Selected Product License Agreement (AB-202), dated March 24, 2021, by and between the Registrant and Green Cross LabCell Corporation
CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL.
SELECTED PRODUCT LICENSE AGREEMENT (AB-202)
THIS SELECTED PRODUCT LICENSE AGREEMENT (the Agreement) is made and entered into as of March 24, 2021 (the Effective Date) by and between ARTIVA BIOTHERAPEUTICS, INC., a Delaware corporation (Artiva), having a place of business at 4747 Executive Drive, Suite 1150, San Diego, CA 92121, USA, and GREEN CROSS LABCELL CORPORATION, a Korean corporation (GCLC), with its principal place of business at 107, Ihyeon-ro 30 beon-gil, Giheung-gu, Yongin-si, Gyeonggi-do, 446-850, 16924, Republic of Korea. Artiva and GCLC are sometimes referred to herein individually as a Party and collectively as the Parties.
A. The Parties have previously entered into that certain Option and License Agreement, dated as of September 4, 2019 (as may be amended, the Option Agreement), pursuant to which, among other things, GCLC has granted to Artiva an exclusive option to obtain an exclusive license under Selected Product Technology to develop, manufacture and commercialize Selected Products in the Field in the Territory (each term as defined in the Option Agreement) (the Option).
B. Artiva has exercised its Option with respect to the Product in accordance with the terms and conditions of the Option Agreement, and GCLC has granted to Artiva the Selected Product License (as defined in the Option Agreement) as to the Product.
C. In accordance with Section 5.3 of the Option Agreement, the Parties desire to enter into this Agreement to set forth additional terms and conditions of the Selected Product License as to the Product.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the Parties agree as follows:
Capitalized terms used in this Agreement (other than the headings of the Sections or Articles) have the following meanings set forth in this Article 1, or, if not listed in this Article 1, the meanings as designated in the text of this Agreement. Capitalized terms used in this Agreement but not otherwise defined herein shall have such meanings ascribed to them in the Option Agreement.
1.1 Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.
1.2 Existing Third Party Agreements means the following Agreements to which GCLC is a party with the following Third Parties that relate to NK Cells, Licensed Products or Information or Patents related to NK Cells or Licensed Products: [***].
1.3 GCLC Subsidiary means any Affiliate of GCLC that is directly controlled by GCLC, or over which GCLC has the power to direct or cause the direction of the management and policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting stock of such entity, or by contract.
1.4 IND shall mean an investigational new drug application, clinical trial application, clinical trial exemption, or similar application or submission filed with or submitted to a Regulatory Authority in a jurisdiction that is necessary to commence human clinical trials in such jurisdiction, including any such application filed with the FDA pursuant to 21 C.F.R. Part 312.
1.5 IND Acceptance means (a) with respect to an IND for a Product filed with the FDA, either (i) a may proceed letter from the FDA in writing in response to a dossier submitted to the FDA; or (ii) expiration of the thirty (30) day period following the date of submission of an IND without receipt of notice from the FDA within such time period that the IND is subject to a clinical hold, whichever event ((i) or (ii)) occurs first, or (b) equivalent authorization to proceed with respect to an IND filed with or submitted to any Regulatory Authority outside the United States.
1.6 Indication means a human disease, disorder or medical condition that is [***].
1.7 Initiation of a clinical trial means the first dosing of the first subject enrolled in such clinical trial.
1.8 Net Sales means, with respect to a given period of time, the gross amount invoiced by Artiva and its Affiliates and Sublicensees (each, a Selling Party) to Third Party (other than any Selling Party) purchasers for the sale or distribution of Products in the Territory, less the following deductions and offsets that are actually incurred, allowed, accrued, paid or taken and are allocated with respect to such sale or distribution:
(f) [***]; and
Such amounts shall be determined in accordance with GAAP.
With respect to (c) above, (i) no deductions will be made for commissions paid to individuals whether they be with independent sales agencies or regularly employed by Licensee and on its payroll, or for cost of collections, and (ii) if a Product is distributed at a discounted price that is substantially lower than the customary price charged by Licensee, or distributed for non-cash consideration (whether or not at a discount), Net Sales will be calculated based on the non-discounted amount of the Product charged to an independent Third Party during the same calendar quarter or, in the absence of such sales, on the fair market value of the Product.
Sales of Products by a Selling Party to another Selling Party for resale by such entity to a Third Party (other than a Selling Party) shall not be deemed a sale for purposes of this definition of Net Sales, provided that the subsequent resale is included in the computation of Net Sales. Transfers or dispositions of Products as free promotional samples in commercially reasonable amounts, consistent with prevailing industry standards, and Products used in research, development or regulatory activities, compassionate use, indigent programs, investigator-initiated trials or on a named patient basis shall be disregarded in determining Net Sales.
If any discounts or other deductions or rebates are made in connection with sales of a Product that is bundled or sold together with other products of the Selling Parties, then the discount, deduction or rebate applied to the Product shall not exceed the discount, deduction or rebate applied to any of the other products of the Selling Parties in such arrangement based upon the respective list prices of the Product and such other products prior to applying the discount, unless Artiva provides evidence reasonably satisfactory to GCLC that such difference is commercially reasonable and does not unfairly prejudice the Product in favor of such other products.
For Products which are sold as Combination Products, the Net Sales for such Combination Products shall be adjusted by [***]
1.9 Phase 2 Clinical Trial means a study of a Product in human patients designed or intended to determine initial efficacy, pharmacological effect or dose range or regimen, as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or the corresponding regulations in any jurisdiction or country other than the United States, or any amended or successor regulations, to permit the design of further clinical trials, including a human clinical trial that is also designed to satisfy the requirements of 21 C.F.R. 312.21(a) (or corresponding foreign regulations) and is subsequently optimized or expanded to satisfy the requirements of 21 C.F.R. 312.21(b) (or corresponding foreign regulations) or otherwise to enable a Pivotal Clinical Trial (e.g., a phase 1/2 trial) but only at the time of Initiation of the optimized or expanded portion of such trial.
1.10 Pivotal Clinical Trial means a pivotal study in human patients with a defined dose or a set of defined doses of the Product designed or intended to ascertain efficacy and safety of the Product for the purpose of enabling the preparation and forming the primary basis for submission of a BLA for the Product to the competent Regulatory Authority in a country of the Territory, which may be a Phase 3 study as further defined in 21 C.F.R. 312.21(c), as amended from time to time, or a Phase 2 study as further defined in 21 C.F.R. 312.21(b), as amended from time to time, or in each case defined in the corresponding regulations in any jurisdiction or country other than the United States, or any amended or successor regulations.
1.12 Product means the Licensed Product described in Exhibit 1.11 and any Combination Product of such Licensed Product.
1.13 Product Know-How means all Information Controlled by GCLC or any GCLC Subsidiary as of the Effective Date or during the Term that relate specifically to the Product or its manufacture or use (and are not otherwise included in GCLC Core Technology). Product Know-How excludes any Additional Joint Inventions.
1.14 Product Patents means any Patents in the Territory Controlled by GCLC or any GCLC Subsidiary as of the Effective Date or during the Term that relate specifically to a Product or its manufacture or use (and are not otherwise included in GCLC Core Technology). Exhibit 1.14 sets forth the Product Patents existing on the Effective Date. Exhibit 1.14 may be updated from time-to-time during the Term upon the mutual written agreement of the Parties. Product Patents excludes any Additional Joint Patents.
1.15 Product Technology means the Product Know-How and Product Patents.
1.16 Sublicensee means a Third Party to whom Artiva grants a sublicense under some or all of the rights granted to Artiva pursuant to any Product License, beyond the mere right to purchase Products from or to provide services on behalf of Artiva and its Affiliates. In no event shall GCLC or any of its Affiliates be deemed a Sublicensee.
1.17 Territory means all countries in the world, excluding Asia, Australia and New Zealand.
1.18 Additional Definitions. Each of the following definitions is set forth in the section of the Agreement indicated below:
|Additional Joint Inventions||4.1|
|Additional Joint Patents||4.1|
|Product Royalty Term||3.2(b)|
|Third Party License||3.2(e)(ii)|
2. LICENSES AND RELATED RIGHTS
2.1 License Grant. Subject to the terms and conditions of this Agreement, GCLC hereby grants Artiva during the Term an exclusive (even as to GCLC and GCLC Subsidiaries), royalty-bearing license, with the right to sublicense through multiple tiers as provided in Section 2.2, under the Product Technology, and GCLCs interest in Additional Joint Inventions and Additional Joint Patents, to research, develop, make, have made, use, offer for sale, sell and import Products in the Field and in the Territory (the Product License).
2.2 Sublicensing; Subcontracting. Artiva shall have the right to grant sublicenses of rights granted under the Product License, or subcontract its activities with respect to any Product, to its Affiliates, contractors and any other Third Party, provided that: (a) Artiva shall remain responsible for the performance or failure to perform by any such Affiliate, Sublicensee and subcontractor under their respective sublicensed or subcontracted rights or obligations to the same extent as if such activity were performed (or was failed to be performed) by Artiva; and (b) each such sublicense and subcontract agreement shall be consistent with the terms and conditions of this Agreement. Artiva shall provide GCLC with a copy of any sublicense agreement entered into with a Sublicensee, and any amendment thereto, within [***] days of its execution (provided that Artiva may redact any confidential information contained therein that is not necessary to disclose to ensure compliance with this Agreement). Artiva shall provide GCLC with a list of any subcontract agreements entered into with a subcontractor for contract research or contract manufacturing services in a calendar quarter within [***] days of the end of such calendar quarter, and if requested by GCLC within [***] days of GCLCs receipt of such list, provide GCLC with a copy of any such subcontract agreement (provided that Artiva may redact any confidential information contained therein that is not necessary to disclose to ensure compliance with this Agreement).
2.3 Reserved Rights. GCLC hereby expressly reserves all rights, interests and benefits not expressly granted to Artiva herein, including, without limitation, (a) all rights to practice, and to grant licenses under, the Product Technology and GCLCs interest in Additional Joint Inventions and Additional Joint Patents outside the Territory, and (b) the right to conduct research and development to be conducted by GCLC or any GCLC Affiliate as contemplated by this Agreement and any services or manufacturing agreements entered into between GCLC or any GCLC Affiliate and Artiva.
2.4 Negative Covenant. Artiva covenants that it will not and will not permit any of its Affiliates, Sublicensees or subcontractors to use or practice any Product Technology or GCLCs interest in Additional Joint Inventions and Additional Joint Patents outside the scope of the Product License. GCLC covenants that it will not and will not permit any of its Affiliates, or grant the right to or assist or collaborate with any Third Party, to directly or indirectly during the Term research, develop, make, have made, use, offer for sale, sell and import any Product in the Field in the Territory, except as expressly authorized in this Agreement.
2.5 No Implied Licenses. Except as explicitly set forth in this Agreement, any other Selected Product License Agreement(s) and the Option Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party.
2.6 Disclosure of Product Know-How. Within [***] days after the Effective Date, GCLC shall disclose to Artiva the Product Know-How existing as of the Effective Date. In addition, GCLC shall disclose to Artiva any Product Know-How as it pertains specifically to the Product that comes into existence after the Effective Date and was not previously provided to Artiva promptly after the development thereof (and at least every [***] months). During the Term, GCLC shall make available to Artiva, on a reasonable consultation basis, such advice of its technical personnel as may be reasonably requested by Artiva in connection with such transfer of Product Know-How.
2.7 Development Option. If GCLC desires to pursue development of a Product in combination with an antigen-specific therapy that Artiva has determined not to pursue, the Parties shall discuss in good faith and agree on a co-development arrangement for such Product in combination with an antigen-specific therapy in mutually agreed Indications in the Territory, which shall not overlap with Indications for which Artiva is developing a Product.
3.1 Initial Payment. Artiva shall pay to GCLC an upfront payment in the aggregate amount of [***] comprising: (1) the first installment in the amount of [***], which shall be due and payable to GCLC within [***] days after the Effective Date; and (ii) the second installment in the amount [***] representing [***].
3.2 Product License Royalty Payments.
(a) Product License Royalty Rates. Artiva shall pay to GCLC royalties on Net Sales of Products, the manufacture, use or sale of which are claimed by or use any Product Technology, on a country-by-country and Product-by-Product basis during the Product Royalty Term, as calculated by multiplying the applicable portion of aggregate Net Sales of the Product in the Territory by the corresponding royalty rate, as set forth in the table below, subject to the applicable adjustments in accordance with Section 3.2(e) below (the Product Royalties).
For that portion of annual aggregate Net Sales of the Product less than or equal to $[***]
For that portion of annual aggregate Net Sales of the Product greater than $[***]
(b) Product Royalty Term. Royalties payable under Section 3.2(a) shall be payable on a Product-by-Product and country-by-country basis in the Territory during the period commencing on the First Commercial Sale of such Product in such country in the Territory and continuing until the later of (i) expiration of the last-to-expire Valid Claim of the Product Patents in the country of sale claiming such Product or the manufacture or use of such Product; (ii) expiration of any Regulatory Exclusivity for such Product in such country; and (iii) the tenth (10th) anniversary of the First Commercial Sale of such Product in such country (the Product Royalty Term). Following expiration of the Product Royalty Term for any Product in a given country, no further Product Royalties shall be payable for such Product in such country, and the Product License granted to Artiva under Section 2.1 with respect to such Product in such country shall automatically become fully paid-up, perpetual and royalty-free and shall survive any expiration or termination of this Agreement.
(c) Royalty Reports and Payments. Within [***] days following the end of each calendar quarter following the First Commercial Sale of a Product upon which Product Royalties are payable anywhere in the Territory, Artiva shall provide GCLC with a report containing the following information for the applicable calendar quarter, on a Product-by-Product and country-by-country basis: (i) Net Sales of such Product in such country; (ii) the basis for any adjustments to royalties due to GCLC on account of Net Sales of such Product in such country; (iii) a calculation of the royalty payment due to GCLC on account of Net Sales of such Product in such country; and (iv) the exchange rate used in calculating any of the foregoing; provided that the obligations under this Section 3.2(c) may be satisfied by the report due by Artiva to GCLC under Section 6.1(c) of the Option Agreement. Concurrent with the delivery of the applicable quarterly report, Artiva shall pay the royalty payment due to GCLC pursuant to this Section 3.2 for such calendar quarter.
(d) Existing Third Party Payment Obligations. GCLC shall be responsible for any payments to any Affiliates or Third Parties for Patents or Information licensed or acquired by GCLC prior to the Effective Date which are included in the Product Technology.
(e) Royalty Adjustments. Product Royalties shall be subject to adjustment as a result of the events set forth below.
(i) No Valid Claim. During any part of the Product Royalty Term for a Product in which there is no Valid Claim of either the GCLC Core Patents or the Product Patents in the country of sale claiming such Product or the manufacture, use or sale of such Product in such country, the Product Royalties shall be reduced by [***], which reduction will be calculated by determining the portion of total Net Sales of the relevant Product in a calendar quarter that is attributable to the country in which such reduction applies, and determining the total Product Royalties for such Product without reduction, and then reducing by [***] the applicable portion (based on Net Sales of such Product in such country as a percentage of total Net Sales of such Product) of total Product Royalties attributable to such Product in such country.
(ii) Third Party Royalty Credit. If Artiva or any of its Affiliates or Sublicensees obtains a license or sublicense from any Third Party under any intellectual property that is necessary in order to manufacture, use, sell, offer for sale or import a Product in the Territory (including any license by a Third Party to Artiva or sublicense by GCLC to Artiva described in Section 5.4(e) of the Option Agreement, but excluding any license or sublicense to Artiva under an Existing Third Party Agreement as provided in Section 5.4(d) of the Option Agreement) (each a Third Party License), and GCLC agrees that such Third Party License is necessary to
manufacture, use, sell, offer for sale or import such Product in the Territory, such agreement not to be unreasonably withheld, then Artiva may deduct [***] of any royalty (or comparable payment based on sales of such Product) payable by Artiva or its Affiliate or Sublicensee in any calendar quarter in consideration for such Third Party License from the Product Royalties that would otherwise be due in any calendar quarter for such Product. Any amount paid to such Third Party which is entitled to be deducted under this Section 3.2(e)(ii) but is not deducted as a result of the limitation set forth in Section 3.2(e)(iv) shall be carried over and applied against Product Royalties payable to GCLC in respect of such Product in such country in subsequent calendar quarters until the full deduction is taken. In no event may Artiva credit payments under a Third Party License to reduce the Product Royalties with respect to a Product under this Section 3.2(e)(ii) and also to reduce the Core IP Royalties payable with respect to the same Product that is a Licensed Product under the Option Agreement.
(iii) Biosimilar Reduction. If a Biosimilar Product to a Product is sold in any country in the Territory during the Product Royalty Term for such Product and country, the Product Royalties payable with respect to such Product in such country will be reduced by [***] for the remainder of such Product Royalty Term.
(iv) Limitation. The total deductions under Sections 3.2(e)(ii) and (iii) shall not reduce the Product Royalties payable to GCLC under Section 3.2 (as reduced under Section 3.2(e)(i), if applicable) with respect to a Product in a given country in any calendar quarter by more than [***]. In no event will the Product Royalties be reduced for any reason whatsoever other than as provided in this Section 3.2(e).
3.3 Milestone Payments.
(a) Development Milestone Payments. Artiva shall make the following non-refundable and non-creditable development milestone payments to GCLC within [***] days after the first achievement of each applicable milestone event with respect to a Product by Artiva or its Affiliates or Sublicensees. Each such milestone payment shall be paid only once during the Term, the first time a Product reaches such milestone event and regardless of the number of times such milestone event is reached for a Product and of the number of subsequent Products reaching such milestone event. For clarification, the total milestone payments payable hereunder if all milestone events are achieved is [***].
(b) Sales Milestone Payments. Artiva shall make the following one-time, non-refundable and non-creditable sales milestone payments to GCLC when the aggregate annual Net Sales of Products in the Territory first reach the thresholds specified below. Artiva shall notify GCLC promptly of the achievement of each such sales threshold. Each sales milestone payment shall be made by Artiva within [***] days after the end of the calendar quarter in which such sales threshold is achieved. To the extent more than one sales threshold is reached in any given calendar year, then the applicable milestone payment for each such achievement shall be due and owing with respect to such calendar year. For clarification, the total milestone payments payable hereunder if all milestone events are achieved is [***].
Territory-wide Net Sales of Products in a calendar year of at least $[***]
Territory-wide Net Sales of Products in a calendar year of at least $[***]
Territory-wide Net Sales of Products in a calendar year of at least $[***]
3.4 Payment Method; Currency. All payments due under this Agreement to GCLC shall be made by bank wire transfer in immediately available funds to an account designated by GCLC. All payments hereunder shall be made in Dollars. When conversion of payments from any currency other than Dollars is required, such conversion shall be at an exchange rate equal to the weighted average of the rates of exchange for the currency of the country from which such payments are payable as published by The Wall Street Journal, Western U.S. Edition, during the calendar quarter in which the applicable sales were made.
3.5 Records; Inspection. Artiva shall, and shall cause its Affiliates and Sublicensees to, keep complete, true and accurate books of account and records for the purpose of determining the payments to be made under this Agreement. Such books and records shall be kept for [***] years following the end of the calendar year to which they pertain. Such records shall be open for inspection during such period by independent accountants, solely for the purpose of verifying payment statements hereunder for a period covering not more than [***] months prior to the date of request; provided that no period shall be subject to inspection under this section more than once and inspections with respect to payments on a Product under this Agreement shall be done concurrently with respect to payments on the same Product under the Option Agreement to avoid duplication. Such inspections shall be made no more than once each calendar year, on reasonable notice during normal business hours. The independent accountants will execute a reasonable written confidentiality agreement with Artiva and will disclose to GCLC only such information as is reasonably necessary to provide GCLC with information regarding any actual or potential discrepancies between amounts reported and actually paid and amounts payable under this Agreement. The auditor will send a copy of the report to Artiva at the same time it is sent to GCLC. The report sent to both Parties will include the methodology and calculations used to determine the results. Any unpaid amounts that are discovered shall be paid promptly by Artiva. Inspections conducted under this Section 3.5 shall be at the expense of GCLC, unless the inspection discloses an underpayment by Artiva of [***] or more of the amount due for any period covered by the inspection, whereupon all costs relating to the inspection for such period shall be paid promptly by Artiva. If the inspection discloses an overpayment by Artiva, then Artiva will deduct the amount of such overpayment from amounts otherwise owed to GCLC under this Agreement, unless no further payments are due hereunder, in which case the amount of such overpayment shall be refunded by GCLC to Artiva.
3.6 Income Tax Withholding. Except as otherwise provided herein, GCLC will pay any and all taxes levied on account of any payments made to it under this Agreement. GCLC shall be responsible for any transfer, documentary, sales use, stamp, registration, value added or other similar tax (Transfer Tax) that is imposed with respect to the payments or the related transfer of rights or other property pursuant to the terms of this Agreement. If any taxes are required to be withheld by Artiva from any payment made to GCLC under this Agreement (Withholding Taxes), Artiva shall (a) deduct such Withholding Taxes from the payment made to GCLC, (b) timely pay the Withholding Taxes to the proper taxing authority, and (c) send proof of payment to GCLC and certify its receipt by the taxing authority within [***] days following such payment and all such Withholding Taxes shall be treated for all purposes under this Agreement as having been paid to GCLC. To extent Artiva fails to withhold Withholding Taxes from, or apply and pay Transfer Taxes with respect to, any payment to GCLC and it is determined that Artiva should have withheld Withholding Taxes or applied and paid Transfer Taxes, GCLC agrees to indemnify and/or reimburse Artiva for any Withholding Taxes or Transfer Taxes, along with penalties and interest as applicable.
3.7 Tax Documentation. GCLC has provided a properly completed and duly executed IRS Form W-8BEN-E to Artiva. Prior to the receipt of any payment under this Agreement, GCLC (and any other recipient of payments by Artiva under this Agreement) shall, to the extent it is legally permitted to, provide to Artiva, at the time or times reasonably requested by Artiva or as required by applicable Law, such properly completed and duly executed IRS Forms W-8 or W-9 claiming the benefits of an applicable tax treaty in the case of IRS Form W-8BEN-E. Such tax forms will, if applicable and legally permissible, claim the benefits of an applicable tax treaty to permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes.
4. INTELLECTUAL PROPERTY
4.1 Ownership. All Information, discoveries and inventions (patentable or not) generated, conceived or reduced to practice in the performance of the research, development, commercialization or other activities contemplated by this Agreement, including all intellectual property rights therein, shall be as follows: (a) Artiva shall own all Information, discoveries and inventions made solely by employees, agents or independent contractors of Artiva and all intellectual property rights therein, (b) GCLC shall own all Information, discoveries and inventions made solely by employees, agents or independent contractors of GCLC and all intellectual property rights therein, and (c) the Parties shall jointly own all Information, discoveries and inventions made jointly by employees, agents or independent contractors of each Party (Additional Joint Inventions) and all intellectual property rights therein. All Patents claiming Joint Inventions shall be referred to herein as Additional Joint Patents. Subject to the rights and licenses granted under this Agreement, any other Selected Product License Agreement and the Option Agreement, each Party shall be entitled to practice, grant licenses to, assign and exploit the Additional Joint Inventions and Additional Joint Patents without the duty of accounting or seeking consent from the other Party within the Partys respective territory.
4.2 Patent Prosecution.
(a) Product Patents. Artiva shall have the first right, but not the obligation, at Artivas expense, to control the preparation, filing, prosecution (including any interferences, re-issue proceedings and re-examinations) and maintenance of the Product Patents in the Territory. Artiva shall keep GCLC reasonably informed of progress with regard to the preparation, filing, prosecution and maintenance of Product Patents in the Territory, including the countries in the Territory in which it intends to file, maintain or abandon a given Product Patent. Artiva will notify GCLC of all warning letters, conflict proceedings, re-examinations, re-issuance, oppositions, revocation proceedings or any other material challenge relating to a given Product Patent in the Territory. Artiva will consult with, and consider in good faith the requests and suggestions of, GCLC with respect to strategies for filing and prosecuting such Product Patents in the Territory. In the event that Artiva desires to abandon or cease prosecution or maintenance of any Product Patent in the Territory, Artiva shall provide reasonable prior written notice to GCLC of such intention (which notice shall, in any event, be given no later than [***] days prior to the next deadline for any action that may be taken with respect to such Product Patent in the Territory with
the applicable patent office), and upon GCLCs written election provided no later than [***] days after such notice from Artiva, Artiva shall continue prosecution or maintenance of such Product Patent at GCLCs direction and expense. If GCLC does not provide such election within [***] days after such notice from Artiva, Artiva may continue prosecution and maintenance of such Product Patent in the Territory or discontinue prosecution and maintenance of such Product Patent in the Territory. GCLC shall have the sole right, but not the obligation, at GCLCs expense, to control the preparation, filing, prosecution (including any interferences, reissue proceedings and reexaminations) and maintenance of the Product Patents outside the Territory. GCLC shall keep Artiva reasonably informed of progress with regard to the preparation, filing, prosecution and maintenance of Product Patents outside the Territory to the extent such activities could affect the Product Patents in the Territory.
(b) Additional Joint Patents. Additional Joint Patents shall be governed by Section 4.2(a).
(c) Cooperation. Promptly following the Effective Date, (but no less than [***] days before any statutory bar date), GCLC will transfer to Artiva all Information concerning the Product Patents in the Territory. GCLC shall cooperate with Artiva and shall execute any power of attorney or similar document, in each case to the extent reasonably required to allow Artiva to assume the preparation, filing, prosecution and maintenance in the Territory of the Product Patents in Artivas name. Artiva shall cooperate with GCLC, in each case to the extent reasonably required to allow GCLC to assume the preparation, filing, prosecution and maintenance, of any Patent abandoned by Artiva pursuant to Section 4.2(a).
4.3 Patent Enforcement.
(a) Notification. If either Party becomes aware of any existing or threatened infringement of the Product Patents, Additional Joint Patents or Product Technology related to any Existing Third Party Agreements, or the filing of a BLA by a Third Party for a product that names a Product as a reference product (or similar filing in a country other than the U.S.), it shall promptly notify the other Party in writing to that effect, and the Parties will consult with each other regarding any actions to be taken with respect to such infringement.
(b) Right to Enforce. Artiva shall have the first right, but shall not be obligated, to bring and control an infringement action with respect to any Product Patent or Additional Joint Patent in the Territory against any person or entity, at Artivas sole cost and expense. If Artiva does not bring such an action with respect to a Product Patent or Additional Joint Patent in the Territory (or settle or otherwise secure the abatement of such infringement) prior to the earlier of: (i) [***] days following Artivas receipt or delivery of the notice under Section 4.3(a), or (ii) [***] days before the deadline, if any, set forth in the applicable Laws for the filing of such actions, GCLC shall have the right to bring and control any such action, at its own expense and by counsel of its own choice.
(c) Cooperation. Each Party shall cooperate fully with the enforcing Party in such enforcement, at such enforcing Partys request and expense, including joining such action as a party plaintiff if required by applicable Laws to pursue such action. The enforcing Party shall keep the other Party regularly informed of the status and progress of such enforcement efforts, shall reasonably consider the other Partys comments on any such efforts. The non-enforcing Party shall be entitled to separate representation in such matter by counsel of its own choice and at its own expense, but such Party shall at all times cooperate fully with the enforcing Party. Neither Party shall have the right to settle any patent infringement litigation under this Section 4.3 in a manner that diminishes the rights or interests of the other Party without the prior written consent of such other Party, such consent not to be unreasonably withheld or delayed.
(d) Expenses and Recoveries. The enforcing Party bringing a claim, suit or action under this Section 4.3 shall be solely responsible for any expenses incurred by such Party as a result of such claim, suit or action. If such Party recovers monetary damages in such claim, suit or action, except as otherwise agreed by the Parties in connection with a cost-sharing arrangement, such recovery shall be allocated first to the reimbursement of any expenses incurred by the Parties in such litigation, and any remaining amounts shall be shared as follows: [***].
(e) Enforcement Outside the Territory. GCLC shall have the sole right, but shall not be obligated, to bring and control an infringement action with respect to any Product Patent or Additional Joint Patent outside the Territory against any person or entity, at GCLCs sole cost and expense. GCLC shall keep Artiva reasonably informed of the enforcement of Product Patents or Additional Joint Patents outside the Territory to the extent such activities could affect the Product Patents or Additional Joint Patents in the Territory.
4.4 Patent Oppositions and Other Proceedings.
(a) In the Territory. If a Product Patent or Additional Joint Patent in the Territory becomes the subject of any proceeding commenced by a Third Party in connection with an opposition, action for declaratory judgment, nullity action, interference or other attack upon the validity, title or enforceability thereof, then Artiva shall have the first right, but not the obligation, to control such defense at its own expense using counsel of its own choice. If Artiva decides that it does not wish to defend against such action, it shall notify GCLC reasonably in advance of all applicable deadlines, and GCLC shall thereafter have the right, but not the obligation, to assume defense of such action at its own expense.
(b) The Party controlling any defense under Section 4.4(a) shall permit the non-controlling Party to participate in the proceedings to the extent permissible under applicable Laws and to be represented by its own counsel at the non-controlling Partys expense. Notwithstanding any of the foregoing, the Party controlling any enforcement action pursuant to Section 4.3 shall also have the sole right to control the response to any attack on the validity, title, or enforceability of a Patent that is asserted by the alleged infringer(s) as a counterclaim or affirmative defense in such action. Neither Party shall have the right to settle any proceeding under this Section 4.4 in a manner that diminishes the rights or interests of the other Party without the prior written consent of such other Party, such consent not to be unreasonably withheld or delayed.
(c) Outside the Territory. GCLC shall have the sole right, but shall not be obligated, to control any opposition, action for declaratory judgment, nullity action, interference or other attack upon the validity, title or enforceability of any Product Patent or Additional Joint Patent outside the Territory, at GCLCs own expense using counsel of its own choice. GCLC shall keep Artiva reasonably informed of any such defense of Product Patents or Additional Joint Patents outside the Territory to the extent such activities could affect the Product Patents or Additional Joint Patents in the Territory.
4.5 Patent Marking. Artiva shall mark Product (or when the character of the product precludes marking, the package containing any such Product) marketed and sold by Artiva or its Affiliates or Sublicensees in accordance with all applicable Laws relating to patent marking.
4.6 Infringement of Third Party Rights. If any Product used or sold by Artiva or its Affiliates or Sublicensees becomes the subject of a Third Partys claim or assertion of infringement of a Patent, each Party shall promptly notify the other Party. Neither Party shall have the right to settle any patent infringement litigation under this Section 4.6 in a manner that diminishes the rights or interests of the other Party without the written consent of such other Party (which shall not be unreasonably withheld).
5. TERM AND TERMINATION
5.1 Term. This Agreement shall become effective on the Effective Date and, unless earlier terminated pursuant to this Article 5, shall remain in effect until the expiration of the last Product Royalty Term in the Territory (the Term).
5.2 Termination for Material Breach. Each Party shall have the right to terminate this Agreement in its entirety immediately upon written notice to the other Party if the other Party materially breaches its obligations under this Agreement and, after receiving written notice identifying such material breach in reasonable detail, fails to cure such material breach within sixty (60) days from the date of such notice (or within thirty (30) days from the date of such notice in the event such material breach is solely based on the breaching Partys failure to pay any amounts due hereunder); provided, however, in the case of a breach or violation that cannot be cured within such sixty (60) day period, the non-breaching Party may terminate this Agreement following such sixty (60) day period only if the breaching Party shall have failed to commence substantial remedial actions within such sixty (60) day period and to use reasonable efforts to pursue the same. Any right to terminate under this Section 5.2 shall be stayed and the cure period tolled in the event that, during any cure period, the breaching Party shall have initiated dispute resolution in accordance with Article 13 of the Option Agreement with respect to the alleged breach, which stay and tolling shall last so long as the breaching Party diligently and in good faith cooperates in the prompt resolution of such dispute resolution proceedings. Each Party shall be entitled to offset, against amounts payable to the other Party under this Agreement, any amounts of damages determined, in a final decision by the applicable court action or other legal proceeding, to be owed to such Party by the other Party based on the other Partys material breach of this Agreement.
5.3 Termination Upon Insolvency. Either Party may terminate this Agreement upon written notice to the other Party, if, at any time, the other Party (a) files in any court or agency pursuant to any statute or regulation of any state, country or jurisdiction, a petition in bankruptcy or insolvency or for reorganization or for an arrangement or for the appointment of a receiver or trustee of such other Party or of its assets, (b) is served with an involuntary petition against it, filed in any insolvency proceeding that is not dismissed within ninety (90) days after the filing thereof, or (c) makes an assignment of the assets associated with this Agreement for the benefit of its creditors.
5.4 Termination by Artiva. Artiva may terminate this Agreement in its entirety without cause upon ninety (90) days prior written notice to GCLC.
5.5 Effects of Expiration or Termination of this Agreement. Upon any expiration or termination of this Agreement, all rights and obligations of the Parties shall terminate entirely, except as provided in this Section 5.5 and Section 5.7 and the sections referenced therein and:
(a) Termination of License to Artiva. All rights and licenses granted to Artiva hereunder shall terminate, except for any and all licenses that survive expiration or termination in accordance with the last sentence of Section 3.2(b); provided that if this Agreement is terminated by GCLC pursuant to Section 5.2 or 5.3, any sublicense granted to a Sublicensee that is not in breach under the applicable sublicense (and whose actions or omissions did not result in a breach by Artiva giving rise to GCLCs right of termination) will continue as a direct license from GCLC so long as the Sublicensee makes all payments to GCLC required under Section 3.2 and Section 3.3.
(b) Remaining Inventories. Artiva or its Affiliates, to the extent that such parties continue to have stocks of usable Products that would be subject to payment of Product Royalties pursuant to Section 3.2, may continue to fulfill orders received for Products until [***] months following the date of termination. For Products sold by Artiva or its Affiliates after the effective date of a termination, Artiva shall continue to pay Product Royalties pursuant to Section 3.2, as applicable.
(c) Additional Effects of Termination. Upon any termination of this Agreement, except termination of this Agreement by Artiva under Section 5.2, effective as of such termination, Artiva shall promptly (A) assign and transfer (or cause to be assigned and transferred) to GCLC or its designee (and provide copies of) all Regulatory Materials and Regulatory Approvals held in the name of Artiva, or any Affiliate it controls (within the meaning of Section 1.1 of the Option Agreement), relating to any Product, including related correspondence with Regulatory Authorities and (B) disclose to GCLC, and grant to GCLC a Right of Reference and Use (as that term is defined in 21 C.F.R. § 314.3(b) or any non-United States equivalent) with respect to, all pre-clinical and clinical data, including pharmacology and biology data, in Artivas or its applicable controlled Affiliates Control with respect to any Product.
5.6 Damages; Relief. Termination of this Agreement shall not preclude either Party from claiming any other damages, compensation or relief that it may be entitled to upon such termination.
5.7 Survival. Termination or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior to the date of termination or expiration (including any rights or obligations with respect to payments due and owing prior to the date of termination or expiration). Notwithstanding anything to the contrary, the following provisions shall survive any expiration or termination of this Agreement: Articles 1 and 8 and Sections 2.5, 3.2(b) (final sentence only), 3.5 (for the term stated therein), 4.1, 5.5, 5.6, 5.7, 5.8, 6.5, 7.1, 7.2 and 7.3 (for [***] years), as well as Article 1 (Definitions) to the extent necessary to give meaning to terms defined therein, Articles 9 and 13 and Sections 14.2 through Section 14.11 of the Option Agreement as applied to this Agreement pursuant to Section 8.2.
5.8 Rights under Bankruptcy or Insolvency Laws. All rights and licenses granted under or pursuant to this Agreement by one Party to the other Party are, and will otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws, licenses of right to intellectual property as defined under Section 101 of the U.S. Bankruptcy Code or comparable provision of applicable bankruptcy or insolvency laws. The Parties agree that a Party that is a licensee of such rights under this Agreement will retain and may fully exercise all of its rights and elections under the provisions of applicable bankruptcy or insolvency laws. The Parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against a Party to this Agreement under the provisions of applicable bankruptcy or insolvency laws, the other Party will be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, and same, if not already in its possession, will be promptly delivered to it (a) upon any such commencement of a bankruptcy or insolvency proceeding upon its written request therefor, unless the bankrupt Party elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered pursuant to clause (a) above, following the rejection of this Agreement by or on behalf of the bankrupt Party upon written request therefor by the other Party.
6. REPRESENTATIONS AND WARRANTIES AND COVENANTS
6.1 Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows:
(a) Corporate Existence. As of the Effective Date, it is a company or corporation duly organized, validly existing, and in good standing under the Laws of the jurisdiction in which it is incorporated.
(b) Corporate Power, Authority and Binding Agreement. As of the Effective Date, (i) it has the corporate power and authority and the legal right to enter into this Agreement and perform its obligations hereunder; (ii) it has taken all necessary corporate action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder; and (iii) this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.
(c) No Conflicts. The execution and delivery of this Agreement, and the performance by such Party of its obligations under this Agreement, including the grant of rights and licenses to the other Party pursuant to this Agreement, does not and will not: (i) conflict with, nor result in any violation of or default under, any instrument, judgment, order, writ, decree, contract or provision to which such Party is bound; (ii) give rise to the suspension, revocation, impairment, forfeiture or non-renewal of any material permit, license, authorization or approval that applies to such Party, its business or operations or any of its assets or properties; or (iii) conflict with any rights granted by such Party to any Third Party or breach any obligation that such Party has to any Third Party.
6.2 GCLC Representations and Warranties. GCLC represents and warrants to Artiva as of the Effective Date that:
(a) GCLC is the sole and exclusive owner of the Patents set forth on Exhibit 1.14, in each case free and clear of all liens, and GCLC has the right to grant the licenses, sublicenses and other rights with respect to the Product Patents that it purports to grant hereunder. Exhibit 1.14 is a true and complete list of all Patents Controlled by GCLC or any GCLC Subsidiary as of the Effective Date that relate specifically to a Product or its manufacture or use (other than any GCLC Core Patents). All official fees, maintenance fees and annuities for the Product Patents have been paid through the Effective Date.
(b) All issued Product Patents are in full force and effect and subsisting, and inventorship of each Patent is properly identified on such Patents. No Third Party has asserted in writing that any issued Product Patent is invalid or unenforceable. None of the Product Patents is currently involved in any interference, reissue, reexamination, or opposition proceeding, and no such proceeding is threatened to the Knowledge of GCLC. GCLC has taken reasonable security measures consistent with industry standard practices, including measures against unauthorized disclosure, to protect the secrecy and confidentiality of trade secrets within the Product Know-How. GCLC and GCLC Subsidiaries have complied with all duties of candor required by applicable Governmental Authorities in the prosecution by GCLC or any GCLC Subsidiaries of any rights in the Product Technology.
(c) GCLC (i) has provided Artiva a true and complete copy of the Existing Third Party Agreements, including any amendments thereto, and the Existing Third Party Agreements are in full force and effect in accordance with its terms; and (ii) is in compliance in all material respects with its obligations under the Existing Third Party Agreements and, to GCLCs knowledge, (A) the other parties to the Existing Third Party Agreements have not breached the Existing Third Party Agreements in any material respect, and (B) there is no basis for termination of the Existing Third Party Agreements;
(d) To GCLCs Knowledge, there are no activities by Third Parties that would constitute an infringement of the Product Patents or misappropriation of the Product Know-How.
(e) Neither GCLC nor any GCLC Subsidiary has received any written notice from any person, or have Knowledge of, any actual or threatened claim or assertion that the use or practice of the Product Technology infringes or misappropriates the intellectual property rights of a Third Party.
(f) There are no actual, pending, or alleged or threatened in writing, adverse actions, suits, claims, interferences or formal governmental investigations by or against GCLC or any GCLC Subsidiary in or before any court or Governmental Authority involving Product Technology.
(g) GCLC and GCLC Subsidiaries have complied in all material respects with all applicable Laws, including all good clinical practices, good laboratory practices and good manufacturing practices, permits, governmental licenses, registrations, approvals, authorizations, orders, injunctions and decrees, in the research, development, manufacture and use of any Product, and neither GCLC nor any GCLC Subsidiary has received any written notice from any Governmental Authority claiming that any such activities as conducted by it are not in such compliance.
(h) All of GCLCs and GCLC Subsidiaries employees acting on its behalf who have performed research, development, manufacturing or regulatory activities with respect to any Product are and will be obligated under a binding written agreement to comply with obligations of confidentiality and non-use no less restrictive than those set forth in Article 9 of the Option Agreement.
6.3 Covenants. Each Party covenants to the other Party as follows:
(a) No Debarment. Neither such Party, nor, in the case of GCLC, its GCLC Subsidiaries, is debarred or disqualified under the United States Federal Food, Drug and Cosmetic Act or comparable applicable Laws in the Territory and, in the course of development, manufacturing or other activities relating to any Product, neither Party, nor, in the case of GCLC, its GCLC Subsidiaries, has used or shall use any employee, consultant or subcontractor who has been debarred or disqualified or, to such Partys Knowledge, is the subject of debarment or disqualification proceedings by a Regulatory Authority. Each Party shall notify the other Party promptly upon becoming aware that any of its or its subsidiaries employees, consultants or subcontractors involved in any development, manufacturing or other activities relating to any Product has been debarred or disqualified or is the subject of debarment or disqualification proceedings by any Regulatory Authority.
(b) Compliance. Both Parties and their respective Affiliates shall comply in all material respects with all applicable Laws in the development, manufacture and commercialization of any Product, in each case, to the extent applicable, including the statutes, regulations and written directives of the FDA, the EMA and any other Regulatory Authorities, the Federal Food, Drug & Cosmetic Act, as amended, the Prescription Drug Marketing Act, the Federal Health Care Programs Anti-Kickback Law, 42 U.S.C. 1320a-7b(b), the statutes, regulations and written directives of Medicare, Medicaid and all other health care programs, as defined in 42 U.S.C. § 1320a-7b(f), and the Foreign Corrupt Practices Act of 1977, each as may be amended from time to time.
(c) Employees and Subcontractors. During the Term, all employees and subcontractors of a Party or its Affiliates performing research, development, commercialization or other activities contemplated hereunder on behalf of such Party or its Affiliates shall be obligated to undertake in writing obligations of ownership of Information, discoveries and inventions which are the same as those undertaken by the Parties pursuant to Section 4.1.
6.4 Additional GCLC Covenant. GCLC hereby covenants to Artiva that during the Term, GCLC shall not amend, modify or terminate any of the Existing Third Party Agreements in a manner that could affect Artiva, except with Artivas prior written consent.
6.5 Disclaimer. EXCEPT AS EXPRESSLY STATED IN THIS AGREEMENT, NO REPRESENTATIONS OR WARRANTIES WHATSOEVER, WHETHER EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, OR NON-MISAPPROPRIATION OF THIRD PARTY INTELLECTUAL PROPERTY RIGHTS, ARE MADE OR GIVEN BY OR ON BEHALF OF A PARTY, AND ALL REPRESENTATIONS AND WARRANTIES, WHETHER ARISING BY OPERATION OF LAW OR OTHERWISE, ARE HEREBY EXPRESSLY EXCLUDED.
7. INDEMNIFICATION AND LIMITATION OF LIABILITY
(a) Indemnification by Artiva. Artiva shall defend, indemnify, and hold GCLC and its Affiliates and their respective officers, directors, employees, and agents (the GCLC Indemnitees) harmless from and against any and all damages or other amounts payable by such GCLC Indemnitees, including any reasonable attorneys fees, taxes (including penalties and interest), and costs of litigation incurred by, such GCLC Indemnitees, to the extent resulting from claims, suits, proceedings, or causes of action brought by any Third Party (Claims) against such GCLC Indemnitees that arise from or are based on: (i) the development, manufacture or commercialization of any Product in the Territory, or performance of the CMC Activities, by or on behalf of Artiva or its Affiliates or Sublicensees (excluding in all cases GCLC or its Affiliates); (ii) the breach of any of Artivas obligations under this Agreement, including Artivas representations, warranties or covenants set forth herein; (iii) the use or application of a Third Party License in the development, manufacture, commercialization or other disposal of any Product in the Territory; or (iv) the willful misconduct or negligent acts of Artiva or any of its Affiliates or any of its or their respective officers, directors, employees or agents. The foregoing indemnity obligation shall not apply to the extent to the extent that any of the Claims arises from, is based on, or results from any activity described in Section 7.1(b)(i), (ii) or (iii) for which GCLC is obligated to indemnify the Artiva Indemnitees under Section 7.1(b).
(b) Indemnification by GCLC. GCLC shall defend, indemnify, and hold Artiva and its Affiliates and their respective officers, directors, employees, and agents (the Artiva Indemnitees) harmless from and against any and all damages or other amounts payable by such GCLC Indemnitees, including any reasonable attorneys fees, taxes (including penalties and interest), and costs of litigation incurred by such Artiva Indemnitees, to the extent resulting from Claims against such Artiva Indemnitees that arise from or are based on: (i) activities of, or on behalf of GCLC or GCLC Subsidiaries, licensee or sublicensees (other than Artiva and its Affiliates and Sublicensees) for the development, manufacture or commercialization of any Product, that give rise to a Third Party claim against an Artiva Indemnitee; (ii) the breach of any of GCLCs obligations under this Agreement, including of GCLCs representations, warranties or covenants set forth herein; or (iii) the willful misconduct or negligent acts of GCLC or any of GCLC Subsidiaries or any of its or their respective officers, directors, employees or agents. The foregoing indemnity obligation shall not apply to the extent to the extent that any of the Claims arises from, is based on, or results from any activity set forth in Section 7.1(a)(i), (ii) or (iii) for which Artiva is obligated to indemnify the GCLC Indemnitees under Section 7.1(a).
(c) Indemnification Procedures. The Party seeking indemnification (individually, the Indemnified Party), shall promptly notify the other Party (the Indemnifying Party) in writing of the Claim. Such Claim for indemnity shall indicate the nature of the Claim and the basis therefor. Promptly after a Claim is made for which the Indemnified Party seeks indemnity, the Indemnified Party shall permit the Indemnifying Party, at its option and expense, to assume the complete defense of such Claim, provided that (i) the Indemnified Party will have the right to participate in the defense of any such Claim at its own cost and expense, (ii) the Indemnifying Party will conduct the defense of any such Claim with due regard for the business interests and potential related liabilities of the Indemnified Party, and (iii) the Indemnifying Party will not agree to any settlement that would admit liability on the part of the Indemnified Party or involve relief other than payment of money, without the approval of the Indemnified Party, not to be unreasonably withheld; and provided, further, that if it is reasonably likely that the Parties may have conflicting interests or if it is otherwise not advisable under applicable legal and ethical requirements for the Indemnifying Partys defense counsel to represent both Parties, separate independent counsel shall be retained for each Party at its own expense. The Indemnifying Party will not, in defense of any such Claim, except with the consent of the Indemnified Party, consent to the entry of any judgment or enter into any settlement which does not include, as an unconditional term thereof, the giving by the claimant or plaintiff to the Indemnified Party of a release from all liability in respect thereof. After notice to the Indemnified Party of the Indemnifying Partys election to assume the defense of such Claim, the Indemnifying Party shall be liable to the Indemnified Party for such legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof at the request of the Indemnifying Party. As to those Claims with respect to which the Indemnifying Party does not elect to assume control of the defense, the Indemnified Party will afford the Indemnifying Party an opportunity to participate in such defense at the Indemnifying Partys own cost and expense, and will not settle or otherwise dispose of any of the same without the consent of the Indemnifying Party.
7.2 Limitation of Liability. NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE, OR INDIRECT DAMAGES ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE POSSIBILITY OF SUCH DAMAGES. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 7.2 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTION 7.1 OR DAMAGES AVAILABLE FOR A PARTYS BREACH OF CONFIDENTIALITY OBLIGATIONS IN ARTICLE 9 OF THE OPTION AGREEMENT AS APPLIED TO THIS AGREEMENT.
7.3 Insurance. Each Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder and which is consistent with normal business practices of prudent companies similarly situated at all times during which any Product is being clinically tested in human subjects or commercially distributed or sold. Each Party shall provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least [***] days prior to the cancellation, non-renewal or material changes in such insurance. It is understood that such insurance shall not be construed to create a limit of either Partys liability with respect to its indemnification obligations under this Article 7.
8.1 Entire Agreement; Amendments. This Agreement, including the Exhibits hereto, any other Selected Product License Agreements and the Option Agreement, sets forth the complete, final and exclusive agreement and all the covenants, promises, agreements, warranties, representations, conditions and understandings between the Parties hereto with respect to the subject matter hereof, and supersedes all prior agreements and understandings between the Parties with respect to the subject matter hereof. There are no covenants, promises, agreements, warranties, representations, conditions or understandings, either oral or written, between the Parties other than as are set forth in this Agreement. No subsequent alteration, amendment, change or addition to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an authorized officer of each Party.
8.2 Inclusion of Certain Terms of the Option Agreement. Save for the extent of modification or amendment effected by this Agreement, the following terms of the Option Agreement are incorporated herein mutatis mutandis with respect to this Agreement and will continue to apply to this Agreement even if the Option Agreement expires or terminates: Article 1 (Definitions) to the extent necessary to give meaning to terms defined therein, Article 7 (Development), Article 9 (Confidentiality), Article 13 (Dispute Resolution) (except for Section 13.5), Section 14.2 (Force Majeure), Section 14.3 (Notices), Section 14.4 (Assignment), Section 14.5 (Performance by Affiliates), Section 14.6 (Further Actions), Section 14.7 (Severability), Section 14.8 (No Waiver), Section 14.9 (Independent Contractors), Section 14.10 (Governing Law) and Section 14.11 (Construction of this Agreement).
8.3 Counterparts. This Agreement may be executed in two (2) or more counterparts, each of which shall be an original and all of which shall constitute together the same document. Counterparts may be signed and delivered by facsimile, or electronically in PDF format, each of which shall be binding when sent.
[Signature page follows.]
IN WITNESS WHEREOF, the Parties have executed this Agreement in duplicate originals by their proper officers as of the Effective Date.
|ARTIVA BIOTHERAPEUTICS, INC.||GREEN CROSS LABCELL CORPORATION|
|Title:||CEO||Title:||Chief Executive Officer|
(Date of filing)