CO-DEVELOPMENT AND COLLABORATION AGREEMENT By and Between AVEO PHARMACEUTICALS, INC. and BIODESIX, INC.
Exhibit 10.2 | ||
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions. |
EXECUTION VERSION
CO-DEVELOPMENT AND COLLABORATION AGREEMENT
By and Between
AVEO PHARMACEUTICALS, INC.
and
BIODESIX, INC.
EXECUTION VERSION
Table of Contents
Page | ||||||
ARTICLE I - DEFINITIONS |
1 | |||||
ARTICLE II - GOVERNANCE |
11 | |||||
2.1. |
Creation and Structure of the JSC |
11 | ||||
2.2. |
Meetings |
12 | ||||
2.3. |
Responsibilities of the JSC |
12 | ||||
2.4. |
Subcommittees of the JSC and Other Committees |
13 | ||||
2.5. |
Decisions of the JSC |
13 | ||||
2.6. |
Limitation on JSC Authority |
13 | ||||
2.7. |
Alliance Managers |
13 | ||||
2.8. |
Reports to JSC |
13 | ||||
2.9. |
Joint Co-Development Team |
13 | ||||
2.10. |
Dissolution |
14 | ||||
ARTICLE III - FICLATUZUMAB DEVELOPMENT; COST RESPONSIBILITIES; DEVELOPMENT OPT-OUT |
14 | |||||
3.1. |
Ficlatuzumab Development |
14 | ||||
3.2. |
Modifications to Development Plan |
14 | ||||
3.3. |
Existing Supply of Ficlatuzumab |
15 | ||||
3.4. |
Clinical Specimens |
15 | ||||
3.5. |
Funding; Opt-Out |
16 | ||||
3.6. |
Opt-Out Mechanics |
17 | ||||
3.7. |
AVEO Covenants |
19 | ||||
ARTICLE IV - LICENSING AND LICENSE REVENUE SHARING |
20 | |||||
4.1. |
General |
20 | ||||
4.2. |
Scope |
20 | ||||
4.3. |
License Income |
21 | ||||
ARTICLE V - PAYMENTS |
21 | |||||
5.1. |
Development Costs |
21 | ||||
5.2. |
License Income |
21 | ||||
5.3. |
Payment Terms |
21 | ||||
5.4. |
Late Payments |
22 | ||||
5.5. |
Books and Records; Audit Rights |
22 | ||||
5.6. |
Taxes |
22 |
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EXECUTION VERSION
ARTICLE VI - NEGOTIATION OF DEFINITIVE FICLATUZUMAB CO-COMMERCIALIZATION AGREEMENT |
23 | |||||
6.1. |
Negotiation of Definitive Commercialization Agreement |
23 | ||||
6.2. |
Definitive Term |
23 | ||||
ARTICLE VII - VERISTRAT DEVELOPMENT AND COMMERCIALIZATION |
23 | |||||
7.1. |
VeriStrat Development |
23 | ||||
7.2. |
Modifications to VeriStrat Development Plan |
24 | ||||
7.3. |
Regulatory |
24 | ||||
7.4. |
Use of XxxxXxxxx |
00 | ||||
ARTICLE VIII - LICENSE GRANTS; RIGHT OF FIRST NEGOTIATION |
25 | |||||
8.1. |
Grants of Rights – Intellectual Property |
25 | ||||
8.2. |
Grant of Rights – Data |
26 | ||||
8.3. |
Rights Retained by the Parties |
26 | ||||
8.4. |
Section 365(n) of the Bankruptcy Code |
27 | ||||
8.5. |
Option and Right of First Refusal |
27 | ||||
ARTICLE IX - INTELLECTUAL PROPERTY |
27 | |||||
9.1. |
Ownership of Inventions |
27 | ||||
9.2. |
Ownership of Data; Ownership and License to Clinical Specimens |
28 | ||||
9.3. |
Prosecution and Maintenance of Patent Rights |
29 | ||||
9.4. |
Third Party Infringement |
29 | ||||
9.5. |
Patent Invalidity Claim |
30 | ||||
9.6. |
Trademarks |
30 | ||||
ARTICLE X - CONFIDENTIAL INFORMATION |
31 | |||||
10.1. |
Treatment of Confidential Information |
31 | ||||
10.2. |
Confidential Information |
31 | ||||
10.3. |
Publication Rights |
32 | ||||
10.4. |
Required Disclosure |
32 | ||||
10.5. |
Disclosure of Agreement |
32 | ||||
ARTICLE XI - REPRESENTATIONS, WARRANTIES AND COVENANTS |
33 | |||||
11.1. |
AVEO’s Representations |
33 | ||||
11.2. |
Biodesix’s Representations |
35 | ||||
11.3. |
Compliance |
36 | ||||
11.4. |
No Warranty |
36 | ||||
ARTICLE XII - INDEMNIFICATION AND INSURANCE |
37 | |||||
12.1. |
Indemnification in Favor of AVEO |
37 |
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EXECUTION VERSION
12.2. |
Indemnification in Favor of Biodesix |
37 | ||||
12.3. |
General Indemnification Procedures |
38 | ||||
12.4. |
Insurance |
39 | ||||
ARTICLE XIII - TERM AND TERMINATION | 39 | |||||
13.1. |
Term |
39 | ||||
13.2. |
Termination for Cause |
40 | ||||
13.3. |
Termination for Insolvency |
40 | ||||
13.4. |
Effect of Termination and Expiration; Accrued Rights and Obligations |
40 | ||||
13.5. |
Survival |
41 | ||||
ARTICLE XIV - DISPUTE RESOLUTION |
41 | |||||
14.1. |
Informal Resolution |
41 | ||||
14.2. |
Arbitration |
41 | ||||
14.3. |
No Limitation |
42 | ||||
ARTICLE XV - MISCELLANEOUS |
42 | |||||
15.1. |
Governing Law |
42 | ||||
15.2. |
Waiver |
42 | ||||
15.3. |
Notices |
42 | ||||
15.4. |
Entire Agreement |
44 | ||||
15.5. |
Headings |
44 | ||||
15.6. |
Severability |
44 | ||||
15.7. |
Registration and Filing of the Agreement |
44 | ||||
15.8. |
Assignment; Change of Control |
44 | ||||
15.9. |
Counterparts |
45 | ||||
15.10. |
Force Majeure |
45 | ||||
15.11. |
Public Disclosure |
46 | ||||
15.12. |
Third-Party Beneficiaries |
46 | ||||
15.13. |
Relationship of the Parties |
46 | ||||
15.14. |
Performance by Affiliates |
47 | ||||
15.15. |
Construction |
47 | ||||
15.16. |
No Consequential or Punitive Damages |
47 |
iii
EXECUTION VERSION
The Exhibits referred to in this Agreement have been attached to this Agreement and shall have the following titles:
Exhibit A | Initial Development Plan | |
Exhibit B | Summary of Terms of Commercialization Agreement | |
Exhibit C | Press Release | |
Exhibit D | AVEO Third Party Agreements | |
Exhibit E | Initial VeriStrat Development Plan |
The following Schedules referred to in this Agreement have been attached to this Agreement:
Schedule 8.1(c)
Schedule 11.1(k)
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EXECUTION VERSION
CO-DEVELOPMENT AND COLLABORATION AGREEMENT
This CO-DEVELOPMENT AND COLLABORATION AGREEMENT (this “Agreement”), dated as of April 9, 2014 (the “Effective Date”), is entered into by and between AVEO PHARMACEUTICALS, INC. (“AVEO”), a Delaware corporation having a principal office at 000 X. Xxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000, and Biodesix, Inc. (“Biodesix”), a Delaware corporation having a principal office located at 0000 Xxxxxxxxxx Xxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxx 00000. AVEO and Biodesix are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
When used in this Agreement, each of the following terms shall have the meanings set forth in this Article I.
1.1. “Affiliate”. Affiliate means with respect to a Party, any Person that directly or indirectly controls, is controlled by, or is under common control with such Party. As used in this definition, the term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through ownership of
EXECUTION VERSION
voting securities, by contract or otherwise. For purposes of this definition, “control” shall be presumed to exist if one of the following conditions are met: (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors, and (b) in the case of non-corporate entities, direct or indirect ownership of more than fifty percent (50%) of the equity interests with the power to direct the management and policies of such non-corporate entities.
1.2. “Antibody”. Antibody means any immunoglobulin molecule (such as an IgG), whether in monospecific or any other form, and shall include any immunoglobulin fragment (such as an Fv, Fab or F(ab’)2), any fusion protein comprising an immunoglobulin or immunoglobulin fragment and any single chain antibody (such as an scFv), and any truncation or derivative of any of the foregoing.
1.3. “AVEO Intellectual Property”. AVEO Intellectual Property means the AVEO Know-How and the AVEO Patent Rights.
1.4. “AVEO Know-How”. AVEO Know-How means: (a) any Know-How Controlled by AVEO or (subject to Section 15.8) its Affiliates as of the Effective Date or during the Term relating to Ficlatuzumab, including such Know-How that relates to AVEO Sole Inventions or the Development, Manufacture, use or Commercialization of Ficlatuzumab and such Know-How relating to Ficlatuzumab that was generated or developed collectively or by either Party pursuant to the MTA; and (b) AVEO’s interest in any Joint Inventions.
1.5. “AVEO Patent Rights”. AVEO Patent Rights means: (a) all Patent Rights Controlled by AVEO or (subject to Section 15.8) its Affiliates as of the Effective Date or thereafter during the Term that claim or disclose AVEO Know-How; and (b) AVEO’s interest in the Joint Patent Rights.
1.6. “AVEO Third Party Agreements”. AVEO Third Party Agreements means the agreements set forth on Exhibit D.
1.7. “Biodesix Intellectual Property”. Biodesix Intellectual Property means the Biodesix Know-How and the Biodesix Patent Rights.
1.8. “Biodesix Know-How”. Biodesix Know-How means: (a) any Know-How Controlled by Biodesix or (subject to Section 15.8) its Affiliates as of the Effective Date or during the Term relating to VeriStrat, including such Know-How that relates to Biodesix Sole Inventions or the Development, Manufacture, use or Commercialization of VeriStrat and such Know-How relating to VeriStrat that was generated or developed collectively or by either Party pursuant to the MTA; and (b) Biodesix’s interest in any Joint Inventions.
1.9. “Biodesix Patent Rights”. Biodesix Patent Rights means: (a) all Patent Rights that are Controlled by Biodesix or (subject to Section 15.8) its Affiliates as of the Effective Date or thereafter during the Term that claim or disclose Biodesix Know-How; and (b) Biodesix’s interest in the Joint Patent Rights.
1.10. “Biomarker Data”. Biomarker Data, which excludes Diagnostic Data, means genetic, genomic and proteomic characteristics and annotations, including all available genetic
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data such as EGFR mutation status or KRAS mutation status, that may or could form the basis of an IVD, which characteristics and annotations are generated in human clinical and/or preclinical trials of Ficlatuzumab in connection with this Agreement or which were generated by either Party pursuant to the MTA.
1.11. “Business Day”. Business Day means a day that is not a Saturday, Sunday or a day on which banking institutions in Cambridge, Massachusetts or in Boulder, Colorado are authorized by Law to remain closed.
1.12. “Calendar Quarter”. Calendar Quarter means each of the periods ending on March 31, June 30, September 30, and December 31 of any year.
1.13. “Calendar Year”. Calendar Year means each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided that the first Calendar Year of the Term shall begin on the Effective Date and end on December 31, 2014 and the last Calendar Year of the Term shall end on the last day of the Term.
1.14. “Change of Control”. Change of Control means, in respect of a Party hereto, the occurrence of a tender offer, stock purchase, other stock acquisition, merger, consolidation, recapitalization, reverse split, sale or transfer of assets or other transaction, as a result of which any person, entity or group (a) becomes the beneficial owner, directly or indirectly, of securities of such Party representing more than 50% of the ordinary shares of such Party or representing more than 50% of the combined voting power with respect to the election of directors (or members of any other governing body) of such Party’s then outstanding securities, or (b) obtains the ability to appoint a majority of the Board of Directors (or other governing body) of such Party, or obtains the ability to direct the operations or management of such Party or any successor to such Party’s business; provided, however, that Change in Control shall not include the issuance by a Party of equity to the public through a public offering or offerings.
1.15. “Clinical Data”. Clinical Data means all relevant clinical, biological, and other characteristics and annotations, excluding Biomarker Data and Diagnostic Data, provided by AVEO or generated in human clinical trials of Ficlatuzumab in connection with this Agreement or the MTA, including age, gender, race, smoking history, current therapies, previous therapies, disease state at sample collection date, performance status at sample collection date, sample collection date, sample collection site, date of start of treatment, drug exposure, adverse events, lab abnormalities, disposition, concomitant medications and all available outcome data (progression free survival, overall survival, time to progression, objective response data (including date of collection), and the date of tissue collection. The Clinical Data supplied to Biodesix by AVEO shall not contain any personal patient identifying information, such as patients’ names, initials, and dates of birth (such de-identified Clinical Data, the “Limited Data Set”).
1.16. “Clinical Specimens.” Clinical Specimens mean all clinical specimens, samples, tissues, fluid, and other biological and pharmaceutical materials generated or obtained in connection with this Agreement or the MTA, and modifications thereof.
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EXECUTION VERSION
1.17. “Commercialization” and “Commercialize”. Commercialization or Commercialize means pre-launch, launch or post-launch activities directed to obtaining pricing and reimbursement approvals, marketing, branding, promoting, distributing, importing or selling a product. Commercialization includes strategic marketing, market research, sales force recruitment, training and meetings, sales force detailing, sample drops, activities related to managed care accounts and other similar accounts and government programs, activities related to reimbursement, advertising, market and product support, customer support, educational initiatives, product distribution, invoicing, sales activities and post-marketing studies.
1.18. “Commercialization Agreement”. Commercialization Agreement means the separate written agreement that the Parties will negotiate in good faith and enter into pursuant to Article VI, which agreement will include the terms set forth in Exhibit B hereto, as the same may be supplemented to add mutually acceptable detail.
1.19. “Commercially Reasonable Efforts”. Commercially Reasonable Efforts means that degree of skill, effort, expertise, and resources normally used by an established biotechnology company or diagnostic company (as applicable) with respect to products that have a similar market potential to, and that are at a similar stage in product life as, Ficlatuzumab or VeriStrat (as applicable), taking into account issues of safety and efficacy, costs and risks of Development, Manufacture and Commercialization, the competitiveness of the marketplace, the proprietary position of the applicable product, the likelihood of obtaining Regulatory Approval for the applicable product, the potential economic return from the applicable product and other relevant technical, legal, scientific, medical or commercial factors.
1.20. “Companion Diagnostic.” Companion Diagnostic means an IVD that provides information regarding the identification of patients for treatment with a corresponding therapeutic product, including where such use may be specified in the instructions for use in the labeling of both the IVD device and the corresponding therapeutic product in relevant jurisdictions.
1.21. “Control” or “Controlled”. Control or Controlled means, with respect to any Patent Rights or Know-How, possession (whether by ownership or license, other than pursuant to this Agreement) by a Party or its Affiliates of the ability to grant the licenses or sublicenses as provided for herein without violating the terms of any agreement or other arrangement with any Third Party.
1.22. “CPI”. CPI means the Consumer Price Index – Urban Wage Earners and Clerical Workers, U.S. City Average, All Items, 1982-84 = 100, published by the United States Department of Labor, Bureau of Labor Statistics (or its successor equivalent index) in the United States.
1.23. “Development”. Development, as it pertains to Ficlatuzumab, means non-clinical (including pre-clinical) and clinical drug development activities and related research, including, among other things: (i) pharmacology studies, (ii) absorption, distribution, metabolism, elimination (ADME ) studies, (iii) toxicology studies, (iv) statistical analysis and report writing, (v) drug-test method development and stability testing, (vi) process development, (vii) formulation development, (viii) delivery system development, (ix) translational research, (x)
4
quality assurance and quality control development, (xi) compliance related monitoring and activities (including biometry, data management, drug safety, integrated analysis, and health and economic research), (xii) clinical trials for the purpose of obtaining or maintaining Regulatory Approval, (xiii) Investigator Sponsored Clinical Studies, (xiv) safety related studies and risk management programs, (xv) preparation of applications for regulatory approval, (xvi) clinical supply operations, including packaging and labeling a drug for investigational supply and shipping drug to clinical trial sites, and (xvii) regulatory affairs related to all of the foregoing. Development, as it pertains to VeriStrat in connection with Ficlatuzumab, means non-clinical (including pre-clinical) and clinical assay development, related research, analytical development and validation and regulatory submission activities, including development and submission of a PMA or CE-IVD submission to be filed with the relevant Regulatory Authority. When used as a verb, “Develop” means to engage in Development.
1.24. “Development Costs”. Development Costs means the internal and external costs of a Party and/or its Affiliates incurred in Developing Ficlatuzumab, which costs shall include all costs and expenses invoiced by Third Parties for goods or services (including direct costs of labor, materials, supplies, services, fees and other resources directly consumed or used in the Development of Ficlatuzumab), Third Party license fees (including those associated with in-licenses), and the FTE Costs (calculated in accordance with GAAP, consistently applied) of a Party’s, and/or its Affiliates’, employees with respect to time properly allocated to the Development of Ficlatuzumab. For the avoidance of doubt, except for those FTE costs associated with research intended to understand the VeriStrat mechanism, which FTE costs shall be excluded from Development Costs and Additional Development Costs hereunder, all internal and external costs incurred by AVEO that are directly related to the Development Plan activities and all Additional Development Costs constitute Development Costs hereunder.
1.25. “Diagnostic Data.” Diagnostic Data means any data or information provided by Biodesix or generated in the Development or performance of VeriStrat obtained from any of (i) the generation of raw mass spectra from the Clinical Specimens, (ii) processing the raw mass spectra to generate the VeriStrat Labels from the Clinical Specimens, (iii) the reporting of VeriStrat Labels to AVEO in a suitable format; (iv) the preparation of any reports assessing the performance of VeriStrat with the Clinical Specimens and Clinical Data (the “VeriStrat Results”) or (v) the reporting of the VeriStrat Results to AVEO.
1.26. “EMEA”. EMEA means the European Medicines Evaluation Agency, or any successor agency with responsibility for regulating the Development, Manufacture and Commercialization of human or veterinary pharmaceutical, diagnostic, or prophylactic products.
1.27. “Existing Supply of Ficlatuzumab” means the supply of Ficlatuzumab that was manufactured prior to the Effective and which AVEO has on-hand as of the Effective Date, which totals approximately [**] kilograms of Ficlatuzumab drug product filled in vials and [**] kilograms of Ficlatuzumab drug substance.
1.28. “FDA” or “Food and Drug Administration”. FDA or Food and Drug Administration means the United States Food and Drug Administration and any successor agency thereto with responsibility for regulating the Development, Manufacture and Commercialization of human or veterinary pharmaceutical, diagnostic, or prophylactic products.
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EXECUTION VERSION
1.29. “Ficlatuzumab”. Ficlatuzumab means the humanized monoclonal Antibody that binds hepatocyte growth factor and is designated by AVEO as “Ficlatuzumab.”
1.30. “Ficlatuzumab Cost of Goods”. Ficlatuzumab Cost of Goods means the standard unit cost of Manufacture of Ficlatuzumab, consisting of direct material and direct labor costs plus Manufacturing overhead attributable to Ficlatuzumab (including all directly incurred manufacturing variances), all calculated in accordance with GAAP, consistently applied. Direct material costs will include the costs incurred in Manufacturing or purchasing materials, including freight-in costs, sales and excise taxes imposed thereon and customs duty and charges levied by government authorities, and all costs of packaging components. Direct labor costs will include the FTE Costs of employees engaged in direct Manufacturing activities and direct or indirect quality control and quality assurance activities who are directly employed in Manufacturing and packaging Ficlatuzumab. Overhead attributable to Ficlatuzumab will be calculated and allocated in a manner consistent with the method used to allocate overhead to other products Manufactured in the same facility. Overhead attributable to Ficlatuzumab will include a reasonable allocation of indirect labor (not previously included in direct labor costs), a reasonable allocation of administrative costs, and a reasonable allocation of facilities costs, all in accordance with GAAP, consistently applied. Overhead will not include corporate administrative overhead or plant start-up costs or costs associated with excess or idle capacity. Alternatively, if Ficlatuzumab is Manufactured by a Third Party manufacturer, the Ficlatuzumab Cost of Goods means the actual price paid by a Party and/or its Affiliates to the Third Party for the Manufacture, supply and packaging of Ficlatuzumab and all taxes and shipping costs related thereto, and the FTE Costs of such Party’s and/or its Affiliates’ employees engaged in activities relating to the selection and management of such Third Party manufacturer and the management of such supply (including quality control and quality assistance activities).
1.31. “First Commercial Sale”. First Commercial Sale means the first bona fide arm’s length sale of Ficlatuzumab sold to a Third Party in the Territory by or on behalf of a Party, its Affiliates or Licensees after Regulatory Approval has been obtained for Ficlatuzumab.
1.32. “FTE”. FTE means the number of full-time-equivalent person-years (each consisting of a total of [**] hours) of Development, Manufacturing or Commercialization work by each Party’s personnel on or directly related to the applicable activity conducted hereunder.
1.33. “FTE Cost”. FTE Cost means the amount obtained by multiplying (a) the number of FTEs by (b) $[**], increased annually by the percentage increase in the CPI as of December 31 of the then most recently ended Calendar Year (if any) over the level of the CPI as of December 31 of the preceding Calendar Year, (i.e., the first such increase could occur on January 1, 2015 and would be based on the CPI percentage increase between December 31, 2013 and December 31, 2014).
1.34. “GAAP”. GAAP means accounting principles generally accepted in the United States of America, as consistently applied.
1.35. “Intellectual Property”. Intellectual Property means Know-How and the Patent Rights.
1.36. “IND” or “Investigational New Drug Application”. IND or Investigational New Drug Application means (a) (i) in the United States, an Investigational New Drug Application, as defined in the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time (the “FD&C Act”), and the regulations promulgated thereunder, as amended from time to time, that is required to be filed with the FDA before beginning clinical testing of a product in human subjects, or any successor application or procedure, and (ii) any counterpart of such Investigational New Drug Application in any country other than the United States in the Territory (e.g., a CTX), and (b) all supplements and amendments that may be filed with respect to any of the foregoing.
1.37. “Investigator Sponsored Clinical Study”. Investigator Sponsored Clinical Study means a human clinical study of a product that is sponsored and conducted by a Third Party under an agreement with a Party pursuant to which such Party provides the Third Party with clinical supplies of the product or funding for such clinical study.
1.38. “Joint Patent Rights”. Joint Patent Rights means all Patent Rights that claim or disclose Joint Inventions.
1.39. “Know-How”. Know-How means proprietary, non-public information and materials, whether patentable or not, including (a) ideas, discoveries, inventions, improvements or trade secrets, (b) pharmaceutical, chemical and biological materials, products and compositions, (c) tests, assays, techniques, data, methods, procedures, formulas, and/or processes, (d) technical and non-technical data and other information relating to any of the foregoing, (e) drawings, plans, designs, diagrams, sketches, specifications and/or other documents containing or relating to such information or materials, and (f) business processes, price data and information, marketing data and information, sales data and information, marketing plans and market research.
1.40. “Law” or “Laws”. Law or Laws means all statutes, laws, rules, regulations, administrative codes, ordinances, decrees, orders, decisions, injunctions, awards judgments, permits and licenses of or from governmental authorities, including those promulgated by a Regulatory Authority and the listing standards or agreements of any national or international securities exchange.
1.41. “License Income”. License Income shall mean all amounts received by a Party and/or its Affiliates from Third Parties in connection with or related to the licensing or sublicensing to such Third Parties of rights to Ficlatuzumab, including: (i) all upfront fees, milestone payments and royalties; (ii) transfer pricing amounts paid in respect of Ficlatuzumab supplied to such Third Parties; (iii) investments in securities; and (iv) research and Development funding, but (notwithstanding the foregoing) excluding:
(a) transfer pricing amounts equal to such Party’s and/or its Affiliates’ Ficlatuzumab Cost of Goods supplied to such Third Parties;
(b) amounts received by such Party and/or its Affiliates from such Third Parties as the purchase price for such Party’s and/or its Affiliates’ debt or equity securities at prices not in excess of the then-current market price of such securities or, if such securities are not publicly traded, the then-current fair market value of such securities;
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EXECUTION VERSION
(c) amounts received by such Party and/or its Affiliates for future research and Development activities undertaken for, or in collaboration with, or other services provided to, such Third Parties at rates not to exceed the fair market value of such services, and
(d) amounts received by such Party and/or its Affiliates as reimbursement for costs incurred by such Party and/or its Affiliates after the grant of the license or sublicense in the performance of such Party’s and/or its Affiliates’ obligations thereunder.
1.42. “Licensee”. Licensee means a Third Party that is not an Affiliate of a Party and to whom a Party has granted a license or sublicense to Develop, Commercialize, Manufacture, fill and finish, register, distribute and/or sell Ficlatuzumab.
1.43. “Major Markets”. Major Markets means the United States, Japan and each individual member state of the European Union (as they may exist from time to time during the Term).
1.44. “Manufacture”. Manufacture means, with respect to a product, all activities related to the manufacturing of such product, including test method development and stability testing, formulation, process development, manufacturing scale-up, manufacturing for use in non-clinical and clinical studies, manufacturing for commercial sale, packaging, release of product, quality assurance/quality control development, quality control testing (including in-process release and stability testing) and release of product or any component or ingredient thereof, and regulatory activities related to all of the foregoing.
1.45. “MHW”. MHW means the Japanese Ministry of Health, Labour and Welfare, or any successor agency with responsibility for regulating the Development, Manufacture and Commercialization of human or veterinary pharmaceutical, diagnostic, or prophylactic products.
1.46. “NSCLC”. NSCLC means non-small-cell lung carcinoma.
1.47. “NSCLC POC Trial”. NSCLC POC Trial means a [**] of Ficlatuzumab in which VeriStrat will be used to select clinical trial subjects that is designed to demonstrate efficacy in treating NSCLC in accordance with the NSCLC POC Trial Plan and that, if applicable study endpoints are achieved, would: (a) [**] of Ficlatuzumab; and (b) support the strategy of seeking Regulatory Approval for Ficlatuzumab, however, in the event that, upon a decision by the JSC, the Parties [**] and for the purposes of the Opt-Out, the completion of the [**] shall be the decision point for such Opt-Out, including for the purposes of Section 3.5(c)(ii).
1.48. “NSCLC POC Trial Plan”. NSCLC POC Trial Plan means the written plan outlining the activities to be conducted by or on behalf of the Parties in furtherance of a NSCLC POC Trial, as is set forth as part of the Development Plan attached hereto as Exhibit A and as may be amended from time to time pursuant to Section 3.2.
1.49. “Opt-Out”. Opt-Out means an election by one Party to cease further participation in funding and conducting the NSCLC POC Trial or in funding Additional Development Costs.
1.50. “Opt-Out Phase”. Opt-Out Phase means the phase of this Agreement following the effective date of Opt-Out as described in Section 3.5(c), if any.
1.51. “Opt-Out Royalty”. Opt-Out Royalty means the royalty described in Exhibit B, as the same shall be set forth in the Commercialization Agreement.
1.52. “Party” or “Parties”. Party or Parties means AVEO and/or Biodesix, as the context requires.
1.53. “Patent Rights”. Patent Rights means the rights and interest in and to all issued patents and pending patent applications in any country or jurisdiction in the Territory, including, all provisionals, divisions, continuations, renewals, continuations-in-part, patents of addition, re-examinations, supplementary protection certificates, extensions, registrations or confirmation patents, restoration of patent terms, and reissues thereof.
1.54. “Person”. Person means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization.
1.55. “Phase 2 Clinical Trial”. Phase 2 Clinical Trial means a human clinical trial in the United States that would satisfy the requirements of 21 CFR 312.21(b) or an equivalent human clinical trial in any country outside the United States that would satisfy the requirements applicable to such human clinical trial in such country.
1.56. “Phase 3 Clinical Trial”. Phase 3 Clinical Trial means a human clinical trial in the United States that would satisfy the requirements of 21 CFR 312.21(c) or an equivalent human clinical trial in any country outside the United States that would satisfy the requirements applicable to such human clinical trial in such country.
1.57. “Profit Sharing Phase”. Profit Sharing Phase means the phase of this Agreement prior to the effective date of any Opt-Out.
1.58. “Regulatory Approval”. Regulatory Approval means the granting, whether through lapse of time or otherwise, by a Regulatory Authority of approval to market a pharmaceutical product or in vitro diagnostic product in a country in the Territory including, for example, an New Drug Application, (“NDA”), Biologics License Application (“BLA”), and Premarket Approval (“PMA”), among others.
1.59. “Regulatory Authority”. Regulatory Authority means any United States federal, state, or local government, or any foreign government, or political subdivision thereof, or any multinational organization or authority or any authority, agency or commission entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, any court or tribunal (or any department, bureau or division thereof), or any governmental arbitrator or arbitral body, including the FDA, EMEA or MHW, with responsibility for granting licenses or approvals (with the exception of price approvals) necessary for the marketing and sale of pharmaceutical products or IVD devices in any country.
1.60. “Territory”. Territory means all countries of the world.
1.61. “Third Party”. Third Party means any entity other than AVEO or Biodesix or any of their respective Affiliates.
1.62. “United States”. United States means the United States, its territories and possessions.
1.63. “VeriStrat”. VeriStrat means Biodesix’s mass spectrometry and software-based test system, which stratifies patients into groups with different outcomes following treatment with various pharmaceutical agents, and any progeny, improvements and derivatives thereof, as the same may be rebranded in the sole discretion of Biodesix (e.g., “Ficlastrat”).
1.64. “VeriStrat Cost of Goods”. VeriStrat Cost of Goods means the aggregate costs incurred in delivering Biodesix’s VeriStrat test results to clinicians calculated on a per test basis which costs consist of (1) direct labor, (2) logistics, (3) supplies, (4) equipment and infrastructure, (5) license and royalties and (6) other directly related costs, which aggregate costs shall not exceed $[**] per test plus international shipping costs, if any. Direct labor includes the costs of laboratory personnel. Logistics includes the cost of collection kits, sample collection expenses, and shipping charges to transport kits to the clinician sites and samples from the clinician sites to our laboratory, excluding international shipping costs which shall be in addition to any such costs for logistics. Supplies reflects the costs of supplies used to process test samples. Equipment and infrastructure includes depreciation and maintenance costs associated with equipment used to process test samples as well as facility occupancy and allocated overhead costs. Licenses and royalties are calculated per contracted agreements. Other directly related costs include patent amortization, software expenses, collection fees on revenue and contracted services.
1.65. “VeriStrat Labels”. VeriStrat Labels mean the clinical labels generated upon the performance of VeriStrat, where such label(s) indicate differential clinical outcomes associated with each respective patient so analyzed under VeriStrat.
Definition: |
Section: | |
AAA | 14.2(a) | |
Additional Development Costs | 3.5(b) | |
Agents | 10.1 | |
Agreement | Preamble | |
Alliance Manager | 2.7 | |
assignee | 9.1(e) | |
assignor | 9.1(e) | |
audited Party | 5.5 | |
auditing Party | 5.5 | |
AVEO | Preamble | |
AVEO Parties | 12.1 |
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EXECUTION VERSION
Definition: |
Section: | |
Biodesix | Preamble | |
Biodesix Parties | 12.2 | |
Cap | 3.5(a) | |
Confidential Information | 10.2 | |
Commercial Insurance | 12.4 | |
Deposit | 5.1 | |
Development Plan | 3.1 | |
Effective Date | Preamble | |
Indemnified Party | 12.3(a) | |
Indemnifying Party | 12.3(a) | |
IVD | 3.1(c) | |
JCDT | 2.9 | |
JSC | 2.1 | |
Limited Data Set | 1.15 | |
Losses | 12.1 | |
MCA | Introduction | |
MTA | Introduction | |
Opt-Out Notice | 3.5(c) | |
Personal Data | 3.4(a) | |
[**] | [**] | |
Product Liability Insurance | 12.4 | |
Term | 13.1 | |
Third Party Claims | 12.1 | |
VeriStrat Development Plan | 7.1 | |
VeriStrat Results | 1.25 |
neither Party shall charge the other Party, whether through Ficlatuzumab Cost of Goods or otherwise, any FTE or overhead costs for such Party’s [**] designated representatives’ participation in the JSC or such [**] designated representatives’ activities performed hereunder.
(a) reviewing, approving, monitoring and modifying (as the JSC deems appropriate) the Development Plan (including associated budgets) and, subject to execution of the Commercialization Agreement, the Commercialization plan(s) and budget(s) thereunder;
(b) reviewing, approving, monitoring and modifying (as the JSC deems appropriate) the VeriStrat Development Plan;
(c) planning strategy, coordinating and monitoring the progress of the Development of Ficlatuzumab and Veristrat in connection with Ficlatuzumab, including the NSCLC POC Trial; and
(d) approving licensing of Development and/or Commercialization rights to Ficlatuzumab as contemplated by Section 4.1.
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Plan with the VeriStrat Development Plan. The JCDT shall consist of [**] representatives designated by each Party, or such other number as the Parties may mutually agree. Each Party shall designate representatives for participation in the JCDT, [**]. AVEO will lead drafting of the Development Plan, including publication and presentations plans for review by the JCDT, and Biodesix will lead drafting of the VeriStrat Development Plan, including publication and presentation plans for review by the JCDT. The JCDT shall be responsible for agreeing to and integrating the foregoing plans for submission to the JSC for approval for each indication.
ARTICLE III - FICLATUZUMAB DEVELOPMENT; COST RESPONSIBILITIES; DEVELOPMENT OPT-OUT
3.1. Ficlatuzumab Development.
(a) Prior to the Effective Date, AVEO commenced a Development program for Ficlatuzumab, and following the Effective Date AVEO shall use Commercially Reasonable Efforts to continue to Develop Ficlatuzumab pursuant to Development plans approved by the JSC (such plans, collectively the “Development Plan”), as such Development Plan may be amended by the JSC from time to time. An initial Development Plan is attached hereto as Exhibit A and includes the NSCLC POC Trial Plan.
(b) The Parties will use Commercially Reasonable Efforts to complete their respective obligations under the Development Plan within the timeframes specified in the Development Plan. Each Party will promptly inform the other Party in the event that it anticipates or experiences a delay in the completion of any such obligations. Each Party shall be responsible for any delay or failure by it (or its Affiliates) to timely complete its obligations under the Development Plan, except (a) to the extent that such failure or delay is caused by a delay or failure of performance by the other Party or a contract manufacturer, or (b) as may otherwise be mutually agreed in writing by the Parties. Notwithstanding the foregoing, AVEO shall not have any further obligation to continue to conduct the Development Plan during the Opt-Out Phase.
(c) The Parties will collaborate on the regulatory strategy in the jurisdictions in the Territory for obtaining Regulatory Approval for the combination use of Ficlatuzumab in connection with the in vitro diagnostic (“IVD”) developed pursuant to the VeriStrat Development Plan and any other assays decided upon by the JSC pursuant to Section 3.7(c), and in the preparation and/or exchange of any documents necessary to support any INDs, NDAs, BLAs, PMAs or other applications for such Regulatory Approvals.
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of the Development Plan, and further acknowledge that requests from Regulatory Authorities may necessitate modifications to the Development Plan. The Parties agree that, as soon as practicable following the Effective Date, the initial Development Plan will be modified and made more comprehensive pursuant to direction and approval by the JSC, with the understanding that the JSC shall agree on a final design for the NSCLC POC Trial that meets the following criteria: (a) the NSCLC POC Trial shall enroll no less than [**] patients; (b) the NSCLC POC Trial shall be designed to cost no more than fifteen million U.S. dollars ($15,000,000), and (c) the NSCLC POC Trial shall be designed to meet regulatory requirements and conform with FDA feedback. Thereafter, as may be necessary from time-to-time, whether due to Regulatory Authority requests or otherwise, the JSC shall review proposed revisions to the Development Plan. If the JSC approves such revisions, then the JSC shall revise the Development Plan accordingly without need for amending this Agreement. The Parties shall not unreasonably withhold their consent to appropriate Development Plan revisions. The revised Development Plan shall thereafter be the Development Plan for all purposes of this Agreement.
(a) In connection with the Development Plan and with Biodesix’s activities under Article VII, AVEO shall furnish to Biodesix certain quantities of Clinical Specimens as agreed upon and set forth in the Development Plan or otherwise agreed upon by the JSC. Biodesix will comply with all applicable Laws relating to the Clinical Specimens. Without limiting the foregoing, to the extent that the Clinical Specimens include human specimens, AVEO represents and warrants to Biodesix that either it has obtained all informed consents and Institutional Review Board (IRB)/Ethics Committee (EC) approval(s) required by applicable Law with respect to such Clinical Specimens procured by AVEO or that it is not required under applicable Law to obtain such informed consents and/or has received a waiver for consent from an IRB/EC. Notwithstanding the foregoing, in the event of an Opt-Out by either Party, the provisions of Section 3.6 shall control.
(b) Biodesix agrees to retain possession of the Clinical Specimens and not to provide the Clinical Specimens to any Third Party (except for Third Parties conducting Development Plan activities pursuant to this Agreement and for whose performance and compliance with the terms of this Agreement Biodesix remains primarily liable to AVEO) or to use or permit the use of any of the Clinical Specimens for any purpose other than the Development of VeriStrat in accordance with this Agreement without the prior approval of the JSC. Notwithstanding the foregoing, in the event of an Opt-Out by either Party, the provisions of Section 3.6 shall control. ALL CLINICAL SPECIMENS ARE PROVIDED “AS IS” AND WITHOUT ANY REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR OF FITNESS FOR ANY PARTICULAR PURPOSE OR ANY WARRANTY THAT THE USE OF THE CLINICAL SPECIMENS WILL NOT INFRINGE OR VIOLATE ANY PATENT OR OTHER PROPRIETARY RIGHTS OF ANY THIRD PARTY.
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(c) AVEO will transmit to Biodesix the Clinical Data in the form of a Limited Data Set, which shall not contain any data that identifies or could be used to identify an individual (“Personal Data”). However, to the extent that Personal Data can be identified from any Clinical Specimens, participation in the Development Plan or otherwise, Biodesix shall hold in confidence all Personal Data except as required or permitted under this Agreement, or to the extent necessary to be disclosed to Regulatory Authorities as part of the review process. In addition, Biodesix shall comply with all applicable Laws with respect to the collection, use, storage, and disclosure of any Personal Data, including the U.S. Health Insurance Portability and Accountability Act (“HIPAA”), as amended, and the regulations promulgated thereunder, to the extent such Personal Data consists of Protected Health Information (PHI) as defined in HIPAA. Biodesix agrees to use commercially reasonable efforts to ensure that appropriate technical and organization measures are taken to protect Personal Data, including PHI, against loss, misuse, and any unauthorized, accidental, or unlawful access, disclosure, alteration, or destruction, including implementation and enforcement of administrative, technical, and physical security policies and procedures applicable to Personal Data and, to the extent applicable, PHI.
(a) Other than with respect to AVEO’s supply of Ficlatuzumab (which is governed by Section 3.3), Biodesix will reimburse AVEO for all Development Costs incurred by AVEO in connection with the conduct of the NSCLC POC Trial after the Effective Date in accordance with the NSCLC POC Trial Plan, up to an aggregate reimbursement of fifteen million U.S. dollars ($15,000,000) (the “Cap”), subject to reduction as set forth below for Development Costs incurred by Biodesix for the conduct of the NSCLC POC Trial with the approval of the JSC. If the NSCLC POC Trial Plan budget is modified such that the aggregate Development Costs to be incurred in conducting the NSCLC POC Trial will exceed the Cap, then such excess Development Costs shall constitute Additional Development Costs and shall be borne by the Parties as set forth in Section 3.5(b) below. If Biodesix incurs Development Costs in connection with the conduct of the NSCLC POC Trial with the approval of the JSC, Biodesix shall pay for such costs, such costs shall reduce the Cap, and, after the Cap has been reached, such costs incurred by Biodesix shall be included in Additional Development Costs and borne by the Parties as set forth in Section 3.5(b).
(b) Biodesix will reimburse AVEO for 50% of all Additional Development Costs incurred by AVEO. “Additional Development Costs” means: (i) all Development Costs incurred in conducting the NSCLC POC Trial Plan in excess of the Cap; (ii) all Development Costs associated with the Development of Ficlatuzumab under the Development Plan other than costs incurred in conducting the NSCLC POC Trial Plan; and (iii) Ficlatuzumab Cost of Goods for supply in excess of the Existing Supply of Ficlatuzumab. If Biodesix incurs Additional Development Costs with the approval of the JSC, such costs shall be reconciled with, and off-set from, as appropriate, the Additional Development Costs incurred by AVEO such that each Party bears 50% of the aggregate Additional Development Costs.
(c) Either Party may elect to Opt-Out solely after the earlier to occur of: (i) the Cap being reached or (ii) the completion of the NSCLC POC Trial, by providing [**] months written notice to the other Party (the “Opt-Out Notice”), but in no event may either Party Opt-Out after the First Commercial Sale of Ficlatuzumab. In the event a Party elects to Opt-Out, the Parties shall proceed as specified under Section 3.6. For the avoidance of doubt, neither Party has the right to Opt-Out except as expressly set forth in this Section 3.5(c). The effective date of any permitted Opt-Out shall be the date [**] months following the date the Opt-Out Notice is given to the other Party.
(a) If Biodesix elects to Opt-Out pursuant to Section 3.5(c), then, upon the expiration of the Opt-Out notice period: (i) Biodesix shall continue to be responsible hereunder for reimbursement of Development Costs as described in Sections 3.3 and 3.5 with respect to then-ongoing clinical trials under the Development Plan and with respect to any then-committed, non-cancellable Development Costs under the Development Plan; (ii) Biodesix shall have no further responsibility pursuant to Sections 3.3 or 3.5 except as set forth in the foregoing clause (i), provided that the Opt-Out election does not derogate from any accrued but unpaid obligations; (iii) Biodesix shall cease to be entitled to share in the profits and losses resulting from the Commercialization of Ficlatuzumab and shall instead be entitled to the Opt-Out Royalty; (iv) AVEO shall have sole discretion over the continued conduct of the Development Plan and shall have the right to amend the Development Plan without oversight or approval of the JSC or Biodesix; (v) Biodesix shall remain responsible for its Development obligations hereunder with respect to VeriStrat, including with respect to obtaining PMA approval of Veristrat as a Companion Diagnostic on a timeline previously approved by the JSC and consistent with the timeline for approval of Ficlatuzumab, and the Parties shall negotiate in good faith as set forth in Section 6.1 to enter into an agreement pursuant to which Biodesix will agree to perform the VeriStrat Commercialization obligations set forth in Exhibit B under “Veristrat Commercialization” and “Opt-Out” and AVEO shall continue to be responsible for reimbursing Biodesix for each VeriStrat test sold in a jurisdiction where AVEO commercializes Ficlatuzumab and Biodesix has not obtained reimbursement for VeriStrat in connection with Ficlatuzumab as and to the extent set forth in Section 7.4 below, but AVEO shall not otherwise be obligated to make payments to Biodesix in consideration for Biodesix’s performance of Biodesix’s Development and Commercialization obligations with respect to VeriStrat. For the avoidance of doubt, all of Biodesix’s obligations under Article VII shall continue in full force and effect notwithstanding any Opt-Out by Biodesix and the Parties will cooperate in good faith to establish a mutually acceptable method and process for exchanging the information necessary to coordinate the continued Development of Ficlatuzumab in connection with VeriStrat to the extent that AVEO desires to continue such development following such Opt-Out by Biodesix.
(b) If AVEO elects to Opt-Out pursuant to Section 3.5(c), then, upon the expiration of the Opt-Out notice period:
(i) Biodesix may, at its sole cost and expense, control the conduct of further Development of Ficlatuzumab (including obtaining Regulatory Approvals), and AVEO shall (A) transfer to Biodesix, subject to clause (B) below and Sections 3.4 and 9.2(c) herein, the Clinical Specimens, Clinical Data (including the applicable clinical database) and related
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EXECUTION VERSION
supporting documentation and (B) negotiate with Biodesix in good faith and grant an exclusive license, with rights to sub-license, to use the AVEO Intellectual Property to the extent reasonably necessary to enable Biodesix to Develop and Commercialize Ficlatuzumab, which license shall be granted at no additional cost (provided that such license shall be subject to the terms and conditions of the AVEO Third Party Agreements and, subject to the deduction of such costs from net sales described in the Opt-Out Royalty provisions of Exhibit B, Biodesix shall be obligated to make any and all payments due under the AVEO Third Party Agreements as identified herein by AVEO that relate to such license);
(ii) AVEO shall continue to be responsible for its share of Development Costs under Section 3.3 and Section 3.5 with respect to then-ongoing clinical trials under the Development Plan and with respect to any then-committed, non-cancellable Development Costs under the Development Plan;
(iii) AVEO shall transfer to Biodesix AVEO’s ownership of any regulatory filings and Regulatory Approvals relating to Ficlatuzumab (including related correspondence with Regulatory Authorities);
(iv) AVEO and Biodesix shall cooperate to transfer to Biodesix any then-ongoing clinical trials and Biodesix shall assume all responsibilities therefor;
(v) following the effective date of such Opt-Out, AVEO shall have no further responsibility pursuant to Sections 3.1 or 7.4;
(vi) AVEO shall cease to be entitled to share in the profits and losses resulting from the Commercialization of Ficlatuzumab and shall instead be entitled to the Opt-Out Royalty;
(vii) Biodesix shall have sole discretion over the continued conduct of the Development Plan and shall have the right to amend the Development Plan without oversight or approval of the JSC or AVEO; and
(viii) AVEO shall make the Existing Supply of Ficlatuzumab available to Biodesix for purposes of enabling Biodesix to complete the Development thereof at no charge, provided that any supply of Ficlatuzumab that is not Existing Supply of Ficlatuzumab shall be provided at a price of [**]% of AVEO’s Ficlatuzumab Cost of Goods therefor, pursuant to a supply agreement to be mutually agreed upon between the Parties upon such Opt-Out; provided further that AVEO shall have no obligation to supply Ficlatuzumab for longer than [**] months following the Opt-Out. At Biodesix’s request during such [**] month period and at Biodesix’s expense, AVEO shall use Commercially Reasonable Efforts to provide a technology transfer, including, if permitted by the terms thereof, the assignment of all AVEO Third Party Agreements requested by Biodesix, that enables Biodesix to continue the further Development and Commercialization of Ficlatuzumab in accordance with the Development Plan, this Agreement and/or the Commercialization Agreement. AVEO either has prior to the Effective Date or will following the Effective Date request from the counterparties to the AVEO Third Party Agreements amendments thereto or consents thereunder permitting assignments thereof to Biodesix in the circumstances described above, provided that (1) AVEO shall not be required to
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EXECUTION VERSION
pay any consideration or grant any concessions in order to obtain any such amendments or consents and (2) AVEO shall have no liability to Biodesix if the counterparties to the AVEO Third Party Agreements do not grant such amendments or consents.
In addition, during the Profit Sharing Phase:
(a) VeriStrat will be used as a selection assay with respect to Ficlatuzumab for the NSCLC POC Trial indication and will be the focus of a co-development BLA and PMA approval assuming that the NSCLC POC Trial using VeriStrat as a selection assay are positive (i.e., primary endpoints met), provided that an EGFR mutation assay may also be used and be required for Development for such indication. In addition, AVEO may use other assays solely for data in support of research, BLA application and drug marketing;
(b) For clinical trial activities occurring after the NSCLC POC Trial, Biodesix shall have the right, at Biodesix’s cost, to analyze any Ficlatuzumab clinical trial samples with VeriStrat or Biodesix technology.
(c) The JSC shall have final decision-making authority on any further Companion Diagnostic Development of VeriStrat in connection with Ficlatuzumab as well as other diagnostic tests and/or biomarkers which may be useful for Ficlatuzumab, with the understanding that the JSC will make decisions based on the totality of the data and scientific evidence, with the intent to optimize the value of Ficlatuzumab; provided, however, that, during the Profit Sharing Phase, the JSC shall give Biodesix the first opportunity (which opportunity may be provided through Biodesix’s participation in JSC deliberations), on a jurisdiction by jurisdiction basis, to develop and/or supply any and all diagnostic tests and/or biomarkers determined by the JSC to be useful for Ficlatuzumab, to the extent such development and/or supply is consistent with optimizing the value of Ficlatuzumab. For clarity, the Parties agree that such deliberations shall be biased in favor of Biodesix in the event that any non-Biodesix test also under consideration by the JSC is approximately equal in its potential to maximize the value of Ficlatuzumab to the potential offered by such Biodesix-test, provided that, the JSC’s decisions as to whether or not to permit Biodesix to provide any such development and/or supply shall be based on the JSC’s determination of whether or not such development and/or supply by Biodesix would be consistent with optimizing the value of Ficlatuzumab; and
(d) AVEO will notify Biodesix of any amendments to the AVEO Third-Party Agreements, including any amendments entered into after delivery of an Opt-Out Notice by AVEO.
ARTICLE IV - LICENSING AND LICENSE REVENUE SHARING
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EXECUTION VERSION
behalf of a Party, then (i) such agreement does not constitute a license agreement for which JSC approval is required under Section 4.1 and (ii) amounts received in connection with such agreement do not constitute License Income hereunder.
(a) During the Profit Sharing Phase, AVEO shall remit to Biodesix fifty percent (50%) of all License Income accruing to AVEO during such time period (i.e., the ‘Profit Share’ phase).
(b) For such time period after Biodesix exercises its Opt-Out (if any), AVEO shall remit to Biodesix [**] percent ([**]%) of License Income accruing to AVEO during such time period.
(c) For such time period after AVEO exercises its Opt-Out (if any), Biodesix shall remit to AVEO [**] percent ([**]%) of all License Income accruing to Biodesix during such time period.
(a) for amounts [**] or fewer days past due, the rate applied shall be the thirty-day U.S. dollar LIBOR rate effective for the date that payment was due (as published in The Wall Street Journal), computed for the actual number of days the payment was past due; and
(b) for amounts greater than [**] days past due, the rate applied shall be the thirty-day U.S. dollar LIBOR rate effective for the date that payment was due (as published in The Wall Street Journal) plus [**]% per annum, computed for the actual number of days the payment was past due.
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EXECUTION VERSION
ARTICLE VI - NEGOTIATION OF DEFINITIVE FICLATUZUMAB CO-COMMERCIALIZATION AGREEMENT
ARTICLE VII - VERISTRAT DEVELOPMENT AND COMMERCIALIZATION
(or its Affiliates) to timely complete its obligations under the VeriStrat Development Plan, except to the extent that (a) such failure or delay is caused by a delay or failure of performance by AVEO or a contract manufacturer, or (b) as may otherwise be mutually agreed in writing by the Parties.
(a) AVEO shall provide reimbursement in the amount of: (i) [**]% of the VeriStrat Cost of Goods if Biodesix has not submitted an application to the primary reimbursement authority in such jurisdiction, provided that, in no case shall such reimbursement obligation exceed $[**] per test; or (ii) $[**] per test if Biodesix has submitted such an application but has not obtained any such reimbursement approval, in either case such obligation to reimburse Biodesix not to exceed a period of [**] from First Commercial Sale in such jurisdiction, provided that the Parties will use Commercially Reasonable Efforts to modify such reimbursement structure, in all cases in a manner that is fully consistent with all applicable laws and regulations, on a jurisdiction by jurisdiction basis as and to the extent needed to comply with the regulatory requirements of such jurisdiction while continuing to compensate Biodesix for its commercial performance of VeriStrat consistent with the amount set forth herein. Biodesix shall
invoice AVEO the foregoing amounts on a calendar quarter basis for the VeriStrat tests performed during each such calendar quarter then ended. AVEO shall remit payment for each such invoice within [**] days of receipt.
(b) The mechanism for tracking the number of VeriStrat tests performed in any jurisdiction for purposes of screening patients for potential commercial use of Ficlatuzumab and payment by AVEO to Biodesix therefor, as mutually agreed upon by the Parties, shall be included in the Commercialization Agreement, where such mechanism may include: (i) information from VeriStrat order forms specifying the intention to test for the purpose of assessing Ficlatuzumab treatment candidacy, (ii) third party sources tracking Ficlatuzumab prescriptions such as IMS Health, and (iii) appropriate assumptions regarding the ratio of VeriStrat testing and Ficlatuzumab prescriptions, provided that any such mechanism shall in each case be determined so as to fully comply with applicable laws and regulations and the regulatory requirements of such jurisdiction while continuing to compensate for the commercial performance of VeriStrat consistent with the amount set forth herein.
(c) The Commercialization Agreement shall also include a periodic right for each Party to audit the other to ensure the accuracy of such tracking mechanism. If the Parties disagree regarding such number for any jurisdiction, then the Parties shall engage a qualified independent third party to determine the number of VeriStrat tests performed in such jurisdiction for purposes of screening patients for potential use of Ficlatuzumab during the time period that is the subject of the disagreement.
ARTICLE VIII - LICENSE GRANTS; RIGHT OF FIRST NEGOTIATION
8.1. Grants of Rights – Intellectual Property.
(a) AVEO hereby grants to Biodesix a perpetual, non-exclusive, non-transferable (except in connection with a permitted assignment of this Agreement), royalty-free license (i) under AVEO Intellectual Property and AVEO’s rights in Joint Inventions and Joint Patent Rights, to Develop, Manufacture and Commercialize VeriStrat and (ii) under AVEO Intellectual Property arising in the course of this Agreement and AVEO’s rights in Joint Inventions and Joint Patent Rights, to Develop, Manufacture and Commercialize IVD devices other than VeriStrat. Such license shall, subject to Article IV, include the right to grant sublicenses.
(b) Biodesix hereby grants to AVEO a perpetual, non-exclusive, non-transferable (except in connection with a permitted assignment of this Agreement), royalty-free license (i) under Biodesix Intellectual Property and Biodesix’s rights in Joint Inventions and Joint Patent Rights, to Develop, Manufacture and Commercialize Ficlatuzumab and (ii) under Biodesix Intellectual Property arising in the course of this Agreement and Biodesix’s rights in Joint Inventions and Joint Patent Rights, subject to Biodesix’s rights and AVEO’s obligations under Sections 3.7 and 8.5, to Develop, Manufacture and Commercialize IVD devices for use in connection with Ficlatuzumab. Such license shall, subject to Article IV, include the right to grant sublicenses.
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(a) AVEO agrees to grant and hereby grants to Biodesix a perpetual, non-exclusive, non-transferable (except in connection with a permitted assignment of this Agreement), royalty-free license to (i) use the Clinical Data generated prior to any Opt-Out by Biodesix and (ii) make reference to such Clinical Data in obtaining any Regulatory Approval, in the case of both (i) and (ii) in conformity with Biodesix’s rights and obligations under this Agreement, and in furtherance of Development, Manufacture and Commercialization of VeriStrat (“Clinical Data License”). Such license shall, subject to Article IV, include the right to grant sublicenses in connection with Biodesix’s licensing of VeriStrat, provided that Biodesix shall not practice such license or grant sublicenses thereunder in order to develop, or assist or permit any Affiliate or Third Party to develop, a Companion Diagnostic for any therapeutic product that inhibits HGF or c-Met signaling; provided further, however, that AVEO acknowledges and agrees that Biodesix’s commercial sale of Biodesix’s products in the ordinary course shall not be considered a violation of the restriction set forth in the immediately preceding proviso. AVEO acknowledges and agrees that, although such license is non-exclusive, AVEO’s rights to use and reference Clinical Data to develop IVD devices for use in connection with Ficlatuzumab remain subject to Sections 3.7 and 8.5.
(b) AVEO agrees to grant and hereby grants to Biodesix a perpetual, non-exclusive, non-transferable (except in connection with a permitted assignment of this Agreement), royalty-free license to the [**]. The [**] License shall grant Biodesix the right to [**] in obtaining any Regulatory Approval in conformity with Biodesix’s rights and obligations under this Agreement and in furtherance of [**].
(c) Biodesix hereby grants to AVEO a perpetual (subject to Section 3.6(b)), non-exclusive, non-transferable (except in connection with a permitted assignment of this Agreement), royalty-free license to use and reference Diagnostic Data generated prior to any Opt-Out by AVEO in obtaining any Regulatory Approval in conformity with AVEO’s rights and obligations under this Agreement and to Develop, Manufacture and Commercialize Ficlatuzumab and, subject to Biodesix’s rights and AVEO’s obligations under Sections 3.7 and 8.5, including, subject to Article IV, the right to grant sublicenses in connection with AVEO’s licensing of Ficlatuzumab (“Diagnostic Data License”).
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EXECUTION VERSION
ARTICLE IX - INTELLECTUAL PROPERTY
(a) Existing Inventions. AVEO shall retain ownership of all AVEO Intellectual Property owned by AVEO as of the Effective Date or as arising outside of this Agreement. Biodesix shall retain ownership of all Biodesix Intellectual Property owned by Biodesix as of the Effective Date or as arising outside of this Agreement.
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rights to such Joint Inventions in the commercial furtherance of both Ficlatuzumab and VeriStrat equally rather than in the interests of Ficlatuzumab alone and (ii) during the Opt-Out Phase that are not an AVEO Sole Invention or a Biodesix Sole Invention shall be owned by the respective Parties in accordance with, and the respective Parties’ rights thereto shall be governed by, applicable United States patent laws and laws governing inventorship.
9.2. Ownership of Data; Ownership and License to Clinical Specimens.
(a) As between the Parties, AVEO shall solely own all [**] and [**], and Biodesix agrees to assign and hereby does assign all right, title and interest in and to such [**] to AVEO; provided that, [**] and [**] generated by the Parties following an Opt-Out by AVEO shall be owned by Biodesix.
(b) As between the Parties, Biodesix shall solely own all [**] and AVEO agrees to assign and hereby does assign all right, title and interest in and to [**] to Biodesix.
(c) AVEO shall solely own all Clinical Specimens, and hereby grants to Biodesix a limited, non-exclusive right to use the Clinical Specimens for the purpose of Development and Commercialization of VeriStrat or any other in vitro diagnostic assay, but such ownership and license rights shall be subject to the Parties’ rights and obligations with respect to any [**] and [**] derived from such Clinical Specimens, as set forth in
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Sections 8.2 and 9.2(a). Notwithstanding the Parties’ respective ownership and license rights as to the Clinical Specimens, each Party’s use of the Clinical Specimens during the Profit-Sharing Phase shall be subject to the prior approval of the JSC, such approval not to be unreasonably withheld, and at all times shall be subject to the terms of the applicable patient informed consents.
9.3. Prosecution and Maintenance of Patent Rights.
9.4. Third Party Infringement.
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EXECUTION VERSION
Ficlatuzumab, then, subject to the terms of the AVEO Third Party Agreements, the other Party shall have the option to take such action or bring such suit with respect to the Patent Rights or Know-How.
Each Party shall bear its own expense of any suit it brings or is brought against it in relation to any Solely owned Patent Right or Know-How pursuant to this Section 9.4(b). Each Party will reasonably cooperate with the other, at its expense, and shall have the right to consult with, and to participate in and be represented by, independent counsel in such litigation at its own expense. Any recoveries obtained by either Party as a result of any such proceedings shall be allocated as follows: (A) such recovery shall first be used to reimburse each Party for all reasonable attorney fees and other litigation costs actually incurred in connection with such litigation by that Party, and (B) any remainder shall be allocated [**] percent ([**]%) to the enforcing Party and [**] percent ([**]%) to the non-enforcing Party.
(a) Each of the Parties shall promptly notify the other in the event of any legal or administrative action by any Third Party against a Joint Patent Right or an AVEO Patent Right claiming Ficlatuzumab, of which it becomes aware, including any opposition, nullity, revocation, reexamination or compulsory license proceeding.
(b) AVEO shall have the first right, but not the obligation, to defend against any such action involving a Joint Patent Right or an AVEO Patent Right in connection with Ficlatuzumab. If AVEO does not defend against any such action involving such Joint Patent Right or AVEO Patent Right owned by AVEO pursuant to Section 9.1(b), then Biodesix shall have the right, but not the obligation, to defend such action. Biodesix shall have the sole right, but not the obligation, to defend against any such action involving a Biodesix Patent Right.
(c) Each non-defending Party agrees to cooperate reasonably with the defending Party, at the request of the defending Party, in connection with such defense of a Joint Patent Right or an AVEO Patent Right in connection with Ficlatuzumab, including by joining in any such action. The out-of-pocket costs and expenses incurred in connection with such defense and cooperation shall be borne fifty percent (50%) by Biodesix and fifty percent (50%) by AVEO, regardless of which Party controls such defense.
(a) Biodesix shall have sole and exclusive control of branding and trademark rights with respect to VeriStrat, subject to any co-promotion and cobranding activities of Ficlatuzumab and Veristrat in connection with Ficlatuzumab as determined by the JSC.
(b) AVEO shall have sole and exclusive control of branding and trademark rights with respect to Ficlatuzumab, subject to any co-promotion and cobranding activities of Ficlatuzumab and Veristrat in connection with Ficlatuzumab as determined by the JSC.
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ARTICLE X - CONFIDENTIAL INFORMATION
(a) either before or after the date of the disclosure to the receiving Party is lawfully disclosed to the receiving Party by Third Parties without any violation of any obligation to the other Party;
(b) either before or after the date of the disclosure to the receiving Party, becomes published or generally known to the public through no fault or omission on the part of the receiving Party or its Agents; or
(c) is independently developed by or for the receiving Party without reference to or reliance upon the Confidential Information as demonstrated by contemporaneous written records of the receiving Party.
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ARTICLE XI - REPRESENTATIONS, WARRANTIES AND COVENANTS
(a) AVEO has the corporate power and authority to execute and deliver this Agreement and to perform its obligations hereunder. The execution, delivery and performance of this Agreement has been duly and validly authorized and approved by proper corporate action on the part of AVEO. AVEO has taken all other action required by applicable Law, its certificate of incorporation or by-laws or any agreement to which it is a party or by which it or its assets are bound, to authorize such execution, delivery and (subject to obtaining all necessary governmental approvals with respect to the continued Development of Ficlatuzumab) performance. Assuming due authorization, execution and delivery on the part of Biodesix, this Agreement constitutes a legal, valid and binding obligation of AVEO, enforceable against AVEO in accordance with its terms.
(b) The execution and delivery of this Agreement by AVEO and the performance by AVEO contemplated hereunder will not violate (subject to obtaining all necessary governmental approvals with respect to AVEO’s obligations under the Development Plan) any United States Law or, to AVEO’s knowledge, any Law outside the United States.
(c) Neither the execution and delivery of this Agreement nor the performance hereof by AVEO requires AVEO to obtain any permit, authorization or consent from any Regulatory Authority (subject to obtaining all necessary governmental approvals with respect to the Development Program activities) or from any other Person, and such execution, delivery and performance by AVEO will not result in the breach of or give rise to any encumbrance, termination of, rescission, renegotiation or acceleration under or trigger any other rights under any agreement or contract to which AVEO may be a party that relates to Ficlatuzumab or the AVEO Intellectual Property Rights, except any that would not, individually or in the aggregate, reasonably be expected to adversely affect Biodesix’s rights under this Agreement or the ability of AVEO to perform its obligations under this Agreement.
(d) AVEO represents that neither AVEO nor, to AVEO’s knowledge, any Person controlling (as such term is used in Section 1.1 above) AVEO has ever been convicted of a criminal offense, assessed civil monetary penalties pursuant to the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, or excluded from the Medicare program or any state healthcare program. AVEO further represents that neither AVEO nor, to AVEOs knowledge, any Person controlling (as such term is used in Section 1.1 above) AVEO is subject to an action or investigation that could lead to the conviction of a criminal offense, the assessment of civil monetary penalties pursuant to the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, or exclusion from the Medicare program or any state healthcare program. AVEO shall notify Biodesix within [**] days if an action or investigation results in such a conviction, assessment or exclusion. In the event that AVEO becomes excluded during the Term of the Agreement, Biodesix shall be entitled to terminate the Agreement effective immediately.
(e) It is not contemplated that Biodesix will transmit to AVEO any Personal Data. However, to the extent that Personal Data can be identified from any transmitted data,
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EXECUTION VERSION
participation in the Development Plan or otherwise, AVEO shall hold in confidence all Personal Data except as required or permitted under this Agreement, or to the extent necessary to be disclosed to Regulatory Authorities as part of the review process. In addition, AVEO shall comply with all applicable Laws with respect to the collection, use, storage, and disclosure of any Personal Data, including the U.S. Health Insurance Portability and Accountability Act (HIPAA), as amended, and the regulations promulgated thereunder, to the extent such Personal Data consists of Protected Health Information (PHI) as defined in HIPAA. AVEO agrees to use commercially reasonable efforts to ensure that all appropriate technical and organization measures are taken to protect Personal Data, including PHI, against loss, misuse, and any unauthorized, accidental, or unlawful access, disclosure, alteration, or destruction, including implementation and enforcement of administrative, technical, and physical security policies and procedures applicable to Personal Data and, to the extent applicable, PHI.
(f) AVEO possesses all rights in the Existing Supply of Ficlatuzumab necessary to transfer the Existing Supply of Ficlatuzumab to Biodesix or Third Parties such that it will be free and clear of any and all liens, mortgages, charges, security interests, pledges or other encumbrances or adverse claims of any nature, whether arising by agreement, operation of law or otherwise (collectively, “Liens”) upon such transfer.
(g) AVEO has performed reasonable diligence on its suppliers, and shall continue to perform such due diligence and negotiate appropriate terms with respect to quality with its suppliers as necessary to meet such quality standards as required by Regulatory Authorities, which quality requirements shall be further detailed in the Development Plan. AVEO shall not knowingly, and shall take commercially reasonable steps during the Term to ensure its suppliers shall not, provide any counterfeit, adulterated or misbranded Product; and shall immediately inform Biodesix following its receipt of any information which states that the integrity or legal status of any Product provided hereunder has been called into question by any retailer, wholesaler, or state or federal authority, or that any Product contributed to the Development hereunder is suspected of being counterfeit, stolen, adulterated, misbranded or otherwise an unlawful product and shall provide Biodesix with prompt written confirmation of any such event, including copies of any all documents related thereto.
(h) Except as disclosed by AVEO to Biodesix in writing, to AVEO’s knowledge, use of Ficlatuzumab in accordance with this Agreement shall not infringe upon any ownership rights of any Third Party or upon any patent, copyright, trademark, or other intellectual property or proprietary right or trade secret of any Third Party.
(i) The Manufacture for Ficlatuzumab does not relate to, derive from, or include the use of [**], or [**] per se or as relevant to trigger any licensing rights or obligations as provided under the [**] Agreement, in each case which would prevent the use of Ficlatuzumab by the Parties as expressly contemplated under this Agreement.
(j) Under the terms of the [**] Agreement, use of Product and [**] (each as defined in the [**] Agreement) sourced from [**] to [**] does not require the payment of any fees, or remuneration of any type, to [**] other than the transfer price paid to [**] for such Product and [**].
(k) Except as set forth on Schedule 11.1(k), the Development or Commercialization of Ficlatuzumab pursuant hereto shall not require payment to any counterparty to the AVEO Third Party Agreements or to any other agreement with a Third Party to which AVEO is a party relating to such counterparty’s Intellectual Property.
(l) The license of all AVEO Intellectual Property, Clinical Data and Biomarker Data, or the continued Development or Commercialization of Ficlatuzumab by Biodesix in the event of an Opt-Out by AVEO, does not and will not require the consent, notice or other action by any Person under, conflict with, result in a violation or breach of, constitute a default or an event that, with or without notice or lapse of time or both, would constitute a default under, result in the acceleration of or create in any Person the right to accelerate, terminate, modify or cancel, any contract to which AVEO is a party that relates to Ficlatuzumab. Except as set forth on Schedule 8.1(c), no contract to which AVEO is a party, including the AVEO Third Party Agreements, shall limit or otherwise impact, in any material respect, the scope of the rights granted by AVEO to Biodesix or the scope of the obligations owed by AVEO to Biodesix pursuant hereto.
(m) The prosecution, maintenance and enforcement of any and all AVEO Patent Rights solely owned by AVEO pursuant to Section 9.1(b) are not subject to the terms and conditions of any of the Third Party Agreements.
(a) Biodesix has the corporate power and authority to execute and deliver this Agreement and to perform its obligations hereunder. The execution, delivery and performance of this Agreement has been duly and validly authorized and approved by proper corporate action on the part of Biodesix. Biodesix has taken all other action required by applicable Law, its certificate of incorporation or by-laws or any agreement to which it is a party or by which it or its assets are bound to authorize such execution, delivery and (subject to obtaining all necessary governmental approvals with respect to the continued Development, Manufacture and Commercialization of VeriStrat) performance. Assuming due authorization, execution and delivery on the part of AVEO, this Agreement constitutes a legal, valid and binding obligation of Biodesix, enforceable against Biodesix in accordance with its terms.
(b) The execution and delivery of this Agreement by Biodesix and the performance by Biodesix contemplated hereunder will not violate (subject to obtaining all necessary governmental approvals with respect to the continued Development, Manufacture and Commercialization of VeriStrat) any United States applicable Law or, to Biodesix’s knowledge, any applicable Law outside the United States.
(c) Neither the execution and delivery of this Agreement nor the performance hereof by Biodesix requires Biodesix to obtain any permit, authorization or consent from any Regulatory Authority (subject to obtaining all necessary governmental approvals with respect to the continued Development, Manufacture and Commercialization of VeriStrat) or from any other Person, and such execution, delivery and performance by Biodesix will not result in the breach of or give rise to any termination of, rescission, renegotiation or acceleration under or trigger any
other rights under any agreement or contract to which Biodesix may be a party that relates to VeriStrat or the Biodesix Intellectual Property Rights, except any that would not, individually or in the aggregate, reasonably be expected to adversely affect AVEO’s rights under this Agreement or the ability of Biodesix to perform its obligations under this Agreement
(d) Biodesix represents that neither Biodesix nor, to Biodesix’ knowledge, any Person controlling (as such term is used in Section 1.1 above) Biodesix has ever been convicted of a criminal offense, assess civil monetary penalties pursuant to the Civil Monetary Penalties Law, 42 U.S.C. § 1320a-7a, or excluded from the Medicare program or any state healthcare program. Biodesix further represents that neither Biodesix nor, to Biodesix’ knowledge, any Person controlling (as such term is used in Section 1.1 above) Biodesix is subject to an action or investigation that could lead to the conviction of a criminal offense, the assessment of civil monetary penalties pursuant to the Civil Monetary Penalties Law, or exclusion from the Medicare program or any state healthcare program. Biodesix shall notify AVEO within [**] days if an action or investigation results in such a conviction, assessment or exclusion. In the event that Biodesix becomes excluded during the Term of the Agreement, AVEO shall be entitled to terminate the Agreement effective immediately.
Each of AVEO and Biodesix (the “Declaring Party”) warrants and represents to the other Party that neither the Declaring Party nor any of the Declaring Party’s officers, directors, employees, agents, subcontractors or other representatives has performed or will perform during the Term of this Agreement any of the following acts in connection with this Agreement, any compensation paid or to be paid hereunder, any payment made or to be made hereunder, or any other transactions involving the business interests of either AVEO or Biodesix: offer or promise to pay, or authorize the payment of, any money, or give or promise to give, or authorize the giving of, any services or anything else of value, either directly or through a third party, to any officer or employee of a public international organization (as designated under 22 U.S.C. § 288) or of any government or governmental instrumentality within the Territory, or of any agencies or subdivisions thereof, or to any political party or official thereof or to any candidate for political office for the purpose of (i) influencing any act or decision of that person in his official capacity, including a decision to fail to perform his official functions with such government or instrumentalities, (ii) inducing such person to use his influence with such government or instrumentalities to affect or influence any act or decision thereof or (iii) securing any improper advantage.
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ARTICLE XII - INDEMNIFICATION AND INSURANCE
(a) any breach of any representation, warranty, covenant or agreement made by Biodesix in this Agreement;
(b) any violation of applicable Law by Biodesix in connection with activities undertaken by Biodesix relating to Development Plan activities or the VeriStrat Development Plan;
(c) the gross negligence or willful misconduct of any of the Biodesix Parties (as hereinafter defined) in connection with Biodesix’s performance of this Agreement; or
(d) the Development, Manufacture, use or Commercialization of VeriStrat in connection with Ficlatuzumab.
For purposes of this Article XII, “AVEO Parties” means AVEO, its Affiliates and their respective licensors, agents, directors, officers, employees and shareholders.
The indemnification obligations set forth in this Section 12.1 shall not apply to the extent that any Loss is the result of a breach of this Agreement by AVEO or, with respect to any indemnitee, the gross negligence or willful misconduct of such indemnitee.
(a) any breach of any representation, warranty, covenant or agreement made by AVEO in this Agreement;
(b) any violation of applicable Law by AVEO in connection with activities undertaken by AVEO relating to Development Plan activities or Ficlatuzumab;
(c) the gross negligence or willful misconduct of any of the AVEO Parties in connection with AVEO’s performance of its obligations under this Agreement; or
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EXECUTION VERSION
(d) the costs of defending any litigation regarding alleged infringement claims arising from the matters disclosed by AVEO to Biodesix in writing, it being agreed that (i) AVEO shall be responsible for all costs associated with litigating such alleged infringement claims, including defenses and counterclaims asserted against the Parties to such infringement suits, and shall indemnify Biodesix therefor and shall control the defense and settlement thereof, and (ii) in the event the resolution of such alleged infringement claims results in a settlement or a judgment awarding infringement damages to a Third Party plaintiff thereunder, Biodesix agrees to share the costs of such settlement or damages award, including the costs of any license resulting from such settlement or entered into in connection with the satisfaction of such damages award, with AVEO on an equal basis.
For purposes of this Article XII, “Biodesix Parties” means Biodesix, its Affiliates and their respective agents, directors, officers, employees and shareholders.
The indemnification obligations set forth in this Section 12.2 shall not apply to the extent that any Loss is the result of a breach of this Agreement by Biodesix or, with respect to any indemnitee, the gross negligence or willful misconduct of such indemnitee.
12.3. General Indemnification Procedures.
(a) A Person seeking indemnification pursuant to this Article XII (an “Indemnified Party”) shall give prompt notice to the Party from whom such indemnification is sought (the “Indemnifying Party”) of the commencement or assertion of any Third Party Claim (which in no event includes any claim by any Biodesix Party or any AVEO Party) in respect of which indemnity may be sought hereunder, shall give the Indemnifying Party such information with respect to any indemnified matter as the Indemnifying Party may reasonably request, and shall not make any admission concerning any Third Party Claim, unless such admission is required by applicable Law or legal process, including in response to questions presented in depositions or interrogatories. Any admission made by the Indemnified Party or the failure to give such notice shall relieve the Indemnifying Party of any liability hereunder only to the extent that the ability of the Indemnifying Party to defend such Third Party Claim is prejudiced thereby (and no admission required by applicable Law or legal process shall be deemed to result in prejudice). The Indemnifying Party shall assume and conduct the defense of such Third Party Claim, with counsel selected by the Indemnifying Party and reasonably acceptable to the Indemnified Party. Subject to the initial and continuing satisfaction of the terms and conditions of this Article XII, the Indemnifying Party shall have full control of such Third Party Claim, including settlement negotiations and any legal proceedings. If the Indemnifying Party does not assume the defense of such Third Party Claim in accordance with this Section 12.3, the Indemnified Party may defend the Third Party Claim. If both Parties are Indemnifying Parties with respect to the same Third Party Claim, the Parties shall determine by mutual agreement, within [**] days following their receipt of notice of commencement or assertion of such Third Party Claim (or such lesser period of time as may be required to respond properly to such claim), which Party shall assume the lead role in the defense thereof. Should the Indemnifying Parties be unable to mutually agree on which of them shall assume the lead role in the defense of such Third Party Claim, both Indemnifying Parties shall be entitled to participate in such defense through counsel of their respective choosing.
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EXECUTION VERSION
(b) Any Indemnified Party or Indemnifying Party not managing the defense of a Third Party Claim shall have the right to participate in (but not control), at its own expense (subject to the immediately succeeding sentence), the defense. The Indemnifying Party managing the defense shall not be liable for any litigation cost or expense incurred, without its consent, by the Indemnified Party (or an Indemnifying Party not managing the defense) where the action or proceeding is under the control of such Indemnifying Party; provided, however, that if the Indemnifying Party managing the defense fails to take reasonable steps necessary to defend such Third Party Claim, the Indemnified Party may assume its own defense, and the Indemnifying Party managing the defense will be liable for all reasonable costs or expenses paid or incurred in connection therewith.
(c) The Indemnifying Party shall not consent to a settlement of, or the entry of any judgment against an Indemnified Party arising from any such Third Party Claim to the extent such Third Party Claim involves equitable or other non-monetary relief from the Indemnified Party. The Indemnifying Party shall not, without the prior written consent of the Indemnified Party, enter into any compromise or settlement that commits the Indemnified Party to take, or to forbear to take, any action.
(d) The Parties shall cooperate in the defense or prosecution of any Third Party Claim and shall furnish such records, information and testimony, and attend such conferences, discovery proceedings, hearings, trials and appeals, as may be reasonably requested in connection therewith.
ARTICLE XIII - TERM AND TERMINATION
13.4. Effect of Termination and Expiration; Accrued Rights and Obligations.
(a) In the event of termination of this Agreement by AVEO under Section 13.2 or Section 13.3: (a) if such termination is effective prior to the earliest time at which Biodesix is entitled to Opt-Out pursuant to Section 3.5(c), then following such termination Biodesix shall not be entitled to receive any royalties, share of License Income, share of profits and losses or any other payments of any kind relating to Ficlatuzumab under this Agreement, the Commercialization Agreement or otherwise; and (b) if such termination is effective after the earliest time at which Biodesix is entitled to Opt-Out pursuant to Section 3.5(c), then Biodesix shall be deemed to have validly exercised its Opt-Out right as authorized under Section 3.5(c) effective as of the termination date for all purposes hereunder.
(b) In the event of termination of this Agreement by Biodesix under Section 13.2 or Section 13.3, which breach (or the event underlying such breach) does not prevent or irreparably disrupt the completion of the NSCLC POC Trial, then AVEO shall be deemed to have validly exercised its Opt-Out right as authorized under Section 3.5(c) effective as of the termination date for all purposes hereunder. In the event of termination of this Agreement by Biodesix under Section 13.2 or Section 13.3, which breach (or the event underlying such breach) prevents or irreparably disrupts the completion of the NSCLC POC Trial, then AVEO shall be deemed to have validly exercised its Opt-Out right as authorized under Section 3.5(c) effective as of the termination date for all purposes hereunder, except that AVEO shall be entitled to an Opt-Out Royalty of [**]% of the otherwise applicable Opt-Out Royalty. In the event of
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EXECUTION VERSION
termination of this Agreement by Biodesix under Section 13.2 or 13.3, Biodesix shall have no further obligations hereunder with respect to the VeriStrat Development Plan. Biodesix’s obligations relating to the VeriStrat Development Plan hereunder shall survive in the event of any termination of this Agreement other than a termination by Biodesix pursuant to Section 13.2 or 13.3.
(c) Termination of this Agreement for any reason shall not release either Party from any liability that, at the time of such termination, has already accrued or that is attributable to a period prior to such termination (including payment obligations accrued prior to the effective date of termination) nor preclude either Party from pursuing any right or remedy it may have hereunder or at Law or in equity with respect to any breach of this Agreement. It is understood and agreed that monetary damages may not be a sufficient remedy for any breach of this Agreement and that the non-breaching Party may be entitled to seek injunctive relief as a remedy for any such breach.
ARTICLE XIV - DISPUTE RESOLUTION
(a) If the Parties are unable to resolve such dispute as provided in Section 14.1, either Party may submit such dispute to arbitration by notifying the other Party, in writing, of such dispute. Within [**] days after receipt of such notice, the Parties shall designate in writing a single arbitrator to resolve the dispute; provided, however, that if the Parties cannot agree on an arbitrator within such [**] day period, the arbitrator shall be selected by the New York, New York office of the American Arbitration Association (the “AAA”). The arbitrator shall be a lawyer knowledgeable and experienced in the law concerning the subject matter of the dispute, and shall not be an Affiliate, employee, consultant, officer, director or stockholder of any Party.
(b) Within [**] days after the designation of the arbitrator, the arbitrator and the Parties shall meet, at which time the Parties shall be required to set forth in writing all disputed issues and a proposed ruling on the merits of each such issue.
(c) The arbitrator shall set a date for a hearing, which shall be no later than [**] days after the submission of written proposals pursuant to Section 14.2(b), to discuss each of the issues identified by the Parties. The Parties shall have the right to be represented by counsel. Except as provided herein, the arbitration shall be governed by the Commercial Arbitration Rules of the AAA; provided, however, that the Federal Rules of Evidence shall apply with regard to the admissibility of evidence.
(d) The arbitrator shall use his or her best efforts to rule on each disputed issue in an expeditious manner. The determination of the arbitrator as to the resolution of any dispute shall be binding and conclusive upon the Parties. All rulings of the arbitrator shall be in writing and shall be delivered to the Parties.
(e) The (i) attorneys’ fees of the Parties in any arbitration, (ii) fees of the arbitrator and (iii) costs and expenses of the arbitration shall be borne by the Parties as determined by the arbitrator.
(f) Any arbitration pursuant to this Section 14.2 shall be conducted in New York, New York. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be.
15.1. Governing Law. This Agreement and any dispute arising from the performance or breach of this Agreement shall be governed by, construed and enforced in accordance with the Laws of the State of Delaware, without regard to its conflicts of laws rules. The provisions of the United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement or any subject matter hereof.
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and shall be: (a) delivered personally; (b) sent by registered or certified mail, return receipt requested, postage prepaid; (c) sent via a reputable nationwide overnight courier service; or (d) sent by facsimile transmission or electronic mail. Any such notice, instruction or communication shall be deemed to have been delivered upon receipt if delivered by hand, three (3) Business Days after it is sent by registered or certified mail, return receipt requested, postage prepaid, one (1) Business Day after it is sent via a reputable nationwide overnight courier service, or when transmitted with electronic confirmation of receipt, if transmitted by facsimile or email (if such transmission is on a Business Day; otherwise, on the next Business Day following such transmission).
Notices to Biodesix shall be addressed to: |
Biodesix, Inc. |
0000 Xxxxxxxxxx Xxxxx, Xxxxx 000 Xxxxxxx, Xxxxxxxx 00000 |
Attention: Legal and Regulatory Affairs Telephone: (000) 000-0000 |
Facsimile: (000) 000-0000 |
With copies to (which shall not constitute notice): |
Biodesix, Inc. |
0000 Xxxxxxxxxx Xxxxx, Xxxxx 000 Xxxxxxx, Xxxxxxxx 00000 |
Attention: Business Development Telephone: (000) 000-0000 |
Facsimile: (000) 000-0000 |
Notices to AVEO shall be addressed to: |
AVEO Pharmaceuticals, Inc. 000 X. Xxxxxxx Xxxxxx Xxxxxxxxx, XX 00000 Attention: Chief Business Officer Facsimile: (000) 000-0000 |
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with a copy to: |
Xxxxxx Xxxxxx Xxxxxxxxx Xxxx and Xxxx LLP 00 Xxxxx Xxxxxx Xxxxxx, XX 00000 Attention: Xxxxxx X. Xxxxxxx, Esq. Facsimile: (000) 000-0000 |
Either Party may change its address by giving notice to the other Party in the manner provided above.
15.8. Assignment; Change of Control.
Neither this Agreement nor any right or obligation hereunder may be assigned or otherwise transferred by any Party without the consent of the other Party, which shall not be unreasonably withheld; provided, however, that any Party may, without such consent, assign this Agreement: (a) in whole or in part to any of its respective Affiliates; provided that such Party shall remain primarily liable in respect of all obligations so assigned and such Affiliate has
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acknowledged and confirmed in writing that effective as of such assignment or other transfer, such Affiliate shall be bound by this Agreement as if it were a party to it as and to the identical extent applicable to the transferor; or (b) to any successor in interest by way of a Change of Control, acquisition or sale of all or substantially all of its assets relating to the subject matter of this Agreement (where any such transaction shall constitute an attempted assignment of this Agreement) provided that (1) such Party shall remain primarily liable in respect of all obligations so assigned and such successor has acknowledged and confirmed in writing that effective as of such assignment or other transfer, such successor shall be bound by this Agreement as if it were a party to it as and to the identical extent applicable to the transferor; (2) such successor agrees in writing to be bound by the terms of this Agreement as if it were the assigning party and (3) such successor agrees in writing to be bound by the terms of Section 15.8(b). Upon a Change of Control of either Party and upon an assignment of this Agreement in its entirety by either Party, the Party or the assignee, as the case may be, agrees to: (a) use Commercially Reasonable efforts to satisfy the Development or Commercialization timeline (e.g., XXXX chart) then approved by the JSC and in effect; and (b) use no less effort in the performance of the Party’s or the assigning Party’s, as applicable, obligations hereunder than the Party or the assigning Party, as applicable, was itself using prior to such transaction.
In addition, any purported assignment in violation of this Section 15.8 shall be void. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement.
Notwithstanding anything to the contrary in this Agreement, if a Party to this Agreement is acquired or otherwise becomes directly or indirectly “controlled” (as such term is defined for purposes of Section 1.1) by one or more entities that were not Affiliates of such Party as of the Effective Date, the Know-How and Patent Rights of such acquiring or otherwise controlling entity(-ies) shall not be subject to the rights and licenses granted to the other Party under this Agreement, except to the extent such acquiring or otherwise controlling entity(-ies) participate in activities pursuant to this Agreement, in which case the Know-How and Patent Rights that such entity(-ies) generate in the conduct of such activities shall be subject to the rights and licenses granted to the other Party under this Agreement.
[Remainder of page intentionally left blank.]
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IN WITNESS WHEREOF, the Parties hereto have set their hand as of the date first above written.
AVEO PHARMACEUTICALS, INC. | BIODESIX, INC. | |||||||
By: | /s/ Xxxx Xx-Xxxx |
By: | /s/ Xxxxx Xxxxxx | |||||
Title: President and CEO | Title: Chief Executive Officer |
[SIGNATURE PAGE TO THE CO-DEVELOPMENT
AND COLLABORATION AGREEMENT]
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NSCLC POC Trial
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. [**]
SUMMARY OF TERMS OF COMMERCIALIZATION AGREEMENT
Ficlatuzumab Commercialization during the Profit-Sharing Phase | AVEO shall be the lead commercialization party, including being responsible for medical affairs, reimbursement services, pricing, general product supply and distribution, selection of service providers, sales operations, and training and marketing; provided that, the Joint Commercialization Committee will agree on all material decisions relating thereto. AVEO shall book sales of Ficlatuzumab worldwide. Commercial budgets and allocation of activities shall be jointly agreed to by the Joint Commercialization Committee, with the understanding that Biodesix and AVEO shall each have the right to co-promote Ficlatuzumab and provide up to 50% of the requisite sales efforts. | |
Veristrat Commercialization | Except following an Opt-Out by AVEO, (a) Biodesix shall use Commercially Reasonable Efforts to Commercialize VeriStrat as a companion diagnostic for Ficlatuzumab in each of the Major Market jurisdictions, in each case on a timeline that is consistent with the timeline for Commercialization activities for Ficlatuzumab in such jurisdiction, (b) Biodesix shall continue to make VeriStrat commercially available in each such jurisdiction for so long as Ficlatuzumab is made available in such jurisdiction, (c) subject to applicable law in the relevant jurisdiction, Biodesix shall exercise Commercially Reasonable Efforts to adopt a pricing strategy for VeriStrat that does not adversely affect the uptake of Ficlatuzumab in such jurisdiction and (d) Biodesix shall use Commercially Reasonably Efforts to obtain third-party payor reimbursement approval (which, in the United States, shall be deemed to include Medicare reimbursement) in each such jurisdiction as soon as it is eligible to do so.
Except following an Opt-Out by AVEO, the terms and conditions of Section 7.4 of the Agreement are hereby incorporated by reference thereto. | |
Profit Sharing during the Profit-Sharing Phase | AVEO and Biodesix shall share the profits and losses resulting from commercialization of Ficlatuzumab by AVEO and Biodesix worldwide on a 50/50 basis, it being understood that (without limitation) all:
(i) inventory build-up and costs associated with launch preparation, (ii) amounts paid to third parties, including for the licensing of intellectual property and/or infringement liability (including pursuant to the AVEO Third Party Agreements), (iii) intellectual property registration, prosecution and maintenance expenses, (iv) recall and product liability costs, (v) manufacturing and supply costs, (vi) sales force and promotional costs, (vii) distribution costs, (viii) regulatory affairs and pharmacovigilance costs, (ix) medical affairs and medical science liaison costs, and (x) costs of post-approval clinical studies (e.g., phase IIIb and |
phase IV studies), which are incurred subsequent to the Effective Date and related to sale of Ficlatuzumab shall be treated as expenses in calculating such profits and losses. For the avoidance of doubt, the foregoing expenses shall include both internal and external expenses. The JSC will oversee all budgets for commercial expenses, including manufacturing and supply and sales force and promotional budgets. | ||
Opt-Out | If either party exercises its Opt-Out right as permitted in the Agreement, then the Opt-Out party shall not be responsible for sharing, or have the right to share, in profits and losses, in which event (i) the other party can elect to proceed without the Opt-Out party’s participation and have sole decision making authority over the commercialization of Ficlatuzumab, (ii) the Opt-Out party will receive the Opt-Out Royalty, which shall be a royalty of [**]% of net sales of Ficlatuzumab made by the non-Opt-Out party or its Affiliates (which net sales shall not include License Income), using a net sales definition that is typical in therapeutic product licensing agreements and (iii) if AVEO is the Opt-Out Party, AVEO shall have no further obligation pursuant to the Agreement except for obligations under Section 7.4 which accrued prior to the effective date of such Opt-Out. Notwithstanding the foregoing, if: (a) Ficlatuzumab becomes subject to Follow-On Biologic Competition in a country during the applicable royalty period in such country; (b) all Patent Rights covering Ficlatuzumab in such country have expired; (c) all regulatory exclusivity for Ficlatuzumab in such country has expired; (d) there is a [**]% minimum threshold of market penetration by the follow-on biologic product(s); and (e) where such Follow-On Biologic Competition is otherwise not the result of entry authorized by either Party (whether acting individually or collectively under the JSC), then the foregoing royalty on net sales shall be converted to a [**] percent ([**]%) royalty on net profits of Ficlatuzumab for the balance of the royalty term then remaining in such country. “Follow-On Biologic Competition” shall mean, with respect to a given country, the commercial availability of a Third Party product that: (x) contains an Antibody having an identical or substantially identical amino acid sequence to Ficlatuzumab; and (y) has received regulatory approval for use in such country through any current or future regulatory approval process by which the sponsor or the regulatory agency relies, in whole or in part, directly or indirectly, upon the data supporting Ficlatuzumab.
All license fees, royalties and milestone payments owed to Third Parties, including pursuant to the AVEO Third Party Agreements, shall serve to reduce the net sales figure to which the Opt-Out Royalty is applied. In the event that AVEO is the Opt-Out Party, Biodesix shall assume all obligations to pay such license fees, royalties and milestone payments owed to Third Parties, including pursuant to the AVEO Third Party Agreements, based on Biodesix’s Development, manufacture and Commercialization of Ficlatuzumab following such Opt-Out. |
In the event that AVEO is the Opt-Out Party, AVEO agrees to provide Ficlatuzumab and provide a manufacturing tech transfer pursuant to Section 3.6(b)(viii) of the Co-Development Agreement.
The Opt-Out Royalty would be payable, if Biodesix is the Opt-Out Party, for so long as Ficlatuzumab is marketed by the non-Opt-Out Party or its successors or assigns in any jurisdiction in the Territory and, if AVEO is the Opt-Out Party, for so long as, on a country-by-country basis, any patent or patent application within the AVEO Patent Rights, Biodesix Patent Rights or Joint Patent Rights or any applicable regulatory exclusivity covers the manufacture, use, offer for sale, sale or importation of Ficlatuzumab in the applicable country.
Following an Opt-Out by Biodesix, the obligations of Biodesix under “VeriStrat Commercialization” above shall continue.
The parties recognize that in order to give effect to the foregoing Opt-Out rights, the parties will need to include customary licensing terms in the Commercialization Agreement. In addition, if an Opt-Out occurs prior to the negotiation of the Commercialization Agreement, the parties recognize that the Commercialization Agreement would be negotiated to include such licensing terms, but would not include the profit and loss sharing and other terms that become inapplicable due to such Opt-Out. | ||||
Joint Commercialization Committee during the Profit-Sharing Phase | • | Oversees commercialization efforts, including development of commercialization plans and budgets for the JSC’s approval. | ||
• |
Reports to JSC, with disputes escalated for resolution by the JSC as described in the Co-Development Agreement. | |||
• |
Would not (nor would the JSC) have oversight of commercialization after an Opt-Out. | |||
Diligence during the Profit-Sharing Phase | The Commercialization Agreement will include an obligation for the parties to use Commercially Reasonable Efforts to commercialize Ficlatuzumab and to perform their obligations pursuant to the agreed commercialization plans and budgets. |
EXHIBIT C
PRESS RELEASE
AVEO and Biodesix Partner to Co-Develop and Commercialize
Ficlatuzumab with a Companion Diagnostic for Treatment of NSCLC
Biodesix to Fund Proof of Concept Study
CAMBRIDGE, Mass. and BOULDER, Colo. — April 10, 2014 — AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. today announced that they have entered into a worldwide agreement to develop and commercialize AVEO’s hepatocyte growth factor (HGF) inhibitory antibody ficlatuzumab, with a Biodesix® companion diagnostic test. This agreement and the clinical development program will leverage VeriStrat®, a serum protein test that is commercially available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer (NSCLC). VeriStrat will be used as the selection assay to identify NSCLC patients most likely to benefit from ficlatuzumab.
An exploratory analysis from AVEO’s Phase 2 study in first-line NSCLC suggested that VeriStrat was prognostic for outcome in the epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitor (TKI)-treated patients and predicted differential treatment benefit for the combination of ficlatuzumab plus TKI over TKI alone. The predictive effect was observed in both progression-free survival and overall survival endpoints.
Under the terms of the agreement, AVEO will conduct a proof of concept study of ficlatuzumab in combination with erlotinib in advanced NSCLC patients selected using the VeriStrat test. Biodesix will fund up to $15 million of the cost of the study. The companies expect to initiate this clinical study later this year. Any additional development, regulatory and commercial costs for ficlatuzumab beyond the proof of concept study will be shared equally as will any potential profits. Subject to regulatory approval, AVEO will lead worldwide commercialization of ficlatuzumab. Biodesix will be responsible for all development, including FDA engagement activities, sales and marketing costs for VeriStrat, and will retain total revenues for sales of VeriStrat.
“We are pleased to initiate this collaboration with AVEO,” said Xxxxx Xxxxxx, chief executive officer of Biodesix. “Ficlatuzumab is targeting an oncogenic pathway that we believe may be important in certain patient subsets. By leveraging our multiplexed platform and advanced analytics, we hope to identify those patients who gain substantial benefit from ficlatuzumab. We believe our initial work with AVEO is very encouraging.”
“This agreement accomplishes a key strategic objective of advancing our pipeline assets through external collaborations and funding,” stated Xxxx Xx-Xxxx, president and chief executive officer of AVEO. “The exploratory analysis suggests that Biodesix’ novel diagnostic test may help define patient populations that can benefit from treatment with ficlatuzumab. We believe this type of innovative partnership between a therapeutic and a molecular diagnostic company is important to advancing personalized medicine.”
About Ficlatuzumab
Ficlatuzumab is a humanized IgG1K antibody that binds to the HGF ligand with high affinity and specificity to inhibit the biological activities of the HGF/c-Met pathway. Studies have demonstrated that ficlatuzumab is well tolerated as a single agent as well as in combination with EGFR TKIs.
About the HGF/c-Met Pathway
HGF is the sole ligand that binds to and activates a receptor called c-Met. Activation of the HGF/c-Met pathway is believed to be important in normal processes in embryonic development and wound healing, but its dysregulation is believed to play a role in cancer development, metastasis and drug resistance. HGF/c-Met has also been shown to be one of the most potent drivers of tumor growth in AVEO’s Human Response Platform™.
HGF/c-Met over-expression is observed in many solid tumors including breast, colorectal, gastric, head and neck, lung and prostate, as well as hematologic malignancies. Additionally, c-Met and EGFR are frequently co-amplified and co-expressed in a variety of tumor types; HGF/c-Met pathway up-regulation can render resistance to EGFR-targeted therapies, and vice-versa. HGF has also been shown to be one of the most potent growth factors that can drive resistance to a panel of anti-cancer therapies.
About VeriStrat
VeriStrat is a multivariate, blood-based, protein test currently available to help physicians guide treatment decisions for patients with advanced non-small cell lung cancer. The test identifies patients who are likely to have good or poor outcomes after treatment with either epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) therapy such as erlotinib or with chemotherapy. VeriStrat is based on Biodesix’ proprietary proteomics platform which enables the discovery of multivariate classifiers that characterize a patient’s condition or likely outcome in response to therapy. xxx.XxxxXxxxxXxxxxxx.xxx
About AVEO
section titled “Risk Factors” included in AVEO’s most recent Annual Report on Form 10-K and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release.
AVEO Contacts
AVEO Investor Relations:
(000) 000-0000
Media: Xxx Xxxxxxx, Pure Communications
(000) 000-0000
Biodesix Contacts
Xxxx Xxxxxx or Xxxxx Xxxxxxx
(000) 000-0000
Xxxxxxxx@Xxxxxxxxxxxx.xxx
EXHIBIT D
AVEO THIRD PARTY AGREEMENTS
[**]
EXHIBIT E
INITIAL VERISTRAT DEVELOPMENT PLAN
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. [**]
Schedule 8.1(c)
Sections 3.1, 3.3, 3.4, 4.7, 4.8, 6.2, 12.1, and 12.2 of the [**] Agreement and Articles 5, 8 and 10 of the [**] Agreement.
Section 3.18 of the [**] Agreement.
Schedule 11.1(k)
(a) | [**] Agreement. Sections 4.2, 4.3, 4.4, 6.1, and 6.2 of the [**] Agreement set forth payment obligations related to the Development or Commercialization of Ficlatuzumab. Section 9.1.2 of the [**] Agreements sets forth indemnification obligations owed to [**]. |
(b) | [**] Agreement. Pursuant to and as set forth in Section 3.18 of the [**] Agreement and the Project Plan (as defined in the [**] Agreement), AVEO shall pay [**] certain fees in the event AVEO utilizes the [**] to [**] Ficlatuzumab. Currently, AVEO does not utilize the [**] to [**] Ficlatuzumab. Section 5 requires AVEO to pay for [**] according to the pricing stipulated in the Project Plan. Section 3.19 of the [**] Agreement contemplates payments to [**] in relation to performance of a technology transfer. Section 3.20 of the [**] Agreement sets forth payment obligations to [**] in the event of a cancellation or postponement of [**]. Section 6.1 of the [**] Agreement sets forth certain payment obligations in the event of a recall of Ficlatuzumab. Section 6.5 of the [**] Agreement sets forth indemnification obligations owed to [**]. Section 7.2 of the [**] Agreement sets forth amounts owed to [**] in connection with the provision of assistance and information in connection with regulatory filings. |
(c) | [**] Agreement. Pursuant to the Sections 3 and 4 of the [**] Agreement, in the event that AVEO utilizes [**] to [**] Ficlatuzumab, AVEO shall pay [**] the payments as set forth in Section 4 of the [**] Agreement. Section 14 of the [**] Agreement sets forth indemnification obligations owed to [**]. |