COLLABORATION AND LICENSE AGREEMENT BY AND BETWEEN, on the one hand, XENCOR, INC., AND, on the other hand, GENENTECH, INC. AND AS OF FEBRUARY 4, 2019
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT,
MARKED BY [***], HAS BEEN OMITTED BECAUSE MIRATI THERAPEUTICS, INC.
HAS DETERMINED THE INFORMATION (I) IS NOT MATERIAL AND
(II) WOULD LIKELY CAUSE COMPETITIVE HARM TO
XENCOR, INC. IF PUBLICLY DISCLOSED.
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Exhibit 10.1
COLLABORATION AND LICENSE AGREEMENT
BY AND BETWEEN,
on the one hand,
XENCOR, INC.,
AND,
on the other hand,
GENENTECH, INC.
AND
X. Xxxxxxxx-Xx Xxxxx Ltd,
AS OF FEBRUARY 4, 2019
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TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS.............................................................................................................2
ARTICLE 2 GOVERNANCE.........................................................................................................26
ARTICLE 3 RESEARCH.............................................................................................................32
ARTICLE 4 DEVELOPMENT.......................................................................................................34
ARTICLE 5 REGULATORY.........................................................................................................42
ARTICLE 6 COMMERCIALIZATION AND MEDICAL AFFAIRS.......................................................45
ARTICLE 7 MANUFACTURING; MATERIAL TRANSFER...............................................................49
ARTICLE 8 FINANCIAL TERMS...................................................................................................53
ARTICLE 9 LICENSES...............................................................................................................61
ARTICLE 10 INTELLECTUAL PROPERTY; OWNERSHIP...............................................................66
ARTICLE 11 CONFIDENTIALITY.................................................................................................74
ARTICLE 12 PUBLICITY; PUBLICATIONS; USE OF NAME.............................................................76
ARTICLE 13 REPRESENTATIONS...............................................................................................78
ARTICLE 14 INDEMNIFICATION; LIABILITY; INSURANCE...........................................................81
ARTICLE 15 TERM; TERMINATION.............................................................................................84
ARTICLE 16 DISPUTE RESOLUTION.........................................................................................92
ARTICLE 17 MISCELLANEOUS...................................................................................................95
Exhibit A...............................................................................................................................102
Exhibit B...............................................................................................................................104
Exhibit C...............................................................................................................................106
Exhibit D...............................................................................................................................109
Exhibit E...............................................................................................................................110
Exhibit F.................................................................................................................................113
Exhibit G...............................................................................................................................115
Exhibit H...............................................................................................................................116
Exhibit I...................................................................................................................................117
Exhibit J.................................................................................................................................119
Exhibit K.................................................................................................................................120
Exhibit L.................................................................................................................................123
Exhibit M...............................................................................................................................124
Exhibit N...............................................................................................................................132
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COLLABORATION AND LICENSE AGREEMENT
This Collaboration and License Agreement (“Agreement”) is made as of February 4, 2019 (“Execution Date”), by and between, on the one hand, Xencor, Inc., a Delaware corporation, having its principal place of business at 000 Xxxx Xxxxx Xxxxxx, Xxxxxxxx, Xxxxxxxxxx, 00000 (“Xencor”), and, on the other hand, Genentech, Inc., a Delaware corporation, having its principal place of business at 0 XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000 (“GNE”), and X. Xxxxxxxx-Xx Xxxxx Ltd, a corporation organized and existing under the laws of Switzerland, having its principal place of business at Xxxxxxxxxxxxxxxxx 000, XX 0000 Xxxxx, Xxxxxxxxxxx (“Roche”) (GNE and Roche, collectively, “Genentech”). Xencor and Genentech are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
WHEREAS, Xencor is a biotechnology company that is engaged in research and development of pharmaceutical products.
WHEREAS, Genentech is a biopharmaceutical company that is engaged in the research, development, manufacture and sale of pharmaceutical products.
WHEREAS, Genentech and Xencor wish to conduct research and development activities on the terms set forth herein to enable the commercialization of Collaboration Products and, in accordance with the terms herein, wish to share the profits and losses associated therewith as set forth herein.
WHEREAS, Genentech desires to obtain an exclusive license and other rights from Xencor to research Collaboration Constructs and develop and commercialize Collaboration Products, and Xencor agrees to grant Genentech such an exclusive license and other rights in accordance with the terms and conditions set forth below.
NOW THEREFORE, in consideration of the foregoing premises and the mutual covenants contained herein, the receipt and sufficiency of which are hereby acknowledged, Genentech and Xencor hereby 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.
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1.2 “Act” is defined in Section 7.5. |
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1.5 “Allowable Expenses” means, with respect to a Collaboration Product, subject to this Agreement (including Sections 8.4.1, 8.4.2, and 8.6), the following FTE Costs incurred, and any direct out-of-pocket costs or expenses paid or accrued in accordance with the applicable Accounting Standard(s), by or on behalf of a Party or any of its Affiliates during the Term that are specifically identifiable or reasonably allocable to the Commercialization of such Collaboration Product, or the Manufacture of such Collaboration Product in support of such Commercialization: |
(i)Fixed SG&A;
(ii)Cost of Manufacture (except for Costs of Manufacture of Collaboration Products subject to subclauses (i)- (iv), inclusive, in Section 1.167(b));
(iii)costs or expenses for Medical Affairs Activities incurred or accrued after the First Commercial Sale of such Collaboration Product in the Territory;
(iv) Patent costs following the First Commercial Sale of such Collaboration Product in the Territory (to the extent not otherwise reimbursed, including through recoveries obtained in connection with any litigation, as contemplated under Sections 10.4 and 10.9);
(v)costs or expenses incurred or accrued for Product Trademarks of such Collaboration Product following the First Commercial Sale of such Collaboration Product in the Territory;
(vi)Third Party IP Payments;
(vii)costs or expenses associated with recall or withdrawal of such Collaboration Product, other than those as to which a Party has an obligation of indemnification under ARTICLE 14;
(viii)Losses specifically identifiable or reasonably allocable to the Commercialization of such Collaboration Product, or the Manufacture of such Collaboration Product in support of such Commercialization, other than those as to which a Party has an obligation of indemnification under ARTICLE 14;
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(ix)any other costs or expenses of Genentech, its Affiliates, and its sublicensees specifically identifiable or reasonably allocable to the Commercialization of such Collaboration Product as consistently applied across its portfolio.
Allowable Expenses do not include any Development Costs or Launch Costs.
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1.7 “Arbitrator” is defined in Section 8.11. |
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1.8 “Authorized CDMO” is defined in Section 15.4. |
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1.9 “Business Day” means a day, other than a Saturday, Sunday or day on which commercial banks located in California, United States are authorized or required by Applicable Law to close. |
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1.12 “Cessation Notice” is defined in Section 15.2.4(a). |
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1.13 “CGL” is defined in Section 14.7.1(a). |
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1.15 “Change in Control Notice” is defined in Section 17.15. |
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1.16 “Claims” is defined in Section 14.1. |
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1.17 “Class of Agents” means (i) all pharmaceutical products that intentionally and specifically bind the same Target, or all of the same Targets if such product intentionally and specifically binds |
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multiple Targets, as a (a) Targeted Collaboration Construct that is Researched or Developed under a Research Plan or the GDP or (b) Combination Agent, and (ii) [***] (collectively and as a class unto themselves) as a Combination Agent. [***]. |
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1.18 “Clinical Data” means, with respect to any Collaboration Product and any other drug included in the applicable Clinical Study, all information that is made, collected or otherwise generated pursuant to a Clinical Study under this Agreement, including real world data (claims data); baseline biomarker data; demographic, medical and histology data; immune monitoring data; and outcomes data (including safety, pharmacodynamics, activity and efficacy) with respect thereto. |
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1.19 “Clinical Study” means any and all tests and studies in human subjects that are required by Applicable Law, or otherwise requested or recommended by the Regulatory Authorities, to obtain, maintain or expand Regulatory Approvals for a Collaboration Product for an Indication, including Post-Approval Commitments, safety / efficacy studies, and pharmacoeconomic studies or Marketing Studies. |
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1.20 “CMC” means Chemistry, Manufacturing, and Controls information required by Applicable Law to be included or referenced in, or that otherwise support, an IND or Marketing Approval Application. |
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1.21 “Code” means the Internal Revenue Code of 1986, as amended. |
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1.22 “Collaboration” means the collaboration of the Parties with respect to the Research, Development, or Commercialization of Collaboration Constructs and Collaboration Products pursuant to the Research Program or GDP, as and to the extent set forth in this Agreement. |
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1.23 “Collaboration Allocation” means the ratio of shared costs and expenses that each Party is responsible for, and the ratio of Net Profits or Net Losses each Party is entitled to receive or bear, respectively. As of the Effective Date, and subject to adjustment as expressly set forth in this Agreement (including Sections 8.3.4 and 8.4), the Collaboration Allocation is fifty-five percent (55%) Genentech / forty-five percent (45%) Xencor. |
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1.24 “Collaboration Construct” [***]. |
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1.25 “Collaboration In-License” is defined in Section 9.8. |
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1.26 “Collaboration Product” means any product containing or comprising a Collaboration Construct. For clarity, a Collaboration Product does not include a Combination Agent. |
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1.27 “Combination Agent” means a chemical, biologic or other agent [***] that is being developed or commercialized for use in combination with a Collaboration Product, whether or not co-formulated or being developed or commercialized with one or more products other than a Collaboration Product. [***] |
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1.28 “Commercialization” means any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Collaboration Product, including activities related to marketing, promoting, distributing, and importing such Collaboration Product. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning. |
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1.29 “Commercialization Plan” is defined in Section 6.1.1. |
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1.31 “Committee” means the Joint Research Committee, Joint Development Committee, or Joint Commercialization Committee, as applicable. |
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1.32 “Competitive Change in Control” is defined in Section 6.5.5. |
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1.33 “Compulsory Sublicense” means a sublicense granted to a Third Party, through the order, decree or grant of a governmental authority having competent jurisdiction, authorizing such Third Party to manufacture, use, sell, offer for sale, import or export a Collaboration Product in any country in the world for free or for a reduced cost. |
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1.34 “Compulsory Sublicensee” means a Third Party that was granted a Compulsory Sublicense. |
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1.35 “Co-Promotion” or “Co-Promote” is defined in Section 6.5.4. |
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1.36 “Co-Promotion Agreement” is defined in Section 6.5.3. |
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1.37 “Co-Promotion Option” is defined in Section 6.5.1. |
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1.38 “Co-Promotion Candidate Product” means a Collaboration Product for which, as of the date on which Xencor exercises its Co-Promotion Option, there are no co-promotion or other co-commercialization rights granted by Genentech [***]. |
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1.39 “Co-Promotion Exercise Period” means, with respect to a Co-Promotion Candidate Product in the Co-Promotion Territory, the period beginning on the Effective Date and ending on the date that is no later than [***] after Genentech provides Xencor with the Genentech Estimate pursuant to Section 6.5.2(a); provided, however, that within such period, (a) Xencor may submit written questions to Genentech about such Co-Promotion Candidate Product within [***] |
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[***] of the receipt of such Genentech Estimate, and (b) Genentech will promptly respond to such questions no later than [***] from receipt of Xencor’s questions. |
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1.40 “Co-Promotion IP Rights” means any intellectual property rights, other than the Excluded Patents, or rights in confidential or proprietary information necessary for Xencor to exercise its rights or perform its obligations under the Co-Promotion Agreement or Commercialization Plan, to the extent Controlled by Genentech. |
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1.41 “Co-Promotion Product” is defined in Section 6.5.2(a). |
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1.42 “Co-Promotion Territory” means the United States and its territories and possessions. |
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1.45 “Contract Manufacturing Organization” or “CMO” means any Third Party contract manufacturer with which Genentech or any of their Affiliates or Xencor or its Affiliates contracts for the Manufacture of any Collaboration Construct or Collaboration Product. |
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1.47.1 When a Party Manufactures directly, the sum of: (a) the cost (as defined in each Party's Accounting Standards consistently applied) to Manufacture a Collaboration Product to the extent included pursuant to ARTICLE 7 of the Agreement, including items such as cost of materials, yield and waste levels, direct labor, etc.; (b) any additional applicable overhead, including items such as costs that relate to that Party's supervisory, occupancy, facility and equipment, etc., as calculated according to and consistent with each |
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Party's internal policies; (c) other such costs burdened to the product due to Manufacturing (including inventory write-offs and excess capacity charges); and (d) the actual costs associated with the technology transfer to a Third Party manufacturer to enable Manufacturing of that product, including without limitation any upfront and milestone based payments and startup costs associated therewith. All Cost of Manufacture shall be consistently applied to the product for ongoing clinical trials and commercialization. Cost of Manufacture shall exclude any intercompany profit or xxxx-up of costs by an Affiliate to the Parties. |
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1.47.2 When a Party uses a Third Party Manufacturer, the amount actually paid to (and not reimbursed by) each such Third Party Manufacturer, including FTE costs associated with overseeing any Third Party Manufacturer. |
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1.48 “Covered by” or “Covers,” or the like, means, with respect to a given Collaboration Product or Collaboration Construct, that the manufacture, use, sale, offer for sale, import or other Exploitation of such Collaboration Product or Collaboration Construct, but for ownership of, or a license granted in this Agreement under, a relevant Patent would infringe a Valid Claim of such Patent in the relevant country on the relevant date. The Parties acknowledge and agree that the defined term “Covers” is solely used in Section 10.9.3 and undefined use of “cover” throughout is intentional. |
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1.49 “Create Act” is defined in Section 10.6. |
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1.51 “Detailing” means an interaction between a sales representative and a prescriber for the purposes of informing such prescriber of the characteristics of the Collaboration Products and providing Product-related information or services. When used as a verb, the term “Detail” or “Detailing” means to perform a Detail. |
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1.52 “Develop” or “Development” means all development activities, other than Research, for a Collaboration Construct or the associated Collaboration Product that are directed to obtaining Marketing Approval(s) of such Collaboration Product, including all non-clinical, preclinical and clinical activities, testing and studies of such Collaboration Product performed after the date of the [***] Decision; manufacturing development, process and formulation development; toxicology, pharmacokinetic, pharmacodynamic, drug-drug interaction, safety, tolerability and pharmacological studies; distribution of such Collaboration Product for use in Clinical Studies (including placebos and comparators); statistical analyses; and the preparation, filing and prosecution of any MAA or IND for such Collaboration Product; development activities directed to label expansion (including prescribing information) or obtaining Marketing Approval for one or more additional Indications following initial Marketing Approval; development activities conducted after receipt of Marketing Approval which were a condition for the receipt of such Marketing Approval; and pharmacoeconomic studies relating to the Indication for which such Collaboration Product is being developed; in each case above, including investigator- or institution-sponsored studies for which a Party is providing material or assistance or otherwise has written obligations to such investigator or institution; and all regulatory activities related to any of the foregoing. |
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1.54 “Development Costs” means, with respect to a Collaboration Product, the FTE Costs incurred, and any direct out-of-pocket costs or expenses paid or accrued in accordance with the applicable Accounting Standard(s), by or on behalf of a Party or any of its Affiliates during the Term that are specifically identifiable or reasonably allocable to Development Activities for such Collaboration Product, in each case in accordance with the GDP or other applicable plan or activities approved by the JDC or otherwise by the Parties (including as set forth in this Agreement). Subject to the foregoing and by way of example, Development Costs may include costs in connection with the following activities: |
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(a) pre-clinical and non-clinical activities [***] such as toxicological, pharmacokinetic, metabolic or clinical activities (including toxicology and formulation development, test method development, stability testing, quality assurance, quality control development and statistical analysis) conducted internally or by individual investigators, consultants, or Third Parties necessary for the purpose of obtaining or maintaining Regulatory Approval and activities for preparing, submitting, reviewing or developing data or information for the purpose of a regulatory filing; |
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(b) Clinical Studies (including Marketing Studies and Post-Approval Commitments) for such Collaboration Product, including (i) the preparation for and Conduct of clinical trials; (ii) data collection, management, and analysis and report writing; (iii) clinical laboratory work; (iv) regulatory activities in direct connection with such studies, including adverse event recordation and reporting, but not including regulatory activities relating generally to such Collaboration Product and not directly related to such studies, such as regulatory activities relating to Marketing Approval Applications; (v) post-launch Clinical Studies, (vi) advisory meetings in connection with such Collaboration Product; and (vii) Regulatory Expenses in direct connection with Clinical Studies (including Marketing Studies and Post-Approval Commitments); |
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(c) CMC-related Development Activities, including activities relating to the development and establishment of the clinical and commercial manufacturing process for such Collaboration Product and establishment of the supply chain needed to support the GDP; |
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(e) FTE Costs incurred, and any direct out‑of‑pocket costs paid or incurred by either Party or any of its Affiliates in accordance with Accounting Standards after the Effective |
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Date that are specifically identifiable or reasonably allocable to activities classified as Development Activities (or costs or expenses classified as Development Costs) for such Collaboration Product; |
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(f) costs or expenses for Product Trademarks of such Collaboration Product prior to the First Commercial Sale of such Collaboration Product in the Territory; and |
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(g) Losses specifically identifiable or reasonably allocable to the performance of Development Activities for such Collaboration Product in accordance with the GDP to the extent treated as a Development Cost. |
Development Costs do not include any Allowable Expenses or Launch Costs.
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1.57 “DOJ” is defined in Section 17.19. |
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1.58 “Dollar” or “$” means U.S. dollars. |
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1.59 “[***] for such Collaboration Construct or Collaboration Product. |
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1.60 “Effective Date” is defined in 17.19. |
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1.61 “[***] Combination Agent” means any [***]. |
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1.64 “Execution Date” is defined in the preamble hereto. |
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1.66 “EU” or “European Union” means the member states of the EU, or any successor entity thereto performing similar functions. |
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1.68 “FDA” means the United States Food and Drug Administration, or any successor entity thereto performing similar functions. |
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1.69 “Field” means all uses in all fields without limitation. |
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1.71 “First Eligible Co-Promotion Indication” is defined in Section 6.5.2(c). |
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1.72 “Fixed SG&A” means the amount calculated by multiplying the Fixed SG&A Percentage by the Net Sales amount. |
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1.73 “Fixed SG&A Percentage” means, on a Collaboration Product-by-Collaboration Product basis, [***] |
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1.74 “FTC” is defined in Section 17.19. |
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1.76 “FTE Costs” means, with respect to a Party for any period, the FTE rate assessed consistent with internal Accounting Standards multiplied by the applicable number of FTEs of |
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such Party performing the applicable activities during such period multiplied by the applicable percentage of time such FTEs have performed the applicable activities during such period. |
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1.77 “Fv Domain” means an antigen binding region of an antibody comprising one or more complementarity-determining regions (CDRs) that bind one or more Targets. |
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1.78 “GDP Budget” means the non-binding, forecasted annual budget for the Development Activities under the GDP, on a Collaboration Product-by-Collaboration Product basis. |
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1.79 “Genentech” is defined in the preamble hereto. |
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1.80 “Genentech Core Inventions” means those Patents as of the Effective Date or during the Term and all Know-How first developed, conceived, or reduced to practice under or in connection with this Agreement, whether by on behalf of employee(s), agent(s) or consultant(s) [***] first (as between the Parties) developed, conceived or otherwise Controlled by Genentech. |
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1.81 “Genentech Estimate” is defined in Section 6.5.2. |
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1.83 “Genentech IP” means, individually and collectively, Genentech Know-How, Genentech Patents, and Patents within Genentech Core Inventions. |
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1.84 “Genentech Know-How” means the Know-How Controlled by GNE as of the Effective Date or during the Term that is reasonably necessary to Research, Develop, Manufacture or Commercialize any Collaboration Construct or Collaboration Product. Genentech Know-How includes all Know-How within the Program IP Controlled by GNE ([***]). |
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1.85 “Genentech Patents” means those Patents Controlled by GNE or its Affiliates as of the Effective Date or during the Term that are reasonably necessary to Research, Develop, Commercialize or Manufacture any Collaboration Construct or Collaboration Product. Genentech Patents excludes (a) jointly owned Program Patents and (b) Patents within Genentech Core Inventions. |
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1.86 “Genentech Product Patent” means a Patent within the Genentech Patents that was filed prior to the Effective Date that solely claims a Collaboration Construct or solely claims a Collaboration Product. |
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candidates that originate from research, preclinical development and early clinical development programs conducted by Roche’s Pharma Research and Early Development Organization (“pRED”) or GNE’s Research and Early Development Organization (“gRED”). [***] |
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1.89 “GNE” is defined in the preamble hereto. |
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1.90 “HSR Act” is defined in Section 17.19. |
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1.91 “ICH Guidelines” means guidelines set by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. |
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1.92 “IL-15” means the human IL-15 protein as identified by UniProt# P40933, and any natural and non-natural amino acid sequence variants and fragments thereof. |
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1.93 “IL-15 Sushi Domain” means the human IL-15 receptor alpha sushi domain as identified by UniProt# Q13261, and any natural and non-natural amino acid sequence variants and fragments thereof. |
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1.96 “Indemnifying Party” is defined in Section 14.3. |
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1.97 “Initial GDP” is defined in Section 4.2.1, and provided in Exhibit F. |
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1.98 “Initial Research Plan” is defined in Section 3.3. The Initial Research Plans are provided in Exhibit A and Exhibit B. |
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1.100 “Initial Targeted Collaboration Product” means any product containing or comprising an Initial Targeted Collaboration Construct. For clarity, an Initial Targeted Collaboration Product does not include a Combination Agent. |
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1.101 “Initiation” or “Initiate” means, with respect to a Clinical Study, the first dosing of the first human subject in such Clinical Study. |
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1.102 “Indication” means any separately defined, well-categorized class of human disease, syndrome or medical condition for which a separate MAA may be filed with a Regulatory Authority. Each different tumor type or a different hematological malignancy as classified by cell lineage (e.g., acute lymphoblastic leukemia is a different Indication from chronic myelogenous leukemia) shall be a separate Indication; however each different line of therapy or subpopulation of patients for a particular tumor type or hematological malignancy will not be considered a separate Indication (e.g., second line (2L) non-small cell lung carcinoma shall be considered the same Indication as first line (1L) non-small cell lung carcinoma). |
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1.103 “Inventorship” is defined in Section 10.5. |
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1.105 “Joint Development Committee” or “JDC” is defined in Section 2.3. |
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1.106 “Joint Project Team” or “JPT” is defined in Section 2.5. |
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1.108 “JPT Co-Leader” is defined in Section 2.5. |
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1.110 “Launch Costs” means the cost of launching a Collaboration Product, to the extent incurred prior to First Commercial Sale, including the costs associated with: |
(i)Agency and promotional materials (e.g., positioning, message development, core sales aid, annotated package insert, campaign, and patient materials / patient advocacy);
(ii)E-marketing (e.g., website development and other online promotion marketing);
(iii)Access solutions preparation and support materials (e.g. patient co-pay information and other assistance programs such as free drug);
(iv)Sales training meeting and materials development (including online or in person training);
(v)Nurse and pharmacist materials;
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(vi)Launch meeting and materials (e.g., motivational patient videos);
(vii)Contracting and other national accounts activities;
(viii)Promotional advisory boards (various audiences);
(ix)Promotional speaker bureaus (including medical doctors and nurses);
(x)Booth materials and visuals (e.g., videos and mechanism of action animations);
(xi)Non-promotional scientific materials and brochures;
(xii)Therapeutic area expert identification and advisory boards;
(xiii)Scientific/clinical story and message development and associated publications agency support including reprints;
(xiv)Market research, including primary and secondary market research, including payor research, and market analytics and forecasting;
(xv) Costs for Medical Affairs Activities (not including Clinical Studies, which are Development Costs) prior to the First Commercial Sale in the Territory; and
(xvi)Any other costs and expense of Genentech, its Affiliates, and its sublicensees specifically identifiable or reasonably allocable to the launch of a Collaboration Product prior to First Commercial Sale as consistently applied across its portfolio.
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1.111 “Losses” is defined in Section 14.1. |
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1.112 “Major European Countries” means France, Germany, Italy, Spain, and the United Kingdom. |
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1.114 “Manufacturing Know-How” is defined in Section 7.2.1. |
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1.115 “Manufacturing Technology Transfer Plan” is defined in Section 7.2.1. |
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1.116 “Marketing Approval Application” or “MAA” means BLA, sBLA, NDA, sNDA and any equivalent thereof in the United States or any other country or jurisdiction in the world. As used herein: “BLA” means a Biologics License Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 600 et seq., for FDA approval of a Collaboration Product and “sBLA” means a supplemental BLA; and “NDA” means a New Drug Application and amendments thereto filed pursuant to the requirements of the FDA, as defined in 21 C.F.R. § 314 et seq., for FDA approval of a Collaboration Product and “sNDA” means a supplemental NDA. |
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1.119 “Medical Affairs Activities” means, with respect to any country in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Collaboration Products, including activities of medical scientific liaisons, activities involving key opinion leaders, and the provision of medical information services with respect to a Collaboration Product. |
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1.120 “Net Profits” and, with correlative meaning, “Net Losses”, means, with respect to a Collaboration Product in a given Calendar Quarter, (a) Net Sales of such Collaboration Product, plus (b) any amounts received from a Third Party (sub)licensee (other than Chugai) in connection with granting rights to such Collaboration Product (e.g., upfront and milestone payments), less (c) Allowable Expenses (including Fixed SG&A). An example of such calculation is set forth on Exhibit D to the Agreement. |
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government pricing or discounting schemes, or other action of a government or regulatory body. Notwithstanding the foregoing, solely for the purpose of calculating Net Sales under this Agreement, any discount on Collaboration Product sold to a Third Party shall be no greater, on a weighted-average percentage basis based on the gross selling price prior to discount, than the weighted-average percentage discount applied on any Combination Agent sold for use in combination with Collaboration Product to a Third Party for the applicable accounting period. |
With respect to any sale of any Collaboration Product in a given country for any substantive consideration other than monetary consideration on arm’s length terms (which has the effect of reducing the invoiced amount below what it would have been in the absence of such non-monetary consideration), for purposes of calculating the Net Sales, such Collaboration Product shall be deemed to be sold exclusively for cash at the average Net Sales price charged to Third Parties for cash sales of such Collaboration Product in such country during the applicable reporting period (or if there were only de minimis cash sales in such country, at the fair market value as determined in good faith based on pricing in comparable markets). Notwithstanding the foregoing, Net Sales shall not include amounts at or less than Genentech’s Cost of Manufacture (whether actually existing or deemed to exist for purposes of calculation) for Collaboration Products distributed for use in Clinical Studies as consistently applied across Genentech’s portfolio. For clarity, the supply of Collaboration Product by Genentech to Xencor for a Xencor Study at a transfer price equal to the Cost of Manufacture plus [***] percent ([***]%) shall not be considered a Net Sale.
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1.123 “Non-targeted Collaboration Product” means a product containing or comprising a Non-targeted Collaboration Construct. |
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1.124 “Party” or “Parties” is defined in the preamble hereto. |
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1.126 “Patent Costs” is defined in Section 10.4.2(b). |
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1.127 “Patent Infringement” is defined in Section 10.9.1. |
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1.133 “Pivotal Study” means a Clinical Study of a Collaboration Product that is designed to demonstrate, along with previously conducted studies, substantial evidence of its effectiveness and provide sufficient information to determine whether it is safe for use under conditions prescribed, recommended, or suggested in proposed labeling, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise. |
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1.135 “Post Research Term Construct” is defined in Section 8.4.3(c). |
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1.136 “Potential In-License” is defined in Section 9.8. |
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1.137 “[***] |
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1.138 “Product Labeling” or “Product Label” means, with respect to a Collaboration Product in a country in the Territory, (a) the Regulatory Authority‑approved prescribing information for such Collaboration Product for such country, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Collaboration Product in such country. |
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1.139 “Product Trademark” means the Trademark(s) to be used for the Commercialization of Collaboration Products in the Territory and any registrations thereof or any pending applications relating thereto in the Territory (excluding, in any event, the corporate names and any trademarks, |
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service marks, names or logos that include any corporate name or logo of the Parties or their Affiliates). |
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1.140 “Program Confidential Information” means any and all proprietary information or material, whether oral, visual, in writing or in any other form, created jointly by the Parties during the course of performing Development Activities (including all JDC activities) or in connection with Commercialization of Collaboration Products hereunder (including all JCC and Co-Promotion activities), but excluding any such information or material that solely relates to one more or more (i) Xencor Core Inventions, which shall constitute the Confidential Information of Xencor (regardless of the Party initially disclosing the same), or (ii) Genentech Core Inventions, which shall constitute the Confidential Information of Genentech (regardless of the Party initially disclosing the same). |
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1.141 “Program IP” means, individually and collectively, Program Know-How and Program Patents. |
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1.142 “Program Know-How” means, any Know-How that is developed, conceived, or reduced to practice by or on behalf of, Genentech or Xencor: (i) solely or jointly in the course of conducting activities during the Research Term pursuant to a Research Plan, or (ii) solely or jointly in the course of conducting activities during the Term pursuant to the GDP, in each case of (i) and (ii), that relates solely to a Collaboration Construct or Collaboration Product, or (iii) [***]. |
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1.143 “Program Materials and Technology” means all Know-How (except for Manufacturing Know-How) and Materials that are Controlled by the applicable Party and necessary to Research, Develop or Commercialize Collaboration Constructs and Collaboration Products. Program Materials and Technology includes the initial items listed on Exhibit I that Xencor will provide. |
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1.144 “Program Patents” means Patents that cover any Program Know-How. |
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1.145 “Promotion-[***] Indication” means an Indication for which Marketing Approval for a Collaboration Product is obtained that includes a Combination Agent with respect to which Genentech has granted to a Third Party (and such Third Party has exercised) co-promotion or other co-commercialization rights. |
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1.149 “Quarterly IP Meeting” is defined in Section 10.7. |
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1.150 “Regulatory Approval” means the technical, medical and scientific licenses, registrations, authorizations and approvals required for marketing or use of a Collaboration Product (including, without limitation, approvals of, BLAs, investigational new drug applications, pre- and post- approvals, and labeling approvals and any supplements and amendments to any of such approvals) of any national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, necessary for the development, manufacture, distribution, marketing, promotion, offer for sale, use, import, export or sale of Collaboration Products in a regulatory jurisdiction. In the United States, its territories and possessions, Regulatory Approval means approval of any Marketing Approval Application or equivalent by the FDA. |
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1.151 “Regulatory Authorities” means any applicable supra-national, federal, national, regional, state, provincial, or local regulatory agencies, departments, bureaus, commissions, councils, or other government entities regulating or otherwise exercising authority with respect to the Exploitation of Collaboration Products in the Territory. |
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1.152 “Regulatory Data” means collectively all non-clinical data and Clinical Data, CMC data and other information, results, and analyses with respect to any Party’s Development activities. |
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1.153 “Regulatory Expenses” means those FTE Costs and any direct out‑of‑pocket costs (including filing, user, maintenance and other fees paid to Regulatory Authorities) paid or incurred as an expense in accordance with Accounting Standards by or on behalf of a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement, that are specifically identifiable or reasonably allocable to the preparation of regulatory submissions for, and the obtaining and maintenance of Regulatory Approval, including compliance with Regulatory Approvals and requirements of such Regulatory Authorities, adverse event recordation and reporting and regulatory affairs activities. |
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1.154 “Regulatory Materials” means any regulatory application, submission, notification, communication, correspondence, registration and other filings made to, received from or otherwise conducted with a Regulatory Authority in order to Research a Collaboration Construct or Collaboration Product or Develop, or Commercialize a Collaboration Construct or Collaboration Product in the Field in a particular country or jurisdiction. “Regulatory Materials” includes any IND, MAA and Marketing Approval. |
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1.155 “Research” or “Researched” means all research activities to discover, identify, characterize or optimize the Collaboration Constructs and all preclinical research on Collaboration Constructs or Collaboration Products, conducted prior to the date of the [***] Decision. |
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1.156 “Research Plan” is defined in Section 3.1. |
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1.157 “Research Program” means the activities conducted by the Parties pursuant to any and all Research Plans. |
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1.158 “Research Target” is defined in Section 3.3. |
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1.160 “Reversion Technology” means, [***] |
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1.161 [***] |
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1.162 “Royalty Conversion” is defined in Section 8.4.3(b). |
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1.163 “Royalty Conversion Notice” is defined in Section 8.4.3(b). |
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1.164 “Royalty Product” means a Collaboration Product that has been the subject of a Royalty Conversion pursuant to Section 8.3.4 or Section 8.4.3. |
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1.167 “Sales” means, with respect to a Collaboration Product in a particular period, the sum of clauses (a) and (b) below: |
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(a) the amount stated in the “Sales” line for such Collaboration Product in the externally published audited financial statements of X. Xxxxxxxx-Xx Xxxxx Ltd (Genentech’s ultimate parent company) for such period, or if no separate “Sales” line for such Collaboration Product exists in such externally published audited financial statements, then sales of such Collaboration Product that are reflected therein as part of any other line; and |
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[***] |
For clarity, the amount referenced in clause (a) above does not include any sales or other dispositions of the Collaboration Product between or among any of Genentech, its Affiliates, or its or their sublicensees (except to the extent such entity is the ultimate end user of the Collaboration Product). In addition, the amount referenced in clause (a) above does not includes any sales or other dispositions of the Collaboration Product by Genentech, its Affiliates or its or their sublicensees (i) as samples, (ii) for use in non-clinical or clinical studies, (iii) for use in any tests or studies reasonably necessary to comply with any applicable Law, or (iv) for another reasonable and customary use in the industry, in each case of (i) – (iv), inclusive, as long as such sale or disposition was made at or below the cost of supplying the Collaboration Product.
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(i) credits, reserves or allowances granted for (1) damaged, outdated, returned, rejected, withdrawn or recalled Collaboration Product, wastage replacement, and short-shipments; (2) billing errors; and (3) indigent patient and similar programs (e.g., price capitation); |
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(ii) governmental price reductions and government mandated rebates; |
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(iii) chargebacks, including those granted to wholesalers, buying groups and retailers; |
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(iv) customer rebates including cash sales incentives for prompt payment, cash and volume discounts; and |
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(v) taxes, duties and any other governmental charges or levies imposed upon or measured by the import, export, use, manufacture or sale of a Collaboration Product (excluding income and franchise taxes). |
Except as may otherwise be set forth herein, Sales shall be calculated on an accrual basis in accordance with the then-currently used Accounting Standard.
In the event a Collaboration Product is sold for a single price in combination with one or more Combination Agents under this Agreement (as used in this definition of Sales, a “Combination”), then for each particular period and on a country-by-country basis, the gross amount invoiced for that Collaboration Product shall be calculated by multiplying the gross amount invoiced for such Combination by the fraction A/(A+B), where “A” is the gross amount invoiced for the Collaboration Product sold separately and “B” is the gross amount invoiced for the Combination Agent(s) sold separately. In the event that the Combination Agent(s) is not sold separately, then
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the gross amount invoiced for that Collaboration Product shall be calculated by multiplying the gross amount invoiced for the Combination by the fraction A/C, where “A” is the gross invoice amount for the Collaboration Product, if sold separately, and “C” is the gross invoice amount for the Combination. In the event that a particular Combination is not addressed by the foregoing, “Sales” of the Collaboration Product sold in a Combination shall be determined by the Parties in good faith for the purposes of calculating the Net Profit / Net Loss split, or if a Royalty Conversion has occurred, calculating royalties, in either case, that reflects a reasonable allocation to the portion of the Combination that is the Collaboration Product.
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1.169 “Study Proposal” has the meaning set forth in Section 4.6.1. |
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1.171 “Subsequent Targeted Collaboration Product” means any product containing or comprising a Subsequent Targeted Collaboration Construct. For clarity, Subsequent Targeted Collaboration Product does not include a Combination Agent. |
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1.172 “Supply Agreement” is defined in Section 7.1.1. |
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1.174 “Targeted Collaboration Construct” means an Initial Targeted Collaboration Construct or a Subsequent Targeted Collaboration Construct. |
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1.175 “Targeted Collaboration Product” means any product containing or comprising a Targeted Collaboration Construct. For clarity, Targeted Collaboration Product does not include a Combination Agent. |
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1.176 “Tax” or “Taxes” is defined in Section 8.7.4. |
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1.177 “Tax Representative” means, for U.S. federal income tax purposes, the “partnership representative”, as such term is defined in Section 6223 of the Code (as amended by the amendments to the Code that were enacted as section 1101 of the Bipartisan Budget Act of 2015, P.L. 114-74). |
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1.178 “Technology Transfer Plan” is defined in Section 4.4. |
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1.180 “Termination Product” means, with respect to a termination of this Agreement with respect to a Collaboration Product, any such Collaboration Product [***] occurred prior to the effective date of such termination. |
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1.181 “Termination Subject Matter” is defined in Section 15.3.1. |
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1.182 “Territory” means worldwide. |
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1.183 “Third Party” means any entity other than Xencor, GNE, and Roche or an Affiliate of any of the foregoing. |
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1.185 “Third Party Fc Royalty Payments” is defined in Section 10.8. |
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1.186 “Third Party Infringement Claim” is defined in Section 10.10.1. |
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1.187 “Third Party IP Payments” means any and all upfront payments, milestone payments, royalties, and other amounts paid to a Third Party under a Collaboration In-License to the extent solely attributable to Collaboration Products; provided, that Third Party IP Payments do not include any Third Party Fc Royalty Payments. |
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1.189 “Trademark” means any word, name, symbol, color, designation or device or any combination thereof that functions as a source identifier, including any trademark, trade dress, brand xxxx, service xxxx, trade name, brand name, logo or business symbol, whether or not registered. |
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1.190 “Transfer Agreement” is defined in Section 15.3.7(b). |
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1.193 “Valid Claim” means, with respect to a particular country, a claim of an issued and unexpired Patent in such country that has not been disclaimed, revoked, held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, unappealable or unappealed within the time allowed for appeal, and that has not been finally abandoned, admitted to be invalid or unenforceable through re-examination, re-issue, disclaimer or otherwise, or lost in an interference proceeding. |
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1.194 “VAT” means, in the EU, value added tax calculated in accordance with Council Directive 2006/112/EC and, in a jurisdiction outside the EU, any equivalent tax. |
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1.196 “Xencor Approved CMOs” are: |
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(1) |
[***] |
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(2) |
[***] |
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(3) |
[***] |
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(4) |
[***] |
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4.1 “Xencor Core Inventions” means those Patents as of the Effective Date or during the Term and all Know-How first developed, conceived, or reduced to practice under or in connection with this Agreement, whether by on behalf of employee(s), agent(s) or consultant(s) [***] first (as between the Parties) developed, conceived or otherwise Controlled by Xencor. |
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4.2 “Xencor Fc Patent Infringement” is defined in Section 10.9.1. |
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4.3 “Xencor Fc Patents” means any and all Patents Controlled by Xencor as of the Effective Date or during the Term that cover an Fc Domain. For clarity, Xencor Fc Patents do not claim IL-15. |
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4.4 “Xencor Fc Technology” means Xencor’s proprietary Fc Domain engineering platform covered by Xencor Fc Patents and Know-How Controlled by Xencor. |
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4.5 “Xencor IND” is defined in Section 5.1.3. |
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4.6 “Xencor IP” means, individually and collectively, the Xencor Know-How, Xencor Patents, Patents within Xencor Core Inventions, and Xencor Fc Patents. |
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4.7 “Xencor Indemnitee” is defined in Section 14.2. |
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4.8 “Xencor Initial Supply” is defined in Section 7.1.1. |
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4.9 “Xencor Know-How” means Know-How Controlled by Xencor or its Affiliates as of the Effective Date or during the Term that is reasonably necessary to Research, Develop, Manufacture or Commercialize any Collaboration Construct or Collaboration Product. Xencor Know-How includes all Know-How within the Program IP Controlled by Xencor [***]. |
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4.10 “Xencor Manufacturing Technology” means the manufacturing-related Know-How set forth on Exhibit H. |
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4.11 “Xencor Patents” means those Patents Controlled by Xencor or its Affiliates as of the Effective Date or during the Term that are reasonably necessary to Research, Develop, Commercialize or Manufacture any Collaboration Construct or Collaboration Product, including those Patents set forth in Exhibit K. Xencor Patents excludes (a) jointly owned Program Patents, (b) Patents included in Xencor Fc Patents, (c) Patents within Xencor Core Inventions, and (d) Patents that cover Fv Domains other than those specific to a Research Target. |
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4.12 “Xencor Platform Product” means a construct containing Xencor Fc Technology that is not a Collaboration Construct. |
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4.13 “Xencor Product Patent” means a Patent within the Xencor Patents that was filed prior to the Effective Date that solely claims a Collaboration Construct or solely claims a Collaboration Product. |
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4.14 “Xencor Study” is defined in Section 4.6.1. |
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4.15 “XmAb24306” [***]. |
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4.16 “XmAb24306 Product” means a product containing or comprising XmAb24306. |
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(a) approving each Research Plan; |
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(b) coordinating the activities of the Parties under the Research Plan(s) and overseeing the implementation of the Research Plan(s); |
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(c) preparing and approving annual or interim amendments to the Research Plan(s) during the Research Term; |
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(d) providing a forum for and facilitating communications between the Parties [***]; |
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(e) providing a forum for Genentech to elect up to [***] Research Target(s) in a Research Plan(s); |
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(f) establishing joint subteams, as appropriate, to carry out its functions; and |
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(g) performing such other functions as may be appropriate to further the purposes of this Agreement with respect to the Research of Collaboration Constructs, to the extent delegated to the JRC by mutual written agreement of the Parties after the Effective Date. |
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2.2.2 Decision Making. With respect to the decisions of the JRC, each Party shall have one (1) collective vote in all decisions, and the Parties shall attempt to make decisions by reaching unanimous agreement; provided, that the Parties acknowledge and agree that votes shall not be ratified until each Party has undertaken all necessary internal procedures and governance to provide a vote that such Party can implement. If, after reasonable discussion and good faith consideration of each Party’s view on a particular matter, the JRC cannot reach agreement within [***] after the date such matter was initially brought to a vote, then, the matter shall be referred for resolution to a VP/SVP Partnering at Genentech and the Chief Executive Officer at Xencor who shall promptly initiate discussions in good faith to resolve the disputed matter. If the disputed matter is not resolved by such executives within [***], or such longer period as the Parties may agree in writing (which may be by email), after the date the executives first meet to consider such disputed matter, Genentech shall, subject to Section 2.6, have final decision making authority. |
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2.2.3 Meetings; Attendees; Agendas. Once established, the JRC shall meet at least once each [***] (unless otherwise agreed by the Parties) during the Research Term. No later than [***] prior to any meeting of the JRC (or such shorter time period as the Parties may agree), the Parties will prepare and circulate an agenda for such meeting, provided however, that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JRC may meet in person or via teleconference, video conference, or the like, provided that at least one meeting per [***] shall be held in person, unless otherwise agreed by the Parties. Each Party shall bear the expense of its respective representatives’ participation in the JRC meetings. Each Party may invite a reasonable number of employees, consultants, or scientific advisors to attend the JRC meetings, provided that such invitees are bound by appropriate confidentiality obligations. |
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2.2.4 Meeting Minutes. Genentech shall be responsible for keeping minutes of the JRC meetings that record in writing all decisions made, action items assigned or completed, and other appropriate matters. Meeting minutes shall be sent to both Parties promptly after a meeting for review, comment and approval by each Party. Any material modifications to a Research Plan approved at a JRC meeting shall constitute an amendment to such Research Plan upon approval by both Parties of the meeting minutes related thereto. |
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2.2.5 Term of JRC Operations. The JRC shall continue to exist until the end of the Research Term, unless the JRC is earlier disbanded by Genentech pursuant to Section 17.15. Thereafter, the JRC shall cease operations and perform no further functions hereunder. |
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2.3.1 Responsibilities of the JDC. The JDC shall be responsible for performing the following functions: |
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(a) coordinating the initial transfer of information and materials related to the Collaboration Constructs existing as of the Effective Date, including XmAb24306, from Xencor to Genentech in furtherance of the Initial GDP; |
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(b) overseeing and monitoring the progress of the Development Activities of the XmAb24306 Product and all other Collaboration Products, including all Clinical Studies under the GDP; |
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(c) providing a forum for and facilitating communications between the Parties with respect to the Development Activities of the XmAb24306 Product and all other Collaboration Products; |
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(d) reviewing and amending the Global Development Plan and GDP Budget; |
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(e) performing such other functions as specified in this Agreement or agreed to by the Parties in writing; |
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(f) reviewing Proposed Studies and deciding (i) whether to approve or reject a Proposed Study pursuant to Section 4.6.1, and (ii) whether to include a Proposed Study in the GDP; and |
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(g) reviewing and deciding whether to approve investigator-sponsored studies. |
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2.3.2 Decision Making. With respect to the decisions of the JDC, each Party shall have one (1) collective vote in all decisions, and the Parties shall attempt to make decisions by reaching unanimous agreement; provided, that the Parties acknowledge and agree that votes shall not be ratified until each Party has undertaken all necessary internal procedures and governance to provide a vote that such Party can implement. If, after reasonable discussion and good faith consideration of each Party’s view on a particular matter, the JDC cannot reach agreement within [***] after the date such matter was initially brought to a vote, then, the matter shall be referred for resolution to a VP/SVP Partnering at Genentech and the Chief Executive Officer at Xencor (or his or her designee) who shall promptly initiate discussions in good faith to resolve the disputed matter. If the |
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disputed matter is not resolved by such executives within [***], or such longer period as the Parties agree, after the date the executives first meet to consider such disputed matter, Genentech shall, subject to Section 2.6.2, have final decision making authority. |
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2.3.3 Meetings; Attendees; Agendas. Once established, the JDC shall meet at least once each Calendar Quarter (unless otherwise agreed by the Parties) so long as the Parties are conducting Development Activities with respect to the XmAb24306 Product or any other Collaboration Product. No later than [***] prior to any meeting of the JDC (or such shorter time period as the Parties may agree), the Parties will prepare and circulate an agenda for such meeting, provided however, that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JDC may meet in person or via teleconference, video conference, or the like, provided that at least one meeting per [***] shall be held in person, unless otherwise agreed by the Parties. Each Party shall bear the expense of its respective representatives’ participation in the JDC meetings. Each Party may invite a reasonable number of employees, consultants, or scientific advisors to attend the JDC meetings, provided that such invitees are bound by appropriate confidentiality obligations. |
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2.3.4 Meeting Minutes. Genentech shall be responsible for keeping minutes of the JDC meetings that record in writing all decisions made, action items assigned or completed, and other appropriate matters. Meeting minutes shall be sent to both Parties promptly after a meeting for review, comment and approval by each Party. Any (a) material modifications to the GDP approved at a JDC meeting shall constitute an amendment to the GDP, and (b) decisions by the JDC related to any Proposed Studies shall be made, in each case upon approval by both Parties of the meeting minutes related thereto. |
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2.3.5 Term of JDC Operations. The JDC shall continue to exist until the completion of all Development Activities, at which time it shall automatically cease operations, unless earlier disbanded: |
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(a) by the Parties pursuant to mutual agreement, or |
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(b) by Xencor; or |
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(c) by Genentech providing timely written notice to Xencor of its election to disband the JDC pursuant to Section 17.15. |
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(a) review and discuss the Commercialization Plan, including budget, for each Collaboration Product, including, in each case, any amendments thereto, |
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(b) provide an overview of the launch activities for each Collaboration Product; |
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(c) perform an annual review of the sales force allocation for Co-Promotion Products in the Commercialization Plan and prepare any updates or amendments thereto, |
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(d) oversee implementation of each Commercialization Plan, |
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(e) to coordinate activities designed to create, provide training for, deploy and manage a sales force for the Collaboration Products; and |
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(f) to coordinate regarding sales force responsibilities, and to communicate adjustments in sizing of those sales forces for each Collaboration Product as appropriate. |
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2.4.2 Decision Making. The JCC shall make decisions unanimously, and each Party’s representatives shall collectively have one (1) vote; provided, that the Parties acknowledge and agree that votes shall not be submitted until each Party has undertaken all necessary internal procedures to provide a vote that such Party can implement. In the event the JCC cannot reach an agreement regarding a decision within the JCC’s authority for a period of [***], Genentech shall, subject to Section 2.6.2, have final decision making authority. |
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2.4.3 Meetings; Attendees; Agendas. Once established, the JCC shall meet at least once each [***] (unless otherwise agreed by the Parties) so long as the Parties are conducting Commercialization activities with respect to any Collaboration Products. No later than [***] prior to any meeting of the JCC (or such shorter time period as the Parties may agree), the Parties will prepare and circulate an agenda for such meeting, provided however, that either Party may propose additional topics to be included on such agenda, either prior to or in the course of such meeting. The JCC may meet in person or via teleconference, video conference, or the like, provided that at least one meeting per [***] shall be held in person, unless otherwise agreed by the Parties. Each Party shall bear the expense of its respective representatives’ participation in the JCC meetings. Each Party may invite a reasonable number of employees, consultants, or scientific advisors to attend the JCC meetings, provided that such invitees are bound by appropriate confidentiality obligations. |
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2.4.4 Meeting Minutes. Genentech shall be responsible for keeping minutes of the JCC meetings that record in writing all decisions made, action items assigned or completed, and other appropriate matters. Meeting minutes shall be sent to both Parties promptly after a meeting for review, comment and approval by each Party. Any material modifications to the Commercialization Plan approved at a JCC meeting shall constitute an amendment to the Commercialization Plan upon approval by both Parties of the meeting minutes related thereto. |
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2.4.5 Term of JCC Operations. The JCC shall exist only during the period in which Xencor is performing Co-Promotion activities with respect to a Co-Promotion Product under this Agreement. |
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2.6.1 Authority of Committees. The JRC, JDC and JCC shall only have the powers expressly assigned to it in this ARTICLE 2 and elsewhere in this Agreement and shall not have the authority to: (a) modify or amend the terms and conditions of this Agreement; (b) waive either Party’s compliance with the terms and conditions of under this Agreement; or (c) determine any such issue in a manner that would conflict with the express terms and conditions of this Agreement. |
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replaced with references to Genentech), assume all decision making authority previously vested in such Committee. Thereafter, the Alliance Managers shall be the contact persons for the exchange of information under this Agreement and the Parties shall handle directly between themselves the matters previously delegated to the disbanded Committee(s), including decision-making authority in the event of a dispute in accordance with Section 2.6. [***] |
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3.4 Conduct of Research. Each Party shall use diligent efforts to carry out the Research activities assigned to it in each Research Plan and shall conduct such activities in good scientific manner, and in compliance with all Applicable Laws. Each Party shall keep the other Party reasonably informed, through meetings of the JRC, as to its progress in the conduct of each Research Plan as well as with respect to other Research done involving IL-15 [***] or a proposed modification to an existing Research Plan or the GDP. [***]. |
In the event Genentech desires to conduct Research with respect to Collaboration Constructs, or the associated Collaboration Products, for use in combination with an [***] Combination Agent Controlled by Genentech, then at least [***] prior to the next regularly scheduled JRC meeting, Genentech shall provide the JRC with a written summary of such Research for its approval for Genentech to conduct such Research, and any further Research of such combination, outside a Research Plan, which decision shall be reflected in the minutes of the JRC. If the JRC so approves, then, as between the Parties, the following shall apply:
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(a) Genentech (or its Affiliate or sublicensee) shall have the sole right, at its discretion and its own expense, to conduct Research on Collaboration Constructs and the associated Collaboration Products for use in combination with such [***] Combination Agent and all other Research activities of such combination outside a Research Plan and related Research Program, and none of the terms and conditions of this Agreement specifically addressing (i) Research Plans or related Research Programs or (ii) activities pursuant to or under a Research Plan hereunder shall apply to any such activities, including keeping Xencor reasonably informed of such activities pursuant to this Section 3.4. For clarity, terms and conditions that do not specifically address a Research Plan shall remain applicable, including the obligations to maintain records in accordance with Section 3.5; and |
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(b) Genentech shall solely own any new Know-How and Patents developed, conceived, or reduced to practice in the course of conducting such Research activities with respect to a Collaboration Construct or Collaboration Product for use in combination with such [***] Combination Agent or any other Research activities of such combination, and none of the terms of Article 10 (except Sections 10.6, 10.10, 10.11, 10.13) shall apply to such Know-How and Patents, provided that any such new Know-How and Patents would be considered Genentech IP and Confidential Information of Genentech for purposes of the other terms of the Agreement, to the extent such terms with respect to Genentech IP and Confidential Information do not conflict with the rights granted to a Third Party. |
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any Patent issuing therefrom. All records shall be maintained by the Parties, as appropriate, during the applicable Research Program and for at least [***] thereafter. |
In the event Genentech desires to Conduct a Clinical Study of a Collaboration Construct or Collaboration Product for use in combination with an [***] Combination Agent Controlled by Genentech, then at least [***] prior to the next regularly scheduled JDC meeting, Genentech shall provide the JDC with a written proposal of such Clinical Study in accordance with the requirements of Section 4.6.1 (applied mutatis mutandis with references to Xencor replaced with references to Genentech and Proposed Study deemed to include a Collaboration Product or Collaboration Construct and an [***] Combination Agent), or if such requirements of Section 4.6.1 conflict with the rights granted to a Third Party with respect to such [***] Combination Agent, then a high-level summary of
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such Clinical Study (which high-level summary will at a minimum include the identity of the [***] Combination Agent and the anticipated safety outcomes), for its approval for Genentech to Conduct such Clinical Study, and any further Development of such combination, outside the GDP, which decision shall be reflected in the minutes of the JDC.
With respect to an [***] Combination Agent Controlled by Genentech, if the JDC so approves, then, as between the Parties, the following shall apply:
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(a) Genentech (or its Affiliate or sublicensee) shall have the sole right, at its discretion and its own expense, to Conduct such Clinical Study of a Collaboration Construct or Collaboration Product for use in combination with such [***] Combination Agent and all other Development of such combination outside the GDP, and none of the terms and conditions specifically addressing Development Activities (i.e., activities pursuant to or under the GDP hereunder), shall apply to any such activities, including sharing of related records and reports (including Clinical Data) pursuant to Section 4.7 and sharing of related Development Costs pursuant to Section 8.3. For clarity, terms and conditions that do not specifically address Development Activities (i.e., activities pursuant to or under the GDP hereunder) shall remain applicable, including the obligations to maintain records in accordance with Section 4.7.1 (applies mutatis mutandis to such [***] Combination Agent Development); |
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(b) Genentech (or its Affiliate or sublicensee) shall have the sole right and responsibility to prepare and submit Regulatory Materials and to file for, obtain, and maintain Regulatory Approvals for such Collaboration Product for use in combination with such Encumbered Combination Agent, and none of the terms of Article 5 (other than Section 5.4) shall apply to any such activities. For clarity, the foregoing does not limit Genentech’s obligation to allow Xencor to cross reference INDs owned by Genentech for the relevant Collaboration Product, as applicable under Section 5.1.3; |
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(c) Genentech shall solely own any new Know-How and Patents developed, conceived, or reduced to practice in the course of conducting such Clinical Study of a Collaboration Construct or Collaboration Product for use in combination with such [***] Combination Agent or any other Development of such combination, and none of the terms of Article 10 (except Sections 10.6, 10.10, 10.11, 10.13) shall apply to such Know-How and Patents; provided that any such new Know-How and Patents would be considered Genentech IP and Confidential Information of Genentech for purposes of the other terms of the Agreement, to the extent such terms with respect to Genentech IP and Confidential Information do not conflict with the rights granted to a Third Party; and |
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(d) Genentech (itself or through its Affiliates or sublicensees) shall have the sole right to Commercialize such [***] Combination Agent (and such Collaboration Product for use in combination with such Encumbered Combination Agent); provided that any sales of Collaboration Products sold for use in combination with such Combination Agent shall be subject to sharing Net Profits and Net Losses of Collaboration Products, or if a Royalty Conversion has occurred, reasonable royalty payments, pursuant to Section 8.4; |
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provided, however, in the event Genentech obtains (i) some of the rights granted to Xencor hereunder with respect to such Development of a Collaboration Construct or Collaboration Product for use in combination with such [***] Combination Agent as if such Development were included hereunder as Development Activities under the GDP (which, at a minimum, would include the rights to share with Xencor the Clinical Data of such Clinical Study and any such further Clinical Study(ies) as set forth under Section 4.7.2 and the rights and licenses to use such Clinical Data as set forth under Section 9.3), then the Parties may, at each Party’s sole discretion, agree to include such Development and Commercialization of such combination under this Agreement and amend this Agreement to reflect any revisions as needed to any terms and conditions with respect thereto, except that the terms of sharing of Development Costs and sharing of Net Profits and Net Losses in accordance with the Collaboration Allocation as set forth under Sections 8.3 and 8.4, respectively, shall govern such Development and Commercialization; or
(ii) substantially similar rights to all of the rights granted to Xencor hereunder with respect to such Development of a Collaboration Construct or Collaboration Product for use in combination with such Encumbered Combination Agent as if such Development were included hereunder as Development Activities under the GDP, then Genentech shall provide written notice to Xencor that such rights have been obtained and upon receipt of such notice, such Development shall be included as “Development Activities” under this Agreement from the date of receipt of such notice, and all of the terms and conditions specifically addressing Development Activities (i.e., activities pursuant to or under the GDP hereunder), shall apply to any such activities, including terms of sharing of Development Costs and sharing of Net Profits and Net Losses in accordance with the Collaboration Allocation as set forth under Sections 8.3 and 8.4.
For clarity, the Pharmacovigilance Agreement shall govern any such Development by Genentech outside the GDP approved by the JDC in accordance with this Section 4.2.3 as contemplated in Section 5.4.
In the event Genentech conducts any Development of a Collaboration Construct or Collaboration Product for use in combination with such [***] Combination Agent outside the GDP as set forth in this Section 4.2.3, then Xencor shall have no obligations to Genentech under this Agreement with respect to such Development, except as set forth under this Section 4.2.3 above.
If the JDC does not approve such Clinical Study with respect to such [***] Combination Agent as set forth in this Section 4.2.3 above, then Genentech shall not conduct any Development for a Collaboration Product for use in combination with such [***] Combination Agent, unless and until the Parties otherwise agree in writing.
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4.3 Diligence. |
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4.3.1 Each Party shall use Commercially Reasonable Efforts to conduct the Development Activities assigned to it under the GDP. |
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regarding whether a given Collaboration Product that is put up for an [***] Decision receives a positive or negative [***] Decision. |
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4.5.1 Genentech’s Conduct of Development Activities will be subject to oversight by the JDC and Genentech shall (i) provide regular updates on the status and results of its Development Activities to the JDC, including reporting the achievement of key Clinical Study and development milestones to be determined by the JDC, and (ii) inform the JDC of any material changes to the Development Activities. |
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4.5.2 Genentech shall Conduct all Development (including Development Activities and any Development that includes [***] Combination Agents) for which it is responsible in a timely and effective manner according to ICH Guidelines, Applicable Law and the requirements of any applicable Regulatory Authority(ies). |
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4.6.2 Criteria Applied to JDC Approval or Rejection of Proposed Studies. The JDC (with Genentech having final decision-making authority) may approve for any reason or reject a Proposed Study solely on one or more of the following criteria: (i) the Proposed Study will create a [***] (provided, that, this subclause (iii) shall only be effective until such time as the [***] patients administered, at [***] the Collaboration Product included in the Proposed Study), or (iv) the Proposed Study will adversely or negatively impact the Commercialization of any Collaboration Product, with such adverse or negative impact meaning an anticipated reduction of Net Sales by [***] percent ([***]%) or more. If the JDC (with Genentech having final decision-making authority) rejects the Proposed Study based on reasonably supported consideration of the foregoing subclauses (i)-(iv), inclusive, then such decision shall be reflected in the minutes of the JDC. |
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(b) Xencor shall conduct such Xencor Study as the entity that takes responsibility for Initiating such Xencor Study under an IND held by Xencor. |
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(c) Such Xencor Study will be subject to oversight by the JDC, and Xencor shall (i) provide regular updates on the status and results of such Xencor Study to the JDC, including reporting the achievement of key Clinical Study and development milestones, and (ii) inform the JDC of any material changes to the Study Proposal (including study designs and protocols) for such Xencor Study. Genentech, through the JDC, shall be permitted to provide Xencor with comments on the development plans for such Xencor Study and on the conduct of the Xencor Study, and Xencor shall consider all such comments in good faith. Notwithstanding the foregoing, any modifications to the protocol for such Xencor Study that would (individually or collectively) constitute material deviations from the protocol in the Study Proposal originally presented to the JDC shall require the prior approval of the JDC. Examples of material deviations include any of the following circumstances: |
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(i) as a result of the modifications to the protocol, the Xencor Study [***], |
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(ii) as a result of the modifications to the protocol, the Xencor Study [***] |
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[***] as applicable, |
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(iii) as a result of the modifications to the protocol, the Xencor Study will [***] patients administered, [***], the Collaboration Product included in the Xencor Study), and |
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(iv) as a result of the modifications to the protocol, the Xencor Study [***] percent ([***]%) or more. |
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(d) Xencor shall conduct such Xencor Study according to ICH Guidelines, Applicable Law and the requirements of any applicable Regulatory Authority(ies). |
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(e) Unless otherwise agreed to by the Parties, such Xencor Study may only involve an agent other than the Collaboration Product (as either a Combination Agent or comparator agent) in one of the following circumstances: |
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(i) If Xencor proposes to conduct a Xencor Study in which a Collaboration Product would be combined with or compared to an agent owned or Controlled by Xencor, then Xencor may pursue such combination with such agent if (A) the safety of such agent owned or Controlled by Xencor to proceed at proposed dose levels and durations has been demonstrated in a [***], and (B) such agent is either (1) already a Combination Agent in an ongoing or completed Clinical Study within the GDP or (2) in a given Class of Agents that is not then in the GDP as a Combination Agent. |
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(ii) If Xencor proposes to conduct a Xencor Study in which a Collaboration Product would be combined with or compared to one or more agents owned or Controlled by a Third Party, then Xencor may pursue such combination with such agent only if all of the following conditions are met: (A) such agent is either (1) a Combination Agent that is or was within the GDP or (2) in a given Class of Agents that is not then in the GDP as a Combination Agent or (3) an Encumbered Combination Agent that is not under Development by Genentech as approved by the JDC pursuant to Section 4.2.3, (B) such agent is commercially available and approved in the relevant Indication, (C) Xencor (and not the Third Party commercializing or Controlling such agent) conducts the combination clinical study using quantities of the Third Party's agent acquired by Xencor through one or more arm's length purchases on the open market, (D) Xencor does not share any data arising from such study or any Program Confidential Information with the Third Party, (E) Xencor does not share with such Third Party any Genentech Confidential Information or any Confidential Information of both Parties under this Agreement, (F) Xencor does not share with Genentech any confidential information of the Third Party owning or Controlling such agent, and (G) Xencor does not enter into any agreement with the applicable Third Party regarding either (x) the supply by such Third Party of its agent for such study or (y) the sharing of data arising from such study. |
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For clarity, Xencor shall not Initiate such Xencor Study as permitted hereunder until after execution of the Pharmacovigilance Agreement by both Parties pursuant to Section 5.4.
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4.8.1 if the data was generated from a [***] Clinical Trial, Genentech shall reimburse Xencor [***] of its costs and expenses incurred by or on behalf of Xencor to conduct such trial [***]; and |
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4.8.2 if data was generated from a [***] Clinical Trial, then Genentech shall reimburse Xencor [***] of its costs and expenses incurred by or on behalf of Xencor to conduct such trial [***]. |
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4.8.3 Xencor shall submit to Genentech an invoice setting forth in reasonable detail such costs and expenses to be reimbursed in accordance with the foregoing, which costs and expenses shall be specifically identifiable or reasonably allocable to the conduct of such trial as determined in accordance with the applicable Accounting Standard. Unless disputed, Genentech shall pay such invoice within [***] after receipt. In the event of any disagreement with respect to the calculation of such costs and expenses, any undisputed |
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portion of such costs and expenses to be reimbursed will be paid in accordance with the foregoing timetable and the remaining, disputed portion will be paid within [***] after the date on which Xencor and Genentech, using good faith efforts, resolve the dispute. In addition, each Party will consider in good faith other reasonable procedures proposed by the other Party for sharing financial information in order to permit each Party to close its books periodically in a timely manner. |
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4.9 Investigator-Sponsored Studies. All investigator-sponsored studies shall be reviewed and approved by the JDC. Neither Party may Conduct, or otherwise support (including providing funding or clinical supplies of Collaboration Product) any investigator-sponsored studies of the Collaboration Products without first obtaining the JDC’s approval. Any such approved activities with respect to investigator-sponsored studies of the Collaboration Products shall be considered Development Activities. |
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4.10 Compliance. Each Party shall perform or cause to be performed, any and all of the Development Activities for which it is responsible in good scientific manner and in compliance with all Applicable Laws. |
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5.1 Regulatory Activities. |
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5.1.1 Except as set forth in Section 5.1.3, Genentech (or its Affiliate or sublicensee) shall have the sole right and responsibility to prepare and submit Regulatory Materials and to file for, obtain, and maintain Regulatory Approvals (including the setting of the overall regulatory strategy therefor) for Collaboration Products. Xencor shall use Commercially Reasonable Efforts to support Genentech, as may be reasonably necessary, in obtaining such Regulatory Approvals for the Collaboration Products, and in the activities in support thereof, including providing information, documents or other materials required by Applicable Law for inclusion in or in support of Regulatory Materials, in each case in accordance with the terms and conditions of this Agreement and the GDP. For clarity, each Party’s costs in connection with the foregoing shall be Development Costs. |
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5.1.2 Except as set forth in Section 5.1.3, all Regulatory Materials relating to the Collaboration Products shall be owned by, and shall be the sole property and held in the name of, Genentech or its designated Affiliate, sublicensee or designee. All Regulatory Approvals and Product Labeling relating to the Collaboration Products shall be owned by, and shall be the sole property and held in the name of, Genentech or its designated Affiliate, sublicensee or designee. Without limiting the foregoing, each Party shall have the right to (i) reasonably attend regulatory interactions (including face-to-face meetings and phone calls) with Regulatory Authorities for any Collaboration Product and (ii) the review and comment rights provided in Section 5.1.4. The Parties will agree upon a reasonable number of representatives from each Party to participate in any such regulatory interactions, subject to any feedback from applicable Regulatory Authorities. |
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5.2.1 For clinical and commercial manufacture by Xencor or Genentech of Collaboration Products, Xencor or its CMO shall consult with Genentech, and provide to Genentech all CMC-related documents and input as required by Genentech (or its Affiliate) or any applicable Regulatory Authority in connection with any Regulatory Materials to be submitted to any applicable Regulatory Authority by Genentech (or its Affiliate) in order to obtain any required Regulatory Approvals in the Territory. Xencor shall, and shall cause its CMOs to, use Commercially Reasonable Efforts to develop any new data or documents in support of Genentech regulatory activities with respect to Collaboration Products; provided, however, that any expenses incurred therewith shall be Development Costs. |
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5.2.2 For clinical manufacture by Genentech of Collaboration Products used in Xencor Studies, Genentech or its subcontractors shall consult with Xencor, and provide to Xencor all CMC-related documents and input as required by Xencor (or its Affiliate) or any applicable Regulatory Authority in connection with any Regulatory Materials to be submitted to any applicable Regulatory Authority by Xencor (or its Affiliate) in order to obtain any required Regulatory Approvals in the Territory (for purposes of performing the Xencor Studies). Genentech shall, and shall cause its subcontractors to, use Commercially Reasonable Efforts to develop any new data or documents in support of Xencor regulatory activities in connection with performing the Xencor Studies; provided, however, that any expenses incurred therewith shall be Development Costs associated with a Xencor Study and shall be borne pursuant to Section 8.3.2. |
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5.2.3 For Manufacture by Genentech of Collaboration Products, in addition to Section 5.2.1, Xencor shall (a) consult with and otherwise provide support to Genentech on CMC-related regulatory matters, as requested by Genentech and (b) assist Genentech (or its Affiliate) in responding to requests and inquiries from Regulatory Authorities prior to, during and after regulatory review periods, and attending meetings with Regulatory Authorities to the extent Genentech requests Xencor to participate given its unique knowledge or its status as manufacturer of the Collaboration Product for clinical supply. Xencor’s costs in connection therewith shall be Development Costs. |
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5.3.2 The Parties shall support one another, as may be reasonably necessary or appropriate, in obtaining Regulatory Approval for the Collaboration Products, including providing necessary documents or other materials required by Applicable Law to obtain Regulatory Approvals, in each case in accordance with the terms and conditions of this Agreement and the GDP. |
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ARTICLE 6
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the Territory, and (e) manage all aspects of contracting with providers, distributors, managed care vendors or payers with respect to any Collaboration Product in the Territory. |
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6.4 Product Labeling; Markings and Co-Branding. Genentech shall own and be responsible for all Product Labeling for all Collaboration Products. |
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(b) As conditions precedent to exercising a Co-Promotion Option for a Co-Promotion Product and maintaining the right to Co-Promote such Co-Promotion Product, Xencor must: |
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(i) establish, by means of a presentation to Genentech as of the time of exercise, that it has (A) an internal sales management organization and infrastructure to conduct Xencor’s Co-Promotion activities for such Co-Promotion Product and (B) a plan to hire, retain, or otherwise build a sales force that will be in place no later than [***] prior to the anticipated First Commercial Sale of such Co-Promotion Product consisting of at least the number of sales representative that Xencor has elected to assume, comprised of direct employees of Xencor, each of whom has prior experience promoting pharmaceutical products to prescribing physicians in the Co-Promotion Territory. |
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6.6 Medical Affairs. Genentech shall have the sole right and responsibility to conduct and make decisions regarding Medical Affairs Activities with respect to any Collaboration Product. For clarity, Genentech shall retain such sole right and responsibility in the event that Xencor exercises its Co-Promotion Option. |
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(a) work with Genentech promptly following the Effective Date to identify the actions and assistance required of Xencor by Genentech and related timelines so as to enable Genentech to utilize the Xencor Initial Supply for the intended clinical trials of Collaboration Product; |
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(b) supply the requirements of the XmAb24306 Product for the Xencor Initial Supply to Genentech in accordance with the terms and conditions under this Agreement and the Supply Agreement; |
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(c) facilitate any requested inspections and audits by Genentech of the Xencor Approved CMOs (subject to the terms and conditions of any applicable agreements between Xencor and the Xencor Approved CMOs); and |
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(d) subject to applicable confidentiality obligations, provide Genentech with copies of all agreements between Xencor and the Xencor Approved CMOs under which the XmAb24306 Product is manufactured. |
The Parties shall execute, no later than [***] after the Effective Date, a supply agreement and related quality agreement for the Xencor Initial Supply (“Supply Agreement”), which will include customary and reasonable terms and conditions for clinical supply agreements in the industry (including a license grant, if necessary, to Xencor to perform its obligations, reasonable forecasting and ordering procedures to meet the timelines set forth in the GDP and consistent with Xencor’s existing agreements with the Xencor Approved CMOs, and remedies to address supply delays and failures); provided that any liabilities that would arise under the Supply Agreement shall be allocated between the Parties as set forth under this Agreement (including ARTICLE 14). The Parties acknowledge and agree that the Supply Agreement shall not conflict with this Agreement.
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Development Activity purposes. As provided in Section 7.2 below, the Parties shall cooperate so that the transfer of the Xencor Manufacturing Technology occurs in a timely manner in order to enable Genentech to Manufacture Collaboration Products. |
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enable Genentech to commence Manufacture of Collaboration Constructs and Collaboration Products, and thereafter to enable the Parties to undertake Manufacturing in the same manner, Xencor and Genentech shall use Commercially Reasonable Efforts to perform the technology transfers set forth below: |
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7.2.2 Following the initial transfer of Manufacturing Know-How pursuant to Section 7.2.1, as reasonably requested from time-to-time by Genentech, Xencor shall make available to Genentech, its Affiliates or CMOs a reasonable number of appropriately trained personnel to provide, on a mutually convenient timetable, technical assistance (both on site and otherwise) in the transfer and demonstration of the Manufacturing Know-How that has been transferred. The cost of providing this technical assistance to Genentech will be a Development Cost. |
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7.2.3 Each Party shall use Commercially Reasonable Efforts to enable Genentech to obtain all necessary Regulatory Approvals or modify existing Regulatory Approvals for the Manufacture by Genentech, its Affiliates or their CMOs of Collaboration Products for use by the Parties hereunder, including by reviewing and commenting on documents to be submitted by Genentech to a Regulatory Authority at Genentech’s reasonable request. For clarity, the cost incurred by the Parties in providing any such assistance described in this Section shall be Development Costs. |
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7.2.4 Xencor shall provide GNE with information with respect to the XmAb24306 Product and the materials used in its Manufacture to the extent reasonably necessary for registering Genentech’s selected facility for the XmAb24306 Product and to otherwise enable Genentech to expeditiously as possible commence the Manufacture of the XmAb24306 Product. |
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7.3 Commercial Supply. Genentech shall be solely responsible for the Manufacturing of Collaboration Products for commercial supply. |
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7.4 Manufacturing Costs and Related Costs. |
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7.4.1 Costs and expenses associated with the transfer of the Xencor Manufacturing Technology under Section 7.2 shall be borne by the Party incurring the expense, except for those costs specified as Development Costs in Sections 7.2.2 and 7.2.3. |
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(b) [***]Dollars ($[***]) upon the Initiation by or on behalf of Genentech of each of the [***] each Collaboration Product. |
For clarity, the milestone payments set forth in Section 8.2.1(a) shall only be paid once for each Collaboration Product that contains or comprises a Collaboration Construct that was Researched under a Research Plan.
For clarity, the milestone payments under Section 8.2.1(b) are payable [***] and up to [***] for each Collaboration Product.
In no event shall the cumulative amounts payable under Section 8.2.1(b) exceed one hundred sixty million Dollars ($160,000,000) per Collaboration Product.
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(a) Each Party shall report to the other Party, within [***] after the end of each Calendar Quarter, the Development Costs incurred by such Party during such Calendar Quarter. Such report shall specify in reasonable detail (including supporting documentation, as appropriate) all amounts included in such Development Costs during such Calendar Quarter (broken down by activity), and any FTE Costs and out-of-pocket costs shall be allocated to the extent possible to a specific activity in the GDP. The Parties shall seek to resolve any questions related to such reports within [***] following receipt by each Party of the other Party’s report hereunder. Following such resolution, Genentech shall prepare a reconciliation report for the Development Costs for such Calendar Quarter and shall either (a) deliver an invoice to Xencor for any amounts due to Genentech as a result of reconciliation or (b) notify Xencor that it should issue an invoice to Genentech, if the Development Costs incurred by Xencor for such Calendar Quarter exceed Xencor’s portion of the Collaboration Allocation of the total Development Costs incurred by the Parties. Payment by either Party shall be due [***] after receiving an invoice from the other Party based off the reconciliation report for the Development Costs for such Calendar Quarter. |
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(b) Each Party shall promptly notify the other Party in writing when it reasonably anticipates that the then-current GDP Budget will be exceeded in any Calendar Quarter by [***] percent ([***]%) or more. |
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(a) In the event that this Section 8.4 applies, each Party shall report to the other Party within [***] after the end of each Calendar Quarter commencing with the Calendar Quarter in which the First Commercial Sale in the Territory of a Collaboration Products occurs, with regard to the elements of the Net Profit/Net Loss calculation, including Net Sales (and the calculation thereof showing deductions taken with respect thereto) and Allowable Expenses incurred by such Party during such Calendar Quarter. Such report shall specify in reasonable detail all deductions allowed and taken in the calculation of Net Sales and all expenses included in Allowable Expenses. Within [***] after receipt of such reports, Genentech shall provide a consolidated financial statement setting forth the Net Profit or Net Loss for the Calendar Quarter. |
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The following remittances shall be paid within [***] after Genentech has provided the consolidated financial statement: |
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(ii) If there is a Net Loss for such Calendar Quarter, then the Party that has borne less than their share of the Allowable Expenses in excess of Net Sales in such Calendar Quarter shall make a reconciling payment to the other Party so that Xencor bears its portion of the Collaboration Allocation of such Allowable Expenses in excess of Net Sales and Genentech bears its portion of the Collaboration Allocation of of such Allowable Expenses in excess of Net Sales during such Calendar Quarter as described by the Settlement Amount Due in Exhibit D. |
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(b) Each Party shall promptly notify the other Party in writing when it reasonably anticipates that the then-current budget in the Commercialization Plan will be exceeded in any Calendar Quarter by [***] percent ([***]%) or more. |
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8.4.3 Collaboration Allocation Adjustment and Opt-Out Royalty Conversion From Net Profit / Net Loss. |
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8.4.3(b) (“Royalty Conversion”); provided, that, (i) Xencor shall not have the right to make a Royalty Conversion for a period of [***] following receipt of a milestone payment under Section 8.2.1(b), and (ii) the effective date of a Royalty Conversion shall not be earlier than [***]. Upon the date of such notice of a Royalty Conversion (“Royalty Conversion Notice”), the following terms shall apply: |
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(i) Genentech shall have the sole and exclusive rights to Develop any and all Collaboration Products, and all Development rights and licenses granted to Xencor in any and all Collaboration Products under this Agreement shall terminate accordingly, in all cases except with respect to Xencor Studies, which Xencor shall continue to have the right to conduct as and to the extent set forth in Section 4.6; |
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(ii) Genentech shall have the sole and exclusive rights to Commercialize any and all Collaboration Products and all Commercialization rights and licenses granted to Xencor in any and all Collaboration Products (including any and all Co-Promote Options with respect to such Collaboration Products) shall terminate, and if Xencor previously exercised a Co-Promotion Option with respect to a Collaboration Product, the Parties will cooperate to promptly transition to Genentech all of Xencor’s Co-Promotion activities with respect to such Collaboration Product, after which any Co-Promotion by Xencor with respect to such Collaboration Product shall immediately terminate; |
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(iii) the JCC, if established pursuant to Section 2.4, shall automatically be disbanded [***] (or such longer period as the Parties mutually agree) from the date of the Royalty Conversion Notice, and Section 2.7 shall apply; and |
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(v) Xencor shall instead receive, as its sole future financial consideration in connection with Collaboration Products, commercially reasonable royalty payments from Genentech on Net Sales of Royalty Products based on a royalty rate [***] The Parties shall negotiate such consideration in good faith for a minimum of [***] (or such longer period as otherwise mutually agreed by the Parties) following delivery of such notice. If the Parties are unable to agree on the consideration following such good faith negotiations, either Party may submit the dispute (including any disagreement over any unpaid milestones) to “baseball” style arbitration pursuant to Section 15.5. Once the consideration is determined, the Parties shall amend this Agreement to reflect the royalty rate, milestones (if any), related payment terms and conditions, and the effective date of the Royalty Conversion. |
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Xencor
[***]
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Genentech
[***]
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8.7.3 Each Party agrees to reasonably assist the other Party in claiming exemption from such deductions or withholdings under double taxation or any similar agreement or treaty from time to time in force and in minimizing the amount required to be so withheld or deducted. |
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8.7.5 To the extent the activities of the Parties under this Agreement result in the recognition of a partnership for non-U.S. Tax purposes, the Parties agree that any non-U.S. Tax imposed at the level of the partnership on its profit (not including Tax required to be withheld to satisfy a Party’s own income tax obligation) shall be allocated and borne by the Parties according to the partnership profit allocation under the respective applicable tax law. |
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8.12 Confidentiality. The receiving Party shall treat all information subject to review under this ARTICLE 8 in accordance with the confidentiality provisions of ARTICLE 11 and the Parties shall cause the Arbitrator to enter into a reasonably acceptable confidentiality agreement with the audited Party obligating such firm to retain all such financial information in confidence pursuant to such confidentiality agreement. |
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9.1.2 Xencor hereby grants to Genentech a non-exclusive license, sublicenseable as provided in Section 9.2, under the Xencor IP and Xencor’s rights in the Program IP to (i) make, use, and import Subsequent Targeted Collaboration Constructs and Subsequent Targeted Collaboration Products, alone or for use in combination with a Combination Agent, and (ii) sell and offer for sale Subsequent Targeted Collaboration Products, alone or for use in combination with a Combination Agent, in each case of (i) and (ii), in the Field in the Territory following the [***] after the Research Term. |
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9.2 Genentech Sublicense Rights. |
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9.2.1 Subject to Section 9.2.3 below, Genentech may exercise its rights and perform its obligations under this Agreement by itself or through the engagement of any of its Affiliates. |
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9.2.2 Genentech may sublicense the rights granted to it under Section 9.1 to one (1) or more Third Parties (including Chugai); provided, that, Genentech may not grant any Third Party the right to both Develop and Commercialize any Collaboration Product in the U.S. or the Major European Countries until the [***] of the First Commercial Sale of a Collaboration Product in each such country. Subject to Sections 9.2.3 and 9.7, Genentech may grant a limited sublicense to subcontractors engaged in accordance with Section 9.7 solely for the purpose of performing the subcontracted tasks and obligations. |
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9.3.1 Research and Development License. Genentech hereby grants to Xencor a royalty-free, non-exclusive, sublicenseable solely as provided in Section 9.4, non-transferable license under (i) the Genentech IP (other than the Excluded Patents), (ii) Program IP, and (iii) the Xencor IP (to the extent exclusively licensed to Genentech), in each case solely to perform Xencor’s obligations, or exercise Xencor’s rights, under this Agreement. |
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9.3.2 License for Co-Promotion Activities. During any period in which Xencor is engaging in Co-Promotion under this Agreement, Genentech agrees to grant and hereby grants Xencor a co-exclusive (with Genentech, its Affiliates and sublicensees) non-sublicenseable, non-transferable license under the Co-Promotion IP Rights, solely to perform Xencor’s obligations and exercise its rights under the Commercialization Plan and Co-Promotion Agreement. |
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9.4.1 Subject to Section 9.4.3 below, Xencor may exercise its rights and perform its obligations under this Agreement by itself or through the engagement of any of its Affiliates. |
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9.4.2 Subject to Sections 9.4.3 and 9.7, Xencor may grant a limited sublicense under the license granted to Xencor in Section 9.3.1 to subcontractors engaged in accordance with Section 9.7 solely for the purpose of performing the subcontracted tasks and obligations under this Agreement. |
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9.5 No Implied Licenses; Retained Rights. |
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9.5.1 Except as expressly set forth herein, neither Party shall acquire any license or other intellectual property interest, by implication or otherwise, under or to any trademarks, patents or patent applications, know-how, or other intellectual property rights owned or Controlled by the other Party. For clarity, an exclusive license granted to a Party under any particular patent rights or Know-How Controlled by the other Party shall confer exclusivity to the Party obtaining such license only to the extent the Party granting such license Controls the exclusive rights to such Patent Rights or Know-How. |
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9.5.2 Notwithstanding anything to the contrary in this Agreement, nothing in this Agreement shall require a Party to make available any particular intellectual property rights that are not necessary to perform a Parties’ obligations and exercise its rights under this Agreement with respect to IL-15 or a Research Target or Collaboration Construct or Combination Agent that was included in a mutually agreed Research Plan or GDP (i.e., a Research Plan or GDP approved without the exercise of a Party’s decision-making authority) and any such intellectual property rights are expressly excluded from the subject matter licensed under this Agreement. |
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(a) During the Term, Xencor shall not research, develop, manufacture or commercialize, or enable or facilitate any Third Party to research, develop, manufacture or commercialize, any Non-targeted Collaboration Constructs, Non-targeted Collaboration Products, Initial Targeted Collaboration Constructs, and Initial Targeted Collaboration Products other than pursuant to and in accordance with this Agreement. |
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(b) During the Research Term, Xencor shall not research, develop, manufacture or commercialize, or enable or facilitate any Third Party to research, develop, manufacture or commercialize, any construct that contains IL-15 and at least one Fv Domain that specifically binds to a Target, other than pursuant to and in accordance with this Agreement. |
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(c) During the Research Term and for [***] thereafter, Xencor shall not research, develop, manufacture or commercialize, or enable or facilitate any Third Party to research, develop, manufacture or commercialize, any construct that contains IL-15 and at least one Fv Domain that specifically binds to a Research Target, other than pursuant to and in accordance with this Agreement. |
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(e) During the Research Term and for [***] thereafter, GNE shall not research, develop, manufacture or commercialize, or enable or facilitate Genentech or its Affiliates (other than GNE) or any Third Party to research, develop, manufacture or commercialize, any construct that contains IL-15 and at least one Fv Domain that specifically binds to a Research Target, other than pursuant to and in accordance with this Agreement. |
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(g) Nothing in Sections 9.6.1(d), 9.6.1(e) or 9.6.1(f) shall limit in any way the Global Function’s ability to research, develop, manufacture, or commercialize [***], in each case that are not the subject of research, development, or manufacture utilizing any Xencor Confidential Information. [***] |
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[***]. |
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(h) Notwithstanding the foregoing or anything in this Agreement to the contrary, nothing herein shall prohibit either Party from conducting, at any time during the Term, internal research and preclinical development for benchmarking purposes on any constructs that are owned or controlled by a Third Party at the time of such research or preclinical development. |
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9.8.1 The Parties acknowledge that, during the Term, the Parties may determine that Research, Development, Manufacture or Commercialization of any Collaboration Constructs or Collaboration Products (alone or for use in combination with one or more Combination Agent(s)) may require or benefit from a license acquired or entered into after the Effective Date with respect to additional Patents or Know-How of Third Parties (a “Potential In-License”). [***] |
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[***] Notwithstanding the foregoing, if the other Party obtain rights under such Third Party license to the Third Party’s intellectual property or Know-How to Research, Development, Manufacture or Commercialize a Collaboration Construct or Collaboration Product, then any future payment to such Third Party pursuant to such license shall be considered an Allowable Expense. |
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9.8.2 If a Party does not approve a Potential In-License, then the other Party may proceed to enter into such Potential In-License, provided that (i) such Potential In-License will not be deemed to be a Collaboration In-License hereunder, (ii) the Patents and Know-How in-licensed under such Potential In-License will not be deemed Xencor Patents or Xencor Know-How (as applicable) or Genentech Patents or Genentech Know-How (as applicable) and will not be deemed “Controlled” for purposes of this Agreement, (iii) each Party will have the right to enter into such Potential In-License, but no payments thereunder shall be Third Party IP Payments, and (iv) the other Party is not afforded protections or benefits under this Agreement with respect to any Patents or Know-How obtained under such Potential In-License. |
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9.8.3 Neither Party will negotiate for or agree to economic terms in any such Potential In-License in a manner that (i) results in the fees, royalties, milestones or other remuneration payable thereunder with respect to the other Party being disproportionately higher than the amounts payable with respect to other (sub)licensees, or (ii) discriminates against the other Party versus Third Parties in connection with such Potential In-License, including by way of identity of the (sub)licensee or the field or territory available for (sub)license. |
Except as otherwise set forth under Sections 3.4 and 4.2.3, this Article 10 shall apply to all intellectual property in relation to this Agreement as set forth below:
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10.1 Disclosure of Inventions. Each Party shall promptly disclose to the other Party, [***] |
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[***]. |
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10.2.1 Xencor. As between the Parties, Xencor shall solely own (a) the Xencor IP (other than Program IP) and (b) Xencor Core Inventions; |
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10.2.2 Genentech. As between the Parties, Genentech shall solely own (a) the Genentech IP (other than Program IP) and (b) Genentech Core Inventions; and |
[***].
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10.3 Assignments. |
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10.3.1 Xencor. Xencor shall require all of its employees, contractors and agents, and any Third Parties working on its behalf under this Agreement (and their respective employees, contractors and agents), to assign to Xencor any Know-How and other intellectual property (together with all Patents and other intellectual property rights therein) developed, conceived, or reduced to practice by such employees, contractors or agents or Third Parties; provided, that, in the case of any such Third Parties, to the extent that an assignment of such intellectual property cannot be obtained, then licenses sufficient to enable the Development, Commercialization and Manufacturing of Collaboration Constructs and Collaboration Products hereunder shall satisfy the obligations of this Section 10.3.1. [***]. |
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10.3.2 Genentech. Genentech shall require all of its employees, contractors and agents, and any Affiliates and Third Parties working on its behalf under this Agreement (and their respective employees, contractors and agents), to assign to Genentech Know-How and other intellectual property (together with all Patents and other intellectual property rights |
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therein) developed, conceived, or reduced to practice by such employees, contractors or agents or Affiliates or Third Parties; provided, that, in the case of any such Third Parties, to the extent that an assignment of such intellectual property cannot be obtained, then licenses sufficient to enable the Development, Commercialization and Manufacturing of Collaboration Constructs and Collaboration Products hereunder shall satisfy the obligations of this Section 10.3.2. Genentech hereby assigns to Xencor any and all rights, title, or interest that Genentech may have in any Xencor Core Invention and [***]. |
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10.3.3 Cooperation. Xencor and Genentech shall reasonably cooperate with each other to effectuate ownership of any intellectual property rights as set forth in this Agreement, including, but not limited to, by executing and recording documents. |
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10.4.1 Xencor Controlled Prosecution and Maintenance. As between the Parties, Xencor shall, at its sole discretion and expense, have the right (but not the obligation) to Prosecute and Maintain Patents within the Xencor IP as follows: |
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(a) Xencor Patents (including Xencor Product Patents). [***] |
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(b) Xencor Fc Patents. [***] |
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10.4.2 Genentech Controlled Prosecution and Maintenance. As between the Parties, Genentech shall, at its sole discretion and expense, have the right (but not the obligation) to Prosecute and Maintain Patents within the Genentech IP and Program IP as follows: |
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(a) Genentech Patents (including Genentech Product Patents). [***] |
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(c) Patent Term Extensions. Notwithstanding the foregoing and as between Xencor and Genentech, [***]. |
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10.4.3 Review and Comment. |
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(a) Xencor Patents (including Xencor Product Patents). [***] |
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(b) Program Patents and Genentech Patents (including Genentech Product Patents). [***] |
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priority to such Patent). In such event, the other Party will, upon such abandoning Party’s reasonable request, consult with such abandoning Party, on the status of its Prosecution and Maintenance activities, and furnish such abandoning Party, copies of documents related to the Prosecution and Maintenance of such Patents. For clarity, this section does not apply to patent term extensions as set forth in Section 10.4.2(c). |
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10.4.5 Terminal Disclaimer Filing. The Parties understand and agree that the value of the patent term lost by the filing of a terminal disclaimer in the U.S. [***] |
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10.9.3 Xencor shall have the right but not the obligation to bring and control any legal action in connection with any [***] at its own expense as it reasonably determines appropriate. Genentech shall cooperate with Xencor in connection with any such legal action (as may be reasonably requested by Xencor and at Xencor’s expense), including, if necessary, by executing reasonably appropriate documents, cooperating in discovery and joining as a party to the action if required. [***]. |
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10.11 Attorney-Client Privilege; Common Interest. Neither Party is waiving, nor shall be deemed to have waived or diminished, any of its attorney work product protections, attorney-client privileges or similar protections and privileges or the like as a result of disclosing information pursuant to this Agreement or any of its Confidential Information (including Confidential Information related to pending or threatened litigation) to the receiving Party, regardless of whether the disclosing Party has asserted, or is or may be entitled to assert, such privileges and protections. The Parties: (i) share a common legal and commercial interest in such disclosure that is subject to such privileges and protections; (ii) are or may become joint defendants in proceedings to which the information covered by such protections and privileges relates; (iii) intend that such privileges and protections remain intact should either Party become subject to any actual or threatened proceeding to which the disclosing Party’s Confidential Information covered by such protections and privileges relates; and (iv) intend that after the Effective Date both the receiving Party and the disclosing Party shall have the right to assert such protections and privileges. |
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11.1 Duty of Confidence. During the term of this Agreement and for a period of [***] thereafter, subject to the other provisions of this ARTICLE 11: |
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(b) the receiving Party may only use any such Confidential Information and Program Confidential Information for the purposes of performing its obligations or exercising its rights under this Agreement, or as permitted under this Agreement (for example, pursuant to Section 10.2.3 (Ownership of Program IP); and |
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(c) the receiving Party may disclose Confidential Information of the other Party or Program Confidential Information to: (i) its Affiliates and sublicensees; and (ii) employees, directors, agents, contractors, consultants and advisers of the receiving Party and its Affiliates and sublicensees, in each case to the extent reasonably necessary for the purposes of, and for those matters undertaken pursuant to, performing its obligations or exercising its rights under this Agreement; provided that such Persons are bound by legally enforceable obligations to maintain the confidentiality of the Confidential Information or Program Confidential Information in a manner consistent with the confidentiality provisions of this Agreement. |
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(b) is in the public domain before its receipt from the disclosing Party, or thereafter enters the public domain through no fault of the receiving Party; |
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(c) is subsequently disclosed, without an obligation of confidentiality, to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or |
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(d) is developed by the receiving Party independently and without use of or reference to any Confidential Information received from the disclosing Party or Program Confidential Information, as documented by the receiving Party’s business records. |
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(e) such disclosure: (i) is with respect to particular terms of this Agreement that the receiving Party reasonably believes is necessary to fulfill its obligations or exercise its rights under this Agreement, or (ii) is to a bona fide actual or prospective acquirer, underwriter, investor, lender or other financing source or a bona fide actual or prospective collaborator, licensor, sublicensee, licensee or strategic partner or to an employee, director, agent, consultant and adviser of such Third Party, in each case who are under an obligation or confidentiality with respect to |
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such information that is no less stringent than the terms of this ARTICLE 11 but of duration customary in confidentiality agreements entered into for a similar purpose. |
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11.5 Terms of this Agreement. The Parties agree that this Agreement and the terms hereof will be considered Confidential Information of both Parties. |
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12.2 Publications. |
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12.2.1 [***]. |
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[***]. |
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12.2.3 Notwithstanding the foregoing, once a Publication has been approved by the non-publishing Party pursuant to Section 12.2.2, either Party may make subsequent public disclosure of the contents of such Publication without the further approval of the other Party; provided that, (i) such content is not presented with any new data or information or conclusions or in a form or manner that materially alters the subject matter therein, and (ii) the publishing Party shall provide a copy of such Publication to the other Party. |
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13.1 General Representations and Warranties. Xencor represents and warrants to GNE and Roche as of the Execution Date, and each of GNE and Roche represents and warrants to Xencor as of the Execution Date that: |
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13.1.1 it is validly organized under the laws of its jurisdiction of incorporation; |
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13.1.2 subject to Section 17.19, it has obtained all necessary consents, approvals and authorizations of all governmental authorities and other persons or entities required to be obtained by it in connection with this Agreement; |
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13.1.3 the execution, delivery and performance of this Agreement have been duly authorized by all necessary corporate action on its part; |
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13.1.4 it has the full right, power and authority to enter into this Agreement, and to fully perform its obligations hereunder; |
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13.1.5 this Agreement has been duly executed by it and is legally binding upon it, enforceable in accordance with its terms, and neither this Agreement nor performance of its obligations hereunder will conflict with any agreement, contract, instrument, understanding |
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or other arrangement, oral or written, to which it is a party or by which it may be bound, nor violate any material Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it; and |
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13.1.6 it follows reasonable commercial practices common in the industry to protect its proprietary and confidential information, including requiring its employees, consultants and agents to be bound in writing by obligations of confidentiality and non-disclosure, and requiring its employees, consultants and agents to assign to it any and all inventions and discoveries discovered by such employees, consultants or agents made within the scope of, and during their employment, and only disclosing proprietary and confidential information to Third Parties pursuant to written confidentiality and non-disclosure agreements |
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13.2 Representations and Warranties by Xencor. Xencor represents and warrants to Genentech as of the Execution Date, and covenants, as follows: |
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13.2.2 it has not received any written notice from any Third Party asserting or alleging that the development prior to the Execution Date of the XmAb24306 Product, or of any Targeted Collaboration Constructs or Non-Targeted Collaboration Constructs in existence as of the Execution Date infringed or misappropriated the intellectual property rights of such Third Party; |
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13.2.3 to its knowledge, no person is infringing or threatening to infringe or misappropriating or threatening to misappropriate the Xencor IP licensed to Genentech hereunder; |
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13.2.4 it does not have any constructs that contain IL-15, other than the XmAb24306 Product, and certain Non-targeted Collaboration Constructs and Targeted Collaboration Constructs as listed generally in Exhibit M and Exhibit N by reference to the applicable Targets (to the extent applicable); |
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13.2.5 there are no judgments or settlements against or owed by Xencor, and to Xencor’s knowledge, there are no pending or threatened claims, actions, litigation, or arbitration proceedings in each case relating in any way to any Xencor Technology that would adversely affect Genentech’s rights or licenses under this Agreement; and |
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13.2.6 the representations and warranties of Xencor in this Agreement, and the information, documents and materials furnished to Genentech in connection with its period of diligence prior to the Execution Date, do not, to its knowledge, and taken as a whole, (a) contain any untrue statement of a material fact or (b) omit to state any material fact necessary to make the statements or facts contained therein not misleading. |
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13.4 Mutual Covenants. |
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13.4.1 No Debarment. In the course of the Research of the Collaboration Constructs, and the Development and Commercialization of the Collaboration Products, neither Party (nor its Affiliates shall use any employee or consultant (including of any (sub)licensee)) who has been debarred or disqualified by any Regulatory Authority, or, to such Party’s or its Affiliates’ knowledge, is the subject of debarment or disqualification proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its or its Affiliates’ employees or consultants has been debarred or is the subject of debarment or disqualification proceedings by any Regulatory Authority. |
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13.4.2 Compliance. Each Party and its Affiliates shall comply in all material respects with all Applicable Laws (including all anti-bribery laws) in the exercise of its rights and performance of its obligations under this Agreement (including the Research of the Collaboration Constructs, and the Development and Commercialization of the Collaboration Products). |
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13.5 No Other Warranties. EXCEPT AS EXPRESSLY STATED IN THIS ARTICLE 13, (A) NO REPRESENTATION, CONDITION OR WARRANTY WHATSOEVER IS MADE OR GIVEN BY OR ON BEHALF OF Xencor OR GENENTECH; AND (B) ALL OTHER CONDITIONS AND WARRANTIES WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE ARE HEREBY EXPRESSLY EXCLUDED, INCLUDING ANY CONDITIONS AND WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT. |
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13.6 No Guarantee of Success. Except as otherwise specifically provided in this Agreement, neither of the Parties makes any representations or warranties, express, implied, statutory or otherwise, concerning the success or potential success of the Development or Commercialization of Collaboration Products. |
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(collectively, “Losses”) arising out of or in connection with any and all suits, investigations, claims or demands of Third Parties (collectively, “Claims”) against them arising or resulting from: |
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14.1.1 the negligence, recklessness or willful misconduct of Xencor or any of the Xencor Indemnitees; or |
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14.1.2 the breach of any of the warranties or representations made by Xencor to Genentech under this Agreement, the Pharmacovigilance Agreement, Supply Agreement or Co-Promotion Agreement; or |
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14.1.3 any breach by Xencor of its obligations pursuant to this Agreement, the Pharmacovigilance Agreement, Supply Agreement or Co-Promotion Agreement; or |
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14.1.4 Conduct of any Xencor Studies or related Development for Xencor Studies; or |
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14.1.5 Research conducted by Xencor (its Affiliates or sublicensees) outside a Research Plan; |
except in each case, for those Losses for which Genentech has an obligation to indemnify Xencor pursuant to Section 14.2 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
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14.2.1 the negligence, recklessness or willful misconduct of Genentech or any of the Genentech Indemnitees; or |
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14.2.2 the breach of any of the warranties or representations made by Genentech to Xencor under this Agreement, Pharmacovigilance Agreement, an applicable supply agreement or Co-Promotion Agreement; or |
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14.2.3 any breach by Genentech of its obligations pursuant to this Agreement, Pharmacovigilance Agreement, an applicable supply agreement or Co-Promotion Agreement; or |
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14.2.4 Development of a Collaboration Product for use in combination with an [***] Combination Agent Controlled by Genentech outside the GDP as permitted under Section 4.2.3; or |
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14.2.5 Commercialization of an [***] Combination Agent Controlled by Genentech for use in combination with a Collaboration Product; or |
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14.2.6 Research conducted by Genentech (its Affiliates or sublicensees) outside a Research Plan; or |
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14.2.7 Research, Development, Manufacture, and Commercialization of any Collaboration Product following the effective date of a Royalty Conversion; |
except in each case, for those Losses for which Xencor has an obligation to indemnify Genentech pursuant to Section 14.1 hereof, as to which Losses each Party shall indemnify the other to the extent of their respective liability for the Losses.
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14.5 Mitigation of Loss. Each Indemnified Party shall take and shall procure that its Affiliates take all such reasonable steps and action as are reasonably necessary or as the Indemnifying Party may reasonably require in order to mitigate any Losses arising out of or in connection with any Claims) under this ARTICLE 14. Nothing in this Agreement shall or shall be deemed to relieve any Party of any common law or other duty to mitigate any losses incurred by it. |
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14.7.1 Coverage. Each Party shall procure and maintain insurance coverage as set forth in this Section 14.7 at its own cost; provide however each Party has the right, in its sole discretion, to self-insure, in part or in whole, for any such coverage. |
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(b) Each Party shall maintain products liability insurance or clinical trial insurance as applicable, including contractual liability, combined single limit for bodily injury and property damage liability, in the minimum amount of: (A) [***] Dollars ($[***]) commencing at least [***] prior to any period during which a Party (or its sublicensees) is conducting a clinical trial with any Collaboration Product and (B) [***] Dollars ($[***]) commencing at least [***] prior to any period during which a Party (or its sublicensees) is Co-Promoting or selling any Collaboration Products. |
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(c) Each Party shall maintain (i) workers’ compensation insurance according to applicable law and (ii) employers’ liability insurance, in the minimum amount of [***] Dollars ($[***]). Each Party agrees to waive its right of subrogation with respect to any workers’ compensation claim. |
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14.7.2 Additional Requirements. Except to the extent that a Party self-insures, the following provisions shall apply: |
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(a) All insurance coverage shall be primary insurance with respect to each Party’s own participation under this Agreement and shall be maintained with an insurance company or companies having an A.M. Best’s rating (or its equivalent) of A‑XII. |
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(b) Each Party shall name the other Party as an additional insured under its CGL and Products Liability insurance policies. |
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(c) The insurance policies shall be under an occurrence form, but if only a claims‑made form is available to a Party, such Party shall maintain the insurance coverage for at least [***] after such Party completes performance of its obligations under this Agreement. |
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(d) On request, each Party shall provide to the other Party certificates of insurance evidencing the insurance coverage required under this Section 14.7. Each Party shall provide to the other Party at least [***] prior written notice of any cancellation, nonrenewal or material change in any of the required insurance coverages. |
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(e) The insurance coverage required pursuant to this Section 14.7 shall not be construed to create a limit of either Party’s liability with respect to its indemnification obligations under this ARTICLE 14. |
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(a) [***] days after the date of the notice if such notice is prior to Initiation of a Phase 1 Study for a relevant Collaboration Product hereunder; |
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(b) [***] after the date of notice if such notice is prior to Regulatory Approval but after Initiation of a Phase 1 Study of a relevant Collaboration Product hereunder; or |
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(c) [***] after the date of notice if such notice is after receipt of Regulatory Approval of a relevant Collaboration Product hereunder; provided, that, the Parties will each use their respective Commercially Reasonable Efforts to accomplish the activities described in Section 15.3 during such [***] period and, if accomplished, the Parties may agree in writing to an earlier effective date of termination. |
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proceeding, unless the bankrupt Party elects to continue to perform all of its obligations under this Agreement, or (ii) if not delivered under (i), immediately upon the rejection of this Agreement by or on behalf of the bankrupt Party. |
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15.2.4 Termination for Cessation. |
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(i) [***] have elapsed since the [***] Decision for such Collaboration Product ([***], if the Collaboration Product at issue is XmAb24306), |
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(ii) the projected aggregate spend by the Parties (whether or not such spend is shared by the Parties in accordance with Section 8.4) for the immediately preceding Calendar Year as of such date of the Cessation Notice for Research, Development and Commercialization activities (including Manufacturing activities) with respect to such Collaboration Product, alone or in combination with a Combination Agent, [***], |
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(iii) Xencor provided written notice to Genentech no later than three (3) months prior to the end of such Calendar Year of its reasonable anticipation of the [***] on such activities during such Calendar Year, |
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(iv) notwithstanding the notice provided by Xencor pursuant to Section 15.2.4(a)(iii), by the end of such Calendar Year, the [***] during such Calendar Year in conducting Research, Development and Commercialization activities (including Manufacturing activities) with respect to such Collaboration Product, |
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(v) the Parties’ failure to [***], and |
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(vi) Xencor has not previously provided Genentech a Cessation Notice with respect to the same Calendar Year. |
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(b) Within ten (10) Business Days of receipt of a Cessation Notice electing termination under this Section 15.2.4 (which notice must specifically reference this Section 15.2.4 and the Collaboration Product that Xencor is seeking to terminate), if Genentech believes that one or more of the requirements set forth in Section 15.2.4(a) above has not been met, then Genentech may challenge the validity of Xencor’s Cessation Notice by providing written notice to Xencor. Within five (5) Business Days of Genentech’s challenge, the JDC shall determine whether all of the requirements set forth in Section 15.2.4(a) have indeed been met, and if the JDC determines they have not all been met, Xencor’s election to terminate shall be void and have no effect (subject |
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to, and without limiting, the following sentence). Xencor may challenge the JDC’s findings in such a challenge pursuant to Expedited Dispute Resolution Procedure set forth in Exhibit J. |
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(c) If Xencor’s Cessation Notice is not challenged by Genentech, or if the JDC following such challenge finds that all of the requirements set forth in Section 15.2.4(a) have been met, or if the result of the Expedited Dispute Resolution Procedure set forth in Exhibit J is a determination that all of the requirements set forth in Section 15.2.4(a) have been met, then this Agreement shall terminate with respect to the Collaboration Product effective following the tenth (10th) Business Day after receipt of such Cessation Notice identified in Xencor’s notice of election and such Collaboration Product shall thereafter be a Termination Product hereunder. |
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(d) Notwithstanding the foregoing, within [***] of the receipt of a Cessation Notice with respect to a particular Collaboration Product, Genentech may elect to retain control of such Collaboration Product [***] following the date of such Cessation Notice by notifying Xencor in writing of its intent to do so within such [***] period and [***] no more than thirty (30) days after delivery of such notice. If Genentech so elects to retain control of such Collaboration Product, Xencor shall not have the right to terminate the Agreement with respect to such Collaboration Product pursuant to this Section 15.2.4 during such [***]. [***], Xencor shall have the right to terminate the Agreement with respect to such Collaboration Product pursuant to this Section 15.2.4 to the extent the requirements set forth in Section 15.2.4 have been satisfied. |
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15.3.2 Continuation of Genentech’s Sublicenses. Upon termination by Xencor of this Agreement, in its entirety, or with respect to Termination Subject Matter, under Section 15.2.2 or 15.2.3, any existing sublicense (other than to an Affiliate) granted by Genentech under this Agreement, in its entirety, or with respect to Termination Subject Matter, as applicable, shall continue in full force and effect, provided that the sublicensee (a) is not in breach of this Agreement (including not causing the breach that gave rise to a termination under Section 15.2.2), and (b) agrees in writing to be bound by all the terms and conditions of this Agreement that are applicable to such sublicensee, including rendering directly to Xencor all payments and other obligations due to Xencor related to such sublicense; provided further that (i) the scope of any such surviving sublicense, or any surviving rights for sublicensee under such sublicense, are not broader than (1) the rights granted by Xencor to Genentech under this Agreement, or (2) the rights granted by Genentech to such sublicensee under sublicense agreement between such sublicensee and Genentech and (ii) Xencor is not obligated to assume any obligations under such sublicense that are greater than the obligations contained within this Agreement. |
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15.3.3 Accrued Rights and Obligations. Expiration or termination of this Agreement in its entirety, or with respect to Termination Subject Matter, for any reason shall not release either Party hereto from any liability which, as of the effective date of such expiration or termination, had already accrued to the other Party or which is attributable to a period prior to such termination, nor preclude either Party from pursuing any rights and remedies it may have hereunder or at law or in equity which accrued or are based upon any event occurring prior to the effective date of such expiration or termination. |
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15.3.4 Destruction of Confidential Information. It is understood and agreed, that each receiving Party shall have a continuing right to use Confidential Information of the disclosing Party and Program Confidential Information under any surviving licenses pursuant to this ARTICLE 15. Subject to the foregoing, following expiration or any early termination of this Agreement, in its entirety, the receiving Party shall destroy (at the disclosing Party’s written request) all, Confidential Information of the disclosing Party in its possession as of the effective date of expiration (with the exception of one copy of such Confidential Information, which may be retained by the receiving Party to confirm compliance with the non‑use and non‑disclosure provisions of this Agreement), and any applicable Confidential Information of the disclosing Party contained in its laboratory notebooks or databases, provided that the receiving Party may retain and continue to use the applicable disclosing Party’s Confidential Information to the extent necessary to exercise any surviving rights, licenses or obligations under this Agreement. |
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15.3.6 Inventory at Termination. In the event that the licenses under ARTICLE 9 terminate with respect to a particular Collaboration Product, Genentech, its Affiliates and its sublicensees shall have, [***] following such termination, the right to sell or otherwise dispose of all inventory of such Collaboration Products in all countries then in its stock, subject to Section 8.4 of this Agreement, and any other applicable provisions of this Agreement, and Xencor covenants not to xxx Genentech or its Affiliates or sublicensees for infringement under any of the Patents that were licensed from Xencor to Genentech under this Agreement immediately prior to such termination with respect to such activities conducted by Genentech or its Affiliates or sublicensees pursuant to this Section 15.3.6. |
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(a) Genentech shall, [***] following the effective date of the applicable termination, provide copies to Xencor of (i) [***] and (ii) [***] ((i) and (ii) collectively, the “Data Package”); |
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(b) Xencor shall have the right, following delivery of the Data Package from Genentech to Xencor, for [***] to negotiate in good faith with Genentech the terms (the “Transfer Agreement”) under which (i) Genentech will transition to Xencor the activities relating to the Termination Product (e.g., transitioning of any ongoing Clinical Studies) (ii) [***]; and (iii) [***]; provided, that, Xencor may provide notice to Genentech that Xencor does not desire to continue any one or more of such activities, in which case Genentech will be responsible for winding-down any such activities that Xencor does not desire to assume in accordance with Applicable Laws and industry standards. If the Parties are unable to agree on the terms of the Transfer Agreement within such period, Xencor may submit such dispute to baseball style arbitration for resolution as provided in Section 15.5 below; |
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to the foregoing license grant that specifically and intentionally binds to the same Research Target as any Collaboration Construct or Collaboration Product in Research or Development pursuant to this Agreement until such time as such Research Target is no longer being Researched or Developed under this Agreement by or on behalf of Genentech, its Affiliates or sublicensees; and |
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(d) Genentech shall continue to be responsible for funding (and shall continue to receive, as applicable) its portion of the Development Costs and share in the Net Profit and Net Loss in accordance with the Collaboration Allocation pursuant to Section 8.4 with respect to such Termination Product (based on the GDP and Commercialization Plan for such Termination Product as of the date of notice of such termination) for a period of [***] following the effective date of such termination. For a period of [***] following the effective date of termination of this Agreement the Parties shall continue to be responsible for their respective portion of the Collaboration Allocation (based on the GDP and Commercialization Plan as of the date of notice of termination) pursuant to Section 8.4. |
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15.3.8 Survival. Except as expressly set forth under this Article 15, upon the expiration or termination of this Agreement in its entirety or with respect to a particular Termination Subject Matter, all rights and obligations of the Parties under this Agreement shall terminate in its entirety or with respect to such Termination Subject Matter, as applicable. In addition to any provisions specified in this Agreement as surviving under the applicable circumstances, the following provisions shall survive expiration or termination of this Agreement in accordance with the terms therein: [***] |
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thereafter. Each Party will use commercially reasonable efforts to effect the manufacturing transfer to the Authorized CDMO as quickly as possible. |
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15.5.1 The applicable Party shall notify the other Party of its decision to initiate the arbitration proceeding pursuant to this Section 15.5 through written notice to such other Party; |
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15.5.2 Within ten (10) days following the receiving Party’s receipt of such notice, each Party shall select one (1) arbitrator, and the two (2) arbitrators so selected shall choose a third arbitrator. All three (3) arbitrators shall serve as neutrals and have at least ten (10) years of (i) dispute resolution experience (which may include judicial experience) or (ii) legal or business experience in the biotech or pharmaceutical industry. In any event, at least one (1) arbitrator shall satisfy the foregoing experience requirement under clause (ii). If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot agree on the third arbitrator, the necessary appointment shall be made in accordance with the Rules. Once appointed by a Party, such Party shall have no ex parte communication with its appointed arbitrator; |
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15.5.3 Within ten (10) days of its appointment, the panel shall set a date for the arbitration, which date shall be no more than sixty (60) days after the date the arbitration is demanded under Section 15.5.1; |
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15.5.4 The arbitration shall be “baseball-style” arbitration; accordingly, at least fourteen (14) days prior to the arbitration, each Party shall provide the panel with a written agreement on the terms of the Transfer Agreement (or, if the dispute relates to other financial terms in this Agreement, then those financial and related terms) suggested by such Party. Such written agreement may be no more than one hundred (100) pages, and must clearly provide and identify the Party’s position with respect to the disputed matter; |
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15.5.5 After receiving both Parties’ written agreements, the panel will distribute each Party’s written agreement to the other Party. Seven (7) days in advance of the arbitration, the Parties shall submit and exchange response briefs of no more than fifteen (15) pages. The Parties’ briefs may include or attach relevant exhibits in the form of documentary evidence, any other material voluntarily disclosed to the other Party in advance, or publicly available information. The Parties’ briefs may also include or attach demonstratives or expert opinion based on the permitted documentary evidence; |
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15.5.6 The arbitration shall consist of a one (1) day hearing of no longer than eight (8) hours, such time to be split equally between the Parties, in the form of presentations by counsel or employees and officers of the Parties. No live witnesses shall be permitted except expert witnesses whose opinions were provided with the Parties’ briefs; |
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15.5.7 No later than fifteen (15) days following the arbitration, the panel shall issue its written decision. The panel shall select one Party’s written agreement as its decision, and shall not have the authority to render any substantive decision other than to select the written |
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agreement submitted by either Genentech or Xencor. The panel shall have no discretion or authority with respect to modifying the positions of the Parties. The panel’s decision shall be final and binding on the Parties and the written agreement selected by the panel shall constitute a binding agreement between the Parties that may be enforced in accordance with its terms. Each Party shall bear its own costs and expenses in connection with such arbitration, and shall share equally the panel’s fees and expenses; |
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15.5.8 The violation of one of the time limits prescribed in this Section 15.5 by the panel shall not affect the panel’s competence to decide on the subject matter, and shall not affect the final and binding decision rendered by the panel, unless otherwise agreed by the Parties; and |
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15.5.9 The above “baseball-style” arbitration shall be the exclusive remedy of either Party if the Parties cannot agree on the agree on the terms of the Transfer Agreement, or the various financial terms that are subject to resolution in accordance with this Section 15.5. |
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15.6 Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected and notwithstanding anything contained in this Agreement to the contrary, all other remedies shall remain available except as agreed to otherwise herein. |
For Genentech – [***]
For Xencor – [***]
In the event the designated officers, or their respective designees, are not able to resolve such dispute within [***] of such other Party’s receipt of such written notice, either Party may initiate the dispute resolution procedures set forth in Section 16.2. The Parties agree that any discussions between such executives (or their designees) regarding such Dispute do not constitute settlement discussions, unless the Parties agree otherwise in writing; provided that the Parties agree any such Dispute and related discussions shall be treated as Confidential Information of both Parties under this Agreement.
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Notwithstanding the foregoing, Disputes shall not include any disagreements solely about decisions for which one Party has final decision-making authority under this Agreement, including under ARTICLE 2.
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16.2.2 Arbitrators; Location. Each Party shall select one (1) arbitrator, and the two (2) arbitrators so selected shall choose a third arbitrator. All three (3) arbitrators shall serve as neutrals and have at least ten (10) years of (i) dispute resolution experience (which may include judicial experience) or (ii) legal or business experience in the biotech or pharmaceutical industry. In any event, at least one (1) arbitrator shall satisfy the foregoing experience requirement under clause (ii). If a Party fails to nominate its arbitrator, or if the Parties’ arbitrators cannot agree on the third arbitrator, the necessary appointments shall be made in accordance with the Rules. Once appointed by a Party, such Party shall have no ex parte communication with its appointed arbitrator. The arbitration proceedings shall be conducted in San Francisco, California. |
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16.2.3 Procedures; Awards. Each Party agrees to use reasonable efforts to make all of its current employees available, if reasonably needed, and agrees that the arbitrators may deem any party as “necessary.” The arbitrators shall be instructed and required to render a written, binding, non‑appealable resolution and award on each issue that clearly states the basis upon which such resolution and award is made. The written resolution and award shall be delivered to the Parties as expeditiously as possible, but in no event more than [***] after conclusion of the hearing, unless otherwise agreed by the Parties. Judgment upon such award may be entered in any competent court or application may be made to any competent court for judicial acceptance of such an award and order for enforcement. Each Party agrees that, notwithstanding any provision of applicable law or of this Agreement, it will not request, and the arbitrators shall have no authority to award, punitive or exemplary damages against any Party. |
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16.2.4 Costs. The “prevailing” Party, as determined by the arbitrators, shall be entitled to (a) its share of fees and expenses of the arbitrators and (b) its attorneys’ fees and associated costs and expenses. In determining which Party “prevailed,” the arbitrators shall consider (i) the significance, including the financial impact, of the claims prevailed upon and (ii) the scope of claims prevailed upon, in comparison to the total scope of the claims at issue. If the arbitrators determine that, given the scope of the arbitration, neither Party “prevailed,” the arbitrators shall order that the Parties (1) share equally the fees and expenses of the arbitrators and (2) bear their own attorneys’ fees and associated costs and expenses. |
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16.2.5 Interim Equitable Relief. Notwithstanding anything to the contrary in Section 16.2, in the event that a Party reasonably requires relief on a more expedited basis than would be possible pursuant to the procedure set forth in ARTICLE 16, such Party may seek a temporary injunction or other interim equitable relief in a court of competent jurisdiction pending the opportunity of the arbitrators to review the decision under Section 16.2. Such court shall have no jurisdiction or ability to resolve Disputes beyond the specific issue of temporary injunction or other interim equitable relief. |
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16.2.6 Protective Orders; Arbitrability. At the request of either Party, the arbitrators shall enter an appropriate protective order to maintain the confidentiality of information produced or exchanged in the course of the arbitration proceedings. The arbitrators shall have the power to decide all questions of arbitrability. |
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part to an Affiliate of such Party, or (b) in whole to its successor-in-interest in connection with the sale of all or substantially all of its stock or its assets to which this Agreement relates, or in connection with a merger, acquisition or similar transaction (a “Sale Transaction”); provided that the assigning Party shall promptly provide written notice to the other Party of any such assignment. Any attempted assignment not in accordance with this Section 17.2 shall be null and void and of no legal effect. Any permitted assignee shall assume all assigned obligations of its assignor under this Agreement. The terms and conditions of this Agreement shall be binding upon, and shall inure to the benefit of, the Parties and their respected successors and permitted assigns. Notwithstanding anything to the contrary in this Agreement, in the event of a Sale Transaction whereby a Party is acquired (including in connection with a Change in Control), (i) the intellectual property rights of the acquiring party in such a Sale Transaction (together with any entities that were affiliates of such Third Party immediately prior to such acquisition) shall not be included in the intellectual property licensed hereunder or otherwise subject to this Agreement, and (ii) the acquiring party in such a Sale Transaction or a Change in Control (together with any entities that were affiliates of such Third Party immediately prior to such acquisition) shall not be subject to Section 9.6 so long as the acquired Party and the acquiring party both promptly adopt and implement written firewall procedures ensuring that the acquiring party and individuals working on the acquiring party’s programs will have no access under this Agreement to the Research Plan, the GDP, any information received by the acquired Party pursuant to ARTICLE 2 or the Committees or Joint Project Teams established thereunder, ARTICLE 5, ARTICLE 6, or ARTICLE 7, any Program IP, any intellectual property rights licensed or arising under this Agreement, any Program Confidential Information, or any Confidential Information of the other Party. |
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17.3 Severability. If any one or more of the provisions contained in this Agreement is held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the absence of the invalidated provision(s) adversely affects the substantive rights of the Parties. The Parties shall in such an instance use their best efforts to replace the invalid, illegal or unenforceable provision(s) with valid, legal and enforceable provision(s) which, insofar as practical, implement the purposes of this Agreement. |
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17.4 Notices. All notices which are required or permitted hereunder shall be in writing, shall specifically refer to this Agreement, and shall be sufficient if delivered personally, sent by facsimile (or a PDF image delivered by email) (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows: |
If to Xencor:
Xencor, Inc.
000 Xxxx Xxxxx Xxxxxx, 0xx Xxxxx
Xxxxxxxx, XX 00000
Attn:Chief Executive Officer
[***]
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If to Genentech:
Genentech, Inc.
[***]
with a copy to (which shall not constitute notice):
Genentech, Inc.
[***]
If to Roche:
X. Xxxxxxxx-Xx Xxxxx Ltd
c/o Genentech, Inc.
[***]
with a copy to (which shall not constitute notice):
X. Xxxxxxxx-Xx Xxxxx Ltd
[***]
or to such other address(es) as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith. For clarity, notice to Genentech shall require notice to both GNE and Roche. Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile (or a PDF image delivered by email) on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day); (b) on the Business Day after dispatch if sent by nationally-recognized overnight courier; or (c) on the fifth (5th) Business Day following the date of mailing, if sent by mail.
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17.5 Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of California and the patent laws of the United States without reference to any rules of conflict of laws. The Parties hereby exclude from this Agreement the application of the United Nations Convention on Contracts for the International Sale of Goods. |
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17.6 Entire Agreement; Amendments. This Agreement, together with the Exhibits hereto, contains the entire understanding of the Parties with respect to the collaboration and the licenses granted hereunder. Any other express or implied agreements and understandings, negotiations, writings and commitments, either oral or written, in respect to the collaboration and the licenses granted hereunder are superseded by the terms of this Agreement. The Exhibits to this Agreement are incorporated herein by reference and shall be deemed a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by authorized representative(s) of each Party. The Parties agree that, effective as of the Effective Date, that the Mutual Confidentiality Agreement, effective as of May 18, 2018, by and between GNE and Xencor shall be superseded by this Agreement, and that disclosures made prior to the Effective Date pursuant to the Confidentiality Agreement shall be subject to the confidentiality and non-use provisions of this Agreement. The foregoing shall not be interpreted as a waiver of any remedies available to either Party or its Affiliates as a result of any breach, prior to the Effective Date, by the other Party or its Affiliates of such Party’s or its Affiliate’s obligations pursuant to the Confidentiality Agreement. |
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17.7 Headings. The captions to the several Articles, Sections and subsections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof. |
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17.9 Waiver. The waiver by either Party hereto of any right hereunder, or of any failure of the other Party to perform, or of any breach by the other Party, shall not be deemed a waiver of any other right hereunder or of any other breach by or failure of such other Party whether of a similar nature or otherwise. |
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17.10 Cumulative Remedies. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Law. |
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17.11 No Third Party Rights. The Parties do not intend that any term of this Agreement should be enforceable by any person or entity who is not a Party. |
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17.14 Business Day Requirements. In the event that any notice or other action or omission is required to be taken by a Party under this Agreement on a day that is not a Business Day then such notice or other action or omission shall be deemed to be required to be taken on the next occurring Business Day. |
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17.16 Actions of Affiliates. Genentech may exercise its rights or perform its obligations under this Agreement personally or through one or more Affiliates, provided that Genentech shall nonetheless be primarily liable for the performance of its Affiliates and for any failure by its Affiliates to comply with the restrictions, limitations and obligations set forth in this Agreement. Further, each of GNE and Roche will be jointly and severally liable for any performance or non-performance of Genentech hereunder, and each of GNE and Roche hereby expressly waive any requirement that Xencor exhaust any right, power or remedy, or proceed against either GNE or Roche in particular, for any obligation or performance of Genentech hereunder prior to proceeding directly against either or both of GNE or Roche. |
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17.17 Further Actions. Each Party agrees to execute, acknowledge and deliver such further instruments, and to do all such other acts, as necessary or appropriate in order to carry out the purposes and intent of this Agreement. |
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17.18 Counterparts. This Agreement may be executed in two or more counterparts by original signature, facsimile or PDF files, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. |
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[Signature page follows – the rest of this page intentionally left blank.]
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IN WITNESS WHEREOF, each of Xencor, Genentech and Roche, intending to be bound have caused this Agreement to be executed by their duly authorized representatives as of the Execution Date.
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Xencor, Inc. By:/s/ Bassil Dahiyat
Name:Bassil Dahiyat
Title:President and Chief Executive Officer
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Genentech, Inc. By:/s/ Xxxxxx Xxxxxxxxxx
Name:Xxxxxx Xxxxxxxxxx
Title:Chief Financial Officer
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X. Xxxxxxxx-Xx Xxxxx Ltd By: /s/ Xxxxxx Xxxxxx Name: Xxxxxx Xxxxxx Title: Head Legal Pharma and By: /s/ Xxxxxxx Xxxxxxxxx Name: Xxxxxxx Xxxxxxxxx Title: Legal Counsel
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Exhibit A
Initial Research Plan
[***]
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o |
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[***]
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Exhibit B
Initial Research Plan
[***]
[***]
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Exhibit C
Key Terms of Co-Promotion Agreement
[***]
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1. |
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[***]
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i. |
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[***]
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Exhibit D
Example Quarterly Net Profit/Net Loss Calculation
[***]
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Exhibit E
Xencor to Develop and Commercialize Novel IL-15 Immune Activating Cytokines with Genentech
-- Xencor Receives $120 Million Upfront Payment, up to $180 Million in Development Milestones Per Program and Profit Share from Commercialized Medicines --
MONROVIA, Calif., February 1, 2019 – Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic disease, and cancer, today announced it has entered into a research and license agreement with Genentech, a member of the Roche Group, to develop and commercialize novel IL-15 cytokine therapeutics, including XmAb®24306. XmAb24306 is an IL-15/IL-15Rα cytokine complex engineered with Xencor’s bispecific Fc domain and Xtend™ Fc technology and is Xencor’s most advanced preclinical cytokine program.
“This partnership with Genentech accelerates our immuno-oncology work by enabling the exploration of novel XmAb24306 combinations with Genentech’s leading oncology portfolio and our growing internal pipeline of bispecific antibodies,” said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. “A wide-ranging combination strategy will be critical to realize the potential of IL-15 bispecific cytokines such as XmAb24306, so we plan to explore our cytokines with a broad spectrum of leading commercial-stage and investigational cancer therapies.”
“We believe cytokine therapy will play an important role in the treatment of a wide range of diseases, including cancer,” said Xxxxx Xxxxx, M.D., Ph.D., global head of Pharma Partnering, Roche. “This collaboration with Xencor will further enhance our understanding of a critical immune activation pathway and may present a potential new way to use the immune system to target cancer.”
IL-15 is a highly active cytokine, or immune signaling protein, that when pre-complexed with IL-15 receptor alpha (IL-15Rα) will bind to IL-15Rβγ and stimulate the expansion and activation of natural killer (NK) cells and cytotoxic T cells, but with reduced regulatory T cell activation compared to IL-2. Xencor’s IL-15 bispecific cytokine platform provides a more druggable version of IL-15 with potentially superior tolerability, slower receptor-mediated clearance and a prolonged half-life, and is intended for development with a wide range of combination agents due to its proposed mechanism of activating tumor-killing immune cells.
Under the terms of the agreement, the companies will co-develop XmAb24306 and other potential IL-15 programs, in which the companies will share development costs and profits. Genentech will commercialize medicines worldwide, and Xencor has the option to co-promote in the United States. Additionally, the companies will engage in a two-year research program to discover new IL-15 drug candidates, including ones targeted to specific immune cell populations. Genentech will pay Xencor $120 million upfront, and Xencor will be eligible to receive up to $160 million in development milestones for the XmAb24306 program and up to $180 million in development milestones for each new IL-15 drug candidate.
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The agreement is subject to customary closing conditions, including clearance under the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act, and closing is expected to occur in the first half of 2019.
About Xencor, Inc.
Xencor is a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases and cancer. Currently, 12 candidates engineered with Xencor’s XmAb® technology are in clinical development internally and with partners. Xencor’s internal programs include: obexelimab (XmAb®5871) in Phase 2 development for the treatment of IgG4-related disease, and also for the treatment of systemic lupus erythematosus; XmAb®7195 in Phase 1 development for the treatment of asthma and allergic diseases; XmAb®14045 in Phase 1 development for acute myeloid leukemia; XmAb®13676 in Phase 1 development for B-cell malignancies; XmAb®18087 in Phase 1 development for the treatment of neuroendocrine tumors and gastrointestinal stromal tumors; XmAb®20717 in Phase 1 development for the treatment of advanced solid tumors, and XmAb®22841, XmAb®23104 and XmAb®24306 in preclinical development for the treatment of multiple cancers. Xencor’s XmAb antibody engineering technology enables small changes to the structure of monoclonal antibodies resulting in new mechanisms of therapeutic action. Xencor partners include Novartis, Amgen, MorphoSys, CSL, Alexion and Boehringer Ingelheim. For more information, please visit xxx.xxxxxx.xxx.
Xencor Forward Looking Statement
Statements contained in this press release regarding matters that are not historical facts are forward-looking statements within the meaning of applicable securities laws, including, but not limited to, the quotations from Xencor’s president and chief executive officer and any expectations relating to Xencor’s financial expectations and business, the timing and success of clinical trials, future product candidates, Xencor’s research and development programs, partnering efforts and capital requirements. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements and the timing of events to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. Such risks include, without limitation, the risks associated with the process of discovering, developing, manufacturing and commercializing drugs that are safe and effective for use as human therapeutics and other risks described in Xencor’s public securities filings. For a discussion of these and other factors, please refer to Xencor’s annual report on Form 10-K for the year ended December 31, 2017 as well as Xencor’s subsequent filings with the Securities and Exchange Commission. All forward-looking statements are based on Xencor’s current information and belief as well as assumptions made by Xencor. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Xencor undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
Contacts
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For Xencor: Xxxxxxx Xxxxx, Tel: 000-000-0000, xxxxxx@xxxxxx.xxx; Media Contact: Xxxxx X. Spark, Xxxxxx Communications, Tel: 000-000-0000, xxxxx@xxxxxxxxxx.xxx
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Exhibit F
[***]
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[***]
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Exhibit G
Excluded Patents
[***]
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Exhibit H
Xencor Manufacturing Technology
[***]
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Exhibit I
Program Materials and Technology
[***]
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[***]
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Exhibit J
EXPEDITED DISPUTE RESOLUTION PROCEDURE
[***]
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Exhibit K
[***]
[***]
[***]
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Exhibit L
Excluded Targets
[***]
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Exhibit M
Non-targeted Collaboration Constructs
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[***]
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Exhibit N
Targeted Collaboration Constructs
[***]
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[***]
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[***]
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[***]
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