Phase IV Studies definition

Phase IV Studies means a study for a Collaboration Product that ---------------- is initiated in a Country after receipt of a Marketing Authorization for a Collaboration Product in the United States and which is expected to be completed with respect to an Adolor Product during the Adolor Product Promotion Term and with respect to a GI Product during the GI Product Promotion Term and is principally intended to support the marketing and Commercialization of such Collaboration Product in the United States, including without limitation investigator initiated trials, clinical experience trials and studies conducted to fulfill local commitments made as a condition of any Marketing Authorization.

Phase IV Studies means a study for a Collaboration Product that is initiated after receipt of a Marketing Authorization for a Collaboration Product and is principally intended to support the marketing and Commercialization of such Collaboration Product, including without limitation investigator initiated trials, clinical experience trials and studies conducted to fulfill local commitments made as a condition of any Marketing Authorization.

Phase IV Studies means clinical studies designed to enhance sales for an approved indication, but shall not include Pharmacoeconomic Studies.

Examples of Phase IV Studies in a sentence

• Wyeth-Ayerst shall have the right to review and comment on, but not the right to approve, any protocols for Phase IV Studies prior to commencement of such Phase IV Studies.

• Upon NDA Assignment, Collegium shall, at its sole cost and expense, be responsible for all post-Governmental Approval reporting of ADEs and surveillance of Phase IV Studies in the Territory, if and as required by Competent Authorities.

• BDSI will have the right to review and comment, and have such comments reasonably considered by Collegium, reasonably in advance with regard to all Development-, manufacturing-, and formulation-related activities (including Phase IV Studies) proposed to be conducted by or on behalf of Collegium in regards to any Licensed Product.

• With regard to Grünenthal Territory other than the EU, the Parties shall obtain the data and know-how of Xxxxx XXXX, Xxxxx XXXX0 and Phase IV Studies and Post Approval Commitments free of charge.

• Phase IV Studies may include clinical trials, or other tests and studies, conducted in support of pricing/reimbursement for the first Approval of the Licensed Product, epidemiological studies, modeling and pharmacoeconomic studies, post-marketing surveillance studies, investigator sponsored clinical trials of a Licensed Product, and health economics studies.

More Definitions of Phase IV Studies

Phase IV Studies means clinical or other studies of any Agent which are undertaken following approval of the applicable NDA, and which are not required to be conducted as a condition of the FDA approval of the applicable NDA.

Phase IV Studies means any clinical study the results of which are intended to be used to support an expanded label claim for a Licensed Product in the Territory (even if such expanded label claims are marketed in the Territory under a different Marketing Authorization or trademark) such as new indications or formulations, or otherwise support marketing of a Licensed Product in the Territory.

Phase IV Studies means a study or data collection effort for the Product that is initiated in the Territory after receipt of Regulatory Approval for the Licensed Product.

Phase IV Studies means those studies, including safety ---------------- surveillance studies, conducted under an Immunex IND which are agreed upon by Immunex and either the FDA or HPB, as applicable, as a condition of approval or maintenance of approval of an Immunex BLA or NDS for Enbrel, as the case may be, other than (a) Marketing Clinical Studies, (b) patient registries included within the definition of Marketing Expenses, and (c) those studies for a New Indication the cost of which are New Indication Expenses.

Phase IV Studies means any post-Regulatory Approval after-market studies required to be performed by any Regulatory Authority in connection with the commercialization of the Licensed Product.

Phase IV Studies means both post-marketing and pharmacoeconomic studies that are initiated by NBIX after Approval and are not requested, mandated or required by an Agency to support or maintain an Approval. Phase IV Studies does not include investigator initiated studies or Post-Approval Commitment Studies in the Territory.

Phase IV Studies means clinical studies performed after obtaining Marketing Authorization for the purpose of supporting the marketing and Commercialization of the Product. For the avoidance of any doubt, “Phase IV Studies” does not include the RRS (as hereinafter defined).