Territory Specific Development Clause Samples

The Territory-Specific Development clause defines the geographic scope within which certain development activities, rights, or obligations apply under an agreement. Typically, this clause outlines which party is responsible for developing, marketing, or distributing a product or service in specified regions or countries, and may set unique requirements or restrictions for each territory. By clearly delineating territorial boundaries and responsibilities, the clause helps prevent disputes over market rights and ensures that each party understands their obligations in different jurisdictions.
Territory Specific Development. To the extent that additional Development is necessary solely to obtain the Product Registration in the Territory (“Territory Development”), Omnipharm 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.
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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.
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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.
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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.
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Territory Specific Development 
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Related to Territory Specific Development

  • Manufacturing Technology Transfer (a) If Edge requests that Oakwood assist and cooperate with Edge in connection with knowledge transfer to Edge, or an Affiliate or a Third Party designee of Edge, in each case, with respect to Information pertaining to the Manufacture of the Product in Oakwood’s possession or Control, Oakwood shall reasonably assist and cooperate with Edge with respect to such knowledge transfer to Edge or its designee in accordance with this Section 5.4 (such transfer, the “Manufacturing Process Knowledge Transfer”) (which shall not, for clarity, constitute an assignment by Oakwood to Edge or its designee of any Oakwood Background IP or Oakwood Project IP). Edge shall pay Oakwood for its reasonable, out-of-pocket expenses incurred in the performance of its activities under this Section 5.4 unless the Manufacturing Process Knowledge Transfer is a response by Edge to a breach by Oakwood of its supply obligations hereunder, in which case Oakwood shall bear all of its own expenses. (b) Within sixty (60) days after Edge notifies Oakwood that it is exercising Manufacturing Process Knowledge Transfer rights under this Section 5.4, Oakwood shall deliver to Edge or its designee copies of the then-current Manufacturing Process for the Product and any other information reasonably required in order to Manufacture the Product, including master Batch records, analytical methods and any other Manufacturing records. During such period, and following the delivery of the foregoing records, Oakwood shall take, and shall cause its Affiliates and subcontractors to take, all action and to do all things reasonably necessary, proper or advisable to complete the Manufacturing Process Knowledge Transfer, including providing Edge or its designee with reasonable access to Oakwood’s personnel for telephone or in person consultations regarding the Manufacture of the Product and making available such other resources as reasonably necessary to enable Edge or its designee to Manufacture the Product. (c) Without limitation to the foregoing, Oakwood shall cooperate with and assist Edge in the transfer of any analytical test methods with respect to the Product or the Manufacturing Process for the Product to Edge or its designee. Such transfer shall be conducted in compliance with USP 1224 “Transfer of Analytical Procedures” and with the FDA guidance of July 2015 “Analytical Procedures and Methods Validation for Drugs and Biologics”.