CROs Sample Clauses

CROs. (i) Subject to the terms and conditions of this Agreement, Dermira shall, in relation to the Development of the Product in the Development Indication in the Development Territory, have primary responsibility for selection and appointment of (i) the CROs that will manage any Phase 3 Study, or any Post-Approval Study in the Development Indication, (ii) the institutions at which a Phase 3 Study, and any Post-Approval Study in the Development Indication, will be performed (“Institutions”), and (iii) the principal investigator at each Institution designated to supervise the work of all persons who assist in performing a Phase 3 Study, or any Post-Approval Study in the Development Indication, at such Institution (each, an “Investigator”), including replacement Investigators. (ii) Dermira’s selection, removal and/or replacement of the CROs for the Phase 3 Study, and any Post-Approval Study in the Development Indication shall be subject to discussion at the JDT and the approval by the JDC and the JSC, if applicable, and as the case may be, as a Development Matter under Section 4.25, provided that Dermira may not remove and/or replace [*] CROs at any one time. (iii) The form of any agreement with either CRO entered into hereunder (a “CRO Agreement”) shall, in the case of a CRO Agreement to be entered into by or on behalf of Dermira, be subject to approval by UCB. Each CRO Agreement entered into by Dermira, as it may be amended from time to time, shall contain provisions that comply, or permit Dermira to comply (as applicable), with its obligations under this Section 5.10 and the Safety Agreement and that are otherwise consistent with this Agreement. Dermira shall provide a copy of each UCB approved fully-executed CRO Agreement entered into by Dermira and amendments thereto to the JDT promptly following the execution thereof, and shall ensure that no CRO shall commence any activities (other than preliminary feasibility work in order to provide a quote) with respect to any Phase 3 Study or any Post-Approval Study unless and until the JDC has received a fully-executed CRO Agreement. (iv) If either or both CROs is or are unable or unwilling to continue in such role, Dermira’s Contact shall promptly notify UCB’s Contact thereof, and Dermira shall use Commercially Reasonable Efforts to find a suitable replacement, subject to Section 5.10(a)(ii).
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CROs. Surrozen’s right to transfer possession of the Biological Materials and Identified Antibody(ies) and/or Derivative Antibody(ies) to third parties is expressly limited under the terms of this Agreement. Surrozen shall have the right to transfer the Biological Materials, Identified Antibody(ies) and/or Derivative Antibody(ies) solely to CROs for the express purpose of performing research in the Field of Use on behalf of Surrozen. If Surrozen transfers any Biological Materials, Identified Antibody(ies) and/or Derivative Antibody(ies) to CROs, it hereby agrees that such CROs shall be required to comply with the terms and conditions of this Agreement. For the purpose of this Agreement, Surrozen shall remain responsible for the performance of its rights and obligations set out in this Agreement by such recipient CROs, including the confidentiality and material handling protections set forth in this Agreement.
CROs. Any agreement(s) with a CRO for the conduct of a Clinical Trial in Japan shall be agreed upon and signed jointly by the CRO on the one side and by BMKK, in its own capacity and as agent for ImClone pursuant to Section 3.2(b) below, and MJ on the other, but only after consultation, review and approval of such CRO agreement by the SCJ; provided, that BMKK may also enter into a CRO agreement without MJ and without the consent of the other Parties, and vice-versa, (x) in order to perform Development obligations undertaken by MJ or BMKK under Section 3.1(c) or (y) if and to the extent needed to cure a breach of such other Party’s Development obligations under this Agreement. Further, except where a CRO is used, BMKK, in its own capacity and as agent for ImClone pursuant to Section 3.2(b) below, and MJ shall both sign all Clinical Trial agreements with each Clinical Trial site for studies conducted in Japan under the Annual Development Plan and Budget, unless agreed to otherwise by the JJDC or SCJ or unless and to the extent necessary in order to cure a breach of this Agreement by the other Party.
CROs. Apellis may delegate any of its responsibilities to its Affiliates (subject to Section 15.1) and/or one (1) or more CROs. CROs performing any material aspect of the Trial as of the Effective Date are listed in Exhibit B.
CROs. FibroGen China shall ensure any such Clinical Trials are conducted through a FibroGen China Affiliate incorporated in the Territory. In the event that FibroGen China engages a Third Party contract research organization (“CRO”) to undertake any Clinical Trial (or any portion of any Clinical Trial), FibroGen China shall ensure that such CRO is qualified in the Territory and capable of producing data acceptable to the CFDA and other applicable Regulatory Authorities in the Territory. FibroGen China shall discuss any possible engagement of a CRO with the China Committee. FibroGen China shall ensure that any Clinical Trials conducted in China shall be conducted only at hospitals that are accredited by the CFDA.

Related to CROs

  • Rosters 8.1 As far as practically possible, the Employer will draw up a roster 1 week in advance. Changes to rosters may occur with 24 hours notice or, subject to the availability of the Employee, with less notice if by mutual consent. 8.2 The Employer will ordinarily roster Employees in a manner that is both fair and equitable to ensure that, where applicable, the allocation of weekend and public holiday hours are equally divided between Employees on a rotating basis.

  • Chiropractic Services This plan covers chiropractic visits up to the benefit limit shown in the Summary of Medical Benefits. The benefit limit applies to any visit for the purposes of chiropractic treatment or diagnosis.

  • Third Party Vendors Nothing herein shall impose any duty upon DST in connection with or make DST liable for the actions or omissions to act of the following types of unaffiliated third parties: (a) courier and mail services including but not limited to Airborne Services, Federal Express, UPS and the U.S. Mails, (b) telecommunications companies including but not limited to AT&T, Sprint, MCI and other delivery, telecommunications and other such companies not under the party’s reasonable control, and (c) third parties not under the party’s reasonable control or subcontract relationship providing services to the financial industry generally, such as, by way of example and not limitation, the National Securities Clearing Corporation (processing and settlement services), Fund custodian banks (custody and fund accounting services) and administrators (blue sky and Fund administration services), and national database providers such as Choice Point, Acxiom, TransUnion or Lexis/Nexis and any replacements thereof or similar entities, provided, if DST selected such company, DST shall have exercised due care in selecting the same. Such third party vendors shall not be deemed, and are not, subcontractors for purposes of this Agreement.

  • Outreach Not less than 30 days prior to the opening of bids or the selection of contractors, the Agency-Assisted Contractor or Contractor shall:

  • Stewards Each UNION shall have the right to designate a working journeyman as a xxxxxxx. The UNION shall notify the EMPLOYER in writing of the identity of their designated xxxxxxx. In addition to his work as an employee, the xxxxxxx shall have the right to receive, but not to solicit, complaints or grievances, and to discuss and assist in the adjustment of the same with the employee's appropriate supervisor. The EMPLOYER will not discriminate against the xxxxxxx in the proper performance of his union duties. The xxxxxxx shall not leave his work area without first notifying his appropriate supervisor or xxxxxxx as to his intent and the reason thereof, he can be reached, and the estimated time that he will be gone. Stewards shall not have the right to determine when overtime shall be worked or who shall work overtime. The EMPLOYER shall have the right to implement a system of written accountability of time spent by all stewards in the performance of their duties whenever they deem such action necessary. The presence or absence of the xxxxxxx shall not affect the work of the craft. The xxxxxxx, in addition to this work as a journeyman, will be permitted to perform during the work hours such of his normal UNION duties as cannot be performed at other times. The UNION agrees that such duties shall be performed as expeditiously as possible and the EMPLOYER agrees to allow the xxxxxxx a reasonable amount of time to perform such duties. The xxxxxxx shall receive his regular craft rate of pay. The xxxxxxx'x duties shall not include any matters relating to any supervisory function over which the EMPLOYER retains sole control. If a xxxxxxx violates any of the rules of this Article, or fails to work or competently perform work assignments, the EMPLOYER shall have the right to take whatever action deemed appropriate, including termination. The working xxxxxxx designated for one EMPLOYER has no authority with regard to the work of another EMPLOYER. If he should become involved in the affairs or disputes of another EMPLOYER, he will be subject to discharge. The EMPLOYER agrees to notify the UNION two (2) working days, confirmed in writing stating the cause, prior to termination of the working xxxxxxx except for a violation of work rules. The xxxxxxx shall be the last EMPLOYEE laid off provided he is qualified to perform the remaining work of the EMPLOYER.

  • MIDDLE SCHOOLS 1. Where there are no negotiated provisions concerning the implementation or operation of a middle school program, this article shall govern the implementation or operation of a middle school program in a school district. 2. Should the employer seek to establish a middle school program in one or more schools in a district, the employer and the local shall meet, no later than ten (10) working days from a decision of the employer to implement a middle school program, in order to negotiate any alternate or additional provisions to the Collective Agreement which are necessary to accommodate the intended middle school program. 3. In the absence of any other agreement with respect to the instructional day and preparation time, the provisions of the Collective Agreement with regard to secondary schools shall apply to middle schools. 4. If the employer and the local are unable to agree on what, if any, alternate or additional provisions of the collective agreement are necessary to accommodate the intended middle school program(s), either party may refer the matter(s) in dispute to expedited arbitration for final and binding resolution pursuant to Article D.5.5 below. a. The jurisdiction of the arbitrator shall be limited to the determination of alternate or additional provisions necessary to accommodate the intended middle school program(s). b. In the event the arbitration is not concluded prior to the implementation of the middle school program, the arbitrator will have remedial authority to make appropriate retroactive modifications and adjustments to the agreement. c. The arbitration shall convene within thirty (30) working days of referral to arbitration in accordance with the following: i. Within ten (10) working days of the matter being referred to arbitration, the parties shall identify all issues in dispute; ii. Within a further five (5) working days, there shall be a complete disclosure of particulars and documents; iii. Within a further five (5) working days, the parties shall exchange initial written submissions; iv. The hearing shall commence within a further ten (10) working days; and v. The arbitrator shall render a final and binding decision within fifteen (15) working days of the arbitration concluding. 6. Where a middle school program has been established on or prior to ratification of the 2006-2011 Provincial Collective Agreement, the existing provisions shall be retained unless the parties mutually agree that they should be amended.

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  • Roster It is understood that the Industry Troubleshooters named below (or substitutes agreed to by the parties) shall be appointed on a rotating basis commencing with the first Troubleshooter named: Xxxx Xxxxxxxx Xxxxx Xxxxxx Xxxxxx Xxxxx Xxxx Xxxxxx Xxxxx Xxxxxxx Xxxxx X. Ready Xxxxx Xxxxxxxx In the event the parties are unable to agree on an Industry Troubleshooter within a period of thirty

  • Scholarships Fellowships.

  • Hospital This plan covers behavioral health services if you are inpatient at a general or specialty hospital. See Inpatient Services in Section 3 for additional information. This plan covers services at behavioral health residential treatment facilities, which provide: • clinical treatment; • medication evaluation management; and • 24-hour on site availability of health professional staff, as required by licensing regulations. This plan covers intermediate care services, which are facility-based programs that are: • more intensive than traditional outpatient services; • less intensive than 24-hour inpatient hospital or residential treatment facility services; and • used as a step down from a higher level of care; or • used a step-up from standard care level of care. Intermediate care services include the following: • Partial Hospital Program (PHP) – PHPs are structured and medically supervised day, evening, or nighttime treatment programs providing individualized treatment plans. A PHP typically runs for five hours a day, five days per week. • Intensive Outpatient Program (IOP) – An IOP provides substantial clinical support for patients who are either in transition from a higher level of care or at risk for admission to a higher level of care. An IOP typically runs for three hours per day, three days per week.

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