Limited Use Label License for Engineered Cell Lines

BEFORE USING THIS PRODUCT, PLEASE READ THE TERMS AND CONDITIONS SET FORTH IN THIS LULL. YOUR USE OF THIS PRODUCT SHALL CONSTITUTE ACKNOWLEDGMENT AND ACCEPTANCE OF THESE TERMS AND CONDITIONS.

In this LULL the following shall mean:

"Commercial Use" any and all uses of the Licensed Materials, by the Licensee for monetary or other consideration, including but not limited to (i) Manufacturing of a product for sale, and (ii) Sale of the Licensed Materials, whether or not such sale is limited for use in research, and (iii) Provision of a service to a third party involving Licensed Materials that generates any information or data;

"Derivatives" any substances which constitute a sub-unit or product expressed by the Licensed Materials including but not limited to proteins or nucleic acids;

"Diagnostic Use" any and all uses of the Licensed Materials, by the Licensee for the development or implementation of assays intended for diagnostics use, including but not limited to: (i) Development of platforms or assays intended for diagnostic use; and (ii) Validation or verification of platforms or assays intended for diagnostic use; and (iii) Development of reagents intended for diagnostic use;

"Licensed Materials" are the Product, Progeny, Modifications or Derivatives of the Product;

"Licensee" the individual or legal entity purchasing the Product;

"Modifications" any modifications of the Product;

"Product" the cell line(s) purchased by Licensee from Horizon or its distributors under the terms of this LULL; OR cells modified by Horizon using CRISPR technology and provided to the Licensee under the terms of the Agreement (including this LULL).

"Progeny" any unmodified descendant form of the Product;

"Third-Party Contractors" a contractor engaged by Licensee conducting services solely for Licensee's benefit and which is bound with Licensee by a contractual relationship whose terms are consistent with and as stringent as the terms of this LULL.

1. The purchase of the Product grants the Licensee the non-exclusive, non-transferable, non-sublicensable license to use the purchased Product for Licensed Research only (see definition below) subject to the conditions set out in this LULL. Licensee’s right to use this Product is subject to the following conditions and restrictions:

"Licensed Research Use" means any USE FOR RESEARCH PURPOSES ONLY, other than:

a) Licensing, selling, distributing, or otherwise providing or transferring the Product or Modifications to any third party, whether or not such transfer is limited for use in research; or
b) Manufacture of a commercial product including derivatives produced using the Product; or
c) Provision of commercial services to a third party for monetary gain, including but not limited to delivery of research results from use of the Product; or
d) Use as treatment, diagnostic, or prophylactic of a human or animal.

2. Licensee will use the Product in compliance with all applicable laws and regulations, including applicable human health and animal welfare laws and regulations.

3. Licensee shall be permitted to provide the Product to a Third Party Contractor who utilizes the Product for the sole benefit of the Licensee, provided however that a legal agreement is in place and in force between Licensee and the Third-Party Contractor, whose terms will provide that the ownership of the Product is not transferred to the Third-Party Contractor and Licensee can require the return of the Product at any time.

4. Licensee will indemnify, defend and hold harmless Horizon and its licensors against any liability, damage, loss or expense (including reasonable attorneys’ fees and expenses) incurred by or imposed upon them by your use of the Product.

5. The terms of this LULL shall commence on the day the Product is received and continue in perpetuity. Horizon may terminate this LULL with immediate effect by providing notice to Licensee at any time, should Licensee breach any provisions of this LULL.

6. Except for the rights granted under this LULL, no other rights are transferred to Licensee in relation to the Licensed Materials. Any data generated by the Licensee using the Licensed Materials, are owned by the Licensee, subject to the use restrictions set forth herein.

7. FOR HAPLOID CELL LINES (including the KBM7, HAP1 and eHAP cell lines) ONLY: In addition to the above, the below shall also apply:

7.1. This Product is for research use only, and it may not be used for the following "Restricted Activities": (i) any therapeutic or prophylactic, human or veterinary use; and (ii) conducting services.

7.2. This Product may not be resold, redistributed, or transferred, except that it may be transferred, by the purchaser or by Horizon on behalf of the purchaser, to a third-party contract service provider solely to conduct studies on purchaser’s behalf.

7.3. Any use of this product for performing Restricted Activities requires a separate license from the Whitehead Institute for Biomedical Research. The foregoing restrictions amount to a restricted license under applicable patent and other intellectual property rights.

8. Certain drug screening, target validation and toxicity testing methods that utilize in-vitro differentiated disease models may be covered by one or more patents controlled by Evotec International GmbH. Those patents include EP2270196B1, EP1745144B1 and EP3070174B1 and corresponding foreign patents and pending applications. The purchase or transfer of this product is not intended, either expressly or by implication, to grant any right or license to practice under the foregoing patents. Purchasers are advised to contact Evotec International GmbH at info@evotec.com for information regarding a license to practice under such patents.

9. THE PRODUCT IS SUPPLIED "AS IS" WITH NO WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, TITLE, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE OR THAT THE PRODUCT IS FREE FROM ANY THIRD-PARTY CLAIMS.

10. In no event shall Horizon or its affiliates, directors, officers or employees or their respective representatives be liable to Licensee or its affiliates, whether based in contract, tort, warranty or any other legal or equitable grounds, for any loss of income, profit or savings or cost of capital of Licensee or its affiliates, for any direct, indirect, incidental or consequential damages resulting from or relating to the Product or Licensee’s use thereof.

11. Upon termination of the LULL, for any reason, the Licensed Materials must be destroyed and notification of such destruction provided to Horizon.

12. The terms of this license incorporate and are subject to Horizon’s terms and conditions which can be accessed at https://horizondiscovery.com/-/media/Files/Horizon/legal/horizon-discovery-product-terms-conditions.pdf. The terms of this license shall be governed in accordance with English Law and the English court shall have exclusive jurisdiction on any disputes arising out of or in connection with this LULL.

13. FOR CRISPR Cas9 KNOCK-IN PRODUCTS AND SERVICES ONLY, in addition to the above, the below Sigma-Aldrich CRISPR Use License Agreement provisions shall apply ("Sigma LULL"). In case of conflict between the LULL and the Sigma LULL, the Sigma LULL shall prevail:

Sigma-Aldrich CRISPR Use License Agreement

This Product and its use are the subject of one or more of the following patents and applications controlled by Sigma-Aldrich Co. LLC ("SIGMA"): Patent applications and issued patents that entered their respective National Stage from PCT International Pub. No. WO 2014/089290, including, but not limited to, the following, and substitutions, divisions, continuations, continuations-in-part, reissues, re- examinations, and extensions thereof: Australia Patent Nos. 2013355214; 2017204031; and 2018229489; Canada Patent Nos. 2,891,347 and 2,977,152; China Patent No. CN105142669; European Patent Nos. EP 2 928 496 B1; EP 3 138 910 B1, 3 138 911 B1, EP 3 138 912 B1, EP 3 360 964 B1, EP 3 363 902 B1; Israel Patent No. IL238856; Singapore Patent No. 11201503824S; South Korea Patent Nos. 10-1844123 and 10-2006880; and U.S. Patent Nos. 10,731,181 and 10,745,716; and U.S. Application Serial Nos. 15/188,927; 15/188,931; and 15/456,204 (the "Patent Rights").

BEFORE OPENING OR USING THIS PRODUCT, PLEASE READ THE TERMS AND CONDITIONS SET FORTH IN THIS LICENSE AGREEMENT. YOUR USE OF THIS PRODUCT SHALL CONSTITUTE ACKNOWLEDGMENT AND ACCEPTANCE OF THESE TERMS AND CONDITIONS.

If you do not agree to use this Product pursuant to the terms and conditions set out in this License Agreement, please contact Horizon Discovery within ten (10) days of receipt to return the unused and unopened Product for a full refund; provided, however, that custom-made Products may not be returned for a refund.

The purchase of this Product conveys to you (the "Buyer") the NON-TRANSFERABLE right to use the purchased Product for Licensed Research Use (see definition below) subject to the conditions set out in this License Agreement. If you wish to use this Product for any purpose other than Licensed Research Use, you must first obtain an appropriate license (see information set out below).

This Product may not be used for any purpose other than Licensed Research Use. Your right to use this Product for Licensed Research Use is subject to the following conditions and restrictions:

1. "Licensed Research Use" means any use for research purposes, with the following exceptions:
(i) Buyer may not sell or otherwise transfer the Product (including without limitation any material that contains the Product in whole or part) or any Related Material to any other Third Party (except that you may transfer the Product, including without limitation any material that contains the Product in whole or in part, or any Related Material to a bona fide collaborator or contract research person or entity), or use the Products or any Related Material to perform services for the benefit of any other person or entity; (ii) Buyer may use only the purchased amount of the Product (and any genotypically and phenotypically identical progeny therefrom if Product is a cell line) and components of the Product, and shall use any Related Material, only for your internal research within the Field, and not for any Commercial Purposes; (iii) Buyer shall use the Product and any Related Material in compliance with all applicable laws and regulations, including without limitation applicable human health and animal welfare laws and regulations; (iv) SIGMA shall provide no warranties of any kind to the Buyer (statutory or implied) concerning the Patent Rights, the Product or any Related Materials, including without limitation, as to product quality, condition, description, merchantability, fitness for a particular purpose, noninfringement of intellectual property rights or the absence of latent or other defects, and all such warranties are hereby expressly disclaimed; (v) SIGMA shall expressly disclaim any warranty regarding results obtained through the use of the Product or Related Materials, including without limitation any claim of inaccurate, invalid or incomplete results; (vi) SIGMA, and their directors, officers, employees and agents, shall have no liability to the Buyer, including, without limitation, for any loss of use or profits, business interruption or any consequential, incidental, special or other indirect damages of any kind, regardless of how caused and regardless of whether an action in contract, tort, strict product liability or otherwise; (vii) the Buyer shall indemnify, defend, and hold harmless SIGMA and their current directors, officers, employees and agents, and their respective successors, heirs and assigns (the "Indemnities") against any 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 exercise of any rights granted to the Buyer hereunder or any breach of this License Agreement by such Buyer; and (viii) the Product and its use may be the subject of one or more issued patents and/or pending patent applications owned by SIGMA and the purchase of the Product does not convey a license under any claims in the foregoing patents or patent applications directed to the Licensed Product or use, production or commercialization thereof.

2. For purposes of Section 1 above, the following definitions shall apply:

"Commercial Purposes" means (a) the practice, performance or provision of any method, process or service, or (b) the manufacture, sale, use, distribution, disposition or importing of any product, in each case (a) or (b) for consideration, e.g., a fee, or on any other commercial basis.

"Field" means Use of the Patent Rights to develop, create, offer for Sale and Sell Licensed Products and Licensed Services for research purposes only. The Field shall expressly exclude
(a) the use of cell-based potency, safety, or efficacy assays in any manufacturing activity to evaluate potential cell therapy, gene therapy, immunotherapy, or immuno-oncology therapeutics, (b) any bioproduction involving any form of clinical trials or production of biologics-based therapeutic drugs including protein-based therapeutics, (c) any in vivo and ex vivo human or clinical use, including without limitation, any administration into humans or any diagnostic or prognostic use, (d) any in vivo veterinary or livestock use, or agricultural use, (e) the creation of transgenic rodent models and/or derivatives thereof (including, but not limited to, rodents’ cells and rodents’ organs) by for-profit entities, (f) the manufacture, distribution, importation, exportation, transportation, sale, offer for sale, marketing, promotion or other exploitation or use of, or as, a testing service, batch/lot/product release assays for manufacturing therapeutics or therapeutic
candidates, or therapeutic or diagnostic for humans or animals, (g) use of the Patent Rights for the creation of any genetically modified animals, (h) creation or derivation of cell lines from any transgenic rodent animal that was itself created or genetically modified using the Patent Rights, (i) use in human germ line editing, (j) use in gene drive applications, (k) use in production of illicit drugs, or (l) use in tobacco. "Related Materials" means any progeny, modification or derivative of a Product.

3. Your right to use the Product will terminate immediately if you fail to comply with these terms and conditions. You shall, upon such termination of your rights, destroy all Product, Related Materials, and components thereof in your control, and notify SIGMA of such in writing.

For information on purchasing a license to this Product for purposes other than Licensed Research Use, contact the Sigma Business Development team at geneeditingip@milliporesigma.com

For any use of the Product outside the terms of this LULL, including any commercial, diagnostic, therapeutic or prophylactic uses, please contact: Horizon Discovery Ltd., 8100 Cambridge Research Park, Waterbeach, Cambridge, CB25 9TL, United Kingdom.

Updated date: 9 April 2024