Statutory appeal rights set form in Chapter 3319, ORC, shall not be applicable to members.
Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.
statutory body means any body declared under clause 13 to be a statutory body for the purposes of this Schedule;
statutory authority means Central or State Government, quasi-Government, administrative, judicial, public or statutory body, department, instrumentality, agency, authority, board entrusted with and carrying any statutory functions, as required from time to time in connection with performance by the Preferred Bidder of its obligations hereunder;
Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).
Appeal means a request for a review of the Floodplain Administrator's interpretation of any provision of this ordinance.
ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.
Court of Appeal means the division of the Supreme Court referred to in section 7(1)(b);
Denial means the process of refusing to grant a license after OCCL receives an application. This constitutes refusal of permission to operate.
STATUTORY OFF means the off day per week or the compensatory off day in lieu thereof which the Transport Supplier is required to give to his/her operating crew as per the Motor Transport Workers Act, 1961 in respect of which adequate relief driver/crew shall be provided at no extra cost.
Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.
Notice of Appeal means a notice given pursuant to Condition 6.2.
Appeals Tribunal or “AT” means the Body responsible for hearing and determining appeals set out in section 9;
Claimant means a person or entity who or which submits a Claim Form to the Claims Administrator seeking to be eligible to share in the proceeds of the Settlement Fund.
Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.
Statutory Committee means any official committee of unsecured creditors in any of the Chapter 11 Cases pursuant to Section 1102 of the Bankruptcy Code.
NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.
Preliminary Approval Order means the proposed Order Granting Preliminary Approval of Class Action Settlement, Approving Form and Manner of Notice, and Setting Date for Hearing on Final Approval of Settlement, which, subject to the approval of the Court, shall be substantially in the form attached hereto as Exhibit A.
Board of Appeals means the local board of appeals as created by local ordinance.
Statutory Auditors means a firm of chartered accountants appointed in terms of Section 224 of the Companies Act, 1956 and acting as the statutory auditors of the Concessionaire.
COVID-19 case means a person who:
Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.
Statutory Auditor means the auditor of a Company appointed under the provisions of the Companies Act, 1956 or under the provisions of any other applicable governing law;
Appeals Board means the commissioners and deputy commissioners of the Workers’ Compensation Appeals Board acting en banc, in panels, or individually.
statutory notice means a notice served by the company under the Companies Acts requiring particulars of interests in shares or of the identity of persons interested in shares.
Reconsideration means review by the director of an insurer’s Notice of Closure.
Patent Term Extension means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.