CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([***]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT This...
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CERTAIN INFORMATION IDENTIFIED BY BRACKETED ASTERISKS ([***]) HAS BEEN OMITTED FROM THIS EXHIBIT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. AMENDED AND RESTATED COLLABORATION AND LICENSE AGREEMENT This AMENDED AND RESTATED CLINICAL TRIAL COLLABORATION AND LICENSE AGREEMENT (this “Agreement”), made as of 6 September 2022 (the “Effective Date”), is by and between GlaxoSmithKline Intellectual Property Development Limited a company registered in England and Wales (registered number 08283222) and having business offices at 000 Xxxxx Xxxx Xxxx, Xxxxxxxxx, Xxxxxxxxx, XX0 0XX, Xxxxxxx (“GSK”) and SpringWorks Therapeutics, Inc., a Delaware corporation, having a place of business at 000 Xxxxxxxxxx Xxxx., 0xx Xxxxx, Xxxxxxxx, XX 00000 (“SpringWorks”). SpringWorks and GSK are each referred to herein individually as a “Party” and collectively as the “Parties”. RECITALS A. WHEREAS, GSK is developing belantamab mafodotin-blmf, a humanized (IgG1) antibody drug conjugate that binds specifically to a B-cell maturation antigen for the treatment of multiple myeloma and other BCMA-expressing malignancies (“Belamaf”); B. WHEREAS, SpringWorks is developing nirogacestat, a gamma secretase inhibitor (GSI) which specifically downregulates NOTCH target gene expression and reduces cleavage of B-cell maturation antigen for the treatment of certain human tumors (“Nirogacestat”); C. WHEREAS, the Parties entered into that certain Clinical Trial Collaboration and Supply Agreement dated 25 June 2019 (the “Original Effective Date”), as amended on 22 October 2021, in relation to a clinical trial testing Belamaf and Nirogacestat as a combination therapy for the treatment of relapsed refractory multiple myeloma (the “Original Agreement”); and D. WHEREAS, the Parties desire to amend and restate the Original Agreement to permit the development and commercialization of the Combination Regimens (as defined below) in the Field (as defined below) on the terms and conditions set forth herein. NOW, THEREFORE, in consideration of the premises and of the following mutual promises, covenants and conditions, the Parties, intending to be legally bound, mutually agree as follows: 1. DEFINITIONS. For all purposes of this Agreement, the capitalized terms defined in this Article 1 and throughout this Agreement shall have the meanings herein specified. 1.1 “Affiliate” means, with respect to either Party, a firm, corporation or other entity which directly or indirectly owns or controls said Party, or is owned or controlled by said Party, or is under common ownership or control with said Party. The word “control” means (a) the direct or indirect ownership of fifty percent (50%) or more of the outstanding voting securities of a legal entity, or (b) possession, directly or indirectly, of the power to direct the management or policies of a legal entity, whether through the ownership of voting securities, contract rights, voting rights, corporate governance or otherwise. 1.2 “Agreement” has the meaning set forth in the preamble.
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CONFIDENTIAL Page 2 1.3 “Alliance Manager” has the meaning set forth in Section 6.9. 1.4 “Applicable Law” means all federal, state, local, national and regional statutes, laws, rules, regulations and directives applicable to a particular activity hereunder, including performance of clinical trials, medical treatment and the processing and protection of personal and medical data, that may be in effect from time to time including those promulgated by the United States Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) and any successor agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union, and including cGMP and GCP; Data Protection Laws; export control and economic sanctions regulations which prohibit the shipment of United States-origin products and technology to certain restricted countries, entities and individuals; anti-bribery and anti-corruption laws and regulations governing payments to healthcare providers, including the Physician Payment Sunshine Act and state gift laws, and the European Federation of Pharmaceutical Industries and Associations Disclosure Code; and any United States or other country’s or jurisdiction’s successor or replacement statutes, laws, rules, regulations and directives relating to the foregoing. 1.5 “Approved Vendor(s)” has the meaning set forth in Section 9.3. 1.6 “Assignment” has the meaning set forth in Section 4.7. 1.7 “BCMA” means B-cell maturation antigen. 1.8 “Belamaf” has the meaning set forth in the Recitals hereto. 1.9 “Bioanalytical Testing” has the meaning set forth in Section 9.3. 1.10 “Biomarkers” mean any naturally occurring molecule, gene or characteristic by which a particular pathological or physiological process can be identified and serially monitored during a therapeutic intervention, including blood (including cells, RNA and circulating multiple myeloma cells (CMMCs)), serum (including cytokines and sBCMA), plasma (including cfDNA), tissue and tumors (including FFPE bone marrow aspirate and biopsy Samples). 1.11 “Biomarker Testing” has the meaning set forth in Section 9.2. 1.12 “Business Day” means any day other than (a) a Saturday, Sunday or any public holiday in Boston, Massachusetts or London, England; and (b) a day falling within the time period from and including 24 December up to and including 1 January. 1.13 “cGMP” means the current Good Manufacturing Practices officially published and interpreted by EMA, FDA and other applicable Regulatory Authorities that may be in effect from time to time and are applicable to the Manufacture of the Compounds. These include requirements set forth in FDA’s regulations at 21 CFR Parts 11, 210, 211 and 600, as applicable to the processing, manufacture, handling, receipt, packaging, labelling, release and distribution of products and services subject to this Agreement. 1.14 “Change of Control” of a Party means any of the following, in a single transaction or a series of related transactions: (a) the sale or disposition of all or substantially all of the assets of such Party to a Third Party, (b) the direct or indirect acquisition by a Third Party (other than an employee benefit plan (or related trust) sponsored or maintained by such Party or any of its Affiliates) of beneficial ownership of more than fifty percent (50%) of
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CONFIDENTIAL Page 3 the then-outstanding common shares or voting power of such Party or any direct or indirect entity which holds, directly or indirectly, beneficial ownership of more than fifty percent (50%) of the then-outstanding common shares or voting power of such Party (a “Parent Entity”), (c) the merger or consolidation of such Party or any Parent Entity with or into a Third Party, unless, following such merger or consolidation, the stockholders of such Party or Parent Entity immediately prior to such merger or consolidation beneficially own directly or indirectly more than fifty percent (50%) of the then-outstanding common shares or voting power of the entity resulting from such merger or consolidation or (d) a change in the possession, directly or indirectly, of the power to direct, or cause the direction of, the management or policies of such Party, whether through the ownership of voting securities, by contract or otherwise. 1.15 “Clinical Data” means all data (including raw data) and results generated under the Sub- Study and/or activities conducted under the Development Plan, including all Sample Testing Results. 1.16 “Clinical Hold” means that (a) the FDA has issued an order to a Party pursuant to 21 CFR 312.42 to delay a proposed clinical investigation or to suspend an ongoing clinical investigation of the Combination Regimen or such Party’s Compound in the United States, or (b) a Regulatory Authority other than the FDA has issued an equivalent order to that set forth in (a) in any other country or group of countries. 1.17 “Clinical Quality Agreement” means that certain Clinical Quality Agreement entered into by the Parties under the Original Agreement, as may be amended pursuant to Section 11 hereof. 1.18 “Clinical Study” means any clinical trial for a compound or product in humans that is designed to generate data in support or maintenance of Regulatory Approval including any post-approval clinical trial in humans, but excluding any investigator-sponsored clinical trial. 1.19 “Combination Regimen” means the use or method of using any GSK BCMA Product and the SpringWorks Compound in combination, either alone together as a combination therapy, or as a combination together with additional pharmaceutical agents, whether administration is concomitant or sequential administration. 1.20 “Commercialization” or “Commercialize” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a product, including activities directed to Promoting, distributing, importing, exporting and selling a product and interacting with Regulatory Authorities regarding any of the foregoing. 1.21 “Commercialization Territory” means the Required Territory and any other countries or territories for which the Parties agree via the JCC to seek Regulatory Approval of the Combination Regimen. 1.22 “Commercially Reasonable Efforts” means [***]. 1.23 “Committees” has the meaning set forth in Section 6.5. 1.24 “Compounds” means any, some or all of the GSK BCMA Products and the SpringWorks Compound. A “Compound” means any of the GSK BCMA Products or the SpringWorks Compound, as applicable.
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CONFIDENTIAL Page 4 1.25 “Compound Trademarks” means any proprietary trademark or service mark used by either Party or their Affiliates in connection with the distribution, marketing, promotion and sale of such Party’s Compound in the Field anywhere in the world, or accompanying logos, trade dress or indicia of origin. For the avoidance of doubt, Compound Trademarks do not include the international non-proprietary name of any Compound. 1.26 “Confidential Information” means any Know-How or other proprietary information or materials, whether in written, visual, oral or electronic or any other format, both technical and non-technical, disclosed to one Party by the other Party pursuant to this Agreement, the Original Agreement or prior to the Original Effective Date or otherwise belonging to a Party pursuant to this Agreement and relating to matters contemplated by this Agreement, except to the extent that it can be established by the receiving Party that such information or materials: (a) were already known to the receiving Party, other than under an obligation of confidentiality, either (i) at the time of disclosure by the other Party, or (ii) if applicable, at the time that it was generated hereunder, whichever of (i) or (ii) is earlier, in each case as demonstrated by competent business records; (b) were generally available to the public or otherwise part of the public domain either (i) at the time of its disclosure to the receiving Party, or (ii) if applicable, at the time that it was generated hereunder, whichever of (i) or (ii) is earlier; (c) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of the receiving Party in breach of this Agreement; (d) were disclosed to the receiving Party by a Third Party who had no obligation to the disclosing Party not to disclose such information to others; or (e) were subsequently independently developed by the receiving Party (or its Affiliates) without use of, or reference to, the Confidential Information as demonstrated by competent business records. 1.27 “Continuing Party” has the meaning set forth in Section 17.4(b). 1.28 “CSR” has the meaning set forth in Section 4.9(a). 1.29 “CTA” means an application to a Regulatory Authority for purposes of requesting the ability to start or continue a clinical trial. 1.30 “Data Protection Law” means all applicable laws, rules and regulations, including the United States Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”), the California Consumer Privacy Act of 2018 (“CCPA”) (to the extent applicable), and any supranational or national legislation relating to privacy and data protection, direct marketing or the interception or communication of electronic messages, in each case as amended, consolidated, re-enacted or replaced from time to time, including, to the extent applicable, European Data Protection Laws. 1.31 “Data Security Breach” has the meaning set forth in Section 14.5. 1.32 “Data Sharing Initiative” means GSK’s policy initiative (as may be amended from time to time), known at the Effective Date as the “SHARE Initiative”, to provide researchers with access to Clinical Study and study information, including anonymized patient level data, as such initiative is described on xxxxx://xxx.xxxxxxxxxxxxxxxxxxxxxxxx.xxx/. 1.33 “Data Subject” means an identified or identifiable natural person. An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, an identification number, location data, an online identifier or to
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CONFIDENTIAL Page 5 one or more factors specific to the physical, physiological, genetic, mental, economic, cultural or social identity of that natural person. 1.34 “Data Subject Request” has the meaning set forth in Section 15.13. 1.35 “Debarred” or “Debarment” means that a Party or any of its officers or directors or any other personnel (or other permitted agents of a Party hereunder) has been: (a) convicted of any of the offenses identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7 (xxxx://xxx.xxx.xxx/xxxxxxxxxx/xxxxxxxxxxx.xxx); (b) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (xxxx://xxxxxxxxxx.xxx.xxx.xxx/) or listed as having an active exclusion in the System for Award Management (xxxx://xxx.xxx.xxx); or (c) disqualified or proposed by FDA for disqualification from receiving investigational products, conducting clinical studies or providing any services in any capacity to a person that has an approved or pending drug product application or listed by any US Federal agency as being suspended, proposed for debarment, debarred, suspended, excluded or otherwise ineligible to participate in Federal procurement or non-procurement programs, including under 21 U.S.C. 335a (xxxx://xxx.xxx.xxx/xxx/xxxxxxxxxx_xxx/xxxxx/). 1.36 “Delivery” has the meaning set forth in Section 12.7. 1.37 “Development” or “Develop” means non-clinical and clinical research and drug development activities including Clinical Studies, including toxicology, pharmacology and other discovery efforts, test method development and stability testing, assay development, cell line development, process development and improvement, process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, statistical analysis, regulatory affairs related to obtaining Regulatory Approvals and conducting Clinical Studies, Medical Affairs activities, and all other activities, including any post-marketing commitments, necessary or reasonably useful or otherwise requested or required by a Regulatory Authority as a condition or in support of obtaining or maintaining a Regulatory Approval and, to the extent not included in the foregoing, any other activities set out in the Development Plan. 1.38 “Development Plan” has the meaning set forth in Section 3.1. 1.39 “Disclosing Party” has the meaning set forth in Section 15.1. 1.40 “Dispute” has the meaning set forth in Section 30.2. 1.41 “Effective Date” has the meaning set forth in the preamble. 1.42 “EMA” has the meaning set forth in the definition of Applicable Law. 1.43 “Entity” has the meaning set forth in Section 13.12. 1.44 “European Data Protection Laws” means the General Data Protection Regulation 2016/679 (the “GDPR”), the e-Privacy Directive 2002/58/EC, the Privacy and Electronic Communications Regulations 2003, the UK Data Protection Xxx 0000 (“DPA”), the UK General Data Protection Regulation as defined by the DPA as amended by the Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (together with the DPA, the “UK GDPR”), and any relevant law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or
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CONFIDENTIAL Page 6 other binding instrument which implements, replaces, adds to, amends, extends, reconstitutes or consolidates such laws from time to time, in each case as amended, consolidated, re-enacted or replaced from time to time. 1.45 “Executive Officers” means (i) for SpringWorks, the Chief Executive Officer of SpringWorks (or a senior executive officer of SpringWorks designated by SpringWorks’ Chief Executive Officer) and (ii) for GSK, the Chief Scientific Officer and President of R&D or equivalent (or a senior executive officer of GSK designated by GSK’s Chief Scientific Officer and President of R&D or equivalent). In the event that the position of any of the Executive Officers identified in this Section 1.45 no longer exists due to a corporate reorganization, corporate restructuring or the like that results in the elimination of the identified position, the applicable Executive Officer shall be replaced with another executive officer with responsibilities and seniority comparable to the eliminated Executive Officer. 1.46 “FDA” has the meaning set forth in the definition of Applicable Law. 1.47 “Field” means the prevention, treatment and prophylaxis of multiple myeloma and other BCMA-expressing malignancies and diseases. 1.48 “Filing Party” has the meaning set forth in Section 17.4(b). 1.49 “First Commercial Sale” means (a) in any country in the Required Territory in which GSK has filed for Regulatory Approval of a GSK BCMA Product for use as part of a Combination Regimen, the first commercial sale of a GSK BCMA Product in the applicable country or territory in the Required Territory in an arm’s length transaction to a Third Party by GSK or any of its Affiliates or Sublicensees, following GSK’s or any of its Affiliates’ or Sublicensees’ receipt of all applicable Regulatory Approvals (including, for the avoidance of doubt, Pricing and Reimbursement Approvals) of such GSK BCMA Product for use as part of a Combination Regimen in such country or territory, or (b) in any other country in the Required Territory, the first commercial sale of a GSK BCMA Product in the applicable country or territory in the Required Territory in an arm’s length transaction to a Third Party by GSK or any of its Affiliates or Sublicensees, following SpringWorks’ or any of its Affiliates’ or Sublicensees’ receipt of all applicable Regulatory Approvals (including, for the avoidance of doubt, Pricing and Reimbursement Approvals) of the SpringWorks Compound for use as part of a Combination Regimen in such country or territory. First Commercial Sale will not include any distribution or other sale solely for patient assistance, named patient use, compassionate use, or other patient access programs, or test marketing programs, clinical trials, non-registrational studies or similar programs or studies. 1.50 “First Party” has the meaning set forth in Section 13.15(b). 1.51 “GCP” means the Good Clinical Practices officially published by EMA, FDA and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) that may be in effect from time to time and are applicable to the testing of the Compounds, including the requirements set forth at 21 CFR Parts 50, 54, 56 and 312. 1.52 “Government Official” means (a) any officer or employee of a government or any department, agency or instrumentality of a government (which includes public enterprises and entities owned or controlled by the state); (b) any officer or employee of a public
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CONFIDENTIAL Page 7 international organization such as the World Bank or United Nations; (c) any officer or employee of a political party or any candidate for public office; (d) any person defined as a government or public official under Applicable Laws (including anti-bribery and corruption laws) and not already covered by any of the above; and/or; (e) any person acting in an official capacity for or on behalf of any of the above, including in each case any person with close family members who are Government Officials with the capacity, actual or perceived, to influence or take official decisions affecting GSK or SpringWorks business. For the purposes of this definition, “government” means all levels and subdivisions of government, e.g. local, regional, national, administrative, legislative, executive, or judicial and royal or ruling families. 1.53 “GSK” has the meaning set forth in the preamble. 1.54 “GSK Background Intellectual Property” means any Intellectual Property Rights owned or controlled by GSK or an Affiliate of GSK that (a) exist as of the Original Effective Date or (b) arise outside of (i.e., is not made or conceived in or through) the conduct of activities under this Agreement (including, for the avoidance of doubt, activities conducted under the Original Agreement) or without the use of or reliance upon the Licensed Clinical Data, the Confidential Information solely owned or controlled by SpringWorks, or the SpringWorks Compound. 1.55 “GSK BCMA Products” means the monoclonal antibody known as belantamab or any cytotoxic antibody-drug conjugate derived therefrom controlled by GSK, including but not limited to Belamaf. 1.56 “GSK Invention” has the meaning set forth in Section 17.2. 1.57 “GSK IPR” has the meaning set forth in Section 17.2. 1.58 “GSK Regulatory Documentation” means any Regulatory Documentation pertaining to the GSK BCMA Product that exists as of the Original Effective Date or that is created other than in connection with this Agreement. For the avoidance of doubt, GSK Regulatory Documentation does not include Study Regulatory Documentation. 1.59 “GSK-Related Compound” has the meaning set forth in Section 16.3. 1.60 “HIPAA” has the meaning set forth in the definition of Data Protection Law. 1.61 “IND” means the Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an “Investigational Medicinal Product Dossier” filed or to be filed with the EMA. 1.62 “Initiation” means, with respect to a Clinical Study, the dosing of the first patient in such Clinical Study. 1.63 “Intellectual Property Rights” means all patents, inventions (whether patentable or not), discoveries, rights in confidential information, Know-How and trade secrets (and any documents containing such confidential information, Know-How or trade secrets), trademarks and service marks, copyrights (including in computer software) (in each case whether registered or not), registered designs, design rights, contractual waivers of moral rights, rights in databases and collections of data, utility models and all similar property rights whether or not registered or registrable, designs, drawings, performances, computer
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CONFIDENTIAL Page 8 programs, business or brand names, rights in domain names, metatags, goodwill or the style or presentation of goods or services and all similar property rights whether or not registered or registrable, including applications for protection, renewal or extension of any such rights, anywhere in the world and in each case whether subsisting now or in the future. 1.64 “JCC” has the meaning set forth in Section 6.3. 1.65 “JDC” has the meaning set forth in Section 6.2. 1.66 “Jointly Owned Study Invention” has the meaning set forth in Section 17.4(a). 1.67 “Joint Patent” means a patent, extension, registration, supplementary protection or certificate of the like that issues from a Joint Patent Application. 1.68 “Joint Patent Application” has the meaning set forth in Section 17.4(b). 1.69 “JSC” has the meaning set forth in Section 6.1. 1.70 “Know-How” means any proprietary invention, innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, including manufacturing, use, process, structural, operational and other data and information, whether or not written or otherwise fixed in any form or medium, regardless of the media on which contained and whether or not patentable or copyrightable, that is not generally known or otherwise in the public domain. 1.71 “Know-How Transfers” has the meaning set forth in Section 3.3. 1.72 “Liability” has the meaning set forth in Section 22.1. 1.73 “Licensed Clinical Data” means all tables, listings, figures and other aggregated analysis derived from the Clinical Data (in accordance with the applicable protocol for the relevant Clinical Study) that relates to the Combination Regimens or the SpringWorks Compound as a sole compound, but excluding any raw data (including Sample Testing Results) or any data (or any aggregated analysis thereof) relating to the GSK BCMA Product alone or use of the GSK BCMA Product in combination with any other compound in the Field. 1.74 “Manufacture,” “Manufactured,” or “Manufacturing” means all activities of the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labelling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable. 1.75 “Manufacturer’s Release” or “Release” means the certification of release of a production lot of a Compound in accordance with the Clinical Quality Agreement. 1.76 “Manufacturing Site” means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 12.10. 1.77 “Material Safety Issue” means a Party’s reasonable belief that there is an unacceptable risk for harm in humans based on: (a) pre-clinical safety data, including data from animal toxicology studies, or (b) the observation of serious adverse events in humans after a Party’s Compound, either as a single Compound or in combination with any other
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CONFIDENTIAL Page 9 pharmaceutical agent (including the Combination Regimens), has been administered to or taken by humans. 1.78 “Mechanism of Action” means the specific biological and/or chemical interaction(s) through which a drug substance produces its pharmacological effect(s). 1.79 “Medical Affairs” means any and all activities conducted by or on behalf of a Party or any of its Affiliates with respect to: communications with key opinion leaders, continuing medical education, symposia, advisory boards (to the extent related to medical affairs or clinical guidance), patient or consumer registries, and other medical programs and communications (including publications and exhibiting and presenting at seminars and conventions), health economic studies, health care professional programs, engaging medical science liaisons, and conducting medical science liaison activities. 1.80 “Milestone Event” has the meaning set forth in Section 13.2. 1.81 “Milestone Payment” has the meaning set forth in Section 13.2. 1.82 “Nirogacestat” has the meaning set forth in the Recitals hereto. 1.83 “Non-Conformance” has the meaning set forth to such term in the Clinical Quality Agreement. 1.84 “Non-Filing Party” has the meaning set forth in Section 17.4(b). 1.85 “Opting-out Party” has the meaning set forth in Section 17.4(b). 1.86 “Party” has the meaning set forth in the preamble. 1.87 “Personal Data” will be construed in accordance with the GDPR to the extent applicable. In all other instances, to the extent HIPAA applies, Personal Data means Protected Health Information subject to HIPAA. 1.88 “Pfizer Agreement” has the meaning set forth in Section 20.9. 1.89 “Pharmacovigilance Agreement” means that certain pharmacovigilance agreement entered into by the Parties under the Original Agreement, as may be amended pursuant to Article 10 hereof regarding safety-related activities in relation to the Compounds. 1.90 “Platform Study” means the Clinical Study entitled “Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 5) (NCT04126200)” that is sponsored by GSK, under which the Sub-Study is being conducted. 1.91 “Platform Study IND” has the meaning set forth in Section 4.5. 1.92 “Platform Study Protocol” means the written documentation which describes the Platform Study and sets forth specific activities to be performed as part of the Platform Study conduct. 1.93 “Pricing and Reimbursement Approval” means any approval, agreement, determination, or other decision by the applicable Regulatory Authority or other governmental authority
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CONFIDENTIAL Page 10 in a given country or other regulatory jurisdiction that establishes prices charged to end- users for a given pharmaceutical product at which such pharmaceutical product will be reimbursed by the applicable governmental authorities in such country or regulatory jurisdiction. For the avoidance of doubt, Pricing and Reimbursement Approval does not include any period of free pricing pending any decision by the applicable Regulatory Authority or other governmental authority. 1.94 “Promotion” or “Promoting” means any and all activities directed to the marketing and promotion of a product and interacting with Regulatory Authorities for related purposes following receipt of Regulatory Approval in the applicable country or region for such product regarding the foregoing. 1.95 “Protected Health Information” will be construed in accordance with HIPAA. 1.96 “Receiving Party” has the meaning set forth in Section 15.1. 1.97 “Regulatory Approvals” means, with respect to a Compound, any and all permissions required to be obtained from Regulatory Authorities and any other competent authority for the marketing, sale and distribution of such Compound in any applicable jurisdictions, including Pricing and Reimbursement Approval if necessary for the lawful commercial marketing, sale and distribution of such Compound in an applicable jurisdiction. For the avoidance of doubt, Regulatory Approval includes, in the United States, approval of a New Drug Application (“NDA”), Biologics License Application (“BLA”) or an equivalent by the FDA, and in the European Union, Regulatory Approval means approval of a Marketing Authorization Application (“MAA”) or an equivalent by the European Commission or applicable national Regulatory Authority. 1.98 “Regulatory Authorities” means any federal, national, multinational, state, provincial or local regulatory agency, department, bureau or other governmental entity with authority over the activities conducted under this Agreement, including performance of Clinical Studies, medical treatment and the processing and protection of personal and medical data or marketing and sale of a pharmaceutical product in a country. “Regulatory Authority” includes the FDA, the EMA and any successor agency to the FDA or EMA or any agency or authority performing some or all of the functions of the FDA or EMA in any jurisdiction outside the United States or the European Union. 1.99 “Regulatory Documentation” means, with respect to a Party’s Compound, all submissions to Regulatory Authorities in connection with the Development or Commercialization of such Compound or the Regulatory Approval of such Compound and all INDs and CTAs for such Compound and amendments thereto, including all drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents. 1.100 “Related Agreements” means the Pharmacovigilance Agreement and the Clinical Quality Agreement. 1.101 “Representatives” has the meaning set forth in Section 14.2. 1.102 “Requesting Party” has the meaning set forth in Section 7.6. 1.103 “Required Territory” means [***].
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CONFIDENTIAL Page 11 1.104 “Resulting Entity” has the meaning set forth in Section 4.7. 1.105 “Right of Reference” means allowing the applicable Regulatory Authority in a country to have access to relevant information (by cross-reference, incorporation by reference or otherwise) contained in any Regulatory Documentation (and any data contained therein) filed with such Regulatory Authority with respect to a Party’s Compound. 1.106 “Samples” means biological specimens collected from subjects participating in Clinical Studies under the Development Plan, including urine, blood and tissue samples. 1.107 “Sample Testing” means the analyses that may be performed by GSK using the applicable Samples, as permitted in accordance with this Agreement, including Bioanalytical Testing and Biomarker Testing. 1.108 “Sample Testing Results” means those data and results arising from the Sample Testing. 1.109 “Second Party” has the meaning set forth in Section 13.15(b). 1.110 “Segregate” means [***]. 1.111 “Specifications” means, with respect to a given Compound, the specifications for testing, release and stability of such Compound, as set forth in the applicable Regulatory Documentation for such Compound. 1.112 “SpringWorks” has the meaning set forth in the preamble. 1.113 “SpringWorks Background Intellectual Property” means any Intellectual Property Rights owned or controlled by SpringWorks or an Affiliate of SpringWorks that (a) exist as of the Original Effective Date or (b) arise outside of (i.e., is not made or conceived in or through) the conduct of activities under this Agreement (including, for the avoidance of doubt, activities conducted under the Original Agreement) or without the use of or reliance upon Clinical Data, the Confidential Information solely owned or controlled by GSK, or the GSK BCMA Products. 1.114 “SpringWorks Compound” means Nirogacestat or any polymorphs, salts or derivatives thereof controlled by SpringWorks. 1.115 “SpringWorks Invention” has the meaning set forth in Section 17.3. 1.116 “SpringWorks IPR” has the meaning set forth in Section 17.3. 1.117 “SpringWorks Regulatory Documentation” means any Regulatory Documentation pertaining to the SpringWorks Compound that exists as of the Original Effective Date or that is created other than in connection with this Agreement. For the avoidance of doubt, SpringWorks Regulatory Documentation does not include Study Regulatory Documentation. 1.118 “SpringWorks-Related Compound” means a compound that has the same Mechanism of Action as the SpringWorks Compound. 1.119 “Standard Contractual Clauses” means: (a) in relation to transfers of Personal Data subject to the GDPR, the standard contractual clauses for the transfer of Personal Data to third countries set out in Commission Decision 2021/914 of 4 June 2021, specifically
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CONFIDENTIAL Page 12 including Module 1 (Controller to Controller); and (b) in respect of transfers of Personal Data subject to the UK GDPR, the International Data Transfer Addendum to the EU Commission Standard Contractual Clauses (version B.1.0) issued by the UK Information Commissioner, in each case of (a) and (b) as amended, consolidated, re-enacted or replaced from time to time. 1.120 “Study Inventions” means all inventions and discoveries, whether or not patentable, that are made or conceived by either Party, its Affiliates or subcontractors, in the conduct of activities under this Agreement (including, for the avoidance of doubt, activities conducted under the Original Agreement) and/or that are made or conceived by a Party, its Affiliates or subcontractors, through use of the Licensed Clinical Data. 1.121 “Study Regulatory Documentation” means any Regulatory Documentation pertaining to the activities under the Development Plan whether created before, during or after the expiry of the Term. 1.122 “Sublicense” has the meaning set forth in Section 2.5. 1.123 “Sublicensee” means any person or entity to whom a Sublicense is granted in accordance with Section 2.4. 1.124 “Sub-Study” means the sub-studies under the Platform Study investigating the Combination Regimens for relapsed and refractory multiple myeloma performed under this Agreement and referred to as Sub-Study 3, Sub-Study 6 and Sub-Study 7 in the Development Plan. 1.125 “Supply Remediation Plan” has the meaning set forth in Section 8.2. 1.126 “Tax” means any present or future taxes, levies, imposts, duties, charges, assessments or fees in the nature of a tax imposed, collected or assessed by, or payable to, a Tax Authority (including interest, penalties and additions thereto). 1.127 “Tax Action” has the meaning set forth in Section 13.10. 1.128 “Tax Authority” means any government, state or municipality or any local, state, federal or other fiscal, revenue, customs or excise authority, body or official in the United Kingdom or elsewhere. 1.129 “Term” has the meaning set forth in Section 24.1. 1.130 “Third Party” means any person or entity other than GSK, SpringWorks or their respective Affiliates. 1.131 “Third Party License Payment” means any payment (e.g. upfront payment, milestone, royalty) due to any Third Party under license agreements or other written agreements granting rights to Intellectual Property Rights owned or controlled by such Third Party to the extent that such Intellectual Property Rights are necessary for (a) the making, using or importing of a Party’s Compound for the conduct of the activities under the Development Plan, (b) the conduct of the activities under the Development Plan, or (c) the Commercialization of a Party’s Compound in accordance with this Agreement.
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CONFIDENTIAL Page 16 Clinical Study would violate Applicable Law or would pose a safety risk for subjects participating in such Clinical Study. GSK shall make good faith efforts to consult with, and consider input from, SpringWorks before (and if not before, then promptly following) the termination of any activities based on such a determination. 4.5 As of the Effective Date, GSK is the sponsor of the Sub-Study, and is conducting the Sub- Study under the IND for the Platform Study (the “Platform Study IND”) in accordance with the Platform Study Protocol. GSK shall own the Platform Study IND. As between the Parties, GSK shall have the sole right and authority to make and submit filings regarding the Sub-Study to the Platform Study IND. 4.6 GSK shall prepare the global template patient informed consent form for the Clinical Studies (which shall include provisions designed to permit the lawful sharing of Samples and Licensed Clinical Data and the use of Samples in Sample Testing) in accordance with Applicable Law and in consultation with SpringWorks and shall consider SpringWorks’ comments in good faith; provided that SpringWorks shall control the contents of, and provide to GSK, the portion of the informed consent form relating to the SpringWorks Compound, which shall be prepared in accordance with Applicable Law and in respect of which SpringWorks shall consult with GSK and consider all comments of GSK shall in good faith. 4.7 No less than [***] days prior to each meeting of the JDC (in accordance with Section 6.2), GSK shall provide the JDC with reasonably detailed written reports summarizing the material Development activities performed by GSK since the preceding report, its material Development activities in process, and the future material Development activities it expects to initiate prior to the next report. Such reports would include other information as agreed by the JDC. Following any Change of Control of SpringWorks or an assignment of this Agreement by SpringWorks pursuant to Section 28 (iii) (an “Assignment”), in either case where the acquiror, successor, resulting entity or assignee (the “Resulting Entity”) following such Change of Control or Assignment, as applicable,[***]. 4.8 GSK shall provide to SpringWorks copies of all Licensed Clinical Data, in electronic form or other mutually agreeable alternate form following creation or compilation of such Licensed Clinical Data in accordance with the timelines set out in the applicable protocol for the relevant Clinical Study or otherwise on the timelines to be agreed by the JDC, provided that GSK has obtained all necessary consents required to lawfully share such Licensed Clinical Data and such Licensed Clinical Data is otherwise reasonably available without undue burden. GSK shall use Commercially Reasonable Efforts to obtain all patient authorizations and consents required under Data Protection Laws in connection with any Clinical Studies conducted under the Development Plan to permit such sharing of Licensed Clinical Data with SpringWorks. 4.9 Without limiting the requirements of or expanding the limitations of the foregoing Section 4.8, GSK shall provide SpringWorks with: (a) following such information becoming reasonably available to and being compiled by GSK in accordance with the timelines set out in the applicable protocol for the relevant Clinical Study, an electronic first draft of the clinical study report (“CSR”) for such Clinical Study in accordance with the results and analysis plan for such Clinical Study. SpringWorks shall review such first draft report and provide comments to GSK within GSK’s internal timeline for commenting on such draft,
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CONFIDENTIAL Page 18 number of representatives (but in any event, the JDC shall be made up of an equal number of representatives from each Party), which shall have responsibility for: (a) [***]; (b) [***]; (c) [***]; and (d) carrying out such other responsibilities as expressly delegated to the JDC as set forth in this Agreement or as may be mutually agreed by the Parties from time to time. 6.3 Either Party may propose, through the JDC or JCC, as applicable, potential alignment on a [***] for the Combination Regimens in the Field. If the Parties mutually agree that such [***] is desirable, the Parties shall use reasonable efforts to agree on the terms of such [***] which terms, if agreed between the Parties, shall be reflected in an amendment to this Agreement. 6.4 Within [***] of the Effective Date (or earlier if agreed by the Parties), the Parties shall establish a joint commercialization committee (the “JCC”) which shall be made up of an equal number of representatives from each Party and shall be responsible for: (a) [***]; (b) [***]; and (c) carrying out such other responsibilities as expressly delegated to the JCC as set forth in this Agreement or as may be mutually agreed by the Parties from time to time. 6.5 [***] 6.6 [***] 6.7 [***] 6.8 From time to time, a Committee may establish and delegate duties to other committees, subcommittees or directed teams (each, a “Working Group”) on an “as needed” basis to oversee particular projects or activities, which delegations shall be reflected in the minutes of the meetings of the respective Committee. Such Working Groups may be established on an ad hoc basis for purposes of a specific project, or on such other basis as the respective Committee may determine, and shall be constituted and shall operate as such Committee may determine; provided, that each Working Group shall have equal representation from each Party, and, subject to Sections Section 6.5, 6.6 and 6.7, decision-making shall be by consensus, with each Party’s representatives on the applicable Working Group collectively having one (1) vote on all matters brought before the Working Group. Each Working Group and its activities shall be subject to the direction, review and approval of, and shall report to, the respective Committee. In no event shall the authority of the Working Group exceed that specified for the Committees in this Article 6. 6.9 Each Party shall designate an alliance manager (the “Alliance Manager”) who shall be responsible for coordinating the activities of the Committees under this Agreement. Such
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CONFIDENTIAL Page 19 Alliance Managers will be responsible for the day-to-day worldwide coordination of the collaboration contemplated by this Agreement and will serve to facilitate communication between the Parties. The Alliance Managers shall attend meetings of the Committees but shall not be counted as members of the Committees (and shall not vote on matters discussed at any such Committee meetings). Each Party may change its designated Alliance Manager from time to time upon notice to the other Party. 6.10 Each Committee shall meet no less than [***], unless otherwise agreed by the relevant Committee. The Alliance Managers shall be responsible (on a rotating basis with the GSK Alliance Manager responsible for the first meeting of each Committee after the Effective Date) for arranging the date of the meetings of the Committees and shall circulate an agenda for each meeting at least [***] Business Days prior to the agreed date for the meeting. The other Party shall be entitled to comment on and add items to the agenda and re-circulate the agenda at least [***] Business Days ahead of the agreed date of the meeting. The Parties shall each be responsible for their own costs and expenses incurred in participating in and attending Committee meetings. The minutes of each Committee meeting will be drafted by the meeting’s secretary and shall summarize discussion highlights, actions, agreements and issues requiring escalation for resolution. The first such secretary shall be the GSK Alliance Manager and thereafter the secretarial appointment shall alternate between the SpringWorks Alliance Manager and the GSK Alliance Manager. The draft minutes shall be circulated within [***] Business Days of the relevant Committee meeting by the applicable Alliance Manager for review and comment. Such Alliance Manager shall circulate a final version of such minutes to the relevant Committee at least [***] Business Days in advance of the next Committee meeting for approval at such Committee meeting. 7. REGULATORY 7.1 If GSK files an application for Regulatory Approval for a GSK BCMA Product for use in the Combination Regimen in the Field in any country or region in the Commercialization Territory, then GSK shall use Commercially Reasonable Efforts to [***]. SpringWorks shall file an application for and use Commercially Reasonable Efforts to [***]. 7.2 If SpringWorks has not filed an application for Regulatory Approval for the SpringWorks Compound in [***]. 7.3 For the avoidance of doubt, SpringWorks shall own and retain all rights (other than as expressly stated in this Agreement) to the SpringWorks Regulatory Documentation and all Regulatory Documentation related solely to the SpringWorks Compound. 7.4 For the avoidance of doubt, GSK shall own and retain all rights (other than as expressly stated in this Agreement) to the GSK Regulatory Documentation, all Regulatory Documentation related solely to the GSK BCMA Products and the Study Regulatory Documentation. 7.5 Each Party hereby grants to the other Party and its Affiliates (including the right to sublicense to the Sublicensees and subcontractors) a Right of Reference to its Regulatory Documentation (including the appropriate INDs and CTAs) for the sole purpose of enabling the other Party, its Affiliates, Sublicensees and subcontractors to apply for and maintain any and all Regulatory Approvals required to conduct the activities assigned to such Party under the Development Plan and to Commercialize its Compound as part of the Combination Regimen in the Field in accordance with this Agreement. Each Party shall promptly provide to the other Party or its nominee and FDA or other Regulatory Authorities
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CONFIDENTIAL Page 20 in the Commercialization Territory all letters of authorization required to enable such Right of Reference. If either Party’s CTA is not available in a given country, such Party will file its CMC data with the Regulatory Authority for such country, referencing the other Party’s CTA as appropriate (however, the other Party shall have no right to directly access the CMC data). 7.6 As required by Applicable Law or a Regulatory Authority and otherwise upon a Party’s reasonable request (the “Requesting Party”), the other Party shall reasonably cooperate with the Requesting Party, in the preparation, submission and prosecution of Regulatory Documentation to, and responding to queries from, Regulatory Authorities, in connection with the Requesting Party’s Regulatory Approval, activities under the Development Plan and Commercialization of its Compound as part of the Combination Regimen in the Field in the Commercialization Territory. For the avoidance of doubt, nothing herein will require either Party to convey any rights to Regulatory Documentation relevant to its Compound with any compound or substance other than as part of a Combination Regimen in the Field. 7.7 Without prejudice to Section 7.5, and subject to Section 8.4, each Party shall take such actions as are reasonably necessary to enable the other Party to reference Licensed Clinical Data and its Compound in its own product labelling [***], to support use and Commercialization of the other Party’s Compound as part of the Combination Regimen in the Field. 7.8 [***]. Each Party shall provide the other Party with copies of all such applications for Regulatory Approval, material reports and material correspondence with Regulatory Authorities to the extent pertaining to the Combination Regimen in the Field (but not the providing Party’s Compound alone) which each Party shall use commercially reasonable efforts to provide at least [***] Business Days in advance unless circumstances necessitate a shorter time period, and in any event not less than a reasonable time in advance under the circumstances. Following any Change of Control of SpringWorks or an Assignment, in either case where the Resulting Entity or any Affiliate of the Resulting Entity is then Developing or Commercializing a BCMA-directed therapy in the Field, [***]. 7.9 As required by Applicable Law or a Regulatory Authority and otherwise upon a Party’s reasonable request, the other Party shall reasonably cooperate with the Requesting Party in good faith in support of the Requesting Party’s submissions to or interactions with Regulatory Authorities related to the Combination Regimen in the Field or the activities carried out under the Development Plan, including by participating in [***]. 8. COMMERCIALIZATION 8.1 Each Party shall remain solely responsible for Commercialization of its Compound for all purposes, including as part of the Combination Regimen in the Field. Unless otherwise agreed by the JCC, each Party shall make available its Compound in the applicable form, formulation and dosage strength as set out in the applicable Regulatory Approval for the applicable Combination Regimen in the Field in each country or region in the Commercialization Territory, and shall use Commercially Reasonable Efforts to meet the timelines agreed by the Parties for such availability. 8.2 SpringWorks shall ensure that the SpringWorks Compound is made available in quantities required to meet the commercial forecasts [***] and shall use Commercially Reasonable Efforts to make available any required amounts [***]. If, at any time during the Term, (a) SpringWorks does not have the ability or otherwise fails, itself or through a Third Party, to
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CONFIDENTIAL Page 23 responsible for obtaining all approvals (including facility licenses) that are required by the applicable Regulatory Authority to Manufacture the SpringWorks Compound in accordance with Applicable Law. 12.2 SpringWorks shall establish or maintain, as applicable, a primary source of Manufacturing capacity, and a back-up source of Manufacturing with capacity to supply the total anticipated requirements of the SpringWorks Compound for Development and agreed commercial forecasts. As of the Effective Date, the Parties acknowledge that such back-up source is presently intended to be the party(ies) specified in Schedule 12.2. SpringWorks shall not change its primary source or the foregoing back-up source of Manufacturing the SpringWorks Compound during the Term without advance notification to GSK and shall take into account any good faith concerns raised by GSK with respect to any such alternative supplier. 12.3 SpringWorks shall supply, or cause to be supplied, at its sole cost and expense, cGMP- grade quantities of SpringWorks Compound for use in the activities to be conducted by GSK under the Development Plan (including the Sub-Study), in the quantities and on the timelines set forth on Appendix A (in relation to the Sub-Study) or as otherwise established by the JDC, and in accordance with the terms of this Article 12. In the event that GSK determines that the quantities of the SpringWorks Compound set forth on Appendix A (in relation to the Sub-Study) or otherwise in the forecast established by the JDC are not sufficient to complete the activities to be conducted by GSK under the Development Plan, GSK shall notify SpringWorks, and the Parties shall agree in good faith on, such additional quantities of SpringWorks Compound to be provided to GSK to complete the activities to be conducted by GSK under the Development Plan and the schedule on which such additional quantities shall be provided. SpringWorks shall use Commercially Reasonable Efforts to supply, at its sole cost and expense, such agreed-upon quantities of SpringWorks Compound. Each Party shall notify the other Party promptly, and the JDC shall discuss, in the event of any Manufacturing or supply issues, including any delay in supply of its Compound, that is reasonably likely to adversely affect the conduct or timelines of the activities under the Development Plan. SpringWorks shall, within [***] days of the Effective Date, provide to GSK the name and contact details of a person responsible for assisting with coordinating, and facilitating the resolution of any issues or concerns arising in connection with the supply of the SpringWorks Compound under this Agreement. SpringWorks shall ensure that all activities conducted by SpringWorks, its Affiliates and its permitted (sub)contractors and Sublicensees under this Article 12 are conducted in compliance with cGMP, GCP and other Applicable Law and the Clinical Quality Agreement and applicable safety and environmental protocols. 12.4 Without limiting its other obligations hereunder and without prejudice to Section 8.2, in the event of a shortage of the SpringWorks Compound such that SpringWorks reasonably believes that it will not be able to fulfil its supply obligations hereunder with respect to the SpringWorks Compound for use in the activities to be conducted under the Development Plan, SpringWorks will provide prompt written notice to GSK thereof (including the reason for the shortage and the quantity of the SpringWorks Compound that SpringWorks reasonably determines it will be able to supply) and, upon request, the JDC will promptly discuss such situation in good faith. 12.5 Each Party shall be responsible for Manufacturing, at its own cost, commercial supply of its Compound for the Commercialization Territory following Regulatory Approval in such Commercialization Territory. SpringWorks shall supply the forecasted amounts of commercial supply of the SpringWorks Compound as agreed by the JCC; provided that if
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CONFIDENTIAL Page 24 the quantities of the SpringWorks Compound set forth in the forecasts established by the JCC are not sufficient to meet commercial demand in any part of the Commercialization Territory, the Parties, through the JCC, shall discuss and agree upon the allocation of additional quantities of SpringWorks Compound to meet such excess demand and the schedule on which such additional quantities shall be provided. SpringWorks shall use Commercially Reasonable Efforts to supply, at its sole cost and expense, such agreed-upon quantities of SpringWorks Compound to meet such excess demand. 12.6 Minimum Shelf Life Requirements. SpringWorks shall supply the SpringWorks Compound for use in the activities to be conducted by GSK under the Development Plan with an adequate remaining shelf life at the time of Delivery to meet the requirements under the Development Plan. 12.7 Delivery of Compounds. (a) SpringWorks will deliver, at its sole cost, the SpringWorks Compound for use in the activities to be conducted by GSK under the Development Plan [***] (INCOTERMS 2020) to GSK’s, or its designee’s location as specified by GSK (“Delivery” with respect to such SpringWorks Compound). Title and risk of loss for the SpringWorks Compound shall transfer from SpringWorks to GSK at Delivery. All costs associated with the subsequent transportation, warehousing and distribution to Clinical Study sites of SpringWorks Compound after Delivery takes place shall be borne by GSK. For the avoidance of doubt, if prior to Delivery the SpringWorks Compound for any reason or in any way becomes lost, damaged, destroyed or becomes unable to comply with applicable Specifications, SpringWorks shall be obligated to replace the same at its sole cost and shall use Commercially Reasonable Efforts to do so as soon as practicable in order to cause the least disturbance to the conduct and timelines of the activities under the Development Plan. (b) GSK is solely responsible, at its sole cost, for supplying (including all Manufacturing, acceptance and release testing) the GSK BCMA Products for the activities under the Development Plan, and the subsequent handling, storage, transportation, warehousing and subsequent distribution of the GSK BCMA Products supplied hereunder. 12.8 Labelling and Packaging; Use of SpringWorks Compound. The Parties’ obligations with respect to the labelling and packaging of the GSK BCMA Products and the SpringWorks Compound are as set forth in the Clinical Quality Agreement. Notwithstanding the foregoing or anything to the contrary contained herein, unless otherwise agreed between the Parties, SpringWorks shall supply the SpringWorks Compound for use in the activities to be conducted by GSK under the Development Plan to GSK in the form of unlabelled, [***], and GSK shall be responsible for labelling and packaging such bottles for use in the activities under the Development Plan. 12.9 Product Specifications. A certificate of analysis, and such other documentation as may be agreed to by the Parties and set forth in the Clinical Quality Agreement, shall accompany each shipment of the SpringWorks Compound to GSK in accordance with the terms of the Clinical Quality Agreement. SpringWorks shall be responsible for any failure of the SpringWorks Compound to meet the Specifications and shall replace any such SpringWorks Compound free of charge; provided that, to the extent that such failure is caused by GSK’s negligence or intentional misconduct in the shipping, storage or handling
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CONFIDENTIAL Page 28 governmental authority, (a) shall be treated for all purposes of this Agreement as having been paid to SpringWorks, and (b) will be an expense of and borne by SpringWorks. 13.8 SpringWorks warrants that SpringWorks is resident for tax purposes in the United States of America and that SpringWorks is entitled to relief from United Kingdom income tax under the terms of the double tax agreement between the United Kingdom and the United States of America. SpringWorks shall notify GSK immediately in writing if SpringWorks ceases to be entitled to such relief. 13.9 Pending receipt of formal certification from the UK Tax Authority, GSK may pay milestones under this Agreement to SpringWorks by deducting Tax at a rate specified in the double tax treaty between the United Kingdom and the United States of America. SpringWorks agrees to indemnify and hold harmless GSK against any loss, damage, expense or liability arising in any way from a breach of the warranty set forth in Section 13.8 or any future claim by a UK Tax Authority or other similar body alleging that GSK was not entitled to deduct withholding Tax on such payments at source at the treaty rate. 13.10 Notwithstanding anything to the contrary in this Agreement, in the event that a Party redomiciles or assigns its rights or obligations in accordance with Section 28 (each, a “Tax Action”), and as a result of such Tax Action the amount of Tax required to be withheld under Section 13.6 in respect of a payment to another Party is greater than the amount of such Tax that would have been required to be withheld or paid absent such Tax Action, then any such amount payable shall be increased to take into account such withholding Taxes as may be necessary so that, after making all required withholdings (including withholdings on the additional amounts payable), the Party receiving such payment receives an amount equal to the sum it would have received had no such increased withholding been made. The obligation to pay additional amounts pursuant to the preceding sentence shall not apply to the extent such increased withholding Tax (i) would not have been imposed but for a Tax Action taken by the Party eligible to receive additional amounts pursuant to the preceding sentence, or (ii) are attributable to the failure by the Party receiving a payment to comply with the requirements of Section 13.11. For purposes of this Section 13.10, a “redomiciliation” shall include a reincorporation or other action resulting in a change in tax residence of the applicable Party or its assignee. 13.11 The Parties will cooperate with respect to all documentation required by any applicable Tax Authority or reasonably requested by either Party to secure a reduction in the rate of applicable withholding Taxes. 13.12 Nothing contained in this Agreement shall be deemed or construed by the Parties or any of their Affiliates, or any third person to treat the relationship between the Parties contemplated by this Agreement as a partnership, joint venture or other business entity under Treasury Regulations Section 301.7701-1(a)(2) (or any corresponding provision under state, local or non-U.S. tax Applicable Law) (an “Entity”). Without the prior written consent of the Parties (such consent not to be unreasonably withheld, delayed or conditioned), no Party (or successor or assignee) shall, for Tax purposes, report the relationships established by this Agreement as an Entity, including either (a) making any disclosure that the relationships established by this Agreement may give rise to an Entity (whether on a U.S. Internal Revenue Service Form 8275 or otherwise) or (b) withholding any amounts from payments made to the other Party pursuant to Section 1446 of the Code (or any corresponding provision under state, local or non-U.S. tax Applicable Law), unless required by a tax authority on audit or other examination.
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CONFIDENTIAL Page 32 providing additional information, with any and all reasonable costs incurred by the Disclosing Party arising from such support to be borne by the Receiving Party. 15.2 Independent Data Controllers. To the extent applicable, the Receiving Party and the Disclosing Party agree that (to the extent that any Personal Data is disclosed to the Receiving Party), for the purposes of Data Protection Law, each of the Receiving Party and the Disclosing Party is an independent data controller. 15.3 Fair Processing Notices. The Disclosing Party represents and warrants that (to the extent that any Personal Data is disclosed to the Receiving Party): (i) it has the authority to provide the Personal Data to the Receiving Party; and (ii) it has taken, and shall take, all steps necessary, including providing all required fair processing notices to Data Subjects and, if necessary, obtaining any consent required from Data Subjects, to ensure that the provision of Personal Data to, and Processing by, the Receiving Party as envisaged under, and for the purposes specified in, the Agreement is in accordance with the European Data Protection Laws where applicable. The Receiving Party further agrees that the Disclosing Party (to the extent that any Personal Data is disclosed to the Receiving Party) may delay the disclosure of specific Personal Data to the Receiving Party until the Disclosing Party has provided such additional fair processing information to Data Subjects in relation to the Receiving Party’s processing of such Personal Data or taken such other actions as the Disclosing Party reasonably believes to be required by Data Protection Law to enable the Disclosing Party to comply with its obligations thereunder. If a Party reasonably believes that additional fair processing information or actions are required to ensure either Party’s compliance with Data Protection Law from time to time, such Party shall notify the other Party and the Parties shall discuss in good faith what action, if any, is required to be taken; provided, that the Receiving Party agrees that, as between the Parties, the Disclosing Party shall have the sole right (but not the obligation) to communicate or procure the communication of fair processing information (including updating such fair processing information) to Data Subjects, in a manner and form to be reasonably determined by the Disclosing Party in accordance with Data Protection Law, with any and all reasonable costs incurred by the Disclosing Party arising from such support to be borne by the Receiving Party. 15.4 Personal Data Transfers. Other than to countries approved, from time to time, as having equivalent protection for Personal Data as under European Data Protection Laws by the European Commission or, as applicable, the UK government, to the extent that any Personal Data is disclosed to the Receiving Party, the Receiving Party shall not process such Personal Data outside the EEA or the UK unless the Receiving Party complies with the data importer’s obligations set out in the Standard Contractual Clauses which are hereby incorporated into and form part of this Agreement (and if applicable, for the purposes of Annex I.A of the Standard Contractual Clauses, the Disclosing Party is a data controller and the Receiving Party is a data controller, and the name, address, contact person’s details and relevant activities for each of them is as set out in this Agreement, and for the purposes of Annex B/ I.B of such Standard Contractual Clauses, the Data Subjects, purpose of transfer, categories of data, recipients and categories of sensitive personal data shall be as set out in Sections 15.5 to 15.10 below). 15.5 Nature and Purpose of Sharing. To the extent that any Personal Data is disclosed to the Receiving Party on a controller to controller basis, such disclosure is solely for the purpose of carrying out activities under the Development Plan in accordance with the terms of this Agreement and Applicable Laws, including the Manufacture of each Compound, and obtaining Regulatory Approval of the Combination Regimens in the Field. The sharing of
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CONFIDENTIAL Page 33 the Personal Data is necessary for the purpose of the legitimate interests pursued by the Parties in Developing the Combination Regimens in the Field as contemplated by this Agreement. 15.6 Categories of Recipients. The Personal Data may only be onward transferred by the Receiving Party as permitted by and on the terms of this Agreement. 15.7 Duration of Sharing. As set out in this Agreement. The transfer is a continuous transfer. 15.8 Types of Personal Data Shared. The Personal Data may include: (a) identification information, such as name, address, contact information and qualifications, relating to each Party’s personnel and those working on such Party’s behalf in connection with the Development of the Combination Regimens by the Parties in connection with this Agreement; (b) patient identifiers, date of birth, age, relating to each subject participating in any Clinical Studies under the Development Plan; and (c) identification information, such as name, address, contact information and qualifications on healthcare professionals and investigators involved in any Clinical Studies under the Development Plan. 15.9 Special Category Personal Data Shared. The Personal Data will include special categories of Personal Data, including medical records, ethnic or racial background, test results, results of physical examinations, samples, adverse effects and any other health information. 15.10 Categories of Data Subjects. The Personal Data will relate to Data Subjects including: (i) each Party’s personnel and those working on such Party’s behalf in connection with the Development of the Combination Regimens; (ii) healthcare professionals and investigators involved in any Clinical Studies under the Development Plan; (iii) study subjects and patients; and (iv) end users of the Compounds. 15.11 Data Minimization. Each Party acknowledges that each Party is under an obligation to ensure that the Personal Data they process and which the Disclosing Party discloses is limited to only that which is necessary for the purposes of the processing, therefore the Disclosing Party shall (to the extent that any Personal Data is disclosed to the Receiving Party), notwithstanding any other provision of this Agreement, transfer only that Personal Data which is required to facilitate the performance of this Agreement. If the Receiving Party reasonably believes that additional Personal Data is required to be disclosed to enable the performance of this Agreement, the Receiving Party shall notify the Disclosing Party and the Parties shall discuss in good faith whether such additional Personal Data will be disclosed by the Disclosing Party, taking into account the Disclosing Party’s obligations under applicable European Data Protection Laws, the potential for the provision of anonymized data in place of the requested Personal Data, and any actions which are required to be taken by either Party in connection with such requested disclosure. 15.12 Receiving Party Obligations. The Receiving Party shall, and shall cause its officers, employees, agents, attorneys, consultants, advisors and other representatives to: (a) process any Personal Data in accordance with Data Protection Law and solely for the purposes disclosed and purposes compatible under applicable Data Protection
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CONFIDENTIAL Page 36 Owned Study Invention”) shall be owned jointly by GSK and SpringWorks. [***]. Each Party hereby assigns to the other Party a one-half, undivided interest under its right, title and interest in, to and under Jointly Owned Study Inventions. Subject to Article 14, GSK and SpringWorks shall each be entitled to exploit the Jointly Owned Study Inventions without accounting or financial payment to the other Party and without the consent of the other Party. For the avoidance of doubt, this right does not apply to Licensed Clinical Data which is subject to Section 16.3. For those countries where a specific license is required for a joint owner of a Jointly Owned Study Invention to practice such Jointly Owned Study Invention in such countries, (i) SpringWorks hereby grants to GSK a perpetual, irrevocable, non- exclusive, worldwide, royalty-free, fully paid-up license under SpringWorks’ right, title and interest in and to all Jointly Owned Study Inventions to use such Jointly Owned Study Inventions subject to and in accordance with the terms and conditions of this Agreement including Article 14, and (ii) GSK hereby grants to SpringWorks a perpetual, irrevocable, non-exclusive, worldwide, royalty-free, fully paid-up license under GSK’s right, title and interest in and to all Jointly Owned Study Inventions to use such Jointly Owned Study Inventions in accordance with the terms and conditions of this Agreement including Article 14. (b) Promptly following the Effective Date, but in any event as soon as practicable after the discovery of a Jointly Owned Study Invention, patent representatives of each of the Parties shall meet (in person or by telephone) to discuss the patenting strategy for such Jointly Owned Study Inventions. In particular, the Parties shall discuss which Party will file a patent application (including any provisional, substitution, divisional, continuation, continuation in part, reissue, renewal, re-examination, extension, supplementary protection certificate and the like) in respect of any Jointly Owned Study Invention (each, a “Joint Patent Application”), and in which territories such patent applications will be filed. The Parties shall appoint patent counsel that is mutually acceptable to both Parties with respect to filing, prosecuting, and maintaining Joint Patent Applications and Joint Patents. The Parties shall consult and reasonably cooperate with one another in the preparation, filing, prosecution (including prosecution strategy) and maintenance of such patent application; provided, however, that GSK shall have final say in patenting strategy and prosecution of any Joint Patent Application. Costs of filing, prosecuting, and maintaining Joint Patent Applications and Joint Patents and any associated expenses shall be divided equally by the Parties (50/50). Neither Party will be obligated for costs, or any portion thereof, for filing, prosecuting, and maintaining Joint Patent Applications and Joint Patents in other jurisdictions without prior agreement by the Parties; provided, however, that in the event that a Party does not agree to share equally the costs for filing, prosecuting, and maintaining a Joint Patent Application in a particular jurisdiction, such Party shall not have any rights to (i) enforce any Joint Patent arising from such Joint Patent Application in such jurisdiction or (ii) share in any revenues received by the other Party from the enforcement or license of any such Joint Patent or Joint Patent Application. If one Party (the “Filing Party”) wishes to file a particular Joint Patent Application for a Jointly Owned Study Invention and the other Party (the “Non-Filing Party”) does not want to file a particular Joint Patent Application for such Jointly Owned Study Invention or does not want to file in a particular country, then the Non-Filing Party shall assign its undivided half-interest in such Jointly Owned Study Invention to the Filing Party and shall execute in a timely manner and at the Filing Party’s reasonable expense a power of attorney and any additional documents (in such country or all countries, as applicable) as may be reasonably necessary to give
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CONFIDENTIAL Page 37 effect to the assignment and allow the Filing Party to file and prosecute such Joint Patent Application, and the Non-Filing Party shall cease to have payment obligations or any rights in relation thereto. If a Party (the “Opting-out Party”) wishes to discontinue the prosecution and maintenance of a Joint Patent Application or Joint Patent (in one or more countries), the other Party, at its sole option (the “Continuing Party”), may continue such prosecution and maintenance. In such event, the Opting-out Party shall assign its undivided half- interest in such Joint Patent Application and any Joint Patents issuing therefrom to the Continuing Party, and execute in a timely manner and at the Continuing Party’s reasonable expense a power of attorney and any additional documents (in such country or all countries, as applicable) as may be necessary to give effect to the assignment and allow the Continuing Party to prosecute and maintain such Joint Patent Application or Joint Patent, and the Opting-Out Party shall cease to have payment obligations or any rights in relation thereto. (c) Each Party will promptly notify the other Party of any actual, threatened, alleged or suspected infringement by a Third Party of the GSK IPR, SpringWorks IPR or Joint Patents by reason of the Development or Commercialization of the Combination Regimen. GSK shall have the first right, at its sole expense, to initiate legal action to enforce all Joint Patents against infringement by any Third Party where such infringement results from the Development or Commercialization of either (i) a GSK-Related Compound, but not a SpringWorks-Related Compound or (ii) a Combination Regimen, or to defend any declaratory judgment action relating to the foregoing. If GSK fails to initiate or defend such action within [***] days after being first notified of such infringement, or [***] days before the expiration of any time limit which confers a benefit in connection with such action set forth in an Applicable Law or regulation (including the time limits set forth under the Xxxxx-Xxxxxx Act (21 U.S.C. § 355)) for filing such action or responding, whichever comes first, then SpringWorks shall have the right to do so solely with respect to the Combination Regimen and not a GSK-Related Compound, at its sole expense; provided that GSK will coordinate with respect to, and keep SpringWorks informed of, such infringement and any settlement thereto or defense of any declaratory judgment action. SpringWorks shall have the first right to initiate legal action to enforce all Joint Patents against infringement by any Third Party where such infringement results from the Development or Commercialization of a SpringWorks-Related Compound, but not a GSK-Related Compound, or to defend any declaratory judgment action relating thereto, at its sole expense. If SpringWorks fails to initiate or defend such action within [***] days after being first notified of such infringement, or [***] days before the expiration of any time limit which confers a benefit in connection with such action set forth in an Applicable Law or regulation (including the time limits set forth under the Xxxxx-Xxxxxx Act (21 U.S.C. § 355)) for filing such action or responding, whichever comes first, then GSK shall have the right to do so at its sole expense. (d) If one Party brings any prosecution or enforcement action or proceeding against a Third Party with respect to any Joint Patent, the second Party agrees to be joined as a party plaintiff where necessary and to give the first Party reasonable assistance and authority to file and prosecute the suit. The costs and expenses of the Party bringing suit under this Section 17.4(d) shall be borne by such Party, and any damages or other monetary awards recovered shall be shared as follows: (i) the amount of such recovery actually received by the Party controlling such action shall
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CONFIDENTIAL Page 41 Inc., Pfizer Products Inc. and SpringWorks Therapeutics, Inc., dated July 31, 2019 (the “Pfizer Agreement”) (including any amendments thereof), except that portions of such agreement may have been redacted that do not pertain to the SpringWorks Compound or that would not otherwise reasonably impact GSK’s ability to Develop the Combination Regimen in the Field or Commercialize GSK BCMA Products as part of the Combination Regimen in the Field. SpringWorks is not aware of any material breach of the Pfizer Agreement that would give Pfizer Inc. or Pfizer Products Inc. or any of their Affiliates the right to terminate the same. 20.10 Each Party hereby represents and warrants that it has not employed or otherwise used in any capacity and will not employ or otherwise use in any capacity, the services of any person that has been Debarred in performing any activities under this Agreement or the Related Agreements and that this warranty may be relied upon in any applications to a Regulatory Authority. It is understood and agreed that this warranty imposes a continuing obligation on each Party to notify the other in writing immediately if any such Debarment occurs or comes to its attention, and each Party shall, with respect to any person so Debarred, promptly remove such person from performing in any capacity related to activities under this Agreement or the Related Agreements. 20.11 GSK DOES NOT UNDERTAKE THAT THE ACTIVITIES UNDER THE DEVELOPMENT PLAN SHALL LEAD TO ANY PARTICULAR RESULT, NOR IS THE SUCCESS OF SUCH ACTIVITIES GUARANTEED. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY USE THAT THE OTHER PARTY MAY MAKE OF THE LICENSED CLINICAL DATA NOR FOR ADVICE OR INFORMATION GIVEN IN CONNECTION THEREWITH. 20.12 EXCEPT AS EXPRESSLY PROVIDED IN THIS ARTICLE 20, NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, WITH RESPECT TO ITS COMPOUND. 21. ANTI-CORRUPTION 21.1 Each Party agrees that it: (a) shall comply at all times with Applicable Law; (b) has not, and covenants that it shall not, in connection with the performance of this Agreement, directly or indirectly make, promise, authorize, ratify or offer to make, or request, receive, or agree to receive or take any act in furtherance of, any payment or transfer of anything of value (i) for the purpose of influencing, inducing or rewarding any act, omission or decision to secure an improper advantage; (ii) for the purpose of improperly assisting it in obtaining or retaining business; or (iii) with the purpose or effect of committing an act of bribery; and (c) warrants that it has taken reasonable measures to prevent subcontractors, agents or any other Third Parties subject to its control or determining influence from committing any of the acts described in Section 21.1(b), and for the avoidance of doubt, the activities described above shall include facilitating payments which are unofficial or improper and small payments or gifts offered or made to Government Officials to secure or expedite a routine or necessary action.
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CONFIDENTIAL Page 42 21.2 Except as required by Applicable Law, or in the ordinary course of business, including audits and inspections of a Party’s facilities by Regulatory Authorities, each Party shall not contact, or otherwise knowingly meet with any Government Official for the purpose of discussing activities arising out of or in connection with this Agreement, without the prior written approval of the other Party and, when requested by the other Party, only in the presence of a designated representative of such other Party. 21.3 Each Party shall inform the other Party in writing, if, during the course of this Agreement, it is convicted of or pleads guilty to a criminal offence involving fraud or corruption, becomes the subject of any government investigation for such offenses, or is listed by any government agency as debarred, suspended, proposed for suspension or debarment, or otherwise ineligible for government programs. 21.4 SpringWorks represents and warrants that except as disclosed to GSK in writing prior to the commencement of this Agreement: (a) to its knowledge, none of their significant shareholders (>25% shareholding) or senior management have influence over GSK’s business; (b) to its knowledge, no significant shareholders (>25% shareholding), members of senior management team, members of the Board of Directors, or key individuals who will be responsible for the provision of goods / services, are currently or have been in the past [***] years a Government Official with actual or perceived influence which could affect GSK business; (c) it is not aware of any immediate relatives (e.g. spouse, parents, children or siblings) of the persons listed in the previous subsection (b) having a public or private role which involves making decisions which could affect GSK business or providing services or products to, or on behalf of GSK; (d) it does not have any other interest which directly or indirectly conflicts with its proper and ethical performance of this Agreement; and (e) it shall maintain arm’s length relations with all third parties with which it deals for or on behalf of GSK in performance of this Agreement. SpringWorks shall inform GSK in writing at the earliest possible opportunity of any conflict of interest as described in this Section 21.4 that arises during the performance of this Agreement. 21.5 GSK shall have the right [***] during the term of this Agreement to conduct an audit of SpringWorks’ books and records related to this Agreement solely as and to the extent reasonably required to monitor compliance with the terms of Article 21, provided that GSK shall be permitted to conduct more frequent audits to the extent GSK reasonably believes that SpringWorks is not complying with the terms of this Article 21 and further provided that such audits shall be conducted during normal business without unreasonable disruption to SpringWorks’ business. SpringWorks shall reasonably cooperate with such audit. The audit shall be conducted by an independent professional firm proposed by GSK and acceptable to SpringWorks. Before permitting such firm to have access to SpringWorks’ books and records, SpringWorks may require such firm and its personnel involved in such audit to sign a confidentiality agreement (save that such agreement will not prohibit transmission of information to GSK). 21.6 Each Party shall ensure that all transactions under the Agreement are properly and accurately recorded in all material respects on its books and records and each document upon which entries such books and records are based is complete and accurate in all material respects. Each Party must maintain a system of internal accounting controls reasonably designed to ensure that it maintains no off-the-books accounts. 21.7 Each Party agrees that in the event that a Party believes that there has been a possible violation of this Article 21, such Party may make full disclosure of such belief and related information at any time and for any reason to any competent government bodies and its
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CONFIDENTIAL Page 45 thereof from the non-breaching Party with respect to any other breach (or if a breach (other than a payment breach) is curable but cannot reasonably be cured within such [***] day period, then within such reasonable period thereafter as is required to cure such breach), then this Agreement shall terminate unless there is a good faith dispute with respect to the existence of a material breach or whether such material breach has been cured, and if such alleged breach or failure to cure is contested in good faith by the alleged breaching Party in writing within [***] days of the delivery of the breach notice, then the dispute resolution procedure pursuant to Section 30.2, may be initiated by either Party to determine whether a material breach or a failure to cure has actually occurred. If either Party so initiates the dispute resolution procedure, then the applicable cure period (and the corresponding termination of this Agreement, in whole or in part), shall be tolled until such time as the dispute is resolved pursuant to Section 30.2. 24.3 Either Party may terminate this Agreement if, at any time, the other Party files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such other Party or of such other Party’s assets, or if the other Party proposes a written agreement of composition or extension of its debts, or if the other Party shall be served with an involuntary petition against it, filed in any insolvency proceeding, and such petition shall not be dismissed or stayed within [***] days after the filing thereof, or if the other Party will propose or be a party to any dissolution or liquidation, or if the other Party shall make an assignment for the benefit of its creditors. 24.4 GSK may, upon [***] days’ prior written notice to SpringWorks, unilaterally terminate this Agreement without cause, in which event this Agreement shall remain in full force and effect until the effective date of such termination. 24.5 GSK may terminate this Agreement (in whole or in part on a country-by-country basis) immediately (after meeting and discussing with SpringWorks) upon written notice to SpringWorks if GSK determines in good faith, based on a review of the Clinical Data or other available information, that termination is necessary to protect the safety, health or welfare of subjects enrolled in any Clinical Study conducted under the Development Plan due to the existence of a Material Safety Issue. SpringWorks may terminate this Agreement (in whole or in part on a country-by-country basis) immediately (after meeting and discussing with GSK) upon written notice to GSK if SpringWorks determines in good faith, based on a review of the Clinical Data or other available information, that termination is necessary to protect the safety, health or welfare of subjects enrolled in any Clinical Study conducted under the Development Plan due to the existence of a Material Safety Issue with respect to the SpringWorks Compound and as a result of such Material Safety Issue SpringWorks is ceasing all development of the SpringWorks Compound in the Field, including development outside of this Agreement. In the event of a termination due to a Material Safety Issue, prior to provision of notice by the terminating Party, the Parties shall, to the extent practicable, meet and discuss in good faith the safety concerns raised by the terminating Party, but if any dispute arises in such discussion, the dispute resolution processes set forth in Article 30 shall not apply and the terminating Party shall have the right to issue such notice and such termination shall take effect. 24.6 If a Clinical Hold with respect to either the GSK BCMA Product or the SpringWorks Compound arises at any time during the Term, the Parties will meet and discuss the basis for the Clinical Hold, how long the Clinical Hold is expected to last, and how the issue that caused the Clinical Hold might be addressed. If, after [***] days of discussions following the Clinical Hold with respect to either Party’s Compound, either Party reasonably
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CONFIDENTIAL Page 47 possession or control pursuant to SpringWorks’ instructions, subject to GSK’s rights under Section 25.2(c)(ii)(B). If SpringWorks requests that GSK destroy the unused SpringWorks Compound, GSK shall provide written certification of such destruction and written notification of the quantity of SpringWorks Compound destroyed; and (B) the Parties shall use reasonable efforts to wind down activities under this Agreement in a reasonable manner, provided that (i) the Parties shall work together in good faith to ensure that each Party is able to comply with any ongoing regulatory or other obligations (including regulatory reporting obligations, clinical site and investigator communications) under Applicable Law relating to its Compound or the Combination Regimens, as the case may be, and (ii) GSK may continue to dose subjects enrolled in any Clinical Study conducted under the Development Plan through completion of such Clinical Study if dosing is required by the applicable Regulatory Authority(ies), ethical approvals, the applicable protocol or Applicable Law, in which case SpringWorks shall continue to supply SpringWorks Compound in accordance with Article 12 until such dosing is complete; and in each case (A) and (B) the provisions of Section 2 and Section 7.5 shall only survive for such period and to such extent as reasonably necessary to complete wind-down activities contemplated hereby. (d) In the event the effective date of termination is after [***]: (i) where GSK terminates under Sections 24.2 or Section 24.3, GSK’s rights under Section 2 and Section 7.5 shall continue and GSK’s remaining payment obligations under Sections 13.2-13.5 shall continue; provided that, if such termination was as a result of SpringWorks’ breach of Section 4.3, Section 7.1, Section 8.2 or Section 12.3, the amount of each of GSK’s remaining payment obligations under Sections 13.2-13.5 shall continue but shall be reduced by [***]%; and (ii) where the Agreement is terminated for any reason other than as set forth in subsection (i) directly above, GSK’s rights under Section 2 and Section 7.5 shall continue and all of GSK’s payment obligations under Sections 13.2- 13.5 shall continue pursuant to the terms of Sections 13.2-13.5. (e) Notwithstanding the foregoing, if this Agreement is terminated in part with respect to a particular country, then the effects of termination will be limited to such country. 25.3 The provisions of Sections 2.6 (Bankruptcy) and Articles 1 (Definitions), 14 (Confidentiality), 15 (Data Protection), 16 (Clinical Data Ownership & Use), 17 (Intellectual Property), 18 (Publications), 19 (Use of Name), 20 (Representations and Warranties; Disclaimers), 22 (Indemnification), 23 (Limitation of Liability), 25 (Effect of Expiry or Termination), 26 (Force Majeure), 27 (Entire Agreement; Modification), 28 (Assignment), 29 (Severability), 30 (Governing Law; Dispute Resolution and Jurisdiction),
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CONFIDENTIAL Page 49 attempted assignment by any Party in violation of the terms of this Article 28 shall be null and void and of no legal effect. 29. SEVERABILITY. If any provision of this Agreement is held to be illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect and will not be affected by the illegal, invalid or unenforceable provision. The illegal, invalid or unenforceable provision (or such part of such provision) shall be severed from this Agreement, and the Parties shall negotiate in good faith to agree upon a reasonable provision that is legal, valid and enforceable to carry out as nearly as practicable the original intention of the entire Agreement. 30. GOVERNING LAW, DISPUTE RESOLUTION AND JURISDICTION. 30.1 Governing Law. This Agreement shall be governed and construed in accordance with the substantive laws of the State of New York, without giving effect to its choice of law principles. 30.2 Dispute Resolution and Jurisdiction. (a) Subject to the other terms of this Agreement, the Parties agree that any dispute arising out of or relating to this Agreement (each, a “Dispute”) shall be resolved solely by means of the procedures set forth in this Section 30.2 prior to a Party exercising any other remedy permitted by this Agreement (other than seeking injunctive relief), and that such procedures constitute legally binding obligations that are an essential provision of this Agreement. If either Party fails to observe the procedures of this Section 30.2, the other Party may bring an action for specific performance of these procedures in any court of competent jurisdiction. (b) Negotiation. The Parties shall endeavor to resolve in good faith any Disputes arising from or relating to the subject matter of this Agreement, failing which either Party may submit such Dispute for resolution to appropriate senior management of SpringWorks and GSK. If such senior management representatives are unable to resolve such Dispute within [***] days after such conflict is submitted to them for resolution, either Party may refer the Dispute for mediation as set forth in Section 30.2(c). (c) Mediation. If the Parties are unable to resolve a Dispute arising out of or relating to this Agreement through the negotiation procedures set forth in Section 30.2(b), then at the end of such [***] day period, the Parties agree that they shall submit such Dispute for confidential mediation under the CPR Mediation Procedure then in effect at the start of mediation (the “CPR”). Unless otherwise agreed, the Parties shall select a mediator from the CPR panel of mediators. If the Parties cannot agree, they will defer to the CPR to select a mediator. The cost of the mediator shall be borne equally by the Parties. Any Dispute not resolved within [***] days (or within such other time period as may be agreed to by the Parties in writing) after appointment of a mediator shall be finally resolved by arbitration pursuant to Section 30.2(b). (d) Arbitration. If the Parties are unable to resolve a Dispute arising out of or relating to this Agreement through the negotiation procedures set forth in Section 30.2(b) and the mediation procedures set forth in Section 30.2(c) within the timeframes set
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CONFIDENTIAL Page 50 forth in such Sections, the Parties agree that they shall submit such Dispute for final settlement via binding arbitration. The arbitration shall be conducted under the Commercial Arbitration Rules of the American Arbitration Association in effect at the time of the arbitration, except as they may be modified herein or by mutual agreement of the Parties, but need not be under the auspices of the American Arbitration Association, and heard before a single arbitrator as selected in accordance with the Commercial Arbitration Rules. Such arbitration will be held in New York, New York and shall be conducted in English. Each Party shall be responsible for its own expenses in connection therewith; provided that, upon the rendering of the arbitration award, the non-prevailing party shall reimburse the prevailing Party for the arbitration fees. The Parties hereby submit to the non- exclusive jurisdiction of the United States District Court for the Southern District of New York for the limited purpose of enforcing this Agreement to arbitrate. The arbitration award shall be final and binding, and judgment over the award may be entered by any court having jurisdiction thereof or having jurisdiction over the relevant Party and its assets. (e) Confidentiality. The arbitration proceeding shall be confidential and the arbitrators shall issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by Applicable Law, no Party shall make (or instruct the arbitrators to make) any public announcement with respect to the proceedings or decision of the arbitrators without prior written consent of the other Party. The existence of any dispute submitted to arbitration, and any award shall be kept in confidence by the Parties and the arbitrators, except as required in connection with the enforcement of such award or as otherwise required by Applicable Law. Notwithstanding the foregoing, each Party shall have the right to disclose information regarding the arbitration proceeding to the same extent as it may disclose Confidential Information of the other Party under Article 13 above. (f) Patent Disputes. Notwithstanding the other provisions of this Section 30.2, any dispute, controversy or claim relating to the validity, scope, enforceability, inventorship, or ownership of intellectual property rights shall be submitted to a court of competent jurisdiction in the country in which such intellectual property rights were granted or arose. 30.3 Injunctive or Other Equitable Relief. Nothing contained in this Agreement shall deny either Party the right to seek injunctive or other equitable relief or interim or provisional relief from any court of competent jurisdiction, including a temporary restraining order, preliminary injunction or other interim equitable relief, concerning a dispute either prior to or during any arbitration if necessary in order to prevent irreparable harm, loss or damage, protect the interests of such Party or to preserve the status quo pending the arbitration proceeding, and such an action may be filed or maintained notwithstanding any ongoing discussions between the Parties. For the avoidance of doubt, the other Party shall have the right to seek injunctive or other equitable relief precluding the other Party from continuing its activities related to the Sub-Study without waiting for the conclusion of the dispute resolution procedures set out in this Article 30 if either Party (i) discloses Confidential Information of the other Party other than as permitted under this Agreement, (ii) uses the other Party’s Compound or Intellectual Property Rights in any manner other than as expressly permitted by this Agreement, or (iii) otherwise is in material breach of this Agreement and such material breach could cause immediate harm to the value of the GSK BCMA Product (if SpringWorks is in material breach) or the SpringWorks Compound (if GSK is in material breach).
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CONFIDENTIAL [SIGNATURE PAGE] SPRINGWORKS THERAPEUTICS, INC. By: /s/ Saqib Islam______________________ Name: Xxxxx Xxxxx Title: Chief Executive Officer
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CONFIDENTIAL Schedule 3.1 INITIAL DEVELOPMENT PLAN [***]
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CONFIDENTIAL Schedule 12.2 SpringWorks Back-Up Supplier [***]
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CONFIDENTIAL Schedule 13.5 Invoicing and Bank Details Instructions [***]
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CONFIDENTIAL Appendix A SUPPLY OF COMPOUND [***]
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Appendix B PRESS RELEASE [See Attached]
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SpringWorks Announces Expansion of Global, Non-Exclusive Collaboration with GSK for Nirogacestat in Combination with Blenrep in Patients with Multiple Myeloma - SpringWorks to Receive $75 Million Equity Investment with Potential for an Additional $550 Million in Milestone Payments - - SpringWorks to Supply Nirogacestat for GSK’s Global Blenrep Development Program and to Make Nirogacestat Commercially Available in Markets where a Combination with Blenrep is Approved - - SpringWorks to Continue Retaining Full Global Commercial Rights to Nirogacestat - STAMFORD, Conn., [September 7], 2022 – SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that it has entered into an expanded global, non-exclusive license and collaboration agreement with GSK plc (LSE/NYSE: GSK) for nirogacestat, SpringWorks’ investigational oral gamma secretase inhibitor, in combination with Blenrep (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting B-cell maturation antigen (BCMA). Under the terms of the expanded agreement, SpringWorks will receive a $75 million equity investment from GSK, with shares of common stock priced at a premium to the 30-day volume-weighted average share price on [insert date]. SpringWorks will also be eligible to receive up to $550 million in additional payments based on reaching certain development and commercial milestones. SpringWorks will retain full commercial rights to nirogacestat and will be responsible for global commercialization of nirogacestat. “We are very pleased to expand our relationship with GSK to enable potential additional studies of Blenrep and nirogacestat,” said Xxxxx Xxxxx, Chief Executive Officer of SpringWorks. “Our goal is to maximize the clinical impact of nirogacestat as a potentiator of BCMA targeted therapies and today’s announcement advances our opportunity to serve patients with multiple myeloma across lines of therapy.” “We look forward to continuing our relationship with SpringWorks for the potential expanded development of Blenrep with nirogacestat and are encouraged by the early clinical data emerging from the combination,” said Xxxxxx X. Xxxxxxxx, M.D., X.Xx., Senior Vice President, Global Head of Oncology Development at GSK. “Blenrep in combination with novel therapies, such as nirogacestat, could prove to be an impactful therapeutic option for patients with multiple myeloma, as these combination regimens may further optimize the benefit-risk profile of Blenrep, especially in earlier lines of therapy.” SpringWorks and GSK first entered into a clinical trial collaboration and supply agreement in June 2019, later amended in October 2021, to cover the initial clinical development of nirogacestat in combination with Blenrep in patients with relapsed or refractory multiple myeloma. The new agreement expands the original collaboration to include the potential for continued development and commercialization of the combination of nirogacestat and Blenrep in earlier lines of treatment, including newly diagnosed multiple myeloma. SpringWorks and GSK will expand their previously established governance structures to add a new Joint Steering Committee and Joint Commercialization Committee to their existing Joint Development Committee. GSK will continue funding all development costs, except for those related to the supply of nirogacestat and certain expenses related to intellectual property rights. About SpringWorks Therapeutics
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SpringWorks is a clinical-stage biopharmaceutical company applying a precision medicine approach to acquiring, developing and commercializing life-changing medicines for patients living with severe rare diseases and cancer. SpringWorks has a differentiated targeted oncology pipeline spanning solid tumors and hematological cancers, including two potentially registrational clinical trials in rare tumor types as well as several programs addressing highly prevalent, genetically defined cancers. SpringWorks’ strategic approach and operational excellence in clinical development have enabled it to rapidly advance its two lead product candidates into late-stage clinical trials while simultaneously entering into multiple shared-value partnerships with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer. For more information, visit xxx.xxxxxxxxxxxxx.xxx and follow @SpringWorksTx on Twitter and LinkedIn. SpringWorks Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including, but not limited to, current beliefs, expectations and assumptions regarding our expanded global, non-exclusive clinical collaboration and license agreement with GSK plc, the future of our business, future plans and strategies, our development plans, our preclinical and clinical results, as well as relating to other future conditions. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,” “should” and “could,” and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the success and timing of our product development activities, including the initiation and completion of SpringWorks’ clinical trials, (ii) the fact that topline or interim data from clinical studies may not be predictive of the final or more detailed results of such study, or the results of other ongoing or future studies, (iii) the success and timing of our collaboration partners’ ongoing and planned clinical trials, (iv) the timing of our planned regulatory submissions and interactions, including the NDA for nirogacestat planned for the second half of 2022 and the timing and outcome of decisions made by the U.S. Food and Drug Administration (FDA) and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; (v) whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, (vi) our ability to obtain and maintain regulatory approval of any of our product candidates, (vii) our plans to research, discover and develop additional product candidates, (viii) our ability to enter into collaborations for the development of new product candidates, (ix) our ability to establish manufacturing capabilities, and our and our collaboration partners’ abilities to manufacture our product candidates and scale production, (x) our ability to meet any specific milestones set forth herein, (xi) our expectations regarding the anticipated benefits from our expanded global, non-exclusive clinical collaboration and license agreement with GSK plc and (xii) uncertainties and assumptions regarding the impact of the COVID-19 pandemic on SpringWorks’ business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information,
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future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks’ expectations and actual results, you should review the “Risk Factors” in Item 1A of Part I of SpringWorks’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2022, as well as discussions of potential risks, uncertainties and other important factors in SpringWorks’ subsequent filings. # # # Contacts: Xxx Xxxxxxx Vice President, Communications and Investor Relations Phone: 000-000-0000 Email: xxxxxxxx@xxxxxxxxxxxxx.xxx Xxxxxxxx Xxxxxx Xxxxxxx Director, Investor Relations Phone: 000-000-0000 Email: xxxxxxxx.xxxxxxx@xxxxxxxxxxxxx.xxx