Common use of FDA Matters Clause in Contracts

FDA Matters. (a) The Borrower shall, and shall cause each of its Subsidiaries to, and shall ensure that the products sold by the Borrower or such Subsidiaries, comply in all material respects with all current Requirements of Law issued or administered by the FDA. (b) Neither the Borrower 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 since April 1, 2001, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the products sold by Borrower or any 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 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, 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 material respects. (d) Neither the Borrower nor any of its Subsidiaries is aware of any facts or circumstances which are reasonably likely to cause (i) the denial, withdrawal, recall or suspension of any product sold or intended to be sold by the Borrower or any of its Subsidiaries, or (ii) a change in the marketing classification or labeling of any such products, or (iii) a termination or 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 to market all products proposed as of the Closing Date to be introduced by it under a 510(k) clearance, and will not be required to file a PMA application with the FDA with respect to any such products.

FDA Matters. (a) The Borrower shall, Holdings and shall cause each of its Subsidiaries tois, and shall ensure that the products sold by the Borrower or such SubsidiariesHoldings and each of its Subsidiaries are, comply in compliance in all material respects with all current Requirements of Law applicable statutes, rules, regulations, standards, guides, policies or orders administered or issued or administered by the FDA. (b) Neither the Borrower 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 since April 1, 2001, there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the products sold by Borrower or any 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 the Borrower Holdings and each of its Subsidiaries comply are in compliance in all material respects with the applicable Requirements of Law federal statutes, rules, regulations, standards, guides, policies or orders administered or promulgated by the FDA and the Borrower 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 material respects. (d) Neither the Borrower Holdings nor any of its Subsidiaries is aware of any facts or circumstances which are reasonably likely to cause (i) the denial, withdrawal, recall or suspension of any product sold or intended to be sold by the Borrower Holdings or any of its Subsidiaries, or (ii) a change in the marketing classification or labeling of any such products, or (iii) a termination or suspension of marketing of any such products. (e) Set forth on Schedule 4.21 (FDA Matters) is a Annex IX hereto contains an accurate and complete and accurate list, as of the date hereof, list of (i) all products currently manufactured, marketed or sold by the Borrower Holdings 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 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 the Borrower Holdings or any of its Subsidiaries. (f) Since April 1, 2001, the Borrower 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 pursuant to by 21 C.F.R. Section 820.20. (g) Since April 1, 2001, the Borrower Holdings and each of its Subsidiaries has timely filed all medical device reports (the “"Medical Device Report Policy”") required to be filed pursuant to by 21 C.F.R. Section 802.24803.24. Schedule 4.21 (FDA Matters) Annex X hereto sets forth each of the Borrower’s Holdings' and each of its Subsidiary’s 's corporate policy for filing such reports. (h) The Borrower Holdings has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by it Holdings or any of its Subsidiaries. (i) The Borrower Holdings reasonably believes that it will be able to obtain authorization from the FDA to market all products proposed as of the Closing Initial Borrowing Date to be introduced by it under a 510(k) clearance, and will not be required to file a PMA application with the FDA with respect to any such products.

FDA Matters. (a) The Borrower shallAll Drug Authorizations are current and in full force and effect, have been duly and validly issued, contain no material error or omission, and shall cause each 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 its Subsidiaries to, the Disclosure Letter. Sellers have complied in all material respects with their respective obligations to report adverse drug experiences and shall ensure that the products sold by the Borrower or such Subsidiaries, comply are in compliance in all material respects with all current Requirements 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 Law issued Sellers, threatened seeking the recall of any Products or administered by the FDArevocation 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) Neither To Sellers' Knowledge, the Borrower nor any ANDA relating to 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 its Subsidiaries has receivedAdoxa(R) or the revocation or suspension of the ANDA relating to Adoxa(R). To Sellers' Knowledge, there are no material changes, amendments or has knowledge other circumstances in connection with or relating to Adoxa(R) that would require the filing of any facts which furnish material amendment or supplement to the ANDA relating to 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 reasonable basis for, FDA Form 483's concerning the Products; (ii) any Notice FDA Notices of Adverse Findings, Warning Letters, Regulatory Letters, Section 305 Notices, Findings concerning the Products; or (iii) warning letters or other similar communicationscorrespondence 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 since April 1Medicaid rebates, 2001(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 recallsrecalls involving the Products. Except as set forth on Section 3.17(c) of the Disclosure Letter, field notificationsthere is no pending or, alerts or seizures requested or to the Knowledge of Sellers, threatened material Proceeding relating to the products sold by Borrower safety or efficacy of any of its Subsidiariesthe Products. (cd) The premarket approval (“PMA”) As to any product in development by Sellers and premarket notification (“510(k)”) documents and related documents and information for each not the subject of the products of the Borrower and each of its Subsidiaries comply a Drug Authorization, Sellers are in compliance in all material respects with all applicable Legal Requirements in connection 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, suspending or revoking any such approvals or clearances. All preclinical development and clinical studies have been conducted with recognized good clinical and good laboratory practices in all material respects. (d) Neither the Borrower nor any testing of its Subsidiaries is aware of any facts or circumstances which are reasonably likely to cause (i) the denial, withdrawal, recall or suspension of any such product sold or intended to be sold by the Borrower or any of its Subsidiaries, or (ii) a change in the marketing classification or labeling of any such products, or (iii) a termination or suspension of marketing of any such productsUnited States. (e) Set forth on Schedule 4.21 (FDA Matters) is a complete and accurate listSellers have not marketed, as distributed or sold any of the date hereof, of (i) all products manufactured, marketed or sold by Products outside 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 SubsidiariesUnited States. (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 to market all products proposed as of the Closing Date to be introduced by it under a 510(k) clearance, and will not be required to file a PMA application with the FDA with respect to any such products.

FDA Matters. (a) The Borrower shallAll Drug Authorizations are current and in full force and effect, have been duly and validly issued, contain no material error or omission, and shall cause each 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 its Subsidiaries to, the Disclosure Letter. Sellers have complied in all material respects with their respective obligations to report adverse drug experiences and shall ensure that the products sold by the Borrower or such Subsidiaries, comply are in compliance in all material respects with all current Requirements 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 Law issued Sellers, threatened seeking the recall of any Products or administered by the FDArevocation 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) Neither To Sellers’ Knowledge, the Borrower nor any 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 its Subsidiaries has receivedAdoxa® or the revocation or suspension of the ANDA relating to Adoxa®. To Sellers’ Knowledge, there are no material changes, amendments or has knowledge other circumstances in connection with or relating to Adoxa® that would require the filing of any facts which furnish any reasonable basis for, any Notice of Adverse Findings, Warning Letters, Regulatory Letters, Section 305 Notices, material amendment or other similar communications, and since April 1, 2001, there have been no recalls, field notifications, alerts or seizures requested or threatened supplement to the ANDA relating to the products sold by Borrower or any of its SubsidiariesAdoxa®. (c) The premarket approval (“PMA”Except as set forth in Section 3.17(c) and premarket notification (“510(k)”) documents and related documents and information for each of the products of the Borrower and each of its Subsidiaries comply in all material respects with the applicable Requirements of Law administered Disclosure Letter, Sellers have not received or promulgated by the FDA and the Borrower 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 material respects. (d) Neither the Borrower nor any of its Subsidiaries is aware of any facts or circumstances which are reasonably likely to cause subject to: (i) any FDA Form 483’s concerning the denial, withdrawal, recall or suspension of any product sold or intended to be sold by the Borrower or any of its Subsidiaries, or Products; (ii) a change in any FDA Notices of Adverse Findings concerning the marketing classification or labeling of any such products, Products; or (iii) a termination warning letters or 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 other correspondence from the FDA to market all products proposed as of or any other Governmental Body concerning (1) the Closing Date to be introduced by it under a 510(k) clearance, and will not be required to file a PMA application with 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 respect to applicable Legal Requirements in any such products.material respect, (2) issues arising from any pricing issues concerning the Products, including “best pricing” issues and Medicaid rebates,

FDA Matters. (a) The Borrower shallDuring the period beginning on the date hereof and ending on the Closing Date, Seller shall take, or cause to be taken, all actions, and shall to do, or cause each to be done, all activities reasonably necessary to (i) initiate and continue the remediation of its Subsidiaries toall outstanding FDA observations and findings with respect to the Company’s regulatory compliance, consistent with the Company’s operating plan for fiscal year 2010 (based on the 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 Company, (iii) cooperate with the FDA in the event of any threatened enforcement Action against the Company and address promptly any matters identified by the FDA to 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 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 scope and nature of such Action and any planned response, and (vi) reasonably consider any proposals made by Buyer in connection with any such matters. On a weekly basis, Seller shall ensure that provide updates to Buyer on the products sold status of all such remediation efforts, including with respect to any meetings or other communications with the FDA. Any costs or expenses incurred by the Borrower or such Subsidiaries, comply Company in all material respects connection with all current Requirements of Law issued or administered complying with this Section 6.15 shall be borne by the FDASeller. (b) Neither From and after the Borrower nor Closing until the date that is three (3) years from the Closing Date, in connection with any Losses arising out of its Subsidiaries has receivedor resulting from (directly or indirectly) the Known FDA Matters, or has knowledge Seller shall be responsible for (and shall pay) eighty percent (80%) of any facts which furnish any reasonable basis forall such Losses and Buyer shall be responsible for (and shall pay) twenty percent (20%) of all such Losses; provided, any Notice of Adverse Findingshowever, 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 the products sold by Borrower or any 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 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, 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 material respects. (d) Neither the Borrower nor any of its Subsidiaries is aware of any facts or circumstances which are reasonably likely to cause (i) the denialforegoing 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), withdrawal, recall or suspension of any product sold or intended to be sold by the Borrower or any of its Subsidiaries, or (ii) a change in the marketing classification or labeling of any such products, or (iii) a termination or 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”) aggregate amount required to be filed paid by Seller pursuant to 21 C.F.R. the FDA Cost-Sharing Covenant shall not exceed an amount equal to $25,000,000 (which, for purposes of calculating this amount, (x) includes all amounts paid by Seller pursuant to its indemnification obligations under Section 802.24. Schedule 4.21 9.2(a)(i) hereof which are subject to the limitations set forth in Section 9.3(a)(ii), (FDA Mattersy) hereto sets forth each excludes the $2,000,000 threshold amount described in the foregoing clause (i), and (z) excludes the twenty percent (20%) of the Borrower’s and each amount 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 Losses that are not required to be paid by Seller pursuant to the products distributed and sold by it or any of its SubsidiariesFDA Cost-Sharing Covenant). (i) The Borrower reasonably believes that it will be able to obtain authorization from the FDA to market all products proposed as of the Closing Date to be introduced by it under a 510(k) clearance, and will not be required to file a PMA application with the FDA with respect to any such products.

FDA Matters. (a) The Borrower shallAll Registrations held by Forest are set forth in Schedule 3.11(a) of the Forest Disclosure Schedule. Other than as set forth on Schedule 3.11(a) of the Forest Disclosure Schedule: (i) the approved NDAs and ANDAs provide Forest with the legal right to market the Products in the United States in accordance with such NDAs and ANDAs, including all of its approved supplements; (ii) Forest has all Registrations from the FDA required for it to develop and manufacture the Products and such Registration are in full force and effect, subject only to certain supplements which may be necessary as a result of changes in the location of the manufacture of one or more Products; (iii) to the Knowledge of Forest, there are no facts that would prevent the satisfaction of, or compliance with, any additional FDA requirements for marketing or distributing the Products in the United States. Forest has not received any notice that the FDA is, or may consider limiting, suspending, or revoking such Registrations; (iv) to Forest’s Knowledge, there is no false or misleading information or significant omission in an application, submission, or any other communication to the FDA regarding the Products; (v) subject only to certain supplements which may be necessary as a result of changes in the location of the manufacture of one or more Products, Forest has fulfilled and performed its obligations under each Registration in all respects, and shall no event has occurred or condition or state of facts exists which would constitute a breach or default that would cause revocation or termination of any such Registration; and, (vi) to the Knowledge of Forest, each Third Party supplier or manufacturer that is a party to a Product Rights Agreement or Manufacture and Supply Agreement complies with all applicable requirements of its Subsidiaries the FDA (including any drug establishment registration, drug listing, and good manufacturing requirements) to supply the Product to, and shall ensure that or manufacture the products sold by the Borrower or such SubsidiariesProduct for, comply in all material respects with all current Requirements of Law issued or administered by the FDAForest. (b) Neither Subject only to certain supplements which may be necessary as a result of changes in the Borrower nor any location of its Subsidiaries has receivedthe manufacture of one or more Products and the information set forth on Schedule 3.11(a) of the Forest Disclosure Schedule, Forest is in compliance with the Act and all applicable statutes, rules, regulations, standards, guidelines, registrations, policies and orders administered 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 issued by the FDA with respect to the products sold by Borrower or any of its SubsidiariesProducts and the Purchased Assets, including new drug approval, investigational new drugs, annual reporting, good manufacturing practices, record-keeping, adverse event reporting and labeling. (c) The premarket approval (“PMA”Other than as set forth on Schedule 3.11(a) and premarket notification (“510(k)”) documents and related documents and information for each of the products Forest Disclosure Schedule: (i) Forest is not subject to any obligation arising under any FDA administrative or regulatory action or from any FDA inspection, FDA warning letter, FDA notice of violation letter, recall notice, or any other notice from the FDA to Forest or its Affiliates alleging a violation of any Applicable Law or required Registration, or any response or other commitment made to or with the FDA regarding the Product or the Inventory, other than obligations arising from ownership of the Borrower and each of its Subsidiaries comply in all material respects with the applicable Requirements of Law administered or promulgated Registrations that are required by the FDA and set forth in the Borrower has no reason to believe that Act or in the approval letters for the NDAs or ANDAs and set forth in the FDA is considering limitingregulations, 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 material respects. (d) Neither the Borrower nor any of its Subsidiaries is aware of any facts or circumstances which are reasonably likely to cause (i) the denial, withdrawal, recall or suspension of any product sold or intended to be sold by the Borrower or any of its Subsidiaries, or (ii) a change in the marketing classification or labeling of any such products, or (iii) a termination or 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 Forest has not received any written or after April 1, 2001 of which the Borrower or any of its Subsidiaries has received other 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 within the period beginning two (2) years prior to market all products proposed as the date hereof alleging that the Products or the Inventory is the subject of any pending or threatened investigation in the Closing Date United States and, to the Knowledge of Forest, there are no facts or circumstances that would reasonably be introduced by it under a 510(k) clearance, and will not be required expected to file a PMA application with the FDA with respect give rise to any such productsnotice.