DMF definition

DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

Examples of DMF in a sentence

• Moderna will, on written request by Merck 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.

• Merck and its Affiliates and Sublicensees 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 the Term, such DMF will be in the form appropriate for filing with all applicable Regulatory Authorities, including those in the United States, the European Union, Japan and such other countries as requested by Xxxxx, and such DMF shall be maintained in full force and effect by Moderna during the Term and will not be amended without the consent of Merck.

• If not previously prepared and filed, Moderna will, at Merck’s request, prepare and file with all applicable Regulatory Authorities a DMF for the Moderna mRNA API and Moderna shall also provide such other information and assistance as Merck may reasonably request in connection with the completion of and submission of applications for Regulatory Approvals for Products and the maintenance thereof.

More Definitions of DMF

DMF means a Drug Master File for Captisol, as filed as of the Effective Date, or as hereafter updated from time to time during the Term, by CyDex with the FDA.

DMF means a Drug Master File maintained with a Regulatory Authority in any country within the Territory.

DMF means a Drug Master File filed with the FDA, EMA, MHLW or another foreign equivalent.

DMF means a Drug Master File as described in 21 C.F.R. § 314.420.

DMF means a version of the United States Social Security Administration’s Death Master File or any other database or service that is at least as comprehensive as the United States Social Security Administration’s Death Master File for determining that a person has reportedly died. The Death Master File must include at least one full version of the file and may include update files.

DMF means Drug Master File maintained with the FDA or its equivalent maintained with a Competent Authority in any other country mutually agreed between the Parties.

DMF means the drug master file relating to the Product, containing all the information on the validation activities, manufacture, and testing of the Product.