THE REGULATIONS. Unless otherwise determined by Parent prior --------------- to the Effective Time, the regulations of Merger Sub in effect at the Effective Time shall be the Regulations of the Surviving Corporation, until duly amended in accordance with the terms thereof and the OGCL.
THE REGULATIONS. 4.1 ‘Regulations’ shall apply for determining the rights and obligations of and the action which is to be taken by each party to this Agreement.
THE REGULATIONS. [4] In setting out the scheme of the Regulations, I borrow heavily from the outline that this Court recently provided in Pfizer Canada Inc. v. Teva Canada Limited, 2016 FCA 161, 483 N.R. 275 at paras. 13-18 (Venlafaxine). I also describe the Regulations as they existed at the relevant time. They were recently substantially amended by the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations, SOR/2017-166. [5] In order to market a new drug in Canada, an innovator drug manufacturer must, among other things, file a new drug submission and receive approval in the form of a notice of compliance from the Minister of Health. As part of that process, the Regulations permit the manufacturer to list in a patent register all of the patents relevant to the submission. [6] A generic drug manufacturer wishing to make and market a generic version of the drug may submit an abbreviated new drug submission, using the results of clinical trials regarding safety and effectiveness undertaken by the innovator to demonstrate that the generic formulation is bioequivalent to the innovator’s. This dispenses with the need for the generic manufacturer to undertake its own clinical trials. [7] In its submission, the generic drug manufacturer must address any patent listed in the patent register concerning the innovator drug. It does so either by stating that it is not seeking the issuance of an NOC until the patent expires or by alleging that the patent is not valid or will not be infringed by the making, using or selling of the generic drug. If it takes the latter course, it must serve a notice of allegation containing a detailed statement of the factual and legal bases for the allegation. [8] An innovator who wishes to challenge the allegation of invalidity or non-infringement in the NOA must apply to the Federal Court within 45 days for an order prohibiting the Minister of Health from issuing an NOC for the generic product before the expiry of the patent or patents that are the subject of the NOA. The bringing of a prohibition application triggers what is sometimes referred to as a regulatory stay: the Minister may not issue an NOC to the generic drug company for 24 months or until the application is withdrawn, discontinued or dismissed. [9] If a prohibition application is ultimately unsuccessful either at first instance or on appeal, or if it is discontinued or withdrawn, section 8 of the Regulations gives the generic company a right of action against the ...
THE REGULATIONS. In the last three years the Seller has not been a party to a relevant transfer (as defined in the Transfer of Undertakings (Protection of Employment) Regulations 1981 or TUPE) in relation to the Business.
THE REGULATIONS. 1. The unnecessary interference with fire safety equipment or the discharge of fire extinguishers is considered a serious act of vandalism. There will be a charge of €500 for this breach of the terms herein levied against the individual responsible or equally against all occupants of the Apartment if the individual cannot be identified.
THE REGULATIONS. The Regulations of Merger Sub in effect immediately prior to the Effective Time will be the Regulations of the Surviving Corporation (the "REGULATIONS") until amended in accordance with the Articles, such Regulations and the OGCL.
THE REGULATIONS. The parties agree that it is not intended that the contracts of employment of any Employee will have effect on the Transfer Date or, as appropriate, on the Termination Date, as if originally made between the Buyer and the Employee pursuant to the Regulations.
THE REGULATIONS. The Supplier shall indemnify, and keep indemnified, EMH in full against all cost, expenses, damages and losses (whether direct or indirect), including any interest, penalties, and reasonable legal and other professional fees awarded against or incurred or paid by EMH as a result of or in connection with any breach of this clause 18.4.