Secondary packaging Sample Clauses

Secondary packaging. Secondary Packaging shall mean the assembly of the Primary Packaged Product, together with any patient leaflet, into an appropriately labeled box in accordance with this Agreement. The terms "Secondary Packaging" and "Secondary Packaged" in this Agreement shall be construed accordingly.
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Secondary packaging leak proof plastic bag with a minimum thickness of 75 µm. The plastic bag shall be securely closed to prevent the release of any material from the bag if inverted. The closure method must not tear, puncture or otherwise damage the bags.
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Secondary packaging. For pharmaceuticals produced on or before 8 February 2019, it is a requirement that the secondary packaging is marked with either EAN 13- bar code or 2D (GS1 DataMatrix) bar code containing as a minimum an identification key. For pharmaceuticals produced on or after 9 February 2019, it is a requirement that the sec- ondary packaging is marked with 2D (GS1 DataMatrix) bar code containing GTIN, expiry date, batch/lot number and serial number. Primary packaging For all pharmaceuticals for oral use, all pharmaceuticals for external use as well as all phar- maceuticals for injection and for infusion, it is a requirement that the primary packaging is marked with a bar code. However, this requirement shall not apply to tablets or capsules in blister sheets or other similar packaging in which tablets/capsules are single -dosed individu- ally. The bar code must either be an EAN 13 bar code or 2D (GS1 DataMatrix) bar code and must as a minimum contain an identification key. Pharmaceuticals for oral use means: • Tablets or capsules • Oral fluids and drops Pharmaceuticals for external use means: • Ointments, creams or gel • Cutaneous liquids Pharmaceuticals for injection means: • Injection fluid • Concentrate for injection fluid • Powder for injection • Injection fluid in pre-filled syringe Pharmaceuticals for infusion means: • Infusion fluid • Concentrate for infusion fluid • Powder for infusion fluid
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Secondary packaging. CPC shall promptly advise Closure Medical of any FDA inspections and the findings thereof and shall take all reasonable steps necessary to correct deficiencies, if any, found by the FDA relating to packaging of the Device. CPC shall advise Closure Medical of any FDA compliance issues or any quality assurance problems with CPC's packaging facilities used for the packaging of the Device.
Sample 1
Secondary packaging. As soon as practicable after the Effective Date, the Parties will [**] with respect to the Licensed Product for the Territory. During the CMA Transfer Period, Schering has agreed, [**] of the Licensed Product for the Territory. In no event than the later of (a) [**] following the [**], (b)[**] following the [**], GSK will implement the Secondary Packaging function with respect to Licensed Product for those countries in the Territory in which Regulatory Approval is achieved through the approval of the Central Marketing Authorization. GSK will implement the Secondary Packaging function for those countries in the Territory in which [**] receipt of Regulatory Approval in such country. [**] Secondary Packaging [**] as provided in EXHIBIT G hereto. Millennium will use commercially reasonable efforts to facilitate the establishment of GSK as a supplier of Secondary Packaging for the Licensed Product for the Territory. Costs incurred by GSK that are associated with any efforts GSK undertakes or that Millennium must undertake to facilitate the transfer of responsibility to GSK to establish Secondary Packaging will be borne by GSK, [**] in accordance with [**] agreed upon by the Parties.
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Secondary packaging the labels, cartons, shippers, inserts and other Packaging Material commonly recognised as secondary Packaging and approved in writing by IMMUCELL.
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Secondary packaging. Gilead shall provide Xxxxxxx with the core secondary packaging and packaging insert artwork with respect to each Territory Combination Product (“Core Materials”) for use by Xxxxxxx in packaging and labeling such Territory Combination Product. Xxxxxxx shall use the Core Materials to package and label the Territory Combination Product, but shall modify the Core Materials as required by Applicable Law and shall provide any necessary translations. Gilead shall have the right, but not the obligation, to review and approve in advance the Core Materials, as so modified, for any Xxxxxxx Country.
Sample 1
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Secondary packaging. Patheon standard bulk packaging.
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Secondary packaging. Additional packaging components to protect the packaged goods against external physical influences. If the packaging is used in the EPA it must meet the same criteria for ESD as the "Enveloping packaging".
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Related to Secondary packaging

  • 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.

  • 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.

  • 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.

  • Product ACCEPTANCE Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User(s) shall have thirty (30) days from the date of delivery to accept hardware products and sixty (60) days from the date of delivery to accept all other Product. Where the Contractor is responsible for installation, acceptance shall be from completion of installation. Failure to provide notice of acceptance or rejection or a deficiency statement to the Contractor by the end of the period provided for under this clause constitutes acceptance by the Authorized User(s) as of the expiration of that period. The License Term shall be extended by the time periods allowed for trial use, testing and acceptance unless the Commissioner or Authorized User agrees to accept the Product at completion of trial use. Unless otherwise provided by mutual agreement of the Authorized User and the Contractor, Authorized User shall have the option to run testing on the Product prior to acceptance, such tests and data sets to be specified by User. Where using its own data or tests, Authorized User must have the tests or representative set of data available upon delivery. This demonstration will take the form of a documented installation test, capable of observation by the Authorized User, and shall be made part of the Contractor’s standard documentation. The test data shall remain accessible to the Authorized User after completion of the test. In the event that the documented installation test cannot be completed successfully within the specified acceptance period, and the Contractor or Product is responsible for the delay, Authorized User shall have the option to cancel the order in whole or in part, or to extend the testing period for an additional thirty (30) day increment. Authorized User shall notify Contractor of acceptance upon successful completion of the documented installation test. Such cancellation shall not give rise to any cause of action against the Authorized User for damages, loss of profits, expenses, or other remuneration of any kind. If the Authorized User elects to provide a deficiency statement specifying how the Product fails to meet the specifications within the testing period, Contractor shall have thirty (30) days to correct the deficiency, and the Authorized User shall have an additional sixty (60) days to evaluate the Product as provided herein. If the Product does not meet the specifications at the end of the extended testing period, Authorized User, upon prior written notice to Contractor, may then reject the Product and return all defective Product to Contractor, and Contractor shall refund any monies paid by the Authorized User to Contractor therefor. Costs and liabilities associated with a failure of the Product to perform in accordance with the functionality tests or product specifications during the acceptance period shall be borne fully by Contractor to the extent that said costs or liabilities shall not have been caused by negligent or willful acts or omissions of the Authorized User’s agents or employees. Said costs shall be limited to the amounts set forth in the Limitation of Liability Clause for any liability for costs incurred at the direction or recommendation of Contractor.

  • Product Recalls The Company is not aware of any pattern or series of claims against the Company or any of its subsidiaries which reasonably could be expected to result in a generalized product recall relating to products sold by the Company or any of its subsidiaries, regardless of whether such product recall is formal, informal, voluntary or involuntary.

  • Product Supply The Parties shall reasonably cooperate and assist each other in transferring ownership of Product drug product and/or Product drug substance (such material, CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. collectively, the “Product Lots”) set forth in Exhibit A attached hereto as promptly as reasonably practicable following the Effective Date; provided, however, that neither Party shall be required to pay money to any Third Party, commence any litigation with, or offer or grant any accommodation (financial or otherwise) to any Third Party. Such Product Lots shall be delivered EXW (Ex Works) (Incoterms 2010) AMGEN, Thousand Oaks, California. Any expense for shipment shall be borne by AKERO (including any import or export duties or taxes). Subject to the terms of this Section 5.4 and Section 6.2 (Additional AMGEN Warranties), AMGEN transfers the Product Lots to AKERO “as is”, and makes no other representation to AKERO in connection therewith. The Parties have entered into a Quality Agreement substantially in the form attached hereto as Exhibit F, dated as of the date hereof, governing the quality of the Product Lots to be supplied pursuant to this Section 5.4. For the avoidance of doubt, Product Lots consisting of drug product as set forth in Exhibit A supplied pursuant to this Section 5.4 shall be labeled for their intended clinical use as set forth in Exhibit A and the labeling of any Product drug product manufactured after the Effective Date shall be the responsibility of AKERO. Except for the Licensed Materials and such Product Lots to be transferred to AKERO, AKERO shall be responsible for, and shall bear the cost of, obtaining (whether by manufacturing or causing to be manufactured) research, clinical and commercial supplies of the Product. From and after the Effective Date, AKERO shall be responsible for all costs and expenses in connection with the storage of, and any stability studies performed on, the Product Lots.

  • Product Recall (a) If a recall is required by applicable Law, or if Buyer or Supplier reasonably determines that a recall is advisable because the goods may create a potential safety hazard, are not in compliance with any applicable code, standard or legal requirement, or contain a defect or non-conformance with the requirements of this Order occurring or likely to occur in multiple goods, which such defects or non-conformances are substantially similar or have substantially similar causes or effects (collectively a “Serial Defect”), the parties shall promptly communicate such facts to each other. At Buyer’s request, Supplier shall promptly develop a corrective action plan satisfactory to Buyer, which shall include all actions required to recall and/or repair the goods and any actions required by applicable Law (“Corrective Action Plan”) for Buyer’s review and approval. At Buyer’s election, Xxxxx may develop the Corrective Action Plan. In no event shall Buyer and Supplier’s failure to agree on the Corrective Action Plan delay the timely notification of a potential safety hazard, non-compliance or Serial Defect to users of the goods, cause either party to be non-compliant with applicable Law or prevent Buyer from taking reasonable actions to prevent injury or damage to persons, equipment or other property. Supplier and Buyer shall cooperate with and assist each other in any corrective actions and/or filings, if applicable.

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