FDA and Related Matters. (a) Parent and its Affiliates possess all Registrations required to conduct the Business as currently conducted, and Section 3.11(a) of the Seller Disclosure Schedule sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parent, (i) neither the FDA nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Products, and there is no false or misleading information or material omission in any Product application or other submission, notification or report to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are in compliance with and have fulfilled and performed in all material respects their respective obligations under each such Registration, and, to the Knowledge of Parent, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parent, any third Person that is a manufacturer or contractor for Parent or any of its Affiliates is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts or Products for Parent or any of its Affiliates, as applicable. (b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is developed, manufactured, tested, distributed and/or marketed by or on behalf of the Business, each such Product is being developed, manufactured, tested, distributed and/or marketed in material compliance with all applicable requirements under the FDCA and similar Laws, including those relating to investigational use, premarket clearance or marketing approval to market such Product, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record keeping, training, medical device reporting, adverse event reporting, filing of other reports and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Law. To the Knowledge of Parent, any third Person that is a manufacturer or contractor for Parent or any Affiliate is in compliance with all FDA Laws or any other Law insofar as they pertain to the manufacture of Product components, accessories, parts or Products for Parent or any Affiliate. (c) With respect to the Business or the Products, there are no Actions pending or threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental Authority. Neither Parent nor any of its Affiliates has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any Laws in relation to the Business or any of the Products. Parent and all of its Affiliates have made all notifications, submissions, responses and reports as required by FDA Laws or any other applicable Law in relation to the Business or the Products, which were true and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parent, no basis for liability exists with respect to any such notifications, submissions, or reports. (d) Except as set forth in Section 3.11(c) of the Seller Disclosure Schedule, as of the Closing Date, no Product developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental Authority. (e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical Practices, applicable research protocols, institutional review board or other ethics committee requirements, patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products has been terminated, materially delayed, limited, suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial. (f) With respect to the Business, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw its approval or request the recall of any Product, (ii) commenced, or threatened to initiate, any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packaged.
Appears in 2 contracts
Sources: Asset Purchase Agreement (Minerva Surgical Inc), Asset Purchase Agreement (Minerva Surgical Inc)
FDA and Related Matters. (a) Parent The Company and its Affiliates each Company Subsidiary possess all Registrations required to conduct the Business their respective businesses as currently conducted, and Section 3.11(a3.21(a) of the Seller Company Disclosure Schedule Letter sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parentthe Company, (i) neither the FDA U.S. Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Productsproducts of the Company and any Company Subsidiary. To the Knowledge of the Company, and there is no material false or misleading information or material omission in any Product product application or other submission, notification or report to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent The Company and its Affiliates each Company Subsidiary are in compliance with with, and have fulfilled and performed in all material respects their respective obligations under under, each such Registration, and, to the Knowledge of Parentthe Company, no event has occurred or condition or state of facts exists which would constitute a material breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Company, any third Person that is a manufacturer or contractor for Parent the Company or any of its Affiliates Company Subsidiary is in compliance in all material respects with all Registrations insofar as they pertain to the manufacture of Product product components, accessories, parts or Products products for Parent the Company or any of its AffiliatesCompany Subsidiary, as applicable.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is All products developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported or exported by or on behalf of the Business, each such Product is Company or any Company Subsidiary that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Authority have been and are being developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects in compliance with all applicable requirements under FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Authority that has jurisdiction over the FDCA and similar Lawsoperations of the Company or any Company Subsidiary, or any other Law, including those relating with respect to investigational usenon-clinical research, clinical research, establishment registration, device listing, premarket clearance or marketing approval to market such Productnotification, good manufacturing practicesquality system regulation, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing and malfunction reporting and reporting of other reports corrections and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Lawremovals. To the Knowledge of Parentthe Company, except as would not be material to the Company and each Company Subsidiary, taken as a whole, any third Person that is a manufacturer or contractor for Parent the Company or any Affiliate Company Subsidiary is in compliance with all FDA Laws or any other Law insofar as they pertain to the manufacture of Product product components, accessories, parts or Products products for Parent the Company or any AffiliateCompany Subsidiary.
(c) With respect to the Business or the Products, there There are no Actions Proceedings pending or threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental AuthorityAuthority that has jurisdiction over the operations of the Company and any Company Subsidiary. Neither Parent Except as set forth in Section 3.21(c) of the Company Disclosure Letter, neither the Company nor any of its Affiliates Company Subsidiary has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any Laws in relation or Registrations. Neither the Company nor any Company Subsidiary is subject to any obligation arising under an administrative, enforcement or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the Business FDA or any of the Productscomparable Regulatory Authority or Governmental Authority. Parent The Company and all of its Affiliates have each Company Subsidiary has made all notifications, submissions, responses and reports as required by FDA Laws or any other applicable Law in relation Law, including any such obligation arising under any administrative, enforcement or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the Business FDA or the Productsany comparable Regulatory Authority or Governmental Authority and all such notifications, which submissions and reports were true correct and correct complete in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parentthe Company, no basis for liability exists with respect to any such notificationsnotification, submissionssubmission, or reportsreport.
(d) Except as set forth in Section 3.11(c3.21(d) of the Seller Company Disclosure ScheduleLetter, as no product distributed or sold by or on behalf of the Closing DateCompany or any Company Subsidiary has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, there are no Product facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product, (ii) a change in the labeling of any such product or (iii) a termination, seizure, or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such product. No Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, removal, suspension, import detention, seizure or similar action of any such product are pending or threatened in writing against the Company or Company Subsidiary. Neither the Company nor any Company Subsidiary has received any notice from the FDA or any comparable Regulatory Authority or Governmental Authority that any product distributed or sold by or on behalf of the Company or any Company Subsidiary cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental AuthorityCompany.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Company Subsidiary have been and are being conducted in material compliance with all applicable Laws and other requirementsLaws, including Good Clinical PracticesFDA Laws, applicable research protocols, institutional review board or other ethics committee requirements, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Company Subsidiary has been terminated, materially delayed, limited, suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect to the Business, since January 1, 2017, none of Parent or its Affiliates has received any written notice that and neither the FDA nor any other applicable Governmental Authority or Regulatory Authority, nor any institutional review board or other ethics committee that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company or any other Governmental Authority Company Subsidiary, has (i) ordered or commenced, or threatened in writing to initiate, any action to withdraw its approval place a clinical hold order on, or request otherwise terminate, materially delay, or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the recall Company or any Company Subsidiary or, to the Knowledge of the Company, alleged any violation of any ProductFDA Law in connection with any such clinical trial.
(f) To the Knowledge of the Company, (ii) commenced, all data generated by the Company and any Company Subsidiary with respect to their respective products that has been provided to their respective customers or threatened to initiate, any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product otherwise made public is manufactured, tested or packagedaccurate and truthful in all material respects.
Appears in 1 contract
Sources: Merger Agreement (Invuity, Inc.)
FDA and Related Matters. (a) Parent The Company and its Affiliates possess each Company Subsidiary holds, and is operating in material compliance with, all material Registrations required to conduct the Business business of the Company and the Company Subsidiaries as currently conducted, and Section 3.11(a2.21(a) of the Seller Disclosure Schedule sets forth a true, complete and correct and complete list as of the date of this Agreement hereof of such Registrations. Each such Registration of the Registrations is valid and subsisting in full force and effect. Neither the Company nor any Company Subsidiary has received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from a Regulatory Authority or other Governmental Entity alleging that any operation or activity of the Company or any Company Subsidiary is in violation of the Registrations. To the Knowledge of ParentCompany’s Knowledge, (i) neither the FDA United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Authority Entity is considering materially limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Products. Except as would not reasonably be expected to have a material impact on the Company, there has not been and there is currently no false or misleading information or material omission in any Product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental AuthorityEntity. Parent Except as would not reasonably be expected to have a material impact on the Company, the Company and its Affiliates are in compliance with and have each Company Subsidiary has fulfilled and performed in all material respects their respective its obligations under each such Registration, and, to the Knowledge of Parent, and no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of ParentCompany’s Knowledge, and except as would not reasonably be expected to have a material impact on the Company, any third Person party that is a manufacturer or contractor for Parent the Company or any of its Affiliates Company Subsidiary is in compliance with all Registrations insofar as they pertain to to, or affect, the manufacture of Product components, accessories, parts components or Products for Parent the Company or any of its Affiliates, as applicableCompany Subsidiary.
(b) As Except as would not reasonably be expected to each Product subject to have a material impact on the FDCA or similar Law in any foreign jurisdiction that is Company, all Products developed, tested, investigated, manufactured, testedprocessed, distributed and/or marketed produced, distributed, advertised, commercialized, marketed, imported, exported or sold by or on behalf of the Business, each such Product is Company or any Company Subsidiary that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Entity have been and are being developed, tested, investigated, manufactured, testedprocessed, distributed and/or marketed produced, distributed, advertised, commercialized, marketed, imported, exported and sold in material compliance with all FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company or such Company Subsidiary, as applicable, and any other applicable requirements under the FDCA and similar LawsLaw, including those relating to investigational useregarding non-clinical research, premarket clearance or marketing approval to clinical research, establishment registration, device listing, pre-market such Productnotification and pre-market approval, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing reporting and reporting of other reports corrections and securityremovals. Except as set forth would not reasonably be expected to have a material impact on the Company, the Company has operated in Section 3.11(a) compliance with applicable Laws related to the testing, investigation, manufacturing, processing, production, distribution, advertising, commercialization, marketing, import, export, and sale of the Seller Disclosure Scheduleits Products, none of Parent or its Affiliates has received any notice or other communication from including, without limitation, the FDA or Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Authority (i) contesting the premarket clearance or approval ofEntity, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation other applicable to any such Product of any LawLaws. To the Knowledge of ParentCompany’s Knowledge, except as would not reasonably be expected to have a material impact on the Company any third Person party that is a manufacturer or contractor for Parent the Company or any Affiliate Company Subsidiary is in compliance with all FDA Laws, any comparable Laws or enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of the Company and any other applicable Law insofar as they pertain to to, or affect, the manufacture of Product components, accessories, parts components or Products for Parent the Company or any Affiliatesuch Company Subsidiary.
(c) With respect to the Business or the Products, there There are no Actions enforcement actions (including any administrative Proceeding, prosecution, injunction, seizure, civil penalty, exclusion or debarment action) pending or threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental AuthorityEntity that has jurisdiction over the operations of the Company or any Company Subsidiary. Neither Parent the Company nor any Company Subsidiary has had any Product or manufacturing site (whether Company or Company Subsidiary-owned or that of its Affiliates has a contract manufacturer for Products) subject to a Regulatory Authority or Governmental Entity (including FDA) shutdown or import or export prohibition, or received any Form FDA-483FDA-483 or other Governmental Entity notice of inspectional observations, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, ,” notice of FDA action for import detention or refusal, or any other written notice of an adverse action from the FDA or other Governmental Entity alleging or asserting material noncompliance with any applicable Laws or Registrations, or requests or requirements to make changes to the Products that if not complied with could have a material impact on the Products or the Company. Neither the Company nor any Company Subsidiary is subject to any obligation arising under an administrative or regulatory action, FDA or other Governmental Entity inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity, or any other written communication from any Regulatory Authority or Governmental Entity alleging or asserting material noncompliance with any Laws in relation to applicable Laws, including the Business or any of the ProductsFDA Laws. Parent The Company and all of its Affiliates have each Company Subsidiary has made all applications, notifications, submissions, responses information, claims and reports as required by FDA Laws or any other applicable Law in relation Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response or commitment made to or with the Business FDA or the Productsany comparable Regulatory Authority or Governmental Entity and all such notifications, which submissions and reports were true true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental AuthorityEntity, and any necessary or required updates, changes, corrections, or modification to such applications, notifications, submissions, information, claims and reports have been submitted to such Regulatory Authority or other Governmental Entity. To the Knowledge of ParentCompany’s Knowledge, no basis for liability exists with respect to any such notificationsnotification, submissionssubmission, information, claim or reportsreport. To the extent any adverse events have occurred, any and all known adverse events have been reported to FDA as required by the FDA Laws.
(d) Except as set forth in on Section 3.11(c2.21(d) of the Seller Disclosure Schedule, as of the Closing Date, no Product developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported distributed or exported sold by or on behalf of Parent the Company or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or Company Subsidiary has been recalled, seized, withdrawn, or detained; recalled, detained or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect and to the Products and the BusinessCompany’s Knowledge, there are no facts or circumstances reasonably likely to cause an administrative(i) the seizure, regulatorydenial, enforcementwithdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such Product; (ii) a material change in the labeling of any such Product; or (iii) a termination, seizure or suspension of the marketing or distribution (including for commercial, investigational or any other adverse action by use) of any such Product. No Proceedings in the FDA United States or similar Regulatory Authority any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or Governmental Authorityseizure of any such Product are pending or, to Company’s Knowledge, threatened against the Company or any Company Subsidiary.
(e) All preclinical The clinical, pre-clinical and clinical investigations sponsored or other studies and tests conducted by or on behalf of Parent or sponsored by the Company or any of its Affiliates relating to Company Subsidiary or in which the Business Company, any Company Subsidiary or any of the their Products have been and participated were and, if still pending, are being conducted in material compliance accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the FDA Laws and other requirementsFDA’s applicable implementing regulations at 21 C.F.R. Parts 50, including Good Clinical Practices54, applicable research protocols56, institutional review board or other ethics committee requirements58 and 812, patient privacy requirements or restricting except as would not reasonably be expected to have a material impact on the use and disclosure Company. Except to the extent disclosed on Section 2.21(e) of individually identifiable health information. No clinical trial sponsored or conducted the Disclosure Schedule, no investigational device exemption filed by or on behalf of Parent the Company or any of its Affiliates relating to Company Subsidiary with the Business or any of the Products FDA has been terminated, materially delayed, limited, terminated or suspended or placed on clinical hold prior to completion by the FDA, and neither the FDA nor any other applicable Governmental Authority or Regulatory Authorityforeign regulatory agency has commenced, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect or, to the BusinessCompany’s Knowledge, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any Company Subsidiary. To the Company’s Knowledge, all data generated by the Company and each Company Subsidiary with respect to its approval Products that has been provided to its customers or request otherwise made public is truthful and not misleading.
(f) Neither the recall Company nor any Company Subsidiary is the subject of any Productpending or, to the Company’s Knowledge, threatened investigation in respect of the Company, any Company Subsidiary or any Products by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of the Company, any Company Subsidiary or any of their respective officers, employees or agents has been convicted of any crime or engaged in any conduct that could result in a debarment or exclusion (i) under 21 U.S.C. Section 335a or (ii) commencedany similar Law. As of the date hereof, to the Company’s Knowledge, no claims, actions, proceedings or investigations that would reasonably be expected to result in such a debarment or exclusion are pending or threatened to initiateagainst the Company or any Company Subsidiary or any of their respective officers, any action to enjoin production of any Product, employees or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packagedagents.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Pacira Pharmaceuticals, Inc.)
FDA and Related Matters. (ai) Parent and its Affiliates The Company possess all Registrations required to conduct the Business its businesses as currently conducted, and Section 3.11(a3.01(aa)(i) of the Seller Company Disclosure Schedule Letter sets forth a true, complete and correct and complete list as of the date of this Agreement of such material Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge knowledge of Parentthe Company, (i) as of the date of this Agreement, neither the FDA United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Productsproducts of the Company. To the knowledge of the Company, and there is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are The Company is in compliance with with, and have has fulfilled and performed in all material respects their respective its obligations under under, each such Registration, and, as of the date of this Agreement, to the Knowledge knowledge of Parentthe Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge knowledge of Parentthe Company, any third Person person that is a manufacturer or contractor for Parent or any of its Affiliates the Company is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent or any of its Affiliates, as applicablethe Company.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is developed, manufactured, tested, distributed and/or marketed by or on behalf of the Business, each such Product is being developed, manufactured, tested, distributed and/or marketed in material compliance with all applicable requirements under the FDCA and similar Laws, including those relating to investigational use, premarket clearance or marketing approval to market such Product, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record keeping, training, medical device reporting, adverse event reporting, filing of other reports and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Law. To the Knowledge of Parent, any third Person that is a manufacturer or contractor for Parent or any Affiliate is in compliance with all FDA Laws or any other Law insofar as they pertain to the manufacture of Product components, accessories, parts or Products for Parent or any Affiliate.
(c) With respect to the Business or the Products, there are no Actions pending or threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental Authority. Neither Parent nor any of its Affiliates has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any Laws in relation to the Business or any of the Products. Parent and all of its Affiliates have made all notifications, submissions, responses and reports as required by FDA Laws or any other applicable Law in relation to the Business or the Products, which were true and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parent, no basis for liability exists with respect to any such notifications, submissions, or reports.
(d) Except as set forth in Section 3.11(c) of the Seller Disclosure Schedule, as of the Closing Date, no Product All products developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of Parent the Company that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Authority have been and are being developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects in compliance with FDA Laws, any comparable laws enforced by any other Regulatory Authority or Governmental Authority that has jurisdiction over the operations of its Affiliates the Company, or any other applicable law, including those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals. To the knowledge of the Company, except as would not be material to the Company, taken as a whole, any third person that is a manufacturer or contractor for the Company is in compliance with all FDA Laws or any other applicable law insofar as they pertain to the manufacture of product components or products for the Company.
(iii) To the knowledge of the Company, there are no Proceedings pending or threatened by or on behalf of the FDA or any other Regulatory Authority or Governmental Authority that has jurisdiction over the operations of the Company. The Company has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or any other Governmental Authority alleging or asserting noncompliance with any applicable laws or Registrations. The Company is not subject to any obligation arising under consideration for recallan administrative or regulatory action, withdrawalFDA inspection, suspensionFDA warning letter, seizure FDA notice of violation letter or discontinuance; other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Authority. The Company has made all notifications, submissions, responses and reports required by FDA Laws or any other applicable law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Authority and all such notifications, submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority.
(iv) Except as set forth on Section 3.01(aa)(iv) of the Company Disclosure Letter, no product distributed or sold by or on behalf of the Company has been recalled, seized, withdrawn, or detained; recalled, detained or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or and as of the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Businessdate of this Agreement, there are no facts or circumstances reasonably likely to cause an administrative(A) the seizure, regulatorydenial, enforcementwithdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; or (B) a termination, seizure, limitation, restriction, modification or suspension of the marketing or distribution (including for commercial, investigational or any other adverse action by use) of any such product. No Proceedings in the FDA United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure or similar action of any such product are pending or, to the knowledge of the Company, threatened against the Company. Since January 1, 2017, the Company has not received any written notice from a Regulatory Authority or other Governmental AuthorityAuthority that any product distributed or sold by or on behalf of the Company cannot be manufactured, distributed, marketed, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of the Company.
(ev) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products Company have been and are being conducted in material compliance with all applicable Laws laws and other requirements, including Good Clinical PracticesPractices requirements, other FDA Laws, applicable research protocols, institutional review board or other ethics committee requirementscorrective action plans, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products Company has been terminated, materially delayed, limited, limited or suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial, and neither the FDA nor any other applicable Governmental Authority or Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company, has ordered or commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay, limit, modify or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company, or, to the knowledge of the Company, alleged any violation of any FDA Law in connection with any such clinical trial.
(fvi) With respect to To the Businessknowledge of the Company, since January 1, 2017, none no promotional materials distributed by the Company for its products have been false or misleading under Section 502 of Parent or its Affiliates the Federal Food, Drug and Cosmetic Act, except as has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened not had and would not be reasonably expected to initiate, any action to withdraw its approval or request the recall of any Product, (ii) commenced, or threatened to initiate, any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packagedhave a Company Material Adverse Effect.
Appears in 1 contract
Sources: Merger Agreement (Avedro Inc)
FDA and Related Matters. (a) Parent and its Affiliates possess The Company has all Registrations required to conduct the Business as currently conducted, and Section 3.11(a3.27(a) of the Seller Disclosure Schedule of Exceptions sets forth a correct true and complete list as of the date of this Agreement of such Registrations. Each such Registration of the Registrations is valid and subsisting in full force and effect. To the Knowledge of Parentthe Company, (i) neither the FDA nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration Registrations or changing or challenging the marketing classification or labeling of the Products, products of the Company. The Company is in compliance in all material respects with all terms and there conditions of each Registration and all applicable reporting and other requirements for all Registrations. There is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are in compliance with and have The Company has fulfilled and performed in all material respects their respective its obligations under each such Registration, and, and to the Knowledge of Parentthe Company, no event has occurred or nor does any condition or state of facts exists exist which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Company, any third Person party that is a manufacturer or contractor for Parent or any of its Affiliates the Company is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent or any of its Affiliates, as applicablethe Company.
(b) All products developed, tested, investigated, manufactured, distributed, marketed, or sold by or on behalf of the Company that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, manufactured, distributed, marketed, and sold in compliance in all material respects with the FDCA, the Public Health Service Act, and any other applicable Law.
(c) There are no enforcement actions (including any administrative proceeding, data integrity review, prosecution, injunction, seizure, civil penalty, or debarment action) pending or, to the Knowledge of the Company, threatened by or on behalf of the FDA or any other Regulatory Authority that has jurisdiction over the operations of the Company, and to the Knowledge of the Company, no circumstances that would reasonably form the basis of any such action. The Company has never received any written notice from the FDA nor any comparable Regulatory Authority that remains unresolved (i) contesting the premarket clearance or approval of the uses of or the labeling and promotion of any Product or (ii) otherwise alleging any material violation of any Law applicable to the Products. The Company has previously provided to Parent true, correct and complete copies of (i) all such notices, and (ii) all correspondence between the Company and all Regulatory Authorities related thereto. Since January 1, 2012, the Company has not received any Form FDA-483, notice of adverse finding, FDA warning letters, notice of violation or “untitled letters,” notice of FDA action for import detentions or refusals, or any other notice from the FDA or other comparable Regulatory Authority alleging or asserting noncompliance with any applicable Laws or Registrations. The Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall or other field action, or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority. The Company has made all material notifications, submissions and reports required by the FDCA, the Public Health Service Act or any other applicable Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall or other field action or other notice, response, or commitment made to or with the FDA or any comparable Regulatory Authority and all such notifications, submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority (or were corrected in or supplemented by a subsequent filing). To the Company’s Knowledge, no basis for liability exists with respect to any such notification, submission, or report.
(d) No Product has been subject to any seizure, withdrawal, recall or other field action, detention, or suspension of manufacturing since January 1, 2012, and to the Knowledge of the Company, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (ii) a change in the labeling of any such product; or (iii) a termination, seizure or suspension of the marketing or distribution (including for commercial, investigational, or any other use) of any such product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such product are pending or, to the Knowledge of the Company, threatened against the Company.
(e) The Company has not initiated, conducted or sponsored any human clinical trials. The studies (including, without limitation, non-clinical laboratory studies), human clinical trials, tests and preclinical trials, if any, conducted by or on behalf of, or (if applicable) sponsored by, the Company to date (collectively, the “Studies”) were and, to the extent still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards and in accordance with all applicable Laws. The Company has not received any notices or correspondence from the 36 FDA or any other Governmental Entity exercising comparable authority, or any institutional review board or ethics board, requiring or requesting the termination, suspension or material modification of any Study. No Studies have been otherwise terminated by the Company due to safety concerns. Nothing in the currently existing regulatory data, clinical data and other technical information (including, without limitation, any design history files, data and information) contained in and/or referenced by any Study submitted, or to be submitted, by the Company to a Governmental Entity, and any data bases incorporating any such data and information, related to the Company’s products (“Regulatory Data”) contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained in such Regulatory Data not misleading.
(f) Neither the Company nor, to the Knowledge of the Company, any officer, employee or agent of the Company, has (i) been subject to any fine, injunction, civil penalty or other enforcement action by the FDA, or (ii) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity or in any records or documents prepared or maintained to comply with applicable Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, could reasonably be expected to provide a basis for the FDA or any other Governmental Entity 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) or any similar policy.
(g) As to each Product product subject to the FDCA FDCA, or similar Law in any foreign jurisdiction jurisdiction, that is developed, manufactured, tested, distributed and/or marketed or investigated by or on behalf of the BusinessCompany (a “Medical Device”), each such Product Medical Device is being developed, manufactured, tested, investigated, distributed and/or and marketed by the Company in material compliance with all applicable requirements under the FDCA and similar Laws, including those relating to non-clinical research, clinical research, establishment registration, device listing, investigational use, premarket clearance or marketing approval to market such Producta Medical Device, post-market surveillance, good manufacturing practices, labeling, advertising, advertising and promotion, continuing medical education, record keeping, trainingproduct design and development, medical device reportingproduct sales and distribution, adverse event reportingMedical Device importation and exportation, filing of other reports and security, and in compliance with the Advanced Medical Technology Association Code of Ethics on Interactions with Healthcare Professionals and the American Medical Association’s guidelines on gifts to physicians, except for failures that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates The Company has not received any notice or other communication from the FDA or any other Governmental Authority Entity (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the BusinessCompany’s products, or (ii) otherwise alleging any material violation applicable to any such Product Medical Device of any applicable Law. To the Knowledge of Parent, any third Person that is a manufacturer or contractor for Parent or any Affiliate is in compliance with all FDA Laws or any other Law insofar as they pertain to the manufacture of Product components, accessories, parts or Products for Parent or any Affiliate.
(ch) With respect to the Business or the Products, there are no Actions pending or threatened in writing by or on behalf No article of the FDA or any other Regulatory Authority or Governmental Authority. Neither Parent nor any of its Affiliates has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any Laws in relation to the Business or any of the Products. Parent and all of its Affiliates have made all notifications, submissions, responses and reports as required by FDA Laws or any other applicable Law in relation to the Business or the Products, which were true and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parent, no basis for liability exists with respect to any such notifications, submissions, or reports.
(d) Except as set forth in Section 3.11(c) of the Seller Disclosure Schedule, as of the Closing Date, no Product developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of Parent or any of its Affiliates Medical Device is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental Authority.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical Practices, applicable research protocols, institutional review board or other ethics committee requirements, patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products has been terminated, materially delayed, limited, suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect to the Business, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, adulterated within the meaning of 21 U.S.C. § 351 (or threatened to initiate, any action to withdraw its approval or request the recall of any Productsimilar Law), (ii) commenced, misbranded within the meaning of 21 U.S.C. § 352 (or threatened to initiate, any action to enjoin production of any Productsimilar Law), or (iii) commenced, a product that is in violation of 21 U.S.C. § 360 or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested § 360e (or packagedsimilar Law).
Appears in 1 contract
FDA and Related Matters. (a) Parent The Company and its Affiliates Subsidiaries possess all Registrations required to conduct the Business their respective businesses as currently conducted, and Section 3.11(a) of the Seller Disclosure Schedule sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parentthe Company, (i) as of the date hereof, neither the FDA United States Food and Drug Administration (the “FDAˮ) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Productsproducts of the Company and any of its Subsidiaries. To the Knowledge of the Company, and there is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent The Company and each of its Affiliates Subsidiaries are in compliance with with, and have fulfilled and performed in all material respects their respective obligations under under, each such Registration, and, as of the date hereof, to the Knowledge of Parentthe Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Company, any third Person that is a manufacturer or contractor for Parent the Company or any of its Affiliates Subsidiaries is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent the Company or any of its AffiliatesSubsidiaries, as applicable.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is All products developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported or exported by or on behalf of the Business, each such Product is Company or any of its Subsidiaries that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects, in compliance with all applicable requirements under FDA Laws, and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the FDCA and similar Lawsoperations of the Company or any of its Subsidiaries, including those relating to investigational useregarding non-clinical research, premarket clearance or marketing approval to clinical research, establishment registration, device listing, pre-market such Productnotification, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing reporting and reporting of other reports corrections and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Lawremovals. To the Knowledge of Parentthe Company, except as would not be material to the Company and its Subsidiaries, taken as a whole, any third Person that is a manufacturer or contractor for Parent the Company or any Affiliate of its Subsidiaries is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent the Company or any Affiliateof its Subsidiaries.
(c) With respect to As of the Business or the Productsdate hereof, there are no Actions Proceedings pending or or, to the Knowledge of the Company, threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental Authoritythat has jurisdiction over the operations of the Company and any of its Subsidiaries. Neither Parent As of the date hereof, neither the Company nor any of its Affiliates Subsidiaries has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, ,” notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any applicable Laws in relation or Registrations. Neither the Company nor any of its Subsidiaries is subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the Business FDA or any comparable Regulatory Authority. Each of the Products. Parent Company and all of its Affiliates have Subsidiaries has made all notifications, submissions, responses and reports as required by FDA Laws Laws, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any other applicable Law in relation to the Business comparable Regulatory Authority or the ProductsGovernmental Authority and all such notifications, which submissions, responses and reports were true true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parentthe Company, as of the date hereof, no basis for liability exists with respect to any such notificationsnotification, submissionssubmission, or reportsreport.
(d) Except as set forth in Section 3.11(c) No product distributed or sold by or on behalf of the Seller Disclosure ScheduleCompany or any of its Subsidiaries has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the Closing Datedate hereof, to the Knowledge of the Company, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (ii) a change in the labeling of any such product; or (iii) a termination, seizure, limitation, restriction, modification or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such product. As of the date hereof, no Product Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure or similar action of any such product are pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries. As of the date hereof, neither the Company nor any of its Subsidiaries has received any notice from a Regulatory Authority or other Governmental Authority that any product distributed or sold by or on behalf of the Company or any of its Subsidiaries cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental AuthorityCompany.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Subsidiaries have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical PracticesPractices requirements, other FDA Laws, applicable research protocols, institutional review board or other ethics committee requirementscorrective action plans, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Subsidiaries has been terminated, materially delayed, limited, limited or suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect , and neither the FDA nor any other applicable Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company or any of its Subsidiaries, has ordered or commenced, or, to the BusinessKnowledge of the Company, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw place a clinical hold order on, or otherwise terminate, materially delay, limit, modify or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company or any of its approval or request Subsidiaries, or, to the recall Knowledge of the Company, alleged any violation of any Product, (ii) commenced, or threatened to initiate, FDA Law in connection with any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packagedsuch clinical trial.
Appears in 1 contract
Sources: Merger Agreement (Stryker Corp)
FDA and Related Matters. (a) Parent and its Affiliates possess The Company has all Registrations required to conduct the Business as currently conducted, and Section 3.11(a3.27(a) of the Seller Disclosure Schedule of Exceptions sets forth a correct true and complete list as of the date of this Agreement of such Registrations. Each such Registration of the Registrations is valid and subsisting in full force and effect. To the Knowledge of Parentthe Company, (i) neither the FDA nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration Registrations or changing or challenging the marketing classification or labeling of the Products, products of the Company. The Company is in compliance in all material respects with all terms and there conditions of each Registration and all applicable reporting and other requirements for all Registrations. There is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are in compliance with and have The Company has fulfilled and performed in all material respects their respective its obligations under each such Registration, and, and to the Knowledge of Parentthe Company, no event has occurred or nor does any condition or state of facts exists exist which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Company, any third Person party that is a manufacturer or contractor for Parent or any of its Affiliates the Company is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent or any of its Affiliates, as applicablethe Company.
(b) All products developed, tested, investigated, manufactured, distributed, marketed, or sold by or on behalf of the Company that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, manufactured, distributed, marketed, and sold in compliance in all material respects with the FDCA, the Public Health Service Act, and any other applicable Law.
(c) There are no enforcement actions (including any administrative proceeding, data integrity review, prosecution, injunction, seizure, civil penalty, or debarment action) pending or, to the Knowledge of the Company, threatened by or on behalf of the FDA or any other Regulatory Authority that has jurisdiction over the operations of the Company, and to the Knowledge of the Company, no circumstances that would reasonably form the basis of any such action. The Company has never received any written notice from the FDA nor any comparable Regulatory Authority that remains unresolved (i) contesting the premarket clearance or approval of the uses of or the labeling and promotion of any Product or (ii) otherwise alleging any material violation of any Law applicable to the Products. The Company has previously provided to Parent true, correct and complete copies of (i) all such notices, and (ii) all correspondence between the Company and all Regulatory Authorities related thereto. Since January 1, 2012, the Company has not received any Form FDA-483, notice of adverse finding, FDA warning letters, notice of violation or “untitled letters,” notice of FDA action for import detentions or refusals, or any other notice from the FDA or other comparable Regulatory Authority alleging or asserting noncompliance with any applicable Laws or Registrations. The Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall or other field action, or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority. The Company has made all material notifications, submissions and reports required by the FDCA, the Public Health Service Act or any other applicable Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, recall or other field action or other notice, response, or commitment made to or with the FDA or any comparable Regulatory Authority and all such notifications, submissions and reports were true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority (or were corrected in or supplemented by a subsequent filing). To the Company’s Knowledge, no basis for liability exists with respect to any such notification, submission, or report.
(d) No Product has been subject to any seizure, withdrawal, recall or other field action, detention, or suspension of manufacturing since January 1, 2012, and to the Knowledge of the Company, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (ii) a change in the labeling of any such product; or (iii) a termination, seizure or suspension of the marketing or distribution (including for commercial, investigational, or any other use) of any such product. No proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such product are pending or, to the Knowledge of the Company, threatened against the Company.
(e) The Company has not initiated, conducted or sponsored any human clinical trials. The studies (including, without limitation, non-clinical laboratory studies), human clinical trials, tests and preclinical trials, if any, conducted by or on behalf of, or (if applicable) sponsored by, the Company to date (collectively, the “Studies”) were and, to the extent still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards and in accordance with all applicable Laws. The Company has not received any notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, or any institutional review board or ethics board, requiring or requesting the termination, suspension or material modification of any Study. No Studies have been otherwise terminated by the Company due to safety concerns. Nothing in the currently existing regulatory data, clinical data and other technical information (including, without limitation, any design history files, data and information) contained in and/or referenced by any Study submitted, or to be submitted, by the Company to a Governmental Entity, and any data bases incorporating any such data and information, related to the Company’s products (“Regulatory Data”) contain any untrue statement of a material fact or omit to state a material fact necessary in order to make the statements contained in such Regulatory Data not misleading.
(f) Neither the Company nor, to the Knowledge of the Company, any officer, employee or agent of the Company, has (i) been subject to any fine, injunction, civil penalty or other enforcement action by the FDA, or (ii) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Entity or in any records or documents prepared or maintained to comply with applicable Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Entity, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, could reasonably be expected to provide a basis for the FDA or any other Governmental Entity 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) or any similar policy.
(g) As to each Product product subject to the FDCA FDCA, or similar Law in any foreign jurisdiction jurisdiction, that is developed, manufactured, tested, distributed and/or marketed or investigated by or on behalf of the BusinessCompany (a “Medical Device”), each such Product Medical Device is being developed, manufactured, tested, investigated, distributed and/or and marketed by the Company in material compliance with all applicable requirements under the FDCA and similar Laws, including those relating to non-clinical research, clinical research, establishment registration, device listing, investigational use, premarket clearance or marketing approval to market such Producta Medical Device, post-market surveillance, good manufacturing practices, labeling, advertising, advertising and promotion, continuing medical education, record keeping, trainingproduct design and development, medical device reportingproduct sales and distribution, adverse event reportingMedical Device importation and exportation, filing of other reports and security, and in compliance with the Advanced Medical Technology Association Code of Ethics on Interactions with Healthcare Professionals and the American Medical Association’s guidelines on gifts to physicians, except for failures that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates The Company has not received any notice or other communication from the FDA or any other Governmental Authority Entity (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the BusinessCompany’s products, or (ii) otherwise alleging any material violation applicable to any such Product Medical Device of any applicable Law. To the Knowledge of Parent, any third Person that is a manufacturer or contractor for Parent or any Affiliate is in compliance with all FDA Laws or any other Law insofar as they pertain to the manufacture of Product components, accessories, parts or Products for Parent or any Affiliate.
(ch) With respect to the Business or the Products, there are no Actions pending or threatened in writing by or on behalf No article of the FDA or any other Regulatory Authority or Governmental Authority. Neither Parent nor any of its Affiliates has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any Laws in relation to the Business or any of the Products. Parent and all of its Affiliates have made all notifications, submissions, responses and reports as required by FDA Laws or any other applicable Law in relation to the Business or the Products, which were true and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parent, no basis for liability exists with respect to any such notifications, submissions, or reports.
(d) Except as set forth in Section 3.11(c) of the Seller Disclosure Schedule, as of the Closing Date, no Product developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of Parent or any of its Affiliates Medical Device is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental Authority.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical Practices, applicable research protocols, institutional review board or other ethics committee requirements, patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products has been terminated, materially delayed, limited, suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect to the Business, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, adulterated within the meaning of 21 U.S.C. § 351 (or threatened to initiate, any action to withdraw its approval or request the recall of any Productsimilar Law), (ii) commenced, misbranded within the meaning of 21 U.S.C. § 352 (or threatened to initiate, any action to enjoin production of any Productsimilar Law), or (iii) commenced, a product that is in violation of 21 U.S.C. § 360 or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested § 360e (or packagedsimilar Law).
Appears in 1 contract
Sources: Merger Agreement
FDA and Related Matters. (a) Parent and its Affiliates possess The Company possesses all Registrations required to conduct the its Business as currently conducted, and Section 3.11(a) of the Seller Disclosure Schedule sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parentthe Sellers, (i) as of the date hereof, neither the FDA United States Food and Drug Administration (the “FDAˮ) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending suspending, or revoking any such Registration or changing the marketing classification or labeling of the Products, and there Products of the Company. There is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are Except as set forth on Schedule 2.29(a), the Company is in compliance with with, and have has fulfilled and performed in all material respects their respective its obligations under under, each such Registration, and, to the Knowledge of Parentthe Sellers, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Sellers, any third Person that is a manufacturer or contractor for Parent or any of its Affiliates the Company is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products for Parent or any of its Affiliates, as applicablethe Company.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is All Products developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported, or exported by or on behalf of the Business, each such Product is Company that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported, and exported, as applicable, in all material respects, in compliance with all applicable requirements under FDA Laws, and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the FDCA and similar Lawsoperations of the Company, including those relating to investigational useregarding non-clinical research, premarket clearance or marketing approval to clinical research, establishment registration, device listing, pre-market such Productnotification, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing and reporting of other reports corrections and securityremovals. Except as set forth in Section 3.11(a) of the Seller Disclosure Scheduleon Schedule 2.29(b), none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Law. To the Knowledge of Parentthe Sellers, except as would not be material to the Company, taken as a whole, any third Person that is a manufacturer or contractor Contractor for Parent or any Affiliate the Company is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products for Parent or any Affiliatethe Company.
(c) With respect There are no Proceedings pending or, to the Business or Knowledge of the ProductsSellers, there are no Actions pending or threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental Authoritythat has jurisdiction over the operations of the Company. Neither Parent nor any of its Affiliates Except as set forth in Schedule 2.29(c), the Company has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, ,” notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any applicable Laws or Registrations. Except as set forth in relation Schedule 2.29(c), the Company is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response, or commitment made to or with the Business FDA, or any of the Productscomparable Regulatory Authority. Parent and all of its Affiliates have The Company has made all notifications, submissions, responses responses, and reports as required by FDA Laws Laws, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any other applicable Law in relation to the Business comparable Regulatory Authority or the ProductsGovernmental Authority and all such notifications, which submissions, responses, and reports were true true, complete, and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parent, no No basis for liability exists with respect to any such notificationsnotification, submissionssubmission, or reportsreport.
(d) Except as set forth in Section 3.11(c) of the Seller Disclosure Schedule, as of the Closing Dateon Schedule 2.29(d), no Product distributed or sold by or on behalf of the Company has been seized, withdrawn, recalled, detained, or subject to a suspension of manufacturing, and there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert, or suspension of manufacturing relating to any such Product; (ii) a change in the labeling of any such Product; or (iii) a termination, seizure, limitation, restriction, modification, or suspension of the marketing or distribution (including for commercial, investigational, or any other use) of any such Product. No Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure, or similar action of any such Product are pending or, to the Knowledge of the Sellers, threatened against the Company. The Company has not received any notice from a Regulatory Authority or other Governmental Authority that any Product distributed or sold by or on behalf of the Company or any of its Subsidiaries cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported imported, or exported substantially in the manner presently performed or contemplated by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental AuthorityCompany.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products Company have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical Practicesgood clinical practices requirements, other FDA Laws, applicable research protocols, institutional review board or other ethics committee requirementscorrective action plans, and federal and state laws, rules, and regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products Company has been terminated, materially delayed, limited, or suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect , and neither the FDA nor any other applicable Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company, has ordered or commenced, or, to the BusinessKnowledge of the Sellers, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw its approval place a clinical hold order on, or request otherwise terminate, materially delay, limit, modify, or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the recall Company, or, to the Knowledge of the Sellers, alleged any violation of any Product, (ii) commenced, or threatened to initiate, FDA Law in connection with any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packagedsuch clinical trial.
Appears in 1 contract
FDA and Related Matters. (a) Parent and its Affiliates possess Seller possesses all Registrations required to conduct the its Business as currently conducted, and Section 3.11(a) of the Seller Disclosure Schedule sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of ParentSeller, (i) as of the date hereof, neither the FDA United States Food and Drug Administration (the “FDAˮ) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the ProductsProducts of Seller. To the Knowledge of Seller, and there is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent and its Affiliates are Except as set forth on Schedule 2.27(a), Seller is in compliance with with, and have fulfilled and performed in all material respects their respective its obligations under under, each such Registration, and, as of the date hereof, to the Knowledge of ParentSeller, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of ParentSeller, any third Person that is a manufacturer or contractor for Parent or any of its Affiliates Seller is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products for Parent or any of its Affiliates, as applicableSeller.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is All Products developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported or exported by or on behalf of Seller that are subject to the Business, each such Product is jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects, in compliance with all applicable requirements under the FDCA and similar FDA Laws, including and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the operations of Seller, including, to the Knowledge of Seller, those relating to investigational useregarding non-clinical research, premarket clearance or marketing approval to clinical research, establishment registration, device listing, pre-market such Productnotification, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing reporting and reporting of other reports corrections and securityremovals. Except as set forth in Section 3.11(a) of the Seller Disclosure Scheduleon Schedule 2.27(b), none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Law. To the Knowledge of ParentSeller, except as would not be material to Seller, any third Person that is a manufacturer or contractor Contractor for Parent or any Affiliate Seller is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products for Parent or any AffiliateSeller.
(c) With respect to As of the Business or the Productsdate hereof, there are no Actions Proceedings pending or or, to the Knowledge of Seller, threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental Authoritythat has jurisdiction over the operations of Seller. Neither Parent nor any Except as set forth in Schedule 2.27(c), as of its Affiliates the date hereof, Seller has not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, ,” notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any applicable Laws or Registrations. Except as set forth in relation Schedule 2.27(c), Seller is not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the Business FDA or any of the Productscomparable Regulatory Authority. Parent and all of its Affiliates have Seller has made all notifications, submissions, responses and reports as required by FDA Laws Laws, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any other applicable Law in relation to the Business comparable Regulatory Authority or the ProductsGovernmental Authority and all such notifications, which submissions, responses and reports were true true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of ParentSeller, as of the date hereof, no basis for liability exists with respect to any such notificationsnotification, submissionssubmission, or reportsreport.
(d) Except as set forth in Section 3.11(c) on Schedule 2.27(d), no Product distributed or sold by or on behalf of the Seller Disclosure Schedulehas been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the Closing Datedate hereof, to the Knowledge of Seller, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such Product; (ii) a change in the labeling of any such Product; or (iii) a termination, seizure, limitation, restriction, modification or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such Product. As of the date hereof, no Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure or similar action of any such Product are pending or, to the Knowledge of Seller, threatened against Seller. As of the date hereof, Seller has not received any notice from a Regulatory Authority or other Governmental Authority that any Product distributed or sold by or on behalf of Seller or any of its Subsidiaries cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental AuthoritySeller.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products Seller have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical Practicesgood clinical practices requirements, other FDA Laws, applicable research protocols, institutional review board or other ethics committee requirementscorrective action plans, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of the Products Seller has been terminated, materially delayed, limited, limited or suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect , and neither the FDA nor any other applicable Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of Seller, has ordered or commenced, or, to the BusinessKnowledge of Seller, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw its approval place a clinical hold order on, or request otherwise terminate, materially delay, limit, modify or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of Seller, or, to the recall Knowledge of Seller, alleged any violation of any Product, (ii) commenced, or threatened to initiate, FDA Law in connection with any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packagedsuch clinical trial.
Appears in 1 contract
FDA and Related Matters. (a) Parent The Company and its Affiliates Subsidiaries possess all Registrations required to conduct the Business their respective businesses as currently conducted, and Section 3.11(a3.23(a) of the Seller Company Disclosure Schedule Letter sets forth a true, complete and correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parentthe Company, (i) as of the date hereof, neither the FDA United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Productsproducts of the Company and any of its Subsidiaries. To the Knowledge of the Company, and there is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent The Company and each of its Affiliates Subsidiaries are in compliance with with, and have fulfilled and performed in all material respects their respective obligations under under, each such Registration, and, as of the date hereof, to the Knowledge of Parentthe Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Company, any third Person that is a manufacturer or contractor for Parent the Company or any of its Affiliates Subsidiaries is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent the Company or any of its AffiliatesSubsidiaries, as applicable.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is All products developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported or exported by or on behalf of the Business, each such Product is Company or any of its Subsidiaries that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Authority have been and are being developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects in compliance with all FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Authority that has jurisdiction over the operations of the Company or any of its Subsidiaries, or any other applicable requirements under the FDCA and similar LawsLaw, including those relating to investigational useregarding non-clinical research, premarket clearance or marketing approval to clinical research, establishment registration, device listing, pre-market such Productnotification, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing reporting and reporting of other reports corrections and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Lawremovals. To the Knowledge of Parentthe Company, except as would not be material to the Company and its Subsidiaries, taken as a whole, any third Person that is a manufacturer or contractor for Parent the Company or any Affiliate of its Subsidiaries is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products products for Parent the Company or any Affiliateof its Subsidiaries.
(c) With respect There are no Proceedings pending or, to the Business or Knowledge of the ProductsCompany, there are no Actions pending or threatened in writing by or on behalf of the FDA or any other Regulatory Authority or Governmental AuthorityAuthority that has jurisdiction over the operations of the Company and any of its Subsidiaries. Neither Parent the Company nor any of its Affiliates Subsidiaries has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, ,” notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any applicable Laws in relation or Registrations. Neither the Company nor any of its Subsidiaries is subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the Business FDA or any comparable Regulatory Authority or Governmental Authority. Each of the Products. Parent Company and all of its Affiliates have Subsidiaries has made all notifications, submissions, responses and reports as required by FDA Laws or any other applicable Law in relation Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the Business FDA or the Productsany comparable Regulatory Authority or Governmental Authority and all such notifications, which submissions and reports were true true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parentthe Company, as of the date hereof, no basis for liability exists with respect to any such notificationsnotification, submissionssubmission, or reportsreport.
(d) Except as set forth in on Section 3.11(c3.23(d) of the Seller Company Disclosure ScheduleLetter, no product distributed or sold by or on behalf of the Company or any of its Subsidiaries has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the Closing Datedate hereof, there are no Product facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (ii) a change in the labeling of any such product; or (iii) a termination, seizure, limitation, restriction, modification or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such product. No Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure or similar action of any such product are pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any notice from a Regulatory Authority or other Governmental Authority that any product distributed or sold by or on behalf of the Company or any of its Subsidiaries cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental AuthorityCompany.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Subsidiaries have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical PracticesPractices requirements, other FDA Laws, applicable research protocols, institutional review board or other ethics committee requirementscorrective action plans, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Subsidiaries has been terminated, materially delayed, limited, limited or suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect , and neither the FDA nor any other applicable Governmental Authority or Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company or any of its Subsidiaries, has ordered or commenced, or, to the BusinessKnowledge of the Company, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw place a clinical hold order on, or otherwise terminate, materially delay, limit, modify or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the Company or any of its approval or request Subsidiaries, or, to the recall Knowledge of the Company, alleged any violation of any ProductFDA Law in connection with any such clinical trial.
(f) To the Knowledge of the Company, (ii) commenced, all data generated by the Company and any of its Subsidiaries with respect to their respective products that has been provided to their respective customers or threatened to initiate, any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product otherwise made public is manufactured, tested or packagedtruthful and not misleading.
Appears in 1 contract
FDA and Related Matters. (a) Parent The Company and its Affiliates the Subsidiary possess all Registrations required to conduct the their Business as currently conducted, and Section 3.11(a) of the Seller Disclosure Schedule sets forth a correct and complete list as of the date of this Agreement of such Registrations. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of Parentthe Company, (i) as of the date hereof, neither the FDA United States Food and Drug Administration (the “FDAˮ) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the ProductsProducts of the Company. To the Knowledge of the Company and the Subsidiary, and there is no false or misleading information or material omission in any Product product application or other submission, notification or report submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Parent The Company and its Affiliates the Subsidiary are in compliance with with, and have fulfilled and performed in all material respects their respective obligations under under, each such Registration, and, as of the date hereof, to the Knowledge of Parentthe Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of Parentthe Company, any third Person that is a manufacturer or contractor for Parent or any of its Affiliates the Company and the Subsidiary is in compliance with all Registrations insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products for Parent the Company or any of its Affiliates, as applicablethe Subsidiary.
(b) As to each Product subject to the FDCA or similar Law in any foreign jurisdiction that is All Products developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported or exported by or on behalf of the Business, each such Product is Company and the Subsidiary that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, testedlabeled, distributed and/or marketed distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects, in compliance with all applicable requirements under FDA Laws, and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the FDCA operations of the Company and similar Lawsthe Subsidiary, including those relating to investigational useregarding non-clinical research, premarket clearance or marketing approval to clinical research, establishment registration, device listing, pre-market such Productnotification, good manufacturing practices, labeling, advertising, promotion, continuing medical education, record record-keeping, training, medical device reportingimportation and exportation, adverse event reporting, filing reporting and reporting of other reports corrections and security. Except as set forth in Section 3.11(a) of the Seller Disclosure Schedule, none of Parent or its Affiliates has received any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, the uses of or the labeling and promotion of any products of the Business, or (ii) otherwise alleging any material violation applicable to any such Product of any Lawremovals. To the Knowledge of Parentthe Company and the Subsidiary, except as would not be material to the Company, taken as a whole, any third Person that is a manufacturer or contractor Contractor for Parent or any Affiliate the Company and the Subsidiary is in compliance with all FDA Laws or any other applicable Law insofar as they pertain to the manufacture of Product components, accessories, parts product components or Products for Parent or any Affiliatethe Company.
(c) With respect to As of the Business or the Productsdate hereof, there are no Actions Proceedings pending or or, to the Knowledge of the Company, threatened in writing by or on behalf of the FDA or any other Regulatory Authority that has jurisdiction over the operations of the Company or Governmental Authoritythe Subsidiary. Neither Parent As of the date hereof, neither the Company nor any of its Affiliates the Subsidiary has received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter”, ,” notice of FDA action for import detention or refusal, or any other notice of an adverse action from the FDA or any other Regulatory Authority or Governmental Authority alleging or asserting noncompliance with any applicable Laws in relation or Registrations. The Company and the Subsidiary are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the Business FDA or any of comparable Regulatory Authority. The Company and the Products. Parent and all of its Affiliates Subsidiary have made all notifications, submissions, responses and reports as required by FDA Laws Laws, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any other applicable Law in relation to the Business comparable Regulatory Authority or the ProductsGovernmental Authority and all such notifications, which submissions, responses and reports were true true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of Parentthe Company, as of the date hereof, no basis for liability exists with respect to any such notificationsnotification, submissionssubmission, or reportsreport.
(d) Except as set forth in Section 3.11(c) No Product distributed or sold by or on behalf of the Seller Disclosure ScheduleCompany or the Subsidiary has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the Closing Datedate hereof, to the Knowledge of the Company, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such Product; (ii) a change in the labeling of any such Product; or (iii) a termination, seizure, limitation, restriction, modification or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such Product. As of the date hereof, no Proceedings in the United States or any other jurisdiction seeking the withdrawal, recall, correction, suspension, import detention, seizure or similar action of any such Product are pending or, to the Knowledge of the Company, threatened against the Company or the Subsidiary. As of the date hereof, neither the Company nor the Subsidiary has received any notice from a Regulatory Authority or other Governmental Authority that any Product distributed or sold by or on behalf of the Company or the Subsidiary cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of Parent or any of its Affiliates is under consideration for recall, withdrawal, suspension, seizure or discontinuance; or has been recalled, seized, withdrawn, or detained; or subject to a suspension of manufacturing, voluntary or involuntary corrective action, advisory notice, safety alert, or discontinued, or subject to any other administrative, regulatory, enforcement, or adverse action with respect to Products the Company or the Business by a Regulatory Authority or Governmental Authority, pending or threatened in writing in the United States or outside the United States (whether voluntarily or otherwise). With respect to the Products and the Business, there are no facts or circumstances reasonably likely to cause an administrative, regulatory, enforcement, or any other adverse action by the FDA or similar Regulatory Authority or Governmental AuthoritySubsidiary.
(e) All preclinical and clinical investigations sponsored or conducted by or on behalf of Parent or any of its Affiliates relating to the Business or any of Company and the Products Subsidiary have been and are being conducted in material compliance with all applicable Laws and other requirements, including Good Clinical Practicesgood clinical practices requirements, other FDA Laws, applicable research protocols, institutional review board or other ethics committee requirementscorrective action plans, and federal and state laws, rules, regulations relating to patient privacy requirements or restricting the use and disclosure of individually identifiable health information. No clinical trial sponsored or conducted by or on behalf of Parent the Company or any of its Affiliates relating to the Business or any of the Products Subsidiary has been terminated, materially delayed, limited, limited or suspended or placed on clinical hold prior to completion by the FDA, any other applicable Governmental Authority or Regulatory Authority, or any institutional review board or other ethics committee that has or has had jurisdiction over such clinical trial.
(f) With respect , and neither the FDA nor any other applicable Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company or the Subsidiary, has ordered or commenced, or, to the BusinessKnowledge of the Company, since January 1, 2017, none of Parent or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw its approval place a clinical hold order on, or request otherwise terminate, materially delay, limit, modify or suspend, any proposed or ongoing clinical trial conducted or proposed to be conducted by or on behalf of the recall Company or the Subsidiary, or, to the Knowledge of the Company, alleged any violation of any Product, (ii) commenced, or threatened to initiate, FDA Law in connection with any action to enjoin production of any Product, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Product is manufactured, tested or packagedsuch clinical trial.
Appears in 1 contract