Modifications to Equipment and Facility Sample Clauses

Modifications to Equipment and Facility. Oread shall notify Praecis of any significant modifications to parts of the Facility used for Processing, Packaging or storage to the extent such modifications impact or could reasonably be expected to impact the Product . Oread shall not implement any material changes relating to the Product (including modifications to equipment) without obtaining Praecis's prior written approval which approval shall not be unreasonably withheld. A material change is defined as any change that (a) impacts the regulatory commitments made to Regulatory Authorities for the Product; (b) may require re-validation; (c) may affect the quality, purity, identity or strength of the in-process or finished Product; or (d) could reasonably be expected to result in changing or modifying the Praecis or Oread Specifications, test methods, sampling procedures, standard operating procedures, or the Master Batch Record with respect to the Product. The parties to this Agreement shall agree in advance which party will pay for any expenses associated with any modifications and material changes made or proposed to be made under this provision of the Agreement.
Sample 1
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Modifications to Equipment and Facility. Duramed shall not modify any parts of the Duramed Facility used for Manufacturing, Packaging or storage of the Product if such modifications impact the DMF or otherwise affect the Product or the NDA, unless approved in advance in writing by Warner. Duramed shall not implement any material changes relating to the Product without obtaining Warner's prior written approval. A material change is defined as any change that (a) impacts the regulatory commitments made to Regulatory Authorities for the Product; (b) may require re-validation; (c) affects the quality, purity, identity or strength of the Raw Materials, Packaging Components or the finished Product; (d) is or may be reportable to the Regulatory Authorities; or (e) would necessarily result in changing or modifying the Specifications, test methods, sampling procedures, standard operating procedures, or the Master Batch Record with respect to the Product. Duramed shall pay for any expenses associated with any modifications and material changes initiated by Duramed.
Sample 1
Modifications to Equipment and Facility. Xxxxxx shall notify SuperGen of any modifications to parts of the Facility used for Processing or storage if such modifications impact or otherwise could reasonably be expected to affect the API or the Master Production Record. Xxxxxx shall not implement any Material Changes (as defined below) relating to the API without obtaining prior written approval from SuperGen, which approval shall not be unreasonably withheld. As used in this Section 9.4, a “Material Change” shall mean any change that (a) impacts the regulatory commitments made to Regulatory Authorities for the API; or (b) will require revalidation; or (c) could reasonably be expected to affect the quality, purity, identity, strength or yield of the in process or finished API; or (d) would necessarily result in changing or modifying the Specifications; or (e) constitutes a significant change to test methods, sampling procedures, Xxxxxx’x standard operating procedures or the Master Production Record; or (f) would require material modifications to the equipment used in the Facility. Xxxxxx shall pay for any expenses to the extent they are for any modifications and Material Changes made to the Facility initiated by Xxxxxx; such changes may not be the basis of any increase in the Processing Fee. SuperGen shall pay for any expenses to the extent they are for any modifications and material changes made to Processing the Deliverables, or if the changes are in excess of cGMP requirements initiated by SuperGen.
Sample 1

Related to Modifications to Equipment and Facility

  • Equipment and Facilities For On-Site Courses, you will supply the facility and equipment as set forth at xxx.xxxxxx.xxx/xxxxxxxx/xxxxxxxxx/xxxxxxxxxxxx.xxxx. If Red Hat agrees to provide the training facilities and hardware, you will be liable for any loss or destruction of this equipment and hardware used in connection with the Training.

  • Office Space, Equipment and Facilities Provide such office space, office equipment and office facilities as are adequate to fulfill the Adviser’s obligations hereunder.

  • Equipment and Tools 40.01 The Employer will make available all necessary tools and equipment it requires for the performance of work assignments at no cost to the employees. Such tools and equipment will remain the property of the Employer and the employees will be required to take reasonable care of this property and may be required to sign out certain equipment and tools.

  • All new supplies equipment and services shall include manufacturer's minimum standard warranty unless otherwise agreed to in writing. Vendor shall be legally permitted to sell all products offered for sale to TIPS Members. All goods proposed and sold shall be new unless clearly stated in writing. The Vendor shall provide timely and accurate customer support for orders to TIPS Members as agreed by the Parties. Vendors shall respond to such requests within a commercially reasonable time after receipt of the request. If support andƒor training is a line item sold or packaged with a sale, support shall be as agreed with the TIPS Member. Most TIPS Members are tax exempt and the related laws andƒor regulations of the controlling jurisdiction(s) of the TIPS Member shall apply. No assignment of Agreement may be made without the prior notification of TIPS. Written approval of TIPS shall not be unreasonably withheld. Payment for delivered goods and services can only be made to the awarded Vendor, Vendor designated reseller or vendor assigned company.

  • Equipment and Supplies Independent Contractor, at Independent Contractor's sole expense, shall provide all equipment, tools and supplies necessary to perform the Service.

  • Interconnection Facilities Engineering Procurement and Construction Interconnection Facilities, Network Upgrades, and Distribution Upgrades shall be studied, designed, and constructed pursuant to Good Utility Practice. Such studies, design and construction shall be based on the assumed accuracy and completeness of all technical information received by the Participating TO and the CAISO from the Interconnection Customer associated with interconnecting the Large Generating Facility.

  • Additional Equipment Additional Equipment may from time to time be added as the subject matter of this Agreement as agreed on by the parties. Any additional property will be added in an amendment describing the property, the monthly rental, security deposit, and stipulated loss value of the additional Equipment. All amendments must be in writing and signed by both parties. Other than by this amendment procedure, this Agreement may not be amended, modified, or altered in any manner except in writing signed by both parties.

  • Equipment and Software To use the Mobile Remote Deposit Services, you must obtain and maintain at your expense, compatible equipment and software that we may specify from time to time.

  • Early Construction of Base Case Facilities Developer may request Connecting Transmission Owner to construct, and Connecting Transmission Owner shall construct, subject to a binding cost allocation agreement reached in accordance with Attachment S to the ISO OATT, including Section 25.8.7 thereof, using Reasonable Efforts to accommodate Developer’s In-Service Date, all or any portion of any System Upgrade Facilities or System Deliverability Upgrades required for Developer to be interconnected to the New York State Transmission System which are included in the Base Case of the Class Year Study for the Developer, and which also are required to be constructed for another Developer, but where such construction is not scheduled to be completed in time to achieve Developer’s In-Service Date.

  • PURCHASE OF EQUIPMENT AND PERSONAL PROPERTY For valuable consideration, the sum of $1.00, receipt of which is acknowledged, Xxxxxx agrees to quitclaim, transfer, sell, waive and release any interest it has or may have, including as the beneficiary of any trust interest created by the provisions of The Book of Discipline of The United Methodist Church, and Xxxxx agrees to accept all of Seller’s title and interest, if any, in and to all of the properties and assets held by Xxxxxx United Methodist Church and relating to the Conference’s claim for itself, or on behalf of The United Methodist Church, of any beneficial right of any kind, including all proprietary rights and privileges of any kind or nature, whether arising by operation of law, trust, contract, property or other means to all tangible personal property owned as of the date of this Bill of Sale in the name of Xxxxxx United Methodist Church (including, without limitation, cash, bank accounts, accounts and notes receivable, deposits, prepaid items, contents, furnishings, equipment, tools, furniture, leasehold improvements, computer software, permits, licenses, authorizations, books, records, papers, securities, funds, goodwill, contracts, and other intangibles (hereinafter collectively, the "Personal Property") on the terms and conditions set forth in this Bill of Sale.

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