Division 2 of Part C of the Food and Drug Regulations (Canada); and
together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;
“Components” means, collectively, all packaging components, starting materials, excipients, ingredients, and other materials required to manufacture the Bulk Drug Products in accordance with the Specifications, other than the Active Pharmaceutical Ingredients.
Parts 210 and 211 of Title 21 of the United States' Code of Federal Regulations; and
“Client Intellectual Property” means Intellectual Property generated or derived by or on behalf of Client, or by or on behalf of [[Organization A:Organization]] while performing any Manufacturing Services or otherwise generated or derived by [[Organization A:Organization]] in its business, which ;
“FD&C Act” means the United States Federal Food, Drug, and Cosmetic Act, as amended, and the rules and regulations promulgated thereunder.
“IND” means # an Investigational New Drug Application as defined in the United States Federal Food, Drug and Cosmetic Act, as amended (and any successor regulation) (the “FD&C Act”) and applicable regulations promulgated thereunder by the FDA, or # an equivalent application or other authority pursuant to the laws and regulations of equivalent Regulatory Authority in any other regulatory jurisdiction, which is necessary to initiate or conduct Clinical Trials of a pharmaceutical or biological product in humans in such jurisdiction.
“IND/CTA” means # any Investigational New Drug Application, as defined in the United States Federal Food, Drug and Cosmetics Act, as amended from time to time, and the regulations promulgated thereunder, filed with the FDA pursuant to Part [[Identifier]] of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto (an “IND”); and # any comparable filing(s) outside the United States (such as a CTA in the European Union) necessary to commence Clinical Trials, including any amendments thereto (a “CTA”).
“Act”. Act means both the United States Federal Food, Drug, and Cosmetic Act, as amended from time to time, and the regulations promulgated under the foregoing.
“NDA” means a New Drug Application, as defined in the US Federal Food, Drug and Cosmetic Act, as amended, and applicable regulations promulgated thereunder by the FDA, and the equivalent application to the equivalent Regulatory Authority in any other regulatory jurisdiction.
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