Definitions Principles of Construction Section 1.1 Definitions 1 Section 1.2 Principles of Construction 13 ARTICLE II
General Principle During the term of this Agreement, as among Licensee, PPD and GenuPro, Licensee shall be responsible for development and marketing of Compounds in such countries of the Territory as it deems appropriate, consistent with its obligations under this Agreement. Licensee will use Diligent Efforts to submit applications for regulatory approval to market a Licensed Product in the [*] and [*]. Licensee will select in its sole discretion, prior to NDA submission, at least [*] Key Countries in which Licensee shall use Diligent Efforts to submit applications for regulatory approval to market a Licensed Product, wherein [*] of such countries are [*]. Licensee shall have responsibility for obtaining all necessary regulatory approvals to do so, and Licensee, or its subcontractors, shall hold legal title of any Investigational New Drug Application (“IND”) and NDA filed by Licensee with the United States Food and Drug Administration, or any equivalents of such items in countries within the Territory, and shall assume full responsibility for all development and marketing activities pursuant to and in support of such application.
Definitions and Principles of Construction Section 1.1 Defined Terms 1 Section 1.2 Principles of Constructions 1
Quality Agreement Each Party will comply with the terms of the Quality Agreement in the performance of its obligations hereunder including record retention, audits and inspections, change control, adverse events and product recall. The Parties will conduct periodic Product quality reviews in accordance with the terms of the Quality Agreement.
General Construction Principles Words in any gender are deemed to include the other genders. The singular is deemed to include the plural and vice versa. The headings and underlined paragraph titles are for guidance only and have no significance in the interpretation of this Agreement.
General Principles All provisions herein shall be subject to the requirements of all applicable Law and any collective bargaining, works council or similar agreement or arrangement with any labor union, works council or other labor representative (each, a “Labor Agreement”). Notwithstanding anything in this Agreement to the contrary, if the terms of a Labor Agreement or applicable Law require that any Assets or Liabilities be retained or assumed by, or transferred to, a Party in a manner that is different than what is set forth in this Agreement, such retention, assumption or transfer shall be made in accordance with the terms of such Labor Agreement and applicable Law and shall not be made as otherwise set forth in this Agreement; provided that, in such case, the Parties shall take all necessary action to preserve the economic terms of the allocation of Assets and Liabilities contemplated by this Agreement. The provisions of this Agreement shall apply in respect of all jurisdictions.
Definitions and Conventions Capitalized terms used in the Purchase and Sale Agreement shall have (unless otherwise provided elsewhere therein) the following respective meanings:
Principles of Construction All references to sections and schedules are to sections and schedules in or to this Agreement unless otherwise specified. All uses of the word “including” shall mean “including, without limitation” unless the context shall indicate otherwise. Unless otherwise specified, the words “hereof,” “herein” and “hereunder” and words of similar import when used in this Agreement shall refer to this Agreement as a whole and not to any particular provision of this Agreement. Unless otherwise specified, all meanings attributed to defined terms herein shall be equally applicable to both the singular and plural forms of the terms so defined.
Supply Agreement Buyer shall have executed and delivered the Supply Agreement to the Company.
Manufacturing Agreement Each of the Sellers (as applicable) shall have executed and delivered to the Buyer the Manufacturing Agreement with respect to the portion of the Business conducted at the applicable Facility.
