Common use of Compliance of Products Clause in Contracts

Compliance of Products. (a) Each Loan Party: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (ii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iii) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except as set forth on Schedule 6.26(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each The Loan PartyParties represent and warrant: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in that the Borrower and its Subsidiaries possess all material respects with all reporting and regulatory requirements imposed upon it as well as Permits of the Specified Laws, including reporting to FDA and other agenciesGovernmental Authorities required for the conduct of their business as currently conducted, except where the failure to include state government agencies of product deviationsso possess could not reasonably be expected to result in a Material Adverse Effect (“Regulatory Permits”), contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting all such Regulatory Permits are in full force and effect, except where the failure to FDA of Corrections or Removals, when be in full force and as required under the FDCAeffect could not reasonably be expected to result in a Material Adverse Effect; (ii) has notthat the Borrower and its Subsidiaries have not received any written communication from any Governmental Authority regarding any failure to materially comply with any Laws or any term or requirement of any Regulatory Permit and, and to the knowledge of the Loan Parties, there are no facts or circumstances that are reasonably likely to give rise to any revocation, withdrawal, suspension, cancellation, material limitation, termination or material adverse modification of any Regulatory Permit; (iii) that none of its the officers, directors, employees, shareholdersAffiliates of the Borrower or any Subsidiary or, their agents to the Loan Parties’ knowledge, any agent or affiliates haveconsultant involved in any Drug Application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (iv) that none of the officers, directors, employees, Affiliates of the Borrower or any Subsidiary or, to the Loan Parties’ knowledge, any agent or consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Regulatory Permit from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority; (vi) that all preclinical and clinical trials conducted by or on behalf of the Borrower and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any request for a Regulatory Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols and applicable Laws; (vii) that neither the Borrower nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable LawsMaterial Adverse Effect; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least neither the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), Borrower nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2013, a Warning Letter, unresolved Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, other ,” or similar written correspondence or notice setting forth allegedly objectionable observations or alleged alleging violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority other Governmental Authority with regard to any Product or the manufacture, processing, packing, packaging or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xiix) except as set forth on Schedule 6.26(a)that, maintains since January 1, 2015, (A) there have been no Safety Notices, (B) to the Loan Parties’ knowledge, there are no unresolved material product complaints with respect to the Products which could reasonably be expected to have a Material Adverse Effect, and (C) to the Loan Parties’ knowledge, there are no facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products, or causes to be maintained (3) a policy that prevents termination or suspension of marketing of any of the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerProducts. (b) With respect to Products, the Loan Parties represent and warrant that: (i) No Loan Party has acquiredall material Products are listed on Schedule 1.01; provided, receivedthat, if after the Closing Date, the Borrower or otherwise transferred any human tissue Subsidiary wishes to manufacture, sell, develop, test or organs for valuable consideration for use in human transplantationmarket any new material Product, in violation the Borrower shall give prior written notice to the Administrative Agent of any Applicable Law.such intention (which shall include a brief description of such Product) along with a copy of an updated Schedule 1.01; (ii) Except as set forth on Schedule 6.26(b)since January 1, 2013, the operation of the business of the Borrower and its Subsidiaries with respect to each Product Product, including the manufacture, import, marketing, promotion, sale, labeling, and distribution of the Products, has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance compliance with all applicable Regulatory Permits and Applicable applicable Laws, including but except where a failure to so comply could not limited reasonably be expected to the FDCAhave a Material Adverse Effect; (iii) Without without limiting the generality of Section 6.26(a)(i6.23(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any the Borrower and its Subsidiaries, as of the Closing Date, to the Loan Party or Parties’ knowledge, neither the Borrower nor any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any written notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s the Borrower and its Subsidiaries’ manufacturing facilities and processes for manufacturing such Product or the marketing and sales of such Product, in each case which have disclosed identified any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Regulatory Permits related to the manufacture manufacture, marketing and/or sales of such ProductProduct that could reasonably be expected to result in a Material Adverse Effect, or (B) any such Required Regulatory Permit that could be reasonably expected to result in a revocation or that any withdrawal of such Required Permit has been revoked or withdrawnRegulatory Permit, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) abovetesting, with respect to any Product marketedmanufacturing, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product by the Borrower and its Subsidiaries should cease or that such Product should be withdrawn from the marketplace; and; (viv) between October 21, 2015 and the Loan Parties and their Subsidiaries have not Closing Date, neither the Borrower nor any Subsidiary has experienced any significant failures in their the manufacturing of any Product for commercial sale that has had or could reasonably be expected to have, if such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior monthfailure occurred again, a Material Adverse Effect. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Party: (i) has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all applicable Laws including the Specified Laws, and all such Required Permits are current and each holder of such Required Permits is in material compliance with the terms and conditions of all such Required Permits; (ii) except as set forth on Schedule 6.26(a5.30(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (iiiii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiiv) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required PermitsPermit; (ivv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (vvi) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawLaw; (vivii) is in material compliance with all Environmental Laws; (viiviii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable applicable regulations and Laws; (viiiix) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (Cagents;(C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ixx) except as set forth on Schedule 6.26(a5.30(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (xxi) [reserved]; (xii) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable applicable regulations and Laws and such Transport and Disposal Agreement remains in full force and effect; and (xixiii) except as set forth on Schedule 6.26(a5.30(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Schedule 5.30(b), hereto lists all Required Permits issued by a Governmental Authority relating to a Product and/or the applicable Loan Party’s manufacture, sale, development, testing or marketing thereof maintained by Loan Parties as of the ClosingSecond Amendment Effective Date, together with the applicable Product category corresponding to the Required Permits. Loan Parties have delivered to the Administrative Agent on or prior to the ClosingSecond Amendment Effective Date copies of all such Required Permits. If, after the ClosingSecond Amendment Effective Date, any Loan Party acquires or renews any Required Permit issued by a Governmental Authority relating to a Product and/or the applicable Loan Party’s manufacture, sale, development, testing or marketing thereof issued, Loan Parties shall promptly deliver a copy of such new or renewed Required Permit along with a copy of an update to Schedule 5.30(b); (iii) Except as set forth on Schedule 6.26(b5.30(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiiiv) Without limiting the generality of Section 6.26(a)(i5.30(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law applicable Laws (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (ivv) Without limiting the generality of Section 6.26(a)(i5.30(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vvi) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Credit Party: (i) except as set forth on Schedule 6.26(a)has obtained all Required Permits, or has been operating in contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAall such Required Permits are current; (ii) has notnot used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a (a) or (b); (iii) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates havehas been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a (a) or authorized by 21 U.S.C. Section 335a (b); (iv) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation Register 46191 (September 10, 1991); (iiiv) has not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Loan Credit Party, or any of its their officers, directors, employees, shareholders, shareholders or their agents or and Affiliates, from conducting their respective businesses at any facility owned or used by any of them, them or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a)3.11, has not received from the FDA or the DEA, at any time warning letterssince January 1, 2003, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDAFDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xivii) except as set forth on Schedule 6.26(a)3.11, maintains has not engaged in any Recalls, Market Withdrawals, or causes to be maintained a policy that prevents other forms of product retrieval from the exposure marketplace of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerany Products since January 1, 2003. (b) None of the Credit Parties, their Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. No Credit Party nor, to the knowledge of any Credit Party, any of its Affiliates or agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law. (c) With respect to Products: (i) No Loan Party has acquiredAll Products are listed on the attached Products Schedule and Borrowers have delivered to Administrative Agent on or prior to the Closing Date all Required Permits relating to such Products issued or outstanding as of the Closing Date; provided, receivedhowever, that, if after the Closing Date, any Borrower wishes to manufacture, sell, develop, test or market any new Product, Borrowers shall give prior written notice to Administrative Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an amended and restated the attached Products Schedule; and further, provided, that, if any Borrower shall at any time obtain any new or additional Required Permits from the FDA, DEA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, DEA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Administrative Agent, Borrowers shall promptly give written notice to Administrative Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except as set forth on Schedule 6.26(b3.11, each Product is not adulterated or misbranded within the meaning of the FDCA; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (iv) Each Product that is sold pursuant to a Credit Party’s belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses; (v) Each Product for which a Drug Efficacy Study Implementation (DESI) Notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth in such DESI Notice; (vi) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCALaws in all material respects; (iiivii) Each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices in all material respects; (viii) Without limiting the generality of Section 6.26(a)(i3.11(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan PartyBorrower, such Person has Borrowers have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such PersonBorrower, and such Person has Borrowers have not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s Borrowers’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Lawslaws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person Borrower should cease; (ivix) Without limiting the generality of Section 6.26(a)(i3.11(a)(i) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party or any Subsidiary of any Loan PartyBorrower, such Person Borrowers shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such PersonBorrower, and such Person has Borrowers have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vx) the Loan Parties and their Subsidiaries Borrowers have not (since the Closing Date) experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them Borrowers in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Credit Party: (i) except as set forth on Schedule 6.26(a)has obtained all Required Permits, or has been operating in contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAall such Required Permits are current; (ii) has notnot used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a (a) or (b); (iii) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates havehas been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a (a) or authorized by 20 X.X. Xxxxxxx 000x (b); (iv) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) has not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Loan Credit Party, or any of its their officers, directors, employees, shareholders, shareholders or their agents or and Affiliates, from conducting their respective businesses at any facility owned or used by any of them, them or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a)3.12, has not received from the FDA or the DEA, at any time warning letterssince January 1, 2003, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDAFDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xivii) except as set forth on Schedule 6.26(a)3.12, maintains has not engaged in any Recalls, Market Withdrawals, or causes to be maintained a policy that prevents other forms of product retrieval from the exposure marketplace of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerany Products since January 1, 2003. (b) None of the Credit Parties, their Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. No Credit Party nor, to the knowledge of any Credit Party, any of its Affiliates or agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law. (c) With respect to Products: (i) No Loan Party has acquiredAll Products are listed on Exhibit F and Borrowers have delivered to Agent on or prior to the Closing Date all Required Permits relating to such Products issued or outstanding as of the Closing Date; provided, receivedhowever, that, if after the Closing Date, any Borrower wishes to manufacture, sell, develop, test or market any new Product, Borrowers shall give prior written notice to Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an amended and restated Exhibit F; and further, provided, that, if Borrower shall at any time obtain any new or additional Required Permits from the FDA, DEA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, DEA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Agent, Borrower shall promptly give written notice to Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except Each Product is not adulterated or misbranded within the meaning of the FDCA; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (iv) Each Product that is sold pursuant to a Credit Party’s belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses; (v) Each Product for which a Drug Efficacy Study Implementation (DESI) Notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth on Schedule 6.26(b), each in such DESI Notice; (vi) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiivii) Each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices; (viii) Without limiting the generality of Section 6.26(a)(i3.12(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan PartyBorrower, such Person Borrower has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such PersonBorrower, and such Person has Borrowers have not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s Borrowers’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Lawslaws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person Borrower should cease; (ivix) Without limiting the generality of Section 6.26(a)(i3.12(a)(i) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party or any Subsidiary of any Loan PartyBorrower, such Person Borrower shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such PersonBorrower, and such Person has Borrowers have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vx) the Loan Parties and their Subsidiaries Borrowers have not (since the Closing Date) experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them Borrower in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Credit Party: (i) except as set forth on Schedule 6.26(a)has obtained all Required Permits, or has been operating in contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAall such Required Permits are current; (ii) has notnot used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a (a) or (b); (iii) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates havehas been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a (a) or authorized by 20 X.X. Xxxxxxx 000x (b); (iv) warrants and represents that none of its officers, directors, employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) has not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Loan Credit Party, or any of its their officers, directors, employees, shareholders, shareholders or their agents or and Affiliates, from conducting their respective businesses at any facility owned or used by any of them, them or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a)3.25, has not received from the FDA or the DEA, at any time warning letterssince January 1, 2003, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDAFDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xivii) except as set forth on Schedule 6.26(a)3.25, maintains has not engaged in any Recalls, Market Withdrawals, or causes to be maintained a policy that prevents other forms of product retrieval from the exposure marketplace of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerany Products since January 1, 2003. (b) None of the Credit Parties, their Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. No Credit Party nor, to the knowledge of any Credit Party, any of its Affiliates or agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law. (c) With respect to Products: (i) No Loan Party has acquiredAll Products are listed on Exhibit F and Borrowers have delivered to Administrative Agent on or prior to the Closing Date all Required Permits relating to such Products issued or outstanding as of the Closing Date; provided, receivedhowever, that, if after the Closing Date, any Borrower wishes to manufacture, sell, develop, test or market any new Product, Borrowers shall give prior written notice to Administrative Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an amended and restated Exhibit F; and further, provided, that, if Borrower shall at any time obtain any new or additional Required Permits from the FDA, DEA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, DEA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Administrative Agent, Borrower shall promptly give written notice to Administrative Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except Each Product is not adulterated or misbranded within the meaning of the FDCA; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (iv) Each Product that is sold pursuant to a Credit Party’s belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses; (v) Each Product for which a Drug Efficacy Study Implementation (DESI) Notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth on Schedule 6.26(b), each in such DESI Notice; (vi) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiivii) Each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices; (viii) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan PartyBorrower, such Person Borrower has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such PersonBorrower, and such Person has Borrowers have not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s Borrowers’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Lawslaws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person Borrower should cease; (ivix) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party or any Subsidiary of any Loan PartyBorrower, such Person Borrower shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such PersonBorrower, and such Person has Borrowers have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vx) the Loan Parties and their Subsidiaries Borrowers have not (since the Closing Date) experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them Borrower in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each The Loan PartyParties represent and warrant: (i) except as set forth on Schedule 6.26(a)that the Borrower and its Subsidiaries have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Laws, including reporting failure to FDA and other agencies, do so could not reasonably be expected to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAresult in a Material Adverse Effect; (ii) has notthat the Borrower and its Subsidiaries have not received any communication from any Governmental Authority regarding, and there are no facts or circumstances that are likely to give rise to (A) any material adverse change in any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit; (iii) that none of its the officers, directors, employees, shareholders, their agents agents, Affiliates of the Borrower or affiliates haveany Subsidiary or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant involved in any Product application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (iv) that none of the officers, directors, employees, shareholders, agents, Affiliates of the Borrower or any Subsidiary or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. The Required Permits issued by the FDA and other Governmental Authorities for the Borrower’s and its Subsidiaries’ products are valid and supported by proper research, design, testing, analysis and disclosure; (vi) that all preclinical and clinical trials in respect of the activities of the Borrower and its Subsidiaries being conducted by or on behalf of the Borrower and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (vii) that neither the Borrower nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable LawsMaterial Adverse Effect; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Lawsthat, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a)6.25, neither the Borrower nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2008, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishmentswith regard to any Product or the manufacture, processing, packaging or holding thereof, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xiix) that, except as set forth on Schedule 6.26(a6.25, neither the Borrower nor any Subsidiary (A) has engaged in any Recalls, field notifications, Market Withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance of the Products issued by the Borrower or any Subsidiary, any clinical investigator, and/or other third party (“Safety Notices”), maintains (B) has knowledge of any material product complaints with respect to the Products which, if true, could reasonably be expected to have a Material Adverse Effect, and (C) has knowledge of any facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products, or causes to be maintained (3) a policy that prevents termination or suspension of developing and testing of any of the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerProducts. (b) With respect to Products, the Loan Parties represent and warrant that: (i) No Loan Party all Products are listed on Schedule 1.01 and the Borrower has acquireddelivered to the Administrative Agent on or prior to the Closing Date copies of all Required Permits relating to such Products issued or outstanding as of the Closing Date; provided, receivedthat, if after the Closing Date, the Borrower or any Subsidiary wishes to manufacture, sell, develop, test or market any new Product, the Borrower shall give prior written notice to the Administrative Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the Borrower or such Subsidiary’s manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an updated Schedule 1.01; and provided, further, that, if the Borrower and/or any Subsidiary shall at any time obtain any new or additional Required Permits from the FDA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Administrative Agent, the Borrower shall promptly give written notice to Administrative Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except as set forth on Schedule 6.26(b)each Product is not adulterated or misbranded within the meaning of the FDCA, except where a failure of a Product so to comply could not reasonably be expected to have a Material Adverse Effect; (iii) each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA, except where such introduction of a prohibited Product could not reasonably be expected to have a Material Adverse Effect; (iv) each Product has been and/or and shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but except where a failure to do so could not limited reasonably be expected to the FDCAhave a Material Adverse Effect; (iiiv) Without each Product has been and shall be manufactured in accordance with customary manufacturing practices, except where a failure to do so could not reasonably be expected to have a Material Adverse Effect; (vi) without limiting the generality of Section 6.26(a)(i6.25(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Partythe Borrower and its Subsidiaries, such Person has the Borrower and its Subsidiaries have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of the Borrower or such PersonSubsidiary, and such Person and, to the Borrower’s knowledge, neither the Borrower nor any Subsidiary has not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s the Borrower and its Subsidiaries’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or or manufacturing of such Product by such Person the Borrower and its Subsidiaries should cease; (ivvii) Without without limiting the generality of Section 6.26(a)(i6.25(a)(i) and (ii) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party the Borrower or any Subsidiary of any Loan Partyits Subsidiaries, such Person the Borrower and its Subsidiaries shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Personthe Borrower and its Subsidiaries, and such Person and, to the Borrower’s knowledge, neither the Borrower nor any Subsidiary has not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vviii) neither the Loan Parties and their Subsidiaries have not Borrower nor any Subsidiary has experienced any significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them the Borrower or any of its Subsidiaries in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan PartyExcept where the failure to do so could not reasonably be expected to result, either individually or in the aggregate, in a Material Adverse Effect: (i) except as set forth on Schedule 6.26(a)the Borrower and its Subsidiaries, has been operating in either directly or through its Product Distributors, have obtained all Regulatory Authorizations necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA all such Regulatory Authorizations are in full force and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAeffect; (ii) has notall Regulatory Authorizations held by the Loan Parties, either directly or indirectly through their respective Subsidiaries and Product Distributors, are (A) legally and beneficially owned exclusively by one of the Loan Parties or their respective Subsidiaries or Product Distributors, free and clear of all Liens other than Permitted Liens, and none (B) validly granted by and/or registered and on file with the applicable Regulatory Agency, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Regulatory Agency; and (iii) all required notices, registrations and listings, supplemental applications or notifications, reports (including reports of its officersadverse experiences) and other required filings with respect to the Products have been filed with the FDA, directorsthe DEA, employeesthe EMA and all other applicable Regulatory Agencies when due. (b) Except where the failure to do so could not reasonably be expected to result in the termination or material restriction of a Material Regulatory Authorization, shareholdersall applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Regulatory Authorization from the FDA, EMA, or other Regulatory Agency relating to the Borrower or any Subsidiary or any of their agents respective business operations and Products, when submitted to the FDA, EMA, or affiliates haveother Regulatory Agency were true, made an complete and correct in all material respects as of the date of submission (including any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data that have been submitted to the FDA, EMA, or other Regulatory Agency). The Regulatory Authorizations issued by the FDA, EMA, and other Regulatory Agencies for the Products are valid and supported by proper research, design, testing, analysis and disclosure, except where the failure to do so could not reasonably be expected to result, either individually or in the aggregate, in a Material Adverse Effect. There has been no material untrue statement of material fact or and/or no fraudulent statement made by the Loan Parties or their respective Subsidiaries or, to the FDA knowledge of the Loan Parties, Product Distributors (as relating to Products), or failed any of their respective agents or representatives to the FDA, the DEA, the EMA or any other Regulatory Agency, and there has been no failure to disclose a any material fact required to be disclosed disclosed, commission of an act, making of a statement, or failure to make a statement to the FDA, committed an actthe DEA, made a statement, the EMA or failed to make a statement any other Regulatory Agency that could 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. Regulation 46191 (September 10, 1991). (c) Except as could not reasonably be expected to result in a Material Adverse Effect, either individually or in the aggregate: (i) The Loan Parties, their respective Subsidiaries and, to the knowledge of the Borrower, their Product Distributors (as relating to Products), materially comply with (A) all applicable Laws, rules, regulations, orders, injunctions and decrees of the FDA, the DEA, the EMA and any other applicable Regulatory Agency, including, without limitation, all applicable requirements of the FDCA, the Controlled Substances Act, similar state Laws and similar Laws of any country, jurisdiction or Governmental Authority other than the United States, and (B) all applicable Product Authorizations, Regulatory Authorizations and all other Permits; (ii) None of the Loan Parties, their respective Subsidiaries nor their respective Product Distributors or suppliers have received and do not otherwise have knowledge of: any inspection reports, warning letters, untitled letters or similar documents with respect to any of their Products or any of their Product Development and Commercialization Activities or the manufacturing, processing, packing, distribution or holding activities thereof, as well as the business of the Loan Parties and their respective Subsidiaries or relevant Product Distributors, from any Regulatory Agency that assert lack of compliance with any applicable Laws, rules, regulations, orders, injunctions, or decrees; (iii) None of the Loan Parties, their respective Subsidiaries nor, to the knowledge of the Borrower, their respective Product Distributors or suppliers have received any written notice of, and does not otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry (other than non-material routine or periodic inspections or reviews) against the Loan Parties, any of their respective Subsidiaries or any of their respective Product Distributors or suppliers with respect to any of their Products or any of their Product Development and Commercialization Activities, and, to the knowledge of the Borrower, there is no basis for any adverse regulatory action against the Loan Parties or their respective Subsidiaries or, to the knowledge of the Borrower, their respective Product Distributors or suppliers with respect to the Products; and (iv) Without limiting the foregoing, (A) to the knowledge of the Borrower, no Product Distributor or supplier of any Loan Party or any Subsidiary has received, during the two (2) years prior to the Closing Date, any Form FDA 483 from the FDA asserting a lack of compliance with respect to any Products or Product Development and Commercialization Activities therefor, (B) to the knowledge of the Borrower (1) there have been no Safety Notices conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Regulatory Agency or otherwise, with respect to any Products or Product Development and Commercialization Activities, (2) no Safety Notice has been requested, demanded or ordered by any Regulatory Agency, and, to the knowledge of the Borrower, there is no basis for the issuance of any Safety Notice by any Person with respect to any Products or Product Development and Commercialization Activities, and (C) the Loan Parties have not received any written notice of, and do not otherwise have knowledge of, any criminal, injunctive, seizure, detention or civil penalty actions that have at any Governmental Authoritytime been commenced or threatened in writing by any Regulatory Agency with respect to or in connection with any Products or Product Development and Commercialization Activities, or any consent decrees (including plea agreements) which relate to any Products or Product Development and Commercialization Activities, and, to the knowledge of the Borrower, there is no basis for the commencement of any criminal injunctive, seizure, detention or civil penalty actions by any Regulatory Agency relating to any Products or Product Development and Commercialization Activities or for the issuance of any consent decrees. None of the Loan Parties or their respective Subsidiaries nor, to the knowledge of the Borrower, any of their respective Product Distributors or suppliers is employing or utilizing the services of any individual who is associated with the introduction of misbranded or adulterated Products into interstate commerce or who has been convicted of any crime or engaged in any conduct for which debarment or temporary suspension under any applicable Law, rule or regulation is warranted. (d) Except as could not reasonably be expected to result, either individually or in the aggregate, in a Material Adverse Effect, none of the Loan Parties or their respective Subsidiaries nor, to the knowledge of the Borrower, any Product Distributors (as relating to Products) has received any communication from any Regulatory Agency regarding, and there are no facts or circumstances that are likely to give rise to, (i) any material adverse change in any applicable Regulatory Authorization, or any failure to materially comply with any Laws or any term or requirement of any applicable Regulatory Authorization or (ii) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any applicable Regulatory Authorization. (e) Except as could not reasonably be expected, either individually or in the aggregate, to result in a in a Material Adverse Effect, all studies, tests, preclinical trials and clinical trials conducted by or on behalf of or for the benefit of any Loan Party or any of its respective Subsidiaries with respect to any Product have been conducted in material compliance with applicable Laws, including cGCPs. No Loan Party nor any of their respective Subsidiaries has received any notice from the FDA, EMA, or any other Regulatory Agency alleging any material non-compliance with applicable Laws, including cGCPs or otherwise terminating or suspending any clinical trial conducted by or on behalf of or for the Office benefit of such Loan Party or Subsidiary with respect to any Product. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Administrative Agent. The summaries and descriptions of any of the Inspector General foregoing provided to the Administrative Agent are accurate and contain no material omissions. None of HHSthe Loan Parties, their respective Subsidiaries, or, to the United States Department knowledge of Justice the Borrower, any of their respective Product Distributors, licensees, licensors or any equivalent foreign agencythird party services providers or consultants, has commenced received from the FDA, EMA, or threatened other applicable Regulatory Agency any notices or correspondence requiring the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials in any material respect with respect to or in connection with the Products. (f) Except as could not reasonably be expected, either individually or in the aggregate, to result in a Material Adverse Effect: (A) all design, manufacturing, storage, distribution, packaging, labeling, sale, recordkeeping and other activities by the Loan Parties, their respective Subsidiaries and their respective Product Distributors and suppliers relating to the Products have been conducted, and are currently being conducted, in compliance with applicable Laws and the requirements of all applicable Regulatory Agencies, including, without limitation, cGMPs, adverse event reporting requirements, and state and federal requirements relating to the handling of controlled substances and (B) none of the Loan Parties or their respective Subsidiaries, or, to the knowledge of the Borrower, any of their respective Product Distributors and suppliers has received written notice or has knowledge of a threat of commencement of action by any Governmental Authority to initiate any action against the Borrower or any Subsidiary, any action to enjoin a Loan Party, the Borrower or any of Subsidiary, its officers, directors, employees, shareholders, or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result ; (ii) no Product in the revocationinventory of the Loan Parties or their respective Subsidiaries or, transferto the knowledge of the Borrower, surrender, suspension or other material impairment of any Product Distributor is adulterated or misbranded; (iii) all labels and labeling (including package inserts) and product information are in material portion compliance with applicable FDA, EMA, and other Regulatory Agency requirements, and the Products are in material compliance with all classification, registration, listing, marking, tracking, reporting, recordkeeping and audit requirements of the Required PermitsFDA, the DEA, the EMA, and any other Regulatory Agency; (iv) no Product is not a participant in any federal program whereby any federalan article prohibited from introduction into interstate commerce under the provisions of Sections 404, state 505 or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason 512 of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (iig) Except as set forth on Schedule 6.26(b)could not reasonably be expected, each Product has been and/or shall be manufacturedeither individually or in the aggregate, importedto result in a Material Adverse Effect, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited manufacturing facilities used to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to manufacture any Product being tested owned or manufactured operated by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their respective Subsidiaries and, to the knowledge of the Borrower, of any Product Distributor (as relating to Products): (x) are and have been operated in material compliance with cGMPs and all other applicable Laws, and (y) all such facilities are operated in material compliance with the Controlled Substances Act, applicable DEA regulations, and other applicable federal and state Laws. No Form 483, warning letter, or untitled letter has been issued, and no other allegation of any material non-compliance with cGMPs has been made with respect to any such facility. (h) The Loan Parties have made available to the Administrative Agent all material adverse event reports and material communications to or from the FDA, EMA and other relevant Regulatory Agencies, including material inspection reports, warning letters, untitled letters, and material reports, studies and other correspondence, other than opinions of counsel that are attorney-client privileged, with respect to regulatory matters relating to the Loan Parties and their respective Subsidiaries, the conduct of their business, the operation of any manufacturing Facilities owned or operated by the Loan Parties and their respective Subsidiaries, and the Products, in each case, to the extent that the events or circumstances underlying such report or communication either had a Material Adverse Effect or could reasonably be expected to have a Material Adverse Effect. (i) Except as could not experienced any reasonably be expected, either individually or in the aggregate, to result in a in a Material Adverse Effect, there have been no significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them or on behalf of the Borrower or any Subsidiary in accordance with all specifications thereof and any required payments the Regulatory Authorizations related thereto in any month shall decrease significantly have been insufficient to meet all obligations associated with respect to the quantities of Product Development and Commercialization Activities associated with such Product produced in the prior monthProduct. (cj) Neither Except as could not reasonably be expected, either individually or in the execution nor performance by aggregate, to result in a in a Material Adverse Effect, none of the Products is currently, and have not for the past four (4) years, the subject of any claim or allegation, formal or informal, that any Product, or its use, is defective or has resulted in or proximately caused any injury to any Person or property. (k) No Loan Party nor any of their respective Subsidiaries or, to the knowledge of the Borrower, any relevant Product Distributor engaged in Product Development and Commercialization Activities has received any material notice from the United States Department of Justice, any U.S. Attorney, any State Attorney General, or other similar federal, state, or foreign Governmental Authority alleging any violation of the Federal Anti-kickback Statute, the Federal False Claims Act, any federal Law, or state or foreign Law. No Loan Party nor any of their respective Subsidiaries has knowledge of any Loan Documents, nor the exercise conduct that reasonably could be interpreted as a material violation of any remedies such Law. (l) The transactions contemplated by the Loan Documents will not (i) constitute a breach or violation of, or otherwise materially affect, the enforceability or approval of any party thereunderMaterial Regulatory Authorization relating to any Product or (ii) impair the Loan Parties’ ownership of or rights under (or the license or other right to use, as the case may be) any Material Regulatory Authorizations relating to any Product in any material manner. (m) The exercise by the Administrative Agent or the Secured Parties of any right or protection set forth in the Loan Documents will adversely affect any of not (i) constitute a breach or violation of, or otherwise materially affect, the Required Permits.enforceability or approval of

Compliance of Products. (a) Each Loan PartyThe Borrower and its Subsidiaries: (i) except as set forth on Schedule 6.26(a)have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws with respect to sourcing, manufacturing, development, testing, production, sale and regulatory requirements imposed upon it as well as the Specified Lawsdistribution of Products, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths all such Required Permits are in full force and reporting to FDA of Corrections or Removals, when and as required under the FDCAeffect; (ii) has nothave not received any adverse written communication from any Governmental Authority regarding, and there are no facts or circumstances that are likely to give rise to (A) any material adverse change in, any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit; (iii) have not used the services of any Person debarred or disqualified under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a; (iv) warrant and represent that none of its their officers, directors, nor, to the Borrower's Knowledge, any of their employees, shareholdersagents, Affiliates or any consultant involved in any Drug Application, has been convicted of any felony for which debarment or disqualification is authorized by 21 U.S.C. Section 335a or engaged in any other action for which debarment or disqualification is authorized by 21 U.S.C. Section 335a; (v) warrant and represent that, none of their agents officers, directors, nor, to the Borrower’s Knowledge, any of their employees, agents, Affiliates or affiliates have, any consultant has made on behalf of the Borrower an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiivi) has warrant and represent that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority; (vii) warrant and represent that all preclinical and clinical trials in respect of the activities of the Borrower and its Subsidiaries being conducted by or on behalf of the Borrower and its Subsidiaries producing data submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (viii) have not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agencyJustice, has commenced or threatened to initiate any enforcement action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCPMaterial Adverse Effect; (ix) except as set forth on Schedule 6.26(a), neither the Borrower nor any Subsidiary has not received from the FDA at any time warning lettersor the DEA, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations for correction (except with respect to observations and violations which could not reasonably be expected to have a Material Adverse Effect) or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority FDA with regard to any Product or the manufacture, processing, packing, or holding thereof;; and (x) neither the Borrower nor any Subsidiary has entered into (A) instituted any Recalls or Market Withdrawals, (B) issued or received any Safety Notices, (C) Knowledge of any material product complaints with respect to the Products, to the extent that any such matter could reasonably be expected to have a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerMaterial Adverse Effect. (b) With respect to Products: (i) No Loan Party has acquiredAll Products are listed on Schedule 1.01; provided, receivedthat, if after the Closing Date, the Borrower or otherwise transferred any human tissue Subsidiary wishes to sell or organs for valuable consideration for use in human transplantationmarket any new Product, in violation of any Applicable Law.the Borrower shall update Schedule 1.01 to include such Product; (ii) Except as set forth on Schedule 6.26(b)Each Product is not adulterated or misbranded within the meaning of the FDCA; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, each 505 or 512 of the FDCA; (iv) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but except where a failure to do so could not limited reasonably be expected to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplacea Material Adverse Effect; and (v) the Loan Parties Each Product has been and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully shall be manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect good manufacturing practices, except where a failure to the quantities of such Product produced in the prior monthdo so could not reasonably be expected to have a Material Adverse Effect. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each The Loan PartyParties represent and warrant: (i) except as set forth on Schedule 6.26(a)that the Borrower and its Subsidiaries have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Laws, including reporting failure to FDA and other agencies, do so could not reasonably be expected to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAresult in a Material Adverse Effect; (ii) has notthat the Borrower and its Subsidiaries have not received any communication from any Governmental Authority regarding, and are not aware of any facts or circumstances that are likely to give rise to (A) any material adverse change in any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit; (iii) that none of its the officers, directors, employees, shareholdersstockholders, their agents agents, Affiliates of the Borrower or affiliates haveany Subsidiary or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant involved in any Product application, has been convicted of any crime or engaged in any conduct which could reasonably be expected to result in debarment under 21 U.S.C. Section 335a; (iv) that none of the officers, directors, employees, stockholders, agents, Affiliates of the Borrower or any Subsidiary or, to the Borrower’s knowledge, any consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. The Required Permits issued by the FDA and other Governmental Authorities for the Borrower’s and its Subsidiaries’ Products are valid and supported by proper research, design, testing, analysis and disclosure; (vi) that all preclinical and clinical trials in respect of the activities of the Borrower and its Subsidiaries being conducted by or on behalf of the Borrower and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (vii) that neither the Borrower nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, stockholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable LawsMaterial Adverse Effect; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least that neither the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), Borrower nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2008, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishmentswith regard to any Product or the use, manufacture, processing, packaging or holding thereof, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the use, manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xiix) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents neither the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except as set forth on Schedule 6.26(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or Borrower nor any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed has engaged in any material deficiencies recalls, field notifications, Market Withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or violations other notice of Applicable Law action relating to an alleged lack of safety or regulatory compliance of the Products issued by the Borrower or any Subsidiary, any clinical investigator, and/or other third party (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product“Safety Notices”), or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary knowledge of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly material product complaints with respect to the quantities of such Product produced in the prior month. Products which, if true, could reasonably be expected to have a Material Adverse Effect and (cC) Neither the execution nor performance by any Loan Party has knowledge of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.facts that would be reasonably likely to result in (1)

Compliance of Products. (a) Each Loan PartyBorrower and each Subsidiary: (i) except as set forth on Schedule 6.26(a)has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all Laws including the Specified Laws, and all such Required Permits are current and each holder of such Required Permits is in material compliance with the terms and conditions of all such Required Permits; (ii) has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (iiiii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiiv) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Credit Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required PermitsPermit; (ivv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (vvi) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws laws or regulations, or (C) made a party to any other action by any Governmental Authority governmental authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawLaw; (vivii) is in material compliance with all Environmental Laws; (viiviii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable applicable regulations and Laws; (viiiix) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, Laws and customary business practices for each Loan Party Borrower which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (Cagents;(C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ixx) except as set forth on Schedule 6.26(a3.25(a)(x), has not received from the FDA at any time warning lettersWarning Letters, Form FDA-483 inspection reports, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (xxi) except as set forth on Schedule 3.25(a)(xi), has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products at any time; (xii) has entered into, or will enter into a Transport and Disposal Agreement as required, an agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable applicable regulations and Laws and such Transport and Disposal Agreement remains in full force and effect; and; (xixiii) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner; (b) Parent and BioHorizons each hereby represents and warrants, in addition to Section (a)(i) through (xiii) that it; (i) has implemented or is causing to be implemented all corrective actions agreed to in response to observations and/or deficiencies noted in any inspection or audit by any Governmental Authority or other licensing organization at each respective facility including but not limited to all corrective actions outlined in the response to the FDA Warning letter issued to BioHorizons Implant Systems, Inc. on December 27, 2004 and to address any deficiencies raised in the FDA 483 Inspectional Observations issued to BioHorizons on August 18, 2006; (ii) conducts sufficient and regular internal quality audits, evaluations of suppliers/contractors, and conducts management review meetings at regularly defined intervals in compliance with Specified Laws; (iii) has implemented a procedure to conduct follow-up investigations to maintain full documentation of each batch of finished devices to meet applicable acceptable criteria before release for distribution in accordance with Specified Laws; (iv) has implemented a procedure to conduct follow-up investigations to complaints involving the failure of devices to meet specifications and documents the reasons for the lack of investigations if none are undertaken, and that such procedure provides for the complete review and evaluation of complains and that all complaints received are processed in a uniform and timely matter and in compliance with Specified Laws; (v) has implemented a procedure to conduct and document adequate corrective and preventive actions in response to complaints involving the failure of medical devices to meet specifications in compliance with the requirements of Specified Laws; (vi) has implemented a procedure for validation and verification of design changes prior to implementation of such changes in compliance with Specified Laws; (vii) has ensured that the medical device reporting procedure within the company’s internal systems provides for timely transmission of complete medical device reports to FDA in compliance with Specified Laws; and (viii) has taken all such actions necessary to ensure the hiring of adequate staff to perform regulatory functions and that all individuals holding responsibility for regulatory functions, in a management or supervisory capacity, possess the requisite experience, training and certifications to carry out their job responsibilities. (bc) With respect to Products: (i) No Loan Party Borrower or any Subsidiary of any Borrower has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except Schedule 3.25(c)(ii) hereto lists all Required Permits issued by a Governmental Authority in North America relating to a Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof maintained by Borrowers as set forth of the Closing Date, together with the applicable Product category corresponding to the Required Permits. Borrowers have delivered to Administrative Agent on or prior to the Closing Date copies of all such Required Permits. If, after the Closing Date, any Borrower acquires or renews any Required Permit issued by a Governmental Authority in North America relating to a Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof issued, such Borrower shall promptly deliver a copy of such new or renewed Required Permit along with a copy of an amended and restated Schedule 6.26(b3.25(c)(ii), ; (iii) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiiiv) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party Borrower or any Subsidiary of any Loan PartyBorrower, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Government Authority, including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Lawshealthcare laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (ivv) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party Borrower or any Subsidiary of any Loan PartyBorrower, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vvi) the Loan Parties Borrowers and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (cd) Parent and BioHorizons each hereby represent and warrant, in addition to Section (c)(i) through (vi) that, with respect to Products: (i) Each Product commercially distributed within the past 12 months is not adulterated or misbranded within the meaning of the FDCA; (ii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 510(k) or 515 of the FDCA; (iii) Each Product has been and/or shall be designed and manufactured in accordance with Good Manufacturing Practice as defined in the Quality System Regulation 21 C.F.R. Part 820; (e) Neither the execution nor performance by any Loan Party Borrower or any of its Subsidiaries of any Loan Financing Documents or other Operative Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Borrower and each other Credit Party: (i) except as set forth on Schedule 6.26(a4.30(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (ii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iii) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Credit Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required PermitsHealthcare Authorization; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority governmental authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawLaw; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable applicable regulations and Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a4.30(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws Laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof;] (ix) except as set forth on Schedule 4.30(a), has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products at any time; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable applicable regulations and Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a4.30(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Borrower or other Credit Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law.; (ii) Except Schedule 4.30(b), hereto lists all Healthcare Authorizations issued by a Governmental Authority relating to a Product and/or the applicable Borrower’s or other Credit Party’s manufacture, sale, development, testing or marketing thereof maintained by Borrowers and other Credit Parties as of the Closing Date, together with the applicable Product category corresponding to the Healthcare Authorizations. Each Borrower and each other Credit Party has delivered to Administrative Agent on or prior to the Closing Date copies of all such Healthcare Authorizations. If, after the Closing Date, any Borrower or any other Credit Party acquires or renews any Healthcare Authorization issued by a Governmental Authority relating to a Product and/or the applicable Borrower’s or Credit Party’s manufacture, sale, development, testing or marketing thereof issued, Borrowers shall promptly deliver a copy of such new or renewed Healthcare Authorization along with a copy of an update to Schedule 4.30(b); (iii) except as set forth on Schedule 6.26(b4.30(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits Healthcare Authorizations and Applicable Laws, including but not limited to the FDCA; (iiiiv) Without without limiting the generality of Section 6.26(a)(i) above4.20, with respect to any Product being tested or manufactured by any Loan Party Borrower or any Subsidiary of any Loan other Credit Party, such Person Borrower or Credit Party has received, and such Product shall be the subject of, all Required Permits Healthcare Authorizations needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such PersonBorrower or Credit Party, and such Person Borrower or Credit Party has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such PersonBorrower’s or Credit Party’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Laws) and/or the Required Permits Healthcare Authorizations related to the manufacture of such Product, or (B) any such Required Permit Healthcare Authorizations or that any such Required Permit Healthcare Authorization has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person Borrower or Credit Party should cease; (ivv) Without without limiting the generality of Section 6.26(a)(i) above4.20, with respect to any Product marketed, leased, rented, or sold by any Loan Party Borrower or any Subsidiary of any Loan other Credit Party, such Person Borrower or Credit Party shall have received, and such Product shall be the subject of, all Required Permits Healthcare Authorizations needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such PersonBorrower or Credit Party, and such Person Borrower or Credit Party has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit Healthcare Authorization or approval or that any such Required Permit Healthcare Authorization has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vvi) the Loan Parties and their Subsidiaries have not No Borrower or any other Credit Party has experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them it in accordance with all specifications thereof and any required payments the Healthcare Authorizations related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Borrower or any other Credit Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required PermitsHealthcare Authorizations.

Compliance of Products. (a) Each The Loan PartyParties represent and warrant: (i) except as set forth on Schedule 6.26(a)that the Loan Parties and their Subsidiaries have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Lawsfailure to do so could not reasonably be expected, including reporting to FDA and other agencieseither individually or in the aggregate, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAresult in a Material Adverse Effect; (ii) has notthat the Loan Parties and their Subsidiaries have not received any communication from any Governmental Authority regarding, and there are no facts or circumstances that are likely to give rise to (A) any material adverse change in any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit, that could reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect; (iii) that none of its the officers, directors, employees, shareholders, their agents or affiliates haveAffiliates of any Loan Party or any Subsidiary or, to any Loan Party’s knowledge after reasonable and diligent inquiry and investigation, any consultant involved in any Product application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (iv) that none of the officers, directors, employees, shareholders, agents or Affiliates of any Loan Party or any Subsidiary or, to any Loan Party’s knowledge after reasonable and diligent inquiry and investigation, any consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA, Health Canada or other Governmental Authority relating to any Loan Party or any Subsidiary, their business operations and Products, when submitted to the FDA, Health Canada or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA, Health Canada or other Governmental Authority. The Required Permits issued by the FDA, Health Canada and other Governmental Authorities for the Loan Parties’ and their Subsidiaries’ Products are valid and supported by proper research, design, testing, analysis and disclosure; (vi) that all preclinical and clinical trials in respect of the activities of the Loan Parties and their Subsidiaries being conducted by or on behalf of the Loan Parties and their Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide (including Health Canada), in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (vii) that neither any Loan Party nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, Health Canada has commenced or threatened to initiate any action against any Loan Party or a Subsidiary, any action to enjoin any Loan Party or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal actionaction that could reasonably be expected, either individually or which would result in the revocationaggregate, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable LawsMaterial Adverse Effect; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each that neither any Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2008, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishmentswith regard to any Product or the use, manufacture, processing, packaging or holding thereof, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the use, manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xiix) except as set forth on Schedule 6.26(athat neither any Loan Party nor any Subsidiary (A) has engaged in any recalls, field notifications, Market Withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance of the Products issued by any Loan Party or any Subsidiary, any clinical investigator, and/or other third party (“Safety Notices”), maintains (B) has knowledge of any material product complaints with respect to the Products or causes (C) has knowledge of any facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products or (3) a termination or suspension of developing and testing of any of the Products, in each case of clauses (A), (B) or (C) above, which could reasonably be maintained expected, either individually or in the aggregate, to have a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerMaterial Adverse Effect. (b) With respect to Products, the Loan Parties represent and warrant that: (i) No all Products are listed on Schedule 1.01 and the Loan Parties have delivered to the Administrative Agent on or prior to the Effective Date copies of all Required Permits relating to such Products issued or outstanding as of the Effective Date; provided, that, if after the Effective Date, any Loan Party has acquiredor any Subsidiary wishes to manufacture, receivedsell, clinically test or market any new Product, the Borrowers shall give prior written notice to the Administrative Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the Loan Party’s or such Subsidiary’s manufacture, sale, clinical testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an updated Schedule 1.01; and provided, further, that, if any Loan Party and/or any Subsidiary shall at any time obtain any new or additional Required Permits from the FDA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA (including Health Canada), or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to the Administrative Agent, the Borrowers shall give written notice to the Administrative Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof; (ii) Except each Product is not adulterated or misbranded within the meaning of the FDCA (or with respect to Products sold outside of the United States, within the meaning of those terms as set forth on Schedule 6.26(bdefined in applicable local Law), except where a failure of a Product so to comply could not reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect; (iii) each Product is not an article prohibited from use or introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA, except where such introduction of a prohibited Product could not reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect; (iv) each Product has been and/or and shall be used, manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but except where a failure to do so could not limited reasonably be expected, either individually or in the aggregate, to the FDCAhave a Material Adverse Effect; (iiiv) Without each Product has been and shall be manufactured in accordance with customary manufacturing practices, except where a failure to do so could not reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect; (vi) (A) without limiting the generality of Section 6.26(a)(i6.23(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any the Loan Party Parties and their Subsidiaries, except as could not reasonably be expected, either individually or any Subsidiary of any in the aggregate, to have a Material Adverse Effect, the Loan Party, such Person has Parties and their Subsidiaries have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, Loan Party or such Subsidiary and such Person (B) neither any Loan Party nor any Subsidiary has not received any notice from any applicable Governmental Authority, specifically including the FDAFDA and Health Canada, that such Governmental Authority is conducting an investigation or review of (Ax) such Person’s the Loan Parties and their Subsidiaries’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture of such Product, Product or (By) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or or manufacturing of such Product by such Person the Loan Parties and their Subsidiaries should cease; (ivvii) Without without limiting the generality of Section 6.26(a)(i6.23(a)(i) and (ii) above, (A) with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party or any Subsidiary of any Subsidiary, except as could not reasonably be expected, either individually or in the aggregate, to have a Material Adverse Effect, the Loan Party, such Person Parties and their Subsidiaries shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the provision, use, marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Person, the Loan Parties and such Person their Subsidiaries and (B) neither any Loan Party nor any Subsidiary has not received any notice from any applicable Governmental Authority, specifically including the FDAFDA and Health Canada, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and; (vviii) the neither any Loan Parties and their Subsidiaries have not Party nor any Subsidiary has experienced any significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them any Loan Party or any of its Subsidiaries in accordance with all specifications thereof and any required payments the Required Permits related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.; and (cix) Neither none of the execution nor performance by any Loan Party Products is currently, and have not for the past six (6) years been, the subject of any Loan Documentsclaim or allegation, nor formal or informal, that any Product, or its use, is defective or has resulted in or proximately caused any injury to any Person or property, except for such claims and allegations as could not, individually or in the exercise of any remedies by any party thereunderaggregate, will adversely affect any of the Required Permitsreasonably be expected to have a Material Adverse Effect.

Compliance of Products. (a) Each The Loan PartyParties represent and warrant: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in that the Borrower and its Subsidiaries possess all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified LawsPermits, including reporting to Regulatory Approvals from the FDA and other agenciesGovernmental Authorities required for the conduct of their business as currently conducted, except where the failure to include state government agencies of product deviationsso possess could not reasonably be expected to result in a Material Adverse Effect, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting all such Permits are in full force and effect, except where the failure to FDA of Corrections or Removals, when be in full force and as required under the FDCAeffect could not reasonably be expected to result in a Material Adverse Effect; (ii) has notthat the Borrower and its Subsidiaries have not received any written communication from any Governmental Authority regarding any failure to materially comply with any Laws, and including any terms or requirements of any Regulatory Approval and, to the knowledge of the Loan Parties, there are no facts or circumstances that are reasonably likely to give rise to any revocation, withdrawal, suspension, cancellation, material limitation, termination or adverse modification of any material Regulatory Approval; (iii) that none of its the officers, directors, employeesemployees or, shareholdersto the Loan Parties’ knowledge, their agents Affiliates of the Borrower or affiliates haveany Subsidiary or any agent or consultant involved in any Drug Application, has been alleged to have committed or convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (iv) that none of the officers, directors, employees or, to the Loan Parties’ knowledge, Affiliates of the Borrower or any Subsidiary or any agent or consultant has (A) made an untrue statement of material fact or fraudulent statement to the FDA any Regulatory Authority or failed to disclose a material fact required to be disclosed to the FDA, a Regulatory Authority; or (B) committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Regulatory Approval from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority; (vi) that all preclinical and clinical trials conducted by or on behalf of the Borrower and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any request for a Regulatory Approval, are being or have been conducted in compliance in all material respects with the required experimental protocols and applicable Laws; (vii) that all Products have since January 1, 2016 been manufactured, transported, stored and handled in all material respects in accordance with current good manufacturing practices applicable from time to time and applicable Laws; (viii) that neither the Borrower nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCPMaterial Adverse Effect; (ix) except as set forth on Schedule 6.26(a), neither the Borrower nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2016, a Warning Letter, unresolved Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, other ,” or similar written correspondence or notice setting forth allegedly objectionable observations or alleged alleging violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority other Governmental Authority with regard to any Product or the manufacture, processing, packing, packaging or holding thereof;thereof that could reasonably be expected to have a Material Adverse Effect; and (x) has entered into that, since January 1, 2016, (A) there have been no Safety Notices, (B) to the Loan Parties’ knowledge, there are no unresolved material product complaints with respect to the Products which could reasonably be expected to have a Transport Material Adverse Effect, and Disposal Agreement (C) to the Loan Parties’ knowledge, there are no facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a reputable and qualified Person for material change in the transport and disposal labeling of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and any of the Products, or (xi3) except as set forth on Schedule 6.26(a), maintains a termination or causes to be maintained a policy that prevents the exposure suspension of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannermarketing of Udenyca. (b) With respect to Products, the Loan Parties represent and warrant that: (i) No Loan Party has acquiredas of the Closing Date, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law.all material Products are listed on Schedule 1.01; (ii) Except as set forth on Schedule 6.26(b)since January 1, 2016, the operation of the business of the Borrower and its Subsidiaries with respect to each Product Product, including the manufacture, import, marketing, promotion, sale, labeling, and distribution of the Products, has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance compliance with all applicable Permits and Applicable applicable Laws, including but except where a failure to so comply could not limited reasonably be expected to the FDCAhave a Material Adverse Effect; (iii) Without without limiting the generality of Section 6.26(a)(i6.23(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any the Borrower and its Subsidiaries, as of the Closing Date, to the Loan Party or Parties’ knowledge, neither the Borrower nor any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any written notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s the Borrower and its Subsidiaries’ (or any third party contractors therefor) manufacturing facilities and processes for manufacturing such Product or the marketing and sales of such Product, in each case which have disclosed identified any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture manufacture, marketing and/or sales of such ProductProduct that could reasonably be expected to result in a Material Adverse Effect, or (B) any such Required Permit Regulatory Approval that could be reasonably expected to result in a revocation or that any withdrawal of such Required Permit has been revoked or withdrawnRegulatory Approval, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.Governmental

Compliance of Products. (a) Each Loan Party: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (ii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iii) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except as set forth on Schedule 6.26(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in all material respects in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Credit Party: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in obtained all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCARequired Permits; (ii) to its knowledge, has notnot used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a (a) or (b), where the use of such Person to perform such services could reasonably be expected to result in a Material Adverse Effect; (iii) warrants and represents that, to its knowledge, none of its officers, directors, employeesor employees has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a (a) or authorized by 00 X.X. Xxxxxxx 000x (b); (iv) warrants and represents that none of its officers, shareholdersdirectors or employees has, their agents or affiliates haveon behalf of the Company, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, or committed an act, made a statement, or failed to make a statement that that, in the case of each of the foregoing, could reasonably be expected to provide a basis for result in the FDA to invoke invoking its policy respecting “"Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” " set forth in 56 Fed. Regulation 46191 (September 10, 1991); (iiiv) has not received any written notice that from any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agencyJustice, that such Governmental Authority has commenced or threatened to initiate any action to enjoin a Loan Party, or the Borrower from conducting any material portion of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, busine ss or for any material civil penalty, injunction, seizure or criminal action, or which would result in action material to the revocation, transfer, surrender, suspension or other material impairment of any material portion business of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawBorrower; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a)3.24, has not received from the FDA or the DEA, at any time warning letterssince January 1, 2003, a Warning Letter, Form FDA-483 inspection reports, “or "Untitled Letter”, other correspondence or notice ," setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDAFDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant , which violations could reasonably be expected to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received result in a decontaminated mannerMaterial Adverse Effect. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law[RESERVED. (ii) Except as set forth on Schedule 6.26(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.]

Compliance of Products. (a) Each Loan Party: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (ii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iii) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits;; CHAR1\1982293v2 (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products:: CHAR1\1982293v2 (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except as set forth on Schedule 6.26(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan PartyBorrower and each Subsidiary: (i) except as set forth on Schedule 6.26(a)has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all Laws including the Specified Laws, and all such Required Permits are current and each holder of such Required Permits is in material compliance with the terms and conditions of all such Required Permits; (ii) has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (iiiii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991);; Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. (iiiiv) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Credit Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required PermitsPermit; (ivv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (vvi) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws laws or regulations, or (C) made a party to any other action by any Governmental Authority governmental authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawLaw; (vivii) is in material compliance with all Environmental Laws; (viiviii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable applicable regulations and Laws; (viiiix) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, Laws and customary business practices for each Loan Party Borrower which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (Cagents;(C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ixx) except as set forth on Schedule 6.26(a3.25(a)(x), has not received from the FDA at any time warning lettersWarning Letters, Form FDA-483 inspection reports, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (xxi) except as set forth on Schedule 3.25(a)(xi), has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products at any time; (xii) has entered into, or will enter into a Transport and Disposal Agreement as required, an agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable applicable regulations and Laws and such Transport and Disposal Agreement remains in full force and effect; and; (xixiii) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner; (b) Parent and BioHorizons each hereby represents and warrants, in addition to Section (a)(i) through (xiii) that it; (i) has implemented or is causing to be implemented all corrective actions agreed to in response to observations and/or deficiencies noted in any inspection or audit by any Governmental Authority or other licensing organization at each respective facility including but not limited to all corrective actions outlined in the response to the FDA Warning letter issued to BioHorizons Implant Systems, Inc. on December 27, 2004 and to address any deficiencies raised in the FDA 483 Inspectional Observations issued to BioHorizons on August 18, 2006; (ii) conducts sufficient and regular internal quality audits, evaluations of suppliers/contractors, and conducts management review Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. meetings at regularly defined intervals in compliance with Specified Laws; (iii) has implemented a procedure to conduct follow-up investigations to maintain full documentation of each batch of finished devices to meet applicable acceptable criteria before release for distribution in accordance with Specified Laws; (iv) has implemented a procedure to conduct follow-up investigations to complaints involving the failure of devices to meet specifications and documents the reasons for the lack of investigations if none are undertaken, and that such procedure provides for the complete review and evaluation of complains and that all complaints received are processed in a uniform and timely matter and in compliance with Specified Laws; (v) has implemented a procedure to conduct and document adequate corrective and preventive actions in response to complaints involving the failure of medical devices to meet specifications in compliance with the requirements of Specified Laws; (vi) has implemented a procedure for validation and verification of design changes prior to implementation of such changes in compliance with Specified Laws; (vii) has ensured that the medical device reporting procedure within the company’s internal systems provides for timely transmission of complete medical device reports to FDA in compliance with Specified Laws; and (viii) has taken all such actions necessary to ensure the hiring of adequate staff to perform regulatory functions and that all individuals holding responsibility for regulatory functions, in a management or supervisory capacity, possess the requisite experience, training and certifications to carry out their job responsibilities. (bc) With respect to Products: (i) No Loan Party Borrower or any Subsidiary of any Borrower has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except Schedule 3.25(c)(ii) hereto lists all Required Permits issued by a Governmental Authority in North America relating to a Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof maintained by Borrowers as set forth of the Closing Date, together with the applicable Product category corresponding to the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. Required Permits. Borrowers have delivered to Administrative Agent on or prior to the Closing Date copies of all such Required Permits. If, after the Closing Date, any Borrower acquires or renews any Required Permit issued by a Governmental Authority in North America relating to a Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof issued, such Borrower shall promptly deliver a copy of such new or renewed Required Permit along with a copy of an amended and restated Schedule 6.26(b3.25(c)(ii), ; (iii) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiiiv) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party Borrower or any Subsidiary of any Loan PartyBorrower, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Government Authority, including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Lawshealthcare laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (ivv) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party Borrower or any Subsidiary of any Loan PartyBorrower, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vvi) the Loan Parties Borrowers and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the Portions of this Exhibit were omitted and have been filed separately with the Secretary of the Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 406 of the Securities Act of 1933, as amended. amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (cd) Parent and BioHorizons each hereby represent and warrant, in addition to Section (c)(i) through (vi) that, with respect to Products: (i) Each Product commercially distributed within the past 12 months is not adulterated or misbranded within the meaning of the FDCA; (ii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 510(k) or 515 of the FDCA; (iii) Each Product has been and/or shall be designed and manufactured in accordance with Good Manufacturing Practice as defined in the Quality System Regulation 21 C.F.R. Part 820; (e) Neither the execution nor performance by any Loan Party Borrower or any of its Subsidiaries of any Loan Financing Documents or other Operative Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each The Loan PartyParties represent and warrant: (i) except as set forth on Schedule 6.26(a)that the Parent and its Subsidiaries have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Laws, including reporting failure to FDA and other agencies, do so could not reasonably be expected to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAresult in a Material Adverse Effect; (ii) has notthat the Parent and its Subsidiaries have not received any communication from any Governmental Authority regarding, and there are no facts or circumstances that are likely to give rise to (A) any material adverse change in any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit; (iii) that none of its the officers, directors, employees, shareholders, their agents agents, Affiliates of the Parent or affiliates haveany Subsidiary or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant involved in any Product application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (iv) that none of the officers, directors, employees, shareholders, agents, Affiliates of the Parent or any Subsidiary or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Parent or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. The Required Permits issued by the FDA and other Governmental Authorities for the Parent’s and its Subsidiaries’ products are valid and supported by proper research, design, testing, analysis and disclosure; (vi) that all preclinical and clinical trials in respect of the activities of the Parent and its Subsidiaries being conducted by or on behalf of the Parent and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (vii) that neither the Parent nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Parent or a Subsidiary, any action to enjoin the Parent or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable LawsMaterial Adverse Effect; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Lawsthat, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a)6.25, neither the Parent nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2008, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishmentswith regard to any Product or the manufacture, processing, packaging or holding thereof, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xiix) that, except as set forth on Schedule 6.26(a6.25, neither the Parent nor any Subsidiary (A) has engaged in any Recalls, field notifications, Market Withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance of the Products issued by the Parent or any Subsidiary, any clinical investigator, and/or other third party (“Safety Notices”), maintains (B) has knowledge of any material product complaints with respect to the Products which, if true, could reasonably be expected to have a Material Adverse Effect, and (C) has knowledge of any facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products, or causes to be maintained (3) a policy that prevents termination or suspension of developing and testing of any of the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerProducts. (b) With respect to Products, the Loan Parties represent and warrant that: (i) No Loan Party all Products are listed on Schedule 1.01 and the Borrower has acquireddelivered to the Administrative Agent on or prior to the Closing Date copies of all Required Permits relating to such Products issued or outstanding as of the Closing Date; provided, receivedthat, if after the Closing Date, the Parent or any Subsidiary wishes to manufacture, sell, develop, test or market any new Product, the Borrower shall give prior written notice to the Administrative Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the Parent’s or such Subsidiary’s manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an updated Schedule 1.01; and provided, further, that, if the Parent and/or any Subsidiary shall at any time obtain any new or additional Required Permits from the FDA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Administrative Agent, the Borrower shall promptly give written notice to Administrative Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except as set forth on Schedule 6.26(b)each Product is not adulterated or misbranded within the meaning of the FDCA, except where a failure of a Product so to comply could not reasonably be expected to have a Material Adverse Effect; (iii) each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA, except where such introduction of a prohibited Product could not reasonably be expected to have a Material Adverse Effect; (iv) each Product has been and/or and shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but except where a failure to do so could not limited reasonably be expected to the FDCAhave a Material Adverse Effect; (iiiv) Without each Product has been and shall be manufactured in accordance with customary manufacturing practices, except where a failure to do so could not reasonably be expected to have a Material Adverse Effect; (vi) without limiting the generality of Section 6.26(a)(i6.25(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Partythe Parent and its Subsidiaries, such Person has the Parent and its Subsidiaries have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of the Parent or such PersonSubsidiary, and such Person and, to the Borrower’s knowledge, neither the Parent nor any Subsidiary has not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s the Parent and its Subsidiaries’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or or manufacturing of such Product by such Person the Parent and its Subsidiaries should cease; (ivvii) Without without limiting the generality of Section 6.26(a)(i6.25(a)(i) and (ii) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party the Parent or any Subsidiary of any Loan Partyits Subsidiaries, such Person the Parent and its Subsidiaries shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Personthe Parent and its Subsidiaries, and such Person and, to the Borrower’s knowledge, neither the Parent nor any Subsidiary has not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vviii) neither the Loan Parties and their Subsidiaries have not Parent nor any Subsidiary has experienced any significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them the Parent or any of its Subsidiaries in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan PartyThe Credit Parties: (i) except as set forth on Schedule 6.26(a)have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Laws, including reporting failure to FDA and other agencies, do so could not reasonably be expected to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAresult in a Material Adverse Effect; (ii) has nothave not received any communication from any Governmental Authority regarding, and there are no facts or circumstances that are likely to give rise to (A) any material adverse change in any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit; (iii) have not used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a; (iv) warrant and represent that none of its their officers, directors, employees, shareholders, agents, Affiliates or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant involved in any Product application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (v) warrant and represent that none of their agents or affiliates haveofficers, directors, employees, shareholders, agents, Affiliates or, to Borrower’s knowledge after reasonable and diligent inquiry and investigation, any consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiivi) has warrant and represent that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Credit Parties, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. The Required Permits issued by the FDA and other Governmental Authorities for the Credit Parties’ products are valid and supported by proper research, design, testing, analysis and disclosure; (vii) warrant and represent that all preclinical and clinical trials in respect of the activities of the Credit Parties being conducted by or on behalf of the Credit Parties that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (viii) have not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Loan Credit Party, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCPMaterial Adverse Effect; (ix) except as set forth on Schedule 6.26(a)3.24, has the Credit Parties have not received from the FDA or the DEA, at any time warning letterssince January 1, 2008, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDAFDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xix) except as set forth on Schedule 6.26(a3.24, (A) the Credit Parties have not engaged in any Recalls, field notifications, Market Withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance of the Products issued by the Credit Parties, any clinical investigator, and/or other third party (“Safety Notices”), maintains (B) have no knowledge of any material product complaints with respect to the Products which, if true, could reasonably be expected to have a Material Adverse Effect, and (C) have no knowledge of any facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products, or causes to be maintained (3) a policy that prevents termination or suspension of developing and testing of any of the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerProducts. (b) With respect to Products: (i) No Loan Party All Products are listed on Schedule 1.1 and Borrower has acquireddelivered to Administrative Agent on or prior to the Closing Date copies of all Required Permits relating to such Products issued or outstanding as of the Closing Date; provided, receivedhowever, that, if after the Closing Date, the Credit Parties wish to manufacture, sell, develop, test or market any new Product, Borrower shall give prior written notice to Administrative Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the Credit Parties’ manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an amended and restated Schedule 1.1; and further, provided, that, if the Credit Parties shall at any time obtain any new or additional Required Permits from the FDA, DEA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, DEA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Administrative Agent, Borrower shall promptly give written notice to Administrative Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except Each Product is not adulterated or misbranded within the meaning of the FDCA, except where a failure of a Product so to comply could not reasonably be expected to have a Material Adverse Effect; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA, except where such introduction of a prohibited Product could not reasonably be expected to have a Material Adverse Effect; (iv) Each Product that is sold pursuant to the Credit Parties’ belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses, except where a failure of a Product to meet such conditions could not reasonably be expected to have a Material Adverse Effect; (v) Each Product for which a Drug Efficacy Study Implementation (“DESI”) notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth on Schedule 6.26(b)in such DESI notice, each except where a failure to conform could not reasonably be expected to have a Material Adverse Effect; (vi) Each Product has been and/or and shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but except where a failure to do so could not limited reasonably be expected to the FDCAhave a Material Adverse Effect; (iiivii) Each Product has been and shall be manufactured in accordance with Good Manufacturing Practices, except where a failure to do so could not reasonably be expected to have a Material Adverse Effect; (viii) Without limiting the generality of Section 6.26(a)(i3.24(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Partythe Credit Parties, such Person has the Credit Parties have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Personthe Credit Parties, and such Person has and, to the Credit Parties’ knowledge, the Credit Parties have not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s the Credit Parties’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or or manufacturing of such Product by such Person the Credit Parties should cease; (ivix) Without limiting the generality of Section 6.26(a)(i3.24(a)(i) and (ii) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party or any Subsidiary of any Loan Partythe Credit Parties, such Person the Credit Parties shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Personthe Credit Parties, and such Person has and, to the Credit Parties’ knowledge, the Credit Parties have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vx) the Loan The Credit Parties and their Subsidiaries have not (since the Closing Date) experienced any significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them the Credit Parties in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Party: (i) except as set forth on Schedule 6.26(a), has been operating in compliance in The Borrower and its Subsidiaries possess all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified LawsPermits, including reporting to Regulatory Approvals from the FDA and other agenciesGovernmental Authorities required for the conduct of their business as currently conducted, except where the failure to include state government agencies of product deviationsso possess could not reasonably be expected to result in a Material Adverse Effect, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting all such Permits are in full force and effect, except where the failure to FDA of Corrections or Removals, when be in full force and as required under the FDCAeffect could not reasonably be expected to result in a Material Adverse Effect; (ii) has notThe Borrower and its Subsidiaries have not received any written communication from any Governmental Authority regarding any failure to materially comply with any Laws, and none including any terms or requirements of its any Regulatory Approval and, to the knowledge of the Loan Parties, there are no facts or circumstances that are reasonably likely to give rise to any revocation, withdrawal, suspension, cancellation, material limitation, termination or adverse modification of any material Regulatory Approval; (iii) None of the officers, directors, employeesemployees or, shareholdersto the Loan Parties’ knowledge, Affiliates of the Borrower or any Subsidiary or any agent or consultant involved in any Drug Application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a nor, to the Loan Parties knowledge, are any debarment proceedings or investigations pending or threatened against the Borrower or any Subsidiary or any of their agents respective officers, employees or affiliates haveagents; (iv) None of the officers or directors, or, to the Loan Parties’ knowledge, employees or Affiliates of the Borrower or any Subsidiary or any agent or consultant has (A) made an untrue statement of material fact or fraudulent statement to the FDA any Regulatory Authority or failed to disclose a material fact required to be disclosed to the FDA, a Regulatory Authority; or (B) committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) All applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Regulatory Approval from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority; (vi) All preclinical and clinical trials conducted by or on behalf of the Borrower and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any request for a Regulatory Approval, are being or have been conducted in compliance in all material respects with the required experimental protocols and applicable Laws; (vii) All Products have since January 1, 2016 been manufactured, transported, stored and handled in all material respects in accordance with current good manufacturing practices applicable from time to time and applicable Laws; (viii) Neither the Borrower nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCPMaterial Adverse Effect; (ix) except as set forth on Schedule 6.26(a), Neither the Borrower nor any Subsidiary has not received from the FDA FDA, at any time warning letterssince January 1, 2016, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xi) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Except as set forth on Schedule 6.26(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iii) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (iv) Without limiting the generality of Section 6.26(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (v) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.,” or

Compliance of Products. (a) Each Loan PartyBorrower and each Subsidiary: (i) except as set forth on Schedule 6.26(a)has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all Laws including the Specified Laws, and all such Required Permits are current and each holder of such Required Permits is in material compliance with the terms and conditions of all such Required Permits; (ii) has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (iiiii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiiv) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Credit Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required PermitsPermit; (ivv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (vvi) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws laws or regulations, or (C) made a party to any other action by any Governmental Authority governmental authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawLaw; (vivii) is in material compliance with all Environmental Laws; (viiviii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products products, human tissue and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable applicable regulations and Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth on Schedule 6.26(a3.25(a)(ix), has not received from the FDA at any time warning lettersWarning Letters, Form FDA-483 inspection reports, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) except as set forth on Schedule 3.25(a)(x), has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products at any time; (xi) has entered into a Transport and Disposal Agreement an agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable applicable regulations and Laws and such Transport and Disposal Agreement remains in full force and effect; and; (xixii) except as set forth on Schedule 6.26(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner; (xiii) has implemented or is causing to be implemented all corrective actions agreed to in response to observations and/or deficiencies noted in any inspection or audit by any Governmental Authority or other licensing organization at each respective facility, including but not limited to the corrective actions outlined in Borrowers’ response to the FDA dated November 26, 2003 to address deficiencies raised in the FDA Form 483 issued to Borrowers on November 18, 2003; (xiv) conducts sufficient and regular internal quality audits, evaluations of suppliers/contractors, and conducts management review meetings at regularly defined intervals in compliance with Specified Laws; (xv) has initiated the implementation of a procedure for validation of software according to established procedures governing process and software validation; (xvi) has ensured that process controls including those dealing with “passivation” are conducted in accordance with documented instructions and standard operating procedures; (xvii) has implemented a procedure to ensure that periodic inspections of equipment and documentation of those inspections are conducted in accordance with established procedures to ensure adherence to applicable maintenance schedules; (xviii) has implemented a procedure for the visual inspection of microscopes and other equipment to ensure that schedules for the adjustment, cleaning and other maintenance of equipment are established and implemented; (xix) has implemented a procedure to perform integrity testing on sterile product sampled from finished goods inventory to include acceptance criteria to be established and documented as well as requirements for remedial action in event of failure; (xx) has taken all actions necessary to ensure that the procedures inkling work instructions necessary for implementing corrective and preventive actions are complete and implemented; (xxi) has taken all actions to ensure that the procedure to ensure that equipment is routinely calibrated is complete and that appropriate training is conducted to ensure that these actions are carried out; and (xxii) has ensured that adequate staff to perform regulatory functions is in place and that all individuals holding responsibility for regulatory functions, in a management or supervisory capacity, possess the requisite experience, training and certifications to carry out their job responsibilities. (b) With respect to Products: (i) No Loan Party Borrower or any Subsidiary of any Borrower has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law.; (ii) Except Schedule 3.25 (b)(ii) hereto lists all Required Permits issued by a Governmental Authority in North America relating to a Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof maintained by Borrowers as set forth of the Closing Date, together with the applicable Product category corresponding to the Required Permits. Borrowers have delivered to Administrative Agent on or prior to the Closing Date copies of all such Required Permits. If, after the Closing Date, any Borrower acquires or renews any Required Permit issued by a Governmental Authority in North America relating to a Product and/or the applicable Borrower’s manufacture, sale, development, testing or marketing thereof issued, such Borrower shall promptly deliver a copy of such new or renewed Required Permit along with a copy of an amended and restated Schedule 6.26(b3.25 (b)(ii), each ; (iii) Each Product commercially distributed within the past 12 months is not adulterated or misbranded within the meaning of the FDCA; (iv) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 510(k) or 515 of the FDCA; (v) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiivi) Each Product has been and/or shall be designed and manufactured in accordance with Good Manufacturing Practice as defined in the Quality System Regulation 21 C.F.R. Part 820 and Current Good Tissue Practice, 21 CFR Part 1271 (Subpart D); (vii) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party Borrower or any Subsidiary of any Loan PartyBorrower, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Government Authority, including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law Laws (including Healthcare Lawshealthcare laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (ivviii) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party Borrower or any Subsidiary of any Loan PartyBorrower, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vix) the Loan Parties Borrowers and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party Borrower or any of its Subsidiaries of any Loan Financing Documents or other Operative Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan PartyThe Borrowers: (i) except as set forth on Schedule 6.26(a)have obtained all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for compliance in all material respects with all reporting Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Laws, including reporting failure to FDA and other agencies, do so could not reasonably be expected to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAresult in a Material Adverse Effect; (ii) has nothave not received any communication from any Governmental Authority regarding, and there are no facts or circumstances that are likely to give rise to (A) any material adverse change in any Required Permit, or any failure to materially comply with any Laws or any term or requirement of any Required Permit or (B) any revocation, withdrawal, suspension, cancellation, material limitation, termination or material modification of any Required Permit, except such facts and circumstances that could not individually or in the aggregate reasonably be expected to result in a Material Adverse Effect; (iii) have not used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a; (iv) warrant and represent that none of its their officers, directors, employees, shareholders, agents, Affiliates or, to Borrower's knowledge after reasonable and diligent inquiry and investigation, any consultant involved in any Product application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a; (v) warrant and represent that none of their agents or affiliates haveofficers, directors, employees, shareholders, agents, Affiliates or, to Borrower's knowledge after reasonable and diligent inquiry and investigation, any consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiivi) has warrant and represent that all applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Credit Parties, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. The Required Permits issued by the FDA and other Governmental Authorities for the Credit Parties’ products are valid and supported by proper research, design, testing, analysis and disclosure; (vii) warrant and represent that all preclinical and clinical trials in respect of the activities of the Credit Parties being conducted by or on behalf of the Credit Parties that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (viii) have not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Loan Credit Party, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not action that could reasonably be expected to have a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCPMaterial Adverse Effect; (ix) except as set forth on Schedule 6.26(a)3.25 as of the Restatement Closing Date or except as hereinafter disclosed to Agent in writing, has with reasonable detail, have not received from the FDA or the DEA, at any time warning letterssince January 1, 2008, a Warning Letter, Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including FDA or the FDCADEA, or any comparable correspondence from any state or local authority responsible for regulating medical device drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDAFDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (x) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable Laws and such Transport and Disposal Agreement remains in full force and effect; and (xix) except as set forth on Schedule 6.26(a3.25 as of the Restatement Closing Date or except as hereinafter disclosed to Agent in writing, with reasonable detail, (A) have not engaged in any Recalls, field notifications, Market Withdrawals, warnings, "dear doctor" letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance of the Products issued by the Credit Parties, any clinical investigator, and/or other third party (“Safety Notices”), maintains (B) have no knowledge of any material product complaints with respect to the Products which, if true, could reasonably be expected to have a Material Adverse Effect, and (C) have no knowledge of any facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products, or causes to be maintained (3) a policy that prevents termination or suspension of developing and testing of any of the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerProducts. (b) With respect to Products: (i) No Loan Party All Products are listed on Schedule 1.1 and Borrower has acquireddelivered to Agent on or prior to the Restatement Closing Date copies of all Required Permits relating to such Products issued or outstanding as of the Restatement Closing Date; provided, receivedhowever, that, if after the Restatement Closing Date, the Credit Parties wish to manufacture, sell, develop, test or market any new Product, Borrower shall give prior written notice to Agent of such intention (which shall include a brief description of such Product, plus copies of all Required Permits relating to such new Product and/or the Credit Parties’ manufacture, sale, development, testing or marketing thereof issued or outstanding as of the date of such notice) along with a copy of an amended and restated Schedule 1.1; and further, provided, that, if the Credit Parties shall at any time obtain any new or additional Required Permits from the FDA, DEA, or otherwise transferred parallel state or local authorities, or foreign counterparts of the FDA, DEA, or parallel state or local authorities, with respect to any human tissue Product which has previously been disclosed to Agent, Borrower shall promptly give written notice to Agent of such new or organs for valuable consideration for use in human transplantationadditional Required Permits, in violation of any Applicable Law.along with a copy thereof); (ii) Except Each Product is not adulterated or misbranded within the meaning of the FDCA, except where a failure of a Product so to comply could not reasonably be expected to have a Material Adverse Effect; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA, except where such introduction of a prohibited Product could not reasonably be expected to have a Material Adverse Effect; (iv) Each Product that is sold pursuant to the Credit Parties' belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses, except where a failure of a Product to meet such conditions could not reasonably be expected to have a Material Adverse Effect; (v) Each Product for which a Drug Efficacy Study Implementation (“DESI”) notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth on Schedule 6.26(b)in such DESI notice, each except where a failure to conform could not reasonably be expected to have a Material Adverse Effect; (vi) Each Product has been and/or and shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but except where a failure to do so could not limited reasonably be expected to the FDCAhave a Material Adverse Effect; (iiivii) Each Product has been and shall be manufactured in accordance with Good Manufacturing Practices, except where a failure to do so could not reasonably be expected to have a Material Adverse Effect; (viii) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Partythe Credit Parties, such Person has except as disclosed to Agent in writing, with reasonable detail, the Credit Parties have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Personthe Credit Parties, and such Person has and, to the Credit Parties' knowledge, the Credit Parties have not received any notice from any applicable Governmental Government Authority, specifically including the FDA, that such Governmental Government Authority is conducting an investigation or review of (A) such Person’s the Credit Parties' manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or or manufacturing of such Product by such Person the Credit Parties should cease; (ivix) Without limiting the generality of Section 6.26(a)(i3.25(a)(i) and (ii) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party or any Subsidiary of any Loan Partythe Credit Parties, such Person except as disclosed to Agent in writing, with reasonable detail, the Credit Parties shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Personthe Credit Parties, and such Person has and, to the Credit Parties' knowledge, the Credit Parties have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vx) the Loan The Credit Parties and their Subsidiaries have not (since the Restatement Closing Date) experienced any significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them the Credit Parties in accordance with all specifications thereof and any required payments the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month, except as which could not reasonably be expected to result in a Material Adverse Effect. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan Party: (i) has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all applicable Laws including the Specified Laws, and all such Required Permits are current and each holder of such Required Permits is in material compliance with the terms and conditions of all such Required Permits; (ii) except as set forth on Schedule 6.26(a5.30(a), has been operating in compliance in all material respects with all reporting and regulatory requirements imposed upon it as well as the Specified Laws, including reporting to FDA and other agencies, to include state government agencies of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCA; (iiiii) has not, and none of its officers, directors, employees, shareholders, their agents or affiliates have, made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiiv) has not received any notice that any Governmental Authority, including the FDA, the Office of the Inspector General of HHS, the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action to enjoin a Loan Party, or any of its officers, directors, employees, shareholders, agents or Affiliates, from conducting their respective businesses at any facility owned or used by any of them, or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required PermitsPermit; (ivv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (vvi) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any lawLaw; (vivii) is in material compliance with all Environmental Laws; (viiviii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable applicable regulations and Laws; (viiiix) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (Cagents;(C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ixx) except as set forth on Schedule 6.26(a5.30(a), has not received from the FDA at any time warning letters, Form FDA-483 inspection reports, “Untitled Letter”, other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable correspondence from any state or local authority responsible for regulating medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; (xxi) [reserved]; (xii) has entered into a Transport and Disposal Agreement with a reputable and qualified Person for the transport and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport and disposal services at all facilities at which such biomedical wastes and hazardous wastes are generated in conformity in all material respects with all Applicable applicable regulations and Laws and such Transport and Disposal Agreement remains in full force and effect; and (xixiii) except as set forth on Schedule 6.26(a5.30(a), maintains or causes to be maintained a policy that prevents the exposure of employees or contractors to bloodborne pathogens by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated manner. (b) With respect to Products: (i) No Loan Party has acquired, received, or otherwise transferred any human tissue or organs for valuable consideration for use in human transplantation, in violation of any Applicable Law. (ii) Schedule 5.30(b), hereto lists all Required Permits issued by a Governmental Authority relating to a Product and/or the applicable Loan Party’s manufacture, sale, development, testing or marketing thereof maintained by Loan Parties as of the Closing Date, together with the applicable Product category corresponding to the Required Permits. Loan Parties have delivered to the Administrative Agent on or prior to the Closing Date copies of all such Required Permits. If, after the Closing Date, any Loan Party acquires or renews any Required Permit issued by a Governmental Authority relating to a Product and/or the applicable Loan Party’s manufacture, sale, development, testing or marketing thereof issued, Loan Parties shall promptly deliver a copy of such new or renewed Required Permit along with a copy of an update to Schedule 5.30(b); (iii) Except as set forth on Schedule 6.26(b5.30(b), each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Permits and Applicable Laws, including but not limited to the FDCA; (iiiiv) Without limiting the generality of Section 6.26(a)(i5.30(a)(i) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Party, such Person has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law applicable Laws (including Healthcare Laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by such Person should cease; (ivv) Without limiting the generality of Section 6.26(a)(i5.30(a)(i) above, with respect to any Product marketed, leased, rented, or sold by any Loan Party or any Subsidiary of any Loan Party, such Person shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed, leased, rented, or sold by such Person, and such Person has not received any notice from any applicable Governmental Authority, including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (vvi) the Loan Parties and their Subsidiaries have not experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by them in accordance with all specifications thereof and any required payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month. (c) Neither the execution nor performance by any Loan Party of any Loan Documents, nor the exercise of any remedies by any party thereunder, will adversely affect any of the Required Permits.

Compliance of Products. (a) Each Loan PartyWith respect to the Borrower and its Subsidiaries: (i) except as set forth on Schedule 6.26(a)the Borrower and its Subsidiaries hold all Required Permits, has been operating in or have contracted with third parties holding Required Permits, necessary for the Borrower and its Subsidiaries’ compliance in all material respects with all reporting applicable Laws and regulatory requirements imposed upon it as well as all such Required Permits are in full force and effect, except where the Specified Laws, including reporting failure to FDA be in full force and other agencies, effect could not reasonably be expected to include state government agencies result in a Material Adverse Effect or have a material adverse effect on the commercialization of product deviations, contamination or of device malfunctions and/or device-related serious injuries or deaths and reporting to FDA of Corrections or Removals, when and as required under the FDCAany Product; (ii) has the Borrower and its Subsidiaries have not, and within the past three (3) years, received any written communication from any Governmental Authority regarding any failure to materially comply with any Laws or any term or requirement of any Regulatory Permit and, to the knowledge of the Loan Parties, there are no facts or circumstances that are reasonably likely to give rise to any revocation, withdrawal, suspension, cancellation, material limitation, termination or material adverse modification of any Regulatory Permit; (iii) none of its the officers, directors, employees, shareholdersor Affiliates of the Borrower or any Subsidiary or, their agents to the Borrower’s knowledge, any shareholder, agent or affiliates haveconsultant involved with any Product or with any Device Application, has been convicted of any crime or engaged in any conduct for which debarment is authorized by 21 U.S.C. Section 335a or other applicable Law; (iv) none of the officers, directors, employees, or Affiliates of the Borrower or any Subsidiary or, to the Borrower’s knowledge, any shareholder, agent or consultant has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could 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. Regulation 46191 (September 10, 1991); (iiiv) except as could not reasonably be expected to result in a Material Adverse Effect or have a material adverse effect on the commercialization of any Product, all filings, applications, notifications, submissions, information, claims, reports and statistics and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Required Permit from the FDA or other Governmental Authority relating to the Borrower or any Subsidiary, their business operations and Products, when submitted to the FDA or other Governmental Authority were true, complete and correct in all material respects as of the date of submission or any necessary or required updates, changes, corrections or modifications to such filings, applications, submissions, information and data have been submitted to the FDA or other Governmental Authority. To the Borrower’s knowledge, the Required Permits issued by the FDA and other Governmental Authorities for the Borrower’s and its Subsidiaries’ Products are valid; (vi) except as could not reasonably be expected to result in a Material Adverse Effect or have a material adverse effect on the commercialization of any Product, all preclinical and clinical trials conducted by or on behalf of the Borrower and its Subsidiaries that have been submitted to any Governmental Authority, including the FDA and its counterparts worldwide, in connection with any Required Permit, are being or have been conducted in compliance in all material respects with the required experimental protocols, procedures and controls pursuant to applicable Laws; (vii) neither the Borrower nor any Subsidiary has not received any written notice that any Governmental Authority, including without limitation the FDA, the Office of the Inspector General of HHS, HHS or the United States Department of Justice or any equivalent foreign agency, has commenced or threatened to initiate any action against the Borrower or a Subsidiary, any action to enjoin the Borrower or a Loan PartySubsidiary, or any of its officers, directors, employees, shareholders, shareholders or its agents or and Affiliates, from conducting their respective businesses its business at any facility owned or used by any of them, it or for any material civil penalty, injunction, seizure or criminal action, or which would result in the revocation, transfer, surrender, suspension or other material impairment of any material portion of the Required Permits; (iv) is not a participant in any federal program whereby any federal, state or local government or quasi-governmental body, agency, board or other authority may have the right to recover funds by reason of the advance of federal funds, including those authorized under the Xxxx-Xxxxxx Act (42 U.S.C. 291, et seq.); (v) has not been threatened to be (A) excluded from United States health care programs pursuant to 42 U.S.C. §1320a7 and related regulations, (B) “suspended” or “debarred” from selling products to the United States government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), or other applicable Laws or regulations, or (C) made a party to any other action by any Governmental Authority that may prohibit it from selling products to any governmental or other purchaser pursuant to any law; (vi) is in material compliance with all Environmental Laws; (vii) maintains or causes to be maintained a standard of care in the storage, use, transportation and disposal of all Products, medical equipment, medical supplies, medical products and medical waste, of any kind and in any form, that is at least comparable to that which exists on the date of this Agreement and that is in conformity in all material respects with all Applicable Laws; (viii) maintains or causes to be maintained corporate regulatory compliance program (“CCP”) in accordance with Specified Laws, applicable regulatory guidance, and customary business practices for each Loan Party which includes at least the following components: (A) specific officer within high-level personnel identified as having overall responsibility for regulatory compliance (B) training and education programs which effectively communicate the compliance standards and procedures to employees and agents; (C) policies and procedures to allow employees and other agents to anonymously report criminal or suspect conduct and potential compliance problems; (D) consistent enforcement of compliance policies including discipline of individuals responsible for the failure to detect violations of the CCP; and (E) mechanisms to immediately respond to detected violations of the CCP; (ix) except as set forth could not reasonably be expected to result in a Material Adverse Effect or have a material adverse effect on Schedule 6.26(a)the commercialization of any Product, neither the Borrower nor any Subsidiary has not received from the FDA at any time warning lettersa Warning Letter, unresolved Form FDA-483 inspection reportsFDA-483, “Untitled Letter”, ,” other written correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA, including the FDCA, or any comparable written correspondence from any foreign state or local authority responsible for regulating medical device products and establishmentsGovernmental Authority with regard to any Product or the use, manufacture, processing, packaging or holding thereof, or any comparable correspondence from any foreign counterpart of the FDA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the use, manufacture, processing, packing, or holding thereof; (ix) neither the Borrower nor any Subsidiary is enrolled in or currently receives payments from any federal or state government or private healthcare reimbursement program or has ever been terminated from any federal or state government or private healthcare reimbursement program (including Medicare or Medicaid) or otherwise had its rights to receive payments from any government or private healthcare reimbursement program adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other third party; (x) neither the Borrower nor any Subsidiary nor, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Borrower or any Subsidiary, has entered into been convicted of, charged with or, to the Borrower’s knowledge, investigated for any federal or state health program-related offense or any other offense related to healthcare or been terminated, excluded or suspended from participation in any such program; or, to the Borrower’s knowledge, has been convicted of, charged with or investigated for a Transport violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any regulatory authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substance; (xi) the Borrower and Disposal Agreement its Subsidiaries are in compliance with a reputable Section 6002 of the Affordable Care Act and qualified Person for similar state Laws regarding the transport reporting of certain payments to physicians and disposal of hazardous wastes pursuant to which such Person has agreed to provide such transport hospitals; (A) the Borrower and disposal services at all facilities at which such biomedical wastes and hazardous wastes its Subsidiaries are generated in conformity compliance in all material respects with all Applicable Laws the privacy and such Transport security requirements of the Health Insurance Portability and Disposal Agreement remains Accountability Act (“HIPAA”), (B) neither the Borrower nor any Subsidiary has received any written communication from any Governmental Authority that alleges non-compliance with HIPAA and (C) no breach or violation has occurred, to the knowledge of the Borrower, with respect to any unsecured protected health information maintained by or for the Borrower that is subject to the notification requirements of 45 C.F.R. §§ 164.406 or 164.408(b) or similar state Laws, and no information security or privacy breach event has occurred that would require notification under any applicable Laws; (xiii) neither the Borrower nor any Subsidiary (A) has engaged in full force any material recalls, field notifications, Market Withdrawals, warnings, “dear doctor” letters, investigator notices, safety alerts, “serious adverse event” reports or other notice of action relating to an alleged lack of safety or regulatory compliance of the Products issued by the Borrower or any Subsidiary (“Safety Notices”), (B) has knowledge of any material product complaints with respect to the Products and effect(C) has knowledge of any facts that would be reasonably likely to result in (1) a material Safety Notice with respect to the Products, (2) a material change in the labeling of any of the Products or (3) a termination or suspension of developing and testing of any of the Products; and (xixiv) except as set forth on Schedule 6.26(aneither the Borrower nor any Subsidiary, nor any officer, employee or, to the Borrower’s knowledge, agent of, any Loan Party or any Subsidiary, has been or has been threatened to be, (A) excluded or terminated from participation in any healthcare program of any Governmental Authority, (B) “suspended” or “debarred” from selling products to the U.S. government or its agencies pursuant to the Federal Acquisition Regulation, relating to debarment and suspension applicable to federal government agencies generally (48 C.F.R. Subpart 9.4), maintains or causes other applicable laws or regulations, (C) made a party to be maintained a policy any action by any Governmental Authority that prevents the exposure may prohibit it from selling products to any governmental or other purchaser pursuant to any federal, state or local laws or regulations or (D) has been convicted of employees any crime or contractors to bloodborne pathogens engaged in any conduct for which such exclusion, debarment or suspension is mandated by prohibiting staff from handling returned or used Product if such Product is not received in a decontaminated mannerapplicable Law. (b) With respect to Products: (i) No Loan Party all Products are listed on Schedule 1.01 and the Borrower has acquired, received, delivered to the Administrative Agent on or otherwise transferred any human tissue prior to the Effective Date copies of all Required Permits relating to such Products issued or organs for valuable consideration for use in human transplantation, in violation outstanding as of any Applicable Law.the Effective Date; (ii) Except each Product is not adulterated or misbranded within the meaning of the FDCA; (iii) each Product is not an article prohibited from use or introduction into interstate commerce under the provisions of the FDCA; (iv) except as set forth could not, individually or in the aggregate, reasonably be expected to result in a Material Adverse Effect or as could not reasonably be expected to have a material adverse effect on Schedule 6.26(b)the commercialization of any Product, each Product has been and/or and shall be used, manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance with all applicable Required Permits and Applicable applicable Laws, including but not limited to the FDCA; (iiiv) Without each Product has been and shall be manufactured in accordance with customary manufacturing practices; (vi) without limiting the generality of Section 6.26(a)(i6.23(a)(i) and (ii) above, with respect to any Product being tested or manufactured by any Loan Party or any Subsidiary of any Loan Partythe Borrower and its Subsidiaries, such Person has the Borrower and its Subsidiaries have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of the Borrower or such PersonSubsidiary, and such Person neither the Borrower nor any Subsidiary has not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of (A) such Person’s the Borrower and its Subsidiaries’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Applicable Law (including Healthcare Laws) and/or Laws or the Required Permits related to the manufacture of such Product, Product or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or or manufacturing of such Product by such Person the Borrower and its Subsidiaries should cease; (ivvii) Without without limiting the generality of Section 6.26(a)(i6.23(a)(i) and (ii) above, with respect to any Product marketed, leased, rented, marketed or sold by any Loan Party the Borrower or any Subsidiary of any Loan PartySubsidiary, such Person the Borrower and its Subsidiaries shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the provision, use, marketing and sales of such Product as currently being marketed, leased, rented, marketed or sold by such Personthe Borrower and its Subsidiaries, and such Person neither the Borrower nor any Subsidiary has not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and; (vviii) neither the Loan Parties and their Subsidiaries have not Borrower nor any Subsidiary has experienced any significant failures in their the manufacturing of any Product such that the amount of such Product successfully manufactured by them the Borrower or any of its Subsidiaries in accordance with all specifications thereof and any required payments the Required Permits related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.; and (cix) Neither none of the execution nor performance by any Loan Party Products is currently, and have not for the past six (6) years been, the subject of any Loan Documentsclaim or allegation, nor the exercise of formal or informal, that any remedies by Product, or its use, is defective or has resulted in or proximately caused any party thereunder, will adversely affect injury to any of the Required PermitsPerson or property.