UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K/A
(Amendment No. 2)
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 11, 2015
Foundation Medicine, Inc.
(Exact name of registrant as specified in its charter)
Delaware | 001-36086 | 27-1316416 | ||
(State or other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
150 Second Street
Cambridge, MA 02141
(Address of Principal Executive Offices) (Zip Code)
(617) 418-2220
(Registrants telephone number, including area code)
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
EXPLANATORY NOTE
This Amendment No. 2 (this Amendment) to the Form 8-K of Foundation Medicine, Inc. (the Company), originally filed on January 12, 2015 and amended on February 2, 2015 (the Form 8-K), is being filed solely to re-file Exhibits 10.2, 10.3 and 10.4 to the Form 8-K in response to comments from the Securities and Exchange Commission (the SEC) regarding a confidential treatment request submitted to the SEC with respect to Exhibits 10.2 and 10.4 of Item 9.01 of the Original Report, which is hereby amended to include a revised redacted version of Exhibits 10.2, 10.3 and 10.4.
No other changes have been made to the Form 8-K. This Amendment speaks as of the original filing date of the Form 8-K and does not reflect any events that occurred at a date subsequent to the filing of the Form 8-K or modify or update those disclosures therein in anyway way. Accordingly, this Amendment No. 2 should be read in conjunction with the Companys filings made with the SEC subsequent to the filing of the Form 8-K.
Item 1.01. Entry into a Material Definitive Agreement.
The Collaboration Agreement, the Ex-US Commercialization Agreement, the US Education Collaboration Agreement, and the IVD Term Sheet are incorporated by reference into Item 1.01 of the Form 8-K.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
2.1 | Transaction Agreement, by and between the Company and Roche Holdings, Inc., dated January 11, 2015 (incorporated by reference to Exhibit 2.1 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
4.1 | Investor Rights Agreement, by and between the Company and Roche Holdings, Inc., dated January 11, 2015 (incorporated by reference to Exhibit 4.1 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
4.2 | Amendment to Second Amended and Restated Investors Rights Agreement, by and between the Company and the Investors named therein, dated January 11, 2015 (incorporated by reference to Exhibit 4.2 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
10.1 | Tax Sharing Agreement, by and between the Company and Roche Holdings, Inc., dated January 11, 2015 (incorporated by reference to Exhibit 10.1 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
10.2* | Collaboration Agreement, by and among the Company, F. Hoffman-La Roche Ltd and Hoffman-La Roche Inc., dated January 11, 2015. | |
10.3* | Ex-US Commercialization Agreement, by and between the Company and F. Hoffmann-La Roche Ltd, dated January 11, 2015. | |
10.4* | US Education Collaboration Agreement, by and between the Company and Genentech, Inc., dated January 11, 2015. | |
10.5* | Binding Term Sheet for an In Vitro Diagnostics Collaboration, by and between the Company and F. Hoffman-La Roche Ltd, dated January 11, 2015. | |
99.1 | Form of Tender and Support Agreement entered into by Roche Holdings, Inc. with Third Rock Ventures, L.P., dated January 11, 2015 (incorporated by reference to Exhibit 99.1 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
99.2 | Form of Tender and Support Agreement entered into by Roche Holdings, Inc. with affiliates of KPCB Holdings, Inc., dated January 11, 2015 (incorporated by reference to Exhibit 99.2 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
99.3 | Form of Tender and Support Agreement entered into by Roche Holdings, Inc. with Google Ventures 2011, L.P., dated January 11, 2015 (incorporated by reference to Exhibit 99.3 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). | |
99.4 | Press Release, issued by the Company, dated January 12, 2015 furnished as Exhibit 99.4 of the Companys Current Report on Form 8-K, filed with the SEC on January 12, 2015). |
* | Certain confidential information contained in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***] . This exhibit has been filed separately with the SEC without the redaction pursuant to a Confidential Treatment Request under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Foundation Medicine, Inc. | ||||||
Dated: August 21, 2015 | By: |
/s/ Robert W. Hesslein |
||||
Name: | Robert W. Hesslein | |||||
Title: | Senior Vice President, General Counsel and Secretary |
Exhibit 10.2
EXECUTION COPY
***Text Omitted and Filed Separately with the Securities and Exchange Commission
Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Collaboration Agreement
This Agreement is entered into with effect as of the Effective Date (as defined below)
by and between
F. Hoffmann-La Roche Ltd
with an office and place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland ( Roche Basel )
and
Hoffmann-La Roche Inc.
with an office and place of business at 150 Clove Road, Suite 8, Little Falls, New Jersey 07424, U.S.A. ( Roche US ; Roche Basel and Roche US together referred to as Roche )
on the one hand
and
Foundation Medicine, Inc.
with an office and place of business at 150 Second Street, Cambridge, Massachusetts 02141 (FMI )
on the other hand.
Table of Contents
1. |
Definitions |
7 | ||||||
1.1 |
Affiliate |
7 | ||||||
1.2 |
Agreement |
7 | ||||||
1.3 |
Agreement Term |
7 | ||||||
1.4 |
ALK ctDNA CTA |
7 | ||||||
1.5 |
Applicable Law |
7 | ||||||
1.6 |
Approved Assay |
7 | ||||||
1.7 |
Background IP |
7 | ||||||
1.8 |
Business Day |
8 | ||||||
1.9 |
Calendar Half |
8 | ||||||
1.10 |
Calendar Quarter |
8 | ||||||
1.11 |
Calendar Year |
8 | ||||||
1.12 |
CDx |
8 | ||||||
1.13 |
CDx Development Program |
8 | ||||||
1.14 |
CLIA |
8 | ||||||
1.15 |
Clinical Study |
9 | ||||||
1.16 |
Commercially Reasonable Efforts |
9 | ||||||
1.17 |
Confidential Information |
9 | ||||||
1.18 |
Control |
9 | ||||||
1.19 |
Cover |
10 | ||||||
1.20 |
ctDNA |
10 | ||||||
1.21 |
ctDNA Assay |
10 | ||||||
1.22 |
ctDNA Platform |
10 | ||||||
1.23 |
ctDNA Platform Development Program |
10 | ||||||
1.24 |
ctDNA Working Group |
10 | ||||||
1.25 |
Data Security Breach |
10 | ||||||
1.26 |
Effective Date |
10 | ||||||
1.27 |
Excepted Activities |
11 | ||||||
1.28 |
Excluded Patent Rights |
11 | ||||||
1.29 |
FDA |
11 | ||||||
1.30 |
FDCA |
11 | ||||||
1.31 |
FMI Background IP Patent Rights |
11 | ||||||
1.32 |
FMI Decisions |
11 | ||||||
1.33 |
FMI Development Costs |
11 | ||||||
1.34 |
FMI Know-How |
11 | ||||||
1.35 |
FMI Foreground Patent Rights |
12 | ||||||
1.36 |
FTE |
12 | ||||||
1.37 |
FTE Rate |
12 | ||||||
1.38 |
Handle |
12 | ||||||
1.39 |
HSR |
12 | ||||||
1.40 |
Immunotherapy Testing Platform Development Program |
12 | ||||||
1.41 |
Immuno-Platform Working Group |
12 | ||||||
1.42 |
Initiation |
12 | ||||||
1.43 |
Insolvency Event |
12 | ||||||
1.44 |
Invention |
13 | ||||||
1.45 |
IUO |
13 | ||||||
1.46 |
JMC |
13 | ||||||
1.47 |
JOC |
13 | ||||||
1.48 |
Joint Know-How |
13 | ||||||
1.49 |
Joint Patent Rights |
13 |
- 2 -
1.50 |
JOT |
13 | ||||||
1.51 |
JRDC |
13 | ||||||
1.52 |
Know-How |
13 | ||||||
1.53 |
Molecular Information Platform Program |
13 | ||||||
1.54 |
Molecular Information Platform Working Group |
14 | ||||||
1.55 |
Party |
14 | ||||||
1.56 |
Patent Rights |
14 | ||||||
1.57 |
Performance Specifications |
14 | ||||||
1.58 |
Personal Data |
14 | ||||||
1.59 |
Phase I Study |
14 | ||||||
1.60 |
Phase II Study |
14 | ||||||
1.61 |
Phase III Study |
14 | ||||||
1.62 |
PMA |
15 | ||||||
1.63 |
Quality Standards |
15 | ||||||
1.64 |
R&D Plan |
15 | ||||||
1.65 |
Regulatory Approval |
15 | ||||||
1.66 |
Regulatory Authority |
15 | ||||||
1.67 |
Roche Background IP Patent Rights |
15 | ||||||
1.68 |
Roche Group |
15 | ||||||
1.69 |
Roche Know-How |
15 | ||||||
1.70 |
Roche Foreground Patent Rights |
15 | ||||||
1.71 |
ROW Territory |
15 | ||||||
1.72 |
RUO |
15 | ||||||
1.73 |
Study Data |
16 | ||||||
1.74 |
Sublicensee |
16 | ||||||
1.75 |
Territory |
16 | ||||||
1.76 |
Third Party |
16 | ||||||
1.77 |
US |
16 | ||||||
1.78 |
US$ |
16 | ||||||
1.79 |
Work Stream |
16 | ||||||
1.80 |
Additional Definitions |
16 | ||||||
2. |
Grant of License |
18 | ||||||
2.1 |
Licenses |
18 | ||||||
2.2 |
Sublicense |
20 | ||||||
2.3 |
Right to Subcontract |
20 | ||||||
3. |
Research and Development Collaboration |
20 | ||||||
3.1 |
Molecular Information Platform Program |
20 | ||||||
3.2 |
Immunotherapy Testing Platform Development Program |
23 | ||||||
3.3 |
ctDNA Platform Development Program |
25 | ||||||
3.4 |
CDx Development Program |
27 | ||||||
3.5 |
Samples, Handling and Disposal |
29 | ||||||
3.6 |
Records; Reports; Audits |
30 | ||||||
4. |
Diligence |
31 | ||||||
5. |
Most Favored Customer |
31 | ||||||
6. |
Governance |
31 | ||||||
6.1 |
Joint Management Committee |
31 | ||||||
6.2 |
JRDC |
33 | ||||||
6.3 |
JOC |
34 | ||||||
6.4 |
Alliance Director |
34 | ||||||
6.5 |
Limitations of Authority |
34 | ||||||
6.6 |
Expenses |
35 | ||||||
6.7 |
Lifetime |
35 |
- 3 -
7. |
Regulatory |
35 | ||||||
8. |
Payment |
35 | ||||||
8.1 |
FTE Funding |
35 | ||||||
8.2 |
Molecular Information Platform Program Fees |
35 | ||||||
8.3 |
Immunotherapy Testing Platform Development Budget and Fees |
36 | ||||||
8.4 |
ctDNA Platform Financial Terms |
37 | ||||||
8.5 |
CDx Development Financial Terms |
38 | ||||||
8.6 |
General Terms |
38 | ||||||
8.7 |
Disclosure of Payments |
39 | ||||||
9. |
Accounting and reporting |
39 | ||||||
9.1 |
Timing of Payments |
39 | ||||||
9.2 |
Late Payment |
39 | ||||||
9.3 |
Method of Payment |
39 | ||||||
10. |
Taxes |
39 | ||||||
11. |
Auditing |
40 | ||||||
11.1 |
Right to Audit |
40 | ||||||
11.2 |
Audit Reports |
41 | ||||||
11.3 |
Over or Underpayment |
41 | ||||||
11.4 |
Duration of Audit Rights |
41 | ||||||
12. |
Intellectual Property |
41 | ||||||
12.1 |
Ownership of Inventions, data and results |
41 | ||||||
12.2 |
German Statute on Employees Inventions |
43 | ||||||
12.3 |
Prosecution and Maintenance of Patent Rights Claiming FMI Inventions |
43 | ||||||
12.4 |
Prosecution and Maintenance of Roche Foreground Patent Rights and Joint Patent Rights |
44 | ||||||
12.5 |
Joint Patent Team |
44 | ||||||
12.6 |
CREATE Act |
44 | ||||||
12.7 |
Infringement |
44 | ||||||
12.8 |
Defense |
46 | ||||||
12.9 |
Common Interest Disclosures |
46 | ||||||
13. |
Representations and Warranties |
47 | ||||||
13.1 |
Mutual Representations and Warranties |
47 | ||||||
13.2 |
Activities |
48 | ||||||
13.3 |
Safety Data |
48 | ||||||
13.4 |
Third Party Patent Rights |
48 | ||||||
13.5 |
Inventors |
48 | ||||||
13.6 |
Grants |
48 | ||||||
13.7 |
Ownership and Validity of Know-How |
48 | ||||||
13.8 |
Data Protection (Privacy) and Security |
48 | ||||||
13.9 |
No Other Representations |
50 | ||||||
14. |
Indemnification |
50 | ||||||
14.1 |
Indemnification by Roche |
50 | ||||||
14.2 |
Indemnification by FMI |
51 | ||||||
14.3 |
Procedure |
51 | ||||||
15. |
Liability |
51 | ||||||
16. |
Obligation Not to Disclose Confidential Information |
51 | ||||||
16.1 |
Non-Use and Non-Disclosure |
51 | ||||||
16.2 |
Permitted Disclosure |
52 | ||||||
16.3 |
Press Releases |
52 | ||||||
16.4 |
Publications |
52 | ||||||
16.5 |
Commercial Considerations |
53 |
- 4 -
17. |
Term and Termination |
53 | ||||||
17.1 |
Commencement and Term |
53 | ||||||
17.2 |
Termination |
53 | ||||||
17.2.1 |
Termination for Breach |
53 | ||||||
17.2.2 |
Insolvency |
53 | ||||||
17.2.3 |
Termination by Roche without Cause |
54 | ||||||
17.2.4 |
Termination by Roche for Frustration of Purpose |
54 | ||||||
17.3 |
Consequences of Termination |
54 | ||||||
17.3.1 |
Termination in General |
54 | ||||||
17.3.2 |
Termination by FMI for Breach by Roche or Roches Insolvency; Termination by Roche Without Cause or for Frustration of Purpose |
54 | ||||||
17.3.3 |
Termination by Roche for Breach by FMI or FMI Insolvency |
56 | ||||||
17.3.4 |
Direct License |
57 | ||||||
17.4 |
Other Obligations |
57 | ||||||
17.5 |
Survival |
57 | ||||||
18. |
Bankruptcy |
57 | ||||||
19. |
Miscellaneous |
58 | ||||||
19.1 |
Governing Law |
58 | ||||||
19.2 |
Disputes |
58 | ||||||
19.3 |
Arbitration |
58 | ||||||
19.4 |
Assignment |
59 | ||||||
19.5 |
Debarment and Exclusion |
59 | ||||||
19.6 |
Independent Contractor |
60 | ||||||
19.7 |
Unenforceable Provisions and Severability |
60 | ||||||
19.8 |
Waiver |
60 | ||||||
19.9 |
Appendices |
60 | ||||||
19.10 |
Entire Understanding |
61 | ||||||
19.11 |
Amendments |
61 | ||||||
19.12 |
Invoices |
61 | ||||||
19.13 |
Notice |
61 |
- 5 -
Collaboration Agreement
WHEREAS, FMI has or is developing platforms for use in genomic testing, including development of a molecular information platform, an immunotherapy testing platform, a circulating tumor DNA platform, and a companion diagnostics platform; and
WHEREAS, Roche has expertise in the research, development, manufacture and commercialization of pharmaceutical and diagnostic products, including development of an immunotherapy platform; and
WHEREAS, Roche and FMI want to collaborate on the development of platforms for use in molecular information, immunotherapy, circulating tumor DNA, companion diagnostics, and in vitro diagnostic tests and kits; and
WHEREAS, Roche Holdings, Inc., an Affiliate of Roche, and FMI are concurrently herewith entering into a Transaction Agreement dated as of the date hereof (as it may be amended from time to time, the Transaction Agreement ) which provides, among other things, for Roche to acquire a majority ownership of FMI upon the terms and subject to the conditions set forth in the Transaction Agreement; and
WHEREAS, in connection therewith, and as an inducement to Roches and FMIs willingness to enter into the Transaction Agreement and to consummate the transactions contemplated thereby, FMI and Roche agree that Roche will work with FMI in the United States to educate relevant persons on next generation sequencing and/or comprehensive genomic profiling technology ( US Education Collaboration Agreement ), Roche and FMI will collaborate on the commercialization of certain FMI products outside of the United States ( Ex-US Commercialization Agreement ), and Roche and FMI may collaborate on development and commercialization of decentralized in vitro diagnostic (IVD) versions of FMI tests generated by FMI ( IVD Collaboration ), the above mentioned agreements, including the Transaction Agreement, being referred to collectively as the Related Agreements ; and
WHEREAS, FMI and Roche intend that assays and other products generated under this Agreement will be commercialized in accordance with the Ex-US Commercialization Agreement and that the governance structure under this Agreement will apply to the US Education Collaboration Agreement and the Ex-US Commercialization Agreement.
- 6 -
NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:
1. | Definitions |
As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:
1.1 | Affiliate |
The term Affiliate shall mean any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used in this definition of Affiliate, the term control shall mean the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. Anything to the contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co., Ltd, a Japanese corporation ( Chugai ), shall not be deemed an Affiliate of Roche unless Roche provides written notice to FMI of its desire to include Chugai as an Affiliate of Roche. Moreover, FMI and its Affiliates existing as of the Effective Date shall not be deemed Affiliates of Roche and its Affiliates existing as of the Effective Date, and Roche and its Affiliates existing as of the Effective Date shall not be deemed Affiliates of FMI and its Affiliates existing as of the Effective Date. Affiliates coming into existence after the Effective Date shall be classified by the Parties as either Roche Affiliates or FMI Affiliates for the purposes of this Agreement.
1.2 | Agreement |
The term Agreement shall mean this document including any and all appendices and amendments to it as may be added and/or amended from time to time in accordance with the provisions of this Agreement.
1.3 | Agreement Term |
The term Agreement Term shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated sooner as provided in Article 17, expiring on the date when all work has been completed or terminated under all R&D Plans.
1.4 | ALK ctDNA CTA |
The term ALK ctDNA CTA shall mean an analytical validated clinical ctDNA Assay [ *** ].
1.5 | Applicable Law |
The term Applicable Law shall mean any law, statute, ordinance, code, rule or regulation that has been enacted by a government authority (including without limitation, any Regulatory Authority) and is in force as of the Effective Date or comes into force during the Agreement Term, in each case to the extent that the same are applicable to the performance by the Parties of their respective obligations under this Agreement.
1.6 | Approved Assay |
The term Approved Assay means any assay or test intended for use in the diagnosis or evaluation of a disease or condition, excluding any IUO, and with respect to which any necessary Regulatory Approval is received in the relevant country, including PMA approval in the US, if applicable.
1.7 | Background IP |
The term Background IP shall mean all intellectual property rights, including Patent Rights and Know-How, Controlled by a Party as of the Effective Date and all intellectual property rights Controlled by a Party after the Effective Date but arising from activities other than the activities conducted under this Agreement. Roche Background IP specifically excludes the Excluded Patent Rights and no licenses are granted to FMI under such Excluded Patent Rights.
***Confidential Treatment Requested***
- 7 -
1.8 | Business Day |
The term Business Day shall mean 9.00am to 5.00pm local time on a day other than a Saturday, Sunday or bank or other public or federal holiday in Switzerland, New Jersey or Massachusetts.
1.9 | Calendar Half |
The term Calendar Half shall mean each period of six (6) consecutive calendar months, ending June 30 and December 31.
1.10 | Calendar Quarter |
The term Calendar Quarter shall mean each period of three (3) consecutive calendar months, ending March 31, June 30, September 30 and December 31.
1.11 | Calendar Year |
The term Calendar Year shall mean the period of time beginning on January 1 and ending December 31, except for the first Calendar Year which shall begin on the Effective Date and end on December 31.
1.12 | CDx |
The term CDx shall mean any Products or Services that require Regulatory Approval, including by any medical device Regulatory Authority, under the device authorities of the Federal Food, Drug, and Cosmetic Act (or equivalent medical device or in vitro diagnostic medical device regime in other countries) for use in connection with a decision to treat, or the specifics of the actual treatment, of person, with a specific product, as more fully described below:
(i) | identifying a person having a specific disease or condition, or a molecular genotype or phenotype that predisposes a person to such disease or condition, to support a decision to treat such person with such specific product, whether for prophylactic or therapeutic purposes; |
(ii) | defining the prognosis or monitoring the progress of a disease or condition in a person to support a decision to treat, or to continue to treat, such person with such specific product, whether for prophylactic or therapeutic purposes; |
(iii) | supporting the selection of a particular therapeutic or prophylactic regimen, wherein at least one (1) potential therapeutic or prophylactic regimen involves the use of such specific product; and/or |
(iv) | confirming such specific products biological activity and/or optimizing dosing or the scheduled administration of such specific product. |
1.13 | CDx Development Program |
The term CDx Development Program shall mean the program for development by FMI of CDx Assays for select Roche products.
1.14 | CLIA |
The term CLIA shall mean Clinical Laboratory Improvement Amendments as set forth by the Centers for Medicare & Medicaid Services which regulates all laboratory testing (except research) performed on humans in the U.S. and is certified by the Division of Laboratory Services, within the Survey and Certification Group, under the Center for Clinical Standards and Quality.
- 8 -
1.15 | Clinical Study |
The term Clinical Study shall mean a Phase I Study, Phase II Study, Phase III Study, as applicable.
1.16 | Commercially Reasonable Efforts |
The term Commercially Reasonable Efforts shall mean, with respect to the performance of an obligation under this Agreement, such quality and level of effort as is required to carry out such obligation in a sustained manner, consistent with the efforts Roche or FMI, as applicable, devotes to a similar obligation in connection with an internally developed product or service that is at the same stage of development or commercialization, as applicable, in a similar market, with similar market potential, at a similar stage of product life, taking into account the existence of other competitive products or services in the market place or under development, the proprietary position of the product or service, the regulatory structure involved, the anticipated profitability of the product or service and other relevant factors. It is understood that such quality and level if effort may change from time to time based upon changing scientific, business and marketing and return on investment considerations.
1.17 | Confidential Information |
The term Confidential Information shall mean any and all information, data or know-how (including Know-How), whether technical or non-technical, oral or written, that is disclosed by one Party or its Affiliates ( Disclosing Party ) to the other Party or its Affiliates ( Receiving Party ). Confidential Information shall not include any information, data or know-how that:
(i) | was generally available to the public at the time of disclosure, or information that becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party or its Affiliates, |
(ii) | can be evidenced by written records to have been already known to the Receiving Party or its Affiliates prior to its receipt from the Disclosing Party, |
(iii) | is obtained by the Receiving Party at any time lawfully from a Third Party under circumstances permitting its use or disclosure, |
(iv) | is developed independently by the Receiving Party or its Affiliates as evidenced by written records other than through knowledge of Confidential Information, or |
(v) | is approved in writing by the Disclosing Party for release by the Receiving Party. |
The terms of this Agreement shall be considered Confidential Information of the Parties.
1.18 | Control |
The term Control shall mean (as an adjective or as a verb including conjugations and variations such as Controls Controlled or Controlling) (a) with respect to Patent Rights and/or Know-How, the possession by a Party of the ability to grant a license or sublicense of such Patent Rights and/or Know-How as provided herein without violating the terms of any agreement or arrangement between such Party and any other party, where such ability derives from rights other than an assignment or license granted herein and (b) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any other party.
- 9 -
1.19 | Cover |
The term Cover shall mean (as an adjective or as a verb including conjugations and variations such as Covered, Coverage or Covering) that the developing, making, using, offering for sale, promoting, selling, exporting or importing of a given product would infringe a valid claim under the Patent Rights. As used in the previous sentence, valid claim means, with respect to a particular country a claim in an issued and unexpired patent that has not lapsed or been disclaimed, revoked, held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed fo appeal and that has not been admitted to be invalid or unenforceable through re-examination, re-issue, disclaimer or otherwise, or lost in an interference proceeding.
1.20 | ctDNA |
The term ctDNA shall mean circulating tumor DNA.
1.21 | ctDNA Assay |
The term ctDNA Assay shall mean an assay developed on or utilizing FMIs ctDNA Platform (including instruments and software) for the detection of genomic alteration in ctDNA, including an RUO, IUO and Approved Assay.
1.22 | ctDNA Platform |
The term ctDNA Platform shall mean Products or Services for testing of specimens to identify genomic alterations in ctDNA as a blood-based liquid biopsy, including FMI instruments, analytical methods, algorithms, procedures, techniques, software or platforms, intended for use in genomic analysis, and related technologies and any improvements to the foregoing, in each case Controlled by FMI as of the Effective Date or during the Agreement Term.
1.23 | ctDNA Platform Development Program |
The term ctDNA Platform Development Program shall mean the program for development of ctDNA analysis platform by FMI for effective genomic profiling from liquid biopsy.
1.24 | ctDNA Working Group |
The term ctDNA Working Group shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the ctDNA Platform Development Program a set forth herein.
1.25 | Data Security Breach |
The term Data Security Breach means (a) the disclosure or misuse (by any means) of Personal Data; (b) the inadvertent, unauthorized and/or unlawful processing, access, disclosure, alteration, corruption, transfer, sale or rental, destruction or use of Personal Data; or (c) any other act or omission that compromises the security, confidentiality, and/or integrity of Personal Data.
1.26 | Effective Date |
The term Effective Date shall mean the latest of (a) the date of the last signature of this Agreement, or (b) if a HSR filing is made, the second Business Day immediately following the earlier of: (i) the date upon which the waiting period under HSR expires or terminates early or (ii) the date upon which all requests to the Parties by the Federal Trade Commission or the Justice Department, as the case may be, with regard to the transaction contemplated by this Agreement
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have been satisfactorily met and no objection on the part of the Federal Trade Commission or the Justice Department remains, or (c) the occurrence of the Acceptance Time (as defined in the Transaction Agreement).
1.27 | Excepted Activities |
The term Excepted Activities shall mean [ *** ].
1.28 | Excluded Patent Rights |
The term Excluded Patent Rights shall mean those Patent Rights listed in Appendix 1.28.
1.29 | FDA |
The term FDA shall mean the Food and Drug Administration of the United States of America.
1.30 | FDCA |
The term FDCA shall mean the Food, Drug and Cosmetics Act.
1.31 | FMI Background IP Patent Rights |
The term FMI Background IP Patent Rights means Patent Rights that Cover Background IP that is Controlled by FMI.
1.32 | FMI Decisions |
The term FMI Decisions shall mean decisions with respect to any of the following issues that come before the JMC:
(i) | Conduct of the Molecular Information Platform Program, including the Genomic Analysis Platform and the Molecular Information Database; |
(ii) | Performance by FMI of Sample Profiling in excess of what can be performed through the use of the Reserved Capacity; |
(iii) | ctDNA Platform Development pursuant to Section 6.1.5.2; and |
(iv) | Performance Specifications for Products and Services (e.g., sensitivity, specificity, sample input requirements, and error rate), algorithmic elements, and other gene or marker content for CDx Assay, in each case, that do not pertain to Investigational Markers or Approved Markers specified under the CDx R&D Plan. |
1.33 | FMI Development Costs |
The term FMI Development Costs means all costs reasonably incurred or committed to by FMI to perform its obligations and activities hereunder, including without limitation, (i) personnel costs equal to the number of FTEs used to perform such obligations and activities multiplied by the FTE Rate, (ii) out-of-pocket costs for consultants, materials and services and (iii) facilities costs reasonably allocated to performance of such obligations and activities, including acquisition, maintenance and operation costs for such facilities.
1.34 | FMI Know-How |
The term FMI Know-How shall mean the Know-How that FMI Controls at the Effective Date and during the Agreement Term.
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1.35 | FMI Foreground Patent Rights |
The term FMI Foreground Patent Rights shall mean the Patent Rights that FMI Controls and that Cover Inventions conceived of and reduced to practice after the Effective Date in the performance of the activities under this Agreement, excluding any Joint Patent Rights and any FMI Background IP Patent Rights.
1.36 | FTE |
The term FTE shall mean a full-time equivalent person-year, based upon a total of no less than one thousand eight hundred (1,800) working hours per year, undertaken in connection with the conduct of research in a Work Stream. In no circumstance can the work of any given person exceed one (1) FTE.
1.37 | FTE Rate |
The term FTE Rate shall mean the amount of [ *** ], on a fully burdened cost basis, which amount shall be subject to increase following the [ *** ] anniversary of the Effective Date by an amount equal to the increase in the Consumer Price Index as published by the U.S. Department of Labor, Bureau of Labor Statistics (the CPI ) between the Effective Date and such date for a new FTE Rate not to exceed [ *** ] per FTE, and which such new FTE Rate shall be subject to subsequent increases upon the date of each renewal or extension period comprising the Agreement Term by an amount equal to the increase in the CPI as of such date.
1.38 | Handle |
The term Handle shall mean all activities associated with prosecution and maintenance of a particular patent and patent application(s) derived from such patent, including preparing, filing, prosecuting and maintaining (including interferences, reissue, re-examination, pre- and post-grant proceedings, inter-parties reviews, derivation proceedings, applications for patent term adjustment and extensions, supplementary protection certificates and oppositions and other similar proceedings).
1.39 | HSR |
The term HSR shall mean the Hart-Scott-Rodino Antitrust Improvements Act.
1.40 | Immunotherapy Testing Platform Development Program |
The term Immunotherapy Testing Platform Development Program shall mean the program for development of an immunotherapy testing platform.
1.41 | Immuno-Platform Working Group |
The term Immuno-Platform Working Group shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the Immunotherapy Testing Platform Development Program.
1.42 | Initiation |
The term Initiation shall mean the date that a human is first dosed with the drug in a Clinical Study approved by the respective Regulatory Authority.
1.43 | Insolvency Event |
The term Insolvency Event shall mean circumstances under which a Party (i) has a receiver or similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any jurisdiction); (iii) enters into
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any composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv) ceases to carry on business; (v) is unable to pay its debts as they become due in the ordinary course of business.
1.44 | Invention |
The term Invention shall mean an invention that is made, i.e. conceived and reduced to practice, in performance of activities under this Agreement. Under this definition, an Invention may be made by solely by individuals having an obligation to assign rights in such invention to FMI (an FMI Invention ), solely by individuals having an obligation to assign rights in such invention to Roche (a Roche Invention), or jointly by individuals having an obligation to assign rights in such invention to FMI and individuals having an obligation to assign rights in such invention to Roche (a Joint Invention ).
1.45 | IUO |
The term IUO shall mean an assay for investigational use only that meets certain clinical and manufacturing standards and which is used in clinical studies to gather data for submission to a Regulatory Agency in support of an Approved Assay.
1.46 | JMC |
The term JMC shall mean the joint management committee described in Article 6.
1.47 | JOC |
The term JOC shall mean the joint operating committee as mentioned in Section 6.3 and described in the Ex-US Commercialization Agreement.
1.48 | Joint Know-How |
The term Joint Know-How shall mean Know-How that is made jointly by the Parties or their Affiliates or their Sublicensees in performance of activities carried out pursuant to this Agreement.
1.49 | Joint Patent Rights |
The term Joint Patent Rights shall mean all Patent Rights Covering a Joint Invention.
1.50 | JOT |
The term JOT shall mean a joint operating team described in Section 6.1.7.
1.51 | JRDC |
The term JRDC shall mean the joint research and development committee described in Section 6.2.
1.52 | Know-How |
The term Know-How shall mean data, knowledge, algorithms, business rules and information, including manufacturing data, toxicological data, pharmacological data, preclinical data, formulations, specifications, quality control testing data, which are necessary or useful for the discovery, manufacture, development or commercialization of Products and Services.
1.53 | Molecular Information Platform Program |
The term Molecular Information Platform Program shall mean the program designed to generate insights for certain of Roches clinical development portfolio from FMIs molecular information platform, comprised of tumor sample genomic analysis, database access, and dedicated FMI clinical and genomic expertise.
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1.54 | Molecular Information Platform Working Group |
The term Molecular Information Platform Working Group shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the Molecular Information Platform Program.
1.55 | Party |
The term Party shall mean FMI or Roche, as the case may be, and Parties shall mean FMI and Roche collectively.
1.56 | Patent Rights |
The term Patent Rights shall mean all rights under any patent or patent application, in any country of the Territory, including any patents issuing on such patent application, and further including any substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, division, continuation or continuation-in-part of any of the foregoing.
1.57 | Performance Specifications |
The term Performance Specifications shall mean a set of minimum standards and specifications related to FMIs supply and delivery of Products and Services under this Agreement as set forth in the R&D Plans for each Work Stream or Task Orders, including standards with respect to classes of alterations detected and sequencing sensitivity and specificity (based on tissue requirements); provided, however, the Performance Specifications for the Molecular Information Platform Program are attached hereto as Exhibit 1.57.
1.58 | Personal Data |
The term Personal Data shall mean any information that can be used to identify, locate or contact an individual (a Data Subject ), including but limited to, (a) first name or initial and last name; (b) home or other physical address; (c) telephone number; (d) email address or online identifier associated with the individual; (e) social security number or other similar identifier; (f) employment financial or health information; or (g) any other information relating to an individual that is combined with any of the above.
1.59 | Phase I Study |
The term Phase I Study shall mean a human clinical trial in any country that would satisfy the requirements of 21 C.F.R. § 312.21(a) (FDCA), as amended from time to time, and the foreign equivalent thereof.
1.60 | Phase II Study |
The term Phase II Study shall mean a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.
1.61 | Phase III Study |
The term Phase III Study shall mean a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.
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1.62 | PMA |
The term PMA shall mean a premarket approval application as defined under section 515 of the FDCA.
1.63 | Quality Standards |
The term Quality Standards shall mean CLIA or QSR requirements, each as applicable, and other Applicable Laws. If requested by Roche, the JRDC will establish which such quality standards specifically apply to Products and Services within a given Work Stream.
1.64 | R&D Plan |
The term R&D Plan shall mean a plan of research and development for each Work Stream other than the Molecular Information Platform Program. The initial R&D Plans are attached as Appendix 1.64 and outline the work expected to be performed by FMI for the relevant Work Stream. Such plans may be updated from time to time as provided in this Agreement.
1.65 | Regulatory Approval |
The term Regulatory Approval shall mean any approvals, licenses, registrations, authorizations, or certifications by Regulatory Authority or any CE markings, necessary for the manufacture, sale or putting into service of a product in a regulatory jurisdiction in the Territory.
1.66 | Regulatory Authority |
The term Regulatory Authority shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the FDA, in each country involved in the granting of Regulatory Approval for a product or service.
1.67 | Roche Background IP Patent Rights |
The term Roche Background IP Patent Rights means Patent Rights that Cover Background IP that is Controlled by Roche.
1.68 | Roche Group |
The term Roche Group shall mean collectively Roche, its Affiliates and its Sublicensees, excluding FMI and FMI Affiliates.
1.69 | Roche Know-How |
The term Roche Know-How shall mean all Know-How that Roche Controls during the Agreement Term.
1.70 | Roche Foreground Patent Rights |
The term Roche Foreground Patent Rights shall mean the Patent Rights that Roche Controls (other than through licenses granted under this Agreement) and that Cover Inventions conceived of and reduced to practice after the Effective Date in the performance of the activities under this Agreement, excluding any Joint Patent Rights and the Excluded Patent Rights.
1.71 | ROW Territory |
The term ROW Territory shall mean all countries of the world excluding the US.
1.72 | RUO |
The term RUO shall mean an assay intended or approved for research use only.
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1.73 | Study Data |
The term Study Data shall mean all data related to any Data Subject collected by or transferred to the Roche Group or business partners, in connection with any services that FMI may provide to Roche.
1.74 | Sublicensee |
The term Sublicensee shall mean an entity to which Roche or FMI, as applicable, has licensed rights (through one or multiple tiers), other than through a Compulsory Sublicense, pursuant to this Agreement.
1.75 | Territory |
The term Territory shall mean the US and the ROW Territory.
1.76 | Third Party |
The term Third Party shall mean a person or entity other than (i) FMI or any of its Affiliates or (ii) a member of the Roche Group.
1.77 | US |
The term US shall mean the United States of America and its territories and possessions.
1.78 | US$ |
The term US$ shall mean US dollars.
1.79 | Work Stream |
The term Work Stream shall mean each of the Molecular Information Platform Program, Immunotherapy Testing Platform Development Program, the ctDNA Platform Development Program, and the CDx Development Program.
1.80 | Additional Definitions |
Each of the following definitions is set forth in the Section of this Agreement indicated below:
Definition |
Section |
|
AAA |
19.3 | |
Accounting Period |
9.1 | |
Advanced Genomic Analyses |
3.1.4 | |
Alliance Director |
6.2 | |
Approved Markers |
3.4.1 | |
Assessment |
10 | |
Bankruptcy Code |
18 | |
Binding Orders |
3.1.5 | |
Biomarker IP |
2.1.2 | |
Breaching Party |
17.2.1 | |
CDx Assays |
3.4.1 | |
CDx Platform Working Group |
3.4.2 | |
Chairperson |
6.1.1 | |
Competent Authority Procedures |
10 | |
ctDNA Milestone Date |
8.4 | |
Create Act |
12.6 | |
Database Renewal Term |
3.1.9 | |
Database Queries |
3.1.8 |
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Definition |
Section |
|
Data Subject |
1.57 | |
Decision Period |
12.5 | |
Disclosing Party |
1.17 | |
Ex-US Collaboration Agreement |
Whereas Clause | |
First ctDNA Milestone Date |
8.4 | |
FMI CDx IP |
12.1.5 | |
FMI-Derived Advanced Genomic Analysis Results |
3.1.8 | |
FMI Improvement IP |
12.1.2 | |
FMI Invention |
1.44 | |
Immuno-Biomarker Discovery Platform |
3.2.1 | |
Immuno-Clinical Study Assays |
0 | |
Immunotherapy Exclusivity Period |
3.2.8 | |
Immunotherapy Testing Platform Development Budget |
8.3.1 | |
Genomic Analyses |
3.1.4 | |
Indemnified Party |
14.3 | |
Indemnifying Party |
14.3 | |
Initial Roche ctDNA Assay |
8.4 | |
Initiating Party |
12.5 | |
Investigational Markers |
3.4.1 | |
IVD Collaboration |
Whereas Clause | |
Joint Invention |
1.44 | |
Materially Modified |
8.3.2(i) | |
Members |
6.1.1 | |
Molecular Information Database |
3.1.8 | |
Molecular Information Database Access |
3.1.8 | |
Non-Breaching Party |
17.2.1 | |
Payment Currency |
9.3 | |
Peremptory Notice Period |
17.2.1 | |
Products and Services |
7 | |
Profiling Renewal Term |
3.1.9 | |
Profiling Term |
3.1.9 | |
Publishing Notice |
16.4 | |
Publishing Party |
16.4 | |
Receiving Party |
1.17 | |
Related Agreements |
Whereas Clause | |
Reserved Capacity |
3.1.4 | |
Reserved Capacity Fees |
8.2.1.1 | |
Roche CDx Development IP |
12.1.5 | |
Roche ctDNA Sample Results |
12.1.4 | |
Roche Immunotherapy Sample Results |
12.1.3 | |
Roche Improvement IP |
12.1.2 | |
Roche Invention |
1.44 | |
Roche-Owned Advanced Genomic Analysis Results |
12.1.2 | |
Roches Jurisdiction |
10 | |
Sample Profiling |
3.1.4 |
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Definition |
Section |
|
Sample Results |
3.1.6 | |
Second ctDNA Milestone Date |
8.4 | |
Settlement |
12.5 | |
Signature Identification |
3.2.1 | |
Suit Notice |
12.5 | |
Task Orders |
3.1.3 | |
TPP |
6.1.5.2 | |
Transaction Agreement |
Whereas Clause | |
US Education Collaboration Agreement |
Whereas Clause |
2. | Grant of License |
2.1 | Licenses |
2.1.1 | Research and Development Cross License |
Each Party grants to the other Party during the time that a Work Stream is in effect, a non-exclusive right and license under Know-How and Patent Rights, including the Background IP, Controlled by such Party and that are necessary or useful solely to enable the other Party to perform the activities contemplated under this Agreement; [ *** ].
2.1.2 | Molecular Information Platform Licenses |
Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide and perpetual license, sublicensable to FMIs Affiliates, under any intellectual property rights arising directly from the Sample Results, or the correlation of the Sample Results to patient data ( Biomarker IP ) (i) to the extent such Biomarker IP becomes publicly known, for internal research purposes, (ii) to the extent such Biomarker IP becomes publicly known, to develop, make, have made, use, offer for sale, sell, import, and commercialize FMIs Products and Services relating to genomic analysis, and (iii) [ *** ].
Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide and perpetual license, sublicensable to Affiliates, to use the Roche-Owned Advanced Genomic Analysis Results to develop, make, have made, use, offer for sale, sell, import and commercialize FMIs products and services relating to genomic analysis.
FMI hereby grants to Roche a non-exclusive, royalty-free, worldwide and perpetual license, sublicensable to Roches Affiliates under any FMI Improvements for Roches internal research purposes and to develop, make, have made, use, offer for sale, sell, import and commercialize Roches products and services other than diagnostic products and services.
2.1.3 | Immunotherapy Testing Platform Licenses |
Effective after the Immunotherapy Exclusivity Period, Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide, perpetual, and sublicensable to Affiliates, license to any intellectual property arising from the Immunotherapy Testing Platform Development Program Controlled by Roche (excluding Roche Immunotherapy Sample Results) to the extent necessary
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for FMI to develop, make, have made, use, offer for sale, sell, import and commercialize the Immuno-Biomarker Discovery Platform, Signature Identification services, Clinical Study assays, CDx assays, or any other FMI testing or services (including that are part of the Genomic Analysis Platform).
FMI hereby grants to Roche a non-exclusive, royalty-free, worldwide, perpetual, and sublicensable license to any intellectual property arising from the Immunotherapy Testing Platform Program Controlled by FMI for internal research purposes and to the extent necessary for Roche to research, develop, make, have made, use, offer for sale, sell, import and commercialize Roche products other than diagnostic products.
If FMI is unable or unwilling to develop and commercialize an Immuno Clinical Study assay or CDx assay resulting from the Immunotherapy Testing Platform Development Program in a given country within the Territory as specified in an R&D Plan for any reason other than a breach of this Agreement by Roche, and on the timeline agreed to in such R&D Plan, then, effective on the end of the timeline specified in such R&D Plan, FMI hereby grants to Roche a non-exclusive, royalty-free, perpetual, and sublicensable license under any intellectual property invented by FMI arising from the Immunotherapy Testing Platform Program or the Immunotherapy Testing Platform Development that is necessary for Roche to develop and commercialize such tests in such country in the Territory.
2.1.4 | ctDNA Licenses |
FMI hereby grants to Roche (i) an exclusive, royalty-free, sublicensable, worldwide and perpetual license to any intellectual property rights arising from the ctDNA Development Platform Program that are necessary for Roche to develop, make, have made, use, offer for sale, sell, import and commercialize Roche products other than diagnostic products (including the use, formulation, methods of treatment, clinical data or other data, information or results relating to the Roche therapeutic product) solely for use in connection with such activities and such Roche products and (ii) a non-exclusive, royalty-free, worldwide and perpetual license, with the right to grant sublicenses solely to Roche Affiliates, to any intellectual property rights arising from the ctDNA Development Platform Program, for internal research purposes.
Roche hereby grants to FMI a non-exclusive, royalty-free, worldwide, perpetual, and sublicensable license to any IP Controlled by Roche and developed under the ctDNA Platform Development Program (excluding Roche Immunotherapy Sample Results) to the extent necessary for FMI to research, develop, make, have made, use, offer for sale, sell, import and commercialize the ctDNA Assays.
2.1.5 | CDx Development Program |
FMI hereby grants to Roche a non-exclusive license under the FMI CDx IP for internal research purposes, and to the extent necessary to research, develop, make, have made, use, offer for sale, sell, import and commercialize Roche products other than diagnostic products.
If FMI is unwilling or unable to develop and commercialize a CDx Assay for a given country in the Territory as specified in the R&D Plan, and on the timeline set forth in the relevant R&D Plan, for any reason other than a breach of this Agreement by Roche, then FMI hereby grants to Roche a non-exclusive, royalty-free, sublicensable, and perpetual license under any intellectual property invented by FMI arising from the CDx Development Program that is necessary for Roche to develop and commercialize a CDx Assay equivalent in such country in the Territory.
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2.2 | Sublicense |
Except as otherwise provided herein, where the right to sublicense is granted under this Agreement, the licensee shall have the right to sublicense, and subcontract (subject to Section 2.3), through multiple tiers. Each sublicense granted hereunder to a Third Party shall be pursuant to a written agreement. Each sublicense granted hereunder by a Party shall include restrictions on the disclosure of the other Partys Confidential Information that are substantially similar to the protections provided herein. Each Party shall be liable for any action or failure to act by a sublicensee under a sublicense granted by such Party to the extent such action or failure to act on the part of such Party would constitute a breach of this Agreement by such Party.
2.3 | Right to Subcontract |
Each Party shall have the right to subcontract the work performed under this Agreement in accordance with the applicable R&D Plan. Each such subcontract with a Third Party shall be pursuant to a written agreement. Each such subcontract by a Party shall include restrictions on the disclosure of the other Partys Confidential Information that are substantially similar to the protections provided herein. Each Party shall be liable for any action or failure to act by a subcontractor under a subcontract entered into by such Party to the extent such action or failure to act on the part of such Party would constitute a breach of this Agreement by such Party.
3. | Research and Development Collaboration |
3.1 | Molecular Information Platform Program |
3.1.1 | Scope |
Roche and FMI shall conduct the Molecular Information Platform Program pursuant to this Agreement under the direction of the Molecular Information Platform Working Group.
3.1.2 | Molecular Information Platform Working Group |
The Parties shall establish the Molecular Information Platform Working Group within sixty (60) days after the Effective Date to operationalize the Molecular Information Platform Program. The Molecular Information Platform Working Groups activities will be overseen by JRDC.
3.1.3 | Task Orders |
The Parties will conduct the Molecular Information Platform Program in accordance with agreed upon task orders ( Task Orders ) and in compliance with Performance Specifications and Quality Standards. Each Task Order will be substantially in the form set forth in Appendix 3.1.3. To the extent any terms set forth in a Task Order conflict with the terms set forth in this Agreement, the terms of this Agreement shall control.
3.1.4 | Sample Profiling and Reserved Capacity |
FMI shall provide, and shall reserve capacity to provide, Roche with comprehensive profiling, analysis and reporting ( Sample Profiling ) of at least [ *** ] during the first [ *** ] immediately following the Effective date, and at least [ *** ] samples during the next [ *** ]
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( Reserved Capacity ) using FMIs platform for molecular genomic profiling of cancer samples (the Genomic Analysis Platform ). The initial laboratory and computational biology activities performed on the Samples as part of Sample Profiling are Genomic Analyses . FMI will provide Sample Profiling in accordance with the Reserved Capacity during the Profiling Term and Profiling Renewal Term, using the then-current versions of the tests included in its Genomic Analysis Platform. The Sampling Profiles shall be provided in a specified format to be mutually agreed by the Parties. The JMC will discuss and decide upon the Reserved Capacity commitment for Profiling Renewal Terms, provided that any Reserved Capacity amount in excess of [ *** ] that would require FMI to increase its existing capacity will require FMI approval.
Sample Profiling will include advanced genomic analyses, i.e. advanced laboratory and computational biology activities in the field of cancer genomic sequencing and analysis performed on Samples, including [ *** ] (collectively, Advanced Genomic Analyses ). Sample Profiling includes Genomic Analyses and Advanced Genomic Analyses.
FMI may adopt modifications to the Performance Specifications without Roches consent, so long as such modifications do not result in a material diminution in the analytical performance of the Genomic Analysis Platform as measured by the metrics set forth in Appendix 1.57 (which such material diminution would require the prior written consent of Roche). In the event [ *** ], and such change results in a material diminution in the analytical performance of the Genomic Analysis Platform as measured by the metrics set forth in Appendix 1.57, Roche may, at its election, and upon written notice to FMI, terminate each Partys obligations under Reserved Capacity, including Roches obligations under Section 8.2.1.1 to pay Reserved Capacity Fees and opt out of the price per Sample fees for Sample Profiling otherwise specified in Section 8.2.1.2, in each case, from the effect of such sequencing platform change. If Roche elects to terminate the Parties obligations under Reserved Capacity and opts out of the per Sample pricing for Sample Profiling specified in Section 8.2.1.2, Sample Profiling shall then be performed, and fees for such Sample Profiling shall then be charged, on a per Sample basis at FMIs standard rates or on pricing terms to be mutually agreed in writing by the Parties (or as otherwise mutually agreed in writing by the Parties).
3.1.5 | Forecasting and Binding Orders |
Not later than the first Business Day of [ *** ] during the Profiling Term and Profiling Renewal Terms, Roche will provide FMI with a rolling forecast of its estimated requirements for Sample Profiling for the following [ *** ], the rolling forecast for the [ *** ] of which shall be deemed to be a binding order for sample volume (including specifications for the number of samples to be run using each of FMIs different tests) ( Binding Orders ). Binding Orders will not impact FMIs commitment to provide services for at least the Reserved Capacity amount, and Roches financial commitment to pay the Reserved Capacity Fee. FMI shall use Commercially Reasonable Efforts to fulfill requests for Sample Profiling exceeding the Reserved Capacity based on forecasts provided by Roche (each a Forecast ) in advance of [ *** ] as specified below.
3.1.6 | Samples, Sample Results, Web-Portal |
Roche will provide samples to FMI for Sample Profiling as provided for in Section 3.5. The results of the Sample Profiling ( Sample Results ) shall be provided by FMI to Roche in a timeframe to be agreed upon by the Parties. A sample report is attached as Appendix 3.1.6.
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FMI will set up and utilize a basic web-portal for Roche to access Sample Results and patient reports for Roche Clinical Studies. This web-portal shall be similar to the portal that FMI provides to its other major pharmaceutical customers.
3.1.7 | Clinical Reports |
FMI will provide Roche with clinical (e.g., FoundationOne® or FoundationOne® Heme) reports from Sample Profiling on reasonable request, to be specified in applicable Task Orders, to enable Roche to provide comprehensive information to physicians and patients.
3.1.8 | Database Insights |
FMI will provide molecular information insights ( Database Insights ) arising from FMIs database of aggregated clinical genomic analysis results, which include genomic alterations (base substitutions, insertions and deletions, copy number alterations, and rearrangements) detected by the Genomic Analysis Platform across FMIs clinical testing experience in all disease ontologies (the Molecular Information Database ), in response to queries supplied by Roche ( Database Queries ) or generated by FMI in response to discussions between the Parties about areas of interest for Roche (e.g., [ *** ]), utilizing a team of [ *** ] FMI FTEs with requisite training and experience to generate Database Insights ( Molecular Information Database Access ).
Database Insights and results of Advanced Genomic Analyses performed against the Molecular Information Database (which, for clarity, does not include Roches Sample Results) ( FMI-Derived Advanced Genomic Analysis Results ) shall be deemed FMI Confidential Information. Roche and its Affiliates may use the Database Query Results and FMI-Derived Advanced Genomic Analysis Results for all purposes, except that Roche may not disclose the Database Query Results to Third Parties, other than as necessary for development, approval or commercialization of a therapeutic or diagnostic product owned or controlled by Roche, or as otherwise consistent with the terms of confidentiality contained in the Definitive Agreement.
3.1.9 | Molecular Information Database Access |
As set forth in Section 3.1.8, FMI will provide Roche mediated (indirect through dedicated FMI FTEs) access to the Molecular Information Database to pose Database Queries and will provide the resulting Database Insights to Roche in a format to be mutually agreed by the Parties. FMI will also provide Roche with direct access to the Molecular Information Database for Roche to perform Database Queries and generate Database Insights, when such service is made available to Third Parties by FMI in the ordinary course of business.
3.1.10 | Duration and Extension |
The term for Sample Profiling set forth in Section 3.1.4 shall commence on the Effective Date and continue for five (5) years thereafter (the Profiling Term ). The Profiling Term may be extended at Roches option, upon [ *** ] written notice to FMI as specified in Section 19.13, for additional three (3) year periods, during any period of time in which Roche is a majority shareholder of FMI (each a Profiling Renewal Term ).
The term for Database Insights under Section 3.1.8 shall commence on the Effective Date and continue for five (5) years thereafter (the Database Insights Term ). The Database Insights
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Term may be extended at Roches option, upon [ *** ] written notice to FMI as specified in Section 19.13, for additional three (3) year periods, during any period of time in which Roche is a majority shareholder of FMI (each a Database Renewal Term ).
During any Profiling Renewal Term and/or Database Renewal Term, if FMI increases the fees it charges to Third Parties for Sample Profiling and/or Database Insights, then FMI will notify Roche of such adjustment(s), and the Parties shall agree upon the fees to be charged to Roche during the Profiling Renewal Term and/or Database Renewal Term, subject to Article 5, for such Profiling Renewal Term and/or Database Renewal Term prior to its commencement.
If FMI is unable to provide Roche with the Reserved Capacity, or to provide Roche with deliverables meeting Performance Specifications for the Sample Profiling or the Database Queries or fails to comply with Quality Standards, then Roche will have the right to terminate the Sample Profiling and/or Database Insights, as applicable, as set forth in Section 17.3.3, subject to the notice and cure provisions therein.
3.2 | Immunotherapy Testing Platform Development Program |
3.2.1 | Scope |
Roche and FMI shall conduct the Immunotherapy Testing Platform Development Program pursuant to a mutually agreed R&D Plan under the direction of the Immuno-Platform Working Group. The purpose of the Immunotherapy Testing Platform Development Program is to develop an immunotherapy testing platform meeting the specifications set forth by the Immuno-Platform Working Group for profiling of cancer immunotherapy patients (the Immuno-Biomarker Discovery Platform ). The Parties hope to further deploy the platform for use in Clinical Study sample profiling to identify possible signatures for immunotherapy response ( Signature Identification ). Roche may also, at its option, request that FMI develop CLIA immunotherapy testing Clinical Study assays for use in selecting or differentiating patients in Roche Clinical Studies in immuno-oncology ( Immuno-Clinical Study Assays ).
3.2.2 | Immuno-Platform Working Group |
The Parties shall establish the Immuno-Platform Working Group within sixty (60) days after the Effective Date to operationalize the Immunotherapy Testing Platform Development. The Immuno-Platform Working Groups activities will be overseen by JRDC.
The Immuno-Platform Working Group shall serve as a forum for discussion and sharing updates and information between the Parties, but shall have no decision-making authority. The Immuno-Platform Working Group shall:
(i) | serve as a forum for discussing the development of the Immuno-Biomarker Discovery Platform and related Products and Services, as well as Immuno-Clinical Study Assays, if applicable; |
(ii) | serve as a forum for coordinating the Parties efforts to carry out the R&D Plan; |
(iii) | periodically monitor progress of activities under the R&D Plan and discuss any obstacles or delays with regard to achieving the timelines set forth therein; |
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(iv) | discuss the overall strategy, including the submission plans, for obtaining and maintaining Regulatory Approval of any of the Products and Services developed in the Immunotherapy Testing Platform Development Program; and |
(v) | such other responsibilities as may be assigned to the Immuno-Platform Working Group in or pursuant to this Agreement or as may be mutually agreed by the Parties in writing. |
3.2.3 | R&D Plan |
The Parties will conduct the Immunotherapy Testing Platform Development Program in accordance with an R&D Plan and in compliance with Performance Specifications and Quality Standards. Unless decided otherwise by the JMC, the R&D Plan will be updated [ *** ] by the Immuno-Platform Working Group, reviewed and recommended for approval by the JRDC and approved by the JMC. The R&D Plan will set forth (i) the scope of the Immunotherapy Testing Platform Development Program and the FTE resources that will be dedicated to the activities contemplated within the scope of the Immunotherapy Testing Platform Development Program, including the responsibilities of each Party (ii) an overall timeline and specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRDC as research progresses, and (iii) budgets for such activities. The Parties shall update the R&D Plan no later than [ *** ] before the first anniversary of the Effective Date. The JRDC shall review the R&D Plan on an ongoing basis and may amend the R&D Plan. Any such changes shall be reflected in written amendments to the R&D Plan.
3.2.4 | Responsibilities of the Parties |
FMI will work with Roche in accordance with the R&D Plan to develop the Immuno-Biomarker Discovery Platform, perform Signature Identification, and, as requested by Roche, develop Immuno Clinical Study Assays. Except for the contracts listed on Appendix 3.2.4, the Parties will meet and discuss existing contracts for activities that are Excepted Activities, and enact a plan for winding-down such contracts, where appropriate.
Roche will work with FMI in accordance with the R&D Plan established by the Immuno-Platform Working Group, including by providing relevant samples and associated data, immuno-oncology expertise, and bioinformatics support, in each case to the extent agreed to in the R&D Plan.
3.2.5 | Budget |
A budget for the anticipated work for the Immunotherapy Testing Platform Development forms a part of the R&D Plan. Any changes to this budget shall be reviewed by the JRDC and then submitted to the JMC for approval.
3.2.6 | Duration |
The initial term of the Immunotherapy Testing Platform Development Program will be five (5) years beginning on the Effective Date.
3.2.7 | Extension |
Roche shall have the right to extend the Immunotherapy Testing Platform Development Program, upon [ *** ] written notice to FMI as specified in Section 19.13, for up to six (6)
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additional one (1) year periods, during any period of time in which Roche is a majority shareholder of FMI (each a Signature Identification Renewal Term ), provided, for clarity, that during any Signature Identification Renewal Term, FMIs obligations under Section 16.1 shall continue to apply to any signature identified under this Agreement but that exclusivity under Section 3.2.8 shall not apply to the Immuno-Biomarker Discovery Platform.
3.2.8 | Exclusivity |
Except for Excepted Activities, for the lesser of (i) five (5) years after the Effective Date or (ii) [ *** ] (the Immunotherapy Exclusivity Period ), FMI will work exclusively with Roche with respect to [ *** ]. Except with regard to Excepted Activities, FMI will not (i) work directly or indirectly with any Third Party in the field of [ *** ], (ii) use for the benefit of any Third Party the [ *** ] or (iii) transfer to or otherwise enable any Third Party to make use of any data, technology or results from the Immunotherapy Testing Platform Development Program for [ *** ].
Following the Immunotherapy Exclusivity Period, FMI shall have the right to work with Third Parties in the field of cancer immunotherapy, and to otherwise commercialize the Immuno-Biomarker Discovery Platform, subject to the Related Agreements.
3.2.9 | Excepted Activities |
For any Excepted Activities, FMI shall provide copies of proposed publications Roche for review in accordance with Section 16.4.
3.2.10 | Discount |
For the first [ *** ] following commercial launch by FMI of any Immuno Clinical Study Assay(s) created during or derived from the Immunotherapy Testing Platform Development, Roche and its Affiliates will be entitled to [ *** ], for the purchase of any such Immuno Clinical Study Assay(s).
3.3 | ctDNA Platform Development Program |
3.3.1 | Scope |
Roche and FMI shall conduct the ctDNA Platform Development Program, pursuant to a mutually agreed R&D Plan under the direction of the ctDNA Working Group. The purpose of the ctDNA Platform Development Program is to develop ctDNA Assays meeting the specifications set forth in the R&D Plan.
3.3.2 | Working Group |
The Parties shall establish the ctDNA Working Group within sixty (60) days after the Effective Date to operationalize the ctDNA Platform Development. The ctDNA Working Groups activities will be overseen by JRDC.
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The ctDNA Working Group shall serve as a forum for discussion and sharing updates and information between the Parties, but shall have no decision-making authority. The ctDNA Working Group shall:
(i) | serve as a forum for discussing the development of the ctDNA Platform and ctDNA Products; |
(ii) | serve as a forum for coordinating the Parties efforts to carry out the R&D Plan; |
(iii) | periodically monitor progress of activities under the R&D Plan and discuss any obstacles or delays with regard to achieving the timelines set forth therein; |
(iv) | discuss the overall strategy, including the submission plans, for obtaining and maintaining Regulatory Approval of any of the ctDNA Products; and |
(v) | such other responsibilities as may be assigned to the ctDNA Working Group in or pursuant to this Agreement or as may be mutually agreed by the Parties in writing. |
3.3.3 | R&D Plan |
FMI will develop the ctDNA Assays, leveraging ongoing efforts, in accordance with the R&D Plan and in compliance with Performance Specifications and Quality Standards. Unless decided otherwise by the JMC, the R&D Plan will be updated [ *** ] by the ctDNA Working Group, reviewed and recommended for approval by the JRDC and approved by the JMC. The R&D Plan will set forth (i) the scope of the ctDNA Platform Development Program and the FTE resources that will be dedicated to the activities contemplated within the scope of the ctDNA Platform Development Program, including the responsibilities of each Party (ii) an overall timeline and specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRDC as research progresses, and (iii) budgets for such activities. The Parties shall update the R&D Plan no later than [ *** ] before the first anniversary of the Effective Date. The JRDC shall review the R&D Plan on an ongoing basis and may amend the R&D Plan subject to approval of the JMC. Any such changes shall be reflected in written amendments to the R&D Plan.
3.3.4 | Responsibilities of the Parties |
FMI shall, subject to all terms and conditions of this Agreement, use Commercially Reasonable Efforts to Develop the Initial Roche ctDNA Assay and the ALK ctDNA Clinical Trial Assay in accordance with the R&D Plan. FMI will work with Roche in accordance with the R&D Plan to develop ctDNA Assays.
Roche will work with FMI in accordance with the R&D Plan, including by providing relevant Samples and associated data, in each case to the extent agreed to in the R&D Plan.
Roche assumes no liability for use of the Genomic Analyses obtained from Samples provided under this Agreement, except as and to the extent arising out of a breach by Roche of this Agreement.
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3.3.5 | Budget |
FMI will have sole control over, and responsibility for, the budget and funding for the anticipated work for the ctDNA Platform Development under the R&D Plan.
3.3.6 | Duration |
The initial term of the ctDNA Platform Development Program will be twelve (12) months.
3.3.7 | Extension |
The initial term of the ctDNA Platform Development Program may be extended by the mutual agreement of the Parties.
3.3.8 | Discount |
For the [ *** ] following commercial launch by FMI of any ctDNA Assay(s) created during or derived from the ctDNA Platform Development, Roche and its Affiliates will be entitled to [ *** ], for the purchase of any such ctDNA Assay(s).
3.3.9 | Commercialization |
Subject to the Related Agreements, FMI shall have the right to commercialize the ctDNA Assays. The ctDNA Assays may be made commercially available to any customer, except that FMI shall not disclose to an Third Party the specific content of any ctDNA Assay developed specifically for Roche for use as a Clinical Study assay.
3.4 | CDx Development Program |
3.4.1 | Scope |
Roche and FMI shall conduct the CDx Development Program pursuant to a mutually agreed R&D Plan. The activities conducted in connection with the CDx Development Program will be overseen by the JRDC. The purpose of the CDx Development Program is to develop certain companion diagnostic tests or assays (the CDx Assays ) for use in connection with certain Roche products. Such CDx Assays may include those developed at Roches request in connection with markers that have not yet been approved by the FDA for the particular tumor type/indication for which Roche is developing the relevant therapeutic ( Investigational Markers ) and those developed by mutual agreement of the Parties in connection with markers that are included in one or more assays approved by the FDA for the particular tumor type/indication to indicate use of a Roche therapeutic ( Approved Markers ).
3.4.2 | Working Group |
For each CDx Assay under development, the Parties shall establish a working group (the CDx Platform Working Group ), to operationalize the CDx Development. The Parties shall establish the first CDx Platform Working Group within sixty (60) days after the Effective Date. Each CDx Platform Working Groups activities will be overseen by JRDC.
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The CDx Platform Working Group shall serve as a forum for discussion and sharing updates and information between the Parties, but shall have no decision-making authority. The CDx Platform Working Group shall:
(i) | serve as a forum for discussing the development of CDx Assays and related Products and Services; |
(ii) | serve as a forum for coordinating the Parties efforts to carry out the R&D Plan; |
(iii) | periodically monitor progress of activities under the R&D Plan and discuss any obstacles or delays with regard to achieving the timelines set forth therein; |
(iv) | discuss the overall strategy, including the submission plans, for obtaining and maintaining Regulatory Approval of any of the Products and Services developed in the CDx Development Program; and |
(v) | such other responsibilities as may be assigned to the CDx Platform Working Group in or pursuant to this Agreement or as may be mutually agreed by the Parties in writing. |
3.4.3 | R&D Plan |
The Parties will conduct the CDx Development Program in accordance with the R&D Plan and in compliance with Performance Specifications and Quality Standards. Unless decided otherwise by the JMC, the R&D Plan will be updated [ *** ] by the CDx Platform Working Group, reviewed and recommended for approval by the JRDC and approved by the JMC. The R&D Plan will set forth (i) the scope of the CDx Development Program and the resources that will be dedicated to the activities contemplated within the CDx Development Program, including the responsibilities of each Party (ii) specific objectives for each year, which objectives will be updated or amended, as appropriate, by the JRDC as research progresses, and (iii) budgets for such activities. The Parties shall prepare a plan for activities to be conducted no later than [ *** ] before the first anniversary of the Effective Date. The JMC shall review the R&D Plan on an ongoing basis and may amend the R&D Plan. Any such changes shall be reflected in written amendments to the R&D Plan.
3.4.4 | Responsibilities of the Parties |
FMI will provide CDx development and testing services, including, as required by the R&D Plan, providing FDA QSR laboratory capacity to support such testing. The CDx services will be based on individual CDx R&D Plans for specific Roche assets that will be agreed upon, signed by the Parties and thereby made a part of this Agreement as Appendices 3.4.4(a), 3.4.4(b) and so on. All CDx services will be performed with appropriate systems and documentation to support eventual FDA approval of a PMA or 510(k) or, if agreed by the Parties, approval from the relevant regulatory authorities for an ROW Territory in which FMI will deliver a CDx Assay for Roche therapeutics.
FMI will be responsible for performing the development work for the CDx Assays according to the individual CDx R&D Plans. Unless otherwise expressly agreed between the Parties, FMI will be responsible for seeking regulatory approval (including PMAs, 510(k)s or equivalent) for the CDx Assays. FMI will provide Roche with cross-reference letters, and shall otherwise coordinate regulatory submissions and related information, with Roche.
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Roche is responsible for supplying FMI with the information and materials necessary for each CDx Assay to be developed under the CDx Development Program in accordance with the R&D Plan. Roche will be solely responsible for seeking regulatory approval for the associated Roche asset. Roche will provide FMI with cross-reference letters, and shall otherwise coordinate regulatory submissions and related information with FMI.
3.4.5 | Budget |
Roche and FMI shall agree on a budget for each CDx Assay. The initial budget forms a part of the initial R&D Plan.
3.4.6 | Duration |
The term of the CDx Development Program shall be five (5) years.
3.4.7 | Extension |
Roche shall have the right to extend the term of the CDx Development Program, upon [ *** ] prior written notice to FMI as specified in Section 19.13, for additional three (3) year periods, during any period of time in which Roche is a majority shareholder of FMI.
3.4.8 | Continuing Obligations |
If work under an individual CDx R&D Plan is initiated during the initial term of the CDx Development Program or an extension thereof, then such work shall be completed as set forth in the applicable individual CDx R&D Plan after the initial term or extension, as applicable, in accordance with the terms set forth therein and herein (including with respect to funding obligations).
3.4.9 | Commercialization |
Subject to the Related Agreements, FMI shall have the right to commercialize the CDx Assays.
3.5 | Samples, Handling and Disposal |
3.5.1 | Samples |
Roche will provide samples to FMI that meet the FMI specimen requirements attached hereto as Appendix 3.5.1 and in accordance with the applicable R&D Plan. FMI shall not transfer the Samples or other materials obtained or received in connection with this Agreement, or any derivatives thereof, to any Third Party without Roches prior written approval. FMI shall use the Samples and material obtained or received in connection with this Agreement solely for the performance of activities permitted under this Agreement in FMIs laboratories under suitable containment conditions in accordance with all Applicable Law. FMI shall not analyze the Samples other than as expressly provided for in this Agreement. FMI may use such Samples in accordance with the applicable R&D Plan without any obligation of compensation to the subjects from whom such Samples were obtained or any other Third Party for the intellectual property associated with, or any use of, such Samples.
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3.5.2 | Sample Handling and Disposal |
All Samples provided to FMI by or on behalf of Roche shall have been collected or shall be collected, handled, and transferred in compliance with Applicable Law and any applicable policies of any institutional review board, privacy board, or ethics committee with jurisdiction over the collection, handling, and transfer of such material or information. Upon termination of the Agreement or the Work Stream requiring the use of the Samples, or upon completion of those activities requiring use of the Samples, FMI shall promptly return to Roche unused or remaining Samples, or, at FMIs option, securely dispose of all unused or remaining Samples and provide Roche with a written notice of such disposal.
Roche has authorization and all consents required for FMI to use the Samples in accordance with the R&D Plans and the Agreement. FMI shall use, store and handle all Samples in accordance with the R&D Plans and all Applicable Laws. In the event of withdrawal of a subjects consent, Roche will promptly notify FMI and FMI will destroy the corresponding unused Samples (as documented by written confirmation) or return such Samples to Roche for destruction.
3.6 | Records; Reports; Audits |
3.6.1 | Progress Reports |
At least [ *** ] during the time a Work Stream remains in effect, unless otherwise agreed by the Parties, FMI shall have the obligation to prepare and provide to the JRDC a summary presentation on the progress of the work performed by FMI in the course of each Work Stream during the preceding [ *** ]. Promptly upon expiry of such Work Stream, other than the Molecular Information Platform Program, FMI shall provide a final written report summarizing its activities under such Work Stream and the results thereof.
3.6.2 | Research Records |
Each Party shall maintain records of each Work Stream (or cause such records to be maintained), except Roche shall not have such obligation for the Molecular Information Platform Program, in sufficient detail and in good scientific manner as will properly reflect all work done and results achieved by or on behalf of such Party in the performance of such Work Stream. All laboratory notebooks shall be maintained for no less than the term of any Patent Rights issuing therefrom.
In addition, during the Agreement and for [ *** ] thereafter, FMI shall maintain all data provided to FMI by Roche, the Genomic Results, the FMI Advanced Genomic Analysis Results, Database Insights Database Query Results, and documentation necessary to demonstrate FMIs compliance with the terms of this Agreement, including computerized records and files, in a secure area reasonably protected from fire, theft and destruction; provided, however , that with respect to raw genomic data, FMI shall only be required to retain the original, unprocessed BAM file generated from its sequencing process and no other raw genomic data or intermediate BAM files created in processing to generate the Results.
3.6.3 | Regulatory Inspections and Audit |
Roche shall be entitled, upon reasonable notice and during FMIs regular business hours, to visit FMIs facility (and those facilities of its subcontractors), including FMIs CLIA-compliant
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facilities, to audit for quality assurance purposes its facilities, documentation and procedures used in conducting its activities pursuant to this Agreement. Such audits may be conducted up to [ *** ] and Roche shall use reasonable effort not to disrupt ongoing operations during such audits. FMI shall provide Roche with prompt notice of any governmental or regulatory review, audit or inspection of any of its facilities involved in the development of the Molecular Information Platform, Immunotherapy Testing Platform, ctDNA Platform, or CDx Assays, and all Products and Services resulting therefrom, and FMIs CLIA-compliant facilities. FMI shall provide Roche with (a) the results of any such review, audit or inspection (including a copy of the relevant sections of the report) to the extent such results pertain to any activities under this Agreement; and (b) the opportunity to provide assistance to FMI in responding to any such review, audit or inspection.
4. | Diligence |
Roche and FMI shall use Commercially Reasonable Efforts to perform their respective activities contemplated by this Agreement.
5. | Most Favored Customer |
FMI agrees that the pricing terms for Products and Services provided by FMI to Roche herein, and services provided under the Molecular Information Platform Program, are, and will be, at least as favorable as the pricing terms granted by FMI to any existing customer or collaborator for such (or substantially similar) products or services. If FMI enters into any subsequent agreement with another customer or collaborator which provides for pricing terms for substantially the same product or services at substantially the same (or a lesser) scale, which pricing terms are more favorable than those contained herein, then FMI shall notify Roche and Roche will have the right to modify this agreement to provide Roche with those more favorable pricing terms. [ *** ].
6. | Governance |
6.1 | Joint Management Committee |
Within sixty (60) days after the Effective Date, the Parties shall establish a JMC to ensure the smooth operation of the arrangements and activities envisaged under this Agreement.
6.1.1 | Members |
The JMC shall be composed of six (6) persons ( Members ). Roche and FMI each shall be entitled to appoint three (3) Members with appropriate seniority and functional expertise. Each Party may replace any of its Members and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a Member shall notify the other Party at least ten (10) days prior to the next scheduled meeting of the JMC. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in representation. Both Parties may invite a reasonable number of additional experts and/or advisors to attend part or the whole JMC meeting with prior notification to the JMC. Members may be represented at any meeting by another person designated by the absent Member. One JMC representative from a Party shall chair ( Chairperson ) the JMC on a rotating annual calendar year basis, with the initial chairperson to be from Roche. The JMC will be made up of senior representatives from FMI and Roche, including alliance directors. The JMC may create and/or dissolve joint teams tasked with oversight of specific programs or projects, subject to overall governance by the JMC. The role of the alliance directors will be to facilitate communication and collaboration between the Parties.
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6.1.2 | Responsibilities of the JMC |
The JMC shall have the responsibility and authority to:
a) | approve the R&D Plans; |
b) | establish, disband and set expectations and mandates for JRDC, JOC, JPT and JOTs, if applicable; |
c) | oversee the JRDC, JOC, JPT and JOTs, if applicable; |
d) | provide financial oversight for the Immunotherapy Testing Platform Development Program and the CDx Development Program; and |
e) | attempt to resolve any disputes escalated from the JRDC or JOC. |
The JMC shall have no responsibility and authority other than that expressly set forth in this section.
6.1.3 | Meetings |
The Chairperson or his/her delegate is responsible for sending invitations and agendas for all JMC meetings to all Members at least ten (10) days before the next scheduled meeting of the JMC. The venue for the meetings shall be agreed by the JMC. The JMC shall hold meetings at least twice per calendar year, either in person or by tele-/video-conference, and in any case as frequently as the Members of the JMC may agree shall be necessary, but not more than four times a year. The Alliance Director of each Party may attend the JMC meetings as a permanent participant.
6.1.4 | Minutes |
The Chairperson is responsible for designating a Member to record in reasonable detail and circulate draft minutes of JMC meetings to all members of the JMC for comment and review within twenty (20) days after the relevant meeting. The Members of the JMC shall have ten (10) days to provide comments. The Party preparing the minutes shall incorporate timely received comments and distribute finalized minutes to all Members of the JMC within thirty-five (35) days of the relevant meeting. The Chairperson approves the final version of the minutes before its distribution.
6.1.5 | Decisions |
6.1.5.1 | Decision Making Authority |
The JMC shall decide matters within its responsibilities set forth in Section 6.1.2.
6.1.5.2 | ctDNA Platform |
FMI will have final decision-making rights at the JMC with respect to the ctDNA Platform Development, provided that FMI may not change the timelines agree in Section 8.4, and any change to the Roche specifications ( TPP ) for a ctDNA Assay specifically requested by Roche as part of the R&D Plan will require Roches prior approval.
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6.1.5.3 | Consensus; Good Faith |
The Members of the JMC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JMC. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.
6.1.5.4 | Failure to Reach Consensus |
If the JMC is unable to decide a matter by consensus, then the escalation procedure in Section 6.1.5.5 shall be applied.
6.1.5.5 | Escalation |
If the JMC is unable to decide a matter by consensus, then such matter shall be referred to the Chief Executive Officer of FMI or equivalent position or his/her nominee and the Chief Executive Officer of Roche or equivalent position or his/her nominee for resolution, who together shall use reasonable and good faith efforts to reach a decision by consensus within [ *** ] after the date such matter is referred to them. If the Parties still fail to reach a decision within such [ *** ]. Any such decision shall constitute a decision of the JMC. Notwithstanding the foregoing, neither Party may exercise deciding authority (i) to impose resource or financial burdens on the other Party for a Work Stream beyond the scope set forth in an agreed upon R&D Plan for such Work Stream or Reserved Capacity under the Molecular Information Platform Program, or (ii) that would violate or amend the terms of this Agreement. The JMC will exist for the Agreement Term.
6.1.6 | Information Exchange |
FMI and Roche shall exchange the information in relation to its activities under this Agreement through the JMC and FMI and Roche may ask reasonable questions in relation to the above information and offer advice in relation thereto and Roche shall give due consideration to FMIs input. The JMC may determine other routes of information exchange.
6.1.7 | Subcommittees and Joint Operational Teams |
The JMC has the right to establish sub-committees or JOTs. The JRDC shall be established within thirty (30) days after the JMC is established. The JOC shall be established as soon as the JMC deems it necessary.
6.2 | JRDC |
The JRDC shall oversee the implementation of the Work Streams and to more generally identify opportunities for value creation in research and development activities between the Parties. The JDRC shall be composed of an equal number of persons from each Party, each person having appropriate seniority and functional expertise. Each Party may replace any a person and appoint another person to fill the vacancy arising from each such replacement. The JRDC will strive to reach consensus on any matters within the committees authority with each Party having one (1) vote. Unresolved dispute at the JRDC will be escalated to the JMC.
6.2.1 | Responsibilities of the JRDC |
The JRDC shall have the responsibility and authority to:
a) | recommend the R&D Plans for approval by the JMC; |
b) | review and recommend for approval any revisions to the R&D Plans; |
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c) | review and oversee the execution of the R&D Plans; |
d) | establish timelines and criteria for decision points; |
e) | determine whether criteria have been met, including whether the criteria as to whether milestones or events have been achieved; |
f) | review the efforts of the Parties and allocate those resources for the R&D Plans (including their budgets); |
g) | identify appropriate resources necessary to conduct the R&D Plans; |
h) | oversee the progress of the Work Streams; |
j) | monitor the development costs and manage reimbursement for FMI activities under this Agreement; |
k) | determine for Products and Services Performance Specifications and identify Quality Standards applicable to respective Work Streams; and |
l) | attempt to resolve any disputes. |
The JRDC shall have no responsibility and authority other than that expressly set forth in this section.
6.3 | JOC |
The JOC shall plan and oversee the commercial, co-marketing, educational, and/or promotion activities between the Parties and to serve as a forum for communicating generally about FMIs products and strategies for global commercialization, as such activities are further described in the US Education Collaboration Agreement and the Ex-US Commercialization Agreement. The JOC shall be composed of an equal number of persons from each Party, each person having appropriate seniority and functional expertise. A description of the roles, responsibilities, and workings of the JOC are described in the Ex-US Commercialization Agreement. Through the JOC, Roche may share with FMI knowledge and experience related to countries and markets outside the United States, and will support the design and implementation of a global expansion plan for FMI products. The JOC will strive to reach consensus on any matters within the committees authority, with each Party having one (1) vote. Unresolved disputes at the JOC will be escalated to the JMC.
6.4 | Alliance Director |
Each Party shall appoint one person to be the point of contact within each Party with responsibility for facilitating communication and collaboration between the Parties (each, an Alliance Director ). The Alliance Directors shall be permanent participants of the JMC meetings (but not members of the JMC) and may attend JDRC, JOC and JOT meetings as appropriate. The Alliance Directors shall facilitate resolution of potential and pending issues and potential disputes to enable the JMC to reach consensus and avert escalation of such issues or potential disputes.
6.5 | Limitations of Authority |
No committee, working group or individual shall have the authority to amend or waive any terms of this Agreement.
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6.6 | Expenses |
Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with the JMC.
6.7 | Lifetime |
The JMC shall exist during the Agreement Term.
7. | Regulatory |
Subject to the Related Agreements, FMI, [ *** ], shall use Commercially Reasonable Efforts to pursue all regulatory affairs related to its products and services developed under this Agreement (collectively, Products and Services ) in the Territory including the preparation, filing and maintenance of applications for regulatory approval, as well as any or all governmental approvals required to develop, have developed, make, have made, use, have used, manufacture, have manufactured, import, have imported, sell and have sold such Products and Services. Subject to the Related Agreements, FMI shall be responsible for pursuing, compiling and submitting all regulatory filing documentation, and for interacting with regulatory agencies, for all Products and Services in all countries in the Territory. Subject to the Related Agreements, FMI or its Affiliates shall own and file in their discretion all regulatory filings and Regulatory Approvals for all Products and Services in all countries of the Territory. FMI shall supply Roche with a copy of all material communications related to Products and Services to or from the Regulatory Authorities. Upon request of Roche, FMI shall supply Roche with a copy of all such communications to or from the Regulatory Authorities.
Subject to the Ex-US Commercialization Agreement, FMI, [ *** ], shall report to appropriate Redulatory Authorities in accordance with local requirements all adverse events related to use of the Products and Services in the Territory.
8. | Payment |
8.1 | FTE Funding |
Roche will be responsible for funding the FTEs in accordance with the R&D Plans and budgets at the FTE Rate for performance of the research and other activities for which FMI is responsible under the R&D Plans and for the database queries. Each individual included in the funded FTEs shall possess a bachelors degree or higher in a relevant scientific discipline and shall be experienced in the type of research or other activities to be performed by such individual under this agreement.
8.2 | Molecular Information Platform Program Fees |
8.2.1 | Sample Profiling Fees |
8.2.1.1 | Reserved Capacity Fees |
In consideration for the Reserved Capacity and provision of the Sample Results associated with the Reserved Capacity, and subject to any reduction resulting from the application of Article 5, Roche shall pay to FMI an amount equal to [ *** ] for [ *** ] of the Profiling Term [ *** ] for the [ *** ] of the Profiling Term ( Reserved Capacity Fees ). The Reserved Capacity Fees are paid as follows:
[ *** ] equal installments of [ *** ] payable within [ *** ] of receipt by Roche of an invoice from FMI, beginning with receipt by Roche of a first invoice from FMI issued following the Effective Date and followed by [ *** ] additional invoices at [ *** ] intervals thereafter.
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[ *** ] equal installments of [ *** ] payable within [ *** ] of receipt by Roche of an invoice from FMI, beginning [ *** ] of the Effective Date and followed by [ *** ] additional invoices at [ *** ] intervals thereafter.
For renewal terms, the agreed upon Reserved Capacity Fee shall be paid within [ *** ] of receipt by Roche of an invoice from FMI at [ *** ] intervals.
The Reserved Capacity Fee payments shall be [ *** ] against Roches Binding Order for such period, the amount of the Reserved Capacity Fee being [ *** ]. Actual Sample Profiling costs, based on delivery of Sample Results during the [ *** ] to which the Reserved Capacity Fee applies, shall be [ *** ]. If actual Sample Profiling exceeds the amount of Sample Profiling paid by the Reserved Capacity Fees, then [ *** ]. Roche shall pay FMI for [ *** ]. If a Binding Order causes Roche to [ *** ]. Fees for Binding Orders shall [ *** ].
8.2.1.2 | Per Sample Profiling Fees |
The per Sample Profiling fees (notwithstanding the Reserved Capacity Fee) shall be as follows:
[ *** ].
8.2.2 | Molecular Information Database Access and Database Queries Fees |
For Molecular Information Database Access and performance of Database Queries by FMI, Roche will pay FMI a total of [ *** ] of the Database Term, (the Database Access Fee ), which is comprised of funding for [ *** ] FTEs, each at the FTE Rate, for performance of such Database Queries and delivery of Database Insights, and a Database Access Fee of [ *** ]. Roche shall pay to FMI the Database Access Fee [ *** ] installments of [ *** ], each payable every [ *** ] of the Database term and within [ *** ] after receipt by Roche of an invoice from FMI.
8.3 | Immunotherapy Testing Platform Development Budget and Fees |
8.3.1 | R&D Plan Budget |
Roche shall be solely responsible for Roches costs under the Immunotherapy Testing Platform Development Budget.
Roche will pay FMI [ *** ] of FMI Development Cost as agreed in the Immunotherapy Testing Platform Budget for development of the Immuno-Biomarker Discovery Platform.
Roche will pay [ *** ] of FMI Development Cost as agreed in the Immunotherapy Testing Platform Budget for Signature Identification.
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Such reimbursement of FMI Development Cost shall be paid [ *** ] in arrears. Each [ *** ], FMI shall invoice Roche for its share of FMI Development Cost incurred in the previous [ *** ]. Invoices shall be payable within [ *** ] after receipt by Roche of an invoice from FMI.
8.3.2 | Payments for Achieving Certain Immunotherapy Testing Platform Development Events |
In addition to payment of the Immunotherapy Testing Platform Development Budget as specified above, Roche shall pay FMI:
(i) | [ *** ] on Initiation of the first Roche Clinical Study utilizing a Clinical Study assay, [ *** ]. |
(ii) | [ *** ] on Initiation of the first Roche Clinical Study utilizing a Clinical Study assay, [ *** ]. |
(iii) | [ *** ] on Initiation of the first Roche Clinical Study utilizing a Clinical Study assay, [ *** ]. |
8.3.3 | Immuno Clinical Study Assays requested by Roche |
Roche will pay [ *** ] of FMIs Development Costs for development of Immuno Clinical Study Assays as may be requested by Roche, subject to an agreed upon budget for such development as provided for in Section 3.2.5.
8.3.4 | Immunotherapy CDx Assays |
If the Parties chose to develop an Immunotherapy CDx Assay, they the Parties shall agree to Roche paying certain costs and milestones for such Immunotherapy CDx assay.
8.4 | ctDNA Platform Financial Terms |
FMI will be responsible for all FMI Development Cost for the ctDNA Platform Development. As part of the agreed upon ctDNA R&D Plan, FMI will provide sample testing performed under such ctDNA R&D Plan at no cost to Roche (other than Roches cost in supplying FMI the Samples specified in the ctDNA R&D Plan).
Roche will pay FMI [ *** ] if FMI successfully [ *** ] first ctDNA Assay [ *** ] set forth in the R&D Plan ( Initial Roche ctDNA Assay ) within [ *** ] from [ *** ] (the First ctDNA Milestone Date ). Payment by Roche shall be made within [ *** ] after achieving the First ctDNA Milestone Date and the receipt by Roche of an invoice from FMI.
In addition, Roche will pay FMI [ *** ] if FMI successfully [ *** ] as agreed to in the R&D Plan; provided that [ *** ] (the Second ctDNA Milestone Date ). Payment by Roche shall be made within [ *** ] after achieving the Second ctDNA Milestone Date and the receipt by Roche of an invoice from FMI.
The Parties may develop additional ctDNA Assays for use as Clinical Study assays, subject to an agreed financial structure for such work under the R&D Plan. Such additional development work will be conducted, if at all, pursuant to an amendment to this Agreement or a separate written agreement between the Parties.
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8.5 | CDx Development Financial Terms |
8.5.1 | CDx Development Costs |
Roche shall pay FMI [ *** ] of FMI Development Cost for CDx Development of Investigational markers in compliance with the investigational CDx budget that forms part of the R&D Plan.
FMI shall pay [ *** ] of the FMI Development Cost for Approved Markers.
Such reimbursement of FMI Development Cost shall be paid [ *** ] in arrears. Each [ *** ], FMI shall invoice Roche for its share of the FMI Development Cost incurred in the [ *** ]. Invoices shall be payable within [ *** ] after receipt by Roche of an invoice from FMI.
8.5.2 | PMA Event Payments |
For each PMA approval corresponding to a Roche product, Roche shall pay FMI [ *** ], within [ *** ] after the occurrence of such event and receipt by Roche of an invoice from FMI.
8.5.3 | Commercial Success Event Payments |
Roche shall pay FMI the following milestone payments upon achievement of CDx Assay report volumes by tissue type within the first [ *** ] after [ *** ] of the associated CDx Assay as specified below:
(i) | CDx Assays Including Investigational/Approved Marker(s) for [ *** ]: |
[ *** ]. |
(ii) | CDx Assays Including Investigational/Approved Marker(s) for [ *** ]: |
[ *** ]. |
Upon achievement of each of the CDx Assay volumes under this Section 8.5.3, FMI shall timely notify Roche and payment shall be made by Roche within [ *** ] after achieving the applicable event and the receipt by Roche of an invoice from FMI.
In the event the Parties wish to develop another CDx Assay other than those specified above for [ *** ] and [ *** ] pursuant to a CDx R&D Plan, the Parties shall mutually agree to [ *** ] milestones and payments for achieving them.
8.6 | General Terms |
All rates and costs set forth herein shall remain firm for the Agreement Term and the services to be performed under each Work Stream, unless otherwise agreed to in writing, shall be at the FTE Rate. FMI has an affirmative obligation to use Commercially Reasonable Efforts to negotiate favorable terms for all FMI Development Cost that will be passed through FMI to Roche. FMI shall extend to Roche the benefit of any and all discounts and savings provided to FMI in connection with FMI Development Cost that will be passed through to Roche. Roche shall [ *** ], any amounts in excess of the agreed upon budget.
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8.7 | Disclosure of Payments |
FMI acknowledges that Roche may be obligated to disclose this financial arrangement, including all fees, payments and transfers of value, as may be advisable or required under Applicable Law, including the US Sunshine Act.
9. | Accounting and reporting |
9.1 | Timing of Payments |
Payments shall be made during the time periods set forth in this Agreement. If not stated explicitly, payments shall be made by Roche within [ *** ] after Roche receives an invoice from FMI.
9.2 | Late Payment |
Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at [ *** ] points above the average one-month Euro Interbank Offered Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days such payment is overdue.
9.3 | Method of Payment |
All amounts payable hereunder shall be paid in US dollars (the Payment Currency ) to account(s) designated by FMI.
10. | Taxes |
FMI shall pay all sales, turnover, income, revenue, value added, and other taxes levied on account of any payments accruing or made to FMI under this Agreement.
If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any royalty or other amounts payable under this Agreement to FMI, then Roche or its relevant Affiliates shall promptly pay such tax, levy or charge for and on behalf of FMI to the proper governmental authority, and shall promptly furnish FMI with receipt of payment. Roche shall be entitled to deduct any such tax, levy or charge actually paid from royalty or other payment due FMI or be promptly reimbursed by FMI if no further payments are due FMI. Each Party agrees to reasonably assist the other Party in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.
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It is understood between the Parties that the agreed upon and/or applied remunerations and other payments under this Agreement for all transactions between (a) FMI and (b) Roche are based on arms length and good faith considerations. Should such remunerations for products and services or other payments nevertheless be challenged by any Governmental Authority including any tax authority in the US, or in Switzerland or other jurisdiction of Roche or its relevant Affiliates ( Roches Jurisdiction ):
(a) | FMI and Roche or its relevant Affiliates shall fully co-operate with each other with the objective to convince the challenging authority that such remunerations for products and services and other payments are appropriate, including providing each other with copies of third party agreements if necessary to utilize as comparables to support the arms length nature of transactions between FMI and Roche. In the event that the challenging authority is not convinced, the Parties shall request that the tax authorities in the US and in Roches Jurisdiction initiate government-to-government procedures pursuant to the applicable bi-lateral convention for the avoidance of double taxation or similar treaty or convention (if any) between the US and Roches Jurisdiction ( Competent Authority Procedures ). |
(b) | In the event that the US tax authorities determine that such remunerations for products and services or other payments are not appropriate and levy an assessment on FMI, and such assessment results in a refund (or similar payment or credit) by or from the tax authorities in Roches Jurisdiction to Roche or its relevant Affiliate, then Roche shall pay (or shall ensure that Roche shall pay) the amount of such refund to FMI. In the event that the tax authorities in Roches Jurisdiction determine that such remunerations for products and services or other payments are not appropriate and levy an assessment on Roche, and such assessment results in a refund (or similar payment or credit) by or from the US tax authorities to FMI then FMI shall pay (or shall ensure that FMI shall pay) the amount of such refund to Roche. Each Party shall use its reasonable efforts to obtain such refund (or similar payment or credit). |
(c) | In the event of such an assessment by either tax authority (an Assessment ), the Parties agree to making adjustments to the relevant remunerations for products and services or other payments to levels agreed to by the tax authorities in both the US and Roches Jurisdiction as the result of Competent Authority Procedures. |
11. | Auditing |
11.1 | Right to Audit |
Each Party shall keep, and shall require its Affiliates and Sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all payments payable under this Agreement, including, for Roche, the right to audit materials necessary to ensure compliance with the most favored customer provisions of Article 5. Such books of accounts shall be kept at their principal place of business. At the expense of the auditing Party, the auditing Party shall have the right to engage an internationally recognized, independent public accountant reasonably accept able to the other Party to perform, on behalf of such Party an audit of such books and records of the audited Party and its Affiliates, its licensees and Sublicensees, that are deemed necessary for the period or periods requested by the auditing Party and the correctness of any financial report or payments made under this Agreement, including with respect to benefits and terms complying with the most favored
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customer provisions of Article 5. For avoidance of doubt, all audits under this Section shall be conducted solely by an independent public accountant as described in the foregoing sentence.
Upon timely request and at least [ *** ] prior written notice from the auditing Party, such audit shall be conducted in the countries specifically requested by the auditing Party, during regular business hours in such a manner as to not unnecessarily interfere with the audited Partys normal business activities, and shall be limited to results in the [ *** ] prior to audit notification.
Such audit shall not be performed more frequently than [ *** ] nor more frequently than [ *** ] with respect to records covering, or impacting in accordance with Article 5, any specific period of time.
All information, data documents and abstracts herein referred to shall be used only for the purpose of verifying payment obligations, shall be treated as the audited Partys Confidential Information subject to the obligations of this Agreement and need neither be retained more than [ *** ] after completion of an audit hereof, if an audit has been requested; nor more than [ *** ] from the end of the [ *** ] to which each shall pertain; nor more than [ *** ] after the date of termination of this Agreement.
11.2 | Audit Reports |
The auditors shall only state factual findings in the audit reports and shall not interpret the agreement. The auditors shall share all draft audit reports with the auditing Party before the draft report is shared with the audited Party and before the final document is issued. The final audit report shall be shared with the auditing Party at the same time it is shared with the audited Party.
11.3 | Over or Underpayment |
If the audit reveals an overpayment by Roche, FMI shall reimburse Roche for the amount of the overpayment within [ *** ]. If the audit reveals an underpayment by Roche, Roche shall make up such underpayment with the next payment or, if no further payments are owed by Roche, Roche shall reimburse FMI for the amount of the underpayment within [ *** ]. The audited Party shall pay for the audit costs if the underpayment of the audited Party exceeds [ *** ] of the aggregate amount of royalty payments owed with regard to the period subject of the audit. Section 9.2 shall apply to this Section 11.3.
11.4 | Duration of Audit Rights |
The failure of a Party to request verification of any calculation within the period during which corresponding records must be maintained under this Article 11 will be deemed to be acceptance of the payments and reports.
12. | Intellectual Property |
12.1 | Ownership of Inventions, data and results |
12.1.1 | In General |
Except as specifically set forth herein, FMI shall own all FMI Inventions, Roche shall own all Roche Inventions, and FMI and Roche shall jointly own all Joint Inventions. FMI and Roche each shall require all of its employees to assign all inventions related to Products and Services made by them to Roche and FMI, as the case may be.
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The determination of ownership of Inventions shall be determined in accordance with US inventorship laws as if such Inventions were made in the US.
Except as otherwise expressly set forth herein, each Party shall retain full ownership and control of, and all rights in, its Background IP and any improvements or modifications thereto ( Roche Improvement IP and FMI Improvement IP respectively). Roche Improvement IP shall mean any improvements or modifications to Roches Background IP discovered, conceived or reduced to practice after the Effective Date in the performance of activities under this Agreement. FMI Improvement IP shall mean any improvements or modifications to FMIs Background IP discovered, conceived or reduced to practice after the Effective Date in the performance of activities under this Agreement. All materials, information, data and writings provided to FMI by or on behalf of Roche, in any form whatsoever, which were Controlled by Roche prior to being provided to FMI, shall remain the property of Roche; FMI shall acquire no right, title or interest in such materials, information, data and writings as the result of its activities under this Agreement.
Except as specifically set forth herein, this Agreement shall not be construed, by implication, necessity or otherwise as (i) giving any of the Parties any license, right, title, interest in or ownership to the Confidential Information; (ii) granting any license or right under any intellectual property rights; or (iii) representing any commitment by either Party to enter into any additional agreement.
12.1.2 | For the Molecular Information Platform Program |
Subject to the license granted to FMI under Section 2.1.2, Roche shall exclusively own all right title and interest to any information, results, and intellectual property from any Clinical Study undertaken or supported by Roche, including, without limitation, the Sample Results and information and results from any Sample Profiling. FMI shall assign to Roche its rights to any intellectual property in or arising from the Sample Results (except for FMI Improvements).
Except as otherwise set forth herein, FMI shall exclusively own all right, title, and interest to any improvements or modifications to the FMI Genomic Analysis Platform that arise in connection with the performance of the work under the Molecular Information Platform Program.
Roche shall exclusively own all information, results, and intellectual property from Advanced Genomic Analyses performed on Roche samples ( Roche-Owned Advanced Genomic Analysis Results ), and any inventions arising from the Roche-Owned Advanced Genomic Analysis Results, and FMI will assign all rights to any such inventions to Roche (except for FMI Improvements).
12.1.3 | For the Immunotherapy Testing Platform Program |
Subject to the license granted to FMI under Section 2.1.3, Roche shall exclusively own all data, results, and intellectual property therein arising from profiling samples provided by Roche to FMI for testing in the Immunotherapy Testing Platform Development (except for FMI Improvements) ( Roche Immunotherapy Sample Results ), and FMI shall assign to Roche all such intellectual property. FMI shall not disclose Roche Immunotherapy Sample Results to third parties or use such results in work with Third Parties.
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Roche shall exclusively own, and FMI shall assign to Roche, all intellectual property arising from the Immunotherapy Testing Platform Development that Covers methods of treatment, stratifying patients, or identifying patients that would benefit from a particular treatment, and all other methods useful in connection with the therapeutic treatment of a patient.
To the extent third-party intellectual property must be licensed for the Immunotherapy Testing Platform Development, Roche and FMI shall jointly decide on an appropriate in-licensing strategy and negotiate a fair cost sharing between the Parties in good faith; provided however, that FMI shall retain the right to take such a license at its own cost on such terms as it shall determine if the Parties cannot reach a timely agreement on how to proceed.
12.1.4 | For the ctDNA Program |
Subject to the license granted to FMI under Section 2.1.4, Roche shall exclusively own all data, results, and intellectual property arising from the profiling of Roche samples in the ctDNA Platform Development Program ( Roche ctDNA Sample Results ). FMI shall not disclose Roche ctDNA Sample Results to third parties or use such results in work with third parties.
12.1.5 | For the CDx Development Program |
Subject to the license granted to Roche under Section 2.1.5, FMI shall exclusively own all intellectual property arising from the CDx Development that Covers the CDx Assays ( FMI CDx IP ).
Roche shall exclusively own all data, results, and intellectual property arising from analysis of its samples in the relevant CDx Development as well as all intellectual property arising from the CDx Development Program to the extent that it is reasonably related to or Covers the relevant Roche product including the use, formulation, and methods of treatment for the relevant Roche product ( Roche CDx Development IP ).
To the extent third-party intellectual property must be licensed for the Investigational CDx Development or commercialization of the Investigational CDx Assays, Roche and FMI shall jointly decide on an appropriate in-licensing strategy and negotiate a fair cost sharing between the Parties in good faith.
12.2 | German Statute on Employees Inventions |
In accordance with the German Statute on Employees Inventions, each Party agrees to claim the unlimited use of any Invention conceived, reduced to practice, developed, made or created in the performance of, or as a result of, any Research Program by employees of any German Affiliates or any other persons acting on behalf of such German Affiliates. For the avoidance of doubt, each Party is responsible for fulfilling the obligations towards their employees under the German Statute of Employees Inventions.
12.3 | Prosecution and Maintenance of Patent Rights Claiming FMI Inventions |
FMI shall, at its own expense and discretion, (i) control and Handle all FMI Foreground Patent Rights, (ii) consult with Roche as to the Handling of such FMI Foreground Patent Rights, and (iii) furnish to Roche copies of all material documents relevant to any such Handling. FMI shall furnish such documents and consult with Roche in sufficient time before any action by FMI is due to allow Roche to provide comments thereon, which comments FMI must consider. At FMIs
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expense and reasonable request, Roche shall cooperate, in all reasonable ways with the Handling of all FMI Foreground Patent Rights. If FMI elects not to Handle any FMI Foreground Patent Rights under this Section 12.3, then FMI shall provide at least [ *** ] prior written notice to Roche. Thereafter, Roche shall have the right, but not the obligation to Handle any such notified FMI Foreground Patent Rights, at its sole expense and its sole discretion. Notwithstanding the foregoing, and for clarity, FMI shall have no obligations to Roche under this Section 12.3 in regard to FMI Foreground Patent Rights relating to the Genomic Analysis Platform or the Molecular Information Database (including, without limitation, methods, procedures, and algorithms related to or embodied in each) that do not incorporate or rely on the continued use of Roche Confidential Information.
12.4 | Prosecution and Maintenance of Roche Foreground Patent Rights and Joint Patent Rights |
Roche shall, at its own expense and discretion, control and Handle (including abandon) all Roche Foreground Patent Rights and Joint Patent Rights. If Roche elects not to Handle any Patent Rights under this Section 12.4, then Roche shall provide at least [ *** ] prior written notice to FMI. Thereafter, FMI shall have the right, but not the obligation to Handle any such notified Patent Rights, at its sole expense and its sole discretion.
12.5 | Joint Patent Team |
Where the Parties need to consult with each other on the Handling of Patent Rights, the Parties shall establish a joint patent team ( JPT ) and shall adopt procedures for interacting on patent matters. The JPT shall be subject to the oversight of the JMC. The JPT shall also serve as a forum for promptly notifying the other Party when an Invention is made by a Party.
12.6 | CREATE Act |
It is the intention of the Parties that this Agreement is a joint research agreement as that phrase is defined in Public Law 108-53 ( Create Act ) and applied in 35 USC §103(c)(3). If either Party intends to overcome a rejection of a claimed invention within the FMI Foreground Patent Rights or Roche Foreground Patent Rights pursuant to the provisions of the Create Act, then the Parties, through the JPT, shall work together in good faith to agree in writing how any rejection should be overcome.
12.7 | Infringement |
Each Party shall promptly provide written notice to the other Party during the Agreement Term of any (i) known infringement or suspected infringement by a Third Party of any FMI Background Patent Rights, FMI Foreground Patent Rights, Roche Background Patent Rights, Roche Foreground Patent Rights or Joint Patent Rights, or (ii) known or suspected unauthorized use or misappropriation by a Third Party of any FMI Background Know-How, FMI Know-How, Roche Background Know-How, Roche Know-How or Joint Know-How, and shall provide the other Party with all evidence in its possession supporting such infringement or unauthorized use or misappropriation.
Within [ *** ] after a Party provides or receives such written notice ( Decision Period ), the Party Handling enforcement of such Patent Right as set forth in this Section 2.7, in its sole discretion, shall decide whether or not to initiate such suit or action in the Territory and shall notify the other Party in writing of its decision in writing ( Suit Notice ).
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For any FMI Background Patent Right or sole FMI Patent Right, FMI in its sole discretion shall decide whether or not to initiate such suit or action in the Territory. FMI shall have full discretion as to how it wishes to handle such suit and may reach Settlement under any terms and conditions it desires and retain all damages, settlement fees or other consideration received in connection therewith. Only if a Settlement could adversely affect Roche shall the written consent of Roche be required, which consent shall not be unreasonably withheld. The term adversely affect in the previous sentence shall include, among other things, [ *** ].
For any sole Roche Background Patent Right or Roche Patent Right, Roche, in its sole discretion, shall decide whether or not to initiate such suit or action in the Territory. Roche shall have full discretion as to how it wishes to handle such suit and may reach Settlement under any terms and conditions it desires and retain all damages, settlement fees or other consideration received in connection therewith. Only if a Settlement could adversely affect FMI shall the written consent of FMI be required, which consent shall not be unreasonably withheld.
If for a Joint Patent Right, Roche decides to bring a suit or take action, once Roche provides Suit Notice, Roche may immediately commence such suit or take such action. In the event that Roche (i) does not in writing advise FMI within the Decision Period that Roche will commence suit or take action, or (ii) fails to commence suit or take action within a reasonable time after providing Suit Notice, FMI shall thereafter have the right to commence suit or take action in the Territory and shall provide written notice Roche of any such suit commenced or action taken by FMI.
Upon written request, the Party bringing suit or taking action ( Initiating Party ) shall keep the other Party informed of the status of any such suit or action and shall provide the other Party with copies, to the extent the Initiating Party is lawfully permitted to do so, of all material documents or communications filed in such suit or action. The Initiating Party shall have the sole and exclusive right to select counsel for any such suit or action.
The Initiating Party shall, except as provided below, pay all expenses of the suit or action, including the Initiating Partys attorneys fees and court costs. Any damages, settlement fees or other consideration received as a result of such suit or action shall be allocated as follows:
(a) | First, to reimburse the Initiating Party for its costs and, if any remains, to the other Party for any advisory counsel fees and costs; and |
(b) | Second, the balance, if any, shall be allocated [ *** ]. |
If the Initiating Party believes it is reasonably necessary or desirable to obtain an effective remedy, upon written request the other Party agrees to be joined as a party to the suit or action but shall be under no obligation to participate except to the extent that such participation is required as the result of its being a named party to the suit or action. At the Initiating Partys written request, the other Party shall offer reasonable assistance to the Initiating Party in connection therewith at no charge to the Initiating Party except for reimbursement of reasonable out-of-pocket expenses incurred by the other Party in rendering such assistance. The other Party shall have the right to participate and be represented in any such suit or action by its own counsel at its own expense.
The Initiating Party may settle, consent judgment or otherwise voluntarily dispose of the suit or action ( Settlement ) without the written consent of the other Party but only if such Settlement can be achieved without adversely affecting the other Party (including any of its Patent Rights). If a Settlement could adversely affect the other Party, then the written consent of the other Party would be required, which consent shall not be unreasonably withheld.
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12.8 | Defense |
If an action for infringement is commenced against either Party, its licensees or its sublicensees related to such Partys conduct of a Work Stream within the scope of an R&D Plan then such Party shall defend such action at its own expense, and the other Party shall assist and cooperate with such Party, at its own expense, to the extent necessary in the defense of such suit. The defending Party shall have the right to settle the suit or consent to an adverse judgment thereto, in its sole discretion, so long as such settlement or adverse judgment does not adversely affect the rights of the other Party and its Affiliates (including any patent rights Controlled by any of them). The defending Party shall assume full responsibility for the payment of any award for damages, or any amount due pursuant to any settlement entered into by it with such Third Party.
If the manufacture, use, importation, offer for sale or sale of any Products and Services results in any claim, suit or proceeding alleging patent infringement or trade secret misappropriation against FMI or a member of the Roche Group, then such Party shall promptly notify the other Party hereto. The Parties shall cooperate with each other in connection with any such claim, suit or proceeding and shall keep each other reasonably informed of all material developments in connection with any such claim, suit or proceeding.
If a Third Party asserts that Patent Rights owned by or licensed to it are infringed by the development, manufacture, use, importation, offer for sale or sale of products arising out of this Agreement by a member of the Roche Group, or that its trade secrets were misappropriated in connection with such activity, then Roche shall have the exclusive right and responsibility to resolve any such claim, whether by obtaining a license from such Third Party, by defending against such Third Partys claims or otherwise, and shall be solely responsible for the defense of any such action, any and all costs incurred in connection with such action (including, without limitation, attorneys and expert fees) and all liabilities incurred in connection therewith. Notwithstanding the above, Roche shall not enter into any settlement of any such claim without the prior written consent of FMI if such settlement would require FMI to be subject to an injunction or to make any monetary payment to Roche or any Third Party, or admit any wrongful conduct by FMI or its Affiliates, or would limit or restrict the claims of or admit any invalidity and/or unenforceability of any of the Patent Rights Controlled by FMI, or have any impact on activities outside the Field.
12.9 | Common Interest Disclosures |
With regard to any information or opinions disclosed pursuant to this Agreement by one Party to each other regarding intellectual property and/or technology owned by Third Parties, the Parties agree that they have a common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the conduct of the Work Streams and/or Products and Services, and have a further common legal interest in defending against any actual or prospective Third Party claims based on allegations of misuse or infringement of intellectual property rights relating to the conduct of the Work Streams and/or Products and Services. Accordingly, the Parties agree that all such information and materials obtained by FMI and Roche from each other will be used solely for purposes of the Parties common legal interests with respect to the conduct of the Agreement. All information and materials will be treated as protected by the attorney-client privilege, the work product privilege, and any other privilege or
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immunity that may otherwise be applicable. By sharing any such information and materials, neither Party intends to waive or limit any privilege or immunity that may apply to the shared information and materials. Neither Party shall have the authority to waive any privilege or immunity on behalf of the other Party without such other Partys prior written consent, nor shall the waiver of privilege or immunity resulting from the conduct of one Party be deemed to apply against any other Party.
13. | Representations and Warranties |
13.1 | Mutual Representations and Warranties |
FMI and Roche each represent and warrant that:
(a) it has all requisite power and authority to enter into and perform its obligations under this Agreement;
(b) it has no outstanding agreement or obligation that is in conflict with any of the provisions of this Agreement or that would preclude its personnel from complying with the provisions hereof;
(c) all of its employees, officers and consultants have executed agreements requiring assignment to it of all Inventions made by such individuals during the course of and as a result of their participation in activities under this Agreement;
(d) the execution, delivery and performance of this Agreement by it and all instruments and documents to be delivered by it hereunder: (i) are within its corporate power; (ii) have been duly authorized by all necessary or proper corporate action; (iii) are not in contravention of any provision of any of its formation or governing documents; (iv) to its knowledge, will not violate any law or regulation or any order or decree of any court of governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which it is a party or by which it or any of its property is bound, which violation would have an adverse effect on its financial condition or on its ability to perform its obligations hereunder; and (vi) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products);
(e) there are no claims or investigations (other than with respect to the Parties HSR filings), pending or threatened against it or any of its Affiliates, at law or in equity, or before or by any governmental authority relating to the matters contemplated under this Agreement or that would materially adversely affect its ability to perform its obligations hereunder; and
(f) neither it nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of its obligations hereunder.
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13.2 | Activities |
Each Party will perform all activities under this Agreement (i) in a professional manner, (ii) in conformance with the level or care and skill ordinarily exercised by other professional institutions in similar circumstances, and (iii) in compliance with Applicable Law.
13.3 | Safety Data |
FMI represents and warrants that FMI has disclosed to Roche and will immediately continue to disclose to Roche any relevant safety data relevant to the Work Streams and assays being developed thereunder.
13.4 | Third Party Patent Rights |
FMI represents and warrants that FMI has no knowledge of the existence of any patent or patent application owned by or licensed to any Third Party that could prevent in the Territory the activities contemplated under this Agreement.
13.5 | Inventors |
FMI represents and warrants that FMI has obtained the assignment of, or a license under, the FMI Background Patent Rights necessary to grant the licenses granted hereunder. FMI shall obtain the assignment of, or a license under, the FMI Foreground Patent Rights necessary to grant the licenses granted hereunder.
13.6 | Grants |
FMI represents and warrants that, to the best of FMIs knowledge and belief, FMI has the lawful right to grant Roche and its Affiliates the rights and licenses described in this Agreement.
13.7 | Ownership and Validity of Know-How |
FMI represents and warrants that FMIs Know-How is legitimately in the possession of FMI and has not been misappropriated from any Third Party. FMI has taken reasonable measures to protect the confidentiality of its Know-How.
13.8 | Data Protection (Privacy) and Security. |
13.8.1 | Study Data Collection |
FMI shall collect and process Study Data in accordance with the provisions of this Agreement and in compliance with Applicable Law with respect to the processing of Study Data, including but not limited to applicable international, US federal, state and local data protection and data security laws.
13.8.2 | Data Protection |
To ensure the privacy and security of the health or medical data, including Study Data or other Personal Data related to this Agreement that FMI shall create, acquire, receive, maintain, or transmit as a result of entering into the Agreement, FMI shall implement adequate and reasonable safeguards to prevent the use or disclosure of such information other than as provided for in the Agreement, and to protect the confidentiality, integrity, and availability of such information. In addition, FMI shall protect all such data, in accordance with applicable international Data Protection laws and US federal and state laws and regulations.
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13.8.3 | Privacy |
FMI understands and agrees that the confidentiality, privacy and security requirements contained in this Agreement also apply to any permitted sub-contractors, temporary employees or other third-parties who receive any health or medical data, including Study Data, or other Personal Data, as a result of this Agreement. FMI will ensure that all of these parties enter substantially similar confidentiality, privacy and security agreements with Institution. Copies of such Agreements shall be provided to Roche within seven (7) business days upon written request of Roche.
13.8.4 | Training |
FMI shall also ensure that its own employees, as well as any permitted subcontractors, temporary employees or other Third Parties who assist FMI in performing activities under the Agreement, and who have access to any health or medical data, including Study Data or other Personal Data, as a result of this Agreement receive appropriate privacy and security training, which shall be updated periodically in accordance with applicable laws, regulations, and industry standard, or as otherwise reasonably requested by Roche.
13.8.5 | Processing of Study Data |
FMI, its Affiliates and agents shall not collect or process health or medical data, including Study Data or any other Personal Data related to this Agreement, in a manner that involves the transfer of such Personal Data from one jurisdiction to any other jurisdiction (the EEA constituting a single jurisdiction for this purpose), without prior written consent of Roche.
13.8.6 | Compliance |
FMI undertakes to comply with its obligations (if any) under applicable legislation to notify any supervisory authority of its collection and processing activities under this Agreement and further agrees to take all such steps as Roche may reasonably require from time to time in order to enable Roche to comply with any notification obligation applicable to Roche.
13.8.7 | Data Collection |
FMI will ensure that it does not collect any health or medical data, including Study Data, relating to individuals other than the categories of data specified in the protocol identified in the applicable Task Order and will collect and process Study Data for the sole purpose of the study identified in the applicable Task Order and not further process such data in any other manner.
13.8.8 | Disclosure |
FMI will not disclose health or medical data, including Study Data or any other Personal Data related to this Agreement to any Third Party outside of the requirements of this Agreement without the prior permission in writing of Roche, except where such disclosure is required by any applicable law, regulation or supervisory authority, in which case the Institution will, wherever possible, notify Roche prior to complying with any such request for disclosure and shall comply with all reasonable directions of Roche with respect to such disclosure.
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13.8.9 | Document Retention |
FMI will have appropriate procedures in place for the destruction or purging of any medical or health data, including Study Data and any other Personal Data, related to this Agreement when the retention time that applies to the data has been reached.
13.8.10 | Procedures |
FMI shall ensure that it has appropriate procedures in place to fulfill applicable International Data Protection laws and US federal and state or other legal requirements, should an individual request access to or changes to the health or medical data, including Study Data or any Personal Data related to this Agreement, maintained by Institution. Institution will notify Roche promptly (and in any event within [ *** ] after receipt) of any communication received from a Data Subject relating to the Data Subject a right to access, modify or correct Study Data and to comply with all instructions of Roche in responding to such communications.
13.8.11 | Survival |
FMIs obligations to maintain privacy and security over medical or health data, including Study Data and other Personal Data received pursuant to this Agreement, will survive the termination or expiration of this Agreement.
13.8.12 | Security Breach |
At any time during the processing of Persona Data, FMI shall notify Roche immediately (but no later than [ *** ] from the date) of any Data Security Breach involving Roche data. FMI shall assist and cooperate with Roche concerning any disclosures to affected parties, government or regulatory agencies and with any other remedial measures requested by Roche or mandated by Applicable Law.
13.9 | No Other Representations |
EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT AND THE RELATED AGREEMENTS BEING ENTERED INTO BY THE PARTIES AT THIS TIME, THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS. IN NO EVENT SHALL EITHER FMI OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY.
14. | Indemnification |
14.1 | Indemnification by Roche |
Roche shall indemnify, hold harmless and defend FMI and its directors, officers, employees and agents from and against any and all losses, expenses, cost of defense (including without
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limitation attorneys fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts FMI becomes legally obligated to pay because of any claim or claims against it to the extent that such claim or claims arise out of Roches and its Affiliates actions or inactions in connection with activities under this Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of FMI.
14.2 | Indemnification by FMI |
FMI shall indemnify, hold harmless and defend Roche and its directors, officers, employees and agents from and against any and all losses, expenses, cost of defense (including without limitation attorneys fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Roche becomes legally obligated to pay because of any claim or claims against it to the extent that such claim or claims arise out of FMIs and FMIs Affiliates actions or inactions in connection with activities under this Agreement, except to the extent that such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of Roche.
14.3 | Procedure |
In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement ( Indemnified Party ), the Indemnified Party shall promptly notify the other Party ( Indemnifying Party ) in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Partys written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.
15. | Liability |
THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY SET FORTH HEREIN. FMI AND ROCHE DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS.
16. | Obligation Not to Disclose Confidential Information |
16.1 | Non-Use and Non-Disclosure |
During the Agreement Term and for [ *** ] thereafter, a Receiving Party shall (i) treat Confidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information
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to Third Parties, without the Disclosing Partys prior written consent, and (iii) not use such Confidential Information other than for fulfilling its obligations or exercising its rights under this Agreement. If any Confidential Information is required to be disclosed by the Receiving Party or its Affiliates to comply with a court or administrative order, the Receiving Party or its Affiliates, prior to making such disclosure, shall furnish as much notice as is reasonable under the circumstances to the Disclosing Party to enable it to resist such disclosure.
16.2 | Permitted Disclosure |
Notwithstanding the obligation of non-use and non-disclosure set forth in Section 16.1, the Parties recognize the need for certain exceptions to this obligation, specifically set forth below, with respect to press releases, patent rights, publications, and certain commercial considerations.
16.3 | Press Releases |
Following the Effective Date, the Parties will issue a joint press release announcing the existence and selected key terms of this Agreement, in a form substantially similar to the template attached as Appendix 16.3.
Each Party shall provide the other with a copy of any draft press release related to the activities contemplated by this Agreement at least ten (10) Business Days prior to its intended publication for such other Partys review. The reviewing Party may provide the releasing Party with suggested modification to the draft press release. The releasing Party shall consider, and shall not unreasonably disregard, the reviewing Partys suggestions in issuing its press release. Notwithstanding the foregoing, each Party must comply with its obligations under Section 16.1 and 16.5.
16.4 | Publications |
During the Agreement Term, the following restrictions shall apply with respect to disclosure by any Party of Confidential Information in any publication or presentation. A Party ( Publishing Party ) shall provide the other Party with a copy of any proposed publication or presentation at least [ *** ] prior to submission for publication so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain the Confidential Information disclosed by the other Party to the Publishing Party in accordance with the requirements of this Agreement. The incorporation of such recommended changes shall not be unreasonably refused; and if such other Party notifies ( Publishing Notice ) the Publishing Party in writing, within [ *** ] after receipt of the copy of the proposed publication or presentation, that such publication or presentation in its reasonable judgment (i) contains an invention, solely or jointly conceived and/or reduced to practice by the other Party, for which the other Party reasonably desires to obtain patent protection or (ii) could be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by the other Party to the Publishing Party, the Publishing Party shall prevent such publication or delay such publication for a mutually agreeable period of time. In the case of inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on such invention, and in no event less than [ *** ] from the date of the Publishing Notice.
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16.5 | Commercial Considerations |
Nothing in this Agreement shall prevent a Party or its Affiliates from disclosing Confidential Information of the other Party to (i) governmental agencies to the extent required or desirable to secure government approval for the development, manufacture or sale of a product in the Territory and (ii) Third Parties acting on behalf of a Party, to the extent reasonably necessary to conduct the activities contemplated by this Agreement provided that such Third Parties are bound by confidentiality obligations with respect to such information that are no less stringent than those included in this Agreement.
17. | Term and Termination |
17.1 | Commencement and Term |
This Agreement shall commence upon the Effective Date and continue for the Agreement Term.
17.2 | Termination |
17.2.1 | Termination for Breach |
A Party ( Non-Breaching Party ) shall have the right to terminate this Agreement on a Work Stream-by-Work Stream basis, or, for Roche, on an Approved Marker or Investigational Marker basis in the case of the CDx Development Program, in the event the other Party ( Breaching Party ) is in material breach of any of its material obligations under the applicable Work Stream (or obligations pertaining to an Approved Marker or Investigational Marker program). Failure of FMI to comply materially with Performance Specifications or Quality Standards shall be considered a material breach by FMI. For avoidance of doubt, a Non-Breaching Party shall only be permitted to terminate the Work Stream (or Approved Marker or Investigational Marker program) to which a material breach of a material obligation relates. The Non-Breaching Party shall provide written notice to the Breaching Party, which notice shall identify the breach. Except in the event of a breach that, by its nature, is not amenable to cure, in which case termination may be made effective immediately, the Breaching Party shall have a period of [ *** ] after such written notice is provided ( Peremptory Notice Period ) to cure such breach or, absent withdrawal of the Non-Breaching Partys request for termination, the relevant Work Stream (or Approved Marker or Investigational Marker program) shall terminate; provided that, if the Breaching Party has a bona fide dispute as to whether such breach: (i) occurred, (ii) pertains to a material obligation, or (iii) has been cured, the Breaching Party will so notify the Non-Breaching Party, the relevant Work Stream (or Approved Marker or Investigational Marker program) shall not terminate and the expiration of the Peremptory Notice Period shall be tolled until such dispute is resolved pursuant to Section 19.2. If such dispute is resolved by finding that the Non-Breaching Party is entitled to terminate the relevant Work Stream (or Approved Marker or Investigational Marker program), the Breaching Party may have the remainder of the Peremptory Notice Period to cure such breach. If such breach is not cured within the Peremptory Notice Period, then absent withdrawal of the Non-Breaching Partys request for termination, the relevant Work Stream (or Approved Marker or Investigational Marker program) shall terminate in accordance with the notice from the Non-Breaching Party as of the expiration of the Peremptory Notice Period.
17.2.2 | Insolvency |
A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to
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terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within [ *** ] after the filing thereof.
17.2.3 | Termination by Roche without Cause |
Roche shall have the right to terminate the Agreement in its entirety, or on a Work Stream-by-Work Stream basis, except for the ctDNA Work Stream, upon [ *** ] prior written notice, without cause. With regard to the CDx Development Program, Roche shall also have the right to terminate, without cause, the development of an Approved Marker and/or an Investigational Marker for inclusion in a CDx Assay, upon [ *** ] prior written notice; provided however that this right shall expire with respect to each Approved Marker for inclusion in a particular CDx Assay at such time as FMI has completed analytical validation for such Approved Marker. With regard to the Molecular Information Platform Program, Roche shall have the right to terminate without cause either or both of the Sample Profiling or Molecular Information Database Access activities individually.
17.2.4 | Termination by Roche for Frustration of Purpose |
Roche shall have the right to terminate the ctDNA Platform Development Program upon [ *** ] prior written notice for frustration of purpose in the event that the Clinical Study for which the ctDNA Assay is being developed is canceled.
17.3 | Consequences of Termination |
17.3.1 | Termination in General |
Upon any termination of the Agreement, a Work Stream (or Approved Marker or Investigational Marker program), or this Agreement under Section 17.2.2, (i) FMI shall promptly return to Roche unused or remaining Samples that were provided for use in a terminated Work Stream (or related to the relevant Approved Marker or Investigational Marker), or, at Roches option, securely dispose of all such unused or remaining Samples and provide Roche with a written notice of such disposal, (ii) each Party shall wind-down their activities under the Agreement in a manner that is intended to be expeditious and to mitigate losses arising from non-cancellable expenses and financial commitments to Third Parties, (iii) upon any termination by Roche under Section 17.2.3, or by FMI under Section 17.2.1 or Section 17.2.2, that includes the Immunotherapy Testing Platform Development Work Stream, the obligations in Section 3.2.8 shall terminate, (iv) each Party shall continue to Control its own intellectual property, including Patent Rights and Know-How, and Handle its own Patent Rights, and (v) Joint Patent Rights, if any, shall be handled by Roche subject to the provisions of Section 12.4 and 12.6, and each Party shall have the right to fully exploit such Joint Patent Rights.
17.3.2 Termination by FMI for Breach by Roche or Roches Insolvency; Termination by Roche Without Cause or for Frustration of Purpose
Upon any termination by FMI for breach by Roche under Section 17.2.1, for Roches Insolvency under Section 17.2.2, by Roche without cause under Section 17.2.3, or by Roche for frustration of purpose under Section 17.2.4:
(i) | The rights and licenses granted by FMI to Roche hereunder shall terminate for the terminated Agreement, or Work Stream, or portion of the Work Stream (as applicable, the Terminated Matter ), on the effective date of termination; |
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(ii) | All licenses granted by Roche to FMI hereunder pertaining to the Terminated Matter become fully paid up, perpetual and irrevocable; |
(iii) | Roche shall retain all licenses granted by FMI to Roche pertaining to intellectual property arising from work on the Terminated Matter prior to termination, provided, however, FMI shall be under no obligation to Handle any patent or patent application arising from Terminated Matters and may freely abandon (without offering Roche the right to Handle) or license (but, for clarity, not exclusively license or assign without Roches consent if Roche retains license rights) such patent or patent application. |
(iv) | Within [ *** ] after the effective date of termination and receipt by Roche of an invoice from FMI, Roche shall pay to FMI the following amounts: |
a. | In the event of termination of the Molecular Information Platform Program Work Stream, Roche shall pay FMI all [ *** ] that would be owed over the remainder of the Agreement Term, or any [ *** ], plus any applicable incremental per Sample Profiling Fees for Sample Profiling performed by FMI during the year in which termination occurs that are [ *** ]; |
b. | In the event of termination of the Immunotherapy Testing Platform Development Work Stream, (1) for avoidance of doubt, Roche shall pay FMI Roches share of any FMI Development Costs incurred in connection with the Immunotherapy Testing Platform Development Work Stream as of the effective date of termination that were not previously paid by Roche; (2) (A) if the effective date of termination occurs prior to FMIs completion of the Immuno-Biomarker Discovery Platform, then Roche will pay FMI for the entirety of the FMI Development Costs FMI incurred in connection with FMIs performance of the Immunotherapy Testing Platform Development Work Stream, excluding any portion that was previously paid by Roche, or (B) if the effective date of termination occurs after FMIs commencement of Signature Identification services, then Roche will pay FMI for the entirety of the FMI Development Costs FMI incurred prior to the effective date of termination in connection with any ongoing performance of Signature Identification work by FMI, excluding any portion of such FMI Development Costs that was previously paid by Roche or that is payable by Roche under the foregoing clause (1); and (3) Roche shall pay FMI in accordance with Section 8.3.2 with respect to signatures developed by FMI prior to the effective date of termination. |
c. | In the event of termination of the ctDNA Platform Development Program Work Stream, Roche shall have no contractual payment obligation under this Section 17.3.2; provided, however, that Roche shall be obligated to honor payment obligations triggered prior to the effective date of termination; |
d. |
In the event of termination of the CDx Development Program Work Stream: for avoidance of doubt, Roche shall pay any FMI Development Costs in connection with the development of an Investigational Marker as specified by Section 8.5.1 incurred as of the effective date of termination that were not previously paid by Roche and any non-cancellable commitments reasonably incurred by FMI in |
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anticipation of receiving PMA with regard to any Investigational Marker to the extent not re-allocable to FMIs other business activities, including without limitation, all accrued amounts under any individual CDx R&D Plan entered into by the Parties as described in Section 3.4.8 above; (ii) if the effective date of such termination is after FMI has completed analytical validation of any Investigational Marker for inclusion in a CDx Assay, then Roche shall remain obligated to pay a fee for each such terminated Investigational Marker equal to [ *** ] upon PMA approval; and (iii) the milestone payments specified under Section 8.5.3 shall apply with respect to CDx Assays containing any Approved Marker and/or Investigational Marker; and |
e. | In the event of termination of the Agreement in its entirety under 17.2.2, Roche shall pay to FMI all amounts under the foregoing subsections (a) through (d) (inclusive) as applicable, if such fees become payable. |
(v) | FMI shall retain all rights and remedies available to it under law and equity in connection with breach by Roche under Section 17.2.1 or other termination under Section 17.2.2, Section 17.2.3, or 17.2.4, provided, however, that in the case of termination of the Molecular Information Platform Program under Section 17.2.1 or Section 17.2.3 above, FMIs exclusive remedy (other than for breach of confidentiality under Section 16.1) shall be the accelerated payments specified under Section 17.3.2(iv)a. |
For avoidance of doubt, in the event FMI terminates the Agreement in its entirety due to Roches Insolvency, all Work Streams and other activities under the Agreement will be deemed to be terminated and all of the applicable effects of termination in this Section 17.3.2 shall apply.
17.3.3 | Termination by Roche for Breach by FMI or FMI Insolvency |
Upon any termination by Roche for breach by FMI under Section 17.2.1 or FMIs Insolvency, under Section 17.2.2:
(i) | The rights and licenses granted by Roche to FMI under Section 2.1 shall terminate for each terminated Work Stream, on the effective date of termination, except that the rights granted to FMI under Section 2.1.2 shall survive such termination; |
(ii) | All licenses granted by FMI to Roche hereunder pertaining to a terminated Work Stream become fully paid up, perpetual and irrevocable; |
(iii) | The [ *** ] under Section 3.2.10 shall survive termination of the Immunotherapy Testing Platform Development Work Stream; |
(iv) | The [ *** ] under Section 3.3.9 shall survive termination of the ctDNA Platform Development Program Work Stream; |
(v) | Within [ *** ] after the effective date of termination and receipt by Roche of an accounting from FMI, FMI shall pay to Roche any unused Reserved Capacity Fees and Database Access Fees previously paid pursuant to Section 8.2.1.1 or any other unused and pre-paid amounts; |
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(vi) | FMI shall transfer to Roche all FMI Know-How, other than FMI Know-How pertaining to the Molecular Information Platform Program, necessary for Roche to practice the Terminated Matter, solely for the purposes or practicing the Terminated Matter, including any necessary algorithms; and |
(vii) | Roche shall retain all rights and remedies available to it under law and equity in connection with such breach by FMI. |
For avoidance of doubt, in the event Roche terminates the Agreement in its entirety due to FMIs Insolvency, all Work Streams and other activities under the Agreement will be deemed to be terminated and all of the applicable effects of termination in this Section 17.3.3 shall apply.
17.3.4 | Direct License |
Irrespective of anything to the contrary in this Agreement, any existing, permitted sublicense granted by a Party under this Agreement (and any further sublicenses thereunder) shall, upon a termination of the license granted hereunder that pertains to such sublicense, shall terminate; provided that if the licensee Party so requests in writing, the licensor Party shall negotiate with the relevant sublicensee towards the grant of a direct license of rights, provided that such sublicensee is not then in breach of its sublicense agreement with the licensee Party.
17.4 | Other Obligations |
Termination of this Agreement by a Party, for any reason, shall not release Roche from any obligation to make payments to FMI that are due and payable prior to the effective date of termination. Termination of this Agreement by a Party, for any reason, will release Roche from any obligation to any payments to FMI that would otherwise become due or payable on or after the effective date of termination.
17.5 | Survival |
In addition to any provisions that expressly survive in accordance with Article 17.3, Article 1 (Definitions, to the extent necessary to interpret the Agreement), Section 3.5.2 (Sample Handling and Disposal, to the extent applicable), Section 10 (Taxes), Section 12.1 (Ownership of Inventions), Section 12.9 (Common Interest Disclosures), Section 13.8.11 (Survival of Privacy and Security Obligations), Article 14 (Indemnification), Article 16 (Obligation Not to Disclose Confidential Information), Section 17.3 (Consequences of Termination), Section 17.5 (Surival), Section 19.1 (Governing Law), and Section 19.3 (Arbitration) shall survive any expiration or termination of this Agreement for any reason. Notwithstanding the foregoing, any provision of this Agreement that is intended by its very nature to survive expiration or termination of this Agreement shall also survive.
18. | Bankruptcy |
All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by FMI to Roche are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code (the Bankruptcy Code ) licenses of rights to intellectual property as defined under Section 101(35A) of the Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties agree that Roche, as a licensee or sublicensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued performance of its obligations under this Agreement.
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19. | Miscellaneous |
19.1 | Governing Law |
This Agreement shall be governed by and construed in accordance with the laws of New York, US, without reference to its conflict of laws principles, and shall not be governed by the United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention).
19.2 | Disputes |
Unless otherwise set forth in this Agreement, in the event of any dispute in connection with this Agreement, such dispute shall be referred to the respective executive officers of the Parties designated below or their designees, for good faith negotiations attempting to resolve the dispute. The designated executive officers are as follows:
For FMI: | CEO | |
For Roche: | Head of Roche Partnering |
19.3 | Arbitration |
Should the Parties fail to agree within [ *** ] after such dispute has first arisen, it shall be finally settled by arbitration in accordance with the Rules of American Arbitration Association (AAA) as in force at the time when initiating the arbitration. The tribunal shall consist of three arbitrators. The place of arbitration shall be New York, New York, US. The language to be used shall be English.
19.3.1 | Arbitrators |
Each Party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the request for arbitration within [ *** ] of being requested to do so, or if the respondent should fail to appoint an arbitrator in its answer to the request for arbitration within [ *** ] of being requested to do so, the other Party shall request the AAA to make such appointment.
The arbitrators nominated by the Parties shall, within [ *** ] from the appointment of the arbitrator nominated in the answer to the request for arbitration, and after consultation with the Parties, agree and appoint a third arbitrator, who will act as a chairman of the Arbitral Tribunal. Should such procedure not result in an appointment within the [ *** ] time limit, either Party shall be free to request the AAA to appoint the third arbitrator.
Where there is more than one claimant and/or more than one respondent, the multiple claimants or respondents shall jointly appoint one arbitrator.
Any Party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a replacement shall be appointed in accordance with the arrangements provided for in this clause.
The language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted together with an English translation.
19.3.2 | Decisions; Timing of Decisions |
The arbitrators shall render a written opinion setting forth findings of fact and conclusions of law with the reason therefor stated, within no later than [ *** ] from the date on which the arbitrators were appointed to the dispute. A transcript of the evidence adduced at the arbitration hearing shall be made and, upon request, shall be made available to each Party.
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The time periods set forth in the AAA Arbitration Rules shall be followed; provided however that the arbitrators may modify such time periods as reasonably necessary to render a written opinion in accordance with this Section 19.3.2.
The Arbitrator is empowered to award any remedy allowed by law, including money damages, prejudgment interest and attorneys fees, and to grant final, complete, interim, or interlocutory relief, including injunctive relief.
This arbitration agreement does not preclude either Party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either Partys domicile. Conservatory or interim measures sought by either Party in any one or more jurisdictions shall not preclude the Arbitral Tribunal granting conservatory or interim measures. Conservatory or interim measures sought by either Party before the Arbitral Tribunal shall not preclude any court of competent jurisdiction granting conservatory or interim measures.
In the event that any issue shall arise which is not clearly provided for in this Section 19.3, the matter shall be resolved in accordance with the AAA Arbitration Rules.
Any arbitration proceeding hereunder shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Partys Confidential Information. Except as required by law, neither Party shall make (or instruct the arbitrators to make) any public announcement with respect to the proceedings or decision of the arbitrators without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrators, except as required in connection with the enforcement of such award or as otherwise required by Applicable Law.
Notwithstanding anything to the contrary in this Agreement, any and all issues regarding the scope, construction, validity and/or enforceability of any Patent Rights shall be determined in a court of competent jurisdiction under the local patent laws of the jurisdictions having issued the Patent Rights in question.
Notwithstanding anything to the contrary in this Agreement, any and all issues regarding a breach or alleged breach of a Partys obligations under Article 16 (Obligation Not to Disclose Confidential Information) shall be determined in a court of competent jurisdiction under the laws of New York, with express exclusion of its conflict of laws principles.
19.4 | Assignment |
Neither Party shall have the right to assign the present Agreement or any part thereof to any Third Party other than Affiliates without the prior written approval of the other Party.
19.5 | Debarment and Exclusion |
19.5.1 | Past Activities |
Each Party represents and warrants that it has never been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care
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Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the above-referenced statutes, such Party shall immediately notify the other Party in writing and such other Party shall have the right, but not the obligation, to terminate this Agreement, effective, at such other Partys option, immediately or at a specified future date.
19.5.2 | Future Activities |
Each Party agrees that, to the best of its knowledge, none of its employees or agents conducting activities on its behalf under the Agreement is currently or will be during the term of this Agreement, debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party learns that any such employee or agent becomes so debarred, sanctioned, suspended, excluded or declared ineligible or is the subject of proceedings that may result in such debarment, sanction, suspension, exclusion or ineligibility, it will promptly so notify the other Party and will no longer allow such employee or agent to conduct activities under this Agreement.
19.6 | Independent Contractor |
No employee or representative of either Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any contractual or other liability on the other Party without said Partys prior written approval. For all purposes, and not- withstanding any other provision of this Agreement to the contrary, FMI legal relationship to Roche under this Agreement shall be that of independent contractor.
19.7 | Unenforceable Provisions and Severability |
If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties. However the remainder of this Agreement will remain in full force and effect, provided that the material interests of the Parties are not affected, i.e. the Parties would presumably have concluded this Agreement without the unenforceable provisions.
19.8 | Waiver |
The failure by either Party to require strict performance and/or observance of any obligation, term, provision or condition under this Agreement will neither constitute a waiver thereof nor affect in any way the right of the respective Party to require such performance and/or observance. The waiver by either Party of a breach of any obligation, term, provision or condition hereunder shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term, provision or condition.
19.9 | Appendices |
All Appendices to this Agreement shall form an integral part to this Agreement.
- 60 -
19.10 | Entire Understanding |
This Agreement contains the entire understanding between the Parties hereto with respect to the within subject matter and supersedes any and all prior agreements, understandings and arrangements, whether written or oral.
19.11 | Amendments |
No amendments of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and signed by both Parties.
19.12 | Invoices |
All invoices that are required or permitted hereunder shall be in writing and sent by FMI to Roche at the following address or other address as Roche may later provide:
F. Hoffmann-La Roche Ltd
Kreditorenbuchhaltung
4070 Basel
Switzerland
19.13 | Notice |
All notices that 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:
if to FMI, to: |
Foundation Medicine, Inc. 150 Second Street Cambridge, Massachusetts 02141 Attn: Legal Department Facsimile No.: +1 617 418 2201 |
|
if to Roche, to: |
F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel Switzerland Attn: Legal Department Facsimile No.: +41 61 688 13 96 |
|
and: |
Hoffmann-La Roche Inc. 150 Clove Road Suite 8 Little Falls, New Jersey 07424 US Attn. Corporate Secretary Facsimile No.: +1 973 890-8433 |
- 61 -
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.
[Signature Page Follows]
- 62 -
IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.
Foundation Medicine, Inc. | ||
/s/ Steven J. Kafka |
||
Name: | Steven J. Kafka | |
Title: | Chief Operating Officer |
F. Hoffmann-La Roche Ltd | ||||||||
/s/ Jason Coloma |
/s/ Stefan Arnold |
|||||||
Name: | Jason Coloma | Name: | Stefan Arnold | |||||
Title: | Global Head of Venture & Innovation, Roche Partnering | Title: | Head Legal Pharma |
Hoffmann-La Roche Inc. | ||
/s/ John P. Parise |
||
Name: | John P. Parise | |
Title: | Authorized Signatory |
Appendix 1.28
Excluded Patent Rights
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***Confidential Treatment Requested***
A-1
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***Confidential Treatment Requested***
A-2
Appendix 1.57
Performance Specifications
DNA Test Platform
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***Confidential Treatment Requested***
A-3
DNA Test Platform Gene List
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***Confidential Treatment Requested***
A-4
DNA + RNA Test Platform Gene List
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***Confidential Treatment Requested***
A-5
Appendix 1.64
R&D Plans (including budgets)
Immunotherapy Testing Platform Development
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***Confidential Treatment Requested***
A-6
ctDNA Platform Development Program
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***Confidential Treatment Requested***
A-7
CDx Development Program - [ *** ]
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***Confidential Treatment Requested***
A-8
CDx Development Program - [ *** ]
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***Confidential Treatment Requested***
A-9
CDx Development Program - [ *** ]
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***Confidential Treatment Requested***
A-10
CDx Development Program - [ *** ]
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***Confidential Treatment Requested***
A-11
Appendix 3.1.3
Form of Task Order
TASK ORDER FOR MOLECULAR INFORMATION PLATFORM AGREEMENT
This [ Insert number of Task Order ] Task Order is effective as of the last date below (Task Order # Effective Date.
TASK: [ Insert Task Name ]
FMI Reference Number : [ Insert FMI Reference Number ]
Roche Contact: | [ Insert Roche Contact ] |
This Task is divided into the following six sections:
A. | Task Activities Description of the Task Activities to be performed. |
B. | Schedule Task start date, projected end date and checkpoint dates (if any). |
C. | Dependencies Obligations, technology requirements. |
D. | Deliverables Identifiable work product resulting from the Task. |
E. | Fee Fixed price or time & materials rates and payment schedules. |
F. | Special Terms Terms applicable to this specific effort not addressed by this Agreement. |
A. | Task Activities |
[Describe Task Activities to be provided]
B. | Schedule |
[Describe schedule for Task Activities to be provided and specify the duration of the Task Activities]
C. | Dependencies |
[Describe dependencies as relating to the Task Activities]
D. | Deliverables |
[Describe deliverables as relating to the Task Activities]
E. | Fee |
[Describe payment schedule and form of payment for the Task Activities]
F. | Special Terms |
[Describe any special terms for the Task Activities]
Signatures of Project Managers
FMI | ROCHE | |||||||
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Date: |
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A-13
Appendix 3.1.6
Sample Report
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A-14
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A-15
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A-16
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A-17
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A-18
Appendix 3.2.4
Excluded Contracts
| [ *** ] |
| [ *** ] |
| [ *** ] |
| [ *** ] |
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A-19
Appendix 3.5.1
FMI Specimen Requirements
Appendix 16.3
Form of Press Release
See Exhibit 99.4 to this Form 8-K,
as filed on January 12, 2015.
A-23
Exhibit 10.3
EXECUTION COPY
***Text Omitted and Filed Separately with the Securities and Exchange Commission
Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Ex-US Commercialization Agreement
This Agreement is entered into with effect as of the Effective Date (as defined below)
by and between
F. Hoffmann-La Roche Ltd
with an office and place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland ( Roche )
on the one hand
and
Foundation Medicine, Inc.
with an office and place of business at 150 Second Street, Cambridge, Massachusetts 02141 (FMI )
on the other hand.
Table of Contents
1. |
Definitions |
1 | ||||
1.1 [ *** ] Region |
1 | |||||
1.2 Affiliate |
2 | |||||
1.3 Agreement |
2 | |||||
1.4 Agreement Term |
2 | |||||
1.5 Allocable Overhead Expenses |
2 | |||||
1.6 Applicable Law |
2 | |||||
1.7 Business Day |
2 | |||||
1.8 Calendar Quarter |
3 | |||||
1.9 Calendar Year |
3 | |||||
1.10 Commercially Launch(ed) |
3 | |||||
1.11 Commercially Reasonable Efforts |
3 | |||||
1.12 Confidential Information |
3 | |||||
1.13 Control |
3 | |||||
1.14 Cost of Services |
4 | |||||
1.15 Cover |
4 | |||||
1.16 Effective Date |
4 | |||||
1.17 EMA |
4 | |||||
1.18 EU |
4 | |||||
1.19 Existing Third Party Rights |
5 | |||||
1.20 FMI Know-How |
5 | |||||
1.21 FMI Patent Rights |
5 | |||||
1.22 FMI Territory |
5 | |||||
1.23 FMI Trademarks |
5 | |||||
1.24 FTE |
5 | |||||
1.25 Gross Margin |
5 | |||||
1.26 HSR |
5 | |||||
1.27 IFRS |
5 | |||||
1.28 Insolvency Event |
5 | |||||
1.29 JMC |
6 | |||||
1.30 JOC |
6 | |||||
1.31 Know-How |
6 | |||||
1.32 Net Sales |
6 | |||||
1.33 Non-Europe Region |
6 | |||||
1.34 [ *** ] Region |
6 | |||||
1.35 Party |
6 | |||||
1.36 Patent Rights |
6 | |||||
1.37 Post Approval Plan |
6 | |||||
1.38 Product |
6 | |||||
1.39 Quality Standards |
7 | |||||
1.40 Region |
7 | |||||
1.41 Regulatory Approval |
7 | |||||
1.42 Regulatory Authority |
7 | |||||
1.43 Roche Group |
7 | |||||
1.44 Sales |
7 | |||||
1.45 Sublicensee |
7 | |||||
1.46 Tactical Plan |
7 | |||||
1.47 Territory |
8 |
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1.48 Third Party |
8 | |||||
1.49 US |
8 | |||||
1.50 US$ |
8 | |||||
1.51 Additional Definitions |
8 | |||||
2. |
Licensesand Exclusivity |
9 | ||||
2.1 Licenses |
9 | |||||
2.2 Exclusive Right to Commercialize Products |
10 | |||||
3. |
Right to Include Future Products |
11 | ||||
4. |
Governance |
11 | ||||
4.1 Joint Management Committee |
11 | |||||
4.2 Joint Operational Committee |
11 | |||||
4.3 Members |
12 | |||||
4.4 Responsibilities of the JOC |
12 | |||||
4.5 Meetings |
13 | |||||
4.6 Minutes |
13 | |||||
4.7 Decisions |
13 | |||||
4.8 Information Exchange |
14 | |||||
4.9 Joint Operational Teams |
14 | |||||
4.10 Alliance Director |
14 | |||||
4.11 Limitations of Authority |
14 | |||||
4.12 Expenses |
14 | |||||
4.13 Lifetime |
14 | |||||
5. |
Supply |
14 | ||||
6. |
Regulatory |
15 | ||||
6.1 Responsibility |
15 | |||||
6.2 Clinical Trials |
15 | |||||
6.3 Reporting Adverse Events |
16 | |||||
6.4 Reimbursement |
16 | |||||
7. |
Commercialization |
16 | ||||
7.1 Business Planning Period |
16 | |||||
7.2 Reduction in Scope of Territory |
16 | |||||
7.3 Sales |
17 | |||||
7.4 Territory, Initial Launch and Launch Delay Fee |
17 | |||||
7.5 Responsibility |
17 | |||||
7.6 Branding and Pricing |
20 | |||||
7.7 Product Promotional Materials |
20 | |||||
8. |
Payment |
21 | ||||
8.1 General |
21 | |||||
8.2 Costs of Services |
21 | |||||
8.3 Royalty Payments and Sales Milestones |
22 | |||||
8.4 Disclosure of Payments |
23 | |||||
9. |
Accountingand Reporting |
23 | ||||
9.1 Timing of Payments |
23 | |||||
9.2 Late Payment |
23 | |||||
9.3 Method of Payment |
23 | |||||
9.4 Currency Conversion |
24 | |||||
9.5 Reporting |
24 | |||||
10. |
Taxes |
24 | ||||
11. |
Auditing |
24 |
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11.1 Right to Audit |
24 | |||||
11.2 Audit Reports |
25 | |||||
11.3 Over-or Underpayment |
25 | |||||
11.4 Duration of Audit Rights |
25 | |||||
12. |
Intellectual Property | 25 | ||||
12.1 Ownership of Inventions |
25 | |||||
12.2 Trademarks and Labeling |
25 | |||||
12.3 Prosecution of Patent Rights |
26 | |||||
12.4 Patent Coordination Team |
26 | |||||
12.5 Infringement |
26 | |||||
12.6 Defense |
26 | |||||
12.7 Common Interest Disclosures |
27 | |||||
13. |
Representationsand Warranties |
27 | ||||
13.1 FMI Representations and Warranties |
27 | |||||
13.2 Mutual Representations of the Parties |
28 | |||||
14. |
Indemnification |
29 | ||||
15. |
Liability |
29 | ||||
15.1 Disclaimer |
29 | |||||
16. |
ObligationNot to Disclose Confidential Information |
30 | ||||
16.1 Non-Use and Non-Disclosure |
30 | |||||
16.2 Permitted Disclosure |
30 | |||||
16.3 Press Releases |
30 | |||||
16.4 Publications |
30 | |||||
16.5 Commercial Considerations |
31 | |||||
17. |
Term and Termination |
31 | ||||
17.1 Commencement and Term |
31 | |||||
17.2 Termination |
31 | |||||
17.3 Consequences of Termination and Expiration |
32 | |||||
17.4 Survival |
36 | |||||
18. |
Bankruptcy |
36 | ||||
19. |
Miscellaneous |
36 | ||||
19.1 Governing Law |
36 | |||||
19.2 Disputes |
36 | |||||
19.3 Arbitration |
37 | |||||
19.4 Assignment |
38 | |||||
19.5 Compliance with Applicable Law |
38 | |||||
19.6 Debarment |
38 | |||||
19.7 Independent Contractor |
39 | |||||
19.8 Unenforceable Provisions and Severability |
39 | |||||
19.9 Waiver |
39 | |||||
19.10 Appendices |
39 | |||||
19.11 Entire Understanding |
39 | |||||
19.12 Amendments |
40 | |||||
19.13 Invoices |
40 | |||||
19.14 Notice |
40 | |||||
19.15 Subcontractors |
40 | |||||
19.16 Force Majeure |
41 |
- iv -
Ex-US Commercialization Agreement
WHEREAS, FMI has certain products that it currently commercializes, FoundationOne ® and FoundationOne ® Heme, and would like to commercialize, either by itself or through a collaborator, additional products in the future; and
WHEREAS, Roche has expertise in the commercialization of pharmaceutical and diagnostic products; and
WHEREAS, Roche and FMI want to collaborate on the commercialization of certain FMI products outside of the US; and
WHEREAS, Roche and FMI are concurrently herewith entering into that certain transaction agreement dated as of the date hereof (as it may be amended from time to time, the Transaction Agreement ) which provides, among other things, for Roche to acquire a majority ownership of FMI upon the terms and subject to the conditions set forth in the Transaction Agreement, and a related investor rights agreement, Investor Rights Agreement ); and
WHEREAS, in connection therewith, and as an inducement to Roches and FMIs willingness to enter into the Transaction Agreement and to consummate the transactions contemplated thereby, the Parties hereto agree that , Roche will work with FMI in the United States to educate relevant persons on next generation sequencing and/or comprehensive genomic profiling technology pursuant to the US educaton collaboration agreement dated as of the date hereof (as it may be amended from time-to-time, the US Education Collaboration Agreement ), Roche will collaborate with FMI on the development of genomic testing platforms ( Collaboration Agreement ), and Roche and FMI wll evaluate a collaboration on certain diagnostics, including certain decentralized IVD diagnostics generated by FMI pursuant to the IVD collaboration termsheet dated as of the date hereof (as it may be amended from time-to time, the IVD Collaboration , together with the US Education Collaboration Agreement and the IVD Collaboration, the Related Agreements ); and
WHEREAS, FMI and Roche intend that assays and other products generated under the Collaboration Agreement will be commercialized in accordance with this Agreement.
NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:
1. | Definitions |
As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:
1.1 | [ *** ] Region |
The term [ *** ] Region shall mean [ *** ].
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1.2 | Affiliate |
The term Affiliate shall mean any individual, corporation, association or other business entity that directly or indirectly controls, is controlled by, or is under common control with the Party in question. As used in this definition of Affiliate, the term control shall mean the direct or indirect ownership of more than fifty percent (>50%) of the stock having the right to vote for directors thereof or the ability to otherwise control the management of the corporation or other business entity whether through the ownership of voting securities, by contract, resolution, regulation or otherwise. Anything to the contrary in this paragraph notwithstanding, Chugai Pharmaceutical Co., Ltd, a Japanese corporation (Chugai), shall not be deemed an Affiliate of Roche unless Roche provides written notice to FMI of its desire to include Chugai as an Affiliate of Roche. Moreover, FMI and its Affiliates existing as of the Effective Date shall not be deemed Affiliates of Roche and its Affiliates existing as of the Effective Date, and Roche and its Affiliates existing as of the Effective Date shall not be deemed Affiliates of FMI and its Affiliates existing as of the Effective Date. Affiliates coming into existence after the Effective Date shall be classified by the Parties as either Roche Affiliates or FMI Affiliates for the purposes of this Agreement.
1.3 | Agreement |
The term Agreement shall mean this document including any and all appendices and amendments to it as may be added and/or amended from time to time in accordance with the provisions of this Agreement.
1.4 | Agreement Term |
The term Agreement Term shall mean the period of time commencing on the Effective Date and, unless this Agreement is terminated sooner as provided in Article 17, expiring five (5) years from the Effective Date ( Initial Term ) unless extended by Roche in writing at least [ *** ] prior to the expiration of the Initial Term (or any Renewal Term) (i) in its entirety, (ii) on a country-by-country, Region by Region and/or Product-by-Product basis, or (iii) by mutual agreement of the Parties, in each case for additional two (2) year periods (each a Renewal Term ) during any period of time in which the Aggregate Ownership Percentage (as defined in the Investor Rights Agreement) of Roche and its Affiliates is at least 50.1% (it being understood that this requirement is subject to Section 4.04 of the Investor Rights Agreement).
1.5 | Allocable Overhead Expenses |
The term Allocable Overhead Expenses shall mean costs incurred by a Party for its account which are attributable to the Partys supervisory, services, occupancy costs, corporate bonus (to the extent not charged directly to department), and its payroll, information systems, human relations or purchasing functions and which are allocated to company departments based on space occupied or headcount or other activity-based method. Allocable Overhead Expenses shall not include any costs attributable to general corporate activities including executive management, investor relations, business development, legal affairs and finance.
1.6 | Applicable Law |
The term Applicable Law shall mean any law, statute, ordinance, code, rule or regulation that has been enacted by a government authority (including without limitation, any Regulatory Authority) and is in force as of the Effective Date or comes into force during the Agreement Term, in each case to the extent that the same is applicable to the performance by the Parties of their respective obligations under this Agreement.
1.7 | Business Day |
The term Business Day shall mean 9:00 a.m. to 5:00 p.m. local time on a day other than a Saturday, Sunday or bank or other public or federal holiday in Switzerland, New Jersey or Massachusetts.
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1.8 | Calendar Quarter |
The term Calendar Quarter shall mean each period of three (3) consecutive calendar months, ending March 31, June 30, September 30, and December 31.
1.9 | Calendar Year |
The term Calendar Year shall mean the period of time beginning on January 1 and ending December 31, except for the first year which shall begin on the Effective Date and end on December 31.
1.10 | Commercially Launch(ed) |
The term Commercially Launch(ed) shall mean a commercial launch of a particular Product, which shall at a minimum require at least commercial scale sales, marketing and promotional activities using Commercially Reasonable Efforts.
1.11 | Commercially Reasonable Efforts |
The term Commercially Reasonable Efforts shall mean such level of efforts required to carry out such obligation in a sustained manner consistent with the efforts that Roche or FMI, as applicable, devotes at the same stage of development or commercialization, as applicable, for its own products with similar market potential, at a similar stage of their product life taking into account the existence of other competitive products in the market place or under development, the proprietary position of the product, the regulatory structure involved, the anticipated profitability of the product and other relevant factors. It is understood that such product potential may change from time to time based upon changing scientific, business and marketing and return on investment considerations.
1.12 | Confidential Information |
The term Confidential Information shall mean any and all information, data or know-how (including Know-How), whether technical or non-technical, oral or written, that is disclosed by one Party or its Affiliates ( Disclosing Party ) to the other Party or its Affiliates ( Receiving Party ). Confidential Information shall not include any information, data or know-how that:
(i) | was generally available to the public at the time of disclosure, or becomes available to the public after disclosure by the Disclosing Party other than through fault (whether by action or inaction) of the Receiving Party or its Affiliates, |
(ii) | can be evidenced by written records to have been already known to the Receiving Party or its Affiliates prior to its receipt from the Disclosing Party, |
(iii) | is obtained at any time lawfully from a Third Party under circumstances permitting its use or disclosure, |
(iv) | is developed independently by the Receiving Party or its Affiliates as evidenced by written records other than through knowledge of Confidential Information, or |
(vi) | is approved in writing by the Disclosing Party for release by the Receiving Party. |
The terms of this Agreement shall be considered Confidential Information of the Parties.
1.13 | Control |
The term Control shall mean (as an adjective or as a verb including conjugations and variations such as Controls Controlled or Controlling) (a) with respect to Patent Rights and/or Know-How, the possession by a Party of the ability to grant a license or sublicense of such Patent
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Rights and/or Know-How without violating the terms of any agreement or arrangement between such Party and any other party and (b) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any other party.
1.14 | Cost of Services |
The term Cost of Services means, as applicable to a Product, FMIs costs incurred in connection with sample preparation, sequencing, data analysis, medical curation and report generation (collectively, Service Activities for such Product), equal to (a) [ *** ] and (b) [ *** ]. The Cost of Services shall be calculated in accordance with GAAP, or IFRS, as applicable and as consistently applied by FMI in preparing its audited consolidated financial statements. FMI shall be solely responsible for all capital costs incurred in connection with providing the Service Activities for Products for use in the Territory, including without limitation building out capacity for such Products, provided that depreciation for any equipment used to provide the Service Activities will be included in the Cost of Services to the extent allocable to a Product in a manner consistent with FMIs internal and external accounting principles as consistently applied. Except as provided for in Section 8.2, Cost of Services will not include any transfer pricing mark-up. For clarity, any given deduction utilized in calculating Cost of Services (including the components thereof) shall be taken only once.
1.15 | Cover |
The term Cover shall mean (as an adjective or as a verb including conjugations and variations such as Covered, Coverage or Covering) that the developing, making, using, offering for sale, promoting, selling, exporting or importing of a given compound, formulation or product would infringe a valid claim in the absence of a license under the Patent Rights to which such valid claim pertains. The determination of whether a compound, formulation, process or product is covered by a particular valid claim shall be made on a country-by-country basis. As used in the previous sentence, valid claim means, with respect to a particular country a claim in an issued and unexpired patent that has not lapsed or been disclaimed, revoked, held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal and that has not been admitted to be invalid or unenforceable through re-examination, re-issue, disclaimer or otherwise, or lost in an interference proceeding.
1.16 | Effective Date |
The term Effective Date shall mean the effective date of the Collaboration Agreement.
1.17 | EMA |
The term EMA shall mean the European Medicines Agency or any successor agency with responsibilities comparable to those of the European Medicines Agency.
1.18 | EU |
The term EU shall mean the European Union and all its then-current member countries.
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1.19 | Existing Third Party Rights |
The term Existing Third Party Rights shall mean any Third Party rights granted by FMI to such Third Party relating to the Products in the Territory under an agreement with FMI existing as of the Effective Date. The Existing Third Party Rights are listed in Appendix 1.19.
1.20 | FMI Know-How |
The term FMI Know-How shall mean the Know-How that FMI Controls at the Effective Date and during the Agreement Term.
1.21 | FMI Patent Rights |
The term FMI Patent Rights shall mean the Patent Rights that FMI Controls Covering a Product or its use.
1.22 | FMI Territory |
The term FMI Territory shall mean (i) the US, (ii) any countries that have been excluded during or after the Business Planning Period, and (iii) any countries that have been removed from the Territory pursuant to the terms of this Agreement.
1.23 | FMI Trademarks |
The term FMI Trademarks shall mean all trademarks Controlled by FMI which are necessary or useful for use in connection with the commercialization of Products.
1.24 | FTE |
The term FTE shall mean a full-time equivalent person-year, based upon a total of no less than one thousand eight hundred (1,800) working hours per year, undertaken in connection with the conduct of research in the Research Program. In no circumstance can the work of any given person exceed one (1) FTE.
1.25 | Gross Margin |
The term Gross Margin shall mean Net Sales minus Cost of Services.
1.26 | HSR |
The term HSR shall mean the Hart-Scott-Rodino Antitrust Improvements Act.
1.27 | IFRS |
The term IFRS shall mean International Financial Reporting Standards.
1.28 | Insolvency Event |
The term Insolvency Event shall mean circumstances under which a Party (i) has a receiver or similar officer appointed over all or a material part of its assets or undertaking; (ii) passes a resolution for winding-up (other than a winding-up for the purpose of, or in connection with, any solvent amalgamation or reconstruction) or a court makes an order to that effect or a court makes an order for administration (or any equivalent order in any jurisdiction); (iii) enters into any composition or arrangement with its creditors (other than relating to a solvent restructuring); (iv) ceases to carry on business; (v) is unable to pay its debts as they become due in the ordinary course of business.
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1.29 | JMC |
The term JMC shall mean the joint management committee described in Article 6 of the Collaboration Agreement. If the Collaboration Agreement terminates before this Agreement, then the provisions of the Collaboration Agreement to the necessary to interpret or implement this Agreement shall be incorporated by reference into this Agreement.
1.30 | JOC |
The term JOC shall mean the joint operating committee as mentioned in the Collaboration Agreement and the US Education Collaboration Agreement, and described in Section 4.2.
1.31 | Know-How |
The term Know-How shall mean data, knowledge and information, including chemical manufacturing data, toxicological data, pharmacological data, preclinical data, assays, platforms, formulations, specifications, quality control testing data, that are necessary or useful for the discovery, manufacture, development or commercialization of Products.
1.32 | Net Sales |
The term Net Sales shall mean, for a Product in a particular period, the amount calculated by subtracting from the Sales of such Product for such period: (i) [ *** ].
1.33 | Non-Europe Region |
The Non-Europe Region shall mean all countries in the Territory excluding the [ *** ] Region and the [ *** ] Region.
1.34 | [ *** ] Region |
The term [ *** ] Region shall mean [ *** ].
1.35 | Party |
The term Party shall mean FMI or Roche, as the case may be, and Parties shall mean FMI and Roche collectively.
1.36 | Patent Rights |
The term Patent Rights shall mean all rights under any patent or patent application, in any country of the Territory, including any patents issuing on such patent application, and further including any substitution, extension or supplementary protection certificate, reissue, reexamination, renewal, division, continuation or continuation-in-part of any of the foregoing.
1.37 | Post Approval Plan |
The term Post Approval Plan shall mean the plan for regulatory (including the strategy with respect to Regulatory Approvals and reimbursement approvals for Products) and clinical activities associated with a Product in the Territory.
1.38 | Product |
The term Product shall mean (i) FoundationOne® and FoundationOne® Heme, and any updated and successor versions to FoundationOne® and FoundationOne® Heme, including any updated and successor versions with updated gene lists or that provide clinical outcome data (collectively, Initial Products ), (ii) any clinical diagnostic testing commercial products developed under the Immunotherapy Testing Platform Development Program (as defined in the
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Collaboration Agreement, the ctDNA Platform Development Program (as defined in the Collaboration Agreement), or the CDx Development Program (as defined in the Collaboration Agreement) (clause (ii) collectively, Collaboration Products ) subject to the terms of Section 8.3.5 , and (iii) any other products that the Parties mutually agree to include under this Agreement. The term Product shall include associated Service Activities provided in connection with Sales, [ *** ]. For clarity, (a) in vitro diagnostic kit products, (b) companion diagnostic assay products developed by FMI for Third Parties, and (c) any standalone data or molecular information products (i.e. other than clinical diagnostic testing commercial products), are excluded from the definition of a Product.
1.39 | Quality Standards |
The term Quality Standards shall mean (i) FMIs standard specifications in accordance with Section 2.3, with respect to the Products and performance of Service Activities, which shall include technical specifications on such Product and standards for the validation of such Product, and (ii) CLIA or QSR requirements, each as applicable to a Product, and other standards required by Applicable Laws in the Territory.
1.40 | Region |
The term Region shall mean the [ *** ] Region, the [ *** ] Region, and the Non-Europe Region.
1.41 | Regulatory Approval |
The term Regulatory Approval shall mean any approvals, licenses, registrations or authorizations by any Regulatory Authority, necessary to manufacture, sell, market or import or have imported any Product in the Territory.
1.42 | Regulatory Authority |
The term Regulatory Authority shall mean any national, supranational (e.g., the European Commission, the Council of the European Union, the European Medicines Agency), regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity including the EMA, in any country involved in the granting of Regulatory Approval for the Product.
1.43 | Roche Group |
The term Roche Group shall mean collectively Roche and its Affiliates and Sublicensees.
1.44 | Sales |
The term Sales shall mean, for a Product in a particular period, the sum of (i) and (ii) :
(i) |
the amount stated [
***
] for such period [
***
]. This amount reflects [
***
] in such period reduced by
[ *** ] taken in accordance with [ *** ]. By way of example [ *** ] taken in accordance [ *** ]: |
(a) | [ *** ]. |
(b) | [ *** ]. |
(c) | [ *** ]. |
(d) | [ *** ]. |
(e) | [ *** ]. |
For purposes of clarity, [ *** ] shall be excluded from Sales.
(ii) | [ *** ]. |
1.45 | Sublicensee |
The term Sublicensee shall mean a permitted entity to which Roche has licensed rights in accordance with Section 2.1.2 of this Agreement.
1.46 | Tactical Plan |
The term Tactical Plan shall mean the plan describing the tactics and logistics for marketing, promotion and sale of a Product in a specific country or Region, which shall address matters such as (i) annual minimum amounts of Product to be sold in such country or Region, (ii) details regarding the marketing support for the Products, and (iii) other activities to be conducted by either Party.
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1.47 | Territory |
The term Territory shall mean all countries of the world, excluding the FMI Territory.
1.48 | Third Party |
The term Third Party shall mean a person or entity other than (i) FMI or any of its Affiliates or (ii) a member of the Roche Group.
1.49 | US |
The term US shall mean the United States of America and its territories and possessions.
1.50 | US$ |
The term US$ shall mean US dollars.
1.51 | Additional Definitions |
Each of the following definitions is set forth in the Section of this Agreement indicated below:
Definition |
Section |
|
Accounting Period | 9.1 | |
Alliance Director | 4.10 | |
Arbitration Offer | 8.3.5 | |
Arbitration Commencement Date | 8.3.5 | |
Average Delivery Time Metric | 7.5.2.4 | |
Bankruptcy Code | 18 | |
Breaching Party | 17.2.1 | |
Business Planning Period | 7.1 | |
Chairperson | 4.2 | |
Collaboration Agreement | Whereas clause | |
Collaboration Product | 1.38 | |
Consensus Matters | 4.7.3 | |
Decision Period | 12.4 | |
Dependent Obligation | 7.5.1.4 | |
Disclosing Party | 1.12 | |
Expert | 8.3.5 | |
Extended Period | 7.4 | |
Global Cost | 8.2.1 | |
Global Test Fixed Fee | 8.2.1 | |
Indemnified Party | 14.3 | |
Indemnifying Party | 14.3 | |
Initial Discussion Period | 8.3.5 | |
Initial Term | 1.4 | |
Initial Product | 1.38 | |
Initiating Party | 12.4 | |
Investor Rights Agreement | Whereas clause | |
IVD Collaboration | Whereas clause |
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Definition |
Section |
|
JOT | 4.9 | |
Local Cost | 8.2.2 | |
Local Test Fixed Fee | 8.2.2 | |
Members | 4.2 | |
Minimum Price | 7.6 | |
Minimum Revenue Requirements | 1.1.1.1 | |
Minimum Transfer Payment | 17.3.4.3 | |
NGS | 7.4 | |
Non-Breaching Party | 17.2.1 | |
Panel | 8.3.5 | |
Payment Currency | 9.3 | |
Peremptory Notice Period | 17.2.1 | |
Precedent Obligation | 7.5.1.4 | |
Product Trademark | 12.2 | |
Publishing Notice | 16.4 | |
Publishing Party | 16.4 | |
Qualified Sample | 7.5.2.4 | |
Quarterly Average Delivery Time Failure | 7.5.2.4 | |
Rebuttal | 8.3.5 | |
Receiving Party | 1.12 | |
Related Agreements | Whereas clause | |
Renewal Term | 1.4 | |
Roche Transfer Activities | 17.3.4.3 | |
ROFN Negotiation Period | 3 | |
Royalty Term | 8.3.1 | |
Samples | 17.3.4.3 | |
Selected Agreement | 8.3.5 | |
Settlement | 12.4 | |
Service Activities | 1.14 | |
Suit Notice | 12.4 | |
Supporting Memorandum | 8.3.5 | |
Third Party Test Fee | 8.2.2 | |
Transaction Agreement | Whereas clause | |
Universal CDx Product | 2.2 | |
US Education Collaboration Agreement | Whereas clause |
2. | Licenses and Exclusivity |
2.1 | Licenses |
2.1.1 | Patents and Know-How |
Subject to the terms and conditions of this Agreement, FMI hereby grants to Roche a right and license, including the right to sublicense solely as permitted in Section 2.1.2, under FMIs interest in the FMI Patent Rights and FMI Know-How to use, have used, import, have imported, export,
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have exported, market, have marketed, distribute, have distributed, sell and have sold Products in the Territory. Subject to Section 2.2, the foregoing license shall be co-exclusive (with FMI) during the Business Planning Period and exclusive (even as to FMI) following the Business Planning Period.
2.1.2 | Sublicenses |
The licenses granted by FMI to Roche in Section 2.1.1 and 2.1.3 may be sublicensed by Roche to any Affiliate of Roche for so long as such Affiliate remains an Affiliate. Any such sublicense automatically terminates if such Affiliate Sublicensee ceases to be an Affiliate of Roche. In addition, the licenses granted by FMI to Roche in Section 2.1.1 and 2.1.3 (and any sublicense by Roche to an Affiliate of Roche) may be sublicensed (through one or more tiers) by Roche (and its Affiliates) to a Third Party (i) without the prior written consent of FMI in countries where Roche customarily utilizes such Third Party to conduct commercialization activities on behalf of Roche or its Affiliates or (ii) otherwise with the prior written consent of FMI, not to be unreasonably withheld. Roche shall be liable for any act or omission of any such Sublicensee that is a breach of any of Roches obligations under this Agreement as though the same were a breach by Roche, and FMI shall have the right to proceed directly against Roche without any obligation to first proceed against such Sublicensee.
2.1.3 | Trademarks |
Subject to the terms and conditions of this Agreement, FMI hereby grants to Roche a right and license, including the right to sublicense solely as permitted in Section 2.1.2, under FMIs interest in the FMI Trademarks to use, have used, import, have imported, export, have exported, market, have marketed, distribute, have distributed, sell and have sold Products in the Territory. Subject to Section 2.2, the foregoing license shall be co-exclusive (with FMI) during the Business Planning Period and exclusive (even as to FMI) following the Business Planning Period. Such trademark licenses shall be non-transferable, except that FMI shall have the right to sublicense such rights to its licensees in the FMI Territory, and Roche shall have the right to sublicense such rights to its permitted Sublicensees in the Territory.
2.2 | Exclusive Right to Commercialize Products |
During the Business Planning Period, FMI will continue to be responsible for and will book all sales of Products in the Territory.
After the Business Planning Period, Roche and its Sublicensees shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory, subject to activities designated for FMI to conduct under a Tactical Plan approved by the JOC. To the extent applicable, the foregoing right shall be subject to the rights granted under the Existing Third Party Rights. If FMI receives any order from a prospective purchaser located in a country in the Territory, FMI shall promptly refer that order to Roche, and Roche shall process such order for such purchaser in the Territory in accordance with the terms of this Agreement. If Roche receives any order from a prospective purchaser located in the FMI Territory, then Roche shall promptly refer that order to FMI. The Parties will discuss an appropriate transition plan for the Existing Third Party Rights. However, after the Business Planning Period, at Roches request, and to the extent possible under the Existing Third Party Rights without incurring any termination fee, penalty or similar fee, FMI will terminate any or all of the Existing Third Party Rights. Notwithstanding the above, if there is any termination fee, penalty or similar fee, Roche shall have the right to pay such termination fee, penalty or similar fee to terminate any or all of the Existing
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Third Party Rights. Moreover, Roche shall have the right, in coordination with FMI, to engage in negotiations with the Third Parties to which the Existing Third Party Rights pertain, with the intent of allowing Roche to intervene to terminate such Existing Third Party Rights.
Unless otherwise agreed expressly by the Parties, for any companion diagnostic assay Product that is also for use in indicating a therapeutic or referencing a clinical trial of a Third Party ( Universal CDx Product ), such Third Party shall have the right to recommend use of such Universal CDx Product in the Territory to the extent allowable under Applicable Law, including using or referencing such Universal CDx Product name, logo and trade dress in such Third Party therapeutics label, package insert, or in its promotional and regulatory materials.
2.3 | Product Specifications; Modifications |
Product specifications for the Initial Products are attached hereto as Appendix 2.3. FMI will develop product specifications for all other Products during development of each such Product. FMI will provide a copy of draft product specifications to the JOC for all other Products as such specifications are substantially completed. FMI will provide a copy of any material modifications to any Product specifications to the JOC no less than [ *** ] prior to anticipated locking of the design file, unless such changes are reasonably required to be implemented on an expedited basis, for example, to maintain compliance with Applicable Laws or the requirements of any Regulatory Authority, in which case FMI shall provide such specifications to the JOC as far in advance of implementation as is reasonably practicable. FMI shall consider in good faith any and all comments or concerns timely raised by Roche in connection with its review of such draft specifications or such modifications. FMI has final authority to adopt specifications for the Products and modifications thereto, [ *** ].
3. | Right to Include Future Products |
During the Agreement Term, Roche shall have a first right to negotiate with FMI to include in the Territory future clinical diagnostic testing commercial products Controlled by FMI (excluding (i) in vitro diagnostics kit products, (ii) any companion diagnostic assay products developed by FMI for a Third Party, and (iii) any standalone data or molecular information products (i.e. other than clinical diagnostic testing commercial products)), as a Product to market, distribute and sell in the Territory, on terms to be mutually agreed upon by the Parties. If FMI plans to Commercially Launch a clinical diagnostic testing commercial product in the Territory or grant such product rights to a Third Party, then FMI shall provide Roche with written notice of such plan and a copy of draft specifications for such Product. [ *** ].
4. | Governance |
4.1 | Joint Management Committee |
The roles and responsibilities of the JMC are set forth in the Collaboration Agreement.
4.2 | Joint Operational Committee |
The JOC serves to oversee all activities under this Agreement. The JOC will strive to reach consensus on any matters within its authority with each Party having one (1) vote. The JOC will reasonably consider all information, proposals and advice received from each Party in relation to the matters for which it has responsibility. Unresolved disputes at the JOC will be escalated to the JMC using the procedures outlined in the Collaboration Agreement.
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4.3 | Members |
The JOC shall be composed of an equal number of persons from each Party ( Members ). Roche and FMI each shall be entitled to appoint three (3) Members with appropriate seniority and functional expertise, unless otherwise agreed by the Parties. Each Party may replace any of its Members and appoint a person to fill the vacancy arising from each such replacement. A Party that replaces a Member shall notify the other Party at least [ *** ] prior to the next scheduled meeting of the JOC. Both Parties shall use reasonable efforts to keep an appropriate level of continuity in representation. Both Parties may invite a reasonable number of additional experts and/or advisors to attend part of or the whole JOC meeting with prior notification to the JOC. Members may be represented at any meeting by another person designated by the absent Member. The JOC shall be chaired [ *** ], and then alternating between the Parties on a [ *** ] basis thereafter ( Chairperson ).
4.4 | Responsibilities of the JOC |
The JOC shall have the responsibility and authority to:
(a) | create and approve a transition plan for Existing Third Party Rights; |
(b) | review and recommend for approval by the JMC Tactical Plans and Post Approval Plans for Products that Roche intends to Commercially Launch or has Commercially Launched; |
(c) | review and recommend for approval by the JMC any revisions to the Tactical Plans and Post Approval Plans; |
(d) | review and oversee execution of the Tactical Plans and Post Approval Plans; |
(e) | establish timelines for the Commercial Launch of any Products and the marketing, distribution and sale of such Products; |
(f) | identify appropriate resources necessary to conduct the Tactical Plans and Post Approval Plans; |
(g) | create, oversee or disband JOTs as deemed appropriate; |
(h) | establish and set expectations and mandates for JOTs, if applicable; |
(i) | resolve disputes of the ESWG (as such term is defined in the US Education Collaboration Agreement) in accordance with Section 2.2.3 of the US Education Collaboration Agreement; |
(j) | monitor and implement plans to ensure adequate Product supply in the Territory; |
(k) | review and approve product and corporate level branding for Products subject to Section 12.2 (Trademarks & Labeling); |
(l) | [ *** ]; |
(m) | review and recommend for approval by the JMC promotional materials outside of FMIs approved guidelines; |
(n) | review and recommend for approval by the JMC any clinical research for Products in the Territory; provided that the Parties may conduct clinical research without approval of the JMC in accordance with Section 6.2 (Clinical Trials); |
(o) | [ *** ]; |
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(p) | recommend action items to its respective decision making bodies; |
(q) | review Quality Standards and modifications thereto in accordance with Section 2.3 (Product Specifications and Modifications); |
(r) | review customer service practices and performance in accordance with Section 7.5.2.3 (Customer Service); |
(s) | review strategies for reimbursement approvals in accordance with Section 6.4 (Reimbursement); |
(t) | review Average Delivery Time Metric in accordance with Section 7.5.2.4; and |
(u) | attempt in good faith to resolve any disputes between the Parties. |
The JOC shall have no responsibility and authority other than that expressly set forth in this Section, in the Related Agreements or as otherwise agreed to in writing by both Parties.
4.5 | Meetings |
The Chairperson or his/her delegate will be responsible for sending invitations and agendas for all JOC meetings to all Members at least [ *** ] before the next scheduled meeting of the JOC. The venue for the meetings shall be agreed by the JOC. The JOC shall hold meetings at least [ *** ], either in person or by tele-/video-conference, and in any case as frequently as the Members of the JOC may agree shall be necessary, but not less than [ *** ]. The Alliance Director of each Party may attend the JOC meetings as a permanent participant.
4.6 | Minutes |
The Chairperson will be responsible for designating a Member to record in reasonable detail and circulate draft minutes of JOC meetings to all members of the JOC for comment and review within [ *** ] after the relevant meeting. The Members of the JOC shall have [ *** ] to provide comments. The Party preparing the minutes shall incorporate timely received comments and distribute finalized minutes to all Members of the JOC within [ *** ] of the relevant meeting. The Chairperson approves the final version of the minutes before its distribution.
4.7 | Decisions |
4.7.1 | Decision Making Authority |
The JOC shall decide matters within its responsibilities set forth in Section 4.4.
4.7.2 | Consensus; Good Faith |
The Members of the JOC shall act in good faith to cooperate with one another and seek agreement with respect to issues to be decided by the JOC. The Parties shall endeavor to make decisions by consensus with each Party having one (1) vote.
4.7.3 | Failure to Reach Consensus |
If the JOC is unable to decide a matter requiring JOC approval by consensus, then the matter shall be escalated to the [ *** ].
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4.8 | Information Exchange |
FMI and Roche shall exchange the information in relation to its activities under this Agreement through the JOC. FMI and Roche may ask reasonable questions in relation to the above information and offer advice in relation thereto and each Party shall give due consideration to the other Partys input. The JOC may determine other routes of information exchange. Notwithstanding anything to the contrary in this Agreement, if FMI, FMIs Affiliates or sublicensees have sales forces in a country/Region outside of the FMI Territory for a product after the Business Planning Period, then Roche shall have the right to redact competitively sensitive information, including within the Tactical Plans or Post Approval Plans provided to FMI for any Product in such country/Region.
4.9 | Joint Operational Teams |
The JOC shall have the right to establish joint operational teams ( JOT ), which shall have the authority granted to them by the JOC and shall be comprised of members from both Parties.
4.10 | Alliance Director |
Each Party shall appoint one person to be its point of contact with responsibility for facilitating communication and collaboration between the Parties (each, an Alliance Director ). The Alliance Directors shall be permanent participants of the JOC meetings (but not members of the JOC). The Alliance Directors shall facilitate resolution of potential and pending issues and potential disputes to enable the JOC to reach consensus and avert escalation of such issues or potential disputes.
4.11 | Limitations of Authority |
The JOC shall have no authority to amend or waive any terms of this Agreement.
4.12 | Expenses |
Each Party shall be responsible for its own expenses including travel and accommodation costs incurred in connection with the JOC.
4.13 | Lifetime |
The JOC shall exist during the Agreement Term.
5. | Supply |
Subject to Section 7.5.2.4, FMI shall be solely and exclusively responsible [ *** ] for the commercial supply of Products for sale in the Territory by or on behalf of Roche, and FMI shall use Commercially Reasonable Efforts to provide Products and Service Activities in the amounts requested by Roche meeting the Quality Standards and Average Delivery Time Metric.
For a given Product, if FMI fails to complete the Service Activities associated with such Product in a manner that meets such Products Quality Standards for at least [ *** ] of the Qualified Samples received from Roche in the Territory in a given Calendar Quarter (a Quarterly Quality Standards Failure ) and such failure exists for [ *** ], then prior to the end of such [ *** ], the JOC shall prepare a plan for improving such performance, which plan will be implemented in the [ *** ]. The JOC will monitor the implementation and effectiveness of such plan with a goal of achieving and maintaining compliance on a consistent basis for such Quality Standards. If, following the implementation of a plan by the JOC to improve such performance, FMI is unable to improve performance, and there is a Quarterly Quality Standards Failure for [ *** ] (a Material Performance Standards Failure ), then this shall be considered a material breach of this Agreement by FMI.
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[ *** ]. Roche shall have the right, during normal business hours and upon reasonable advanced notice, to audit any Third Party used by FMI or its Affiliates in the supply of Products and services related to Products to the extent permitted in any existing agreements with such Third Party contractors and in accordance with the terms and conditions of such agreements. Any new agreements entered into by FMI with respect to commercial supply of Products for sale in the Territory by or on behalf of Roche, shall provide Roche with the right to audit.
6. | Regulatory |
6.1 | Responsibility |
Except as otherwise agreed to by the Parties, FMI, [ *** ], shall be responsible for, in consultation with Roche, and shall use Commercially Reasonable Efforts in the preparation of applications for Regulatory Approvals, as well as all governmental approvals required to market, import, have imported, sell and have sold Products in the Territory. FMI shall be responsible for pursuing and compiling all regulatory filing documentation, and Roche shall reasonably assist FMI in preparing and submitting such regulatory filing documentation and interacting with Regulatory Authorities, for Products in the Territory. FMI or its Affiliates shall use Commercially Reasonable Efforts to prepare, or have prepared for it, all regulatory filings and Regulatory Approvals for all Products that are required to be submitted in each country of the Territory where Roche intends to Commercially Launch a Product or has Commercially Launched a Product. Roche shall reasonably assist FMI in submitting all such regulatory filings and Regulatory Approvals in FMIs name, unless prohibited by Applicable Law, in which case, to the extent required under Applicable Law, Roche shall file such regulatory filings and Regulatory Approvals in Roches name. Each Party shall promptly supply the other Party with a copy of all material communications related to a Product to or from any Regulatory Authority in the Territory, including (i) communications with respect to any visits by any governmental authority or Regulatory Authority to any facilities at which any Product is manufactured or sold in the Territory and (ii) any written or oral inquiries about, any procedures in connection with any Product in the Territory.
6.2 | Clinical Trials |
The Parties shall discuss at the JOC and consider any clinical research (including, without limitation, any investigator sponsored studies and studies with key opinion leaders) to be conducted for the Products during the Agreement Term that may be necessary or reasonably useful in furtherance of market development and access for Products in the Territory. Except as otherwise agreed to by the Parties, Roche shall have the right to conduct local clinical studies (including investigator sponsored studies and clinical studies with key opinion leaders) where such clinical research is for such local country or Region, provided that Roche shall consult with FMI through the JOC and consider in good faith any comments provided by FMI with respect to such strategy and conduct of such local clinical studies, [ *** ] in a given country in the Territory during the Agreement Term. Except as otherwise agreed to by the Parties, with respect to any global clinical studies, FMI shall have the right to conduct, [ *** ], and shall be responsible for the strategy and conduct of such global clinical studies, provided that FMI shall consult with Roche through the JOC and consider in good faith any comments provided by Roche with respect to such strategy and conduct of such global clinical studies. If the Parties do not mutually agree to conduct additional global clinical research for the Territory, FMI shall have the right, but not the obligation, to pursue such global clinical research in its sole discretion and shall be responsible for [ *** ].
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6.3 | Reporting Adverse Events |
If the development or commercialization or a given Product mandates the mutual reporting of adverse events, the Parties will establish procedures for tracking and informing each other concerning such adverse advents as required by law, and shall maintain such databases and execute such agreements as needed for this purpose.
6.4 | Reimbursement |
Roche will be responsible, [ *** ], in cooperation with FMI, for all activities related to reimbursement approval for Products in the Territory. Prior to submission, Roche shall discuss its proposed filings for reimbursement approval of Products at the JOC and shall consider in good faith any comments provided by FMI with respect to such filings. After those materials have been submitted to the appropriate pricing authority, Roche shall permit FMI to obtain copies of such materials, including in electronic format, at reasonable times. However, if FMI, FMIs Affiliates, or sublicensees have sales forces in a country/Region outside of the FMI Territory for a FMI clinical diagnostic product after the Business Planning Period, then Roche shall have the right to redact from such filings competitively sensitive information on reimbursement approvals to FMI for any Product in such country/Region. Roche shall use Commercially Reasonable Efforts to file submissions for reimbursement approval in each country where it intends to, or has, Commercially Launched a Product. For clarity, submissions for reimbursement approval in the Territory shall be consistent with the [ *** ] agreed upon by the Parties.
7. | Commercialization |
7.1 | Business Planning Period |
The Parties will use the first [ *** ] of the Initial Term (such [ *** ] period the Business Planning Period ) to explore and develop a plan for the commercialization of the Initial Products by Roche in the Territory.
During the Business Planning Period, the Parties will focus on an analysis of the market, prioritization of countries and Regions within the Territory with respect to market access and market development, and in the formation of strategies related to obtaining Regulatory Approval and reimbursement for Products in said prioritized countries and Regions.
Following the Business Planning Period, the Parties will implement on the strategies agreed to at the JOC and JMC, in a staged approach and according to detailed Tactical Plans and Post-Approval Plans for each country/Region. Unless otherwise agreed by the Parties, following the Business Planning Period, Roche shall have the exclusive right (even as to FMI) to market, distribute and sell Products in the Territory in accordance with the terms of this Agreement. Notwithstanding this exclusive right, the JOC shall consider utilizing FMI to conduct certain medical educational and/or medical affairs activities in connection with a Tactical Plan.
7.2 | Reduction in Scope of Territory |
During the Business Planning Period, Roche shall have the right to exclude countries or Regions from the Territory with immediate effect by providing written notice to FMI. Upon delivery of such written notice, the Territory shall be revised to remove such country or Region from the Territory and upon such country or Region shall be deemed to be included in the FMI Territory. For clarity,
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upon exclusion of any country or Region by Roche pursuant to this Section 7.2, the licenses and rights granted under this Agreement to Roche with respect to such country or Region, as applicable, shall automatically terminate and FMI shall have the sole right and discretion with respect to Products in such excluded country or Region.
7.3 | Sales |
Except as otherwise expressly agreed between the Parties, after the Business Planning Period:
(a) | Subject to the Existing Third Party Rights, Roche will book all sales of Products in the Territory. |
(b) | Subject to the Existing Third Party Rights, Roche will be responsible for billing and collections of Products in the Territory. |
7.4 | Territory, Initial Launch and Launch Delay Fee |
Following the Business Planning Period, and subject to FMI having fulfilled its obligations under this Agreement, if Roche fails to Commercially Launch the Initial Products in a given Region in the Territory in accordance with the schedule below, then Roche shall have the right to pay FMI a Launch Delay Fee [ *** ] (the Extended Period ). If Roche does not pay the Launch Delay Fee or thereafter Commercially Launch the Initial Products within the Extended Period, then FMI may, in its sole discretion, elect to (i) convert the licenses under Section 2.1 to non-exclusive, or (ii) terminate the licenses under Section 2.1 and remove the Regions from the Roche Territory (and upon such election such Region shall be deemed to be included in the FMI Territory) in each case (i) and (ii) other than in any country in such Region where Roche has already Commercially Launched prior to the end of the applicable period or Extended Period):
[ *** ].
For example, [ *** ]
Notwithstanding the foregoing, Roche shall not be required to pay any Launch Delay Fee if such failure to Commercially Launch is a result of FMI failing to meet its responsibilities under this Agreement, including providing [ *** ], and, Roche shall have an automatic extension of the deadline for the amount of time equal to the period in which FMI has not cured such failure before which Roche is required to launch in a Region. For clarity, upon FMIs cure of such failure, if Roche fails to meet the extended deadline for Commercial Launch, then Roche shall have the right to pay the Launch Delay Fee and obtain the extension or such Regions (other than any country in such Regions where Roche has already Commercial Launched) shall be deemed to be included in the FMI Territory.
7.5 | Responsibility |
7.5.1 | Roche Responsibilities |
7.5.1.1 | Funding Commitment |
Subject to FMI meeting its obligations under this Agreement, during the first [ *** ] of the Initial Term, Roche will commit at least [ *** ] in Roche FTE resources (based on Roches standard FTE rates as consistently applied). and out-of-pocket expenditures for the activities under this Agreement. FMI may audit Roche in accordance with Article 11 to ensure compliance with this Section. Notwithstanding the above, if there is a reduction in the scope of the Territory pursuant to Section 7.2, then FMI and Roche shall negotiate in good faith an adjustment to the [ *** ] commitment to equitably reflect the reduction in the market value of the Territory.
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7.5.1.2 | Minimum Revenue Requirement |
Commencing in [ *** ], in connection with the review of the Tactical Plan, [ *** ] (the Minimum Revenue Requirements ). If the Initial Product specifications are modified pursuant to Section 2.3, the JOC may establish new Minimum Revenue Requirements for such Initial Product for the year in which such modification occurs. Roche will [ *** ]. If Roche fails to meet the Minimum Revenue Requirements for an Initial Product in any country in the Territory for [ *** ], then FMI will have the right, in its sole discretion, to either (i) remove such country from the Territory (and upon such election such country shall be deemed to be included in the FMI Territory) or (ii) convert the license for such country to non-exclusive.
7.5.1.3 | Commercial Activities |
During the Business Planning Period, Roches activities shall focus [ *** ].
Throughout the Agreement Term, Roche will be responsible for the preparation of country-or Region-specific Tactical Plans and Post-Approval Plans for Products in the Territory, which shall be updated [ *** ] and submitted to the JOC for review and comment. All activities under this Agreement will be conducted in accordance with country- or Region-specific Tactical Plans and Post-Approval Plans to be developed by Roche, working in cooperation with FMI, subject to review and approval by the JMC.
Roche will use Commercially Reasonable Efforts to initiate and pursue market development and Commercially Launch Products in the Territory in accordance with the Tactical Plans, Post Approval Plans and the terms of this Agreement.
7.5.1.4 | Equitable Adjustments |
Where either Roche or FMI has an obligation under this Agreement (each such a Dependent Obligation ) that can only reasonably be fulfilled if the other Party first performs one or more of its specific contractual obligations hereunder (each a Precedent Obligation ), then, any deadline for the performance by Roche or FMI, as applicable, of such Dependent Obligation shall be tolled (i.e., the deadline shall be extended) for a period of time equal to the delay in the performance by such other Party of the relevant Precedent Obligation. For avoidance of doubt, each such deadline shall be similarly tolled to the extent achievement of an obligation under this Agreement is prevented by an event of force majeure as and to the extent provided in Section 19.16.
7.5.2 | FMI Responsibilities |
7.5.2.1 | Product Training |
FMI will provide Roche with NGS and Product training using Commercially Reasonable Efforts, including samples of each related training material used by FMI in the FMI Territory throughout the Term. Such training will be provided in the locations and on the schedule agreed to in the Tactical Plans. Each Party shall be responsible for their respective costs in relation thereto. For clarity, FMI trainers will provide this training at no charge to Roche.
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7.5.2.2 | Materials |
[ *** ], or more frequently when available throughout the Term, FMI will provide Roche with copies of its then current Product marketing material, and will share with Roche any Product brand, promotional, or similar plans, any market research plans and results, any educational materials or other information or analysis prepared by or for FMI related to the Products in the FMI Territory or in the Territory.
Unless otherwise agreed between the Parties, after the Business Planning Period, FMI will be responsible for Product sequencing, analysis and reporting services in accordance with the NGS Sequencing, Analysis and Reporting section below.
7.5.2.3 | Customer Service |
During the Business Planning Period, the JOC shall discuss and determine the reasonable levels of customer service assistance in addressing sales and technical support issues, customer inquiries, defective product and service replacements to be provided by the Parties in each country in the Territory consistent with the Tactical Plans, including in which local country languages and manner such customer service shall be provided. [ *** ]. FMI shall provide Roche with [ *** ] reports summarizing customer service assistance requests and inquiries (including a breakdown by percentage of the general issues or complaints raised by customers for each country).
7.5.2.4 | NGS Sequencing and Supply of Products and Service Activities |
FMI shall use Commercially Reasonable Efforts to provide Roche with the Service Activities (including NGS sequencing) necessary for Roche to implement the Tactical Plan and to meet the commercial need for Products sold by Roche in the Territory. Such Service Activities will meet the Quality Standards and the Average Delivery Time Metric. In the event of a shortfall/limited capacity of Products or Service Activities needed by both FMI and Roche, such available capacity shall be distributed [ *** ] with respect to the then-current volume used by each Party.
For each Product, FMI will provide the JOC with the average time between receipt by FMI of a processable sample meeting minimum tissue or other specimen requirements as set forth in FMIs standard operating procedures (such sample, a Qualified Sample ) and delivery by FMI of the results of testing for such Product (the Average Delivery Time Metric ). Such Average Delivery Time Metric will initially be [ *** ] days for FoundationOne® and [ *** ] days for FoundationOne® Heme. After the Business Planning Period and periodically thereafter, the Average Delivery Time Metric may be revised by mutual written agreement of the Parties for differences in logistical, regulatory and other relevant factors. For a given Product, if FMI fails to achieve the Average Delivery Time Metric for at least [ *** ] of the Qualified Samples received from Roche in the Territory in [ *** ] Calendar Quarter (a Quarterly Average Delivery Time Failure ) and such failure exists [ *** ], then prior to the end of such [ *** ], the JOC shall prepare a plan for improving such performance, which plan will be implemented in the [ *** ]. The JOC will monitor the implementation and effectiveness of such plan with a goal of achieving and maintaining compliance on a consistent basis for such Average Delivery Time Metric. If, following the implementation of a plan by the JOC to improve such performance, FMI is unable to improve performance, and there is a Quarterly Average Delivery Time Failure for an additional [ *** ] (a Material Average Delivery Time Failure ), then this shall be considered a material breach of this Agreement by FMI.
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To the extent feasible and permitted by Applicable Law and regulatory guidelines of applicable Regulatory Authorities, the initial sequencing will be conducted by FMI at FMIs laboratory and facilities in the US.
FMI shall use Commercially Reasonable Efforts to conduct or have conducted genomic sequencing locally for its Initial Products [ *** ] after the Business Planning Period ends. FMI shall provide Roche with a written plan for the set-up of such [ *** ] laboratories, and shall consider Roches reasonable comments thereto. FMI shall update Roche on the progress of the establishment of [ *** ] testing. Such [ *** ] activities shall be provided in at least the same quality and standards as the [ *** ] testing in effect as of the Effective Date. To the extent that local Third Party costs are passed through to Roche, such costs shall be negotiated in good faith and at arms length with no benefits being given to FMI to the advantage or FMI, its Affiliates, sublicensees or customers that cause a disadvantage or do not similarly benefit the Roche Group and its customers.
FMI will be solely responsible, [ *** ], for the establishment of such laboratories and all Regulatory Approvals necessary for the establishment and operation of such laboratory(ies). Without limiting the foregoing, the Parties expressly acknowledge that FMI may choose to work with [ *** ] .
Unless otherwise expressly agreed by the Parties, data and final analysis, including medical curation and report generation will be conducted by FMI. Final reports will be provided from FMI in English or in the local language, to the extent requested by Roche and agreed to by FMI. If FMI is unable to provide local sequencing on the timeline set forth in this Section 7.5.2.4, or if FMI is unable to provide the NGS sequencing necessary to meet Roches commercial requirements for a period of [ *** ], then the JOC shall meet to determine a plan for improving such performance and the JOC will monitor the implementation and effectiveness of such plan, and FMI will provide reasonable support, with a goal of ensuring ongoing access to sufficient local sequencing, which may include Roche (itself or with or through a Third Party acceptable to FMI) performing such local sequencing in a manner approved by FMI that meets FMIs requirements for performing subsequent Service Activities.
7.6 | Branding and Pricing |
Product branding and corporate-level branding will be discussed and agreed to at the JOC. The Parties will discuss at the JOC a [ *** ] in the Territory (the [ *** ]). Unless otherwise expressly agreed by the Parties, the list price for each Product in the Territory will be equal to or greater than the [ *** ] for such Product.
7.7 | Product Promotional Materials |
The Parties will collaborate and coordinate around development of any promotional or educational materials to be utilized for Products in the Territory leveraging FMIs existing materials.
After the Business Planning Period, Roche shall be responsible for the preparation of all product promotional material for use with the Products by Roche in the Territory. All such Product promotional material shall be consistent with reasonable brand and Product guidelines provided to Roche by FMI. Any Product promotional materials not consistent with such approved
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guidelines shall be subject to review and approval by FMI. Notwithstanding the foregoing, any Product promotional guidelines and materials approved by FMI to be used by Roche will be subject to final review and approval by Roche.
8. | Payment |
8.1 | General |
Except as otherwise expressly provided for in this Agreement, each Party shall bear its own costs for its activities under this Agreement, including without limitation, in connection with the Tactical Plans.
8.2 | Costs of Services |
8.2.1 | FMI Service Costs |
For each Product sold in the Territory, if FMI provides Service Activities for such Product, at FMIs laboratories and facilities in the United States, Roche will pay FMI [ *** ] (collectively the Global Cost ) [ *** ] (collectively, the Global Test Fixed Fee ). The Global Test Fixed Fee for a Product will be calculated on a trailing [ *** ] basis, and the Global Test Fixed Fee and calculation shall be provided to Roche within [ *** ] after each [ *** ] in the Agreement Term, based on the Global Test Fixed Fee as determined from the preceding [ *** ] and [ *** ], subject to audit by Roche in accordance with Article 11.
For each Product sold in the Territory if FMI provides initial sequencing in laboratories and facilities outside of the US, Roche will pay FMI [ *** ] (collectively, the Local Cost ), plus [ *** ] and [ *** ] (collectively, the US Cost ), [ *** ] collectively, the Local Test Fixed Fee ). The Local Test Fixed Fee for a Product will be calculated on a trailing [ *** ] basis, and the Local Test Fixed Fee and calculation shall be provided to Roche within [ *** ] after each [ *** ] in the Agreement Term, based on the Local Test Fixed Fee as determined from the preceding [ *** ] and fixed for such Calendar Quarter during the Agreement Term, subject to audit by Roche in accordance with Article 11.
FMI will submit invoices on a [ *** ] basis and Roche shall pay all Global Test Fixed Fees and Local Test Fixed Fees within [ *** ] following Roches receipt of an invoice for such fees.
8.2.2 | Third Party Service Costs |
FMI may have all or part of the Service Activities for Products in the Territory performed by a Third Party subject to the terms and conditions for Third Parties set forth in Section 7.5.2.4 or as otherwise agreed to in writing by Roche. In the event that all or part of the Service Activities are performed by a Third Party, Roche shall reimburse FMI [ *** ] (the Third Party Test Fee ), provided that (i) such Third Party Test Fees are negotiated in good faith and at arms length with no benefits being given to FMI to the advantage or FMI, its Affiliates, sublicensees or customers that cause a disadvantage or do not similarly benefit the Roche Group and its customers, and (ii) [ *** ].
Roche shall pay all Third Party Test Fees within [ *** ] following Roches receipt of an invoice for such fees.
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8.3 | Royalty Payments and Sales Milestones |
8.3.1 | Royalty Term |
Royalties shall be payable by Roche on [ *** ] of Initial Products on an aggregated basis for all Initial Products commencing on the first commercial sale of an Initial Product and continuing for so long as Roche is selling any Initial Product ( Royalty Term ).
8.3.2 | Royalty Rates |
The following royalty rates shall apply to the respective tiers of aggregate [ *** ] of Initial Products in the Territory, on an incremental basis, as follows: [ *** ].
For example, if [ *** ] of an Initial Product in the Territory, for the first [ *** ] in a given [ *** ], is [ *** ].
If then in the second [ *** ] of such [ *** ], the [ *** ] of an Initial Product in the Territory is also [ *** ] for such [ *** ] thus far, [ *** ].
For the purpose of calculating royalties of a Product, [ *** ] and the royalty rates shall be subject to the following adjustments, as applicable:
8.3.3 | Third Party Payments |
In the event that it is necessary for Roche to obtain a license from a Third Party for Third Party intellectual property rights to use or sell the Product in the Territory following the Effective Date, Roche shall have the right to deduct [ *** ] of any consideration actually paid to such Third Party for such license from the royalties otherwise due and payable by Roche to FMI under this Section 8.3; provided, however, that in no case shall such reduction lower the amount of royalties otherwise payable under this Section 8.3 by more than [ *** ].
8.3.4 | Sales Milestones |
Roche will pay a one-time, non-refundable sales milestone payment of Ten Million US Dollars (US$10,000,000) the first time the aggregate annual Gross Margin of [ *** ] in a given Calendar Year first reach One Hundred Million US Dollars (US$100,000,000). [ *** ]
8.3.5 | Collaboration Products |
The financial terms for any Product that is a Collaboration Product (including royalty rates and sales milestone payments) and the diligence obligations for any such Product (including Commercial Launch obligations and Minimum Revenue Requirements) must be mutually agreed to in writing by the Parties, taking into consideration the relative contributions made by each Party to the development of such Product, before such Product is included in this Agreement. Following FMIs decision to Commercially Launch a Collaboration Product in the Territory, FMI shall provide written notice to Roche, and if the Parties cannot agree to terms and conditions for the inclusion of such Collaboration Product as a Product in this Agreement within [ *** ] (the Initial Discussion Period ), then the Parties shall each select an independent Third Party expert who is neutral, disinterested and impartial, and has significant relevant experience in the development and commercialization of pharmaceutical products (the Expert ). Each Expert will within [ *** ] select a [ *** ] Expert to form a panel of [ *** ] Experts ( Panel ). The date on which such Panel is in place will be the Arbitration Commencement Date . Each Party shall within [ *** ] following the Arbitration Commencement Date prepare and deliver to both the Panel and the other Party its proposed financial terms (including royalty rates and sales
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milestone payments) and diligence obligations (including initial launch and minimum revenue requirements) (collectively, the Arbitration Offer ) to resolve the disputed matter for such Product and a memorandum (the Supporting Memorandum ) in support thereof; provided that such Arbitration Offer shall be on the same or substantially similar terms as the last offer made by such Party to the other Party during the Initial Discussion Period. The Panel will also be provided with a copy of this Agreement. Within [ *** ] after receipt of the other Partys Supporting Memorandum, each Party may submit to the Panel (with a copy to the other Party) a rebuttal to the other Partys Supporting Memorandum (a Rebuttal ), which may include a revision, marked to show changes, of either Partys proposed terms. Neither Party may have communications (either written or oral) with the Panel other than for the sole purpose of engaging the Panel or as expressly permitted in this Section 8.3.5. Within [ *** ] after the Panels receipt of each Partys Rebuttal (or the expiration of the period for the Parties to submit a Rebuttal, if earlier), the Panel will select, between the proposals provided by the Parties, the proposal that the Panel believes most accurately reflects an equitable result for FMI and Roche (the Selected Agreement ). The Panel shall not have the authority to modify a proposal initially submitted by a Party. The decision of the Panel shall be the sole, exclusive and binding remedy and the Selected Agreement shall become a binding and enforceable agreement between the Parties. The Panel will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching a decision regarding the dispute at issue. The Experts fees and expenses will be paid by the Party whose proposal is not selected by the Panel. Each Party will bear and pay its own expenses incurred in connection with any proceedings under this Section 8.3.5.
8.4 | Disclosure of Payments |
Each Party acknowledges that the other Party may be obligated to disclose this financial arrangement, including all fees, payments and transfers of value, as may be advisable or required under Applicable Law.
9. | Accounting and Reporting |
9.1 | Timing of Payments |
Roche shall calculate royalties [ *** ] (each being the last day of an Accounting Period ) and shall pay royalties on Net Sales within [ *** ] after the end of each Accounting Period in which such Net Sales occur.
9.2 | Late Payment |
Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at [ *** ] points above the average one-month Euro Interbank Offered Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days such payment is overdue.
9.3 | Method of Payment |
Royalties on Net Sales and all other amounts payable by Roche hereunder shall be paid by Roche in US Dollars (the Payment Currency ) to account(s) designated by FMI.
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9.4 | Currency Conversion |
When calculating the Sales of any royalty-bearing Product that occur in currencies other than the Payment Currency, Roche shall convert the amount of such sales into [ *** ] and then into the Payment Currency using [ *** ].
9.5 | Reporting |
With each payment Roche shall provide FMI in writing for the relevant [ *** ] on an aggregated basis for all Initial Products, and thereafter on a Product-by-Product basis, the following information:
[ *** ].
10. | Taxes |
FMI shall pay all sales, turnover, income, revenue, value added, and other taxes levied on account of any payments accruing or made to FMI under this Agreement.
If provision is made in law or regulation of any country for withholding of taxes of any type, levies or other charges with respect to any royalty or other amounts payable under this Agreement to FMI, then Roche shall promptly pay such tax, levy or charge for and on behalf of FMI to the proper governmental authority, and shall promptly furnish FMI with receipt of payment. Roche shall be entitled to deduct any such tax, levy or charge actually paid from royalty or other payment due FMI or be promptly reimbursed by FMI if no further payments are due to FMI. Each Party agrees to reasonably assist the other Party in claiming exemption from such deductions or withholdings under double taxation or similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted.
11. | Auditing |
11.1 | Right to Audit |
Each Party shall keep, and shall require its Affiliates and sublicensees/Sublicensees to keep, full, true and accurate books of account containing all particulars that may be necessary for the purpose of calculating all amounts payable under this Agreement, such as with respect to royalties in the case of Roche and Cost of Services in the case of FMI. Such books of accounts shall be kept at their principal place of business. At the expense of the auditing Party, the auditing Party shall have the right to engage an independent public accountant from a major, internationally recognized accounting firm, to perform, on behalf of the auditing Party an audit of such books and records of the audited Party and its Affiliates, its licensees and sublicensees/Sublicensees, that are deemed necessary by the auditing Partys independent public accountant for the period or periods requested by auditing Party and the correctness of any financial report or payments made under this Agreement.
Upon timely request and at least [ *** ] prior written notice from the auditing Party, such audit shall be conducted in the countries specifically requested by the auditing Party, during regular business hours in such a manner as to not unnecessarily interfere with the audited Partys normal business activities, and shall be limited to results in the [ *** ] prior to audit notification.
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Such audit shall not be performed more frequently than [ *** ] nor more frequently than [ *** ] with respect to records covering any specific period of time.
All information, data documents and abstracts herein referred to shall be used only for the purpose of verifying statements, shall be treated as the audited Partys Confidential Information subject to the obligations of this Agreement and need neither be retained more than [ *** ] after completion of an audit hereof, if an audit has been requested; nor more than [ *** ] from the end of the [ *** ] to which each shall pertain; nor more than [ *** ] after the date of termination of this Agreement.
11.2 | Audit Reports |
The auditors shall only state factual findings in the audit reports and shall not interpret the Agreement. The auditors shall share all draft audit reports with the audited Party before the draft report is shared with the auditing Party and before the final document is issued. The final audit report, if any, shall be shared with the audited Party at the same time it is shared with the auditing Party.
11.3 | Over-or Underpayment |
If the audit reveals an overpayment, such overpayment shall be credited against future payments owed by Roche for the amount of the overpayment or, if no further payments are owed by Roche, then FMI shall reimburse Roche for the amount of the overpayment within [ *** ]. If the audit reveals an underpayment, Roche shall make up such underpayment with the next payment or, if no further payments are owed by Roche, Roche shall reimburse FMI for the amount of the underpayment within [ *** ]. The audited Party shall pay for the audit costs if the underpayment/over receipt of the audited Party exceeds [ *** ] of the aggregate amount of payments owed with regard to the statements subject of the audit. Section 9.2 shall apply to this Section 11.3.
11.4 | Duration of Audit Rights |
The failure of FMI to request verification of any royalty calculation within the period during which corresponding records must be maintained under this Article 11 will be deemed to be acceptance of the royalty payments and reports.
12. | Intellectual Property |
12.1 | Ownership of Inventions |
Ownership of Inventions shall be as set forth in the Collaboration Agreement.
12.2 | Trademarks and Labeling |
The Parties shall attempt to use a uniform global trademark and logo for the Product; provided, that each Party may use its own trademarks and housemarks as it selects to promote the sale of the Product in the FMI Territory, with respect to FMI, and the Territory, with respect to Roche (collectively, excluding the housemarks, the Product Trademarks ). The Parties shall agree on at least [ *** ] Product Trademarks for each Product, with [ *** ] of the trademarks being the global trademark and the other(s) being trademarks to be held in reserve in case the global trademark cannot be used in [ *** ] or more countries. The placement and size of a Partys housemarks relative to Product Trademarks shall be approved by the JOC. Excluding the Roche housemarks, FMI shall own any global Product Trademarks used on or in connection with Products in the Territory, and shall, at its sole cost, be responsible for procurement, maintenance, enforcement and defense of such global Product Trademarks.
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Roche shall own its trademarks, including the Roche trademark and hexagon, and may use the Roche trademarks in connection with the Product as set forth in this Section. FMI shall not file any identical registrations or other filings in respect of any such housemarks owned by Roche. FMI shall own its housemark and any trademark it selects to promote the sale of the Product in the FMI Territory. Roche shall not file any identical registrations or other filings in respect of any such trademarks and housemarks owned by FMI.
Each Party shall maintain all registrations of such Product Trademarks owned by it and the other Party shall not file any registrations or other filings in respect of any of such Product Trademark owned by the Product Trademark owning Party without the Product Trademark owning Partys prior written consent. FMI shall use Commercially Reasonable Efforts to obtain and maintain Product Trademarks and to take reasonable measures to enforce oppositions and litigations in relation to the Product Trademarks.
Each Party shall use the Product Trademarks in accordance with sound trademark and trade name usage principles and in accordance with all Applicable Law as reasonably necessary to maintain the validity and enforceability of the Product Trademarks. Each Party recognizes that the trademarks owned by the other Party represents a valuable asset of such other Party, and that substantial recognition and goodwill are associated with such name, logo and trademarks. Each Party hereby agrees that, without prior written authorization of the other Party or as specifically permitted in this Agreement, it shall not use such other Partys trademarks for any purpose.
Each Party shall have the right to police its own trademarks and enforce its own trademarks. Each Party shall have the right to audit the other Party, its Affiliates, sublicensees/Sublicensees and contractors to ensure the quality of the Products to which the trademark is associated.
In the event either Party becomes aware of any infringement of any Product Trademark by a Third Party, such Party shall promptly notify the other Party and the Parties shall consult with each other and jointly determine the best way to prevent such infringement.
12.3 | Prosecution of Patent Rights |
Patent Rights shall be prosecuted as set forth in the Collaboration Agreement.
12.4 | Patent Coordination Team |
The JPT as defined in the Collaboration Agreement will address all issues related to Patent Rights.
12.5 | Infringement |
Infringement shall be addressed as set forth in the Collaboration Agreement. However, if Roche is commercializing a Product in a particular country in the Territory, then Roche shall have the first right to enforce Patent Rights in such country in the Territory.
12.6 | Defense |
If an action for infringement is commenced against either Party, its licensees or its sublicensees/Sublicensees, the provisions of the Collaboration Agreement shall apply.
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12.7 | Common Interest Disclosures |
With regard to any information or opinions disclosed pursuant to this Agreement by one Party to each other regarding intellectual property and/or technology owned by Third Parties, the Parties agree that they have a common legal interest in determining whether, and to what extent, Third Party intellectual property rights may affect the conduct of the activities under this Agreement. Accordingly, the provisions of the Collaboration Agreement shall apply in this regard.
13. | Representations and Warranties |
13.1 | FMI Representations and Warranties |
13.1.1 | Safety Data |
FMI warrants and represents that it has, and covenants that it will, continue to disclose to Roche as soon as possible during the Term (i) the results of all preclinical testing and human clinical testing Controlled by FMI relating to any Product and (ii) all information in its Control concerning side effects, injury, toxicity or sensitivity reaction and incidents or severity thereof with respect to any Product.
13.1.2 | Third Party Patent Rights |
FMI warrants and represents that, as of the Effective Date, it has no knowledge of the existence of any patent or patent application owned by or licensed to any Third Party that could prevent Roche from making, having made, using, offering for sale, selling or importing Product in the Territory.
13.1.3 | Ownership of Patent Rights |
With respect to each Product, FMI shall provide Roche with a list of all FMI Patent Rights in the Territory that could potentially be asserted with respect to the use, sale, offer for sale, import or export of such Product in the Territory. FMI shall then warrant and represent that it is the exclusive owner of all right, title and interest in, or is the exclusive licensee of, such FMI Patent Rights.
13.1.4 | Ownership of Trademarks |
FMI warrants and represents that it is the exclusive owner of all right, title and interest in, or is the exclusive licensee of the trademarks for the Initial Products in the Territory.
13.1.5 | Inventors |
FMI warrants and represents that for the inventors of the inventions disclosed and/or claimed in the disclosed FMI Patent Rights, FMI has obtained the assignment of, or a license under, all interest and all rights or licenses thereunder with respect to the FMI Patent Rights necessary to grant the licenses granted hereunder. All of FMIs employees, officers and consultants have executed agreements requiring assignment to FMI of all Inventions made by such individuals during the course of and as a result of their association with FMI.
13.1.6 | Grants |
FMI warrants and represents that to the best of FMIs knowledge and belief, FMI has the lawful right to grant Roche and its Affiliates the rights and licenses described in this Agreement.
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13.1.7 | Valid Claims |
As of the Effective Date, FMI warrants and represents that it is not in possession of any information that would, in its reasonable opinion, render invalid and/or unenforceable any claims in any issued patent licensed pursuant to this Agreement. FMI has no knowledge of any inventorship disputes concerning any FMI Patent Rights.
13.1.8 | Ownership and Validity of Know-How |
As of the Effective Date, FMI warrants and represents that FMIs Know-How relating to Products and Service Activities is legitimately in the possession of FMI and has not been misappropriated from any Third Party, and FMI has taken reasonable measures to protect the confidentiality of its Know-How.
13.2 | Mutual Representations of the Parties |
13.2.1 | Authorization |
As of the Effective Date, each Party warrants and represents to the other Party that the execution, delivery and performance of this Agreement by such Party and all instruments and documents to be delivered by such Party hereunder: (i) are within the corporate power of such Party; (ii) have been duly authorized by all necessary or proper corporate action; (iii) are not in contravention of any provision of the certificate of formation or limited liability company agreement of such Party; (iv) to the knowledge of such Party, will not violate any law or regulation or any order or decree of any court of governmental instrumentality; (v) will not violate the terms of any indenture, mortgage, deed of trust, lease, agreement, or other instrument to which such Party is a party or by which such Party or any of its property is bound, which violation would have a material adverse effect on the financial condition of such Party or on the ability of such Party to perform its obligations hereunder; and (vi) do not require any filing or registration with, or the consent or approval of, any governmental body, agency, authority or any other person, which has not been made or obtained previously (other than approvals required under the HSR Act, Regulatory Approvals required for the sale of Products and filings with Regulatory Authorities required in connection with Products).
13.2.2 | No Claims |
As of the Effective Date, each Party warrants and represents to the other Party that there are no claims or investigations (other than with respect to the Parties HSR filings), pending or threatened against such Party or any of its Affiliates, at law or in equity, or before or by any governmental authority relating to the matters contemplated under this Agreement or that would materially adversely affect such Partys ability to perform its obligations hereunder.
13.2.3 | No Conflict |
Each Party warrants and represents that neither it nor any of its Affiliates is or will be under any obligation to any person, contractual or otherwise, that is conflicting with the terms of this Agreement or that would impede the fulfillment of such Partys obligations hereunder.
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13.2.4 | Activities |
Each Party will perform all activities under this Agreement (i) in a professional manner, (ii) in conformance with the level or care and skill ordinarily exercised by other professional institutions in similar circumstances, and (iii) in compliance with Applicable Law.
14. | Indemnification |
14.1 | Indemnification by Roche |
Roche shall indemnify, hold harmless and defend FMI and its Affiliates, and their respective directors, officers, employees, independent contractors, and agents from and against any and all losses, expenses, cost of defense (including without limitation attorneys fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts FMI becomes legally obligated to pay because of any claim or claims brought by a Third Party against it to the extent that such claim or claims arise out of any member of the Roche Groups action or inactions in connection with activities under this Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of FMI.
14.2 | Indemnification by FMI |
FMI shall indemnify, hold harmless and defend Roche and its Affiliates, and their respective directors, officers, employees, independent contractors and agents from and against any and all losses, expenses, cost of defense (including without limitation attorneys fees, witness fees, damages, judgments, fines and amounts paid in settlement) and any amounts Roche becomes legally obligated to pay because of any claim or claims brought by a Third Party against it to the extent that such claim or claims arise out of FMIs and its Affiliates actions or inactions in connection with activities under this Agreement, except to the extent such losses, expenses, costs and amounts are due to the gross negligence or willful misconduct or failure to act of Roche.
14.3 | Procedure |
In the event of a claim by a Third Party against a Party entitled to indemnification under this Agreement ( Indemnified Party ), the Indemnified Party shall promptly notify the other Party ( Indemnifying Party ) in writing of the claim and the Indemnifying Party shall undertake and solely manage and control, at its sole expense, the defense of the claim and its settlement. The Indemnified Party shall cooperate with the Indemnifying Party and may, at its option and expense, be represented in any such action or proceeding by counsel of its choice. The Indemnifying Party shall not be liable for any litigation costs or expenses incurred by the Indemnified Party without the Indemnifying Partys written consent. The Indemnifying Party shall not settle any such claim unless such settlement fully and unconditionally releases the Indemnified Party from all liability relating thereto, unless the Indemnified Party otherwise agrees in writing.
15. | Liability |
15.1 | Disclaimer |
EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY PROVIDE ANY WARRANTIES, WHETHER WRITTEN OR ORAL, EXPRESS OR IMPLIED. FMI AND ROCHE DISCLAIM ALL OTHER WARRANTIES, WHETHER EXPRESS OR IMPLIED, WITH RESPECT TO EACH OF THEIR RESEARCH, DEVELOPMENT AND COMMERCIALIZATION
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EFFORTS HEREUNDER, INCLUDING, WITHOUT LIMITATION, WHETHER THE PRODUCTS CAN BE SUCCESSFULLY DEVELOPED OR MARKETED, THE ACCURACY, PERFORMANCE, UTILITY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS, MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE WHATSOEVER OF THE PRODUCTS. EXCEPT IN THE CASE OF A BREACH OF ARTICLE 16, AND WITHOUT LIMITING THE PARTIES OBLIGATIONS UNDER ARTICLE 14, IN NO EVENT SHALL EITHER FMI OR ROCHE BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY.
16. | Obligation Not to Disclose Confidential Information |
16.1 | Non-Use and Non-Disclosure |
During the Agreement Term and for [ *** ] thereafter, a Receiving Party shall (i) treat Confidential Information provided by Disclosing Party as it would treat its own information of a similar nature, (ii) take all reasonable precautions not to disclose such Confidential Information to Third Parties, without the Disclosing Partys prior written consent, and (iii) not use such Confidential Information other than for fulfilling its obligations under this Agreement. If any Confidential Information is required to be disclosed by the Receiving Party or its Affiliates to comply with a court or administrative order, the Receiving Party or its Affiliates will provide prompt notice to the Disclosing Party to enable the Disclosing Party to resist such disclosure.
16.2 | Permitted Disclosure |
Notwithstanding the obligation of non-use and non-disclosure set forth in Section 16.1, the Parties recognize the need for certain exceptions to this obligation, specifically set forth below, with respect to press releases, patent rights, publications, and certain commercial considerations.
16.3 | Press Releases |
Each Party shall provide the other with a copy of any draft press release related to the activities contemplated by this Agreement at least [ *** ] prior to its intended publication for such other Partys review. The reviewing Party may provide the releasing Party with suggested modification to the draft press release. The releasing Party shall consider, and shall not unreasonably disregard, the reviewing Partys suggestions in issuing its press release.
16.4 | Publications |
During the Agreement Term, the following restrictions shall apply with respect to disclosure by any Party of Confidential Information relating to the Product in any publication or presentation:
a) | Both Parties acknowledge that it is their policy for the studies and results thereof to be registered and published in accordance with their internal guidelines. The Parties shall have the right to jointly publish all studies, clinical trials and results conducted or generated in accordance with this Agreement to the extent both Parties have jointly participated in or collaborated in such clinical study or trial. To the extent any study or clinical trial is conducted solely by Roche with no participation by FMI, Roche, in accordance with its internal policies and procedures, shall have the right to publish all such studies, clinical trials and results thereof on the clinical trial registries that are maintained by or on behalf of Roche, and FMI shall not publish any such studies, clinical trials or results thereof on its clinical trial registry, provided however, the Roches clinical trial registry can be accessed via a link from FMIs clinical trial registry. |
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b) | A Party ( Publishing Party ) shall provide the other Party with a copy of any proposed publication or presentation at least [ *** ] prior to submission for publication so as to provide such other Party with an opportunity to recommend any changes it reasonably believes are necessary to continue to maintain the Confidential Information disclosed by the other Party to the Publishing Party in accordance with the requirements of this Agreement. The incorporation of such recommended changes shall not be unreasonably refused; and if such other Party notifies ( Publishing Notice ) the Publishing Party in writing, within [ *** ] after receipt of the copy of the proposed publication or presentation, that such publication or presentation in its reasonable judgment (i) contains an invention, solely or jointly conceived and/or reduced to practice by the other Party, for which the other Party reasonably desires to obtain patent protection or (ii) could be expected to have a material adverse effect on the commercial value of any Confidential Information disclosed by the other Party to the Publishing Party, the Publishing Party shall prevent such publication or delay such publication for a mutually agreeable period of time. In the case of inventions, a delay shall be for a period reasonably sufficient to permit the timely preparation and filing of a patent application(s) on such invention, and in no event less than [ *** ] from the date of the Publishing Notice. |
16.5 | Commercial Considerations |
Nothing in this Agreement shall prevent a Party or its Affiliates from disclosing Confidential Information of the other Party to (i) governmental agencies to the extent required or desirable to secure government approval for the manufacture or sale of Product in the Territory, and (ii) Third Parties acting on behalf of Roche, to the extent reasonably necessary to conduct the activities contemplated by this Agreement, provided such Third Parties are bound by confidentiality and non-use obligations with respect to such information that are no less stringent than those included in this Agreement. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such Confidential Information is required to be disclosed by the Receiving Party to comply with Applicable Law, to defend or prosecute litigation or to comply with governmental regulations, provided that the Receiving Party provides prior written notice of such disclosure to the Disclosing Party and, to the extent practicable, takes reasonable and lawful actions to minimize the degree of such disclosure
17. | Term and Termination |
17.1 | Commencement and Term |
This Agreement shall commence upon the Effective Date and continue for the Agreement Term.
17.2 | Termination |
17.2.1 | Automatic Termination |
This Agreement shall terminate automatically, without any notice or other action by any Party, upon the first to occur of (i) termination of the Transaction Agreement in accordance with its terms and (ii) the mutual written consent of the Parties.
17.2.2 | Termination for Breach |
A Party ( Non-Breaching Party ) shall have the right to terminate this Agreement in its entirety or on a country-by-country or Product-by-Product basis in the event the other Party ( Breaching
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Party ) is in breach of any of its material obligations under this Agreement. The Non-Breaching Party shall provide written notice to the Breaching Party, which notice shall identify the breach and, if applicable, the affected countries in which, and the affected Products with respect to which, the Non-Breaching Party intends to have this Agreement terminate. The Breaching Party shall have a period of [ *** ] after such written notice is provided ( Peremptory Notice Period ) to cure such breach. If the Breaching Party has a dispute as to whether such breach occurred or has been cured, it will so notify the Non-Breaching Party, and the expiration of the Peremptory Notice Period shall be tolled until the Parties agree or the arbitrators have determined in accordance with Section 19.3 that this Agreement was materially breached. It is understood and acknowledged that, during the pendency of such a dispute, all of the terms and conditions of this Agreement shall remain in effect, and the Parties shall continue to perform all of their respective obligations under this Agreement. Upon such agreement or determination of material breach or failure to cure, the Breaching Party may have the remainder of the Peremptory Notice Period to cure such breach. If such breach is not cured within the Peremptory Notice Period, then absent withdrawal of the Non-Breaching Partys request for termination, this Agreement shall terminate in accordance with the written notice provided by the Non-Breaching Party and such termination shall be effective as of the expiration of the Peremptory Notice Period. For clarity, Roche may terminate this Agreement under this Section 17.2.2 if there is a material diminution in the Quality Standards, except as permitted under Section 2.3, or if FMI is unwilling or unable to fulfill its obligations under Section 7.5.2, and FMI may terminate this Agreement under this Section 17.2.2 if Roche is unwilling or unable to fulfill its obligations under Section 7.5.1. Notwithstanding the foregoing, Roche may terminate this Agreement under this Section 17.2.2 if a Material Average Delivery Time Failure or Material Performance Standards Failure occurs by providing written notice to FMI within [ *** ] of such Material Average Delivery Time Failure or Material Performance Standards Failure, and no cure period as provided under this Section 17.2.2 shall be applicable for such termination.
17.2.3 | Insolvency |
A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within [ *** ] after the filing thereof.
17.2.4 | Termination by Roche without a Cause |
Roche shall have the right to terminate this Agreement at any time after the Initial Term on a Product-by-Product and/or country-by-country basis upon [ *** ] prior written notice. The effective date of termination under this Section 17.2.4 shall be the date [ *** ] after Roche provides such written notice to FMI.
17.3 | Consequences of Termination and Expiration |
17.3.1 | Termination by FMI for Breach by Roche or by Roche without a Cause, or Expiration of the Agreement Term. |
Upon any termination under Section 17.2.1, FMI for breach by Roche in accordance with Section 17.2.2, termination by Roche under Section 17.2.4, or upon expiration of the Agreement Term, the following shall apply:
a) | The rights and licenses granted by FMI to Roche under this Agreement shall terminate in their entirety or on a country-by-country basis, as applicable, on the effective date of termination. |
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b) | After the effective date of termination Roche shall, to the extent Roche has the right to do so, assign and transfer to FMI all regulatory filings and Regulatory Approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in Roches possession and control related to Product(s) in the country necessary for FMI to continue to commercialize the Product(s). All data shall be transferred in the form and format in which it is maintained by Roche. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to FMI. |
c) | Roche shall assign all clinical trial agreements, to the extent such agreements have not been cancelled and are assignable without Roche paying any consideration or commencing litigation in order to effect an assignment of any such agreement. |
d) | FMI shall, upon transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government approval for the sale of Product(s) in the country, (ii) Third Parties acting on behalf of FMI, its Affiliates or licensees, to the extent reasonably necessary for the sale of Product(s) in the country, and (iii) Third Parties to the extent reasonably necessary to market Product(s) in the country. |
17.3.2 | Termination by Roche for Breach by FMI or FMI Insolvency |
Upon a material breach of a material obligation under this Agreement by FMI pursuant to Section 17.2.1 or FMIs Insolvency pursuant to Section 17.2.2, at Roches option, (i) Roche may seek damages via arbitration under Section 19.3 or (ii) as Roches exclusive remedy (other than for breach of confidentiality under Section 16) FMI shall pay to Roche either a one-time payment reflecting the value of the terminated Product(s) or a royalty on sales of such terminated Product(s) based on the royalty that Roche would have paid to FMI had the Agreement not terminated, the amount of which will be agreed to by the Parties negotiating in good faith. If the Parties cannot agree on the amount in clause (ii) above, then the determination of such amount shall be referred to a Panel in a manner analogous to that found in Section 8.3.5.
Upon any termination by Roche for breach by FMI in accordance with Section 17.2.1 or for FMIs insolvency in accordance with Section 17.2.2, the following shall apply:
a) | the rights and licenses granted by FMI to Roche under this Agreement shall terminate in their entirety or on a country-by-country and Product-by-Product basis, as applicable, on the effective date of termination. |
b) | After the effective date of termination Roche shall, to the extent Roche has the right to do so, assign and transfer to FMI all regulatory filings and Regulatory Approvals, all final pre-clinical and clinical study reports and clinical study protocols, and all data, including clinical data, in Roches possession and control related to Product(s) in the country necessary for FMI to continue to commercialize the Product(s). All data shall be transferred in the form and format in which it is maintained by Roche. Original paper copies shall only be transferred, if legally required. Roche shall not be required to prepare or finalize any new data, reports or information solely for purposes of transfer to FMI. |
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c) | Roche shall assign all clinical trial agreements, to the extent such agreements have not been cancelled and are assignable without Roche paying any consideration or commencing litigation in order to effect an assignment of any such agreement. |
d) | FMI shall, upon transfer, have the right to disclose such filings, approvals and data to (i) governmental agencies of the country to the extent required or desirable to secure government approval for the sale of Product(s) in the country, (ii) Third Parties acting on behalf of FMI, its Affiliates or licensees, to the extent reasonably necessary for the sale of Product(s) in the country, and (iii) Third Parties to the extent reasonably necessary to market Product(s) in the country. |
17.3.3 | Direct License |
Upon termination of this Agreement pursuant to Sections 17.2.2 or 17.2.3, with respect to any existing, permitted sublicense granted by Roche under Section 2.1.2(ii) of this Agreement (and any further sublicenses thereunder) upon the written request of Roche, (i) if the sublicense was consented to by FMI or is to Chugai, then the sublicense shall survive termination provided such Sublicensee (a) is not then in breach of its sublicense agreement and (b) such Sublicensee agrees to be bound to FMI under the terms and conditions of such sublicense agreement, and (ii) if the sublicense was not consented to by FMI, then FMI shall negotiate in good faith with the applicable Sublicensee the terms under which such sublicense shall survive such termination, provided that (a) such Sublicensee is not then in breach of its sublicense agreement (and, in the case of termination by FMI for breach by Roche, that such Sublicensee and any further sublicensees did not cause the breach that gave rise to the termination by FMI); and (b) such Sublicensee agrees to be bound to FMI under the terms and conditions of such sublicense agreement.
17.3.4 | Other Obligations |
17.3.4.1 | Obligations Related to Ongoing Activities |
Upon the effective date of termination of this Agreement, each Party (a) shall have the right to cancel all ongoing obligations as of the effective date of termination and (b) shall complete all non-cancellable obligations at its own expense.
From the date of notice of termination until the effective date of termination, Roche and FMI shall each continue their activities, including preparatory activities, ongoing as of the date of notice of termination. However, neither Party shall be obliged to initiate any new activities not ongoing at the date of notice of termination.
After the effective date of termination, neither Party shall have an obligation to perform and/or complete any activities or to make any payments for performing or completing any activities after such effective date of termination under this Agreement, except as expressly stated herein.
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Notwithstanding the foregoing, (a) in case of termination by FMI under Section 17.2.2 or 17.2.3 or by Roche under Section 17.2.4, upon the request of FMI, Roche shall complete any clinical studies related to the Product(s) that are being conducted by Roche for the Product(s) and are ongoing as of the effective date of termination, and (b) in case of termination by Roche under Section 17.2.2 or 17.2.3, upon the request of Roche, FMI shall complete any clinical studies related to the Product(s) that are being conducted by FMI for the Product(s) and are ongoing as of the effective date of termination; provided, however, that
(i) | both FMI and Roche in their reasonable judgment have concluded that completing any such clinical studies does not present an unreasonable risk to patient safety; |
(ii) | neither Party shall have an obligation to recruit or enroll any additional patients after the effective date of termination; and |
(iii) | FMI agrees to reimburse Roche for all of its development costs that incurred by or on behalf of Roche after the effective date of termination in completing such clinical studies as per subsection (a) above and Roche agrees to reimburse FMI for all of its development costs that incurred by or on behalf of Roche after the effective date of termination in completing such clinical studies as per subsection (b) above. |
17.3.4.2 | Ancillary Agreements |
Unless otherwise agreed by the Parties, the termination of this Agreement shall cause the automatic termination of all ancillary agreements related hereto, including but not limited to supply or quality agreements, if any, but shall not cause the termination of the Related Agreements unless specifically stated in such Related Agreement.
17.3.4.3 | Limitations on Grant-Backs; Transfer Expenses |
For purposes of clarity, irrespective of anything to the contrary in this Agreement:
a) | All transfers and licenses from Roche to FMI or other obligations of Roche under Section 17.3 are solely with respect to Product(s). |
b) | In connection with clinical trials, Roche may have collected human samples and related clinical information for additional limited research and development programs ( Samples ). Legal and contractual restrictions may apply to such Samples, in particular as Samples may qualify as personal identifiable information. FMI acknowledges and accepts that notwithstanding anything herein, Roche shall not be obliged to transfer any such Samples to FMI. |
c) | Nothing in this Agreement shall be construed as granting FMI any license under the intellectual property of Roche or its Affiliates in existence as of the Effective Date. |
d) |
Except with respect to termination by FMI for Roches breach pursuant to Section 17.2.2, FMI shall promptly reimburse Roche for all reasonable out-of-pocket costs and expenses (including FTE charges based on Roches standard FTE rates) incurred by or on behalf of Roche for transfer of documents and materials as requested by FMI under this Article 17; however transfer activities corresponding to the return of material remains, data, reports, |
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records, documents, Regulatory Filings and Regulatory Approvals originally provided by FMI to Roche ( FMI-Originated Transfer Activities ) shall be at no expense to FMI. If FMI desires Roche Transfer Activities other than FMI-Originated Transfer Activities, FMI shall make a payment to Roche of [ *** ] ( Minimum Transfer Payment ). The Minimum Transfer Payment shall be non-refundable, but shall be fully creditable against FMIs reimbursement for the Roche Transfer Activities. Roche shall be under no obligation to provide Roche Transfer Activities (beyond the FMI-Originated Transfer Activities) prior to receipt of the Minimum Transfer Payment. |
17.3.5 | Royalty and Payment Obligations |
Termination of this Agreement by a Party, for any reason, shall not release Roche from any obligation to pay royalties or make any payments to FMI that are payable for sales of Product prior to the effective date of termination. Termination of this Agreement by a Party, for any reason, will release Roche from any obligation to pay royalties or make any payments to FMI that would otherwise become payable on or after the effective date of termination.
17.4 | Survival |
Article 1 (Definitions, to the extent necessary to interpret the Agreement), Article 10 (Taxes) Article 11 (Auditing), Article 12 (Intellectual Property, to the extent relating to intellectual property existing at the time of termination), Article 14 (Indemnification, to the extent relating to claims existing at the time or termination), Article 16 (Obligation Not to Disclose Confidential Information), Section 17.3 (Consequences of Termination and Expiration, to the extent applicable), Section 17.4 (Survival), Section 19.1 (Governing Law) and Section 19.3 (Arbitration) shall survive any expiration or termination of this Agreement for any reason. Notwithstanding the foregoing, any provision of this Agreement that is intended by its very nature to survive expiration or termination of this Agreement shall also survive.
18. | Bankruptcy |
All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by FMI to Roche are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code (the Bankruptcy Code ) licenses of rights to intellectual property as defined under Section 101(60) of the Bankruptcy Code. Unless Roche elects to terminate this Agreement, the Parties agree that Roche, as a licensee or sublicensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under the Bankruptcy Code, subject to the continued performance of its obligations under this Agreement.
19. | Miscellaneous |
19.1 | Governing Law |
This Agreement shall be governed by and construed in accordance with the laws of New York, US, without reference to its conflict of laws principles, and shall not be governed by the United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention).
19.2 | Disputes |
Unless otherwise set forth in this Agreement, in the event of any dispute in connection with this Agreement, such dispute shall be referred to the respective executive officers of the Parties designated below or their designees, for good faith negotiations attempting to resolve the dispute. The designated executive officers are as follows:
For FMI: | CEO | |
For Roche: | Head of Roche Partnering or the CEO of the Roche Group in the case of Minimum Revenue Requirements. |
***Confidential Treatment Requested***
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19.3 | Arbitration |
Should the Parties fail to agree within [ *** ] after such dispute has first arisen, it shall be finally settled by arbitration in accordance with the Rules of American Arbitration Association (AAA) as in force at the time when initiating the arbitration. The tribunal shall consist of three arbitrators. The place of arbitration shall be New York, New York, US. The language to be used shall be English.
19.3.1 | Arbitrators |
Each Party shall nominate one arbitrator. Should the claimant fail to appoint an arbitrator in the request for arbitration within [ *** ] of being requested to do so, or if the respondent should fail to appoint an arbitrator in its answer to the request for arbitration within [ *** ] of being requested to do so, the other Party shall request the AAA to make such appointment.
The arbitrators nominated by the Parties shall, within [ *** ] from the appointment of the arbitrator nominated in the answer to the request for arbitration, and after consultation with the Parties, agree and appoint a third arbitrator, who will act as a chairman of the Arbitral Tribunal. Should such procedure not result in an appointment within the [ *** ] time limit, either Party shall be free to request the AAA to appoint the third arbitrator.
Where there is more than one claimant and/or more than one respondent, the multiple claimants or respondents shall jointly appoint one arbitrator.
Any Party-appointed arbitrator or the third arbitrator resigns or ceases to be able to act, a replacement shall be appointed in accordance with the arrangements provided for in this clause.
The language of the arbitration shall be English. Documents submitted in the arbitration (the originals of which are not in English) shall be submitted together with an English translation.
19.3.2 | Decisions; Timing of Decisions |
The arbitrators shall render a written opinion setting forth findings of fact and conclusions of law with the reason therefor stated, within no later than [ *** ] from the date on which the arbitrators were appointed to the dispute. A transcript of the evidence adduced at the arbitration hearing shall be made and, upon request, shall be made available to each Party.
The time periods set forth in the AAA Arbitration Rules shall be followed; provided however that the arbitrators may modify such time periods as reasonably necessary to render a written opinion in accordance with this Section 19.3.2.
The Arbitrator is empowered to award any remedy allowed by law, including money damages, prejudgment interest and attorneys fees, and to grant final, complete, interim, or interlocutory relief, including injunctive relief.
***Confidential Treatment Requested***
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This arbitration agreement does not preclude either Party seeking conservatory or interim measures from any court of competent jurisdiction including, without limitation, the courts having jurisdiction by reason of either Partys domicile. Conservatory or interim measures sought by either Party in any one or more jurisdictions shall not preclude the Arbitral Tribunal granting conservatory or interim measures. Conservatory or interim measures sought by either Party before the Arbitral Tribunal shall not preclude any court of competent jurisdiction granting conservatory or interim measures.
In the event that any issue shall arise which is not clearly provided for in this Section 19.3, the matter shall be resolved in accordance with the AAA Arbitration Rules.
Any arbitration proceeding hereunder shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Partys Confidential Information. Except as required by law, neither Party shall make (or instruct the arbitrators to make) any public announcement with respect to the proceedings or decision of the arbitrators without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and the award, shall be kept in confidence by the Parties and the arbitrators, except as required in connection with the enforcement of such award or as otherwise required by Applicable Law.
Notwithstanding anything to the contrary in this Agreement, any and all issues regarding the scope, construction, validity and/or enforceability of any Patent Rights shall be determined in a court of competent jurisdiction under the local patent laws of the jurisdictions having issued the Patent Rights in question.
Notwithstanding anything to the contrary in this Agreement, any and all issues regarding a breach or alleged breach of a Partys obligations under Article 16 (Obligation Not to Disclose Confidential Information) shall be determined in a court of competent jurisdiction under the laws of New York, with express exclusion of its conflict of laws principles.
19.4 | Assignment |
Neither Party shall have the right to assign the present Agreement or any part thereof to any Third Party other than Affiliates without the prior written approval of the other Party.
19.5 | Compliance with Applicable Law |
Each Party shall comply with Applicable Law in conducting activities and carrying out responsibilities under this Agreement[, including the U.S. Foreign Corrupt Practices Act of 1977, as amended, (collectively hereinafter the FCPA ) and anti-bribery laws in the countries in the Territory where Roche has its principal place of business and where it conducts activities under this Agreement.
19.6 | Debarment |
Each Party represents and warrants that it has never been debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party receives notice of debarment, suspension, sanction, exclusion, ineligibility or disqualification under the above-referenced statutes, such Party shall [ *** ].
***Confidential Treatment Requested***
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Each Party agrees that, to the best of its knowledge, none of its employees or agents conducting activities on its behalf under the Agreement is currently or will be during the term of this Agreement, debarred under 21 U.S.C. §335a, disqualified under 21 C.F.R. §312.70 or §812.119, sanctioned by a Federal Health Care Program (as defined in 42 U.S.C §1320 a-7b(f)), including without limitation the federal Medicare or a state Medicaid program, or debarred, suspended, excluded or otherwise declared ineligible from any other similar Federal or state agency or program. In the event a Party learns that any such employee or agent becomes so debarred, sanctioned, suspended, excluded or declared ineligible or is the subject of proceedings that may result in such debarment, sanction, suspension, exclusion or ineligibility, it will promptly so notify the other Party and will no longer allow such employee or agent to conduct activities under this Agreement.
19.7 | Independent Contractor |
No employee or representative of either Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any contractual or other liability on the other Party without said Partys prior written approval. For all purposes, and not- withstanding any other provision of this Agreement to the contrary, FMI legal relationship to Roche under this Agreement shall be that of independent contractor.
19.8 | Unenforceable Provisions and Severability |
If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties. However the remainder of this Agreement will remain in full force and effect, provided that the material interests of the Parties are not affected, i.e. the Parties would presumably have concluded this Agreement without the unenforceable provisions.
19.9 | Waiver |
The failure by either Party to require strict performance and/or observance of any obligation, term, provision or condition under this Agreement will neither constitute a waiver thereof nor affect in any way the right of the respective Party to require such performance and/or observance. The waiver by either Party of a breach of any obligation, term, provision or condition hereunder shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term, provision or condition.
19.10 | Appendices |
All Appendices to this Agreement shall form an integral part to this Agreement.
19.11 | Entire Understanding |
This Agreement contains the entire understanding between the Parties hereto with respect to the within subject matter and supersedes any and all prior agreements, understandings and arrangements, whether written or oral.
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19.12 | Amendments |
No amendments of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and signed by both Parties.
19.13 | Invoices |
All invoices that are required or permitted hereunder shall be in writing and sent by FMI to Roche at the following address or other address as Roche may later provide:
F. Hoffmann-La Roche Ltd
Kreditorenbuchhaltung
4070 Basel
Switzerland
19.14 | Notice |
All notices that 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:
if to FMI, to: |
Foundation Medicine, Inc. 150 Second Street Cambridge, MA 02141 Attn: Legal Department Facsimile No.: (617) 418-2201 |
|
if to Roche, to: |
F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 4070 Basel Switzerland Attn: Legal Department Facsimile No.: +41 61 688 13 96 |
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. The effective date of any notice shall be: (a) the date of the addressees receipt, if delivered personally, by courier, or by registered or certified mail; or (b) the date of receipt if received by 5:00 p.m. local time on a business day or, if not, the first business day after receipt, if sent by facsimile.
19.15 | Subcontractors |
Subject to Section 2.1.2, either Party may perform any of its obligations under this Agreement, including under the Tactical Plans and Post Approval Plans, through one or more subcontractors or consultants; provided that (i) such Party remains responsible for the work allocated to, and payment to, such subcontractors and consultants to the same extent it would if it had done such work itself, and such Party shall be liable for any act or omission of such subcontractor and consultant that is a breach of any of such Partys obligations under this Agreement as though the same were a breach by such Party, and the other Party shall have the right to proceed directly
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against such Party without any obligation to first proceed against such subcontractor or consultant; (ii) the subcontractor or consultant undertakes in writing commercially reasonable obligations of confidentiality and non-use regarding Confidential Information, that are substantially the same as those undertaken by the Parties with respect to Confidential Information pursuant to Article 16 hereof; and (iii) the subcontractor or consultant undertakes in writing to assign or exclusively license back (with the right to sublicense) all intellectual property with respect to Product developed in the course of performing any such work under the Tactical Plans and Post Approval Plans to the subcontracting Party. Notwithstanding the above, if a the work to be done by the subcontractor or consultant is material to the performance of a Party under this Agreement, then the Party engaging such subcontractor or consultant shall seek the consent of the other Party, which consent shall not be unreasonably withheld.
19.16 | Force Majeure |
Both Parties shall be excused from the performance of their obligations under this Agreement to the extent that such performance is prevented or delayed by force majeure and the nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse shall be continued so long as the condition constituting force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure means conditions beyond the reasonable control of the Parties, including an act of God, war, civil commotion, terrorist act, labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). Notwithstanding the foregoing, a Party shall not be excused from making payments owed hereunder because of a force majeure affecting such Party.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.
Foundation Medicine, Inc. | ||
/s/ Stefan J. Kafka |
||
Name: | Steven J. Kafka | |
Title: | Chief Operating Officer |
F. Hoffmann-La Roche Ltd | ||||||||
/s/ Jason Coloma |
/s/ Stefan Arnold |
|||||||
Name: | Jason Coloma | Name: | Stefan Arnold | |||||
Title: | Global Head of Venture & Innovation, Roche Partnering | Title: | Head Legal Pharma |
Appendix 1.19
Existing Third Party Rights
[ *** ].
***Confidential Treatment Requested***
Appendix 2.3
Product Specifications
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***Confidential Treatment Requested***
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***Confidential Treatment Requested***
A-2
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***Confidential Treatment Requested***
A-3
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***Confidential Treatment Requested***
A-4
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***Confidential Treatment Requested***
A-5
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***Confidential Treatment Requested***
A-6
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***Confidential Treatment Requested***
A-7
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***Confidential Treatment Requested***
A-8
Exhibit 10.4
EXECUTION COPY
***Text Omitted and Filed Separately with the Securities and Exchange Commission
Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
US Education Collaboration Agreement
This Agreement is entered into with effect as of the Effective Date (as defined below)
by and between
Genentech, Inc.
with an office and place of business at 1 DNA Way, South San Francisco, California 94080 ( Genentech )
and
Foundation Medicine, Inc.
with an office and place of business at 150 Second Street, Cambridge, Massachusetts 02141 ( FMI ) on the other hand.
Table of Contents
1. | Definitions | 5 | ||||||
1.1 | Affiliate | 5 | ||||||
1.2 | Agreement | 5 | ||||||
1.3 | Agreement Term | 5 | ||||||
1.4 | Applicable Law | 5 | ||||||
1.5 | Business Day | 5 | ||||||
1.6 | Calendar Quarter | 5 | ||||||
1.7 | Calendar Year | 5 | ||||||
1.8 | CGP | 5 | ||||||
1.9 | Commercially Reasonable Efforts | 5 | ||||||
1.10 | Confidential Information | 6 | ||||||
1.11 | Control | 6 | ||||||
1.12 | Educational Materials | 6 | ||||||
1.13 | Education Support Program | 6 | ||||||
1.14 | Education Support Working Group | 6 | ||||||
1.15 | Effective Date | 6 | ||||||
1.16 | FDCA | 6 | ||||||
1.17 | FTE | 6 | ||||||
1.18 | FTE Rate | 6 | ||||||
1.19 | Government Agency | 7 | ||||||
1.20 | Healthcare Laws | 7 | ||||||
1.21 | Insolvency Event | 7 | ||||||
1.22 | JOC | 7 | ||||||
1.23 | Know-How | 7 | ||||||
1.24 | Party | 7 | ||||||
1.25 | PREP Team | 7 | ||||||
1.26 | Regulatory Authority | 7 | ||||||
1.27 | Roche Group | 7 | ||||||
1.28 | Tactical Plan | 8 | ||||||
1.29 | Third Party | 8 | ||||||
1.30 | US | 8 | ||||||
1.31 | US$ | 8 | ||||||
1.32 | Additional Definitions | 8 | ||||||
2. | US Education Collaboration | 9 | ||||||
2.1 | Education Support Program | 9 | ||||||
2.2 | Governance | 13 | ||||||
3. | Costs | 15 | ||||||
3.1 | [...***...] | 15 | ||||||
3.2 | Other Costs | 15 | ||||||
3.3 | Disclosure of Payments | 15 | ||||||
4. | Payments | 15 | ||||||
4.1 | Timing of Payments | 15 | ||||||
4.2 | Late Payments | 15 | ||||||
4.3 | Method of Payments | 15 |
***Confidential Treatment Requested***
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5. | Co-Promote Option | 16 | ||||||
6. | Intellectual Property | 16 | ||||||
6.1 | Ownership and Use | 16 | ||||||
6.2 | No Implied Licenses | 17 | ||||||
7. | Representations and Warranties | 17 | ||||||
7.1 | Mutual Representations and Warranties | 17 | ||||||
7.2 | No Other Representations | 18 | ||||||
8. | Liability | 18 | ||||||
9. | Term and Termination | 18 | ||||||
9.1 | Commencement and Term | 18 | ||||||
9.2 | Termination | 18 | ||||||
9.3 | Consequences of Termination | 19 | ||||||
9.4 | Survival | 19 | ||||||
10. | Matters Governed by the Collaboration Agreement | 20 | ||||||
10.1 | Auditing | 20 | ||||||
10.2 | Indemnification | 20 | ||||||
10.3 | Confidentiality | 20 | ||||||
10.4 | Assignment | 20 | ||||||
10.5 | Debarment and Exclusion | 20 | ||||||
11. | Miscellaneous | 20 | ||||||
11.1 | Governing Law | 20 | ||||||
11.2 | Disputes | 20 | ||||||
11.3 | Independent Contractor | 21 | ||||||
11.4 | Unenforceable Provisions and Severability | 21 | ||||||
11.5 | Waiver | 21 | ||||||
11.6 | Appendices | 21 | ||||||
11.7 | Entire Understanding | 21 | ||||||
11.8 | Amendments | 21 | ||||||
11.9 | Invoices | 21 | ||||||
11.10 | Notice | 22 |
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US Education Collaboration Agreement
WHEREAS, FMI has or is developing platforms for use in genomic testing, and has expertise in comprehensive genomic profiling and next generation sequencing technology; and
WHEREAS, Genentech has expertise in the research, development, manufacture and commercialization of pharmaceutical and diagnostic products; and
WHEREAS, Genentech wishes to extend its leadership position in education in personalized healthcare and genetic testing by adding comprehensive genomic profiling to its educational offerings for pathologists and laboratories; and
WHEREAS, Genentech is able to undertake such educational efforts at this time based, in part, on the financial contribution that FMI is providing hereunder; and
WHEREAS, Genentech and FMI want to work together in the United States to educate relevant persons on comprehensive genomic profiling technology; and
WHEREAS, FMI and Genentechs Affiliates F. Hoffmann-La Roche Ltd ( Roche Basel ) and Hoffmann-La Roche Inc. ( Roche US ; Roche Basel and Roche US together referred to as Roche ) are engaged in a series of transactions, including (a) agreements under which Roche will acquire a majority ownership of FMI, (b) an agreement under which Roche will be responsible for the commercialization of certain FMI diagnostic products outside of the United States ( Ex-US Commercialization Agreement ), (c) a term sheet under which FMI and Roche will potentially collaborate on the development of in vitro diagnostic kits, and (d) an agreement under which FMI and Roche will collaborate on the development of platforms for use in molecular information, immunotherapy, circulating tumor DNA, and companion diagnostics ( Collaboration Agreement ), the foregoing agreements and term sheet referred to collectively as the Related Agreements ; and
WHEREAS, FMI and Genentech intend that the governance structure under the Collaboration Agreement will apply to certain matters under this Agreement.
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NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto, intending to be legally bound, do hereby agree as follows:
1. | Definitions |
As used in this Agreement, the following terms, whether used in the singular or plural, shall have the following meanings:
1.1 | Affiliate |
The term Affiliate shall have the meaning set forth in the Collaboration Agreement, provided that references to Roche shall be replaced by references to Genentech.
1.2 | Agreement |
The term Agreement shall mean this document including any and all appendices and amendments to it as may be added and/or amended from time to time in accordance with the provisions of this Agreement.
1.3 | Agreement Term |
The term Agreement Term shall mean the period of time commencing on the Effective Date and expiring five (5) years thereafter, unless such period is extended by the written agreement of the Parties.
1.4 | Applicable Law |
The term Applicable Law shall have the meaning set forth in the Collaboration Agreement.
1.5 | Business Day |
The term Business Day shall mean 9:00 am to 5:00 pm local time on a day other than a Saturday, Sunday or bank or other public or federal holiday in California or Massachusetts.
1.6 | Calendar Quarter |
The term Calendar Quarter shall mean each period of three (3) consecutive calendar months, ending March 31, June 30, September 30 and December 31.
1.7 | Calendar Year |
The term Calendar Year shall mean the period of time beginning on January 1 and ending December 31, except for the first Calendar Year, which shall begin on the Effective Date and end on December 31.
1.8 | CGP |
The term CGP shall mean comprehensive genomic profiling, which may include using next generation sequencing technology.
1.9 | Commercially Reasonable Efforts |
The term Commercially Reasonable Efforts shall mean efforts and resources comparable with the efforts and resources Genentech or FMI, as applicable, devotes to a similar obligation in connection with projects of a similar nature.
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1.10 | Confidential Information |
The term Confidential Information shall have the meaning set forth in the Collaboration Agreement. The terms of this Agreement shall be considered Confidential Information of the Parties.
1.11 | Control |
The term Control shall mean (as an adjective or as a verb including conjugations and variations such as Controls, Controlled or Controlling) (a) with respect to Know-How and intellectual property rights, the possession by a Party of the ability to grant a license or sublicense of such Know-How and intellectual property rights without violating the terms of any agreement or arrangement between such Party and any other party and (b) with respect to proprietary materials, the possession by a Party of the ability to supply such proprietary materials to the other Party as provided herein without violating the terms of any agreement or arrangement between such Party and any other party.
1.12 | Educational Materials |
The term Educational Materials shall mean materials intended to educate healthcare professionals about CGP, which Genentech shall develop for its own use.
1.13 | Education Support Program |
The term Education Support Program shall mean a program under which (a) FMI shall train PREP Team members about CGP; (b) Genentech shall develop the Educational Materials; and (c) PREP Team members, and other representatives of Genentech, shall conduct Educational Activities and perform other activities related to CGP education directed to healthcare professionals.
1.14 | Education Support Working Group |
The term Education Support Working Group or ESWG shall mean the group of persons from both Parties who will handle the day-to-day activities associated with the Education Support Program.
1.15 | Effective Date |
The term Effective Date shall mean the date on which the Collaboration Agreement becomes effective.
1.16 | FDCA |
The term FDCA shall mean the Food, Drug and Cosmetics Act.
1.17 | FTE |
The term FTE shall mean a full-time equivalent person-year, based upon a total of no less than one thousand eight hundred (1,800) working hours per year. In no circumstance can the work of any given person exceed one (1) FTE.
1.18 | FTE Rate |
The term FTE Rate shall mean [ *** ] per FTE on a fully burdened cost basis, which amount shall be subject to increase using the methodology for increasing the FTE Rate under the Collaboration Agreement mutatis mutandis.
***Confidential Treatment Requested***
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1.19 | Government Agency |
The term Government Agency shall mean any department or agency of the US or any US state government with the authority to interpret, regulate under or enforce any Healthcare Laws, which may include a US or US state Regulatory Authority.
1.20 | Healthcare Laws |
The term Healthcare Laws shall mean (a) criminal and civil federal and state fraud and laws including, without limitation, the Civil False Claims Act (31 USC §§ 3729-3733), the Criminal False Claims Act (18 USC § 287), the Anti-Kickback Statute (42 USC § 1320A-7b(b)) and associated regulatory safe harbors (42 CFR § 1001.952), the Physician Self-Referral Law (42 USC § 1395nn), the Criminal Health Care Fraud (18 USC § 1347), the Exclusion Statute (42 USC Section 1320a-7) and the Civil Monetary Penalties Law (42 USC § 1320a-7a); and any US state law equivalents of any of the foregoing; (b) criminal and civil federal and state drug and medical device marketing, advertising and promotional laws, including without limitation the FDCA, and any US state law equivalents thereof; and (c) criminal and civil federal and state consumer protection laws including without limitation Federal Trade Commission Act (15 U.S.C. §§ 41-58); and any US state law equivalents thereof.
1.21 | Insolvency Event |
The term Insolvency Event shall have the meaning set forth in the Collaboration Agreement.
1.22 | JOC |
The term JOC shall mean the joint operating committee described in the Ex-US Commercialization Agreement.
1.23 | Know-How |
The term Know-How shall mean data, knowledge and information, including related to CGP, manufacturing data, toxicological data, pharmacological data, preclinical data, formulations, specifications, quality control testing data.
1.24 | Party |
The term Party shall mean FMI or Genentech, as the case may be, and Parties shall mean FMI and Genentech collectively.
1.25 | PREP Team |
The term PREP Team shall mean Genentechs field-based team of professions referred to as the PREP (Program for Reaching and Educating about Pathology) team, or any other Genentech group performing similar functions, as further described in the Tactical Plan.
1.26 | Regulatory Authority |
The term Regulatory Authority shall have the meaning set forth in the Collaboration Agreement.
1.27 | Roche Group |
The term Roche Group shall have the meaning set forth in the Collaboration Agreement.
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1.28 | Tactical Plan |
The term Tactical Plan shall mean a plan for the [ *** ] that describes the responsibilities of the Parties for implementing the Education Support Program, as further described in Section 2.1.5.
1.29 | Third Party |
The term Third Party shall mean a person or entity other than (a) FMI or any of its Affiliates or (b) a member of the Roche Group.
1.30 | US |
The term US shall mean the United States of America and its territories and possessions.
1.31 | US$ |
The term US$ shall mean US dollars.
1.32 | Additional Definitions |
Each of the following definitions is set forth in the Section of this Agreement indicated below:
Definition |
Section |
|
Bankruptcy Code | 9.3.2 | |
Breaching Party | 9.2.1 | |
Collaboration Agreement | Whereas Clause | |
Educational Activities | 2.1.1 | |
ESWG | 1.14 | |
ESWG Co-Leader | 2.2.1 | |
Ex-US Collaboration Agreement | Whereas Clause | |
FMI Other Materials | 6.1.3 | |
FMI Provided Materials | 6.1.1 | |
FTE Costs | 3.1 | |
Non-Breaching Party | 9.2.1 | |
Other Costs | 3.1 | |
Payment Currency | 4.3 | |
Peremptory Notice Period | 9.2.1 | |
Related Agreements | Whereas Clause | |
Roche | Whereas Clause | |
Roche Basel | Whereas Clause | |
Roche US | Whereas Clause | |
[...***...] | 3.1 | |
Training Activities | 2.1.2 | |
Training Materials | 2.1.2 |
***Confidential Treatment Requested***
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2. | US Education Collaboration |
2.1 | Education Support Program |
2.1.1 | Scope |
Genentech and FMI shall conduct the Education Support Program pursuant to a mutually agreed Tactical Plan under the direction of the Education Support Working Group (also referred to as the ESWG). The purpose of the Education Support Program is for Genentech to provide education support directed to healthcare professionals regarding comprehensive genomic profiling (CGP), using next generation sequencing technology or other technologies that may emerge for CGP ( Educational Activities ).
2.1.2 | Training Activities and Training Materials |
FMI shall provide training to Genentech regarding CGP and other topics, as agreed to by the Parties in the Tactical Plan, subject to the limitations in Section 2.1.7 and other provisions of this Agreement ( Training Activities ). The Training Activities shall take place in the location and on the schedule in the Tactical Plan. As part of the Training Activities, FMI shall provide to Genentech information and materials related to CGP ( Training Materials ). FMI shall prepare the Training Activities and Training Materials with content based on competent and reliable scientific and medical principles. The Training Activities and Training Materials must be non-commercial in tone, focus and content and must make a fair and balanced representation of the positive and negative attributes and uncertainties of CGP. The Training Activities and Training Materials must not incorporate promotional, commercial or marketing messages for FMI or its products including, without limitation, FoundationOne or FoundationOne Heme. Notwithstanding anything to the contrary, in conducting the Training Activities, FMI may use its proprietary platform and CGP testing panels to provide a specific demonstration of how CGP may be performed.
2.1.3 | Educational Materials |
FMI shall provide the Training Materials to Genentech in hardcopy form and in electronic form for use in preparing the Educational Materials. Genentech shall be responsible, in collaboration with FMI, for developing the content and appearance of the Educational Materials, to be used by Genentech as part of the Education Support Program. In preparing the Educational Materials, Genentech will draw upon relevant information included in the Training Activities, upon the relevant expertise of the PREP Team and other Genentech and Roche experts, and upon external sources of scientific and medical information that Roche/Genentech determines to be competent and reliable. The Educational Materials will include only scientific and medical information regarding CGP that Genentech determines to be competent and reliable and will make a fair and balanced presentation of the positive and negative attributes and uncertainties of CGP. Genentech shall provide a copy of the Educational Materials to FMI for review and comment; provided, however, Genentech shall have final decision making authority regarding the Educational Materials.
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2.1.4 | Additional and Updated Training Activities |
The Education Support Working Group shall confer regarding the need, timing and location for (a) additional Training Activities for members who join the PREP Team after the initial Training Activities occur and (b) updated Training Activities for previously trained PREP Team members, based on the emergence of new technology relevant to CGP. FMI and Genentech shall, respectively, use Commercially Reasonable Efforts to provide and attend any such additional or updated Training Activities.
2.1.5 | Tactical Plan |
The Tactical Plan in effect as of the Effective Date is attached as Appendix 2.1.5. Genentech shall update the Tactical Plan [ *** ], on the schedule determined by the Education Support Working Group (and at times as otherwise agreed by the ESWG, including for additional and updated Training Activities, as described in Section 2.1.4), for review and approval by the ESWG. The details included in the Tactical Plan will vary to address the objectives of the Parties, but shall include, as applicable, details regarding (a) the Training Activities, including training materials and timelines; (b) the scope of the Educational Materials and a plan for developing them; (c) the scope and target audiences for the Educational Activities by the PREP Team, using the Educational Materials or otherwise; (d) a budget of estimated [ *** ], and each Partys portion of particular [ *** ] (which portions may vary for particular costs); and (e) information to be shared by the Parties and the timing and means for sharing such information (e.g., through the ESWG or otherwise). For any Educational Activities in a Tactical Plan conducted by PREP Team members, the Parties agree that any activities that Genentech agrees to perform will be reduced pro rata for any period of time that a PREP team position is unstaffed and that an unstaffed position will not be deemed filled until a PREP Team member has attended Training Activities and been trained on the Educational Materials. Information that one Party shares with or provides to the other Party under the Tactical Plan shall be Confidential Information of the sharing or providing Party.
2.1.6 | Regulatory and Compliance Matters |
(a) The Parties intend that (i) the Parties activities will be in all respects compliant with Applicable Laws and (ii) Genentechs Educational Activities under the Tactical Plan will be structured and conducted so as to be educational disease awareness communications disseminated to healthcare professionals that discuss a particular disease or health condition, in order to encourage awareness of signs of the particular disease or heath condition or otherwise provide information to assist in the diagnosis of the particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device, and do not otherwise constitute product advertising or promotional labeling of a drug or medical device.
(b) Each Party shall be solely responsible for matters of compliance with Applicable Laws with respect to its conduct of activities under this Agreement and for interactions with Regulatory Authorities and Government Agencies with respect thereto, as follows: FMI shall be responsible for
***Confidential Treatment Requested***
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its conduct of the Training Activities; Genentech shall be responsible for its preparation of the Educational Materials and the conduct of the Educational Activities; and both Parties will be responsible for the establishment of priorities and tactics in the Tactical Plan and for discussions and sharing of information at the Education Support Working Group and otherwise between the Parties under this Agreement. If either Party receives a communication from a Regulatory Authority or Government Agency that its activities under this Agreement may violate or have violated any Applicable Law or regulation, including any notice of claim, demand, suit, investigation or proceeding that relates or may reasonably relate to any such activities, such Party shall promptly share that communication with the other Party, and the Parties shall confer on an appropriate response, provided that (i) the Party receiving the communication shall remain free to take any or no action in response to such communication including, without limitation, terminating this Agreement under Section 9.2.2 and (ii) if both Parties are responsible for any of the activities under this Agreement (as specified in this Section 2.1.6(b)) potentially relevant to such claim, demand, suit, investigation or proceeding, then the Parties shall discuss in good faith how to respond to it and how to handle it in an efficient manner.
2.1.7 | Limitations on Activities |
The Parties acknowledge and agree to the following:
(a) This Agreement (individually or together with the Related Agreements) is not intended for the promotion in the US by Genentech of any Genentech products or any FMI products or services (including, without limitation, FoundationOne or FoundationOne Heme) or for the promotion in the US by FMI of any Genentech products or any FMI products or services (including, without limitation, FoundationOne or FoundationOne Heme), provided that nothing in the foregoing or elsewhere in this Agreement or the Related Agreements shall limit each Party in promoting its own products or services separate from and outside the scope of this Agreement and the Related Agreements.
(b) Neither Party shall, under this Agreement, provide to or discuss with the other Party any of such Partys promotional strategies, plans or tactics for its products or services. Notwithstanding the foregoing, the Parties may discuss any activities of the PREP Team.
(c) Genentech and its agents shall not recommend or mention FMI products or services (including, without limitation, FoundationOne or FoundationOne Heme) in the course of Educational Activities and will not refer any audiences to FMI or its products or services. The Educational Materials and educational messaging that Genentech uses in the Educational Activities shall not include any branding or references to either Partys products or services. Notwithstanding the foregoing, company level branding (e.g., a Partys logo) may be included as required by Applicable Law or accepted industry codes or practices, or for purposes of corporate transparency. Without limiting the foregoing, any such branding shall be subject to the agreement of the Parties through the Education Support Working Group. Without limiting the generality of the foregoing, any promotion, recommendation, or referral by either Party of or to the other or the others products or services in the US may only occur pursuant to a separate agreement or an amendment to this Agreement.
(d) The Parties acknowledge that, currently, reports for patients generated through FoundationOne include mention of Genentech products as being approved to treat tumors with
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particular types of mutations identified in such patients tumors in the FoundationOne test and the same may be done in the future for the FoundationOne Heme test on the same principles. The Parties do not intend, through this Agreement or any Related Agreement, to compensate, encourage or incentivize FMI to make, change or prioritize such mentions of Genentech products in FoundationOne or as part of any other FMI product or services. FMI covenants that it will not, by reason of its relationships with Genentech or Roche under this Agreement or the Related Agreements, change its practices in how it promotes, advertises, offers or provides FoundationOne, FoundationOne Heme or any other product or service that it offers (including, without limitation, by changing how Genentech products are presented or mentioned in any such product or service report or how any potential association between a reported mutation and a Genentech product is presented or mentioned).
2.1.8 | Diligence and Activities |
The Parties shall use Commercially Reasonable Efforts to perform their respective activities under the Tactical Plan and as otherwise contemplated by this Agreement. The Parties shall perform all activities under this Agreement (a) in a professional manner; (b) in conformance with the level or care and skill ordinarily exercised by other professional institutions in similar circumstances; and (c) in compliance with Applicable Law.
2.1.9 | Third Party Contractors and Affiliates |
Neither Party shall have the right to subcontract to Third Parties the work for which it is responsible under the Tactical Plan or otherwise under this Agreement, except for activities customarily subcontracted by such Party, including the preparation or production of Training Materials or Educational Materials and planning or coordination of Training Activities or Educational Activities. For clarity, none of the following activities may be subcontracted without the other Partys prior written consent to subcontract (which may be provided by email to the subcontracting Partys ESWG Co-Leader): (a) for Genentech, (i) membership on, and participation in discussions and decision making of, the ESWG; (ii) PREP Team attendance at Training Activities; (iii) oversight of preparation of, and final review and approval of, Educational Materials; (iv) educational calls including CGP education that are made by PREP Team members on healthcare professionals, laboratories and others included within the target audience, as described in the Tactical Plan; (v) oversight of preparation of, and final review and approval of, materials for unbranded speaker programs including CGP education, as described in the Tactical Plan and included in Educational Activities; (vi) on-site presence for and oversight of unbranded speaker programs including CGP education, as described in the Tactical Plan and included in Educational Activities; (vii) information-sharing as required under the Tactical Plan; and (viii) discussions with FMI on communications from Government Agencies under Section 2.1.6(b) and (b) for FMI, (i) membership on, and participation in discussions and decision making of, the ESWG; (ii) oversight of preparation of, and final review and approval of, Training Materials; (iii) conduct of Training Activities; (iv) information-sharing as required under the Tactical Plan; and (v) discussions with Genentech on communications from Government Agencies under Section 2.1.6(b). Each Party shall have the right to perform its obligations under this Agreement through its Affiliates. Each Party shall remain fully responsible for and liable to the other Party for the performance of activities under this Agreement by such Third Parties or Affiliates.
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2.2 | Governance |
2.2.1 | Establishment of the ESWG |
The Parties shall establish the Education Support Working Group within [ *** ] after the Effective Date to operationalize the Education Support Program. The ESWG shall be composed of at least two (2), but no more than three (3) representatives designated by each Party (and the Parties need not have the same number of representatives). The representatives shall be appropriate (in terms of their seniority, availability, function in their respective organizations, training and experience) for the activities for which the ESWG is responsible. Each Party shall designate one of its representatives as its primary contact for ESWG matters (such Partys ESWG Co-Leader ). A Party may replace any or all of its representatives (and designated ESWG Co-Leader) at any time by informing the other Partys ESWG Co-Leader in advance, in writing (which may be by email).
2.2.2 | Responsibilities of the ESWG |
The Education Support Working Group shall:
(a) review and approve [ *** ] Tactical Plans and revisions to the Tactical Plans, each of which [ *** ] plan and revision Genentech shall prepare in accordance with Section 2.1.5;
(b) serve as a forum for coordinating the Parties efforts to carry out the Tactical Plan;
(c) monitor the progress of activities under the Tactical Plan and discuss any obstacles or delays with regard to achieving the timelines set forth therein;
(d) within [ *** ] following the end of each [ *** ] in which [ *** ] are incurred by a Party, coordinate, and/or be the primary conduit for, providing to the other Party a good faith estimate of such incurred [ *** ] (which may differ from the actual invoice) in writing (which may be by email);
(e) provide reports and other information to the JOC regarding activities under the Tactical Plan, as requested by the JOC;
(f) coordinate, and/or be the primary conduit for, the transfer of information between the Parties, as required by the Tactical Plan; and
(g) perform other responsibilities as may be assigned to the ESWG in or pursuant to this Agreement or as may be otherwise agreed by the Parties in writing.
2.2.3 | Decision Making Authority of the ESWG |
With respect to the responsibilities of the Education Support Working Group, each Party shall have one (1) collective vote in all decisions, and the Parties shall attempt to make decisions by reaching agreement. Except with respect to matters for which one Party expressly has final decision making authority (e.g., Section 2.1.2 with respect to Educational Materials), if the ESWG cannot reach agreement within [ *** ]. Genentech acknowledges that it will be represented by Roche on the JOC. The ESWG has no authority to amend, or to waive compliance with, any provisions of this Agreement.
***Confidential Treatment Requested***
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2.2.4 | ESWG Co-Leaders |
Genentechs ESWG Co-Leader (or its designee) shall be responsible for the following: (a) scheduling Education Support Working Group meetings and setting meeting agendas; (b) calling emergency ESWG meetings; and (c) any additional responsibilities specified in the Agreement; provided, however, FMIs Co-Leader has the right to schedule meetings, raise matters for discussion and put matters to a vote.
2.2.5 | Meetings; Attendees |
Once established, the Education Support Working Group shall meet at least once each [ *** ] (unless otherwise agreed by the Parties), and shall meet at such other times as deemed appropriate by the ESWG. The ESWG may meet in person or via teleconference, video conference or the like, provided that at least [ *** ] shall be held in person, unless otherwise agreed by the Parties. Each Party shall bear the expense of its respective representatives participation in ESWG meetings. If a Partys representative (including its ESWG Co-Leader) is unable to attend a given meeting, such Party may designate a knowledgeable alternate to attend such meeting and perform the functions of such representative. Each Party may, subject to providing prior notice to the other Partys ESWG Co-Leader (which may be by email), invite a reasonable number of non-voting employees, consultants or advisors to attend ESWG meetings, provided that such invitees are bound by confidentiality and non-use obligations reasonably similar to the Parties obligations under this Agreement. In addition to formal meetings, the ESWG representatives shall communicate as necessary to ensure the appropriate direction of the Education Support Program.
2.2.6 | Minutes; Other Documentation of Decisions |
Promptly after the Education Support Working Group is established, it shall hold an organizational meeting to define the ESWGs operating procedures, including for establishing agendas and preparing and approving minutes. Genentech shall be responsible for keeping minutes of ESWG meetings that record in writing all decisions made, action items assigned or completed and other appropriate matters. Meeting minutes shall be sent to both Parties promptly after a meeting for review, comment and approval by each Party. A decision that may be made at a ESWG meeting may also be made, without a meeting, if such decision is agreed to in writing (including by email) by each Partys ESWG Co-Leader (or its designee), provided that each Partys writing clearly indicates that such decision is a formal decision by such Partys ESWG Co-Leader. Any modifications to the Tactical Plan approved at a ESWG meeting (in accordance with the decision making authority provisions of Section 2.2.3) shall constitute an amendment to such Tactical Plan upon approval by both Parties of the meeting minutes related thereto.
2.2.7 | Term of ESWG Operations |
The Education Support Working Group shall exist during the Agreement Term.
***Confidential Treatment Requested***
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3. | Costs |
3.1 | [...***...] |
In accordance with the Tactical Plan, the Parties shall share [ *** ]. FMI shall reimburse Genentech for [ *** ].
3.2 | Other Costs |
Unless otherwise expressly agreed in the Tactical Plan, each Party shall bear the costs it incurs in connection with the Training Activities and/or Educational Activities, including transportation, meals, lodging and the time necessary for representatives to prepare for and attend the Training Activities. Genentech shall be solely responsible for the costs of producing the Educational Materials.
3.3 | Disclosure of Payments |
Each Party acknowledges that the other Party may be obligated to disclose financial arrangements made with third parties to carry out certain activities under the Tactical Plan, including all fees, payments and transfers of value, as may be advisable or required under Applicable Law, including the US Sunshine Act.
4. | Payments |
4.1 | Timing of Payments |
FMI shall pay its portion of the [ *** ] in arrears. Each [ *** ], Genentech shall invoice FMI for its portion of actual [ *** ] incurred in the previous [ *** ]. Invoices shall be payable within [ *** ] after receipt by FMI of an invoice from Genentech.
4.2 | Late Payments |
Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at [ *** ] above the average one-month Euro Interbank Offered Rate (EURIBOR), as reported by Reuters from time to time, calculated on the number of days such payment is overdue.
4.3 | Method of Payments |
All amounts payable hereunder shall be paid in US dollars (the Payment Currency ) to account(s) designated by Genentech.
***Confidential Treatment Requested***
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5. | Co-Promote Option |
If FMI seeks to promote a CDx (as defined in the Collaboration Agreement) for a Genentech therapeutic in the US, then FMI shall first notify Genentech in writing and offer to Genentech [ *** ]. Genentech shall have [ *** ] from the receipt of such notice from FMI to provide FMI with [ *** ]. If at the end of such [ *** ] period Genentech has not provided FMI with written notice [ *** ], then FMI shall have no further obligation with respect to [ *** ]. If Genentech properly [ *** ], then the Parties shall [ *** ]. Notwithstanding the foregoing, FMI shall have the right to promote such product alone, at any time during such [ *** ], and following such [ *** ] period, in combination with one or more Third Parties. In addition to the provisions surviving under Section 9.4, this Section shall survive the expiration or termination of this Agreement for so long as the CDx Development Program (as defined in the Collaboration Agreement) remains in effect, except in the case of termination by FMI for Genentechs material breach.
6. | Intellectual Property |
6.1 | Ownership and Use |
6.1.1 | FMI Provided Materials |
In connection with the Training Activities (or otherwise under this Agreement), FMI may provide to Genentech certain Know-How and other materials ( FMI Provided Materials ). FMI shall only provide FMI Provided Materials to Genentech that FMI Controls and otherwise has all necessary rights to (a) provide such FMI Provided Materials to Genentech and (b) grant the license under Section 6.1.2 to Genentech and its Affiliates. FMI possesses (or may possess) proprietary rights (e.g., copyrights) in certain of the FMI Provided Materials and, as between the Parties (subject to such license to Genentech), FMI shall solely own all right, title and interest in and to the FMI Provided Materials. For the avoidance of doubt, certain FMI Provided Materials may be subject to Third Party proprietary rights (e.g., copyrights) and Genentechs use thereof is subject to such rights. At the time FMI provides to Genentech any FMI Provided Materials that include content subject to the proprietary rights of a Third Party, FMI shall identify in writing such Third Party content and the identity of such Third Party.
6.1.2 | License Grant to Genentech; Educational Materials |
FMI hereby grants to Genentech and its Affiliates a non-exclusive, perpetual, fully paid-up, irrevocable, non-sublicensable, worldwide license to incorporate FMI Provided Materials in the Educational Materials and similar materials and to otherwise use the FMI Provided Materials in the Educational Activities and similar activities, including the right to create, reproduce and distribute the Educational Materials and similar materials and to authorize others to do so on its behalf, in each case, subject to copyrights or similar rights of Third Parties; provided however, such license shall not include any right or license under FMIs intellectual property rights to FMIs corporate or product trade names or trademarks. As between the Parties, Genentech shall solely own all right, title and interest in and to the Educational Materials and similar materials (excluding FMI Provided Materials and FMI Other Materials), and Genentech may, and may have any authorized designee acting on behalf of Genentech, use the Educational Materials and similar materials for Genentechs own purposes, including outside the scope of this Agreement.
***Confidential Treatment Requested***
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6.1.3 | License Grant to FMI; FMI Other Materials |
Genentech hereby grants to FMI and its Affiliates a non-exclusive, perpetual, fully paid-up, irrevocable, non-sublicensable, worldwide license to incorporate Genentech originated content included in the Educational Materials in materials to be used by FMI for its own purposes ( FMI Other Materials ), including the right to create, reproduce and distribute FMI Other Materials including such content and to authorize others to do so on its behalf, in each case, subject to copyrights or similar rights of Third Parties; provided, however such license shall not include any right or license under Genentechs intellectual property rights to Genentechs corporate or product trade names or trademarks. FMI shall use trade dress (fonts, color scheme, design attributes) in connection with the FMI Other Materials sufficiently different from the trade dress of the Educational Materials so as not to create any confusion, or mislead a reasonable person, as to whether Genentech is the owner or source of the FMI Other Materials. Prior to the initial instance of reproduction or distribution of FMI Other Materials to Third Parties, FMI shall provide copies of such FMI Other Materials to Genentech. For the avoidance of doubt, certain Educational Materials may be subject to Third Party proprietary rights (e.g., copyrights) and FMIs use thereof is subject to such rights. At the time Genentech provides to FMI any Educational Materials that include content subject to the proprietary rights of a Third Party (other than such content that was provided by FMI to Genentech), Genentech shall identify in writing such Third Party content and the identity of such Third Party.
6.2 | No Implied Licenses |
Except as specifically set forth herein, this Agreement shall not be construed as (a) giving a Party any license, right, title, interest in or ownership to the Confidential Information or other proprietary information or materials of the other Party; (b) granting to a Party any license or right under any intellectual property rights of the other Party; or (c) representing any commitment by either Party to enter into any additional agreement, by implication or otherwise.
7. | Representations and Warranties |
7.1 | Mutual Representations and Warranties |
FMI and Genentech each represent and warrant that it:
(a) has all requisite power and authority to enter into and perform its obligations under this Agreement;
(b) has no outstanding agreement or obligation that is in conflict with any of the provisions of this Agreement or that would preclude its personnel from complying with the provisions hereof; and
(c) will perform all activities under this Agreement (i) in a professional manner, (ii) in conformance with the level or care and skill ordinarily exercised by other professional institutions in similar circumstances, and (iii) in compliance with Applicable Law.
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7.2 | No Other Representations |
EXCEPT AS OTHERWISE PROVIDED IN THIS AGREEMENT AND THE RELATED AGREEMENTS BEING ENTERED INTO BY THE PARTIES AT THIS TIME, THE FOREGOING REPRESENTATIONS AND WARRANTIES ARE IN LIEU OF ALL OTHER REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF PRODUCTS.
8. | Liability |
IN NO EVENT SHALL EITHER FMI OR GENENTECH BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT BASED ON CONTRACT, TORT OR ANY OTHER LEGAL THEORY.
9. | Term and Termination |
9.1 | Commencement and Term |
This Agreement shall commence upon the Effective Date, and unless terminated sooner as provided in Article 9, continue for the Agreement Term.
9.2 | Termination |
9.2.1 | Termination for Breach |
A Party ( Non-Breaching Party ) shall have the right to terminate this Agreement in its entirety in the event the other Party ( Breaching Party ) is in breach of any of its material obligations under this Agreement. The Non-Breaching Party shall provide written notice to the Breaching Party, which notice shall identify the breach. The Breaching Party shall have a period of [ *** ] after such written notice is provided ( Peremptory Notice Period ) to cure such breach. If the Breaching Party has a bona fide dispute as to whether such breach occurred or has been cured, it will so notify the Non-Breaching Party, and the expiration of the Peremptory Notice Period shall be tolled until such dispute is resolved pursuant to Section 11.2. Upon a determination of breach or failure to cure, the Breaching Party may have the remainder of the Peremptory Notice Period to cure such breach. If such breach is not cured within the Peremptory Notice Period, then absent withdrawal of the Non-Breaching Partys request for termination, this Agreement shall terminate effective as of the expiration of the Peremptory Notice Period.
9.2.2 | Termination for Regulatory, Compliance and Other Matters |
A Party shall have the right to terminate this Agreement on [ *** ] notice and to immediately suspend any affected activities under the Agreement, if (a) it receives a communication from a Government Agency to the effect that one or more activities by either or both Parties under the
***Confidential Treatment Requested***
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Agreement violates Applicable Law including, without limitation, any Healthcare Law, and regulations promulgated under the foregoing laws; (b) a Government Agency promulgates a regulation during the Agreement Term that is or would be violated by one or more activities by either or both Parties under the Agreement; (c) a Government Agency issues an opinion, guidance or interpretation during the Agreement Term that reasonably indicates that it is the position of such Government Agency that activities of the nature of one or more activities by either or both Parties under the Agreement violates or would violate Applicable Law including, without limitation any Healthcare Law, and regulations promulgated under any such laws; or (d) such Party has a right to terminate the Agreement under Section 2.2.3.
9.2.3 | Termination for Insolvency |
A Party shall have the right to terminate this Agreement, if the other Party incurs an Insolvency Event; provided, however, in the case of any involuntary bankruptcy proceeding, such right to terminate shall only become effective if the Party that incurs the Insolvency Event consents to the involuntary bankruptcy or such proceeding is not dismissed within [ *** ] after the filing thereof.
9.2.4 | Termination Without a Cause |
Each Party shall have the right to terminate this Agreement in its entirety, in its sole discretion, during the first Calendar Year of the Agreement upon six (6) months prior written notice to the other Party and thereafter upon three (3) months prior written notice to the other Party.
9.3 | Consequences of Termination |
9.3.1 | Accrued Rights and Obligations |
Except as otherwise expressly provided in this Agreement, termination of this Agreement shall not affect the rights and obligations of the Parties that accrued prior to the effective date of such termination, including any obligation that FMI has to make payments to Genentech that are due and payable prior to the effective date of termination. Any right that a Party has to terminate this Agreement, and any rights that such Party has under Article 9, shall be in addition to and not in lieu of all other rights or remedies that such Party may have at law or in equity or otherwise, including rights under the Bankruptcy Code.
9.3.2 | Bankruptcy |
All licenses (and to the extent applicable rights) granted under or pursuant to this Agreement by FMI to Genentech are, and shall otherwise be deemed to be, for purposes of Section 365(n) of Title 11, US Code ( Bankruptcy Code ) licenses of rights to intellectual property as defined under Section 101 of the Bankruptcy Code.
9.4 | Survival |
Article 6 (Intellectual Property), Article 7 (Representations and Warranties), Article 8 (Liability), Article 9 (Term and Termination), Article 10 (Matters Governed by the Collaboration Agreement), and Article 11 (Miscellaneous) (to the extent applicable) shall survive any expiration or termination of this Agreement for any reason.
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10. | Matters Governed by the Collaboration Agreement |
10.1 | Auditing |
Except as otherwise specified herein, the auditing provisions of the Collaboration Agreement shall apply any payments made by one Party to the other Party under this Agreement (e.g., with respect to payments by FMI to Genentech for FTE Costs) mutatis mutandis .
10.2 | Indemnification |
Except as otherwise specified herein, the indemnification provisions of the Collaboration Agreement shall apply to this Agreement mutatis mutandis .
10.3 | Confidentiality |
Except as otherwise specified herein, the confidentiality provisions of the Collaboration Agreement shall apply to any Confidential Information obtained by a Party or its Affiliates under this Agreement mutatis mutandis .
10.4 | Assignment |
Except as otherwise specified herein, the assignment provisions of the Collaboration Agreement shall apply to this Agreement mutatis mutandis .
10.5 | Debarment and Exclusion |
Except as otherwise specified herein, the Parties representations, warranties and covenants with respect to debarment and exclusion in the Collaboration Agreement shall apply to this Agreement mutatis mutandis .
11. | Miscellaneous |
11.1 | Governing Law |
This Agreement shall be governed by and construed in accordance with the laws of New York, US, without reference to its conflict of laws principles, and shall not be governed by the United Nations Convention of International Contracts on the Sale of Goods (the Vienna Convention).
11.2 | Disputes |
Unless otherwise set forth in this Agreement (e.g., Section 2.2.3), in the event of any dispute in connection with this Agreement, such dispute shall be referred to the respective executive officers of the Parties designated below or their designees, for good faith negotiations attempting to resolve the dispute. The designated executive officers are as follows:
For FMI: CEO
For Genentech: Head of Roche Partnering
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Should the Parties fail to agree within the time period set forth in the Collaboration Agreement for dispute resolution by the Parties, except as otherwise specified herein, the arbitration provisions of the Collaboration Agreement shall apply to disputes arising under this Agreement mutatis mutandis .
11.3 | Independent Contractor |
No employee or representative of either Party shall have any authority to bind or obligate the other Party to this Agreement for any sum or in any manner whatsoever or to create or impose any contractual or other liability on the other Party without said Partys prior written approval. For all purposes, and notwithstanding any other provision of this Agreement to the contrary, FMI legal relationship to Genentech under this Agreement shall be that of independent contractor.
11.4 | Unenforceable Provisions and Severability |
If any of the provisions of this Agreement are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties. However the remainder of this Agreement will remain in full force and effect, provided that the material interests of the Parties are not affected, i.e., the Parties would presumably have concluded this Agreement without the unenforceable provisions.
11.5 | Waiver |
The failure by either Party to require strict performance and/or observance of any obligation, term, provision or condition under this Agreement will neither constitute a waiver thereof nor affect in any way the right of the respective Party to require such performance and/or observance. The waiver by either Party of a breach of any obligation, term, provision or condition hereunder shall not constitute a waiver of any subsequent breach thereof or of any other obligation, term, provision or condition.
11.6 | Appendices |
All Appendices to this Agreement shall form an integral part to this Agreement.
11.7 | Entire Understanding |
This Agreement contains the entire understanding between the Parties hereto with respect to the within subject matter and supersedes any and all prior agreements, understandings and arrangements, whether written or oral.
11.8 | Amendments |
No amendments of the terms and conditions of this Agreement shall be binding upon either Party hereto unless in writing and signed by both Parties.
11.9 | Invoices |
All invoices that are required or permitted hereunder shall be in writing and sent by Genentech to FMI by email at the following address or other address as FMI may later provide:
Foundation Medicine, Inc.
ap@foundationmedicine.com
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11.10 | Notice |
All notices that 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:
if to FMI, to: |
Foundation Medicine, Inc. 150 Second Street Cambridge, Massachusetts 02141 Attn: Legal Department Facsimile No.: +1 617-418-2201 |
|
if to Genentech, to: |
Genentech, Inc. 1 DNA Way Attn: Corporate Secretary Facsimile No.: +1 650-467-9146 |
|
and: |
Genentech, Inc. 1 DNA Way Attn: Global Head, Alliance and Asset Management Facsimile No.: +1 650-467-3294 |
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.
[Signature Page Follows]
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IN WITNESS WHEREOF, the Parties have entered into this Agreement as of the Effective Date.
Foundation Medicine, Inc. | ||
/s/ Steven J. Kafka |
||
Name: | Steven J. Kafka | |
Title: | Chief Operating Officer |
Genentech, Inc. | ||
/s/ Ian T. Clark |
||
Name: | Ian T. Clark | |
Title: | Chief Executive Officer |
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Appendix 2.1.5
Tactical Plan
US Education Collaboration Agreement
2015 Tactical Plan
Capitalized terms used in this Tactical Plan shall have the meaning given them in the US Education Collaboration Agreement unless otherwise defined herein.
Term: Effective Date to December 31, 2015
A. Training Activities
[ *** ].
B. Development of Educational Materials
[ *** ].
C. PREP Educational Activities
[ *** ].
D. Educational Speaker Programs
[ *** ].
E. Information Sharing
[ *** ].
F. Costs and Compensation
[ *** ].
G. [ *** ] Tactical Plan
The Parties, through the ESWG, will consider whether to incorporate a CGP education effectiveness metric to be tracked and assessed for the [ *** ] tactical plans and/or subsequent tactical plans as they develop more insight and experience with this collaboration.
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A-1
Exhibit 10.5
EXECUTION COPY
***Text Omitted and Filed Separately with the Securities and Exchange Commission
Confidential Treatment Requested Under
17 C.F.R. Sections 200.80(b)(4) and 240.24b-2
Foundation Medicine/Roche
Binding Term Sheet for an In Vitro Diagnostics Collaboration
This summary of terms (this Binding Term Sheet ) between Foundation Medicine, Inc. ( FMI ) and F. Hoffmann-La Roche Ltd ( Roche ) (each a Party , and collectively the Parties ), sets forth certain terms and conditions relating to an in vitro diagnostics ( IVD ) collaboration between the Parties ( IVD Collaboration ), which will include transactions regarding the worldwide development and commercialization of IVD versions of FMIs products and services.
It is expressly agreed that this Binding Term Sheet shall be binding upon the Parties as of the Effective Date and shall only be superseded if the Parties execute a more definitive agreement ( Definitive Agreement ) reflecting additional detail with respect to the terms and conditions set forth herein, as well as any other terms and conditions as the Parties may mutually agree. The completion and execution of the Definitive Agreement shall be subject to the approval of the management and/or Boards of Directors of both Parties, as applicable.
Capitalized terms used herein shall have the meanings provided above or as defined below.
Affiliates | The Parties recognize that Roche operates as a network of affiliated companies. Accordingly, the Definitive Agreement may be entered into by one or more Roche affiliates and Roches rights and obligations under the Definitive Agreement may be performed by or extended to multiple Roche affiliates. Roche shall ensure that each such Roche affiliate complies with the terms and conditions of the Definitive Agreement. For the avoidance of doubt, Roche and FMI are not an affiliate of one another for purposes of this Binding Term Sheet. | |
Confidentiality | The terms and conditions of this Binding Term Sheet, as well as any Information (as defined in the confidentiality agreement entered into by a Roche affiliate and FMI on June 9, 2014 (the Existing CDA )) disclosed by one Party to the other Party in connection with the transactions contemplated by this Binding Term Sheet and negotiations related thereto are subject to the Existing CDA. | |
Binding Term Sheet Term and Termination | This Binding Term Sheet shall commence on the Effective Date and remain in full force and effect until terminated by mutual written agreement duly executed by the Parties (the Binding Term Sheet |
Term ). The terms and conditions set forth in the sections entitled Confidentiality, Roche MFN and Miscellaneous shall survive any termination of this Binding Term Sheet. For purposes of this Binding Term Sheet, Effective Date shall have the meaning set forth in the Collaboration Agreement. | ||
Efforts to Negotiate and Enter into Agreement |
The Parties will use commercially reasonable efforts to (i) negotiate, in good faith, the terms of the Definitive Agreement, which shall reflect additional detail with respect to the terms and conditions set forth in this Binding Term Sheet, as well as any other terms and conditions as the Parties may mutually agree, and (ii) enter into such Definitive Agreement as soon as practicable after the Effective Date, but no later than one (1) year after the closing of a series of transactions between the Parties and/or their respective affiliates entered contemporaneously on the Effective Date (which period may be extended by mutual written agreement of the Parties).
In addition to the foregoing, FMI shall [ *** ] if Roche so requests, enter into the Definitive Agreement with Roche no later than [ *** ] thereafter on the terms set forth herein, including any terms required by the terms and conditions set forth in the section entitled Roche MFN. If FMI and Roche are unable to agree to any additional terms of such Definitive Agreement within such [ *** ] period, then the Parties shall refer such dispute to the JMC (as defined below), which shall have [ *** ] to resolve such dispute by consensus. If there are any matters not resolved by the JMC within such [ *** ] period, then the Parties shall each select and agree upon a mutually acceptable independent third party expert who is neutral, disinterested and impartial, and has significant relevant experience in the development and commercialization of diagnostic products (each, an Expert ). Each Expert shall within [ *** ] select a third Expert to form a panel of three (3) Experts ( Panel ). The date on which such Panel is selected will be the Arbitration Commencement Date . Each Party shall within [ *** ] following the Arbitration Commencement Date prepare and deliver to both the Panel and the other Party its proposed terms that have not been agreed (collectively, the Arbitration Offer ) to resolve the disputed matter and a memorandum (the Supporting Memorandum ) in support thereof; provided that such Arbitration Offer shall be on the same or substantially similar terms as the last offer made by such Party to the other Party during the initial [ *** ] period. The Panel will also be provided with a copy of this Binding Term Sheet and any agreements that are relevant to interpretation of the terms and conditions set forth in the section entitled Roche MFN. Within |
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[ *** ] after receipt of the other Partys Supporting Memorandum, each Party may submit to the Panel (with a copy to the other Party) a rebuttal to the other Partys Supporting Memorandum (a Rebuttal ), which may include a revision, marked to show changes, of either Partys proposed terms. Neither Party may have communications (either written or oral) with the Panel other than for the sole purpose of engaging the Panel or as expressly permitted in this section. Within [ *** ] after the Panels receipt of each Partys Rebuttal (or the expiration of the period for the Parties to submit a Rebuttal, if earlier), the Panel will select, between the proposals provided by the Parties, the proposal that the Panel believes most accurately reflects an equitable result for FMI and Roche based on the requirements of this Binding Term Sheet (the Selected Terms ). The Panel shall not have the authority to modify a proposal initially submitted by a Party. The decision of the Panel shall be the sole, exclusive and binding remedy and the Selected Terms shall automatically become incorporated into the Definitive Agreement and such Definitive Agreement shall automatically become a binding and enforceable agreement between the Parties. The Panel will have reasonable discretion to request additional information, hold a hearing, and extend the time frame for reaching a decision regarding the dispute at issue. The Panels fees and expenses will be paid by the Party whose proposal is not selected by the Panel. Each Party will bear and pay its own expenses incurred in connection with any proceedings under this section. | ||
Diligence | The Parties will exercise commercially reasonable efforts in performing their obligations under the IVD Collaboration, including in connection with the evaluation of proposals to develop and commercialize IVD Kit Products (as defined below). | |
Governance; Dispute Resolution | The responsibilities of the Joint Research and Development Committee ( JRDC ) and Joint Management Committee ( JMC ) established by the Collaboration Agreement (as defined below) shall be extended to apply to the IVD Collaboration. In furtherance of the foregoing, the provisions of Article 6 of the Collaboration Agreement are incorporated herein and shall apply mutatis mutandis ; provided that Sections 6.1.2, 6.1.5.1, 6.1.5.2, 6.1.7, 6.3, and 6.7 shall not apply to this Binding Term Sheet or any activities under the IVD Collaboration. For the avoidance of doubt, (i) the JRDCs responsibilities shall include evaluating in good faith proposals to develop and commercialize IVD Kit Products and overseeing the IVD Development Working Group (as defined below), (ii) each of the JRDC and JMC will make decisions related to the IVD Collaboration by consensus of the Parties, (iii) unresolved issues at the |
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JRDC will be addressed by the JMC, (iv) unresolved issues at the JMC will be addressed by the CEOs of Roche and FMI (or their designees), and (v) issues not resolved by the CEOs shall be resolved by [ *** ]. For clarity, for purposes of the foregoing governance and dispute resolution terms and conditions, but subject to the terms and conditions set forth in the section entitled Roche MFN below, (a) neither Party may unilaterally exercise deciding authority to compel the other Party to pursue development and commercialization of any IVD Kit Product (including any Roche IVD Kit Product), and (b) any such development and commercialization of any such IVD Kit Product (or Roche IVD Kit Product) under the IVD Collaboration shall require mutual agreement of the Parties.
For the purposes of this Binding Term Sheet, Collaboration Agreement means that certain Collaboration Agreement entered into between the Parties concurrently with this Binding Term Sheet relating to the use of FMIs molecular information platform and the development of immunotherapy, circulating tumor DNA and companion diagnostics platforms. |
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Working Group |
The JRDC shall establish a working group (the IVD Development Working Group ) to oversee the activities contemplated under each IVD Agreement.
The IVD Development Working Group will make recommendations to the JRDC regarding planned IVD Collaboration activities between Roche and FMI and related budgets. Further authorities might be granted to the IVD Development Working Group by the JRDC. |
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Definitive Agreement/IVD Agreement Term and Termination | The term of the Definitive Agreement ( Definitive Agreement Term ) shall be a period commencing on the effective date of the Definitive Agreement and, unless earlier terminated by the Parties in accordance with the terms of the Definitive Agreement, expiring five (5) years from such effective date, unless extended by Roche for additional two (2) year periods of time during any period of time in which the Aggregate Ownership Percentage (as defined in the Investor Rights Agreement) of Roche and its affiliates is at least fifty percent (50.1%) (it being understood that this requirement is subject to Section 4.04 of the Investor Rights Agreement). For purposes of this Binding Term Sheet, the Definitive Agreement and each IVD Agreement, (i) Transaction Agreement means that certain Transaction Agreement entered into between Roche and FMI concurrently with the execution of this Binding Term Sheet (as amended from time to time) and (ii) Investor Rights Agreement shall have the meaning set forth in the Transaction Agreement. |
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Notwithstanding the Definitive Agreement Term, if the Parties execute an agreement specifically governing the development, manufacture, use and commercialization of any IVD Kit Product (defined below) (each such agreement, an IVD Agreement ), the initial term of each such IVD Agreement with respect to such IVD Kit Product shall be five (5) years (the Initial IVD Agreement Term ) from the date of execution thereof. Such Initial IVD Agreement Term may be extended by Roche, at its option, for one additional three (3) year period during any period of time in which the Aggregate Ownership Percentage (as defined in the Investor Rights Agreement) of Roche and its affiliates is at least fifty percent (50.1%) (it being understood that this requirement is subject to Section 4.04 of the Investor Rights Agreement)(the Initial IVD Agreement Term and any such extension are together referred to as the IVD Agreement Term ). For clarity, the IVD Agreement Term shall be determined on an IVD Kit Product-by-IVD Kit Product basis.
For the avoidance of doubt, notwithstanding anything in this Binding Term Sheet to the contrary, if any IVD Kit Product is developed under any IVD Agreement during the applicable IVD Agreement Term, the right of Roche to manufacture, distribute and sell such IVD Kit Product shall continue for as long as such IVD Kit Product is commercialized by or on behalf of Roche or any of its affiliates, subject to applicable ongoing terms established in such IVD Agreement, including the payment of any royalties, milestones and similar payments.
Termination provisions of the Definitive Agreement, including consequences of termination, will be set forth in the Definitive Agreement. |
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Overview | By entering into the IVD Collaboration, Roche and FMI intend for this Binding Term Sheet and the Definitive Agreement to establish a framework for potential future collaboration(s) to manufacture, distribute and commercialize IVD versions of FMIs products, services and tests ( IVD Kit Products ). FMIs products shall mean (i) FMIs existing products and services (including, but not limited to, FoundationOne ® and FoundationOne ® Heme) and any and all successor products and services, (ii) any and all products and services developed under the Collaboration Agreement and (iii) any and all other future products or services developed by FMI. |
The Parties will work non-exclusively with each other in the development of IVD Kit Products, provided, however, FMI shall work exclusively with Roche with regard to Roche IVD Kit Products (as defined below). For clarity, subject to the terms and conditions of this Binding Term Sheet (including the terms and conditions set forth in the section entitled Roche MFN), both Parties are free to explore and execute kit development and commercialization internally or with third parties on other platforms, provided, however, FMI shall not develop internally or with a third party IVD Kit Products for or using any Roche Platform (as defined below) without the prior written consent of Roche.
In furtherance of the foregoing, the rights granted by FMI to Roche under the this Binding Term Sheet, the Definitive Agreement and each IVD Agreement shall be (A) exclusive with respect to (1) Roche IVD Kit Products, (2) Roche Platforms and (3) any IVD Kit Products within any Roche Exclusive Field (collectively, Roche Exclusive Products ) and (B) otherwise non-exclusive. For the avoidance of doubt, FMI and its affiliates shall work exclusively with Roche in the development and commercialization of Roche Exclusive Products, and neither FMI nor any of its affiliates shall compete with Roche or any of its affiliates with respect to any Roche Exclusive Field. FMI shall not, and shall cause its affiliates not to, grant any third party any rights with respect to any IVD Kit Product that conflict with or otherwise limit any of the rights granted (or contemplated to be granted) to Roche and its affiliates under this Binding Term Sheet, the Definitive Agreement or any IVD Agreement.
For the purposes of this Binding Term Sheet, the Definitive Agreement and each IVD Agreement, (x) Roche IVD Kit Product means any IVD Kit Product that utilizes a Roche Platform, (y) Roche Platform means any sequencing platform owned or controlled by Roche or any of its affiliates, and (z) Roche Exclusive Field means any designated IVD Kit Product field (including disease indication) as the Parties may mutually agree.
Subject to the terms and conditions of this Binding Term Sheet (including the terms and conditions set forth in the section entitled Roche MFN and, with respect to FMI, the terms and conditions set forth in the section entitled Efforts to Negotiate and Enter into Agreement with respect to the occurrence of a Trigger Event), [ *** ]. |
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Development of IVD Kit Products, Selection of Sequencing Platform |
This Binding Term Sheet and the Definitive Agreement - as a framework agreement - will enable one or more IVD Agreements governing IVD Kit Product development and commercialization to be agreed between the Parties and will govern matters on an IVD Kit Product-by-IVD Kit Product basis.
Any IVD Agreement will contain provisions that:
The Parties, through the IVD Development Working Group, will discuss and align on overall strategy, development, and marketing plans for Roche Exclusive Products;
Roche will develop Roche Exclusive Products and be the legal manufacturer of such Roche Exclusive Products;
Specify [ *** ] under any such IVD Agreement.
Roche [ *** ] of development for Roche Exclusive Products;
Roche will be granted exclusive, sublicensable and assignable rights (including intellectual property rights) to manufacture, use, distribute, sell, offer for sale, import and otherwise commercialize Roche Exclusive Products in the United States and/or outside of the United States;
FMI will provide analytical, interpretation, and reporting services for samples processed using Roche Exclusive Products or alternatively will enable Roche to use, directly and on a non-sublicensable basis, FMIs database for analysis, interpretation, and reporting purposes, and Roche [ *** ] related to such Roche Exclusive Products, if any;
FMI will be entitled [ *** ] of Roche Exclusive Products;
FMI will be entitled [ *** ] related to Roche Exclusive Products, [ *** ] of the development of such Roche Exclusive Products;
[ *** ], and
Governance provisions will be as set forth above.
Each IVD Agreement shall define additional terms, including a work plan and budget. |
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Additional FMI Responsibilities |
Research and Platform Development :
FMI will provide genomic analysis, interpretation expertise, and application support in connection with the development of the Roche Platform for use in clinical cancer profiling, on terms to be mutually agreed by the Parties (such activities are hereinafter FMI Development Obligations). |
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Financial Terms |
Roche Platform Development :
Roche shall control the development of the Roche Platform, [ *** ] of any FMI Development Obligations. |
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Roche MFN |
FMI acknowledges and agrees that the rights granted and contemplated to be granted to Roche and its affiliates with respect to IVD Kit Products under this Binding Term Sheet, the Definitive Agreement and each IVD Agreement are and shall be, when considered as part of an integrated whole, no less favorable to Roche and its affiliates than any terms and conditions granted by FMI or any of its affiliates to any third party with respect to the development, commercialization or other exploitation of any IVD Kit Product.
If, at any time after the Effective Date, FMI or any of its affiliates enters into any agreement ( Third Party Agreement ) with any third party pursuant to which FMI or any of its affiliates grants such third party any right to develop, commercialize or otherwise exploit any IVD Kit Product and such agreement includes any terms or conditions that are more favorable, when taken as a whole, than those provided to Roche and its affiliates under this Binding Term Sheet, the Definitive Agreement or any IVD Agreement ( More Favorable Provisions ), then FMI shall promptly provide written notice thereof to Roche, and Roche may elect, at its discretion, to receive the benefit of such More Favorable Provisions under the Definitive Agreement and each IVD Agreement, whether then in effect or entered into thereafter (it being understood that, if no Definitive Agreement has been entered into between the Parties at the time such More Favorable Provisions have been provided to any such third party, a Trigger Event shall be deemed to have occurred). Upon any such election by Roche, the Definitive Agreement and each IVD Agreement, as applicable, shall automatically be deemed to have been amended and modified such that, from the date on which any such More Favorable Provisions are first so provided to a third party and thereafter, Roche and its affiliates shall be provided such More |
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Favorable Provisions (it being understood that, if Roche elects to accept such More Favorable Provisions with respect to any Definitive Agreement or IVD Agreement in which the Relevant Terms thereof are materially different than the Relevant Terms of the Third Party Agreement, the Parties shall, in good faith, use commercially reasonable efforts to modify such More Favorable Provisions in a manner that accounts for such difference).
For the purposes of this Binding Term Sheet, the Definitive Agreement and each IVD Agreement, Relevant Terms means, with respect to any agreement for the development, commercialization or other exploitation of IVD Kit Products, the (i) scope of work to be pursued thereunder, including the type and number of IVD Kit Products to be developed, (ii) geographic scope of such development, commercialization or other exploitation, (iii) [ *** ] and (iv) [ *** ].
Notwithstanding anything in this Binding Term Sheet, the Definitive Agreement or any IVD Agreement to the contrary, neither FMI nor any of its affiliates shall take any action designed or intended to evade, frustrate or otherwise circumvent the intent or purpose of this section. |
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Miscellaneous | This Binding Term Sheet shall be governed by the laws of the State of New York, without regard to the conflicts of law rules of such state. The Parties acknowledge and agree that the United Nations Convention on Contracts for the International Sale of Goods (the Vienna Convention) shall not apply to this Binding Term Sheet. The provisions of Sections 19.2 and 19.3 of the Collaboration Agreement are incorporated herein and shall apply mutatis mutandis. Neither Party shall have the right to assign or otherwise transfer this Binding Term Sheet or any part thereof to any third party without the prior written approval of the other Party, provided that either Party may assign this Binding Term Sheet to any of its affiliates without the approval of the other Party. If any of the provisions of this Binding Term Sheet are held to be void or unenforceable, then such void or unenforceable provisions shall be replaced by valid and enforceable provisions that will achieve as far as possible the economic business intentions of the Parties; provided, however, that the remainder of this Binding Term Sheet will remain in full force and effect to the extent that the material interests of the |
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Parties are not affected. Any provision of this Binding Term Sheet may be amended or waived if, but only if, such amendment or waiver is in writing and is signed, in the case of an amendment, by each Party, or in the case of a waiver, by the Party against whom the waiver is to be effective. The failure by either Party to require strict performance and/or observance of any obligation, term, provision or condition under this Binding Term Sheet will neither constitute a waiver thereof nor affect in any way the right of the respective Party to require such performance and/or observance. This Binding Term Sheet, the Collaboration Agreement and the Existing CDA contain the entire understanding between the Parties with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, both oral and written, between the Parties with respect to the subject matter hereof and thereof. This Binding Term Sheet may be signed in any number of counterparts, each of which shall be an original, with the same effect as if the signatures thereto and hereto were upon the same instrument. |
[Signature Page Follows]
IN WITNESS WHEREOF, the Parties have entered into this Binding Term Sheet as of the Effective Date.
Foundation Medicine, Inc. | ||
/s/ Steven J. Kafka |
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Name: | Steven J. Kafka | |
Title: | Chief Operating Officer |
F. Hoffmann-La Roche Ltd | ||||||||
/s/ Christian Hebich |
/s/ Roland Diggelmann |
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Name: | Christian Hebich | Name: | Roland Diggelmann | |||||
Title: | Head of Finance/Services Roche Diagnostics | Title: | COO Roche Diagnostics |