LICENSE AGREEMENT AND TERMS AND CONDITIONS OF SERVICE: IPSCs

Summary

By purchasing induced pluripotent stem cells, an induced pluripotent stem cell line and each of their modifications, including but not limited to derivatives or differentiated progeny (“iPSC”) from STEMCELL Technologies Inc., the STEMCELL Group of Companies and each of its subsidiaries and affiliates (hereinafter referred to as “STEMCELL”), you are entering a legally binding agreement that obligates you to pay an annual fee and limits some of your rights. This agreement describes the limitations on how you may use the iPSCs you purchase, the fees for use, and other terms and conditions. If you have any questions, you may contact iPSCrequests@stemcell.com.

This agreement for the sale and use of iPSCs and corresponding intellectual property (“Agreement”) shall govern all such purchases made from STEMCELL as of the date of purchase (the “Effective Date”) by you, the purchaser (“you”,”your”). Collectively, you and STEMCELL may be referred to as the “Parties”, and each of you and STEMCELL as a “Party”.

The “STEMCELL Group of Companies” shall mean: STEMCELL Technologies Canada Inc., STEMCELL INTERNATIONAL INC., STEMCELL TECHNOLOGIES (AUSTRALIA) HOLDINGS PTY LTD, Stemcell Technologies Singapore Pte. Ltd., Stemcell Technologies UK Ltd., STEMCELL Technologies China Co. Ltd., Stemcell Technologies Inc., STEMCELL TECHNOLOGIES SARL, STEMCELL Technologies Germany GmbH, Stemcell Technologies Netherlands B.V., and such other companies as may be added or removed from time to time.

1. Background

  1. This Agreement supplements STEMCELL’s standard terms and conditions, as described below in section 4.
  2. STEMCELL has secured the rights to use, sell, and license to you the use of certain iPSCs for limited uses as set out below.
  3. The iPSCs that you purchase from STEMCELL carry more restrictions and obligations than most standard products in our catalog. The iPSCs are for limited uses, carry annual fees, and carry additional terms and conditions beyond those that apply to most other purchases from STEMCELL.
  4. Because different organizations or persons hold different rights related to the iPSCs, it is important that the rules for the use of the products are followed carefully. Failure to adhere to this Agreement and the terms and conditions referenced herein may result in intellectual property infringement. STEMCELL will not be liable if you infringe intellectual property rights.
  5. By purchasing iPSCs from STEMCELL, you agree that you are the purchaser or an authorized agent of the purchaser with the authority to bind the purchaser to this agreement.
  6. By selling iPSCs to you, STEMCELL is only granting you the non-exclusive rights to use the iPSCs in accordance with the Restricted Use set out in section 2 below, and for no other purpose. The rights granted to you are contingent on the timely payment of the applicable fees set out in section 3 below. Failure to pay these fees on time will immediately terminate your rights.

2. Restricted Use

  1. Notwithstanding anything to the contrary in this Agreement, iPSCs shall not be used or administered in (1) human subjects for human clinical use; (2) animals for veterinary use for therapeutic, diagnostic or prophylactic purposes; or (3) any subject in relation to, without limiting the generality of the foregoing, clinical applications, cell therapy, transplantation, and/or regenerative medicines.
  2. iPSCs may not be used for monetization or commercialization purposes unless you obtain an additional license outside of this Agreement that permits use for these purposes. Monetization or commercialization purposes include, without limitation, the use to perform services or supply products or rights, including in the manufacture of cellular therapies or other therapeutics, for monetary gain or the generation of royalties, revenues, sales or other valuable consideration. For clarity, iPSCs may not be used, without obtaining an additional license outside of this Agreement, for screening compounds, antibodies, proteins or peptides, except for the purposes of target discovery, target validation, or assay development.
  3. It may be possible to obtain a further license for the prohibited uses referred to in section 2(2). Please contact iPS Academia Japan Inc. for more details on obtaining a license for screening compounds, antibodies, proteins or peptides. Please contact iPSCrequests@stemcell.com for more details on obtaining a license for other commercial uses.
  4. PRODUCTS ARE FOR RESEARCH USE ONLY AND NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES UNLESS OTHERWISE STATED.
  5. The iPSCs purchased under this Agreement are for use by one customer to perform internal research at up to 3 geographical sites. It is the customer’s responsibility to ensure that any transfer of the iPSCs to other geographical sites are in compliance with all applicable laws and regulations. STEMCELL shall not be liable, under any circumstances, for such transfers. For permission to transfer the iPSCs for use at a different organization, research group, or similar entity, you must contact iPSCrequests@stemcell.com. Notwithstanding the foregoing, or any language to the contrary, STEMCELL makes no representations or warranties as to whether the possession, use or other handling of the iPSCs within a particular geographical site or transfer to or from a particular geographical site is in compliance with all applicable laws or regulations. For permission to expand the use to 4 or more geographical sites, you must pay the Global Annual License Fee set out in Schedule 1 to this agreement. Additional fees may apply for such permissions.

3. Fees

  1. One-time purchase fee: each iPSC cell line that you purchase from STEMCELL will require the payment of the purchase price listed or quoted to you. This is payable at time of purchase.
  2. Annual license fee: in addition to the purchase fee above, for each iPSC cell line that you purchase, you will be charged an annual license fee as described in Schedule 1 of this agreement (“Annual License Fee”), which is subject to any further fees or taxes that apply, and which is billed and due at the time of purchase, being the Effective Date, and billed and due again at each anniversary of the Effective Date. The Annual License Fee is payable in full each year unless this agreement is terminated in accordance with section 7 or 8.
  3. Changes to Annual License Fee: STEMCELL may, at its sole discretion, change the Annual License Fee at any time by providing notice to you. If STEMCELL provides notice of a change to the Annual License Fee more than 60 days before the next anniversary of the Effective Date, then the new Annual License Fee shall take effect and be due on that next anniversary. If STEMCELL provides notice of a change to the Annual License Fee less than 60 days before the next anniversary of the Effective Date, then the new Annual License Fee will not take effect until one year after the next anniversary. For clarity, you will always have at least 60-days notice of a price change becoming effective. You also have the right to terminate this Agreement if you disagree with the price change, only as set out in section 7(5).
  4. Maximum license fee: the maximum total Annual License Fee under this agreement for all iPSC cell lines you purchase is four times the Annual License Fee per year per customer. For clarity, if you purchase 5 or more iPSC cell lines, the annual fee is capped at four times the applicable Annual License Fee listed in Schedule 1.
  5. Non-profit use: on a case-by-case basis, non-profit users such as public universities may be granted an exemption from the Annual License Fee or a reduced Annual License Fee. To request this, speak to your sales representative or contact iPSCrequests@stemcell.com.

4. Other Terms and Conditions

STEMCELL’s standard “TERMS AND CONDITIONS OF SERVICE RELATED TO ALL PRIMARY CELL PRODUCTS (All Products containing Primary and Cultured Cells)” (“Standard Terms”) found at [https://www.stemcell.com/terms-and-conditions-general] apply to iPSC purchases and are incorporated herein. This Agreement and the Standard Terms are meant to apply with equal force, with this Agreement supplementing the Standard Terms. However, to the extent there is a conflict between the Standard Terms and this Agreement, this Agreement shall prevail and take priority, unless it is unenforceable, in which case the Standard Terms shall apply.

5. Warranties, Limited Liability, and Indemnity

WARRANTY

  1. Primary cell products supplied by STEMCELL, including these iPSCs, are warranted to meet the specifications provided on our Product Information Sheets and/or Certificates of Analysis when used under normal conditions in your laboratory for a period expiring twelve months after the date of their delivery. Should any primary cell product fail to perform as specified during the warranty period (the “Product Warranty Period”), STEMCELL will credit the purchase price of the Services in relation to the nonconforming primary cell product to the Purchaser’s account or replace the primary cell product free of charge. This warranty is exclusive and limits our liability to the replacement of the primary cell product or, at our option, full credit of the original purchase price of the Services in relation to the primary cell product. ANY PRODUCT OR SERVICE NOT COVERED BY AN EXPRESS WRITTEN WARRANTY IS SOLD “AS IS”, WITHOUT REPRESENTATION, WARRANTY OR CONDITION OF ANY KIND, EXPRESS OR IMPLIED. A warranty will not apply to a primary cell product that fails to perform its specific function due to misuse, improper storage, use beyond expiry date or accidental damage.

DISCLAIMER

  1. THIS LIMITED WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY PROVIDED BY STEMCELL IN CONNECTION WITH THE PRODUCT AND IS, WHERE PERMITTED BY LAW, IN LIEU OF ALL OTHER WARRANTIES, CONDITIONS, GUARANTEES AND REPRESENTATIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE IN CONNECTION WITH THE PRODUCT, HOWEVER ARISING (WHETHER BY CONTRACT, TORT, NEGLIGENCE, PRINCIPLES OF MANUFACTURER'S LIABILITY, OPERATION OF LAW, CONDUCT, STATEMENT OR OTHERWISE), INCLUDING, WITHOUT RESTRICTION, ANY IMPLIED WARRANTY OR CONDITION OF QUALITY, MERCHANTABILITY, MERCHANTABLE QUALITY, DURABILITY, TITLE, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE. ANY IMPLIED WARRANTY OR CONDITION OF QUALITY, MERCHANTABILITY, MERCHANTABLE QUALITY, DURABILITY, TITLE, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE, TO THE EXTENT THAT IT CANNOT BE EXCLUDED UNDER APPLICABLE LAW, WILL BE LIMITED IN DURATION TO THE WARRANTY PERIOD STIPULATED UNDER THE ABOVE LIMITED WARRANTY.
  2. IN NO EVENT WILL STEMCELL BE LIABLE FOR ANY SPECIAL, DIRECT, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES, LOSSES, COSTS OR EXPENSES, LOST PROFITS, FAILURE TO REALIZE EXPECTED SAVINGS, ANY ECONOMIC LOSSES OF ANY KIND, ANY LOSS OR DAMAGE TO PROPERTY, ANY PERSONAL INJURY, ANY DAMAGE OR INJURY ARISING FROM OR AS A RESULT OF MISUSE OR ABUSE, OR THE IMPROPER STORAGE, USE BEYOND EXPIRATION DATE, ACCIDENTAL DAMAGE TO THE PRODUCT OR ANY COSTS ARISING FROM THE USE, THE RESULTS OF USE, OR THE INABILITY TO USE, THE PRODUCT, OR OTHERWISE ARISING OUT OF OR RELATED TO THE SERVICES OR THIS CONTRACT, HOWEVER ARISING (WHETHER IN CONTRACT, TORT, NEGLIGENCE, PRINCIPLES OF MANUFACTURER'S LIABILITY, OPERATION OF LAW, CONDUCT, STATEMENT OR OTHERWISE).

    IF YOU HAVE AN ISSUE WITH THIS PURCHASE, THE IPSCS, THIS CONTRACT, OR STEMCELL, YOUR ONLY RECOURSE IS A REFUND OF THE FEES YOU HAVE PAID TO STEMCELL UNDER THIS AGREEMENT, AT MAXIMUM, EVEN IF YOU LOSE MORE THAN THAT.

INDEMNITY

  1. Purchaser shall, at your own expense, indemnify, defend and hold STEMCELL, its directors, officers, employees, agents, successors and assigns (“STEMCELL Indemnitees”), harmless from and against any and all losses, costs, damages and expenses (including, reasonable attorneys’ fees and other costs of defending any action) (collectively, “Losses”) that we may incur in any way arising out of or relating to (a) any breach by you of your obligations under this Contract, (b) any use of the primary cell products not in compliance with the uses stated in the Product Information Sheets, (c) any failure of you to comply with good laboratory practice, laws, regulations, guidelines or decisions in the handling or use of the primary cell products, (d) any violation or infringement of any patent, trade secret, copyright, trademark, industrial design, licenses, or other intellectual or proprietary rights (“Intellectual Property Rights”) of a third party by you in the handling or use of the primary cell products, or (e) any other use or misuse of the primary cell products by you including without limitation any claim of product liability or any similar claim relating to the quality of the products or an alleged defect or deficiency in the products.

6. Sublicensing and Sharing Prohibited

  1. You may not, without express written permission from STEMCELL, grant or assign the rights to use the iPSCs to anyone else or share the foregoing or the rights granted to you with anyone else except as permitted in this Agreement.

7. Terminating and Suspending This Agreement

  1. Either Party may only Terminate this Agreement for any reason, with or without cause, with 60 days’ written notice to the other Party.
  2. In any event, the rights granted to you to use the iPSCs will terminate 60 days after either Party gives a termination notice (the “Termination Date”), and you shall destroy the iPSCs on or before the Termination Date and, upon STEMCELL’s request, provide STEMCELL with written confirmation of their destruction.
  3. If you give notice to terminate this Agreement more than 60 days before the next anniversary of the Effective Date, no further Annual License Fees will become due. In any event, any Annual License Fees already paid are non-refundable if you terminate the Agreement.
  4. If you give notice to terminate this Agreement less than 60 days before the next anniversary of the Effective Date, the next Annual License Fee shall still be due and payable on the anniversary date. For clarity, you cannot terminate this Agreement less than 60 days before the next anniversary of the Effective Date without paying a penalty equivalent to the Annual License Fee due on that anniversary.
  5. If STEMCELL elects to change the Annual License Fee in accordance with section 3(3), then you may terminate this Agreement within 10 business days of receiving the notice of change of the Annual License Fee, by providing written notice to STEMCELL. Such termination shall be effective at the next anniversary of the Effective Date, notwithstanding the 60-day notice requirements in this Agreement. For clarity, you have a 10 business day window to cancel the agreement without penalty if STEMCELL changes the Annual License Fee, even if this occurs within 60 days before the next anniversary of the Effective Date. If you do not give notice of termination within 10 business days of receiving STEMCELL’s notice of change to the Annual License Fee, then you shall be deemed to have accepted the new Annual License Fee and you lose your right to terminate this Agreement without penalty.
  6. If STEMCELL terminates the Agreement, the proportion of the Annual License Fee already paid corresponding to the period between the Termination Date and the next anniversary of the Effective Date shall be refunded.
  7. If the Parties agree in writing, this Agreement may be suspended for any amount of time. During the suspension period, Annual License Fees will not be payable, but you will be required to store but not use the iPSCs. For any suspension period that starts or ends on a day other than an anniversary of the Effective Date, the Annual License Fee will be prorated such that you only pay for the portion of time that you have the right to use the iPSCs. To arrange to suspend the Agreement, contact iPSCrequests@stemcell.com.

8. Changes to this Agreement

STEMCELL may from time to time change this Agreement and the Terms and Conditions that accompany this Agreement by providing you 60 days written notice of the change. If you do not refuse the changes in writing within 10 business days of receiving the notice of changes from STEMCELL, you shall be deemed to have accepted the changes. If you do not accept the changes, you must notify STEMCELL in writing within 10 days of receiving notice of the changes that you refuse the changes (the “Refusal Notice”). If you choose to decline the changes, this agreement will terminate 60 days after you provide Refusal Notice and you will be refunded the portion of the last Annual License Fee that you paid corresponding to the time remaining after termination of this Agreement but before the next anniversary of the Effective Date.

SCHEDULE 1

Annual License Fees referred to in section 3 of this agreement vary by jurisdiction as follows:

Jurisdiction
Currency
Fee
Australia
AUD
7,000.00
Benelux
EUR
4,500.00
Canada
CAD
6,500.00
China
CNY
France
EUR
4,500.00
Germany
EUR
4,500.00
Ireland
EUR
4,500.00
New Zealand
AUD
7,700.00
Scandinavia
EUR
4,500.00
Singapore
SGD
7,500.00
Spain
EUR
4,500.00
Sweden
SEK
49,500.00
United Kingdom
GBP
4,000.00
United States
USD
5,000.00

The prices in the table above are for an Annual License Fee that allows the use of the IPSCs at up to 3 geographical locations by one customer. For permission to use the IPSCs at 4 or more geographical locations, a Global Annual License Fee equal to double the applicable fee in the table above must be paid. The Global Annual License fee is a type of Annual License Fee for the purposes of this Agreement.All fees and prices herein are subject to additional taxes and fees, if applicable.