Pre-Clinical Studies. GRELAN agrees at its sole expense to sponsor and conduct (or have sponsored and conducted) all necessary additional pre-clinical and non-clinical studies and tests required by the Japanese Ministry of Health and Welfare (the "MHW") or other local regulatory agency in the Territory in connection with commencing and conducting human clinical trials with respect to the Venture Products in the Territory and with respect to the manufacture (or importation into the Territory), sale and distribution of Venture Products in the Territory. BIONUMERIK will provide free of charge to KI PHARMA and GRELAN all pre-clinical data, clinical research protocols, and clinical trials data and information previously or hereafter developed by BIONUMERIK that were used and/or are necessary to support United States Food and Drug Administration ("FDA") regulatory submissions to support regulatory applications for the Venture Products BN in the Territory. GRELAN will provide free of charge to KI PHARMA and BIONUMERIK all pre-clinical data, clinical research protocols, and clinical trials data and information previously or hereafter developed by GRELAN that are necessary to support regulatory submissions to support regulatory applications for the Venture Products GR in the Territory.
Pre-Clinical Studies. Details must be provided on all biocompatibility tests conducted on materials used in a device. At a minimum, tests must be conducted on samples from the finished, sterilized device. All materials that are significantly different must be characterized. Information describing the tests, the results and the analyses of data must be presented. Complete pre-clinical physical test data must be provided, as appropriate. The report must include the objectives, methodology, results and product owner’s conclusions of all physical studies of the device and its components. Physical testing must be conducted to predict the adequacy of device response to physiological stresses, undesirable conditions and forces, long- term use and all known and possible failure modes. Pre-clinical animal studies used to support the probability of effectiveness in humans must be reported. These studies must be undertaken using good laboratory practices. The objectives, methodology, results, analysis and product owner’s conclusions must be presented. The study conclusion should address the device's interactions with animal fluids and tissues and the functional effectiveness of the device in the experimental animal model(s). The rationale (and limitations) of selecting the particular animal model should be discussed.
Pre-Clinical Studies. Maruho may, at its sole discretion and at its sole expense, carry out non-GLP pre-clinical pharmacology and non-GLP pharmacokinetics/pharmacodynamics studies in Japan, either by itself or through CRO or research institutions, which studies will be coordinated in the JDC. If the JDC reasonably considers that such study may raise adverse regulatory implications on the global development level, the JDC may object to the intended study and will use best efforts to make risk reduction modifications.
Pre-Clinical Studies. Pre-clinical studies include laboratory evaluation of product chemistry, toxicity, and formulation, as well as animal studies to assess potential safety and efficacy. An IND sponsor must submit the results of the pre-clinical tests, together with manufacturing information, analytical data, and any available clinical data or literature, among other things, to the FDA as part of an IND. Some pre-clinical testing may continue even after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the clinical trial on a clinical hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can begin. As a result, submission of an IND may not result in the FDA allowing clinical trials to commence. Clinical holds also may be imposed by the FDA at any time before or during clinical trials, due to safety concerns about on-going or proposed clinical trials, or non-compliance with specific FDA requirements, and the trials may not begin or continue until the FDA notifies the sponsor that the hold has been lifted. Through the 505(b)2 regulatory path, the FDA allows a sponsor to rely on well documented, published studies to support the clinical development of the product. The FDA has indicated that it will accept published data in support of the Company’s development program for JAN101 but prior to filing an NDA would require the Company to complete developmental and reproductive toxicology studies.
Pre-Clinical Studies. Licensor agrees to complete, and bear the full cost of, the pre-clinical studies specified on Exhibit 3.3.1 in support of Developing the Licensed Products in the Americas/Europe Territory. Licensor shall use its Commercially Reasonable Efforts to complete such studies prior to the first filing of the NDA or MAA as set forth in the Initial Americas/Europe Development Plan. The costs of any other pre-clinical studies performed by Licensor in connection with obtaining Regulatory Approvals in the Americas/Europe Territory shall be borne equally by Licensor and Licensee.
Pre-Clinical Studies. The pre-clinical studies and tests conducted by or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the Company, or in which the Company has participated, that are described in the 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, were, and, if still pending, are, being conducted in all material respects in accordance with standard industry practice and any applicable rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); the descriptions in the Registration Statement, the General Disclosure Package or the Prospectus of the results of such studies or tests are accurate and complete in all material respects and fairly present the data derived from such studies or tests; 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 reasonably call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency with jurisdiction over it requiring or threatening the termination, material modification or suspension of any pre-clinical studies or tests that are described in the 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such pre-clinical studies or tests.
Pre-Clinical Studies. In connection with the further development activities conducted pursuant to Article III or as may be required for approval of the Solesta Product in the U.S., Q-Med, itself or through Third Parties, shall conduct all pre-clinical development activities concerning the biocompatible gel composition containing polymerized and cross-linked hyaluronic acid, derived from a non-animal source, and dextranomer microspheres used as a Licensed Product (or as an ingredient thereof) that are necessary for achieving Regulatory Approval of such Licensed Product in the U.S. for any indication in the Licensed Field. Q-Med will bear all Development Costs for all such current pre-clinical studies required to be conducted by the FDA relating to the approval of the first Solesta Product in the U.S. Should FDA require additional pre-clinical studies to be performed, the parties shall share the costs for such additional pre-clinical studies.
Pre-Clinical Studies. Upon designation of each IND Candidate, the JRC or Project Team shall oversee the IND-enabling work for such IND Candidate including GLP-safety studies, CMC and formulation development. Each Party shall participate based upon expertise and facilities (such as GLP toxicology and GMP chemical manufacturing). PTC may work on non-GLP characterization of IND Candidates during this phase. In addition, the JRC or Project Team may propose, subject to JMC approval and the Parties’ agreement on economic terms, that PTC continue Lead Optimization to identify and characterize potential backup IND Candidates.
Pre-Clinical Studies. The pre-clinical studies and tests conducted by or, to the knowledge of the Company after due inquiry, on behalf of or sponsored by the Company, or in which the Company has participated, 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, as applicable, were, and, if still pending, are, being conducted in all material respects in accordance with standard industry practice and any applicable rules and regulations of the FDA and comparable drug regulatory agencies outside of the United States to which they are subject (collectively, the “Regulatory Authorities”); the descriptions in the Registration Statement or the Prospectus of the results of such studies or tests are accurate and complete in all material respects and fairly present the data derived from such studies or tests; the Company has no knowledge of any other studies or tests not described in the Registration Statement and the Prospectus, the results of which reasonably call into question the results described or referred to in the Registration Statement and the Prospectus; the Company has not received any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency with jurisdiction over it requiring or threatening the termination, material modification or suspension of any pre-clinical studies or tests 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, other than ordinary course communications with respect to modifications in connection with the design and implementation of such pre-clinical studies or tests.
