Approved Labeling definition

Approved Labeling means, with respect to a Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.

Approved Labeling means the Food and Drug Administration’s (FDA) approved labeling which contains FDA approved information for the diluent, the resultant strength, the container closure system, and storage time.

Approved Labeling means, with respect to each Licensed Product: (a) the Regulatory Authority-approved full prescribing information for such Licensed Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Licensed Product.

Examples of Approved Labeling in a sentence

• Each Party shall promptly notify the other Party’s Regulatory Affairs Department contacts designated in writing by the other Party of any information that such Party receives regarding any threatened or pending action by any Regulatory Authority that may affect the proposed labeling or Approved Labeling for a Product or Infusion set in the Field in the U.S. or any Major Market or the continued Commercialization of a Product or Infusion set in the U.S. or any Major Market.

• Each Party will perform, or will ensure that each of its Affiliates, Sublicensees, and Subcontractors perform, all Commercialization activities in the Territory for which it is responsible pursuant to this Agreement in a professional and ethical business manner and in compliance with Applicable Law, Professional Requirements, the Approved Labeling, and the Commercialization Plan.

• In accordance with Section 6.8.2 (Branding), ALJ will be responsible for the development of all Packaging and Labeling for the Products for each country of the Territory (which will be based on Evelo’s global branding strategy), and the Responsible Party for each country in the Territory will be responsible for filing for approval for the Approved Labeling and all other Packaging and Labeling for each Product in each country in the Territory.

• Leave without pay may be granted by the Select Board under special circumstances.

• The JDC will review any changes in regulatory strategy and, to the extent requested by Kiniksa, will discuss any Regulatory Submission for which Partner is responsible and all proposed Approved Labeling for the Licensed Product in each Key Country and, to the extent requested by Kiniksa for each other country or region in the Territory.

More Definitions of Approved Labeling

Approved Labeling means the Food and Drug Administration’s (FDA) approved labeling in accordance with sections 201.56 and 201.57 of title 21, Code of Federal Regulations that contains FDA approved information for the diluent, the resultant strength, the container closure system, and storage time.

Approved Labeling means, with respect to a Collaboration Product: (a) the Regulatory Authority-approved full prescribing information for such Collaboration Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Collaboration Product.

Approved Labeling means the approved labeling for Product or Infusion set as set forth in the applicable Regulatory Approval in a particular jurisdiction.

Approved Labeling means, with respect to a Cost Profit Sharing Product: (a) the Regulatory Authority-approved full prescribing information for such Cost Profit Sharing Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such Cost Profit Sharing Product.

Approved Labeling has the meaning set forth in Section 1.7(a) hereof.

Approved Labeling means, with respect to a DT Co-Co Product: (a) the Regulatory Authority-approved full prescribing information for such DT Co-Co Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such DT Co-Co Product.

Approved Labeling means, with respect to a SYNGAP1 Co-Co Product: (a) the Regulatory Authority- approved full prescribing information for such SYNGAP1 Co-Co Product; and (b) the Regulatory Authority-approved labels and other written, printed, or graphic materials on any container, wrapper, or any package insert that is used with or for such SYNGAP1 Co-Co Product.