Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.
Combination Product The term “
Licensed Product “Licensed Product” shall mean any article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights. For clarity, a “Licensed Product” shall not include other product or material that (a) is used in combination with Licensed Product, and (b) does not constitute an article, composition, apparatus, substance, chemical material, method, process or service whose manufacture, use, or sale is covered or claimed by a Valid Claim within the Patent Rights.
Development Milestone Payments In partial consideration for the rights and licenses granted to Coya hereunder, within ten days after the first achievement of each milestone event in a given Indication set forth in this Section 5.2 (Development Milestone Payments) with respect to a Product (each, a “Development Milestone Event”) by or on behalf of Coya or any of its Affiliates or Sublicensees, Coya shall provide ARScience Bio written notice to ARScience Bio identifying the Development Milestone Event achieved. Upon receipt of any such notice of first achievement of a Development Milestone Event by Coya or its Affiliates or Sublicensees, ARScience Bio will promptly invoice Coya for the applicable Development Milestone Event and Coya will make a milestone payment to ARScience Bio in the amount set forth in this Section 5.2 (Development Milestone Payments) corresponding to such Development Milestone Event (each, a “Development Milestone Payment”) within 45 days of receipt of such invoice. On an Indication-by-Indication basis, each Development Milestone Payment shall be payable only upon the first achievement of the corresponding Development Milestone Event by a Product, in any given Indication for which the Development Milestone Events have not been previously achieved (each such Indication, a “New Indication”). No amounts shall be due for subsequent or repeated achievements of such Development Milestone Event with respect to the same or different Mono Product or Combination Product, as applicable, in such Indication. Accordingly and for clarity, the Development Milestone Payment shall be paid only once, when first achieved by Coya, an Affiliate or a Sublicensee, but no payment shall be due if the same milestone is subsequently achieved by one of Coya, an Affiliate or a Sublicensee. For clarity, the amounts owed in Column (a) below shall be due for the first Combination Product to achieve the Development Milestone Events in a New Indication and the amounts owned in Column (c) below shall be due for the first Mono Product to achieve the Development Milestone Events in a New Indication. Any Combination Product or Mono Product to achieve the Development Milestone Events in a New Indication after the first achievement of the Development Milestone Events as described in the foregoing sentence will cause the amounts in Column (b) with respect to a Combination Product and Column (d) with respect to a Mono Product to be due and payable by Coya upon each such occurrence. If the first Product to achieve a Development Milestone Event in any Indication is a Combination Product, the amounts in Column (a) below shall be due and payable by Coya. If the next Product to achieve a Development Milestone Event in a New Indication is a Mono Product, the amounts in Column (c) below would be due and payable by Coya; provided, that if such next Product to achieve a Development Milestone Event in a New Indication is a Combination Product, the amounts in Column (b) would be due and payable by Coya. By way of example, if a Combination Product achieves IND Acceptance in ALS, and is the first Product to achieve a Development Milestone Event under this Agreement, [***] will be due and payable by Coya. If subsequently a Mono Product achieves IND Acceptance in ALS, no Development Milestone Payments will be due and payable by Coya under this Agreement. However, if subsequently any Combination Product achieves IND Acceptance in Alzheimer’s disease, [***] would be due and payable by Coya.
Development Milestones Subject to the terms and conditions of this Agreement, no later than [**] following the first occurrence of each event described below (each, a “Development Milestone”), on Product-by-Product basis Moderna shall pay Carisma the non-refundable and non-creditable amounts set forth below for each Product to achieve such event (each, a “Development Milestone Payment”): Development MilestoneDevelopment Milestone Payment (in US$ millions) [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] [**] Moderna shall provide written notice to Carisma of the achievement of each Development Milestone within [**] after such achievement. If a Development Milestone for a Product is achieved without the preceding Development Milestone(s) having been achieved for such Product, then the Development Milestone Payment for such preceding Development Milestone(s) shall be paid by Moderna to Carisma together with the Development Milestone Payment for the Development Milestone that was achieved. For example, if the [**] Development Milestone [**] in the table above is achieved for a Product but the [**] Development Milestone [**] in the table above had not been achieved for such Product, then Moderna would pay the Development Milestone Payment for both such [**] Development Milestone and [**] Development Milestone upon achievement of the [**] Development Milestone. Each of the Development Milestone Payments set forth above shall be payable one time only per Product. If Moderna or its Affiliates or Sublicensees Develops a Product that has achieved at least one Development Milestone and subsequently discontinues Development of such Product and Develops a different Product incorporating or directed to the same combination of Collaboration Targets (whether one Collaboration Target or multiple Collaboration Targets), then Moderna shall be required to pay Development Milestone Payments for such different Product only for Development Milestones that had not been achieved by such discontinued Product.
Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:
Licensed Products Lessee will obtain no title to Licensed Products which will at all times remain the property of the owner of the Licensed Products. A license from the owner may be required and it is Lessee's responsibility to obtain any required license before the use of the Licensed Products. Lessee agrees to treat the Licensed Products as confidential information of the owner, to observe all copyright restrictions, and not to reproduce or sell the Licensed Products.
Commercialization License Subject to the terms of this Agreement, including without limitation Section 2.2 and Theravance's Co-Promotion rights in Section 5.3.2, Theravance hereby grants to GSK, and GSK accepts, an exclusive license under the Theravance Patents and Theravance Know-How to make, have made, use, sell, offer for sale and import Alliance Products in the Territory.
Milestone Event Milestone Payment [***] [***]
Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and the Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.
