Excluded Indications Sample Clauses

Excluded Indications. Each Proposed Indication that does not become an Accepted Indication pursuant to this Section 3.5 shall be deemed an “Excluded Indication” for purposes of this Agreement.
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Excluded Indications. If the Notice of Approval pertained to the first Regulatory Approval for the applicable Additional Indication for a Licensed Product, then the Adjusted Royalty Rate under Sections 6.5.1(b) for the applicable Collaboration Program shall not apply to Net Sales of such Licensed Product for such Additional Indication (the “Excluded Indication”), and instead the Base Royalty specified in Section 6.5.1(a) shall apply with respect to Net Sales of such Licensed Product for such Excluded Indication (but the Adjusted Royalty Rate shall otherwise continue to apply to Net Sales of such Licensed Product for Indications other than the Excluded Indication). In such event, AbbVie shall use Commercially Reasonable Efforts to distinguish between Net Sales for Excluded Indications and the other Indication. If the Net Sales cannot be distinguished or Licensor disagrees with AbbVie’s methodology for distinguishing, the Parties shall mutually agree on the method of allocating Net Sales of such Licensed Product between the Excluded Indication(s) for such Licensed Product and the other Indications for such Licensed Product, and if the Parties are unable to agree, then upon request by either Party such methodology shall be determined pursuant to Section 13.7.4 below. If thereafter a Party believes the method of allocating Net Sales no longer reflects an accurate estimate of the Net Sales of such Licensed Product for the Excluded Indication, it may request (no more than once in any [***] period), that the methodology be adjusted, and if the Parties are unable to agree on an adjustment, the same shall similarly be determined in accordance with Section 13.7.4. In any case, if the methodology so determined requires that a Third Party (such as IMS or similar data provider) be engaged to estimate sales of the Licensed Product for the Excluded Indications, then AbbVie will initially bear the costs of obtaining such Third Party estimate, and shall be entitled to deduct from the Incremental Royalty due on Net Sales of such Licensed Product for such Excluded Indication [***] of the Out-of-Pocket Costs paid to such Third Party for such estimate. For clarity, in the case of Second Generation Products, this Section 6.5.2(b)(iii)(B) shall apply only if Regulatory Approval is obtained for an Additional Indication subsequent to the first Regulatory Approval of such Second Generation Product.
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Excluded Indications. In the event at any time after the Effective Date, Licensor possesses, acquires, or regains rights to Develop, sell, offer for sale, use, export and/import the Licensed Product for the Excluded Indications, such Excluded Indications shall be automatically included in the Field, subject to Section F.5 of the GNE Ex-US License. [*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
Sample 1
Excluded Indications. In the event at any time after the Effective Date, Licensors possess, acquire, or regain rights to Develop, sell, offer for sale, use, export and/import the Licensed Product for the Excluded Indications, such Excluded Indications shall be automatically included in the Field.
Sample 1

Related to Excluded Indications

  • Excluded Inventions The provisions of Section 2.1 shall not apply to Inventions which fulfill all of the following criteria:

  • Commercialization Activities Within North America, the Parties will use Commercially Reasonable Efforts to Commercialize Licensed Products in the Field. In addition, within North America and subject to Section 2.7.6, the Parties will use Commercially Reasonable Efforts to conduct the Commercialization activities assigned to them pursuant to the Commercialization Plan/Budget, including the performance of detailing in accordance therewith. In conducting the Commercialization activities, the Parties will comply with all Applicable Laws, applicable industry professional standards and compliance policies of Celgene which have been previously furnished to Acceleron, as the same may be updated from time to time and provided to Acceleron. Neither Party shall make any claims or statements with respect to the Licensed Products that are not strictly consistent with the product labeling and the sales and marketing materials approved for use pursuant to the Commercialization Plan/Budget.

  • Competing Products The provisions of Section 21 are set forth on attached Exhibit H and are incorporated in this Section 21 by this reference.

  • 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 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.

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

  • 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.

  • 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.

  • 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.

  • Combination Product The term “

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