Regulatory Plan. (i) The Parties acknowledge that the Regulatory Plan is based upon the Development of the Memantine-Donepezil FDC Product [*] to support [*] for such Memantine-Donepezil FDC Product, and the Parties intend to conduct the Initial Development Plan, using the efforts specified in Section 4.1, to submit [*] based upon the results of such conduct of the Initial Development Plan.
Regulatory Plan. Within the time period set forth in Section 5.1(c)(i), Chiron shall prepare and deliver to Cubist one regulatory plan for the Territory, which regulatory plan shall set forth Chiron’s plan, strategy and proposed activities to obtain Regulatory Approval in the Territory for the Launch Indication(s) (the “Regulatory Plan”). The Regulatory Plan may include, as appropriate and without limitation, the following elements:
Regulatory Plan. Brii Bio shall develop, in its sole discretion, a regulatory plan for each Licensed Product that describes the regulatory actions to be taken by Brii Bio to obtain Marketing Approval in the Field in the Licensed Territory with respect to such Licensed Product. The regulatory plan shall be submitted to the Joint Steering Committee for review and comment, and Brii Bio shall consider such comments in good faith. Such regulatory plan shall be updated to reflect regulatory activities and changes agreed upon by the JSC at least once per year, until such time as the applicable Licensed Product receives Marketing Approval.
Regulatory Plan. BPS shall execute any mutually agreed upon Regulatory Plan and deliver two (2) originals of the Regulatory Plan to NUVELO. If a Regulatory Plan is acceptable to NUVELO, NUVELO shall sign both originals of the Regulatory Plan and return one (1) fully executed original to BPS. Upon full execution, the Regulatory Plan is incorporated herein by reference and made a part of this Agreement. Neither Party shall have any obligation with respect to the performance of regulatory services or the provision of regulatory support for a Drug Product until the Parties have executed a Regulatory Plan in writing for such Drag Product. For the avoidance of doubt, any and all obligations set forth in the Quality Agreement are not and shall not be deemed to be regulatory services or regulatory support requiring the execution of a Regulatory Plan. In the event of a conflict between any of the provisions of this Agreement and the Regulatory Plan, the provisions of this Agreement govern.
Regulatory Plan. If requested by Client, Baxter shall provide regulatory services in connection with obtaining Regulatory Approval for a Product. Baxter will not be required to conduct regulatory services for a Product, and Client will not be required to pay for services or costs, until (i) the Regulatory Plan for such Product has been agreed upon by the Parties or (ii) THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. Client has issued to Baxter a purchase order or some other written approval by a Genocea Vice President or Genocea officer senior to a Vice President for such services or costs.
Regulatory Plan. All regulatory activities with respect to the Product in the Territory will be conducted in accordance with a comprehensive regulatory plan (as amended in accordance with this Agreement, the “Regulatory Plan”) prepared by Terumo and agreed upon by the Parties; provided, however, that not achieving the activities set forth in the Regulatory Plan will not constitute a breach of this Agreement as long as Terumo has exerted its Commercially Reasonable Efforts to perform such activities.
Regulatory Plan. All Regulatory Activities with respect to the Product in the countries and Country Group(s) in the Territory, as applicable, will be conducted in accordance with a comprehensive regulatory plan, which shall include timelines for the achievement of the Regulatory Activities including but not limited to submission of the IDE, execution of the Clinical Trial, submission of market approval applications (e.g. PMA) and descriptions of the Parties’ roles with respect to all such Regulatory Activities, including without limitation the execution of separate services agreements which set out specific Regulatory Activities that Medtronic (the “Services Agreement”) and certain third-party service providers will perform on behalf of the sponsor of the Clinical Trial and document any transfers of regulatory responsibilities from the sponsor to Medtronic and such other service providers (as amended in accordance with this Agreement, the “Regulatory Plan”) it being understood that such undertaking of any allocated responsibility is not intended as an assurance of results. The Regulatory Plan as of the Effective Date is attached hereto as Exhibit D. Without limiting anything in this Section 6.1, it is the intention of the Parties to seek Regulatory Approval for the Primary Field of Use and to use Commercially Reasonable Efforts to engage in each Party’s respective Regulatory Activities in support of obtaining such Regulatory Approvals, in the applicable countries and Country Group(s), as described in the Regulatory Plan. For the avoidance of doubt, Orchestra will be the regulatory sponsor of the Clinical Trial involving U.S., European Union, and Japan. Orchestra will be responsible for obtaining Regulatory Approvals required for the Clinical Trial and Medtronic will be responsible for seeking FDA, CE Mark, and PDMA Regulatory Approvals for the Commercial Device as per the Regulatory Plan. Any changes and updates to the Regulatory Plan must be approved by the JSC, subject to the decision-making procedures set forth in Section 4.5 and the rights set forth in Section 164.3 hereof. The budget for the Regulatory Plan shall be proposed, approved and amended as necessary from time to time by the JSC.
Regulatory Plan. [*] [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Schedule 2.6
Regulatory Plan. A. For the EU Member States:
Regulatory Plan. The objective of the Regulatory Plan is the expeditious regulatory approval of the Product in the Territory. SJ Pharma will use commercially reasonable efforts to secure and subsequently will own all necessary regulatory approvals for the Products in the Territory. SJ Pharma will bear the cost of gaining said regulatory approvals. Stellar will provide any and all scientific data and documentation in its possession and any and all ongoing assistance to SJ Pharma for said regulatory approvals at Stellar’s expense. All data generated on or on behalf of SJ Pharma for the approval of the Products in the Territory shall be shared with Stellar in its entirety for Stellar’s use outside the Territory. All data generated on or on behalf of Stellar for the approval of the Products in the Territory shall be shared with SJ Pharma in its entirety for SJ Pharma’s use inside the Territory. Upon receipt of all necessary information, SJ Pharma shall promptly apply for and/or file and thereafter maintain all necessary and desirable marketing and sales authorizations for the Products in the Territory and/or any supplements to such marketing and sales authorizations. If any other United States government or other regulatory submissions or agreements in the Territory are required for SJ Pharma to import the Products for sale and distribution in the Territory, SJ Pharma shall be responsible for completing such submissions. Stellar shall be responsible for the completion of all Canadian documents necessary to export the Products into the Territory. A Regulatory Approval Team will exist until the first commercial launch of the Products in the Territory or as otherwise agreed to by the parties, the composition and responsibilities of which are more specifically defined in Appendix 2. SJ will control the strategy and tactics to obtain regulatory approval. Stellar will be represented on the Regulatory Approval Team.
