Common use of Healthcare and Regulatory Events Clause in Contracts

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program. (iv) To the knowledge of such Borrower, no Borrower’s 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). (v) No Borrower has received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (vi) No Borrower has received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authority. (vii) No Borrower has engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s business. (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program. (iv) To None of the knowledge of such Borrower, no Borrower’s 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 Reg. 46191 (September Sept. 10, 1991). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (vi) No Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect case, as would not reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authorityhave a Material Adverse Effect. (vii) No Borrower has not engaged in any Recalls, Market Withdrawals, Recalls or other forms of product retrieval any permanent withdrawals from the marketplace of any Product or Products that in the aggregate are material to the Borrower’s businessbusiness (or any event that could reasonably be expected to result in a permanent withdrawal from the marketplace). (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and LawsLaws except as would not reasonably be expected to have a Material Adverse Effect; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing PracticesPractices except as would not reasonably be expected to have a Material Adverse Effect.

Healthcare and Regulatory Events. (i) None of the Borrowers Credit Parties are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been are no unresolved Regulatory Reporting Events. (iii) No Borrower is participating Except as would not reasonably be expected to result in any Third Party Payor Program. (iv) To a Material Adverse Effect, none of the knowledge of such Borrower, no Borrower’s Credit Parties’ 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). (viv) No Borrower Except as would not reasonably be expected to result in a Material Adverse Effect, no Credit Party has received any written notice that any Governmental Authority, including without limitation the FDA, the DEACMS, the Office of the Inspector General of HHS or the United States Department of Justice or any foreign equivalent has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (viv) No Borrower Except as would not reasonably be expected to result in a Material Adverse Effect, no Credit Party has received from the FDA or the DEACMS, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEAFDA, CMS, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect to letters, notices or other correspondence received prior similar Governmental Authority related to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authorityProducts. (viivi) No Borrower Except as would not reasonably be expected to result in a Material Adverse Effect, no Credit Party has engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viiivii) Each Product Except as would not reasonably be expected to result in a Material Adverse Effect, each Medical Device (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance material compliance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance material compliance with Good Manufacturing PracticesQSR. (viii) Except as would not reasonably be expected to result in a Material Adverse Effect, each LDT (a) has been designed, developed, and performed in material compliance with CLIA and all applicable Permits and Laws.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not reasonably be expected to have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program. (iv) To the knowledge each Borrower’s knowledge, none of such Borrower, no Borrower’s 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). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (vi) No Except as would not reasonably be expected to result in a Material Adverse Effect, Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any foreign, state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA or the 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, except, in each instance with respect to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authority. (vii) No Except as would not reasonably be expected to result in a Material Adverse Effect, Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Except as would not reasonably be expected to result in a Material Adverse Effect, each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices.

Healthcare and Regulatory Events. Except as set forth in Schedule 8.2(d) to the Disclosure Letter: (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not reasonably be expected to have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program. (iv) To the knowledge each Borrower’s knowledge, none of such Borrower, no Borrower’s 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). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (vi) No Except as would not reasonably be expected to result in a Material Adverse Effect, Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any foreign, state or local authority responsible for regulating drug medical device products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authority. (vii) No Except as would not reasonably be expected to result in a Material Adverse Effect, Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Except as would not reasonably be expected to result in a Material Adverse Effect, each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; and (c) each Product in commercial distribution has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing PracticesQuality System regulations set forth at 21 CFR 820.

Healthcare and Regulatory Events. (i) None of the Borrowers Credit Parties are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting EventsEvents which could reasonably be expected to result in a Material Adverse Effect. (iii) No Borrower Credit Party is participating in any Third Party Payor Program. (iv) To the knowledge of such Borrowerany of Credit Party’s Responsible Officers, no Borrowernone of the Credit Party’s 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). (v) No Borrower has Within the last two years, Credit Parties 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 or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action, in each case, which could reasonably be expected to result in a Material Adverse Effect. (vi) No Borrower has Within the last two years, Credit Parties have not received from the FDA or the DEAFDA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEAFDA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA or DEAFDA, 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, except, in each instance with respect case, which could reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted result in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authoritya Material Adverse Effect. (vii) No Borrower has Within the last two years, Credit Parties have not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material which could reasonably be expected to the Borrower’s businessresult in a Material Adverse Effect. (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance in all material respects with all applicable Permits and Laws; and (dc) each Product has been and/or shall be manufactured in accordance material compliance with Good Manufacturing Practices, in each case, except where the failure to do so would not have a Material Adverse Effect.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not reasonably be expected to have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program, it being understood that agreements to provide discounts or rebates on drugs or biologics reimbursed by Third Party Payors is not participation in a Third Party Payor Program. (iv) To None of the knowledge of such Borrower, no Borrower’s 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 would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any material action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them as it may relate to Borrower’s business or for any material civil penalty, injunction, seizure or criminal action. (vi) No Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483FDA- 483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect case that would reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authorityhave a Material Adverse Effect. (i) MidCap / Aptevo Therapeutics / Amended and Restated Credit and Security Agreement \\DC - 036639/000031 - 12505399 (vii) No Borrower has not engaged in any material Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Product (a) is not materially adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, Section 505 or 512 of the FDCA; (c) each Product has been is being and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance material compliance with all applicable Permits and Laws; and (d) each Product has been is being and/or shall be manufactured in accordance material compliance with Good Manufacturing Practices.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not reasonably be expected to have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program, it being understood that agreements to provide discounts or rebates on drugs or biologics reimbursed by Third Party Payors is not participation in a Third Party Payor Program. (iv) To None of the knowledge of such Borrower, no Borrower’s 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 would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any material action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them as it may relate to Borrower’s business or for any material civil penalty, injunction, seizure or criminal action. (vi) No Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local MidCap / Aptevo Therapeutics / Term Credit and Security Agreement \DC - 036639/000031 - 8550121 v15 authority with regard to any Product or the manufacture, processing, packing, or holding thereof, except, in each instance with respect case that would reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authorityhave a Material Adverse Effect. (vii) No Borrower has not engaged in any material Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Product (a) is not materially adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, Section 505 or 512 of the FDCA; (c) each Product has been is being and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance material compliance with all applicable Permits and Laws; and (d) each Product has been is being and/or shall be manufactured in accordance material compliance with Good Manufacturing Practices.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting EventsEvents which could reasonably be expected to result in a Material Adverse Effect. (iii) No Borrower is participating in any Third Party Payor Program. (iv) To the knowledge of such any of Borrower’s Responsible Officers, no none of the Borrower’s 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). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action, in each case, which could reasonably be expected to result in a Material Adverse Effect. (vi) No Borrower has not received from the FDA or the DEAFDA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEAFDA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA or DEAFDA, 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, except, in each instance with respect case, which could reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted result in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authoritya Material Adverse Effect. (vii) No Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material which could reasonably be expected to the Borrower’s businessresult in a Material Adverse Effect. (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance in all material respects with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices, in each case, except where the failure to do so would not have a Material Adverse Effect.

Healthcare and Regulatory Events. (i) None of the Borrowers are The Borrower is not in violation of any material Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No The Borrower is not participating in any Third Party Payor Program. (iv) To the knowledge Knowledge of such the Borrower, no none of the Borrower’s 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 would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (v) No The Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Loan Party, any action to enjoin a Credit Loan Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (vi) No Except as set forth in Schedule 5.22(d)(vi), the Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authority. (vii) No Except as set forth in Schedule 5.22(d)(vii), the Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance material compliance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices, except where noncompliance would not have a Material Adverse Effect.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not reasonably be expected to have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting Events. (iii) No Borrower is participating in any Third Party Payor Program, it being understood that agreements to provide discounts or rebates on drugs or biologics reimbursed by Third Party Payors is not participation in a Third Party Payor Program. (iv) To None of the knowledge of such Borrower, no Borrower’s 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 would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991). (v) No Borrower 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 or the United States Department of Justice has commenced or threatened to initiate any material action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them as it may relate to Borrower’s business or for any material civil penalty, injunction, seizure or criminal action. (vi) No Borrower has not received from the FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect case that would reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authorityhave a Material Adverse Effect. (vii) No Borrower has not engaged in any material Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Product (a) is not materially adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, Section 505 or 512 of the FDCA; (c) each Product has been is being and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance material compliance with all applicable Permits and MidCap / Aptevo Therapeutics / Credit and Security Agreement Laws; and (d) each Product has been is being and/or shall be manufactured in accordance material compliance with Good Manufacturing Practices.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting EventsEvents which could reasonably be expected to result in a Material Adverse Effect or is subject to a Corporate Integrity Agreement. (iii) No Borrower is participating in any Third Party Payor ProgramProgram other than Medicare and Medicaid. (iv) To the knowledge of such any of Borrower’s Responsible Officers, no none of the Borrower’s 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). (v) No Borrower has not received any written notice that any Governmental Authority, including without limitation the FDA, the CMS, the DEA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action., in each case, which could reasonably be expected to result in a Material Adverse Effect. MidCap / EndoChoice / Term Credit and Security Agreement (vi) No Borrower has not received from the FDA FDA, the CMS or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect case, which could reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted result in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authoritya Material Adverse Effect. (vii) No Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material which could reasonably be expected to the Borrower’s businessresult in a Material Adverse Effect. (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices, in each case, except where the failure to do so would not have a Material Adverse Effect.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, including (but not limited to), any federal or state Law regulating (A) fraud and abuse, (B) referral and financial relationships with providers, (C) quality, (D) safety, (E) privacy, (F) security and (G) disclosure of payments under the Physician Payment Sunshine Act, except where any such violation would not reasonably be expected to have individually or in the aggregate a Material Adverse Effect. (ii) As of the Closing Date, there have been are no Regulatory Reporting Events. (iii) All Products, manufactured, tested, investigated, developed, prepared, packaged, labeled, distributed, sold, advertised or marketed by or on behalf of the Borrower have been and are being, manufactured, tested, developed, investigated, prepared, packaged, labeled, distributed, sold, advertised and marketed in material compliance with the Healthcare Laws, including, without limitation, human subject research, applicable study protocols, product approval or clearance, good manufacturing and good clinical practices, labeling, advertising, promotion and adverse event reporting. No Borrower is participating has introduced into commercial distribution any Products manufactured by or on behalf of any Borrower or distributed any 90315629_11 Products on behalf of any other Person that were upon their shipment by any Borrower adulterated or misbranded in any Third Party Payor Programviolation of 21 U.S.C. § 331. (iv) To the knowledge None of such Borrower, no ’s officers or directors or to the Borrower’s officers, directors, knowledge employees, shareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the CMS or FDA or failed to disclose a material fact required to be disclosed to the CMS or FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to violate any fraud or abuse requirements of the CMS or 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), in each case with respect to the Borrower or any Products or related services. (v) No Borrower has not received any written notice that any Governmental Authority, including without limitation the CMS, FDA, the DEA, the Office of the Inspector General of HHS Health and Human Services or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action. (vi) No Borrower has not received from the CMS or FDA or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the CMS or FDA or the DEA, or any comparable correspondence from any foreign, state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the CMS or FDA 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, distribution, packing, or holding thereof, except, in each instance with respect . Borrower does not have any current Product or manufacturing site (whether owned by the Borrower or that of a contract manufacturer) subject to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted in such letter, notice or other correspondence has been resolved to the satisfaction of a Governmental Authority (including the FDA) shutdown, DEAseizure, import or any comparable state, local or foreign authorityexport prohibition. (vii) No Except as would not reasonably be expected to result individually or in the aggregate a Material Adverse Effect, Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material to the Borrower’s businessProducts. (viii) Each Except as would not reasonably be expected to result in individually or in the aggregate a Material Adverse Effect, each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices.

Healthcare and Regulatory Events. (i) None of the Borrowers are in violation of any Healthcare Laws, except where any such violation would not have a Material Adverse Effect. (ii) As of the Closing Date, there have been no Regulatory Reporting EventsEvents which could reasonably be expected to result in a Material Adverse Effect or is subject to a Corporate Integrity Agreement. (iii) No Borrower is participating in any Third Party Payor ProgramProgram other than Medicare and Medicaid. (iv) To the knowledge of such any of Borrower’s Responsible Officers, no none of the Borrower’s 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). (v) No Borrower has not received any written notice that any Governmental Authority, including without limitation the FDA, the CMS, the DEA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, or, to Borrower’s knowledge, their officers, directors, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action, in each case, which could reasonably be expected to result in a Material Adverse Effect. (vi) No Borrower has not received from the FDA FDA, the CMS or the DEA, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth allegedly objectionable observations or alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA 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, except, in each instance with respect case, which could reasonably be expected to letters, notices or other correspondence received prior to the Closing Date, where such observations or violations noted result in such letter, notice or other correspondence has been resolved to the satisfaction of the FDA, DEA, or any comparable state, local or foreign authoritya Material Adverse Effect. (vii) No Borrower has not engaged in any Recalls, Market Withdrawals, or other forms of product retrieval from the marketplace of any Products that are material which could reasonably be expected to the Borrower’s businessresult in a Material Adverse Effect. (viii) Each Product (a) is not adulterated or misbranded within the meaning of the FDCA; (b) is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (c) each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed and each service has been conducted in accordance with all applicable Permits and Laws; and (d) each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices, in each case, except where the failure to do so would not have a Material Adverse Effect.