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 & ▇▇▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇, 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 ▇▇▇▇ containing cartons shall be of at least 5 ply with bursting strength not less than 9 kg/sqcmGlass ▇▇▇▇ containing cartons shall be of at least 7 ply with bursting strength not less than 12 kg/▇▇▇▇.▇▇ 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.
MANUFACTURING AND PACKAGING. 3.1 VGN will be responsible for the manufacture, packaging and release for sale of the Product in accordance with the approved license application and its prevailing Standard Operating Procedures (SOPs).
3.2 VGN will supply to OA Product meeting the Australian approved specifications.
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 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.
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. 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. 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, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇. ▇▇▇ ▇▇▇▇▇▇r ▇▇▇▇▇▇ that, ▇▇▇withstanding 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 th▇ ▇▇▇mulation 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