Cell Banks. Within forty-five (45) days of receipt of an invoice from Diaclone with respect thereto, Xcyte [*] The parties acknowledge and agree that Xcyte [*] the parties anticipate that the remainder of such costs will be an additional amount of approximately [*]
Cell Banks. 13 5.16 Disclaimer.................................................... 13
Cell Banks. The Working Cell Banks are in viable condition as of the Closing. The Master Cell Banks have been stored following quality procedures in accordance with current good manufacturing practice (cGMP).
Cell Banks. All right, title and interest in and to any Unigene Cell Bank set forth on Appendix E (including without limitation the underlying cell line) belong to Unigene, and are included in the Unigene Know-How and/or, to the extent included therein, Unigene Patent Rights, and are therefore included within the license grant in Section 2.1.
1. Appendix E shall be amended promptly in writing by the Parties from time to time, as additional Unigene Cell Banks may be provided or created in accordance with the Agreement. In furtherance of the foregoing, the Parties agree and acknowledge that: (a) in the event that (i) Unigene provides a Unigene Cell Bank to GSK, and (ii) GSK does no more to the Unigene Cell Bank than create a new master or working cell bank from that cell bank or change the media and/or the host cell, wherein if the host cell is changed and the new host cell is known in the public domain, then Unigene shall continue to own such Unigene Cell Bank in both its original and newly created forms, and the newly created form shall be added to Appendix E; and (b) in the event GSK solely creates a Cell Bank that utilizes Unigene Patent Rights and/or Unigene Know-How and which newly created Cell Bank incorporates GSK intellectual property in its plasmid vector or the host cell such that a new host cell that contains GSK Know-How or GSK intellectual property is created, such newly created Cell Bank (and any cell line based on such Cell Bank) shall be owned solely by GSK, shall not be set forth on Appendix E and shall be deemed a Dependent GSK Improvement. For clarity, nothing in this Agreement grants to Unigene rights to such incorporated GSK intellectual property independent of GSK Dependent Improvements. To facilitate amendment of Appendix E, GSK shall use Commercially Reasonable Efforts to provide prompt written notice to Unigene of the creation of any additional Cell Bank using any Unigene Cell Bank, Unigene Patent Rights and/or Unigene Know-How. Any information shared with Unigene in this regard shall be deemed Confidential Information under this Agreement.
Cell Banks. To the extent the following relate to the Product or the Process in the Exclusive Fields: [***] [***] Indicates portions of this exhibit that have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment. Exhibit A has been intentionally omitted as the Supply Agreement has been previously filed with the SEC as follows:
Cell Banks. The parties acknowledge that the good faith cost estimates set out in Schedule 2.4(b) attached hereto for the generation of cell banks in the Alliance Workplan are not covered by the funding specified in Section 2.4(i) and (ii) and are separate costs to be paid by GEHC to Geron, subject to GEHC’s prior written approval, if GEHC requests the generation of such cell banks.
Cell Banks. 9.6.1 Fate shall be responsible for generating the Master iPSC Bank for each Licensed Product. The JMC shall oversee the progress of the generation of the Master iPSC Bank and determine whether to generate working cell banks.
9.6.2 Upon Xxxxxxx’x exercise of the Commercial Option for a Pre-IND Collaboration Candidate, [***]. Unless the JMC determines otherwise, during the Term, the Master iPSC Bank shall be stored in at least two locations selected by the JMC, one of which will be a Fate manufacturing facility and one of which will be a location controlled by Xxxxxxx.
9.6.3 Each Party shall hold the Master iPSC Bank at a facility approved by the JMC. Fate shall use the Master iPSC Bank, and the Parties shall use CD34 Compositions, only to Manufacture Licensed Products as permitted under this Agreement. Neither Party shall permit any Third Party to access such Master iPSC Bank, except a Third Party manufacturer is permitted to receive vials from such Master iPSC Bank solely for the Manufacture of Licensed Products. With respect to any portion of the Master iPSC Bank stored by a Party, each Party acknowledges and agrees that:
(a) the Master iPSC Bank shall be, and shall at all times during the Term remain, subject to Xxxxxxx’x exclusive rights under Section 9.6.2;
(b) each Party will use a control system to ensure the Master iPSC Bank is properly secured and has limited authorized access;
(c) each Party will maintain the Master iPSC Bank under validated storage conditions designed to maintain viability, prevent contamination and otherwise maintain GMP compliance, and such storage conditions will be actively monitored and documented;
(d) each Party will provide documentation upon request regarding the use of the vials from the Master iPSC Bank and monitored storage conditions, the foregoing shall not be construed to expand a Party’s right to access or use of such Master iPSC Bank; and
(e) each Party shall conspicuously xxxx the Master iPSC Bank as subject to the terms of this Section 9.6.3.
9.6.4 [***]; provided, however, that the Parties agree that Fate shall be the Party responsible for the re-generation of the Master iPSC Bank unless Fate is unable to carry out such responsibility. Except as set forth above, Fate shall have the exclusive right to conduct the Cell Bank Process and Cell Bank Process Development under this Agreement.
Cell Banks. The Parties acknowledge that the transfer of any vials of Praluent Master Cell Bank or Praluent Working Cell Bank from Regeneron to Sanofi will be carried out as and to the extent set forth in the Drug Substance Tech Transfer Plan and, notwithstanding anything herein to the contrary, at [* * *].
Cell Banks. Manufacturer shall be responsible for the biological purity and maintenance of the master cell bank and any working cell banks maintained by Manufacturer, it being understood that no working cell bank is maintained as of the Effective Date for the Product. This includes monitoring for viability by the procedures set forth in the Quality Agreement. Upon Buyer’s request, Manufacturer shall provide Buyer with any requested number of vials of viable cells from the master cell bank, together with the thawing and storage protocols, within ninety (90) days of such request, but limited to an aggregate (combining all such requests) of twenty (20) vials (including any vials provided as part of a manufacturing transfer). From time to time thereafter (i.e., after twenty (20) such vials have been provided in the aggregate), Manufacturer shall deliver to Buyer such additional vials of viable frozen cells from the master and any working cell banks as may be reasonably requested within twenty-four (24) months of any such request.
Cell Banks. The Cell Banks are in viable condition as of the Closing and have been stored in accordance with any and all applicable laws, rules, regulations, Governmental Authorizations and the quality procedures in accordance with cGMP.
