GMP operation Sample Clauses

GMP operation. The cost of the GMP operation as described here above and in the Esperion total and Esperion GMP Xxxxx chart will be BEF 29,250,000. This price excludes the raw materials and chromatographic media costs, those cost will not exceed USD 40,000. Those will be invoiced separately. Xxxxxx Xxxxx Xxxxxxxxxxxxxxxxx X0 (XxxX0 project) Esperion Therapeutics --------------------- Step Equipment Preculture Conical flask Fermentation (350L) : E coli Fermentor IF-500 (New Brunswick Cell concentration Continue centrifuge (Westfalia CSA119 Cell storage (-20(degrees)C) Freezer - 20(degrees)C Cell breakage DynoMil D20 (glass bead xxxxxx) Liquid/liquid extraction Nalgene tank Centrifugation Centrifuge (Xxxxxxx Avanti-J20) Filtration, 0,22 um ------------------------------------------------------------------------------------------------
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Related to GMP operation

  • Co-operation The Custodian shall cooperate with and supply necessary information to the entity or entities appointed by the Trust to keep the books of account of the Fund and/or compute the value of the assets of the Fund. The Custodian shall take all such reasonable actions as the Trust may from time to time request to enable the Trust to obtain, from year to year, favorable opinions from the Trust's independent accountants with respect to the Custodian's activities hereunder in connection with (a) the preparation of the Trust's reports on Form N-1A and Form N-SAR and any other reports required by the Securities and Exchange Commission, and (b) the fulfillment by the Trust of any other requirements of the Securities and Exchange Commission.

  • Profitable Operations Borrower will not permit Consolidated Net Income (a) for any fiscal year, commencing with the fiscal year ending December 31, 2002, to be less than $1.00 and (b) for any two consecutive fiscal quarters (treated as a single accounting period) to be less than $1.00.

  • Business Operations Company and Shareholders shall operate the Business and use the Assets in the ordinary course. Company and Shareholders shall not enter into any lease, contract, indebtedness, commitment, purchase or sale or acquire or dispose of any capital asset relating to the Business or the Assets except in the ordinary course of business. Company and Shareholders shall use their best efforts to preserve the Business and Assets intact and shall not take any action that would have an adverse effect on the Business or Assets. Company and Shareholders shall use their best efforts to preserve intact the relationships with payors, customers, suppliers, patients and others having significant business relations with Company. Company and Shareholders shall collect its receivables and pay its trade payables in the ordinary course of business. Company and Shareholdes shall not introduce any new method of management, operations or accounting.

  • Ongoing Operations From the Effective Date through Closing:

  • Interim Operations (a) The Company covenants and agrees as to itself and its Subsidiaries that, after the date hereof and prior to the Effective Time (unless Parent shall otherwise approve in writing (such approval not to be unreasonably withheld, delayed or conditioned)), and except as otherwise expressly permitted by this Agreement or as required by a Governmental Entity or applicable Laws, the business of it and its Subsidiaries shall be conducted in all material respects in the ordinary course and, to the extent consistent with the foregoing, the Company and its Subsidiaries shall use their respective commercially reasonable efforts to preserve their business organizations substantially intact, maintain satisfactory relationships with Governmental Entities, NERC, PJM, customers and suppliers having significant business dealings with them and keep available the services of their key employees; provided, however, that no action taken by the Company or its Subsidiaries with respect to matters specifically addressed by clauses (i)-(xx) of this Section 6.1(a) shall be deemed a breach of this sentence unless such action would constitute a breach of such other provision. In furtherance of the foregoing, from the date of this Agreement until the Effective Time, except (A) as otherwise expressly permitted by this Agreement, (B) as Parent may approve in writing (such approval not to be unreasonably withheld, delayed or conditioned), (C) as is required by applicable Law or any Governmental Entity or (D) as set forth in Section 6.1(a) of the Company Disclosure Letter, the Company will not and will not permit its Subsidiaries to:

  • Operating Plan To Agent and Lenders, as soon as available, but not later than thirty (30) days after the end of each Fiscal Year, an annual combined operating plan (the "Operating Plan") for Parent and its Subsidiaries, approved by the Board of Directors of Parent, for the following Fiscal Year, which (i) includes a statement of all of the material assumptions on which such plan is based, (ii) includes projected monthly income statement, balance sheets and source and use of funds for the following year and (iii) Borrowing Availability projections, all prepared on the same basis and in similar detail as that on which operating results are reported (and in the case of cash flow projections, representing management's good faith estimates of future financial performance based on historical performance), and including plans for personnel, Capital Expenditures and facilities.

  • Maintenance and Operation (a) Lessee, at its own cost and expense, shall maintain, repair and keep each Unit, and cause the Manager under the Management Agreement to maintain, repair and keep each Unit, (i) according to Prudent Industry Practice and in all material respects, in good working order, and in good physical condition for railcars of a similar age and usage, normal wear and tear excepted, (ii) in a manner in all material respects consistent with maintenance practices used by the Manager in respect of railcars owned, leased or managed by the Manager similar in type to such Unit or, with respect to (A) any Equipment subject to an Existing Equipment Sublease that is a Net Sublease, maintenance practices used by the applicable Sublessee in respect of railcars similar in type to such Unit used by such Sublessee on its domestic routes in the United States; (provided further, however that after the return to the Manager of any Unit which was subject to a Net Sublease immediately prior to such return, such Unit shall be maintained and repaired in all material respects in a manner consistent with maintenance practices used by the Manager in respect of railcars owned, leased or managed by the Manager similar in type to such Unit) and (B) any Permitted Sublease that is a Net Sublease entered into after the Closing Date where (x) the long term unsecured debt of the applicable Sublessee is rated at least BBB- by S&P and Baa3 by Xxxxx'x (or at least BBB- by S&P or Baa3 by Xxxxx'x if then rated by only one such rating agency) or similarly rated by any rating agency, (y) the applicable Sublessee is organized under the laws of the United States or any State thereof and (z) the applicable Sublessee is the owner or lessee of at least 250 railcars used primarily on domestic routes in the United States, maintenance practices used by such Sublessee in respect of railcars similar in type to such Unit, (iii) in accordance with all manufacturer's warranties in effect but only to the extent that the lack of compliance therewith would reasonably be expected to adversely affect the coverage thereunder and in accordance with all applicable provisions, if any, of insurance policies required to be maintained pursuant to Section 12 and (iv) in compliance in all material respects with any applicable laws and regulations from time to time in effect, including, without limitation, the Field Manual of the AAR, FRA rules and regulations and Interchange Rules as they apply to the maintenance and operation of the Units in interchange regardless of upon whom such applicable laws and regulations are nominally imposed; provided, however, that, so long as the Manager or, with respect to any Equipment subject to an Existing Equipment Sublease which is a Net Sublease, the applicable Sublessee, as applicable, is similarly contesting such law or regulation with respect to all other similar equipment owned or operated by Manager or, with respect to any Equipment subject to an Existing Equipment Sublease which is a Net Sublease, the applicable Sublessee, as applicable, Lessee (or such Sublessee) may, in good faith and by appropriate proceedings diligently conducted, contest the validity or application of any such standard, rule or regulation in any manner that does not (w) materially interfere with the use, possession, operation or return of any of the Units, (x) materially adversely affect the rights or interests of Lessor, Policy Provider or the Indenture Trustee in the Units or hereunder, (y) expose Lessor, Policy Provider or the Indenture Trustee to criminal sanctions or (z) violate any maintenance requirements contained in any insurance policy required to be maintained by the Lessee under this Lease or the Collateral Agency Agreement if such violation would reasonably be expected to adversely affect the coverage thereunder; provided further, that Lessee shall promptly notify Lessor, Policy Provider and Indenture Trustee in reasonable detail of any such contest. In no event shall Lessee discriminate in any material respect as to the use or maintenance of any Unit (including the periodicity of maintenance or recordkeeping in respect of such Unit) as compared to equipment of a similar nature which the Manager owns or manages. Lessee will maintain all records, logs and other materials required by relevant industry standards or any governmental authority having jurisdiction over the Units required to be maintained in respect of any Unit, all as if Lessee were the owner of such Units, regardless of whether any such requirements, by their terms, are nominally imposed on Lessee, Lessor or Owner Participant.

  • Operational Control THE PARTIES EXPRESSLY AGREE THAT LESSEE SHALL AT ALL TIMES WHILE THE AIRCRAFT IS IN ITS POSSESSION DURING THE TERM MAINTAIN OPERATIONAL CONTROL OF THE AIRCRAFT, AND THAT THE INTENT OF THE PARTIES IS THAT THIS AGREEMENT CONSTITUTE A “DRY” OPERATING LEASE. Lessee shall exercise exclusive authority over initiating, conducting, or terminating any flight conducted pursuant to this Agreement, and the Flight Crew shall be under the exclusive command and control of Lessee in all phases of such flights.

  • Use and Operation You may enter upon my premises and take possession of all or any part of my property for the purpose of preserving the Property or its value, so long as you do not breach the peace. You may use and operate my property for the length of time you feel is necessary to protect your interest, all without payment or compensation to me.

  • Oil and Gas Operations (a) All wxxxx included in the Oil and Gas Interests of the Company have been drilled and (if completed) completed, operated and produced in accordance with generally accepted oil and gas field practices and in compliance in all respects with applicable oil and gas leases and applicable laws, rules and regulations, except where any failure or violation could not reasonably be expected to have a Material Adverse Effect on the Company; and

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