FDA Matters. (a) All Drug Authorizations are current and in full force and effect, have been duly and validly issued, contain no material error or omission, and are owned exclusively by Bioglan. All regulatory approvals or authorizations owned by Sellers and relating to the Products are set forth on Section 2.1(a)(i) of the Disclosure Letter. Sellers have complied in all material respects with their respective obligations to report adverse drug experiences and are in compliance in all material respects with all other obligations applicable to the Products pursuant to the FFDCA and other applicable Legal Requirements. There is no Proceeding pending or, to the Knowledge of Sellers, threatened seeking the recall of any Products or the revocation or suspension of any Drug Authorization. Sellers have made available to Buyer true and correct copies of all Drug Authorizations, and there are no material changes, amendments or other circumstances in connection with or relating to any of the Products that would require the filing of any material amendment or supplement to a Drug Authorization or the filing of any new Drug Authorization. (b) To Sellers’ Knowledge, the ANDA relating to Adoxa® is current and in full force and effect, has been duly and validly issued and contains no material error or omission. To Sellers’ Knowledge, there is no Proceeding pending or threatened seeking the recall of Adoxa® or the revocation or suspension of the ANDA relating to Adoxa®. To Sellers’ Knowledge, there are no material changes, amendments or other circumstances in connection with or relating to Adoxa® that would require the filing of any material amendment or supplement to the ANDA relating to Adoxa®. (c) Except as set forth in Section 3.17(c) of the Disclosure Letter, Sellers have not received or been subject to: (i) any FDA Form 483’s concerning the Products; (ii) any FDA Notices of Adverse Findings concerning the Products; or (iii) warning letters or other correspondence from the FDA or any other Governmental Body concerning (1) the Products in which the FDA or other such Governmental Body asserted that the operations of any Seller or the Products were not in compliance with applicable Legal Requirements in any material respect, (2) issues arising from any pricing issues concerning the Products, including “best pricing” issues and Medicaid rebates,
Appears in 1 contract
Samples: Asset Purchase Agreement (Bradley Pharmaceuticals Inc)
FDA Matters. (a) All Drug Authorizations are current and in full force and effect, have been duly and validly issued, contain no material error or omission, and are owned exclusively by Bioglan. All regulatory approvals or authorizations owned by Sellers and relating to the Products are set forth on Section 2.1(a)(i) of the Disclosure Letter. Sellers have complied in all material respects with their respective obligations to report adverse drug experiences and are in compliance in all material respects with all other obligations applicable to the Products pursuant to the FFDCA and other applicable Legal Requirements. There is no Proceeding pending or, to the Knowledge of Sellers, threatened seeking the recall of any Products or the revocation or suspension of any Drug Authorization. Sellers have made available to Buyer true and correct copies of all Drug Authorizations, and there are no material changes, amendments or other circumstances in connection with or relating to any of the Products that would require the filing of any material amendment or supplement to a Drug Authorization or the filing of any new Drug Authorization.
(b) To Sellers’ ' Knowledge, the ANDA relating to Adoxa® Adoxa(R) is current and in full force and effect, has been duly and validly issued and contains no material error or omission. To Sellers’ ' Knowledge, there is no Proceeding pending or threatened seeking the recall of Adoxa® Adoxa(R) or the revocation or suspension of the ANDA relating to Adoxa®Adoxa(R). To Sellers’ ' Knowledge, there are no material changes, amendments or other circumstances in connection with or relating to Adoxa® Adoxa(R) that would require the filing of any material amendment or supplement to the ANDA relating to Adoxa®Adoxa(R).
(c) Except as set forth in Section 3.17(c) of the Disclosure Letter, Sellers have not received or been subject to: (i) any FDA Form 483’s 's concerning the Products; (ii) any FDA Notices of Adverse Findings concerning the Products; or (iii) warning letters or other correspondence from the FDA or any other Governmental Body concerning (1) the Products in which the FDA or other such Governmental Body asserted that the operations of any Seller or the Products were not in compliance with applicable Legal Requirements in any material respect, (2) issues arising from any pricing issues concerning the Products, including “"best pricing” " issues and Medicaid rebates,, (3) issues concerning the Products involving financial relationships between any Seller and any health care provider or pharmacy, including issues of improper payments, kickbacks, promotional activities, speakers' fees or continuing medical education; or (4) any other issues in relation to the Product, including but not limited to marketing and promotional activities and off-label promotion of a Product. During Sellers' ownership or license of the Products and, to the Sellers' Knowledge, prior thereto, there have been no recalls involving the Products. Except as set forth on Section 3.17(c) of the Disclosure Letter, there is no pending or, to the Knowledge of Sellers, threatened material Proceeding relating to safety or efficacy of any of the Products.
(d) As to any product in development by Sellers and not the subject of a Drug Authorization, Sellers are in compliance in all material respects with all applicable Legal Requirements in connection with the development and clinical testing of such product in the United States.
(e) Sellers have not marketed, distributed or sold any of the Products outside the United States.
Appears in 1 contract
Samples: Asset Purchase Agreement (Quintiles Transnational Corp)
FDA Matters. (a) All Drug Authorizations are current During the period beginning on the date hereof and in full force and effectending on the Closing Date, have been duly and validly issuedSeller shall take, contain no material error or omissioncause to be taken, all actions, and are owned exclusively by Bioglan. All regulatory approvals to do, or authorizations owned by Sellers cause to be done, all activities reasonably necessary to (i) initiate and relating continue the remediation of all outstanding FDA observations and findings with respect to the Products are set forth Company’s regulatory compliance, consistent with the Company’s operating plan for fiscal year 2010 (based on Section 2.1(a)(ithe April 2010 version of such plan) as it relates to remediation actions, (ii) promptly address all new FDA observations or findings in the event of an FDA communication with, audit of or inspection of the Disclosure Letter. Sellers have complied Company, (iii) cooperate with the FDA in all material respects with their respective obligations the event of any threatened enforcement Action against the Company and address promptly any matters identified by the FDA to report adverse drug experiences cause such enforcement Action not to be initiated, (iv) if an FDA enforcement Action is initiated against the Company, take prompt action to remediate any new or outstanding FDA observations and are in compliance in all material respects with all other obligations applicable findings and seek withdrawal or mitigation of any such Action, (v) provide prompt notice to Buyer as to any threatened or initiated enforcement Action against the Company, including information as to the Products pursuant to the FFDCA scope and other applicable Legal Requirements. There is no Proceeding pending or, to the Knowledge nature of Sellers, threatened seeking the recall of such Action and any Products or the revocation or suspension of any Drug Authorization. Sellers have made available to Buyer true and correct copies of all Drug Authorizationsplanned response, and there are no material changes, amendments or other circumstances (vi) reasonably consider any proposals made by Buyer in connection with or relating any such matters. On a weekly basis, Seller shall provide updates to Buyer on the status of all such remediation efforts, including with respect to any of meetings or other communications with the Products that would require FDA. Any costs or expenses incurred by the filing of any material amendment or supplement to a Drug Authorization or the filing of any new Drug AuthorizationCompany in connection with complying with this Section 6.15 shall be borne by Seller.
(b) To Sellers’ KnowledgeFrom and after the Closing until the date that is three (3) years from the Closing Date, the ANDA relating to Adoxa® is current and in full force and effect, has been duly and validly issued and contains no material error or omission. To Sellers’ Knowledge, there is no Proceeding pending or threatened seeking the recall of Adoxa® or the revocation or suspension of the ANDA relating to Adoxa®. To Sellers’ Knowledge, there are no material changes, amendments or other circumstances in connection with any Losses arising out of or relating resulting from (directly or indirectly) the Known FDA Matters, Seller shall be responsible for (and shall pay) eighty percent (80%) of all such Losses and Buyer shall be responsible for (and shall pay) twenty percent (20%) of all such Losses; provided, however, that (i) the foregoing covenant (the “FDA Cost-Sharing Covenant”) shall only apply once the aggregate amount of Losses arising out of or resulting from (directly or indirectly) the Known FDA Matters exceeds $2,000,000 (and Buyer shall be solely responsible for such first $2,000,000), and (ii) the aggregate amount required to Adoxa® that would require the filing of any material amendment or supplement be paid by Seller pursuant to the ANDA relating FDA Cost-Sharing Covenant shall not exceed an amount equal to Adoxa®.
$25,000,000 (cwhich, for purposes of calculating this amount, (x) Except as includes all amounts paid by Seller pursuant to its indemnification obligations under Section 9.2(a)(i) hereof which are subject to the limitations set forth in Section 3.17(c9.3(a)(ii), (y) excludes the $2,000,000 threshold amount described in the foregoing clause (i), and (z) excludes the twenty percent (20%) of the Disclosure Letter, Sellers have amount of Losses that are not received or been subject to: (i) any FDA Form 483’s concerning the Products; (ii) any FDA Notices of Adverse Findings concerning the Products; or (iii) warning letters or other correspondence from required to be paid by Seller pursuant to the FDA or any other Governmental Body concerning (1) the Products in which the FDA or other such Governmental Body asserted that the operations of any Seller or the Products were not in compliance with applicable Legal Requirements in any material respect, (2) issues arising from any pricing issues concerning the Products, including “best pricing” issues and Medicaid rebates,Cost-Sharing Covenant).
Appears in 1 contract
FDA Matters. (a) All Drug Authorizations are current Holdings and in full force and effect, have been duly and validly issued, contain no material error or omissioneach of its Subsidiaries is, and are owned exclusively the products sold by Bioglan. All regulatory approvals or authorizations owned by Sellers Holdings and relating to the Products are set forth on Section 2.1(a)(i) each of the Disclosure Letter. Sellers have complied its Subsidiaries are, in compliance in all material respects with their respective obligations all current applicable statutes, rules, regulations, standards, guides, policies or orders administered or issued by the FDA.
(b) Neither Holdings nor any of its Subsidiaries has received, or has knowledge of any facts which furnish any reasonable basis for, any Notice of Adverse Findings, Warning Letters, Regulatory Letters, Section 305 Notices, or other similar communications, and there have been no recalls, field notifications, alerts or seizures requested or threatened relating to report adverse drug experiences the products sold by Borrower and each of its Subsidiaries.
(c) The premarket approval ("PMA") and premarket notification ("510(k)") documents and related documents and information for each of the products of Holdings and each of its Subsidiaries are in compliance in all material respects with the applicable federal statutes, rules, regulations, standards, guides, policies or orders administered or promulgated by the FDA and Holdings has no reason to believe that the FDA is considering limiting, suspending or revoking any such approvals or clearances. All preclinical and clinical studies have been conducted with recognized good clinical and good laboratory practices in all other obligations applicable to the Products pursuant to the FFDCA and other applicable Legal Requirements. There material respects.
(d) Neither Holdings nor any of its Subsidiaries is no Proceeding pending or, to the Knowledge of Sellers, threatened seeking the recall aware of any Products or facts which are reasonably likely to cause (i) the revocation denial, withdrawal, recall or suspension of any Drug Authorization. Sellers have made available product sold or intended to Buyer true and correct copies of all Drug Authorizations, and there are no material changes, amendments be sold by Holdings or other circumstances in connection with or relating to any of the Products that would require the filing of any material amendment its Subsidiaries, or supplement to a Drug Authorization or the filing of any new Drug Authorization.
(b) To Sellers’ Knowledge, the ANDA relating to Adoxa® is current and in full force and effect, has been duly and validly issued and contains no material error or omission. To Sellers’ Knowledge, there is no Proceeding pending or threatened seeking the recall of Adoxa® or the revocation or suspension of the ANDA relating to Adoxa®. To Sellers’ Knowledge, there are no material changes, amendments or other circumstances in connection with or relating to Adoxa® that would require the filing of any material amendment or supplement to the ANDA relating to Adoxa®.
(c) Except as set forth in Section 3.17(c) of the Disclosure Letter, Sellers have not received or been subject to: (i) any FDA Form 483’s concerning the Products; (ii) a change in the marketing classification or labeling of any FDA Notices of Adverse Findings concerning the Products; such products, or (iii) warning letters a termination or other correspondence suspension of marketing of any such products.
(e) Annex IX hereto contains an accurate and complete list of (i) all products currently manufactured, marketed or sold by Holdings and each of its Subsidiaries which have been recalled or subject to a field notification (whether voluntarily or otherwise); and (ii) all proceedings of which Holdings or any of its Subsidiaries has received notice (whether completed or pending) at any time seeking recall, suspension or seizure of any product sold or proposed to be sold by Holdings or any of its Subsidiaries.
(f) Holdings has conducted all internal audits, has prepared all internal audit reports, has conducted all management reviews of such audit reports and has taken all such follow up corrective action indicated by such audit reports as are required by 21 C.F.R. Section 820.20.
(g) Holdings and each of its Subsidiaries has timely filed all medical device reports (the "Medical Device Report Policy") required to be filed by 21 C.F.R. Section 803.24. Annex X hereto sets forth Holdings' and each of its Subsidiary's corporate policy for filing such reports.
(h) Holdings has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by Holdings or any of its Subsidiaries.
(i) Holdings reasonably believes that it will be able to obtain authorization from the FDA or any other Governmental Body concerning (1to market all products proposed as of the Initial Borrowing Date to be introduced by it under a 510(k) the Products in which clearance, and will not be required to file a PMA application with the FDA or other with respect to any such Governmental Body asserted that the operations of any Seller or the Products were not in compliance with applicable Legal Requirements in any material respect, (2) issues arising from any pricing issues concerning the Products, including “best pricing” issues and Medicaid rebates,products.
Appears in 1 contract
FDA Matters. (a) All Drug Authorizations are current and in full force and effect, have been duly and validly issued, contain no material error or omissionThe Borrower shall, and are owned exclusively shall cause each of its Subsidiaries to, and shall ensure that the products sold by Bioglan. All regulatory approvals the Borrower or authorizations owned by Sellers and relating to the Products are set forth on Section 2.1(a)(i) of the Disclosure Letter. Sellers have complied in all material respects with their respective obligations to report adverse drug experiences and are in compliance such Subsidiaries, comply in all material respects with all other obligations applicable to current Requirements of Law issued or administered by the Products pursuant to the FFDCA and other applicable Legal Requirements. There is no Proceeding pending or, to the Knowledge of Sellers, threatened seeking the recall of any Products or the revocation or suspension of any Drug Authorization. Sellers have made available to Buyer true and correct copies of all Drug Authorizations, and there are no material changes, amendments or other circumstances in connection with or relating to any of the Products that would require the filing of any material amendment or supplement to a Drug Authorization or the filing of any new Drug AuthorizationFDA.
(b) To Sellers’ KnowledgeNeither the Borrower nor any of its Subsidiaries has received, the ANDA or has knowledge of any facts which furnish any reasonable basis for, any Notice of Adverse Findings, Warning Letters, Regulatory Letters, Section 305 Notices, or other similar communications, and since April 1, 2001, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to Adoxa® is current and in full force and effect, has been duly and validly issued and contains no material error the products sold by Borrower or omission. To Sellers’ Knowledge, there is no Proceeding pending or threatened seeking the recall any of Adoxa® or the revocation or suspension of the ANDA relating to Adoxa®. To Sellers’ Knowledge, there are no material changes, amendments or other circumstances in connection with or relating to Adoxa® that would require the filing of any material amendment or supplement to the ANDA relating to Adoxa®its Subsidiaries.
(c) Except as set forth in Section 3.17(cThe premarket approval (“PMA”) and premarket notification (“510(k)”) documents and related documents and information for each of the Disclosure Letterproducts of the Borrower and each of its Subsidiaries comply in all material respects with the applicable Requirements of Law administered or promulgated by the FDA and the Borrower has no reason to believe that the FDA is considering limiting, Sellers suspending or revoking any such approvals or clearances. All preclinical and clinical studies have not received been conducted with recognized good clinical and good laboratory practices in all material respects.
(d) Neither the Borrower nor any of its Subsidiaries is aware of any facts or been subject to: circumstances which are reasonably likely to cause (i) the denial, withdrawal, recall or suspension of any FDA Form 483’s concerning product sold or intended to be sold by the Products; Borrower or any of its Subsidiaries, or (ii) a change in the marketing classification or labeling of any FDA Notices of Adverse Findings concerning the Products; such products, or (iii) warning letters a termination or other correspondence suspension of marketing of any such products.
(e) Set forth on Schedule 4.21 (FDA Matters) is a complete and accurate list, as of the date hereof, of (i) all products manufactured, marketed or sold by the Borrower and each of its Subsidiaries which have been recalled or subject to a field notification (whether voluntarily or otherwise) on or after April 1, 2001 and (ii) all proceedings commenced on or after April 1, 2001 of which the Borrower or any of its Subsidiaries has received notice (whether completed or pending) at any time seeking recall, suspension or seizure of any product sold or proposed to be sold by the Borrower or any of its Subsidiaries.
(f) Since April 1, 2001, the Borrower has conducted all internal audits, has prepared all internal audit reports, has conducted all management reviews of such audit reports and has taken all such follow up corrective action indicated by such audit reports as are required pursuant to 21 C.F.R. Section 820.20.
(g) Since April 1, 2001, the Borrower and each of its Subsidiaries has timely filed all medical device reports (the “Medical Device Report Policy”) required to be filed pursuant to 21 C.F.R. Section 802.24. Schedule 4.21 (FDA Matters) hereto sets forth each of the Borrower’s and each of its Subsidiary’s corporate policy for filing such reports.
(h) The Borrower has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by it or any of its Subsidiaries.
(i) The Borrower reasonably believes that it will be able to obtain authorization from the FDA or any other Governmental Body concerning (1to market all products proposed as of the Closing Date to be introduced by it under a 510(k) the Products in which clearance, and will not be required to file a PMA application with the FDA or other with respect to any such Governmental Body asserted that the operations of any Seller or the Products were not in compliance with applicable Legal Requirements in any material respect, (2) issues arising from any pricing issues concerning the Products, including “best pricing” issues and Medicaid rebates,products.
Appears in 1 contract
