Preclinical Studies. (i) Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the preclinical studies conducted by or, to the knowledge of the Company, on behalf of or sponsored by the Company or its subsidiaries, or in which the Company or its subsidiaries have participated, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, were, and if still pending, are, being conducted in all material respects in accordance with standard medical and scientific research standards and procedures for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the U.S. Food and Drug Administration and comparable regulatory agencies outside of the United States to which they are subject, including the European Medicines Agency (collectively, the “Regulatory Authorities”) and all applicable statutes, rules and regulations of the Regulatory Authorities and Good Clinical Practice and Good Laboratory Practice requirements; (ii) the descriptions in the Registration Statement, the Pricing Disclosure Package and the Prospectus of the results of such studies are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; (iii) the Company has no knowledge of any other studies not described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus; (iv) the Company and its subsidiaries have operated at all times and are currently in compliance in all respects with all applicable statutes, rules and regulations of the Regulatory Authorities, except that where such non-compliance would not, individually or in the aggregate, have a Material Adverse Effect; (v) the Company has provided the Underwriters with all substantive written notices, correspondence and summaries of all other communications from the Regulatory Authorities; and (vi) neither the Company nor any of its subsidiaries have received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the te...
Preclinical Studies. The preclinical studies conducted by or on behalf of the Company that are described in the Registration Statement and the Prospectus (the “Company Studies”) were and, if still pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations; the descriptions of the results of the Company Studies contained in the Registration Statement and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or tests 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 foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies; except for such terminations, suspensions or material modifications which would not reasonably be expected to have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same.
Preclinical Studies. Except as disclosed in Section 23 of the Corporation Disclosure Letter, all animal studies or other preclinical tests performed in support of any application planned for Health Care Approval required for the Products have either: (a) been conducted in accordance, in all material respects, with applicable GLP requirements or (b) involved experimental research techniques that could not be performed by a registered GLP testing laboratory (with appropriate notice being given to the FDA or comparable foreign Governmental Entities) and have employed in all respects the procedures and controls generally used by qualified experts in animal or the preclinical study of comparable products.
Preclinical Studies. The preclinical studies conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (the “Company Studies”) were and, if still pending, are being, conducted in all material respects with all applicable federal, state and foreign laws, rules, orders and regulations; the descriptions of the results of the Company Studies contained in the Registration Statement, General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge of any other studies or tests not described in the Registration Statement, 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 Registration Statement, General Disclosure Package and the Prospectus; and the Company has not received any written notices or correspondence 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; except for such terminations, suspensions or material modifications which would not reasonably be expected to have a Material Adverse Effect and, to the Company’s knowledge, there are no reasonable grounds for the same.
Preclinical Studies. Without limiting the generality of Section 2.12(a), all preclinical studies conducted by or on behalf of any Acquired Company have been and are being conducted in compliance with all applicable requirements of the Animal Welfare Act and (i) Good Laboratory Practices (“GLP”) as set forth in 21 C.F.R. Part 58 or (ii) involved experimental research techniques that could not be or were not performed by a registered GLP testing laboratory (with legally required notice being given to the FDA or applicable Governmental Body) and have employed the procedures and controls generally used by qualified experts in animal or preclinical study of products comparable to those being developed in connection with the study of the Company Products. No Acquired Company has received any notice that the FDA or any other Governmental Body has recommended, initiated, or threatened to initiate any action to suspend, terminate, or otherwise restrict any preclinical studies conducted by or on behalf of any Acquired Company.
Preclinical Studies. Characterizations of ESS in vitro have included anatomic and physiologic comparisons with natural human skin, incorporation of melanocytes to generate pigmentation (Figure 2), addition of microvascular endothelial cells to promote organization of a vascular plexus 28, and grafting to athymic mice to assess changes in these properties, and stability of healed skin over extended periods of time 13,29. Genetically-modified ESS have also been reported by Xxxxxxx Supp, Ph.D., for expression of PDGF, VEGF, beta-defensins, both in vitro and in after grafting to athymic mice 30,31. This model has also been used to study electro-spun biopolymer scaffolds and stem cell populations. The model is also readily adaptable for studies of regeneration of nerve and epidermal adnexi (glands and hair).
Preclinical Studies. In vitro studies: In vitro studies will be performed to investigate the immunogenicity of Tarmogens expressing NCI’s proprietary TAAs and GI 4000 Tarmogen expressing point mutated ras. [*] • [*] • [*] several additional mutually agreeable tumor antigens supplied by NCI will be engineered by GlobeImmune, Inc. into Tarmogens for preclinical evaluation at NCI and at GlobeImmune, Inc. These genes include Brachyury, [*]. • XX-0000 Xxxxxxxxx expressing point mutated ras developed at GlobeImmune, Inc. will be supplied to NCI for pre-clinical studies. • [*] In vivo studies: In vivo studies will be performed by [*] to test the immunogenicity of mutually selected recombinant Tarmogens in preclinical animal models. [*] will investigate the immunogenicity of Tarmogens expressing CEA and other mutually agreed upon yeast recombinant vaccines in several NCI-developed animal models, [*]: • [*]; • [*]; • [*]; • [*]; • [*]; and • [*]. [*] GlobeImmune, Inc. will engineer Tarmogens to optimally express CEA and other mutually agreed upon tumor-associated antigens and will provide sufficient amounts of the Tarmogens to [*] to enable [*] to perform the necessary preclinical studies.
Preclinical Studies. The preclinical tests and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, Registration Statement and the Prospectus were and, if still pending, are being conducted in all material respects in accordance with all applicable laws and regulations; each description of the results of such studies contained in the Registration Statement and the Prospectus is accurate in all material respects, and the Company has no knowledge of any other studies the results of which are inconsistent with, or otherwise reasonably call into question, the results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described and the stage of development; and the Company has not received any written notice of, or written correspondence from, any governmental or regulatory authority requiring the termination, suspension or material modification of any studies that are described or referred to in the Registration Statement and the Prospectus.
Preclinical Studies. SALARIUS shall use its reasonable commercial efforts to complete preclinical development and file an IND under the US FDA. SALARIUS shall provide the preclinical study reports, data, and copy of the IND to HLBLS. HLBLS shall use its reasonable commercial efforts to file an Investigational New Drug (“IND”) application to initiate clinical studies of Licensed Products under the MFDS within two (2) years after receiving the US FDA IND and preclinical study data.
Preclinical Studies. In the event that as of the date a notice of termination has been issued Zai is conducting any ongoing preclinical work with respect to the Licensed Product in support of a current Regulatory Approval or future regulatory filings for an Indication that is the subject of ongoing clinical development, including without limitation ongoing stability or toxicology studies of the Licensed Product, Xxx agrees to promptly inform Xxxxxx of the status of each preclinical activity and at Karuna’s election either: (A) terminate such preclinical activity, (B) continue to conduct any such preclinical studies for a period of no more than [***] after the effective date of such termination, or (C) promptly transition to Karuna or its designee such preclinical studies, in each case, [***], unless this Agreement is terminated by Zai pursuant to Section 13.3, in which case Karuna shall be responsible for all such costs.
