Common use of Preclinical Studies and Tests and Clinical Trials Clause in Contracts

Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company; the descriptions of the results of such tests, studies and trials contained in the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the General Disclosure Package and the Prospectus the results of which reasonably call into question the results of the tests, studies and trials described in the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company has not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.

Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company and its subsidiaries that are described in the General Disclosure Package or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the CompanyCompany and its subsidiaries; the descriptions of the results of such tests, studies and trials contained in the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the General Disclosure Package and the Prospectus the results of which reasonably call into question the results of the tests, studies and trials described in the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company has and its subsidiaries have not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company and its subsidiaries which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.

Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical studies and clinical trials conducted by or on behalf of the Company and its subsidiaries that are described in the General Disclosure Package or Time of Sale Document and the Prospectus Final Offering Memorandum were and, if still pending, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the CompanyCompany and its subsidiaries; the descriptions of the results of such tests, studies and trials contained in the General Disclosure Package or Time of Sale Document and the Prospectus Final Offering Memorandum do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the General Disclosure Package Time of Sale Document and the Prospectus Final Offering Memorandum the results of which reasonably call into question the results of the tests, studies and trials described in the General Disclosure Package Time of Sale Document and the ProspectusFinal Offering Memorandum; and, except as disclosed in the General Disclosure Package Time of Sale Document and the ProspectusFinal Offering Memorandum, the Company has and its subsidiaries have not received any notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, conducted by or on behalf of the Company and its subsidiaries which termination, suspension, clinical hold or material modification would reasonably be expected to have a Material Adverse Effect.

Preclinical Studies and Tests and Clinical Trials. The testsCompany and its Subsidiaries have operated and currently are in compliance in all material respects with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA, the DEA and other federal, state, local and foreign governmental bodies exercising comparable authority. The nonclinical studies and clinical trials conducted by or on behalf of the Company and its Subsidiaries that are described in the Registration Statement, the General Disclosure Package or and the Prospectus were were, and, if still 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 standards for products or product candidates comparable to those being developed by the CompanyCompany and its Subsidiaries; the descriptions of such nonclinical studies and clinical trials, and the results thereof, conducted by or on behalf of such tests, studies the Company and trials contained in the General Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not its Subsidiaries described in the General Disclosure Package and the Prospectus are accurate and complete in all material respects; the Company and its Subsidiaries have submitted to the FDA an Investigational New Drug Application (“IND”) for each new drug for which it is sponsoring or conducting clinical trials and has updated such INDs as required by the FDA; the Company is not aware of any tests, studies or trials not described or referred to in the General Disclosure Package and the Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described or referred to in the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company has and its Subsidiaries have not received any notices written or correspondence oral notice from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority authority, requiring the termination, suspension, clinical hold or material modification of any testsnonclinical study or clinical trial, studies or trials, conducted by or on behalf of the Company which termination, suspension, suspension or clinical hold or material modification would reasonably be expected to have a Material Adverse Effect. The Company is and at all times has been in material compliance with all statutes, rules and regulations applicable to the ownership, testing, development, manufacturing, packaging, processing, use, distribution, marketing, labeling, promotion, storage, import, export and disposal (“Applicable Laws”) of any product or product candidate being developed by, manufactured by or for or distributed by the Company; has not received an FDA Form 483, warning letter or other notice from the FDA or any other federal, state, local or foreign governmental authority alleging material noncompliance with any Applicable Laws; and has submitted all material reports, records, and other information required by any Applicable Law and all such reports, records and other information were materially complete and accurate on the date filed.

Preclinical Studies and Tests and Clinical Trials. The testsCompany and its subsidiaries have operated and currently are in compliance with any applicable provisions of the United States Federal Food, nonclinical Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and any similar Australian Governmental Entities, and other federal, state, local and foreign Governmental Entities exercising comparable authority, except where the failure to so operate or be in compliance would not, singly or in the aggregate, have a Material Adverse Effect. The preclinical studies and tests and clinical trials conducted by or on behalf of the Company and its subsidiaries (including, without limitation, any investigator sponsored studies, tests or trials) that are described in the Registration Statement, the General Disclosure Package or the Prospectus were were, and, if still 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 standards for products or product candidates comparable to those being developed by the CompanyCompany and its subsidiaries; the descriptions of such studies, tests and trials, and the results thereof, conducted by or on behalf of such tests, studies and trials the Company or any of its subsidiaries contained in the Registration Statement, the General Disclosure Package or the Prospectus do are accurate and complete in all material respects; the Company is not contain aware of any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described in the Registration Statement, the General Disclosure Package and the Prospectus Prospectus, the results of which reasonably call into question the results of the tests, studies and trials described in the Registration Statement, the General Disclosure Package and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectusnone of Alchemia, the Company or any of its subsidiaries has not received any notices written notice or correspondence from the FDA FDA, any similar Australian Governmental Entity or any other foreign, state or local governmental body Governmental Entity exercising comparable authority or any Institutional Review Board or comparable foreign, state or local authority requiring the termination, suspension, clinical hold or material modification of any tests, studies or trials, trials conducted or being conducted by or on behalf of the Company or any of its subsidiaries (including, without limitation, any investigator sponsored studies, tests or trials), which terminationterminations, suspension, clinical hold or material modification would reasonably be expected to have have, individually or in the aggregate, a Material Adverse Effect.

Preclinical Studies and Tests and Clinical Trials. The tests, nonclinical preclinical studies and tests and clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package or the Prospectus were SEC Reports were, and, if still pending, are being being, conducted by the Company, or, to the Knowledge of the Company, on behalf of the Company in all material respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company, including but not limited to human subject protections and Institutional Review Board requirements; and such preclinical studies and tests and clinical trials were and, if still pending, are being conducted by the Company, or, to the Knowledge of the Company, on behalf of the Company in all materials respects in accordance with applicable laws and regulations of the FDA or any other applicable federal, state, local or foreign governmental or regulatory authority; the descriptions of such studies, tests and trials, and the results thereof, conducted by or on behalf of such tests, studies and trials the Company contained in the General Disclosure Package or SEC Reports are accurate and complete in all material respects; the Prospectus do Company is not contain aware of any misstatement of a material fact or omit to state a material fact necessary to make such statements not misleading. To the Company’s knowledge, there have been no tests, studies or trials conducted with respect to the Company’s product candidates not described or referred to in the General Disclosure Package and the Prospectus SEC Reports, the results of which reasonably call into question the results of the tests, studies and trials described or referred to in the General Disclosure Package SEC Reports; and the Prospectus; and, except as disclosed in the General Disclosure Package and the Prospectus, the Company has not received any notices notice or correspondence from the FDA or any foreignother applicable federal, state state, local or local foreign governmental body or regulatory authority exercising comparable authority authority, or any Institutional Review Board or comparable authority requiring the termination, suspension, clinical hold hold, material delay or material modification of any tests, studies or trials, conducted by or on behalf of the Company which termination, suspension, clinical hold hold, material delay or material modification would reasonably be expected to have a Material Adverse Effect.