Development and validation of Test Sample Clauses

Development and validation of Test. Methods shall be in compliance with GMPs, and should follow USP and ICH guidelines wherever possible. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
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Related to Development and validation of Test

  • DEVELOPMENT OR ASSISTANCE IN DEVELOPMENT OF SPECIFICATIONS REQUIREMENTS/ STATEMENTS OF WORK

  • Inspections and Tests 26.1 The Supplier shall at its own expense and at no cost to the Procuring Entity carry out all such tests and/or inspections of the Goods and Related Services as are specified in the SCC. 26.2 The inspections and tests may be conducted on the premises of the Supplier or its Subcontractor, at point of delivery, and/or at the Goods' final destination, or in another place in Kenya as specified in the SCC. Subject to GCC Sub-Clause 26.3, if conducted on the premises of the Supplier or its Subcontractor, all reasonable facilities and assistance, including access to drawings and production data, shall be furnished to the inspectors at no charge to the Procuring Entity. 26.3 The Procuring Entity or its designated representative shall be entitled to attend the tests and/or inspections referred to in GCC Sub-Clause 26.2, provided that the Procuring Entity bear all of its own costs and expenses incurred in connection with such attendance including, but not limited to, all travelling and board and lodging expenses. 26.4 Whenever the Supplier is ready to carry out any such test and inspection, it shall give a reasonable advance notice, including the place and time, to the Procuring Entity. The Supplier shall obtain from any relevant third party or manufacturer any necessary permission or consent to enable the Procuring Entity or its designated representative to attend the test and/or inspection. 26.5 The Procuring Entity may require the Supplier to carry out any test and/or inspection not required by the Contract but deemed necessary to verify that the characteristics and performance of the Goods comply with the technical specifications codes and standards under the Contract, provided that the Supplier's reasonable costs and expenses incurred in the carrying out of such test and/or inspection shall be added to the Contract Price. Further, if such test and/or inspection impedes the progress of manufacturing and/or the Supplier's performance of its other obligations under the Contract, due allowance will be made in respect of the Delivery Dates and Completion Dates and the other obligations so affected. 26.6 The Supplier shall provide the Procuring Entity with a report of the results of any such test and/or inspection. 26.7 The Procuring Entity may reject any Goods or any part thereof that fail to pass any test and/or inspection or do not conform to the specifications. The Supplier shall either rectify or replace such rejected Goods or parts thereof or make alterations necessary to meet the specifications at no cost to the Procuring Entity, and shall repeat the test and/or inspection, at no cost to the Procuring Entity, upon giving a notice pursuant to GCC Sub- Clause 26.4. 26.8 The Supplier agrees that neither the execution of a test and/or inspection of the Goods or any part thereof, nor the attendance by the Procuring Entity or its representative, nor the issue of any report pursuant to GCC Sub-Clause 26.6, shall release the Supplier from any warranties or other obligations under the Contract.

  • Commencement and Completion of Construction Subject to Unavoidable Delays, Developer shall cause construction of the Minimum Improvements to be undertaken and completed: (i) by no later than June 1, 2020; or (ii) by such other date as the parties shall mutually agree upon in writing. Time lost as a result of Unavoidable Delays shall be added to extend this date by a number of days equal to the number of days lost as a result of Unavoidable Delays. All work with respect to the Minimum Improvements shall be in conformity with the Construction Plans approved by the building official or any amendments thereto as may be approved by the building official. Developer agrees that it shall permit designated representatives of the City, upon reasonable notice (which does not have to be written), to enter upon the Development Property during the construction of the Minimum Improvements to inspect such construction and the progress thereof.

  • COMMENCEMENT AND COMPLETION OF THE PROJECT Section 3.01 The Project (a) The Company intends and expects, together with any Sponsor Affiliate, to (i) construct and acquire the Project, and (ii) meet the Contract Minimum Investment Requirement within the Investment Period. The Company anticipates that the first Phase of the Project will be placed in service during the calendar year ending December 31, 2020. (b) Pursuant to the FILOT Act and subject to Section 4.03 hereof, the Company and the County hereby agree that the Company and any Sponsor Affiliates shall identify annually those assets which are eligible for FILOT payments under the FILOT Act and which the Company or any Sponsor Affiliate selects for such treatment by listing such assets in its annual PT-300S form (or comparable form) to be filed with the Department (as such may be amended from time to time) and that by listing such assets, such assets shall automatically become Economic Development Property and therefore be exempt from all ad valorem taxation during the Exemption Period. Anything contained in this Fee Agreement to the contrary notwithstanding, the Company and any Sponsor Affiliates shall not be obligated to complete the acquisition of the Project. However, if the Company, together with any Sponsor Affiliates, does not meet the Contract Minimum Investment Requirement within the Investment Period, the provisions of Section 4.03 hereof shall control. (c) The Company may add to the Land such real property, located in the same taxing District in the County as the original Land, as the Company, in its discretion, deems useful or desirable. In such event, the Company, at its expense, shall deliver an appropriately revised Exhibit A to this Fee Agreement, in form reasonably acceptable to the County.

  • Inspection and Tests 3.8.1 The Procuring entity or its representative shall have the right to inspect and/or to test the goods to confirm their conformity to the Contract specifications. The Procuring entity shall notify the tenderer in writing in a timely manner, of the identity of any representatives retained for these purposes. 3.8.2 The inspections and tests may be conducted in the premises of the tenderer or its subcontractor(s), at point of delivery, and/or at the Goods’ final destination If conducted on the premises of the tenderer or its subcontractor(s), all reasonable facilities and assistance, including access to drawings and production data, shall be furnished to the inspectors at no charge to the Procuring entity. 3.8.3 Should any inspected or tested goods fail to conform to the Specifications, the Procuring entity may reject the equipment, and the tenderer shall either replace the rejected equipment or make alterations necessary to make specification requirements free of costs to the Procuring entity. 3.8.4 The Procuring entity’s right to inspect, test and where necessary, reject the goods after the Goods’ arrival shall in no way be limited or waived by reason of the equipment having previously been inspected, tested and passed by the Procuring entity or its representative prior to the equipment delivery. 3.8.5 Nothing in paragraph 3.8 shall in any way release the tenderer from any warranty or other obligations under this Contract.

  • Inspection and Testing Each Constructing Entity shall cause inspection and testing of the Interconnection Facilities that it constructs in accordance with the provisions of this section. The Construction Parties acknowledge and agree that inspection and testing of facilities may be undertaken as facilities are completed and need not await completion of all of the facilities that a Constructing Entity is building.

  • Access to Work District representatives shall at all times have access to the Work, wherever it is, in preparation or in progress. Contractor shall provide safe and proper facilities for such access.

  • Scope of Collaboration As part of the collaboration, the Controllers will act as Joint Controller. The roles of the Controller and the associated tasks are specified in more detail in Appendix 1. If one party is solely responsible for a data processing operation, this party will implement all relevant data protection provisions on its own responsibility. However, such data processing procedures are not subject to this Agreement. Joint data processing and the type of Personal Data collected and processed within the framework of collaboration are specified in Appendix 1.

  • Construction Phase - Administration of the Construction Contract INDICATE IN STATEMENT OF WORK “NOT APPLICABLE” IF SECTION IS NOT APPLICABLE 1.1.9.1. The Construction Phase will commence with the award of the Construction Contract to a selected vendor (“Contractor”) and will terminate when final payment is made by the State to the Contractor. In any event, the construction phase will not extend 60 days beyond the substantial completion date unless extended by change order. If such extension occurs, additional costs due to the ARCHITECT/ENGINEER shall be negotiated with the State. 1.1.9.2. The ARCHITECT/ENGINEER shall work with the State during the construction of the Project to provide the administration of the contract between the State and the Contractor in accordance with the terms herein and consistent with the contract between the State and the Contractor, and the extent of his/her duties and responsibilities and the limitations of his/her authority as assigned therein shall not be modified without his/her written consent. 1.1.9.3. The ARCHITECT/ENGINEER shall advise and consult with the State, and all of the State's instructions to the Contractor shall be issued through the ARCHITECT/ENGINEER after authorization by the State. 1.1.9.4. The ARCHITECT/ENGINEER shall, at all times, have access to the work wherever it is in preparation or progress. 1.1.9.5. The ARCHITECT/ENGINEER shall make periodic visits to the Project site, at least biweekly, and shall make such further visits when reasonably requested by the State, as to familiarize himself/herself with the progress and quality of the work performed and as to determine, on the basis of such visits, if such progress and quality are in accordance with the Contract Documents. The ARCHITECT/ENGINEER shall be responsible for project meeting minutes. In addition to this, the ARCHITECT/ENGINEER shall periodically report his/her findings thereon to the State, at such times as in the exercise of his/her professional judgment such findings are appropriate and at least monthly, at the conference provided for in Section 1.1.9.6, and further at such times as the State may reasonably request. The ARCHITECT/ENGINEER shall not be required to make exhaustive or continuous on-site inspections, except as required in the exercise of his/her professional judgment for said reports and, except in particular, to fulfill the commissioning requirements. The ARCHITECT/ENGINEER shall not be responsible for construction means, methods, techniques, sequences or procedures or for safety precautions and programs in connection with the work, and he/she shall not be responsible for the Contractor's failure to carry out the work in accordance with the Contract Documents except as provided for herein specifically between the State and the ARCHITECT/ENGINEER. 1.1.9.6. In preparing the bid documents, to the extent that the ARCHITECT/ENGINEER utilizes sub- consultants for their expertise, such as, but not limited to: Landscape Architects, Civil, Structural, Mechanical, and Electrical Engineers, these consultants, in effect, become an extension of the ARCHITECT/ENGINEER. Where the term ARCHITECT/ENGINEER is used in Section 1.1.9.2 as well as 1.1.9.5, it shall include those sub-consultants when work is being performed in their area of expertise. For example, the Mechanical Engineer would inspect the under slab plumbing before it is backfilled, but then wouldn’t necessarily be needed on site until the rest of the mechanical systems are being installed. The sub-consultant shall also be required to periodically inspect the progress of the “As-builts” and verify that they are up-to-date and verify such to the ARCHITECT/ENGINEER, before the ARCHITECT/ENGINEER issues the certificate of payment for that pay period. 1.1.9.7. Based upon his/her determinations and reports made under Section 1.1.9.5 of this Agreement and upon the Contractor's applications for payment, the ARCHITECT/ENGINEER shall once every month, after an on-site conference between the State, the Contractor and the ARCHITECT/ENGINEER, determine the amount then owing to the Contractor and shall then issue a certificate of payment for the amount agreed upon. The issuance of a Certificate for Payment shall constitute a representation by the ARCHITECT/ENGINEER to the State, based on such ARCHITECT/ENGINEER'S determination and report and the data supplied to him/her by the Contractor (without affecting his/her duties defined in Section 1.1.9.5.), that the work has progressed to the point indicated; that the quality of the work is in accordance with the Contract Documents (subject to the results of any specified subsequent tests required by the Contract Documents, to immaterial and insubstantial deviations from the Contract Documents, which will be corrected prior to completion, and to any further specific qualifications stated in the Certificate for Payment); and that the Contractor is entitled to such payment in the amount certified. Provided, however, the issuance of such certificate will not affect any obligations of the Contractor to the State. By issuing a certificate for payment, the ARCHITECT/ENGINEER shall not be deemed to represent that he/she has made any examination to ascertain how and for what purpose the Contractor has used the monies paid on account of the contract sum. ARCHITECT/ENGINEER shall not accept any part of the work on behalf of the State; ARCHITECT/ENGINEER may only recommend acceptance. Final acceptance is a right reserved solely to the State. 1.1.9.8. The ARCHITECT/ENGINEER shall be, in the first instance, the interpreter of the requirements of all Construction Documents, and shall have all requisite authority relating thereto for the purposes of authorizing the Contractor to proceed or stop with any component of the project after consultation and agreement with the State. The ARCHITECT/ENGINEER shall not be liable to the State for any loss or cost incurred by the State arising from delays in the construction schedule caused by any decision made by the ARCHITECT/ENGINEER in the reasonable exercise of professional judgment either to exercise or not to exercise his/her authority to stop the Work. 1.1.9.9. The ARCHITECT/ENGINEER shall review and respond to shop drawings, samples, and other submissions of the Contractor as in conformance with the design concept and information in the Contract Documents and the designs and plans relating to the project until approved or not requiring re-submission. The ARCHITECT/ENGINEER shall also review the submittal log at construction meetings and report to the State, on a monthly basis, their findings thereon. 1.1.9.10. The ARCHITECT/ENGINEER shall prepare all change orders and supporting data for the State's approval. 1.1.9.11. The ARCHITECT/ENGINEER shall conduct inspections to determine the Dates of Substantial Completion and Final Completion and shall receive written guarantees and related documents assembled by the Contractors and shall issue a final certificate of payment in accordance with Section 1.1.9.6. 1.1.9.12. The ARCHITECT/ENGINEER shall be responsible for system commissioning in accordance with the BGS Design Guidelines and as indicated in the BGS Commissioning Guidelines. Please see the BGS website xxxx://xxx.xxxxxxx.xxx/facilities/forms . The ARCHITECT/ENGINEER shall inspect, and document, each and every system to ensure that it complies with design intent, including but not limited to: system installation, system operation, and seasonal changeover. 1.1.9.13. Except in the manner specifically provided for herein, the ARCHITECT/ENGINEER shall not be responsible to the State for the acts or omissions of the Contractor or any of the Contractor’s agents or employees, or any other person not an employee or agent of the ARCHITECT/ENGINEER performing work on the Project. The ARCHITECT/ENGINEER shall be responsible for and shall pay the amount of any increase in the total Contract Price or the total Change Order(s) Price, which increase results from an error, inconsistency, or omission in the Contract Documents or instructions. 1.1.9.14. ARCHITECT/ENGINEER shall furnish to the State, a complete set of marked-up drawings and specifications showing all the changes to the Construction Documents made by Addenda, Change Orders, Shop Drawings, RFIs and other information received from the Clerk; and General Contractor’s As-built markups. The changes to the drawings are to be created on a separate layer in the DWG set and highlighted in a box, cloud or the like in the PDF set. The specifications are also to differentiate the changes made by highlighting in a box, cloud, etc. and be provided in Microsoft Word. These drawings and specifications shall be supplied within three (3) months of the date of Substantial Completion and before final payment. 1.1.9.15. Architect/Engineer (and design team members as required) shall conduct a one-year warranty inspection of the completed construction project between the eleventh and twelfth month from the date of substantial completion and shall issue a list of defective items needing correction to the Contractor.

  • Completion of Negotiations This Agreement represents complete collective bargaining and full agreement by the District and the Federation with respect to wages, hours of employment, and all other terms and conditions of employment which shall prevail during the term or terms hereof. This Agreement expresses the entire understanding between the parties and supersedes all previous agreements between them, written or oral. Any matter or subject not herein covered has been satisfactorily adjusted, compromised, or waived by the parties for the life of this Agreement.

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