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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 980 Great West Road, Brentford, Middlesex, TW8 9GS, England  (“GSK”) and SpringWorks Therapeutics, Inc., a Delaware corporation, having a place of  business at 100 Washington Blvd., 5th Floor, Stamford, CT 06902 (“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.  





 






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  





 






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.    





 






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 https://www.clinicalstudydatarequest.com/.  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  





 






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 (http://oig.hhs.gov/exclusions/authorities.asp); (b) identified  in the OIG List of Excluded Individuals/Entities (LEIE) database  (http://exclusions.oig.hhs.gov/) or listed as having an active exclusion in the System for  Award Management (http://www.sam.gov); 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  (http://www.fda.gov/ora/compliance_ref/debar/).  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 Act 2018 (“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  





 






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  





 






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  





 






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  





 






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  





 






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 [***].  





 






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  





 






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.  





 






CONFIDENTIAL       Page 13   1.132 “VAT” means any value added, sales, purchase, turnover or consumption tax as may be  applicable in any relevant jurisdiction, including but not limited to value added tax  chargeable under legislation implementing Council Directive 2006/112/EC.   1.133 “Working Group” has the meaning set forth in Section 6.8.  2. LICENSE GRANTS   2.1 Subject to the terms and conditions of this Agreement, SpringWorks hereby grants, and  shall cause its Affiliates as needed to grant, to GSK a non-exclusive, worldwide,  sublicensable (in accordance with Section 2.5) license under the SpringWorks IPR to [***].  For the avoidance of doubt, nothing herein provides GSK with any rights, title or interest  to or in or any license to any SpringWorks IPR, other than as expressly set out in this  Agreement, including any rights, title or interest to or in or any license to the use of the  SpringWorks Compound with any compound or substance other than as part of the  Combination Regimens.  2.2 Subject to the terms and conditions of this Agreement, SpringWorks reserves the right to  use the SpringWorks IPR to Develop, make, use, sell, offer for sale and import or otherwise  Commercialize, itself or with and through its Affiliates and any Third Parties, the  SpringWorks Compound, alone or in combination with any products.    2.3 Subject to the terms and conditions of this Agreement, GSK hereby grants, and shall cause  its Affiliates as needed to grant, to SpringWorks a non-exclusive, worldwide, sublicensable  (in accordance with Section 2.5) license under the GSK IPR solely [***]. For the avoidance  of doubt, nothing herein provides SpringWorks with any rights, title or interest to or in or  any license to any GSK IPR, other than as expressly set out in this Agreement, including  any rights, title or interest to or in or any license to the use of the GSK BCMA Products  with any compound or substance other than as part of the Combination Regimens.   2.4 Without prejudice to Section 2.5, each Party shall have the right to delegate or subcontract  any portion of its obligations hereunder to subcontractors, provided that SpringWorks’  right to so delegate or subcontract shall not extend to any Development activities assigned  to SpringWorks under the Development Plan except with GSK’s prior written consent, such  consent not to be unreasonably withheld, delayed or conditioned. Each Party shall remain  solely and fully liable for the performance of such subcontractors and shall ensure that its  subcontractors perform their obligations pursuant to the terms of this Agreement.    2.5 Each Party shall have the right to grant sublicenses, through multiple tiers, under the  foregoing license grants in Sections 2.1 and 2.3 (individually, a “Sublicense”) to its  Affiliates and Third Parties without consent, provided that in each case (a) such Sublicense  is consistent with the terms and conditions of this Agreement and the rights granted to any  Sublicensee shall be subject and subordinate to the applicable terms and conditions of this  Agreement, (b) the Party granting a Sublicense shall be liable for all acts or omissions of  any Sublicensee that, if committed by the Party granting the Sublicense, would be a breach  of any of the provisions of this Agreement, (c) such Sublicense shall contain (i) a  requirement that the Sublicensee comply with the confidentiality and non-use provisions  of Section 14 and (ii) a requirement that the Sublicensee assigns rights to any Intellectual  Property Rights conceived, discovered, developed, reduced to practice or otherwise made  by such Sublicensee so that such rights can be conveyed in accordance with the terms and  conditions of this Agreement; and (d) SpringWorks’ right to grant a Sublicense under the  license grants in Section 2.3 shall not extend to any activities assigned to SpringWorks  





 






CONFIDENTIAL       Page 14   under the Development Plan, except in accordance with GSK’s prior written consent, such  consent not to be unreasonably withheld, delayed or conditioned.  2.6 All licenses granted by either Party to the other Party under this Agreement are deemed to  be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of rights to  “intellectual property” as defined in Section 101 of the U.S. Bankruptcy Code.  Each Party,  as licensee, may fully exercise all of its rights and elections under any applicable  Bankruptcy Code. The Parties further agree that, if a Party elects to retain its rights as a  licensee under any applicable Bankruptcy Code, such Party shall be entitled to complete  access to any technology licensed to it hereunder and all embodiments of such technology.   Such embodiments of the technology shall be delivered to such licensee Party not later  than: (a) the commencement of bankruptcy proceedings against the licensor Party, upon  written request, unless the licensor Party elects to perform its obligations under this  Agreement, or (b) if not delivered under clause (a), upon the rejection of this Agreement  by or on behalf of the licensor Party, upon written request.  Any agreements supplemental  hereto will be deemed to be “agreements supplementary to” this Agreement for purposes  of Section 365(n) of the U.S. Bankruptcy Code. As used herein, “Bankruptcy Code” means  the U.S. Bankruptcy Code and any foreign equivalent thereto in any country having  jurisdiction over a Party or its assets.  3. DEVELOPMENT PLAN; KNOW-HOW TRANSFER  3.1 An initial high level development plan agreed by the Parties is attached hereto as Schedule  3.1 that sets out the Clinical Studies (including the on-going Sub-Study) planned as of the  Effective Date to be conducted by GSK (the “Development Plan”). The Parties, acting  through the JDC and subject to Article 6, shall further update the Development Plan when  reasonable or required, including to address matters that cannot reasonably be addressed as  of the Effective Date, including anticipated timelines, patient numbers and the form,  formulation and dosage strength of the SpringWorks Compound required to conduct such  Clinical Studies. Either Party may propose additional updates and amendments to the  Development Plan at any time for consideration and approval by the JDC in accordance  with Section 6.2. The Development Plan will be used to forecast required amounts of  clinical supplies of the SpringWorks Compound in accordance with the process established  by the JDC; provided that initial forecasted supply for the Sub-Study is set forth on  Appendix A.    3.2 During the Term, the Parties will consider in good faith requests by investigators to conduct  investigator-sponsored studies or supported collaborative studies of the Combination  Regimen (alone or in combination with additional pharmaceutical agents) within the Field.  Each Party shall promptly inform the other of any such requests and the Parties will discuss  such requests through the JDC. Neither Party shall be obligated to approve or support any  such request; provided that such Party will inform the JDC of the reason for such decision.  In the event both Parties agree to support any such study, each Party shall use reasonable  efforts to supply reasonable quantities of its Compound to the extent reasonably available  for such study (e.g., each Party continues to manufacture its Compound subject to any  generally applicable shortage of its Compound and subject to other internal and Third Party  commitments of each Party with respect to the use and supply of its Compound). Such  supply will be pursuant to a separate agreement, which shall be negotiated in good faith  between the applicable Party(ies) and the investigator and/or the investigator’s institution,  as appropriate.  





 






CONFIDENTIAL       Page 15   3.3 SpringWorks will provide to GSK any Know-How and other data related to the  SpringWorks Compound requested by GSK from time-to-time during the Term, that is in  SpringWorks’ possession or control and that is required for the conduct of the activities  under the Development Plan or is reasonably necessary or useful for GSK in making any  decision relating to the Development of the Combination Regimen in the Field and the  maintenance of Regulatory Approvals therefor, whether generated by preclinical, CMC or  Clinical Studies or otherwise, (collectively, the “Know-How Transfers”).  The Know- How Transfers shall be requested and conducted in a timely manner, including to meet any  timelines set out in the Development Plan or regulatory requirements pertaining to the  conduct of the activities under the Development Plan and to enable GSK to draft and update  as necessary the investigator’s brochure for any Clinical Study conducted under the  Development Plan. The Know-How Transfers shall not apply to the extent SpringWorks’  compliance therewith would constitute a breach of an agreement between SpringWorks  and any Third Party: (a) which is entered into prior to the Effective Date; or (b) which is  entered into on or after the Effective Date, provided however that: (i) SpringWorks shall  use reasonable efforts to include a provision in such agreement that permits the sharing of  Know-How and data as set forth in this Section 3.3; and (ii) such carve out shall not apply  to the sharing of safety data in accordance with the Pharmacovigilance Agreement.  Any  dispute relating to this Section 3.3 shall be referred to, and promptly resolved in good faith  by, the JDC in accordance with Section 6.2.   4. CONDUCT OF THE DEVELOPMENT ACTIVITIES; REPORTING.  4.1 Each Party shall act in good faith and perform and fulfil its respective activities and  obligations under this Agreement in accordance with the terms of this Agreement and  Applicable Law. Notwithstanding anything to the contrary contained herein, neither GSK  nor SpringWorks shall employ, subcontract with or grant a Sublicense to any person or  entity that is Debarred or otherwise ineligible for government programs for the performance  of any activities under this Agreement or the Related Agreements.    4.2 Provided, SpringWorks complies with its obligations under Section 4.3, GSK shall use  Commercially Reasonable Efforts to Develop the Combination Regimens as set forth in  the Development Plan. Unless otherwise agreed between the Parties and reflected in the  Development Plan, GSK shall, subject to the applicable terms of this Agreement and any  Related Agreement, be solely responsible (as between the Parties) for the conduct of, and  be the sponsor of record for, the Clinical Studies contained in the Development Plan, and  manage and be responsible for the conduct of any other activities under the Development  Plan, including timelines and contingency planning, compiling, amending and filing all  necessary Study Regulatory Documentation with Regulatory Authorities pursuant to the  terms of this Article 4.   4.3 SpringWorks shall, at its own cost, conduct such Development activities as are necessary  to generate data (e.g., pharmacokinetic data or toxicology data)  related to the SpringWorks  Compound as a monotherapy where such data is reasonably necessary or required by a  Regulatory Authority (a) in order to enable GSK to conduct any activities under the  Development Plan on the timelines set out therein; or (b) in order for GSK to obtain any  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.  4.4 Notwithstanding anything to the contrary contained herein, GSK shall not be obligated to  undertake or continue any Development activities, and may terminate any ongoing Clinical  Study, if GSK reasonably determines that performance of such Development activity or  





 






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,  





 






CONFIDENTIAL       Page 17   which shall be communicated to SpringWorks when providing such draft and GSK  shall consider such comments in good faith;   (b) if applicable, following review of the first draft of the CSR pursuant to (a), any  subsequent draft reports to the extent that any information therein relating to the  SpringWorks Compound has changed or there has otherwise been a material  change since the first draft provided to SpringWorks, which SpringWorks shall  review and on which SpringWorks shall provide comments within GSK’s internal  timeline for commenting on such draft, as communicated to SpringWorks when  providing such draft which comments GSK shall consider such in good faith; and  (c) a final version of the CSR for the relevant Clinical Study no later than [***] months  following finalisation of such CSR by GSK, as applicable.  GSK shall not include  any statements in any final CSR solely relating to the SpringWorks Compound  which have not been approved by SpringWorks.   5. COSTS OF DEVELOPMENT.    5.1 The Parties agree that:  (a) all expenses in relation to the following provisions shall be borne or shared by the  Parties as provided in the relevant Articles or Sections set forth below:   (i) Manufacturing of the GSK BCMA Products and SpringWorks Compound,  according to Article 12; and   (ii) any costs associated with Intellectual Property Rights, according to Article  17;   (iii) costs associated with regulatory activities, in accordance with Section 7.9;  and  (b) each Party will pay any Third Party License Payment for which it is responsible if  required in connection with conduct of the activities under the Development Plan.  5.2 Subject to Section 5.1, unless otherwise agreed between the Parties and stated in the  Development Plan, GSK shall bear all other costs associated with the conduct of the  activities under the Development Plan.  6. GOVERNANCE  6.1 Within [***] days following the Effective Date, the Parties shall establish a joint steering  committee (the “JSC”), which shall be made up of an equal number of representatives from  each Party. The JSC shall initially be co-chaired by Dr. Badreddin Edris from SpringWorks  and a GSK VP  to be appointed and notified to SpringWorks within [***] days following  the Effective Date. The JSC shall (a) [***], (b) [***], (c) [***], and (d) carry out such other  responsibilities as expressly delegated to the JSC as set forth in this Agreement or as may  be mutually agreed by the Parties from time to time.   6.2 The Parties established a joint development committee under the Original Agreement,  which shall continue under this Agreement from the Effective Date (the “JDC”) in  accordance with the terms of this Article 6. The JDC will be made up of [***]  representatives of each of SpringWorks and GSK unless the Parties agree to a different  





 






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  





 






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  





 






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  





 






CONFIDENTIAL       Page 21   timely make available commercial supply of the SpringWorks Compound in a country in  the Commercialization Territory in amounts required to meet either the (i) then-current  demand in each such country or (ii) commercial forecasts for such countries [***], or (b)  either Party reasonably anticipates that SpringWorks will not have the ability to meet the  requirements described in (a) above, then SpringWorks (in the case of (a) above) or the  Party anticipating such inability (in the case of (b) above) shall promptly notify the other  Party in writing. Without prejudice to any other rights or remedies available to either Party  at law, equity or otherwise, following such notification, the JCC shall meet promptly, but  in any event within [***] Business Days of such notification, and discuss the development  of an operational plan to ensure sufficient supply of the SpringWorks Compound as  efficiently and rapidly as is reasonably possible under then-current circumstances (the  “Supply Remediation Plan”).  The initial Supply Remediation Plan shall be [***].   8.3 Without prejudice to Section 8.2, in the event of any shortage or inability to make available  commercial supply of the SpringWorks Compound in a country in the Commercialization  Territory in the amounts required to meet commercial forecasts [***], or the then-current  demand for the SpringWorks Compound in each such country, SpringWorks shall  equitably allocate supply to countries and shall not treat such supply in any manner less  favorable than SpringWorks treats supply of the SpringWorks Compound for other  purposes (with such allocation, following an appropriate ramp-up period, based primarily  on historical demand for the SpringWorks Compound in any such countries for which the  SpringWorks Compound has been made commercially available as part of the Combination  Regimen).  8.4 Each Party (or its Affiliates) shall own and shall be solely responsible for such Party’s  Compound Trademarks, including (a) registering, prosecuting, and enforcing such  Compound Trademarks and (b) investigating and defending any infringement or threatened  infringement relating to any such Compound Trademark. Neither Party shall have the right  to use any Compound Trademarks of the other Party, and each Party agrees that it and its  Affiliates shall not use, register, or attempt to register any Compound Trademark of the  other Party or any other mark so resembling any existing Compound Trademark of the  other Party as to be likely to cause confusion or deception. In Commercializing its  respective Compound as part of any Combination Regimen in the Field, each Party may  use the international non-proprietary name of the other Party’s Compound for the purposes  of labelling, promotional materials and educational materials.  Notwithstanding the  foregoing, in the event that the [***].    8.5 Each Party will be solely responsible for and pay any Third Party License Payments known  as of the Effective Date or arising during the Term, required solely in connection with the  Commercialization of such Party’s Compound. If, during the Term, a Party determines that  it is necessary or desirable to obtain rights under any Third Party’s Intellectual Property  Rights in order to Commercialize [***], such party may (but shall not be obligated to)  [***], nothing herein shall restrict a Party from [***].      9. SAMPLE TESTING.  9.1 GSK shall perform or have performed all Sample Testing and shall own all Samples and  Sample Testing Results.    9.2 GSK shall perform Sample Testing (a) of Biomarkers to the Sub-Study as set out in the  applicable protocol and, (b) in relation to other Clinical Studies conducted under the  Development Plan, as may be agreed between the Parties, acting through the JDC and  





 






CONFIDENTIAL       Page 22   subject to Section 6.5, during the Term of this Agreement (“Biomarker Testing”). The  JDC shall discuss in good faith whether GSK should [***].  GSK shall be responsible for  directing and overseeing the conduct of any Biomarker Testing (including as may be agreed  by the JDC). If a Party reasonably believes that a Biomarker discovered or developed by  SpringWorks may be relevant to a Clinical Study conducted under the Development Plan,  then the Parties shall, acting through the JDC and subject to Section 6.5, discuss and agree  [***] and [***]. Unless otherwise agreed and set out in the Development Plan, any agreed  Biomarker Testing shall be performed at GSK’s expense.  9.3 SpringWorks shall identify to GSK at the JDC its preferred vendor(s) for the conduct of  bioanalytical testing relating to pharmacokinetic Samples from subjects in any Clinical  Study conducted under the Development Plan, as provided in the relevant protocol for such  Clinical Study (the “Bioanalytical Testing”).  GSK shall use reasonable efforts to use such  preferred vendor(s) for the Bioanalytical Testing, provided that such vendor(s) are  approved in accordance with GSK’s internal due diligence processes and acceptable to  GSK’s procurement and/or third party resourcing functions, as applicable (“Approved  Vendor(s)”). [***]. Unless otherwise agreed and set out in the Development Plan, the  Bioanalytical Testing shall be conducted [***] and GSK shall be responsible for overseeing  the conduct of such testing by the Approved Vendor(s).  SpringWorks shall: (a) provide  the necessary authorization for the Approved Vendor(s) to conduct the Bioanalytical  Testing on behalf of GSK and for the delivery of the results of such testing to GSK so that  the results may be included in the CSR, and  (b) authorize the Approved Vendor(s) to  provide GSK with access to the validation report and method for the analysis of the  SpringWorks Compound, in the case of both (a) and (b), no later than [***] days following  the engagement of such Approved Vendor.    10. PHARMACOVIGILANCE AGREEMENT.   Within [***] days of the Effective Date, the Parties shall review the Pharmacovigilance  Agreement and, to the extent necessary, shall update and amend such Pharmacovigilance  Agreement to ensure the exchange of relevant safety data within appropriate timeframes  and in appropriate format to enable the Parties to fulfil local and international regulatory  reporting obligations and to facilitate appropriate safety reviews in relation to the activities  to be conducted under this Agreement.  In the event of a conflict between this Agreement  and the Pharmacovigilance Agreement, the terms of the Pharmacovigilance Agreement  shall control in relation to pharmacovigilance issues (including exchange of safety data)  only. The Parties may enter into new pharmacovigilance agreements as necessary or  desirable for each GSK BCMA Product.  11. CLINICAL QUALITY AGREEMENT.  Within [***] days of the Effective Date, the Parties shall review the Clinical Quality  Agreement and, to the extent necessary, shall update and amend such Clinical Quality  Agreement to cover activities to be conducted under this Agreement.  In the event of a  conflict between the terms of this Agreement and the terms of the Clinical Quality  Agreement, the terms of the Clinical Quality Agreement shall govern in respect of technical  quality issues only.    12. SUPPLY AND USE OF THE SPRINGWORKS COMPOUND.   12.1 SpringWorks agrees to Manufacture and supply the SpringWorks Compound for purposes  of the activities under the Development Plan as set forth in this Article 12. SpringWorks is  





 






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  





 






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  





 






CONFIDENTIAL       Page 25   conditions after Delivery to GSK hereunder, GSK shall pay the actual cost of such  replacement SpringWorks Compound without mark-up. For the purposes of the foregoing,  “actual cost” will be determined in accordance with SpringWorks’ accounting standards  used at the time such payment is made.   12.10 Changes to Manufacturing.  Subject to Section 12.2, each Party may make changes from  time to time to its Compound or the Manufacturing Site in accordance with the Clinical  Quality Agreement; provided that the intended changes would not require a submission,  amendment or variation to any IND in respect of the activities under the Development Plan,  and provided further that the Party making such change provides the other Party with prior  written notice of the intended changes, including any product and formulation changes and  associated impact assessment that may influence the clinical supply strategy and  management.  In the case of proposed changes to the Compound or the Manufacturing Site  which would require a submission, amendment or variation to any IND in respect of the  activities under the Development Plan, the Party proposing such change shall provide prior  written notice to the other Party of such intended changes, providing reasonable detail, and  the Party receiving such notice shall consider such request in good faith.   12.11 Product Testing; Noncompliance.  After Manufacturer’s Release of the SpringWorks  Compound but prior to shipment to GSK, SpringWorks shall provide GSK with such  certificates and documentation as described in the Clinical Quality Agreement.  GSK shall,  within the time defined in the Clinical Quality Agreement, perform (a) with respect to the  SpringWorks Compound, the acceptance (including testing) procedures allocated to it  under the Clinical Quality Agreement, and (b) with respect to the GSK BCMA Product,  the testing and release procedures allocated to it under the Clinical Quality Agreement.    12.12 Non-Conformance.    (a) In the event that either Party becomes aware that any Compounds may have a Non- Conformance, despite any testing and quality assurance activities (including any  activities conducted by the Parties under Section 12.11 (After Manufacturer’s  Release)), such Party shall immediately notify the other Party in accordance with  the procedures of the Clinical Quality Agreement.  The Parties shall investigate  any Non-Conformance in accordance with Section 12.14 (Investigations) and any  discrepancy between them shall be resolved in accordance with Section 12.13  (Resolution of Discrepancies).  (b) In the event any proposed or actual shipment of the SpringWorks Compound (or  portion thereof) is agreed to have a Non-Conformance at the time of Delivery to  GSK, then unless otherwise agreed to by the Parties, SpringWorks shall replace  such SpringWorks Compound as is found to have a Non-Conformance. Unless  otherwise agreed to by the Parties in writing, the sole and exclusive remedies of  GSK with respect to any SpringWorks Compound that is found to have a Non- Conformance at the time of Delivery shall be (i) replacement of such SpringWorks  Compound as set forth in this Section 12.12(b), and (ii) indemnification under  Article 22 (to the extent applicable) and (iii) termination of this Agreement  pursuant to Section 24.2 (to the extent applicable, but subject to the applicable cure  periods set forth therein), provided that, for clarity, GSK shall not be deemed to be  waiving any of its rights to recall Compounds in accordance with the Clinical  Quality Agreement.  In the event that SpringWorks Compound is lost or damaged  by GSK after Delivery, SpringWorks shall use Commercially Reasonable Efforts  to provide additional SpringWorks Compound to GSK; provided that GSK shall  





 






CONFIDENTIAL       Page 26   reimburse SpringWorks for the actual cost of such replaced SpringWorks  Compound without mark-up.  (c) GSK shall be responsible for, and SpringWorks shall have no obligations or  liability with respect to, any GSK BCMA Product that is found to have a Non- Conformance.    12.13 Resolution of Discrepancies.  If SpringWorks disagrees with any determination of Non- Conformance by GSK, such dispute shall be escalated to SpringWorks’ Head of CMC and  GSK’s Director of Quality External Supply, North America, or such other persons as they  may designate in writing.  If such quality representatives cannot reach a resolution to the  discrepancy, they shall escalate it to the head of quality of each Party for resolution.  If each  Party’s head of quality cannot reach a resolution, the dispute resolution procedure set out  at Article 30 shall apply.  12.14 Investigations.  The process for investigations of any Non-Conformance shall be handled  in accordance with the provisions set forth in the Clinical Quality Agreement.  12.15 Regulatory Responsibility.  The responsibilities of the Parties with respect to  communication and filings with Regulatory Authorities related to the Compounds supplied  hereunder in connection with the activities under the Development Plan will be as set forth  in this Agreement, the Pharmacovigilance Agreement and the Clinical Quality Agreement  entered into by the Parties or their Affiliates in connection herewith.  12.16 Records; Audit and Inspection Rights.  SpringWorks will keep complete and accurate  records pertaining to the Manufacture, use and disposition, as applicable, of the  SpringWorks Compounds under this Agreement.  Any records relating to the quality of the  SpringWorks Compounds shall be kept in accordance with the terms of the Clinical Quality  Agreement. Without limiting the rights of audit included within the Clinical Quality  Agreement, upon the reasonable request of GSK, SpringWorks will make such records  open to review by GSK for the purpose of conducting investigations for the determination  of SpringWorks Compound safety and/or efficacy and compliance with this Agreement  with respect to the SpringWorks Compound or as required by Applicable Laws; provided  that (to the extent permitted by Applicable Laws) GSK provides written notice setting out  the reason for the audit no less than [***] days in advance and any such review or audit is  performed during business hours on a Business Day in the country where the audit takes  place and with minimum disruption to the day-to-day activities of SpringWorks.    12.17 Quality Control.  SpringWorks shall implement and perform operating procedures and  controls for sampling, stability and other testing of the SpringWorks Compound, and for  validation, documentation and release of the SpringWorks Compound and such other  quality assurance and quality control procedures as are required by the Specifications,  cGMPs and the Clinical Quality Agreement.  12.18 Recalls.  Recalls of the Compounds shall be governed by the terms of the Clinical Quality  Agreement.  12.19 Either Party may suspend the supply of its Compound under this Agreement (in whole or  in part on a country-by-country basis) immediately in the event that any Regulatory  Authority takes any action, or raises any objection, that prevents such Party from supplying  its Compound for purposes of this Agreement, provided that such Party provides written  notice of such suspension at least [***] Business Days in advance to the other Party unless  





 






CONFIDENTIAL       Page 27   circumstances necessitate a shorter time period, and in any event not less than a reasonable  time in advance under the circumstances. To the extent reasonably practicable, the Parties  shall discuss such proposed suspension and any steps to mitigate the consequences of such  suspension.   13. FINANCIAL PROVISIONS  13.1 In partial consideration of the rights granted to GSK under this Agreement, pursuant to and  in accordance with the terms of a separate Stock Purchase Agreement entered into by  SpringWorks and an Affiliate of GSK concurrently herewith, an Affiliate of GSK will  purchase from SpringWorks shares of common stock of SpringWorks for an aggregate  purchase price of Seventy-Five Million Dollars ($75,000,000).  13.2 GSK shall make the non-refundable, non-creditable payments (“Milestone Payments”) to  SpringWorks set forth below in accordance with Section 13.4 solely upon the occurrence  of the corresponding milestone event set forth below (each, a “Milestone Event”):   Milestone Event $  1. [***] in [***] [***]  2. [***] in [***] [***]  3. [***] in [***] [***]  4. [***] in [***] [***]  5 [***] in [***] [***]  6 [***] in [***] [***]  7. [***] in [***] [***]   Total Milestones Up to  $550,000,000    13.3 Each Milestone Payment shall be payable one time only, regardless of how many times the  Milestone Event is achieved and regardless of how many Combination Regimens are  Developed hereunder.  13.4 GSK shall notify SpringWorks in writing promptly, but in no event later than [***]  Business Days after becoming aware of the occurrence of such Milestone Event. GSK shall  pay all such Milestone Payments due in U.S. dollars on or prior to the [***] day of the  calendar month immediately following the [***] day after GSK’s receipt of an invoice  from SpringWorks following the achievement of the Milestone Event.   13.5 To the extent an invoice is required to be submitted to GSK hereunder, such invoice shall  include the information set forth in Schedule 13.5.      13.6 SpringWorks will be responsible for all Taxes imposed on SpringWorks’ net income, or on  net income allocated to SpringWorks under Applicable Law. GSK will make all payments  to SpringWorks under this Agreement without deduction or withholding for Taxes except  to the extent that any such deduction or withholding is required by Applicable Law in effect  at the time of payment.    13.7 Any Tax required to be withheld on amounts payable under this Agreement will promptly  be paid by GSK on behalf of SpringWorks to the appropriate governmental authority, and  GSK will furnish SpringWorks with proof of payment of such Tax. Except as provided in  Section 13.10, any such Tax, to the extent withheld and paid to the appropriate  





 






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.   





 






CONFIDENTIAL       Page 29   13.13 Each Party shall cooperate in good faith if requested by the other Party to establish or  facilitate an optimal inter-Party financial operational structure (including, if necessary,  procedures and agreements among the various Affiliates of the Parties) which is consistent  with the economic result contemplated herein, consistent to the extent feasible with each  Party’s internal structures and procedures, and not adverse to the Parties financial,  economic, or tax positions.    13.14 GSK shall use commercially reasonable efforts to provide information in GSK’s or its  Affiliate’s possession, which is reasonably requested by SpringWorks in order to determine  or prove eligibility for the Foreign Derived Intangible Income deduction pursuant to  Section 250 of the Internal Revenue Code of 1986 or any future deduction or credit that is  substantially similar to such deduction or which provides for a similar information or proof  requirement.   13.15 VAT.    (a) It is understood and agreed between the Parties that any payments made and any  other consideration given under this Agreement are each exclusive of VAT, which  shall be added thereon as applicable and at the relevant rate.  Subject to Section  13.15(b) where VAT is properly charged by the supplying Party and added to a  payment made or other consideration provided (as applicable) under this  Agreement, the Party making the payment or providing the other consideration (as  applicable) will pay the amount of VAT properly chargeable only on receipt of a  valid tax invoice from the supplying Party issued in accordance with Applicable  Law of the country in which the VAT is chargeable.  Each Party agrees that it shall  provide to the other Party any information and copies of any documents within its  control to the extent reasonably requested by the other Party for the purposes of  (i) determining the amount of VAT chargeable on any supply made under this  Agreement, (ii) establishing the place of supply for VAT purposes, or  (iii) complying with its VAT reporting or accounting obligations.  (b) Where one Party or its Affiliate (the “First Party”) is treated as making supply of  goods or services in a particular jurisdiction (for VAT purposes) for non-cash  consideration, and the other Party or its Affiliate (the “Second Party”) is treated  as receiving such supply in the same jurisdiction, thus resulting in an amount of  VAT being properly chargeable on such supply, the Second Party shall only be  obliged to pay to the First Party the amount of VAT properly chargeable on such  supply (and no other amount).  The Second Party shall pay such VAT to the First  Party on receipt of a valid VAT invoice from the First Party (issued in accordance  with Applicable Law of the jurisdiction in which the VAT is properly chargeable).   The Parties agree to (i) use their reasonable endeavours to determine and agree the  value of the supply that has been made and, as a result, the corresponding amount  of VAT that is properly chargeable, and (ii) provide to each other any information  or copies of documents in their control as are reasonably necessary to evidence that  such supply will take, or has taken, place in the same jurisdiction (for VAT  purposes).  13.16 All payments under this Agreement shall be paid in U.S. dollars by wire transfer to an  account designated by the receiving Party (which account the receiving Party may update  from time to time in writing).   





 






CONFIDENTIAL       Page 30   14. CONFIDENTIALITY.  14.1 GSK and SpringWorks each agree to hold in confidence any Confidential Information of  the other Party, and neither Party shall use Confidential Information of the other Party  except to fulfil such Party’s obligations or to exercise its rights under this Agreement.  For  the avoidance of doubt, for the purposes of this Agreement, regardless of which Party  discloses such Confidential Information to the other (a) all GSK IPR, GSK Regulatory  Documentation and Study Regulatory Documentation shall be Confidential Information of  GSK, and SpringWorks shall be deemed the receiving Party; (b) all SpringWorks IPR and  SpringWorks Regulatory Documentation shall be Confidential Information of  SpringWorks, and GSK shall be deemed the receiving Party; and (c) Clinical Data  (including Licensed Clinical Data) shall be the Confidential Information of GSK and  SpringWorks shall be deemed the receiving Party.  Confidential Information shall not be  disclosed by the receiving Party except as permitted by the terms of this Agreement or if  required to be filed with or disclosed to a Regulatory Authority or included in a label or  package insert for the receiving Party’s Compound.  Notwithstanding the foregoing,  (i) Jointly Owned Study Inventions that constitute Confidential Information shall constitute  the Confidential Information of both Parties and (ii) Study Inventions that constitute  Confidential Information and that are solely owned by one Party shall constitute the  Confidential Information of that Party, and in each case of (i) and (ii), each Party shall have  the right to use and disclose such Confidential Information consistent with this Article 14  and Articles 17 and 18.   14.2 Neither Party shall, without the prior written permission of the other Party, nor shall permit  any of its employees, consultants, agents, permitted Sublicensees and (sub)contractors  (“Representatives”) to, disclose any Confidential Information of the other Party to any  Third Party except to the extent disclosure is (a) required by Applicable Law, to prosecute  or defend litigation or to comply with the rules or regulations of any securities exchange,  including with respect to a securities offering; (b) required in order to fulfil the receiving  Party’s obligations under this Agreement or exercise the receiving Party’s rights to use and  disclose such Confidential Information as expressly provided for in this Agreement and  solely on a need-to-know basis; (c) necessary for the conduct of the activities under the  Development Plan and solely on a need-to-know basis; (d) to any bona fide potential or  actual investor, stockholder, investment banker, lender, acquirer, merger partner or other  actual financial partner and their representatives and advisors (including attorneys and  accountants) on a need-to-know basis; or (e) necessary for filing or prosecuting Joint Patent  Applications and/or Joint Patents as permitted pursuant to Article 17; provided that, in the  event of (a) above, the disclosing Party shall provide reasonable advance notice to the other  Party before making such disclosure (to the extent permitted by Applicable Law) and will  endeavour in good faith to secure confidential treatment of such Confidential Information  and/or reasonably assist the Party that owns such Confidential Information in seeking a  protective order or other confidential treatment, and in the event of each of (b), (c) and (d)  above, any Representative or Third Party to whom such Confidential Information is  disclosed is bound by obligations of confidentiality and non-use at least as stringent as  those set forth in this Agreement and the receiving Party remains liable for the compliance  of such parties with such obligations.    14.3 Each receiving Party acknowledges that in connection with its and its Representatives’ or  any Third Party’s examination of the Confidential Information of the disclosing Party, the  receiving Party and its Representatives and relevant Third Parties may have access to  material, non-public information, and that the receiving Party is aware, and will advise its  Representatives and Third Parties who are informed as to the matters that are the subject  





 






CONFIDENTIAL       Page 31   of this Agreement, that securities laws may impose restrictions on the dissemination of  such information and trading in securities when in possession of such information.     14.4 Notwithstanding any other provision of this Agreement, a Party may, without the other  Party’s consent, disclose Confidential Information to Affiliates, permitted Sublicensees,  contractors, IRBs, CROs, academic institutions, consultants, agents, and employees and  contractors engaged by study sites and clinical trial investigators performing the activities  under the Development Plan, the data safety monitoring and advisory board relating to any  Clinical Study, and Regulatory Authorities or other health authorities, in each case solely  to the extent necessary for the performance of the activities under the Development Plan  and provided such persons (other than governmental entities) are bound by an obligation  of confidentiality and non-use at least as stringent as the obligations contained herein.  14.5 When transferring Confidential Information, all communications between GSK and  SpringWorks will use encryption methods agreed to by the Parties.  Upon discovering any  suspected or actual unauthorized disclosure, loss or theft of Confidential Information (a  “Data Security Breach”), SpringWorks will send an e-mail to [***] notifying GSK, and  upon discovering any suspected or actual Data Security Breach, GSK will send an e-mail  to [***], notifying SpringWorks.  The Parties shall work with each other in good faith to  identify a root cause and remediate the Data Security Breach.  14.6 Each Party shall: (a) use strong encryption controls to protect all Confidential Information  from unauthorized disclosure, access or alteration in transit into or out of such Party’s  control over third-party networks; (b) maintain control processes in line with industry best  practice to detect, prevent, and recover from malware, viruses and spyware, including  updating antivirus, anti-malware and anti-spyware software at regular intervals; and (c)  maintain access management policies, procedures, and technical controls in line with  industry best practice to ensure all access to the other Party’s Confidential Information in  its control is appropriately authorized.  15. DATA PROTECTION.  15.1 Disclosing Party Obligations.  To the extent a Party (the “Disclosing Party”) discloses,  transfers or otherwise makes available any Personal Data to the other Party (the “Receiving  Party”) in connection with this Agreement, the Disclosing Party:  (a) shall, notwithstanding any other provision of this Agreement: (i) ensure, to the  extent practicable, that the Personal Data cannot be used by the Receiving Party to  identify a Data Subject and (ii) not provide the Receiving Party with any additional  information (if any), including any key codes or any other mechanism or data, that  may enable the Receiving Party to attribute the Personal Data to any identifiable  Data Subjects;  (b) represents and warrants that it has, to the best of its knowledge, complied with all  applicable Data Protection Laws from time to time relating to the processing of the  Personal Data; and  (c) in the event that the Receiving Party receives a request from a Regulatory Authority  in relation to any Personal Data transferred to the Receiving Party by the Disclosing  Party, agrees to provide reasonable assistance to the Receiving Party to enable it to  respond to the Regulatory Authority’s request which may involve contacting any  clinical sites, investigators or other subcontractors of the Disclosing Party and  





 






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  





 






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  





 






CONFIDENTIAL       Page 34   Law with the purposes disclosed to the relevant Data Subjects from time to time or  as otherwise permitted by applicable Data Protection Law;  (b) implement appropriate technical and organizational measures to ensure a level of  security appropriate to the risk, including as set forth in Section 14.6, taking into  account the state of the art, the costs of implementation and the nature, scope,  context and purpose of processing and promptly notify the Disclosing Party if any  Personal Data is subject to any unauthorized or unlawful access, loss, destruction  or damage; and  (c) not further disclose the Personal Data to any Third Party (including, for clarity, any  subcontractors) in a manner incompatible with the fair processing notice provided  to the relevant Data Subjects (and to the extent such notice is made available to the  Receiving Party by the Disclosing Party).  15.13 Data Subject Requests.  In the event that either Party directly receives a request from a  Data Subject for the rectification or erasure of such Personal Data (or any other request  regarding Data Subjects exercising rights under any applicable European Data Protection  Law) (a “Data Subject Request”), the Party receiving the request shall where appropriate  pass on the details of the request to the other Party and each Party shall provide the other  any reasonable assistance as is required for the purposes of responding to the Data Subject  Request in accordance with any applicable European Data Protection Law, which may  involve contacting clinical sites, investigators or other subcontractors of the disclosing  Party and providing additional information.  15.14 CCPA. To the extent that the CCPA is applicable to either Party: (i) such Party agrees to  comply with all of its obligations under the CCPA; and (ii) in relation to any  communication of “personal information” (as defined by the CCPA) from one Party to the  other Party pursuant to this Agreement, the Parties agree that no monetary or other valuable  consideration is being provided for such personal information and therefore neither Party  is “selling” (as defined by the CCPA) personal information to the other Party.  16. CLINICAL DATA OWNERSHIP & USE.   16.1 All Clinical Data generated under this Agreement shall be owned by GSK.   16.2 Consistent with GSK’s ownership of all Clinical Data pursuant to Section 16.1, and without  limiting the generality of Article 2, GSK shall have the right to use and analyze the Clinical  Data for all purposes, including, to use and analyze the Clinical Data in connection with  the independent Development, Commercialization or other exploitation of the GSK BCMA  Products (individually or in combination with other drugs and/or other pharmaceutical  agents, except as set forth in Section 16.3), and/or for inclusion in the safety database for  the GSK BCMA Products and the Combination Regimens, which rights shall survive any  expiration or termination of this Agreement.  16.3 SpringWorks hereby assigns, and shall cause its Affiliates to so assign, to GSK, without  additional compensation, such right, title and interest in and to any Clinical Data as is  necessary to fully effect the ownership described in Section 16.1, and agrees to execute all  instruments as may be reasonably necessary to effect the same.  Subject to Article 14, each  Party shall have the right to use the Licensed Clinical Data, both within and outside the  scope of the activities conducted under the Development Plan, without accounting to or  any other obligation to the other Party; provided, however, that SpringWorks may not use  





 






CONFIDENTIAL       Page 35   the Licensed Clinical Data, directly or indirectly, (a) to research, Develop or  Commercialize  (i) a compound that has the same [***] (each such compound a “GSK- Related Compound”) or (ii) the SpringWorks Compound as part of any combination with  any Third Party compound that is a GSK-Related Compound, or (b) to Promote (including,  without limitation, by means of comparator) a BCMA-directed therapy or the SpringWorks  Compound as part of any combination with any BCMA-directed therapy (other than a GSK  BCMA Product), nor grant any Third Party the right to do the same in relation to (a) or (b).   Notwithstanding the foregoing, SpringWorks shall have the right to use or disclose the  Licensed Clinical Data (x) in performing its obligations and exercising its rights under this  Agreement, (y) as may be necessary to comply with Applicable Laws, including as required  to respond to regulatory queries, or with policies and procedures with respect to  pharmacovigilance and adverse event reporting; or (z) to share with Third Parties or  Affiliates safety data where, due to severity, frequency or lack of reversibility,  SpringWorks needs to use such safety data with respect to the SpringWorks Compound or  the Combination Regimen to ensure patient safety.  For clarity, nothing in this Section 16.3  shall restrict or prevent SpringWorks from directly or indirectly, researching, developing  or commercializing a GSK-Related Compound, without the use of the Licensed Clinical  Data, and the restrictions set forth in this Section 16.3 will not apply to any Licensed  Clinical Data that becomes public other than by a breach of Article 14. For clarity,  SpringWorks shall not be entitled to disclose the Licensed Clinical Data to any Third Party,  save as provided in Article 14 or this Section 16.3.    17. INTELLECTUAL PROPERTY.    17.1 Save as expressly stated otherwise in this Agreement, all inventions conceived under or in  connection with this Agreement shall be owned based on inventorship as determined  according to U.S. patent law.   17.2 Inventions Owned by GSK.  The Parties agree that all rights to (a) GSK Background  Intellectual Property and (b) Study Inventions solely relating to (i) the GSK BCMA  Products or (ii) any GSK-Related Compound, are in each case the exclusive property of or  shall be exclusively controlled by GSK (each such invention described in (b)(i) and (b)(ii)  a “GSK Invention”, and together with the GSK Background Intellectual Property, the  “GSK IPR”).  As between the Parties, GSK shall be entitled to file in its own name relevant  patent applications and to own resultant patent rights for all GSK IPR. For the avoidance  of doubt, and subject to Article 16, as between the Parties, any Intellectual Property Rights  subsisting in the Clinical Data shall be the exclusive property of or shall be exclusively  controlled by GSK.   17.3 Inventions Owned by SpringWorks.  The Parties agree that all rights to (a) SpringWorks  Background Intellectual Property and (b) Study Inventions solely relating to (i) the  SpringWorks Compound or (ii) any SpringWorks-Related Compound, are in each case the  exclusive property of SpringWorks (each such invention described in (i) and (ii) a  “SpringWorks Invention”, and together with the SpringWorks Background Intellectual  Property, the “SpringWorks IPR”).  As between the Parties, SpringWorks shall be entitled  to file in its own name relevant patent applications and to own resultant patent rights for all  SpringWorks IPR.    17.4 Joint Ownership and Prosecution.  (a) Subject to Sections 17.2 and 17.3, all rights to all Study Inventions relating to, or  covering (i.e., contains a claim which would be infringed by), [***] (a “Jointly  





 






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  





 






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 Hatch-Waxman 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 Hatch-Waxman 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  





 






CONFIDENTIAL       Page 38   be first applied to the out-of-pocket costs of each Party in connection with such  action; and then (ii) any remaining proceeds shall be shared by the Parties in  proportion based on their relative contributions to the total costs and expenses of  the litigation, including any costs and expenses of a Party to enforce any solely  owned patents. A settlement or consent judgment or other voluntary final  disposition of a suit under this Section 17.4(d) may not be entered into without the  consent of the Party not bringing the suit (such consent not to be unreasonably  withheld or delayed). Furthermore, the Party not bringing the suit shall not offer  the defendant in such suit any license under the Joint Patent(s) without the consent  of the Party bringing the suit.    17.5 Each Party hereby assigns, and shall cause its Affiliates to so assign, to the other Party,  without additional compensation, such right, title and interest in and to any Study  Inventions as is necessary to fully effect the ownership described in Sections 17.2, 17.3,  and 17.4, and agrees to execute all instruments as may be reasonably necessary to effect  the same.    18. PUBLICATIONS.  18.1 In relation to Clinical Studies conducted under the Development Plan, the Parties, acting  through the JDC, shall discuss and agree to a publication strategy that will (a) be consistent  with GSK internal policies regarding dissemination of data by GSK as study sponsor, and  (b) will include the requirements for publication set forth in Section 18.2. The Parties will  comply with the agreed-upon publication strategy with respect to any publications of results  of Clinical Studies performed hereunder.  18.2 Subject to Section 18.1, GSK shall have the right at any time during and after the Term to  (a) publish the results or summaries of results of all Clinical Studies conducted with respect  to any and all Combination Regimens in the Field in any clinical trial register maintained  by GSK or its Affiliates and the protocols of such clinical studies on www.clinicaltrials.gov  or in each case publish the results, summaries or protocols of such Clinical Studies on such  other websites or repositories or at scientific congresses and in peer-reviewed journals  within such timescales as required by Applicable Law or GSK’s or its Affiliate’s internal  policies, irrespective of the outcome of such clinical studies; (b) make information from  Clinical Studies conducted by or on behalf of GSK with respect to a Combination Regimen  in the Field available under its Data Sharing Initiative; and (c) make any other public  disclosures of Clinical Data that become required of GSK due to its internal policies and  procedures or Applicable Laws.  18.3 Prior to submission by GSK of the results of a Clinical Study for publication or presentation  or any other dissemination (each, a “Publication”) of Clinical Study results including oral  dissemination, whether or not in accordance with the agreed publication strategy, GSK  shall invite SpringWorks to comment on the content of the material to be published or  presented according to the following procedure:   (a) At least [***] days prior to submission for publication of any paper, letter or any  other publication, or [***] days prior to submission for presentation of any abstract,  poster, talk or any other presentation, GSK shall provide to SpringWorks the full  details of the proposed Publication in electronic version.  Upon written request  from SpringWorks, GSK agrees not to submit data for publication or presentation  for an additional [***] days in order to allow for actions to be taken to preserve  rights for patent protection.  





 






CONFIDENTIAL       Page 39   (b) GSK shall give reasonable consideration to any request by SpringWorks made  within the periods mentioned in clause (a) above to modify the Publication.  (c) GSK shall remove all Confidential Information of SpringWorks if requested by  SpringWorks before finalizing the Publication.    (d) In the event of a disagreement as to content, timing and/or venue or forum for any  Publication, such dispute shall be referred to the medicine development leader from  each Party (or their respective designees) to be resolved by way of good faith  discussions for a period of [***] days following such referral; provided that, GSK  may proceed with the Publication provided that such Publication is consistent with  the agreed publication strategy, its internal publication guidelines and customary  industry practices for the publication of similar data and does not disclose the  Confidential Information of SpringWorks. Authorship of any Publication shall be  determined based on the accepted standards used in peer-reviewed academic  journals at the time of the proposed Publication.   18.4 SpringWorks shall not publish the results of any Clinical Study conducted under the  Development Plan prior to the publication of such Clinical Study results by GSK as set  forth above.  Thereafter, SpringWorks shall not publish, for any purpose, the results of the  Clinical Studies except in accordance with the agreed publication strategy.  The rights of  SpringWorks set forth in Sections 18.3(a) through 18.3(d) shall apply mutatis mutandis to  GSK when SpringWorks is the publishing Party in accordance with this Section 18.4.    18.5 The Parties have agreed on the language of SpringWorks’ press release regarding the  subject matter of this Agreement, which is attached hereto as Appendix B. Except for the  foregoing initial press release, if either Party wishes or is required to make any public  disclosure regarding the subject matter of this Agreement, it shall first notify the other Party  of such planned press release or public announcement and provide a draft for review and  comment at least [***] Business Days in advance of issuing such press release or making  such public announcement (or, with respect to press releases and public announcements  that are required by Applicable Law, or by regulation or rule of any public stock exchange,  including with respect to a securities offering, with as much advance notice as possible  under the circumstances if it is not possible to provide notice at least [***] Business Days  in advance), except for any such disclosure that repeats any information regarding this  Agreement, its subject matter or any amendment hereto that has already been publicly  disclosed by either Party in accordance with this Section 18.5, provided that such  information remains accurate as of such time and provided the frequency and form of such  disclosure are reasonable. A Party may notify the disclosing Party of any reasonable  objections or suggestions that the non-disclosing Party may have regarding the proposed  press release or public announcement, and the disclosing Party shall reasonably consider  any such objections or suggestions that are provided in a timely manner.   19. USE OF NAME.  19.1 Except as otherwise provided herein, neither Party shall have any right, express or implied,  to use in any manner the name or other designation of the other Party or any other trade  name, trademark or logo of the other Party for any purpose in connection with the  performance of this Agreement.  





 






CONFIDENTIAL       Page 40   20. REPRESENTATIONS AND WARRANTIES; DISCLAIMERS.  20.1 Each of GSK and SpringWorks represents and warrants to the other that it has the power  and authority and the legal right to enter into this Agreement and perform its obligations  hereunder.  20.2 SpringWorks hereby represents and warrants to GSK that, at the time of Delivery of the  SpringWorks Compound for the conduct of activities under the Development Plan, such  SpringWorks Compound shall have been Manufactured in compliance with: (a) the  Specifications for the SpringWorks Compound; (b) the Clinical Quality Agreement; and  (c) all Applicable Law, including cGMP and health, safety and environmental protections.    20.3 Each of GSK and SpringWorks represents and warrants to the other that, to its knowledge  as of the Effective Date, the Development of the Combination Regimens in the Field as  contemplated hereunder does not and will not infringe upon or misappropriate any  Intellectual Property Rights or other rights of any Third Parties.  20.4 Each of GSK and SpringWorks represents and warrants to the other that, to its knowledge  as of the Effective Date, the Commercialization of its Compound either alone or as part of  the Combination Regimens in the Field does not and will not infringe any issued patent or  misappropriate any other Intellectual Property Rights of any Third Parties.  20.5 Each of GSK and SpringWorks represents and warrants to the other as of the Effective Date  that, (i) no written claim of infringement of the Intellectual Property Rights of any Third  Party has been made or threatened in writing, against such Party or any of its Affiliates  with respect to the Development, Manufacture or Commercialization of such Party’s  Compound, and (ii) there are no other judgments or settlements against or owed by such  Party or to which such Party is a party or, to such Party’s knowledge, pending litigation or  litigation threatened in writing, in each case in relation to such Party’s Compound.  20.6 Each Party represents and warrants to the other Party that, to its knowledge, all necessary  consents, approvals and authorizations of all Regulatory Authorities and other  governmental organizations or other persons required to be obtained by such Party in  connection with the performance of its obligations under this Agreement have been  obtained or will be obtained prior to such performance.  20.7 Each Party represents and warrants to the other Party that it shall comply with all  Applicable Law of the country or other jurisdiction, or any court or agency thereof,  applicable to the performance of its activities hereunder (including any activities performed  by either Party pursuant to Section 8.2) or any obligation hereunder, including those  pertaining to the production and handling of therapeutic drug products, such as those set  forth by Regulatory Authorities, as applicable, and the applicable terms of this Agreement  in the performance of its obligations hereunder.   20.8 Each Party shall comply with its respective obligations under any agreements entered into  by it with a Third Party under which it is licensed any Intellectual Property Rights or  Confidential Information relating to a Compound (and not to voluntarily terminate same)  to the extent necessary for the other Party to receive the rights and benefits provided to it  under this Agreement.  20.9 SpringWorks represents and warrants that, prior to the Effective Date, SpringWorks has  provided GSK with an opportunity to review complete and correct copies of the Amended  and Restated License Agreement by and among SpringWorks Subsidiary 2, Inc., Pfizer  





 






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.  





 






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  





 






CONFIDENTIAL       Page 43   agencies, and to whomsoever such Party determines in good faith has a legitimate need to  know.  21.8 Each Party shall provide anti-bribery and anti-corruption training to all personnel,  including any relevant subcontractors, of such Party who act on behalf of the other Party  or interact with Government Officials during the course of any services provided to the  other Party in connection with this Agreement. Each Party shall provide the other Party the  opportunity to evaluate the training to determine whether it abides by the evaluating Party’s  standards and shall conduct additional training, as requested by the evaluating Party. Each  Party, upon request by the other Party, shall certify in writing that the anti-bribery and anti- corruption training has taken place.  21.9 Each Party shall be entitled to terminate this Agreement immediately on written notice to  the other Party if such other Party is in breach of this Article 21.  The breaching Party shall  have no claim against the non-breaching Party for compensation for any loss of whatever  nature by virtue of the termination of this Agreement in accordance with this Section 21.9.  22. INDEMNIFICATION.    22.1 Indemnification by GSK.  GSK agrees to defend, indemnify and hold harmless  SpringWorks, its Affiliates, and its and their employees, directors, subcontractors and  agents from and against any loss, damage, reasonable costs and expense (including  reasonable legal expenses, including attorneys’ fees and expenses) incurred in connection  with any claim, proceeding, or action by a Third Party (a “Liability”) arising out of this  Agreement to the extent such Liability (a) is directly caused by (i) the negligence or wilful  misconduct on the part of GSK (or any of its Affiliates, or its and their employees, directors,  subcontractors or agents); or (ii) a breach on the part of GSK of any of its representations  and warranties or any other covenants or obligations of GSK under this Agreement; or (b)  is determined to be solely attributable to the GSK BCMA Product.    22.2 Indemnification by SpringWorks.  SpringWorks agrees to defend, indemnify and hold  harmless GSK, its Affiliates, and its and their employees, directors, subcontractors and  agents from and against any Liability arising out of this Agreement to the extent such  Liability (a) is directly caused by (i) the negligence or wilful misconduct on the part of  SpringWorks (or any of its Affiliates, or its and their employees, directors, subcontractors  or agents); or (ii) a breach on the part of SpringWorks of any of its representations and  warranties or any other covenants or obligations of SpringWorks under this Agreement; or  (b) is determined to be solely attributable to the SpringWorks Compound.   22.3 Procedure.  The obligations of GSK and SpringWorks under this Article 22 are  conditioned upon the delivery of written notice to the relevant indemnifying Party of any  potential Liability within a reasonable time after the indemnified Party becomes aware of  such potential Liability.  The indemnifying Party will have the right to assume the defense  of any suit or claim related to the Liability if it has assumed responsibility for the suit or  claim in writing and the indemnified Party shall provide reasonable assistance to the  indemnifying Party, at the indemnifying Party’s expense, in the investigation of,  preparation for and defense of any such suit or claim.  The indemnified Party may  participate in (but not control) the defense thereof at its sole cost and expense.  The Party  controlling such defense shall keep the other Party advised of the status of such action, suit,  proceeding or claim and the defense thereof.  The Party controlling the defense shall not  agree to any settlement of such action, suit, proceeding or claim without the prior written  consent of the other Party, which shall not be unreasonably withheld.  The controlling  





 






CONFIDENTIAL       Page 44   Party, but solely to the extent it is also the indemnifying Party, shall not agree to any  settlement of such action, suit, proceeding or claim or consent to any judgment in respect  thereof that does not include a complete and unconditional release of the non-controlling  Party from all liability with respect thereto or that imposes any liability or obligation on the  non-controlling Party without the prior written consent of the non-controlling Party.  22.4 Notwithstanding the provisions of Section 22.3, in the event that the Parties cannot agree  as to the application of Sections 22.1 or 22.2 regarding any particular Liability, the Parties  may conduct separate defenses of any suit or claim related to such Liability.  Each Party  further reserves the right to claim indemnity from the other in accordance with Sections  22.1 or 22.2, as applicable, upon resolution of the underlying claim.  23. LIMITATION OF LIABILITY  23.1 OTHER THAN WITH RESPECT TO THE OBLIGATIONS OF EITHER PARTY  UNDER ARTICLES 14 (CONFIDENTIALITY) AND 15 (DATA PROTECTION)  AND/OR A PARTY’S INDEMNIFICATION OBLIGATIONS HEREUNDER: IN NO  EVENT SHALL EITHER PARTY (OR ANY OF ITS AFFILIATES, SUBLICENSEES  OR SUBCONTRACTORS) BE LIABLE TO THE OTHER PARTY FOR ANY  INDIRECT, PUNITIVE OR CONSEQUENTIAL OR SPECIAL DAMAGES  (INCLUDING LOST PROFITS OR DAMAGES FOR LOST OPPORTUNITIES),  WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT  LIABILITY OR OTHERWISE, ARISING OUT OF OR RELATING TO (x) THE  MANUFACTURE, USE OR SALE OF ANY COMPOUND SUPPLIED HEREUNDER  OR (y) ANY BREACH OF OR FAILURE TO PERFORM ANY OF THE PROVISIONS  OF THIS AGREEMENT OR ANY REPRESENTATION OR WARRANTY  CONTAINED IN OR MADE PURSUANT TO THIS AGREEMENT;.  NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS AGREEMENT,  NEITHER PARTY EXCLUDES OR LIMITS ITS LIABILITY FOR FRAUD, DEATH  OR PERSONAL INJURY CAUSED BY ITS NEGLIGENCE OR THAT OF ITS  AFFILIATES, AND ITS AND THEIR EMPLOYEES, DIRECTORS,  SUBCONTRACTORS AND AGENTS, WILFUL MISCONDUCT, GROSS  NEGLIGENCE, INTENTIONAL DEFAULT OR ANY LOSSES TO THE EXTENT NOT  CAPABLE OF BEING EXCLUDED OR LIMITED BY LAW.  24. TERM AND TERMINATION.    24.1 The term of this Agreement shall commence on the Effective Date and shall continue in  full force and effect, unless earlier terminated by either Party pursuant to this Article 24  (the “Term”).    24.2 Either Party may, subject to the provisions of this Section 24.2, immediately terminate this  Agreement if there is an uncured material breach of this Agreement by the other Party. To  exercise its termination rights under this Section 24.2, the non-breaching Party shall  provide the breaching Party with written notice, which notice will, in each case (i) expressly  reference this Section 24.2, (ii) reasonably describe the alleged breach which is the basis  of such termination, and (iii) clearly state the non-breaching Party’s intent to terminate this  Agreement if the alleged breach is not cured within the applicable cure period.  If such  breaching Party, upon receiving such written notice identifying such material breach in  reasonable detail, fails to cure such material breach within (a) [***] days after receipt of  written notice thereof from the non-breaching Party with respect to any breach of any  payment obligation under this Agreement and (b) [***] days’ after receipt of written notice  





 






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  





 






CONFIDENTIAL       Page 46   concludes that the issue adversely impacts the activities under the Development Plan and  is not solvable or that unacceptable and material additional costs/delays have been and/or  will continue to be incurred in the conduct of the activities under the Development Plan,  then such Party may immediately terminate this Agreement.   25. EFFECT OF TERMINATION.    25.1 Termination or expiration of this Agreement shall be without prejudice to any claim or right  of action of either Party against the other Party for any prior breach of this Agreement.  25.2 Upon termination of this Agreement for any reason:   (a) Except as otherwise set forth in this Article 25, as of the effective date of such  termination, all rights and obligations of the Parties under this Agreement will  terminate.  (b) Each receiving Party shall, upon request by the disclosing Party, immediately  destroy or return all of the other Party’s Confidential Information in its possession  (except to the extent such information is the Confidential Information of both  Parties or to the extent that it is necessary for the receiving Party to have a  continuing right to use the Confidential Information in accordance with the  exercise of its rights or performance of its obligations under this Agreement post  such termination). Each Party shall be entitled to retain one (1) copy of the other  Party’s Confidential Information solely for record-keeping purposes; provided that  a Party shall not be required to destroy electronic files containing Confidential  Information that are made in the ordinary course of its business information back- up procedures pursuant to its electronic record retention and destruction practices  that apply to its own general electronic files and information.  (c) In the event the effective date of termination is prior to [***]:  (i) where GSK terminates under Sections 24.2 or Section 24.3:   (A) 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  (B) SpringWorks shall continue to supply, or cause to be supplied, at  its sole cost and expense, cGMP-grade quantities of SpringWorks  Compound in such quantities, formulations and dosages  reasonably requested by GSK in order to complete any Clinical  Study under the Development Plan that is ongoing at the effective  date of such termination.   (ii) where the Agreement is terminated for any reason other than by GSK under  Sections 24.2 or Section 24.3:  (A) GSK shall, at SpringWorks’ sole discretion, promptly either return  or destroy all unused SpringWorks Compound in GSK’s  





 






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),  





 






CONFIDENTIAL       Page 48   31 (Notices), 32 (No Waiver), 33 (Further Assurance), 34 (No Benefit to Third Parties),  35 (Relationship of the Parties) and 37 (Construction) shall survive the termination of this  Agreement. Sections 2 (License Grants), 7.5 (Right of Reference) and 13 (Financial  Provisions) shall survive the termination of this Agreement to the extent specified in  Section 25.2(c), 25.2(d) and/or 25.2(e).   26. FORCE MAJEURE.    If in the performance of this Agreement, one of the Parties is prevented, hindered or delayed  by reason of any cause beyond such Party’s reasonable control (e.g., war, riots, fire, strike,  governmental laws), such Party shall be excused from such performance to the extent that  it is necessarily prevented, hindered or delayed (“Force Majeure”). The non-performing  Party will use reasonable efforts to notify the other Party of such Force Majeure within  [***] days after such occurrence by giving written notice to the other Party stating the  nature of the event, its anticipated duration, and any action being taken to avoid or minimize  its effect. The suspension of performance will be of no greater scope and no longer duration  than is necessary and the non-performing Party will use Commercially Reasonable Efforts  to remedy its inability to perform. If the period of any resulting delay or hindrance to such  Party’s performance of its obligations, or non-performance thereof, continues for [***]  days, the other Party may terminate this Agreement immediately upon written notice to the  non-performing Party.  27. ENTIRE AGREEMENT; MODIFICATION.  With effect from the Effective Date, this Agreement amends, restates and supersedes in its  entirety the Original Agreement, provided, however that the foregoing shall in no event  limit the applicable Parties’ rights and obligations that have accrued under the Original  Agreement prior to the Effective Date. The Parties agree that, from the Effective Date, the  Sub-Study shall be governed by this Agreement and the Original Agreement shall be of no  further legal force or effect, save as amended and restated in this Agreement. This  Agreement, together with the Stock Purchase Agreement, Clinical Quality Agreement and  the Pharmacovigilance Agreement, constitutes the sole, full, final, complete and exclusive  agreement by and between the Parties with respect to the subject matter of this Agreement,  and all prior agreements, understandings, promises and representations, whether written or  oral, with respect thereto are superseded by this Agreement.  No amendments, changes,  additions, deletions or modifications to or of this Agreement shall be valid unless reduced  to writing and duly executed by authorized representatives of the Parties hereto.      28. ASSIGNMENT.  Neither Party shall assign or transfer its rights or obligations under this Agreement in part  or in whole without the prior written consent of the other Party; provided, however, that  (a) either Party may assign this Agreement, without the other Party’s consent, to (i) one or  more of its Affiliates, (ii) a Third Party in a connection with a Change of Control of the  assigning Party or (iii) to a Third Party that acquires all the rights of the assigning Party to  the GSK BCMA Product, in the case of GSK, or the SpringWorks Compound, in the case  of SpringWorks; and (b) any and all rights and obligations of either Party may be exercised  or performed by its Affiliates, provided that such Affiliates agree to be bound by this  Agreement.  If this Agreement is assigned or transferred to an Affiliate, the  assigning/transferring Party shall remain jointly and severally liable with the  assignee/transferee Affiliate for the assigned rights and obligations.  Any assignment or  





 






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  





 






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).  





 






CONFIDENTIAL       Page 51   31. NOTICES.  All notices or other communications that are required or permitted hereunder shall be in  writing and delivered by internationally-recognized overnight courier addressed as follows:  If to GSK, to:  [***]  With a copy to  [***]  If to SpringWorks, to:  [***]    With copies to:    [***]    Any such communication shall be deemed to have been received when delivered to the recipient,  if sent before [***] on a Business Day in the recipient’s jurisdiction, or at [***] on the next Business  Day in the recipient’s jurisdiction, if sent after [***] or not on a Business Day.  It is understood and  agreed that this Article 31 is not intended to govern the day-to-day business communications  necessary between the Parties in performing their duties, in due course, under the terms of this  Agreement.  32. NO WAIVER.  It is agreed that no waiver by a Party of any breach or default of any of the covenants or  agreements set forth herein shall be deemed a waiver as to any subsequent and/or similar  breach or default.  33. FURTHER ASSURANCE.  Each Party shall duly execute and deliver, or cause to be duly executed and delivered, such  further instruments and do and cause to be done such further acts and things, including the  filing of such assignments, agreements, documents and instruments, as may be necessary  or as the other Party may reasonably request in order to perfect any license, assignment or  other transfer or any properties or rights under, or pursuant, to this Agreement.  34. NO BENEFIT TO THIRD PARTIES.  The representations, warranties and agreements set forth in this Agreement for the sole  benefit of the Parties and their successors and permitted assigns, and they shall not be  construed as conferring any rights on any other Parties.  35. RELATIONSHIP OF THE PARTIES.  The relationship between the Parties is and shall be that of independent contractors, and  does not and shall not constitute a partnership, joint venture, agency or fiduciary  relationship.  Neither Party shall have the authority to make any statements, representations  





 






CONFIDENTIAL       Page 52   or commitments of any kind, or take any actions, for or on behalf of the other Party, except  with the prior written consent of the other Party to do so.  All persons employed by a Party  will be the employees of such Party and not of the other Party and all costs and obligations  incurred by reason of any such employment shall be for the account and expense of such  Party.  36. COUNTERPARTS AND DUE EXECUTION.  This Agreement and any amendment may be executed in two (2) or more counterparts  (including by way of electronic transmission (e.g. PDF)), each of which shall be deemed  an original, but all of which together shall constitute one and the same instrument,  notwithstanding any electronic transmission, storage and printing of copies of this  Agreement from computers or printers and such signatures shall be deemed to bind each  Party hereto as if they were original signatures.  When executed by the Parties, this  Agreement shall constitute an original instrument, notwithstanding any electronic  transmission, storage and printing of copies of this Agreement from computers or printers.   For clarity, signatures transmitted via PDF shall be treated as original signatures.  37. CONSTRUCTION.  Except where the context otherwise requires, wherever used, the singular will include the  plural, the plural the singular, the use of any gender will be applicable to all genders, the  word “or” is used in the inclusive sense (and/or), and the words “will” and “shall” are  synonymous to indicate an obligation.  Whenever this Agreement refers to a particular  statute or regulation, such reference shall include all rules and regulations promulgated  thereunder and any successor statute, rules or regulations then in effect, in each case  including the then-current amendments thereto.  Whenever this Agreement refers to a  number of days, unless otherwise specified, such number refers to calendar days.  The  captions of this Agreement are for convenience of reference only and in no way, define,  describe, extend or limit the scope or intent of this Agreement or the intent of any provision  contained in this Agreement.  The term “including” as used herein shall be deemed to be  followed by the phrase “without limitation” or like expression.  The term “will” as used  herein means shall.  References to “Article,” “Section” or “Appendix” are references to the  numbered sections of this Agreement and the appendices attached to this Agreement, unless  expressly stated otherwise.  Except where the context otherwise requires, references to this  “Agreement” shall include the appendices attached to this Agreement.  The language of  this Agreement shall be deemed to be the language mutually chosen by the Parties and no  rule of strict construction will be applied against either Party hereto.  [Signature page follows.]  





 






CONFIDENTIAL    [SIGNATURE PAGE]    IN WITNESS WHEREOF, the respective representatives of the Parties have executed  this Agreement as of the Effective Date.    GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LIMITED  By: /s/ Paul Money___________________   Name: Paul Money   Title:  Authorised Signatory, representing   Glaxo Group Limited, Corporate Director    





 






CONFIDENTIAL    [SIGNATURE PAGE]  SPRINGWORKS THERAPEUTICS, INC.  By: /s/ Saqib Islam______________________  Name:  Saqib Islam   Title:    Chief Executive Officer     





 






CONFIDENTIAL        Schedule 3.1  INITIAL DEVELOPMENT PLAN    [***]  





 






CONFIDENTIAL      Schedule 12.2    SpringWorks Back-Up Supplier    [***]   





 






CONFIDENTIAL          Schedule 13.5    Invoicing and Bank Details Instructions    [***]      





 






CONFIDENTIAL             Appendix A  SUPPLY OF COMPOUND  [***]  





 






        Appendix B  PRESS RELEASE  [See Attached]      





 






          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 Saqib Islam, 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 Hesham A. Abdullah, M.D., M.Sc., 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  





 






        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 www.springworkstx.com 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,  





 






        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:  Kim Diamond  Vice President, Communications and Investor Relations  Phone: 203-561-1646   Email: kdiamond@springworkstx.com     Samantha Hilson Sandler  Director, Investor Relations  Phone: 203-461-5501  Email: samantha.sandler@springworkstx.com