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.
(ii) In the event that [*] any modification to the Regulatory Plan that would result in [*] or [*], [*] or [*] or [*] for the Memantine-Donepezil FDC Product (excluding [*]), as compared with the Regulatory Plan in existence as of the Effective Date (a “Regulatory Plan Change”), the JDC may amend the Regulatory Plan accordingly in good faith and [*]. In the event any Regulatory Plan Change requires [*], for the [*] Memantine-Donepezil FDC Product, the JDC shall [*].
(iii) In addition to a Regulatory Plan Change, Forest may amend the Regulatory Plan in good faith and [*]; provided that [*] (A) such amendment by Forest (unless it results from a Regulatory Plan Change) or (B) [*], in each case ((A) or (B)) shall [*].
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, and all future updates and revisions to the regulatory plan, will be presented and discussed at the JSC, and Brii Bio shall consider any comments in good faith.
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. 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.
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. For the EU Member States:
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:
(i) Chiron’s general strategy for seeking Regulatory Approval for the Launch Indication(s) in the Major Market Countries;
(ii) Chiron’s plans for the preparation and filing of applications for Regulatory Approval for the Launch Indication(s) in the Major Market Countries;
(iii) Chiron’s general strategy for seeking Regulatory Approval for the Launch Indication(s) in the remaining countries of the Territory, however such outline may at Chiron’s sole discretion deal with such remaining countries individually or in the aggregate; * CONFIDENTIAL TREATMENT REQUESTED: MATERIAL HAS BEEN OMITTED AND FILED WITH THE COMMISSION
(iv) if known, a description of any clinical studies or clinical data that will be necessary in order to obtain Regulatory Approval in the countries referenced in the foregoing clauses (i)-(iii) of this Section 5.1(b), with respect to the Launch Indication(s), and a discussion of the impact of any such clinical studies or clinical data requirement on the timing of obtaining Regulatory Approval for the Launch Indication(s) in such country or countries; and
(v) the proposed timetable for obtaining anticipated Regulatory Approval for the Launch Indication(s) in the countries referenced in the foregoing clauses (i) and (ii) of this Section 5.1(b), and the countries referenced in the foregoing clause (iii) of this Section 5.1(b), individually or in the aggregate, and a discussion of the factors that could result in an acceleration or a delay of such proposed timetable. Chiron shall update the Regulatory Plan annually and provide such updated Regulatory Plan to Cubist prior to the JCT’s last scheduled meeting during the then current year. Such updated Regulatory Plan shall, at such later time as and when considered appropriate by Chiron in its sole discretion, cover, among other things, additional Licensed Products, additional indications and additional countries, considered individually or in the aggregate. Cubist shall have the right to review and comment, via the JCT, on the Regulatory Plan and any and all revisions and updates theret...
Regulatory Plan. No later than [***] following Evelo notifying ALJ in writing that the first dose in the first patient of any Phase III Clinical Trial for a Product has occurred anywhere in the world, Evelo will prepare a reasonably detailed written plan of the regulatory activities for the Products that are specific to the Territory and submit such plan to the PCC to review, discuss, and determine whether to approve (as such plan may be updated pursuant to this Section 5.1 (Regulatory Plan), the “Regulatory Plan”), including a detailed, written budget of the FTE Costs and Out-of-Pocket Expenses expected to be incurred by each Party in the performance of such activities on a Calendar Year basis (as may be updated pursuant to this Section 5.1 (Regulatory Plan), the “Regulatory Budget”). The Regulatory Plan will include all regulatory activities and anticipated meetings and other communications and correspondence with applicable Regulatory Authorities in the Territory regarding obtaining and maintaining Regulatory Approvals and Reimbursement Approvals (including preparation and submission of all BLAs for all Products in each country in the Territory) to be undertaken by each Party for the Products in the Territory and an allocation between the Parties for all such activities. The Regulatory Plan will include a longstop date for each country in the Territory by which Regulatory Approval to Commercialize a Product is expected to be achieved in that country. At least once each Calendar Year, ALJ will provide to the PCC an update to the then-current Regulatory Plan, and may provide additional updates thereto from time to time, and the PCC will review, discuss, and determine whether to approve any proposed amendment or updates to the Regulatory Plan (including any amendments to the Regulatory Budget) in accordance with Section 3.3 (Decision-Making). All updates to the Regulatory Plan must be consistent with Evelo’s global plan for obtaining and maintaining Regulatory Approvals for the Products throughout the world (as provided to ALJ by Evelo in writing from time to time). ALJ will not perform any activities related to obtaining or maintaining any Regulatory Approval or Reimbursement Approval, or any other regulatory activities, in each case, for the Products for the Territory other than in accordance with the Regulatory Plan.
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.
