Secondary Products Approved for Cardiovascular Indication Sample Clauses

Secondary Products Approved for Cardiovascular Indication. Within thirty (30) days following the first occurrence of each of the events set forth below with respect to each Secondary Product developed for a Cardiovascular Indication, regardless of whether such Secondary Product has previously received Regulatory Approval for an indication other than a Cardiovascular Indication, Amylin shall pay to Restoragen the applicable milestone payment set forth below: Milestone Event Milestone Payment Filing of NDA in the U.S. for a Secondary Product for a Cardiovascular Indication $ 1,000,000 Regulatory Approval for an Secondary Product in the U.S. for a Cardiovascular Indication $ 4,000,000 Regulatory Approval by the European Commission to sell an Secondary Product in all European Union countries for a Cardiovascular Indication $ 2,000,000 Regulatory Approval for an Secondary Product in Japan for a Cardiovascular Indication $ 1,000,000 Each of the milestone payments described in this Section 9.1(b) shall be payable on a Secondary Product-by-Secondary Product basis; provided, however, that if (i) a Secondary Product is abandoned during development after one (1) or more of the milestone payments under this Section 9.1(b) has been made and (ii) another Secondary Product is developed to replace such abandoned Secondary Product, then only those milestone payments under this Section 9.1(b) that were not previously made with respect to such abandoned Secondary Product shall be payable with respect to the replacement Secondary Product. Except as set forth in the preceding sentence, all milestone payments are non-refundable and non-creditable.
Sample 1
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Secondary Products Approved for Cardiovascular Indication. But First Approved for Non-Cardiovascular Indication. Within thirty (30) days following the first occurrence of each of the events set forth below with respect to each Secondary Product that receives Regulatory Approval in the U.S. for a Cardiovascular Indication, which Secondary Product at the time of such Regulatory Approval had previously received Regulatory Approval in the U.S. for an indication other than a Cardiovascular Indication, Amylin shall pay to Restoragen the applicable milestone payment set forth below: Milestone Event Milestone Payment First Commercial Sale of such Secondary Product in the U.S. $ 1,000,000 Cumulative Net Sales of such Secondary Product of $250,000,000 $ 1,000,000 Cumulative Net Sales of such Secondary Product of $500,000,000 $ 1,000,000 Cumulative Net Sales of such Secondary Product of $1,000,000,000 $ 1,000,000 Each of the milestone payments described in this Section 9.1(c) shall be payable once per Secondary Product meeting the criteria set forth above in this Section 9.1(c). For purposes of clarification, the foregoing milestones shall be in addition to the milestones payable under Section 9.1(b), but no royalties shall be due under Section 9.2 of this Agreement with respect to Secondary Products meeting the criteria set forth in the first sentence of this Section 9.1(c). All such milestone payments are non-refundable and non-creditable.
Sample 1

Related to Secondary Products Approved for Cardiovascular Indication

  • 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.

  • 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.

  • New Products You agree to comply with NASD Notice to Members 5-26 recommending best practices for reviewing new products.

  • 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.

  • 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.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

  • Product The term “

  • Licensed Territory Worldwide NIH Patent License Agreement—Exclusive APPENDIX C – ROYALTIES Royalties:

  • Commercialization Plans As soon as practicable after formation of the JCC (following Acucela’s exercise of an Opt-In Right under Section 3.1), the JCC shall prepare and approve the initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation (and, if applicable, any New Formulation or Other Indication Product) in the Territory. The Parties shall use Commercially Reasonable Efforts to ensure that such initial Commercialization Plan for Commercialization of the Licensed Product for the Initial Indication in the Initial Formulation is consistent with the general Commercialization Plan outline set forth in Exhibit C attached hereto and incorporated herein (the “General Commercialization Plan Outline”). The JCC shall prepare and approve a separate Commercialization Plan for Commercialization of Licensed Product for the Initial Indication in the Initial Formulation in the Territory and for Commercialization of each Other Indication Product and New Formulation (if any) in the Territory, and shall update and amend each Commercialization Plan not less than annually or more frequently as needed to take into account changed circumstances or completion, commencement or cessation of Commercialization activities not contemplated by the then-current Commercialization Plan. Amendments and revisions to the Commercialization Plan shall be reviewed and discussed, in advance, by the JCC, and Otsuka agrees to consider proposals and suggestions made by Acucela regarding amendments and revisions to the Commercialization Plan. Any amendment or revision to the Commercialization Plan that provides for an increase or decrease in the number of FTEs for any Phase 3b Clinical Trials or Post-Approval Studies as compared to the previous version of the Commercialization Plan, or that provides for addition or discontinuation of tasks or activities as compared to the previous version of the Commercialization Plan, or that moves forward the timetable for activities reflected in the Commercialization Plan, shall provide for a reasonable ramp-up or wind-down period, as applicable, to accommodate a smooth and orderly transition of Commercialization activities to the amended or revised Commercialization Plan. Each Commercialization Plan shall identify the goals of Commercialization contemplated thereunder and shall address Commercialization (including Co-Promotion) activities related to the Licensed Product (including, if applicable, any Other Indication Product), including:

  • Combination Product The term “

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