Prior to First Commercial Launch Sample Clauses

Prior to First Commercial Launch. Subject to the terms and conditions of this Agreement, including Section 4.4.3, prior to First Commercial Launch of the first Product, CLIENT shall order [***] of its requirements for Products from LONZA in accordance with the terms and conditions of this Agreement.
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Prior to First Commercial Launch. In the event that the Parties agree, or a Laboratory determines, pursuant to Section 6.5, that a Batch of Product manufactured prior to First Commercial Launch materially fails to conform to the Product Warranties due to the failure of: (a) LONZA personnel properly to execute the Master Production Record, (b) LONZA personnel to comply with cGMP, or (c) the Facility utilities, then, at CLIENT’s request, LONZA will at CLIENT’s election promptly produce for CLIENT sufficient quantities of Product to replace the non-conforming portion of such Batch of Product (the “Production Rerun”), in accordance with the provisions of this Agreement and at no additional cost to CLIENT (i.e., if CLIENT has first paid for the original Batch of Product, such replacement with conforming quantities shall be without charge, and LONZA will pay for shipment, duties and the like with respect to the replacement Products or if CLIENT has not yet paid for the original Batch of Product, CLIENT shall be obligated to pay for the replacement with conforming quantities in accordance with the terms of this Agreement); provided, however, that to the extent that the Parties agree, or a Laboratory determines, pursuant to Section 6.5, that a Batch of Product materially failed to conform to the Product Warranties for any reason other than as set forth in the preceding sentence, then LONZA shall have no liability to CLIENT with respect to such Batch and LONZA will, at CLIENT’s request, produce for CLIENT a Production Rerun at CLIENT’s expense. For the avoidance of doubt, any failure to conform that prevents the release of any one or more lots of Product, or that prevents the use of Product in clinical trials or the sale of Products for use in humans shall be deemed to constitute a circumstance in which such Product “materially fails to conform” to the Product Warranties.

Related to Prior to First Commercial Launch

  • Synchronization, Commissioning and Commercial Operation 4.1.1 The Power Producer shall give at least fifteen (15) days written notice to the SLDC / ALDC / DISCOM as the case may be, of the date on which it intends to synchronize the Power Project to the Grid System. 4.1.2 Subject to Article 4.1.1, the Power Project may be synchronized by the Power Producer to the Grid System when it meets all the connection conditions prescribed in the Grid Code and otherwise meets all other Indian legal requirements for synchronization to the Grid System. 4.1.3 The synchronization equipment and all necessary arrangements / equipment including Remote Terminal Unit (RTU) for scheduling of power generated from the Project and transmission of data to the concerned authority as per applicable regulation shall be installed by the Power Producer at its generation facility of the Power Project at its own cost. The Power Producer shall synchronize its system with the Grid System only after the approval of GETCO / SLDC / ALDC and GEDA. 4.1.4 The Power Producer shall immediately after each synchronization / tripping of generator, inform the sub-station of the Grid System to which the Power Project is electrically connected in accordance with applicable Grid Code. 4.1.5 The Power Producer shall commission the Project within SCOD. 4.1.6 The Power Producer shall be required to obtain Developer and/ or Transfer Permission, Key Plan drawing etc, if required, from GEDA. In cases of conversion of land from Agricultural to Non-Agriculture, the commissioning shall be taken up by GEDA only upon submission of N.A. permission by the Power Producer. 4.1.7 The Power Producer shall be required to follow the Forecasting and Scheduling procedures as per the Regulations issued by Hon’ble GERC from time to time. It is to clarify that in terms of GERC (Forecasting, Scheduling, Deviation Settlement and Related Matters of Solar and Wind Generation Sources) Regulations, 2019 the procedures for Forecasting, Scheduling & Deviation Settlment are applicable to all solar generators having combined installed capacity above 1 MW connected to the State Grid / Substation including those connected via pooling stations.

  • Commercial Operation Date 6.4.1 The SPV shall ensure that the Project Commercial Operation Date is achieved on or prior to the Scheduled Commercial Operation Date. The SPV shall provide a written notice to MSEDCL at least 30 (thirty) days in advance intimating MSEDCL of the proposed date on which the Commercial Operation Date of a Unit or the Project is proposed to be achieved. 6.4.2 If the Commercial Operation Date for the Units having a capacity equivalent to at least 75% (seventy five percent) of the Contracted Capacity is achieved before the Scheduled Commercial Operation Date, then all Units in respect of which the Commercial Operation Date has been achieved prior to the Scheduled Commercial Operation Date would be eligible for incentives as follows: (a) the Unit(s) injecting energy at 11 kV /22 kV shall be given an incentive of Rs. 0.25/ kWh; and (b) the Unit(s) injecting energy at 33 kV shall be given an incentive of Rs. 0.15/ kWh, for the power sold to MSEDCL for the first 3 (three) years from the Commercial Operation Date. To receive such incentives from MSAPL, which shall be over and above the Tariff, the SPV shall follow the process agreed to by the SPV under the Implementation Agreement. 6.4.3 It is hereby clarified that the aforementioned incentive shall not be available: (i) in respect of any Unit if the Commercial Operation Date for such Unit has not been achieved prior to the Scheduled Commercial Operation Date; and (ii) if the aggregate capacity of the Units for which the Commercial Operation Date has been achieved prior to Scheduled Commercial Operation Date is less than 75% (seventy five percent) of the Contracted Capacity. 6.4.4 In the event that Commercial Operation Date for any of the Units is achieved after the Scheduled Commercial Operation Date, the SPV shall be liable to pay Liquidated Damages as per the provisions set out below. 6.4.5 Without prejudice to any other rights of MSEDCL under this PPA, in case one or more Units of the SPV are unable to achieve Commercial Operation Date within a period of 2 (two) months from the Scheduled Commercial Operation Date, the capacity of such Units shall be annulled, and the Contracted Capacity shall be reduced to that extent. For Illustration: The Project has a Contracted Capacity of 100 MW and comprises of 10 Units of 10 MW each. If at the end of the aforementioned period of 14 (fourteen) months from the Effective Date, the SPV has achieved Commissioning for only 8 out of 10 Units, then the Contracted Capacity of the Project will stand reduced for the capacity of the 2 Units which have not been Commissioned, i.e. the Contracted Capacity will be 80 (100 (original Contracted Capacity)) – 10 (capacity of each Unit)*2 (number of Units not Commissioned).

  • Commercial Operation (i) On or before December 31, 2021, Interconnection Customer must demonstrate commercial operation of all generating units. Demonstrating commercial operation includes achieving Initial Operation in accordance with Section 1.4 of Appendix 2 to this ISA and making commercial sales or use of energy, as well as, if applicable, obtaining capacity qualification in accordance with the requirements of the Reliability Assurance Agreement Among Load Serving Entities in the PJM Region.

  • Development Phase contractual phase initiated with the approval of ANP for the Development Plan and which is extended during the Production Phase while investments in xxxxx, equipment, and facilities for the Production of Oil and Gas according to the Best Practices of the Oil Industry are required.

  • RESEARCH AND PUBLICATION 29 CONTRACTOR shall not utilize information and/or data received from COUNTY, or arising out 30 of, or developed, as a result of this Agreement for the purpose of personal or professional research, or 31 for publication. 32

  • Approval for Publishing The Author shall proofread the page proofs for the Contribution provided by or on behalf of the Publisher, including checking the illustrations as well as any media, social or functional enhancements and give approval for publishing, if and when requested by the Publisher. The Author’s approval for publishing is deemed to have been given if the Author does not respond within a reasonable period of time (as determined by the Publisher) after receiving the proofs nor contacts the Publisher within three days after receipt of the last of three reminders sent by the Publisher via email. The Publisher shall not be required to send a second set of corrected proofs unless specifically requested by the Author in writing but in any event no further amendments may be made or requested by the Author. In the event of co-authors having entered into this Agreement the Publisher shall send the page proofs to the Corresponding Author only and all persons entering into this Agreement as Author agree that the Corresponding Author shall correct and approve the page proofs on their behalf. If the Author makes changes other than correcting typographical errors, the Author shall bear all the Publisher's costs of such alterations to proofs including without limitation to alterations to pictorial illustrations. The Publisher shall have the right to charge and invoice these costs plus value added or similar taxes (if applicable) through its affiliated company Springer Nature Customer Service Center GmbH or Springer Nature Customer Service Center LLC, respectively, to the Author, payable within 14 days of receipt of the invoice.

  • Commercial Supply After the Option Termination Date: (a) if requested by Kolltan, the Parties shall undertake good faith negotiations regarding a commercial supply agreement pursuant to which MedImmune would supply to Kolltan, and Kolltan would purchase from MedImmune, quantities of the Licensed Antibody or Licensed Product, in any of its forms, for use by Kolltan, for commercial sale (“Commercial Supply Agreement”); and (b) if (i) for any reason the Parties have not entered into the Commercial Supply Agreement (including if Kolltan has not requested that the Parties undertake negotiations with respect to thereto pursuant to Section 3.6.4(a)) or (ii) the Commercial Supply Agreement is entered into by the Parties but expires or is terminated for any reason other than breach by Kolltan, without limitation of any other rights that may be available to Kolltan, upon Kolltan’s written request and subject to MedImmune’s good faith consent as described below, MedImmune shall (x) transfer and/or disclose to Kolltan or any Qualified Contract Manufacturer designated in good faith by Kolltan such MedImmune Manufacturing Know-How and (y) provide to Kolltan or such Qualified Contract Manufacturer such technical assistance, in each case ((x) and (y)) as reasonably required for Kolltan or such Qualified Contract Manufacturer to Manufacture the Licensed Antibody and Licensed Products for use in Kolltan’s Commercialization activities hereunder. The foregoing sentence notwithstanding, except as set forth in Section 3.6.5 below, MedImmune has no obligation to disclose to Kolltan or any Qualified Contract Manufacturer the MedImmune Manufacturing Know How related to MedImmune proprietary cell culture media and nutrient feeds used in the Manufacturing process. Kolltan acknowledges and agrees that any transfer and/or disclosure by Kolltan of any MedImmune Manufacturing Know-How described in the immediately preceding sentence to a Third Party shall require the prior written consent of MedImmune; provided, however, that (A) MedImmune shall not unreasonably withhold such consent and (B) MedImmune’s determination as to whether to provide such consent shall be made in good faith. The transfers and disclosures described in clause (x) above shall be made (1) in any manner or form reasonably requested by Kolltan and (2) at MedImmune’s expense; provided, however, if at Kolltan’s request any such transfer or disclosure is made in any manner or form that is not reasonably standard in the biopharmaceutical industry for transfers or disclosures of a similar kind, such transfer or disclosure shall be made at Kolltan’s expense. The assistance described in clause (y) above shall be provided at MedImmune’s expense, provided, however, that the scope of such assistance will be limited to reasonable and customary assistance related to technology transfer under similar circumstances in the biologics industry.

  • Technology Research Analyst Job# 1810 General Characteristics

  • Xxxxxxxx, President ACKNOWLEDGED AND ACCEPTED -------------------------

  • Xxxxxxx, President Xxxxx X.

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