Co-Commercialization Agreement Sample Clauses

Co-Commercialization Agreement. Following submission of the first NDA for a Product or at such earlier time as AstraZeneca may request, the Parties will negotiate and enter into an agreement (the “Co-Commercialization Agreement”) governing the Parties’ conduct of activities for Commercializing the Product in the U.S. The Co-Commercialization Agreement will be consistent with the terms of this Article 5, Exhibit I, other terms agreed by the Parties, and other customary terms for such an agreement.
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Co-Commercialization Agreement. 9.2.1 Not later than [***] after expiry of the last Opt-Out Right with respect to a given Joint Selected Candidate without exercise by Immunocore of the applicable Immunocore Co-Development Option, the Parties shall negotiate in good faith and agree to the terms of an agreement, or an appropriate amending and restating of this Agreement, covering the profit/loss sharing and governance that will apply to Products containing a Joint Selected Candidate, and including terms related to the possible detailing of such Product(s) by Immunocore (subject to sub-clauses (i) – (iii) below) (such agreement or amended and restated iteration of this Agreement, “Co-Commercialization Agreement”). Such Co-Commercialization Agreement, or amending and restating of this Agreement, shall include the principles set out in Exhibit G, and, until the Parties agree regarding the terms and conditions of such agreement or amending and restating of this Agreement, Exhibit G (in conjunction with this Agreement) shall control the rights and obligations of the Parties with respect to the commercialization of Products containing a Joint Selected Candidate. Without limiting the foregoing, the Parties acknowledge and agree that Immunocore’s right to detail, or otherwise co-promote, the relevant Joint Selected Candidate or Back-Up Compound shall be subject to: [***]. In the event that the foregoing sub-clauses (i), (ii) and (iii) are not all satisfied, then Immunocore shall have no right to detail, or otherwise co-promote, any Products containing a Joint Selected Candidate.
Co-Commercialization Agreement. The first time Denali exercises the Co-Commercialization Option for a CNS Product in a Co-Commercialization Country, the Parties shall negotiate in good faith terms and conditions of a co-commercialization agreement pursuant to which they will conduct the Co-Commercialization Activities for such CNS Product in the applicable country (“Co-Commercialization Agreement”) and, to the extent Denali exercises its Co‑Commercialization Option for any other CNS Product in such Co-Commercialization Country, the applicable Co-Commercialization Agreement shall be updated to include such CNS Product. The Co-Commercialization Agreement will contain the terms and conditions set forth on Schedule 5.2.4 and such other terms as are agreed upon by the Parties; provided that in the event of any conflict between the terms of a Co-Commercialization Agreement and the terms of this Agreement (including Schedule 5.2.4), the terms of this Agreement shall control. The Parties shall use Commercially Reasonable Efforts to enter into the Co-Commercialization Agreement no later than [***] following the date upon which Denali exercises the Co‑Commercialization Option, or *** Certain information in this agreement has been omitted and filed separately with the Securities and Exchange Commission. [***] indicates that text has been omitted and is the subject of a confidential treatment request. Confidential such later date as the Parties may agree in writing. Until the Parties enter into the Co-Commercialization Agreement, the terms of this Agreement, including those set forth in Schedule 5.2.4, shall govern the Parties’ Co-Commercialization Activities (during such period, references in Schedule 5.2.4 to the Co-Commercialization Agreement shall be deemed to be references to Schedule 5.2.4) and, for the avoidance of doubt, Denali shall have the right to conduct Co-Commercialization Activities in accordance with the terms of this Agreement.
Co-Commercialization Agreement. Within [**]after Immatics exercises the Co-Commercialization Option for Licensed Products, Immatics and BMS will promptly negotiate in good faith an agreement (the “Co-Commercialization Agreement”), which will contain the business terms set forth on Schedule 6.3.2 (Co-Commercialization Agreement Terms) and other standard contractual provisions. Immatics shall not perform any of its co-Commercialization activities or otherwise Commercialize Licensed Products until the Parties have executed such Co-Commercialization Agreement. Certain confidential information contained in this document, marked by [**], has been omitted because Immatics N.V. has determined that the information (i) is not material and (ii) is the type that Immatics N.V. customarily and actually treats as private or confidential.
Co-Commercialization Agreement. For each Collaboration Lead Compound, the Parties will negotiate in good faith and finalize an agreement for the co-promotion or co-marketing, as the case may be, of all associated Products (“Co-Commercialization Agreement”), within [ * ] after the [ * ] for the [ * ]. The basis for the Co-Commercialization Agreement shall be the terms and conditions contained in the Heads of Co-Commercialization Agreement set forth in Appendix E [ * ]. Anything in this Agreement to the contrary notwithstanding, if the Parties do not execute a Co-Commercialization Agreement for the relevant Product within [ * ]: (i) the [ * ] shall continue [ * ] the Parties; and (ii) the Parties shall [ * ].

Related to Co-Commercialization Agreement

  • Collaboration Agreement The Collaboration Agreement shall not have been terminated in accordance with its terms and shall be in full force and effect.

  • 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 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:

  • 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).

  • 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.

  • 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.

  • Development Agreement As soon as reasonably practicable following the ISO’s selection of a transmission Generator Deactivation Solution, the ISO shall tender to the Developer that proposed the selected transmission Generator Deactivation Solution a draft Development Agreement, with draft appendices completed by the ISO to the extent practicable, for review and completion by the Developer. The draft Development Agreement shall be in the form of the ISO’s Commission-approved Development Agreement for its reliability planning process, which is in Appendix C in Section 31.7 of Attachment Y of the ISO OATT, as amended by the ISO to reflect the Generator Deactivation Process. The ISO and the Developer shall finalize the Development Agreement and appendices as soon as reasonably practicable after the ISO’s tendering of the draft Development Agreement. For purposes of finalizing the Development Agreement, the ISO and Developer shall develop the description and dates for the milestones necessary to develop and construct the selected project by the required in-service date identified in the Generator Deactivation Assessment, including the milestones for obtaining all necessary authorizations. Any milestone that requires action by a Connecting Transmission Owner or Affected System Operator identified pursuant to Attachment P of the ISO OATT to complete must be included as an Advisory Milestone, as that term is defined in the Development Agreement. If the ISO or the Developer determines that negotiations are at an impasse, the ISO may file the Development Agreement in unexecuted form with the Commission on its own, or following the Developer’s request in writing that the agreement be filed unexecuted. If the Development Agreement is executed by both parties, the ISO shall file the agreement with the Commission for its acceptance within ten (10) Business Days after the execution of the Development Agreement by both parties. If the Developer requests that the Development Agreement be filed unexecuted, the ISO shall file the agreement at the Commission within ten (10) Business Days of receipt of the request from the Developer. The ISO will draft, to the extent practicable, the portions of the Development Agreement and appendices that are in dispute and will provide an explanation to the Commission of any matters as to which the parties disagree. The Developer will provide in a separate filing any comments that it has on the unexecuted agreement, including any alternative positions it may have with respect to the disputed provisions. Upon the ISO’s and the Developer’s execution of the Development Agreement or the ISO’s filing of an unexecuted Development Agreement with the Commission, the ISO and the Developer shall perform their respective obligations in accordance with the terms of the Development Agreement that are not in dispute, subject to modification by the Commission. The Connecting Transmission Owner(s) and Affected System Operator(s) that are identified in Attachment P of the ISO OATT in connection with the selected transmission Generator Deactivation Solution shall act in good faith in timely performing their obligations that are required for the Developer to satisfy its obligations under the Development 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.

  • Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)

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