Co-Commercialization Territory Sample Clauses

Co-Commercialization Territory. The Parties shall develop promotional materials for use in the Co-Commercialization Territory by both Parties and their Affiliates that comply with each Party’s applicable policies, SOPs, the Co-Commercialization Plan, and Applicable Laws and Regulatory Approvals. Copies of all promotional materials used by COMPANY and MorphoSys and their Affiliates in the Co-Commercialization Territory shall be archived by COMPANY and/or MorphoSys, as applicable, in accordance with applicable Laws. The promotional materials developed by the Parties shall be reviewed and approved by the JCC. The JCC shall establish and implement a review process to ensure that both Parties’ compliance officers and legal departments certify compliance of the promotional materials with applicable Laws and policies of the Parties. If the Parties cannot agree upon the content of a particular promotional material, the matter may be referred to the legal departments of the Parties, and then to the JCC for resolution, subject to the final approval of the Parties’ respective compliance officers and legal departments. If the CONFIDENTIAL Parties’ compliance officers or legal departments are unable to mutually approve the content of a particular promotional material in accordance with the immediately preceding sentence, then such promotional material shall include the content approved by the Party with the more conservative compliance or legal position regarding such content. The Parties shall jointly own all right, title and interest in and to any promotional materials created hereunder relating to the Product(s) in the Co-Commercialization Territory. Promotional material in the Co-Commercialization Territory shall include logos of MorphoSys and COMPANY (or the other entity marketing the Product) at equal size.
Sample 1
AutoNDA by SimpleDocs
Co-Commercialization Territory. Each Party (and in the case of Xxxxxx, to the extent permitted under this Definitive LRRK2 Agreement) will use Commercially Reasonable Efforts to seek and obtain Regulatory Approval for at least [***], in each case ((i) and (ii)), [***].
Sample 1
Co-Commercialization Territory. Each Party will use Commercially Reasonable Efforts to: (a) seek and obtain Regulatory Approval for at least [***] and (ii) [***], in each case ((i) and (ii)), [***]; and (b) [***]. [***] Certain information in this document has been omitted from this exhibit because it is both (i) not material and (ii) would be competitively harmful if publicly disclosed.
Sample 1
Co-Commercialization Territory. Each Party (and in the case of Denali, to the extent permitted under this Definitive LRRK2 Agreement) will use Commercially Reasonable Efforts to: (a) seek and obtain Regulatory Approval for at least [***], in each case ((i) and (ii)), [***].
Sample 1
Co-Commercialization Territory. If either Party becomes aware of any Regulatory Authority that (i) has threatened, initiated or advised any action to remove any Product for use in the Field from the market or (ii) has required or advised Alnylam, Roche, or any of their Related Parties to distribute a “Dear Doctor” letter or its equivalent regarding use of such Product in the Field (collectively, a “Product Action Concern”), in each case ((i) and (ii)) with respect to, or in, the Co-Commercialization Territory, then such Party shall notify the other Party in writing of such event within [****] Business Days (or sooner if required by Applicable Laws) after such Party becomes aware of the Product Action Concern. Following receipt of such written notice, the Parties will discuss and attempt to agree upon whether to recall or withdraw the applicable Product for use in the Field in the Co-Commercialization Territory in response to such Product Action Concern; provided, however, that if the Parties fail to agree within an appropriate time period [****].
Sample 1
Co-Commercialization Territory. Alnylam shall be responsible, either itself or through any of its Affiliates or CMOs, for the Manufacture of quantities of Products required for Commercialization (for clarity, including Post-Approval Studies) in the Co-Commercialization Territory pursuant to the Commercial Supply Agreement. No later than [****] years prior to the anticipated date of First Commercial Sale of the Product for use in the Field in the Co-Commercialization Territory (as agreed upon by the Parties through the JCC), the Parties shall negotiate in good faith and enter into a commercial supply agreement (the “Commercial Supply Agreement” and, together with the Clinical Supply Agreement, the “Supply Agreements”), for the Manufacture and supply by or on behalf of Alnylam or any of its Affiliates (including a CMO) to Roche of quantities of Products for Commercialization of the Products for use in the Field in the Co-Commercialization Territory. The Commercial Supply Agreement shall contain those terms set forth on Exhibit D (the “Commercial Supply Term Sheet”), terms consistent with the allocation of Commercial Supply Costs as part of shared Net Profits and Net Losses as set forth in Section 8.3 and the Financial Appendix, and such other reasonable customary terms agreed upon by the Parties in writing. For the avoidance of doubt, the terms and conditions to be included in the Commercial Supply Agreement shall not be subject to Roche’s or Alnylam’s final decision-making authority under Section 2.5(d)(i) or Section 2.5(d)(ii), as applicable.
Sample 1

Related to Co-Commercialization 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.

  • 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.

  • Development and Commercialization Subject to Sections 4.6 and 4.7, Fibrocell shall be solely responsible for the development and Commercialization of Fibrocell Products and Improved Products. Fibrocell shall be responsible for all costs incurred in connection with the Fibroblast Program except that Intrexon shall be responsible for the following: (a) costs of establishing manufacturing capabilities and facilities in connection with Intrexon’s manufacturing obligation under Section 4.6 (provided, however, that Intrexon may include an allocable portion of such costs, through depreciation and amortization, when calculating the Fully Loaded Cost of manufacturing a Fibrocell Product, to the extent such allocation, depreciation, and amortization is permitted by US GAAP, it being recognized that the majority of non-facilities scale-up costs cannot be capitalized and amortized under US GAAP); (b) costs of basic research with respect to the Intrexon Channel Technology and Intrexon Materials (i.e., platform improvements) but, for clarity, excluding research described in Section 4.7 or research requested by the JSC for the development of a Fibrocell Product or an Improved Product (which research costs shall be reimbursed by Fibrocell); (c) [*****]; and (d) costs of filing, prosecution and maintenance of Intrexon Patents. The costs encompassed within subsection (a) above shall include the scale-up of Intrexon Materials and related active pharmaceutical ingredients for clinical trials and Commercialization of Fibrocell Products undertaken pursuant to Section 4.6, which shall be at Intrexon’s cost whether it elects to conduct such efforts internally or through Third Party contractors retained by either Intrexon or Fibrocell (with Intrexon’s consent).

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

  • 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 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:

  • 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.

  • Joint Commercialization Committee As of the Effective Date, the Parties have established a joint commercialization committee (the “Joint Commercialization Committee” or the “JCC”), composed of up to [ * ] representatives of each Party, to monitor and discuss the Commercialization of Products at the operational level. Each JCC representative shall have knowledge and expertise in the commercialization of products similar to Products. The JCC shall in particular:

  • Commercialization Plan On a Product by Product basis, not later than sixty (60) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory, the MSC shall prepare and approve a rolling multiyear (not less than three (3) years) plan for Commercializing such Product in the Copromotion Territory (the "Copromotion Territory Commercialization Plan"), which plan includes a comprehensive market development, marketing, sales, supply and distribution strategy for such Product in the Copromotion Territory. The Copromotion Territory Commercialization Plan shall be updated by the MSC at least once each calendar year such that it addresses no less than the three (3) upcoming years. Not later than thirty (30) days after the filing of the first application for Regulatory Approval of a Product in the Copromotion Territory and thereafter on or before September 30 of each calendar year, the MSC shall prepare an annual commercialization plan and budget (the "Annual Commercialization Plan and Budget"), which plan is based on the then current Copromotion Territory Commercialization Plan and includes a comprehensive market development, marketing, sales, supply and distribution strategy, including an overall budget for anticipated marketing, promotion and sales efforts in the upcoming calendar year (the first such Annual Development Plan and Budget shall cover the remainder of the calendar year in which such Product is anticipated to be approved plus the first full calendar year thereafter). The Annual Commercialization Plan and Budget will specify which Target Markets and distribution channels each Party shall devote its respective Promotion efforts towards, the personnel and other resources to be devoted by each Party to such efforts, the number and positioning of Details to be performed by each Party, as well as market and sales forecasts and related operating expenses, for the Product in each country of the Copromotion Territory, and budgets for projected Pre-Marketing Expenses, Sales and Marketing Expenses and Post-Approval Research and Regulatory Expenses. In preparing and updating the Copromotion Territory Commercialization Plan and each Annual Commercialization Plan and Budget, the MSC will take into consideration factors such as market conditions, regulatory issues and competition.

  • Commercialization Diligence Upon receipt of the Marketing Authorization for a Licensed Product in the Field in a given Region in the Territory, Lian (directly, or through its Affiliates, Sublicensees or contractors) will use Commercially Reasonable Efforts to Commercialize such Licensed Product in the Field in such Region in the Territory. Lian will have sole decision-making authority and discretion with respect to Commercializing the Licensed Product in the Field in the Territory. [***].

Time is Money Join Law Insider Premium to draft better contracts faster.