P reparation of CMC Section and DMF Sample Clauses

P reparation of CMC Section and DMF. If not previously prepared and filed, Moderna will, at AstraZeneca’s request, prepare and file with Regulatory Authorities a DMF and provide such other information and assistance as AstraZeneca may reasonably require in connection with the completion of and submission of applications for Regulatory Approvals for Products. AstraZeneca may refer to such DMF in any filing made in connection with obtaining or maintaining a Regulatory Approval for a Product. Moderna will be responsible for assuring that during any period in which Moderna has a supply obligation to AstraZeneca for mRNA API, such DMF will be in the form appropriate for filing with the Regulatory Authorities in the United States, the European Union, Japan and such other countries as requested by AstraZeneca. Moderna will, on written request by AstraZeneca or its Affiliate or Sublicensee, provide to the requesting party and to any specified Regulatory Authority a letter, in the form reasonably required by the requesting party, acknowledging that the requesting party has a right of reference to any such DMF. [***]
Sample 1
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Related to P reparation of CMC Section and DMF

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  • Introduction and Statement of Policy The National Institutes of Health (NIH) has established NIH-designated data repositories (e.g., database of Genotypes and Phenotypes (dbGaP), Sequence Read Archive (SRA), NIH Established Trusted Partnerships) for securely storing and sharing controlled-access human data submitted to NIH under the NIH Genomic Data Sharing (GDS)

  • RECOGNITION AND SCOPE 1.01 The Company agrees to recognize the Union as the sole collective bargaining agent for employees covered by this Agreement.

  • Implementation of the Agreement Regulations of this Agreement relating to investments who investors of one Contracting Party realized before or after the entry into force of this Agreement, with what shall apply from the moment of its entry into force, provided that such investments conducted in accordance with the laws of that Party Contracting.

  • RECOGNITION AND SCOPE OF AGREEMENT a) The Company recognizes the Union as the sole and exclusive Bargaining Agent for all Production Coordinators, 1st Assistant Production Coordinators and 2nd Assistant Production Coordinators, Production Assistants (with the exception of Set and Location PA’s) and any other classifications that may be contained in Schedule A of this agreement.

  • Definition and Purpose Seniority, which is the length of an employee’s service within the bargaining unit as a whole, shall be used to distinguish between employees who would otherwise be considered equal.

  • Notification and Public Notice If either party desires to alter or amend this Agreement, it shall, not less than one hundred and twenty (120) days prior to the termination date set forth under the Duration Article, provide written notice and a proposal to the other party of said desire and the nature of the amendments, and cause the public notice provisions of law to be fulfilled.

  • Construction and Scope of Agreement The language of all parts of this Agreement shall in all cases be construed as a whole, according to its fair meaning, and not strictly for or against any party. This Agreement is the only, sole, entire, and complete agreement of the parties relating in any way to the subject matter hereof. No statements, promises, or representations have been made by any party to any other, or relied upon, and no consideration has been offered or promised, other than as may be expressly provided herein. This Assumption of Risk, Release of Claims, Indemnification, and Hold Harmless and Agreement supersedes any earlier written or oral understandings or agreements between the parties. Participant acknowledges that he/she has read this Assumption of Risk, Release of Claims, Indemnification and Hold Harmless Agreement, understands its meaning and effect, and agrees to be bound by it. Date:

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