Common use of Regulatory Reporting and Covenants Clause in Contracts

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five (5) Business Days of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (v) any Product recalls or voluntary Product withdrawals from any market which have or could reasonably be expected to result in a Material Adverse Effect or (vi) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five (5) 3 Business Days of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or its Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectChange), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse Effect, Change or (vvi) any Product recalls or voluntary Product withdrawals from any market which have or could reasonably be expected to result in a Material Adverse Effect or (vi) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly other than with respect to the quantities of such Product discrete batches or lots that are not material in quantity or amount and payments produced are not made in the prior month, in each case, which could reasonably be expected to result in conjunction with a Material Adverse Effectlarger recall) have occurred. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain and, to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain, all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse EffectChange. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Required Permits Schedule becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Required Permits Schedule including such updated information.

Regulatory Reporting and Covenants. (a) Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with notice of the occurrence of any of the following events (provided that if such event could reasonably be expected to have a Material Adverse Effect, Borrower shall notify provide Agent and each Lender promptly (and in any event with such notice within five (5) Business Days of receiving, becoming aware of or determining that any such event has occurred (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls or voluntary Product withdrawals from any market which have (other than discrete batches or could reasonably be expected to result lots that are not material in quantity or amount and are not made in conjunction with a Material Adverse Effect larger recall) or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Schedule 8.2(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.2(a) including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, or market any new Product, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 3.19 and Schedule 8.2(a) (Licensing and Products) (and copies of such Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) 10 Business Days Days, after receiving a written notice of receiving, or otherwise becoming aware of or determining that any of the following has occurred and would reasonably be expected to cause a Material Adverse Effect (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, an investigation of any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectBusiness), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the Credit Parties business of Borrower or its Subsidiaries (taken as a whole) should cease, (iii) if a Product that is material to the Credit Parties business of the Borrower or its Subsidiaries (taken as a whole) has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) adverse clinical test results with respect to any Product which have Regulatory Required Permit has been revoked or could reasonably be expected to result in a Material Adverse Effectwithdrawn, (v) any Product recalls or voluntary Product withdrawals from any market which (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred or (vi) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month quarter shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effectquarter. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall may reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of its material Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect. (c) If, after the Closing Date, Borrower manufactures, sells, develops, tests or markets any new Product substantially different than Borrower’s Products existing on the Closing Date, Borrower shall deliver prior written notice to Agent of the same (which shall include a brief description of such material Product).

Regulatory Reporting and Covenants. (a) The Borrower shall notify the Administrative Agent and each Lender promptly (promptly, and in any event within five ten (510) Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course ordinary course of Business business associated with the renewal of a Regulatory Required Permit and which could would not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product should cease which have or provision of any service that is material would reasonably be expected to the business of Borrower or its Subsidiaries should ceaseresult in a Material Adverse Effect, (iii) if a material Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) adverse clinical test results with respect to any Product Regulatory Required Permit has been revoked or withdrawn which have or could would reasonably be expected to result in a Material Adverse Effect, (v) adverse clinical test results with respect to any Product recalls or voluntary Product withdrawals from any market which have or could would reasonably be expected to result in a Material Adverse Effect or (vi) any significant failures Product recalls or voluntary Product withdrawals from any market (other than discrete batches or lots that are not material in the manufacturing of any Product such that the quantity or amount of such Product successfully manufactured and are not made in accordance conjunction with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effectlarger recall). The Borrower shall provide to the Administrative Agent or to any Lender such further information (including copies of such documentation) as the Administrative Agent or any such Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) The Borrower shall, and shall cause each Credit Loan Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Loan Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could would have a Material Adverse Effect. In the event that the Borrower or any Loan Party obtains any new Regulatory Required Permit or any information on Schedule 5.22(a) becomes materially outdated, inaccurate, incomplete or misleading, the Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide the Administrative Agent with an updated Schedule 5.22(a) including such updated information.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) 10 Business Days Days, after receiving a written notice of receiving, or otherwise becoming aware of or determining that any of the following has occurred and would reasonably be expected to cause a Material Adverse Effect (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, an investigation of any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the Credit Parties business of Borrower or its Subsidiaries (taken as a whole) should cease, (iii) if a Product that is material to the Credit Parties business of the Borrower or its Subsidiaries (taken as a whole) has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effectbeen obtained, (vvi) any Product recalls or voluntary Product withdrawals from any market which (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month quarter shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effectquarter. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall may reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new material Regulatory Required Permit or any information on the Schedule 8.2(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.2(a) including such updated information.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five ten (510) Business Days days of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or is Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectChange), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse EffectChange, (vvi) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred, or (vivii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain and, to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain, all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse EffectChange. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Required Permits Schedule becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Required Permits Schedule including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product (by itself or through a third party), Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate, shall provide an updated Intangible Assets Schedule, Products Schedule and Required Permits Schedule (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five three (53) Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): ): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or is Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), , (ii) any development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, Midcap / MannKind / Credit and Security Agreement (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, , (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse EffectChange, (vi) receipt by Borrower or any Subsidiary thereof from the FDA 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 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 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 to the extent that such correspondence or notice has or could reasonably be expected to result in a Material Adverse Change; (vvii) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect or occurred, or (viviii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting EventEvent promptly, but in any event within five (5) Business Days of, upon such request. (b) Borrower shall have, and shall ensure that it and each of its Subsidiaries has, each material Required Permit and other rights from, and have made all declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Borrower and Borrowers shall take reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Required Permit. Borrower shall ensure that all such Required Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Required Permits in all material respects. (c) Borrower will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Borrowers’ business and assets, all material Required Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. (d) In connection with the development, testing, manufacture, marketing or sale of each and any material Product, Borrower shall, and shall cause each Credit Party to, obtain and comply with all material Regulatory Required Permits necessary for compliance in at all material respects with Laws times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacturingmanufacture, developingmarketing or sales of such Product by such Borrower as such activities are at any such time being conducted by such Borrower. (e) Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), selling or marketing of Products all material notifications, reports, submissions, material Required Permit renewals and shall, reports required by applicable Healthcare Laws (which reports will be materially accurate and shall cause each Credit Party to, maintain and comply fully and completely complete in all respects with all such and not misleading in any respect and shall not remain open or unsettled). Midcap / MannKind / Credit and Security Agreement (f) In the event Borrower or any Credit Party obtains any new Regulatory Required PermitsPermit or any information on the Required Permits Schedule to the Disclosure Letter becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the noncompliance next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with which could have an updated Required Permits Schedule to the Disclosure Letter including such updated information (g) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product commercially (by itself or through a Material Adverse Effectthird party), Borrower shall deliver, together with delivery of the next Compliance Certificate shall provide an updated Intangible Assets Schedule to the Disclosure Letter, Products Schedule to the Disclosure Letter and Required Permits Schedule to the Disclosure Letter (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower Each Credit Party shall notify Agent and each Lender promptly (promptly, and in any event within five (5) Business Days of receiving, becoming aware of or determining that one of the following has occurred, in each case to the extent the same could reasonably be expected to have a Material Adverse Effect (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA and CMS, has provided written notice that it is conducting or has conducted (A) if applicable, an investigation regarding any of BorrowerCredit Party’s or its Subsidiaries’ manufacturing facilities and processes for any Product or clinical laboratories which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) adverse any Regulatory Required Permit has been revoked or withdrawn by a Governmental Authority, (v) clinical test study results reveal significant safety, efficacy or other issues with respect to any Product which have or could reasonably be expected to result in a Material Adverse EffectProduct, (vvi) any Product recalls Recalls or voluntary Product withdrawals Market Withdrawals from any market which have or could reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse EffectProduct. Borrower Each Credit Party shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. Notwithstanding the foregoing, no Credit Party shall be required to disclose any information that could result in the forfeiture of attorney client or similar privilege; provided, however, that such Credit Party shall take all actions reasonably requested by Agent to allow access to such document without otherwise forfeiting such privilege. (b) Borrower shallExcept as would not reasonably be expected to have a Material Adverse Effect, and shall cause each Credit Party to, shall obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products Medical Devices or the performance of LDTs and shall, other laboratory testing services and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five three (53) Business Days of receiving, upon receiving written notice or otherwise becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): ): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or is Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), , (ii) any development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, , (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, , (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse EffectChange, (vi) receipt by Borrower or any Subsidiary thereof from the FDA 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 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 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; (vvii) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect or occurred, or (viviii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting EventEvent promptly, but in any event within five (5) Business Days of, upon such request. (b) Borrower shallshall have, and shall ensure that it and each of its Subsidiaries has, each material Required Permit and other rights from, and have made all declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in the ownership, management and operation of the business or the assets of any Borrower and Borrowers shall ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Required Permit. Borrower shall ensure that all such Required Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Required Permits in all material respects. (c) Borrower will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Borrowers’ business and assets, all Required Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. (d) Each Borrower shall and shall cause each Credit Party to, obtain and comply with and, to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain and comply with, all Regulatory Required Permits necessary for compliance in at all material respects with Laws times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacturingmanufacture, developingmarketing or sales of such Product by such Borrower as such activities are at any such time being conducted by such Borrower. (e) Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), selling or marketing of Products all material notifications, reports, submissions, Required Permit renewals and shall, reports required by Healthcare Laws (which reports will be materially accurate and shall cause each Credit Party to, maintain and comply fully and completely complete in all respects with all such and not misleading in any respect and shall not remain open or unsettled). (f) In the event Borrower or any Credit Party obtains any new Regulatory Required PermitsPermit or any information on Schedule 5.8(b) of the Disclosure Letter becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the noncompliance next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 5.8(b) of the Disclosure Letter including such updated information. (g) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product (by itself or through a third party), Borrower shall deliver prior written notice to Agent of such determination (which could have shall include a Material Adverse Effectbrief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 5.7, Schedule 5.8(a) and Schedule 5.8(b) of the Disclosure Letter (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five three (53) Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or is Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectChange), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse EffectChange, (vvi) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred, or (vivii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain and, to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain, all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse EffectChange. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product (by itself or through a third party), Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate, shall provide an updated Intangible Assets Schedule reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) 3 Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, an inspection of any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation inspection has disclosed disclosed, and notification of which has been provided to Borrower in writing, of any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an a material investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal or maintenance of a Regulatory Required Permit and which could would not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (ivv) adverse clinical trial test results with respect to any Product which have or could would reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls Recalls or voluntary Product withdrawals from any market which have or could would reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the any required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could would reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could would have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new material Regulatory Required Permit or any information on the Schedule 8.2(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.2(a) including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 3.19 and Schedule 8.2(a) (Licensing and Products) (and copies of such Permits as Agent may request) reflecting updates related to such determination (a) MidCap / Aptevo Therapeutics / Amended and Restated Credit and Security Agreement \\DC - 036639/000031 - 12505399

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) 10 Business Days Days, after receiving a written notice of receiving, or otherwise becoming aware of or determining that any of the following has occurred and would reasonably be expected to cause a Material Adverse Effect (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, an investigation of any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the Credit Parties business of Borrower or its Subsidiaries (taken as a whole) should cease, (iii) if a Product that is material to the Credit Parties business of the Borrower or its Subsidiaries (taken as a whole) has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effectbeen obtained, (vvi) any Product recalls or voluntary Product withdrawals from any market which (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month quarter shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effectquarter. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall may reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new material Regulatory Required Permit or any information on the Schedule 8.2(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement with respect to last month of a fiscal quarter after such event, provide Agent with an updated Schedule 8.2(a) including such updated information.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five (5) 3 Business Days of receiving, becoming aware of or determining that (each, a “"Regulatory Reporting Event” " and collectively, the “"Regulatory Reporting Events”")): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s 's or its Subsidiaries’ ' manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectChange), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse EffectChange, (vvi) any Product recalls or voluntary Product withdrawals from any market which have (other than discrete batches or could reasonably be expected to result lots that are not material in quantity or amount and are not made in conjunction with a Material Adverse Effect larger recall) or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse EffectChange. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Regulatory Required Permits Schedule becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event provide Agent with an updated Regulatory Required Permits Schedule including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Intangible Assets Schedule, Products Schedule and Regulatory Required Permits Schedule (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five three (53) Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): ): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or is Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), , (ii) any development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, , (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, , (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse EffectChange, (vi) receipt by Borrower or any Subsidiary thereof from the FDA 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 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 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 to the extent that such correspondence or notice has or could reasonably be expected to result in a Material Adverse Change; (vvii) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have occurred, or could reasonably be expected to result in a Material Adverse Effect or Midcap / MannKind / Credit and Security Agreement (viviii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting EventEvent promptly, but in any event within five (5) Business Days of, upon such request. (b) Borrower shall have, and shall ensure that it and each of its Subsidiaries has, each material Required Permit and other rights from, and have made all declarations and filings with, all applicable Governmental Authorities, all self-regulatory authorities and all courts and other tribunals necessary to engage in all material respects in the ownership, management and operation of the business or the assets of any Borrower and Borrowers shall take reasonable actions to ensure that no Governmental Authority has taken action to limit, suspend or revoke any such Required Permit. Borrower shall ensure that all such Required Permits are valid and in full force and effect and Borrowers are in material compliance with the terms and conditions of all such Required Permits in all material respects. (c) Borrower will maintain in full force and effect, and free from restrictions, probations, conditions or known conflicts which would materially impair the use or operation of Borrowers’ business and assets, all material Required Permits necessary under Healthcare Laws to carry on the business of Borrowers as it is conducted on the Closing Date in all material respects. (d) In connection with the development, testing, manufacture, marketing or sale of each and any material Product, Borrower shall, and shall cause each Credit Party to, obtain and comply with all material Regulatory Required Permits necessary for compliance in at all material respects with Laws times issued or required to be issued by any Governmental Authority, specifically including the FDA, with respect to such development, testing, manufacturingmanufacture, developingmarketing or sales of such Product by such Borrower as such activities are at any such time being conducted by such Borrower. (e) Borrowers will timely file or caused to be timely filed (after giving effect to any extension duly obtained), selling or marketing of Products all material notifications, reports, submissions, material Required Permit renewals and shall, reports required by applicable Healthcare Laws (which reports will be materially accurate and shall cause each Credit Party to, maintain and comply fully and completely complete in all respects with all such and not misleading in any respect and shall not remain open or unsettled). (f) In the event Borrower or any Credit Party obtains any new Regulatory Required PermitsPermit or any information on the Required Permits Schedule to the Disclosure Letter becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the noncompliance next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with which could have an updated Required Permits Schedule to the Disclosure Letter including such updated information (g) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product commercially (by itself or through a Material Adverse Effect.third party), Borrower shall deliver, together with delivery of the next Compliance Certificate shall provide an updated Intangible Assets Schedule to the Disclosure Letter, Products Schedule to the Disclosure Letter and Required Permits Schedule to the Disclosure Letter (and copies of such Required Permits as Agent may request) reflecting updates related to such determination. Midcap / MannKind / Credit and Security Agreement

Regulatory Reporting and Covenants. (a) During any Non-Third Party Agent Retention Period, at any time after the Agent or any Lender has notified Borrower Representative in writing that it desires to receive such information until the Agent or such Lender notifies Borrower Representative in writing that it again desires not to receive such information, subject to Section 4.19, Borrowers shall notify Agent and each Lender Lender, or (b) during any Third Party Agent Retention Period, at all times, Borrowers shall notify the Third Party Agent, in each case of clause (a) and clause (b) above, promptly (and in any event within five (5) Business Days Days) of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product Product, which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit that is material to the business of the Borrower or its Subsidiaries has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls or voluntary Product withdrawals from any market (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall), which have or could reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) 3 Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, an inspection of any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation inspection has disclosed disclosed, and notification of which has been provided to Borrower in writing, of any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an a material investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal or maintenance of a Regulatory Required Permit and which could would not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower MidCap / Aptevo Therapeutics / Term Credit and Security Agreement \DC - 036639/000031 - 8550121 v15 or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (ivv) adverse clinical trial test results with respect to any Product which have or could would reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls Recalls or voluntary Product withdrawals from any market which have or could would reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the any required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could would reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could would have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new material Regulatory Required Permit or any information on the Schedule 8.2(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.2(a) including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 3.19 and Schedule 8.2(a) (Licensing and Products) (and copies of such Permits as Agent may request) reflecting updates related to such determination

Regulatory Reporting and Covenants. (a) Borrower The Credit Parties shall notify Agent and each Lender promptly (promptly, and in any event within five (5) Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrowerany Credit Party’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by any Credit Party or its Subsidiaries in respect of a Product of which investigation such Credit Party and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectChange), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which to the extent that such results have or could reasonably be expected to result in a Material Adverse EffectChange, (vvi) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred, or (vivii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower such Credit Party therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower The Credit Parties shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Each Credit Party toshall obtain and, obtain to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain, all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse EffectChange. In the event any Credit Party obtains any new Regulatory Required Permit or any information on the Required Permits Schedule becomes outdated, inaccurate, incomplete or misleading, the Credit Parties shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Required Permits Schedule including such updated information. (c) If, after the Closing Date, (i) any Credit Party determines to manufacture, sell, develop, test or market any new Product (by itself or through a third party), such Credit Party shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Intangible Assets Schedule, Products Schedule and Required Permits Schedule (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five (5) 3 Business Days of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”)): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectChange), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse EffectChange, (vvi) any Product recalls or voluntary Product withdrawals from any market which have (other than discrete batches or could reasonably be expected to result lots that are not material in quantity or amount and are not made in conjunction with a Material Adverse Effect larger recall) or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse EffectChange. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Regulatory Required Permits Schedule becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event provide Agent with an updated Regulatory Required Permits Schedule including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Intangible Assets Schedule, Products Schedule and Regulatory Required Permits Schedule (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five four (54) Business Days Days) of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product or service, which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business Business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit that is material to the business of the Borrower or its Subsidiaries has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls or voluntary Product withdrawals from any market (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall), which have or could reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products Products, except where the failure to so would not reasonably be expected to result in a Material Adverse Effect and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Schedule 8.1(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.1(a) including such updated information.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) 3 Business Days of receiving, becoming aware of or determining that that, (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, an inspection of any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product which investigation inspection has disclosed disclosed, and notification of which has been provided to Borrower in writing, of any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an a material investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal or maintenance of a Regulatory Required Permit and which could would not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) adverse clinical trial test results with respect to any Product which have or could would reasonably be expected to result in a Material Adverse Effect, (v) any Product recalls Recalls or voluntary Product withdrawals from any market which have or could would reasonably be expected to result in a Material Adverse Effect or (vi) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the any required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could would MidCap / Aptevo Therapeutics / Credit and Security Agreement reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all material respects with all such Regulatory Required Permits, the noncompliance with which could would have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new material Regulatory Required Permit or any information on the Schedule 8.2(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.2(a) including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new Product, Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and, together with delivery of the next Compliance Certificate shall provide an updated Schedule 3.19 and Schedule 8.2(a) (Licensing and Products) (and copies of such Permits as Agent may request) reflecting updates related to such determination

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five three (53) Business Days of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or its Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (v) any Product recalls or voluntary Product withdrawals from any market which the extent that such results have or could reasonably be expected to result in a Material Adverse Effect or (vi) any significant failures in the manufacturing of Product recalls or voluntary Product withdrawals from any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly market (other than with respect to the quantities of such Product discrete batches or lots that are not material in quantity or amount and payments produced are not made in the prior month, in each case, which could reasonably be expected to result in conjunction with a Material Adverse Effectlarger recall) have occurred. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain and, to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain, all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect.. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on Schedule 3.8 becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 3.8 including such updated information. 90315629_11

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (and in any event within five four (54) Business Days Days) of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product or service, which investigation has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related to such thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business Business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit that is material to the business of the Borrower or its Subsidiaries has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls or voluntary Product withdrawals from any market (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall), which have or could reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products Products, except where the failure to so would not reasonably MidCap / EndoChoice / Term Credit and Security Agreement be expected to result in a Material Adverse Effect and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect. In the event Borrower or any Credit Party obtains any new Regulatory Required Permit or any information on the Schedule 8.1(a) becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event, provide Agent with an updated Schedule 8.1(a) including such updated information.

Regulatory Reporting and Covenants. (a) Borrower Credit Parties shall notify Agent and each Lender promptly (and in any event within five (5) Business Days Days) of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA FDA, is conducting or has conducted (A) if applicable, any investigation of BorrowerCredit Party’s or its Subsidiaries’ manufacturing facilities and processes for any Product Product, which investigation has disclosed any resulted in allegations by the Governmental Authority of material deficiencies or material violations of Laws and/or the Regulatory Required Permits or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower Credit Parties or its their Subsidiaries (taken as a whole) should cease, (iii) if a Product that is material to the business of the Borrower Credit Parties or its their Subsidiaries (taken as a whole) has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit that is material to the business of Credit Parties or their Subsidiaries has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls or voluntary Product withdrawals Recalls of Products from any market (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a recall initiated by another Person), which have or could reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower Credit Parties therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower Credit Parties shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall may reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Each Credit Party to, shall obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects materially with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect.

Regulatory Reporting and Covenants. (a) Borrower shall notify Agent and each Lender promptly (promptly, and in any event within five (5) Business Days [***] of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA is conducting or has conducted (A) if applicable, any investigation of Borrower’s or its Subsidiaries’ manufacturing facilities and processes for any Product (or any investigation of the facility of a contract manufacturer engaged by Borrower or is Subsidiaries in respect of a Product of which investigation Borrower and/or its Subsidiaries are aware), which has disclosed any material deficiencies or violations of Laws and/or the Regulatory Required Permits related thereto or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse EffectPermit), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower or its Subsidiaries should cease, (iii) if a Product that is material to the business of the Borrower or its Subsidiaries has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit has been revoked or withdrawn, (v) adverse clinical test results have occurred with respect to any Product which have or could reasonably be expected to result in a Material Adverse EffectProduct, (vvi) any Product recalls or voluntary Product withdrawals from any market which (other than with respect to discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a larger recall) have or could reasonably be expected to result in a Material Adverse Effect occurred, or (vivii) any significant failures in the manufacturing of any Product have occurred such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each casecase of the foregoing clauses (i) – (vii), which to the extent that such event could reasonably be expected to result in a Material Adverse EffectChange. Borrower shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Credit Party to, obtain and, to the extent applicable, use commercially reasonable efforts to cause all third parties to obtain, all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects with all such Regulatory Required Permits, the noncompliance with which could have reasonably be expected to result in a Material Adverse EffectChange. In the event Borrower or any Credit Party obtains any new material Regulatory Required Permit or any information on the Required Permits Schedule becomes outdated, inaccurate, incomplete or misleading, Borrower shall, together with the next Compliance Certificate required to be delivered under this Agreement after such event or within [***], if earlier, provide Agent with an updated Required Permits Schedule including such updated information. (c) If, after the Closing Date, (i) Borrower determines to manufacture, sell, develop, test or market any new material Product (by itself or through a third party), Borrower shall deliver prior written notice to Agent of such determination (which shall include a brief description of such Product) and (x) if such determination occurs on or after March 31st and on or before September 30th of the applicable year, together with the Compliance Certificate to be delivered under this Agreement with respect to the period ending September 30th of such year, and (y) if such determination occurs after September 30th applicable year and on or before March 31st of the following year of the, together with the Compliance Certificate to be delivered under this Agreement with respect to the period ending March 31st of such year, shall provide an updated Intangible Assets Schedule, Products Schedule and Required Permits Schedule (and copies of such Required Permits as Agent may request) reflecting updates related to such determination.

Regulatory Reporting and Covenants. (a) Borrower Credit Parties shall notify Agent and each Lender promptly (and in any event within five (5) Business Days Days) of receiving, becoming aware of or determining that (each, a “Regulatory Reporting Event” and collectively, the “Regulatory Reporting Events”): (i) any Governmental Authority, specifically including the FDA FDA, is conducting or has conducted (A) if applicable, any investigation of BorrowerCredit Party’s or its Subsidiaries’ manufacturing facilities and processes for any Product Product, which investigation has disclosed any resulted in allegations by the Governmental Authority of material deficiencies or material violations of Laws and/or the Regulatory Required Permits or (B) an investigation or review of any Regulatory Required Permit (other than routine reviews in the Ordinary Course of Business associated with the renewal of a Regulatory Required Permit and which could not reasonably be expected to result in a Material Adverse Effect), (ii) development, testing, and/or manufacturing of any Product or provision of any service that is material to the business of Borrower Credit Parties or its their Subsidiaries (taken as a whole) should cease, (iii) if a Product that is material to the business of the Borrower Credit Parties or its their Subsidiaries (taken as a whole) has been approved for marketing and sale, any marketing or sales of such Product should cease or such Product should be withdrawn from the marketplace, (iv) any Regulatory Required Permit that is material to the business of Credit Parties or their Subsidiaries has been revoked or withdrawn, (v) adverse clinical test results with respect to any Product which have or could reasonably be expected to result in a Material Adverse Effect, (vvi) any Product recalls or voluntary Product withdrawals Recalls of Products from any market (other than discrete batches or lots that are not material in quantity or amount and are not made in conjunction with a Recall initiated by another Person), which have or could reasonably be expected to result in a Material Adverse Effect or (vivii) any significant failures in the manufacturing of any Product such that the amount of such Product successfully manufactured in accordance with all specifications thereof and the required payments to be made to Borrower Credit Parties therefor in any month shall decrease significantly with respect to the quantities of such Product and payments produced in the prior month, in each case, which could reasonably be expected to result in a Material Adverse Effect. Borrower Credit Parties shall provide to Agent or any Lender such further information (including copies of such documentation) as Agent or any Lender shall may reasonably request with respect to any such Regulatory Reporting Event. (b) Borrower shall, and shall cause each Each Credit Party to, shall obtain all Regulatory Required Permits necessary for compliance in all material respects with Laws with respect to testing, manufacturing, developing, selling or marketing of Products and shall, and shall cause each Credit Party to, maintain and comply fully and completely in all respects materially with all such Regulatory Required Permits, the noncompliance with which could have a Material Adverse Effect.