Receipt of the Investigational Product Obdržení Sample Clauses

Receipt of the Investigational Product Obdržení. Hodnoceného léčiva 7.1.1 The Investigator shall verify receipt of the Investigational Product by signing the appropriate document(s)/form(s) provided by CRO or Sponsor or a supplier designated by CRO or Sponsor. Zkoušející potvrdí obdržení Hodnoceného léčiva podepsáním příslušného dokumentu (příslušných dokumentů) /formuláře(ů) poskytnutých Zadavatelem, společností CRO nebo dodavatelem, který Zadavatel nebo společnost CRO určí. Sponsor through CRO shall ensure shipment of the Investigational Product shall be clearly identifiable, delivered to the Pharmacy of the Institution (“Pharmacy”) solely during business hours between 8.00 AM and 1:00 PM and pursuant to prior phone/e-mail communication (if possible 2 days in advance). Sponsor through CRO hereby acknowledge, that should the delivery not be notified in advance and delivered within the agreed time frame, it shall not be accepted. The scope of required pharmacy services and frequency of Investigational Product deliveries is defined in the Pharmacy Services Form of the Provider (Attachment B). Payments for these pharmacy services are set forth in Attachment A of this Agreement. Prior to the initiation of the Study, Sponsor through CRO shall acquaint the appointed pharmacist with the Study, provide relevant documentation required by law or by the State Institute for Drug Control or by any other regulatory authority (Protocol synopsis, Study File, Approval of the State Institute for Drug Control, Approvals of Ethics Committee(s) etc.) and acquaint the appointed pharmacist with any requirements regarding Investigational Product records at SIV. The Investigational Product shall not by accepted prior to SIV, i.e. official commencement of the Study. Sponsor shall retrieve and destroy any and all remaining unused Investigational Product and material from the Investigator related to the Study. Pharmacy shall not be required to Zadavatel prostřednictvím CRO zajistí, že zásilka Hodnoceného léčiva bude jednoznačně identifikována, dodána do lékárny Poskytovatele (xxxx xxx „Lékárna“) výhradně v běžné pracovní dny mezi 8.00-13.00 hod. a po předchozí telefonické/e-mailové domluvě (dle možností alespoň 2 dny předem). Zadavatel prostřednictvím CRO tímto bere na vědomí, že v případě, že zásilka nebude předem nahlášena a dodána v uvedeném časovém rozmezí, nebude převzata. Rozsah požadovaných lékárenských služeb a frekvence zásilek Hodnoceného léčiva je definována v dotazníku lékárenských služeb Poskytovatele (Příloha B). Pla...
Sample 1
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Receipt of the Investigational Product Obdržení. Hodnoceného léčiva 7.1.1 The Investigator shall verify receipt of the Investigational Product by signing the appropriate document(s)/form(s) provided by the Sponsor, ICON or a supplier designated by the Sponsor or ICON. Zkoušející potvrdí obdržení Hodnoceného léčiva podepsáním příslušného dokumentu (příslušných dokumentů) / formuláře(ů) poskytnutých Zadavatelem, společností ICON nebo dodavatelem, který Zadavatel nebo společnost ICON určí.
Sample 1
Receipt of the Investigational Product Obdržení hodnoceného léčiva The Institution acknowledges that Investigational Product is the property of the Sponsor. The Institution shall ensure that the Investigator or an authorized pharmacist shall verify receipt of the Investigational Product by signing the appropriate document(s)/form(s) provided by the Sponsor, ICON or a supplier designated by the Sponsor or ICON. The Investigational Product shall be supplied to the Institution’s pharmacy. The Investigational Product will be delivered to the Institution’s pharmacy during the pharmacy’s working hours, i.e., from 8:00 a.m. to 3:00 p.m. (Mon – Fri). Zdravotnické zařízení bere na vědomí, že hodnocené léčivo je majetkem zadavatele. Zdravotnické zařízení zajistí, že zkoušející nebo pověřený lékárník potvrdí obdržení hodnoceného léčiva podepsáním příslušných dokumentů či formulářů poskytnutých zadavatelem, společností ICON nebo dodavatelem určeným zadavatelem nebo společností ICON. Hodnocené léčivo bude dodáno do lékárny Zdravotnického zařízení. Hodnocené léčivo bude dodáváno do lékárny Zdravotnického zařízení v pracovní době lékárny, tj. od 8:00 do 15:00 h (po-pá).
Sample 1
Receipt of the Investigational Product Obdržení. Hodnoceného léčiva 7.1.1 The Investigator shall verify receipt of the Investigational Product by signing the appropriate document(s)/form(s) provided by CRO or Sponsor or a supplier designated by CRO or Sponsor. Zkoušející potvrdí obdržení Hodnoceného léčiva podepsáním příslušného dokumentu (příslušných dokumentů) /formuláře(ů) poskytnutých Zadavatelem, společností CRO nebo dodavatelem, který Zadavatel nebo společnost CRO určí. 7.1.2 Sponsor through CRO shall ensure the distribution of the Investigational Product to the pharmacy of the Institution, where it will be received and examined by the responsible pharmacist (in the same manner as any other shipment, i.e., whether the delivery is not damaged, whether specific requirements for transportation (if any) have been duly followed, and afterwards the receipt of shipment will be confirmed). Furthermore, the Investigator shall collect and take full responsibility for the delivery upon its receipt at the Institution. Zadavatel prostřednictvím CRO zajistí distribuci Hodnoceného léčiva do lékárny Zdravotnického zařízení, kde je odpovědný farmaceut převezme a zkontroluje (jako jiné zásilky - tzn. není-li poškozena, v případě zvláštních požadavků na transport, byly-li tyto požadavky dodrženy, příjem zásilky potvrdí). Následně je po převzetí zásilky ve Zdravotnickém zařízení Zkoušející za zásilku plně zodpovědný. Sponsor through CRO shall notify the Instiution in advance, when a shipment is scheduled to be delivered. This notification shall be done either by e-mail to the following address: and or by phone. Sponsor through CRO shall deliver the shipment to the following address: OVV Zadavatel prostřednictvím CRO je povinen s přiměřeným předstihem oznámit před dodáním zásilky, kdy bude zásilka do lékárny předána buďto emailem na a nebo telefonicky. Zadavatel prostřednictvím CRO zajistí dodávku na adresu: OVV I, U Nemocnice 499/2, Xxxxx 0, Xxxxx I, U Xxxxxxxxx 000/0, Xxxxx 0, Xxxxx Xxxxxxxx, responsible pharmacist . republika, odpovědný farmaceut . Sponsor through CRO declares that all legal requirements and rules of good distribution practices regarding productions (import), labelling, packaging and distribution of the Investigational Product have been met. Zadavatel prostřednictvím CRO prohlašuje, že pro výrobu (dovoz) dodaných léčivých přípravků, jejich označování, balení a distribuci do Zdravotnického zařízení jsou splněny veškeré podmínky stanovené příslušnými právními předpisy a správnou distribuční praxí. Spo...
Sample 1

Related to Receipt of the Investigational Product Obdržení

  • Regulatory Examinations The Sub-Advisor will cooperate promptly and fully with the Advisor and/or the Trust in responding to any regulatory or compliance examinations or inspections (including information requests) relating to the Trust, the Fund or the Advisor brought by any governmental or regulatory authorities having appropriate jurisdiction (including, but not limited to, the SEC).

  • Search, Enquiry, Investigation, Examination And Verification a. The Property is sold on an “as is where is basis” subject to all the necessary inspection, search (including but not limited to the status of title), enquiry (including but not limited to the terms of consent to transfer and/or assignment and outstanding charges), investigation, examination and verification of which the Purchaser is already advised to conduct prior to the auction and which the Purchaser warrants to the Assignee has been conducted by the Purchaser’s independent legal advisors at the time of execution of the Memorandum. b. The intending bidder or the Purchaser is responsible at own costs and expenses to make and shall be deemed to have carried out own search, enquiry, investigation, examination and verification on all liabilities and encumbrances affecting the Property, the title particulars as well as the accuracy and correctness of the particulars and information provided. c. The Purchaser shall be deemed to purchase the Property in all respects subject thereto and shall also be deemed to have full knowledge of the state and condition of the Property regardless of whether or not the said search, enquiry, investigation, examination and verification have been conducted. d. The Purchaser shall be deemed to have read, understood and accepted these Conditions of Sale prior to the auction and to have knowledge of all matters which would have been disclosed thereby and the Purchaser expressly warrants to the Assignee that the Purchaser has sought independent legal advice on all matters pertaining to this sale and has been advised by his/her/its independent legal advisor of the effect of all the Conditions of Sale. e. Neither the Assignee nor the Auctioneer shall be required or bound to inform the Purchaser of any such matters whether known to them or not and the Purchaser shall raise no enquiry, requisition or objection thereon or thereto.

  • Eye Examinations All represented employees, who are health service system members, shall be eligible for one (1) annual VDT examination and prescribed eyewear.

  • 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.

  • Regulatory Investigations TCI and TLIC agree to cooperate fully in any insurance or judicial regulatory investigation or proceeding arising in connection with Contracts distributed under this Agreement. TCI and TLIC further agree to cooperate fully in any securities regulatory inspection, inquiry, investigation or proceeding or any judicial proceeding with respect to TLIC, TCI, their affiliates and their representatives to the extent that such inspection, inquiry, investigation or proceeding or judicial proceeding is in connection with Contracts distributed under this Agreement. Without limiting the foregoing: (a) TCI will be notified promptly of any customer complaint or notice of any regulatory inspection, inquiry investigation or proceeding or judicial proceeding received by TLIC with respect to TCI or any representative or which may affect TLIC’s issuance of any Contracts marketed under this Agreement; and (b) TCI will promptly notify TLIC of any customer complaint or notice of any regulatory inspection, inquiry, investigation or judicial proceeding received by TCI or any representative with respect to TLIC or its affiliates in connection with any Contracts distributed under this Agreement. In the case of a customer complaint, TCI and TLIC will cooperate in investigating such complaint and shall arrive at a mutually satisfactory response.

  • Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.

  • Product Changes Vocera shall have the right, in its absolute discretion, without liability to End User, to update to provide new functionality or otherwise change the design of any Product or to discontinue the manufacture or sale of any Product. Vocera shall notify End User at least 90 days prior to the delivery of any Product which incorporates a change that adversely affects form, fit or function (“Material Change”). Vocera shall also notify End User at least 90 days prior to the discontinuance of manufacture of any Product. Notification will be made as soon as reasonably practical for changes associated with regulatory or health and safety issues.

  • Regulatory Activities Beginning on the Effective Date and to the extent UGNX remains the Lead Development Party with respect to a particular territory, subject to and in accordance with the terms and conditions of this Agreement and the requirements of Applicable Laws, UGNX, shall: (a) use Commercially Reasonable Efforts to file (or have filed) all Regulatory Filings with respect to the Licensed Products in the Field in order to obtain Marketing Approvals in each country in the Territory and the European Territory (or to obtain the European Centralized Approval in the European Core Territory) and in order to obtain Pricing and/or Reimbursement Approvals in the Profit Share Territory; (b) respond in a timely fashion to requests for data and information from Regulatory Authorities with respect to the Licensed Products in the Field in the Territory and the European Territory; and (c) meet with officials of the Regulatory Authorities at such times as may be requested by such Regulatory Authorities with respect to the Core Development Activities (“Regulatory Activities”), provided that KHK will have primary responsibility for obtaining, and UGNX shall provide all assistance reasonably requested by KHK, in relation to Pricing and/or Reimbursement Approvals for the Licensed Products in the Field in the European Territory. For the avoidance of doubt, UGNX will be responsible for obtaining, and KHK will provide all assistance reasonably requested by UGNX, in relation to Pricing and/or Reimbursement Approvals, if any, for the Licensed Products in the Field in the Profit Share Territory as part of the UGNX Core Development Activities, it being understood that the costs incurred by UGNX in connection with such activities will be shared equally (50/50). All such Regulatory Activities will be conducted in a manner consistent with the Core Development Plan and coordinated by the JSC in accordance with Article 3. Without limiting the applicability of the foregoing and the remainder of this Article 5, UGNX shall interface with the applicable Regulatory Authority(ies) and, through the JDC, shall keep KHK reasonably informed of all material events and developments occurring in the course of the Regulatory Activities, including scheduled UGNX regulatory strategy discussions and meetings with Regulatory Authorities in the Territory and the European Territory relating to the Licensed Products in the Field.

  • Combination Products If a LICENSED PRODUCT is sold to any third party in combination with other products, devices, components or materials that are capable of being sold separately and are not subject to royalties hereunder (“OTHER PRODUCTS,” with the combination of products being referred to as “COMBINATION PRODUCTS” and the Other Product and Licensed Product in such Combination Product being referred to as the “COMPONENTS”), the NET SALES of such LICENSED PRODUCT included in such COMBINATION PRODUCT shall be calculated by multiplying the NET SALES of the COMBINATION PRODUCT by the fraction A/(A+B), where A is the average NET SALES price of such LICENSED PRODUCT in the relevant country, as sold separately, and B is the total average NET SALES price of all OTHER PRODUCTS in the COMBINATION PRODUCT in the relevant country, as sold separately. If, in any country, any COMPONENT is not sold separately, NET SALES for royalty determination shall be determined by the formula [C / (C+D)], where C is the aggregate average fully absorbed cost of the Licensed Product components during the prior Royalty Period and D is the aggregate average fully absorbed cost of the other essential functional components during the prior Royalty Period, with such costs being determined in accordance with generally accepted accounting principles. To the extent that any SUBLICENSE INCOME relates to a COMBINATION PRODUCT or is otherwise calculated based on the value of one or more licenses or intellectual property rights held by the COMPANY, an AFFILIATE or SUBLICENSEE, COMPANY shall determine in good faith and report to THE PARTIES the share of such payments reasonably attributable to COMPANY’s or such AFFILIATE’s sublicense of the rights granted hereunder, based upon their relative importance and proprietary protection, which portion shall be the SUBLICENSE INCOME. THE PARTIES shall have the right to dispute such sharing determination in accordance with the dispute provisions of the AGREEMENT.

  • Clinical Studies The animal and other preclinical studies and clinical trials conducted by the Company or on behalf of the Company were, and, if still pending are, to the Company’s knowledge, being conducted in all material respects in compliance with all Applicable Laws and in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical study and clinical trials of new drugs and biologics as applied to comparable products to those being developed by the Company; the descriptions of the results of such preclinical studies and clinical trials contained in the Registration Statement and the Prospectus are accurate and complete in all material respects, and, except as set forth in the Registration Statement and the Prospectus, the Company has no knowledge of any other clinical trials or preclinical studies, the results of which reasonably call into question the clinical trial or preclinical study 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 Company has not received any written notices or correspondence from the FDA, the EMA, or any other domestic or foreign governmental agency requiring the termination, suspension or modification of any preclinical studies or clinical trials conducted by or on behalf of the Company 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.

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