FDA Trials Sample Clauses

FDA Trials. Except as set forth in the Registration Statement and the Prospectus, there is no legal or governmental proceeding to which the Company or any of its Subsidiaries is a party or of which any property or assets of the Company or any of its Subsidiaries is the subject, including any proceeding before the United States Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) or comparable federal, state, local or foreign governmental bodies (it being understood that the interactions between the Company and the FDA and such comparable governmental bodies relating to the testing, clinical development, manufacture and product approval process for its products shall not be deemed proceedings for purposes of this representation), which is required to be described in the Registration Statement or the Prospectus or a document incorporated by reference therein and is not described therein, or which, singularly or in the aggregate, if determined adversely to the Company or any of its Subsidiaries, could reasonably be expected to result in a Material Adverse Change; and to the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities. The Company is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business as currently conducted, except where noncompliance would not, singularly or in the aggregate, result in a Material Adverse Change. All preclinical and clinical studies conducted by or on behalf of the Company and submitted to regulatory authorities to support approval for commercialization of the Company’s products have been conducted by the Company, or to the Company’s knowledge by third parties, in compliance with all applicable federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance as could not reasonably be expected to result in, singly or in the aggregate, a Material Adverse Change.
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FDA Trials. The Company is currently in compliance with the FDA protocols (as modified from time to time) for Phase II clinical trials with respect to its PresVIEW Scleral Implant and PresVIEW Incision System (G970152) for the treatment of presbyopia (hereinafter referred to collectively as the “Procedure”). The Company has not received a notice from the FDA that has not been resolved to permit the continuation of its current clinical trials, and the Company reasonably believes, as of the date hereof based on the advice of its outside FDA expert, that the FDA is likely to issue its approval to initiate Phase III of the clinical trial and to issue its final approval of the Procedure, in each case, in due course.
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FDA Trials. (a) The Purchaser shall use its commercially reasonable best efforts to commence patient recruitment to advance the CDP of Teverelix within 12 months following the Closing Date. Such efforts specifically include, but are not limited to, capital formation (including by raising capital for this purpose through an issuance of further shares of the Purchaser) to support the CDP for preventing recurrence of AUR and treatment of advanced prostate cancer in patients with high cardiovascular risk. (b) In the event that the Purchaser fails to commence an FDA Phase 2 trial (defined as First Patient In the trial dosed) on either the advanced prostate cancer or AUR indication within 12 months following the Closing Date, as additional consideration, the Antev Vendors shall in aggregate receive $1.5 million (inclusive of VAT (if applicable)) for each indication so delayed (the "Delay Fees"), which shall be paid to the Antev Vendors in accordance with their respective pro rata interest in the Consideration Shares issued to such Antev Vendor at the Closing. (c) For the avoidance of doubt, if the Purchaser uses commercially reasonable best efforts to commence the FDA Phase 2 Trials and the delays occur for regulatory or other reasons beyond the control of the Purchaser, no Delay Fees shall be payable. (d) For avoidance of doubt, the Antev Vendors are entitled to the Delay Fees in addition to any Contingent Consideration that is due and payable pursuant to Section 2.3. (e) The Purchaser shall at all times act in good faith in its ownership of Antev and the Antev Intellectual Property, and the operation of Antev's business, and shall not knowingly do (or omit to do) anything with the intention of artificially reducing the Contingent Consideration.
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Related to FDA Trials

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study 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 Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus.

  • 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, that are described in the Registration Statement, the Pricing Disclosure Package 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, the Pricing Disclosure Package 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, the Pricing Disclosure Package and the Prospectus, the Company 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, the Pricing Disclosure Package 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, the Pricing Disclosure Package or the Prospectus, the Company has 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, 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.