FDA Compliance. Except as set forth on Section 3.24 of the Company Disclosure Letter, or as would not have, either individually or in the aggregate, a Material Adverse Effect, to the Company’s knowledge: (a) (i) neither the Company nor any of its Subsidiaries is subject to any obligation arising under any consent decree, consent agreement, Official Action Indicated (OAI) status, warning letter or other notice, response or commitment made to or with the FDA, DEA or any comparable Governmental Entity; (ii) the Company and each of its Subsidiaries has made all notifications, submissions, information and reports required by any such obligation, and (iii) all such notifications, submissions, information and reports were true, complete and correct in all material respects as of the date of submission to FDA, DEA or any comparable Governmental Entity. (b) (i) since January 1, 2003, no products manufactured, marketed or sold by the Company or any of its Subsidiaries have been withdrawn, recalled or subject to a field correction or safety alert (whether voluntarily or otherwise), or been subject to a suspension of manufacturing; and (ii) there are no facts or circumstances reasonably likely to cause (x) the denial, withdrawal, recall, field notification, field correction, safety alert or suspension of manufacturing relating to any Company product; (y) a material change in the labeling of any Company product; or (z) a termination, seizure or suspension of marketing of any Company product. (c) neither the Company nor any of its Subsidiaries has received any notices, correspondence or other communication from the FDA or any other Governmental Entity requiring the termination, suspension or material modification of any clinical trials conducted by, or on behalf of, the Company or such Subsidiary, or in which the Company or such Subsidiary has participated, and there is no reason to believe that the FDA or any other Governmental Entity is considering such action.
Appears in 2 contracts
Samples: Merger Agreement (Andrx Corp /De/), Merger Agreement (Watson Pharmaceuticals Inc)
FDA Compliance. Except as Each of the representations and warranties set forth in this Section 2.25 is subject in all respects to the qualifications and disclosures set forth on Section 3.24 of the Company Disclosure Letter, or as would not have, either individually or in the aggregate, a Material Adverse Effect, to the Company’s knowledge:Schedule 2.25.
(a) As to each product that has been distributed and/or marketed by or on behalf of the Company or any Subsidiary in the United States, the Company and the Subsidiaries, where required, have obtained all material regulatory and other approvals prerequisite to the commercial sale, promotion or marketing, and each such product (i) is not a “device” within the meaning of the Food, Drug, and Cosmetic Act (21 U.S.C. §§ 301 et seq.) (the “FDCA”), (ii) is exempt from the requirements to submit a 510(k) premarket notification and is exempt from the requirements to submit an application for premarket approval or (iii) is covered by a clearance letter or other written order issued by the Food and Drug Administration pursuant to the 510(k) process.
(b) There are no, and since January 1, 2010 there have been no, material proceedings by any Governmental Authority pending or otherwise threatened in writing seeking the recall, repair, replacement, refund of the purchase price, correction, removal, withdrawal, suspension, seizure or discontinuance of any product against the Company or any Subsidiary.
(c) Since January 1, 2010, neither the Company nor any Subsidiary has received any written notice that the Food and Drug Administration, Department of its Subsidiaries is subject to Justice, nor has any obligation arising under any consent decree, consent agreement, Official Action Indicated (OAI) status, warning letter or other notice, response or commitment made to or with the FDA, DEA or any comparable Governmental Entity; (ii) the Company and each of its Subsidiaries has made all notifications, submissions, information and reports required by any such obligation, and (iii) all such notifications, submissions, information and reports were true, complete and correct in all material respects as of the date of submission to FDA, DEA or any comparable Governmental Entity.
(b) Authority (i) since January 1, 2003, no products manufactured, marketed or sold by requested in writing that the Company or any of its Subsidiaries have been withdrawnSubsidiary recall, recalled or subject to a field correction or safety alert (whether voluntarily or otherwise)repair, replace, or been subject to a suspension refund the purchase price of manufacturing; and any product, (ii) there are no facts commenced, or circumstances reasonably likely threatened in writing to cause (x) initiate, any action or enforcement proceeding to require the denial, withdrawal, recall, field notificationrepair, field correction, safety alert replacement or suspension refund of manufacturing relating to any Company product; (y) a material change in the labeling purchase price of any Company product; product or (ziii) a terminationcommenced, seizure or suspension of marketing threatened in writing to initiate, any action to enjoin distribution of any Company productMedical Device.
(cd) Since January 1, 2010, neither the Company nor any of its Subsidiaries Subsidiary has received any noticesFDA Form 483, notice of adverse finding, “warning letter,” “untitled letter” or similar written correspondence or other communication notice from the FDA or any other Governmental Entity requiring Authority (i) alleging or asserting material noncompliance with any applicable Laws or Permits or (ii) contesting the terminationinvestigational device exemption, suspension premarket clearance, approval, marketing, uses, labeling or material modification promotion of any clinical trials conducted by, products.
(e) Neither the Company nor any Subsidiary has made any change to any product that would require a further 510(k) submission.
(f) As to each product that has been distributed and/or marketed by or on behalf ofof the Company or any Subsidiary in the United States and that is a “device” within the meaning of the FDCA, the Company and each Subsidiary is in material compliance with the applicable regulations governing the registration of facilities, listing of products, retention of records, mandatory reports, labeling, good manufacturing practices and quality systems.
(g) Since January 1, 2010, no foreign Government Authority has refused entry of any product on the basis of material noncompliance with applicable legislative or such Subsidiary, regulatory requirements.
(h) As to each product that has been distributed and/or marketed by or in which on behalf of the Company or such any Subsidiary has participatedoutside of the United States, the Company and the Subsidiaries are in material compliance with the applicable registration, listing, approval, labeling, good manufacturing practice, quality control, record-keeping, and there is no reason to believe that the FDA or any reporting laws, regulations and other Governmental Entity is considering such actionlegal requirements.
Appears in 2 contracts
Samples: Securities Purchase Agreement, Securities Purchase Agreement (Gsi Group Inc)
FDA Compliance. Except as set forth on Section 3.24 of the Company Disclosure Letter, or as would not have, either individually or in the aggregate, a Material Adverse Effect, to the Company’s knowledge:
(a) The Company and its Subsidiaries are currently conducting, and have conducted, their business and operations in compliance in all material respects with all applicable provisions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§ 301 et seq., all applicable regulations promulgated by the United States Food and Drug Administration or any similar foreign Governmental Entity, as applicable (i“FDA”), and all other FDA Laws. Except as identified on Section 4.21(a) of the Disclosure Schedule, neither the Company nor its Subsidiaries have received in the past five (5) years any written notice, Form FDA-483, FDA warning letters or “untitled letters,” from the FDA alleging or asserting non-compliance with any applicable FDA Law or any other communication alleging actual or potential violations of FDA Law. Neither the Company nor any of its Subsidiaries have entered into any consent decree or order pursuant to any FDA Law, and neither the Company nor any of its Subsidiaries is subject a party to any obligation arising under any consent judgment, decree, consent agreementor judicial or administrative order pursuant to any FDA Law. There is no civil, Official Action Indicated (OAI) statuscriminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter letter, Form FDA 483, proceeding or other request for information pending against the Company or its Subsidiaries and neither the Company nor any of its Subsidiaries have any material liability (whether actual or contingent) for failure to comply with any FDA Law. To the Company’s Knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, response demand letter, warning letter, proceeding or commitment made to request for information or any such liability.
(b) The Company and its Subsidiaries do not manufacture, market or distribute any FDA regulated products that either require or are the subject of applicable FDA clearances, approvals, licenses, or permits, as the case may be, that are owned by the Company or its Subsidiaries, or any FDA products that are owned by the Company or its Subsidiaries and exempt from such FDA clearance, approval, license or permit requirements in accordance with FDA Law. To the Company’s Knowledge, all finished FDA regulated products that are contract manufactured, prepared or propagated by the Company or its Subsidiaries are the subject of an appropriate clearance or approval issued by FDA, DEA as required, and duly held by the party for whom the Company or its Subsidiaries is manufacturing, preparing or propagating such finished FDA regulated product, or such product is otherwise exempt from such FDA clearance, approval, license or permit requirements in accordance with FDA Laws. The Company and its Subsidiaries have obtained and maintained in full force and effect, all necessary establishment registrations, and device listings needed for the continuing operation of the AT Business and the business conducted by the DMS Entities, in each case, as listed on Section 4.21(b) of the Disclosure Schedule.
(c) Except where any comparable Governmental Entity; (ii) such non-compliance has not been and would not reasonably be expected to be material to the Company and its Subsidiaries, taken as a whole, the Company and its Subsidiaries are and have each been for the past five (5) years, in compliance with, and each product of the Company and its Subsidiaries subject to regulation by the FDA that is in commercial distribution while in the care, custody and control of the Company and its Subsidiaries have been designed (to the extent that such design is under the control of the Company or any of its Subsidiaries), manufactured, prepared, assembled, packaged, labeled, stored, and processed in compliance with current Good Manufacturing Practices, including, where applicable the Quality System Regulation. With respect to articles that are manufactured or assembled by the Company or its Subsidiaries has that are not finished products (e.g., components), and where such compliance is required by contract, the Company and its Subsidiaries have operated in compliance with, and each component while in the care, custody and control of the Company or its Subsidiaries has, as applicable, been manufactured, prepared, assembled, packaged, labeled, stored and processed in compliance in all material respects with current Good Manufacturing Practices, including, where applicable, the Quality System Regulation.
(d) The Company and its Subsidiaries have made all material notifications, submissions, information submissions and reports to the FDA required by any such obligationFDA Law, and (iii) all such notifications, submissions, information submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA (or were corrected or supplemented by a subsequent notification, submission or report). Neither the Company nor its Subsidiaries have made any untrue statement of a material fact or fraudulent statement to the FDA; failed to disclose a material fact required to be disclosed to the FDA; or committed an act, DEA made a statement, or any comparable Governmental Entityfailed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991).
(be) Neither the Company nor any Subsidiaries nor any of its employees and to the Company’s Knowledge, any of its contractors, has been, or to the Company’s Knowledge, is in anticipation of being debarred pursuant to the Generic Drug Enforcement Act of 1992 (21 U.S.C. § 335a(m)).
(f) With the exception of those items identified on Section 4.21(f) of the Disclosure Schedule, none of the Company, its Subsidiaries, or, to the Company’s Knowledge, any of their customers, has undertaken a recall, field correction, removal or withdrawal of any: (i) since January 1products (e.g., 2003, no products manufactured, marketed finished medical devices or sold components) manufactured by the Company or any of its Subsidiaries have been withdrawn, recalled or subject to a field correction or safety alert (whether voluntarily or otherwise), or been subject to a suspension of manufacturing; and (ii) finished medical devices that incorporate the Company’s or its Subsidiaries’ manufactured products (e.g., components) due to the failure of any such Company’s or Subsidiaries’ manufactured product’s failure to meet specifications or otherwise perform as intended, nor have any such products been seized, detained, subject to suspension of manufacturing or termination or suspension of marketing. To the Company’s Knowledge, there are no facts or circumstances reasonably likely to cause (x) the denial, withdrawal, such recall, field notification, field correction, safety alert or removal, withdrawal, seizure, detention, suspension of manufacturing relating to any Company product; (y) a material change in the labeling of any Company product; or (z) a termination, seizure termination or suspension of marketing of any Company product.
(cg) neither the The Company nor any of and its Subsidiaries has received have not conducted any notices, correspondence or other communication from clinical studies in the FDA or any other Governmental Entity requiring United States nor sponsored the termination, suspension or material modification conduct of any clinical trials conducted by, or on behalf of, research in the Company or such Subsidiary, or in which the Company or such Subsidiary has participated, and there is no reason to believe that the FDA or any other Governmental Entity is considering such actionUnited States.
Appears in 1 contract
Samples: Merger Agreement (Nordson Corp)
FDA Compliance. Except as set forth on Section 3.24 of the Company Disclosure Letter, or as would not have, either individually or in the aggregate, a Material Adverse Effect, to the Company’s knowledge:
(a) (i) neither the Company nor any of its Subsidiaries is As to each product or product candidate subject to any obligation arising the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under any consent decreethe Federal Food, consent agreementDrug and Cosmetic Act, Official Action Indicated (OAI) status, warning letter or other notice, response or commitment made to or with the FDA, DEA or any comparable Governmental Entity; (ii) the Company and each of its Subsidiaries has made all notifications, submissions, information and reports required by any such obligationas amended, and the regulations thereunder (iii“FDCA”) all such notifications, submissions, information and reports were true, complete and correct in all material respects as of the date of submission to FDA, DEA or any comparable Governmental Entity.
(b) (i) since January 1, 2003, no products that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed or sold by the Company or any of its Subsidiaries have been withdrawnsubsidiaries (each such product, recalled or subject to a field correction or safety alert (whether voluntarily or otherwise“Pharmaceutical Product”), or been subject to a suspension of manufacturing; and (ii) there are no facts or circumstances reasonably likely to cause (x) the denialsuch Pharmaceutical Product is being manufactured, withdrawalpackaged, recalllabeled, field notificationtested, field correctiondistributed, safety alert or suspension of manufacturing relating to any Company product; (y) a material change in the labeling of any Company product; or (z) a termination, seizure or suspension of marketing of any Company product.
(c) neither sold and/or marketed by the Company nor in compliance with all applicable requirements under FDCA and all applicable Good Laboratory Practices (as set forth in 21 CFR Part 58), Good Clinical Practices (as set forth in 21 XXX Xxxx 00, 00 XXX Part 54, 21 CFR 56, and 21 CFR Part 312) and Good Manufacturing Practices (as set forth in 21 CFR Part 211), except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries subsidiaries, and none of the Company or any of its subsidiaries has received any noticesnotice, correspondence warning letter or other communication from the FDA or any other Governmental Entity requiring governmental entity, which: (i) contests the terminationpremarket clearance, suspension or material modification of any clinical trials conducted bylicensure, registration, or on behalf approval of, the Company uses of, the distribution of, the manufacturing or such Subsidiarypackaging of, the testing of, the sale of, or in which the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or such Subsidiary has participatedany of its subsidiaries, (iv) enjoins production at any facility of the Company or any of its subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its subsidiaries, and there is no reason to believe which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any other Governmental Entity is considering such actionproduct proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for the testing, marketing any product being developed or proposed to be developed by the Company.
Appears in 1 contract