Study Drug a) Institution and Investigator will be provided with sufficient amounts of the Study Drug solely for the purposes of the conduct of the Study, free of charge. Available information on the Study Drug, which Xxxxxxx considers výzkumného personálu pro sběr, zpracování, ukládání a přenos jejich osobních údajů pro výše uvedené účely.
Study Drug. Company agrees that it will provide Group (indirectly through NCI) with the quantities of the Company’s investigational drug product entinostat and placebo (the “Study Drug”) required to conduct the Study in accordance with the Protocol, at no charge. Group shall use, and will ensure that Study Personnel (as defined in Section 4.D) use, the Study Drug solely for purposes of the Study in accordance with the Protocol. In handling, storing and using Study Drug, Group members will comply with all applicable laws and any written instructions provided by Company (or by NCI on behalf of Company). All Study Drug supplied to Group members will remain the exclusive property of Company until administered or dispensed to any of the patients involved in the Study (“Study Subjects”) during the course of the Study. Group members will keep the Study Drug in a safe and secure location and maintain complete and accurate records showing disposition of the Study Drug. Group members will not provide access to Study Drug to anyone except Study Personnel. Group will not chemically, physically or otherwise modify Study Drug.
Study Drug. Sponsor (directly or through its designee) agrees to provide the Study Drug to Institution, at no cost to Institution, in amounts reasonably sufficient for the conduct of the Study as anticipated by the Protocol. Institution shall maintain exclusive control of the Study Drug and handle and store the Study Drug in accordance with Applicable Laws and in the manner outlined in the Protocol. Institution shall use the Study Drug solely for the purpose of conducting the Study in strict adherence to the Protocol and for no other use or purpose, and shall under no circumstance transfer the Study Drug to any third party. Institution will not charge a subject or third party payer for the Study Drug or other items or Materials (as defined below) reimbursed by Sponsor under this Agreement. Hodnocený přípravek. Zadavatel (přímo nebo přes svou pověřenou osobu) souhlasí, že bude poskytovat Hodnocený přípravek Zdravotnickému zařízení, přičemž ten bude Zdravotnickému zařízení dodáván zdarma v množství, které je rozumně dostatečné pro provádění Studie podle předpokladů Protokolu. Zdravotnické zařízení bude výhradně disponovat s Hodnoceným přípravkem a provádět manipulaci a uchovávání Hodnoceného přípravku v souladu s Příslušnými právními předpisy způsobem uvedeným v Protokolu. Zdravotnické zařízení bude používat Hodnocený přípravek výhradně pro účel provádění Studie přísně v souladu s Protokolem a pro žádné jiné použití nebo účel a za žádných okolností nepředá Hodnocený přípravek jakékoli třetí straně. Zdravotnické zařízení nebude účtovat subjektu nebo plátci třetí strany Hodnocený přípravek nebo jiné položky nebo Materiály (jak je definováno níže) hrazené Zadavatelem podle této Smlouvy.
Study Drug. 1) Study Drug is an exclusive property of the Sponsor. The Principal Investigator and Institution shall use the Study Drug only to conduct the Study in accordance with the Protocol, and for no other purpose.
Study Drug. (a) The Protocol is to be performed with XXXXX (“Study Drug”). MedImmune will make Study Drug available to Institution, as further specified under item (d) below, at no cost or expense to the Institution or Investigator. Where applicable national laws exclude the provision of any Study Materials by MedImmune to the Institution and Investigator free of charge, the Parties shall consult to arrive at a suitable arrangement as to the supply of the Study Drug by MedImmune to the Institution. After MedImmune has: (i) received a copy of the approval of the Protocol from the relevant ethics authority of Institution, including the approved subject informed consent form; (ii) received a copy of the authorization to disclose individually identifiable health information, as applicable; (iii) received a financial disclosure form (iv) received other essential Study documents as needed; and (v) Institution has been qualified to conduct the Study by MedImmune and or its designated representative; the Study Drug will be shipped to the Institution / Pharmacy, as defined in item (d) below and will be managed by the Investigator and delegated pharmacist, as defined in item (d) below, or their qualified designee according to the Protocol. Institution may not charge any Study Subject, nor charge or seek reimbursement from any person or entity, including insurance companies, any third party payer (whether public or private) or Institution representatives, for the Study Drug (including comparator or placebo) provided by MedImmune or the administration of such Study Drug. (b) Institution and Investigator will use the Study Drug solely for the purpose of conducting the Study in accordance with the Protocol. Upon completion of the Study or at the request of MedImmune or its designated representative, Institution and/or Investigator will promptly destroy or return, at MedImmune’s expense, all unused Study Drug to MedImmune and/or its designated representatives and provide documentation, upon request by MedImmune and/or its designated representatives, certifying the destruction or return of such Study Drug. (c) In the event that MedImmune determines that the Study Drug must be recalled for safety, identity, purity, strength, quality or other concerns, MedImmune will issue a notice to the Institution specifying that there is a recall. Such notice will contain instructions for how to pack and ship the Study Drug and instructions for completing necessary paperwork including accountabilit...
Study Drug. The Study Drug for this Clinical Trial -------------------- for which an application to conduct clinical trial has been filed with DCGI, and seeking for approval.
Study Drug. (a) The Protocol is to be performed with (“Study Drug”). MedImmune will make Study Drug available to Institution, as further specified under item (d) below, at no cost or expense to the Institution or Investigator. Where applicable national laws exclude the provision of any Study Materials by MedImmune to the Institution and Investigator free of charge, the Parties shall consult to arrive at a suitable arrangement as to the supply of the Study Drug by MedImmune to the Institution. After MedImmune has: (i) received a copy of the approval of the Protocol from the relevant ethics authority of Institution, including the approved subject informed consent form; (ii) received a copy of the authorization to disclose individually identifiable health information, as applicable; (iii) received a financial disclosure form (iv) received other essential Study documents as needed; and
Study Drug a. AIM will furnish an agreed upon number of vials of Study Drug, approximately *** vials, *** to the Institution pursuant to this Agreement solely for use in the Protocol. ***
Study Drug administration and/or any patient participation in any Study or Project Exhibit may be terminated, in whole or in part, by Corcept immediately upon written notice to Scirex, if any of the following conditions occur:
Study Drug. Sponsor (directly or through its designee), agrees to provide the Study Drug to Institution, at no cost to Institution, in amounts reasonably sufficient for the conduct of the Study as anticipated by the Protocol. Institution shall maintain exclusive control of the Study Drug and handle and store the Study Drug in accordance with Applicable Laws and in the manner outlined in the Protocol. Institution and Investigator shall use the Study Drug solely for the purpose of conducting the Study in strict adherence to the Protocol and for no other use or purpose, and shall under no circumstance transfer the Study Drug to any third party. Neither Institution nor Investigator will charge a subject or third party payer for the Study Drug or other items or Materials (as defined below) reimbursed or provided by Sponsor under this Agreement. The Study Drug shall be stored in accordance with Decree No. 226/2008 Coll., as amended, in the Institution´s pharmacy (the “Pharmacy”), which undertakes to adhere to good pharmacy practice rules and SÚKL guidelines. Pharmacy guarantees that Study Drug disposal shall be only performed by authorised personnel. Pharmacy shall be responsible for accepting the Study Drug and dispensing of the Study Drug to the Investigator or his designee. Unused Study Drug shall be disposed of (liquidated) by the Institution in accordance with Applicable laws (along with other medication used in the Study). This provision relates to all medication provided by the Sponsor within the Study, that has expired period for use. Hodnocený přípravek. Zadavatel (přímo nebo přes svou pověřenou osobu) souhlasí, že bude poskytovat Hodnocený přípravek Poskytovateli zdravotních služeb, přičemž ten bude Poskytovateli zdravotních služeb dodáván zdarma v množství, které je rozumně dostatečné pro provádění Studie podle předpokladů Protokolu. Poskytovatel zdravotních služeb bude výhradně disponovat s Hodnoceným přípravkem a provádět manipulaci a uchovávání Hodnoceného přípravku v souladu s Příslušnými právními předpisy způsobem uvedeným v Protokolu. Poskytovatel zdravotních služeb a Zkoušející budou používat Hodnocený přípravek výhradně pro účel provádění Studie přísně v souladu s Protokolem a pro žádné jiné použití nebo účel a za žádných okolností nepředají Hodnocený přípravek jakékoli třetí straně. Ani Poskytovatel zdravotních služeb ani Zkoušející nebudou účtovat subjektu nebo plátci třetí strany Hodnocený přípravek nebo jiné položky nebo Materiály (jak je definováno n...
