cGMP Preparation Sample Clauses

cGMP Preparation. (1) Avecia shall carry out cGMP preparation work following the decision that Avecia shall carry out the Validation Campaign under and in accordance with Clause 2.3(e) above. Such cGMP preparation work shall include the work identified in the Work Programme, the Quality Agreement and any additional work agreed under a Program Amendment Order pursuant to Clause 2.3(c)(2) or otherwise. (2) Avecia shall produce a Validation Master Plan for review, comment and approval by Nuvelo before the start of the Validation Campaign. (3) Avecia shall conduct the Validation Campaign in accordance with the terms and conditions of this Agreement and the Quality Agreement. The Quality Agreement sets forth how the Parties’ Quality Units will jointly review non-conformances, determine severity, assess their level of impact on the API and agree on actions which may include accepting a Validation Batch, failing a Validation Batch or declaring a Validation Batch to be a Defective Batch, disqualifying a Validation Batch from the series of three (3) consecutive Batches or passing or failing the entire Validation Campaign.
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Related to cGMP Preparation

  • Joint Preparation The preparation of this Agreement has been a joint effort of the parties and the resulting documents shall not, solely as a matter of judicial construction, be construed more severely against one of the parties than the other.

  • Surface Preparation Clean the surface to be treated of all dust, dirt, clay, grass, sod and any other deleterious matter before application of the asphalt surface treatment.

  • Site Preparation Axon will provide a hardcopy or digital copy of current user documentation for the Axon Devices ("User Documentation"). User Documentation will include all required environmental specifications for the professional services and Axon Devices to operate per the Axon Device User Documentation. Before installation of Axon Devices (whether performed by Customer or Axon), Customer must prepare the location(s) where Axon Devices are to be installed ("Installation Site") per the environmental specifications in the Axon Device User Documentation. Following installation, Customer must maintain the Installation Site per the environmental specifications. If Axon modifies Axon Device User Documentation for any Axon Devices under this Agreement, Axon will provide the update to Customer when Axon generally releases it

  • Proposal Preparation The contractor shall assume all costs associated with preparation of proposals for task order awards under the proposal process as an indirect charge (B&P costs). The Government will not reimburse awardees for proposals as a direct charge.

  • DOCUMENT PREPARATION The Transfer/Deed shall, save for the Land Transfer Tax Affidavit, be prepared in registrable form at the expense of Seller, and any Charge/Mortgage to be given back by the Buyer to Seller at the expense of the Buyer. If requested by Buyer, Seller covenants that the Transfer/Deed to be delivered on completion shall contain the statements contemplated by Section 50(22) of the Planning Act, R.S.O.1990.

  • Preparation Awarded vendor shall not begin a project for which TIPS Member has not prepared the site, unless awarded vendor does the preparation work at no cost, or until TIPS Member includes the cost of site preparation in a purchase order. Site preparation includes, but is not limited to: moving furniture, installing wiring for networks or power, and similar pre-installation requirements. Registered sex offender restrictions: For work to be performed at schools, awarded vendor agrees that no employee of a sub-contractor who has been adjudicated to be a registered sex offender will perform work at any time when students are, or reasonably expected to be, present. Awarded vendor agrees that a violation of this condition shall be considered a material breach and may result in the cancellation of the purchase order at the TIPS Member’s discretion. Awarded vendor must identify any additional costs associated with compliance of this term. If no costs are specified, compliance with this term will be provided at no additional charge. Safety measures: Awarded vendor shall take all reasonable precautions for the safety of employees on the worksite, and shall erect and properly maintain all necessary safeguards for protection of workers and the public. Awarded vendor shall post warning signs against all hazards created by the operation and work in progress. Proper precautions shall be taken pursuant to state law and standard practices to protect workers, general public and existing structures from injury or damage.

  • Costs of negotiation, preparation etc The Borrowers shall pay to the Agent on its demand the amount of all expenses incurred by the Agent or the Security Trustee in connection with the negotiation, preparation, execution or registration of any Finance Document or any related document or with any transaction contemplated by a Finance Document or a related document.

  • Preparation and Submission The Recipient will: (a) submit to the Province at the address referred to in section A17.1, all Reports in accordance with the timelines and content requirements as provided for in Schedule “F”, or in a form as specified by the Province from time to time; (b) submit to the Province at the address referred to in section A17.1, any other reports as may be requested by the Province in accordance with the timelines and content requirements specified by the Province; (c) ensure that all Reports and other reports are completed to the satisfaction of the Province; and (d) ensure that all Reports and other reports are signed on behalf of the Recipient by an authorized signing officer.

  • Preparation; Reasonable Investigation In connection with the ------------------------------------- preparation and filing of each registration statement under the Securities Act pursuant to this Agreement, the Company will give the holders of Registrable Securities registered under such registration statement, their underwriters, if any, and their respective counsel and accountants, the opportunity to participate in the preparation of such registration statement, each prospectus included therein or filed with the Commission, and each amendment thereof or supplement thereto, and will give each of them such access to its books and records and such opportunities to discuss the business of the Company with its officers and the independent public accountants who have certified its financial statements as shall be necessary, in the opinion of such holders' and such underwriters' respective counsel, to conduct a reasonable investigation within the meaning of the Securities Act.

  • Preparation Periods 31-1 The School District agrees to maintain daily preparation periods during the student day in all junior and senior high schools. At schools where block scheduling is in effect, the total preparation time provided shall be equal to the preparation time provided at schools not operating on a block schedule. 31-2 The School District shall maintain at each elementary school a minimum of two hundred and fifty (250) minutes preparation time per week per teacher, during the students’ instructional day, in not less than forty- (40) minute blocks. Each elementary school shall be allocated and assigned library aide hours per school day in accordance with the following schedule: This aide time is provided in addition to the assigned media clerk time. Library aide time is guaranteed for the school year once set on a school year basis. There will be no changes in library aide time allocated due to fluctuation in enrollment. This provision for allocating library aide time will only remain as part of this Agreement if librarians are used to provide preparation time to elementary teachers. 31-3 Preparation time provided for in this Article shall be utilized by teachers in a manner which enables further development and refinement of professional skills and for instructional effectiveness. 31-4 Although it does not relate to any mandatory subject of bargaining, the School District states that it is its aim and objective to establish a maximum class load of thirty (30) students in grades 4, 5, and 6. 00-0 Xxx Xxxxxxxx may direct use of teacher preparation periods if such directed use is infrequent, advance notice is given and the District’s use of the teacher’s preparation period must not consume an entire period.

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