🏛 The Somerville Record
Matters ▸ Attachment

2020.09.10 - Public Schools Free Testing Agmt (GBW Draft) template_HP — File 210862

File 210862·7 pages·📄 Original PDF (city portal)·sha256 32171b0dc166…
Field Code Changed TESTING AGREEMENT This Testing Agreement (this “Agreement”), dated as of [__], 2020 (the “Effective Date”), is by and between [__], located at [__] (“School”) and Ginkgo Bioworks, Inc., a Delaware corporation, located at 27 Drydock Avenue, 8th Floor, Boston, MA 02210 (“Ginkgo”). Ginkgo and School may each be referred to individually in this Agreement as a “Party,” and jointly, as the “Parties.” Recitals A. Ginkgo offers a testing service for Coronavirus Disease 2019 (“COVID-19”) designed for schools and organizations to make available COVID-19 testing to their staff and communities (the “Testing Program”). Under the Testing Program, schools and organizations engage Ginkgo to arrange COVID-19 testing for their Staff, to be ordered through a web-based portal (the “Portal”) with the appropriate authorization from a healthcare provider. B. School desires for Ginkgo to make the Testing Program available to School, pursuant to which School’s staff, members and other personnel (collectively, “Staff”) will provide samples (“Samples”) to be tested for COVID-19 pursuant to an FDA-authorized test described on Schedule 1 to the Terms and Conditions (defined below) (the “COVID-19 Tests” or “COVID-19 Testing”), and Ginkgo desires to make the Testing Program available to School, including to arrange COVID- 19 Testing for School’s Staff. C. Ginkgo has identified School as a K-12 educational provider significantly impacted by the COVID- 19 pandemic and desires to donate the Testing Program to School free of charge as a public service in furtherance of School’s efforts to reopen safely and ensure the health and wellness of its Staff. THEREFORE, in consideration of the premises and the mutual promises set forth in this Agreement, and other good and valuable consideration, the exchange, receipt and sufficiency of which are acknowledged, the Parties agree as follows: I. Terms and Conditions. School acknowledges and agrees that all COVID-19 Testing conducted pursuant to this Agreement shall be subject to the terms and conditions attached hereto as Exhibit A and incorporated herein by reference (the “Terms and Conditions”) and that all Staff undergoing COVID-19 Testing hereunder is at least eighteen (18) years of age. II. Test Capacity Requested (the “Plan”). a. Testing Services. Ginkgo or its Laboratory (as defined in the Terms and Conditions) shall provide Sample collection kits and related materials (“Collection Kits”) to School CPT (Incoterms 2020) at the time(s) and location(s) identified below or otherwise agreed by the Parties, subject to Section 1.9 of the Terms and Conditions. b. Testing Schedule. Ginkgo shall provide [___] COVID-19 Tests for School on [______]. c. Testing Capacity. The daily maximum Capacity Allocation of COVID-19 Tests for School shall be [__]. d. Fees. Ginkgo will provide the COVID-19 Testing set forth above at no cost to School. Each Party shall otherwise be responsible for paying all costs of labor, supplies, materials, equipment, shipping, overhead and other expenses, direct and indirect, that are incurred by such Party in connection with this Agreement. Commented [HP1]: What is this? I don’t think it was defined above
Field Code Changed III. Testing Workflow; Responsibilities of School. The COVID-19 Testing service offered by Ginkgo comprises of 10 elements, components of which will be performed by School. Responsible Party School Ginkgo 1. Organization Sign-up ✓ 2. Test Scheduling / Setup ✓ 3. Staff Registration / Consents ✓ 4. COVID-19 Test Ordering / Healthcare Authorizations ✓ 5. Collection Kit Supply ✓ 6. Sample Collection (including coordination of return shipping) ✓ 7. Laboratory COVID-19 Testing ✓ 8. Results Reporting to Organization ✓ 9a. Results Reporting to Participating Staff ✓ 9b. Patient Results Consultations (for positive Test Results) ✓ 10. Positive Test Results Reporting to Public Health Authorities ✓ [Signature Page Follows]
IN WITNESS WHEREOF, the Parties hereto have executed this Agreement as of the Effective Date. GINKGO BIOWORKS, INC. SCHOOL By: By: Name: Reshma Shetty Name: Title: President Title: Notices shall be provided to the following addresses: If to Ginkgo: 27 Drydock Ave., Floor 8 Boston, MA 02210 Attention: General Counsel Email: [email removed] If to School: Attention: [________] Email: [________]
EXHIBIT A Terms and Conditions 1.0 Testing Program Activities. 1.1 Plan. Each Party will perform the activities and provide the material and information set forth in this Agreement, including the Plan. If any terms of the Plan conflict with the terms of this Exhibit A, the terms of this Exhibit A will govern unless the Plan expressly states that the terms of the Plan will govern with respect to a particular term. The Parties may amend any part of the Plan pursuant to an agreement set forth in writing (which may be approved by email). 1.2 Portal. The Testing Program will be administered through the Portal made available by a third party hosting provider. School and its Participating Staff will be required to agree to separate terms of service and a privacy policy (together, the “Portal Terms”) as a condition of using the Portal, and such use shall be subject to the Portal Terms in all respects. School agrees to comply (and agrees to cause Participating Staff to comply) with the Portal Terms when using the Portal. Notwithstanding anything to the contrary herein, Ginkgo shall not be liable for any problems, failures, defects or errors with the Portal to the extent caused by its hosting provider. 1.3 Staff; Informed Consent. School shall require each Staff member who participates in the Testing Program to register on the Portal and (a) execute, via the Portal, (i) an informed consent and (ii) an authorization for release of health information, each in the form provided by Ginkgo ((i) and (ii), an “Informed Consent”) and (b) agree to be bound by the Portal Terms (any Staff who completes (a) and (b), a “Participating Staff”). School shall not permit anyone other than Participating Staff who have executed an Informed Consent to participate in the Testing Program. Participating Staff shall access and use the Portal to (A) provide Informed Consent, (B) sign up for Sample collection and testing, (C) provide supporting information to a physician or other healthcare professional authorized to order COVID-19 Testing (“Ordering HCP”), to the extent such authorization is required by applicable state law, and (D) such other purposes set forth in this Agreement. All acts and omissions of Staff will be deemed to be those of School, and School shall be responsible therefor. School acknowledges and agrees that all decisions related to the order of COVID-19 Testing are required to be made by a healthcare provider and that Ginkgo has no role in such decision-making. 1.4 Testing Limitations. a) School acknowledges and agrees that, as of the Effective Date, the COVID-19 Tests provided hereunder are authorized under a U.S. Food and Drug Administration emergency use authorization (as described on Schedule 1) limiting testing of saliva specimens thereunder to patients with symptoms of COVID-19, and that all such COVID-19 Tests may only be performed pursuant to the order of a healthcare provider authorized under state law. b) As of the Effective Date, Ginkgo shall arrange for PWNHealth, LLC, or another entity contracted by Ginkgo, to provide Ordering HCPs to consult with Staff through the Portal in making decisions related to the order of COVID-19 Testing and to order such testing when deemed appropriate in the clinical judgment of the Ordering HCP. 1.5 Sample Collection Activities. a) Ginkgo or its Laboratory shall provide Collection Kits to School EXW (Incoterms 2020) on the date(s) and at the location(s) identified in the Plan or otherwise agreed by the Parties, subject to Sections 1.9-1.10 below. Collection Kits will be identified by a code in place of direct identifiers such that Ginkgo is not able to identify the Participating Staff who provided any Sample. School shall, and shall ensure that each Participating Staff, follows written instructions for use of the Collection Kit provided by Ginkgo or a third party contractor engaged by Ginkgo as a part of the Testing Program (a “Contractor”). b) School shall be solely responsible for distributing Collection Kits to Participating Staff and shall advise each Participating Staff to follow the instructions provided by Ginkgo concerning self-collection of Samples. School shall be responsible for the (i) registration of Collection Kits containing Samples and shipment of such Collection Kits to the Laboratory pursuant to the instructions provided by Ginkgo, (ii) distribution of Collection Kits to Participating Staff, and if applicable, any management, supervision or oversight of, or assistance with, such Sample collection, and (iii) any other activities related to the handling, storing, packaging, labeling or shipment of Collection Kits or Samples at a location (the “Sample Collection Activities”). School shall only provide Collection Kits to Participating Staff who have executed an Informed Consent. Ginkgo shall have no responsibility or liability (including for damages of any kind) with respect to any Sample Collection Activities performed. School shall, and shall ensure that its independent contractors, employees, agents, and each Participating Staff shall, follow the written instructions provided by Ginkgo for use of the Collection Kit provided by Ginkgo or Laboratory, and shall not include any information in connection with the Sample collection that would enable Ginkgo to identify any Participating Staff. 1.6 Treatment of Collection Kits and Samples. School shall be responsible for coordinating with Participating Staff and ensuring that School or each Participating Staff handles, stores and ships CPT (Incoterms 2020) to the Laboratory the Collection Kits and Samples in accordance with the Plan and written instructions provided by Ginkgo. School agrees that it shall not, and shall cause Participating Staff not to, use Collection Kits for any purpose except for the collection of Samples in accordance with this Agreement. Each Party shall be responsible and liable for the activities assigned to such Party pursuant to the terms of this Agreement relating to the handling, storing and shipment of Collection Kits and Samples. Ginkgo agrees that it will use the Samples only to perform the COVID-19 Testing and its other activities set forth in this Agreement. 1.7 Sample Analysis; Reporting of Test Results. Ginkgo shall arrange for COVID-19 Testing on the Samples collected from Participating Staff with an FDA-authorized test, which test will have the characteristics set forth on Schedule 1 (as amended from time to time). School acknowledges that the COVID-19 Testing shall be provided by a Contractor (such Contractor, the “Laboratory”) as set forth on Schedule 1. Ginkgo shall arrange for provision to School (as authorized in the Informed Consent) and Participating Staff (to the extent permitted by applicable law), in each case through the Portal, reporting as to whether the Participating Staff’s Sample tested positive or negative or, if the results cannot be determined, that the result is equivocal or inconclusive (“Test Results”). 1.8 Errors. Ginkgo shall not be required to (a) repair or replace any Collection Kit that is lost or damaged or (b) correct or re-perform any COVID-19 Testing, in each case, except in Ginkgo’s sole discretion. 1.9 Volume of Testing. a) Ginkgo agrees to perform up to the number of COVID-19 Tests identified in the Plan (such quantity, the “Aggregate Testing Volume”) for Participating Staff during the period(s) specified in the Plan, subject to the daily Capacity Allocation (as defined below). Such COVID-19 Testing shall be subject to any applicable timing, scheduling, location or other conditions or requirements of Ginkgo or Laboratory, and Ginkgo will have the right to adjust in its reasonable discretion the number of daily COVID-19 Tests to be delivered to or from a particular location on a particular date, including to account for scheduling or capacity constraints. b) The Parties agree that during the Term, the Laboratory shall have capacity to perform for School up to the maximum number COVID-19 Tests per business day set forth in the Plan (the “Capacity Allocation”). c) As used herein, to “perform” a COVID-19 Test or “performance” of a COVID-19 Test means that (a) Ginkgo provides a Collection Kit to School in accordance with the Plan, and (b) after School or Participating Staff ships such Collection Kits containing the Sample collected from such Participating Staff in accordance with Section 1.6, Laboratory conducts COVID-19 testing on such Sample and makes available the Test Results via the Portal in accordance with Section 1.7. 1.10 Unused Collection Kits. Ginkgo or Laboratory will ship to School sufficient quantities of Collection Kits to enable the COVID-19 Testing to occur in accordance with the Plan. Any unused Collection Kits provided to School shall remain the property of Ginkgo and shall be returned promptly upon Ginkgo’s request. 1.11 [Reserved] 1.12 HIPAA Inapplicable. The Parties acknowledge and agree that (i) Ginkgo is not a “Covered Entity”, as such term is defined in the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act and the regulations promulgated thereunder (collectively, “HIPAA”) and (ii) School is neither entering into this Agreement as a Commented [HP2]: This term again, but now the abbreviation has changed. Need to define what this is Formatted: Highlight
Covered Entity nor acting as a Business Associate (as defined in HIPAA) of Ginkgo via this Agreement, (iii) no contractor engaged by Ginkgo is acting on Ginkgo’s behalf as a Business Associate, and (iv) neither Ginkgo, nor School on Ginkgo’s behalf, shall submit any “standard transactions” (as defined in HIPAA) related to the COVID-19 Testing or other services provided hereunder. 1.13 No Incentive for Referrals; Non-Exclusive Provider. The Parties agree that Ginkgo is providing the COVID-19 Testing and services related thereto to School as a donation of goods and services. Ginkgo is providing such donation to assist School due to School’s financial need in light of the COVID-19 pandemic and the financial resources required to reopen safely, and does not provide such COVID-19 Testing and services in exchange for, as an inducement to, or in any way in consideration for, any explicit or implicit agreement for the generation of business between the Parties or in a manner that takes into account the volume or value of any referrals of clinical laboratory or other health care services between the Parties. School acknowledges and agrees that Ginkgo is not the sole provider of COVID-19 Tests in the Commonwealth of Massachusetts. School is free at any time to elect to receive COVID-19 Tests from another laboratory or other testing provider. A search tool provided by the Commonwealth of Massachusetts that can be used to locate laboratories that may have the capacity and ability to provide such testing as of the Effective Date is available at the following website link under the heading “Testing options for Entities”: https://www.mass.gov/info-details/covid-19-testing-guidance (each such laboratory, an “Alternate Laboratory”). Ginkgo makes no representation or warranty as to the capacity, ability to conduct testing on any Samples, qualification of personnel, or clinical laboratory certification of any Alternate Laboratories, or the costs that any such Alternate Laboratory may impose on School or Participating Staff for testing the Participating Staff’s Sample, or the purposes for which any such Alternate Laboratory may use a Participating Staff’s Sample or Test Results or any such Alternate Laboratory’s privacy practices. 2.0 Use of Results. 2.1 Test Results; Ginkgo Data. As between the Parties, (i) the Test Results will be deemed the Confidential Information of School and (ii) the Ginkgo Data (as defined below) will be deemed the Confidential Information of Ginkgo, and in each case, subject to the obligations of confidentiality set forth in Article 5.0. As used herein, “Ginkgo Data” means (a) all operational data and information observed, collected or generated under the Plan or this Agreement, (b) any survey results or Feedback provided to Ginkgo, (c) all other observations, data and residuals of or from Ginkgo (or its Contractors if applicable) performing the Plan or this Agreement (including uses set forth in the Informed Consent), and (d) any aggregate, de-identified data from the Testing Program; provided that, the Ginkgo Data shall not include the individualized Test Results. 2.2 Ginkgo Use of Test Results. Notwithstanding Section 2.1 above, Ginkgo and its contractors shall be permitted to use and disclose the Test Results (i) as reasonably necessary to perform its activities under this Agreement (including reporting the Test Results to School or the applicable Participating Staff), (ii) as reasonably necessary to research, develop, test or improve the Testing Program or any other Ginkgo or contractor technologies, foundries, databases or platforms, including publications thereof, (iii) to the extent required under applicable law, or (iv) to aid any governmental authority (including without limitation any federal, state or local public health agency, the U.S. Department of Health and Human Services or the Centers for Disease Control and Prevention) or its contractors or representatives in connection with its COVID-19 response. 2.3 Ginkgo Use of Ginkgo Data. Ginkgo may freely use and exploit in any manner the Ginkgo Data, including for the purposes set forth in Section 2.2 above. 3.0 Payments. Ginkgo is providing the COVID-19 Testing to School as an in-kind donation of services and supplies. School shall have no payment obligation for the COVID-19 Testing and other services to be rendered by Ginkgo hereunder. Each Party shall otherwise be responsible for paying all costs of labor, supplies, materials, equipment, shipping, overhead and other expenses, direct and indirect, that are incurred by such Party in connection with this Agreement. The Parties acknowledge that the fair market value of the COVID-19 Testing, including the Collection Kits, is between $85-$150 (per test? Per kit?) depending on the services provided by Ginkgo and its Contractors in connection with the COVID-19 Testing. 4.0 Term and Termination. 4.1 The term of this Agreement will commence on the Effective Date and, unless earlier terminated in accordance with this Article 4.0, will remain in effect for a period of two (2) months (the “Term”), unless extended by mutual written agreement. 4.2 Ginkgo may terminate this Agreement for convenience upon seven (7) days’ prior written notice to School. Either Party may terminate this Agreement on thirty (30) days’ prior written notice to the other Party if the other Party materially breaches this Agreement and does not cure such breach within thirty (30) days after written notice thereof. The Parties may terminate this Agreement in its entirety by mutual consent through a writing executed by a duly authorized representative of each Party and shall discuss in good faith the consequences of such termination. 4.3 In the event that Ginkgo is unable to supply the Collection Kits or that the cost of supplying the Collection Kits increases substantially due to an order of a governmental agency, governmental commandeering of necessary supplies or equipment, or other severe unanticipated changes in supply chains for necessary supplies or equipment, this Agreement shall be terminated upon the delivery of a written notice from Ginkgo to School. 4.4 Articles 2.0, 5.0, 6.0, 7.0, 8.0, 9.0 and 10.0, and this Section 4.4 will survive expiration or termination of this Agreement. 5.0 Confidentiality. 5.1 Subject to the limitations set forth in Section 5.2, “Confidential Information” means any non-public information provided by one Party or its affiliates or subcontractors to the other Party under this Agreement. 5.2 Confidential Information will not be deemed to include information that: (a) is in the public domain or comes into the public domain through no fault of the recipient Party; (b) is furnished to recipient Party without any obligation of confidentiality by a third party rightfully in possession of such information; (c) is already known by the recipient Party at the time of receiving such information from discloser Party as evidenced by recipient Party’s written records; or (d) is independently developed by the recipient Party without reference to or use of Confidential Information of discloser Party. 5.3 Except as expressly allowed herein, the recipient Party agrees (a) to hold discloser Party’s Confidential Information in confidence and to take all reasonable precautions to protect discloser Party’s Confidential Information, (b) not disclose discloser Party’s Confidential Information to third parties, and (c) not to use discloser Party’s Confidential Information other than to perform its obligations or exercise its rights pursuant to the terms of this Agreement. 5.4 Notwithstanding the foregoing, the recipient Party may use and/or disclose Confidential Information of the discloser Party in the following instances: (a) to prosecute or defend litigation, to respond to inquiries from a court or governmental agency or as otherwise required by law; provided, however, that the recipient Party shall notify the discloser Party promptly upon receipt thereof, giving (where practicable) the discloser Party sufficient advance notice to permit it to oppose, limit or seek confidential treatment for such disclosure; (b) to comply with applicable laws, rules, regulations and guidance of a securities agency, commission, regulatory body or exchange, if in the reasonable opinion of the recipient Party’s counsel, such disclosure is necessary for such compliance; and (c) to disclose, in connection with the performance of this Agreement, to affiliates; Contractors; permitted subcontractors; or their respective employees, directors, consultants or agents, or their respective professional advisors, each of whom prior to disclosure must be bound by obligations of confidentiality consistent with the obligations set forth in this Article 5.0. If any Confidential Information is disclosed in accordance with this Section 5.4, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such permitted disclosure results in a public disclosure of such information (other than by breach of this Agreement). 5.5 Ginkgo may use and include the name and logo of School, and reference and provide a summary of this Agreement (which shall not include any Confidential Information of School) in its marketing materials. 5.6 Notwithstanding the above or anything to the contrary herein, to the extent that School at any time provides Ginkgo with any feedback or suggestions regarding the Testing Program or Ginkgo’s activities under this Agreement, including potential improvements or changes thereto (collectively, “Feedback”), the Feedback shall not be considered Confidential Information of School, and Ginkgo shall be free to use, disclose and otherwise exploit in any manner, the Feedback for any purpose and without compensation to School. 5.7 The Parties each stipulate and agree that (a) the other Party’s Confidential Information includes highly sensitive trade secret information, (b) a breach of this Article 5.0 will cause irrevocable harm for which monetary damages would not provide a sufficient remedy, and (c) in such case of an actual or threatened breach of this Article 5.0, in addition to any other remedy available under this Agreement or under applicable laws or equity, the non-breaching Party shall be entitled to seek and obtain equitable relief (including temporary or permanent restraining orders, specific performance or other injunctive relief) from any court of competent jurisdiction, without the necessity of posting any bond or of any undertaking, and without any requirement to submit to any dispute resolution procedures contained herein. 6.0 Intellectual Property. 6.1 Each Party shall expressly retain all rights, title and interests in and to all intellectual property and other technology of such Party, including any intellectual property invented or reduced to practice by such Party prior to or independently of the performance of this Agreement. Ginkgo shall solely own all rights, title and interests in and to the (a) the Ginkgo Data, (b) all material and technology used or generated by Ginkgo in performance of its obligations or other activities under this Agreement, other than the Samples (and any material accompanying the Samples provided by Commented [HP3]: De-identified? Commented [HP4]: Just pointing out, this is fairly short notice and could be disruptive to school operations. We may want to see if there is any flexibility on this timeframe
School or a Participating Staff to Ginkgo), and (c) the Testing Program (including any modifications, improvements or derivatives thereto) (collectively, “Ginkgo IP”); and all intellectual property rights in and to the foregoing. To the extent School owns any Ginkgo IP, it hereby assigns and agrees to assign to Ginkgo all of its rights, title and interests in, to and under such Ginkgo IP. School shall take all further actions and execute all documents reasonably requested by Ginkgo, at Ginkgo’s cost and expense, to effect and perfect such assignments. Ginkgo shall be solely responsible for the prosecution of all Ginkgo IP owned by or assigned to it hereunder. 6.2 No right or license in, to or under any intellectual property or other proprietary rights of either Party is granted, conveyed or transferred or shall be deemed granted, conveyed or transferred by implication or estoppel. 7.0 Representations, Warranties and Covenants of School. 7.1 School represents, warrants and covenants that: (a) School shall comply with all laws, rules, regulations, guidances and orders applicable to (i) its exercise of rights and performance of obligations and other activities under this Agreement and (ii) its actions or decisions made based on the Test Results, including in each case applicable employment, education and privacy laws; (b) before shipping a Sample, School will ensure that the applicable Staff executed the Informed Consent and all other required forms through the Portal; (c) School will not bill or charge, or seek reimbursement from, any third party payor (including any government program, insurer or Medicare, Medicaid or other health plan) for or in connection with the COVID-19 Testing or any services rendered or other activities conducted by either Party under this Agreement; and (d) School will consult with its own legal counsel prior to obtaining any information from Staff and making any decisions or determinations (including with respect to return to work, return to school, or any enrollment, membership, employment, education or personnel matters) based on the Test Results. 7.2 As between the Parties, School is solely responsible for its own legal compliance matters, including any decisions relating to enrollment, employment, education or personnel matters. 8.0 Disclaimers; Limitation of Liability. 8.1 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, THE TESTING PROGRAM, THE COVID-19 TESTING AND THE TEST RESULTS ARE PROVIDED “AS-IS”. GINKGO HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THE TESTING PROGRAM, THE COVID-19 TESTING AND THE TEST RESULTS, WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL, STATUTORY OR OTHERWISE, INCLUDING ANY WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR USE, NON-INFRINGEMENT OF ANY THIRD PARTY RIGHTS, AND ANY WARRANTY ARISING THROUGH COURSE OF PERFORMANCE OR USAGE OF TRADE. 8.2 IN NO EVENT WILL GINKGO BE LIABLE TO SCHOOL OR ANY STAFF, REGARDLESS OF THE FORM OF ACTION, INCLUDING CONTRACT, INDEMNITY, WARRANTY, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY OR OTHERWISE, FOR ANY DIRECT, INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (WHICH MAY INCLUDE LOST PROFITS, REVENUE OR BUSINESS) ARISING UNDER OR RELATED TO THIS AGREEMENT, THE TESTING PROGRAM, THE COVID-19 TESTING, THE TEST RESULTS OR USE THEREOF, OR THE GINKGO DATA, EVEN IF GINKGO HAS BEEN ADVISED OF OR COULD HAVE REASONABLY FORESEEN THE POSSIBILITY OF SUCH DAMAGES. 8.3 NOTWITHSTANDING ANYTHING TO THE CONTRARY HEREIN, THE PARTIES AGREE AND ACKNOWLEDGE THAT THEY INTEND FOR THE COVID-19 TESTS DESCRIBED HEREIN TO BE “COVERED COUNTERMEASURES” AND FOR GINKGO TO BE A “COVERED PERSON,” AS BOTH TERMS ARE DEFINED WITHIN THE PUBLIC READINESS AND EMERGENCY PREPAREDNESS (“PREP”) ACT, 42 U.S.C. 247D-6D, AND INTEND FOR THE SERVICES TO BE PERFORMED HEREUNDER BY GINKGO TO BE ACTIVITIES AUTHORIZED IN ACCORDANCE WITH THE PUBLIC HEALTH AND MEDICAL RESPONSE OF THE AUTHORITY HAVING JURISDICTION (WITHIN THE MEANING OF THE PREP ACT) TO PRESCRIBE, ADMINISTER, DELIVER, DISTRIBUTE OR DISPENSE THE COVERED COUNTERMEASURES. SCHOOL SHALL OBTAIN AND DELIVER TO GINKGO A LETTER FROM THE SCHOOL SHALL OBTAIN AND DELIVER TO GINKGO A LETTER FROM THE BOARD OF DIRECTORS OF ITS GOVERNING SCHOOL DISTRICT STATING THAT THE COVID-19 TESTING SERVICES PROVIDED HEREUNDER ARE AUTHORIZED IN ACCORDANCE WITH THE RESPONSE OF THE SCHOOL DISTRICT TO THE COVID-19 PANDEMIC WITHIN 30 DAYS OF THE EFFECTIVE DATE. 9.0 Indemnification. 9.1 School shall be solely responsible for any and all losses, claims, damages, costs and expenses of any kind or nature arising out of or relating in any way to School’s use of the COVID-19 Testing or Testing Program (“Claims”), and Ginkgo shall not have any liability with respect to any of the foregoing. 9.2 School shall not take any action to settle or defend any Claim that would in any manner impose obligations (monetary or otherwise) on Ginkgo without Ginkgo’s written consent, not to be unreasonably withheld. In connection with any such Claim, Ginkgo may, at its own expense, have its own counsel in attendance at all public interactions and substantive negotiations at its own cost and expense. 10.0 Miscellaneous. The Parties hereto are independent contractors and not in the relationship of partners, principal and agent, employer/employee or joint venturer. Neither Party will have power or right to bind or obligate the other, nor will either hold itself out as having such authority. Any notice required or permitted to be given hereunder by either Party will be in writing and will be deemed given on the date received if delivered personally or by email, and in any event, with a copy delivered by email, to the address set forth in the preamble and the signature page. This Agreement and the rights and obligations of the Parties hereunder will be governed by the laws of the Commonwealth of Massachusetts without regard to the conflict of laws provisions thereof. The Parties agree that any dispute regarding the interpretation or validity of this Agreement will be subject to the exclusive jurisdiction of the state and federal courts in and for the Commonwealth of Massachusetts, and each Party hereby agrees to submit to the personal and exclusive jurisdiction and venue of such courts. If any one or more provisions of this Agreement is found to be illegal or unenforceable in any respect, the remaining provisions will not in any way be affected or impaired thereby; provided, however, that the surviving agreement materially comports with the Parties’ original intent. Waiver 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 will not be deemed to constitute a waiver with respect to any subsequent breach or exercise of any provision or right hereof. No changes or modifications to this Agreement (including the Plan) will be deemed effective unless in writing and executed by the Parties hereto. This Agreement may not be assigned by Ginkgo or School without the prior written consent of the other, such consent not to be unreasonably withheld, except that Ginkgo may assign this Agreement in connection with a sale or merger of all or substantially all of the assets to which this Agreement pertains. For avoidance of doubt, Ginkgo may delegate or subcontract any or all of its obligations under this Agreement to one or more of its affiliates or third parties. Neither Party shall be charged with any liability for delay or failure in performance of an obligation under this Agreement to the extent such delay or failure is due to a cause beyond the reasonable control of the affected Party, such as war, riots, labor disturbances, fire, explosion, supply shortages, disruptions in essential commodities, utilities, transportation, services (including those of third parties or subcontractors), software, websites, applications or infrastructure, internet outages, acts of government (including (a) those of a nature described in Section 4.3 or (b) (i) the failure to renew any executive orders waiving or (ii) changes to, in either case, certain legal or regulatory requirements that, if in effect, would prevent performance of the services hereunder), or actions or inactions taken to comply (in the reasonable discretion of a Party) with any governmental law, regulation, guidance or order. The Party affected shall promptly inform the other Party in writing of any material delay or failure to perform due to such causes. 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. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. The Parties acknowledge and agree that the exchange of electronic signatures shall have the same legal validity as the Parties’ signatures would have if signed in hard-copy form.
Schedule 1 Test Information • The Rutgers Test has not been FDA cleared or approved. • The Rutgers Test has been authorized by the FDA under an EUA for use by Rutgers. • The Rutgers Test has been authorized only for the detection of nucleic acid from SARS- CoV-2, not for any other viruses or pathogens. • The Rutgers Test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. [See attached Rutgers EUA]