CONFIDENTIAL
IVD TEST KIT AGREEMENT – NOVASEQDXThis IVD Test Kit Agreement (this “Agreement”) is effective as of the Effective Date and is madeby and between Illumina, Inc. (“Illumina”) and ______________________ (“Developer”). Illumina andDeveloper may be referred to each individually as a “Party” and collectively as the “Parties.”
WHEREAS, Developer desires to Develop and Commercialize up to three in vitro diagnostic test
kits for use on Illumina’s expected NovaSeqDx sequencing instrument. These test kits will: (a) include
target enrichment and library preparation components and off‐instrument software Developed by
Developer; and (b) use nucleic acid core sequencing consumables and on‐instrument software
provided by Illumina; andNOW, THEREFORE, in consideration of the mutual covenants contained in this Agreement, theforegoing recitals, and other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties agree as follows:
1.

DEFINITIONS

The following capitalized terms will have the following meanings:
1.1“Acceptance Period” is defined in Section 2.4(a).

1.2 “Advisors” means, with respect to a Party, its and its Affiliates’ attorneys, accountants,
financial advisors, and other similar professional advisors.
1.3 “Affiliate” means, with respect to any Person, any other Person that, directly or indirectly,
through one or more intermediaries controls, is controlled by, or is under common control with, suchfirst Person for so long as such other Person controls, is controlled by, or is under common control withsuch first Person. For purposes of this definition “control” means the possession, direct or indirect, ofthe power to direct or cause the direction of the management of a Person, whether through ownershipinterests, by contract, or otherwise. Without limiting the generality of the foregoing, a Person will bedeemed to control any other Person in which it owns, directly or indirectly, more than 50% of theoutstanding shares, stock, securities or other ownership interests of such Person.
1.4 “Business Day” means all days other than Saturdays, Sundays, or a national holiday
recognized in the United States.
1.5 “Change Period” means the period of time beginning on the date the IVD Hardware receives
Regulatory Approval in the United States and ending on the date ten years after the GRAIL Closing
Date. Illumina will ensure that all parties who have entered into similar agreements with Illumina todevelop distributable in vitro diagnostic test kits for use with the IVD Hardware in the Field have thesame Change Period for the IVD Hardware, including any extensions to the Change Period Illumina may
make from time to time.

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1.6“Claims” is defined in Section 9.1.

1.7 “Commercialization” (and its corollaries) means those activities directed to the selling,
marketing, and promotion of a product, including manufacturing, marketing, promoting, transporting,
distributing, selling, and supporting of such product.
1.8 “Control” or “Controlled” means, with respect to any IP, possession of the right, whether
directly or indirectly, and whether by ownership, license, or otherwise, to grant access, a license or
sublicense, or other right to or under such IP as provided for herein, without obtaining the consent of
any Third Party, violating the terms of any written agreement with any Third Party, or incurring any
financial or other material obligation to any Third Party. Notwithstanding the foregoing, if a Party is
acquired by a Third Party, whether by merger, acquisition, sale of assets, or otherwise, in no event will
any IP rights of such Third Party or its Affiliates be deemed Controlled by the acquired Party orotherwise be deemed part of the acquired Party’s Background IP.
1.9“Converter Software” means BCL to FASTQ conversion software or any future similarsoftware generally made commercially available by Illumina that converts IVD Hardware data output toa different format for subsequent analysis.
1.10 “Confidential Information” means all information and know‐how and any tangible
embodiments thereof provided by or on behalf of the Disclosing Party or its Affiliates to the Receiving
Party or its Affiliates in the course of performing under this Agreement, whether disclosed in writing,verbally, or otherwise, that is identified or marked as “Confidential” (or with similar language) orshould reasonably be ascertained to be confidential, either because of the circumstances of disclosureor the nature of the information itself. Confidential Information may include data, knowledge,
practices, processes, ideas, research plans, formulations, manufacturing techniques, marketing andbusiness plans, financial information, personnel information, and other information relating to theDisclosing Party or its Affiliates or to its or its Affiliates’ present or future products, sales, suppliers,
customers, employees, or business; provided however that Confidential Information specifically
excludes any information that:(a)at the time of disclosure is generally available to the public;(b) after disclosure becomes generally available to the public by publication or otherwise
through no fault of the Receiving Party or its Representatives or Advisors;(c)the Receiving Party can demonstrate was in its possession or in the possession of its
Representatives before disclosure by the Disclosing Party and which was not acquired, directly or
indirectly, from the Disclosing Party or its Representatives, and which is held by the Receiving Party
free of any obligation of confidence to any Third Party;(d) the Receiving Party can demonstrate was received by it after the time of disclosure
by the Disclosing Party from a Third Party who had a lawful right to disclose it to the Receiving Party
and who did not require the Receiving Party to hold it in confidence; or‐2‐

CONFIDENTIAL(e)the Receiving Party can demonstrate was generated by or for the Receiving Party or
its Representatives without any use of or reference to the Disclosing Party’s Confidential Informationor violation of this Agreement, as evidenced by contemporaneous written records;
in each case, even if such information is specifically designated as Confidential Information in thisAgreement.
1.11 “Customer” means an end‐user purchaser of an IVD Test Kit.
1.12 “Developer Analysis Software” means off‐instrument analysis, interpretation, and reporting
software Developed and Commercialized by Developer or its Affiliates that will accept standard
sequencing output files generated by the IVD Hardware (as converted by Converter Software if
specified in the IVD Plan).
1.13“Developer Indemnitees” is defined in Section 9.2.

1.14 “Development” (and its corollaries) means those activities directed to the development of a
product, including research, development, verification, qualification, and validation. With respect toan IVD Test Kit, “Development” also includes all activities relating to seeking, obtaining, andmaintaining Regulatory Approval.
1.15 “Disclosing Party” means a Party who discloses (or whose Representative or Advisor
discloses) its Confidential Information to the other Party.
1.16 “Dispute” is defined in Section 13.1.
1.17 “Distributor” means a Third Party authorized by Developer to purchase IVD Test Kits from
Developer or its Affiliate and re‐sell those IVD Test Kits to Customers.
1.18 “Effective Date” means (a) the GRAIL Closing Date if this Agreement is signed before the
GRAIL Closing Date, or (b) the date of last signature below if this Agreement is signed after the GRAIL
Closing Date. This Agreement will not be effective unless and until the GRAIL Transaction closes,
regardless of the date of signing.
1.19 “EMA” means the European Medicines Agency, or any successor thereto.
1.20 “FDA” means the United States Food and Drug Administration, or any successor thereto.
1.21 “Field” means genetic testing of human samples in the field of oncology, including risk
assessment, predisposition, screening, diagnosis, staging, prognosis, prediction, monitoring, andtreatment selection; provided, however, that the Field does not include: (a) WGS Assays; (b) forensic
testing; (c) non‐invasive prenatal testing; (d) pre‐implantation genetic screening of embryos or pre‐implantation genetic diagnosis of embryos; or (e) human leukocyte antigen testing in connection with‐3‐

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transplantation. As used above, “forensic testing” specifically includes without limitation all testing for(i) legal evidence analysis, (ii) mass disaster, missing persons and unidentified human remains
identifications, (iii) parentage determination, (iv) kinship analysis (including for twins), (v) forensic
phenotyping, (vi) generation of leads in an investigation, including intelligence and data collection
regarding suspected possession, transfer and use of bioweapons in response to a specific bioterror
threat or tip, (vii) body fluid, tissue identification, and epigenetic analyses for crime context
information, and (viii) investigation of criminal acts using microbes, human metagenomics signatures atcrime scenes, including acts of bioterror and biowarfare, traces of human movement via nonhumanDNA, estimation of postmortem interval (PMI, necrobiome), molecular autopsy, or sudden deathinvestigation. As used above, “non‐invasive prenatal testing” specifically includes without limitation all
testing of nucleic acids of fetal or placental origin present in maternal tissue (including maternal bloodand blood components).
1.22 “Force Majeure” means any cause beyond such Party’s reasonable control and without its
fault or negligence, which for example may include fire, flood, tornado, earthquake, hurricane,lightning, pandemic, actual or threatened acts of war, terrorism, civil disturbance or insurrection,
sabotage, embargo, acts of government (including injunctions), labor shortages or disputes, material or
equipment shortages, transportation difficulties, and interruption or failure of any utility service orequipment.
1.23 “GAAP” means generally accepted accounting principles in the United States at the time inquestion.
1.24 “GRAIL Closing Date” means the closing date of Illumina’s proposed acquisition of GRAIL,
Inc. pursuant to the Agreement and Plan of Merger, dated September 20, 2020 (as amended on
February 4, 2021 by the Amendment to the Agreement and Plan of Merger), among Illumina, Grail,
SDG Ops, Inc., a Delaware corporation and direct, wholly owned subsidiary of Illumina, and SDG Ops,
LLC, a Delaware limited liability company and direct, wholly owned subsidiary of Illumina (the “GRAILTransaction”).
1.25 “Illumina Core IP” means the IP Controlled by Illumina as of the date the IVD Hardware or
Sequencing Consumable ships to Developer, that pertains to or covers aspects or features of the IVD
Hardware or Sequencing Consumable (or use thereof) that are common to the IVD Hardware or
Sequencing Consumable in all applications and all fields of use, but does not include IP that pertains toor covers aspects or features of the IVD Hardware or Sequencing Consumable (or use thereof) onlywith regard to specific field(s) or specific application(s).
1.26“Illumina Indemnitees” is defined in Section 9.1.

1.27 “IP” means all rights in patent, copyrights (including rights in computer software), trade
secrets, know‐how, trademark, service mark and trade dress rights and other industrial or intellectual
property rights under the laws of any jurisdiction, whether registered or not and including all
applications therefor and registrations thereto.

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1.28“IVD Hardware” means Illumina’s expected NovaSeqDx diagnostic sequencing instrument.

1.29 “IVD Plan” means, with respect to each IVD Test Kit, the written plan agreed upon by theParties describing the activities to be undertaken by the Parties to enable Developer to Develop such
IVD Test Kit in accordance with this Agreement. Each IVD Plan will include at least: (a) the compositionand configuration of the subject IVD Test Kit and the Sequencing Consumables and IVD Hardware to be
used in the subject IVD System; (b) the planned activities and timelines for the Development of the IVD
Test Kit and IVD System (including the LRM Software Module) to the extent involving or impacting
Illumina; (c) the intended use statement for the IVD Test Kit; and (d) any Illumina consulting activities
or obligations. Each IVD Test Kit will be described in an IVD Plan. Each reference to “the IVD Plan” inthis Agreement refers to the applicable IVD Plan relating to the subject IVD Test Kit.
1.30 “IVD System” means a complete in vitro diagnostic system consisting of: (a) IVD Hardware;(b) Sequencing Consumables; (c) the LRM Software Module; (d) an IVD Test Kit; and (e) any Other IVD
System Components as may be specified in the applicable IVD Plan. Each IVD System will be describedin more detail in the applicable IVD Plan.
1.31 “IVD Test Kit” means a kitted nucleic acid sequencing assay Developed by Developer as thelegal manufacturer under this Agreement for (and receiving Regulatory Approval for) in vitro diagnostic
use with IVD Hardware, Sequencing Consumables, and an LRM Software Module in an IVD System in
the Territory in the Field, consisting generally of assay‐specific target enrichment and library
preparation components (including panel specific primers), assay‐specific run controls, and Developer
Analysis Software. Each IVD Test Kit will be described in the applicable IVD Plan. As context requires,“IVD Test Kits” or “an IVD Test Kit” refers to specific unit(s) of an IVD Test Kit. For clarity, (a) each IVD
Test Kit is specific to a particular IVD Hardware (and related Sequencing Consumables) and a particular
LRM Software Module; if an assay is for use with more than one IVD Hardware (and related Sequencing
Consumables) or LRM Software Module, each such version is a unique IVD Test Kit; and (b) if multiple
versions of an assay are or would be the subject of separate PMAs or 510(k)s under U.S. law(regardless of the jurisdiction(s) where Regulatory Approvals are actually sought), then each suchversion is a unique IVD Test Kit; and (c) subject to (a), if two assays are or would be the subject of thesame PMA or 510(k), such that the second assay only requires or would require a supplemental filingwith the FDA (regardless of the jurisdiction(s) where Regulatory Approvals are actually sought), the two
assays will be deemed to be part of the same IVD Test Kit. If any modification to the LRM Software
Module is required, Developer will pay Illumina on a time‐and‐materials basis for any necessary
revisions to such LRM Software Module.
1.32 “Law” means: (a) all statutes, regulations, ordinances, and directives and applicable policies,
rules, or orders made or given by a governmental authority or Regulatory Authority that, in each case,are binding on a Party as a matter of law; (b) common law and the law of equity as applicable to a
Party; (c) court orders, judgments, or decrees that are binding upon a Party; and (d) industry codes ofpractice, policies, or standards in each case to the extent enforceable against a Party by agovernmental authority or Regulatory Authority as law.
1.33

“Losses” is defined in Section 9.1.
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1.34 “LRM Software Module” means a test execution software module that enables an IVD Test
Kit to be executed on the IVD Hardware, together with Converter Software if necessary and specified in
the IVD Plan, whether or not the Converter Software is part of the LRM Software Module or separate.
For Illumina’s existing NextSeq 550Dx diagnostic sequencing instrument, the LRM Software Module is,
as of the Effective Date, an on‐IVD Hardware local run manager software module, but the Parties
acknowledge that the NovaSeqDx may use different software to accomplish similar functionality, whichsoftware will constitute the LRM Software Module for the NovaSeqDx.
1.35 “MHRA” means the Medicines and Healthcare Products Regulatory Agency, or any
successor thereto.
1.36“Milestone Payments” is defined in Section 5.1.

1.37 “Net Sales” means, with respect to an IVD Test Kit, the gross amount charged (in any
manner) by or on behalf of Developer or its Affiliates for the arm’s length sale, transfer, or otherdisposition of an IVD Test Kit to a Customer or Distributor (as further specified below) less thefollowing items to the extent reasonable and actually paid, taken, or incurred with respect to such sale,transfer, or other disposition, all in accordance with standard allocation procedures, allowancemethodologies, and accounting methods consistently applied, in accordance with GAAP (except asotherwise provided below):(a)credits or allowances for returns, rejections, recalls, or billing corrections;(b) separately itemized freight, postage, shipping, handling, and insurance, and othertransportation and importation costs;(c) separately itemized sales, use, value added, medical device excise, and other similartaxes (excluding income taxes), tariffs, customs duties, surcharges and other governmental charges
levied on the production, sale, transportation, delivery or use of the IVD Test Kit in the Territory thatare incurred at time of sale or are directly related to the sale and are actually paid; and(d) any quantity, cash, or other trade discounts, rebates, refunds, or charge backs.
No deductions may be made for sales commissions (or similar payments) or collection costs.
Developer’s sale, transfer, or other disposition of an IVD Test Kit to an Affiliate, or the sale, transfer, orother disposition between Affiliates, will not be included in Net Sales unless such sale, transfer, orother disposition is to an Affiliate end‐user for the performance of a Subject Test (in which case Net
Sales for such Subject Test will be determined as follows). If Developer or its Affiliate uses an IVD Test
Kit to perform a Subject Test, such use will be deemed a sale of the IVD Test Kit and Net Sales fromsuch sale will equal the average Net Sales from the arm’s length sale of the IVD Test Kit used in theperformance of such Subject Test in the country from which the tested sample originated during thesame Reporting Period, or if there is no such average value, the average Net Sales from the arm’s
length sale of the IVD Test Kit in similar markets (or if there are no similar markets, in all markets)‐6‐

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during the same Reporting Period. For the avoidance of doubt, the gross amount charged by Affiliates
to Customers or Distributors for sale, transfer, or other disposition of an IVD Test Kit is included in Net
Sales.
If Developer or its Affiliate directly or indirectly charges any amount to a Distributor or Customer foraccess to an LRM Software Module of any kind (in excess of what is charged for the IVD Test Kit andalready included in Net Sales), such amount will be included in the Net Sales for the related IVD Test
Kit.
In the event that any IVD Test Kit is sold, transferred, or otherwise disposed of in combination with one
or more products which are themselves not an IVD Test Kit (or component thereof) (“Other Products”),
for a single price (a “Combination Product”), the Net Sales for such IVD Test Kit will be calculated bymultiplying the sales price of such Combination Product by the fraction A/(A+B) where A is thestandard published list price of the IVD Test Kit and B is the standard published list price of the Other
Products, in each case in the country where the Combination Product was sold, transferred, orotherwise disposed of. If a standard published list price for either the IVD Test Kit or the Other
Products is not available, Developer will notify Illumina at least 60 days before the launch of the IVD
Test Kit in the applicable country and the Parties will in good faith negotiate an appropriate andreasonable fair market value to represent list price.
If an IVD Test Kit is sold, transferred, or otherwise disposed of in a manner that is not an arm’s‐lengthtransaction (including without limitation, transactions with related parties, transactions made underduress or threat of litigation, transactions made for no consideration, and transactions made pursuant
to a collaboration, joint venture, or similar relationship), or for non‐monetary consideration, then Net
Sales for such transaction will equal the average Net Sales from the arm’s length sale of such IVD Test
Kit in the same country during the same Reporting Period.
If, in any case, (x) there is not sufficient information available to reasonably determine Net Sales, (y)Developer employs a method or structure for Commercializing the IVD Test Kits that does notreasonably fit the above calculations or does not result in a reasonable Net Sales calculation, or (z) thenature of the applicable technology or market significantly changes such that the above calculations do
not result in a reasonable Net Sales calculation, Illumina and Developer will negotiate in good faith anappropriate and reasonable Net Sales value.
1.38“NMPA” means the National Medical Products Administration, or any successor thereto.

1.39“Other IP” is defined in Section 6.6(a).

1.40 “Other IVD System Components” means instruments, reagents, and other components
other than an IVD Test Kit, IVD Hardware, Sequencing Consumables, and LRM Software Module, thatare specified in the IVD Plan to be Developed and Commercialized by Developer as part of the IVD
System.

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1.41 “Person” means an individual or firm, trust, corporation, partnership, joint venture(whether entity‐based or by contract), limited liability company, association, unincorporatedorganization, or other legal or governmental entity.
1.42
thereto.

“PMDA” means the Japan Pharmaceuticals and Medical Devices Agency, or any successor

1.43 “Receiving Party” means a Party who receives Confidential Information from the otherParty or its Representatives or Advisors.
1.44 “Regulatory Approval” means all approvals, licenses, consents, authorizations, clearances
and CE‐IVD marking (including self‐certification when applicable) from applicable Regulatory
Authorities required to Commercialize the IVD Test Kit (together with the LRM Software Module), IVD
System, Sequencing Consumables, or IVD Hardware (as the context requires) in a given jurisdiction.
1.45 “Regulatory Authority” means any national, supranational, regional, state or local
regulatory agency, administration, department, bureau, commission, council or other governmental
entity including the FDA, the EMA, the PMDA, the NMPA, the MHRA and any notified body or otherequivalent entity, involved in the granting or receipt of Regulatory Approvals.
1.46“Reporting Period” is defined in Section 5.3.

1.47 “Representatives” means, with respect to a Party, its Affiliates, and such Party’s and its
Affiliates’ respective directors, officers, employees, contractors, consultants, Subcontractors andagents.
1.48“Revenue Share” is defined in Section 5.2.

1.49 “Sequencing Consumables” means the Illumina diagnostic core sequencing consumables
specified in the applicable IVD Plan for each IVD Test Kit.
1.50 “Subcontractor” means a Third Party (including a Distributor) to which Developer has
subcontracted any of its Development or Commercialization obligations under this Agreement inaccordance with, and to the extent permitted under, the terms and conditions of this Agreement.
1.51 “Subject Test” means a genetic test performed by or on behalf of Developer or its Affiliate
using an IVD Test Kit to test samples in exchange for payment.
1.52 “Supply Agreement” means the Supply Agreement entered into by the Parties on______________.
1.53“Term” is defined in Section 11.1.

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1.54 “Territory” means, for each IVD Test Kit, the jurisdiction(s) specified in the IVD Plan in which
Developer will seek Regulatory Approval and Commercialize the IVD Test Kit, which jurisdiction(s) may
include any jurisdiction(s) worldwide where the IVD Hardware has the appropriate Regulatory
Approval.
1.55 “Third Party” means any party other than: (a) Developer or any of its Affiliates; or (b)Illumina or any of its Affiliates.
1.56“Third Party IP” means any IP owned or controlled by a Third Party.

1.57“Withholding” is defined in Section 5.6.

1.58 “WGS Assay” means an assay that sequences all or substantially all of the genome to adepth greater than 10x and reports information concerning nucleotide base calls or variants innucleotide sequence, structure, or copy number; provided, however, that WGS Assay does not include
any such assay that reports only genome‐wide signals such as (a) DNA fragmentation patterns or (b)nucleotide base modification such as methylations.
2.

DEVELOPMENT OF IVD TEST KITS
2.1

Development of the IVD Test Kits.

(a) From time to time throughout the Term, Developer will submit to Illumina written
proposals for IVD Plans concerning IVD Test Kits to be Developed under this Agreement for Illumina’s
review and approval. Developer may Develop up to three IVD Test Kits under this Agreement. The
Parties will in good faith negotiate commercially reasonable terms (e.g. with respect to timelines,
territory, regulatory activities, etc.) for each proposed IVD Plan. Illumina may not unreasonably reject
any proposed IVD Plan.
(i) Without limiting Illumina’s right to reasonably reject any proposed IVD Plan,
Illumina may reject, in its discretion, any proposed IVD Plan that: (A) is reasonably likely to cause
Illumina or its Affiliate not to comply with Law, or result in a breach of any agreement or otherarrangement to which Illumina or its Affiliate is a party, (B) would result in an IVD Test Kit that isreasonably likely to be used in a manner that is contrary to ethical guidelines promulgated byestablished national and international ethical bodies; (C) is reasonably likely to require Illumina toengage in any Development activities after expiration of the Term; (D) is not technologically feasible
or would require IVD Hardware or Sequencing Consumables to be used in a manner outside standard,
published, specifications or Illumina’s standard terms and conditions of sale; (E) is reasonably likely toresult in an IVD Test Kit that violates or infringes upon the IP of a Third Party; or (F) requires Illumina
to perform activities not contemplated by this Agreement (specifically including any matter set forthin Section 2.3(e) or (f)).
(ii) Upon agreement on the terms of such IVD Plan and execution by the Parties inan amendment to this Agreement pursuant to Section 13.8, each IVD Plan will be incorporated into
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this Agreement in Exhibit A. An IVD Plan may only be amended by written agreement pursuant to
Section 13.8. In the event of any conflict between an IVD Plan and this Agreement, this Agreement
will govern and control unless the IVD Plan expressly provides to the contrary.
(b) Developer will use commercially reasonable efforts to Develop, at its sole cost andexpense, each IVD Test Kit in accordance with the IVD Plan and will provide to Illumina written reports
reasonably summarizing its Development efforts as reasonably requested by Illumina from time totime.
(c) Developer will purchase from Illumina the IVD Hardware and Sequencing
Consumables necessary for performance of each IVD Plan pursuant to Section 2.2 below.
(d) Illumina will develop and verify the LRM Software Module for each IVD Test Kit
pursuant to the IVD Plan and Section 2.4 below.
(e) Illumina will, subject to Section 2.3, use commercially reasonable efforts to maintainexisting Regulatory Approvals, and new Regulatory Approvals once obtained, for each IVD Hardware
and related Sequencing Consumables in the Territory, during the applicable Change Period and for five
years thereafter, in accordance with the IVD Plan and this Agreement.
(f) Developer will use commercially reasonable efforts to seek, obtain, and maintain
Regulatory Approvals for each IVD Test Kit and the corresponding LRM Software Module in the Field in
the Territory, in accordance with the IVD Plan and this Agreement.
(g) Illumina will, subject to Section 2.3, provide reasonable consultation with respect toDeveloper seeking, obtaining, and maintaining Regulatory Approvals for each IVD Test Kit and LRM
Software Module in the Field in the Territory during the Term, as requested by Developer.
(h) Illumina will provide reasonable consultation with respect to performance
optimization of IVD Test Kits, which consultation will not involve technical Development or testing.
(i) Illumina’s Development obligations under this Agreement will be limited to the
obligations expressly specified in Sections 2.1(a)‐(h) above. For the avoidance of doubt, andnotwithstanding anything in this Agreement to the contrary, nothing in this Agreement requires, ormay be construed to require, Illumina or its Affiliates to (A) modify IVD Hardware or Sequencing
Consumables or develop new IVD Hardware or Sequencing Consumables; or (B) engage in any
technical development or studies with respect to an IVD Test Kit or IVD System, except to the extent
necessary to Develop the LRM Software Module as described in Section 2.4.
(j) For clarity, Developer will be solely responsible, at Developer’s sole cost and expense,
for: (i) Developing each IVD Test Kit; (ii) testing and validating each IVD Test Kit and related LRM
Software Module (including analytical or pre‐clinical studies, validation studies, stability studies, andclinical studies) in connection with the IVD System; and (iii) preparing and submitting regulatory filings
and obtaining Regulatory Approvals for the IVD Test Kit and related LRM Software Module.
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2.2
Supply and Purchase of IVD Hardware and Sequencing Consumables. Developer willpurchase the IVD Hardware and Sequencing Consumables required to perform each IVD Plan from
Illumina. All IVD Hardware and Sequencing Consumables purchased by Developer for Development of
IVD Test Kits under this Agreement will be purchased under the Supply Agreement.
2.3

Regulatory Matters.

(a) From time to time upon Developer’s request, Illumina will provide Developer with an
updated list of all Regulatory Approvals obtained for the NovaSeqDx. For clarity, Illumina makes norepresentation, warranty, or guarantee that NovaSeqDx will receive Regulatory Approval in any
jurisdiction.
(b) Developer will own and retain all right, title, and interest in and to all Regulatory
Approvals for, and all regulatory documentation covering, the IVD System, other than the IVD
Hardware and Sequencing Consumables. Developer will be responsible for all interactions with
Regulatory Authorities and will (at its sole cost and expense) prepare all regulatory documentation andsubmit all regulatory filings to the respective Regulatory Authorities in the Territory with regard to the
IVD System other than IVD Hardware and Sequencing Consumables in accordance with the IVD Plan.
(c) Developer will keep Illumina informed of any material regulatory filings and othermaterial regulatory activities related to the IVD Test Kits and related LRM Software Modules to theextent that such information is relevant to Illumina’s obligations under this Agreement.
(d) Illumina will own and retain all right, title, and interest in and to all Regulatory
Approvals and all regulatory documentation covering the IVD Hardware and related Sequencing
Consumables. Illumina will be responsible for all interactions with Regulatory Authorities with regard
to the IVD Hardware and related Sequencing Consumables.
(e) Notwithstanding anything to the contrary, Illumina will not be required under thisAgreement or any IVD Plan to obtain any Regulatory Approval or to otherwise expand or modify any
Regulatory Approval for Sequencing Consumables or IVD Hardware (including any expanded sample
type claim or additional Regulatory Approval in any jurisdiction(s)).
(f) Notwithstanding anything to the contrary, Illumina will not be required under thisAgreement to provide any regulatory or other support for: (i) site‐specific regulatory submissions, site‐
specific applications, or site‐specific registrations before the FDA (or any similar submissions,applications, or registrations before any other Regulatory Authority); (ii) expansions of indications or
intended uses of an IVD Test Kit in any field other than the Field; or (iii) Development orCommercialization of an IVD Test Kit outside the Field or the Territory.
(g) The Parties will in good faith consider any guidance and feedback obtained from
Regulatory Authorities in response to Developer’s attempts to obtain Regulatory Approval for IVD Test
Kits and related LRM Software Modules, including guidance and feedback obtained during pre‐‐ 11 ‐

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submission meetings (or foreign equivalent), and if necessary will work together in good faith tonegotiate a corresponding amendment to the IVD Plan (e.g., timelines, scope, or limits to support) toaddress any such guidance and feedback in a mutually acceptable manner as deemed reasonably
necessary by the Parties to address such feedback, subject to Section 2.3(e) and (f).
(h) During the Term, each Party will maintain ISO 13485 and MDSAP Quality Management
Certificates applicable to each IVD System and will continue to retain an internationally recognizednotified body to conduct all ISO 13485 and MDSAP audits, and any other applicable audits for which a
notified body is required.
(i) For the avoidance of doubt, Illumina will be the “Legal Manufacturer” of the IVD
Hardware and Sequencing Consumables as that term is defined in the Medical Device Regulation (EU2017/745) and the In Vitro Diagnostic Regulation (EU 2017/746), and Developer will be the Legal
Manufacturer of the IVD Test Kit, LRM Software Module, and Other IVD System Components.
2.4

Development of LRM Software Modules.

(a) Illumina will develop and verify each LRM Software Module pursuant to the IVD Planin accordance with the specifications agreed upon in the IVD Plan; provided, however, that if an IVD
Plan specifies that Developer will provide access to the Converter Software separately from the rest of
the LRM Software Module, Developer will be solely responsible for all testing and verification of theConverter Software. Promptly after Developer’s receipt of the development version of the LRM
Software Module from Illumina, and within the period of time specified in the IVD Plan (the“Acceptance Period”), Developer will perform testing of the IVD Test Kit with the LRM Software
Module to confirm it meets the specification requirements set forth in the IVD Plan (the “AcceptanceTest”).
(b) If an LRM Software Module fails the Acceptance Test, Developer will promptly notify
Illumina. Illumina will use commercially reasonable efforts to remedy the issue and resubmit the LRM
Software Module to Developer for a new Acceptance Test, to be completed in accordance with Section
2.4(a). This process will continue until the LRM Software Module passes or is deemed to pass the
Acceptance Test.
(c) After successful completion of the Acceptance Test, Illumina will verify that the LRM
Software Module meets all of its specified requirements and provide Developer with a software
requirement document, software verification protocol, and verification test report. Developer may
submit these documents in seeking Regulatory Approval for the IVD Test Kit and LRM Software
Module.
(d) Developer will be solely responsible for validating each LRM Software Module and its
performance relative to the IVD Test Kit and IVD System. In the event that the validation of the IVD
Test Kit and IVD System fails and requires changes to the LRM Software Module, the Parties will
negotiate in good faith such changes for such LRM Software Module, and the acceptance andcorrection provisions of Sections 2.4(a) and (b) will again apply.
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CONFIDENTIAL(e) As between the Parties, Illumina will retain ownership of the LRM Software Modules
and all IP embodied therein or relating thereto. Following Regulatory Approval of each LRM Software
Module pursuant to the IVD Plan, or when otherwise specified in the IVD Plan, Illumina will deliver to
Developer an executable version of the LRM Software Module wrapped in an installer package,
including instructions for installation.
(f) Developer will not receive the source code for any LRM Software Module. Developer
may not, directly or indirectly, on its own behalf or by assisting or enabling any Affiliate or Third Party:(i) modify, adapt, improve, translate, reverse engineer, decompile, disassemble, or create derivative
works of any LRM Software Module; (ii) attempt to defeat, avoid, by‐pass, remove, deactivate, orotherwise circumvent any software protection mechanisms in any LRM Software Module, including
without limitation, any such mechanism used to restrict or control the functionality of any LRM
Software Module; or (iii) attempt to access or derive the source code or the underlying ideas,algorithms, structure, or organization form of any LRM Software Module.
2.5

Modification and Termination of IVD Plans.

(a) If at any time Illumina contends it is not reasonable to continue performing under an
IVD Plan (including for the reasons set forth in Section 2.1(a)(i) above), or that an IVD Plan or either
Party’s performance thereunder is contrary to the terms and conditions of this Agreement, the Parties
will in good faith discuss and negotiate potential amendments to the IVD Plan or modifications to theParties’ activities under the IVD Plan in order to address such belief. Notwithstanding anything to thecontrary, Illumina will not be required to perform activities with respect to an IVD Plan described in
Section 2.1(a)(i).
(b) Developer may in its discretion terminate an IVD Plan for any or no reason without
terminating the rest of this Agreement by providing 30 days prior written notice to Illumina. If
Developer terminates an IVD Plan: (i) the Parties will promptly negotiate in good faith a close‐out plan;and (ii) each Party will cease performing all work not necessary for the orderly close‐out of the IVD Planor for the fulfillment of any regulatory requirements required by applicable Law to terminate theProject.
3.

COMMERCIALIZATION OF IVD TEST KITS
3.1

Commercialization and Support.

(a) During the Term, Developer will use commercially reasonable efforts to: (i)Commercialize each IVD Test Kit and distribute the LRM Software Module for use with each IVD Test
Kit in the Territory; (ii) provide product support and technical support for each IVD Test Kit and LRM
Software Module in a manner consistent with industry standards; and (iii) promptly refer to Illumina all
support inquiries which Developer has reasonably determined to be caused by, or directed to, the IVD
Hardware or Sequencing Consumables. For clarity, except to the extent expressly provided in thisAgreement, Developer will be solely responsible, at Developer’s sole cost and expense, for‐ 13 ‐

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Commercializing the IVD Test Kit and distributing the related LRM Software Module to its Customers
for use with the IVD System.
(b) During the Term, Illumina will use commercially reasonable efforts to: (i) provide
product support and technical support for the IVD Hardware and Sequencing Consumables in the
Territory, including providing support to Developer’s Customers, in accordance with its standard
warranty and customer service practices; (ii) provide second‐tier product and technical support for the
LRM Software Module to Developer; and (iii) promptly refer to Developer all support inquiries which
Illumina has reasonably determined to be caused by, or directed to, an IVD Test Kit or LRM Software
Module. Developer will advise Customers that they may purchase the IVD Hardware and Sequencing
Consumables from Illumina. During the Change Period, Illumina will sell IVD Hardware and Sequencing
Consumables to Customers in the Territory (directly or indirectly through its Affiliates and authorized
distributors) in accordance with Illumina’s standard sales practices. Illumina will use commerciallyreasonable efforts to continue selling Sequencing Consumables to Customers in the Territory (directly
or indirectly through its Affiliates and authorized distributors) in accordance with Illumina’s standard
sales practices for an additional five years after the Change Period.
(c) Subject to, and contingent upon compliance with, the terms and conditions of thisAgreement, Developer may: (i) use Subcontractors to Develop IVD Test Kits on Developer’s behalf; (ii)use Distributors to purchase and resell IVD Test Kits on Developer’s behalf; and (iii) use Affiliates toDevelop and Commercialize IVD Test Kits on Developer’s behalf; in each case ((i)‐(iii)) in the ordinary
course of business; provided that: (iv) Developer will be responsible for all acts and omissions of such
Subcontractors and Affiliates; (v) Developer will be liable for all acts and omissions of such
Subcontractors or Affiliates that constitute a breach of this Agreement, or that would constitute a
breach of this Agreement if performed (or not performed) by Developer, and such acts and omissions
will constitute Developer’s breach of this Agreement; and (vi) without limiting the generality of theforegoing, for each such subcontract, Developer will include in its subcontract a right for Illumina to
audit the books, records, data or other information of such Subcontractor to confirm compliance withthe terms and conditions of this Agreement.
(d) Developer and its Affiliates may sell, transfer, or otherwise dispose of IVD Test Kits
only to Affiliates, Distributors, and Customers, and only in the ordinary course of business. Affiliates
and Distributors may sell, transfer, or otherwise dispose of IVD Test Kits only to Customers, and only inthe ordinary course of business. Developer and its Affiliates and Distributors may not attempt tocircumvent or reduce Revenue Share payable to Illumina by entering into any arrangement not in theordinary course of business, including sham arrangements, straw man arrangements, or otherarrangements with the intent of, or having a primary purpose of, avoiding or reducing Revenue Sharepayable to Illumina.
(e) IVD Test Kits and LRM Software Modules may be Commercialized only under aDeveloper‐owned brand and not as a private label or “white label” for any Person other thanDeveloper or its Affiliate or under any original equipment manufacturer (OEM) arrangement. Without
limiting the foregoing, Developer and its Affiliates may not Develop or Commercialize any IVD Test Kit
or distribute any LRM Software Module on behalf of any other Person or otherwise act in any manner‐ 14 ‐

CONFIDENTIAL

that implies the source of any IVD Test Kit or LRM Software Module is Person other than Developer or
its Affiliate.
3.2

Commercialization of LRM Software Modules.

(a) Developer is solely responsible for distributing each LRM Software Module to its
Customers pursuant to the rights granted in Section 6.3. Without limiting the generality of theforegoing, Developer is solely responsible for: (i) providing each LRM Software Module to its
Customers, by distributing the installer package or installing the LRM Software Module; and (ii) except
to the limited extent expressly set forth in Section 3.2(b) below, supporting each LRM Software Moduleand its Customers’ use of each LRM Software Module. Developer will use and distribute the installer
package for the LRM Software Modules only for the purposes expressly authorized under thisAgreement. For clarity, Developer and its Distributors may only install, or allow its Customers to
install, the LRM Software Module on the IVD Hardware for which it was designed, and for use with the
IVD Test Kit for which it was designed, as specified in the IVD Plan.
(b) Following the passing of the Acceptance Test and verification of each LRM Software
Module pursuant to the IVD Plan:(i)if, during the Change Period, either Party identifies any malfunction in the LRM
Software Module that interferes with the functionality of the LRM Software Module and other similarsoftware modules developed for Developer or Illumina’s other Third Party in vitro diagnostic test kit
developers for use with the IVD Hardware, such Party will notify the other, and Illumina will, atIllumina’s cost, use commercially reasonable efforts to remedy such malfunction and deliver to
Developer a new version of the LRM Software Module (for distribution to its Customers pursuant tothis Section 3.2) within a commercially reasonable period of time, subject to the Acceptance Test
process set forth in Section 2.4(a);(ii)
if, during or after the Change Period, either Party identifies any othermalfunction in the LRM Software Module (not otherwise covered by Section 3.2(b)(i)) that interfereswith the functionality of the LRM Software Module, the Parties will negotiate in good faith the terms
under which Illumina may remedy such malfunction; and(iii)
if Developer desires that Illumina provide any fixes, enhancements,
modifications, or improvements to the LRM Software Module not addressed by Section 3.2(b)(i) or (ii)the Parties will negotiate in good faith the terms under which Illumina may perform such work at
Illumina’s discretion.
(c) For clarity, Illumina will not be required to provide any enhancements, modifications,
fixes, or improvements to any LRM Software Module except to the limited extent set forth in Section
3.2(b) above.
(d) For Illumina’s existing NextSeq 550Dx diagnostic sequencing instrument, the LRM
Software Module is, as of the Effective Date, an on‐instrument local run manager software module, but‐ 15 ‐

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the Parties acknowledge that the NovaSeqDx may use different software to accomplish similarfunctionality, which software will constitute the LRM Software Module for the NovaSeqDx. If theterms and conditions of this Agreement with respect to LRM Software Modules do not reasonably
accommodate the NovaSeqDx LRM Software Modules, or if the application of those terms andconditions to the NovaSeqDx LRM Software Modules leads to results that materially differ from theintent and effect of the terms and conditions of this Agreement with respect to LRM Software
Modules, the Parties will in good faith negotiate replacement terms with respect to such NovaSeqDx
LRM Software Modules that match the intent and effect of the terms and conditions of this agreementwith respect to LRM Software Modules as closely as is reasonably possible.
3.3 Insurance. During the Term and for five years thereafter, Developer and Illumina will eachself‐insure or maintain, at its sole expense, commercial and product liability insurance relating to its
components of the IVD Systems that is comparable in type and amount to the insurance customarily
maintained by such Party with respect to similar products that are Commercialized in the applicable
Territory.
4.

QUALITY

4.1
Routine Quality Audits. During the Term, Illumina agrees to allow Developer (at Developer’ssole expense) to audit Illumina’s operations that pertain to Sequencing Consumables, IVD Hardware,and LRM Software Modules, upon 60 days’ prior written notice, during normal business hours, no more
often than once per calendar year only to the extent necessary to satisfy Developer’s obligations underapplicable Law and regulatory requirements. The locations, times, dates, scope, and goals for suchaudits must be reasonably agreed upon in writing by the Parties before commencement of the audit.
4.2
For‐Cause Quality Audits. During the Term, Developer will have the right to audit Illumina’s
facilities and records that pertain to Sequencing Consumables, IVD Hardware, and LRM Software
Modules upon 30 days’ prior written notice, during normal business hours, related specifically to aformal supplier corrective action request (SCAR) previously issued by Developer associated with thescope and corrective actions associated with said SCAR.
4.3
Process. Developer will comply with all of Illumina’s reasonable security and safety policies
when conducting any audit pursuant to Sections 4.1 or 4.2. All information learned by Developer in thecourse of such audit is Illumina Confidential Information. If requested by Illumina, Developer will
ensure that any person conducting the audit sign Illumina’s confidentiality agreement before
conducting such audit; provided that the terms thereof are substantially similar to the confidentiality
obligations in this Agreement. Developer will provide Illumina written copies of all findings of any suchaudit within 30 days of completion of the audit.
4.4

Product Changes and Discontinuance.

(a) Planned Changes. Illumina acknowledges that planned changes to, or discontinuationsof, IVD Hardware, Sequencing Consumables, or LRM Software Modules may incur costs and risks forboth Parties and will only be considered during the Change Period with a commercially reasonable‐ 16 ‐

CONFIDENTIAL

rationale and justification. Illumina will provide Developer with written notice of any major plannedchanges to, or discontinuation of, any IVD Hardware, Sequencing Consumable, or LRM Software
Modules during the Change Period at least six months before making such a change, or twelve months
before a discontinuation, in order to allow Developer to plan accordingly. As used in this paragraphand in (b) below, a “major” change is a change that Illumina reasonably expects to require Developer
to make a filing or submission to any Regulatory Authority in connection with obtaining or maintaining
Regulatory Approval for the IVD Test Kit. If Illumina reasonably determines that such a change would
require Developer to submit an “180 Day Supplement” to the FDA (as defined in 737(4)(c) of theFederal Food, Drug, and Cosmetic Act (21 U.S.C. 379i(4)(c)), or a similar filing in any other applicablejurisdiction, such that the six or twelve month notice period described above would not allow
Developer sufficient time to generate data required for such 180 Day Supplement, Illumina will use
commercially reasonable efforts to provide notice sufficiently in advance of such change to enable
Developer to generate such data, and will work in good faith with Developer to assist Developer totimely submit the 180 Day Supplement.
(b) Unplanned Changes. Illumina reserves the right to make unplanned changes to IVD
Hardware, Sequencing Consumables, and LRM Software Modules due to safety, applicable Law,
regulatory requirements, failure to conform to specifications, or Force Majeure. Illumina will notify
Developer in writing as soon as reasonably practicable of any such unplanned major changes during
the Term.
(c) Discontinuation. Other than the changes described in (a) and (b) above, Illumina willcontinue to sell and provide support for the IVD Hardware and Sequencing Consumables in the originalform used for Development and regulatory submission for an IVD Test Kit on the terms set forth hereinin the Territory throughout the Change Period, and will use commercially reasonable efforts tocontinue selling Sequencing Consumables and providing support for the IVD Hardware for five years
after the Change Period. Illumina makes no representation, warranty, or covenant that the IVD
Hardware or Sequencing Consumables will be manufactured or sold outside the Territory or after the
Change Period (except as set forth in the preceding sentence with the respect to the additional five
year period). Except as set forth in (a) and (b) and Section 2.5 above, Illumina is under no obligation to
notify Developer of any changes to, or discontinuation of, existing products or Development of new
products.
(d) Transition. Following a notice under (a) or (b) above with respect to Sequencing
Consumables or LRM Software Modules (or software having similar functionality), upon Developer’s
reasonable request, Illumina will discuss with Developer the steps necessary to transition to modified
or successor Sequencing Consumables or LRM Software Modules, if any, and use commerciallyreasonable efforts to assist Developer with such transition in accordance with this Agreement.
(e) Illumina Obligations to Customers. Nothing in this Section 4.4 is intended to limit any
contractual obligations of Illumina to Customers pursuant to any separate agreements between
Illumina and Customers with respect to the supply of IVD Hardware or Sequencing Consumables.

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CONFIDENTIAL

5.

FINANCIAL CONSIDERATION

5.1
Milestone Payments. Developer will pay the non‐refundable, non‐creditable, milestone
payments to Illumina set forth in Exhibit B upon achievement of the milestones set forth therein (the“Milestone Payments”). Developer will promptly notify Illumina in writing of its achievement of eachmilestone in Exhibit B (email is acceptable), and Illumina will promptly acknowledge such achievement(email is acceptable), and (unless otherwise specified in Exhibit B) Developer will make the specified
Milestone Payment no later than 30 days after sending such notice.
5.2
Revenue Share. As partial consideration for the right to Develop and Commercialize the IVD
Test Kits for use with IVD Hardware and Sequencing Consumables, and other activities andconsideration of Illumina contemplated by this Agreement, Developer will pay Illumina six percent (6%)
of Net Sales (such amount referred to as the “Revenue Share”).
5.3
Reporting. Developer will furnish to Illumina a written report within 30 days after the closeof each calendar quarter (March 31, June 30, September 30, and December 31) (each, a “Reporting
Period”) showing on a product‐by‐product and country‐by‐country basis: (a) the number of IVD Test
Kits sold, transferred, or otherwise disposed of, and the number of IVD Test Kits used by Developer and
its Affiliates in performing Subject Tests, during the Reporting Period; (b) the gross amount charged
during the Reporting Period for IVD Test Kits; (c) a detailed explanation of any IVD Test Kits sold,transferred, or otherwise disposed of during the Reporting Period in any transaction that was not atarm’s length; (d) a reasonably detailed calculation of Net Sales during the Reporting Period, including aseparate revenue calculation for any Subject Tests; (e) the exchange rates used in determining the
Revenue Share; and (f) the amount of Revenue Share payable to Illumina. All currency conversions will
be made using Developer’s standard financial reporting procedures which will be consistently appliedin accordance with GAAP. Developer will provide such additional information concerning the
calculation of the Revenue Share as Illumina may reasonably request from time to time to enable
Illumina to confirm the accuracy of such calculation. All such reports will be prepared consistently inaccordance with GAAP, except to the extent otherwise expressly required by this Agreement. If it
becomes necessary to satisfy Illumina accounting obligations under applicable Law, upon Illumina’s
request Developer will provide a good faith estimate of Revenue Share payable to Illumina within 10
Business Days after the close of each quarter.
5.4
Payments. Payment of the Revenue Share earned during a Reporting Period will accompany
each report described in Section 5.3. Other than payment for Sequencing Consumables and IVD
Hardware purchased by Developer (which will be governed by the Supply Agreement), all payments
required under this Agreement from Developer will be paid in the United States Dollars by wiretransfer pursuant to the wire instructions as Illumina may from time to time provide. Developer may
not deduct or withhold any wire transfer fees, bank charges, or any other fees or charges incurred inconnection with making such payment. If Developer fails to make any payment on or before the date
it is due, interest will accrue on such payment on a daily basis from the date such payment was
originally due at a rate equal to 1.5% per month compounded monthly, or the maximum amountallowed by Law, if lower, until paid. Developer’s obligations to pay interest on late payments may not
be construed to limit or restrict any other right or remedy which may be available to Illumina. In the‐ 18 ‐

CONFIDENTIAL

event of a dispute regarding any payments due and owing hereunder, all undisputed amounts will be
paid when due, and the balance, if any, will be paid promptly after settlement of the dispute, including
any accrued interest thereon.
5.5
Records. Developer will maintain written records with respect to its activities andoperations under this Agreement, including the Development and Commercialization of IVD Test Kits,in sufficient detail to enable Illumina or its designated accountants to confirm compliance with theterms of this Agreement and the accuracy and completeness of the amounts of Net Sales and Revenue
Share reported to, and all amounts paid or payable to, Illumina. Such records will be complete andaccurate in all material respects. Developer will maintain such records during the Term and for five
years thereafter. During the Term and for five years thereafter, Developer agrees to allow Illumina (atIllumina’s sole expense, except as provided below) to audit such records upon 30 days’ prior written
notice, during normal business hours, no more often than once per calendar year only to the extent
necessary to confirm compliance with the terms of this Agreement and the accuracy and completenessof the calculation of Net Sales, the amounts of Revenue Share, and any other amounts payable toIllumina. The expense of such audit will be borne by the Illumina; provided, however, that, if an
underpayment of 5% or more for any Reporting Period is discovered, then such expenses will be paidby Developer. Without limiting Illumina’s rights under this Agreement, if any such audit determinesthat additional amounts were owed to Illumina during any period, Developer will pay such amounts(including interest thereon from the date such amounts were originally payable) within 30 days after
the date Illumina notifies Developer of such additional amounts. The locations, times, and dates forsuch audits must be reasonably agreed upon in writing by the Parties before commencement of theaudit. Illumina will comply with all of Developer’s reasonable security and safety policies when
conducting any audit. All information learned by Illumina in the course of such audit is Developer
Confidential Information. If requested by Developer, Illumina will ensure that any person conducting
the audit sign Developer’s confidentiality agreement before conducting such audit; provided that theterms thereof are substantially similar to the confidentiality obligations in this Agreement.
5.6
Taxes. All amounts payable to Illumina under this Agreement are exclusive of and arepayable without withholding or deduction for goods and services taxes, value added taxes, other taxes,
customs duties, tariffs, or other charges required by Law from time to time. Without limiting theforegoing, if applicable Law requires any amount to be withheld, charged, deducted, or assessedagainst any amount owed by Developer to Illumina under this Agreement (each, a “Withholding”),
Developer will timely withhold and pay all such Withholdings, and will promptly furnish Illumina withcertificates evidencing payment of all such Withholdings. If applicable Law requires Illumina to pay
such Withholding, and will not permit Developer to pay such Withholding, the Parties will in good faithnegotiate a payment mechanism that results in Illumina receiving and retaining the full amounts towhich it is entitled net of the Withholding.
6.

INTELLECTUAL PROPERTY

6.1 Development Rights. Subject to, and contingent upon compliance with, the terms andconditions of this Agreement and the Supply Agreement, Developer’s or its Affiliate’s purchase of
Sequencing Consumables and IVD Hardware from Illumina and its Affiliates under this Agreement and‐ 19 ‐

CONFIDENTIAL

the Supply Agreement confers upon Developer, its Affiliate, or Subcontractor, by exhaustion, thepersonal, limited, non‐exclusive, non‐transferable, right under Illumina Core IP to use the purchased
Sequencing Consumables and IVD Hardware to Develop the applicable IVD Test Kit during the Termsolely for use in the Territory in the Field with the IVD Hardware, Sequencing Consumables and LRM
Software Module strictly in accordance with this Agreement and the IVD Plan for such IVD Test Kit. For
clarity, the rights granted in this Section 6.1 expressly exclude any and all rights to, and Developer and
its Affiliates and Subcontractors may not, make, have made, sell, have sold, offer for sale, or haveoffered for sale Sequencing Consumables or IVD Hardware. The Parties agree that this Section 6.1 isintended to, and does, alter the effect of the exhaustion of patent rights that could otherwise result if
the sale of Sequencing Consumables and IVD Hardware was made without restriction.
6.2 Right of Reference. Subject to, and contingent upon compliance with, the terms andconditions of this Agreement, Illumina hereby grants to Developer the right to permit the FDA (orsimilar Regulatory Authority in a Territory designated in the applicable IVD Plan) to refer to the device
listing for the IVD Hardware and Sequencing Consumables in support of seeking Regulatory Approval
for the IVD Test Kit and LRM Software Module in the Territory during the Term, and to incorporate theinformation contained in such device listing into the submission(s) for the IVD Test Kit and LRM
Software Module by reference, to the extent set forth in and in accordance with the applicable IVD
Plan for such IVD Test Kit. To the extent required by the FDA (or similar Regulatory Authority in a
Territory designated in the applicable IVD Plan) Illumina will prepare and submit a letter ofauthorization documenting such right of reference.
6.3
Right to Distribute LRM Software Modules. Subject to, and contingent upon compliancewith, the terms and conditions of this Agreement, Illumina hereby grants to Developer the personal,
non‐transferable, non‐exclusive, right during the Term to: (a) reproduce and distribute each LRM
Software Module installer package that has been delivered to, and accepted by, Developer as set forthin Section 3.2(a), solely in executable object code, to its Customers in the Territory and authorize such
Customers to install and use the LRM Software Module on the IVD Hardware for which it was designedwith the IVD Test Kit for which it was designed; and (b) install each such LRM Software Module on its
Customers’ IVD Hardware in the Territory by running such installer package and authorize such
Customers to use the LRM Software Module on the IVD Hardware for which it was designed with the
IVD Test Kit for which it was designed. Developer may sublicense the foregoing rights to its Affiliates
and Distributors.
6.4 Rights Granted to Illumina. Subject to, and contingent upon compliance with, the terms andconditions of this Agreement, Developer hereby grants to Illumina and its Affiliates a limited,
nonexclusive, non‐transferable, non‐sublicensable license under any IP of Developer as necessary for,and for the sole purpose of allowing, Illumina to perform its obligations under this Agreement(including development of LRM Software Modules) during the Term.
6.5

All Rights Reserved.

(a) No IP is assigned or otherwise transferred under this Agreement. Without limiting thegenerality of the foregoing, as between the Parties, each Party or its Affiliate will retain all IP: (i) that is‐ 20 ‐

CONFIDENTIAL

Controlled by the Party or its Affiliate before the Effective Date; (ii) that is developed by the Party or its
Affiliate, or which otherwise comes under the Control of the Party or its Affiliate, during the Term
independently from performing under this Agreement; or (iii) that is developed, generated, conceived,or reduced to practice by or on behalf of the Party or its Affiliate in the course of performing under thisAgreement.
(b) Except as expressly stated in this Section 6 and in the Supply Agreement, no rightunder any Illumina IP is granted expressly, by implication, estoppel, or otherwise, under thisAgreement. Except as expressly stated in this Section 6 no right under any Developer IP is granted,
expressly, by implication, estoppel, or otherwise, under this Agreement.
6.6

Other IP.

(a) Developer is solely responsible for determining whether it has, and for obtaining, allrights to IP that are necessary for Developer’s Development and Commercialization of IVD Test Kits,
including any Third Party IP and any additional rights from Illumina or Illumina’s Affiliates that are notexpressly granted in this Agreement or in the Supply Agreement (together with Third Party IP, “OtherIP”). Illumina makes no representation, warranty, or guarantee that Developer’s IVD Test Kits will not
violate or infringe Other IP, and expressly disclaims and excludes any such representation, warranty, or
guarantee, and any statement or implication otherwise, to the maximum extent permitted by Law.
Notwithstanding anything in this Agreement to the contrary, Developer assumes all risks associatedwith not obtaining any required rights to Other IP.
(b) If any IVD Test Kit or any component thereof violates or infringes any Third Party IP,
Developer, at its sole cost and expense, will use commercially reasonable efforts to either (i) obtain alicense under IP or otherwise procure the right to Commercialize such IVD Test Kit, or (ii) replace ormodify such IVD Test Kit or component thereof so that it no longer violates or infringes such IP.
(c) Upon Developer’s request during the Term, Illumina will in good faith consider
granting a license to Developer or its Affiliate under any Other IP Controlled by Illumina or its Affiliates
for the purpose of Developing and Commercializing one or more IVD Test Kits. Any such license will beon commercially reasonable terms.
6.7 Rights are Personal. The rights granted in this Section 6 are personal, non‐sublicensable(except to the limited extent permitted in Section 6.3 above), and non‐transferable. Any purported
transfer, grant, or other conveyance of the rights granted in this Section 6 (or any portion of suchrights), except to the limited extent permitted in Section 6.3 above, will be null, void, and of no effect.
7.

CONFIDENTIAL INFORMATION
7.1

Disclosure and Use Restriction.

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CONFIDENTIAL(a)
Except to the extent expressly authorized by this Agreement or otherwise agreed inwriting by the Parties, the Receiving Party will keep confidential and may not publish or otherwise
disclose or transfer the Disclosing Party’s Confidential Information to any Third Party.
(b)
The Receiving Party may disclose the Disclosing Party’s Confidential Information only
to its Advisors and Representatives who are bound by confidentiality and non‐use restrictions at least
as restrictive as those set forth in this Agreement and who have a specific need to know in order for
the Receiving Party to be able to perform its obligations and exercise its express rights under thisAgreement, and only to the extent necessary for such purposes. Each Party will be responsible for any
conduct by its respective Advisors and Representatives that constitutes a breach of this Section 7 orthat would be a breach of this Section 7 by such Party had such Party engaged in such conduct itself.
Such conduct will be deemed and is a breach of this Agreement by such Party.
(c)
The Receiving Party will use at least the same standard of care as it uses to protect
proprietary or confidential information of its own (but in no event less than a reasonable standard ofcare) to ensure that it and its Advisors and Representatives do not disclose or make any unauthorized
use of the Disclosing Party’s Confidential Information. The Receiving Party will promptly notify theDisclosing Party upon discovery of any unauthorized disclosure or use of the Disclosing Party’s
Confidential Information.
(d)
The confidentiality and non‐use obligations in this Agreement will continue
throughout the Term and for seven years thereafter.
7.2 Authorized Disclosure. The Receiving Party may disclose the Disclosing Party’s Confidential
Information to the extent that such disclosure is:(a)made in response to a valid order of a court of competent jurisdiction or othergovernmental authority; provided, however, that the Receiving Party will, to the extent permitted byLaw, give written notice to the Disclosing Party within five Business Days of receipt of such order andgive the Disclosing Party a reasonable opportunity to quash or limit the scope of such order and toobtain a protective order requiring that the Confidential Information and documents that are thesubject of such order be held in confidence by such court or governmental authority or, if disclosed, be
used only for the purposes for which the order was issued; and provided, further, that if a disclosure
order is not quashed or limited in scope, or a protective order is not obtained, the Confidential
Information disclosed in response to such court or governmental authority will be limited to that
information which is legally required to be disclosed in response to such court or governmental
authority;(b)otherwise required by Law; provided, that the Receiving Party: (i) promptly notifies
the Disclosing Party of the specifics of such requirement (providing a copy of the Confidential
Information to be disclosed) at least 30 days before the actual disclosure (or as soon as reasonably
possible before the actual disclosure if such 30 day prior notice is impractical under the circumstances)or promptly after actual disclosure if prior disclosure is impractical under the circumstances; (ii)discloses only the minimal information necessary to satisfy such requirement; (iii) reasonably‐ 22 ‐

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cooperates with the Disclosing Party to prevent or limit such disclosure; and (iv) provides the Disclosing
Party with a copy of Confidential Information actually disclosed; or(c)made by the Receiving Party with the prior written consent of the Disclosing Party.

7.3 Authorized Use. The Receiving Party may use the Disclosing Party’s Confidential Information
solely to the extent necessary for the Receiving Party to perform its obligations and exercise its express
rights under this Agreement, and such use will be otherwise subject to all restrictions and limitations
set forth in this Agreement.
7.4

Agreement; Publicity.

(a)
The existence and terms of this Agreement are both Parties’ Confidential Information.
Subject to Section 7.2 above, each Party must obtain the prior written consent of the other Party on allpress releases or other public announcements relating to this Agreement, provided that a Party is not
required to obtain prior written consent of the other Party for press releases or public disclosures that
repeat information that has been previously publicly disclosed pursuant to this Section 7.4.
(b)Neither Party may use any trademark of the Party, or any derivation thereof, without
the advance express written consent of the other Party, which consent may be granted or withheld in
the other Party’s sole discretion.
7.5 Post‐Termination. Following expiration or termination of this Agreement for any reason,
upon the request of the Disclosing Party, the Receiving Party will, at the Disclosing Party’s option: (a)return all materials containing the Disclosing Party’s Confidential Information to the Disclosing Party;or (b) destroy all materials containing the Disclosing Party’s Confidential Information and certify such
destruction in writing to the Disclosing Party; provided that the Receiving Party will be authorized toretain one copy for the purpose of determining any continuing obligation with respect thereto.
Notwithstanding the foregoing, the Receiving Party will not be required to destroy or delete electronic
copies (including emails) that have become embedded in its electronic storage systems throughroutine backup processes. Any Confidential Information so retained will continue to be held pursuant
to all of the confidentiality, non‐use, and other terms of this Agreement.
7.6 GRAIL Firewall. Illumina shall establish a firewall designed to prevent any GRAIL personnel(and any Illumina personnel carrying out activities with respect to the GRAIL business or products) fromaccessing any Confidential Information obtained by or made available to Illumina relating to Developeror its business or products, whether pursuant to this Agreement or otherwise.
8.

REPRESENTATIONS AND WARRANTIES
8.1

General Warranties. Each Party represents and warrants that:‐ 23 ‐

CONFIDENTIAL(a)
Such Party is duly organized, validly existing, and in good standing under the laws ofjurisdiction of domicile, and has all requisite power and authority to carry on its business as suchbusiness is now being conducted;(b)This Agreement has been duly authorized, executed, and delivered by such Party andconstitutes the legal, valid, and binding obligation of such Party, enforceable against such Party inaccordance with its terms, except as enforceability may be limited by Law relating to bankruptcy,
receivership, or similar laws affecting creditors’ rights generally or by equitable principles relating toenforceability;(c)
Such Party has all necessary rights, powers, and authority to enter into this Agreement
and to carry out its obligations hereunder;(d)
The execution and delivery of this Agreement and the performance of such Party’s
obligations hereunder (i) do not conflict with or violate any requirement of applicable Law or any
provision of the articles of incorporation, bylaws, limited partnership agreement or any similar
instrument of such Party, as applicable, in any material way, and (ii) do not conflict with, violate, or
breach or constitute a default or require any consent under, any applicable Law or any contractual
obligation by which such Party is bound; and(e)In performing its activities related to this Agreement, it will comply with all applicable

Laws.
8.2
Additional Representations, Warranties and Covenants of Developer. Developer hereby
represents, warrants, and covenants to Illumina that any and all IVD Test Kits Commercialized by or on
behalf of Developer and its Affiliates under this Agreement will be manufactured and tested inaccordance with applicable Laws, including cGMP, and will not be adulterated or misbranded within
the meaning of the United States Food, Drug and Cosmetic Act, 21 U.S.C. Section 301 et. seq. (“FDCA”)
or other applicable Laws.
8.3 Additional Representations, Warranties and Covenants of Illumina. Illumina hereby
represents, warrants, and covenants to Developer that any and all IVD Hardware and Sequencing
Consumables Commercialized by or on behalf of Illumina and its Affiliates for use with an IVD System
will be manufactured and tested in accordance with applicable Laws, including cGMP, and will not be
adulterated or misbranded within the meaning of the FDCA or other applicable Laws.
FOR CLARITY, AND NOTWITHSTANDING ANYTHING TO THE CONTRARY: (A) ILLUMINA’S SOLE
REPRESENTATIONS, WARRANTIES, AND INDEMNIFICATION AND DEFENSE OBLIGATIONS WITH RESPECTTO PRODUCTS PURCHASED BY DEVELOPER AND ITS AFFILIATES ARE CONTAINED EXCLUSIVELY IN THE
SUPPLY AGREEMENT; AND (B) ILLUMINA’S SOLE REPRESENTATIONS, WARRANTIES, AND
INDEMNIFICATION AND DEFENSE OBLIGATIONS WITH RESPECT TO PRODUCTS PURCHASED BY ANYCUSTOMER WILL BE CONTAINED EXCLUSIVELY IN ANY AGREEMENT(S) BETWEEN ILLUMINA AND THE
CUSTOMER.

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THE REPRESENTATIONS AND WARRANTIES EXPRESSLY SET FORTH IN THIS AGREEMENT ARE THE
PARTIES’ EXCLUSIVE REPRESENTATIONS AND WARRANTIES WITH RESPECT TO THIS AGREEMENT, AND
ALL OTHER EXPRESS OR IMPLIED REPRESENTATIONS AND WARRANTIES (INCLUDING THE IMPLIEDWARRANTIES OF MERCHANTABILITY, NON‐INFRINGEMENT OF THIRD PARTY RIGHTS AND FITNESS FOR
A PARTICULAR PURPOSE) ARE EXPLICITLY DISCLAIMED.
9.

ALLOCATION OF RISKS

9.1
Developer’s Indemnification Obligations. Developer will defend, indemnify, and holdharmless Illumina, its Affiliates, and their respective officers, directors, representatives, employees,
successors, and assigns (“Illumina Indemnitees”), from and against any and all claims, causes of action,and proceedings brought or asserted by a Third Party (“Claims”), and all associated losses, liabilities,
damages, fines, and penalties of any and every kind, including legal expenses and reasonable
attorneys’ fees (“Losses”) to the extent resulting from, relating to, or arising out of:(a)any Developer Indemnitee’s breach of this Agreement, including any obligation,
representation, warranty, or covenant hereunder;(b)
any Developer Indemnitee’s gross negligence or intentional misconduct in performing
or failing to perform under this Agreement;(c)any Developer Indemnitee’s violation of applicable Law in performing under thisAgreement; or(d)any Developer Indemnitee’s Development or Commercialization of an IVD Test Kit,
Other IVD System Component, or Subject Test, including any violation or infringement of Third Party IP,
caused by an IVD Test Kit, Other IVD System Component, or Subject Test;in each case except to the extent resulting from, relating to, or arising out of matters for which Illumina
is obligated to defend, indemnify, and hold harmless Developer Indemnitees pursuant to Section 9.2.
For purposes of determining whether or not any violation or infringement of Third Party IP is caused by(a) an IVD Test Kit, Other IVD System Component, or Subject Test or (b) IVD Hardware or Sequencing
Consumables, for purposes of clause (d) above and Section 9.2(d) below, the intent of the Parties is todetermine whether and to what extent the claims of such Third Party IP are primarily directed to (a)the IVD Test Kit, Other IVD System Component, or Subject Test or (b) IVD Hardware or Sequencing
Consumables.
9.2
Illumina’s Indemnification Obligations. Illumina will defend, indemnify, and hold harmless
Developer, its Affiliates, and their respective officers, directors, representatives, employees,
successors, and assigns (“Developer Indemnitees”), from and against any and all Claims and Losses tothe extent resulting from, relating to, or arising out of:‐ 25 ‐

CONFIDENTIAL(a)any Illumina Indemnitee’s breach of this Agreement, including any obligation,
representation, warranty, or covenant hereunder;(b)
any Illumina Indemnitee’s gross negligence or intentional misconduct in performing or
failing to perform under this Agreement;(c)
any Illumina Indemnitee’s violation of applicable Law in performing under thisAgreement; or(d)any Illumina Indemnitee’s Development or Commercialization of IVD Hardware or
Sequencing Consumables when used as part of an IVD System, including any violation or infringementof Third Party IP caused by IVD Hardware or Sequencing Consumables when used as part of an IVD
System;in each case except to the extent resulting from, relating to, or arising out of matters for which
Developer is obligated to defend, indemnify, and hold harmless Illumina Indemnitees pursuant to
Section 9.1.
9.3 Indemnification Procedures. Each Party’s obligations under Sections 9.1 and 9.2 areconditioned on the Party seeking indemnification: (a) giving the indemnifying Party prompt written
notice of the Claim; provided, however, that failure to provide such notice will not relieve theindemnifying Party from its liability or obligation hereunder, except to the extent of any material
prejudice as a direct result of such failure; (b) cooperating with the indemnifying Party, at theindemnifying Party’s expense, in connection with the defense and settlement of the Claim, including
providing accurate and complete information reasonably requested by the indemnifying Party; and (c)permitting the indemnifying Party to solely control the defense and settlement of the Claim; provided,
however, that the indemnifying Party may not settle the Claim, enter into or otherwise consent to an
adverse judgment or order, or make any admission as to liability or fault that would adversely affectthe indemnified Party, without the indemnified Party’s prior written consent, which will not be
unreasonably withheld or delayed. Further, the indemnified Party will have the right to participate(but not control) and be represented in any suit or action by counsel of its selection at its own cost andexpense.
9.4

Product‐related Indemnification.

(a)Notwithstanding anything in this Agreement to the contrary, Illumina’s defense,
indemnification, and hold harmless obligations with respect to Sequencing Consumables and IVD
Hardware purchased from Illumina or its Affiliates by Developer or its Affiliates under the Supply
Agreement are limited solely to those obligations expressly provided in the Supply Agreement for suchproducts, and such terms will supersede and control over any other indemnification obligations of
Illumina and its Affiliates provided in this Agreement. Furthermore, neither Party will be entitled toany duplicative recovery under this Agreement and the Supply Agreement.
(b)Notwithstanding anything in this Agreement to the contrary, Illumina’s and its‐ 26 ‐

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Affiliates’ defense, indemnification, and hold harmless obligations with respect to Sequencing
Consumables and IVD Hardware purchased by a Customer are limited solely to those obligations
provided in any agreement(s) between Illumina or its Affiliate and the Customer.
10.

LIMITATIONS ON LIABILITIES

10.1 EXCEPT AS STATED IN SECTION 10.3, AND EXCEPT WITH RESPECT TO LIABILITY ARISINGFROM A PARTY’S DEFENSE AND INDEMNIFICATION OBLIGATIONS UNDER SECTION 9.1 OR 9.2 (BUT
ONLY WITH RESPECT TO DAMAGES ACTUALLY PAID OR TO BE PAID BY THE INDEMNIFIED PARTY TO THE
THIRD PARTY CLAIMANT), BUT OTHERWISE TO THE FULLEST EXTENT PERMITTED BY LAW, IN NO EVENTWILL ILLUMINA OR ITS AFFILIATES BE LIABLE TO DEVELOPER OR ITS AFFILIATES, NOR WILL DEVELOPEROR ITS AFFILIATES BE LIABLE TO ILLUMINA OR ITS AFFILIATES, FOR COSTS OF PROCUREMENT OFSUBSTITUTE PRODUCTS OR SERVICES, LOST PROFITS, DATA OR BUSINESS, OR FOR ANY INDIRECT,
SPECIAL, INCIDENTAL, EXEMPLARY, CONSEQUENTIAL, OR PUNITIVE DAMAGES OF ANY KIND ARISINGOUT OF OR IN CONNECTION WITH THIS AGREEMENT, HOWEVER ARISING OR CAUSED AND ON ANY
THEORY OF LIABILITY (WHETHER IN CONTRACT, TORT (INCLUDING NEGLIGENCE), STRICT LIABILITY,MISREPRESENTATION, BREACH OF STATUTORY DUTY, OR OTHERWISE).
10.2 EXCEPT AS STATED IN SECTION 10.3 BELOW, AND EXCEPT TO THE EXTENT ARISING FROM: (I)DEVELOPER’S BINDING COMMITMENT TO PURCHASE PRODUCT PURSUANT TO ONE OR MORE ISSUED
AND ACCEPTED PURCHASE ORDERS; (II) DEVELOPER’S REVENUE SHARE OBLIGATIONS; OR (III) A
PARTY’S DEFENSE AND INDEMNIFICATION OBLIGATIONS UNDER SECTION 9; BUT OTHERWISE TO THE
FULLEST EXTENT PERMITTED BY LAW, EACH PARTY’S CUMULATIVE LIABILITY UNDER OR ARISING OUT
OF THIS AGREEMENT, INCLUDING ANY CAUSE OF ACTION IN CONTRACT, NEGLIGENCE, OR TORT(INCLUDING STRICT LIABILITY), WILL NOT EXCEED THE GREATER OF (A) TWO TIMES THE AGGREGATEAMOUNTS PAID BY DEVELOPER TO ILLUMINA UNDER THIS AGREEMENT IN THE FIVE YEAR PERIODPRIOR TO THE EVENT GIVING RISE TO SUCH DAMAGES AND (B) $15,000,000.
10.3 THE LIMITATIONS OF LIABILITY IN THIS SECTION 10 APPLY EVEN IF A PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH LIABILITY, AND NOTWITHSTANDING ANY FAILURE OF ESSENTIALPURPOSE OF ANY LIMITED REMEDY. NOTWITHSTANDING SECTION 10.1 AND 10.2 AND ANYTHING TO
THE CONTRARY, THIS AGREEMENT DOES NOT LIMIT LIABILITY OF EITHER PARTY FOR ANY
INFRINGEMENT OF THE OTHER PARTY’S IP, SUCH PARTY’S WILLFUL MISCONDUCT, OR FRAUD.
11.

TERM AND TERMINATION

11.1 Term. The term of this Agreement will begin on the Effective Date and continue until thedate 10 years from the later of (a) the date the NovaSeqDx receives Regulatory Approval in the UnitedStates or (b) the date the GRAIL Transaction closes, unless terminated earlier in accordance with thisSection 11 or extended by amendment pursuant to Section 13.8 (the “Term”).
11.2 Early Termination. Without limiting any other rights of termination expressly provided inthis Agreement or under Law, this Agreement may be terminated early as follows:‐ 27 ‐

CONFIDENTIAL(a)
Breach of Provision. If a Party materially breaches this Agreement and fails to curesuch breach within 60 days after receiving written notice of the breach from the other Party, then theother Party may terminate this Agreement with immediate effect by providing written notice oftermination to the breaching Party; provided, however, that if such breach is curable, but notreasonably curable within such 60‐day period, and the breaching Party is using commerciallyreasonable efforts to cure the breach, then such cure period will be extended to not longer than 180
days.
(b)
Bankruptcy and Insolvency. A Party may terminate this Agreement, effective
immediately upon written notice, if the other Party becomes the subject of a voluntary or involuntary
petition in bankruptcy, for winding up of that Party, or any proceeding relating to insolvency,
receivership, administrative receivership, administrative liquidation, or voluntary arrangement orscheme of arrangement with its creditors that is not dismissed or set aside within 60 days.
(c)Right of Developer to Terminate for Convenience. Developer may, at any time upon
notice to Illumina, terminate this Agreement for any or no reason.
11.3 Effect of Expiration or Termination.
(a)Rights Terminate. On the effective date of the expiration (except to the extent
specified Section 11.3(b)) or termination of this Agreement, all rights granted by Illumina under thisAgreement will terminate, and Developer will, and will procure that its Affiliates and Subcontractors
will, as soon as is reasonably practicable, cease the Development and Commercialization of all IVD Test
Kits.
(b)
Continued Commercialization. After expiration of the Term (but not termination ofthis Agreement), Developer may continue Commercializing IVD Test Kits that were launched before
expiration of the Term on an IVD Test Kit‐by‐IVD Test Kit and Territory‐by‐Territory basis; for so long as
Illumina is still Commercializing the Sequencing Consumables and servicing and supporting the IVD
Hardware in the applicable Territory. Developer’s continued Commercialization of IVD Test Kits would
be subject to the terms and conditions of this Agreement, including the Revenue Share.
(c)Surviving Obligations. The following provisions will survive any termination or
expiration of this Agreement: Sections 1, 2.3(b), 2.3(d), 2.3(i), 2.4(f), 3.3, 5, 6.5, 6.7, 7‐10 (inclusive),
11.3, 11.4, and 13, and any other provisions or Exhibits necessary to give effect to the surviving
provisions. Termination or expiration of this Agreement will not relieve the Parties of any liability or
obligation that accrued under this Agreement before the effective date of such termination or
expiration, nor preclude either Party from pursuing all rights and remedies it may have under thisAgreement, at Law, or in equity with respect to any breach of this Agreement.
11.4 No Damages for Termination or Expiration. NEITHER PARTY WILL BE LIABLE TO THE OTHERPARTY FOR DAMAGES OF ANY KIND (INCLUDING WITHOUT LIMITATION DAMAGES ON ACCOUNT OFPRESENT OR PROSPECTIVE PROFITS, OR ON ACCOUNT OF EXPENDITURES, INVESTMENTS, OR
COMMITMENTS MADE IN CONNECTION WITH THIS AGREEMENT, OR IN CONNECTION WITH THE‐ 28 ‐

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DEVELOPMENT OR MAINTENANCE OF THE BUSINESS OR GOODWILL OF THE OTHER PARTY) BY REASON
OF EXPIRATION OF THIS AGREEMENT OR PROPER EXERCISE OF ITS RIGHT TO TERMINATE THISAGREEMENT IN ACCORDANCE WITH THE TERMS AND CONDITIONS SET FORTH IN THIS AGREEMENT,AND EACH PARTY EXPRESSLY WAIVES ANY RIGHT IT MAY HAVE TO RECEIVE ANY SUCH DAMAGES.
12.

COMPLIANCE

12.1 General Compliance. In performing under this Agreement, each Party will at all times
comply with applicable Law.
12.2 IVD Test Kits. Specifically, and without limiting the foregoing, Developer (a) will not
Commercialize any IVD Test Kit or Subject Test in any jurisdiction where such activities are prohibitedby Law, or in any manner prohibited by Law, and (b) will at all times comply with good clinicalpractices, good laboratory practices, good manufacturing practices (including all quality systems
regulations), and the Illumina Regulatory and Safety Compliance Rider attached to this Agreement as
Exhibit C.
12.3 Sunshine Act. Each Party will reasonably cooperate with the other Party in its efforts
toward ensuring that all government price and gift reporting, fraud and abuse, sales, marketing, andpromotional practices with respect to the IVD System meet the standards required by applicable Law,
including the Physician Payments Sunshine Act and similar state laws, as well as applicable guidelines
concerning the advertising of in vitro diagnostics and medical devices.
12.4 Cooperation in Investigation. Each Party agrees to reasonably cooperate, and to cause its
Representatives to reasonably cooperate, in good faith with the other Party and any Regulatory
Authority at the other Party’s request: (a) to investigate the extent of any potential violations ofapplicable Laws in connection with this Agreement; and (b) to participate in any inspection or audit by
any Regulatory Authority.
12.5 Requests for Information. Each Party will use reasonable efforts to comply with reasonable
requests for information, including answering questionnaires and narrowly tailored inquiries, to enable
the other Party to comply with all applicable Laws and respond to requests for information from
Regulatory Authorities.
13.

GENERAL

13.1 Arbitration. If any dispute arises from or relates to this Agreement, (the “Dispute”), otherthan claims involving infringement, validity, or enforceability of IP (whether Illumina’s or Developer’s),
or about the scope of IP in this Agreement, the Parties shall submit the matter to confidential binding
arbitration to determine final terms and conditions of the agreement, or to settle the dispute as to theterms of the agreement.
(a)Prior to submitting any matter to arbitration, Illumina and Developer shall each
designate a contact having the proper authorization to resolve the Dispute in a final and binding‐ 29 ‐

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fashion, who shall meet in person or by telephone for a period of thirty (30) days (or such other periodof time as Illumina and the Developer shall mutually agree) in an attempt to resolve the Dispute ingood faith.
(b)
The arbitration proceeding shall be conducted in accordance with the Commercial
Arbitration Rules of the AAA and as otherwise described in this Section 13.1.
(c)
The location of the arbitration proceeding will be mutually agreed by the Parties. In
the event there is no agreement as to location, the arbitration proceeding will take place in New York
City, NY.
(d)Within five Business Days of the commencement of an arbitration, Developer andIllumina each shall furnish a legally binding writing to the other committing to maintain theconfidentiality of the arbitration and of any written statement and discovery materials exchanged
during the arbitration, and to limit the use of any such materials to the arbitration.
(e)Upon written request by either Party to the other Party, the Parties shall promptly
negotiate in good faith to appoint an appropriate Arbitrator. If the Parties are not able to agree withinten (10) days after the receipt by a Party of the written request in the immediately preceding sentence,
the AAA shall be responsible for selecting an Arbitrator with relevant experience related to the disputeof at least ten (10) years and to do so within fifteen (15) days of being approached by a Party. The fees
and costs of the Arbitrator and the AAA shall be shared equally (50%/50%) by the Parties. Each Party
to the arbitration shall bear its own legal fees and expenses.
(f)Within twenty (20) days after the designation of the Arbitrator, the Parties shall eachsimultaneously submit to the Arbitrator and one another a written statement of their respective
positions on such Dispute. Each Party shall have fifteen (15) days from receipt of the other Party’s
submission to submit a written response thereto. The Arbitrator shall have the right to meet with theParties, either alone or together, as necessary to make a determination. Further, the Arbitrator shallhave the right to request information and materials and to require and facilitate discovery as it shalldetermine is appropriate in the circumstances, taking into account the needs of the Parties and thedesirability of making discovery expeditious and cost‐effective determinations. In reaching a decision,
the Arbitrator may consider only documents exchanged in discovery between the Parties, testimony
explaining the documents and the Parties’ written statements and other materials submitted andarguments made by counsel.
(g)
No later than thirty (30) days after the Parties each submit their written statements to
the Arbitrator, or as otherwise agreed by the Parties, the Arbitrator shall make a determination by
selecting the resolution proposed by one of the Parties that as a whole is the most consistent with thisAgreement and the most fair and reasonable to the Parties in light of the totality of the circumstances.
The Arbitrator shall provide the Parties with a written statement setting forth the basis of thedetermination in connection therewith, provided that, the Arbitrator shall not have the authority toalter any explicit provision of this Agreement. The decision of the Arbitrator shall be final, binding andconclusive, absent manifest error; judgment on the award may be entered in any court having‐ 30 ‐

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jurisdiction. Neither Party may disclose the existence, content, or results of any arbitration without theprior written consent of both Parties, unless required by law.
(h)
The Parties may, by agreement, modify any time periods specified in this Section 13.1.
At any time after the commencement of arbitration, the Parties may agree to suspend the arbitration,
for periods not to exceed fourteen (14) days in the aggregate, to attempt to resolve their dispute
through negotiation. The Parties shall effectuate such suspension through a joint writing filed with theAAA. Either Party may terminate the suspension at any time by filing with the AAA a writing calling forthe arbitration to resume.
13.2 Choice of Law. This Agreement shall be governed by, and construed in accordance with, thelaws of the State of New York, without giving effect to the conflicts‐of‐law principles thereof.
13.3 Injunctive Relief; Cumulative Remedies. Each Party acknowledges that its breach of Section
2.4(f), 3.1(d), 3.1(e), 3.2(a), 7, or 13.5 may cause irreparable injury to the other Party for whichmonetary damages would not be an adequate remedy, and the other Party will therefore be entitled toseek injunctive relief (including specific performance) with respect to any such breach or threatened
breach without posting a bond or other security as a condition for obtaining any such relief. The rights
and remedies provided to each Party in this Agreement are cumulative and in addition to any otherrights and remedies available to each Party under this Agreement, at Law, or in equity.
13.4 Severability; No Waiver. If any term or provision of this Agreement is invalid, illegal, or
unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability will not affect any otherterm or provision of this Agreement or invalidate or render unenforceable such term or provision in
any other jurisdiction, subject to the remainder of this Section 13.4. Upon a determination by a court
or arbitrator having jurisdiction that any term or provision of this Agreement is invalid, illegal, or
unenforceable, the Parties will negotiate in good faith to modify this Agreement to effect the original
intent of the Parties as closely as possible in order that the transactions contemplated hereby beconsummated as originally contemplated to the greatest extent possible. The failure or delay of either
Party to exercise any right or remedy provided in this Agreement or to require any performance of any
term of this Agreement may not be construed as a waiver, and no single or partial exercise of any rightor remedy provided in this Agreement, or the waiver by either Party of any breach of this Agreement,
will prevent a subsequent exercise or enforcement of, or be deemed a waiver of any subsequent
breach of, the same or any other term of this Agreement. No waiver of any right, condition, or breachof this Agreement will be effective unless in writing and signed by both Parties.
13.5 Assignment; Illumina Affiliates; Third Party Beneficiaries.
(a)Developer may not assign or transfer this Agreement (including any assignment ortransfer (including vesting) by operation of law, and specifically including any merger or othertransaction whereby the surviving entity is any entity other than the Developer entity that has
executed this Agreement as of the Effective Date), or delegate, sublicense, or subcontract any rights or
obligations under this Agreement, other than delegation to the extent expressly permitted in this‐ 31 ‐

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Agreement, without the prior written consent of Illumina, which consent may be withheld at Illumina’ssole discretion.
(b)
Illumina may assign or transfer this Agreement, and may delegate, sublicense or
subcontract any or all of its rights and obligations under this Agreement, to one or more of its
Affiliates. Illumina invoices and other documentation may come from an Illumina Affiliate, andDeveloper will honor those just as if they came directly from Illumina.
(c)
Any delegation, subcontracting, sublicensing, assignment or transfer of thisAgreement made in contravention of the terms hereof will be null and void. Subject to the foregoing,
this Agreement will be binding on and inure to the benefit of the Parties’ respective successors andpermitted assigns. There are no Third Party beneficiaries to this Agreement and no term of thisAgreement is enforceable under the Contracts (Rights of Third Parties) Act 1999 by a person or entity
who is not a Party to this Agreement. The Parties may rescind or terminate this Agreement or vary anyof its terms in accordance with their rights under this Agreement and by Law, without the consent of
any Third Party.
13.6 Notices. All notices required or permitted under this Agreement will be in writing, in English,
and will be deemed received only when: (a) delivered personally; or (b) one day after deposit with acommercial express courier specifying next day delivery or, for international courier packages, twodays after deposit with a commercial express courier specifying two‐day delivery, with written
verification of receipt. All notices will be sent to the following or any other address designated by a
Party using the procedures set forth in this Section:
If to Illumina:

If to Developer:

Illumina, Inc.
5200 Illumina Way
San Diego, CA 92122
Attn: SVP, Corporate Development andStrategic PlanningWith a copy to: Legalnotices@illumina.com
13.7 Force Majeure. Neither Party will be in breach of this Agreement nor liable for any failure to
perform or delay in the performance of this Agreement attributable in whole or in part to any Force
Majeure; provided, however, that in each such case the affected Party will use reasonable efforts toavoid such occurrence and to remedy it promptly. The affected Party will give prompt notice of any
such cause to the other Party. The affected Party will be excused from such of its obligations as it isdisabled from performing during the period of Force Majeure; provided, however, that such affected
Party commences and continues to take reasonable and diligent actions to cure such cause.
Performance hereunder will be promptly resumed after the applicable Force Majeure event has been
remedied. Developer’s payment obligations are not affected by this provision except to the extent the‐ 32 ‐

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Force Majeure affects financial institutions and, as a result, the financial institutions cannot complete
the transaction necessary for Developer to satisfy its payment obligations.
13.8 Entire Agreement; Amendment. This Agreement, together with the Supply Agreement,
represents the entire agreement between the Parties regarding the subject matter hereof andsupersedes all prior discussions, communications, agreements, and understandings of any kind andnature between the Parties with respect to the Development and Commercialization of the IVD Test
Kits. The Parties acknowledge and agree that by entering into this Agreement, they do not rely on any
statement, representation, assurance, or warranty of any Person other than as expressly set out in thisAgreement. Each Party agrees that it will have no right or remedy (other than for breach of contract)
in respect of any statement, representation, assurance, or warranty (whether made negligently or
innocently) other than as expressly set forth in this Agreement. Nothing in this Section 13.8 will
exclude or limit liability for fraud. No amendment to this Agreement (including changes to any IVD
Plan or addition of any IVD Plan) will be effective unless in writing and signed by both Parties.
13.9 Relationship of the Parties. The Parties are independent contractors under this Agreement
and nothing in this Agreement may be construed as creating a partnership, joint venture, or agency
relationship between the Parties, or as granting either Party the authority to bind or contract any
obligation in the name of the other Party or to make any statements, representations, warranties, orcommitments on behalf of the other Party.
13.10 Headings; Interpretation. Sections, titles, and headings in this Agreement are forconvenience only and are not intended to affect the meaning or interpretation hereof. Wheneverrequired by the context, the singular term includes the plural, the plural term includes the singular, andthe gender of any pronoun includes all genders. As used in this Agreement except as the context mayotherwise require, the words “include,” “includes,” “including,” and “such as” are deemed to befollowed by “without limitation” or “but not limited to,” whether or not they are in fact followed bysuch words or similar words, and “will” and “shall” are used synonymously. Except as otherwise
expressly provided, “discretion” means sole and absolute discretion. Except as expressly stated, anyreference to “days” will be to calendar days, any reference to “calendar month” will be to the monthand not a 30 day period, and any reference to “calendar quarter” will mean the first three calendar
months of the year, the fourth through sixth calendar months of the year, the seventh through ninth
calendar months of the year, and the last three calendar months of the year. Whenever the last day
for the exercise of any right or the discharge of any obligation hereunder falls on, or any notice isdeemed to be given on, a non‐Business Day, the Party having such right or obligation will have until
5:00 pm PST on the next succeeding Business Day to exercise such right or to discharge such obligationor the Party giving notice will be deemed to have given notice on the next succeeding Business Day.
No usage of trade, course of performance, or other regular practice between the Parties may be used
to alter the terms and conditions of this Agreement. Unless otherwise expressly provided in thisAgreement, any agreement, instrument, or statute defined or referred to means such agreement,
instrument, or statute as from time to time amended, modified, or supplemented, including (in thecase of agreements or instruments) by waiver or consent and (in the case of statutes) by succession ofcomparable successor statutes and references to all attachments thereto and instruments
incorporated therein. The Parties have participated jointly in the negotiation and drafting of this‐ 33 ‐

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Agreement. If an ambiguity or question of intent or interpretation arises, this Agreement will be
construed as if drafted jointly by the Parties and no presumption or burden of proof will arise favoringor disfavoring any Party because of the authorship of any provision of this Agreement.
13.11 Legal Compliance. Nothing in this Agreement is intended, or should be interpreted, toprevent either Party from complying with, or to require a Party to violate, any applicable Law. Should
either Party reasonably conclude that any portion of this Agreement is or may be in violation of achange in a Law made after the Effective Date, or if any such change or proposed change would
materially alter the amount or method of compensating Illumina for services performed for, or
Revenue Share owed by, Developer, or would materially increase the cost of Illumina’s performancehereunder, the Parties agree to negotiate in good faith written modifications to this Agreement as may
be necessary to establish compliance with such changes, and to reflect applicable changes incompensation warranted by such legal changes, with any mutually agreed upon modifications added tothis Agreement by written amendment in accordance with Section 13.8 of this Agreement.
13.12 Counterparts and Signatures. This Agreement may be executed in one or morecounterparts, each of which will be deemed to be an original, and all of which will constitute one andthe same instrument. Delivery of an executed counterpart of a signature page of this Agreement by
PDF or other electronic transmission will be effective as delivery of a manually executed original
counterpart of this Agreement. The Parties agree that the execution of this Agreement by exchanging
pdf signatures, and/or by industry standard electronic signature software, will have the same legal
force and effect as the exchange of original signatures.
13.13 Costs. Except as expressly provided in this Agreement, each Party will pay its own costs
incurred in connection with the negotiation, preparation, execution, and performance under thisAgreement and any documents referred to in it.
13.14 Non‐Exclusive Relationship. Each Party acknowledges and agrees that, during the Term andthereafter, nothing in this Agreement will create any form of exclusive relationship between theParties with respect to the subject matter of this Agreement.
13.15 Further Assurances. Each Party will execute and deliver such further documents and takesuch further actions as the other Party may reasonably request to evidence and implement theprovisions and intent of this Agreement.

[SIGNATURES ON NEXT PAGE]‐ 34 ‐

CONFIDENTIAL

SIGNATURE PAGE TO
IVD TEST KIT AGREEMENT – NOVASEQDXILLUMINA

Developer

Illumina, Inc.

____________________________________

By:

By:

Name:

Name:

Title:

Title:

Date:

Date:

CONFIDENTIAL
EXHIBIT A
IVD PLANSCONFIDENTIAL
EXHIBIT B
MILESTONE PAYMENTS
Developer will pay to Illumina the following Milestone Payments upon achievement of thecorresponding milestones.
•

Tech Access Fee: $15,000,000, paid one‐time only, within five Business Days of the Effective Date.

•

Development Milestone Payments (per IVD Test Kit):$5,000,000 total per IVD Test Kit
50% of the total amount will be due upon Developer’s acceptance of the LRM Software
Module for the IVD Test Kit (which may not be unreasonably withheld, conditioned, ordelayed) and the remaining 50% will be due upon the first Regulatory Approval of the IVD
Test Kit (in any jurisdiction).

CONFIDENTIAL
EXHIBIT CILLUMINA REGULATORY AND SAFETY COMPLIANCE RIDER
In performing under the attached agreement (the “Agreement”) with Illumina, Inc. and/or its affiliate(referred to below as “Illumina”) the contracting party (referred to below as “Contractor”) will comply
with the following provisions, to the extent applicable. To the extent Contractor is permitted to retain
subcontractors in the performance of the Agreement as applicable, Contractor will ensure that its
subcontractors comply with the following provisions, to the extent applicable, and the breach of any
provision below by a subcontractor will constitute a breach of the Agreement by Contractor.
Export Compliance. Contractor shall comply with all applicable export control laws with respect to theexport of or re‐ export of technical data and products that are the subject of the Agreement. Eachparty agrees to determine and secure in advance of any export, any and all licenses and permits as may
be required or reasonably required in order to export or re‐ export the products or technical data usedin connection therewith. Contractor shall notify Illumina in writing if any product or technical data
provided hereunder is or becomes subject of export control laws, including those of the United States,
such that it may require an export license.
Integrity Clause. All corruption, extortion and embezzlement are prohibited. Contractor shall not pay
or accept bribes or participate in other illegal inducements in business or government relationships.
Contractor shall conduct its business consistent with fair and vigorous competition and in compliancewith all antitrust laws. Contractor shall employ fair business practices, including accurate and truthful
advertising. Contractor represents and warrants that in connection with its performance under the
Agreement it complies with all applicable laws and regulations including those relating to sustainable
development and social responsibility such as regulations prohibiting child labor, bribes, the granting ofillegal advantages, and fair employment practices. Contractor shall neither use forced, bonded,indentured or voluntary prison labor nor child labor.
Personal Data Privacy. In the course of performance under the Agreement Contractor may receive
personal information that includes without limitation, business contact information, of customers andemployees of Illumina and Illumina’s affiliates (collectively “Personal Data”). In the event Contractor
receives any Personal Data under the Agreement, Contractor shall protect Personal Data whentransferring, using, and processing Personal Data as follows: Contractor shall: (i) provide notice about
how Contractor will protect and use Personal Data and provide, upon request, the affected individuals
with appropriate options on how to receive such notices; (ii) not transfer Personal Data to any third
party without Illumina’s express prior written consent; (iii) provide individuals with reasonable accessto their Personal Data as requested by Illumina; (iv) take all reasonable security precautions to protect
Personal Data from loss, misuse and unauthorized access, disclosure, alteration and destruction; and(v) take all reasonable steps to ensure Personal Data is reliable for its intended use when Contractor
will be using or processing Personal Data or transferring to a third party that will be using or processing
Personal Data.