Initial Manufacturing Period definition

Initial Manufacturing Period has the meaning specified in Section 5.1(b);
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Initial Manufacturing Period means, (A) with respect to a Licensed Compound, the period beginning on the Effective Date and ending on the date of First Chain API Validation or, (B) with respect to a Product, the period beginning on the Effective Date and ending on the date of First Chain Finished Product Validation.
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Initial Manufacturing Period will have the meaning ascribed thereto in section 5.2(a);
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Examples of Initial Manufacturing Period in a sentence

  • Before and during the Initial Manufacturing Period, and thereafter on a rolling basis during the term of this Agreement, Client will issue an updated 18 month forecast on or before the 10th day of each month.

  • Beginning with Initial Manufacturing Period defined in subsection (b) below, this forecast will then be updated by Client on or before the *** on a rolling forward basis.

  • Before and during the Initial Manufacturing Period, and on a rolling basis during the term of this Agreement, Client will issue an updated […***…] forecast on or before […***…].

  • Before and during the Initial Manufacturing Period, and on a rolling basis during the term of this Agreement, Client will issue an updated *** forecast on or before the *** day of each month.

  • However, if, during the Initial Manufacturing Period, Patheon is unable to deliver the quantity of Product ordered under a Firm Order, within [**] Business Days after the scheduled Delivery Date (a “Late Initial Delivery Date”), Penwest will receive a credit from Patheon for the Initial Late Delivery that will be applied against the purchase price under Penwest’s next Firm Order.

  • Until Second Chain API Validation with respect to a Licensed Compound, the supply chain managed and overseen by Pharmacyclics (in cooperation with JBI during the Initial Manufacturing Period) shall be used to Manufacture API of such Licensed Compound for Clinical Supply (and, if applicable, for Commercial Supply).

  • Before and during the Initial Manufacturing Period, and on a rolling basis during the term of the Product Agreement, Client will issue an updated […***…] month forecast on Master Manufacturing Services Agreement or before the […***…] day of each month.

  • Before and during the Initial Manufacturing Period, and on a rolling basis during the term of the Product Agreement, Client will issue an updated […***…] month forecast on ***Confidential Treatment Requested Master Manufacturing Services Agreement or before the […***…] day of each month.

  • Pharmacyclics shall use Diligent Efforts to conduct (or have conducted) the Validation of the applicable Manufacturing processes in accordance with the GDP, subject to participation and involvement of JBI during the Initial Manufacturing Period as provided in Section 6.1.2(d).

  • Before and during the Initial Manufacturing Period, and on a rolling basis during the term of the Product Agreement, Client will issue an updated […***…] month forecast on or before the […***…] day of each month.


More Definitions of Initial Manufacturing Period

Initial Manufacturing Period has the meaning set forth in Section 6.1.1 (Arrowhead Manufacturing Activities).
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Related to Initial Manufacturing Period

  • 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).

  • Tobacco product manufacturer means an entity that after the date of enactment of this act directly (and not exclusively through any affiliate) meets 1 or more of the following:

  • Manufacturing Process means any process for—

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Supply Start Date means the date(s) specified in clause 2.8;

  • Supply Period means for a Supply Point, the period beginning on the Start Date and ending on the Termination Date;

  • Manufacturing Site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Clinical laboratory means a facility for the microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Net metering period means the 12-month period following the date of final interconnection of the

  • Product Manufacturer means the entity that assembles the component parts to manufacture the final Product;

  • Commissioning Period means, with respect to each Subproject, the period commencing upon the first delivery of Feed Gas to the Subproject in accordance with Sections 4.8 and 11.1 of the Agreement continuing through achievement of RFSU, commissioning, Start Up, Performance Testing and achievement of Substantial Completion for such Subproject.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Development Period means the period from the date of this Agreement until the Appointed Date;

  • API means American Petroleum Institute.

  • Current Good Manufacturing Practices or “cGMP” means applicable Good Manufacturing Practices as specified in the United States Code of Federal Regulations and/or the EU Good Manufacturing Guidelines, and any successor legislation from time to time, prevailing at the time of the manufacture of the Product.

  • Promotion Period means the period the Promotion is open, as specified in clause 5.1.

  • 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)).

  • Monitoring Period means the period from the Launch Date to the Valuation Date (both dates including) at such point in time at which the Reference Price of the Underlying is determined and published..