Packaging, Labeling and Storage Sample Clauses

Packaging, Labeling and Storage. Centrally supplied alendronate will not be repackaged for the study, but will be over-labeled according to local regulatory requirements as necessary. Calcium and vitamin D supplements will not be relabeled for the study.
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Packaging, Labeling and Storage. All Product manufactured by APC shall be suitably stored, packaged and labeled in accordance with all Regulatory Standards, the Specifications and Revance’s written instructions, to protect it from degradation and minimize loss. Subject to the above, Product shall be minimally labeled: “Caution: New Investigational Material, for manufacturing, processing, or repackaging in the preparation of a new drug limited by Federal (or United States) Law to investigational use only.”.
Sample 1
Packaging, Labeling and Storage. Dynal shall be responsible for packaging and labeling the Products in accordance with cGMP and the Specifications. Xcyte shall provide Dynal with all the information to be included on the labels of the Products except the batch specific data, and Dynal shall order such labels based upon information provided to Dynal by Xcyte. Upon receipt of the blue print labels, Dynal shall send a sample of each to Xcyte for review and final approval. If Xcyte has any revisions to such samples, Xcyte shall notify Dynal promptly of such revisions, but in no event later than twenty-one (21) days after Xcyte’s receipt of each such sample from Dynal. If Xcyte does not provide Dynal with comments within such 21-day period, Dynal shall label the Products using the form of such labels as in the sample provided to Xcyte. Xcyte shall be solely responsible for ensuring that all labels for the Products are in compliance with applicable laws and regulations. Dynal shall store the Products in accordance with cGMP and the Specifications. All shipment of the Products will follow the cGMP requirements regarding the (i) packaging (ii) monitoring of the shipment in terms of temperature and time (iii) documentation. Xcyte is responsible for shipment validation.
Sample 1
Packaging, Labeling and Storage. The Antibodies will be filled aseptically in sterile containers by the Antibody Manufacturer and labeled with the description of the Antibody, including the lot number from the Antibody Manufacturer, volume and expiry date. Antibodies will be at all times stored under controlled, validated conditions according to the Specifications, and following the cGMP requirements. All shipment of Antibodies (from the Manufacturer to Xcyte and from Xcyte to Dynal) will follow the cGMP requirements regarding the (i) packaging (ii) monitoring of the shipment in terms of temperature and time (iii) documentation. Xcyte is responsible for shipment validation. The Antibodies will be shipped to Dynal CIP Oslo, Norway (Incoterms 1990).
Sample 1
Packaging, Labeling and Storage. Beovu 120mg/mL solution for injection in pre-filled syringe. Each pre-filled syringe contains 19.8mg of brolucizumab in 0.165mL solution. This provides a usable amount to deliver a single dose of 0.05mL containing 6mg of brolucizmab. For study drug in vials, the study drug will be withdrawn using aseptic technique. Study drug will be shipped to the site via overnight shipping using cold packs to maintain a temperature of 2° to 8° C. The Investigator, or an approved representative (e.g. study coordinator), will ensure that all study drugs are stored in a secured area, under recommended storage conditions and in accordance with applicable regulatory requirements. The shipping box is to be opened and stored immediately at the site in a refrigerator intended for investigational products at a temperature of 2° to 8°C. When vials are removed from the refrigerator, the solution should be visually inspected and it should have no evidence of turbidity. If particulates, cloudiness, or discoloration are visible, the vial must not be used. Exposure of the material to temperatures outside these limits, except for warming prior to administration, is not recommended and may result in loss of activity. Records of actual storage conditions (i.e. temperature log) at the study site must be maintained; and must include a record of the dates, when the refrigerator was checked, the initials of person checking, and the temperature.
Sample 1

Related to Packaging, Labeling and Storage

  • 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.

  • 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.

  • 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.

  • Product Labeling The labeling of all Licensed Products sold or offered for sale under this Agreement shall expressly state that the Licensed Product is manufactured under a license from the Medicines Patent Pool.

  • Labeling Upon request, Lessee will xxxx the Equipment indicating Lessor's interest with labels provided by Lessor. Lessee will keep all Equipment free from any other marking or labeling which might be interpreted as a claim of ownership.

  • Labelling The distributor, on behalf of the selected vendor agrees that all supplies of articles should invariably contain the following information on its label and the carton. One information should not be overlapped by any other information needed to be furnished. The label should contain : a. Name of the item as approved b. CMS Cat. No. c. Manufacturing date/Import date for the imported items. d. Expiry Date. (where applicable) e. Name & address of Registered Office of Manufacturers and place of manufacture. f. Manufacturing License Number. (where applicable for Manufactures) g. Batch Number (where applicable) h. Month and Year of supply. i. The label & Carton must invariably marked “W B. GOVT SUPPLY : NOT FOR SALE”. j. All Surgical items quoted/supplied by the tenderer must conform to IS /BIS /CE/USFDA. Pacemker must conform to CE & US FDA norms. In case of Drugs items quoted /supplied by tenderer MUST CONFORM TO IP, BP, or USP norms and N.F.I. –III specification as noted against the item(s) in catalogue as applicable. k. The MRP and Trade Name will not be allowed to be printed in any pack. This will lead to cancellation of candidature straightaway. However, for excisable products, insertion of writing of Govt MRP is allowed as per provision laid down in the order of the Central Excise dept. However, for imported item(s), MRP and Trade name may be allowed in addition to Generic name.

  • 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.

  • 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);

  • PACKING AND SHIPMENT (a) Unless otherwise specified, all Work is to be packed in accordance with good commercial practice. (b) A complete packing list shall be enclosed with all shipments. SELLER shall mark containers or packages with necessary lifting, loading, and shipping information, including the LOCKHEED XXXXXX Contract number, item number, dates of shipment, and the names and addresses of consignor and consignee. Bills of lading shall include this Contract number. (c) Unless otherwise specified, delivery shall be FOB Place of Shipment.

  • Packaging Materials and Containers for Retail Sale 1. When packaging materials and containers in which a good is packaged for retail sales are classified in the Harmonized System with the good, they shall not be taken into account in determining whether all non-originating materials used in the production of the good undergo the applicable change in tariff classification set out in Annex 4.03. 2. When the good is subject to a requirement of regional value content, the value of these packaging materials and containers shall be taken into account as originating or non-originating materials, as the case may be, in calculating the regional value content of the good.

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