Novartis Territory Sample Clauses

Novartis Territory. Novartis shall use Commercially Reasonable Efforts, including legal actions, to protect the Collaboration Intellectual Property from infringement in the Novartis Territory, and may bring such action in Idenix' name, if necessary. The costs of any such Third Party infringement action shall be borne solely by Novartis, and any and all damages (including punitive damages), fees and other amounts recovered in connection with any such Third Party infringement action shall be retained solely by Novartis.
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Novartis Territory. Novartis will lead, control and be responsible for all studies, other than the Existing Luxturna Clinical Program, that Novartis determines are necessary or desirable for Development or Commercialization in the Novartis Territory. Any such studies will be included in the Development Plan, and Novartis may conduct such studies anywhere (in Novartis’ discretion) in the Novartis Territory.
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Novartis Territory. Novartis will lead, control and be responsible for all studies other than the Existing Fovista Clinical Program that are deemed by Novartis to be necessary or desirable for Regulatory Approval and Commercialization of the Standalone Product in the Novartis Territory, for the Co-Formulated Product(s) in the Novartis Territory, for any Co-Packaged Product in the Novartis Territory, and for the Pre-Filled Syringe in the Novartis Territory, and Novartis may conduct such studies anywhere in the world (other than Phase IV Clinical Studies, which Novartis may only conduct in the Novartis Territory). [**], Ophthotech shall have the right to review and approve study designs or revisions for Development in any country worldwide of any Product (including the Pre-Filled Syringe) conducted by Novartis, and to withhold such approval based on bona fide scientific or safety concerns or concerns relating to consistency with Ophthotech’s global Development strategy for Fovista. If Ophthotech does not approve or provide input within [**] Business Days after receipt, Novartis shall consider such study design or revisions as being approved by Ophthotech and Novartis shall proceed accordingly. Following the [**], Ophthotech shall have the right to review any clinical study designs or revisions for clinical studies conducted by Novartis for Regulatory Approval in the Novartis Territory. If Ophthotech does not review or provide input on the clinical study designs necessary for Regulatory Approval in the Novartis Territory within [**] Business Days after receipt, Novartis shall consider such study design or revisions as being accepted by Ophthotech and Novartis shall proceed accordingly. Without limiting the foregoing, Novartis shall reasonably cooperate with any Ophthotech request, subject to the other provisions of this Section 4.08 and Section 4.09, to modify the Development Plan and clinical study designs to satisfy criteria necessary for Regulatory Approval in the Ophthotech Territory.
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Novartis Territory. In respect of the LdT Product, Novartis shall be the Lead Regulatory Party for the Novartis Territory, and shall own all Registration Filings (including NDAs, INDs and CTAs) and Regulatory Approvals with respect to the LdT Product in the Novartis Territory. Idenix shall not utilize the data contained in any Registration Filing with any Regulatory Authority without Novartis’ prior written consent.
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Novartis Territory 
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Related to Novartis Territory

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

  • 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 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.

  • 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.

  • Territory The territorial limits of this Agreement shall be identical with those of the Reinsured Contracts.

  • Combination Product The term “

  • 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.

  • 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.

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