1. Scope of Work. iQ Biosciences shall render the study and/or services (“Services”) as set forth in a Proposal, Protocol, Statement/Scope of Work or Work Order (each, a “Supporting Document” and collectively, “Supporting Documents”). The Supporting Documents when signed by iQ Biosciences and Customer/Sponsor are subject to these Terms and Conditions of Service (“Terms of Service”). The Supporting Documents together with these Terms of Service are sometimes referred to herein as “Agreement”. In the event of a conflict or inconsistency between the terms contained in the Supporting Documents and these Terms of Service, the former shall govern, except in the case of any Customer non-negotiated standard or preprinted terms. Notwithstanding anything to the contrary herein or in the Supporting Documents, any Customer preprinted terms or conditions included in any communication or document relating this Agreement, including on purchase orders, change orders, or other documentation are hereby specifically rejected.
2. Conduct of Services/Study.
2.1. iQ Biosciences will maintain industry standards of professional conduct in the performance of the Services and in the preparation of all related reports. iQ Biosciences and Sponsor will adhere to all material government laws, rules and regulations applicable to the conduct of the Study (“Applicable Law”).
2.2. iQ Biosciences will conduct the Study in accordance with the Supporting Documents, which may be amended from time to time upon the mutual agreement of iQ Biosciences and Sponsor. iQ Biosciences agrees not to intentionally change or deviate in any material manner from the Supporting Documents without Sponsor’s prior approval. Deviations from the Supporting Documents may be made in an emergency without Sponsor’s approval, provided that iQ Biosciences shall use commercially reasonable efforts to obtain Sponsor’s verbal approval, which shall be subsequently confirmed by Sponsor in writing. The parties acknowledge that during the course of performing the Study in accordance with the Supporting Documents, additional costs may be incurred by iQ Biosciences as a result of procedural changes which do not amount to or require a change in the Supporting Documents, but which are deemed necessary by iQ Biosciences to successfully perform said Study, and which could not be foreseen at the time of the preparation of the Supporting Documents. If such procedural changes occur, iQ Biosciences shall advise the Sponsor prior to their implementation and solicit the Sponsor’s agreement as to the necessity and additional cost thereof. Should iQ Biosciences be unable to contact the Sponsor in advance, the Sponsor agrees that in order to maintain the integrity of the Study, iQ Biosciences may proceed accordingly and be entitled to recover documented additional costs from the Sponsor upon presentation of an explanation of such procedural changes and the necessity thereof.
2.3. After the Study has been completed, iQ Biosciences may be requested by Sponsor to provide additional consultation services concerning the Study. Upon such a request by Sponsor, iQ Biosciences will provide the requested services and will be paid an amount mutually agreed to by the parties. These consultation services will be subject to the provisions on Confidentiality and Ownership set forth in Sections 8 and 13, respectively.
2.4. iQ Biosciences may elect to subcontract any part of the Services to a third party without having to obtain the Sponsor’s prior consent provided that:
(i) such subcontracted Services are agreed in the relevant Supporting Documents;
(ii) such Services are performed in accordance with this Agreement, including confidentiality provisions, and the relevant Supporting Documents; and
(iii) iQ Biosciences shall remain fully responsible to the Sponsor for the performance of such Services.
In the event that iQ Biosciences subcontracts any part of the Services to an affiliated entity, invoices for such Services may be issued to the Sponsor directly by the affiliated entity in the currency specified in the relevant Supporting Documents or as otherwise agreed in writing between the parties. The Sponsor shall pay such invoices directly to the relevant affiliated entity.
3. Test Articles. If applicable, Sponsor will provide iQ Biosciences with sufficient amounts of all compounds, materials, or other substances meeting relevant specifications (“Test Articles”) with which to perform the Study, if applicable, such complete and accurate data as is necessary to apprise iQ Biosciences of the identity, strength, purity, stability and composition or other appropriate characteristics of each batch, proper storage and safe handling requirements of the Test Articles, including a Material Safety Data Sheet (MSDS) or equivalent documentation. In addition, if applicable, Sponsor will provide iQ Biosciences certification that the methods of synthesis, fabrication, or derivation of the Test Article have been documented by the Sponsor. All costs associated with shipping the Test Articles to iQ Biosciences shall be the responsibility of Sponsor, and iQ Biosciences shall not be responsible for any loss, damage or destruction of the Test Articles while in transit.
4. Personnel. iQ Biosciences will arrange for qualified personnel to support iQ Biosciences’ obligations under this Agreement. To the best of iQ Biosciences’ knowledge, iQ Biosciences represents that none of its employees who are to participate in a Study have been debarred and none of such employees are under consideration to be debarred by the Food and Drug Administration from working in or providing services to any pharmaceutical or biotechnology iQ Biosciences under the Generic Drug Enforcement Act of 1992, as amended.
5.1. Upon reasonable advance notice, iQ Biosciences will permit Sponsor and/or its designated representatives (provided such representatives are not competitors of iQ Biosciences), during normal business hours and at mutually agreeable times, to visit the iQ Biosciences facilities where the Study is taking place to monitor iQ Biosciences’ performance of the Study. During the visit, iQ Biosciences may require Sponsor designees to be accompanied by a Company representative and ensure such designees are covered by or execute an appropriate confidentiality agreement.
5.2. iQ Biosciences will notify Sponsor as soon as practical in the event of any regulatory inspection of iQ Biosciences’ facilities that directly impacts a Study. In the event of an inspection of Sponsor’s Study by a regulatory or administrative agency, iQ Biosciences will, to the extent permissible under Applicable Law, consult with and allow Sponsor to review and comment on any responses to such agency related to the inspection.
5.3. To the extent that Sponsor engages a third party to perform any services related to a Study, Sponsor shall provide all information requested by iQ Biosciences regarding such services, including, without limitation, all information regarding regulatory and quality assurance sufficient to enable iQ Biosciences to comply with its own regulatory and/or quality assurance obligations. If any study activities are subcontracted by Sponsor, Sponsor will be responsible for qualification of these subcontractors to assure they meet all required standards and regulations.
6. Records and Reports.
6.1. iQ Biosciences will keep complete and accurate records of the status and progress of the Study as required by the Supporting Documents.
6.2. Provided that the Sponsor is not in default hereunder or under any of the Supporting Documents, iQ Biosciences will furnish a draft report or data containing information specified in the Supporting Documents (all reports will be prepared in iQ Biosciences’ standard format unless otherwise specified in the Supporting Documents or as otherwise agreed to by the parties). The Sponsor shall promptly review the draft report and propose in writing its suggested modifications, if any, within 14 business days of the receipt of the draft report, whereupon iQ Biosciences shall issue a final report, reasonably taking into consideration such suggested modifications. If the Sponsor has not suggested any modifications within 14 business days of the receipt of the draft report, the Sponsor will be deemed to have accepted such report as final.
6.3. All raw data, study documentation, protocols, interim and final reports, specimens generated as a result of a preclinical Study are the Sponsor’s property. At Sponsor’s cost and expense, if Applicable Law or Sponsor requires Sponsor’s property to be held by iQ Biosciences, iQ Biosciences shall store Sponsor’s property as agreed upon in the Supporting Documents and in accordance with iQ Biosciences’ Standard Archiving Terms and Conditions which may be accessed via iQ Biosciences’ website and made a part hereof. Upon reasonable advance notice, provided that the Sponsor is not in default hereunder or under any of the Supporting Documents, Sponsor shall have reasonable access to such material, and shall have the right to obtain copies of the raw data and supporting documentation, at Sponsor’s expense.
7.1. Sponsor will pay iQ Biosciences as set forth in the Supporting Documents (“Study Price”). All invoices are due and payable thirty (30) days from the date of the invoice, and Sponsor agrees to pay all invoices submitted. All amounts not paid by Sponsor when due shall accrue interest from the applicable due date until paid, at the rate of one- and one-half percent (1.5%) per month. Sponsor will be liable for payment of any and all costs and expenses incurred by iQ Biosciences in the collection of any overdue payment amount, including, without limitation, any costs and expenses incurred by iQ Biosciences resulting from the use of a third-party collection agency. iQ Biosciences may elect to cease or suspend work on a Study or withhold required reports or other deliverables if the Sponsor does not make payments when due and payable.
7.2. All applicable termination, delay, suspension or cancellation fees will be set forth in the Supporting Documents.
7.3. Sponsor and iQ Biosciences agree that neither Sponsor nor iQ Biosciences should receive a benefit or a detriment from differences arising from variations between foreign currency exchange rates for the currencies used for this project and those existing at the dates of the actual invoices, as published in the Wall Street Journal. If such a difference is larger than +/- 5%, Sponsor and iQ Biosciences have the right to request a re-evaluation of the future billing rates based on the work performed by iQ Biosciences after such a difference is observed.
7.4. If in the judgment of iQ Biosciences, Sponsor’s financial condition is precarious or there has been a materially adverse change in Sponsor’s financial condition, iQ Biosciences shall have the right to demand payment or other assurances which it deems adequate before providing any additional Services.
7.5. All Value Added Taxes, sales taxes and any other taxes required by Applicable Law shall be paid by Sponsor.
8.1 The parties may exchange proprietary and confidential information during the term of this Agreement, including without limitation, the existence and terms of this Agreement. The parties will identify, in writing, such information as confidential and/or proprietary. If a party intends to disclose confidential information to the other party orally, the disclosing party shall (i) alert the other party of the confidential nature of the disclosure prior to the disclosure and (ii) provide written notice to the other party of the confidential nature and contents of such disclosure within ten (10) days of the original disclosure. Notwithstanding the foregoing, information which is orally or visually disclosed to the receiving party by the disclosing party, or is disclosed in writing without an appropriate letter, proprietary stamp or legend, shall constitute confidential information, provided that the confidential nature of such information would be apparent to a reasonable person, familiar with the disclosing party’s business and industry in which it operates. Each party will use its commercially reasonable efforts to maintain such information in confidence and will employ reasonable and appropriate procedures to prevent its unauthorized publication or disclosure. Except as expressly authorized in writing, neither party shall use the other party’s proprietary or confidential information for any purpose other than in performance of this Agreement. In the event of site visits to the other party’s facilities, each party agrees to protect any confidential information with which each party’s representatives may come in contact, by any means and for whatever purpose, during visits to the other party’s facilities. Each party agrees to communicate the substance of this provision to any of its employees and representatives that will be visiting the other party’s facilities. The obligations of confidentiality set forth in this Section 8 will survive the termination or expiration of this Agreement for a period of five (5) years.
8.2. The confidentiality provisions of this Section 8 shall not apply to any part of such information, which:
a) is known to the receiving party at the time it was obtained from the disclosing party;
b) is acquired by the receiving party from a third party, and such third party did not obtain such information directly or indirectly from the disclosing party under an obligation not to disclose;
c) is or becomes published or otherwise in the public domain other than by violation of this Agreement by the receiving party;
d) is independently developed by the receiving party without reference to or reliance upon the information provided by the disclosing party; or
e) is required to be disclosed by the receiving party to comply with applicable laws or governmental regulations; provided that the receiving party provides prompt written notice of such disclosure to the disclosing party and cooperates with the disclosing party’s reasonable and lawful actions to avoid and/or minimize the extent of such disclosure.
8.3. The parties agree that confidential information is not deemed to be in the public domain merely because any part of the information is embodied in general disclosures or because individual features, components, or combinations are now, or become, known to the public.
9. Use of Names. Neither party will use the other party’s name or the name of any employee of the other party in any advertising, packaging, promotional material, or any other publicity relating to this Agreement, without the prior written approval of the other party.
10.1. Sponsor warrants that it owns all rights, title and interest in or otherwise has the right to use the Test Articles and the intellectual property related thereto, and to the best of Sponsor’s knowledge, that iQ Biosciences’ use of any and all such Test Articles in connection with any Study will not infringe the intellectual property rights of any third party.
10.2. iQ Biosciences warrants that the Services shall conform to the specifications set forth in the Supporting Documents and the current material applicable standards, regulations and procedures of the appropriate regulatory agencies. iQ Biosciences does not warrant or represent that the results of the Study will be acceptable to any regulatory or governmental agency to which they are presented nor that the results of the Study will enable the Sponsor to further develop, market or otherwise exploit the Test Articles or any other product or service.
10.3. THE WARRANTY BY SPONSOR SET FORTH IN SECTION 10.1 ABOVE, AND iQ BIOSCIENCES SET FORTH IN SECTION 10.2 ABOVE IS IN LIEU OF ANY AND ALL OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS, IMPLIED OR STATUTORY INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR FOR NON-INFRINGEMENT OF A PATENT, TRADEMARK OR OTHER INTELLECTUAL PROPERTY RIGHT.
11. Limitation of Liability.
11.1. Neither Sponsor nor iQ Biosciences will be liable to the other Party for penalties or liquidated damages or for special, indirect, consequential, punitive, exemplary or incidental damages of any type or kind (including, without limitation, lost profits) regardless of whether any such losses or damages are characterized as arising from breach of contract, breach of warranty, tort, negligence, strict liability or otherwise, even if Sponsor or iQ Biosciences is advised of the possibility of such losses or damages, or if such losses or damages are foreseeable.
11.2. iQ Biosciences’ liability under this Agreement, regardless of the form of action, shall be limited to actual damages and shall not exceed the total amount paid for the Study under which such liability arises. In no event shall iQ Biosciences be liable for any damages arising from or in connection with any decision by Sponsor or any third party to further research, develop or market the Test Articles or any derivative or product or service related thereto or the use of the Test Articles or any product or derivative or service related thereto.
11.3. Subject to the limitations set forth in this Section 11, in the event that iQ Biosciences commits a breach of the warranty set forth in Section 10.2 above, iQ Biosciences’ sole liability, and Sponsor’s sole remedy shall be for iQ Biosciences to conform, at iQ Biosciences’ cost and expense, the affected work or portion of the research affected by the breach to the relevant specification.
12.1. Subject to the limitations of liability contained in Section 11 above, iQ Biosciences will defend, indemnify, save and hold harmless Sponsor and its parent, subsidiaries and affiliates and their respective directors, officers, employees and agents from and against any claims, demands, suits, actions, causes of action, losses, damages, fines and liabilities, including without limitation reasonable attorneys’ fees and any costs and expenses associated with each party’s compliance with a subpoena or other similar legal request related to a Study (“Claims”) arising out of or in connection with or attributable to iQ Biosciences’ gross negligence or willful misconduct in performance of the Study, and will pay any costs and damages which may be assessed against them, provided that iQ Biosciences is given written notice of the Claims within five (5) days of the date of notice to Sponsor and is given information, reasonable assistance, and sole authority to defend and/or settle the claim.
12.2. Sponsor will defend, indemnify, save and hold harmless iQ Biosciences and its parent, subsidiaries and affiliates and their respective directors, officers, employees and agents from and against any third party Claims arising out of or in connection with or attributable to (a) the research, development, manufacture, distribution, use, sales or other disposition by Sponsor, or any distributor, collaborator, customer, sublicensee, contractor, subcontractor, representative or agent of Sponsor, of the Test Articles and/or any other substances upon which the services of iQ Biosciences were performed, or (b) any infringement of any third party’s patent rights or unauthorized use or misappropriation of its know-how related to the Study, or (c) personal injury to Sponsor’s employees related to contact with tissues, samples or specimens during visits to iQ Biosciences’ facilities or after delivery of any tissues, samples or specimens to Sponsor, or (d) Sponsor’s breach of this Agreement, gross negligence or willful misconduct in connection with this Agreement and will pay any costs and damages which may be assessed against them, provided that Sponsor is given written notice of the Claims within five (5) days of the date of notice to iQ Biosciences and is given information, reasonable assistance and sole authority to defend and/or settle the claim.
13. Ownership. Any inventions and/or techniques for carrying out the Services hereunder which relate to the conduct of iQ Biosciences’ business are and shall remain iQ Biosciences’ exclusive property, including but not limited to; present and future documentation, scientific and technical data, test procedures and other information that is owned or licensed by iQ Biosciences and that is not developed hereunder. Subject to the terms and conditions hereof, iQ Biosciences shall have the right to use concurrent control data as part of its general historical database. Any data, discoveries or inventions developed or generated pursuant to this Agreement which directly relate to any information or materials provided by Sponsor hereunder, including without limitation new data, uses, processes or compositions directly relating to the information or materials provided hereunder shall be the exclusive property of Sponsor. iQ Biosciences agrees to assist Sponsor in securing for Sponsor any patents, copyrights or other proprietary rights in such data, discoveries or inventions, and to perform all acts that may be reasonably required to vest in Sponsor all right, title and interest in such data, discoveries or inventions, and iQ Biosciences shall be compensated for such assistance. All costs and expenses associated with establishing Sponsor’s rights therein shall be Sponsor’s responsibility.
14. Insurance. Each party shall carry and provide to the other upon request, a copy of its insurance certificate evidencing insurance sufficient to cover its interest or potential liabilities hereunder including, but not limited to worker’s compensation, if applicable, and comprehensive general liability.
15. Force Majeure. Except with respect to the payment of monies due hereunder, neither party shall be considered in default of the performance of any obligation hereunder to the extent that the performance of such obligation is prevented or delayed by fire, flood, earthquake, hurricane, explosion, disease, contamination, strike, labor or material shortages, acts of terrorism, war, insurrection, embargo, government requirement, civil or military authority, act of God, or any other event, occurrence or condition which is not caused, in whole or in part, by that party, and which is beyond the reasonable control of that party.
16. Termination of Study.
16.1. Termination by Sponsor Without Cause. After payment of the Milestone 1 Payment, Sponsor shall have the option to terminate an on-going Study at any time without cause upon thirty (30) days prior written notice to iQ Biosciences. In the event a Study is terminated without cause, except in cases in which the Supporting Documents set forth an agreed Early Termination Fee, iQ Biosciences shall retain as non-refundable the Milestone Payments paid through the effective date of termination, together with any additional expenses incurred in connection with the shutdown of the Study including without limitation any irrevocably committed costs and a reasonable amount corresponding to the allocation of iQ Biosciences’ resources.
16.2. Termination by iQ Biosciences Without Cause. iQ Biosciences may terminate this Agreement without cause upon sixty (60) days’ prior written notice to Sponsor, provided that iQ Biosciences completes all Studies in progress, and Sponsor makes all payments due to iQ Biosciences through the effective termination date.
16.3. Termination by Either Party for Cause. Either party may terminate this Agreement at any time upon thirty (30) days prior written notice to the other party, for material breach of this Agreement by the other party if such breach is not remedied to the non-breaching party’s reasonable satisfaction within the thirty (30) day period following receipt of the written notice of breach. The notice required under this section must state sufficient specificity as to the nature of the breach to enable the breaching party to understand the steps required to cure. In the event the nature of the breach is such that more than 30 days is reasonably required to cure, such time frame shall be reasonably extended not to exceed 90 days.
Upon termination, neither party will have any further obligations to the other, except that (i) the liabilities accrued through the date of termination and (ii) the obligations which by their terms survive termination, including the applicable confidentiality, record keeping, regulatory compliance, intellectual property and indemnification provisions of these Service Terms, shall survive termination.
17. Employee Solicitation. Sponsor agrees that, during the term of a Study and for a period of one hundred eighty (180) days thereafter, Sponsor will not solicit for hire or hire as an employee, or engage as an independent contractor, any person who has been involved in rendering services on the Study, without the prior written consent of iQ Biosciences.
18. Dispute Resolution. The parties shall attempt, in good faith, to resolve through negotiations any controversy, claim, or dispute arising out of this Agreement. In the event that negotiations are not successful, the controversy, claim or dispute shall be submitted to third party mediation upon terms reasonably acceptable to the parties. If such claim, controversy or dispute is not resolved through mediation, upon written demand of either party, the claim, controversy or dispute shall be submitted to arbitration. Such arbitration shall take place in the jurisdiction in which the services are provided, and shall proceed in accordance with the laws of such jurisdiction and the Commercial Arbitration Rules of the American Arbitration Association or if the parties so elect, the Rules of the United Nations Commission on International Trade Law Model Law on International Commercial Arbitration. A record and transcript of the proceedings shall be maintained. Any award shall be made in writing and in reasonable detail, setting forth the findings of fact and conclusion of law supporting the award. The determination of a majority of the panel of arbitrators shall be the decision of the arbitrators, which shall be binding regardless of whether one of the parties fails or refuses to participate in the arbitration. The decision shall be enforceable by a court of law, provided that the decision is supported by substantial fact and is without material error of law. All costs of such arbitration, except expert fees and attorneys’ fees, shall be shared equally by the parties.
19.1. Notices. All notices from one party to the other will be in writing and will be delivered by addressing the same, to the applicable address of the party set forth in the Supporting Documents, or at such other address as either party may specify in writing to the other. Notices shall be sent by overnight courier, certified mail, return receipt requested, email acknowledged by recipient, or by other means of delivery requiring a written acknowledged receipt. All notices shall be effective upon receipt.
19.2. Independent Contractor. The business relationship of iQ Biosciences to the Sponsor is that of an independent contractor and not of a partner, joint venturer, employer, employee or any other kind of relationship. iQ Biosciences will be solely responsible for expenses and liabilities associated with the employment of its employees.
19.3. Assignment. This Agreement, and the rights and obligations hereunder, may not be assigned or transferred by either party without the prior written consent of the other party, except that either party may assign this Agreement to an affiliated entity or in connection with the merger, consolidation or sale of substantially all its assets related to the Study.
19.4. Entire Agreement. These Service Terms, together with the Supporting Documents, set forth the entire agreement and understanding between the parties, superseding any and all previous statements, negotiations, documents agreements and understandings, whether oral or written, as to the subject matter of the Agreement. No modification or waiver of the provisions of this Agreement shall be valid or binding on either party unless in writing and signed by both parties. No waiver of any term, right or condition under this Agreement on any one occasion shall be construed or deemed to be a waiver or continuing waiver of any such term, right or condition on any subsequent occasion or a waiver of any other term, right or condition hereunder.
19.5. Severability. In the event that any one or more of the provisions contained in this Agreement is for any reason held to be invalid, illegal or unenforceable in any respect, that invalidity, illegality or unenforceability will not affect any other provisions of this Agreement, and all other provisions will remain in full force and effect. If any provision of this Agreement is held to be excessively broad, it will be reformed and construed by limiting and reducing it so as to be enforceable to the maximum extent permitted by law.
19.6. Applicable Law. This Agreement will in all events and for all purposes be governed by, and construed in accordance with, the laws of the State of California, without regard to any choice of law principle that would dictate the application of the law of another jurisdiction.
19.7. Recoverable Expenses. In the event any legal action is instituted to enforce any of the terms and provisions of the Agreement, the prevailing party in such legal action shall be entitled to recover all of its attorney’s fees and all other costs of litigation.
19.8. Language of Agreement. The parties acknowledge that it is their express wish that this Agreement and all notices and other documents to be given or executed pursuant hereto be in English.
Last Updated: May 25, 2022