Post-Approval Marketing Studies definition

Post-Approval Marketing Studies means a human clinical trial or other test or study with respect to the Product for use in the Field, which test or study is conducted on a voluntary basis by a Party (rather than under a mandate from a Regulatory Authority in order to obtain or maintain Regulatory Approval for the Product in the Field) after the Drug Approval Application for the Product in the Field in the Territory has been approved by the Regulatory Authority in the Territory. Any human clinical study that is intended to expand the label for the Product for use in the Field in the Territory shall be a Clinical Study. Subject to the foregoing, Post-Approval Marketing Studies may include clinical studies conducted in support of pricing or reimbursement for the Product in the Field in the Territory, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing studies, investigator sponsored studies, and health economic studies.
Post-Approval Marketing Studies means a human clinical trial or other test or study with respect to the Product for use in the Field in the Territory, which test or study is conducted on a voluntary basis by a Party (rather than under a mandate from a Regulatory Authority in the applicable country in the Territory in order to obtain or maintain Regulatory Approval for the Licensed Product in the Field in such country in the Territory) after the MAA for the Licensed Product in the Field in such country in the Territory has been approved by the Regulatory Authority in such country in the Territory. Any human clinical study that is intended to expand the label for the Licensed Product for use in the Field in such country in the Territory shall be a Clinical Study. Subject to the foregoing, Post-Approval Marketing Studies may include clinical studies conducted in support of pricing or reimbursement for the Licensed Product in the Field in such country in the Territory, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing studies, investigator sponsored studies, and health economic studies.
Post-Approval Marketing Studies means a human clinical trial or other test or study with respect to the Product for use in the Field in the Territory, which test or study is conducted on a voluntary basis by a Party (rather than under a mandate from a Regulatory Authority in the Territory in order to obtain or maintain Regulatory Approval for the Product in the Field in the Territory) after the Drug Approval Application for the Product in the Field in the Territory has been approved by the Regulatory Authority in the Territory. Any human clinical study that is intended to expand the label for the Product for use in the Field in the Territory shall be a Clinical Study. Subject to the foregoing, Post-Approval Marketing Studies may include clinical studies conducted in support of pricing or reimbursement for the Product in the Field in the Territory, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing studies, investigator sponsored studies, and health economic studies.

Examples of Post-Approval Marketing Studies in a sentence

  • The Parties, through the JDC, shall develop policies and procedures (the “Publication Policies”) for any publication with respect to the results of Clinical Studies and Post-Approval Marketing Studies for a Product in the Field in the Territory, including disclosure applicable to clinical trial registries, which policies and procedures shall be consistent with the Parties’ respective policies and procedures for publication and disclosure of the results of human clinical trials consistently applied.

  • Upon completion of the Transition Plan and subject to Article 4.6(a) with respect to Ongoing Clinical Studies and Post-Approval Marketing Studies to be sponsored by Licensor in accordance with Article 4.1(b), Licensee or its Affiliates (or if required by applicable Law, its Sublicensees) shall own all regulatory submissions, including all applications, for Marketing Approvals for the Product in the Field in the Licensee Territory.

  • For the avoidance of doubt, any Clinical Studies other than Post-Approval Marketing Studies and Phase IV Studies performed by Takeda shall be included in the Development Plan.

  • After Regulatory Approval, the Parties shall meet to discuss in good faith the cost of Product for Post-Approval Marketing Studies.

  • All abstracts, manuscripts and presentations (including information to be presented verbally) that disclose results of Clinical Studies or Post-Approval Marketing Studies for a Product shall be reviewed and approved by the JDC in accordance with the Publication Policies.

  • With respect to any Ongoing Clinical Studies or Post-Approval Marketing Studies to be performed in accordance with Article 4.1(b), the Parties and their Affiliates shall cooperate fully so that the Party which is the sponsor of such Ongoing Clinical Study or Post-Approval Marketing Study, as applicable, in the Licensee Territory, may make the necessary and appropriate Regulatory Filings and submissions and undertaking such regulatory interactions.

  • Each Party also shall have the right to require that any of its Confidential Information (but not the results of the Clinical Studies or Post-Approval Marketing Studies for a Licensed Product in the Field in the applicable country in the Territory that have been approved for disclosure pursuant to the Publication Policies) that is disclosed in any such proposed publication or presentation be deleted prior to such publication or presentation.

  • For the avoidance of doubt, any Post-Approval Marketing Studies and Phase IV Studies shall be included in the Commercialization Plan.

  • At each meeting of the JSC, each Party will report on its Development activities of the Product in the Field that such Party and its Affiliates has performed or caused to be performed since the last meeting of the JSC, and evaluate the work performed with respect to any Ongoing Clinical Studies, and Post-Approval Marketing Studies, and provide such other information as may be reasonably requested by the JSC with respect to such Development activities.

  • Xxxxxx shall fund, conduct and direct any Post-Approval Marketing Studies determined by the JCC provided that such Post-Approval Marketing Studies shall not negatively impact: (a) Sucampo’s marketing of the Product outside of the Territory or (b) Sucampo’s marketing of the Product for Other Indications in the Territory.

Related to Post-Approval Marketing Studies

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Development approval means any written authorization from a

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

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

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • 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.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • 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.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

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

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).