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Standard Terms and Conditions

Terms for Material Transfer and Use of Materials

The following terms use “you” to refer to you, the customer placing the order, as well as your organization where you are employed or which you represent, and anybody else carrying out work on behalf of you or your organization, including employees, contractors, and/or consultants.

These terms include those set forth below and those set forth in Schedule I and Appendix I attached hereto.

These terms apply whenever you place an order with Trailhead Biosystems Inc. for Materials (as defined below). By placing an order for Materials, you agree to these terms, including those set forth below and those in Schedule I and Appendix I hereto.  Trailhead Biosystems Inc. is referred as “we” or “us” in these terms.

You may place an order with us for Materials in one of the following ways: (1) from our website at the following URL: www.trailbio.com/cells using our online order process, or (2) by submitting a written order to us for Materials that incorporates these terms but no other terms and that we accept in writing.  We explicitly reject and exclude any other order and any other terms included or submitted with an order, whether additional terms or terms that are different from the terms below or from the terms in Schedule I or Appendix I hereto.

The Materials

The term “Materials” as used in these terms means the original materials ordered by you that we deliver, including biological cells, media for growing cells, and anything else we deliver as part of your order.

The term “Materials” as used in these terms also includes all of the following:

(1) any biological cells that you make or generate or reproduce from any of the original Materials delivered by us to you, whether by expansion, cell differentiation, modification, culturing, procreation, propagation, proliferation, genetic modification, or otherwise, and any progeny thereof,

(2) any biological cells that you make or generate or reproduce from any of the Materials described in clause (1) above, whether by expansion, cell differentiation, modification, culturing, procreation, propagation, proliferation, genetic modification, or otherwise, and any progeny thereof,

(3) any modifications or improvements of any of the original Materials delivered by us to you or any of the Materials described in clauses (1) or (2) above,

(4) the original culture media or media formulations or any other substances or compositions of matter delivered by us to you, and

(5) any reproduction, copies, modifications, of improvements of the original culture media or media formulations or any other substances or compositions of matter delivered by us to you.

Delivery; Inspection; Payment

We will deliver the Materials you order to the address you provide, using our standard delivery times. Delivery will be with a carrier and packaging of our choice and at your expense and your risk of loss (ex works Incoterms 2020).

When you receive Materials, you have 15 business days to inspect them and make sure they match your order. If they do not match, you must let us know before this 15-business day period ends; otherwise, you will be deemed to have accepted the Materials.

If we agree the Materials do not match your order, we will either replace them or refund you the use fees you paid, at our option, and will either require you to destroy or return the non-conforming Materials; if returning, the return will be at our cost. You will not use any of these non-conforming Materials. Non-conformity of Materials caused by your own storage, use, delivery, or other actions does not count and will not entitle you to a refund or replacement.

You must pay for the use of the Materials within 30 days of receiving our invoice, which we will send to the address or email address you provide with your order after the Materials are shipped. You are responsible for all taxes, fees, and shipping costs.

Ownership

We exclusively own and retain all right, title, and interest in and to Materials at all times, including after we transfer possession of the Materials that you ordered to you or to an authorized contractor on your behalf. We also own any Materials that were created or developed by you or on your behalf or while in your possession or under your control.

At the end of the period of your permitted use of the Materials as provided below, or when you are in breach of these terms, including Schedule I or Appendix I hereto, you must deliver to us or, at our option, promptly destroy all of the Materials.

You acknowledge that we have no obligation to disclose to you the composition or components of any Materials or any data related to their use or testing.

How You May Use Materials

You may only use the Materials for your internal research that complies with these terms, including, but not limited to, Appendix I, and that involves using or differentiating the Materials that are biological cells according to the cell-specific use terms set forth on Schedule I.

For clarity, your use and disposition of the Materials is limited by these terms, including those set forth on Schedule I and Appendix I.  You will not allow the use or disposition of the Materials in in violation of these terms, including those set forth on Schedule I and Appendix I.

You may not use the Materials for any purpose whatsoever in humans.

Permitted uses of the Materials include pre-clinical testing, including in vivo testing in non-human animals, drug discovery and development, and internal evaluation that otherwise comply with these terms.

You may not use the Materials for therapeutic, prophylactic, diagnostic, or curative uses for non-human animal diseases or the prevention of non-human animal diseases or other veterinary purposes.

You may not use the Materials in non-human animals for nutritional purposes.

You may not use the Materials in non-human animals for developing or testing cosmetics or non-therapeutic substances.

The only permissible use of Materials in non-human animals is pre-clinical or non-clinical testing that is consistent with all other terms hereof, compliant with all applicable laws and regulations, and approved by any applicable review boards.

You may not sell, redistribute, lease, bail, consign, or transfer any Materials.

You may not expand any Materials without our written consent, except as specifically permitted in Schedule I hereto. You may not make any progeny, copies, modifications, or improvements to the Materials without our written consent, except as specifically permitted in Schedule I hereto.

Except as specifically permitted in Schedule I, you may not develop or differentiate any biological cells from, or make any modifications or improvements to, Materials, unless we explicitly agree in writing to such use.

You may not try to determine how any Materials are made, and you may not analyze the composition of matter of any non-cell materials, such as cell culture media, that are part of the Materials.

You may not use any Materials to develop any protocol or formula for making Materials or any biological cells of substantially the same type as any Materials or any culture media of substantially the same type as any Materials.

You must keep all Materials on your premises or at an approved contractor’s location. You must use reasonable security measures to prevent theft, loss, or unauthorized access to Materials. You must comply with all applicable laws in storage and handling of Materials. You cannot remove the Trailhead logo or other branding from any containers storing the Materials.

If you use a contractor to assist with your research, you are responsible for ensuring they comply with these terms, including those set forth in Schedule I and Appendix I. You may only use contractors approved in writing by us.

You may only make Materials available to your qualified employees or approved contractors who need to use the Materials for your research.

You may not use any Materials to develop or make any biological cell for which you seek or obtain patent protection, whether by claiming any manufacturing method, composition of matter, modification, improvement, or use.

You may not use any Materials to seek or obtain patent protection for any use in humans or non-human animals of any of the Materials or any biological cells that are substantially similar to any Materials.

You may not use any Materials to seek or obtain patent protection for any diagnostic, treatment, cure, or prevention of any disease or injury that involves or claims any of the Materials or any biological cells that are substantially similar to any Materials.

By placing an order for the Materials, you also agree to comply with the additional terms of Annex I, which are required by our upstream licensor, iPS Academia Japan Inc.

Limited License

We grant you a limited non-exclusive right and license to use Materials solely as provided in these terms until you are required to deliver to us or destroy the Materials as further provided below. We do not grant any other rights or ownership or license in or to any Materials, their related data, or any protocols.

Nothing in these terms will be construed as granting you any other rights in or to any Materials or under any trade secrets, copyrights, patent applications, or patents.

You agree to use, maintain, and dispose of the Materials only as permitted in these terms and not to exceed the scope of the limited license granted to you.

You hereby assign and transfer to us any and all rights, title, ownership, and interest in and to, any of the following, which are referred to herein as “Prohibited Inventions”: (1) all Materials and all inventions, whether or not patentable, that are created or made in violation of this Agreement and (2) all related patents and patent applications and all related priority rights and any and all other related intellectual property rights. This assignment and transfer is in addition to the remedies that may be available to us at law, in equity, or otherwise.

If, for any reason, you retain any right, title, or interest in and to the Prohibited Inventions, you hereby (i) grant us a perpetual, irrevocable, fully paid-up, royalty-free, freely transferrable, sublicensable (through multiple levels of sublicensees), exclusive (including exclusive as to you), worldwide right and license under any and all patents and other intellectual property rights to practice and otherwise exploit, including through use, sale, offer for sale, making, importing, modifying, and improving any and all Prohibited Inventions, (ii) agree, at our request and expense, to consent to and join in any action to enforce the rights granted in this paragraph, (iv) agree to, before abandoning any patent or patent application that claims a Prohibited Invention in whole or in part, first notify us and, upon our request, assign each patent and patent application claiming a Prohibited Invention, and all related priority rights, to us in consideration for payment of $1.00.

You will promptly notify us of any Prohibited Invention and will not use or disclose any Prohibited Invention to any other person or entity except as required in connection with patent prosecution of the Prohibited Invention.  You will promptly deliver all Prohibited Inventions in tangible form to us.

Disclaimer of Warranties

The Materials are experimental and provided “as is.” We make no representations or warranties, express or implied, about their performance, accuracy, safety, or anything else. To the fullest extent permissible by law, we disclaim all warranties, whether express, implied, or statutory, and specifically disclaim all implied warranties of merchantability, fitness for a particular purpose, title, and non-infringement of third-party rights and industry certifications, and all warranties arising from course of dealing, usage or trade practice.

Limitation of Liability

Neither we nor any of our affiliates, officers, directors, employees, agents, licensors, or suppliers shall have liability for consequential, exemplary, enhanced, special, incidental, indirect, punitive or statutory damages, or any multiples of direct damages, under any legal theory of any kind, including, but not limited to, contract, negligence, or warranty, with respect to obligations under any order or these terms or otherwise. These exclusions liability apply regardless of whether a person was advised of the possibility of such losses or damages, or such losses or damages were otherwise foreseeable, and notwithstanding the failure of any agreed or other remedy of its essential purpose.

To the maximum extent permitted by law, in no event shall our aggregate liability, including that of our affiliates, stockholders, officers, directors, employees, agents, and suppliers, whether arising out of or related to breach of contract, tort (including, but not limited to, negligence), statute, or otherwise, to you or any other person exceed the total of the amounts paid to us by you under the applicable order.

Use Termination

You may use the Materials subject to and as limited by these terms for a period of 24 consecutive months from the date you placed your order with us, unless your use rights terminate sooner because you have materially breached any part of these terms or you timely rejected the Materials as provided above.

If you materially breach any part of these terms, including as set forth in Schedule I and Annex I hereto, or you timely reject the Materials as provided above, your right to use any of the Materials ends immediately.

When your rights to use the Materials ends, all rights and licenses granted to you under these terms will automatically terminate, and you must stop using all Materials and either deliver all Materials to us or, at our option, destroy all Materials as we direct, with confirmation of such delivery or destruction sent to sales@trailbio.com and legal@trailbio.com.  Except for your license and rights to use the Materials, these terms continue to apply.

Other Provisions

In addition to any other rights or remedies available to us at law or equity or otherwise, you agree that we can seek injunctive relief to enjoin any breach or violation, or seek specific performance of the provisions of the order or these terms, including those set forth in Schedule I and Appendix I attached hereto, without having to post any bond or security (or if a bond or security is required, not to require a bond or security in excess of $1,000) or to prove actual damages or that monetary damages are not an adequate remedy.

These terms including Schedule I and Appendix I attached hereto, and your order comprise the entire agreement between us, and supersedes all other communications relating to the subject matter, other than any non-disclosure agreement between you and us, which will continue in full force and effect. We and you are not bound by any modification or amendment, including without limitation any quote or similar document, unless in writing and signed by you and us. In the event you deliver any order or similar document that sets forth, includes, or references other terms, these other terms will be excluded and be of no force and effect and only these terms will govern.

From time to time, we mention our customers in marketing and communications initiatives. We may use your name and/or logo in marketing materials, but you have the right to ask us to remove your name or logo.

We and you are independent contractors and not partners or joint venturers. We do not owe you any fiduciary duty.

You may not transfer or assign any rights under this Agreement to any other person or entity without our written permission, except where you are selling all or substantially all of your business relating to this Agreement. This Agreement will be binding upon all of your successors and assigns. There are no intended third-party beneficiaries.

These terms are severable. If any provision is unenforceable, illegal, or invalid, then the remainder will continue in full force and effect.

Failure by us or you to enforce or require performance of any provision will not be construed as a present or future waiver of that provision and will not adversely affect that party’s right to enforce each provision in the future.

Any notices will be directed by e-mail to the addresses listed for both parties in your order. For clarity, for us this will be sales@trailbio.com and legal@trailbio.com.

The laws of the State of Delaware (USA) governs the order placed by you with us, including these terms and those set forth in Schedule I and Appendix I attached hereto, without giving effect to any choice or conflict of law provisions that would require other jurisdictions’ laws to apply.

You are responsible for compliance by your affiliates, employees, directors, officers, managers, agents, representatives, consultants, advisors, and contractors with your obligations under the order and these terms, including as set forth in Schedule I and Appendix I attached hereto, and you will be deemed to be in breach of the order and these terms if any of your persons are not in compliance with the order or these terms.

You hereby irrevocably waive any and all rights you may have, now or in the future, to have any controversy or claim between us and you, arising out of or relating to the order or these terms or any transaction contemplated by this order or related thereto, including without limitation any claim based on or arising from an alleged tort or statutory violation, be heard or decided by a jury in a trial.

 

[Schedule 1 follows]

Schedule I

Cell-Specific Use Restrictions

  1. TrailBio® Pre-Myelinating Oligodendrocytes Cell Kit

The TrailBio® pre-myelinating oligodendrocytes cell kit contains a vial or vials of TrailBio® oligodendrocyte progenitor-like cells that may only be differentiated into pre-myelinating oligodendrocyte-like cells using the cell culture media, supplements, and applicable protocols provided in the TrailBio® pre-myelinating oligodendrocytes cell kit.

The cell culture media provided in the TrailBio® pre-myelinating oligodendrocytes cell kit may only be used to differentiate the TrailBio® oligodendrocyte progenitor-like cells into pre-myelinating oligodendrocyte-like cells using the applicable protocols provided with the TrailBio® pre-myelinating oligodendrocytes cell kit.

  1. TrailBio® Endothelial Cell Kit

The TrailBio® endothelial cell kit contains a vial or vials of TrailBio® endothelial-like cells which may only be maintained in culture using the cell culture media provided in the TrailBio® endothelial cell kit and the applicable  user protocols provided with the TrailBio® endothelial cell kit.

The cell culture media provided in the TrailBio® endothelial cell kit may only be used by or on behalf of Customer to maintain the TrailBio® endothelial-like cells using the applicable user protocols provided with the TrailBio® endothelial cell kit.

  1. TrailBio® PVALB+ Interneurons Kit

The TrailBio® parvalbumin+ interneuron cell kit contains a vial or vials of TrailBio® parvalbumin+ interneuron progenitor-like cells that may only be differentiated into parvalbumin+ interneuron-like cells using the cell culture media and applicable protocols provided in the TrailBio® parvalbumin+ interneuron cell kit.

The cell culture media provided in the TrailBio® parvalbumin+ interneuron cell kit may only be used by or on behalf of Customer to differentiate the TrailBio® parvalbumin+ interneuron progenitor-like cells into parvalbumin+ interneuron-like cells using the applicable protocols provided with the TrailBio® ® parvalbumin+ interneuron cell kit.

  1. TrailBio® SST+ Interneurons Kit

The TrailBio® SST+ interneuron cell kit contains a vial or vials of TrailBio® SST+ interneuron progenitor-like cells that may only be differentiated into SST+ interneuron-like cells using the cell culture media and applicable protocols provided in the TrailBio® SST+ interneuron cell kit.

The cell culture media provided in the TrailBio® SST+ interneuron cell kit may only be used to differentiate the TrailBio® SST+ interneuron progenitor-like cells into SST+ interneuron-like cells using the applicable Protocols provided with the TrailBio® SST+ interneuron cell kit.

  1. TrailBio® Dopaminergic Neurons Media Kit

The TrailBio® Dopaminergic Neurons kit contains a vial or vials of TrailBio® dopaminergic neuron progenitor-like cells that may only be differentiated into dopaminergic neuron-like cells using the cell culture media, supplements, and applicable protocols provided in the TrailBio® dopaminergic neurons cell kit.

The cell culture media provided in the TrailBio® dopaminergic neuron cell kit may only be used to differentiate induced pluripotent stem cells into dopaminergic neurons using the applicable user protocols provided with the TrailBio® dopaminergic neurons cell kit.

  1. ME-03-05 TrailBio® Hematopoietic Progenitor Cells Kit

The TrailBio® hematopoietic progenitor-like cells may only be expanded and differentiated into erythrocyte-like cells.

  1. TrailBio® Hepatocytes Kit

The TrailBio® hepatocyte-like cell kit contains a vial or vials of TrailBio® hepatocyte-like cells may only be differentiated into hepatocyte-like cells using the cell culture media, supplements, and applicable protocols provided in the TrailBio® hepatocytes kit.

The cell culture media provided in the TrailBio® hepatocyte-like cell kit may only be used to recover the TrailBio® hepatocyte-like cells using the user protocols provided with the TrailBio® hepatocytes kit.

[End of Schedule I]

Annex I

User Restrictions

Definitions:

  1.           Trailhead: Trailhead Biosystems Inc.
  2.           iPS-AJ: iPS Academia Japan, Inc.
  3.           Product: Cells which are partially or terminally differentiated from iPS cells by Trailhead, and which Trailhead sells or transfers under the license agreement between iPS-AJ and Trailhead
  4.           User: Person or entity who received Product from Trailhead

User Restrictions:

  1.           User may use Product for its internal research, including but not limited to screening potential drug compounds for efficacy and safety, and for the provision of services to third parties. No other right is granted to User whether expressly, by implication, by estoppel or otherwise.  User’s internal research includes further differentiating the Product and non-clinical and preclinical research activities using the Product for internal research purpose.
  2.           User agrees to use Product in compliance with all applicable statutes and regulations, but not to use Product for any administration or application to humans. Moreover, User agrees not to use Product for humans or animals for therapeutic, diagnostic or prophylactic purposes, the use including, but not limited to, clinical applications, cell therapy, transplantation and regenerative medicine without an appropriate license.
  3.           User may transfer Products to a third party, provided that in such transfer, User shall convey the User Restrictions set forth herein to such third party.
  4.           In particular, no other right or license to use, develop or otherwise exploit Product commercially are granted to User, and no rights are conveyed to User to use Product for any other purpose.
  5.           These User Restrictions are in addition to any other terms, conditions, or restrictions that Trailhead may impose with respect to a Product.

 

Trailhead Biosystems Inc.

Address:  23215 Commerce Park Road, Beachwood, Ohio 44122 USA

E-mail:  dtrivedi@trailbio.com and legal@trailbio.com

 

[End of Annex 1]