Marketing Studies definition

Marketing Studies means those clinical trials and studies (including, for the purposes of this Agreement, physician-held IND studies) which are performed essentially for marketing purposes and expressly excludes all clinical studies and trials which are required to pursue, obtain, and maintain Regulatory Approval in the Territories.
Marketing Studies mean human Clinical Trials of a Licensed Product conducted following Initiation of a Pivotal/Registrational Trial for such Licensed Product that are not required for receipt of Regulatory Approval (whether such human Clinical Trial is conducted prior to or after receipt of such Regulatory Approval) and is not a Post-Approval Study, but that may be useful in support of the post-Regulatory Approval exploitation of such Licensed Product.
Marketing Studies means those clinical trials and studies (including, for the purposes of this Agreement, physician-held IND studies) which are performed essentially for marketing purposes and expressly excludes all clinical studies

Examples of Marketing Studies in a sentence

  • The Parties shall use their reasonable efforts, working through the Clinical Development Committee, to coordinate Marketing Study strategies and the implementation of such strategies so as to maximize the benefit of Marketing Studies to the Product worldwide and to avoid duplication or conflict in such Marketing Studies.

  • 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.

  • Almirall shall have control of Marketing Studies conducted under the Commercialisation Plan and in such capacity shall be responsible for the payment of any compensation due to any participant in such trials who suffer death or bodily injury pursuant to any legal rights or applicable industry guidelines.

  • In such case, responsibilities for the conduct of such Post Marketing Studies for the Licensed Product and sharing of related costs shall be mutually agreed by the JSC.

  • The quantity of each such Purchase Order are to be agreed by the JSC, save that in no event shall such quantities to be used in Marketing Studies or given away as free samples be more than is common in the industry for this sort of Product.

  • The Parties shall resolve all disputes related to Proposals pursuant to the procedures described in Section 4.4. Each Party shall be permitted to conduct Post-Licensure Marketing Studies of a Product(s) on its own and at its sole expense, provided that progress reports on the status and clinical results (including, without limitation, Clinical Data pertaining to such Product(s)) of such Post-Licensure Marketing Studies shall be reported to the Joint Committee at their regularly scheduled meetings.

  • Final decisions with respect to Marketing Studies intended for use solely within the U.S. Territory shall be made by SuperGen.

  • The Parties shall also form a Product Development Committee which shall be responsible for developing worldwide strategies for Marketing Studies that build value for the Products and shall act in an advisory capacity with respect to (i) the clinical development and Product Approval of the Products in the Territories and (ii) potential combination therapies using the Products, the products to be co-promoted by the Parties under the Co-Promotion Agreement, and/or one or more other pharmaceutical products.

  • It shall generally follow the rules established by Section 4.2(a)(i) through (vi) for the U.S. Marketing Board, except that final decisions with respect to Marketing Studies shall be made by Triangle with respect to Marketing Studies proposed or requested by the U.S. Marketing Board and by ▇▇▇▇▇▇ with respect to Marketing Studies proposed or requested by the International Marketing Board, irrespective of the country or countries in which such Marketing Studies are conducted.

  • Licensee’s quality assurance department will be responsible for establishing audit plans for the Development activities assigned to Licensee with respect to any Shared Clinical Trial, and Post-Approval Marketing Studies according to Licensee’s internal SOP.


More Definitions of Marketing Studies

Marketing Studies means those clinical trials and studies (including, for the purposes of this Agreement, physician-held IND studies) which are
Marketing Studies means the marketing studies related to the ----------------- Business set forth on Schedule 1.1(b).
Marketing Studies means those clinical trials and studies (including,
Marketing Studies means those studies conducted after Product approval or clearance designed to enhance or further develop a market.

Related to Marketing Studies

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Commercialization or “Commercialize” means any and all activities undertaken at any time for a particular Licensed Product and that relate to the manufacturing, marketing, promoting, distributing, importing or exporting for sale, offering for sale, and selling of the Licensed Product, and interacting with Regulatory Authorities regarding the foregoing.

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.