Master Cell Bank Sample Clauses
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Master Cell Bank. During the Term, Protalix shall, as the supplier of Drug Substance, maintain half of the master cell bank relating to the Drug Substance in a location selected by Protalix and the other half of the master cell bank relating to the Drug Substance at a different location selected by Protalix and approved by Pfizer (such approval not to be unreasonably withheld or delayed), which may include the Facility where Pfizer performs Fill/Finish activities (provided that Pfizer obtains all required approvals from the applicable Regulatory Authority necessary to store the master cell bank in such Facility).
Master Cell Bank. It is understood that as of the Effective Date, Biogen Idec has in inventory the cell line [***] (the “Master Cell Bank”) used to manufacture the Existing Inventory and engineered using certain technology of Biogen Idec and certain other technology [***] as further described in the License Agreement.
2.5.1 [***]
Master Cell Bank. BLSI hereby acknowledges the proprietary and highly confidential nature of the Master Cell Bank. At all times during the term of this Agreement BLSI shall ensure that the Master Cell Bank (i) is maintained in accordance with applicable laws and generally prevailing industry standards and (ii) is not transferred or provided to any Third Party, provided that BLSI may (x) transfer the Master Cell Bank to a Third Party to store and maintain the Master Cell Bank on BLSI's behalf in accordance with this Section 3.8 and (y) provide access to the Master Cell Bank to a Third Party manufacturer solely for the purpose of manufacturing the Licensed Product, and provided further that each such Third Party be under strict confidentiality obligations.
Master Cell Bank. As promptly as practicable after the Effective Date, Immunomedics shall transfer, or cause to be transferred, *** of the Master Cell Bank to Licensee (or at the direction of Licensee, to the Third Party manufacturer contemplated by this ARTICLE 8), for the purpose of Licensee (or the Third Party Manufacturer) creating, or having created, a working cell bank for production of the Product in the Field.
Master Cell Bank. A culture of (fully characterized) cells distributed into containers in a single operation, processed together in such a manner as to ensure uniformity and stored in such a manner as to ensure stability. A master cell bank is usually stored at -70°C or lower.
Master Cell Bank. 3.1 Within [***] days after the Effective Date, Candel shall deliver the following:
3.1.1 [***] vials from the Candel 5B4 Master Cell Bank (collectively, the “Master Cell Bank”) to PeriphaGen or to a Third Party (which Third Party will be approved by Candel in writing in advance) storage facility identified by PeriphaGen, such delivery to be at PeriphaGen’s sole cost and expense for freight and insurance; and
3.1.2 True, correct and complete copies of the following documents relating to the Master Cell Bank: completed batch records; information sufficient to describe the manufacture of the Master Cell Bank; passage number for each vial of the Master Cell Bank; Certificates of Analysis, Conformance, Deviation and/or Investigation for the Master Cell Bank; any Quality Assurance statements, GMP statements, or BSE/TSE statements for the Master Cell Bank; Certificates of Analysis of raw materials used in manufacturing the Master Cell Bank; and reports of all testing carried out on the Master Cell Bank (sterility, adventitious agents, identity, mycoplasma, viability, recovery, etc.) (collectively, the “Records”), all of the foregoing to be delivered to PeriphaGen. The Parties shall cooperate in good faith with respect to delivery of the Records and such other information relating to the Master Cell Bank that PeriphaGen may reasonably request.
3.2 Within [***] days after the Effective Date, Candel shall take all steps, and pay all expenses, necessary to ensure that when the Master Cell Bank and associated documentation are delivered pursuant to Section 3.1 above, they will be fully compliant with the Good Manufacturing Practice regulations promulgated by the United States Food and Drug Administration. Within [***] days after the Effective Date, Candel shall provide written confirmation to PeriphaGen that it has taken all such steps and paid all such expenses. In the event that any vial of the Master Cell Bank as delivered to PeriphaGen is not sterile, viable, free of adventitious agents, and recoverable, PeriphaGen shall provide any applicable tests to Candel demonstrating the same and Candel shall replace such vial with a new vial of the Master Cell Bank within [***] days.
3.3 Candel hereby grants to PeriphaGen a non-exclusive, fully paid-up, royalty free, license, with the right to grant sublicenses subject to Section 3.3.3 below, to use the Master Cell Bank and the Records to conduct research and to develop, make, have made, use, have used, offer for sale, sel...