TERMS AND CONDITIONS
These Ossium Health Terms and Conditions, as amended from time to time (the “Terms and Conditions”), are entered into by and between Ossium Health, Inc., a Delaware corporation (“Ossium”), and the customer identified in an order form for Ossium products (each such order form, an “Order Form”, and such customer, the “Customer”) that references these Terms and Conditions. “Party” will mean Customer or Ossium, individually. “Parties” will mean both Customer and Ossium. These Terms and Conditions and each Order Form make up the entire agreement between the Parties (collectively, the “Agreement”). The Agreement will be effective as of the effective date set forth in a confirmation email from Ossium (the “Effective Date”).
NOW THEREFORE, in consideration of the mutual covenants and agreements set forth in the Agreement, Ossium and Customer hereby agree as follows:
1.1 “Act” will mean the Federal Food, Drug and Cosmetic Act, as amended to date and during the Term, including, without limitation, any and all implementing regulations.
1.2 “Affiliate” of a Party to this Agreement will mean any corporation, partnership or other entity which, directly or indirectly, Controls, is Controlled by, or is under common Control with such Party; provided that such entity will be considered an Affiliate only for the time during which such Control exists.“Confidential Information” will mean, unless agreed in writing to the contrary, any tangible or intangible information or material regarding the business, markets, technologies, products, or proprietary processes of Ossium or Customer, as the case may be, including, without limitation, Intellectual Property, research, development, customer lists and marketing information; provided, however, that “Confidential Information” will not include information that (a) can be demonstrated to have been in the public domain or publicly known prior to the date of disclosure by the disclosing Party; (b) that can be demonstrated from written records to have been in the receiving Party’s possession from another source not under an obligation of secrecy to the disclosing Party prior to disclosure by the disclosing Party; (c) that becomes part of the public domain or publicly known, by publication or otherwise, not due to any unauthorized act by the receiving Party; or (d) is independently developed by the receiving Party without use of or reference to the Confidential Information of the disclosing Party and without breach of this Agreement, as evidenced and verified by prior tangible evidence. Without limiting the generality of the foregoing, Ossium’s Confidential Information includes, without limitation, pricing terms; complaint, recall, and Product defect information; non-public Product Feedback; bone marrow donor information; and any and all terms of this Agreement.“Control” will mean the ownership or control, directly or indirectly, of more than 50% of all of the voting power of the shares (or other securities or rights) entitled to vote for the election of directors or other governing authority, as of the date of this Agreement or hereafter during the Term, but only while and for so long as such ownership or control exists.“Data” will mean any and all proprietary data that Ossium discloses to Customer.
1.3 “FDA” will mean the United States Food and Drug Administration, or any successor agency.
1.4 “Governmental Authority” will mean any of the countries or geographic areas where the Products are distributed in accordance with this Agreement, including, without limitation, the United States of America, and applicable states, counties, municipalities, any political subdivision thereof, and any agency, department, commission, board, bureau or instrumentality of any of the foregoing, including, without limitation, the FDA, now existing or hereafter created, having jurisdiction over this Agreement and the subject matter hereof.
1.5 “Intellectual Property” of Ossium or Customer, as the case may be, will mean any and all Know-How, patents and patent applications, trademarks and trademark applications, trade secrets, and copyrights, presently or hereafter owned by such Party and/or in which such Party has or obtains any right, title or interest and, insofar as such Party has any right to grant sublicenses thereunder, any patents, patent applications, trademarks or trademark applications relating to the foregoing as to which such Party has or obtains any license, and any continuations, continuations-in-part, divisions, reissues and reexaminations, and all foreign equivalents, of any or all of the foregoing.
1.6 “Know-How” will mean any and all of a Party’s trade secrets, specifications, test results, analyses, data, inventions, methods, processes, formulae, compositions, designs, techniques, applications, ideas or concepts, whether or not reduced to practice, including, without limitation, technology that is or could be the subject matter of a foreign or domestic patent or patent application, whether or not reduced to writing in a patent application.
1.7 “Laws” will mean all present and future laws, including, without limitation, the Act, rules, orders, ordinances, regulations, statutes, requirements, codes, executive orders, rules of common law, and any judicial interpretations thereof of all Governmental Authorities, and all rules, regulations and government orders with respect thereto, in each case solely to the extent any such laws apply to either Party’s conduct or obligations under this Agreement.
1.8 “Products” will mean those whole bone marrow and bone marrow-derived products from cells acquired from bone marrow from human organ and/or tissue donors and processed in accordance with the Technical Guidelines for use in research and other pre-clinical research use cases within the United States and such other products or materials that Ossium agrees to provide to its customers.
1.9 “Technical Guidelines” will mean the technical standards, guidelines, or supporting material of Products, prepared by Ossium and as amended from time to time.
PRODUCTS AND ORDERS
2.1 Purchase and Sale. Subject to the terms and conditions of this Agreement, Customer will purchase from Ossium, and Ossium will sell, Products to Customer, as provided herein. The Terms and Conditions will apply to any current and future Products and sale and provision of Products by Ossium to Customer, unless the Parties have expressly agreed otherwise in writing with regard to any or all topics addressed herein, as the case may be. By submitting an Order Form to Ossium to place an order, or by checking a box or clicking a button marked “Submit”, or something similar, Customer hereby accepts these Terms and Conditions to their fullest extent. Customer may place a binding order for a quantity of Products by confirming Customer’s order and shipment information and paying all listed fees on an Order Form. Ossium may reject or cancel an Order Form, at any time and in its sole discretion (in whole or in part), without liability or penalty, and without constituting a waiver of any of Ossium’s rights or remedies under this Agreement or any Order Form, by providing written notice to Customer specifying the applicable date of rejection or cancellation. If Ossium accepts an Order Form and subsequently cancels such Order Form for convenience, Ossium will refund sums paid by Customer pursuant to such Order Form.
2.2 Order of Precedence. The Parties intend for the express terms and conditions contained in this Agreement to exclusively govern and control each of the Parties’ respective rights and obligations regarding the subject matter of this Agreement, and this Agreement is expressly limited to such terms and conditions. Without limitation of the foregoing, any additional, contrary or different terms contained in any Order Form, other agreement, or other request or communication by Customer pertaining to the sale of Products by Ossium, and any attempt to modify, supersede, supplement or otherwise alter this Agreement, will not modify this Agreement or be binding on the Parties unless such terms have been fully approved in a signed writing by both the Chief Executive Officer of Ossium and an authorized representative of Customer. Additionally, in the event the Parties have entered into a separate non-disclosure agreement, the Parties intend that any terms and conditions between the Parties under such agreement are incorporated herein. In the event of an actual conflict between terms and conditions of such non-disclosure agreement and those of this Agreement, the terms and conditions of this Agreement exclusively govern and control solely with respect to that conflict.
2.3 Customer Requirements. Ossium will use commercially reasonable efforts to provide Customer with bone marrow donors with the characteristics identified in the mutually agreed Order Form as amended by the Parties from time to time.
2.4 Shipment of Products. Ossium will only ship Products to Customer upon receipt of all fees listed on the applicable Order Form. At the request of Customer, Ossium will ship Products to locations designated by Customer at Customer’s expense. Ossium will select the method of shipment, carrier, and logistics platform for the Products, and risk of loss and title to such shipped Products will pass to Customer upon delivery to Customer. Customer acknowledges and agrees that Ossium may contact Customer to confirm Customer’s receipt of shipped Products and that Customer will use its best efforts to provide such confirmation to Ossium in a prompt and timely manner.
2.5 Product Packaging and Storage. Ossium will package the Products in containers and with materials that are reasonable in accordance with industry standard. Customer will store bone marrow and Products in appropriate cryostorage conditions in accordance with the Technical Guidelines promptly upon receipt of shipment. Customer assumes all risks related to the storage of Products on and subsequent to the date of receipt by Customer. Customer may not return for credit or replacement Products for defects resulting from mishandling or improper storage by Customer or its agents.
2.6 Return of Products. Customer will not destroy and will return to Ossium any and all Products that have been damaged, thawed, delivered in error, or are otherwise unusable upon receipt by Customer (“Unusable Products”). Customer will not be eligible to receive a replacement or credit, as applicable, for returning Unusable Products to Ossium without submitting a written return material authorization (“RMA”). Upon receipt of an RMA, Ossium may credit or replace such Unusable Products in its sole discretion. For purposes of clarity, Ossium will not provide refunds for any reason.
2.7 Restrictions on Use. Customer agrees to only use the Products in accordance with the Technical Guidelines and only for internal use within the country specified in the applicable Order Form. Customer will be fully responsible for compliance with applicable Laws in the country where Customer uses the Products. Customer agrees not to engage in any of the following prohibited activities: (a) reselling, relabeling, or distributing Products; (b) using Products for in vivo testing or transplant in human subjects; (c) research, diagnostic or therapeutic purposes; (d) reverse engineering Products; (e) any activity in violation of Law; or (f) any other use in violation of the first sentence of this Section 2.7.
FEES AND CHARGES
3.1 Customer Fees. Customer will be responsible for all fees for Products shipped, applicable taxes, excise taxes, shipping, handling and inventory charges related to Customer’s orders for the Products (collectively, “Customer Fees”), in effect on the date of shipment. Prices and conditions are subject to change without notice.
3.2 Payments from Customer. Notwithstanding anything to the contrary herein, all amounts due under an Order Form will be due at the time that order is placed, before Ossium will ship any Products associated with such order to Customer. All information that Customer provides in connection with a purchase or transaction with Ossium must be accurate, complete, and current. Customer agrees to pay all charges incurred by users of Customer’s payment method used in connection with a purchase or transaction with Ossium at the prices in effect when such charges are incurred.
4.1 Intellectual Property Ownership. Ossium is the sole and exclusive owner of all right, title and interest in and to Intellectual Property used in the production of the Products and any and all related Data and Technical Guidelines (collectively, “Related Content”).
4.2 Related Content License. Subject to the terms and conditions of this Agreement and during the Term, Ossium hereby grants to Customer a limited, non-exclusive, non-transferable, non-sublicensable, royalty-free license to access and use the Related Content solely for Customer’s internal business use in connection with Products purchased hereunder. Any purpose or use not specifically authorized herein is prohibited unless otherwise agreed to in writing by Ossium.
4.3 Trademark License. Subject to the terms and conditions of this Agreement and during the Term, Ossium hereby grants to Customer a worldwide, non-exclusive, nontransferable, non-sublicensable, royalty-free license to display Ossium’s trademarks, logos, and other brand materials provided by Ossium (the “Ossium Brands”) solely for the purpose of identifying the Products as content provided by Ossium. Ossium Brands may not be modified or changed in any way, except with the prior written approval of Ossium. Relabeling, repackaging, misbranding, adulterating, diluting, and other alterations are not permitted. Tampering with, defacing, or otherwise altering identifying information on Products is prohibited. Customer will not remove or destroy any trademarks or other proprietary markings on the Products, documentation, or other materials related to the Products. Further, Customer may not remove or modify the contents of any label or literature on or accompanying the Product. Customer agrees to use the Ossium Brands in accordance with this Agreement and only for purposes specified herein. Customer agrees not to use Ossium Brands in any manner that is disparaging or otherwise portraying Ossium in a negative light. Ossium may revoke the license to use the Ossium Brands at any time by giving Customer a written notice. All uses by Customer of Ossium Brands will inure to the benefit of Ossium as the owner.
4.4 Reservation of Rights. Ossium reserves all rights not expressly granted to Customer in this Agreement. Except for the limited rights and licenses expressly granted under this Agreement, nothing in this Agreement grants, by implication, waiver, estoppel, or otherwise, to Customer or any third party any intellectual property rights or other right, title, or interest in or to the Related Content or Ossium Brands.
5.1 Indemnity. Customer will defend, indemnify and hold harmless Ossium and its Affiliates and successors, and its and their respective officers, directors, employees, distributors, representatives and agents from and against all losses, liabilities, claims, causes of action, or costs and expenses, including, without limitation, reasonable attorneys’ fees, brought or incurred by Ossium to the extent related to (a) a breach of the Agreement by Customer, (b) negligence, gross negligence or willful misconduct of Customer or its employees, agents or contractors, or (c) a failure by Customer or its employees, agents, contractors or invitees to comply with applicable laws and regulations.
5.2 LIMITATION OF LIABILITY. IN NO EVENT WILL OSSIUM OR ITS REPRESENTATIVES BE LIABLE, WHETHER AS A RESULT OF CONTRACTUAL BREACH, TORT OR OTHERWISE, TO CUSTOMER FOR ANY CONSEQUENTIAL, INDIRECT, SPECIAL, INCIDENTAL, EXEMPLARY, PUNITIVE, ENHANCED, OR LIQUIDATED DAMAGES INCURRED BY CUSTOMER, INCLUDING BUT NOT LIMITED TO INJURY TO GOODWILL, OR DIRECT, INDIRECT OR SPECULATIVE LOST PROFITS OR LOST REVENUES, REGARDLESS OF WHETHER SUCH DAMAGES WERE FORESEEABLE, WHETHER OR NOT CUSTOMER WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AND THE LEGAL OR EQUITABLE THEORY UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE. OSSIUM WILL NOT BE LIABLE FOR ANY CLAIMS ARISING FROM OSSIUM’S USE OF PRODUCTS IN ANY WAY OTHER THAN IN STRICT ACCORDANCE WITH THIS AGREEMENT. IN NO EVENT WILL OSSIUM’S AGGREGATE LIABILITY ARISING OUT OF OR RELATED TO THIS AGREEMENT UNDER ANY LEGAL OR EQUITABLE THEORY, INCLUDING, WITHOUT LIMITATION, BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY, AND OTHERWISE EXCEED THE TOTAL AMOUNTS PAID TO OSSIUM UNDER THE ORDER FORM PRECEDING THE EVENT GIVING RISE TO THE CLAIM OR $1,000, WHICHEVER IS LESS.
5.3 NO WARRANTIES. THE PRODUCTS ARE PROVIDED SOLELY “AS IS”, “AS AVAILABLE”, AND CUSTOMER’S USE OF THE PRODUCTS IS AT ITS OWN RISK. EXCEPT AS EXPRESSLY PROVIDED HEREIN, OSSIUM HEREBY DISCLAIMS ANY AND ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS, INCLUDING, WITHOUT LIMITATION, ANY WARRANTY OF NONINFRINGEMENT, MERCHANTABILITY, QUALITY, TITLE, FITNESS FOR A PARTICULAR PURPOSE, AND ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.
6.1 Confidentiality. During the Term and after expiration or termination of this Agreement, neither Party may disclose to any person or entity, directly or indirectly, without the prior approval of the other Party: (a) any of the terms and conditions of this Agreement, or (b) any Confidential Information of the other Party, except on a confidential basis to its employees (provided that such employees have a need to receive such information and are bound by non-use and non-disclosure obligations at least as protective as those in this Section), legal, financial or business advisors (provided that such disclosing party is responsible ensuring compliance by such advisors) or as required to be disclosed under applicable Law or by legal process (provided that the other Party is notified in advance and the disclosing Party provides assistance in limiting the disclosure). In addition, during the Term, each Party will not use the Confidential Information of the other Party or permit it to be accessed or used for any purpose other than to exercise its rights or perform its obligations under this Agreement. Each Party will protect and safeguard the other Party’s Confidential Information with the same degree of confidentiality as it affords its own sensitive business information, and in all cases with no less than reasonable care.
6.2 Disclosure Required by Law. Notwithstanding Section 6.1, a receiving Party may disclose the other Party’s Confidential Information if such information is required by Law to be disclosed in response to a valid order of a court of competent jurisdiction or authorized Governmental Authority, provided that the receiving Party must give the disclosing Party prompt written notice and obtain or allow for and reasonably cooperate with the disclosing Party to obtain a protective order prior to such disclosure.
6.3 Return of Copies. Upon termination of this Agreement, each Party will, upon the request of the other Party, return all copies, whether in paper, electronic, or other format, of all Confidential Information received by it from the other Party which contain the other Party’s Confidential Information, or destroy all of such documents and certify in writing the destruction thereof to the other Party, except that one copy thereof may be retained solely for archival or regulatory compliance purposes in the files of the counsel for the Party.
6.4 Remedies. In addition to any other rights or remedies, all of which will be deemed cumulative, a Party will be entitled to pursue injunctive relief to enforce the terms of such confidentiality provisions without the necessity of proof of damages or the posting of a bond or other security.
7.1 Assignment. This Agreement will be binding upon and will inure to the benefit of the Parties, and their respective successors and permitted assigns. Neither Party may transfer or assign this Agreement, in whole or in part, without the prior written consent of the other Party; provided, however, that either Party may freely assign this Agreement in the event of a merger, acquisition, or other form of sale of part or all of the assigning Party’s business to which this Agreement relates.
7.2 Product Feedback. Should Customer desire to submit a feedback to Ossium with respect to any Products, Customer will inform Ossium of such feedback and provide any information related to such feedback, including, without limitation, the Products’ unique identification number and a description of the nature of the defect(s) with reasonable specificity. At the request of Ossium, Customer will obtain additional information as reasonably requested by Ossium concerning such feedback. Any feedback provided pursuant to this Section will be Ossium’s Confidential Information.
7.3 Notices. All notices and other communications required or called for under this Agreement will be in writing, will be transmitted by email (with confirmation of transmission); overnight U.S. mail, postage prepaid; by certified or registered U.S. Mail, return receipt requested, postage prepaid; or by overnight Federal Express or another nationally recognized courier serviced (billed to sender) and will be deemed delivered when received by the Party to whom it is addressed at the below address or such other individual or address as such Party may give notice to the other Party, in advance, pursuant to these notice requirements:
|If to Customer:||If to Ossium:|
|Customer||Ossium Health, Inc.|
|[ADDRESS]||1121 Howard Street|
|[ADDRESS]||San Francisco, CA 94103|
|Attention: [NAME]||Attention: Kevin Caldwell|
|Email: [EMAIL]||Email: email@example.com
With a copy to:
7.4 Prior Dealings; Waiver. No previous course of dealing or performance or usage of trade not specifically set forth in this Agreement will be admissible to explain, modify or contradict this Agreement. Either Party’s failure to require performance by the other of any provisions hereof will in no way be deemed a waiver or affect the right of either Party to require such performance at any time thereafter.
7.5 Independent Contractors. This Agreement will not constitute either Party as an employee, agent, partner or legal representative of the other Party for any purpose, or give either Party any right to supervise or direct the functions of the other Party. Neither Party will have authority to act for or obligate the other Party in any way or to extend any representation or warranty on behalf of the other Party. Each Party agrees to perform under this Agreement solely as an independent contractor and will not hold itself out as an employee or agent of the other Party in any sense. Each Party agrees not to permit its employees or agents to do anything that might be construed or interpreted as acts of the other Party.
7.6 Severability. If any provisions of this Agreement should be or become fully or partly invalid or unenforceable for any reason whatsoever or violate any applicable Law, this Agreement is to be considered divisible as to such provision and such provision is to be deleted from this Agreement, and the remainder of this Agreement will be deemed valid and binding as if such provision were not included herein. There will be substituted for any such provision deemed to be deleted a suitable provision which, as far as legally possible, comes nearest to what the Parties desired according to the sense and purpose of this Agreement had this point been considered when concluding this Agreement.
7.7 Product Recalls. Ossium may institute and direct any recall, field corrective action, market withdrawal, stock recovery, or the like with respect to the Products (the “Recall Measures”). Customer will provide Ossium with full cooperation, as Ossium may reasonably request in connection with the Recall Measures.
7.8 Choice of Law. This Agreement will be governed by and construed and enforced in accordance with the laws of the State of California without reference to its conflicts of laws principles.
7.9 Survival. Termination, expiration, cancellation or abandonment of this Agreement through any means and for any reason will not relieve the Parties of any obligation accruing prior thereto, and will be without prejudice to the rights and remedies of either Party with respect to the antecedent breach of any of the provisions of this Agreement. The provisions of Articles 1, 2, 4-7, and such other necessary provisions and, insofar as orders for the Products are received by Customer prior to termination of this Agreement, will survive termination of this Agreement.
7.10 Force Majeure. If either Party is prevented from performing any of its obligations hereunder due to any cause which is beyond the non-performing Party’s reasonable control, including, without limitation, fire, explosion, flood, or other acts of God; acts, regulations, or Laws or application thereof; terrorism, war or civil commotion; strike, lock-out or labor disturbances; or failure of public utilities or common carrier (a “Force Majeure Event”), such non-performing Party will promptly give notice thereof to the other Party and will use reasonable commercial efforts to cure or correct any such Force Majeure Event and to resume performance of its affected obligations as soon as possible.
7.11 Headings. The headings included in this Agreement are for reference purposes only and will not affect the meaning or interpretation of this Agreement.
7.12 Representations and Warranties. Each of the Parties represents and warrants that (a) it is fully authorized to enter into this Agreement; and (b) its entering into and performance under this Agreement does not violate or breach its certificate of incorporation or corporate bylaws or any agreement or contract to which it is a party. Ossium will make available to Customer a Material Safety Data Sheet (“MSDS”) for each Product delivered to Customer, if applicable. Customer will follow all precautions and requirements listed in the MSDS at all times and will require such compliance from its agents.
7.13 Multiple Counterparts. This Agreement may be executed in multiple counterparts (including those delivered by facsimile or other electronic means), each of which will be deemed to be an original instrument, but both such counterparts together will constitute one agreement.
7.14 Interest in Human Tissue. The Parties acknowledge that the Products are derived from human donated tissue and that human donated tissue can neither be owned nor sold by any individual or company by federal law. During the recovery, processing, promotion, distribution, delivery, and supply of the Products, Customer will invest resources and add significant value to the human donated tissue. The Customer Fees paid to Customer by Ossium are in recognition of and are compensation for the services provided by Ossium.
7. 15 Successors and Assigns. All references in this Agreement to rights or obligations of Ossium with respect to the Products will also be deemed to include permitted successors and assigns of Ossium. All references in this Agreement to rights or obligations of Customer with respect to the Products will also be deemed to include permitted successors and assigns of Customer.
7.16 Debarment. Each Party represents, warrants and covenants to the other Party that it has never been, is not currently, and, during the Term, will not become, a Debarred Entity, Excluded Entity or Convicted Entity. Ossium further warrants and represents that no Debarred Individual, Debarred Entity, Excluded Individual, Excluded Entity, Convicted Individual or Convicted Entity has performed or rendered, or will perform or render, any services or assistance on its behalf relating to activities taken pursuant to this Agreement.
a. A “Debarred Individual” is an individual who has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from providing services in any capacity to a person that has an approved or pending drug product application, or an employer, employee or partner of a Debarred Individual.
b. A “Debarred Entity” is a corporation, partnership or association that has been debarred by the FDA pursuant to 21 U.S.C. §335a (a) or (b) from submitting or assisting in the submission of any abbreviated drug application, or an employee, partner, shareholder, member, subsidiary or affiliate of a Debarred Entity.
c. An “Excluded Individual” or “Excluded Entity” is (i) an individual or entity, as applicable, who has been excluded, debarred or suspended by the Office of the Inspector General (OIG/HHS) of the U.S. Department of Health and Human Services, or (ii) is an individual or entity, as applicable, who has been excluded, debarred, or suspended from participating in federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration (GSA).
d. A “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who has been convicted of a criminal offense that falls within the ambit of 42 U.S.C. §1320a – 7(a), but has not yet been excluded, debarred, suspended or otherwise declared ineligible.
e. If any of the foregoing warranties or representations becomes untrue (by way of example only, if a Party or any individual or entity performing services on its behalf hereunder becomes excluded, debarred or suspended after the Effective Date of this Agreement), such Party will immediately notify the other Party and this will constitute grounds for immediate termination by the other Party.