arvinasfmicdxagreementre






Exhibit 10.1        CERTAIN INFORMATION IN THIS DOCUMENT, MARKED BY  [**] HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT  IS BOTH (I) NOT MATERIAL AND (II) WOULD LIKELY BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.      MASTER IN VITRO DIAGNOSTICS AGREEMENT  between  FOUNDATION MEDICINE, INC.,  ARVINAS OPERATIONS, INC.  and, solely for purposes of Section 11.19 hereof,  ARVINAS, INC.   Dated as of  June 4, 2022    





 






  Master In Vitro Diagnostics Agreement 1 of [33] CONFIDENTIAL    MASTER IN VITRO DIAGNOSTICS AGREEMENT  This Master In Vitro Diagnostics Agreement (this “Agreement”) is effective as of June 4, 2022 (the  “Effective Date”) by and between Foundation Medicine, Inc., a Delaware corporation with its principal  place of business at 150 Second Street, Cambridge, Massachusetts 02141, United States (“FMI”),  Arvinas Operations, Inc., a Delaware corporation with its principal place of business at 5 Science Park,  395 Winchester Avenue, New Haven, CT 06511 (“Company”) and, solely for purposes of Section 11.19  hereof, Arvinas, Inc., a Delaware corporation with its principal place of business at 5 Science Park, 395  Winchester Avenue, New Haven, CT 06511 (“Company Parent”).  FMI and Company are sometimes  referred to herein individually as a “Party” and collectively as the “Parties.”  RECITALS  WHEREAS, the Parties desire to collaborate to enable FMI to seek and obtain  Regulatory Approval for one or more FMI Assays for use with one or more Company Products, in each  case, as set forth in a Statement of Work (SOW) (each capitalized term as defined below) executed by  each Party under this Agreement and according to the following terms and conditions; and  [**].  NOW, THEREFORE, in consideration of the premises and the mutual promises and  conditions set forth herein and other good and valuable consideration, the receipt and sufficiency of which  are hereby acknowledged, the Parties, intending to be legally bound, do hereby agree as follows:  ARTICLE 1  DEFINITIONS  Unless otherwise specifically provided herein, the following terms shall have the  following meanings:  1.1. “Activities” means the activities to be performed by a Party under an applicable  SOW.   1.2. “Affiliate” means any Person that (i) directly or indirectly controls a Party, (ii) is  directly or indirectly controlled by a Party, or (iii) is controlled, directly or indirectly, by the ultimate  parent company of a Party.  For purposes of this definition, “control” and, with correlative meaning, the  term “controlled by” means the ownership, directly or indirectly, of more than fifty percent (50%) of the  voting securities or other ownership interest of an organization or otherwise having the power to govern  the financial and operating policies or to appoint the management of an organization.  Notwithstanding  the foregoing, for purposes of this Agreement, Roche Holding Ltd, of Basel, Switzerland and Chugai  Pharmaceutical Co., Ltd., of Tokyo, Japan, and their respective direct or indirect subsidiaries (including in  the case of Roche Holding Ltd, Genentech, Inc., Roche Diagnostics Corporation, Roche Molecular  Systems, Inc. and their respective direct and indirect subsidiaries), other than direct or indirect  subsidiaries of FMI, shall not be Affiliates of FMI (and thus shall constitute Third Parties for purposes of  this Agreement).   1.3. [**].    1.4. “Analytical Validation Samples” means any Samples provided by Company or  any of its Affiliates [**]  For clarity, an Analytical Validation Sample may also be a Clinical  Development Sample or Trial Enrollment Sample.   





 






  Master In Vitro Diagnostics Agreement 2 of [33] CONFIDENTIAL    1.5. “Analytical Validation Studies” means any and all studies directed to  establishing the accuracy, reliability, reproducibility, sensitivity, specificity, or other performance of any  [**].  1.6. “Applicable Law” means applicable laws, rules and regulations, including any  rules, regulations, guidance or other requirements of a Regulatory Authority, that may be in effect from  time to time and applicable to a particular activity hereunder, and shall be deemed to include the  applicable regulations and guidances of the FDA that constitute [**] (and, if and as appropriate under the  circumstances, International Conference on Harmonization (ICH) guidance).    1.7. “Approved IVD” means, with respect to an IVD and country or territory, that  such IVD has been granted Regulatory Approval for such country or territory for the intended use,  including, for example, any required PMA Approval.  The term “Approved IVD” is not intended, and  shall not be construed, to include any IVD solely for research or investigational purposes.  1.8. “Assay Submission Package” means [**].  1.9. “CE Marking Approval” means completion of all conformity assessment  procedures required under the IVD Directive or IVD Regulation, as applicable, including obtaining any  necessary certifications by a Notified Body of the conformity of an in vitro diagnostic medical device  with the requirements of the IVD Directive or IVD Regulation, as applicable, and applicable harmonized  standards necessary for the manufacturer of such device to affix a CE mark and place such device on the  market in the EU.   1.10. “Change of Control” means a transaction occurring after the Effective Date in  which a Party or any parent company of such Party: (i) sells, conveys or otherwise disposes of all or  substantially all of its property or business to which this Agreement relates; or (ii)(a) merges or  consolidates with any other Person (other than a wholly-owned subsidiary of such Party or such parent  company) or (b) effects any other transaction or series of transactions; in each case ((a) or (b)), such that  the stockholders of such Party or such parent company immediately prior thereto, in the aggregate, no  longer own, directly or indirectly, beneficially or legally, at least fifty percent (50%) of the outstanding  voting securities or capital stock of the surviving Person following the closing of such merger,  consolidation, other transaction or series of transactions.    1.11. “CLIA” means the Clinical Laboratory Improvement Amendments of 1988, their  implementing regulations and guidance or any corresponding or similar foreign laws, regulations or  guidance.  1.12. “Clinical Development Samples” means Samples obtained by or on behalf of  Company or any of its Affiliates from subjects enrolled in Clinical Studies of any Company Product and  provided to FMI for use in connection with the Activities.  [**].  1.13. “Clinical Outcomes Data” means clinical data [**]generated in the conduct of  Clinical Studies conducted by or on behalf of Company or any of its Affiliates with respect to a Company  Product that are related to the safety or efficacy of such Company Product.    1.14. “Clinical Studies” means studies conducted in human subjects and required by  Applicable Law or recommended by a Regulatory Authority to obtain or maintain Regulatory Approvals  for a Therapeutic Product.  1.15. “Collaboration Data” means that portion of the [**].  





 






  Master In Vitro Diagnostics Agreement 3 of [33] CONFIDENTIAL    1.16. “Collaboration IP” means [**].  1.17. “Collaboration Know-How” means Know-How that is conceived, generated or  otherwise developed [**].  1.18. “Commercialization” means any and all activities directed to the preparation for  sale of, offering for sale of, or sale of a product, including activities related to marketing, promoting,  distributing and importing such product, and interacting with Regulatory Authorities regarding any of the  foregoing.  For clarity, when used in relation to an FMI Assay or other IVD, “Commercialization”  includes activities directed to the preparation for the sale of, offering for sale of, or sale of a service using  such FMI Assay or other IVD, including activities related to marketing and promoting such service, and  interacting with Regulatory Authorities regarding any of the foregoing.  When used as a verb, “to  Commercialize” and “Commercializing” mean to engage in Commercialization, and  “Commercialized” has a corresponding meaning.  1.19. “Commercially Reasonable Efforts” means such efforts that are consistent with  the efforts and resources normally associated with good business practice and standards [**].  1.20. “Companion Diagnostic” means an Approved IVD that provides information  essential to the safe and effective use of a corresponding Therapeutic Product or is otherwise necessary  for the Regulatory Approval of a Therapeutic Product.  1.21. “Company Background IP” means [**].  1.22. “Company Product” means a Therapeutic Product identified in an SOW for  Development or Commercialization with an FMI Assay identified in such SOW.  1.23. “Complementary Diagnostic” means an Approved IVD that provides  information helpful to the safe and effective use of a corresponding Therapeutic Product, but that is not a  Companion Diagnostic.  1.24. “Control” means, with respect to any (i) (a) Know-How, (b) Patent or (c) other  intellectual property right; (ii) Regulatory Documentation; or (iii) material, possession of the right,  whether directly or indirectly and whether by ownership, license or otherwise (other than by operation of  the licenses and other grants in Sections 6.2 and 6.3), to grant a license, sublicense or other right  (including the right to reference Regulatory Documentation) to or under such Know-How, Patent, other  intellectual property right, Regulatory Documentation or material as provided for herein without violating  the terms of any agreement with any Third Party.  1.25. “Deliverables” means the work product or other deliverables a Party agrees to  provide to the other Party with respect to a project, as specified in the applicable SOW.  1.26. “Development” means activities relating to the development, optimization,  validation or clinical testing of any product (including any Product), including activities relating to  obtaining or maintaining Regulatory Approval of such product.  When used as a verb, “Develop” means  to engage in Development.  1.27. “Disclosing Party” means, with respect to Confidential Information, the Party  that provides or is deemed to provide such Confidential Information to the other Party.  1.28. “Drug Approval Application” means a “new drug application” as defined in the  FFDCA, a “biologics license application” as defined in the FFDCA, or any corresponding foreign  





 






  Master In Vitro Diagnostics Agreement 4 of [33] CONFIDENTIAL    application in any country or territory, including, with respect to the EU, a marketing authorization  application filed with the EMA pursuant to the centralized approval procedure or with the applicable  Regulatory Authority of a country in the EU with respect to the mutual recognition procedure or any other  national approval, and any supplement to any of the foregoing.  1.29. “EMA” means the European Medicines Agency and any successor agency  thereto.  1.30. “European Union” or “EU” means that certain economic, scientific and political  organization of member states known as the European Union, as it may be constituted from time to time,  or any successor thereto.  1.31. “Exploit” means to make, have made, import, use, sell, offer for sale or  otherwise exploit, including to research, Develop, Commercialize, register, manufacture, have  manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute,  promote, market or have sold or otherwise dispose of.  For clarity, when used in relation to any IVD,  “Exploit” includes the performance of any service using such IVD, and the making, having made, import,  use, sale or offer for sale or other exploitation of such IVD for use in connection with such service,  including the research, Development, Commercialization, registration, manufacture, having  manufactured, holding or keeping (whether for disposal or otherwise), having used, exportation,  transportation, distribution, promotion, marketing or having sold or otherwise disposing of such IVD for  use in connection with such service.  “Exploitation” means the act of Exploiting.     1.32. “FDA” means the United States Food and Drug Administration and any  successor agency thereto.  1.33. “FFDCA” means the United States Federal Food, Drug, and Cosmetic Act, as  amended from time to time, together with any rules, regulations and requirements promulgated thereunder  (including all additions, supplements, extensions and modifications thereto).  1.34. “FMI Assay” means [**].    1.35. “FMI Contracting Collaborator” means a Third Party with which FMI or any  of its Affiliates has entered or enters into a contractual arrangement pursuant to which such Third Party  collaborates with FMI in relation to, or is granted rights to Exploit, the FMI Technology Platform (or  aspects thereof) or any IVD in countries or territories outside the United States.   1.36. “FMI Operational Documentation” means documents and information setting  forth or associated with the internal practices, policies, procedures, and systems used by or on behalf of  FMI or any of its Affiliates to conduct and [**] including all documents and information related to  compliance with QSR and CLIA requirements in the United States and any corresponding or similar  requirements under Applicable Law for any other country or territory.  1.37. “FMI Technology Platform” means FMI products or services for testing of  specimens to identify [**] and related technologies and any improvements to any of the foregoing, in  each case, existing as of the Effective Date or during the Term.     1.38. [**].   1.39. “IND” means (i) an investigational new drug application filed with the FDA for  authorization to commence Clinical Studies or any corresponding or similar application in other countries  





 






  Master In Vitro Diagnostics Agreement 5 of [33] CONFIDENTIAL    or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the  foregoing.  1.40. “Indication” means, as specified in an applicable SOW, a disease or condition  that a Company Product may be used to treat or prevent, subject to Regulatory Approval.  1.41. “IVD” or “In Vitro Diagnostic” means a product or service for in vitro testing of  patient or subject specimens, or other biological materials, for use in the diagnosis or evaluation of a  disease, including to identify any genomic alterations or signatures, or for the prediction or monitoring of  a response to any Therapeutic Product (or other agent) or other prognostic use, whether used for research,  exploratory purposes, or as a clinical diagnostic.  The term “IVDs” includes “Investigation Use Only”  products, “Research Use Only” products, Companion Diagnostics, Complementary Diagnostics and other  IVDs.  1.42. “IVD Directive” means Directive 98/79/EC of the European Parliament and of  the Council of 27 October 1998 on in vitro diagnostic medical devices, as amended from time to time, and  as implemented in the EU member states under national law, or any statutory modification, extension or  re-enactment thereof.  1.43. “IVD Regulation” means Regulation (EU) 2017/746 of the European Parliament  and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive  98/79/EC and Commission Decision 210/227/EU.  1.44. “Know-How” means all tangible and intangible: information, techniques,  technology, practices, trade secrets, inventions (whether patentable or not), methods, know-how, data  (including [**]), results (including [**]), analytical and quality control data, descriptions, software and  algorithms, in each case, of a scientific or technical nature, excluding [**] Documentation and [**]  Documentation.  1.45. “Market” means, on a Company Product-by-Company Product and Indication- by-Indication basis, as specified in an applicable SOW, a country or territory for which the Parties intend  to Develop and seek Regulatory Approval of an FMI Assay for use with such Company Product for such  Indication to enable the Commercialization of such FMI Assay in such country or territory.   1.46. “Materials” means Samples or other biological materials, compounds, reagents  and supplies that Company delivers or causes to be delivered to FMI in connection with an SOW.   1.47. “Notified Body” means an entity licensed, authorized or approved by the  applicable government agency, department or other authority to assess and certify the conformity of an in  vitro diagnostic medical device with the requirements of the IVD Directive or IVD Regulation, as  applicable, and applicable harmonized standards.  1.48. “Patents” means: (i) all national, regional and international patents and patent  applications, including provisional patent applications; (ii) all patent applications claiming priority from  such patent applications, provisional applications or from an application claiming priority from either of  these, including divisionals, continuations, continuations-in-part, converted provisionals and continued  prosecution applications; (iii) any and all patents that have issued or in the future issue from the foregoing  patent applications ((i) and (ii)), including utility models, petty patents, innovation patents and design  patents and certificates of invention; (iv) any and all extensions or restorations by existing or future  extension or restoration mechanisms, including revalidations, reissues, re-examinations, reviews and  extensions (including any supplementary protection certificates and the like) of the foregoing patents or  patent applications ((i), (ii) and (iii)); and (v) any similar rights, including so-called pipeline protection or  





 






  Master In Vitro Diagnostics Agreement 6 of [33] CONFIDENTIAL    any importation, revalidation, confirmation or introduction patent or registration patent or patent of  additions to any of such foregoing patent applications and patents.  1.49. “Permitted Representative” means a representative duly authorized by  Company who shall be bound by written confidentiality and non-use obligations no less stringent than  those set forth in this Agreement, and shall explicitly exclude any direct competitors of FMI   1.50. “Person” means an individual, sole proprietorship, partnership, limited  partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock  company, trust, unincorporated association, joint venture or other similar entity or organization, including  a government or political subdivision, department or agency of a government.  1.51. “PMA” means (i) a premarket approval application filed with the FDA or any  corresponding or similar application in other countries or regulatory jurisdictions and (ii) all supplements  and amendments that may be filed with respect to the foregoing.  1.52. “PMA Approval” means approval in accordance with Section 515 of the  FFDCA and 21 C.F.R. Part 814 of a PMA, including approval of supplemental PMAs (including those  supplemental PMAs reviewed using the ‘Real-Time Review’ process), by the FDA for a Class III device  or similar approval in other countries or regulatory jurisdictions.  1.53. “Product” means, in the case of Company, any Company Product and, in the  case of FMI, any FMI Assay, in each case, as designated in an applicable SOW.  1.54. “Program,” as such term is used in relation to partial termination of this  Agreement, or to any consequences of any such partial termination, means, collectively, an applicable  FMI Assay, Company Product, Indication and Market covered by an SOW.  For clarity, an SOW may  cover [**].   1.55. “Quality System Regulation” or “QSR” means the requirements applicable to  manufacturers of finished medical devices (including design control and current good manufacturing  practices) pertaining to the methods used in, and the facilities and controls used for, the design,  manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for  human use, as specified in 21 C.F.R. Part 820 and FDA’s guidance documents, and all successor  applicable regulations and guidance documents thereto.   1.56. “Receiving Party” means, with respect to Confidential Information, the Party  that receives or is deemed to receive such Confidential Information from the other Party or its agents.  1.57. “Regulatory Approval” means any and all clearances, approvals, licenses,  registrations or authorizations of any Regulatory Authority necessary to commercially distribute, sell or  market a product (including a Company Product or an FMI Assay) in a country or territory, including, in  the case of an IVD, any required certificates of conformity from a Notified Body and the manufacturer’s  formal declaration of conformity that the IVD complies with the requirements for CE marking.  1.58. “Regulatory Authority” means any applicable supra-national, federal, national,  regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or  other government entities regulating or otherwise exercising authority with respect to the Exploitation of  Therapeutic Products or IVDs (including Products) in any country, regulatory jurisdiction or territory,  including the FDA for the United States and the EMA for the European Union, and any Notified Body  that has responsibility for the regulation of any IVD for any country, regulatory jurisdiction or territory,  and any successor(s) to any of the foregoing.  





 






  Master In Vitro Diagnostics Agreement 7 of [33] CONFIDENTIAL    1.59. “Regulatory Documentation” means: all (i) applications (including all INDs,  Drug Approval Applications, investigational device exemption filings, 510(k)s, de novo determinations,  humanitarian device exemption filings and PMAs), registrations, licenses, authorizations and approvals  (including Regulatory Approvals); and (ii) correspondence and reports submitted to or received from  Regulatory Authorities (including minutes and official contact reports relating to any communications  with any Regulatory Authority), including all adverse event files and complaint files; in each case ((i) and  (ii)), relating to an FMI Assay or a Company Product.  1.60. “Samples” means biological materials, including human tissue and its derivatives  or components (e.g., cell lines and DNA), as may be further identified in an applicable SOW, which may  include [**] Samples, as applicable.  1.61. “Selected Biomarker(s)” means the one or more biomarkers identified in an  applicable SOW as relevant to an FMI Assay and a Company Product.  1.62. “Senior Officer” means, with respect to FMI, its Vice President of Biopharma  and Corporate Alliances and with respect to Company, its Chief Scientific Officer, or their respective  designees.   1.63. “SOW” or “Statement of Work” means a plan executed by an authorized  representative of both Parties under this Agreement that details a project, in the form provided as  Attachment A.  1.64. “SOW Effective Date” means, with respect to an SOW, the date on which such  SOW becomes effective, as set forth in such SOW.  1.65. “Statistical Analysis Plan” means any statistical analysis plan used or developed  for use in performing any statistical analysis under the applicable SOW for the purpose of [**].  1.66. “Therapeutic Product” means any product that constitutes or contains a  chemical or biologic substance for the medical cure, treatment or prevention of disease.  1.67. “Third Party” means any Person other than FMI, Company and their respective  Affiliates.  1.68. [**].  1.69. “Trademark Rights” means any word, name, symbol, color, shape, designation  or any combination thereof, including any trademark, service mark, trade name, corporate name, brand  name, sub-brand name, trade dress, product configuration, program name, delivery form name,  certification mark, collective mark, logo (including corporate logo), tagline, slogan, design or business  symbol, that functions as an identifier of source or origin, whether or not registered and all statutory and  common law rights therein and all registrations and applications therefor, together with all goodwill  associated with, or symbolized by, any of the foregoing.  1.70. “Trial Enrollment Samples” means Samples obtained by or on behalf of  Company or any of its Affiliates in connection with any Clinical Study of a Company Product and  provided to FMI for testing in order to determine the eligibility of a patient for enrollment in such Clinical  Study.    1.71. “United States” or “U.S.” means the United States of America and its territories  and possessions (including the District of Columbia and Puerto Rico).  





 






  Master In Vitro Diagnostics Agreement 8 of [33] CONFIDENTIAL    1.72. Each of the following terms is defined in the Section set forth opposite such term:  Term Section  Agreement Preamble  Alliance Manager 4.3  Breaching Party 10.3.1  Breach Notice 10.3.1  Company Preamble  Company Collaboration IP 6.1.1(ii)  Company Indemnitees 9.2  Company Trademark Rights 6.2.2  Confidential Information 7.1.1  Dispute 11.5.1  Effective Date Preamble  Fee Schedule 5.1  FMI Preamble  FMI Collaboration IP 6.1.1(i)  FMI Indemnitees 9.1  FMI Trademark Rights 6.2.1  [**] [**]  Indemnitee 9.3  Indemnitor 9.3  IRB/Ethics Committee 2.4.2  Joint Collaboration IP 6.1.1(iii)  Joint Project Team or JPT 4.1  Losses 9.1  Non-Breaching Party 10.3.1  Notice Period 10.3.1  Officials 8.2.1  [**] [**]  Payment Breach 10.3.1  Payments 8.2.1  Qualified Assignee 5.3  [**] [**]  Subcontractor 11.3  Taxes 5.4  Term 10.1  Third Party Claims 9.1  [**] [**]  [**] [**]  ARTICLE 2  STATEMENTS OF WORK AND PROJECTS  





 






  Master In Vitro Diagnostics Agreement 9 of [33] CONFIDENTIAL    2.1. Statements of Work.  2.1.1. In General.  In the event the Parties agree that a project should be  conducted under this Agreement, then the Parties may negotiate, prepare and execute an SOW for such  project.  Upon execution of one or more SOWs, such SOW(s) shall be deemed to be incorporated into and  subject to the terms and conditions of this Agreement, and this Agreement (including such SOW(s)) shall  constitute the entire agreement between the Parties with respect to the subject matter of such SOW(s).  If  there is a conflict between the terms of this Agreement and the terms of an SOW, then the terms of this  Agreement shall prevail, unless such SOW specifically and expressly supersedes this Agreement on a  specific matter, in which case the terms of the SOW shall prevail, but only with respect to such SOW and  such matter.  Nothing herein shall create an express or implied obligation on the part of either Party to  enter into any other agreement or any SOW(s).  2.1.2. Additional Markets.  In the event that Company desires to  Commercialize a Company Product for an Indication in a country or territory that is not a Market with  respect to such Company Product and Indication, where the relevant Regulatory Authorities for such  country or territory require that a Companion Diagnostic for such Company Product be available in such  country or territory for any such Commercialization, Company may provide written notice to FMI of such  desire and specifying such country or territory.  Without limiting Section 2.1.1, the Parties shall discuss in  good faith whether to amend the applicable SOW or enter into a new SOW to provide for FMI to conduct  further Development of, and seek Regulatory Approval for, the applicable FMI Assay for use as a  Companion Diagnostic for such Company Product for such Indication for such country or territory, and to  provide for additional milestones or other payments to FMI in connection therewith.  Upon the Parties  entering into such amendment or new SOW, such additional country or territory will be considered a  Market under the applicable SOW.   2.2. Performance of Activities.  Each Party shall[**]to perform the Activities,  including the provision of any [**], in each case, assigned or allocated to it under an applicable SOW.   Notwithstanding the foregoing, the Parties acknowledge that each Party’s performance under each SOW  [**]  For clarity, as between the Parties, (i) Company shall, at its own expense, be responsible for the  Development of the Company Product(s), including the conduct of the Clinical Studies for the Company  Product(s)[**].    2.3. Coordination.  FMI shall keep Company reasonably informed, through the  applicable JPT, of its Development Activities for each FMI Assay Developed under an SOW for use with  a Company Product for each applicable Market and Indication.  Company shall keep FMI reasonably  informed, through the applicable JPT, of its Development activities (including any Activities) for each  Company Product for which an FMI Assay is Developed under an SOW, to the extent that such  Development activities could reasonably impact Development of such FMI Assay.   2.4. Materials.    2.4.1. In General.  Company shall provide to FMI, free of charge, the  Materials specified in each SOW.  Without limitation to the foregoing, (i) Company shall provide to FMI,  free of charge, any [**].  If FMI determines that any Materials provided by or on behalf of Company do  not conform to their descriptions under the applicable SOW or are not suitable for the Activities under the  applicable SOW, then Company shall provide new or replacement Materials.  2.4.2. Use and Disclosure.  [**].  2.4.3. Samples Requirements.  Company shall ensure that all Samples  transferred by or on behalf of Company to FMI under this Agreement will be or have been collected,  





 






  Master In Vitro Diagnostics Agreement 10 of [33] CONFIDENTIAL    stored, handled, transported, and delivered in a manner appropriate to ensure compliance with all  Applicable Law.  To the extent Applicable Law requires any informed consent or other authorization for  the collection or provision to FMI of any such Samples or any accompanying data, or for the use by or on  behalf of FMI as permitted by this Agreement and any applicable SOW of any such Samples or  accompanying data, then Company shall ensure that such informed consent or other authorization is  obtained with a scope that permits such activities.  With respect to any such Sample or accompanying  data, (i) at FMI’s reasonable request, Company shall provide to FMI (a) a copy of any protocol for any  Clinical Study pursuant to which such Sample or data was obtained and the institutional review board or  other ethics committee (“IRB/Ethics Committee”) approval thereof, (b) a copy of any other necessary  IRB/Ethics Committee approvals, (c) any applicable form of informed consent or other authorization and  (d) a written attestation that all necessary approvals, informed consents or other authorizations have been  obtained, and (ii) to the extent any amendment to any such protocol or form of informed consent or other  authorization would impact the use of any FMI Assay in connection with a Clinical Study pursuant to any  SOW, Company shall promptly inform FMI in writing of such amendment and provide to FMI any  applicable updated versions of the items described in clauses (i)(a)-(d) above.  FMI shall handle, store,  use and, as applicable, transport the Samples provided to it by or on behalf of Company in a manner  consistent with all Applicable Law.  Company shall not, without first obtaining FMI’s prior written  consent and appropriate informed consent, if applicable, deliver to FMI personally identifiable healthcare  information or other data that could potentially identify a specific individual, in connection with the  Samples or otherwise.  Upon Company’s prompt written request following the end of the term of an  SOW, FMI shall, at Company’s sole expense, return to Company any unused Samples associated with  such SOW that were provided to FMI by or on behalf of Company.   2.5. Regulatory Approval of FMI Assays, Company Products and Rights of  Reference.  2.5.1. FMI Assays.    (i) FMI shall, at its own expense, have the sole right to prepare,  obtain and maintain Regulatory Approvals for, and to conduct communications with the Regulatory  Authorities regarding Regulatory Approvals for, any FMI Assay.  As between the Parties, all Regulatory  Documentation (including all Regulatory Approvals) generated by FMI or any of its Affiliates with  respect to any FMI Assay anywhere in the world and all FMI Operational Documentation shall be owned  by, and shall be the sole property and held in the name of, FMI or its designee.  At FMI’s reasonable  request, Company shall provide FMI with any Regulatory Documentation and other information  (including Collaboration Data) in the Control and possession of Company or any of its Affiliates with  respect to each Company Product as may be necessary for, or reasonably requested by, FMI or any of its  Affiliates to obtain or maintain Regulatory Approvals for any FMI Assay Developed under this  Agreement.  Without limiting the foregoing:   (a) if FMI determines that [**] then, at FMI’s request,  Company shall, at its option, either [**] and   (b) in the event that a Regulatory Authority requires post- PMA Approval or post-CE Marking Approval activities that are not Activities set forth in a development  plan included in an applicable SOW as a condition of obtaining or maintaining PMA Approval or CE  Marking Approval (as applicable) for use of any FMI Assay Developed pursuant to such SOW(s) with  any Company Product for a Market and Indication, then [**].    (ii) FMI shall provide Company with an opportunity to review and  comment on all regulatory filings that are [**] for use with the applicable Company Product for the  applicable Indication, in each case, to the extent any such filing involves [**] such Company Product [**]   





 






  Master In Vitro Diagnostics Agreement 11 of [33] CONFIDENTIAL    FMI shall [**] consider in good faith Company’s comments with respect thereto to the extent relating to  such Company Product; provided that in no event shall FMI be obligated to delay the submission of any  such regulatory filing due to Company’s failure to provide its comments in a timely manner.  To the  extent legally permissible, FMI shall provide Company with an opportunity to attend any scheduled  meeting with a Regulatory Authority for the applicable Market(s) regarding obtaining Regulatory  Approval of the applicable FMI Assay for use as an Approved IVD with the applicable Company Product  for the applicable Indication solely to the extent such meeting includes (or is reasonably anticipated to  include) a material discussion of such Company Product.  At FMI’s reasonable request, Company shall  participate in any such scheduled meeting.  Notwithstanding anything contained in this Section 2.5 or any  term or condition of this Agreement to the contrary, Company acknowledges and agrees that FMI shall  have no obligation to provide or disclose to Company any documents or other materials (including  Regulatory Documentation or other information) with respect to [**].  2.5.2. Company Products.  (i) Company shall, at its own expense, have the sole right to  prepare, obtain and maintain Regulatory Approvals for, and to conduct communications with Regulatory  Authorities regarding Regulatory Approvals for, any Company Product.  As between the Parties, all  Regulatory Documentation (including all Regulatory Approvals) generated by Company or any of its  Affiliates with respect to any Company Product anywhere in the world shall be owned by, and shall be  the sole property and held in the name of, Company or its designee.  At Company’s reasonable request,  FMI shall provide Company with any Regulatory Documentation and other information in the Control  and possession of FMI or any of its Affiliates with respect to each FMI Assay Developed pursuant to this  Agreement (including Collaboration Data) as may be necessary for, or reasonably requested by, Company  or any of its Affiliates to refer to such FMI Assay in obtaining or maintaining Regulatory Approvals for  any Company Product for each applicable Indication.  (ii) Company shall provide FMI with an opportunity to review and  comment on all regulatory filings that are required to be made to obtain Regulatory Approval of the  applicable Company Product for the applicable Indication(s) and applicable Market(s) for use with the  applicable FMI Assay, in each case, to the extent any such filing involves a material discussion of such  FMI Assay and which discussion has not been the subject of a prior opportunity for review and comment  by FMI.  Company shall consider in good faith FMI’s comments with respect thereto to the extent  relating to such FMI Assay; provided that in no event shall Company be obligated to delay the  submission of any such regulatory filing due to FMI’s failure to provide its comments in a timely manner.   To the extent legally permissible, Company shall provide FMI with an opportunity to attend any  scheduled meeting with a Regulatory Authority for the applicable Market(s) regarding obtaining  Regulatory Approval of the applicable Company Product for the applicable Indication solely to the extent  such meeting includes (or is reasonably anticipated to include) a material discussion of an applicable FMI  Assay.  At Company’s reasonable request, FMI shall participate in any such scheduled meeting.    2.5.3. Rights of Reference.    (i) Company shall, and shall ensure that its Affiliates shall, upon  request provide FMI (and FMI’s designated Affiliates, (sub)licensees and subcontractors) with any  appropriate letters or other similar documentation necessary to authorize such Person to cross-reference  and rely (on a non-exclusive basis) upon the contents of Company’s or any of its Affiliate’s (or, to the  extent Controlled by Company or any of its Affiliates, any of their respective (sub)licensee’s) Regulatory  Documentation for any Company Product [**].  (ii) FMI shall, and shall ensure that its Affiliates shall, upon request  provide Company (and Company’s designated Affiliates and (sub)licensees) with any appropriate letters  





 






  Master In Vitro Diagnostics Agreement 12 of [33] CONFIDENTIAL    or other similar documentation necessary to authorize such Person to cross-reference and rely (on a non- exclusive basis) upon the contents of FMI’s or any of its Affiliate’s (or, to the extent Controlled by FMI  or any of its Affiliates, any of their respective (sub)licensee’s) Regulatory Documentation for any FMI  Assay Developed [**] pursuant to this Agreement [**].  2.6. Compliance; Audits.    2.6.1. Compliance.  Each of FMI and Company shall, and shall cause its  Affiliates, and shall require its (sub)licensees and Subcontractors, to comply in all material respects with  all Applicable Law with respect to its Development activities under this Agreement.    2.6.2. Audits.  During the Term and no more than [**], on not less than [**]  days’ prior written notice and during FMI’s normal business hours, Company shall have the right to audit  or have audited by a Permitted Representative, solely to the extent necessary to confirm FMI’s  compliance with CLIA, QSR and other Applicable Law with respect to the conduct of the Activities, [**]   Notwithstanding anything to the contrary in this Section 2.6.2:   (a) any audit conducted by or on behalf of Company [**]  shall be deemed an audit under this Section 2.6.2[**] any audit conducted by or on behalf of Company  under this Section 2.6.2 shall be deemed an audit[**]provided, however, that if Company [**] notifies  FMI of any such audit [**]; and   (b) if any Regulatory Authority wishes to conduct an  inspection on one or more days reserved for Company to conduct, or have conducted, any audit pursuant  to this Section 2.6.2, then FMI shall have the right, upon written or telephonic notice to Company and  without liability, to cancel such audit and shall work with Company in good faith to reschedule such audit  for one or more days that does not conflict with such inspection.   2.6.3. Permitted Representatives.  To the extent Company elects to utilize the  services of a Permitted Representative to perform an audit permitted by Section 2.6.2, the selection of  such Permitted Representative shall be approved by FMI.  Any auditor (including any Permitted  Representative) shall be subject to FMI’s confidentiality, security and safety policies, and any audit shall  not be unreasonably disruptive to FMI’s business operations, and shall be reasonable in scope and  duration.  Any information, records or other materials provided by FMI in connection with such audit as  well as any report, summary or other documentation resulting from such audit shall constitute FMI’s  Confidential Information.    2.7. Non-Exclusive Relationship.  The Parties agree that this Agreement and any  applicable SOW, and the relationship of the Parties hereunder and thereunder, are non-exclusive,  including in the following non-limiting respects.  [**].  ARTICLE 3  COMMERCIALIZATION  3.1. Coordination on Commercialization Activities.  Unless a different time period  is specified in an applicable SOW, no later than [**] months prior to the planned final submission to the  applicable Regulatory Authority of an application for Regulatory Approval for an FMI Assay for use with  the applicable Company Product for a given Market and Indication, the applicable JPT shall commence  discussions of the high-level strategy (i) for FMI to make or cause to be made commercially available an  FMI Assay for use with the Company Product for such Market and such Indication and (ii) for Company  to make or cause to be made commercially available such Company Product for such Market and such  





 






  Master In Vitro Diagnostics Agreement 13 of [33] CONFIDENTIAL    Indication, to the extent relevant to FMI’s activities pursuant to clause (i) of this sentence.  The JPT shall  serve as a forum for the Parties to discuss periodically such strategies and to coordinate such activities as  appropriate from time to time or as the Parties may further agree.   3.2. FMI Obligations.  Following receipt of the required Regulatory Approvals for  the applicable FMI Assay for use with the applicable Company Product for the applicable Market(s) and  Indication(s), [**];  provided that such obligation is not intended and shall not be construed to require  FMI to engage in any promotion or marketing for any FMI Assay (for clarity, including any such  promotion or marketing specific to any Company Product).  3.3. Company Obligations.  Following receipt of the required Regulatory Approvals  for both (i) the applicable Company Product and (ii) the applicable FMI Assay for use with such  Company Product, in each case ((i) and (ii)), for the applicable Market(s) and Indication(s), [**].  3.4. Commercialization Terms.  As between the Parties, Company shall have the  sole right to establish the terms of sale for, and otherwise Commercialize, any Company Product and FMI  shall have the sole right to establish the terms of sale for, and otherwise Commercialize, any FMI Assay,  in each case, [**].  3.5. Statements and Compliance with Applicable Law.  Each Party shall and shall  cause its Affiliates and Subcontractors to, comply in all material respects with all Applicable Law with  respect to the Commercialization of, in the case of FMI, any FMI Assay Developed, or constituting an  Approved IVD, for use with a Company Product, and in the case of Company, any Company Product.  ARTICLE 4  COLLABORATION MANAGEMENT  4.1. Joint Project Teams.  Within [**] days after the effective date of each SOW, the  Parties shall establish a joint project team (each, a “Joint Project Team” or “JPT”) for the project under  such SOW, which shall consist of [**] representatives from each Party, each with the requisite experience  and seniority to enable such representatives to make decisions on behalf of the Party such representative  represents with respect to the issues falling within the jurisdiction of such JPT.  For clarity, a  representative of a Party may represent such Party on more than one JPT.  [**].  Each Party may  substitute one or more of its representatives to the JPT, or its designated chairperson, on written notice to  the other Party.  4.1.1. Functions of Joint Project Teams.  Each JPT shall: (i) serve as a forum  for coordinating the Parties’ efforts to carry out a project under an applicable SOW and for discussing  progress in relation to the same [**] (ii) discuss proposed amendments to the applicable SOW from time  to time (and, for clarity, any amendments shall be effective only if approved by the Parties in writing in  accordance with Section 11.8); (iii) discuss the overall strategy, including the submission plans, for  obtaining and maintaining Regulatory Approval of (a) each FMI Assay for use with the applicable  Company Product for the applicable Indication and Market and (b) each Company Product, to the extent  relating to or likely to impact any applicable FMI Assay or Regulatory Approval thereof; (iv) discuss in  good faith revised milestone events and milestone payment amounts contained in the applicable Fee  Schedule to the extent such revision is provided for pursuant to Section 5.2; and (v) conduct such other  responsibilities as may be assigned to each JPT hereunder or in accordance with this Agreement or an  applicable SOW, or as may be mutually agreed by the Parties in writing.  4.2. General Provisions Applicable to Joint Project Teams.  Each JPT shall meet  as agreed by the Parties, in person [**] or by teleconference or video conference.  The chairperson of the  





 






  Master In Vitro Diagnostics Agreement 14 of [33] CONFIDENTIAL    applicable JPT shall be responsible for calling meetings, coordinating the creation of meeting agendas,  and circulating minutes of each meeting for approval by the Parties.  A meeting of a given JPT shall  require the presence of at least [**] appointed by each Party.  Representatives of the Parties on a JPT may  attend meetings thereof either in person or by telephone, video conference or similar means in which each  participant can hear what is said by, and be heard by, the other participants.  Representation by proxy  shall be allowed.  Alliance Managers and other employees or consultants of a Party who are not  representatives of the Parties on a JPT may attend meetings of such JPT; provided that such attendees (i)  are subject to written obligations of confidentiality and non-use with respect to Confidential Information  substantially similar to the obligations of confidentiality and non-use of the applicable Party pursuant to  Article 7 (with a duration of confidentiality and non-use that is commercially reasonable under the  circumstances); and (ii) in the case of non-employees of a Party, such attendance shall be subject to the  consent of the other Party, which shall not be unreasonably withheld, conditioned or delayed.  Each Party  shall be responsible for all of its own expenses of participating in JPT meetings.     4.2.1. Decision-Making.  The Parties agree that each JPT’s role shall be  limited to coordination and providing a forum for discussion with regard to matters within the functions  of such JPT and [**] provided that this sentence is not intended, and shall not be construed, to relieve  either Party from its obligations under this Agreement.  4.2.2. Limitations on Authority.  Each Party shall retain the rights, powers,  and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be  delegated to or vested in any JPT unless such delegation or vesting of rights is expressly provided for in  this Agreement or an applicable SOW, or the Parties otherwise expressly so agree in writing.  No JPT  shall have the power to amend, modify, or waive compliance with any provision of this Agreement or any  applicable SOW.  4.3. Alliance Managers.  Each Party shall appoint [**] who shall oversee contact  between the Parties for all matters between meetings of the JPTs and shall have such other responsibilities  as the Parties may agree in writing after the Effective Date (the “Alliance Manager”).  Each Party’s  Alliance Manager may be replaced at any time on written notice to the other Party.  The Alliance  Managers shall not have decision-making authority.  For clarity, each Party’s Alliance Manager may, if  elected by such Party, also serve as a representative of such Party on one or more JPTs.  ARTICLE 5  PAYMENTS AND RECORDS  5.1. Fee Schedules for SOWs.  Each SOW shall include a schedule of fees  applicable to the project performed thereunder (each, a “Fee Schedule”), which may generally include: (i)   agreed milestone payments by Company upon the achievement of corresponding milestone events set  forth in such SOW and (ii) per Sample acquisition (as applicable) and testing fees for any genomic  profiling activities under such SOW.  5.2. Milestones.  Company shall pay to FMI the non-refundable, non-creditable  milestone payments as specified in each applicable SOW upon the achievement of the corresponding  milestone events and in accordance with the provisions of this Article 5.  Company acknowledges and  agrees that the inclusion of any milestone events with respect to any FMI Assay in an applicable SOW  shall not be construed as implying that such milestone events can or will be achieved.  In the event that  [**] then the Parties shall discuss in good faith and adopt revised milestone events and milestone payment  amounts or other fee adjustments to ensure FMI is fully compensated for the performance of  Development Activities under the applicable SOW.   





 






  Master In Vitro Diagnostics Agreement 15 of [33] CONFIDENTIAL    5.3. Covenant of Company.  Company covenants to FMI that, if Company assigns  this Agreement to a Third Party, then, unless otherwise agreed by the Parties in writing, Company shall  remain responsible for all payments hereunder; provided that if Company assigns this Agreement to a  Third Party that is a Qualified Assignee in accordance with Section 11.4.1, then Company shall no longer  be responsible for such payments as of the effective date of such assignment to the extent the obligation to  make such payments is assumed in writing by such Qualified Assignee.  “Qualified Assignee” means,  [**].  5.4. Miscellaneous.  FMI shall invoice Company (i) following achievement of the  applicable milestone event with respect to milestone payments and (ii) [**] with respect to other  payments.  Each invoice shall be submitted electronically and shall contain a statement of the milestone  event achieved or other Activities performed with respect to the applicable payments [**]  Company shall  pay each invoice within [**] days of receipt thereof.  All payments to FMI shall be remitted by deposit of  United States Dollars in the requisite amount to such bank account as FMI may from time to time  designate by notice to Company.  Neither Party shall have the right to offset any amount owed by the  other Party to such first Party under or in connection with this Agreement.  All fees set forth in this  Agreement are exclusive of sales and use taxes, including all applicable goods and services tax, value- added tax (VAT), local taxes, applicable duties, electronic delivery taxes, excise taxes, levies and import  fees (collectively, “Taxes”).  If applicable, Company shall pay any Taxes that are imposed by Applicable  Law in connection with payments by Company to FMI under this Agreement.  If any payment owed FMI  is not paid when due, then Company shall pay interest thereon (before and after any judgment) at an  annual rate (but with interest accruing on a daily basis) of [**] percent ([**]%), such interest to run from  the date on which such payment became due until payment thereof in full together with such interest.  ARTICLE 6  INTELLECTUAL PROPERTY  6.1. Collaboration IP.  6.1.1. Ownership and Use of Collaboration IP.  Subject to the license grant  in Section 6.3, as between the Parties:   (i) FMI shall own all right, title and interest in and to:  (a) [**];  (b) [**];  (c) [**]; and   (d) [**].  (ii) Company shall own all right, title and interest in and to:   (a) [**];  (b) [**];   (c) [**];   (d) [**]; and  





 






  Master In Vitro Diagnostics Agreement 16 of [33] CONFIDENTIAL    (e) [**].  (iii) The Parties shall each own an equal, undivided interest in and to:  (a) [**];   (b) [**]; and   (c) [**].  (iv) [**].  (v) Each Party shall make reasonable efforts to promptly disclose to  the other Party in writing the conception, reduction to practice, generation or other development by or on  behalf of such first Party or any of its Affiliates of any invention included in the Joint Collaboration IP.   FMI shall make reasonable efforts to promptly disclose to Company in writing the conception, reduction  to practice, generation or other development by or on behalf of FMI or any of its Affiliates of any  invention included in the Company Collaboration IP.  Company shall make reasonable efforts to promptly  disclose to FMI in writing the conception, reduction to practice, generation or other development by or on  behalf of Company or any of its Affiliates of any invention included in the FMI Collaboration IP.  Except  as expressly set forth in this Section 6.1.1(v) and as required pursuant to Section 2.5.1 neither Party shall  have the affirmative duty to disclose any Collaboration IP to the other Party.  (vi) Each Party shall, and does hereby, assign, and shall cause its  Affiliates and its and their (sub)licensees to so assign, to the other Party, without additional  compensation, such right, title and interest in and to any Know-How, improvements and other inventions,  as well as any intellectual property rights with respect thereto (including Patents), as is reasonably  necessary to fully effect ownership as provided for in this Section 6.1.1.  6.1.2. Prosecution and Maintenance of Patents Within Collaboration IP.   As between the Parties, Company shall have the sole right, but not the obligation, using counsel of its  own choice, to prepare, file, prosecute and maintain Patents within the Company Collaboration IP,  worldwide, and to be responsible for any related interference, re-issuance, re-examination, review,  opposition proceedings and patent term extensions, in each case, at its sole cost and expense.  As between  the Parties, FMI shall have the sole right, but not the obligation, using counsel of its own choice, to  prepare, file, prosecute and maintain Patents within the FMI Collaboration IP worldwide, and to be  responsible for any related interference, re-issuance, re-examination, review, opposition proceedings and  patent term extensions, in each case, at its sole cost and expense.  In the case of any Patents within the  Joint Collaboration IP, [**].  Notwithstanding the foregoing, the Parties shall cooperate and implement  reasonable Patent filing and prosecution strategies (including filing divisionals, continuations or  otherwise) so that, to the extent reasonably feasible, claims that cover the inventions constituting  Company Collaboration IP, FMI Collaboration IP and Joint Collaboration IP, are pursued in mutually  exclusive patent applications.  6.1.3. Enforcement and Defense of Collaboration IP.  As between the  Parties, Company, at its sole cost and expense and using counsel of its own choice, shall have the sole  right, but not the obligation, to prosecute infringement or misappropriation of and to defend any alleged  or threatened assertion of invalidity or unenforceability with respect to Company Collaboration IP.  As  between the Parties, FMI, at its sole cost and expense and using counsel of its own choice, shall have the  sole right, but not the obligation, to prosecute infringement or misappropriation of and to defend any  alleged or threatened assertion of invalidity or unenforceability with respect to FMI Collaboration IP.  In  the case of any Joint Collaboration IP, [**].  





 






  Master In Vitro Diagnostics Agreement 17 of [33] CONFIDENTIAL    6.2. Trademark License Grants.    6.2.1. Subject to Section 6.2.3, FMI, on behalf of itself and its Affiliates,  hereby grants to Company and its Affiliates a non-exclusive, royalty-free right and license, with the right  to grant sublicenses, to use the FMI Trademark Rights, if applicable, for use in performance of the  Activities and to refer to any FMI Assay constituting an Approved IVD for use with each Company  Product in Exploiting such Company Product, in each case, for the applicable Indication(s) and Market(s);  provided, however, that any such reference shall be limited to information included in the label for such  FMI Assay for the applicable Market.  Company agrees that any use of the FMI Trademark Rights by  Company or its Affiliates or sublicensees shall inure to the benefit of FMI.  For purposes of this  Agreement, “FMI Trademark Rights” means (i) any Trademark Rights used by or on behalf of FMI or  any of its Affiliates in connection with the Commercialization of any FMI Assay (other than the  Trademark Rights Controlled by Company and any of its Affiliates) that are Controlled by FMI or any of  its Affiliates as of the Effective Date or during the Term; and (ii) the domain names Controlled by FMI or  any of its Affiliates as of the Effective Date or during the Term, which domain names incorporate one or  more of the Trademark Rights described in clause (i) as all or part of their URL address.  6.2.2. Subject to Section 6.2.3, Company, on behalf of itself and its Affiliates,  hereby grants to FMI and its Affiliates a non-exclusive, royalty-free right and license, with the right to  grant sublicenses, to use the Company Trademark Rights, if applicable, for use in performance of the  Activities and in Exploiting any FMI Assay constituting an Approved IVD for use with each Company  Product, in each case, for the applicable Indication(s) and Market(s); provided, however, that any  reference to Company or the applicable Company Product made under such right and license shall be  limited to information included in the label for such Company Product for the applicable Market.  FMI  agrees that any use of the Company Trademarks Rights by FMI or its Affiliates or sublicensees shall inure  to the benefit of Company.  For purposes of this Agreement, “Company Trademark Rights” means (i)  any Trademark Rights used by or on behalf of Company or any of its Affiliates in connection with the  Commercialization of the Company Product(s) (other than the Trademark Rights Controlled by FMI and  any of its Affiliates) that are Controlled by Company or any of its Affiliates as of the Effective Date or  during the Term; and (ii) the domain names Controlled by Company or any of its Affiliates as of the  Effective Date or during the Term, which domain names incorporate one or more of the Trademark  Rights described in clause (i) as all or part of their URL address.  6.2.3. Each Party and its Affiliates shall, and shall require that any sublicensee  shall, [**].    6.3. [**].  6.4. Third Party Licenses.    6.4.1. FMI shall promptly notify Company in writing in the event [**].    6.4.2. With regard to any [**].  6.4.3. Except as otherwise provided in this Section 6.4, each Party shall be [**]  responsible for any other [**]fees that it or any of its Affiliates may incur in performing [**]. For clarity,  nothing in this Section 6.4 is intended to restrict Company from pursuing any [**] Therapeutic Product.  6.5. Restricted Data. Prior to providing any [**]  notwithstanding anything to the  contrary in this Agreement or any SOW, the provisions of Attachment B shall apply.   





 






  Master In Vitro Diagnostics Agreement 18 of [33] CONFIDENTIAL    6.6. Retained Rights.  Neither Party grants to the other Party under this Agreement  any intellectual property licenses or rights, express or implied, by estoppel or otherwise, other than those  licenses or rights explicitly set forth in this Agreement.  [**].  ARTICLE 7  CONFIDENTIALITY AND NON-DISCLOSURE  7.1. Confidentiality Obligations.  7.1.1. During the Term and for a period of [**] years thereafter, each Party  shall and shall cause its officers, directors, employees and agents to (i) keep confidential, in a manner  consistent with such Party’s treatment of its own confidential or proprietary information, but in no event  less than reasonable measures, (ii) not publish or otherwise disclose, directly or indirectly, except to the  extent such disclosure is expressly permitted by the terms of this Agreement or any applicable SOW, and  (iii) not use, except for the purposes of fulfilling its obligations or exercising its rights under this  Agreement, in each case ((i)-(iii)), any Confidential Information of the other Party.  “Confidential  Information” of a Party means all data, materials and information, including all Know-How and other  business, financial, legal or technical information, in any form (written, oral, photographic, electronic,  magnetic, or otherwise) provided by or on behalf of such Party or its Affiliate to the other Party or its  Affiliate in connection with this Agreement or an applicable SOW, whether prior to, on or after the  Effective Date, that is marked or otherwise identified as confidential or proprietary at the time of  disclosure or that a reasonable person would, by its nature, understand to be confidential or proprietary,  including all copies thereof.    7.1.2. Notwithstanding Section 7.1.1, (i) the terms of this Agreement and each  SOW shall be deemed the Confidential Information of both Parties (and both Parties shall be deemed to  be the Receiving Party and the Disclosing Party with respect thereto); (ii) Confidential Information  constituting Know-How included in the FMI Collaboration IP shall be deemed the Confidential  Information of FMI (and FMI shall be deemed to be the Disclosing Party and Company shall be deemed  to be the Receiving Party with respect thereto); (iii) Confidential Information constituting Know-How  included in the Company Collaboration IP shall be deemed the Confidential Information of Company  (and Company shall be deemed to be the Disclosing Party and FMI shall be deemed to be the Receiving  Party with respect thereto); and (iv) Confidential Information constituting Know-How included in the  Joint Collaboration IP shall be deemed the Confidential Information of both Parties (and both Parties shall  be deemed to be the Receiving Party and the Disclosing Party with respect thereto).   7.1.3. Notwithstanding the foregoing provisions of this Section 7.1,  Section 7.1.1 shall not apply to the Receiving Party with respect to any Confidential Information of the  Disclosing Party to the extent it can be established by the Receiving Party through competent evidence  that such Confidential Information:  (i) is or hereafter becomes publicly available through no breach of  any obligation of confidentiality by the Receiving Party; (ii) is subsequently received by the Receiving  Party from a Third Party who is not bound by any obligation of confidentiality with respect to such  information; (iii) was in the Receiving Party’s possession prior to disclosure by the Disclosing Party  without any obligation of confidentiality with respect to such information; or (iv) is independently  developed by or for the Receiving Party without reference to the Disclosing Party’s Confidential  Information; provided that the exceptions under clauses (iii) and (iv) shall not apply to the Receiving  Party with respect to Confidential Information that a Party generates but is deemed to be the Receiving  Party with respect thereto pursuant to Section 7.1.2.  Notwithstanding anything to the contrary herein, the  exceptions set forth in this Section 7.1.3 shall not apply with respect to the terms of this Agreement or any  SOW.   





 






  Master In Vitro Diagnostics Agreement 19 of [33] CONFIDENTIAL    7.2. Permitted Disclosures.  The Receiving Party may disclose Confidential  Information of the Disclosing Party to the extent that such disclosure is: (i) made in response to a valid  order of a court of competent jurisdiction or other supra-national, federal, national, regional, state,  provincial or local governmental or regulatory body of competent jurisdiction or, if in the reasonable  opinion of the Receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law,  including by the U.S. Securities Exchange Commission, or by any stock exchange upon which such  Party’s securities are listed or to which an application for listing has been submitted; provided, however,  that the Receiving Party shall first have given notice to the Disclosing Party (to the extent permitted by  Applicable Law) and given the Disclosing Party a reasonable opportunity to quash such order or to obtain  a protective order or confidential treatment requiring that the Confidential Information and documents  that are the subject of such order be held in confidence by such court or agency or, if disclosed, be used  only for the purposes for which the order was issued; (ii) subject to the Disclosing Party’s prior written  consent, not to be unreasonably withheld, conditioned or delayed, made by or on behalf of the Receiving  Party to a patent authority for purposes of obtaining or enforcing Patents included in the Collaboration IP,  in a manner not inconsistent with Section 6.1; (iii) made by or on behalf of the Receiving Party to  potential or actual investors or acquirers as may be reasonably necessary in connection with their  evaluation of such potential or actual investment or acquisition; [**] provided, however, in each case ((i)- (v)), that the Receiving Party shall take reasonable measures to assure confidential treatment of such  information, to the extent such protection is available; and provided, further, that in the that case of clause  (iii) or (v) such Persons shall be subject to obligations of confidentiality and non-use with respect to such  Confidential Information substantially similar to the obligations of confidentiality and non-use of the  Receiving Party pursuant to this Article 7 (with a duration of confidentiality and non-use that is  commercially reasonable under the circumstances).  7.3. Use of Name.  Except as expressly provided herein, including Section 6.2, in  connection with this Agreement or any Activities hereunder, neither Party shall mention or otherwise use  the name, logo or Trademark Rights of the other Party or any of its Affiliates or any of its or their  (sub)licensees (or any abbreviation or adaptation thereof) in any publication, press release, marketing and  promotional material or other form of publicity without the prior written approval of such other Party.   The restrictions imposed by this Section 7.3 shall not prohibit either Party from (i) making any disclosure  identifying the other Party to the extent required in connection with its exercise of its rights or obligations  under this Agreement or any applicable SOW or (ii) making any disclosure identifying the other Party  that is required by Applicable Law or the rules of a stock exchange on which the securities of the Party  making such disclosure are listed (or to which an application for listing has been submitted).    7.4. Public Announcements.  Neither Party shall issue any public announcement,  press release or other public disclosure regarding the terms of this Agreement or the terms of any SOW  without the other Party’s prior written consent, except for any such disclosure that is, in the opinion of the  disclosing Party’s counsel, required by Applicable Law and with respect to which reasonable prior notice  and opportunity to comment thereon is given to the other Party.    7.5. Publication.  Each Party recognizes that the publication of papers regarding  results of and other information regarding activities under this Agreement or any applicable SOW,  including oral presentations and abstracts, may be beneficial to both Parties; provided that such  publications are subject to reasonable controls to protect Confidential Information.  Accordingly, each  Party shall have the right to review and approve (not to be unreasonably delayed or withheld) any paper  proposed for publication by the other Party, including any oral presentation or abstract, which includes  Collaboration Data [**] or which otherwise includes Confidential Information of the other Party the  disclosure of which in such publication is not otherwise permitted under Section 7.1 or 7.2.   Notwithstanding the foregoing, (i) if a Party requests approval to publish or publicly present any  Confidential Information constituting Know-How included in the Joint Collaboration IP, the other Party  shall consider such request in good faith, and (ii) the publishing or presenting Party shall (a) subject to  





 






  Master In Vitro Diagnostics Agreement 20 of [33] CONFIDENTIAL    clause (i) above, comply with the other Party’s request to delete from any such paper or presentation any  Confidential Information of the other Party the disclosure of which in such publication is not otherwise  permitted under Section 7.1 or 7.2 and (b) withhold publication of any such paper or presentation for up  to [**] days after such other Party’s written request in order to permit the Parties to obtain patent  protection if either Party deems it reasonably necessary.  7.6. Return of Confidential Information.  Upon expiration or termination of this  Agreement or an applicable SOW for any reason, either Party may request in writing and the non- requesting Party shall either, with respect to Confidential Information of the other Party to which such  non-requesting Party does not retain rights under the surviving provisions of this Agreement or such  SOW: (i) promptly destroy all copies of such Confidential Information in the possession or control of the  non-requesting Party and confirm such destruction in writing to the requesting Party; or (ii) promptly  deliver to the requesting Party, at the requesting Party’s sole cost and expense, all copies of such  Confidential Information in the possession or control of the non-requesting Party.  Notwithstanding the  foregoing, the non-requesting Party shall be permitted to retain such Confidential Information (a) to the  extent reasonably necessary or useful for purposes of performing any continuing obligations or exercising  any ongoing rights hereunder or under any SOW and, in any event, a single copy of such Confidential  Information for archival purposes and (b) any computer records or files containing such Confidential  Information that have been created solely by such non-requesting Party’s automatic archiving and back- up procedures, to the extent created and retained in a manner consistent with such non-requesting Party’s  standard archiving and back-up procedures, but not for any other uses or purposes.  All Confidential  Information shall continue to be subject to the terms of this Agreement for the period set forth in  Section 7.1.1.  ARTICLE 8  REPRESENTATIONS, WARRANTIES AND COVENANT  8.1. Representations, Warranties and Covenant.    8.1.1. Mutual Representations, Warranties and Covenant.  FMI and  Company each represents and warrants to the other Party, as of the Effective Date, and, in the case of any  representation and warranty as it relates to an SOW, as of the applicable SOW Effective Date, and  covenants to the other Party that: (i) it is a corporation duly organized, validly existing and in good  standing under the laws of the jurisdiction of its organization and has all requisite power and authority,  corporate or otherwise, to execute, deliver and perform this Agreement; (ii) the execution and delivery of  this Agreement and the applicable SOW and the performance by it of the transactions contemplated  hereby have been, or in the case of an SOW, will be as of the applicable SOW Effective Date, duly  authorized by all necessary corporate action on its part; (iii) this Agreement is, and, in the case of the  applicable SOW, will be as of the applicable SOW Effective Date, a legal, valid and binding obligation of  such Party enforceable against it in accordance with the terms and conditions hereof and thereof, subject  to the effects of bankruptcy, insolvency or other laws of general application affecting the enforcement of  creditor rights, judicial principles affecting the availability of specific performance and general principles  of equity (whether enforceability is considered a proceeding at law or equity); (iv) it is not under [**] any  obligation, contractual or otherwise, to any Person that conflicts with the terms of this Agreement; and (v)  neither it nor any of its Affiliates [**] has been debarred or is subject to debarment and neither it nor any  of its Affiliates [**] will use in any capacity, in connection with the Activities to be performed under this  Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA or who is the  subject of a conviction described in such section.  Each Party covenants that it will inform the other Party  in writing promptly upon becoming aware that it or any such Person who is performing Activities  hereunder is debarred or is the subject of a conviction described in Section 306 of the FFDCA, or if any  action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of its or its  





 






  Master In Vitro Diagnostics Agreement 21 of [33] CONFIDENTIAL    Affiliates’ knowledge, is threatened, relating to the debarment or conviction of it or any such Person  performing Activities hereunder.  8.1.2. Additional Representation and Warranty and Covenant of Each  Party.  Each Party represents and warrants to the other Party, as of the Effective Date, and, as it relates to  an SOW, as of the applicable SOW Effective Date, and covenants to the other Party that, subject to  Section 11.4.2, each Party has and will at all times have all rights with respect to any [**].  8.2. Covenants of the Parties.  8.2.1. Each Party agrees that neither it, nor anyone acting on its behalf, shall,  either directly or indirectly, offer, make, or promise any payment of money or other assets in connection  with this Agreement (collectively, “Payments”) to any government or political party officials, officials of  international public organizations, candidates for public office, or persons acting on behalf of any of the  foregoing (collectively, “Officials”) where such Payments would violate Applicable Law.  8.2.2. Each Party acknowledges that no employee of the other Party or its  Affiliates shall have authority to give direction, either written or oral, relating to the making of any  commitment by such first Party or its agents to any Third Party in violation of the terms of this  Section 8.2.  8.3. DISCLAIMER OF WARRANTIES.  NEITHER PARTY MAKES ANY  REPRESENTATIONS OR GRANTS ANY WARRANTIES, EXPRESS OR IMPLIED, THAT THE  OBJECTIVES OF ANY SOW CAN OR WILL BE ACHIEVED OR AS TO THE TIMING OR COST  AND EXPENSE ASSOCIATED WITH THE ACHIEVEMENT OF ANY SUCH OBJECTIVES.   EXCEPT FOR THE EXPRESS WARRANTIES SET FORTH IN THIS AGREEMENT, NEITHER  PARTY MAKES ANY REPRESENTATIONS OR GRANTS ANY WARRANTIES HEREUNDER,  EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR  OTHERWISE AND EACH PARTY SPECIFICALLY DISCLAIMS HEREUNDER ANY OTHER  WARRANTIES, WHETHER WRITTEN OR ORAL OR EXPRESS OR IMPLIED, INCLUDING ANY  WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR  PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON- INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.  ARTICLE 9  INDEMNITY  9.1. Indemnification of FMI.  Company shall defend FMI, its Affiliates and its and  their respective [**]; except in the cases of clause (i) and clause (ii), for any Losses to the extent arising  from or occurring as a result of (a) [**].  9.2. Indemnification of Company.  FMI shall defend Company, its Affiliates, and its  and their respective [**]; except in the cases of clause (i) and clause (ii), for any Losses to the extent  arising from or occurring as a result of [**].  9.3. Indemnification Procedures.  A Party seeking indemnification (an  “Indemnitee”) shall (i) provide the indemnifying Party (“Indemnitor”) with written notice, within a  reasonable time after notice of any applicable Third Party Claim is received by Indemnitee; (ii) allow  Indemnitor to have sole control of the defense or settlement of the Third Party Claim; provided, however,  that Indemnitor shall not settle any Third Party Claim in a manner which may impose any obligation on  or have a material adverse impact on Indemnitee without the prior written consent of the Indemnitee; and  





 






  Master In Vitro Diagnostics Agreement 22 of [33] CONFIDENTIAL    (iii) provide Indemnitor with reasonable assistance, information and authority reasonably necessary to  perform Indemnitor’s obligations.  9.4. LIMITATIONS OF LIABILITY.    9.4.1. SPECIAL, INDIRECT AND OTHER LOSSES. [**].  9.4.2. GENERAL LIMITATION.  [**].  ARTICLE 10  TERM AND TERMINATION  10.1. Term. The term of this Agreement (the “Term”) commences on the Effective  Date and continues until terminated in accordance with Section 10.2, 10.3 or 10.4; provided, however,  that each SOW shall become effective as of the applicable SOW Effective Date.  10.2. Company Termination at Will. Subject to the terms and conditions of any  applicable SOW, including any termination fees provided for therein, Company may terminate this  Agreement, either in its entirety or on a SOW-by-SOW or on a Program-by-Program basis, for  convenience by providing written notice of its intent to terminate to FMI, in which case, such termination  shall be effective [**] days after FMI’s receipt of such written notice.  10.3. Termination of this Agreement in its Entirety.  10.3.1. Material Breach.  Without limiting its other rights or remedies under  this Agreement, either Party (in such capacity, the “Non-Breaching Party”) may terminate this  Agreement in its entirety (including all SOWs then in effect) immediately upon written notice to the other  Party in the event the other Party (in such capacity, the “Breaching Party”) (i) has breached any of its  material obligations under this Agreement and (ii) has failed to cure such breach within [**] days  following receipt of written notice from the Non-Breaching Party of such breach (such period of time, the  “Notice Period” and such written notice, with respect to any material breach under this Section 10.3.1 or  Section 10.4.1, a “Breach Notice”); provided that such Notice Period shall be [**] days in the event of a  failure to make any payment when due (“Payment Breach”) and provided further that, except for  Payment Breaches, the Notice Period will automatically be extended for a period of time, not to exceed  [**] days following delivery of the Breach Notice, in the event that (a) such breach cannot be cured  within the Notice Period and (b) the Breaching Party commences actions to cure such breach within the  Notice Period and thereafter diligently continues such actions.   10.3.2. Mutual Agreement.  The Parties may terminate this Agreement in its  entirety (including all SOWs then in effect) at any time by mutual written agreement.  10.3.3. Insolvency.  If either Party: (i) files for protection under bankruptcy or  insolvency laws; (ii) makes an assignment for the benefit of creditors; (iii) appoints or suffers  appointment of a receiver or trustee over substantially all of its property that is not discharged within [**]  days after such filing; (iv) proposes a written agreement of composition or extension of its debts; (v)  proposes or is a party to any dissolution or liquidation; (vi) files a petition under any bankruptcy or  insolvency act or has any such petition filed against it that is not discharged within [**] days of the filing  thereof; or (vii) admits in writing its inability generally to meet its obligations as they fall due in the  general course, then the other Party may terminate this Agreement in its entirety (including all SOWs then  in effect) effective immediately upon written notice to such Party.  





 






  Master In Vitro Diagnostics Agreement 23 of [33] CONFIDENTIAL    10.4. Termination of this Agreement with respect to a Program.  10.4.1. Material Breach.  Without limitation to Section 10.3.1, if the Breaching  Party has breached any of its material obligations under this Agreement with respect to a Program, in  addition to any other right or remedy the Non-Breaching Party may have, the Non-Breaching Party may  terminate this Agreement with respect to such Program immediately upon written notice to the Breaching  Party in the event that (i) the Non-Breaching Party has delivered a Breach Notice to the Breaching Party  and (ii) the Breaching Party has failed to cure the applicable breach within the Notice Period; provided  that such Notice Period shall be [**] days in the event of a Payment Breach; and provided further that,  except for Payment Breaches, the Notice Period will automatically be extended for a period of time, not  to exceed [**] days following delivery of the Breach Notice, in the event that (a) such breach cannot be  cured within the Notice Period and (b) the Breaching Party commences actions to cure such breach within  the Notice Period and thereafter diligently continues such actions.  10.4.2. Mutual Agreement.  The Parties may terminate this Agreement with  respect to any Program at any time by mutual written agreement.  10.4.3. Deadlock.  In the event that either Party declares a deadlock with respect  to a Program in accordance with Section 11.5.2, then either may terminate this Agreement with respect to  such Program by providing [**] days’ prior written notice to the other Party; provided that the Parties  shall continue to discuss the issues with respect to which the applicable Party declared a deadlock in good  faith during such notice period; and provided, further, that such termination shall not become effective at  the end of such notice period if FMI agrees to proceed without revisions to the milestone events,  milestone payment amounts or other fee adjustments or the Parties otherwise reach agreement on the  issue(s) with respect to which a Party declared such deadlock.  10.4.4. Inability to Obtain Regulatory Approval for an FMI Assay.  In the  event that an applicable Regulatory Authority provides written notice of its determination that such  Regulatory Authority will not grant a Regulatory Approval for an FMI Assay for use with an applicable  Company Product for an applicable Market and Indication, then, following receipt of such notice, either  Party may terminate this Agreement with respect to the applicable Program by providing [**] days’ prior  written notice to the other Party.    10.4.5. Inability to Obtain Regulatory Approval for a Company Product.  In  the event that an applicable Regulatory Authority provides written notice of its determination that such  Regulatory Authority will not grant a Regulatory Approval for a Company Product for an applicable  Market and Indication, then, following receipt of such notice, either Party may terminate this Agreement  with respect to the applicable Program by providing [**] days’ prior written notice to the other Party.     10.4.6. Inability to Secure Third Party Licenses.  [**].  10.4.7. Other Termination Rights of FMI.    (i) [**].  (ii) [**].  10.5. Rights in Bankruptcy.  All rights and licenses granted under or pursuant to this  Agreement (including any SOW) by Company or FMI are and shall otherwise be deemed to be, for  purposes of Section 365(n) of the U.S. Bankruptcy Code or any analogous provisions in any other country  or jurisdiction, licenses of rights to “intellectual property” as defined under Section 101 of the U.S.  Bankruptcy Code.  The Parties agree that the Parties, as licensees of such rights under this Agreement,  





 






  Master In Vitro Diagnostics Agreement 24 of [33] CONFIDENTIAL    shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code or any  analogous provisions in any other country or jurisdiction.  10.6. Certain Consequences of Termination.    10.6.1. Termination of Agreement in its Entirety.  If this Agreement is  terminated in its entirety pursuant to Section 10.2 or 10.3, then the following terms and conditions shall  apply (without limitation to Section 10.8), except in the event of termination by Company pursuant to  Section 10.3.1:   (i) [**];   (ii) [**];  (iii) [**];  (iv) the license granted by Company to FMI in Section 6.2.2 shall  survive in the case of any such termination occurring after Regulatory Approval of any FMI Assay for use  as an Approved IVD with a Company Product; and  (v) [**].  10.6.2. Post-Termination Payment Obligations.    (i) Payment of Amounts Due.  If this Agreement is terminated in its  entirety or with respect to any Program, or portion thereof, then Company shall (if applicable, with  respect to the terminated Program):   (a) [**];   (b) [**]  (c) [**];   (d) [**]; and  (e) [**].   The amounts due from Company to FMI pursuant to this Section 10.6.2 shall be paid within [**] days  after FMI provides Company an invoice with respect thereto (or, with respect to clauses (a) through (e)  above, by the date on which such amount is due under Section 5.4, if earlier).   (ii) Termination Fees.  Without limitation to any other amounts that  may become payable pursuant to Section 10.6.2(i), if (a) Company terminates this Agreement in its  entirety or with respect to any Program pursuant to Section 10.2 and (b) any applicable SOW provides for  payment of a termination fee in connection with such termination, then Company shall pay to FMI such  termination fee within [**] days after FMI provides Company an invoice therefor.  10.7. Remedies.  Except as otherwise expressly provided herein, termination of this  Agreement or any SOW in accordance with the provisions hereof shall not limit remedies that may  otherwise be available in law or equity.  10.8. Accrued Rights; Surviving Obligations.  





 






  Master In Vitro Diagnostics Agreement 25 of [33] CONFIDENTIAL    10.8.1. Termination of this Agreement for any reason shall be without prejudice  to any rights that shall have accrued to the benefit of a Party prior to such termination, including, for  clarity, any payments owed to FMI in relation to the period prior to such termination, regardless of  whether a termination fee is paid.  Such termination shall not relieve a Party from obligations that are  expressly indicated to survive the termination or expiration of this Agreement.  Without limiting the  foregoing, Sections 2.4.2, 2.4.3, 2.5.1(i) (first and second sentences only, except as otherwise provided in  this Section 10.8.1), [**] (in each case, to the extent provided in Section 10.6.1 or 10.8.2), 2.5.1(ii) (last  sentence only), 2.5.2(i) (first and second sentences only), [**], 2.7, 3.4, 5.4 (as to amounts accrued as of  the effective date of termination and, mutatis mutandis, amounts owed pursuant to Section 10.6.2 or  otherwise upon or after termination), 6.1, 6.2.2 (to the extent provided in Section 10.6.1 [**]), 6.2.3 (to  the extent the license in Section 6.2.2 survives), 6.3 [**], and only to the extent provided in Section 10.6.1  [**]), 6.4.3, 6.5 (and Attachment B), 6.6, 8.3, 10.5, 10.6, 10.7 and this Section 10.8 and Article 1 (to the  extent necessary to interpret the remaining surviving provisions), Article 7 (in case of Sections 7.1 and  7.2, for the period set forth in Section 7.1.1), Article 9 and Article 11 (for clarity, including Section 11.19)  (provided, however, that Section 11.5 shall survive solely for purposes of any Dispute arising in  connection with the application of Section 10.6 or this Section 10.8 or any Dispute arising prior to the  effective date of termination) shall survive the termination or expiration of this Agreement for any reason.   10.8.2. If this Agreement is terminated with respect to any Program pursuant to  Section 10.2 or 10.4, then following such termination, the provisions of this Agreement shall remain in  effect, except that the rights and obligations of the Parties hereunder shall exclude rights and obligations  to the extent directed to such Program, and such Program shall be excluded from the role and  responsibilities of the JPTs; provided, however, that (a) subject to clauses (b) and (c) below, each of the  provisions listed in the last sentence of Section 10.8.1 shall survive with respect to such Program (as  would apply in the case of termination of this Agreement in its entirety), (b) if this Agreement is  terminated with respect to such Program (or in its entirety) by Company pursuant to Section 10.2 after the  filing of an application for Regulatory Approval of the applicable FMI Assay for use with the applicable  Company Product for the applicable Market and Indication, then (1) [**].  10.8.3. Except to the extent otherwise expressly provided in this Agreement,  including Sections 10.6.2, 10.8.1 or 10.8.2, or in any applicable SOW, (i) in the case of any termination of  this Agreement in its entirety, all SOWs shall terminate in their entirety and the provisions thereof shall  not survive after the applicable termination date, and (ii) in the case of any termination of this Agreement  with respect to a Program, (a) any SOW that covers such Program [**] shall terminate in its entirety and  the provisions thereof shall not survive after the applicable termination date, (b) any SOW that covers  such Program and one or more other Programs shall terminate [**], and (c) any SOW that does not cover  such Program shall not terminate, and the provisions thereof remain in effect without modification.  ARTICLE 11  MISCELLANEOUS  11.1. Force Majeure.  In the event either Party shall be delayed or hindered in or  prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor  troubles, restrictive government or judicial orders or decrees, riots, insurrection, war, acts of God,  inclement weather, disease outbreak, epidemic, pandemic or other similar reason or a cause beyond such  Party’s control (including, for clarity, the COVID-19 pandemic or any associated government restrictions  or disruptions or shortages of labor, materials or power, communications, transportation or other similar  services), then performance of such act shall be excused for the period of such delay, other than the  payment of monies when due hereunder.  Any timelines affected by such force majeure shall be extended  for a period equal to that of the delay.  Notice of the start and stop of any such force majeure shall be  provided to the other Party.    





 






  Master In Vitro Diagnostics Agreement 26 of [33] CONFIDENTIAL    11.2. Export Control.  This Agreement is made subject to any restrictions concerning  the export of products or technical information from the United States or other countries that may be  imposed on the Parties from time to time.  Each Party agrees that it will not export, directly or indirectly,  any technical information acquired from the other Party under this Agreement or any products using such  technical information to a location or in a manner that at the time of export requires an export license or  other governmental approval, without first obtaining the written consent to do so from the appropriate  agency or other governmental entity in accordance with Applicable Law.  11.3. Subcontracting.  Subject to the terms of this Agreement, each Party shall have  the right to engage Affiliates or Third Parties (including in connection with the grant of a license to one or  more Third Party (sub)licensees) to perform its obligations under this Agreement (each such Third Party,  a “Subcontractor”); [**] the extent that a Party utilizes its Affiliates or engages Subcontractors after the  Effective Date to perform tasks within the scope of any SOW, such Party shall ensure all such Affiliates  or Subcontractors are obligated to treat the other Party’s Confidential Information as confidential based  on commercially reasonable terms and conditions.  [**].  11.4. Assignment; Affiliates.  11.4.1. Except as provided in Section 11.3, neither this Agreement nor any rights  or obligations hereunder shall be assignable or otherwise transferable, in whole or in part, by a Party  without the prior written consent of the other Party, except that each Party shall have the right, without  such consent (but subject to Section 5.3 in the case of Company), to effect such assignment or transfer, in  whole but not in part: (i) to any of its Affiliates (provided, however, that under this clause (i) the  assigning Party shall remain responsible to the other Party for the performance of any such assigned or  transferred obligations), or (ii) to any successor in interest (whether by merger, acquisition or asset  purchase) to all or substantially all of the business to which this Agreement relates including, for clarity,  in the case of FMI, to any successor in interest to its business with respect to the FMI Assay(s) intended  for use with any Company Product; provided, however, that the assigning or transferring Party shall  provide written notice to the other Party within [**] days after such assignment or transfer.  All validly  assigned or transferred rights or obligations of a Party shall inure to the benefit of and be enforceable by,  or be binding on and be enforceable against, as applicable, the permitted successors and assigns of such  Party.  Any attempted assignment or other transfer in violation of this Section 11.4.1 shall be void and of  no effect.    11.4.2. The rights to Know-How or other information, materials and intellectual  property: (i) controlled by a Third Party permitted assignee of a Party that were controlled by such  assignee (and not such Party) immediately prior to such assignment (other than as a result of a license or  other grant of rights, covenant or assignment by such Party or its Affiliates to, or for the benefit of, such  Third Party); or (ii) controlled by an Affiliate of a Party that becomes an Affiliate through any direct or  indirect Change of Control of such Party or parent of such Party, that were controlled by such Affiliate  (and not such Party) immediately prior to such Change of Control (other than as a result of a license or  other grant of rights, covenant or assignment by such Party or its other Affiliates to, or for the benefit of,  such Affiliate), [**].  11.4.3. Notwithstanding the foregoing, each Party shall have the right to perform  any or all of its obligations and exercise any or all of its rights under this Agreement through any  Affiliate, and, in the case of FMI, through any FMI Contracting Collaborator.  11.5. Dispute Resolution.  11.5.1. Referral to Senior Officers.  Except with respect to matters reserved for  the final decision-making authority of one Party or the other pursuant to Section 4.2.1 or as provided in  





 






  Master In Vitro Diagnostics Agreement 27 of [33] CONFIDENTIAL    Section 11.10, if a dispute arises between the Parties in connection with or relating to this Agreement  (including any SOW), or any document or instrument delivered in connection herewith (each, a  “Dispute”), then either Party shall have the right to refer such Dispute to the Senior Officers for  attempted resolution by good faith negotiations during a period of [**] business days.  For clarity, matters  reserved for the final decision-making authority of a Party pursuant to Section 4.2.1 and matters that are  subject to the provisions of Section 11.10 shall not be referable to Senior Officers for resolution.    11.5.2. Resolution.  Any final decision mutually agreed to in writing by the  Senior Officers shall be conclusive and binding on the Parties.  If the Senior Officers are unable to resolve  any such Dispute within the period set forth in Section 11.5.1, then: (i) [**]; and (ii) except as provided in  clause (i), with respect to any other unresolved Dispute, either Party shall be free to exercise any right of  such Party to institute litigation in accordance with Section 11.6.  11.5.3. Interim Relief.  Notwithstanding anything herein to the contrary,  nothing contained in this Section 11.5 shall preclude either Party from seeking interim or provisional  relief, including a temporary restraining order, preliminary injunction or other interim equitable relief,  including concerning a Dispute, if reasonably necessary to protect the interests of such Party.  This  Section 11.5.3 shall be specifically enforceable.  11.6. Governing Law, Jurisdiction and Service.  This Agreement shall be governed  by and construed in accordance with the laws of the State of New York, excluding any conflicts or choice  of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the  substantive law of another jurisdiction.  The Parties agree to exclude the application to this Agreement of  the United Nations Convention on Contracts for the International Sale of Goods.  The Parties hereby  irrevocably and unconditionally consent to the exclusive jurisdiction of the courts of the Southern District  of New York for any action, suit or proceeding (other than appeals therefrom) arising out of or relating to  this Agreement and agree to not commence any action, suit or proceeding (other than appeals therefrom)  related thereto except in such courts.  The Parties irrevocably and unconditionally waive their right to a  jury trial.  The Parties further hereby irrevocably and unconditionally waive any objection to the laying of  venue of any action, suit or proceeding (other than appeals therefrom) arising out of or relating to this  Agreement in the courts of the Southern District of New York and hereby further irrevocably and  unconditionally waive and agree to not plead or claim in any such court that any such action, suit or  proceeding brought in any such court has been brought in an inconvenient forum.  Each Party further  agrees that service of any process, summons, notice or document by registered mail to its address set forth  in Section 11.7 shall be effective service of process for any action, suit or proceeding brought against it  under this Agreement in any such court.     11.7. Notices.  Any notice, request, demand, waiver, consent, approval or other  communication permitted or required under this Agreement shall be in writing, shall refer specifically to  this Agreement (and any applicable SOW) and shall be deemed given only if delivered by hand or sent by  electronic transmission (with transmission confirmed) or by an internationally recognized overnight  delivery service that maintains records of delivery, addressed to a Party at its respective address specified  below or to such other address as the Party to whom notice is to be given may have provided to the other  Party in accordance with this Section 11.7.  Such notice shall be deemed to have been given as of the date  delivered by hand or electronically transmitted (with transmission confirmed) or on the second business  day (at the place of delivery) after deposit with an internationally recognized overnight delivery service.   Any notice with respect to any Dispute or breach (or alleged breach) or termination of this Agreement  that is delivered by electronic transmission shall be confirmed by a hard copy delivered as soon as  practicable thereafter.  This Section 11.7 is not intended to govern the day-to-day business  communications between the Parties in performing their obligations under the terms of this Agreement or  any SOW.  





 






  Master In Vitro Diagnostics Agreement 28 of [33] CONFIDENTIAL    If to Company, to:   Arvinas Operations, Inc.  5 Science Park   395 Winchester Avenue  New Haven, CT 06511 U.S.A.  Attention: Legal Department  Facsimile: N/A  Email: [**]      If to Company Parent, to:  Arvinas, Inc.  5 Science Park  395 Winchester Avenue  New Haven, CT 06511 U.S.A  Attention: Legal Department  Facsimile: N/A  Email: [**]    If to FMI, to:  Foundation Medicine, Inc.  10 Canal Park  Cambridge, MA 02141 U.S.A.  Attention: VP, Business Development  Facsimile: [**]    With a copy to:    Foundation Medicine, Inc.  10 Canal Park  Cambridge, MA 02141 U.S.A.  Attention: General Counsel  Email: [**]      11.8. Entire Agreement; Amendments.  This Agreement, together with any and all  SOWs executed hereunder and incorporated herein, and any Appendix, Attachment, Annex or Schedule  hereto or thereto, sets forth and constitutes the entire agreement and understanding between the Parties  with respect to the subject matter hereof, and all prior agreements, understandings, promises and  representations, whether written or oral, with respect thereto, including the Mutual Confidentiality  Agreement entered into by Company and FMI dated as of August 30, 2021, are superseded hereby.  Each  Party confirms that it is not relying on any representations or warranties of the other Party except as  specifically set forth in this Agreement.  No amendment, modification, release or discharge with respect  to this Agreement (including any SOW) shall be binding upon the Parties unless in writing and duly  executed by an authorized representative of each Party.  Subject to Section 2.1.1, in the event of any  inconsistencies between this Agreement and any schedules or other attachments hereto (including any  SOW), the terms of this Agreement shall control.    11.9. English Language.  This Agreement shall be written and executed in and all  other communications under or in connection with this Agreement shall be in, the English language.  Any  translation into any other language shall not be an official version thereof and in the event of any conflict  in interpretation between the English version and such translation, the English version shall control.  11.10. Equitable Relief.  Each Party acknowledges and agrees that the restrictions set  forth in Article 6 and Article 7 are reasonable and necessary to protect the legitimate interests of the other  Party and that such other Party would not have entered into this Agreement in the absence of such  restrictions and that any breach or threatened breach of any provision of such Articles may result in  irreparable injury to such other Party for which there will be no adequate remedy at law.  In the event of a  breach or threatened breach of any provision of such Articles, the non-breaching Party shall be authorized  and entitled to seek from any court of competent jurisdiction injunctive relief, whether preliminary or  permanent and specific performance, which rights shall be cumulative and in addition to any other rights  or remedies to which such non-breaching Party may be entitled in law or equity.  Each Party agrees to  waive any requirement that the other Party (i) post a bond or other security as a condition for obtaining  any such relief or (ii) show irreparable harm, balancing of harms, consideration of the public interest or  inadequacy of monetary damages as a remedy.  Nothing in this Section 11.10 is intended or should be  





 






  Master In Vitro Diagnostics Agreement 29 of [33] CONFIDENTIAL    construed, to limit either Party’s right to equitable relief or any other remedy for a breach of any other  provision of this Agreement.  11.11. Waiver and Non-Exclusion of Remedies.  Any term or condition of this  Agreement (including any SOW) may be waived at any time by the Party that is entitled to the benefit  thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or  on behalf of the Party waiving such term or condition.  The waiver by either Party of any right under this  Agreement, or of the failure to perform or of a breach by the other Party, shall not be deemed a waiver of  any other right under this Agreement or of any other breach or failure by such other Party whether of a  similar nature or otherwise.  The rights and remedies provided herein are cumulative and do not exclude  any other right or remedy provided by Applicable Law or otherwise available except as expressly set forth  herein.  11.12. No Benefit to Third Parties.  Except as specifically provided in Sections 9.1  and 9.2, the covenants and agreements set forth in this Agreement are for the sole benefit of the Parties  and their successors and permitted assigns and they shall not be construed as conferring any rights on any  other Persons.  11.13. Further Assurance.  Each Party shall duly execute and deliver or cause to be  duly executed and delivered, such further instruments and do and cause to be done such further acts and  things, including the filing of such assignments, agreements, documents and instruments, as may be  reasonably necessary or as the other Party may reasonably request in connection with this Agreement or  to carry out more effectively the provisions and purposes hereof or to better assure and confirm unto such  other Party its rights and remedies under this Agreement.  11.14. Relationship of the Parties.  It is expressly agreed that FMI and Company shall  be independent contractors and that the relationship between the Parties under this Agreement and any  SOW(s) shall not constitute a partnership, joint venture or agency.  Neither FMI nor Company shall have  the authority to make any statements, representations or commitments of any kind, or to take any action  that will be binding on the other, without the prior written consent of the other Party to do so.  All persons  employed by a Party shall be employees of such Party and not of the other Party, and all costs and  obligations incurred by reason of any such employment shall be for the account and expense of such first  Party.  11.15. References.  Unless otherwise specified, (i) references in this Agreement to any  Article, Section, Appendix, Attachment, Annex or Schedule shall mean references to such Article,  Section, Appendix, Attachment, Annex or Schedule of this Agreement; (ii) references in any Section to  any clause are references to such clause of such Section; and (iii) references to any agreement, instrument  or other document in this Agreement refer to such agreement, instrument or other document as originally  executed or, if subsequently amended, restated, replaced or supplemented from time to time, as so  amended, replaced or supplemented and in effect at the relevant time of reference thereto.  11.16. Construction.  Except where the context otherwise requires, wherever used, the  singular shall include the plural, the plural the singular, the use of any gender shall be applicable to all  genders and the word “or” is used in the inclusive sense (and/or).  Whenever this Agreement refers to a  number of days, unless otherwise specified, such number refers to calendar days.  To the extent any  provision of this Agreement requires for any purpose a Party’s consent or approval, such consent or  approval shall not be unreasonably withheld, conditioned or delayed, unless otherwise expressly  provided.  The headings of this Agreement are for convenience of reference only and in no way define,  describe, extend or limit the scope or intent of this Agreement or the intent of any provision contained in  this Agreement.  Each of the terms “including,” “include,” or “includes” as used herein shall mean  including, without limiting the generality of any description preceding each such term.  Any capitalized  





 






  Master In Vitro Diagnostics Agreement 30 of [33] CONFIDENTIAL    term used in any SOW but not otherwise defined therein shall have the meaning provided in this  Agreement.  The language of this Agreement shall be deemed to be the language mutually chosen by the  Parties and no rule of strict construction shall be applied against either Party.  11.17. Severability.  If any one or more provisions of this Agreement shall be found to  be illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining  provisions shall not in any way be affected or impaired thereby, provided the surviving agreement  materially comports with the Parties’ original intent.  The Parties agree that any such illegal or  unenforceable provisions will be deemed replaced with valid and enforceable provisions that achieve, to  the extent possible, the business purposes and intent of such invalid and unenforceable provisions.  11.18. Counterparts.  This Agreement and any SOW(s) may be executed in  counterparts, each of which shall be deemed an original, but all of which together shall constitute one and  the same instrument.  This Agreement and any SOW(s) may be executed by facsimile, PDF format via  email or other electronically transmitted signatures and such signatures shall be deemed to bind each  Party as if they were original signatures.  11.19. [**].  SIGNATURE PAGE FOLLOWS. 





 






      Signature Page to Master In Vitro Diagnostics Agreement      Master In Vitro Diagnostics Agreement Page 31 of [33] CONFIDENTIAL    IN WITNESS THEREOF, this Agreement has been executed by the Parties and Company Parent through  their duly authorized representatives as of the Effective Date.    ARVINAS OPERATIONS, INC. FOUNDATION MEDICINE, INC.    By: /s/ Sean Cassidy By: /s/ John Truesdell    Name: Sean Cassidy  Name: John Truesdell     Title: CFO  Title: VP Biopharma Partnership Development       ARVINAS, INC.    By: /s/ Sean Cassidy     Name: Sean Cassidy      Title: CFO    





 






ACTIVE/117906126.4       Master In Vitro Diagnostics Agreement Page 32 of 33 CONFIDENTIAL