Episomal iPSC Reprogramming Vectors

Notice to Purchaser: This product is authorized for reprogramming methods that involve or pertain to the preparation of iPS cells and their derivatives thereof, including differentiated cells. The purchase of this product conveys to the purchaser the limited, non-transferable right to use the purchased amount of product to perform internal research, subject to the limitations herein. For purposes of this Limited Use Label License, purchasers are either commercial purchasers or academic purchasers. Academic purchasers are institutions of higher learning that are set up as 501(c)(3) organizations and other non-profit entities that are not set up by, or affiliated with, commercial entities or their foundations. All other purchasers shall be deemed commercial purchasers hereunder.

The following restrictions apply to commercial purchasers:

The iPS cells and their derivatives thereof (which derivatives, include without limitation differentiated cells) made by commercial purchasers from this product are for internal research purposes only and may not be (a) used for any commercial purposes, (b) used in or administered into humans, nor (c) used for any therapeutic purpose or for the development of therapeutic applications. Commercial purposes for commercial purchasers include, without limitation, (i) target discovery, target validation and assay development; (ii) fee-for-service research projects for third parties that may include the transfer of materials, services, information or data (including targets identified) for a fee; (iii) conventional screening or high-throughput screening for hits; (iv) in vitro and in vivo safety testing; (v) hit-to-lead, lead optimization or other later-stage development of therapeutics, diagnostics, prophylactics or manufacturing; or (vi) commercialization of drug candidates.

Commercial purchasers may only transfer the iPS cells and their derivatives thereof to academic entities; provided that, the academic recipient agrees to be bound by the terms and use restrictions of this Limited Use Label License applicable to academic purchasers. No other transfers are permitted under this license without a commercial license from Cellular Dynamics International, Inc. Commercial purchasers who seek to obtain additional use, commercial or therapeutic rights of the product, the iPS cells or their derivatives thereof may contact Cellular Dynamics International, Inc. at support@cellulardynamics.com.

The following restrictions apply to academic purchasers:

The iPS cells and their derivatives thereof (which derivatives, include without limitation differentiated cells) made by academic purchasers from this product are for internal research purposes only and may not be (a) used for any commercial purposes, (b) used in or administered into humans, nor (c) used for any therapeutic purpose or for the development of therapeutic applications. Commercial purposes include items (i) through (vi) described above; except that for academic purchasers only, the following shall not be deemed to be a commercial purpose: (A) target discovery, target validation and assay development; (B) screening (conventional or high-throughput) of candidate compounds for development of therapeutics for internal not-commercially sponsored research or on behalf of a third party that has obtained appropriate commercial rights from Cellular Dynamics International, Inc.; (C) commercially sponsored research that is not the development of equipment or culture media, drug candidate screening or hit-to-lead or lead optimization; or (D) activities described in (A) through (C) conducted by academic core facilities for other academic and non-profit entities. However academic purchasers in connection with items (A) through (D) above may not propagate more than one hundred and twenty million (120,000,000) live iPS cells from a given donor sample at any one time to conduct the above activities.

Notwithstanding the above, the commercialization of any identified drug candidate from the above activities by an academic purchaser requires a commercial license from Cellular Dynamics International, Inc.

Academic purchasers may transfer the iPS cells and their derivatives thereof to third parties for internal research purposes; provided however, that (i) if the third party is a commercial entity, then such commercial entity transferee must agree to be bound by the terms and use restrictions of this Limited Use Label License applicable to commercial purchasers (any additional use by such commercial transferee shall require a commercial license from Cellular Dynamics International, Inc.); and (ii) all recipients will be provided with a copy of this Limited Use Label License and will be subject to the applicable use and transfer restrictions . Academic purchasers who seek to obtain additional use, commercial or therapeutic rights of the product, the iPS cells or their derivatives thereof may contact Cellular Dynamics International, Inc. at support@cellulardynamics.com.

The following restrictions apply to both commercial and academic purchasers:

No right to resell this product or any of its components, the iPS cells generated by use of the product, or their derivatives thereof is conveyed expressly, by implication, or by estoppel. Notwithstanding the limited rights to transfer the iPS cells and their derivatives as permitted above, no purchaser of this product or permitted transferee may deposit or otherwise provide iPS cells originally generated by use of this product, or any derivatives of such iPS cells, to any biobank or any other organization or entity that intends to distribute such iPS cells or derivatives, unless such biobank or entity is authorized by Cellular Dynamics International, Inc. specifically for such purpose and the purchaser or permitted transferee notifies Cellular Dynamics International, Inc. of the deposit of the iPS cells or their derivatives. The rights to the technologies embodied in this product are owned by Cellular Dynamics International, Inc. and its licensors. No other rights are conveyed to any other intellectual property owned or controlled by Cellular Dynamics International, Inc., including without limitation its patented and/or proprietary methods for differentiation of the iPS cells.

Notice to Purchaser: The transfer of this product conveys to the recipient user the limited, non-transferable right to use the transferred amount of product to perform internal research for the sole benefit of the recipient user and for educational purposes. No right to resell this product or any of its components, or iPS cells generated by use of the product, or modifications (progenitors or fully differentiated cells) thereof is conveyed expressly, by implication, or by estoppels. This product, iPS cells made using this product and their modifications shall not be administered to - (a) human subjects, including for human clinical use and/or (b) animals for veterinary use (i.e., not for research) – for therapeutic, diagnostic or prophylactic purposes including but not limited to clinical applications, cell therapy, transplantation and/or regenerative medicine, nor shall be used for the creation of human embryos, and/or admixed embryos with embryos of animals including humans for any purpose including for research. This product, iPS cells made using this product and their modifications is for internal research purposes and is not for use in any of the following commercial applications: (i) use of iPS cells and progeny (but not modifications) for manufacture or quality control of any product; (ii) use of cells to provide a service, information or data to a third party for financial gain (financial benefit exceeds the cost of operating the transaction), except when performed by a not-for-profit research entity (not affiliated with a for-profit organization) not for financial gain, or performed on behalf of a third party having an appropriate license*; (iii) use of cells by or on behalf of recipient user for screening or later stage development of therapeutics, diagnostics, prophylactics (e.g., hit-to-lead, lead optimization), except when performed by or on behalf of a not-for-profit research entity for internal research and not for financial gain, or when performed in accordance with a separate Limited Sub License Agreement for use of LTC Pluripotent Cells executed in writing between recipient user and LTC; (iv) sale, lease distribution, transfer or license of cells to third parties for financial gain; (v) any sale, lease, distribution, transfer or license of iPS cells and progeny (but not modifications) by recipient user to for-profit entities, even if for research use. Any person or entity that wishes to perform commercial applications described above using this product, iPS cells derived from the use of this product, or modifications thereof, is required to take a license to cover the appropriate commercial application. An entity that wants to transfer iPS cells or progeny to a for-profit recipient shall notify the for-profit recipient that such recipient is required to take the appropriate license to use the materials for internal research of any type.

Notwithstanding the foregoing, the following activities are not considered commercial applications for purposes of this label license:

(a) basic research, including, without limitation, target discovery, target validation and assay development;
(b) transfer of cells to not-for-profit research entity for its internal research not for financial gain;
(c) compound screening and safety testing for development of therapeutics, diagnostics and prophylactics by academic and not-for-profit research entities for their non-commercial internal research;
(d) license or commercialization of research results except where such results are drugs or drug candidates, iPS cells or modifications, or where such license or commercialization uses iPS cells or progeny;

Other than rights granted herein, no other right, express or implied, is conveyed by the sale of this product. *For information on obtaining additional rights, please contact outlicensing@thermofisher.com, Licensing and Commercial Supply, Thermo Fisher Scientific, 5823 Newton Drive, Carlsbad, CA, 92008, United States. Notice: If iPS cells and derivatives (hereafter “Materials”) generated by use of this product are transferred to other users in accordance with the terms of the label license for reprogramming technology set forth above and accompanying the product (hereafter “Label License”), the transferring party should notify the recipients of such Materials of these terms by transferring a copy of the Label License to the recipients.