Animal Experiments Sample Clauses

Animal Experiments. University will conduct at least three (3) animal experiments per month, unless Sponsor consents in writing to a lesser number of experiments for any particular month. University will provide the goals and objectives of each animal experiment to Sponsor, in writing at least one (1) day prior to the experiment, for Sponsor’s review, comment and approval. Within two (2) days after each animal experiment, University will provide Sponsor a written summary that describes the experiment (including key observations and findings from the experiment) and indicates whether the goals and a objectives of the experiment were achieved.
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Animal Experiments. A number of animal experiments have demonstrated a wide range of health outcomes from exposure to PCBs, mercury and chlorinated dibenzo-p-dioxins (CDD). PCBs (polychlorinated biphenyls): Animals exposed orally to PCBs developed effects to the hepatic, immunological, neurological, developmental and reproductive systems. Effects have also been reported in the gastrointestinal and hematological systems (ATSDR 1998). Animal ingestion studies strongly support the finding that more highly chlorinated PCBs (i.e., 60% chlorine by weight) are carcinogenic to the livers of rats, while the lower chlorinated PCBs are weaker animal carcinogens (i.e. lower incidence of total tumors and more benign tumors) (Xxxxxxxx et al.,, 1991; Xxxxxxx et al.,, 1992). Mercury: Long-term, high level animal ingestion exposure to mercury has been associated with cardiovascular (Xxxxx and Xxxxxxxxx, 1991), developmental (Xxxxxx et al.,, 1978; Xxxxx et al.,, 1972; Xxxxxx et al.,,1985), gastrointestinal (Xxxxxxxxx et al.,, 1990), immune (Xxxxxx, 1991), renal (Xxxxxxxx et al.,, 1991; Xxxxx et al.,, 1985; Xxxxx and Xxxxxx, 1972; Xxxxxx, 1972) and reproductive effects (Xxxxxxxxx et al.,, 1988; Xxxxxxxxx et al.,, 1990; Xxxxxxx et al.,, 1987). The studies also indicate that the nervous system is particularly sensitive to mercury exposure by ingestion (Xxxxxx et al.,, 1978; Xxxxx et al.,, 1980, 1985). In addition, growth of kidney tumors has been reported in animals administered methylmercury in drinking water or diet for extended periods (Mitsumori et al.,, 1981, 1990). CDDs (chlorinated dibenzo-p-dioxins): In specific species (e.g. guinea pig), very low levels of 2,3,7,8-TCDD (2,3,7,8-tetrachlorodibenzo-p-dioxin) have resulted in the death of the exposed animal after a single ingestion dose (NTP, 1982). At non-lethal levels of 2,3,7,8- TCDD by ingestion, other effects reported in animals include weight loss (NTP, 1982), biochemical and degenerative changes in the liver (NTP, 1982; Xxxxxx et al.,, 1978), and a decline in blood cells (Xxxxxx et al.,, 1978). Dermal effects in animals (e.g. hair loss, chloracne) have also been reported by ingestion exposure (XxXxxxxxx et al.,, 1978). In many species, the immune system and fetal development are particularly susceptible to 2,3,7,8-TCDD exposure. Offspring of animals receiving oral exposure to 2,3,7,8-TCDD developed birth defects such as skeletal deformities and kidney defects, weakened immune responses, impaired reproductive system development, and l...

Related to Animal Experiments

  • Development Records Each Party shall maintain complete, current and accurate records of all Development activities conducted by it hereunder, and all data and other information resulting from such activities. Such records shall fully and properly reflect all work done and results achieved in the performance of the Development activities in good scientific manner [*]. Each Party shall document all non-clinical studies and clinical trials in formal written study reports according to applicable Laws and national and international guidelines (e.g., ICH, GCP, GLP, and GMP). Each Party shall have the right to review and copy such records maintained by the other Party at reasonable times and to obtain access to the original [*].

  • Reverse Engineering The Customer must not reverse assemble or reverse compile or directly or indirectly allow or cause a third party to reverse assemble or reverse compile the whole or any part of the software or any products supplied as a part of the Licensed System.

  • Research Support opioid abatement research that may include, but is not limited to, the following:

  • Development Activities The Development activities referred to in item “b” of paragraph 3.1 include: studies and projects of implementation of the Production facilities; drilling and completion of the Producing and injection xxxxx; and installation of equipment and vessels for extraction, collection, Treatment, storage, and transfer of Oil and Gas. The installation referred to in item “c” includes, but is not limited to, offshore platforms, pipelines, Oil and Gas Treatment plants, equipment and facilities for measurement of the inspected Production, wellhead equipment, production pipes, flow lines, tanks, and other facilities exclusively intended for extraction, as well as oil and gas pipelines for Production Outflow and their respective compressor and pumping stations.

  • Studies The clinical, pre-clinical and other studies and tests conducted by or on behalf of or sponsored by the Company or its subsidiaries that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus were and, if still pending, are being conducted in accordance in all material respects with all statutes, laws, rules and regulations, as applicable (including, without limitation, those administered by the FDA or by any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA). The descriptions of the results of such studies and tests that are described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus are accurate and complete in all material respects and fairly present the published data derived from such studies and tests, and each of the Company and its subsidiaries has no knowledge of other studies or tests the results of which are materially inconsistent with or otherwise call into question the results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus. Except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, neither the Company nor its subsidiaries has received any notices or other correspondence from the FDA or any other foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA with respect to any ongoing clinical or pre-clinical studies or tests requiring the termination or suspension of such studies or tests. For the avoidance of doubt, the Company makes no representation or warranty that the results of any studies, tests or preclinical or clinical trials conducted by or on behalf of the Company will be sufficient to obtain governmental approval from the FDA or any foreign, state or local governmental body exercising comparable authority.

  • Development Work The Support Standards do not include development work either (i) on software not licensed from CentralSquare or (ii) development work for enhancements or features that are outside the documented functionality of the Solutions, except such work as may be specifically purchased and outlined in Exhibit 1. CentralSquare retains all Intellectual Property Rights in development work performed and Customer may request consulting and development work from CentralSquare as a separate billable service.

  • Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.

  • Development Costs With respect to activities prior to the Amendment Effective Date, each Party was to pay [*] of the total Direct Development Costs of a Product incurred in accordance with the Development Budget (as defined in the Original Agreement). Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, with respect to activities on and after the Amendment Effective Date, subject to Sections 3.1.2, Alimera will be solely responsible for, and shall pay one hundred percent (100%) of, all development costs of a Product, including Direct Development Costs. Notwithstanding anything in this Article 6 of this Agreement or in any other provision of this Agreement to the contrary, (i) all payments owing by CDS hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by CDS (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), further including any penalties and interest which might have accrued with respect thereto, and further including all CDS payments deferred pursuant to that February 11, 2008 letter agreement sent by CDS and executed by CDS and Alimera regarding deferral of payments under the Original Agreement as of such date; (ii) all payments owing by Alimera hereunder with respect to development activities prior to the Amendment Effective Date are hereby deemed fully paid by Alimera (or waived, to the extent such waiver may be required), including any Development Payments, Compounded Development Payments, Determined Disputed Costs and Compounded Disputed Costs (as all defined in the Original Agreement), and further including any penalties and interest which might have accrued with respect thereto; and (iii) subject to Sections 3.1.1 and 3.1.2, from and after the Amendment Effective Date, CDS will have no liability whatsoever hereunder for any past, present or future development costs, including Direct Development Costs (which includes those incurred before, on and after the Amendment Effective Date), and instead Alimera shall have sole liability therefor.

  • Development Program A. Development activities to be undertaken (Please break activities into subunits with the date of completion of major milestones)

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