Research Plan The Parties recognize that the Research Plan describes the collaborative research and development activities they will undertake and that interim research goals set forth in the Research Plan are good faith guidelines. Should events occur that require modification of these goals, then by mutual agreement the Parties can modify them through an amendment, according to Paragraph 13.6.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company or any of its subsidiaries, that are described in the Registration Statement and the Prospectus, as applicable, and are intended to be or have been submitted to FDA or other comparable governmental entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, applicable Authorizations, and Applicable Laws, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder and, for studies submitted to regulatory authorities for approval, in all material respects, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement and the Prospectus are, to the Company’s knowledge, accurate and complete and fairly present the data derived from such studies and trials in all material respects; except to the extent disclosed in the Registration Statement and the Prospectus, the Company and each of its subsidiaries, is not aware of any studies or trials, the results of which the Company believes materially call into question the study or trial results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement or the Prospectus, the Company or any of its subsidiaries have not received any written notices or correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company or any of its subsidiaries, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Development Plan document specifying the work program, schedule, and relevant investments required for the Development and the Production of a Discovery or set of Discoveries of Oil and Gas in the Contract Area, including its abandonment.