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Gene Therapy Licence

V. 29/10/2020 © OXGENE. All rights reserved

TESSA Limited Use Label Licence

IMPORTANT INSTRUCTIONS – READ CAREFULLY:

Oxford Genetics Ltd (“OXGENE”) has developed a proprietary Tet Enabled Self Silencing Adenoviral (TESSA) technology, protected by the Patent Rights, that includes, without limitation, adenoviral vectors that embody the TESSA technology (“TESSA Products”).

This Limited Use Label License Agreement (“LULL”) is the legal agreement between you (“Licensee”) and OXGENE regulating the use of TESSA Product(s) purchased from OXGENE. By using the TESSA Products, Licensee agrees to be bound by the terms of this LULL, which apply to the TESSA Products and to any progeny, derivatives or components of TESSA Products (“Progeny”). A reference to TESSA Products in this LULL shall be understood to include Progeny, whether or not this is expressly stated.

OXGENE hereby grants to Licensee the non-transferable, non-exclusive, limited right, without the right to grant sublicences, to use TESSA Product(s) purchased from OXGENE to produce, manufacture and titrate adeno-associated viral (AAV) vectors for Research Purposes, Commercial Purposes, or GMP Manufacturing Purposes, subject to Licensee’s (a) purchase of the appropriate quality grade of TESSA Products from OXGENE for such purposes, and (b) compliance with all of the following requirements.

The purchase of TESSA Products does not confer any right, whether expressly, by implication, or otherwise, to resell, transfer or propagate TESSA Products.

THE USE OF TESSA PRODUCTS IS EXPRESSLY PROHIBITED IN: (A) ANY CLINICAL HUMAN APPLICATION OR USE, INCLUDING, WITHOUT LIMITATION, THERAPEUTIC, DIAGNOSTIC AND PROGNOSTIC USE; (B) ANY HUMAN GERMLINE MODIFICATION, INCLUDING MODIFYING THE DNA OF HUMAN EMBRYOS OR HUMAN REPRODUCTIVE CELLS; (C) ANY IN VIVO VETERINARY OR LIVESTOCK USE; OR, (D) THE MANUFACTURE, DISTRIBUTION, IMPORTATION, EXPORTATION, TRANSPORTATION, SALE, OFFER FOR SALE, MARKETING, PROMOTION OR OTHER EXPLOITATION OR USE OF TESSA PRODUCTS, OR AS, A TESTING SERVICE, THERAPEUTIC OR DIAGNOSTIC FOR HUMANS OR ANIMALS.

Licensee:

  1. shall not sell, transfer or otherwise dispose of TESSA Products to any other person or entity, except for a transfer to a contract manufacturing organisation (“CMO”) for the sole purpose of AAV vector manufacture on Licensee’s behalf for the benefit of Licensee PROVIDED ALWAYS (a) Licensee procures that CMO complies with Licensee’s obligations under this LULL and (b) at the end of the CMO contract all TESSA Products are returned by CMO to Licensee or the CMO certifies in writing to Licensee that they have been destroyed;
  2. is solely responsibility for: (a using TESSA Products in compliance with all applicable laws and regulations, including without limitation applicable human health and animal welfare laws and regulations; and (b) obtaining all permits, licenses or other approvals required by any governmental authority in connection with Licensee’s receipt, handling, storage, disposal, transfer, and use of the TESSA Products;
  3. shall not propagate TESSA Products or expose TESSA Products to: (a) Doxycycline or Tetracycline; or (b) any analogue or chemical derivative of Tetracycline or Doxycycline; or (c) shRNA or siRNAs recognising the TetR coding sequence;
  4. may (notwithstanding (2) above) expose AAV preparations manufactured using TESSA Products to Doxycycline for the sole and limited purpose of assessing potential Progeny of a TESSA Product within an AAV preparation. TESSA Products must not be exposed to Doxycycline for any other purpose, including for the purpose of AAV manufacture;
  5. shall not purify or ligate TESSA Product DNA, sequence, or attempt to reverse engineer TESSA Products;
  6. shall indemnify, defend and hold harmless OXGENE and its current and former directors, officers, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any and all liability, damage, loss, or expense (including without limitation reasonable attorneys’ fees and expenses) incurred by or imposed upon any of the Indemnitees in connection with any claims, suits, investigations, actions, demands or judgments arising out of or related to the use of TESSA Products by the Licensee and the exercise of any rights granted to Licensee under this LULL or any breach of this LULL or any associated agreement between the parties in respect to its subject matter by such Licensee;
  7. acknowledges and agrees that the purchase of TESSA Products does not convey a license under any OXGENE intellectual property rights, directed to the TESSA Product or otherwise, for any purposes or use, production or commercialisation thereof beyond that which is expressly granted under this LULL;
  8. agrees to acknowledge OXGENE as the source of TESSA Products in all research, academic or scholarly publications and in patent applications that reference TESSA Products; and
  9. shall not file any patent application covering any process using the TESSA Products without prior written permission from OXGENE.

Definitions used in this LULL:

“Commercial Purposes” means the practice, performance or provision of any method, process, service, information, or data for financial gain.

GMP Manufacturing Purposes” means use for the manufacture of viral vector for therapeutic, diagnostic, prophylactic or other medicinal products intended for use in humans or non-human animals. If TESSA Product are used in the development of a molecule or any derivative of such molecule that is used in or administered to humans or non-human animals, then the production of such molecule shall be deemed to be GMP Manufacturing.

“Patent Rights” are those rights claimed in one or more pending or issued patents held by OXGENE and any divisional, continuations, continuation-in-part applications, and continued prosecution applications (and their relevant international equivalents) of the patent applications and resulting applications of the same, reissues, re-examinations or extensions worldwide related to use of an: (a) adenoviral vector containing a regulatable major late promoter; (b) an adenoviral vector containing a Rep coding sequence that does contain a promoter upstream; (c) a cell co-infected with an AAV and an adenoviral vector containing either (a) or (b), or both.

Research Purposes” means use for internal research conducted by Licensee or by a contract research organisation on Licensee’s behalf for the sole benefit of Licensee.

V. 29/10/2020
© OXGENE. All rights reserved

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