Common use of Permits; Regulatory Compliance Clause in Contracts

Permits; Regulatory Compliance. The Company and its subsidiaries have all authorizations, approvals, clearances, licenses, permits, certificates or exemptions (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, “Permits”) required to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse Effect. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects, with the Food, Drug, and Cosmetic Act of 7 1938, as amended, and other federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization, except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company or its subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any of its subsidiaries is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and its subsidiaries have not received any notice of adverse finding, warning letter, notice of violation, notice of action or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with any applicable laws or Permits. The Company and its subsidiaries have made all notifications, submissions and reports required by applicable federal, state and foreign laws, except to the extent that the failure to make such notifications, submission or reports would not have a Material Adverse Effect.

Permits; Regulatory Compliance. The Company and its subsidiaries have all authorizations, approvals, clearances, licenses, permits, certificates or exemptions (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, “Permits”) required to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse Effect. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects, respects with the Food, Drug, Drug and Cosmetic Act of 7 1938, as amended, amended and other similar federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization, commercialization except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company or its subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as of the date hereof, to the knowledge of the Company, no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any of its subsidiaries is in compliance in all material respects with all Permits insofar as they pertain to the manufacture of product components or products for the Company. The Company and its subsidiaries have not received any notice of adverse finding, warning letter, notice of violation, notice of action or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with any applicable laws or Permits. The Company and its subsidiaries have made all notifications, submissions and reports required by applicable federal, state and foreign laws, except to the extent that the failure to make such notifications, submission or reports would not have a Material Adverse Effect.

Permits; Regulatory Compliance. The Except as disclosed in the Company’s Form 20-F for the fiscal year ended December 31, 2018 or except as disclosed in Schedule 4n, the Company does not own any equity interest and its subsidiaries have all authorizationshas not made any loans or advances to or guarantees of indebtedness to any person, approvalscorporation, clearancespartnership or other entity and is not a party to any joint venture, licensesother than travel advances and expenses made in the ordinary course of business. Except as disclosed in Schedule 4n of the Disclosure Schedule or as disclosed in the Company’s Form 20-F for the fiscal year ended December 31, permits2018 and any 6-K filed thereafter, certificates or exemptions (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, “Permits”) required to conduct their respective businesses as currently conducted except to the extent that knowledge of the failure to have such Permits would not have a Material Adverse Effect. The Company, the conduct of business by the Company compliesas presently and proposed to be conducted is not subject to continuing oversight, and at all times has substantially compliedsupervision, in all material respects, with the Food, Drug, and Cosmetic Act of 7 1938, as amended, and other federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each regulation or examination by any governmental official or body of the Company’s productsUnited States, in whatever stage of development or commercializationany other jurisdiction wherein the Company conducts or proposes to conduct such business, except to (i) for the extent that applicable laws, rules and regulations governing the failure to so comply would not have a Material Adverse Effect. To drug and medical industry, including the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA” or “USFDA”), and other similar laws, rules and regulations or other agencies, and governmental authorities around the world applicable to the Company or to its products, (ii) nor any comparable regulatory authority or governmental agency as described in the Subscription Documents and except as such regulation is considering limitingapplicable to commercial enterprises generally, suspending or revoking any such Permit or changing applicable to the marketing classification or labeling of the products industry of the Company or any of its subsidiaries. To the knowledge of the Company, there is no false to all companies in Israel or misleading information or material omission biomed companies in any product application or other submission by the Company or any of its subsidiaries to the FDA or any comparable regulatory authority or governmental agencygeneral. The Company or its subsidiaries have fulfilled and performed in has obtained all material respects their obligations under each Permitlicenses, andpermits and other governmental authorizations necessary to conduct its business as presently conducted, as of except where the date hereof, failure to the knowledge of the Company, no event do so would not be reasonably expected to cause a Material Adverse Effect. The Company has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination not received any notice of any such Permit except violation of, or noncompliance with, any material federal, state, local or foreign laws, ordinances, regulations and orders (including, without limitation, those relating to environmental protection, occupational safety and health, securities laws, equal employment opportunity) applicable to its business, the extent that such breachviolation of, defaultor noncompliance with, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for and the Company knows of no facts or any set of its subsidiaries is in compliance in all material respects with all Permits insofar as they pertain circumstances which could give rise to the manufacture of product components or products for the Company. The Company and its subsidiaries have not received any notice of adverse finding, warning letter, notice of violation, notice of action or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with any applicable laws or Permits. The Company and its subsidiaries have made all notifications, submissions and reports required by applicable federal, state and foreign laws, except to the extent that the failure to make such notifications, submission or reports would not have a Material Adverse Effectnotice.

Permits; Regulatory Compliance. (a) The Company and its subsidiaries Subsidiaries are and since January 1, 2010, have been in possession and operating in material compliance with all required franchises, grants, authorizations, approvals, clearances, licenses, permits, certificates or exemptions (including manufacturing easements, variances, exceptions, consents, certificates, approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by orders of any regulatory authority or governmental agency (collectively, “Permits”) required Governmental Authority material to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse Effect. The conduct of business by the Company complies, and at all times has substantially complied, in all material respects, with the Food, Drug, and Cosmetic Act of 7 1938, as amended, and other federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization, except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its subsidiaries. To Subsidiaries in connection with the knowledge of the Companyownership, there is no false lease or misleading information or material omission in any product application or other submission by the Company or any operation of its subsidiaries to properties and the FDA or any comparable regulatory authority or governmental agencyoperation of its business consistent with its past practice (the “Company Permits”). The Company or its subsidiaries have fulfilled and performed in all material respects their obligations under each Permit, and, as As of the date hereofof this Agreement, no suspension or cancellation of any of the Company Permits is pending or, to the knowledge of the Company, no event has occurred threatened. Neither the Company nor any of its Subsidiaries is in violation of (i) any Company Permit or condition (ii) any applicable Law, including any consumer protection, equal opportunity, patient confidentiality, health, health care industry regulation and third-party reimbursement laws including under any Federal Health Care Program (as defined in Section 1128B(f) of the U.S. Federal Social Security Act), except in the case of clauses (i) or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Permit except to the extent that such breach, default, revocation or termination (ii) as would not have a Company Material Adverse Effect. (b) None of the Company or any of its Subsidiaries (i) is subject to any order or consent decree from any Governmental Authority, (ii) has received any Form 483s, shutdown or import or export prohibition, warning letter or untitled letters from the FDA or similar correspondence or notices or actions from any other Governmental Authority asserting noncompliance with any applicable Law, Company Permit or other requests or requirements of a Governmental Authority during the last three years or (iii) has received any communication from any Governmental Authority or been notified during the last three years that any product exemption, approval or clearance or other Company Permit is withdrawn or modified or that such an action is under consideration and the Company has not received any requests or requirements to make changes to any product or proposed product that, if not complied with, would have a Company Material Adverse Effect. (c) The clinical tests conducted by or, to the knowledge of the Company, with respect to the clinical trials conducted on behalf of or sponsored by the Company or its Subsidiaries or in which the Company or its products or product candidates or its Subsidiaries or its Subsidiaries’ products or product candidates have participated were and, if still pending, are being conducted in all material respects in accordance with the relevant clinical trial protocols, generally accepted medical and scientific research procedures and all applicable Laws, including the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations. No investigational device exemption filed by or on behalf of the Company or any of its Subsidiaries with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign regulatory agency has commenced, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or its Subsidiaries. (d) To the knowledge of the Company, all applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any third party that is and all requests for a manufacturer or contractor for Company Permit from a Governmental Authority relating to the Company and its Subsidiaries, their business and the Company and its Subsidiaries’ products and proposed products, when submitted to the FDA or any of its subsidiaries is in compliance other Governmental Authority were true, complete and correct in all material respects with all Permits insofar as they pertain of the date of submission and any necessary or required updates, changes, corrections or modification to the manufacture of product components or products for the Company. The Company such applications, submissions, information and its subsidiaries data have not received any notice of adverse finding, warning letter, notice of violation, notice of action or any other notice from been submitted to the FDA or other governmental agency alleging Governmental Authority. (e) There have been no recalls ordered or asserting noncompliance with any applicable laws or Permits. The Company and its subsidiaries have made all notificationsadverse regulatory actions taken or, submissions and reports required by applicable federal, state and foreign laws, except to the extent that knowledge of the failure Company, threatened by the FDA or any other Governmental Authority with respect to make any of the Company’s products, including any facilities where any such notificationsproducts are manufactured, submission processed, packaged or reports would not have stored by the Company or its Subsidiaries. (f) Neither the Company nor any of its Subsidiaries is the subject of any pending or, to the knowledge of the Company, threatened investigation in respect of the Company or Company products or proposed products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (g) Since January 1, 2010, neither the Company nor any of its Subsidiaries has been a Material Adverse Effectparty to any material litigation, arbitration or proceeding based upon a breach of warranty or guaranty or similar claim, strict liability in tort, negligent design of product, negligent provision of services or any other allegation of liability arising from the manufacture or sale of its products.

Permits; Regulatory Compliance. The Company (a) Section 6.9(a) of the Seller Disclosure Schedule contains a complete and its subsidiaries have all authorizationsaccurate list of each Regulatory Filing made or held by Seller for the Current Compounds and Current Products resulting from the Programs as currently conducted by Seller and material license, approvalsregistration, clearancesfranchise, licensesapplication, permitspermit or other similar authorization obtained by Seller to conduct the Programs as currently conducted by or on behalf of Seller, certificates together with the name of the Governmental or exemptions Regulatory Authority issuing such license or permit (including manufacturing approvals and authorizations, pricing and reimbursement approvals, labeling approvals, registration notifications or their foreign equivalent) issued by any regulatory authority or governmental agency (collectively, the “Permits”) required made or held by Seller. Each such Permit is valid and in full force and effect, except as could not be expected to have an Adverse Effect on the ability to conduct their respective businesses as currently conducted except to the extent that the failure to have such Permits would not have a Material Adverse EffectPrograms. The conduct of business by the Company complies, and at all times Seller has substantially complied, in all material respects, with the Food, Drug, and Cosmetic Act of 7 1938, as amended, and other federal, state and foreign laws applicable to the evaluation, testing, manufacturing, distribution, advertising and marketing of each of the Company’s products, in whatever stage of development or commercialization, except to the extent that the failure to so comply would not have a Material Adverse Effect. To the knowledge of the Company, as of the date hereof, neither the U.S. Food and Drug Administration (the “FDA”) nor any comparable regulatory authority or governmental agency is considering limiting, suspending or revoking any such Permit or changing the marketing classification or labeling of the products of the Company or any of its subsidiaries. To the knowledge of the Company, there is no false or misleading information or material omission in any product application or other submission by the Company or any of its subsidiaries to the FDA or any comparable regulatory authority or governmental agency. The Company or its subsidiaries have fulfilled and performed in all of its material respects their obligations under each Permit, and, as of the date hereof, with respect to the knowledge of the CompanyPermits, and no event has occurred occurred, and Seller has not received any notice in writing from any Governmental or condition Regulatory Authority or state otherwise of facts exists which would the occurrence of any event, that will constitute a breach violation of or default a failure to comply with any term or requirement of any such Permit, or that would cause revocation allow, or after notice or lapse of time would allow, the revocation, withdrawal, suspension, cancellation, or termination of any such Permit Permit, except as could not be expected to have an Adverse Effect on the ability to conduct the Programs. (i) Seller has furnished Buyer with access to complete copies of all INDs included in the Purchased Assets, (ii) Seller is and was, at all times prior to the extent that Closing Date, the lawful holder of all rights under the such breachINDs, default, revocation or termination would not have a Material Adverse Effect. To the knowledge of the Company, any third party that is a manufacturer or contractor for the Company or any of its subsidiaries is in compliance (iii) Seller has complied in all material respects with all Permits insofar as they pertain applicable Laws relating to such INDs , and with regard to actions taken directly by Seller, relating to the manufacture Current Compounds and Current Products, (iv) such INDs are effective, and nothing has come to Seller’s attention that has, or reasonably should have, led Seller to believe that such INDs are not in good standing with relevant regulatory authorities, (v) Seller has filed with the relevant Governmental or Regulatory Authorities all required notices, supplemental applications and annual or other reports, including adverse experience reports, with respect to such INDs, and (vi) there is no pending or, to the Knowledge of product components Seller, overtly threatened action by any relevant Government or products for Regulatory Authority that could be expected to have an Adverse Effect on the Company. ability to conduct the Programs. (c) The Company clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by Seller or in which the Current Compounds and Current Products have participated were and, if still pending, are being conducted in all material respect in accordance with standard medical and scientific research procedures and all applicable Laws, including, but not limited to, the Federal Food, Drug and Cosmetic Act and its subsidiaries have not received any notice of adverse findingapplicable implementing regulations at 21 C.F.R. Parts 50, warning letter54, notice of violation56, notice of action or any other notice from the FDA or other governmental agency alleging or asserting noncompliance with any applicable laws or Permits58 and 312. The Company and its subsidiaries have made all notifications, submissions and reports required by applicable federal, state and foreign laws, except Except to the extent that disclosed on Section 6.9(c) of the failure Seller Disclosure Schedule, no IND included in the Purchased Assets and filed by or on behalf of Seller with the FDA has been terminated or suspended by the FDA, and neither the FDA nor any applicable foreign Government or Regulatory Authority has commenced, or, to make such notificationsthe Knowledge of Seller, submission threatened to initiate, any action to place a clinical hold order on, or reports would otherwise terminate, delay or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Seller. (d) None of the executive officers of Seller have been disqualified or debarred by any Government or Regulatory Authority for any purpose, or have been charged with or convicted under any Law for conduct relating to the development or approval or otherwise relating to the regulation of any drug product under any Law; and (ii) Seller is not have a the subject of any pending or, to the Knowledge of Seller, threatened investigation in respect of Seller or the Current Compounds or Current Products by the FDA pursuant to its “Fraud, Untrue Statements of Material Adverse EffectFacts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.