Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. (a) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.

Regulatory Matters. (a) Each of CZFS, CZFSAC NBT and FCCB NBT Bank has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 2022 with any Governmental Authority, Authority and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC NBT and/or FCCBNBT Bank, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFSNBT, investigation into the business or operations of CZFS, CZFSAC NBT and/or FCCBNBT Bank, since January 1, 20202022. FCCB There is no unresolved violation or matter requiring attention by any Governmental Authority with respect to any report or statement relating to any examinations of NBT Bank. Each of NBT and NBT Bank is “well-capitalized” as defined in applicable laws and regulations, and FCCB NBT Bank has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since Since January 1, 20202022, CZFS NBT has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFSNBT, FCCB NBT Bank nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or institutions engaged in the insurance of deposits (including, without limitation, the PADOBS OCC and the FRB) or the supervision or regulation of it. Neither CZFS NBT nor FCCB NBT Bank has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing Without limiting the generality of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter XSection 8.10(b), the USA PATRIOT Act, and parties acknowledge that this Section 4.11 is subject to the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department limitations of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (cSection 8.10(b) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderhereof.

Regulatory Matters. (a) Each Iris and each of CZFSits Subsidiaries are, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 have been, in compliance in all respects with all applicable Laws, including the FDCA and any other similar Laws administered or promulgated by the FDA or other comparable Governmental AuthorityEntity, except for any noncompliance which would not have an Iris Material Adverse Effect. Without limiting the foregoing, the Iris Products have been manufactured, packaged, labeled, tested, stored, shipped, handled, warehoused, and has paid distributed in accordance with all fees applicable Laws and assessments due Iris Permits (as defined below), commensurate with the Iris Products’ stage of development, and payable in connection therewithare not and have not been adulterated, misbranded, or prohibited from introduction into interstate commerce under applicable Law. Except for normal examinations conducted To Iris’s Knowledge, as of the date hereof no investigation, inspection, claim, suit, proceeding, audit or other action by any Governmental Authority in the regular course Entity is pending or threatened against Iris or any of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterits Subsidiaries. (b) Other than There is no agreement, judgment, injunction, order or decree binding upon Iris or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any material business practice of Iris or any of its Subsidiaries, any acquisition of material property by Iris or any of its Subsidiaries or the conduct of any material portion of the business by Iris or any of its Subsidiaries as set forth in CZFS Disclosure Schedule 4.11currently conducted, (ii) is reasonably likely to have a material adverse effect on Xxxx’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Contemplated Transactions. (c) Iris and its Subsidiaries have at all times since January 1, 20202020 held and have operated in compliance with all Governmental Authorizations that are necessary for the conduct of the business of Iris and its Subsidiaries as currently being conducted (the “Iris Permits”), CZFS has except where such failures to hold or remain so in compliance would not have an Iris Material Adverse Effect. All such Iris Permits are valid and are in full force and effect, and, assuming the notices, filings or other Consents listed on Section 3.16(c) of the Iris Disclosure Schedule have been made or obtained, will continue to be so upon consummation of the Contemplated Transactions, except as would not have an Iris Material Adverse Effect. (d) Section 3.15(d) of the Iris Disclosure Schedule identifies each Iris Permit. Iris and its Subsidiaries hold all right, title and interest in and to all Iris Permits free and clear of any Lien. All fees and charges with respect to such Iris Permits, as of the date hereof, have been paid in full and all filing, reporting and maintenance obligations have been completely and timely filed satisfied, except as would not have an Iris Material Adverse Effect. Iris and each of its Subsidiaries are in material compliance with the SEC terms of the Iris Permits. To Iris’s Knowledge, as of the date hereof no Legal Proceeding is pending or threatened, which seeks to revoke, limit, suspend, or materially modify any Iris Permit. (e) To Iris’s Knowledge, as of the date hereof there are no proceedings pending or threatened with respect to an alleged material violation by Iris or any of its Subsidiaries of the FDCA or any other similar Law administered or promulgated by any comparable Governmental Entity. As of the date hereof, neither Iris, any of its Subsidiaries nor to Iris’s Knowledge, any Person providing services to Iris or any of its Subsidiaries with respect to Iris’s product candidate eganelisib and NASDAQ currently contemplated uses (the “Iris Products”) has received any written notice, including any warning letter, untitled letter, cyber letter, FDA Form-483, Establishment Inspection Report, written notice of other adverse finding, notice of integrity review, notice of investigation, request for corrective or remedial action, or notice of deficiency or violation, or similar written communication from the FDA or any other Governmental Entity alleging that Iris or its Subsidiaries, their respective operations, or the Iris Products are in material violation of any applicable Law or Iris Permit. (f) No Iris Product has been or has been requested by a Governmental Authority or other Person to be recalled, withdrawn, removed, suspended, seized, the subject of a corrective action, or discontinued (whether voluntarily or otherwise) (collectively “Recall”). Neither Iris, nor, to Iris’s Knowledge, any Governmental Authority or other Person, has sought, is seeking, or, to Iris’s Knowledge, has or is currently threatening or contemplating any Recall of an Iris Product. (g) As required under applicable Law or pursuant to a Governmental Authorization, Iris and its Subsidiaries have maintained, filed, or furnished to the applicable Governmental Entities or Person all documents required by the Securities Act and the Exchange Act and such filings, documents, as claims, reports, notices, and other submissions (the same may have been amended“Reports”), compliedrequired to be maintained, filed, or furnished on a timely basis, and, at the time filed with of maintenance, filing, or furnishing all such Reports were complete and accurate when submitted, or were subsequently updated, changed, corrected, or modified, except where the SECfailures to so maintain, file, furnish, update, change, correct or modify would not have an Iris Material Adverse Effect. (h) Neither Iris, its Subsidiaries, nor to Iris’s Knowledge, any Person providing services to Iris or its Subsidiaries has made an untrue statement of a material fact or fraudulent statement to the FDA or a Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or a Governmental Entity, or made a statement, or failed to make a statement that, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto (the “FDA Ethics Policy”). Neither Iris, its Subsidiaries, nor to Iris’s Knowledge, any Person providing services to Iris or its Subsidiaries has ever been investigated by the FDA or other Governmental Entity for data or healthcare program fraud. Neither Iris, its Subsidiaries, nor to Iris’s Knowledge, any Person providing services to Iris or its Subsidiaries is the subject of any pending or, to Iris’s Knowledge, threatened investigation pursuant to the FDA Ethics Policy, or resulting from any other untrue or false statement or omission. (i) Neither Iris, its Subsidiaries, nor any Person providing services to Iris or its Subsidiaries, nor their respective officers, directors, partners, employees, or agents have been: (i) debarred or suspended pursuant to 21 U.S.C. § 335a; (ii) excluded under 42 U.S.C. § 1320a-7 or any similar law, rule or regulation of any Governmental Entity; (iii) excluded, debarred, suspended or deemed ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration; (iv) charged, named in a complaint, convicted, or otherwise found liable in any Legal Proceeding that falls within the ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 000x, 00 X.X.X. § 000x, 00 X.X.X. § 0000x – 7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other applicable Law; (v) disqualified or deemed ineligible pursuant to 21 C.F.R. Parts 312, 511, or 812, or otherwise restricted, in whole or in part, or subject to an assurance; or (vi) had a pending Legal Proceeding, or otherwise received any written notice from any Governmental Entity or any Person threatening, investigating, or pursuing (i)-(v) above. (j) Iris has not been restrained by a Governmental Authority nor other Person in its ability to conduct or have conducted the manufacturing, operation, storage, import, export, distribution, warehousing, packaging, labeling, handling, shipping, and/or nonclinical, clinical, or other testing of the Iris Products. (k) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Iris or any of its Subsidiaries, or in which Iris or any of its Subsidiaries or the Iris Products has participated were and, if still pending, are being conducted in compliance in all material respects with all applicable Laws and regulations enforced by the Securities Act FDA or any comparable Governmental Entity, including, to the extent applicable, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812. The study reports, protocols, and statistical analysis plans for all such studies and tests accurately, completely, and fairly reflect the Exchange Actresults from such studies and tests. Xxxx has not received written notice of any complaints, information, or adverse drug experience reports related to an Iris Product that would have an Iris Material Adverse Effect. (cl) Neither CZFSAs of the date hereof, FCCB neither Iris, its Subsidiaries, nor to Iris’s Knowledge, any Person providing services to Iris or its Subsidiaries has received any written notice, correspondence, or other written communications from the FDA, any other Governmental Entity, any Institutional Review Board (“IRB”), or other Person or board, such as, but not limited to, a data safety monitoring board, responsible for the oversight of the conduct of any study conducted by or on behalf of, or sponsored by, Iris or any of their respective properties its Subsidiaries, or in which Iris or the Iris Products is a party to participating, requiring or threatening the termination, hold, material adverse modification or suspension of any clinical study that is being or is subject proposed to any Regulatory Order from any Governmental Authority charged be conducted. All clinical studies conducted or sponsored by or on behalf of Iris or its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitationall applicable Laws, the PADOBS protocols, procedures and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bycontrols designed and approved for such studies, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement and in accordance with any individual requirement of an IRB or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS other Person or FCCB been advised in writing board responsible for review or oversight of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersuch studies.

Regulatory Matters. (a) Each of CZFSExcept as expressly set forth in Section 8.10 or the Transition Services Agreement, CZFSAC from and FCCB has timely filed after the Closing, Purchaser, at its cost, shall be solely responsible and liable for (i) taking all reportsactions, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid paying all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any conducting all communication with the appropriate Governmental Authority required by Applicable Law in the regular course respect of the business Regulatory Approvals, including preparing and filing all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority (whether the Product is sold before or after transfer of CZFSsuch Regulatory Approval), CZFSAC and/or FCCB(ii) taking all actions and conducting all communication with third parties in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), no Governmental Authority has initiated any proceedingincluding responding to all complaints in respect thereof, including complaints related to tampering or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulationscontamination, and FCCB has a Community Reinvestment Act rating (iii) investigating all complaints and adverse drug experiences in respect of “satisfactory” the Product sold pursuant to such Regulatory Approval (whether sold before or betterafter transfer of such Regulatory Approval). (b) Other than as set forth From and after the Closing, and subject to Section 8.10 hereof and the Transition Services Agreement, Seller promptly (and in CZFS Disclosure Schedule 4.11any event within the time periods required by Applicable Law) shall notify Purchaser within three (3) Business Days if Seller receives a complaint or a report of an adverse drug experience in respect of the Product. In addition, since January 1, 2020, CZFS has timely filed Seller shall cooperate with Purchaser’s reasonable requests and use commercially reasonable efforts to assist Purchaser in connection with the SEC investigation of and NASDAQ all documents required response to any complaint or adverse drug experience related to the Product sold by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActSeller. (c) Neither CZFSFrom and after the Closing, FCCB nor any Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of their respective properties is a party units of the Product sold pursuant to such Regulatory Approval (whether sold before or is subject to any after transfer of such Regulatory Order from Approval), including recalls required by any Governmental Authority charged and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Inventory, and reasonable credits extended to customers in connection with the supervision or regulation of financial institutions or issuers of securities or engaged recall. Seller shall notify Purchaser promptly in the insurance event that a recall of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority Product sold by Seller is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordernecessary. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofSeller shall, nor has CZFS or FCCB been advised in writing of or has any reason to believe within fifteen (based on CZFS’s Home Mortgage Disclosure Act data for 15) days after the year ended December 31Closing, 2021, filed with notify the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation FDA of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department transfer of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) Regulatory Approvals to be deemed not to be Purchaser in material compliance accordance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderApplicable Laws.

Regulatory Matters. (a) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted All existing Registrations held by any Governmental Authority in the regular course Reliant as of the business date of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as this Agreement are set forth in CZFS Disclosure Schedule 4.111.1.102. Reliant is the sole and exclusive owner of the Registrations. Reliant has delivered to the Purchaser true and correct copies of the Registrations and has made available to the Purchaser copies of material written communications between Reliant, since January 1, 2020, CZFS has timely filed with on the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAone hand, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, FDA or any other applicable anti-money laundering statuteMedical Product Regulatory Authority, rule on the other hand, since October 11, 2000 (the “Reliant Acquisition Date”), and any existing written summaries of material discussions between Reliant and the FDA or regulation; or (c) to be deemed not to be in material compliance with any other applicable Medical Product Regulatory Authority since the applicable requirements contained in any federal and state privacy or data security laws and regulationsReliant Acquisition Date, including, without limitation, copies of (i) all warning letters, FD-483s, notices of adverse findings and similar correspondence received by Reliant from the FDA since the Reliant Acquisition Date, (ii) all audit reports relating to audits for compliance with the Act performed since the Reliant Acquisition Date and submitted to the FDA; (iii) any document concerning any significant oral or written communication received from the FDA by Reliant (whether directly or via any third party) since the Reliant Acquisition Date; and (iv) any written notification from the FDA or any other applicable Medical Product Regulatory Authority indicating that the Product is misbranded or adulterated as defined in Title V the Act. Reliant has delivered any of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as foregoing materials sent to or received by the provisions third party manufacturer of the information security program adopted by CZFS pursuant Product that are currently in Reliant’s possession. (b) The promotion, distribution, marketing and sale and, to 12 C.F.R. Part 000Reliant’s Knowledge, Xxxxxxx Xmanufacture of the Product in the Territory has been conducted in compliance with the Registrations and all applicable Laws, Xxxxxxxx D. Furthermoreincluding the Act and the PDM Act. The Registrations required for the manufacturing, promotion, marketing, sale and distribution of the CZFS Board Product in the Territory are in full force and effect. (c) There are no proceedings pending against Reliant or, to Reliant’s Knowledge, threatened which could result in the revocation, cancellation or suspension of any Registrations listed in Schedule 1.1.102. (d) Reliant is in compliance in all material respects with all Laws applicable to the ownership, operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing of the Product and the Acquired Assets and, to the Knowledge of Reliant, has adopted not received any notice that any non-compliance of the foregoing or any notice of manufacturing non-compliance is being alleged, in each case except to the extent that such non-compliance has been remedied or to the extent the failure to comply therewith has not had a Material Adverse Effect. (e) Reliant has not received any written or, to Reliant’s Knowledge, other notice of proceedings from a Governmental Authority alleging that the Product or any of the Acquired Assets or the ownership, manufacturing, operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing thereof is in violation of any applicable Law and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that such violation has not been deemed ineffective remedied, except for such violations that would not reasonably be expected to have Material Adverse Effect. (f) Reliant has completed and timely filed all annual or other reports required by any Governmental the FDA or other Medical Product Regulatory Authority and that meets in order to maintain the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderRegistrations.

Regulatory Matters. (a) Each Sanofi shall be solely responsible for all regulatory filings and communications with each Regulatory Health Authority including, without limitation, for the preparation and filing of CZFSall INDs and applications for pricing and reimbursement approval and for providing, CZFSAC in the format required by Regulatory Health Authorities, the data and FCCB has timely filed all reports, registrations and statements, together with any amendments information required to be made with respect theretosubmitted to such Regulatory Health Authorities as part of a Drug Approval Application for a Program Product, that it was including data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Program Product by the Regulatory Health Authorities. Sanofi shall own all right, title and interest in and to file since January 1any Regulatory Filings and all Regulatory Approvals relating to the Program Compounds or Program Products and they shall be held in the name of Sanofi or its designated Affiliate, 2020 with any Governmental AuthoritySanofi Licensee, Sublicensee or other designee. Ardelyx shall duly execute and has paid all fees deliver or cause to be duly executed and assessments due delivered, such instruments and payable shall, at Sanofi’s cost and expense, do and cause to be done such acts and things, including the filing of such assignments, agreements, documents and instruments, as may be necessary under or as Sanofi may reasonably request in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, with or to carry out more effectively the Knowledge purpose of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws to better assure and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterconfirm unto Sanofi its rights under this Section 4.5(a). (b) Other than as set forth During the Term, through the DAC, or otherwise, if the DAC has been terminated pursuant to Section 3.2, Sanofi shall report to Ardelyx regarding the status of each pending or proposed IND application or Drug Approval Application covering a Program Product in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActTerritory. (c) Neither CZFSIf Ardelyx has exercised the Co-Promote Option (as described in Section 5.1 below) the following provisions of this Section 4.5(c) shall apply during the term of the [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. Co-Promote Agreement: Sanofi shall keep Ardelyx informed on an ongoing basis regarding the schedule and process for the preparation of the Drug Approval Application in respect of the relevant Co-Promote Product in the U.S. Territory, FCCB nor provide final (or close to final) drafts of those sections of the Drug Approval Application requested by Ardelyx, and permit Ardelyx to review and comment on sections of such drafts in parallel with Sanofi’s review process and in compliance with the timelines Sanofi has stipulated for its internal purposes, and Sanofi shall use reasonable efforts to incorporate Ardelyx’s comments therein. Notwithstanding the aforesaid, if the Parties are unable to achieve a consensus regarding any comments made or changes proposed by Ardelyx, Sanofi shall make the final determination as to whether and when to file the Drug Approval Application as well as the form and content thereof. The purpose of their respective properties is such foregoing interactions shall be to identify and resolve any potential reasonable concerns of Ardelyx in advance of the proposed filing of such Drug Approval Applications (and in particular the initial Drug Approval Application) in the U.S. Territory. Following the filing of the initial Drug Approval Application in the U.S. Territory, Sanofi shall continue to work with Ardelyx in the manner outlined above in this Section 4.5(c) in connection with any subsequent Drug Approval Applications in the U.S. Territory for the Co-Promote Product in respect of which Ardelyx has exercised the Co-Promote Option, and Sanofi shall provide Ardelyx with a party copy in electronic form of all filings to Regulatory Health Authorities in the U.S. Territory that it makes hereunder in connection with such foregoing Drug Approval Applications. Sanofi shall further promptly furnish Ardelyx with copies of all material correspondence or is subject minutes from any material meetings with any Regulatory Health Authority, in each case relating to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged such Drug Approval Application in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderU.S. Territory. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB If Ardelyx has any Knowledge ofexercised the Co-Promote Option, nor has CZFS or FCCB been advised in writing the following provisions of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for this Section 4.5(d) shall apply during the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation term of the federal Bank Secrecy Act, as amended, Co-Promote Agreement: Sanofi shall notify Ardelyx of any request for [***] and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued Sanofi shall allow [***]. The foregoing shall apply with respect to anti[***]. Sanofi shall as soon as reasonably practicable furnish Ardelyx with copies of all substantive correspondence Sanofi has had with the FDA, and contact reports concerning substantive conversations or substantive meetings with the FDA, in each case relating to any such Drug Approval Application for a Co-money laundering by Promote Product. (e) If Ardelyx has exercised the Co-Promote Option, and any Regulatory Health Authority threatens or initiates any action to remove a Co-Promote Product from the market in the U.S. Department Territory, Sanofi shall notify Ardelyx of such communication as promptly as reasonably practical under the Treasury’s Office of Foreign Assets Controlcircumstances, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained but in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V event within [***] of receipt of such communication from the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderRegulatory Health Authority.

Regulatory Matters. (a) Each Cipher shall be responsible for (i)matters relating to the maintenance of CZFSthe Regulatory Approvals for the Product, CZFSAC including compliance with all Regulatory Requirements and FCCB has otherwise keeping the Product NDA in force, and (ii) all communications with the Regulatory Authorities associated with the Product NDA including all ADE reporting and periodic safety update reporting (“PSUR”). Distributor shall be responsible for providing on a timely filed basis all reports, registrations and statements, together necessary documentation needed for all regulatory filings relating to the Marketing of the Product in the Territory with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental the Regulatory Authority, and has paid including all fees and assessments due and payable in connection therewithpharmacovigilance data needed for PSUR. Except Notwithstanding the foregoing, Distributor will be responsible for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or pharmacovigilance spontaneous reporting to the Knowledge of CZFS, investigation into Regulatory Authority with a copy to Cipher and Distributor will provide information necessary for submission by Cipher to the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterRegulatory Authorities. (b) Other than Distributor shall he responsible for all remaining pharmacovigilance activities in the Territory, including receiving, monitoring, responding promptly to, tracking, or as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents may otherwise be required by applicable Law and Regulatory Authority, all Product-related inquiries, Product quality complaints, and ADE reports received by Distributor, its Affiliates or SubDistributors or by Cipher (and which Cipher shall have forwarded to Distributor) from individuals and/or health care professionals from within the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActTerritory. (c) Neither CZFSAll communications by either Party with the Regulatory Authority in each jurisdiction in the Territory relating to the Product as Marketed in the Territory shall on a timely basis be provided in writing to the other Party, FCCB nor any and each Party shall provide on a timely basis to the other Party (i) copies of their respective properties is a party all documents sent to or is subject to any received from the Regulatory Order from any Governmental Authority charged with regarding the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS Product and the FRBNDA and (ii) notice of any proposed calls or meetings with a Regulatory Authority relating to the supervision Product or regulation of itNDA. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise Cipher shall provide an opportunity to an advisory notice by, any Governmental Authority that discuss with Distributor topics relevant to such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordercalls and meetings and consider in good faith Distributor’s interest with regard to such matters. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data [***] shall be responsible for Prescription Drug User Fees for the year ended December 31, 2021, filed Product (excluding establishment fees) associated with the FDICmaintenance of Regulatory Approval of the Product during the Term, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance commencing with the CRA2011 fiscal year (October 1st 2010 through September 30, and 2011) and, if applicable, shall reimburse [***] for any such Prescription Drug User Fees for the regulations promulgated thereunder, or to be assigned a rating for CRA purposes Product paid by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued [***] with respect to anti-money laundering any fiscal year within [***] days of receiving an invoice from [***]. Notwithstanding the foregoing, provided the [***] is made to [***] by the U.S. Department no later than June 30, 2011, [***] may postpone reimbursement of the Treasury’s Office Prescription Drug User Fees for the 2011 fiscal year until the earlier of Foreign Assets Controlthirty (30) after the First Commercial Sale, or September 30, 2011. [***] shall be responsible for Prescription Drug User Fees for the Product, if any, for fiscal years prior to the 2011 fiscal year. [***] shall also be solely responsible for establishment fees related to the manufacture of the Product to the extent it is responsible for manufacturing the Product. (e) Distributor shall be responsible for all matters relating to the Other Approvals for the Product including filing the Product with, maintaining the Product on and dealing with, any other applicable anti-money laundering statutefederal, rule state, or regulation; or (c) private formularies. Distributor will apply for and will hold the Other Approvals in Distributor’s name at all times for the benefit of Cipher. Distributor shall be responsible for all regulatory filings relating to be deemed not to be in material compliance the Product with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderOther Authorities.

Regulatory Matters. (a) Each of CZFSAt all times during the Term, CZFSAC LL shall maintain the production facility, equipment and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits processes (including, without limitation, the PADOBS process used in producing the Product and in performing LL’s other obligations under this Agreement) in compliance with this Agreement, the FRBQuality Agreement and all Applicable Laws (including, without limitation, cGMP, the FDA and, to the extent applicable, the EMA guidelines, employment and labor law requirements, electrical, fire and safety at work codes and regulations and guidelines issued by any applicable Drug Regulatory Authorities in the Territory). LL shall make available for inspection, upon the request of Cadence, all documentation relating to such compliance. (b) LL shall permit representatives of Cadence to conduct inspections from time to time at all Facilities utilized by LL and its Affiliates hereunder to manufacture the Product, as agreed between the Parties in the Quality Agreement. (c) If either Party is notified that the Product manufactured at the Facility or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise Facility will be subject to an advisory notice byinspection by FDA or any other Drug Regulatory Authority, such Party shall as soon as possible notify the other Party by telephone and e-mail of its receipt of such notification. LL shall provide Cadence copies of all Drug Regulatory Authority-issued inspection observation reports (including, without limitation, Form 483s and equivalent forms from other Drug Regulatory Authorities) and correspondence, purged only of confidential information that is unrelated to the Product. LL shall permit Cadence’s quality assurance representative to be present at the Facility during any Governmental such inspection by FDA or any other Drug Regulatory Authority that relates to the Product or LL’s performance under this Agreement, provided, however, that Cadence shall only have access to or communicate with the inspectors during the facility inspection as permitted under the Quality Agreement. LL will also notify Cadence as soon as possible of LL’s receipt of any other Form 483’s or warning letters or any other significant regulatory action which LL’s quality assurance group determines could impact the regulatory status of the Product. LL and Cadence will cooperate in resolving any concerns with any Drug Regulatory Authority, and Cadence may review LL’s responses to any such Governmental reports and communications. LL will in its reasonable discretion incorporate into such responses any comments received from Cadence. LL will also inform Cadence of any action taken by any Drug Regulatory Authority is contemplating issuing against LL or requesting (any of its officers or is considering employees which may be reasonably expected to adversely affect the appropriateness of issuing Product or requesting) any Regulatory OrderLL’s ability to supply the Product hereunder within [***]. (d) Neither CZFS nor FCCB is a party LL hereby grants Cadence the right to reference any agreement with any individual drug master file regarding the Product or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised similar regulatory filing in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDICTerritory that may now exist, or otherwise) that may exist at any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with time during the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, Supply Term or any other applicable anti-money laundering statuteextension thereof, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all regulatory or other applicable provisions filings made by or on behalf of Cadence, its Affiliates or sublicensees. Upon the USA PATRIOT Act and the regulations thereunderrequest of Cadence, LL shall provide Cadence with a letter evidencing such right of reference.

Regulatory Matters. 4.1 Company shall comply with all applicable laws and regulations in relation to the manufacturing and handling of the Product in the Territory and in any country outside the Territory where Company manufactures Product or has Product manufactured on its behalf. Distributor shall comply with all applicable regulations and laws in relation to the handling, storage, distribution and sale of the Product in those areas of the Territory where the Product is distributed and sold by Distributor. 4.2 Each Party will report to the other all adverse events (ahereinafter called "AE"), customer complaints, technical or quality-related incidents and/or issues, which come to its attention relating to the Product, including any that come to a Party's attention through publications in journals or other media. Each party shall report any serious adverse events relating to Product, within 48 hours of receipt, to the other. 4.3 Distributor shall be responsible for preparing and submitting medical device reports ("MDRs") Each of CZFS, CZFSAC to the FDA or other responsible national governmental authorities in the Territory. Company shall review and FCCB has timely filed evaluate all reports, registrations and statements, together with any amendments required Product complaints forwarded by Distributor. If Distributor believes that an MDR report needs to be made filed, Company shall fully investigate the complaint and shall provide all information necessary to Distributor for Distributor to file the MDR report. With respect to adverse events and the like occurring with respect theretothe Product outside the [*]CONFIDENTIAL TREATMENT REQUESTED 7 CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION CONFIDENTIAL DOCUMENT Territory, Company shall provide to Distributor all information relating to such complaints that may be or are subject to the FDA's reporting MDR requirements. Distributor shall evaluate this information and shall determine whether an MDR should be submitted. Company shall evaluate such events in relation to the standard operating procedures of Distributor's that will be adopted by Distributor and agreed upon by the parties. Company shall designate Distributor as agent to the FDA for these reporting purposes. 4.4 Within 15 days of the Effective Date of this Agreement, Company shall provide Distributor with copies of all documents relating to or constituting Company's 510(k) filing with the FDA. 4.5 Company agrees that it will not modify the Present Product or any other Product whose specifications have been agreed upon by the Parties without prior notification to and approval by Distributor (which approval shall not be unreasonably withheld) so that Distributor can ascertain whether Distributor will need to file any additional Rule 510(k) filings. 4.6 Company will register as the Product manufacturer with the FDA. Distributor will list Product with FDA as approved for marketing. 4.7 Each Party will maintain such records and procedures to ensure that any batch of Products can be effectively and completely recalled from the market in the event that such action is required. 4.8 If, for any reason, it shall become necessary to trace back or recall any particular lot of the Product, or to identify the customer or customers to whom units from such lot will have been delivered, each party shall co-operate fully with the other in doing so. In the event that either Party has reason to believe that one or more lots of the Product should be recalled or withdrawn from distribution in the Territory, such Party shall immediately notify the other Party in writing. To the extent permitted by the circumstances, the Parties will confer before initiating any recall, but the decision as to whether or not to initiate a recall of the Product and to notify regulatory authorities in the Territory shall be Distributor's alone. If the recall is required because of a modification or withdrawal of an approval from a competent regulatory authority or a failure of the Product to conform to its Specifications, Company shall promptly reimburse Distributor for the reasonable costs and expenses of such recall, and, at Distributor's option, Company shall replace the recalled Product free of additional charge, or credit or refund the Purchase Price of the recalled Product. If the recall is required because of a negligent act or omission of Distributor in handling, storage or distribution of the Product, then such recall shall be conducted by Distributor at its sole cost and expense and Distributor shall not be entitled to any such credits, replacements or refunds from Company. If such recall is required because of a joint act or omission of the Parties, Distributor shall conduct the recall, the Parties shall divide the cost of such a recall, and any replacement Product required by Distributor shall be provided by the Company to the Distributor at cost. 4.9 Each Party shall furthermore notify the other immediately of any information that it receives regarding any threatened or pending action by any Regulatory Authority which may affect the safety or efficacy claims of the Product within the Territory or the continued marketing of same. Upon receipt of any such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that it was required nothing contained herein shall be construed as restricting either Party's right to file since January 1, 2020 with [*]CONFIDENTIAL TREATMENT REQUESTED 8 CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION make a timely report of such matter to any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Regulatory Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, Territory or to the Knowledge of CZFS, investigation into the business take any further action that either Party deems appropriate or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in required by applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” law or betterregulation. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with 4.10 Distributor will provide a medical information service concerning the SEC Products to the health professionals and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged patients in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderTerritory. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.

Regulatory Matters. (ai) Each of CZFSSince January 1, CZFSAC 2019, SHBI and FCCB has timely its Subsidiaries have duly filed all reportswith the appropriate regulatory authorities in substantially correct form the monthly, registrations quarterly and statements, together with any amendments annual reports required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in filed under applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth such reports were in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC all material respects complete and NASDAQ all documents required by the Securities Act accurate and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in compliance in all material respects with the Securities requirements of applicable laws and regulations, and SHBI has previously delivered or made available to TCFC accurate and complete copies of all such reports. In connection with the most recent examination of SHBI and its Subsidiaries by the appropriate regulatory authorities, neither SHBI nor any of its Subsidiaries was required to correct or change any action, procedure or proceeding which SHBI believes in good faith has not been now corrected or changed, other than corrections or changes which, if not made, either individually or in the aggregate, would not have a Material Adverse Effect on SHBI. The most recent regulatory rating given to Shore United as to compliance with the Community Reinvestment Act and is at least “satisfactory.” To the Exchange ActKnowledge of SHBI, since the last regulatory examination of Shore United with respect to Community Reinvestment Act compliance, Shore United has not received any material complaints as to Community Reinvestment Act compliance. (cii) Neither CZFS, FCCB SHBI nor any of its Subsidiaries nor any of their respective properties is a party to or is subject to any Regulatory Order from order, decree, directive, agreement, memorandum of understanding or similar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor has SHBI or any of its Subsidiaries adopted any policies, procedures or board resolutions at the request or suggestion of, any Governmental Authority charged with the supervision Authority. SHBI and its Subsidiaries have paid all assessments made or regulation imposed by any Governmental Authority. (iii) Neither SHBI nor any of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB its Subsidiaries has been advised by, or has nor does it have any Knowledge of facts which could would reasonably be expected to give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderorder, decree, directive, agreement, memorandum of understanding, commitment letter, supervisory letter or similar submission or any request for the adoption of any policy, procedure or board resolution. (dA) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB No Governmental Authority has any Knowledge ofinitiated since January 1, nor has CZFS or FCCB been advised in writing of 2019 or has pending any reason proceeding, enforcement action or, to believe the Knowledge of SHBI, investigation or inquiry into the business, operations, policies, practices or disclosures of SHBI or any of its Subsidiaries (based on CZFS’s Home Mortgage Disclosure Act data for other than normal examinations conducted by a Governmental Authority in the year ended December 31ordinary course of the business of SHBI and its Subsidiaries), 2021or, filed with to the FDICKnowledge of SHBI, or otherwise) that threatened any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with of the CRAforegoing, and the regulations promulgated thereunder(B) there is no unresolved violation, criticism, comment or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective exception by any Governmental Authority with respect to any report or statement relating to any examinations or inspections of SHBI or any of its Subsidiaries, except in each case in subparagraphs (A) and (B), that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderdid not have a Material Adverse Effect on SHBI.

Regulatory Matters. (a) Each Schedule 3.10(a)(i) of CZFS, CZFSAC the Disclosure Schedule contains a correct and FCCB has timely filed complete list of all reports, registrations and statements, together with any amendments required to be made Approvals currently held by Seller with respect theretoto the Acquired Assets (the “Governmental Approvals”), which are all the Approvals that it was required are necessary for the ownership, operation, design, development, testing, marketing, sale or use of the Acquired Intellectual Property as and to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations the extent such activities are currently conducted by any Seller. Each Governmental Authority Approval is valid and in the regular course of the business of CZFS, CZFSAC and/or FCCBfull force and effect, no Governmental Authority has initiated Approval is subject to any proceedingLien, limitation, restriction, probation or other qualification, and there is no material default under any Governmental Approval or, to the Knowledge of CZFSSeller, investigation into any event, condition or occurrence that could reasonably be expected to form the business basis for the assertion of any such default. There is no Action pending or, to the Knowledge of Seller, threatened that would reasonably be expected to result in the termination, cancellation, modification, non-renewal, revocation, limitation, suspension, restriction or operations impairment of CZFSany Governmental Approval or the imposition of any fine, CZFSAC and/or FCCBpenalty or other sanctions for violation of any legal or regulatory requirements relating to any Governmental Approval nor, since January 1to the Knowledge of Seller, 2020is there any event, condition or occurrence that could reasonably be expected to form the basis therefor. FCCB Seller is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, compliance in all material respects with the Securities Act terms and conditions of each Governmental Approval. Seller has, and for the Exchange Actfour (4) years prior to the date hereof has had, all Approvals and Orders that are or were necessary in order to own and operate the Acquired Assets. (b) Except as set forth on Schedule 3.10(b)(ii) of the Disclosure Schedule, with respect to the Acquired Assets, Seller (i) is and has been for the five (5) years prior to the date hereof in compliance in all material respects with all Laws, including those administered by the United States Food and Drug Administration (“FDA”) and similar Governmental Authorities, applicable to the ownership, testing, development, manufacture, packaging, distribution, marketing, labeling, promotion, sale, import or export of the Acquired Intellectual Property and all applicable standards issued by a Governmental Authority and having the effect of Law that govern good manufacturing and clinical practice (collectively, “Applicable Laws”); (ii) has not received in the four (4) years prior to the date hereof any warning letter or other correspondence or written or, to the Knowledge of Seller, oral notice from the FDA or any other Governmental Authority alleging or asserting material noncompliance with any Applicable Laws or any Governmental Approvals; (iii) has not received written or, to the Knowledge of Seller, oral notice of any Action from any Governmental Authority or other Person alleging a violation by Seller of any Applicable Laws or Governmental Approvals and has no knowledge that any such Governmental Authority or Person is considering any such Action; (iv) has not received written or, to the Knowledge of Seller, oral notice that the FDA or any other Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Governmental Approvals and has no knowledge that any such Governmental Authority or Person is considering any such Action; (v) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Governmental Approvals and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete and correct on the date filed (or were corrected or supplemented by a subsequent submission); (vi) has not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any safety alert, post-sale warning, recalls or other notice or action relating to any Acquired Intellectual Property or any alleged product defect or violation with respect thereto and, to the Knowledge of Seller, no Person has initiated, conducted or intends to initiate any such notice or action; and (vii) has not, and none of its employees or Representatives has, made an untrue statement of material fact or fraudulent statement to the FDA or similar Governmental Authority or failed to disclose a material fact required to be disclosed to the FDA or similar Governmental Authority in connection with the Acquired Intellectual Property. (c) Neither CZFSSeller has made available, FCCB nor and prior to the Closing will deliver to Buyer, a true and correct copy of each of the following with respect to the last four (4) calendar years and the period from January 1, 2016 to the date hereof: (i) the numbers of all 510(k)s and premarket approval applications submitted to the FDA or similar applications submitted to other Governmental Authorities in connection with the Acquired Intellectual Property; (ii) all justifications by Seller or any of its Affiliates or any of their respective properties is predecessors for not filing a party 510(k) or similar filing for a change or modification to a marketed device in connection with the Acquired Intellectual Property; (iii) all premarket notification submissions (including 510(k)s) relating to the Acquired Intellectual Property and copies of all correspondence, including e-mails and records of conversations with the FDA, including all substantially equivalent or is subject not substantially equivalent letters received by Seller or its Affiliates or any of their respective predecessors in connection with the Acquired Intellectual Property; (iv) all correspondence, meeting notes or minutes, or related documents concerning material communications between the FDA and Seller or its Affiliates or any of their respective predecessors as they relate to 510(k) or similar submissions in connection with the Acquired Intellectual Property, including requests for additional information and responses thereto, and compliance matters; (v) all management review reports, management review actions, and management review follow activity relating to the Acquired Intellectual Property; (vi) all documents in response to FDA regulatory action(s) relating to the Acquired Intellectual Property, including all documents showing corrective actions undertaken by Seller or any of its Affiliates or any of their respective predecessors in response to FDA regulatory action(s); (vii) all FDA reports of inspection (Establishment Inspection Reports and Form FDA 483s) or analogous documents from other Governmental Authorities, including foreign Governmental Authorities, in connection with the Acquired Intellectual Property; (viii) all MedWatch forms received by Seller or its Affiliates or any of their respective predecessors for the Acquired Intellectual Property; (ix) all written reports of QSR audits of Seller or any of its Affiliates or any of their respective predecessors and their suppliers in Seller’s or its Affiliates’ possession or control in connection with the Acquired Intellectual Property; (x) all information and documents pertaining to the Acquired Intellectual Property required under FDA’s Regulations pertaining to complaints, medical device reports, and removals and corrections, including complaint files, corrective and preventive actions, adverse event files, all medical device reports and vigilance reports filed by Seller or any of its Affiliates or any of their respective predecessors, and correction and removal records and reports; (xi) for Acquired Intellectual Property, design history files, including design and development planning, design input and output, design review, design verification and validation, including software validation and risk analysis where appropriate, design transfer and design changes; and (xii) all documents and communications in Seller’s or its Affiliates’ possession (including written correspondence, telephone notes, memoranda, meeting notes or minutes reflecting oral communications, between Seller or any of its Affiliates or any of their respective predecessors and any Governmental Authority) that pertain to any Regulatory Order from recall of the Acquired Intellectual Property, including health hazard evaluations, recall strategies, public warnings, customer communications, effectiveness checks, status reports and termination letters. Seller has made available, and prior to the Closing Date will deliver, to Buyer a true and correct copy of all product labeling and advertising currently in use, including that posted on Seller’s or any Governmental Authority charged with the supervision of its Affiliates’ websites and in Seller’s or regulation any of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderits Affiliates’ user’s manuals. (d) With respect to the Acquired Assets, Seller has not solicited, received, paid or offered to pay any remuneration, directly or indirectly, overly or covertly, in cash or kind for the purpose of inducing any referral which violated any applicable anti-kickback Law, including the Federal Health Care Program Xxxx-Xxxxxxxx Xxxxxxx, 00 X.X.X. § 0000x-0x(x), or any applicable state anti-kickback Laws or foreign Laws with similar effect or purpose. (e) Neither CZFS Seller nor FCCB is a party any of its Affiliates has been required to file any notification or other report with or provide information to any agreement with any individual Governmental Authority or product safety standards group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS concerning actual or FCCB been advised in writing of potential defects or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued hazards with respect to anti-money laundering the Acquired Intellectual Property or any services performed by Seller or any of its Affiliates in connection therewith, and, to the U.S. Department Knowledge of Seller, there exist no grounds for the recall of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be Acquired Intellectual Property. The Acquired Intellectual Property contains and presents warnings in material compliance with the applicable requirements contained in any federal and state privacy under the Existing License Agreement. There are no statements, citations or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective decisions by any Governmental Authority and declaring the Acquired Intellectual Property defective or unsafe nor, to the knowledge of Seller, is there any fact or circumstance that meets could reasonably be expected to be a basis for such a statement, citation or decision. The Acquired Intellectual Property does not fail to meet any standards promulgated by any applicable Governmental Authority that have the requirements effect of Sections 352 and 326 and all other applicable provisions Law. Except as set forth on Schedule 3.10(b) of the USA PATRIOT Act and Disclosure Schedule, there have been no recalls ordered by any Governmental Authority with respect to the regulations thereunderAcquired Intellectual Property, nor, to the knowledge of Seller, is there any fact or circumstance that could reasonably be expected to be a basis for such a recall.

Regulatory Matters. (a) Each of CZFSParent’s and its Subsidiaries’ Product candidates are being and have been developed, CZFSAC and FCCB has timely filed all reportstested, registrations and statementsmanufactured, together with any amendments required to be made with respect theretopackaged, that it was required to file since January 1labeled, 2020 with any Governmental Authoritystored, imported, and has paid exported in compliance in all fees material respects with all applicable Laws, including, but not limited to Regulatory Laws, as well as any applicable Permits of Parent or any of its Subsidiaries, including but not limited to investigational new drug applications or their national or foreign equivalents. All such Parent Permits are in full force and assessments due effect, and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFSParent, investigation into the business no Governmental Entity has threatened to limit, suspend or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterrevoke any Parent Permit. (b) Other than Neither Parent nor any of its Subsidiaries has (i) received or been subject to any action, notice, citation, suspension, revocation, warning, administrative proceeding or investigation by a Governmental Entity or other Person that alleges or asserts that Parent or any of its Subsidiaries has violated any applicable Regulatory Laws or which requires or seeks any adjustment, modification or alteration in Parent’s or any of its Subsidiaries’ Product candidates or in the Parent’s or any of its Subsidiaries’ operations, activities, or services that has not been resolved, including any notice of inspectional observations, FDA warning letter or untitled letter or any similar notices or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, settlement agreement or other similar agreements or Orders mandating or prohibiting future or past activities. Neither Parent nor any of its Subsidiaries has settled, or agreed to settle, any actions brought by any Governmental Entity or any other Person for a violation of any applicable Regulatory Laws, nor is any such action pending resolution. As of the date hereof, (i) there are no restrictions imposed by any Governmental Entity upon the business, activities or services of Parent or any of its Subsidiaries that restrict Parent’s or any of its Subsidiaries’ business operations, (ii) Parent or any of its Subsidiaries and their respective Product candidates are not, and have not been, otherwise subject to any other enforcement actions taken by the FDA or any other Governmental Entity, and (iii) to the Knowledge of Parent, there are no facts that would reasonably be expected to give rise to such an event as set forth described in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has the immediately preceding clause (i) or (ii). (c) Parent and its Subsidiaries have timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such material reports, statements, documents, as registrations, filings, amendments, supplements and submissions required to be filed by them under applicable Regulatory Laws or the same may have been amended, complied, at the time filed with the SEC, terms of any Parent Permits. Each such filing complied in all material respects with applicable Regulatory Laws as of the Securities Act date of submission and was true, complete and correct as of the Exchange Act. (c) Neither CZFSdate of submission, FCCB nor and no deficiencies have been asserted in writing by any applicable Governmental Entity with respect to any such filings, submissions, reports or related information. Any material and legally necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings required to be submitted by Parent or any of their respective properties is a party its Subsidiaries have been submitted thereby to the applicable Governmental Entity or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderappropriate third party. (d) Neither CZFS nor FCCB is a party All nonclinical studies and clinical trials conducted or sponsored by or on behalf of Parent or any of its Subsidiaries have been, and if still pending are being, conducted in material compliance with applicable research protocols and all applicable Regulatory Laws and Parent Permits, including standards for conducting non-clinical laboratory studies, standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials (including for the protection of the rights and welfare of human subjects), and all applicable Laws restricting the use and disclosure of health information. No nonclinical study or clinical trial conducted or sponsored by or on behalf of Parent or its Subsidiaries with respect to any agreement with of Parent’s Product candidates has been terminated or suspended prior to completion due to safety or other non-business reasons, and, to the Knowledge of Parent, there are no facts that could give rise to such a determination. No Governmental Entity, institutional review board, ethics committee, independent monitoring committee, or institutional animal care and use committee has provided notice that it has initiated or, to the Knowledge of Parent, is threatening to initiate any individual action to place a hold order on, or group regarding CRA matters otherwise terminate, delay, suspend or modify any such ongoing nonclinical or clinical testing, and, to the Knowledge of Parent, there are no facts that would reasonably be expected to give rise to such action. (e) Neither Parent nor any of its Subsidiaries, nor, to the Knowledge of Parent, any officer, employee, or agent of Parent or any of its Subsidiaries (including Persons engaged by Parent for contract research, contract manufacturing, consulting, or other collaboration services), has made an untrue statement of a material fact or a fraudulent statement to the FDA or any other Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or such other Governmental Entity, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and neither CZFS Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Entity to invoke any similar policy. (f) Neither Parent nor FCCB its Subsidiaries, nor, to the Knowledge of Parent, any officer, employee, clinical investigator, or agent of Parent or its Subsidiaries has been debarred under 21 U.S.C. § 335a or any similar applicable Law or convicted of any crime or engaged in any conduct for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law. Neither Parent nor any of its Subsidiaries, nor, to the Knowledge ofof Parent, nor any officer, employee, clinical investigator, or agent of Parent or any of its Subsidiaries, has CZFS been excluded from participation in any federal health care program, or FCCB been advised in writing of any similar foreign program, or has been convicted of any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data crime or engaged in any conduct for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which such Person would cause CZFS or FCCB: (a) reasonably be expected to be deemed not to be excluded from participating in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation any federal health care program under Section 1128 of the federal Bank Secrecy ActSocial Security Act of 1935, as amended, and or any similar applicable Law or program. Neither Parent nor any of its implementing regulations (31 C.F.R. Chapter X)Subsidiaries is, and, to the USA PATRIOT ActKnowledge of Parent, and the regulations promulgated thereunderno officer, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Controlemployee, clinical investigator, or agent of Parent or any other applicable anti-money laundering statute, rule of its Subsidiaries is subject to an investigation or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective proceeding by any Governmental Authority Entity that would reasonably be expected to result in any such suspension, exclusion, or debarment, as applicable, and there are no facts, to the Knowledge of Parent, that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderwould reasonably be expected to give rise to such suspension, exclusion, or debarment.

Regulatory Matters. (ai) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, There are no Governmental Authority has initiated any proceedingpending, or to the Knowledge of CZFSSynovus, investigation threatened disputes or controversies (including with respect to capital requirements) as of the date hereof between Synovus or any of its Affiliates and any Governmental Authority (or any capital plan, supervisory agreement or order with any Governmental Authority entered into or binding upon Synovus or any of its Affiliates) that (A) would reasonably be expected to prevent Synovus from being able to perform its obligations under this Agreement or (B) would reasonably be expected to impair the business validity or operations consummation of CZFSthis Agreement or the transactions contemplated hereby. As of the date hereof, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (bx) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB neither Synovus nor any of their respective properties is a party to or is subject to its Affiliates has received any Regulatory Order indication from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority will oppose the transactions contemplated hereby and (y) to the Knowledge of Synovus no Governmental Authority required to provide a Synovus Required Approval will oppose or not grant such Synovus Required Approval or grant such Synovus Required Approval subject to a Synovus Burdensome Condition. As of the date hereof, neither Synovus nor any of its Affiliates is contemplating issuing subject to any cease-and-desist or requesting (other similar order or is considering the appropriateness of issuing enforcement action issued by, or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any written agreement, consent agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofmemorandum of understanding with, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and or is a party to any commitment letter or similar undertaking that meets prohibits the requirements consummation of Sections 352 and 326 and all other applicable provisions this Agreement or the transactions contemplated hereby. (ii) Synovus was rated at least satisfactory following its most recent CRA examination by the regulatory agency responsible for its supervision prior to the date hereof. Neither Synovus nor any of its Affiliates has received any written notice prior to the date hereof of any planned or threatened objection by any banking community group to the transactions contemplated hereby. As of the USA PATRIOT Act date hereof, both currently and after giving effect to the transactions contemplated hereby (on a pro forma basis): (A) Synovus is and will be at least “well-capitalized” (as that term or any replacement term therefor is defined from time to time in regulations thereunderapplicable to Synovus’s capital); and (B) Synovus meets all capital requirements, standards and ratios required by each state or federal bank regulator with jurisdiction over Synovus, including any such higher requirement, standard or ratio as applied to Synovus by state or federal bank regulator.

Regulatory Matters. (ai) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, There are no Governmental Authority has initiated any proceedingpending, or to the Knowledge of CZFSSeller, investigation threatened disputes or controversies (including with respect to capital requirements) as of the date hereof between Seller or any of its Affiliates and any Governmental Authority (or any capital plan, supervisory agreement or order with any Governmental Authority entered into or binding upon Seller or any of its Affiliates) that (A) would reasonably be expected to prevent Seller from being able to perform its obligations under this Agreement or (B) would reasonably be expected to impair the business validity or operations consummation of CZFSthis Agreement or the transactions contemplated hereby. As of the date hereof, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (bx) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB neither Seller nor any of their respective properties is a party to or is subject to its Affiliates has received any Regulatory Order indication from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority will oppose the transactions contemplated hereby and (y) neither Seller nor any of its Affiliates expects any Governmental Authority required to provide a Seller Required Approval to oppose or not grant such Seller Required Approval. Neither Seller nor any of its Affiliates is contemplating issuing subject to any cease-and-desist or requesting (other similar order or is considering the appropriateness of issuing enforcement action issued by, or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any written agreement, consent agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing memorandum of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDICunderstanding with, or otherwise) that is a party to any facts commitment letter or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance similar undertaking with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets prohibits the requirements consummation of Sections 352 and 326 and all other applicable provisions this Agreement or the transactions contemplated hereby. (ii) Seller was rated at least satisfactory following its most recent CRA examination by the regulatory agency responsible for its supervision prior to the date hereof. Neither Parent nor Seller has received any written notice prior to the date hereof of any planned or threatened objection by any banking community group to the transactions contemplated hereby. As of the USA PATRIOT Act date hereof: (A) Seller is and the will be at least “well-capitalized” (as that term or any replacement term therefor is defined from time to time in regulations thereunderapplicable to Seller’s capital); and (B) Seller meets all capital requirements, standards and ratios required by each state or federal bank regulator with jurisdiction over Seller, including any such higher requirement, standard or ratio as applied to Seller by state or federal bank regulator.

Regulatory Matters. (a) Each Subject to any obligations of CZFSSeller under the Transition Services Agreement, CZFSAC from and FCCB has timely filed after the Closing Date, Purchaser, at its cost, shall be solely responsible and liable for (i) taking all reportsactions, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid paying all fees and assessments due conducting all communication with the applicable Governmental Authority required by Law in respect of the Applicable Permits, including preparing and payable filing all reports (including adverse drug experience reports) with the applicable Governmental Authority (whether the Product is sold before or after transfer of the Registrations), (ii) taking all actions and conducting all communication with Third Parties with respect to Product sold pursuant to the Registrations (whether sold before or after transfer of the Registrations), including responding to all complaints in respect thereof, including complaints related to tampering or contamination, (iii) investigating all complaints and adverse drug experiences with respect to Product sold pursuant to the Registrations (whether sold before or after transfer of the Registrations), and (iv) carrying out any Phase IV post approval commitment (such as patient surveys) consistent with those described on Schedule 4.10(g) of the Seller Disclosure Schedule. At Purchaser's reasonable request, Seller shall cooperate, at its own expense, in connection therewith. Except for normal examinations conducted with the activities of Purchaser contemplated by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterthis Section 8.6(a). (b) Other than as set forth in CZFS Disclosure Schedule 4.11From and after the Closing Date, since January 1, 2020, CZFS has timely filed Seller shall promptly notify the Purchaser of complaints or reports received of an adverse drug experience with respect to the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActProduct. (c) Neither CZFSSubject to the terms in the Supply Agreement with respect to Product Manufactured by Seller, FCCB nor from and after the Closing Date, Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Product sold pursuant to such Registrations (whether sold before or after transfer of such Registrations), including recalls required by any of their respective properties is a party to or is subject to any Regulatory Order from any applicable Governmental Authority charged and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Product, and reasonable credits extended to customers in connection with the supervision recall, provided that such recall is not attributable to the negligence or regulation willful misconduct of financial institutions or issuers of securities or engaged Purchaser in conducting the Business. Seller promptly shall notify Purchaser in the insurance event that a recall of deposits (includingthe Product sold by Seller is necessary, without limitationand at Purchaser's reasonable request, the PADOBS and the FRB) or the supervision or regulation of itSeller shall cooperate, at its own expense, in connection with any such recall. Neither CZFS nor FCCB *** Certain information on this page has been advised by, or omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has any Knowledge of facts which could give rise been requested with respect to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderomitted portions. (d) Neither CZFS nor FCCB is a party To the extent not otherwise previously completed pursuant to any agreement with any individual Sections 3.2(a)(ii) or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of3.2(a)(iii), nor has CZFS or FCCB been advised in writing of or has any reason to believe Seller shall, within fifteen (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise15) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation days of the federal Bank Secrecy ActClosing Date, as amended, and its implementing regulations notify the FDA of the transfer of the Registrations to Purchaser in accordance with all applicable Laws. (31 C.F.R. Chapter Xe) To the extent not otherwise previously completed pursuant to Section 3.2(b)(iv), the USA PATRIOT ActPurchaser shall, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department within fifteen (15) days of the Treasury’s Office Closing Date, notify the FDA of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V its assumption of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other Registrations from Seller in accordance with applicable provisions of the USA PATRIOT Act and the regulations thereunderLaws.

Regulatory Matters. (a) Each of CZFSUntil the First Closing Date, CZFSAC and FCCB has timely filed Seller shall be solely responsible for (i) taking all reportsactions, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid paying all fees and assessments due conducting all communication with the appropriate Regulatory Authority required by Law in respect of Regulatory Approvals, including preparing and payable in connection therewith. Except filing all reports (including adverse drug experience reports, product deviation reports, annual reports, with the appropriate Regulatory Authority), (ii) submitting all applications for normal examinations conducted by any Governmental Authority in the regular course marketing authorizations of the business of CZFSnew drugs, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulationswhere such authorizations have not yet been granted, and FCCB has a Community Reinvestment Act rating variation of “satisfactory” or betterexisting authorizations, and (iii) investigating all complaints and adverse drug experiences with respect to Products sold pursuant to such Regulatory Approvals. (b) Other than as set forth in CZFS Disclosure Schedule 4.11Until the Second Closing Date, since January 1Seller shall be solely responsible for (i) taking all actions, 2020, CZFS has timely filed paying all fees and conducting all communication with the SEC and NASDAQ all documents appropriate Regulatory Authority required by Law in respect of Regulatory Approvals solely for the Securities Act PTB Indication, including preparing and the Exchange Act and such documentsfiling all reports (including adverse drug experience reports, as the same may have been amendedproduct deviation reports, compliedannual reports, at the time filed with the SECappropriate Regulatory Authority), in (ii) submitting all material respects applications for marketing authorizations of new drugs solely for the PTB Indication, where such authorizations have not yet been granted, and variation of existing authorizations, and (iii) investigating all complaints and adverse drug experiences with respect to Products sold pursuant to such Regulatory Approvals. The costs incurred by Seller for activities pursuant to this Section 8.5(b) shall constitute Development Costs of Seller subject to the Securities Act and the Exchange ActSeller Development Costs Cap. (c) Neither CZFSFrom and after the First Closing, FCCB nor any Buyer, at its cost shall be solely responsible for taking all actions and conducting all communication with third parties with respect to Products sold pursuant to such Regulatory Approvals (whether sold before or after transfer of their respective properties is a party such Regulatory Approval), including responding to or is subject all complaints in respect thereof, including complaints related to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (includingtampering, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bycontamination, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordercounterfeiting. (d) Neither CZFS nor FCCB Seller shall provide Buyer with such data as is a party reasonably necessary to any agreement comply with any individual or group regarding CRA matters Buyer’s reporting obligations for Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)), Average Manufacturers Price (as defined at 42 U.S.C. § 1396r-8(k)(1)) and neither CZFS nor FCCB has any Knowledge ofAverage Sales Price (as defined at 42 U.S.C. § 1395w-3(a)(c)) for such period as is reasonably necessary, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be exceed one (1) year after the First Closing Date. (e) From and after the First Closing Date, Buyer promptly (and in satisfactory compliance with any event within the CRA, and the regulations promulgated thereunder, time periods required by Law) shall notify Seller within three (3) Business Days if Buyer receives a complaint or to be assigned a rating for CRA purposes by Bank Regulators report of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued an adverse drug experience with respect to antiProducts. In addition, Buyer shall cooperate with Seller’s reasonable requests and use Commercially Reasonable Efforts to assist Seller in connection with the investigation of and response to any complaint or adverse drug experience related to Products sold by Buyer. (f) From and after the First Closing Date, Buyer shall be responsible for (i) conducting all voluntary and mandatory recalls of units of Products sold pursuant to such Regulatory Approvals (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Regulatory Authority and recalls of units of Products sold by Seller deemed necessary by Seller in its reasonable discretion, (ii) conducting all communications and submitting all required reports to any Regulatory Authority concerning the recalls and (iii) notifying customers and consumers about the recalls. Seller promptly shall notify Buyer in the event that a recall of Products sold by Seller is necessary. Seller shall be responsible for all costs associated with recalls of Products sold prior to First Closing Date; provided, however, if Buyer and Seller sell Product from the same lot, then Buyer and Seller shall be responsible for the cost of recalls of Products sold from such lot in proportion to their pro-money laundering by rata sales of Products from such lot. (g) Seller and Buyer each agree to promptly prepare and file whatever filings, requests or applications are required or deemed advisable to be filed with any Regulatory Authority in connection with the U.S. Department Transactions and transfer and assumption of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) Regulatory Approvals and to be deemed not cooperate with one another as reasonably necessary to be in material compliance with accomplish the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderforegoing.

Regulatory Matters. Except as set forth in Section 3.15 of the Disclosure Schedule: (a) Each As to each product subject to the FDCA or similar Law in any foreign jurisdiction that is developed, manufactured, tested, distributed and/or marketed by the Business (a “Medical Device”), each such Medical Device is being developed, manufactured, tested, distributed and/or marketed in compliance with all applicable requirements under the FDCA and similar Laws, including those relating to investigational use, premarket clearance or marketing approval to market a Medical Device, good manufacturing practices, labeling, advertising, record keeping, filing of CZFSreports and security, CZFSAC and FCCB in compliance with the Advanced Medical Technology Association Code of Ethics on Interactions with Healthcare Professionals and the American Medical Association’s guidelines on gifts to physicians, except for failures that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. None of Guidant or its Affiliates has timely filed all reportsreceived any notice or other communication from the FDA or any other Governmental Authority (i) contesting the premarket clearance or approval of, registrations the uses of or the labeling and statementspromotion of any products of the Business, together with or (ii) otherwise alleging any amendments required violation applicable to be made with respect theretoany Medical Device of any Law, in the case of (i) and (ii), that it was required individually or in the aggregate have not had and would reasonably be expected to file have a Material Adverse Effect. (b) No Medical Device is under consideration by senior management of Guidant or its Affiliates for recall, withdrawal, suspension, seizure or discontinuance, or has been recalled, withdrawn, suspended, seized or discontinued (other than for commercial or other business reasons) by, Guidant, a Transferred Subsidiary or an Asset Seller in the United States or outside the United States (whether voluntarily or otherwise), in each case since January 1, 2020 2002. No proceedings in the United States or outside of the United States of which Guidant has Knowledge (whether completed or pending) seeking the recall, withdrawal, suspension, seizure or discontinuance of any Medical Device are pending against Guidant, a Transferred Subsidiary or an Asset Seller or any licensee of any Medical Device that individually or in the aggregate have had or would reasonably be expected to have a Material Adverse Effect. (c) As to each Medical Device for which a premarket approval application, premarket notification, investigational device exemption or similar state or foreign regulatory application has been approved, the Business and the Transferred Subsidiaries are in compliance with any Governmental Authority21 U.S.C. §§ 360 and 360e or 21 C.F.R. Parts 812 or 814, respectively, and has paid all fees similar Laws and assessments due all terms and payable conditions of such licenses or applications, except for any such failure or failures to be in connection therewith. Except for normal examinations conducted by any Governmental Authority compliance that individually or in the regular course aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. In addition, with respect to the Business and the Transferred Subsidiaries, Guidant and its Affiliates are in substantial compliance with all applicable registration and listing requirements set forth in 21 U.S.C. § 360 and 21 C.F.R. Part 807 and all similar Laws, except for any such failures to be in compliance that individually or in the aggregate have not had and would not reasonably be expected to have a Material Adverse Effect. (d) No article of any Medical Device is (i) adulterated within the business meaning of CZFS21 U.S.C. § 351 (or similar Law), CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding(ii) misbranded within the meaning of 21 U.S.C. § 352 (or similar Law), or (iii) a product that is in violation of 21 U.S.C. § 360 or § 360e (or similar Law), except for failures to be in compliance with the foregoing that would not reasonably be expected to have a Material Adverse Effect. (e) With respect to the Business and the Transferred Subsidiaries, none of Guidant or its Affiliates, nor, to the Knowledge of CZFSGuidant, investigation into any officer, employee or agent of Guidant or any of its Affiliates, has made an untrue statement of a material fact or fraudulent statement to the business FDA or operations any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, could reasonably be expected to provide a basis for the FDA or any other Governmental Authority to invoke its policy respecting “Fraud, Untrue Statements of CZFSMaterial Facts, CZFSAC and/or FCCBBribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) With respect to the Business and the Transferred Subsidiaries, none of Guidant or its Affiliates, nor, to the Knowledge of Guidant, any officer, employee or agent of Guidant or any of its Affiliates, has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. With respect to the Business and the Transferred Subsidiaries, none of Guidant or its Affiliates, nor, to the Knowledge of Guidant, any officer, employee or agent of Guidant or its Affiliates has been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended (the “Social Security Act”) or any similar Law. (g) With respect to the Business and the Transferred Subsidiaries, since January 1, 2020. FCCB 2002, none of Guidant or its Affiliates has received any written notice that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to withdraw its approval or request the recall of any Medical Device, (ii) commenced, or threatened to initiate, any action to enjoin production of any Medical Device, or (iii) commenced, or threatened to initiate, any action to enjoin the production of any medical device produced at any facility where any Medical Device is “well-capitalized” as defined manufactured, tested or packaged, except for any such action that individually or in applicable laws the aggregate have not had and regulations, and FCCB has would not reasonably be expected to have a Community Reinvestment Act rating of “satisfactory” or betterMaterial Adverse Effect. (bh) Other than as set forth in CZFS Disclosure Schedule 4.11To the Knowledge of Guidant, since January 1there are no facts, 2020circumstances or conditions that would reasonably be expected to form the basis for any investigation, CZFS has timely filed with suit, claim, action or proceeding against or affecting the SEC Business relating to or arising under (i) the FDCA, or (ii) the Social Security Act or regulations of the Office of the Inspector General of the Department of Health and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SECHuman Services, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to each case individually or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures aggregate that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderhad or would reasonably be expected to have a Material Adverse Effect.

Regulatory Matters. (a) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted All Products which have been developed by any Governmental Authority in the regular course Geron as of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or date hereof (the “Geron Products”) that are subject to the Knowledge jurisdiction of CZFSthe FDA have been developed in compliance in all material respects with all applicable requirements, investigation into if any, under the business or operations of CZFSFood and Drug and Cosmetic Act (“FDCA”), CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in the Public Health Service Act and their applicable laws and implementing regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11To the Knowledge of Geron, since January 1all preclinical studies and clinical trials and all preclinical research, 2020, CZFS has timely filed clinical development and manufacturing activities conducted by or on behalf of Geron with respect to the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may Technology have been amended, complied, at the time filed with the SEC, conducted in all material respects with the Securities Act and the Exchange Actapplicable Legal Requirements, including those relating to protection of human subjects. (c) Neither CZFSAll manufacturing operations conducted by Geron with respect to Geron Products being used in human clinical trials have been conducted in accordance, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged in all material respects, with the supervision or regulation of financial institutions or issuers of securities or engaged in FDA’s cGMP regulations. To the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise Geron, all manufacturing operations conducted for the benefit of Geron with respect to an advisory notice bythe Geron Products being used in human clinical trials have been conducted in accordance, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering in all material respects, with the appropriateness of issuing or requesting) any Regulatory OrderFDA’s cGMP regulations. (d) Neither CZFS nor FCCB is a party to As of the date of this Agreement, Geron has not received any agreement with written notice that the FDA or any individual other Regulatory Authority has initiated, or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised threatened in writing to initiate, any action to suspend any clinical trial relating to the Technology. (e) Neither Geron nor, to the Knowledge of Geron, any Representatives acting for Geron, has committed any act, made any statement in writing or has failed to make any reason statement in writing that would reasonably be expected to believe (based on CZFS’s Home Mortgage Disclosure Act data provide a valid basis for the year ended December 31FDA to invoke its policy with respect to “Fraud, 2021Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg 46191 (September 10, 1991) and any amendments thereto. (f) As of the date hereof, there are no Proceedings pending with respect to a violation by Geron of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other Legal Requirement promulgated by a Governmental Body with respect to the Geron Products. (g) To the Knowledge of Geron, there have been no reports of any serious adverse events affecting any patients participating in the GRNOPC1 clinical trials for spinal cord injury that, prior to the Closing, have been determined to be product-related. (h) The Regulatory Filings identified in Schedule 1.1(h) include all material documents filed with the FDIC, FDA by or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) on behalf of Geron relating to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation Technology of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering type contemplated by the U.S. Department definition of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderRegulatory Filings.

Regulatory Matters. (a) Each of CZFSOn the Closing Date, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required Seller shall transfer the Regulatory Documentation to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterBuyer. (b) Other than as set forth Subject to Section 7.10(a), from and after the Closing, Buyer, at its cost, shall be solely responsible and liable for (i) taking all actions, paying all fees and conducting all communication with the appropriate Governmental or Regulatory Authority required by Law in CZFS Disclosure Schedule 4.11respect of the Regulatory Approvals or the Regulatory Documentation, since January including preparing and filing all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority, (ii) taking all actions and conducting all communication with third parties in respect of the Product (whether sold before or after Closing), including responding to (A) complaints in respect thereof, including complaints related to tampering or contamination, and (B) all medical information requests, and (iii) investigating all complaints and adverse drug experiences in respect of the Product (whether sold before or after Closing). From the Closing Date and for three (3) years thereafter, Buyer shall (1, 2020, CZFS has timely ) provide a copy of any annual report with respect to the Product and filed with the SEC FDA by Buyer and NASDAQ all documents required (2) provide Seller with a copy of any 15-day reportable adverse drug experience reports that are identified with a lot number for Product sold by Seller before the Securities Act Closing Date within two (2) Business Days after Buyer’s submission thereof to the FDA. From and after the Exchange Act Closing Date, Seller shall provide Buyer with prompt written notice (within two Business Days) in the that event Seller becomes aware of any complaints, medical information requests, investigations or adverse drug experiences in respect of the Product and such documents, as the same may have been amended, complied, at the time filed shall cooperate with the SEC, Buyer in all material respects with the Securities Act investigating and the Exchange Actresponding thereto. (c) Neither CZFSSeller shall prepare the annual report in respect of the Product due April 1, FCCB nor any of their respective properties is a party 2009 (the “Filing Deadline”) and shall use commercially reasonably efforts to or is subject file such report prior to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged Closing Date, but in all events shall file such report no later than the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAFiling Deadline, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation shall provide Buyer with copies of the federal Bank Secrecy Actsame; provided, as amendedhowever, that if the Closing occurs prior to the Filing Deadline and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that Seller has not been deemed ineffective by any Governmental Authority and that meets filed the requirements of Sections 352 and 326 and all other applicable provisions of report prior to Closing, Seller shall provide such report to Buyer at the USA PATRIOT Act and the regulations thereunderClosing.

Regulatory Matters. (a) Each Parent and the Parent Subsidiaries hold all material licenses, permits, franchises, variances, registrations, exemptions, orders and other governmental authorizations, consents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all authorizations under the FDCA, the PHSA and the regulations of CZFSthe FDA promulgated thereunder, CZFSAC and FCCB has timely filed all reportsany other Government Authority that regulates the quality, registrations and statementsidentity, together with strength, purity, safety, efficacy or manufacturing of Parent’s current or under-development products (any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental such Government Authority, and has paid all fees and assessments due and payable in connection therewith. Except a “Parent Regulatory Agency”) required for normal examinations conducted by any Governmental Authority in the regular course lawful operation of the business businesses of CZFSParent and the Parent Subsidiaries (the “Parent Permits”). All such Parent Permits are valid and in full force and effect. None of such Parent Permits will be terminated or impaired or become terminable, CZFSAC and/or FCCBin whole or in part, no Governmental Authority has initiated as a result of the transactions contemplated by this Agreement. Parent and the Parent Subsidiaries are the sole and exclusive owner of the Parent Permits and the associated filings and applications with the FDA, including any proceedingbiologics license application, new drug application, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to Parent and the Knowledge Parent Subsidiaries (collectively, the “Parent Regulatory Filings”) and hold all right, title and interest in and to all Parent Regulatory Filings free and clear of CZFSany encumbrance. Parent and the Parent Subsidiaries have not granted any third party any right or license to use, investigation into access or reference any of the business Parent Regulatory Filings, including, without limitation, any of the know-how contained in any of the Parent Regulatory Filings or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterrights (including any regulatory exclusivities) associated with each such Parent Regulatory Filing. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since Since January 1, 20202008, CZFS there has timely filed not occurred any breach or violation of, default (with the SEC and NASDAQ all documents required by the Securities Act or without notice or lapse of time or both) under or event giving rise to any right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Parent Permit. Parent and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, Parent Subsidiaries are in compliance in all material respects with the Securities Act terms of all Parent Permits, and no event has occurred and no facts or circumstances exist that, to the Exchange Actknowledge of Parent, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Parent Permit. (c) Neither CZFSSince January 1, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including2008, without limitationall material applications, the PADOBS submissions, information and the FRB) data utilized by Parent or the supervision or regulation of it. Neither CZFS nor FCCB has been advised byParent Subsidiaries as the basis for, or has any Knowledge submitted by or, to the knowledge of facts which could give rise to an advisory notice byParent, on behalf of Parent or the Parent Subsidiaries in connection with, any Governmental Authority that and all requests for Parent Permits when submitted to the FDA or other Parent Regulatory Agency, were accurate and complete in all material respects as of the date of submission, and any updates, changes, corrections or modifications to such Governmental Authority is contemplating issuing applications, submissions, information and data required under Applicable Law have been submitted to the FDA or requesting (or is considering the appropriateness of issuing or requesting) any other Parent Regulatory OrderAgency. (d) Neither CZFS Since January 1, 2008, neither Parent nor FCCB is any of the Parent Subsidiaries has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data basis for the year ended December 31, 2021, filed with the FDIC, FDA or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) other Parent Regulatory Agency to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and invoke its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued policy with respect to anti-money laundering “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or similar policies under Applicable Law. Neither Parent’s nor any of the Parent Subsidiaries’ agents or subcontractors has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the U.S. Department of the Treasury’s Office of Foreign Assets Control, FDA or any other applicable anti-money laundering statuteGovernment Authority, rule and there are no proceedings pending or regulationthreatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority. (e) Neither Parent nor any of the Parent Subsidiaries nor, to the knowledge of Parent, any director, officer, agent, employee or other Person associated with or acting on behalf of Parent or any of the Parent Subsidiaries has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the FCPA or any similar Applicable Law; or (civ) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. (f) Since January 1, 2008, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any product of Parent or product candidate of Parent. (g) Parent and its Subsidiaries are in compliance in all material respects with all Applicable Laws and any other letters, notices or guidance issued by the FDA or any Government Authority which regulate the sale of pharmaceutical products or biological, or device products in any jurisdiction. There are no pending or, to the knowledge of Parent, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against Parent or its Subsidiaries. Since January 1, 2008 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Applicable Law relating to Parent or any Parent Subsidiary or the products or product candidates of Parent or any Parent Subsidiary or any subpoenas or investigative demands or other written inquiries that would reasonably be deemed not interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to be any product or any product candidate of Parent or any Parent Subsidiary. (h) The manufacture of the products of Parent or any Parent Subsidiary is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA. (i) Parent and its Subsidiaries are and have been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. There have been no Serious Adverse Events or Serious Injuries associated with the applicable requirements contained use (including in clinical trials) of the products or product candidates of Parent or any federal Parent Subsidiary that have not been reported to the FDA in accordance with Applicable Law. (j) To the knowledge of Parent, all studies, tests, and state privacy or data security laws preclinical and regulationsclinical research being conducted by Parent and Parent Subsidiaries, and to the knowledge of Parent, on behalf of Parent and Parent Subsidiaries, are being, and at all times have been, conducted incompliance in all material respects with all Applicable Laws, including, without limitationas applicable, good laboratory practice regulations set forth in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder21 C.F.R. Part 58, good clinical practices, as well as defined or recognized by the provisions of FDA, including the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000ICH Tripartite Guideline for Good Clinical Practice, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any other Government Authority. No clinical trial conducted by Parent or any Parent Subsidiary or, to the knowledge of Parent, on behalf of Parent or any Parent Subsidiary has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the knowledge of Parent, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial. (k) Neither Parent nor any Parent Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of Parent or any Parent Subsidiary, nor, to the knowledge of Parent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of Parent or any Parent Subsidiary is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing Federal Health Care Programs. (l) Neither Parent nor any Parent Subsidiary nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of Parent or any Parent Subsidiary, nor, to the knowledge of the Parent, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of Parent or any Parent Subsidiary: (i) has been debarred, excluded or suspended from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act; (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the knowledge of Parent, is the target or subject of any current investigation by a Government Authority relating to any Federal Health Care Program related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program. (m) To the knowledge of Parent, there are no pending or threatened filings against Parent or any Parent Subsidiary of an action relating to Parent or any Parent Subsidiary under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (n) To the knowledge of Parent, neither Parent nor any Parent Subsidiary is under investigation by any Government Authority for a violation of HIPAA or the regulations thereundercontained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local laws. Neither Parent nor any Parent Subsidiaries are “covered entities” as that term is defined in HIPAA. Parent and the Parent Subsidiaries have been in compliance in all material respects with federal and state data breach laws.

Regulatory Matters. (a) Each Seller, or an Affiliate of CZFSSeller, CZFSAC possesses all Purchased Regulatory Approvals. The Purchased Regulatory Approvals are valid and FCCB are in full force and effect. No proceeding is pending or, to Seller’s Knowledge, threatened in writing regarding the validity or revocation of any Purchased Regulatory Approval. As of the Execution Date, neither Seller nor its Affiliates has timely filed all reports, registrations and statements, together with received any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by written communication from any Governmental Authority threatening to withdraw or suspend any Purchased Regulatory Approval. Neither Seller nor any of its Affiliates is in the regular course material violation of the business terms of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterPurchased Regulatory Approval. (b) Other than During the two years prior to the Execution Date, there has not been any product recall or market withdrawal or replacement conducted by or on behalf of Seller concerning the Product or, to Seller’s Knowledge, the Authorized Generic Product or, to Seller’s Knowledge, any product recall, market withdrawal or replacement conducted by or on behalf of any Third Party as set forth a result of any alleged defect in CZFS Disclosure Schedule 4.11the Product or the Authorized Generic Product. Seller has made available to Buyer copies of material complaints and notices of alleged defect or adverse reaction with respect to the Product or the Authorized Generic Product that have been received in writing by Seller and its Affiliates during the two years prior to the Execution Date. In the two years prior to the Execution Date, since January 1all material documents, 2020declarations, CZFS has listings, registrations, notices, reports or submissions, including Adverse Event or other safety reports, required to be filed by Seller and any Affiliate of Seller with respect to the Product or Authorized Generic Product have been so filed on a timely filed basis, were in material compliance with applicable Laws when filed, and were complete and accurate in all material respects when filed. (c) During the SEC two years prior to the Execution Date, the Product distributed and NASDAQ all documents required by sold in the Securities Act Territory and the Exchange Act and such documents, as the same may have Authorized Generic Product has been amended, complied, at the time filed with the SEC, Manufactured in compliance in all material respects with applicable Law, including cGMP, and applicable Regulatory Approvals. None of Seller, any Affiliate of Seller or, to Seller’s Knowledge, any Third Party engaged by Seller in connection with the Securities Act Manufacture of the Product or the Authorized Generic Product for distribution and sale in the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party Territory has received in the two years prior to the Execution Date or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bywarning letter, or has any Knowledge notice of facts which could give rise to an advisory notice bydeficiency, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by any facility Manufacturing the U.S. Department of Product or the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be Authorized Generic Product for distribution and sale in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderTerritory.

Regulatory Matters. For a given POC Program, during the applicable POC Term: (i) The POC Lead Regulatory Party shall be primarily responsible for regulatory matters with respect to the Collaboration Products in connection with the performance of the applicable POC Program. The POC Lead Regulatory Party shall ensure that all directions from any Regulatory Authority, ethics committees or institutional review boards with jurisdiction over any Clinical Studies are followed. Further, the POC Lead Regulatory Party shall ensure that all necessary approvals, licenses, registrations or authorizations (including any IND or CTA) from any Regulatory Authority, ethics committees or institutional review boards with jurisdiction over the Clinical Study are obtained prior to initiating performance of such Clinical Study. (ii) Subject to POC Committee oversight on the overall regulatory strategy for the Collaboration Products, including oversight of the initial IND or CTA filings for a given Collaboration Product, the POC Lead Regulatory Party shall have primary responsibility with respect to submitting Regulatory Filings for the applicable Collaboration Products (other than DMFs) and all communications with, and submissions to, Regulatory Authorities in connection with such Collaboration Products, with the other Party’s support and input, which support shall be provided by the other Party upon reasonable request by the POC Lead Regulatory Party [***]. The POC Lead Regulatory Party shall also be responsible for all routine maintenance of all INDs or CTAs (other than DMFs) for the applicable Collaboration Products. Without limiting the foregoing, Moderna shall provide such information and assistance as Merck may reasonably request in connection with the completion of and submission of, and maintenance of, Regulatory Filings (other than DMFs), including INDs and CTAs, and responses to inquiries from Regulatory Authorities, provided that (A) to the extent Moderna CMC Information is [***] or (B) in the event disclosure of Moderna CMC Information [***], Merck will notify Moderna [***], provided further that in the event that the Parties are unable to agree [***], then such matter shall be referred to the Executive Officers (or their designees), and if the Executive Officers (or their designees) are unable to agree on such course of action within such time frame, then [***]. In the event additional Moderna CMC Information not currently contained within regulatory documents [***], the Parties shall mutually agree [***]. Moderna will be reasonable [***]. (iii) If Moderna is the POC Lead Regulatory Party for any Clinical Studies involving Keytruda, Moderna shall act as the sponsor of such Clinical Study under its existing IND or CTA for the applicable Collaboration Product and have a Right of Reference to the IND or CTA of Keytruda; provided, however, that in no event shall Moderna file an additional IND or CTA for any Clinical Study involving Keytruda unless required by Regulatory Authorities to do so. If a Regulatory Authority requests an additional IND or CTA for a Clinical Study involving Keytruda, the Parties shall meet and mutually agree on an approach to address such requirement. Merck shall provide reasonable support and input to enable Moderna to prepare and file an amendment solely to the extent required. (iv) The POC Lead Regulatory Party shall, subject to applicable Law, (1) allow subject matter experts from the other Party to [***], (2) through the POC Committee, allow the other Party a reasonable opportunity to review and comment upon all material Regulatory Filings (other than DMFs or portions of such Regulatory Filings containing Moderna CMC Information) to Regulatory Authorities for the applicable Collaboration Products, and the POC Lead Regulatory Party [***], (3) [***], and (4) promptly provide to individuals in the other Party’s regulatory group copies of any material correspondence or other documents received from Regulatory Authorities with respect to the applicable Collaboration Products. In all cases, Merck shall have the right (but not the obligation) to participate in any discussions with a Regulatory Authority regarding matters related to Keytruda or any Merck Agent. In all cases, Moderna shall have the right (but not the obligation) to participate in any discussions with a Regulatory Authority regarding matters related to [***]. (v) If Moderna is the POC Lead Regulatory Party for any Clinical Studies involving Keytruda, Merck shall provide to Moderna, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference for Keytruda. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to a Moderna Agent, Merck Agent or Keytruda, as applicable. Merck shall authorize the FDA and other applicable Regulatory Authorities to cross-reference the applicable Merck INDs and CTAs for Keytruda to provide data access to Moderna sufficient to support conduct of any Clinical Study sponsored by Moderna involving Keytruda. If Merck’s IND or CTA is not available in a given country, Merck will file its CMC data with the applicable Regulatory Authority for such country, referencing Moderna’s IND or CTA as appropriate (however, Moderna shall have no right to directly access the CMC data for Keytruda). (vi) If Moderna is the POC Lead Regulatory Party for any Clinical Studies involving Keytruda, Moderna shall (a) Each of CZFS, CZFSAC track and FCCB has timely filed collect financial disclosure information from all reports, registrations “clinical investigators” involved in any Clinical Studies involving Keytruda and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, (b) prepare and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in submit the regular course certification or disclosure of the business same in accordance with all applicable Law, including Part 54 of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents. Prior to the Knowledge initiation of CZFSclinical activities under any Clinical Study sponsored by Moderna involving Keytruda, investigation into the business Parties shall determine, in writing, whether Moderna shall track and collect separate certification or operations disclosure forms for each of CZFSMerck and Moderna or one (1) “combined” certification or disclosure form for both Merck and Moderna. For purposes of this Section 3.4(k)(vi), CZFSAC and/or FCCB, since January 1, 2020. FCCB is the term “well-capitalizedclinical investigators” as defined shall have the meaning set forth in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating Part 54.2(d) of “satisfactory” or betterTitle 21 of the United States Code of Federal Regulations. (bvii) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject With respect to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged annual reporting period in the insurance of deposits (includingwhich Moderna is not an entity that is required to make a Transparency Report under applicable Law, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCBModerna will: (a) notify Merck, in writing, within [***] days after the commencement of such reporting period that Moderna is not so required; and (b) during such reporting period Moderna will track and provide to Merck data regarding “indirect” payments or other transfers of value by Moderna to such health care professionals to the extent such payments or other transfers of value were required, instructed, directed or otherwise caused by Merck pursuant to this Agreement in the format requested by Merck and provided on a basis to be deemed not agreed upon by both Parties. Moderna represents and warrants that any data provided by Moderna to Merck pursuant to part (b) above will be complete and accurate to the best of Moderna’s knowledge. With respect to any such annual reporting period in satisfactory compliance which Moderna is required to make a Transparency Report under applicable Law, Moderna will provide to Merck, in writing, Moderna’s point of contact for purposes of receiving information from Merck pursuant to this Section 3.4(k)(vii), along with such contact’s full name, email address, and telephone number. Moderna may update such contact from time to time by notifying Merck in writing pursuant to Section 15.15. Where applicable, Merck will provide to such Moderna contact all information regarding [***] provided for use in a Clinical Study required for such reporting. In the CRAevent that the [***] provided pursuant to this Section 3.4(k)(vii) changes, Merck shall notify Moderna of such revised value and the effective date thereof. For purposes of this Section 3.4(k)(vii), “Transparency Report” means a transparency report in connection with reporting payments and other transfers of value made to health care professionals, including investigators, steering committee members, data monitoring committee members, and consultants in connection with a Clinical Study in accordance with reporting requirements under applicable Law, including the Physician Payment Sunshine Act and state gift laws, and the regulations promulgated thereunderEuropean Federation of Pharmaceutical Industries and Associations Disclosure Code, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the TreasuryParty’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderpolicies.

Regulatory Matters. (a) Each Acquired Corporation is, and since the Applicable Date has been, in compliance in all material respects with all Health Care Laws, in each case as applicable to the operation of CZFSits business. Since the Applicable Date, CZFSAC and FCCB no Acquired Corporation, nor, to the knowledge of the Company, any third parties that have performed or are performing any development, collaboration, manufacturing, testing, quality control, batch release, distribution or shipment activities on behalf of an Acquired Corporation or with respect to a Product Candidate, including any CMO, CRO, Clinical Trial site or investigator, while acting in such capacity (each, a “Collaboration Partner”) (i) has timely filed all reportsbeen subject to any enforcement, registrations and statements, together regulatory or administrative proceedings alleging non-compliance with any amendments required Health Care Laws; (ii) has received written notice threatening any such enforcement, regulatory or administrative proceeding; or (iii) has been issued a FDA Form 483, warning letter, notice of violation of Health Care Laws, or similar correspondence from any Governmental Body, except where any such issuance or violation would not be reasonably expected, individually or in the aggregate, to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or material to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” Acquired Corporations taken as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterwhole. (b) Other than Since the Applicable Date, the Acquired Corporations have held all Regulatory Permits required for their business as set forth then-conducted, and each Regulatory Permit required for their business as currently conducted is valid and in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC in full force and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, effect. The Acquired Corporations are in compliance in all material respects with the Securities Act terms and requirements of such Regulatory Permits. Since the Exchange ActApplicable Date, no deficiencies have been asserted in writing by any applicable Governmental Body with respect to any Regulatory Permits of the Acquired Corporations. None of the Acquired Corporations has received written notice that any material Regulatory Permit will not or is likely not to be issued. (c) Neither CZFSTo the knowledge of the Company, FCCB nor all preclinical and clinical investigations, studies, or trials (“Clinical Trials”) sponsored or conducted by or on behalf of the Acquired Corporations have been and are being conducted in material compliance with applicable Health Care Laws and Data Privacy Laws. No Acquired Corporation, nor, to the knowledge of the Company, any of their respective properties is a party Collaboration Partners or other Persons acting directly on their behalf, has received any written notice or other correspondence from the FDA or any other Governmental Body performing functions similar to or is subject those performed by the FDA with respect to any Regulatory Order from any Governmental Authority charged with the supervision ongoing Clinical Trial requiring or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (includingrecommending a clinical hold, without limitation, the PADOBS and the FRB) or the supervision termination, suspension or regulation material modification of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderClinical Trials. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, The Acquired Corporations have filed with the FDICFDA or any other Governmental Body performing functions similar to those performed by the FDA all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports, and any required updates, corrections or modifications to each of the foregoing. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Health Care Laws when filed, and no deficiencies have been asserted in writing by any applicable Governmental Body with respect thereto. (e) To the knowledge of the Company, no Acquired Corporation, nor, to the knowledge of the Company, any Collaboration Partner or other Person acting directly on its behalf has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or for any Governmental Body to invoke a similar policy that may be applicable in another jurisdiction to an Acquired Corporation. No Acquired Corporation is the subject of any pending or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. No Acquired Corporation nor, to the knowledge of the Company, any Collaboration Partner, officer, employee, agent or other Person acting on behalf of any Acquired Corporation has been debarred or disqualified, excluded from participation in federal healthcare programs or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. § 335a or any similar Legal Requirement, (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement, or otherwise(C) disqualification pursuant to 21 CFR Part 312.70 or any similar Legal Requirement. (f) Since the Applicable Date, the Acquired Corporations have not received any written notice from a Governmental Body that any facts of their products are misbranded as defined in 21 U.S.C. § 352 or circumstances existadulterated as defined in 21 U.S.C. § 351, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAas amended, and the rules and regulations promulgated thereunder, or as defined in comparable Legal Requirements in any jurisdiction. (g) Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the Acquired Corporations and, to the knowledge of the Company, their Collaboration Partners, or other Persons acting directly on their behalf have prepared, submitted and implemented timely responses and, as applicable, any corrective action plans required to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) prepared and submitted in response to be deemed to be operating in material violation all internal or third-party audits, inspections, investigations or examinations of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), Product Candidates or the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the TreasuryAcquired Corporation’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderbusiness.

Regulatory Matters. Between the date of this Agreement and the Closing Date: (a) Each As soon as practicable after the date hereof, but in no event more than 30 days after the date hereof, Buyer shall prepare all Applications and make all filings for all necessary permits, consents, approvals, waivers and authorizations of CZFSall Regulatory Authorities identified on Schedule 6.01(c) or as are otherwise necessary or advisable to consummate the Contemplated Transactions. Buyer shall thereafter use its best efforts to obtain, CZFSAC as promptly as practicable, all such necessary permits, consents, approvals, waivers and FCCB has timely filed authorizations of all reportsRegulatory Authorities identified on Schedule 6.01(c) or as are otherwise necessary or advisable to consummate the Contemplated Transactions. Buyer shall, registrations subject to applicable law, (i) permit counsel for Seller to review in advance, and statementsconsider in good faith the views of Seller in connection with, together any proposed written communication to any Regulatory Authority in connection with the transactions contemplated hereby, and (ii) provide counsel for Seller with copies of all filings made by Buyer, and all material correspondence between such party (and Buyer’s advisors) with any amendments required Regulatory Authority and any other information supplied by Buyer and Buyer’s Affiliates to be made a Regulatory Authority or received from such a Regulatory Authority in connection with respect the transactions contemplated hereby. Buyer will use its best efforts to keep Seller apprised of all applications and developments related thereto, that it was required and, where reasonably practicable under the circumstances, give Seller reasonable advance notice of, and, at the sole option of Buyer, invite Seller (and give due consideration in good faith to file since January 1any reasonable request of Seller) to participate in, 2020 any meetings or discussions held with any Governmental Regulatory Authority, and has paid all fees and assessments due and payable in connection therewith; provided that such participation is not restricted by such Regulatory Authority. Except for normal examinations conducted as may be required by law, Buyer further covenants and agrees not to extend any Governmental waiting period associated with any Consent or enter into any agreement with any Regulatory Authority in not to consummate the regular course Contemplated Transactions, except, subject to applicable law, with the prior written consent of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterSeller. (b) Other than Seller shall, and shall cause Target to, prepare all Applications and the making of all filings for, and shall use its best efforts to obtain, as set forth promptly as practicable, all necessary permits, consents, approvals, waivers and authorizations of all Regulatory Authorities identified on Schedule 6.02(c) or as are otherwise necessary or advisable to consummate the Contemplated Transactions. Seller shall, and shall cause Target to, subject to applicable law, (i) permit counsel for Buyer to review in CZFS Disclosure Schedule 4.11advance, since January 1and consider in good faith the views of Buyer in connection with, 2020, CZFS has timely filed any proposed written communication to any Regulatory Authority in connection with the SEC transactions contemplated hereby, and NASDAQ (ii) provide counsel for Buyer with copies of all documents required filings made by Seller, and all material correspondence between such party (and Seller’s advisors) with any Regulatory Authority and any other information supplied by Seller and Seller’s Affiliates to a Regulatory Authority or received from such a Regulatory Authority in connection with the Securities Act transactions contemplated hereby. Seller will use its best efforts to keep Buyer apprised of all applications and developments related thereto, and, where reasonably practicable under the Exchange Act and such documentscircumstances, as the same may have been amendedgive Buyer reasonable advance notice of, compliedand, at the time filed sole option of Seller, invite Buyer (and give due consideration in good faith to any reasonable request of Buyer) to participate in, any meetings or discussions held with the SEC, in all material respects with the Securities Act and the Exchange Actany Regulatory Authority; provided that such participation is not restricted by such Regulatory Authority. (c) Neither CZFSSeller shall, FCCB nor and shall cause Target to, promptly furnish Buyer with copies of written communications to, or received by any of their respective properties is a party to or is subject to them from, any Regulatory Order from any Governmental Authority charged with in respect of the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderContemplated Transactions. (d) Neither CZFS nor FCCB is a The Parties shall cooperate with each other in the foregoing matters and shall furnish all information concerning themselves as may be necessary or advisable in connection with any Application or filing made by or on behalf of such party to any agreement or with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised Regulatory Authority in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed connection with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAContemplated Transactions, and the regulations promulgated thereunderin each such case, or to such information shall be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating accurate and complete in all material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X)respects. In connection therewith, the USA PATRIOT ActParties shall use their reasonable good faith efforts to provide each other certificates, certifications from accountants and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to documents as may be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderreasonably requested.

Regulatory Matters. (a) Each In the event that laws, regulations or rules of CZFSthe Brazilian government or governmental agencies, CZFSAC including the Brazilian Central Bank, prohibit Itau from (i) offering non-bank products inside its branches (and FCCB has timely filed pursuant to the applicable rules the Co-Branded Service is considered a non-bank product) or, (ii) carrying-out any in-branch marketing activities as provided for in this MOA (collectively a "Regulatory Event"), then Itau will be released from all reportsobligations prohibited as a result of such Regulatory Event ("Prohibited Obligations") after the date of the Regulatory Event ("Regulatory Event Date"). In the event a Regulatory Event results in all of or a material portion of Itau's in-branch marketing obligations under Sections 2(a) and (b) of this Exhibit A being deemed Prohibited Obligations, registrations and statements, together with any amendments required the Target Revenue Percentage shall be deemed to be made with respect theretozero for the remaining term of the SMA. In consideration for such release, that it was required Itau shall pay AOLB the sum of (A) the product of (i) a Reference Payment for the Anniversary Year in which such Regulatory Event occurs calculated using the Revenue Elements generated and incurred during the period from the last Anniversary Date to file since January 1, 2020 with any Governmental Authoritythe Regulatory Event Date occurred, and has paid all fees (ii) a fraction, the numerator of which is the number of days from the last Anniversary Date to the Regulatory Event Date, and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority the denominator of which is 365, (B) if, in the regular course absence of the business release in the foregoing paragraph, the failure to perform a Prohibited Obligation(s) would result in any Marketing Payment, any such Marketing Payment that would be due for the Quarter in which the Regulatory Event Date occurs calculated based on Itau's performance of CZFSthe Prohibited Obligation(s) during the period beginning on the first day of the Quarter and ending on the Regulatory Event Date, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or and (C) the maximum Marketing Payment related to the Knowledge Prohibited Obligation(s) that could be due for those Quarters commencing after the Regulatory Event Date. In addition, if the Target Revenue Percentage is deemed to be zero due to such Regulatory Event, then AOLB shall have the option, after such Regulatory Event, to release Itau from all of CZFSItau `s marketing obligations hereunder, investigation into including without limitation, those obligations set forth in Sections 1(a), 1(d), 2, 3 and 5. In consideration for such release, Itau shall pay to AOLB the business or operations maximum Marketing Payments that could be due for those Quarters commencing after the exercise of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersuch option. (b) Other than as set forth If any Brazilian judicial authority of competent jurisdiction determines that all Promoters and/or Supervisors deployed in CZFS Disclosure Schedule 4.11Itau bank branches are deemed banking employees for purposes of determining the wages and benefits of Promoters and/or Supervisors, since January 1but not that such Promoters or Supervisors must be hired by or otherwise become employees of Itau, 2020then, CZFS has timely filed within twenty days of AOLB's receipt of written notice of such judicial determination from Itau, AOLB shall notify Itau in writing that it will either (i) bear one-half of the additional incremental expenses of the Promoters and Supervisors that are a direct result of such determination (and Itau shall bear the other one-half of such amount), or (ii) decrease the number of Promoters and Supervisors required under this MOA (such decreased Promoters and Supervisors, the "Decreased Promoters") such that the expenses associated with the SEC and NASDAQ all documents required by Decreased Promoters is equal to one half of the Securities Act and the Exchange Act and such documents, as the same may additional incremental expenses that would have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actincurred by Itau as a direct result of such judicial determination without such a reduction. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to An "Employee Labor Event" shall be deemed to have occurred if any Brazilian judicial authority of competent jurisdiction determines that all Promoters and/or Supervisors deployed in Itau bank branches must be operating in material violation hired by or otherwise become employees of Itau. At any time during the one-hundred twenty (120) day period after the occurrence of the federal Bank Secrecy ActEmployee Labor Event, as amendedItau may elect to accept such determination, in which case it shall promptly so notify AOLB in writing, and its implementing regulations AOLB within twenty (31 C.F.R. Chapter X20) days after such notice shall notify Itau in writing that (i) it will bear one-half of the additional incremental expenses of the Promoters and Supervisors that are a direct result of such determination (and Itau shall bear the other one-half of such amount), or (ii) that it will decrease the USA PATRIOT Actnumber of Promoters and Supervisors required under this MOA (such decreased Promoters and Supervisors, and the regulations promulgated thereunder, any order issued "Decreased Promoters") such that the expenses associated with respect the Decreased Promoters is equal to anti-money laundering by the U.S. Department one half of the Treasury’s Office additional incremental expenses that would have been incurred by Itau as a direct result of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, such Employee Labor Event without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersuch a reduction.

Regulatory Matters. (a) Each of CZFS, CZFSAC Seller is the sole and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course exclusive owner of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined Product Regulatory Approvals and all Product Regulatory Approvals are in applicable laws full force and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettereffect. (b) Other than as set forth Seller is conducting the Business in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed material compliance with the SEC Product Regulatory Approvals and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actapplicable Laws. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged Seller has filed with the supervision FDA all material applications, exemptions, requests, notices, information, supplemental applications and annual or regulation other reports, including adverse experience reports, product deviation reports and annual reports with respect to each NDA and IND, related to Seller’s Development, manufacture, testing, study, distribution or sale of financial institutions or issuers of securities or engaged in Products. To the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise Seller, all applications, exemptions, requests, notices, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Regulatory Approval of the FDA or other Regulatory Authorities relating to an advisory notice bythe Products, when submitted to the FDA or other Regulatory Authorities were true, complete and correct in all material respects as of the date of submission and any Governmental Authority that necessary or required material updates, changes, corrections or modifications to such Governmental Authority is contemplating issuing applications, exemptions, requests, notices, submissions, information, claims, reports or requesting (or is considering the appropriateness of issuing or requesting) any statistics have been submitted to FDA and other Regulatory OrderAuthorities. (d) Neither CZFS nor FCCB is a party All pre-clinical and clinical trials conducted by or on behalf of the Seller with regard to any agreement the Products were and are being conducted in material compliance with any individual experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable Laws promulgated by the FDA relating thereto, including without limitation the FDCA and its applicable implementing regulations. No IND filed by or group on behalf of Seller with the FDA regarding CRA matters the Products has been terminated or suspended by the FDA, and neither CZFS the FDA nor FCCB any applicable foreign Regulatory Authority has commenced, or, to the Knowledge of Seller, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Seller involving the Products. (e) Seller has made available to Buyer all material information in its possession or control concerning the safety, efficacy, side effects or toxicity of the Products (in animals or humans), associated with or derived from any pre-clinical or clinical use, studies, investigations or tests of the Product. Since January 1, 2005, no Product has been recalled, suspended, discontinued, or withdrawn from the market, and no Product is currently involved in any ongoing, and to the Knowledge ofof Seller, nor threatened or potential recall, discontinuance, withdrawal, or suspension from the market within the Territory. Seller has CZFS no Knowledge of any serious adverse events from the use of the Products that are not disclosed in the package inserts, adverse experience reports or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data periodic safety update for the year ended December 31Products. (f) As of the Execution Date, 2021Seller has not received notice that Seller, filed with its Products or any of the FDICPurchased Assets or the ownership, or otherwise) that any facts or circumstances existmanufacturing, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAoperation, and the regulations promulgated thereunderstorage, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating Development, Commercialization, warehousing, packaging, labeling, handling, testing, and/or marketing thereof is in material violation of any Regulatory Approval or applicable Law and such violation has not been remedied, except for such violations that would not reasonably be expected to have a Material Adverse Effect. To the federal Bank Secrecy ActKnowledge of Seller, as amendedthere are no facts or circumstances existing which would lead to any suspension, and its implementing regulations loss of or material modification to any Regulatory Approval or refusal by a Regulatory Authority to renew or accept for filing any Regulatory Approval on terms not substantially less advantageous, in the aggregate, to Seller than the terms of those Regulatory Approvals currently in force. There are no outstanding orders, injunctions or decrees of any Regulatory Authority that apply to Seller that restrict the ownership, disposition or use of Products by Seller. (31 C.F.R. Chapter X)g) To the Knowledge of Seller, the USA PATRIOT Act(i) there are no investigations, and the regulations promulgated thereunderaudits, any order issued actions or other proceedings pending with respect to anti-money laundering a violation by the U.S. Department Seller of the Treasury’s Office of Foreign Assets Control, FDCA or any other applicable anti-money laundering statute, rule or regulation; or (c) Law that would reasonably be expected to be deemed not to be result in material compliance with the applicable requirements contained in any federal administrative, criminal or material civil liability and state privacy (ii) there are no facts or data security laws and regulationscircumstances existing that would reasonably be expected to serve as a basis for such an investigation, includingaudit, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all action or other applicable provisions of the USA PATRIOT Act and the regulations thereunderproceeding.

Regulatory Matters. For a given POC Program, during the applicable POC Term: (i) The POC Lead Regulatory Party shall be primarily responsible for regulatory matters with respect to the Collaboration Products in connection with the performance of the applicable POC Program. The POC Lead Regulatory Party shall ensure that all directions from any Regulatory Authority, ethics committees or institutional review boards with jurisdiction over any Clinical Studies are followed. Further, the POC Lead Regulatory Party shall ensure that all necessary approvals, licenses, registrations or authorizations (including any IND or CTA) from any Regulatory Authority, ethics committees or institutional review boards with jurisdiction over the Clinical Study are obtained prior to initiating performance of such Clinical Study. (ii) Subject to POC Committee oversight on the overall regulatory strategy for the Collaboration Products, including oversight of the initial IND or CTA filings for a given Collaboration Product, the POC Lead Regulatory Party shall have primary responsibility with respect to submitting Regulatory Filings for the applicable Collaboration Products (other than DMFs) and all communications with, and submissions to, Regulatory Authorities in connection with such Collaboration Products, with the other Party’s support and input, which support shall be provided by the other Party upon reasonable request by the POC Lead Regulatory Party [***]. The POC Lead Regulatory Party shall also be responsible for all routine maintenance of all INDs or CTAs (other than DMFs) for the applicable Collaboration Products. Without limiting the foregoing, Moderna shall provide such information and assistance as Merck may reasonably request in connection with the completion of and submission of, and maintenance of, Regulatory Filings (other than DMFs), including INDs and CTAs, and responses to inquiries from Regulatory Authorities, provided that (A) to the extent Moderna CMC Information is [***] or (B) in the event disclosure of Moderna CMC Information [***], Merck will notify Moderna [***], provided further that in the event that the Parties are unable to agree [***], then such matter shall be referred to the Executive Officers (or their designees), and if the Executive Officers (or their designees) are unable to agree on such course of action within such time frame, then [***]. In the event additional Moderna CMC Information not currently contained within regulatory documents [***], the Parties shall mutually agree [***]. Moderna will be reasonable [***]. (iii) If Moderna is the POC Lead Regulatory Party for any Clinical Studies involving Keytruda, Moderna shall act as the sponsor of such Clinical Study under its existing IND or CTA for the applicable Collaboration Product and have a Right of Reference to the IND or CTA of Keytruda; provided, however, that in no event shall Moderna file an additional IND or CTA for any Clinical Study involving Keytruda unless required by Regulatory Authorities to do so. If a Regulatory Authority requests an additional IND or CTA for a Clinical Study involving Keytruda, the Parties shall meet and mutually agree on an approach to address such requirement. Merck shall provide reasonable support and input to enable Moderna to prepare and file an amendment solely to the extent required. (iv) The POC Lead Regulatory Party shall, subject to applicable Law, (1) allow subject matter experts from the other Party to [***], (2) through the POC Committee, allow the other Party a reasonable opportunity to review and comment upon all material Regulatory Filings (other than DMFs or portions of such Regulatory Filings containing Moderna CMC Information) to Regulatory Authorities for the applicable Collaboration Products, and the POC Lead Regulatory Party [***], (3) [***], and (4) promptly provide to individuals in the other Party’s regulatory group copies of any material correspondence or other documents received from Regulatory Authorities with respect to the applicable Collaboration Products. In all cases, Merck shall have the right (but not the obligation) to participate in any discussions with a Regulatory Authority regarding matters related to Keytruda or any Merck Agent. In all cases, Moderna shall have the right (but not the obligation) to participate in any discussions with a Regulatory Authority regarding matters related to [***]. (v) If Moderna is the POC Lead Regulatory Party for any Clinical Studies involving Keytruda, Merck shall provide to Moderna, as necessary, a cross-reference letter or similar communication to the applicable Regulatory Authority to effectuate the Right of Reference for Keytruda. Notwithstanding anything to the contrary in this Agreement, neither Party shall have any right to access the other Party’s CMC data with respect to a Moderna Agent, Merck Agent or Keytruda, as applicable. Merck shall authorize the FDA and other applicable Regulatory Authorities to cross-reference the applicable Merck INDs and CTAs for Keytruda to provide data access to Moderna sufficient to support conduct of any Clinical Study sponsored by Moderna involving Keytruda. If Merck’s IND or CTA is not available in a given country, Merck will file its CMC data with the applicable Regulatory Authority for such country, referencing Moderna’s IND or CTA as appropriate (however, Moderna shall have no right to directly access the CMC data for Keytruda). (vi) If Moderna is the POC Lead Regulatory Party for any Clinical Studies involving Keytruda, Moderna shall (a) Each of CZFS, CZFSAC track and FCCB has timely filed collect financial disclosure information from all reports, registrations “clinical investigators” involved in any Clinical Studies involving Keytruda and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, (b) prepare and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in submit the regular course certification or disclosure of the business same in accordance with all applicable Law, including Part 54 of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or Title 21 of the United States Code of Federal Regulations (Financial Disclosure by Clinical Investigators) and related FDA Guidance Documents. Prior to the Knowledge initiation of CZFSclinical activities under any Clinical Study sponsored by Moderna involving Keytruda, investigation into the business Parties shall determine, in writing, whether Moderna shall track and collect separate certification or operations disclosure forms for each of CZFSMerck and Moderna or one (1) “combined” certification or disclosure form for both Merck and Moderna. For purposes of this Section 3.4(k)(vi), CZFSAC and/or FCCB, since January 1, 2020. FCCB is the term “well-capitalizedclinical investigators” as defined shall have the meaning set forth in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating Part 54.2(d) of “satisfactory” or betterTitle 21 of the United States Code of Federal Regulations. (bvii) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject With respect to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged annual reporting period in the insurance of deposits (includingwhich Moderna is not an entity that is required to make a Transparency Report under applicable Law, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCBModerna will: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitationnotify Merck, in Title V writing, within [***] days after the commencement of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program such reporting period that contains adequate and appropriate customer identification verification procedures that has Moderna is not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.so required; and

Regulatory Matters. (a) Each of CZFSExcept as would not, CZFSAC and FCCB has timely filed all reportsindividually or in the aggregate, registrations and statements, together with any amendments required reasonably be expected to be made with respect theretomaterial to the Company or any Acquired Corporation, that it was required to file each Acquired Corporation is, and since January 1, 2020 2021 has been, in material compliance with all Healthcare Laws. No Acquired Corporation nor any Governmental Authorityof its respective owners, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted officers, directors, or managing employees who provide services relating to the business of such Acquired Corporation: (i) is a party to any individual or corporate integrity agreements, monitoring agreements, deferred prosecution agreements, consent decrees, settlement orders, or similar agreements imposed by any Governmental Authority in the regular course Body relating to any noncompliance with Healthcare Laws; (ii) has been assessed a civil money penalty under Section 1128A of the business Social Security Act or any regulations promulgated thereunder or any other fine or penalty by any other Governmental Body; or (iii) has been charged with, convicted of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated or entered a plea of guilty or nolo contendere to any proceeding, criminal or civil offense relating to the Knowledge delivery of CZFS, investigation into the business any item or operations of CZFS, CZFSAC and/or FCCBservice under a Governmental Health Program. No Acquired Corporation is or, since January 1, 2020. FCCB is “well2021, has been, subject to any ongoing enforcement, regulatory or administrative proceedings against such Acquired Corporation alleging non-capitalized” as defined in applicable laws and regulationscompliance with any Healthcare Laws, and FCCB no Acquired Corporation has received any notification or communication from the FDA or any other Governmental Body performing functions similar to those performed by the FDA, DOJ, and OCR (each a Community Reinvestment Act rating “Healthcare Regulatory Authority”) alleging any material non-compliance with any Healthcare Law, including any (i) FDA Form 483 or warning letter or (ii) “Notice of “satisfactoryAdverse Findings” from the FDA or bettersimilar notice from any other Healthcare Regulatory Authority. (b) Other than The Acquired Corporations hold all material Regulatory Permits required for their business as set forth currently conducted, and each such Regulatory Permit is valid and in CZFS Disclosure Schedule 4.11, full force and effect and will be available for use by the respective Acquired Corporation or its applicable Subsidiary immediately after the Closing. The Acquired Corporations are and since January 1, 20202021, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in compliance in all material respects with the Securities Act terms and requirements of such Regulatory Permits. Since January 1, 2021, no deficiencies, revocations or impairments have been received or asserted in writing, or to the Exchange Actknowledge of the Company, otherwise, by any Governmental Body with respect to any Regulatory Permits of the Acquired Corporations. The Company has made available to Parent accurate and complete copies of all such Regulatory Permits, which are set forth on Schedule 2.13(b). (c) Neither CZFSExcept as set forth in Schedule 2.13(c), FCCB nor all preclinical and clinical investigations sponsored by the Acquired Corporations have been and are being conducted in material compliance with applicable Healthcare Laws, including Good Clinical Practices requirements and federal and state laws, rules, regulations and binding guidance restricting the use and disclosure of individually identifiable health information. No Acquired Corporation has received any written, or to the knowledge of their respective properties is a party to the Company, oral notice or is subject to any Regulatory Order other communication from any Governmental Authority charged Body with respect to any ongoing clinical or pre-clinical studies or tests requiring or recommending the supervision termination, suspension or regulation material modification of financial institutions such studies or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordertests. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, The Acquired Corporations have filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, FDA and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statuteHealthcare Regulatory Authorities all required material filings, rule declarations, listings, registrations, reports or regulation; submissions, including but not limited to adverse event reports. All such filings, declarations, listings, registrations, reports or (c) to be deemed not to be submissions were in material compliance with applicable Healthcare Laws when filed, and no deficiencies have been asserted in writing, or, to the knowledge of the Company, orally, by any applicable requirements contained Governmental Body with respect to any such filings, declarations, listings, registrations, reports or submissions. (e) Since January 1, 2021, the Acquired Corporations have not (i) voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued any recall, field corrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any product (a “Recall”) or been required to do so, or (ii) received any written notice from a Healthcare Regulatory Authority regarding (A) any Recall of any product, or (B) a change in the marketing status or classification, or a material change in the labeling of any product. (f) To the knowledge of the Company, no Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statement to any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to any Governmental Body or (iii) committed any other act, made any statement or failed to make any statement, that (in any federal such case) establishes a reasonable basis for the FDA to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and state privacy Illegal Gratuities Final Policy, or data security laws and regulations, including, without limitation, in Title V for any other Governmental Body to invoke any similar policy. As of the Xxxxx-Xxxxx-Xxxxxx Act date of 1999 this Agreement, neither the Company nor, to the Company’s knowledge, any entity acting on the Company’s behalf with respect to any preclinical or clinical investigation sponsored by the Company, is subject to any pending or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and regulations promulgated thereunderIllegal Gratuities Final Policy. No Acquired Corporation nor, as well as to the provisions knowledge of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000Company, Xxxxxxx Xany officers, Xxxxxxxx D. Furthermoreemployees, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions agents or clinical investigators of the USA PATRIOT Act Company or any entity or individual acting on the Company’s behalf with respect to any preclinical or clinical investigation sponsored by the Company has been suspended, debarred, excluded from participation in a Governmental Health Program or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment or suspension under 21 U.S.C. § 335a or any similar Legal Requirement or (B) exclusion or suspension under 42 U.S.C. § 1320a-7 or any similar Legal Requirement. (g) The Acquired Corporations maintain, and since January 1, 2021, have maintained, a compliance program designed to address compliance with Healthcare Laws. Except as would not, individually or in the regulations thereunderaggregate, reasonably be expected to be material to the Company or any Acquired Corporation, there are no outstanding compliance-related complaints or reports, ongoing internal compliance investigations, or compliance-related corrective actions.

Regulatory Matters. (a) Each Subject to any restrictions in the Assigned License Agreements to the extent of CZFSInformation under the applicable Assigned License Agreement, CZFSAC promptly following the Effective Date, Shire shall provide to Mirum copies of all Regulatory Materials in Shire’s or its Affiliates’ possession within the Shire Know-How, Pfizer Know-How, Sanofi Know-How and FCCB has timely filed Satiogen Know-How and the Parties will take all reports, registrations such actions (including execution of such documents) as reasonably necessary to transfer rights and statements, together with any amendments required to be made responsibilities with respect theretoto all filings within such Regulatory Materials to Mirum in accordance with a mutually agreed timeline, that it was required including transfer of investigational new drug applications for the Existing Trials to file since January 1Mirum as soon as possible after the Effective Date. Except in connection with the Existing Trials conducted by or on behalf of Shire or its Affiliates prior to the transition to Mirum as set forth in Section 5.3(b), 2020 with any Governmental AuthorityMirum shall have sole responsibility and control, at its sole cost and expense, for seeking, preparing, obtaining, and has paid maintaining all fees filings with Regulatory Authorities to Develop and assessments due manufacture the Licensed Products within the Territory and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority all Regulatory Approvals to Commercialize the Licensed Products within the Territory, and conducting all communications related thereto with the Regulatory Authorities in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterTerritory. (b) Other than The Parties shall work in good faith to transition the conduct of the clinical trials listed on Exhibit 5.3(b) (“Existing Trials”) from Shire (or its Affiliate) to Mirum as set forth soon as practicable after the Effective Date. Until such transition is complete, (a) Mirum hereby grants to Shire a license under any Regulatory Materials, Patents and Information Controlled by Mirum to the extent necessary for Shire (or its Affiliate) to conduct the Existing Trials and (b) Mirum shall reimburse Shire within […***…] of invoicing for all reasonable internal and out-of-pocket costs incurred by Shire or its Affiliates for the conduct of the Existing Trial from the Effective Date until such transition is complete. Mirum shall use Commercially Reasonable Efforts to effectuate the transition of the Existing Trials to Mirum including, if needed, using Commercially Reasonable Efforts to enter into agreements with Third Parties previously working with Shire or its Affiliates in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed connection with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActExisting Trials. (c) Neither CZFSMirum shall notify Shire promptly following its determination that any event, FCCB nor any of their respective properties is a party to incident, or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged circumstance has occurred that would result in the insurance of deposits (includingneed for a recall, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bymarket suspension, or has market withdrawal of Compounds or Licensed Products in the Territory. Mirum shall have the right to make the final determination whether to voluntarily implement any Knowledge such recall, market suspension, or market withdrawal in the Territory. Mirum shall conduct any recall, market suspension, or market withdrawal of facts which could give rise to an advisory notice byCompounds or Licensed Products in the Territory in compliance with applicable Law. Mirum shall have the sole responsibility and control over all recalls, any Governmental Authority that such Governmental Authority is contemplating issuing market suspensions, or requesting (market withdrawals of Compounds or is considering Licensed Products in the appropriateness of issuing or requesting) any Regulatory OrderTerritory at its own expense. (d) Neither CZFS nor FCCB is a party Any information provided by Mirum to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason Shire pursuant to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwisethis Section 5.3(c) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to shall be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, Mirum’s Confidential Information and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect subject to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder“Article 7.

Regulatory Matters. (a) Each of CZFS, CZFSAC NBT and FCCB NBT Bank has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, Authority and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC NBT and/or FCCBNBT Bank, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFSNBT, investigation into the business or operations of CZFS, CZFSAC NBT and/or FCCBNBT Bank, since January 1, 2020. FCCB There is no unresolved violation or matter requiring attention by any Governmental Authority with respect to any report or statement relating to any examinations of NBT Bank. Each of NBT and NBT Bank is “well-capitalized” as defined in applicable laws and regulations, and FCCB NBT Bank has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS NBT Disclosure Schedule 4.11, since January 1, 2020, CZFS NBT has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFSNBT, FCCB NBT Bank nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or institutions engaged in the insurance of deposits (including, without limitation, the PADOBS OCC and the FRB) or the supervision or regulation of it. Neither CZFS NBT nor FCCB NBT Bank has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing Without limiting the generality of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter XSection 8.10(b), the USA PATRIOT Act, and parties acknowledge that this Section 4.11 is subject to the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department limitations of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (cSection 8.10(b) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderhereof.

Regulatory Matters. (a) Each Meadow and each of CZFSits Subsidiaries are, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 have been, in compliance in all respects with all applicable Laws, including the FDCA and any other similar Laws administered or promulgated by the FDA or other comparable Governmental AuthorityEntity, except for any noncompliance which would not have a Meadow Material Adverse Effect. Without limiting the foregoing, all Meadow Products have been manufactured, packaged, labeled, tested, stored, shipped, handled, warehoused, and has paid distributed in accordance with all fees applicable Laws and assessments due Meadow Permits (as defined below), commensurate with the Meadow Products’ stage of development, and payable in connection therewithare not and have not been adulterated, misbranded, or prohibited from introduction into interstate commerce under applicable Law. Except for normal examinations conducted To Meadow’s Knowledge, as of the date hereof, no investigation, inspection, claim, suit, proceeding, audit or other action by any Governmental Authority in the regular course Entity is pending or threatened against Meadow or any of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterits Subsidiaries. (b) Other than There is no agreement, judgment, injunction, order or decree binding upon Meadow or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any material business practice of Meadow or any of its Subsidiaries, any acquisition of material property by Meadow or any of its Subsidiaries or the conduct of any material portion of the business by Meadow or any of its Subsidiaries as set forth in CZFS Disclosure Schedule 4.11currently conducted, (ii) is reasonably likely to have a material adverse effect on Xxxxxx’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Contemplated Transactions. (c) Meadow and its Subsidiaries have at all times since January 1, 20202020 held and have operated in compliance with all Governmental Authorizations that are necessary for the conduct of the business of Meadow and its Subsidiaries as currently being conducted (the “Meadow Permits”), CZFS has except where such failures to hold or remain so in compliance would not have a Meadow Material Adverse Effect. All such Meadow Permits are valid and are in full force and effect, and assuming the notices, filings or other Consents listed on Section 4.16(c) of the Meadow Disclosure Schedule have been made or obtained, will continue to be so upon consummation of the Contemplated Transactions, except as would not have a Meadow Material Adverse Effect. (d) Section 4.16(d) of the Meadow Disclosure Schedule identifies each Meadow Permit. Meadow and its Subsidiaries hold all right, title and interest in and to all the Meadow Permits free and clear of any Lien. All fees and charges with respect to such Meadow Permits, as of the date hereof, have been paid in full and all filing, reporting and maintenance obligations have been completely and timely filed satisfied, except as would not have a Meadow Material Adverse Effect. Meadow and each of its Subsidiaries are in material compliance with the SEC terms of the Meadow Permits. To Meadow’s Knowledge, as of the date hereof no Legal Proceeding is pending or threatened, which seeks to revoke, limit, suspend, or materially modify any Meadow Permit. (e) To Meadow’s Knowledge, as of the date hereof there are no proceedings pending or threatened with respect to an alleged material violation by Meadow or any of its Subsidiaries of the FDCA or any other similar Law administered or promulgated by any comparable Governmental Entity. As of the date hereof, neither Meadow, any of its Subsidiaries nor to Meadow’s Knowledge, any Person providing services to Meadow or any of its Subsidiaries with respect to Meadow’s product candidates zandelisib, voruciclib or ME-344 and NASDAQ currently contemplated uses (the “Meadow Products”) has received any written notice, including any warning letter, untitled letter, cyber letter, FDA Form-483, Establishment Inspection Report, written notice of other adverse finding, notice of integrity review, notice of investigation, request for corrective or remedial action, or notice of deficiency or violation, or similar written communication from the FDA or any other Governmental Entity alleging that Meadow or its Subsidiaries, their respective operations, or the Meadow Products are in material violation of any applicable Law or Meadow Permits. (f) No Meadow Product has been or has been requested by a Governmental Authority or other Person to be recalled, withdrawn, removed, suspended, seized, the subject of a corrective action, or discontinued (whether voluntarily or otherwise). Neither Meadow, nor, to Meadow’s Knowledge, any Governmental Authority or other Person, has sought, is seeking, or, to Meadow’s Knowledge, has or is currently threatening or contemplating any Recall of a Meadow Product. (g) As required under applicable Law or pursuant to a Governmental Authorization, Meadow and its Subsidiaries have maintained, filed, or furnished to the applicable Governmental Entities or Person all documents required by the Securities Act and the Exchange Act and such filings, documents, as claims, reports, notices, and other submissions (the same may have been amended“Meadow Reports”), compliedrequired to be maintained, filed, or furnished on a timely basis, and, at the time filed with of maintenance, filing, or furnishing all such Meadow Reports were complete and accurate when submitted, or were subsequently updated, changed, corrected, or modified, except where the SECfailures to so maintain, file, furnish, update, change, correct or modify would not have a Meadow Material Adverse Effect. (h) Neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries has made an untrue statement of a material fact or fraudulent statement to the FDA or a Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or a Governmental Entity, or made a statement, or failed to make a statement that, would reasonably be expected to provide a basis for the FDA to invoke the FDA Ethics Policy. Neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries has ever been investigated by the FDA or other Governmental Entity for data or healthcare program fraud. Neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries is the subject of any pending or, to Meadow’s Knowledge, threatened investigation pursuant to the FDA Ethics Policy, or resulting from any other untrue or false statement or omission. (i) As of the date hereof, neither Meadow, its Subsidiaries, nor any Person providing services to Meadow or its Subsidiaries, nor their respective officers, directors, partners, employees, or agents have been: (i) debarred or suspended pursuant to 21 U.S.C. § 335a; (ii) excluded under 42 U.S.C. § 1320a-7 or any similar law, rule or regulation of any Governmental Entity; (iii) excluded, debarred, suspended or deemed ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration; (iv) charged, named in a complaint, convicted, or otherwise found liable in any Legal Proceeding that falls within the ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 000x, 00 X.X.X. § 000x, 00 X.X.X. § 0000x - 7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other applicable Law; (v) disqualified or deemed ineligible pursuant to 21 C.F.R. Parts 312, 511, or 812, or otherwise restricted, in whole or in part, or subject to an assurance; or (vi) had a pending Legal Proceeding, or otherwise received any written notice from any Governmental Entity or any Person threatening, investigating, or pursuing (i)-(v) above. (j) Meadow has not been restrained by a Governmental Authority nor other Person in its ability to conduct or have conducted the manufacturing, operation, storage, import, export, distribution, warehousing, packaging, labeling, handling, shipping, and/or nonclinical, clinical, or other testing of the Meadow Products. (k) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Meadow or any of its Subsidiaries, or in which Meadow or any of its Subsidiaries or the Meadow Products have participated, were and, if still pending, are being conducted in compliance in all material respects with all applicable Laws and regulations enforced by the Securities Act FDA or any comparable Governmental Entity, including, to the extent applicable, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812. The study reports, protocols, and statistical analysis plans for all such studies and tests accurately, completely, and fairly reflect the Exchange Actresults from such studies and tests. Xxxxxx has not received written notice of any complaints, information, or adverse drug experience reports related to a Meadow Product that would have a Meadow Material Adverse Effect. (cl) Neither CZFSAs of the date hereof, FCCB neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries has received any written notice, correspondence, or other written communications from the FDA, any other Governmental Entity, any IRB or other Person or board, such as, but not limited to, a data safety monitoring board, responsible for the oversight of the conduct of any study conducted by or on behalf of, or sponsored by, Meadow or any of their respective properties its Subsidiaries, or in which Meadow or any of the Meadow Products are participating, requiring or threatening the termination, hold, material adverse modification or suspension of any clinical study that is a party to being or is subject proposed to any Regulatory Order from any Governmental Authority charged be conducted. All clinical studies conducted or sponsored by or on behalf of Meadow or its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitationall applicable Laws, the PADOBS protocols, procedures and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bycontrols designed and approved for such studies, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement and in accordance with any individual requirement of an IRB or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS other Person or FCCB been advised in writing board responsible for review or oversight of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersuch studies.

Regulatory Matters. (a) Each Neither AstraZeneca, any of CZFSits Affiliates nor, CZFSAC and FCCB has timely filed all reportsto AstraZeneca’s Knowledge, registrations and statementsany Merck Party, together with or any amendments required to be made with respect theretoPerson on behalf of any of the foregoing, that it was required to file since January 1, 2020 with is Exploiting any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority Other Products in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterHorizon Territory. (b) Other than AstraZeneca, or an Affiliate of AstraZeneca, owns all Regulatory Approvals and Regulatory Documentation necessary to conduct the Product Business in the Horizon Territory as set forth currently conducted and such Regulatory Approvals are in CZFS Disclosure Schedule 4.11full force and effect. AstraZeneca has the right to grant the right of reference and use under the Licensed Regulatory Documentation to Horizon in accordance with the License Agreement. Neither AstraZeneca nor its Affiliates has received any written communication from any Governmental Authority threatening to withdraw or suspend any such Regulatory Approvals. No proceeding is pending or, since January 1to AstraZeneca’s Knowledge, 2020threatened regarding the revocation of any such Regulatory Approval. AstraZeneca and its Affiliates have not voluntarily or involuntarily surrendered, CZFS terminated or permitted to lapse or expire any Regulatory Approval used or maintained by them in the conduct of the Product Business, except where any such Regulatory Approval has timely been not renewed in the ordinary course of business. AstraZeneca or its Affiliates have filed with the SEC and NASDAQ applicable Governmental Authority all documents material filings, declarations, listings, registrations, reports or submissions, including adverse event reports required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed in connection with the SECconduct of the Product Business. All such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with all applicable Laws when filed, and no deficiencies have been asserted by any applicable Governmental Authority with respect to any such filings, declarations, listings, registrations, reports or submissions. Neither AstraZeneca nor any of its Affiliates is in violation of the Securities Act and terms of any Regulatory Approval for the Exchange ActHorizon Territory. (c) Neither CZFS, FCCB nor There has not been any product recall or market withdrawal or replacement conducted by or on behalf of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with AstraZeneca concerning the supervision or regulation of financial institutions or issuers of securities or engaged Product in the insurance Horizon Territory or any product recall, market withdrawal or replacement conducted by or on behalf of deposits (includingany Third Party as a result of any alleged defect in the Product in the Horizon Territory. AstraZeneca has made available to Horizon copies of material field alerts, without limitationdear doctor letters, complaints and notices of alleged defect or adverse reaction with respect to the PADOBS Product in the Horizon Territory that have been received in writing by AstraZeneca and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderits Affiliates. (d) The Product has been Manufactured in compliance with applicable Law, including cGMP, and applicable Regulatory Approvals. Neither CZFS AstraZeneca nor FCCB is a party to any agreement with Affiliate or Third Party engaged by it, in any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofcapacity, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed connection with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation Manufacture of the federal Bank Secrecy Product has received in the past [...***...] years or is currently subject to a Warning Letter (as defined in the Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued ) with respect to anti-money laundering any facility manufacturing Product for Exploitation in the Horizon Territory. Subject to backorders or delays in the ordinary course, AstraZeneca or its Affiliate has fulfilled all purchase orders submitted for the Product in the Horizon Territory. (e) All studies, tests and preclinical and clinical trials conducted by or on behalf of AstraZeneca or its Affiliates relating to the Product were conducted, and all studies, tests and trials currently being conducted by or on behalf of AstraZeneca or its Affiliates in connection with the clinical trials listed in Section 3.1.9(e) of the Disclosure Schedules are being conducted, in either case in all material respects in accordance with cGCP and other applicable Laws. AstraZeneca has completed all pediatric assessments or postmarketing commitments required by the U.S. Department FDA with respect to the Product in the Horizon Territory. Neither AstraZeneca nor any Affiliate of AstraZeneca has received any written notices or correspondence from any applicable Governmental Authority requiring the termination, suspension, material modification or clinical hold of any clinical trials listed in Section 3.1.9(e) of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderDisclosure Schedules.

Regulatory Matters. (a) Each The Product covered by this Agreement is registered with the Center for Veterinary Medicine of CZFS, CZFSAC the Food and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, Drug Administration (FDA). (i) KOFFOLK agrees that it was required to file since January 1, 2020 shall undertake in accordance with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and FDA regulations, and FCCB has a Community Reinvestment Act rating any other applicable laws or regulations, the submitting of “satisfactory” or betterperiodic drug experience reports to MERCK. (bii) Other than as set forth KOFFOLK further agrees to report to MERCK in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed writing all adverse experience and adverse physical occurrence information of which it becomes aware associated with the SEC Products relating to hazards, contraindications, side effects, injuries, toxicity, sensitivity reactions, Product defects and NASDAQ all documents required by mix-ups, whether or not the Securities Act and adverse experience or physical occurrence is determined to be causally related to the Exchange Act and such documents, as the same may have been amended, complied, at the time filed Products. This reporting obligation shall be in full compliance with the SECMERCK Policy and Procedure No. 4, in all material respects with "Reporting Adverse Experiences and Adverse Physical Occurrences for Animal Health Products," a copy of which is attached as Attachment 3 and incorporated herein by reference. KOFFOLK shall submit a copy of such report to MERCK within five (5) working days after learning of the Securities Act and adverse experience or physical occurrence using the Exchange Actrequired RA 1932 Form, a blank copy of which is attached as Attachment 4. (ciii) Neither CZFSWhen complete information is not available within the five-day period, FCCB nor KOFFOLK shall submit any available information within the five-day period, and also submit a supplement as soon as further details become available. MERCK shall be authorized to submit such adverse experience or physical occurrence information to government authorities as it considers appropriate. KOFFOLK agrees to permit MERCK to audit KOFFOLK's files for adverse drug experience or physical occurrence on a routine basis as determined necessary by MERCK. If MERCK becomes aware of their respective properties adverse experiences or physical occurrences which in its opinion may require a change in label content, MERCK shall provide KOFFOLK with all information relating to such adverse experiences or physical occurrences. (iv) KOFFOLK agrees to provide a signed statement identifying the category of its operation (i.e., wholesaler, retailer) and stating that it will distribute the Products only under labeling provided for in the new animal drug application for Product and approved by MERCK; that any other labeling or advertising for the drug will prescribe, recommend and/or suggest its use only under the conditions stated in the labeling provided for in the application; and that it is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or regularly and lawfully engaged in the insurance distribution of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderProduct. (dv) Neither CZFS nor FCCB is a party to KOFFOLK will advise MERCK immediately concerning any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofFDA inspections, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDICnotices, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued enforcement action with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderProduct.

Regulatory Matters. (a) Each Seller, or an Affiliate of CZFSSeller, CZFSAC possesses all Regulatory Approvals necessary to conduct the Product Business as currently conducted. The Purchased Regulatory Approvals are in full force and FCCB effect. No proceeding is pending or, to Seller’s Knowledge, threatened regarding the revocation of any Purchased Regulatory Approval. As of the Execution Date, neither Seller nor its Affiliates has timely filed all reports, registrations and statements, together with received any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by written communication from any Governmental Authority threatening to withdraw or suspend any Purchased Regulatory Approval. Neither Seller nor any of its Affiliates is in the regular course material violation of the business terms of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterPurchased Regulatory Approval. (b) Other than as set forth From the BLA Approval Date through the Execution Date, neither Seller, nor an Affiliate of Seller, has received any written communications from the FDA or any other Governmental Authority issuing, requiring, or causing any product recall, seizure, detention, market withdrawal, replacement, safety alert, warning, “dear doctor” letter or other notice or action relating to an alleged lack of safety or efficacy of the Product, any manufacturing deficiencies or any misbranding, and neither Seller nor an Affiliate of Seller has taken any such action voluntarily. Neither Seller nor an Affiliate of Seller is subject to any pending enforcement proceedings relating to the Product by the FDA or similar Governmental Authority and, to Seller’s Knowledge, no such proceedings have been threatened against Seller or any Affiliate of Seller. Seller has made available to Buyer copies of material complaints and notices of alleged defect or adverse reaction with respect to the Product that have been received in CZFS Disclosure Schedule 4.11writing by Seller and its Affiliates since the BLA Approval Date. (c) Since the BLA Approval Date, since January 1the Product has been Manufactured in compliance in all material respects with applicable Law in the Territory, 2020including cGMP, CZFS has timely filed and applicable Regulatory Approvals. Neither Seller nor any Affiliate nor, to Seller’s Knowledge, any Third Party engaged by Seller in connection with the SEC and NASDAQ all documents required by Manufacture of the Securities Act and Product has received in the Exchange Act and such documentstwo years prior to the Execution Date any FDA Form 483, Warning Letter, notice of violation letter or other written correspondence, notice or communication from the FDA or other comparable foreign Governmental Authority alleging or asserting noncompliance related to the Product with any applicable Laws with respect to any facility Manufacturing Product. (d) To Seller’s Knowledge, as of the same may have been amendedExecution Date, compliedSeller has made available to Buyer copies of any and all regulatory filings, at applications filed with, and all material written communications to and received by Seller and its Affiliates from the time filed FDA or comparable foreign Governmental Authority relating exclusively to the Product or exclusively to the operations of the Product Business, including any and all written notices of inspectional observations, establishment inspection reports, citations, decisions, warning or untitled letters and any other documents received by Seller or its Affiliates from the FDA or comparable foreign Governmental Authority that identify lack of compliance with the SECAct or comparable foreign Laws. (e) Seller and its Affiliates have conducted all Existing Clinical Trials and, to Seller’s Knowledge, all other clinical trials with respect to the Product, in all material respects (i) in accordance with cGCP and (ii) pursuant to valid protocols. Seller and its Affiliates have made all necessary material filings and received all necessary material approvals and consents for the Securities Act and conduct of the Exchange Act. (c) Neither CZFSExisting Clinical Trials from the necessary Governmental Authorities and, FCCB nor to Seller’s Knowledge, there is no Litigation pending or threatened by such Governmental Authorities to suspend or terminate any ongoing Existing Clinical Trials. Seller has not received any written notice, charge, subpoena or other request for information, which has not been complied with or withdrawn, from a Governmental Authority asserting any material breach of their respective properties is a party the conditions for approval of any Existing Clinical Trials for the Product. To Seller’s Knowledge, Seller has made available to or is subject Buyer all material information submitted to any Regulatory Order the FDA that has resulted from any Governmental Authority charged with the supervision research or regulation development activities conducted by or on behalf of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued Seller with respect to anti-money laundering by the U.S. Department Product. As of the Treasury’s Office of Foreign Assets ControlExecution Date, there are no ongoing clinical trials or any clinical trial commitments related to the Product, other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with than the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderclinical trial commitments set forth on Schedule 1.1.1.

Regulatory Matters. (a) Each In the event that laws, regulations or rules of CZFSthe Brazilian government or governmental agencies, CZFSAC including the Brazilian Central Bank, prohibit Itaú from (i) offering non-bank products inside its branches (and FCCB has timely filed pursuant to the applicable rules the Co-Branded Service is considered a non-bank product) or, (ii) carrying-out any in-branch marketing activities as provided for in this MOA (collectively a “Regulatory Event”), then Itaú will be released from all reportsobligations prohibited as a result of such Regulatory Event (“Prohibited Obligations”) after the date of the Regulatory Event (“Regulatory Event Date”). In the event a Regulatory Event results in all of or a material portion of Itaú’s in-branch marketing obligations under Sections 2(a) and (b) of this Exhibit A being deemed Prohibited Obligations, registrations and statements, together with any amendments required the Target Revenue Percentage shall be deemed to be made with respect theretozero for the remaining term of the SMA. In consideration for such release, that it was required Itaú shall pay AOLB the sum of (A) the product of (i) a Reference Payment for the Anniversary Year in which such Regulatory Event occurs calculated using the Revenue Elements generated and incurred during the period from the last Anniversary Date to file since January 1, 2020 with any Governmental Authoritythe Regulatory Event Date occurred, and has paid all fees (ii) a fraction, the numerator of which is the number of days from the last Anniversary Date to the Regulatory Event Date, and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority the denominator of which is 365, (B) if, in the regular course absence of the business release in the foregoing paragraph, the failure to perform a Prohibited Obligation(s) would result in any Marketing Payment, any such Marketing Payment that would be due for the Quarter in which the Regulatory Event Date occurs calculated based on Itaú’s performance of CZFSthe Prohibited Obligation(s) during the period beginning on the first day of the Quarter and ending on the Regulatory Event Date, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or and (C) the maximum Marketing Payment related to the Knowledge Prohibited Obligation(s) that could be due for those Quarters commencing after the Regulatory Event Date. In addition, if the Target Revenue Percentage is deemed to be zero due to such Regulatory Event, then AOLB shall have the option, after such Regulatory Event, to release Itaú from all of CZFSItaú ‘s marketing obligations hereunder, investigation into including without limitation, those obligations set forth in Sections 1(a), 1(d), 2, 3 and 5. In consideration for such release, Itaú shall pay to AOLB the business or operations maximum Marketing Payments that could be due for those Quarters commencing after the exercise of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersuch option. (b) Other than as set forth If any Brazilian judicial authority of competent jurisdiction determines that all Promoters and/or Supervisors deployed in CZFS Disclosure Schedule 4.11Itaú bank branches are deemed banking employees for purposes of determining the wages and benefits of Promoters and/or Supervisors, since January 1but not that such Promoters or Supervisors must be hired by or otherwise become employees of Itaú, 2020then, CZFS has timely filed within twenty days of AOLB’s receipt of written notice of such judicial determination from Itaú, AOLB shall notify Itaú in writing that it will either (i) bear one-half of the additional incremental expenses of the Promoters and Supervisors that are a direct result of such determination (and Itaú shall bear the other one-half of such amount), or (ii) decrease the number of Promoters and Supervisors required under this MOA (such decreased Promoters and Supervisors, the “Decreased Promoters”) such that the expenses associated with the SEC and NASDAQ all documents required by Decreased Promoters is equal to one half of the Securities Act and the Exchange Act and such documents, as the same may additional incremental expenses that would have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actincurred by Itaú as a direct result of such judicial determination without such a reduction. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than An “satisfactory”; (b) to Employee Labor Event” shall be deemed to have occurred if any Brazilian judicial authority of competent jurisdiction determines that all Promoters and/or Supervisors deployed in Itaú bank branches must be operating in material violation hired by or otherwise become employees of Itaú. At any time during the one-hundred twenty (120) day period after the occurrence of the federal Bank Secrecy ActEmployee Labor Event, as amendedItaú may elect to accept such determination, in which case it shall promptly so notify AOLB in writing, and its implementing regulations AOLB within twenty (31 C.F.R. Chapter X20) days after such notice shall notify Itaú in writing that (i) it will bear one-half of the additional incremental expenses of the Promoters and Supervisors that are a direct result of such determination (and Itaú shall bear the other one-half of such amount), or (ii) that it will decrease the USA PATRIOT Actnumber of Promoters and Supervisors required under this MOA (such decreased Promoters and Supervisors, and the regulations promulgated thereunder, any order issued “Decreased Promoters”) such that the expenses associated with respect the Decreased Promoters is equal to anti-money laundering by the U.S. Department one half of the Treasury’s Office additional incremental expenses that would have been incurred by Itaú as a direct result of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, such Employee Labor Event without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersuch a reduction.

Regulatory Matters. Except as is set forth in Section 4.12 of the Company Disclosure Letter: (a) Each Except as would not reasonably be expected to have a Material Adverse Effect, the Company and the Company Subsidiary are in compliance in all respects with all healthcare laws applicable to the operation of CZFS, CZFSAC and FCCB their respective businesses as currently conducted. Neither the Company nor the Company Subsidiary has timely filed all reports, registrations and statements, together received any written notice from the FDA or any other Governmental Body alleging noncompliance with any amendments required such provision of Law. Neither the Company nor the Company Subsidiary is subject to be made with respect thereto, that it was required any Legal Proceedings relating to file since January 1, 2020 with any Governmental Authorityor arising under the FDCA or similar Laws, and no such Legal Proceeding has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterbeen threatened. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely The Company and the Company Subsidiary have filed with the SEC FDA or any other Governmental Body all required filings, declarations, listings, notices, registrations, reports and NASDAQ all documents required by submissions, except where the Securities Act failure to make any filings, declarations, listings, notices, registrations, reports or submissions does not have, and would not reasonably be expected to have, individually or in the Exchange Act aggregate, a Material Adverse Effect. All such filings, declarations, listings, notices, registrations, reports and such documentssubmissions were in material compliance with applicable Laws when filed, as the same may remain in full force and effect, and no material deficiencies have been amendedasserted by any applicable Governmental Body with respect to any such filings, complieddeclarations, at the time filed with the SEClistings, in all material respects with the Securities Act notices, registrations, reports and the Exchange Actsubmissions. (c) To the Knowledge of the Company, except as set forth in documents made available to Parent or its Representatives prior to the date of this Agreement, all nonclinical and clinical investigations sponsored by the Company and the Company Subsidiary are being conducted in material compliance with applicable Laws, including Good Laboratory Practices, Good Clinical Practices, and federal and state laws, rules, regulations and guidance restricting the use and disclosure of individually identifiable health information. Neither CZFS, FCCB the Company nor the Company Subsidiary has received any of their respective properties is a party to written notice from the FDA or is subject any other Governmental Body with respect to any Regulatory Order from ongoing clinical trial or non-clinical trial or test requiring or recommending the termination, suspension or material modification of such studies or tests, or otherwise alleging noncompliance with any Governmental Authority charged applicable Laws with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of itrespect thereto. Neither CZFS the Company nor FCCB has been advised bythe Company Subsidiary is the subject of any pending or, or has any to the Knowledge of facts which could give rise to an advisory notice bythe Company, threatened, investigation by the FDA or any other Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderBody. (d) Neither CZFS nor FCCB is a party the Company, the Company Subsidiary nor, to the Knowledge of the Company, any agreement with of their respective officers, employees, agents or clinical investigators has been suspended or debarred or convicted of any individual crime or group regarding CRA engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar Law or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (e) Notwithstanding any other provision of this Agreement, the representations and warranties contained in this Section 4.12 constitute the sole and exclusive representations and warranties of the Company and the Company Subsidiary relating to FDA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS FDCA or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersimilar Laws.

Regulatory Matters. (a) Each Buyer is a bank holding company supervised by the FRB. (b) The Buyer Bank is a national banking association supervised by the OCC. The deposit accounts of CZFSthe Buyer Bank are insured by the FDIC to the fullest extent permitted by law. The Buyer Bank has paid or properly reserved or accrued for all current premiums and assessments with respect to such deposit insurance, CZFSAC all premiums and FCCB has timely filed all reports, registrations and statements, together with any amendments assessments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authoritypaid in connection therewith have been paid when due, and no proceedings for the termination of such insurance are pending or, to Buyer’s Knowledge, threatened. The Buyer Bank received a rating of at least “satisfactory” in its most recent examination or interim review under the Community Reinvestment Act. (c) Neither Buyer nor any of its Subsidiaries is party to, or the subject of, any cease-and-desist order, consent order, written agreement, order for civil money penalty, prompt corrective action directive, memorandum of understanding, supervisory letter, individual minimum capital requirement, operating agreement, or any other formal or informal enforcement action issued by, or entered into with, any Regulatory Authority. None of Buyer or any of its Subsidiaries has paid all fees and assessments due and payable made, adopted, or implemented any currently effective commitment, board resolution, policy, or procedure at the request or recommendation of any Regulatory Authority that limits in connection therewith. any material respect the conduct of its business or that in any material manner relates to its capital adequacy, its payment of dividends or distribution of capital, its credit or risk management, its compliance program, its management, its growth, or its business. (d) Except for normal examinations of Buyer and its Subsidiaries conducted by any Governmental Authority their respective primary regulators in the regular ordinary course of the business of CZFS, CZFSAC and/or FCCBbusiness, no Governmental Regulatory Authority has initiated or has pending any proceedingproceeding or, to Buyer’s Knowledge, any inquiry or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” Buyer or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties its Subsidiaries, except where such proceeding, inquiry, or investigation would not reasonably be likely to be, either individually or in the Table of Contents aggregate, material to Buyer and its Subsidiaries, taken as a whole. There is a party to no unresolved violation, apparent violation, criticism, matter requiring attention, recommendation, or is subject to exception cited, made, or threatened by any Regulatory Order from Authority in any Governmental Authority charged with the supervision report of examination, report of inspection, supervisory letter or regulation of financial institutions other communication that would reasonably be likely to be, either individually or issuers of securities or engaged in the insurance of deposits (includingaggregate, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise material to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, Buyer and its implementing regulations (31 C.F.R. Chapter X)Subsidiaries, the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, taken as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundera whole.

Regulatory Matters. (a) Each The Company and Company Subsidiaries have filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority performing functions similar to those performed by the FDA) all required material filings, declarations, listings, registrations, reports or submissions. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Law when filed, and no material deficiencies have been asserted in writing to any of CZFS, CZFSAC the Company and FCCB has timely filed all reports, registrations and statements, together with Company Subsidiaries by any amendments required to be made applicable Governmental Authority with respect theretoto any such filings, that it was required to file since January 1declarations, 2020 with any Governmental Authoritylistings, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFSregistrations, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, reports or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersubmissions. (b) Other than Except as set forth in CZFS Disclosure Schedule 4.11would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 2020, CZFS has timely filed with (i) the SEC Company and NASDAQ the Company Subsidiaries have and have had in effect all documents necessary and applicable Regulatory Permits required by any Health Authority to permit the Securities Act conduct of their respective businesses as currently conducted, (ii) all of such Regulatory Permits are in full force and effect and (iii) each of the Company and applicable Company Subsidiary is in compliance with, and is not in default under, each such Regulatory Permit. (c) Except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 2020, the Company, the Company Products, and the Exchange Act facilities in which the Company Products are developed, tested, made, processed, labeled, packaged, handled or stored are in compliance with all applicable requirements under applicable Health Laws, any comparable applicable foreign Laws, and all terms and conditions of all applicable Regulatory Permits. (d) Set forth on Section 4.13(c) of the Company Disclosure Letter is a list and description of all Regulatory Permits. Other than the Regulatory Permits in Section 4.13(c) of the Company Disclosure Letter and except as set forth in Section 4.13(c) of the Company Disclosure Letter, there are no additional Regulatory Permits required by any Health Authority to permit the conduct of their respective businesses as currently conducted, except where the failure to have such documentsRegulatory Permits would not reasonably be expected to have a Company Material Adverse Effect, individually or in the aggregate. (e) Except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 2020, none of the same may Company, any of the Company Subsidiaries or, to the Knowledge of the Company, any of their respective directors, officers, employees or agents has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any other Health Authority or (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Health Authority. None of the Company, any of the Company Subsidiaries or any of their respective directors, officers, employees or agents is the subject of any pending or, to the Knowledge of the Company, threatened investigation by the FDA, or the subject of any investigation by any other Health Authority or Governmental Authority, that, assuming such investigations were determined or resolved adversely, would be reasonably expected to have a Company Material Adverse Effect. (f) Except as would not reasonably be expected to have a Company Material Adverse Effect, neither the Company nor any of the Company Subsidiaries (i) has received any material written notice from any Health Authority or Governmental Authority (including a warning, untitled, or notice of violation letter or Form FDA 483) alleging any violation of, or non-compliance with, any Health Law, (ii) is subject to any material enforcement, regulatory or administrative proceedings against or affecting the Company or any Company Subsidiary relating to or arising under any Health Law and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened, or (iii) is a party to any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or other similar agreement, in each case, entered into with or imposed by any Governmental Authority, and no such action is pending as of the date hereof. (g) Since January 1, 2020, except as would not reasonably be expected to have a Company Material Adverse Effect, neither any the Company, Company Subsidiaries, nor any of their officers, directors, managers, employees, or agents are or have been: (i) excluded, suspended or debarred from participation, or are otherwise determined to be or identified as ineligible to participate, in any Governmental Health Program, (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any Governmental Health Program requirement or Law, (iii) to the Knowledge of the Company, the target or subject of any investigation relating to any offense of any Governmental Health Program, (iv) party to any individual integrity agreement, corporate integrity agreement or other formal or informal agreement (e.g., deferred prosecution agreement) with any Governmental Authority concerning any Health Law, (v) listed on the Office of Inspector General’s List of Excluded Individuals and Entities, (vi) listed on the General Services Administration’s published list of parties excluded from federal procurement programs and non-procurement programs, or (vii) subjected to any other debarment, exclusion or sanction list or database. (h) Except as set forth on Section 4.13(h) of the Company Disclosure Letter, all manufacturing operations conducted by or for the benefit of the Company and the Company Subsidiaries have been amended, complied, at the time filed with the SEC, conducted in compliance in all material respects with all applicable Health Laws, including good manufacturing practices regulations, and no Company Product has been recalled, withdrawn or suspended (whether voluntarily or otherwise) or has been adulterated or misbranded by the Securities Act and Company or a Company Subsidiary in a manner that would reasonably be expected to result in action by a Governmental Authority. No proceedings seeking the Exchange Actrecall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the Knowledge of the Company, threatened against the Company, nor have any such proceedings been pending at any time. (ci) Neither CZFS, FCCB the Company nor any of their respective properties is the Company Subsidiaries are considered to be Covered Entities or a party Business Associate pursuant to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderHIPAA. (dj) Neither CZFS nor FCCB is a party This Section 4.13 does not apply to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances existCompany Plans, which would cause CZFS or FCCB: (a) to be deemed not to be are covered in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderSection 4.9.

Regulatory Matters. (a) Each Within thirty (30) days after the Closing Date, Seller shall provide Buyer with complete copies of CZFS, CZFSAC Sellers Regulatory Approvals for the Products on the Territory and FCCB has timely filed all reports, registrations and statements, together with any amendments required correspondence or other documents reasonably related to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersuch Regulatory Approvals. (b) Other than as set forth in CZFS Disclosure Schedule 4.11Buyer irrevocably grants to Seller and its Affiliates the right to reference and quote the Regulatory Approvals and all portions thereof to support Seller's Product related activities outside of the Territory and to support any veterinary pharmaceutical products, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SECwhich Seller currently markets or sells or may, in all material respects with the Securities Act future, market or sell. Buyer shall not amend the Regulatory Approvals for the Bicillin(R) and Wycillin(R) Products during the Exchange Actrespective term of the Supply Agreement for each such Product without the prior written consent of Seller, such consent not to be unreasonably withheld, and Seller shall respond to Buyer's request for consent within thirty (30) days from such request. (c) Neither CZFSUpon transfer and assignment of each of the Regulatory Approvals to Buyer, FCCB nor any of their respective properties is a party to or is subject to any as provided in Section 2.5 and Section 6.8(d), and thereafter Buyer shall be solely responsible for conducting all activities in connection with such Regulatory Order from any Governmental Authority charged with Approvals for the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits Bicillin(R), Wycillin(R), and Nordette(R) Products, as applicable, including, without limitation, communicating, and preparing and filing all reports (including, without limitation, adverse drug experience reports) with the PADOBS appropriate Governmental Authorities in the Territory and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement interacting with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued third parties with respect to anti-money laundering Products sold or distributed in the Territory; provided, however, that for up to sixty (60) days after such transfer, Seller shall assist and cooperate in the transition of such activities to Buyer. Additionally, to the extent that Buyer is obligated, under Applicable Laws, to report to Governmental Authorities in the Territory, adverse drug experiences associated with Products sold by the U.S. Department or on behalf of Seller outside of the Treasury’s Office of Foreign Assets ControlTerritory, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be Seller shall provide Buyer with information about such adverse drug experiences in material compliance accordance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of this Section, and to the information security program adopted extent that Seller is obligated under Applicable Laws to report adverse drug experiences associated with Products sold by CZFS pursuant to 12 C.F.R. Part 000or on behalf of Buyer inside the Territory, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.Buyer shall

Regulatory Matters. (a) Each of CZFS, CZFSAC Seller and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authorityits Subsidiaries are, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFSpast three (3) years have been, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020in material compliance with applicable Regulatory Laws. FCCB is “well-capitalized” as defined in applicable laws and regulationsThe Products are being, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterin the past three (3) years have been, used, researched, developed, investigated, tested, labeled, manufactured, packaged, stored, imported, exported, and distributed in material compliance with all applicable Regulatory Laws. (b) Other than as set forth Neither Seller nor any of its Subsidiaries has received any written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, or arbitration from any Regulatory Authority alleging potential or actual material noncompliance by or liability of Seller or any of its Subsidiaries under any Regulatory Laws. Seller and its Subsidiaries have not received any written notice from a Regulatory Authority, nor to the Knowledge of Seller, there are no facts that would reasonably lead to such notice, that any Products cannot be used, researched, developed, investigated, tested, labeled, manufactured, packaged, stored, imported, exported, or distributed substantially in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required manner performed by or on behalf of the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActSeller. (c) Neither CZFSSeller and its Subsidiaries hold all Regulatory Authorizations required for the Programs as of the Closing, FCCB nor any and all such Regulatory Authorizations are in full force and effect, and to the Knowledge of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (includingSeller, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB no event has been advised byoccurred which allows, or has after notice or lapse of time would allow, revocation or termination thereof or would result in any Knowledge other material impairment of facts which could give rise to an advisory notice by, the rights of the holder of any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderAuthorization. (d) Neither CZFS Seller nor FCCB is a party any of its Subsidiaries has received from any Regulatory Authority any warning letter, untitled letter, FDA Form 483, prohibition notice, recall notice or equivalent in any jurisdiction with respect to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDICProducts, or otherwise) any written notice of any pending or threatened civil, criminal, administrative or regulatory claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration, inquiry, search warrant, subpoena (other than those related to actions against Third Parties), and to the Knowledge of Seller, there is not pending any allegation that any facts operation or circumstances exist, which would cause CZFS activity performed by Seller or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunderany of its Subsidiaries, or to be assigned a rating for CRA purposes by Bank Regulators on behalf of lower than “satisfactory”; (b) to be deemed to be operating Seller and any of its Subsidiaries, is in material violation of any Regulatory Law. (e) Except as set forth on Schedule 5.8(e) of the federal Bank Secrecy ActSeller Disclosure Schedules, as amendedneither Seller nor any of its Subsidiaries has, and its implementing regulations directly or indirectly (31 C.F.R. Chapter Xincluding through any Third Party subcontractor or sublicensee), the USA PATRIOT Actsponsored any IND or conducted any Clinical Trial for any Product. All ongoing and completed preclinical trials and Clinical Trials conducted by or on behalf of, and the regulations promulgated thereunderor sponsored by, Seller or any order issued of its Subsidiaries with respect to anti-money laundering by the U.S. Department Products have been conducted in all material respects in accordance with all applicable Regulatory Laws and all applicable trial protocols. Except as set forth on Schedule 5.8(e) of the Treasury’s Office Seller Disclosure Schedules, no preclinical trials or Clinical Trial conducted by or on behalf of Foreign Assets ControlSeller or any of its Subsidiaries with respect to the Products has been placed on full or partial clinical hold or has been terminated or suspended by a Regulatory Authority prior to completion. Neither Seller nor any of its Subsidiaries has received any written notice that any Governmental Authority, investigator, or any institutional review board or ethics committee or any other similar body has: (i) refused to approve any preclinical trial or Clinical Trial, or any substantial amendment to a protocol for any preclinical or Clinical Trial, conducted or proposed to be conducted by or on behalf of Seller or any of its Subsidiaries; (ii) initiated, or threatened to initiate, any action to suspend any preclinical trial or Clinical Trial conducted by or on behalf of Seller or any of its Subsidiaries, or suspend or terminate any application for any Regulatory Authorization, or otherwise restrict or delay the preclinical trial or Clinical Trial of any Product; or (iii) alleged that any preclinical trial or Clinical Trial conducted by or on behalf of Seller or any of its Subsidiaries are in material violation of applicable Regulatory Laws. (f) Except as set forth on Schedule 5.8(f) of the Seller Disclosure Schedules, Seller is the sole and exclusive owner of all of the Transferred Regulatory Documentation and neither Seller nor any of its Subsidiaries has granted any right of reference to any Person under any Transferred Regulatory Documentation. When submitted to the applicable Governmental Authorities, all Transferred Regulatory Documentation were true, complete, and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections, or modification to such Transferred Regulatory Documentation have been submitted to the applicable Governmental Authorities. During the past three (3) years, neither Seller nor any of its Subsidiaries has received written notice from any Governmental Authority regarding any revocation, withdrawal, suspension, cancellation, termination, or modification of any INDs or other Regulatory Approvals within the Transferred Regulatory Documentation and, to the Knowledge of Seller, there are no circumstances existing as of the Closing that would reasonably be expected to lead to any withdrawal of, loss of, or refusal to renew any such Transferred Regulatory Documentation. (g) In the past three (3) years, neither Seller nor any of its Subsidiaries nor, to the Knowledge of Seller, any employee or agent of the Seller or any of its Subsidiaries, has made an untrue statement of material fact or fraudulent statement to the FDA, any other Regulatory Authority, or any other Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA, any other Regulatory Authority, or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement, that, in each case, would reasonably be excepted to provide a basis for the FDA or any other Regulatory Authority to invoke the FDA Application Integrity Policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,” set forth in FDA’s Compliance Policy Guide Sec. 120.100 (CPG 7150.09) and in 56 Fed. Reg. 46191 (Sept. 11, 1991) or any similar policy or analogous Laws, in each case, as related to any Product, any Program, or any of the Transferred Assets. (h) Neither Seller nor any of its Subsidiaries have either voluntarily or involuntary initiated, conducted, issued, or caused to be initiated, conducted, or issued, any recall, field notification, field correction, withdrawal or replacement, safety alert or report, warning, “dear doctor” letter, investigator notice, or other notice or action, in each case, relating to an alleged lack of safety, efficacy, or regulatory compliance of any Product, and as of the date hereof, no Regulatory Authority has ordered, commenced, or, to the Knowledge of Seller, threatened to initiate any action to cause any such notice or action or any termination or suspension of distribution, development, or testing of any Product. (i) With respect to any and all biological materials included in the Transferred Assets: (i) such biological materials have in all material respects been obtained, stored, transferred, used, and disposed of in accordance with applicable anti-money laundering statuteLaws, rule including all applicable Regulatory Laws, and any generally accepted ethical guidelines regarding the collection, use, transport, and disposal of human tissue; (ii) all ethics committee approvals have been obtained to enable the use of any such biological materials obtained from patients or regulationhuman subject volunteers or other donors in connection with the Exploitation of any Product conducted by or on behalf of Seller or any of its Subsidiaries; and (iii) all uses of any such biological materials in the Exploitation of any Product conducted by or on behalf of Seller or any of its Subsidiaries fall within the terms of the informed consent given by the donors of such biological materials. (j) None of Seller or its Subsidiaries nor, to the Knowledge of Seller, any officers, employees or agents (including any distributor) thereof has been suspended or debarred or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar applicable Law, or (cii) exclusion under 42 U.S.C. Section 1320a-7 or any similar applicable Law, and, to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy Knowledge of Seller, no such action is contemplated, proposed or data security laws and regulations, including, without limitation, in Title V pending as of the Xxxxx-Xxxxx-Xxxxxx Act date of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderthis Agreement.

Regulatory Matters. (a) Each Assuming that, from the commencement of CZFSpower generation at each Operating Facility through the Acquisition Closing, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in each Operating Facility had continuously been a "qualifying cogeneration facility" within the regular course meaning of Section 3(18)(B) of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Federal Power Act, as amended, and its implementing the regulations of the FERC thereunder, at 18 C.F.R. Part 292, interpretations thereof by the FERC and courts of competent jurisdiction of the PURPA and such regulations (31 C.F.R. Chapter Xcollectively, PURPA, the regulations and all such interpretations, the "PURPA REQUIREMENTS"), each Operating Facility is, and since the USA PATRIOT Acquisition Closing has been, a "qualifying cogeneration facility" within the meaning of such requirements. Seller is not aware of any event or circumstances that would result in a loss by any of the Operating Facilities of such status. The consummation of the transactions contemplated by the Cogen Transaction Agreement and the Class B Contribution did not result in the loss of such status for such Operating Facility. (b) Each of Linden Venture, Camden Cogen and NJ Venture is an "exempt wholesale generator" as defined in Section 32 of PUHCA. (c) Since the Acquisition Closing, each of Linden Venture, Camden Cogen and NJ Venture has been in compliance with the Federal Power Act, as amended, and the FERC's regulations promulgated thereunder. (d) Except as set forth in SECTION 3.11 OF THE DISCLOSURE SCHEDULE, each of the Operating Facilities has in effect a contract with an entity under which such entity has agreed to purchase steam from such Operating Facility during the term of such contract and use such steam during such term for an industrial or commercial process or for heating or cooling, or has agreed to obtain cooling for chilling service from such Operating Facility, or both, in aggregate amounts which equal or exceed the projected amount of "useful thermal energy output" required for continued qualification of the facility as a qualifying cogeneration facility under the PURPA Requirements. All such uses of steam satisfy the requirements to be "useful thermal energy output" as defined in the PURPA Requirements. (e) None of the Company, Linden Venture, Camden Cogen or NJ Venture, or any order issued "affiliate" thereof, as defined in section 2(a)(11)(B) of PUHCA, is subject to regulation as a "public utility" under the Federal Power Act, other than as contemplated by 18 C.F.R. Section 292.601(c), or under any state law or regulation with respect to anti-money laundering the rates or the financial or organizational regulation of electric utilities, other than as contemplated by the U.S. Department 18 C.F.R. Section 292.602(c)(2). None of the Treasury’s Office of Foreign Assets ControlCompany or its Subsidiaries, including Linden Venture, Camden Cogen or NJ Venture, or any other applicable anti"affiliate" thereof, as defined in section 2(a)(11) of PUHCA, is subject to regulation as a "public-money laundering statuteutility company," a "holding company," a "subsidiary company," an "associate company," or an "affiliate" of any of a "public-utility company," a "holding company" or a "subsidiary company" of a "holding company," as each such term is defined in PUHCA. Assuming the accuracy of the representation in Section 4.06(a), rule none of Seller or regulation; the Company, the Subsidiaries or any "affiliate" thereof, as defined in section 2(a)(11) of PUHCA, requires any approvals under the Federal Power Act or PUHCA for the execution, delivery, or performance of the transactions contemplated by this Agreement. (cf) to be deemed Assuming the accuracy of the representation set forth in Section 4.06(c) and assuming that, from the commencement of power generation at each Operating Facility through the Acquisition Closing, each Operating Facility had continuously been a "qualifying cogeneration facility" within the meaning of the PURPA Requirements, consummation of the transactions contemplated by the Purchase Agreement and the Amended LLC Agreement by Seller will not to be in material compliance with the applicable requirements contained result in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, Operating Facilities losing its status as well as a "qualifying cogeneration facility" within the provisions meaning of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderPURPA Requirements.

Regulatory Matters. (a) Each of CZFS, CZFSAC All transferred Regulatory Filings and FCCB has timely filed all reports, registrations Regulatory Approvals are in full force and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettereffect. (b) Other than as set forth No litigation of any sort is pending or, to Seller’s knowledge, threatened in CZFS Disclosure Schedule 4.11writing regarding the revocation, since January 1cancellation, 2020rescission, CZFS suspension, withdrawal, material modification, or refusal to renew in the ordinary course any transferred Regulatory Filings or Regulatory Approvals, nor, to Seller’s knowledge, has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documentsany event occurred that would reasonably be expected to give rise to any right of notice, as the same may have been amendedmodification, compliedacceleration, at the time filed with the SECpayment, in all material respects with the Securities Act and the Exchange Actcancellation, withdrawal, limitation, or termination of a transferred Regulatory Filing or Regulatory Approval. (c) Neither CZFSSeller has not, FCCB nor and to Seller’s knowledge, none of its subcontractors or other vendors, has received any of their respective properties is a party to or is subject to any Regulatory Order written communication from any Governmental Authority charged threatening to revoke, cancel, rescind, suspend, withdraw, materially modify, or refuse to renew any transferred Regulatory Filing or Regulatory Approval that has not been withdrawn or otherwise remedied. Seller is not in violation of the terms of any transferred Regulatory Approval in any material respect. All fees and charges with respect to each transferred Regulatory Approval that have become due and payable have been paid in full, and all required applications, notices, and required filings (including any pending renewal applications, notices, or filings) with respect to the transferred Regulatory Approvals have been duly filed or made on a timely basis with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any appropriate Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderAuthorities. (d) Neither CZFS nor FCCB is a party to any agreement with any individual None of Seller or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofits Representatives, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department manufacturing or development of the Treasury’s Office Product or the Business, has been subject to physical inspections or received written inspection reports from any applicable Governmental Authority, in which such Governmental Authority has asserted or alleged in writing that the operations of Foreign Assets Control, Seller were or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed are not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderApplicable Laws.

Regulatory Matters. (a) Each The Company and the Company Subsidiaries hold all Permits issued by the FCC or the state public service or public utility commissions or other similar state regulatory bodies (“State PSCs”), and all other material regulatory Permits, including franchises, ordinances and other agreements granting access to public rights of CZFSway, CZFSAC issued or granted to the Company or any Company Subsidiary by a Governmental Entity (the “Company Licenses”) that are required for the Company and FCCB has timely filed each Company Subsidiary to conduct its business, as presently conducted. Section 3.16(a) of the Company Disclosure Letter sets forth a list of all reports, registrations and statementsCompany Licenses, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course name of the business entity holding such Company License. True correct and complete copies of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or each Company License (including all modifications and amendments thereto and waivers thereunder) have been made available to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterParent. (b) Other than as set forth Each Company License is valid and in CZFS Disclosure Schedule 4.11full force and effect and has not been suspended, since January 1revoked, 2020cancelled or adversely modified. No Company License is subject to (i) any conditions or requirements that have not been imposed generally upon licenses in the same jurisdictions, CZFS has timely filed with or (ii) any pending proceeding by or before the SEC and NASDAQ all documents required FCC or State PSCs to suspend, revoke or cancel such Company License, or any judicial review of a decision by the Securities Act and FCC or State PSCs with respect thereto. To the Exchange Act and knowledge of the Company, there has not been any event, condition or circumstance that would preclude any Company License from being renewed in the ordinary course (to the extent that such documents, as the same may have been amended, complied, at the time filed with the SEC, Company License is renewable by its terms). (c) Company License is in compliance in all material respects with such Company License and has fulfilled and performed all of its obligations with respect thereto, including all reports, notifications and applications required by the Securities Communications Act of 1934, as amended (the “Communications Act”), or the rules, regulations, written policies and orders of the FCC (together with the Communications Act, the “FCC Rules”) or similar state telecommunications laws (the “State Telecommunications Laws”) and the Exchange Act. rules, regulations, written policies and Orders of State PSCs (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged collectively with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (includingState Telecommunications Laws, without limitationthe, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA“PSC Rules”), and the regulations promulgated thereunderpayment of all regulatory fees and contributions, except for exemptions, waivers or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of similar concessions or allowances. Without limiting the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X)foregoing, the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department licensee of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be each Company License is in material compliance with the applicable requirements contained of the Federal and state Universal Service Fund programs, the Federal Telecommunications Relay Service programs, the Federal North American Numbering Plan Administration program, the Federal Local Number Portability Administration program (collectively, the “USF Programs”), the Communications Assistance to Law Enforcement Act (“CALEA”), and the FCC’s regulations concerning treatment and protection of Customer Proprietary Network Information (“CPNI”). All reports and other submissions required in connection with the USF Programs, CALEA, CPNI regulations, including contribution remittances, have been timely filed in materially true, correct and complete form. To the knowledge of the Company and the Company Subsidiaries, there are no pending or threatened investigations, inquiries, audits, examinations or other proceedings in connection with the performance of the Company and the Company Subsidiaries of their USF Programs, CALEA and CPNI obligations. (d) Except as set forth in Section 3.16(d) of the Company Disclosure Letter, neither the Company nor any Company Subsidiary has (i) implemented, or been alleged or found to have implemented, an unauthorized change of an end user’s carrier (“Slamming”) or (ii) placed or been alleged or found to have placed an unauthorized charge on customer billing (“Cramming”). (e) Except as set forth in Section 3.16(e) of the Company Disclosure Letter, the Company and all Company Subsidiaries have timely complied with any compensation, restoration, reimbursement, reporting, or other obligations arising in connection with public and private right-of-way access and pole attachment agreements. (f) Except as set forth in Section 3.16(f) of the Company Disclosure Letter, the Company and all Company Subsidiaries have timely submitted all required international traffic and circuit status reports in materially true, correct and complete form. Except as set forth in Section 3.16(f) of the Company Disclosure Letter, the licensee of each Company License is in material compliance with the applicable requirements of federal and state privacy or data security laws network outage reporting (“NOR”) requirements. All reports and regulationsother submissions required in connection with federal and state NOR requirements have been timely filed in materially true, including, without limitation, in Title V correct and complete form. To the knowledge of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 Company and regulations promulgated thereunderthe Company Subsidiaries, as well as there are no pending or threatened investigations, inquiries, audits, examinations or other proceedings in connection with the provisions performance of the information security program adopted Company and the Company Subsidiaries of their NOR requirements. (g) The Company or a wholly-owned Subsidiary of the Company directly or indirectly owns 100% of the Equity Interests and controls 100% of the voting power and decision-making authority of each holder of the Company Licenses. No Company License, Order or other agreement, obtained from, issued by CZFS pursuant or concluded with any State PSC would impose restrictions on the ability of any Company Subsidiary to 12 C.F.R. Part 000make payments, Xxxxxxx Xdividends or other distributions to the Company or any Company Subsidiary that limits, Xxxxxxxx D. Furthermoreor would reasonably be expected to limit, the CZFS Board has adopted cash funding and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions management alternatives of the USA PATRIOT Act and the regulations thereunderCompany on a consolidated basis in a manner disproportionate to restrictions applied by other State PSCs.

Regulatory Matters. (a) Each of CZFSNeither the Company, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in its Subsidiaries or the regular course Underlying Projects is a “holding company” or a “public-utility company” within the meaning of the business “Public Utility Holding Company Act of CZFS1935, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or as amended (“PUHCA”). CVPS is a “public utility company” and a “holding company” under PUHCA and claims exemption as a holding company pursuant to Rule 2 of the Knowledge of CZFS, investigation into Rules promulgated by the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterSecurities Exchange Commission under PUHCA. (b) Other than as set forth in CZFS Disclosure Schedule 4.11The Company, since January 1on behalf of itself, 2020its Subsidiaries and the Underlying Projects, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act any applicable foreign, state or local utility regulatory body and the Exchange Federal Energy Regulatory Commission (“FERC”), to the extent necessary to consummate this transaction, all material applications, forms, statements, reports, and documents (including all exhibits, amendments, and supplements thereto) required to be filed by it with respect to the Company, its Subsidiaries and the Underlying Projects under any applicable Laws, the Public Utility Regulatory Policies Act and such documentsof 1978, as the same may have been amendedamended (“PURPA”) and PUHCA and their respective rules and regulations thereunder, complied, at the time filed with the SEC, all of which complied in all material respects with all applicable requirements of the Securities Act appropriate act and the Exchange Actrules and regulations thereunder in effect on the date each such report was filed. (c) Neither CZFSBoth the Rumford and Ryegate Underlying Projects are “qualifying facilities” (“QF”), FCCB nor any within the meaning of PURPA and the rules and regulations promulgated thereunder, have maintained their respective properties is status as a party to QF at all times since their initial certification or is self-recertification as a QF, and are not currently subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (includingpending inquiry, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised byinvestigation, or has any Knowledge of facts which could give rise challenge relating to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderits status as a QF. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters Both of Sweetwater Wind 1 LLC and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing Sweetwater Wind 2 LLC are currently “exempt wholesale generators” (“EWG”) within the meaning of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, PUHCA and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Actregulations, and neither is currently subject to any pending inquiry, investigation, or challenge relating to its status as an EWG. To the regulations promulgated thereunderKnowledge of the Company, upon operational completion of the wind generation project for Sweetwater Wind 3 LLC, Sweetwater Wind 3 LLC will be a EWG and no facts, circumstances or conditions exist that, to the Knowledge of the Company, will subject Sweetwater Wind 3 LLC to any order issued investigation or challenge relating to the status as an EWG. The consummation of the transactions contemplated hereby will not adversely affect the “exempt wholesale generator” status of Sweetwater Wind 1 LLC or Sweetwater Wind 2 LLC or the proposed “exempt wholesale generator” status of Sweetwater Wind 3 LLC. (e) Both the Kavelstorf Windfarm and Eckolstadt Windfarm Project Companies are currently owned by CIC Luxembourg SaRL, which is an “EWG” within the meaning of PUHCA and its implementing regulations. Neither project is currently subject to any pending inquiry, investigation, or challenge relating to its status as a foreign utility company. The consummation of the transactions contemplated hereby will not adversely affect the “foreign utility company” status of either Kavelstorf Windfarm or Eckolstadt Windfarm Project Companies. (f) To the Knowledge of the Company, with respect to anti-money laundering by the U.S. Department Underlying Projects located in the United Kingdom, there are no events or circumstances reasonably likely to result in any of such Underlying Projects, upon operational completion of such Underlying Projects, not being either (i) a generator of “renewable source electricity” as defined in regulation 47 of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; Climate Change Levy (General) Regulations 2001 or (cii) to be deemed not to be capable of generating from renewable sources as set out in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V article 4 paragraph 10 of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderRenewables Obligation Order 2005.

Regulatory Matters. (ai) Each To each of CZFSthe Seller Parties’ Knowledge, CZFSAC each of the Seller Parties has each duly filed with the appropriate Governmental Authorities in substantially correct form the monthly, quarterly and FCCB has timely filed all reports, registrations and statements, together with any amendments annual reports required to be made with respect thereto, that filed by it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in under applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, reports were in all material respects complete and accurate and in material compliance with the Securities Act requirements of applicable laws and regulations, and the Exchange ActSeller Parties have previously delivered or made available to Purchaser Parties accurate and complete copies of all such reports. Except as Previously Disclosed, in connection with the most recent examinations of Seller Parties by the appropriate Governmental Authorities, the Seller Party was not required to correct or change any action, procedure or proceeding which Seller Party believes in good faith has not been now corrected or changed. (cii) Neither CZFSExcept as Previously Disclosed, FCCB nor none of the Seller Parties or any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision order, decree, directive, agreement, memorandum of understanding or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bysimilar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor has any Knowledge of facts which could give rise to an advisory notice bythe Seller Parties adopted any policies, procedures or board resolutions at the request or suggestion of, any Governmental Authority that such Authority. Each Seller Party has paid all material assessments made or imposed by any Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderAuthority. (diii) Neither CZFS nor FCCB Except as Previously Disclosed or as otherwise made available, no Seller Party is a party subject to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB no Governmental Authority has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended initiated since December 31, 20212008 or has pending any proceeding, filed with enforcement action, capital directive or, to the FDICKnowledge of any of the Seller Parties, investigation or otherwiseinquiry into the business, operations, policies, practices or disclosures of any Seller Party (other than normal examinations conducted by a Governmental Authority in the ordinary course of the business of Seller Parties, or, to the Knowledge of any of the Seller Parties, threatened any of the foregoing. (iv) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) The most recent regulatory rating given to be deemed not SL Bank as to be in satisfactory compliance with the CRA, and Community Reinvestment Act is “needs improvement.” Since the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by last regulatory examination of SL Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets ControlCommunity Reinvestment Act compliance, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that SL Bank has not been deemed ineffective by received any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT complaints as to Community Reinvestment Act and the regulations thereundercompliance.

Regulatory Matters. (a) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since Since January 1, 2020 with any Governmental Authority2018, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFSAB, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws AB and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may each AB Subsidiary have been amended, complied, at the time filed with the SEC, complied in all material respects with the Securities Act with, and the Exchange Act. are not in default or violation in any material respect of, (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requestingi) any Regulatory Order. (d) Neither CZFS nor FCCB is a party applicable Laws, including without limitation all Laws related to any agreement with any individual data protection or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X)privacy, the USA PATRIOT Act, the Bank Secrecy Act, the Equal Credit Opportunity Act and Regulation B, the Fair Housing Act, the Community Reinvestment Act, the Fair Credit Reporting Act, the Truth in Lending Act and Regulation Z, the Home Mortgage Disclosure Act, the Fair Debt Collection Practices Act, the Electronic Fund Transfer Act, the Xxxx-Xxxxx Xxxx Street Reform and Consumer Protection Act, any regulations promulgated by the Consumer Financial Protection Bureau, the Real Estate Settlement Procedures Act and Regulation X and any other Laws or regulations relating to bank secrecy, discriminatory lending, financing or leasing practices, money laundering prevention, and all requirements relating to the origination, sale and servicing of mortgage and consumer loans and (ii) any posted or internal privacy policies relating to data protection or privacy, including without limitation, the protection of personal information, and AB has no Knowledge of, nor has it received since January 1, 2018, written notice of, any defaults or violations of any applicable Law. (b) None of AB or any AB Subsidiary are a party to any cease and desist order, written agreement, or memorandum of understanding with, or a party to any commitment letter or similar undertaking to, or are subject to any order or directive by, or are a recipient of any extraordinary supervisory letter from, or have adopted any board resolutions that continue to be effective on or after the Execution Date at the request of, federal or state regulatory authorities, nor have any of them been advised by such authorities that they are contemplating issuing or requesting any such order, agreement, memorandum or similar document or undertaking. (c) Each of AB and the regulations promulgated thereunderAB Subsidiaries has, to the Knowledge of AB, administered all accounts for which it acts as a fiduciary, including accounts for which they serve as a trustee, agent, custodian, personal representative, guardian, conservator or investment advisor, materially in accordance with the terms of the governing documents and applicable Law. None of AB, any order issued AB Subsidiary, or any director, officer, or employee of AB or any AB Subsidiary have, to the Knowledge of AB, committed any material breach of trust or fiduciary duty with respect to any such fiduciary account, and the accountings for each such fiduciary account accurately reflect in all material respects the assets of such fiduciary account. (d) None of AB or any AB Subsidiary, nor, to the Knowledge of AB, any of their respective directors, officers, employees, agents, or any other persons acting on their behalf, (i) have violated the Foreign Corrupt Practices Act, 15 U.S.C. Sections 78dd-1 et seq., as amended, or any other similar applicable foreign, federal or state legal requirement, (ii) have made or provided, or caused to be made or provided, directly or indirectly, any payment or thing of value to a foreign official, foreign political party, candidate for office or any other person while knowing or having a reasonable belief that the person will pay or offer to pay the foreign official, party or candidate, for the purpose of influencing a decision, inducing an official to violate their lawful duty, securing an improper advantage, or inducing a foreign official to use their influence to affect a governmental decision, (iii) have paid, accepted or received any unlawful contributions, payments, expenditures or gifts, (iv) have violated or operated in noncompliance with any export restrictions, money laundering Law, anti-money laundering terrorism Law or regulation, anti-boycott regulations or embargo regulations, or (v) are currently subject to any United States sanctions administered by the U.S. Department of the Treasury’s Office of Foreign Assets ControlControl of the United States Treasury Department. (e) To the extent that either AB or the Bank has originated or otherwise participated in any program or benefit created or modified by the Covid-19 Relief Acts, or any other applicable anti-money laundering statuteincluding but not limited to the PPP, rule or regulation; or (c) to be deemed not to be it has done so in good faith and in material compliance with all Laws governing such program, including but not limited to all regulations and guidance issued by the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of SBA with the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS respect to loans originated pursuant to 12 C.F.R. Part 000or in association with the PPP. To the extent that either AB or the Bank has originated or otherwise participated in the PPP, Xxxxxxx X, Xxxxxxxx D. Furthermore, it has done so in good faith and in material compliance with all applicable Laws in effect at the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundertime.

Regulatory Matters. (a) Each of CZFSSellers, CZFSAC Parent Companies and FCCB has timely Buyer (as applicable under the relevant Antitrust and/or FDI Laws) shall, as soon as reasonably practicable: (i) file Notification and Report Forms under the HSR Act (the “HSR Filing”) with the Federal Trade Commission and the Antitrust Division of the United States Department of Justice, (ii) file or cause to be filed all reports, registrations and statements, together the Communications Authorizations Filings necessary to obtain any Communications Authorizations Consents or to maintain compliance with any amendments required of the Communications Authorizations or any Order or Law or relating to the Communications Authorizations, (iii) file or cause to be made filed the FDI Authorizations Filings of the jurisdictions set forth in Schedule 7.7(a), (iv) submit the filings, pursuant to Antitrust Laws of the jurisdictions set forth in Schedule 9.1(a), (v) within five days following the Closing, submit any five-day notification that is required pursuant to 22 C.F.R. § 122.4(a) of the International Traffic in Arms Regulations (22 C.F.R. §§ 120-130, as amended) and (vi) file or cause to be filed any post-Closing notifications, registrations, or other filings to maintain compliance with any of the Communications Authorizations or any Order or Law or relating to the Communications Authorizations. With respect theretoto the Investment Canada Act Approval, within ten (10) Business Days after the Signing Date or such other date that it was required the Parties mutually agree to, Xxxxx will make the filing prescribed under section 12 of the Investment Canada Act (the “ICA Notification”). Subject to file since January customary confidentiality protections, each of Sellers, Parent Companies and Buyer (as applicable under the relevant Antitrust Laws and/or FDI Laws) shall furnish to the other in a timely manner such reasonably necessary information and reasonable assistance as the other may request in connection with its preparation of the HSR Filing, any Communication Authorizations Filing, the ICA Notification, any FDI Authorizations Filings and any other filing or submission that is necessary under the HSR Act or other applicable Antitrust Law or FDI Law or other Laws or regulations. To the extent permitted by Law and the applicable Governmental Authority, each of the Parent Companies and Buyer will promptly inform the other Party of any material communication received by such Party from any Governmental Authority relating to the HSR Filing or the Communications Authorizations Filings, the FDI Authorizations Filings or the ICA Notification. Subject to the other terms hereof (including Section 7.7(b)), each of Sellers, Parent Companies and Buyer will (A) use reasonable best efforts to obtain Investment Canada Act Approval; (B) use its respective reasonable best efforts to comply as expeditiously as possible with all requests of any Governmental Authority for additional information and documents, including information or documents requested under the HSR Act or other applicable Antitrust Law or FDI Law, the Communications Act or the rules and regulations of the FCC or the International Communications Governmental Authorities or other Laws or regulations; (C) not (1, 2020 ) extend any waiting period under the HSR Act or any applicable Antitrust Law or FDI Law or (2) enter into any agreement with any Governmental AuthorityAuthority not to consummate the Transactions, except, in each case, with the prior consent of the other Parties; and (D) cooperate with the other Parties and use reasonable best efforts to contest and resist any Action, including legislative, administrative or judicial action, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by to have vacated, lifted, reversed or overturned any Governmental Authority in Order (whether temporary, preliminary or permanent) that restricts, prevents or prohibits the regular course consummation of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterTransactions. (b) Other than as set forth Notwithstanding the foregoing: (i) nothing in CZFS Disclosure Schedule 4.11this Section 7.7 shall require any Party to provide or cause to be provided any information that is prohibited or restricted by applicable Law or applicable confidentiality undertaking, since January 1, 2020, CZFS has timely filed with or that constitutes privileged information or attorney client work privilege and (ii) materials may be redacted to address the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actforegoing or other reasonable privilege or confidentiality concerns. (c) Neither CZFSBuyer shall not, FCCB nor and shall cause Parent and its controlled Affiliates to not, acquire or agree to acquire by merging or consolidating with, or by purchasing a portion of the assets of or equity in, or by any other manner, any Person or portion thereof, or otherwise acquire or agree to acquire any assets, if the entering into of their respective properties is a party definitive agreement relating to or is subject the consummation of such acquisition, merger or consolidation would reasonably be expected to (i) impose any Regulatory Order from material delay in the obtaining of, or materially increase the risk of not obtaining, any authorizations, consents, orders, declarations or approvals of any Governmental Authority charged with necessary to consummate the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) Transactions or the supervision expiration or regulation termination of it. Neither CZFS nor FCCB has been advised byany applicable waiting period, or has any Knowledge (ii) materially increase the risk of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing entering an order prohibiting the consummation of the Transactions, including the Closing, or requesting (or is considering iii) materially delay the appropriateness of issuing or requesting) any Regulatory OrderClosing. (d) Neither CZFS nor FCCB is a party Buyer shall bear the cost of any filing fees payable to Governmental Authorities in connection with the HSR Filing and the FDI Authorizations Filings. Subject to the foregoing (but notwithstanding any agreement other provision of this Agreement), each Party shall bear its own costs associated with responding to and complying with any individual additional information or group regarding CRA matters documentary request made pursuant to the HSR Act or another filing required pursuant to a Regulatory Approval. (e) The Parties acknowledge and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) agree that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRABuyer shall control and direct, and the regulations promulgated thereunderSellers and Parent Companies will cooperate reasonably, or subject to be assigned a rating for CRA purposes by Bank Regulators applicable Law, with such direction and control, the defense of lower than “satisfactory”; (b) to be deemed to be operating in material violation of this Agreement and the federal Bank Secrecy Act, as amendedTransactions before any Governmental Body and the scheduling of, and its implementing regulations (31 C.F.R. Chapter X)strategic planning for, the USA PATRIOT Actany meetings with, and the regulations promulgated thereunderconducting of negotiations with, Governmental Authorities regarding (i) the expiration or termination of any order issued applicable waiting period relating to the Transactions under the HSR Act, and/or (ii) obtaining any consent, approval, waiver, clearance, authorization or permission from a Governmental Authority with respect to anti-money laundering by obtaining all Regulatory Approvals; provided, however, that Buyer shall afford the U.S. Department Company Group a reasonable opportunity to participate therein; provided, further, that, Buyer shall consult with and consider in good faith the views of the Treasury’s Office Sellers and Parent Companies regarding the form and content of Foreign Assets Controlany such actions. No Party shall permit any of its officers or other Representatives to participate in any substantive meeting, telephone call or conference with any other applicable anti-money laundering statuteGovernmental Authority in respect of any filing, rule investigation or regulation; or (c) otherwise relating to be deemed not the Transactions unless, to be in material compliance the extent reasonably practicable, it consults with the applicable requirements contained other Party in advance and, to the extent permitted by such Governmental Authority, gives the other Party the opportunity to attend and participate therein. The Parties shall use reasonable best efforts to furnish to give the other Party reasonable prior notice of any federal such filing and, to the extent practicable, keep the other Party reasonably informed with respect to the status of each Regulatory Approval sought from a Governmental Authority in connection with the Transactions and state privacy the material communications between such Party and such Governmental Authority, and, to the extent practicable, permit the other Party to review and discuss in advance, and consider in good faith the views of the other Party in connection with any such filing or data security laws and regulations, including, without limitationcommunication. (f) Subject to Section 7.7(b), in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective event any Action by any Governmental Authority and that meets or other Person is commenced which questions the requirements of Sections 352 and 326 and all other applicable provisions validity or legality of the USA PATRIOT Act Transactions or seeks damages in connection therewith, the Parties agree to cooperate and use reasonable best efforts to defend against such Action and, if an Order is issued in any Action, to use reasonable best efforts to have such Order lifted, and to cooperate reasonably regarding any other impediment to the regulations thereunderconsummation of the Transactions prior to the End Date.

Regulatory Matters. (a) Each FBMS and The First are “well-capitalized,” as such term is defined in the applicable state and federal banking rules and regulations (b) FBMS is regulated as a bank holding company under the Bank Holding Company Act of CZFS1956, CZFSAC as amended. (c) The deposit accounts of The First are insured by the FDIC through the Deposit Insurance Fund to the fullest extent permitted by Law, and FCCB all premiums and assessments required to be paid in connection therewith have been paid when due, and no proceedings for the termination of such insurance are pending or, to FBMS’s Knowledge, threatened. The First received a rating of “satisfactory” in its most recent examination under the Community Reinvestment Act. (d) Neither FBMS nor any of its Subsidiaries is subject to any cease-and-desist or other similar order issued by, or is a party to any written agreement, consent agreement or memorandum of understanding with, or is a party to any commitment letter or similar undertaking to, or is a recipient of any extraordinary supervisory letter from, or is subject to any order or directive by, or has adopted any board resolutions at the request of any Governmental Authority (each a “FBMS Regulatory Agreement”) that restricts, or by its terms will in the future restrict, in any material respect, the conduct of FBMS’s or any of its Subsidiaries’ business or that in any manner relates to their capital adequacy, credit or risk management policies, dividend policies, management, business or operations, nor has HSBI or any of its Subsidiaries been advised by any Governmental Authority that it is considering issuing, initiating, ordering, requesting, recommending or otherwise proceeding with (or is considering the appropriateness of any of the aforementioned actions) any FBMS Regulatory Agreement. To FBMS’s Knowledge, there are no investigations relating to any regulatory matters pending before any Governmental Authority with respect to FBMS or any of its Subsidiaries. amended. (e) Since January 1, 2019, FBMS and each of its Subsidiaries has timely filed with the SEC, the Office of the Comptroller of the Currency, the FRB, the FDIC, the MDBCF, any applicable SRO and any other applicable Governmental Authority, in correct form in all material respects, all reports, registrations registration statements and statements, together with any amendments other documents required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, filed under applicable Laws and has regulations and have paid all fees and assessments due and payable in connection therewith. , and such reports were complete and accurate and in compliance in all material respects with the requirements of applicable Laws and regulations. (f) Except for normal examinations conducted by any a Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCBFBMS and its Subsidiaries, no Governmental Authority has notified FBMS that it has initiated or has pending any proceedingproceeding or, or to the Knowledge of CZFS, FBMS threatened an investigation into the business or operations of CZFS, CZFSAC and/or FCCB, FBMS or any of its Subsidiaries since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better2019. (bg) Other than as set forth in CZFS Disclosure Schedule 4.11There is no unresolved violation, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to criticism or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective exception by any Governmental Authority and that meets the requirements with respect to any report filed by, or relating to any examinations or inspections by any such Governmental Authority of Sections 352 and 326 and all other applicable provisions FBMS or any of the USA PATRIOT Act and the regulations thereunderits Subsidiaries.

Regulatory Matters. (a) Each Schedule 3.12(a) of CZFSthe Buyer Disclosure Letter sets forth a true and complete list as of the date hereof of all of the Buyer Products, CZFSAC including the dosage form, active ingredient and FCCB strength of each such Buyer Product. In respect of the Buyer Products, Schedule 3.12(a) of the Buyer Disclosure Letter sets forth (i) a description of the regulatory status thereof (as of the date hereof), including the pending or approved NDAs or ANDAs that any of the Buyer Entities has timely submitted to the FDA in respect of such Buyer Products (collectively, “Buyer Filed NDAs”); and (ii) whether the particular regulatory status has been presented to the FDA or any other Governmental Entity under the name of one of the Buyer Entities, or under the name of another Person. Copies of the Buyer Filed NDAs and any other material filings or submissions made by the Buyer Entities with the FDA or any other Governmental Entity (1) were reviewed before filing by an employee or other agent of one of the Buyer Entities who is knowledgeable about the contents of the filing and, were true and accurate in all material respects when filed all reports(subject to correction, registrations and statements, together with any amendments amendment or supplementation by subsequent filings as required to be made with respect thereto, that it was required to file since January 1, 2020 with any by the FDA or other Governmental AuthorityEntity), and has paid all fees and assessments due and payable were made in connection therewith. Except for normal examinations conducted by any Governmental Authority in good faith upon the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or best information reasonably available to the Knowledge of CZFS, investigation into Buyer Entities; and (2) have been made available to the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterCompany upon its request. (b) Other than Except as set forth in CZFS Schedule 3.12(b) of the Buyer Disclosure Schedule 4.11Letter, the conduct and operation of the Buyer Business is, and at all times since January 1the Reference Date has been, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in compliance in all material respects with the Securities Act FDC Act, and applicable regulations issued by the Exchange FDA and all other applicable Laws, including any regulatory Laws of any applicable non-U.S. jurisdiction, and in all material respects with all reporting requirements under the FDC Act. , the Controlled Substances Act, as amended, the associated rules and regulations promulgated thereunder and all other applicable Laws. Without limiting the generality of the foregoing, except as set forth in Schedule 3.12(b) of the Buyer Disclosure Letter, (ci) Neither CZFSthe Buyer Entities have obtained all material clearances, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from authorizations, licenses and registrations required by any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits Entity (including, without limitation, the PADOBS FDA, DEA or any other Governmental Entity, domestic or foreign, performing functions similar to those performed by the FDA or DEA) to permit the conduct of the Buyer Business as currently conducted, (ii) the Buyer Entities have filed with each applicable Governmental Entity (including, without limitation, the FDA, DEA or any other Governmental Entity, domestic or foreign, performing functions similar to those performed by the FDA or DEA) all material, required filings, declarations, listings, registrations, reports or submissions, including but not limited to Adverse Event reports and all manufacturing changes to the FRBBuyer Products, (iii) complete and correct copies of all such documents referred to in the immediately preceding clause (ii) have been delivered to the Company and (iv) all such filings, declarations, listings, registrations, reports or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bysubmissions were in compliance in all material respects with applicable Laws when filed, or has subsequently corrected, and no deficiencies have been asserted by any Knowledge of facts which could give rise applicable Governmental Entity to an advisory notice bythe Buyer Entities with respect to any such filings, any Governmental Authority that such Governmental Authority is contemplating issuing declarations, listing, registrations, reports or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordersubmissions. (dc) Neither CZFS nor FCCB Each Buyer Product is a party to any agreement with any individual or group regarding CRA matters being, and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31past three (3) years, 2021researched, filed developed, tested, manufactured, supplied, distributed, and stored by or on behalf of the Buyer Entities in compliance in all material respects with the FDICFDC Act, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Controlled Substances Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, associated rules and the regulations promulgated thereunder, any order issued including, as applicable, those requirements relating to the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices, all filings, declarations, listings, registrations, reports or submissions of the Buyer or its Subsidiaries to Governmental Entities relating to such Buyer Product (including with respect to anti-money laundering all Buyer Product specifications), and all other applicable Laws, including any rules and regulations of any other Governmental Entity, domestic or foreign, performing functions similar to those performed by the U.S. Department of FDA or DEA. (d) All preclinical studies and clinical trials sponsored by the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be Buyer Entities have been conducted in material compliance with the applicable requirements contained in any Laws, rules and regulations and Good Clinical Practices, and federal and state privacy or data security laws Laws, rules and regulations, including, without limitationall applicable security laws and privacy standards restricting the use and disclosure of individually identifiable health information. Scientific reports of such investigations have been, or will be, drafted in all material respects according to applicable requirements and raw data adequately archived and available for inspection by the applicable Governmental Entities. None of the Buyer Entities has received any written notices or other correspondence from the FDA or any other foreign, federal, state or local Governmental Entity performing functions similar to those performed by the FDA with respect to (i) requiring the termination, suspension or material modification of ongoing clinical trials or pre-clinical studies, (ii) adverse inspection reports, (iii) notices of adverse findings, warning letters, untitled letters or (iv) other correspondence asserting that the Buyer Entities may not be in compliance with applicable Laws or that the Buyer Products or any compounds contained in the Buyer Products may not be approvable. (e) Since the Reference Date, none of the Buyer Entities has been subject to any investigation related to the Buyer Products or the conduct and operation of the Buyer Business that is pending and of which the Buyer Entities has been notified in writing or which (to the Buyer’s Knowledge) has been threatened, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective each case by any Governmental Authority Entity pursuant to the Medicaid rebate law (42 U.S.C. § 1396r-8), the Veterans Health Care Act of 1992, the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b), the Federal False Claims Act (31 U.S.C. §3729) or any similar anti-kickback or false claims statutes applicable to the Buyer Entities. Since the Reference Date, none of the Buyer Entities has submitted any claim for payment to any government healthcare program in connection with any referrals related to the Buyer Products that violated in any material respect any applicable self-referral Law. Since the Reference Date, none of the Buyer Entities has submitted any claim for payment to any government healthcare program related to the Buyer Products in material violation of any Laws relating to false claim or fraud. (f) Since the Reference Date, neither the Buyer Entities nor, to the Buyer’s Knowledge, any of the Representatives acting on behalf of the Buyer Entities has been under investigation for, nor has (i) made an untrue statement of material fact or fraudulent statement to any Governmental Entity, failed to disclose a material fact required to be disclosed to any Governmental Entity, or committed an act, made a statement, or failed to make a statement, including with respect to any scientific data or information, that, at the time such disclosure was made or failure to disclose occurred, would reasonably be expected to provide a basis for the Governmental Entity to invoke the FDA policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), in each case as related to the Buyer Products or the conduct or operation of the Buyer Business, (ii) been convicted of any crime or engaged in any conduct for which disqualification, exclusion or similar action is authorized by a Governmental Entity in relation to the development or approval of any pharmaceutical product, including for which debarment is mandated by 21 U.S.C. § 335a(a) or authorized by 21 U.S.C. § 335a(b) or (iii) been convicted of any crime or engaged in any conduct for which such Person or entity could be excluded from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended. (g) Since the Reference Date, none of the Buyer Entities have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, field corrections, market withdrawal, safety alert or warning, “dear doctor” letter, investigator notice or other material notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of the Buyer Products. None of the Buyer Entities has knowledge of any facts that meets are reasonably likely to cause (i) the requirements recall, market withdrawal or replacement of Sections 352 any Buyer Product, (ii) a material change in the marketing classification or a material change in the labeling of any Buyer Product, or (iii) a termination or suspension of the marketing of any Buyer Product. Since the Reference Date, none of the Buyer Entities has received any written notice that any Governmental Entity has: (1) commenced, or threatened to initiate, any action to request the recall of any Buyer Product; (2) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any Buyer Product; (3) issued any demand letter, finding of material deficiency or non-compliance or adverse inspection report (including any FDA Form 483s, FDA Notices of Adverse Findings, Untitled Letters, or Warning Letters) in respect of any Buyer Product; or (4) commenced, or threatened to initiate, any action regarding inappropriate advertising or marketing of any Buyer Product, nor to the Buyer’s Knowledge do any conditions currently exist that reasonably could be expected to lead to any of the foregoing. (h) The Buyer has delivered to the Company complete and 326 correct copies of all material scientific, CMC (including any supply chain risk assessments), preclinical, and clinical data of the Buyer Entities, all material non-clinical and safety risk assessments, and all other applicable provisions of the USA PATRIOT Act and the regulations thereundermaterial written correspondence with all Governmental Entities, in each case with respect to any Buyer Product.

Regulatory Matters. (a) Each The Borrower, each of CZFS, CZFSAC its Subsidiaries and FCCB has timely filed all reports, registrations the Borrower’s agents and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course agents of each of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined Borrower’s Subsidiaries are in compliance in all material respects with all applicable laws and regulationsregulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and FCCB has a Community Reinvestment Act rating all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Borrower and each of “satisfactory” its Subsidiaries have and maintains in full force and effect all material Regulatory Authorizations. The Borrower and each of its Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FDCA or betterequivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Borrower and each of its Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities, labeling, advertising, promotion, Product descriptions and claims for the Products related thereto. (b) Other than as set forth in CZFS Disclosure Schedule 4.11All notices, since January 1registrations and listings, 2020supplemental applications or notifications, CZFS has timely reports (including field alerts, medical reports or other reports of adverse experiences) and other filings required by any Regulatory Authority with respect to the Products have been filed with the SEC FDA and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actany other applicable Governmental Authority. (c) Neither CZFS, FCCB the Borrower nor any of its Subsidiaries has introduced into commercial distribution any Products manufactured by or on behalf of the Borrower or its Subsidiaries that were upon their respective properties is a party to shipment by the Borrower or is subject to any Regulatory Order of its Subsidiaries adulterated or misbranded and all Products are and have been labeled, promoted, and advertised in accordance with their Registrations and approved labeling or within the scope of an exemption from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that obtaining such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderRegistration. (di) Neither CZFS nor FCCB is a party The Borrower and its Subsidiaries and, to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge oftheir knowledge, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAtheir respective suppliers are, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating have been in material violation of the federal Bank Secrecy Act, as amendedcompliance with, and its implementing regulations (31 C.F.R. Chapter X)each Product in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced, and processed in material compliance with, the USA PATRIOT Act, applicable Regulatory Authority manufacturing requirements; and (ii) the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be Borrower and its Subsidiaries are in material compliance with the written procedures, record-keeping and reporting requirements required by the FDA or any other applicable requirements contained in any federal and state privacy or data security laws and regulationsGovernmental Authority pertaining to the reporting of adverse events involving the Products, including, without limitationas the case may be, the FDA’s Safety Reporting Portal, the FDA’s MedWatch, or the FDA’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS). (e) Except as provided in Title V Schedule 3.30(e), neither the Borrower nor any of its Subsidiaries has received from any Regulatory Authority any notice of adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto, including any FDA Form 483 inspectional observations, notices of violations, warning letters, criminal proceeding notices under Section 305 of the Xxxxx-Xxxxx-Xxxxxx Act FDCA, or any other similar communication from any Regulatory Authority. There have been no seizures conducted or threatened by any Regulatory Authority with respect to any Product, and no recalls, market withdrawals, field notifications, notifications of 1999 misbranding or adulteration or safety alerts conducted, requested or threatened by any Regulatory Authority with respect to any Product, and no recalls, market withdrawals, field notifications, notifications of misbranding or adulteration or safety alerts have been conducted requested or threatened by any Regulatory Authority relating to any Products. Neither the Borrower nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FDCA or the rules and regulations promulgated thereunder. (f) Neither the Borrower nor any of its Subsidiaries nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (g) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair the Borrower’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as well as the provisions case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets is required in connection with the requirements of Sections 352 and 326 and all other applicable provisions of transactions contemplated hereby, including the USA PATRIOT Act Liens granted in connection herewith and the regulations thereunderexercise of rights and remedies with respect thereto.

Regulatory Matters. (a) Each Sutro acknowledges that Applicable Laws may require that the Product be registered through the imported drug pathway of CZFSthe NMPA, CZFSAC and FCCB has timely filed all reportsSutro or its designated agent, registrations and statementsas the marketing authorization holder in the United States, together with be the marketing authorization or imported drug license holder of the Product in the Field in the Territory. Notwithstanding the foregoing sentence, however, Sutro shall not have any amendments right to Commercialize the Product in the Field in the Territory, which have been granted to Licensee under Section 2.01. In the event Sutro is no longer required under Applicable Laws to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority the marketing authorization or imported drug license holder in the regular course of Territory, then Sutro shall promptly transfer the business of CZFSmarketing authorization or imported drug license to Licensee (and Licensee shall accept such transfer) and shall not require Licensee to make additional payment on such transfer, CZFSAC and/or FCCB, no Governmental Authority has initiated except that Licensee shall promptly reimburse Sutro for any proceeding, and all reasonable expenses ([*]) that Sutro may incur in being and transferring to Licensee the marketing authorization or to imported drug license in the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterTerritory. (b) Other than Subject to the terms and conditions of this Agreement, Licensee will be responsible, at its sole cost and expense, for all regulatory activities leading up to and including the submitting and obtaining of INDs, Regulatory Documentation, Regulatory Approvals, for the Products in the Field in the Territory from Regulatory Authorities in the Territory, provided that, Licensee will conduct such activities (and any and all regulatory activities delegated to Licensee in this Agreement) (1) in its own name, if Licensee is the holder and legal and beneficial owner of the INDs, Regulatory Documentation, and Regulatory Approvals for the Product in the Field in the Territory, or (2) as the express and authorized regulatory agent of record for Sutro in the Field in the Territory (unless a mutually agreed upon CRO has been appointed to perform such function as set forth in CZFS Disclosure Schedule 4.11Section 4.06(d)), since January 1if Sutro is the legal and beneficial owner of the INDs, 2020Regulatory Documentation, CZFS has timely filed with and Regulatory Approvals for the SEC Product in the Field in the Territory, under which situation such actions will be taken on behalf of Sutro and NASDAQ all documents required by for the Securities Act and benefit of Licensee in the Exchange Act and such documents, as Field in the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActTerritory. (c) Neither CZFSLicensee shall use Commercially Reasonable Efforts, FCCB nor any on behalf of their respective properties is a party Sutro (if applicable), to or is subject apply for the Regulatory Approval for the Product in the Territory for all Indications specified in the Development Plan. Licensee shall be responsible for (i) preparing, translating, filing and submitting all Regulatory Documentation related to any Regulatory Order from any Governmental Authority charged the Product with the supervision or regulation of financial institutions or issuers of securities or engaged applicable Regulatory Health Authority(ies) in the insurance Territory, including all applications for Regulatory Approval, at its own cost, (ii) as soon as reasonably practicable, providing to Sutro the English translation of deposits such Regulatory Documentation submitted, to the extent such Regulatory Documentation is not translated from materials provided by Sutro, at its own cost, and (includingiii) providing to Sutro all correspondence with Regulatory Health Authority(ies) in the Territory (each of the foregoing translated in English), without limitationat its own cost. Licensee shall also be responsible for providing, in the format required by the applicable Regulatory Health Authorities, the PADOBS data and information required to be submitted to such Regulatory Health Authorities for Regulatory Approval of the FRB) or Product in the supervision or regulation of it. Neither CZFS nor FCCB has been advised byTerritory, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering including without limitation data from all clinical trials in the appropriateness of issuing or requesting) any Regulatory OrderTerritory. (d) Neither CZFS nor FCCB is As soon as reasonably practicable following the Effective Date, Sutro shall[*] provide to Licensee, all reasonably necessary data and other clinical development information (including manufacturing batch records) pertaining to the Product and Controlled by Sutro, and all necessary certification documents for IND application, BLA equivalent application or Drug Approval Application in the Territory. The technical documents, including but not limited to spectrum and chromatogram derived from Chemistry, Manufacturing, and Controls (CMC) (excluding, for clarity, data pertaining to Expression Technology), preclinical or clinical studies, provided by Sutro shall be in CTD or eCTD format. Upon request by the applicable Regulatory Health Authorities, Sutro shall also provide, if applicable, available specification validation samples and reference standards for the Product. In addition, to the extent necessary for Licensee to obtain Regulatory Approval of a party Product in the Territory, [*]. Notwithstanding the above, if allowed under Applicable Laws, any access by any Regulatory Health Authority to any agreement information relating to Expression Technology shall be provided via (i) a right of reference to a drug master file (or DMF) (or its equivalent in the applicable Region in the Territory) filed by Sutro in the applicable Region in the Territory or (ii) directly to a Regulatory Health Authority by Sutro [*]. (e) Sutro shall use Commercially Reasonable Efforts to attend all meetings or hearings where Sxxxx’s presence is specifically requested by the applicable Regulatory Authority, by telephone, videoconference or (if requested by such Regulatory Authority) in person, provided that Licensee shall [*]. In addition, Sutro acknowledges that the NMPA generally requires applicants to provide responses to its questions and requests within [*], and shall provide Licensee with all reasonable assistance in responding to questions and requests raised by NMPA and other Regulatory Health Authorities within the required timeframe. (f) Licensee shall report to Sutro regarding the status of each pending or proposed IND application, BLA equivalent application or Drug Approval Application covering the Product in the Territory. Licensee shall as soon as reasonably practicable furnish Sutro with English language copies of all substantive correspondence Licensee has had with any individual Regulatory Health Authority, and contact reports concerning substantive conversations or group regarding CRA matters substantive meetings with any Regulatory Health Authority, in each case relating to any such IND, BLA equivalent or Drug Approval Application. (g) Licensee shall be responsible for [*], ensuring the accuracy and neither CZFS nor FCCB has fidelity of the translation, of any Knowledge ofand all documents provided to Regulatory Health Authorities and/or Sutro, nor has CZFS as applicable, under this Section 4.06. (h) Each Party (i) hereby grants to the other Party and its Affiliates a right of reference to all Regulatory Documentation and, Regulatory Approvals Controlled by the first Party and its Affiliates and (ii) will provide to the other Party with access to the Development Data Controlled by the first Party or FCCB been advised its Affiliates, in writing of each case under (i) and (ii) to the extent necessary or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data useful for the year ended December 31Development, 2021Manufacture, filed Commercialization or other exploitation of the Product in the Field in the other Party’s territory, subject in each case to the last sentence of Section 4.06(d). The receiving Party and its Affiliates (A) shall have the right to use such Regulatory Documentation, Regulatory Approvals and Development Data only in connection with the FDICDevelopment, Manufacture, Commercialization or otherwiseother exploitation of the Product in the Field in such Party’s territory, and (B) that any facts or circumstances exist, which would cause CZFS or FCCB: (amay sublicense the rights granted to it under this Section 4.06(h) to be deemed not to be its licensees (in satisfactory compliance with the CRA, and case of Sutro) or Sublicensees (in the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators case of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter XTasly), the USA PATRIOT Actprovided that such licensees or Sublicensees have granted to Sutro and Tasly a reciprocal, and the regulations promulgated thereunder, any order issued sublicensable right with respect to anti-money laundering by the U.S. Department Regulatory Documentation, Regulatory Approvals and Development Data of such licensees and Sublicensees, as applicable. Each Party shall use reasonable efforts to obtain the Treasury’s Office consent of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or its licensees (cin the case of Sutro) and Sublicensees (in the case of Tasly) to be deemed not grant to be in material compliance the other Party and its Affiliates the rights described above with respect to the applicable requirements contained in any federal Regulatory Documentation, Regulatory Approvals and state privacy or data security laws Development Data of such licensees and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunderSublicensees, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderapplicable.

Regulatory Matters. (a) Each of CZFSThe Company and its Subsidiaries are developing, CZFSAC testing, labeling, manufacturing and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authoritystoring, and at all times has paid all fees developed, tested, labeled, manufactured and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course stored each product candidate of the business Company or any of CZFSits Subsidiaries in compliance in all material respects with applicable Law, CZFSAC and/or FCCBincluding the FDA Act and applicable implementing regulations issued by the FDA and any other applicable Governmental Entities, no Governmental Authority has initiated including, as applicable, those requirements relating to the FDA’s current good manufacturing practices, good laboratory practices, good clinical practices and investigational use, in each case, for a new pharmaceutical product. The Company and its Subsidiaries have not received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or to other action from the Knowledge FDA or any other Governmental Entity alleging that any operation or activity of CZFS, investigation into the business Company or operations any of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB its Subsidiaries is “well-capitalized” as defined in violation of the FDA Act or the respective counterparts thereof promulgated by applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterGovernmental Entities outside the United States. (b) Other than The Company and its Subsidiaries have made available to the Buyer complete and correct copies of all governmental authorizations from the FDA, EMA, and all other applicable comparable foreign Governmental Entities (collectively, the “Regulatory Authorities”), held by the Company or any of its Subsidiaries necessary to conduct its business as set forth presently conducted. The Company and its Subsidiaries hold such authorizations the Regulatory Authorities require for the conduct of its business as currently conducted (collectively, the “Regulatory Permits”) and all such Regulatory Permits are in CZFS Disclosure Schedule 4.11full force and effect. The Company and its Subsidiaries have filed all required notices and responses to notices, since January 1supplemental applications, 2020, CZFS has timely filed reports (including all adverse event/experience reports) and other information with the SEC Regulatory Authorities. Each submission to the Investigational New Drug applications submitted by or on behalf of the Company or any of its Subsidiaries to the FDA, including all supplements and NASDAQ amendments thereto was true, complete and correct as of the applicable date of submission. (c) To the Company’s Knowledge, all documents required preclinical studies and clinical trials, and other studies and tests conducted by or on behalf of the Securities Company have been, and if still pending are being, conducted in material compliance, to the extent applicable, with the applicable protocol for such study or trial, good laboratory practices, good clinical practices and all applicable Law, including the FDA Act. No clinical trial conducted by or on behalf of the Company or any its Subsidiaries has been terminated or suspended prior to scheduled completion, and neither the FDA nor any other applicable Governmental Entity, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or on behalf of the Company or any of its Subsidiaries has initiated, or, to the Company’s Knowledge, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of the Company or any of its Subsidiaries. (d) The Company and its Subsidiaries are not subject to any investigation that is pending and of which the Company has been notified in writing or, to the Company’s Knowledge, which has been threatened, in each case by (i) the FDA or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b)), the Federal False Claims Act and the Exchange Act and such documents, (31 U.S.C. §3729) (known as the same may “Federal False Claims Act”) or any equivalent foreign applicable Law. (e) To the Company’s Knowledge, the Company and its Subsidiaries have been amendednot submitted any claim for payment to any government healthcare program in violation of any Laws relating to false claims or fraud, complied, at including the time filed with the SEC, Federal False Claim Act or any applicable state false claim or fraud Law. (f) The Company and its Subsidiaries have complied in all material respects with all applicable security and privacy standards regarding protected health information under (i) the Securities Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, including the Exchange Actregulations promulgated thereunder and (ii) any applicable state privacy Laws. (cg) Neither CZFSTo the Company’s Knowledge, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data all manufacturing operations conducted for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation benefit of the federal Bank Secrecy Act, as amended, Company and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, Subsidiaries have been and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be are being conducted in material compliance with applicable Laws, including, to the applicable requirements contained extent applicable, the provisions of the FDA’s current good manufacturing practice regulations, and the respective counterparts thereof promulgated by Governmental Entities in countries outside the United States. To the Company’s Knowledge, none of the Company’s and its Subsidiaries’ contract manufacturers has received a FDA Form 483 or other Governmental Entity notice of inspectional observations, “warning letters” or “untitled letters”, in each case, related to or affecting any of the Company’s and its Subsidiaries’ products or product candidates. (h) Section 3.17(h) of the Company Disclosure Schedule sets forth a list of (i) all recalls, field notifications, investigator notices, safety alerts, “serious adverse event” reports or other notices of action relating to an alleged lack of safety or regulatory compliance issued by the Company (“Safety Notices”), (ii) the dates such Safety Notices, if any, were resolved or closed, and (iii) to the Company’s Knowledge, any material complaints that are currently unresolved. (i) None of the Company or any of its Subsidiaries has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA or any other Governmental Entity to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or any such similar policies set forth in any federal applicable Laws. None of the Company, its Subsidiaries or, to the Company’s Knowledge, any of their officers, employees or agents, and, in connection with Products, third party suppliers and state privacy contractors, has been convicted of any crime or data security laws and regulationsengaged in any conduct that has resulted, or would reasonably be expected to result, in debarment, disqualification, suspension or exclusion under applicable Law, including, without limitation, 21 U.S.C. Section 335a. To the Company’s Knowledge, no claims, actions, proceedings or investigations that would reasonably be expected to result in Title V such a material debarment or exclusion of the Xxxxx-Xxxxx-Xxxxxx Act Company or any of 1999 and regulations promulgated thereunderits Subsidiaries are pending or threatened against the Company, as well as its Subsidiaries or any of their officers, employees or agents. (j) The Company has made available to the provisions Buyer all material written formal communications submitted by or on behalf of the information security program adopted by CZFS pursuant Company or any of its Subsidiaries to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderRegulatory Authority.

Regulatory Matters. (a) Each of CZFSCustomer shall, CZFSAC at its expense, obtain and FCCB has timely filed maintain all reportspermits, registrations licenses, clearances and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, approvals from the FDA and has paid all fees and assessments due and payable in connection therewith. Except other regulatory agencies as are necessary or appropriate for normal examinations conducted by any Governmental Authority in the regular course distribution of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterProducts. (b) Other than Each Party will notify the other Party promptly upon receipt of information indicating that any of the Products may be subject to a recall, field corrective action or other regulatory action with respect to a Product taken either by virtue of applicable federal, state, foreign or other law or regulation or good business judgment (a “Remedial Action”). Customer shall be responsible for determining the necessity of conducting any Remedial Action and WuXi AppTec shall cooperate in gathering and evaluating such information as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with is reasonably necessary for Customer to make such determination. In the SEC and NASDAQ all documents event Customer determines that a Remedial Action should be commenced or a Remedial Action is required by any governmental authority Exhibit 10.68 having jurisdiction over the Securities Act matter, Customer shall be responsible for the control and coordination of all efforts necessary to conduct such Remedial Action and shall keep WuXi AppTec reasonably informed regarding the Exchange Act status of such Remedial Action. [*] shall be responsible for the cost and such documents, as expense of the same may have been amended, complied, at Remedial Action unless the time filed with the SECRemedial Action results from [*], in all material respects with which case [*] shall be responsible and shall reimburse [*] for the Securities Act cost and the Exchange Actexpense of such Remedial Action. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged Each Party will comply with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act Adverse Reaction Reporting systems, including the requirements of 21 CFR Part 1270, and each Party will cooperate with the regulations thereunderother Party for the efficient compliance therewith. WuXi AppTec agrees to notify Customer promptly upon receipt from any customer of any complaint or Adverse Reaction Report relating to the Products. Customer shall investigate and WuXi AppTec shall reasonably cooperate in any investigation of such complaint or Adverse Reaction Report and Customer will keep WuXi AppTec reasonably informed regarding the findings from such investigation.

Regulatory Matters. (a) Each of CZFSFrom and after the Effective Time, CZFSAC Buyer, at its cost, shall be solely responsible and FCCB has timely filed liable for (i) taking all reportsactions, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid paying all fees and assessments due conducting all communication with the appropriate Governmental or Regulatory Authority required by Law in respect of the Product Regulatory Approvals, including preparing and payable in connection therewith. Except for normal examinations conducted by filing all reports (including adverse drug experience reports and product deviation reports) with the appropriate Governmental or Regulatory Authority (whether Infergen is sold before or after transfer of such Product Regulatory Approval) and shall indemnify and hold harmless Seller against any Governmental Authority damages resulting from preparation, calculation or filing (or failure to file) such reports (provided Seller cooperates with Buyer as is reasonably necessary in the regular course filing and preparation of the business of CZFSsuch reports), CZFSAC and/or FCCB(ii) except as expressly set forth in Section 5.15, no Governmental Authority has initiated any proceedingsubmitting all applications for marketing authorizations, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulationswhere such authorizations have not yet been granted, and FCCB has a Community Reinvestment Act rating variation of “satisfactory” existing authorizations, (iii) taking all actions and conducting all communication with third parties in respect of Infergen sold pursuant to such Product Regulatory Approval (whether sold before or betterafter transfer of such Product Regulatory Approval), including responding to all complaints in respect thereof, including complaints related to tampering, counterfeiting or contamination, and (iv) investigating all complaints and adverse drug experiences in respect of Infergen sold pursuant to such Product Regulatory Approval (whether sold before or after transfer of such Product Regulatory Approval). (b) Other than as set forth From and after the Effective Time, Seller shall notify Buyer within three (3) Business Days (or sooner if required by Law) if Seller receives a complaint or a report of a life threatening serious adverse drug experience (a “Life Threatening SAE”) in CZFS Disclosure Schedule 4.11respect of Infergen and within ten (10) Business Days (or sooner if required by Law) if Seller receives a complaint or a report of a non-life threatening serious adverse drug experience in respect of Infergen (a “Non-Life Threatening SAE” and together with a Life Threatening SAE, since January 1an “SAE”). In addition, 2020, CZFS has timely filed Seller shall prepare and send quarterly reports to Buyer of any other adverse drug experience in respect to Infergen which is not an SAE and Seller shall cooperate with Buyer’s reasonable requests and use commercially reasonable efforts to assist Buyer in connection with the SEC investigation of and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject response to any Regulatory Order from any Governmental Authority charged with the supervision SAE or regulation of financial institutions other complaint or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise adverse drug experience related to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderInfergen sold by Seller. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.

Regulatory Matters. (a) Each of CZFS, CZFSAC DS shall furnish ARQULE with efficacy and FCCB has timely filed all reports, registrations and statements, together with any amendments required safety information reasonably requested by ARQULE to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable assist ARQULE in connection therewith. Except for normal examinations conducted by any Governmental Authority promoting the Co-Commercialized Licensed Product in the regular course United States, including without limitation relevant clinical and safety data included in the NDA for the Co-Commercialized Licensed Product and additional information, if any, related to the efficacy and safety profile of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “wellCo-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterCommercialized Licensed Product. (b) Other than as set forth DS and ARQULE will have joint responsibility for and will make all decisions with respect to any recall, market withdrawal, or any other corrective action related to the Co-Commercialized Licensed Product in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed the United States. DS will notify and consult with ARQULE prior to implementation of any such actions that are reasonably likely to result in a material adverse effect on the marketability of the Co-Commercialized Licensed Product in the United States and shall consider in good faith any comments ARQULE may have with respect to such implementation. DS and ARQULE will be jointly responsible for interactions with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and FDA or other Regulatory Authorities with regard to such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actcorrective action. (c) Neither CZFSIn accordance with Section 3.10.3(c), FCCB nor any the Parties shall exercise Commercially Reasonable Efforts to execute a mutually satisfactory pharmacovigilance agreement for the Territory (the “Pharmacovigilance Agreement”) at least ninety (90) days prior to the date of their respective properties is a party to or is subject to any Commercialization Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged Approval in the insurance of deposits (includingUnited States. The Pharmacovigilance Agreement shall provide for, without limitationbut not be limited to, the PADOBS exchange of (i) drug safety information; (ii) Co-Commercialized Licensed Product defect information; (iii) reporting data regarding lack of efficacy; (iv) International Conference on Harmonisation (ICH) seven (7) and fifteen (15) day reports; (v) the FRBcreation and maintenance of a master drug safety database; (vi) or evaluations derived from drug safety data; and (vii) such other information and data as may be reasonably agreed upon by the supervision or regulation of itparties. Neither CZFS nor FCCB has been advised byDS will be solely responsible for submitting, or has any Knowledge of facts which could give rise recording and storing all data to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any FDA and other appropriate Regulatory OrderAuthorities. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters DS will be solely responsible for submitting, recording and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and storing all other applicable provisions of the USA PATRIOT Act and the regulations thereunderFDA 2253 submissions.

Regulatory Matters. (a) Each of CZFSPromptly after the Termination Agreement Date, CZFSAC and FCCB has timely filed all reports, registrations and statements, together in accordance with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as timelines set forth in CZFS Disclosure Schedule 4.11Exhibit A, since January 1Takeda shall, 2020in consultation with AMAG and as further described below, CZFS has timely prepare all Regulatory Materials that are necessary to be filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party Regulatory Authority to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting transfer (or is considering Withdraw pursuant to Section 5.6 or Exhibit A) the appropriateness marketing authorization in each Terminated Territory to AMAG. In connection with such activities, Takeda shall provide AMAG with draft submissions of issuing Regulatory Materials, sufficiently in [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. advance of filing to allow AMAG to review and comment on such drafts, and AMAG shall respond in a timely manner, and shall consider in good faith all reasonable comments of AMAG prior to filing the applicable Regulatory Materials. Takeda shall promptly provide AMAG with copies of all communications received from a Regulatory Authority in connection with such transfers, and will notify AMAG within one (1) business day of receipt of approval and effectiveness of the transfer or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing Withdrawal of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed each marketing authorization. Takeda undertakes not to be provide any response to communications from a Regulatory Authority in satisfactory compliance relation to transfer or Withdrawal of each marketing authorization without first consulting with the CRA, and the regulations promulgated thereunder, or AMAG for AMAG’s comments concerning such response. Each Party shall bear all expenses it incurs to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and conduct its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderactivities under this Section 3.1.

Regulatory Matters. (a) Each Sellers have all material Permits required by the FDA and any other Governmental Authority that regulates the manufacture, sale or distribution of CZFSthe Products to conduct the Business (the “FDA Permits”). All of the FDA Permits are in full force and effect, CZFSAC the holder of such permit is in compliance in all material respects with, and FCCB is not in material default under (and to the Knowledge of Sellers, no event which with the giving of notice or lapse of time, or both, would become a material default under), each such FDA Permit, and to the Knowledge of Sellers none of such Permits shall be terminated or impaired or become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement and the other Transaction Documents. To the Knowledge of Sellers, no written notice of cancellation, default or any dispute concerning any FDA Permit has timely filed been received by the Seller or any of its Affiliates. Sellers are the sole and exclusive owners of the FDA Permits and the associated filings and applications with the FDA or any other Governmental Authority, including any BLA, NDA, 510(k) submission, premarket approval, IND or investigational device exemption application, comparable regulatory application or filing made or held by or issued to a Seller or any of its Affiliates (collectively, the “Seller Regulatory Filings”) and hold all reportsright, registrations title and statementsinterest in and to all Seller Regulatory Filings free and clear of any Lien (other than Permitted Liens). No Seller or any of its Affiliates has granted any third party any right or license to use, together access or reference any of the Seller Regulatory Filings, including any of the Know-How contained in any of the Seller Regulatory Filings or rights (including any regulatory exclusivities) associated with any amendments required to be made with respect thereto, that it was required to file since each such Seller Regulatory Filing. (b) Since January 1, 2020 2009, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any Product. (c) With respect to the Products, each Seller and each of its Affiliates is in compliance in all material respects with all Applicable Laws and any other letters, notices or guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no regulatory Actions pending (to the Knowledge of Sellers with respect to audits and investigations) and, to the Knowledge of Sellers, there are no regulatory Actions threatened (in each case, other than non-material routine or periodic inspections) pertaining to any Product against any Person (each, a “Collaborative Partner”) that manufactures any component, ingredient, or material used in manufacturing the Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with a Seller or any of its Affiliates by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 2009 there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted Applicable Law with respect to the Products or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority in the regular course with regard to any Product. (d) The manufacture of the business of CZFSProducts by the Sellers or their Affiliates and, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFSthe Sellers, investigation into the business or operations of CZFS, CZFSAC and/or FCCBby third parties has, since January 1, 2020. FCCB 2009, been and is being conducted in compliance in all material respects with current “well-capitalizedgood manufacturing practices,” as defined in applicable laws and regulationsby the FDA, and FCCB has a Community Reinvestment Act rating of including, as applicable, the FDA’s “satisfactoryQuality System Regulation” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.1121 C.F.R. Part 820 and 21 C.F.R. Parts 211, 600 & 820. The sale of Products with Regulatory Approvals by Healthpoint or any of its Affiliates has, since January 1, 20202009, CZFS been and is being conducted in all material respects in accordance with those Regulatory Approvals and without unlawful promotion of “off-label” or other prohibited uses. (e) Each Seller and its Affiliates are and since January 1, 2009 have been with respect to the Business in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDR Reportable Events (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions. (f) No Seller, any of its Affiliates or, to the Knowledge of Sellers, any of their respective Collaborative Partners, agents or subcontractors with respect to the Business (i) has timely filed been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority or (ii) has failed to disclose a material fact required to be disclosed to any Governmental Authority with respect to the Purchased Assets, and there are no proceedings pending or, to the Knowledge of Sellers, threatened that would reasonably be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. No Seller, its Affiliates or, to the Knowledge of Sellers, any of their respective Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy. (g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the SEC use (including in clinical trials) of any Product that have not been reported to the FDA or any other Governmental Authority in accordance with Applicable Law. Prior to the date hereof, Seller Parent has made available to Buyer Domestic (i) a schedule of all payouts made by a Seller or any of its Affiliates to end-users since January 1, 2009 in respect of claims relating to any Product and NASDAQ (ii) a schedule of all documents required actual or threatened (in writing) claims made by end-users against a Seller or any of its Affiliates relating to a Product since January 1, 2009. (h) All studies, tests, and preclinical and clinical research being conducted by a Seller, any of its Affiliates, and to the Knowledge of Sellers, on behalf of a Seller or any of its Affiliates by any of their respective Collaborative Partners, with respect to any Product, are being, and at all times have been, conducted in compliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the Securities FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Applicable Laws of any other Governmental Authority. No clinical trial conducted by a Seller or any of its Affiliates or, to the Exchange Knowledge of Sellers, on behalf of a Seller or any of its Affiliates, with respect to any Product has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated or, to the Knowledge of Sellers, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or Person involved in any such clinical trial. (i) No Seller, any of its Affiliates or any of their respective officers, directors, managing employees (as those terms are defined in 42 C.F.R. § 1001.1001), nor, to the Knowledge of Sellers, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of a Seller or any of its Affiliates is a party to or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Applicable Laws governing any Federal Healthcare Program with respect to any Product, and, to the Knowledge of Sellers, no such agreement is threatened in writing. (j) No Seller, any of its Affiliates, nor any of their respective officers, directors, managing employees (as those terms are defined in 42 C.F.R. § 1001.1001), nor, to the Knowledge of Sellers, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of a Seller or any of its Affiliates: (i) has been debarred, excluded or suspended from participation in any Federal Healthcare Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 40, Xxxxxxx 0, xx xxx Xxxxxx Xxxxxx Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and such documentsnon-procurement programs; (iv) to the Knowledge of Sellers, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Healthcare Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Healthcare Program. (k) There are no filings of an Action pending and, to the Knowledge of Sellers, there are no filings of an Action threatened against a Seller or any of its Affiliates relating to the Business or any Product under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (l) To the Knowledge of Sellers, no Seller or any of its Affiliates is under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the same may Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Applicable Laws. No Seller or any of its Affiliates is a “covered entity” as that term is defined in HIPAA. Each Seller and its Affiliates have been amendedin compliance in all material respects with federal and state data breach Applicable Laws. (m) To the extent a Seller provides reimbursement coding or billing advice regarding any Product or procedures related thereto, complied, at the time filed with the SEC, such advice is and has been true and complete in all material respects and in compliance in all material respects with the Securities Act payment requirements of Medicare and the Exchange Actother Applicable Laws governing a Federal Healthcare Program. (cn) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, Each Seller and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued Affiliates have at all times complied in all material respect with Applicable Laws with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) Business relating to be deemed not to be in material compliance with the applicable requirements contained in any federal security and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderstandards regarding protected health information.

Regulatory Matters. (a) Each If ACADIA receives any written material or oral communication from any relevant regulatory agencies or other governmental entities relating to commercialization of CZFSProduct in the United States in the Field, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required then ACADIA shall provide a copy of such written or oral communication to the Distributor within […***…] business days after receipt. If BLS or the Distributor receives what they consider to be made with respect thereto, that it was required significant written material or oral communication from any relevant regulatory agencies or other governmental entities relating to file since January 1, 2020 with any Governmental AuthorityProduct, and has paid all fees such written or oral communications would be relevant to professional presentations related to Product or any of ACADIA’s activities or responsibilities under the Co-Promotion Agreement, then BLS or the Distributor, as applicable, shall provide a copy of any such written or oral communication to ACADIA within […***…] Business Days after 12. ***Confidential Treatment Requested receipt. Additionally, each of ACADIA and assessments due and payable in connection therewith. Except for normal examinations conducted BLS or the Distributor, as applicable, shall, as soon as reasonably practicable, provide a copy (electronically if practicable) to the other of any regulatory submission or other substantive written material sent by ACADIA, BLS or the Distributor, or substantive oral communication made by ACADIA, BLS or the Distributor, to any Governmental Authority relevant regulatory agency or other governmental entities relating to commercialization of Product in the regular course of Field in the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterUnited States. (b) Other than ACADIA shall not, without the prior written consent of BLS or the Distributor, as set forth in CZFS Disclosure Schedule 4.11applicable, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents or unless so required by Applicable Laws correspond or communicate with any other Regulatory Authority, concerning Product or otherwise take any action concerning any authorization or permission under which Product are sold or any application for the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actsame. (c) Neither CZFS, FCCB nor any of their respective properties If ACADIA is a party to or is subject to advised by its counsel that it must communicate with any Regulatory Order from any Governmental Authority charged with concerning Product, then ACADIA shall so advise BLS or the supervision or regulation of financial institutions or issuers of securities or engaged in Distributor, as applicable, immediately and, unless the insurance of deposits (includingApplicable Laws prohibits, without limitation, the PADOBS provide BLS and the FRB) or the supervision or regulation Distributor in advance with a copy of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) proposed written communication with any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement Authority and comply with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation all reasonable direction of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, Distributor concerning any order issued meeting or written or oral communication with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersuch Regulatory Authority.

Regulatory Matters. Except as disclosed in Section 3.27 of the EMERALD DISCLOSURE SCHEDULE and except to the extent EMERALD is under special supervision as a state savings bank formed under Ohio law within the last three years, (a) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental AuthorityEMERALD is not subject to, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted not been advised by any Governmental Authority in the regular course FDIC or by the DIVISION that it is likely to become subject to, a written order, decree, agreement, memorandum of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceedingunderstanding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed similar agreement with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) FDIC or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”DIVISION; (b) EMERALD has not entered into a commitment letter with or received an extraordinary supervisory letter from the FDIC or the DIVISION having to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, do with safety and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, soundness or with compliance issues; and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed EMERALD’s Board of Directors has not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective requested by the FDIC or the DIVISION to adopt any extraordinary resolutions having to do with safety and soundness or with compliance issues. EMERALD has provided MBCN with, or given MBCN access to, all agreements, understandings, and commitments with and all orders and directives of all government regulatory agencies or authorities concerning the financial condition, results of operations, business, assets, or capital of EMERALD that currently are binding upon or that require action by, or that at any time during the last three years have been binding upon or have required action by, EMERALD, including without limitation all written correspondence, written communications, and written commitments related thereto. All such agreements, understandings, commitments, orders, directives, correspondence, and written communications that currently are binding upon or that require action by, or that at any time during the last three years have been binding upon or have required action by, EMERALD are set forth in the EMERALD DISCLOSURE SCHEDULE. There are no refunds or restitutions required to be paid as a result of any criticism of any regulatory agency or body cited in any examination report of EMERALD as a result of an examination by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderregulatory agency or body, or set forth in any accountant’s or auditor’s report to EMERALD.

Regulatory Matters. (a) Each Except as set forth on Part 2.6(a) of CZFSthe Disclosure Schedule, CZFSAC and FCCB each of the Specified Products is being or has timely filed all reportsbeen developed, registrations and statementsmanufactured, together with any amendments required to be made with respect theretotested, that it was required to file since January 1packaged, 2020 with any Governmental Authoritydistributed, and sold in substantial compliance with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FDCA”), the Public Health Service Act (“PHSA”) and the regulations of the Food and Drug Administration (“FDA”) promulgated thereunder and similar applicable foreign Legal Requirements, including those relating to investigational use, good manufacturing practices, good clinical practices, good laboratory practices, registration and listing, record keeping, adverse event reporting, and submission of other required reports. The Specified Authorizations are current and in full force and effect and include all necessary and relevant regulatory filings and governmental registrations made by or issued to Seller or any of its Affiliates that relate specifically to the Specified Products. Seller has paid made available to Purchaser true and complete copies of all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority governmental correspondence (including copies of official notices, citations or decisions) in the regular course files of Seller or the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or Specified Affiliates relating to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterSpecified Authorizations. (b) Other than Except as set forth on Part 2.6(b) of the Disclosure Schedule, Seller or the Specified Affiliates have obtained all necessary licenses, permits and registrations required by FDA, any other applicable Governmental Entity, and any applicable foreign regulatory authority to permit the operation of the Specified Business by Seller and the Specified Affiliates as presently conducted and all such licenses, permits and registrations are included in CZFS Disclosure Schedule 4.11the Specified Authorizations. Neither Seller nor any of its Affiliates have received any communication from any Governmental Entity threatening to withdraw or suspend any such license, since January 1permit, 2020, CZFS has timely or registration. Seller or the Specified Affiliates have filed with the SEC applicable regulatory authorities all required filings, declarations, listings, registrations, reports or submissions, including adverse event reports. All relevant filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Legal Requirements when filed, and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may no deficiencies have been amendedasserted by any applicable regulatory authority with respect to any such filings, complieddeclarations, at the time filed with the SEClisting, in all material respects with the Securities Act and the Exchange Actregistrations, reports or submissions. (c) Neither CZFS, FCCB Seller nor any of their respective properties its Affiliates nor, to the Knowledge of Seller, any of the officers, key employees, agents or clinical investigators acting for Seller or any of its Affiliates has received any communication from FDA or any other Governmental Entity, including without limitation any warning letter or untitled letter that alleges or suggests that the Specified Business is a party to or is subject to not in compliance with any Regulatory Order from any Governmental Authority charged with applicable requirements under the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitationFDCA, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised byPHSA, FDA regulations promulgated thereunder, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordersimilar applicable foreign Legal Requirements. (d) Neither CZFS nor FCCB is Seller or any of the Specified Affiliates nor, to the Knowledge of Seller, any of the officers, key employees, agents or clinical investigators acting for Seller or the Specified Affiliates, has committed any act, made any statement or failed to make any statement or commit any act that would reasonably be expected to provide a party basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any agreement with any individual amendments thereto. Additionally, neither Seller or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofthe Specified Affiliates, nor to the Knowledge of Seller, any officer, employee or agent of Seller or the Specified Affiliates has CZFS been convicted of any crime or FCCB been advised engaged in writing of any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any reason similar state Legal Requirement; or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state Legal Requirement. (e) Except as set forth in Part 2.6(e) of the Disclosure Schedule, to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31Knowledge of Seller, 2021there are no investigations, filed with suits, claims, actions or proceedings against or affecting Seller or any Specified Affiliate relating to the FDICSpecified Products, including those relating to or arising under applicable Legal Requirements relating to government health care programs, private health care plans, or otherwisethe privacy and confidentiality of patient health information. (f) that Seller and the Specified Affiliates are in compliance in all material respects with all healthcare Legal Requirements to the extent applicable to the operation of the Specified Business and the sale of the Specified Products, as currently conducted, including any facts or circumstances existand all federal, which would cause CZFS or FCCB: state and local fraud and abuse laws, including the federal Anti-Kickback Statute (a42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunderpursuant to such statutes. Neither Seller nor any Specified Affiliate is subject to any enforcement, regulatory or administrative proceedings against or affecting Seller relating to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of or arising under the federal Bank Secrecy Act, as amendedFDCA or similar Legal Requirement, and its implementing regulations (31 C.F.R. Chapter X)to the Knowledge of Seller no such enforcement, the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, regulatory or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board administrative proceeding has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderthreatened.

Regulatory Matters. (a) Each Diffusion has no Knowledge of CZFSany actual or threatened enforcement action by the FDA or any other Governmental Entity which has jurisdiction over the operations of Diffusion, CZFSAC and, since the Reference Date, has not received notice of any pending or overtly threatened claim by the FDA or any other Governmental Entity which has jurisdiction over the operations of Diffusion against Diffusion, and FCCB Diffusion has timely filed all reports, registrations and statements, together with any amendments required no Knowledge of or reason to be made with respect thereto, believe that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB Entity is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterconsidering such an action. (b) Other than as set forth in CZFS Disclosure Schedule 4.11Since the Reference Date, since January 1all material reports, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as claims and notices required to be filed, maintained, or furnished to the same may FDA or any other Governmental Entity by Diffusion have been amendedso filed, compliedmaintained or furnished. All such reports, at the time filed with the SECdocuments, claims, and notices were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing prior to the date hereof) such that no material liability exists with respect to the Securities Act and completeness or accuracy of such filing. All fees required to be paid to the Exchange ActFDA by Diffusion have been timely paid in full. (c) Neither CZFSExcept as set forth on Section 4.22(c) of the Diffusion Disclosure Schedule, FCCB nor Diffusion has not received any of their respective properties is a party FDA Form 483, Warning Letter, untitled letter or other correspondence or notice from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Permits, and Diffusion has no knowledge or reason to believe that the FDA or is subject to any Regulatory Order from any other Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or Entity is considering the appropriateness of issuing or requesting) any Regulatory Ordersuch an action. (d) Neither CZFS nor FCCB is a party All studies, tests and preclinical and clinical trials being conducted by Diffusion have been and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and applicable Laws, rules, regulations and guidance, including, but not limited to the applicable requirements of Good Laboratory Practices or Good Clinical Practices, as applicable. To the Knowledge of Diffusion, there are no studies, tests or trials the results of which materially call into question the clinical results described or referred to in the Confidential Offering Memorandum, dated May 15, 2014, delivered to potential investors in connection with Diffusion’s series E convertible note offering, when viewed in the context in which such results are described and the clinical state of development. Diffusion has not received any agreement with written notices, correspondence or other communication from the FDA or any individual other Governmental Entity since the Reference Date, requiring the termination, suspension or group regarding CRA matters and neither CZFS nor FCCB has material modification of any Knowledge ongoing or planned clinical trials conducted by, or on behalf of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDICDiffusion, or otherwisein which Diffusion has participated, and Diffusion has no Knowledge that the FDA or any other Governmental Entity will take such action. (e) that any facts Since the Reference Date, the manufacture of products by or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be on behalf of Diffusion has been and is being conducted in satisfactory material compliance with all applicable Laws including the CRAFDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices. In addition, since the Reference Date, Diffusion has been and is in material compliance with all other applicable FDA requirements, including, but not limited to, registration and listing requirements set forth in 21 U.S.C. Section 360 and 21 C.F.R. Part 207 and 807. (f) Diffusion is and at all times since the Reference Date has been in material compliance with federal or state criminal or civil Laws (including without limitation the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), Xxxxx Law (42 U.S.C. §1395nn), False Claims Act (31 X.X.X. §0000 et seq.), Health Insurance Portability and Accountability Act of 1996 (Pub. L. No. 104-191), the Veterans Health Care Act of 1992, and any comparable state Laws), or the regulations promulgated thereunderpursuant to such Laws, or which are cause for civil penalties or mandatory or permissive exclusion from any Program. There is no civil, criminal, administrative or other action, suit, demand, claim, hearing, proceeding, notice or demand pending, received by or, to the Knowledge of Diffusion, overtly threatened against Diffusion which could reasonably result in its exclusion from participation in any Program or other third-party payment programs in which Diffusion participates. (g) Neither Diffusion nor, to the Knowledge of Diffusion, any of its officers, employees, agents or clinical investigators has committed any act, made any statement or failed to make any statement that would reasonably be assigned expected to provide a rating basis for CRA purposes the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of Diffusion or, to the Knowledge of Diffusion, any of its officers, employees, or agents has been convicted of any (i) debarment under 21 U.S.C. Section 335a or any similar Law or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law. (h) Diffusion is not subject to any pending or, to the Knowledge of Diffusion, threatened investigation by Bank Regulators the FDA, the United States Department of lower than “satisfactory”; (b) Health and Human Services’ Office of Inspector General, or the United States Department of Justice pursuant to be deemed to be operating in material violation of the federal Bank Secrecy Anti-Kickback Statute, the False Claims Act, the Federal Food, Drug and Cosmetic Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statuteLaw, rule including without limitation any equivalent or regulation; similar statute or (c) to be deemed not to be in material compliance with the applicable requirements contained in regulation of any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any foreign regulatory or Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderEntities.

Regulatory Matters. (a) Each Meadow and each of CZFSits Subsidiaries are, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 have been, in compliance in all respects with all applicable Laws, including the FDCA and any other similar Laws administered or promulgated by the FDA or other comparable Governmental AuthorityEntity, except for any noncompliance which would not have a Meadow Material Adverse Effect. Without limiting the foregoing, all Meadow Products have been manufactured, packaged, labeled, tested, stored, shipped, handled, warehoused, and has paid distributed in accordance with all fees applicable Laws and assessments due Meadow Permits (as defined below), commensurate with the Meadow Products’ stage of development, and payable in connection therewithare not and have not been adulterated, misbranded, or prohibited from introduction into interstate commerce under applicable Law. Except for normal examinations conducted To Meadow’s Knowledge, as of the date hereof, no investigation, inspection, claim, suit, proceeding, audit or other action by any Governmental Authority in the regular course Entity is pending or threatened against Meadow or any of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterits Subsidiaries. (b) Other than There is no agreement, judgment, injunction, order or decree binding upon Meadow or any of its Subsidiaries which (i) has or would reasonably be expected to have the effect of prohibiting or materially impairing any material business practice of Meadow or any of its Subsidiaries, any acquisition of material property by Meadow or any of its Subsidiaries or the conduct of any material portion of the business by Meadow or any of its Subsidiaries as set forth in CZFS Disclosure Schedule 4.11currently conducted, (ii) is reasonably likely to have a material adverse effect on Xxxxxx’s ability to comply with or perform any covenant or obligation under this Agreement, or (iii) is reasonably likely to have the effect of preventing, materially delaying, making illegal or otherwise materially interfering with the Contemplated Transactions. (c) Meadow and its Subsidiaries have at all times since January 1, 20202020 held and have operated in compliance with all Governmental Authorizations that are necessary for the conduct of the business of Meadow and its Subsidiaries as currently being conducted (the “Meadow Permits”), CZFS has except where such failures to hold or remain so in compliance would not have a Meadow Material Adverse Effect. All such Meadow Permits are valid and are in full force and effect, and assuming the notices, filings or other Consents listed on Section 4.16(c) of the Meadow Disclosure Schedule have been made or obtained, will continue to be so upon consummation of the Contemplated Transactions, except as would not have a Meadow Material Adverse Effect. (d) Section 4.16(d) of the Meadow Disclosure Schedule identifies each Meadow Permit. Meadow and its Subsidiaries hold all right, title and interest in and to all the Meadow Permits free and clear of any Lien. All fees and charges with respect to such Meadow Permits, as of the date hereof, have been paid in full and all filing, reporting and maintenance obligations have been completely and timely filed satisfied, except as would not have a Meadow Material Adverse Effect. Meadow and each of its Subsidiaries are in material compliance with the SEC terms of the Meadow Permits. To Meadow’s Knowledge, as of the date hereof no Legal Proceeding is pending or threatened, which seeks to revoke, limit, suspend, or materially modify any Meadow Permit. (e) To Meadow’s Knowledge, as of the date hereof there are no proceedings pending or threatened with respect to an alleged material violation by Meadow or any of its Subsidiaries of the FDCA or any other similar Law administered or promulgated by any comparable Governmental Entity. As of the date hereof, neither Meadow, any of its Subsidiaries nor to Meadow’s Knowledge, any Person providing services to Meadow or any of its Subsidiaries with respect to Meadow’s product candidates zandelisib, voruciclib or ME-344 and NASDAQ currently contemplated uses (the “Meadow Products”) has received any written notice, including any warning letter, untitled letter, cyber letter, FDA Form-483, Establishment Inspection Report, written notice of other adverse finding, notice of integrity review, notice of investigation, request for corrective or remedial action, or notice of deficiency or violation, or similar written communication from the FDA or any other Governmental Entity alleging that Meadow or its Subsidiaries, their respective operations, or the Meadow Products are in material violation of any applicable Law or Meadow Permits. (f) No Meadow Product has been or has been requested by a Governmental Authority or other Person to be recalled, withdrawn, removed, suspended, seized, the subject of a corrective action, or discontinued (whether voluntarily or otherwise). Neither Meadow, nor, to Meadow’s Knowledge, any Governmental Authority or other Person, has sought, is seeking, or, to Meadow’s Knowledge, has or is currently threatening or contemplating any Recall of a Meadow Product. (g) As required under applicable Law or pursuant to a Governmental Authorization, Meadow and its Subsidiaries have maintained, filed, or furnished to the applicable Governmental Entities or Person all documents required by the Securities Act and the Exchange Act and such filings, documents, as claims, reports, notices, and other submissions (the same may have been amended“Meadow Reports”), compliedrequired to be maintained, filed, or furnished on a timely basis, and, at the time filed with of maintenance, filing, or furnishing all such Meadow Reports were complete and accurate when submitted, or were subsequently updated, changed, corrected, or modified, except where the SECfailures to so maintain, file, furnish, update, change, correct or modify would not have a Meadow Material Adverse Effect. (h) Neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries has made an untrue statement of a material fact or fraudulent statement to the FDA or a Governmental Entity, failed to disclose a material fact required to be disclosed to the FDA or a Governmental Entity, or made a statement, or failed to make a statement that, would reasonably be expected to provide a basis for the FDA to invoke the FDA Ethics Policy. Neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries has ever been investigated by the FDA or other Governmental Entity for data or healthcare program fraud. Neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries is the subject of any pending or, to Meadow’s Knowledge, threatened investigation pursuant to the FDA Ethics Policy, or resulting from any other untrue or false statement or omission. (i) As of the date hereof, neither Meadow, its Subsidiaries, nor any Person providing services to Meadow or its Subsidiaries, nor their respective officers, directors, partners, employees, or agents have been: (i) debarred or suspended pursuant to 21 U.S.C. § 335a; (ii) excluded under 42 U.S.C. § 1320a-7 or any similar law, rule or regulation of any Governmental Entity; (iii) excluded, debarred, suspended or deemed ineligible to participate in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration; (iv) charged, named in a complaint, convicted, or otherwise found liable in any Legal Proceeding that falls within the ambit of 21 U.S.C. § 331, 21 U.S.C. § 333, 21 U.S.C. § 334, 21 U.S.C. § 000x, 00 X.X.X. § 000x, 00 X.X.X. § 0000x—7, 31 U.S.C. §§ 3729 – 3733, 42 U.S.C. § 1320a-7a, or any other applicable Law; (v) disqualified or deemed ineligible pursuant to 21 C.F.R. Parts 312, 511, or 812, or otherwise restricted, in whole or in part, or subject to an assurance; or (vi) had a pending Legal Proceeding, or otherwise received any written notice from any Governmental Entity or any Person threatening, investigating, or pursuing (i)-(v) above. (j) Meadow has not been restrained by a Governmental Authority nor other Person in its ability to conduct or have conducted the manufacturing, operation, storage, import, export, distribution, warehousing, packaging, labeling, handling, shipping, and/or nonclinical, clinical, or other testing of the Meadow Products. (k) All clinical, pre-clinical and other studies and tests conducted by or on behalf of, or sponsored by, Meadow or any of its Subsidiaries, or in which Meadow or any of its Subsidiaries or the Meadow Products have participated, were and, if still pending, are being conducted in compliance in all material respects with all applicable Laws and regulations enforced by the Securities Act FDA or any comparable Governmental Entity, including, to the extent applicable, 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812. The study reports, protocols, and statistical analysis plans for all such studies and tests accurately, completely, and fairly reflect the Exchange Actresults from such studies and tests. Xxxxxx has not received written notice of any complaints, information, or adverse drug experience reports related to a Meadow Product that would have a Meadow Material Adverse Effect. (cl) Neither CZFSAs of the date hereof, FCCB neither Meadow, its Subsidiaries, nor to Meadow’s Knowledge, any Person providing services to Meadow or its Subsidiaries has received any written notice, correspondence, or other written communications from the FDA, any other Governmental Entity, any IRB or other Person or board, such as, but not limited to, a data safety monitoring board, responsible for the oversight of the conduct of any study conducted by or on behalf of, or sponsored by, Meadow or any of their respective properties its Subsidiaries, or in which Meadow or any of the Meadow Products are participating, requiring or threatening the termination, hold, material adverse modification or suspension of any clinical study that is a party to being or is subject proposed to any Regulatory Order from any Governmental Authority charged be conducted. All clinical studies conducted or sponsored by or on behalf of Meadow or its Subsidiaries were and, if still pending, are being conducted in all material respects in accordance with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitationall applicable Laws, the PADOBS protocols, procedures and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bycontrols designed and approved for such studies, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement and in accordance with any individual requirement of an IRB or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS other Person or FCCB been advised in writing board responsible for review or oversight of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersuch studies.

Regulatory Matters. (a) Each Seller shall obtain and maintain all Regulatory Approvals and other permits and licenses that are necessary for Seller to Manufacture the Product for sale to Buyer in accordance with the terms of CZFS, CZFSAC this Agreement and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterApplicable Law. (b) Other than as set forth Buyer shall be responsible during the Term to obtain and maintain all Regulatory Approval necessary to market, distribute and sell the Product in CZFS Disclosure Schedule 4.11the Territory in accordance with Applicable Law. Buyer agrees to distribute and sell any Product Manufactured and supplied pursuant to a Purchase Order under this Agreement using only a Buyer (or its Affiliate’s) NDC number. As appropriate, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, Seller or Seller’s designated supplier shall be listed as the same may have been amendedmanufacturer on the Label for the Product. Buyer shall be solely responsible for communications and filings with and submissions to any regulatory agency concerning sales of Product, compliedprices, at discounts, rebates, fees, charge-backs, and other payments associated with Buyer’s distribution and sale of the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActProduct. (c) Neither CZFSDuring the Term, FCCB nor any of their respective properties is a party to Seller shall within five (5) Business Days after Seller’s receipt thereof (or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged within two (2) Business Days in the insurance case of deposits (includinga notice that would reasonably result in an obligation of Buyer to report a significant safety issue to the FDA), without limitationinform Buyer of any adverse manufacturing notice to Seller that has a negative impact on the manufacture of the Product, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised byincluding any FDA Form 483 Warning Letter, consent decree, or has other regulatory action that directly impacts the Product (each, an “Adverse Finding”). So long as Seller is taking all reasonable measures to correct and address an Adverse Finding, it shall not be deemed to be in material breach of this Agreement. Buyer shall be responsible for any Knowledge required reporting of facts which could give rise matters regarding the manufacture, integrity, and conformance to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering specifications of Product to the appropriateness of issuing or requesting) any Regulatory OrderFDA in accordance with Applicable Law. (d) Neither CZFS nor FCCB is a party Seller shall be responsible for handling and responding to any agreement with FDA or other governmental agency inspections relating to the Facility and Buyer shall be responsible for handling and responding to any individual FDA or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued other governmental agency inspection with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) Product supplied to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS Buyer pursuant to 12 C.F.R. Part 000this Agreement. Seller shall, Xxxxxxx Xwithin two (2) Business Days, Xxxxxxxx D. Furthermore, the CZFS Board has adopted provide to Buyer any information reasonably requested by Buyer and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective all information requested by any Governmental Authority and that meets governmental agency in connection with any governmental inspection, redacted as needed, related to the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderProduct supplied to Buyer hereunder (subject to any confidentiality or privilege restrictions or obligations to which Seller is subject).

Regulatory Matters. (a) Each of CZFSFrom and after the Closing Date, CZFSAC Buyer, at its cost, shall be solely responsible and FCCB has timely filed liable for (i) taking all reportsactions, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid paying all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any conducting all communication with the appropriate Governmental Authority required by Law in the regular course respect of the business of CZFSRegistrations, CZFSAC and/or FCCBincluding preparing and filing all reports (including adverse drug experience reports, no product deviation reports, annual reports, price reports (including Best Price, Average Manufacturer Price, Average Sales Price, Nonfederal Average Manufacturer Price and Industrial Funding Fee) and marketing disclosure reports) with the appropriate Governmental Authority has initiated (whether any proceedingrelevant Products are sold before or after transfer or reissuance of such Registrations) and shall indemnify and hold harmless Seller against any Damages resulting from preparation, calculation or filing (or failure to file) such reports, (ii) submitting all applications for marketing authorizations of new drugs, where such authorizations have not yet been granted, and variation of existing authorizations, (iii) taking all actions and conducting all communication with third parties with respect to Products sold pursuant to such Registrations (whether sold before or after transfer or reissuance of such Registrations), including responding to all complaints in respect thereof, including complaints related to tampering, contamination, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulationscounterfeiting, and FCCB has a Community Reinvestment Act rating (iv) investigating all complaints and adverse drug experiences with respect to Products sold pursuant to such Registrations (whether sold before or after transfer or reissuance of “satisfactory” or bettersuch Registrations). (b) Other than Seller shall provide Buyer with such data as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed is reasonably necessary to comply with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and Buyer’s reporting obligations under this Section 8.8 for such documents, period as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actis reasonably necessary. (c) Neither CZFSFrom and after the Closing Date, FCCB nor any Seller promptly shall notify Buyer within three (3) Business Days (or such shorter period as is required by Law) if Seller receives a complaint or a report of their respective properties is a party material adverse drug experience with respect to or is subject Products. In addition, Seller shall cooperate with Buyer’s reasonable requests and use commercially reasonable efforts to assist Buyer in connection with the investigation of and response to any Regulatory Order from complaint or adverse drug experience related to Products sold by Seller. Seller will also promptly inform Buyer within three (3) Business Days if: (i) Seller receives any information concerning deviations, changes of process or flaws that may impact the Products, or (ii) Seller receives any announcement or indication of planned or contemplated audits, inspections, or reviews of documents, sites or facilities by any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderAuthority. (d) Neither CZFS nor FCCB is a party From and after the Closing Date, Buyer, at its cost, shall be solely responsible and liable for (i) conducting all voluntary and mandatory recalls of units of Products sold pursuant to any agreement with any individual such Registrations (whether sold before or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing after transfer of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter Xsuch Registrations), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective including recalls required by any Governmental Authority and recalls of units of Products sold by Seller deemed necessary by Seller in its reasonable discretion, (ii) conducting all communications and submitting all required reports to any Governmental Authority concerning the recalls and (iii) notifying customers and consumers about the recalls; provided, however, that meets Seller shall reimburse Buyer for the requirements reasonable expenses and costs of Sections 352 conducting reasonable recalls, withdrawals, field corrections or lookback disposals subject to Section 2.3(d), including the costs of notifying customers and 326 consumers, the costs associated with shipment of such recalled Products, the price paid for such Products, and all other applicable provisions reasonable credits extended to customers in connection with the recall. Seller promptly shall notify Buyer in the event that a recall of Products sold by Seller is necessary. (e) Seller and Buyer each agree to prepare and file whatever filings, requests or applications are required or deemed advisable to be filed with any Governmental Authority in connection with the Transactions and transfer and assumption of the USA PATRIOT Act Registrations by Buyer, including reissuance of the Product BLAs to Buyer, at the Effective Time, including the filings contemplated by Sections 3.2(a)(vi) and 3.2(b)(v), and to cooperate with one another as reasonably necessary to accomplish the regulations thereunderforegoing, including providing written permission to communicate with the FDA with respect to the foregoing. Seller agrees to provide written authorization to the FDA for Buyer to act as a representative agent for each Product BLA from the Effective Time until such time as the Product BLAs are reissued to Buyer.

Regulatory Matters. (a) Each The Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA in other applicable jurisdictions) all required material filings, declarations, listings, registrations, reports or submissions. To the knowledge of CZFSthe Company, CZFSAC all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and FCCB has timely filed all reports, registrations and statements, together with no material deficiencies have been asserted in writing to any amendments required to be made of the Acquired Corporations by any applicable Governmental Body with respect theretoto any such filings, declarations, listings, registrations, reports or submissions, except for those deficiencies that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable have been addressed in connection therewith. Except for normal examinations conducted full by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterCompany. (b) Other than The Acquired Corporations hold all material Regulatory Permits required under applicable Legal Requirements for their business as set forth currently conducted, and, to the knowledge of the Acquired Corporations, each such Regulatory Permit is valid and in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC in full force and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, effect. The Acquired Corporations are in compliance in all material respects with the Securities Act terms and requirements of such Regulatory Permits. No material deficiencies have been asserted in writing to any of the Exchange ActAcquired Corporations by any applicable Governmental Body with respect to any material Regulatory Permits of the Acquired Corporations. (c) Neither CZFSAll preclinical and clinical investigations sponsored by the Acquired Corporations since January 1, FCCB nor 2019 have been and are being conducted in material compliance with all applicable Legal Requirements, including Good Clinical Practices requirements, requirements relating to xxxxxxxxxxxxxx.xxx, and federal and state laws, rules and regulations restricting the use and disclosure of individually identifiable health information, including those similar requirements as applicable in jurisdictions outside the United States. No Acquired Corporation has received any of their respective properties is a party written notice from the FDA or any other Governmental Body in the United States or elsewhere performing functions similar to or is subject those performed by the FDA with respect to any Regulatory Order from any Governmental Authority charged with ongoing clinical or preclinical investigations requiring the supervision termination, suspension or regulation material modification of financial institutions such studies or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordertests. (d) Neither CZFS nor FCCB No Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statement to the FDA or any Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or any Governmental Body, or (iii) to the knowledge of the Company, committed any other act, made any statement or failed to make any statement, that (in any such case) establishes a reasonable basis for the FDA or any Governmental Body to invoke its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or any similar policy administered in any other applicable jurisdiction. No Acquired Corporation is a party the subject of any pending, or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or by any Governmental Body pursuant to any agreement similar Legal Requirement. As of the date of this Agreement, no Acquired Corporation nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators has been suspended, disqualified, debarred or convicted of any crime or, to the knowledge of the Company, engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. § 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement. (e) Each Acquired Corporation and the products manufactured or marketed by or on behalf of such Acquired Corporation have, since January 1, 2019, been in compliance in all material respects with any individual or group regarding CRA matters all Legal Requirements applicable to ophthalmic pharmaceutical companies and neither CZFS nor FCCB has any Knowledge ofto the operation of such Acquired Corporation’s business, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for including the year ended December 31FDCA, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, its foreign equivalents and the regulations promulgated thereunder. No Acquired Corporation or, to the knowledge of the Company, third party that manufactures or commercializes finished product on behalf of the Acquired Corporations (but only in their capacity as such) has been subject to any enforcement, regulatory or administrative proceedings against or affecting such Acquired Corporation or such third party relating to or arising under the FDCA or similar Legal Requirements and no such enforcement, regulatory or administrative proceeding has been threatened in writing. No Acquired Corporation or to the knowledge of the Company third party that manufactures or commercializes finished product on behalf of any Acquired Corporation (but only in their capacity as such) is party to or has any ongoing obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body. (f) Each Acquired Corporation has operated its business in compliance in all material respects with all applicable Legal Requirements, clinical trial protocols, and contractual or other requirements that regulate or limit the maintenance, use, disclosure or transmission of medical records, clinical trial data, patient information or other Personal Information made available to or collected by or on behalf of any of the Acquired Corporations in connection with the operation of the Acquired Corporations’ businesses, including the U.S. Health Insurance Portability and Accountability Act of 1996, as amended by the U.S. Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPAA”), the U.S. Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of the foregoing, as well as applicable similar requirements in any applicable regime (the “Health Care Data Requirements”). In conducting the Acquired Corporations’ businesses, each Acquired Corporation has been in compliance in all material respects with applicable confidentiality, security and other measures required by the Health Care Data Requirements and all applicable privacy and security requirements of HIPAA and HITECH. As of the date of this Agreement, no Acquired Corporation has suffered any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, Personal Information or suffered any security breach in relation to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation any other data which it holds. As of the federal Bank Secrecy Actdate of this Agreement, no breach has occurred with respect to any unsecured Protected Health Information, as that term is defined in 45 C.F.R. §160.103, maintained by or for any Acquired Corporation that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D, and, no information security or privacy breach event has occurred that would require notification under any Health Care Data Requirement. (g) Since January 1, 2019, none of the Acquired Corporations has received any written notice from a Governmental Body alleging or asserting that any of their products are misbranded as defined in 21 U.S.C. § 352 or adulterated as defined in 21 U.S.C. § 351, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 rules and regulations promulgated thereunder, or as well as the provisions defined in comparable Legal Requirements in any jurisdiction. The products manufactured or marketed by or on behalf of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000Acquired Corporations have complied in all material respects with all applicable Legal Requirements, Xxxxxxx Xincluding cGMP, Xxxxxxxx D. Furthermoreand, since January 1, 2019, the CZFS Board promotional materials and claims made by the Acquired Corporations for the products manufactured or marketed by or on behalf of the Acquired Corporations have complied in all material respects with all applicable Legal Requirements. (h) Since January 1, 2019, there have been no product recalls conducted by the Acquired Corporations, no product recalls of product manufactured by or on behalf of the Acquired Corporations, and no written requests from any Governmental Body requiring any Acquired Corporation to cease manufacturing, marketing, distributing or selling any products of the Acquired Corporations. Since January 1, 2019, no Governmental Body (including the FDA or similar entities) has adopted and CZFS initiated an injunction, seizure, or import or export prohibition against any Acquired Corporation, any product manufactured or marketed by or on behalf of any Acquired Corporation, or any third party establishment that manufactures or tests product on behalf of any Acquired Corporation (but only in their capacity as such). Since January 1, 2019, the Acquired Corporations have not received a “warning letter” or “untitled letter” or similar correspondence or written notice from any Governmental Body (including the FDA or similar entities), nor has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not any Acquired Corporation been deemed ineffective asked or directed by any Governmental Authority and that meets Body (including the requirements FDA or similar entities) to make material changes to any of Sections 352 and 326 and all other applicable provisions its products or product candidates. No Acquired Corporation has received an FDA Form 483 or similar list of regulatory observations from any Governmental Body (including the FDA or similar entities), and, to the knowledge of the USA PATRIOT Company, the observations that have been received have been addressed to the satisfaction of the issuing authorities. (i) To the knowledge of the Company, since January 1, 2019, no Person has filed against the Company a Legal Proceeding relating to the False Claims Act and of 1863 (31 U.S.C. § 3729 et seq.) or equivalent state statute, which was disclosed to the regulations thereunderCompany.

Regulatory Matters. (a) Each The business of CZFS, CZFSAC the Borrower and FCCB the Subsidiaries has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authoritybeen, and has paid currently is, being conducted in material compliance with all fees applicable U.S. federal, state, local or foreign laws, Privacy Laws, statutes, ordinances, rules, regulations, guidances, judgments, orders, injunctions, decrees, arbitration awards and assessments due and payable in connection therewith. Except for normal examinations conducted Regulatory Authorizations (including Key Permits) issued by any Governmental Authority in the regular course of the business of CZFS(collectively, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactoryLaws”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V FD&C Act and Public Health Service Act (PHSA). The Products of the Xxxxx-Xxxxx-Xxxxxx Borrower and the Subsidiaries are not, and have not been, “adulterated” or “misbranded” within the meaning of the FD&C Act, nor do any such Products constitute an article prohibited from introduction into interstate commerce under the FD&C Act. (b) The Products have been manufactured, tested, packaged, labeled, distributed, imported, exported, marketed or sold in compliance in all material respects with all applicable requirements under the FD&C Act and the regulations of 1999 the FDA promulgated thereunder and similar Laws in any foreign jurisdiction, including those relating to investigational use, premarket clearance, registration and listing, marketing approval to market a Product, good manufacturing practices, quality systems regulations promulgated thereunderand requirements, ISO requirements, good clinical practices, good laboratory practices, labeling, advertising, record keeping and filing of required reports and security. (c) The Borrower and the Subsidiaries own, free and clear of all Liens, except those permitted pursuant to Section 8.3, all Key Permits, including all authorizations under the FD&C Act and state Laws, necessary for the research and development and commercialization of the Products and to carry on the Borrower’s and Subsidiaries’ businesses, as well applicable. All such Key Permits are valid, and in full force and effect and the Borrower and the Subsidiaries are in compliance in all material respects with all terms and conditions of such Key Permits. Neither Borrower nor any Subsidiary has received any written notice that any Key Permits have been or are being revoked, withdrawn, suspended, limited or challenged. (d) The Borrower has made available to the Administrative Agent and the Lenders copies of all Key Permits and material correspondence submitted to or received from the FDA or other Governmental Authority (including minutes and official contact reports relating to any material communications with any Governmental Authority) in the Borrower’s or any Subsidiary’s possession or control as requested by the Administrative Agent or any Lender. There has been no material untrue statement of fact and no fraudulent statement made by the Borrower, any of the Subsidiaries, or any of their respective agents or representatives to the FDA or any other Governmental Authority, and there has been no failure to disclose any material fact required to be disclosed to the FDA or any other Governmental Authority. All applications, notifications, product reports, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the provisions basis for or submitted in connection with any and all requests for Key Permit from any Governmental Authority, were truthful, complete and accurate in all material respects as of the date of submission and as of the date of the grant of such Key Permit. All necessary or required changes, supplements, amendments, modifications, updates, or corrections to such applications, notifications, submissions, information security program adopted and data have been submitted to the applicable Governmental Authority. (e) Neither the Borrower nor any Subsidiary has had any product or manufacturing site (whether owned by CZFS pursuant the Borrower, a Subsidiary or a contract manufacturer) subject to 12 C.F.R. Part 000a Governmental Authority shutdown or import or export prohibition, Xxxxxxx Xnor received any notice of inspectional observations, Xxxxxxxx D. Furthermore“warning letters,” “untitled letters” or similar correspondence relating to manufacturing processes or procedures and asserting noncompliance with any applicable Law or Permit and, to the CZFS Board has adopted knowledge of the Borrower, no Governmental Authority is considering such action. (f) There are not and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has have not been deemed ineffective any (i) recalls, field notifications, corrections, product replacements, market withdrawals, warnings, inquiries, “dear doctor” letters, investigator notices, safety alerts, reports of accidental radiation occurrences, notifications of defect, or other notices of any action or court order relating to an alleged lack of safety or regulatory compliance of the medical device products issued by the Borrower or any Subsidiary (“Safety Notices”), or (ii) material product complaints with respect to the medical device products. To the knowledge of the Borrower, there are no facts that would be reasonably likely to result in (x) a material Safety Notice with respect to its products, (y) a material change in the labeling of any of its products, or (z) a termination or suspension of developing and testing of any of its products. All adverse events and malfunctions have been reported to applicable Governmental Authorities in accordance with Law. (g) To the Borrower’s knowledge, no investigation by any Governmental Authority with respect to the Borrower or any of the Subsidiaries is pending or threatened. Neither the Borrower nor any Subsidiary has received any written communication from any Person (including any Governmental Authority) of any noncompliance with any Laws or any written communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products, or the practices of the Borrower or any of the Subsidiaries with respect to advertising, promoting, or otherwise commercializing the Products, and to the knowledge of the Borrower, there is no basis for any adverse regulatory action against the Borrower or any of the Subsidiaries. (h) No right of the Borrower or any of the Subsidiaries to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other Third Party, and neither the Borrower nor any of the Subsidiaries has been the subject of any inspection, investigation, or audit, by any Governmental Authority in connection with any alleged improper activity. (i) There is no arrangement relating to the Borrower or the Subsidiaries providing for any rebates, kickbacks or other forms of compensation that meets are unlawful to be paid to any Person in return for the requirements purchase or use of Sections 352 any of the Products or for the referral of business or for the arrangement for recommendation of such referrals. All xxxxxxxx by the Borrower and 326 the Subsidiaries for its services, if any, have been true and correct in all material respects and, to the Borrower’s knowledge, are in compliance with all applicable Laws, including the Federal False Claims Act or any applicable state false claim or fraud Law. (j) None of the Borrower or any of the Subsidiaries nor, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Borrower or any of the Subsidiaries has been convicted of, charged with or, to the Borrower’s knowledge, investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any such program; or, to the Borrower’s knowledge, has been convicted of, charged with or, to the Borrower’s knowledge, investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of the Subsidiaries nor, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Borrower or any of the Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted or would reasonably be expected to result in a debarment or exclusion under (i) 21 U.S.C. Section 335a, (ii) Section 1128 of the Social Security Act or (iii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of the Subsidiaries, are pending or, to the Borrower’s knowledge, threatened against the Borrower, any of the Subsidiaries or any individual who is an officer, director, manager or employee of, or, to the Borrower’s knowledge, an agent or managing agent of, the Borrower or any of the Subsidiaries. (k) The Products were researched, developed, designed and validated in compliance in all material respects with all applicable Laws, including the FD&C Act, Privacy Laws and state laws. All studies, tests and preclinical and clinical trials conducted relating to the Products, by or on behalf of the Borrower and the Subsidiaries and, to the knowledge of the Borrower, their respective licensees, licensors and Third Party services providers and consultants, have been conducted, and are currently being conducted, in compliance in all material respects with all applicable Laws, procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules,regulations and guidance. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Administrative Agent or any Lender as requested by it. To the extent required by applicable provisions Law, the Borrower and the Subsidiaries have obtained all necessary Regulatory Authorizations, including an investigational device exemption (IDE) for the conduct of any clinical investigations conducted by or on behalf of the USA PATRIOT Act Borrower or any of the Subsidiaries. (l) To the Borrower’s knowledge, none of the clinical investigators in any clinical trial conducted by or on behalf of the Borrower or any Subsidiary has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any other Governmental Authority and, to the regulations thereunderBorrower’s knowledge, no such disqualification, or other sanction of any such clinical investigator is pending or threatened in writing or, to the Borrower’s knowledge, otherwise. Neither the Borrower nor any of the Subsidiaries has received from the FDA or other applicable Governmental Authority any written or, to its knowledge, other notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any clinical trials conducted by, or on behalf of, the Borrower or any of the Subsidiaries.

Regulatory Matters. (a) Each Seller possesses, or has a right of CZFSreference to, CZFSAC all material Regulatory Approvals necessary to conduct the Product Business as currently conducted in the Buyer Territory. The U.S. Regulatory Approval is in full force and FCCB effect. During the [REDACTED] Seller has timely filed all reports, registrations and statements, together with not received any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by written communication from any Governmental Authority in the regular course Buyer Territory threatening to revoke, withdraw, modify, suspend, cancel or terminate the U.S. Regulatory Approval. No proceeding is pending or, to Seller’s Knowledge, threatened regarding the suspension or revocation of the business U.S. Regulatory Approval. Seller is not, and during the [REDACTED] has not been, in violation of CZFSthe terms of the U.S. Regulatory Approval. Seller has not previously sold, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceedinglicensed, or to transferred in any manner, in whole or in part, the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterU.S. Regulatory Approval. (b) Other than as set forth During the [REDACTED], with respect to the Product in CZFS Disclosure Schedule 4.11the Buyer Territory, since January 1Seller has not and, 2020to Seller’s Knowledge, CZFS has timely filed no Third Party contract manufacturer, packager, labeler, or other vendor that must list the Product with the SEC and NASDAQ all documents required by FDA has, received or been subject to: (i) any Form 483s, warning letters or other written correspondence from the Securities Act and FDA with respect to the Exchange Act and Product in which the FDA asserted that the operations of Seller or any such documents, as Third Party relating to the same may have been amended, complied, at Product were not in compliance with applicable Law; or (ii) any warning letters or other written communication from any other Governmental Authority with respect to the time filed Product in the Buyer Territory in which such other Governmental Authority asserted that the Product Business or operations of Seller or any such Third Party relating to the Product were not in compliance with the SEC, in all material respects with the Securities Act and the Exchange Actapplicable Law. (c) Neither CZFSDuring the [REDACTED] there has not been any product recall, FCCB nor dear doctor letter or market withdrawal or replacement conducted by or on behalf of Seller concerning the Product in the Buyer Territory or any product recall, dear doctor letter, market withdrawal or replacement conducted by or on behalf of their respective properties is any Third Party as a party to or is subject to result of any Regulatory Order from alleged defect in the Product in the Buyer Territory. During the [REDACTED] Seller has not received any written notice that any Governmental Authority charged with has commenced, or threatened to initiate, any action to request a recall of the supervision or regulation of financial institutions or issuers of securities or engaged Product in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised byBuyer Territory, or has any Knowledge of facts which could give rise commenced, or threatened to an advisory notice byinitiate, any action to enjoin production at any facility at which the Product is Manufactured for distribution in the Buyer Territory. Seller has made available to Buyer true and correct summary reports regarding material complaints and notices of alleged defect or adverse reaction with respect to a Product in the Buyer Territory that have been received in writing by Seller during the [REDACTED] During the [REDACTED] Seller has not received any written notice that the FDA or any other Governmental Authority that such Governmental Authority is contemplating issuing has (i) commenced, or requesting threatened to initiate, any action to enjoin the Manufacture or Exploitation of the Product in the Buyer Territory or (ii) commenced, or is considering threatened to initiate, any action to enjoin the appropriateness Manufacture or Exploitation of issuing or requesting) any Regulatory Orderthe Product in the Buyer Territory. (d) Neither CZFS nor FCCB is To the Knowledge of Seller, there are no existing circumstances which would reasonably be expected to furnish a party basis for an action by FDA or any other Governmental Authority to revoke, suspend, cancel, modify or withdraw the U.S. Regulatory Approval. (e) During the [REDACTED] the Product in the Buyer Territory has been Manufactured in compliance with applicable Law, including the Act and cGMP, and the U.S. Regulatory Approval. During the [REDACTED] neither Seller, nor, to Seller’s Knowledge, any employee or agent of Seller, has made on behalf of Seller any material false statements or material omissions in any application or other submission to the FDA or other Governmental Authority in the Buyer Territory relating to the Product, the Product Business or the Purchased Assets. (f) None of Seller or any employee or, to Seller’s Knowledge, any consultant of Seller who has undertaken activities in connection with the Product Business in the [REDACTED], has been debarred, restricted, suspended or deemed subject to debarment by the FDA, nor, to Seller’s Knowledge, are any such Persons the subject of a conviction described in, (i) Section 306 of the Act or (ii) 42 U.S.C. §1320a-7 or any similar debarment or ineligibility provisions applicable to any health care program of a Governmental Authority. (g) Seller has not entered into any settlement agreement, corporate integrity agreement, or similar agreement with any individual Governmental Authority relating to the Product, the Purchased Assets or group regarding CRA matters and neither CZFS nor FCCB the Product Business that would be binding on the Buyer or under which the Buyer would have any payment, reporting, or other obligations to any Governmental Authority. (h) Seller has not notified, either voluntarily or as required by applicable Law, any Knowledge ofaffected individual, nor any Governmental Authority, or the media of any breach of Personal Information. Seller has CZFS not suffered any unauthorized acquisition, access, use or FCCB been advised disclosure of any Personal Information relating to the Product, the Product Business or the Purchased Assets that, individually or in writing the aggregate, materially compromises the security or privacy of such Personal Information. (i) (i) There are no pending preclinical tests or has clinical trials by or on behalf of Seller or any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed of its Affiliates associated with the FDIC, or otherwiseProduct and (ii) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that Seller has not been deemed ineffective by received written notice of and, to Seller’s Knowledge, there are no currently outstanding or unanswered questions from FDA regarding any Governmental Authority and that meets pending clinical studies involving the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderProduct.

Regulatory Matters. (a) Each of CZFSAt all times after the Effective Date, CZFSAC Metabolex shall own and FCCB has timely filed maintain, at its own cost, all reportsregulatory filings and Regulatory Approvals for PPAR-d Products that Metabolex is developing or commercializing pursuant to this Agreement, registrations and statementsincluding all INDs, together with any amendments required to be made with respect theretoCTAs, that it was required to file since January 1, 2020 with any Governmental AuthorityNDAs, and has paid statistical analyses. As such, Metabolex shall be responsible for reporting all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority adverse drug reactions related to PPAR-d Products to the appropriate regulatory authorities in the regular course of relevant countries, in accordance with the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulationsregulations of such countries. As soon as practicable, but not more than thirty (30) days after the Effective Date, Xxxxxxx shall transfer ownership of, and FCCB all files relating to, its regulatory filings and associated with PPAR-d Products to Metabolex (including, but not limited to, any INDs Controlled by Xxxxxxx or its Affiliates). Metabolex shall provide Xxxxxxx with copies of the draft [*] = Certain confidential information contained in this document, marked by brackets, has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely been omitted and filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects separately with the Securities Act and the Exchange Act. (c) Neither CZFS, FCCB nor any of their respective properties is a party Commission pursuant to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation Rule 24b-2 of the federal Bank Secrecy ActSecurities Exchange Act of 1934, as amended. registration submissions in connection with obtaining Regulatory Approval for a PPAR-d Product in the Major Markets, prior to their submission, and Xxxxxxx shall have the right to review such draft submission and provide comments thereon to Metabolex, which Metabolex agrees to reasonably consider. Xxxxxxx also agrees to discuss and answer any questions relating to PPAR-d Know-How that Metabolex may have regarding regulatory matters for PPAR-d Products. Metabolex shall also be responsible for all meetings with regulatory authorities and all post-approval commitments. Notwithstanding the above, Xxxxxxx shall prepare and file a FDA regulatory submission covering the [*]. Xxxxxxx shall provide Metabolex with a copy of the draft submission prior to its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Actsubmission, and Metabolex shall review such draft submission and provide comments thereon to Xxxxxxx, which Xxxxxxx agrees to consider and incorporate into the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be submission if in material compliance with the applicable requirements contained in any federal Xxxxxxx’x reasonable judgment such suggestions are justified and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderproper.

Regulatory Matters. (a) Each The Company shall, to the extent permitted by applicable Law, promptly provide Parent with a copy of CZFSall written or oral correspondence received after the date hereof from the FDA or any other Regulatory Authority performing functions similar to those performed by the FDA concerning any Product and Governmental Authorization (or applications therefor) regarding any (i) approval, CZFSAC and FCCB has timely filed all reportswithdrawal, registrations and statementsdelay, together with suspension, termination, placement on inactive status (including any amendments required to be made clinical hold) or revocation of any approval for such Product, (ii) prohibition, suspension or material delay of the supply of such Product, (iii) new or expanded investigation, review or inquiry concerning the safety of such Product, or (iv) requests for information or meetings with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersuch Product. (b) Other than as set forth Prior to the Closing Date, the Company shall, to the extent permissible under applicable Law, inform Parent of, and provide Parent with a reasonable advance opportunity to review and comment on any material filing proposed to be made by or on behalf of the Company or any of its Subsidiaries with respect to any Product, and any material correspondence or other material communication proposed to be submitted or otherwise transmitted to the FDA or any other Regulatory Authority performing functions similar to those performed by the FDA by or on behalf of the Company or any of its Subsidiaries. The Company and the Company Subsidiaries shall consult with, and consider any comment from, Parent in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed good faith prior to making any material submissions to or having material discussions with the SEC and NASDAQ all documents required FDA or any other Governmental Body or Regulatory Authority performing functions similar to those performed by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActFDA. (c) Neither CZFSPrior to the Closing Date, FCCB nor the Company shall, to the extent permissible under applicable Law, reasonably promptly (and in any event within three (3) business days upon discovery by the Company) notify Parent in writing of (i) any material FDA Form 483, warning letter, untitled letter, or other similar material correspondence or notice from the FDA or any other applicable Regulatory Authority alleging or asserting material noncompliance with any applicable Laws or Regulatory Authorizations received by the Company, its Subsidiaries, or to the knowledge of the Company, any of their respective properties is a party contract manufacturers with respect to the Products (ii) any written notices, correspondence, or is subject to any Regulatory Order other communication from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitationinstitutional review board, the PADOBS and FDA or any applicable Regulatory Authority, recommending or requiring the FRB) termination, suspension, or the supervision material modification of any ongoing or regulation of it. Neither CZFS nor FCCB has been advised planned clinical trials conducted by, or has on behalf of, the Company or any Knowledge of facts which could give rise to an advisory notice byits Subsidiaries, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requestingiii) any Legal Proceedings (whether complete or pending) or request from a Regulatory Order. Authority seeking the recall, withdrawal, suspension or seizure of any Product or (div) Neither CZFS nor FCCB is a party to any agreement with written notice or other communication from any individual applicable Regulatory Authority (A) withdrawing or group regarding CRA matters and neither CZFS nor FCCB has placing any Knowledge of, nor has CZFS of the Products on “clinical hold” or FCCB been advised in writing requiring the termination or suspension of any pre-clinical studies or has clinical trials of the Products or (B) alleging any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderLaw.

Regulatory Matters. (a) Schedule 3.10(a)(i) sets forth a true and complete list of (i) all Regulatory Authorizations held by Seller or under which Seller conducts business, or that have been submitted by or on behalf of Seller, in each case, relating to the Business or a Product, and (ii) all applications or notifications or submissions for Regulatory Authorizations pending in relation thereto. Seller owns or has sufficient rights under all material Regulatory Authorizations that are required for or relate to the Business. Each such Regulatory Authorization (A) has been validly issued or acknowledged by the appropriate Regulatory Authority and is in full force and effect and (B) to the extent constituting a Purchased Asset, such Regulatory Authorizations or Seller’s and its Subsidiaries’ rights therein are transferable to Buyer. To Seller’s Knowledge, there are no facts, circumstances or conditions that would prevent the transfer of CZFSany Regulatory Authorization held by Seller or any of its Subsidiaries to Buyer on or after the Closing Date. Seller and its Subsidiaries have received no notice of any action pending or recommended by any Regulatory Authority to revoke, CZFSAC withdraw, suspend or materially limit any Regulatory Authorization. With respect to each Product, Seller has made available to Buyer complete and FCCB has timely filed accurate copies of all reportsmaterial applications, registrations registrations, licenses, waivers, accreditations, authorizations, approvals, and statements, together clinical and preclinical data in the possession or control of Seller and its Subsidiaries and all material written correspondence between Seller and its Subsidiaries and the applicable Regulatory Agency (including minutes and official contact reports of communications with any amendments required to be made with respect theretoapplicable Regulatory Authority) and all material supporting documents, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted each case as requested by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterBuyer. (b) Other than The Seller and its Subsidiaries have not failed to file with any applicable Regulatory Authorities any required filing, declaration, listing, registration, report or submission (including, without limitation); (ii) all such filings, declarations, listings, registrations, reports or submissions were in material compliance with Law when filed; and (iii) to Seller’s Knowledge, no deficiencies have been asserted by any applicable Regulatory Authority with respect to any such filings, declarations, listings, registrations, reports or submissions that remain unresolved. (c) Except as set forth on Schedule 3.10(c), all pre-clinical and clinical studies, trials and investigations conducted or sponsored in CZFS Disclosure Schedule 4.11relation to the Business are being, since January 1and at all times have been, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, conducted in compliance in all material respects with all applicable clinical protocols, informed consents and applicable Laws administered or issued by applicable Regulatory Authorities, including (to the Securities Act extent applicable) (i) the U.S. Food and Drug Administration (“FDA”) or other health authority standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Exchange Act. Code of Federal Regulations and associated regulatory guidance, (cii) Neither CZFSinvestigational new drug requirements and associated regulatory guidance, FCCB nor (iii) FDA or other Regulatory Authority or other Governmental Authority standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials, including Title 21 parts 50, 54, 56, 312, 314, and 320 of the Code of Federal Regulations and associated regulatory guidance, (iv) Laws or other Regulatory Authority standards for restricting the use and disclosure of individually identifiable health information, (v) the International Council for Harmonisation Guideline on Good Clinical Practice (ICH Topic E6) and associated regulatory guidance and (vi) communications or notices from Regulatory Authorities regarding the conduct of such studies, trials and investigations. All clinical trial adverse events in patients in a clinical trial conducted or sponsored in relation to the Business within the knowledge of Seller have been disclosed to Buyer and all associated correspondence to or from Seller or any of their respective properties is a party its Subsidiaries, including actual or potential claims for recompense, have been made available to Buyer. The Seller and its Subsidiaries have received no notices or is subject to other correspondence from the FDA or any Regulatory Order committee thereof or from any Governmental other Regulatory Authority charged with or other Government Authority requiring or recommending the supervision termination or regulation suspension of financial institutions any clinical trials related to the Products. The Seller and its Subsidiaries have not been informed by the FDA that the FDA will prohibit the marketing, sale, license or issuers of securities or engaged use in the insurance United States of deposits (includingany Future Product proposed to be developed, without limitationproduced or marketed by Seller or its Subsidiaries nor has the FDA provided written notice or, the PADOBS and the FRB) to Seller’s Knowledge, otherwise expressed or the supervision conveyed any concern as to approving or regulation clearing for marketing any Future Product being developed or proposed to be developed by Seller or any of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderits Subsidiaries. (d) Neither CZFS nor FCCB No Product manufactured or distributed by Seller or any of its Subsidiaries is or has been (i) adulterated within the meaning of 21 U.S.C. § 351 (or similar Laws), including, but not limited to, applicable requirements of 21 C.F.R. Parts 600, or 1271, (ii) misbranded within the meaning of 21 U.S.C. § 352 (or similar Laws) or (iii) a party product that is in violation of 21 U.S.C. § 355, § 360, § 360e (or similar Laws). (e) To Seller’s Knowledge, no Regulatory Authority has commenced or threatened to initiate any Action to place a clinical hold order on, or otherwise terminate, delay or suspend any proposed or ongoing pre-clinical or clinical studies, trials, IND application or investigations conducted or proposed to be conducted in connection with the Business. (f) Seller and its Subsidiaries have not directly or indirectly received any written communication (including any warning letter, untitled letter, Form 483 or similar notice) from any Regulatory Authority except as disclosed in Schedule 3.10(f), and, to Seller’s Knowledge, there are no material Actions related to the Business pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), in each case (i) relating to, arising under or alleging that Seller or any of its Subsidiaries, officers, employees or agents is not currently in compliance with, any Law administered or issued by any Regulatory Authority or (ii) regarding any debarment action or investigation in respect of Seller or any of its officers, employees or agents undertaken pursuant to 21 U.S.C. Sections 335(a), (b) and (c), or any similar regulation of a Regulatory Authority. To Seller’s Knowledge, there are no pending voluntary or involuntary destruction orders, seizures or other regulatory enforcement actions related to the Business and no Data relating to any agreement Product that has been made public is the subject of any regulatory or other Action, either pending or threatened, by any Regulatory Authority questioning the truthfulness or scientific adequacy of such Data. (g) All of the manufacturing facilities and operations of the Seller and its Subsidiaries and, to Seller’s Knowledge, its and their suppliers or contract manufacturers are in compliance in all material respects with any individual applicable Law addressing current good manufacturing practices and laws and standards related to marketing, promotion, imports and exports, and off- label uses. No Product is under consideration by senior management of Seller for recall, withdrawal, removal, suspension, seizure or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge ofdiscontinuation, nor has CZFS or FCCB been advised in writing of or has been recalled, withdrawn, removed, suspended, seized or discontinued (other than for commercial or other business reasons) by Seller or any reason to believe of its Subsidiaries, in the United States or outside the United States (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, whether voluntarily or otherwise) that and, to Seller’s Knowledge, no legal proceedings in the United States or outside of the United States (whether completed or pending) seeking the recall, withdrawal, suspension, seizure or discontinuation of any facts Product are pending against Seller or circumstances existits Subsidiaries, which would cause CZFS or FCCB: its or their agents or any licensee of any Product. (ah) Neither Seller nor its Subsidiaries nor, to Seller’s Knowledge, any officer, employee, agent or distributor of Seller or its Subsidiaries, has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Governmental Authority, failed to disclose a material fact required to be deemed not disclosed to the FDA or any other Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made, would reasonably be in satisfactory compliance with expected to provide a basis for the CRAFDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and the regulations promulgated thereunderIllegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to be assigned a rating invoke any similar policy. Neither Seller, its Subsidiaries nor, to Seller’s Knowledge, any officer, employee or agent of Seller or its Subsidiaries has been convicted of any crime or engaged in any conduct for CRA purposes which debarment is mandated by Bank Regulators of lower than “satisfactory”; or authorized by 21 U.S.C. Sections 335(a), (b) and (c) or any similar Laws. Neither Seller nor, to Seller’s Knowledge, any officer, employee or agent of Seller has been convicted of any crime or engaged in any conduct for which such Person would be deemed to be operating excluded from participating in material violation the Federal health care programs under Section 1128 of the federal Bank Secrecy ActSocial Security Act of 1935, as amendedamended (the “Social Security Act”), or any similar Laws. (i) Seller and its Subsidiaries are, and, since the Measurement Date, have been, in compliance with: (i) Laws and guidance pertaining to state and federal Anti-Kickback Statutes (42 U.S.C. §§ 1320a-7b(b), et seq. and their implementing regulations) and the related Safe Harbor Statutes; (ii) Laws and guidance pertaining to submission of false claims to governmental or private health care payors (31 U.S.C. §§ 3729, et seq. and its implementing regulations regulations); and (31 C.F.R. Chapter X)iii) Laws relating to providing and reporting of payments to health care professionals or health care entities. With respect to interactions with healthcare professionals, Seller and its Subsidiaries follow their corporate compliance program, both in the USA PATRIOT ActUnited States and in foreign countries, which complies with Law and Seller believes is the substantial equivalent of the PhRMA Code on Interactions with Healthcare Professionals and/or the International Federation of Pharmaceutical Manufacturers Associations’ Code of Pharmaceutical Marketing Practices and the European Federation of Pharmaceutical Industries’ Associations’ European Code of Practice for the Promotion of Prescription-only Medicines, and Interactions with, Healthcare Professionals in the regulations promulgated thereunder, respective countries and states and related jurisdictions to which those or similar codes and standards apply. (j) Seller has not presented or caused to be presented to any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, Governmental Authority or any other applicable antiPerson any claim for payment for an item or service in violation of, or that would be the basis for liability under, the False Claims Act, 31 U.S.C. § 3729 – 3733, any similar state false claims act, the Civil Monetary Penalties Law, 42 U.S.C. §§ 1320a-7a and 1320a-7b, the Program Fraud Civil Remedies Act, 31 U.S.C. §§ 3801-money laundering statute3812, rule or regulation; the common law or administrative theories of recoupment, payment by mistake, unjust enrichment, disgorgement, conversion, breach of contract, or fraud. (ck) Seller is a “covered entity” or a “business associate” pursuant to be deemed not to be in material compliance with the applicable requirements contained in any federal Health Insurance Portability and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Accountability Act of 1999 1996 (as those terms are defined in 45 §160.103), and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS Seller has implemented an anti-money laundering program that contains adequate in all material respects any confidentiality, security and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority other measures and that meets the requirements of Sections 352 and 326 and complied in all material respects with all other applicable provisions Laws relating to the privacy, breach notification, or security of individually identifiable information, including the Federal Trade Commission Act, the Children’s Online Privacy Protection Act (COPPA), and similar applicable Laws in any foreign jurisdiction in which Seller does business. Seller has not notified, either voluntarily or as required by Applicable Law, any affected individual, any Governmental Authority, or the media of any breach of personal identifiable information. Seller has not suffered any unauthorized acquisition, access, use or disclosure of any personal information that, individually or in the aggregate, materially compromises the security or privacy of such personal information. (l) Neither Seller nor, to Seller’s Knowledge, any of its officers, employees or agents has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the USA PATRIOT Act and the regulations thereunderSocial Security Act.

Regulatory Matters. (a) Each Sellers have all material Permits required by the FDA and any other Governmental Authority that regulates the manufacture, sale or distribution of CZFSthe Products to conduct the Business (the “FDA Permits”). All of the FDA Permits are in full force and effect, CZFSAC the holder of such permit is in compliance in all material respects with, and FCCB is not in material default under (and to the Knowledge of Sellers, no event which with the giving of notice or lapse of time, or both, would become a material default under), each such FDA Permit, and to the Knowledge of Sellers none of such Permits shall be terminated or impaired or become terminable, in whole or in part, as a result of the transactions contemplated by this Agreement and the other Transaction Documents. To the Knowledge of Sellers, no written notice of cancellation, default or any dispute concerning any FDA Permit has timely filed been received by the Seller or any of its Affiliates. Sellers are the sole and exclusive owners of the FDA Permits and the associated filings and applications with the FDA or any other Governmental Authority, including any BLA, NDA, 510(k) submission, premarket approval, IND or investigational device exemption application, comparable regulatory application or filing made or held by or issued to a Seller or any of its Affiliates (collectively, the “Seller Regulatory Filings”) and hold all reportsright, registrations title and statementsinterest in and to all Seller Regulatory Filings free and clear of any Lien (other than Permitted Liens). No Seller or any of its Affiliates has granted any third party any right or license to use, together access or reference any of the Seller Regulatory Filings, including any of the Know-How contained in any of the Seller Regulatory Filings or rights (including any regulatory exclusivities) associated with any amendments required to be made with respect thereto, that it was required to file since each such Seller Regulatory Filing. (b) Since January 1, 2020 20***, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, market withdrawal, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any Product. (c) With respect to the Products, each Seller and each of its Affiliates is in compliance in all material respects with all Applicable Laws and any other letters, notices or *** Material has been omitted pursuant to a request for confidential treatment and has been filed separately. Table of Contents guidances issued by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biological, device or regenerative medicine products in any jurisdiction. There are no regulatory Actions pending (to the Knowledge of Sellers with respect to audits and investigations) and, to the Knowledge of Sellers, there are no regulatory Actions threatened (in each case, other than non-material routine or periodic inspections) pertaining to any Product against any Person (each, a “Collaborative Partner”) that manufactures any component, ingredient, or material used in manufacturing the Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with a Seller or any of its Affiliates by the FDA or any Governmental Authority which regulates the sale of pharmaceutical products or biologic, device or regenerative medicine products in any jurisdiction. Since January 1, 20*** there have been no written notices, reports, warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted Applicable Law with respect to the Products or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Governmental Authority in the regular course with regard to any Product. (d) The manufacture of the business of CZFSProducts by the Sellers or their Affiliates and, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFSthe Sellers, investigation into the business or operations of CZFS, CZFSAC and/or FCCBby third parties has, since January 1, 2020. FCCB 20***, been and is being conducted in compliance in all material respects with current “well-capitalizedgood manufacturing practices,” as defined in applicable laws and regulationsby the FDA, and FCCB has a Community Reinvestment Act rating of including, as applicable, the FDA’s “satisfactoryQuality System Regulation” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.1121 C.F.R. Part 820 and 21 C.F.R. Parts 211, 600 & 820. The sale of Products with Regulatory Approvals by Healthpoint or any of its Affiliates has, since January 1, 202020***, CZFS been and is being conducted in all material respects in accordance with those Regulatory Approvals and without unlawful promotion of “off-label” or other prohibited uses. (e) Each Seller and its Affiliates are and since January 1, 20*** have been with respect to the Business in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Governmental Authority, including, for avoidance of doubt, records and reports relating to product corrections and removals (including FDA requirements set forth in 21 C.F.R. Part 806), MDR Reportable Events (including FDA requirements set forth in 21 C.F.R. Part 803), Adverse Experiences, Serious Adverse Events, Serious Injuries, incidents or near-incidents and product malfunctions. (f) No Seller, any of its Affiliates or, to the Knowledge of Sellers, any of their respective Collaborative Partners, agents or subcontractors with respect to the Business (i) has timely been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Governmental Authority or (ii) has failed to disclose a material fact required to be disclosed to any Governmental Authority with respect to the Purchased Assets, and there are no proceedings pending or, to the Knowledge of Sellers, threatened that would reasonably be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Governmental Authority. No Seller, its Affiliates or, to the Knowledge of Sellers, any of their respective Collaborative Partners has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” or for any other Governmental Authority to invoke any similar policy. *** Material has been omitted pursuant to a request for confidential treatment and has been filed separately. Table of Contents (g) There have been no Serious Adverse Events, Serious Injuries or MDR Reportable Events associated with the SEC use (including in clinical trials) of any Product that have not been reported to the FDA or any other Governmental Authority in accordance with Applicable Law. Prior to the date hereof, Seller Parent has made available to Buyer Domestic (i) a schedule of all payouts made by a Seller or any of its Affiliates to end-users since January 1, 20*** in respect of claims relating to any Product and NASDAQ (ii) a schedule of all documents required actual or threatened (in writing) claims made by end-users against a Seller or any of its Affiliates relating to a Product since January 1, 20***. (h) All studies, tests, and preclinical and clinical research being conducted by a Seller, any of its Affiliates, and to the Knowledge of Sellers, on behalf of a Seller or any of its Affiliates by any of their respective Collaborative Partners, with respect to any Product, are being, and at all times have been, conducted in compliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the Securities FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the Federal Food, Drug and Cosmetic Act and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable Applicable Laws of any other Governmental Authority. No clinical trial conducted by a Seller or any of its Affiliates or, to the Exchange Knowledge of Sellers, on behalf of a Seller or any of its Affiliates, with respect to any Product has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Governmental Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated or, to the Knowledge of Sellers, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other person or Person involved in any such clinical trial. (i) No Seller, any of its Affiliates or any of their respective officers, directors, managing employees (as those terms are defined in 42 C.F.R. § 1001.1001), nor, to the Knowledge of Sellers, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of a Seller or any of its Affiliates is a party to or bound by, any order, individual integrity agreement, corporate integrity agreement or other formal or informal agreement with any Governmental Authority concerning compliance with Applicable Laws governing any Federal Healthcare Program with respect to any Product, and, to the Knowledge of Sellers, no such agreement is threatened in writing. (j) No Seller, any of its Affiliates, nor any of their respective officers, directors, managing employees (as those terms are defined in 42 C.F.R. § 1001.1001), nor, to the Knowledge of Sellers, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of a Seller or any of its Affiliates: (i) has been debarred, excluded or suspended from participation in any Federal Healthcare Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act of 1935, codified at Title 00, Xxxxxxx 0, xx xxx Xxxxxx Xxxxxx Code (the “Social Security Act”); (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and such documentsnon-procurement programs; (iv) to the Knowledge of Sellers, is the target or subject of any current investigation by a Governmental Authority relating to any Federal Healthcare Program-related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Healthcare Program. *** Material has been omitted pursuant to a request for confidential treatment and has been filed separately. Table of Contents (k) There are no filings of an Action pending and, to the Knowledge of Sellers, there are no filings of an Action threatened against a Seller or any of its Affiliates relating to the Business or any Product under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.). (l) To the Knowledge of Sellers, no Seller or any of its Affiliates is under investigation by any Governmental Authority for a violation of the Health Insurance Portability and Accountability Act of 1995, as amended by the same may Health Information Technology for Economic and Clinical Health Act (“HIPAA”), or the regulations contained in 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of Health and Human Services Office of Civil Rights relating to any such violations, or any comparable state or local Applicable Laws. No Seller or any of its Affiliates is a “covered entity” as that term is defined in HIPAA. Each Seller and its Affiliates have been amendedin compliance in all material respects with federal and state data breach Applicable Laws. (m) To the extent a Seller provides reimbursement coding or billing advice regarding any Product or procedures related thereto, complied, at the time filed with the SEC, such advice is and has been true and complete in all material respects and in compliance in all material respects with the Securities Act payment requirements of Medicare and the Exchange Actother Applicable Laws governing a Federal Healthcare Program. (cn) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, Each Seller and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued Affiliates have at all times complied in all material respect with Applicable Laws with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) Business relating to be deemed not to be in material compliance with the applicable requirements contained in any federal security and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderstandards regarding protected health information.

Regulatory Matters. (a) Each of CZFSThe Company is legally, CZFSAC financially and FCCB has timely filed all reportsotherwise qualified under the Communications Act to perform its obligations hereunder, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authoritythe licensee of, and has paid all fees to own and assessments due and payable in connection therewithoperate the Station. Except for normal examinations conducted by any Governmental Authority in To Seller’s Knowledge, no fact or circumstance exists relating to the regular course FCC qualifications of the business Company that (i) could reasonably be expected to prevent or delay the FCC from granting the Assignment Application or (ii) would otherwise disqualify the Company as the licensee, owner, operator or transferee of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterStation. (b) Other than as set forth in CZFS The Disclosure Schedule 4.11sets forth a true and complete list of all FCC Licenses, since January 1, 2020, CZFS has timely all pending applications filed with the SEC and NASDAQ all documents required FCC by the Securities Act Company and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed all Permits held by Company in connection with the SECconduct of the Station Business as conducted immediately prior to the Closing, in all material respects with the Securities Act and the Exchange Actincluding any registrations of Transmission Structures (copies of which are attached thereto). (c) Neither CZFSNo application, FCCB nor action or proceeding is pending for the renewal of any FCC License as to which any petition to deny or objection has been filed and, to Seller’s Knowledge, there is not before the FCC any investigation, proceeding, notice of violation, or order of forfeiture relating to the Company. There is not now pending and, to Seller’s Knowledge, there is not threatened, any action by or before the FCC to revoke, suspend, cancel, rescind or modify any of their respective properties is a party the FCC Licenses (other than proceedings to amend the Communications Act or is subject proceedings of general applicability to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderbroadcast radio industry). (d) Neither CZFS nor FCCB The Station is a party owned and operated by the Company in compliance with (i) the terms of the FCC Licenses and (ii) the Communications Act. The Company has filed or made all applications, reports, and other disclosures required by the FCC to be made in respect of the Station and have or will have timely paid all FCC regulatory fees in respect thereof. No licenses, authorizations, permits or other rights other than the Permits and the FCC Licenses are required to own and operate the Station in substantially the same manner as it is being operated as of the date hereof and as of the Closing Date. The FCC Licenses are in full force and effect; and are not subject to any agreement with any individual condition except conditions applicable to broadcast radio licenses generally, or group regarding CRA matters and neither CZFS nor FCCB as otherwise disclosed on the face of the FCC Licenses. Seller has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any no reason to believe that the FCC will not renew any FCC Licenses in the ordinary course. (based on CZFS’s Home Mortgage Disclosure Act data for e) The Transmission Structures are registered to the year ended December 31extent required by Law and all such Transmission Structures have been constructed, 2021and are operated and maintained, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRAFCC Licenses and all applicable Laws, including the Communications Act and those promulgated by the FAA (and including, to the extent applicable, all such Laws concerning the marking, painting, lighting, height and registration of the Transmission Structures). (f) All transmission and related equipment will be, (i) in good operating condition and adequate repair (ordinary wear and tear excepted) and (ii) operated and maintained in accordance with good engineering practices and in full compliance with all applicable Laws, including the Communications Act and the regulations promulgated thereunderFCC Licenses. The Company has conducted or obtained engineering studies (including studies in respect of wind load) that demonstrate, using good engineering practices, that the Tower has been constructed in a manner sufficient to hold and support the structures currently mounted, or contemplated to be assigned a rating for CRA purposes mounted, thereon (including the Station’s antennae) by Bank Regulators of lower than “satisfactory”; the Station pursuant to the FCC Licenses, any Contract (bincluding this Agreement) to be deemed to be or otherwise. (g) The Station is operating at the effective radiated power authorized under the FCC Licenses. (h) To Seller’s Knowledge, the Station does not cause or receive any interference that is in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, Communications Act or any other applicable anti-money laundering statuteLaws. (i) All returns, rule or regulation; or (c) reports and statements that the Company is currently required to be deemed not to be in material compliance file with the applicable requirements contained in any federal and state privacy FCC or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not FAA have been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderfiled.

Regulatory Matters. (a) Each Upon the execution and delivery of CZFSthis Agreement, CZFSAC St. Paul and FCCB has timely Beverly Corp. (as to information to be included therein pertaining to Beverly Corp.) shall promptly cause to be prepared and filed with the SEC a registration statement of St. Paul on Form S-4, including the Proxy Statement/Prospectus (the "Registration Statement") for the purpose of registering the St. Paul Common Stock to be issued in the Merger, and for soliciting the approval of this Agreement and the Merger by the shareholders of Beverly Corp., and the St. Paul Issuance and St. Paul Amendment by the shareholders of St. Paul. St. Paul and Beverly Corp. shall use their reasonable best efforts to have the Registration Statement declared effective by the SEC as soon as possible after the filing. The parties shall cooperate in responding to and considering any questions or comments from the SEC staff regarding the information contained in the Registration Statement. If at any time after the Registration Statement is filed with the SEC, and prior to the Closing Date, any event relating to Beverly Corp. is discovered by Beverly Corp. which should be set forth in an amendment of, or a supplement to, the Registration Statement, including the Prospectus/Proxy Statement, Beverly Corp. shall promptly inform St. Paul, and shall furnish St. Paul with all reportsnecessary information relating to such event whereupon St. Paul shall promptly cause an appropriate amendment to the Registration Statement to be filed with the SEC. Upon the effectiveness of such amendment, registrations each of St. Paul and statementsBeverly Corp. (if prior to the meeting of shareholders pursuant to Section 6.3 hereof) will take all necessary action as promptly as practicable to permit an appropriate amendment or supplement to be transmitted to its shareholders entitled to vote at such meeting. If at any time after the Registration Statement is filed with the SEC, together and prior to the Closing Date, any event relating to St. Paul is discovered by St. Paul which should be set forth in an amendment of, or a supplement to, the Registration Statement, including the Prospectus/Proxy Statement, St. Paul shall promptly inform Beverly Corp., and St. Paul shall promptly cause an appropriate amendment to the Registration Statement to be filed with the SEC. Upon the effectiveness of such amendment, each of St. Paul and Beverly Corp. (if prior to the meeting of shareholders pursuant to Section 6.3 hereof) will take all necessary action as promptly as practicable to permit an appropriate amendment or supplement to be transmitted to its shareholders entitled to vote at such meeting. St. Paul shall also use reasonable efforts to obtain all necessary state securities law or "Blue Sky" permits and approvals required to carry out the transactions contemplated by this Agreement and the Bank Merger Agreement and Beverly Corp. shall furnish all information concerning Beverly Corp. and the holders of Beverly Common Stock as may be reasonably requested in connection with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersuch action. (b) Other than The parties hereto shall cooperate with each other and use their best efforts to promptly prepare and file all necessary documentation, to effect all applications, notices, petitions and filings, and to obtain as set forth in CZFS Disclosure Schedule 4.11promptly as practicable all permits, since January 1consents, 2020, CZFS has timely filed with approvals and authorizations of all third parties and Governmental Entities which are necessary or advisable to consummate the SEC and NASDAQ all documents required transactions contemplated by this Agreement (including without limitation the Securities Act Merger and the Exchange Act Bank Merger). Beverly Corp. and such documentsSt. Paul shall have the right to review in advance, and to the extent practicable each will consult the other on, in each case subject to applicable laws relating to the exchange of information, all the information relating to Beverly Corp. or St. Paul, as the same case may have been amendedbe, compliedwhich appears in any filing made with, at the time filed or written materials submitted to, any third party or any Governmental Entity in connection with the SECtransactions contemplated by this Agreement; provided, in all material respects with the Securities Act and the Exchange Act. (c) Neither CZFShowever, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to nothing contained herein shall be deemed to be operating provide either party with a right to review any information provided to any Governmental Entity on a confidential basis in material violation connection with the transactions contemplated hereby. In exercising the foregoing right, each of the federal Bank Secrecy Act, parties hereto shall act reasonably and as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued promptly as practicable. The parties hereto agree that they will consult with each other with respect to anti-money laundering the obtaining of all permits, consents, approvals and authorizations of all third parties and Governmental Entities necessary or advisable to consummate the transactions contemplated by this Agreement and each party will keep the U.S. Department other apprised of the Treasury’s Office status of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) matters relating to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V contemplation of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundertransactions contemplated herein.

Regulatory Matters. INTERCARDIA shall own, control and shall retain legal responsibility for the preparation, filing and prosecution of all filings and applications required to obtain all Regulatory Approvals to commercially sell and use the Licensed Products in the INTERCARDIA Territory. OPOCRIN shall supply INTERCARDIA with any materials OPOCRIN possesses prepared in connection with but not limited to the promotion, packaging, manufacture, adverse event experience or other activities related to the Licensed Compound or Licensed Products in order to prosecute, complete or maintain any and all Regulatory Approvals, filings or submissions required by any regulatory authority. It is the intention of INTERCARDIA to file for Regulatory Approval in all major markets during the term of this Agreement. The decision as to timing of any such filing or the decision not to file in any market shall be in the sole and absolute discretion of INTERCARDIA. (a) Each of CZFS, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority Upon Regulatory Approval in the regular course INTERCARDIA Territory by each country's regulatory authority, INTERCARDIA's obligation to maintain such Regulatory Approval shall be subject to INTERCARDIA's or its Licensee's economic analysis of the business any such country's revenue potential, in such party's sole discretion. INTERCARDIA will promptly notify OPOCRIN of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or decisions relating to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettersuch Regulatory Approval affected by INTERCARDIA's economic analysis. (b) Other than as set forth in CZFS Disclosure Schedule 4.11During the term hereof each party shall within 48 hours of notice thereof furnish to the other party information concerning serious side effects, since January 1, 2020, CZFS has timely filed with life threatening effects or unexpected consequences attributable to the SEC and NASDAQ all documents required by Licensed Compound or the Securities Act and Licensed Products. Each party shall report to the Exchange Act and such documents, as the same may have been amended, complied, other party any other side effects on an annual basis at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Actmutually agreeable times. (c) Neither CZFSUpon request, FCCB nor the requesting party shall from the date of such request receive from the other party copies of all correspondence with, and all documents and applications filed with or submitted by any regulatory authority in each party's Territory with respect to the Licensed Compound or the Licensed Products including but not limited to copies of their respective properties is a all label statements, expert summaries and any information not previously included in any applications for Regulatory Approvals. Such copies of the aforementioned correspondence and documentation shall be sent to the receiving party within 30 days of submission to or is subject to any Regulatory Order receipt from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderregulatory authority. (d) Neither CZFS nor FCCB is a Each party shall within 30 days of notice thereof provide to any agreement with any individual or group regarding CRA matters the other party all data and neither CZFS nor FCCB documents to which each party has any Knowledge of, nor has CZFS or FCCB been advised access in writing order to support the compilation of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, registration dossiers and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereundersubsequent Regulatory Approvals.

Regulatory Matters. (a) Each Schedule 5.8 contains a list of CZFSall Product Regulatory Approvals. The Product has been Exploited in accordance with the specifications and standards contained in the Product Regulatory Approvals in all material respects and has otherwise been Manufactured and Exploited in accordance with all applicable Laws in all material respects. The Product Regulatory Approvals are in full force and effect, CZFSAC and FCCB have been validly issued to Seller, and Seller has timely filed complied in all reportsmaterial respects with all terms and conditions thereof. Seller has not received written notice relating to the revocation, registrations withdrawal, suspension, cancellation, termination or modification of any Product Regulatory Approval and, to Seller’s Knowledge, there are no circumstances currently existing that might reasonably be expected to lead to any withdrawal of, loss of or refusal to renew any Product Regulatory Approval. No Proceeding is pending or, to Seller’s Knowledge, threatened regarding the suspension or revocation of any Product Regulatory Approval. Seller has made available to Buyer complete and statements, together with correct copies of all the Product Regulatory Approvals. Seller is the sole and exclusive owner of the Product Regulatory Approvals. No right of reference has been granted to any amendments required to be made Person with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterProduct Regulatory Approvals. (b) Other than Neither the FDA nor any other Governmental Authority is (i) contesting the investigational use of, manufacture of, approval of, the uses of, or the labeling or promotion of the Product or (ii) otherwise alleging any violation by Seller of any applicable Law in connection with the Product, or (iii) asserting that any of the Product Regulatory Approvals are not currently in good standing with the FDA. (c) Neither Seller, nor, to Seller’s Knowledge, any of its Representatives, has made an untrue statement of material fact or fraudulent statement to any Governmental Authority with respect to the Product or failed to disclose a material fact required to be disclosed to any Governmental Authority with respect to the Product. As required under Law, Seller maintained, filed or furnished to the applicable Governmental Authority or Person all material registrations, listings, filings, documents, statements, claims, reports, notices, supplemental applications and annual and other reports and submissions, including adverse experience reports (collectively “Product Reports”) required to be maintained, filed or furnished on a timely basis with respect to the Product, the Product Regulatory Approvals, the Transferred Assets. At the time of filing or furnishing, all such Product Reports were true, complete and accurate in all material respects, or were subsequently updated, changed, corrected or modified, and to the extent required to be updated, as set forth so updated, remain true, accurate and complete in CZFS Disclosure Schedule 4.11all material respects, and no material deficiencies have been asserted by any such Governmental Authority with respect to such Product Reports. Neither Seller nor any of its Representatives, is or, since January 1, 2020, CZFS has timely filed been the subject of any pending or, to Seller’s Knowledge, threatened Proceeding pursuant to the FDA’s Application Integrity Policy or otherwise resulting from any other untrue, fraudulent, or false statement or omission with respect to the Business. (d) Seller has delivered to Buyer copies of any (i) reports of the FDA Form 483 inspection observations, (ii) establishment inspection reports, (iii) warning letters, and (iv) other documents that assert ongoing lack of compliance in any material respect with the SEC FDCA, received by Seller from the FDA or any equivalent foreign Governmental Authority, in each case (clauses (i) through (iv)) relating to the Product and/or arising out of the conduct of the Business. With respect to the Product, Seller has not received or been subject to, since January 1, 2020, any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other similar written notices or correspondence from any Governmental Authority, and NASDAQ all documents there is no adverse Proceeding pending or, to Seller’s Knowledge, threatened by any such Governmental Authority, related to the investigation, the approval, Exploitation, Manufacture, testing, processing, packaging, repackaging, stability, storage, labeling, relabeling, promotion, or distribution of the Product, or otherwise alleging any violation of Law with respect to the Product or the conduct of the Business except as where such notice, correspondence, or Proceeding would not be, individually or in the aggregate, material to the Product or the conduct of the Business. (e) All reports related to the Product required by the Securities Act FDA, including serious adverse event reports, have been submitted to the FDA. There have been no recalls, market withdrawals, field notifications or seizures requested, ordered or threatened or any adverse regulatory actions taken or threatened against Seller by the FDA or any other Governmental Authority with respect to the Product, including any facilities where the Product is researched, investigated, tested, Manufactured, produced, processed, packaged, or stored. Seller has not, either voluntarily or at the request of any Governmental Authority, initiated or participated in a recall, market withdrawal or field notification of the Product or provided any post-sale warnings regarding the Product. Seller has not received any written notice since January 1, 2020 through the date hereof, that any Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke, deny or withdraw any Product Regulatory Approval or other marketing authority of a Product, or request the recall, market withdrawal, field notification, removal or replacement of any Product, (ii) commenced, or threatened to initiate, any action to seize any Product or enjoin the research, development, investigational use, Manufacture, testing, processing, packaging, labeling, repackaging, relabeling, storage or Exploitation of any Product, or (iii) commenced, or threatened to initiate, any action to seize any Product or enjoin the research, development, investigation, Manufacture, testing, processing, packaging, labeling, repackaging, relabeling, storage or Exploitation of any Product produced at any facility where any Product is researched, developed, investigated, Manufactured, tested, processed, packaged, labeled, repackaged, relabeled, stored or held for Exploitation. (f) Since January 1, 2020, Seller has not received written notice of any (i) regulatory inspections of any facility in which the Product is researched, investigated, tested or Manufactured, or (ii) correspondence from any Governmental Authority, asserting that the research, investigational, testing or manufacturing operations of any facilities in which the Product is researched, investigated, tested or Manufactured are not in compliance in all material respects with all applicable Laws. Since January 1, 2020, with respect to the Product and the Exchange Act facilities in which the Product is researched, investigated, Manufactured, tested, processed, packaged, repackaged, labeled, relabeled or stored, Seller has not received or been subject to any untitled letters or, to Seller’s Knowledge, oral communication or correspondence, in each case from the FDA or any other Governmental Authority alleging that the Product or the facilities (specifically as related to the Product) in which the Product is researched, investigated, tested, Manufactured, packaged, labeled or stored are or were in violation of any Law or any applicable clearance, Permit, exemption, guidance or guideline, or alleging that the Product or the other facilities in which the Product is researched, investigated, tested, Manufactured, packaged, labeled or stored are or were the subject of any pending, threatened or anticipated Proceeding by a Governmental Authority. Since January 1, 2020, the Product has been Manufactured in compliance in all material respects with applicable Law, including Good Manufacturing Practice, and such documentsapplicable Product Regulatory Approvals. (g) Seller has not received or otherwise learned of any material complaints, as information or other adverse outcomes related to the same may have been amendedProduct. (h) Since January 1, complied2020, at Seller has not received any material written information from any Governmental Authority which would reasonably be expected to lead to the time filed revocation, withdrawal, or denial of any Product Regulatory Approval or Federal Health Care Program contract with respect to the SEC, Business or the Product. (i) All drug distribution activities with respect to the Product are in compliance in all material respects with the Securities Act Drug Supply Chain Security Act, including requirements for registration, reporting, licensing, drug listing, product tracing and the Exchange Actidentification, and systems for verification and handling of suspect or illegitimate product. (cj) Neither CZFSNone of the employees of Seller or, FCCB nor to Seller’s Knowledge, any manufacturer of their respective properties is a party to the Product have been disqualified or is subject to disqualification proceeding under 21 C.F.R. § 312.70 or suspended (or applicable foreign equivalent), or debarred by the FDA or subject to debarment proceedings under 21 U.S.C. § 335a (or applicable foreign equivalent) for any Regulatory Order from any Governmental Authority purpose, or have been excluded, charged with or convicted under the supervision U.S. federal law for conduct relating to the development or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised byapproval, or has otherwise relating to the regulation, of any Knowledge of facts which could give rise to an advisory notice bydrug product under the FDCA, Federal Health Care Programs or any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Orderother relevant Law. (dk) Since January 1, 2020, with respect to the Product and the Business, Seller has been in compliance with the requirements of Federal Health Care Programs, requirements relating to the Veterans Healthcare Act of 1992, and requirements relating to sales to 340B Program entities, in all material respects. (l) Neither CZFS nor FCCB is Seller nor, to Seller’s Knowledge, any of its Representatives has, with respect to the Product, (i) presented or caused to be presented a party claim for reimbursement for services to any agreement with Governmental Authority, including any Federal Health Care Program, that is false, (ii) knowingly offered, paid, solicited, or received any remuneration (including any kickback, bribe, rebate, or fee), overtly or covertly, in cash or in kind: (A) in return for referring any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data a Person for the year ended December 31, 2021, filed with furnishing or arranging for the FDICfurnishing of any item or service for which payment may be made in whole or in part by a Federal Health Care Program, or otherwise(B) to secure any improper advantage or to obtain or retain business that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not the Business to be in satisfactory compliance with violation of any Law, including the CRAfederal Anti- Kickback Statute (42 U.S.C. § 1320a-7b), and (iii) otherwise given, received, offered to pay to or solicited any remuneration from, in cash or kind, directly or indirectly, any past or present patient, customer, physician, other healthcare provider, supplier, vendor, contractor, Federal Health Care Program or other government program, including the regulations promulgated thereunderfederal Anti-Kickback Statute (42 U.S.C. § 1320a-7b), or (iv) knowingly made or caused to be assigned made or induced or sought to induce the making of any false statement or representation (or omitted to state a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) material fact required to be deemed to be operating stated therein) in material violation of order that any past or present patient, customer, physician, other healthcare provider, supplier, vendor, or contractor may receive reimbursement from a Federal Health Care Program or government program or in order that the federal Bank Secrecy ActBusiness may collect reimbursement from a Governmental Authority or Federal Health Care Program, as amendedin each case (clauses (i) through (iv)). (m) All research, clinical studies and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued pre-clinical studies in which Sxxxxx has participated with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be Product were conducted in material compliance accordance with all applicable Laws and regulation, including Good Laboratory Practice and Good Clinical Practices. There is no research, clinical study or pre-clinical study currently being conducted in which the applicable requirements contained Product is participating. (n) With respect to the Product, Seller has paid all fees described in any federal Section 9008 of the Patient Protection and state privacy or data security laws Affordable Care Act, Pub. L. No. 111-148, as amended by Section 1404 of the Health Care and regulationsEducation Reconciliation Act of 2010, including, without limitationPub. L. No. 111-152, in Title V of each case related to the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderProduct.

Regulatory Matters. (a) Each of CZFSThere are no disputes pending or, CZFSAC to Seller's Knowledge, threatened between Seller and FCCB has timely filed all reports, registrations and statements, together with any amendments required Regulatory Authority that (i) would reasonably be expected to prevent or materially delay Seller from being able to perform its obligations under this Agreement (ii) would reasonably be made with respect thereto, that it was required expected to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course prevent or materially delay Purchaser's receipt of the business Regulatory Approval or (iii) would reasonably be expected to impair the validity or consummation of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, this Agreement or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or bettertransactions contemplated hereby. A 75499905.9 22 (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with Neither Seller nor any of its Affiliates have received any oral or written indication from any Regulatory Authority that such agency would oppose or refuse to grant the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActRegulatory Approval. (c) Neither CZFSExcept as set forth in Section 5.6(c) of the Seller Disclosure Schedule, FCCB neither Seller nor any of their respective properties is its Affiliates are a party to any written order, decree, agreement or is subject to memorandum of understanding with, or commitment letter or similar submission to, any Regulatory Order from any Governmental Authority federal or state regulatory agency or authority charged with the supervision or regulation of financial institutions or issuers depository institutions, nor have any of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has them been advised by, by any such agency or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority authority that such Governmental Authority agency or authority is contemplating issuing or requesting (any such order, decree, agreement or is considering the appropriateness memorandum of issuing or requesting) any Regulatory Orderunderstanding. (d) Neither CZFS Seller is an insured depository institution rated “Satisfactory” or “Outstanding” for performance under the Community Reinvestment Act of 1977, as amended (the “CRA”), following its most recent CRA performance examination by a Regulatory Authority. Seller has neither been informed that its current rating or that of any insured depository institution Affiliate will or may be lowered in connection with a pending or future examination for CRA performance nor FCCB is a party to does Seller have Knowledge of the existence of any agreement with any individual fact or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS circumstance or FCCB been advised in writing set of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS that could reasonably be expected to result in Seller or FCCB: any of its insured depository institution Affiliates having its current rating lowered. (ae) to be deemed not to be in satisfactory At the time of the most recent regulatory evaluation of the Seller's compliance with anti-money laundering laws, including the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and OFAC regulations, Seller was found to be, and remains, in compliance with such laws. (f) To Seller's Knowledge, as of the regulations promulgated thereunderdate hereof, neither Seller nor any of its Affiliates have been informed by any state Regulatory Authority that a physical branch or other facility is required to be established within its geographical boundaries in order issued to conduct the Transferred Activities within such jurisdiction. (g) Since January 1, 2010, Seller and its Affiliates have complied in all material respects with respect all applicable laws and their respective internal privacy policies relating to anti-money laundering the privacy of customers of the Transferred Activities and users of products and services offered by the U.S. Department Transferred Activities and all Internet websites owned, maintained or operated by Seller and its Affiliates in connection with the operation of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderTransferred Activities.

Regulatory Matters. (ai) Each To each of CZFSthe Seller Parties’ Knowledge, CZFSAC each of the Seller Parties has each duly filed with the appropriate Governmental Authorities in substantially correct form the monthly, quarterly and FCCB has timely filed all reports, registrations and statements, together with any amendments annual reports required to be made with respect thereto, that filed by it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in under applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or better. (b) Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, reports were in all material respects complete and accurate and in material compliance with the Securities Act requirements of applicable laws and regulations, and the Exchange ActSeller Parties have previously delivered or made available to Purchaser Parties accurate and complete copies of all such reports. Except as Previously Disclosed, in connection with the most recent examinations of Seller Parties by the appropriate Governmental Authorities, the Seller Party was not required to correct or change any action, procedure or proceeding which Seller Party believes in good faith has not been now corrected or changed. (cii) Neither CZFSExcept as Previously Disclosed, FCCB nor none of the Seller Parties or any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision order, decree, directive, agreement, memorandum of understanding or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised bysimilar arrangement with, or a commitment letter or similar submission to, or extraordinary supervisory letter from, nor has any Knowledge of facts which could give rise to an advisory notice bythe Seller Parties adopted any policies, procedures or board resolutions at the request or suggestion of, any Governmental Authority that such Authority. Each Seller Party has paid all material assessments made or imposed by any Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderAuthority. (diii) Neither CZFS nor FCCB Except as Previously Disclosed or as otherwise made available, no Seller Party is a party subject to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB no Governmental Authority has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended initiated since December 31, 20212008 or has pending any proceeding, filed with enforcement action, capital directive or, to the FDICKnowledge of any of the Seller Parties, investigation or otherwiseinquiry into the business, operations, policies, practices or disclosures of any Seller Party (other than normal examinations conducted by a Governmental Authority in the ordinary course of the business of Seller Parties, or, to the Knowledge of any of the Seller Parties, threatened any of the foregoing. (iv) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) The most recent regulatory rating given to be deemed not SL Bank as to be in satisfactory compliance with the CRA, and Community Reinvestment Act is “needs improvement.” Since the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by last regulatory examination of SL Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets ControlCommunity Reinvestment Act compliance, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that SL Bank has not been deemed ineffective by received any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT complaints as to Community Reinvestment Act and the regulations thereunder.compliance. 3266.019/439907.1

Regulatory Matters. (a) Each of CZFSExcept as would not have a material impact on the Business, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority(i) the Acquired Companies are, and has paid since December 31, 2016 have been, in compliance with all fees Healthcare Laws applicable to the Acquired Companies and assessments due the Business, (ii) the research, development, design, manufacture and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course testing of the business Acquired Companies Products by or on behalf of CZFSthe Acquired Companies is being, CZFSAC and/or FCCBand since December 31, no Governmental Authority has initiated any proceeding2016 have been, or conducted in compliance with all applicable Healthcare Laws and (iii) the Acquired Companies are, and since December 31, 2016 have been, in compliance with all registration and listing requirements to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in extent required by applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterHealthcare Laws. (b) Other than Except as set forth would not have a material impact on the Business, each of the Acquired Companies (i) holds, and since December 31, 2016 have held, such Permits necessary or advisable for the design, development, pre-clinical and clinical testing of the Acquired Companies Products in CZFS Disclosure Schedule 4.11any jurisdictions where it currently conducts such activities with respect to each Acquired Company Product (collectively, the “Acquired Companies Licenses”) and (ii) is, and since January 1December 31, 2020, CZFS 2016 has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SECbeen, in compliance with all material respects with the Securities Act terms and the Exchange Actconditions of any Acquired Company License. (c) Neither CZFSSince December 31, FCCB nor any 2016, there have been no adverse regulatory Actions taken (or, to the Knowledge of their respective properties is a party to or is subject to any Regulatory Order from Seller, threatened) by any Governmental Authority charged with respect to any of the supervision Acquired Companies Products or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that facilities where such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory OrderAcquired Companies Products are tested. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters The Acquired Companies are not, and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended since December 31, 20212016 have not been, filed with the FDICsubject of any pending or, to the Knowledge of Seller, threatened investigation regarding the Acquired Companies or the Acquired Companies Products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46,191 (September 10, 1991) and any amendments thereto (“FDA Fraud Policy”), or otherwise) that . Neither the Acquired Companies, nor, to the Knowledge of Seller, any facts officer or circumstances existemployee of the Acquired Companies has made an untrue statement of material fact to any Governmental Authority, which would cause CZFS or FCCB: (a) failed to disclose a material fact required to be deemed not disclosed to any Governmental Authority, that, at the time such disclosure was made, would reasonably be expected to provide a basis for any Governmental Authority to invoke the FDA Fraud Policy or any similar policy in satisfactory compliance with any country. Neither the CRAAcquired Companies nor, and to the regulations promulgated thereunderKnowledge of Seller, any officer or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation employee of the Acquired Companies, has been convicted of any crime for which such Person could be excluded from participating in the federal Bank Secrecy Acthealth care programs under Section 1128 of the Social Security Act of 1935, as amended, and its implementing regulations (31 C.F.R. Chapter X), or any similar Law. The Acquired Companies have not received any written notice that any of their employees is included on the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering List of Excluded Individuals/Entities maintained by the U.S. Office of Inspector General of the United States Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal Health and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderHuman Services.

Regulatory Matters. (a) Each Seller, or an Affiliate of CZFSSeller, CZFSAC and FCCB has timely filed all reports, registrations and statements, together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authoritypossesses, and during the [***] years prior to the Execution Date has paid possessed, or has a right of reference to all fees material Regulatory Approvals necessary to conduct the Product Business as currently or then conducted or develop the 2.5 mg Dosage Strength or [***] Product in the Buyer Territory and assessments due the Regulatory Approvals necessary to conduct the Product Business in the Buyer Territory as currently conducted or to develop the 2.5 mg Dosage Strength or [***] Product in the Buyer Territory as currently being developed are in full force and payable in connection therewitheffect. Except for normal examinations conducted by During the [***] years prior to the Execution Date, neither Seller nor its Affiliates have received any written communication from any Governmental Authority in threatening to revoke, withdraw, modify, suspend, cancel or terminate any such Regulatory Approvals. No proceeding is pending or, to Seller’s Knowledge, threatened regarding the regular course suspension or revocation of any such Regulatory Approval. During the business of CZFS[***] years prior to the Execution Date, CZFSAC and/or FCCB, no Seller has not received any written notice that the FDA or any other Governmental Authority has initiated any proceedingcommenced, or threatened to initiate, any action to request a recall of the Product, or commenced, or threatened to initiate, any action to enjoin production at any facility at which the Product is Manufactured. Seller has not voluntarily or involuntarily surrendered, terminated or permitted to lapse or expire any Regulatory Approval used or maintained by Seller in the conduct of the Product Business or the development of the 2.5 mg Dosage Strength or [***] Product in the Buyer Territory, except where any such Regulatory Approval has been not renewed in the ordinary course of business. During the [***] years prior to the Knowledge Execution Date, Seller or its Affiliates have timely filed with the applicable Governmental Authority all required filings, declarations, listings, registrations, reports or submissions that are material to conduct of CZFSthe Product Business and the development of the [***] Product in the Buyer Territory, investigation into the business including adverse event reports. All such filings, declarations, listings, registrations, reports or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined submissions were in compliance in all material respects with all applicable laws and regulationsLaws when filed, and FCCB has a Community Reinvestment Act rating no material deficiencies have been asserted by any applicable Governmental Authority with respect to any such filings, declarations, listings, registrations, reports or submissions. Neither Seller nor its Affiliates is in violation of “satisfactory” the terms of any Regulatory Approval related to the Product, the 2.5 mg Dosage Strength or better[***] Product. (b) Other than During the [***] years prior to the Execution Date, there has not been any product recall, dear doctor letter or market withdrawal or replacement conducted by or on behalf of Seller concerning the Product in the Buyer Territory or any product recall, dear doctor letter, market withdrawal or replacement conducted by or on behalf of any Third Party as set forth a result of any alleged defect in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS the Product in the Buyer Territory. Seller has timely filed made available to Buyer true and correct summary reports regarding material complaints and notices of alleged defect or adverse reaction with respect to the SEC and NASDAQ all documents required by Product in the Securities Act and the Exchange Act and such documents, as the same may Buyer Territory that have been amendedreceived in writing by Seller and its Affiliates during the [***] years prior to the Execution Date,. (c) During the [***] years prior to the Execution Date, compliedthe Product in the Buyer Territory has been Manufactured in compliance with applicable Law, at including cGMP, and applicable Regulatory Approvals. (d) The (i) Phase IV clinical trials required pursuant to the time filed Phase IV Commitments for the Product being conducted by or on behalf of Seller or its Affiliates and (ii) the 2.5 mg Clinical Trials, in each case ((i) and (ii)), are being conducted in all material respects in accordance with cGCP and all applicable Laws. Seller and its Affiliates have made all necessary material filings and received all necessary material approvals and consents for the SECconduct of such Phase IV clinical trials and 2.5 mg Clinical Trials from the necessary Governmental Authorities and, to Seller’s Knowledge, there is no Litigation pending or threatened by such Governmental Authorities to suspend or terminate any ongoing clinical trials for the Product or the 2.5 mg Dosage Strength in the Buyer Territory. Seller has not received any written notice, charge, subpoena or other request for information, which has not been complied with or withdrawn, by a Governmental Authority asserting any material breach of the conditions for approval of any ongoing clinical trials for the Product or the 2.5 mg Dosage Strength in the Buyer Territory. Seller and its Affiliates have conducted all Phase IV clinical trials required pursuant to the Phase IV Commitments for the Product in the Buyer Territory and all 2.5 mg Clinical Trials pursuant to valid protocols. (e) Seller has calculated and reported all prices reported to or used to calculate pricing or discounts under the Medicaid Program (42 U.S.C. § 1396r-8), the 340B Drug Discount Program (42 U.S.C. § 256b), and Section 603 of the Veterans Healthcare Act of 1993 (Pub. L. 102-585) for the Product in compliance in all material respects with the Securities Act and the Exchange Actapplicable Law. (c) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.

Regulatory Matters. (a) Each Prior to the NDA Transfer Date. The Parties acknowledge that Indevus has obtained FDA Approval for Trospium Twice-Daily and Trospium Once-Daily and is the owner of CZFSthe Product NDAs as of the Execution Date and is expected to be the owner of the Product NDAs as of the Effective Date. Prior to the NDA Transfer Date: (i) Indevus shall own and control all Regulatory Documents relating to a Product in the Field in the Territory. (ii) Indevus shall have sole authority and responsibility for the timely preparation, CZFSAC filing, prosecution, and FCCB has timely filed maintenance of all reportsRegulatory Documents relating to a Product in the Field in the Territory, registrations including Product NDAs and statementsany reports or amendments necessary to maintain FDA Approvals, together and for seeking any revisions of the conditions of each FDA Approval. (iii) Indevus shall have sole authority and responsibility to seek and/or obtain any necessary FDA approvals of any Product Label(ing), packaging, advertising or other promotional or informational materials used in connection with Product and Promotional Materials and for determining whether the same requires FDA approval, and Indevus shall submit Promotional Materials to the FDA after approval of both Parties, in accordance with the procedures set forth in Section 5.6. (iv) Indevus shall remain the primary contact with the FDA and shall be solely responsible for all communications with the FDA that relate to any IND or NDA relating to a Product in the Field in the Territory prior to and after any FDA Approval. (v) Esprit shall have the right, but not the obligation, to assist and consult with Indevus with respect to all regulatory submissions, including applications for FDA Approvals, prior to making any such submissions. At least thirty (30) days prior to the filing of any documents with the FDA relating to Products in the Field, Indevus shall provide Esprit with copies of all such filings, submissions, authorizations and FDA Approvals, including any correspondence related to manufacturing of Products in the Field; provided that, if Indevus believes it is required by Law to make such submission sooner, Indevus shall provide Esprit with final copies of such submissions for Esprit’s review at least two (2) Business Days prior to filing them with the FDA. Indevus shall consider in good faith any comments of Esprit with respect to the foregoing. (vi) Indevus shall provide Esprit with a copy of all safety data received by Indevus regarding Products in the Field worldwide. (vii) Indevus shall provide advance notice to Esprit of any planned meetings, discussions, or other communications with the FDA relating to Products in the Field. Esprit shall have the right, but not the obligation, to participate with respect to such meetings, discussions, or other communications; provided that, in providing any such assistance, Esprit shall not contact the FDA without the prior approval of Indevus and, if contacted by the FDA with respect to Product, shall refer such contact to Indevus. (viii) If contacted by the FDA with respect to a Product in the Field, Indevus shall notify Esprit within two (2) Business Days of such contact, and provide Esprit with any amendments related official correspondence received from the FDA, including as applicable minutes of any meetings or telephone conferences and/or discussions between Indevus and the FDA. Esprit shall have a right to participate in and provide comments with respect to any subsequent meetings, discussions, or other communications with respect to such contact. (ix) To the extent Esprit reasonably believes that a filing or submission relating to Products in the Territory is required by Law, Esprit shall notify Indevus. If Indevus decides not to prepare such filing or submission, Indevus shall promptly notify Esprit, but in no event later than thirty (30) days, unless notified by Esprit that a shorter period of review is mandated by FDA or Law, after such notice by Esprit of such decision, and Esprit shall be entitled to prepare such filing or submission, to be filed or submitted by Indevus; provided that Esprit shall use good faith efforts to include any comments of Indevus in such filing or submission. (x) Prior to the Processing Assumption Date, changes to the Specifications shall be made only by mutual prior agreement of the Parties, except as required by Law. The Parties shall determine whether any such changes require any supplements to a Product NDA, and each Party shall provide the other Party with respect theretonotice of any such changes as soon as practicable. After the Processing Assumption Date, but prior to the NDA Transfer Date, changes to the Specifications shall be made only after prior notification to Indevus of any such changes as soon as practicable, and the Parties shall determine whether any such changes require any supplements to a Product NDA, except as required by Law. (xi) Notwithstanding anything herein to the contrary, Indevus shall not file with the FDA any regulatory submissions that it was are intended to change or modify the Product label or FDA-approved prescribing information for, or the indications of, Trospium Twice-Daily or Trospium Once-Daily in the Territory without providing to Esprit a draft of such submission at least ten (10) days prior to planned submission to the FDA and giving prompt and reasonable consideration to any comments Esprit may have; provided that, if and to the extent required by Law Indevus is required to file since January 1any such submission in less than ten (10) days after notice from the FDA, 2020 with Indevus will notify Esprit of any Governmental Authoritysuch requirement promptly and in no event later than two (2) Business Days after such notice. (xii) Notwithstanding Section 14.13(f), during the period beginning on the Processing Assumption Date and has paid all fees and assessments due and payable ending on the NDA Transfer Date, in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course with Indevus’ responsibilities as holder of the business Product NDAs, Indevus and Esprit shall cooperate in good faith, in coordination with the Supply Committee, for Indevus to subcontract or assign the performance and management of CZFSquality assurance responsibilities to Esprit, CZFSAC and/or FCCBwhile retaining the authority for Indevus to monitor Esprit’s performance, no Governmental Authority has initiated any proceedingas subcontractor to Indevus with respect to such activities, or to consistent with Indevus’ quality obligations under the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “wellProduct NDA for Trospium Once-capitalized” as defined in applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterDaily. (b) Other than After the NDA Transfer Date. After the NDA Transfer Date: (i) Esprit shall own and control all Regulatory Documents relating to a Product in the Field in the Territory. Indevus hereby assigns to Esprit all right, title and interest in such Regulatory Documents, effective as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with of the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange ActNDA Transfer Date. (cii) Neither CZFSEsprit will be solely responsible for the timely preparation, FCCB nor any filing, prosecution, and maintenance of their respective properties is all Regulatory Documents relating to a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged Product in the insurance Field in the Territory, including Product INDs and NDAs and any reports or amendments necessary to maintain FDA Approvals, and for seeking any revisions of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation conditions of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Ordereach FDA Approval. (diii) Neither CZFS nor FCCB is a party Esprit shall have sole authority and responsibility to develop, modify, seek and/or obtain any necessary FDA approvals of any Product Label(ing), packaging, advertising or other promotional or informational materials used in connection with Product in the Field in the Territory, and Promotional Materials and for determining whether the same requires FDA approval. (iv) Esprit will be the primary contact with the FDA and shall be solely responsible for all communications with the FDA that relate to any agreement with IND or NDA relating to a Product in the Field in the Territory prior to and after any individual FDA Approval. (v) Esprit may, in its sole discretion, file any submissions that are intended to change or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge modify the Product label or FDA-approved prescribing information for, or the indications of, nor has CZFS Trospium Twice-Daily or FCCB been advised Trospium Once-Daily in writing the Territory provided that, except as required by Laws, it provides to Indevus a draft of such submission at least ten (10) days prior to planned submission to the FDA and gives prompt and reasonable consideration to any comments Indevus may have. (vi) To the extent Indevus reasonably believes that a filing or has any reason submission relating to believe Products in the Field in the Territory is required by Law, Indevus shall notify Esprit. If Esprit decides not to prepare such filing or submission, it shall promptly notify Indevus, but in no event later than thirty (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 3130) days, 2021unless notified by Indevus that a shorter period of review is mandated by FDA or Law, filed with the FDICafter such notice by Indevus of such decision, and Indevus shall be entitled to prepare such filing or otherwise) that any facts or circumstances existsubmission, which would cause CZFS or FCCB: (a) to be deemed filed or submitted by Esprit; provided that Indevus shall use good faith efforts to include any comments of Esprit in such filing or submission. (vii) Indevus may, but is not to be in satisfactory compliance with the CRArequired to, and the regulations promulgated thereunderassist Esprit, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to anti-money laundering by the U.S. Department of the Treasuryat Esprit’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitationelection, in Title V Esprit’s efforts to seek and obtain FDA Approvals, subject to reimbursement of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 Indevus’ related costs and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunderexpenses.

Regulatory Matters. (ai) CANbridge or its Affiliate is the “local agent” listed in connection with the Marketing Authorization of the Licensed Product issued by NMPA in mainland China and CANbridge or its respective Affiliate is the Marketing Authorization holder of the Licensed Product in Taiwan and Hong Kong issued by the Taiwan Food and Drug Administration of Taiwan and the Pharmacy and Poisons Board of Hong Kong, respectively, in each case, that references PUMA’s Marketing Authorization approved by the FDA. (ii) Each Marketing Authorization, including each certificate or local agent status, issued or granted by the applicable Regulatory Authorities is in full force and effect. US-DOCS\121531884.1 (iii) CANbridge is the holder of CZFSall filings for Pricing and Reimbursement Approval in connection with the Licensed Products in the Territory as of the Effective Date. (iv) No litigation is pending or threatened regarding the revocation, CZFSAC cancellation, rescission, suspension, withdrawal, modification, or refusal to renew in the ordinary course any Marketing Authorization of the Licensed Products in the Territory, nor has any event occurred, to CANbridge’s knowledge, that would reasonably be expected to give rise to any right of notice, modification, acceleration, payment, cancellation, withdrawal, limitation, or termination of a Marketing Authorization issued by the Regulatory Authorities of mainland China, Hong Kong and FCCB Taiwan, respectively. (v) Neither CANbridge, any of its Affiliate, nor to CANbridge’s knowledge, any of its contractors or vendors under the Terminated Agreements and Documents have received any written communication from any Governmental Authority threatening to revoke, cancel, rescind, suspend, withdraw, modify, or refuse to renew any Marketing Authorization issued by the Regulatory Authorities of mainland China, Hong Kong and Taiwan, respectively, that has timely filed all reportsnot been withdrawn or otherwise remedied. (vi) Neither CANbridge, registrations any of its Affiliates, nor to CANbridge’s knowledge, any of its Sublicensees, contractors or vendors under the Terminated Agreements and statementsDocuments are in violation of the terms of any Marketing Authorization, together with including certificate of sale, of the Licensed Products issued by the Regulatory Authorities of mainland China, Hong Kong and Taiwan, respectively, or its rights as “local agent” in mainland China, Hong Kong and Taiwan, respectively. (vii) Neither CANbridge, any amendments required of its Affiliates, nor to be made CANbridge’s knowledge, any of its contractors or vendors under the Terminated Agreements and Documents have initiated an application for a Marketing Authorization, including a certificate of sale, with respect theretoto the Licensed Products in Macao and neither is aware of any information that would hinder the application for or the grant of such Marketing Authorization, including a certificate of sale. (viii) All fees and charges with respect to each Licensed Product Marketing Authorization, including a certificate of sale, as issued by the Regulatory Authorities of mainland China, Hong Kong and Taiwan, respectively, that it was required to file since January 1, 2020 with any Governmental Authority, and has paid all fees and assessments have become due and payable have been paid in connection therewith. Except for normal examinations conducted by full, and all required applications, notices, and required filings (including any pending renewal applications, notices, or filings) with respect to such Marketing Authorizations, including a certificate of sale, have been duly filed or made on a timely basis with the appropriate Governmental Authorities. (ix) Neither CANbridge, any of its Affiliates nor, to CANbridge’s knowledge, any Sublicensees or Third Party contractors under the Terminated Agreements and Documents have been subject to physical inspections or received inspection reports from any applicable Governmental Authority in the regular course of the business of CZFSTerritory, CZFSAC and/or FCCB, no in which such Governmental Authority has initiated any proceeding, asserted or to alleged that the Knowledge of CZFS, investigation into the business or operations of CZFSCANbridge, CZFSAC and/or FCCBany of its Affiliates, since January 1, 2020. FCCB is “well-capitalized” as defined Sublicensees or any Third Party contractors were or are not in compliance with any applicable laws and regulations, and FCCB has a Community Reinvestment Act rating of “satisfactory” or betterLaws. (bx) Other than There has not been any claim for injury or property damage as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by the Securities Act and the Exchange Act and such documents, as the same may have been amended, complied, at the time filed with the SEC, in all material respects with the Securities Act and the Exchange Act. a result of any defect or other deficiency (cwhether of design or materials) Neither CZFS, FCCB nor any of their respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the FRB) or the supervision or regulation of it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority that such Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of issuing or requesting) any Regulatory Order. (d) Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as amended, and its implementing regulations (31 C.F.R. Chapter X), the USA PATRIOT Act, and the regulations promulgated thereunder, any order issued with respect to antiany Licensed Product used or sold by or on behalf of CANbridge in the Territory, and to CANbridge’s knowledge, there is no fact or circumstance that may lead to such claim. US-money laundering by the U.S. Department of the Treasury’s Office of Foreign Assets Control, or any other applicable anti-money laundering statute, rule or regulation; or (c) to be deemed not to be in material compliance with the applicable requirements contained in any federal and state privacy or data security laws and regulations, including, without limitation, in Title V of the Xxxxx-Xxxxx-Xxxxxx Act of 1999 and regulations promulgated thereunder, as well as the provisions of the information security program adopted by CZFS pursuant to 12 C.F.R. Part 000, Xxxxxxx X, Xxxxxxxx D. Furthermore, the CZFS Board has adopted and CZFS has implemented an anti-money laundering program that contains adequate and appropriate customer identification verification procedures that has not been deemed ineffective by any Governmental Authority and that meets the requirements of Sections 352 and 326 and all other applicable provisions of the USA PATRIOT Act and the regulations thereunder.DOCS\121531884.1