Moderna Regulatory Responsibilities Related to Manufacture Sample Clauses

Moderna Regulatory Responsibilities Related to Manufacture. Consistent with the provisions of Section 4.10 of the A&R Services and Collaboration Agreement, Moderna will, at its sole cost and expense, obtain and maintain all approvals, licenses, registrations, or authorizations (other than the Regulatory Approval for a Product) that are necessary or useful in connection with the Manufacture of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna. In addition, [***], Moderna will, when and as requested by AstraZeneca, prepare the Chemistry, Manufacturing, and Controls (“CMC”) and other Manufacturing provisions with respect to all Regulatory Filings for, or that are otherwise necessary to obtain and maintain, Regulatory Approvals for the Products, including with respect to any Manufacture and supply of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna pursuant to Section 4 of the A&R Services and Collaboration Agreement, including any amendments with respect thereto as AstraZeneca may request from time to time. As set forth in greater detail in Section 4.10 of the A&R Services and Collaboration Agreement, the CMC section of a Regulatory Approval for a Product may reference Moderna’s DMF for such Product.
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Moderna Regulatory Responsibilities Related to Manufacture. Consistent with the provisions of Section 4.10, Moderna will, at its sole cost and expense, obtain and maintain all approvals, licenses, registrations, or authorizations (other than the Regulatory Approval for a Product) that are necessary or useful in connection with the Manufacture of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna. In addition, [***], prepare the Chemistry, Manufacturing, and Controls (“CMC”) and other Manufacturing provisions with respect to all Regulatory Filings for, or that are otherwise necessary to obtain and maintain, Regulatory Approvals for the Products, including with respect to any Manufacture and supply of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna pursuant to Section 4, including any amendments with respect thereto [***]. As set forth in greater detail in Section 4.10, the CMC section of a Regulatory Approval for a Product may reference Moderna’s DMF for such Product. A&R SERVICES AND COLLABORATION AGREEMENT
Sample 1
Moderna Regulatory Responsibilities Related to Manufacture. Consistent with the provisions of Section 4.10, Moderna will, at its sole cost and expense, obtain and maintain all approvals, licenses, registrations, or authorizations (other than the Regulatory Approval for a Product) that are necessary or useful in connection with the Manufacture of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna. In addition, [***], prepare the Chemistry, Manufacturing, and Controls (“CMC”) and other Manufacturing provisions with respect to all Regulatory Filings for, or that are otherwise necessary to obtain and maintain, Regulatory Approvals for the Products, including with respect to any Manufacture and supply of Collaboration mRNA Constructs, Product Candidates, and Products by or on behalf of Moderna pursuant to Section 4, including any amendments with respect thereto [***]. As set forth in greater detail in Section 4.10, the CMC section of a Regulatory Approval for a Product may reference Moderna’s DMF for such Product. [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED A&R SERVICES AND COLLABORATION AGREEMENT
Sample 1

Related to Moderna Regulatory Responsibilities Related to Manufacture

  • Regulatory Responsibility The preparation, filing, prosecution and maintenance of INDs, BLAs and other regulatory filings required to be filed with any Regulatory Authority with regard to each Product will be in the name of and the responsibility of Alexion. Alexion shall own the Regulatory Approvals. The costs incurred by the Parties in the preparation, filing and submission of such regulatory filings will be deemed Development Expenses and subject to the terms of Section 3.6. Except as otherwise provided in an applicable Development Plan, Alexion shall oversee, monitor and coordinate all regulatory actions, communications and filings with and submissions, including filings and submissions of supplements and amendments thereto, to Regulatory Authorities with respect to each Product and shall give XOMA a reasonable opportunity for prior review of all such material communications, filings and submissions.

  • Regulatory Responsibilities The Parties will share responsibility for leading regulatory matters relating to the SYNGAP1 Co-Co Products, as described in this Section 6.9 (each Party, when designated as provided herein to provide such leadership with respect to designated activities is the “Lead Regulatory Party” with respect to such activities). With respect to each SYNGAP1 Co-Co Product, Acadia shall (x) lead the overall strategy for obtaining Regulatory Approval of such SYNGAP1 Co-Co Product (including labeling for such SYNGAP1 Co-Co Product), including by selecting the jurisdictions within which XXXx will be pursued and Execution Version the timing and order in which such approvals will be sought (“Regulatory Strategy”), and will be the Lead Regulatory Party with respect to such strategic activities with respect to such SYNGAP1 Co-Co Product, (y) be the Lead Regulatory Party with respect to the submission of any MAA for such SYNGAP1 Co-Co Product, and (z) following the first Regulatory Approval of such SYNGAP1 Co-Co Product, be the Lead Regulatory Party in connection with such SYNGAP1 Co-Co Product and with respect to Commercialization and regulatory activities (including post-marketing studies). Subject to the foregoing, the JSC shall designate a Party to lead all other pre-Regulatory Approval regulatory matters relating to each SYNGAP1 Co-Co Product in accordance with the applicable SYNGAP1 Co-Development Plan (each Party in such capacity will be deemed the Lead Regulatory Party with respect to such activities). The Lead Regulatory Party shall be responsible for (i) filing for in its name, and owning, all Regulatory Materials relating to regulatory activities with respect to such SYNGAP1 Co-Co Product in the relevant country, (ii) overseeing, monitoring, and coordinating all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority with respect to such activities; and (iii) interfacing, corresponding, and meeting with each Regulatory Authority with respect to such activities, in each case consistent with the Regulatory Strategy and applicable SYNGAP1 Co-Development Plan or SYNGAP1 Co-Commercialization Plan.

  • Specific Responsibilities In addition to its overall responsibility for monitoring and providing a forum to discuss and coordinate the Parties’ activities under this Agreement, the JSC shall in particular:

  • Joint Responsibilities 2.1.1 University and Affiliate each will identify, and notify each other of, a person responsible for serving as its liaison during the course of this affiliation. The appointment of liaisons shall be subject to mutual approval of the parties.

  • Development Responsibilities Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to operational responsibilities under each Development Plan:

  • Joint Responsibility If the Seller determines that the Interface Problem is attributable partially to the design of a Warranted Part and partially to the design of any Supplier Part, the Seller will, if so requested by the Buyer, seek a solution to the Interface Problem through cooperative efforts of the Seller and any Supplier involved. The Seller will promptly advise the Buyer of such corrective action as may be proposed by the Seller and any such Supplier. Such proposal will be consistent with any then existing obligations of the Seller hereunder and of any such Supplier towards the Buyer. Such corrective action, unless reasonably rejected by the Buyer, will constitute full satisfaction of any claim the Buyer may have against either the Seller or any such Supplier with respect to such Interface Problem.

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • Primary Responsibility The Company acknowledges that to the extent Indemnitee is serving as a director on the Company’s board of directors at the request or direction of a venture capital fund or other entity and/or certain of its affiliates (collectively, the “Secondary Indemnitors”), Indemnitee may have certain rights to indemnification and advancement of expenses provided by such Secondary Indemnitors. The Company agrees that, as between the Company and the Secondary Indemnitors, the Company is primarily responsible for amounts required to be indemnified or advanced under the Company’s certificate of incorporation or bylaws or this Agreement and any obligation of the Secondary Indemnitors to provide indemnification or advancement for the same amounts is secondary to those Company obligations. To the extent not in contravention of any insurance policy or policies providing liability or other insurance for the Company or any director, trustee, general partner, managing member, officer, employee, agent or fiduciary of the Company or any other Enterprise, the Company waives any right of contribution or subrogation against the Secondary Indemnitors with respect to the liabilities for which the Company is primarily responsible under this Section 15. In the event of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Company’s certificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee for indemnification or advancement of expenses under the Company’s certificate of incorporation or bylaws or this Agreement or, to the extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to the amounts paid. The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15.

  • Monitoring Responsibilities The Custodian shall furnish annually to the Fund, during the month of June, information concerning the foreign sub-custodians employed by the Custodian. Such information shall be similar in kind and scope to that furnished to the Fund in connection with the initial approval of this Contract. In addition, the Custodian will promptly inform the Fund in the event that the Custodian learns of a material adverse change in the financial condition of a foreign sub-custodian or any material loss of the assets of the Fund or in the case of any foreign sub-custodian not the subject of an exemptive order from the Securities and Exchange Commission is notified by such foreign sub-custodian that there appears to be a substantial likelihood that its shareholders' equity will decline below $200 million (U.S. dollars or the equivalent thereof) or that its shareholders' equity has declined below $200 million (in each case computed in accordance with generally accepted U.S. accounting principles).

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