FDA Matters. (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials. (b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading. (c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded. (d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.
Appears in 15 contracts
Sources: Series B 2 Convertible Preferred Stock and Warrant Purchase Agreement, License Agreement (Radius Health, Inc.), Series B Convertible Preferred Stock and Warrant Purchase Agreement (Radius Health, Inc.)
FDA Matters. (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials.
(b) All of the Corporation’s submissions to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading.
(c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded.
(d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.
Appears in 4 contracts
Sources: Series a 1 Convertible Preferred Stock Purchase Agreement (Radius Health, Inc.), Series a 1 Convertible Preferred Stock Purchase Agreement (Radius Health, Inc.), Series a 1 Convertible Preferred Stock Purchase Agreement (Radius Health, Inc.)
FDA Matters. (a) The Corporation has (i) The Company has not tested, manufactured, distributed or sold any products or services prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1938, as amended, 21 U.S.C. § 201 et seq. and the regulations promulgated thereunder, or any corollary entity in any other jurisdiction. The Company has obtained, in all countries where it is marketing its products and services, all material Permits required by any Governmental Entity to sell, promote and market its products and services. Except as disclosed in SEC Reports, the Company has not received any written notice of, nor does the Company have any knowledge of any actions, citations, decisions, product recalls, medical device reports, information requests, warning letters or Section 305 notices, pertaining to the Company Business from the FDA or similar issues regulated by the FDA or any corollary entity in any other jurisdiction.
(ii) The Company has complied with all applicable Laws and Regulations in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, labeling, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates services and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) FDA or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trialsjurisdiction.
(biii) All of submissions made by the Corporation’s submissions Company to the FDA and any corollary entity in any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not materially misstate any of the statements or information included therein, or omit to state a material fact necessary to make the statements therein not materially misleading.
(civ) The Corporation Company has not committed any act, made any statement never been the subject of an FDA seizure or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excludedinjunction action.
(dv) To the Company’s knowledge, the Company has never been investigated for possible FDA criminal violations.
(vi) The Corporation Company has never received a FDA warning letter and has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the been in violation of applicable FDA under the Food, Drug & Cosmetics Act of 1976, as amended, rules and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entitymaterial respect.
Appears in 1 contract
FDA Matters. (a) The Corporation has (i) complied in all material respects with all applicable lawsAs to each of the product candidates of each of the Buyer and its Subsidiaries, regulations including compounds currently under research and/or development by the Company and specifications with respect subject to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all jurisdiction of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by FDA or any equivalent Governmental Authority in any legal jurisdiction other than the U.S. Food (each such product, a “Buyer Regulated Product”), such Buyer Regulated Product is being researched, developed, manufactured, stored and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and tested in compliance in all material respects with all applicable laws and Laws. During the stated protocols for such clinical trialspast two (2) years, neither the Buyer nor any of its Subsidiaries has received any written notice or other written communication from any Governmental Authority alleging any material violation by the Company of any Law applicable to a Buyer Regulated Product.
(b) All To the knowledge of the Corporation’s submissions Buyer, neither Buyer nor any of its Subsidiaries has made any untrue statement of a material fact or fraudulent statement to the FDA and or any corollary entity in Governmental Authority or otherwise failed to disclose a material fact required to be disclosed to the FDA or any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleadingGovernmental Authority.
(c) The Corporation All preclinical studies and clinical trials, and other studies and tests of any Buyer Regulated Product conducted by or on behalf of the Buyer or any of its Subsidiaries have been, and if still pending are being, conducted in material compliance, to the extent applicable with all applicable Laws, including the FDCA and its implementing regulations governing good laboratory practices and good clinical practices, and the respective counterparts thereof outside the United States. All clinical trials conducted by or for the benefit of the Company have been in the past three (3) years, and are being, conducted in material compliance with all applicable Laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, and 312 of the U.S. Code of Federal Regulations. No clinical trial conducted by or on behalf of the Buyer or any of its Subsidiaries has not committed been terminated or placed on clinical hold by the FDA for safety reasons prior to scheduled completion, and neither the FDA nor any actother applicable Governmental Authority, made clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Buyer or any statement of its Subsidiaries has initiated, or, to the Buyer’s knowledge, threatened to initiate, any action to place a clinical hold order on, or failed otherwise terminate or suspend, any proposed or ongoing clinical investigation of the Buyer Regulated Products conducted or proposed to make be conducted by or on behalf of the Buyer or any statement that would breach of its Subsidiaries, and any other standards comprising good clinical practices.
(d) All documents filed by the FDA’s policy Company with the FDA or any other Governmental Authority with respect to “Fraudthe Buyer Regulated Products, Untrue Statements or the manufacturing, handling, storage or shipment of Material Factsthe Buyer Regulated Products were, Briberyat the time of filing, true, complete and Illegal Gratuities” set forth accurate in 56 Fed. Reg. 46191 all material respects.
(September 10, 1991e) or Neither the Buyer nor any similar laws, rules or regulations, whether under the jurisdiction of its Subsidiaries has received any written notice that the FDA or a corollary entity in any other jurisdictionGovernmental Authority has commenced, and or, to the Buyer’s knowledge, threatened in writing to initiate, any amendments action to enjoin production of the Buyer Regulated Products at any of its or other modifications thereto. Neither its suppliers’ facilities.
(f) None of the Corporation Buyer, any of its Subsidiaries nor, to the Corporation’s Knowledgeknowledge of the Buyer, any officer, employee or agent of the Corporation Buyer or any of its Subsidiaries has been convicted of any crime or engaged in any conduct that has caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Section 335a 335a, or any similar state or foreign law law, rule or regulation of any other Governmental Authority, or (B) exclusion from federal health care programs under 42 U.S.C. Sections 1320a-7 or 1320a-7a, or any similar law, rule or regulation of any Governmental Authority.
(g) In the past three (3) years, neither the Buyer nor any of its Subsidiaries has received from any Governmental Authority (i) any warning letters, untitled letters, or similar written correspondence alleging material noncompliance by the Buyer or any of its Subsidiaries with applicable Laws, or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulationunresolved inspection reports and Form FDA 483s identifying material noncompliance with the FDCA. To the knowledge of the Buyer, and neither the Corporation nor, FDA nor any other Governmental Authority intends to the Corporation’s Knowledge, bring any such person has been so debarred or excludedaction against the Buyer and its Subsidiary.
(d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.
Appears in 1 contract
FDA Matters. (a) The Corporation has (i) complied in all material respects with all applicable lawsAs to each of the product candidates of the Company, regulations including compounds currently under research and/or development by the Company and specifications with respect subject to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all jurisdiction of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by FDA or any equivalent Governmental Authority in any legal jurisdiction other than the U.S. Food (including, for clarity, fosfomycin) (each such product, a “Company Regulated Product”), such Company Regulated Product is being researched, developed, manufactured, stored and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and tested in compliance in all material respects with all applicable laws and Laws. During the stated protocols for such clinical trialspast two (2) years, the Company has not received any written notice or other written communication from any Governmental Authority alleging any material violation by the Company of any Law applicable to a Company Regulated Product.
(b) All To the knowledge of the Corporation’s submissions Company, the Company has not made any untrue statement of a material fact or fraudulent statement to the FDA and or any corollary entity in Governmental Authority or otherwise failed to disclose a material fact required to be disclosed to the FDA or any other jurisdiction, whether oral, written or electronically delivered, were true, accurate and complete in all material respects as of the date made, and remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleadingGovernmental Authority.
(c) The Corporation All preclinical studies and clinical trials, and other studies and tests of any Company Regulated Product conducted by or on behalf of the Company have been, and if still pending are being, conducted in material compliance, to the extent applicable with all applicable Laws, including the FDCA and its implementing regulations governing good laboratory practices and good clinical practices, and the respective counterparts thereof outside the United States. All clinical trials conducted by or for the benefit of the Company have been in the past three (3) years, and are being, conducted in material compliance with all applicable Laws, including, without limitation, 21 C.F.R. Parts 50, 54, 56, and 312 of the U.S. Code of Federal Regulations. No clinical trial conducted by or on behalf of the Company has not committed been terminated or placed on clinical hold by the FDA for safety reasons prior to scheduled completion, and neither the FDA nor any actother applicable Governmental Authority, made clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company has initiated, or, to the Company’s knowledge, threatened to initiate, any statement action to place a clinical hold order on, or failed otherwise terminate or suspend, any proposed or ongoing clinical investigation of the Company Regulated Products conducted or proposed to make be conducted by or on behalf of the Company, and any statement that would breach other standards comprising good clinical practices.
(d) All documents filed by the FDA’s policy Company with the FDA or any other Governmental Authority with respect to “Fraudthe Company Regulated Products, Untrue Statements or the manufacturing, handling, storage or shipment of Material Factsthe Company Regulated Products were, Briberyat the time of filing, true, complete and Illegal Gratuities” set forth accurate in 56 Fed. Reg. 46191 all material respects.
(September 10, 1991e) or The Company has not received any similar laws, rules or regulations, whether under the jurisdiction of written notice that the FDA or a corollary entity in any other jurisdictionGovernmental Authority has commenced, and or, to the Company’s knowledge, threatened in writing to initiate, any amendments action to enjoin production of the Company Regulated Products at any of its or other modifications thereto. its suppliers’ facilities.
(f) Neither the Corporation Company nor, to the Corporation’s Knowledgeknowledge of the Company, any officer, employee or agent of the Corporation Company has been convicted of any crime or engaged in any conduct that has caused or would reasonably be expected to result in (iA) disqualification or debarment by the FDA under 21 U.S.C. Section 335a 335a, or any similar state or foreign law law, rule or regulation of any other Governmental Authority, or (B) exclusion from federal health care programs under 42 U.S.C. Sections 1320a-7 or 1320a-7a, or any similar law, rule or regulation of any Governmental Authority.
(g) Within the past three (3) years, the Company has not received from any Governmental Authority (i) any warning letters, untitled letters, or similar written correspondence alleging material noncompliance by the Company with applicable Laws, or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulationunresolved inspection reports and Form FDA 483s identifying material noncompliance with the FDCA. To the knowledge of the Company, and neither the Corporation nor, FDA nor any other Governmental Authority intends to the Corporation’s Knowledge, bring any such person has been so debarred or excludedaction against the Company.
(d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated thereunder, or any corollary entity in any jurisdiction. The Corporation has not received any notice of, nor is the Corporation aware of any, actions, citations, warning letters or Section 305 notices from the FDA or any corollary entity.
Appears in 1 contract