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 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 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. 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. 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 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 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 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 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 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 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, the Pricing Disclosure Package and the Prospectus (the “Company Studies and Trials”) werewere 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, the Pricing Disclosure Package 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 Registration Statement, any Preliminary Prospectus; , the Pricing Disclosure Package 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 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 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 clinical, pre-clinical and other 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 the Prospectus; FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by 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 clinical or pre-clinical 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 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 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 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 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 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 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 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 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 X4 and its subsidiaries as they existed prior to the Share Exchange Merger Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Merger 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 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 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 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 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 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 the Prospectus, the Company (i) does not have any material lending or other relationship with any bank or lending affiliate of any Underwriter and (ii) does not intend to use any of the United States proceeds from the sale of the Shares to repay any outstanding debt owed to any affiliate of any Underwriter. (uu) Emerging Growth Company. From the time of initial confidential submission of the Registration Statement to the Commission (or, if earlier, the first date on which the Company is subject. For purposes of this paragraphengaged directly or through any Person authorized to act on its behalf in any Testing-the-Waters Communication) through the date hereof, the Company has been and its subsidiaries shall be deemed to refer to is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (1an “Emerging Growth Company”). “Testing-the-Waters Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) Albireo Limited and its subsidiaries as they existed prior to of the Share Exchange Closing Date and (2) the Company and its subsidiaries solely from and after the Share Exchange Closing DateSecurities Act.

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 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 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 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 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 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. The (a) Each product researched or developed by the Company or any of its Subsidiaries has been and is being researched and developed by the Company in compliance with all applicable Laws, including applicable Laws promulgated by Health Canada or the FDA. As of the date hereof, neither the Company nor any of its Subsidiaries, nor any of its or its Subsidiaries’ licensees, has received any notices or correspondence from Health Canada, the FDA or any other Governmental Authority exercising comparable authority (i) contesting the investigational or premarket clearance or approval of, the testing of, or the uses of, any products of the Company or any of its Subsidiaries or (ii) otherwise alleging any material violation applicable to any such products by the Company or any of its Subsidiaries of any Law. (b) To the knowledge of the Company, there are no facts, circumstances or conditions that would reasonably be expected to form the basis for any audit, investigation, suit, claim, action or proceeding with respect to a recall, withdrawal, suspension, seizure or discontinuance, or change in the marketing classification or labeling, of any products of the Company. True and complete copies of all material data of the Company with respect to the safety or efficacy of the products of the Company are contained in the Data Room Information. (c) Except as set out in the Company Disclosure Letter, the studies, tests and preclinical tests or studies or and clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies and Trials”) wereits Subsidiaries were and, or if still pending pending, are being, being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, to generally accepted professional scientific standards, except as described in the Prospectus; the descriptions institutional review board requirements and applicable Laws and Permits. The description of the results of such studies, tests and trials submitted to Health Canada, the Company Studies FDA and Trials contained in the Prospectus other Governmental Authorities are accurate true and complete in all material respects; respects and fairly present the data derived from such studies, tests and trials, and neither the Company has no Knowledge nor any of its Subsidiaries is aware of any other studies studies, tests or trials not described in the Prospectus, the results of which are inconsistent with or the Company reasonably believes call in into question the results described of any studies, tests or referred to in trials conducted by or on behalf of the Prospectus; and the Company or any of its Subsidiaries. The Company has not received any notices or correspondence from Health Canada, the FDA or any foreign, state or local governmental body other Governmental Authority exercising comparable authority requiring the termination, suspension or material modification of any Company Studies studies, tests or Trials that termination, suspension preclinical 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 clinical trials conducted by or on behalf of each human subject who participated in the Company Studies or any of its Subsidiaries. The materials and Trials. In using or disclosing patient information received regarding studies, tests and preclinical and clinical trials provided by the Company in connection with to the Offeror do not fail to state a material fact regarding such studies, tests and preclinical and clinical trials. (d) All reports, documents, claims, notices or approvals required to be filed, obtained, maintained or furnished to any Governmental Authority for each material product of the Company Studies or any of its Subsidiaries have been so filed, obtained, maintained or furnished, and Trialsall such reports, the Company has complied documents, claims, notices and approvals were true and complete in all material respects with all laws and regulatory rules on the date filed (or requirementswere corrected in, in or supplemented by, a subsequent filing). As to 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 product of the Company Studies and Trials involved or any investigator who of its Subsidiaries for which any domestic or foreign regulatory application (including without limitation an investigational new drug application) has been disqualified as a clinical investigator submitted, approved 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 paragraphcleared, the Company and its subsidiaries shall be deemed to refer to Subsidiaries are in compliance with all legal requirements and applicable Laws and all terms and conditions of such applications. (1e) Albireo Limited and its subsidiaries as they existed prior to the Share Exchange Closing Date and (2) Neither the Company and nor any of its subsidiaries solely from and after Subsidiaries has received any written notice that Health Canada, the Share Exchange Closing DateFDA or any other Governmental Authority has commenced, or threatened to initiate, any action to withdraw its approval, request the recall or enjoin the production of any product of the Company.

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 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.

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 preclinical tests or studies or clinical trials conducted by or on behalf of the Company that are described in the Prospectus (the “Company Studies a) Seller has operated 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 currently is in compliance in all material respects with all applicable statutes, rules, statutes and implementing regulations and policies of the FDA and comparable regulatory agencies outside of administered or enforced by the United States Food and Drug Administration (“FDA”) or any similar Governmental Entity outside the United States (each, including the FDA, a “Regulatory Authority”). (b) The Company holds, and is operating in compliance in all material respects with, such licenses, permits, authorizations, certificates, franchises, consents and other approvals from any governmental body relating to the Business which are required in order for Seller to operate the Company is subject. For purposes of this paragraphBusiness as presently conducted (collectively, the Company “Regulatory Permits”), and is in compliance in all material respects with all such Regulatory Permits. The Seller has fulfilled and performed all of its subsidiaries shall be deemed material obligations with respect to refer the Regulatory Permits, and no event has occurred which allows, or after notice or lapse of time would allow, suspension, revocation or termination thereof or result in any other material impairment of the rights of the holder of any Regulatory Permit. All applications, notifications, product reports and submissions submitted in connection with any and all requests for a Regulatory Permit from any Regulatory Authority, were truthful and accurate in all material respects as of the date of submission and as of the date of the marketing authorization, and with respect to any marketing applications complete in all material respects as of the date of submission. To the knowledge of Seller, any necessary or required changes, modifications, updates, or corrections to such applications, notifications, and submissions have been submitted to any Regulatory Authority. (1c) Albireo Limited All of Seller’s products that are subject to the jurisdiction of a Regulatory Authority are being, and have been, designed, manufactured, imported, exported, processed, developed, labeled, stored, tested, marketed, promoted and distributed by or, on behalf of Seller in compliance in all material respects with all applicable requirements under any Regulatory Permit or law, including applicable statutes and implementing regulations administered or enforced by the Regulatory Authority. (d) All preclinical studies and clinical trials conducted by or, to the knowledge of Seller, on behalf of Seller have been, and if still pending are being, conducted in compliance in all material respects with the research protocols applicable to each such study or test and all applicable law, including the United States Federal Food, Drug, and Cosmetic Act, its subsidiaries as they existed applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 812 and applicable good clinical practices or good laboratory practices, and 21 C.F.R. Parts 1000 through 1050. No clinical trial conducted by or, to the knowledge of Seller, on behalf of Seller has been terminated or suspended prior to completion, and no Regulatory Authority, or institutional review board or ethics committee, that has or has had jurisdiction over a clinical trial conducted by or on behalf of Seller has commenced, or to the Share Exchange Closing Date knowledge of Seller, threatened to commence, any Proceeding investigation, audit, demand, or assessment to place a clinical hold order on, or otherwise terminate or suspend, any proposed or ongoing clinical investigation conducted or proposed to be conducted by or on behalf of Seller. No clinical trial conducted by or, to the knowledge of Seller, on behalf of Seller, has utilized the services of a clinical investigator or any other Person that was then or later became debarred or disqualified by a Regulatory Authority (including debarment under the Generic Drug Enforcement Act of 1992, 21 U.S. C. §§335a-335c). (e) Seller has not had any product or manufacturing site subject to a Governmental Entity shutdown or import or export prohibition, nor received any written notice of inspectional observations from a Regulatory Authority, “warning letters,” “untitled letters” or requests or requirements to make changes to the products or any of Seller’s manufacturing processes or procedures, or similar written correspondence or notice from a Regulatory Authority in respect of the Business or Seller, as applicable, and alleging or asserting noncompliance with any applicable law, Regulatory Permit or such requests or requirements of a Regulatory Authority. To the knowledge of Seller, no contract manufacturer of Seller has had any manufacturing site subject to a Governmental Entity (2including FDA or other Regulatory Authority) shutdown, or received any correspondence or notice from the Company any Regulatory Authority or any other Governmental Entity, alleging or asserting noncompliance with any applicable law, Regulatory Permit or requirements of a Governmental Entity for problems that could affect products manufactured by or on behalf of Seller. (f) There are not and its subsidiaries solely from have not been any (i) recalls, field notifications, corrections, product replacements, warnings, “dear doctor” letters, investigator notices, safety alerts, reports of accidental radiation occurrences, notifications of defect or failure to comply under 21 C.F.R. Part 1003 or other notice of any Proceeding investigation, audit, demand, or assessment relating to an alleged lack of safety or regulatory compliance of the products issued by Seller (“Safety Notices”) or (ii) material product complaints with respect to the medical device products. To the knowledge of Seller, there are no facts that would be reasonably likely to result in (A) a material Safety Notice with respect to the medical device products, (B) a material change in the labeling of any of the medical device products due to a safety or performance issue, or (C) a termination or suspension of developing and after testing of any of the Share Exchange Closing Datemedical device products due to safety or performance issues. All adverse events occurring within or outside the United States have been submitted to the applicable Regulatory Authority in accordance with applicable law.

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. (a) The preclinical tests or studies or manufacturing, processing, distribution, labeling and storage of clinical trials conducted trial supplies performed by or or, to the Company’s Knowledge, on behalf of the Company that are described in material compliance with all laws, rules, regulations or orders administered or issued by the Prospectus (FDA and any other Governmental Entity responsible for regulating the “Company Studies and Trials”) were, or if still pending are being, conducted pharmaceutical industry as applicable to products in all material respects pre-commercial clinical development in accordance with industry standard practices. (b) To the Company’s Knowledge, all pre-clinical and clinical investigations conducted or sponsored by the Company are being conducted in material compliance with all applicable experimental protocols, procedures laws, rules and controls pursuant toregulations, where applicableincluding the applicable Good Laboratory Practice and Good Clinical Practice requirements relating to informed consent and institutional review boards designed to ensure the protection of the rights and welfare of human subjects as set forth in 21 C.F.R. Parts 50, accepted professional scientific standards54, except 56, 58 and 312, as well as federal and state laws, rules and regulations restricting the use and disclosure of individually identifiable health information. (c) The Company has made available to Parent all material information known to it with respect to the safety or efficacy of the Product Candidates. To the Company’s Knowledge, the Company is not in possession of information that would reasonably be expected to lead to the denial by FDA of an application for regulatory approval necessary for the sale (“Regulatory Approval“) in the United States of Treanda for use as a single agent for the NHL indication specified in the SPA Resubmission, provided that the development of Treanda for such indication proceeds in adherence to the Treanda Development Plan dated March 15, 2005, as updated in the SPA Resubmisson dated April 29, 2005 and by the Update to IND # 67,554 dated April 11, 2005. To the Company’s Knowledge, the Company is not in possession of information that would reasonably be expected to lead to the denial by FDA of Regulatory Approval in the United States of Treanda for CLL. To the Company’s Knowledge, if the development of SDX-101 for the indication of CLL in the United States proceeds in adherence with the SDX-101 development plan dated March 17, 2005, the Company is not in possession of information that would reasonably be expected to lead to the denial by FDA of Regulatory Approval in the United States of SDX-101 for CLL. The Company’s Treanda Development Plan dated March 15, 2005, the Company’s SDX-101 Development Plan dated March 17, 2005, the SPA Re-submission (with respect to a single agent) dated April 29, 2005 and the Update to IND # 67,554 dated April 11, 2005 have been delivered to Parent. (d) The Company (i) has not received any FDA Form 483, notice of adverse finding, warning letters or other written correspondence or notice from FDA or any other Governmental Entity responsible for regulating the pharmaceutical industry alleging or asserting noncompliance with any applicable laws; (ii) has no Knowledge or reason to believe that the FDA or other such Governmental Entity is considering such action described in the Prospectussubsection (i) above; the descriptions of the results of the Company Studies and Trials contained in the Prospectus are accurate in all material respects; the Company (iii) has no Knowledge of any actual or threatened prosecution, injunction, seizure, civil fine, suspension, recall or other studies enforcement action or trials proceeding by FDA or other Governmental Entity responsible for regulating the pharmaceutical industry alleging that the Company is not currently in compliance with any and all applicable laws, regulations or orders; and (iv) has no Knowledge that any such Governmental Entity is considering such action described in the Prospectussubsection (iii) above; in each of (i) through (iv) above, the results of which are inconsistent with except for such actions as would not, individually 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 foreignaggregate, 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 thereunderEffect. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical investigator Workers is or has been found the subject of any of the foregoing pending or threatened actions or proceedings. (e) To the Company’s Knowledge, no data generated by it or on its behalf is the subject of any regulatory or other action, either pending or threatened, by the FDA or other Governmental Entity responsible for regulating the pharmaceutical industry relating to the truthfulness of such data. (f) To the Company’s Knowledge, it is not the subject, officially or otherwise, of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue, Material Facts, Bribery, and Illegal Gratuities Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or by the Department of Health and Human Services Office of Inspector General (“OIG“) or United States Department of Justice (“DOJ“) pursuant to the Federal Anti-Kickback Statute 42 U.S.C. Section 1320a-7(b) and the Civil False Claims Act (31 U.S.C. Section 3729 et seq.) and the regulations promulgated pursuant to such statutes. (g) To the Company’s Knowledge, neither it nor any of the Company Workers has knowingly committed any act, made any statement, or failed to make any statement, that would reasonably be expected to provide a basis for the FDA to invoke its Fraud, Untrue, Material Facts, Bribery, and Illegal Gratuities Final Policy or that would reasonably be expected to provide a basis for liability under the Federal Anti-Kickback Statute or the Civil False Claims Act and any regulations promulgated thereunder. (h) Neither the Company nor to the Company’s Knowledge, any of the Company Workers, or any licensees, licensors or assignees of the Company Intellectual Property has received any notice that the FDA or any other Governmental Entity responsible for regulating the pharmaceutical industry has initiated, or threatened in writing, or to the Company’s Knowledge, orally to initiate, suspend or terminate any Investigational New Drug Application sponsored by the Company, or to recall, suspend or otherwise restrict the manufacture of any pharmaceutical product of the Company. (i) To the Company’s Knowledge, all animal studies or other preclinical tests performed in connection with or as the basis for any regulatory approval required for the Product Candidates either (x) have been conducted in accordance, in all material respects, with applicable Good Laboratory Practice requirements contained in 21 CFR Part 58, (y) were pilot safety studies or (z) involved experimental research techniques that are not generally performed by registered GLP testing laboratories and have employed the procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to those being developed by the Company. (j) To the Company’s Knowledge, there are no proceedings pending with respect to a violation by the Company of the FDCA, FDA regulations adopted thereunder or any other legislation or regulation promulgated by any other Governmental Entity responsible for regulating the pharmaceutical industry, except for such proceedings as would not, individually or in the aggregate, reasonably be expected to have engaged a Material Adverse Effect. (k) No employee of the Company is in scientific misconductviolation of any term of any patent disclosure agreement, or to the Company’s Knowledge, any non-competition agreement or any restrictive covenant (i) in favor of the Company, or (ii) to a former employer relating to the right of any such employee to be employed because of the nature of the business conducted by the Company or to the use of trade secrets or proprietary information of others. 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 as of the FDA and comparable regulatory agencies outside of the United States to which the Company is subject. For purposes date of this paragraphAgreement, no key employee or group of employees has any plans to terminate employment with 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 DateCompany.

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 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 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 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 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. 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 preclinical tests or studies or Clinical Trials. None of the Company’s Product Candidates have received marketing approval from any Regulatory Authority. All clinical trials and preclinical studies conducted by or on behalf of the Company that are described in the Registration Statement, the Time of Sale Prospectus and the Prospectus, (the collectively, “Company Studies and Trials”) were), or were and, if still pending are being, conducted in all material respects in accordance with experimental protocolsall Applicable Laws, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in where the Prospectusfailure to so conduct would not be reasonably expected to have a Material Adverse Effect; the descriptions in the Registration Statement, the Time of Sale Prospectus and the Prospectus of the results of the any Company Studies and Trials contained in the Prospectus are accurate and non-misleading descriptions in all material respects; 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 reasonably contradict in question any material respect the results of the Company Trials described or referred to in the Registration Statement, the Time of Sale Prospectus and the Prospectus; and the Company has not received any notices written notices, correspondence, or correspondence other communication from the FDA or any foreign, state or local governmental body exercising comparable authority other Governmental Agency requiring the termination, suspension or material modification or suspension of any Company Studies or Trials that Trials, which termination, suspension or material modification or suspension 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 thereunderEffect. 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 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 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 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 studies or clinical trials conducted by or on behalf of the Company that are described in the Time of Sale Prospectus 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 Time of Sale Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Time of Sale Prospectus and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Time of Sale Prospectus and the Prospectus, the results of which are inconsistent with or call in question the results described or referred to in 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 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 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 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 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. 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, 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. None of the Company’s Product Candidates have received marketing approval from any Regulatory Authority. All clinical trials and preclinical studies conducted by or on behalf of the Company that are described in the Prospectus Registration Statement, the General Disclosure Package and the Final Prospectus, (the collectively, “Company Studies and Trials”) were), or were and, if still pending are being, conducted in all material respects in accordance with experimental protocolsall Applicable Laws, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in where the Prospectusfailure to so conduct would not be reasonably 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 the any Company Studies and Trials contained in the Prospectus are accurate and non-misleading descriptions in all material respects; 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 reasonably contradict in question any material respect the results of the Company 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 written notices, correspondence, or correspondence other communication from the FDA or any foreign, state or local governmental body exercising comparable authority other Governmental Agency requiring the termination, suspension or material modification or suspension of any Company Studies or Trials that Trials, which termination, suspension or material modification or suspension 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 thereunderEffect. 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 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 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 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.