Quality of Materials and workmanship The Contractor shall ensure that the Construction, Materials and workmanship are in accordance with the requirements specified in this Agreement, Specifications and Standards and Good Industry Practice.
Materials and Supplies The cost of materials and supplies is allowable. Purchases should be charged at their actual prices after deducting all cash discounts, trade discounts, rebates, and allowances received. Withdrawals from general stores or stockrooms should be charged at cost under any recognized method of pricing, consistently applied. Incoming transportation charges are a proper part of materials and supply costs.
Third Party Materials The Application may display, include, or make available third-party content (including data, information, applications, and other products, services, and/or materials) or provide links to third-party websites or services, including through third- party advertising ("Third-Party Materials"). You acknowledge and agree that Company is not responsible for Third-Party Materials, including their accuracy, completeness, timeliness, validity, copyright compliance, legality, decency, quality, or any other aspect thereof. Company does not assume and will not have any liability or responsibility to you or any other person or entity for any Third-Party Materials. Third-Party Materials and links thereto are provided solely as a convenience to you, and you access and use them entirely at your own risk and subject to such third parties' terms and conditions.
API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.
SHOP DRAWINGS, PRODUCT DATA AND SAMPLES 4.12.1 Shop Drawings are drawings, diagrams, schedules and other, data specially prepared for the Work by the Contractor or any Subcontractor, manufacturer, supplier or distributor to illustrate some portion of the Work. 4.12.2 Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams and other information furnished by the Contractor to illustrate a material, product or system for some portion of the Work. 4.12.3 Samples are physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged. 4.12.4 The Contractor shall review, approve and submit, with reasonable promptness and in such sequence as to cause no delay in the Work or in the work of the State or any separate contractor, all Shop Drawings, Product Data and Samples required by the Contract Documents. 4.12.5 By approving and submitting Shop Drawings, Product Data and Samples, the Contractor represents that he / she has determined and verified all materials, field measurements, and field construction criteria related thereto, or will do so, and that he / she has checked and coordinated the information contained within such submittals with the requirements of the Work and of the Contract Documents. 4.12.6 The Contractor shall not be relieved of responsibility for any deviation from the requirements of the Contract Documents by the Architect's approval of Shop Drawings, Product Data or Samples under Subparagraph 2.2.7 of these General Conditions unless the Contractor has specifically informed the Architect and the State in writing of such deviation at the time of sub- mission and the Architect and the State has given written approval to the specific deviation. The Contractor shall not be relieved from responsibility for errors or omissions in the Shop Drawings, Product Data or Samples by the Architect's approval thereof. 4.12.7 The Contractor shall direct specific attention, in writing or on resubmitted Shop Drawings, Product Data or Samples, to revisions other than those requested by the Architect on previous submittals. 4.12.8 No portion of the Work requiring submission of a Shop Drawing, Product Data or Sample shall be commenced until the submittal has been approved by the Architect as provided in Subparagraph 2.2.7 of these General Conditions. All such portions of the Work shall be in accordance with approved submittals.
Materials and Methods 86 2.1 PARTICIPANTS 87 We used baseline measurements from a convenience sample of participants in previous (3) and 88 ongoing cohort studies investigating the effects of rehabilitation on balance responses (Table 1). PD 89 participants were mild-moderate with bilateral symptoms (Xxxxx and Xxxx stage 2-3 (13)). All 90 participants provided written informed consent and all study procedures were approved by Institutional 91 Review Boards at the Georgia Institute of Technology and Emory University.
Tests and Preclinical and Clinical Trials The preclinical studies and clinical trials conducted by or, to the Company’s knowledge, on behalf of the Company, that are described in the Registration Statement, the Pricing Disclosure Package and the Prospectus, as applicable, and are intended to be submitted to the U.S. Food and Drug Administration (the “FDA”) or other comparable government entities, were and, if still ongoing, are being conducted in all material respects in accordance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all Authorizations and Applicable Laws, including, without limitation, current Good Clinical Practices and Good Laboratory Practices and any applicable rules and regulations of the jurisdiction in which such trials and studies are being conducted; the descriptions of the results of such studies and trials contained in the Registration Statement, the Pricing Disclosure Package and the Prospectus are, to the Company’s knowledge, accurate and complete in all material respects and fairly present the data derived from such studies and trials; except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package and the Prospectus, the Company is not aware of any studies or trials, the results of which the Company believes reasonably call into question the study or trial results described or referred to in the Registration Statement, the Pricing Disclosure Package and the Prospectus when viewed in the context in which such results are described and the clinical stage of development; and, except to the extent disclosed in the Registration Statement, the Pricing Disclosure Package or the Prospectus, the Company has not received any written notices or written correspondence from the FDA or any governmental entity requiring the termination or suspension of any preclinical studies or clinical trials conducted by or on behalf of the Company, other than ordinary course communications with respect to modifications in connection with the design and implementation of such trials, copies of which communications have been made available to you.
Regulatory Materials (a) On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “Program Regulatory Materials”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. (b) If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “Regulatory Transfer Date” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.
MATERIALS AND WORKMANSHIP (a) All equipment, material, and articles incorporated into the work covered by this Agreement shall be new and of the most suitable grade for the purpose intended, unless otherwise specifically provided in this Agreement. (b) Seller shall obtain Company approval of the machinery and mechanical and other equipment to be incorporated into the work. When required by Company, Seller shall also obtain Company's approval of the material or articles which Seller contemplates incorporating into the work. When so directed, Seller shall submit samples for approval at Seller's expense. Machinery, equipment, material, and articles that do not have the required approval shall be installed or used at the risk of subsequent rejection. (c) References in the specifications or drawings to equipment, material, articles, or patented processes by trade name, make, or catalog number, shall be regarded as establishing a standard of quality and shall not be construed as limiting competition. Seller may, with Company's written approval, use any equipment, material, article, or process that is equal to that specified, unless the words "No Substitution" follow the listing of the item in the specifications or drawings. Unless otherwise agreed, modifications due to use of “or equal” supplies, is at Seller’s expense. (d) All work under this Agreement shall be performed in a skillful and workmanlike manner. Company may require, in writing, Seller to remove from the work any employee Company deems incompetent, careless, or otherwise objectionable.
Operator Materials Operator retains all right, title and interest in and to any and all of Operator’s software, materials, tools, forms, documentation, training and implementation materials and intellectual property (“Operator Materials”). Operator grants to the LEA a personal, nonexclusive license to use the Operator Materials for its own non-commercial, incidental use as set forth in the Service Agreement. Operator represents that it has all intellectual property rights necessary to enter into and perform its obligations in this DPA and the Service Agreement, warrants to the District that the District will have use of any intellectual property contemplated by the Service Agreement free and clear of claims of any nature by any third Party including, without limitation, copyright or patent infringement claims, and agrees to indemnify the District for any related claims.
