Post-Marketing Studies definition

Post-Marketing Studies means all non-interventional and interventional clinical trials of the Licensed Product with the main objective to collect data to increase product knowledge or for marketing and market access purposes, e.g., pricing studies, post-marketing surveillance studies, patient outcome studies, patient preference studies and investigator-initiated trials.

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Post-Marketing Studies means all interventional studies of Licensed Product with the main objective to collect data to increase product knowledge or for marketing and market access purposes (e.g. post-marketing surveillance studies, patient outcome studies, patient preference studies) other than Non-Interventional Studies and Post Approval Commitments.

Post-Marketing Studies means any clinical trial using Aldurazyme performed by Genzyme or its Affiliates required by regulatory authorities as a condition to the issuance, continuation, or maintenance of a Marketing Application Approval. Post-Marketing Studies shall not include registries.

Examples of Post-Marketing Studies in a sentence

With respect to any Post Marketing Studies required by a jurisdiction where Aldurazyme does not have Regulatory Approval as of the Effective Date, Genzyme shall, at its sole expense and in its sole discretion, have the responsibility for conducting any such Post-Marketing Studies that are not funded by BioMarin/Genzyme LLC pursuant to the terms of the Amended and Restated Collaboration Agreement.
In addition, the Parties may, from time to time, agree to include certain voluntary Post-Marketing Studies under the Development Plan; provided, however, that unless so included, neither Party shall conduct any such study independently in the Shared Territory.
In the event that the scope of the registry program is expanded to implement any Post-Marketing Studies required by regulatory authorities to be conducted through or as part of the registry program, such costs above the general cost of maintaining the registry program as currently conducted will be funded by BioMarin/Genzyme LLC pursuant to the terms of the Amended and Restated Collaboration Agreement.
Except as required by applicable Law, each Party agrees that it shall not publish or present the results of Development work or Post-Marketing Studies in the Shared Territory that are directed to any Collaboration Compound or Collaboration Product in the Field, including pre-clinical studies or clinical trials carried out as part of the Development Plan under this Agreement, without the prior approval of the applicable Committee, as set forth in Section 2.2.1(p).
Each Party shall keep complete and accurate scientific records relating to the Joint Post-Marketing Studies and will make such records reasonably available to the other Party for review and/or copying.
Catalyst shall be solely responsible, at its sole cost, for the Development of Licensed Products in the Field in the Territory; provided that BioMarin shall be responsible for fifty percent (50%) of the Joint Post-Marketing Studies as described in Section 3.5.
Egalet will bear its own internal expenses and the Parties shall share out-of-pocket expenses for the Required Post-Marketing Studies based on the Expense Split Percentage.
The Parties agree that to the extent such EU post-marketing studies are necessary or useful as post-marketing studies for the Territory, then Catalyst shall notify BioMarin and those studies shall be deemed Joint Post-Marketing Studies hereunder.
BioMarin will be responsible for conducting the Joint Post-Marketing Studies listed in Schedule 3.5 and, unless otherwise agreed in a Study Plan, BioMarin will be responsible for conducting any other Joint Post-Marketing Studies.
Each Party shall also keep detailed records of costs it incurs in connection with the Required Post-Marketing Studies, including all supporting documentation for such expenses, and will keep such records for at least three (3) years after the date that such expense was incurred.

More Definitions of Post-Marketing Studies

Post-Marketing Studies means clinical trials or other studies initiated after receipt of Regulatory Approval in the country for which such trials or studies are being conducted, including epidemiological studies, modelling and pharmaco-economic studies, investigator-initiated clinical trials, and observational studies, but excluding any Mandatory Post-Approval Studies.

Post-Marketing Studies means any clinical trials or studies conducted with a Licensed Product after receipt of Regulatory Approval of the Licensed Product, which are conducted voluntarily in order to enhance marketing or scientific knowledge of the Licensed Product and are not required by Regulatory Authorities or are not intended to support Regulatory Approval of a Licensed Product for a new indication or other material change to the Product Label and Insert.

Post-Marketing Studies shall have the meaning set forth in Section 4.1(c)(iii).

Post-Marketing Studies means any REMS programs and/or non-Phase IV Commitment studies conducted after the receipt of Marketing Approval for the Product in the U.S. but that are not conducted to fulfill commitments made to the FDA as a condition for the receipt of such Marketing Approval.

Post-Marketing Studies means any Clinical Trial conducted with a Licensed Product after receipt of Regulatory Approval of the Licensed Product, which are conducted voluntarily in order to enhance marketing or scientific knowledge of the Licensed Product and are not required by Regulatory Authorities or are not intended to support Regulatory Approval of a Licensed Product for a new indication or other material change to the product label. 1.160 “Pre-Existing Acquired Rights from Third Parties” means any and all agreements by and between Arrowhead and any Third Party, in effect as of the Original Execution Date, and pursuant to which the Third Party assigns (by express terms, whether or not using the word “assign”) Arrowhead any Third Party’s Patent Rights or Know-How that, in whole or in part, are necessary or useful for Developing, Manufacturing, or Commercializing any Licensed Product. As of the Amended Effective Date, the Pre-Existing Acquired Rights from Third Parties are set forth on Part III of Schedule 1.163. 1.161 “Pre-Existing Licenses from Third Parties” means any and all agreements by and between Arrowhead and any Third Party, in effect as of the Original Execution Date, and pursuant to which the Third Party grants (by express terms, whether or not using the word “license”) Arrowhead any license or sublicense (or use or other Exploitation) rights to or under any Third Party’s Patent Rights or Know-How that, in whole or in part, are necessary or useful for Developing, Manufacturing, or Commercializing any Licensed Product. As of the Amended Effective Date, the Pre-Existing Licenses from Third Parties are set forth on Part I of Schedule 1.163. 1.162 “Pre-Existing Licenses to Third Parties” means any and all agreements by and between Arrowhead and any Third Party, in effect as of the Original Execution Date, and pursuant