Approval Support Sample Clauses

Approval Support. Impax shall produce stability batches and validation batches, engage in various development activities and perform various tests as necessary for receipt of the Health Registrations in the Territory, including without limitation, being prepared for the pre-approval inspections by the Regulatory Authorities and performing the other activities set forth in Exhibit 7.1 hereto.
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Approval Support. The project team will support the plan approval process by attending virtual and in-person meetings with local and/or regional commissions, committees, or other elected bodies. To support these meetings, the project team will also develop clear and concise PowerPoint presentations that summarize key aspects of the plan and the work completed to date. As needed, we will also provide supporting analysis, documentation, exhibits, and materials for other presentations and stakeholder conversations to be conducted by City and County staff.
Approval Support. NTC shall produce stability batches, engage in various development activities and perform various tests as are necessary for compliance with the United States Pharmacopeia (USP) in the Territory and to be prepared for the pre-approval inspections by the Regulatory Authorities and perform other activities as may be applicable.

Related to Approval Support

  • Technical Support State Street will provide technical support to assist the Fund in using the System and the Data Access Services. The total amount of technical support provided by State Street shall not exceed 10 resource days per year. State Street shall provide such additional technical support as is expressly set forth in the fee schedule in effect from time to time between the parties (the “Fee Schedule”). Technical support, including during installation and testing, is subject to the fees and other terms set forth in the Fee Schedule.

  • Operational Support 2.1 Party A agrees, according to the operational needs of Party B, to act as the guarantor of Party B in the contracts, agreements, or transactions entered into between Party B and third parties, in order to fully guarantee the performance by Party B of such contracts, agreements, and transactions. 2.2 Party A agrees, according to the operational needs Party B, to recommend directors and senior management to Party B and Party B agrees to appoint such personnel recommended by Party A to be its directors and senior management. The relevant personnel recommended by Party A pursuant to this Article shall meet the qualification requirements for directors and senior management under applicable laws. 2.3 To ensure the performance of this Agreement, Party A agrees to provide to Party B cooperative policy advice and guidance, which is consistent with the daily operation and financial management and the employment policy of Party B.

  • Additional Support Under this Agreement, there shall be: (check one)

  • FINANCIAL SUPPORT 3.1 The individual support from Erasmus+ EU funds for the mobility period is EUR […], corresponding to EUR […] per month and EUR […] per extra days. The final amount of Erasmus+ EU funds for the mobility period shall be determined by multiplying the number of months of the mobility covered by Erasmus+ EU funds specified in article 2.4 with the rate applicable per month for the receiving country concerned. In the case of incomplete months, the financial support from Erasmus+ EU funds is calculated by multiplying the number of days in the incomplete month with 1/30 of the unit cost per month. [Institution to select if applicable and complete with specific rules if needed: The financial support other than Erasmus+ EU funds for the mobility period is EUR […].] 3.2 [NA/institution shall select Option 1 or Option 2] [Option 1: [In addition, the participant shall receive […] EUR as a contribution for travel.] [For zero-grant participants, the contribution for travel should be 0] [Option 2: [In addition, the institution shall provide the participant with travel support in the form of direct provision of the required travel support services. In such case, the institution shall ensure that the provision of services will meet the necessary quality and safety standards.] 3.3 The reimbursement of costs incurred in connection with special needs, when applicable, shall be based on the supporting documents provided by the participant. 3.4 The financial support may not be used to cover similar costs already funded by EU funds. 3.5 Notwithstanding article 3.4, the grant is compatible with any other source of funding including revenue that the participant could receive working beyond his/her studies/traineeship as long as he/she carries out the activities foreseen in Annex I. 3.6 The financial support or part thereof shall be repaid if the participant does not carry out the mobility activity in compliance with the terms of the agreement [NA to complete with specific recovery rules if needed]. If the participant terminates the agreement before it ends, he/she shall have to refund the amount of the grant already paid, except if agreed differently with the institution. However, when the participant has been prevented from completing his/her mobility activities as described in Annex I due to force majeure, he/she shall be entitled to receive at least the amount of the grant corresponding to the actual duration of the mobility period. Any remaining funds shall have to be refunded, except if agreed differently with the institution. Such cases shall be reported by the institution and accepted by the National Agency.

  • Operational Support Systems (OSS The terms, conditions and rates for OSS are as set forth in Section 2.13 of this Attachment.

  • Operational Support Systems <<customer_name>> shall pay charges for Operational Support Systems (OSS) as set forth in this Agreement in Attachment 1 and/or in Attachments 2, 3 and 5, as applicable.

  • Child Support (Applicable if the Party is a natural person, not a corporation or partnership.) Party states that, as of the date the Agreement is signed, he/she: a. is not under any obligation to pay child support; or b. is under such an obligation and is in good standing with respect to that obligation; or c. has agreed to a payment plan with the Vermont Office of Child Support Services and is in full compliance with that plan. Party makes this statement with regard to support owed to any and all children residing in Vermont. In addition, if the Party is a resident of Vermont, Party makes this statement with regard to support owed to any and all children residing in any other state or territory of the United States.

  • Technical Support Services 2.1 The technical support services (the "Services"): Party A agrees to provide to Party B the relevant services requested by Party B, which are specified in Exhibit 1 attached hereto ("Exhibit 1").

  • Training and Support Licensor shall offer installation support to the Licensee and each of the Members, including assisting with the implementation of any Licensor software. Licensor will provide appropriate training to Licensee and Member staff relating to the use of the Licensed Materials and any Licensor software. Licensor will offer reasonable levels of continuing support to assist Licensee and Members in use of the Licensed Materials, including providing help files and other appropriate user documentation in connection with the use of and access to Licensed Materials. Licensor will, at a minimum, make its personnel available by email, telephone or via the Web, or in person during Licensor’s regular business hours, Monday through Friday, for training and user access support.

  • Clinical Supply In connection with the Technology Transfer, Lexicon shall transfer to Sanofi any usable inventory of Licensed Compound or Licensed Product, subject to Lexicon’s retention of reasonable requirements of such Licensed Compound or Licensed Product for its T1DM Development activities no later than [**] (or such other date as is agreed by the Parties), and Lexicon’s Manufacturing Cost paid to Lexicon CMOs for such transferred quantities of inventory shall be treated as Development Costs and borne by the Parties in accordance with Section 7.6. Prior to the completion of the Technology Transfer in accordance with Section 6.2, Lexicon shall, to the extent requested by Sanofi and as mutually agreed by the Parties, supply clinical quantities of the Licensed Products and placebo for use by Sanofi in the Development of Licensed Products for T2DM in accordance with the Development Plan, and Lexicon’s Manufacturing Cost incurred in connection therewith shall be treated as Development Costs. After the Technology Transfer, Sanofi shall supply clinical quantities of the Licensed Products and placebo reasonably required by Lexicon for Lexicon’s use in the Development of Licensed Products for T1DM in accordance with the Development Plan and for its own use in the Development of Licensed Products. Lexicon shall Manufacture (or have Manufactured) all such Licensed Product in accordance with Applicable Law and the applicable specifications therefor, including, to the extent required by Applicable Law, cGMP; provided that Lexicon’s liability arising from a breach by the CMO of its agreement with Lexicon shall be limited to such recoveries as are obtained by Lexicon using Commercially Reasonable Efforts to obtain such recoveries and such other remedies as may be available to Lexicon for such breach under its agreement with such CMO. Otherwise, Sanofi’s sole and exclusive remedy and Lexicon’s sole and exclusive liability to Sanofi for any nonconformity shall be for Lexicon to replace such nonconforming Licensed Compound or Licensed Product with conforming Licensed Compound or Licensed Product within reasonable timelines to be mutually agreed by the Parties in writing, but nothing in this Section 6.1.1 shall limit Lexicon’s liability for Third Party Claims under ARTICLE 11. At either Party’s option, Lexicon and Sanofi shall enter into a clinical supply agreement and a reasonable and customary Quality Agreement that shall set forth the terms and conditions upon which Lexicon and any of its Affiliates will conduct their quality activities in connection with such supply, including (i) a right of Sanofi to audit Lexicon and the Lexicon CMOs, (ii) coordination regarding inspections by Regulatory Authorities and (iii) the exchange of information between the Parties regarding the foregoing and quality issues in general. Such agreements shall be negotiated and agreed by the Parties in good faith.

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