Protocols Each party hereby agrees that the inclusion of additional protocols may be required to make this Agreement specific. All such protocols shall be negotiated, determined and agreed upon by both parties hereto.
Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, “studies”) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies.
Signaling protocol The Parties will interconnect their networks using SS7 signaling where Technically Feasible and available as defined in GR 905 Telcordia Standards including ISDN User Part (ISUP) for trunk signaling and TCAP for CCS-based features in the Interconnection of their networks. All Network Operations Forum (NOF) adopted standards shall be adhered to. Where available, CenturyLink signaling services to link its Signaling Transfer Points (STPs) for CLEC switches which connect to CenturyLink’s STPs via “A” links or for CLEC’s STPs to connect to CenturyLink’s STPs via “D” links which are dedicated to the transport of signaling for local Interconnection, may be ordered from the CenturyLink Tariff.
Protocol The attached Protocol shall be an integral part of this Agreement.
Project Implementation Manual The Recipient, through the PCU, shall: (i) take all action required to carry out Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4 (ii) of the Project in accordance with the provisions and requirements set forth or referred to in the Project Implementation Manual; (ii) submit recommendations to the Association for its consideration for changes and updates of the Project Implementation Manual as they may become necessary or advisable during Project implementation in order to achieve the objective of Parts 1.1, 1.3, 1.4, 2, 3.1(b), 3.2, 3.3 and 4(ii) of the Project; and (iii) not assign, amend, abrogate or waive the Project Implementation Manual or any of its provisions without the Association’s prior agreement. Notwithstanding the foregoing, if any of the provisions of the Project Implementation Manual is inconsistent with the provisions of this Agreement, the provisions of this Agreement shall prevail and govern.
Proposed Policies and Procedures Regarding New Online Content and Functionality By October 31, 2017, the School will submit to OCR for its review and approval proposed policies and procedures (“the Plan for New Content”) to ensure that all new, newly-added, or modified online content and functionality will be accessible to people with disabilities as measured by conformance to the Benchmarks for Measuring Accessibility set forth above, except where doing so would impose a fundamental alteration or undue burden.
a) When fundamental alteration or undue burden defenses apply, the Plan for New Content will require the School to provide equally effective alternative access. The Plan for New Content will require the School, in providing equally effective alternate access, to take any actions that do not result in a fundamental alteration or undue financial and administrative burdens, but nevertheless ensure that, to the maximum extent possible, individuals with disabilities receive the same benefits or services as their nondisabled peers. To provide equally effective alternate access, alternates are not required to produce the identical result or level of achievement for persons with and without disabilities, but must afford persons with disabilities equal opportunity to obtain the same result, to gain the same benefit, or to reach the same level of achievement, in the most integrated setting appropriate to the person’s needs.
b) The Plan for New Content must include sufficient quality assurance procedures, backed by adequate personnel and financial resources, for full implementation. This provision also applies to the School’s online content and functionality developed by, maintained by, or offered through a third-party vendor or by using open sources.
c) Within thirty (30) days of receiving OCR’s approval of the Plan for New Content, the School will officially adopt, and fully implement the amended policies and procedures.
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
Research Use Reporting To assure adherence to NIH GDS Policy, the PI agrees to provide annual Progress Updates as part of the annual Project Renewal or Project Close-out processes, prior to the expiration of the one (1) year data access period. The PI who is seeking Renewal or Close-out of a project agree to complete the appropriate online forms and provide specific information such as how the data have been used, including publications or presentations that resulted from the use of the requested dataset(s), a summary of any plans for future research use (if the PI is seeking renewal), any violations of the terms of access described within this Agreement and the implemented remediation, and information on any downstream intellectual property generated from the data. The PI also may include general comments regarding suggestions for improving the data access process in general. Information provided in the progress updates helps NIH evaluate program activities and may be considered by the NIH GDS governance committees as part of NIH’s effort to provide ongoing stewardship of data sharing activities subject to the NIH GDS Policy.
Commercialization Reports Throughout the term of this Agreement and during the Sell-Off Period, and within thirty (30) days of December 31st of each year, Company will deliver to University written reports of Company’s and Sublicensees’ efforts and plans to develop and commercialize the innovations covered by the Licensed Rights and to make and sell Licensed Products. Company will have no obligation to prepare commercialization reports in years where (a) Company delivers to University a written Sales Report with active sales, and (b) Company has fulfilled all Performance Milestones. In relation to each of the Performance Milestones each commercialization report will include sufficient information to demonstrate achievement of those Performance Milestones and will set out timeframes and plans for achieving those Performance Milestones which have not yet been met.
Technical Specifications The Technical Specifications furnished on the CD are intended to establish the standards for quality, performance and technical requirements for all labor, workmanship, material, methods and equipment necessary to complete the Work. When specifications and drawings are provided or referenced by the County, these are to be considered part of the Scope of Work, and to be specifically documented in the Detailed Scope of Work. For convenience, the County supplied specifications, if any, and the Technical Specifications furnished on the CD.
