Common use of Regulatory Matters Clause in Contracts

Regulatory Matters. The preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) were, or if still pending are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus Registration Statement, the General Disclosure Package and the Final Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, being conducted in all material respects in accordance with experimental protocolsall applicable statutes, rules, regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; the Company has not received received, nor does it have knowledge after due inquiry that any notices of its collaboration partners has received, any written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the a Company Studies and TrialsTrial. In using or disclosing patient information received by the Company in connection with the a Company Studies and TrialsTrial, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. Pre-Clinical Studies and Clinical Trials. The preclinical tests or studies or clinical trials and nonclinical, also known as pre-clinical, studies conducted by or or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the Company, or in which the Company or its product candidates have participated, that are described in the Prospectus (Registration Statement, the “Company Studies Pricing Disclosure Package and Trials”) the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, or and if still pending are beingare, being conducted in all material respects in accordance with the experimental protocols, procedures protocols and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the ProspectusFDCA for all such pre-clinical studies or clinical trials and all Health Care Laws of the Regulatory Authorities; the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of the Company Studies and Trials contained in the Prospectus such clinical trials, or pre-clinical studies are accurate in all material respectsand complete and fairly present the data derived from such trials or studies; the Company has no Knowledge knowledge of any other studies or clinical trials not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; and neither the Company has not nor any of its subsidiaries have received any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, modification or suspension or material modification of any Company Studies proposed or Trials ongoing clinical trials or pre-clinical studies that terminationare described in the Registration Statement, suspension the Pricing Disclosure Package and the Prospectus or material modification would reasonably be expected the results of which are referred to have a Material Adverse Effect in the Registration Statement, the Pricing Disclosure Package and the Prospectus, other than ordinary course communications with respect to modifications in connection with the design and implementation of such clinical trials or pre-clinical studies, and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (; and no investigational new drug application or caused to be obtained) informed consent comparable submission filed by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who FDA has been disqualified as a clinical investigator terminated or has been found suspended by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateor any other Regulatory Authority.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus Registration Statement, the General Disclosure Package and the Final Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, being conducted in all material respects in accordance with experimental the protocols, procedures and controls pursuant todesigned and approved for such studies and with all applicable statutes, where applicablerules, accepted professional regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific standardsresearch procedures and any applicable rules, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has and its subsidiaries have no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus; and the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; neither the Company nor its subsidiaries have received, nor does the Company or its subsidiaries have knowledge after due inquiry that any of its collaboration partners has not received received, any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies or Trials that terminationTrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeand its subsidiaries’ knowledge, there are no reasonable grounds for the same. The Company has and its subsidiaries have obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the a Company Studies and TrialsTrial. In using or disclosing patient information received by the Company or its subsidiaries in connection with the a Company Studies and TrialsTrial, the Company has and its subsidiaries have complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Change and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date extent such parties are subject to the statures, rules regulation and (2) policies of the Company and its subsidiaries solely from and after FDA or comparable regulatory agency outside of the Share Exchange Closing DateUnited States.

Regulatory Matters. Clinical Trials. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, the General Disclosure Package and Final Prospectus are accurate in all material respects; the Company has no Knowledge is not aware of any other tests, studies or trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which are inconsistent with or reasonably call in into question the results of the tests, studies and trials described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, or suspension or material modification of any Company Studies or Trials and that such termination, or suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect, and, to the Company’s Knowledgeknowledge after reasonable investigation, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicablerules, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge after reasonable investigation, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated misconduct or debarred or excluded from participation in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateany governmental health care payment program.

Regulatory Matters. The preclinical studies and tests or studies or clinical trials conducted by or on behalf of or sponsored by the Company or its Subsidiaries that are described or referred to in the Registration Statement, any Preliminary Prospectus (and the “Company Studies and Trials”) wereProspectus were and, or if still pending pending, are being, being conducted in accordance in all material respects in accordance with experimental protocolsall statutes, procedures laws, rules and controls pursuant toregulations, where applicableas applicable (including, accepted professional scientific standardswithout limitation, except as described in those administered by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the Prospectus; the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Company Studies Registration Statement, any Preliminary Prospectus and Trials contained in the Prospectus are accurate and complete in all material respects; respects and fairly present the published data derived from such studies and tests, and each of the Company and its Subsidiaries has no Knowledge knowledge of any other studies or trials not described in the Prospectus, tests the results of which are materially inconsistent with or otherwise call in into question the results described or referred to in the Prospectus; Registration Statement, any Preliminary Prospectus and the Prospectus. Neither the Company nor its Subsidiaries has not received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental body exercising comparable or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing studies or tests requiring the termination, termination or suspension of such studies or material modification of any Company Studies or Trials that termination, suspension or material modification tests. Except as would not be reasonably be expected to have result in a Material Adverse Effect andEffect, neither the Company nor any of its Subsidiaries has failed to file with the Company’s Knowledgeapplicable regulatory authorities (excluding the FDA or any foreign, there are no reasonable grounds for federal, state or local governmental or regulatory authority performing functions similar to those performed by the same. The Company has obtained (FDA) any filing, declaration, listing, registration, report or caused submission that is required to be obtained) informed consent by or on behalf of each human subject who participated in so filed. Neither the Company Studies and Trials. In using nor any of its Subsidiaries has failed to file with the FDA or disclosing patient information received any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the Company FDA, any filing, declaration, listing, registration, report or submission that is required to be so filed. All such filings were in connection material compliance with the Company Studies applicable laws when filed and Trials, the Company has complied in all material respects with all laws and no deficiencies have been asserted by any applicable regulatory rules or requirements, in each case to the extent applicable, authority (including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s KnowledgeFDA or any foreign, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator federal, state or has been found local governmental or regulatory authority performing functions similar to those performed by the FDA FDA) with respect to have engaged in scientific misconduct. To the Company’s Knowledgeany such filings, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutesdeclarations, ruleslistings, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraphregistrations, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Datereports or submissions.

Regulatory Matters. The All studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures protocols and controls pursuant to, where applicable, accepted professional scientific standardsall applicable laws and regulations, except as described where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Prospectus; Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the descriptions Company or any of the results its Subsidiaries, and none of the Company Studies or any of its Subsidiaries has received any written notice, warning letter or other communication from the U.S. Food and Trials contained in Drug Administration (“FDA”), the Prospectus are accurate in all material respects; the Company has no Knowledge of U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) or any other studies governmental or trials not described in the Prospectusregulatory authority, the results of which are inconsistent with or call in question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring (i) requires the termination, suspension or material modification of any Company Studies or Trials that terminationTrials, suspension (ii) imposes a clinical hold on any clinical investigation by the Company or material modification any of its Subsidiaries, (iii) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (iv) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the sameEffect. The Company has obtained (or caused to be obtained) informed consent by or on behalf properties, business and operations of each human subject who participated in the Company Studies have been and Trials. In are being conducted in all material respects in accordance with all applicable laws, rules and regulations, and in using or disclosing patient information received by the Company Company, if any, in connection with the Company Studies and Trials, the Company has and its Subsidiaries have complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA FDA, the MHRA, or a comparable foreign regulatory authority to have engaged in scientific misconductmisconduct or violations of good clinical practices. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA FDA, the MHRA, and comparable foreign governmental or regulatory agencies outside of the United States authorities to which the Company is Company’s products are subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or Clinical Trials. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s products and product candidates, including any such studies and trials that are described in the Prospectus Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, being conducted in all material respects in accordance with experimental protocolsall applicable Health Care Laws, including, without limitation, Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received, nor does the Company have knowledge after due inquiry that any of its collaboration partners have received any notices written notices, correspondence or correspondence other communications from the FDA Applicable Regulatory Authorities or any foreign, state other Governmental Entity requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that termination, suspension trials. No investigational device exemption or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent comparable submission filed by or on behalf of each human subject who participated in the Company Studies and Trials. In using with the FDA has been terminated or disclosing patient information received suspended by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules FDA or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunderany other Applicable Regulatory Authority. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) were, or if still pending are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the ProspectusGeneral Disclosure Package; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or studies or clinical trials and pre-clinical studies conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the Registration Statement, the Disclosure Package and the Prospectus (or the “Company Studies results of which are referred to in the Registration Statement, the Disclosure Package and Trials”) werethe Prospectus, or as applicable, and are intended to be submitted to Regulatory Authorities as a basis for product approval, were and, if still pending pending, are being, being conducted in all material respects in accordance with experimental protocols, standard medical and scientific research procedures and controls pursuant toall applicable statutes, where applicablerules and regulations of the United States Food and Drug Administration (the “FDA”) and comparable drug regulatory agencies outside of the United States to which they are subject including but not limited to the Therapeutic Goods Administration of Australia and the European Medicines Agency (collectively, accepted professional scientific standards, except as described in the Prospectus“Regulatory Authorities”) and applicable current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Registration Statement, the Disclosure Package or the Prospectus of the results of the Company Studies such studies and Trials contained in the Prospectus trials are accurate and complete in all material respectsrespects and fairly present the data derived from such studies and trials; the Company has no Knowledge knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or otherwise call in into question the results described or referred to in the Registration Statement, the Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the FDA Regulatory Authorities and comparable regulatory agencies outside has not received any written notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency which could lead to the termination or suspension of any clinical trials or pre-clinical studies that are described in the United States to which the Company is subject. For purposes of this paragraphRegistration Statement, the Company Disclosure Package and its subsidiaries shall be deemed the Prospectus or the results of which are referred to refer to (1) Albireo Limited and its subsidiaries as they existed prior in the Registration Statement, Disclosure Package or the Prospectus, and, to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing DateCompany’s knowledge, there are no reasonable grounds for same.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or to the Company’s Knowledge on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the ProspectusGeneral Disclosure Package; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect andEffect, and to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests Company is in compliance with all statutes, rules or regulations of the FDA, the DEA, the EMA, the MHRA and other comparable governmental agencies engaged in the regulation of pharmaceutical drugs applicable to the ownership, testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export or disposal of any product under development, manufactured or distributed by the Company except where noncompliance would not, singularly or in the aggregate, have a Material Adverse Effect. The nonclinical studies or and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocolsall applicable federal, procedures state and controls pursuant toforeign laws, where applicablerules, accepted professional scientific standards, except as described in the Prospectusorders and regulations; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence from the FDA FDA, the DEA, the EMA, the MHRA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all federal, state, local or foreign applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunderthereunder (“HIPAA”). Neither the Company, nor its subsidiaries or any of their respective directors, officers, employees or, to the Company’s knowledge, agents is or since January 1, 2015 has been debarred, suspended or excluded or, to the knowledge of the Company, engaged in any conduct that would reasonably be expected to result in a debarment, suspension or exclusion from any federal or state government health care program or human clinical research. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator investigator, as such term is defined in Title 21, Section 50.3 of the U.S. Code of Federal Regulations, who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the FDA and FDA, the DEA, the EMA, the MHRA or comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; the Company has no Knowledge of any research misconduct or data fraud in any studies or clinical trials, the results of which the Company intends to include or reference in any regulatory submission for any product; and the Company has not received any written notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case related to the extent applicablepatient information, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical studies, tests or studies or and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and the Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental body authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that and Trials, which termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Effect, and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the FDA and comparable regulatory agencies governmental authorities outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall except as would not reasonably be deemed expected to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Datehave a Material Adverse Effect.

Regulatory Matters. The preclinical tests or Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus Registration Statement, the General Disclosure Package and the Final Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are, being conducted in accordance with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are beingbeing conducted, except where the failure to be in compliance or be so conducted would not reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in fairly present the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respectsdata derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies operated at all times and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA Regulatory Authorities; except as disclosed in the General Disclosure Package and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraphFinal Prospectus, the Company has not received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateimplementation of such studies or trials.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or to the Company’s Knowledge on behalf of the Company that are described in the Registration Statement or the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Registration Statement or the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement or the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the Registration Statement or the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect andEffect, and to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant tocontrols, where applicable, accepted professional scientific standards, except as described in the Prospectusincluding all applicable laws and regulations; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices from or had any other correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that for which termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company Company, if any, in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA or a comparable foreign regulatory authority to have engaged in scientific misconductmisconduct or violations of good clinical practices. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are, being conducted in accordance with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are beingbeing conducted, except where the failure to be in compliance or be so conducted would not reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the Time of Sale Prospectus or the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in fairly present the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respectsdata derived EAST\42430474.3 #90596650v4 therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies operated at all times and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of Regulatory Authorities; except as disclosed in the United States to which the Company is subject. For purposes of this paragraphProspectus, the Company has not received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateimplementation of such studies or trials.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Change and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or on behalf of the Company and its subsidiaries that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls (it being understood that minor protocol deviations that were immediately addressed via corrective action and that do not impact study integrity shall not be deemed material for purposes of this section) pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or clinical trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices notices, communications or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and TrialsTrials and all such clinical trials have been performed in compliance with generally accepted good clinical practices. In using or disclosing patient information received by To the Company in connection with the Company Studies and TrialsCompany’s Knowledge, the Company and each of its subsidiaries, and each of their respective directors, officers, employees and agents, is and has complied been in all material respects compliance with all laws and regulatory rules or requirementsapplicable health care laws, in each case including, to the extent applicable, including, without limitation, the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.), the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the criminal False Claims Law (42 U.S.C. § 1320a-7b(a)), the Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (42 U.S.C. § 17921 et seq.), the exclusion laws (42 U.S.C. § 1320a-7), Medicare (Title XVIII of the Social Security Act), Medicaid (Title XIX of the Social Security Act), and the rules Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Affordability Reconciliation Act of 2010, including without limitation the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h), and the regulations promulgated pursuant to such laws, comparable state laws, and comparable foreign laws and regulations thereunderin all foreign jurisdictions in which the Company does business (collectively, “Health Care Laws”). Neither the Company nor any of its subsidiaries has received notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from the FDA or any foreign, state or local governmental body exercising comparable authority alleging that any product operation or activity is in material violation of any Health Care Laws. The Company and each of its subsidiaries has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments thereto as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, no employee, consultant or agent is engaged in practices that are prohibited by the Foreign Corrupt Practices Act or similar foreign laws such as the U.K. Bribery Act, nor has any employee, consultant or agent violated such prohibitions in the past five (5) years. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is or its contractors and supplies are subject. For purposes of this paragraphTo the Company’s Knowledge, neither the Company nor any subsidiary is distributing or promoting any product in a way that would violate the advertising and promotional requirements of the FDA or any other federal, state or foreign regulatory authority, including the FDA’s current regulations and policies related to “off-label” marketing and promotion of medical devices to health care practitioners, meaning promotion of the device for uses that are not consistent with the current scope of its subsidiaries shall be deemed to refer to (1) Albireo Limited marketing authorization and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateproduct labeling.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and ​ ​ Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Change and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date extent such parties are subject to the statures, rules regulation and (2) policies of the Company and its subsidiaries solely from and after FDA or comparable regulatory agency outside of the Share Exchange Closing DateUnited States.

Regulatory Matters. The preclinical tests or Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are, being conducted in accordance with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are beingbeing conducted, except where the failure to be in compliance or be so conducted would not reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the Time of Sale Prospectus or the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in fairly present the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respectsdata derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies operated at all times and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of Regulatory Authorities; except as disclosed in the United States to which the Company is subject. For purposes of this paragraphProspectus, the Company has not received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateimplementation of such studies or trials.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or to the Company’s Knowledge on behalf of the Company that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Registration Statement or the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect andEffect, and to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The All studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures protocols and controls pursuant to, where applicable, accepted professional scientific standardsall applicable laws and regulations, except as described where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Prospectus; Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the descriptions Company or any of the results its Subsidiaries, and none of the Company Studies or any of its Subsidiaries has received any written notice, warning letter or other communication from the U.S. Food and Trials contained in Drug Administration (“FDA”), the Prospectus are accurate in all material respects; the Company has no Knowledge of U.K. Medicines and Healthcare Products Regulatory Agency (“MHRA”) or any other studies governmental or trials not described in the Prospectusregulatory authority, the results of which are inconsistent with or call in question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring (i) requires the termination, suspension or material modification of any Company Studies or Trials that terminationTrials, suspension (ii) imposes a clinical hold on any clinical investigation by the Company or material modification any of its Subsidiaries, (iii) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (iv) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the sameEffect. The Company has obtained (or caused to be obtained) informed consent by or on behalf properties, business and operations of each human subject who participated in the Company Studies have been and Trials. In are being conducted in all material respects in accordance with all applicable laws, rules and regulations, and in using or disclosing patient information received by the Company Company, if any, in connection with the Company Studies and Trials, the Company has and its Subsidiaries have complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA FDA, the MHRA, or a comparable foreign regulatory authority to have engaged in scientific misconductmisconduct or violations of good clinical practices. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA FDA, the MHRA, and comparable foreign governmental or regulatory agencies outside of the United States authorities to which the Company is Company’s products are subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company participated, with respect to the Company’s product and product candidates, including any such studies and trials that are described in the Prospectus Registration Statement, the General Disclosure Package and the Final Prospectus, or the results of which are referred to in the Registration Statement and the General Disclosure Package and the Final Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, to the Company’s knowledge being conducted in all material respects in accordance with experimental protocolsall applicable statutes, rules, regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus; to the Company’s knowledge, the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; the Company has not received received, nor does it have knowledge after due inquiry that any notices of its collaboration partners has received, any written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused Trials have been designed to be obtained) ensure that informed consent by or on behalf of from each human subject who participated participating in the Company Studies and TrialsTrials is obtained. In using or disclosing patient information received by the Company in connection with the a Company Studies and TrialsTrial, the Company has complied in all material respects respects, to the extent applicable, with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standardsstandards established by applicable law (e.g., except as described in the ProspectusGood Clinical Practice); the descriptions of the results of the Company Studies and Trials contained contained, or incorporated by reference, in the Registration Statement, the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case requirements that are applicable to its conduct of the extent applicable, including, without limitation, the Health Insurance Portability Company Studies and Accountability Act of 1996 and the rules and regulations thereunderTrials. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies governmental authorities outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus SEC Documents, or the results of which are referred to in the SEC Documents (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, being conducted in all material respects in accordance with experimental protocolsall applicable statutes, rules, regulations and policies of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions regulations and policies of the results of the Company Studies jurisdiction in which such trials and Trials contained in the Prospectus studies are accurate being conducted in all material respects; the descriptions in the SEC Documents of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the ProspectusSEC Documents, the results of which are inconsistent with or call in into question the results described or referred to in the ProspectusSEC Documents; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in contract research organizations conducting the Company Studies Trials have, operated at all times and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA Regulatory Authorities; and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of this paragraphCompany Trials, other than ordinary course communications with respect to modifications in connection with the Company design and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateimplementation of such studies or trials.

Regulatory Matters. The preclinical tests or Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are, being conducted in accordance with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are beingbeing conducted, except where the failure to be in compliance or be so conducted would not reasonably be expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the Time of Sale Prospectus or the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in fairly present the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respectsdata derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies operated at all times and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA Regulatory Authorities; except as disclosed in the General Disclosure Package and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraphFinal Prospectus, the Company has not received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateimplementation of such studies or trials.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described or in which the Prospectus Company’s product candidates participated (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectusand all applicable federal, state, or foreign laws, rules, orders, or regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Change and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In To the extent applicable, in using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 1996, as amended, and the rules and regulations thereunderthereunder (collectively, “HIPAA”). To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.uu)

Regulatory Matters. The Clinical Trials. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company participated, with respect to the Company’s product and product candidates, including any such studies and trials that are described in the Prospectus Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement and the General Disclosure Package and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, to the Company’s knowledge being conducted in all material respects in accordance with experimental protocolsall applicable statutes, rules, regulations and policies of the #94192013v6 Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; to the Company’s knowledge, the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; the Company has not received received, nor does it have knowledge that any notices of its collaboration partners has received, any written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused Trials have been designed to be obtained) ensure that informed consent by or on behalf of from each human subject who participated participating in the Company Studies and TrialsTrials is obtained. In using or disclosing patient information received by the Company in connection with the a Company Studies and TrialsTrial, the Company has complied in all material respects respects, to the extent applicable, with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or on behalf of the Company and its subsidiaries that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are materially inconsistent with or call into question in question any material respect the results described or referred to in the General Disclosure Package and the Prospectus; and and, other than as disclosed in the General Disclosure Package, the Company has not received any notices notices, correspondence or correspondence other communication from the FDA FDA, EMA or any foreigncomparable U.S. or non-U.S. (federal, state or local local) governmental body exercising comparable authority or regulatory authorities of competent jurisdiction requiring the termination, suspension or or, except as would not have a Material Adverse Effect, material modification of any ongoing or planned Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company or one of its subsidiaries, as applicable, in connection with the Company Studies and Trials, the Company or one of its subsidiaries, as applicable, has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved was supervised or conducted by any investigator Investigator, as such term is defined in Title 21, Section 50.3, of the U.S. Code of Federal Regulations, who has been disqualified as a clinical investigator an Investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA FDA, EMA and comparable regulatory agencies outside of the United States bodies to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateis subject.

Regulatory Matters. The preclinical tests Clinical Trials. None of the Company’s or its subsidiaries’ product candidates have received marketing approval from any Applicable Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, with respect to the Company’s or its subsidiaries’ product candidates, including any such studies and trials that are described in the Prospectus Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are being, being conducted in all material respects in accordance with experimental protocolsall applicable Health Care Laws of the Applicable Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable Health Care Laws of the Applicable Regulatory Authorities; neither the Company nor any of its subsidiaries have received, nor does the Company have knowledge after due inquiry that any of its or its subsidiaries’ collaboration partners have received any notices written notices, correspondence or correspondence other communications from the FDA Applicable Regulatory Authorities or any foreign, state other Governmental Entity requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused Trials have been designed to be obtained) ensure that informed consent by or on behalf of from each human subject who participated participating in the Company Studies and TrialsTrials is obtained. In using or disclosing patient information received by the Company or a subsidiary in connection with the a Company Studies and TrialsTrial, the Company or such subsidiary has complied in all material respects respects, to the extent applicable, with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 HIPAA and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described or in which the Prospectus Company’s product candidates participated (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectusand all applicable federal, state, or foreign laws, rules, orders, or regulations, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In To the extent applicable, in using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 1996, as amended, and the rules and regulations thereunderthereunder (collectively, “HIPAA”). To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or on behalf of the Company and each of its subsidiaries that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries participated, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, being conducted in all material respects in accordance with experimental the protocols, procedures and controls pursuant todesigned and approved for such studies and with all applicable statutes, where applicablerules, accepted professional regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific standardsresearch procedures and any applicable rules, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has and its subsidiaries have no Knowledge knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; and the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; neither the Company nor its subsidiaries have received, nor does the Company or its subsidiaries have knowledge after due inquiry that any of its collaboration partners has not received received, any notices written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies or Trials that terminationTrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeand its subsidiaries’ knowledge, there are no reasonable grounds for the same. The Company has and its subsidiaries have obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the a Company Studies and TrialsTrial. In using or disclosing patient information received by the Company or its subsidiaries in connection with the a Company Studies and TrialsTrial, the Company has and its subsidiaries have complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect Change and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The ​ ​ Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date extent such parties are subject to the statures, rules regulation and (2) policies of the Company and its subsidiaries solely from and after FDA or comparable regulatory agency outside of the Share Exchange Closing DateUnited States.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that with respect to which termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Except as described in the General Disclosure Package and Prospectus, the Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The Clinical Trials. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company participated, with respect to the Company’s product and product candidates, including any such studies and trials that are described in the Prospectus Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, to the Company’s knowledge being conducted in all material respects in accordance with experimental protocolsall applicable statutes, rules, regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate fair summaries in all material respectsrespects of the Company Trials and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement and the Prospectus; to the Company’s knowledge, the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; the Company has not received received, nor does it have knowledge that any notices of its collaboration partners has received, any written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused Trials have been designed to be obtained) ensure that informed consent by or on behalf of from each human subject who participated participating in the Company Studies and TrialsTrials is obtained. In using or disclosing patient information received by the Company in connection with the a Company Studies and TrialsTrial, the Company has complied in all material respects respects, to the extent applicable, with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in in, or the results of which are referred to in, the Registration Statement, the Time of Sale Prospectus and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, (to the Company’s knowledge to the extent conducted by third parties) being conducted in all material respects in accordance with experimental protocolsstandard accepted medical and scientific research procedures for development programs or product candidates comparable to those being conducted or developed, procedures and controls pursuant to, where as applicable, accepted professional scientific standards, except as described in by the ProspectusCompany; the descriptions of the results of the Company Studies and Trials such tests contained in the Registration Statement, the Time of Sale Prospectus and the Prospectus are accurate and complete in all material respects; respects and fairly present the data derived from such tests, and except as described in the Time of Sale Prospectus, the Company has no Knowledge knowledge of any other studies or trials not described in the Prospectus, tests the results of which are inconsistent with or reasonably call in into question the results described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and except as described in the Time of Sale Prospectus, the Company has not received any notices or other correspondence from the FDA Food and Drug Administration of the U.S. Department of Health and Human Services or any foreigncommittee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency (collectively, state or local governmental body exercising comparable authority the “Regulatory Agencies”) requiring the termination, suspension or material modification of any Company Studies tests that are described or Trials that termination, suspension or material modification would reasonably be expected referred to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies Registration Statement, any Time of Sale Prospectus or the Prospectus; and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws operated and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated currently is in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA Regulatory Agencies. (tt) Lending Relationship. Except as disclosed in the Time of Sale Prospectus and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraphProspectus, the Company and its subsidiaries shall be deemed to refer to (1i) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date does not have any material lending or other relationship with any bank or lending affiliate of any Underwriter and (2ii) does not intend to use any of the proceeds from the sale of the Shares to repay any outstanding debt owed to any affiliate of any Underwriter. (uu) Emerging Growth Company. The Company and its subsidiaries solely from and after is an “emerging growth company,” as defined in Section 2(a) of the Share Exchange Closing DateSecurities Act (an “Emerging Growth Company”).

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and the Prospectus are accurate in all material respects; the Company has no Knowledge knowledge after reasonable investigation and due diligence inquiry (“Knowledge”) of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect material adverse effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date extent such parties are subject to the statures, rules regulation and (2) policies of the Company and its subsidiaries solely from and after FDA or comparable regulatory agency outside of the Share Exchange Closing DateUnited States.

Regulatory Matters. The Clinical Trials. All clinical and preclinical tests or studies or clinical and trials conducted by or on behalf of or sponsored by the Company, or in which the Company participated, with respect to the Company’s product and product candidates, including any such studies and trials that are described in the Prospectus Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are beingare, to the Company’s knowledge being conducted in all material respects in accordance with experimental protocolsall applicable statutes, rules, regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and controls pursuant toany applicable rules, where applicable, accepted professional scientific standards, except as described regulations and policies of the jurisdiction in the Prospectuswhich such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and complete descriptions in all material respectsrespects and fairly present the data derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement and the Prospectus; to the Company’s knowledge, the Company has operated at all times and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; the Company has not received received, nor does it have knowledge that any notices of its collaboration partners has received, any written notices, correspondence or correspondence other communications from the FDA Regulatory Authorities or any foreign, state other governmental agency requiring or local governmental body exercising comparable authority requiring threatening the termination, suspension or material modification or suspension of any Company Studies Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or Trials that terminationtrials, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused Trials have been designed to be obtained) ensure that informed consent by or on behalf of from each human subject who participated participating in the Company Studies and TrialsTrials is obtained. In using or disclosing patient information received by the Company in connection with the a Company Studies and TrialsTrial, the Company has complied in all material respects respects, to the extent applicable, with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The preclinical tests or Clinical Trials. None of the Company’s product candidates have received marketing approval from any Regulatory Authority. All clinical and pre-clinical studies or clinical and trials conducted by or on behalf of or sponsored by the Company Company, with respect to the Company’s product candidates, including any such studies and trials that are described in the Prospectus Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (the collectively, “Company Studies and Trials”) ), were, or and if still pending are, being conducted in accordance with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current Good Clinical Practices and Good Laboratory Practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are beingbeing conducted, except where the failure to be in compliance or be so conducted would not reasonably be expected to have a Material Adverse Change; the descriptions in the Registration Statement or the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in fairly present the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respectsdata derived therefrom; the Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies operated at all times and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of Regulatory Authorities; except as disclosed in the United States to which the Company is subject. For purposes of this paragraphProspectus, the Company has not received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateimplementation of such studies or trials.

Regulatory Matters. Preclinical and Clinical Testing. The studies, tests and preclinical tests or studies or and clinical trials conducted by or on behalf of of, or sponsored by, the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Prospectus (the “Company Studies and Trials”) wereSEC Documents, or the results of which are referred to in the SEC Documents, were and, if still pending pending, are being, being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standardsstandards for products or product candidates comparable to those being developed by the Company or its subsidiaries and all applicable statutes, except as described in rules and regulations of the ProspectusFDA and other comparable regulatory agencies outside of the United States to which they are subject, including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions of the results of the Company Studies such studies, tests and Trials trials contained in the Prospectus are accurate in all SEC Documents do not contain any misstatement of a material respectsfact or omit a material fact necessary to make such statements not misleading; the Company has no Knowledge knowledge of any other studies studies, tests or trials not described in the Prospectus, SEC Documents the results of which are inconsistent with or reasonably call into question in question any material respect the results of the studies, tests and trials described or referred to in the ProspectusSEC Documents; and the Company has and its subsidiaries have not received any written notices or other correspondence from the FDA or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company Studies or Trials that terminationits subsidiaries or in which the Company or its subsidiaries have participated, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated Except as disclosed in the Company Studies and Trials. In using SEC Documents, there has not been any material violation of law or disclosing patient information received regulation by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall in their respective product development efforts, submissions or reports to any regulatory authority that could reasonably be deemed expected to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Daterequire investigation, corrective action or enforcement action.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company or any of its Subsidiaries, or to the Company’s Knowledge by third parties, to support approval for commercialization of the Company’s product candidates or that are described in the Registration Statement and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional medical and scientific standards, except as described in and all applicable federal, state or foreign laws, rules, orders and regulations and all rules and regulations of the ProspectusFDA or any foreign, state or local governmental body exercising comparable authority, including current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and the Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the Registration Statement and the Prospectus; and neither the Company nor any of its Subsidiaries has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or and Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company and each of its Subsidiaries, if any, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company or any of its Subsidiaries in connection with the Company Studies and Trials, the Company has and each of its Subsidiaries, if any, have complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”) (42 U.S.C. Section 17921 et seq.), and the rules and regulations thereunder, except where noncompliance would not, singularly or in the aggregate, have a Material Adverse Effect. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA FDA, or any foreign, state or local governmental body exercising comparable authority, to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of the Company and its Subsidiaries’ suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, except where noncompliance would not, singularly or in the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateaggregate, have a Material Adverse Effect.

Regulatory Matters. There is no legal or governmental proceeding to which the Company or any subsidiary is a party or of which any property or assets of the Company or any subsidiary is the subject, including any proceeding before the United States Food and Drug Administration of the U.S. Department of Health and Human Services (“FDA”) or comparable federal, state, local or foreign governmental bodies (it being understood that the interaction between the Company and the FDA and such comparable governmental bodies relating to the clinical development and product approval process shall not be deemed proceedings for purposes of this representation), which is required to be described in the Registration Statement, the General Disclosure Package or the Prospectus or a document incorporated by reference therein and is not described therein, or which, singularly or in the aggregate, if determined adversely to the Company or any subsidiary, could reasonably be expected to have a Material Adverse Effect; and to the best of the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities or threatened by others. The Company and each subsidiary is in compliance with all applicable federal, state, local and foreign laws, regulations, orders and decrees governing its business, including its product candidates and approved products, as prescribed by the FDA, or any other federal, state or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singularly or in the aggregate, have a Material Adverse Effect. All preclinical tests or and clinical studies or clinical trials conducted by or on behalf of the Company and any subsidiary, including to support approval for commercialization of the Company’s or any subsidiary’s products, are being and have been conducted by the Company or any subsidiary, as applicable, or to the Company’s knowledge by third parties, in compliance with all applicable protocols and federal, state or foreign laws, rules, orders and regulations, except for such failure or failures to be in compliance as could not reasonably be expected to have, singularly or in the aggregate, a Material Adverse Effect. Each description of the results of studies that are described in in, or the results of which are referenced in, the Registration Statement, General Disclosure Package or the Prospectus (the “Company Studies is accurate and Trials”) were, or if still pending are being, conducted complete in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in fairly presents the Prospectus; the descriptions of the results of the data derived from such studies. The Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company has no Knowledge is not aware of any other preclinical studies or trials not described in the Prospectusclinical trials, the results of which are inconsistent with or reasonably call in into question the results described in the Registration Statement, General Disclosure Package or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or FDA, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board requiring the termination, suspension, material modification or clinical hold of any preclinical studies or clinical trials conducted by or on behalf of the Company. Neither the Company nor its subsidiaries, nor any of its or their respective officers, employees or directors, nor any of its or their clinical investigators, nor to its knowledge of its or their respective agents, has been excluded, suspended, disqualified or debarred from participation in any U.S. federal health care program or human clinical research or is subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in debarment, disqualification, suspension, or exclusion, or convicted of any crime or engaged in any conduct that would reasonably be expected to result in debarment under 21 U.S.C. § 335a or comparable foreign law. The Company and its subsidiaries have made all filings and obtained all approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”) to conduct such the studies described in the Registration Statement, General Disclosure Package or the Prospectus except as would not reasonably be expected to have, singularly or in the aggregate, a Material Adverse Effect; and the Company and its subsidiaries have not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or material modification of any Company Studies clinical trials that are described or Trials that termination, suspension or material modification would reasonably be expected referred to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and TrialsRegistration Statement, the Company has complied in all material respects with all laws and regulatory rules General Disclosure Package or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing DateProspectus.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; respects and, to the Company has Company’s knowledge, there are no Knowledge of any other studies studies, tests or trials not described in the Prospectus, the results of which are inconsistent with or reasonably call into question in question any material respect the results described or referred to in of the ProspectusCompany Studies and Trials; and the Company has not received any written notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that and which termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the sameEffect. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standardsstandards established by applicable law (e.g., except as described in the ProspectusGood Clinical Practice); the descriptions of the results of the Company Studies and Trials contained contained, or incorporated by reference, in the Registration Statement, the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence from the FDA or any foreign, state or local governmental body authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case requirements that are applicable to its conduct of the extent applicable, including, without limitation, the Health Insurance Portability Company Studies and Accountability Act of 1996 and the rules and regulations thereunderTrials. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies governmental authorities outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The Except as described in the Registration Statement and the Prospectus, the preclinical tests or and clinical studies or clinical trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company that or its subsidiaries, or in which the Company or its subsidiaries have participated, the results of which are described referred to in the Prospectus Registration Statement and the Prospectus, as applicable (collectively, the “Company Studies and TrialsStudies”) ), were, or and if still pending are beingare, being conducted in all material respects in accordance with experimental protocols, procedures all applicable rules and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions regulations of the results U.S. Food and Drug Administration and comparable regulatory agencies outside of the Company Studies and Trials contained in United States to which they are subject, including the Prospectus are accurate in all material respects; European Medicines Agency (collectively, the “Regulatory Authorities”). The Company has no Knowledge knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call in into question the results described or referred to in the Prospectus; Registration Statement and the Prospectus. The Company has not received any notices or correspondence from and its subsidiaries are, and since May 1, 2018, have operated in compliance with all applicable statutes, rules and regulations of the FDA or any foreignRegulatory Authorities and all other applicable federal, state or local governmental body exercising comparable authority requiring foreign health care laws and regulations applicable to the terminationownership, suspension testing, development, manufacture, packaging, processing, use, distribution, marketing, labeling, promotion, sale, offer for sale, storage, import, export, or material modification disposal of any product candidates under development by the Company Studies or Trials that terminationany of its subsidiaries (collectively, suspension the “Health Care Laws”), except where such non-compliance would not, singly or material modification would in the aggregate, reasonably be expected to have a Material Adverse Effect Effect. Neither the Company nor any of its subsidiaries, to the knowledge of the Company, have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination or suspension of any such Studies, and, to the knowledge of the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (Except as would not, whether singly or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by aggregate, reasonably be expected to have a Material Adverse Effect, neither the Company nor any of its subsidiaries has received any claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental or regulatory authority alleging that it is in connection with the Company Studies and Trialsviolation of any Health Care Laws, the Company has complied in all material respects with all laws and regulatory rules or requirementsand, in each case to the extent applicableknowledge of the Company, includingno such claim, without limitationaction, suit, proceeding, hearing, enforcement, investigation, arbitration or other action has been threatened. Neither the Health Insurance Portability and Accountability Act Company, its subsidiaries nor, to the knowledge of 1996 and the rules and regulations thereunder. To Company, any of the Company’s Knowledgeor its subsidiaries’ officers, none directors, employees, contractors or agents is a party to any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Regulatory Authority with respect to Health Care Laws. Neither the Company, any of its subsidiaries nor, to the knowledge of the Company Studies and Trials involved Company, any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To of the Company’s Knowledgeor its subsidiaries’ employees, the manufacturing facilities and operations of its suppliers are operated officers, directors, contractors or agents has been excluded, suspended or debarred from participation in compliance any U.S. federal health care program (as defined in all material respects with all applicable statutes42 U.S.C. § 1320a-7b(f)) or human clinical research or is subject to a governmental inquiry, rulesinvestigation, regulations and policies of the FDA and comparable regulatory agencies outside of the United States proceeding or other similar action that would reasonably be expected to which the Company is subject. For purposes of this paragraphresult in such debarment, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Datesuspension or exclusion.

Regulatory Matters. The preclinical tests or nonclinical studies or and clinical trials conducted by or to the Company’s Knowledge on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the ProspectusGeneral Disclosure Package; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call in into question the results described or referred to in the General Disclosure Package and the Prospectus; and except as set forth in the General Disclosure Package, the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect andEffect, and to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The clinical and preclinical tests or studies or clinical and trials conducted by or or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries has participated, that are described in the Prospectus (or the “Company Studies and Trials”) wereresults of which are referred to in the Prospectus, or as applicable, were and, if still pending pending, are being, being conducted in all material respects in accordance with experimental protocols, standard medical and scientific research procedures and controls pursuant toall applicable statutes, where applicablerules and regulations of the U.S. Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which it is subject (collectively, accepted professional scientific standardsthe “Regulatory Authorities”), except as described in the Prospectusincluding, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312, and current Good Clinical Practices and Good Laboratory Practices; the descriptions in the Prospectus of the results of the Company Studies such studies and Trials contained in the Prospectus trials are accurate and complete in all material respectsrespects and fairly present the data derived from such studies and trials; the Company has and its subsidiaries have no Knowledge knowledge of any other studies or trials not described in the Prospectus, the results of which are inconsistent with or otherwise call in into question the results described or referred to in the Prospectus; and the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to and its subsidiaries have a Material Adverse Effect and, to the Company’s Knowledge, there operated and are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated currently in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, Regulatory Authorities; the Company and its subsidiaries shall be deemed have not received any written notices, correspondence or other communication from the Regulatory Authorities or any applicable governmental authority requiring or threatening the termination or suspension of any clinical or preclinical studies and trials that are described in the Prospectus or the results of which are referred to refer in the Prospectus, other than ordinary course communications with respect to (1) Albireo Limited and pending clinical trials, and, to the Company’s knowledge, there are no reasonable grounds for same. Neither the Company nor its subsidiaries has received from any Regulatory Authority any regulatory, untitled or warning letter, request for recall of any products, or notice or other communication regarding the commencement or threatened commencement of any investigation, proceeding or action, such as they existed prior an action to seize any products or enjoin production of the products at any facility, or any failure or alleged failure by the Company or its subsidiaries to comply with any Applicable Laws. The Company or its subsidiaries have not introduced in commercial distribution any products which were upon their shipment by the Company or its subsidiaries adulterated or misbranded. Neither the Company nor any of its subsidiaries, nor, to the Share Exchange Closing Date and (2) knowledge of the Company, any officer, employee or agent of the Company and or any of its subsidiaries solely from and after the Share Exchange Closing Datesubsidiaries, is debarred or has been convicted or any crime or engaged in any conduct for which debarment is mandated or authorized by 21 U.S.C. §335a.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company Company, or to the Company’s Knowledge by third parties, to support approval for commercialization of the Company’s product candidates or that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional medical and scientific standards, except as described in and all applicable federal, state or foreign laws, rules, orders and regulations and all rules and regulations of the ProspectusFDA or any foreign, state or local governmental body exercising comparable authority, including current Good Clinical Practices and Good Laboratory Practices; the descriptions of the results of the Company Studies and Trials contained or incorporated by reference in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic and Clinical Health Act (the “HITECH Act”) (42 U.S.C. Section 17921 et seq.), and the rules and regulations thereunder, except where noncompliance would not, singularly or in the aggregate, have a Material Adverse Effect. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA FDA, or any foreign, state or local governmental body exercising comparable authority, to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, except where noncompliance would not, singularly or in the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Dateaggregate, have a Material Adverse Effect.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations, as well as in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in protocols that were submitted to the Prospectusrelevant regulatory authority; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement, General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence from with the FDA FDA, the DEA, the EMA, the MHRA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect and, to the Company’s Knowledgeknowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and or Trials, the Company has complied in all material respects with all federal, state, local or foreign applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunderthereunder (“HIPAA”). Neither the Company, nor its subsidiaries or any of their respective directors, officers, employees or, to the Company’s knowledge, agents is or has been debarred, suspended or excluded, or has been convicted of any crime or, to the knowledge of the Company or its subsidiaries, engaged in any conduct that would result in a debarment, suspension or exclusion from any U.S. federal or state government health care program or human clinical research. To the Company’s Knowledgeknowledge, none of the Company Studies and Trials involved any investigator investigator, as such term is defined in Title 21, Section 50.3 of the U.S. Code of Federal Regulations, who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledgeknowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, rules and regulations and policies of the FDA and FDA, the DEA, the EMA, the MHRA or comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.

Regulatory Matters. The studies, tests and preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere and, or if still pending pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge knowledge after reasonable investigation and due diligence inquiry (“Knowledge”) of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any notices or correspondence from with the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials that termination, suspension or material modification would reasonably be expected to have a Material Adverse Effect material adverse effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the Company has complied in all material respects with all applicable laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and operations of its suppliers are operated in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes of this paragraph, the Company and its subsidiaries shall be deemed to refer to (1) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing Date.