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 commenced after NDA filing but before NDA Approval.

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.

• ORTHO shall be the LDP in the Profit/Loss Sharing Territory for any and all: (a) Clinical Trials for the Obesity Indication for Bromocriptine commencing with the start of Phase IIB Clinical Trials; (b) Clinical Trials for all other Collaboration Products commencing with Phase IIB Clinical Trials; and (c) Phase IIIB Clinical Trials not recited in Exhibit E and Phase IV Clinical Trials for Bromocriptine and other Collaboration Compounds approved for sale in the Profit/Loss Sharing Territory.

• 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.

• ORTHO shall make all final decisions with respect to Commercialization Plans and Commercialization Budgets (except for the costs of the Phase IIIB Clinical Trials described in Exhibit E).

• 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.

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

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.

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 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, 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