FDA Approval. The U.S. Food and Drug Administration has not delivered a letter of nonapproval, nor threatened to deliver such a letter, with respect to any product manufactured, marketed, licensed or developed by Rigel, or any product which Rigel intends to manufacture, market, license or develop.
FDA Approval. After due investigation, (i) the Company has no knowledge that any Governmental Authority, including, but not limited to, the FDA, will ultimately prohibit the marketing, sale, license or use in the United States or elsewhere of any product (including, but not limited to, EFAPROXYN) proposed to be developed, produced or marketed by the Company (each, a "Product"), (ii) to the Company's knowledge, the FDA has not prohibited any product or process from being marketed or used in the United States which product or process is substantially similar in function or composition to the Company's lead product candidate, EFAPROXYN, (iii) the Company has no Product on clinical hold nor does the Company have any reason to expect that any Product is reasonably likely to be placed on clinical hold, (iv) the Company has made available to WP all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company or any agent thereof relative to the development of its Products, including, but not limited to, EFAPROXYN, (v) none of the Company or its Affiliates or, to the Company's knowledge, its employees or agents, has ever been sanctioned, formally or otherwise, by the FDA, and (vi) there has not been any suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the Company or, to the knowledge of the Company, any current or former employee of the Company.
FDA Approval. Upon application to the United States Food and Drug Administration for the commercial sale of an in vitro diagnostic kit developed by LICENSEE that incorporates a Licensed Product as defined in Section 1.F.above, LICENSEE shall pay MAYO a one-time “Application Fee” of $25,000 within thirty (30) days of such FDA application by LICENSEE. Upon approval from the United States Food and Drug Administration for the commercial sale of an in vitro diagnostic kit developed by LICENSEE that incorporates a Licensed Product as defined in Section l.F.above, LICENSEE shall pay MAYO a one-time “Approval Fee” of $25,000 within thirty (30) days of such FDA approval.
FDA Approval. Rugby warrants that each Product is approved by the FDA for the uses set forth in the Product labeling.
FDA Approval. Notwithstanding the Ordinary Vesting Schedule, if the Company obtains FDA approval for BA-058 during the Employment Term, then then the Company will provide the Executive with accelerated vesting such that, as of the date of the FDA approval, the Option will vest with respect to twenty-five percent (25%) of the unvested shares subject to the Option, with such twenty-five percent (25%) portion taken pro rata from the unvested shares subject to the Option, and the remaining unvested shares subject to the Option, as reduced by this Section 5(d), shall continue to vest in accordance with the Ordinary Vesting Schedule, subject to the Executive’s continued employment with the Company on each applicable vesting date and the terms of the Plan and Stock Option Agreement.
FDA Approval. SVI will assist CPI, at CPI’s sole expense, in obtaining applicable regulatory and legal approvals for any New Lead developed under this Agreement or any product in which a New Lead is used, to the extent reasonably requested by CPI. Without limiting the foregoing, if CPI chooses to conduct one or more clinical trials relating to a New Lead or any product in which a New Lead is used, SVI will provide commercially reasonable cooperation and assistance to CPI, at CPI’s sole expense, in developing protocols relating to the trial and in conducting the trial, if requested by CPI. [***] Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.
FDA Approval. The Borrower shall have obtained FDA approval of the BIVIGAM Prior Approval Supplement, and the Administrative Agent shall have received evidence satisfactory to it of such approval.
FDA Approval. (a) To the Company’s knowledge, all clinical trials conducted by or for the benefit of the Company have been, and are being, conducted in material compliance with the applicable requirements of “Good Clinical Practice”, informed consent, and all applicable requirements relating to protection of human subjects contained in 21 C.F.R.;
(b) Except as set forth in Section 3.29 of the Disclosure Schedule, to the Company’s knowledge, all manufacturing operations currently conducted by or for the benefit of the Company relating to drugs for human use have been and are being conducted in material compliance with the FDA’s applicable current “Good Manufacturing Practice” regulations;
(c) To the Company’s knowledge, no product (co-)promoted by the Company has been recalled, suspended or discontinued in the United States as a result of any action by the FDA;
(d) The Company has not received any notice, and to its knowledge Allergan has not received any notice, that the FDA has commenced, or threatened to initiate, any action to withdraw approval, place marketing or sale restrictions, or request the recall of any product (co-)promoted by the Company, or commenced, or threatened to initiate, any action to enjoin or place restrictions on the production, sale, or marketing of any such products;
(e) The Company has no product on clinical hold nor has the Company received written notice indicating that any product is reasonably likely to be placed on clinical hold;
(f) Neither the Company nor any officer or employee of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar state law or regulation or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation; and
(g) The Company has made available to the Investor all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company or any agent thereof relative to the development of the Company’s products and in the possession of the Company.
FDA Approval. HMRI represents and warrants that the Product is approved by the FDA for the uses set forth in HMRI's labeling. COPLEY and HMRI agree to take xxx xxcessary action to obtain and maintain any approvals necessary to permit COPLEY to sell the Product undex xxx own name in the Territory in compliance with applicable federal and state drug laws. HMRI and COPLEY agree to coordinate with xxxx other concerning all changes to Product labeling.
FDA Approval. The Products shall have received approval for sale from the Food and Drug Administration.
