MANUFACTURING AND PACKAGING Sample Clauses

MANUFACTURING AND PACKAGING. The authorised distributor agrees to : a. The Vendor agrees to supply the approved products, manufactured/imported under the same Manufacturing/Import License, as provided in the technical documents submitted online in respect of the aforesaid tender. Deviation from that will lead to execution of penal b. Packing of drug items should be done as per provision laid down in Drug & Xxxxxxxx Xxx, 0000, and Rules framed thereunder i. The primary packing should strictly be made as per accounting unit prescribed. ii. The secondary packing should also be as per pack size prescribed. The idea of prescribing the norms of secondary packing is to issue the item to the periphery units in a sealed condition. However, the appropriate secondary packing can be determined in consultation with the selected vendor. iii. Sterile items are to be transported in such packaging so that there is no damage to the primary packaging during the transportation process. iv. All glass bottles should be new neutral glass. v. All plastic containers should be made of virgin grade plastics. vi. All plastic Jars above 450 Gms / ml should carry an inner plastic lid. vii. Packing of all supplied materials should be done with standard packing materials so as to ensure the material supplied remains undamaged during transportation and storage. This specially applies to items which are required to be sterile at the time of usage. viii. Corrugated package box size should be limited to : (12'' H x 24"L x 24"W). No corrugated box with contents should generally weigh more than 15 kgs (7 kgs in case of packages containing glassware and fragile materials). Items weighing more shall be packed so that safety of the material and handlers remains ensured.The inner lining shall be not less than 120 gsm and outer lining of the carton shall not be less than 150 gsm.Thenon glass xxxx containing cartons shall be of at least 5 ply with bursting strength not less than 9 kg/sqcmGlass xxxx containing cartons shall be of at least 7 ply with bursting strength not less than 12 kg/xxxx.Xx box should contain mixed products or mixed batches of the same product. The product label on the cartoon should be large at least 15cms x 10cms dimension. It should carry the correct technical name, date of manufacturing, date of expiry, quantity packed, storage & handling requirements, Hospital Supply - Not For Sale logo and net weight of the box.
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MANUFACTURING AND PACKAGING. 3.1 VGN will be responsible for the manufacture, packaging and release for sale of the Product in accordance with the marketing authorization and its prevailing Standard Operating Procedures (SOPs). 3.2 VGN will supply to SOI Product meeting the approved specifications.
MANUFACTURING AND PACKAGING. 8.1. Elan will be responsible for preparing and maintaining production and quality control documentation as outlined in the DMF. 8.2. Elan will provide Jazz Pharmaceuticals access to the master Batch records for review on site. 8.3. Elan will notify Jazz Pharmaceuticals in writing of any changes to the Master batch record outside the validated process and parameters filed in the Elan DMF. 8.4. Elan will assign a unique identifier (Batch number) for each unit operation of the Product manufactured per Elan SOPs. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24B-2 of the Securities Exchange Act of 1934, as amended.
MANUFACTURING AND PACKAGING. A. IMCOR will enter into a supply agreement for Imagent with KYOSEI. Product will be manufactured and supplied under cGMP guidelines. Labeling and packaging responsibilities will be negotiated in the Supply Agreement. The definitive Supply Agreement will be negotiated between the parties a time to be determined in the discretion of Kyosei, but no later than the initiation of Phase 3 clinical trials subject to the following terms: B. The right to transfer manufacturing to KYOSEI will be negotiated in the future. KYOSEI will give IMCOR written notification 6 months in advance of its desire to manufacture in the Territory. Transfer fees, costs of technical transfer, and cost of goods after transfer will be negotiated in good faith by both parties during the 6-month period. C. Upon reasonable prior notice to IMCOR, KYOSEI and its consultants shall have access to all books and records relating to the manufacture and supply of Imagent by IMCOR and its sublicensees to conduct a review or audit thereof. Such access shall be available not more than once each year, during normal business hours, and for five years after the expiration or termination of this Agreement. D. Upon approval by MHLW in the Territory, KYOSEI will pay IMCOR an amount equal to [****] of the Yakka Price of Licensed Product(s) for commercial shipments. IMCOR and KYOSEI agree to negotiate the transfer cost, if the cost of Imagent exceeds an acceptable transfer price in the future to include any changes in currency exchange rates. E. KYOSEI will supply IMCOR a written purchase order for a 6-month demand forecast for Imagent. The first 3 months of the Demand forecast will be considered by IMCOR as a firm order. KYOSEI may adjust the second 3 months of the demand forecast with 60 days written notice. F. IMCOR will notify KYOSEI of any change to manufacturing site, raw materials, packaging materials, or processes to the Product. G. The Supply Agreement will provide for the ability of IMCOR to continue to provide Product to KYOSEI following the termination of this agreement.
MANUFACTURING AND PACKAGING. 10.1. Patheon will create, control, issue and execute the master batch record. The Master Batch Record (original) used in the manufacture/ packaging of the Product will be submitted to Jazz Pharmaceuticals QA for approval prior to issuance for production. 10.2. Patheon will assign a unique identifier (batch number) for each unit operation of the Product manufactured per Patheon SOPs. 10.3. Patheon will calculate the expiration date for each batch of Product by adding the expiration period supplied by Jazz Pharmaceuticals to the date of Manufacture of each batch. 10.4. Patheon will only use approved API and Raw materials for the manufacture and packaging of the Product. [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED. 10.5. Patheon will pull and retain a reserve sample (twice the quantity required to perform all test per Specifications) that is representative of each batch of drug Product manufactured/packaged and stored with accordance to cGMPs. 10.6. Patheon will be responsible for the accuracy, completeness and maintenance of batch records used in the manufacturing and packaging processes. 10.7. Upon request, Patheon will provide Jazz Pharmaceuticals with copies of fully executed batch production and control records, laboratory testing records and any other associated documentation related to the manufacturing, packaging, testing and release of the Product. 10.8. Patheon will not rework or reprocess a batch or intermediate that does not conform to standards or specifications without prior written consent and approval from Jazz Pharmaceuticals.
MANUFACTURING AND PACKAGING. 6.1 The parties agree that all Licensed Products shall only be manufactured by an Approved Manufacturer. (a) The parties agree that IBC shall have no obligation to deliver the Formulation to an Approved Manufacturer unless and until such Approved Manufacturer has entered into a confidentiality agreement with IBC, to the satisfaction of IBC, that prohibits such Approved Manufacturer from revealing any proprietary and confidential information relating to the Formulation to any third parties, including Empyrean and IBC-Empyrean, L.L.C. IBC covenants and agrees that, upon execution of the confidentiality agreement, it shall provide each Approved Manufacturer with the Formulation, and appropriate written documentation of the Formulation, sufficient to permit the Approved Manufacturer to make and manufacture the Licensed Products. Empyrean agrees and acknowledges it has no right to obtain access to the confidential and proprietary information included in the Formulation. (b) Notwithstanding Section 6.2 (a) above, IBC represents and warrants that the complete Formulation, when available but within six months of executing this Agreement, will be placed in escrow at the law offices of Holtzman, Xxxxxxxx, Xxxxxx xxx Xxxxx. XXX xxxxxxr xxxxxx that, xxxwithstanding Section 6.2 (a) above, in the event IBC fails or otherwise refuses to deliver, upon execution of the confidentiality agreement, the complete Formulation to any Approved Manufacturer, then in such event, the board of managers of IBC-Empyrean, L.L.C. may direct that the Formulation be released from escrow and delivered to such an Approved Manufacturer. An escrow agreement setting forth this obligation and authorizing Holtzman, Krinzman, Equels and Furia to release thx Xxxmulation to an Approved Manufacturer shall be signed by the parties within thirty (30) days after the date of this Agreement. 6.3 The parties agree that all Licensed Products shall only be packaged by an Approved Packager.
MANUFACTURING AND PACKAGING a) Gum Tech shall manufacture the Products of commercially acceptable quality and in accordance with [Good Manufacturing Practices and] the Specifications. Gum Tech may, with the prior written consent of Customer and without limiting Gum Tech's obligations under this Agreement, subcontract the manufacturing process to an affiliate or a third party. Gum Tech shall supply raw materials for the Product in accordance with the standards prescribed by Customer. b) Should Gum Tech have to acquire any tools and/or machinery to be able to manufacture the Products then Gum Tech shall present to Customer a list of the required equipment with a specification of the cost thereof. Customer shall, after approval of the equipment and cost, pay for the equipment within 30 days after receipt of invoice. Such equipment shall become and remain the property of Customer. c) Customer shall have the right to inspect the production of the Products at Gum Tech's facilities during normal business hours together with representatives of Gum Tech. d) Upon the request of Customer, Gum Tech shall package the Products in compliance with the packaging and labeling instructions in the Specifications. Gum Tech may, with the prior written consent of Customer and without limiting Gum Tech's obligations under this Agreement, subcontract the packaging process to an affiliate or a third party. Gum Tech shall supply packaging materials for the Product printed with artwork provided by Customer. Gum Tech and Customer shall jointly agree on the volumes of packaging material to be purchased and stored by Gum Tech at any given time. Should Gum Tech become unable to use its stock of packaging material due to Customer's changes of the packaging design or discontinuance of any Products then Customer shall have the obligation to repurchase Gum Tech's stock of packaging material at cost. Gum Tech shall be responsible for checking the wet-proof to ensure that the packaging material is within the parameters proscribed by Customer and that it matches the artwork provided by Customer.
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MANUFACTURING AND PACKAGING 

Related to MANUFACTURING AND PACKAGING

  • Manufacturing and Supply (a) Depomed shall supply Product for use in conducting Depomed’s development activities for Product in the Field and in the Territory as set forth in Exhibit D. (b) During the four-year period beginning on the Effective Date (the “Supply Period”), Depomed shall supply and package (or have supplied and packaged) Product pursuant to this Section 4.8. Depomed will use commercially reasonable efforts to enter into a long-term Product supply agreement with [***] days after the Effective Date (the “Depomed Supply Agreement”) that will be freely assignable to Solvay or its Affiliates, successors or assigns at any time. In addition, Depomed and Solvay will negotiate and enter into a Product supply agreement with business terms substantially similar to the Depomed Supply Agreement concurrently with the execution and delivery by Depomed and [***] of the Depomed Supply Agreement (the “Solvay Supply Agreement”, and, together with the Depomed Supply Agreement, the “Supply Agreements”). The Supply Agreements will, together, contain the following provisions (among others mutually agreeable to the Parties): (i) Under the Solvay Supply Agreement, Depomed will agree to supply Solvay with its requirements of finished, packaged Product during the Supply Period; (ii) All manufacturing and records will be performed and maintained in accordance with specifications, cGMP and Applicable Law; (iii) Depomed will provide reasonable assistance to Solvay in the event Solvay wishes to qualify a backup Product manufacturer; (iv) Depomed shall [***]; (v) Solvay will pay Depomed the following amounts in connection with all activities performed by or on behalf of Depomed associated with Product manufacture and supply (other than activities specified on Exhibit D) (A) [***]% of Depomed’s out-of-pocket costs incurred in connection with such manufacture and supply of Product to Solvay, and (B) a labor charge equal to the FTE Charges for all Depomed employees allocated to the manufacture and supply of Product to Solvay, not to exceed FTE Charges for an aggregate of [***] during any given calendar quarter (and Depomed shall provide to Solvay periodic reports detailing the FTE Charges for which Solvay must pay Depomed hereunder);

  • Manufacturing and Marketing Rights The Company has not granted rights to manufacture, produce, assemble, license, market, or sell its products to any other person and is not bound by any agreement that affects the Company's exclusive right to develop, manufacture, assemble, distribute, market, or sell its products.

  • Packaging and Labeling Seller shall properly xxxx, xxxx, and ship Goods and provide Buyer with shipment documentation showing the Order number, Seller’s identification number for the subject Goods, the quantity of goods in shipment and the number of cartons or containers in the shipment.

  • Manufacturing (a) The Supplier shall without limitation be responsible, at no additional cost to the Purchaser, for: sourcing and procuring all raw materials for the Products; obtaining all necessary approvals, permits and licenses for the manufacturing of the Products; providing sufficient qualified staff and workers to perform the obligations under this Purchase Agreement; implementing and maintaining effective inventory and production control procedures with respect to the Products; and handling other matters as reasonably requested by the Purchaser from time to time. (b) The Supplier shall not change any process, material, component, packaging or manufacturing location without the Purchaser’s express prior written approval.

  • Manufacturing Technology Transfer Upon AbbVie’s written request with respect to a given Collaboration CAR-T Product and Licensed Product, Caribou shall effect a full transfer to AbbVie or its designee (which designee may be an Affiliate or a Third Party Provider) of all Materials and Know-How Controlled by Caribou relating to the then-current process for the Manufacture of such Collaboration CAR-T Product and any corresponding Licensed Products (each, a “Manufacturing Process”). Caribou shall provide, shall cause its Affiliates to provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to provide, all reasonable assistance requested by AbbVie to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to implement each Manufacturing Process at the facilities designated by AbbVie. If requested by AbbVie, such assistance shall include facilitating the entering into of agreements with applicable Third Party suppliers relating to such Collaboration CAR-T Product and any corresponding Licensed Products. Without limitation of the foregoing, in connection with the Manufacturing Process and related transfer: (a) Caribou shall, and shall cause its Affiliates to, make available to AbbVie (or its Affiliate or designated Third Party Provider, as applicable), and shall use Commercially Reasonable Efforts to assist AbbVie in causing all Third Party Providers to make available to AbbVie, from time to time as AbbVie may request, all Materials and Manufacturing-related Know-How Controlled by Caribou relating to each Manufacturing Process, including methods, reagents and processes and testing/characterization Know-How, and all documentation constituting material support, performance advice, shop practice, standard operating procedures, specifications as to Materials to be used, and control methods, that are necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party manufacturer, as applicable) to use and practice such Manufacturing Process; (b) Caribou shall cause all appropriate employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility at mutually convenient times to assist with the working up and use of each Manufacturing Process and with the training of the personnel of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to the extent necessary or reasonably useful to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice such Manufacturing Process; (c) Without limiting the generality of this Section 4.4.2, Caribou shall cause all appropriate analytical and quality control laboratory employees and representatives of Caribou and its Affiliates, and shall use Commercially Reasonable Efforts to assist AbbVie in causing all appropriate analytical and quality control laboratory employees and representatives of Third Party Providers, to meet with employees or representatives of AbbVie (or its Affiliate or designated Third Party Provider, as applicable) at the applicable manufacturing facility and make available all necessary equipment, at mutually convenient times, to support and execute the provision of all applicable analytical methods and the validation thereof (including all applicable Know-How, Information and Materials Controlled by Caribou, and sufficient supplies of all primary and other reference standards); (d) Caribou shall, and shall cause its Affiliates to, take such steps, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers take such steps, as are necessary or reasonably useful to assist AbbVie (or its Affiliate or designated Third Party Provider, as applicable) in obtaining any necessary licenses, permits or approvals from Regulatory Authorities with respect to the Manufacture of the applicable Collaboration CAR-T Products and corresponding Licensed Products at the applicable facilities; and (e) Caribou shall, and shall cause its Affiliates to, provide, and shall use Commercially Reasonable Efforts to assist AbbVie in causing Third Party Providers to provide, such other assistance as AbbVie (or its Affiliate or designated Third Party Provider, as applicable) may reasonably request to enable AbbVie (or its Affiliate or designated Third Party Provider, as applicable) to use and practice each Manufacturing Process and otherwise to Manufacture the applicable Collaboration CAR-T Products and corresponding Licensed Products.

  • API If the Software offers integration capabilities via an API, your use of the API may be subject to additional costs or Sage specific policies and terms and conditions (which shall prevail in relation to your use of the API). You may not access or use the API in any way that could cause damage to us or the Software, or in contravention of any applicable laws. We reserve the right in our sole discretion, to: (i) update any API from time to time; (ii) place limitations around your use of any API; and (iii) deny you access to any API in the event of misuse by you or to otherwise protect our legitimate interests.

  • Packaging Tangible product shall be securely and properly packed for shipment, storage, and stocking in appropriate, clearly labeled, shipping containers and according to accepted commercial practice, without extra charge for packing materials, cases, or other types of containers. All containers and packaging shall become and remain Customer’s property.

  • Packaging and Shipping All shipping containers shall be packed and packaged to: (i) ensure safe arrival to final destination; (ii) secure the lowest transportation costs;(iii) comply with requirements of common carriers; (iv) meet Buyer's written instructions; and (v) meet the requirements of all applicable laws, ordinances, rules and regulations.

  • Manufacturing Rights (a) If QED fails to supply Product ordered by ViewRay in accordance with the terms of this Agreement regarding the quantity or quality of Products supplied to ViewRay, then QED shall within fifteen (15) Business Days of said failure present ViewRay with a plan to remedy the problem and shall use Commercially Reasonable Efforts to execute such plan and remedy the problem or QED shall secure an alternative source of supply within a reasonable time at no additional cost to ViewRay. Any such alternative source of supply shall be on terms substantially identical with the terms of this Agreement. If QED is unable to provide a plan to remedy the problem or secure an alternative source of supply within [***] after its initial failure to supply, then QED shall consult with ViewRay and the parties shall work together to remedy the problem. If QED is unable to remedy the supply problem after [***] (or longer as agreed in writing by the parties), commencing with the date upon which such failure to supply began, then ViewRay may at its option, and upon notice to QED, manufacture the Products itself or through a third party in accordance with the provisions of Section 3.10(b). [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (b) If ViewRay notifies QED pursuant to Section 3.10(a), above, that ViewRay will manufacture the Products itself or through a third party, QED shall (i) deliver to ViewRay within thirty (30) days media embodying or disclosing all Program technology and Program proprietary or intellectual property rights necessary to enable ViewRay or its designee to manufacture Products conforming with the Specifications; and (ii) provide ViewRay or its designee, upon request, with reasonable assistance in establishing a back-up manufacturing line. ViewRay shall require any third party ViewRay designates to manufacture Products pursuant to this Section 3.10, to agree in writing to observe the terms of this Agreement relating to confidentiality and the manufacture of Products. Notwithstanding any provision of this Section 3.10 to the contrary, in no case shall QED be required to pay ViewRay in respect of any Products purchased by ViewRay from a third party operating a back-up manufacturing line established pursuant to this Section 3.10 or manufactured by ViewRay or its Affiliates pursuant to this Section 3.10.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

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