NADAs. Notwithstanding any assistance provided by OSG in acquiring approval from the FDA of any NADA, ViroPharma shall own all right, title and interest in and to each NADA.
NADAs Sample Clauses
Related to NADAs
Medi Cal/daily service logs and notes and other documents used to record provision of services provided by instructional assistants, behavior intervention aides, bus aides, and supervisors
Medical Verification The Town may require medical verification of an employee’s absence if the Town perceives the employee is abusing sick leave or has used an excessive amount of sick leave. The Town may require medical verification of an employee’s absence to verify that the employee is able to return to work with or without restrictions.
Localization Should any Seller Affiliate and any Customer Affiliate wish to enter into an agreement for the provision of Deliverables, Products and/or Services ("Local Agreement") in the Netherlands, Canada, Hong Kong, the United States, Australia, Ireland, Singapore, South Africa or the United Arab Emirates (as applicable) Local Agreement(s) can be agreed between the Parties and added as Exhibit(s) to this Agreement by way of addendum. The terms of this Agreement shall be incorporated into each such Local Agreement except to the extent that the Local Agreement expressly states that any amendments shall take precedence.
FDA As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.
Video Surveillance All video surveillance will be directed by the YSU police department.
Ibid For greater certainty and without limiting section 10.1, the Funder is not liable for how the HSP and the HSP’s Personnel and Volunteers carry out the Services and is therefore not responsible to the HSP for such Services. Moreover, the Funder is not contracting with or employing any HSP’s Personnel and Volunteers to carry out the terms of this Agreement. As such, it is not liable for contracting with, employing or terminating a contract with or the employment of any HSP’s Personnel and Volunteers required to carry out this Agreement, nor for the withholding, collection or payment of any taxes, premiums, contributions or any other remittances due to government for the HSP’s Personnel and Volunteers required by the HSP to carry out this Agreement.
Safety Training Pursuant to Missouri Revised Statute Section 292.675, Contractors and subcontractors who sign a contract to work on public works projects must provide a 10-hour OSHA construction safety program, or similar program approved by the Department of Labor and Industrial Relations, to be completed by their on-site employees within sixty (60) days of beginning work on the construction project. Contractors and subcontractors in violation of this provision will forfeit to the public body $2,500 plus $100 a day for each employee who is employed without training. Public bodies and contractors may withhold/assess these penalties from the payment due to those contractors and subcontractors if found to be in non-compliance.
Employee Verification In accordance with Neb. Rev.
Pharmacy Pharmacy hereby represents that neither Pharmacy, nor, to the best of Pharmacy’s knowledge, Pharmacist, Pharmacy’s employees, agents or independent
Message Screening 7.4.4.4.1 BellSouth shall set message screening parameters so as to accept valid messages from MRC local or tandem switching systems destined to any signaling point within BellSouth’s SS7 network where the MRC switching system has a valid signaling relationship. 7.4.4.4.2 BellSouth shall set message screening parameters so as to pass valid messages from MRC local or tandem switching systems destined to any signaling point or network accessed through BellSouth’s SS7 network where the MRC switching system has a valid signaling relationship. 7.4.4.4.3 BellSouth shall set message screening parameters so as to accept and pass/send valid messages destined to and from MRC from any signaling point or network interconnected through BellSouth’s SS7 network where the MRC SCP has a valid signaling relationship.
