Common use of Regulatory Issues Clause in Contracts

Regulatory Issues. (a) With respect to each Product and GSK Product, since January 1, 2008, except as set forth in Schedule 5.8(a) or as otherwise provided to Buyer in the Product Approvals, (i) neither Seller nor any of Seller’s Affiliates has received or been subject to any written notice from any Governmental Entity of adverse findings relating to any (x) Product in the Territory or (y) GSK Product that would reasonably be expected to have a Material Adverse Effect; (ii) there has not been any occurrence of any product recall, Market Withdrawal or post-sale warning conducted by or on behalf of Seller or its Affiliates concerning any (x) Product in the Territory or (y) GSK Product that would reasonably be expected to have a Material Adverse Effect; and (iii) to Seller’s Knowledge, no condition exists that reasonably could be expected to cause the termination or suspension of any of the Regulatory Approvals. (b) The Product Approvals are in full force and effect. There is no action or proceeding by any Governmental Entity pending or, to the Knowledge of Seller, threatened, seeking the recall of either Product or GSK Product or the revocation or suspension of any of the Product Approvals either (x) outside the Territory that would reasonably be expected to have a Material Adverse Effect or (y) in the Territory. As of the Agreement Date, Seller has made available to Buyer complete and correct copies of the Product Approvals. The Product Approvals, as set forth on Schedule 5.8(b), are the only Regulatory Approvals required from the FDA to distribute and sell each Product in the Territory in the manner as currently conducted and as conducted during the twelve (12) months prior to the Agreement Date. (c) To Seller’s Knowledge, there are no ANDA’s pending or filed with the FDA for either of the Products in the Territory. (d) All Product Regulatory Materials disclosed to Buyer are true, correct and complete in all material respects. (e) Notwithstanding the foregoing clause (a) and the second sentence of clause (b) above, Seller makes no representation to Buyer with respect to (i) written notices, if any, received by Buyer from any Governmental Entity of adverse findings relating to any Product, (ii) occurrences, if any, of any product recall, Market Withdrawal or post-sale warning conducted by Buyer concerning any Product, (iii) conditions, if any, of which Buyer has Knowledge, that reasonably could be expected to cause the termination or suspension of any of the Regulatory Approvals, and (iv) actions or proceedings, if any, threatened by any Governmental Entity that Buyer has Knowledge of that seek the recall of either Product or the revocation or suspension of any of the Product Approvals.

Regulatory Issues. (a) With respect to each Product and GSK Product, since January 1, 2008, except Except as set forth in Schedule 5.8(aSection 5.6 of the Disclosure Letter: (a) Since ****, with respect to Fanapt, such Seller or as otherwise provided to Buyer in the Product Approvals, (i) neither Seller nor any of Seller’s its Affiliates has not received or been subject to to: (i) any written notice from any Governmental Entity of adverse findings relating to any (x) Product in the Territory FDA 483’s or (yii) GSK Product any warning letters or other written correspondence from the FDA in which the FDA asserted that would reasonably be expected to have a Material Adverse Effect; the operations of such Seller or its Affiliates were not in compliance with applicable Governmental Orders or guidelines. Since ****, (iii) there has not been any occurrence of any product recall, Market Withdrawal market withdrawal or replacement, suspension, discontinuation or post-sale warning conducted by or on behalf of such Seller or its Affiliates (or any licensee, distributor or marketer) concerning Fanapt held by such Seller or any product recall, market withdrawal or replacement conducted by or on behalf of any entity as a result of any alleged defect in Fanapt and (xii) Product no Seller or its Affiliates has received any notice that any Governmental Entity has commenced, or to the Knowledge of Sellers, threatened to initiate, any action to withdraw or refuse approval, place sales or marketing restrictions on or request the recall of Fanapt, or has received any notice that any Governmental Entity has commenced, or, to the Knowledge of Sellers, threatened to initiate, any action to enjoin or place restrictions on the production of Fanapt. (b) Sellers have in their possession copies of all material documentation filed in connection with the Fanapt Registrations. The Fanapt Registrations are the only NDAs, INDs or foreign equivalents thereof that Sellers have obtained or for which Sellers have submitted applications in the Territory United States or Canada. (yc) GSK Product Sellers have made or filed all material declarations, notices, filings, reports, documents, claims, permits and notices with the FDA and any other Governmental Entity that would reasonably are necessary for the lawful sale or distribution, as applicable, of Fanapt. (d) In connection with Fanapt, the Fanapt Development Stage Products, the Fanapt Drug Substance and the Transferred Assets, no Seller or any of its Affiliates has, and to the Knowledge of the Sellers, no officer, employee or agent of any Seller or any of its Affiliates, has made any untrue statement of a material fact or a fraudulent statement, or failed to disclose a material fact required to be expected disclosed, to have a Material Adverse Effect; the FDA or any other Governmental Entity. (e) Since **** (i) Fanapt has, in all material respects, been manufactured, tested, packaged, labeled, held, distributed, marketed, imported, exported, sold and provided in compliance with applicable Law and applicable Regulatory Approvals and (iiiii) to Seller’s Knowledgethe Fanapt Development Stage Products, no condition exists that reasonably could be expected to cause the termination or suspension of any of the have in all material respects, been manufactured, tested, held, imported, exported and provided in compliance with applicable Law and applicable Regulatory Approvals. (bf) The Product Sellers possess or have the benefit of all material Regulatory Approvals necessary to manufacture (or have manufactured), sell or distribute Fanapt in those jurisdictions where Sellers or their Affiliates have manufactured, sold or distributed Fanapt, as the case may ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. be, and such Regulatory Approvals are in full force and effect. There Sellers are in compliance in all materials respects with the terms of all such Regulatory Approvals. No proceeding is no action or proceeding by any Governmental Entity pending or, to the Knowledge of SellerSellers, threatenedthreatened by a Governmental Entity since **** that is reasonably expected by Sellers to result in the revocation, seeking the recall of either Product or GSK Product or the revocation cancellation, non-renewal, adverse modification or suspension of any such Regulatory Approval. (g) Since ****, (i) none of Sellers nor their Affiliates, nor, to the Knowledge of Sellers, any employee, agent or subcontractor of any Seller, materially involved in the development and/or commercialization of Fanapt has been debarred under Subsection (a) or (b) of Section 306 of the Act; (ii) none of Sellers nor their Affiliates, nor, to the Knowledge of Sellers, any employee, agent or subcontractor of any Seller, materially involved in the development of any Fanapt Development Stage Product Approvals either has been debarred under Subsection (xa) outside or (b) of Section 306 of the Territory Act; and (iii) no Person who is known by Sellers to have been debarred under Subsection (a) or (b) of Section 306 of the Act has been employed by Sellers in the performance of any activities hereunder. (h) Since ****, to the Knowledge of Sellers, the development, manufacture, labeling and storage, as applicable, of Fanapt have been and are being conducted in compliance in all material respects with all applicable Laws including the FDA’s current Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices. Since ****, to the Knowledge of Sellers, the development of the Fanapt Development Stage Products has been and are being conducted in compliance in all material respects with all applicable Laws including the FDA’s current Good Laboratory Practices and Good Clinical Practices. In addition, Sellers and their Affiliates (i) have, at all times since ****, been and are in compliance in all material respects with all other applicable FDA requirements, including registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207 and (ii) have, at all times since ****, been and are in compliance in all material respects with all other applicable FDA requirements, including registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207. (i) Sellers and their Affiliates are and at all times since **** have been and, to the Knowledge of Sellers, all agents, representatives and contractors of Sellers are and at all times have been, in compliance in all material respects with the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), ▇▇▇▇▇ Law (42 U.S.C. Section 1395nn), False Claims Act (31 U.S.C. Section 3729 et seq.), Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), in each case as amended from time to time. (j) Since ****, no Seller or its Affiliates has engaged in (i) any unlawful or unauthorized practice of medicine or (ii) other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by any Seller or its Affiliates, in each case, with respect to Fanapt and the Fanapt Development Stage Products. (k) Since ****, Sellers and their Affiliates have operated the business in material compliance with import control Laws, including those administered by the United States Department of Commerce and the United States Department of State, or asset control laws, including those administered by the United States Department of Treasury, in each case that are applicable to Sellers with respect to the importation of Fanapt. ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (l) Since ****, no Seller nor its Affiliates nor, to the Knowledge of Sellers, any of the officers, employees, agents or clinical investigators of any Seller or its Affiliates has committed any act, made any statement or failed to make any statement that would reasonably be expected to have provide a Material Adverse Effect or (y) in the Territory. As of the Agreement Date, Seller has made available to Buyer complete and correct copies of the Product Approvals. The Product Approvals, as set forth on Schedule 5.8(b), are the only Regulatory Approvals required from basis for the FDA to distribute and sell each Product in the Territory in the manner as currently conducted and as conducted during the twelve (12) months prior to the Agreement Date. (c) To Seller’s Knowledge, there are no ANDA’s pending or filed with the FDA for either of the Products in the Territory. (d) All Product Regulatory Materials disclosed to Buyer are true, correct and complete in all material respects. (e) Notwithstanding the foregoing clause (a) and the second sentence of clause (b) above, Seller makes no representation to Buyer invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, in each case with respect to Fanapt and the Fanapt Development Stage Products. Since ****, no Seller nor its Affiliates nor, to the Knowledge of Sellers, any of the officers, employees or agents of any Seller or its Affiliates has been convicted of any crime or engaged in any conduct that has resulted in or would reasonably be expected to result in (i) written noticesdebarment under 21 U.S.C. Section 335a or any similar Law, if any, received by Buyer from any Governmental Entity of adverse findings relating to any Product, or (ii) occurrencesexclusion under 42 U.S.C. Section 1320a-7 or any similar Law, if any, of any product recall, Market Withdrawal or post-sale warning conducted by Buyer concerning any Product, (iii) conditions, if any, of which Buyer has Knowledge, that reasonably could be expected in each case with respect to cause Fanapt and the termination or suspension of any of the Regulatory Approvals, and (iv) actions or proceedings, if any, threatened by any Governmental Entity that Buyer has Knowledge of that seek the recall of either Product or the revocation or suspension of any of the Product ApprovalsFanapt Development Stage Products.

Regulatory Issues. a. The Company is licensed as a Class 4 VFA service provider in terms of the VFA Act, which licence has as of the Closing Date been voluntarily suspended for a temporary period in terms of Applicable Law and no circumstances have arisen which might lead to a revocation or permanent suspension of said license; b. By not later than 31st December 2022, the MFSA shall have given its consent, ‘no objection’ or similar decision in writing for the suspension of the VFA Licence to be lifted (ain such form and substance as is acceptable to the Purchaser) With respect such that, by such date, the Company will be in a position to each Product and GSK Product, since January 1, 2008, except as set forth in Schedule 5.8(a) or as otherwise provided to Buyer operate its business in the Product Approvalsordinary course; c. The Company has, as of the Closing Date, filed all returns, statutory forms, resolutions and documents required of it to submit to the Registrar, the MFSA or FIAU, as the case may be. There are no other correspondences with the MFSA or FIAU which have not been disclosed to the Purchaser; d. There has been no compliance visit or other visit by the MFSA, the FIAU or any other regulatory body in relation to the Company and/or its affairs which have not been disclosed to the Purchaser; e. The Company is not subject to any actual or threatened regulatory action which could or might result in the revocation or amendment of its license; or the imposition by any court of any injunction or garnishee order on its business; or the restriction of the Company’s business and/or operations in any manner whatsoever; f. The Company’s VFA License has been suspended on a purely voluntary basis upon its request and is not attributable to: (i) neither Seller nor any of Seller’s Affiliates has received or been subject to any written notice from any Governmental Entity of adverse findings relating to any (x) Product in the Territory or (y) GSK Product that would reasonably be expected to have a Material Adverse Effectregulatory reasons; (ii) there breach of law and/or regulation; and/or (iii) any other reason which has not been any occurrence of any product recalldisclosed in writing to the Purchaser; and g. The Company has complied, Market Withdrawal or post-sale warning conducted by or on behalf of Seller or its Affiliates concerning any (x) Product in the Territory or (y) GSK Product that would reasonably be expected to have a Material Adverse Effect; and (iii) to Seller’s Knowledgeis currently, no condition exists that reasonably could be expected to cause the termination or suspension of any shall, as of the Regulatory Approvals. (b) The Product Approvals are in full force and effect. There is no action or proceeding by any Governmental Entity pending or, to the Knowledge of Seller, threatened, seeking the recall of either Product or GSK Product or the revocation or suspension of any re-activation of the Product Approvals either (x) outside the Territory that would reasonably be expected to have a Material Adverse Effect or (y) in the Territory. As VFA Licence and as of the Agreement DateClosing Date be compliant with any and all conditions imposed by its license and any and all laws regulating its business, Seller has made available to Buyer complete including the VFA Act and correct copies of the Product Approvals. The Product Approvals, as set forth on Schedule 5.8(b), are the only Regulatory Approvals required from the FDA to distribute and sell each Product all rules issued thereunder and/or in the Territory in the manner as currently conducted and as conducted during the twelve (12) months prior to the Agreement Dateconnection therewith. (c) To Seller’s Knowledge, there are no ANDA’s pending or filed with the FDA for either of the Products in the Territory. (d) All Product Regulatory Materials disclosed to Buyer are true, correct and complete in all material respects. (e) Notwithstanding the foregoing clause (a) and the second sentence of clause (b) above, Seller makes no representation to Buyer with respect to (i) written notices, if any, received by Buyer from any Governmental Entity of adverse findings relating to any Product, (ii) occurrences, if any, of any product recall, Market Withdrawal or post-sale warning conducted by Buyer concerning any Product, (iii) conditions, if any, of which Buyer has Knowledge, that reasonably could be expected to cause the termination or suspension of any of the Regulatory Approvals, and (iv) actions or proceedings, if any, threatened by any Governmental Entity that Buyer has Knowledge of that seek the recall of either Product or the revocation or suspension of any of the Product Approvals.

Regulatory Issues. (a) With TXMD, its Subsidiaries and controlled Affiliates, and, to TXMD’s Knowledge, their contracted Third Party manufacturers, have developed, tested, investigated, labeled, packaged, manufactured, distributed, stored, shipped, commercialized, and promoted the Products, including any ingredients and components thereof, in material compliance with Healthcare Laws, including Food Regulatory Laws, including the FDCA and applicable implementing regulations issued by the FDA. (b) TXMD, its Subsidiaries and controlled Affiliates, and, to TXMD’s Knowledge, their contracted Third Party manufacturers, have been in compliance in all material respects with all laws related to the labeling, marketing and promotion of Products, including applicable Food Regulatory Laws. To the extent applicable, any claims made by or on behalf of TXMD regarding any Product (i) are materially accurate and substantiated, and (ii) have received all necessary approvals from the FDA or other Regulatory Authority or Governmental Entity, including all any applicable notifications or approvals relating to structure/function claims, nutrient content claims, and qualified health claims. To the extent required by applicable Law, all Products that are marketed with structure/function claims have disclosures that the FDA has not evaluated the claim and that the Product is not intended to diagnose, treat, cure or prevent any disease. To TXMD’s Knowledge, there have been no claims that any Products have been misbranded, mislabeled, or adulterated. (c) TXMD, its Subsidiaries and to TXMD’s Knowledge, their contracted Third Party manufacturers and Affiliates are and have been in material compliance with and have submitted and possesses all permits, NDAs, licenses, registrations, authorizations, certificates, orders, regulatory and marketing approvals and clearances (including any required new dietary ingredient premarket notifications), franchises, variances and other similar rights issued by or obtained from any Governmental Entities required to investigate, sell, manufacture, distribute, market, or otherwise commercialize the Products as currently conducted (collectively, “Permits”), including all such Permits required by the FDA and any other U.S. federal or state agencies or bodies or other Regulatory Authority engaged in the regulation of the Products. All such Permits of TXMD and the TXMD Group and, to TXMD’s Knowledge, their contracted Third Party manufacturers, are valid and in full force and effect. (d) All manufacturing operations conducted by or for the benefit of TXMD or the TXMD Group with respect to each the Products have been and are being conducted in material compliance with applicable Healthcare Laws including Food Regulatory Laws, including 21 C.F.R. 111, 210 and 211 and GMPs. TXMD has filed with the FDA and other applicable Governmental Entities all required notices, registration applications, order forms, reports, supplemental applications and annual or other reports or documents, including adverse experience reports and field alert reports, that are material to the continued Product and GSK ProductExploitation or otherwise required under Healthcare Laws, since January 1, 2008, except including Food Regulatory Laws. Except as set forth in on Schedule 5.8(a7.10(l), neither TXMD, nor its Subsidiaries, nor its controlled Affiliates, nor its contract manufacturers have received an FDA Form 483 or any other regulating authority notice of inspectional observations related to or affecting the Products, and there have been no voluntary or required recalls, market withdrawals, seizures, detentions or similar actions, or any material quality, safety efficacy or performance issues detected, defects, or complaints as it relates to the Products, or to TXMD’s Knowledge, its contract manufacturers that can potentially threaten any Product. (e) Neither TXMD, the TXMD Group or its Affiliates nor to TXMD’s Knowledge, any contractors with respect to any Product-related services performed for TXMD, has received any written notice or other communication from the FDA, USDA, FSIS, AMS, FTC, the Department of Justice, any state attorney general or any private enforcer acting as otherwise provided to Buyer in the Product Approvalsa private attorney general or other Regulatory Authority or Governmental Entity, including any Warning Letter, Untitled Letter, notice of violation letter, penalty, fine, sanction, assessment, clinical hold, written request for corrective or remedial action, investigation, or other compliance or enforcement notice (i) neither Seller nor contesting the marketing authorization of, the uses or investigation of, or the labeling and promotion of, any of Seller’s Affiliates has received or been subject to any written notice from any Governmental Entity of adverse findings relating to any (x) Product in the Territory or (y) GSK Product that would reasonably be expected to have a Material Adverse Effect; Products, (ii) there has not been any occurrence questioning, or alleging violations relating to, the regulatory status of any product recallProduct marketed as a dietary ingredient or dietary supplement or the promotional or labeling claims for such Product, Market Withdrawal (iii) otherwise stating or postalleging any violation applicable to any Product of any applicable Law, including any Healthcare Laws or Food Regulatory Laws, or (iv) otherwise questioning or raising material concerns about the safety or efficacy of a Product. (f) All non-sale warning clinical and preclinical studies, clinical trials and investigations of the Products conducted by or on behalf of Seller TXMD, the TXMD Group or its Affiliates concerning have been conducted in material compliance with the applicable investigational new drug application (“IND”) or other applicable clinical investigation exemption or authorization, protocol for such study or trial and all applicable and Healthcare Laws and GLPs and GCPs. No non-clinical studies, clinical trials, or investigations of the Products conducted by or on behalf of TXMD or the TXMD Group have been terminated or suspended prior to scheduled completion unless otherwise disclosed to Purchaser, and neither the FDA nor any other regulating authority or institutional review board have ever initiated, or, to TXMD’s Knowledge, threatened to initiate, any action to place a clinical hold order on, request to materially modify or otherwise terminate or suspend, any proposed, ongoing, or completed clinical trial, investigation or evaluation of any Product conducted by or on behalf of TXMD or the TXMD Group. TXMD, the TXMD Group, its Affiliates, and to TXMD’s Knowledge, its contractors as pertains to Product-related services performed for TXMD and the TXMD Group, are and have been, in substantial compliance with all applicable registration and listing requirements, including those set forth in 21 U.S.C. § 360 and 21 C.F.R. Parts 1 and 207 and all similar state and other Laws. (xg) To TXMD’s Knowledge, no Product in manufactured or distributed by or for TXMD or the Territory TXMD Group is or has been (i) adulterated within the meaning of 21 U.S.C. § 351 (or similar Laws), including applicable requirements of ▇▇ ▇.▇.▇. ▇▇▇▇▇ ▇▇▇, ▇▇▇, ▇▇▇, (▇▇) misbranded within the meaning of 21 U.S.C. § 352 (or similar Laws) or (yiii) GSK Product a product that is in violation of 21 U.S.C. § 360 (or similar Laws). (h) None of TXMD, its Subsidiaries, its controlled Affiliates, any officer or employee of TXMD or the TXMD Group or, to TXMD’s Knowledge, agent or representative acting for TXMD or the TXMD Group or its Affiliates have made an untrue statement of a material fact or fraudulent statement to the FDA or any Regulatory Authority relating to the Products, its Permits, or otherwise failed to disclose a material fact required to be disclosed to any regulatory authority relating to the Products or the Permits, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, could reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (10 September 1991) or any similar policy, Law, regulation or procedure of any other Governmental Authority. (i) None of TXMD, its Subsidiaries, Affiliates, any officer, director, employee or, to TXMD’s Knowledge, agent, representative or contractor of TXMD or its Subsidiaries or its Affiliates (i) has been charged with or convicted of any criminal offense or engaged in any conduct that has previously caused or would reasonably be expected to have a Material Adverse Effectresult in disqualification or debarment by any Governmental Entity, in each case relating to the delivery of an item or service under any Federal Health Care Program; and (ii) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (iii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the SSA; (iv) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; or (v) to SellerTXMD’s Knowledge, no condition exists that reasonably could be expected to cause is the termination target or suspension subject of any current or potential investigation relating to any Federal Health Care Program-related offense. The TXMD Group has not received verbal nor written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Entity alleging that any operation or activity of TXMD or any member of the Regulatory Approvals. (b) The Product Approvals are TXMD Group, in full force and effectconnection with the Products, the Transferred Assets or the Licensed IP, is in material violation of any Healthcare Laws. There To TXMD’s Knowledge, neither TXMD nor the TXMD Group is no action or proceeding under investigation by any Governmental Entity for a violation of HIPAA in connection with the Products, the Transferred Assets or the Licensed IP. Neither TXMD nor any member of the TXMD Group has received any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations. (j) Neither TXMD, the TXMD Group, nor any officer, director, employee, agent or contractor, or any other person engaged by or having a relationship with the TXMD Group, is, nor has been a party, to any corporate integrity agreement, individual integrity agreement, monitoring agreement, consent decree, settlement order, or similar agreement with or imposed by any regulatory authority in connection with the Products, the Transferred Assets or the Licensed IP. Neither TXMD nor the any member of the TXMD Group has not been subject to any type of investigation that is pending or, to the Knowledge of SellerTXMD’s Knowledge, that is pending and not served or threatened or that has been threatened, seeking in each case by the recall FDA, the Department of either Product or GSK Product Health and Human Services Office of Inspector General or the revocation Department of Justice pursuant to any Healthcare Laws with respect to the Products, the Transferred Assets or suspension of any of the Product Approvals either Licensed IP. (xk) outside the Territory that would reasonably be expected to have a Material Adverse Effect or (y) in the Territory. As of the Agreement Date, Seller has made available to Buyer complete and correct copies of the Product Approvals. The Product Approvals, Except as set forth on Schedule 5.8(b)7.10(k) of the TXMD Disclosure Schedules, are TXMD (i) it is in material compliance with all FDA and other Regulatory Authority postmarketing requirements for Products, including, but not limited to, as relates to the only Regulatory Approvals conduct of any required from postmarketing studies or other postmarketing commitments, and (ii) is materially on track to complete all such required Product postmarketing studies and other postmarketing commitments in accordance with the timelines requested by the FDA to distribute or other Regulatory Authority and sell each Product in the Territory in the manner as currently conducted and as conducted during the twelve (12) months prior to the Agreement Daterequested by such Regulatory Authority. (c) To Seller’s Knowledge, there are no ANDA’s pending or filed with the FDA for either of the Products in the Territory. (d) All Product Regulatory Materials disclosed to Buyer are true, correct and complete in all material respects. (e) Notwithstanding the foregoing clause (a) and the second sentence of clause (b) above, Seller makes no representation to Buyer with respect to (i) written notices, if any, received by Buyer from any Governmental Entity of adverse findings relating to any Product, (ii) occurrences, if any, of any product recall, Market Withdrawal or post-sale warning conducted by Buyer concerning any Product, (iii) conditions, if any, of which Buyer has Knowledge, that reasonably could be expected to cause the termination or suspension of any of the Regulatory Approvals, and (iv) actions or proceedings, if any, threatened by any Governmental Entity that Buyer has Knowledge of that seek the recall of either Product or the revocation or suspension of any of the Product Approvals.

Regulatory Issues. (a) With Section 3.25 of the Company Disclosure Schedule sets forth a complete and accurate list of any written communications between Company and the Food and Drug Administration ("FDA") or any other Governmental Authority that describe matters that could have a Company Material Adverse Effect attributable to any contemplated compound, product or product line of the Company. The Company has made available to the Parent copies of all such documents, as well as copies of all other information required to be maintained by the Company pursuant to the United States Federal Food, Drug and Cosmetic Act and Public Health Services Act and the corresponding applicable laws of jurisdictions other than the United States. (b) The Company and, to the knowledge of the Company, ▇▇▇▇▇▇▇▇ Pharma Ltd. ("▇▇▇▇▇▇▇▇") has with respect to each Product Gelclair, filed with the FDA and GSK Productall applicable state and local regulatory bodies for and received approval of all registrations, since January 1applications, 2008licenses, except requests for exemptions, permits and other regulatory authorizations necessary to conduct the business of Company as set forth in Schedule 5.8(a) currently conducted, the absence of which would, individually or as otherwise provided to Buyer in the Product Approvalsaggregate, (i) neither Seller nor any of Seller’s Affiliates has received or been subject to any written notice from any Governmental Entity of adverse findings relating to any (x) Product in the Territory or (y) GSK Product that would be reasonably be expected likely to have a Company Material Adverse Effect. The Company is, and at all relevant times has been, in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. To the knowledge of the Company, any third party which is a manufacturer for the Company (or ▇▇▇▇▇▇▇▇ with respect to Gelclair) is in compliance in all material respects with all FDA and Public Health Services registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations insofar as the same pertain to the manufacture of products for the Company. (c) The Company is, and at all relevant times has been, in compliance in all material respects with all material FDA, state and local rules, regulations, guidelines and policies, including, but not limited to, material FDA, state and local rules, regulations and policies relating to good manufacturing practice, good laboratory practice and good clinical practice; and the Company has no reason to believe that any party granting any such registration, application, license, request for exemption, permit or other authorization is considering limiting, suspending or revoking the same and knows of no basis for any such limitation, suspension or revocation. (iid) there The human clinical trials, animal studies and other preclinical tests conducted by the Company or in which the Company has not been participated, and such studies and tests conducted on behalf of the Company, were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, informed consents, procedures and controls generally used by qualified experts in the preclinical or clinical study of products comparable to those being developed by the Company. Neither the Company, nor any occurrence agent or representative of the Company nor, to the knowledge of the Company, any of its licensees and assignees of Company Intellectual Property, has received any notices or correspondence from the FDA or any other Governmental Authority requiring the termination, suspension or material modification of any product recallanimal studies, Market Withdrawal preclinical tests or post-sale warning clinical trials conducted by or on behalf of Seller or its Affiliates concerning any (x) Product in the Territory or (y) GSK Product that would reasonably be expected to have a Material Adverse Effect; and (iii) to Seller’s Knowledge, no condition exists that reasonably could be expected to cause the termination or suspension of any of the Regulatory Approvals. (b) The Product Approvals are in full force and effect. There is no action or proceeding by any Governmental Entity pending Company or, to the Knowledge knowledge of Sellerthe Company, threatenedsuch licensees and assignees of Company Intellectual Property, seeking or in which the recall Company or, to the knowledge of either Product the Company, such licensees and assignees of Company Intellectual Property, have participated. To the knowledge of the Company, no clinical investigator acting for the Company has been or GSK Product is now, or is threatened to become, the revocation or suspension subject of any disbarment or disqualification proceedings by any Governmental Authority. For purposes of the Product Approvals either (x) outside the Territory that would reasonably be expected to have a Material Adverse Effect or (y) in the Territory. As of the Agreement Date, Seller has made available to Buyer complete and correct copies of the Product Approvals. The Product Approvals, as set forth on Schedule 5.8(b), are the only Regulatory Approvals required from the FDA to distribute and sell each Product in the Territory in the manner as currently conducted and as conducted during the twelve (12) months prior to the Agreement Date. (c) To Seller’s Knowledge, there are no ANDA’s pending or filed with the FDA for either of the Products in the Territory. this paragraph (d) All Product Regulatory Materials disclosed all references to Buyer are true, correct and complete in all material respects. (e) Notwithstanding the foregoing clause (a) and the second sentence of clause (b) above, Seller makes no representation to Buyer Company shall include ▇▇▇▇▇▇▇▇ with respect to (i) written noticesGelclair only, if any, received qualified by Buyer from any Governmental Entity of adverse findings relating to any Product, (ii) occurrences, if any, of any product recall, Market Withdrawal or post-sale warning conducted by Buyer concerning any Product, (iii) conditions, if any, of which Buyer has Knowledge, that reasonably could be expected to cause the termination or suspension of any knowledge of the Regulatory Approvals, Company with respect to such matters described in this paragraph (d) and (iv) actions or proceedings, if any, threatened by any Governmental Entity that Buyer has Knowledge of that seek the recall of either Product or the revocation or suspension of any of the Product Approvalsinvolving ▇▇▇▇▇▇▇▇.

Regulatory Issues. (a) With respect to each Product and GSK Product, since January 1, 2008, except Except as set forth in Schedule 5.8(aSection 5.6 of the Disclosure Letter: (a) Since ****, with respect to Fanapt, such Seller or as otherwise provided to Buyer in the Product Approvals, (i) neither Seller nor any of Seller’s its Affiliates has not received or been subject to to: (i) any written notice from any Governmental Entity of adverse findings relating to any (x) Product in the Territory FDA 483’s or (yii) GSK Product any warning letters or other written correspondence from the FDA in which the FDA asserted that would reasonably be expected to have a Material Adverse Effect; the operations of such Seller or its Affiliates were not in compliance with applicable Governmental Orders or guidelines. Since ****, (iii) there has not been any occurrence of any product recall, Market Withdrawal market withdrawal or replacement, suspension, discontinuation or post-sale warning conducted by or on behalf of such Seller or its Affiliates (or any licensee, distributor or marketer) concerning Fanapt held by such Seller or any product recall, market withdrawal or replacement conducted by or on behalf of any entity as a result of any alleged defect in Fanapt and (xii) Product no Seller or its Affiliates has received any notice that any Governmental Entity has commenced, or to the Knowledge of Sellers, threatened to initiate, any action to withdraw or refuse approval, place sales or marketing restrictions on or request the recall of Fanapt, or has received any notice that any Governmental Entity has commenced, or, to the Knowledge of Sellers, threatened to initiate, any action to enjoin or place restrictions on the production of Fanapt. (b) Sellers have in their possession copies of all material documentation filed in connection with the Fanapt Registrations. The Fanapt Registrations are the only NDAs, INDs or foreign equivalents thereof that Sellers have obtained or for which Sellers have submitted applications in the Territory United States or Canada. (yc) GSK Product Sellers have made or filed all material declarations, notices, filings, reports, documents, claims, permits and notices with the FDA and any other Governmental Entity that would reasonably are necessary for the lawful sale or distribution, as applicable, of Fanapt. (d) In connection with Fanapt, the Fanapt Development Stage Products, the Fanapt Drug Substance and the Transferred Assets, no Seller or any of its Affiliates has, and to the Knowledge of the Sellers, no officer, employee or agent of any Seller or any of its Affiliates, has made any untrue statement of a material fact or a fraudulent statement, or failed to disclose a material fact required to be expected disclosed, to have a Material Adverse Effect; the FDA or any other Governmental Entity. (e) Since **** (i) Fanapt has, in all material respects, been manufactured, tested, packaged, labeled, held, distributed, marketed, imported, exported, sold and provided in compliance with applicable Law and applicable Regulatory Approvals and (iiiii) to Seller’s Knowledgethe Fanapt Development Stage Products, no condition exists that reasonably could be expected to cause the termination or suspension of any of the have in all material respects, been manufactured, tested, held, imported, exported and provided in compliance with applicable Law and applicable Regulatory Approvals. (bf) The Product Sellers possess or have the benefit of all material Regulatory Approvals necessary to manufacture (or have manufactured), sell or distribute Fanapt in those jurisdictions where Sellers or their Affiliates have manufactured, sold or distributed Fanapt, as the case may **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. be, and such Regulatory Approvals are in full force and effect. There Sellers are in compliance in all materials respects with the terms of all such Regulatory Approvals. No proceeding is no action or proceeding by any Governmental Entity pending or, to the Knowledge of SellerSellers, threatenedthreatened by a Governmental Entity since **** that is reasonably expected by Sellers to result in the revocation, seeking the recall of either Product or GSK Product or the revocation cancellation, non-renewal, adverse modification or suspension of any such Regulatory Approval. (g) Since ****, (i) none of Sellers nor their Affiliates, nor, to the Knowledge of Sellers, any employee, agent or subcontractor of any Seller, materially involved in the development and/or commercialization of Fanapt has been debarred under Subsection (a) or (b) of Section 306 of the Act; (ii) none of Sellers nor their Affiliates, nor, to the Knowledge of Sellers, any employee, agent or subcontractor of any Seller, materially involved in the development of any Fanapt Development Stage Product Approvals either has been debarred under Subsection (xa) outside or (b) of Section 306 of the Territory Act; and (iii) no Person who is known by Sellers to have been debarred under Subsection (a) or (b) of Section 306 of the Act has been employed by Sellers in the performance of any activities hereunder. (h) Since ****, to the Knowledge of Sellers, the development, manufacture, labeling and storage, as applicable, of Fanapt have been and are being conducted in compliance in all material respects with all applicable Laws including the FDA’s current Good Laboratory Practices, Good Manufacturing Practices and Good Clinical Practices. Since ****, to the Knowledge of Sellers, the development of the Fanapt Development Stage Products has been and are being conducted in compliance in all material respects with all applicable Laws including the FDA’s current Good Laboratory Practices and Good Clinical Practices. In addition, Sellers and their Affiliates (i) have, at all times since ****, been and are in compliance in all material respects with all other applicable FDA requirements, including registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207 and (ii) have, at all times since ****, been and are in compliance in all material respects with all other applicable FDA requirements, including registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207. (i) Sellers and their Affiliates are and at all times since **** have been and, to the Knowledge of Sellers, all agents, representatives and contractors of Sellers are and at all times have been, in compliance in all material respects with the federal Anti-Kickback Statute (42 U.S.C. Section 1320a-7b(b)), ▇▇▇▇▇ Law (42 U.S.C. Section 1395nn), False Claims Act (31 U.S.C. Section 3729 et seq.), Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), in each case as amended from time to time. (j) Since ****, no Seller or its Affiliates has engaged in (i) any unlawful or unauthorized practice of medicine or (ii) other professionally licensed activities through any websites sponsored or operated, or formerly sponsored or operated, by any Seller or its Affiliates, in each case, with respect to Fanapt and the Fanapt Development Stage Products. (k) Since ****, Sellers and their Affiliates have operated the business in material compliance with import control Laws, including those administered by the United States Department of Commerce and the United States Department of State, or asset control laws, including those administered by the United States Department of Treasury, in each case that are applicable to Sellers with respect to the importation of Fanapt. **** CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. (l) Since ****, no Seller nor its Affiliates nor, to the Knowledge of Sellers, any of the officers, employees, agents or clinical investigators of any Seller or its Affiliates has committed any act, made any statement or failed to make any statement that would reasonably be expected to have provide a Material Adverse Effect or (y) in the Territory. As of the Agreement Date, Seller has made available to Buyer complete and correct copies of the Product Approvals. The Product Approvals, as set forth on Schedule 5.8(b), are the only Regulatory Approvals required from basis for the FDA to distribute and sell each Product in the Territory in the manner as currently conducted and as conducted during the twelve (12) months prior to the Agreement Date. (c) To Seller’s Knowledge, there are no ANDA’s pending or filed with the FDA for either of the Products in the Territory. (d) All Product Regulatory Materials disclosed to Buyer are true, correct and complete in all material respects. (e) Notwithstanding the foregoing clause (a) and the second sentence of clause (b) above, Seller makes no representation to Buyer invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, in each case with respect to Fanapt and the Fanapt Development Stage Products. Since ****, no Seller nor its Affiliates nor, to the Knowledge of Sellers, any of the officers, employees or agents of any Seller or its Affiliates has been convicted of any crime or engaged in any conduct that has resulted in or would reasonably be expected to result in (i) written noticesdebarment under 21 U.S.C. Section 335a or any similar Law, if any, received by Buyer from any Governmental Entity of adverse findings relating to any Product, or (ii) occurrencesexclusion under 42 U.S.C. Section 1320a-7 or any similar Law, if any, of any product recall, Market Withdrawal or post-sale warning conducted by Buyer concerning any Product, (iii) conditions, if any, of which Buyer has Knowledge, that reasonably could be expected in each case with respect to cause Fanapt and the termination or suspension of any of the Regulatory Approvals, and (iv) actions or proceedings, if any, threatened by any Governmental Entity that Buyer has Knowledge of that seek the recall of either Product or the revocation or suspension of any of the Product ApprovalsFanapt Development Stage Products.