Standard Terms Conditions

These Standard Terms and Conditions, including Annex 1 thereto, as set forth in this document (the “Standard Terms”) shall apply to and govern any order placed by a Customer (as identified in such order) with Trailhead Biosystems Inc., a Delaware corporation, (“Trailhead”), for the transfer, possession, and use of the Trailhead Materials that are the subject of such order, to which these Standard Terms are attached as Appendix A or in which they are specifically referenced and which is signed by both Trailhead and the Customer (“Order”). Placing such Order with Trailhead constitutes Customer’s agreement to the Standard Terms set forth herein, as such Standard Terms may have been updated through the date of such Order. “Special Terms” shall mean the Special Terms, if any, attached to the Order as Appendix B.

Any different or additional terms in any order (that is not the Order), proposal, offer, or other writing from Customer to Trailhead shall be deemed a material alteration of these Standard Terms and are hereby expressly objected to and rejected and shall be of no force or effect. Trailhead’s failure to object to any such terms and conditions from Customer will neither be construed as Trailhead’s acceptance of such terms and conditions nor a waiver of these Standard Terms or the terms and conditions set forth in the Order. Commencement of performance shall not be construed as acceptance of any of Customer’s terms and conditions which are different from or in addition to those contained in these Standard Terms or the terms and conditions set forth in the Order. Course of performance or usage of trade shall not be applied to modify these Standard Terms or the terms and conditions of any Order. Trailhead’s offer to provide the Trailhead Materials is expressly conditioned upon Customer’s acceptance of these Standard Terms.

Customer and Trailhead may be referred to collectively as the “Parties” and individually as a “Party” in the Agreement. The capitalized terms defined above and defined elsewhere in the Agreement, whether used in the singular or the plural, shall have the meaning assigned to such capitalized terms in the Agreement.

 

1          Trailhead Materials

1.1        “Trailhead Materials” means any biological cells, culture media, media formulations, components of media, supplements to media, substrates, and any other chemical, biological or other tangible compounds, materials, kits, and products that that Customer orders as set forth in the Order and that Trailhead delivers to Customer or any Authorized Contractor (as defined below) of Customer, including without limitation any biological cells originally delivered by Trailhead and further differentiated by or on behalf of Customer or any Authorized Contractor from use of culture media or supplements to media or other non-cell materials delivered by Trailhead.

 

2          Delivery; Acceptance; Payment

2.1        Trailhead will supply the Trailhead Materials specified in the Order within Trailhead’s standard delivery times for such Trailhead Materials as may be stated in the Order for such Trailhead Materials and in the quantities specified by Customer in the Order. Trailhead will ship and deliver the Trailhead Materials ordered by Customer to the delivery address specified by Customer in the Order. Trailhead will select the carrier for transportation of the Trailhead Materials ordered. Trailhead will, prior to delivery, package the Trailhead Materials ordered by Customer for transportation in conformity with Trailhead’s standard packaging specifications.

2.2        Customer shall pay the use fee for the Trailhead Materials ordered and not rejected by Customer pursuant to Section 2.3 hereof, which use fee shall be as specified in the Order for type and the quantity of Trailhead Materials ordered by Customer in good and immediately available funds. Payment of the use fee for the Trailhead Materials ordered shall be due within thirty (30) days from receipt of Trailhead’s invoice for such Order, which Trailhead will deliver to Customer via electronic mail to Customer’s email address specified on the Order, unless the Parties mutually agree in writing on different payment terms. Trailhead will deliver its invoice following shipment of the Trailhead Materials ordered by Customer. Customer shall pay all applicable federal, state, and local sales, excise, and other taxes, fees, assessments, customs duties, tariffs, or similar governmental impositions imposed by any governmental body or any subdivision thereof or any customs service with respect to the order, shipment, import, export, and/or storage of Trailhead Materials by Customer (except for income taxes imposed on the income of Trailhead derived from the orders of Trailhead Materials by Customer). Customer shall pay all invoiced charges for shipping and handling of the Trailhead Materials ordered by Customer. Payment shall be made by check made payable to the order of Trailhead Biosystems Inc. or by bank wire transfer or via ACH (Automated Clearing House) transfers into a bank account of Trailhead as specified by Trailhead. Customer represents and warrants that the amounts paid pursuant to the Order (i) reflect the fair market value of the materials being provided, (ii) have been negotiated in an arm’s-length transaction, and (iii) have not been determined in any manner with regard to any implicit or explicit agreement to provide favorable procurement decisions with regard to Customer’s or its affiliate’s or collaborator’s products, or to the value or volume of any business or referrals generated between the parties or such affiliates or collaborators.

2.3        Delivery of Trailhead Materials ordered by Customer will occur in accordance with Section 2.2 hereof, provided however that Customer shall have the right to inspect the Trailhead Materials so delivered upon arrival at Customer’s facilities for conformity with the specifications in the Order for such Trailhead Materials for a period of thirty (30) business days from the date of arrival, or such longer period, if any, as specified in the Order or the Special Terms, and prior to any use by Customer of such Trailhead Materials in any research activity (the “Rejection Period”). All deliveries of Trailhead Materials shall be deemed accepted by Customer, unless Customer notifies Trailhead prior to expiration of the Rejection Period of any such non-conformity with reasonable specificity. Trailhead shall bear the cost of return shipments of non-conforming materials delivered, provided that Trailhead has elected the return of non-conforming materials; otherwise, Customer shall promptly destroy the rejected Trailhead Materials as instructed by Trailhead and confirm such destruction to Trailhead. Customer may not reject any Trailhead Materials for non- conformity if such non-conformity was caused by their storage, use, or transportation following delivery thereof by Trailhead in accordance with Section 2.1 hereof. Trailhead, at its option, will either refund Customer’s payment, if any, already made to Trailhead pursuant to Section 2.2 hereof for the Trailhead Materials that were timely and properly rejected by Customer pursuant to this Section 2.3, or will deliver Trailhead Materials that conform to the specifications in the Order for such Trailhead Materials within thirty (30) days' notice of rejection.

 

3          Trailhead Materials and Their Use

3.1        Customer shall use, and shall cause and permit the use of, the Trailhead Materials solely in Customer’s internal research in connection with the development of pharmaceutical, biologics, or regenerative medicine products, treatments, applications, and/or services provided that notwithstanding the foregoing, Customer shall not use, and shall not cause and permit the use of, any Trailhead Materials in any Excluded Research (as defined below), unless and only to the extent specifically permitted in the Order or any Special Terms, (the “Permitted Purpose”).

3.1.1      As used herein “Excluded Research” means (i) research or development of any therapeutic, treatment, cure, repair, improvement, or palliation of any disease, injury, damage, or condition in humans or animals that utilizes any Trailhead Materials or any biological cell generated, differentiated, modified, or improved from use of any Trailhead Materials or any type of biological cell of the same or similar type as the Trailhead Materials or as any biological cell generated, differentiated, modified, or improved from use of any Trailhead Materials, and (ii) any use of the Trailhead Materials otherwise prohibited by the terms of the Agreement.

3.1.2         For clarity, the Permitted Purpose shall include the use of Trailhead Material ordered by Customer that is in the form of cell culture media in order to differentiate stem cells or progenitor cells into specialized biological cells for use in Customer’s internal research associated with the development of pharmaceutical, biologics, or regenerative medicine products, treatments, applications, and/or services, other than in Excluded Research, provided that (i) any such use is in compliance with the Order and any Special Terms and the protocol(s) and instructions provided by Trailhead with respect to such Trailhead Materials, and (ii) such use is otherwise in compliance with the Agreement.

3.2        Customer acknowledges and agrees, and shall cause any Authorized Contractor (as defined below), to acknowledge and agree that Trailhead owns and shall own and shall hold and retain all ownership rights in the Trailhead Materials and shall hold and retain all right, title, and interest in and to the Trailhead Materials and shall continue to hold and retain all right, title, and interest in and to the Trailhead Materials upon the transfer of any such Trailhead Materials to Customer (or to any Authorized Contractor) or upon their creation. Customer agrees to treat, and shall cause any Authorized Contractor to treat, all of the Trailhead Materials as the sole and exclusive property of Trailhead. Customer agrees, and shall cause any Authorized Contractor to agree, that Trailhead owns and retains all ownership in any and all protocols and instructions and data, including any RNA sequencing data or analyses thereof, provided or made available by Trailhead with Trailhead Materials, including prior to or following delivery to Customer (or any Authorized Contractor) of Trailhead Materials, (collectively, “Protocols”). Customer shall not, and shall cause any Authorized Contractor not to, imply or represent to any Person (as defined below) that Customer or any Authorized Contractor is the owner of any Trailhead Materials or the Protocols. The provisions of this Section 3.2 shall also apply to any Trailhead Materials made or created in violation of this Agreement.

3.3             Customer agrees to use and cause and permit the use of the Trailhead Materials solely for the Permitted Purpose and not for any other purpose. Customer may only use or cause or permit the use of the Trailhead Materials (i) in Customer’s laboratories or research facilities on its premises except as provided in Section 3.6 below; (ii) in accordance with the applicable specifications of the Order and any Special Terms and the Protocols and Trailhead’s instructions concerning the storage, handling, use, return, and disposal of the Trailhead Materials; and (iii) in all respects in accordance with the terms and conditions of the Agreement. Customer will not use or cause or permit the use of any Trailhead Materials other than as expressly permitted under the Agreement. Customer agrees to use and cause and permit the use of the Protocols solely for the Permitted Purpose and not for any other purpose.

3.4        Customer agrees not to, and shall not cause or permit any other person or entity (“Person”) to, reverse engineer any of the Trailhead Materials or analyze or deduce or discover or determine the identity, composition, components, ingredients, structure, or method of manufacture, of any of the Trailhead Materials, or otherwise derive proprietary information from any of the Trailhead Materials, in any manner or attempt to any of the following, provided that solely in furtherance of the Permitted Purpose, Customer may analyze the Trailhead Materials that are biological cells and any biological cells created from use of the Trailhead Materials and such use is in compliance with the applicable Protocols and the Order and any Special Terms and in compliance with the Agreement. For clarity and without limiting the generality of the foregoing, Customer shall not, and shall not permit any other Person to, analyze or deduce or determine the composition or components of any culture media, supplements to media, or any other non-cell materials that constitute or that are part of the Trailhead Materials.

3.5        Customer shall not, and shall not permit any other Person to, use any Trailhead Materials or any Protocols to create or make or facilitate the creation of any progeny, copies, reproductions, derivatives, modifications, or improvements (whether in terms of composition, function, performance, transplantation, tolerance, or otherwise) of any Trailhead Materials or to develop any protocol or method for the making of any Trailhead Materials. Except as specifically authorized in the Order or any Special Terms, Customer shall not, and shall not permit any other Person to, culture or expand or grow any biological cells that are part of the Trailhead Materials. Except as specifically authorized in the Order or any Special Terms, Customer shall not, and shall not permit any other Person to, differentiate any biological cells that are part of the Trailhead Materials. Notwithstanding the foregoing provisions of this Section 3.5, to the extent the Order provides for cell culture media to be delivered to Customer by Trailhead as part of the Trailhead Materials, Customer may use such Trailhead Materials that are culture media as so specified in the Order or any Special Terms to differentiate or treat the Trailhead Materials that are biological cell(s) or other biological cells not provided by Trailhead as specified in such Order or any Special Terms solely for the Permitted Purpose.

3.6        Customer shall maintain the Trailhead Materials in its possession and, subject to the provisions of this Section 3.6, shall not make available, disclose, transfer, sell, or distribute any Trailhead Materials to any affiliate or any other third party without the prior written consent of Trailhead, provided that during the Term (as defined below) hereof, Customer may make available the specified Trailhead Materials to such contractor of Customer, if any, specifically identified in the Order or any Special Terms (“Authorized Contractor”) solely for use by such Authorized Contractor as specified in the Order or any Special Terms in furtherance of the Permitted Purpose and otherwise subject to the terms and conditions of this Agreement. Customer shall ensure that such Authorized Contractor shall use the Trailhead Materials only in such Authorized Contractor’s laboratories or research facilities on its premises. Customer shall inform such Authorized Contractor of the ownership, access, use, transfer, and disclosure restrictions and provisions of the Agreement with respect to the Trailhead Materials and shall enter into a legally binding contract with such Authorized Contractor which shall require such Authorized Contractor to comply with these restrictions and provisions, and shall provide such agreement to Trailhead within fifteen (15) days of its execution by Customer and Authorized Contractor. Customer shall cause such Authorized Contractor to comply with the terms and conditions of the Agreement that are applicable to Customer and Authorized Contractor, and which Trailhead has the authority to enforce, and any non-compliance by such Authorized Contractor, or any of its directors, officers, employees, or representatives, with the terms and conditions of the Agreement applicable to Customer or to such Authorized Contractor shall be deemed a violation and breach of the Agreement by Customer. Customer acknowledges and agrees that any such Authorized Contractor will act on behalf of Customer for purposes of the Agreement.

3.7             Customer shall restrict access to and use of the Trailhead Materials to its employees and those of its Authorized Contractor, if any, that: (i) are directly engaged in performing tasks in furtherance of the Permitted Purpose; (ii) need to access and use the Trailhead Materials for the Permitted Purpose; and (iii) have been informed of the access, use, transfer, and disclosure restrictions of this Agreement and are subject to a legally binding obligation to comply with these restrictions.

3.8             Customer shall, and shall cause any Authorized Contractor to, maintain commercially reasonable security designed to prevent theft or loss of the Trailhead Material. Customer shall, and shall cause any Authorized Contractor to, use the Trailhead Materials in a safe manner and in compliance with all applicable federal, state, and local laws and regulations. Customer will, and will cause any Authorized Contractor to, take commercially reasonable steps to ensure that all persons involved in receiving, handling storing, using, or disposing of the Trailhead Materials are adequately qualified by training and experience to do so safely.

3.9        Customer acknowledges and agrees that Trailhead shall have no obligation to disclose the composition or components of any Trailhead Materials or any data related to any use or testing of any Trailhead Materials.

3.10          Trailhead Materials shall not be used by or on behalf of Customer for treatment of humans or animals nor used in or for anything destined for human or animal consumption. Customer shall ensure that the Trailhead Materials will not be used by or on behalf of Customer for testing in humans. Subject to the other terms of the Agreement, Customer may use or cause or permit the use of the Trailhead Materials for testing in non-human animals consistent with the Permitted Purpose, provided that any such testing is conducted in compliance with all applicable federal, state, and foreign laws and regulations and requirements and all applicable internal rules and regulations and requirements of Customer and any Authorized Contractor, if any, and has been approved by all applicable government and regulatory agencies and by all internal review boards or other internal bodies of Customer or its Authorized Contractor required to approve any such testing. Customer shall indemnify, defend, and hold harmless Trailhead and its affiliates, and its and their respective officers, directors, employees, agents, stockholders, successors, and assigns, from and against any claims, judgments, damages, liabilities, settlements, losses, costs, and expenses, including attorneys' fees and disbursements, arising from or relating to (i) any use or testing of any Trailhead Materials in non-human animals or (ii) any breach or non-compliance by Customer or any of its contractors of the foregoing provisions of this Section 3.10.

3.11          Customer shall not use, and shall not permit any other Person to use, Trailhead Materials, in whole or in part, to develop or make any type of biological cell for which Customer or such other Person claims or seeks any patent protection, including any composition of matter claim or any method or manufacture claim under any such patent or patent application.

3.12          Customer shall not use, and shall not permit any other Person to use, Trailhead Materials, in whole or in part, in the development of any therapeutic, treatment, cure, repair, improvement, or palliation of any disease, injury, damage, or condition in humans or animals that utilizes any Trailhead Materials. Any such use shall require the prior written consent of Trailhead and shall be subject to additional terms and conditions as will be provided by Trailhead.

3.13          Customer shall not use, or cause or permit the use of, Trailhead Materials, in whole or in part, for the purpose of applying for or obtaining any patent on or claiming  any use of any Trailhead Materials or on any composition of matter involving any Trailhead Materials or on any method of manufacture of any Trailhead Materials or on any derivative or any modification thereof or improvement thereto made from the use of any Trailhead Materials.

3.14       Customer shall not use, or cause or permit the use of, the Trailhead Material: (i) in any manner that confers on Customer or any third party any Intellectual Property Rights (as defined below) in or to the Trailhead Material or any portion thereof; or (ii) for any commercial purpose, including the sale of any Trailhead Material or any incorporation of Trailhead Material into products intended for commercial sale.

3.15       Customer shall not, and shall cause any Authorized Contractor not to, remove the Trailhead logo or any proprietary rights, markings, or legends indicating that the Trailhead Materials are owned by Trailhead which appear on or were provided with the packaging or any container(s) holding any Trailhead Materials. Customer shall and shall cause any Authorized Contractor to store and transport Trailhead Materials only in containers bearing the Trailhead logo and any such proprietary rights, markings, and legends that appear on or were provided with the original container(s) holding the Trailhead Materials.

3.16       Customer shall be responsible for the compliance by its directors, officers, employees, consultants, advisors, contractors, or representatives with the terms of this Agreement, and any disclosure or use of Trailhead Materials that is inconsistent with the terms of this Agreement by any of Customer’s directors, officers, employees, consultants, advisors, contractors, or representatives shall be deemed a violation and breach of this Agreement by Customer.

3.17       Customer and Authorized Contractor shall comply with the provisions set forth in Annex 1 hereto, provided that to the extent the terms of the Agreement impose greater restrictions or limitations on Customer, whether concerning use of Trailhead Materials, any transfer of Trailhead Materials, or otherwise, than the provisions set forth in Annex 1 impose, such other term(s) shall govern.

 

4          Intellectual Property

4.1        “Intellectual Property Rights” means any and all registered and unregistered rights granted, applied for or otherwise now or hereafter in existence under or related to any utility and design patent, copyright, trademark, trade secret, database right, database protection or any other intellectual property rights under any intellectual property laws, and all similar or equivalent rights or forms of protection, in any part of the world, including the right to apply for and to receive patents of the United States and countries foreign thereto and the right to claim for any of said applications the full benefits and priority rights under the International Patent Cooperation Treaty, as amended, the Paris Convention for the Protection of Industrial Property, as amended, and any and all other international agreement, treaty or convention to which the United States adheres.

4.2             Trailhead does not grant to Customer any express or implied license or other rights under any Intellectual Property Rights other than Trailhead’s consent to the non-exclusive use of the Trailhead Material and any Protocols by Customer and any Authorized Contractor solely for the Permitted Purpose and subject to the other terms and conditions of the Agreement during the Term or earlier termination of the Agreement and, in any event, until Customer is obligated to return or otherwise dispose of the Trailhead Materials as instructed by Trailhead. Nothing in the Agreement will be construed as granting to Customer or any other Person any Intellectual Property Rights to, or ownership rights in or to, any of the Trailhead Material or any Protocols, including in or to any trade secret or in or to any invention, copyright, patent application or patent.

4.3        Without limiting the remedies that may be available to Trailhead at law, in equity or otherwise, Customer hereby assigns and transfers to Trailhead, and shall cause the assignment and transfer to Trailhead by any Authorized Contractor or any of Customer’s or such Authorized Contractor’s employees or consultants, of any and all Intellectual Property Rights to, and title, ownership, and all rights, title and interest in and to, any of the following that are created, developed, or made in violation of the Agreement: (1) any and all progeny, copy, reproduction, derivative, modification, or improvement (whether in terms of composition, function, performance, transplantation, tolerance, or otherwise) of any Trailhead Materials, and (2) any and all biological cell generated or made or differentiated or modified or improved from use of any Trailhead Materials or any materials under clause (1) and (3) any method for making any materials under clause (1) or clause (2).

4.4         Without limiting the remedies that may be available to Trailhead at law, in equity or otherwise, each of Customer and any Authorized Contractor hereby assigns and transfers to Trailhead, and shall cause the assignment and transfer to Trailhead of, any and all Intellectual Property Rights and all rights, title and interest in and to all inventions created or made in violation of Sections 3.4, 3.5, 3.11, 3.12, 3.13, or 3.14(i), whether or not patentable, and to all patents and patent applications claiming any such invention and all related priority rights and any and all other related Intellectual Property Rights.

4.5        Without limiting the remedies that may be available to Trailhead at law, in equity, or under the Agreement, to the extent that, notwithstanding the provisions of Section 4.3 or Section 4.4, Customer for any reason retains any right, title, or interest in and to the inventions and Intellectual Property Rights assigned or transferred to Trailhead pursuant to Section 4.3 or Section 4.4, each of Customer and any Authorized Contractor hereby (i) grants, and shall cause to be granted, to Trailhead a perpetual, irrevocable, fully paid-up, royalty-free, freely transferrable, sublicensable (with a right to sublicense through multiple levels of sublicensees), exclusive (including exclusive as to Customer and Authorized Contractor), worldwide right and license under any and all patent rights and any and all other Intellectual Property Rights, to practice and otherwise exploit, including through use, sale, offer for sale, making, importing, modifying, and improving (whether in terms of composition, function, performance, transplantation, tolerance, or otherwise), any and all inventions, whether or not patentable, made in material violation of Sections 3.4, 3.5, 3.11, 3.12, 3.13, or 3.14(i) hereof (“Licensed Inventions”), (ii) agrees, at Trailhead’s request and expense, to consent to and join in any action to enforce such rights granted under this Section 4.5 and (iii) agrees to first notify Trailhead and, upon, request by Trailhead, assign and transfer each patent and patent application claiming a Licensed Invention, and all related priority rights, to Trailhead in consideration for payment of $1.00 before abandoning any patent or patent application that claims a Licensed Invention in whole or in part.  Customer shall, and shall cause any Authorized Contractor to, promptly notify Trailhead of any Licensed Invention and shall not disclose any Licensed Invention to any other person or entity except as required in connection with patent prosecution of the Licensed Invention.

4.7        Each of Contractor and Authorized Contractor shall secure sufficient rights from their respective employees and contractors to effect the grant of rights set forth in this Section 4 to Trailhead.

4.8         Trailhead agrees and acknowledges that Customer is not required to disclose or report to Trailhead or share with Trailhead any data, analyses, or other results generated or derived from use of the Trailhead Materials by Customer in compliance with the Agreement (“Results”). In the event Customer publishes the Results, in accordance with scientific custom, the contribution of Trailhead in supplying the Trailhead Materials will be expressly noted in all written or oral public disclosures, as appropriate.

 

5          Disclaimer of Warranties; Limitation of Liability

5.1        CUSTOMER ACKNOWLEDGES AND AGREES THAT THE TRAILHEAD MATERIALS ARE EXPERIMENTAL IN NATURE AND MAY HAVE UNKNOWN CHARACTERISTICS, OR BE OTHERWISE HAZARDOUS AND, THEREFORE, SUPPLIED TO CUSTOMER “AS IS” AND THAT THE TRAILHEAD MATERIALS AND THE PROTOCOLS ARE PROVIDED OR MADE AVAILABLE WITHOUT ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED. TO THE FULLEST EXTENT PERMITTED BY LAW, TRAILHEAD HEREBY DISCLAIMS ALL WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY, AND SPECIFICALLY DISCLAIMS 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. WITHOUT LIMITING THE FOREGOING, TRAILHEAD MAKES NO WARRANTY OF ANY KIND THAT THE TRAILHEAD MATERIALS WILL MEET CUSTOMER’S OR ANY OTHER PERSON'S REQUIREMENTS, PERFORM IN ACCORDANCE WITH THE PROTOCOLS PROVIDED, ACHIEVE ANY INTENDED RESULT, OR BE ERROR–FREE, ACCURATE, OR EXHIBIT THE DESIRED FUNCTIONALITIES OR FEATURES OR QUALITY. WITHOUT LIMITING THE FOREGOING, TRAILHEAD MAKES NO WARRANTY OF ANY KIND THAT USE OF THE PROTOCOLS WILL ACHIEVE ANY INTENDED RESULT, OR THAT PROTOCOLS BE ERROR–FREE, ACCURATE, OR COMPLETE.

5.2        NEITHER TRAILHEAD NOR ANY OF ITS 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 THE AGREEMENT OR THE SUBJECT MATTER OF THE AGREEMENT OR OTHERWISE. THE EXCLUSIONS OF A PERSON’S LIABILITY SET FORTH IN THIS SECTION 5.2 ABOVE APPLY REGARDLESS OF WHETHER SUCH 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.

5.3        WITHOUT LIMITING THE GENERALITY OF SECTION 5.2, TRAILHEAD SHALL NOT BE LIABLE FOR ANY LOSS, CLAIM, DAMAGE, OR LIABILITY OF ANY KIND OR NATURE WHICH MAY ARISE FROM OR IN CONNECTION WITH THE USE, HANDLING, OR STORAGE OF THE TRAILHEAD MATERIALS, EXCEPT TO THE EXTENT THAT SUCH LOSS, CLAIM, DAMAGE OR LIABILITY ARISES FROM THE GROSS NEGLIGENCE OR WILLFUL MISCONDUCT OF TRAILHEAD. THIS SECTION 5.3 SHALL NOT NEGATE TRAILHEAD’S OBLIGATIONS TO REFUND OR SEND REPLACEMENT FOR NON-CONFORMING PRODUCES PROVIDED IN AND SUBJECT TO THE PROVISIONS OF SECTION 2.3.

5.4             TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL THE AGGREGATE LIABILITY OF TRAILHEAD, ITS AFFILIATES, STOCKHOLDERS, OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, AND SUPPLIERS ARISING OUT OF OR RELATED TO THE AGREEMENT, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE), STATUTE, OR OTHERWISE, TO CUSTOMER OR ANY USER OR ANY OTHER PERSON EXCEED THE TOTAL OF THE AMOUNTS PAID TO TRAILHEAD UNDER THE AGREEMENT. THE FOREGOING LIMITATIONS APPLY EVEN IF THE CUSTOMER’S REMEDIES UNDER THE AGREEMENT FAIL OF THEIR ESSENTIAL PURPOSE.

5.5        The Parties acknowledge that the foregoing limitations and exclusions set forth in this Section 5 shall bind any Authorized Contractor.

 

6          Term and Termination

6.1             The Agreement shall terminate upon the expiration of the Term specified in the Order, unless terminated earlier pursuant to this Section 6.

6.2        Notwithstanding the foregoing, either Party may terminate the Agreement if the other Party materially breaches the Agreement, and such breach: (i) is incapable of cure; or (ii) being capable of cure, remains uncured thirty (30) days after the non-breaching party provides the breaching Party with written notice of such breach.

6.3        Upon termination or expiration of the Agreement, Customer’s rights to use the Trailhead Materials and the Protocols shall end, and Customer shall cease, and shall cause the cessation by or on behalf of Customer and by any Authorized Contractor of, all uses of the Trailhead Materials and the Protocols and, at Trailhead’s option and direction and Trailhead’s cost and expense, shall, within thirty (30) days, return to Trailhead or, at Trailhead’s instruction (which may be delivered by electronic mail) destroy and cause the destruction of all remaining Trailhead Materials and all Protocols in the possession or under the control of Customer or any Authorized Contractor of Customer, with notification confirming such destruction sent by Customer to Trailhead via email at info@trailbio.com and legal@trailbio.com. Following the expiration or earlier termination of the Agreement, the Parties shall have no further obligations under the Agreement, except that Sections 1.1, 3, 4, 5, 6.3, and 7 shall survive any such expiration or earlier termination.

 

7          Miscellaneous

7.1             Injunctive Relief. Customer acknowledges that a material breach or threatened breach of the Agreement by Customer may cause irreparable harm and significant injury to Trailhead for which damages at law may not be an adequate remedy, and Customer agrees that Trailhead shall have, in addition to any other rights or remedies available to it at law or in equity, the right to seek injunctive relief to enjoin any breach or violation or specific performance of the provisions of the Agreement 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. Such remedies are not exclusive and are in addition to all other remedies that may be available at law, in equity or otherwise. Customer shall ensure that any Authorized Contractor shall be bound by this Section.

7.2        Entire Agreement; Modifications. The Order and the Standard Terms and the Special Terms, if any, contain the entire agreement and understanding of the Parties with respect to the subject matter hereof (“Agreement”) and shall supersede and merge all prior and contemporaneous communications, agreements, understandings, undertakings and obligations with respect to the subject matter hereof, whether oral or written, unless the Parties have entered into a separate definitive written agreement with respect to the subject matter hereof which has been signed by the authorized representative(s) of each Party. No modification or amendment of the Agreement, including the Order or the Standard Terms or the Special Terms, shall be binding on either Party unless set forth in writing and signed by both Parties. No quote, order other than the Order, or similar document shall modify the terms of the Agreement even if accepted by the receiving Party. Notwithstanding the foregoing, the Agreement does not supersede any Non-Disclosure Agreement or Confidentiality Agreement, if any, entered into by the Parties, which shall continue to be in full force and effect.

7.3             Marketing.  From time-to-time, Trailhead lists and/or mentions its customers in its marketing and communications initiatives.  Customer hereby grants Trailhead the right during the Term of this Agreement to identify Customer as a user of Trailhead’s products by name and logo in Trailhead’s sale and marketing collateral and on its website.

7.4             Independent Contractor. In connection with the Agreement, each Party is an independent contractor. The Agreement shall not create any relationship of employment, agency, joint venture, or partnership between the Parties and shall not give either party any authority to bind or commit any other Party. Trailhead shall not owe any fiduciary duty to Customer.

7.5             No Further Obligation. Nothing in the Agreement shall be deemed to create any obligation on the part of either Party to enter into a further agreement.

7.6             Assignment. Customer shall not assign the Agreement or any rights or obligations hereunder without the prior written consent of Trailhead; provided, however, that no consent shall be required for any assignment by Customer in connection with the sale or transfer of all or substantially all of the business of Customer to which the Agreement relates. Any such purported or attempted assignment, transfer, or delegation in violation of this Section 7.6 shall be void and without force and effect. Subject to the foregoing, the Agreement shall be binding upon and inure to the benefit of the Parties hereto and their respective successors and assigns. The Parties agree that the Agreement is by and between Trailhead and Customer, and that there shall be no intended third-party beneficiaries to the Agreement.

7.7             Severability. Every provision of the Agreement is intended to be severable. If any term or provision hereof is unenforceable, illegal, or invalid for any reason whatsoever by a court of competent jurisdiction, then (a) such illegality or invalidity shall not affect the validity or legality of the remainder of the Agreement, which shall remain in full force and effect, and (b) the Parties agree to negotiate in good faith to draft a new legal and enforceable provision that to the maximum extent possible under applicable law comports with the original intent of the Parties and maintains the economic and other terms to which the Parties originally agreed.

7.8             Notices. Any notices required or permitted hereunder will be given to the applicable Party in writing to the mailing address specified in the Order by certified mail or by electronic mail at the applicable email address as specified in the Order, or at such other mailing address or email address as may be notified to the other Party in accordance with this Section 7.8.

7.9             Waiver. No waiver of any term or condition of the Agreement shall be valid or binding on a Party unless the same shall have been in writing and signed by an officer of such Party. The failure of a Party to enforce at any time any of the provisions of the Agreement, or the failure to require at any time performance by the other Party of any of the provisions of the Agreement, shall in no way be construed to be a present or future waiver of such provisions, nor in any way adversely affect the right of a Party to enforce each and every provision thereafter.

7.10       Applicable Law; Exclusive Choice of Forum. The Agreement shall be governed by, and construed and enforced in accordance with, the internal laws of the State of Delaware (United States of America), without giving effect to any choice or conflict of law provisions or rule that would require or permit application of the laws of any jurisdiction. Any legal suit, action, or proceeding arising out of or related to the Agreement will be brought and instituted exclusively in the U.S. District Court for the District of Delaware (to the extent such court has independent subject matter jurisdiction) or the courts of the State of Delaware in each case located in the State of Delaware (United States of America), and each Party hereby irrevocably submits to the exclusive jurisdiction of such courts in any such suit, action, or proceeding. Notwithstanding the foregoing, a Party may pursue an action before any other court to obtain recognition of and to enforce any judgment or court order or to seek injunctive relief pursuant to Section 7.9 hereof. Customer shall ensure that any Authorized Contractor shall be bound by this Section 7.10 hereof.

7.11          Waiver of Trial by Jury. EACH PARTY TO THE AGREEMENT HEREBY IRREVOCABLY WAIVES ANY AND ALL RIGHTS SUCH PARTY MAY HAVE, NOW OR IN THE FUTURE, TO HAVE ANY CONTROVERSY OR CLAIM BETWEEN THEM, ARISING OUT OF OR RELATING TO THE AGREEMENT OR ANY TRANSACTION CONTEMPLATED BY THE AGREEMENT 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. Customer shall ensure that any Authorized Contractor shall also be bound by this Section 7.11 and shall be bound by a corresponding waiver.

7.12          Responsibility. Each Party shall be responsible for the compliance by its employees, directors, officers, agents, representatives, consultants, advisors, and contractors with its obligations under the Agreement, and any non-compliance by any of the employees, directors, officers, agents, representatives, consultants, advisors, or contractors of a Party with the terms of or obligations under the Agreement applicable to such Party will be deemed a breach of the Agreement by such Party.

7.13          Interpretation. The section and other headings contained in the Agreement are for convenience or reference purposes only and are not intended to describe, interpret, define, or limit the scope, extent, or intent of the Agreement or any provision hereof. All references to days or months shall be deemed references to calendar days or months. All references to “$” shall be deemed references to United States dollars. Unless the context otherwise requires, any reference to a “Section” or “Schedule” shall be deemed to refer to a section of the Agreement or Schedule to the Agreement, as applicable. The words “hereof,” “herein” and “hereunder” and words of similar import referring to the Agreement refer to the Agreement as a whole and not to any particular provision of the Agreement. Whenever the words “include”, “includes” or “including” are used in the Agreement, they will be deemed to be followed by the words “without limitation.” Whenever required by the context, and as used in the Agreement, the singular number shall include the plural, and pronouns and any variations thereof shall be deemed to refer to the masculine, feminine, neuter, singular or plural, as the identity of the person or persons may require. The provisions of the Agreement shall be construed according to their fair meaning and neither for nor against any Party hereto irrespective of which Party caused such provisions to be drafted.

7.14       Changes to Standard Terms. Trailhead reserves the right to change these Standard Terms at any time. Any changes made to these Standard Terms will not apply to the Agreement between Trailhead and Customer entered into by Trailhead and Customer before the changes are made.

 

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