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.
Launch Date has the meaning specified therefor in Section 2.02(b) of this Agreement.
Commercial Launch means the initial First Commercial Sale of a Product in the Territory.
Launch means the intentional ignition of the first-stage motor(s) of the Launch Vehicle intended to place or try to place a Launch Vehicle (which may or may not include any Transfer Vehicle, Payload or crew) from Earth:
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.
Product Schedule means PTC’s standard order form entitled “PTC Product Schedule” (including all schedules, attachments and other document(s) specifically referenced therein) or such alternative order form as may be submitted by Customer and accepted by PTC, in each case that specifies (i) the Licensed Products and/or Services ordered; and (ii) for Licensed Products, the installation address (including the Designated Country) and the Licence Term.
Collaboration Term has the meaning set forth in Section 2.1(h).
Program Period means the period of time which the department intends to support the program without requiring the recompetition for funds. The program period is specified within the grant application.
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 Plan has the meaning set forth in Section 3.2.
Contract Year means each period of twelve (12) consecutive months during the Initial Term of this Agreement, with the first Contract Year commencing on the Effective Date, and with each subsequent Contract Year commencing on the anniversary of the Effective Date.
Regulatory Exclusivity Period means, with respect to each Licensed Product in any country in the Territory, a period of exclusivity (other than Patent exclusivity) granted or afforded by Applicable Law or by a Regulatory Authority in such country which confers an exclusive Commercialization period during which AbbVie or its Affiliates or Sublicensees have the exclusive right to market and sell a Licensed Compound or Licensed Product in such country through a regulatory exclusivity right.
License Period means the period beginning from the Commencement Date and ending on the Termination Date.
Licensed Program means the executable processing programs of licensed information, which is composed of various modules in the Licensed Software package provided by the Licensor.
Licensed Product means a product, method or service in the Licensed Field of Use, the making, having made, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent.
Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.
Major Market Country means one or more of the following: Canada, France, Germany, Italy, Japan, Spain, Switzerland, United Kingdom, and United States of America.
Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.
Commercialization Plan has the meaning set forth in Section 6.2.
Research Program Term has the meaning set forth in Section 2.2.
Supply Period means for a Supply Point, the period beginning on the Start Date and ending on the Termination Date;
Promotion Period means the period the Promotion is open, as specified in clause 5.1.
First Indication means the first disease condition for which a particular Licensed Product has been approved by a Regulatory Authority.
Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
Marketing Period means the first period of twenty (20) consecutive days after the date of this Agreement throughout and on the last day of which (a) Buyers shall have received all of the Required Information and such Required Information is Compliant (provided, that if the Company shall in good faith reasonably believe it has provided the Required Information and that the Marketing Period has commenced, it may deliver to Buyers a written notice to that effect (stating when it believes it completed such delivery), in which case the Marketing Period will be deemed to have commenced on the date of such notice unless Buyers in good faith reasonably believes the Marketing Period has not commenced and within two Business Days after the delivery of such notice by the Company, delivers a written notice to the Company to that effect (setting forth with specificity why they believe the Marketing Period has not commenced)), and (b) the conditions set forth in Article VII shall be satisfied or waived (other than the condition set forth in Sections 7.01(e) and 7.01(j) and other those that by their nature need not be satisfied until the Closing or are to be performed at Closing, but subject to the satisfaction or waiver of those conditions at such time); provided, that the Marketing Period shall not be deemed to have commenced if at any time during such twenty (20) consecutive day period (i) the applicable independent auditors of the Company shall have withdrawn any audit opinion contained in the Required Information, (ii) any Required Information ceases to be Compliant or (iii) the Company or its independent auditors determines that the Company must restate any historical financial statements or material financial information included in the Required Information (each of the conditions set forth in clauses (i) through (iii) above being referred to as a “Marketing Period Delay Condition”), then, in each case, the Marketing Period shall not be deemed to have commenced until the date on which such Marketing Period Delay Condition is cured, subject, in each case, to the conditions set forth in clauses (a) and (b) and clauses (i) through (iii) above (which may result in a subsequent Marketing Period Delay Condition). Notwithstanding anything to the contrary in this definition, (A) the Marketing Period shall not include any date from and including November 27, 2014 through and including November 28, 2014, and if such Marketing Period has not ended prior to December 19, 2014, such Marketing Period will not begin until January 5, 2015, (B) if the Required Information is Compliant and any of the Company’s applicable current or former independent accountants declines to issue customary comfort letters (including as to customary negative assurance comfort and change period) with respect to any Required Information, the Marketing Period shall end no earlier than five (5) days after all applicable independent accountants have issued such comfort letters, and (C) the Marketing Period shall terminate on the date on which the Debt Financing or the related financings described in the Debt Commitment Letters required to consummate the transactions contemplated hereby is consummated if such date is earlier than the last day of the twenty (20) consecutive day period described above (including any required extensions, as provided above).
Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).