Article 1 Definitions

1

Article 2 Effectiveness

29

Article 3 DEVELOPMENT Program

29

Article 4 Regulatory matters

44

Article 5 Manufacturing and supply

47

Article 6 COMMERCIALIZATION; MEDICAL AFFAIRS

49

Article 7 Management of the Collaboration

63

Article 8 Financial Provisions

73

Article 9 Licenses; EXCLUSIVITY

87

Article 10 CONFIDENTIALITY; Publications and Presentations

93

Article 11 INTELLECTUAL PROPERTY

98

Article 12 Term and Termination

104

Article 13 Effects of Expiration or Termination

106

Article 14 Representations and Warranties AND Covenants

112

Article 15 Indemnification

115

Article 16 DISPUTE RESOLUTION

118

Article 17 MISCELLANEOUS

120

1.1

“AAA Rules” has the meaning set forth in Section 16.2 (Arbitration).

1.2

“ACCME Standards” has the meaning set forth in Section 6.9.3 (Applicable Laws and Guidelines).

1.3

“Accounting Standards” means, with respect to GSK, IFRS, and with respect to ITEOS, GAAP, in each case, as consistently applied by the applicable Party and its Affiliates, as the same may be changed from time to time by the Parties.

1.4

“Acquiree” has the meaning set forth in Section 9.12.3(b) (New Affiliate Exception).

1.5

“Acquiror” has the meaning set forth in Section 9.12.3(a) (New Affiliate Exception).

1.6

“Additional Development Activities” has the meaning set forth in Section 3.4.1 (Additional Development Proposals).

1.7

“Additional Development Proposal” has the meaning set forth in Section 3.4.1 (Additional Development Proposals).

1.8

“Affiliate” means, with respect to a given Party, any corporation, firm, limited liability company, partnership or other entity that directly or indirectly controls, or is controlled by, or is under common control with such Party.  For the purposes of this Section 1.8 (Affiliate), “control” means ownership, directly or indirectly through one or more Affiliates, of more than fifty percent (50%) of the shares of stock entitled to vote for the election of directors, in the case of a corporation, or more than fifty percent (50%) of the equity interests in the case of any other type of legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a corporation or other entity controls or has the right to control the board of directors or equivalent governing body or management of another corporation or other entity.

1.9

“Agreement” has the meaning set forth in the preamble.

1.10

“Alliance Manager” has the meaning set forth in Section 7.8 (Alliance Managers).

1.11

“Allowable Expenses” has the meaning set forth in the Pre-Tax Profit or Loss Schedule.

1.12

“AMA” has the meaning set forth in Section 6.9.3 (Applicable Laws and Guidelines).

1.13

“Applicable Law” means, individually and collectively, any and all laws, statutes, ordinances, rules, directives and regulations of any governmental or regulatory authority within the applicable jurisdiction that may be in effect from time to time that apply to a Party’s activities or obligations under or in connection with this Agreement, including, if applicable, GMP, GLP, GCP, the FD&C Act, the Prescription Drug Marketing Act of 1987, the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a et seq.), the Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.), the False Claims Act (31 U.S.C. § 3729 et seq.), Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Patient Protection and Affordable Care Act (42 U.S.C. § 18001 et seq.), the Social Security Act (42 U.S.C. Chapter 7), the Antifraud and Abuse Amendment to the Social Security Act, Federal Program Fraud Civil Remedies Act (31 U.S.C. § 3801 et seq.), FCPA, Data Protection Laws, and all applicable implementing regulations for the foregoing, and all applicable state laws and the laws of the District of Columbia corresponding to any of the foregoing, all as amended from time to time.

1.14

“Approved Labeling” means, with respect to a Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.

1.15

“Arising Technology” means all Patents and Know-How invented, discovered, created or developed by or on behalf of a Party solely or the Parties jointly in connection with the exercise of its or their rights or performance of its or their obligations under this Agreement.

1.16

“Background Technology” of a Party means, in the case of GSK, the GSK Background Technology, and in the case of ITEOS, the ITEOS Background Technology.

1.17

“Balancing Payment” has the meaning set forth in Section 8.3.5(b) (Quarterly Reconciliation Payment).

1.18

“Bankruptcy Code” means Title 11 of the United States Code.

1.19

“Benchmark Countries” has the meaning set forth in Section 1.181 (Net Sales).

1.20

“Biosimilar Product” means with respect to a given Licensed Product in a particular country in the Territory, any product sold by a Third Party not authorized by GSK or its Affiliates or its or their Sublicensees that is approved by the applicable Regulatory Authority for such country through any application or submission filed with a Regulatory Authority for Regulatory Approval of a biological product determined to be biosimilar or interchangeable to such Licensed Product, including an application filed under 42 U.S.C. § 262(k) or any similar provisions in a country outside the United States, based in reliance, at least in part, on data generated for a Regulatory Approval of such Licensed Product.

1.21

“BLA” means a Biologics License Application (as more fully defined in 21 C.F.R. 601.2 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA.

1.22

“BPCIA” has the meaning set forth in Section 11.3.1 (Notification of Infringement).

1.23

“Breaching Party” has the meaning set forth in Section 12.3.1 (Termination for Material Breach).

1.24

“Business Day” means a day that is not (a) a Saturday, Sunday or a day on which banking institutions in New York, New York or London, United Kingdom are required by Applicable Law to remain closed, or (b) the nine (9) consecutive calendar days beginning on December 24 through and including January 1 of each Calendar Year to the extent those days are not included in (a) in this Section 1.24.

1.25

“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

1.26

“Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

1.27

“CDA” means that certain Mutual Confidential Disclosure Agreement between GlaxoSmithKline LLC and iTeos Belgium SA [***].

1.28

“Cessation” has the meaning set forth in Section 12.5 (Termination for Cessation of Development or Commercialization).

1.29

“Change of Control” means, with respect to a Party, an event or transaction or series of events or transactions by which: (a) any Third Party (or group of Third Parties acting in

concert) becomes the beneficial owner, directly or indirectly, of more than fifty percent (50%) of the outstanding securities of such Party or the total voting power of such securities normally entitled to vote in elections of directors; (b) (i) such Party reorganizes, consolidates or comes under common control with, or merges into another entity, or (ii) any entity reorganizes, consolidates or comes under common control with, or merges into, such Party, in either event of the foregoing ((i) or (ii)) where more than fifty percent (50%) of the total voting power of the securities outstanding of the surviving entity normally entitled to vote in elections of directors is not held by the parties holding at least fifty percent (50%) of the outstanding shares of such Party immediately preceding such consolidation or merger; or (c) such Party conveys, transfers or leases to a Third Party all or substantially all of its assets or business relating to this Agreement.

1.30

“Clinical Manufacturing” or “Clinical Manufacture” means Manufacture of a Licensed Product (including the cost of Manufacturing Licensed Antibody contained in Licensed Product) or acquisition of such Licensed Antibody and Licensed Product from a CMO, in each case, for use in Clinical Trials.

1.31

“Clinical Manufacture Costs” means Manufacturing Costs of the Manufacture of a given Licensed Product (including the cost of Manufacturing Licensed Antibody contained in Licensed Product) or other compound, antibody, or product Controlled by GSK, in each case, for clinical use of such Licensed Product or other compound, antibody, or product Controlled by GSK, as applicable, anywhere in the Territory.

1.32

“Clinical Trial” means any study in humans to obtain information regarding a pharmaceutical product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging, or efficacy of such product, including a Registration Study.

1.33

“CMC Development” means the following Development activities: test method development and stability testing, process development, control strategy and process validation, process scale-up, formulation development, delivery system development, quality assurance and quality control development, and other related activities, in each case, pertaining to Development of a process to Manufacture Licensed Antibody and Licensed Products.

1.34

“CMOs” has the meaning set forth in Section 1.167.2 (Manufacturing Cost).

1.35

“CMS” has the meaning set forth in Section 6.9.5 (Reporting).

1.36

“Co-Administration Studies” means clinical studies for co-administration (not co-formulation) of pharmaceutical products (that are not Licensed Products) together with the EOS-448 Sole Active Product.

1.37

“Co-Administration Therapy” means the use or method of using the EOS-448 Sole Active Product and at least one other pharmaceutical product together in either concomitant or sequential administration.  For the avoidance of doubt, a Co-Administration Therapy (a) will not be considered a Co-Formulated Product hereunder and (b) will not be considered

a Combination Product hereunder unless such Co-Administration Therapy is sold and invoiced under a single invoiced price.

1.38

“Co-Chair” has the meaning set forth in Section 7.6.1 (Membership).

1.39

“Co-Formulated Product” has the meaning set forth in Section 1.181 (Net Sales).

1.40

“Collaboration In-License” has the meaning set forth in Section 9.11.3 (New Collaboration In-Licenses).

1.41

“Combination Product” means a Licensed Product that includes a Licensed Antibody in combination with one or more pharmaceutically active ingredients that is not any other Licensed Antibody (the “Other Component(s)”), whether in a single formulation finished form, co-packaged, or as separate products otherwise sold and invoiced under a single invoiced price.

1.42

“Commercial Manufacturing” or “Commercial Manufacture” means Manufacture of a Licensed Product (including the cost of Manufacturing Licensed Antibody contained in Licensed Product) or acquisition of such Licensed Antibody and Licensed Product from a CMO, in each case, for Commercialization of such Licensed Product in the Territory.

1.43

“Commercialization” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a given Licensed Product, including activities related to marketing, promoting, selling, distributing, seeking, obtaining, and maintaining Reimbursement Approvals, and importing and exporting such Licensed Product, launch preparation activities and interacting with Regulatory Authorities regarding any of the foregoing, but excluding, in each case (a) for clarity, interactions with Regulatory Authorities regarding Clinical Trials, obtaining Regulatory Approvals, and other Development activities (including for clarity Manufacturing activities related to Development) and (b) activities directed to Development, Manufacturing, or Medical Affairs. “Commercialize” and “Commercializing” shall have their correlative meanings.

1.44

“Commercialization Excess Costs” has the meaning set forth in the Pre-Tax Profit or Loss Schedule.

1.45

“Commercialization Permitted Overage” has the meaning set forth in the Section 8.3.5(c) (Overruns).

1.46

“Commercialization Plan” means the Global Strategic Launch Plan and the Joint Commercialization Plan.

1.47

“Commercialization Report” has the meaning set forth in Section 6.8 (Commercialization Reporting).

1.48

“Commercially Reasonable Efforts” means such efforts that are consistent with the efforts and resources normally used by GSK (in the case of GSK) or ITEOS (in the case of ITEOS) in the exercise of its reasonable business discretion relating to Development and Commercialization of a compound, antibody, or product owned by it or to which it has

exclusive rights, with similar characteristics as the applicable relevant Licensed Antibody and Licensed Product hereunder, that is of similar market potential at a similar stage in its development or product life as such Licensed Antibody or Licensed Product, taking into account issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position, the regulatory structure involved, profitability, and other relevant factors, including technical, legal, scientific or medical factors.  For purposes of clarity, it is anticipated that the level of effort may be different for different markets and may change over time, reflecting changes in the status of the product and the market(s) involved.

1.49

“Committed Development Spend” has the meaning set forth in Section 3.2.3 (Shared Development Costs).

1.50

“Committed Studies” has the meaning set forth in Section 3.2.1 (Global Development Plan).

1.51

“Committee” means, individually, the JSC, the JDC, the JCC and the Financial Working Group or any other Subcommittee established as set forth in Section 7.5 (Other Subcommittees).

1.52

“Committee Deadlock” has the meaning set forth in Section 7.7.1 (Committee Decision Making).

1.53

“Companion Diagnostic” means a product designed for use in a diagnostic biomarker assay tailored or optimized for use with a Licensed Product, for predicting or monitoring the suitability of such Licensed Product for prophylactic or therapeutic use in human patients or defined subpopulations thereof.  A Companion Diagnostic shall be intended for use (a) as a means to select or monitor the patient population for the conduct of clinical studies of such Licensed Product, (b) to predict predisposition to treatment in clinical use with such Licensed Product, or (c) to predict or monitor potential safety considerations in clinical use with such Licensed Product.  Use of a Companion Diagnostic to guide use of the Licensed Product will be contingent on appropriate Regulatory Approvals for such uses as deemed necessary by the FDA or other similar Regulatory Authority with appropriate jurisdiction.

1.54

“Competing Product” has the meaning set forth in Section 11.3.1 (Notification of Infringement).

1.55

“Compliance Officers” has the meaning set forth in Section 6.9.1 (Establishment of Compliance Program).

1.56

“Confidential Information” means any technical, business or other information provided by or on behalf of one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) in connection with this Agreement, whether prior to, on, or after the Effective Date, including under the CDA.

1.57

“Control” (including variations such as “Controlled,” “Controlling” and the like) means, (a) with respect to any Know-How, Patent, material, information or other intellectual property, the possession (whether by sole or joint ownership or license or otherwise, other than the licenses granted hereunder) of the ability to grant access, right to use, license or sublicense or other right to Exploit such Know-How, Patent, material, information or other intellectual property as set forth in this Agreement, or (b) with respect to any compound, antibody or product, the possession by a Party of the ability (whether by sole or joint ownership, license or otherwise, other than the licenses granted hereunder) to grant a license or sublicense under Patents that claim such compound, antibody or product or under Know-How that is used in connection with the Exploitation of such compound, antibody, or product, in each case ((a) and (b)), without violating the terms of any agreement or other arrangement with any Third Party, or any Applicable Law. Notwithstanding any provision to the contrary set forth in this Agreement, a Party and its Affiliates will not be deemed to “Control” any Know-How, Patent, material, information, other intellectual property, compound, antibody or product, that, prior to the consummation of a Change of Control of such Party, is owned or in-licensed by a Third Party (or an Affiliate of such Third Party) that becomes an Affiliate of such acquired Party after the Effective Date as a result of such Change of Control unless (i) prior to the consummation of such Change of Control, such acquired Party or any of its Affiliates also Controlled such Know-How, Patents, material, information, other intellectual property, compound, antibody or product, (ii) any such Know-How, Patents, material, information, other intellectual property, compound, antibody or product arise from participation by employees or consultants of such Third Party in any activities conducted under this Agreement after such Change of Control, or (iii) the Know-How, Patents, material, information, other intellectual property, compound, antibody or product, owned or in-licensed by such Third Party were not used in the performance of activities under this Agreement prior to the consummation of such Change of Control, but after the consummation of such Change of Control, such acquired Party or any of its Affiliates actually uses any such Know-How, Patents, material, information, other intellectual property, compound, antibody or product, in the performance of its obligations or exercise of its rights under this Agreement, in each of which cases ((i) through (iii)), such Know-How, Patents, material, information, other intellectual property, compound, antibody or product, will be deemed “Controlled” by such Party for purposes of this Agreement.

1.58

“Controlling Party” has the meaning set forth in Section 11.2.1 (Subject Patents).

1.59

“Cost Share End Date” has the meaning set forth in Section 6.7.3 (Effects of Opt-Out).

1.60

“Cost Share Start Date” has the meaning set forth in Section 8.3.1 (Pre-Tax Profit or Loss).

1.61

“Cover” or “Covered” or “Covering” means, with respect to a particular subject matter at issue and a relevant Patent, that the manufacture, use, sale, offer for sale, or importation of such subject matter would fall within the scope of one or more claims in such Patent.

1.62

“Currency Gains and Losses” means the gain or loss resulting from changes in exchange rates between the functional currency and the foreign currency in which the transaction is denominated, to the extent specifically identifiable to a Licensed Product for which costs are shared by the Parties hereunder and shall only include the currency gains and losses realized between the end of a Calendar Quarter and the date of invoice payment for that Calendar Quarter.

1.63

“Data” means pre-clinical data (including computational validation, genetic data (including genotype, phenotype and genetic sequencing data), in vitro and in vivo data), clinical data (including enrollment data, broad data sets, study and investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases), and regulatory, Manufacturing, biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, safety and quality control data, information and documentation, whether in written or electronic form.

1.64

“Data Protection Law” means all applicable laws, rules and regulations, including, to the extent applicable, the United States Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (“HIPAA”), the California Consumer Privacy Act of 2018 (“CCPA”), and any applicable 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.

1.65

“Data Security Breach” has the meaning set forth in Section 10.5 (Data Breach).

1.66

“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 Trial and study information, including anonymized patient level data, as such initiative is described on https://www.clinicalstudydatarequest.com/.

1.67

[***].

1.68

“Detail” or “Detailing” means, with respect to a Licensed Product, the communication made by a Sales Representative during a Sales Call (a) involving face-to-face contact or virtual meetings (such as through videoconference) with healthcare professionals, (b) describing in a fair and balanced manner the FDA-approved uses and other relevant characteristics of the Licensed Product being detailed, (c) using approved Promotional Materials in an effort to inform healthcare professionals on the Licensed Product for its FDA-approved uses in a manner consistent with Applicable Law, and (d) made at a healthcare professional’s office or other appropriate venues (including audio or video teleconference) conducive to pharmaceutical product informational communication where the principal objective is to place an emphasis on the Licensed Product with such healthcare professional.

1.69

“Development” means any and all research and development activities conducted that are necessary for developing, seeking, obtaining, or maintaining Regulatory Approvals for Licensed Products, which include pre-clinical studies and non-clinical studies, Clinical

Trials, quality of life assessments, translational research, Companion Diagnostic development, pharmacoeconomics, regulatory affairs, Manufacturing process development, formulation development and activities performed in support of the CMC (chemistry, manufacturing and controls, or equivalent) section of an IND or BLA and other Regulatory Filings, including all CMC Development.  For clarity, Development excludes Commercialization, Manufacturing, and Medical Affairs activities. “Develop” and “Developing” shall have their correlative meanings.

1.70

“Development and Filing Milestone” has the meaning set forth in Section 8.4 (Development and Filing Milestones).

1.71

“Development and Filing Milestone Payments” has the meaning set forth in Section 8.4 (Development and Filing Milestones).

1.72

“Development Costs” means the [***] incurred by a Party or its Affiliates, Sublicensees or subcontractors after the Effective Date in the performance of the respective Shared Global Development Activities of such Party [***] to the Development of a Licensed Product, to the extent incurred in accordance with the Global Development Plan and Global Development Budget. Development Costs include, to the extent set forth in the Global Development Plan and corresponding Global Development Budget (a) costs for other materials (e.g., non-Licensed Product comparator drugs and placebo obtained for use in Development of the Licensed Products), (b) all filing fees required for and other costs associated with, any Regulatory Filings for Licensed Products [***] (c) [***] (i) [***] (ii) CMC Development, [***] (d) Clinical Manufacture Costs, (e) Manufacturing Costs [***], (h) Patent Costs [***]. Development Costs excludes all costs incurred in connection with Commercialization of or performance of Medical Affairs activities [***] for Licensed Products. Development Costs do not include any costs or expenses incurred by GSK in connection with the performance of the GSK Sole Development Activities.

1.73

“Development Excess Costs” has the meaning set forth in Section 8.2.2(b) (Overruns).

1.74

“Development FTE Costs” means, as applicable with respect to any period, the FTE Rate for the performance of Development activities, multiplied by the actual total number of FTEs (or portion thereof) directly devoted to performing such Development activities in accordance with the Global Development Plan under this Agreement, during such period. The calculation of the number of FTEs for purposes of determining Development FTE Costs will be documented by the Parties in a manner designed to ensure proper reporting and auditing of such information in accordance with this Agreement.

1.75

“Development Program” has the meaning set forth in Section 7.2.1 (Establishment of the JDC).

1.76

“Development Reports” has the meaning set forth in Section 3.6 (Development Reporting).

1.77

“Disclosing Party” has the meaning set forth in Section 1.56 (Confidential Information).

1.78

“Dispute” has the meaning set forth in Section 16.1 (Dispute Resolution).

1.79

“Dollars” or “$” means the official currency of the United States of America.

1.80

“DOJ” has the meaning set forth in Section 2.2 (HSR Filing).

1.81

“Effective Date” has the meaning set forth in Section 2.1 (Effectiveness of the Agreement).

1.82

“EMA” means the European Medicines Agency, or any successor entity thereto performing similar functions for the European Union.

1.83

“Entity” has the meaning set forth in Section 8.10.4 (No Partnership).

1.84

“EOS-448 Antibody” means the antibody targeting TIGIT known internally by ITEOS as EOS-448, the structure of which is set forth on Schedule 1.84.

1.85

“EOS-448 Sole Active Product” means the pharmaceutical product that contains a Licensed Antibody as the sole active ingredient, in all forms, presentations, strengths, doses and formulations.

1.86

“European Data Protection Laws” means the General Data Protection Regulation 2016/679, the e-Privacy Directive 2002/58/EC, the e-Privacy Regulation 2017/003 once it takes effect, and any relevant law, statute, declaration, decree, directive, legislative enactment, order, ordinance, regulation, rule or other binding instrument that implements, replaces, adds to, amends, extends, reconstitutes or consolidates such laws from time to time, including the Data Protection Act 2018 of the United Kingdom, in each case as amended, consolidated, re-enacted or replaced from time to time.

1.87

“European Union” means the economic, scientific and political organization of member states in Europe, as it may be constituted from time to time, and notwithstanding any provision to the contrary set forth in this Agreement, will include the United Kingdom for purposes of this Agreement.

1.88

“Excluded Commercialization Activities” has the meaning set forth in Section 1.236 (Shared Commercialization Activities).

1.89

“Exclusive Sublicense” has the meaning set forth in Section 9.3 (Sublicenses).

1.90

“Execution Date” has the meaning set forth in the preamble.

1.91

“Existing CMO” means [***].

1.92

“Existing CMO Agreement” has the meaning set forth in Section 5.1.2 (Clinical Supply).

1.93

“Expansion” has the meaning set forth in Section 1.203 (Phase 2 Adaptive Study).

1.94

“Exploit” means Develop, have Developed, make, have made, use, have used, perform Medical Affairs, have performed Medical Affairs, offer for sale, have offered for sale, sell, have sold, export, have exported, import, have imported, Manufacture, have Manufactured, Commercialize, have Commercialized or otherwise exploit. “Exploitation” and “Exploiting” will be construed accordingly.

1.95

“FDA” means the U.S. Food and Drug Administration, or any successor entity thereto performing similar functions in the United States.

1.96

“Field” means any use or purpose, including the treatment, palliation, diagnosis or prevention of any human or animal disease.

1.97

“Financial Report” has the meaning set forth in Section 8.3.2 (Reporting Generally).

1.98

“Financial Working Group” has the meaning set forth in Section 7.4 (Financial Working Group).

1.99

“First Commercial Sale” means, with respect to a given Licensed Product in a country, the first commercial sale in an arms-length transaction of such Licensed Product by or on behalf of GSK, its Affiliate or Sublicensee in such country following receipt of applicable Regulatory Approval of such Licensed Product in such country; provided, however, that First Commercial Sale shall not include any transfer of a product (a) between or among GSK and its Affiliates or its Sublicensees, unless the Affiliate or Sublicensee is the last entity in the distribution chain of such product, or (b) for purposes of patient assistance programs, treatment IND sales, named patient sales or compassionate use sales, provided, that in case of (b), such product is sold at a price no greater than GSK’s Manufacturing Costs for such Licensed Product.

1.100

“First No Opt-Out Period” means, with respect to a Licensed Product, the time period commencing on the Effective Date and ending on [***].

1.101

“Force Majeure” means any event beyond the reasonable control of the affected Party, including: embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics (including pandemics), the spread of infectious diseases, and quarantines; fire, floods, earthquakes or other acts of nature; impossibility to obtain materials, components, drug substance, utilities, equipment, supplies, fuel or other required materials, receipt of warning letters, or loss, infection or failure of cell banks (in each case, due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party); or acts, omissions, or delays in acting by any Governmental Authority (including the refusal of any Regulatory Authority to issue required Regulatory Approvals due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party), and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). The Parties agree the effects of the COVID-19 pandemic that is ongoing

as of the Effective Date (including related government orders) may be invoked as a Force Majeure for the purposes of this Agreement even though the pandemic is ongoing and those effects may be reasonably foreseeable (but are not known for certain) as of the Effective Date. In addition, a Force Majeure may include reasonable measures affirmatively taken by a Party or its Affiliates to respond to any epidemic, pandemic, or spread of infectious disease (including the COVID-19 pandemic), such as requiring employees to stay home, closures of facilities, delays of Clinical Trials, or cessation of activities in response to an epidemic or other Force Majeure event.

1.102

“FTC” has the meaning set forth in Section 2.2 (HSR Filing).

1.103

“FTE” means, with respect to employees of a Party or its Affiliates, the equivalent of the work of one (1) full time person for one (1) year (consisting of at least [***] hours per year).  Overtime, and work on weekends, holidays and the like shall not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution.  If any person works partially on other work in a given Calendar Year, then the full-time equivalent to be attributed to such person’s work hereunder shall be equal to the percentage of such person’s total work time in such Calendar Year that such person spent working on activities contemplated under this Agreement.  FTE efforts shall not include the work of general corporate personnel.  Each Party shall track FTEs of its personnel using such Party’s standard practices and methodologies and in a manner designed to ensure proper reporting and auditing of such information in accordance with this Agreement.

1.104

“FTE Rate” means, unless otherwise agreed by the unanimous decision of the Financial Working Group or by the Parties in writing, commencing on the Effective Date, (a) with respect to Development activities, [***] per FTE and (b) with respect to Commercialization activities at a rate to be agreed by the Financial Working Group prior to commencement of Commercialization activities by either Party. The FTE Rate shall be increased or decreased on the first day of every January starting in 2023 by a percentage equivalent to the change over the preceding twelve (12)-month period in the Consumer Price Index for All Urban Consumers (All Items), or any successor to such published measure, not seasonally adjusted, as published by the U.S. Department of Labor Bureau of Labor Statistics.  For clarity, the FTE Rate includes “fully burdened” base salary, target bonus (yearly bonus based on achievement of personal/corporate targets), plus benefits including holiday allowance, pension, medical, risk, share-based payments and other remuneration-based benefits, tax and social security; however, the FTE Rate does not include or cover costs for facilities, travel expenses and IT allocation.

1.105

“GAAP” means generally acceptable accounting standards, principles, and procedures as issued by the Financial Accounting Standards Board (FASB).

1.106

“GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (a) FDA regulations and guidelines for good clinical practice, as promulgated by the FDA under 21 CFR Parts 50, 54, 56, 312 and 812, (b) as set forth in European Commission Directive 2001/20/EC relating to the implementation of good

clinical practice in the conduct of clinical trials on medicinal products for human use, and brought into law by European Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice for investigational medicinal products, (c) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the EU, (d) the Declaration of Helsinki (2008), and (e) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which clinical studies of a product are conducted.

1.107

“Global Development Budget” means the budget of all [***] to be incurred from and after the Effective Date in the performance of any Shared Global Development Activities under the Global Development Plan for any Licensed Antibodies and Licensed Products, including (a) a budget, broken down by Calendar Quarters and at a level of detail agreed by the JDC, for the estimated [***] expected to be incurred by each Party in the given Calendar Year with respect to such Shared Global Development Activities under the Global Development Plan and (b) for subsequent Calendar Years, a [***], of the estimated [***] to be incurred in connection with such Shared Global Development Activities under the applicable Global Development Plan [***] for such Licensed Antibodies and Licensed Products. The Global Development Budget will not include any costs or expenses to be incurred by GSK in connection with the performance of the GSK Sole Development Activities.

1.108

“Global Development Plan” means the written plan setting forth (a) (i) all Development activities (including Clinical Trials) for any Licensed Antibodies and Licensed Products (including Combination Products), in each case, through the completion of Registration Studies and any other Development activities necessary to obtain and maintain Regulatory Approvals for such Licensed Products in the U.S. and the European Union, including process development activities, CMC activities, formulation development, Companion Diagnostic development, and any post-Regulatory Approval studies and other non-clinical and pre-clinical studies and Clinical Trials, activities related to value-evidence outcomes, patient-focused outcomes and epidemiology, in each case, the data from which may be used to obtain or maintain Regulatory Approval in both the U.S. and the European Union (the activities described in this clause (a)(i), the “Shared Global Development Activities”), and (ii) all Development activities (including Clinical Trials), other than activities described in the foregoing clause (a)(i), that are necessary or desirable to obtain and maintain Regulatory Approvals of each Licensed Product in the Net Sales Territory, including all proposed post-Regulatory Approval studies and all other non-clinical and pre-clinical studies and Clinical Trials, activities related to value-evidence outcomes, patient-focused outcomes and epidemiology, in each case, the data from which will be used solely to obtain or maintain Regulatory Approval in the Net Sales Territory (the activities described in this clause (a)(ii), the “GSK Sole Development Activities”), (b) the estimated timelines for the performance and completion of such activities described in clause (a), (c) the regulatory strategy for obtaining and maintaining Regulatory Approval for Licensed Products in the Territory, (d) the supplies of Licensed Antibodies and Licensed Products (or components thereof including Other Components Controlled by GSK), comparator

drugs and placebo, in each case, needed to perform such Development activities, and (e) the Global Development Budget, in each case ((a) through (e)), as the same may be amended from time-to-time in accordance with this Agreement. The initial Global Development Plan is attached as Schedule 3.2 of this Agreement.

1.109

“Global Strategic Launch Plan” has the meaning set forth in Section 6.1 (Global Strategic Launch Plan).

1.110

“GLP” means all applicable Good Laboratory Practice standards, including, as applicable: (a) FDA regulations and guidelines for good laboratory practice, as promulgated by the FDA under 21 CFR Part 58; (b) European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices, as may be amended from time to time as well as any Rules Governing Medicinal Products in the European Community Vol. III, ISBN 92.825 9619-2 (ex-OECD principles of GLP); and (c) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which pre-clinical or clinical studies of a product are conducted.

1.111

“GMP” means all applicable Good Manufacturing Practices, including: (a) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice; (b) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601, 610 and 820; (c) the Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products; (d) the principles detailed in the ICH Q7A guidelines; and (e) the equivalent Applicable Laws in any relevant country, each as may be amended and applicable from time to time.

1.112

“Government Official” (where “government” means all levels and subdivisions of governments, i.e., local, regional, national, administrative, legislative, executive, or judicial, and royal or ruling families) 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 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 individual 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; or (e) any individual acting in an official capacity for or on behalf of any of the above.  “Government Official” includes any individual with close family members who are Government Officials (as defined above) with the capacity, actual or perceived, to influence or take official decisions affecting the business of a Party.

1.113

“Governmental Authority” means any multinational, federal, national, state, provincial, local or other entity, office, commission, bureau, agency, political subdivision, instrumentality, branch, department, authority, board, court, arbitral or other tribunal, official or officer, exercising executive, judicial, legislative, police, regulatory, administrative or taxing authority, or functions of any nature pertaining to government.

1.114

“GSK” has the meaning set forth in the preamble.

1.115

“GSK Arising Know-How” has the meaning set forth in Section 11.1.3 (Ownership by GSK).

1.116

“GSK Arising Patents” has the meaning set forth in Section 11.1.3 (Ownership by GSK).

1.117

“GSK Arising Technology” means GSK Arising Know-How and GSK Arising Patents.

1.118

“GSK Background Know-How” means any Know-How Controlled by GSK or its Affiliates as of the Effective Date or during the Term, other than pursuant to this Agreement.

1.119

“GSK Background Patents” means any Patents Controlled by GSK or its Affiliates as of the Effective Date or during the Term, other than pursuant to this Agreement.

1.120

“GSK Background Technology” means the GSK Background Know-How and the GSK Background Patents.

1.121

“GSK CMO Agreement” has the meaning set forth in Section 5.1.5 (Second Source).

1.122

“GSK Indemnitees” has the meaning set forth in Section 15.1.1 (Indemnification by ITEOS).

1.123

“GSK Patents” has the meaning set forth in Section 11.2.3 (GSK Patent Prosecution and Costs).

1.124

“GSK Sole Development Activities” has the meaning set forth in Section 1.108 (Global Development Plan).

1.125

“GSK Technology” means (a) all GSK Background Technology, (b) all GSK Arising Technology Controlled by GSK or any of its Affiliates during the Term, and (c) GSK’s joint ownership interest in Joint Arising Technology Controlled by GSK during the Term, in each case ((a) through (c)), that [***] and the terms of this Agreement.  

1.126

“Guidelines” has the meaning set forth in Section 6.9.3 (Applicable Laws and Guidelines).

1.127

“HSR Act” has the meaning set forth in Section 2.2 (HSR Filing).

1.128

“HSR Clearance Date” has the meaning set forth in Section 2.2 (HSR Filing).

1.129

“HSR Filings” has the meaning set forth in Section 2.2 (HSR Filing).

1.130

“Human Biological Samples” means any human biological material (including any derivative or progeny thereof), including any portion of an organ, any tissue, skin, bone, muscle, connective tissue, blood, cerebrospinal fluid, cells, gametes, or sub-cellular structures such as DNA, or any derivative of such biological material such as stem cells or cell lines; and any human biological product, including hair, nail clippings, teeth, urine, feces, breast milk and sweat.

1.131

“IFRS” means the International Financial Reporting Standards as adopted by the United Kingdom, applied on a consistent basis.

1.132

“Increased Withholding Taxes” has the meaning set forth in Section 8.10.2 (Tax Matters).

1.133

“IND” means an Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 CFR Part 312, or any equivalent filing with any relevant Regulatory Authority in any jurisdiction.

1.134

“Indemnifying Party” has the meaning set forth in Section 15.1.3 (Indemnification Procedures).

1.135

“Indemnitee” has the meaning set forth in Section 15.1.3 (Indemnification Procedures).

1.136

“Indication” means a separate and distinct disease, disorder or medical condition that a Licensed Product is intended to treat, prevent, cure or ameliorate in the indications section of the Approved Labeling for such Licensed Product, or that is the subject of a Clinical Trial and where it is intended that the data and results of such Clinical Trial (if successful) will be used to support a Regulatory Filing and Regulatory Approval that is intended to result in distinct labeling in the indications section of the Approved Labeling relevant to usage of such Licensed Product in such disease, disorder or medical condition that is separate and distinct from another disease, disorder, or medical condition. For clarity, each different patient population or line of therapy will be deemed a different Indication.

1.137

“Infringement” has the meaning set forth in Section 11.3.1 (Notification of Infringement).

1.138

“Infringement Notice” has the meaning set forth in Section 11.3.1 (Notification of Infringement).

1.139

“Initiation” means, with respect to any Clinical Trial, the first patient dosed for the first time in such Clinical Trial.

1.140

“Institutional Review Board” means an institutional review board (“IRB”) or independent ethics committee (“IEC”) that reviews the methods proposed for research and development activities to ensure such methods satisfy ethical requirements.

1.141

“Internal Policies” means, with respect to a Party, such Party’s health care compliance, ethical, reputational, anti-bribery and corruption and other policies applicable to such Party’s activities under this Agreement, and any standard operating procedures implementing such policies, including the codes of conduct of any self-regulatory body of which that Party is a member.

1.142

“ITEOS” has the meaning set forth in the preamble.

1.143

“ITEOS [***] Agreement” means that certain [***].

1.144

“ITEOS Arising Know-How” has the meaning set forth in Section 11.1.4 (Ownership by ITEOS).

1.145

“ITEOS Arising Patents” has the meaning set forth in Section 11.1.4 (Ownership by ITEOS).

1.146

“ITEOS Arising Technology” means ITEOS Arising Know-How and ITEOS Arising Patents.

1.147

“ITEOS Background Agreements” means, collectively: [***].

1.148

“ITEOS Background Know-How” means any Know-How Controlled by ITEOS or its Affiliates as of the Effective Date or during the Term, other than pursuant to this Agreement.

1.149

“ITEOS Background Patents” means any Patents Controlled by ITEOS or its Affiliates as of the Effective Date or during the Term, other than pursuant to this Agreement.

1.150

“ITEOS Background Technology” means the ITEOS Background Know-How and the ITEOS Background Patents.

1.151

“ITEOS Indemnitees” has the meaning set forth in Section 15.1.2 (Indemnification by GSK).

1.152

“ITEOS Phase 1 Clinical Study” means IO-002 Study that is a multicenter, open-label, dose-escalation Phase I/IIa clinical study to evaluate the safety and tolerability, PK, PD, and antitumor activity of EOS884448 in participants with advanced cancers (ClinicalTrials.gov Identifier: NCT04335253).

1.153

“ITEOS Retained Rights” has the meaning set forth in Section 9.1 (License Grant to GSK).

1.154

“ITEOS Technology” means (a) all ITEOS Background Technology, (b) all ITEOS Arising Technology Controlled by ITEOS or any Affiliate during the Term, and (c) ITEOS’s interest in Joint Arising Technology Controlled by ITEOS during the Term, in each case ((a) through (c)), that are [***].  

1.155

“Joint Arising Technology” has the meaning set forth in Section 11.1.5 (Joint Ownership).

1.156

“Joint Commercialization Budget” has the meaning set forth in Section 6.2 (Joint Commercialization Plans).

1.157

“Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 7.3.1 (Establishment of JCC).

1.158

“Joint Commercialization Plan” has the meaning set forth in Section 6.2 (Joint Commercialization Plans).

1.159

“Joint Development Committee” or “JDC” has the meaning set forth in Section 7.2.1 (Establishment of the JDC).

1.160

“Joint Steering Committee” or “JSC” has the meaning set forth in Section 7.1.1 (Establishment of JSC).

1.161

“Know-How” means any information or materials, whether proprietary or not and whether patentable or not, including confidential trade secrets, models, discoveries, inventions, ideas, Data and other types of data, databases, results, assays, instructions, processes, techniques, documentation, equipment, technology, quality control analysis, specifications, transportation and storage requirement, concepts, methods, procedures, designs, compositions, plans, documents, formulas, algorithms, Materials, inventions, computational models, human-relevant disease models, computer software (including source code), predictive model implementations, data analytic tools, biotechnology hardware and associated algorithms and methodologies, methods of use, expert knowledge and information.

1.162

“Knowledge of ITEOS” or “ITEOS’s Knowledge” means the actual knowledge by ITEOS’s senior management [***].  For this purpose, “senior management” means ITEOS’s officers as defined under Rule 16a-1(f) of the Securities Exchange Act of 1934 (or amendment thereto or replacement or successor law) as of the Execution Date.

1.163

“Licensed Antibody” means (a) the EOS-448 Antibody and (b) any other [***] in each case ((a) and (b)), that have been generated by or on behalf of ITEOS.

1.164

“Licensed Product” means any pharmaceutical product that is comprised of or contains a Licensed Antibody, in all forms, presentations, strengths, doses and formulations, and includes the EOS-448 Sole Active Product and Combination Products.

1.165

“Losses” has the meaning set forth in Section 15.1.1 (Indemnification by ITEOS).

1.166

“Manufacture” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, serialization, labeling, shipping, and holding of any product, or any component or intermediate thereof, including process qualification and validation, scale-up, qualification, validation, pre-clinical, clinical and commercial capacity reservation, production, and analytic development, product characterization, stability testing, quality assurance, and quality control, but, in each case, excluding activities directed to Development, Medical Affairs, or Commercialization. “Manufacturing” shall have a correlative meaning.

1.167

“Manufacturing Cost” means:

1.167.1

With respect to GSK as the Manufacturing Party, with respect to a Licensed Product or other compound, antibody, or product Controlled by GSK and supplied to ITEOS pursuant to this Agreement, GSK’s reasonable and necessary Standard Costs of Goods Manufactured plus Cost Variances and a standard manufacturing markup of [***] to cover the costs of global shared services for support activities such as quality, procurement, information technology, human resource, and finance, determined in accordance with applicable Accounting Standards, and the terms and conditions of this Agreement, incurred in Manufacturing or acquisition of such Licensed Product, in each case, to the extent directly attributable and reasonably allocable (subject to discussion and agreement by the Financial Working Group) to such Licensed Product or other compound, antibody, or product Controlled by GSK, which shall include the following costs incurred by a Party or its Affiliates:

(a)

“Standard Cost of Goods Manufactured” are, as calculated in accordance with applicable Accounting Standards, consistently applied by the Manufacturing Party in accordance with its standard accounting practice for public financial reporting purposes, budgeted unit costs of direct materials, direct labor, Third Party fees, depreciation of Manufacturing equipment (including buildings, fixtures, and fittings and a reasonable allocation of indirect expenses and overhead connected therewith (to the extent allocable to forecasted production of materials for use in or sale of such product recorded as an expense by GSK or its Affiliates)), which allocation is made in a manner consistent with such allocations applied to other products made in the same production center, and consistent with customary practice. Examples of reasonably allocable indirect manufacturing costs include power, rent and rates, quality, and regulatory; and

(b)

“Cost Variances” are actual costs of Manufacturing versus Standard Cost of Goods Manufactured and include direct materials variances (including material usage variances and purchase price variances), direct labor variances, and indirect expenses and overhead variances (to the extent allocable to forecasted production of materials for use in or sale of such product recorded as an expense by GSK or its Affiliates), which allocation is made in a manner consistent with customary practice (including volume variances, variable overhead spending variances and fixed overhead spending variances).

1.167.2

To the extent Licensed Products or other compounds, antibodies, or products Controlled by GSK are Manufactured by Third Party contract manufacturing organizations and similar contractors (collectively, “CMOs”), the Out-of-Pocket Costs invoiced by and paid to such CMO(s) for the Manufacture of such product, plus a Manufacturing mark-up of [***].

1.167.3

With respect to ITEOS as the Manufacturing Party, (a) for such Licensed Product (or components thereof) Manufactured by a Third Party, the Out-Of-Pocket Costs paid by ITEOS or its Affiliates to a Third Party for Manufacturing of such Licensed Product, or any component thereof; and (b) for such Licensed Product (or components thereof) Manufactured by ITEOS or its Affiliates, the reasonable internal costs and direct Out-of-Pocket Costs recorded as an expense by ITEOS or its Affiliates in connection with the Manufacture, including supply chain management, of such Licensed Product, in each case ((a) and (b)), plus a Manufacturing mark-up of [***].

1.168

“Manufacturing Tech Transfer Plan” has the meaning set forth in Section 5.2 (Manufacturing Technology Transfer).

1.169

“Marketing Approval Application” or “MAA” means a BLA or any corresponding application in the applicable country or jurisdiction outside of the United States, including, with respect to the European Union, an application for Regulatory Approval filed with the EMA pursuant to the centralized approval procedure or with the applicable national Regulatory Authority of a country in the European Union with respect to the mutual recognition procedure, decentralized procedure or any other national approval.

1.170

“Marketing Materials” means Promotional Materials, Regulatory Filings relating to Promotional Materials, and training program and related materials contemplated by Section 6.10.4 (Product Specific Training).

1.171

“Material Safety or Commercialization Concern” means, with respect to an activity for a Licensed Antibody or Licensed Product, that such activity may [***].

1.172

“Materials” means any chemical or biological substances, including any biological or chemical compounds, drug products, Human Biological Samples, or other materials, regardless of the route of transfer, that are supplied by a Party or its nominee to the other Party or its nominee for use in the conduct of activities under this Agreement, including activities set forth in the Global Development Plan.

1.173

“Materials Receiving Party” has the meaning set forth in Section 3.12.1 (Material Transfers).

1.174

“Materials Transferring Party” has the meaning set forth in Section 3.12.1 (Material Transfers).

1.175

“Medical Affairs” means, with respect to a product, any and all activities performed by or on behalf of a Party’s or its Affiliates’ medical affairs departments interacting with physicians or other healthcare professionals who may utilize or conduct research related to a drug or biological product, including: supporting continuing medical education and other medical programs and communications; Health Economics and Outcomes Research (HECOR, HEMAR); pharmacovigilance, publication and dissemination of publications; fulfillment of medical information responses to external inquiries or complaints; development and execution of disease awareness education including symposia and digital education initiatives; sponsorship and booth exhibition at key congresses; natural history and real world evidence studies; supporting educational fellowships and research grants, scientific research agreements and investigator initiated trials (following Regulatory Approval); medical resourcing, training and allocation; medical and scientific platform and content development; conducting appropriate activities involving opinion leaders (including communications and engagement); conducting medical science liaison activities; advisory boards or other consulting programs (to the extent related to medical affairs or clinical guidance); field based medical science liaisons, medical affairs clinical trial management, medical doctors in field (separate from medical science liaisons); establishing patient registries and expanded access programs; life cycle management activities and clinical research.

1.176

“Medical Affairs Content” means all written, printed, graphic, electronic, audio or video matter, in each case, intended for use or used by a Party or its Affiliates, Sublicensees or subcontractors in connection with the conduct of Medical Affairs activities related to the Licensed Products in the Profit-Sharing Territory.

1.177

“Medical Affairs Materials” means the Medical Affairs Content, Regulatory Filings relating to Medical Affairs Content, and training program and related materials contemplated by Section 6.4.4 (Medical Affairs Training).

1.178

“More Conservative Approach” means the approach or position described in the written proposal provided by a Party’s Senior Executive to the Designated Executives with respect to the resolution of a Committee Deadlock regarding a Material Safety or Commercialization Concern, which approach or position, in the aggregate, [***].  

1.179

“MTR” has the meaning set forth in Section 3.12.1 (Material Transfers).

1.180

“Negotiation Period” has the meaning set forth in Section 3.5.3 (Limitation On Third Party Combinations).

1.181

“Net Sales” means, with respect to a Licensed Product during a stated time period, the gross invoiced sales amounts for such Licensed Product sold by or on behalf of GSK, its Affiliates or Sublicensees in arm’s length transactions to Third Parties (but not including sales relating to transactions by and between GSK, its Affiliates or Sublicensees unless the Affiliate or Sublicensee is the last entity in the distribution chain of such Licensed Product) less the following deductions from such gross amounts which are actually incurred, allowed, paid, accrued or specifically allocated to the extent that such amounts are deducted from gross invoiced sales amounts as reported by GSK in its financial statements in accordance with IFRS, applied on a consistent basis:

1.182

“Net Sales Territory” means the Territory excluding the Profit-Sharing Territory; provided, that from and after the Cost Share End Date, “Net Sales Territory” means the entire Territory (including the U.S.).

1.183

“Non-Breaching Party” has the meaning set forth in Section 12.3.1 (Termination for Material Breach).

1.184

“Notice of Dispute” has the meaning set forth in Section 16.1.1 (Dispute Resolution).

1.185

“Notice Period” has the meaning set forth in Section 3.5.3 (Limitation On Third Party Combinations).

1.186

“[***] Agreement” means that certain [***].

1.187

“October 2021 Campaign” has the meaning set forth in Section 5.1.2 (Clinical Supply).

1.188

“OIG” has the meaning set forth in Section 6.9.3 (Applicable Laws and Guidelines).

1.189

“OPDP” means the FDA’s Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) or its successor entity.

1.190

“Opt-Out Notice” has the meaning set forth in Section 6.7.1 (ITEOS Opt-Out Right).

1.191

“Other Component(s)” has the meaning set forth in Section 1.41 (Combination Product).

1.192

“Out-Of-Pocket Costs” means the actual amounts paid by a Party or its Affiliate to a Third Party for specific external activities conducted for the Licensed Antibodies or Licensed Products.

1.193

“Party” or “Parties” has the meaning set forth in the preamble.

1.194

“Patent Challenge” has the meaning set forth in Section Error! Reference source not found. (Termination for Patent Challenge).

1.195

“Patent Costs” means all out-of-pocket expenses (including reasonable attorneys’ fees) incurred in the preparation, prosecution, filing and maintenance of Patents.

1.196

“Patent Liaisons” has the meaning set forth in Section 7.9 (Patent Liaisons).

1.197

“Patents” means all patents and pending patent applications (including inventor’s certificates and utility models) and any patents issuing therefrom, in any country in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisional and other continuing applications, supplementary protection certificates, renewals, and any and all reissues, extensions, registrations, reexaminations, confirmations, registrations and patents of addition on any of the foregoing.

1.198

“Payee” has the meaning set forth in Section 8.10.2 (Tax Matters).

1.199

“Payor” has the meaning set forth in Section 8.10.2 (Tax Matters).

1.200

“Permitted Overage” has the meaning set forth in Section 8.2.2(a) (Overruns).

1.201

“Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

1.202

“Personally Identifiable Information (PII)” means information that can be used to identify an individual, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual, which may include (alone or in combination): (a) a first and last name; (b) a home or other physical address, including street name and name of city or town; (c) an email address or other online contact information, such as an instant messaging user identifier or a screen name that reveals an individual’s email address; (d) a telephone number; (e) a social security number; (f) a bank, loan, or credit card account number; (g) a persistent identifier, such as a customer number held in a “cookie” or processor serial number, that is combined with other available data that identifies an individual consumer; or (h) any information that is combined with any of (a) through (g) above.

1.203

“Phase 2 Adaptive Study” means a Phase 2 Clinical Study that is not considered a Registration Study until it meets the criteria set within the protocol to expand to become a Registration Study at the pre-defined interim analysis (such meeting of such criteria, the “Expansion”).

1.204

“Phase 2 Clinical Study” means a Clinical Trial of an investigational product in subjects with the primary objective of characterizing its activity in a specific disease state as well as generating more detailed safety, tolerability, pharmacokinetics, pharmacodynamics, and dose finding information as described in 21 C.F.R. 312.21(b), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the Unites States.

1.205

“PhRMA” has the meaning set forth in Section 6.9.3 (Applicable Laws and Guidelines).

1.206

“PhRMA Code” has the meaning set forth in Section 6.9.3 (Applicable Laws and Guidelines).

1.207

“Potential In-License” has the meaning set forth in Section 9.11.2 (Potential In-License).

1.208

“Pre-Tax Profit or Loss” has the meaning set forth in the Pre-Tax Profit or Loss Schedule.

1.209

“Pre-Tax Profit or Loss Schedule” means the schedule set forth in Schedule 8.3.1 attached hereto.

1.210

“Product Claims” means a notice, claim, demand, suit or cause of action alleging or relating to, in whole or in part, bodily injury or personal injury arising from any act or omission connected with the Manufacture, Development, Commercialization or use of a Licensed Product in the Profit-Sharing Territory, including relating to alleged defects in the applicable Licensed Product resulting from an alleged intrinsic or latent problem or defect in the efficacy or safety of such Licensed Product.

1.211

“Product Marks” means the trademarks for use in connection with the Commercialization of any Licensed Product, including trademarks, generic names, international nonproprietary names, trade dress, style of packaging and Internet domain names used in connection with the Commercialization of such Licensed Product.

1.212

“Product Training Materials” has the meaning set forth in Section 6.10.4 (Product Specific Training).

1.213

“Profit-Sharing Term” means the Term, unless and until the Cost Share End Date occurs.

1.214

“Profit-Sharing Territory” means the United States, unless and until the Cost Share End Date occurs.

1.215

“Promotional Materials” means all written, printed, graphic, electronic, audio or video matter, including journal advertisements, sales visual aids, reprints, direct mail, direct-to-consumer advertising, and digital technologies including Internet and social media postings, Internet sites, email and broadcast advertisements, in each case, intended for use or used by either Party or its Affiliates, Sublicensees or subcontractors in connection with any advertising, marketing or promotion of the Licensed Products or a disease state related to the Licensed Products.

1.216

“Proof of Concept Trial” means a Clinical Trial that is designed to establish, for (a) a Licensed Product as part of a Co-Administration Therapy, or (b) a Licensed Product in a particular Indication, in each case ((a) and (b)), safety and initial evidence of efficacy that would be supportive of moving forward with additional Clinical Trials for such Licensed Product as part of such a Co-Administration Therapy, or for such Licensed Product in such Indication, as applicable.

1.217

“Proposed Additional Development” has the meaning set forth in Section 3.4.1 (Additional Development Proposals).

1.218

“Publication Strategy” has the meaning set forth in Section 10.8.1 (Publication Strategy).

1.219

“R&D Compliance Officer” has the meaning set forth in Section 3.13 (R&D Ethics & Compliance).

1.220

“Receiving Party” has the meaning set forth in Section 1.56 (Confidential Information).

1.221

“Registration Study” means, with respect to a given Licensed Product, any pivotal Clinical Trial of such Licensed Product designed to establish safety and efficacy of such Licensed Product in patients with the disease or condition being studied for purposes of filing a BLA with the FDA or, with respect to a jurisdiction other than the United States, a similar clinical trial for the purpose of enabling the filing of a Marketing Approval Application equivalent to a BLA with the applicable Regulatory Authority(ies) in such jurisdiction.  

1.222

“Regulatory Approval” means, with respect to a Licensed Product in a particular regulatory jurisdiction in the Territory, all approvals, licenses, registrations or authorizations of any Regulatory Authority, necessary for the Manufacturing, use, storage, import, export, transport, or Commercialization of such Licensed Product in such jurisdiction, including approval of the Marketing Approval Application for such Licensed Product in such jurisdiction.

1.223

“Regulatory Authority” means the FDA, the EMA or any regulatory body with similar regulatory authority in any other jurisdiction anywhere in the world.

1.224

“Regulatory Exclusivity” means, with respect to a particular Licensed Product in a country in the Territory, exclusive marketing rights conferred by a Regulatory Authority in such country with respect to such Licensed Product, excluding any rights in such country conferred by or based on any Patents.

1.225

“Regulatory Filing” means any filing, registration, or regulatory application or submission filed with a Regulatory Authority, including authorizations, approvals, Marketing Approval Applications, Regulatory Approvals, or clearances arising from the foregoing, and all notifications, communications, correspondence made to, received from, or otherwise conducted with a Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with such Regulatory Authority, in each case related to Exploiting a pharmaceutical or biologic product in a particular country or jurisdiction.

1.226

“Regulatory Responsible Party” has the meaning set forth in Section 4.1.3 (Regulatory Responsibilities).

1.227

“Reimbursement Approval” means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for biopharmaceutical products that a pharmaceutical or biologic product will be reimbursed by the Governmental Authorities or Regulatory Authorities in the Territory or any other approvals related to pricing, reimbursement or access to a pharmaceutical or biologic product (including all activities related to tenders and contracts).

1.228

“ROW Net Sales Milestones” has the meaning set forth in Section 8.5.1 (ROW Net Sales Milestones).

1.229

“ROW Net Sales Milestone Payments” has the meaning set forth in Section 8.5.1 (ROW Net Sales Milestones).

1.230

“Royalty Term” has the meaning set forth in Section 8.7.1 (Net Sales Royalties).

1.231

“Sales Call” means a personal visit (whether by face-to-face contact or virtual meetings (such as through videoconference)) by a Sales Representative to (a) one or more healthcare professional(s) having prescribing authority, or (b) key opinion leaders or “thought leaders” that are respected individuals that through their professional status have significant impact or influence on prescribing decisions, in each case ((a) and (b)), with the purpose of promoting the Licensed Product in order to cause such healthcare professional, opinion leader, or thought leader to prescribe such Licensed Product.

1.232

“Sales Representatives” means pharmaceutical sales representatives employed or contracted for by a Party or its Affiliates to conduct Detailing and other marketing efforts with respect to the Licensed Products in accordance with the terms of this Agreement.

1.233

“Second No Opt-Out Period” means, with respect to a Licensed Product, the time period commencing on the date that is [***] after the first filing date of a BLA in the U.S. for such Licensed Product and ending [***] following the First Commercial Sale of such Licensed Product in the Territory.

1.234

“Selected Product” has the meaning set forth in Section 9.12.1 (Mutual Exclusivity Covenant).

1.235

“Senior Executive” has the meaning set forth in Section 16.1.1 (Dispute Resolution).

1.236

“Shared Commercialization Activities” means all Commercialization activities that the Parties intend to conduct with respect to the Licensed Product in the Profit-Sharing Territory during the Profit-Sharing Term, including activities related to [***]. Shared Commercialization Activities exclude [***] (collectively, (a) through (f), the “Excluded Commercialization Activities”).

1.237

“Shared Global Development Activities” has the meaning set forth in Section 1.108 (Global Development Plan).

1.238

“Subcommittee” has the meaning set forth in Section 7.5 (Other Subcommittees).

1.239

“Subcommittee Deadlock” has the meaning set forth in Section 7.7.1 (Committee Decision Making).

1.240

“Subject Patents” has the meaning set forth in Section 11.2.1 (Subject Patents).

1.241

“Sublicensee” has the meaning set forth in Section 9.3 (Sublicenses).

1.242

“Target” means T cell immunoreceptor with Ig and immunoreceptor tyrosine-based inhibition motif domains (also known or referred to as TIGIT).

1.243

“Target BLA Filing Date” has the meaning set forth in Section 6.2 (Joint Commercialization Plans).

1.244

“Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including interest, penalties and additions thereto) imposed by a taxing authority.

1.245

“Term” has the meaning set forth in Section 12.1 (Term).

1.246

[***]

1.247

“Territory” means all countries and territories in the world.

1.248

“Third Party” means a Person other than (a) ITEOS and its Affiliates, and (b) GSK and its Affiliates.

1.249

“Third Party Combination Product” means a Combination Product where one or more Other Components is controlled by a Third Party and licensed to GSK or its Affiliates.

1.250

“Third Party Component Contracts” means those contracts, in existence as of the Effective Date, by and between GSK and a Third Party and listed on Schedule 1.250.

1.251

“Third Party Infringement Claim” has the meaning set forth in Section 11.4.1 (Notice; Control).

1.252

“Third Party IP” has the meaning set forth in Section 9.11 (New Third Party In-Licenses).

1.253

“United States” or “U.S.” means the United States and its territories and possessions.

1.254

“U.S. Net Sales Milestones” has the meaning set forth in Section 8.5.2 (U.S. Net Sales Milestones Following Opt-Out).

1.255

“U.S. Net Sales Milestone Payments” has the meaning set forth in Section 8.5.2 (U.S. Net Sales Milestones Following Opt-Out).

1.256

“Valid Patent Claim” means a claim of (a) any issued, unexpired Patent that shall not have lapsed, been revoked, cancelled or abandoned, been donated to the public, finally disclaimed, nor held finally invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision and which has not been held unenforceable through disclaimer or otherwise, or (b) any patent application within such Patents (including patent applications covering or claiming joint inventions) that has been pending for less than [***] since the first action on the merits in the relevant jurisdiction.

1.257

“VAT” means any value added, sales, use, purchase, turnover or consumption tax as may be applicable in any relevant jurisdiction, including value added tax chargeable under legislation implementing EU Council Directive 2006/112/EC.

2.1

Effectiveness of the Agreement.  This Agreement shall become effective as of the HSR Clearance Date (the “Effective Date”).

2.2

HSR Filing.  Both Parties (or their Affiliates) shall file the appropriate notices (the “HSR Filings”) under the Hart Scott Rodino Antitrust Improvements Act (“HSR Act”) within ten (10) Business Days after the Execution Date.  The Parties shall promptly make required filings to obtain clearance under the HSR Act for the consummation of this Agreement and the transactions contemplated hereby and shall keep each other apprised of the status of any communications with, and any inquiries or requests for additional information from, the United States’ Federal Trade Commission (“FTC”) or the Antitrust Division of the United States Department of Justice (“DOJ”) and shall comply promptly with any reasonable FTC or DOJ inquiry or request of this nature; provided that [***].  Each Party shall be responsible for paying the filing fees it incurs in connection with the HSR Filings.  As used herein, the “HSR Clearance Date” means the earlier of (a) the date on which the FTC or DOJ shall notify the Parties of early termination of the waiting period under the HSR Act or (b) the date on which the applicable waiting period under the HSR Act expires; provided that, if the FTC or DOJ commences any investigation by means of a second request or otherwise, HSR Clearance Date means the date on which any investigation opened by the FTC or DOJ has been terminated, without action to prevent the Parties from implementing the transactions contemplated by this Agreement with respect to the United States.  Notwithstanding any other provisions of this Agreement to the contrary, either Party may terminate its obligation under this Section 2.2 (HSR Filing), and this Agreement shall be void and of no further effect upon notice to the other Party, if the HSR Clearance Date has not occurred on or before the date that is [***] after the date on which both Parties have made their respective HSR Filings and the initial waiting period under the HSR Act has commenced.

3.1

General.

3.1.1

Global Development. The Party to which a particular Development activity is allocated under the Global Development Plan will lead the performance thereof and all Clinical Trials and Development activities for the Licensed Antibody and Licensed Product in the Territory will be conducted by the Parties as set forth in the Global Development Plan.

3.1.2

Development for the Net Sales Territory. As between the Parties, GSK, either itself or as it may determine, by and through its Affiliates, Sublicensees or subcontractors, will be responsible for performing all GSK Sole Development Activities for the Licensed Antibody and Licensed Products set forth in the Global Development Plan, at GSK’s sole cost and expense. Prior to commencing any GSK Sole Development Activities, GSK will include such GSK Sole Development

Activities in the Global Development Plan for each applicable Licensed Product (or an update thereto) and provide such Global Development Plan to the JDC to review, discuss and recommend modifications. ITEOS’s representatives on the JDC may comment thereon, and GSK will consider ITEOS’s comments in good faith, but the JDC will not have an approval right with respect to any GSK Sole Development Activities included in the Global Development Plan. Notwithstanding the foregoing or any other provision to the contrary set forth in this Agreement, if ITEOS reasonably believes that any GSK Sole Development Activity under the Global Development Plan or update thereto may reasonably give rise to a [***]. If the JDC or the Parties’ respective [***] are unable to resolve such matter, then the matter will be resolved in accordance with Section 7.7.2(c) (Resolution of Material Concerns).

3.1.3

ITEOS Phase 1 Clinical Study. ITEOS shall conduct the ITEOS Phase 1 Clinical Study at its sole cost and expense, unless the Parties agree otherwise.

3.2

Global Development.

3.2.1

Global Development Plan. Attached as Schedule 3.2 is the initial Global Development Plan for Licensed Antibodies and Licensed Products (including the corresponding Global Development Budget). Such initial Global Development Plan comprises all Development activities contemplated by the Parties with respect to the Licensed Antibodies and Licensed Products as of the Effective Date and the Parties will discuss, through the JDC, and add additional details (including, with respect to Clinical Trials, study design and protocol, proposed enrollment criteria, the number of patients to be included, the endpoints to be measured, and the statistical design and powering, as needed) to the Global Development Plan (and corresponding Global Development Budget) following the Effective Date in accordance with this Agreement, and each update to the Global Development Plan to add any additional Clinical Trials will include such details. The Clinical Trials set forth in the initial Global Development Plan attached hereto (other than any GSK Sole Development Activities therein) are the Clinical Trials that the Parties are committing to conduct as of the Effective Date (the “Committed Studies”). The Parties also plan to add additional non-clinical Development activities to the Global Development Plan following the Effective Date. The Global Development Plan and Global Development Budget will be updated by the Parties and submitted to the JDC for review and comment not less frequently than annually during the Term, in November of each Calendar Year. In addition, either Party may propose updates to the Global Development Plan and corresponding Global Development Budget from time to time during the Term. Each updated Global Development Budget will be provided to the Financial Working Group prior to being reviewed by the JDC or JSC. The JDC will review, discuss and propose modifications to each update to the Global Development Plan and Global Development Budget and, in turn, submit such updates (as such update may be modified on the recommendation of the JDC) to the Global Development Plan and Global Development Budget to the JSC to review, discuss and determine whether to approve. Each such update to the Global Development Plan and corresponding Global Development Budget will

become effective and will supersede the previous Global Development Plan and corresponding Global Development Budget upon approval thereof by the JSC. Any such updates or amendments to the Global Development Plan and Global Development Budget may be memorialized in the JDC and JSC meeting minutes until the next annual update to the Global Development Plan and Global Development Budget.

3.2.2

Performance under Global Development Plan. Without limiting the JDC’s rights to prepare, review and discuss, or the JSC’s rights to review, discuss and determine whether to approve each Global Development Plan and update thereto (other than the GSK Sole Development Activities), the Party to whom a particular Development activity is allocated under the Global Development Plan will have the right, without seeking JDC review or JSC approval, to make operational decisions with respect to the implementation and performance of such Development activity to the extent consistent with the then-current Global Development Plan and Global Development Budget.

3.2.3

Shared Development Costs. Except as set forth in Section 3.4 (Additional Development), and further subject to Section 6.7 (ITEOS Opt-Out), the Parties will share Development Costs incurred in the performance of Shared Global Development Activities undertaken in accordance with the Global Development Plan and Global Development Budget, with GSK bearing sixty percent (60%) of such Development Costs and ITEOS bearing forty percent (40%) of such Development Costs. Reconciliation and sharing of Development Costs shall be managed in accordance with Section 8.2 (Sharing of Development Costs). The Parties agree to initially spend an aggregate amount of [***] (the “Committed Development Spend”) under the Global Development Budget to undertake the Committed Studies (including as these may be amended or replaced with comparable Clinical Trials of similar scope through an update to the Global Development Plan in accordance with Section 3.2.1 (Global Development Plan)) provided for in the Global Development Plan and any other Clinical Trials that the Parties agree to include in the Global Development Plan that can be conducted within the Committed Development Spend. In addition, if agreed pursuant to an update to the Global Development Plan and Global Development Budget in accordance with Section 3.2.1 (Global Development Plan), then the Parties may also agree to add additional Development activities to the Global Development Plan or spend more than the Committed Development Spend.

3.3

Development Diligence. Each Party will use Commercially Reasonable Efforts to perform the obligations assigned to it under the Global Development Plan. GSK (directly, or through its Affiliates, its or their Sublicensees and subcontractors) will use Commercially Reasonable Efforts to Develop the Licensed Products in the Field in the Territory, including to obtain and maintain Regulatory Approval of Licensed Products in the Field in the United Kingdom, Germany, Italy, France, Spain, China, Japan, and, in the event that ITEOS has delivered an Opt-Out Notice, the United States.

3.4

Additional Development.

3.4.1

Additional Development Proposals. Subject to Section 3.5 (Limits on Development; No Other Development), if either Party proposes to Develop a Licensed Product that the Parties previously agreed to Develop under the Global Development Plan (including a Co-Formulated Product), either as (i) a Licensed Product for a new Indication, or (ii) a Licensed Product as part of a Co-Administration Study (i.e., an existing Co-Administration Therapy in a new Indication or a new Co-Administration Therapy in a new or existing Indication), in each case of (i) or (ii), other than in Indications or in Co-Administration Studies set forth in the then-current Global Development Plan (each, “Proposed Additional Development”), then the proposing Party will present to the JDC to review and discuss, and submit, within [***], to the JSC to review, discuss and determine whether to approve a proposal to add such Proposed Additional Development to the Global Development Plan, including the countries in which such activities would be conducted (which will include at least the U.S. or the European Union) and the allocation of performance of such activities between the Parties (an “Additional Development Proposal”). Each Additional Development Proposal will describe in reasonable detail the applicable non-clinical studies, pre-clinical studies and Clinical Trials, in each case, that the proposing Party desires to conduct as part of such Proposed Additional Development, including a synopsis of the Clinical Trial or other activities, the proposed enrollment criteria, the number of patients to be included, the endpoints to be measured, and the statistical design and powering (the “Additional Development Activities”), as well as a proposed timeline and budget (which budget will include the expected Development FTE Costs, Out-Of-Pocket Costs and Manufacturing Costs to be incurred in the conduct of such Additional Development Activities) and an analysis of the business opportunity and revenue potential for such Additional Development Activities.

3.4.2

JSC Decision Regarding Proposed Additional Development. The JSC will review, discuss and determine whether to approve an Additional Development Proposal within [***] after receipt thereof from the JDC.

(a)

JSC Approval. If the JSC approves an Additional Development Proposal (or a modified version thereof), then upon such an approval the JDC will update the Global Development Plan (and corresponding Global Development Budget) to include such Additional Development Activities set forth in such Additional Development Proposal (as the same may be amended by the JDC or JSC upon such approval).

(b)

No JSC Approval. If the JSC fails to approve an Additional Development Proposal (or a modified version thereof) regarding a Licensed Product in a new Indication or any Co-Administration Studies for any Licensed Product or an appropriate update to the Global Development Budget to account for the performance thereof, then such Proposed Additional Development will not be included in the Global Development Plan or corresponding Global Development Budget and the provisions of Section 3.4.3 (Independent Performance of Additional Development) will apply.

3.4.3

Independent Performance of Additional Development.

(a)

Independent Development Activities. If the JSC fails to approve for inclusion in the Global Development Plan the Proposed Additional Development proposed by either Party (or any modified version thereof), then the proposing Party will have the right, subject to Section 3.5.2 (Material Adverse Development), upon written notice to the other Party, to conduct such Additional Development Activities set forth in the Additional Development Proposal at its own cost and expense. The proposing Party will conduct such Additional Development Activities in accordance with the applicable Additional Development Proposal (including the budget therein) previously provided to the JDC and JSC that the JSC declined to approve. No Development activities included in an Additional Development Proposal may be included in or contemplated by the Global Development Plan if not approved by the JSC. Each applicable Party undertaking any such Additional Development Activities will keep the JDC reasonably informed of any progress and results of activities for such Additional Development Activities undertaken by it or on its behalf, including any and all Data and intellectual property arising from such activities, through its employees on the JDC and the Patent Liaisons, as applicable, at each regularly scheduled meeting thereof.

(b)

Proof of Concept Data. Without limiting any provision of Section 3.4.3(a) (Independent Development Activities), the Party conducting any Additional Development Activities will, following completion of a Proof of Concept Trial included in such Additional Development Activities, share the Data from such Proof of Concept Trial with the JDC. Following receipt of such Data, the JDC may determine to amend the Global Development Plan to include the remainder of the applicable Additional Development Activities and, if the JDC determines to approve such an amendment to the Global Development Plan, then the other Party will reimburse the proposing Party for (i) if the proposing Party is ITEOS, sixty percent (60%), and (ii) if the proposing Party is GSK, forty percent (40%), in each case ((i) and (ii)), of the Out-of-Pocket Costs, Development FTE Costs and Manufacturing Costs incurred by the proposing Party in the performance of such Additional Development Activities solely through completion of the Proof of Concept Trial for the U.S. and the European Union in accordance with the applicable Additional Development Proposal and the budget presented to the JDC in

the Additional Development Proposal plus an amount equal to one-hundred percent (100%) of the applicable amount set forth in the foregoing clause (i) or (ii), as applicable, in consideration for the proposing Party taking the development risk for the new Indication or new Co-Administration Studies (for example, if GSK spent $100,000 on such Additional Development Activities, and ITEOS was obligated to reimburse GSK for such Additional Development Activities pursuant to this Section 3.4.3(b) (Proof of Concept Data), then ITEOS would owe GSK $40,000 in reimbursement plus $40,000 in consideration of the development risk, for a total of $80,000). If the JDC does not determine to add such Additional Development Activities to the Global Development Plan, then the proposing Party may continue to conduct such Additional Development Activities in accordance with the provisions of this Section 3.4 (Additional Development).

(c)

Receipt of Regulatory Approval. Subject to Section 6.7.3 (Effects of Opt-Out), upon receipt of Regulatory Approval in the U.S. (if any) for the Licensed Product in the new Indication or as part of a new Co-Administration Therapy, in each case, that was the subject of Additional Development Activities, the other Party will reimburse the proposing Party for (i) if the proposing Party is ITEOS, sixty percent (60%), and (ii) if the proposing Party is GSK, forty percent (40%), in each case ((i) and (ii)), of the Out-of-Pocket Costs, Development FTE Costs and Manufacturing Costs incurred by the proposing Party in the performance of such Additional Development Activities for the U.S. and the European Union in accordance with the applicable Additional Development Proposal and the budget presented to the JDC in the Additional Development Proposal as set forth in Section 3.4.1 (Additional Development Proposals) (provided that the costs incurred by the proposing Party that are subject to reimbursement under this Section 3.4.3(c) (Receipt of Regulatory Approval) shall be capped at [***] of such budget) plus an amount equal to [***] of the applicable amount set forth in the foregoing clause (i) or (ii), as applicable, in consideration for the proposing Party taking the development risk for the new Indication or new Co-Administration Studies (for example, if GSK spent $100,000 on Additional Development Activities, and ITEOS was obligated to reimburse GSK for such Additional Development Activities pursuant to this 3.4.3(c) (Receipt of Regulatory Approval), then ITEOS would owe GSK $40,000 in reimbursement plus $40,000 in consideration of the development risk, for a total of $80,000). Following the date of Regulatory Approval for any new Indication or any Licensed Product as part of a new Co-Administration Therapy, the JDC will update the Global Development Plan and Global Development Budget to include any further or remaining Development of such approved new Indication, or Licensed Product as part of a new Co-Administration Therapy (as applicable) for the U.S. or European Union, and the JSC will approve such updates.

(d)

Supporting Documentation. Upon (i) the JDC’s determination to add Additional Development Activities to the Global Development Plan pursuant to Section 3.4.3(b) (Proof of Concept Data) or (ii) receipt of any Regulatory Approval in the U.S. for the Licensed Product in the new Indication or as part of a new Co-Administration Therapy, in each case, that was the subject of such Additional Development Activities, in each case, ((i) and (ii)), the proposing Party shall promptly submit all information and documentation supporting such Out-of-Pocket Costs, Development FTE Costs and Manufacturing Costs to the Financial Working Group in order for the sharing of such Out-of-Pocket Costs, Development FTE Costs and Manufacturing Costs to be managed in accordance with Section 8.2.3 (Reimbursement for Additional Development) after the Financial Working Group receives such information and documentation.

(e)

No Regulatory Approval. If such Regulatory Approval is not obtained, then the other Party will not be obligated to reimburse the proposing Party for the Out-of-Pocket Costs, Development FTE Costs or Manufacturing Costs incurred by the proposing Party in the performance of such Additional Development Activities.

3.5

Limits on Development; No Other Development.

3.5.1

No Fixed-Dose Co-Formulation Products or Other Formulations. Neither Party may conduct Development activities (including as Additional Development Activities hereunder) with respect to (a) any Co-Formulated Products that are not already agreed to be Developed by the Parties under the Global Development Plan or (b) a Licensed Product in a formulation that is not already agreed to be Developed by the Parties under the Global Development Plan. If either Party proposes to Develop any other Co-Formulated Products or a Licensed Product in any other formulation, then, in each case, such Party will propose an applicable update to the Global Development Plan (and corresponding Global Development Budget) to the JDC for the JDC to review and discuss, and submit to the JSC to review, discuss, and determine whether to approve pursuant to Section 3.2.1 (Global Development Plan). If the JSC approves inclusion of such Co-Formulated Product or such other formulation, as applicable, in the Global Development Plan, then the Parties will Develop such Co-Formulated Product or Licensed Products in such formulation, as applicable, in accordance with the Global Development Plan.

3.5.2

Material Adverse Development. Neither Party may conduct Additional Development Activities, that, if conducted, either Party reasonably believes may give rise to a Material Safety or Commercialization Concern. Notwithstanding the foregoing or any other provision to the contrary set forth in this Agreement, if either Party reasonably believes that any Development activity set forth in an Additional Development Proposal or any Additional Development Activities undertaken by the proposing Party subject to Section 3.4.3(a) (Independent Development Activities) may present a Material Safety or Commercialization Concern, then (a) such Party may raise such concern to the JDC in order for the [***], and (b) [***].

ITEOS’s [***], as applicable, will promptly meet to discuss such matters.  If the JDC or the Parties’ respective [***] are unable to resolve such matters, then the issue will be resolved in accordance with Section 7.7.2(c) (Resolution of Material Concerns).

3.5.3

Third Party Combinations.

(a)

Limitation on Third Party Combinations.  Except as permitted under this Section 3.5.3 (Limitation On Third Party Combinations), neither Party may conduct Additional Development Activities with respect to a Licensed Product in a Co-Administration Study with a compound, antibody, or product that is owned by a Third Party that modulates the same target as a compound, antibody, or product Controlled by the other Party as of the date such Party wishes to initiate such Additional Development Activities. If either Party proposes to conduct Additional Development Activities with respect to a Licensed Product in a Co-Administration Study with a compound, antibody, or product that modulates the same target as a compound, antibody, or product Controlled by the other Party as of the date such Party wishes to initiate such Additional Development Activities, then such proposing Party will notify the other Party and the JDC in writing  of such desire. The JDC shall meet promptly thereafter to discuss the Proposed Additional Development, including all the details to be provided in the Additional Development Proposal as set forth in Section 3.4.1 (Additional Development Proposals). The other Party shall have [***] following such written notice to notify the proposing Party in writing whether it is interested in providing the compound, antibody or product Controlled by it to the proposing Party for such Proposed Additional Development (the “Notice Period”), and the Parties will negotiate in good faith regarding the terms and conditions under which the proposing Party might obtain such rights to Develop such compound, antibody, or product in a Co-Administration Study with a Licensed Product, and the supply of such compound, antibody, or product by the other Party, for a period of [***] commencing upon the other Party’s delivery of written notice to the proposing Party indicating their interest in negotiating such terms (the “Negotiation Period”). If (i) the other Party does not deliver notice to the proposing Party during the Notice Period indicating its interest in negotiating with the proposing Party, (ii) the Parties are unable to reach agreement on terms granting the proposing Party the right to do such Proposed Additional Development and providing for the supply of such compounds, antibodies or products during the Negotiation Period, or (iii) the Parties otherwise agree that the proposing Party should seek rights to the applicable compound, antibody, or product from a Third Party, then in each case ((i) through (iii)), the proposing Party will be permitted to enter into an agreement with a Third Party regarding obtaining rights to Develop the applicable compound, antibody, or product in a Co-Administration Study with a Licensed Product and obtaining supplies of such compound, antibody, or product as long as doing so will not put either Party in breach of any obligations to any Third Parties (including exclusivity obligations

related to the compound, antibody or product Controlled by the other Party) under any agreement with any such Third Parties that are applicable to the other Party’s Additional Development Activities (which the proposing Party shall have been made aware of by the other Party together with disclosure of a copy of the relevant agreement(s) with the Third Parties, redacted as reasonably necessary to comply with obligations to such Third Party, provided that such redacted copy must include (in unredacted form) those provisions that are relevant to determining what provisions are applicable to the other Party’s Additional Development Activities).  Notwithstanding any provision to the contrary set forth in this Agreement, the Development of the applicable Third Party compound, antibody, or product in a Co-Administration Study with a Licensed Product will be considered Additional Development Activities under this Agreement and will be treated as such in accordance with Section 3.4 (Additional Development).

(b)

Third Party Combination Exception. [***].

3.5.4

No Other Development. Except for Additional Development Activities conducted pursuant to Section 3.4 (Additional Development), neither Party will perform Development activities for any Licensed Antibodies or Licensed Products that are not set forth in the Global Development Plan, other than immaterial activities undertaken by or on behalf of a Party directly in support of the activities contemplated by the Global Development Plan or in respect of Additional Development Activities.

3.6

Development Reporting. [***], with respect to any Development activities conducted by or on behalf of either Party with respect to the Licensed Antibodies or Licensed Products under this Agreement, within [***] following the end of [***], each Party shall prepare and provide to the other Party and the JDC (or the JSC, if the JDC is no longer meeting) a detailed written report that summarizes: (a) the Development activities (including CMC Development and other Manufacturing-related Development activities) performed and the status of activities and progress with respect to the activities set forth in the Global Development Plan (including enrollment data), and shall identify any issues or circumstances of which it is aware that may prevent or adversely affect in a material manner its future performance of activities assigned to it under the then-current Global Development Plan, and (b) all material Data generated since the last [***] report (each, a “Development Report”). Solely in the event that, and for so long as, the effects of forced opt-out set forth in Section 6.7.4 (Effects of Forced Opt-Out) apply, the Development Reports provided by GSK to the JSC pursuant to this Section 3.6 (Development Reporting) will include GSK’s [***] ITEOS’s JSC representatives may review, but will have no right to comment on or approve. Each Party and the JDC (or the JSC, if the JDC is no longer meeting) shall have the right to review all reports and Data related to any Clinical Trials for a Licensed Product, whether such reports are generated by or on behalf of GSK, ITEOS, a Sublicensee or a subcontractor. Each Party will respond to the reasonable questions or requests of the other Party’s JDC representatives (or JSC representatives, if the JDC is no longer meeting), as applicable, for additional information relating to such Party’s Development activities under this Agreement in a timely manner.

3.7

Performance of Development Activities; Development Records. Each Party will perform, and ensure that their Affiliates, Sublicensees, and subcontractors perform, its Development activities as contemplated under this Agreement in a good scientific manner and in compliance with its Internal Policies, Applicable Law, including (if applicable) laws regarding the environment, safety and industrial hygiene, and GMP, GLP, GCP, informed consent and Institutional Review Board regulations, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects. Each Party and its Affiliates will maintain written or electronic records, in sufficient detail, in a good scientific manner (in accordance with GLP, GCP, and GMP, as applicable), and appropriate for regulatory and patent purposes, and that (a) are complete and accurate in all material respects and properly reflect all Development work performed and results achieved, in each case, by or on behalf of such Party and its Affiliates under this Agreement and (b) record only such activities and not include or be commingled with records of activities outside the scope of this Agreement, which records will be retained for at least [***] years following expiration or termination of this Agreement, or for such longer period as may be required by Applicable Law or a Party’s Internal Policies. The JDC shall have the right, during normal business hours and upon [***] Business Days’ notice, to inspect and copy any records kept by a Party in accordance with this Section 3.7 (Performance of Development Activities; Development Records). Each Party will provide the other with copies of relevant Internal Policies promptly following the Effective Date or from time-to-time as additional Internal Policies become relevant, and will provide updates of such Internal Policies as appropriate.  

3.8

Obligations to Third Parties Regarding Combination Products.

3.8.1

Existing [***]. The Parties each acknowledge where a Licensed Product being Developed under this Agreement is a [***].

3.8.2

[***] Contracts With Third Parties. If, at any time during the Term, (a) the Parties agree (through the JDC) to Develop a Licensed Product in a Co-Administration Study or as a Combination Product (including a Co-Formulated Product) with a compound, antibody or product that is owned or controlled by a Third Party under the Global Development Plan or (b) either Party proposes to Develop a Licensed Product in a Co-Administration Study with a compound, antibody or product that is owned or controlled by a Third Party in an Additional Development Proposal and the JSC does not approve the inclusion of such Additional Development Activities in the Global Development Plan under Section 3.4.2(a) (JSC Approval), and, in either case ((a) or (b)), either Party is party to an agreement related to such compound, antibody or product with such Third Party at such time, then such Party will [***]. If, at any time during the Term, the Parties agree (through the JDC) to Develop a Licensed Product in a Co-Administration Study or as a Combination Product (including a Co-Formulated Product), including pursuant to 3.4.3(b) (Proof of Concept Data) or 3.4.3(c) (Receipt of Regulatory Approval) with a compound, antibody or product that is owned or controlled by a Third Party under the Global Development Plan and neither Party is party to an agreement with such Third Party related to such compound, antibody or product with such Third Party at such time, then any [***].

3.9

Pharmacovigilance and Adverse Event Reporting.  The Parties will cooperate with regard to the reporting and handling of safety information involving the Licensed Products in accordance with the Applicable Law, regulatory requirements, and regulations on pharmacovigilance and clinical safety. For each Licensed Product, GSK will be responsible for all processing of information related to any adverse events for such Licensed Product. Each Party will provide to the other Party the relevant safety information it receives (either directly or indirectly) related to a Licensed Product in a timely manner. The drug safety departments from each of the Parties shall meet and agree upon a written pharmacovigilance agreement for exchanging adverse event and other safety information and timelines within [***] days of the Effective Date, which pharmacovigilance agreement will provide for the transfer of ITEOS’s then-current safety database for Licensed Products to GSK, including the timing for such transfer. Such written pharmacovigilance agreement shall ensure that adverse event and other safety information is exchanged according to a schedule that will permit each Party (and its Sublicensees or designees) to comply with all Applicable Laws. GSK will own and maintain the global safety database for all Licensed Products.

3.10

Data Integrity Practices.

3.10.1

Requirements. All activities conducted under the Global Development Plan, including the conduct of any clinical studies, will be conducted in accordance with the following practices:

(a)

Data will be generated using sound scientific techniques and processes;

(b)

Data will be accurately recorded by the Persons performing the applicable Development activities in accordance with data integrity practices;

(c)

Data will be analyzed appropriately without bias in accordance with data integrity practices;

(d)

Data and results from experiments and clinical studies will be stored securely such that it can be easily retrieved; and

(e)

Data trails will exist to easily demonstrate or reconstruct key decisions made during the performance of all activities under the Global Development Plan, presentations made about such activities, and conclusions reached with respect to the activities undertaken in the performance of the Global Development Plan.

3.10.2

Changes to Data Integrity Requirements. At any time after the Effective Date and for so long as ITEOS is conducting Development of Licensed Products under the Global Development Plan, GSK may request changes to the requirements set forth above in this Section 3.10 (Data Integrity Practices) where GSK reasonably believes such changes are required to ensure that such activities are undertaken in compliance with GSK’s Internal Policies or Applicable Law, and ITEOS shall use reasonable efforts to give effect to such changes as soon as reasonably practicable following receipt of GSK’s written request, which request will include a copy of

any updated GSK Internal Policies. GSK shall be permitted, in its sole discretion, to undertake on-site compliance audits of ITEOS’s data integrity practices in respect of the activities performed by ITEOS to inspect ITEOS’s compliance with the terms of this Section 3.10 (Data Integrity Practices) by providing ITEOS with [***] days’ written notice of GSK’s intent to do so, such audits to be conducted at a time agreed by the Parties and no more frequently than once every [***] during the Term.

3.11

Animal Welfare.

3.11.1

With respect to any activities conducted by or on behalf of either Party under the Global Development Plan or in connection with any Additional Development Activities that involve the use of animals, including any animal studies, such Party agrees to comply with this Section 3.11.1 (Animal Welfare). The Parties shall comply with all Applicable Laws related to the care, welfare and ethical treatment of animals in the country where it is performing Development activities under this Agreement.  The Parties further agree to comply with the “3Rs” principles – reducing the number of animals used, replacing animals with non-animal methods whenever possible and refining the research techniques used.  All work must be conducted in adherence to the core principles for animals set forth below in this Section 3.11 (Animal Welfare).  Local customs, norms, practices or Applicable Laws may be additive to the core principles, but the Parties agree to comply and shall procure and ensure each Party’s subcontractors comply, at a minimum, with these core principles:

(a)

Access to species appropriate food and water;

(b)

Access to species specific housing, including species appropriate temperature and humidity levels;

(c)

Provision of humane care and a program of veterinary care through guidance of a veterinarian;

(d)

Animal housing that minimizes the development of abnormal behaviors;

(e)

Adherence to principles of replacement, refinement and reduction in the design of in vivo or ex vivo studies with processes to optimize animal use and to ensure effective population management;

(f)

Work is supported by a relevant scientific justification or rationale, approved by an institutional ethical review process and subjected to independent scientific review;

(g)

Commitment to minimizing pain and distress during in vivo and ex vivo studies; and

(h)

Work is performed by staff documented as trained and competent to conduct the procedures for which they are responsible.

3.11.2

All animal study protocols shall undergo an ethical review, whether or not required by Applicable Law, and written documentation confirming ethical review shall be maintained by the applicable Party until three (3) years after the expiration or termination of this Agreement demonstrating that the review was completed. Each Party shall have the right to inspect the other Party’s records upon reasonable notice; provided that such inspection shall not extend to those parts of the records that the other Party can demonstrate to be subject to confidentiality arrangements with Third Parties. Each Party shall use reasonable efforts to ensure that its subcontractors will materially comply with the obligations identified in this Section 3.11.2 (Animal Welfare).

3.11.3

If a Party is currently accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International, then such Party agrees to use reasonable efforts to maintain such accreditation during the Term.

3.11.4

Each Party shall have policies or procedures in place to ensure the qualification and training of its employees that work with animals.  Each Party shall use reasonable efforts to ensure that its subcontractors will comply with the obligations identified in this Section 3.11.4 (Animal Welfare).

3.11.5

Upon reasonable advanced written notice and subject to the agreements each Party has with its subcontractors, each Party (or its subcontractor/delegate) shall have the right to inspect the other Party’s records and facilities as they relate to the conduct of animal work under the Global Development Plan or in connection with any Additional Development Activities.  The scope of such inspection may include a tour of the facility, the opportunity to view relevant SOPs, training records, building management records, animal health records, ethical review documents, and any other documents in the applicable Party’s or its Affiliates’ or subcontractors’ possession reasonably necessary to assess compliance by such other Party with any of the terms and conditions of this Section 3.11.5 (Animal Welfare); provided that such inspection shall not extend to those parts of the records and facilities that the other Party can demonstrate to be subject to confidentiality arrangements with Third Parties.  To the extent that any significant deficiencies are identified as the result of such inspection, the other Party shall endeavor in good faith to take reasonable and practical corrective measures to remedy any such material deficiencies.

3.11.6

Each Party shall promptly provide to the other Party information regarding any material deficiencies impacting the activities under the Global Development Plan or in connection with any Additional Development Activities regarding its animal care and welfare program and any corrective actions taken. Where relevant to the Global Development Plan or in connection with any Additional Development Activities, each Party shall also provide the other Party copies of any regulatory enforcement action or inspection findings issued to the providing Party (or subcontractor) and relating to a systemic failure in the ethical care and treatment of animals, regardless of whether such enforcement action or inspection finding relates specifically to the conduct of the Global Development Plan or in connection

with any Additional Development Activities. The JDC shall discuss and develop a remediation strategy for any such material deficiencies regarding animal care and welfare. Each Party shall use reasonable efforts to ensure that its subcontractors will comply with the obligations identified in this Section 3.11.6 (Animal Welfare).

3.11.7

Each Party shall have a procedure in place to assess and approve its external suppliers and distributors who supply animals to such Party to (a) ascertain and confirm the quality of the animals supplied, (b) ensure legal requirements for the care and welfare of animals are met, (c) ensure that only purpose bred animals are used to conduct animal work under the Global Development Plan or in connection with any Additional Development Activities, (d) minimize the distance of suppliers from such Party’s test facility (where practicable), (e) ensure minimum stress in transport processes (e.g., stocking densities, carrying crates, food and water), and (f)  ensure checks are in place on arrival to confirm only healthy animals are used in the conduct of the Global Development Plan or in connection with any Additional Development Activities. Such Party shall document the approval process for its animal suppliers and distributors, which documentation shall be made available to the other Party upon reasonable request.

3.12

Material Transfers.

3.12.1

During the course of the performance of the Global Development Plan, either Party (or such Party’s designee) (the “Materials Transferring Party”) may transfer to the other Party or its designee (the “Materials Receiving Party”) certain Materials for use in connection with activities contemplated under the Global Development Plan.  Such Materials will be provided under the terms and conditions of this Agreement and in such amount as described in the material transfer record for the particular transfer (“MTR”), in the form attached hereto as Schedule 3.12, which MTR shall set forth the type and name of the Materials transferred, the amount of the Materials transferred, the date of the transfer of such Materials and the proposed use of such Materials by the Materials Receiving Party. For clarity, this Section 3.12 (Material Transfers) shall not apply to the clinical supply of Licensed Antibodies or Licensed Product, which shall be supplied under a clinical supply agreement or otherwise in accordance with Article 5 (Manufacturing and Supply).

3.12.2

MATERIALS SUPPLIED BY THE MATERIALS TRANSFERRING PARTY HEREUNDER ARE SUPPLIED IN “AS IS” CONDITION WITH NO WARRANTY, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WARRANTIES OF MERCHANTABILITY, TITLE, NON-INFRINGEMENT, EXCLUSIVITY, OR FITNESS FOR A PARTICULAR PURPOSE.  ANY MATERIAL DELIVERED PURSUANT TO THIS AGREEMENT IS UNDERSTOOD TO BE EXPERIMENTAL IN NATURE AND MAY HAVE HAZARDOUS PROPERTIES.  THE MATERIALS RECEIVING PARTY WILL HANDLE THE MATERIAL ACCORDINGLY AND WILL INFORM THE MATERIALS TRANSFERRING PARTY IN WRITING OF ANY ADVERSE EFFECTS EXPERIENCED BY PERSONS HANDLING THE MATERIAL.

3.12.3

The Materials Receiving Party acknowledges that, except for the licenses and other express rights granted herein, it does not have any claim to the Materials supplied by the Materials Transferring Party, or any license or rights to any proprietary information or intellectual property rights in or to the Materials.  For clarity, the Materials shall remain the sole and exclusive property of the Materials Transferring Party and shall be returned or destroyed at the request of the Materials Transferring Party.

3.12.4

The Materials Receiving Party agrees that the Material(s):

(a)

will be used solely for, and in compliance with, the activities described in the Global Development Plan;

(b)

will be used in compliance with all Applicable Laws;

(c)

will not be used in human subjects, in Clinical Trials, or for diagnostic purposes involving human subjects (except, in each case, as otherwise described in this Agreement);

(d)

will be used only by the Materials Receiving Party and only in the Materials Receiving Party’s laboratory, except with the prior written consent of the Materials Transferring Party;

(e)

will not be transferred to a Third Party without the prior written consent of the Materials Transferring Party; and

(f)

the Materials Receiving Party shall not reverse engineer or attempt to determine the chemical structure, make-up or sequence of, or determine the chemical or biological properties of, or make or attempt to make any analogues, progeny or derivatives of, or modifications to, such Materials except as expressly required to carry-out such Party’s obligations hereunder, including its activities pursuant to the Global Development Plan.

3.12.5

The Materials Receiving Party assumes all liability for damages that may arise from its use, storage or disposal of the Materials.  The Materials Transferring Party shall not be liable to the Materials Receiving Party for any loss, claim or demand made by the Materials Receiving Party, or made against the Materials Receiving Party by any Third Party, due to or arising from the use of the Materials, except to the extent permitted by Applicable Law when caused by the negligence, willful misconduct, fraud or fraudulent misrepresentation of the Materials Transferring Party.  Upon termination of the relevant Development requiring use of the Materials or the Agreement in its entirety, as applicable, except for any continuing rights as set forth in this Agreement, the Materials Receiving Party shall discontinue its use of any Materials and shall, upon direction of the Materials Transferring Party, return or destroy (and certify destruction of) any remaining Material in compliance with all Applicable Laws.

3.13

R&D Ethics & Compliance. Each Party’s compliance officer responsible for Development activities (or other equivalent personnel of either Party) (each, an “R&D Compliance Officer”) will meet within [***] after the Effective Date to (a) review each Party’s Internal Policies relevant to Development activities to be undertaken in accordance with this Agreement, (b) discuss implications for the Development Program, and (c) propose to the JDC within [***] of the Effective Date (unless otherwise agreed by the Parties in writing) a plan regarding how each Party’s R&D Compliance Officer or other appropriate personnel will support the JDC in addressing any ethics or compliance issues and risks for the Development Program.  The JDC shall review such plan in good faith and agree to any modifications, with the final agreed plan documented in the JDC minutes.

4.1

General.

4.1.1

Shared Global Development Activities. The Parties will conduct regulatory activities with respect to the Licensed Products in accordance with the regulatory strategy set forth in the Global Development Plan and the terms of this Article 4 (Regulatory Matters) related to the Shared Global Development Activities. The JDC will oversee the implementation of, and discuss progress regarding, such regulatory strategy.

4.1.2

GSK Sole Development Activities. GSK will conduct regulatory activities with respect to the Licensed Products in accordance with the regulatory strategy set forth in the Global Development Plan and the terms of this Article 4 (Regulatory Matters) related to the GSK Sole Development Activities. The JDC will oversee implementation of, and discuss progress regarding such regulatory strategy.

4.1.3

Regulatory Responsibilities. Subject to the remainder of this Article 4 (Regulatory Matters), each Party will lead all regulatory matters relating to Licensed Products in the countries in which it is responsible for conducting Development, for so long as such Party is responsible for such Development in accordance with the Global Development Plan or as required to conduct Additional Development Activities being conducted by such Party in accordance with Section 3.4 (Additional Development) (such Party, the “Regulatory Responsible Party”). Subject to each Party’s right of reference as described in Section 4.5 (Right of Reference), the Regulatory Responsible Party shall file for in its name, and will own, all Regulatory Filings in the countries in which it is responsible for Development and will own all Regulatory Approvals for all Licensed Products in the Territory until such Regulatory Filings are assigned to GSK pursuant to Section 4.2 (Assignment of Regulatory Filings).  Subject to this Article 4 (Regulatory Matters), the Regulatory Responsible Party will have the sole responsibility for (a) overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, each applicable Regulatory Authority with respect to each Licensed Product; (b) interfacing, corresponding and meeting with each Regulatory Authority in the Territory with respect to each Licensed Product; and (c) seeking

and maintaining all Regulatory Approvals in the Territory with respect to each Licensed Product, in each case, for so long as such Party is the Regulatory Responsible Party with respect to such Licensed Product. In addition, notwithstanding any provision to the contrary set forth in this Agreement, the Regulatory Responsible Party will (i) not be required to delay any actions, communications, or filings with, or submissions to any applicable Regulatory Authorities in a manner that affects the Regulatory Responsible Party’s ability to comply with any Regulatory Authority requirement or deadline or Applicable Law in the applicable jurisdiction or that would delay receipt of Regulatory Approval for a Licensed Product anywhere in the Territory and (ii) have final say on the content of all Regulatory Filings with Regulatory Authorities in the Territory for so long as such Party is the Regulatory Responsible Party with respect to such Licensed Product.

4.1.4

Regulatory Cooperation. As reasonably requested by the Regulatory Responsible Party from time to time during the Term, the other Party shall promptly provide reasonable assistance to the Regulatory Responsible Party with respect to filings and other interactions with Regulatory Authorities regarding Licensed Antibodies and Licensed Products.

4.2

Assignment of Regulatory Filings. Unless otherwise agreed by the Parties, no later than [***], if ITEOS holds, in its name, any Regulatory Filings (including INDs) with respect to any Licensed Products as of such date, unless otherwise agreed by the Parties, ITEOS will assign to GSK all rights, title, and interests in and to each such Regulatory Filing (including INDs) filed in the Territory, and will transfer to GSK copies (in electronic or other format) of those Regulatory Filings owned by ITEOS or its Affiliates that are necessary to assign such INDs to GSK, provided, however, that ITEOS will not assign Regulatory Filings (including INDs) to GSK regarding Additional Development Activities being conducted by ITEOS in accordance with Section 3.4 (Additional Development) until (a) such Additional Development Activities are added to the Global Development Plan pursuant to Section 3.4.3(b) (Proof of Concept Data) or (b) the applicable Regulatory Approval is obtained in connection with such Additional Development Activities, as described in Section 3.4.3(c) (Receipt of Regulatory Approval), in each case, which assignment of Regulatory Filings shall be in a manner and on the timelines to be agreed by the Parties.

4.3

Meetings and Communications.  During the Term, each Party will keep the other Party reasonably informed of any material communications from, or meetings with, any Regulatory Authority pertaining to such Party’s Development activities (including Additional Development Activities) performed under this Agreement promptly following receipt thereof. To the extent relating to a Licensed Product, the Regulatory Responsible Party with respect to such Licensed Product, will provide the other Party with: (a) to the extent allowable by Applicable Laws and the relevant Regulatory Authority and to the extent practicable, an opportunity to have one or more of its representatives attend and observe substantive discussions and meetings with the FDA or any other Regulatory Authority with respect to any Clinical Trials or other matters (e.g., CMC or non-clinical issues); (b) a copy of any material documents, reports or correspondence submitted to the

FDA or any other Regulatory Authority (which copies may be redacted as necessary to comply with any confidentiality or information protection requirements under any applicable Third Party Component Contracts); and (c) reasonable advanced notice (to the extent practicable) of substantive meetings, scheduled or unscheduled, with the FDA or any other Regulatory Authority. All such documents or reports described in subclause (b) above will be provided to the non-Regulatory Responsible Party at least [***] prior to their submission to the applicable Regulatory Authority (or such later date as the Parties may reasonably agree), and the Regulatory Responsible Party will reasonably consider any comments provided by the non-Regulatory Responsible Party with respect to such documents or reports in good faith. To the extent a Party receives material written or oral communications from the FDA or any other Regulatory Authority relating to a Licensed Product or activities under this Agreement with respect to a Licensed Product, such Party shall notify the other Party and provide a copy of any such written communications to the other Party within [***]. In addition, upon a reasonable request from the other Party, each Party shall provide copies of other documents, reports or communications from or to Regulatory Authorities relating to Licensed Products.

4.4

Exchange of Development Data. Without limiting the other provisions of this Agreement, at the request of a Party or  upon direction by the JSC or JDC, the other Party shall provide to the requesting Party all pertinent Data developed by or on behalf of such Party, as applicable, in connection with the Development of a Licensed Product under this Agreement or the performance of other activities under the Global Development Plan or Commercialization Plans hereunder subject to any applicable confidentiality arrangements with Third Parties [***]. The format of, and media for exchanging, such Data shall be decided by the JDC.

4.5

Right of Reference. Each Party shall have the right, without obtaining the approval of the other Party and without additional payment to such other Party (other than payments expressly provided in this Agreement), to reference (including a “Right of Reference” as that term is defined in 21 C.F.R. § 314.3(b) (or any successor rule), and corresponding rights under the foreign equivalents of 21 C.F.R. § 314.3(b) in the applicable countries in the Territory), copy, access and use Data, and all reports, documents, Regulatory Filings, and other information developed by any Party that is derived from or includes such Data, in each case, that is related to a Licensed Antibody or Licensed Product and that is owned or Controlled by a Party or its Affiliates (a) for purposes of preparing and submitting INDs, NDAs, BLAs and other Regulatory Filings for the Licensed Products, and (b) preparing and filing patent applications, in each case ((a) and (b)) in accordance with this Agreement, and, with respect to such Data, reports, documents and other information developed by the other Party, solely to the extent permitted under this Agreement.

4.6

Recall, Withdrawal or Field Alert of a Licensed Product.

4.6.1

Notification and Determination. If any Governmental Authority threatens in writing or initiates any action to remove a Licensed Product from the market (in whole or in part) in the Territory, then the Party receiving notice thereof will notify the other Party of such communication immediately, but in no event later than [***] after receipt thereof. Notwithstanding the foregoing, in all cases GSK will

determine whether to initiate any recall, withdrawal or field alert of such Licensed Product in the applicable territory, including the scope of such recall or withdrawal (e.g., a full or partial recall, or a temporary or permanent recall) or field alert. Before GSK initiates a recall, withdrawal, or field alert for a Licensed Product in the Territory the Parties will promptly meet and discuss in good faith the reasons therefor, provided that such discussions will not delay any action that GSK reasonably believes should be taken in relation to any actual or potential recall, withdrawal or field alert. In the event of any such recall, withdrawal, or field alert, GSK will determine the necessary actions to be taken and will implement such action.  Without limiting the foregoing, either Party will have the right to propose that a recall, withdrawal or field alert for a Licensed Product should be initiated by such Party, but GSK will have the right to make the final decision as to whether or not to initiate the recall, withdrawal or field alert. Notwithstanding the foregoing, if ITEOS notifies GSK of a Manufacturing issue related to a Licensed Product that ITEOS had Manufactured during the October 2021 Campaign and that ITEOS reasonably believes could give rise to a recall, withdrawal or field alert, then GSK will initiate such recall, withdrawal, or field alert in accordance with ITEOS’s request.

4.6.2

Recall Cost Allocation.  All costs and expenses associated with implementing a recall, withdrawal, or field alert with respect to a Licensed Product will be allocated between ITEOS and GSK as follows: (a) subject to clause (b)(ii) below, such costs and expenses included in Recall Expenses will be shared equally (50:50) by the Parties as Allowable Expenses, in accordance with Section 8.3 (Pre-Tax Profit or Loss Sharing) in the event of such a recall, withdrawal, or field alert with respect to a Licensed Product in the Profit-Sharing Territory, (b) GSK will be responsible for such costs and expenses (i) in the event of such a recall of a Licensed Product in the Net Sales Territory and (ii) that are associated with any recall, withdrawal, or field alert of a Licensed Product that is due to the negligence or willful misconduct of GSK, its Affiliates, Sublicensees or its Third Party contractors, including due to Manufacturing (including labeling) of such Licensed Product, and (c) ITEOS will be responsible for such costs and expenses that are associated with any recall, withdrawal or field alert of a Licensed Product that is due to the negligence or willful misconduct of ITEOS, its Affiliates, Sublicensees or its Third Party contractors in the Net Sales Territory.

5.1

Manufacturing.

5.1.1

JDC Oversight; Efforts.  The JDC, in consultation with the Financial Working Group, shall oversee CMC Development, supply chain strategy, establishment of Manufacturing sources, capacity, supply chains, and Manufacture of Licensed Antibodies and Licensed Products, subject to the provisions of this Article 5 (Manufacturing and Supply).  Each Party shall use reasonable efforts to execute and to perform, or cause to be performed through its Affiliates, the Existing CMO,

or GSK CMO, the Manufacturing activities assigned to it under this Agreement and by the JDC, and to cooperate with the other Party in carrying out such Manufacturing activities.  If the JDC is unable to resolve any dispute regarding the activities described in this Section 5.1.1 (JDC Oversight; Efforts), then the issue will be resolved in accordance with Section 7.7 (Decision-Making).

5.1.2

Clinical Supply. Subject to the terms of [***] (“Existing CMO Agreement”), ITEOS shall be solely responsible, through its Existing CMO, for Clinical Manufacture and supply of Licensed Antibodies and Licensed Products required for the performance of activities under the Global Development Plan from the Effective Date until completion [***] (the “October 2021 Campaign”), after which GSK shall be solely responsible for Clinical Manufacture and supply of Licensed Antibodies and Licensed Products throughout the Territory (including for the performance of activities under the Global Development Plan).

5.1.3

Commercial Supply. Subject to Section 5.1.5 (Second Source), GSK shall be solely responsible for all Commercial Manufacture and supply of Licensed Products throughout the Territory.

5.1.4

Request to Supply. If ITEOS requests supply of Licensed Product from GSK for Development activities (including Additional Development Activities) conducted hereunder, then prior to any such supply, the Parties will enter into a clinical supply agreement and quality agreement under which GSK will, subject to Section 5.3 (Prioritization of Supply), supply Licensed Product to ITEOS at a supply price equal to [***]. Any requests for supply of Licensed Product by ITEOS from GSK will be ordered under such clinical supply agreement pursuant to the terms thereof and the Parties will not be obligated to enter into any additional supply agreements. The clinical supply agreement shall include terms for the required lead time from the date GSK receives the purchase order from ITEOS and the requested delivery date in the purchase order and will be on terms customary for supply agreements between collaboration partners with respect to Development of products.

5.1.5

Second Source. The Parties agree that GSK will maintain a supply relationship with ITEOS’s Existing CMO with respect to the supply of Licensed Products during the Term, provided, however, that [***] (“GSK CMO Agreement”). [***].

5.1.6

Supply Price Updates. For purposes of determining GSK’s Manufacturing Costs with respect to Licensed Products, the Standard Cost of Goods Manufactured will be updated annually as part of GSK’s customary practice for its other products.

5.2

Manufacturing Technology Transfer.  Within [***] following the Effective Date, (a) the JDC will prepare and approve a Manufacturing technology transfer plan for the transfer from ITEOS or its Existing CMO of Know-How within the ITEOS Technology related to Manufacturing the Licensed Antibodies and Licensed Products, which plan will include a reasonable allocation of costs between the Parties (the “Manufacturing Tech Transfer

Plan”) and (b) the Parties will initiate performance of technology transfer activities to enable GSK to conduct Clinical Manufacturing and supply of Licensed Product or Licensed Antibodies. The JDC will manage and oversee the transfer of Know-How within the ITEOS Technology set forth in the Manufacturing Tech Transfer Plan.  Without limiting the foregoing, ITEOS will use reasonable efforts to facilitate GSK’s and ITEOS’s shared goal of an orderly transition and successful Manufacturing technology transfer in accordance with the timelines set forth in the Manufacturing Tech Transfer Plan and uninterrupted Development of the applicable Licensed Antibodies and Licensed Products in compliance with GMP requirements. The format of, and media for exchanging, any of the foregoing information shall be decided by the JDC and described in the Manufacturing Tech Transfer Plan. The Parties will complete the transfer of Manufacturing responsibility to GSK no later than [***].

5.3

Prioritization of Supply. Allocation of supply of any Licensed Antibodies or Licensed Products to either Party for Additional Development Activities shall be [***].

5.4

Supply of Other Products by GSK.  If the Global Development Plan includes Clinical Trials to be conducted by ITEOS for the Development of a [***], then (a) GSK will be responsible for supplying such [***], for use under the Global Development Plan and (b) the Parties will enter into a clinical supply agreement and a quality agreement (or add such [***] to the supply agreement previously entered into by the Parties pursuant to Section 5.1.4 (Request to Supply)), as necessary for GSK to [***] to ITEOS for the purpose of conducting the applicable Clinical Trials in accordance with the Global Development Plan. [***].

6.1

Global Strategic Launch Plan. No later than [***] prior to the Target BLA Filing Date, GSK will prepare a reasonably detailed written plan for the Licensed Product with respect to the [***] plans for the Licensed Product that sets out the [***] with respect to Licensed Products throughout the Territory, which plan will include at a minimum:  (a) [***] (the “Global Strategic Launch Plan”). The Global Strategic Launch Plan will serve as the basis for the Joint Commercialization Plan. The Global Strategic Launch Plan will be prepared having at least the same level and quality of information and in the same format as GSK ordinarily prepares for its own internal management for purposes of standard budget and portfolio reviews and project management, provided that GSK will not be obligated to include information that does not relate to the Licensed Products. At least once per Calendar Year, GSK will review and update, as appropriate, the Global Strategic Launch Plan. GSK will provide the initial Global Strategic Launch Plan for each Licensed Product, and each annual update thereto, to the JCC and the JSC for review and comment. ITEOS’s representatives on the JCC and the JSC may comment thereon and GSK will consider ITEOS’s comments in good faith, but the JCC and the JSC will not have an approval right with respect thereto. Notwithstanding the foregoing or any other provision to the contrary set forth in this Agreement, if ITEOS reasonably believes that any activity under a Global Strategic Launch Plan or update thereto or otherwise proposed to be conducted by GSK in the Net Sales Territory may reasonably give rise to a Material Safety or Commercialization Concern described in Section 1.171(b) or (c) (and excluding Section 1.171(a)) based on information known at the time, then ITEOS may raise such concern to the JCC and the JCC will promptly discuss and determine whether such activity may present a Material Safety or Commercialization Concern described in Section 1.171(b) or (c) (and excluding Section 1.171(a)), and whether such Material Safety or Commercialization Concern described in Section 1.171(b) or (c) (and excluding Section 1.171(a)) may be appropriately addressed in an update to the Joint Commercialization Plan.  If ITEOS reasonably believes that any activity under a Global Strategic Launch Plan or update thereto or otherwise proposed to be conducted by GSK in the Net Sales Territory may reasonably give rise to a Material Safety

or Commercialization Concern [***] for the Licensed Product or [***] to discuss and determine whether such activity may present a Material Safety or Commercialization Concern described in Section 1.171(a). If the JCC is unable to reach a decision that the resolution of such matter is appropriately addressed in the Joint Commercialization Plan within thirty (30) days of ITEOS raising such a Material Safety or Commercialization Concern described in described in Section 1.171(b) or in Section 1.171(c), then the issue will be resolved in accordance with Section 7.7.2(c) (Resolution of Material Concerns) or if the [***] are unable to resolve a Material Safety or Commercialization Concern described in Section 1.171(a), then, in each case, the issue will be resolved in accordance with Section 7.7.2(c) (Resolution of Material Concerns).

6.2

Joint Commercialization Plan. The JDC shall determine a target filing date of the BLA for the most advanced Licensed Product being Developed under this Agreement (the “Target BLA Filing Date”). No later than [***] of a Licensed Product in the Profit-Sharing Territory, GSK will provide to the JCC a draft initial joint commercialization plan and budget that sets out the Commercialization and Medical Affairs activities to be conducted by the Parties with respect to the Licensed Products in the Profit-Sharing Territory (the “Joint Commercialization Plan”). The Joint Commercialization Plan will be based upon and consistent with the Global Strategic Launch Plan for the applicable Licensed Product. Promptly thereafter, the JCC, with the support and direct involvement of the Financial Working Group with regard to preparation of the Joint Commercialization Budget, will review, discuss and recommend modifications to the draft Joint Commercialization Plan (provided, that only the medical representatives on the JCC may recommend modifications to the Medical Affairs activities set forth in the Joint Commercialization Plan), and the JCC will, in turn, provide such Joint Commercialization Plan (as such plan may be modified on the recommendation of the JCC) and Joint Commercialization Budget to the JSC to review, discuss and determine whether to approve. The Joint Commercialization Plan will (a) include matters similar to those included in the Global Strategic Launch Plan but revised to specifically support launch of the Licensed Product in the Profit-Sharing Territory, (b) [***] included in such plan to be undertaken for the upcoming Calendar Year which budget will be broken down by Calendar Quarter, for the estimated Commercial FTE Costs (for Commercialization activities), estimated Development FTE Costs (for Medical Affairs activities), Manufacturing Costs, and Out-Of-Pocket Costs expected to be incurred by each Party in the given Calendar Year with respect to such Medical Affairs and Commercialization activities set forth in such plan (such budget the “Joint Commercialization Budget”). So long as ITEOS is Commercializing with GSK the Licensed Products in the Profit-Sharing Territory under this Agreement, on at least an annual basis during the Term (or more frequently as may be

required), GSK will review and update each Joint Commercialization Plan (and Joint Commercialization Budget therein) based on the currently available information and data. GSK will provide to the JCC a copy of each such update to the Joint Commercialization Plan to (together with the Financial Working Group) review, discuss, and recommend modifications (provided, that only the medical representatives on the JCC may recommend modifications to the Medical Affairs activities set forth in the Joint Commercialization Plan), and the JCC will, in turn, provide such update to the Joint Commercialization Plan (as such update may be modified on the recommendation of the JCC) to the JSC to review, discuss and determine whether to approve. The initial Joint Commercialization Plan and each such update to the Joint Commercialization Plan will become effective and will supersede the previous Joint Commercialization Plan only upon approval thereof by the JSC. Any such updates or amendments to the Joint Commercialization Plan and Joint Commercialization Budget may be memorialized in the JCC and JSC meeting minutes until the next annual update to the Joint Commercialization Plan and Joint Commercialization Budget, at which time such updates or amendments will be added to the updated Joint Commercialization Plan and Joint Commercialization Budget.

6.3

Commercialization Responsibilities.

6.3.1

Net Sales Territory. During the Term, GSK, either itself or as it determines, by and through its Affiliates, Sublicensees or subcontractors, will be solely responsible for all Commercialization activities (including booking of sales) with respect to the Licensed Products throughout the Net Sales Territory, at GSK’s sole cost and expense, in accordance with the Global Strategic Launch Plan and this Article 6 (Commercialization; Medical Affairs). GSK will keep ITEOS reasonably informed, through periodic updates to the JSC, regarding key pricing and patient support programs in major countries or regions in the Net Sales Territory.

6.3.2

Profit-Sharing Territory. The Parties will jointly Commercialize the Licensed Products in the Profit-Sharing Territory in accordance with the Joint Commercialization Plan and this Article 6 (Commercialization; Medical Affairs). The Party to which a particular Commercialization activity is allocated under the Joint Commercialization Plan will lead the performance thereof and, without seeking JCC or JSC review or approval, but subject to this Article 6 (Commercialization; Medical Affairs), will have the right to make operational decisions with respect to the implementation and performance of such Commercialization activities to the extent consistent with the then-current Joint Commercialization Plan and this Article 6 (Commercialization; Medical Affairs). If a particular Commercialization activity is allocated to both Parties to perform jointly under the Joint Commercialization Plan, then both Parties will conduct such activity in collaboration with each other. GSK will book sales of all Licensed Products in the Profit-Sharing Territory and will be responsible for performing or approving, as applicable, the Excluded Commercialization Activities. Unless otherwise agreed by the JCC, the Joint Commercialization Plan will assign to ITEOS [***] percent [***] of the Shared Commercialization Activities for such Licensed Products in the Profit-Sharing Territory each Calendar Quarter. Without limiting the foregoing, ITEOS will have the right to participate in the [***]. Each

Party will conduct all Commercialization activities in the Profit-Sharing Territory in accordance with the Joint Commercialization Plan and this Article 6 (Commercialization; Medical Affairs).

6.4

Medical Affairs Responsibilities.

6.4.1

Net Sales Territory. During the Term, GSK, either itself or by and through its Affiliates, Sublicensees or subcontractors, will be solely responsible for all Medical Affairs activities with respect to the Licensed Products throughout the Net Sales Territory, at GSK’s sole cost and expense, in accordance with the Global Strategic Launch  Plan and this Article 6 (Commercialization; Medical Affairs).

6.4.2

Profit-Sharing Territory. The Party to which a particular Medical Affairs activity is allocated under a Joint Commercialization Plan will lead the performance thereof, and, without seeking JCC or JSC review or approval, will have the right to make operational decisions with respect to the implementation and performance of such Medical Affairs activities to the extent consistent with the then-current Joint Commercialization Plan and this Article 6 (Commercialization; Medical Affairs). If a particular Medical Affairs activity is allocated to both Parties to perform jointly under a Joint Commercialization Plan, then both Parties will conduct such activity in collaboration with each other. Each Party will use reasonable efforts in the Profit-Sharing Territory to [***] is permitted under Applicable Law and Guidelines. Each Party will conduct all Medical Affairs activities in the Profit-Sharing Territory in accordance with the Joint Commercialization Plan and this Article 6 (Commercialization; Medical Affairs).

6.4.3

Medical Affairs Materials.  GSK shall prepare and produce all Medical Affairs Materials for the Licensed Products in the Territory in accordance with the Global Strategic Launch Plan and the Joint Commercialization Plan, which Medical Affairs Materials GSK will share with ITEOS for ITEOS’s review and comment, which comments GSK will consider in good faith. GSK will be solely responsible for legal and regulatory review of such Medical Affairs Materials through its normal internal review process, and submission of Medical Affairs Content to applicable Regulatory Authorities for comments or approval as required. GSK shall own all rights, title and interests in and to any and all such Medical Affairs Materials.  Neither Party shall use any materials other than the Medical Affairs Materials that have undergone GSK’s internal review and approval process for use in connection with the conduct of Medical Affairs activities related to the Licensed Products under this Agreement; provided that, ITEOS will not be required to use any Medical Affairs Materials that ITEOS’s compliance team has not also approved. GSK shall be responsible for providing and shipping to ITEOS all Medical Affairs Materials in quantities necessary for ITEOS to perform its activities under the Joint Commercialization Plan.

6.4.4

Medical Affairs Training.  GSK shall be responsible for preparing the training programs and materials relating to Medical Affairs activities for the Licensed Product (“Medical Affairs Training Materials”) for the Parties’ Medical Affairs

personnel, which Medical Affairs Training Materials GSK will share with ITEOS for ITEOS’s review and comment, which comments GSK will consider in good faith. GSK shall conduct training programs regarding Medical Affairs activities for the Licensed Products based on such Medical Affairs Training Materials for all such Medical Affairs personnel of the Parties.  The Medical Affairs Training Materials will be updated annually taking into account any areas identified through internal monitoring of activities by each Party for enhanced or refreshed training.  Following the initial training of Medical Affairs personnel, each Party shall be responsible for, and shall conduct, regular training programs for its own Medical Affairs personnel using the most up-to-date Medical Affairs Training Materials. GSK shall have the right to join ITEOS Medical Affairs trainings and provide input. For the avoidance of doubt, the Medical Affairs Training Materials will include training on the USPPs. GSK shall own all rights in the Medical Affairs Training Materials in all formats (e.g., print, video, audio, digital, computer) including all applicable copyrights, trademarks, program names, domain names and Internet sites.  Each Party shall be responsible for the performance of its own Medical Affairs representatives.

6.5

Limited Disclosure. Nothing in this Agreement shall require GSK to disclose to ITEOS (a) [***] or (b) information pertaining to [***].

6.6

Diligence. Each Party will use Commercially Reasonable Efforts to perform the obligations assigned to it under the Joint Commercialization Plan. Upon receipt of the Regulatory Approval for a Licensed Product in the Field in a given country in the Territory, GSK (directly, or through its Affiliates, its or their Sublicensees or subcontractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such country in the Territory.

6.7

ITEOS Opt-Out.

6.7.1

ITEOS Opt-Out Right. Subject to Section 6.7.3 (Effects of Opt-Out), at any time during the Term, ITEOS may provide GSK with written notice indicating that ITEOS elects, in its discretion, not to Commercialize with GSK the Licensed Products in the Profit-Sharing Territory in accordance with the Joint Commercialization Plan and the requirements of this Agreement or share Development Costs or Pre-Tax Profit or Loss under this Agreement (such notice, an “Opt-Out Notice”). For the avoidance of doubt, any Opt-Out Notice shall terminate ITEOS’s right to both Commercialize and provide Medical Affairs activities in the Profit-Sharing Territory.

6.7.2

Forced Opt-Out. If (i) in connection with its conduct of Commercialization activities in the Profit-Sharing Territory, ITEOS materially breaches its obligations under Section 6.9 (Regulatory Compliance) and Section 6.10 (Marketing) to comply with the Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.) or any Applicable Laws, Guidelines or USPPs governing off-label promotion, pre-approval promotion or disguised promotion of pharmaceutical products in the Profit-Sharing Territory, (ii) ITEOS delivers less than [***] of the Details required

to be delivered by ITEOS under the Joint Commercialization Plan in any [***] Calendar Quarters, or (iii) ITEOS otherwise fails to provide such Commercialization activities that are specifically allocated to ITEOS  under the Joint Commercialization Plan in any [***] Calendar Quarters where ITEOS’s failure to do so is a material failure under ITEOS’s overall contribution of Commercialization activities as contemplated under the then-current Joint Commercialization Plan, then GSK will provide written notice to ITEOS of the occurrence of any such event described under clause (i), (ii) or (iii). Such notice will, in each case, expressly reference this Section 6.7.2 (Forced Opt-Out), reasonably describe the alleged breach or failure, and state GSK’s intent to terminate ITEOS’s right to Commercialize Licensed Products under this Agreement if such breach or failure is not cured or remediated in accordance with this Section 6.7.2 (Forced Opt-Out).

(a)

With respect to a material breach described in clause (i) of this Section 6.7.2 (Forced Opt-Out), ITEOS shall immediately cease its Commercialization activities relating to the alleged material breach, and propose to GSK within [***] after receipt of GSK’s notice of breach a comprehensive remediation plan designed to avoid similar breaches in the future and ensure compliance with such Applicable Laws, Guidelines and USPPs, which plan shall provide for immediate termination (at ITEOS’s sole cost and expense) of the employment of any ITEOS employees and contract with any Subcontractor, in each case, that have violated such Applicable Laws, Guidelines or USPPs, which remediation plan the Parties will discuss in good faith and agree upon. If GSK does not agree to ITEOS’s proposed remediation plan, then GSK will provide to ITEOS, [***], a comprehensive remediation plan (which may be a modified version of ITEOS’s proposed remediation plan) designed to avoid similar breaches in the future and ensure compliance with such Applicable Laws, Guidelines and USPPs. ITEOS will not resume the ceased Commercialization activities in the Profit-Sharing Territory until a comprehensive remediation plan has been agreed between the Parties or has been provided by GSK to ITEOS, as applicable. If ITEOS does not comply with the foregoing requirement to cease the applicable Commercialization activities and provide a remediation plan designed to avoid similar breaches in the future and ensure compliance with such Applicable Laws, Guidelines and USPPs, then, subject to Section 6.7.2(c), GSK may terminate ITEOS’s right to Commercialize in the Profit-Sharing Territory by providing written notice to ITEOS of such failure to comply with the provisions of this Section 6.7.2(a), and ITEOS’s right to Commercialize in the Profit-Sharing Territory will terminate [***] days after the breach notice has been provided for such material breach described in clause (i) of this Section 6.7.2 (Forced Opt-Out). Further, if ITEOS materially breaches any such comprehensive remediation plan agreed by the Parties  or provided by GSK, as applicable, or otherwise materially breaches its obligations to comply with the Anti-Kickback Statute (42 U.S.C. § 1320a-7b et seq.) or any Applicable Laws, Guidelines or USPPs governing off-label promotion, pre-approval promotion or disguised promotion of

pharmaceutical products in the Profit-Sharing Territory in respect of any resumed Commercialization activities in the Profit-Sharing Territory that were to be conducted under such an agreed or provided comprehensive remediation plan, then, subject to Section 6.7.2(c), GSK may terminate ITEOS’s right to Commercialize in the Profit-Sharing Territory immediately notice to ITEOS of such further material breach.

(b)

With respect to a failure described in clause (ii) or (iii) of this Section 6.7.2 (Forced Opt-Out), if by the end of the next [***] Calendar Quarters following the [***] Calendar Quarters in which the failure described in clause (ii) or (iii) of this Section 6.7.2 (Forced Opt-Out) occurred, ITEOS does not perform at least [***] percent [***] of the Details required to be delivered by it during such next [***] Calendar Quarters as set forth in the then-current Joint Commercialization Plan or ITEOS otherwise materially fails to perform its other Commercial Commercialization activities as had been contemplated under the then-current Joint Commercialization Plan for such next [***] Calendar Quarters, then ITEOS’s right to Commercialize in the Profit-Sharing Territory will terminate upon [***] notice provided by GSK following such subsequent failures in such subsequent [***] Calendar Quarters.

(c)

If there is a good faith dispute with respect to the existence of a material breach or failure or whether such material breach has been remediated or failure has been cured, and if such alleged material breach or failure to cure is contested in good faith by ITEOS in writing within [***] after the delivery of the notice of material breach or failure from GSK, then the dispute resolution procedure set forth in Article 16 (Dispute Resolution) may be initiated by ITEOS to determine whether a material breach or failure, or a failure to remediate or cure, has actually occurred. If either Party so initiates such dispute resolution procedure, then the applicable cure period and the corresponding occurrence of the Cost Share End Date, as applicable, will be tolled until such time as the dispute is finally resolved pursuant to Article 16 (Dispute Resolution).

6.7.3

Effects of Opt-Out. If ITEOS has delivered an Opt-Out Notice pursuant to Section 6.7.1 (ITEOS Opt-Out Right), or if ITEOS’s right to Commercialize in the Profit-Sharing Territory has terminated pursuant to Section 6.7.2 (Forced Opt-Out), then, notwithstanding any provision to the contrary set forth in this Agreement, the following effects of such opt-out will apply beginning: (i) (A) if delivered during the First No Opt-Out Period, then the later of [***] following delivery of the Opt-Out Notice or the day following end of the First No Opt-Out Period, (B) if delivered after the end of the First No Opt-Out Period but prior to Second No Opt-Out Period, then [***] following delivery of the Opt-Out Notice, (C) if delivered during or following the Second No Opt-Out Period, then the later of [***] following delivery of the Opt-Out Notice or the day following the end of the Second No Opt-Out Period, or (ii) on the applicable effective date of the termination of ITEOS’s right

to Commercialize in the Profit-Sharing Territory as set forth in Section 6.7.2 (Forced Opt-Out) ((i) or (ii), as applicable, the “Cost Share End Date”):

(a)

sharing of Development Costs incurred in connection with the performance of Shared Global Development Activities under the Global Development Plan and of the Pre-Tax Profit or Loss in the Profit-Sharing Territory in accordance with the relevant provisions of this Agreement will no longer apply with respect to any of the Licensed Antibodies and Licensed Products; provided that ITEOS shall continue to be responsible for its portion of the Development Costs up to the Committed Development Spend that has not yet been expended in connection with the Committed Studies (whether or not such Committed Studies have commenced as of the Cost Share End Date and as these may be amended or replaced with comparable Clinical Trials of similar scope through an update to the Global Development Plan in accordance with Section 3.2.1 (Global Development Plan)) and any other Clinical Trials that the Parties agree to include in the Global Development Plan prior to the Cost Share End Date that can be conducted within the Committed Development Spend; provided, further that the maximum amount of the Committed Development Spend to be incurred by ITEOS is [***], and if the Committed Studies and other Clinical Trials that the Parties agreed to include in the Global Development Plan prior to the Cost Share End Date cost less than the Committed Development Spend, then ITEOS shall be responsible for only its portion of such lesser amount;

(b)

with respect to any on-going Additional Development Activities conducted by GSK, the costs of undertaking such Development would not be subject to sharing between the Parties;

(c)

the Net Sales Territory will automatically be amended to include the entire Territory;

(d)

obligations under this Agreement relating solely to the Profit-Sharing Territory, including obligations regarding the preparation and approval of the Joint Commercialization Plan and corresponding Joint Commercialization Budget, will no longer be applicable;

(e)

where the JSC, JCC, or JDC, respectively, had an approval right, such approval right will automatically be converted into a review and comment, but not approval, right.

6.7.4

Effects of Forced Opt-Out. Notwithstanding any provision to the contrary set forth in this Agreement, if ITEOS’s right to Commercialize Licensed Products in the Profit-Sharing Territory is terminated pursuant to Section 6.7.2(a), then the effects of opt-out set forth in Section 6.7.3 (Effects of Opt-Out) will apply, except that, (a) [***]. If, following ITEOS’s right to Commercialize Licensed Products in the Profit-Sharing Territory being terminated pursuant to Section 6.7.2(a), ITEOS delivers an Opt-Out Notice pursuant to Section 6.7.1 (ITEOS Opt-Out Right), then

all effects of opt-out set forth in Section 6.7.3 (Effects of Opt-Out) will apply in accordance with their terms, and the effects of forced opt-out set forth in this Section 6.7.4 (Effects of Forced Opt-Out) will no longer apply.  

6.8

Commercialization Reporting. During the Term, with respect to any Medical Affairs and Commercialization activities conducted by or on behalf of either Party with respect to the Licensed Products under this Agreement, within [***] following the end of each [***], each Party shall prepare and provide to the other Party and the JCC (or the JSC, if the JCC is no longer meeting) a written report that summarizes the material Medical Affairs and Commercialization activities performed with respect to the Licensed Products in the Territory and the status of activities and progress with respect to the information included in each applicable Commercialization Plan, and shall identify any issues or circumstances of which it is aware that may prevent or adversely affect in a material manner its future performance of activities assigned to it under the then-current Commercialization Plans (each, a “Commercialization Report”). Solely in the event that, and for so long as, the effects of forced opt-out set forth in Section 6.7.4 (Effects of Forced Opt-Out) apply, the Commercialization Reports provided by GSK to the JSC pursuant to this Section 6.8 (Commercialization Reporting) will include GSK’s [***] ITEOS’s JSC representatives may review, but will have no right to comment on or approve. Each Party will respond to the reasonable questions or requests of the other Party’s JCC representatives (or JSC representatives, if the JCC is no longer meeting), as applicable, for additional information relating to such Party’s Medical Affairs or Commercialization activities under this Agreement in a timely manner.

6.9

Compliance.

6.9.1

Establishment of Compliance Program. The compliance officers (or equivalent personnel) from each Party with responsibility for Commercialization and Medical Affairs (the “Compliance Officers”) will meet to align on a compliance program applicable to the Licensed Products in the Profit-Sharing Territory, that will include the concepts set forth in this Section 6.9 (Compliance) along with the requirement to perform regular risk assessments relating to the Commercialization and Medical Affairs activities undertaken by the applicable Party in the Profit-Sharing Territory (the “Compliance Program”). The Compliance Program will be presented to the JCC for review and discussion.  Each Party will ensure that it will perform, and will ensure that each of its Affiliates, Sublicensees, and subcontractors perform, all Commercialization and Medical Affairs activities in a professional and ethical business manner and in compliance with the Compliance Program and the Approved Labeling and each Party will provide appropriate training to its employees, Sales Representatives, Affiliates, Sublicensees and subcontractors on the foregoing, except where GSK provides such training to ITEOS under this Article 6 (Commercialization; Medical Affairs).

6.9.2

Compliance Resourcing. In order to ensure adherence to the Compliance Program across all Commercialization and Medical Affairs activities, each Party will maintain resources sufficient to conduct at least the following activities: (a) assess such Party’s compliance with any pre-established criteria set forth in the

Compliance Program, (b) ensure upward reporting and escalation processes that provide positive assurance regarding the management of significant risks that are communicated to senior leadership or risk oversight committees, (c) provision of training on Commercialization and Medical Affairs activities within the scope of such Party’s responsibilities under the applicable Joint Commercialization Plan, including on Applicable Laws, Guidelines and USPPs, as applicable, as set out in this Article 6 (Commercialization; Medical Affairs) (d) monitoring and updating of training programs described under (c), and provision of refresher training on a regular basis, (e) maintenance of a speak-up hotline to report violations of compliance, and (f) conducting robust investigations of any suspected compliance violations by trained independent individuals with relevant functional experience and skill.

6.9.3

Applicable Laws and Guidelines.  Each Party shall conduct its Commercialization activities under this Agreement in accordance with the requirements of this Agreement, Applicable Laws and Guidelines and shall cooperate with one another in any efforts toward ensuring that government reporting (including price and honoraria reporting), sales, marketing and promotional practices in respect of the Licensed Products meet the standards required by: (a) Applicable Laws; and (b) applicable guidelines concerning the advertising and promotion of prescription drug products, including the Office of the Inspector General’s (“OIG”) Compliance Guidance Program issued in 2003, the American Medical Association (the “AMA”) Guidelines on Gifts to Physicians, the Pharmaceutical Research and Manufacturers of America (“PhRMA”) Code on Interactions with Healthcare Professionals, as hereafter amended from time to time (the “PhRMA Code”), the PhRMA Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, and the standards set forth by the Accreditation Council for Continuing Medical Education relating to educating the medical community in the United States (“ACCME Standards”), in each case, to the extent applicable to the Parties’ activities hereunder and as may be amended or supplemented from time to time (such guidelines as set forth in this Section 6.9(b), the “Guidelines”).  In addition, each Party shall obtain and maintain all licenses, permits, approvals and other authorizations applicable to it in order to enable it to perform its respective obligations hereunder.  The Parties shall cooperate in good faith to update their obligations under this Section 6.9 (Compliance) from time to time to reflect any changes in any of the foregoing (a) – (b) or to resolve any conflicts in any of the foregoing standards as applied to the Parties’ activities under this Agreement. Each of the Parties agrees and acknowledges that it shall comply, and shall ensure that its applicable Affiliates and its and their respective employees, officers, directors and consultants comply, with the applicable requirements of this Section 6.9.3 (Applicable Laws and Guidelines).

6.9.4

Business Practices.  The Parties shall perform all of their Commercialization and Medical Affairs activities undertaken in the Profit-Sharing Territory in accordance with GSK’s policies regarding the same, known as of the Effective Date as the US Practices Policies, that are provided to ITEOS by GSK, along with any updates thereto (the “USPPs”); provided that, with respect to updates to the USPPs, ITEOS

shall use reasonable efforts to give effect to any updates to the USPPs as soon as reasonably practicable following receipt of such updates from GSK. Notwithstanding anything to the contrary in this Agreement, neither Party nor any of its Affiliates shall be required to take, or shall be deemed in breach of this Agreement for not taking, any action that is not in compliance with such Party’s Internal Policies (so long as such action is still compliant with Applicable Laws and Guidelines) or that such Party reasonably believes is not in compliance with Applicable Laws, Guidelines or the USPPs.  

6.9.5

Reporting.  Each Party shall be responsible for calculating, tracking and reporting transfers of value initiated and controlled by its employees or contractors pursuant to its respective obligations under the requirements of Section 6002 (Transparency Reports and Reporting of Physician Ownership and Investment Interest) of the Patient Protection and Affordable Care Act, commonly referred to as the “Sunshine Act”, and applicable state marketing reporting laws.  Subject to Applicable Laws and Guidelines, the value reported to the Centers for Medicare & Medicaid Services (“CMS”) shall be the amount expended by the controlling Party, irrespective of the division of or reconciliation of expenses between the Parties.

6.9.6

Information.  Each of GSK and ITEOS shall reasonably cooperate with the other Party to provide the other Party reasonable access to information and reports related to the Licensed Products reasonably required by the other in order to comply with the relevant provisions of the Medicare Modernization Act, as amended from time to time, and any other Applicable Laws and Guidelines, including reporting requirements, in a timely and appropriate manner.  Each Party shall ensure that its reporting to CMS and other federal and state healthcare programs related to the Licensed Products is true, complete and correct in all material respects; provided, however, that neither Party shall be held responsible for submitting erroneous reports if such deficiencies result from information provided by the other Party which itself was not true, complete and correct.  Each Party shall notify the other Party promptly upon becoming aware of any Licensed Product-related inquiries or document requests by any Regulatory Authority, or claims or threatened claims related to the Licensed Product.

6.9.7

Cooperation.  At the request of either Party, the Parties’ Compliance Officers will convene for purposes of discussing the Compliance Program and resourcing and to share best practices, and if such discussions result in modifications to the Compliance Program, then such modifications shall be presented to the JCC for review and discussion in accordance with Section 6.9.1 (Establishment of Compliance Program).  Notwithstanding the foregoing, if a Party becomes aware of an allegation of a significant violation of Applicable Laws or Guidelines or USPPs, such Party shall promptly investigate and timely notify the other Party’s Compliance Officer and General Counsel of the commencement of the investigation.  If the investigation is conducted in accordance with the attorney-client privilege, then such notification shall be made pursuant to a joint-defense agreement in order to maintain all attorney-client privilege protections.  Such notification shall occur within two (2) Business Days of a Party becoming aware of an allegation of such a violation.

6.9.8

Audit and Monitoring Rights.  GSK shall have the following rights with respect to ITEOS’s performance of Commercialization and Medical Affairs activities:

(a)

GSK or its duly authorized Third Party auditor shall upon [***] notice and no more frequently than once every [***] have the right during normal business hours at a time to be agreed by the Parties for the duration of the Profit-Sharing Term and for a period of [***] following the termination or expiration of the Profit-Sharing Term for any reason, to examine and copy such books and records and all other documents and materials in the possession of or under the control of ITEOS relating to the conduct of all Commercialization and Medical Affairs activities undertaken by ITEOS under this Agreement. ITEOS shall ensure that GSK has similar audit rights for any subcontractor used by ITEOS to perform Detailing activities as described in Section 6.12 (Subcontracting).  GSK or its third-party auditor shall have access to ITEOS’s facilities, shall be allowed to interview current or former employees of ITEOS with respect to the conduct of Commercialization and Medical Affairs activities under of this Agreement, shall have access to all applicable necessary records and shall be furnished adequate and appropriate workspace in order to perform the examinations provided for herein. GSK’s costs for any such on-site audit shall be borne by GSK. Notwithstanding the foregoing, where GSK has a good faith belief that a violation of the Compliance Program has occurred or will occur if appropriate actions are not taken then GSK or its duly authorized third-party auditor may request an audit with only [***] notice regardless of the timing or occurrence of any previous audit; and

(b)

GSK shall have the right to monitor Sales Representatives and Medical Affairs personnel of ITEOS in the field to assess, inter alia, compliance with Applicable Laws, Guidelines and USPPs and to identify gaps or weaknesses in knowledge or application of Applicable Laws, Guidelines and USPPs to the conduct of the applicable activity (the “Field Monitoring”). Such Field Monitoring shall be conducted on regular intervals as agreed by the Parties but at least quarterly and shall be at GSK’s cost. Notwithstanding the foregoing, where GSK has a good faith belief that that a violation of the Compliance Program has occurred or will occur if appropriate actions are not taken then GSK may request to conduct Field Monitoring outside of the quarterly assessments on only [***] notice regardless of the timing or occurrence of any previous Field Monitoring session.  

(c)

Any and all reports from the audits set forth in (a) above or from the Field Monitoring sessions set forth in (b) above shall be shared with ITEOS and discussed by the Compliance Officers as set forth in Section 6.9.7 (Cooperation).

6.10

Marketing.

6.10.1

Advertising and Promotional Materials.  GSK shall prepare and produce all Marketing Materials (including Promotional Materials) for the Licensed Products in the Territory in accordance with the Global Strategic Launch Plan and the Joint Commercialization Plan and as otherwise agreed by the JCC. ITEOS may also propose Promotional Materials for Licensed Products in the Profit-Sharing Territory in accordance with the Joint Commercialization Plan and as otherwise agreed by the JCC. Each Party will share Promotional Materials with the other Party for consideration, and will reasonably consider the input from the other Party in good faith. Notwithstanding the foregoing, GSK will be solely responsible for legal and regulatory review of all such Marketing Materials (regardless of which Party created such materials) through the GSK standard copy approval process and submission of materials to applicable Regulatory Authorities for comments or approval as required. GSK shall own all rights, title and interests in and to any and all such Marketing Materials (including Promotional Materials).  Neither Party shall use any materials other than the Marketing Materials (including Promotional Materials) that have undergone GSK’s copy approval process for use in connection with the Commercialization and Detailing of the Licensed Products under this Agreement; provided that ITEOS will not be required to use any Marketing Materials (including Promotional Materials) that ITEOS’s compliance team has not also approved. GSK shall be responsible for providing and shipping to ITEOS all Marketing Materials (including Promotional Materials) in quantities necessary for ITEOS to perform its activities under the Joint Commercialization Plan.

6.10.2

Branding. The Marketing Materials (including Promotional Materials) will contemplate branding that acknowledges ITEOS’s role in discovering the Licensed Products, [***] in the Profit-Sharing Territory where permitted by Applicable Law.  GSK will use reasonable efforts to include an agreed-upon standard [***].  

6.10.3

Sales Representatives.  Each Party shall have sole responsibility for all costs and expenses in connection with its own Sales Representatives and its related management, including salaries, travel expenses and other expenses, credentialing, licensing, providing benefits, deducting federal, state and local payroll taxes, Federal Insurance Contributions Act contributions, Federal Unemployment Insurance, State Unemployment Insurance and any similar taxes and paying workers’ compensation premiums, unemployment insurance contributions and any other payments required by Applicable Laws to be made on behalf of its employees. Notwithstanding the foregoing, the Parties will share (50:50) Commercial FTE Costs incurred in connection with Commercializing the Licensed Products in the Profit-Sharing Territory as set forth on Schedule 8.3.1 (Pre-Tax Profit and Loss Sharing). Nothing in this Agreement shall be construed to conclude that any of a Party’s Sales Representatives or any other agents or employees of such Party are agents or employees of the other Party or subject to such other Party’s direction and control.  Each Party shall have sole authority over the terms and conditions of employment of its own Sales Representatives, including their selection, management, compensation (provided that the basis on which Sales

Representatives are compensated shall be aligned between the Parties to ensure compliance with the USPPs) and discharge. Any and all Detailing performed by a Party hereunder shall be tracked using such Party’s internal recording of such activity; provided that such tracking shall be on the same basis as such Party’s measurement for its Sales Representatives detailing of its other products, consistently applied throughout the Term and such tracking will be shared at the JCC for review and discussion to measure compliance with each Party’s obligations under the Joint Commercialization Plan.

6.10.4

Product Specific Training.  GSK shall be responsible for preparing the initial Licensed Product training programs and materials (“Product Training Materials”) for both its own Sales Representatives as well as the ITEOS’s Sales Representatives, and shall conduct such training programs for all Sales Representatives prior to the launch of the applicable Licensed Product; provided that thereafter each Party shall be responsible for, and shall conduct, training programs using the most up-to-date Product Training Materials for its own Sales Representatives who will participate in Detailing the Licensed Product using the Product Training Materials to ensure a consistent, focused promotional strategy between the Parties that is consistent with the Approved Labeling for the applicable Licensed Product. The Product Training Materials will be updated annually taking into account any areas identified through internal monitoring of activities by each Party for enhanced or refreshed training.  For the avoidance of doubt, the Product Training Materials will include training on the USPPs. GSK shall own all rights in the Product Training Materials in all formats (e.g., print, video, audio, digital, computer) including all applicable copyrights, trademarks, program names, domain names and Internet sites.  Each Party shall be responsible for the performance of its own Sales Representatives.  

6.11

Product Marks. GSK shall select, obtain and maintain any Product Marks for Licensed Products. Prior to selecting any Product Marks for Licensed Products, GSK will present the trademarks that it is considering for selection along with any relevant related reports or information to the JCC for review and discussion at a regularly scheduled meeting of the JCC. In addition, upon reasonable request of GSK, ITEOS shall provide reasonable assistance in the selection of Product Marks for a Licensed Product. As between the Parties, GSK shall be the owner of the Product Marks for any Licensed Product. GSK will and hereby does grant ITEOS the right to use such Product Marks, and the Marketing Materials (including Promotional Materials), to perform Medical Affairs activities and to Commercialize the Licensed Products in the Profit-Sharing Territory in accordance with this Agreement and as set forth in the Joint Commercialization Plan.

6.12

Subcontracting.  ITEOS may engage a Third Party subcontractor to provide Sales Representatives to conduct Detailing activities solely in accordance with the terms set forth in this Section 6.12 (Subcontracting). ITEOS shall not engage any Third Party subcontractors to perform any of its obligations under the Joint Commercialization Plan without the prior written consent of GSK.  Any subcontractor approved by GSK that performs Detailing activities in the Profit-Sharing Territory during the Term prior to the Cost Share End Date will be set forth in the Joint Commercialization Plan and shall meet

the qualifications typically required by GSK for Sales Representatives employed or engaged by GSK.  Prior to executing an agreement with a Third Party subcontractor that will perform Detailing activities on behalf of ITEOS hereunder, ITEOS will (a) provide GSK with an opportunity to review and comment on the material terms, (b) ensure that such agreement includes all of the requirements and obligations of Article 6 (Commercialization; Medical Affairs), including compliance, use of materials, training obligations, and ability to terminate in accordance with the provisions of Section 6.7 (ITEOS Opt-Out), and (c) require the Third Party subcontractor to comply with Applicable Law, Guidelines and USPPs and affords GSK the right to audit and perform Field Monitoring with respect to such subcontractor’s Detailing activities in substantially the same manner as provided in Section 6.9.8 (Audit and Monitoring Rights). Upon execution of any such contract with such Third Party subcontractor, ITEOS will provide GSK with a copy of such agreement.

7.1

Joint Steering Committee.

7.1.1

Establishment of JSC.  No later than [***] after the Effective Date, the Parties shall establish a Joint Steering Committee (“Joint Steering Committee” or “JSC”), which shall be constituted in accordance with Section 7.6 (Membership, Meetings, and Meeting Minutes).  The JSC shall operate in accordance with the provisions of Section 7.6 (Membership, Meetings, and Meeting Minutes) and Section 7.7 (Decision-Making). At its meetings, the JSC shall review, discuss and determine whether to approve (as appropriate and necessary), the matters described in Section 7.1.2 (Responsibilities of the JSC) or such other matters as are reasonably requested by either Party.

7.1.2

Responsibilities of the JSC.  The JSC shall perform the following functions:

(a)

oversee and guide the overall strategic direction of the Development Program (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein);

(b)

establish, as appropriate, additional Subcommittees or working groups responsible for managing specific aspects of the Development Program as contemplated herein;

(c)

oversee and supervise the Subcommittees and resolve issues or Disputes elevated to it by the JDC, JCC, Financial Working Group, or any subcommittee the JSC may establish;

(d)

review, discuss and determine whether to approve the Global Development Plan and Global Development Budgets and all updates thereto, as submitted by the JDC, as described in Section 3.2.1 (Global Development Plan);

(e)

resolve any dispute of the JDC regarding whether any GSK Sole Development Activity raised by ITEOS presents a Material Safety or Commercialization Concern described in Section 1.171(b) or (c) (and excluding Section 1.171(a)), as provided in Section 3.1.2 (Development for the Net Sales Territory);

(f)

resolve any dispute of the JDC regarding whether any Development activity set forth in an Additional Development Proposal and raised by either Party presents a Material Safety or Commercialization Concern, described in Section 1.171(b) or (c) (and excluding Section 1.171(a)), as provided in Section 3.5.2 (Material Adverse Development);

(g)

review, discuss and determine whether to approve Additional Development Proposals, as described in Section 3.4.1 (Additional Development Proposals);

(h)

review, discuss and comment on the Global Strategic Launch Plan and updates thereto, as described in Section 6.1 (Global Strategic Launch Plan);

(i)

review, discuss and determine whether to approve the Joint Commercialization Plan and Joint Commercialization Budget and all updates thereto, as submitted by the JCC, as described in Section 6.2 (Joint Commercialization Plans);

(j)

resolve any disputes of the JCC regarding whether any Medical Affairs or Commercialization activity set forth in a Global Strategic Launch Plan and raised by ITEOS presents a Material Safety or Commercialization Concern, described in Section 1.171(b) or (c) (and excluding Section 1.171(a)), as provided in Section 6.1 (Global Strategic Launch Plan);

(k)

coordinate with the Financial Working Group, JDC or JCC, as appropriate, with respect to the reconciliation or approval, as applicable, of Development Costs, Development Excess Costs, Commercialization Excess Costs, and the Pre-Tax Profit or Loss;

(l)

provide a forum for GSK to update ITEOS on key [***] in major countries or regions in the Net Sales Territory, with respect to each Licensed Product; and

(m)

perform such other functions as are assigned to the JSC in this Agreement, or otherwise agreed by the Parties in writing.

7.1.3

Term of the JSC.  The JSC shall meet in accordance with Section 7.6.2 (Meetings) for the Term.

7.2

Joint Development Committee.

7.2.1

Establishment of the JDC.  No later than [***] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or “JDC”) to oversee the conduct of, and coordinate the Parties’ activities with respect to the Development of Licensed Antibodies and Licensed Products under this Agreement (the “Development Program”), and coordinate on the execution of the Global Development Plan (in accordance with the Global Development Budget).

7.2.2

Responsibilities of the JDC.  The JDC shall perform the following functions for the Development Program:

(a)

oversee, review, discuss and coordinate the conduct and progress of the Development activities (including Manufacturing-related Development activities) of the applicable Licensed Antibody or Licensed Product, as described in the Global Development Plan (in accordance with the Global Development Budget), as well as any identified issues or circumstances that may prevent or adversely affect in a material manner a Party’s future performance of activities assigned to it under the then-current Global Development Plan;

(b)

review, discuss, and propose modifications to, the Global Development Plan and Global Development Budgets and all updates thereto, and submit such plans, budgets, and updates to the JSC for approval, as described in Section 3.2 (Global Development Plan);

(c)

determine whether any GSK Sole Development Activity raised by ITEOS presents a Material Safety or Commercialization Concern, as described in Section 3.1.2 (Development for the Net Sales Territory);

(d)

review and discuss the Data from Proof of Concept Trials conducted by a Party as Additional Development Activities and determine whether to amend the Global Development Plan to include the remainder of the applicable Additional Development Activities, as further described in Section 3.4.3(b) (Proof of Concept Data);

(e)

determine whether any Development activity set forth in an Additional Development Proposal and raised by either Party presents a Material Safety or Commercialization Concern, as described in Section 3.5.2 (Material Adverse Development);

(f)

review and discuss Additional Development Proposals, as described in Section 3.4.1 (Additional Development Proposals) and Section 3.5.3 (Limitation On Third Party Combinations) and Data and intellectual property arising out of Additional Development Activities, as described in Section 3.4.3(a) (Independent Development Activities);

(g)

discuss and develop a remediation strategy for material deficiencies regarding animal care and welfare, as described in Section 3.11.6.

(h)

review the compliance plan submitted to the JDC pursuant to Section 3.13 (R&D Ethics & Compliance) and agree to any modifications, and document the final agreed Development compliance plan in the JDC minutes;

(i)

oversee the implementation of the Global Development Plan, and monitor whether activities thereunder are performed in accordance with the timelines set forth therein and the terms set forth in Article 3 (Development Program);

(j)

review and discuss Data and information arising from Development activities for the Licensed Antibodies and Licensed Products, including Additional Development Activities, undertaken under this Agreement;

(k)

review and discuss regulatory matters relating to Development activities for the Licensed Antibodies and Licensed Products, including Additional Development Activities, undertaken under this Agreement and oversee the implementation of, and discuss progress regarding, the regulatory strategy set forth in the Global Development Plan;

(l)

coordinate with the Financial Working Group with respect to the reconciliation of Development Costs, and review and determine whether to approve Excess Development Costs and other budget overruns in consultation with the Financial Working Group, in accordance with Section 8.2 (Sharing of Development Costs);

(m)

review and discuss Development Reports;

(n)

in consultation with the Financial Working Group, oversee CMC Development, supply chain strategy, establishment of Manufacturing sources, capacity, supply chains, and Manufacture of Licensed Antibodies and Licensed Products, as described in Section 5.1.1 (JDC Oversight; Efforts);

(o)

prepare and determine whether to approve the Manufacturing Tech Transfer Plan (including choosing the format and media for such transfer) and manage and oversee the transfer of Know-How set forth in the Manufacturing Tech Transfer Plan, as described in Section 5.2 (Manufacturing Technology Transfer);

(p)

prepare the Publication Strategy, and, with consultation from the Patent Liaisons, where applicable, review and approve such Publication Strategy, and amend it from time to time upon agreement of the Parties, as described in Section 10.8.1 (Publication Strategy); and

(q)

perform such other functions as are specifically designated to the JDC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement.

7.2.3

Term of the JDC.  The JDC for the Development Program shall meet in accordance with Section 7.6.2 (Meetings) for so long as GSK and ITEOS are sharing Development Costs under the Global Development Plan. Following the Cost Share End Date, any [***], and any responsibilities of the [***].

7.3

Joint Commercialization Committee. The JCC shall perform the following functions:

7.3.1

Establishment of JCC.  No later than the [***] for a Licensed Product, the JSC will establish a joint commercialization committee (a “Joint Commercialization Committee” or “JCC”) for the Licensed Products. The JCC will be composed of both medical and commercial representatives from each Party. It is expected that the JCC will create a collaborative forum for sharing of information and robust discussions and input on the activities set forth in Section 7.3.2 (Responsibilities of the JCC), as well as Shared Commercialization Activities.  Such information and activities are expected to include, for example, [***].