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.
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.
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.