Clinical Trials. The JDC will allocate responsibility between the Parties for the conduct of Clinical Trials and the various other Development activities addressed in the Global Development Plan. The JDC will have final decision-making authority with respect to the protocol for any Clinical Trial conducted under the Global Development Plan and the statistical analysis plan for any such Clinical Trial. The Party that has responsibility for conducting the Clinical Trial will have the responsibility for the packaging and labeling of clinical drug supplies, unless otherwise agreed by the Parties.

In the event a Party (the “Additional Development Party”) proposes to perform a Clinical Study (other than a PRAS) (any such Clinical Study, an “Additional Clinical Study”) of the Product in the Field as a sponsor, it shall provide the other Party (“non-Additional Development Party”) an opportunity to review a proposed study protocol and related budget to such protocol (together, the “Protocol”) as well as the publication plan in accordance with Article 9.5, if available, through the JSC, provided, however, that with respect to Licensor, this Article 4.3 shall only apply to those Clinical Studies that are being conducted or proposed to be conducted in the Non-Encumbered Territory, unless Licensor, in its sole discretion, offers to Licensee the opportunity to participate in such Clinical Studies.

Clinical Trials. The preclinical tests and clinical trials that are described in, or the results of which are referred to in, the SEC Reports were and, if still pending, are being conducted in all material respects in accordance with protocols filed with the appropriate Regulatory Agencies for each such test or trial, as the case may be, and with standard medical and scientific research procedures and all applicable statutes, directives, rules and regulations of the Regulatory Agencies, including, without limitation, the Federal Food, Drug and Cosmetic Act and the rules and regulations promulgated thereunder; each description of such tests and trials, and the results thereof, contained in the SEC Reports is accurate and complete in all material respects and fairly presents the data about and derived from such tests and trials, and the Borrower has no knowledge of any other studies or tests, the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the SEC Reports; neither the Borrower nor its Subsidiaries has received any notices or other correspondence from any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the SEC Reports; and each of the Borrower and its Subsidiaries has operated and currently is in compliance in all material respects with all applicable rules and regulations of the Regulatory Agencies.

Clinical Trials. The clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or, to the Company’s knowledge, in which the Company has participated, that are described in the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus, as applicable, and are intended to be submitted to Regulatory Authorities (as defined herein) as a basis for product approval, were and, if still pending, are being conducted in all material respects in accordance with standard medical and scientific research procedures and all applicable statutes, rules and regulations of the United States Food and Drug Administration and comparable drug regulatory agencies outside of the United States to which it is subject (collectively, the “Regulatory Authorities”), including, without limitation, 21 C.F.R. Parts 50, 54, 56, 58, and 312; the descriptions in the Registration Statement, or the Prospectus of the results of such studies and trials are accurate and complete in all material respects and fairly present the data derived from such trials; the Company has no knowledge of any other trials the results of which are inconsistent in any material respect with or otherwise call into question the results described or referred to in the Registration Statement, and the Prospectus; the Company and its subsidiaries have each operated and are currently in compliance with all applicable statutes, rules and regulations of the Regulatory Authorities; neither the Company, nor any of its subsidiaries, has received any written notices, correspondence or other written communication from the Regulatory Authorities or any governmental authority which could lead to the termination or suspension of any clinical or pre-clinical trials that are described in the Prospectus or the results of which are referred to in the Prospectus, and there are no reasonable grounds for same.

Clinical Trials. In the event of termination of the Agreement for any reason, if applicable, INNOCOLL shall be permitted to continue in its sole discretion any ongoing clinical trial for a Licensed Product for which INNOCOLL has responsibility and in which patient dosing has commenced. In the event the agreement is terminated by INNOCOLL pursuant to Section 10.2(a) or 10.2(b), or (a) by [[DURECT:Organization]] pursuant to Section 10.2(c) or (b), if INNOCOLL elects not to continue such trial, [[DURECT:Organization]], at its sole election, shall have the right but not the obligation to take over the cost and responsibility for such trial, in which case INNOCOLL shall use ​ to effect a smooth transition of such trial to [[DURECT:Organization]] or its designee.

53 Article 13 REPRESENTATIONS AND WARRANTIES; COVENANTS

Other Clinical Trials. Except for the Combined Therapy Trials, each clinical trial for the Nektar Compound and the CPI Compound and the BioXcel Compound, alone or in combination with other pharmaceutical agents, is independently conducted and shall not be subject to this Agreement (but without limiting each Party’s obligation to share relevant safety information as provided in Section 2.1(c), Section 2.1(d) and Section 2.2). The Nektar Compound provided to BioXcel under this Agreement shall not be used for such other clinical trials. Nothing in this

Other Clinical Trials. Nothing in this Agreement shall preclude either Party from conducting any other clinical trials as it may determine in its discretion, so long as it does not use or rely on the Confidential Information that is solely owned by the other Party in doing so.

Clinical Trials. The descriptions in the Registration Statement and the Prospectus of the design, status and results of clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company have participated, are accurate and complete in all material respects and fairly present the data derived from such trials and the Company has no knowledge of subsequent results from such trials or results from any other trials that are inconsistent with or otherwise call into question the results described or referred to in the Registration Statement and the Prospectus, taken as a whole. The Company has operated and is currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the FDA and comparable drug regulatory agencies outside of the United States to which it is subject (collectively, the “Regulatory Authorities”) and all clinical trials have been conducted in accordance with good clinical practices, applicable institutional review board (“IRB”) or independent ethics committee (“IEC”) requirements, and standard medical and scientific research procedures. The Company has not received any notices, correspondence or other communication from the Regulatory Authorities or any other governmental agency or IRB or IEC which could reasonably lead to the early termination or suspension of any ongoing clinical trials or pre-clinical studies that are described in the Registration Statement and the Prospectus or the results of which are referred to in the Registration Statement and the Prospectus or rejection of data from these trials or studies and, to the Company’s knowledge, there are no reasonable grounds for the same, including on the basis of # pending or submitted safety reports concerning products manufactured or distributed by or for the Company or # results of clinical and pre-clinical trials conducted by or on behalf of or sponsored by the Company, or in which the Company has participated.

Clinical Trials Insurance. Effective at least ​ prior to the launch of any Clinical Trial, each Party shall maintain in force Clinical Trial insurance, with a minimum limit of ​ in the aggregate to be maintained in force throughout the life of any such Clinical Trials, such insurance to be effected, maintained and documented to the other Party in compliance with this Agreement and in compliance with any and all local requirements in any territory in which such trials are conducted.