Exhibit 10.20
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (1) NOT MATERIAL AND (2) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Execution Copy
EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (this “Agreement”) is entered into as of December 9, 2022 (the “Effective Date”) by and between Novartis Pharma AG (“Novartis”), a corporation organized and existing under the laws of Switzerland, and Erasca, Inc., a corporation incorporated under the laws of the State of Delaware (“Erasca”). Erasca and Novartis are sometimes referred to herein individually as a “Party” and collectively as the “Parties”.
RECITALS
WHEREAS, Novartis and its Affiliates (as defined below) have conducted clinical trials of, and Control (as defined below) certain rights to patents and other intellectual property related to, a compound known as naporafenib (LXH254) for the treatment of cancer;
WHEREAS, Novartis and its Affiliates have conducted clinical trials of, and Control (as defined below) certain rights to, patents and other intellectual property relating to other Novartis Proprietary Compounds (defined below), some of which have the potential to be used as concomitant or sequential treatments with naporafenib (LXH254) for the treatment of cancer; and
WHEREAS, Erasca desires to license the intellectual property rights associated with naporafenib (LXH254) from Novartis to Develop and Commercialize (as defined below) the Licensed Compound and Licensed Products (as defined below), and Novartis desires to grant such license to Erasca, in accordance with the terms and conditions of this Agreement, and for the avoidance of doubt, Novartis does not grant to Erasca under this Agreement any right to any Novartis Proprietary Compound other than as may be required by Law to label and promote the Licensed Compound or Licensed Products as concomitant or sequential treatments with such Novartis Proprietary Compounds.
NOW, THEREFORE, in consideration of the premises and the mutual promises and covenants contained in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereto agree as follows:
DEFINITIONS
All references to particular Exhibits, Articles, or Sections shall mean the Exhibits to, and Articles and Sections of this Agreement, unless otherwise specified. For the purposes of this Agreement and the Exhibits hereto, the following words and phrases shall have the following meanings:
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(a) Erasca ceases to function as a going concern by suspending or discontinuing its business;
(b) Erasca is the subject of voluntary or involuntary bankruptcy proceedings instituted on behalf of or against Erasca (except for involuntary bankruptcy proceedings that are dismissed within 90 days);
(c) an administrative receiver, receiver and manager, interim receiver, custodian, sequestrator, or similar officer is appointed for Erasca; or
(d) Erasca makes any general assignment for the benefit of all of its creditors.
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[***]
With respect to the calculation of Net Sales: (1) Net Sales only include the value charged or invoiced on the first arm’s length sale to a Third Party; (2) Net Sales between or among the Selling Parties shall be disregarded for purposes of calculating Net Sales; (3) if a Licensed Product is delivered to the Third Party before being invoiced (or is not invoiced), Net Sales will be calculated at the time the revenue recognition criteria under the relevant Accounting Standards are met; and (4) in the event that the Licensed Product is sold in a Combination Product (defined below), the Net Sales will be calculated by multiplying the Net Sales of the Combination Product by the fraction, A/(A+B) where A is the weighted (by sales volume) average Net Sale price in the relevant country of the Licensed Product containing the Licensed Compound as the sole active ingredient in finished form, and B is the weighted average Net Sale price (by sales volume) in that country of the product(s) containing the other component(s) as the sole active ingredient(s) in finished form. Regarding prices comprised in the weighted average Net Sale price when sold separately referred to above, if these are available for different dosages from the dosages of Licensed Compound and other active ingredient components that are included in the Combination Product, then Erasca (or its Affiliate or Sublicensee, as applicable) shall be entitled to make a proportional adjustment to such prices in calculating the Net Sales of the Combination Product. If the weighted average Net Sale price cannot be determined for the Licensed Product or other product(s) containing the single Licensed Compound or component(s), the calculation of Net Sales for Combination Products will be agreed by the Parties based on the relative value contributed by each component (each Party’s agreement not to be unreasonably withheld or delayed). For the purpose of this definition, a “Combination Product” means a Combination Therapy in which Licensed Product is sold in a finished, fixed dose form containing the Licensed Compound in combination with one or more Other Active Ingredients.
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LICENSE GRANT
[***]. For clarity, (a) Novartis has not granted Erasca, its Affiliates, or their Sublicensees a license under the Licensed Technology or Blocking Patents to make, use, sell, or offer to sell any Novartis Proprietary Compound, including any Novartis Proprietary Compound that may be included in a Combination Therapy; and (b) Novartis’ grant of rights to Licensed Technology associated with Novartis Proprietary Compounds only allows Erasca, its Affiliates, and their Sublicensees to label a Licensed Product for therapeutic use in combination with the relevant Novartis Proprietary Compound as concomitant or sequential treatments and promote such use, and this license does not grant Erasca, its Affiliates, or their Sublicensees the right to make, use, sell, or offer to sell any Novartis Proprietary Compound or pharmaceutical product containing any Novartis Proprietary Compound, or to use any Novartis trademark, except to the extent required by applicable Law or to be disclosed to any Governmental Authority. Any promotional materials for any Novartis Proprietary Compound (e.g., as a concomitant or sequential treatment with the Licensed Compound and/or Licensed Products) will be subject to Novartis’ consent and approval, which will not be unreasonably withheld, delayed or conditioned. Except to the extent required by applicable Law or to be disclosed to any Governmental Authority, any other use of a Novartis trademark will be subject to the negotiation and execution of a separate trademark license or similar agreement, on mutually acceptable terms, prior to such trademark use.
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PAYMENTS
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Milestone No. | Regulatory Milestone Event | Regulatory Milestone Payment |
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[***] | [***] | [***] |
[***] | [***] | [***] |
[***] | [***] | [***] |
[***] | [***] | [***] |
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Commercial Milestone Event | Commercial Milestone Payment | |
[***] | [***] |
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[***] | [***] |
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PATENT PROSECUTION, MAINTENANCE AND INFRINGEMENT
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TECHNOLOGY TRANSFER, DEVELOPMENT AND COMMERCIALIZATION
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(a) Novartis will share with Erasca all material safety data sheets and customs value information in Novartis’ possession or Control (that is readily located after reasonable inquiry, and has not previously been provided to Erasca), including without limitation Licensed Compound-specific information, as is reasonably necessary to permit Erasca to pick up the Material;
(b) Erasca will be solely responsible for any re-testing associated with the Material prior to use;
(c) with respect to the released clinical study Material, Novartis will provide or have provided to Erasca the certificate of analysis associated with its release and, where relevant,
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the certificate of compliance and a statement signed by a Responsible Person certifying that the batch of Licensed Product has been manufactured, including packaging and quality control, as appropriate, in full compliance with the Swiss cGMP requirements and with the specifications;
(d) unless Novartis otherwise agrees in writing, each shipment of a category of Material (e.g., reference samples, previously released GMP clinical batches (including drug substance, bulk and unlabeled primary packed drug product, and clinical bulk product), and stability samples and other items on Exhibit F) to be delivered to Erasca or a vendor engaged by Erasca will be picked up in not more than two installments per category at each location where such Materials are stored unless otherwise agreed by the Parties; and
(e) the Material made available by Novartis will only be used according to any applicable specifications, especially release specifications, and in accordance with Laws and after delivery to Erasca thereof Novartis will have no further obligation to replace lost or damaged Material or to provide additional services with respect to such Material.
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REPRESENTATIONS AND WARRANTIES
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INDEMNIFICATION
provided, however, that Erasca will not be obliged to so indemnify, defend and hold harmless a Novartis Indemnified Party for any Claims for which Novartis has an obligation to indemnify Erasca Indemnitees pursuant to Section 7.2 or to the extent that such Claims arise from the breach, negligence or willful misconduct of Novartis or a Novartis Indemnified Party.
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provided, however, that Novartis will not be obliged to so indemnify, defend and hold harmless the Erasca Indemnitees for any Claims for which Erasca has an obligation to indemnify Novartis Indemnified Parties pursuant to Section 7.1 or to the extent that such Claims arise from the breach, negligence or willful misconduct of the Erasca Indemnitees.
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CONFIDENTIALITY
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TERM AND TERMINATION
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MISCELLANEOUS
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If to Erasca:
Erasca, Inc.
3115 Merryfield Row, Suite 300
San Diego, CA 92121
Attention: Chief Executive Officer
With a copy to: General Counsel
With a copy, which shall not constitute notice to:
Latham & Watkins
12670 High Bluff Drive
San Diego, CA 92130
Fax: 858-523-5450
Attention: [***]
If to Novartis:
Novartis Pharma AG
Lichtstrasse 35
CH-4056 Basel
Switzerland
Attn: Head NIBR Legal, Europe
With a required copy to:
Novartis Institutes for BioMedical Research, Inc.
250 Massachusetts Avenue
Cambridge, MA 02139 USA
Attn: General Counsel
And by e-mail to: [***]
With a copy, which shall not constitute notice to:
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Arnold & Porter Kaye Scholer LLP
250 W 55th St
New York, NY 10019
Attention: [***]
And by e-mail to: [***] and [***]
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[Signature page follows]
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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.
ERASCA, INC.
By: /s/ Jonathan Lim, M.D.
Name: Jonathan Lim, M.D.
Title: Chairman and CEO
NOVARTIS PHARMA AG
By: [***]
Name: [***]
Title: [***]
By: [***]
Name: [***]
Title: [***]
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