COLLABORATION, OPTION AND LICENSE AGREEMENT Between
EXECUTION VERSION
COLLABORATION, OPTION AND LICENSE AGREEMENT
Between
GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4) LIMITED
And
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
COLLABORATION, OPTION AND LICENSE AGREEMENT
This Collaboration, Option and License Agreement (the “Agreement”) is made and entered into as of June 15, 2020 (“Execution Date”) and is effective as of the Effective Date (as defined below), between GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4) LIMITED (“GSK”), and IDEAYA Biosciences, Inc., a Delaware corporation having an office at 0000 Xxxxxxxxx Xxxxx, Xxxxx 000, Xxxxx Xxx Xxxxxxxxx, XX 00000 (“IDEAYA”). GSK and IDEAYA are sometimes referred to individually as a “Party” and collectively as the “Parties.”
BACKGROUND
WHEREAS, GSK, among other things, conducts programs to discover, develop, manufacture and commercialize innovative pharmaceutical medicines;
WHEREAS, IDEAYA, among other things, conducts programs to discover and develop therapeutic products for the treatment and prevention of diseases;
WHEREAS, GSK and IDEAYA desire to enter into this Agreement to collaborate with respect to three (3) Collaboration Programs, consistent with the terms and conditions set forth herein; and
WHEREAS, IDEAYA wishes to grant, and GSK wishes to accept the Option and licenses set forth herein.
NOW, THEREFORE, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties agree as follows:
Capitalized terms used in this Agreement, whether used in the singular or plural, shall have the meanings set forth below, unless otherwise specifically indicated herein.
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
legal entity, or status as a general partner in the case of any partnership, or any other arrangement whereby a corporation or other entity controls or has the right to control the board of directors or equivalent governing body or management of another corporation or other entity. |
1.3 |
“Aggregate Purchase Price” has the meaning set forth in the Purchase Agreement. |
1.4 |
“Agreement” has the meaning set forth in the preamble. |
1.5 |
“Alliance Manager” has the meaning set forth in Section 5.9. |
1.6 |
“Allowable Expenses” has the meaning set forth in the Pre-Tax Profit or Loss Schedule. |
1.7 |
“Applicable Law” means, individually and collectively, any and all laws, ordinances, rules, directives and regulations of any kind whatsoever of any governmental or regulatory authority within the applicable jurisdiction. |
1.8 |
“Arising Technology” means all Patents and Know-How invented, discovered, created or developed by or on behalf of a Party solely or the Parties jointly in connection with the exercise of its or their rights or performance of its or their obligations under this Agreement. |
1.9 |
“Balancing Payment” has the meaning set forth in Schedule 7.4.1. |
1.10 |
“Bankruptcy Code” means Title 11 of the United States Code. |
1.11 |
“Beneficial Ownership Limitation” has the meaning set forth in Section 7.1.2. |
1.12 |
“Big Four Accounting Firm” means one of the following: (i) Deloitte, (ii) Ernst & Young, (iii) KPMG, or (iv) PricewaterhouseCoopers. |
1.14 |
“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31. |
1.15 |
“Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.16 |
“CDA” means that certain Mutual Confidential Disclosure Agreement between GlaxoSmithKline LLC and IDEAYA effective June 4, 2019, as amended on April 23, 2020. |
1.18 |
“Clinical Dose Expansion” means the first person dosed in an expansion cohort of the applicable Phase 1 Clinical Study for the relevant Licensed Product being conducted by a Party utilizing the recommended dose for expansion for such Licensed Product. |
1.19 |
“Closing Date” has the meaning set forth in the Purchase Agreement. |
1.20 |
“Co-Chair” has the meaning set forth in Section 5.7.1. |
1.21 |
“Collaboration Budget” means the budget for conducting the corresponding Collaboration Plan as agreed by the Parties and approved by the applicable JDC and the JSC, as updated from time to time. |
1.22 |
“Collaboration Plan” means a plan for each Collaboration Program, setting out the preclinical Development activities (and solely with respect to the MAT2A Program, the limited clinical Development activities) to be conducted by or on behalf of the Parties, including the Party responsible for each activity and any other matters pertinent to the scope of activities to be conducted under such Collaboration Plan. |
1.23 |
“Combination Product” means a product that includes a Licensed Compound in combination with one or more pharmaceutically active ingredients that is not any |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.25 |
“Commercial Manufacturing” means Manufacture of a Licensed Product (including the cost of API) or acquisition of such Licensed Product, in each case, for Commercialization of such Licensed Product in the Profit-Sharing Territory. |
1.27 |
“Commercialization Budget” means the budget for conducting the corresponding Commercialization Plan for a given Licensed Product as presented by GSK to the applicable JCC pursuant to Section 6.2.3, and as updated on a Calendar Year basis by GSK. |
1.28 |
“Commercialization Excess Costs” has the meaning set forth in Schedule 7.4.1. |
1.29 |
“Commercialization Plan” means a plan for the Commercialization of WRN Products or MAT2A Products, as applicable, each in the Field in the Profit-Sharing Territory as presented by GSK to the applicable JCC pursuant to Section 6.2.3, and as updated annually by GSK. |
1.30 |
“Commercialization Permitted Overage” has the meaning set forth in Schedule 7.4.1. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
issues of patent coverage, safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position, the regulatory structure involved, profitability (including pricing and reimbursement status achieved or projected to be achieved), and other relevant factors, including technical, legal, scientific or medical factors. For purposes of clarity, it is anticipated that the level of effort may be different for different markets and may change over time, reflecting changes in the status of the product and the market(s) involved. |
1.32 |
“Committee” means, individually, the JSC, each JDC, each JCC and the Financial Working Group or any other Subcommittee established as set forth in Section 5.6. |
1.33 |
“Committee Deadlock” has the meaning set forth in Section 5.8.1. |
1.34 |
“Common Stock” has the meaning set forth in Section 7.1. |
1.35 |
“Companion Diagnostic” means a product designed for use in a diagnostic biomarker assay tailored or optimized for use with a Licensed Product, for predicting or monitoring the suitability of such Licensed Product for prophylactic or therapeutic use in human patients or defined subpopulations thereof. A Companion Diagnostic shall be intended for use (a) as a means to select or monitor the patient population for the conduct of clinical studies of such Licensed Product, (b) to predict predisposition to treatment in clinical use with such Licensed Product, or (c) to predict or monitor potential safety considerations in clinical use with such Licensed Product. Use of a Companion Diagnostic to guide use of the Licensed Product will be contingent on appropriate Regulatory Approvals for such uses as deemed necessary by the FDA or other similar Regulatory Authority with appropriate jurisdiction. |
1.37 |
“Confidential Information” means any technical, business, or other information provided by or on behalf of one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) in connection with this Agreement, whether prior to, on, or after the Effective Date, including under the CDA, including information relating to the GSK Technology, where GSK is the Disclosing Party, and information relating to the IDEAYA Technology, where IDEAYA is the Disclosing Party, or the scientific, regulatory or business affairs or other activities of the Disclosing Party. |
1.38 |
“Control” (including variations such as “Controlled,” “Controlling” and the like) means, with respect to any material, information, or intellectual property, the possession (whether by ownership or license, other than the licenses granted hereunder) of the ability to grant a license or sublicense or other right to exploit, without violating the terms of any agreement or other arrangement with any Third Party, or any Applicable Law. |
1.39 |
“Controlling Party” has the meaning set forth in Section 10.2.1. |
1.40 |
“Cost Share End Date” has the meaning set forth in Section 7.5.1. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.41 |
“Cost Share Opt Out Compounds and Products” means any Licensed Compounds and Licensed Products for which IDEAYA has exercised the IDEAYA Opt-Out. |
1.42 |
“Cost Share Ratio” has the meaning set forth in Section 6.2.5. |
1.44 |
“Data” means preclinical data (including computational validation, genetic data (including genotype, phenotype and genetic sequencing data), in vitro and in vivo data), clinical data (including broad data sets, study and investigator reports, both preliminary and final, statistical analyses, expert opinions and reports, safety and other electronic databases), and regulatory, Manufacturing, biological, chemical, pharmacological, toxicological, pharmaceutical, physical, analytical, safety and quality control data, information and documentation, whether in written or electronic form. |
1.45 |
“Data Security Breach” has the meaning set forth in Section 9.4. |
1.46 |
“Data Sharing Initiative” means GSK’s policy initiative (as may be amended from time to time), known at the Execution Date as the “SHARE Initiative”, to provide researchers with access to clinical trial and study information, including anonymized patient level data. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.51 |
“Development Reports” has the meaning set forth in Section 6.2.7. |
1.52 |
“Disclosing Party” has the meaning set forth in the definition of “Confidential Information.” |
1.54 |
“DOJ” has the meaning set forth in Section 2.2. |
1.55 |
“Effective Date” has the meaning set forth in Section 2.1. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.56 |
“EMA” means the European Medicines Agency, or any successor entity thereto performing similar functions for the European Union or the United Kingdom. |
1.57 |
“Entity” has the meaning set forth in Section 7.14.4. |
1.58 |
“European Union” means the economic, scientific and political organization of member states in Europe, as it may be constituted from time to time, including Switzerland and the United Kingdom. |
1.59 |
“Excess Costs” has the meaning set forth in Section 7.3.2(b). |
1.60 |
“Execution Date” has the meaning set forth in the preamble. |
1.61 |
“Exercise Period” has the meaning set forth in Section 8.1. |
1.62 |
“FDA” means the U.S. Food and Drug Administration, or any successor entity thereto performing similar functions in the United States. |
1.63 |
“Field” means any use or purpose, including the treatment, palliation, diagnosis or prevention of any human or animal disease. |
1.64 |
“Financial Report” has the meaning set forth in Schedule 7.3.1. |
1.65 |
“Financial Working Group” has the meaning set forth in Section 5.5. |
1.66 |
“First Commercial Sale” means, with respect to a given Licensed Product in a country, the first commercial sale in an arms-length transaction of such Licensed Product by or on behalf of GSK, its Affiliate or Sublicensee in such country following receipt of applicable Regulatory Approval of such Licensed Product in such country; provided, however, that First Commercial Sale shall not include any transfer of a product (a) between or among GSK and its Affiliates or its Sublicensees or (b) for purposes of patient assistance programs, treatment IND sales, named patient sales, compassionate use sales or the like, provided, in case of (b), such product is sold at a price no greater than GSK’s fully burdened cost of manufacture, distribution and selling. |
1.67 |
“Force Majeure” means any event beyond the reasonable control of the affected Party, including: embargoes; war or acts of war, including terrorism; insurrections, riots, or civil unrest; strikes, lockouts or other labor disturbances; epidemics (including pandemics), fire, floods, earthquakes or other acts of nature; or acts, omissions or delays in acting by any governmental authority (including the refusal of any Regulatory Authority to issue required Regulatory Approvals due to reasons other than the affected Party’s negligence or willful misconduct or any other cause within the reasonable control of the affected Party), and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances). |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.69 |
“FTE” means, with respect to employees of a Party or its Affiliates, the equivalent of the work of one (1) full time person for one (1) year (consisting of at least a total of [***] ([***]) hours per year, or such other number as may be agreed to by the Parties). Overtime, and work on weekends, holidays and the like shall not be counted with any multiplier (e.g., time-and-a-half or double time) toward the number of hours that are used to calculate the FTE contribution. If any person works partially on other work in a given Calendar Year, then the full-time equivalent to be attributed to such person’s work hereunder shall be equal to the percentage of such person’s total work time in such Calendar Year that such person spent working on activities contemplated under this Agreement. FTE efforts shall not include the work of general corporate personnel. Each Party shall track FTEs of its personnel using such Party's standard practices and methodologies. |
1.70 |
“FTE Rate” means, unless otherwise agreed by the unanimous decision of the Financial Working Group or mutually by the Parties in writing, commencing on the Effective Date, $[***] per FTE. The FTE Rate shall be increased or decreased on each anniversary of the Effective Date by a percentage equivalent to the change over the preceding twelve (12)-month period in the Consumer Price Index for All Urban Consumers (All Items), or any successor to such published measure, not seasonally adjusted, as published by the U.S. Department of Labor Bureau of Labor Statistics. For clarity, the FTE Rate is “fully burdened” and covers base salary, target bonus (yearly bonus based on achievement of personal/corporate targets), plus benefits including holiday allowance, pension, medical, risk, share-based payments and other remuneration-based benefits, tax and social security, facilities, travel expenses, and IT allocation. |
1.71 |
“GAAP” means generally acceptable accounting standards, principles, and procedures as issued by the Financial Accounting Standards Board (FASB). |
1.72 |
“GCP” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials, including, as applicable, (a) FDA regulations and guidelines for good clinical practice, as promulgated by the FDA under 21 CFR Parts 50, 54, 56, 312 and 812, (b) as set forth in European Commission Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, and brought into law by European Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice for investigational medicinal products, (c) the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (“ICH”) Harmonised Tripartite Guideline for Good Clinical Practice (CPMP/ICH/135/95) and any other guidelines for good clinical practice for trials on medicinal products in the EU, (d) the Declaration of Helsinki (2008), and (e) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which clinical studies of a product are conducted. |
1.73 |
“Generic Product” means, with respect to a Licensed Product, any pharmaceutical product that has the same active pharmaceutical ingredient as a Licensed Product |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
and that is distributed by a Third Party under an MAA approved by a Regulatory Authority in reliance, in whole or in part, on the prior approval (or on safety or efficacy data submitted in support of the prior approval) of such Licensed Product. |
1.74 |
“GLP” means all applicable Good Laboratory Practice standards, including, as applicable: (a) FDA regulations and guidelines for good laboratory practice, as promulgated by the FDA under 21 CFR Part 58; (b) European Commission Directive 2004/10/EC relating to the application of the principles of good laboratory practices, as may be amended from time to time as well as any Rules Governing Medicinal Products in the European Community Vol. III, ISBN 92.825 9619-2 (ex - OECD principles of GLP); and (c) any further amendments or clarifications with respect to any of the foregoing and any equivalents thereto in the country in which pre-clinical or clinical studies of a product are conducted. |
1.75 |
“GLP Toxicology Study” means a pre-clinical toxicity safety study conducted under GLP with respect to the applicable Licensed Compound to generate data to support filing of an IND. |
1.76 |
“GMP” means all applicable Good Manufacturing Practices, including: (a) the applicable part of quality assurance to ensure that products are consistently produced and controlled in accordance with the quality standards appropriate for their intended use, as defined in European Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice; (b) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Sections 210, 211, 601, 610 and 820; (c) the Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products; (d) the principles detailed in the ICH Q7A guidelines; and (e) the equivalent Laws in any relevant country, each as may be amended and Applicable from time to time. |
1.77 |
“Government Official” (where “government” means all levels and subdivisions of governments, i.e. local, regional, national, administrative, legislative, executive, or judicial, and royal or ruling families) means (a) any officer or employee of a government or any department, agency or instrumentality of a government (which includes public enterprises, and entities owned or controlled by the state); (b) any officer or employee of a public international organization such as the World Bank or United Nations; (c) any officer or employee of a political party, or any candidate for public office; (d) any individual defined as a government or public official under Applicable Laws (including anti-bribery and corruption laws) and not already covered by any of the above; or (e) any individual acting in an official capacity for or on behalf of any of the above. “Government Official” includes any individual with close family members who are Government Officials (as defined above) with the capacity, actual or perceived, to influence or take official decisions affecting the business of a Party. |
1.78 |
“GSK” has the meaning set forth in the preamble. |
1.79 |
“GSK Arising Know-How” has the meaning set forth in Section 10.1.3. |
1.80 |
“GSK Arising Patents” has the meaning set forth in Section 10.1.3. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.82 |
“GSK Existing Patents” has the meaning set forth in Section 10.1.1. |
1.83 |
“GSK Existing Know-How” has the meaning set forth in Section 10.1.1. |
1.84 |
“GSK Existing Technology” has the meaning set forth in Section 10.1.1. |
1.85 |
“GSK Indemnitees” has the meaning set forth in Section 14.1.1. |
1.86 |
“GSK MAT2A Preclinical Activities” has the meaning set forth in Section 3.2.1(b). |
1.87 |
“GSK Patents” has the meaning set forth in Section 10.2.3. |
1.88 |
“GSK PRMT Product” means a compound that is a Type 1 protein arginine methyl transferase inhibitor that is Controlled by GSK. |
1.90 |
“GSK Termination Technology” means (a) all GSK Existing Technology, (b) all GSK Arising Technology Controlled by GSK, (c) GSK’s joint ownership interest in Joint Arising Technology Controlled by GSK and (d) subject to [***], in each case that are (i) [***] or (ii) otherwise [***]. |
1.91 |
“Xxxxx-Xxxxxx Act” has the meaning set forth in Section 10.3.1. |
1.92 |
“HSR Act” has the meaning set forth in Section 2.2. |
1.93 |
“HSR Clearance Date” has the meaning set forth in Section 2.2. |
1.94 |
“HSR Filing” has the meaning set forth in Section 2.2. |
1.95 |
“ICC Rules” has the meaning set forth in Section 15.2. |
1.96 |
“IDEAYA” has the meaning set forth in the preamble. |
1.97 |
“IDEAYA Arising Know-How” has the meaning set forth in Section 10.1.4. |
1.98 |
“IDEAYA Arising Patents” has the meaning set forth in Section 10.1.4. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.100 |
“IDEAYA Existing Patents” has the meaning set forth in Section 10.1.1. |
1.101 |
“IDEAYA Existing Know-How” has the meaning set forth in Section 10.1.1. |
1.102 |
“IDEAYA Existing Technology” has the meaning set forth in Section 10.1.1. |
1.103 |
“IDEAYA Indemnitees” has the meaning set forth in Section 14.1.2. |
1.104 |
“IDEAYA Opt-Out” has the meaning set forth in Section 7.5.1. |
1.105 |
“IDEAYA Technology” means (a) all IDEAYA Existing Technology, (b) all IDEAYA Arising Technology Controlled by IDEAYA during the Term, and (c) IDEAYA’s joint ownership interest in Joint Arising Technology Controlled by IDEAYA during the Term, in each case, that are necessary or reasonably useful for the making, having made, using, selling, offering for sale and importing Licensed Compounds and Licensed Products in the Field in the Territory. |
1.106 |
“IFRS” means the International Financial Reporting Standards as adopted by the European Union, applied on a consistent basis. |
1.107 |
“Increased Withholding Taxes” has the meaning set forth in Section 7.14.2. |
1.108 |
“IND” means an Investigational New Drug Application (including any amendments thereto) filed with the FDA pursuant to 21 CFR Part 312, or any equivalent filing with any relevant Regulatory Authority in any jurisdiction. |
1.109 |
“Indemnifying Party” has the meaning set forth in Section 14.1.3. |
1.110 |
“Indemnitee” has the meaning set forth in Section 14.1.3. |
1.111 |
“Infringement” has the meaning set forth in Section 10.3.1. |
1.112 |
“Infringement Notice” has the meaning set forth in Section 10.3.1. |
1.113 |
“Initiation” means, with respect to any (a) clinical study, including a [***], the first patient dosed in such clinical trial, and (b) GLP Toxicology Study, first dosing in an animal species in such GLP Toxicology Study. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.115 |
“Interim MAT2A Activities” has the meaning set forth in Section 3.2.1(c). |
1.116 |
“Interim MAT2A Operating Period” has the meaning set forth in Section 3.2.1(c). |
1.117 |
“Internal Policies” means, with respect to a Party, such Party’s health care compliance, ethical, reputational, anti-bribery and corruption and other policies applicable to such Party’s activities under this Agreement, and any standard operating procedures implementing such policies, including the codes of conduct of any self-regulatory body of which that Party is a member. |
1.118 |
“Joint Arising Technology” has the meaning set forth in Section 10.1.5. |
1.119 |
“Joint Commercialization Committee” or “JCC” has the meaning set forth in Section 5.4.1. |
1.120 |
“Joint Development Committee” or “JDC” has the meaning set forth in Section 5.2.1. |
1.121 |
“Joint Steering Committee” or “JSC” has the meaning set forth in Section 5.1.1. |
1.122 |
“Know-How” means proprietary and confidential trade secrets, models, discoveries, ideas, Data and other types of data, databases, results, assays, instructions, processes, techniques, formulas, algorithms, Materials, inventions, computational models, human-relevant disease models, computer software (including source code), predictive model implementations, data analytic tools, biotechnology hardware and associated algorithms and methodologies, methods of use, expert knowledge and information. |
1.123“Launch Preparation Activities” means all Commercialization activities undertaken with respect to a relevant Licensed Product in the Territory prior to First Commercial Sale and in preparation for First Commercial Sale of such Licensed Product in the Territory. Launch Preparation Activities shall exclude all Development activities.
1.124 |
“Licensed Compound” means (a) solely if the Option Closing Date occurs, a MAT2A Compound, (b) a WRN Compound, or (c) a POLQ Compound. |
1.125 |
“Licensed Product” means (a) solely if the Option Closing Date occurs, a MAT2A Product, (b) a WRN Product, or (c) a POLQ Product. For clarity, if a given Licensed Product contains (i) [***] or (ii) [***], such Licensed Product shall be considered to be multiple Licensed Products for the purposes of this Agreement, [***]. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(i)the [***], or the [***], shall [***]; and
(ii)the determination whether a [***] is a separate Major Indication shall be guided by generally accepted medical treatment and standards in the field of oncology, as such may develop during the Term.
1.128 |
“Manufacture” means all activities related to the synthesis, making, production, processing, purifying, formulating, filling, finishing, packaging, serialization, labeling, shipping, and holding of any product, or any component or intermediate thereof, including process development, process qualification and validation, scale-up, qualification, validation, pre-clinical, clinical and commercial production and analytic development, product characterization, stability testing, quality assurance, and quality control. “Manufacturing” shall have a correlative meaning. |
1.129“Manufacturing Cost” means, with respect to a Licensed Product, GSK’s reasonable and necessary FTE Costs and Third Party invoiced cost, determined in accordance with IFRS, and the terms and conditions of this Agreement, incurred in Manufacturing or acquisition of such Licensed Product, in each case to the extent [***], which shall be:
1.129.1for such Licensed Product (or components thereof) Manufactured [***]; and
1.129.2for such Licensed Product (or components thereof) Manufactured [***]. Such costs include the following costs incurred by GSK or its Affiliates:
(a)“[***]” are, for purposes of ongoing cost accounting purposes, budgeted unit costs of [***], and consistent with customary practice; and
(b)“Cost Variances” are actual costs of Manufacturing [***], and consistent with customary practice (including volume variances, variable overhead spending variances and fixed overhead spending variances).
“Manufacturing FTE Costs” means, as applicable with respect to any period, the FTE Rate(s) for Manufacturing activities, multiplied by the number of FTEs performing such Manufacturing activities under this Agreement, respectively, during such period.
Manufacturing Cost shall not include [***]. Subject to the foregoing, all Manufacturing Costs shall be calculated [***]. In addition, Manufacturing Costs shall exclude costs that result from the [***]. Only the portion of Manufacturing Cost of each Licensed Product that is associated with
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
such Licensed Product for use in Commercialization in the Profit-Sharing Territory shall be included in the definition of Pre-Tax Profit or Loss.
1.130 |
“Marketing Approval Application” or “MAA” means an NDA or any corresponding application in the applicable country or jurisdiction outside of the United States, including, with respect to the European Union, an application for Regulatory Approval filed with the EMA pursuant to the centralized approval procedure, or with the applicable national Regulatory Authority of a country in the European Union with respect to the mutual recognition procedure, decentralized procedure or any other national approval and with respect to Japan, an application for Regulatory Approval filed with the MHLW. |
1.131 |
“MAT2A Combination Study” means a Phase 1 Clinical Study combining a MAT2A Product with any pharmaceutical preparation, substance, formulation or dosage which is comprised of or contains a GSK PRMT Product. |
1.133 |
“MAT2A CTCSA” has the meaning set forth in Section 3.2.1(b). |
1.134 |
“MAT2A Development Costs” has the meaning set forth in Section 6.2.4. |
1.135 |
“MAT2A Development Program” has the meaning set forth in Section 5.2.1. |
1.136 |
“MAT2A Patents” has the meaning set forth in Section 10.2.1. |
1.137 |
“MAT2A Product” means any pharmaceutical preparation, substance, formulation or dosage which is comprised of or contains a MAT2A Compound (whether or not such MAT2A Compound is the sole active ingredient). |
1.138 |
“MAT2A Program” has the meaning set forth in Section 3.1. |
1.139 |
“MAT2A Program Costs” means all Development Costs incurred by IDEAYA or its Affiliates in the performance of the MAT2A Program in accordance with the applicable Collaboration Plan up to and until the Option Package Delivery Date. For the avoidance of doubt, the costs of conducting the MAT2A Combination Study shall be borne by GSK as set out in this Agreement and the MAT2A CTCSA and are not included in the MAT2A Program Costs; provided that, if the MAT2A Combination Study is conducted by IDEAYA as a combination arm of its Phase 1 Clinical Study of the MAT2A Product that also includes a Phase 1 MAT2A Monotherapy Study arm, then GSK will only pay for such combination arm and control arm, and not the Phase 1 MAT2A Monotherapy Study arm of such Phase 1 Clinical Study. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.141 |
“MAT2A Target” means methionine adenosyltransferase II alpha. |
1.142 |
“Material Receiving Party” means the Party receiving Materials from the other Party as contemplated in Section 3.2.5(a). |
1.143 |
“Materials” means any chemical or biological substances, including any biological or chemical compounds, drug products, human samples, or other materials, regardless of the route of transfer, which are supplied by a Party or its nominee to the other Party or its nominee for use in the conduct of activities under this Agreement, including any applicable Collaboration Plan or Development Plan. |
1.144 |
“Materials Transferring Party” means the Party providing Materials to the other Party as contemplated in Section 3.2.5(a). |
1.145 |
“MTR” has the meaning set forth in Section 3.2.5(a). |
1.146 |
“MHLW” means the Ministry for Health, Labor and Welfare of Japan, or the Pharmaceutical and Medical Devices Agency (the “PMDA”), or any successor to either of them, as the case may be. |
1.147 |
“NDA” means a New Drug Application (as more fully defined in 21 C.F.R. 314.5 et seq. or its successor regulation) and all amendments and supplements thereto filed with the FDA. |
1.148 |
“Net Sales” means, with respect to a Licensed Product during a stated time period, the gross invoiced sales amounts for such Licensed Product sold by or on behalf of GSK, its Affiliates or Sublicensees in arm’s length transactions to Third Parties (but not including sales relating to transactions by and between GSK, its Affiliates or Sublicensees) less the following deductions from such gross amounts which are actually incurred, allowed, paid, accrued or specifically allocated to the extent that such amounts are deducted from gross invoiced sales amounts as reported by GSK in its financial statements in accordance with IFRS, applied on a consistent basis: |
(a)credits or allowances actually granted for a damaged Licensed Product, returns or rejections of the Licensed Product, price adjustments, and billing errors;
(b)governmental and other rebates (or equivalents thereof) to national, state/provincial, local and other governments, their agencies and purchasers, and reimbursers, or to trade customers;
(c)normal and customary trade, cash and quantity discounts, allowances, and credits actually allowed or paid;
17
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(d)commissions allowed or paid to Third Party distributors, brokers or agents other than sales personnel, sales representatives and sales agents employed or engaged by GSK;
(e)transportation costs, including insurance, for outbound freight related to delivery of the Licensed Product to the extent included in the gross amount invoiced; and
(f)non-recoverable sales taxes, value added taxes, and other taxes directly linked to the sales of the Product to the extent included in the gross amount invoiced; and
(g)any other items actually deducted from gross invoiced sales amounts as reported by GSK in its financial statements in accordance with IFRS, applied on a consistent basis.
Upon any sale or other disposal of the Licensed Product that should be included within Net Sales for any consideration other than an exclusively monetary consideration on bona fide arm’s length terms, then for purposes of calculating the Net Sales under this Agreement, the Licensed Product shall be deemed to be sold exclusively for money at the average sales price during the applicable reporting period generally achieved for the Licensed Product in the country in which such sale or other disposal occurred.
Notwithstanding the foregoing, (i) Net Sales shall not include disposals of the Licensed Product for, or use of the Licensed Product in, clinical or pre-clinical trials, given as free samples, or distributed at no charge to patients unable to purchase the Licensed Product and (ii) Net Sales shall not include amounts for any Licensed Product distributed for compassionate, named patient or similar use provided at no charge.
In the event a Licensed Product containing specific Licensed Compound(s) is sold as a Combination Product in a given country, the Net Sales of such Licensed Product, solely for the purposes of determining royalty payments (and for clarity not with respect to the calculation of Net Sales of Combination Products for the purpose of determining Pre-Tax Profit or Loss for the Profit-Sharing Territory), shall be determined by multiplying the Net Sales of such Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average sale price in a particular country of the Licensed Product containing the relevant Licensed Compound(s) as the sole active ingredient(s) when sold separately in finished form in such country and B is the weighted average sale price in that country of the product containing Other Components as the sole active ingredient when sold separately in finished form. In the event that such weighted average sale price cannot be determined for either the Licensed Product containing the relevant Licensed Compound(s) as sole active ingredients or product containing the Other Components, each as sold separately in such country, comprising such Combination Product, the Parties shall negotiate in good faith a reasonable adjustment to Net Sales of such Combination Product solely for purposes of determining royalty payments (and for clarity not with respect to the calculation of Net Sales of Combination Products for the purpose of determining Pre-Tax Profit or Loss for the Profit-Sharing Territory), based on the following methodology: the Net Sales of the
18
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Combination Product will be multiplied by the fraction C/D where C equals [***] and D equals [***].
1.149 |
“Net Sales Territory” means (a) for POLQ Products, the Territory, and (b) for MAT2A Products and WRN Products, the Territory excluding the Profit-Sharing Territory. For clarity, effective as of the effective date of an IDEAYA Opt-Out, “Net Sales Territory” means the Territory with respect to Cost Share Opt Out Compounds and Products. |
1.150 |
“Option” has the meaning set forth in Section 8.1. |
1.151 |
“Option Closing Date” has the meaning set forth in Section 8.1. |
1.153 |
“Option Exercise” has the meaning set forth in Section 8.1. |
1.154 |
“Option Fee” has the meaning set forth in Section 7.6. |
1.155 |
“Option Package Delivery Date” means the date on which the Option Data Package is provided by IDEAYA to GSK in accordance with this Agreement. |
1.156 |
“Orange Book” means the FDA publication titled “Approved Drug Products with Therapeutic Equivalence Evaluations.” |
1.157 |
“Other Component(s)” has the meaning set forth in Section 1.23. |
1.158 |
“Other Product” has the meaning set forth in Section 2.3.2. |
1.159 |
“Party” or “Parties” has the meaning set forth in the preamble. |
1.160 |
“Patent Costs” means all out-of-pocket expenses (including reasonable attorneys’ fees) incurred in the preparation, prosecution, filing and maintenance of the Subject Patents. |
1.161 |
“Patent Liaisons” has the meaning set forth in Section 5.10. |
1.162 |
“Patents” means all patents and pending patent applications (including inventor’s certificates and utility models) and any patents issuing therefrom, in any country in the Territory, including any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisional and other continuing applications, supplementary protection certificates, renewals, and any and all reissues, extensions, registrations, reexaminations, extensions, confirmations, registrations and patents of addition on any of the foregoing. |
1.163 |
“Payee” has the meaning set forth in Section 7.14.2. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.165 |
“Permitted Overage” has the meaning set forth in Section 7.3.2(a). |
1.166 |
“Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof. |
1.167 |
“Personally Identifiable Information (PII)” means information that can be used to distinguish or trace an individual’s identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual, including: (a) a first and last name; (b) a home or other physical address, including street name and name of city or town; (c) an email address or other online contact information, such as an instant messaging user identifier or a screen name that reveals an individual’s email address; (d) a telephone number; (e) a social security number; (f) a bank, loan, or credit card account number; (g) a persistent identifier, such as a customer number held in a “cookie” or processor serial number, that is combined with other available data that identifies an individual consumer; or (h) any information that is combined with any of (a) through (g) above. |
1.168 |
“Phase 1 Clinical Study” means a human clinical trial of a product in any country, the principal purpose of which is a preliminary determination of safety in patients, that would satisfy the requirements of 21 C.F.R. 312.21(a), or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States. |
1.169 |
“Phase 1 MAT2A Monotherapy Study” has the meaning set forth in Section 3.2.1(b). |
1.171 |
“POLQ Product” means any pharmaceutical preparation, substance, formulation or dosage which is comprised of or contains a POLQ Compound (whether or not such POLQ Compound is the sole active ingredient). For clarity and without limitation, [***]. |
1.172 |
“POLQ Program” has the meaning set forth in Section 3.1. |
1.173 |
“POLQ Program Costs” has the meaning set forth in Section 7.2. |
1.174 |
“POLQ Report” has the meaning set forth in Section 6.1.3. |
1.175 |
“POLQ Target” means DNA polymerase theta. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.177 |
“Pre-Tax Profit or Loss Schedule” means the schedule set forth in Schedule 7.4.1 attached hereto. |
1.178 |
“Private Placement” has the meaning set forth in Section 7.1.2. |
1.179 |
“Product Claims” has the meaning set forth in Schedule 7.4.1. |
1.180 |
“Profit-Sharing Term” has the meaning set forth in Section 7.4.1. |
1.181 |
“Profit-Sharing Territory” means the United States only with respect to any WRN Product or MAT2A Product for which the Parties are then sharing Pre-Tax Profit or Loss. |
1.182 |
“Public Offering” has the meaning set forth in the Purchase Agreement. |
1.183 |
“Purchase Agreement” has the meaning set forth in Section 7.1.2. |
1.184 |
“Purchase Price” has the meaning set forth in the Purchase Agreement. |
1.185 |
“Receiving Party” has the meaning set forth in the definition of “Confidential Information.” |
1.186 |
“Reconciliation Procedures” has the meaning set forth in the Pre-Tax Profit and Loss Schedule. |
1.187 |
“Registration Study” means, with respect to a given Licensed Product, any pivotal clinical study of such Licensed Product for the purpose of establishing safety and efficacy of such Licensed Product in patients with the disease or condition being studied for purposes of filing an NDA with the FDA, as described under 21 C.F.R. §312.21(c) with respect to the United States, or, with respect to a jurisdiction other than the United States, a similar clinical study for the purpose of enabling the filing of a Marketing Approval Application equivalent to an NDA with the applicable Regulatory Authority(ies) in such jurisdiction. For the avoidance of doubt, Registration Study includes an adaptive study only at such time and to the extent such adaptive study meets the criteria of a pivotal study sufficient for registration. |
1.188 |
“Regulatory Approval” means all approvals, licenses, registrations or authorizations of any Regulatory Authority, necessary for the Manufacturing, use, storage, import, export, transport, or Commercialization of a Licensed Product, as applicable, in a regulatory jurisdiction in the Territory, including approval of any Marketing Approval Application. |
1.189 |
“Regulatory Authority” means the FDA, the EMA, the MHLW or any regulatory body with similar regulatory authority in any other jurisdiction anywhere in the world. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.191 |
“Relative U.S. Market Share” has the meaning set forth in Section 6.2.5. |
1.192 |
“Royalty Term” has the meaning set forth in Section 7.12.1. |
1.193 |
“Senior Manager” has the meaning set forth on Section 15.1.1. |
1.194 |
“Shared Development Costs” has the meaning set forth in Section 7.3.1. |
1.195 |
“Subcommittee” has the meaning set forth in Section 5.6. |
1.196 |
“Subcommittee Deadlock” has the meaning set forth in Section 5.8.1. |
1.197 |
“Subject Patents” has the meaning set forth in Section 10.2.1. |
1.198 |
“Sublicensee” has the meaning set forth in Section 8.4. |
1.199 |
“Target” means each of the MAT2A Target, POLQ Target and WRN Target; provided that, if applicable, as of the expiration of the Exercise Period without GSK’s exercise of the Option hereunder, the MAT2A Target shall immediately cease to be considered a “Target”. |
1.200 |
“Tax” or “Taxes” means any present or future taxes, levies, imposts, duties, charges, assessments or fees of any nature (including interest, penalties and additions thereto). |
1.201 |
“Term” has the meaning set forth in Section 11.1. |
1.202 |
“Terminated Compounds” and “Terminated Products” has the meaning set forth in Section 12.2. |
1.203 |
“Termination Date” means the earliest to occur of (a) [***], (b) the Closing Date, (c) the valid termination of the Purchase Agreement pursuant to the termination provisions contained therein, (d) the valid termination, prior to the Closing Date, of the obligations set forth in Section 7.1.2 of this Agreement pursuant to a written instrument signed by IDEAYA and GSK, (e) the valid termination, prior to the Closing Date, of this Agreement, pursuant to Section 2.2 hereof, or (f) a Change of Control of IDEAYA prior to the Closing Date. |
1.204 |
“Territory” means all countries and territories in the world. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.205 |
“Third Party” means a person or entity other than (a) IDEAYA and its Affiliates, and (b) GSK and its Affiliates. |
1.206 |
“Third Party Infringement Claim” has the meaning set forth in Section 10.4.1. |
1.207 |
“[***]” means [***]. |
1.208 |
“Total Equity Commitment” has the meaning set forth in Section 7.1.2. |
1.209 |
“True Up Costs” has the meaning set forth in Section 6.2.5. |
1.210 |
“[***]” means a [***]. |
1.211 |
“United States” or “U.S.” means the United States and its territories and possessions. |
1.212 |
“Valid Patent Claim” means a claim of any issued, unexpired Patent within the Joint Arising Technology, IDEAYA Existing Patents, IDEAYA Arising Patents or GSK Arising Patents that shall not have lapsed, been revoked, cancelled or abandoned, been donated to the public, finally disclaimed, nor held finally invalid or unenforceable by a court of competent jurisdiction in an unappealed or unappealable decision and which has not been held unenforceable through disclaimer or otherwise. |
1.213 |
“VAT” means any value added, sales, use, purchase, turnover or consumption tax as may be applicable in any relevant jurisdiction, including but not limited to value added tax chargeable under legislation implementing EU Council Directive 2006/112/EC. |
1.214 |
“WRN Development Costs” has the meaning set forth in Section 6.2.4. |
1.215 |
“WRN Development Program” has the meaning set forth in Section 5.2.1. |
1.217 |
“WRN Product” means any pharmaceutical preparation, substance, formulation or dosage which is comprised of or contains a WRN Compound (whether or not such WRN Compound is the sole active ingredient). For clarity and without limitation, [***]. |
1.218 |
“WRN Program” has the meaning set forth in Section 3.1. |
23
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
1.219 |
“WRN Program Costs” means all Development Costs incurred for activities conducted in accordance with the applicable Collaboration Plan and Collaboration Budget for the WRN Program. |
1.220 |
“WRN Target” means Xxxxxx Syndrome Helicase-Nuclease protein. |
ARTICLE 2
EffectiveNess; Exclusivity
24
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
ARTICLE 3
Collaboration Programs
25
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
respect to the POLQ Program and WRN Program) may be amended from time to time as set forth in this Agreement. |
(a) |
it is anticipated that the Parties will generally share equal responsibility for activities to be conducted under the POLQ Program and WRN Program though such sharing may not be equal where a Party’s unique capabilities are leveraged for the benefit of the applicable Collaboration Program; and |
(1)Notwithstanding the foregoing, GSK shall have the right to conduct, or may request IDEAYA to conduct, the MAT2A Combination Study pursuant to a separate clinical trial collaboration and supply agreement to be entered into by the Parties within [***] days after GSK provides written notification to IDEAYA of its decision to proceed with the MAT2A Combination Study regardless of which Party will conduct it (the “MAT2A CTCSA”); provided that the MAT2A CTCSA shall contain at least the terms set forth on Schedule 3.2.1(b). Except as specifically set forth in this Agreement, the MAT2A CTCSA shall contain the terms and conditions governing the conduct of the MAT2A Combination Study.
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
parameters outlined by the JDC, continue the Development of the MAT2A Compounds and MAT2A Products (the “Interim MAT2A Activities”). |
3.2.2 |
Data Integrity Practices. All activities conducted under the Collaboration Plans, including the conduct of any clinical studies, will be conducted in accordance with the following practices: |
(a) |
Data will be generated using sound scientific techniques and processes; |
(b) |
Data will be accurately recorded by the persons performing the applicable development activities in accordance with data integrity practices; |
(c) |
Data will be analyzed appropriately without bias in accordance with data integrity practices; |
(d) |
Data and results from experiments and clinical studies will be stored securely such that it can be retrieved without undue burden; and |
(e) |
Data trails will exist to demonstrate or reconstruct without undue burden key decisions made during the performance of, presentations made about, and conclusions reached with respect to the activities undertaken in the performance of the Collaboration Plans. |
(f) |
At any time after the Effective Date and for so long as IDEAYA is conducting activities under any Collaboration Plan, GSK may request changes to the requirements set forth above in this Section 3.2.2 where GSK reasonably believes such changes are required to ensure that such activities are undertaken in compliance with data integrity practices, and IDEAYA shall use reasonable efforts to accommodate such changes. GSK shall be permitted, in its sole discretion and sole cost and expense, no more than once per Calendar Year, to undertake on-site compliance audits of IDEAYA’s data integrity practices in respect of the activities performed by IDEAYA under each Collaboration Plan by providing IDEAYA with [***] days’ written notice of GSK’s intent to do so, such audits to be conducted at a time mutually convenient to both Parties. All information revealed to GSK in such audit shall be considered Confidential Information of IDEAYA. |
27
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
practices or Applicable Laws may be additive to the core principles, but the Parties agree to comply and shall procure and ensure that those acting for or on behalf of each Party (including each Party’s subcontractors or collaborators) comply, at a minimum, with these core principles: [***]. |
(b) |
If a Party is currently accredited by AAALACi, then such Party agrees to use Commercially Reasonable Efforts to maintain its AAALACi accreditation during the Term. |
(d) |
Upon reasonable advanced written notice of at least [***] days to IDEAYA, GSK (or its delegate) shall have the right to inspect, at its sole cost and expense, IDEAYA’s records solely as they relate to the conduct of animal work under a Collaboration Plan for a maximum of once per Calendar Year unless otherwise agreed by IDEAYA in writing. The scope of the inspection may include the opportunity to view relevant SOPs, training records, building management records, animal health records, ethical review documents, and any other documents reasonably necessary to assess compliance by IDEAYA with any of the terms and conditions of this Section 3.2.3; provided that such inspection shall not extend to those parts of the records and facilities which IDEAYA can demonstrate to be subject to confidentiality arrangements with Third Parties. To the extent that any significant deficiencies are identified as the result of such inspection, IDEAYA shall endeavor in good faith to take reasonable and practical corrective measures to remedy any such material deficiencies. All information revealed to GSK in such audits shall be considered Confidential Information of IDEAYA. |
(e) |
IDEAYA shall promptly provide to GSK information regarding any significant deficiencies impacting the applicable activities under a Collaboration Plan regarding its animal care and welfare program and any corrective actions taken. IDEAYA shall use reasonable efforts to cause those acting for or on its behalf (including subcontractors or collaborators) to comply with the obligations identified in this Section 3.2.3. |
28
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
29
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
AGREEMENT IS UNDERSTOOD TO BE EXPERIMENTAL IN NATURE AND MAY HAVE HAZARDOUS PROPERTIES. THE MATERIALS RECEIVING PARTY WILL HANDLE THE MATERIAL ACCORDINGLY AND WILL INFORM THE MATERIALS TRANSFERRING PARTY IN WRITING OF ANY ADVERSE EFFECTS EXPERIENCED BY PERSONS HANDLING THE MATERIAL. |
(c) |
The Materials Receiving Party acknowledges that, except for the licenses and other express rights granted herein, it does not have any claim to the Materials supplied by the Materials Transferring Party, or any license or rights to any proprietary information or intellectual property rights in or to the Materials. For clarity, the Materials shall remain the sole and exclusive property of the Materials Transferring Party and shall be returned or destroyed at the request of the Materials Transferring Party. |
(d) |
The Materials Receiving Party agrees that the Material(s): |
(1) |
will be used solely for, and in compliance with, the activities described in the applicable Collaboration Plan, the MTR, or this Agreement; |
(2) |
will be used in compliance with all Applicable Laws; |
(3) |
will not be used in human subjects, in clinical studies, or for diagnostic purposes involving human subjects (except as otherwise described in this Agreement); |
(4) |
will be used only by the Materials Receiving Party and only in the Materials Receiving Party’s laboratory, except with the prior written consent of the Materials Transferring Party; |
(5) |
will not be transferred to a Third Party without the prior written consent of the Materials Transferring Party; and |
(6) |
the Materials Receiving Party shall not reverse engineer or attempt to determine the chemical structure, make-up or sequence of, or determine the chemical or biological properties of, or make or attempt to make any analogues, progeny or derivatives of, or modifications to, such Materials except as expressly required to carry-out such Party’s obligations hereunder, including its activities pursuant to the applicable Collaboration Plan. |
30
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
and shall, upon direction of the Materials Transferring Party, return or destroy (and certify destruction of) any remaining Material in compliance with all Applicable Laws. |
ARTICLE 4
FUNDING of THE COLLABORATION PROGRAMS
ARTICLE 5
Management of the Collaboration
5.1 |
Joint Steering Committee. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(a) |
oversee and guide the overall strategic direction of the Collaboration Programs (but without modifying or limiting the rights or obligations of either Party as otherwise set forth herein); |
(b) |
facilitate communications between the Parties regarding the activities undertaken under each Collaboration Program; |
(c) |
establish, as appropriate, additional sub-committees or working groups responsible for managing specific aspects of the Collaboration Programs or Development Programs as contemplated herein; |
(d) |
oversee and supervise the subcommittees and resolve issues or Disputes elevated to it by the JDC, JCC, Financial Working Group, or any subcommittee the JSC may establish; |
(e) |
for each Collaboration Program, review and approve Collaboration Plans and Collaboration Budgets and all amendments to any of the foregoing, as submitted by the JDC; |
(f) |
review and approve draft Development Plans and Development Budgets, annual updates thereto, and any material amendments to the foregoing; |
(g) |
coordinate with the Financial Working Group, JDC or JCC, as appropriate, with respect to the reconciliation or approval, as applicable, of Shared Development Costs, Excess Costs, and the Pre-Tax Profit or Loss; and |
(h) |
perform such other functions as are assigned to the JSC in this Agreement, or otherwise agreed by the Parties in writing. |
5.1.3 |
Term of JSC. The JSC shall meet in accordance with Section 5.7.2 for so long as either (a) the Parties are conducting activities under any Collaboration Program or (b) GSK or its Affiliates or Sublicensees are Commercializing the MAT2A Product or WRN Product in the Profit-Sharing Territory. |
32
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
applicable), to establish Development Plans and Development Budgets for MAT2A Compounds and MAT2A Products (the “MAT2A Development Program”), and coordinate on the execution of the Development Plans in accordance with such Development Budgets. |
5.2.2 |
Responsibilities of the JDCs. Each JDC shall perform the following functions for its Collaboration Program, WRN Development Program or MAT2A Development Program, as applicable, to the extent such activities are applicable to such Collaboration Program, WRN Development Program or MAT2A Development Program, as applicable: |
(a) |
oversee, review and coordinate the conduct and progress of the Development of the applicable Licensed Compound or Licensed Product, as described in the applicable Collaboration Plan and in accordance with the applicable Collaboration Budget; |
(b) |
periodically review and update the applicable Collaboration Plan, including the Collaboration Budget and the allocation of responsibilities between the Parties, from time to time, and present such Collaboration Plan and updates, as well as other amendments thereto as agreed in accordance with this Agreement, to the JSC for review and approval in accordance with Section 5.1.2; |
(d) |
review and discuss Data arising from Development activities undertaken under this Agreement; |
(e) |
coordinate with the Financial Working Group with respect to the reconciliation of Shared Development Costs, and review and approve Excess Costs and other budget overruns in consultation with the Financial Working Group; |
(f) |
review Development Reports; |
(g) |
manage the transfer of Know-How upon completion of Collaboration Programs and Option Exercise, including choosing the format and media for such transfer; |
(h) |
review draft Development Plans and Development Budgets provided by GSK, and any material amendments to the foregoing to allow IDEAYA’s representatives on the applicable JDC to comment on such Development Plans and Development Budgets for GSK’s good-faith consideration; |
(i) |
submit each JDC-reviewed Development Plan and Development Budget to the JSC for further review and approval; |
33
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(j) |
liaise with the Financial Working Group with respect to the calculation of Development Costs and sharing thereof; and |
(k) |
perform such other functions as are specifically designated to the JDC in this Agreement, or as the Parties otherwise agree in writing are appropriate to further the purposes of this Agreement. |
5.4.2 |
Responsibility of the JCCs. Each JCC shall be the forum through which GSK keeps IDEAYA informed about its Commercialization activities related to the WRN Product and MAT2A Product to facilitate transparency for planning purposes with respect to the anticipated Pre-Tax Profit and Loss. GSK shall provide the JCC with draft Commercialization Plans and Commercialization Budgets, and any material amendments to the foregoing, for review and comment. Each JCC shall submit each JCC-reviewed Commercialization Plan and Commercialization Budget to the JSC for further review and comment. Each JCC shall liaise with the Financial Working Group with respect to the calculation of the Pre-Tax Profit or Loss and shall perform such other functions as the Parties may agree in writing are appropriate to further the purposes of this Agreement. |
5.4.3 |
Term of the JCCs. Each of the JCC for the WRN Product and the JCC for the MAT2A Product shall meet in accordance with Section 5.7.2 until the expiration or termination of the Profit-Sharing Term with respect to the applicable JCC’s Licensed Product. |
34
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
35
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
and provide an agenda, along with appropriate information for such agenda, reasonably in advance of any meeting. Such agenda shall include all items requested by either Co-Chair for inclusion therein. If the Co-Chairs or another Committee member from either Party is unable to attend or participate in a meeting of such Committee, the Party whose Co-Chair or member is unable to attend may designate a substitute co-chair or other representative for the meeting. For clarity, the Alliance Manager shall assist the Co-Chairs of the JSC with respect to the foregoing activities, and attend all meetings of the JSC as a non-voting member; provided that attendance by the Alliance Manager does not count towards either Party’s representation on the JSC. |
36
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
5.8.3 |
Day-to-Day Decision-Making Authority. Each Party shall have decision making authority with respect to the day-to-day operational and tactical activities of such Party (and such Party’s employees, agents and subcontractors) under this Agreement, provided that such decisions are not inconsistent with the terms and conditions of this Agreement (including any applicable Collaboration Plan, Development Plan or Commercialization Plan) or the decisions and actions of the JSC, the JDCs, the JCCs, Financial Working Group or any other Subcommittee, as applicable. |
37
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
performed by a Party under this Agreement. Matters explicitly reserved to the consent, approval or other decision-making authority of one or both Parties, as expressly provided in this Agreement, are outside the jurisdiction and authority of the JSC, including amendment, modification or waiver of compliance with the Agreement, which shall be made by the Parties in accordance with Section 16.9. |
ARTICLE 6
POST-Collaboration Program and POST-option exercise responsibilities
6.1 |
POLQ Activities. This Section 6.1 sets forth the Parties’ responsibilities with respect to POLQ Compounds and POLQ Products after completion of the POLQ Program. |
38
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
with Regulatory Authorities regarding POLQ Compounds and POLQ Products; provided that GSK shall reimburse IDEAYA for any out-of-pocket expenses and FTE costs at the FTE Rate reasonably incurred in connection with such assistance. |
39
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
and the JSC as described in Section 6.2.2. Commercialization of the applicable Licensed Products in the Profit-Sharing Territory will be conducted solely by or on behalf of GSK in accordance with a Commercialization Plan and associated Commercialization Budget as described in Section 6.2.3. As reasonably requested by GSK from time to time during the Term, IDEAYA shall promptly provide reasonable assistance to GSK with respect to filings and other interactions with Regulatory Authorities regarding Licensed Compounds and Licensed Products; provided that costs of such assistance will be shared as set forth in Section 6.2.4. |
40
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
41
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
GSK. To the extent that GSK owes to IDEAYA any True Up Costs, GSK shall add such True Up Costs in its next payment due to IDEAYA pursuant to ARTICLE 7. |
6.2.6 |
Technology Transfer. Promptly following completion of the (a) WRN Program and (b) if applicable, the Option Closing Date, to the extent not previously transferred and delivered to GSK, IDEAYA shall transfer and deliver to GSK (in order to enable GSK to practice under the licenses granted to GSK under Section 8.2.1(a) and 8.1, respectively), IDEAYA Know-How and Know-How comprising Joint Arising Technology (including Materials) in its Control (including any Know-How arising from the Interim MAT2A Activities), in each case to the extent necessary to enable GSK to Develop, Manufacture and Commercialize WRN Compounds and WRN Products and, solely if the Option Closing Date occurs, the MAT2A Compounds and MAT2A Products as contemplated under this Agreement. Without limiting the foregoing, IDEAYA shall use Commercially Reasonable Efforts to facilitate orderly transition and uninterrupted Development of the applicable Licensed Compounds and Licensed Products. The format of, and media for exchanging, any of the foregoing information shall be decided by the applicable JDC. |
42
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
following the Option Closing Date, [***], (b) [***], and (c) [***], in each case in the Field and [***]. GSK shall conduct its Development and Commercialization activities in good scientific manner (as applicable) and in compliance with its Internal Policies, Applicable Law, including those regarding the environment, safety and industrial hygiene, and GMP, GLP, GCP, informed consent and Institutional Review Board regulations, current standards for pharmacovigilance practice, and all applicable requirements relating to the protection of human subjects. |
7.1.1Upfront Payment. In partial consideration of the rights and licenses granted to GSK under this Agreement, GSK shall pay IDEAYA One Hundred Million Dollars ($100,000,000) within ten (10) Business Days after the Effective Date and upon receipt of a valid invoice from IDEAYA. Such payment shall be non-creditable and non-refundable.
7.1.2Equity Investment. [On the Closing Date, GSK agrees to cause Glaxo Group Limited (the “GSK Purchaser”) to purchase for the Aggregate Purchase Price, and IDEAYA agrees to issue and sell, in a private placement pursuant to a Stock Purchase Agreement (as may be amended and/or restated from time to time, the “Purchase Agreement”), to be entered into by GSK Purchaser and IDEAYA substantially in the form set forth in Exhibit A (the “Private Placement”), the number of shares of IDEAYA’s common stock, par value $0.0001 (the “Common Stock”), determined by dividing $20,000,000 (the “Total Equity Commitment”) by a price per share equal to the Purchase Price, rounded down to the nearest number of whole shares (if applicable); provided that GSK Purchaser shall not be obligated to purchase shares of Common Stock pursuant to this Agreement or the Purchase Agreement prior to the date that is two Business
43
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Days (as defined in the Stock Purchase Agreement) after the HSR Clearance Date, or following the Termination Date; provided, further, that in the event that following the effectiveness of the Stock Purchase Agreement, the Stock Purchase Agreement is terminated prior to the Closing (as defined in the Stock Purchase Agreement) pursuant to Sections 6.12(i)-(iii) thereof, such termination shall not, unless otherwise agreed in writing by the Parties, terminate GSK Purchaser’s obligation to purchase shares of Common Stock pursuant to this Section 7.1; provided, further, that, Glaxo Group Limited shall not be obligated to purchase, and IDEAYA shall not issue or sell, in the Private Placement any shares of Common Stock which would result in the beneficial ownership of Common Stock by GSK and its affiliates (as calculated pursuant to Section 13(d) of the Exchange Act and Rule 13d-3 promulgated thereunder) of more than 9.99% of the as adjusted issued and outstanding shares of Common Stock giving effect to the Private Placement and the Public Offering (the “Beneficial Ownership Limitation”); provided, further, that any obligations of GSK or GSK Purchaser to purchase shares of Common Stock in the Private Placement pursuant to this Section 7.1 shall be deemed to be fully satisfied, and GSK and GSK Purchaser shall have no further obligation to purchase shares of Common Stock, if GSK Purchaser purchases such number of shares of Common Stock in the Private Placement so as to be in compliance with the Beneficial Ownership Limitation, regardless of whether the Aggregate Purchase Price for such shares of Common Stock is less than the Total Equity Commitment. In no event shall GSK Purchaser be obligated to purchase shares of Common Stock at an Aggregate Purchase Price exceeding the Total Equity Commitment. The Purchase Agreement shall be entered into by GSK Purchaser and IDEAYA on or about the same time as the underwriting agreement for the Public Offering is entered into by IDEAYA and the underwriters for the Public Offering.
7.3.1 |
Reports; Reconciliation Payments. Subject to Section 7.3, with respect to (a) WRN Program Costs incurred by the Parties in accordance with Section 4.2 and (b) |
44
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
WRN Development Costs and MAT2A Development Costs incurred by the Parties in accordance with Section 6.2.4 ((a) and (b) referred to collectively as the “Shared Development Costs”), within [***] days following the end of each Calendar Quarter during which any such Shared Development Costs are incurred, each of IDEAYA and GSK (as applicable), in accordance with Accounting Standards, shall submit to the Financial Working Group a written report setting forth in reasonable detail all WRN Program Costs, WRN Development Costs or MAT2A Development Costs incurred by each such Party over such Calendar Quarter, provided, however, that a preliminary estimate of the Shared Development Costs, in a format agreed by the Financial Working Group, shall be provided by each IDEAYA and GSK within [***] days following the end of the Calendar Quarter for purposes of financial statement close process. For clarity, such estimate may be based on forecasted numbers and the Parties agree that the final Development Costs and other Allowable Expenses reported in the Financial Reports may differ from this estimate. Within [***] days following the receipt by the Financial Working Group of such written reports, the Financial Working Group shall prepare and submit to each Party a written report (the “Financial Reports”) setting forth in reasonable detail (i) the calculation of all such Shared Development Costs incurred by both Parties over such Calendar Quarter and any deviations from the applicable Collaboration Budget or Development Budget, and (ii) the calculation of the net amount owed by GSK to IDEAYA or by IDEAYA to GSK in order to ensure the appropriate sharing of such Shared Development Costs in accordance with Sections 4.2 and 6.2.4. The Party that is due for reimbursement of Shared Development Costs shall invoice the other Party within [***] days of receipt of such report from the Financial Working Group. Such payments by one Party to reimburse the other Party’s expenditures for Shared Development Costs shall be paid within [***] days following receipt of the invoice. Any WRN Program Costs, WRN Development Costs or MAT2A Development Costs incurred in excess of the agreed upon Collaboration Budget or Development Budget in any Calendar Quarter will be subject to the terms set forth in Section 7.3.2. |
45
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(b)If the Financial Working Group, in consultation with the JDC, concludes that the anticipated amount of the applicable Development Costs is likely to exceed the Permitted Overage (such amount the “Excess Costs”) and there are no mitigation measures to prevent such Excess Costs, then such Excess Costs shall not be included in the calculation of the Shared Development Costs and shall be borne by the Party incurring them, unless mutually agreed by the Parties through the JSC to be shared. Notwithstanding the foregoing, to the extent that Excess Costs are directly attributable and reasonably allocable to and required by a change in Applicable Laws, a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure event, or are otherwise mutually agreed by the Parties, then such costs shall not be borne solely by the Party incurring them and shall be included in the calculation of Shared Development Costs for the purposes of determining the amounts to be paid from one Party to the other Party for the applicable Calendar Year.
(c) |
Notwithstanding the foregoing, any WRN Program Costs, WRN Development Costs or MAT2A Development Costs that are incurred by a Party as a result of that Party’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to that Party’s negligence, whether or not such WRN Program Costs, WRN Development Costs or MAT2A Development Costs are in excess of [***] of the applicable Collaboration Budget or Development Budget for the applicable Calendar Year, shall be borne entirely by that Party. |
7.4.2 |
Income Taxes. Subject to Section 7.14, income and withholding Taxes imposed on either of the Parties hereunder shall not be included in Pre-Tax Profit or Loss hereunder. |
46
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(a)If the Cost Share End Date occurs prior to the achievement of the Registration Study Initiation milestone set forth in Section 7.8 with respect to such Cost Share Opt Out Compounds and Products then GSK shall pay to IDEAYA a running royalty on Net Sales of such Cost Share Opt Out Compounds and Products by GSK, its Affiliates, and its Sublicensees in accordance with Section 7.12.
(b)If the Cost Share End Date occurs after the achievement of the Registration Study Initiation milestone set forth in Section 7.8 with respect to such Cost Share Opt Out Compounds and Products then GSK shall pay to IDEAYA a running royalty on Net Sales of such Cost Share Opt Out Compounds and Products by GSK, its Affiliates, and its Sublicensees in accordance with Section 7.12; provided that the [***] percent ([***]%), [***] percent ([***]%), [***] percent ([***]%) and [***] percent ([***]%) royalty rates set forth therein shall be [***] [***] percent ([***]%), [***] percent ([***]%), [***] percent ([***]%) and [***] percent ([***]%), respectively.
47
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Milestone Event |
POLQ Compound or POLQ Product |
WRN Compound or WRN Product
|
[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
7.8Late Stage Development and Filing Milestones. GSK shall make the non-refundable, non-creditable milestone payments to IDEAYA that are set forth below upon the first achievement by GSK, or its Affiliates or Sublicensees of the milestone events set forth below with respect to the applicable Licensed Product (“Late Stage Development and Filing Milestone”).
48
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Each milestone shall be payable only once per Major Indication per Licensed Product, up to a maximum of three (3) Major Indications per Licensed Product as set forth in the table below. For clarity, [***]. For clarity, [***] (for example, [***]).
|
POLQ Product |
||
Milestone Event |
First Major Indication |
Second Major Indication |
Third Major Indication |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
|
MAT2A Product (solely if the Option Closing Date occurs) |
||
Milestone Event |
First Major Indication |
Second Major Indication |
Third Major Indication |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
|
WRN Product |
||
Milestone Event |
First Major Indication |
Second Major Indication |
Third Major Indication |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
For the avoidance of doubt, the total amount of potential milestone payments payable under this Section 7.8 per Major Indication for each Licensed Product listed above is One Hundred Fifty Five Million Dollars ($155,000,000.00) and the total amount of potential milestone payments payable per Licensed Product if all milestones are achieved for all three (3) Major Indications ([***]) is Four Hundred Sixty Five Million Dollars ($465,000,000.00). In the event that a given Licensed Product achieves a Late Stage Development and Filing Milestone for more than one Major Indication (e.g., [***] for the treatment of both breast cancer and prostate cancer Major Indications) then all relevant preceding Late Stage Development and Filing Milestone payments for such Licensed Product shall become due and payable by GSK (e.g., the $[***] milestone payment for each of the first and second Major Indication, or, if a $[***] milestone payment was already made by GSK for a first Major Indication that was not breast cancer and prostate cancer,
49
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
then the $[***] milestone payment for each of the second and third Major Indication would become due and payable).
Milestone Event |
POLQ Product |
MAT2A Product (solely if the Option Closing Date occurs) |
WRN Product |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
[***] |
$[***] |
$[***] |
$[***] |
Milestone Event |
POLQ Products |
MAT2A Products |
WRN Products |
Net Sales in a Calendar Year are at least $[***] |
$[***] |
$[***] |
$[***] |
Net Sales in a Calendar Year are at least $[***] |
$[***] |
$[***] |
$[***] |
Net Sales in a Calendar Year are at least $[***] |
$[***] |
$[***] |
$[***] |
7.11Milestone Payment Terms. A Party achieving a milestone shall notify the other Party in writing promptly, but in no event later than [***] Business Days after each achievement of each milestone set out in Sections 7.7, 7.8, 7.9 and 7.10 that triggers a payment. GSK shall pay all such milestone payments due in Dollars [***] days after GSK’s receipt of an invoice from IDEAYA therefor following the achievement of the corresponding milestone event. Additionally, for clarity, [***]. Similarly, for clarity, [***]. Notwithstanding the foregoing, in the circumstance where [***], then the following principles shall apply: (A) [***], and (B) [***].
50
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Calendar Year Net Sales |
Royalty Rate |
For that portion of aggregate Net Sales in a Calendar Year of the applicable Licensed Product in the applicable Net Sales Territory up to and including $[***]
|
[***]% |
For that portion of aggregate Net Sales in a Calendar Year of the applicable Licensed Product in the applicable Net Sales Territory greater than $[***] up to and including $[***]
|
[***]% |
For that portion of aggregate Net Sales in a Calendar Year of the applicable Licensed Product in the applicable Net Sales Territory greater than $[***] up to and including $[***]
|
[***]% |
For that portion of aggregate Net Sales in a Calendar Year of the applicable Licensed Product in the applicable Net Sales Territory greater than $[***]
|
[***]% |
51
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
52
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
hereunder together with interest calculated in the manner provided in Section 7.16 within [***] days. If any such discrepancies are greater than [***] percent ([***]%) of the amounts actually due for the audited period, the other Party shall pay all reasonable costs incurred in conducting such review. Once a Party has conducted a review and audit of the other Party pursuant to this Section 7.13 in respect of any given period, it may not subsequently re-inspect the other Party’s records in respect of such period, unless a subsequent audit of a separate reporting period uncovers fraud on the part of the audited Party that is reasonably expected to have been occurring during the prior audited period. For clarity, however, if a discrepancy is identified by the accountant during the course of an audit and the Parties do not agree upon a resolution of such discrepancy, then the auditing Party’s accountant may re-inspect the books and records to the extent reasonably relevant to resolving such discrepancy. Unless otherwise defined or stated, financial terms shall be calculated by the accrual method under the applicable Party’s Accounting Standards. Financial records related to the foregoing shall be maintained (in such form as may be available) by each Party for a period of no less than seven (7) years following the end of the period to which they pertain. |
7.14.1 |
Any amount payable by one Party to the other under this Agreement is deemed to be exclusive of any amount in respect of any VAT chargeable on the supply for which that sum is the consideration (in whole or in part) for VAT purposes. If anything done by one Party under this Agreement constitutes, for VAT purposes, the making of a supply to the other Party and VAT is or becomes chargeable on that supply, the Party receiving the supply shall pay the other Party, in addition to any amount otherwise payable under this Agreement by the Party receiving the supply, a sum equal to the amount of the VAT chargeable on that supply against delivery of a valid VAT invoice to the Party receiving the supply. |
53
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
withholdings on the withheld amounts), the Payee receives an amount equal to the sum it would have received had no such Increased Withholding Taxes been made. |
7.14.3 |
The Parties will cooperate with respect to all documentation required by any taxing authority or reasonably requested by either Party to secure a reduction in the rate of applicable withholding Taxes or an exemption from withholding Taxes. Notwithstanding the foregoing, if a Party is entitled under any applicable tax treaty to a reduction of rate of, or the elimination of, or recovery of, applicable withholding tax, then it may deliver to the other Party or the appropriate governmental authority the prescribed forms necessary to reduce the applicable rate of withholding or to relieve the Payor of its obligation to withhold tax. If a Payee timely delivers to the Payor a validly executed form establishing a reduced rate or exemption from withholding, the Payor shall apply the reduced rate of withholding, or not withhold, as the case may be, provided that the Payor is in receipt of evidence, in a form reasonably satisfactory to the Payor. If, in accordance with the foregoing, the Payor withholds any amount, then it will pay to the Payee the balance when due, timely remit to the proper taxing authority of the withheld amount, and send the Payee proof of such remittance within [***] days following that remittance. |
7.15 |
Invoicing. To the extent an invoice is required to be submitted to GSK hereunder, such invoice shall include the information set forth in Schedule 7.15. |
7.16 |
Late Payments. Without limiting either Party’s remedies under this Agreement, any undisputed payments or portions thereof due hereunder that are not paid on the date such payments are due under this Agreement shall bear interest at a rate equal to [***] percentage points above the prime rate as published by Citibank, N.A., New York, New York, or any successor thereto, at 12:01 a.m. on the first day of each Calendar Quarter in which such payments are overdue, calculated on the number of days such payment is delinquent. Where the late payment is caused by the Party that is owed the payment, including for reasons such as failure to communicate in a timely manner changes to bank details, or failure to respond to communications from the Party owing the payment regarding the interpretation or dispute of the terms of such payment, then no interest will be payable by the Party owing the payment. |
54
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
7.19 |
Disclaimer. IDEAYA and GSK each acknowledge and agree that nothing in this Agreement will be construed as representing any estimate or projection of (i) the successful Development or Commercialization of any Licensed Product under this Agreement, (ii) if Commercialized, that any Licensed Product will achieve any particular pricing or reimbursement amount or any particular sales level, or (iii) anticipated sales or the actual value of any Licensed Product that may be successfully Developed or Commercialized under this Agreement. |
7.20 |
Cooperation on Inter-Party Structure. The Parties will reasonably cooperate to establish or facilitate an optimal inter-Party financial operational structure (including, if necessary, procedures and agreements among the various Affiliates of the Parties) which is consistent with the economic result contemplated herein, consistent to the extent feasible with each Party’s internal structures and procedures, and not adverse to the Parties financial, economic, or tax positions. |
55
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Notwithstanding any other provision of this Agreement to the contrary, the obligation to pay any reasonably disputed amount shall not be deemed to have been triggered until such dispute is resolved hereunder, provided that any undisputed portion of such payment shall be paid by the paying Party in accordance with the payment terms set forth in this Agreement. Any disputed portion of any payment shall be paid by the responsible Party within [***] days after the date on which the Financial Working Group or JSC, as applicable, resolves the dispute. |
ARTICLE 8
MAT2A Option; Licenses
56
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
8.2.2 |
IDEAYA hereby grants to GSK and its Affiliates, as of the Effective Date and solely to the extent that it is agreed in the Collaboration Plan applicable to the MAT2A Program that GSK shall conduct GSK MAT2A Preclinical Activities, a non-exclusive, royalty-free, worldwide license to IDEAYA Technology solely to the extent necessary for GSK’s performance of such GSK MAT2A Preclinical Activities under the relevant Collaboration Plan for the MAT2A Program, and for no other purpose whatsoever. The foregoing license shall expire on the earlier to occur of (a) the Option Closing Date; (b) expiration of the Option Period without exercise of the Option; or (c) completion by GSK of the GSK MAT2A Preclinical Activities under the relevant Collaboration Plan for the MAT2A Program. The foregoing license shall be sublicensable to GSK’s Affiliates and subcontractors solely to the extent such Affiliates and subcontractors are performing any of the GSK MAT2A Preclinical Activities on behalf of GSK under the relevant Collaboration Plan for the MAT2A Program. For the avoidance of doubt, the foregoing license does not include the right to conduct the MAT2A Combination Study and any license to IDEAYA Technology required for the conduct of the MAT2A Combination Study shall be as set forth in the MAT2A CTCSA. |
57
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
58
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
of (or complete access to, as appropriate) all such intellectual property (including all embodiments of such intellectual property), which, if not already in the non-bankrupt Party’s possession, shall be promptly delivered to it upon its’s written request (a) upon commencement of a bankruptcy proceeding, unless the bankrupt Party continues to perform all of its obligations under this Agreement, or (b) if not delivered pursuant to clause (a) because the bankrupt continues to perform, upon the rejection of this Agreement by or on behalf of the bankrupt Party. Unless and until the bankrupt Party rejects this Agreement, the bankrupt Party shall perform this Agreement or provide such intellectual property (including all embodiments of such intellectual property) to the non-bankrupt Party, and shall not interfere with the rights of the non-bankrupt Party to such intellectual property, including the right to obtain the intellectual property from another entity. In the case of an insolvency that is governed by non-U.S. bankruptcy law, the Parties agree that, to the extent not prohibited by the applicable insolvency law, the non-bankrupt Party will be entitled to at least the same rights and protections afforded by the U.S. Bankruptcy Code, including survival of the licenses granted hereunder even if the bankrupt Party revokes or terminates this Agreement and a copy of the embodiments of such intellectual property, without conditions other than any legally required payment of royalties. |
ARTICLE 9
CONFIDENTIALITY; Publications and Presentations
9.1.1 |
is or becomes part of the public domain through no wrongful act, fault or negligence on the part of the Receiving Party; |
9.1.2 |
can be demonstrated by competent proof to have been in the Receiving Party’s possession prior to initial disclosure by the Disclosing Party without any obligation of confidentiality with respect to such information; |
9.1.3 |
is subsequently received by the Receiving Party from a Third Party who is not bound by any obligation of confidentiality with respect to such information; |
59
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
9.1.4 |
has been published by a Third Party or otherwise enters the public domain through no fault of the Receiving Party in breach of its contractual obligations to the Disclosing Party; or |
9.1.5 |
can be demonstrated by competent proof to have been independently developed (outside the scope of this Agreement) by or for the Receiving Party without reference to or use of the Disclosing Party’s Confidential Information. |
9.2 |
Authorized Disclosure. The Receiving Party may disclose Confidential Information of the Disclosing Party to the extent that such disclosure is: |
(a) |
made in response to a valid order of a court or other governmental authority or, if in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is otherwise required by Applicable Law, including by reason of filing with securities regulators; provided that the Receiving Party shall, where practicable, first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to quash such order or to obtain a protective order or confidential treatment; and provided further that the Confidential Information disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order; |
(b) |
made by or on behalf of the Receiving Party to Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval for the Licensed Products as permitted by this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such information to the extent practicable and consistent with Applicable Law; |
(c) |
made by or on behalf of the Receiving Party to a patent authority as may be reasonably necessary or useful for purposes of obtaining a Patent as permitted by this Agreement; provided that reasonable measures shall be taken to assure confidential treatment of such information, to the extent such protection is available; or |
(d) |
made by the Receiving Party to its attorneys, auditors, advisors, consultants, contractors, existing or prospective collaboration partners, licensees, sublicensees, existing or prospective investors, prospective acquirers, prospective lenders or other Third Parties as may be necessary in connection with the performance of this Agreement, in each case, for limited purposes; provided that such persons shall be subject to obligations of confidentiality and non-use with respect to such Confidential Information substantially similar to the obligations of confidentiality and non-use of the Receiving Party set forth herein. |
60
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
of Section 15.1, the Parties agree that upon any such breach or any threat thereof, the Disclosing Party shall be entitled to seek appropriate equitable relief at the Disclosing Party’s option in either (a) a court of competent jurisdiction where such Disclosing Party resides, or (b) as provided in Section 15.1, as applicable, in addition to whatever remedies it might have at law in connection with any breach or enforcement of a Receiving Party’s obligations hereunder for the unauthorized use or release of any such Confidential Information. |
61
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
9.6.2 |
Once a publication or presentation has been approved, GSK may use the information contained in the publication or presentation without seeking further approval. |
9.6.3 |
GSK will ascribe authorship of any proposed publication using accepted standards used in peer-reviewed, academic journals at the time of the proposed publication. |
9.6.4 |
Each publication made in accordance with this Section 9.6 shall not be a breach of the confidentiality provisions contained in Section 9.1. |
9.7.1Notwithstanding anything to the contrary in Section 9.7.2, IDEAYA is responsible for, and has the sole right to, publish clinical Data from the Phase 1 MAT2A Monotherapy Study and Interim MAT2A Activities (a) at its discretion at any time prior to the Option Closing Date, and (b) as required by Applicable Law or IDEAYA’s Internal Policies,
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subject to GSK’s ability to review and delay publication solely under the circumstances specified in Section 9.6.1 applied mutatis mutandis, after the Option Closing Date.
9.7.2Notwithstanding the provisions of this ARTICLE 9, and subject to Sections 9.6 and 9.7.1, GSK shall have the right at any time during and after the Term to (a) publish the results or summaries of results of all clinical studies, observational studies and other studies such a meta analyses, conducted with respect to any and all Licensed Products in any clinical trial register maintained by GSK or its Affiliates and the protocols of such clinical studies on xxx.xxxxxxxxxxxxxx.xxx or in each case publish the results, summaries or protocols of such clinical or other studies on such other websites or repositories or at scientific congresses and in peer-reviewed journals within such timescales as required by Applicable Law or GSK’s or its Affiliate’s Internal Policies, irrespective of the outcome of such clinical studies; (b) make information from clinical or other studies conducted by or on behalf of GSK with respect to a Licensed Product available under its Data Sharing Initiative; and (c) and make any other public disclosures of clinical Data that become required of GSK due to its Internal Policies and procedures or Applicable Laws.
9.8 |
Collaboration Program Publications. Each JDC shall discuss whether to publish preclinical Data and if so agreed, the JDC will propose a publication strategy for approval by the JSC. |
INTELLECTUAL PROPERTY
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acting on behalf of GSK in the performance of activities under this Agreement (with respect to such Third Party, including the conduct of any Collaboration Program), (it being understood that any activities carried out by or on behalf of IDEAYA under this Agreement shall not be construed or interpreted to be carried out by or on behalf of GSK for purposes hereof) or (b) regardless of inventorship, in the conduct of the GSK MAT2A Preclinical Activities that relate solely to the GSK PRMT Product (such Know-How under (a) and (b), the “GSK Arising Know-How”, and such Patents under (a) and (b), the “GSK Arising Patents”), and GSK shall retain all of its right, title and interest thereto, except to the extent that any rights or licenses are expressly granted hereunder by GSK to IDEAYA under this Agreement. IDEAYA hereby assigns to GSK all of its right, title, and interest to such GSK Arising Know-How and GSK Arising Patents. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
provide all such other necessary support to such other Party in order to promptly and fully transfer such activities to the other Party. In such circumstances, the Patent Liaison for the Controlling Party relinquishing direction of the prosecution, maintenance or defense activities will still be kept reasonably informed on a regular basis by the assuming Party’s Patent Liaison regarding, and provided with reasonable opportunity to comment and consult on, all such activities in compliance with the preceding principles in this Section 10.2.1 applied mutatis mutandis. |
10.2.2 |
Patent Costs. During the Term, GSK shall pay all Patent Costs with respect to Subject Patents covering or claiming, or arising in connection with, the POLQ Program. The Parties shall share all Patent Costs as Shared Development Costs with respect to Subject Patents covering or claiming, or arising in connection with, the WRN Program during the Term until the Regulatory Approval of the first WRN Product. Following Regulatory Approval of the first WRN Product, GSK shall pay all such Patent Costs in the Net Sales Territory and the Parties shall share such Patent Costs with respect to Profit Sharing Territory as set forth in the Pre-Tax Profit or Loss Schedule. IDEAYA shall pay all Patent Costs with respect to MAT2A Patents until the Option Closing Date if GSK exercises its option to MAT2A. From and after the Option Closing Date, the Parties shall share all Patent Costs as Shared Development Costs with respect to Subject Patents covering or claiming, or arising in connection with, the MAT2A Program during the Term until the Regulatory Approval of the first MAT2A Product. Following Regulatory Approval of the first MAT2A Product, GSK shall pay all such Patent Costs in the Net Sales Territory and the Parties shall share such Patent Costs with respect to the Profit-Sharing Territory as set forth in the Pre-Tax Profit or Loss Schedule. |
10.2.4 |
Cooperation. The Party that is not the Controlling Party will cooperate with the other Party, including furnishing a power of attorney, inventor declaration or assignment documentation, to allow such preparation, prosecution, maintenance or defense activities to be carried out effectively and expeditiously. |
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under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (the “Xxxxx-Xxxxxx Act”) where a response is required under Applicable Law (in order to avoid waiving rights), such Party shall provide notice as quickly as possible and in no event later than [***] days prior to the applicable deadline for filing a response. For clarity, any certification filed under the Xxxxx-Xxxxxx Act shall constitute an Infringement for the purposes of this Agreement. |
(1)Any damages or other monetary awards recovered from the settlement of or judgment from such enforcement actions shall be allocated first to reimburse the Parties for the costs and expenses incurred by it in connection with such enforcement actions (excluding any cost of separate counsel engaged by the non-Controlling Party pursuant to the preceding sentence). Any amounts remaining will be allocated between the Parties as follows: (i) with respect to Infringement in the Profit-Sharing Territory by a Competing Product in relation to WRN Products or MAT2A Products so long as IDEAYA has not exercised the IDEAYA Opt-Out with respect to the applicable Licensed Product, then in a manner consistent with the applicable split of Pre-Tax Profit and Loss; (ii) with respect to Infringement in the Net Sales Territory by a Competing Product in relation to WRN Products or MAT2A Products, Infringement in the Profit-Sharing Territory by a Competing Product in relation to WRN Products or MAT2A Products if IDEAYA has exercised the IDEAYA Opt-Out with respect to the applicable Licensed Product, or Infringement in the Territory by a Competing Product in relation to POLQ Products, then (X) if GSK is the Controlling Party, to GSK with IDEAYA receiving a royalty on the recovery proceeds in accordance with the provisions of Section 7.12 and (Y) if IDEAYA is the Controlling Party, then [***] to IDEAYA and [***] to GSK; and (iii) with respect to Infringement in the Territory that is not by a Competing Product but against which a Joint Arising Patent is nevertheless enforced by the Controlling Party, then such amounts shall be shared equally by the Parties.
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10.3.4 |
Settlement with a Third Party. The Controlling Party that is controlling an enforcement action shall also have the right to control the settlement of such enforcement action; provided that the Controlling Party shall not settle such enforcement action in any way that imposes a monetary obligation upon the other Party or its Affiliates, or in any way that narrows the scope of, or admits the unenforceability or invalidity of Patents Controlled by the other Party or its Affiliates, or of Patents within the Joint Arising Technology, in all cases without such other Party’s prior written consent. |
10.4 |
Infringement Claims by Third Parties. |
10.4.2 |
Cooperation; Settlement. Each Party shall keep the other Party reasonably informed of all material developments in connection with any Third Party Infringement Claim through the Patent Liaisons. Such Party shall provide the other Party with copies of all filings by or correspondence from the counterparty(ies) in any suit or proceeding relating to such Third Party Infringement Claim, and with copies of proposed filings to be filed or material correspondence to be delivered to such counterparty(ies) by the Party defending such Third Party Infringement Claim in such proceedings at least [***] days prior to the anticipated filing or delivery date thereof for the other Party to comment on, and the Party defending such Third Party Infringement Claim shall take all such comments received under good faith consideration. The Party defending such Third Party Infringement Claim may enter into a settlement or compromise of any Third Party Infringement Claim, provided that, if such settlement or compromise would admit liability on the part of the other Party or any of its Affiliates or would otherwise have a material adverse effect on the rights or interests of the other Party or its Affiliates (including by imposing any monetary obligation upon the other Party or its Affiliates or by limiting the scope of or admitting the unenforceability or invalidity of Patents owned or exclusively licensed by the other Party or its Affiliates), then such Party shall not enter into such settlement or compromise without the prior written consent of the other Party. Any counterclaims of Infringement shall be handled as set forth in Section 10.3. |
10.4.3 |
Costs; Recoveries. All out-of-pocket expenses incurred by a Party in defending a Third Party Infringement Claim (including outside counsel fees), and all amounts |
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10.5 |
Orange Book. GSK will have sole decision-making authority with respect to the determination of whether or not to submit IDEAYA Existing Patents, IDEAYA Arising Patents, Patents within the Joint Arising Technology, or any GSK Patent, in each case, which Patents claim or cover a POLQ Product, WRN Product, or, and solely as of and after the Option Closing Date, if applicable, the MAT2A Product to the applicable regulatory authorities for listing in the Orange Book as required under the Xxxxx-Xxxxxx Act. |
ARTICLE 11
Term and Termination
11.1 |
Term. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this ARTICLE 11, shall remain in effect until it expires (the “Term”) as follows: |
11.2 |
Termination for Cause. In addition to any other remedies conferred by this Agreement or by Applicable Law or in equity, either Party may terminate this Agreement with |
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respect to Licensed Compounds or Licensed Products directed to a given Target on a per Target basis (e.g. POLQ, WRN, or, solely if the Option Closing Date occurs, MAT2A) if there is an uncured material breach of this Agreement by the other Party with respect to such Licensed Compounds or Licensed Products directed to such Target. To exercise its termination rights under this Section 11.2, the non-breaching Party shall provide to the breaching Party with written notice, identifying the material breach in reasonable detail and whether the non-breaching Party is intending to terminate this Agreement with respect to the applicable Licensed Compounds or Licensed Products with respect to one or more Targets. If such breaching Party, upon receiving such written notice identifying such material breach in reasonable detail, fails to cure such material breach within sixty (60) days after the date of such notice of breach is received (or if such breach is curable but cannot reasonably be cured within such sixty (60) day period, then within such reasonable period thereafter as is required to cure such breach), then this Agreement with respect to such particular Target against which the relevant Licensed Product and Licensed Compounds are directed shall terminate, unless there is a good faith dispute with respect to the existence of a material breach or whether such material breach has been cured, and if such alleged breach or failure to cure is contested in good faith by the alleged breaching Party in writing within sixty (60) days of the delivery of the breach notice, then the dispute resolution procedure pursuant to Section 15.1, may be initiated by either Party to determine whether a material breach or a failure to cure has actually occurred. If either Party so initiates the dispute resolution procedure, then the applicable cure period (and the corresponding termination of this Agreement, in whole or in part), shall be tolled until such time as the dispute is resolved pursuant to Section 15.1. |
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name, or directs a Third Party to assert, an action challenging the validity, scope, or enforceability of any Patent within the IDEAYA Technology with respect to a Target (including a Licensed Compound or Licensed Product relating to such Target) (including for clarity within the relevant Joint Arising Technology) that is then exclusively licensed to GSK under this Agreement (each, a “Patent Challenge” relating to such Target), IDEAYA may terminate this Agreement with respect to such Target (and all Licensed Compounds and Licensed Products relating to such Target) upon thirty (30) days’ written notice to GSK if GSK does not withdraw, or cause to be withdrawn, such Patent Challenge within such thirty (30) day period. Further, this Section 11.5 shall not apply to any Affiliates of GSK that first become Affiliates of GSK after the Effective Date in connection with a merger or acquisition event, where such Affiliates of GSK were already engaged in a Patent Challenge prior to such merger or acquisition event, so long as GSK causes such Patent Challenge to terminate within sixty (60) days after such merger or acquisition event. |
ARTICLE 12
Effects of Expiration or Termination
(a)License Termination. All licenses granted to GSK under this Agreement with respect to the Terminated Compounds and Terminated Products shall be terminated and of no further force and effect, except to the extent necessary to effect the transition set forth in Section 12.2(c).
(b)Summary of Activities. Within [***] days after the effective date of such termination, GSK shall provide to IDEAYA a reasonably detailed, accurate summary report of the status and results of its (and its Affiliates’ and Sublicensees’) material Development, Manufacturing and Commercialization activities directed to the Terminated Compounds and Terminated Products prior to the effective date of such termination.
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(c)Transition Assistance. Without limiting the generality of the remainder of this Section 12.2(c), the Parties shall effect a seamless, timely transition to IDEAYA or its designee of the then ongoing Development, Manufacturing and Commercialization activities and responsibilities, as applicable, with respect to the Terminated Compounds and Terminated Products in accordance with a transition plan to be negotiated in good faith by the Parties starting as soon as practical, but not later than [***] days after the effective date of termination, so long as the Parties are not in dispute over such termination or where GSK is actively curing a breach as permitted in Section 11.2. The transition plan will set out all relevant terms, including costs required to effect the transition including regarding transfer or completion of on-going clinical studies of Terminated Compounds and Terminated Products, transfer of Regulatory Filings and Regulatory Approvals, assignment or transfer of material Third Party agreements to the extent solely related to the Development, Manufacturing, distribution or Commercialization of Terminated Compounds or Terminated Products and transfer of any filings for trademarks solely relating to the Terminated Compounds or Terminated Products (“Product Marks”), timing and format for transfer of all Data related to the Terminated Compounds or Terminated Products, reasonable accommodations for the supply of Terminated Compounds and Terminated Products or transfer of existing inventory of Terminated Compounds and Terminated Products, and responsibility for prosecution, maintenance, enforcement and defense of Patents comprising Joint Arising Technology Notwithstanding anything to the contrary that may be set forth in such transition plan, GSK hereby assigns to IDEAYA all such Regulatory Filings, Regulatory Approvals, and Product Marks effective as of the effective date of such termination. Additionally, notwithstanding the foregoing, if GSK terminates the Agreement in its entirety or with respect to a Terminated Compound and Terminated Product in accordance with Section 11.3 as a result of material safety concerns that GSK in good faith determines make the further Development or Commercialization of the applicable Terminated Compound(s) and Terminated Product(s) unreasonable from a scientific, regulatory or ethical perspective, then GSK shall have no obligation to continue any on-going clinical trials of the Terminated Compounds and Terminated Products or enable a Third Party to do the same, or provide any supply of the applicable Terminated Compounds and Terminated Products for Development or Commercial purposes).
(d)License Grant to IDEAYA. Effective upon any such termination, GSK hereby grants to IDEAYA an exclusive, perpetual, irrevocable, royalty-bearing license, with the right to sublicense (through multiple tiers) under GSK Termination Technology to make, use, sell, offer for sale and import the applicable Terminated Compounds and Terminated Products in the Field in the Territory as of the effective date of such termination; provided, that if any GSK Termination Technology was in-licensed or acquired from a Third Party, and is subject to payment or other obligations to such Third Party, GSK shall disclose a description of such GSK Termination Technology and such obligations to IDEAYA in writing and such GSK Termination Technology shall be subject to the license granted in this Section 12.2(d) only to the extent IDEAYA agrees in writing to be bound by such obligations and reimburse or pay all amounts owed to such Third Party as a result of IDEAYA’s exercise of such license with respect to such GSK Termination Technology. In addition, IDEAYA shall pay to GSK a royalty during the applicable Royalty Term on Net Sales of Terminated Products by IDEAYA, its Affiliates or Sublicensees on a Terminated Product-by-Terminated Product and country-by-country basis at a rate of (i) [***] percent ([***]%) if this Agreement is terminated prior to first Clinical Dose Expansion of such Terminated Product;
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(ii) [***] percent ([***]%) if this Agreement is terminated after first Clinical Dose Expansion of any such Terminated Product but prior to First Commercial Sale of any such Terminated Product; or [***] percent ([***]%) if this Agreement is terminated after the First Commercial Sale of any such Terminated Product. For purposes of this royalty obligation, Sections 7.12, 7.13, 7.14, 7.16, 7.17, and 7.18, and applicable definitions used herein and therein shall survive with respect to this royalty obligation, adapted as appropriate, mutatis mutandis, with IDEAYA and its Affiliates and Sublicensees being the selling parties for the applicable Terminated Products subject to this royalty and related obligations.
12.3.1 |
In the event GSK has the right under Section 11.2 to terminate this Agreement in its entirety or with respect to one or more Licensed Compounds or Licensed Products as a result of IDEAYA’s uncured material breach, and GSK elects to terminate this Agreement or with respect to such applicable Licensed Compounds or Licensed Products, then all licenses granted to GSK under Sections 8.1 or 8.2, as applicable, either in their entirety (if applicable) or only with respect to such Terminated Compounds and Terminated Products, shall be terminated and of no further force and effect. |
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termination, shall remain in effect, in accordance with and subject to terms and conditions of this Agreement. |
12.6 |
Return of Confidential Information. At the written request of the Disclosing Party promptly following the termination of this Agreement, the Receiving Party shall (and shall cause its Affiliates and their respective representatives to) return to the Disclosing Party or destroy all originals of documents (in paper or electronic form) and physical materials then in its possession, and copies thereof, containing Confidential Information received from the Disclosing Party and constituting its exclusive Confidential Information, and destroy all documents and other materials that it created including any such Confidential Information; provided that the Receiving Party may retain in confidence (a) one (1) archival copy of the Confidential Information in its legal files solely to permit the Receiving Party to determine compliance with its obligations hereunder; (b) any portion of the Confidential Information of the other Party which is contained in the Receiving Party’s laboratory notebooks or automatic computer backups; (c) any portion of the Confidential Information of the other Party which a Receiving Party is required by Applicable Law to retain; and (d) any Confidential Information that the Receiving Party has the right to continue to use after the date of the Disclosing Party’s request after termination or expiration of this Agreement, as applicable. Notwithstanding the return or destruction of the documents and tangible items described above, the Parties will continue to be bound by their obligations under ARTICLE 9. |
12.8 |
Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies at equity or law shall remain available to the Parties except as agreed to otherwise herein. |
ARTICLE 13
Representations and Warranties AND Covenants
13.1 |
Mutual Representations, Warranties and Covenants. Each Party represents and warrants to the other Party as of the Execution Date and the Effective Date, that: |
13.1.1 |
such Party is duly organized, validly existing and in good standing under the Applicable Laws of the jurisdiction of its incorporation and has full corporate power and authority and legal right to enter into this Agreement and to carry out the provisions hereof; |
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13.1.2 |
such Party has the right to grant the licenses to the other Party purported to be granted pursuant to this Agreement; |
13.1.3 |
such Party has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder, and this Agreement constitutes a legal, valid and binding obligation of such Party that is enforceable against it in accordance with the terms and conditions hereof; |
13.1.4 |
such Party has received all necessary licenses and certificates with respect to facilities within such Party’s ownership or control sufficient to allow such Party to conduct the activities assigned to such Party under each Collaboration Plan, and such Party is in compliance with the requirements of such licenses and certificates; |
13.1.5 |
the execution, delivery and performance of this Agreement by such Party (a) will not constitute a default under, or conflict with, any agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, (b) violate any Applicable Law or regulation of any court, governmental body or administrative or other agency having jurisdiction over such Party; and (c) is not prohibited or limited by, and shall not result in the breach of or a default under, any provision of the certificate or articles of incorporation or bylaws of such Party; |
13.1.6 |
Except for any HSR Filings that may be required to comply with the HSR Act, it is not and will not be required to give any notice to any governmental authority or obtain any approval in connection with the execution and delivery of this Agreement; |
13.1.7 |
such Party and its Affiliates have not employed and during the Term, will not employ any Person debarred by the FDA (or subject to a similar sanction of EMA or foreign equivalent), or to its knowledge, any Person who is the subject of an FDA debarment investigation or proceeding (or similar proceeding of EMA or foreign equivalent); |
13.1.8 |
such Party and its Affiliates performing activities under this Agreement has in place or will have in place prior to its conduct of its activities under the Agreement a written agreement with its employees and other personnel it appoints to perform such activities hereunder to ensure that such Party has sufficient ownership or license rights to any Arising Technology invented, discovered, created or developed by such Party to grant the rights to the other Party as required to be granted under this Agreement; |
13.1.9 |
as relevant to this Agreement: (a) such Party did not employ child labor, forced labor, or cruel or abusive disciplinary practices in the workplace; (b) such Party did not discriminate against any workers on any ground in violation of Applicable Law (including race, religion, disability, gender, sexual orientation or gender identity); and (c) such Party paid each employee at least the minimum wage, provided each employee with all legally mandated benefits, and complies with all Applicable Laws on working hours and employment rights in the countries in which it operates; |
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13.1.11 |
such Party shall, and shall cause its Affiliates and its and their respective subcontractors and Sublicensees to, conduct all activities undertaken pursuant to this Agreement in accordance with Applicable Law. |
13.2 |
Representations, Warranties and Covenants of IDEAYA. IDEAYA represents and warrants to GSK, as of the Execution Date and the Effective Date, as follows: |
13.2.1 |
IDEAYA has the right to grant the Option to GSK as purported to be granted pursuant to this Agreement; |
13.2.2 |
IDEAYA owns or otherwise Controls the IDEAYA Existing Patents and IDEAYA Existing Know-How, and that the IDEAYA Existing Patents on Schedule 13.2.2 are solely owned by IDEAYA; |
13.2.4 |
all IDEAYA Existing Patents are existing and are not invalid or unenforceable in whole or in part; |
13.2.5 |
to IDEAYA’s knowledge, (i) no Person is infringing or threatening to infringe or misappropriating or threatening to misappropriate any IDEAYA Existing Patents or IDEAYA Existing Know-How (ii) and there are no activities by Third Parties that would constitute infringement or misappropriation of the IDEAYA Existing Patents or IDEAYA Existing Know-How; |
13.2.6 |
no claim or litigation has been brought or threatened in writing by any Person against IDEAYA alleging, and IDEAYA has no knowledge of any reasonable basis |
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for any such claim or allegation, whether or not asserted, that (a) any IDEAYA Existing Patents are invalid or unenforceable, or (b) except to the extent otherwise disclosed by IDEAYA to GSK prior to such date, the use or practice of any IDEAYA Existing Patents or IDEAYA Existing Know-How, or the disclosing, copying, making, assigning or licensing of any IDEAYA Existing Patents or IDEAYA Existing Know-How, or the exploitation of the Licensed Compounds as contemplated as of the Effective Date, does or will violate, infringe, misappropriate or otherwise conflict or interfere with, any issued valid Patent claim of any Third Party; |
13.2.7 |
all information and data provided by or on behalf of IDEAYA to GSK on or before the Effective Date in contemplation of this Agreement was and is true and accurate in all materials respects; |
13.3.1 |
GSK shall not knowingly engage in any activities that use the IDEAYA Technology in a manner that is outside the scope of the license rights granted to GSK under this Agreement; |
13.3.2 |
GSK shall not bring suit or any claim against IDEAYA asserting that IDEAYA has infringed [***] under the Collaboration Program; and |
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Applicable Law, in each case of (i) through (iii), as applicable to GSK’s operations and activities directly related to this Agreement. |
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14.2 |
Insurance. |
14.2.1 |
IDEAYA’s Insurance Obligations. IDEAYA shall maintain, at its cost, reasonable insurance against liability and other risks associated with its activities contemplated by this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are determined to be advisable by IDEAYA, based on advice from insurance professionals, for companies of similar size and with similar resources for the activities to be conducted by it under this Agreement taking into account the scope of the activities for which IDEAYA is responsible hereunder. IDEAYA shall furnish to GSK evidence of such insurance, upon request. |
14.2.2 |
GSK’s Insurance Obligations. GSK shall maintain, at its cost, insurance or self-insurance with respect to liabilities and other risks associated with its activities and obligations under this Agreement, including its indemnification obligations herein, in such amounts and on such terms as are customary for prudent practices for large companies in the pharmaceutical industry for the activities to be conducted by GSK under this Agreement. GSK shall furnish to IDEAYA evidence of such insurance or self-insurance, upon reasonable request. |
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SUBLICENSEES WILL BE LIABLE TO THE OTHER PARTY TO THIS AGREEMENT, ITS AFFILIATES OR ANY OF THEIR SUBLICENSEES, FOR ANY INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR OTHER INDIRECT DAMAGES, LOST PROFITS, LOST DATA OR COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY) OR CONTRIBUTION, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. |
15.2.1 |
Any disputes concerning the propriety of the commencement of the arbitration or the scope or applicability of this agreement to arbitrate shall be finally settled by the arbitrator(s). |
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15.2.3 |
The governing law in Section 16.1 shall govern such proceedings. The place of arbitration shall be San Francisco, California, unless otherwise agreed to by the Parties, and the language of the arbitration shall be English. |
15.2.6 |
Costs. The arbitrator(s) shall award to the prevailing Party, if any, as determined by the arbitrator(s), the prevailing Party’s cost, fees, and expenses incurred in connection with such arbitration. |
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disclose information regarding the arbitration proceeding to the same extent as it may disclose Confidential Information of the other Party under ARTICLE 9 above. |
15.2.9 |
Survivability. Any duty to arbitrate under this Agreement shall remain in effect and be enforceable after termination of this Agreement for any reason. |
MISCELLANEOUS
16.1 |
Governing Law. This Agreement and any dispute arising from the performance or breach hereof shall be governed by and construed in accordance with the laws of the State of New York, without reference to conflicts of laws principles. The Parties acknowledge that this Agreement evidences a transaction involving interstate commerce and a foreign (non-U.S.) Party. Notwithstanding the provision in the preceding sentence with respect to the applicable substantive law, any arbitration, decision, or award rendered hereunder and the validity, effect, and interpretation of the arbitration provision shall be governed by the Federal Arbitration Act. |
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If to GSK:
GlaxoSmithKline
000 X Xxxxx Xxx Xxxxx Xxxxx, Xxxxx 0
Xxx Xxxxxxxxx, XX 00000
Attn: SVP & Head R&D Business Development
With a copy (which shall not constitute notice to):
GlaxoSmithKline
000 Xxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxx XX0 0XX
Xxxxxx Xxxxxxx
Attn: VP & Head of Legal Business Development & Corporate
If to IDEAYA:
IDEAYA Biosciences, Inc.
0000 Xxxxxxxxx Xxxxx, Xxxxx 000
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Xxxxx Xxx Xxxxxxxxx, XX 00000
Attn: Legal Department
With a copy (which shall not constitute notice to):
Xxxxxx & Xxxxxxx LLP
000 Xxxxx Xxxxx
Xxxxx Xxxx, XX, 00000
Attention: [***]
16.6 |
Export Clause. Each Party acknowledges that the Applicable Laws of the United States and other Applicable Laws restrict the export and re-export of certain commodities and technical data. Each Party agrees that it will not export or re-export restricted commodities or technical data of the other Party in any form without the appropriate United States or foreign government licenses. |
16.8 |
Severability. If any provision hereof should be held invalid, illegal or unenforceable in any jurisdiction, the Parties shall negotiate in good faith a valid, legal and enforceable substitute provision that most nearly reflects the original intent of the Parties and all other provisions hereof shall remain in full force and effect in such jurisdiction and shall be liberally construed in order to carry out the intentions of the Parties hereto as nearly as may be possible. Such invalidity, illegality or unenforceability shall not affect the validity, legality or enforceability of such provision in any other jurisdiction, unless the invalid, illegal or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without such invalid provisions. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
superseded, amended, or modified by this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties hereto unless reduced to writing and signed by the respective authorized officers of both Parties. |
16.10 |
Independent Contractors. Nothing herein shall be construed to create a partnership, or any relationship of employer and employee, agent and principal, or joint venture between the Parties. Each Party is an independent contractor. Neither Party shall assume, either directly or indirectly, any liability of or for the other Party. Neither Party shall have the authority to bind or obligate the other Party, and neither Party shall represent that it has such authority. Neither Party shall report the transactions and undertakings contemplated by this Agreement as a partnership for United States federal income tax purposes unless required pursuant to a “final determination” as defined in Section 1313 of the United States Internal Revenue Code. |
16.11 |
Headings. Headings used herein are for convenience only and shall not in any way affect the construction of or be taken into consideration in interpreting this Agreement. |
16.12 |
Further Actions. Each Party shall execute, acknowledge and deliver such further instruments, and do all such other acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement. |
16.14 |
Counterparts. This Agreement may be executed and delivered (including by PDF or any other electronically transmitted signatures) in counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. |
16.15 |
No Third Party Beneficiaries. This Agreement is intended for the benefit of the Parties, their respective permitted successors and assigns, and is not for the benefit of, nor many any provision hereof be enforced by, any other Person other than with respect to the indemnification provisions in ARTICLE 14 and as otherwise expressly set forth herein. |
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
“hereof” and “hereunder”, and words of similar import, will be construed to refer to this Agreement in its entirety and not to any particular provision hereof, (e) the word “or” will be interpreted to mean “and/or”, (f) all references herein to Articles, Sections, or Exhibits, unless otherwise specifically provided, will be construed to refer to Articles, Sections, and Exhibits of this Agreement, and (g) the words “include” and “including” will be interpreted to mean “include without limitation” and “including without limitation,” respectively. |
[Signature page follows]
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed as of the Execution Date by their respective duly authorized representatives as set forth below.
GLAXOSMITHKLINE INTELLECTUAL PROPERTY (NO. 4) LIMITED
/s/ Xxxx Xxxxxx By: Xxxx Xxxxxx
Its: Director
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/s/ Xxxxxx X. Xxxx By: Xxxxxx X. Xxxx
Its: President and Chief Executive Officer
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[SIGNATURE PAGE TO COLLABORATION, OPTION AND LICENSE AGREEMENT]
OPTION DATA PACKAGE
[***]
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
COLLABORATION PLANS AND COLLABORATION BUDGETS
[***]
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
[***]
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
FORM OF MATERIAL TRANSFER RECORD
Material Transfer Record
From:[•]
To:[•]
We refer to the Collaboration Agreement dated July 24, 2018 (the “Agreement”) between [GSK] and [IDEAYA]
The Materials described below are supplied by [•] to [•] subject to the terms and conditions set out in the Agreement.
Material name |
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Material type/description |
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Amount supplied |
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Approved use |
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By:______________________________
For and on behalf of [•] as the Materials Transferring Party
______________________________
Date material sent /provided
By:______________________________
For and on behalf of [•] as the Materials Receiving Party
______________________________
Date material received
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
INVOICING and BANK DETAILS INSTRUCTIONS
A copy of all invoices in PDF format should be sent via email to Alliance Management copying the Deal Accounting and Alliances Finance department (email: [***]).
Invoice must include the following details:
For any queries in relation to invoicing, please contact Finance Analyst Deal Accounting and Alliances Finance department (email: [***]).
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a. |
IDEAYA shall provide a scan copy of a letter (on its letterhead), signed by finance and scanned into a PDF or ‘read only’ word document i.e. password protected. |
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b. |
The PDF or word file referred to above shall be sent via email to the GSK Alliance Partner and also copying the Deal Accounting and Alliances Finance department (email: [***]). |
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d. |
A verification call by GSK’s Procurement Team will be made to the supplier |
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
PRE-TAX PROFIT AND LOSS SCHEDULE
A.General Principles
Pre-Tax Profit or Loss for the Profit-Sharing Territory shall be calculated in accordance with this Schedule 7.4.1 and shall exclude capital expenditures, and any other cost not specifically included in Allowable Expenses, including, by way of example, costs attributable to general corporate activities, executive management, investor relations, treasury services, business development, corporate government relations, external financial reporting and other overhead.
Principles for Calculation of Pre-Tax Profit or Loss
2. |
No cost item shall be allocated to more than one cost category, i.e., Net Sales or Allowable Expenses (or any cost item within Net Sales (such as governmental and other rebates) or Allowable Expenses, such as Health Care Reform Fees, etc.). |
3. |
Costs incurred by GSK in connection with Commercialization shall be allocated to the appropriate category of Allowable Expenses in accordance with GSK’s customary practices for its other products. |
4. |
Where GSK incurs costs under this Agreement that apply to more than one Licensed Product as well as products or programs that are not included under this Agreement then GSK shall make an equitable allocation of such costs between all of such Licensed Products and other programs and products as applicable, in accordance with GSK’s Accounting Standards such that the applicable Licensed Product does not bear a disproportionate portion of such costs. |
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
7. |
Nothing in this Schedule 7.4.1 will apply to any Licensed Product for which the Parties are not sharing Pre-Tax Profit or Loss. |
B.Reconciliation Procedures.
1.Reporting.
(a)Reporting Generally. On a Licensed Product-by-Licensed Product basis, within [***] days after the end of each Calendar Quarter beginning with the first Calendar Quarter in which the First Commercial Sale of such Licensed Product occurs, GSK shall provide to the Financial Working Group a report of its calculation of actual Pre-Tax Profit or Loss with respect to such Licensed Product for such Calendar Quarter (each, a “Financial Report”), in such reporting format as the Financial Working Group shall mutually agree upon for use, which reporting format shall be consistent with the categories calculated by GSK in accordance with its Accounting Standards; provided that a preliminary estimate of the Pre-Tax Profit or Loss, in a format agreed by the Financial Working Group, shall be provided by GSK within [***] days following the end of the Calendar Quarter for purposes of financial statement close process and that the Financial Report of GSK’s calculation of Pre-Tax Profit or Loss for the Calendar Quarter in which the First Commercial Sale of a Licensed Product occurs will include any Allowable Expenses incurred by GSK with respect to such Licensed Product prior to such Calendar Quarter (i.e., Allowable Expenses associated with Launch Preparation Activities). Each Financial Report shall specify in reasonable detail, as applicable, the Net Sales, Other Income and Allowable Expenses for such Licensed Product in the corresponding Calendar Quarter received and incurred by GSK or any of its Affiliates or Sublicensees in accordance with this Agreement in such Calendar Quarter. If requested by IDEAYA or by the Financial Working Group, GSK will promptly provide invoices or other supporting documentation in sufficient detail to permit IDEAYA to confirm the accuracy of the reported cost. GSK will work to ensure that there will be separate invoices with respect to expenses and income so that accounting can be allocated appropriately to activities with respect to Licensed Products for sale in the Profit-Sharing Territory for purposes of calculating Pre-Tax Profit or Loss.
(b)Net Sales Reporting. Within [***] days after the end of each Calendar Quarter, GSK shall provide the Financial Working Group with a report of the Net Sales for such Calendar Quarter on a Licensed Product-by-Licensed Product basis in the Profit-Sharing Territory in the same format as provided in Section 7.12.6 of the Agreement; provided that a preliminary estimate of the Net Sales for the Calendar Quarter, in a format agreed by the Financial Working Group, shall be provided by GSK within [***] days following the end of the Calendar Quarter for purposes of financial statement close process.
(c)Estimates. For clarity, the foregoing estimates set forth in Sections B.1(a) and B.1(b) may be based on forecasted numbers and the Parties agree that the final Pre-Tax Profit or Loss or Net Sales, as applicable, reported in the Financial Reports may differ from this estimate.
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(a)GSK shall notify IDEAYA promptly after becoming aware that the anticipated Allowable Expenses to be incurred by GSK for a Licensed Product for a given Calendar Year shall be in excess of the applicable approved Commercialization Budget for such Licensed Product for such Calendar Year.
(b)Following such notification, the Financial Working Group shall discuss the causes of any such increase and evaluate potential mitigation measures to prevent a further increase of Allowable Expenses, as applicable. To the extent, based on this discussion, the Financial Working Group mutually concludes that the anticipated amount of the concerned category of Allowable Expenses is likely not to exceed [***] of the amounts budgeted (the “Commercialization Permitted Overage”) to be incurred by or on behalf of GSK for its activities for the Licensed Product in such Calendar Year as set forth in the then-current applicable Commercialization Budget, then such anticipated costs or expenses shall be included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Loss hereunder.
(c)If the Financial Working Group, in consultation with the JSC, mutually concludes that the anticipated amount of the applicable Allowable Expenses is likely to exceed the Commercialization Permitted Overage (such amount the “Commercialization Excess Costs”) and there are no mitigation measures to prevent such Commercialization Excess Costs, then such Commercialization Excess Costs shall not be included in the calculation of the applicable Allowable Expenses for the purposes of calculating the Pre-Tax Profit or Loss, unless mutually agreed by the Parties through the JSC to be shared.
(d)Notwithstanding the foregoing, any Allowable Expenses that are incurred by GSK as a result of GSK’s failure to use Commercially Reasonable Efforts in connection with performing its obligations hereunder or due to the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors, whether or not such Allowable Expenses are in excess of [***] of the applicable Commercialization Budget for the applicable Calendar Quarter, shall be borne entirely by GSK. Further, to the extent that Commercialization Excess Costs are directly attributable to and required by a change in Applicable Laws, a requirement of a Regulatory Authority, a change required to mitigate a safety issue or a Force Majeure event, or are otherwise mutually agreed by the Parties, then such Commercialization Excess Costs shall not be borne solely by GSK and shall be included in the calculation of the applicable Allowable Expenses.
3.Reconciliation and Payment.
(a)Reconciliation Discussion. If IDEAYA has any questions or concerns regarding the calculation of Pre-Tax Profit or Loss reported by GSK in a Financial Report, the Financial Working Group shall endeavor to resolve such questions and concerns within [***] days after the end of each Calendar Quarter. Additionally, the Financial Working Group may by mutual agreement adjust the timing for notification and/or payment of any reconciliation payments hereunder.
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(b)Quarterly Reconciliation Payment. Unless such timing is otherwise modified by mutual agreement of the Financial Working Group, within [***] Business Days after receipt of the Financial Report provided pursuant to Section B.1(a) above, the Financial Working Group shall confer and mutually agree in writing on a reconciliation report setting out the calculation of any payment to be paid by IDEAYA to GSK or by GSK to IDEAYA, as the case may be (in each case, the “Balancing Payment”) to effect the sharing of Pre-Tax Profit or Loss in accordance with Section 7.4.1 of the Agreement. In the event of any dispute regarding any Balancing Payment due, the Parties shall use good faith efforts to resolve the dispute provided that, if not so resolved within [***] additional Business Days, such dispute shall be resolved pursuant to Sections 7.21 and 7.22 of the Agreement. Each Party that is owed a Balancing Payment shall invoice the other Party for the amount of the Balancing Payment due and the other Party shall pay such invoiced amount within [***] days after such invoice is delivered; provided that, in the event of any dispute regarding the Balancing Payment due, the undisputed portion of such Balancing Payment shall be paid in accordance with the foregoing timetable by the applicable Party, and the remaining, disputed portion shall be paid in accordance with Sections 7.21 and 7.22 of the Agreement.
C.Financial Definitions
The following definitions, along with capitalized terms that are defined elsewhere in the Agreement, shall apply for the purposes of calculating Pre-Tax Profit or Loss. If a financial term is not defined in this Schedule 7.4.1, or elsewhere in the Agreement, then such term shall, on a Licensed Product-by-Licensed Product basis, be defined by mutual agreement of the Financial Working Group. For purposes of the following definitions, the terms “costs” and “expenses” shall mean all direct Third Party invoiced costs and Commercial FTE Costs, unless otherwise expressly provided herein. Additionally, in no event shall a particular cost or expense (i) be counted more than once as part of calculating Allowable Expenses, even if falling under more than one category of Allowable Expense hereunder or (ii) be counted separately as an Allowable Expense if otherwise already accounted for as part of determining Allowable Expenses.
“Allowable Expenses” means the sum of the following costs and expenses incurred during the Term by GSK or its Affiliates, in the conduct of Commercialization of the applicable Licensed Products for the Profit-Sharing Territory in accordance with this Agreement during the applicable Calendar Quarter, each to the extent incurred and recorded as an expense in accordance with the applicable Accounting Standards:
[***].
Allowable Expenses shall include, subject the annual Commercialization Budget, all Third Party invoiced expenses as well as Commercial FTE Costs reasonably necessary and directly attributable and reasonably allocable to the Licensed Products for sale in the Profit-Sharing Territory, either direct expenses or expenses that shall be allocated based on a percent of effort, costs driver, or other reasonable basis used in the normal course of business. Upon request by either Party, the Financial Working Group shall review the methodology used to allocate expenses in connection with the calculation of Allowable Expenses. If the Financial Working Group does not approve such methodology, the Financial Working Group shall mutually agree upon a revised methodology. Notwithstanding any other clauses in this Schedule 7.4.1, Allowable Expenses shall
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
exclude costs that result from the gross negligence or willful misconduct of GSK or its Affiliates, Sublicensees, or Third Party contractors. “Net Sales” and “Other Income” shall not include any deductions that are included in “Allowable Expenses”. No Development Cost item may also be an Allowable Expense item, and vice-versa.
“[***]” means amounts [***] to the extent consistent with GSK’s or its Affiliate’s business practices for its other products, if not deducted [***], and provided that any amounts actually [***] shall be deducted from Allowable Expenses.
“[***]” means, as applicable with respect to any period, the FTE Rate(s) for Commercialization activities other than Commercial Manufacture, multiplied by the number of FTEs directly relating to performing such Commercialization activities in accordance with the applicable Commercialization Plan under this Agreement, during such period.
“[***]” means Manufacturing Costs directly attributable and reasonably allocable to the Manufacture of a given Licensed Product (including the cost of API) for Commercialization of such Licensed Product in the Profit-Sharing Territory. “Commercial Manufacture Costs” shall not include any costs of activities conducted for supply of Licensed Products for which the Parties are not sharing Pre-Tax Profit or Loss.
“v” means costs and expenses incurred by or on behalf of GSK that are directly attributable and reasonably allocable to the [***] for sale in the Profit-Sharing Territory, including: (a) [***]; (b) [***]; (c) reasonable and customary [***]; and (d) to the extent not paid for by customers, [***], but for clarity, excluding in each case ((a) through (d)) any such amounts to the extent included as a [***]. [***] shall not exceed [***] of [***].
“[***]” means the annual fee paid to the [***] as defined in the [***] and similar [***] in the Profit-Sharing Territory to the extent directly attributable and reasonably allocable to the applicable Licensed Product and not included as a [***]. If any similar [***] is legislated or rule created in the Profit-Sharing Territory directly attributable and reasonably allocable to the applicable Licensed Product, this shall also be included as an Allowable Expense to the extent directly attributable and reasonably allocable to the applicable Licensed Product and not included as a deduction in calculating Net Sales.
“[***]” means, to the extent not included in Development Costs and not covered in the applicable Development Plan, costs incurred in the [***] of the applicable Licensed Product for sale in the Profit-Sharing Territory, and related [***], including, in each case to the extent directly attributable and reasonably allocable to such Licensed Product:
(1) [***];
(2) [***];
(3) [***] expenses directly attributable and reasonably allocable to such Licensed Product such as [***], provided that if professional staff support more than one product then their expenses shall be allocated based on a percent of effort or other reasonable basis used in the normal course of business;
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(4) [***], which means [***] supports more than one product, then the expenses shall be allocated based on a percent of effort or other reasonable basis used in the normal course of business;
(5) [***], which means [***] directly attributable and reasonably allocable to a Licensed Product for sale in the Profit-Sharing Territory; provided that, if employees provide this service, then such employees’ Commercial FTE Costs; provided further that if an employee supports more than one product, then the Commercial FTE Costs shall be allocated based on a percent of effort or other reasonable basis used in the normal course of business; and
(6) [***], which means expenses reasonably necessary and directly attributable and reasonably allocable to the applicable Licensed Product, such as [***] directly attributable and reasonably allocable to such Licensed Product.
[***] will specifically exclude the costs of activities to the extent such activities promote (a) [***], (b) products other than the Licensed Products for sale in the Profit-Sharing Territory, or (c) Licensed Products outside the Profit-Sharing Territory.
“[***]” means expenses reasonably necessary and directly attributable and reasonably allocable to the Licensed Products for sale in the Profit-Sharing Territory or allocated on a percent of effort or other reasonable basis used in the normal course of business, [***].
“[***]” means any payment, income, or other consideration (other than Net Sales) received by GSK or its Affiliates from a Third Party [***], and any payment, income, or other consideration received pursuant to [***] of the Agreement consistent with [***] of the Agreement.
“[***]” means a [***] that is subject to sharing of Pre-Tax Profit or Loss for which IDEAYA has not exercised the IDEAYA Opt-Out, [***].
“[***]” means, to the extent not subject to GSK’s indemnification obligations under this Agreement, expenses directly attributable and reasonably allocable to the v a Licensed Product in the Profit-Sharing Territory, v Licensed Product, [***] Licensed Product and [***] Licensed Product, in each case incurred with respect to a [***]; provided that [***]. For clarity, [***] shall exclude expenses associated with any [***] Manufacture of the Licensed Product.
“[***]” means, with respect to a Licensed Product for which Regulatory Approval has been obtained in the Profit-Sharing Territory, [***] to the extent directly attributable and reasonably allocable to such Licensed Product in the Profit-Sharing Territory, including Third Party invoiced costs and Commercial FTE Costs of personnel, or if personnel support more than one product, then the expenses shall be allocated based on a percent of effort or other reasonable basis used in the normal course of business, consultants and agents engaged in the maintenance of Regulatory Approvals or in activities relating to obtaining and maintaining pricing or reimbursement approvals, and costs to establish, maintain and enforce the Product Marks associated with such Licensed Products the Profit-Sharing Territory.
“[***]” means, with respect to the applicable Licensed Product in the Profit-Sharing Territory:
(1) [***].
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
(2) [***] and directly attributable and reasonably allocable to such Licensed Product, allocated on a [***], directly attributable and reasonably allocable to the [***].
“[***]” means, to the extent not subject to GSK’s or IDEAYA’s [***] under this Agreement, amounts paid to Third Parties by GSK or its Affiliates (including [***], excluding any such amounts attributable to [***], which amounts will be borne solely by GSK.
“v” means out-of-pocket expenses incurred by either Party or its Affiliates in [***] specifically relating to a Licensed Product for sale in the Profit-Sharing Territory, and amounts payable by either Party or its Affiliates as a [***].
“[***]” means any and all [***] payments made by GSK or its Affiliates to any Third Party with respect to [***] by Third Parties that GSK reasonably determines, after [***] of performing Commercial Manufacture or other Commercialization of a Licensed Product in the Profit-Sharing Territory.
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
Form of Press Release
IDEAYA and GSK Announce a Broad Partnership in Synthetic Lethality, an Emerging Field in Precision Medicine Oncology
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Partnership covers three IDEAYA Synthetic Lethality programs - MAT2A, Pol Theta and Xxxxxx Helicase, and will explore combinations between IDEAYA and GSK programs |
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IDEAYA will receive a $100 million upfront cash payment, and $20 million equity purchase of IDEAYA common stock in a direct private placement, and a potential $50 million cash option exercise fee for the MAT2A program. IDEAYA is also entitled to receive potential preclinical, clinical and sales milestones |
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IDEAYA will receive a 50% US profit share for the MAT2A and Xxxxxx Helicase programs and is responsible for 20% of global development costs for products being developed with XXX |
Xxxxx Xxx Xxxxxxxxx, XX, xxx Xxxxxx, Xxxxxx Xxxxxxx, June 16, 2020 – IDEAYA Biosciences, Inc. (Nasdaq: IDYA) and GlaxoSmithKline plc (GSK) announce a strategic partnership in Synthetic Lethality, an emerging field in Oncology.
The strategic partnership includes IDEAYA’s Synthetic Lethality programs MAT2A, Pol Theta, and Xxxxxx Helicase programs, which are projected to reach clinical trials within the next three years. IDEAYA has solved the crystal structures for each of its MAT2A, Pol Theta and Xxxxxx Helicase programs, enabling structure-based drug design, and has demonstrated in vivo proof of concept in relevant animal models for its MAT2A and Pol Theta programs.
Synthetic Lethality is one of four core research focus areas for GSK in oncology. In synthetic lethality, cells tolerate the loss of single genes in isolation but not together in combination. When tumor suppressor genes are functionally lost in cancer, this mode of action can be used to exploit tumor-specific vulnerabilities through new medicines for patients with cancer.
“GSK is the ideal strategic partner for IDEAYA, as this partnership enables compelling potential combinations and the opportunity to build the industry leading Synthetic Lethality pipeline that targets molecularly defined populations in several major solid tumors, including potentially lung, prostate, breast, colorectal, and ovarian cancer,” said Xxxxxx X. Xxxx, Chief Executive Officer and President, IDEAYA Biosciences.
IDEAYA will lead the MAT2A program through early clinical development. IDEAYA is responsible for all costs of the MAT2A program prior to the GSK option exercise. Thereafter, IDEAYA is responsible for 20% of global development costs.
IDEAYA will receive a 50% US profit share and ex-US royalties for the MAT2A and Xxxxxx Helicase programs and is responsible for 20% of global development costs for licensed products being developed with GSK. IDEAYA will receive global royalties for the Pol Theta program, and GSK will cover all research,
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
development, and commercialization costs. GSK will be responsible for all commercialization activities and costs globally for licensed products. The collaboration agreement is conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Xxxx-Xxxxx-Xxxxxx Act.
“GSK and IDEAYA have a vision to bring the next generation of innovative precision medicine therapies to patients utilizing the approach of Synthetic Lethality, and a highly complementary pipeline that has the potential to deliver transformative benefit for patients,” said Xxxxxxx Xxxxxx, Ph.D., Chief Scientific Officer, IDEAYA Biosciences.
IDEAYA Conference Call
At 5:00 a.m. Pacific Time / 8:00 a.m. Eastern Time today, IDEAYA's management will host a conference call and a simultaneous webcast presentation to discuss the transaction. The webcast presentation call can be accessed during the call by visiting the “Investors / News and Events / Presentation” section of IDEAYA’s website at xxx.xxxxxxxxx.xxx. Please connect to the website prior to the start of the call to allow adequate time for any software download that may be required. A replay of the webcast will be available through approximately fourteen days following the live presentation webcast.
About IDEAYA Biosciences
IDEAYA is an oncology-focused precision medicine company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA’s approach integrates capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the targeted therapies IDEAYA is developing. IDEAYA is applying these capabilities across multiple classes of precision medicine, including direct targeting of oncogenic pathways and synthetic lethality – which represents an emerging class of precision medicine targets.
___________________
About GSK in Oncology
GSK is focused on maximising patient survival through transformational medicines. GSK’s pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.
About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit xxx.xxx.xxx/xxxxx-xx.
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Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) the potential for cash payments related to MAT2A program option exercise and preclinical, clinical and sales milestones, (ii) the potential clinical combination of IDEAYA and GSK programs, (iii) the timing of IDEAYA’s Synthetic Lethality programs reaching clinical trials, (iv) the potential for an industry leading pipeline and potential solid tumor types to be addressed, and (v) the ability to deliver transformative value to patients. Such forward-looking statements involve substantial risks and uncertainties that could
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
cause IDEAYA’s preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA’s programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes including Xxxx Xxxxx Xxxxxx Antitrust Improvements Act clearance, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA’s ability to successfully establish, protect and defend its intellectual property, the effects on IDEAYA’s business of the worldwide COVID-19 pandemic, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA’s recent Quarterly Report on Form 10-Q filed on May 12, 2020 and any current and periodic reports filed with the U.S. Securities and Exchange Commission.
Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.
Registered in England & Wales:
No. 3888792
Registered Office:
000 Xxxxx Xxxx Xxxx
Xxxxxxxxx, Xxxxxxxxx
XX0 0XX
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Investor and Media Contact
IDEAYA Biosciences
Xxxx Xxxxx
Chief Financial Officer
xxxxxxxx@xxxxxxxxx.xxx
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[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
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Xxxx XxXxxxxxxx |
x0 000 000 0000 |
(Philadelphia) |
|
Xxxxxxx XxXxxxxx |
x0 000 000 0000 |
(Philadelphia) |
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
IDEAYA Existing Patents
[***]
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.
EXHIBIT A
PRIVATE PLACEMENT
[Form of stock purchase agreement]
[***]
Omitted pursuant to Regulation S-K, Item 601(a)(5)
[***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed.