Product Labeling definition

Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority-approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

Product Labeling means (a) the full prescribing information for a Supplied Product approved by the applicable Regulatory Authority in the Horizon Territory, and (b) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for a Supplied Product in the Horizon Territory.

Product Labeling means (a) the full prescribing information for the Product approved by the applicable Regulatory Authority, and (b) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for the Product.

Examples of Product Labeling in a sentence

• In exercising its rights pursuant to this ARTICLE 4, Licensee shall seek to prevent claims or representations in respect of the Licensed Products or the characteristics of the Licensed Products (e.g., safety or efficacy) being made by or on behalf of it or its Affiliates, Sublicensees or Distributors (by members of its or their sales force or otherwise) that do not represent an accurate or fairly balanced summary or explanation of the Product Labeling for the Licensed Products in the country in question.

• Amarin’s responsibilities shall specifically include all communications with the FDA related to the Product and Amarin shall have sole responsibility to seek and/or obtain any necessary approvals of the Product Labeling used in connection with the Product in the Territory, and for determining whether the same requires approval.

• Kowa represents and warrants that it and the Kowa Sales Representatives have a secure and proper environment for storage of Samples in accordance with the Product Labeling.

• Exhibit 2.2 Product Labeling Written Product labeling instructions to be provided by Codexis India to Arch.

• When packaged, all samples of the Products distributed by Quinnova will bear the Oculus Trademarks and the Product Labeling (if required) and no other marks or labels unless expressly agreed upon in writing by Oculus.

More Definitions of Product Labeling

Product Labeling shall have the same meaning as defined in the Act and as interpreted by the Regulatory Authority in each country in the Territory.

Product Labeling means all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article.

Product Labeling has the same meaning as defined in the Act and as interpreted by the FDA, and any analogous Laws as interpreted by an applicable Regulatory Authority elsewhere in the Territory.

Product Labeling means, with respect to a Licensed Product in a country or other jurisdiction in the Territory, (a) the Regulatory Authority‑approved full prescribing information for such Licensed Product for such country or other jurisdiction, including any required patient information, and (b) all labels and other written, printed, or graphic matter upon a container, wrapper, or any package insert utilized with or for such Licensed Product in such country or other jurisdiction.

Product Labeling means (i) the FDA approved full prescribing information for the Product, including any required patient information, and (ii) all labels and other written, printed, or graphic matter upon any container, wrapper, or any package insert, utilized with or for the Product.

Product Labeling means the labels and other written, printed or graphic matter upon (a) any container or wrapper utilized with the Product or (b) any written material accompanying the Product, including Product package inserts, in each case as approved by the FDA.

Product Labeling means (i) the full prescribing information for any Product, as approved by the relevant Regulatory Authority and (ii) all labels and other written, printed or graphic information included in or placed upon any container, wrapper or package insert used with or for any Product that complies with the Regulatory Approval for such product.