Matters ▸ Attachment
2020.09.10 - Public Schools Free Testing Agmt (GBW Draft) template_HP — File 210862
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]