Common use of Permits and Regulatory Matters Clause in Contracts

Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries have all material Permits required to conduct their businesses as currently conducted, including all such Permits required by the FDA or any other Governmental Entity exercising comparable authority (the “Public Company Authorizations”). (b) Public Company and its Subsidiaries are in compliance in all material respects with the terms of the Public Company Authorizations. No Public Company Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. (c) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public Company or any of its Subsidiaries are in compliance in all material respects with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority. As of the date of this Agreement, neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public Company there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority. (d) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulteration, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries being conducted, requested in writing or, to the knowledge of Public Company, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries. (e) The studies, tests and preclinical and clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of the date of this Agreement, neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries.

Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries have all material Permits permits, licenses, registrations, authorizations and franchises from Governmental Entities required to conduct their businesses as currently conducted or as currently proposed to be conducted, including without limitation all such Permits permits, licenses, registrations, authorizations and franchises required by the FDA or any other Governmental Entity exercising comparable authority (the “Public Company Authorizations”). (b) , except for such permits, licenses, registrations, authorizations and franchises the lack of which, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. Public Company and its Subsidiaries are in compliance in all material respects with the terms of the Public Company Authorizations, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. No Public Company Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. (cb) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public Company or any of its Subsidiaries are in compliance in all material respects with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. As of the date of this Agreement, neither Neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public Company there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably likely to have, a Public Company Material Adverse Effect. (dc) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulteration, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries being conducted, requested in writing or, to the knowledge of Public Company, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries. (ed) The studies, tests and preclinical and clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of the date of this Agreement, and neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries, except for such terminations, suspensions or material modifications that, individually or in the aggregate, have not had, and are not reasonably likely to have, a Public Company Material Adverse Effect.

Permits and Regulatory Matters. (a) Public Company and each of its Subsidiaries subsidiaries have all required Permits that are material Permits required to the conduct of their businesses as currently conducted, including all such Permits required by the FDA FDA, such as allowance of an IND, or any other Governmental Entity exercising comparable authority (the “Public Company Authorizations”). (b) Public Company and its Subsidiaries subsidiaries are in compliance in all material respects with the terms of the Public Company Authorizations. No Public Company Authorization shall cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. (c) . All manufacturingPublic Company Authorizations are in full force and effect, processingand no violations or notices of failure to comply have been issued or recorded in respect of any such Public Company Authorizations. All applications, distributionreports, labelingnotices and other documents required to be filed by Public Company and its subsidiaries with all Governmental Entities have been timely filed and are complete and correct in all material respects as of the date filed or as amended prior to the date of this Agreement. None of Public Company and its subsidiaries, storageand to Public Company’s knowledge, testingany officer, specifications, sampling, sale employee or marketing of products performed by or on behalf agent of Public Company or any of its Subsidiaries are subsidiaries has been convicted of any crime on behalf of Public Company that has previously caused or would reasonably be expected to result in compliance (A) disqualification or debarment by the FDA under 21 U.S.C. Sections 335(a) or (b), or any similar law, rule or regulation of any other Governmental Entity, or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar law, rule or regulation of any Governmental Entity. (c) Public Company is and at all times has been in all material respects compliance, to the extent applicable, with all applicable statutes, laws, rules, regulations (including all requirements relating to Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices) or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority, applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any pharmaceutical product tested, developed, promoted, marketed, manufactured or distributed by Merger Partner . As of the date of this Agreement, neither Neither Public Company nor any of its Subsidiaries subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authorityalleging or asserting any material noncompliance with any Public Company Authorizations; and (iii) has not received notice that any Governmental Entity has taken or is intending to take action to limit, suspend, modify or revoke any Public Company Authorizations (except where such limitation, suspension, modification, or revocation would not reasonably be expected to have a Public Company Material Adverse Effect) and to the knowledge of Public Company Company, there is no action or proceeding pending or threatened against Public Company (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries subsidiaries is not currently in compliance material noncompliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority. Neither Public Company nor any of its subsidiaries nor any of their respective officers, employees or agents have made an untrue statement of a material fact or fraudulent statement to any Governmental Entity or failed to disclose a material fact required to be disclosed to any Government Entity. (d) To Public Company’s knowledge, all preclinical and clinical investigations and trials sponsored by Public Company are being conducted in compliance in all material respects with applicable laws, including, as applicable, Good Manufacturing Practices, Good Clinical Practices and Good Laboratory Practices requirements and privacy laws. Public Company has not received any written notices from any Government Entity, institutional review board, independent ethics committee, data and safety monitoring board, or other oversight body with respect to any clinical or pre-clinical studies or tests, or chemistry, manufacturing, and control quality issues requiring the termination, suspension or material modification of such studies or tests and, to Public Company’s knowledge, there are no facts that would reasonably give rise to such an action (except where such material modification would not reasonably be expected to have a Merger Partner Material Adverse Effect, such as modifications that are part of routine correspondence with or sponsor-solicited feedback from any Governmental Entity). (e) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulteration, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries subsidiaries being conducted, requested in writing or, to the knowledge of Public Company, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiariessubsidiaries. (ef) The studies, tests and preclinical and clinical trials, if any, conducted by or on behalf of Public Company are being conducted or have been conducted in all material respects in accordance with approved study protocols and all applicable laws and regulations. The descriptions of, protocols for, and material data and other results of, any such studies, tests and/or trials that have been furnished or made available to Merger Partner are accurate and complete in all material respects with respect to what is currently known by or available to Public Company. Public Company is not aware of any studies, test or trials the results of which would cause Merger Public Company to reasonably believe the results would have a material adverse effect on the studies, tests and trials conducted by or on behalf of Public Company or any of its Subsidiaries were andCompany, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of the date of this Agreement, neither Public Company nor any of its Subsidiaries has not received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority or any institutional review board or comparable authority requiring the termination, clinical hold or partial clinical hold, suspension or material modification of any studiesIND, tests or preclinical or clinical trials conducted by or on behalf of Public Company (except where such material modification would not reasonably be expected to have a Public Company Material Adverse Effect, such as modifications that are for routine correspondence with or sponsor-solicited feedback from any of its SubsidiariesGovernmental Entity).

Permits and Regulatory Matters. (a) Public The Company and its Subsidiaries and, to the Knowledge of the Company, their respective officers, directors, employees, and Affiliates hold all licenses, permits (including extensions thereof), certificates, franchises, ordinances, registrations, qualifications, consents, approvals, waivers, filings, notices, or other rights, privileges, applications, variances, and authorizations filed with, granted or issued by, made with, or entered by any Governmental Entity or self-regulatory organization that are required for the conduct of the businesses of the Company and its Subsidiaries as currently being conducted, each as amended through the date hereof (collectively, the “Company Permits”), other than such Company Permits the absence of which would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. (b) Except as would not be reasonably expected to have, individually or in the aggregate, a Material Adverse Effect, the Company Permits are in full force and effect and have not been pledged or otherwise subject to a Lien or encumbered, assigned, suspended, modified, conditioned, canceled, revoked, or restricted. The Company and each of its Subsidiaries Subsidiaries, and, to the Knowledge of the Company, each of their respective officers, directors, employees and Affiliates thereof, have operated, and are operating, in compliance with all material Permits required terms of such Company Permits, and with all applicable Laws which apply to the conduct their of the businesses as currently conductedthereof, including and are in good standing in respect of all such Company Permits, other than in any case where the failure to so comply or operate or to be in good standing would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect. To the Knowledge of the Company, no event has occurred, or notice received, with respect to any of the Company Permits required by which allows or results in, or after notice or lapse of time or both would result in, revocation, suspension, or termination, modification, or the FDA imposition of any condition or restriction, thereof or would result in any other Governmental Entity exercising comparable authority (the “Public Company Authorizations”). (b) Public Company and its Subsidiaries are in compliance in all material respects with the terms impairment of the Public Company Authorizations. No Public Company Authorization shall cease to be effective as a result rights of the consummation holder of any such Company Permit other than as would not be reasonably expected, individually or in the transactions contemplated by this Agreementaggregate, to have a Material Adverse Effect. (c) All manufacturingTo the Knowledge of the Company, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public Company or any of its Subsidiaries are in compliance in all material respects with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other no Governmental Entity exercising comparable authority. As or self-regulatory organization has initiated any Proceeding, investigation, or examination into the business or operations of the date of this Agreement, neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public Company there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority. (d) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulteration, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries being conducted, requested in writing or, to the knowledge of Public Company, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries. (e) The studies, tests and preclinical and clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries were andofficer, if still pendingdirector, are being conducted in all material respects in accordance with experimental protocolsemployee or Affiliate thereof, procedures or has instituted any proceeding seeking to revoke, cancel or limit any Company Permit, and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of neither the date of this Agreement, neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries, nor any officer, director, employee or Affiliate thereof has received any notice of any unresolved material violation or exception by any Governmental Entity or self-regulatory organization with respect to any report or statement relating to any examination of the Company or any of its Subsidiaries, except in any case as would not reasonably be expected, individually or in the aggregate, to have a Material Adverse Effect.

Permits and Regulatory Matters. (a) Public The Company and each of its Subsidiaries have all material Permits permits, licenses, registrations, authorizations and franchises from Governmental Entities required to conduct their businesses as currently conducted or as currently proposed to be conducted, including without limitation all such Permits permits, licenses, registrations, authorizations and franchises required by the FDA or any other Governmental Entity exercising comparable authority authority, except for such permits, licenses, registrations, authorizations and franchises the lack of which, individually or in the aggregate, has not had, and is not reasonably expected to have, a Company Material Adverse Effect (the “Public Company Authorizations”). (b) Public . The Company and its Subsidiaries are in compliance in all material respects with the terms of the Public Company Authorizations, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably expected to have, a Company Material Adverse Effect. No Public Company Authorization shall will cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. (cb) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public the Company or any of its Subsidiaries are in compliance in all material respects with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably expected to have, a Company Material Adverse Effect. As of Neither the date of this Agreement, neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public the Company there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public the Company or any of its Subsidiaries is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority. (dc) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulterationmisbranding, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public the Company or any of its Subsidiaries being conducted, requested in writing or, to the knowledge of Public the Company, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public The Company has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert withdrawal or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries.a Governmental Entity (ed) The studies, tests and preclinical and clinical trials conducted by or on behalf of Public the Company or any of its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of and neither the date of this Agreement, neither Public Company nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of Public the Company or any of its Subsidiaries.

Permits and Regulatory Matters. (a) Public Company Baxano has all permits, licenses, registrations, authorizations and each of its Subsidiaries have all material Permits franchises from Governmental Entities required to conduct their businesses as currently conducted or as currently proposed to be conducted, including without limitation all such Permits permits, licenses, registrations, authorizations and franchises required by the FDA U.S. Food and Drug Administration (the “FDA”) or any other Governmental Entity exercising comparable authority authority, except for such permits, licenses, registrations, authorizations and franchises the lack of which, individually or in the aggregate, has not had, and is not reasonably expected to have, a Baxano Material Adverse Effect (the “Public Company Baxano Authorizations”). (b) Public Company and its Subsidiaries are . Baxano is in compliance in all material respects with the terms of the Public Company Baxano Authorizations, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably expected to have, a Baxano Material Adverse Effect. No Public Company Baxano Authorization shall will cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. (cb) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public Company or any of its Subsidiaries Baxano are in compliance in all material respects with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably expected to have, a Baxano Material Adverse Effect. As of the date of this Agreement, neither Public Company nor any of its Subsidiaries Baxano has not received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public Company Baxano there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company or any of its Subsidiaries Baxano is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority. (dc) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulterationmisbranding, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries Baxano being conducted, requested in writing or, to the knowledge of Public CompanyBaxano, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public Company Baxano has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert withdrawal or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiariesa Governmental Entity. (ed) The studies, tests and preclinical and clinical trials conducted by or on behalf of Public Company or any of its Subsidiaries Baxano were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of the date of this Agreement, neither Public Company nor any of its Subsidiaries and Baxano has not received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of Public Company or any of its SubsidiariesBaxano.

Permits and Regulatory Matters. (a) Public Company TranS1 and each of its Subsidiaries have all material Permits permits, licenses, registrations, authorizations and franchises from Governmental Entities required to conduct their businesses as currently conducted or as currently proposed to be conducted, including without limitation all such Permits permits, licenses, registrations, authorizations and franchises required by the FDA or any other Governmental Entity exercising comparable authority authority, except for such permits, licenses, registrations, authorizations and franchises the lack of which, individually or in the aggregate, has not had, and is not reasonably expected to have, a TranS1 Material Adverse Effect (the “Public Company TranS1 Authorizations”). (b) Public Company . TranS1 and its Subsidiaries are in compliance in all material respects with the terms of the Public Company TranS1 Authorizations, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably expected to have, a TranS1 Material Adverse Effect. No Public Company TranS1 Authorization shall will cease to be effective as a result of the consummation of the transactions contemplated by this Agreement. (cb) All manufacturing, processing, distribution, labeling, storage, testing, specifications, sampling, sale or marketing of products performed by or on behalf of Public Company TranS1 or any of its Subsidiaries are in compliance in all material respects with all applicable laws, rules, regulations or orders administered or issued by the FDA or any other Governmental Entity exercising comparable authority, except where the failure to so comply, individually or in the aggregate, has not had, and is not reasonably expected to have, a TranS1 Material Adverse Effect. As of the date of this Agreement, neither Public Company Neither TranS1 nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority, and to the knowledge of Public Company TranS1 there is no action or proceeding pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case alleging that Public Company TranS1 or any of its Subsidiaries is not currently in compliance with any and all applicable laws, regulations or orders implemented by the FDA or any other Governmental Entity exercising comparable authority. (dc) There are no seizures, recalls, market withdrawals, field notifications or corrective actions, notifications of misbranding or adulterationmisbranding, destruction orders, safety alerts or similar actions relating to the safety or efficacy of any products marketed or sold by Public Company TranS1 or any of its Subsidiaries being conducted, requested in writing or, to the knowledge of Public CompanyTranS1, threatened by the FDA or any other Governmental Entity exercising comparable authority. Public Company TranS1 has not, either voluntarily or involuntarily, initiated, conducted or issued or caused to be initiated, conducted or issued any recall, market withdrawal, safety alert withdrawal or other similar notice or action relating to the alleged lack of safety or efficacy of any products marketed or sold by Public Company or any of its Subsidiaries.a Governmental Entity (ed) The studies, tests and preclinical and clinical trials conducted by or on behalf of Public Company TranS1 or any of its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards; and, as of the date of this Agreement, and neither Public Company TranS1 nor any of its Subsidiaries has received any written notices or correspondence from the FDA or any other Governmental Entity exercising comparable authority requiring the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of Public Company TranS1 or any of its Subsidiaries.