Performance Indicators means the indicators for Project monitoring and evaluation set forth in the Operational Manual.
Performance Indicator means a measure of HSP performance for which a Performance Target is set; technical specifications of specific Performance Indicators can be found in the MSAA Indicator Technical Specifications document;
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Commercialization Plan has the meaning set forth in Section 6.2.
Therapeutically equivalent drug products means drug products that contain the same active ingredients and are identical in strength or concentration, dosage form, and route of administration and that are classified as being therapeutically equivalent by the U.S. Food and Drug Administration pursuant to the definition of "therapeutically equivalent drug products" set forth in the most recent edition of the Approved Drug Products with Therapeutic Equivalence Evaluations, otherwise known as the "Orange Book."
Development Milestone is defined in Section 5.3.
Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.
Development Schedule shall have the meaning set forth in Section 1.1.
Major Market Countries means the United States, Japan, England, Germany, France, Italy and Spain.
Development Milestone Payment shall have the meaning set forth in Section 9.2(a).
Annual Net Sales means, with respect to any Calendar Year, the aggregate amount of the Net Sales for such Calendar Year.
Development Milestone Event has the meaning set forth in Section 7.2.1.
Development Plan has the meaning set forth in Section 3.2.
Combination Products means COBI Combination Products, EVG Combination Products, TDF Combination Products, TAF Combination Products and Quad Product.
New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.
Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;
Research Period means the research period as described in the Commissioned Research Plan. In accordance with the provisions of this Agreement, in the event that the Agreement ended prior to the completion date of the research originally set, the date the Agreement ends shall be read as the research period.
Combination Product means any combination of the Product with one (1) or more other active ingredients, products or services that is not the Product, where such products are sold either as a fixed dose/unit or as separate doses/units in a single package for a single price.
U.S. Territory means American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, or the U.S. Virgin Islands.
Research Plan shall have the meaning set forth in Section 2.1.
Collaboration Term has the meaning set forth in Section 2.1(h).
Development Program means the implementation of the development plan.
Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.
Research Budget has the meaning set forth in Section 2.2.
Additional Indication means any indication other than the Initial Indication.
Nondesignated country end product means any end product that is not a U.S.-made end product or a designated country end product.