Common use of Healthcare Regulatory Matters Clause in Contracts

Healthcare Regulatory Matters. (a) Except as does not constitute a Parent Material Adverse Effect, since the Applicable Date, (i) all Health Care Submissions required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority by Parent or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any officer, employee or agent of Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of Parent or any of its Subsidiaries (a “Parent Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of Parent or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy. (b) Neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer or employee of Parent or any of its Subsidiaries or any Parent Clinical Trial Investigator is or has been debarred pursuant to 21 U.S.C. § 335a (a) or (b). (c) Except as does not constitute a Parent Material Adverse Effect, (i) all Product Candidates under development by or on behalf of Parent or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of Parent or any of its Subsidiaries and (iv) neither Parent nor any of its Subsidiaries has received any written notice or communication alleging that Parent or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as does not constitute a Parent Material Adverse Effect, since the Applicable Date, neither Parent nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as does not constitute a Parent Material Adverse Effect, since the Applicable Date, Parent and each of its Subsidiaries has complied with, and has not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of Parent, any investigation with respect thereto) by Parent or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of Parent or any of its Subsidiaries.

Healthcare Regulatory Matters. (a) Except as does as, individually or in the aggregate, has not constitute had and would not reasonably be expected to result in a Parent Material Adverse Effect, since the Applicable Date, (i) all Health Care Submissions required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority by Parent or any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any officer, employee or agent of Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of Parent or any of its Subsidiaries (a “Parent Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of Parent or any of its Subsidiaries that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy. (b) Neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer or employee of Parent or any of its Subsidiaries or any Parent Clinical Trial Investigator is or has been excluded or suspended from a Government Health Care Program or debarred pursuant to 21 U.S.C. § 335a (a) or (b)) or disqualified from receiving investigational products or conducting clinical research, and no such debarment or disqualification proceedings are pending or threatened. (c) Except as does not constitute would not, individually or in the aggregate, reasonably be expected to result in a Parent Material Adverse Effect, (i) all Product Candidates under development by or on behalf of Parent or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of Parent or any of its Subsidiaries and (iv) neither Parent nor any of its Subsidiaries has received any written notice or communication alleging that Parent or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as does not constitute would not, individually or in the aggregate, reasonably be expected to result in a Parent Material Adverse Effect, since the Applicable Date, neither Parent nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as does not constitute would not, individually or in the aggregate, reasonably be expected to result in a Parent Material Adverse Effect, since the Applicable Date, Parent and each of its Subsidiaries has have complied with, and has have not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of Parent, any investigation with respect thereto) by Parent or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of Parent or any of its Subsidiaries.

Healthcare Regulatory Matters. (a) Except as does not constitute a Parent Company Material Adverse Effect, since the Applicable Date, (i) all Health Care Submissions filings, declarations, listings, registrations, reports, submissions, applications, amendments, modifications, supplements, notices, correspondence and other documents required to be filed or maintained with or furnished to the FDA or any other Healthcare Regulatory Authority (collectively, “Health Care Submissions”) by Parent or any of its Subsidiaries the Company have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither Parent or any of its Subsidiaries the Company nor, to the Knowledge of Parentthe Company, any officer, employee or agent of Parent or any of its Subsidiaries the Company acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of Parent or any of its Subsidiaries the Company (a “Parent Company Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority or committed any act, made any statement or failed to make any statement, in each case, related to the business of Parent or any of its Subsidiaries the Company that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy. (b) Neither Parent or any None of its Subsidiaries northe Company or, to the Knowledge of Parentthe Company, any director, officer or employee of Parent the Company or any of its Subsidiaries or any Parent Company Clinical Trial Investigator is or has been debarred pursuant to 21 U.S.C. § 335a (a) or (b). (c) Except as does not constitute a Parent Company Material Adverse Effect, (i) all Product Candidates under development by or on behalf of Parent or any of its Subsidiaries the Company have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of Parent or any of its Subsidiaries the Company have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of Parent or any of its Subsidiaries the Company and (iv) neither Parent nor any of its Subsidiaries the Company has not received any written notice or communication alleging that Parent or any of its Subsidiaries the Company has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as does not constitute a Parent Company Material Adverse Effect, since the Applicable Date, neither Parent nor any of its Subsidiaries the Company has not received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authority. (d) Except as does not constitute a Parent Company Material Adverse Effect, since the Applicable Date, Parent and each of its Subsidiaries the Company has complied with, and has not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of Parentthe Company, any investigation with respect thereto) by Parent or any of its Subsidiaries the Company or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect to any Product Candidates under development by or on behalf of Parent or any of its Subsidiariesthe Company.

Healthcare Regulatory Matters. (ai) Except as does The Company, the Continuing Subsidiaries and the other Seller Parties (with respect to the Business) (A) are in material compliance with and have conducted the Business in and used or occupied its properties or assets in compliance with the FDC Act and applicable foreign equivalent Laws and applicable Healthcare Laws, and (B) have not constitute received any written notice of any alleged violation of, or any citation for noncompliance with, any Healthcare Laws, in each of cases (A) and (B), that has had or would reasonably be expected to result in a Parent Material Adverse Effect. (ii) To Seller’s Knowledge, since none of the Applicable DateCompany, (i) all Health Care Submissions required to be filed or maintained with or furnished to the FDA any Continuing Subsidiary or any other Healthcare Regulatory Authority by Parent or any of its Subsidiaries have been so filed, maintained or furnished, Seller Party (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither Parent or any of its Subsidiaries nor, respect to the Knowledge of Parent, any officer, employee or agent of Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of Parent or any of its Subsidiaries (a “Parent Clinical Trial Investigator”Business) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Healthcare Regulatory Authority Governmental Authority, or committed any an act, made any statement a statement, or failed to make any statement, in each case, related to the business of Parent or any of its Subsidiaries a statement that, at the time such disclosure was made, would 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 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy. (biii) Neither Parent or any None of its Subsidiaries nor, to the Knowledge of ParentCompany, any directorContinuing Subsidiary, officer and any officer, employee or employee of Parent or any of its Subsidiaries or any Parent Clinical Trial Investigator is or agent thereof, has been debarred pursuant to convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a (a335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law by a Governmental Authority. To Seller’s Knowledge, which is based on, among other things, screening the Company’s and the Continuing Subsidiaries’ officers, employees and agents against the Exclusions Database of the HHS Office of Inspector General, none of the Company nor any Continuing Subsidiary, and any officer, employee or agent thereof, has been convicted of any crime or engaged in any conduct for which such person or entity could be excluded from participating in the federal health care programs under Section 1128 or Section 1877 of the Social Security Act of 1935, as amended (b)the “Social Security Act”) or any similar Law. None of the Company, any Continuing Subsidiary, and any officer, employee or agent thereof, has engaged in any conduct that could subject such Person or entity to a civil money penalty or criminal penalty under Sections 1128A or 1128B of the Social Security Act or any similar Law. (civ) Except as does not constitute To Seller’s Knowledge, there are no facts, circumstances or conditions that would reasonably be expected to form the basis for any investigation, suit, claim, action, proceeding or imposition of any penalties against or affecting the Company or any Continuing Subsidiary relating to or arising under a Parent Healthcare Law that has had or would reasonably be expected to have a Material Adverse Effect, individually or in the aggregate. (iv) all Product Candidates under development by or on behalf None of Parent Seller (with respect to the Business), the Company or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of Parent or any of its Continuing Subsidiaries and any other Seller Party (ivwith respect to the Business) neither Parent nor any of its Subsidiaries has received any written notice or communication alleging that Parent or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as does not constitute a Parent Material Adverse Effect, since the Applicable Date, neither Parent nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from other Governmental Authority has (A) commenced, or threatened to initiate, any other Healthcare Regulatory Authority or action to request the recall of any product, (B) commenced, or threatened to initiate, any other written notice action to enjoin reprocessing or distribution of violationsany product, inspectional observationsor (C) commenced, untitled letters or other written administrativethreatened to initiate, regulatory any action to enjoin the reprocessing or enforcement notice from the FDA distribution of any medical device produced at any facility where any product is reprocessed, tested, or any analogous Healthcare Regulatory Authorityheld. (dvi) Except The Company and the Continuing Subsidiaries do not possess any registrations, clearances or approvals issued under the FD&C Act (“FD&C Permits”). No FD&C Permits are required for the Company or the Company Subsidiaries to conduct the Business as does not constitute a Parent Material Adverse Effectpresently conducted. As of the date hereof, since neither the Applicable Date, Parent and each of its Subsidiaries has complied with, and has not been notified in writing by any Healthcare Regulatory Authority of any failure (or, to the Knowledge of ParentCompany’s, any investigation with respect thereto) by Parent of the Continuing Subsidiaries’ or any of its Subsidiaries or any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to the debarment of individuals, requirements applicable to the conflict of interest of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case other Seller Party’s (with respect to any Product Candidates under development by or on behalf of Parent or the Business) facilities nor any of their records have been inspected by the FDA. The Company, the Continuing Subsidiaries and the Seller Parties (with respect to the Business) have neither conducted any clinical studies in the United States nor sponsored the conduct of any clinical research in the United States that is subject to FDA regulation (i) since being owned or controlled by Seller and its SubsidiariesAffiliates, and (ii) to Seller’s Knowledge, prior to being owned or controlled by Seller and its Affiliates.

Healthcare Regulatory Matters. (a) Except as does The Acquired Companies do not constitute a Parent Material Adverse Effectand are not required to hold any Healthcare Permit required to operate their businesses, since provide services, or sell, distribute, manufacturer, test or use any of the Applicable DateAcquired Companies’ products or services. The Acquired Companies have not received any notice or been subject to any obligations under any adverse inspectional finding, penalty, fine, sanction, assessment, written request for corrective or remedial action, or other written compliance or enforcement notice alleging material non-compliance with any Healthcare Law or requirement to hold any Healthcare Permit. The Acquired Companies are not undergoing, and in the past three (3) years have not undergone, any inspection or investigation by any Governmental Entity with jurisdiction over any Healthcare Law. (b) Neither the Acquired Company nor any of its respective directors, managers, officers, employees, or any other person acting on behalf thereof (i) all Health Care Submissions required to be filed have been convicted of any crime or maintained engaged in any conduct for which they could be, excluded or debarred from any healthcare program, including a U.S. federal healthcare program (including Medicare, TRICARE or Medicaid); (ii) have been threatened with or furnished are currently subject to the FDA an investigation or proceeding that could result in suspension, exclusion or debarment from any U.S. federal healthcare program or inclusion in any other exclusion, debarment or sanction list or database; or (iii) have received notice from any Governmental Entity with respect to debarment or disqualification of any Person. No director, manager, officer, employee, or any other Healthcare Regulatory Authority by Parent or Person action on behalf of the Acquired Company, has (A) made any of its Subsidiaries have been so filed, maintained or furnished, (ii) all such Health Care Submissions were complete and accurate and in compliance with all applicable Laws when filed (or were corrected in or supplemented by a subsequent filing), and (iii) neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any officer, employee or agent of Parent or any of its Subsidiaries acting on its behalf or any clinical trial investigator conducting any clinical trial of a Product Candidate of Parent or any of its Subsidiaries (a “Parent Clinical Trial Investigator”) has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Healthcare Regulatory Authority, statement; (B) failed to disclose a material fact required to be disclosed to the FDA disclosed; or any other Healthcare Regulatory Authority or (C) committed any an act, made any statement a statement, or failed to make any statement, in each case, related to the business of Parent or any of its Subsidiaries that, at the time such disclosure was made, a statement that would reasonably be expected to provide a the basis for the FDA Food and Drug Administration to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, BriberyXxxxxxx, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Healthcare Regulatory Authority to invoke any similar policy. (b) Neither Parent or any of its Subsidiaries nor, to the Knowledge of Parent, any director, officer or employee of Parent or any of its Subsidiaries or any Parent Clinical Trial Investigator is or has been debarred pursuant to 21 U.S.C. § 335a (a) or (b).” (c) Except as does not constitute The Acquired Company has, maintained a Parent Material Adverse Effectcompliance program having the elements of an effective corporate compliance and ethics program identified in U.S.S.G. §8B2.1. There are no outstanding compliance complaints or reports, (i) all Product Candidates under development by or on behalf of Parent or any of its Subsidiaries have been researched, developed, tested, manufactured, handled, labeled, packaged, stored, supplied, distributed, imported and exported, as applicable, in compliance with all applicable Laws, (ii) all clinical trials conducted by or on behalf of Parent or any of its Subsidiaries have been conducted in compliance with applicable protocols, procedures and Laws, (iii) no Healthcare Regulatory Authority, institutional review board or ethics committee has commenced any action to place a clinical hold order onongoing internal investigations, or otherwise terminate or suspend, any ongoing clinical trial conducted by or on behalf of Parent or any of its Subsidiaries and (iv) neither Parent nor any of its Subsidiaries has received any written notice or communication alleging that Parent or any of its Subsidiaries has violated or failed to comply with any applicable Laws with respect to such clinical trials. Except as does not constitute a Parent Material Adverse Effect, since the Applicable Date, neither Parent nor any of its Subsidiaries has received: (A) any FDA Form 483 or warning letter from the FDA or any analogous notice from any other Healthcare Regulatory Authority or (B) any other written notice of violations, inspectional observations, untitled letters or other written administrative, regulatory or enforcement notice from the FDA or any analogous Healthcare Regulatory Authorityoutstanding compliance corrective actions. (d) Except as does Each Acquired Company is not constitute a Parent Material Adverse Effect, since the Applicable Date, Parent and each of its Subsidiaries has complied with, and has not been notified in writing by subject to HIPAA as a “business associate” or “covered entity”, as defined under HIPAA, nor has any Healthcare Regulatory Authority of any failure (orits directors, officers managers, or employees, nor to the Knowledge of Parentthe Company, independent contractors, ever used, disclosed, created, received, maintained, accessed, or transmitted protected health information, as defined by HIPAA, to conduct the business of such Acquired Company. (e) The Company has not engaged in any investigation with respect thereto) by Parent activity that involves the coding of medical claims, the submission of medical claims, or the receipt or sharing of professional medical collections to any governmental payors, third-party payors or patients. No Acquired Company has knowingly or willfully solicited, received, paid or offered to pay any remuneration, directly or indirectly, overtly or covertly, in cash or kind for the purpose of making or receiving any referrals or to induce business or otherwise illegally obtain business or payments from its customers or any of its Subsidiaries Person which violated any applicable Healthcare Laws. (f) No Acquired Company has ever employed or contracted with any licensor, licensee, partner or distributor to comply with, or maintain systems and programs to ensure compliance with, applicable Laws pertaining to product quality, notification of facilities and products, corporate integrity, pharmacovigilance and conflict of interest, including current Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to licensed healthcare personnel for the debarment of individuals, requirements applicable to the conflict of interest provision of clinical investigators and adverse drug reaction reporting requirements and clinical trial disclosure requirements, in each case with respect or clinical-related services delivered directly by such persons to any Product Candidates under development by or on behalf of Parent or any of its Subsidiariespatients.