Territory Specific Development Sample Clauses

Territory Specific Development. To the extent that additional Development is necessary solely to obtain the Product Registration in the Territory (“Territory Development”), ** shall supplement the current Development Plan with a budget setting forth the reasonable costs for conducting the Territory Development specific activities (“Territory Development Costs”) and shall submit such supplement to Fidopharm for its consent and upon approval of such Territory Development Costs by Fidopharm, Fidopharm shall reimburse such costs as they are incurred.
Sample 1
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Territory Specific Development. If the Additional Development conducted pursuant to Section 4.2.1(b) (Licensee Proposal) or Section 4.2.1(c) (Akebia Proposal) is for the sole purpose of [***], then [***]% of the total Development costs will be allocable to the Territory.
Sample 1
Territory Specific Development. Subject to Section 4.1 (Current Global Development) and this Section 4.2 (Territory-Specific Development), [***] will be responsible for all Territory-Specific Development at its [***], including all [***]. Except as may otherwise be permitted under this Agreement (including pursuant to Section 4.3 (Additional Development) and as provided in Section 3.1.5(b) (Specific Responsibilities of the JSC)), [***] will conduct Development of the Licensed Compound and the Licensed Products only (a) in accordance with the applicable Territory-Specific Development Plan that has been [***] by the JDC and the JSC, or, as applicable, any portion thereof that has been [***] by the JSC as set forth in Section 3.1.5(f) (Specific Responsibilities of the JSC), in each case, as required under Section 4.2.1 (Territory-Specific Development Plan), and (b) only for the [***], unless the Parties agree to conduct [***] pursuant to Section 4.3.1 (Approval of Additional Development). [***] will use Commercially Reasonable Efforts to Develop, and obtain and maintain Regulatory Approval and Reimbursement Approval (where required) for, the Licensed Products in the Initial Indications in the Territory. In no event will Akebia have the right or authority, [***] or otherwise, to require Licensee to conduct any [***] Development, but Akebia may [***] Licensee from conducting certain [***] Development pursuant to the exercise of its [***] in accordance with Section 1.11(d) (Akebia Reserved Disputes), in each case, at any time.
Sample 1
Territory Specific Development. Subject to this Section 4.1 (Territory-Specific Development), Licensee will be responsible for all Territory-Specific Development at its cost and expense. Except as may otherwise be permitted under this Agreement, Licensee will solely conduct Territory-Specific Development of the Licensed Product that has been reviewed, discussed, and approved by the JSC, in each case and will not conduct any other Development activities with the Licensed Product.
Sample 1
Territory Specific Development 
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Related to Territory Specific Development

  • Manufacturing Technology Transfer With respect to each Technology Transfer Product, upon AbbVie’s written request after the Inclusion Date for the Included Target to which such Technology Transfer Product is Directed, Morphic shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party manufacturer) of all Morphic Know-How and Joint Know-How relating to the then-current process for the Manufacture of such Technology Transfer Product (the “Manufacturing Process”) and to implement the Manufacturing Process at facilities designated by AbbVie (such transfer and implementation, as more fully described in this Section 5.3, the “Manufacturing Technology Transfer”). To assist with the Manufacturing Technology Transfer, Morphic will make its personnel reasonably available to AbbVie during normal business hours for up to [***] FTE hours with respect to each Included Target (in each case, free of charge to AbbVie) to transfer and implement the Manufacturing Process under this Section 5.3. Thereafter, if requested by AbbVie, Morphic shall continue to perform such obligations; provided, that AbbVie will reimburse Morphic for its full-time equivalent (FTE) costs (for clarity, in excess of [***] FTE hours) and any reasonable and verifiable out-of-pocket costs incurred in providing such assistance. CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED.

  • 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.

  • Clinical Development (a) Stellartech shall design, develop and construct a Clinical Unit for each of the Thermage Disposable Device and the Thermage Generator, and any required component or subassembly thereof and shall deliver such Clinical Units to Thermage in accordance with the Development Program; (b) Stellartech shall deliver to Thermage such other Deliverables as are contemplated by the Development Program in accordance with the Development Program; and (c) as requested by Thermage and automatically at the conclusion of the Development Program, Stellartech, so long as Thermage is not in breach of its material obligation hereunder, shall deliver in writing to Thermage any and all data and information held by or in the control of Stellartech which is necessary or useful to obtain regulatory approval of the Products in the United States or any foreign country.

  • Development Activities NovaDel shall not be required to commence any Development Activities until Licensee has paid at least twenty-five percent (25%) of the non-refundable License Fee described in Section 4.4.

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Development Work Do, or cause to be done, such development and other work as may be reasonably necessary to protect from diminution and production capacity of the Mortgaged Property and each producing well thereon.

  • 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 Plan As defined in Section 3.2(a).

  • 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:

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