Use of Biological Materials. Licensee agrees that its use of any Licensed Biological Materials shall comply with all applicable statutes, regulations, and guidelines. Licensee agrees not to use the Licensed Biological Materials for research involving human subjects or clinical trials in the United States without complying with 21 CFR 50 and 45 CFR 46. Licensee agrees not to use the Licensed Biological Materials for research involving human subjects or clinical trials outside of the United States without complying with the applicable regulations of the appropriate national control authorities.
Use of Biological Materials. Licensee, any Affiliate(s) and any Sublicensees whose sublicenses are not converted as provided in paragraph 8.4.5, shall cease to use the Biological Materials and shall certify their proper and humane disposition.
Use of Biological Materials. With respect to Licensee’s use of any Licensed Biological Materials, Licensee hereby agrees to comply with all applicable statutes, regulations, and guidelines. ***Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. Licensee agrees not to use the materials for research involving human subjects or clinical trials in the United States without complying with 21 CFR 50 and 45 CFR 46. Licensee agrees not to use the materials for research involving human subjects or clinical trials outside of the United States without complying with the applicable regulations of the appropriate national control authorities.
Use of Biological Materials. The Recipient shall: use the Biological Materials in accordance with good laboratory practice and the highest standards of skill and care; and ensure the storage and use by the Recipient of the Biological Materials comply with all relevant laws, codes of practice and ethical principles. In particular, the Recipient must not use the Biological Materials in any research or trials involving human subjects and animal subjects without UKM’s prior express consent in writing.
Use of Biological Materials. Targeted Genetics grants Collateral the right to use the Biological Materials only for proposed use, as set forth in the work plan attached to this Agreement as Appendix A ("Work Plan"). Collateral shall not transfer the Biological Materials to third parties. The Biological Materials shall not be used in humans, and shall be used in compliance with applicable federal, state and local laws and regulations. The Biological Materials shall not be used in research that is subject to consulting or licensing obligations to a corporation, unless prior written permission is obtained from Targeted Genetics.
Use of Biological Materials. As of the date of this Agreement, Corixa grants to PMC a non-exclusive license to use the Biological Materials for the Proposed Use for research purposes and not for any commercial use. PMC shall not use the Biological Materials in humans or in contact with any cells or other materials to be infused into humans. PMC shall use the Biological Materials in compliance with all applicable federal, state and local laws and regulations. PMC shall not transfer the Biological Materials or any information related to those materials to any person who is not under the immediate and direct supervision of PMC, nor use the Biological Materials in research that is subject to consulting or licensing obligations to another corporation or government agency. No other license shall be granted or implied.
Use of Biological Materials. Sponsor or a duly authorized agent of Sponsor, shall supply Institution with sufficient amount of Investigational Product as described in the Protocol. Institution acknowledges that Sponsor owns the Investigational Product, and any placebo and comparator drug (if applicable). The Institution shall use the Investigational Product and any comparator products provided in connection with the Study, solely for the purpose of properly completing the Study and shall maintain the Investigational Product as specified by Sponsor and according to applicable laws and regulations, including storage in a locked, secured area at all times. Zkoušející a/nebo Studijní personál mohou být vyzváni, aby se zúčastnili schůzek ke Studii. Smluvní strany se dohodly, že za účast na takových schůzkách nebude Zkoušejícímu nebo Studijnímu personálu vyplácena žádná odměna navíc. Budou-li Zkoušející nebo Studijní personál pověřeni, aby provedli nějaké další úkony nad rámec těch, které jsou požadovány v rámci provádění Studie, budou podmínky poskytování takových služeb upraveny v samostatné smlouvě. 1.5 Nežádoucí příhody Místo provádění klinického hodnocení uvědomí v čase stanoveném v Protokolu společnost IQVIA a Zadavatele o závažné nežádoucí příhodě a o jakémkoli nároku ve vztahu k jakémukoli onemocnění nebo újmě skutečně nebo údajně vzniklým v důsledku nežádoucí reakce na Hodnocené léčivo v souladu s požadavky Protokolu a příslušnými právními předpisy a nařízeními. Zkoušející se zavazuje, že bude spolupracovat se Zadavatelem v souvislosti s jeho úsilím vynaloženém v rámci kontrolního procesu ve vztahu k jakékoli nežádoucí příhodě. Místo provádění klinického hodnocení bude jednat v souladu s oznamovacími povinnostmi vyžadovanými jeho LEK. Zadavatel bez zbytečného odkladu vyrozumí LEK Zdravotnického zařízení a IQVIA, ohledně jakéhokoli zjištění, jež je způsobilé ovlivnit bezpečenost účastníků či jejich vůli a ochotu pokračovat v účasti ve Studii, mít vliv na provádění Studie, či změnit vydané souhlasné stanovisko LEK Zdravotnického zařízení vztahující se k pokračování ve Studii. 1.6 Použití a vrácení Hodnoceného léčiva a Materiálů. Používání biologických materiálů. Zadavatel, či jeho řádně oprávněný zástupce, dodá Zdravotnickému zařízení dostatečné množství Hodnoceného léčiva dle podmínek popsaných v Protokolu. Zdravotnické zařízení bere na vědomí, že vlastníkem Hodnoceného přípravku, placeba či srovnávacího přípravku (budou-li používány) je Zadavatel. Zdravotnické zařízení bude používa...
Use of Biological Materials. Licensee agrees that its and its Sublicensees’ use of any Licensed Biological Materials shall comply with all applicable laws, rules, regulations and guidelines. Licensee agrees that the Licensed Biological Materials will not be used for research involving human subjects or clinical trials in the United States without complying with 21 C.F.R. Part 50 and 45 C.F.R. Part 46. Licensee agrees that the Licensed Biological Materials will not be used for research involving human subjects or clinical trials outside of the United States without complying with the applicable foreign laws, rules and regulations.
Use of Biological Materials. As of the date of this Agreement, Corixa grants to SBBIO a non-exclusive license to use the Biological Materials for the Proposed Use for research purposes and not for any commercial use. SBBIO shall not use the Biological Materials in humans or in contact with any cells or other materials to be infused into humans. SBBIO shall use the Biological Materials in compliance with all applicable federal, state and local laws and regulations. SBBIO shall not transfer the Biological Materials or any information related to those materials to any person who is not under the immediate and direct supervision of SBBIO, nor use the Biological Materials in research that is subject to consulting or licensing obligations to another corporation or a government agency. For consideration received from SBBIO pursuant to separately executed breast cancer ("BC") and prostate cancer ("PC") collaboration and license agreements, dated 1 March1997 (the "BC and PC Agreements"), Corixa shall provide an option to license the aforementioned Biological Materials on the terms described in the attached Schedule 4. Such option shall be maintained for the duration of any funded research pursuant to the BC and/or PC Agreements, as applicable, as amended from time to time. At any time during which BC or PC research is funded by SBBIO at Corixa pursuant to the BC and/or PC Agreements, as applicable, SBBIO may, in writing, notify Corixa of its intent to exercise its option right to execute a license agreement for the Biological Materials. Such agreement shall contain terms consistent with those in Schedule 4, and be negotiated in good faith within three (3) months of SBBIO's written notice of its intent to exercise the option. Nothing herein contained shall be construed as an obligation upon SBBIO to enter into any license agreement with Corixa with respect to the Biological Materials. DURING THE TERM OF THIS AGREEMENT, CORIXA MAY, AT ANY TIME AND WITHOUT ANY PRIOR COMMUNICATION WITH SBBIO, EXECUTE A NON-EXCLUSIVE COMMERCIAL LICENSE ARRANGEMENT, RELATED TO THE BIOLOGICAL MATERIALS FOR ANY USE INCLUDING, BUT NOT LIMITED TO, IN BC OR PC, WITH A THIRD PARTY.
Use of Biological Materials. (a) The Institute agrees that biological materials to be obtained from human subjects for purposes of conducting Research Projects shall be obtained only after all necessary review and final approvals by the appropriate institutional review board, human experimentation committee or similar body have been obtained, said process specifically to include review and final approval of the consent form(s) to be used to document that the human subject has had an opportunity to be informed about the nature of and the potential risks and benefits associated with the research and has decided to provide biological materials knowing that such biological materials will be analyzed by the Institute and Consortium Members and may be retained by Institute and/or Consortium Members.
