Phase IIIB Clinical Trials definition

Phase IIIB Clinical Trials means product support clinical trials of a Licensed Product (i.e., a clinical trial which is not required for receipt of Regulatory Approval but which may be useful in providing additional drug profile data) commenced before receipt of Regulatory Approval in the country where such trial is being conducted.

Phase IIIB Clinical Trials means one (1) or more product support clinical trial(s) with respect to a pharmaceutical product (i.e., a clinical trial which is not required for receipt of initial regulatory approval for a product but which may be useful in providing additional drug profile data or in seeking a label expansion) commenced before receipt of regulatory approval for the indication for which such trial is being conducted. ** CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND WILL BE FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A CONFIDENTIAL TREATMENT REQUEST.

Phase IIIB Clinical Trials means product support clinical trials of a Collaboration Product, which is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or expansion of the Collaboration Product's label claim, and which is

Examples of Phase IIIB Clinical Trials in a sentence

• In addition, as part of an approved Commercialization Budget and/or an approved Launch Budget, the JDC will provide such support with respect to Phase IIIB Clinical Trials and Phase IV Clinical Trials as may be reasonably requested by the JCC.

• In addition, the JPT will oversee and provide such support with respect to Phase IIIB Clinical Trials and Phase IV Clinical Trials as may be reasonably be requested by ORTHO.

• Notwithstanding any other provision of this Agreement, ERGO shall be the LDP with respect to the Phase IIIB Clinical Trials for Bromocriptine as specifically described in Exhibit E; provided, however, that ERGO shall develop and finalize the protocols for such trials only after review by and concurrence of ORTHO.

• In addition, in connection with an approved Commercialization Budget and/or an approved Launch Budget, the JDC will oversee Phase IIIB Clinical Trials, and shall provide such support with respect to Phase IV Clinical Trials as may be reasonably requested by the JCC.

• The JDC will also facilitate the flow of information with respect to development activities being conducted for Licensed Product, oversee registrational clinical trials and, where necessary, collaborate with the JCC to oversee any Phase IIIB Clinical Trials.

More Definitions of Phase IIIB Clinical Trials

Phase IIIB Clinical Trials means product support clinical trials of a Licensed Product, which is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or expansion of the Licensed Product’s label claim. Phase IIIB Clinical Trials shall include GTx’s one year extension trial of an 80 mg dose of Initial Products for the ADT Indication.

Phase IIIB Clinical Trials means product support clinical trials of a Product (I.E., a clinical trial that is not required for receipt of Regulatory Approval but that may be useful in providing additional drug profile data) commenced before receipt of Regulatory Approval in the country where such trial is being conducted.

Phase IIIB Clinical Trials means product support clinical trials of a Licensed Product (i.e., a clinical trial which is not required for receipt of Regulatory Approval but which may be useful in providing additional drug profile data) commenced before receipt of Regulatory Approval. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.

Phase IIIB Clinical Trials means product support clinical trials of a Collaboration Product (i.e., a clinical trial which the JDC determines is not required for receipt of Regulatory Approval but which may be useful in providing additional drug profile data) commenced before receipt of Regulatory Approval in the country where such trial is being conducted.

Phase IIIB Clinical Trials means product support clinical trials of a Licensed Product (i.e., a clinical trial which is not required for receipt of

Phase IIIB Clinical Trials means product support clinical trials of a Collaboration Product, which is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or expansion of the Collaboration Product's label claim, and which is commenced after NDA filing but before NDA Approval.

Phase IIIB Clinical Trials means product support clinical trials of a ---------------------------- Collaboration Product in the Profit/Loss Sharing Territory (i.e., a clinical trial which the JPT determines is not required for receipt of initial Regulatory Approval but which may be useful in providing additional drug profile data or expansion of the Collaboration Product's Label Claim) commenced after NDA filing but before NDA approval. These trials shall be considered a part of Commercialization Activities, except for the clinical trials for Bromocriptine specifically identified in Exhibit E, which trials shall be considered Development Activities for the purposes of this Agreement; provided, however, that the clinical trials for Bromocriptine identified in Exhibit E shall in any event be designated Phase IIIB Clinical Trials.