Notice of Trials. Builder shall give Owner not less than ​ advance written notice of the scheduled dates for Trials.

Locations of Trials. Builder shall secure any space necessary to carry out the Trials and operate any system of the Vessel as required herein.

Cost. Notwithstanding the foregoing, the provisions of this [Section 6.12] shall not apply to assets as to which the Administrative Agent and the Domestic Borrower shall reasonably determine that the costs and burdens of obtaining a security interest therein or perfection thereof outweigh the value of the security afforded thereby.

Cost. Notwithstanding the foregoing, the provisions of this Section 6.12 shall not apply to assets as to which the Administrative Agent and the Domestic Borrower shall reasonably determine that the costs and burdens of obtaining a security interest therein or perfection thereof outweigh the value of the security afforded thereby.

Cost. All Out-of-Pocket Costs incurred in connection with any proceeding under [Section 10.3(a)] shall be borne solely by ​.

Cost. All Alterations shall be designed and performed by Tenant at Tenant’s cost and expense; provided, however, that if any Alterations require work to be performed outside the Premises, Landlord may elect to perform such work at Tenant’s expense. Notwithstanding the foregoing, Landlord shall provide Tenant with a Tenant Improvement Allowance for Alterations performed by Tenant in connection with the initial build out of the Premises for Tenant’s occupancy (the “Initial Alterations”), including, in an amount not to exceed ten percent (10%) of the Tenant Improvement Allowance, for consultant fees incurred by Tenant in connection with the execution of this Lease. Any unused portion of the Tenant Improvement Allowance remaining as of the later of September 1, 2020 and thirteen (13) months after the Rent Commencement Date shall revert to Landlord and shall not be available for use by Tenant for any other purpose. Disbursement of the Tenant Improvement Allowance shall be in accordance with Section 10.2(g) of this Lease. Notwithstanding anything to the contrary herein, # Landlord shall be solely responsible for all costs due to the presence of Hazardous Materials on or about the Project, and # the Rent Commencement Date shall be extended by one (1) day for each day Tenant’s completion of the Initial Alterations is delayed due to Landlord’s delay. Landlord shall endeavor to respond to any consent or approval request by Tenant within five (5) business days.

Set forth on [Schedule 3.11(i)] is a complete and accurate list of all clinical trials involving a Compound that have been initiated since the ​, whether or not such trials are still ongoing, which list shall include all investigator-initiated and Seller-sponsored clinical trials.

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. 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.