Product Registrations; Regulatory Compliance. (a) Section 3.19 of the Seller Disclosure Schedule sets forth, as of the date hereof, a list of all Transferred Registrations, including the owner thereof, except that the list of Transferred Registrations is not required to include Price Approvals. (b) Except as set forth on Section 3.19 of the Seller Disclosure Schedule: (i) each Transferred Registration is in effect, and to the Knowledge of Seller, as of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that would not be, individually or in the aggregate, material to the Business (taken as a whole); (ii) the Asset Selling Entities, collectively, have full right, title and interest in and to the Transferred Registrations, free and clear of any Liens (other than Permitted Liens); (iii) the Asset Selling Entities hold or control all Product Registrations and INDs, pending or issued, for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses for, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof (other than any authorizations necessary for the commercialization or distribution of the Product but that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); (iv) Seller and its applicable Affiliates are, and have been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the Product) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and (v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliates, to the Knowledge of Seller, were true, complete and correct as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Entity. (c) Since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller and its applicable Affiliates, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole). (d) Since January 1, 2017, there have been no recalls, field corrections, market withdrawals or replacements, safety alerts or other notice of action relating to any alleged lack of safety, efficacy or regulatory compliance of the Product (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there any facts existing as of the date hereof that would be reasonably likely to result in (i) a Safety Notice with respect to the Product, (ii) a change in labeling of the Product due to safety or efficacy concerns or (iii) a termination or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole). (e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise to any actual, alleged, possible or potential, (i) loss of or refusal to renew the Product Registrations relating to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force. (f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market. (g) Since January 1, 2017, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letter, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole). (h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole). (i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective Representatives or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole). (j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof. (k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof. (l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 2 contracts
Samples: Asset Purchase Agreement (Celgene Corp /De/), Asset Purchase Agreement (Amgen Inc)
Product Registrations; Regulatory Compliance.
(a) Section 3.19 Schedule 4.8(a) of the Seller Disclosure Schedule Schedules sets forth, as of the date hereof, a list of all Transferred RegistrationsProduct Registrations with respect to the Product in the United States, including which constitute all material registrations, applications, approvals, licenses or permits granted by any Governmental Authority and used by Seller or any Affiliate of Seller in the owner thereofExploitation of the Product since January 1, except that the list of Transferred Registrations is not required to include Price Approvals.2015.
(b) Except as set forth on Section 3.19 All of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effectProduct sold under the Product Registrations are, and at all times since January 1, 2015, have been manufactured and marketed in accordance with the specifications and standards contained in such Product Registrations and in accordance with applicable Laws, except where the failure to the Knowledge of Seller, as of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that comply therewith would not be, individually or in the aggregate, reasonably be expected to be material to the Business (Business, the Purchased Assets and the Product, taken as a whole);.
(iic) Seller is the Asset Selling Entities, collectively, have full right, title sole and interest in and to exclusive owner of the Transferred Product Registrations, free and clear of any Liens (Liens, other than Permitted Liens);Encumbrances.
(iiid) the Asset Selling Entities hold or control all (i) The Product Registrations are in full force and INDseffect, pending (ii) all product fees, establishment fees and other fees invoiced by or issued, payable to any Governmental Authority with respect to any of the Product Registrations for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses forannual period commencing October 1, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for2016, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof have been paid (other than any authorizations necessary for the commercialization or distribution of the Product but branded prescription drug fees that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);
(iv) Seller and its applicable Affiliates are, and have been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the ProductAssumed Liabilities) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
iii) there are no Proceedings pending (v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliatesor, to the Knowledge of Seller, were truethreatened) which could result in the revocation, complete and correct as cancellation or suspension of any of the date Product Registrations.
(e) Except as set forth on Schedule 4.8(e), no right of submission or reference has been granted to any necessary or required updates, changes, corrections or modifications Person with respect to such applications, submissions, information and data have been submitted to any of the FDA or other Governmental EntityProduct Registrations.
(cf) Since January 1To the Knowledge of Seller, 2017, there are no pending requirements to the extent applicable to the Transferred Assets conduct any Phase IV or the operations or conduct of the Business, Seller and its applicable Affiliates, have complied other clinical studies with all obligations arising from or related respect to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or Product of Seller in the aggregate, material to the Business (taken as a whole).United States for any approved indication.
(dg) Since January 1, 2017, there have been no recalls, field corrections, market withdrawals Neither Seller nor any of Seller’s Affiliates or replacements, safety alerts or other notice any of action relating to any alleged lack of safety, efficacy or regulatory compliance of the Product their respective contractors has (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there has any facts existing as of the date hereof that would be reasonably likely to result in other Person) at any time since January 1, 2015 (i) received or been subject to a Safety Notice with respect warning letter, untitled letter, Form FDA 483, or any other similar Governmental Authority notice or action relating to the any Product, ; (ii) a change in labeling been subject to any Governmental Authority detention, seizure, injunction, consent decree, notice of the Product due criminal investigation, indictment, sentencing memorandum, plea agreement, court order, target or no-target letter, or other investigation relating to safety or efficacy concerns any Product; or (iii) a termination initiated or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise been subject to any actualproduct recall, allegedmarket withdrawal, possible stock replacement or potential, (i) loss of or refusal to renew the Product Registrations post-sale warning relating to the any Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 2017, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letter, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective Representatives or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 1 contract
Product Registrations; Regulatory Compliance. (a) Section 3.19 Schedule 4.8(a) of the Seller Disclosure Schedule Schedules sets forth, as of the date hereof, a list of all Transferred RegistrationsProduct Registrations with respect to any of the Products in the Territory, including the owner thereofwhich constitute all material registrations, except that the list of Transferred Registrations is not required to include Price Approvalsapplications, approvals, licenses or permits granted by any Governmental Authority.
(b) Except as set forth on Section 3.19 All of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effectProducts sold under the Product Registrations are, and at all times since March 1, 2014, have been marketed in accordance with applicable Laws, except where the failure to the Knowledge of Seller, as of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that comply therewith would not be, individually or in the aggregate, reasonably be expected to be material to the Business (Business, the Purchased Assets and the Product, taken as a whole);.
(iic) Seller is the Asset Selling Entities, collectively, have full right, title and interest in and to licensee of the Transferred Product Registrations, free and clear of any Liens (Liens, other than Permitted Liens);Encumbrances.
(iiid) To Seller’s Knowledge: (i) the Asset Selling Entities hold or control all Product Registrations are in full force and INDseffect, pending (ii) all product fees, establishment fees and other fees invoiced by or issued, payable to any Governmental Authority with respect to any of the Product Registrations for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses forannual period commencing October 1, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for2015, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof have been paid (other than any authorizations necessary for branded prescription drug fees) and (iii) there are no Proceedings pending (or to the commercialization Seller's knowledge, threatened) which could result in the revocation, cancellation or distribution suspension of any of the Product but that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);Registrations.
(ive) Seller and its applicable Affiliates are, and have No right of reference has been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the Product) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
(v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity granted by Seller or to Seller’s Knowledge, the respective owners of the Product Registration to any Person with respect to any of its applicable Affiliates, to Product Registrations.
(f) To the Knowledge of Seller, were true, complete and correct as of the date of submission or there are no pending requirements to conduct any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA Phase IV or other Governmental Entityclinical studies with respect to any Product in the United States for any approved indication.
(cg) Since January 1, 2017, Neither Seller nor to the extent applicable to the Transferred Assets or the operations or conduct Seller’s Knowledge any of the Business, Seller and its applicable Affiliates, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business Seller’s contractors has (taken as a whole).
(d) Since January 1, 2017, there have been no recalls, field corrections, market withdrawals or replacements, safety alerts or other notice of action relating to any alleged lack of safety, efficacy or regulatory compliance of the Product (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there has any facts existing as of the date hereof that would be reasonably likely to result in other Person) at any time since March 1, 2014: (i) received or been subject to a Safety Notice with respect warning letter, untitled letter, Form FDA 483, or any other similar Governmental Authority notice or action relating to the any Product, ; (ii) a change in labeling been subject to any Governmental Authority detention, seizure, injunction, consent decree, notice of the Product due criminal investigation, indictment, sentencing memorandum, plea agreement, court order, target or no-target letter, or other investigation relating to safety or efficacy concerns any Product; or (iii) a termination initiated or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise been subject to any actualproduct recall, allegedmarket withdrawal, possible stock replacement or potential, (i) loss of or refusal to renew the Product Registrations post-sale warning relating to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 2017, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letter, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective Representatives or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 1 contract
Product Registrations; Regulatory Compliance. (a) Section 3.19 Schedule 4.8(a) of the Seller Disclosure Schedule Schedules sets forth, as of the date hereof, a list of all Transferred RegistrationsProduct Registrations with respect to any Products in the United States, including which constitute all material registrations, applications, approvals, licenses or permits granted by any Governmental Authority and used by Seller or any Affiliate of Seller in the owner thereofExploitation of the Products since February 4, except that the list of Transferred Registrations is not required to include Price Approvals2014.
(b) Except as set forth on Section 3.19 All of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effectProducts sold under the Product Registrations are, and at all times since February 4, 2014, have been manufactured and marketed in accordance with the specifications and standards contained in such Product Registrations and in accordance with applicable Laws, except where the failure to the Knowledge of Seller, as of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that comply therewith would not be, individually or in the aggregate, reasonably be expected to be material to the Business (Business, the Purchased Assets and the Product, taken as a whole);.
(iic) Seller is the Asset Selling Entities, collectively, have full right, title sole and interest in and to exclusive owner of the Transferred Product Registrations, free and clear of any Liens (Liens, other than Permitted Liens);Encumbrances.
(iiii) the Asset Selling Entities hold or control all The Product Registrations are in full force and INDseffect, pending (ii) all product fees, establishment fees and other fees invoiced by or issued, payable to any Governmental Authority with respect to any of the Product Registrations for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses forannual period commencing October 1, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for2015, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof have been paid (other than any authorizations necessary for the commercialization or distribution of the Product but branded prescription drug fees that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);
(iv) Seller and its applicable Affiliates are, and have been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the ProductAssumed Liabilities) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
iii) there are no Proceedings pending (v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliatesor, to the Knowledge of Seller, were truethreatened) which could result in the revocation, complete and correct as cancellation or suspension of any of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental EntityProduct Registrations.
(ce) Since January 1, 2017, No right of reference has been granted to the extent applicable any Person with respect to the Transferred Assets or the operations or conduct any of the Business, Seller and its applicable Affiliates, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole)Product Registrations.
(df) Since January 1, 2017To the Knowledge of Seller, there have been are no recalls, field corrections, market withdrawals or replacements, safety alerts pending requirements to conduct any Phase IV or other notice of action relating clinical studies with respect to any alleged lack Product of safety, efficacy Seller in the United States for any approved indication.
(g) Neither Seller nor any of Seller’s Affiliates or regulatory compliance any of the Product their respective contractors has (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there has any facts existing as of the date hereof that would be reasonably likely to result in other Person) at any time since February 4, 2014: (i) received or been subject to a Safety Notice with respect warning letter, untitled letter, Form FDA 483, or any other similar Governmental Authority notice or action relating to the any Product, ; (ii) a change in labeling been subject to any Governmental Authority detention, seizure, injunction, consent decree, notice of the Product due criminal investigation, indictment, sentencing memorandum, plea agreement, court order, target or no-target letter, or other investigation relating to safety or efficacy concerns any Product; or (iii) a termination initiated or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise been subject to any actualproduct recall, allegedmarket withdrawal, possible stock replacement or potential, (i) loss of or refusal to renew the Product Registrations post-sale warning relating to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 2017, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letter, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective Representatives or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 1 contract
Product Registrations; Regulatory Compliance. (a) Section 3.19 3.19(a) of the Seller Disclosure Schedule sets forth, as of the date hereof, a list of all Transferred Registrations, including the owner thereof, except that the list of Transferred Registrations is not required to include Price Approvals.
(b) Except as set forth on Section 3.19 3.19(b) of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effect, and to the Knowledge of Seller, as of the date of this Agreement, there Products are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that would not be, individually or in the aggregate, material to the Business (taken as a whole);
(ii) the Asset Selling Entities, collectively, have full right, title and interest in and to the Transferred Registrations, free and clear of any Liens (other than Permitted Liens);
(iii) the Asset Selling Entities hold or control all Product Registrations and INDs, pending or issued, for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses for, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof (other than any authorizations necessary for the commercialization or distribution of the Product but that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);
(iv) Seller and its applicable Affiliates are, and have been since January 1developed, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketingdesigned, promotion and distribution of the Product) and have manufactured, labeled, distributed, marketed and sold the Product in compliance with applicable Law (including applicable Healthcare Laws) and in accordance with the specifications and standards contained in the such Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
(vii) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliates, to the Knowledge of Seller, were true, complete and correct as of the date of submission or submission, and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been timely submitted to the FDA or other Governmental Entity.
(c) Since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller and its applicable Affiliates, have has complied with all obligations arising from or related to any commitments to any Governmental Entityapplicable Healthcare Laws in connection with the Products, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to operation of the Business and any commitments made in response to critical or major inspection findingsthe ownership, warning letters operation and similar correspondence, except as is not and would not reasonably be expected to be, individually or in use of the aggregate, material to the Business (taken as a whole)Transferred Assets.
(d) Since January 1, 2017Except as set forth on Section 3.19(d) of the Seller Disclosure Schedule, there have been no recalls, field corrections, market withdrawals or replacements, safety alerts alerts, seizures, field notifications, notifications of misbranding or adulteration or other notice of action relating to any alleged defect, lack of safety, efficacy or regulatory compliance of the Product Products or any other adverse regulatory action relating to the Business or the Transferred Assets (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there any facts existing as of the date hereof that would be reasonably likely to result in (i) a Safety Notice with respect to the ProductProducts, the Transferred Assets, or the Business, (ii) a change in labeling of the Product Products due to safety or efficacy concerns concerns; (iii) the withdrawal of, or material modification of, any Permit (including any Transferred Registration), or (iiiiv) a termination or suspension of marketing developing, marketing, distributing, or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole)Products.
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise to any actual, alleged, possible or potential, (i) loss of or refusal to renew the Product Registrations relating to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 2017, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letterWarning Letter, adverse inspectional finding, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity (i) alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually Products or in connection with the aggregateBusiness or the Transferred Assets or (ii) contesting the development, material manufacture, distribution, uses of or the labeling and promotion of any of the Products (collectively, “Additional Notices”). True and complete copies of all communications, reports, responses, notices and other correspondence (including comment letters, inspection results and remediation plans) from or to (A) Seller or any of its Affiliates, on the one hand, and (B) the FDA or any other Governmental Entity, on the other hand, in connection with any Safety Notice or Additional Notice have been made available to Purchaser.
(f) Except as set forth on Section 3.19(f) of the Seller Disclosure Schedule, there are not presently, and there previously have not been, any civil, criminal or administrative actions, suits, demands, claims, hearings, notices of violation, investigations, proceedings, demand letters, or other communications by any Governmental Authority alleging non-compliance on the part of Seller or any Seller Affiliate with applicable Healthcare Laws and relating to the Business Business, the Products, or the Transferred Assets, and to Seller’s Knowledge, no such actions are threatened.
(taken g) Except as a whole)set forth on Section 3.19(g) of the Seller Disclosure Schedule, there are not presently, and there previously have not been, any suits, demands, claims, proceedings, demand letters, or other communications by customers or other third parties relating to any alleged non-compliance by Seller or Seller’s Affiliates with the terms of any quality agreements or other contractual commitments regarding the quality or regulatory compliance and relating to the Business, the Products, or the Transferred Assets, and to Seller’s Knowledge, no such actions are threatened.
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Neither Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective its Representatives or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material relating to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted is currently excluded or debarred under applicable Law to participate in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by any United States federal or state health care programs or similar programs outside the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the ProductUnited States.
Appears in 1 contract
Product Registrations; Regulatory Compliance. (a) Section 3.19 Schedule 4.8(a) of the Seller Disclosure Schedule Schedules sets forth, as of the date hereof, a list of all Transferred RegistrationsProduct Registrations with respect to the Product in the United States, including which constitute all material registrations, applications, approvals, licenses or permits granted by any Governmental Authority and used by Seller or any Affiliate of Seller in the owner thereofExploitation of the Product since January 1, except that the list of Transferred Registrations is not required to include Price Approvals2015.
(b) Except as set forth on Section 3.19 All of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effectProduct sold under the Product Registrations are, and at all times since January 1, 2015, have been manufactured and marketed in accordance with the specifications and standards contained in such Product Registrations and in accordance with applicable Laws, except where the failure to the Knowledge of Seller, as of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that comply therewith would not be, individually or in the aggregate, reasonably be expected to be material to the Business (Business, the Purchased Assets and the Product, taken as a whole);.
(iic) Seller is the Asset Selling Entities, collectively, have full right, title sole and interest in and to exclusive owner of the Transferred Product Registrations, free and clear of any Liens (Liens, other than Permitted Liens);Encumbrances.
(iiii) the Asset Selling Entities hold or control all The Product Registrations are in full force and INDseffect, pending (ii) all product fees, establishment fees and other fees invoiced by or issued, payable to any Governmental Authority with respect to any of the Product Registrations for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses forannual period commencing October 1, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for2016, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof have been paid (other than any authorizations necessary for the commercialization or distribution of the Product but branded prescription drug fees that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);
(iv) Seller and its applicable Affiliates are, and have been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the ProductAssumed Liabilities) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
iii) there are no Proceedings pending (v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliatesor, to the Knowledge of Seller, were truethreatened) which could result in the revocation, complete and correct as cancellation or suspension of any of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental EntityProduct Registrations.
(ce) Since January 1Except as set forth on Schedule 4.8(e), 2017, no right of reference has been granted to the extent applicable any Person with respect to the Transferred Assets or the operations or conduct any of the Business, Seller and its applicable Affiliates, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole)Product Registrations.
(df) Since January 1, 2017To the Knowledge of Seller, there have been are no recalls, field corrections, market withdrawals or replacements, safety alerts pending requirements to conduct any Phase IV or other notice of action relating clinical studies with respect to any alleged lack Product of safety, efficacy Seller in the United States for any approved indication.
(g) Neither Seller nor any of Seller’s Affiliates or regulatory compliance any of the Product their respective contractors has (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there has any facts existing as of the date hereof that would be reasonably likely to result in other Person) at any time since January 1, 2015 (i) received or been subject to a Safety Notice with respect warning letter, untitled letter, Form FDA 483, or any other similar Governmental Authority notice or action relating to the any Product, ; (ii) a change in labeling been subject to any Governmental Authority detention, seizure, injunction, consent decree, notice of the Product due criminal investigation, indictment, sentencing memorandum, plea agreement, court order, target or no-target letter, or other investigation relating to safety or efficacy concerns any Product; or (iii) a termination initiated or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise been subject to any actualproduct recall, allegedmarket withdrawal, possible stock replacement or potential, (i) loss of or refusal to renew the Product Registrations post-sale warning relating to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 2017, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letter, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective Representatives or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), or any foreign equivalent thereof, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement or non-procurement programs, or (iv) convicted of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 1 contract
Product Registrations; Regulatory Compliance. (a) Section 3.19 A true, correct and complete list of the Seller Disclosure Schedule sets forth, as Product Registrations is set forth in Section 3.9(a) of the date hereof, a list of all Transferred Registrations, including the owner thereof, except that the list of Transferred Registrations is not required to include Price Approvals.
(b) Disclosure Schedule. Except as set forth on in Section 3.19 3.9(a) of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effect, Sellers are the sole and to the Knowledge of Seller, as exclusive owner of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that would not be, individually or in the aggregate, material to the Business (taken as a whole);
(ii) the Asset Selling Entities, collectively, have full right, title and interest in and to the Transferred Product Registrations, free and clear of any Liens (other than Permitted Liens);
(iii) , and no right of reference has been granted to any Person with respect to any of the Asset Selling Entities Product Registrations. Sellers hold or control all the Product Registrations and INDs, pending or issued, required for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses for, and all related applications and other information submitted for commercial sale of the purposes of or prepared in connection with obtaining the approval for, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product Products in the jurisdictions and in the manner marketed, distributed or countries where sold as of the date hereof (other than any authorizations necessary for the commercialization or distribution of the this Agreement and such Product but that Registrations are not Product-specific), except, valid and in each case, as is not full force and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);
(iv) Seller and its applicable Affiliates are, and have been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the Product) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
(v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliates, to the Knowledge of Seller, were true, complete and correct as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Entityeffect.
(cb) Since January 1Neither Seller has received any written notice, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller and its applicable Affiliates, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(d) Since January 1, 2017, there have been no recalls, field corrections, market withdrawals or replacements, safety alerts or other notice of action relating to any alleged lack of safety, efficacy or regulatory compliance of the Product (each, a “Safety Notice”), correspondence nor, to the Knowledge of SellerSellers, are there any facts existing as other type of notice, from the date hereof that would be reasonably likely to result in FDA, or any other Governmental Authority or Person threatening revocation, cancellation, suspension, non-renewal or adverse modification or contesting any of their Product Registrations.
(ic) a Safety Notice with respect Neither Seller has received written notice nor, to the ProductKnowledge of Sellers, (ii) a change any other type of notice, from the FDA that the clinical and pre-clinical studies, whether or not conducted under an IND, submitted to the FDA in labeling support of the Product due Registrations were not conducted in accordance with standard medical and scientific research procedures and all applicable Health Care Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312.
(d) Neither Seller has received any written notice nor, to safety or efficacy concerns or (iii) a termination or suspension the Knowledge of marketing or testing Sellers, any other type of notice, from the Product, in each case of the foregoing clauses (i) through (iii), except as is not and FDA which would not reasonably be expected to be, individually or in the aggregate, material lead to the Business (taken as a whole)denial of an application for marketing approval or other Product Registration currently pending before the FDA.
(e) Except as is not Each Seller has submitted the applications and would not reasonably be expected to be, individually or the FDA and applicable Governmental Authority in the aggregatecountries where the Products are commercially marketed to maintain the Product Registrations, material including drug registration and listing submissions to the Business (taken as FDA and has paid and is current with respect to all filing or other fees due to any Governmental Authority with respect thereto. To the Knowledge of Sellers, no director, officer, manager, employee or owner of Sellers has received a whole)written notice nor, to the Knowledge of SellerSellers, no event has occurred any other type of notice, that he or circumstance exists she is under investigation for conduct that (with or without notice or lapse of time or both) is reasonably likely to give rise to any actual, alleged, possible or potential, (i) loss of or refusal to renew the Product Registrations relating could result in debarments under 21 U.S.C. § 335a(a). With respect to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 2017Business, neither Seller nor any of its applicable Affiliates has received any FDA Form 483, warning letter, untitled letter or other correspondence, notice or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key officers, employees, have not been the subject of a civil or criminal legal actionowners, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employees, noragents or, to the Knowledge of SellerSellers, distributors, has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care programs under Section 1128 of their respective Representatives the Social Security Act of 1935, as amended, or those from whom they receive products any similar Law or services is currently program. None of the directors, officers, managers or, to the Knowledge of Sellers, employees or independent contractors of Sellers (i) debarred has been or is currently excluded under any U.S. Laws, including under 21 U.S.C. § 335a and pursuant to 42 U.S.C. § 1320a-7(a)§1320a-7 or similar exclusion authority, or any foreign equivalent thereofhas been or is currently debarred, (ii) debarred by the FDA (or subject to a similar sanction of a Governmental Entity), (iii) the subject of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity)suspended, or otherwise ineligible to participate in any federal healthcare programs health care program as that term is defined in 42 U.S.C. §1320a-7b(f) or federal procurement from any comparable state or non-procurement private insurance programs, or (ivii) has been convicted of a criminal offense or been fined in relation to the provision of health care items or services or any other offense that falls within the scope of may lead to exclusion under 42 U.S.C. § 1320a-7(a§1320a-7 or similar exclusion authorities, or may result in suspension or debarment from any health care program (federal, state, or private), but not yet excludedor (iii) is under investigation or subject to any type of judicial or administrative process for any health care fraud, debarredor is otherwise aware of any circumstances which may result in criminal or civil liability, suspended including conviction, fine, exclusion, debarment, suspension, or otherwise declared ineligibleother ineligibility to participate in any health care program (federal, except as has not been and would not reasonably be expected to bestate, individually or in the aggregate, material to the Business (taken as a wholeprivate).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 1 contract
Product Registrations; Regulatory Compliance. (a) Section 3.19 of the Seller Disclosure Schedule sets forth, as of the date hereof, a A true and complete list of all Transferred Registrations, including the owner thereof, except that the list of Transferred Product Registrations is not required to include Price Approvals.
(b) Except as set forth on Section 3.19 Schedule 4.8(a) of the Disclosure Schedules. Sellers are in compliance in all material respects with all Health Care Laws applicable to the conduct of the Business as currently conducted. No Seller Disclosure Schedule:
(i) each Transferred Registration is in effecthas received any notification of any pending or, to Knowledge of Sellers, threatened, Proceeding, hearing, enforcement, audit, inquiry, investigation, arbitration or other action from any Governmental Authority, including, without limitation, the FDA, the Centers for Medicare & Medicaid Services, and to the Knowledge U.S. Department of SellerHealth and Human Services Office of Inspector General, alleging potential or actual non-compliance by, or liability of, Sellers under any Health Care Law, except as of the date of this Agreement, there are no reasonably foreseeable circumstances justifying any revocation or suspension of any Transferred Registration in whole or in part, except, in each case, revocations or suspensions that would not benot, individually or in the aggregate, be material to the Business (taken as a whole);Business. All Products sold under the Product Registrations are, and at all times since January 1, 2012, have been, manufactured and marketed in all material respects in compliance with the specifications and standards contained in such Product Registrations and in compliance with all applicable Health Care Laws.
(iib) A Seller is the Asset Selling Entities, collectively, have full right, title sole and interest in and to exclusive owner of the Transferred Product Registrations, free and clear of any Liens (other than Permitted Liens);, and no right of reference has been granted to any Person with respect to any of the Product Registrations.
(iiic) the Asset Selling Entities Sellers hold or control all Product Registrations and INDs, pending or issued, required for the conduct of the Business as currently conducted, and such Product Registrations are valid and in full force and effect. Sellers have fulfilled and performed, and are performing, all of their obligations with respect to the Product Registrations, and no event has occurred that allows, or after notice or lapse of time would allow, revocation or termination thereof or result in any other impairment of the rights of the holder of any Product Registration. Sellers have not received any notice, letters or other correspondence from the FDA, or any other Governmental Authority or Person (i) contesting any of their Product Registrations or (ii) otherwise alleging any violation of Health Care Laws by Sellers. There are no civil, criminal or administrative Proceedings, hearings or other investigations pending or, to the Knowledge of Sellers, threatened, and no event has occurred that could result in a penalty under or the revocation, cancellation, suspension, nonrenewal or adverse modification of any Product Registration.
(d) To Knowledge of Sellers (which for this purpose shall include all be limited to the actual knowledge of the individuals listed in Schedule 1.1(e)), the clinical and pre-clinical studies, whether or not conducted under an IND, submitted to the FDA in support of the Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses forRegistrations were, and if still pending, are being conducted in accordance with standard medical and scientific research procedures and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval forapplicable Health Care Laws, including, but not limited to, the Product) that are required under applicable Law for Seller FDCA and its applicable Affiliates to marketimplementing regulations at 21 C.F.R. Parts 50, distribute 54, 56, 58 and sell the Product in the jurisdictions and in the manner marketed312, distributed or sold except as of the date hereof (other than any authorizations necessary for the commercialization or distribution of the Product but that are not Product-specific), except, in each case, as is not and would not reasonably be expected to benot, individually or in the aggregate, be material to the Business (taken as a whole);Business.
(ive) Seller and its applicable Affiliates are, and have been since January 1, 2017 There are no pending requirements to conduct any Phase IV or other clinical studies with respect to any Product in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology United States for any approved indication.
(including Laws relating to the marketing, promotion and distribution f) None of the Product) and have manufactured, labeled, distributed, marketed and sold Sellers has received any written information from the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and FDA which would not reasonably be expected to be, individually or in the aggregate, material lead to the Business (taken as a whole); anddenial of any application for marketing approval or other Product Registration currently pending before the FDA.
(vg) since January 1Each Seller has completed and filed all reports, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissionsdocuments, claims, reports permits and statisticsnotices required by any Governmental Authority in order to maintain the Product Registrations, including drug registration and other data and conclusions derived thereinlisting submissions to the FDA. To Knowledge of Sellers, utilized as the basis for no director, officer, employee, or submitted in connection with any and all requests for agent of Sellers has made an untrue statement of a Permit from the FDA material fact or other Governmental Entity, when submitted fraudulent statement to the FDA or any other Governmental Entity by Seller or any of its applicable AffiliatesAuthority, failed to the Knowledge of Seller, were true, complete and correct as of the date of submission or any necessary or disclose a material fact required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted be disclosed to the FDA or any other Governmental EntityAuthority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) or any similar policy. To Knowledge of Sellers, no director, officer, employee, or agent of Sellers has engaged in any conduct that has resulted, or would reasonably be expected to result, in debarments under 21 U.S.C. § 335a(a) or any similar Laws. With respect to the Business, neither Seller nor any of their respective officers, employees, agents or distributors has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Law or program.
(ch) Since January 1, 20172012, neither Seller has voluntarily or involuntarily initiated, conducted or issued, or caused to the extent applicable be initiated, conducted or issued, nor is either Seller aware of any circumstances reasonably likely to the Transferred Assets or the operations or conduct of the Businessgive rise to, Seller and its applicable Affiliatesany recall, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(d) Since January 1, 2017, there have been no recallsfield alerts, field corrections, market withdrawals withdrawal or replacementsreplacement, safety alerts alert, warning, “dear doctor” letter, investigator notice, safety alert, or other notice of or action relating to any an alleged lack of safety, efficacy or regulatory compliance of the Product (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there any facts existing as of the date hereof that would be reasonably likely to result in (i) a Safety Notice with respect to the Product, (ii) a change in labeling of the Product due to safety or efficacy concerns or (iii) a termination or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), to the Knowledge of Seller, no event has occurred or circumstance exists that (with or without notice or lapse of time or both) is reasonably likely to give rise to any actual, alleged, possible or potential, (i) loss of or refusal to renew the Product Registrations relating to the Product, or (ii) renewal of the Product Registrations on terms less advantageous to Seller or any of its Subsidiaries than the terms of those Product Registrations currently in force.
(f) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened or potential discontinuance or withdrawal from any market.
(g) Since January 1, 20172012, neither Seller nor any of its applicable Affiliates the Sellers has received any FDA Form 483, warning letter, untitled letter or other correspondence, written notice or communication from the FDA or other that any Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(h) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
Authority has (i) To the extent applicable commenced, or threatened to the Transferred Assets or the operations or conduct of the Business, neither Sellerinitiate, any action to request the recall of its applicable Affiliatesany Product sold or intended to be sold by Sellers or alleging any violations of any federal, any Transferred Employees, nor, to the Knowledge of Seller, any of their respective Representatives state or those from whom they receive products or services is currently (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a), local or any foreign equivalent thereofpayor “fraud and abuse,” consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements, (ii) debarred commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product sold or intended to be sold by the FDA (or subject to a similar sanction of a Governmental Entity)Sellers, (iii) the subject issued any demand letter, finding of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement deficiency or non-procurement programs, compliance or (iv) convicted adverse inspection report in respect of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the ProductBusiness.
Appears in 1 contract
Samples: Asset Purchase Agreement (Concordia Healthcare Corp.)
Product Registrations; Regulatory Compliance. (a) Section 3.19 of the Seller Disclosure Schedule sets forth, as of the date hereof, a A true and complete list of all Transferred Registrations, including the owner thereof, except that the list of Transferred Product Registrations is not required to include Price Approvals.
(b) Except as set forth on Section 3.19 Schedule 1.1(e). Seller is the sole and exclusive owner, free and clear of any Liens, except for Permitted Encumbrances, of the Seller Disclosure Schedule:
(i) each Transferred Registration is in effectProduct Registrations required for the conduct of its business as it relates to the Purchased Assets, as currently conducted by Seller, and to the Knowledge of Seller, as of the date of this Agreement, there such Product Registrations are valid and in full force and effect. Excluding the Contracts set forth in Section 4.8(a) of the Seller Disclosure Schedule, no reasonably foreseeable circumstances justifying right of reference has been granted to any Person with respect to any of the Product Registrations.
(b) Seller has, during the period in which Seller has owned the Purchased Assets, fulfilled and performed, and is performing, all of its material obligations with respect to the Product Registrations, and no event has occurred that allows, or after notice or lapse of time would allow, revocation or suspension termination thereof or result in any other impairment of the rights of the holder of any Transferred Registration in whole Product Registration. Seller has not received any written notice, letters or in partother correspondence from the FDA, except, in each case, revocations or suspensions that would not be, individually any other Governmental Authority or in Person (i) contesting any of the aggregate, material to the Business (taken as a whole);
Product Registrations or (ii) the Asset Selling Entitiesotherwise alleging any violation of Health Care Laws by Seller. There are no civil, collectivelycriminal or administrative Proceedings, have full right, title and interest in and to the Transferred Registrations, free and clear of any Liens (other than Permitted Liens);
(iii) the Asset Selling Entities hold or control all Product Registrations and INDs, pending or issued, for the Product (which shall include all FDA Product Marketing Authorizations and other U.S. and non-U.S. regulatory approvals and licenses for, and all related applications and other information submitted for the purposes of or prepared in connection with obtaining the approval for, the Product) that are required under applicable Law for Seller and its applicable Affiliates to market, distribute and sell the Product in the jurisdictions and in the manner marketed, distributed or sold as of the date hereof (other than any authorizations necessary for the commercialization or distribution of the Product but that are not Product-specific), except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole);
(iv) Seller and its applicable Affiliates are, and have been since January 1, 2017 in compliance with all Laws applicable to the Transferred Assets and the Transferred Product Technology (including Laws relating to the marketing, promotion and distribution of the Product) and have manufactured, labeled, distributed, marketed and sold the Product in accordance with specifications and standards contained in the Transferred Registrations, except, in each case, as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole); and
(v) since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, all applications, notifications, submissions, claims, reports and statistics, and other data and conclusions derived therein, utilized as the basis for or submitted in connection with any and all requests for a Permit from the FDA hearings or other Governmental Entity, when submitted to the FDA or other Governmental Entity by Seller or any of its applicable Affiliatesinvestigations pending or, to the Knowledge of Seller, were truethreatened, complete and correct as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Entity.
(c) Since January 1, 2017, to the extent applicable to the Transferred Assets or the operations or conduct of the Business, Seller and its applicable Affiliates, have complied with all obligations arising from or related to any commitments to any Governmental Entity, including all post-marketing study requirements, adverse event reporting, compliance with all applicable requirements under the statutes administered by the FDA, implementing FDA regulations and all similar foreign Laws applicable to the Business and any commitments made in response to critical or major inspection findings, warning letters and similar correspondence, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(d) Since January 1, 2017, there have been no recalls, field corrections, market withdrawals or replacements, safety alerts or other notice of action relating to any alleged lack of safety, efficacy or regulatory compliance of the Product (each, a “Safety Notice”), nor, to the Knowledge of Seller, are there any facts existing as of the date hereof that would be reasonably likely to result in (i) a Safety Notice with respect to the Product, (ii) a change in labeling of the Product due to safety or efficacy concerns or (iii) a termination or suspension of marketing or testing of the Product, in each case of the foregoing clauses (i) through (iii), except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(e) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole)and, to the Knowledge of Seller, no event has occurred during the period in which Seller has owned the Purchased Assets that could result in a penalty under or circumstance exists that (the revocation, cancellation, suspension, non-renewal or adverse modification of any Product Registration. Portions of this Exhibit, indicated by the mxxx “[***],” were omitted and have been filed separately with or without notice or lapse the Secretary of time or both) is reasonably likely to give rise to any actual, alleged, possible or potential, (i) loss of or refusal to renew the Product Registrations relating Commission pursuant to the Product, or (ii) renewal Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Product Registrations on terms less advantageous to Seller or any Securities Exchange Act of its Subsidiaries than the terms of those Product Registrations currently in force1934, as amended.
(fc) Except as is not Seller has completed and would not reasonably filed all material reports, documents, claims, permits and notices required by any Governmental Authority to be expected filed by it in order to bemaintain the Product Registrations, individually or in the aggregate, material including drug registration and listing submissions to the Business (taken FDA. In each case, as a whole)it relates to the Products, since January 1, 2017, the Product has not been discontinued or withdrawn from any market, and is not currently involved in any ongoing, and to the Knowledge of Seller, threatened no director, officer, employee, or potential discontinuance agent of Seller, has made an untrue statement of a material fact or withdrawal from fraudulent statement to the FDA or any market.
other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (gSept. 10, 1991) Since January 1or any similar policy. As it relates to the Products, 2017to the Knowledge of Seller, no director, officer, employee, or agent of Seller has engaged in any conduct that has resulted, or would reasonably be expected to result, in debarments under 21 U.S.C. § 335a(a) or any similar Laws. As it relates to the Products, to the Knowledge of Seller, neither Seller nor any of its applicable Affiliates officers, employees, agents or distributors has received been convicted of any FDA Form 483crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care programs under Section 1128 of the Social Security Act of 1935, warning letteras amended, untitled letter or other correspondence, notice any similar Law or communication from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws with respect to the Product, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole)program.
(hd) To the extent applicable Seller has not voluntarily or involuntarily initiated, conducted or issued, or caused to the Transferred Assets be initiated, conducted or the operations or conduct of the Business, Seller, its applicable Affiliates and their respective officers and key employees, have not been the subject of a civil or criminal legal action, investigation, audit, charges, administrative enforcement action or other adverse action by the FDA or another Governmental Entity, except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(i) To the extent applicable to the Transferred Assets or the operations or conduct of the Business, neither Seller, any of its applicable Affiliates, any Transferred Employeesissued, nor, to the Knowledge of Seller, do any circumstances exist that are reasonably likely to give rise to, any recall, field alerts, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert, or other notice or action relating to an alleged lack of their respective Representatives safety, efficacy or those from whom they receive products or services is currently regulatory compliance of any Product.
(e) Seller has not received any written notice that any Governmental Authority has (i) debarred or excluded under any U.S. Laws, including under 21 U.S.C. § 335a and 42 U.S.C. § 1320a-7(a)commenced, or threatened to initiate, any foreign equivalent thereofaction to request the recall of any Product sold or intended to be sold by Seller or alleging any violations of any federal, state or local or any payor “fraud and abuse,” consumer protection and false claims statutes and regulations or any pricing or rebate reporting requirements, (ii) debarred commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any Product sold or intended to be sold by the FDA (Seller or subject to a similar sanction of a Governmental Entity), (iii) the subject issued any demand letter, finding of an FDA debarment investigation or proceeding (or similar proceeding of a Governmental Entity), or otherwise ineligible to participate in federal healthcare programs or federal procurement deficiency or non-procurement programs, compliance or (iv) convicted adverse inspection report in respect of a criminal offense that falls within the scope of 42 U.S.C. § 1320a-7(a), but not yet excluded, debarred, suspended or otherwise declared ineligible, except as has not been and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole).
(j) Section 3.19(j) of the Seller Disclosure Schedule sets forth a list of all existing and planned clinical trials or similar studies to be conducted by Seller, any of its Affiliates or any third party engaged or supported by Seller or its Affiliates, relating to the Product or any Variant thereof as of the date hereof.
(k) Section 3.19(k) of the Seller Disclosure Schedule sets forth a list of all patient assistance programs, compassionate use programs and similar arrangements by which pharmaceutical products are provided, at reduced or no cost, in each case relating to the Product or any Variant thereof and in which Seller or any of its Affiliates participate as of the date hereof.
(l) Except as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), all pre-clinical and clinical trials conducted by Seller or any of its Affiliates with regard to the Product or the Transferred Assets have been conducted in material compliance with (A) applicable protocols and (B) all applicable Laws promulgated by the FDA and comparable Governmental Entities relating thereto, including without limitation the Federal Food, Drug, and Cosmetic Act (FDCA), and its applicable implementing regulations. Except as set forth on Section 3.19(l) of the Seller Disclosure Schedule, and as is not and would not reasonably be expected to be, individually or in the aggregate, material to the Business (taken as a whole), no IND filed by or on behalf of Seller with the FDA regarding the Product has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Governmental Entities has, to the Knowledge of Seller, commenced or threatened to initiate any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Product.
Appears in 1 contract
