IRBs and Other Ethics Committees Sample Clauses

IRBs and Other Ethics Committees. CRO will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Project at every Site. CRO will require that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law and CRO will provide all ethics committees, including all IRBs, and regulatory authorities, with all necessary documentation prior to, and during the course of, the Project as required by Applicable Law. CRO will be solely responsible for responding to all queries from the IRBs and other ethics committees; provided that (a) Sponsor will make itself reasonably available to assist with any such queries and (b) if such query relates solely to the CMC information, the manufacturing dossier, Sponsor will prepare the applicable response, with a copy to be provided to CRO.
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IRBs and Other Ethics Committees. 4.9.1. OPKO will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Trial at every Site. 4.9.2. OPKO will ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law, and OPKO will provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, each Trial as required by Applicable Law. 4.9.3. From and after the Effective Date, OPKO will be solely responsible for responding to all queries from the IRBs and other ethics committees; provided that (a) Pfizer *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. will make itself reasonably available to assist with any such queries, and (b) if such query relates solely to the CMC Information, Pfizer will prepare the applicable response and provide OPKO with a copy thereof. 4.9.4. The ultimate responsibility for fulfillment of all pharmacovigilance obligations resides with the IND or CTA holder and/or the marketing authorization holder according to relevant Applicable Laws.
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IRBs and Other Ethics Committees. Opthea will use Commercially Reasonable Efforts to (a) obtain the approval of the IRBs and other ethics committees required prior to commencing, and during, the Product Clinical Trials at every Site, (b) ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law, (c) provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Product Clinical Trials as required by Applicable Law, and (d) respond to all queries from the IRBs and other ethics committees, will prepare the applicable response and, if such query is material, will provide Investor with a copy thereof for review and comment reasonably prior to submission.
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IRBs and Other Ethics Committees. CymaBay will use Commercially Reasonable Efforts to (a) obtain the approval of the IRBs and other ethics committees required prior to commencing, and during, the Product Clinical Trials at every Site, and (b) ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law. CymaBay will (a) provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Product Clinical Trials as required by Applicable Law, and (b) respond to all queries from the IRBs and other ethics committees, will prepare the applicable response.
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IRBs and Other Ethics Committees. 3.8.1 Each Party will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Clinical Trials at every Site in such Party’s Territory, except in the case of the European Clinical Trial Countries which SFJ will be responsible for. 3.8.2 Each Party will ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law and will provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Clinical Trials as required by Applicable Law. 3.8.3 PB in the US, and SFJ in the SFJ Territory and in the European Clinical Trial Countries, will be responsible for responding to all queries from the IRBs and other ethics committees; provided that (a) the other Party will make itself reasonably available to assist with any such queries and (b) if such query relates solely to the CMC Information, the Manufacturing Dossier, and/or preclinical studies, PB will prepare the applicable response and provide SFJ with a copy thereof.
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IRBs and Other Ethics Committees. 4.9.1. OPKO will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Trial *** at every Site. 4.9.2. OPKO will ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law, and OPKO will provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, each Trial *** as required by Applicable Law. 4.9.3. From and after the Original Effective Date, OPKO will be solely responsible for responding to all queries from the IRBs and other ethics committees ***; provided that (a) Pfizer will make itself reasonably available to assist with any such queries, and (b) if such query relates solely to the CMC Information, Pfizer will prepare the applicable response and provide OPKO with a copy thereof. 4.9.4. The ultimate responsibility for fulfillment of all pharmacovigilance obligations resides with the IND or CTA holder and/or the marketing authorization holder according to relevant Applicable Laws.
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IRBs and Other Ethics Committees. Alnylam will be solely responsible for (a) obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the Product Clinical Trials at every Site, and responding to all queries from all IRBs and other ethics committees, (b) ensuring that IRBs and such other relevant ethics committees have current registrations and accreditations, and (c) providing all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the Product Clinical Trials.
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IRBs and Other Ethics Committees. 3.8.1 SFJ will be responsible for obtaining the approval of the IRBs and other ethics committees required prior to commencing, and during, the HNC Clinical Trials at every Site. 3.8.2 SFJ will ensure that IRBs and such other relevant ethics committees have current registrations and accreditations as required by Applicable Law and will provide all ethics committees, including all IRBs, and Regulatory Authorities, with all necessary documentation prior to, and during the course of, the HNC Clinical Trials as required by Applicable Law. 3.8.3 SFJ will be responsible for responding to all queries from the IRBs and other ethics committees; provided that (a) Nektar will make itself reasonably available to assist with any such queries and (b) if such query relates solely to the CMC Information, the Manufacturing Dossier, and/or preclinical studies, Nektar will prepare the applicable response and provide SFJ with a copy thereof.
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Related to IRBs and Other Ethics Committees

  • Executive and Other Committees The Trustees by vote of a majority of all the Trustees may elect from their own number an Executive Committee to consist of not less than two members to hold office at the pleasure of the Trustees, which shall have the power to conduct the current and ordinary business of the Trust while the Trustees are not in session, including the purchase and sale of securities and the designation of securities to be delivered upon redemption of Shares of the Trust or a Series thereof, and such other powers of the Trustees as the Trustees may delegate to them, from time to time, except those powers which by law, the Declaration of Trust or these By-Laws they are prohibited from delegating. The Trustees may also elect from their own number other Committees from time to time; the number composing such Committees, the powers conferred upon the same (subject to the same limitations as with respect to the Executive Committee) and the term of membership on such Committees to be determined by the Trustees. The Trustees may designate a Chairman of any such Committee. In the absence of such designation the Committee may elect its own Chairman.

  • Consultant’s Contract Manager and Other Staffing Identified below are the following: (a) the Consultant’s contract manager for this Approved Service Order, and (b) the Consultant(s) and/or employee(s) of the Consultant who will be principally responsible for providing the services and deliverables. If an individual identified below does not have a current Form 700 on file with the City Clerk for a separate agreement with the City, and is required to file a Form 700, the Consultant must comply with the requirements of Subsection 17.2 of the Master Agreement, entitled “Filing Form 700.”

  • Labor and Other Employment Matters (a) (i) Neither the Parent nor any of the Parent Subsidiaries is a party to or bound by any collective bargaining or similar agreement or work rules or practices with any labor union, works council, labor organization or employee association applicable to employees of the Parent or any Parent Subsidiary, nor are there any negotiations or discussions currently pending between the Parent or the Parent Subsidiaries and any union, work counsel, labor organization, or employee association, (ii) there have been no strikes, work stoppages, shutdowns, or lockouts with respect to any Parent Employee during the last five (5) years, (iii) to the knowledge of the Parent, there is no effort pending or threatened against the Parent or any Parent Subsidiary, (iv) there is no unfair labor practice, labor dispute (other than routine individual grievances) or labor arbitration proceeding pending or, to the knowledge of the Parent, threatened with respect to Parent Employees, and (v) there is no slowdown, work stoppage or similar labor activity in effect or, to the knowledge of the Parent, threatened with respect to Parent Employees; except, with respect to clauses (ii) through (v) hereof, as would not have, or would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. (b) The Parent and the Parent Subsidiaries are, and have been, in compliance in all material respects with all applicable Laws respecting (i) employment and employment practices, (ii) terms and conditions of employment and wages and hours, including the obligations of the WARN Act, (iii) unfair labor practices, and (iv) occupational safety and health and immigration, except as set forth in Section 5.12(b) of the Parent Disclosure Letter, neither Parent nor any Parent Subsidiary has implemented, conducted or experienced a “plant closing” or “mass layoff” as defined in the WARN Act (or any similar group personnel action requiring advance notice under the WARN Act) affecting any site of employment or one or more facilities or operating units within any site of employment or facility of Parent or any Parent Subsidiary. (c) Except as set forth in Section 5.12(c) of the Parent Disclosure Letter, there are no proceedings pending or, to the knowledge of the Parent, threatened against the Parent or any of the Parent Subsidiaries in any forum by or on behalf of any present or former Parent Employee or any present or former employee of any Person providing services to any Parent Entity for which Parent could reasonably be expected to be liable that, individually or in the aggregate, would reasonably be expected to have a Parent Material Adverse Effect, any applicant for employment or classes of the foregoing alleging unpaid or overdue wages or compensation due, breach of any express or implied employment contract, violation of any Law or regulation governing employment or the termination thereof, or any other discriminatory, wrongful or tortious conduct on the part of the Parent of any of the Parent Subsidiaries in connection with the employment relationship that, individually or in the aggregate, would reasonably be expected to have a Parent Material Adverse Effect. (d) Each individual who renders service to the Parent or any Parent Subsidiary who is classified by the Parent or such Parent Subsidiary, as applicable, as having the status of an independent contractor or other non-employee status for any purpose (including for purposes of taxation and tax reporting and under any Parent Employee Benefit Plans) is properly so classified and treated in accordance with applicable Laws and for purposes of all Parent Employee Benefit Plans and perquisites.

  • COMPENSATION AND OTHER FEES As compensation for the services provided by Xxxxxx xxxxxxxxx, the Company agrees to pay to Xxxxxx: (A) The fees set forth below with respect to the Placement: 1. A cash fee payable immediately upon the closing of the Placement and equal to 6% of the aggregate gross proceeds raised in the Placement. Additionally, a cash fee payable within 48 hours of (but only in the event of) the receipt by the Company within 12 months of the Closing Date of any proceeds from the exercise of the Warrants sold in the Placement that are solicited by the Placement Agent and otherwise in compliance with Financial Industry Regulatory Authority (“FINRA”) Rule 5110 equal to 5% of the aggregate cash exercise price received by the Company upon such exercise, if any (the “Warrant Solicitation Fee”), provided, however, the Warrant Solicitation Fee shall be reduced (before any reduction to the Xxxxxx Warrants described in the last sentence of Section A.2 below or any reduction to the expense reimbursement to Xxxxxx in Section B below) to the extent (and only to the extent) that Xxxxxx’x aggregate compensation for the Placement, as determined under FINRA Rule 5110, would otherwise exceed 8%. Such determination of the actual Warrant Solicitation Fee shall be made promptly following completion of the Placement and communicated in writing to the Company. 2. Such number of warrants (the “Xxxxxx Warrants”) to be issued to Xxxxxx or its designees at the Closing to purchase shares of Common Stock equal to 5% of the aggregate number of Shares sold in the Placement. The Xxxxxx Warrants shall have the same terms as the Warrants (if any) issued to the Purchasers in the Placement except that the exercise price shall be at least 125% of the public offering price per share, but in any event not less than the Warrant exercise price, and the expiration date shall be November 27, 2012. The Xxxxxx Warrants shall not have antidilution protections or be transferable for six months from the date of the Offering except as permitted by FINRA Rule 5110, and further, the number of Shares underlying the Xxxxxx Warrants shall be reduced if necessary to comply with FINRA rules or regulations. Such determination of the actual number of Shares underlying the Xxxxxx Warrants shall be made promptly following completion of the Placement and communicated in writing to the Company. (B) The Company also agrees to reimburse Xxxxxx’x expenses (with supporting invoices/receipts) up to a maximum of 0.8% of the aggregate gross proceeds raised in the placement, but in no event more than $30,000 and only in the event the Placement has been consummated. If payable, such reimbursement shall be paid immediately upon the closing of the Placement.

  • Reports and Other Communications to Fund Shareholders The Manager shall assist in developing all general shareholder communications, including regular shareholder reports.

  • Compensation and Other Benefits Subject to the provisions of this Agreement, the Company shall pay and provide the following compensation and other benefits to the Executive during the Term as compensation for services rendered hereunder:

  • ACCOUNTING AND OTHER TERMS Accounting terms not defined in this Agreement shall be construed following GAAP. Calculations and determinations must be made following GAAP. Capitalized terms not otherwise defined in this Agreement shall have the meanings set forth in Section 13. All other terms contained in this Agreement, unless otherwise indicated, shall have the meaning provided by the Code to the extent such terms are defined therein.

  • Field Examination and Other Fees Subject to any limitations set forth in Section 5.7(c), Borrowers shall pay to Agent, field examination, appraisal, and valuation fees and charges, as and when incurred or chargeable, as follows (i) a fee of $1,000 per day, per examiner, plus out-of-pocket expenses (including travel, meals, and lodging) for each field examination of any Loan Party or its Subsidiaries performed by or on behalf of Agent, and (ii) the fees, charges or expenses paid or incurred by Agent if it elects to employ the services of one or more third Persons to appraise the Collateral, or any portion thereof.

  • Salary and Other Compensation As compensation for the services to be rendered by the Employee to the Company pursuant to this Agreement, the Employee shall be paid the following compensation and other benefits:

  • Utilities and Other Services 4.4.1 The Tenant shall arrange, at its own cost and expense, for the installation, connection and supply of all utilities and any other services required by it at or in relation to the Premises. 4.4.2 The Tenant shall pay to the suppliers, and indemnify the Landlord against, all charges for the installation, connection and supply of all utilities and any other services consumed or used at or in relation to the Premises and the Tenant shall comply with the requirements and regulations of the respective suppliers. Tenant to initial 4.4.3 For the purposes of this Clause 4.4, the term “utilities” shall include water, electricity, telecommunications network, gas and any water-borne sewerage systems.

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