EXPLOITATION OF PRODUCTS. 33 12.A Regulatory Approvals....................................................34
EXPLOITATION OF PRODUCTS. 12.1. Nascime shall diligently pursue the research, development, prosecution and commercialization of the Products, as provided in the Business Plan. In order to commercialize the Products, Nascime shall use commercially reasonable efforts to obtain, or have obtained for Nascime, marketing approval in such countries in the Territory as is determined by the Business Plan. It may be necessary to file an NDA and perform clinical testing in more than one country. The strategy for the registration and the commercialisation of the Products shall be determined by the Nascime Directors.
EXPLOITATION OF PRODUCTS. 9.1 The Company will have [****] and in any Products subject to the **** REPRESENTS MATERIAL REACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
EXPLOITATION OF PRODUCTS. 11.1. The Company will have an exclusive entitlement to develop and/or exploit Products in the Field. In order to commercialize the Products the Company shall obtain marketing approval in such countries in the Territory as is determined by the Business Plan. It may be necessary to file an INDA and perform clinical testing in more than one country, and the Shareholders shall reasonably agree on such testing.
EXPLOITATION OF PRODUCTS. Xxxxxx agrees and acknowledges that [***]. Seller acknowledges and agrees that (a) [***], (b) [***], and (c) the parties solely intend the express provisions of this Agreement (and, for the avoidance of doubt, not the Existing Agreements) to govern their contractual relationship with respect to the Purchased Assets and the Products. [***].
EXPLOITATION OF PRODUCTS. If MBC has not commenced the Exploitation of a Product in a country in which a valid enforceable and unexpired patent application(s), patent(s) or patent extension(s) covering the Product exists within the Territory within five (5) years of the Commencement Date, then PGL may by written notice, advise MBC that unless it commences Exploitation of a Product in that country within 6 months (or such longer period set out in the notice), that country will be removed from the definition of Territory in this agreement. A notice may include more than one country and will be taken to be a notice in respect of each country specified in the notice. Should Exploitation not occur during that 6 month or longer stipulated period, the country will be removed from the Territory.
EXPLOITATION OF PRODUCTS. If GTB has not commenced the Exploitation of a Product in a country in which a valid enforceable and unexpired patent application(s), patent(s) or patent extension(s) covering the Product exists within the Territory within five (5) years of the Commencement Date, then PharmaSynth may by written notice, advise GTB that unless it commences Exploitation of a Product in that country within 6 months (or such longer period set out in the notice), that country will be removed from the definition of Territory in this agreement. A notice may include more than one country and will be taken to be a notice in respect of each country specified in the notice. Should Exploitation not occur during that 6 month or longer stipulated period, the country will be removed from the Territory.
EXPLOITATION OF PRODUCTS. 9.1 The Company will have [****] any Elan Royalty Products subject to the other terms of this Agreement. [****]. It may be necessary to file a Regulatory Application and perform clinical testing in more than one country. The conduct of such clinical trials and the obtaining of Regulatory Approvals shall be regulated in accordance with arrangements agreed upon by the Management Committee. _____________ [****] REPRESENTS MATERIAL WHICH HAS BEEN REDACTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
