Territory Development Activities definition

Territory Development Activities means those Development Activities consistent with the Development Plan that are (i) necessary solely for obtaining or maintaining Regulatory Approval for the Product in the Field in the Territory and (ii) post-Regulatory Approval-filing date Development Activities for the Product in the Field in the Territory. Notwithstanding the foregoing, in the event that Licensee requests that Amarin perform certain Development Activities, within the Territory, which are not necessary solely for obtaining Regulatory Approval in the Territory, and Amarin agrees at its sole discretion to perform such activities within the Territory, then such activities as are conducted in the Territory shall be deemed Territory Development Activities.

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Territory Development Activities means those Development Activities that are (i) necessary solely for obtaining or maintaining Regulatory Approval for Product in the Field in the Territory and (ii) post-Regulatory Approval filing date Development Activities for Product in the Field in the Territory. For clarity, Territory Development Activities include any Territory Clinical Arm (Multinational Study).

Territory Development Activities means those Development Activities that are (i) necessary solely for obtaining or maintaining Regulatory Approval for the Finished Product in the Field in any given country in the Territory and (ii) post-Regulatory Approval filing date Development Activities in any given country in the Field in the Territory. Notwithstanding the foregoing, in the event that Actelion requests that Auxilium perform certain Development Activities, within the Territory, which are not necessary solely for obtaining or maintaining Regulatory Approval in the Territory, and Auxilium agrees at its sole discretion to perform such activities within the Territory, then such activities as are conducted in any given country in the Territory shall be deemed Territory Development Activities. For clarity, those Development Activities which Auxilium proposes (absent Actelion’s request) to conduct in the Territory shall not be included in the definition of Territory Development Activities, and shall therefore be deemed General Development Activities.

Examples of Territory Development Activities in a sentence

• Any amendment to the Development Plan for the Compound and Products under this Agreement, including the Ovid Ongoing Trials, Licensee Territory Development Activities for registrational purposes, all Joint Development Activities, and all Independent Development Activities shall be conducted pursuant to a comprehensive written updated (from time to time) Development Plan (the “Amended Development Plan”), which shall be incorporated by reference into this Agreement.

• Ono shall use Commercially Reasonable Efforts to carry out the Territory Development Activities set forth in the Development Plan in accordance with the time frames set forth therein.

• Licensee shall be solely responsible for all Development Costs incurred in connection with Licensee Territory Development Activities, except as provided in Section 4.2(c)(ii) with respect to the Additional Pivotal Study.

• Ono shall conduct, in accordance with the Development Plan, the Territory Development Activities, including bridging studies, clinical studies, Phase IV Clinical Studies (and other post-Regulatory Approval studies).

• Amarin shall be given an adequate opportunity, in any event not less than [***], to comment on and approve the drafts of reports resulting from Territory Development Activities conducted under the Development Plan.

• Notwithstanding anything to the contrary herein, Licensee shall consider in good faith and incorporate Ovid’s reasonable comments on any proposed Licensee Territory Development Activities.

• Licensee shall provide the JDC with reports detailing its respective Territory Development Activities and the results thereof at least [***] prior to any JDC meeting, but in any event, on at least a Calendar Quarter basis.

• In connection with the Development of Product for use in the Field in the Territory, Ono shall conduct Territory Development Activities pursuant to a comprehensive development plan (the “Development Plan”).

• Ovid shall have the right to use Data resulting from the Licensee Territory Development Activities as necessary for Ovid or its Affiliates or licensees (other than Licensee) to comply with its regulatory reporting and compliance obligations, including safety reporting obligations, and to support its own Development, Regulatory Approval, or Commercialization of the Product in the Ovid Territory.

• In addition, Licensee shall use Commercially Reasonable Efforts to perform any Independent Development Activities of Licensee, and Licensee Territory Development Activities and file ▇▇▇▇ and seek and maintain Regulatory Approval (including Pricing and Reimbursement Approval, as applicable) for the Products throughout the Licensee Territory.

More Definitions of Territory Development Activities

Territory Development Activities means those Development Activities (other than Development Activities that have already been or are being conducted by Amarin as of the Effective Date) that are (a) necessary solely for obtaining or maintaining Regulatory Approval for the Product in the Territory for the Field and (b) post-Regulatory Approval-filing date Development Activities for the Product in the Territory for the Field. Such activities shall include, without limitation, designing, managing and conducting registration stability studies for the Product in the Territory for the Field, amending the shelf-life specifications to be in compliance with local Applicable Laws in the Territory, and assigning shelf-life/expiry dating of the Product. [***]

Territory Development Activities has the meaning given to it in Section 8.1.

Territory Development Activities means those Development Activities consistent with the Development Plan that are (i) necessary for obtaining or maintaining Regulatory Approval for the Product in the Field solely with respect to the Territory and (ii) post-Regulatory Approval-filing date Development Activities for the Product in the Field solely with respect to the Territory. Notwithstanding the foregoing, in the event that Licensee requests that VBL perform certain Development Activities within the Territory and the Parties agree that VBL shall perform such activities within the Territory in accordance with Section 4.2.1(c), then such activities as are conducted in the Territory shall be deemed Territory Development Activities.

Territory Development Activities means those Development Activities consistent with the applicable Development Plan that are (i) necessary solely for obtaining or maintaining Regulatory Approval for the Product in the Field in the Territory and (ii) post-Regulatory Approval-filing date Development Activities for the Product in the Field in the Territory. Notwithstanding the foregoing, in the event that Asahi requests that Auxilium perform certain Development Activities, within the Territory, which are not necessary solely for obtaining Regulatory Approval in the Territory, and Auxilium agrees at its sole discretion to perform such activities within the Territory, then such activities as are conducted in the Territory shall be deemed Territory Development Activities. For clarity, (i) those Development Activities which Auxilium proposes (absent Asahi’s request) to conduct in the Territory shall not be included in the definition of Territory Development Activities, and shall therefore be deemed General Development Activities, and (ii) Territory Development Activities shall not include activities associated with Territory-Specific Analytical Release Testing and Characterization.