Common use of Compliance with Legal Requirements; Regulatory Matters Clause in Contracts

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Target Companies is, and has during two years prior to the date of this Agreement been, in compliance in all material respects with all Legal Requirements, which are applicable to the business, properties, assets and activities of the Target Companies. During the two years prior to the date of this Agreement, none of the Target Companies has received any written notice or, to the knowledge of the Company, other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) Each Company Product is being or has been researched, developed, tested, manufactured, packaged, labeled, handled, stored, supplied, distributed, marketed, commercialized, imported, exported, and sold in compliance in all material respects with all Health Care Laws. (c) The Company has Made Available to Parent complete and correct copies of (i) each NDA and each IND submitted to the FDA and (ii) each marketing authorization application submitted to the European Medicines Agency, in each case with respect to the Company Products, including all supplements and amendments thereto. (d) Between December 31, 2020 and the date of this Agreement, the Company has not received any written communication from the FDA or any other Governmental Body, including any warning letter or untitled letter, that alleges or suggests that the Target Companies are not in compliance in all material respects with any applicable requirements under the Health Care Laws. (e) To the knowledge of the Company, as of the date of this Agreement, there are no pending or threatened material investigations, suits, claims, actions or other material Legal Proceeding against the Target Companies, including those relating to or arising under applicable Health Care Laws. Between December 31, 2020 and the date of this Agreement, no Target Company nor any of its officers or employees (in his or her capacity as such) has been or is subject to any enforcement proceedings by the FDA or any other Governmental Body. Between December 31, 2020 and the date of this Agreement, there has not been and is not now any Form FDA 483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information pending or in effect against the Target Companies or any of its officers or employees with respect to the Company Products, and Target Companies have no material liability (whether actual or contingent) for failure to comply with the applicable Health Care Laws. (f) The Target Companies have maintained reasonable records relating to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products in material compliance with the applicable Health Care Laws, and the Company has submitted to the FDA and other Governmental Bodies in a timely manner all required notices and annual or other reports, including adverse experience reports and annual reports, related to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products, except as would not be material to the Target Companies, taken as a whole. (g) Neither any of the Target Companies nor, to the knowledge of the Company, any officer, employee or agent of any of the Target Companies, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body which administers Health Care Laws, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting “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 or any similar policy. (h) All manufacturing operations relating to the Company Products conducted by or on behalf of Target Companies have been and are being conducted in compliance in all material respects with applicable provisions of Current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B), 21 C.F.R. Parts 210 and 211, and applicable final guidance documents, as amended from time to time. As of the date of this Agreement, no Company Product has been recalled, suspended, or discontinued by the Target Companies at the request of the FDA or any other Governmental Body. As of the date of this Agreement, no Target Company has received any notice from the FDA or any other applicable Governmental Body that it has commenced, or, to the knowledge of the Company, threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Product, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the production of any Company Product, except as would not be material to the Target Companies, taken as a whole. (i) All nonclinical studies and clinical trials relating to the Company Products conducted by or on behalf of the Target Companies have been, or are being, conducted in compliance in all material respects with the applicable requirements of the FDA’s Good Laboratory Practice and Good Clinical Practice requirements, including regulations under 21 C.F.R. Parts 50, 54, 56, 58, 312 and applicable guidance documents, as amended from time to time, the Animal Welfare Act, and all applicable similar Legal Requirements in other jurisdictions, and all Legal Requirements relating to protection of human subjects. (j) The Target Companies have promoted the Company Products in compliance in all material respects with all applicable Health Care Laws and other applicable Legal Requirements. As of the date of this Agreement, the Target Companies have not received, and to the Company’s knowledge, do not have pending or in effect any notice, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information from the FDA or any Governmental Body concerning material noncompliance with Health Care Laws and other Legal Requirements with regard to promotion of Company Products. (k) No Target Company, nor, to the Company’s knowledge, its officers, employees, agents or contractors, have been debarred or have been convicted of any crime or engaged in any conduct that resulted in debarment under 21 U.S.C. § 335a or disqualification as a clinical investigator under 21 C.F.R. § 312.70 or any similar Health Care Laws, and no Target Companies or, to the knowledge of the Company, any of its officers, employees, agents or contractors, has engaged in any conduct that would reasonably be expected to result in debarment or disqualification as an investigator. No Target Company, nor, to the Company’s knowledge, its officers, employees, agents or contractors, has been excluded or convicted of any crime for which exclusion from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Health Care Law, could result.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Target AcelRx Companies is, and has during at all times in the two years prior to the date of this Agreement (if applicable) been, in compliance in all material respects with all applicable Legal Requirements, which are applicable to the business, properties, assets and activities of the Target Companies. During the two years prior to the date of this Agreement, none of the Target Parent Companies has received any written notice or, to the knowledge of the CompanyParent, any other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) . Each Company Parent Product is being or has been researched, developed, tested, manufactured, packaged, labeled, handled, stored, supplied, distributed, marketed, commercialized, imported, exported, and sold in compliance in all material respects with all Health Care Laws. (c) The Company has Made Available to Parent complete and correct copies of (i) each NDA and each IND submitted to the FDA and (ii) each marketing authorization application submitted to the European Medicines Agency, in each case with respect to the Company Products, including all supplements and amendments thereto. (d) . Between December 31, 2020 2018 and the date of this Agreement, the Company Parent has not received any written communication from the FDA or any other Governmental Body, including any warning letter or untitled letter, that alleges or suggests that the Target AcelRx Companies are not in compliance in all material respects with any applicable requirements under the Health Care Laws. (eb) To the knowledge of the CompanyParent, as of the date of this Agreement, there are no pending or threatened material investigations, suits, claims, actions or other material Legal Proceeding against the Target CompaniesAcelRx Companies relating to the Parent Products, including those relating to or arising under applicable Health Care Laws. Between December 31, 2020 2018 and the date of this Agreement, no Target AcelRx Company nor any of its officers or employees (in his or her capacity as such) has been or is subject to any enforcement proceedings by the FDA or any other Governmental Body. Between December 31, 2020 2018 and the date of this Agreement, there has not been and is not now any Form FDA 483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information pending or in effect against the Target AcelRx Companies or any of its officers or employees with respect to the Company Parent Products, and Target the AcelRx Companies have no material liability (whether actual or contingent) for failure to comply with the applicable Health Care Laws. (f) The Target Companies have maintained reasonable records relating to the research, developmentexcept, testingin each case, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products in material compliance with the applicable Health Care Laws, and the Company has submitted to the FDA and other Governmental Bodies in a timely manner all required notices and annual or other reports, including adverse experience reports and annual reports, related to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products, except as would not be material to the Target AcelRx Companies, taken as a whole. (gc) Neither any of the Target AcelRx Companies nor, to the knowledge of the CompanyParent, any officer, employee or agent of any of the Target AcelRx Companies, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body Body, which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body Body, which administers Health Care Laws, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting “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 or any similar policy. (hd) All manufacturing operations relating to the Company Parent Products conducted by or on behalf of Target Parent Companies have been and are being conducted in compliance in all material respects with applicable provisions of Current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B), 21 C.F.R. Parts 210 and 211, and applicable final guidance documents, as amended from time to time. As of the date of this Agreement, no Company Parent Product has been voluntarily recalled, suspended, or discontinued by the Target AcelRx Companies at the request of the FDA or any other applicable Governmental Body. As of the date of this Agreement, no Target AcelRx Company has received any notice from the FDA or any other applicable Governmental Body that it has commenced, or, to the knowledge of the CompanyParent, threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Parent Product, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the production of any Company Parent Product, except as would not be material to the Target AcelRx Companies, taken as a whole. (i) . All nonclinical studies and clinical trials relating to the Company Parent Products conducted by or on behalf of the Target AcelRx Companies have been, or are being, conducted in compliance in all material respects with the applicable requirements of the FDA’s Good Laboratory Practice and Good Clinical Practice requirements, including regulations under 21 C.F.R. Parts 50, 54, 56, 58, 312 and applicable guidance documents, as amended from time to time, the Animal Welfare Act, and all applicable similar Legal Requirements in other jurisdictions, and all Legal Requirements relating to protection of human subjects. (je) The Target AcelRx Companies have promoted the Company Parent Products in compliance in all material respects with all applicable Health Care Laws and other applicable Legal Requirements. As of the date of this Agreement, the Target AcelRx Companies have not receivedreceived and, and to the CompanyParent’s knowledge, do not have pending or in effect any notice, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information from the FDA or any Governmental Body concerning material noncompliance with Health Care Laws and other Legal Requirements with regard to promotion of Company Parent Products. (kf) No Target AcelRx Company, nor, to the CompanyParent’s knowledge, its officers, employees, agents or contractors, have been debarred or have been convicted of any crime or engaged in any conduct that resulted in debarment under 21 U.S.C. § 335a or disqualification as a clinical investigator under 21 C.F.R. § 312.70 or any similar Health Care Laws, and no Target AcelRx Companies or, or to the knowledge of the CompanyParent, any of its officers, employees, agents or contractors, has engaged in any conduct that would reasonably be expected to result in debarment or disqualification as an investigator. No Target AcelRx Company, nor, to the CompanyParent’s knowledge, its officers, employees, agents or contractors, has been excluded or convicted of any crime for which exclusion from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Health Care Law, could result.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Target Tetraphase Companies is, and has during two years prior to the date of this Agreement been, in compliance in all material respects with all Legal Requirements, which are applicable to the business, properties, assets and activities of the Target Tetraphase Companies. During the two years prior to the date of this Agreement, none of the Target Tetraphase Companies has received any written notice or, to the knowledge of the Company, other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) Each Company Product is being or has been researched, developed, tested, manufactured, packaged, labeled, handled, stored, supplied, distributed, marketed, commercialized, imported, exported, and sold in compliance in all material respects with all Health Care Laws. (c) The Company has Made Available to Parent complete and correct copies of (i) each NDA and each IND submitted to the FDA and (ii) each marketing authorization application (“MAA”) submitted to the European Medicines Agency, in each case with respect to the Company Products, including all supplements and amendments thereto. (d) Between December 31, 2020 2018 and the date of this Agreement, the Company has not received any written communication from the FDA or any other Governmental Body, including any warning letter or untitled letter, that alleges or suggests that the Target Tetraphase Companies are not in compliance in all material respects with any applicable requirements under the Health Care Laws. (e) To the knowledge of the Company, as of the date of this Agreement, there are no pending or threatened material investigations, suits, claims, actions or other material Legal Proceeding against the Target CompaniesTetraphase Companies relating to the Company Products, including those relating to or arising under applicable Health Care Laws. Between December 31, 2020 2018 and the date of this Agreement, no Target Tetraphase Company nor any of its officers or employees (in his or her capacity as such) has been or is subject to any enforcement proceedings by the FDA or any other Governmental Body. Between December 31, 2020 2018 and the date of this Agreement, there has not been and is not now any Form FDA 483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information pending or in effect against the Target Tetraphase Companies or any of its officers or employees with respect to the Company Products, and Target Tetraphase Companies have no material liability (whether actual or contingent) for failure to comply with the applicable Health Care Laws. (f) The Target Tetraphase Companies have maintained reasonable records relating to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products in material compliance with the applicable Health Care Laws, and the Company has submitted to the FDA and other Governmental Bodies in a timely manner all required notices and annual or other reports, including adverse experience reports and annual reports, related to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products, except as would not be material to the Target Tetraphase Companies, taken as a whole. (g) Neither any of the Target Tetraphase Companies nor, to the knowledge of the Company, any officer, employee or agent of any of the Target Tetraphase Companies, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body Body, which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body Body, which administers Health Care Laws, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting “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 or any similar policy. (h) All manufacturing operations relating to the Company Products conducted by or on behalf of Target Tetraphase Companies have been and are being conducted in compliance in all material respects with applicable provisions of Current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B), 21 C.F.R. Parts 210 and 211, and applicable final guidance documents, as amended from time to time. As of the date of this Agreement, no Company Product has been voluntarily recalled, suspended, or discontinued by the Target Tetraphase Companies at the request of the FDA or any other Governmental Body. As of the date of this Agreement, no Target Tetraphase Company has received any notice from the FDA or any other applicable Governmental Body that it has commenced, or, to the knowledge of the Company, threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Product, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the production of any Company Product, except as would not be material to the Target Tetraphase Companies, taken as a whole. (i) All nonclinical studies and clinical trials relating to the Company Products conducted by or on behalf of the Target Tetraphase Companies have been, or are being, conducted in compliance in all material respects with the applicable requirements of the FDA’s Good Laboratory Practice and Good Clinical Practice requirements, including regulations under 21 C.F.R. Parts 50, 54, 56, 58, 312 and applicable guidance documents, as amended from time to time, the Animal Welfare Act, and all applicable similar Legal Requirements in other jurisdictions, and all Legal Requirements relating to protection of human subjects. (j) The Target Tetraphase Companies have promoted the Company Products in compliance in all material respects with all applicable Health Care Laws and other applicable Legal Requirements. As of the date of this Agreement, the Target Tetraphase Companies have not received, and to the Company’s knowledge, do not have pending or in effect any notice, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information from the FDA or any Governmental Body concerning material noncompliance with Health Care Laws and other Legal Requirements with regard to promotion of Company Products. (k) No Target Tetraphase Company, nor, to the Company’s knowledge, its officers, employees, agents or contractors, have been debarred or have been convicted of any crime or engaged in any conduct that resulted in debarment under 21 U.S.C. § 335a or disqualification as a clinical investigator under 21 C.F.R. § 312.70 or any similar Health Care Laws, and no Target Tetraphase Companies or, to the knowledge of the Company, any of its officers, employees, agents or contractors, has engaged in any conduct that would reasonably be expected to result in debarment or disqualification as an investigator. No Target Tetraphase Company, nor, to the Company’s knowledge, its officers, employees, agents or contractors, has been excluded or convicted of any crime for which exclusion from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Health Care Law, could result. (l) The Company has Made Available to Parent accurate and complete copies of any Health Care Law compliance policy or similar codes, policies, or guidelines adopted by the any of the Tetraphase Companies.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Target Tetraphase Companies is, and has during two years prior to the date of this Agreement been, in compliance in all material respects with all Legal Requirements, which are applicable to the business, properties, assets and activities of the Target Tetraphase Companies. During the two years prior to the date of this Agreement, none of the Target Tetraphase Companies has received any written notice or, to the knowledge of the Company, other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) Each Company Product is being or has been researched, developed, tested, manufactured, packaged, labeled, handled, stored, supplied, distributed, marketed, commercialized, imported, exported, and sold in compliance in all material respects with all Health Care Laws. (c) The Company has Made Available to Parent complete and correct copies of (i) each NDA and each IND submitted to the FDA and (ii) each marketing authorization application submitted to the European Medicines Agency, in each case with respect to the Company Products, including all supplements and amendments thereto. (d) Between December 31, 2020 2018 and the date of this Agreement, the Company has not received any written communication from the FDA or any other Governmental Body, including any warning letter or untitled letter, that alleges or suggests that the Target Tetraphase Companies are not in compliance in all material respects with any applicable requirements under the Health Care Laws. (e) To the knowledge of the Company, as of the date of this Agreement, there are no pending or threatened material investigations, suits, claims, actions or other material Legal Proceeding against the Target CompaniesTetraphase Companies relating to the Company Products, including those relating to or arising under applicable Health Care Laws. Between December 31, 2020 2018 and the date of this Agreement, no Target Tetraphase Company nor any of its officers or employees (in his or her capacity as such) has been or is subject to any enforcement proceedings by the FDA or any other Governmental Body. Between December 31, 2020 2018 and the date of this Agreement, there has not been and is not now any Form FDA 483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information pending or in effect against the Target Tetraphase Companies or any of its officers or employees with respect to the Company Products, and Target Tetraphase Companies have no material liability (whether actual or contingent) for failure to comply with the applicable Health Care Laws. (f) The Target Tetraphase Companies have maintained reasonable records relating to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products in material compliance with the applicable Health Care Laws, and the Company has submitted to the FDA and other Governmental Bodies in a timely manner all required notices and annual or other reports, including adverse experience reports and annual reports, related to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products, except as would not be material to the Target Tetraphase Companies, taken as a whole. (g) Neither any of the Target Tetraphase Companies nor, to the knowledge of the Company, any officer, employee or agent of any of the Target Tetraphase Companies, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body Body, which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body Body, which administers Health Care Laws, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting “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 or any similar policy. (h) All manufacturing operations relating to the Company Products conducted by or on behalf of Target Tetraphase Companies have been and are being conducted in compliance in all material respects with applicable provisions of Current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B), 21 C.F.R. Parts 210 and 211, and applicable final guidance documents, as amended from time to time. As of the date of this Agreement, no Company Product has been voluntarily recalled, suspended, or discontinued by the Target Tetraphase Companies at the request of the FDA or any other Governmental Body. As of the date of this Agreement, no Target Tetraphase Company has received any notice from the FDA or any other applicable Governmental Body that it has commenced, or, to the knowledge of the Company, threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Product, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the production of any Company Product, except as would not be material to the Target Tetraphase Companies, taken as a whole. (i) All nonclinical studies and clinical trials relating to the Company Products conducted by or on behalf of the Target Tetraphase Companies have been, or are being, conducted in compliance in all material respects with the applicable requirements of the FDA’s Good Laboratory Practice and Good Clinical Practice requirements, including regulations under 21 C.F.R. Parts 50, 54, 56, 58, 312 and applicable guidance documents, as amended from time to time, the Animal Welfare Act, and all applicable similar Legal Requirements in other jurisdictions, and all Legal Requirements relating to protection of human subjects. (j) The Target Tetraphase Companies have promoted the Company Products in compliance in all material respects with all applicable Health Care Laws and other applicable Legal Requirements. As of the date of this Agreement, the Target Tetraphase Companies have not received, and to the Company’s knowledge, do not have pending or in effect any notice, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information from the FDA or any Governmental Body concerning material noncompliance with Health Care Laws and other Legal Requirements with regard to promotion of Company Products. (k) No Target Tetraphase Company, nor, to the Company’s knowledge, its officers, employees, agents or contractors, have been debarred or have been convicted of any crime or engaged in any conduct that resulted in debarment under 21 U.S.C. § 335a or disqualification as a clinical investigator under 21 C.F.R. § 312.70 or any similar Health Care Laws, and no Target Tetraphase Companies or, to the knowledge of the Company, any of its officers, employees, agents or contractors, has engaged in any conduct that would reasonably be expected to result in debarment or disqualification as an investigator. No Target Tetraphase Company, nor, to the Company’s knowledge, its officers, employees, agents or contractors, has been excluded or convicted of any crime for which exclusion from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Health Care Law, could result. (l) The Company has Made Available to Parent accurate and complete copies of any Health Care Law compliance policy or similar codes, policies, or guidelines adopted by the any of the Tetraphase Companies.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Target Companies The Company is, and has during two years prior to the date of this Agreement at all times been, in compliance in all material respects with all Legal Requirements, which Requirements that are applicable to the business, properties, assets and activities of the Target CompaniesCompany, including the FDA Act. During the two years prior to the date of this Agreement, none of the Target Companies The Company has not received any written notice or, to the knowledge of the Company, other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect ofviolation, or failure to comply in any material respect with, or any investigation in respect of any violation of, any applicable Legal Requirement. The Company has filed, maintained or furnished to the FDA and all other applicable Governmental Bodies all documents, correspondences, filings, submissions, amendments, modifications, notices and responses to notices, applications and supplemental applications and reports (including all reportable adverse event/experience reports) required to be filed, maintained or furnished by the Company under applicable Legal Requirements in all material respects, and all such submissions were complete and accurate and in material compliance with applicable Legal Requirements when filed (or were corrected or completed in a subsequent filing). (b) Each Company Product is being or has been researched, developed, tested, manufactured, packaged, labeled, handled, stored, supplied, distributed, marketed, commercialized, imported, exported, supplied and sold distributed in compliance in all material respects with all Health Care Laws, including the FDA Act. (c) The Company has Made Available to Parent complete and correct copies of (i) each NDA and each IND submitted to the FDA and (ii) each marketing authorization application submitted to the European Medicines Agency, in each case with respect to the Company Products, including all supplements and amendments thereto. (d) Between December 31, 2020 and the date of this Agreement, the Company has not received any written communication from the FDA or any other Governmental Body, including any warning letter or untitled letter, that alleges or suggests that the Target Companies are Company is not in compliance in all material respects with any applicable requirements under the Health Care Laws. (ed) To There have been no pending or, to the knowledge of the Company, as of the date of this Agreement, there are no pending or threatened material investigations, suits, claims, actions or other material Legal Proceeding against the Target CompaniesCompany relating to the Company Products, including those relating to or arising under applicable Health Care Laws. Between December 31Neither the Company nor, 2020 and to the date of this AgreementCompany’s knowledge, no Target Company nor any of its officers officers, directors or employees (in his or her capacity as such) has been or is subject to any enforcement proceedings initiated by the FDA or any other Governmental Body. Between December 31, 2020 and To the date knowledge of this Agreementthe Company, there has not been and is not now any Form FDA 483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information pending or in effect against the Target Companies Company or any of its officers or employees with respect to the Company Products, and Target Companies have the Company has no material liability (whether actual or contingent) for failure to comply with the applicable Health Care Laws. The Company has not received any complaint, allegation, assertion or claim for (i) personal injury, death or property or economic damages, (ii) contribution or indemnification, (iii) punitive or exemplary damages, or (iv) injunctive relief, in each case based upon strict liability in tort, negligent design of product, negligent provision of services or any other allegation of liability in connection with any Company Product or any clinical trial involving a Company Product, and ,to the knowledge of the Company, there are no factual circumstances that could reasonably be expected to lead to such notices, allegations or claims. (fe) The Target Companies have maintained reasonable records relating to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of Neither the Company Products in material compliance with the applicable Health Care Laws, and the Company has submitted to the FDA and other Governmental Bodies in a timely manner all required notices and annual or other reports, including adverse experience reports and annual reports, related to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products, except as would not be material to the Target Companies, taken as a whole. (g) Neither any of the Target Companies nor, to the knowledge of the Company, any officer, employee or agent of any of the Target CompaniesCompany, has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body which administers Health Care LawsBody, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body Body, which administers Health Care Laws, or (iii) committed an any other act, made a any statement, or failed to make a any statement thatthat (in any such case), at the time such disclosure was made, would reasonably be expected to provide establishes a reasonable basis for the FDA or any other such Governmental Body to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy that is set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto or any similar policypolicy enforced by any comparable Governmental Body. (hf) All manufacturing operations relating to the Company Products conducted by or on behalf of Target Companies the Company with respect to any Company Product used in human clinical trials have been and are being conducted in compliance in all material respects accordance with applicable provisions of Current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B)GMP Regulations, 21 C.F.R. Parts 210 and 211, and applicable final guidance documents, as amended from time except where the failure to time. As comply would not reasonably be expected to be material to the business of the date of this AgreementCompany. Other than non-material routine or periodic inspections or reviews, there are no Company Product has been recalled, suspendedpending, or discontinued by the Target Companies at the request of the FDA or any other Governmental Body. As of the date of this Agreement, no Target Company has received any notice from the FDA or any other applicable Governmental Body that it has commenced, or, to the knowledge of the Company, threatened to initiateadverse inspections, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Product, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the production of any Company Product, except including inspectional observations (such as would not be material to the Target Companies, taken as a wholeForm FDA 483 observations). (ig) All nonclinical studies and clinical trials relating to the Company Products conducted by or on behalf of the Target Companies Company have been, or are being, conducted in compliance in all material respects with the applicable requirements of the FDA’s Good Laboratory Practice and Legal Requirements, including Good Clinical Practice requirements, including regulations under 21 C.F.R. Parts 50, 54, 56, 58, 312 and applicable guidance documentsPractices, as amended from time to time, the Animal Welfare Act, and all applicable similar Legal Requirements in other jurisdictions. To the knowledge of the Company, and all Legal Requirements relating to protection of human subjects. (j) The Target Companies there have promoted been no serious or unanticipated adverse effects associated with the Company Products in compliance in all material respects with all during clinical trials that have not been reported to any applicable Health Care Laws and other Governmental Bodies as required by applicable Legal Requirements. As Neither the FDA nor any other Governmental Body performing functions similar to those performed by the FDA has sent any written notices or other correspondence to the Company with respect to any ongoing clinical or nonclinical studies or tests requiring the termination, suspension or material modification of such studies or tests. The Company has not received any written notifications from any institutional review board, ethics committee or safety monitoring committee responsible for review, oversight or approval of any clinical trial involving a Company Product raising any material issues that require or would require the termination, suspension or investigation of, or seeking to place a clinical hold order on or otherwise delay or materially restrict any, clinical trials proposed or currently conducted by, or on behalf of, the Company, and, to the knowledge of the Company, no such action has been threatened. (h) With respect to each Company Product, the Company has provided to Parent complete and accurate copies of: (i) all clinical data pertaining to XLRP and all other material clinical, preclinical and nonclinical data with respect to any Company Product; (ii) all material written correspondence that exists as of the date of this Agreement, Agreement between the Target Companies have not received, Company and to the Company’s knowledge, do not have pending or in effect any notice, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information from the FDA or any other Governmental Body, including all meeting minutes or other records of in-person interactions with Governmental Bodies, all briefing books or other Company submissions requesting feedback from Governmental Bodies on any development program and all protocols, applications or special requests submitted to any Governmental Body concerning by the Company or its agents; (iii) all chemistry, manufacturing and controls (“CMC”) information, analytical procedures, validation reports and any other material noncompliance CMC data pertaining to XLRP and all information regarding the manufacturing facility for XLRP and the facility’s compliance with Health Care Laws GMP Regulations and all other applicable Legal Requirements and (iv) all formal and informal commitments made by the Company to any Governmental Body with regard respect to promotion any clinical trials or preclinical studies, including any long-term follow-up studies or observational studies with respect thereto. Part 2.12(h) of the Company ProductsDisclosure Schedule lists all commitments made by the Company to any Governmental Body with respect to any clinical trials or preclinical studies, including any long-term studies with respect thereto, the status of such commitments and the deadline to complete such commitment if outstanding. (ki) No Target Neither the Company, nor, to the Company’s knowledge, its officers, employees, agents or contractorscontractor of the Company, have been suspended, excluded, debarred or have been convicted of any crime or engaged in any conduct that resulted resulted, orwould reasonably be expected to result, in (i) debarment under 21 U.S.C. § 335a or any similar Legal Requirement, (ii) disqualification as a clinical investigator under 21 C.F.R. § 312.70 or any similar Health Care LawsLegal Requirement, and no Target Companies or, to or (iii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement. To the knowledge of the Company, any none of its officers, employees, agents or contractors, Collaboration Partners has engaged in activities that are prohibited under, or cause for false claim liability, civil penalties or mandatory or permissive exclusion from Medicare, Medicaid or any conduct that would reasonably be expected to result in debarment or disqualification as an investigatorother applicable Governmental Body health care program. No Target To the knowledge of the Company, nornone of its Collaboration Partners is a party to, to or bound by, any judgments, prosecution agreements, monitoring agreements or similar agreements with, or imposed by, any Governmental Body, nor is any Collaboration Partner currently the Company’s knowledge, its officers, employees, agents or contractors, has been excluded or convicted subject of any crime for which exclusion from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935investigation, as amendedmaterial review by a Governmental Body, or any similar Legal Proceeding arising under applicable Health Care Law, could resultLaws.

Compliance with Legal Requirements; Regulatory Matters. (a) Each of the Target Parent Companies is, and has during at all times in the two years prior to the date of this Agreement (if applicable) been, in compliance in all material respects with all applicable Legal Requirements, which are applicable to the business, properties, assets and activities of the Target Companies. During the two years prior to the date of this Agreement, none of the Target Parent Companies has received any written notice or, to the knowledge of the CompanyParent, any other communication from any Governmental Body or other Person regarding any actual or possible violation in any material respect of, or failure to comply in any material respect with, any Legal Requirement. (b) . Each Company Parent Product is being or has been researched, developed, tested, manufactured, packaged, labeled, handled, stored, supplied, distributed, marketed, commercialized, imported, exported, and sold in compliance in all material respects with all Health Care Laws. (c) The Company has Made Available to Parent complete and correct copies of (i) each NDA and each IND submitted to the FDA and (ii) each marketing authorization application submitted to the European Medicines Agency, in each case with respect to the Company Products, including all supplements and amendments thereto. (d) . Between December 31, 2020 2019 and the date of this Agreement, the Company Parent has not received any written communication from the FDA or any other Governmental Body, including any warning letter or untitled letter, that alleges or suggests that the Target Parent Companies are not in compliance in all material respects with any applicable requirements under the Health Care Laws. (eb) To the knowledge of the CompanyParent, as of the date of this Agreement, there are no pending or threatened material investigations, suits, claims, actions or other material Legal Proceeding against the Target CompaniesParent Companies relating to the Parent Products, including those relating to or arising under applicable Health Care Laws. Between December 31, 2020 2019 and the date of this Agreement, no Target Parent Company nor any of its officers or employees (in his or her capacity as such) has been or is subject to any enforcement proceedings by the FDA or any other Governmental Body. Between December 31, 2020 2019 and the date of this Agreement, there has not been and is not now any Form FDA 483 observation, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information pending or in effect against the Target Parent Companies or any of its officers or employees with respect to the Company Parent Products, and Target the Parent Companies have no material liability (whether actual or contingent) for failure to comply with the applicable Health Care Laws. (f) The Target Companies have maintained reasonable records relating to the research, developmentexcept, testingin each case, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products in material compliance with the applicable Health Care Laws, and the Company has submitted to the FDA and other Governmental Bodies in a timely manner all required notices and annual or other reports, including adverse experience reports and annual reports, related to the research, development, testing, manufacture, handling, labeling, packaging, storage, supply, promotion, distribution, marketing, commercialization, import, export, and sale of the Company Products, except as would not be material to the Target Parent Companies, taken as a whole. (gc) Neither any of the Target Parent Companies nor, to the knowledge of the CompanyParent, any officer, employee or agent of any of the Target Parent Companies, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Body Body, which administers Health Care Laws, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Body Body, which administers Health Care Laws, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA or any other such Governmental Body to invoke its policy respecting “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 or any similar policy. (hd) All manufacturing operations relating to the Company Parent Products conducted by or on behalf of Target Parent Companies have been and are being conducted in compliance in all material respects with applicable provisions of Current Good Manufacturing Practice requirements as set forth in 21 U.S.C. § 351(a)(2)(B), 21 C.F.R. Parts 210 and 211, and applicable final guidance documents, as amended from time to time. As of the date of this Agreement, no Company Product has been recalled, suspended, or discontinued by the Target Companies at the request of the FDA or any other Governmental Body. As of the date of this Agreement, no Target Company has received any notice from the FDA or any other applicable Governmental Body that it has commenced, or, to the knowledge of the Company, threatened to initiate, any action to withdraw approval, place sales or marketing restrictions on or request the recall of any Company Product, or that it has commenced or threatened to initiate any action to enjoin or place restrictions on the production of any Company Product, except as would not be material to the Target Companies, taken as a whole.41 (i) All nonclinical studies and clinical trials relating to the Company Products conducted by or on behalf of the Target Companies have been, or are being, conducted in compliance in all material respects with the applicable requirements of the FDA’s Good Laboratory Practice and Good Clinical Practice requirements, including regulations under 21 C.F.R. Parts 50, 54, 56, 58, 312 and applicable guidance documents, as amended from time to time, the Animal Welfare Act, and all applicable similar Legal Requirements in other jurisdictions, and all Legal Requirements relating to protection of human subjects. (je) The Target Parent Companies have promoted the Company Parent Products in compliance in all material respects with all applicable Health Care Laws and other applicable Legal Requirements. As of the date of this Agreement, the Target Parent Companies have not receivedreceived and, and to the CompanyParent’s knowledge, do not have pending or in effect any notice, civil, criminal or administrative action, suit, demand, claim, complaint, hearing, investigation, demand letter, warning letter, untitled letter, proceeding or request for information from the FDA or any Governmental Body concerning material noncompliance with Health Care Laws and other Legal Requirements with regard to promotion of Company Parent Products. . (kf) No Target Parent Company, nor, to the CompanyParent’s knowledge, its officers, employees, agents or contractors, have been debarred or have been convicted of any crime or engaged in any conduct that resulted in debarment under 21 U.S.C. § 335a or disqualification as a clinical investigator under 21 C.F.R. § 312.70 or any similar Health Care Laws, and no Target Parent Companies or, or to the knowledge of the CompanyParent, any of its officers, employees, agents or contractors, has engaged in any conduct that would reasonably be expected to result in debarment or disqualification as an investigator. No Target Parent Company, nor, to the CompanyParent’s knowledge, its officers, employees, agents or contractors, has been excluded or convicted of any crime for which exclusion from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar Health Care Law, could result.