Exhibit 10.1**
Certain information (indicated by “[***]”) and schedules have been excluded from this agreement because such information (i) is not material and (ii) would be competitively harmful if publicly disclosed.
COLLABORATION AND LICENSE AGREEMENT
Between
GLAXOSMITHKLINE INTELLECTUAL PROPERTY (No. 4) LIMITED
And
ITEOS belgium s.a.
Table of Contents
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 |
SCHEDULES
SCHEDULE 1.84 – EOS-448 Antibody
SCHEDULE 1.250 – Third Party Component Contracts
SCHEDULE 3.2 – Initial Global Development Plan
SCHEDULE 3.12 – Form of Material Transfer Record
SCHEDULE 8.3.1 – Pre-Tax Profit or Loss Schedule
SCHEDULE 8.11 – Form of Invoice
SCHEDULE 10.6 – Press Release
SCHEDULE 14.2.1 – ITEOS Background Patents
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (the “Agreement”) is made and entered into as of June 11, 2021 (“Execution Date”) and is effective as of the Effective Date (as defined below), between GLAXOSMITHKLINE INTELLECTUAL PROPERTY (No. 4) LIMITED, a company registered in England and Wales (registered number 11721880) and having business offices at 980 Great West Road, Brentford, Middlesex TW8 9GS United Kingdom (“GSK”), and iTeos Belgium S.A., a public limited company having an office at Rue des Frères Wright, 29, B-6041 Gosselies Belgium (“ITEOS”). GSK and ITEOS are sometimes referred to individually as a “Party” and collectively as the “Parties.”
BACKGROUND
WHEREAS, GSK, among other things, conducts programs to discover, develop, manufacture and commercialize innovative pharmaceutical medicines;
WHEREAS, ITEOS, among other things, conducts programs to discover and develop therapeutic products for the treatment and prevention of diseases; and
WHEREAS, GSK and ITEOS desire to enter into this Agreement to collaborate with respect to the Development Program and the Commercialization of Licensed Products that may result therefrom, consistent with the terms and conditions set forth herein.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.
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). |
1.9 | “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. |
1.15 | “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. |
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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). |
1.21 | “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. |
1.23 | “Breaching Party” has the meaning set forth in Section 12.3.1 (Termination for Material Breach). |
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 |
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1.35 | “CMS” has the meaning set forth in Section 6.9.5 (Reporting). |
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a Combination Product hereunder unless such Co-Administration Therapy is sold and invoiced under a single invoiced price. |
1.40 | “Collaboration In-License” has the meaning set forth in Section 9.11.3 (New Collaboration In-Licenses). |
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). |
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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). |
1.51 | “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). |
1.55 | “Compliance Officers” has the meaning set forth in Section 6.9.1 (Establishment of Compliance Program). |
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1.67 | [***]. |
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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). |
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1.82 | “EMA” means the European Medicines Agency, or any successor entity thereto performing similar functions for the European Union. |
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. |
1.88 | “Excluded Commercialization Activities” has the meaning set forth in Section 1.236 (Shared Commercialization Activities). |
1.93 | “Expansion” has the meaning set forth in Section 1.203 (Phase 2 Adaptive Study). |
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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. |
1.100 | “First No Opt-Out Period” means, with respect to a Licensed Product, the time period commencing on the Effective Date and ending on [***]. |
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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. |
1.105 | “GAAP” means generally acceptable accounting standards, principles, and procedures as issued by the Financial Accounting Standards Board (FASB). |
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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. |
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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). |
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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. |
1.124 | “GSK Sole Development Activities” has the meaning set forth in Section 1.108 (Global Development Plan). |
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1.131 | “IFRS” means the International Financial Reporting Standards as adopted by the United Kingdom, applied on a consistent basis. |
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. |
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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. |
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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). |
1.163 | “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. |
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Manufacturing Cost shall not include capital costs or costs associated with physical plant improvements. Subject to the foregoing, all Manufacturing Costs shall be calculated on a pro-rata basis based on the use of the components of Manufacturing activities devoted to the Licensed Products as opposed to all other products using the same components. In addition, Manufacturing Costs shall exclude costs that result from the gross negligence or willful misconduct of a Party, its Affiliates, Sublicensees or Third Party manufacturers or a failure by a Party, its Affiliates, Sublicensees or Third Party manufacturers to follow the documented manufacturing process or any other Manufacturing defect arising from such Manufacture of the applicable Licensed Product.
1.168 | “Manufacturing Tech Transfer Plan” has the meaning set forth in Section 5.2 (Manufacturing Technology Transfer). |
1.171 | “Material Safety or Commercialization Concern” means, with respect to an activity for a Licensed Antibody or Licensed Product, that such activity may [***]. |
1.174 | “Materials Transferring Party” has the meaning set forth in Section 3.12.1 (Material Transfers). |
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1.180 | “Negotiation Period” has the meaning set forth in Section 3.5.3 (Limitation On Third Party Combinations). |
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[***]
Upon any sale or other disposal of the Licensed Product that should be included within Net Sales for any consideration other than an exclusively monetary consideration on bona fide arm’s length terms, then for purposes of calculating the Net Sales under this Agreement, the Licensed Product shall be deemed to be sold exclusively for money at the average sales price during the applicable reporting period generally achieved for the Licensed Product in the country in which such sale or other disposal occurred.
Notwithstanding the foregoing, (i) Net Sales shall not include disposals of the Licensed Product for, or use of the Licensed Product in, clinical or pre-clinical trials undertaken as part of Development contemplated under this Agreement, given as free samples, or distributed at no charge to patients unable to purchase the Licensed Product, and (ii) Net Sales shall not include amounts for any Licensed Product distributed for compassionate, named patient or similar use provided at a price no greater than GSK’s Manufacturing Costs for such Licensed Product for such purpose.
The Licensed Products that will be Developed under this Agreement are anticipated to be sold either as: (1) a Licensed Product with a sole active ingredient that may be co-administered with other products (for example, the EOS-448 Sole Active Product, which is not a Combination Product under this Agreement), (2) a Combination Product that is in a single formulation finished form (i.e., a co-formulated Licensed Product) (a “Co-Formulated Product”), or (3) other Combination Products.
In the event of (X) a Combination Product sale in a country where not all of the active ingredient components in that Combination Product are also sold separately in that country (as sole active ingredient products), or (Y) a Combination Product sale that is a Co-Formulated Product, then the Net Sales of such Combination Product for the purposes of determining royalty payments and ROW Net Sales Milestones and U.S. Net Sales Milestones, as well as with respect to the calculation of Net Sales of Combination Products for the purpose of determining Pre-Tax Profit or Loss for the Profit-Sharing Territory (if applicable), shall be determined by [***].
In the event of a sale of a Combination Product that is not a Co-Formulated Product in a country where all of the active ingredient components in that Combination Product are also sold separately in that country (as sole active ingredient products), then the Net Sales of such Combination Product, for the purposes of determining royalty payments and ROW
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Net Sales Milestones and U.S. Net Sales Milestones, as well as also with respect to the calculation of Net Sales of Combination Products for the purpose of determining Pre-Tax Profit or Loss for the Profit-Sharing Territory (if applicable), shall be determined by multiplying the Net Sales of such Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Licensed Product containing the relevant Licensed Antibody(ies) as the sole active ingredient(s) when sold separately in finished form in such country and B is the weighted average sale price in that country of the product containing Other Components as the sole active ingredient when sold separately in finished form.
1.183 | “Non-Breaching Party” has the meaning set forth in Section 12.3.1 (Termination for Material Breach). |
1.185 | “Notice Period” has the meaning set forth in Section 3.5.3 (Limitation On Third Party Combinations). |
1.189 | “OPDP” means the FDA’s Office of Prescription Drug Promotion (formerly Division of Drug Marketing, Advertising and Communications) or its successor entity. |
1.192 | “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. |
1.194 | “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. |
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1.209 | “Pre-Tax Profit or Loss Schedule” means the schedule set forth in Schedule 8.3.1 attached hereto. |
1.212 | “Product Training Materials” has the meaning set forth in Section 6.10.4 (Product Specific Training). |
1.214 | “Profit-Sharing Territory” means the United States, unless and until the Cost Share End Date occurs. |
1.217 | “Proposed Additional Development” has the meaning set forth in Section 3.4.1 (Additional Development Proposals). |
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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. |
1.226 | “Regulatory Responsible Party” has the meaning set forth in Section 4.1.3 (Regulatory Responsibilities). |
1.228 | “ROW Net Sales Milestones” has the meaning set forth in Section 8.5.1 (ROW Net Sales Milestones). |
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1.229 | “ROW Net Sales Milestone Payments” has the meaning set forth in Section 8.5.1 (ROW Net Sales Milestones). |
1.237 | “Shared Global Development Activities” has the meaning set forth in Section 1.108 (Global Development Plan). |
1.239 | “Subcommittee Deadlock” has the meaning set forth in Section 7.7.1 (Committee Decision Making). |
1.242 | “Target” means T cell immunoreceptor with Ig and immunoreceptor tyrosine-based inhibition motif domains (also known or referred to as TIGIT). |
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1.243 | “Target BLA Filing Date” has the meaning set forth in Section 6.2 (Joint Commercialization Plans). |
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). |
1.254 | “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). |
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2.1 | Effectiveness of the Agreement. This Agreement shall become effective as of the HSR Clearance Date (the “Effective Date”). |
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| (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. |
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| 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). |
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| (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. |
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| 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). |
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| 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). |
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| 3.8.1 | Existing [***]. The Parties each acknowledge where a Licensed Product being Developed under this Agreement is a [***]. |
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| 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. |
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| (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. |
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| (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. |
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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. |
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| 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. |
4.3 | 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 |
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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. |
4.6 | 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 |
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| 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. |
Article 5
Manufacturing and supply
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| 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). |
[***]
| 5.1.3 | 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. |
| 5.1.6 | 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. |
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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. [***]. |
Article 6
COMMERCIALIZATION; MEDICAL AFFAIRS
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6.3 | Commercialization Responsibilities. |
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| 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. |
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6.5 | Limited Disclosure. Nothing in this Agreement shall require GSK to disclose to ITEOS (a) [***] or (b) information pertaining to [***]. |
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| 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). |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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|
| 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). |
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| 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. |
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Article 7
Management of the Collaboration
7.1 | Joint Steering Committee. |
| (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; |
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| (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); |
| (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. |
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7.2 | Joint Development Committee. |
| 7.2.2 | Responsibilities of the JDC. The JDC shall perform the following functions for the Development Program: |
| (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); |
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| (g) | discuss and develop a remediation strategy for material deficiencies regarding animal care and welfare, as described in Section 3.11.6. |
| (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); |
| (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); |
| (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 |
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| (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. |
| (a) | review, discuss and, solely with respect to medical representatives on the JCC, propose modifications to, the Medical Affairs activities set forth in the Joint Commercialization Plan and all updates thereto, as described in Section 6.2 (Joint Commercialization Plan); |
| (b) | review, discuss and recommend modifications to, each Joint Commercialization Plan (including the Joint Commercialization Budget therein), and all updates thereto, and submit such Joint Commercialization Plans and updates to the JSC to review, discuss, and determine whether to approve, as described in Section 6.2 (Joint Commercialization Plan); |
| (c) | review, discuss and comment on the Global Strategic Launch Plan and updates thereto, as described in Section 6.1 (Global Strategic Launch Plan); |
| (e) | review and discuss the details regarding the [***] for each Licensed Product in the major countries of the Net Sales Territory provided by GSK to the JCC in advance, as described in Section 6.3.1 (Net Sales Territory); |
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| (g) | review and discuss each Commercialization Report; |
| (h) | review and discuss each Detailing tracking report, as described in Section 6.10.3 (Sales Representatives); |
| (i) | review and discuss the Compliance Program submitted to the JCC pursuant to Section 6.9.1 (Establishment of Compliance Program); |
| (j) | [***] prior to GSK’s selection thereof, and related materials, as described in Section 6.11 (Product Marks); and |
| (k) | The JCC shall liaise with the Financial Working Group with respect to the calculation of the Pre-Tax Profit or Loss and shall perform such other functions as the Parties may agree in writing are appropriate to further the purposes of this Agreement. |
| 7.3.3 | Term of the JCC. The JCC shall meet in accordance with Section 7.6.2 (Meetings) during the Term prior to the Cost Share End Date. Following the Cost Share End Date, [***]. |
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Financial Working Group shall meet in accordance with Section 7.6.2 (Meetings) for so long as either (i) the Parties are engaging in sharing of Development Costs for the Development Program, or (ii) ITEOS Commercializes the Licensed Products with GSK or its Affiliates in the Profit-Sharing Territory or shares Pre-Tax Profit or Loss with GSK hereunder. |
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| Parties agree to meet by an alternative mechanism (e.g., telephone or videoconference). The JDC, JCC, the Financial Working Group and other Subcommittees, if any, shall each meet at least quarterly after the Subcommittee is formed, or as more or less often as otherwise agreed by the Parties in writing. Committee meetings may be conducted by telephone, videoconference or in person. Any in-person Committee meetings shall be held on an alternating basis between ITEOS’s and GSK’s facilities, unless otherwise agreed by the Parties in writing. Each Party shall be responsible for its own expenses in attending such meetings and those expenses will not be included in Development Costs or Allowable Expenses hereunder. As appropriate, the Committee may invite a reasonable number of non-voting employees, consultants, and scientific advisors to attend its meetings as nonvoting observers, provided that such invitees are bound by appropriate confidentiality obligations substantially similar to the ones set forth in this Agreement. Each Party may also call for special meetings of a Committee to discuss matters requested by such Party. The Alliance Managers shall provide the members of the JSC with no less than [***] notice of each regularly scheduled meeting and, to the extent reasonably practicable under the circumstances, no less than [***] notice of any special meetings of the JSC called by either Party. |
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| (b) | GSK Final Decision Making Authority. GSK will have the right to make the final decision regarding [***]. |
| 7.7.3 | Day-to-Day Decision-Making Authority. Each Party shall have decision making authority with respect to the day-to-day operational and tactical activities of such Party (and such Party’s employees, agents and subcontractors) under this Agreement, provided that such decisions are not inconsistent with the terms and conditions of this Agreement (including any Global Development Plan or |
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| Commercialization Plan) or the decisions and actions of the JSC, the JDC, the JCC, Financial Working Group or any other Subcommittee, as applicable. |
| 7.7.4 | Limitation of Powers. Each Committee will have only the powers as are specifically delegated to it under this Agreement. The JSC is not a substitute for the rights of the Parties under this Agreement and is intended to coordinate and facilitate the activities of the Parties. The JSC will not be involved with the day-to-day management of activities to be performed by a Party under this Agreement. Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Agreement, which shall be made by the Parties only in accordance with Section 17.10 (Entire Agreement). The JSC, the JDC, the JCC, the Financial Working Group, and the Subcommittees will not have the power to: (a) with respect to the calculation or reconciliation of Development Costs and the Pre-Tax Profit or Loss, which for clarity any disagreement by a Committee or by the Parties with respect thereto shall be resolved in accordance with Sections 8.17 (Resolution of Financial Disputes) and 8.18 (Specific Finance Disputes); (b) resolve disputes arising out of the interpretation of this Agreement, which for clarity shall be resolved in accordance with Article 16 (Dispute Resolution); or (c) alter or amend the terms and conditions of this Agreement, or waive compliance with this Agreement. |
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| (a) | Following such notification, the Financial Working Group, in consultation with the JDC (as and if needed), shall discuss the causes of any such |
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| increase and evaluate potential mitigation measures to prevent a further increase of Development Costs. To the extent, based on this discussion, that the Financial Working Group concludes that the anticipated amount of the Development Costs is likely not to exceed [***] of the amounts budgeted for a given Calendar Year (the “Permitted Overage”) as set forth in the then-current applicable Global Development Budget, such anticipated or actual Development Costs shall be included in the calculation of the applicable Development Costs for the purposes of determining the amounts to be paid from one Party to the other Party to reflect the sharing percentages set forth in Section 3.2.3 (Shared Development Costs), provided that such costs are not incurred as a result of any breach of this Agreement by a Party. |
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| Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs required to be reimbursed in accordance with 3.4.3(b) (Proof of Concept Data) or Section 3.4.3(c) (Receipt of Regulatory Approval), as applicable. Within [***] Business Days following the receipt by the Financial Working Group of such written reports setting forth the actual amounts of such reimbursable Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs incurred by a Party, the Financial Working Group shall prepare and submit to each Party a written report setting forth in reasonable detail (i) the calculation of all such reimbursable Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs and any deviations from the budget set forth in the applicable Additional Development Proposal, and (ii) the calculation of the net amount owed by GSK to ITEOS or by ITEOS to GSK in order to ensure the appropriate reimbursement of Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs and the corresponding premium in accordance with Section 3.4.3(b) (Proof of Concept Data) or Section 3.4.3(c) (Receipt of Regulatory Approval), as applicable. The Party that is due for reimbursement shall invoice the other Party within [***] Business Days of receipt of such report from the Financial Working Group. Such payments by one Party to reimburse the other Party’s expenditures for such Additional Development Activities shall be payable on the [***] following receipt of the invoice. Any Out-Of-Pocket Costs, Development FTE Costs, and Manufacturing Costs incurred in excess of [***] the budget set forth in the applicable Additional Development Proposal will be the responsibility of the proposing Party. |
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|
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| 8.3.5 | Reconciliation and Payment. |
| (a) | Reconciliation Discussion. In the event that either Party has any questions or concerns regarding the Development Costs or calculation of Pre-Tax Profit or Loss reported by the other Party in a Financial Report pursuant to Section 8.2.1 (Reports; Reconciliation Payments) and Section 8.3.2 (Reporting Generally), the Financial Working Group shall endeavor to resolve such questions and concerns of either Party within [***] days after the end of each Calendar Quarter. Additionally, the Financial Working Group may by mutual agreement adjust the timing for notification or payment of any reconciliation payments hereunder. |
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| included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Loss hereunder. |
| 8.3.6 | Income Taxes. Subject to Section 8.10 (Tax Matters), income and withholding Taxes imposed on either of the Parties hereunder shall not be included in Pre-Tax Profit or Loss hereunder. |
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| Table 8.4 – Development and Filing Milestones | |||
| Milestone Event | First Indication | Second Indication | Third Indication |
(1) | [***] | [***] | [***] | [***] |
[***] | [***] | [***] | [***] | |
[***] | [***] | [***] | [***] | |
[***] | [***] | [***] | [***] |
For the avoidance of doubt, the total amount of potential milestone payments payable if all milestones are achieved for all three (3) Indications is Five Hundred and Fifty Million Dollars ($550,000,000.00). In the event that a given Licensed Product achieves a Development and Filing Milestone for more than one Indication (e.g., Initiation of a Registration Study of a Licensed Product for two Indications) then all relevant preceding Development and Filing Milestone payments for such Licensed Product shall become due and payable by GSK (e.g., [***]).
If either Party achieves any of the Development and Filing Milestones for a particular Licensed Product in an Indication but without the prior achievement of any corresponding earlier listed Development and Filing Milestone for such Licensed Product in such Indication, then GSK will pay to ITEOS the applicable Development and Filing Milestone Payment to be made with respect to such earlier Development and Filing Milestone for such Licensed Product at the same time as GSK pays the applicable Development and Filing Milestone Payment due upon achievement of such later Development and Filing Milestone. Solely by way of example, if Development and Filing Milestone (1) in Table 8.4 above has not been achieved by a Licensed Product in an Indication at the time Development and Filing Milestone (2) in Table 8.4 above is achieved for a Licensed Product in such Indication, then GSK will pay to ITEOS the Development and Filing Milestone Payment to be made with respect to such Development and Filing Milestone (1) at the same time as GSK pays the Development and Filing Milestone Payment due upon achievement of such Development and Filing Milestone (2).
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| Products within any Calendar Year in the Territory outside of the U.S. meets the corresponding threshold set forth in Table 8.5.1 below (the “ROW Net Sales Milestones”): |
Table 8.5.1 – ROW Net Sales Milestones | |
Milestone Event | Milestone Payment |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the Territory outside of the U.S. are [***] | [***] |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the Territory outside of the U.S. are [***] | [***] |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the Territory outside of the U.S. are [***] | [***] |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the Territory outside of the U.S. are [***] | [***] |
Table 8.5.2 – U.S. Net Sales Milestones | |
Milestone Event | Milestone Payment |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the U.S. are [***] | [***] |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the U.S. are [***] | [***] |
Aggregate Net Sales in a Calendar Year of all Licensed Products in the U.S. are [***] | [***] |
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Table 8.7.1 – Net Sales Royalties | |
Calendar Year Net Sales | Royalty Rate |
For that portion of aggregate Net Sales in a Calendar Year of all Licensed Products in the Net Sales Territory up to and including [***] | [***] |
For that portion of aggregate Net Sales in a Calendar Year of all Licensed Products in the Net Sales Territory greater than [***] up to and including [***] | [***] |
For that portion of aggregate Net Sales in a Calendar Year of all Licensed Products in the Net Sales Territory greater than [***] up to and including [***] | [***] |
For that portion of aggregate Net Sales in a Calendar Year of all Licensed Products in the Net Sales Territory greater than [***] up to and including [***] | [***] |
For that portion of aggregate Net Sales in a Calendar Year of all Licensed Products in the Net Sales Territory greater than [***] | 20% |
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|
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the basis and accuracy of payments made under this Agreement, with respect to any Calendar Year ending not more than [***] years prior to the request of the auditing Party. If the review of such records reveals that the other Party has failed to accurately report financial information required to be reported hereunder, or to make any payment (or portion thereof) required under this Agreement, then the other Party shall pay to the auditing Party any underpaid amounts due hereunder together with interest calculated in the manner provided in Section 8.12 (Late Payments) within [***] days. If any such discrepancies are greater than [***] of the amounts actually due for the audited period, then the other Party shall pay all reasonable costs incurred in conducting such review. Once a Party has conducted a review and audit of the other Party pursuant to this Section 8.8 (Audits) in respect of any given period, it may not subsequently re-inspect the other Party’s records in respect of such period, unless a subsequent audit of a separate reporting period uncovers fraud on the part of the audited Party that is reasonably expected to have been occurring during the prior audited period. For clarity, however, if a discrepancy is identified by the accountant during the course of an audit and the Parties do not agree upon a resolution of such discrepancy, then the auditing Party’s accountant may re-inspect the books and records to the extent reasonably relevant to resolving such discrepancy. Unless otherwise defined or stated, financial terms shall be calculated by the accrual method under the applicable Party’s Accounting Standards. Financial records related to the foregoing shall be maintained (in such form as may be available) by each Party for a period of no less than [***] years following the end of the period to which they pertain. |
8.9 | Accounting Standards. Each Party shall promptly notify the other Party in the event that such Party changes the Accounting Standards pursuant to which such Party’s records are maintained, and it being understood that each Party may only use internationally recognized accounting principles (e.g., IFRS, GAAP). |
| 8.10.1 | Any amount payable by one Party to the other under this Agreement is deemed to be exclusive of any amount in respect of any VAT chargeable on the supply for which that sum is the consideration (in whole or in part) for VAT purposes. If anything done by one Party under this Agreement constitutes, for VAT purposes, the making of a supply to the other Party and VAT is or becomes chargeable on that supply, the Party receiving the supply shall, in any event, receive a valid VAT invoice and shall pay the other Party, in addition to any amount otherwise payable under this Agreement by the Party receiving the supply, a sum equal to the amount of the VAT chargeable on that supply against delivery of a valid VAT invoice to the Party receiving the supply, if applicable. |
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| 8.10.3 | The Parties will cooperate with respect to all documentation required by any taxing authority or reasonably requested by either Party to secure a reduction in the rate of applicable withholding Taxes or an exemption from withholding Taxes. If a Party is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding tax, then it may deliver to the other Party or the appropriate governmental authority the prescribed forms necessary to reduce the applicable rate of withholding or to relieve the Payor of its obligation to withhold tax. If a Payee timely delivers to the Payor a validly executed form establishing a reduced rate or exemption from withholding, the Payor shall apply the reduced rate of withholding, or not withhold, as the case may be, provided that the Payor is in receipt of evidence, in a form reasonably satisfactory to the Payor. If, in accordance with the foregoing, the Payor withholds any amount, then it will pay to the Payee the balance when due, timely remit to the proper taxing authority of the withheld amount, and send the Payee proof of such remittance within [***] days following that remittance. |
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8.11 | Invoicing. To the extent an invoice is required to be submitted to GSK hereunder, such invoice shall include the information set forth in Schedule 8.11. |
8.15 | Disclaimer. ITEOS and GSK each acknowledge and agree that nothing in this Agreement will be construed as representing any estimate or projection of (a) the successful |
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Development or Commercialization of any Licensed Product under this Agreement, (b) if Commercialized, that any Licensed Product will achieve any particular pricing or reimbursement amount or any particular sales level, or (c) anticipated sales or the actual value of any Licensed Product that may be successfully Developed or Commercialized under this Agreement. |
8.16 | Cooperation on Inter-Party Structure. The Parties will reasonably cooperate to establish or facilitate an optimal inter-Party financial operational structure (including, if necessary, procedures and agreements among the various Affiliates of the Parties) which is consistent with the economic result contemplated herein, consistent to the extent feasible with each Party’s internal structures and procedures, and not adverse to the Parties financial, economic, or tax positions. |
Article 9
Licenses; EXCLUSIVITY
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audit rights with respect to its reporting of Net Sales that are consistent with those given by GSK hereunder with respect to its sales included in Net Sales. |
9.5 | Requirements of Sublicensees and Subcontractors. GSK’s use of Affiliates, Sublicensees or subcontractors shall not relieve GSK of any obligation hereunder and GSK shall cause its Affiliates, Sublicensees or subcontractors to comply with its applicable obligations under this Agreement. GSK shall remain responsible under this Agreement for ensuring the compliance of Affiliates, Sublicensees and subcontractors with this Agreement. |
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country or jurisdiction, including the right to obtain such intellectual property from another entity. In the event of the commencement of a bankruptcy proceeding by or against a Party under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, the non-bankrupt Party shall be entitled to a complete duplicate of (or complete access to, as appropriate) all such intellectual property (including all embodiments of such intellectual property), which, if not already in the non-bankrupt Party’s possession, shall be promptly delivered to it upon its’s written request (a) upon commencement of a bankruptcy proceeding, unless the bankrupt Party continues to perform all of its obligations under this Agreement, or (b) if not delivered pursuant to clause (a) because the bankrupt continues to perform, upon the rejection of this Agreement by or on behalf of the bankrupt Party. Unless and until the bankrupt Party rejects this Agreement, the bankrupt Party shall perform this Agreement or provide such intellectual property (including all embodiments of such intellectual property) to the non-bankrupt Party, and shall not interfere with the rights of the non-bankrupt Party to such intellectual property, including the right to obtain the intellectual property from another entity. In the case of an insolvency that is governed by non-U.S. bankruptcy law, the Parties agree that, to the extent not prohibited by the applicable insolvency law, the non-bankrupt Party will be entitled to at least the same rights and protections afforded by the U.S. Bankruptcy Code, including survival of the licenses granted hereunder even if the bankrupt Party revokes or terminates this Agreement and a copy of the embodiments of such intellectual property, without conditions other than any legally required payment of royalties. Further, each Party agrees and acknowledges that all payments by GSK to ITEOS hereunder, including under Section 8.4 (Development and Filing Milestones), Section 8.5 (Net Sales Milestones), and Section 9.7 (Royalties and Payments), constitute royalties within the meaning of Section 365(n) of the Bankruptcy Code and relate to licenses of intellectual property hereunder. |
9.8 | Technology Transfer. Promptly following the Effective Date, ITEOS shall transfer and deliver to GSK (in order to enable GSK to practice under the licenses granted to GSK under Section 9.1 (License Grant to GSK)), Know-How within the ITEOS Technology (including Materials) to enable GSK to Develop, Manufacture and Commercialize Licensed Antibodies and Licensed Products as contemplated under this Agreement. |
9.9 | Existing Third Party Agreements. All licenses granted by a Party to the other Party in this Article 9 (Licenses; Exclusivity) shall be subject to the licensing restrictions set forth in the Third Party agreements between such Party and any Third Party existing as of the Execution Date. Without limiting the foregoing, the licenses granted by ITEOS to GSK under 9.1 (License Grant to GSK) shall be subject to the ITEOS Background Agreements, for so long as such ITEOS Background Agreements are in effect. [***]. |
9.10 | [***] |
| 9.11.1 | Identified Third Party IP. [***] (“Third Party IP”) [***]. |
| 9.11.2 | Potential In-Licenses. Prior to executing an agreement with a Third Party to acquire or license any Third Party IP (any such agreement, a “Potential In- |
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| such Party to violate the exclusivity obligations set forth in Section 9.12.1 (Mutual Exclusivity Covenant) (such activities, a “Competing Program”), then: |
Article 10
CONFIDENTIALITY; Publications and Presentations
| 10.2.1 | is or becomes part of the public domain through no wrongful act, fault or negligence on the part of the Receiving Party; |
| 10.2.2 | was in the Receiving Party’s possession prior to initial disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information; |
| 10.2.3 | is subsequently received by the Receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information; |
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| 10.2.4 | has been published by a Third Party or otherwise enters the public domain through no fault of the Receiving Party in breach of its contractual obligations to the Disclosing Party; or |
| 10.2.5 | was independently developed (outside the scope of this Agreement) by or for the Receiving Party without reference to or use of the Disclosing Party’s Confidential Information. |
10.3 | Authorized Disclosure. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such disclosure is: |
| (a) | made in response to a valid order of a court or other governmental authority or, if in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law, including by reason of filing with securities regulators; provided that the Receiving Party shall, where practicable, first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order; |
| (b) | made by or on behalf of the Receiving Party to Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval for the Licensed Products as permitted by this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with Applicable Law; |
| (c) | made by or on behalf of the Receiving Party to a patent authority as may be reasonably necessary for purposes of obtaining a Patent as permitted by this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or |
| (d) | made by the Receiving Party to its attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, licensees, sublicensees, existing or prospective investors, prospective acquirers, prospective lenders, prospective financing sources (including, in each case, in connection with any royalty factoring transaction) or other Third Parties as may be necessary in connection with the performance of or exercise of rights under this Agreement or as required under the terms of agreements with Third Parties (including such agreements with Third Parties relating to Other Components included in Combination Products), in each case, for the limited purpose of such collaboration, license, sublicense, financing or acquisition activities; provided that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential |
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| Information substantially similar to the obligations of confidentiality and non-use of the Receiving Party set forth herein. |
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Presentations) without the advance written consent of the other Party, so long as (i) such subsequent public announcements or press releases are released without changes to the substantive information provided therein, (ii) are released within [***] months of the original release, and (iii) the information provided therein is still considered accurate and has not been superseded by other subsequent information known by such Party. |
10.7 | Use of Name. Notwithstanding any provision to the contrary set forth in this Agreement, neither Party will use the other’s name or logo in any press release or product advertising, or for any other promotional purpose, without first obtaining the other's written consent and entering into appropriate trademark or housemark licenses, as applicable. |
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| abstracts) prior to any submission or disclosure to any Third Party to allow the other Party to review such proposed publication or presentation. The reviewing Party shall provide the publishing Party with its comments, if any, in writing within [***] days [***] days in the case of abstracts) after receipt of such proposed publication. The publishing Party shall consider in good faith any comments thereto provided by the reviewing Party and shall comply with the reviewing Party’s request to remove any and all of the reviewing Party’s Confidential Information from the proposed publication. In addition, upon the reviewing Party’s reasonable request, the publishing Party shall delay the submission for a period up to [***] days to permit the preparation and filing of a patent application. Upon expiration of such [***] days, the publishing Party will be free to proceed with the publication or presentation. If the reviewing Party fails to provide its comments to the publishing Party within such [***] day-period [***] day-period in the case of abstracts), the reviewing Party shall be deemed to not have any comments. |
| 10.8.3 | Authorship; Acknowledgement. Each Party will ascribe authorship of any proposed publication using accepted standards used in peer-reviewed, academic journals at the time of the proposed publication. Any publication or disclosure made by either Party pursuant to this Section 10.8 (Scientific Publications) shall contain appropriate acknowledgements of the contribution of the other Party or any Third Party to the Development activities that are the subject of such publication, in accordance with generally accepted academic practice. |
| 10.8.5 | Publications Permitted. Each publication made in accordance with this Section 10.8 (Scientific Publications) shall not be a breach of the confidentiality provisions contained in Section 10.2 (Confidentiality). |
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Article 11
INTELLECTUAL PROPERTY
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|
| 11.1.6 | Assignment Obligation. Each Party shall cause all employees, independent contractors, consultants and others who perform activities for such Party or its Affiliates under this Agreement to be under an obligation to assign (or, if such Party is unable to cause such person or entity to agree to such assignment obligation |
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| despite such Party using reasonable efforts to negotiate such assignment obligation, provide an exclusive, perpetual, irrevocable, worldwide license under) their rights in and to any Know-How and all intellectual property rights therein to such Party (or to an entity that is obligated to assign such rights to such Party), except where Applicable Law requires otherwise and except in the case of governmental, not-for-profit and public institutions that have standard policies against such an assignment (in which case a Party shall obtain a suitable license, or right to obtain such a license). Further, each Party acknowledges and agrees that it will not intentionally take any action or make any statement that contradicts or negates any such assignment of Know-How or intellectual property rights by its employees, independent contractors, consultants or others who perform activities for such Party under this Agreement. |
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|
| 11.2.2 | Subject Patent Costs. Subject to Section 6.7.3 (Effects of Opt-Out), the Parties shall share all Patent Costs in the U.S. and the European Union as Development Costs with respect to Subject Patents during the Term until the Regulatory Approval of the first Licensed Product. Following Regulatory Approval of the first Licensed Product, GSK shall pay all such Patent Costs in the Net Sales Territory and, subject to Section 6.7.3 (Effects of Opt-Out), the Parties shall share such Patent Costs with respect to Profit-Sharing Territory as set forth in the Pre-Tax Profit or Loss Schedule. |
| 11.2.4 | Cooperation. The Party that is not the Controlling Party will cooperate with the other Party, including furnishing a power of attorney, inventor declaration or assignment documentation, to allow such preparation, prosecution, maintenance or defense activities to be carried out effectively and expeditiously. |
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| Party decides not to abate such Infringement by way of enforcing one or more applicable Subject Patents against the relevant Third Parties, then the Controlling Party shall inform the other Party of such decision in writing no later than [***] days after such Controlling Party first becomes aware of such Infringement. Upon receiving such notice from the Controlling Party, or if no such action to abate such Infringement is taken by the Controlling Party within such [***] day time period, the other Party shall thereafter immediately become deemed the Controlling Party for the purposes of this Section 11.3.2 (Enforcement and Recoveries). The Controlling Party will keep the other Party reasonably informed through the Patent Liaisons on a regular basis regarding, and provide such other Party with reasonable opportunity to consult and comment on, all enforcement activities and materials in respect of the Subject Patents. The non-Controlling Party shall have the right, to the extent permitted by Applicable Laws and procedural rules to join, using its own counsel, as a party to the enforcement actions included in such enforcement activities. |
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| to otherwise maintain or pursue such enforcement action effectively and expeditiously. |
| 11.3.5 | Settlement with a Third Party. The Controlling Party that is controlling an enforcement action shall also have the right to control the settlement of such enforcement action; provided that the Controlling Party shall not admit the unenforceability or invalidity of Patents Controlled by the other Party or its Affiliates, or of Patents within the Joint Arising Technology, or that otherwise materially adversely affects the other Party’s interest in the ITEOS Technology or the Joint Arising Technology, in all cases, without such other Party’s prior written consent. |
11.4 | Infringement Claims by Third Parties. |
| 11.4.2 | Cooperation; Settlement. Each Party shall keep the other Party reasonably informed of all material developments in connection with any Third Party Infringement Claim through the Patent Liaisons. Such Party shall provide the other Party with copies of all filings by or correspondence from the counterparty(ies) in any suit or proceeding relating to such Third Party Infringement Claim, and with copies of proposed filings to be filed or material correspondence to be delivered to such counterparty(ies) by the Party defending such Third Party Infringement Claim in such proceedings at least [***] days prior to the anticipated filing or delivery date thereof for the other Party to comment on, and the Party defending such Third Party Infringement Claim shall take all such comments received under good faith consideration. The Party defending such Third Party Infringement Claim may enter into a settlement or compromise of any Third Party Infringement Claim, provided that, if such settlement or compromise would admit liability on the part of the other Party or any of its Affiliates or would otherwise have a material adverse effect on the rights or interests of the other Party or its Affiliates (including by imposing any monetary obligation upon the other Party or its Affiliates or by limiting the scope of or admitting the unenforceability or invalidity of Patents owned or exclusively licensed by the other Party or its Affiliates), then such Party shall not enter into such settlement or compromise without the prior written consent of the other Party. Any counterclaims of Infringement shall be handled as set forth in Section 11.3 (Enforcement Rights). |
| 11.4.3 | Costs; Recoveries. All out-of-pocket expenses incurred by a Party in defending a Third Party Infringement Claim (including outside counsel fees) and all amounts payable by either Party as a judgment based on a Third Party Infringement Claim |
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| or in settlement of such Third Party Infringement Claim, shall be allocated as follows: (a) with respect to Third Party Infringement Claims directed to the activities conducted hereunder for the Licensed Products in the Profit-Sharing Territory prior to the Cost Share End Date, then such out-of-pocket expenses will [***], and (b) with respect to Third Party Infringement Claims directed to the activities conducted hereunder for the Licensed Products in the Net Sales Territory, then [***]. |
Article 12
Term and Termination
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12.4 | [***] |
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as the dispute is resolved pursuant to Article 16 (Dispute Resolution). Notwithstanding the foregoing, the [***] is the result of [***]. |
Table 12.6 – Development Deadlines | |
Development Milestone Event | Deadline for Achievement |
[***] | [***]
|
[***] | [***]
|
[***] | [***] |
Article 13
Effects of Expiration or Termination
| 13.2.1 | General Effects of Termination. Upon termination of this Agreement in its entirety pursuant to Article 12 (Term and Termination), the Parties’ rights and obligations under this Agreement will terminate and neither Party will have any |
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| further rights or obligations under this Agreement from and after the effective date of termination, except as set forth in this Section 13.2 (Effects of Termination) or Section 13.3 (Survival). Upon termination of this Agreement with respect to one or more terminated Licensed Products, neither Party will have any further rights or obligations under this Agreement with respect to such terminated Licensed Products from and after the effective date of termination for such terminated Licensed Product, except as set forth in this Section 13.2 (Effects of Termination) or Section 13.3 (Survival). |
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| after the date of the Disclosing Party’s request after termination or expiration of this Agreement, as applicable. Notwithstanding the return or destruction of the documents and tangible items described above, the Parties will continue to be bound by their obligations under Article 10 (Confidentiality; Publications and Presentations). |
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| Regulatory Approvals, Data and other material documentation, to the extent allowed under Applicable Laws, solely for such terminated Licensed Products for the continued Development and Commercialization thereof by ITEOS. Further, ITEOS will grant back to GSK a non-exclusive right of reference to such Regulatory Filings in order for GSK to continue Develop and Commercialize products owned or controlled by GSK or its Affiliates that incorporate an Other Component in a Co-Administration Therapy with such terminated Licensed Products. |
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| IP) would give rise to any license fee or any other financial obligation or liability owed to any Third Party, then (i) GSK will notify ITEOS of such financial obligations, (ii) ITEOS will confirm in writing whether ITEOS would like the license granted to ITEOS under this Section 13.2.8 (License of Certain IP) to include the rights giving rise to such financial obligations, and (iii) (A) if ITEOS confirms that it would like the license granted to ITEOS under this Section 13.2.8 (License of Certain IP) to include such rights, then ITEOS shall be solely responsible for and shall timely pay, and shall hold GSK harmless with respect to, any and all such license fees and financial obligations and liabilities, or (B) if ITEOS confirms that it would like the license granted to ITEOS under this Section 13.2.8 (License of Certain IP) not to include such rights, then the license granted under this Section 13.2.8 (License of Certain IP) will not include such rights and ITEOS will not be responsible for such license fees or other financial obligations. |
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of time provided for in Section 10.2 (Confidentiality)), Section 11.1 (Ownership of Intellectual Property), Section 8.7.7 (Expiration of Royalty Term), and Section 14.4 (Disclaimer of Warranty) and Article 1 (Definitions), Article 13 (Effects of Expiration or Termination), Article 15 (Indemnification), Article 16 (Dispute Resolution), and Article 17 (Miscellaneous). |
Representations and Warranties AND Covenants
14.1 | Mutual Representations, Warranties and Covenants. Each Party represents and warrants to the other Party as of the Execution Date, and covenants (as applicable) that: |
| 14.1.1 | such Party is duly organized, validly existing and in good standing under the Applicable Laws of the jurisdiction of its incorporation and has full corporate power and authority and legal right to enter into this Agreement and to carry out the provisions hereof; |
| 14.1.2 | such Party has the right to grant the licenses to the other Party purported to be granted pursuant to this Agreement; |
| 14.1.3 | such Party has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder, and this Agreement constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with the terms and conditions hereof; |
| 14.1.4 | such Party has received all necessary licenses and certificates with respect to facilities within such Party’s ownership or control sufficient to allow such Party to conduct the activities assigned to such Party under the Global Development Plan, and such Party is in compliance with the requirements of such licenses and certificates; |
| 14.1.5 | entering into this Agreement by such Party (a) will not constitute a default under, or conflict with, any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, (b) violate any Applicable Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and (c) is not prohibited or limited by, and shall not result in the breach of or a default under, any provision of the certificate or articles of incorporation or bylaws of such Party; |
| 14.1.6 | except for any HSR Filings that may be required to comply with the HSR Act, it is not and will not be required to give any notice to any governmental authority or obtain any approval in connection with the execution and delivery of this Agreement; |
| 14.1.7 | such Party and its Affiliates have not employed and during the Term, will not employ any Person debarred by the FDA (or subject to a similar sanction of EMA |
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| or foreign equivalent), or any Person who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent); |
| 14.1.8 | such Party and its Affiliates performing activities under this Agreement has in place or will have in place prior to its conduct of its activities under the Agreement a written agreement with its employees and other personnel it appoints to perform such activities hereunder to ensure that such Party has sufficient ownership or license rights to any Arising Technology invented, discovered, created or developed by such Party to grant the rights to the other Party as required to be granted under this Agreement; |
| 14.1.9 | as relevant to this Agreement: (a) such Party did not employ child labor, forced labor, or cruel or abusive disciplinary practices in the workplace; (b) such Party did not discriminate against any workers on any ground in violation of Applicable Law (including race, religion, disability, gender, sexual orientation or gender identity); and (c) such Party paid each employee at least the minimum wage, provided each employee with all legally mandated benefits, and complies with all Applicable Laws on working hours and employment rights in the countries in which it operates; |
| 14.1.11 | such Party shall, and shall cause its Affiliates and its and their respective subcontractors and Sublicensees to, conduct all activities undertaken pursuant to this Agreement in accordance with Applicable Law, including entering into any data protection agreements required under Data Protection Laws. |
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|
| 14.2.2 | ITEOS has not entered into any agreement, and shall not enter into any agreement, granting any right, interest or claim in or to, any Licensed Antibodies or Licensed Products or the ITEOS Technology, in each case, that would conflict or contravene with the rights and licenses granted to GSK in this Agreement and has not granted, and will not grant, any right to any Third Party that would conflict or contravene with the rights granted to GSK hereunder; |
| 14.2.3 | all ITEOS Background Patents included in the ITEOS Technology are existing and, to ITEOS’s Knowledge, are not invalid or unenforceable; |
| 14.2.4 | to ITEOS’s Knowledge no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate any ITEOS Background Patents or ITEOS Background Know-How, in each case, included in the ITEOS Technology; |
| 14.2.5 | no claim or litigation has been brought or threatened in writing by any Person against ITEOS alleging that (a) any ITEOS Background Patents included in the ITEOS Technology are invalid or unenforceable, or (b) except to the extent otherwise disclosed by ITEOS to GSK prior to such date, the use or practice of any ITEOS Background Patents or ITEOS Background Know-How, or the disclosing, copying, making, assigning or licensing of any ITEOS Background Patents or ITEOS Background Know-How, in each case, included in the ITEOS Technology; |
| 14.2.6 | to ITEOS’s Knowledge, there are not any scientific or technical facts or circumstances that have not been disclosed by ITEOS to GSK, and that would, in ITEOS’s reasonable estimation, have a material adverse effect on the scientific, therapeutic or commercial potential of Licensed Antibodies and Licensed Product; |
| 14.2.7 | all information and data provided by or on behalf of ITEOS to GSK on or before the Effective Date in contemplation of this Agreement was and is true and accurate in all material respects at the time of disclosure thereof; |
| 14.2.8 | to ITEOS’s Knowledge, the conception and reduction to practice of any inventions and the use or development of any other information within the ITEOS Background Know-How owned by ITEOS have not constituted or involved the misappropriation of trade secrets of any Third Party; |
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| 14.2.10 | ITEOS has provided complete and accurate copies to GSK of ITEOS Background Agreements (which may be redacted as necessary to comply with obligations to such Third Party) and to ITEOS’s Knowledge, that are not any material breaches of any ITEOS Background Agreement that would give any Third Party the right to terminate the same. |
| 14.3.2 | [***]; and |
| 14.3.3 | [***]. |
| 15.1.1 | Indemnification by ITEOS. ITEOS hereby agrees to indemnify, defend and hold harmless GSK and its Affiliates and their respective directors, officers, employees |
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| and agents, and the respective successors and assigns any of the foregoing (“GSK Indemnitees”), from and against any and all suits, claims, actions, demands, losses, damages, liabilities, settlements, penalties, fines, costs and expenses (including reasonable attorneys’ fees and other expenses of litigation) (collectively, “Losses”) asserted by a Third Party to the extent arising from (a) any inaccuracy as of the date when made of any of ITEOS’s representations and warranties hereunder, (b) an ITEOS Indemnitee’s breach of this Agreement, gross negligence or willful misconduct, or (c) the Development and Commercialization by or on behalf of ITEOS or its Affiliates pursuant to this Agreement, except to the extent such Losses arise out of (i) Product Claims relating to or asserted in the Profit-Sharing Territory, other than to the extent attributable to gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees or Third Party contractors, or (ii) the conduct described in Section 15.1.2(a)-(d) (Indemnification by GSK) below. |
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| (Indemnification) shall not apply to amounts paid by an Indemnitee in settlement of any action with respect to a Third Party claim, if such settlement is effected without the prior written consent of the Indemnifying Party, which consent shall not be withheld unreasonably. In no event shall the Indemnifying Party settle or abate any Third Party claim in a manner that would diminish the rights or interests of the Indemnitee, admit any liability on the part of the Indemnitee, or obligate the Indemnitee to make any payment, take any action, or refrain from taking any action, without the prior written approval of the Indemnitee. |
15.2 | Insurance. |
| 15.2.1 | ITEOS’s Insurance Obligations. ITEOS shall maintain, at its cost, reasonable insurance against liability and other risks associated with its activities contemplated by this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are determined to be advisable by ITEOS, based on advice from insurance professionals, for companies of similar size and with similar resources for the activities to be conducted by it under this Agreement taking into account the scope of the activities for which ITEOS is responsible hereunder. ITEOS shall furnish to GSK evidence of such insurance, upon request. |
| 15.2.2 | GSK’s Insurance Obligations. GSK shall maintain, at its cost, insurance or self-insurance with respect to liabilities and other risks associated with its activities and obligations under this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are customary for prudent practices for large companies in the pharmaceutical industry for the activities to be conducted by GSK under this Agreement. GSK shall furnish to ITEOS evidence of such insurance or self-insurance, upon reasonable request. |
15.3 | LIMITATION OF CONSEQUENTIAL DAMAGES. EXCEPT FOR A PARTY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 15.1 (INDEMNIFICATION), A BREACH OF A PARTY’S OBLIGATIONS UNDER SECTION 9.12 (EXCLUSIVITY) OR A BREACH OF A PARTY’S CONFIDENTIALITY OBLIGATIONS IN Article 10 (CONFIDENTIALITY; PUBLICATIONS AND PRESENTATIONS), NEITHER ITEOS NOR GSK, NOR ANY OF THEIR AFFILIATES OR SUBLICENSEES WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT, ITS AFFILIATES OR ANY OF THEIR SUBLICENSEES, FOR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR OTHER INDIRECT DAMAGES, INCLUDING LOST PROFITS, LOST DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY) OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. |
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| 16.2.1 | Any disputes concerning the propriety of the commencement of the arbitration or the scope or applicability of this agreement to arbitrate shall be finally settled by the arbitrator(s). |
| 16.2.2 | There shall be one or more arbitrators appointed in accordance with the AAA Rules. |
| 16.2.3 | The governing law in Section 17.1 (Governing Law) shall govern such proceedings. The place of arbitration shall be New York, New York, unless otherwise agreed to by the Parties, and the language of the arbitration shall be English. |
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| a court in accordance with Sections 16.2.5 (Award), 16.2.7 (Injunctive Relief) and 16.2.10 (Patent Disputes). |
| 16.2.6 | Costs. The arbitrator(s) shall award to the prevailing Party, if any, as determined by the arbitrator(s), the prevailing Party’s cost, fees and expenses incurred in connection with such arbitration. |
| 16.2.8 | Confidentiality. The arbitration proceeding shall be confidential and the arbitrator(s) shall issue appropriate protective orders to safeguard each Party’s Confidential Information. Except as required by Applicable Law, no Party shall make (or instruct the arbitrator(s) to make) any public announcement with respect to the proceedings or decision of the arbitrator(s) without prior written consent of the other Party. The existence of any Dispute submitted to arbitration, and any award shall be kept in confidence by the Parties and the arbitrator(s), except as required in connection with the enforcement of such award or as otherwise required by Applicable Law. Notwithstanding the foregoing, each Party shall have the right to disclose information regarding the arbitration proceeding to the same extent as it may disclose Confidential Information of the other Party under Article 10 (Confidentiality; Publications and Presentations) above. |
| 16.2.9 | Survivability. Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason. |
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| a court of competent jurisdiction or patent office in the country in which such intellectual property rights were granted or arose. |
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If to GSK:
GlaxoSmithKline
259 E Grand Ave Fifth Floor, Suite 1
San Francisco, CA 94080
Attn.: SVP & Head R&D Business Development
With a copy (which shall not constitute notice to):
GlaxoSmithKline
980 Great West Road
Brentford, Middlesex TW8 9GS
United Kingdom
Attn.: VP & Head of Legal Business Development & Corporate
If to ITEOS:
iTeos Therapeutics
139 Main Street
Cambridge, MA 02142
Attn.: Chief Operating Officer
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With a copy (which shall not constitute notice to):
Ropes & Gray LLP
800 Boylston St.; Prudential Tower
Boston, MA 02199
Attn.: Hannah H. Freeman
17.6 | Export Clause. Each Party acknowledges that the Applicable Laws of the United States and other Applicable Laws restrict the export and re-export of certain commodities and technical data. Each Party agrees that it will not export or re-export restricted commodities or technical data of the other Party in any form without the appropriate United States or foreign government licenses. |
17.8 | Severability. If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, then the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of any other provision of this Agreement or of such provision in any other jurisdiction, unless the invalid, illegal or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without such invalid provisions. |
17.9 | Performance by Affiliates. Either Party may exercise its rights and perform its obligations under this Agreement directly or through one or more of its Affiliates. Each Party’s Affiliates will have the benefit of all rights (including all licenses) of such Party under this Agreement. Accordingly, in this Agreement “ITEOS” will be interpreted to mean “ITEOS or its Affiliates” and “GSK” will be interpreted to mean “GSK or its Affiliates” where necessary to give each Party’s Affiliates the benefit of the rights provided to the applicable Party in this Agreement; provided, however, that in any event each Party will remain responsible hereunder for the acts and omissions of its respective Affiliates. |
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subject matter hereof, including the CDA, and all information exchanged between the Parties under the CDA shall be considered Confidential Information exchanged hereunder upon the Effective Date. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of both Parties. |
17.13 | Headings. Headings used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement. |
17.14 | Further Actions. Each Party shall execute, acknowledge and deliver such further instruments, and do all such other acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement. |
17.15 | Supremacy. To the extent of any express conflict or inconsistency between this Agreement and any Schedule hereto, the terms and conditions of this Agreement shall control. |
17.17 | Binding Effect; No Third Party Beneficiaries. As of the Effective Date, this Agreement will be binding upon and inure to the benefit of the Parties and their respective permitted successors and assigns. This Agreement is intended for the benefit of the Parties, their respective permitted successors and assigns, and is not for the benefit of, nor many any provision hereof be enforced by, any other Person other than with respect to the indemnification provisions in Article 15 (Indemnification) and as otherwise expressly set forth herein. |
17.18 | Interpretation. The definitions of the terms herein will apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun will include the corresponding masculine, feminine, and neuter forms. The word “any” will |
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mean “any and all” unless otherwise clearly indicated by context. Unless the context requires otherwise, (a) any definition of or reference to any agreement, instrument, or other document herein will be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein), (b) any reference to any Applicable Laws herein will be construed as referring to such Applicable Laws as from time to time enacted, repealed, or amended, (c) any reference herein to any Person will be construed to mean the Person’s successors and assigns (after any such succession or assignment), (d) the words “herein”, “hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (e) the word “or” will be interpreted to mean “and/or”, (f) all references herein to Articles, Sections, or Exhibits, unless otherwise specifically provided, will be construed to refer to Articles, Sections, and Exhibits of this Agreement, (g) the words “include” and “including” will be interpreted to mean “include without limitation” and “including without limitation,” respectively, (h) wherever used, the word “shall” and the word “will” are each understood to be imperative or mandatory in nature and are interchangeable with one another, (i) the word “notice” means notice in writing (whether or not specifically stated) and will include notices, consents, approvals and other written communications contemplated under this Agreement, and (j) provisions that require that a Party, the Parties or any committee hereunder “agree,” “consent,” or “approve” or the like will require that such agreement, consent or approval be specific and in writing, whether by written agreement, letter, approved minutes, or otherwise (but excluding e‑mail and instant messaging). |
[Signature page follows]
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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Execution Date by their respective duly authorized representatives as set forth below.
GLAXOSMITHKLINE INTELLECTUAL | ||
PROPERTY (NO. 4) LIMITED | ||
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/s/ John Sadler | ||
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By: |
| John Sadler |
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Its: |
| Corporate Director |
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ITEOS belgium s.a. | ||
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/s/ Michel Detheux | ||
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By: |
| Michel Detheux |
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Its: |
| Board Member |
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/s/ Gregory Driessens | ||
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By: |
| Gregory Driessens |
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| Board Member |
[***]