Performance of the Study Sample Clauses

Performance of the Study. 2.1 University shall perform the Study substantially in accordance with the terms and conditions of this Agreement. Sponsor and University may at any time amend the Study and this Agreement by mutual written consent. 2.2 In the event that the Principal Investigator becomes unable or unwilling to continue the Study and a mutually acceptable substitute is not available, both the University and the Sponsor shall have the option to terminate this Agreement. The Principle Investigator and any and all other person involved in the Study (collectively the "Investigator(s)" shall execute the Confidentiality Agreement substantially in the form attached hereto or Exhibit "B", (the "Confidentiality Agreement") prior to beginning any activities associated with the Study. 2.3 Nothing in the Agreement shall be construed to limit the freedom of Investigators, whether participants in this Agreement or not, from engaging in similar studies made independently under other grants, contracts or agreements with parties other than Sponsor, provided said investigations are not in conflict or violate the terms and conditions of this Agreement and the Confidentiality Agreement. 2.4 In performing the Study, University and Principal Investigator shall at all times undertake, comply with, and complete the following: 1. The Protocol; 2. This Agreement; 3. Generally accepted standards of good clinical practice; 4. Instructions provided in writing by Sponsor or Monitor; 5. All applicable federal, state and local laws and regulations applicable to the conduct of the Study and the performance of clinical investigators generally including but not limited to the Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug Administration; 6. Prepare an appropriate patient informed consent document sufficient to comply with all local, state, and federal statutory and regulatory requirements and in form acceptable to each of the parties, and thereafter to obtain such written consent from each patient or authorized representative prior to initiation of any procedures required by the Study; 7. Obtain and forward to Sponsor and Monitor evidence of Institutional Review Board ("IRB") approval of the Study and the informed consent document prior to beginning the Study; 8. Obtain and forward to Sponsor and Monitor evidence of ongoing review of the Study and informed consent document by the IRB at least annually; 9. Obtain and forward to Sponsor and Monitor evidence of IRB approval of any ad...
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Performance of the Study. The Protocol shall be considered final following approval by the IRBs/IECs (and by the Regulatory Authority if required by Applicable Laws). Institution will perform, and ensure that Institution Personnel will perform the Study in a timely manner in strict accordance with the Protocol, Applicable Laws, written instructions of the Sponsor or CRO and the terms and conditions of this Agreement including, but not limited to the Payment Terms and Budget attached hereto as Exhibit A, and any other attachments hereto. In the event of a conflict between the Protocol and this Agreement, the terms and conditions of the Protocol will prevail with respect to scientific issues relating to the Study. In all other instances, the terms and conditions of the Agreement will prevail. Institution agrees that if Investigator has not Enrolled at least one (1) Subject by the Key Enrollment Date, CRO (at the direction and authorization of Sponsor) may terminate this Agreement in accordance with Section 18.2. 2. Provádění studie 2.1. Provádění studie. Protokol bude považován za konečný po schválení IRB/NEK (a regulačním úřadem, pokud to vyžadují platné zákony). Zdravotnické zařízení studii provede, a zajistí, aby tak činil i personál zdravotnického zařízení, včas a v přísném souladu s protokolem, platnými právními předpisy, písemnými pokyny zadavatele nebo CRO a podmínkami této smlouvy, mimo jiné včetně platebních podmínek a rozpočtu, které jsou k této smlouvě připojeny jako příloha A, a veškerých dalších příloh této smlouvy. V případě rozporu mezi protokolem a touto smlouvou mají přednost podmínky protokolu, pokud jde o vědecké otázky související se studií. Ve všech ostatních případech mají přednost podmínky této smlouvy. Zdravotnické zařízení souhlasí s tím, že pokud zkoušející lékař nezařadí do rozhodného termínu pro nábor alespoň jeden (1) subjekt, smí CRO (na pokyn a z pověření zadavatele) tuto smlouvu ukončit v souladu s bodem 18.2 smlouvy. 5.2.1. In addition to the foregoing, Institution agrees that CRO may disclose any and all information and/or documents relating to this Agreement, and/or relating to Investigator’s and Institution’s participation in the Study (including without limitation any reports or other documents or materials provided by Investigator or Institution to CRO hereunder), to Sponsor. All references to Sponsor herein (whether in the context of delivery of information, submission of applications, financial terms, or anything else) derive from Sponsor’s sta...
Sample 1
Performance of the Study. The Study shall commence as soon as practicable after the Effective Date and shall be performed at various sites in the TDN and at various sites outside the TDN if it is deemed necessary by H-E, utilizing the TDN’s oversight services, in accordance with (i) the draft summary work plan developed and agreed to by the Parties (the “Work Plan”), * Confidential Treatment Requested as amended, from time to time, upon the mutual agreement of the Parties, and (ii) the details of the Study set forth in the Study Protocol.
Sample 1
Performance of the Study. Ichilov Tech shall procure the services of the Fund and/or the Hospital for the performance of the Study. Ichilov Tech shall procure that the technical, clinical and other resources reasonably required for the performance of the Study shall be dedicated to the performance of the Study. The term of the Study shall commence on the Effective Date ending as described in the Study Protocol, or as may be extended with the mutual written agreement of the Parties hereto. The Study shall be performed under the supervision of _____________________________, who shall serve as the Principal Investigator. In the event that the Principal Investigator is unable to continue conducting the Study, Ichilov Tech shall use its best efforts to appoint a successor investigator whose identity shall be jointly determined by the Parties. Ichilov Tech and the Company shall hold status meetings with the Principal Investigator starting on the Effective Date. In such meetings, the Parties shall review and discuss the progress of the Study, analyze the results, and discuss and attempt to resolve any problem in the Study and any feedback collected during the preceding time period.
Sample 1
Performance of the Study. Poskytovatel a hlavní zkoušející poskytnou služby spojené s provedením klinického hodnocení, uvedené v protokolu, který je součástí této smlouvy, a začleněné v této smlouvě (dále jen „služby“). Služby budou poskytovány v souladu s podmínkami této smlouvy, protokolem a všemi platnými zákony, pravidly a předpisy, avšak za předpokladu, že protokol byl schválen společností PPD, zadavatelem, Státním ústavem pro kontrolu léčiv (dále jen „regulační úřad” nebo „RU“), multi-centrickou etickou komisí (dále jen “MEK“) a příslušnou lokální etickou komisí („LEK“). Pokud existuje rozpor mezi podmínkami uvedenými v protokolu a v této smlouvě, pak jsou určující podmínky protokolu pro provádění klinického hodnocení a léčbu subjektů s ním související a podmínky smlouvy jsou určující pro ostatní záležitosti. Kopie souhlasných stanovisek RÚ, MEK a LEK tvoří Přílohu č. 4 této smlouvy. Institution and Principal Investigator shall provide those certain services related to the conduct of the Study and set forth in the Protocol, which Protocol is made a part of this Agreement and incorporated by reference herein (“Services”). The Services shall be provided in accordance with the terms of this Agreement, the Protocol, and all applicable laws, rules and regulations; provided, however that such Protocol has been approved by PPD, Sponsor, the State Institute for Drug Control (“Regulatory Authority” or “RA”), a Multi-centre Ethics Committee (“MEC”) and the appropriate Local Ethics Committee (“LEC”). If there is any discrepancy or conflict between the terms contained in the Protocol and this Agreement, the terms of the Protocol shall govern and control the conduct of the Study and the treatment of Subjects in connection therewith and the Agreement will govern and control all other matters. Copies of the concurring opinions of RA, MEC and LEC collectively form Exhibit 4 hereto.
Sample 1
Performance of the Study. The Study shall commence as soon as practicable after the Effective Date and shall be performed at various sites in the TDN and at various sites outside the TDN if it is deemed necessary by TG, utilizing the TDN’s oversight services, in accordance with (i) the draft summary work plan developed and agreed to by the Parties (the “Work Plan”), as amended, from time to time, upon the mutual agreement of the Parties, and (ii) the details of * Confidential treatment requested. the Study set forth in protocol number 25E01 entitled “A Multicenter, Double-Blind, Placebo Controlled, Phase II Study of Aerosolized tgAAVCF for the Treatment of Cystic Fibrosis”.
Sample 1

Related to Performance of the Study

  • Performance of the Services In addition to the Common Articles, it is specified that:

  • Performance of the Work The Contractor shall perform all of the Work required for the complete and prompt execution of everything described or shown in, or reasonably implied from the Contract Documents for the above referenced Project.

  • PERFORMANCE OF THE CONTRACT II.1.1. The Contractor shall perform the Contract to the highest professional standards. The Contractor shall have sole responsibility for complying with any legal obligations incumbent on him, notably those resulting from employment, tax and social legislation. II.1.2. The Contractor shall have sole responsibility for taking the necessary steps to obtain any permit or licence required for performance of the Contract under the laws and regulations in force at the place where the tasks assigned to him are to be executed. II.1.3. Without prejudice to Article II.3 any reference made to the Contractor’s staff in the Contract shall relate exclusively to individuals involved in the performance of the Contract. II.1.4. The Contractor must ensure that any staff performing the Contract have the professional qualifications and experience required for the execution of the tasks assigned to them. II.1.5. The Contractor shall neither represent the Agency nor behave in any way that would give such an impression. The Contractor shall inform third parties that he does not belong to the European public service. II.1.6. The Contractor shall have sole responsibility for the staff who execute the tasks assigned to him. II.1.7. In the event of disruption resulting from the action of a member of the Contractor's staff working on Agency premises or in the event of the expertise of a member of the Contractor's staff failing to correspond to the profile required by the Contract, the Contractor shall replace him without delay. The Agency shall have the right to request the replacement of any such member of staff, stating its reasons for so doing. Replacement staff must have the necessary qualifications and be capable of performing the Contract under the same contractual conditions. The Contractor shall be responsible for any delay in the execution of the tasks assigned to him resulting from the replacement of staff in accordance with this Article. II.1.8. Should any unforeseen event, action or omission directly or indirectly hamper execution of the tasks, either partially or totally, the Contractor shall immediately and on his own initiative record it and report it to the Agency. The report shall include a description of the problem and an indication of the date on which it started and of the remedial action taken by the Contractor to ensure full compliance with his obligations under the Contract. In such event the Contractor shall give priority to solving the problem rather than determining liability. II.1.9. Should the Contractor fail to perform his obligations under the Contract in accordance with the provisions laid down therein, the Agency may - without prejudice to its right to terminate the Contract - reduce or recover payments in proportion to the scale of the failure. In addition, the Agency may impose penalties or liquidated damages provided for in Article II.16.

  • Performance of Reviews The RIRs shall send a request for review to the Operator per email, where they shall specify the areas they request a review for. The Operator must comply with the request by providing the requested information within working days. The review may include an onsite inspection. In this case the RIRs and the Operator must agree on a specific date for the inspection to take place, which may not be later than sixty calendar days from the date of the request.

  • Performance of the Company The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by this Agreement and the Registration Rights Agreement to be performed, satisfied or complied with by the Company at or prior to the Commencement. The Company shall deliver to the Investor on the Commencement Date the compliance certificate substantially in the form attached hereto as Exhibit C (the “Compliance Certificate”).

  • Performance of Work a. Contractor shall perform all Work in a good and workmanlike manner. Contractor shall maintain sufficient staff and crews to perform all Work in an expeditious manner consistent with the interests of the Park District. Contractor shall promptly notify the Park District immediately in writing: (i) of any information required from the Park District and necessary for Contractor to complete its Work in a timely manner; and (ii) of any Work requested by the Park District or required for the project that is not included in the scope of Work reflected in the Contract Documents. Contractor shall be solely responsible for means and methods selected in performing the Work. Contractor shall supervise all Work so that it is performed in a safe and expeditious manner. Contractor shall be solely responsible for the Work of its employees and its subcontractors’ and suppliers’ employees. Contractor shall keep all documents and information related to the project confidential and, except as required by law, shall not disclose such documents or information to any person or other party except the employees of Contractor and its subcontractors who need such documents or information to perform the Work and complete the project. b. Contractor shall confine all equipment, the storage of materials and the operations of its workers, to limits indicated by law, ordinances, permits, or directions of the Park District and shall not unreasonably encumber the project site with such materials. The project site shall not be utilized for the storage of vehicles, materials, equipment, or fixtures not intended for the Work to be performed. c. Contractor shall notify all utility companies, public and private, as necessary in advance of commencing performance of the Work. The responsibility for moving water lines, gas lines, wire lines, service connections, water and gas meter boxes, water and gas valve boxes, light standards, cable ways, signals and all other utility appurtenances which are within the limits of the proposed construction will be assumed by the Contractor, at no additional compensation. The Contractor shall verify the location of all utilities prior to the start of construction and shall be responsible for the preservation of existing utility installation and the cost of providing precautionary supports, braces, or other equipment to insure against damage to said utility installation. The cost to repair and replace any new or existing utilities damaged will be paid for by the Contractor. d. If Contractor uncovers or discovers any concealed condition differing materially from conditions depicted in the Contract Documents or differing from conditions reasonably anticipated or inherent in the Work, Contractor shall immediately stop the Work and notify the Park District of the condition in writing. The Park District shall then issue written directions. Contractor shall not proceed with the Work until the Park District has issued written directions. The contract time and Contract Sum shall be equitably adjusted if necessitated by such directions of the Park District.

  • Performance of the Agreement 2.1 The Designer must make every effort to perform the work commissioned carefully and independently, to promote the client’s interests to the best of his or her ability and to aim to achieve a result that is useful to the client, as can and may be expected of a reasonably and professionally acting designer. To the extent necessary the Designer must keep the client informed of the progress of the work. 2.2 The client must do any and all things that are reasonably necessary or required to enable the Designer to deliver punctually and properly, such as supplying (or causing the supply of) complete, sound and clear data or materials in a timely manner of which the Designer states or of which the client understands or should reasonably understand that they are necessary for the performance of the agreement. 2.3 Terms stated by the Designer for the performance of the work commissioned are approximations only, unless otherwise agreed in writing. 2.4 Unless otherwise agreed, the following do not form part of the work commissioned to the Designer: a. performing tests, applying for permits and assessing whether the client’s instructions comply with statutory or quality standards; b. investigating any existing rights, including patents, trademarks, drawing or design rights or portrait rights of third parties; and c. investigating the possibility of the forms of protection referred to in (b) for the Client. 2.5 Prior to performance, production, reproduction or publication, the parties must give each other the opportunity to check and approve the final draft, prototypes or galley proofs of the result. 2.6 Differences between the (final) result and the agreements made cannot serve as grounds for rejection, discount, damages or dissolution of the agreement if those differences are reasonably of minor importance, taking all the circumstances into account. 2.7 Any complaints must be filed with the Designer in writing at the earliest possible time but no later than ten business days after completion of the work commissioned, failing which the client is deemed to have accepted the result of the work commissioned in its entirety.

  • Performance of Services The Contractor is responsible for fully meeting all obligations set forth in the Contract and for providing Product in accordance with the Contract or any Authorized User Agreement.

  • Performance of Work by City If the Contractor fails to perform the Work in accordance with the schedule referred to in section 2 above, the City may, in its discretion, in order to bring the project closer to the schedule, perform or cause to be performed some or all of the Work, and doing so shall not waive any of the City’s rights and remedies. Before doing so, the City shall give the Contractor notice of its intention. The Contractor shall reimburse the City for additional costs incurred by the City in exercising its right to perform or cause to be performed some or all of the Work pursuant to this section.

  • Development Program RWJPRI shall be [**] and have [**] in consultation with the JDAC, to select LICENSED COMPOUNDS which shall then be designated PRODUCTS for further DEVELOPMENT by RWJPRI and marketing by ORTHO and its AFFILIATES. RWJPRI shall provide KOSAN with written notice of its decision to select a LICENSED COMPOUND for DEVELOPMENT. Once a PRODUCT has been selected for further DEVELOPMENT, RWJPRI, with the advice of the JDAC, shall have the [**] right to develop the PRODUCT through STAGES O, I, II and III and shall have the [**] right to prepare and file, and shall be the owner of, all applications for MARKETING AUTHORIZATION throughout the world. During such DEVELOPMENT efforts, KOSAN will assist RWJPRI as may be mutually agreed, at RWJPRI's expense, in chemical development, formulation development, production of labeled material and production of sufficient quantities of material for STAGE O and initial STAGE I studies. RWJPRI shall exercise diligent efforts, commensurate with the efforts it would normally exercise for products with similar potential sales volume and consistent with its overall business strategy, in developing such PRODUCT in accordance with the DEVELOPMENT PLAN established by RWJPRI. In the course of such efforts RWJPRI shall, either directly or through an AFFILIATE or SUBLICENSEE to which the license shall have been extended, take appropriate steps including the following: (i) in consultation with the JDAC, select certain LICENSED COMPOUNDS for STAGE O DEVELOPMENT; and (ii) establish and maintain a program reasonably designed, funded and resourced to obtain information adequate to enable the preparation and filing with an appropriate and properly empowered national regulatory authority all necessary documentation, data and [**] CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. other evidence required for IND non-rejection to commence and conduct human clinical trials of such PRODUCT. (iii) proceed following IND non-rejection to commence PHASE I, II, and III clinical trials, associated studies and such other work which RWJPRI reasonably deems to be required for subsequent inclusion in filings for MARKETING AUTHORIZATION; (iv) after such submissions are filed prosecute such submissions and file all reasonably necessary, reports and respond to all reasonable requests from the pertinent regulatory, authorities for information, data, samples, tests and the like.

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