to define warnings, precautions and adverse reactions that may be associated with the pharmaceutical product, food supplement or the medical food product in the dosage range to be prescribed or (iii) support Regulatory Approval of such pharmaceutical product, food supplement or medical food product or label expansion or demonstration of benefit of such pharmaceutical product, food supplement or medical food product, all in accordance with Applicable Laws.
1.8. Combination Product will have the meaning set forth in Section 1.50 .
1.9. Commercialization means any and all activities of using, importing, exporting, marketing, promoting, distributing, offering for sale or selling a Product including pre-commercial launch market development activities conducted in anticipation of Regulatory Approval of a Product, seeking pricing and reimbursement approvals for a Product, if applicable, preparing advertising and promotional materials, sales force training, all interactions and correspondence with a Regulatory Authority regarding Post-Approval Clinical Trials, all activities required to fulfill ongoing regulatory obligations, including adverse event reporting and all activities relating to the licensing of a Product (including sourcing and negotiations with potential licensees). When used as a verb, Commercialize means to engage in Commercialization.
1.10. Commercially Reasonable Efforts means, with respect to a Party, those efforts and resources that such Party or its Affiliates would reasonably devote to a product or compound owned by it or to which it has rights of the type it has hereunder, which is of similar market potential at a similar stage in its development or product life, taking into account the competitiveness of the global and local marketplace, the nature and extent of market exclusivity (including patent coverage and regulatory exclusivity), the pricing and launching strategy for the respective product, the proprietary position of the product, the profitability and the relative potential safety and efficacy of the product and other relevant factors, including technical, legal, scientific, regulatory or medical factors, all as measured by the facts and circumstances at the time such efforts are due. Commercially Reasonable as used herein will be interpreted in a corresponding manner.
1.11. Company Indemnified Party has the meaning set forth in Section 9.2 .
1.12. Company Know-How means Information that is Controlled by the Company as of the Execution Date or after the Execution Date and until the end of the Term, that is necessary or useful for the use, Development or Commercialization of HMPL-004 or a Product including any Improvements, from time to time.
1.13. Company Patent Rights means any Patent Right that is Controlled by the Company as of the Execution Date or after the Execution Date and until the end of the Term, that is necessary or useful for the use, Development or Commercialization of HMPL-004 or a Product including any Improvements, from time to time. The Company Patent Rights existing as of the Execution Date are set forth on Schedule 1.13 and include the Key Patent Rights.
1.14. Company Portion has the meaning set forth in Section 4.2.3(a) .
1.15. Company Technology means the Company Know-How, Company Patent Rights, and all other Intellectual Property Rights in any of the foregoing.
1.16. Confidential Information means, with respect to a Party, all Information which is Controlled by such Party and is disclosed by such Party to another Party pursuant to this Agreement.
1.17. Control or Controlled means, with respect to any Intellectual Property Right, Information, documents or materials, the possession, ownership, the ability to use pursuant to a license or sublicense and the ability to license or sublicense to another person, of such Intellectual Property Right, Information, document or materials, by a Party or any of its Affiliates (other than pursuant to this Agreement, the Governing Agreements and/or any other license agreement between the Parties) as provided in this Agreement without violating an agreement with or other rights of any Third Party; it being understood and agreed that the term Control will not apply to any Intellectual Property right for which the licensing Party will be required to make any payments to any Third Party in connection with the licenses granted under this Agreement unless, but only if and for such time that, the other Party agrees and does promptly pay to the licensing Party all such payments arising out of the grant of the license to the other Party (as so mutually agreed between the Parties in good faith).
1.18. Development means pre-clinical and clinical activities performed by or on behalf of the Company with respect to Products in an indication in the Field in a jurisdiction in the Territory for the purpose of obtaining and maintaining Regulatory Approval with respect to such indication in such jurisdiction and activities performed by or on behalf of the Company with respect to Products destined as medical food products. Development will include, without limitation, all activities related to discovery, research, pre-clinical testing, test method development and stability testing, toxicology, formulation, Clinical Trials, seeking Regulatory Approval and otherwise handling regulatory affairs and statistical analysis with respect to Products. Notwithstanding anything to the contrary in this Agreement, Development will not include Manufacturing or Commercialization. When used as a verb, Develop means to engage in Development.
1.19. Disclosing Party has the meaning set forth in Section 5.1.1 .
1.20. Dispute has the meaning set forth in Section 10.1.2 .
1.21. Execution Date will have the meaning set forth in the introduction to this Agreement.
1.22. Field means any and all uses, including without limitation, the treatment, prevention or diagnosis of gastrointestinal diseases, disorders or conditions in humans.
1.23. Financial Records has the meaning set forth in Section 4.3.5 .
1.24. First Commercial Sale means, with respect to any Product, the first arms length sale of such Product by Nestlé or its Affiliate or Sublicensee to a Third Party in a jurisdiction in the Territory after such Product has been granted Regulatory Approval by the appropriate Regulatory Authority(ies) for such jurisdiction.
1.25. First Regulatory Approval for [**] means the approval for a Product for [**].
1.26. First Regulatory Approval for [**] means the approval for a Product for [**].
1.27. First Regulatory Approval for [**] means the approval for a Product for [**].
1.28. First Regulatory Approval for [**] means the approval for a Product for [**].
1.29. Force Majeure has the meaning set forth in Section 10.2 .
1.30. Generic Product means, on a country-by-country basis and Product-by-Product basis, [**].
1.31. Governing Agreements means this Agreement, the Joint Venture Agreement, the Option Agreement, the Research and Development Collaboration Agreement and the Services Agreements.
1.32. Government Authority means any court, agency, department, authority, regulatory body or other instrumentality of any national, state, county, city or other government or political subdivision.
1.33. HMPL-004 means (i) the compound designated by Hutchison as HMPL-004, [**].
1.34. ICC means the International Chamber of Commerce.
1.35. Improvement means any improvement, enhancement, modification, addition or other change to any Company Technology to the extent necessary or useful for the use, Development or Commercialization of HMPL-004.
1.36. Indemnification Claim Notice has the meaning set forth in Section 9.3 .
1.37. Indemnified Party has the meaning set forth in Section 9.3 .
1.38. Indemnifying Party has the meaning set forth in Section 9.3 .
1.39. Information means any data, results, technology or information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical and clinical test data and data resulting from non-clinical studies), chemistry, manufacturing and controls information, stability data and other study data and procedures.
1.40. Infringement has the meaning set forth in Section 7.4.1 .
1.41. Intellectual Property means (i) any intellectual property or related proprietary rights in any jurisdiction, whether owned or held for use under license, whether registered or unregistered, including such rights in (a) all inventions, invention disclosures and improvements thereto (whether patentable or unpatentable and whether or not reduced to practice), all issued patents and pending patent applications, any divisions, continuations, continuations-in-part, reissues, continuing patent applications, reexaminations and extensions thereof and any counterparts claiming priority therefrom, and all utility models, design patents, patents of importation/confirmation, certificates of invention, certificates of registration and similar rights, (b) all trademarks, service marks, certification marks, trade dresses, logos, trade names and corporate names, including all goodwill associated therewith, and all applications, registrations and renewals in connection therewith, (c) all works of authorship (whether or not copyrightable), all copyrights, all moral rights and all applications, registrations and renewals in connection
therewith, (d) all trade secrets and confidential business information and any rights to limit the use or disclosure thereof by any Person (including ideas, research and development, know-how, formulas, compositions, manufacturing and production processes and techniques, technical data, designs, drawings, specifications, customer and supplier lists, pricing and cost information, and business and marketing plans and proposals), and (e) internet domain names, (ii) all copies and tangible embodiments of any of the foregoing (in whatever form or medium) and (iii) any goodwill associated with the foregoing.
1.42. Intellectual Property Rights will mean any and all rights in relation to the Intellectual Property licensed pursuant to this Agreement or thereafter coming into existence, and all applications for, renewals of and extensions of the foregoing, regardless of whether or not such rights have been registered with the appropriate authorities in such jurisdictions in accordance with the Applicable Laws.
1.43. Joint Venture Agreement will have the meaning set forth in the recitals to this Agreement.
1.44. Key Patent Rights means Company Patent Rights set forth in Schedule 1.44 .
1.45. Liability has the meaning set forth in Section 9.1 .
1.46. License Agreement means this Agreement.
1.47. Manufacture, Manufactured or Manufacturing means all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, shipping and storage of Products to be Developed or Commercialized in the Territory, including active pharmaceutical ingredient manufacturing, whether such activities are conducted by the Company, its Affiliates or a Third Party contractor of such Party (under a contract manufacturing or tolling arrangement). Notwithstanding the foregoing, Manufacturing will not mean Developing or Commercializing. When used as a verb, Manufacture means to engage in Manufacturing.
1.48. Nestlé will have the meaning set forth in the introduction to this Agreement.
1.49. Nestlé Indemnified Party has the meaning set forth in Section 9.1 .
1.50. Net Sales means, on a country-by-country and Product-by-Product basis, the gross amounts invoiced by Nestlé, its Sublicensees or its Affiliates, as applicable, to Third Parties for sales of a Product in the Field in such country, less the following deductions to the extent included in the gross invoiced sales price for such Product or otherwise paid or incurred by Nestlé, its Sublicensees or its Affiliates with respect to the sale of such Product in such country:
(a) [**]
(b) [**]
(c) [**]
(d) [**]
(e) [**]
(f) [**].
[**].
Notwithstanding the foregoing, in the event a Product is sold as a combination product that includes the HMPL-004 and an active agent that is not HMPL-004 (such combination product, the Combination Product ), Net Sales will be calculated by multiplying the Net Sales of the Combination Product by the fraction A/(A+B), where A is the gross average invoice price of the Product during the relevant Calendar Quarter if sold separately in a country and B is the gross average invoice price of the other product(s) included in the Combination Product during the relevant Calendar Quarter if sold separately in such country. In the event no such separate sales are made by Nestlé, its Affiliates or Sublicensees in a country, Net Sales of the Combination Product will be calculated in a manner to be negotiated and agreed upon by the Parties, reasonably and in good faith, prior to any sale of such Combination Product, which will be based upon the respective cost of goods sold of the active components of such Combination Product.
1.51. New Third Party Licenses will have the meaning set forth in Section 4.2.3(a) .
1.52. Option Agreement has the meaning given in the recitals to this Agreement.
1.53. Party and Parties will have the meaning set forth in the introduction to this Agreement.
1.54. Party IP will have the meaning set forth in Section 2.3 .
1.55. Patent Right means any and all (i) national and international patent applications filed under Applicable Laws in any jurisdiction, including all provisional applications, substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (ii) all patents, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, (iii) utility models, petty patents or similar rights or protections based on the patent or patent applications or on the priority applications on which the patent or patent applications are based and includes all divisional, continuations, continuations-in-part, renewals and reissues of such patents, patent applications, utility models, petty patents, and (iv) any other rights or protections similar to any of the foregoing.
1.56. Person means 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 or department or agency of a government.
1.57. Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.
1.58. Post-Approval Clinical Trial means any Clinical Trial for use of a Product in an indication, other than a Phase IV Clinical Trial, to be conducted after a Regulatory Approval for such indication.
1.59. Product means any pharmaceutical product, food supplement or medical food product in finished form that contains HMPL-004, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.
1.60. Receiving Party has the meaning set forth in Section 5.1.1 .
1.61. Regulatory Approval means, with respect to a Product, the approval and authorization of a Product by a Regulatory Authority in a jurisdiction where such Product will be Manufactured or Commercialized, including, with respect to the Commercialization of such Product, pricing approval.
1.62. Regulatory Authority means any supranational, European, national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with jurisdiction in one or more of the countries of the Territory involved in the granting of Regulatory Approvals.
1.63. Regulatory Submissions means applications for Regulatory Approval, notification and other submissions made to or with a Regulatory Authority that are necessary or reasonably desirable to Develop, Manufacture or Commercialize a Product in the Field in one or more of the countries in the Territory, whether obtained before or after a Regulatory Approval in such countries. Regulatory Submissions include, without limitation, investigational new drug applications and new drug applications, and amendments and supplements to any of the foregoing and their foreign counterparts, applications for pricing and reimbursement approvals, and all proposed labels, labeling, package inserts, monographs and packaging for a Product in a particular jurisdiction.
1.64. Research and Development Collaboration Agreement means that Research and Development Collaboration Agreement entered into by 和记黄埔医药 ( 上海 ) 有限公司 Hutchison MediPharma Limited, Nestlé Health Science S.A. and the Company dated as of [ · ].
1.65. Right of Reference means a right of reference relating to data included in any Regulatory Submissions in accordance with Applicable Laws and as further described in Section 2.5 .
1.66. Rules has the meaning set forth in Section 10.1.3 .
1.67. Services Agreements means that Services Agreement entered into by 和记黄埔医药 ( 上海 ) 有限公司 Hutchison MediPharma Limited and the Company dated as of [ · ] and the Services Agreement entered into by Nestlé and the Company dated as of [ · ].
1.68. Sublicense means an agreement or arrangement pursuant to which such a sublicense has been granted to a Sublicensee.
1.69. Sublicensee means an Affiliate or Third Party that is granted a license, sublicense or other grant of rights under the licenses granted pursuant to Article II of this Agreement.
1.70. Sublicensee Material Breach has the meaning set forth in Section 2.4.2 .
1.71. Sublicensor means a Party that has granted a Sublicense under rights granted to such Party under this Agreement.
1.72. Sued Party has the meaning set forth in Section 7.5.2 .
1.73. Term has the meaning set forth in Section 8.1 .
1.74. Territory will mean [**].
1.75. Third Party means any Person other than the Company and its Affiliates and Nestlé and its Affiliates.
1.76. Trademark means any trademark of the Company in connection with a Product in accordance with Section 7.3 .
1.77. US means the United States of America.
1.78. Withholding Taxes will have the meaning set forth in Section 4.3.2(a) .
ARTICLE II
GRANT OF RIGHTS
2.1. License to Nestlé. Subject to the terms and conditions of this Agreement, the Company hereby grants to Nestlé, effective on the Execution Date an exclusive (exclusive even as to the Company and its Affiliates) and, subject to Section 8.4 , irrevocable license, with the right to Sublicense as set forth in Section 2.4 , of the Company Technology, to use, have used, Commercialize and have Commercialized (but, subject to Section 3.3 , in no event Manufacture or have Manufactured) HMPL-004 and any Products in the Field in the Territory during the Term in accordance with the terms of this Agreement.
2.2. Improvements to Company Technology. The Company will from time to time promptly disclose to Nestlé and its Affiliates full details of any and all Improvements made by, or on behalf of, the Company or any of its Affiliates during the Term. Any such Improvements will be owned by the Company, and if subject to patent protection will form part of the Company
Patent Rights or, if unpatented, will form part of the Company Know-How without any variation to the royalties payable by Nestlé under this Agreement.
2.3. Non Specific New Technology. Each Party will notify the other of any invention or discovery by such Party, its Affiliates, licensees or Sublicensees or Third Parties acting on their behalf, of any Intellectual Property, Patent Right or know-how (which is not an Improvement and does not form part of the Company Technology) of a general nature which is not specific to, but could reasonably be beneficial or helpful for the Commercialization of HMPL-004 ( Party IP ). Following receipt of such notice, if requested by either Party, the Parties will discuss in good faith the terms on which such Party IP could be licensed to the other Party (whether pursuant to an amendment to this Agreement or otherwise). For the avoidance of doubt, neither Party will be required to enter into any license with respect to such Party IP. Nothing in this Section will oblige Nestlé to disclose any business confidential information unrelated to HMPL-004.
2.4. Sublicensing.
2.4.1. Nestlé Right to Sublicense .
(a) Nestlé may, on a country-by-country basis, grant Sublicenses to its Affiliates or to Third Parties of all or a portion of the rights granted to Nestlé under this Agreement by the Company; provided that Nestlé will (i) remain responsible for the performance of its Sublicensees under this Agreement and (ii) cause its Sublicensees to comply with the terms of this Agreement.
(b) Each Sublicense granted by Nestlé of all or a portion of the rights granted to Nestlé under this Agreement (i) will be subject and subordinate to, and consistent with, the terms and conditions of this Agreement; (ii) will not diminish, reduce or eliminate any of Nestlés obligations under this Agreement; (iii) will require the Sublicensee(s) to comply with all applicable terms of this Agreement; (iv) will require that any Sublicensee grant to the Company a Right of Reference to the same extent of the Right of Reference granted to the Company pursuant to Section 2.5.2 ; and (v) will prohibit further sublicensing except on terms consistent with this Section 2.4.1 . Nestlé will provide the Company with a complete copy of each Sublicense granted to a Third Party within thirty (30) days after execution thereof; provided , however , that Nestlé may redact any Confidential Information from such Sublicense to the extent that such redactions do not reasonably impair the Companys ability to ensure compliance with this Agreement.
2.4.2. Breach of Sublicense . In the event of an uncured material breach by any Sublicensee which is an Affiliate of Nestlé under a Sublicense that would constitute a material breach of the Sublicensors obligations under this Agreement (a Sublicensee Material Breach ), the Sublicensor will provide prompt written notice of such Sublicensee Material Breach to the other Party and will use Commercially Reasonable Efforts to remedy such Sublicensee Material Breach; provided , however , that if the Sublicensor is unable to cure such Sublicensee Material Breach in accordance with Section 8.3.1 of this Agreement, such Sublicensee Material Breach will be deemed to be an uncured material breach by the Sublicensor under this Agreement.
2.4.3. Effect of Termination on Sublicenses . In the event of a termination of this Agreement pursuant to Article VIII while one or more Sublicense granted under Section 2.4 is in effect, any and all such Sublicenses will immediately terminate upon termination of this Agreement, other than Sublicenses with Third Parties, where the Sublicensee is not in material breach of the Sublicense, which will be novated by Nestlé to the Company, subject to consent of such Third Party. The relevant
Sublicensor will upon termination of this Agreement or as soon as possible thereafter, give written notice of such to the relevant Sublicensees.
2.5. Right of Reference.
2.5.1. Nestlé Right of Reference . The Company hereby grants, and will cause its Affiliates and Sublicensees to grant, to Nestlé, its Affiliates and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by the Company, its Affiliates and Sublicensees relating to HMPL-004 or a Product to the extent necessary to obtain Regulatory Approval of any Product in the Field in any country of the Territory, and the Company will provide a signed statement to this effect, if requested by Nestlé.
2.5.2. Company Right of Reference . Nestlé grants, and will cause its Affiliates and Sublicensees to grant, to the Company, its Affiliates and its Sublicensees a Right of Reference to all data included in the Regulatory Submissions and Regulatory Approvals Controlled by Nestlé, its Affiliates and Sublicensees relating specifically to HMPL-004 and the Products in the Territory (if any) to the extent necessary to obtain Regulatory Approval of any Product in the Field in any jurisdiction outside the Territory, and Nestlé will provide a signed statement to this effect, if requested by the Company.
2.6. Transfer of Regulatory Materials. As soon as reasonably practicable after the grant of Regulatory Approval for a Product, the Company will take the actions reasonably necessary to transfer ownership and, as applicable, physical possession to Nestlé of all Regulatory Approvals, material Regulatory Submissions, correspondence and related information (including any investigational new drug applications and other Regulatory Approvals) for HMPL-004 and such Product in the Territory and will notify the appropriate Regulatory Authorities of such transfer of ownership. All costs associated with such actions will be borne by the Company.
2.7. Delivery of Company Know-How. As soon as reasonably practicable after the Execution Date and in respect of any Improvement, as soon as reasonably practicable, after inclusion of such Improvement in the Company Technology, the Company will transfer to Nestlé true and complete copies of all Company Know-How (in electronic or hard copy format) with, where applicable (and within reason), a translation into English. Nestlé will not use the Company Know-How transferred to it in accordance with this Section 2.7 other than in accordance with the rights expressly granted to it under this Agreement. Except in connection with Sublicenses permitted and granted pursuant to this Article II , Nestlé will not sell or otherwise transfer any Company Know-How to any Third Party.
2.8. No Other Rights. No rights, other than those expressly set forth in this Agreement are granted to either Party hereunder, and no additional rights will be deemed granted to either Party by implication, estoppel or otherwise, with respect to any Intellectual Property rights. All rights not expressly granted by either Party to the other hereunder are reserved.
2.9. Licenses for Export.
2.9.1. This Agreement is made subject to any restrictions concerning the export of products or technical information which may be imposed upon or related to the Company or Nestlé from time to time. Each Party agrees that it will not export, directly or indirectly, any technical information acquired from the other Party pursuant to this Agreement or any Product using such technical information to a location or in a manner that at the time of export requires an export license or other governmental approval, without first obtaining the written consent to do so from the appropriate Regulatory Authority.
2.9.2. The Company will be solely responsible for obtaining any governmental licenses or approvals required in the Peoples Republic of China or elsewhere for the export of the Company Technology or any Improvement and will immediately notify Nestlé if such required licenses or approvals are refused or revoked.
ARTICLE III
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION
3.1. Information Exchange.
3.1.1. Development and Commercialization . Nestlé will report to the Company on Commercialization activities undertaken by Nestlé, its Affiliates and Sublicensees with respect to HMPL-004 and the Products by providing a reasonably detailed summary of all results and data obtained from such activities (including Nestlés Commercially Reasonable Efforts to achieve the diligence obligations set forth in Section 3.2.2 ), together with a summary of activities that Nestlé, its Affiliates and Sublicensees intend to undertake during the next [**] months with respect to HMPL-004 and the Products and a summary of Commercialization activities that Nestlé, its Affiliates and Sublicensees have undertaken in the relevant Calendar Quarter and intend to undertake during the next [**] months with respect to the Products in the relevant jurisdictions within the Territory. Such reports will be provided in English by Nestlé to the Company at least once every Calendar Quarter and Nestlé will have the right to exclude or redact all business confidential information specifically relating to Nestlé.
3.2. Diligence Requirements.
3.2.1. Of the Company . The Company will use Commercially Reasonable Efforts to conduct all Development necessary to obtain all Regulatory Approvals for HMPL-004 and/or Products in the jurisdictions within the Territory and maintain any Regulatory Approvals obtained by the Company for a Product for which the Company (or an Affiliate of the Company) has obtained Regulatory Approval in the Field in the jurisdictions within the Territory. The Company will perform, and will ensure that its Affiliates and Sublicensees perform, all activities required of it hereunder with respect to HMPL-004 and the Products, including the Development of HMPL-004 and such Products, in accordance with and pursuant to all Governing Agreements and any other applicable agreements entered into by, on the one hand, the Company, its Affiliates or Sublicensees, and, on the other hand, Nestlé, Hutchison and/or their respective Affiliates.
3.2.2. Of Nestlé . Nestlé will use Commercially Reasonable Efforts (i) to pay all applicable maintenance fees for Regulatory Approvals relating to Commercialization for HMPL-004 and the Products in such jurisdiction in the Territory for which Regulatory Approvals for HMPL-004 and the Products have been obtained (as the case may be) and (ii) to Commercialize Products that have received Regulatory Approval in the relevant jurisdiction within the Territory for use in humans in the Field as soon as reasonably practicable. Nestlé will use all Commercially Reasonable Efforts to perform, and will ensure that its Affiliates and Sublicensees use all Commercially Reasonable Efforts to perform all activities required of it hereunder with respect to HMPL-004 and the Products, including Commercialization of HMPL-004 and such Products in the relevant jurisdiction within the Territory in accordance with and pursuant to all Governing Agreements and any other applicable agreements entered into by, on one hand, Nestlé, its Affiliates or Sublicensees and, on the other hand, Hutchison, the Company and/or their respective Affiliates.
3.3. Right to Manufacture. As between Nestlé and the Company, the Company will retain all rights to Manufacture and have Manufactured HMPL-004 and the Products. Nestlé and the Company agree that the Company will be the sole source of clinical and commercial supplies of HMPL-004 and the Products to Nestlé, its Affiliates and Sublicensees, and that such supply arrangement be on a [**] and be documented in a supply agreement with reasonable terms to be negotiated by the Parties in good faith at a later date. Where the Company and Nestlé have been unable to agree the terms of the manufacturing agreement within [**] Business Days of the commencement of negotiations, or the Company is unable or unwilling to Manufacture HMPL-004 or the Products, the grant of rights to Nestlé pursuant to Section 2.1 will automatically be deemed to include the right to Manufacture and have Manufactured HMPL-004 and the Products anywhere in the world solely for Commercialization in the Field in the Territory (in which case, Nestlé will have the right to source itself any raw material required for the Manufacture of HMPL-004 and the Products).
ARTICLE IV
ROYALTIES AND PAYMENTS
4.1. Regulatory Approval Milestones.
4.1.1. Nestlé will pay the Company the following milestone payments within [**] days of the achievement of the relevant milestone event as described below:
Milestone Event |
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Milestone Payment |
[**] |
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[**] |
[**] |
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[**] |
[**] |
|
[**] |
[**] |
|
[**] |
Provided, however that in the event:
(a) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(b) the First Regulatory Approval for [**] for Maintenance does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(c) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(d) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(e) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(f) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(g) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
(h) [**] does not occur by [**] the relevant milestone payment for the delayed milestone event owed by Nestlé pursuant to this Section 4.1 will be reduced by [**].
Such deductions in clauses (a) through (h) not to be cumulatively applied.
4.2. Royalties.
4.2.1. Royalty Rates . In addition to the payments under Section 4.1.1 , in consideration for the rights granted to Nestlé under this Agreement, Nestlé will pay the Company the marginal royalties set forth below in this Section 4.2.1 on the Net Sales of the Products during each Calendar Year in each Territory, as such may be adjusted pursuant to the terms hereof.
Annual Net Sales of Products in each Territory |
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Net Sales |
[**] |
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[**] |
[**] |
|
[**] |
[**] |
|
[**] |
[**] |
|
[**] |
[**] |
|
[**] |
4.2.2. Royalty Reduction . On a country-by-country basis where, at the time of sale of a Product, (a) the Key Patent Rights that cover such Product in such country are not validly registered patents or have been rejected, challenged, opposed, cancelled or otherwise rendered ineffective ( Invalid Claim ) or (b) there is a Generic Product being sold to patients for therapeutic use in such country, any royalty otherwise payable to the Company by Nestlé under Section 4.2.1 of this Agreement with respect to Net Sales of the relevant Product in such country will be reduced by [**]. On a country-by-country basis where, at the time of sale of a Product, there is (a) an Invalid Claim or a Generic Product being sold to patients for therapeutic use in such country without infringing the Key Patent Rights and (b) a Generic Product being sold to patients for therapeutic use in such country, any royalty otherwise payable to the Company by Nestlé under Section 4.2.1 of this Agreement with respect to Net Sales of the relevant Product in such country will be reduced to [**]. Where the royalty rate for a country is reduced pursuant to this Section 4.2.2 , then for the purposes of calculating royalties under this Article IV only such country shall be excluded from the Territory. The royalties for such country shall be calculated by aggregating the sales for all countries in Europe which have been excluded from the Territory under this Section 4.2.2 and applying the marginal royalty rates set out in Section 4.2.1 for such countries only, taking into account the reduction due pursuant to this Section 4.2.2 .
4.2.3. Royalty Reduction due to License of Third Party Intellectual Property .
(a) If, during the Term and after consultation with the Company, Nestlé and/or any of its Affiliates enters into an agreement with a Third Party in order to obtain a royalty bearing license under any Patent Right of a Third Party that, in Nestlés reasonable
judgment, would be necessary for Nestlé to Manufacture (to the extent permitted hereunder) or Commercialize HMPL-004 or such Product in the Field in the Territory, which Nestlé may only do in compliance with Section 4.2.3(b) (a New Third Party License ), then Nestlé will be entitled, on a Product-by-Product and country-by-country basis, to credit against any royalty payable to the Company under Section 4.2.1 [**] of any royalty (but no other payments) (the Company Portion ) actually paid by or on behalf of Nestlé and/or any of its Affiliates to such Third Party as a result; provided, however, that in no event will any royalty payable to the Company be reduced as a result of this Section 4.2.3 by more than [**] of the amount otherwise due to the Company over the same period. In addition, any such Company Portion will not reduce the amounts due to the Company under Section 4.2.1 in any Calendar Quarter by more than [**] of the amounts otherwise due. Any deductions of a Company Portion to which Nestlé is entitled under this Section 4.2.3 will be carried forward to the next Calendar Quarter until fully exhausted.
(b) Sublicensing of New Third Party Licenses. All New Third Party Licenses will be sublicensable to the Company so that the Company receives a grant to the Intellectual Property licensed under such New Third Party License for purposes of the Company conducting activities or potential activities permitted under this Agreement or another Governing Agreement and for performing obligations under this Agreement or another Governing Agreement.
4.3. Reports and Payments.
4.3.1. Royalty Reports . Within [**] days after the end of each Calendar Quarter beginning with the Calendar Quarter in which the First Commercial Sale of a Product is made in any jurisdiction in the Territory, Nestlé will deliver to the Company a report setting forth for the previous Calendar Quarter the following information on a Product-by-Product basis: (a) the Net Sales of each Product in each jurisdiction, (b) the number of units sold by Nestlé, its Affiliates or Sublicensees, (c) the basis for any adjustments to the royalty payable for the sale of each Product, (d) the royalty due hereunder for the sales of each Product, and (e) the applicable exchange rate as determined in accordance with this Agreement. The total royalty due for the sale of Products during such Calendar Quarter will be remitted at the time such report is made.
4.3.2. Taxes and Withholding .
(a) [**].
(b) [**].
(c) [**].
(d) [**].
(e) [**].
4.3.3. Currency . All amounts payable and calculations hereunder will be in US dollars. As applicable, Net Sales and any royalty deductions will be translated into US dollars in accordance with Nestlés customary and usual currency conversion procedures, consistently applied. If, due to restrictions or prohibitions imposed by national or international authority, payments cannot be made as provided in this Article IV , the Parties will consult with a view to finding a prompt and acceptable solution, and Nestlé will deal with such monies as the Company may lawfully direct at no additional out-of-pocket expense to Nestlé.
4.3.4. Method of Payment . Except as permitted pursuant to Section 4.3.3 , each payment hereunder will be made by electronic transfer in immediately available funds via a bank wire transfer, an automated clearing house (ACH) mechanism or any other means of electronic funds transfer, at Nestlés election, to the bank account designed by the Company in accordance with this Section 4.3 in writing to Nestlé at least [**] days before the payment is due.
4.3.5. Record Keeping . Nestlé will keep, and will cause its Affiliates and Sublicensees to keep, books and accounts of record in connection with the sale of Products, including records of gross invoiced sales, Net Sales, exchange rates and royalty payments (collectively, the Financial Records ), in accordance with the International Financial Reporting Standards in force from time to time (as appropriate) and in sufficient detail to permit accurate determination of all figures necessary for verification of royalties and other payments to be made by Nestlé under this Article IV . Nestlé and its Affiliates and Sublicensees will maintain such records for a period of at least three (3) years after the end of the Calendar Quarter in which they are generated.
4.3.6. Audits . Upon thirty (30) days prior written notice from the Company, Nestlé will permit, and will cause its Affiliates and Sublicensees to permit, an independent certified public accounting firm of internationally recognized standing selected by the Company and reasonably acceptable to Nestlé, to examine, at the Companys sole expense, the relevant Financial Records of Nestlé and its Affiliates and Sublicensees as may be reasonably necessary to verify the amounts reported by Nestlé in accordance with Section 4.3.1 and the royalties and other payments made by Nestlé in accordance with this Article IV . The Company will be entitled to conduct an audit in accordance with this Section 4.3.6 not more than once in any Calendar Year and not more than once in respect of the Financial Records from any Calendar Year and such audit will be limited to the pertinent Financial Records from any Calendar Year ending not more than three (3) years prior to the date of the request. The accounting firm will be provided access to such Financial Records at Nestlés facility(ies) where such Financial Records are normally kept and such audit will be conducted during Nestlés normal business hours. Upon completion of the audit, the accounting firm will provide both Parties with a written report disclosing any discrepancies in the reports submitted by Nestlé or payments made by Nestlé, if any, and in each case, the specific details concerning any discrepancies. Any information provided by Nestlé to the accounting firm and the written report of the accounting firm will be the Confidential Information of Nestlé.
4.3.7. Underpayments/Overpayments . If a report of an independent public accounting firm submitted to the Parties in accordance with Section 4.3.6 shows any underpayment of royalties and other payments due under this Article IV , Nestlé will remit to the Company within [**] days after receipt of such report by Nestlé, (a) the amount of such underpayment plus interest, calculated from the date such underpayment should have been originally made to the Company and (b) if such underpayment exceeds [**] of the total amount owed to the Company for the Calendar Year then being audited, the reasonable fees and expenses of such independent public accounting firm performing the audit, subject to reasonable substantiation thereof. If such independent public accounting firms written report shows any overpayment of royalties or other payments due under this Article IV, Nestlé will receive a credit equal to such overpayment plus interest, calculated from the date such overpayment was originally made to the Company hereunder against the royalties and other payments due under this Article IV otherwise payable to the Company.
4.3.8. Interest . Any payment under this Article IV that is more than [**] days past due or any credit under this Article IV will be subject to interest at an annual percentage rate of the twelve (12) month London Interbank Offered Rate plus [**] basis points if a Party does not make payment within [**] days of its receipt of notice that such amount is past due. Notwithstanding the preceding, if a Party contests any amounts due hereunder in good faith and promptly notifies the other Party of such dispute, interest will not accrue as to amounts being so contested until [**] days following the presentation of such notice to the other Party.
ARTICLE V
COVENANTS
5.1. Confidentiality.
5.1.1. Confidential Information . Each Party (the Receiving Party ) agrees to keep in strict confidence all Confidential Information that the other Party (the Disclosing Party ) provides, communicates or otherwise makes available to the Receiving Party and to protect the Confidential Information with the same degree of care normally used to protect its own Confidential Information of a similar nature. The Receiving Party will not disclose or allow disclosure of any Confidential Information to any Third Party and will not use any Confidential Information in any manner, except, in each case, for the purposes of implementing and enforcing this Agreement without the prior written consent of the Disclosing Party.
5.1.2. Exceptions to Confidentiality . The restrictions and obligations set forth in Sections 5.1.1 , 5.1.3 and 5.1.4 will not apply to any Confidential Information:
(a) which is or becomes generally available to the public through no fault on the part of the Receiving Party;
(b) which is lawfully in the possession of the Receiving Party (other than pursuant to the terms of this Agreement) without restriction as to its disclosure, prior to the disclosure of such information by or on behalf of the Disclosing Party or the Company, as reasonably evidenced by appropriate documentation;
(c) which lawfully becomes available to the Receiving Party from a source other than the Disclosing Party and the Company without any duty as to confidentiality or non-use;
(d) which is independently developed or otherwise created by the Receiving Party (other than pursuant to the terms of this Agreement) without the use of any Confidential Information of the Disclosing Party, as reasonably evidenced by appropriate documentation; or
(e) which is required to be disclosed or provided to any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) (i) pursuant to any Applicable Laws, judgment, decree or order; (ii) as necessary to make regulatory filings and communications related to HMPL-004 or any Products; or (iii) for the purpose of asserting or defending against any claims relating to Intellectual Property Rights, including, in particular, any action taken to protect and enforce Intellectual Property Rights; provided , however , that (x) any such information disclosed pursuant to this Section 5.1.2(e) will be disclosed only to the extent required by Applicable Laws, judgment, decree or order; (y) except with respect to required disclosure to tax authorities, the Party seeking to disclose or provide such information will give the other Parties prompt written notice of such requirement and fully cooperate with the other Parties so that the other Parties and/or the Company (as the case may be) may obtain reasonable assurances that confidential treatment will be accorded to
such information; and (z) without limiting the generality of the foregoing, the Parties will use Commercially Reasonable Efforts to ensure that, subject to Applicable Laws, the list of the Products is redacted from any copy of this Agreement required to be filed with any government or regulatory body.
5.1.3. Measures to Keep Confidentiality . Each Party agrees that, prior to giving access to any Confidential Information to any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, advisors, consultants and agents, it will require each such Person to agree to be bound by all obligations of confidentiality and non-use under this Section 5.1 , and will take all reasonable steps and measures to ensure that each such Person will enter into a confidentiality undertaking to comply with and perform such obligations, in each case to the same extent as if they were direct parties to this Agreement.
5.1.4. Survival of Obligations . The obligations undertaken by the Parties under this Section 5.1 will survive the termination of this Agreement for any reason and will remain in effect and be binding on the Parties for a period of ten (10) years after the termination of this Agreement.
5.1.5. Notification . The Receiving Party will notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing Party may reasonably request, upon the Receiving Partys discovery of any loss or compromise of the Disclosing Partys Confidential Information.
5.1.6. Destruction of Confidential Information . Upon the expiration or earlier termination of this Agreement, except with respect to Confidential Information necessary or useful for a Receiving Party to exercise any rights or perform any obligations under this Agreement surviving such expiration or termination, the Receiving Party will (a) destroy all tangible embodiments of Confidential Information of the Disclosing Party, including any and all copies thereof, and those portions of any documents, memoranda, notes, studies and analyses prepared by the Receiving Party or its Affiliates that contain, incorporate or are derived from such Confidential Information and provide written certification of such destruction to the Disclosing Party in a form reasonably acceptable to the Disclosing Party, provided that the legal department of the Receiving Party will have the right to retain one (1) copy of any such tangible embodiments for archival purposes, provided such copy will continue to be maintained on a confidential basis subject to the terms of this Agreement, and (b) immediately cease, and will cause its Affiliates to cease, use of such Confidential Information as well as any information or materials that contain, incorporate or are derived from such Confidential Information.
5.1.7. Use of Name and Disclosure of Terms . Each Party will keep the existence of, the terms of and the transactions covered by this Agreement confidential and will not disclose such information to any Third Party through a press release or otherwise, or mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other Party or its Affiliates in any manner without the prior written consent of the other Party in each instance (which will not be unreasonably withheld). The restrictions imposed by this Section 5.1.7 will not prohibit either Party from making any disclosure that is required by Applicable
Laws or the requirements of a national securities exchange or another similar regulatory body, including disclosing such information in any clinical trial database maintained by or on behalf of a Party, or that is expressly permitted under this Agreement. Further, the restrictions imposed on each Party under this Section 5.1.7 are not intended, and will not be construed, to prohibit a Party from identifying the other Party in its internal business communications, provided that any Confidential Information in such communications remains subject to this Section 5.1.7 .
5.1.8. Remedies . The Parties acknowledge and agree that the restrictions set forth in Article V are reasonable and necessary to protect the legitimate interests of the Parties and that neither Party would have entered into this Agreement in the absence of such restrictions, and that any breach or threatened breach of any provision of Article V will result in irreparable injury to the other Party for which there will be no adequate remedy at law. In the event of a breach or threatened breach of any provision of Article V by a Party, the other Party will be authorized and entitled to obtain from any court of competent jurisdiction injunctive relief, whether preliminary or permanent, specific performance and an equitable accounting of all earnings, profits and other benefits arising from such breach, which rights will be cumulative and in addition to any other rights or remedies to which such Party may be entitled in law or equity. The breaching Party agrees to waive any requirement that the non-breaching Party (a) post a bond or other security as a condition for obtaining any such relief and (b) show irreparable harm, balancing of harms, consideration of the public interest or inadequacy of monetary damages as a remedy. Nothing in this Section 5.1.8 is intended, or will be construed, to limit the Parties rights to equitable relief or any other remedy for a breach of any provision of this Agreement.
5.2. Compliance with Law.
5.2.1. General . Nestlé hereby covenants and agrees to comply with, and will cause its Affiliates to comply with, Applicable Laws related to the use and Commercialization of HMPL-004 and the Products. The Company hereby covenants and agrees to comply with, and will cause its Affiliates to comply with, Applicable Laws related to the use, Development and Manufacture of HMPL-004 and the Products. For the avoidance of doubt, nothing in this Agreement will require either Party to undertake any activity which violates, or which it believes, in good faith, may violate, any Applicable Laws.
5.2.2. Patient Information . Without limiting the generality of the foregoing, each Party agrees to abide, and will cause its Affiliates to abide, by all Applicable Laws concerning the confidentiality or protection of patient identifiable information or patients protected health information in the course of their performance under this Agreement.
5.2.3. Debarment . Each Party agrees that it will not knowingly use, and will cause its Affiliates to not knowingly use, in any capacity, in connection with any of its obligations to be performed under this Agreement any individual who has been disqualified or been charged with or convicted under Applicable Laws relating to the development or approval, or otherwise relating to the regulation of pharmaceutical products, food supplements or medical foods.
5.3. Anti-Corruption Laws.
5.3.1 Compliance with Anti-Corruption Law . In carrying out their responsibilities under this Agreement, the Parties will comply with all applicable anti-corruption laws in the countries where the Parties have their principal or other places of business and where they conduct activities under this Agreement. Additionally, the Parties understand and agree to comply with the US Foreign Corrupt Practices Act of 1977 ( US Act ) and the UK Bribery Act of 2010 ( UK Act ), in each case as revised,
which in the case of the US Act generally prohibits the promise, payment or giving of anything of value either directly or indirectly to any government official for the purpose of obtaining or retaining business or any improper advantage, and in the case of the UK Act includes the prohibition on the making of any bribe to a foreign public official with the intention of influencing such person in order to obtain or retain business or an advantage in the conduct of business. For purposes of this Section 5.3.1 , (a) government official means any official, officer, representative, or employee of, including any doctor employed by, any non-US government department, agency or instrumentality (including any government-owned or controlled commercial enterprise), or any official of a public international organization or political party or candidate for political office; and (b) foreign public official means an individual who holds a legislative, administrative or judicial position of any kind, whether appointed or elected, of a jurisdiction or territory outside the United Kingdom (or any subdivision of such a jurisdiction or territory); exercises a public function (i) for or on behalf of a jurisdiction or territory outside the United Kingdom (or any subdivision of such a jurisdiction or territory), or (ii) for any public agency or public enterprise of that jurisdiction or territory (or subdivision); or is an official or agent of a public international organization.
5.3.2. Certain Covenants regarding Anti-Corruption . Additionally, each Party undertakes that neither it nor any of its directors, employees, agents, consultants (or any other person who may be associated with a Party for the purposes of the UK Act) will directly or indirectly pay or give or promise to pay or give anything of value to any government official or a foreign public official for purposes of (a) influencing any act or decision of any such person in his official capacity; (b) inducing such person to do or omit to do any act in violation of the lawful duty of such official; (c) securing any improper advantage; or (d) inducing such person to use his position to affect or influence any act or decision of government or any legislative, administrative, public agency or other public body with respect to any activities undertaken relating to this Agreement. Additionally, the Parties will make reasonable efforts to comply with requests for information, including answering questionnaires and narrowly tailored audit inquiries, to enable the other Party to ensure compliance with any applicable anti-corruption laws.
5.3.3. Breach of Anti-Corruption Covenants . The Parties agree that a breach of the anti-corruption commitments in Section 5.3 will be considered a material breach of this Agreement and that either Party may immediately seek all remedies available under law and equity including termination of this Agreement pursuant to Section 8.3.1 if it believes, in good faith, that the covenants under the anti-corruption commitments in this Section 5.3 have been breached by the other Party, without owing to the other any damages or indemnification resulting solely from such termination.
ARTICLE VI
REPRESENTATIONS AND WARRANTIES
6.1. Representations and Warranties of Each Party. As of the Execution Date, each of Nestlé and the Company hereby represents and warrants to the other Party hereto as follows:
6.1.1. it is a corporation or entity duly organized and validly existing under the laws of the state or other jurisdiction of its incorporation or formation;
6.1.2. the execution, delivery and performance of this Agreement by such Party has been duly authorized by all requisite corporate action and does not require any shareholder action or approval;
6.1.3. it has the power and authority to execute and deliver this Agreement and to perform its obligations hereunder;
6.1.4. the execution, delivery and performance by such Party of this Agreement and its compliance with the terms and provisions does not and will not conflict with or result in a breach of any of the terms and provisions of or constitute a default under (i) a loan agreement, guaranty, financing agreement, agreement affecting a product or other agreement or instrument binding or affecting it or its property; (ii) the provisions of its charter or operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court or governmental authority entered against it or by which any of its property is bound;
6.1.5. it is not subject to, and the execution, delivery and performance by it of this Agreement will not subject it to, bankruptcy, insolvency, reorganization, moratorium or other similar laws affecting the enforcement of creditors rights generally and equitable principles of general application; and
6.1.6. it has the full right, power and authority to grant all of the right, title and interest in the licenses granted to the other Party under this Agreement.
6.2. Additional Representations and Warranties of the Company. Except as set forth in Schedule 6.2, the Company hereby represents and warrants to Nestlé that as of the Execution Date:
6.2.1. the Company, together with its Affiliates, is the sole and exclusive owner of, and has the sole right, title and interest in and to, Company Patent Rights and Company Know-How, in each case free and clear of any mortgage, pledge, claim, security interest, covenant, easement, encumbrance, lien, lease, sublease, option, or charge of any kind, limitations on transfer or any subordination arrangement in favor of a Third Party;
6.2.2. the Company Technology comprises all of the Intellectual Property rights forming HMPL-004 and all of the Intellectual Property rights used by the Company, its Affiliates, consultants and contractors in the Development and Commercialization of HMPL¬004 or any Products prior to the Execution Date;
6.2.3. all of the Company Patent Rights listed on Schedule 1.13 and the Key Patent Rights are in force or pending and have not been abandoned as of the Execution Date, and to the Companys knowledge, all such Company Patent Rights are valid and enforceable without any claims, challenges, oppositions, interference or other proceedings pending or threatened and the Company has filed and prosecuted patent applications within the Company Patent Rights in good faith and complied with all duties of disclosure with respect thereto and the Company has not initiated or been involved in any proceedings or claims in which it alleges that any Third Party is or was infringing or misappropriating any Company Technology, nor have any such proceedings been threatened by the Company, nor does the Company know of any valid basis for any such proceedings;
6.2.4. the Company has the right to use and disclose and to enable Nestlé to use and disclose (in each case under appropriate conditions of confidentiality) the Company Know-How free from encumbrances;
6.2.5. to the knowledge of the Company, the Development, Manufacturing and Commercialization of HMPL-004 and/or any Products in the Field in the Territory, in the form in which it is being Developed as of the Execution Date, does not infringe or misappropriate any Intellectual Property rights including the Patent Rights of a Third Party;
6.2.6. no Third Party has challenged or has threatened in writing to challenge the extent, validity or enforceability of the patents encompassed within the Company Technology relating to HMPL-004 or any Product (including, by way of example, through the institution or written threat of institution of interference, nullity or similar invalidity proceedings before a trademark or patent office or administration in any jurisdiction in the Territory), and all application, registration, maintenance and renewal fees in respect of Company Patent Rights have been paid and all documents and certificates required to be filed with the relevant agencies for the purpose of maintaining such Company Patent Rights have been filed;
6.2.7. there are no claims, judgments or settlements pending against the Company or its Affiliates with respect to any Company Technology, and the Company has not received notice that any such claims, judgments or settlements are threatened or of any infringement or misappropriation by the Company of the Intellectual Property rights including Patent Rights of a Third Party;
6.2.8. the Company has not granted any Third Party, including any academic organization or agency, any rights to the Company Technology, HMPL-004 or the Products, or any other rights that would otherwise interfere or be inconsistent with Nestlés rights hereunder, and there are no agreements or arrangements to which the Company or any of its Affiliates is a party relating to the Products, HMPL-004, the Company Patent Rights, or the Company Know-How that would limit the rights granted to Nestlé under this Agreement or that restrict or will result in a restriction on Nestlés ability to register, use or Commercialize HMPL-004 or the Products in the Territory;
6.2.9. no officer or employee of the Company is subject to any agreement with any other Third Party which requires such officer or employee to assign any interest in any Company Technology relating to HMPL-004 or any Products to any Third Party;
6.2.10. all of the Companys employees, officers, and consultants have executed agreements or have existing obligations under Applicable Laws requiring assignment to the Company of all inventions made during the course of and as the result of their association with the Company and obligating the individual to maintain as confidential the Companys Confidential Information as well as Confidential Information of other parties (including Nestlé and its Affiliates) which such individual may receive, to the extent required to support the Companys obligations under this Agreement and all inventions relevant to the rights granted to Nestlé under this Agreement have been duly transferred to the Company or its Affiliates in accordance with such agreements or existing obligations and Applicable Laws or the Company has entered into binding agreements permitting such a transfer;
6.2.11. the Company has taken all reasonable precautions to preserve the confidentiality of the Company Know-How and has not committed any act, or omitted to commit any act, that may cause the Company Patent Rights to expire prematurely or be declared invalid or unenforceable;
6.2.12. the Company has not entered into a government funding relationship that would result in rights to HMPL-004 or any Product residing with a Third Party, and the licenses granted hereunder are not subject to any overriding obligations to any government or other public entity.
6.2.13. neither the Company nor any employee, agent or subcontractor of the Company involved in the Development of HMPL-004 or the Products has been debarred, disqualified or charged with or convicted under Applicable Laws relating to the development or approval or otherwise relating to the regulation of pharmaceutical products, food supplements or medical foods; and
6.2.14. the Company is in compliance, and has at all times complied with, all Applicable Laws relating to the Company Technology, including Applicable Laws relating to export restrictions and controls and biodiversity (including the 1992 United Nations Convention on Biological Diversity and the 2011 Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization).
6.3. Repeating Representations and Warranties of the Company. As and when any Improvements are included in the Company Technology, the Company hereby represents and warrants to Nestlé that as at such date the warranties set out in Section 6.2 are true and accurate in respect of any such Improvements.
6.4. Separate and Independent Representations and Warranties. Each of the warranties and representations in Sections 6.1 and 6.2 will be separate and independent and (unless expressly provided otherwise) will not be limited by reference to any other warranty or by anything in this Agreement.
6.5. Representation by Legal Counsel. Each Party hereto represents that it has been represented by legal counsel in connection with this Agreement and acknowledges that it has participated in the drafting. In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption will exist or be implied against the Party which drafted such terms and provisions.
6.6. No Inconsistent Agreements. Neither Party has in effect and after the Execution Date neither Party will enter into any oral or written agreement or arrangement that would be inconsistent with its obligations under this Agreement or limit the ability of either Party to grant the licenses set forth in Article II of this Agreement.
6.7. Disclaimer. The foregoing warranties of each Party are in lieu of any other warranties, express or implied, including any implied warranties of non-infringement, any implied warranties of merchantability or any implied warranties of fitness for a particular purpose all of which are hereby specifically excluded and disclaimed. Each Party hereby disclaims any representation or warranty that the Development or Commercialization of HMPL-004 or any Product under this Agreement will be successful.
6.8. Covenants.
6.8.1. The Company covenants and agrees that for the Term in the Territory:
(a) it will not grant any interest or rights in the Company Technology, nor will the Company assign or encumber its right, title or interest in or to the Company Technology to any Third Party, in each case in a manner inconsistent with the rights granted to Nestlé under this Agreement, and will use all reasonable precautions to preserve the confidentiality of the Company Technology;
(b) it will not amend or modify the terms of any agreement under which it obtains rights to any of the Company Technology in a manner that may affect Nestlés rights under this Agreement without the prior written consent of Nestlé;
(c) the Company 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 Company Technology, 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; provided that the Company and its Affiliates will not be restricted pursuant to this Section 6.8.1(c) to the extent an act or failure to act does not affect Nestlés rights under this Agreement; and
(d) if, at any time after the execution of this Agreement, it becomes aware that it or any employee, agent or subcontractor of the Company who participated, or is participating, in the performance of any activities hereunder has been or is debarred, disqualified or charged with or convicted under Applicable Laws relating to the development or approval or otherwise relating to the regulation of pharmaceutical products, food supplements or medical foods, it will provide written notice of this to Nestlé within two (2) Business Days of it becoming aware of this fact.
ARTICLE VII
INTELLECTUAL PROPERTY
7.1. Ownership.
7.1.1. Ownership of Technology . Subject to the license grants under Article II of this Agreement, as between the Parties, the Company will own all Company Technology. Neither Party will take any action that would limit the other Partys right to exercise its rights under Section 2.4 . In the event inventorship and ownership of any Information or Patent Rights cannot be resolved by the Parties with advice of their respective Intellectual Property counsel, such dispute will be resolved through the dispute resolution mechanism set forth in Section 10.1 . For the avoidance of doubt, all Patent Rights, Information or other Intellectual Property Rights made or conceived during the Term solely by Nestlé (or its Affiliate) which is funded by Nestlé (or its Affiliate) will belong exclusively to Nestlé.
7.1.2. Employee Assignment . To the extent permissible under Applicable Laws, each Party will cause each employee and contractor conducting work on such Partys behalf under this Agreement to sign a contract that (a) compels prompt disclosure to the Party of all Company Technology, as applicable, conceived or reduced to practice by such employee or contractor during any performance under this Agreement, (b) automatically assigns to the Party all right, title and interest in and to all such Company Technology and all Patent Rights disclosing or claiming such Company Technology and (c) obligates such persons to similar obligations of confidentiality as set forth in this Agreement. Each Party will require each employee and contractor conducting work on such Partys behalf under this Agreement to maintain records in sufficient detail and in a good scientific manner appropriate for patent purposes to properly reflect all work done. Each Party will be responsible for the payment of any remuneration due to employees under any Applicable Laws that provides compensation to such employee inventors.
7.2. Filing, Prosecution and Maintenance of Patent Rights.
7.2.1. Company Patent Rights . The Company will be responsible, at its sole cost and expense, for the preparation, filing and prosecution, maintenance and defense of the Company Patent Rights in the Territory. The Company will keep Nestlé advised on the status of preparation, filing, prosecution, maintenance and defense of all patent applications included within Company Patent Rights and the maintenance of any issued patents within Company Patent Rights. Further, the Company will consult and reasonably cooperate with Nestlé with respect to the preparation, filing, prosecution, maintenance and defense of all Company Patent Rights, including: (a) allowing Nestlé a reasonable opportunity and reasonable time to review and comment regarding relevant material communications and drafts of any material responses or proposed filings by Nestlé before any applicable filings are submitted to any relevant patent office or Government Authority and (b) reflecting any reasonable comments offered by Nestlé in any final filings submitted by the Company to any relevant patent office or Government Authority.
7.2.2. Step-In Rights . If the Company does not file, prosecute or maintain any Patent Right as required by Section 7.2.1 , Nestlé may, if it is reasonable to do so to protect its interests, step-in and carry out such activity itself upon delivery of a notice to such effect to the Company. Upon delivery of such notice, Nestlé will have the right to file, prosecute and maintain such Patent Right at the Companys expense, and the Company will perform such acts as may be reasonably necessary for Nestlé to file, prosecute or maintain such Patent Right, at the Companys sole cost and expense. For the avoidance of doubt, any exercise by Nestlé of the right conferred by this Section 7.2.2 will be without prejudice to any rights or remedies available to Nestlé whether under this Agreement or otherwise.
7.2.3. Patent Term Extensions . The Parties will cooperate, if necessary and appropriate, with each other in gaining patent term extensions, including supplementary protection certificates and any other extensions that are available now or will become available in the future wherever applicable to Patent Rights that are applicable to HMPL-004 and/or the Products at the Companys cost. The Parties will, if necessary and appropriate, use reasonable efforts to agree upon a joint strategy relating to patent term extensions.
7.2.4. Orange Book Listing . Nestlé will, at the Companys expense and upon the Companys reasonable request, (a) provide all necessary or reasonably useful information to enable the Company to make filings with Regulatory Authorities with respect to Company Patent Rights as required by Regulatory Authorities in the Territory, and (b) will cooperate with the Company in connection therewith, including providing reasonable assistance for the Company in meeting any submission deadlines.
7.2.5. Costs and Expenses . Except as set forth in Section 7.2.2 , the Company will pay or reimburse Nestlé for all costs and expenses of filing, prosecuting, maintaining, defending and extending the Company Patent Rights.
7.3. Trademarks. The Company will select and own the Trademarks and all applications and registrations of Trademarks for the Products which have been Developed or for which the Company has obtained Regulatory Approval and will be solely responsible for applying for and maintaining the registrations for such Trademarks throughout the Territory, and all goodwill associated therewith will inure to the benefit of the Company. The Company will bear all costs of applying for and maintaining registrations for such Trademarks. The Company will assume full responsibility, at its sole cost and
expense, for prosecuting any infringement of any Company owned Trademark by a Third Party, and will be entitled to retain all recoveries in connection therewith.
7.4. Enforcement of Technology Rights.
7.4.1. Notice . Each Party will promptly notify the other in the event of any actual, potential or suspected infringement of a patent under the Company Patent Rights by any Third Party (an Infringement ).
7.4.2. Enforcement . If reasonably requested by Nestlé, the Company will institute litigation or take other steps to remedy an Infringement, and any such litigation or steps will be at the Companys reasonable expense. In order to establish standing, Nestlé, upon request of the Company, agrees to timely commence or to join in any such litigation, at the Companys reasonable expense, and in any event to cooperate with the Company in such litigation or steps at the Companys reasonable expense. Nestlé will have the right to consult with the Company about such litigation and to participate in and be represented by independent counsel in such litigation at Nestlés own expense, other than in respect of any reasonable fees incurred in respect of matters undertaken at the request of the Company where such fees will be at the Companys expense. If the Company fails to institute such litigation or otherwise take steps to remedy an Infringement of any Company Patent Right within [**] days of its receipt of notice thereof or if Nestlé elects to conduct such litigation itself, then Nestlé will (at its expense) have the right, but not the obligation, upon [**] days prior notice to the Company to institute any such litigation. Nestlé will have full control of such litigation or steps but will not, without the prior written consent of the Company, enter into any compromise or settlement relating to such litigation that (a) admits the invalidity or unenforceability of any Company Patent Right or (b) requires the Company to abandon any Company Patent Right. The Company will, at its own expense, cooperate with Nestlé in any such litigation. Any financial award granted in favor of Nestlé or the Company pursuant to an enforcement action under this Section 7.4.2 will be applied in priority to indemnify Nestlé (as licensee) for its losses and costs as a result of such decision and the excess will be shared between Nestlé and the Company in proportion to the amount spent by each Party in respect of such actions (including, without limitation, advisers fees and reasonable management time).
7.5. Third Party Claims.
7.5.1. Third Party Claims Course of Action . If the Development, Commercialization or Manufacture of HMPL-004 or the Product under this Agreement is alleged by a Third Party to infringe a Third Partys Patent Right(s) or misappropriate a Third Partys trade secret or has otherwise resulted in a claim in respect of product liability arising from or relating to HMPL-004 or a Product, the Party becoming aware of such allegation will promptly notify the other Party thereof, in writing, reasonably detailing the claim.
7.5.2. Third Party Suit . If a Third Party sues a Party (the Sued Party ) alleging that the Sued Partys or the Sued Partys Sublicensees Development, Manufacture or Commercialization of HMPL-004 or the Product infringes or will infringe said Third Partys Patent Right(s) or misappropriates said Third Partys trade secret or has otherwise resulted in a claim in respect of product liability arising from or relating to HMPL-004 or a Product, then at Nestlés option, the Company will defend or settle
such claim in its own name after consultation with Nestlé and in connection with its defense of any such Third Party suit, Nestlé will provide reasonable assistance to the Company for such defense and will join such suit if deemed a necessary party. The Company will keep Nestlé reasonably informed, in person or by telephone, prior to and during the pendency of any such suit, where Nestlé has not joined in such suit the information will be provided at minimum on a monthly basis. Where the Company will defend such claim, the Company will have full control of such litigation or steps but will not, without the prior written consent of Nestlé, such consent not to be unreasonably withheld, enter into any compromise or settlement relating to such litigation, including without limitation that (a) admits the invalidity or unenforceability of any Company Patent Right or any other Patent Right of Nestlé or its Affiliates or (b) requires the Company to abandon any Company Patent Right or requires Nestlé or its Affiliates to abandon any other Patent Right of Nestlé or its Affiliates (c) admits to any defect in HMPL¬004 or a Product which has, or could have contributed to, a product liability claim. Nestlé will, at its own expense, cooperate with the Company in any such litigation. Nestlé may however elect to defend or settle such claim on behalf of the Company in which case Nestlé will have full control of such litigation or steps and will defend or settle such claim in its own name and/or on behalf of the Company after consultation with the Company and in connection with its defense of any such Third Party suit, the Company will provide reasonable assistance to Nestlé for such defense and will join such suit if deemed a necessary party. Nestlé will keep the Company reasonably informed, in person or by telephone, prior to and during the pendency of any such suit, where the Company has not joined in such suit the information will be provided at minimum on a monthly basis. Where Nestlé will defend such claim, Nestlé will have full control of such litigation or steps but will not, without the prior written consent of the Company, such consent not to be unreasonably withheld, enter into any compromise or settlement relating to such litigation, including without limitation that (a) admits the invalidity or unenforceability of any Company Patent Right or (b) requires the Company to abandon any Company Patent Right (c) admits to any defect in HMPL-004 or a Product which has, or could have contributed to, a product liability claim. The Company will, at its own expense, cooperate with Nestlé in any such litigation.
7.6. Patent Certifications. Each Party will immediately give written notice to the other if it becomes aware that any Company Patent Rights covering a Product are invalid or that infringement will arise from the manufacture, use, import, sale or offer for sale of a Third Party product by a Third Party. If the Company decides not to bring infringement proceedings against the Third Party making such a claim with respect to any Product, the Company will give notice to Nestlé of its decision not to bring suit within [**] Business Days after receipt of notice of such claim (or, if the time period permitted by law is less than [**] Business Days, within half of the time period permitted by law for the Company to commence such action) and Nestlé may then, but will not be obligated to, bring suit against the Third Party that filed such claim. Any suit by either Party may be in the name of either or both Parties, as may be required by law. For this purpose, the Party not bringing suit will execute such legal papers necessary for the prosecution of such suit as may be reasonably requested by the Party bringing suit.
7.7. Privileged Communications. In furtherance of this Agreement, it is expected that Nestlé and the Company may, from time to time, disclose to one another privileged communications with counsel, including opinions, memoranda, letters and other written, electronic and verbal communications. Such disclosures are made with the understanding that they will remain confidential, they will not be deemed to waive any applicable attorney-client privilege and that they are made in connection with the shared community of legal interests existing between the Company and Nestlé, including the community of legal interests in avoiding infringement of any valid, enforceable patents of Third Parties and maintaining the validity of Company Patent Rights.
ARTICLE VIII
TERM AND TERMINATION
8.1. Term. The term of this Agreement will commence on the Execution Date and, unless earlier terminated as provided in this Article VIII will continue in full force and effect as long as any Product is being Commercialized pursuant to this Agreement for use in the Field in any jurisdiction within the Territory (the Term ).
8.2. Termination by Nestlé.
8.2.1. Termination for Convenience. If Nestlé reasonably determines, in good faith, that it is not feasible to pursue the Commercialization of HMPL-004 or the Products in any jurisdiction within the Territory due to scientific, technical, regulatory or commercial reasons, then Nestlé will notify the Company thereof and the Parties will meet and discuss how to proceed; provided that, if such determination is reasonably made by Nestlé in good faith, Nestlé will have the right to terminate this Agreement in its entirety upon ninety (90) days written notice.
8.2.2. Termination At Will. Nestlé may terminate this Agreement in its entirety, for any reason or for no reason, at any time upon giving written notice to the Company at least three hundred and sixty five (365) days prior to the effective date of such termination.
8.3. Termination for Cause.
8.3.1. Termination for Material Breach of this Agreement . In the event that a Party commits a material breach of its obligations under this Agreement that is not cured within sixty (60) days (or such other time period as mutually agreed by the Parties) after such Party receives written notice from the non-breaching Party, which notice will specify the nature of the breach and demand its cure, the non-breaching Party may terminate this Agreement upon written notice to the breaching Party. Notwithstanding the foregoing, if either Party is alleged to be in material breach and disputes such termination through the dispute resolution procedures set forth in this Agreement, then the other Partys right to cure any breach of this Agreement or to terminate this Agreement will be suspended for so long as such dispute resolution procedures are being pursued by the allegedly breaching Party in good faith and, if it is finally and conclusively determined that the allegedly breaching Party is in material breach, then the breaching Party will have no further right to cure such material breach.
8.3.2. Termination for Bankruptcy . If at any time during the Term, a Party ( Bankrupt Party ), any of its creditors or other eligible party (i) files or commences a proceeding for the liquidation, bankruptcy, receivership, reorganization, rehabilitation, composition, winding-up, dissolution or judicial management or administration of the Bankrupt Party or the appointment of a liquidator, judicial manager, receiver, administrator, trustee-in-bankruptcy or other similar officer in respect of that Party or its assets, and such proceeding has not been stayed or dismissed within ninety (90) days after the filing thereof, (ii) the Bankrupt Party is unable to pay or has suspended payment of its debt generally as they become due (except debts being contested in good faith), or (iii) the creditors of the Bankrupt Party have taken over
its management (whether pursuant to a receivership or otherwise), the other Party may terminate this Agreement at any time by written notice with immediate effect.
8.4. Effect of Termination.
8.4.1. General . Except as otherwise expressly provided herein, if this Agreement terminates for any reason, all rights and obligations of each Party will cease, including all rights and licenses granted by either Party to the other Party that do not expressly survive such termination.
8.4.2. Effects of Termination . If this Agreement is terminated by the Company pursuant to Section 8.3 or by Nestlé pursuant to Section 8.2 , the following provisions will apply:
(a) Nestlé will reasonably cooperate with the Company to assure a smooth transition, at the Companys expense, of any Clinical Trials in progress related to HMPL-004 or a Product in the Field in the Territory, which the Company determines to continue in compliance with Applicable Laws and ethical guidelines applicable to the transfer or termination of any such Clinical Trials. In the event that the Company informs Nestlé that it does not intend to continue specific Development activities then in progress, costs incurred in closing out such activities will be borne by Nestlé;
(b) Until termination is effective, each Party will continue to perform its obligations under this Agreement and will pay all costs allocated to it in accordance with this Agreement;
(c) The Right of Reference granted to Nestlé pursuant to Section 2.5.1 by the Company will survive termination of the Agreement except such Right of Reference will be solely to the extent necessary for Nestlé to obtain Regulatory Approval of any Product in the Field in any jurisdiction in which Nestlé has a valid license over HMPL¬004 and/or any Product; and
(d) Nestlé will for a period of [**] calendar months after the date of termination have the right to dispose of all stocks of Products in its possession and all Products in the course of manufacture at the date of termination and will pay to the Company any royalties due in accordance with the provisions of Section 4.2 within [**] days after the end of such period of [**] calendar months.
8.5. Survival of Certain Obligations. Expiration or termination of this Agreement will not relieve the Parties of any obligation accruing before such expiration or termination. The provisions of this Agreement that must, by their nature, survive expiration or termination of this Agreement to give effect to their intent, will so survive, including Section 5.1 ( Confidentiality ), Section 9.1 ( Indemnification by the Company ) and Section 9.2 ( Indemnification by Nestlé ).
ARTICLE IX
PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE
9.1. Indemnification by the Company. The Company will indemnify, defend and hold harmless Nestlé, its Affiliates, and each of its and their respective employees, officers, directors, agents and Sublicensees (each, a Nestlé Indemnified Party ) from and against, and covenants to pay on demand to a Nestlé Indemnified Party an amount equal to the aggregate of, all liabilities, obligations, judgments, liens, injunctions, charges, orders, decrees, rulings, damages, dues, assessments, taxes, losses, fines, penalties, expenses, fees, costs, amounts paid in settlement (including reasonable attorneys and expert witness fees and disbursements in connection with investigating, defending or settling any action
or threatened action), arising out of any claim, damages, complaint, demand, cause of action, audit, investigation, hearing, action, suit or other proceeding asserted or initiated (collectively, Liability ) that a Nestlé Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of:
9.1.1. any Company representation or warranty set forth herein being untrue in any material respect when made or any material breach by the Company of any of its covenants or obligations hereunder;
9.1.2. the gross negligence or willful misconduct by or of the Company, its Affiliates and their respective officers, directors, agents and Sublicensees in performing any of their obligations under this Agreement; or
9.1.3. the Development, Commercialization, Manufacture or other use of HMPL-004 or a Product by the Company, its Affiliates or Sublicensees (excluding Nestlé and its Affiliates and Sublicensees),
except in each case, to the extent caused by the gross negligence or willful misconduct of Nestlé or any Nestlé Indemnified Party, or by breach of this Agreement by Nestlé.
9.2. Indemnification by Nestlé. Nestlé will indemnify, defend and hold harmless the Company, its Affiliates, and each of its and their respective employees, officers, directors, agents and Sublicensees (each, a Company Indemnified Party ) from and against, and covenants to pay on demand to a Nestlé Indemnified Party an amount equal to the aggregate of all Liabilities that a Company Indemnified Party may be required to pay to one or more Third Parties to the extent resulting from or arising out of:
9.2.1. any Nestlé representation or warranty set forth herein being untrue in any material respect when made or a material breach by Nestlé of any of its covenants or obligations hereunder; or
9.2.2. the gross negligence or willful misconduct by or of Nestlé, its Affiliates and their respective officers, directors, agents and Sublicensees in performing any of their obligations under this Agreement; or
9.2.3. the Commercialization or other use of HMPL-004 or any Product by Nestlé, its Affiliates or Sublicensees;
except in each case, to the extent caused by the gross negligence or willful misconduct of the Company or any Company Indemnified Party, or by breach of this Agreement by the Company. For the avoidance of doubt, no claim will be made under this Section 9.2 in respect of any Liability in respect of which Nestlé has a claim against the Company pursuant to this Agreement.
9.3. Procedure. In respect of all claims under the indemnities which do not fall within Section 7.4 , Section 7.5 and/or Section 7.6 , the following provisions shall apply:
9.3.1. Each Party will notify the other in the event it becomes aware of a claim for which indemnification may be sought hereunder or for which Liability is shared pursuant to this Article IX . In case any proceeding (including any governmental investigation) will be instituted involving any
Party in respect of which indemnity may be sought pursuant to this Article IX, the Party benefitting from the rights under the indemnity (the Indemnified Party ) will provide the other Party (the Indemnifying Party ) with prompt written notice of such proceeding (the Indemnification Claim Notice ). Promptly after the Indemnifying Party receives the Indemnification Claim Notice, the Indemnifying Party and Indemnified Party will meet to discuss how to respond to any claims that are the subject matter of such proceeding.
9.3.2. Subject to the consent of the Indemnified Party, the Indemnifying Party may assume the defense of any Third Party claim subject to indemnification as provided for in this Section 9.3 by giving written notice to the Indemnified Party.
9.3.3. Upon assuming the defense of a Third Party claim in accordance with this Section 9.3 , the Indemnifying Party will be entitled to appoint lead counsel in the defense of the Third Party claim. Should the Indemnifying Party assume and continue the defense of a Third Party claim, except as otherwise set forth in this Section 9.3 , the Indemnifying Party will not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party claim, other than reasonable fees (including legal fees) incurred by the Indemnified Party in providing such assistance as requested by the Indemnifying Party.
9.3.4. Without limiting this Section 9.3 , any Indemnified Party will be entitled to participate in, but not control, the defense of a Third Party claim for which it has sought indemnification hereunder and to employ counsel of its choice for such purpose; provided, however, that such employment will be at the Indemnified Partys own expense unless (i) the employment thereof has been specifically authorized by the Indemnifying Party in writing, or (ii) the Indemnifying Party has failed to assume and actively further the defense and employ counsel in accordance with this Section 9.3 (in which case the Indemnified Party will control the defense). With respect to any Liabilities in connection with Third Party claims, where the Indemnifying Party has assumed the defense of the Third Party claim in accordance with this Section 9.3 , the Indemnifying Party will have authority to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Liability provided that: (i) it obtains the prior written consent of the Indemnified Party (which consent will be at the Indemnified Partys reasonable discretion), or (ii) the Liability relates solely to the payment of money damages in connection with a Third Party claim that will not result in the Indemnified Party or any of its Affiliates becoming subject to injunctive or other relief or otherwise adversely affect the business of the Indemnified Party or any of its Affiliates or Sublicensees in any manner, and the Indemnifying Party has first confirmed in writing its agreement to indemnify the Indemnified Party, its Affiliates and Sublicensees with respect to such Liability.
9.3.5. The Indemnifying Party that has assumed the defense of the Third Party claim in accordance with this Section 9.3 will not be liable for any settlement or other disposition of a Liability by an Indemnified Party (but in no event to include any court judgment or judicial or administrative order or disposition) that is reached without the written consent of such Indemnifying Party. To the extent permitted under Applicable Laws, the Indemnified Party will not admit any liability with respect to, or settle, compromise or discharge, any Third Party claim without first discussing with the Indemnifying Party the opportunity for the Indemnifying Party to assume the defense of the Third Party claim in accordance with this Section 9.3 . If the Indemnified Party consents to the Indemnifying Party assuming conduct of any Third Party claim, the Indemnified Party will cooperate in the conduct thereof and will 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 with
such Third Party claim. Such cooperation will include access during normal business hours afforded to 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 employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party will reimburse the Indemnified Party for all its reasonable out-of-pocket expenses incurred in connection with such cooperation.
9.4. Insurance. The Parties will maintain insurance with creditworthy insurance companies or self-insure in accordance with Applicable Laws against such risks and in such amounts as are usually maintained or insured against by other companies of established repute engaged in the same or a similar business.
ARTICLE X
MISCELLANEOUS
10.1. Governing Law, Jurisdiction; Dispute Resolution.
10.1.1. Governing Law . The interpretation and construction of this Agreement (including any non-contractual claims) will be governed by the laws of England and Wales.
10.1.2. Dispute Resolution . In the event of a dispute arising out of or relating to this Agreement, (including regarding its existence, termination or validity) (a Dispute ) any Party will provide written notice of the Dispute to the other Parties, in which event the Dispute will be referred to the executive officers of the Parties designated below or their successors. The designated officers will use reasonable efforts to attempt resolution by good faith negotiations within [**] days after such notice is received. Said designated officers are initially as follows:
For the Company: The General Manager and Finance Director
For Nestlé: President and Chief Executive Officer
In the event the designated executive officers do not resolve such Dispute within the allotted [**] days, any Party may, after the expiration of the [**] day period, seek to resolve the Dispute through reference to arbitration in accordance with Section 10.1.3 . Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, will not be deemed a Dispute which may be referred for resolution by the Parties under this Section 10.1.2 .
10.1.3. Arbitration . All Disputes which are unresolved pursuant to Section 10.1.2 and which a Party wishes to have resolved will be referred upon the application of any Party to, and finally settled by, arbitration in accordance with the ICC Arbitration Rules (the Rules ) as in force at the date of this Agreement and as modified by this Section 10.1.3 , which Rules are deemed incorporated into this Section 10.1.3 . The number of arbitrators will be three (3), one of whom will be appointed by each Party and the third of whom, who will act as chairman, will be nominated by the two party-nominated arbitrators, provided that if the third arbitrator has not been nominated within twenty (20) Business Days of the nomination of the second party-nominated arbitrator, such third arbitrator will be appointed by the ICC. The seat of arbitration will be London and the language of arbitration will be English.
The arbitrators will have the power to grant any legal or equitable remedy or relief available under law, including injunctive relief (whether interim and/or final) and specific performance, and any measures ordered by the arbitrators may be specifically enforced by any court of competent jurisdiction. Each Party retains the right to seek interim or provisional measures, including injunctive relief and including pre-arbitral attachments or injunctions, from any court of competent jurisdiction and any such request will not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate. For the avoidance of doubt, this Section 10.1.3 is not intended to limit the powers of the court exercisable in support of arbitration proceedings pursuant to Section 44 of the Arbitration Act 1996 or any Applicable Laws.
10.2. Force Majeure. No liability will result from, and no right to terminate will arise, in whole or in part, based upon any delay in performance or non-performance, in whole or in part, by either of the Parties to this Agreement to the extent that such delay or non-performance is caused by an event of Force Majeure. Force Majeure means an event that is beyond a non-performing Partys control, including an act of God, strike, lock-out or other industrial/labor dispute not involving the non-performing Partys (or its Affiliates) own employees, war, riot, terrorist act, epidemic, quarantine, fire, flood or natural disaster. The Force Majeure Party will within ten (10) days of the occurrence of the Force Majeure event, give written notice to the other Party stating the nature of the Force Majeure event, its anticipated duration and any action being taken to avoid or minimize its effect. Any suspension of performance will be of no greater scope and of no longer duration than is reasonably required and the Force Majeure Party will use reasonable effort to remedy its inability to perform; provided, however, if the suspension of performance continues or is anticipated to continue for thirty (30) days after the date of the occurrence, the unaffected Party will have the right but not the obligation to perform on behalf of the Force Majeure Party for a period of such Force Majeure and such additional period as may be reasonably required to assure a smooth and uninterrupted transition of such activities. If such failure to perform would constitute a material breach of this Agreement in the absence of such event of Force Majeure, and continues for [**] months from the date of the occurrence and the Parties are not able to agree on appropriate amendments within such period, the unaffected Party will have the right, notwithstanding the first sentence of this Section 10.2 , to terminate this Agreement immediately by written notice to the Force Majeure Party, in which case neither Party will have any liability to the other except for those rights and liabilities that accrued prior to the date of termination.
10.3. Waiver and Non-Exclusion of Remedies. A Partys failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy will 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
10.4. Notices.
10.4.1. Notice Requirements . Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in Section 10.4.2 or to such other address as the Party to whom notice is to be given may have provided to the other Parties in accordance with this Section 10.4.1 . Such Notice will be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second (2) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 10.4 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.
10.4.2. Address for Notice .
The Company:
Nutrition Science Partners Limited
22nd Floor, Hutchison House
10 Harcourt Road, Hong Kong
Attn: General Manager
Fax: +852 2128 1778
With a copy to:
The Finance Director
c/o Nestlé Health Science S.A.
Avenue Nestlé 55, 1800
Vevey Switzerland
Attn: General Counsel
Nestlé:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: President and Chief Executive Officer
With a copy to:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: General Counsel
10.5. Entire Agreement. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter hereof. All Schedules 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 and this Agreement, the terms of this Agreement will govern.
10.6. Amendment. Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of all Parties.
10.7. Assignability. This Agreement and each and every covenant, term and condition hereof will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Neither this Agreement nor any rights or obligations hereunder may be assigned, delegated or transferred, directly or indirectly, by a Party to any Third Party without the prior written consent of the other Party except that Nestlé may assign this Agreement and any rights hereunder to any of its Affiliates. Any attempted assignment or delegation in violation of this Section 10.7 will be void.
10.8. No Benefit to Others. The provisions of this Agreement are for the sole benefit of the Parties and their Affiliates, successors and permitted assigns, and they will not be construed as conferring any rights in any other Persons except as otherwise expressly provided in this Agreement. A Person who is not a party to this Agreement will have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of its terms.
10.9. Counterparts. This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which taken together will be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission will be as effective as an original executed signature page.
10.10. Severability. To the fullest extent permitted by Applicable Laws, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and will not form part of this Agreement. To the fullest extent permitted by Applicable Laws and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement will remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Laws and achieves, as nearly as possible, the original intention of the Parties.
10.11. Further Assurance. Each Party will perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
10.12. Publicity. The Parties agree to consult with each other reasonably and in good faith with respect to the text and timing of any subsequent press releases relating to the Agreement or the activity hereunder prior to the issuance thereof, provided that a Party may not unreasonably withhold consent to such releases, and that any Party may issue such press releases as it determines, based on advice of counsel, are reasonably necessary to comply with Applicable Laws, judgments, decrees, orders or for appropriate market disclosure or which are consistent with information disclosed in prior releases properly made hereunder.
10.13. Relationship of the Parties. The status of a Party under this Agreement will be that of an independent contractor. Nothing contained in this Agreement will 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 or any of its Affiliates will be employees of such Party or its Affiliates and not of the other Party or such other Partys Affiliates and all costs and obligations incurred by reason of any such employment will be for the account and expense of such Party or its Affiliates, as applicable.
10.14. 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 in the event of any conflict in interpretation between the English version and such translation, the English version will prevail. English will be the official language of this Agreement and all communications between the Parties will be conducted in that language.
10.15. Construction. Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word or has the inclusive meaning represented by the phrase and/or. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Schedules or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms including, include(s), such as, and for example as used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by without limitation.
[Signature Page Follows]
IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed and intend to and hereby do deliver this Agreement as a deed to be effective as of the Execution Date.
SEALED with the COMMON SEAL of |
[Signature of Christian Hogg] |
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SIGNATURE PAGE TO EUROPE LICENSE AGREEMENT
Schedule 1.13
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[Validity of patents and inclusion of any additional Company Patent Rights to be confirmed by the Parties at the time of execution.]
Appendix A
Option Exercise Notice
To: Nutrition Science Partners Limited (the Company )
Date: [ · ]
EXERCISE NOTICE
1. We refer to the option agreement dated [ · ] between Nestlé Health Science S.A. ( Nestlé ) and the Company (the Option Agreement ).
2. Terms defined in the Option Agreement will have the same meanings in this Exercise Notice unless the context requires otherwise. References to a Section are to a section of the Option Agreement.
3. We hereby give you notice under and pursuant to Section [2.1.2/2.1.3/2.2.2/2.3.2] of the Option Agreement that we hereby exercise the [US/Canada Option/Europe Option/ROW Country Option] in respect of [ insert countries in respect of which ROW Country Option being exercised ] granted by you to Nestlé under Section [2.1 ( US and Canada Option )/ 2.2 ( Europe Option )/ 2.3 ( ROW Country Option )] in respect of the [US/Canada License/Europe License/ROW License].
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Appendix B
Independent Expert Appointment Procedure
1. If the Parties fail to agree upon an independent Third Party expert within fifteen (15) Business Days of either Party providing written notice to the other notifying of a requirement to appoint an independent Third Party expert pursuant to the terms of the Agreement, either Party may refer the matter to ICC in London for determination in accordance with the ICC Rules of Expertise.
2. The determination made by the expert pursuant to the ICC Rules of Expertise will be final and binding upon the Parties. The language to be used in the expert determination will be English.
EXHIBIT C
SERVICES AGREEMENT
BY AND BETWEEN
和记黄埔医药 ( 上海 ) 有限公司 HUTCHISON MEDIPHARMA LIMITED
AND
NUTRITION SCIENCE PARTNERS LIMITED
[DATE]
TABLE OF CONTENTS
ARTICLE 1. INTERPRETATION |
210 |
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ARTICLE 2. SERVICE SCHEDULES |
211 |
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ARTICLE 3. SERVICES |
212 |
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ARTICLE 4. PROJECT MANAGEMENT AND INFORMATION SHARING |
213 |
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ARTICLE 5. COMPENSATION |
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ARTICLE 6. TAXES AND WITHHOLDING |
215 |
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ARTICLE 7. GENERAL OBLIGATIONS; STANDARD OF CARE |
216 |
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ARTICLE 8. TERM AND TERMINATION |
217 |
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ARTICLE 9. RELATIONSHIP BETWEEN THE PARTIES |
218 |
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ARTICLE 10. CONFIDENTIALITY |
219 |
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ARTICLE 11. INTELLECTUAL PROPERTY RIGHTS |
221 |
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ARTICLE 12. LIABILITY AND INDEMNIFICATION |
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ARTICLE 13. MISCELLANEOUS |
223 |
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ARTICLE 14. DEFINITIONS |
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Appendices |
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Appendix 1 |
Services Schedules |
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SERVICES AGREEMENT
This Services Agreement (the Agreement) is made and entered into as of [ · ] (the Effective Date ), by and among 和记黄埔医药 ( 上海 ) 有限公司 Hutchison MediPharma Limited, a limited company incorporated under the laws of the Peoples Republic of China ( Hutchison ) and Nutrition Science Partners Limited, a limited company incorporated under the laws of Hong Kong (the Company ).
RECITALS
WHEREAS, Hutchison MediPharma (Hong Kong) Limited, an Affiliate of Hutchison ( HMPHK ), the Company, Hutchison China MediTech Limited and Nestlé Health Science S.A., a company organized and existing under the laws of Switzerland ( Nestlé ) have entered into a Joint Venture Agreement on [ · ] November 2012 (the Joint Venture Agreement ) memorializing their mutual agreements and understandings on the establishment, financing, operation and management of the Company and their respective rights and obligations relative thereto.
WHEREAS, in connection with the Company and the development and manufacture of Products in the Field as further described in the Joint Venture Agreement, Hutchison will provide the Company with certain services which are described in Appendix 1 attached to this Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises herein made, and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
ARTICLE 1.
INTERPRETATION
Unless otherwise required by the context or unless otherwise specified herein, (a) the singular includes the plural, the plural includes the singular, (b) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (c) the word or has the inclusive meaning represented by the phrase and/or, (d) the words include, includes and including and such as, and for example will be deemed to be followed by the phrase without limitation, (e) whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days, (f) the word will will be construed to have the same meaning and effect as the word shall, (g) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein), (h) any reference herein to any Person will be construed to include the Persons successors and assigns, (i) the words herein, hereof and hereunder, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (j) all references herein to Articles, Sections or Appendices will be construed to refer to Articles, Sections or Appendices of this Agreement, and references to this Agreement include all Appendices hereto, (k) the word notice will mean notice in writing
(whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (l) provisions that require that a Party, the Parties or any committee hereunder agree, consent or approve or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging), and (m) references to any specific law, rule or regulation, or article, section or other division thereof, will be deemed to include the then- current amendments thereto or any replacement or successor law, rule or regulation thereof.
ARTICLE 2.
SERVICE SCHEDULES
2.1. SERVICE SCHEDULES GENERALLY. This Agreement will govern the delivery of Services provided by Hutchison. Hutchison will use commercially reasonable efforts to provide the Services according to the Service Schedules in force at the relevant time, with the initial agreed upon version of such Service Schedules attached to and made part of this Agreement as Appendix 1 .
2.2. INCONSISTENCIES. If there is any inconsistency between the terms of any Service Schedule and the terms of this Agreement, the terms of this Agreement will prevail.
2.3. SCOPE OF SERVICE SCHEDULES. The Service Schedules outline the Services to be conducted by Hutchison pursuant to this Agreement (as such may be amended pursuant to this Section 2.3 and Section 2.4 ). Each Service Schedule and each amendment thereto, will include a detailed list of tasks to be performed by Hutchison, a timeline for the performance of each task and FTE resource allocation. Each Service Schedule will also contain the Services Budget for the provision of such Services.
2.4. CHANGES TO SERVICE SCHEDULES. Changes to any of the Service Schedules, including but not limited to changes to the Services Budget, will be mutually agreed between the Parties; provided, however, that Hutchison will not unreasonably withhold, delay or condition its consent to changes proposed by the Company in good faith to any Service Schedule. For clarity, it being understood that Hutchison may reasonably withhold its consent to any such change proposed by the Company if it believes in good faith that the proposed change to the Service Schedule will require the effort of more FTEs than in the then current Service Schedule unless the Company agrees to pay the additional cost for such additional FTEs.
2.5. DOCUMENT RETENTION. Hutchison will maintain, in accordance with its standard document retention procedures, documentation supporting the charges contained in the Services Schedules, and all costs and expenses incurred by Hutchison and charged to the Company, and will cooperate with the Company in making such documentation and information available as needed.
ARTICLE 3.
SERVICES
3.1. SERVICES GENERALLY. Except as otherwise provided herein or in the applicable Service Schedule, during the Term, Hutchison will provide to the Company (i) the Services described in the Service Schedules and (ii) such additional Services as reasonably requested by the Company in writing and agreed to by Hutchison, such agreement not to be unreasonably withheld or delayed; provided that the Parties will amend the Service Schedules as necessary, to reflect such mutually agreed additional Services and that the Company will pay compensation for such additional Services in accordance with ARTICLE 5 hereof; and (b) use commercially reasonable efforts to achieve the Development milestones for which it is responsible under the Service Schedules. The Company acknowledges that due to the nature of the Services to be provided hereunder and the timelines set forth in the Services Schedules, Hutchison is unable to guarantee that such milestones and targets will be achieved, despite the use of commercially reasonable efforts.
3.2. IMPRACTICABILITY. Hutchison will not be required to provide any Service to the extent the performance of such Service becomes Impracticable. Should Hutchison determine that the performance of any Service has become Impracticable it will immediately so notify the Company in writing, specifying in reasonable detail (i) the event or circumstance that has rendered the provision of such Service Impracticable, (ii) the scope and extent of such Service affected thereby, (iii) the expected duration of such event or circumstance and (iv) the measures that Hutchison proposes to undertake to avoid or minimize the effect of such event or circumstance on its ability to perform such Service hereunder. Hutchison will, as promptly as reasonably practicable, resume performing such Service once the performance of the relevant Service is no longer Impracticable. The Parties will negotiate in good faith any reduction that either Party reasonably believes should be made to the compensation for the Services under ARTICLE 5 as a result of any Impracticability.
3.3. ADDITIONAL RESOURCES. Hutchison will obtain the resources necessary to perform the Services as provided in the applicable Service Schedules. For clarity, unless the Parties otherwise agree in writing, Hutchison will not be obligated to obtain additional resources not contemplated by the Service Schedules, including (i) hiring, leasing or contracting for any additional employees; (ii) maintaining the employment of any specific employee; or (iii) purchasing, leasing or licensing any additional equipment or software.
3.4. LICENSE. Subject to the terms and conditions of this Agreement, the Company hereby grants to Hutchison and its Affiliates during the Term a fully-paid up, non-transferable, non-exclusive license, with the right to sublicense solely to Third Parties acting on Hutchisons behalf in the performance of Hutchisons obligations under this Agreement, under the Company Technology to the extent necessary for Hutchison and its Affiliates to exercise their rights and perform their obligations under this Agreement.
ARTICLE 4.
PROJECT MANAGEMENT AND INFORMATION SHARING
4.1. PROJECT MANAGER. The Company will assign a project manager, who will be responsible for overseeing the day-to-day provision of Services hereunder to ensure that Services are provided, and Development proceeds, according to the Service Schedules. Within [**] days of the end of each Calendar Quarter during the Term, Hutchison will provide to the Company a summary of the Services provided by Hutchison in such most recently ended Calendar Quarter.
ARTICLE 5.
COMPENSATION
5.1. COMPENSATION FOR MATERIALS AND THIRD PARTY COSTS. The Company will reimburse Hutchison for all reasonable, out-of-pocket costs incurred by Hutchison for supplies and materials, as well as for all costs reasonably incurred by Hutchison to any Third Party, used in connection with providing the Services (the Materials and Third Party Costs ) provided that such Materials and Third Party Costs are within the then applicable Services Budget. Such costs will include all property taxes, VAT, customs and duties (except to the extent such taxes, customs or duties are recoverable by or refundable to Hutchison) levied on, as well as all other reasonable, out-of-pocket expenses associated with the purchase, use, transportation and insurance of, such supplies and materials.
5.2. COMPENSATION FOR SERVICES.
(a) Reimbursement for Services . In consideration of the performance of the Services by Hutchison, the Company will reimburse Hutchison for actual time spent by Hutchison personnel performing the Services under the Service Schedules on the basis of the number of FTEs performing activities under the Services Schedules and all reasonable out-of-pocket costs incurred by Hutchison in performing such Services.
(b) Limitations on Reimbursement and Compensation . Notwithstanding anything herein to the contrary, the Company will not be obligated to reimburse Hutchison for costs of Services (including reimbursement of Materials and Third Party Costs pursuant to Section 5.1 ) to the extent that such reimbursement exceeds such costs as set forth in the Services Budget contemplated by the Service Schedule by more than [**], unless such excess is approved by the Board.
5.3. PAYMENT TERMS.
(a) Invoices . Within [**] days after the end of each Calendar Quarter, Hutchison will provide a quarterly invoice to the Company detailing all charges for supplies, materials, and the number of FTEs
performing Services during the most recently concluded Calendar Quarter pursuant to this Agreement. With each such invoice, Hutchison will inform the Company in reasonable detail of the Services performed during the period covered by such invoice and the costs, fees and charges to be included in such invoice. Hutchison will also provide the Company with such supporting records and other materials as may be reasonably requested by the Company to review and verify the Services performed during such invoice period and the accuracy of the calculation of such costs, fees and charges. Payment will be remitted within [**] from the date such invoice is received by the Company.
(b) Payment . Any payment under this ARTICLE 5 that is more than [**] days past due will be subject to interest at an annual percentage rate of twelve (12) month London Interbank Offered Rate plus [**].
5.4. CORRECTION; TRUE-UPS; ACCOUNTING.
(a) Accounting Record Retention . Hutchison will, and will cause its Affiliates and Subcontractors to, keep and maintain complete and accurate books and records of the Services performed hereunder and the FTEs performing such Services for three (3) years after the close of the Calendar Quarter in which the relevant costs, fees and/or charges are incurred or assessed. These books and records will be kept in detail sufficient to allow for all costs, fees, and charges incurred or assessed for all Services to be properly verified and calculated.
(b) Audit . Upon thirty (30) days prior written notice from the Company, but not more than once annually, Hutchison will permit an independent certified public accounting firm of internationally recognized standing selected by the Company and approved by Hutchison, such approval not to be unreasonably withheld, delayed or conditioned, to examine, audit and copy, at the Companys sole expense, the relevant books and records of Hutchison and its Affiliates and Subcontractors reasonably related to the provision of any Services under this Agreement for the sole purpose of verifying the amounts invoiced by Hutchison hereunder. The accounting firm will be provided reasonable access to such books and records at the facility(ies) of Hutchison and/or its Affiliates and Subcontractors where such books and records are normally kept and such examination will be conducted during the normal business hours of Hutchison and/or its Affiliates and Subcontractors. Hutchison may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to such facilities or books and records. Upon completion of the audit, the accounting firm will provide both Hutchison and the Company a written report disclosing any discrepancies in the quarterly invoices submitted or the reimbursements paid by the Company, and, in each case, the specific details concerning any discrepancies.
(c) Dispute . Any good faith Invoice Dispute will be immediately subject to the provisions of this Section 5.4(c) . The Parties agree that disputes related to any other agreement will not serve as grounds to delay any performance of Services or payment obligations under this Agreement.
(i) The Parties will negotiate in good faith to resolve, pursuant to the procedures described in Section 5.4(c)(ii) , any Invoice Dispute. Notwithstanding the foregoing, either Party may seek preliminary or emergency injunctive relief in relation to an Invoice Dispute so as to maintain the status quo (including, but not limited to, maintaining the confidentiality of any non-public information) without or prior to initiating negotiations with the other Party until the Invoice Dispute is otherwise resolved.
(ii) Either Party may give the other Party a Notice of Invoice Dispute. Within ten (10) Business Days after delivery of such Notice of Invoice Dispute, executives of each Party who have authority to settle the Invoice Dispute will participate in conference or video calls or agree to meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, consult and negotiate with each other in good faith and, recognizing their mutual interests, attempt to reach a just and equitable solution satisfactory to the Parties. If the Invoice Dispute has not been resolved within [**] days of the first meeting of such executives (or, if the Parties are unable to mutually agree upon an acceptable time and place to meet, within [**] days of the disputing Partys Notice of Invoice Dispute), either Party may issue an Invoice Dispute Escalation Notice and refer the Invoice Dispute to the respective officers of the Parties designated below.
For Hutchison: The Chief Executive Officer
For the Company: The General Manager and the Finance Director
Such officers will negotiate in good faith to resolve the Invoice Dispute in a manner satisfactory to the Parties within [**] days of the Invoice Dispute Escalation Notice. In the event the Invoice Dispute is not resolved within such [**] day period, either Party may proceed with arbitration in accordance with Section 13.9 .
ARTICLE 6.
TAXES AND WITHHOLDING
6.1. TAXES AND WITHHOLDING. [**]
ARTICLE 7.
GENERAL OBLIGATIONS; STANDARD OF CARE
7.1. PERFORMANCE BY HUTCHISON. Subject to Section 3.2 and Section 3.3 , and the other terms and conditions of this Agreement, Hutchison will commit personnel to the timely performance of Services under the Service Schedule, in compliance with Applicable Laws.
7.2. GENERAL WARRANTIES. Each Party warrants and covenants to the other that (a) it has the full power and authority to enter into and fully perform this Agreement, (b) it has sufficient right and authority to grant all licenses and rights granted or agreed to be granted by it hereunder to the other Parties, and (c) at all times, it will comply with all Applicable Laws.
7.3. WARRANTIES. Hutchison warrants to the Company that as of the Effective Date all (i) Services provided hereunder will be in accordance with the terms of this Agreement, and (ii) personnel involved with the provision of the Services are subject to contractual undertakings to assign any Intellectual Property created in the course of such Services to the Company. Hutchison does not make any other warranties with respect to the Services provided by it hereunder.
7.4. PERFORMANCE BY THE COMPANY. Subject to the other terms and conditions of this Agreement, the Company will use its commercially reasonable efforts to coordinate with Hutchison for the timely performance of Services by Hutchison under the Service Schedule, in compliance with Applicable Laws. Hutchison may change its policies, procedures and practices at any time upon reasonable prior notice to the Company; provided, however, that such changes, if not required by Applicable Laws, do not affect the provision of Services hereunder; and provided, further, that the compensation due by the Company to Hutchison as a result of such changes will not be increased.
7.5. MUTUAL RESPONSIBILITIES. In addition to the terms provided in Sections 7.1 and 7.4 , the Parties will use good faith efforts to cooperate with each other in all matters relating to the provision and receipt of the Services. Such cooperation will include:
(a) providing and exchanging information and documentation reasonably necessary for Hutchison to perform the Services it is obligated to provide hereunder;
(b) making available, as reasonably requested by either Party, reasonable access to resources and providing timely decisions in order that each Party may perform its obligations hereunder;
(c) requiring each Partys personnel to obey any and all security regulations and other published policies of the other Party while on the other Partys premises; and
(d) using commercially reasonable efforts to obtain all Third Party consents, licenses, sublicenses or approvals necessary to permit Hutchison to perform its obligations hereunder.
ARTICLE 8.
TERM AND TERMINATION
8.1. TERM. This Agreement will continue until the expiration of the Term unless earlier terminated in accordance with this ARTICLE 8 . The Term of this Agreement may be extended by Hutchison and the Company in writing.
8.2. TERMINATION.
(a) Termination for Convenience .
(i) Termination of Services . The Company may terminate this Agreement, for any reason or for no reason, at any time upon giving written notice to Hutchison at least ninety (90) days prior to the Effective Date of such termination.
(ii) Payment of Costs Associated with Company Termination . If the Company terminates this Agreement under this Section 8.2(a) (where the Company does not have the right to terminate this Agreement pursuant to Section 8.2(b) or 8.2(c) below), the Company will pay to Hutchison all non- cancellable costs incurred pursuant to the Services Budget imposed by Third Parties as a result of such termination. Hutchison will inform the Company of such costs upon receipt of the termination notice and will undertake commercially reasonable efforts to mitigate such Third Party costs to the extent possible.
(b) Termination upon Material Breach . Notwithstanding the foregoing, a Party may terminate this Agreement if the other Party materially breaches a material provision of this Agreement and such material breach is not cured (i) within thirty (30) days after being given notice of the breach in the case of a material breach of an obligation to make payment hereunder or (ii) within sixty (60) days after being given notice of the breach in the case of any other material breach.
(c) Immediate Right to Terminate . A Party may immediately terminate this Agreement upon written notice to the other Party if, at any time during the Term, (i) the other Party files for or is subject to the institution of bankruptcy, reorganization, liquidation or receivership proceedings, (ii) the other Party assigns all or a substantial portion of its assets for the benefit of creditors, (iii) a receiver or custodian is appointed for the other Partys business, (iv) a substantial portion of the other Partys business is subject to attachment or execution
process based on a final, non-appealable court judgment or order or arbitral award, or (v) the Joint Venture Agreement has terminated; provided, however, that in the case of any involuntary bankruptcy, reorganization, liquidation or receivership proceeding under clause (i) above, no right of termination will arise unless and until such proceeding remains undismissed for at least ninety (90) days after the commencement thereof.
8.3. SURVIVING PROVISIONS. The obligations of the Parties under this Agreement will survive the expiration or termination of this Agreement to the extent necessary to carry out the purposes of this Agreement, including without limitation, payment obligations under ARTICLE 5 , confidentiality obligations under ARTICLE 10 , liabilities and indemnification obligations under ARTICLE 12 and applicable miscellaneous provisions under ARTICLE 13 .
ARTICLE 9.
RELATIONSHIP BETWEEN THE PARTIES
9.1. INDEPENDENT CONTRACTORS. The relationship between the Parties established under this Agreement is that of independent contractors and no Party is an employee, agent, partner, or joint venturer of or with another. Neither Party will have any express or implied power or authority to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever. Hutchison will be solely responsible for any and all salaries and other compensation, employment-related taxes, insurance premiums and other employment benefits respecting its personnel and the personnel of its Affiliates and Subcontractors engaged to perform Services under this Agreement. The Company agrees to grant Hutchison personnel reasonable access to its sites, systems and information (subject to the provisions of confidentiality in ARTICLE 10 below) as necessary for Hutchison to perform its obligations hereunder.
9.2. SUBCONTRACTORS. Hutchison may engage Subcontractors to perform all or any portion of Hutchisons obligations under this Agreement with the prior written approval of the Company, such approval not to be unreasonably withheld or delayed. Any such Subcontractor will, prior to being engaged to perform any activities hereunder, agree in writing to be bound by confidentiality obligations at least as protective as the terms of ARTICLE 10 regarding confidentiality below; and provided, further, that Hutchison will remain responsible for full performance of its obligations hereunder. Any references in this Agreement to Hutchison and the performance of Services by Hutchison (including but not limited to the general obligations set forth in ARTICLE 3 , standards of care relating to performance set forth in ARTICLE 7 , and limitations on Liability and indemnification set forth in ARTICLE 12 ) will include Subcontractors so engaged by Hutchison and performance of Services by such Subcontractors on behalf of Hutchison, respectively.
ARTICLE 10.
CONFIDENTIALITY
10.1. CONFIDENTIALITY. Each Party (the Receiving Party) agrees to keep in strict confidence all Confidential Information that the other Party (the Disclosing Party) provides, communicates or otherwise makes available to the Receiving Party and to protect the Confidential Information with the same degree of care normally used to protect its own Confidential Information of a similar nature. The Receiving Party will not disclose or allow disclosure of any Confidential Information to any Third Party and will not use any Confidential Information in any manner, except, in each case, for the purposes of implementing and enforcing this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement or any Ancillary Agreement, without the prior written consent of the Disclosing Party.
10.2. EXCEPTIONS. The restrictions and obligations set forth in Sections 10.1 , 10.5 and 10.6 will not apply to any Confidential Information:
(a) which is or becomes generally available to the public through no fault on the part of the Receiving Party;
(b) which is lawfully in the possession of the Receiving Party (other than pursuant to the terms of this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement, any Ancillary Agreement or any other related agreement), without restriction as to its disclosure, prior to the disclosure of such information by or on behalf of the Disclosing Party or the Company, as reasonably evidenced by appropriate documentation;
(c) which lawfully becomes available to the Receiving Party from a source other than the Disclosing Party and the Company without any duty as to confidentiality or non-use;
(d) which is independently developed or otherwise created by the Receiving Party (other than pursuant to the terms of this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement, any Ancillary Agreement or any other related agreement) without the use of any Confidential Information of the Disclosing Party, as reasonably evidenced by appropriate documentation; or
(e) which is required to be disclosed or provided to any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) (i) pursuant to any Applicable Laws, judgment, decree or order; (ii) as necessary to make regulatory filings and communications related to the Hutchison Compounds or any Products; or (iii) for the purpose of asserting or defending against any claims relating to Intellectual Property Rights, including, in particular, any action taken to protect and enforce Intellectual Property Rights; provided, however, that (x) any such information disclosed pursuant to this Section 10.2(e) will be disclosed only to the extent required by Applicable Laws, judgment, decree or order; (y) except with respect to
required disclosure to tax authorities, the Party seeking to disclose or provide such information will give the other Parties prompt written notice of such requirement and fully cooperate with the other Parties so that the other Parties and/or the Company (as the case may be) may obtain reasonable assurances that confidential treatment will be accorded to such information; and (z) without limiting the generality of the foregoing, the Parties will use commercially reasonable efforts to ensure that, subject to Applicable Laws, the list of the Products is redacted from any copy of this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement and any Ancillary Agreement required to be filed with any government or regulatory body.
10.3. ACCURACY OF CONFIDENTIAL INFORMATION. Each Party hereby acknowledges that the Confidential Information of the other Party may still be under development, or may be incomplete, and that such information may relate to products that are under development or are planned for development. Except as specifically provided in Section 7.2 and Section 7.3 , neither Party makes any representations regarding the accuracy of its Confidential Information.
10.4. REMEDIES FOR BREACH OF CONFIDENTIALITY OBLIGATIONS. The Parties acknowledge that it will be impossible to measure the damages that would be suffered by the other Party if a Party fails to comply with this ARTICLE 10 and that in the event of any such failure, there may not be adequate remedy under Applicable Laws. Each Party will, therefore, be entitled in addition to any other rights and remedies to obtain specific performance by the other Party of the obligations under this ARTICLE 10 and to obtain immediate injunctive relief without having to post a bond. Neither Party will urge, as a defense to any proceeding for such specific performance or injunctive relief by the other Party for breach of this ARTICLE 10 , that the other Party has an adequate remedy under Applicable Laws.
10.5. MEASURES TO KEEP CONFIDENTIALITY. Each Party agrees that, prior to giving access to any Confidential Information to any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, advisors, consultants and agents, it will require each such Person to agree to be bound by all obligations of confidentiality and non-use under this ARTICLE 10 , and will take all reasonable steps and measures to ensure that each such Person will enter into a confidentiality undertaking to comply with and perform such obligations, in each case to the same extent as if they were direct parties to this Agreement.
10.6. SURVIVAL OF OBLIGATIONS. The obligations undertaken by the Parties under this ARTICLE 10 will survive the termination of this Agreement for any reason and will remain in effect and be binding on the Parties for a period of ten (10) years after the termination of this Agreement; provided that to the extent any Confidential Information constitutes a trade secret, as defined in the U.S. Uniform Trade Secrets Act or any Applicable Laws, then the Receiving Party will keep such trade secret confidential until such time as the
Confidential Information no longer qualifies as a trade secret under Applicable Laws.
ARTICLE 11.
INTELLECTUAL PROPERTY RIGHTS
11.1. EXISTING OWNERSHIP RIGHTS UNAFFECTED. As between the Parties, each Party will own and retain all right, title and interest in its Background IP.
11.2. NO OTHER LICENSE. Except as expressly set out in this ARTICLE 11 , neither Party will gain, by virtue of this Agreement, any rights of ownership or use of copyrights, patents, trade secrets, trademarks or any other Intellectual Property Rights owned by the other Party.
11.3. OWNERSHIP OF PRODUCTS. Except as otherwise set forth in this Agreement, the Company will own all right, title and interest in and to: (a) any and all inventions, developments or discoveries made by Hutchison or its Affiliates and/or its respective employees, agents or independent contractors in connection with their activities under this Agreement; (b) any and all Patent Rights claiming any invention, development or discovery described in clause (a) of this Section 11.3 ; and (c) any and all Know-How embodied by or in any invention, development or discovery described in clause (a) of this Section 11.3 . Hutchison will take any action reasonably required to vest in the Company title to all such inventions, developments, discoveries and Patent Rights ( Development IP ). For clarity, the Parties agree that the Company will own all right, title and interest in any Development IP in all fields and indications and not just the Field. For the avoidance of doubt, any inventions, developments or discoveries and any related patent rights or know-how of a general nature which are made in connection with the Services, but which are not specific to a Hutchison Compound or Product ( Party IP ) will be owned by Hutchison. Hutchison hereby grants and will cause its Affiliates to grant to the Company and its Affiliates a fully-paid up, perpetual, non-exclusive license with the right to sublicense, to use, develop, have developed, manufacture, have manufactured, commercialize and have commercialized any Party IP so far as it is relevant to the Hutchison Compounds or a Product.
11.4. PATENTS; FURTHER ASSISTANCE. The Company may, at its sole discretion, file one or more applications for patents in relation to any Development IP. Hutchison will promptly execute and deliver (and cause any of its employees, agents or independent contractors to execute and deliver) any assignments, descriptions of other instruments as may be necessary or proper in the reasonable opinion of the Company to vest in the Company title to the Development IP and to enable the Company to obtain and maintain the entire right and title to the Development IP throughout the world. Hutchison will also render to the Company, at the Companys expense, such assistance as the Company may reasonably require in the preparation and prosecution of applications for patents in connection with its Development IP, and in any litigation in which the Company may be involved relating to its Development IP.
ARTICLE 12.
LIABILITY AND INDEMNIFICATION
12.1. LIABILITY FOR LOSS. Except (a) with respect to Liability arising from any willful misconduct or grossly negligent act of a Party or any of its Affiliates, (b) to the extent such Party may be required to indemnify any Hutchison Indemnified Party or Company Indemnified Party (as the case may be) from and against any Liability to one or more Third Parties under this ARTICLE 12 , and (c) to the extent such Liability arises from a breach of ARTICLE 10 , (x) in no event will either Party, any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, agents or representatives be liable under this Agreement for any special, indirect, incidental, consequential, punitive or exemplary damages, whether in contract, warranty, tort, negligence, strict liability or otherwise, including loss of profits or revenue suffered by either Party, any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, agents or representatives and (y) Hutchisons Liability for damages arising out of the Services provided hereunder will not exceed [**].
12.2. FORCE MAJEURE. Hutchison will be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by Force Majeure provided that Hutchison promptly provides notice of the prevention to the Company. Such excuse will be continued so long as the condition constituting Force Majeure continues and Hutchison takes commercially reasonable efforts to remove the condition.
12.3. COMPANY INDEMNIFICATIONS. The Company will indemnify, defend and hold harmless all Hutchison Indemnified Parties from and against all Liabilities resulting from or arising out of:
(a) any claims of any nature arising out of the development, manufacture, commercialization or use of any and all inventions, developments or discoveries made by Hutchison or its Affiliates employees, agents or independent contractors in connection with their activities under this Agreement, on behalf of, or under the authority of, the Company (other than by any Hutchison Indemnified Party), including but not limited to (i) government claims, (ii) product liability claims, and (iii) Intellectual Property claims, but excluding claims for which Hutchison is required to indemnify any of the Company Indemnified Parties pursuant to Section 12.4 below;
(b) any negligent or intentional act or omission of (i) the Company, (ii) any other Company Indemnified Party or (iii) any Third Party contractor engaged by the Company to perform activities under this Agreement for which the Company is responsible, in the course of or in connection with the performance of its obligations hereunder; or
(c) the breach by the Company of any of its representations, warranties or covenants, or any other provisions of this Agreement,
except, in each case, to the extent caused by the negligent or intentional acts or omissions of Hutchison, any other Hutchison Indemnified Party or any Subcontractor or any of its employees, officers, directors or agents or by the breach by Hutchison of any of its representations, warranties or covenants set forth in this Agreement. For the avoidance of doubt, the Company will in no event be liable to any Hutchison Indemnified Party for or in respect of any diminution in value of its equity or ownership interest in the Company that may result from, arise out of or be caused by any breach by the Company of its obligations to perform activities in compliance with Applicable Laws under Section 7.4 or as required by the other provisions of this Agreement.
12.4. HUTCHISON INDEMNIFICATIONS. Hutchison hereby agrees to indemnify, defend, and hold harmless any Company Indemnified Party from and against any and all Liabilities resulting from or arising out of:
(a) any negligent or intentional act or omission of (i) Hutchison, (ii) any other Hutchison Indemnified Party or (iii) any Subcontractor or any of its employees, officers, directors or agents in the course of or in connection with the performance of Services hereunder; or
(b) the breach by Hutchison of any of its representations, warranties, or covenants or any other provisions of this Agreement,
except, in each case, to the extent caused by the negligent or intentional acts or omissions of the Company, any other Company Indemnified Party or any Third Party contractor engaged by the Company to perform activities under this Agreement for which the Company is responsible or by the breach by the Company of any of its representations, warranties or covenants set forth in this Agreement.
12.5. INSURANCE. Hutchison will maintain insurance with respect to its activities hereunder. Such insurance will be in such amounts and subject to such deductibles as are customary based upon standards prevailing in the industry at the time.
ARTICLE 13.
MISCELLANEOUS
13.1. ENTIRE AGREEMENT. This Agreement, constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter hereof. 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 Appendices 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 Appendices and this Agreement, the terms of this Agreement will govern.
13.2. FURTHER ASSURANCE. Each Party will perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as the other Party may reasonably require to implement or give effect to this Agreement.
13.3. WAIVER AND NON-EXCLUSION OF REMEDIES. A Partys failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy will 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by Applicable Laws or otherwise available except as expressly set forth herein.
13.4. NOTICE REQUIREMENTS. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in this Section 13.4 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 Section 13.4 . Such Notice will be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second (2) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 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.
All correspondence to the Company will be addressed as follows:
Nutrition Science Partners Limited
22/F Hutchison House
10 Harcourt Road, Central, Hong Kong
Attn: The General Manager
Fax: +852 2128 1778
With a copy to:
The Finance Director
c/o Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: General Counsel
All correspondence to Hutchison will be addressed as follows:
Hutchison MediPharma Limited
Building 4, 720 Cailun Road
Zhangjiang High Tech Park
Shanghai, China 201203
Attn: Chief Executive Officer
Fax: +86 21 5079 3900
With a copy to:
Hutchison Whampoa Limited
22/F Hutchison House
10 Harcourt Road Central
Hong Kong
Attn: Head Group General Counsel & Company Secretary
Fax: +852 2128 1778
13.5. ASSIGNABILITY. This Agreement and each and every covenant, term and condition hereof will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Neither this Agreement nor any rights or obligations hereunder may be assigned, delegated or transferred, directly or indirectly, by a Party to any Third Party without the prior written consent of the other Party. The restrictions set out in this Section 13.5 will not apply to any assignment of this Agreement by Hutchison to an Affiliate. Any attempted assignment or delegation in violation of this Section will be void.
13.6. AMENDMENTS. Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of all Parties.
13.7. GOVERNING LAW. The interpretation and construction of this Agreement will be governed by the laws of England and Wales.
13.8. DISPUTE RESOLUTION. In the event of a dispute arising out of or relating to this Agreement, (including regarding its existence, termination or validity) (a Dispute) any Party will provide written notice of the Dispute to the other Parties, in which event the Dispute will be referred to the executive officers of the Shareholders designated below or their successors. The designated officers will use reasonable efforts to attempt resolution by good faith negotiations within [**] days after such notice is received. Said designated officers are initially as follows:
Hutchison: The Chief Executive Officer
Company: The General Manager and the Finance Director
In the event the designated executive officers do not resolve such Dispute within the allotted [**] days, any Party may, after the expiration of the [**] day period, seek to resolve the Dispute through reference to arbitration in accordance with Section 13.9 . Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations
hereunder, will not be deemed a Dispute which may be referred for resolution by the Parties under this Section 13.8 .
13.9. ARBITRATION. All Disputes which are unresolved pursuant to Section 13.8 and which a Party wishes to have resolved will be referred upon the application of any Party to, and finally settled by, arbitration in accordance with the ICC Arbitration Rules (the Rules) as in force at the date of this Agreement and as modified by this Section 13.9 , which Rules are deemed incorporated into this Section 13.9 . The number of arbitrators will be three (3), one of whom will be appointed by each Shareholder and the third of whom, who will act as chairman, will be nominated by the two party nominated arbitrators, provided that if the third arbitrator has not been nominated within twenty (20) Business Days of the nomination of the second party nominated arbitrator, such third arbitrator will be appointed by the ICC. The seat of arbitration will be London and the language of arbitration will be English.
The arbitrators will have the power to grant any legal or equitable remedy or relief available under law, including injunctive relief (whether interim and/or final) and specific performance, and any measures ordered by the arbitrators may be specifically enforced by any court of competent jurisdiction. Each Party retains the right to seek interim or provisional measures, including injunctive relief and including pre arbitral attachments or injunctions, from any court of competent jurisdiction and any such request will not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate. For the avoidance of doubt, this Section 13.9 is not intended to limit the powers of the court exercisable in support of arbitration proceedings pursuant to Section 44 of the Arbitration Act 1996 or any Applicable Law.
13.10. DISCREPANCY OF TERMS. Unless otherwise provided, all terms of this Agreement are subject to the terms of the Joint Venture Agreement, and in the event of any conflict or discrepancy between the terms of this Agreement and the terms of the Joint Venture Agreement, the latter will prevail unless otherwise specifically stated in this Agreement.
13.11. SEVERABILITY. To the fullest extent permitted by Applicable Laws, the Parties waive any provision of Applicable Laws that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and will not form part of this Agreement. To the fullest extent permitted by Applicable Laws and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement will remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Laws and achieves, as nearly as possible, the original intention of the Parties.
13.12. COUNTERPARTS. This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which taken together will be deemed to constitute one and the same instrument. An
executed signature page of this Agreement delivered by facsimile transmission will be as effective as an original executed signature page.
13.13. NO BENEFIT TO OTHERS. 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 in any other Persons except as otherwise expressly provided in this Agreement. A Person who is not a Party will have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the terms of this Agreement.
13.14. 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 in the event of any conflict in interpretation between the English version and such translation, the English version will prevail. English will be the official language of this Agreement and all communications between the Parties will be conducted in that language.
ARTICLE 14.
DEFINITIONS
The terms defined in this Article will have the meanings ascribed to them herein whenever they are used in the Agreement, unless otherwise clearly indicated by the context. Any capitalized terms used in this Agreement and not defined in this ARTICLE 14 will have the meaning ascribed to them in the Joint Venture Agreement and any reference to Party or Parties will in such defined terms will be interpreted as a reference to a Party or the Parties to this Agreement and any reference to this Agreement will be interpreted as a reference to this Agreement.
14.1. Background IP will mean any Intellectual Property Controlled by a Party prior to the Effective Date or, any Intellectual Property Controlled by a Party that is not Development IP, whether protectable or not in the US or abroad by Intellectual Property Rights.
14.2. Company Indemnified Party will mean the Company, each of its Affiliates and each of its, its Affiliates respective employees, officers, directors and agents.
14.3. Company Know-How means any Information that is necessary or useful for the manufacture, use or sale of the Hutchison Compound or a Product.
14.4. Company Patent Rights means any Patent Right that is necessary or useful for the manufacture, use or sale of the Hutchison Compound or a Product.
14.5. Company Technology means collectively, the Company Know-How and Company Patent Rights.
14.6. Development IP will have the meaning set forth in Section 11.3 .
14.7. Dispute will mean a dispute over an amount due on an invoice delivered pursuant to this Agreement.
14.8. Dispute Escalation Notice will mean written notice provided by a Party to the other Party referring a Dispute to the respective officers of the Parties for resolution, if resolution could not be made by the Parties themselves pursuant to Section 5.4(c) .
14.9. Effective Date will have the meaning set forth in the introduction to this Agreement.
14.10. Expiration Date will mean the date on which all Services under all Service Schedules have been completed to the satisfaction of the Company or are deemed to be Impracticable.
14.11. Field will mean the treatment, prevention or diagnosis of gastrointestinal diseases, disorders or conditions in humans or any other field as agreed between the Parties.
14.12. Force Majeure will mean an event that is beyond a non-performing Partys reasonable control, including an act of God, strike, lock-out or other industrial/labor dispute not involving the non-performing Partys own employees, war, riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster or compliance with any law or governmental order, rule, regulation or direction, whether or not it is later held to be invalid or inapplicable.
14.13. FTE means full-time equivalent, or the equivalent of a full-time employees work time.
14.14. Hutchison Compounds means HMPL-004 and any other compound included in the Hutchison Library as agreed between the Parties to this Agreement.
14.15. Hutchison Indemnified Party will mean Hutchison, each of its Affiliates, and each of its and its Affiliates respective employees, officers, directors and agents.
14.16. Impracticability will mean the inability of Hutchison to perform a Service because such performance is Impracticable.
14.17. Impracticable will mean circumstances in which Hutchison is unable to perform a Service as a result of a cause or causes beyond the reasonable control of Hutchison (including Force Majeure or scientific impossibility) or because the performance of such Service would require Hutchison to violate any Applicable Laws or would result in the breach of any software license or other applicable contract by Hutchison, provided that such inability of Hutchison was not the result of the fault or negligence of Hutchison and/or any of its Affiliates and Hutchison and its Affiliates have been unable to overcome such inability with the exercise of due diligence (including the expenditure of reasonable sums). For the purposes of clarity, where
Hutchison is unable to perform a Service as a result of any non-performance by the Company of its obligations hereunder, such Service will also be deemed Impracticable for so long as the Company fails to cure such non-performance.
14.18. Information means any data, results, technology or information of any type whatsoever, in any tangible or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, inventions, developments, specifications, formulations, formulae, materials or compositions of matter of any type or kind (patentable or otherwise), software, algorithms, marketing reports, expertise, technology, test data (including pharmacological, biological, chemical, biochemical and clinical test data and data resulting from non-clinical studies), chemistry, manufacturing and controls (CMC) information, stability data and other study data and procedures.
14.19. Invoice Dispute will mean a dispute over an amount due on an invoice delivered pursuant to this Agreement.
14.20. Invoice Dispute Escalation Notice will mean written notice provided by a Party to the other Party referring a Dispute to the respective officers of the Parties for resolution, if resolution could not be made by the Parties themselves pursuant to Section 5.4(c) .
14.21. Joint Venture Agreement will have the meaning set forth in the recitals.
14.22. Know-How will mean any invention, discovery, trade secret, data, information, process, method, technique, material (including any chemical or biological material), technology, result, cell line, compounds, probe, sequence or other know-how, whether or not patentable.
14.23. Liability will mean any and all Third Party claims, suits, losses, liabilities, damages, costs, fees and expenses, including reasonable attorneys fees and expenses of litigation incurred by any Hutchison Indemnified Party or any Company Indemnified Party (as applicable) in connection therewith.
14.24. Materials and Third Party Costs will have the meaning set forth in Section 5.1 .
14.25. Notice of Invoice Dispute will mean written notice of a Dispute not resolved in the normal course of business, given by a Party to the other pursuant to Section 5.4(c) .
14.26. Party or Parties will mean either or both of Hutchison and the Company.
14.27. Party IP will have the meaning set forth in Section 11.3 .
14.28. Service(s) will mean the activities to be conducted by Hutchison pursuant to the Service Schedules.
14.29. Services Budget will mean the annual budget for the provision of Services under this Agreement approved by the Board of the Company, as updated and amended from time to time.
14.30. Service Schedule will mean a schedule describing the Services to be performed hereunder as approved by the Board of the Company on an annual basis alongside the Services Budget, including the anticipated timeline for the conduct of such Services and the FTEs to be employed in performing such Services, the initial agreed upon version of which is attached hereto as Appendix 1 , as such schedule may be amended from time to time in accordance with the terms hereof.
14.31. Subcontractor will mean any Person engaged by Hutchison pursuant to Section 9.2 to perform Services hereunder on behalf of Hutchison.
14.32. Term will mean the term commencing on the Effective Date and ending on the Expiration Date, as such period may be extended in accordance with the terms hereof, or an earlier date on which this Agreement is terminated by a Party in accordance with ARTICLE 8 .
14.33. VAT means value added tax.
[Remainder of this page intentionally left blank]
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed in duplicate originals by its duly authorized representative.
和记黄埔医药 ( 上海 ) 有限公司 Hutchison MediPharma Limited
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By: Christian Hogg |
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Title: Director |
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Date: |
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Nutrition Science Partners Limited |
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By: Christian Hogg |
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Title: Director |
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Date: |
[Signature Page to the Hutchison Services Agreement]
Appendix 1
Service Schedules
2013 Service Schedule
Scope |
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Timing |
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Description (including third party
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Number &
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Services
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HMPL-004 Clinical & Regulatory Services |
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Q2 2013 onwards |
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[**] |
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US$[**] per year
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HMPL-004 Chemistry, Manufacturing & Control (CMC) |
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Q1 2013 onwards |
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[**] |
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[**] per year |
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HMPL-004 Discovery Research |
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Q1 2013 onwards |
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[**] |
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[**] |
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[**] per year |
EXHIBIT E
RESEARCH AND DEVELOPMENT COLLABORATION AGREEMENT
BY AND AMONG
和 记黄埔医药 ( 上海 ) 有限公司 HUTCHISON MEDIPHARMA LIMITED
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NESTLÉ HEALTH SCIENCE S.A.
AND
NUTRITION SCIENCE PARTNERS LIMITED
[DATE]
TABLE OF CONTENTS
ARTICLE 1 INTERPRETATION |
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ARTICLE 2 CONDUCT OF THE RESEARCH |
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ARTICLE 3 RESEARCH; EXCLUSIVITY; EXTENDED COLLABORATION |
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ARTICLE 4 GOVERNANCE |
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ARTICLE 5 EVALUATION |
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ARTICLE 6 COMPENSATION |
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ARTICLE 7 TAXES AND WITHHOLDING |
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ARTICLE 8 WARRANTIES AND PERFORMANCE |
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ARTICLE 9 TERMINATION |
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ARTICLE 10 |
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ARTICLE 11 RELATIONSHIP BETWEEN THE PARTIES |
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ARTICLE 12 CONFIDENTIALITY |
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ARTICLE 13 INTELLECTUAL PROPERTY RIGHTS |
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ARTICLE 14 LIABILITY AND INDEMNIFICATION |
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ARTICLE 15 MISCELLANEOUS |
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ARTICLE 16 DEFINITIONS |
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Appendix
Appendix 1 Research Plan
RESEARCH AND DEVELOPMENT COLLABORATION AGREEMENT
This Research and Development Collaboration Agreement (the Agreement ) is made and entered into as of [] (the Effective Date ), by and among 和 记 黄埔医 药 ( 上海 ) 有限公司 Hutchison MediPharma Limited, a limited company incorporated under the laws of the Peoples Republic of China ( Hutchison ), Nestlé Health Science S.A. a company incorporated under the laws of Switzerland ( Nestlé ) and Nutrition Science Partners Limited, a limited company incorporated under the laws of Hong Kong (the Company ).
RECITALS
WHEREAS, Hutchison MediPharma (Hong Kong) Limited, a company organized and existing under the laws of Hong Kong, the Company, Hutchison China MediTech Limited and Nestlé have entered into a Joint Venture Agreement on [ · ] November 2012 (the Joint Venture Agreement ) memorializing their mutual agreements and understandings on the establishment, financing, operation and management of the Company and their respective rights and obligations relative thereto.
WHEREAS, the Company is responsible for research and development activities to identify and develop novel naturally-derived medical foods, food supplements or drug products derived from compounds from the Hutchison Library utilizing the Hutchison Botanical R&D Platform in the Research Field, Hutchison and Nestlé will perform certain research activities on behalf of the Company as described in this Agreement.
WHEREAS, the research collaboration outlined in this Agreement aims to achieve [**].
WHEREAS the research collaboration outlined in this Agreement is intended to govern [**]. The further clinical development of such Products or Hutchison Compounds will be part of a separate clinical development plan as established by and paid for by the Company pursuant to the Joint Venture Agreement.
NOW, THEREFORE, in consideration of the foregoing and the mutual promises herein made, and other valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
ARTICLE 1
INTERPRETATION
Unless otherwise required by the context or unless otherwise specified herein, (a) the use of any gender herein will be deemed to encompass references to either or both genders, and the use of the singular will be deemed to include the plural (and vice versa), (b) the words include, includes and including will be deemed to be followed by the phrase without limitation, (c) any definition of or reference to any agreement, instrument or other document herein will be construed as referring to such agreement, instrument or other document as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments,
supplements or modifications set forth herein), (d) any reference herein to any Person will be construed to include the Persons successors and assigns, (e) the words herein, hereof and hereunder, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (f) all references herein to Articles, Sections or Appendices will be construed to refer to Articles, Sections or Appendices of this Agreement, and references to this Agreement include all Appendices hereto, (g) the word notice will mean notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, (h) provisions that require that a Party, the Parties or any committee hereunder agree, consent or approve or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes or otherwise (but excluding e-mail and instant messaging) and (i) references to any specific law, rule or regulation, or article, section or other division thereof, will be deemed to include the then-current amendments thereto or any replacement or successor law, rule or regulation thereof.
ARTICLE 2
CONDUCT OF THE RESEARCH
2.1. CONDUCT OF THE RESEARCH GENERALLY. This Agreement will govern the conduct of the Research by Hutchison and Nestlé. Each of Hutchison and Nestlé will use commercially reasonable efforts to conduct the activities designated for such Party under the Research Plan, with the initial agreed upon Research Plan attached to and made part of this Agreement as Appendix 1 . Nestlé may conduct the Research under this Agreement either directly or through any of its Affiliates.
2.2. INCONSISTENCIES. If there is any inconsistency between the terms of the Research Plan and the terms of this Agreement, the terms of this Agreement will prevail.
2.3. SCOPE OF RESEARCH. The Research Plan (as such may be amended pursuant to ARTICLE 4 ) outlines the activities to be conducted by Hutchison and Nestlé pursuant to this Agreement. The Research Plan and each amendment thereto, will include a detailed list of the research activities to be performed by Hutchison and Nestlé, a timeline for the performance of such activities and FTE resource allocation.
2.4. DOCUMENT RETENTION. Each of Hutchison and Nestlé will maintain, in accordance with its standard document retention procedures, documentation supporting the FTEs activities conducted under the Research Plan, and will cooperate with the Company in making such documentation and information available as needed.
ARTICLE 3
RESEARCH; EXCLUSIVITY; EXTENDED COLLABORATION
3.1. RESEARCH GENERALLY.
(a) Access to Hutchison Library and Hutchison Botanical R&D Platform . Hutchison will provide the Company and any agent of the Company that is subject to confidentiality obligations no less restrictive than those set forth herein with full access to the Hutchison Library and Hutchison Botanical R&D Platform during the Exclusivity Period to perform the Research in accordance with the Research Plan.
(b) No Guarantee . The Company acknowledges that due to the nature of the Research to be performed hereunder and the timelines set forth in the Research Plan, neither Hutchison nor Nestlé is able to guarantee that any particular results will be achieved in respect of any Research, despite performance by Hutchison and Nestlé in accordance with this Agreement.
3.2. IMPRACTICABILITY.
(a) Impracticability . Subject to Section 3.2(b) below, neither Hutchison nor Nestlé will be required to perform any Research to the extent the performance of such Research becomes Impracticable.
(b) Notice of Impracticability . Should either Hutchison or Nestlé determine that the performance of any portion of the Research has become Impracticable it will immediately notify the other Parties in writing, specifying in reasonable detail (i) the event or circumstance that has rendered the conduct of such Research Impracticable, (ii) the scope and extent of the Research affected thereby, (iii) the expected duration of such event or circumstance and (iv) the measures that Hutchison or Nestlé (as the case may be) proposes to undertake to avoid or minimize the effect of such event or circumstance on its ability to perform such Research hereunder. Hutchison and/or Nestlé (as the case may be) will, as promptly as reasonably practicable, resume performing such Research once the performance of the relevant portion of Research is no longer Impracticable. The Parties will negotiate in good faith any reduction that any Party reasonably believes should be made to the compensation under ARTICLE 6 as a result of such Impracticability.
3.3. ADDITIONAL RESOURCES. Hutchison and Nestlé will obtain the resources necessary to perform the Research as provided in the Research Plan. For clarity, unless the Parties otherwise agree in writing, neither Hutchison nor Nestlé will be obligated to obtain additional resources not contemplated by the Research Plan, including (i) hiring, leasing or contracting for any additional employees, (ii) maintaining the employment of any specific employee, or (iii) purchasing, leasing or licensing any additional equipment or software.
3.4. EXCLUSIVITY.
(a) Grant of Exclusivity . Subject to the terms and conditions of this Agreement, Hutchison hereby grants to the Company, and the Company hereby accepts, a first and exclusive right, during the Exclusivity Period, to conduct Research (or have conducted Research by Nestlé and Hutchison in accordance with this Agreement) to evaluate and develop Products and Hutchison Compounds from the Hutchison Library and the use of Hutchison Botanical R&D Platform in the Research Field (the Exclusivity Grant ).
(b) Exclusivity . During the Exclusivity Period, Hutchison hereby covenants and agrees that it will not (i) conduct Research or development activities for itself or on behalf of any Third Party to identify and develop Products and Hutchison Compounds from the Hutchison Library and Hutchison Botanical R&D Platform in the Research Field (other than pursuant to this Agreement), (ii) grant to a Third Party any right to evaluate, develop or negotiate with Hutchison for any agreement providing rights with respect to the Hutchison Library and the use of the Hutchison Botanical R&D Platform for development or potential commercialization worldwide in the Research Field, or (iii) assign, license or otherwise transfer to or for the benefit of a Third Party any right in or to, or otherwise take any action to encumber, in whole or in part, the Hutchison Library and the use of the Hutchison Botanical R&D Platform in the Research Field, or any Intellectual Property Rights related thereto, to any extent or in any manner that is inconsistent with, or in violation of, the Companys exclusive rights granted under the Exclusivity Grant.
3.5. Exclusivity Period . The initial exclusivity period will start on the date of this Agreement and will end on [**] (the Initial Exclusivity Period ); provided that, during the Exclusivity Period, the Company will budget a minimum research budget (as set out in the Research Annual Budget from time to time) of, and spend a minimum amount of, at least [**] per calendar year on the conduct of Research to evaluate and develop Products and Hutchison Compounds from the Hutchison Library and with the use of Hutchison Botanical R&D Platform. The Exclusivity Period will be [**] provided that the Company budgets a minimum research budget in the then applicable Research Annual Budget of, and spends an amount of, at least [**] in such calendar year on such Research.
3.6. Extension of Research Field Definition . Any amendment of the Research Field definition will require unanimous approval of the Parties. The Parties will discuss in good faith to extend the definition of Research Field under this Agreement to include metabolic health and brain health after the second anniversary of this Agreement.
ARTICLE 4
GOVERNANCE
4.1. RESEARCH COLLABORATION SUBCOMMITTEE. The Parties agree to form and maintain a research collaboration subcommittee ( Research Collaboration Subcommittee ). This subcommittee will consist of six (6) members, with an equal number of representatives from the Company (to be designated by Nestlé) and from Hutchison, and as far as practicable, such representatives being part of the research and development or commercial teams of each Party. All decisions by the Research Collaboration Subcommittee will be made by unanimous agreement of the members on the Research Collaboration Subcommittee and any decisions on which the Research Collaboration Subcommittee cannot agree will be referred to an executive officer of each Party for attempted resolution by good faith negotiations between such officers.
4.2. FREQUENCY OF GOVERNANCE MEETINGS. The Research Collaboration Subcommittee will meet quarterly, or more often as mutually agreed upon by the Parties. Reasonably in advance of each meeting of the Research Collaboration Subcommittee, (a) Hutchison will provide a summary of the Research conducted by Hutchison since the prior meeting of the Research Collaboration Subcommittee and the results obtained from such Research and (b) Nestlé will provide a summary of the Research conducted by Nestlé since the prior meeting of the Research Collaboration Subcommittee and the results obtained from such Research.
4.3. RESPONSIBILITIES OF THE RESEARCH COLLABORATION SUBCOMMITTEE. The Research Collaboration Subcommittee will have responsibility for (a) preparing and submitting, no later than sixty (60) days before the end of each calendar year, to the Parties, a revised Research Plan (including a Research Annual Budget for the next calendar year); (b) overseeing the Research conducted under this Agreement to ensure that the Research proceeds according to the Research Plan; (c) assessing the results obtained from the Research; and (d) recommending and advising whether a new IND may be developed in any additional fields than the Research Field.
4.4. RESEARCH PLAN.
(a) Approval of Research Plan . The Parties will within thirty (30) days from the date the Research Plan has been received from the Research Collaboration Subcommittee, convene a meeting (whether telephonically or in person) to approve the Research Plan (including the Research Annual Budget). The Parties acknowledge that the Board will have to review and approve the proposed Research Plan prior to such meeting.
(b) Non-Material Revisions to Research Plan . The Research Collaboration Subcommittee will be able to make non-material revisions to the Research Plan for operational reasons provided always that such non-material revisions are notified to the Parties in writing.
4.5. PROJECT MANAGER. In addition to the Research Collaboration Subcommittee, the Company will, as soon as reasonably practicable after the Effective Date, appoint a project manager, who will be responsible for overseeing the day-to-day conduct of the Research hereunder to ensure that Research is conducted according to the Research Plan.
4.6. FTE. Hutchison and Nestlé will ensure that all employees of such Party performing Research activities hereunder are subject to appropriate obligations (in their employment agreements or otherwise), subject to the terms of this Agreement, to assign all Intellectual Property Rights developed pursuant to this Agreement to the Company.
ARTICLE 5
EVALUATION
5.1. NOTICE OF NEW PRODUCT, HUTCHISON COMPOUND, IND. During the Exclusivity Period, the Research Collaboration Subcommittee will give to the Company written notice of any new Hutchison Compound invented, developed or discovered
and/or IND filed as soon as practicable upon the occurrence of such invention, development, discovery or filing, such notice is to include details of such Product, Hutchison Compound and/or IND including the relevant fields of development of such Product, Hutchison Compound and/or IND.
5.2. COOPERATION. As may be reasonably requested by the Company, Hutchison or Nestlé, as the case may be, will provide the Company with reasonable assistance and cooperation to facilitate the Companys efforts in carrying out any evaluation of such new Hutchison Compound, or any Product incorporating such Hutchison Compound and/or IND. Following such evaluation, Hutchison or Nestlé, as the case may be, will conduct such additional development activities as requested by the Company at the Companys expense.
ARTICLE 6
COMPENSATION
6.1. COMPENSATION FOR MATERIALS AND THIRD PARTY COSTS. The Company will reimburse Hutchison or Nestlé for all reasonable out-of-pocket costs incurred by Hutchison or Nestlé for supplies and materials, as well as for all costs reasonably incurred by Hutchison or Nestlé to any Third Party, used in connection with performing the Research (the Materials and Third Party Costs ) provided such Materials and Third Party Costs are within the then applicable Research Annual Budget. Such costs will include all property taxes, value added taxes, customs and duties (except to the extent such taxes, customs or duties are recoverable by or refundable to Hutchison or Nestlé) levied on, as well as all other actual out-of-pocket expenses associated with the purchase, use, transportation and insurance of, such supplies and materials.
6.2. COMPENSATION FOR RESEARCH.
(a) Reimbursement for Research . In consideration of the performance of the Research by Hutchison or Nestlé, the Company will reimburse Hutchison and Nestlé for actual time spent by Hutchison and Nestlé personnel performing the Research under the Research Plan on the basis of the number of FTEs performing activities under the Research Plan multiplied by the FTE Rate and all reasonable out-of-pocket costs incurred by Hutchison and Nestlé in performing such Research..
(b) Limitations on Reimbursement and Compensation . Notwithstanding anything herein to the contrary, the Company will not be obligated to reimburse Hutchison or Nestlé for costs of Research (including reimbursement of Materials and Third Party Costs pursuant to Section 6.1 ) to the extent that such reimbursement exceeds such costs as set forth in the Research Annual Budget by more than [**] of the originally budgeted amount, unless such excess is approved by the Board.
6.3. PAYMENT TERMS.
(a) Invoices . Within [**] days after the end of each calendar quarter, each of Hutchison and Nestlé will provide a quarterly invoice to the Company detailing all charges for supplies, materials, and the number of FTEs performing Research during the most recently concluded calendar quarter pursuant to this Agreement. With each such invoice, each of Hutchison and Nestlé will inform the Company in reasonable detail of the Research performed during the period covered by such
invoice and the costs, fees and charges to be included in such invoice. Each of Hutchison and Nestlé will also provide the Company with such supporting records and other materials as may be reasonably requested by the Company to review and verify the Research performed during such invoice period and the accuracy of the calculation of such costs, fees and charges. Payment will be remitted within [**] days from the date such invoice is received by the Company.
(b) Payment . Any payment under this ARTICLE 6 that is more than [**] days past due will be subject to interest at an annual percentage rate of [**] month London Interbank Offered Rate plus [**] basis points.
6.4. CORRECTION; TRUE-UPS; ACCOUNTING.
(a) Accounting Record Retention . Hutchison and Nestlé will, and will cause each of their respective Affiliates and Subcontractors to, keep and maintain complete and accurate books and records of the Research performed hereunder and the FTEs performing such Research for three (3) years after the close of the calendar quarter in which the relevant costs, fees and/or charges are incurred or assessed. These books and records will be kept in detail sufficient to allow for all costs, fees, and charges incurred or assessed for all Research to be properly verified and calculated.
(b) Audit . Upon thirty (30) days prior written notice from the Company, but not more than once annually, each of Hutchison and Nestlé will permit an independent certified public accounting firm of internationally recognized standing selected by the Company and approved by Hutchison or Nestlé (as the case may be), such approval not to be unreasonably withheld, delayed or conditioned, to examine, audit and copy, at the Companys sole expense, the relevant books and records of Hutchison, Nestlé and each of its Affiliates and Subcontractors reasonably related to the conduct of any Research under this Agreement for the sole purpose of verifying the amounts invoiced by Hutchison or Nestlé hereunder. The accounting firm will be provided reasonable access to such books and records at the facility(ies) of Hutchison, Nestlé and/or each of its Affiliates and Subcontractors where such books and records are normally kept and such examination will be conducted during the normal business hours of Hutchison, Nestlé and/or each of its Affiliates and Subcontractors. Each of Hutchison and Nestlé may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to such facilities or books and records. Upon completion of the audit, the accounting firm will provide both Hutchison or Nestlé (as the case may be) and the Company a written report disclosing any discrepancies in the quarterly invoices submitted or the reimbursements paid by the Company, and, in each case, the specific details concerning any discrepancies.
(c) Dispute . Any good faith Invoice Dispute will be immediately subject to the provisions of this Section 6.4(c) . The Parties agree that disputes related to any other agreement will not serve as grounds to delay any conduct of Research or payment obligations under this Agreement.
(i) The Parties will negotiate in good faith to resolve, pursuant to the procedures described in Section 6.4(c)(ii) , any Invoice Dispute. Notwithstanding the foregoing, any Party may seek preliminary or emergency injunctive relief in relation to an Invoice Dispute so as to maintain the status quo (including, but not limited to, maintaining the confidentiality of any non-public information) without or prior to initiating negotiations with the other Parties until the Invoice Dispute is otherwise resolved.
(ii) Any Party may give the other Parties a Notice of Invoice Dispute. Within [**] Business Days after delivery of such Notice of Invoice Dispute, executives of each Party who have authority to settle the Invoice Dispute will participate in conference or video calls or agree to meet at a mutually acceptable time and place, and thereafter as often as they reasonably deem necessary, consult and negotiate with each other in good faith and, recognizing their mutual interests, attempt to reach a just and equitable solution satisfactory to the Parties. If the Invoice Dispute has not been resolved within [**] days of the first discussion between such executives (or, if the Parties are unable to mutually agree upon an acceptable time and place to discuss, within [**] days of the disputing Partys Notice of Invoice Dispute), any Party may issue an Invoice Dispute Escalation Notice and refer the Invoice Dispute to the respective officers of the Parties designated below.
For Hutchison: The Chief Executive Officer
For Nestlé: President and Chief Executive Officer
For the Company: The General Manager and the Finance Director
Such officers will negotiate in good faith to resolve the Invoice Dispute in a manner satisfactory to the Parties within [**] days of the Invoice Dispute Escalation Notice. In the event the Invoice Dispute is not resolved within such [**] day period, any Party may proceed in accordance with Section 15.9 .
ARTICLE 7
TAXES AND WITHHOLDING
7.1. TAXES AND WITHHOLDING. [**].
ARTICLE 8
WARRANTIES AND PERFORMANCE
8.1. PERFORMANCE. Subject to Section 3.2 and Section 3.3 , and the other terms and conditions of this Agreement, Hutchison and Nestlé will commit personnel to the timely performance of Research under the Research Plan, in compliance with Applicable Laws.
8.2. WARRANTIES.
8.2.1 Each Party warrants and covenants to the other that (a) it has the full power and authority to enter into and fully perform this Agreement, (b) it has sufficient right and authority to grant all licenses and rights granted or agreed to be granted by it hereunder to the other Parties, and (c) at all times, it will comply with all Applicable Laws.
8.2.2 Hutchison warrants to Nestlé and the Company as of the Effective Date that:
(a) Hutchison has the right to grant to Nestlé and the Company the rights that it purports to grant Nestlé and the Company hereunder, including the right to grant exclusivity to the Hutchison Library and Hutchison Botanical R&D Platform as set forth in the Exclusivity Grant;
(b) Hutchison has not granted to any Third Party, including any academic organization or agency, any rights to the Hutchison Library and Hutchison Botanical R&D Platform for Research in the Research Field which are still in effect as of the Effective Date;
(c) Hutchison has not granted any Third Party rights that would otherwise interfere or be inconsistent with Nestlé and the Companys rights hereunder, and there are no license or option agreements or other arrangements to which Hutchison or any of its Affiliates is a party relating to the Hutchison Library or otherwise that would limit the rights granted to Nestlé or the Company under this Agreement;
(d) To the knowledge of Hutchison, its Affiliates and the key employees and consultants involved in the development, creation and operation of the Hutchison Library and/or the Hutchison Botanical R&D Platform, each of the Hutchison Library and the Hutchison Botanical R&D Platform does not infringe or misappropriate, or have not infringed or misappropriated the Intellectual Property Rights of any Third Party; and
(e) (A) Neither Hutchison nor any employee, agent or subcontractor of Hutchison involved or to be involved in the development of the Hutchison Compounds or Products has been debarred under Subsection (a) or (b) of Section 306 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 335a); (B) no Person who is known by Hutchison to have been debarred under Subsection (a) or (b) of Section 306 of said Act will be employed by Hutchison in the performance of any activities hereunder; and (C) to the knowledge of Hutchison, no Person on any of the FDA Clinical Investigator Enforcement Lists (including, but not limited to, the (1) Disqualified/Totally Restricted List, (2) Restricted List and (3) Adequate Assurances List) will participate in the performance of any activities hereunder.
8.3. WARRANTIES AND DISCLAIMER. Hutchison and Nestlé severally warrants to the Company that all Research conducted hereunder will be in accordance with the terms of
this Agreement. Neither Hutchison nor Nestlé makes any other warranties with respect to the Research conducted by it hereunder.
8.4. PERFORMANCE BY THE COMPANY. Subject to the other terms and conditions of this Agreement, the Company will use its commercially reasonable efforts to coordinate with Hutchison and Nestlé for the timely performance of the Research by Hutchison and/or Nestlé under the Research Plan, in compliance with Applicable Laws. Hutchison and/or Nestlé may change its policies, procedures and practices at any time upon reasonable prior notice to the Company; provided, however, that such changes, if not required by Applicable Laws, do not affect the conduct of the Research hereunder; and provided, further, that the compensation due by the Company to Hutchison or Nestlé as a result of such changes will not be increased.
8.5. MUTUAL RESPONSIBILITIES. In addition to the terms provided in Sections 8.1 and 8.4 , the Parties will use good faith efforts to cooperate with each other in all matters relating to the provision and conduct of the Research. Such cooperation will include:
(a) providing and exchanging information and documentation reasonably necessary for Hutchison and Nestlé to conduct the Research it is obligated to provide hereunder;
(b) making available, as reasonably requested by any Party, reasonable access to resources and providing timely decisions in order that each Party may perform its obligations hereunder;
(c) requiring each Partys personnel to obey any and all security regulations and other published policies of the other Parties while on the other Parties premises; and
(d) using commercially reasonable efforts to obtain all Third Party consents, licenses, sublicenses or approvals necessary to permit Hutchison and Nestlé to perform its obligations hereunder.
ARTICLE 9
TERMINATION
9.1. TERM . This Agreement will continue until the expiration of the Exclusivity Period unless earlier terminated in accordance with this ARTICLE 9 and ARTICLE 10.
9.2. TERMINATION.
(a) Company Termination .
(i) Termination of Research . The Company may terminate this Agreement, for any reason or for no reason, at any time upon giving written notice to Hutchison and Nestlé at least ninety (90) days prior to the Effective Date of such termination.
(ii) Payment of Costs Associated with Company Termination . If the Company terminates this Agreement under this Section 9.2(a) (where the Company does not have the right to
terminate this Agreement pursuant to Section 9.2(b) or 10.1 below), the Company will pay to Hutchison and Nestlé all non-cancellable costs incurred pursuant to the Research Plan imposed by Third Parties as a result of such termination. Each of Hutchison and Nestlé will inform the Company of such costs upon receipt of the termination notice and will undertake commercially reasonable efforts to mitigate such Third Party costs to the extent possible.
(b) Termination upon Material Breach . Notwithstanding the foregoing, a Party may terminate this Agreement if any other Party materially breaches a material provision of this Agreement and such material breach is not cured (i) within thirty (30) days after being given notice of the breach in the case of a material breach of an obligation to make payment hereunder or (ii) within sixty (60) days after being given notice of the breach in the case of any other material breach.
ARTICLE 10
10.1. Immediate Right to Terminate . A Party may immediately terminate this Agreement upon written notice to the other Parties if, at any time, (i) any other Party files for or is subject to the institution of bankruptcy, reorganization, liquidation or receivership proceedings, (ii) any other Party assigns all or a substantial portion of its assets for the benefit of creditors, (iii) a receiver or custodian is appointed for any other Partys business, (iv) a substantial portion of any other Partys business is subject to attachment or execution process based on a final, non-appealable court judgment or order or arbitral award, or (v) the Joint Venture Agreement has terminated; provided, however, that in the case of any involuntary bankruptcy, reorganization, liquidation or receivership proceeding under clause (i) above, no right of termination will arise unless and until such proceeding remains undismissed for at least ninety (90) days after the commencement thereof.
10.2. SURVIVAL.
(a) Effect of Termination or Expiration of Exclusivity Period . Unless otherwise agreed in writing by the Parties, and notwithstanding any other provision herein to the contrary, termination of this Agreement will have no impact or effect on the Parties rights and obligations with respect to any Development IP vested in the Company or any license agreement that is entered into between or among any of the Parties prior to the date of the termination of this Agreement or expiration of the Exclusivity Period.
(b) Surviving Provisions . The obligations of the Parties under this Agreement will survive the expiration or termination of this Agreement to the extent necessary to carry out the purposes of this Agreement, including without limitation, payment obligations under ARTICLE 6 , confidentiality obligations under ARTICLE 12 , liabilities and indemnification obligations under ARTICLE 14 and applicable miscellaneous provisions under ARTICLE 15 .
ARTICLE 11
RELATIONSHIP BETWEEN THE PARTIES
11.1. INDEPENDENT CONTRACTORS. The relationship between the Parties established under this Agreement is that of independent contractors and no Party is an employee, agent, partner, or joint venturer of or with another. No Party will have any express or implied power or authority to enter into any contracts or commitments or to incur any liabilities in the name of, or on behalf of, any other Party, or to bind any other Party in any respect whatsoever. Each of Hutchison and
Nestlé will be solely responsible for any and all salaries and other compensation, employment-related taxes, insurance premiums and other employment benefits respecting its personnel and the personnel of its Affiliates and Subcontractors engaged to perform Research under this Agreement. The Company agrees to grant Hutchison and Nestlé personnel reasonable access to its sites, systems and information (subject to the provisions of confidentiality in ARTICLE 12 below) as necessary for Hutchison and Nestlé to perform their obligations hereunder.
11.2. SUBCONTRACTORS. Each of Hutchison and Nestlé may engage Subcontractors to perform all or any portion of its obligations under this Agreement with the prior written approval of the Company, such approval not to be unreasonably withheld or delayed. Any such Subcontractor will, prior to being engaged to perform any activities hereunder, agree in writing to be bound by confidentiality obligations at least as protective as the terms of ARTICLE 12 regarding confidentiality below; and provided, further, that Hutchison or Nestlé (as the case may be) will remain responsible for full performance of its obligations hereunder. Any references in this Agreement to Hutchison or Nestlé and the performance of Research by Hutchison or Nestlé (including but not limited to the general obligations set forth in ARTICLE 3 , standards of care relating to performance set forth in ARTICLE 8 , and limitations on liability and indemnification set forth in ARTICLE 14 ) will include Subcontractors so engaged by Hutchison or Nestlé and performance of Research by such Subcontractors on behalf of Hutchison or Nestlé, respectively.
ARTICLE 12
CONFIDENTIALITY
12.1. CONFIDENTIALITY. Each Party (the Receiving Party ) agrees to keep in strict confidence all Confidential Information that the other Party (the Disclosing Party ) provides, communicates or otherwise makes available to the Receiving Party and to protect the Confidential Information with the same degree of care normally used to protect its own Confidential Information of a similar nature. The Receiving Party will not disclose or allow disclosure of any Confidential Information to any Third Party and will not use any Confidential Information in any manner, except, in each case, for the purposes of implementing and enforcing this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement or any Ancillary Agreement, without the prior written consent of the Disclosing Party.
12.2. EXCEPTIONS. The restrictions and obligations set forth in Sections 12.1 , 12.5 and 12.6 will not apply to any Confidential Information:
(a) which is or becomes generally available to the public through no fault on the part of the Receiving Party;
(b) which is lawfully in the possession of the Receiving Party (other than pursuant to the terms of this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement, any Ancillary Agreement or any other related agreement), without restriction as to its disclosure, prior to the disclosure of such information by or on behalf of the Disclosing Party or the Company, as reasonably evidenced by appropriate documentation;
(c) which lawfully becomes available to the Receiving Party from a source other than the Disclosing Party and the Company without any duty as to confidentiality or non-use;
(d) which is independently developed or otherwise created by the Receiving Party (other than pursuant to the terms of this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement, any Ancillary Agreement or any other related agreement) without the use of any Confidential Information of the Disclosing Party, as reasonably evidenced by appropriate documentation; or
(e) which is required to be disclosed or provided to any court, government or regulatory body of competent jurisdiction (including any relevant securities exchange) (i) pursuant to any Applicable Laws, judgment, decree or order, (ii) as necessary to make regulatory filings and communications related to the Hutchison Compounds or any Products, or (iii) for the purpose of asserting or defending against any claims relating to Intellectual Property Rights, including, in particular, any action taken to protect and enforce Intellectual Property Rights; provided, however, that (x) any such information disclosed pursuant to this Section 12.2(e) will be disclosed only to the extent required by Applicable Laws, judgment, decree or order, (y) except with respect to required disclosure to tax authorities, the Party seeking to disclose or provide such information will give the other Parties prompt written notice of such requirement and fully cooperate with the other Parties so that the other Parties and/or the Company (as the case may be) may obtain reasonable assurances that confidential treatment will be accorded to such information, and (z) without limiting the generality of the foregoing, the Parties will use commercially reasonable efforts to ensure that, subject to Applicable Laws, the list of the Products is redacted from any copy of this Agreement, the Joint Venture Agreement, the Option Agreement, each License Agreement and any Ancillary Agreement required to be filed with any government or regulatory body.
12.3. ACCURACY OF CONFIDENTIAL INFORMATION. Each Party hereby acknowledges that the Confidential Information of the other Parties may still be under development, or may be incomplete, and that such information may relate to products that are under development or are planned for development. Except as specifically provided in Section 8.2 , no Party makes any representations regarding the accuracy of its Confidential Information.
12.4. REMEDIES FOR BREACH OF CONFIDENTIALITY OBLIGATIONS. The Parties acknowledge that it will be impossible to measure the damages that would be suffered by the other Parties if a Party fails to comply with this ARTICLE 12 and that in the event of any such failure, there may not be adequate remedies under Applicable Laws. Each Party will, therefore, be entitled in addition to any other rights and remedies to obtain specific performance by any other Party of the obligations under this ARTICLE 12 and to obtain immediate injunctive relief without having to post a bond. No Party will urge, as a defense to any proceeding for such specific performance or injunctive relief by any other Party for breach of this ARTICLE 12 , that the relevant Party has an adequate remedy under Applicable Laws.
12.5. MEASURES TO KEEP CONFIDENTIALITY. Each Party agrees that, prior to giving access to any Confidential Information to any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, advisors, consultants and agents, it will require each such Person to agree to be bound by all obligations of confidentiality and non-use under this ARTICLE 12 , and will take all reasonable steps and measures to ensure that each such Person will enter into a confidentiality undertaking to comply with and perform such obligations, in each case to the same extent as if they were direct parties to this Agreement.
12.6. SURVIVAL OF OBLIGATIONS. The obligations undertaken by the Parties under this ARTICLE 12 will survive the termination of this Agreement for any reason and will remain in
effect and be binding on the Parties for a period of ten (10) years after the termination of this Agreement; provided that to the extent any Confidential Information constitutes a trade secret, as defined in the U.S. Uniform Trade Secrets Act or any Applicable Laws, then the Receiving Party will keep such trade secret confidential until such time as the Confidential Information no longer qualifies as a trade secret under Applicable Laws.
ARTICLE 13
INTELLECTUAL PROPERTY RIGHTS
13.1. EXISTING OWNERSHIP RIGHTS UNAFFECTED. As among the Parties, each Party will own and retain all right, title and interest in its Background IP.
13.2. NO OTHER LICENSE. Except as expressly set out in this ARTICLE 13 , no Party will gain, by virtue of this Agreement, any rights of ownership or use of copyrights, patents, trade secrets, trademarks or any other Intellectual Property Rights owned by the other Parties.
13.3. OWNERSHIP OF NEW PRODUCTS, HUTCHISON COMPOUNDS AND INDS. Except as otherwise set forth in this Agreement, the Company will own all right, title and interest in and to (a) any and all inventions, developments or discoveries specific to a Hutchison Compound or Product made by Hutchison, Nestlé or each of their Affiliates employees, agents or independent contractors in connection with their activities under this Agreement, (b) any and all Patent Rights claiming any invention, development or discovery described in clause (a) of this Section 13.3 , and (c) any and all Know-How embodied by or in any invention, development or discovery described in clause (a) of this Section 13.3 . Hutchison and Nestlé will take any action reasonably required to vest in the Company title to all such inventions, developments, discoveries and Patent Rights ( Development IP ). For clarity, the Parties agree that the Company will own all right, title and interest in any Development IP in all fields and indications and not just the Research Field. For the avoidance of doubt, any inventions, developments or discoveries and any related Patent Rights or Know-How of a general nature which are made in connection with the Research, but which are not specific to a Hutchison Compound or Product ( Party IP ) will be owned by the Party who, or whose Affiliate, employee, agent or independent contractor made such invention, development or discovery. Each Party hereby grants and will cause its Affiliates to grant to the Company and its Affiliates a fully-paid up, perpetual non-exclusive license with the right to sublicense, to use, develop, have developed, manufacture, have manufactured, commercialize and have commercialized any Party IP so far as it is relevant to the Hutchison Compound or Product.
13.4. PATENTS; FURTHER ASSISTANCE. The Company may, at its sole discretion, file one or more applications for patents in relation to any Development IP. Hutchison and/or Nestlé will promptly execute and deliver any assignments, descriptions of other instruments as may be necessary or proper in the reasonable opinion of the Company to vest in the Company title to the Development IP and to enable the Company to obtain and maintain the entire right and title to the Development IP throughout the world. Hutchison and Nestlé will also render to the Company, at the Companys expense, such assistance as the Company may reasonably require in the preparation and prosecution of applications for patents in connection with its Development IP, and in any litigation in which the Company may be involved relating to its Development IP.
ARTICLE 14
LIABILITY AND INDEMNIFICATION
14.1. LIABILITY FOR LOSS. Except (a) with respect to Liability arising from any willful misconduct or grossly negligent act of a Party or any of its Affiliates, (b) to the extent such Party may be required to indemnify any Hutchison Indemnified Party, Nestlé Indemnified Party or Company Indemnified Party (as the case may be) from and against any Liability to one or more Third Parties under this ARTICLE 14 , (x) in no event will any Party, any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, agents or representatives be liable under this Agreement for any special, indirect, incidental, consequential, punitive or exemplary damages, whether in contract, warranty, tort, negligence, strict liability or otherwise, including loss of profits or revenue suffered by any Party, any of its Affiliates or any of its or such Affiliates respective directors, officers, employees, agents or representatives and (y) Hutchisons or Nestlés Liability for damages arising out of the conduct of the Research hereunder will not exceed [**].
14.2. FORCE MAJEURE. Each of Hutchison and Nestlé will be excused from the performance of its obligations under this Agreement to the extent that such performance is prevented by Force Majeure provided that Hutchison or Nestlé (as the case may be) promptly provides notice of the prevention to the Company. Such excuse will be continued so long as the condition constituting Force Majeure continues and Hutchison or Nestlé (as the case may be) takes commercially reasonable efforts to remove the condition.
14.3. COMPANY INDEMNIFICATIONS. The Company will indemnify, defend and hold harmless all Hutchison Indemnified Parties and Nestlé Indemnified Parties from and against all Liabilities resulting from or arising out of:
(a) any claims of any nature arising out of the development, manufacture, commercialization or use of any and all inventions, developments or discoveries made by Hutchison, Nestlé or each of its Affiliates employees, agents or independent contractors in connection with their activities under this Agreement, on behalf of, or under the authority of, the Company (other than by any Hutchison Indemnified Party or Nestlé Indemnified Party), including but not limited to (i) government claims, (ii) product liability claims, and (iii) Intellectual Property claims, but excluding claims for which Hutchison or Nestlé is required to indemnify any of the Company Indemnified Parties pursuant to Section 14.4 or Section 14.5 herein respectively;
(b) any negligent or intentional act or omission of (i) the Company, (ii) any other Company Indemnified Party or (iii) any Third Party contractor engaged by the Company to perform activities under this Agreement for which the Company is responsible, in the course of or in connection with the performance of its obligations hereunder; or
(c) the breach by the Company of any of its representations, warranties or covenants, or any other provisions of this Agreement;
except, in each case, to the extent caused by the negligent or intentional acts or omissions of (x) Hutchison, any other Hutchison Indemnified Party or any Subcontractor or any of its employees, officers, directors or agents or by the breach by Hutchison of any of its representations, warranties or covenants set forth in this Agreement or (y) Nestlé, any other Nestlé Indemnified Party or any Subcontractor or any of its employees, officers, directors or agents or by the breach
by Nestlé of any of its representations, warranties or covenants set forth in this Agreement. For the avoidance of doubt, the Company will in no event be liable to any Hutchison Indemnified Party or Nestlé Indemnified Party for or in respect of any diminution in value of its equity or ownership interest in the Company that may result from, arise out of or be caused by any breach by the Company of its obligations to perform activities in compliance with Applicable Laws under Section 8.4 or as required by the other provisions of this Agreement.
14.4. HUTCHISON INDEMNIFICATIONS. Hutchison hereby agrees to indemnify, defend, and hold harmless any Company Indemnified Party or Nestlé Indemnified Party from and against any and all Liabilities resulting from or arising out of:
(a) any negligent or intentional act or omission of (i) Hutchison, (ii) any other Hutchison Indemnified Party or (iii) any Subcontractor or any of its employees, officers, directors or agents in the course of or in connection with the performance of the Research hereunder; or
(b) the breach by Hutchison of any of its representations, warranties, or covenants or any other provisions of this Agreement,
except, in each case, to the extent caused by the negligent or intentional acts or omissions of (x) the Company, any other Company Indemnified Party or any Third Party contractor engaged by the Company to perform activities under this Agreement for which the Company is responsible or by the breach by the Company of any of its representations, warranties or covenants set forth in this Agreement or (y) Nestlé, any other Nestlé Indemnified Party or any Subcontractor or any of its employees, officers, directors or agents or by the breach by Nestlé of any of its representations, warranties or covenants set forth in this Agreement.
14.5. NESTLÉ INDEMNIFICATIONS. Nestlé hereby agrees to indemnify, defend, and hold harmless any Company Indemnified Party or Hutchison Indemnified Party from and against any and all Liabilities resulting from or arising out of:
(a) any negligent or intentional act or omission of (i) Nestlé, (ii) any other Nestlé Indemnified Party or (iii) any Subcontractor or any of its employees, officers, directors or agents in the course of or in connection with the performance of the Research hereunder; or
(b) the breach by Nestlé of any of its representations, warranties, or covenants or any other provisions of this Agreement,
except, in each case, to the extent caused by the negligent or intentional acts or omissions of (x) the Company, any other Company Indemnified Party or any Third Party contractor engaged by the Company to perform activities under this Agreement for which the Company is responsible or by the breach by the Company of any of its representations, warranties or covenants set forth in this Agreement or (y) Hutchison, any other Hutchison Indemnified Party or any Subcontractor or any of its employees, officers, directors or agents or by the breach by Hutchison of any of its representations, warranties or covenants set forth in this Agreement.
14.6. INSURANCE. Each of Hutchison and Nestlé will maintain insurance with respect to its activities hereunder. Such insurance will be in such amounts and subject to such deductibles as are customary based upon standards prevailing in the industry at the time.
ARTICLE 15
MISCELLANEOUS
15.1. ENTIRE AGREEMENT. This Agreement constitutes the entire agreement between the Parties with respect to the subject matter of the Agreement. This Agreement supersedes all prior agreements, whether written or oral, with respect to the subject matter hereof. Each Party confirms that it is not relying on any representations, warranties or covenants of any 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 Appendices referred to in this Agreement are intended to be and are hereby specifically incorporated into and made a part of this Agreement.
15.2. FURTHER ASSURANCE. Each Party will perform all further acts and things and execute and deliver such further documents as may be reasonably necessary or as any other Party may reasonably require to implement or give effect to this Agreement.
15.3. WAIVER AND NON-EXCLUSION OF REMEDIES. A Partys failure to enforce, at any time or for any period of time, any provision of this Agreement, or to exercise any right or remedy will 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. The rights and remedies provided herein are cumulative and do not exclude any other right or remedy provided by law or otherwise available except as expressly set forth herein.
15.4. NOTICES. Any notice, request, demand, waiver, consent, approval or other communication permitted or required under this Agreement will be in writing, will refer specifically to this Agreement and will be deemed given only if delivered by hand or sent by facsimile transmission (with transmission confirmed) or by internationally recognized overnight delivery service that maintains records of delivery, addressed to the Parties at their respective addresses specified in this Section 15.4 or to such other address as the Party to whom notice is to be given may have provided to the other Parties in accordance with this Section 15.4 . Such Notice will be deemed to have been given as of the date delivered by hand or transmitted by facsimile (with transmission confirmed) or on the second (2) Business Day (at the place of delivery) after deposit with an internationally recognized overnight delivery service. This Section 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.
All correspondence to the Company will be addressed as follows:
Nutrition Science Partners Limited
22/F Hutchison House
10 Harcourt Road
Central
Hong Kong
Attn: The General Manager
Fax: +852 2128 1778 With a copy to:
The Finance Director
c/o Nestlé Health Science S.A. Avenue Nestlé 55, 1800 Vevey Switzerland
Attn: General Counsel
All correspondence to Hutchison will be addressed as follows:
和 记黄埔医药有限公司 Hutchison MediPharma Limited
Building 4, 720 Cailun Road
Zhangjiang High Tech Park
Shanghai, China 201203
Attn: Chief Executive Officer
Fax: +86 21 5079 3900
With a copy to:
Hutchison Whampoa Limited
22/F Hutchison House
10 Harcourt Road
Central
Hong Kong
Attn: Head Group General Counsel & Company Secretary
Fax: +852 2128 1778
All correspondence to Nestlé will be addressed as follows:
Nestlé Health Science S.A.
Avenue Nestlé 55, 1800 Vevey
Switzerland
Attn: President and Chief Executive Officer
With a copy to:
Nestlé Health Science S.A.
Avenue Nestlé 55
1800 Vevey
Switzerland
Attn: General Counsel
15.5. ASSIGNABILITY. This Agreement and each and every covenant, term and condition hereof will be binding upon and inure to the benefit of the Parties hereto and their respective successors and permitted assigns. Neither this Agreement nor any rights or obligations hereunder may be assigned, delegated or transferred, directly or indirectly, by a Party to any Third Party without the prior written consent of the other Party. The restrictions set out in this Section 15.5 will not apply
to any assignment of this Agreement by Nestlé or Hutchison to an Affiliate. Any attempted assignment or delegation in violation of this Section 15.5 will be void.
15.6. AMENDMENTS. Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of each of the Parties.
15.7. GOVERNING LAW. The interpretation and construction of this Agreement will be governed by the laws of England and Wales.
15.8. DISPUTE RESOLUTION. In the event of a dispute arising out of or relating to this Agreement, (including regarding its existence, termination or validity) (a Dispute ) any Party will provide written notice of the Dispute to the other Parties, in which event the Dispute will be referred to the executive officers of the Shareholders designated below or their successors. The designated officers will use reasonable efforts to attempt resolution by good faith negotiations within [**] days after such notice is received. Said designated officers are initially as follows:
和记黄埔医药 ( 上海 ) 有限公司 Hutchison MediPharma Limited: Chief Executive Officer
Nestlé Health Science S.A.: President and Chief Executive Officer
Company: The General Manager and the Finance Director
In the event the designated executive officers do not resolve such Dispute within the allotted [**] days, any Party may, after the expiration of the [**] day period, seek to resolve the Dispute through reference to arbitration in accordance with Section 15.9 . Notwithstanding the preceding, the Parties acknowledge that the failure of the Parties to reach consensus as to any matter, which failure does not involve a breach by a Party of its obligations hereunder, will not be deemed a Dispute which may be referred for resolution by the Parties under this Section 15.8 .
15.9. ARBITRATION: All Disputes which are unresolved pursuant to Section 15.8 and which a Party wishes to have resolved will be referred upon the application of any Party to, and finally settled by, arbitration in accordance with the ICC Arbitration Rules (the Rules ) as in force at the date of this Agreement and as modified by this Section 15.9 , which Rules are deemed incorporated into this Section 15.9 . The number of arbitrators will be three (3), one of whom will be appointed by Hutchison and one of whom will be appointed by Nestlé and the third of whom, who will act as chairman, will be nominated by the two party nominated arbitrators, provided that if the third arbitrator has not been nominated within [**] Business Days of the nomination of the second party nominated arbitrator, such third arbitrator will be appointed by the ICC. The seat of arbitration will be London and the language of arbitration will be English.
The arbitrators will have the power to grant any legal or equitable remedy or relief available under law, including injunctive relief (whether interim and/or final) and specific performance, and any measures ordered by the arbitrators may be specifically enforced by any court of competent jurisdiction. Each Party retains the right to seek interim or provisional measures, including injunctive relief and including pre arbitral attachments or injunctions, from any court of competent jurisdiction and any such request will not be deemed incompatible with the agreement to arbitrate or a waiver of the right to arbitrate. For the avoidance of doubt, this Section 15.9 is not intended to limit the powers of the court exercisable in support of arbitration proceedings pursuant to Section 44 of the Arbitration Act 1996 or any Applicable Law.
15.10. DISCREPANCY OF TERMS. Unless otherwise provided, in the event of any conflict or discrepancy between the terms of this Agreement and the terms of the Joint Venture Agreement, the latter will prevail unless otherwise specifically stated in this Agreement.
15.11. SEVERABILITY. To the fullest extent permitted by Applicable Laws, the Parties waive any provision of law that would render any provision in this Agreement invalid, illegal or unenforceable in any respect. If any provision of this Agreement is held to be invalid, illegal or unenforceable, in any respect, then such provision will be given no effect by the Parties and will not form part of this Agreement. To the fullest extent permitted by Applicable Laws and if the rights or obligations of any Party will not be materially and adversely affected, all other provisions of this Agreement will remain in full force and effect and the Parties will use their best efforts to negotiate a provision in replacement of the provision held invalid, illegal or unenforceable that is consistent with Applicable Laws and achieves, as nearly as possible, the original intention of the Parties.
15.12. EXECUTION IN COUNTERPARTS. This Agreement may be executed in any number of counterparts, each of which will be deemed an original and all of which taken together will be deemed to constitute one and the same instrument. An executed signature page of this Agreement delivered by facsimile transmission will be as effective as an original executed signature page.
15.13. NO BENEFIT TO OTHERS. The provisions of this Agreement are for the sole benefit of the Parties and their Affiliates, successors and permitted assigns, and they will not be construed as conferring any rights in any other Persons except as otherwise expressly provided in this Agreement. A Person who is not a Party will have no rights under the Contracts (Rights of Third Parties) Act 1999 to enforce any of the terms of this Agreement.
15.14. 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 in the event of any conflict in interpretation between the English version and such translation, the English version will prevail. English will be the official language of this Agreement and all communications between the Parties will be conducted in that language.
15.15. CONSTRUCTION. Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word or has the inclusive meaning represented by the phrase and/or. Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days. The headings of this Agreement and any descriptions of Appendices or descriptions of cross references are for convenience of reference only and do not define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement. The terms including, include(s), such as, and for example as used in this Agreement mean including the generality of any description preceding such term and will be deemed to be followed by without limitation.
ARTICLE 16
DEFINITIONS
The terms defined in this Article will have the meanings ascribed to them herein whenever they are used in the Agreement, unless otherwise clearly indicated by the context. Any capitalized terms used in this Agreement and not defined in this ARTICLE 16 will have the meaning ascribed to them in the Joint Venture Agreement and any reference to Party or Parties in such defined terms will be interpreted as a reference to a Party or the Parties to this Agreement.
16.1. Background IP will mean any Intellectual Property Controlled by a Party prior to the Effective Date or, any Intellectual Property Controlled by a Party that is not Development IP, whether protectable or not in the US or abroad by Intellectual Property Rights.
16.2. Company Indemnified Party will mean the Company, each of its Affiliates and each of its, its Affiliates respective employees, officers, directors and agents.
16.3. Development IP will have the meaning set forth in Section 13.3 .
16.4. Dispute will have the meaning set forth in Section 15.8 .
16.5. Effective Date will have the meaning set forth in the introduction to this Agreement.
16.6. Exclusivity Grant will have the meaning set forth in Section 3.4(a) .
16.7. Exclusivity Period will mean the Initial Exclusivity Period and any extensions of such period in accordance with Section 3.5 .
16.8. Force Majeure will mean an event that is beyond a non-performing Partys reasonable control, including an act of God, strike, lock-out or other industrial/labor dispute not solely involving the non-performing Partys own employees, war, riot, civil commotion, terrorist act, malicious damage, epidemic, quarantine, fire, flood, storm, natural disaster or compliance with any law or governmental order, rule, regulation or direction, whether or not it is later held to be invalid or inapplicable.
16.9. FTE means full-time equivalent, or the equivalent of a full-time employees work time.
16.10. FTE Rate will have the meaning set forth in Appendix 1 .
16.11. Hutchison Compounds will have the meaning set out in the Joint Venture Agreement, provided that Hutchison Compounds as used in this Agreement will not include any compounds containing HMPL-004.
16.12. Hutchison Indemnified Party will mean Hutchison, each of its Affiliates, and each of its and its Affiliates respective employees, officers, directors and agents.
16.13. Impracticability will mean the inability of Hutchison or Nestlé (as the case may be) to conduct a Research activity because such performance is Impracticable.
16.14. Impracticable will mean circumstances in which Hutchison or Nestlé (as the case may be) is unable to conduct a Research activity as a result of a cause or causes beyond the reasonable control of Hutchison or Nestlé (as the case may be) (including Force Majeure or scientific impossibility) or because the performance of such Research would require Hutchison or Nestlé (as the case may be) to violate any Applicable Laws or would result in the breach of any software license or other applicable contract by Hutchison or Nestlé (as the case may be), provided that such inability of Hutchison or Nestlé (as the case may be) was not the result of the fault or negligence of Hutchison, Nestlé and/or any of its Affiliates (as the case may be) and Hutchison, Nestlé and/or any of its Affiliates (as the case may be) have been unable to overcome such inability with the exercise of due diligence (including the expenditure of reasonable sums). For the purposes of clarity, where Hutchison or Nestlé (as the case may be) is unable to conduct a Research activity as a result of any non-performance by the Company of its obligations hereunder, such Research activity will also be deemed Impracticable for so long as the Company fails to cure such non-performance.
16.15. IND will mean investigational new drug.
16.16. Invoice Dispute will mean a dispute over an amount due on an invoice delivered pursuant to this Agreement.
16.17. Invoice Dispute Escalation Notice will mean written notice provided by a Party to the other Party referring a Dispute to the respective officers of the Parties for resolution, if resolution could not be made by the Parties themselves pursuant to Section 6.4(c) .
16.18. Joint Venture Agreement will have the meaning set forth in the recitals.
16.19. Know-How will mean any invention, discovery, trade secret, data, information, process, method, technique, material (including any chemical or biological material), technology, result, cell line, compounds, probe, sequence or other know-how, whether or not patentable.
16.20. Liability will mean any and all Third Party claims, suits, losses, liabilities, damages, costs, fees and expenses, including reasonable attorneys fees and expenses of litigation incurred by any Hutchison Indemnified Party, Nestlé Indemnified Party or any Company Indemnified Party (as applicable) in connection therewith.
16.21. Materials and Third Party Costs will have the meaning set forth in Section 6.1 .
16.22. Nestlé Indemnified Party will mean Nestlé, each of its Affiliates and each of its and its Affiliates respective employees, officers, directors and agents.
16.23. Notice of Invoice Dispute will mean written notice of an Invoice Dispute not resolved in the normal course of business, given by a Party to the other pursuant to Section 6.4(c) .
16.24. Party or Parties will mean any or all of Hutchison, Nestlé and the Company.
16.25. Party IP will have the meaning set forth in Section 13.3 .
16.26. Person will 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 or department or agency of a government.
16.27. Products will have the meaning set out in the Joint Venture Agreement; provided that Products as used in this Agreement will not include any products containing HMPL-004.
16.28. Research will mean the activities to be conducted by the Parties pursuant to the Research Plan.
16.29. Research Annual Budget means the annual budget approved by the Board of the Company detailing the projected costs for a calendar year of the Company under this Agreement, as updated and amended from time to time.
16.30. Research Collaboration Subcommittee will have the meaning set forth in Section 4.1 .
16.31. Research Field means, unless otherwise agreed between the Parties, the field in which research on Hutchison Compounds (excluding HMPL-004) will be conducted as determined by the Parties, including (without limitation) the treatment, prevention or diagnosis of gastrointestinal diseases, disorders or conditions in humans and, subject to the terms of this Agreement, if agreed by the Parties, brain health and metabolic health.
16.32. Research Plan means the research plan as set out in Appendix 1 .
16.33. Subcontractor will mean any Person (other than an Affiliate of Hutchison or Nestlé) engaged by Hutchison or Nestlé pursuant to Section 11.2 to conduct Research hereunder on behalf of Hutchison or Nestlé, as the case may be.
16.34. US means the United States of America.
16.35. US$ will mean the lawful currency of the United States of America.
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be executed in duplicate originals by its duly authorized representative.
和 记黄埔医药 ( 上海 ) 有限公司 Hutchison MediPharma Limited
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By: Christian Hogg
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Nestlé Health Science S.A. |
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By: Luis Cantarell
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Nutrition Science Partners Limited |
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By: Christian Hogg
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SIGNATURE PAGE TO RESEARCH AND DEVELOPMENT COLLABORATION AGREEMENT
Appendix 1
Research Plan
Scope: [**]
Objectives
[**]
[**]
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Deliverables: [**].
Covered Research & Development costs
Role of Hutchison: Under the Research Plan, Hutchison will [**].
FTEs: [**].
FTE Rate:
For Hutchison: [**].
Role of Nestlé: Nestlé will [**]
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FTE Rate:
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Additional costs
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Key Performance Indicators ( KPI s) for success: See deliverables and milestones in the respective sections.
Research & Development path: High level development plan
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Development Phase |
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Activities |
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Milestones |
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Time line: [**] |
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Step 2: [**]
Development Phase |
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Activities |
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Step 3: [**]
Development Phase |
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High Level Gantt Chart
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Detailed project path is to be established by the Research Collaboration Subcommittee upon discussion at the kick-off meeting.
Marked for SEC Redactions
[END OF DOCUMENT]
THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
English Translation
Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited
Equity Joint Venture Contract
November 28, 2004
Table of Contents
CHAPTER I DEFINITIONS |
4 |
CHAPTER II ESTABLISHEMENT OF THE JOINT VENTURE COMPANY |
7 |
CHAPTER III PURPOSE AND SCOPE OF BUSINESS OF THE JOINT VENTURE COMPANY |
9 |
CHAPTER IV TOTAL AMOUNT OF INVESTMENT AND REGISTERED CAPITAL |
10 |
CHAPTER V ASSIGNMENT OF INVESTMENT |
14 |
CHAPTER VI SPECIAL OBLIGATIONS OF THE PARTIES |
15 |
CHAPTER VII REPRESENTATIONS, WARRANTIES and UNDERTAKINGS |
17 |
CHAPTER VIII BOARD OF DIRECTORS |
23 |
CHAPTER IX MANAGEMENT ORGANIZATION |
29 |
CHAPTER X CERTIFICATES, APPROVALS AND TRADEMARKS |
31 |
CHAPTER XI SITE |
33 |
CHAPTER XII PURCHASE OF EQUIPMENT AND MATERIAL |
35 |
CHAPTER XIII CONTRACTING WITH THIRD PARTIES |
35 |
CHAPTER XIV LABOUR MANAGEMENT |
36 |
CHAPTER XV TAXATION |
37 |
CHAPTER XVI FINANCIAL AFFAIRS AND ACCOUNTING |
37 |
CHAPTER XVII FOREIGN EXCHANGE CONTROL |
39 |
CHAPTER XVIII EFFECTIVE DATE, TERM AND TERMINATION |
40 |
CHAPTER XIX LIQUIDATION AND DISPOSAL OF THE ASSETS OF THE JOINT VENTURE COMPANY |
42 |
CHAPTER XX INSURANCE |
44 |
CHAPTER XXI AMENDMENT OF THE CONTRACT |
44 |
CHAPTER XXII FORCE MAJEURE |
44 |
CHAPTER XXIII SETTLEMENT OF DISPUTES AND GOVERNING LAW |
45 |
CHAPTER XXIV CONFIDENTIALITY |
45 |
CHAPTER XXV BREACH OF CONTRACT |
46 |
CHAPTER XXVI GENERAL PROVISIONS |
46 |
CHAPTER XXVII APPENDICES |
47 |
Equity Joint Venture Contract
T HIS EQUITY JOINT VENTURE CONTRACT (this Contract) is jointly signed in Guangzhou, the Peoples Republic of China on this 28 th day of November, 2004 by and between:
Party A: Guangzhou Baiyunshan Pharmaceutical Holding Co., Ltd., a company limited by shares duly established and existing under the laws of Peoples Republic of China and registered with Guangzhou Municipal Administration for Industry and Commerce, with its legal address at 88 Yunxiang Road, Tonghe Street, Baiyun District, Guangzhou, Guangdong Province, China.
Legal Representative of Party A and the authorized representative for this Contract:
Name: Mr. Xia Zemin
Facsimile: (86-20) 8706-3699
Title: Chairman
Nationality: Chinese
Party B: Hutchison Chinese Medicine (Guangzhou) Investment Limited, a limited liability company duly established and existing under the laws of British Virgin Islands, with its legal address at P.O. Box 957, Offshore Incorporation Centre, Road Town, Tortola, British Virgin Islands. Party B is a wholly-owned subsidiary of Hutchison Whampoa (China) Ltd., with its communication address at Room 2108, Hutchison House, 10 Harcourt Road, Central, Hong Kong, facsimile: (852) 2810 0772.
The authorized legal representative for this Contract:
Name: Mr. Simon To Chi Keung
Title: Board Director
Nationality: British
Preamble
In accordance with the Law of the Peoples Republic of China on Sino-foreign Equity Joint Venture Enterprises , the Implementation Rules of Peoples Republic of Chinas Sino-foreign Joint Venture Enterprise Law and other applicable laws and regulations of the Peoples Republic of China, the aforesaid Parties, adhering to the principles of equality and mutual benefit and through friendly consultations, agree to form a Sino-foreign joint venture company on the following terms and conditions in Guangzhou, the Peoples Republic of China.
CHAPTER I
DEFINITIONS
As required by the serious and precise nature of contracts, this Contract contains a large quantity of terms and industry-specific terminologies. For the avoidance of any doubt, certain terms are construed and interpreted in this Chapter. In case the following interpretations of the terms are in conflict with the interpretations provided in the current PRC laws and regulations, the interpretations provided in the current PRC laws and regulations shall prevail.
1.1. Subsidiary shall mean any company which directly, or indirectly controlled by any Party of this Contract. Control shall mean having, directly or indirectly, more than fifty percent (50%) of the interests or controlling power or management power.
1.2. Affiliate shall mean any company which controls or is controlled by or under common control with any Party hereto. Control shall have the meaning ascribed to it in Section 1.1 hereof.
1.3. Associate Company shall mean any company in which any Party holds, directly or indirectly, greater than 20% but less than 50% of equity interests.
1.4. Parties hereto or Parties shall mean Party A and Party B. Party hereto or Party shall mean Party A or Party B, as the context may require.
1.5. Investing Party or Investing Parties shall mean Party A or Party B or both Party A and Party B, as the context may require.
1.6. JVC shall mean Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited, which is duly registered and established by the Investing Parties in Guangzhou, PRC according to the Contract.
1.7. Contract Products or JVC Products shall mean the products Party A transfers to the JVC according to the Contract.
1.8. Varieties shall have the basic meaning ascribed to it under the Regulations on the Protection of Varieties of Traditional Chinese Medicines and also include part or all of the followings (if applicable): national standards (which shall have the same meaning with national drug standards as defined in The Drug Administration Law of the Peoples Republic of China) of a certain pharmaceutical variety, prescription, form of dosage, relevant patents, copyright and other intellectual property rights, manufacturing practices or processes, as well as other related technical data and information. Variety can be any one of the following types:
(1) patented varieties: means the varieties of drugs for each of which a certificate of patent has been granted;
(2) protected varieties: means the the varieties of drugs for each of which a certificate of variety of Chinese traditional medicine under protection has been granted, including Class I protected varieties, Class II protected varieties and any other classes of protected varieties;
(3) varieties of drugs that have achieved national drug standards or drug standards of provinces, autonomous regions or municipalities;
(4) new drugs: means the varieties of drugs for each of which a new drug certificate has been granted;
(5) varieties of drugs for which the China drug approval numbers have been issued;
(6) any other varieties of drugs that satisfy the standards of China Pharmacopoeia or China national drug standards; and
(7) other varieties of drugs, healthcare products, foods, Chinese herbal medicines that are recognized by the JVC and approved by relevant governmental authorities.
1.9. Investment shall mean the actual capital contributions paid by the Parties to the JVC and the Parties ownership percentage in the JVC in proportion to their contributions to the capital.
1.10. TCM Factory shall mean Guangzhou Baiyunshan Traditional Chinese Medicine Factory under Guangzhou Baiyunshan Pharmaceutical Holding Co., Ltd. which is wholly owned by Party A (except for the part in connection with the external use drugs).
1.11. Two Certificates shall mean the Pharmaceutical Manufacturing Permit and the GMP certificate for drugs.
1.12. Articles of Association shall mean the Articles of Association of the JVC.
1.13. Board of Directors or Board shall mean the Board of Directors of the JVC consisted of the directors nominated by the Investing Parties hereto.
1.14. Effective Date shall mean the approval date specified in the approval certificate issued by the relevant PRC governmental authority upon the approval of this Contract and the Appendices hereto.
1.15. Date of Establishment shall mean the date of issuance of the JVCs business license.
1.16. Closing Date shall mean the date on which Party A transfers the assets and the business of TCM Factory to the JVC. Such date shall be confirmed in writing by the Parties after the issuance of the official business license of JVC. Prior to the Closing Date, Party A owns the rights and assumes liabilities with respect to the asset and business of TCM Factory to be transferred by Party A to the JVC. After the Closing Date, the JVC owns the rights and assumes liabilities with respect to the assets and the business of TCM factory.
1.17. Approval Authority shall mean the Ministry of Commerce of the PRC and any other government authorities or their authorized delegates, the approval from which is required by the laws of the Peoples Republic of China.
1.18. SASAC shall mean State-owned Assets Supervision and Administration Commission of the State Council or any state-owned assets administration authority authorized thereby.
1.19. Joint Venture Term shall mean the term set forth in Section 18.2 hereunder or that term as may be extended or shortened pursuant to Section 18.2 or Section 18.4 hereunder.
1.20. Party As Assets shall mean the tangible or intangible assets listed in an appraisal report issued by an appraisal firm recognized by both Parties (including the buildings, structures, production facilities and other assets confirmed by both Parties that are located on the Sites and at any other locations), which shall be acquired by the JVC pursuant to this Contract. A description of Party As Assets to be transferred to the JVC and the appraised value thereof are set out in Appendix A hereto.
1.21. TCM Factory Business shall mean the normal business operations of TCM Factory to manufacture and sell the products listed in the Appendix I hereto in accordance with its business license, Two Certifications and Product Certificate or Product Approval
1.22. TCM Factory Contracts shall mean the contracts concluded by TCM Factory which the JVC must continue to perform. The basic terms and conditions of such contracts are set forth in Appendix B hereto.
1.23. Renminbi or RMB shall mean the lawful currency of the PRC.
1.24. U.S. Dollar or USD shall mean the lawful currency of the United States
1.25. SAFE shall mean the State Administration of Foreign Exchange of the PRC or its Guangdong Province branch.
1.26. Sites shall mean the plots of land and areas in Guangzhou Municipality, the land use right over which will be transferred the JVC hereunder for the duration of the Joint Venture Term. The site map showing the location and boundaries of the site and relevant documents are attached hereto as Appendix C.
1.27. Product Certificate or Product Approval shall mean the state new drug certificate or product approvals.
1.28. Personnel shall mean all workers and other staff (except for the Board directors and senior executives) of the JVC, including the seconded employees assigned by either Party.
1.29. PRC shall mean the Peoples Republic of China.
1.30. PRC Laws or Laws of China shall mean the legal and effective laws, regulations and administrative rules officially promulgated by the government of the PRC.
1.31. Hong Kong shall mean Hong Kong Special Administrative Region of the Peoples Republic of China.
1.32. this Contract or the Contract shall mean the main body of this Joint Venture Contract of Hutchison Whampoa Guangzhou Baiyunshan Chinese Medicine Company Limited and all appendices thereto.
CHAPTER II
ESTABLISHEMENT OF THE JOINT VENTURE COMPANY
2.1. In accordance with the Law of Peoples Republic of China on Sino-foreign Equity Joint Venture Enterprises, the Implementation Rules of Peoples Republic of Chinas Sino-foreign Joint Venture Enterprise Law and other relevant PRC Laws, the Parties, adhering to the principles of equality and mutual benefit and through friendly consultations, agree to form a Sino-foreign joint venture company in Guangzhou, China.
2.2. The name of the JVC is 广州白云山和 记 黄埔中 药 有限公司 in Chinese and HUTCHISON WHAMPOA GUANGZHOU BAIYUNSHAN CHINESE MEDICINE COMPANY LIMITED in English.
2.3. The legal address of the JVC is 389 North Shatai Road, Guangzhou, Guangdong Province, PRC.
2.4. The JVC shall apply for registration with the Guangzhou Municipal Administration for Industry and Commerce of the PRC. The JVC is a corporate legal person in China. All activities in China of the JVC shall be conducted in compliance with PRC Laws and be governed and protected by the laws of the Peoples Republic of China.
2.5. The JVC shall be an independent entity and entitled to all preferential treatment granted to Sino-foreign joint venture enterprises by the PRC governments at various levels.
2.6. The JVC shall be a limited liability company. The liability of the Investing Parties shall be limited to the amounts of their respective capital contribution. The JVC shall bear liabilities with all its assets.
2.7. The profits, risks, and losses shall be shared by the Investing Parties in proportion to their respective ownership percentage (50%:50%) on the condition that a) Party A has delivered to the JVC the assets listed in the Appendix A hereto and the TCM Factory Business, and maintained its normal operation; and b) Party B has fulfilled its obligations of making capital contribution and providing shareholder loans according to Appendix E hereto. The date of sharing such profits, risks and losses shall commence on the Closing Date. Any Party who fails to perform the aforesaid obligations shall not be entitled to participate in any profit sharing.
2.8. The JVC shall have full autonomy in its business operations and have the right to decide on its business strategies in accordance with its own best interests.
2.9. The JVC shall fulfill the TCM Factory Contracts, the basic terms and conditions of which are listed in Appendix B hereto. Party A guarantees that relevant documents and information provided by it in Appendix B A hereto are complete, true and valid. The JVC shall fulfil contracts executed by TCM Factory that are not included in Appendix B, provided that such fulfilment will not exert any adverse impact on the JVC or expose the JVC to any risk.
CHAPTER III
PURPOSE AND SCOPE OF BUSINESS
OF THE JOINT VENTURE COMPANY
3.1. The purpose of the JVC shall be, through the joint venture of both Parties, to strengthen the economic cooperation and technology communications, to develop and improve the modernization of the traditional Chinese medicine industry, to promote the development of traditional Chinese medicine business; to use advanced technologies, equipment and devices to absorb the advanced management experience and method from abroad, so as to bring satisfactory economic benefits to the Parties.
3.2. Subject to the final approval of the competent governmental authority, the scope of business of the JVC shall be to manufacture, process, research and develop various drugs, healthcare products, foods and Chinese herbal medicines, and sell the self-manufactured products (except for those listed in the prohibited categories in the Catalogue for the Guidance of Foreign-invested Industry ) .
3.3. The JVC shall purchase and sell the products in a fair competitive manner at a market price. The JVC shall not engage in operating products in violation of the non-compete agreement to which Party A or Guangzhou Pharmaceutical Group Company Limited is a party.
3.4. The Parties agree that the JVC shall, from the Varieties with Production Approval provided by Party A, select the profitable Varieties that meet market demand for production and sale. Appendix I hereto lists the Varieties provided by Party A to the JVC. The JVC shall accelerate the research and development of the new products itself, and put into production as soon as possible according to the market conditions.
3.5. Party A agrees to transfer to the JVC its equity interest in Anhui Haozhou Baiyunshan Pharmaceutical Company Limited and Anhui Fuyang Baiyunshan Radix Isatidis Technology Development Company Limited at a price based on valuation. The Parties agree that, the JVC will conduct in-depth research on the above project, and according to the feasibility report, decide its business strategies at its own discretion without violating PRC Laws.
CHAPTER IV
TOTAL AMOUNT OF INVESTMENT
AND REGISTERED CAPITAL
4.1. The total amount of investment of the JVC shall be [**].
4.2. The registered capital of the JVC shall be [**].
4.3. The capital contribution of each Party and their ownership percentage shall be as follows:
(1) Party As contribution to the JVC s registered capital shall be [**], representing fifty percent (50%) of the registered capital; and
(2) Party Bs contribution to the JVCs registered capital shall be in US dollar or HK dollar in an amount equivalent to [**], representing fifty percent (50%) of the registered capital.
4.4. Each Party shall make its capital contribution and provide or raise funds as follows:
(1) Party A and Party B shall make capital contributions in the following ways according to the provisions of Section 4.5 to 4.7 hereof:
Party A shall, pursuant to the contribution schedule listed in Appendix E attached hereto, make an in-kind contribution of assets (including tangible and intangible assets as set forth in Appendix A hereto) and TCM Factory Business related to the assets which are valued at [**] in total.
Party B shall make a cash contribution of an amount in HK dollar or US dollar equivalent to [**].
Either Partys failure to make its contribution on time or in full in accordance with the provisions hereof would constitute a breach of the Contract. The non-defaulting Party shall have the right to demand the defaulting Party to make its contribution in full within one (1) month (the Extended Period ). If the defaulting Party fails to make its contribution in its entirety within the Extended Period, the non-defaulting Party shall have the right to apply with the original Approval Authority for approval to dissolve or liquidate the JVC within one (1) month from the due date of the Extended Period (When conducting such liquidation, the defaulting Party shall not have any
right or interest in the assets of the JVC which are contributed by the non-defaulting Party.)
(2) Both Parties shall provide or raise funds for the difference between the total investment amount and registered capital through shareholder loans or by other ways according to the following principles:
The Parties agree that, after the establishment of the JVC, the Parties shall provide funds totaling [**] to the JVC, of which, [**] shall be provided by Party A in the form of assets and [**] shall be provided by Party B in cash through shareholder loans. The Parties agree that each will assume and pay its own taxes and expenses incurred in connection with the provision of such funds.
In case either Party fails to provide the funds in accordance with the above provision, resulting in substantial impacts on the normal production and operation of the JVC, the non-defaulting Party shall have the right to terminate this Contract and liquidate the JVC by giving a notice to the other Party.
(3) The Parties agree that, if further registered capital is required for the business operation and development of the JVC, the Parties shall make additional contributions to the registered capital in proportion to their existing ownership percentage in the JVC. Subject to the unanimous approval of the Board of Directors, the Parties are obligated to make contributions to the increase in the registered capital.
(4) Subject to the unanimous approval of the Board of the Director on the amount and method of the additional financing, the JVC may obtain additional financing as follows:
(i) the JVC may obtain financing from banks or other financial institutions (the Lenders) and grant security over its assets as the Lenders may require. If the security provided by the JVC is not sufficient, then the Parties shall provide guarantees to the Lenders in proportion to their respective contribution to the registered capital of the JVC; or
(ii) the Parties may provide additional financial assistance to the JVC through shareholder loans or by other ways in proportion to their respective contribution to the registered capital of the JVC.
4.5. Subject to the satisfaction of each of the conditions precedent under Section 4.6 herein or waiver by mutual consent of the Parties of certain conditions precedent, the Parties shall make their contributions at the time specified in Section 4.7.
4.6. The Parties obligations to make contributions to the JVs are subject to the satisfaction of each of the following conditions precedent:
(1) a PRC- qualified assets appraisal firm recognized by both Parties has completed the assets appraisal on Party As Assets and delivered an assets appraisal report (the Appraisal Report) that is acceptable to both Parties. For the avoidance of any doubt, the Parties emphasize that, if this condition precedent is not satisfied, Party B shall not be obligated to make its contribution, and in addition, Party B shall have the right to terminate this Contract, and to exit and liquidate the JVC in accordance with provisions of Section 2 and Section 4.7(2) hereof;
(2) the competent SASAC has confirmed in writing without reservation the appraisal results of Party As Assets as specified in the Appraisal Report ;
(3) Party A has obtained the written consent from relevant banks or financial institutions regarding the contribution of Party As Assets to the JVC in accordance with the provisions hereof;
(4) Party As Board of Directors has adopted a resolution approving the execution of this Contract and Articles of Association of the JVC, and according to PRC Laws and the listing rules of Shenzhen Stock Exchange, Party A has made disclosures to, filings and registration with, or obtained approvals of relevant governmental authorities and any internal approvals and authorizations (if applicable), and adopted resolutions at shareholder meetings as required to execute the Contract and the Articles of the Association of the JVC;
(5) Party Bs Board of Directors has adopted a resolution approving the execution of this Contract and Articles of Association of the JVC, and Party B has obtained all internal approvals and authorization required to execute this Contract and Articles of the JVC;
(6) the Parties have executed this Contract and the Articles of Association of the JVC;
(7) the relevant Approval Authority has issued an official written reply, approving the establishment of the JVC, this Contract and the Articles of Association of the JVC;
(8) the relevant Approval Authority has issued the Foreign Investment Enterprise Approval Certificate to the JVC; and
(9) the relevant Administration for Industry and Commerce has issued the PRC Legal Entity Business License to the JVC (the Business License).
2. If any of the above conditions precedent is not fulfilled within three (3) months from the date of the issuance of the Business License, or not otherwise waived by parties in writing within thirty (30) days after the expiration of the above period of time, neither Party is obligated to make its capital contribution, and either party shall have the right to terminate this Contract. The failure to fulfill a conditions precedent (regardless of which Party is the responsible party) shall not be considered a breach of this Contract, and neither Party shall be held responsible for such failure, and the Parties shall have no right to recover any loss or pursue compensation from each other.
4.7. Each Party agrees to make its contribution to the registered capital in accordance with the following schedule:
(1) Starting from the issuance date of the Business License of the JVC and subject to the provisions of Section 4.6, each Party shall make its contribution according to the contribution schedule provided in Appendix E attached hereto.
(2) If any of the conditions precedent set forth in Section 4.6 is not fully satisfied within the period as provided in clause 2 of Section 4.6 or otherwise waived by both parties in writing, then this Contract shall be terminated according 4.6.2 and the JVC shall be liquidated according to the Contract.
4.8. After the JVC obtains the Business License, the JVC shall convene its first Board meeting according to the provisions of Section 8.4 and open a Renminbi bank accounts and a foreign currency bank account following the first Board meeting. After the opening of the bank accounts, each Party shall make its contribution to the JVC according to the contribution proportion in clause 2 of Section 4.3, the contribution methods in Section 4.4 and the contribution schedule in Section 4.7.
4.9. The exchange rate for conversion between RMB and foreign currencies shall be the middle exchange rate as published by Peoples Bank of China at the payment day for determining Party Bs cash contribution and shareholder loans.
4.10. After the Investing Parties have made their contributions, the JVC shall engage a PRC-qualified public accounting firm to verify the contributions and issue a capital verification report. On the basis of such capital verification report, the JVC shall issue investment share certificates to both Parties, which shall specify the name and the Date of Establishment of the JVC, the name of the Investing Party, the amount of contributions and date on which such contributions are made, and the date of issuance of the investment share certificates.
CHAPTER V
ASSIGNMENT OF INVESTMENT
5.1. Without the prior written consent of the other Party, neither party shall assign, sell or otherwise dispose of any part of its Investment to any third party.
5.2. If a Party agrees that the other Party (the Disposing Party) assigns its Investment, the Disposing Party shall inform the other Party of the terms and conditions of the proposed assignment in writing and the other Party shall have the right of first refusal.
5.3. If the other Party does not exercise its right of first refusal within three (3) month from the date of the receipt of the written notice, the Disposing Party can assign, sell or otherwise dispose of all or part of its Investment to any third party at the price and on terms not more favorable than those provided to the other Party. The Disposing Party shall provide the other Party with a copy of the written agreement signed with the purchaser/assignee.
5.4. Notwithstanding the foregoing, the Parties agree that Party A may assign all or part of its Investment to the Subsidiaries or Associate Companies of Guangzhou Pharmaceutical Group Company Limited, and Party B may assign all or part of Investment to the Subsidiaries or Associate Companies of Hutchison Whampoa Company Limited. The Parties hereby acknowledge and agree on such assignment and waive their right of first refusal, and will procure the Board of Directors to approve the above assignment. The assignor shall issue a document certifying that both the assignor and the assignee are
the Subsidiaries or Associate Companies of Guangzhou Pharmaceutical Group Company Limited or Hutchison Whampoa Company Limited.
5.5. The assignment of its Investment by any Party shall be subject to the following conditions:
(1) the assignee has signed the relevant written documents in the forms as reasonably requested by the other Party, whereby the assignee agrees to be bound by this Contract and enjoy interests and rights under the Contract as if it were an the original Party hereto; and
(2) the business of the JVC or the performance of its contracts must not be interrupted by the sale, assignment or other disposal of such Investment interests.
5.6. The sale, assignment or other disposal of the Investment shall be submitted the Approval Authority for approval as prescribed by PRC Laws. After obtaining the approval from the Approval Authority, the JVC shall file the registration of changes with Guangzhou Municipal Administration for Industry and Commerce.
The above provision does not apply to the situations described in Section 18.4 hereof.
5.7. Without the consent from the other Party, neither Party may pledge, mortgage or otherwise encumber all or any part of its equity interest in the JVC.
5.8. The Parties agree that, if any Party (the Seeking Listing Party) would restructure its equity in the JVC and form a company limited by shares with its equity in the JVC to seek listing on domestic or overseas stock exchange, the other Party shall provide support and cooperation to the Seeking Listing Party.
CHAPTER VI
SPECIAL OBLIGATIONS OF THE PARTIES
6.1. Party A shall:
(1) [**]
(2) [**]
(3) [**]
(4) [**]
(5) [**]
(6) [**]
(7) [**]
(8) [**]
(9) [**]
(10) [**]
(11) [**]
6.2. Party B shall:
(1) [**]
(2) [**]
(3) [**]
(4) [**]
(5) [**]
(6) [**]
CHAPTER VII
REPRESENTATIONS, WARRANTIES AND UNDERTAKINGS
7.1. For the purpose of this Contract, Party A unconditionally and irrevocably represents and warrants to Party B as follows:
(1) Party A is an enterprise duly incorporated and existing in accordance with PRC Laws and having an independent legal personality;
(2) Party A has the power and legal capacity to execute and perform this Contract and other documents related to the Contract, to which Party A is a party;
(3) Party A has taken all measures and obtained all authorizations required for executing this contract and all other documents to which Party A is a party;
(4) Party A has obtained from the competent PRC governmental authorities all approvals, consents, authorizations and permits required for executing this contract, the Articles of Association and the Appendices; and
(5) except as disclosed by Party A to Party B, Party A is the lawful owner of and has full and valid title to contribution made by Party A to the JVC, free and clear of any security, mortgage, pledge, lien and/or other encumbrance/debt of any kind in favor of any third party. No third
party is entitled to exercise any right or claim of any kind whatsoever over such assets.
7.2. For the purpose of the Contract, Party B unconditionally and irrevocably represents and warrants to Party A as follows:
(1) Party B is a limited liability company duly incorporated and existing in accordance with the laws of the place of its incorporation and having an independent legal personality;
(2) Party B has the power and legal capacity to execute and perform this Contract and other documents related to the Contract, to which Party B is a party;
(3) Party B has taken all measures and obtained all authorizations required for executing this contract and all other documents to which Party B is a party;
(4) Party B has obtained all approvals, consents, authorizations and permits required for executing this contract, the Articles of Association and the Appendices; and
(5) Party B is the lawful owner of and has full and valid title to contribution made by Party B to the JVC, free and clear of any security, mortgage, pledge, lien and/or other encumbrance of any kind in favor of any third party. No third party is entitled to exercise any right or claim of any kind whatsoever over such cash.
7.3. After mutual consultation, Party A or Party B unconditionally and irrevocably represents, warrants or undertakes as follows:
(1) the assets and liabilities of the TCM Factory to be transferred to the JVC as recognized by Party B shall be determined based on the Closing Audit Report (as defined below). Any rights and liabilities with respect to the TCM Factory that are not disclosed in the Closing Audit Report shall be owned, undertaken or settled by Party A, and the JVC shall not be involved therein;
(2) Party A and Party B shall engage a PRC-qualified public accounting firm to audit the balance sheet confirmed by Party A and Party B, and the audited financial statements shall serve as the basis for the general ledger of the JVC;
(3) considering a)the TCM Factory continues in business as a going concern; b)the balance sheet in Appendix (A) hereto solely reflects transaction price of the assets based on the appraisal; and c) there have been changes in the balance sheet from the appraisal date to the Closing Date after the establishment of the JVC, the Parties agree to appoint a PRC-registered public accounting firm to audit the financial statements of the TCM Factory for the period ended on the Closing Date, and issue an audit report (the Closing Audit Report). The JVC will prepare accounts based on the Closing Audit Report, compare them with the financial statements attached hereto as Appendix (A), calculate the differences between the value on the appraisal date and that on the Closing Date, and reconcile the accounts accordingly. Party A shall either make or receive a payment in cash to reconcile the differences with the goal of ensuring that the capital contribution made by each Party continue to represent 50% of the registered capital of the JVC;
(4) Party A warrants that all materials disclosed to Party B with respect to the assets and liabilities of the TCM Factory are complete, true and valid. Party A shall be liable to compensate all losses suffered by the JVC arising from any untrue statements provided by Party A;
(5) starting from the Date of Establishment of the JVC, Party A shall assist the JVC in counting, stocktaking and confirming the assets, and deliver to JVC all assets, documents and materials that the JVC shall be entitled to, and the JVC shall confirm to Party A the receipt of above in writing ;
(6) Party A warrants that a) the lands and factory buildings as well as all power, environmental protection and sewage facilities as party of Party As contribution to the JVC comply with the requirements and criteria imposed by the government and in good working conditions; and b) Party A has not received any instruction or other notices issued by any governmental authority, requiring Party A to change land use, or add, expand or remodel any facilities to fulfill regulatory requirements;
(7) in connection with the account receivable and other receivables confirmed by both Parties as listed on the balance sheet in the Closing Audit Report, Party A shall enter into contracts, agreements or acknowledgement statements with relevant enterprise and individual debtors (the Debtors), whereby the Debtors shall confirm the amount owned by them to the JVC and undertake to pay off the confirmed
amounts to the JVC within three (3) months after the Date of Establishment. The JVC may provide funds or loans to the Debtors later depending on the each case. Any amount that is not confirmed or paid by the Debtors will be removed from the balance sheet, and Party A will be responsible for collecting such amount for itself, and it shall pay the JVC, in cash, an amount equal to such amount to make up the balance;
(8) in connection with the account payable and other payables confirmed by both Parties as listed on the balance sheet in the Closing Audit Report, Party A shall enter into contracts, agreements or acknowledgement statements with relevant enterprise and individual creditors (the Creditors), whereby the Creditors shall confirm the amounts owed by the JVC to them. JVC shall make the payment to the Creditors within three months after the Date of Establishment. If Party A fails to have any amount confirmed and paid within three months after the Date of Establishment, such unconfirmed or unpaid amount will be removed from the balance sheet. Party A will be responsible for making the payment of the unconfirmed or unpaid amount, and the JVC shall pay Party A amount equal to such amounts in cash;
(9) the liabilities listed on the balance sheet confirmed by both Parties (i.e., the liabilities listed on Closing Audit Report) shall be the maximum amount (the Cap) that the JVC agrees to assume. Party A shall be responsible for handling or paying off any unrecorded liabilities or any liabilities that exceeds the Cap, and guarantee that the JVC will not assume any legal or economic liabilities or suffer any losses arising therefrom;
(10) Party A shall obtain the confirmation and approval of the transfer of the state-owned assets to the JVC from the competent SASAC;
(11) if the JVC needs to apply for bank loans due to operational demands, Party A agrees to assist the JVC in obtaining bank loans on conditions no less favorable than those offered to Party A;
(12) Party A shall be responsible for dealing with the legal and economic relationships and assume any liabilities related to its investment projects or tertiary industry projects (if any) that are not handed over to the JVC, so as to ensure under no circumstance, will the JVC be liable for any consequences in connection therewith;
(13) in connection with Party As in-kind contribution of inventory to the JVC, Party A warrants that (i) the inventory (including raw materials, finished drug products and packaging materials) is relevant to the product Varieties of the JVC (see Appendix 1 hereto); (ii) the raw materials and the non-medicinal ingredients comply with the quality standards and requirements; and (iii) no half-finished or finished Chinese medicine has reached it expiry date. Within one month after the establishment of the JVC, Party B may engage a provincial-level pharmaceutical research institute to examine the quality of the inventory as it deems necessary. Based on the pharmaceutical research institute testing result, any inventory that does not comply with the above requirements will not be counted as part of Party As contribution to the JVC. Party A may reduce its contribution to the JVC by an amount equals to the value of such unqualified inventory. If the testing result issued by the pharmaceutical research institute shows a quantity deviation within +/- 5 percent, Party B shall unconditionally accept such result without adjusting the accounts and assume the testing expenses payable to the pharmaceutical research institute. If the testing result shows a quantity deviation above +/- 5 percent, Party A shall pay or get paid for the amount exceeding +/- 5 percent within 10 days, and shall be responsible for the testing expenses;
(14) Party A undertakes that, after the Date of Establishment of the JVC, it shall procure the existing employees of the TCM Factory enter into employment contracts with the JVC. For the retired employees of the TCM Factory, the JVC shall make one-off payment of [**] to Party A to be used toward compensations and payment of benefits related to these employees, and thereafter Party A shall be responsible for settling any issue relating to the compensations and benefits with respect to the retired employees, and the JVC shall not be responsible therefor;
(15) Party A undertakes that it shall be responsible for all taxes (e.g. sales tax, value-added tax and income tax), employees taxes (including, without limitation, personal income tax), social welfare funds and other expenses incurred prior to the Closing Date that are not disclosed in the Closing Audit Report, except for any employee compensation and /or severance payment arising out of the termination of a labor contract with an employee. Under no circumstance, shall the JVC be held responsible for such taxes and expenses;
(16) Party A undertakes that starting from the Date of Establishment of the JVC, to ensure a steady transition of the JVC, it will assist the JVC with the day-to-day operation, procure the JVC to enter into relevant contracts with the distributors and the suppliers after the Closing Date, and maintain supply chain (including but not limited to raw materials, non-medicinal ingredients, packaging materials, semi-finished products) running smoothly;
(17) Party A shall endeavor to divest itself of all divestible liabilities and assets relating to the external medicines prior to the Closing Date. The Parties will consult with each other to resolve matters relating to the portions that are not divestible;
(18) Party A undertakes it will cease operating businesses or manufacturing any product in the name of the TCM Factory after the Closing Date. Party A shall carry out the deregistration procedures for the TCM Factory after the TCM Factory has transferred all certificates and approvals granted to it;
(19) Party A represents and warrants that it is the lawful owner of the Two Certificates of the TCM Factory, Product Certificates or Approvals of the TCM Factory, and the patents of the TCM Factory as set forth in Chapter 10 hereof, and no third party has raised or will raise any claim or objection in respect of such ownership. Party A is entitled to lawfully transfer these Two Certificates, Product Certificates or Approvals and patents of the TCM Factory to the JVC. Party A undertakes to carry out the formalities with respect to ownership transfer of these Two Certificates , Product Certificates or Approvals and patents of TCM Factory to the JVC with the PRC governmental authorities within one month after the Closing Date and to complete such formalities within 12 months. Party B may grant Party A an extension to perform such obligation in accordance with the actual situations;
(20) Party A guarantees that the JVC has the right to openly recruit employees in accordance with the development plans of the JVC; and
(21) the Parties hereby agree that Party A shall be responsible for all debts (except for the accounts payable listed in the Closing Audit Report that will be assumed by the JVC as agreed by Party B) and liabilities (including but not limited to any accident or liability related to the TCM Factory or any products of the TCM Factory that occurs or
commences prior to the Closing Date and that continues to exist after the Closing Date) incurred by Party A related to TCM Factory Contracts prior to the date on which the TCM Factory Contracts (see Appendix (B) hereto) are transferred to the JVC (the Closing Date), and under no circumstance, will the JVC be responsible for such debts or liabilities. Party A shall indemnity, reimburse and hold the JVC harmless from any losses (including legal proceedings and attorneys fees) incurred by the JVC arising out of or resulting from any third party claim or demand brought after the Closing Date against the JVC related to Party As above debts or liabilities. Party A shall be entitled to any benefits arising under TCM Factory Contracts relating to claims or rights incurred or brought against any third party by TCM Factory prior to the Closing Date. The JVC agrees to assist Party A in exercising or realizing such right or claim as and when needed. If the JVC receives any proceeds relating to such claims or rights as a result of the assumption of the TCM Factory Contracts, it shall immediately pay such proceeds to Party A. Any right, obligation, risk and liability under TCM Factory Contracts occurred after the Closing Date shall be owned, borne or assumed by the JVC pursuant to this Contract. Should Party A has received any advance payment or realized any rights a head of time prior to the Closing Date, Party A shall immediately pay the received amount to the JVC or transfer the realized rights to the JVC for free.
CHAPTER VIII
BOARD OF DIRECTORS
8.1. The Board of Directors shall consist of six (6) Directors with three (3) appointed by Party A and three (3) appointed by Party B. The term of office for the Directors (including the Chairman and the Vice-Chairman) shall be four (4) years. Any Director whose term has expired may continue to serve on the Board of Directors after obtaining approvals from both Parties. Each Director is entitled to cast one vote. No Director shall have any personal liability for any act performed in his capacity as Director of the JVC except for such acts that would constitute violations of the published laws of any jurisdiction to which the JVC or the relevant Director (as the case may be) is subject.
If a seat on the Board is vacated by the retirement, resignation, illness, disability or death of a Director or by removal of such Director by the Party which originally appointed him, the Party which originally appointed such Director
shall appoint a successor within thirty (30) days from the date of vacancy and notify the other Party in writing; otherwise, it shall be deemed to have waived its rights during the period of vacancy until a successor is appointed. Such successor shall be appointed to serve out the balance of the relevant term.
8.2. There is a Chairman and a Vice-Chairman in the Board of Directors. The Parties agree that the Chairman and the Vice-Chairman of the JVC shall be appointed by Party A and Party B in turn. For the initial term, the Chairman shall be appointed by Party B and the Vice-Chairman shall be appointed by Party A; for the second term, the Chairman shall be appointed by Party A and the Vice-Chairman shall be appointed by Party B; and so forth. The terms of office for the Chairman and the Vice-Chairman shall not exceed that for the Directors. The Chairman of the Board shall be the legal representative of the JVC.
8.3. The JVC shall convene its first Board meeting within seven (7) days after its incorporation to: (i) establish the operation and management organization of the JVC; (ii) approve the nominations of the General Manager, the Managing Deputy General Manage, the Deputy General Manage, the CFO and the Deputy CFO; and (iii) authorize the General Manager to head and build the management team and take charge of the JVCs daily operation. The establishment the organizational structure of the JVC, its manufacturing, operation, management, financial matters, accounting, audit, human resources management as well as the labour union, shall be implemented by the management team headed by the General Manager in accordance with the Articles of Association of the JVC and the Board resolutions.
8.4. The Board of Directors is the highest authority of the JVC, which discusses and determines the major matters of the JVC. Meetings of the Board shall be held at least twice each year at the registered address of the JVC. The Chairman of the Board shall set an agenda after consultation with the Vice-Chairman of the Board and be responsible for convening and presiding over such meetings. The Board of Directors shall deliver a notification to each Director within ten (10) days prior to the meeting of the board setting forth the agenda, date and location of the meeting.
8.5. Upon the written request of one-third (1/3) or more of Directors of the JVC specifying the matters to be discussed, the Chairman of the Board shall, after consultation with the Vice-Chairman, convene an interim meeting of the Board.
8.6. In case a Director is unable to attend a Board meeting, he/she may issue a proxy and entrust another person to attend the meeting on his/her behalf. The
representative so entrusted shall be deemed to represent such Director within the scope of the proxy and have the same rights and powers as the Director does. Should a Director fail to attend in person or by proxy, he/she will be deemed as having waived such right.
8.7. A quorum for a Board meeting (including regular meeting and interim meeting) shall require the presence, in person or by proxy, of at least four (4) Directors. The Board of Directors shall not adopt resolutions at a Board meeting where a quorum is not present. If a quorum shall fail to attend, the Chairman shall deliver a seven days notice to each Director to call another meeting.
8.8. Each Party shall procure that the Directors appointed by such Party attend, in person or by proxy, each of the duly convened Board meetings.
8.9. The Directors owe fiduciary duties and duties of care to the JVC and may not engage in any activities that compete with, or may jeopardize any interests of the JVC.
8.10. All of the major matters of the JVC shall be determined by the Board of Directors, including but not limited to:
(1) amendment of the Joint Venture Contract and/or the Articles of Association of the JVC;
(2) the merger of the JVC with any other economic organization, and the split-off of the JVC;
(3) termination or dissolution of the JVC;
(4) the increase or transfer of the JVCs registered capital;
(5) investment in any other company or enterprise by the JVC;
(6) establishment of branches or other business premises;
(7) signing of, amendment to, or termination of any contract between the JVC (as one party) and any Party hereof or the affiliates or joint venture company of such Party (as the other party), or any decision to waive the right to take legal actions against the counterparty for breach of contract;
(8) distribution of after-tax profits of the JVC to the Parties in any fiscal year;
(9) review and approval of the amounts of the reserve fund, the development fund, and the employee bonus and welfare fund (the Three Funds) that the JVC is required to set aside for each fiscal year under the Implementation Rules of Peoples Republic of Chinas Sino-foreign Joint Venture Enterprise Law and supervision of expenditures of these three funds; review and approval of the amounts of other funds (e.g. the housing provident fund) that the JVC is required to set aside under PRC Laws, and supervision of expenditures of such funds;
(10) review and approval of any sale or purchase of any fixed assets or real property with a value exceeding [**] by the JVC; review and approval of any commercial contract or product sales contract signed by the JVC in which the amount involved exceeds [**], or any purchase contract signed by the JVC in which the amount involved [**], except for any contract contained in any already adopted financial budget as set forth in item (11) below;
(11) examination and approval of the JVCs long-and-medium-term corporate strategies, marketing strategies, major infrastructure plans, research and development plans and production scale, financing plans and budgets proposed by the management;
(12) approval of major reports submitted by the General Manager (e.g. reports on production capacity, annual operational reports, funds, loans);
(13) review and approval of the annual tax returns, and the audited financial statements;
(14) approval of any guarantee, security, loan or borrowing provided by the JV;
(15) approval of the basic organizational structure of the JVC and the establishment of the management positions for key departments;
(16) examination and approval of internal policies and major rules and regulations of the JVC (including but not limited to the financial and accounting policies, annual labour plans of the JVC, salary standards and subsidies and allowance standards for employees of the JVC , approval of the labour insurance and social welfare standards for employees of the JVC);
(17) appointment and dismissal of the General Manager and/or the Managing Deputy General Manage, the Deputy General Manage, the CFO and the Deputy CFO;
(18) decision to engage external accountants, auditors and attorneys for the JVC;
(19) approval for opening bank accounts and appointment of the signatories;
(20) JVCs filing major lawsuits or arbitrations, and revolving any legal issues related to the JVC;
(21) any change in the existing arrangement that the Chairman, the Vice-Chairman, the General Manager, the Managing Deputy General Manage, the CFO and the Deputy CFO shall be recommended and appointed by Party A and Party B, and any revision of the current principle that the Parties shall appoint Chairman, the Vice-Chairman, the General Manager, the Managing Deputy General Manage, the CFO and the Deputy CFO in turn;
(22) any arrangement that would change the power and duty of the General Manager; and
(23) any matter that at least two (2) Directors request to examine by submitting written requests to the Board..
8.11. Resolutions involving the matters set forth in items (1)-(5) of Section 8.11 shall be adopted by the unanimous affirmative vote of all Directors present in person or by proxy at a duly convened board meeting. Resolutions involving the other matters set forth in Section 8.10 shall be adopted by the affirmative vote of at least 2/3 of the Directors or their proxies in attendance at a duly convened Board meeting, provided that such Directors must include at least one Director appointed by each Party. In case a deadlock occurs when a board resolution in respect of the matters listed in items (1)-(23) of Section 8.10 (the Relevant Matters) fails to receive the required minimum number of affirmative votes, the Parties shall conduct friendly consultation regarding the Relevant Matters, and reconvene a Board meeting to re-deliberate the Relevant Matters within fourteen (14) days. If no resolution regarding the Relevant Matters is adopted at the re-convened Board meeting within fourteen (14) days from the date on which the re-convened meeting is held, the Parties agree that senior executives of both Parties shall coordinate and settle the matters. If the senior executives of both Parties fail to settle the matters within
fourteen (14) days, the Parties shall engage a highly respected person in the traditional Chinese medicine industry to mediate the Relevant Matters.
8.12. The Board of Directors may adopt any resolution by signing the written resolution by all Directors without holding a Board meeting. Such written resolution should be kept with the minutes of the Board meetings for record and shall have the same effect as resolutions unanimously adopted at the Board meetings.
8.13. In general, Directors shall perform their duties without any remuneration. However, Directors are entitled to reimbursement for all out-of-pocket expenses incurred in attending meetings of the Board and may be entitled to remuneration and reimbursement in relation to special tasks assigned to them by the Board under a budget approved by the Board.
8.14. Functions and Duties of the Chairman
(1) The Chairman will perform the following functions and duties in his/her capacity as the legal representative of the JVC:
(i) to convene and presides over the Board meeting;
(ii) to check the implementation status of the Board resolutions and report such status to the Board of Directors;
(iii) subject to the Board resolutions and decisions, to provide support to major business activities of the JVC;
(iv) to sign important documents of the JVC and the relevant lawsuit and arbitration documents that should be signed by the Chairman;
(i) with approval of the Board of Directors, sign the issuance documents and important contracts for corporate stocks and bonds; and
(v) if the Chairman is unable to sign any documents that must be signed by the Chairman in a timely manner, in order not to affect the day-to-day operation of the JVC, to authorize the General Manager or another director of the JVC to sign such documents on his/her behalf.
(2) The Vice-Chairman shall assist the Chairman with his/her work and may perform the functions and duties of the Chairman if the Chairman is unable to perform his/her functions and duties due to temporary absence, illness or lack of capacity.
The Chairman, the Vice-Chairman and the Directors shall perform their functions and duties within the scope of authorization granted by the Board of Directors. Without obtaining prior written authorization and consent of the Board of Directors, the Chairman, the Vice-Chairman or the Directors may not act beyond their scope of authorization and execute any contract or agreement that imposes restrictions on the JVC.
Each Board meeting shall have detailed minutes with signatures of the Directors/representatives thereof as well as the minute takers. The Directors shall have the right to have remarks added to the minutes. The minutes shall be prepared in Chinese and kept on file by the JVC.
CHAPTER IX
MANAGEMENT ORGANIZATION
9.1. The JVC shall implement a system whereby the General Manager assumes responsibility under the leadership of the Board of Directors and shall have an operation and management organization, which is responsible for the day-to-day operation and management of the JVC. The operation and management organization shall have one General Manager, one Managing Deputy General Manage, one CFO, one Deputy CFO and several Deputy General Manages, all of whom shall have terms of four years and may serve consecutive terms upon approval by the Board.
9.2. The Parties agree that the General Manager, the Managing Deputy General Manage, the CFO and the Deputy CFO shall be recommended by the Parties in turn and appointed by the Board of Directors of the JVC. The Parties agree that, for the initial term, the General Manager (the existing director of the Guangzhou Baiyunshan Traditional Chinese Medicine Factory shall serve as the General Manager of the JVC for the initial term) and the Deputy CFO shall be recommended by Party A and appointed by the Board of Directors of the JVC, while the Managing Deputy General Manage and the CFO shall be recommended by Party B and appointed by the Board of Directors of the JVC; for the second term, the General Manager and the Deputy CFO shall be recommended by Party B and appointed by the Board of Directors of the JVC, while the Managing Deputy General Manage and the CFO shall be recommended by Party A and appointed by the Board of Directors of the JVC; and so forth.
9.3. The General Manager shall perform the following functions and duties:
(1) to organize and carry out resolutions of the Board of Directors, and report work to the Board of Directors;
(2) to take charge of the day-to-day operation, business and financial management of the JVC;
(3) to draft plans related to the operation and management of the enterprise and submit such plans to the Board of Directors for approval, including but not limited to the development plan, the annual production and operational plan and the profit distribution plan of the JVC;
(4) to organize and carry out the annual operational plan and the investment plan of the JVC;
(5) to draft plans regarding establishment of the internal management organizations as well as the management positions of the JVC;
(6) to draft the internal policies of the JVC and establish the management rules and policies of the JVC;
(7) appointment or dismissal of managers except for those who should be appointed or dismissed by the Board of Directors;
(8) to decide on matters relating to the employment, reward and punishment and dismissal of JVC employees;
(9) to deal with important external business matters on behalf of the JVC; and
(10) other functions and duties as authorized by the Board of Directors.
9.4. The General Manager shall perform his/her functions and duties within the scope granted by the Board of Directors, and shall not change any Board resolution. The General Manager shall submit a monthly operation and financial report to the Board of Directors within thirty (30) days following the close of month reported.
9.5. The Parties agree that the operation and management, business development, financial solutions and the implementations plans for each particular work of the JVC should strictly comply with the principles and development plans that the Parties set out in the Feasibility Study Report attached hereto as Appendix (F), including enterprise strategies, organizational structure, number of employees, financial budgets, salary scales, research and development plans, factory renovation, facility upgrades, asset management and operation, and marketing. The Feasibility Study Report is attached hereto as Appendix (F).
9.6. If the General Manager is unable to perform his/her functions and duties due to temporary absence, illness or lack of capacity, the functions and duties of the General Manager shall be assumed by a person designated by the General Manager. If there is a need to change the General Manager within his/her tenure in office due to above reasons, the Board of Directors shall hold a meeting to discuss and determine the matter according to the relevant provisions in Chapter 8.
9.7. The General Manager reports to the Board of Directors and is supervised by the Board of Directors. The General Manager and other management members may not engage in any activities that compete with, or may jeopardize any interests of the JVC.
9.8. In accordance with the needs and situations of the enterprise, the operation and management organization shall have several Deputy General Managers who report to the General Manager and the Managing Deputy General Manager, take change of the operational planning and management for each business unit, and instruct and supervise the work of the subordinated departments. The General Manager shall consult with the Managing Deputy General Manager and nominate the Deputy General Managers, and such nomination shall take effect upon approval from the Board of Directors.
9.9. The Board of Directors may hold a Board meeting at any time to adopt a resolution to dismiss any senior management member who has committed a corrupt act or gross dereliction of duty, including the General Manager, the Managing Deputy General Manage, the Deputy General Manage, the CFO and the Deputy CFO.
CHAPTER X
CERTIFICATES
, APPROVALS AND TRADEMARKS
10.1. Both Parties agree that Party A will make in-kind contribution to the JVC, as part of its capital contribution, of the intangible assets of TCM Factory which it legally owns (including the Two Certifications, the Product Certificate or Product Approval and each of the TCM Factorys applications for trademarks and patents as detailed in Appendix I hereto).
10.2. Party A undertakes that it will file applications with the relevant PRC governmental authorities to transfer the Two Certifications, the Product Certificate or Product Approval and the patents of TCM Factory to the JVC within one month upon the Closing Date and shall complete the aforesaid
procedures within 12 months so that the JVC becomes the lawful owner of the above certificates, license or approval and patents. Party B may extend the period for Party A to perform such obligation in light of the actual situations.
10.3. Party A undertakes that it shall execute Bai Yun Shan( 白云山 ) Trademark License Agreement (Appendix G hereto) in conjunction with the execution of this Contract, under which Party A authorizes the JVC the right to use the trademark of Bai Yun Shan and Party A will be responsible for the filing of the Bai Yun Shan Trademark License Agreement with the State Trademark Office. Party B shall be responsible for all the taxes and fees incurred from the transfer of the Two Certifications, the Product Certificate or Product Approval and the patents of TCM Factory to the JVC.
10.4. Party B undertakes that it will procure that Hutchison Whampoa Enterprises Limited (HWEL) enters into the Hutchison Whampoa Trademark License Agreement (Appendix H hereto) in conjunction with the execution of this Contract, whereby after it has obtained the approval of the trademarks registration, HWEL will license the JVC to use the trademarks of Hutchison Whampoa(和记黄埔) ,Hutchison(和记) and Hehuang(和黄) , and the HWL logo, and be responsible for the filing of the Hutchison Whampoa Trademark License Agreement with the State Trademark Office. Given that HWEL is currently applying for the registration of the trademarks of Hutchison Whampoa and Hutchison and the HWL logo for use in the traditional Chinese medicine sector and healthcare products sector, Hutchison Whampoa Trademark License Agreement will become effective automatically upon the approval of the trademark registration. Party B undertakes it shall procure that HWEL grants a royalty-free license to the JVC to use the trademarks of Hutchison Whampoa(和记黄埔) ,Hutchison(和记) and Hehuang(和黄), and the HWL logo within or outside PRC (subject to the final approval by the relevant authority). Party B undertakes it will complete all procedures for above matters within 18 months from the Closing Date. Party A may extend the period for Party B to perform such obligation in light of the actual situations.
10.5. The JVC, being the true legal owner of the Two Certifications, the Product Certificate or Product Approval and the patents of TCM Factory, shall be entitled to use the Two Certifications, the Product Certificate or Product Approval and the patents of TCM Factory. Party A undertakes that it will cease the use of the aforesaid Two Certifications, the Product Certificate or Product Approval and the patents of TCM Factory from the Date of Establishment of the JVC. The details of the Two Certifications, the Product Certificate or Product Approval and the patents of TCM Factory referred herein are set out in Appendix I List of Two Certifications, the
Product Certificate or Product Approval and the Patents of TCM Factory.
10.6. Both Parties agree to grant the royalty-free license the JVC to use the trademarks of Bai Yun Shan( 白云山 ), Hutchison Whampoa(和记黄埔), and BYS and the HWL logo. Subject to both Parties consent, JVCs subsidiaries (in which the JVC holds not less than 50% equity interest) may use such trademarks and logo by reference to the terms and conditions provided to the JVC, under which case, the subsidiaries shall separately enter into trademark license agreement with the trademark holders. Both Party A and Party B have initially determined that their respective Affiliates and Associated Companies shall not be granted the license to use the trademarks Bai Yun Shan( 白云山 ), Hutchison Whampoa a(和记黄埔), Hutchison(和记) and Hehuang(和黄) and BYS and the HWL logo on the products of Radix, Compound Danshen Tablets, Dashen Stomatitis Cure, Anti-inflammatory Gall-Bladder-Excreting Tablets, Andrographis Tablets (the Five Products) . The Parties may consult with each other and separately decide the adjustment, reduction or increase with respect to the use of the trademarks or logos on the Five Products in accordance with the needs of market development.
CHAPTER XI
SITE
11.1. As part of its contribution to the JVCs registered capital or the difference between the total investment amount and the registered capital, Party A shall provide to the JVC the transferrable and collateralizable land use right over the Site for the Joint Venture Term. Details in relation to the Sites are set out in Appendix C hereto. The JVC shall have full discretion to demolish or reconstruct any building set forth in Appendix C at its own cost as long as it is in compliance with PRC Laws.
11.2. Party A hereby represents and undertakes that it has the land use right over the Site and the ownership of the factory buildings and equipment thereon (Party A is in the application process for the land use certificates for the part of the Site and real estate ownership certificates for the factory buildings). Part A shall have full right and obligation to transfer such land use right and ownership to the JVC during the Joint Venture Term and be liable for the corresponding responsibilities. Party A warrants that a) save as those disclosed to Party B, the Sites are free of any security, lien or claim; b)the land use
period are subject to the record shown on the Land-Use Certificate, and c) the JVC will obtain the transferrable and collateralizable land use right pursuant to the this Contract. Party A shall bear all the taxes and fees arising from the transfer of the land use right and ownership to the JVC and indemnify and reimburse Party B against any losses or liabilities incurred by the JVC arising relating to the taxes and fees.
11.3. Party A has entered into the Grant State-owned Land Use Right Contract related to the land use right over the Site described in Appendix C hereto with Guangzhou City Land Resources Bureau, pursuant to which, Party A has obtained the state-owned land use right and the land use certificate for the Site. In addition, after it has obtained the land use right certificate, Party A has provided to Party B and the JVC a copy of the Grant State-owned Land Use Right Contract and the relevant documents issued by the Guangzhou City Land Resources Bureau evidencing the full payment of the land use right premium and related taxes and fees. Party A warrants that these documents are true, complete and valid.
11.4. Party A has entered into the Transfer Contract with the JVC, pursuant to which, the JVC may apply to Guangzhou City Land Resources Bureau for the issuance of the legal and valid land-use right certificates, real estate ownership certificates and boundary map in relation to the Sites described in Appendix C hereto, evidencing that the JVC has the following land use right over the Sites stated in Appendix C hereto:
(i) the land use right is obtained through transfer with consideration;
(ii) the land use periods are subject to the term shown on the land use certificates;
(iii) the land use purpose meets the needs of the JVC to operate the traditional Chinese medicine business as described in Section 3.2 herein;
(iv) the land use right is transferrable or collateralizable subject to PRC Laws; and
(v) during the term of land use right, the JVC has the ownership of the houses and buildings (including construction-in-progress) listed in Appendix C hereto.
11.5. Party A is currently in the process of applying for the grant of the land-use right for the Site and transfer of the houses and buildings thereon as described in this Chapter11 and Appendix C hereto. Party A undertakes it will ensure the JVC has the right to use the aforesaid land and houses/buildings from the Closing Date, and Party A shall have the obligation and responsibility to complete the transfer of the land use right and ownership to the JVC and obtain all the required governmental approvals within 12 months from the Closing Date so that the JVC becomes the legal owner of such land use right for the Site and houses/buildings thereon. Party B may extend the period for Party A to perform such obligation in light of the actual situations.
CHAPTER XII
PURCHASE OF EQUIPMENT AND MATERIAL
12.1. In its purchase or lease of the required production equipment, raw materials, accessories and and services, the JVC shall give priority to purchasing or leasing them in China unless there is a gap between the price, quality, reliability, support service, maintenance and delivery date of the goods and services available in China and those of imported goods and services, or the goods and services available in China simply cannot fulfil the operational requirements of the JVC. Based on the aforesaid principle, Subject to clause Section 8.10 (10) herein, the General Manager has the right to make decision with respect to the purchase of equipment, raw materials, accessories and services outside China.
CHAPTER XIII
CONTRACTING WITH THIRD PARTIES
13.1. Except as otherwise provided herein or in the Articles of Association, the General Manager may conclude any contract or enter into any undertaking with a third party on behalf of or under the name of the JVC for matters in connection with the day-to-day business and operation and management of the JVC, provided that the General Manager shall submit the material contracts and undertakings of the JVC to the Board of Directors for review and approval and such contracts and undertakings shall be executed by the Chairman of the Board or its authorized person.
CHAPTER XIV
LABOUR MANAGEMENT
14.1. Policies and procedures for the hiring, employment, dismissal, remuneration, labour insurance, welfare and benefits, penalty and rewards etc. shall be formulated by the General Manager in accordance with the Labour Law of the Peoples Republic of China and other relevant provisions and submitted to the Board of Directors for approval. The implementation of these policies thereafter shall be responsible by the management team under the guidance of the General Manager.
14.2. Pursuant to Chapter 13 of the Regulations for the Implementation of the Law of the Peoples Republic of China on Chinese-foreign Equity Joint Ventures, employees of the JVC shall have the right to establish a labour union to represent their interests and with the labour union funds allocated by the JVC pursuant to the PRC Law, to develop labour union activities and other activities as permitted for the PRC joint venture enterprises.
14.3. The General Manager, within the powers delegated by the Board of Directors, shall have the discretion to determine, in accordance with the PRC labor management laws and Board resolutions, the conditions of employment of the staff and workers of the JVC, internal rules, procedures and standards for hiring, firing and disciplining employees and arrangements for work and leave, etc.
14.4. Both Parties agree that, for the purposes of ensuring JVCs stable operation in the early stage and avoiding massive personnel changes, the JVC shall enter into new employment contracts with the existing employees of the TCM Factory. For the retired employees of the TCM Factory, the JVC shall make a one-off payment of [**] to Party A to be used toward compensation and benefits for the retired employees of the TCM Factory. Save as the payment of aforesaid [**], the JVC shall take no financial or legal liability or obligation of any kind for the retired employees of the TCM Factory. Party A shall be responsible for paying to the retired employees any additional compensations of any kind resulted from the change of the state and local laws, regulations or policies or any other reason, and in no event shall Party B or the JVC be responsible in connection therewith. Subject to the approval of the Board of Directors, the JVC may hire its employees directly from open recruitment. The JVC shall have the discretion to recruit the employees required from the society in accordance with the development plan.
14.5. The engagement of the General Manager, Managing Deputy General Manager, Chief Financial Officer and Deputy Chief Financial Officer of the JVC and their wages and benefits, social insurance, welfare, standards for business travel expenses, etc., shall be discussed and decided by the Board in accordance with the prevailing market conditions.
14.6. To the extent permitted by PRC Laws, both Parties agree to procure that the Board of Directors of the JVC formulates and implements an incentive plan and scheme to provide incentives to key management members for their long service with the JVC, including but not limited to performance-based share options, bonus, level of remuneration, pay structure, incentive compensation, etc. This scheme shall be formulated in accordance with the prevailing market conditions and the JVCs actual condition and must be in the best interests of the JVC.
CHAPTER XV
TAXATION
15.1. The JVC shall pay various taxes in accordance with PRC Laws and shall enjoy all preferential policies and treatments granted by the Central Government and the local government.
15.2. The employees of the JVC shall pay their respective income tax in accordance with the Individual Income Tax Law of the Peoples Republic of China.
CHAPTER XVI
FINANCIAL AFFAIRS AND ACCOUNTING
16.1. The JVC shall establish an accounting organization, provide itself with accounting personnel and formulate its accounting system in accordance with the Accounting System of the Peoples Republic of China for Chinese-foreign Equity Joint Ventures and in the light of its own actual circumstances and execute the accounting system upon the discussion and approval of the Board of Directors. The accounting system of the JVC must be filed for record with the Guangzhou Finance Bureau and Guangzhou Taxation Bureau.
16.2. The JVC shall prepare monthly, quarterly and annual financial statements, including a profit and loss statement, balance sheet, cash flow statement and other forms.
The Board of Directors shall engage a PRC-qualified and registered public accounting firm as the independent auditor to examine and verify the annual financial reports of the JVC in accordance with PRC Laws and by reference to internationally used accounting methods. In addition, the JVC shall permit a qualified international or PRC auditor appointed by each Investing Party to examine its records on each behalf, provided that, the Board of Directors will be given prior notice of such examination and the expenses incurred therefrom will be borne by the Investing Party which requested the examination.
The annual financial reports and examination reports shall be delivered to each Director at least seven (7) days before the same are submitted to the Board of Directors for approval.
The Annual financial reports and annual audit reports which have been approved by the Board of Directors shall be distributed to both Party A and Party B and to the relevant governmental authorities for filing according to PRC Laws.
16.3. All expenditure documents of the JVC shall be valid only if processed in accordance with the financial accounting system and signed by the General Manager or a person authorized thereby. The JVC shall use the invoices issued by the tax authority as evidence of receipt and payment. The invoices issued for the oversea (including Hong Kong and Macao) purchase of merchandise such as machinery, equipment, parts and components (where custom declarations are required) will be deemed valid only if supported by declaration forms with the PRC ports of entry or custom declaration forms with the PRC customs.
16.4. The JVC shall adopt the internationally used accrual basis of accounting and the debit and credit method of keeping accounts in its accounting. All vouchers, books, receipts, statements and other accounting documents shall be printed in Chinese. The JVC shall use Renminbi as its standard bookkeeping currency.
16.5. The fiscal year of the JVC shall run from January 1 to December 31 of the Gregorian calendar year. The first fiscal year of the JVC shall run from the Closing Date to December 31 of the same year.
16.6. Each year, the JVC shall set aside out of its net profits certain amount for the Three Funds, the total of which shall not exceed ten percent (10%) of the net profits for that year. The specific amounts of the three Funds set aside and their percentages shall be decided by the Board of Directors without violating
relevant PRC Laws. In the event of the liquidation of the JVC, any unused portion of the reserve fund and expansion fund shall be treated as part of the assets of the JVC.
16.7. The net profits of the JVC after deductions of the Three Funds shall be distributed to the Parties in proportion to their respective contribution to the JVC. The JVCs targeted profit distribution for each year shall be ranged from thirty to forty percent (30% - 40%) of its net profits. However, the amount of dividend to be distributed shall be determined by the Board of Directors based on the profit level, future cash flows, utilization of cash and the business development of the JVC.
CHAPTER XVII
FOREIGN EXCHANGE CONTROL
17.1. All matters in relation to foreign exchange control of the JVC shall be dealt in accordance with the Regulations on Foreign Exchange Control of the Peoples Republic of China.
17.2. The JVC shall open a foreign currency account with a bank authorized by PRC Laws to accept foreign exchange business. The foreign currency revenue of the JVC shall be deposited in such account.
17.3. After paying relevant income tax and other expenses , the Parties shall assist its foreign and Hong Kong expatriate staff and workers of the JVC in applying for permission to remit abroad their remaining income in accordance with the relevant PRC Laws.
17.4. In accordance with the relevant PRC Laws, Party B may freely convert to foreign currencies the dividends derived from the JVC and remit outside China, and Party A shall assist the JVC in applying for remittance of such profits.
17.5. The JVC shall be responsible for balancing its foreign exchange revenues and expenditures and generating profits.
CHAPTER XVIII
EFFECTIVE DATE, TERM AND TERMINATION
18.1. This Contract shall come into effect on the date of approval noted on the approval certificate issued by the relevant governmental authority.
18.2. The term of this Contract shall be fifty (50) years, commencing from the Date of Establishment of the JVC. Upon expiry of the Joint Venture Term, the Parties may consult to each other and decide to apply for extension of the Joint Venture Term. If the Investing Parties unanimously agree to extend the Joint Venture Term, and a resolution to that effect is adopted at a Board meeting, a written application shall be submitted to the Approval Authority six (6) months prior to expiry of the Joint Venture Term. The term shall be extended only upon approval of such application. The procedures for amendment of registration shall be carried out with the registration authority.
18.3. If both Investing Parties consider it to be in their best interests to terminate the JVC, they may terminate the JVC early.
In case of early termination , a resolution to that effect shall be adopted by unanimous approval of all Directors in attendance at a Board meeting and such early termination shall be reported to the Approval Authority for approval.
18.4. This Contract may also be terminated prior to expiry if:
(1) either Party becomes bankrupt, shutdown or is liquidated; or a major portion of its property connected with its joint venture business is acquired, arrested, appropriated or requisitioned by any third party; or such portion of its property has been taken over control by an appointed receiver. In each case above, the Party affected may terminate the Contract by giving written notice to the other Party. Such termination shall take effect thirty (30) days after the date next following that on which the written notice is received;
(2) the JVC is unable to operate ordinarily because all or substantial part of the JVCs assets have long been requisitioned by the government authorities;
(3) any competent governmental authority requires any Party to revise any provisions of this Contract or impose any conditions or restrictions on the implementation of this Contract, causing material adverse consequences to the JVC or any Parties benefits;
(4) the JVC is unable to continue its business operations due to its inability to make up the accumulated losses or the occurrence of irreparable serious damages to its assets; and
(5) the JVC is rendered unable to continue its normal operation by an event or its consequence of Force Majeure as set forth in Section 22.1 herein which continues in existence for over one hundred and eighty (180) days.
18.5. If either Party issues a notice for the purpose of terminating the Contract with respect to the circumstances set forth in Section 18.4 above, the Parties shall negotiate and endeavor to eliminate the cause for termination within two (2) months from the date of the issuance of such notice. If, by the end of such twenty (20) days period, both Parties fail to agree on the solution to such issues, the Board of Directors shall submit an application to the Approval Authority for early termination. In addition, the provisions set out in Section 18.6 below shall be applied.
18.6. the Parties fail to reach a negotiated solution after either Party has delivered a notice of early termination pursuant to Section 18.5, the JVC shall continue its operation only under the following circumstances if a Party (the Purchaser) notifies the other Party (the Seller) of its intention to acquire the equity of the JVC held by the Seller (the Acquisition Notice), and the acquisition of such interests shall be proceeded on the following terms and conditions:
(1) both Parties shall negotiate a purchase price to their satisfaction. However, if Party A and Party B fail to reach a mutually acceptable purchase price within thirty (30) days from the date of receipt of the Acquisition Notice, the purchase price shall be determined pursuant to Section (2) below;
(2) Party A and Party B may each, within sixty (60) days from the date of the Acquisition Notice, appoint a PRC-qualified public accounting firm or an appraiser in writing to jointly conduct a valuation of the JVC and notify the Purchaser of such appointment. The Party which fails to appoint an accounting firm or an appraiser shall be deemed as it has waived its right of the appointment. The joint valuation shall be completed with thirty (30) days from the date of appointment and shall be made based on the assumption that the JVC continues in business as a going concern. The purchase price shall be equal to the product of a) value of the JVC as determined based on the joint valuation multiplied by b)the percentage of registered capital held by the Seller at that time;
(3) unless otherwise agreed in writing by both Parties, ten percent (10%) of the purchase price determined in accordance with (1) and (2) above of this Section shall be paid within seven (7) days following the execution of the contract, and another forty percent (40%) shall be paid within three (3) months and the balance shall be paid within six (6) months;
(4) if Party B is the Seller, the purchase price shall be paid in accordance with the relevant PRC Laws; and
(5) if a Party does not accept the purchase price determined pursuant to the above provisions, or it has accepted such purchase price but the Seller does not receive the full payment of the same in accordance with the above provisions, the JVC shall be liquidated pursuant to Section19 herein.
18.7. Prior to the liquidation of the JVC, both Investing Parties shall continue the performance of their obligations and exercise of their rights, and ensure the ordinary operation of the JVC.
CHAPTER XIX
LIQUIDATION AND DISPOSAL OF THE ASSETS OF THE JOINT VENTURE COMPANY
19.1. In the event of the early termination of the Contract or upon expiry of the Joint Venture Term, the Board of Directors shall appoint a liquidation committee which has the authority to represent the JVC in all legal matters and shall value and liquidate the JVCs assets in accordance with the applicable PRC Laws and the principles set out herein.
19.2. The liquidation committee shall be made up of six (6) members, of which three (3) members shall be appointed by Party A and three (3) members shall be appointed by Party B. Members of the liquidation committee may, but need not, be the Directors of the JVC. Either Party may also appoint professional advisors, such as accountants and lawyers qualified either in China or abroad, to assist the liquidation committee.
19.3. The liquidation committee shall conduct a thorough examination of the JVCs assets and liabilities, on the basis of which it shall develop a liquidation plan which, if approved by the Board of Directors, shall be executed under the liquidation committees supervision.
19.4. In developing and executing the liquidation plan, the liquidation committee shall hall use every effort to sell the JVCs assets and business at the highest possible price in foreign exchange. Consideration shall be given to sale of the JVCs assets or business by public auction or by tender open to domestic and foreign bidders with a view towards obtaining prices at international market rates. If necessary, Renminbi shall be converted to foreign exchange in accordance with the relevant PRC Laws. Any expenses related to the conversion of Renminbi to foreign exchange shall be borne by Party B.
19.5. The liquidation expenses, including remuneration to members and advisors of the liquidation committee, shall be paid out of the JVCs assets in priority to the claims of other creditors.
19.6. After the liquidation or division of the JVCs assets and the settlement of all of its outstanding debts, the balance of the JVCs assets shall be paid to the Parties in proportion to their respective contribution to the registered capital of the JVC. The Party which has made its contribution to the JVC in foreign currency shall have the priority to be paid in foreign currency.
19.7. On completion of all liquidation procedures, the liquidation committee shall submit a final report approved by the Board to the Approval Authority, and hand in the JVCs Business License to the original registration authority and complete all other formalities for nullifying the JVCs registration. Party B shall have the right to obtain copies of all of the JVCs accounting books and other documents but the originals thereto shall be left in the care of Party A.
19.8. The JVC shall change the above name immediately to a name not including the word Hutchison Whampoa(和记黄埔) and Bai Yun Shan(白云山) or any name resembling in any manner the name Hutchison Whampoa(和记黄埔) and Bai Yun Shan(白云山) upon the expiry or termination of the JVC,
19.9. In any event as prescribed in Section 19.8, both Parties undertake that it will never use the names, trademarks owned by the other Party or any resembling word to the trademarks and names of the other Party to continue or take over the business of the JVC. The JVC and the Investing Parties agree to take actions necessary to fulfil this undertaking.
CHAPTER XX
INSURANCE
20.1. All items of insurance of the JVC shall be taken out by the JVC from the insurance company which it considers most suitable as permitted by Chinese law. The risks insured, insured values, coverage periods, etc., shall be discussed and decided upon at meetings of the JVCs Board of Directors in accordance with the policies of the insurance company.
CHAPTER XXI
AMENDMENT OF THE CONTRACT
21.1. This Contract (including its appendices) may be amended only by written agreement executed by the Investing Parties. Such amendments shall come into effect upon the approval of the Approval Authority.
CHAPTER XXII
FORCE MAJEURE
22.1. If during the Joint Venture Term the performance of this Contract is directly affected by, or this Contract cannot be performed on the agreed conditions due to, an earthquake, typhoon, flood, fire, war or other event of force majeure which cannot be foreseen and the occurrence and consequences of which cannot be prevented or avoided, the Party affected by such event of force majeure shall promptly notify the other Party in writing of the details of such event and shall, within fifteen (15) days, provide detailed information on the event and a valid certificate attesting to the reason why the Contract cannot be performed or can only be partially performed or why the term for its performance needs to be extended.
22.2. Such certificate shall be issued by the notarial organization of the place where the event of force majeure occurred. The Investing Parties shall consult with each other and decide whether this Contract shall be terminated or whether part of the obligation to perform this Contract shall be released or whether the term for performance of this Contract shall be extended, according to the extent of the impact of the event of force majeure on the performance of this Contract.
CHAPTER XXIII
SETTLEMENT OF DISPUTES AND GOVERNING LAW
23.1. Any dispute arising from this Contract shall be settled through friendly consultations. If a dispute cannot be settled within sixty (60) days after the commencement of consultations, then a Party to the dispute may submit it to the South China Branch of the China International Economic and Trade Arbitration Commission in Shenzhen for arbitration in accordance with its arbitration procedures. Such arbitration shall be final and binding on both Parties.
23.2. During the period of arbitration of a dispute, the Investing Parties shall continue to perform their obligations hereunder, except for those obligations involved in the matter under dispute, and to exercise their rights hereunder.
23.3. The execution, validity, interpretation and performance of this Contract and the settlement of disputes related to this Contract shall all be protected and governed by PRC Laws.
23.4. The JVC and the Parties shall apply for any tax, investment and other benefits or preferences more favourable than the terms of this contract that become available or publicly known after date hereof.
CHAPTER XXIV
CONFIDENTIALITY
24.1. Both Parties hereby agree that they shall not disclose to any third party any part of this Contract (including appendices), or any other agreements that either Party may be negotiating, or details of confidential negotiations in reaching such agreements, or any business or secrets disclosed by either Party, except as required by law or any stock exchange, or for purpose of preforming one Partys obligations under the abovementioned Contract or agreements. When such requirement to disclose has arisen, the disclosing Party shall obtain the other Partys written consent prior to the disclosure, which consent shall not unreasonable delayed.
24.2. The Parties shall cause their Directors and other Working Personnel, and those of their Subsidiaries or Affiliated Companies, also to comply with the confidentiality obligation set forth in Section 24.1 above.
24.3. The obligation under Section 24.1 above shall survive the termination of this Contract and the termination and dissolution or liquidation of the JVC howsoever caused.
CHAPTER XXV
BREACH OF CONTRACT
25.1. If a Party fails to perform any of its obligations under this Contract (including its Appendices) or breaches any terms hereunder or if a Partys representation or warranty under this Contract is untrue or materially inaccurate, such Party shall be deemed to have breached this Contract. The breaching Party shall have thirty (30) days from receipt of notice from the other Parties specifying a breach to cure such breach (if curable). If a curable breach is not cured within thirty (30) days, the breaching Party shall indemnify the other party against any losses arising from such breach. If a breach is not curable, the breaching Party shall immediately indemnify the other party against any losses arising from such breach.
25.2. If any Party materially breaches the terms herein, causing material adverse effect to the other Party or the JVC, the other Party shall have a right to terminate this Contract within nighty (90) days upon the discovery of the breach and liquidate the JVC, provided that a prior written notice of no less than sixty (60) days shall be given to the Party in breach. If the breaching Party has remediated the breach before the expiry of the termination deadline prescribed in the written notice, such termination notice shall be deemed as void.
CHAPTER XXVI
GENERAL PROVISIONS
26.1. The invalidity of any provision of this Contract shall not affect the validity of any other provision of this Contract.
26.2. This Contract is written in Chinese.
26.3. This Contract and its Appendices attached hereto constitute the entire agreement between the Parties with respect to the subject matter of this Contract and supersede all prior discussions, negotiations and agreements between them.
26.4. A Party unable to exercise or delaying its exercise of any rights or power under this Contract and its Appendices shall not be deemed as a waiver to these rights and powers. Any single or partial waiver made to the rights or powers shall not prejudice the contracting Parties to exercise the rights or powers of the same kind in the future.
26.5. Any notice or written communication provided for in this Contract by one Party to another, including but not limited to any and all offers, writings, or notices to be given hereunder, shall be made in Chinese or English and promptly sent or delivered by one Party to another Party by facsimile, and shall be subsequently confirmed by registered air-mail.
26.6. With respect to the communications and notices given pursuant to the provisions herein, the date of receipt of a notice or communication hereunder shall be deemed to be twelve (12) days after its postmark in the case of an airmail letter and two (2) working days after dispatch in the case of a facsimile. All the notices and communications shall be sent to the appropriate address or facsimile numbers as shown on the top of the first page, until the same is changed by notice given in writing to the other Party.
CHAPTER XXVII
APPENDICES
27.1. The following Appendices constitute a part of this Contract. In the event of a discrepancy between the interpretation of the provisions of the Appendices attached hereto and the provisions of this Contract, this Contract shall prevail. The Appendices are as follows:
Appendix A: List of Party As Assets
Appendix B: TCM Factory Contracts
Appendix C: Map for the Sites, Plant and Buildings
Appendix D: Products List of the JVC
Appendix E: Contribution Schedule
Appendix F: Feasibility Study Report
Appendix G: Bai Yun Shan Trademark License Agreement
Appendix H: Hutchison Whampoa: Trademark License Agreement
Appendix I: List of Two Certifications, the Product Certificate or Product Approval and the Trademarks and Patents the TCM Factory
Appendix J: List of Medicine for External Use
IN WITNESS WHEREOF, this Contract is signed as of the date stated at the top of the first page by the following authorized representatives of the Parties.
(Signatory page follows. No text on this page)
Party A: Guangzhou Baiyunshan Pharmaceutical Holding Co., Ltd.
Signature: [Company seal] |
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Name: XIA Zemin |
/s/ XIA Zemin |
Title: President |
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Nationality: Chinese |
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Party B: HUTCHISON CHINESE MEDICINE (GUANGZHOU) INVESTMENT LIMITED [ 和黄药业(广州)投资有限公司 ]
Signature: |
/s/ TO Chi Keung |
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Name: TO Chi Keung |
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Title: Director |
For and on behalf of HUTCHISON CHINESE MEDICINE |
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Nationality: British |
(GUANGZHOU) INVESTMENT LIMITED [ 和黄药业(广 |
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州)投资有限公司 ] |
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/s/ TO Chi Keung |
THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
English Translation
SHANGHAI NO. 1 CHINESE MEDICINE CO. LTD.
EQUITY JOINT VENTURE CONTRACT
January 6, 2001
CONTENTS
CHAPTER 1 DEFINITIONS |
4 |
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CHAPTER 2 ESTABLISHMENT OF THE JOINT VENTURE COMPANY |
7 |
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CHAPTER 3 PURPOSE, SCOPE OF BUSINESS AND PRODUCTION SCALE OF THE JOINT VENTURE COMPANY |
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CHAPTER 4 TOTAL AMOUNT OF INVESTMENT AND REGISTERED CAPITAL |
8 |
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CHAPTER 5 ASSIGNMENT OF INVESTMENT |
12 |
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CHAPTER 6 SPECIAL OBLIGATIONS OF THE PARTIES |
13 |
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CHAPTER 7 REPRESENTATION, WARRANTIES AND UNDERTAKINGS |
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CHAPTER 8 BOARD OF DIRECTORS |
18 |
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CHAPTER 9 MANAGEMENT ORGANIZATION |
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CHAPTER 10 CERTIFICATE, APPROVAL AND TRADEMARK |
24 |
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CHAPTER 11 SITE |
25 |
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CHAPTER 12 PURCHASE OF EQUIPMENT AND MATERIAL |
26 |
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CHAPTER 13 CONTRACTING WITH THIRD PARTIES |
26 |
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CHAPTER 14 LABOUR MANAGEMENT |
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CHAPTER 15 TAXES |
27 |
CHAPTER 16 FINANCIAL AFFAIRS AND ACCOUNTING |
28 |
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CHAPTER 17 FOREIGN EXCHANGE |
29 |
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CHAPTER 18 EFFECTIVE DATE, TERM AND TERMINATION |
29 |
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CHAPTER 19 LIQUIDATION AND DISPOSAL OF THE ASSETS OF THE JOINT VENTURE COMPANY |
32 |
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CHAPTER 20 INSURANCE |
33 |
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CHAPTER 21 AMENDMENT OF THE CONTRACT |
33 |
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CHAPTER 22 FORCE MAJEURE |
33 |
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CHAPTER 23 SETTLEMENT OF DISPUTES AND GOVERNING LAW |
34 |
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CHAPTER 24 CONFIDENTIALITY |
34 |
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CHAPTER 25 BREACH OF CONTRACT |
35 |
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CHAPTER 26 GENERAL PROVISIONS |
35 |
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CHAPTER 27 APPENDICES |
36 |
THIS EQUITY JOINT VENTURE CONTRACT (the Contract) is jointly signed in Shanghai Municipality, the Peoples Republic of China (the PRC or China) on this sixth day of January 2001 by and between:
Party A: Shanghai Traditional Chinese Medicine Co., Ltd., a corporate legal person established and existing pursuant to the laws of the PRC and registered with the Shanghai Municipal Administration for Industry and Commerce, China, with its legal address at 239 Hankou Road, Shanghai Municipality, China; Fax number: (86-21) 6350 2061.
The authorized legal representative for this Contract:
Name: Mr. Xu Qinfa
Position: Chairman
Nationality: Chinese
Party B: Hutchison Chinese Medicine (Shanghai) Investment Limited, a limited liability company established and existing pursuant to the laws of British Virgin Islands, with its registered address at P.O. Box 957, Offshore Incorporation Centre, Road Town, Tortola, British Virgin Islands and its correspondence address at Room 2018, 22nd Floor, Hutchison House, 10 Harcourt Road, Central, Hong Kong; Fax number: (852)28100772
The authorized legal representative for this Contract:
Name: Mr. Simon To Chi Keung
Position: Board Director
Nationality: British
PRELIMINARY STATEMENT
In accordance with the Law of the Peoples Republic of China on Sino-foreign Equity Joint Venture Enterprises, the implementation regulations issued thereunder and other applicable laws and regulations, the aforesaid Parties, adhering to the principle of equality and mutual benefit and through friendly consultations, agree to form a joint venture company on the following terms and conditions in Shanghai Municipality, China.
CHAPTER 1
DEFINITIONS
For the purposes of this Contract, the following terms shall have the meanings set out below:
1.1. Affiliate shall mean any company that directly, or indirectly controls or is controlled by, or under common control with either of the Parties. Control shall mean having, directly or indirectly, more than fifty percent (50%) of the equity interest or controlling power or management power.
1.2. Associated Company shall mean a company in which any of the Parties holds, directly or indirectly, greater than twenty percent (20%) but less than fifty percent (50%) of the equity interest.
1.3. Parties hereto or Parties shall mean Party A and Party B. Party hereto or Party shall mean Party A or Party B, as the context may require.
1.4. Investing Party or Investing Parties shall mean Party A, Party B or both Party A and Party B, as the context may require.
1.5. JVC shall mean Shanghai No.1 Chinese Medicine Co., Ltd. established by the Investing Parties in Shanghai Municipal, China pursuant to this Contract.
1.6. Contract Products or JVC Products shall mean the products transferred by Party A to the JVC pursuant to this Contract.
1.7. Varieties shall have the basic meaning ascribed to it under the Regulations on the Protection of Varieties of Traditional Chinese Medicines ( 中藥品種保護條例 ) and also include part or all of the followings (if applicable): national standards (which shall have the same meaning with national drug standards as defined in The Drug Administration Law of the Peoples Republic of China) of a certain pharmaceutical variety, prescription, form of dosage, relevant patents, copyright and other intellectual property rights, manufacturing practices or processes, as well as other related technical data and information. Variety can be any one of the following types:
(1) patented varieties: means varieties of traditional Chinese medicine for each of which a certificate of patent has been granted;
(2) protected varieties: means varieties of traditional Chinese medicine for each of which a certificate of variety of traditional Chinese medicine under protection has been granted, including Class I protected varieties, Class II protected varieties and any other classes of protected varieties;
(3) varieties of traditional Chinese medicine which have achieved China national drug standards or standards of provinces, municipalities or autonomous cities;
(4) new drugs: varieties of traditional Chinese medicine for each of which a new drug certificate has been granted;
(5) varieties of traditional Chinese medicine for which the China drug approval numbers have been granted;
(6) any other varieties of traditional Chinese medicine which satisfy the standard of the China Pharmacopoeia or Chinese pharmaceutical standards; and
(7) other varieties of traditional Chinese medicine recognized by the JVC and approved by the drug regulatory authority of the PRC.
1.8. Investment shall mean the actual capital contributions paid by the Parties to the JVC and the Parties ownership percentage in the JVC in proportion to their capital contributions.
1.9. Articles of Association shall mean the Articles of Association of the JVC.
1.10. Board of Directors or Board shall mean the Board of Directors of the JVC consisted of the Directors nominated by the Investing Parties hereto.
1.11. Effective Date shall mean the approval date specified in the approval certificate issued by the relevant PRC governmental authority upon the approval of this Contract and the Appendices hereto.
1.12. Date of Establishment shall mean the date of issuance of the JVCs business license.
1.13. Examination and Approval Authority shall mean the Ministry of Foreign Trade and Economic Cooperation or the examination and approval authority entrusted thereby.
1.14. Joint Venture Term shall mean the term set forth in Section 18.2 hereunder or that term as may be extended or shortened pursuant to Section 18.2 or Section 18.4 hereunder.
1.15. Party As Assets shall mean the buildings, structures, production equipment and other assets located on the Sites and at any other locations, which will be contributed to the JVC pursuant to this Contract. A description of Party As Assets to be contributed to the JVC, together with the appraised value thereof, is included in Appendix A hereto.
1.16. Party As Contracts shall mean the outstanding contracts concluded by Party A (and to be transferred to the JVC) which the JVC must continue to perform. The basic terms and conditions of such contracts are set forth in Appendix B hereto.
1.17. Renminbi or RMB shall mean the legal currency in China.
1.18. US Dollars or US$ shall mean legal currency of the United States of America.
1.19. SAFE shall mean the State Administration of Foreign Exchange of PRC or its Shanghai branch.
1.20. Sites shall mean a piece of land and area in Shanghai Municipality, the land use right over which will be acquired by the JVC under this Contract for the duration of the Joint Venture Term. The site map showing the location and boundaries of the plots of land and relevant documents are attached hereto as Appendix C.
1.21. Two Certificates shall mean the pharmaceutical manufacturing permit ( 藥品 生產許可 證 ) and the GMP certificate for drugs ( 藥品生產合格證 ).
1.22. Product Certificate or Product Approval shall mean the state new drug certificate or product approval.
1.23. Working personnel shall mean all workers and other staff (except for the Board Directors and senior personnel) of the JVC, including personnel seconded to the JVC by either Party.
CHAPTER 2
ESTABLISHMENT OF THE JOINT VENTURE COMPANY
2.1. In accordance with the Law of the PRC on Sino-foreign Equity Joint Venture Enterprises, the implementing regulations issued thereunder and other applicable laws and regulations of the PRC, the Parties, adhering to the principle of equality and mutual benefit and through friendly consultations, agree to establish this JVC in Shanghai Municipality, China. The JVC may establish offices in Mainland China, Hong Kong, Macao, and other countries as needed, by discussion and decision of the Board of Directors and subject to approval by the relevant governmental authorities.
2.2. The JVC shall apply for registration with the Shanghai Municipal Administration for Industry and Commerce, China. All activities of the JVC in China shall comply with the laws, decrees and regulations of China and be protected and governed by the laws of the PRC.
2.3. The JVC shall be a limited liability company. The liability of the Investing Parties shall be limited to the amounts of their respective capital contribution.
2.4. The profits, risks and losses shall be shared by the Investing Parties in proportion to their respective ownership percentage.
2.5. The JVC shall continue to perform Party As Contracts signed by or assigned to Party A, the basic terms and conditions of which are listed in Appendix B hereto. Party A guarantees that the relevant documents and information provided by it in Appendix B hereto are complete, true and valid.
2.6. The JVC shall be an independent economic entity and entitled to all preferential treatment granted to the Sino-foreign joint venture enterprises by the PRC government and the Shanghai Municipal Peoples Government. The JVC shall have
full autonomy in its business operations and decide its business policies in the best interests of the JVC.
2.7. The Chinese name of the JVC shall be 上海和黃藥業有限公司 . The English name of the JVC shall be SHANGHAI NO. 1 CHINESE MEDICINE CO. LTD.
2.8. The legal address of the JVC shall be : 2098 Zhennan Road, Shanghai Municipality, China ( 中國上海市真南路 2098 號 ).
CHAPTER 3
PURPOSE, SCOPE OF BUSINESS AND PRODUCTION SCALE OF THE JOINT VENTURE COMPANY
3.1. The purpose of the JVC shall be, through the joint venture formed by the Parties, to enhance economic cooperation and technology exchanges, development and promote modernization of traditional Chinese medicines, apply advanced technology, facilities and equipment, and absorb management experience from abroad, so as to bring satisfactory economic benefits to the Parties.
3.2. The business scope of the JVC shall be to produce, research and develop traditional Chinese medicine in the form of injections, tablets, powder, liquids and capsules, and sell these self-manufactured products.
3.3. The Parties agree that the JVC shall, from the Varieties with Production Approval provided by Party A, select the profitable Varieties that meet market demand for production and sale. Product Varieties provided by Party A to the JVC are detailed in the Product Catalogue of the JVC in Appendix D hereto. The JVC shall accelerate its research and development of new Varieties of traditional Chinese medicine and commence production as soon as possible according to market conditions.
CHAPTER 4
TOTAL AMOUNT OF INVESTMENT AND REGISTERED CAPITAL
4.1. The total amount of investment of the JVC shall be ([**]).
4.2. The total amount of the JVCs registered capital shall be ([**]).
4.3. The capital contributed by each Party and the ownership percentage shall be as follows:
(1) Party As contribution to the JVCs registered capital shall be ([**]), representing fifty percent (50%) of the registered capital.
(2) Party Bs contribution to the JVCs registered capital shall be in US Dollar or Hong Kong Dollar in an amount equivalent to ([**]), representing fifty percent (50%) of the registered capital.
4.4. Each Party shall contribute or raise capital as follows:
(1) Each Party shall contribute capital in the following manner pursuant to Sections 4.5 to 4.7 hereunder:
Party A: Party As contribution to the JVC shall be Party As Assets valued at ([**]). Party As Assets are listed in Appendix A hereto.
Party B: Party Bs contribution to the JVC shall be cash in US Dollar or Hong Kong Dollar in an mount equivalent to ([**]).
If either Party fails to make its contribution pursuant to the above provision, the other Party may elect to terminate and liquidate the JVC by giving notice to the non-contributing Party, or subject to the PRC laws, to adjust the ownership percentage to a percentage equal to their actual capital contributions.
(2) The balance between the total amount of investment and the registered capital shall be provided or raised by each Party as follows:
a) in proportion to their ownership percentages in the JVC as specified in Section 4.3 herein, Party A shall provide funds to the JVC in the form of certain assets (as described in Appendix A hereto- Party As Assets) and cash (including shareholder loans), and Party B shall provide funds to the JVC in cash (including shareholder loans); and b) the JVC may raise funds through loans or other financial instruments from third parties. Each Party shall raise funds or provide guarantee for the JVC in proportion to their ownership percentages as and when needed. If the JVC cannot raise funds through loans or other financial instruments as described in b) above, each Party shall under any circumstance whatsoever provide funds to the JVC pursuant to this provision.
If either Party fails to provide funds pursuant to the above, the other Party may elect to terminate and liquidate the JVC by giving notice to the non-contributing Party, or to purchase the non-contributing Partys equity interest in the JVC at an appraised value pursuant to the laws of the PRC.
The Parties agree that, if further register capital is required for the operation and development of the JVC, each Party shall make additional capital contribution to the registered capital in proportion to their existing ownership percentage in the JVC. After the resolution for capital increase is unanimously passed by the Board of Directors, if either Party is unwilling to make additional contribution, the other Party may elect to contribute the non-contribution Partys portion of such additional capital contribution. In such case, Party A and Party Bs ownership percentage in the JVC shall be adjusted accordingly (the ownership percentage of the contribution Party shall be increased and that of the non-contributing Party shall be decreased), and the rights and obligations of each Party in the JVC (including without limitation, the number of Directors each Party is entitled to appoint) shall also be adjusted accordingly.
4.5. Subject to the satisfaction of each of the conditions precedent under Section 4.6 herein or waiver by mutual consent of the Parties of certain conditions precedent, the Parties shall pay make their respective contribution to the JVC pursuant to the payment schedule as prescribed in Section 4.7 herein.
4.6. The Parties obligations to make contribution to the registered capital of the JVC are subject to the satisfaction of each of the following conditions precedent:
(1) relevant governmental authorities have formally approved the initiation and feasibility study report of the project contemplated under this Contract;
(2) the JVC has obtained the certificate of approval and other approvals of the Contract and Articles of Association from the Examination and Approval Authority, and obtained the temporary Business License for Corporate Legal Person in the PRC (the Business License);
(3) the JVC has obtained Taxation Registration Certificate for Foreign Investment Enterprise in the PRC;
(4) the JVC has obtained Foreign Exchange Registration Certificate for Foreign Investment Enterprise and Finance Registration Certificate for Foreign Investment Enterprise;
(5) a qualified appraisal organization has delivered an asset valuation report on the Party As Assets as listed in Appendix A, and the State-owned Assets Administration Office has approved the asset valuation report;
(6) the JVC has legally obtained the certificates of land use right and the real estate ownership certificates pursuant to the provisions of Chapter 11 herein;
(7) the JVC has legally obtained the Two Certificates and Product Certificate or Product Approval required for the production of the sixty-eight products in the name of the JVC; and
(8) the JVC and Party A have executed the license agreement in relation to the trademark of Shanghai Pharma ( 上藥 ) in the form attached hereto as Appendix H, under which, Party A grants the JVC the exclusive right to use the Shanghai Pharma trademark before Party A has formally and legally transferred the Shanghai Pharma trademark to the JVC, and such license agreement has been filed with the State Trademark Office.
If any of the above conditions precedent is not fulfilled within three (3) months from the date of the issuance of the JVCs Business License, or not waived by both Parties in writing within thirty (30) days after the lapse of the aforesaid 3-month period, neither party is obligated to make its contribution, and either Party has the right to terminate the Contract.
4.7. The Parties agree to make their respective contribution to the registered capital according to the following schedule:
(1) the Parties shall pay their respective contribution within three (3) months from the date of the issuance of the JVCs Business License. The contribution schedule is detailed in Appendix E;
(2) if any of the conditions precedent listed in Section 4.6 is not fully satisfied within the period specified in (1) above, or not waived by both Parties in writing, and neither Party exercises its right to terminate the Contract, within three (3) months from the date of the issuance of the Business License, Party A shall pay all of its contribution to the JVC on a one-time basis, and Party B shall pay [**)] of its contribution to the JVC. If any of the conditions precedent is not fully fulfilled within one and a half years, or not waived by both Parties in writing, the JVC shall be liquidated.
4.8. Upon obtaining the Business License, the JVC shall convene the first Board meeting pursuant to Section 8.4 herein and open a Renminbi account and a foreign currency account following the first Board meeting. The Parties shall then pay their respective contribution to the JVC pursuant to the proportion of contribution specified in Section 4.3 above, the form of contribution specified in Section 4.4 and the contribution schedule as stated in Section 4.7.
4.9. All payment of the contribution shall be calculated at the exchange rate equal to the average rate of the foreign exchange selling and buying rates published by the Peoples Bank of China on the date of payment.
4.10. Promptly after the Investing Parties have made their contributions, the JVC shall engage an accounting firm registered in China to verify the contributions and issue a capital verification report. Pursuant to this capital verification report, the JVC shall issue investment share certificates, which shall specify the name and the Date of Establishment of the JVC, the name of the Investing Party, the amount of
contributions and the date on which such contributions were made, and the date of issuance of the investment share certificate.
CHAPTER 5
ASSIGNMENT OF INVESTMENT
5.1. Neither Party shall assign, sell or otherwise dispose of all or part of its Investment to a third party without prior written consent of the other Party.
5.2. If a Party (the Disposing Party) wishes to assign, sell or otherwise dispose of all or part of its Investment, it shall notify the other Party of the terms and conditions of the proposed assignment in writing and the other Party shall have the right of first refusal.
5.3. If the other Party has not exercised it right of first refusal within three (3) months, the Disposing Party may assign, sell or otherwise dispose of all or part of its Investment to a third party at a price and on terms not more favourable than those provided to the other Party. The Disposing Party shall provide to the other Party a copy of the written agreement signed with the purchaser/assignee.
5.4. Notwithstanding the foregoing, the Parties agree that either Party may assign all or part of its Investment to their Affiliates. The Parties hereby acknowledge and agree on such assignment and waive their right of first refusal, and will procure the Board of Directors to approve such assignment.
5.5. The assignment of its Investment by any Party shall be subject to the following conditions:
(1) the assignee has signed the relevant written documents in the forms as reasonably requested by the other Party, whereby the assignee agrees to be bound by this Contract and enjoy interests and rights under the Contract as if it were an the original Party hereto; and
(2) the business operation or performance of contracts of the JVC must not be interrupted by such sale, assignment or other disposal of the Investment interests.
5.6. The sale, assignment or other disposal of the Investment shall be submitted to the competent Examination and Approval Authority for approval in accordance with the laws. Upon the receipt of the approval from the Examination and Approval Authority, the JVC shall file the registration of changes with the Shanghai Municipal Administration for Industry and Commerce.
The above provision is not applicable to the circumstances as specified in Section 18.4 herein.
5.7. Without the consent from the other Party, neither Party shall pledge, mortgage or otherwise encumber all or any part of its equity interest in the JVC.
CHAPTER 6
SPECIAL OBLIGATIONS OF THE PARTIES
6.1. Party A shall:
(1) [**]
(2) [**]
(3) [**]
(4) [**]
(5) [**]
(6) [**]
(7) [**]
(8) [**]
(9) [**]
(10) [**]
6.2. Party B shall:
(1) [**]
(2) [**]
(3) [**]
(4) [**]
(5) [**]
(6) [**]
CHAPTER 7
REPRESENTATION, WARRANTIES AND UNDERTAKINGS
7.1. For the purpose of this Contract, Party A makes the following unconditional and irrevocable representations and warranties to Party B:
(1) Party A is an enterprise established and existing pursuant to the laws of the PRC and is an independent corporate legal person;
(2) Party A has the power and legal capacity to execute and perform this Contract and all other documents related to the Contract where Party A is a party;
(3) Party A has taken all measures and obtained all authorizations to execute this Contract and all other related documents where Party A is a party;
(4) Party A has obtained all approvals, consents, authorizations and permissions from relevant governmental authorities to execute this Contract, Articles of Association and Appendices; and
(5) Party A is the lawful owner of and has full and valid title to the contribution made by Party A to the JVC, free and clear of any securities, mortgages, pledges, lien and/or other encumbrance/debt and/or third party rights or claims.
7.2. For the purpose of this Contract, Party B makes the following unconditional and irrevocable representations and warranties to Party A:
(1) Party B is a limited liability company established and existing pursuant to the laws of its place of registration and is an independent corporate legal person;
(2) Party B has the power and legal capacity to execute and perform this Contract and all other documents related to the Contract where Party B is a party;
(3) Party B has taken all measures and obtained all authorizations to execute this Contract and all other related documents where Party B is a party;
(4) Party B has obtained all approvals, consents, authorizations and permissions to execute this Contract, Articles of Association and Appendices; and
(5) Party B is the lawful owner of and has full and valid title to the contribution made by Party B to the JVC, free and clear of any securities, mortgages, pledges, lien and/or other encumbrance/debt and/or third party rights or claims..
7.3. Upon negotiations, Party A or Party B agrees to make the following unconditional and irrevocable representations, warranties and undertakings:
(1) the assets and liabilities as of the date hereof which have been confirmed in writing by Party B will be transferred to the JVC by Party A. Any asset or liability that is not confirmed by Party B shall be owned or assumed by Party A, and Party A warrants it will be responsible for any issues arising therefrom, and guarantees the JVC will not be involved in any economic or legal disputes or suffer any losses arising therefrom;
(2) the balance sheet confirmed by the Parties will be audited by a qualified accounting firm in China appointed by the Parties. The audited financial statements shall be used as the basis for the general ledger the JVC;
(3) considering that a) Party A is in continual operation as a going concern; b) the balance sheet in Appendix A hereto solely reflects the transaction price of the Party As Assets as agreed by both Parties based on appraisal, and c) there have been changes in the balance sheet from the appraisal date to the Date of Establishment, the Parties agree to appoint a qualified accounting firm in China to audit the financial statements of Party As Assets for a period ended on the Date of Establishment (the Audited Financial Statements), and adjust the financial statements in Appendix A hereto on the basis of the Audited Financial Statements. The JVC will prepare its accounts on the basis of the Audited Financial Statements;
(4) Party A represents and warrants that all information related to the assets and liabilities disclosed to Party B is complete, true and valid. Party A shall indemnify the JVC against any damages and losses incurred or suffered by the JVC arising from any untrue statements by Party A;
(5) starting from the Date of Establishment, Party A shall assist the JVC in counting, stocktaking and confirming the assets, and deliver to the JVC all assets, documents and materials that the JVC shall be entitled to, and the JVC shall then confirm the receipts of the above in writing to Party A;
(6) Party A represents and warrants that a) all land, power and environmental facilities as part of Party As contribution into the JVC are in compliance with regulatory requirements and in good working conditions; and b) Party A has not received any order or other instructions from any governmental authority, requiring Party A to change land use, or add, expand or remodel any facilities to fulfil regulatory requirements;
(7) in connection with the account receivables confirmed by both Parties as listed in the balance sheet in Appendix A hereto, Party A shall execute contracts, agreements or confirmation letters with relevant enterprises or individual debtors (the Debtors), whereby the Debtors shall confirm the amount owed by them to the JVC and undertake to pay the confirmed amount to the JVC within three months from the Date of Establishment. Any amount that has not been confirmed or paid by Debtors shall be deducted from the balance sheet and Party B may reduce its capital contribution into the JVC by an amount equals to such unpaid or unconfirmed amount;
(8) the liquid liabilities confirmed by both Parties as listed in balance sheet in Appendix A hereto are the maximum liabilities that the JVC agrees to assume. Party A shall handle or settle any additional or unrecorded liabilities and guarantee the JVC will not be held responsible for such liabilities or suffer any damages;
(9) Party A shall obtain the approval of the transfer of the state-owned assets to the JVC from the competent State-owned Assets Administration Office;
(10) Party A agrees to assist the JVC in obtaining loans from banks on terms and conditions no less favourable than those offered to Party A. JVC shall grant security interests over its assets as the banks may require. The Parties shall provide guarantee in favour of the banks in proportion to their ownership percentage in the JVC if additional guarantee is required. Before it obtains such loans from the banks, the JVC will confirm to Party A in writing that it would assume a loan of [**] listed on Party As balance sheet. This confirmation letter will become invalid on the date when the loans are deposited in JVCs account;
(11) Party A shall be responsible for dealing with the legal and economic relations and assume any liabilities in connection with its investment projects or tertiary industry projects that are not taken over by the JVC, and ensure, under no circumstance will the JVC be liable for any consequences in connection with the projects.
(12) in connection with Party As in-kind contribution of inventory to the JVC, Party A warrants that a) the inventory (including raw materials, finished drug products and packaging materials) is relevant to the [**] product Varieties of the JVC; b) the raw materials and auxiliary ingredients comply with the quality standard and requirements; and c) and the semi-finished products and finished products of the traditional Chinese medicine have not expired. Party B may engage a pharmaceutical research institute to test the inventory as it deems necessary, and pharmaceutical research institutes decision shall be final and binding. Any inventory which does not comply with the aforesaid requirements will not be accepted as part of the contribution to the JVC, and Party B may reduce its contribution to the JVC by an amount equals to the value of such unqualified inventory.
(13) after the establishment of the JVC, Party A shall procure that the employees of the No.1 Chinese Traditional Medicine Factory who would be retained by the JVC enter into the employment contracts with the JVC. Party A shall be responsible for the employees who are not retained by the JVC (the Redundant Employees). Except for the redundancy payment provided by Party B and paid by the JVC as stipulated in Section 14.4 herein, the JVC shall not have any legal or economic responsibilities for the Redundant Employees. The Parties agree that upon the establishment of the JVC, the number of employees required shall be [**];
(14) Party A guarantees it shall be responsible for all taxes (sales tax, value-added tax and income tax, etc.) and employees taxes (including, without limitation, personal income tax), social welfare funds and other expenses incurred prior to Date of Establishment of the JVC, and ensures that the JVC has nothing to do with these taxes and expenses. Party A undertakes that from the Date of Establishment of the JVC, it shall assist the JVC in maintaining its normal operation and keeping all supply chains (including but not limited supply chains related to raw materials, auxiliary ingredients, packaging materials, semi-finished products) running smoothly;
(15) Party A warrants that it is the lawful owner of the Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark, and no third party has raised or will raise any claim or objection in respect of such ownership. Party A has full right to transfer the Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark to the JVC. Party A undertakes that starting from the Date of Establishment of the JVC, it will stop production and cease all use of the Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark, provided that Party A has a grace period of six months to use the Shanghai Pharma trademark so that it can continue to sell any inventory of packaging materials with Shanghai Pharma trademark until such materials have been consumed. The grace period shall not exceed six months from the date hereof. The inventory of packaging materials are listed in Appendix J hereto and the grace period shall not apply to any product that is not included in the list.
(16) the Parties undertake that they will assist the JVC in protecting the Shanghai Pharma trademark and preventing any infringement, counterfeiting or other diminution in value (the Infringement), and they will immediately notify the senior management of the JVC if they detect any Infringement, so the JVC can take necessary actions to stop such Infringement and seek remedies against infringers ;
(17) Party A ensures that the JVC has autonomy to recruit any employee to fill a position at any time without any constraint, and Party A, its Associated Company or its Affiliate will not object or hinder the JVC from recruiting
any employee who has worked for Shanghai Pharmaceuticals Holding Co., Ltd., its Affiliate or Associated Company; and
(18) the Parties hereby agree that Party A shall be responsible for all debts and liabilities (except for the accounts payable listed in Appendix A hereto that will be assumed by the JVC as agreed by Party B) related to Party As Contracts (listed in Appendix B hereto) occurred prior to the date on which Party As Contracts (Appendix B hereto) are transferred to the JVC (the Transfer Date), and under no circumstance, will the JVC be responsible for such debts or liabilities. Party A shall indemnity, reimburse and hold the JVC harmless from any losses (including proceedings and legal fees) incurred by the JVC arising out of or resulting from any third party claim or demand brought after the Transfer Date against the JVC with respect to Party As above debts or liabilities. Party A shall be entitled to any benefits arising under Party As Contracts relating to claims or rights incurred or brought against any third party prior to the Transfer Date. The JVC agrees to assist Party A in exercising or realizing such right or claim as and when needed. If the JVC receives any proceeds relating to such claims or rights as a result of the assumption of Party As Contracts, it shall immediately pay such proceeds to Party A. JVC shall assume any right, obligation, risk and liability under Party As Contracts occurred after the Transfer Date pursuant to this Contract. Should Party A has received any advance payment or realized any rights ahead of time prior to the Transfer Date, Party A shall immediately pay the received amount to the JVC or transfer the realized rights to the JVC for free. Party A shall be responsible for all liabilities and obligations under the contracts that are not transferred to the JVC, and the JVC has nothing to do with such contracts.
CHAPTER 8
BOARD OF DIRECTORS
8.1. The Board of Directors shall consist of six (6) Directors with three (3) appointed by Party A and three (3) appointed by Party B. No Director shall have any personal liability for any act performed in his capacity as Director of the JVC except for such acts that would constitute violations of the published laws of any jurisdiction to which the JVC or the relevant Director (as the case may be) is subject.
8.2. If a seat on the Board is vacated by the retirement, resignation, illness, disability or death of a Director or by removal of such Director by the Party which originally appointed him, the Party which originally appointed such Director shall appoint a successor within thirty (30) days from the date of vacancy and notify the other Party in writing; otherwise, it shall be deemed to have waived its rights during the period of vacancy until a successor is appointed. Such successor shall be appointed to serve out the balance of the relevant term.
8.3. There is a Chairman and a Vice-Chairman in the Board of Directors. The Chairman shall be appointed by Party A and the Vice-Chairman shall be appointed by Party B.
The term of office for the Directors shall be four (4) years, which may be renewed with the consent of both Parties. The Chairman of the Board shall be the legal representative of the JVC. Each Director shall be entitled to cast only one vote.
8.4. The JVC shall convene its first Board meeting within seven (7) days after its establishment to set up the operation and management organizations of the JVC and to appoint a General Manager to oversee the daily operations of the JVC. The establishment of the organizational structure of the JVC, operation, management, finance, accounting, auditing, human resources management and labour union shall be handled in accordance with the Articles of Association.
8.5. The Board of Directors is the highest authority of the JVC, which discusse and determines the major matters of the JVC. Meetings of the Board shall be held at least twice each year at the registered address of the JVC or such other address in China or abroad as is designated by the Board. The Chairman shall set an agenda after consultation with the Vice-Chairman and be responsible for convening and presiding over the Board meetings. The Board shall notify all Directors in writing ten (10) days prior to the Board meeting, which shall specify the agenda, time and venue of the meeting.
8.6. Upon the written request of one-third (1/3) or more of the Directors of the JVC specifying the matters to be discussed, the Chairman shall, after consultation with the Vice-Chairman, convene an interim meeting of the Board.
8.7. In case a Director is unable to attend a Board meeting, he/she may issue a proxy and entrust another person to attend the meeting on his/her behalf. The representative so entrusted shall have the same rights and powers as the Director does. Should a Director fail to attend or to entrust another to attend, he/she will be deemed as having waived such right.
8.8. A quorum for a Board meeting (including regular meeting and interim meeting) shall require the presence, in person or by proxy, of at least four (4) Directors. The Board of Directors shall not adopt any resolution at a Board meeting where a quorum is not present. If a quorum shall fail to attend, the Chairman shall convene another meeting with seven (7) days prior notice to each Director.
8.9. Each Party shall procure that the Directors appointed by it attend each duly convened meeting of the Board in person or by proxy.
8.10. The Directors owe fiduciary duties and duties of care to the JVC and may not engage in any activities that compete with, or may jeopardize any interests of the JVC.
8.11. All of the major matters of the JVC shall be determined by the Board of Directors, including but not limited to:
(1) amendment of the Articles of Association of the JVC;
(2) the merger of the JVC with any other economic organization, and the split-off of the JVC;
(3) termination or dissolution of the JVC ;
(4) the increase or transfer of the JVCs registered capital;
(5) investment in any other company or enterprise by the JVC;
(6) establishment of branches or other business premises;
(7) execution of, amendment to, or termination of any contract between the JVC (as one party) and any Party hereto or its Affiliates or Associated Companies (as the other party), or any decision to waive the right to take legal actions against the counterparty for breach of contract;
(8) distribution of after-tax profits of the JVC to the Parties in any fiscal year;
(9) review and approval of the amounts of the reserve fund, the development fund, and the employee bonus and welfare fund (the Three Funds) that the JVC is required to set aside for each fiscal year under the Implementation Rules of Peoples Republic of Chinas Sino-foreign Joint Venture Enterprise Law and supervision of expenditures of the Three Funds; review and approval of the amounts of other funds (e.g. the housing provident fund) that the JVC is required to set aside under other laws and regulations of the PRC, and supervision over expenditures of such funds;
(10) review and approval of any sale or purchase of any fixed assets or real property with a value exceeding [**] by the JVC (except for any sale or purchase made under item (11) below);
(11) examination and approval of the JVCs long-and-medium-term production strategies, marketing plan and scope, infrastructure plans, research and development plans and production scale, financing plans, budgets, annual tax returns and audited financial statements.
(12) approval of major reports submitted by the General Manager (e.g. reports on production capacity, annual operation, funds, loans);
(13) review and approval of any business contracts in which the amount involved exceeds [**] (except for those entered into under item 11 above)
(14) approval of any guarantee, security, loan or borrowing provided by the JVC;
(15) approval of the basic organizational structure of the JVC and the setting up positions for management;
(16) examination and approval of internal policies and major rules the JVC (including but not limited to the financial and accounting policies, salary
standards, subsidies and allowance standards for employees of the JVC, the labour insurance and social welfare standards for employees of the JVC; and trainings provided to the Working personnel);
(17) appointment and dismissal of the General Manager;
(18) engagement of external accountants, auditors and attorneys for the JVC;
(19) approval for opening bank accounts and appointment of the signatories thereof;
(20) JVCs filing major lawsuits or arbitrations, and revolving any legal issues related to the JVC;
(21) any change in the existing arrangement that the Chairman, the Vice-Chairman, the General Manager shall be recommended by Party A and Party B; and
(22) any arrangement that would change the power and duty granted to the General Manager; and
(23) any matter that at least two (2) Directors request to examine by submitting written request.
8.12. Resolutions involving the matters set forth in items (1)-(5) of Section 8.11 shall be adopted by the unanimous affirmative vote of all Directors present in person or by proxy at a duly convened Board meeting. Resolutions involving the other matters set forth in Section 8.11 shall be adopted by the affirmative vote of at least 2/3 of the Directors or their proxies in attendance at a duly convened Board meeting, provided that such Directors must include at least one Director appointed by each Party. In case a deadlock occurs when a board resolution in respect of the matters listed in items (1)-(23) of Section8.11 (the Relevant Matters) fails to receive the required minimum number of affirmative votes, the Parties shall conduct friendly consultation regarding the Relevant Matters, and reconvene a Board meeting to re-deliberate the Relevant Matters within fourteen (14) days. If no resolution regarding the Relevant Matters is adopted at the reconvened Board meeting, the Parties agree that senior executives of both Parties shall negotiate and resolve the Relevant matters. If the senior executives of both Parties fail to resolve the Relevant Matters within fourteen (14) days, either Party (the Selling Party) may require the other Party to purchase its equity interest in the JVC in whole at a proposed price (the Selling Price); if the other Party refuses to purchase the Selling Partys equity interest in the JVC at the Selling Price, the other Party must sell all of its equity interest in the JVC to the Selling Party at the Selling Price.
8.13. The Board of Directors may adopt a resolution by signing the written resolution by all Directors without holding a Board meeting. Such written resolution should be
kept with the minutes of the Board meetings for record and shall have the same effect as resolutions unanimously adopted at a Board meeting.
8.14. In general, Directors shall perform their duties without any remuneration. However, Directors are entitled to reimbursement for all out-of-pocket expenses incurred in attending meetings of the Board and may be entitled to remuneration and reimbursement for special tasks assigned to them by the Board under a budget approved by the Board.
8.15. Authority of office of the Chairman:
(1) As the legal representative of the JVC, the Chairman shall exercise his/her powers and perform his/her duties as following :
(i) to apply to governmental authorities for the establishment of the JVC or other related matters;
(ii) to convene and chair Board meetings;
(iii) to examine the implementation of the resolutions and report to the Board of Directors;
(iv) subject to the Board resolutions and decisions, to support important business activities of the JVC;
(v) to sign material documents of the JVC and the relevant lawsuit and arbitration documents that should be signed by the Chairman; and
(vi) subject to the Boards approval, to sign documents and material contracts in relation to the issuance of the companys shares and bonds.
(2) The Vice-Chairman shall assist the Chairman with his/her work and exercise the powers or perform the duties of the Chairman when the Chairman is unable to exercise his powers due to absence, illness or disability.
The Chairman, Vice-Chairman and Directors shall exercise their powers or perform their duties within the scope of authority granted by the Board. Without prior written authorization of the Board, the Chairman, Vice-Chairman and Directors shall not sign any contract or agreement that may impose obligations o restrictions on the JVC.
8.16. Detailed minutes shall be taken for every Board meeting and signed by the Directors or their proxies and the board minutes recorder. The Directors have the right to add remarks to the board minutes. The minutes shall be written in Chinese and kept on file by the JVC.
CHAPTER 9
MANAGEMENT ORGANIZATION
9.1. The JVC shall implement a system under which the General Manager assumes responsibility under the leadership of the Board of Directors, and shall establish an
operation and management organization to oversea the day-to-day operation and management of the JVC. The operation and management organization shall have one General Manager who shall have a term of four (4) years and may serve consecutive terms upon approval by the Board. The Parties agree that the General Manager shall be nominated by Party B.
9.2. The General Manager has the following authorities and responsibilities:
(1) to organize and implement resolutions of the Board and report to the Board of Directors;
(2) to be fully responsible for the day-to-day administration, operation and financial management of the JVC;
(3) to devise development plans for the JVC, annual production and operation plans, and profit allocation proposal;
(4) to organize the implementation of the annual operation plan and investment proposals for the JVC;
(5) to propose the internal management organization ;
(6) to draft the management rules and policies for the JVC;
(7) to set up rules and regulations for the JVC;
(8) to employ or dismiss management members, except for those who should be employed or dismissed by the Board of Directors;
(9) to decide on matters relating to employment, reward, punishment and dismiss of employees of the JVC;
(10) to deal with important external business matters on behalf of the JVC; and
(11) to perform other duties granted by the Board.
9.3. When performing his/her duties, the General Manager shall not change the resolutions of the Board and exceed the scope of authority granted to him/her. The General Manager shall submit a monthly operation report and a monthly financial report to the Board of Directors within thirty (30) days following the close of month reported.
9.4. The Parties agree that the JVCs operation and management, business development, financial proposals and implementation plans for various projects shall strictly adhere to the principles and development plans devised by the Parties set forth in the feasibility study report in Appendix F hereto, including structural organization, number of employees, financial budget, salary levels, research and development plan, renovation of manufacturing plants, facility upgrades, marketing and sales. The feasibility study report is attached hereto as Appendix F.
9.5. When the General Manager is unable to exercise his authorities or perform his duties due to temporary absence, illness or disability, the person designated by the General Manager shall perform the duties and exercise the authorities of the General Manager. The Board shall convene a Board meeting to decide the replacement of the General Manager when a replacement is required.
9.6. The General Manager is accountable to the Board. The General Manager and other management member shall not engage in any activities that may compete with or be detrimental to the interests of the JVC, and they shall not concurrently assume any position in other organizations.
9.7. The operation management organization may have certain department managers who are accountable to the General Manager, oversee the work of each department, implement tasks assigned by the General Manager . The department manager (head) of each department shall be appointed by the General Manager.
9.8. The Board may adopt resolutions to dismiss and replace the General Manager or other senior managers who has committed a corrupt act or gross neglect of duty.
CHAPTER 10
CERTIFICATE, APPROVAL AND TRADEMARK
10.1. The Parties agree that Party A will make an in-kind contribution to the JVC, as part of its capital contribution, of the intangible assets valued at [**] it lawfully owns (including Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark).
10.2. Party A undertakes that a) within one month from the date of signing this Contract and relevant documents, it will file applications to relevant PRC governmental authorities and handle the formalities to transfer the Two Certificates and Product Certificate or Product Approval to the JVC so that the JVC becomes the legal Two Certificates and Product Certificate or Product Approval, and sign a licence agreement with the JVC to grant the JVC the exclusive right to use the Shanghai Pharma( 上药 ) trademark, and handle the filing of the license agreement with the State Trademark Office; and b) within one year from the Date of Establishment of the JVC, it will file an application with the State Trademark Office to transfer the Shanghai Pharma trademark to the JVC and sign a trademark transfer agreement with the JVC in the form attached hereto as Appendix G so that the JVC becomes the lawful owner of such trademark. Party A shall bear all taxes end expenses incurred in connection with the transfer of the Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark to the JVC.
10.3. As the true and lawful owner of the Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark, the JVC has full right to use the Two Certificates, Product Certificate or Product Approval and Shanghai
Pharma trademark. Party A undertakes that it will cease the use of the Two Certificates, Product Certificate or Product Approval and Shanghai Pharma trademark from the Date of Establishment of the JVC. Both parties agree that, in consideration of the actual situations of Party A, Party A is given a grace period of six months to use the Shanghai Pharma trademark so that it can continue to sell any inventory of packaging materials with Shanghai Pharma trademark until the materials have been consumed. The grace period shall not exceed six months starting from the date hereof. Upon the lapse of the six-month grace period, Party A shall unconditionally cease the use of the Shanghai Pharma trademark. Shanghai Pharma trademark as mentioned in this Section shall include the trademark, characters used in the trademark, logo, label, name, image and their combinations as detailed in Appendix G hereto the Trademark Transfer Agreement. The Two Certificates and Product Certificate or Product Approval as mentioned in this Contract are detailed in Appendix I- Lists of Two Certificates and Product Certificate or Product Approval.
CHAPTER 11
SITE
11.1. As part of its registered capital contribution, Party A shall provide to the JVC the transferrable and collateralizable land use right over the Site for the Joint Venture Term. Site details are set forth in Appendix C hereto. The JVC shall have the right to demolish or modify any building listed in Appendix C at its sole discretion and expense.
11.2. Party A hereby represents and warrants that presently it has the land use right over the Site and owns the factory buildings and other facilities on the Site. Party A has the right and obligation to transfer land use right and ownership to the JVC within the Joint Venture Term. Party A warrants that there is no claim, lien or debt whatsoever on the Site, and the term of the land use right is fifty (50) years. The JVC will obtain the transferrable and collateralizable land use right over the Site in accordance with this Contract. Party A shall be responsible for all taxes and expenses in connection with the transfer of the land use right over the site and ownership of the factory buildings and facilities to the JVC and indemnify and reimburse Party B against any losses or liabilities incurred by the JVC arising relating to the taxes and expenses.
11.3. Party A has entered into the Grant of State-owned Land use right Contract related to the land use right over the Site described in Appendix C hereto with the Shanghai Municipal Land Resources Bureau, pursuant to which Party A has been granted the land use right and the land use right certificate for the site stated in Appendix C hereto. Party A has provided to Party B and the JVC the copies of the Grant of State-owned Land use right Contract, as well as confirmation from the Shanghai Municipal Land Resources Bureau that Party A has paid in full the land use right premium and related taxes and expenses.
11.4. Party A has entered into the Transfer Contract with the JVC, pursuant to which, the JVC may apply to the Shanghai Municipal Land Resources Bureau for the land use right certificate, the real estate ownership certificate and the boundary map related to the Site sated in Appendix C hereto, certifying that the JVC has the following land use right over the Site stated in Appendix C hereto:
(1) the land use right is obtained through transfer with consideration;
(2) the term of land use right is fifty (50) years from the date of issuance of the land use certificate to the JVC;
(3) the permitted land use satisfies the needs of the JVC to operate the traditional Chinese medicine business as stated in Section 3.2 herein;
(4) the land use right is transferrable and collateralizable subject to the PRC laws; and
(5) the JVC owns the titles of the housing and buildings (including those under construction) listed in Appendix C hereto during the term of land use right.
CHAPTER 12
PURCHASE OF EQUIPMENT AND MATERIAL
12.1. In its purchase or lease of the required production equipment, raw materials, parts and components and services, the JVC shall give priority to purchasing or leasing them in China, unless the terms on price, quality, reliability, service, and maintenance and delivery time available in China are less favourable than those available aboard, and under which case, subject to Section 8.11 (10) herein, the General Manager has the right to decide to purchase them from abroad.
CHAPTER 13
CONTRACTING WITH THIRD PARTIES
13.1. Except as otherwise provided herein or in the Articles of Association, the General Manager may enter into any contract or make any undertaking with a third party on behalf of or under the name of the JVC for matters in connection with the day-to-day operations and management of the JVC, provided that the General Manager shall submit the material contracts and undertakings of the JVC to the Board of Directors for review and approval and such contracts and undertakings shall be executed by the Chairman of the Board or its authorized person.
CHAPTER 14
LABOUR MANAGEMENT
14.1. Policies and procedures for the hiring, employment, dismissal, remuneration, labour insurance, welfare and benefits, penalty, rewards and other matters shall be
formulated by the General Manager in accordance with the Labour Law of the Peoples Republic of China and other relevant provisions, and submitted to the Board of Directors for approval.
14.2. Pursuant to Chapter 13 of the Regulations for the Implementation of the Law of the Peoples Republic of China on Chinese-foreign Equity Joint Ventures, employees of the JVC who are qualified to join labour unions shall have the right to establish a labour union to represent their interests and to carry out labour union activities and other activities permitted by the PRC laws.
The JVC shall allocate funds to the labour union in accordance with the laws and regulations.
14.3. The General Manager, within the authority delegated to him by the Board of Directors, shall have the sole discretion to determine, in accordance with the PRC labour management laws and Board resolutions, the conditions of employment of the employees of the JVC, internal rules, procedures and standards for hiring, firing and disciplining employees, their work arrangements and leave, etc.
14.4. Subject to the approval by the Board of Directors and under conditions of economy and efficiency, in hiring its employees, the JVC shall give priority to Party As employees based on merit. Party A may also conduct public recruitment. The Parties agree that Party B shall pay to the JVC and the JVC shall in turn pay to Party A [**] Yuan to be used toward the redundancy payment for Party As Redundant Employees (Please refer to Appendix K Placement and Compensation Contract for details). JVC has autonomy to recruit any employee to fill a position at any time without any constraint, and Party A, its Associated Company or its Affiliate will not object or hinder the JVC from recruiting any employee who has worked for Shanghai Pharmaceuticals Holding Co., Ltd. its Affiliate or Associated Company.
14.5. The engagement of the General Manager of the JVC and his/her wages and benefits, social insurance, welfare and business travel expenses shall be discussed and decided by the Board pursuant to the prevailing market conditions.
CHAPTER 15
TAXES
15.1. The JVC shall pay various taxes in accordance with the PRC laws and regulations and shall enjoy all preferential policies and treatment provided by the PRC government and Shanghai Municipality government.
15.2. Employees of the JVC shall pay individual income tax in accordance with the Individual Income Tax Law of the Peoples Republic of China.
CHAPTER 16
FINANCIAL AFFAIRS AND ACCOUNTING
16.1. The JVC shall establish an accounting organization, provide itself with accounting personnel and formulate its accounting system in accordance with the Accounting System of the PRC for Chinese-foreign Equity Joint Ventures and in the light of its own actual circumstances. The accounting system of the JVC must be filed for record with the Shanghai Finance Bureau and Shanghai Taxation Bureau.
16.2. The JVC shall prepare monthly, quarterly and annual financial statements, including a profit and loss statement, cash flow statement, balance sheet, and other forms.
The Board of Directors shall engage a PRC qualified and registered public accounting firm as an independent auditor which shall examine and verify the annual financial reports of the JVC in accordance with the PRC laws and by reference to internationally used accounting methods. In addition, the JVC shall allow an internationally or PRC qualified auditor appointed by each Investing Party to examine its records, provided that, the Board of Directors will be given prior notice of such examination and the expenses incurred therefrom will be borne by the Investing Party which requests the examination.
The annual financial reports and examination reports shall be delivered to each Director at least seven (7) days before the same are submitted to the Board of Directors for approval.
The Annual financial reports and annual audit reports which have been approved by the Board of Directors shall be delivered to the Parties and the relevant governmental authorities for filing according to laws or regulations.
16.3. All expenditure documents of the JVC shall be valid only if signed by the General Manager or a person authorized thereby. The JVC shall use the invoices issued by the tax authority as evidence of receipt and payment. The invoices issued for the oversea (including Hong Kong and Macao) purchase of merchandise such as machinery, equipment, parts and components (where the custom declaration is required) will be deemed valid only if supported by declaration forms with the PRC ports of entry or custom declaration forms with the PRC customs.
16.4. The JVC shall adopt the internationally used accrual basis of accounting and the debit and credit method of keeping accounts in its accounting. All vouchers, books, receipts, statements and other accounting documents shall be written in Chinese. The JVC shall use Renminbi as its standard bookkeeping currency.
16.5. Except for the first year of the establishment of the JVC, the fiscal year of the JVC shall run from January 1 to December 31 of the Gregorian calendar year.
16.6. Net Profits of the JVC refers to the balance of gross income less all necessary business expenditure (including depreciation), losses from previous years and taxes.
16.7. Each year, the JVC shall set aside out of its Net Profits certain amount for the Three Funds, the total of which shall not exceed [**] of the Net Profits for that year. The specific amounts of the Three Funds set aside and their percentages shall be decided by the Board of Directors subject to relevant laws. In the event of the liquidation of the JVC, any unused portion of the reserve fund and expansion fund shall be treated as part of the assets of the JVC.
16.8. After deduction of the Three Funds, the remaining Net Profits of the JVC shall be distributed to the Parties in proportion to their respective contribution to the JVC. Except as otherwise determined by the Board of Directors, the JVCs profit distribution shall be no less than [**] of its Net Profits. Any balance of the Net Profits shall be retained by the JVC for use in its business development.
CHAPTER 17
FOREIGN EXCHANGE
17.1. All matters in relation to foreign exchange of the JVC shall be handled in accordance with the Regulations on Foreign Exchange Administration of the Peoples Republic of China and other relevant regulations.
17.2. The JVC shall open a foreign currency account with a bank which is authorized by Chinese laws and regulations to accept foreign exchange business. The foreign exchange revenue of the JVC shall be deposited in such account.
17.3. After paying relevant income tax and other expenses, the Parties shall assist the foreign and Hong Kong expatriate of the JVC in applying for permission to remit abroad their remaining income in accordance with the relevant regulations of China.
17.4. In accordance with the relevant regulations of the Chinese government, Party B may freely remit abroad the foreign dividends derived from the JVC.
17.5. The JVC shall exert its best efforts to balance its foreign exchange receipts and expenditures and generate profits. If the JVC is unable to balance its foreign exchange, the Parties shall consult and consider implementing other means to achieve such balance, including all means permitted under the Regulations Concerning the Issues of Balancing Foreign Exchange Receipts and Expenditures for Sino-foreign Joint Venture Enterprises and other relevant regulations.
CHAPTER 18
EFFECTIVE DATE, TERM AND TERMINATION
18.1. This Contract shall come into effect on the date of approval noted on the approval certificate issued by the relevant governmental authority.
18.2. The term of this Contract shall be fifty (50) years, commencing from the Date of Establishment of the JVC. Upon expiry of the Joint Venture Term, the Parties may consult to each other and decide to apply for extension of the Joint Venture Term.
If the Investing Parties unanimously agree to extend the Joint Venture Term, and after a resolution to that effect is adopted at a Board meeting, a written application shall be submitted to the Examination and Approval Authority six (6) months prior to expiry of the Joint Venture Term. The term shall be extended only upon approval of such application. The procedures for amendment of registration shall be carried out with the registration authority.
18.3. If both Investing Parties consider it to be in their best interests to terminate the JVC, they may terminate the JVC early.
In the case of such early termination, a resolution to that effect shall be adopted by unanimous approval of all Directors in attendance at a Board meeting, and such early termination shall be reported to the Examination and Approval Authority for approval.
18.4. This Contract may be terminated prior to expiry if:
(1) Party A or Party B becomes bankrupt, shutdown or is liquidated; or a major portion of its property connected with the JVCs business is acquired, arrested, appropriated or requisitioned by any third party; or such portion of its property has been taken over control by an appointed receiver. In each case above, the Party affected may terminate the Contract by giving written notice to the other Party. Such termination shall take effect thirty (30) days after the date next following date of receipt of the termination notice.
(2) either Party materially breaches any provision of this Contract, in which case the other Party shall have the right to terminate this Contract within ninety (90) days following its discovery of the breach, provided that it gives the breaching Party not less than sixty (60) days advance written notice, and if the breaching Party cures such breach within the time limit for termination stipulated in the written notice, such notice of termination shall be deemed void;
(3) either Party attempts or takes any step to transfer its equity held in the JVC in violation of any of the provisions set forth in this Contract;
(4) part or all of the assets of the JVC are expropriated by governmental authorities for a long period of time;
(5) any competent governmental authority requires any Party to revise any provisions of this Contract or impose any conditions or restrictions on the implementation of this Contract, causing material adverse consequences to the JVC or any Parties benefits;
(6) the JVC is unable to continue its business operations due to its inability to make up the accumulated losses or occurrence of irreparable serious damages to its assets; and
(7) the JVC is rendered unable to continue its normal operation by an event or its consequence of force majeure as set forth in Section 22.1 herein which continues in existence for over one hundred and eighty (180) days.
18.5. If either Party has issued a notice to terminate Contract, the Parties shall negotiate and endeavour to eliminate the cause for termination within two (2) months from the date of the issuance of such notice. If, by the end of the two (2) month period, the Parties fail to reach an agreement to resolve the issues, the Board shall submit an application for early termination to the Examination and Approval Authority. In addition, the provisions set out in Section 18.6 below shall be applied.
18.6. If the Joint Venture Term is not extended pursuant to Section 18.2 or the Parties fail to reach a negotiated solution after either Party has delivered a notice of early termination pursuant to Section 18.5, the JVC shall continue to operate only if a Party (the Purchaser) notify the other Party (the Seller) that it intends to acquire the Sellers interests in the JVC (the Acquisition Notice), and acquisition of such interests shall be proceeded on the following terms and conditions:
(1) the Parties shall negotiate a purchase price satisfactory to both Parties. If Party A and Party B fail to reach a mutually acceptable purchase price within one (1) month from the date of the receipt of the Acquisition Notice, the purchase price shall be determined pursuant to (2) below;
(2) Party A or Party B may each, within two (2) months from the date of the Acquisition Notice, appoint a PRC-qualified accounting firm or an assessor registered in China in writing to conduct a joint valuation on the JVC and notify the Purchaser of such appointment. The Party which fails to appoint any accounting firm or assessor is deemed to have waived its right of appointment. The joint valuation shall be completed within one (1) month from the date of appointment and shall be made based on the assumption that the JVC remains in business as a going concern. The purchase price shall be equal to the product of a) value of the JVC as determined based on the joint valuation multiplied by b)the percentage of registered capital held by the Seller at that time;
(3) unless otherwise agreed in writing by both Parties, ten percent (10%) of the purchase price determined in accordance with (1) and (2) above of this Section shall be paid within seven (7) days following the execution of relevant contract, and forty percent (40%) of the purchase price shall be paid within three (3) months, and the balance shall be paid within six (6) months;
(4) if Party B is the Seller, the purchase price shall be paid in US dollars or Hong Kong Dollars, and the related matters shall be handled in accordance with the relevant PRC laws.
(5) if Parties fail to reach an agreement on the purchase price pursuant to above provisions, or if the purchase price is agreed but the Seller does not receive
the full amount of the purchase price as stated above, the JVC shall be liquidated in accordance with Chapter 19 herein.
18.7. Before the JVC is liquidated, the Investing Parties shall continue to perform their respective obligations and exercise their rights, and ensure the ordinary operation of the JVC.
CHAPTER 19
LIQUIDATION AND DISPOSAL OF THE ASSETS OF THE JOINT VENTURE COMPANY
19.1. In the event of the early termination of the Contract or upon expiry of the Joint Venture Term, the Board of Directors shall establish a liquidation committee which has the authority to represent the JVC in all legal matter and shall value and liquidate the JVCs assets in accordance with the PRC laws and regulations and the principles set out herein.
19.2. The liquidation committee shall be made up of six (6) members, of which three (3) members shall be appointed by Party A and three (3) members shall be appointed by Party B. Members of the liquidation committee may, but need not, be the Directors of the JVC. Either Party may also appoint professional advisors, such as accountants and lawyers qualified either in China or abroad, to assist the liquidation committee.
19.3. The liquidation committee shall conduct a thorough examination of the JVCs assets and liabilities, on the basis of which it shall develop a liquidation plan which, if approved by the Board of Directors, shall be executed under the liquidation committees supervision.
19.4. In developing and executing the liquidation plan, the liquidation committee shall use every effort to sell the JVCs assets and business at the highest possible price in foreign currencies. Considerations shall be given to sale of the JVCs assets or business by public auction or by tender open to domestic and foreign bidders with a view towards obtaining the selling price at international market rates. If necessary, Renminbi shall be converted to foreign exchange in accordance with the relevant laws and regulations of China. Any expenses related to the conversion of Renminbi to foreign exchange shall be considered as liquidation expenses.
19.5. The liquidation expenses, including remuneration to members of the liquidation committee, shall be paid out of the JVCs assets in priority to the claims of other creditors.
19.6. After the liquidation or division of the JVCs assets and the settlement of all of its outstanding debts, the balance of the JVCs assets (if any) shall be paid to the Parties in proportion to their respective contributions to the registered capital of the JVC. The Party which has made its contribution to the JVC in foreign currency shall have the priority to be paid in foreign currency.
19.7. On completion of all liquidation procedures, the liquidation committee shall submit a final report approved by the Board to the Examination and Approval Authority, and hand in the JVCs Business License to the original registration authority and complete all other formalities for nullifying the JVCs registration. Party B shall have a right to obtain copies of all of the JVCs accounting books and other documents but the originals thereto shall be left in the care of Party A.
19.8. Upon the expiry or termination of the JVC, or in case that Party B ceases holding at least fifty percent (50%) of the share in the registered capital of the JVC, the JVC shall change its name immediately to a name not including the character 和黄 or the syllable HUTCHISON or any word resembling in any manner the character 和黄 or its syllable HUTCHISON . Party A undertakes, under no circumstance, it will use the character 和黄 or the syllable HUTCHISON or any resembling word as its corporate name to continue or take over the business of the JVC. The JVC and the Parties agree to take actions necessary to fulfil this undertaking.
19.9. It is agreed by both Parties that Party B may continue to use the name character 和黄 or the syllable HUTCHISON in any of its activities within China as freely as it does outside China.
CHAPTER 20
INSURANCE
20.1. Each insurance policy of the JVC shall be taken out by the JVC from the insurance company which it considers most suitable as permitted by Chinese law. The risks insured, insured values, coverage periods, etc., shall be discussed and decided at meetings of the JVCs Board of Directors in accordance with the policies of the insurance company.
CHAPTER 21
AMENDMENT OF THE CONTRACT
21.1. This Contract (including its appendices) may be amended only by written agreement executed by the Investing Parties. Such amendments shall come into effect upon the approval of the Examination and Approval Authority.
CHAPTER 22
FORCE MAJEURE
22.1. If, during the Joint Venture Term, the performance of this Contract is directly affected by, or this Contract cannot be performed on the agreed conditions due to, an earthquake, typhoon, flood, fire, war or other event of force majeure which cannot
be foreseen and the occurrence and consequences of which cannot be prevented or avoided, the Party affected by such event of force majeure shall promptly notify the other Party in writing of the details of such event and shall, within fifteen (15) days, provide detailed information on the event and a valid certificate attesting to the reason why the Contract cannot be performed or can only be partially performed or why the term for its performance needs to be extended. Such certificate shall be issued by the notarial organization of the place where the event of force majeure occurred. The Investing Parties shall consult with each other and decide whether this Contract shall be terminated or whether part of the obligation to perform this Contract shall be released or whether the term for performance of this Contract shall be extended, according to the extent of the impact of the event of force majeure on the performance of this Contract.
CHAPTER 23
SETTLEMENT OF DISPUTES AND GOVERNING LAW
23.1. Any dispute arising from this Contract shall be settled through friendly consultations. If a dispute cannot be settled within sixty (60) days after the commencement of consultations, then a Party to the dispute may submit it to the China International Economic and Trade Arbitration Commission in Beijing for arbitration in accordance with its arbitration procedures. Such arbitration shall be final and binding on both Parties.
23.2. During the period of arbitration of a dispute, the Investing Parties shall continue to perform their obligations hereunder, except for those obligations involved in the matter under dispute, and to exercise their rights hereunder.
23.3. The execution, validity, interpretation and performance of this Contract and the settlement of disputes related to this Contract shall all be protected and governed by the laws of the PRC.
23.4. The JVC and the Parties shall apply for any tax, investment and other benefits or preferences more favourable than the terms of this contract that become available or publicly known after date hereof.
CHAPTER 24
CONFIDENTIALITY
24.1. The Parties hereby agree that they shall not disclose to any third party any part of this Contract (including appendices), or any other agreements that either Party may be negotiating, or details of confidential negotiations in reaching such agreements, or any business or secrets disclosed by either Party, except as required by law or any stock exchange, or for purpose of preforming one Partys obligations under the abovementioned Contract or agreements. When such requirement to disclose has arisen, the disclosing Party shall obtain the other Partys written consent prior to the disclosure, which consent shall not unreasonable delayed.
24.2. The Parties shall cause their Directors and other Working personnel, and those of their Affiliates or Associated Companies to comply with the confidentiality obligation set forth in Section 24.1 above.
24.3. The obligation under the Section 24.1 shall survive the termination of this Contract and the termination and dissolution or liquidation of the JVC howsoever caused.
CHAPTER 25
BREACH OF CONTRACT
25.1. If a Party fails to perform any of its obligations under this Contract or if a Partys representation or warranty under this Contract is untrue or materially inaccurate, such Party shall be deemed to have breached this Contract. The breaching Party shall have thirty (30) days from receipt of notice from the other Parties specifying a breach to cure such breach (if curable). If a curable breach is not cured within thirty (30) days, the breaching Party shall indemnify the other party against any losses arising from such breach. If a breach is not curable, the breaching Party shall immediately indemnify the other party against any losses arising from such breach.
CHAPTER 26
GENERAL PROVISIONS
26.1. The invalidity of any provision of this Contract shall not affect the validity of any other provision of this Contract.
26.2. This Contract is written in Chinese.
26.3. This Contract and its Appendices attached hereto constitute the entire agreement between the Parties with respect to the subject matter of this Contract and supersede all prior discussions, negotiations and agreements between them.
26.4. Any notice or written communication provided under this Contract, including but not limited to any and all offers, writings, or notices to be given hereunder, shall be made in Chinese and/or English and promptly sent or delivered by one Party to another Party by facsimile, and shall be subsequently confirmed by registered air-mail. The date of receipt of a notice or communication hereunder shall be deemed to be twelve (12) days after its postmark in the case of an airmail letter and two (2) working days after dispatch in the case of a telex or facsimile. All the notices and communications shall be sent to the appropriate address telex or facsimile numbers first above written, until the same is changed by notice given in writing to the other Party.
CHAPTER 27
APPENDICES
27.1. The following Appendices constitute a part of this Contract. In the event of a discrepancy between the interpretation of the provisions of the Appendices attached hereto and the provisions of this Contract, this Contract shall prevail.
Appendix A: |
Party As Assets |
Appendix B: |
Party As Contracts |
Appendix C: |
Site, Houses and Buildings |
Appendix D: |
Catalogue of [**] Products Produced by the JVC |
Appendix E: |
Contribution Schedule |
Appendix F: |
Feasibility Study Report |
Appendix G: |
Trademark Transfer Agreement |
Appendix H: |
License Agreement for the Trademark of Shanghai Pharma |
Appendix I: |
List of Two Certificate, Product Certificate or Product Approval |
Appendix J: |
List of Inventory of Packaging Materials |
Appendix K: |
Placement and Compensation Contract |
IN WITNESS WHEREOF , the Investing Parties have caused this Contract to be executed as of the date first above written by their duly authorized representatives.
THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
English Translation
FOURTH AMENDMENT TO JOINT VENTURE CONTRACT
THIS FOURTH AMENDMENT TO JOINT VENTURE CONTRACT (the Amendment No.4) is entered into by and between the following Parties in Shanghai Municipality, China on March 8, 2013:
1. Shanghai Traditional Chinese Medicine Co., Ltd., a corporate legal person registered in Shanghai Municipality, China, with its registered address at 239 Hankou Road, Shanghai Municipality, China (Party A); and
2. Shanghai Hutchison Chinese Medicine (HK) Investment Limited, a limited company registered in Hong Kong, with its registered address at 22nd Floor, Hutchison House, 10 Harcourt Road, Central, Hong Kong (Party B).
WHEREAS,
3. Party A and Hutchison Chinese Medicine (Shanghai) Investment Limited (the Original Party B) entered into the Joint Venture Contract (the JVC Contract) relating to the formation of Shanghai Hutchison Pharmaceuticals Limited (the JVC) as the date of January 6, 2001;
4. The JVC obtained the Approval Certificate of Foreign-invested Enterprise on March 19, 2001 and the Business Licence for Corporate Legal Person on April 30, 2001;
5. Party A and Original Party B entered into the First Amendment to Joint Venture Contract on July 12, 2001 (the Amendment No.1) ;
6. Party A and Party B entered into the Second Amendment to Joint Venture Contract December 5, 2007 (the Amendment No.2);
7. Party A and Party B entered into the Third Amendment to Joint Venture Contract on June 19, 2012 (together with the JVC Contract, the Amendment No.1 and the Amendment No.2 collectively referred to as the Original Contract); and
8. Party A and Party B desire to amend the Original Contract to reflect the Parties intention of increasing the registered capital of the JVC and the fact that Party A has changed its legal representative.
NOW THEREFORE, the Parties agree to the following terms and conditions:
1. The Parties agree that the first page of the Original Contract is hereby amended as follows:
Original: THIS EQUITY JOINT CONTRACT (the Contract) is jointly signed in Shanghai Municipality, Peoples Republic of China on this sixth day of January 2001 by and between Shanghai Traditional Chinese Medicine Co.,
Ltd. and Hutchison Chinese Medicine (Shanghai) Investment Limited, amended for the first time on July 12, 2001 by and between Shanghai Traditional Chinese Medicine Co., Ltd. and Hutchison Chinese Medicine (Shanghai) Investment Limited, amended for the second time on November 5, 2007 by and between Shanghai Traditional Chinese Medicine Co., Ltd. and Shanghai Hutchison Chinese Medicine (HK) Investment Limited, and amended for the third time on June 19, 2012.
The Parties of this Contract are:
Party A: Shanghai Traditional Chinese Medicine Co., Ltd., a corporate legal person established and existing pursuant to the laws of the PRC and registered with the Shanghai Municipal Administration for Industry and Commerce, China, with its legal address at 239 Hankou Road, Shanghai Municipality.
Legal representative
Name: Mr. Li Yongzhong
Title: Chairman
Nationality: Chinese
Party B: Shanghai Hutchison Chinese Medicine (HK) Investment Limited, a limited liability company established and existing pursuant to the laws of Hong Kong, with its registered address at 22nd Floor, Hutchison House, 10 Harcourt Road, Central, Hong Kong.
The authorized legal representative for this Contract:
Name: Mr. Simon To Chi Keung
Title: Board Director
Nationality: British
Amendment: THIS EQUITY JOINT CONTRACT (Contract) is jointly signed in Shanghai Municipality, Peoples Republic of China on the sixth day of January 2001 by and between Shanghai Traditional Chinese Medicine Co., Ltd. and Hutchison Chinese Medicine (Shanghai) Investment Limited, amended for the first time on July 12, 2001 by and between Shanghai Traditional Chinese Medicine Co., Ltd. and Hutchison Chinese Medicine (Shanghai) Investment Limited, amended for the second time on November 5, 2007 by and between Shanghai Traditional Chinese Medicine Co., Ltd. and Shanghai Hutchison Chinese Medicine (HK) Investment Limited,
amended for the third time on June 19, 2012, and amended for the fourth time on March 8, 2013.
The Parties of this Contract are:
Party A: Shanghai Traditional Chinese Medicine Co., Ltd., a corporate legal person established and existing pursuant to the laws of the PRC and registered with the Shanghai Municipal Administration for Industry and Commerce, China, with its legal address at 239 Hankou Road, Shanghai Municipality, China
The authorized legal representative for this Contract:
Name: Mr. Chen Junli
Title: Chairman
Nationality: Chinese
Party B: Shanghai Hutchison Chinese Medicine (HK) Investment Limited, a limited liability company established and existing pursuant to the laws of Hong Kong, with its registered address at 22nd Floor, Hutchison House, 10 Harcourt Road, Central, Hong Kong
The authorized legal representative for this Contract:
Name: Mr. Simon To Chi Keung
Title: Board Director
Nationality: British
2. The Parties agree Section 4.01 of Chapter 4 of the Original Contract is hereby amended as follows:
Original: The total amount of investment of the JVC shall be [**]
Amendment: The total amount of investment of the JVC was [**] at the time of the incorporation of the JVC. The total amount of investment shall be increased by [**], and after the increase, the total amount of investment of the JVC shall be [**].
3. The Parties agree Section 4.02 of Chapter 4 of the Original Contract is hereby amended as follows:
Original: The total amount of the JVCs registered capital shall be [**].
Amendment: The total amount of the JVCs registered capital was [**] at the time of the incorporation of the JVC, which was fully paid up. The JVC will increase its registered capital by [**], and each Party agrees to subscribe for 50% of the increase in the registered capital (i.e. [**]) and to make the contribution out of JVCs after-tax profits distributed to it. After the capital increase, the JVCs registered capital shall be [**]. Party A and Party B shall make their capital contributions they subscribed for to the increase in the registered capital on a one-time basis before the JVC has applied for registration for change in the registered capital.
4. The terms and conditions of the Original Contract, not amended by the Amendment No, 4, shall remain in full force and effect. This Amendment No.4 is the integral part of the Original Contract.
5. The validity, interpretation, performance and settlement of disputes relating to this Amendment No.4 shall be governed by the laws of the Peoples Republic of China.
6. The Amendment No.4 shall be executed by the duly authorized representatives of the Parties and become effective upon the approval of the examination and approval authority. The Parties may enter into supplemental agreements for matters not covered herein.
7. There shall be six copies of the Amendment No.4, with each Party and the JVC holding one copy, and the remaining will be filed with the relevant governmental authorities for record.
8. This Amendment No.4 is signed by the authorized representatives of Party A and Party B as of the date stated on the first
Party A: Shanghai Traditional Chinese Medicine Co., Ltd.
Legal Representative: Chen Junli
/s/ Chen Junli |
|
(Signature and Seal) |
|
Party B: Shanghai Hutchison Chinese Medicine (HK) Investment Limited
Authorized Legal Representative: Simon To Chi Keung
/s/ Simon To Chi Keung |
|
(Signature and Seal) |
|
March 8, 2013
THE SYMBOL [**] DENOTES PLACES WHERE CERTAIN IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THE EXHIBIT BECAUSE IT IS BOTH (i) NOT MATERIAL AND (ii) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED
English Translation
Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited
Equity Joint Venture Contract
December 18 , 2013
Table of Contents
Equity Joint Venture Contract
T HIS EQUITY JOINT VENTURE CONTRACT (this Contract or the Contract) is jointly signed in Shanghai, the Peoples Republic of China on this 18 th day of December, 2013 by and between:
Party A: Sinopharm Group Co., Ltd., an enterprise legal person duly established and existing under the laws of Peoples Republic of China and registered with Shanghai Municipal Administration for Industry and Commerce, with its legal address at 6F, 221 Fuzhou Road, Huangpu District, Shanghai, China; legal representative: WEI Yulin; title: Chairman; facsimile: (86-21) 23052241.
Party B: Hutchison Chinese Medicine GSP (HK) Holdings Limited, a limited liability company duly established under the laws of Hong Kong, with its legal address at 22F, Hutchison House, 10 Harcourt Road, Central, Hong Kong; legal representative : Christian Lawrence Hogg; title: Director; facsimile: (852) 2121-8281.
Preamble
In accordance with the Law of Peoples Republic of China on Sino-foreign Equity Joint Venture Enterprises , the implementing regulations issued thereunder, the Provisions on Merger and Acquisition of Domestic Enterprises by Foreign Investors, and other applicable laws and regulations of the Peoples Republic of China, the aforesaid Parties, adhering to the principles of equality and mutual benefit and through friendly consultations, agree to, by way of subscription of the Increased Registered Capital (defined below), covert the Sinopharm Holdings Huyong Pharmaceutical (Shanghai) Co., Ltd. into a Sino-foreign joint venture company in which Party A will hold 49% of the equity and Party B will hold 51% of the equity on the following terms and conditions.
CHAPTER I
DEFINITIONS
For the purpose of this Contract, the following terms shall have the following meanings:
1.1. Subsidiary shall mean any company controlled directly or indirectly by any Party of this Contract. Control shall mean having, directly or indirectly, ownership of more than fifty percent (50%) of the equity interests or control power or management power.
1.2. Affiliate shall mean any company which is controlling, controlled by or under common control with any Party hereof. Control shall have the meaning ascribed to it in Section 1.01 hereof.
1.3. Associate Company shall mean any company in which any Party of this Contract holds, directly or indirectly, more than 20% and less than 50% of equity interests.
1.4. Parties hereto or Parties shall mean Party A and Party B. A Party hereto or Party shall mean Party A or Party B, as the context may require.
1.5. Investing Party or Investing Parties shall mean Party A or Party B or both Party A and Party B, as the context may require.
1.6. Shanghai Huyong shall mean Sinopharm Holdings Huyong Pharmaceutical (Shanghai) Co., Ltd., which is currently a limited liability company wholly owned by Party A.
1.7. JVC shall mean Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited, a Sino-foreign joint venture company converted from Shanghai Huyong through subscription of the Increased Registered Capital thereof by the Investing Parties according to this Contract.
1.8. Investment shall mean the actual capital contributions made by the Parties to the JVC and the Parties ownership percentage in the JVC in proportion to their contributions to the JVC.
1.9. Articles of Association shall mean the Articles of Association of the JVC which is executed by the Parties concurrently with the execution of this Contract.
1.10. this Contract or the Contract shall mean the main body of this Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited Joint Venture Contract and all appendices attached hereto.
1.11. Capital Increase Agreement shall mean Hutchison Whampoa Sinopharm Pharmaceuticals (Shanghai) Company Limited Capital Increase Agreement which is executed by the Parties concurrently with the execution of this Contract.
1.12. Board of Directors or Board shall mean the Board of Directors of the JVC consisted of the Directors nominated by the Investing Parties hereto.
1.13. Appraisal Report shall mean the Appraisal Report of Enterprise Value (Hu Dongzhou Asset Appraisal Report Zi[2013] No.0534121) issued by Shanghai Dongzhou Asset Appraisal Co., Ltd. on October 15, 2013 attached hereto as Appendix A.
1.14. Appraisal Date shall mean December 31, 2012.
1.15. Effective Date shall mean the approval date specified in the Foreign-invested Enterprise Approval Certificate issued by the Approval Authority (defined in Section 1.14 below) to the JVC upon the approval of this Contract, Articles of Association and the Capital Increase Agreement.
1.16. Date of Establishment shall mean the date of issuance of the renewed business license to the JVC after the conversion of Shanghai Huyong into a Sino-foreign joint venture company (the renewed business license specifies the nature of the company is a Sino-foreign joint venture company with the registered capital of [**] ).
1.17. Approval Authority shall mean the Ministry of Commerce of the PRC and the affiliated agency authorized by it with the approval authority to approve specific matters.
1.18. Joint Venture Term shall mean the term set forth in Section 18.02 hereunder or that term as may be extended or shortened pursuant to Section 18.02, 18.03 or Section 18.04 hereunder.
1.19. Renminbi or RMB shall mean the lawful currency of the PRC.
1.20. SAFE shall mean the State Administration of Foreign Exchange of PRC or its Shanghai Municipal branch.
1.21. Working Personnel shall mean all workers and other staff of the JVC, including personnel seconded to the JVC by either Party, except for the Directors and Senior Personnel.
1.22. Three Funds shall mean the reserve fund, enterprise development fund and employee bonus and welfare fund.
1.23. PRC or China shall mean the Peoples Republic of China.
1.24. Hong Kong shall mean Hong Kong Special Administrative Region of the Peoples Republic of China.
1.25. PRC Laws shall mean all current effective laws, regulations, administrative rules, regulatory document, judicial interpretations and other legally-binding decisions formulated and published by the legislative bodies, governments at all levels and their functional departments, the Supreme Peoples Court and the Supreme Peoples Procuratorate.
CHAPTER II
ESTABLISHEMENT OF THE JOINT VENTURE COMPANY
2.1. In accordance with the Law of Peoples Republic of China on Sino-foreign Equity Joint Venture Enterprises, the implementing regulations issued thereunder, the Provisions on Merger and Acquisition of Domestic Enterprises by Foreign Investors and other applicable PRC Laws, the Parties, adhering to the principles of equality and mutual benefit and through friendly consultations, agree to convert the Shanghai Huyong into a joint venture company invested and operated by both Parties through the subscription of the Increased Registered Capital (defined below) of Shanghai Hongyu by Party B.
2.2. The JVC will apply for the alteration of registration with the Shanghai Municipal Administration for Industry and Commerce, China. All activities in China of the JVC shall be conducted in compliance with PRC Laws and be governed and protected by PRC Laws.
2.3. The JVC shall be a limited liability company. The liability of the Investing Parties shall be limited to the amounts of their respective capital contributions. The JVC shall bear all the liabilities with all its assets.
2.4. The profits, risks, and losses shall be shared by the Investing Parties in proportion (49% :51%) to their respective ownership percentage on the condition that Party A and Party B has performed their obligations of paying capital contributions according to the Section 4.04 hereof.
2.5. The JVC shall be an independent economic entity. It shall be entitled to all preferential treatment granted to the Sino-foreign joint venture enterprises by Shanghai Municipal Peoples Government. The JVC shall have full autonomy in its business operations, and shall have the right to decide on its business strategies in accordance with its own best interests.
2.6. The Chinese name of the JVC is: 国 药 控股和 记 黄埔医 药 (上海)有限公司 . The English name of the JVC is: HUTCHISON WHAMPOA SINOPHARM PHARMACEUTICALS (SHANGHAI) COMPANY LIMITED.
2.7. The legal address of the JVC is Tower 1, 563 Jujiaqiao Road, Pudong New District, Shanghai, China.
CHAPTER III
PURPOSE AND SCOPE OF BUSINESS
OF THE JOINT VENTURE COMPANY
3.1. The purpose of the JVC shall be, through the joint venture of both Parties, to strengthen the economic cooperation and technology communications, to promote the development and modernization of Chinas pharmaceutical and healthcare industry; to use advanced technologies, equipment and devices to absorb the advanced management experience and method from abroad, so as to bring satisfactory economic benefits to the Parties.
3.2. The scope of business of the JVC shall be wholesale of traditional Chinese medicine preparations, chemical medicine preparations, antibiotics, biochemical drugs, biological products (subject to license where a license is required); sales of medical devices (see license for business scope, subject to license where a license is required); sales of pre-packaged food (except for cooked foods and pot-stewed foods, chilled and frozen) (subject to license where a license is required); sales of daily necessities; import and export of goods and technologies; cargo agency; warehousing (except for hazardous materials); business information consultation, investment consultation (except for brokerage services); exhibition services; computer software and hardware development; setup of branches.
The above scope of business shall be subject to the final approval of the competent Approval Authority.
CHAPTER IV
TOTAL AMOUNT OF INVESTMENT
AND REGISTERED CAPITAL
4.1. The total amount of investment of the JVC shall be [**].
4.2. The registered capital of the JVC shall be [**] (comprised of [**] of Shanghai Huyongs current paid-in capital and [**] of the increased registered capital (the Increased Registered Capital) issued to and subscribed by Party B in order to convert Shanghai Huyongs into the JVC).
4.3. The capital contributions and ownership percentage of each Party shall be as follows:
(1) Party As contribution to the JVCs registered capital shall be [**] (which has been fully paid up by Party A), representing forty-nine percent (49%) of the registered capital; and
(2) Party Bs contribution to the JVCs registered capital shall be [**], representing fifty-one percent (51%) of the registered capital.
4.4. Each Party shall make its capital contribution and provide or raise funds as required by the operation of the JVC as follows:
(1) Each Party shall make its capital contribution at the time of the incorporation of the JVC as follows:
Party A has contributed [**] to Shanghai Huyongs registered capital. At the stage of Shanghai Huyongs conversion into the JVC, the Parties agree that Party A is not required to make any additional contribution.
Party B shall make a cash contribution of [**] to the JVC, of which [**] will be contributed to the Increased Registered Capital for Shanghai Huyongs conversion into the JVC and the balance of [**] will included in the capital reserve account of the JVC.
Party B shall make contribution of 20% of the Increased Registered Capital (i.e.[**]) after this Contract, Articles of Association and Capital Increase Agreement become effective, and Shanghai Huyong has applied for the foreign-invested enterprise basic information registration with the foreign exchange administration office at its place of registration and opened a special deposit account for Renminbi capital funds (Party A and Party B shall each designate an authorized signatory for such account, and all payment orders in relation to such account will be valid only if jointly signed by the two authorized signatories), but before Shanghai Huyong has applies for the registration of the conversion into a joint venture enterprise with the Shanghai Municipal Administration for Industry and Commerce. Party B shall contribute in full the balance of the Increased Registered Capital and the amount for capital reserve in total of [**] within five
(5) working days after the establishment of the JVC and the completion of the delivery by the Parties as described in Section 13.05 hereunder. Party Bs failure to pay its contribution on time or in full in accordance with the provisions hereof would constitute a breach of the Contract. Party A shall have the right to demand Party B to pay its contribution in full within one (1) month (the Extended Period). In case Party B still fails to pay in full within the Extended Period, Party A shall have the right to apply with the competent Approval Authority for approval to terminate this Contract, Articles of Association and Capital Increase Agreement, and convert the JVC into the single-member limited liability company wholly owned by Party A. By then, the JVC shall return Party B all capital it actually contributed to the JVC (if any) within five (5) working days from the date of the Approval Authoritys issuance of the approval.
(2) Both Parties shall provide or raise funds for the difference between the total investment amount and registered capital through shareholders loans or by other ways according to the following principles:
Where possible, the JVC shall obtain loan from the financial institutions registered in China that may be required to finance its operation. In case the shareholders are required to provide guarantees in order for the JVC to obtain loan or other financial instruments, the Parties shall provide guarantees in proportion to their respective ownership percentage in the JVC. In case either Party fails to provide guarantee in accordance with the above provisions (referred to as Non-Providing Party in this Section), the other Party (referred to as Providing Party in this Section) may elect to provide guarantee on behalf of the Non-Providing Party. In such case, in consideration for Providing Partys provision of the guarantee, the JVC shall pay the Providing Party the guaranty fee calculated on a yearly basis as 2% of the amount of the loan guaranteed by it, and the JVC shall bear all taxes and expenses in relation to such guarantee fee. If creditors have enforced the guaranty against the Providing Party for payment of the amount guaranteed (whether in whole or in part, herein referred to as the Enforced Payment), a) the JVC shall refund the Enforced Payment to the Providing Party; b) the JVC shall pay the Providing Party interest on the Enforced Payment (as funds possession fees) at an interest rate same as the interest rate on bank loans of the same type and same term for a period ended on the date on which such Enforced Payment has been fully recovered from the JVC, and c) all taxes and expenses in relation to such payment of interest shall be borne by the
JVC. Instead of provision of guarantee, the Providing Party may elect to provide financial assistance to the JVC on behalf of the Non-Providing Party through shareholder loans. In such case, the JVC shall pay the Providing Party interest as compensations on the total amount of the loans at an interest rate same as the interest rate on the bank loans of the same term, and bear all taxes and expenses in relation to the payment of the interest.
In case the JVC is unable to obtain funds as described above, the Investing Parties shall provide the required funds to the JVC in proportion to their ownership percentage. If either Party fails to provide funds in accordance with the above provisions (referred to as Non-Providing Party in this Section), the other Party (referred to as Providing Party in this Section) shall have the right to elect a) to terminate this Contract and liquidate the JVC by giving written notice to the other Party, or b) to purchase the equity interests held by the Non-Providing Party in the JVC in accordance with the provisions of PRC Laws at a price based on valuation.
The JVC shall, upon Investing Parties request at any time, pay the principal and accrued interest on the above funds provided by the Parties on a pro rata basis (e.g., the principal and interest paid by the JVC to the Investing Parties shall be in proportions to their perspective contribution to the funds).
(3) The Parties agree that, if further registered capital is required for the operation and development of the JVC, each Party shall make additional capital contribution to the registered capital in proportion to their existing ownership percentage in the JVC. In case either Party fails to make additional capital contribution within its commitment period, with respect to the portion of the additional capital contributions that the Party fails to pay on time (hereinafter as Unpaid Capital), the contributing Party may elect, a) to contribute the Unpaid Capital to the JVCs registered capital, under which case, the ownership percentage shall be adjusted according to the paid-in capital of each Party (pain-in capital of each Party= the appraised value of their respective equity interest in the JVC prior to this capital increase as confirmed by the Parties + their respective actual contribution to the increase of the registered capital of the JVC), and the rights and obligations of each Party in the JVC (including without limitation, the number of Director each Party is entitled to appoint) shall also be adjusted accordingly; or b) to demand the non-contributing Party to make additional contribution and pay a default penalty of 0.05% of the Unpaid Capital per day.
4.5. After the Investing Parties have contributed their Investment, the JVC shall engage a PRC-registered public accounting firm to verify the contributions and to issue a capital verification report. On the basis of such investment verification report, the JVC shall issue Investment Share Certificates to both Parties, which shall specify the name and the Date of Establishment of the JVC, the name of the Investing Party obtaining the certificate, the amount of contributions and date on which such contributions are made, and the date of issuance of the Investment Share Certificate.
CHAPTER V
ASSIGNMENT OF INVESTMENT
5.1. If either Party (the Disposing Party) wishes to assign, sell or otherwise dispose of all or part of its Investment , the Disposing Party shall give the other Party written notice (the Assignment Notice) specifying the terms and conditions of the assignment, and the other Party shall have the right of first refusal.
5.2. If the other Party has not exercised its right of first refusal within thirty (30) days from the receipt of the Assignment Notice, such Party shall be deemed to have agreed the assignment, and the Disposing Party may assign, sell or otherwise dispose of all or part of its Investment to any third party on terms and conditions not more favorable than the terms and conditions provided to the other Party. The Disposing Party shall provide the other Party with a copy of the written agreement signed with the purchaser /assignee.
5.3. Notwithstanding the foregoing, the Parties agree that Party A may assign all or part of its Investment to the Subsidiaries in which Party A holds 50% or more equity interests, and Party B may assign all or part of its Investment to the Subsidiaries in which its parent company Hutchison China MediTech Limited holds 50% or more equity interests (the Intra-Group Assignments). The Parties hereby agree to waive the right of first refusal with respect to the Intra-Group Assignments conducted by the other Party in accordance with the provisions of this Section, and undertake to procure their respectively designated Directors of the JVC to approve the Intra-Group Assignments. In the case of Intra-Group Assignments, the Disposing Party is not required to provide the written assignment agreement signed with the purchaser/assignee to the Other Party. However, prior to the execution of the above assignment agreement, the Disposing Party shall provide documents and materials to the other Party certifying relevant purchaser/assignee complies with the identity requirement for the Intra-Group Assignments (including registration certificates and shareholding structure chart, etc.)
5.4. In case either Party sells its Investment to a third party or otherwise disposes of its Investment, the Party shall undertake and procure relevant assignees to undertake:
(1) after the assignment of relevant Investment, the assignee will enjoy the rights and perform the obligation hereby conferred upon the shareholders, as if it were an original Party hereto.
(2) the business of the JVC or the performance of its contracts shall not be interrupted by the sale, assignment or otherwise disposal of such equity interests.
5.5. The sale, assignment, pledge or otherwise disposal of Investment by either Party shall be submitted to the Approval Authority for approval as prescribed by PRC Laws. After obtaining the approval from the Approval Authority, the JVC shall go through relevant modification registration formalities with Shanghai Municipal Administration for Industry and Commerce.
5.6. Without the consent from the other Party, neither Party may pledge, mortgage or otherwise encumber all or any part of interest in the JVC.
5.7. Unless otherwise provided in the above Sections, without the consent from the other Party, neither Party shall assign, sell all or part of its Investment to any third party.
CHAPTER VI
SPECIAL OBLIGATIONS OF THE PARTIES
6.1. Party A shall:
(1) [**]
(2) [**]
(3) [**]
(4) [**]
(5) [**]
(6) [**]
(7) [**]
6.2. Party B shall:
(1) [**]
(2) [**]
(3) [**]
(4) [**]
(5) [**]
(6) [**]
CHAPTER VII
REPRESENTATIONS, WARRANTIES AND UNDERTAKING
7.1. For the purpose of this Contract, Party A unconditionally and irrevocably represents and warrants, acknowledges to Party B as follows:
(1) Party A is a company limited by shares duly incorporated and existing in accordance with PRC Law and having an independent legal personality;
(2) Party A has the power and legal capacity to execute and perform this Contract and other documents related to the Contract, to which Party A is a party;
(3) Party A has taken all measures and obtained all authorizations (including but not limited to measures, procedures, authorizations, approvals and permits required to be taken, fulfilled or obtained by its Articles of Association, listing rules of the relevant stock exchanges and applicable PRC Laws) required for executing this contract and all other documents to which Party A is a party;
(4) the documents and materials disclosed by Party A to Party B are all complete, true, accurate and valid in every material aspect; and
(5) Party A acknowledges Party B enters into this Contract with Party A in reliance upon the representations and warranties made by Party A under this Section 7.01.
7.2. For the purpose of this Contract, Party B unconditionally and irrevocably represents, and warrants and acknowledges to Party A as follows:
(1) Party B is a limited liability company duly incorporated and existing in accordance with the laws of the Hong Kong Special Administrative Region and having an independent legal personality;
(2) Party B has the power and legal capacity to execute and perform this Contract and other documents related to the Contract, to which Party B is a party;
(3) Party B has taken all measures and obtained all authorizations (including but not limited to measures, procedures, authorizations, approvals and permits required to be taken, fulfilled or obtained by its Articles of Association, listing rules of the relevant stock exchanges and applicable PRC Laws) required for executing this contract and all other documents to which Party B is a party.
(4) the documents and materials disclosed by Party B to Party A are all complete, true, accurate and valid in every material aspect; and
(5) Party B acknowledges Party A enters into this Contract with Party B in reliance upon the representations and warranties made by Party B under this Section 7.02.
CHAPTER VIII
BOARD OF DIRECTORS
8.1. The Board of Directors shall consist of five (5) Directors with two (2) appointed by Party A and three (3) appointed by Party B. With authorization from the Board of Directors, no Director shall have any personal liability for any act performed in his capacity as Director of the JVC except for such acts that would constitute violations of the published laws of any jurisdiction to which the JVC or the relevant Director (as the case may be) is subject or the Articles of Association of the JVC.
8.2. If a seat on the Board is vacated by the retirement, resignation, illness, disability or death of a Director or by removal of such Director by the Party which originally appointed him, the Party which originally appointed such Director shall appoint a successor within thirty (30) days from the date of vacancy and notify the other Party and the JVC in writing; otherwise, it shall be deemed to have waived its rights during the period of vacancy until a successor is appointed. Such successor shall be appointed to serve out the balance of the term of office of such Director.
8.3. There is a Chairman and a Vice-Chairman in the Board of Directors. The Chairman shall be appointed by Party A, and the Vice-Chairman shall be appointed by Party B. The term of office for a Director shall be three (3) years and may serve consecutive terms if reappointed by the Party that originally appointed him/her. Upon the expiry of term of a Director, if the Party that appointed such Director fails to send a notification to the JVC requiring the replacement of the Director, the Director shall be deemed to have been reappointed by such Party. Each Director is entitled to cast only one vote.
8.4. The JVC shall convene its first Board meeting within five (5) working days after its incorporation to establish the operation and management organization of the JVC, and to appoint the General Manager to take charge of the JVCs daily operation. The establishment of the organizational structure of the JVC, its operation, management, financial matters, accounting, audit, human resources management as well as the labour union, shall be implemented in accordance with the Articles of Association of the JVC.
8.5. The Board of Directors is the highest authority of the JVC, which discusses and determines the major matters of the JVC. Meetings of the Board shall be
held at least once each year at the registered address of the JVC or other places in China or foreign countries designated by the Board of Directors. The Chairman of the Board shall set an agenda after consultation with the Vice-Chairman of the Board and be responsible for convening and presiding over such meetings. The Board of Directors shall deliver a notification to each Director within ten (10) days prior to the meeting of the board setting forth the agenda, date and location of the meeting. The Vice-Chairman shall convene and preside over the Board meetings if the Chairman is unable or fails to perform his/her functions and duties.
8.6. A Supervisor or one-third (1/3) or more of the Directors of the JVC shall have the right to require the Board of Directors to convene an interim meeting to discuss matters specified by them.
8.7. In case a Director is unable to attend a Board meeting, he/she may issue a proxy and entrust another person to act as his representative to attend the meeting on his/her behalf. The representative so entrusted shall have the same rights and powers as the Director. Should a Director fail to attend or to entrust another to attend, he/she will be deemed as having waived such right.
8.8. A quorum for a Board meeting (including regular meeting and interim meeting) shall require the presence, in person or by proxy, of at least three (3) Directors which must include at least one Director appointed by each Party) (the Quorum). The Board of Directors shall not adopt any resolution at a Board meeting where a Quorum is not present. If, at any Board meeting for which the board meeting notice is properly sent, the Quorum is not present, such meeting shall automatically stand adjourned to the same time and place thirty (30) days after the date for the original meeting. If any Director appointed by any Party still fails to attend the adjourned meeting in person or by proxy, the presence of any three Directors shall be deemed to constitute a Quorum, and such meeting shall be deemed to have been duly convened and any resolution adopted at such Board meeting shall have full legal effect.
8.9. Each Party shall procure that the Directors appointed by such Party attend in person or by proxy, each of the duly convened Board meetings.
8.10. The Directors owe fiduciary duties and duties of care to the JVC and, except as otherwise agreed by both Parties, may not engage in any activities that compete with, or may jeopardize any interests of the JVC.
8.11. All of the major matters of the JVC shall be determined by the Board of Directors, including but not limited to:
(1) amendment of the Joint Venture Contract and/or the Articles of Association of the JVC;
(2) the merger of the JVC with any other economic organization, and the split-off of the JVC;
(3) termination or dissolution of the JVC;
(4) the increase, decrease or transfer of the JVCs registered capital;
(5) important development strategies, operational plans and external investments by the JVC in the future, except for matters specified in item (3) of Section 10.2 hereof;
(6) any material financing by the JVC that exceeds [**], or any financing arranged after the debt to asset ratio of the JVC exceeds 80%;
(7) purchase, disposal or discarding by the JVC of fixed assets or real estate with a value exceeding [**];
(8) any guarantee offered by the JVC to a third party;
(9) investment by the JVC in any derivative financial instruments (stock, security or futures);
(10) any material affiliated transaction outside of the daily operations of the JVC in which the amount involved exceeds [**] (For the purpose of this Contract, an affiliated transaction shall be governed by the relevant provisions in Accounting Standards for Enterprises No. 36 Disclosure by Affiliated Parties);
(11) execution of a material contract with a term of over five years outside of the ordinary business of the JVC;
(12) engagement by the JVC of an auditor to audit the annual financial statements; and
(13) appointment of the liquidation committee of the JVC;
Resolutions involving aforesaid material matters shall be adopted by the unanimous affirmative vote of all Directors attending a meeting of the Board. Other resolutions shall be adopted by the affirmative vote of a simple majority of Directors.
8.12. Resolutions involving the matters set forth in Section 8.11 (the Relevant Matters) shall be adopted by the unanimous vote of all Directors present in person or by proxy at a duly convened Board meeting. In case a deadlock occurs when a board resolution in respect of the Relevant Matters fails to
receive the required minimum number of affirmative votes , the Parties shall conduct friendly consultation regarding the Relevant Matters, and re-convene a Board meeting to re-deliberate the Relevant Matters within thirty (30) days. If no resolution regarding the Relevant Matters is adopted, senior management members of both Parties shall negotiate to settle the matters.
If the senior management members of both Parties fail to reach consensus regarding the Relevant Matters within thirty (30) days, any Party (the Seller) shall have the right to require the other Party (the Buyer) to purchase all of its equity interest in the JVC. If the Buyer is unwilling to purchase the equity interest held by the Seller in whole, the Buyer must sell all of the equity interest it holds in the JVC to the Seller. If the Seller is unwilling to purchase the equity interest held by the Buyer in whole, or if each Party offers to sell its equity interest to the other Party at the same time, the Parties shall apply with the Approval Authority for approval to early dissolve and liquidate the JVC.
The Parties agree, with respect to the equity transfer under this Section 8.12, the transfer price shall be the appraised value of the relevant equity interest in the JVC as determined by a PRC-registered asset appraisal institute jointly appointed by the Parties. Under any of the above circumstances, the Party which sells its equity interest must endeavour to execute all documents necessary for the sale of the equity interest in order to effectuate and perform the sale of equity interest under this Section.
8.13. The Board of Directors may adopt a resolution by signing the written resolution or the Board may hold a meeting via teleconference or other methods such that the participants can communicate. A Board meeting so convened is a valid Board meeting, and the relevant Board resolutions should be signed by each Director. The Directors may either jointly sign one copy of the resolutions or separately sign two or more copies thereof; in each case, such resolutions are valid resolutions. Except for resolutions involving the matters set forth in Section 8.11, which may only be adopted by the unanimous vote of all Directors of the Board, written resolutions signed by at least three Directors constitute valid resolutions. The resolutions adopted without meetings will also be kept by a person designated by the Board of Directors.
8.14. Except as otherwise specified in the Articles of Association of the JVC, Directors shall perform their duties without any remuneration in general. However, Directors shall receive reimbursement for all out-of-pocket expenses incurred in attending meetings of the Board and may receive remuneration and reimbursement in relation to special tasks assigned to them by the Board under a budget approved by the Board.
8.15. Functions and Duties of the Chairman
(1) The Chairman will perform the following functions and duties in his/her capacity as the legal representative of the JVC:
(i) to convene and presides over the Board meeting;
(ii) to check the implementation status of the Board resolutions and report such status to the Board of Directors;
(iii) subject to the Board resolutions and decisions, to provide support to major business activities of the JVC; and
(iv) to sign important documents of the JVC in accordance with the authorizations granted by the Board of Directors.
(2) The Vice-Chairman shall assist the Chairman with his/her work and may perform the functions and duties of the Chairman if the Chairman is unable to perform his/her functions and duties due to temporary absence, illness or lack of capacity, or if the Chairman fails to perform his/her functions.
The Chairman, the Vice-Chairman and the Directors shall perform their functions and duties within the scope of authorization granted by the Board of Directors. Without obtaining prior written authorization and consent of the Board of Directors, the Chairman, the Vice-Chairman or the Directors may not represent the JVC to execute any contract, agreement or other legal document.
8.16. Each Board meeting shall have detailed minutes with signatures of the Directors/representatives thereof as well as the minute takers. The Directors shall have the right to have their speeches at the Board meetings fully and accurately recorded in the minutes. The minutes shall be prepared in Chinese and kept on file by the JVC.
CHAPTER IX
SUPERVISORS
9.1. The JVC shall have two Supervisors, and each Party shall appoint one Supervisor. The Supervisors shall have a term of three (3) years and may serve consecutive terms. Each Party may decide to replace the Supervisor appointed by such Party at any time. Upon the expiry of term of a Supervisor, if the Party who appointed such Supervisor fails to send a notification to the
JVC requiring the removal of the Supervisor, the Supervisor shall be deemed to have been reappointed by such Party.
9.2. The Supervisors will perform the following functions and duties:
(1) to examine the JVCs financial affairs;
(2) to monitor the acts of the Directors and senior personnel when carrying out their duties in relation to the JVC, and to make proposals to remove from their positions any Directors or any senior personnel who violate PRC Laws or the Articles of Association of the JVC;
(3) to require the Directors or senior personnel to rectify their conduct when any of their actions damage the interests of the JVC;
(4) to propose to convene interim Board meetings;
(5) to put forward proposals at Board meetings;
(6) to bring lawsuits against Directors or senior personnel in accordance with Section 152 of the Company Law; and
(7) other functions and duties that should be performed by the Supervisors.
9.3. The Supervisors may attend and observe Board meetings, and make inquiries or give advice in respect of matters set forth in Board resolutions. Any of the Supervisors may investigate into abnormalities that he/she finds in the JVCs operation, and may engage advisers such as an accounting firm to assist with the investigation as and when needed, the cost of which shall be assumed by the Party who appoints such Supervisor.
9.4. The Party who appoints the Supervisor shall be responsible for all expenses necessary for such Supervisor to exercise his/her functions and duties.
CHAPTER X
MANAGEMENT ORGANIZATION
10.1. The JVC shall implement a system whereby the General Manager assumes responsibility under the leadership of the Board of Directors. The operation and management organization shall have one General Manager, one Managing Deputy General Manage and one CFO. The General Manager shall be responsible for the daily operation and management of the JVC. The Parties agree that the General Manager and the CFO of the JVC shall be nominated by Party B and appointed by the Board of Directors; the Managing Deputy
General Manage shall be nominated by Party A and appointed by the Board of Directors. The General Manager, the Managing Deputy General Manage and the CFO shall have the terms of three years and may serve consecutive terms upon approval by the Board. The General Manager is entitled to appoint other senior management personnel and determine compensation and benefits for these positions. The General Manager is the legal representative of the JVC. Directors may serve as senior management personnel.
10.2. The General Manager shall perform the following functions and duties:
(1) to organize and carry out resolutions of the Board of Directors, and report work to the Board of Directors;
(2) to take charge of the day-to-day operation, business and financial management of the JVC in all aspects;
(3) to draft development plans, annual budgets, annual fixed assets purchase plans, annual production and operational plans and profit distribution plans of the JVC, and submit such plans to the Board of Directors for approval;
(4) to draw up plans for setting up internal management organizations of the JVC;
(5) to draw up basic management policies of the JVC;
(6) to draw up the Articles of Association of the JVC;
(7) appointment, reward and punishment, and dismissal of management personnel or working personnel except those who should be appointed or dismissed by the Board of Directors;
(8) to deal with important external business matters on behalf of the JVC;
(9) other functions and duties as authorized by the Board of Directors.
10.3. Unless otherwise approved by the Board of Directors, when performing his/her functions and duties, the General Manager may not change Board resolutions or exceed the scope of authorization, mortgage or pledge the JVCs assets without approval, or engage in any form of hedging in the futures market. The General Manager shall submit a monthly operation and financial report to the Chairman of the Board of Directors. Such report shall be submitted within thirty (30) days following the close of month reported.
10.4. The Parties agree that the operation and management, business development, financial plans and the implementation plan for each particular work of the JVC should be implemented by the General Manager pursuant to the plans approved by the Board of Directors.
10.5. If the General Manager is unable to perform his/her functions and duties for a long time due to lack of capacity or other reasons, in order to maintain normal operation of the JVC, the Board of Directors must convene a special meeting within ten (10) days to appoint the candidate nominated by Party B as the new General Manager. The functions and rights of the General Manager shall be assumed by the CFO before the appointment of a new General Manager.
10.6. The General Manager reports to the Board of Directors. The General Manager and other senior management personnel may not engage in any activities that compete with, or jeopardizes any interests of the JVC.
10.7. The Board of Directors may decide to remove and replace the General Manager, the Managing Deputy General Manage or the CFO who has has committed a corrupt act or gross dereliction of duty with a person nominated by the Party which originally appointed the General Manager, the Managing Deputy General Manage or the CFO.
10.8. The Parties undertake that, after incorporation of the JVC, all affiliated transactions between the JVC and Party A or Party B or any of their Affiliates shall comply with the arms length principle, and may not jeopardize the interests of the JVC and/or any of the Shareholders by imposing unfair transaction conditions. Otherwise, the liable party shall compensate the JVC or any shareholder for the actual losses incurred or suffered by them (provided that there is substantial evidence that the interests of the JVC and/or any Shareholder have been damaged).
CHAPTER XI
PURCHASE OF EQUIPMENT AND MATERIAL
11.1. Save as those that require unanimous approval by all Directors, the management team shall make decisions on the procurement of the equipment, raw materials, testing equipment, fuels, accessories and parts, transportation facilities, office supplies etc. that are required for the operation of the JVC.
CHAPTER XII
DISTRIBUTION AND PRODUCT PROCESSING BUSINESS
12.1. Both Parties agree that the JVC shall have the right to continue its existing operation and business model. If, in the future, it is necessary for the JVC to sell the drugs it is permitted to operate through Party A or its Subsidiaries designated by Party A (collectively, the Party A Distributors), the JVC shall give the priority to providing, at reasonable market price, the drugs to Party A Distributors, and then Party A Distributers will, through its distribution networks, distribute such drugs to customers (including other drug distributors, hospitals, dispensaries, clinics and consumers etc.), provided that the distribution terms and conditions offered to the JVC by the Party A Distributors are the same as would be obtained by the JV from other drug distributors. The JVC shall enter into distributorship agreements with the Party A Distributors with respect to the sale of drugs through the networks of the Party A Distributors, the terms and conditions of which shall be determined in accordance with the commercial practices of the industry and on arms length basis. The Party A Distributors shall make timely payment of the drug price to the JVC, and prioritize the drug distribution orders which they have received from the JVC to ensure the drugs of the JVC would be delivered to the relevant customers in a timely, accurate and proper manner. The JVC shall timely assess the services provided by the Party A Distributors, and continue the operation on the condition that the drug distribution services delivered by the Party A Distributors remain competitive in the market. Specific requirements shall be finalized in the distributorship agreement. The terms distribute or distribution mentioned in this Section shall mean that the drug distributors sell and deliver the drugs they are permitted to operate to other drug distributors, hospitals, dispensaries, clinics and consumers etc.
12.2. If it is necessary for the JVC to process or manufacture any products in the future, it shall, under the same conditions, give priority to the production enterprises of Party A to carry out the production and further processing. The production enterprises of Party A shall cooperate with the JVC on arms length basis in accordance with the market conditions.
CHAPTER XIII
DISPOSAL OF CREDITS AND DEBTS AND TRANSITIONAL ARRANGEMENTS
13.1. Unless otherwise provided in the Contract, the JVC shall succeed to and assume all of the rights, liabilities and obligations of Shanghai Huyong.
13.2. The Appraisal Report in Appendix A hereto reflects the appraised value of the assets of Shanghai Huyong at the Appraisal Date, and based on which, the Parties have determined the amount of capital that Party B has to contribute to acquire 51% of the equity interest in the JVC. Considering that Shanghai Huyong continues in business as a going concern, and there have been changes in the Shanghai Huyongs operations from the Appraisal Date to the Date of Establishment of the JVC, both Parties agree to jointly engage a PRC-registered accounting firm (the Auditor) within 5 working days from the Date of Establishment to audit the financial report of Shanghai Huyong for the period ended on the Date of Establishment of the JVC. If the Auditor determines the net asset value on the Date of Establishment of the JVC (excluding all the profits generated after January 1, 2013 or June 31, 2013 depending on the Date of the Establishment of the JVC as set out in Section 13.07) is lower than [**], Party A shall promptly pay to the JVC an amount equals to such difference in cash. If the net asset value (excluding all the profits generated after January 1, 2013 or June 31, 2013 depending on the Date of the Establishment of the JVC as set out in Section 13.07) exceeds [**], Party A shall not be required to make any payment to the JVC and the JVC shall not be required to refund the difference to Party A either. The JVC shall prepare its general ledger based on the audited financial statement for the period ended on the Date of Establishment (in the case that Party A is required to pay the difference to the JVC in accordance with the provisions of this Section, the audited financial statements which reflects the payment of the difference shall be used as the basis).
13.3. Both Party A and Party B agree that Party A shall fully indemnify the JVC and/or Party B all the losses incurred to them (including litigation and legal expenses) with respect to all tax liabilities, administrative penalties, indebtedness (including contingent debts except for the debts set forth in Section 13.04 herein (i.e. the additional debts incurred, on fair and reasonable terms, to Shanghai Huyong related to its normal operations in the ordinary course of business after the date hereof)), guarantees, liabilities, obligations, claims, compensation (if any), which are outstanding as of the date hereof or continues after the date hereof and not disclosed in Appendix B hereto, arising from or in consequence of the execution and performance of contracts or engagement of other business activities by Shanghai Huyong, whether the demands or the claims against the JVC and/ or Party B are brought before or after the Date of Establishment of the JVC.
13.4. Party A undertakes that prior to the completion of the delivery as described in Section 13.05 herein, Shanghai Huyong shall carry on its business and enter into contracts, agreements, guarantees or undertakings for fair and reasonable market value in its normal course of business, and shall not take any action or
act in any manner which may be detrimental to the JVC. Party A shall indemnify the JVC and/or Party B from all losses (including but not limited to the liquidated damages or penalties for early termination or rescission of the relevant documents by the JVC unilaterally upon the decision of the Board of Director, which the Board considers detrimental to the interests of the JVC) incurred to the JVC and/ or Party B.
13.5. Party A shall, within 5 working days from the Date of Establishment of the JVC, assist the working group designated by JVC in stocktaking, counting and confirming the inventory of Shanghai Huyong , and deliver to the JVC all the assets and documents of Shanghai Huyong, including but not limited to stamps, licenses and certificates, bills, financial seals, financial statements, accounting information, business information, rules and regulations, employee information (including labour contracts, social security payment information, resume, etc.), contracts and other legal documents, and electronic files thereof. The JVC shall confirm to Party A in writing the receipt of the assets and documents as per above provision. If Party B, in the delivery process, is aware of any circumstance which is materially inconsistent with the representations, warranties or undertakings made by both parties herein (including the appendices), the Parties shall promptly resolve it through negotiations. If no agreement is reached within one month since the commencement of the negotiations, Party B shall have the right to terminate this transaction, this Contract, the Articles of Association and the Capital Increase Agreement. In that case, Party A shall, within 5 working days upon its receipt of the written notice of termination from Party B, execute the necessary documents and jointly with Party B apply to the competent Approval Authority for the termination of this Contract, the Articles of Association and the Capital Increase Agreement, and process the formalities to covert the JVC back to a single-member limited liability company wholly owned by Party A. The JVC shall return Party B all the actual capital contribution made by Party B to the JVC (if any) within 5 working days from the date of the issuance of approval by the competent Approval Authority.
13.6. Party A shall be responsible for handling the legal and economic connections and assume any liabilities of the investment projects (if any) which are not taken up by the JVC so as to ensure under no circumstance, will the JVC be liable for any consequences in connection therewith.
13.7. Party A further agrees and acknowledges a) if the Date of Establishment of the JVC is not later than December 31, 2013, Party A and Party B shall share all profits of Shanghai Huyong/the JVC generated after the Appraisal Date in the proportions 49% to Party A and 51% to Party B; and b) If the Date of Establishment of the JVC is later than December 31, 2013, only Party A shall be entitled to the profits of Shanghai Huyong/ the JVC generated during the
period from the Appraisal Date to June 30, 2013, while all profits of Shanghai Huyong/ the JVC generated after June 30, 2013 shall be shared between Party A and Party B in the proportions 49% to Party A and 51% to Party B.
CHAPTER XIV
LABOUR MANAGEMENT
14.1. Employee policies including the hiring, employment, dismissal, wage system, remuneration, labour insurance, welfare and benefits, penalty and rewards etc. shall be formulated by the General Manager in accordance with the Labour Law of the Peoples Republic of China and other applicable PRC Laws and submitted to the Board of Directors for approval and execution.
14.2. Pursuant to Chapter 13 of the Regulations for the Implementation of the Law of the Peoples Republic of China on Chinese-foreign Equity Joint Ventures, employees of the JVC who are eligible to join trade unions shall have the right to establish a trade union to represent their interests and to develop trade union activities and other activities permitted by the PRC Laws.
14.3. The General Manager, within the powers authorized and delegated by the Board of Directors, shall have the discretion to determine, in accordance with the PRC labor management laws, the conditions of employment of the staff and workers of the JVC, internal rules, procedures and standards for hiring, firing and disciplining employees and arrangements for work and leave, etc.
14.4. The engagement, wages and benefits, social insurance, welfare etc. of the General Manager and the Managing Deputy General Manager of the JVC shall be discussed and decided upon at a Board meeting in accordance with the prevailing local market conditions.
14.5. Party A confirms that Shanghai Huyong has fifty (50) employees or dispatched employees (the Personnel), out of which, a) forty-four (44) have entered into employment contracts Shanghai Huyong; b) one is Party As employee and has been seconded to Shanghai Huyong, hereinafter referred to as the Party A Employee, c) two are dispatched employees dispatched by labor dispatch agencies; and d) three are retired-rehired staff who have employment relationship with Shanghai Huyong. Details of the Personnel of Shanghai Huyong are set forth in Appendix C hereto List of Personnel. Party A represents and warranties that information disclosed in Appendix C hereto is true, accurate and complete.
Party A and Party B agree the Personnel listed in Appendix C (except for the Party A Employee, the Transferred Employees) shall be transferred to and
employed by the JVC on the same compensation term and with the same employment methods (by entry into labor contracts, rehire of the retired employees or dispatch from labor dispatch agencies), and the JVC shall not terminate any of the Transferred Employees within one year from the Date of Establishment of the JVC, except for those who have seriously violated the employee policies of the JVC. However, the JVC may adjust the Transferred Employees position as it deems appropriate in light of its business operations. Prior to the Date of Establishment of the JVC, Party A shall reach settlements with Shanghai Huyongs employees or dispatched employees (if any) and that are not listed in Appendix C hereto and the JVC shall not be held responsible for any legal or economic liabilities arising therefrom.
14.6. Both Parties further acknowledge, agree and warrant that the term of service, welfare, social security expenses, compensations or severance packages with respect to the Transferred Employee shall be implemented pursuant to the Labor Law of the Peoples Republic of China, the Labor Contract Law of the Peoples Republic of China and other applicable PRC Laws.
14.7. Both Parties agree, acknowledge and undertake that, they shall procure, upon the establishment of the JVC, the JVC enters into necessary documents with the Transferred Employees or labor dispatch agencies pursuant to the principals set forth in Sections 14.05 and 14.06 herein to establish the rights and obligations between the JVC and the Transferred Employees or labor dispatch agencies.
Both Parties further agree and acknowledge that a) JVC shall not be held responsible for any liabilities in respect of the individual tax withholding, social insurance and housing fund contribution related to the Transferred Employees occurred prior to the Date of Establishment of the JVC, and Party A shall indemnify the JVC all losses suffered by the JVC in respect thereof arising from administrative sanctions, third party claims or suits; b) Party A shall have liability for the payment of long service benefits, compensation or severance to certain employees of Shanghai Huyong who have left Shanghai Huyong prior to the Date of Establishment and JVC shall take no economic or legal responsibility or obligation in any form therefor; and 3) with respect to the Transferred Employee who are entitled to severance payment calculated based on the their consecutive length of service upon the termination of the employment with the JVC, if Party A fails to disclose their length of services in Appendix C hereto, Party A shall be held responsible for such severance payment.
CHAPTER XV
TAXATION
15.1. The JVC shall pay various taxes in accordance with PRC Laws and shall enjoy all preferential policies and treatments granted by the Central Government and Shanghai Municipal Government.
15.2. The employees of the JVC shall pay their respective income tax as provided under the Individual Income Tax Law of the Peoples Republic of China.
CHAPTER XVI
FINANCIAL AFFAIRS AND ACCOUNTING
16.1. The JVC shall establish an accounting organization, provide itself with accounting personnel and formulate its accounting system in accordance with the Accounting System of the Peoples Republic of China issued by the Ministry of Finance and in the light of its own actual circumstances.
16.2. The JVC shall prepare monthly, quarterly and annual financial statements, including a profit and loss statement, balance sheet, cash flow statement and statement of changes in equity.
The Board of Directors shall engage an internationally recognized PRC qualified public accounting firm as an independent auditor which shall examine and verify the annual financial reports of the JVC in accordance with PRC laws and by reference to internationally used accounting methods.
Such annual financial reports and audit reports shall be delivered to each Director at least ten (10) days before the same are submitted to the Board of Directors for approval.
The Annual financial reports and annual audit reports which have been approved by the Board of Directors shall be delivered to the Parties and the relevant governmental authorities for filing according to PRC Laws.
16.3. Both Parties agree that if either Party provides conclusive evidence proving that the audit reports issued by the internationally recognized accounting firm engaged by the Board of Directors of the JVC pursuant to Section 16.02 above contain significant errors or untrue statements, the Parties shall consult with each other and procure the JVC, in the next fiscal year, to engage another PRC
qualified and internationally recognized public accounting firm registered in the PRC to be the independent auditor to audit the accounts of the JVC and issue audit report accordingly.
16.4. All expenditure documents of the JVC shall be valid only if jointly signed by the General Manager (or a person authorized thereby) and CFO, except as otherwise determined by the Board of Directors of the JVC. The JVC shall use the invoices issued by the tax authority as evidence of receipt and payment. The invoices issued for the oversea (including Hong Kong and Macao) purchase of merchandise such as machinery, equipment, parts and components (where the custom declaration is required) will be deemed valid only if supported by declaration forms with the PRC ports of entry or custom declaration forms with the PRC customs.
16.5. The JVC shall adopt the internationally used accrual basis of accounting and the debit and credit method of keeping accounts in its accounting. All vouchers, books, receipts, statements and other accounting documents shall be printed in Chinese. The JVC shall use Renminbi as its standard bookkeeping currency. Save as those accounted for in standard bookkeeping currency, the foreign accounts including cash, bank deposits, other currency payments, as well as credits and debts, revenue and expenses etc. relation to transactions dominated in foreign currencies shall be accounted for and expressed in foreign currencies and converted into Renminb in the preparation of the financial statements report. The exchange difference resulted from the conversion shall be accounted for as exchange gains and losses. The changes in exchange rate and the balance of each foreign currency accounts shall be handled pursuant to the applicable PRC Laws and the provisions under the financial accounting system.
16.6. Except for the first year of the establishment of the JVC, the fiscal year of the JVC shall run from January 1 to December 31 of the Gregorian calendar year.
16.7. The net profits of the JVC shall be subject to the applicable corporate accounting standards.
16.8. After the offset of cumulative losses, Three Funds shall be set aside out of the JVCs net profits and the specific amounts and the percentages for the various funds shall be decided upon by the Board of Directors. In the event of the liquidation of the JVC, any unused portion of the reserve fund and expansion fund shall be treated as part of the assets of the JVC.
16.9. Both Parties agree that the JVC shall adopt a dividend distribution policy allowing to distribute dividends to the maximum extent possible, which means, after the offset of cumulative losses (if any) for previous years , JVC shall distribute at least 50% of its distributable profits to the shareholders in
proportion to their perspective ownership percentage. The dividend payout ratio and time of making such distribution shall be determined by the Board of Directors of the JVC based on the prevailing operating status of the JVC.
CHAPTER XVII
FOREIGN EXCHANGE CONTROL
17.1. All matters in relation to foreign exchange control of the JVC shall be dealt in accordance with the Regulations on Foreign Exchange Control of the Peoples Republic of China.
17.2. The JVC may open Renminbi accounts and foreign currency accounts within or outside China pursuant to the applicable laws and regulations.
17.3. The JVC shall be responsible for balancing its foreign exchange revenues and expenditures.
CHAPTER XVIII
EFFECTIVE DATE, TERM AND TERMINATION
18.1. This Contract shall come into effect on the Effective Date.
18.2. The operating period of the JVC shall be fifty (50) years, commencing from the Date of Establishment of the JVC. Upon expiry of the Joint Venture Term, the Parties may consult to each other and decide to apply for extension of the Joint Venture Term. If the Investing Parties unanimously agree to extend the Joint Venture Term, and after a resolution to that effect is adopted at a Board meeting, a written application shall be submitted to the Examination and Approval Authority six (6) months prior to expiry of the Joint Venture Term. The term shall be extended only upon approval of such application. The procedures for amendment of registration shall be carried out with the registration authority.
18.3. If both Investing Parties consider it to be in their best interests to terminate the JVC, they may terminate the JVC early. In case of such early termination, a resolution to that effect shall be adopted by unanimous approval of all Directors in attendance at a Board meeting and such early termination shall be reported to the Approval Authority for approval.
18.4. Either Party shall may terminate the Contract prior to expiry by giving written notice to the other party, if any of following circumstances occurs:
(1) the other party becomes bankrupt, shutdown or is liquidated;
(2) the other Party has materially breached the terms of this Contract and failed to cure such breach and/ or take the liability for breach within sixty (60) days from the receipt of the written notice from the non breaching Party, requiring it to ratify such breach;
(3) the other Party attempts or takes any step to transfer its equity held in the JVC in violation of any of the provisions set forth in this Contract;
(4) all or substantial part of the JVCs assets have long been requisitioned by any governmental authority for a long period of time;
(5) any competent governmental authority requires any Party to revise any provisions of this Contract or impose any conditions or restrictions on the implementation of this Contract, causing material adverse consequences to the JVC or any Parties benefits;
(6) the JVC is unable to continue its business operations due to its inability to make up the accumulated losses or the occurrence of irreparable serious damages to its assets; and
(7) the JVC is rendered unable to continue its normal operation by an event or its consequence of Force Majeure as defined in Section 22.1 herein which continues in existence for over one hundred and eighty (180) days.
T he Articles of Association and the Capital Increase Agreement shall be terminated upon the early termination of this Contract. However, the early termination of the above documents shall not prejudice the right of the non-breaching Party to hold the breaching Party responsible for its breaches.
18.5. If either Party issues a notice for the purpose of terminating this Contract, the Parties shall negotiate and endeavor to eliminate the cause for termination within two (2) months from the date of the issuance of such notice. If, by the end of such two-month period, both Parties fail to agree on the solution to such issues, the JVC shall submit an application to the Approval Authority for early termination (unless the acquisition of equity interest occurs in accordance with provisions of Section 18.06 below).
18.6. If the Joint Venture Term is not extended pursuant to Section 18.2 or the Parties fail to reach a negotiated solution after either Party has delivered a notice of early termination pursuant to Section 18.5, the JVC shall continue its
operation only if a Party (the Purchaser) notifies the other Party (the Seller) of its intention to acquire the equity of the JVC held by the Seller (the Acquisition Notice), and the acquisition of such interests shall be proceeded on the following terms and conditions:
18.7.
(1) the Parties shall negotiate the purchase price to their satisfaction. If Party A and Party B fail to reach a mutually acceptable purchase price within one (1) days from the date of its receipt of the Acquisition Notice, the purchase price shall be determined pursuant to Section (2) below;
(2) the Parties shall, within two (2) months from the date of the issuance of the Acquisition Notice, jointly engage an asset appraisal firm registered in the PRC to conduct a valuation on the JVC. The valuation shall be completed within one (1) month subsequent to the above engagement and shall be determined based on the assumption that the JVC continues in business as a going concern. The purchase price shall be equal to the product of a) value of the JVC as determined based on the joint valuation multiplied by b)the percentage of registered capital held by the Seller at that time;
(3) Unless otherwise agreed in writing by both Parties, the Purchaser shall, within seven (7) days from the effectiveness date of the relevant equity transfer agreement, pay eighty percent (80%) of the purchase price determined pursuant to Sections (1) or (2) above to the Seller, and pay the balance of twenty percent (20%) of the purchase price within seven (7) days after the transfer formalities have been duly and legally completed.
18.8. Prior to any liquidation of the JVC, both Investing Parties shall continue the performance of their obligations and exercise of their rights, and ensure the ordinary operation of the JVC.
CHAPTER XIX
LIQUIDATION AND DISPOSAL OF THE ASSETS OF THE JOINT VENTURE COMPANY
19.1. In the event of the early termination of the Contract or upon expiry of the Joint Venture Term, the Board of Directors shall appoint a liquidation committee which has the authority to represent the JVC in all legal matters and shall
value and liquidate the JVCs assets in accordance with the applicable PRC Laws and regulations and the principles set out herein.
19.2. The Liquidation committee shall be made up of five (5) members, of which two (2) members shall be appointed by Party A and three (3) members shall be appointed by Party B. Members of the liquidation committee may, but need not, be the Directors of the JVC. Subject to the consent of the Board of the Directors, the liquidation committee may also appoint professional advisors, such as accountants and lawyers qualified in the PRC, to assist the liquidation committee.
19.3. The liquidation committee shall conduct a thorough examination of the JVCs assets and liabilities, on the basis of which it shall develop a liquidation plan which, if approved by the Board of Directors, shall be executed under the liquidation committees supervision.
19.4. In developing and executing the liquidation plan, the liquidation committee shall use every effort to obtain the highest possible price in foreign currency for the JVCs assets and business. To the extent permitted under the PRC Laws, consideration shall be given to sale of the JVCs assets or business by public auction or by tender open to domestic and foreign bidders with a view towards obtaining prices at international market rates. If necessary, Renminbi shall be converted to foreign exchange in accordance with the relevant PRC Laws. Any cost in relation to the conversion of Renminbi into foreign currency shall be deemed as liquidation expenses.
19.5. The liquidation expenses, including remuneration to members and advisors of the liquidation committee, shall be paid out of the JVCs assets in priority to the claims of other creditors.
19.6. After the liquidation of the JVC, the balance of its assets shall be distributed between the Parties in proportion to their respective contribution to the registered capital of the JVC.
19.7. On completion of all liquidation procedures, the liquidation committee shall submit a final report approved by the Board to the Examination and Approval Authority, and hand in the JVCs Business License to the original registration authority and complete all other formalities for nullifying the JVCs registration. Party B shall have the right to obtain copies of all of the JVCs accounting books and other documents but the originals thereto shall be left in the care of Party A.
CHAPTER XX
INSURANCE
20.1. All items of insurance of the JVC shall be taken out by the JVC from the insurance company which it considers most suitable as permitted by Chinese law. The risks insured, insured values, coverage periods, etc., shall be discussed and decided upon at meetings of the JVCs Board of Directors in accordance with the regulations of the insurance company.
CHAPTER XXI
AMENDMENT OF THE CONTRACT
21.1. This Contract (including its appendices) may be amended only by written agreement executed by the Investing Parties. Amendments involving matters which require governmental approvals shall come into effect upon the approvals of the Approval Authority.
CHAPTER XXII
FORCE MAJEURE
22.1. Force Majeure referred herein shall mean the occurrence of any event or circumstance after the date hereof that is non-foreseeable (or inevitable or beyond control even has been foreseen), inevitable or not capable of being overcome and such event prevents, hinders or substantially affects any Partys performance of all or part of its obligation of this Contract. Force Majeure includes, but not limited to, earthquakes, typhoons, floods, fires, strikes, wars, terrorist attacks or riots, etc.
22.2. Unless otherwise provided herein, if a Force Majeure event occurs after the execution of this Contract, and the Party affected (the Affected Party) is unable to perform or unable to fully, promptly and appropriately perform any of its obligations hereunder, the performance of the relevant obligations by the Affected Party shall be suspended during the delayed period which the Force Majeure event occurs, and the performance period shall automatically be extended for the same period of the time as the suspension period. The Affected Party shall not be liable for breach of contract. However, the Affected Party shall, via facsimile or express delivery, provide details of the Force Majeure event to the other Party within 7 days after the occurrence of the Force Majeure event or the restoration of the communication conditions, stating in details the reason why the Affected Party was unable to fully, promptly and appropriately perform its obligations hereunder, and the relevant documents issued by local authority proving the occurrence of such Force Majeure event and its duration. The Affected Party who fails to provide the
notification and relevant proofs shall not claim a Force Majeure event and will not be exempted from liabilities for breach of contract pursuant to the provisions herein.
22.3. The Affected Party shall promptly take all reasonable and practice measures to eliminate or mitigate the effects of any Force Majeure event, and shall promptly resume the performance of its obligations as soon as the Force Majeure event is eliminated or mitigated. The Affected Party who fails perform the aforesaid obligations shall assume the liability for breach of contract with respect to the extended losses arising therefrom or liability for failure to resume the performance of the obligations hereunder as soon as the effects of the Force Majeure event are eliminated or mitigated.
CHAPTER XXIII
SETTLEMENT OF DISPUTES AND GOVERNING LAW
23.1. Any dispute arising from this Contract shall be settled through friendly consultations between both Parties. If a dispute cannot be settled within sixty (60) days after the commencement of consultations, then a Party to the dispute may submit it to the Shanghai International Economic and Trade Arbitration Commission for arbitration in accordance with its arbitration procedures. Such arbitration shall be final and binding on both Parties.
23.2. During the period of arbitration of a dispute, the Investing Parties shall continue to perform their obligations hereunder, except for those obligations involved in the matter under dispute, and to exercise their rights hereunder.
23.3. The execution, validity, interpretation and performance of this Contract and the settlement of disputes related to this Contract shall all be protected and governed by PRC Laws.
CHAPTER XXIV
CONFIDENTIALITY
24.1. Both Parties hereby agree that they shall not disclose to any third party (other than any legal or accounting advisor or other advisors engaged by both Parties for the purpose of performing the transactions hereunder) any part of this Contract (including its Appendices), or any other agreements that either Party may be negotiating, or details of confidential negotiations for the abovementioned agreements, or any business or secrets disclosed by either
Party, except as required by law, the stock exchange, property exchange or regulatory bodies, or for purpose of preforming one Partys obligations under the abovementioned Contract or agreements. When such requirement to disclose has arisen, the disclosing Party shall obtain the other Partys written consent prior to the disclosure, which consent shall not unreasonable delayed.
24.2. The Parties shall cause their Directors and other Working Personnel, and those of their Subsidiaries or Affiliates, also to comply with the confidentiality obligation set forth in Section 23.01 above.
24.3. The obligations under Sections 23.01 and 23.02 above shall survive the termination of this Contract and the termination and dissolution or liquidation of the JVC howsoever caused.
CHAPTER XXV
BREACH OF CONTRACT
25.1. If a Party fails to perform any of its obligations under this Contract or if a Partys representation or warranty under this Contract is untrue or materially inaccurate, such Party shall be deemed to have breached this Contract. Unless otherwise provided herein, the Party in breach shall have sixty (60) days from the receipt of notice from the non-breaching Party specifying the breach to correct such breach if remediable. If a curable breach is not cured within sixty (60) days, the breaching Party shall indemnify the other party against any losses arising from such breach. If a breach is not curable, the breaching Party shall immediately indemnify the other party against any losses arising from such breach.
CHAPTER XXVI
GENERAL PROVISIONS
26.1. The invalidity of any provision of this Contract (including Appendices) shall not affect the validity of any other provision of this Contract.
26.2. This Contract is written in Chinese and executed in four counterparts. Each Party holds one copy and the other two copies are used for the processing of the approval and registration formalities with the government. Each copy shall have the same legal effect.
26.3. This Contract and its Appendices attached hereto constitute the entire agreement between the Parties with respect to the subject matter of this
Contract and supersede all prior discussions, negotiations and agreements between them .
26.4. Any notice or written communication provided under Contract by one Party to another, including but not limited to any and all offers, writings, or notices to be given hereunder, shall be made in Chinese and promptly sent or delivered by one Party to another Party by facsimile or express mail. With respect to the communications and notices given pursuant to the provisions herein, it shall be deemed to have properly served on the Party on the first (1) working day by facsimile (provided that the sender has received a report indicating the message is successfully sent) or on the second (2) working day from the date after being sent by express mail. All the notices and communications shall be sent to the below addresses or facsimile numbers, until the same is changed by notice given in writing to the other Party:
Party A: Sinopharm Group Co., Ltd. [ 国药控股股份有限公司 ]
Address: 6F, 221 Fuzhou Road, Huangpu District, Shanghai, China
Attention: General Manager
Facsimile: (86-21) 2305-2241
Party B: Hutchison Chinese Medicine GSP (HK) Holdings Limited [ 和黄中国医药分销 ( 香港 ) 控股有限公司 ]
Address: Suit 2018, 21F, Hutchison House, 10 Harcourt Road, Central, Hong Kong
Attention: Director
Facsimile: (852) 2121-8281
CHAPTER XXVII
APPENDICES
27.1. The appendices of this Contract include:
(A) Appraisal Report of Enterprise Value;
(B) Confirmation of Shanghai Huyongs Existing Contracts and Outstanding Debts; and
(C) List of Personnel.
IN WITNESS WHEREOF, this Contract is signed as of the date stated at the top of the first page by the duly authorized representatives of the Investing Parties.
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Party A: |
Sinopharm Group Co., Ltd. [ 国药控股股份有限公司 ] |
Legal Representative: |
/s/ WEI Yulin |
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[Signature : WEI Yulin and company seal] |
Party B: |
Hutchison Chinese Medicine GSP (HK) Holdings Limited [ 和黄中国医药分销 ( 香港 ) 控股有限公司 ] |
Authorized Representative: |
/s/ Christian Lawrence Hogg |
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[Signature : Christian Lawrence Hogg and company seal] |
CERTIFICATION
I, Christian Hogg, certify that:
1. I have reviewed this Amendment No. 2 to the annual report (the Report ) on Form 20-F of Hutchison China MediTech Limited (the Company ); and
2. Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report.
Date: May 30, 2019
By: |
/s/ Christian Hogg |
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Name: |
Christian Hogg |
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Title: |
Chief Executive Officer |
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CERTIFICATION
I, Johnny Cheng, certify that:
1. I have reviewed this Amendment No. 2 to the annual report (the Report ) on Form 20-F of Hutchison China MediTech Limited (the Company ); and
2. Based on my knowledge, this Report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this Report.
Date: May 30, 2019
By: |
/s/ Johnny Cheng |
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Name: |
Johnny Cheng |
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Title: |
Chief Financial Officer |
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