Entry Into Commercial Service 15.1 Commercial Operation Date (COD)
Study Population Infants who underwent creation of an enterostomy receiving postoperative care and awaiting enterostomy closure: to be assessed for eligibility: n = 201 to be assigned to the study: n = 106 to be analysed: n = 106 Duration of intervention per patient of the intervention group: 6 weeks between enterostomy creation and enterostomy closure Follow-up per patient: 3 months, 6 months and 12 months post enterostomy closure, following enterostomy closure (12-month follow-up only applicable for patients that are recruited early enough to complete this follow-up within the 48 month of overall study duration).
RE-WEIGHING PRODUCT Deliveries are subject to re- weighing at the point of destination by the Authorized User. If shrinkage occurs which exceeds that normally allowable in the trade, the Authorized User shall have the option to require delivery of the difference in quantity or to reduce the payment accordingly. Such option shall be exercised in writing by the Authorized User.
Reconsiderations and Appeals If you experience a problem relating to an authorization review, benefit denial, or other aspect of this plan, we have internal and external procedures to help you resolve your issue. The following sections detail the processes and procedures for filing: • Administrative Appeals; • Medical Reconsiderations and Appeals (including expedited appeals); • Prescription Drug Appeals: and
Regulatory Approval 25.1 The Parties understand and agree that this Agreement and any amendment or modification hereto will be filed with the Commission for approval in accordance with Section 252 of the Act and may thereafter be filed with the FCC. The Parties believe in good faith and agree that the services to be provided under this Agreement are in the public interest. Each Party covenants and agrees to fully support approval of this Agreement by the Commission or the FCC under Section 252 of the Act without modification.
Trials The Ship shall run the following test and trials:
Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.
Legal Appeals a. Nothing contained in these provisions is intended to limit or impair the rights of any vendor or Contractor to seek and pursue remedies of law through the judicial process. Appendix C Appendix C, Contract Modification Procedure, attached hereto, is hereby expressly made a part of this Contract as fully as if set forth at length herein. Appendix D Appendix D, Pricing Schedules, attached hereto, is hereby expressly made a part of this Contract as fully as if set forth at length herein. The Parties expressly agree that these prices are established as “maximum Not-To-Exceed prices”. The Contractor acknowledges that any mini-bid under this Centralized Contract which includes pricing in excess of the “maximum Not-To-Exceed price” shall be rejected by the Authorized User. Amendments to Appendix D, Pricing Schedules, shall be processed in accordance with Appendix C, Contract Modification Procedure, section 4.8, OGS Centralized Contract Modifications and section 4.23 Price Adjustments for OGS Centralized Contracts. Appendix E Appendix E, Report of Contract Purchases, attached hereto, is hereby expressly made a part of this Contract as fully as if set forth at length herein. OGS reserves the right to make unilateral changes to this Report of Contract Purchases document. Appendix F Appendix F, Project Based Information Technology Consulting Services Processes and Forms, attached hereto, is hereby expressly made a part of this Contract as fully as if set forth at length herein. OGS reserves the right to change the processes and forms set forth Appendix F in non-material and substantive ways without seeking a contract amendment. Appendix F is comprised of the following attachments:
Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.
EDUCATIONAL IMPROVEMENT A leave of absence without pay of up to one (1) contract year may be granted to any employee, upon application, for the purpose of engaging in study at an accredited college or university reasonably related to professional responsibilities.