Review Protocol A narrative description of how the Claims Review was conducted and what was evaluated.
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.
Procurement procedures 11.1 The Recipient must secure the best value for money and shall act in a fair, open and non-discriminatory manner in all purchases of goods and services.
Review Procedures a. In consultation with the Illinois SHPO, NRCS shall identify those undertakings with little to no potential to affect historic properties and list those undertakings in Appendix A. Upon the determination by the CRS that a proposed undertaking is included in Appendix A, the NRCS is not required to consult further with the SHPO for that undertaking. A list of undertakings with the potential to affect historic properties comprises Appendix B.
b. The lists of undertakings provided in Appendices A and B may be modified through consultation and written agreement between the NRCS State Conservationist and the SHPO without requiring an amendment to this Illinois Prototype Agreement. The NRCS State Office will maintain the master list and will provide an updated list to all consulting parties with an explanation of the rationale for classifying the practices accordingly.
c. Undertakings identified in Appendix B shall require further review as outlined in Stipulation V.
a. The NRCS shall consult with the SHPO to define the undertaking’s APE, identify and evaluate historic properties that may be affected by the undertaking, assess potential effects, and identify strategies for resolving adverse effects prior to implementing the undertaking.
1) NRCS may provide its proposed APE, identification of historic properties and/or scope of identification efforts, and assessment of effects in a single transmittal to the SHPO, provided this documentation meets the substantive standards in 36 CFR Part 800.4-5 and 800.11.
2) The NRCS shall attempt to avoid adverse effects to historic properties whenever possible; where historic properties are located in the APE, NRCS shall describe how it proposes to modify, buffer, or move the undertaking to avoid adverse effects to historic properties.
3) Where the NRCS proposes a finding of "no historic properties affected" or "no adverse effect" to historic properties, the SHPO shall have 30 calendar days from receipt of this documented description and information to review it and provide comments. The NRCS shall take into account all timely comments.
i. If the SHPO, or another consulting party, disagrees with NRCS' findings and/or determination, it shall notify the NRCS within the thirty (30) calendar daytime period. The NRCS shall consult with the SHPO or other consulting party to attempt to resolve the disagreement. If the disagreement cannot be resolved through this consultation, NRCS shall follow the dispute resolution process in Stipulation VIII below.
ii. If the SHPO does not respond to the NRCS within the thirty (30) calendar day period and/or the NRCS receives no objections from other consulting parties, or if the SHPO concurs with the NRCS' determination and proposed actions to avoid adverse effects, the NRCS shall document the concurrence/lack of response within the review time noted above and may move forward with the undertaking.
4) Where a proposed undertaking may adversely affect historic properties, NRCS shall describe proposed measures to minimize or mitigate the adverse effects, and follow the process in 36 CFR Part 800.6, including consultation with other consulting patties and notification to the ACHP, to develop a Memorandum of Agreement to resolve the adverse effects. Should the proposed undertaking have the potential to adversely affect a known NHL, the NRCS shall, to the maximum extent possible, undertake such planning and actions that may be necessary to minimize harm to the NHL in accordance with 54 U.S.C. § 306107 of the NHPA and 36 CFR Part 800.6 and 800.10, including consultation with the ACHP and respective National Park Service, Regional National Historic Landmark Program Coordinator, to develop a Memorandum of Agreement.
d. NRCS will conduct archaeological surveys and will submit reports and other documentation to SHPO for review and comment. When no archaeological sites have been located by the archaeological survey, NRCS may proceed with the proposed undertaking. Reports for negative surveys must be submitted to SHPO on a quarterly basis. All positive and negative reports submitted to SHPO will be sent digitally for submission to the Inventory of Illinois Archaeological Sites (IAS) data file maintained by staff at the Illinois State Museum (ISM) housed under the Illinois Department of Natural Resources (IDNR). The NRCS further agrees that access to specific site location data will be restricted to the CRS, the NRCS field personnel installing conservation practices adjacent to the cultural resource, and the landowner. Specific site location information for individual projects will be maintained in a secure cultural resources file kept in the field offices and will not be available to the public.
e. Curation: NRCS personnel will not collect artifactual material during routine field inspections. However, if a professional survey, evaluation testing, or mitigation is required, NRCS shall ensure that all materials and records resulting from cultural resources surveys or data recovery activities on federal or state property are curated by the Illinois State Museum. The NRCS shall ensure that all records resulting from cultural resource surveys or data recovery activities on private property are curated by the Illinois State Museum or an equivalent curation facility in accordance with 36 CFR Part 79. Subject to the landowner's permission, all objects resulting from cultural resources surveys or data recovery activities are maintained by the Illinois State Museum or equivalent research institution until their analysis is complete and they are returned to their owner(s). Although landowners will be encouraged to donate artifactual material, it is understood that objects collected on private land remain the property of the landowner(s) unless the landowner(s) donates the material to the Illinois State Museum or equivalent research institution. This excludes burial goods, as stipulated by XXXXXX.
Random Drug Testing All employees covered by this Agreement shall be subject to random drug testing in accordance with Appendix D.
Safety Procedures The Contractor shall:
(a) comply with all applicable safety regulations according to Attachment H;
(b) take care for the safety of all persons entitled to be on the Site;
(c) use reasonable efforts to keep the Site and Works clear of unnecessary obstruction so as to avoid danger to these persons;
(d) provide fencing, lighting, guarding and watching of the Works until completion and taking over under clause 10 [Employer's Taking Over]; and
(e) provide any Temporary Works (including roadways, footways, guards and fences) which may be necessary, because of the execution of the Works, for the use and protection of the public and of owners and occupiers of adjacent land.
Notification Procedures To address non-compliance, the receiving Competent Authority would notify the providing Competent Authority pursuant to Article 5 of the IGA. The notification procedures would differ depending upon whether the receiving Competent Authority seeks to address administrative or other minor errors or significant non-compliance.
Application Procedures i) An employee applies for a listing on the system-wide registry through the employee’s Human Resources Department by completing the form in Appendix A.
ii) The institution will immediately forward the completed form to the PSEA who will list eligible employees on the system-wide registry.
iii) A registrant is responsible to ensure the information is current and to immediately notify the Employer and the local Union if the registrant is no longer available for employment through the Registry.
AUDIT REVIEW PROCEDURES Any dispute concerning a question of fact arising under an interim or post audit of this AGREEMENT that is not disposed of by agreement, shall be reviewed by ALAMEDA CTC’s Deputy Executive Director of Finance and Administration. Not later than thirty (30) calendar days after issuance of the final audit report, CONSULTANT may request a review by ALAMEDA CTC’s Deputy Executive Director of Finance and Administration of unresolved audit issues. The request for review will be submitted in writing. Neither the pendency of a dispute nor its consideration by ALAMEDA CTC will excuse CONSULTANT from full and timely performance, in accordance with the terms of this AGREEMENT. CONSULTANT and subconsultants’ contracts, including cost proposals and ICRs, may be subject to audits or reviews such as, but not limited to, an AGREEMENT Audit, an Incurred Cost Audit, an ICR Audit, or a certified public accountant (“CPA”) ICR Audit Workpaper Review. If selected for audit or review, the AGREEMENT, cost proposal and ICR and related workpapers, if applicable, will be reviewed to verify compliance with 48 CFR, Chapter 1, Part 31 and other related laws and regulations. In the instances of a CPA ICR Audit Workpaper Review it is CONSULTANT’s responsibility to ensure federal, state, or local government officials are allowed full access to the CPA’s workpapers including making copies as necessary. The AGREEMENT, cost proposal, and ICR shall be adjusted by CONSULTANT and approved by ALAMEDA CTC to conform to the audit or review recommendations. CONSULTANT agrees that individual terms of costs identified in the audit report shall be incorporated into the contract by this reference if directed by ALAMEDA CTC at its sole discretion. Refusal by CONSULTANT to incorporate audit or review recommendations, or to ensure that the federal, state, or local governments have access to CPA workpapers, will be considered a breach of contract terms and cause for termination of the AGREEMENT and disallowance of prior reimbursed costs.
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.
