Last revised on December 20, 2022
Pivot Bio Field Trials Master Service Agreement
This Field Trials Master Services Agreement (the “Agreement”) is incorporated by reference into each statement of work, including any exhibits or protocols attached thereto, (collectively, the “Statement of Work”) that a service provider (“Service Provider”) may enter into with Pivot Bio, Inc., with offices located at 2910 7th Street, Berkeley, CA 94710 (“Pivot”). Pivot and Service Provider may each be referred to herein as a “Party” or collectively as the “Parties.”
THIS IS A LEGAL AND ENFORCEABLE CONTRACT BETWEEN PIVOT AND SERVICE PROVIDER. SERVICE PROVIDER IS RESPONSIBLE FOR CAREFULLY READING ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT BEFORE SIGNING A STATEMENT OF WORK. BY SIGNING A STATEMENT OF WORK, SERVICE PROVIDER CONFIRMS THAT SERVICE PROVIDER HAS ACCESSED ONLINE AND/OR BEEN PROVIDED A COPY OF THIS AGREEMENT AND THE STATEMENT OF WORK AND HAS READ AND ACCEPTS ALL OF THE TERMS AND CONDITIONS OF THIS AGREEMENT AND THE STATEMENT OF WORK IN THEIR ENTIRETY. SERVICE PROVIDER ACKNOWLEDGES THAT THE TERMS AND CONDITIONS OF THE STATEMENT OF WORK ARE INCORPORATED BY REFERENCE INTO THIS DOCUMENT AS IF SET FORTH FULLY HEREIN.
Pivot reserves the right to change, update, and modify this Agreement at any time. Service Provider is bound to the version that is current as of the date of execution of the applicable Statement of Work.
1. Statement of Work. Service Provider will perform the services (the “Services”) in accordance with the applicable Statement of Work. The applicable Statement of Work together with the Agreement shall constitute the entire agreement for Pivot’s receipt of the Services. To the extent any terms in a Statement of Work conflicts with the terms in this Agreement, the terms of this Agreement shall control unless otherwise expressly agreed by the Parties in such Statement of Work.
2.1 Diligence. Service Provider shall, and shall ensure that any Authorized Representatives (as defined in Section 2.2) agree to: (a) diligently complete the Services described in each Statement of Work and, if applicable, provide Samples, reports, notes, data assessments, documentation, methods, results, conclusions, data and information to the extent described in the Statement of Work or accompanying protocol (the “Deliverables”) to Pivot, (b) fully comply with any Specifications, the applicable Statement of Work, standard operating procedures provided by Pivot in writing and any professional standards, regulatory authority requirements applicable to the Services, and all other applicable laws, rules and regulations (“Applicable Law”), and (c) complete its obligations in the timeframe specified in the Statement of Work. “Sample” means root and plant material (including any soil adhered to such), soil, and any microbes present on or within soil, root material, and/or plant material. “Specifications” means any requirements, guidelines and other specifications set forth in the applicable Statement of Work or accompanying protocol.
2.2. Authorized Representatives. Subject to Section 7 below, Service Provider shall only allow Service Provider’s employee(s), personnel, consultant(s), partner(s), agent(s), representative(s), subcontractor(s), or authorized providers who will also provide the Services described under a Statement of Work, as applicable (“Authorized Representatives”) to perform the Services and to have access to Pivot Confidential Information (including without limitation, Deliverables, Materials, Project Technology and Pivot Background IP (each as defined below)). Service Provider shall ensure that Authorized Representatives agree to be or are otherwise bound by the obligations of confidentiality and non-use herein.
2.3. Subcontractors. Service Provider shall not assign, delegate, or subcontract any Services without the prior written approval of Pivot. Such approval shall not relieve Service Provider of its obligations under this Agreement and Service Provider shall remain responsible for the performance of its subcontractors under this Agreement.
2.4. Records; Further Assurances; and Inspections.
a) Records. In connection with the Services and in addition to any reporting and record-keeping requirements included in a Statement of Work, Service Provider shall, and ensure that any Authorized Representatives shall: (1) maintain accurate and complete records and data relating to the Services (“Records”) in accordance with Applicable Laws and industry practice; and (2) ensure that Service Provider and, if applicable, any Authorized Representatives reduce to writing and promptly provide Pivot with Records and Deliverables upon Pivot’s request.
b) Fields. During the Term, Pivot or its representative(s) upon reasonable prior written notice and at Pivot’s expense, shall have the right, during Service Provider’s regular business hours, to: (1) inspect Service Provider’s fields with respect to Services performed under a Statement of Work; and (2) audit, inspect and copy any Records relating to the Services. Service Provider agrees to permit any appropriate regulatory agency or body access to its fields and records as may be required by Applicable Laws.
3. Acceptance of Deliverables.
3.1 Acceptance. To the extent that a Deliverable fails to conform to the Specifications, Pivot shall provide written notification of such non-conformance to Service Provider within forty-five (45) days (unless the Parties agree upon some other period in a Statement of Work) of receiving said Deliverable (“Notice”). Such Notice shall specify the particular Specification(s), with which the Deliverable does not comply. Within ten (10) business days of receipt of a Notice, Service Provider shall submit a plan to correct any deficiencies and use its best efforts to correct any deficiencies by either, at Pivot’s option, (a) correcting and re-submitting the Deliverable for acceptance or (b) reimbursing Pivot for all payments made by Pivot to Service Provider for the deficient Deliverable. A re-submitted Deliverable shall be subject to the same acceptance procedure. No additional payments and fees will be due to Service Provider for re-performance pursuant to this Section 3.1.
4. Compensation and Payment.
4.1 In consideration for the Services, Pivot shall pay Service Provider in accordance with the payment schedule (the “Payment Schedule”) in the applicable Statement of Work.
4.2. Service Provider shall invoice Pivot for completed Services as provided in the applicable Statement of Work. Service Provider shall send invoices to email@example.com with cc: to the individual Pivot contact referenced in the applicable Statement of Work and contain, at minimum, an itemized list of Services completed and calculation of the price for such Services in accordance with the Payment Schedule. Pivot shall pay each undisputed invoice no later than thirty (30) days following its receipt thereof (Net 30).
4.3. Payments to Service Provider shall be made to the name and address provided by Service Provider in the Statement of Work.
4.4. Taxes (and any penalties and interest thereon) imposed on any payment made by Pivot to Service Provider shall be the responsibility of Service Provider.
5. Term and Termination.
5.1. The Agreement shall commence on the Effective Date set forth in the Statement of Work and, unless earlier terminated in accordance with this Agreement, continue until the later of: (a) completion of the Services under all Statements of Work, or (b) as stated in an applicable Statement of Work (the “Term”). The Parties may mutually agree in writing to extend the Term.
5.2. This Agreement or any Statement of Work may be terminated by Pivot, without cause, upon thirty (30) days’ notice to Service Provider.
5.3. This Agreement may be terminated by either Party for material breach by the other Party, provided that the terminating Party has given the breaching Party written notice of the breach and at least thirty (30) days to cure the breach prior to the effective date of termination.
5.4. Upon the effective date of termination, Service Provider shall provide an accounting of costs and Expenses related to the Agreement and/or applicable Statement of Work, subject to verification by Pivot. Within thirty (30) days after receipt of adequate documentation, Pivot shall make a payment to Service Provider (and/or Service Provider may retain related fees previously paid by Pivot) for Services (a) approved by Pivot in a Statement of Work or other prior written authorization incurred by Service Provider in performing the Services until the effective date of termination and/or (b) reasonable, non-cancelable obligations properly incurred for the Services and approved by Pivot in a Statement of Work and, in each case of (a) or (b), completed in accordance with this Agreement. To the extent Pivot objects to any fee(s), the Parties shall promptly resolve any disagreement in good faith. Except as provided in this Section 5.4, Pivot shall have no obligation to pay Service Provider for (y) Services performed after the date of termination; or (z) fees or expenses not otherwise approved by Pivot in writing.
5.5. Service Provider will return any funds paid to Service Provider by Pivot in excess of the amount due under Section 5.4 within thirty (30) days of termination.
5.6. If this Agreement is terminated prior to completion of the Services, in addition to those obligations set forth in Section 5.7 below, Service Provider shall deliver to Pivot any partial or completed Deliverables created pursuant to this Agreement. Service Provider agrees to assist Pivot with transferring responsibilities to Pivot or another designated third party upon Pivot’s reasonable request.
5.7. Upon request, expiration, or termination of this Agreement, Service Provider will promptly return or destroy (at Pivot’s option) all Confidential Information to Pivot, including but not limited to Deliverables and Materials, together with all copies of any of the foregoing. Notwithstanding such return, Service Provider shall be bound by the confidentiality obligations in Section 7 for five (5) years after the expiration or termination of this Agreement. Notwithstanding the foregoing, such obligations shall survive with respect to any trade secrets for so long as any Confidential Information remains a trade secret under applicable law.
5.8. Sections 2.4(a), 4.2 to 4.4 and 5.4 to 5.7 (with respect to Section 5.7, solely for five (5) years), and Sections 6 to 11 hereof shall survive expiration or termination of this Agreement.
6.1. During the Term, Pivot may transfer to Service Provider quantities of materials as may be identified in the applicable Statement of Work (“Materials”) for the sole purpose of performing the Services in the fields of Service Provider or other location(s) expressly approved by Pivot. Service Provider and/or Authorized Representatives (as applicable) may only use the Materials to perform the Services under the Statement of Work pursuant to which they were provided, and not for any other purpose without Pivot’s prior written consent. Unless otherwise expressly agreed by the Parties, (a) Service Provider agrees to retain control over the Materials and to not transfer Materials to any other third party other than Authorized Representatives, and (b) Authorized Representatives may only have access to the Materials under the direct supervision of Service Provider.
6.2. Pivot shall retain all right, title, and interest in and to the Materials. Nothing herein shall be construed (a) to prevent Pivot at any time from using or disclosing the Materials, (b) as a grant by Pivot to Service Provider of any license or other ownership interest in or to the Materials, or (c) to obligate Pivot to enter into any further agreement with Service Provider relating to the Materials. Service Provider may not undertake efforts (including but not limited to NMR, UV, IR, x-ray crystallography and mass spectroscopy and similar analyses) to ascertain the structure of any Materials provided hereunder without the prior written permission of Pivot. Service Provider shall not reverse engineer, disassemble or decompile any Materials or any other composition, software or other items provided to Service Provider in connection with the Materials.
6.3. Service Provider acknowledges that the Materials are experimental in nature and may have unknown characteristics and therefore agrees to use prudence and reasonable care in the use, handling, storage, transportation and disposition and containment of Materials. Service Provider agrees to conduct any studies utilizing the Materials under suitable containment conditions and in accordance with Applicable Laws.
6.4. Any and all unused Materials will promptly be returned to Pivot upon request.
6.5. The Materials are being made available in order to further research concerning them. THE MATERIALS BEING SUPPLIED UNDER THIS AGREEMENT ARE BEING SUPPLIED “AS IS”, WITH NO WARRANTIES, EXPRESS OR IMPLIED, AND PIVOT EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY. Pivot disclaims all representations that use of Materials by Service Provider will not infringe any patent or other proprietary right of any third party.
7.1. “Confidential Information” means any non-public, confidential and proprietary information, knowledge and know-how relating to Pivot and received by Service Provider in connection with this Agreement, including but not limited to the Materials and Pivot Background IP. Confidential Information also includes the terms, existence, and subject matter of this Agreement, Deliverables, Project Technology, and any other data, methods, results, conclusions, information made, conceived, reduced to practice or otherwise generated in connection with the Services, whether by Pivot or Service Provider and whether in written, oral, electronic, or digital form. Service Provider agrees to protect any and all Confidential Information and use Confidential Information solely for the performance of the Services with the exception of the following, which Service Provider can demonstrate by competent written proof: (a) information which is or (through no improper action or inaction by Service Provider or its employees) becomes generally known to the public; (b) information which was rightfully disclosed to Service Provider by a third party without restriction and with the legal right to disclose such information (including, without limitation, without any breach of the third party’s obligations to the disclosing Party); (c) information which was in Service Provider’s possession or known to Service Provider free of any confidentiality obligations prior to receipt from Pivot (or generation by Service Provider under this Agreement); or (d) information which was independently developed by employees of Service Provider without access to any other Confidential Information without obligations of confidentiality and not in the course of any performance hereunder.
7.2. Service Provider agrees (a) to hold the Confidential Information in confidence and to take all reasonable precautions to protect such information (including, without limitation, all precautions Service Provider employs with respect to its most confidential materials), (b) not to disclose, directly or indirectly, any Confidential Information to any third parties (except Authorized Representatives, subject to the conditions stated below), (c) not to use Confidential Information, except as expressly permitted under this Agreement, (d) not to file, under any circumstances, a patent application in any country in the world concerning the Confidential Information claiming any composition of matter, use, formulation, synthetic procedure, manufacturing procedure or method of administration without Pivot’s prior written consent, and (e) not to copy or reverse engineer any Confidential Information. Any Authorized Representative who is given access to Confidential Information must have a legitimate “need to know” and shall be similarly bound in writing. Service Provider shall be responsible (including under Section 10.1(c)) for any breach of this Section 7 made by an Authorized Representative as if Service Provider itself had committed such breach. Service Provider shall immediately notify Pivot in writing upon any unauthorized release or other breach of this Section 7 of which Service Provider is aware.
7.3. Service Provider may disclose Confidential Information to the extent required by law, government regulation or court order, provided that Service Provider will give Pivot at least thirty (30) days’ notice of such requirement (to the extent practicable and permitted by law, regulation or court order) so that Pivot may seek a protective order or take other reasonable action.
7.4. Except as required to perform Services, no license, implied or otherwise, is granted to Service Provider with respect to Deliverables, Materials, Project Technology, or Pivot’s Background IP.
7.5. Service Provider acknowledges that use, disclosure or distribution of Confidential Information contrary to the terms of this Agreement will cause irreparable harm for which damages at law will not be an adequate remedy and agrees that Pivot shall be entitled to seek immediate injunctive relief against Service Provider to enforce the confidentiality provisions of this Agreement, in addition to any and all other remedies available at law or in equity.
8. Intellectual Property.
a) Service Provider hereby irrevocably assigns to Pivot all right, title and interest in and to any Deliverables (including Samples) and information (including, without limitation, business plans and/or business information), technology, know-how, materials, notes, records, designs, ideas, inventions, improvements, devices, developments, discoveries, compositions, trade secrets, processes, methods and/or techniques, whether or not patentable or copyrightable, that are conceived, reduced to practice or made by Service Provider alone or jointly with others in the course of performing the Services (collectively, “Project Technology”).
b) Both Parties shall retain exclusive ownership of its Background IP. “Background IP” means all rights of a Party that is owned by the Party, controlled by the Party, or exclusively licensed by the Party in any of the following: (i) patent applications, patents, continuations, continuations in part, divisions, reissues, reexaminations, and derivatives thereof and their related foreign equivalents, (ii) copyrights, (iii) trade secrets, and (iv) know-how. Service Provider will not incorporate its Background IP or any invention, improvement, development, concept, discovery, work of authorship or other proprietary information owned by any third party into any Project Technology or Deliverable without Pivot’s prior written permission. Pivot Background IP includes the Materials and Pivot Confidential Information that is provided to Service Provider by and/or on behalf of Pivot and which was owned or controlled by Pivot prior to being provided to Service Provider and all intellectual property rights in and to any of the foregoing.
8.2. Assignments. Service Provider hereby makes any assignments necessary to accomplish the foregoing ownership provisions.
a) At Pivot’s reasonable request and expense, Service Provider agrees to assist Pivot in every proper way (including, without limitation, becoming a nominal party) to, evidence, record and perfect the assignment and to apply for and obtain recordation of and from time to time enforce, maintain, and defend Pivot’s proprietary rights in the Project Technology. As part of such assistance, Service Provider agrees to provide information regarding the source and collection of any Samples as reasonably requested by Pivot.
a) Except as otherwise provided herein, nothing in this Agreement is intended to grant to either Party any rights under any Intellectual Property right of the other Party with respect to Background IP.
9. Representations and Warranties Service Provider represents and warrants to Pivot that: (a) Service Provider has full power and authority to enter into and perform this Agreement; (b) neither Service Provider’s entering nor performing this Agreement will violate any right of or breach any obligation to any third party under any agreement between Service Provider and such third party; (c) the Services will be performed in a professional and workmanlike manner; (d) the Services and/or Deliverables shall not infringe the intellectual property rights of any third party; and (e) Service Provider has the right and unrestricted ability to assign the Deliverables to Pivot including, without limitation, the right to assign any Deliverables performed by any Authorized Representative.
10.1. Service Provider agrees to indemnify, defend and hold harmless Pivot, and its directors, officers and employees (collectively, “Pivot Indemnitees”) for any liability, demand, damage, cost or expense (including reasonable attorney’s fees) arising from any third-party claim, action or proceeding (“Claim”) to the extent shown by a court of competent jurisdiction to have arisen from: (a) the performance of the Services by Service Provider hereunder, (b) injuries to persons or damages which occur on Service Provider’s premises or premises under the exclusive control of Service Provider, (c) breach by Service Provider of this Agreement or its representations and warranties, or (d) the negligence or intentional misconduct of Service Provider or any of its employees, agents or representatives, except in each case, to the extent caused by the negligence or intentional misconduct of Pivot.
10.2. Except to the extent attributable to causes or events for which Service Provider is obligated to indemnify, defend and hold harmless under Section 10.1, Pivot agrees to indemnify, defend and hold harmless Service Provider, and its directors, officers, and employees (collectively, “Service Provider Indemnitees”) against any Claim to the extent shown by a court of competent jurisdiction to have arisen from: (a) Pivot’s breach of this Agreement or its representations and warranties, (b) the negligence or intentional misconduct of Pivot or any of its directors, officers, employees, agents or representatives, (c) infringement of any third party rights by Service Provider based on its use of Pivot’s Materials in accordance with the terms of this Agreement or the Statement of Work, except in each case, to the extent caused by the negligence or intentional misconduct of Service Provider.
10.3. Procedures. The indemnification obligations under this Section 10 are conditioned on the following: (a) the indemnified party must promptly notify the indemnifying party in writing of any Claim, provided, however, that the failure to so notify shall not relieve the indemnifying party of its indemnification obligations except to the extent it can show that it was materially prejudiced by such delay and then only to the extent of such prejudice), (b) the indemnifying party shall have sole control of the defense and/or settlement of the Claim; provided that the indemnified party shall have the right to participate with counsel of its own choosing in the defense and/or settlement of the Claim at its own expense, and, provided further, that the indemnifying party shall not settle a Claim in a manner that contains a stipulation to or admission or acknowledgement of liability or wrongdoing without the indemnified party’s prior written consent, and (c) only Service Provider may claim indemnity under this Section 10 on its own behalf or on behalf of a Service Provider Indemnitee and only Pivot may claim indemnity under this Section 10 on its own behalf or on behalf of a Pivot Indemnitee.
10.4. Insurance. During the Term, Service Provider agrees to carry insurance sufficient to cover its indemnification obligations hereunder with at least the following minimum requirements: (a) Commercial General Liability (including bodily injury and property damage liability, independent contractors liability, contractual liability, in an amount not less than $1,000,000 combined single limit, per occurrence, and $2,000,000 aggregate), (b) Workers’ Compensation (statutory limits required), and (c) Employers Liability Coverage ($500,000). Service Provider shall furnish proof of such insurance, including certificates, to Pivot at its request.
11.1. Independent Contractor Relationship. The Parties are independent contractors. Nothing contained herein shall be construed to place the Parties in the relationship of partners, principal and agent, employer/employee or joint venturer. Neither Party shall have power or right to bind or obligate the other, nor shall either hold itself out as having such authority.
11.2. Use of Name. Service Provider may not reference Pivot or use its trade names, trademarks or other proprietary designations in any advertising, publicity, or other promotional activities without Pivot’s express written consent.
11.3. Force Majeure. In the event either Party is delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor troubles, restrictive government or judicial orders, or decrees riots, insurrection, war, Acts of God, inclement weather or other similar reason or cause beyond such Party’s control, then performance of such act shall be excused for the period of such delay. Notice of the start and stop of any such force majeure shall be provided to the other Party. In the event that a Party’s performance is delayed due to force majeure for a period of more than ninety (90) days, the other Party may terminate this Agreement upon written notice to the affected Party.
11.4. Notices. Any notice shall be in writing and be deemed given on the date received if delivered personally or by email or, if sent by registered or certified U.S. mail, five (5) days after the date postmarked, return receipt requested, postage prepaid to the following address:
If to Service Provider:
To the address provided in the Statement of Work.
If to Pivot:
Attention: Legal Department
Pivot Bio, Inc.
2910 7th Street Berkeley, CA 94710
11.5. Governing Law. This Agreement shall be construed and enforced in accordance with the laws of the state of Delaware.
11.6. Mediation. The Parties agree to mediate any disputes arising out of or relating to this Agreement before commencing any action. No Party to this Agreement can proceed in court against the other Party without first participating in mediation, unless a Party refuses to submit to mediation and legal action is brought to specifically enforce this mandatory mediation provision of this Agreement. If the Parties cannot agree upon the person to act as the mediator within twenty (20) business days from notice of a request for mediation, then the American Arbitration Association will select a person to act as the mediator. The mediator’s charges and expenses will be split by the parties on a 50/50 basis. Each Party will be responsible for its own attorneys’ fees and costs at mediation. Any such mediation must be completed within sixty (60) days following appointment of the mediator. Should the dispute not be resolved by mediation, either party may request relief by a court of competent jurisdiction located in the county in the state where the Services are provided hereunder and the Parties waive any claim of forum non conveniens with regard to venue.
11.7. Severability. The invalidity or unenforceability of any paragraph or provision of this Agreement shall not affect the validity or enforceability of any one or more of the other paragraphs or provisions.
11.8. Waiver. Waiver or forbearance by either Party or the failure by either Party to claim a breach of any provision of this Agreement or exercise any right or remedy provided by this Agreement or Applicable Law, shall not be deemed to constitute a waiver with respect to any subsequent breach of any provision hereof.
11.9. Changes and Modification. No changes or modifications of this Agreement or any Statement of Work shall be deemed effective unless in writing and signed by the Parties.
11.10. Assignment. This Agreement may not be assigned by Service Provider without the prior written consent of Pivot. Pivot may assign this Agreement to a third-party entity provided that such entity agrees in writing to be bound by the terms and conditions of this Agreement. Any attempted assignment in violation of this Section 11.10 will be null and void.
11.11. Entire Agreement. This Agreement represents the complete and entire understanding between the Parties regarding the subject matter hereof and supersedes all prior negotiations, representations or agreements, either written or oral, regarding this subject matter.