Examples of Clinical Supply Requirements in a sentence

All Clinical Supply Requirements (beyond those listed in Section 3.1.2) will be Alimera’s sole responsibility.
Such Finished Product for Clinical Supply Requirements Manufactured on behalf of Regeneron will be billed to Sanofi at the Manufacturing Cost as a Development Cost, in accordance with Part I of Schedule 1.
To the extent that Regeneron maintains manufacturing capacity available for the Manufacture of Clinical Supply Requirements, the cost of maintaining such capacity shall be included as a Development Cost to the extent it is not included as a Manufacturing Cost.
If an entity other than Regeneron is to be used to Manufacture Formulated Bulk Product for Clinical Supply Requirements, preference shall be given to Sanofi or an Affiliate of Sanofi that is qualified to Manufacture the applicable Licensed Product in accordance with applicable Good Practices and where the estimated Manufacturing Cost is comparable to that of Third Party Manufacturers.
The Formulated Bulk Product Manufactured by or on behalf of Regeneron for Clinical Supply Requirements will be billed to Sanofi by Regeneron at the Manufacturing Cost per Part I of Schedule 1 as a Development Cost.

More Definitions of Clinical Supply Requirements

Clinical Supply Requirements means, with respect to a Co-Funding Product, (a) the quantities of such Co-Funding Product (or placebo or comparator agent, as the case may be) required by a Party or the Parties for Development in the Field under this Agreement in connection with the Global Development Plan and (b) quantities of the Co-Funding Product that are required by a Party for submission to a Regulatory Authority, including in connection with any Registration Filing or Approval in the Field in any regulatory jurisdiction in the world or in connection with any request by such Regulatory Authority.

Clinical Supply Requirements means, with respect to a VEGF Product, the quantities of such VEGF Product which are required by a Party or the Parties (i) for Development, including the conduct of pre-clinical studies and Clinical Trials in connection with a Co-Development Plan in order to obtain Approval of such VEGF Product in any country in the Territory and quantities of such VEGF Product which are required by a Party for submission to a Regulatory Authority in connection with any Registration Filing or Approval in any country in the Territory or (ii) for any Non-Approval Trial.

Clinical Supply Requirements means, with respect to the Product and placebo, the quantities of such Product and placebo ordered by Kiniksa for Development purposes under the Clinical Supply Agreement.

Clinical Supply Requirements means the quantities of the Product which are required by a Party or the Parties for the Development of a Product under this Agreement, including, without limitation, the conduct of pre-clinical studies and clinical trials in connection with each Annual Development Plan. “Commercialize” means to promote, market, distribute, sell (and offer for sale or contract to sell) or provide product support for a Product, including by way of example: (a) detailing and other promotional activities in support of a Product; (b) advertising and public relations in support of a Product, including market research, development and distribution of selling, advertising and promotional materials, field literature, direct-to-consumer advertising campaigns, media/journal advertising, and exhibiting at seminars and conventions; (c) developing reimbursement programs and information and data specifically intended for national accounts, managed care organizations, governmental agencies (e.g., federal, state and local), and other group purchasing organizations, including pull-through activities; (d) other co-promotion activities not included in the above; (e) conducting medical education activities and journal advertising; and (f) [ * ]. For clarity, “Commercializing” and “Commercialization” have a correlative meaning.

Clinical Supply Requirements means the quantities of the Product which are required by a Party or the Parties for the Development of a Product under this Agreement, including, without limitation, the conduct of pre-clinical studies and clinical trials in connection with each Annual Development Plan. “Commercialize” means to promote, market, distribute, sell (and offer for sale or contract to sell) or provide product support for a Product, including by way of example: (a) detailing and other promotional activities in support of a Product; (b) advertising and public relations in support of a Product, including market research, development and distribution of selling, advertising and promotional materials, field literature, direct-to-consumer advertising campaigns, media/journal advertising, and exhibiting at seminars and conventions; (c) developing reimbursement programs and information and data specifically intended for national accounts, managed care organizations, governmental agencies (e.g., federal, state and local), and other group purchasing organizations, including pull-through activities; (d) other co-promotion activities not included in the above; (e) conducting medical education activities and journal advertising; and (f) conducting [ * ] or [ * ]. For clarity, “Commercializing” and “Commercialization” have a correlative meaning.

Clinical Supply Requirements means, with respect to a Licensed Product, the quantities of Finished Product, comparator agent and/or placebo as are required by a Party or the Parties for Development in the Field under this Agreement, including, without limitation, the conduct of research, pre-clinical studies and clinical trials in connection with a Development Plan, and quantities of such Licensed Product that are required by a Party for submission to a Regulatory Authority in connection with any Registration Filing or Approval in the Field in any regulatory jurisdiction in the Territory.