EXHIBIT 10.1 

 

Certain information identified by [******] in certain sections of the Agreement
and attached Schedules are redacted because they contain information that is
commercially sensitive, not material and would be competitively harmful if
publicly disclosed.

 

DEVELOPMENT, SUPPLY AND COMMERCIALIZATION AGREEMENT

 

This Development, Supply and Commercialization Agreement (this “Agreement”),
effective as of May 19, 2020 (the “Effective Date”), is by and between Kantaro
Biosciences LLC, a Delaware limited liability company with a principal business
address of 1460 Broadway, New York, NY 10036 (“Sponsor”) and Bio-Techne
Corporation, a Minnesota corporation having a principal business address at 614
McKinley Place NE, Minneapolis, MN 55413 (“Bio-Techne”). Capitalized terms used
and not defined elsewhere in this Agreement have the meanings set forth in
Section 1 of this Agreement.

 

WHEREAS, Sponsor has been formed by and is majority owned and controlled by
Icahn School of Medicine at Mount Sinai, a New York educational corporation
(“ISMMS”);

 

WHEREAS, on February 4, 2020, pursuant to Section 564(b)(1)(C) of the FDC Act,
the Secretary of the Department of Health and Human Services (“HHS”) determined
that there is a public health emergency (the “Public Health Emergency”) that has
a significant potential to affect national security or the health and security
of United States citizens living abroad, and that involves the virus that causes
Severe Acute Respiratory Syndrome Coronavirus 2 (“SARS-CoV-2”);

 

WHEREAS, pursuant to Section 564 of the FDC Act, and on the basis of the
determination by the Secretary of the HHS, the Secretary of HHS declared that
circumstances exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of the virus that causes COVID-19
subject to the terms of an EUA;

 

WHEREAS, ISMMS developed the MS Lab Test in response to the Public Health
Emergency, and on April 15, 2020, the FDA issued the MS Lab Test EUA;

 

WHEREAS, Sponsor and ISMMS entered into the ISMMS IP License Agreement and ISMMS
TM License Agreement in order to enable Sponsor to enter into this Agreement and
fulfill certain of its obligation under this Agreement;

 

WHEREAS, Bio-Techne is in the business of developing, manufacturing and
supporting diagnostic tests and related products;

 

WHEREAS, subject to the terms and conditions of this Agreement, Sponsor desires
to (i) collaborate with Bio-Techne to co-Develop the Co-Developed Test that is
based on the MS Lab Test and that has the specifications and performance
characteristics set forth on Schedule 3.1(a) and satisfies the other criteria
set forth in this Agreement, (ii) obtain the necessary authorizations to
commercialize the Co-Developed Test as described in this Agreement, and (iii)
engage Bio-Techne to provide services in collaboration with Sponsor to
Manufacture and Commercialize Co-Developed Test Kits containing the necessary
components, labeling and instructions and meeting the other requirements of this
Agreement so as to enable providers and reference laboratories to conduct
testing that will rapidly and effectively support societal efforts to respond to
the Public Health Emergency and advance public health; and

 

 

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WHEREAS, the Parties desire to set forth the rights and obligations of each
Party (and the rights of ISMMS to the extent provided herein) with respect to
the Development of the Co-Developed Test, the Manufacturing of the Co-Developed
Test Kits and the Commercialization of the Co-Developed Test Kits:

 

NOW THEREFORE, in consideration of the mutual promises and covenants contained
herein, and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, and wishing to be legally bound
hereby, the Sponsor and Bio-Techne hereby agree as follows:

 

1.

DEFINITIONS

 

The following terms have the meanings specified or referred to in this Section
1:

 

“Action” means any claim, action, suit, corrective action plan, cause of action,
lawsuit, arbitration, audit, survey, investigation, intermediate or other
sanction, fine or penalty, written notice of violation or noncompliance,
administrative proceeding, litigation, citation, summons, subpoena, inquiry, or
investigation of any nature, civil, criminal, administrative, regulatory, or
otherwise, whether at law or in equity, before or by any Governmental Authority.

 

“Adjusted Gross Receipts” means for any calendar month (i) the amounts actually
received in cash by Bio-Techne in consideration of the sale, licensing, use,
lease, transfer or other disposition of Co-Developed Test Kits during such
calendar month in accordance with this Agreement, less (ii) the amount of any
credits or refunds for returns of or allowances for Co-Developed Test Kits
granted by Bio-Techne during such calendar month in accordance with this
Agreement and that were applied against amounts described in clause (i) of this
definition, less (iii) any losses incurred by Bio-Techne in the conversion of a
currency other than U.S. dollars in which any amount described in clause (i) of
this definition is paid, plus (iv) any gains realized by Bio-Techne in the
conversion of a currency other than U.S. dollars in which any amount described
in clause (i) of this definition is paid.

 

“Affiliate” means any Person that controls, is controlled by, or is under common
control with, a Party, directly or indirectly. For purposes of this definition,
“control” and its various forms means the possession, directly or indirectly, of
the power to direct or cause the direction of the management and policies of
such Person, whether through ownership of voting securities, by contract or
otherwise. Without limiting the generality of the foregoing, a Party will be
deemed to control another Person if such Party owns or directly or indirectly
controls more than fifty percent (50%) of the voting stock or other securities
of the Person.

 

“Agreement” has the meaning set forth in the introductory paragraph.

 

“Approved Alternative Component” has the meaning set forth in Section 9.6.

 

“Bio-Techne” has the meaning set forth in the introductory paragraph.

 

“Bio-Techne Background IP” means all Intellectual Property of Bio-Techne related
to the Development, Manufacture or Commercialization of serologic or similar
tests that Bio-Techne possesses (other than as a result of the receipt by
Bio-Techne prior to the date hereof of information communicated by ISMMS or
Sponsor related to the MS Background IP) or that, after the date hereof,
Bio-Techne develops without any contribution from ISMMS or Sponsor. Bio-Techne
Background IP shall not include MS Background IP or Jointly Developed
Intellectual Property.

 

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“Bio-Techne Indemnitees” has the meaning set forth in Section 17.1(b).

 

“Bio-Techne Licensed Marks” has the meaning set forth in Section 6.3(k).

 

“Bio-Techne NDA” means that certain Mutual Non-Disclosure Agreement entered into
by and between Sponsor and Bio-Techne, effective as of the Effective Date, as
the same may be amended from time to time.

 

“Calendar Year” means January 1 through December 31 of a given year.

 

“CLIA HC Lab” means a laboratory that is certified under Clinical Laboratory
Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a to perform high
complexity tests.

 

“Co-Developed Test” means a serologic test or tests to detect and/or measure the
presence of antibodies to the COVID-19 virus each of which is based on the MS
Lab Test, and which in the case of any particular test has the applicable
specifications and performance characteristics set forth on Schedule 3.1(a) and
required by any applicable End User-Specific Requirements and that has been
accepted by Sponsor pursuant to Section 3.1(a).

 

“Co-Developed Test Kits” means one or more assemblies of the Components and
material that an End User needs to administer the Co-Developed Test, as
Developed by Bio-Techne in accordance with this Agreement and any applicable End
User-Specific Requirements and approved by the Steering Committee in accordance
with Section 3.1(a), Section 3.1(c) and Section 8.1(a).

 

“Commercialization” means any and all activities related to the promotion,
distribution, marketing, offering for sale and selling of or otherwise granting
rights to the Co-Developed Test Kits, including advertising, educating,
planning, supporting and adhering to pricing and reimbursement approvals and
Regulatory Authorizations, investigating and responding to End User adverse
events involving the Co-Developed Test Kits, pricing, price reporting,
marketing, promoting, tracking, storing, handling, shipping, distributing,
importing, exporting, using, offering for sale, or selling the Co-Developed Test
Kits anywhere in the world, billing and collections and in each case as
responsibility for each such activity is allocated between Sponsor and
Bio-Techne in accordance with this Agreement. Commercialization excludes
activities related to the Development and/or Manufacturing of the Co-Developed
Test Kits. Without limiting the generality of the foregoing, “Commercialization”
includes all of the activities described in Section 8.1(a). When used as a verb,
“Commercialize” means to engage in Commercialization.

 

“Components” means the Original Components and any additions, replacements or
changes in and to the Original Components that have been adopted pursuant to and
as contemplated by Section 9.6, which is intended to be included as part of or
used in the Manufacture of the finished, packaged, and labeled Co-Developed Test
Kits.

 

“Confidential Information” means information that a Party owns or controls and
maintains as confidential that such Party discloses to the other Party during
the term of the Bio-Techne NDA, including without limitation, any such
information regarding products, services, research, prototypes, samples,
software, inventions, processes, formulas, technology, designs, drawings,
hardware configurations, business, and marketing. For clarity, “Confidential
Information” includes the foregoing information of a third party in possession
of the disclosing Party, that disclosing Party has a legal right to disclose to
the other Party under terms of confidentiality as set forth herein.

 

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“Contract” means any agreement, contract, lease, deed, mortgage, license,
instrument, promissory note, evidence of indebtedness, security agreement,
commitment, undertaking, indenture or joint venture, whether written or oral.

 

“COVID-19” means Coronavirus Disease 2019.

 

“Designated Executives” has the meaning set forth in Section 2.2(a).

 

“Development” means any and all activities related to researching or developing
the Co-Developed Test and the Co-Developed Test Kits or process or service,
including preclinical and clinical research, testing and development activities
relating to the discovery and/or development of product or process candidates
and submission of information and applications to a Regulatory Authority,
including toxicology, pharmacology, and other discovery, optimization, and
preclinical efforts, test method development and stability testing,
manufacturing process development, formulation development, upscaling,
Validation, delivery system development, quality assurance and quality control
development, statistical analysis, clinical studies (including pre and post
Regulatory Approval studies), and activities relating to obtaining Regulatory
Approvals, but excluding Commercialization activities, in each case as
responsibility for each such activity is allocated between Sponsor and
Bio-Techne in accordance with this Agreement. When used as a verb, “Develop”
means to engage in Development.

 

“Deviation” means departure from established procedure or specification.

 

“Effective Date” has the meaning set forth in the introductory paragraph.

 

“ELISA” means serological enzyme-linked immunosorbent assays.

 

“EMA” means the European Medicines Agency or any successor thereto.

 

“Embargoed Purchaser” has the meaning set forth in Section 8.3.

 

“Encumbrance” means any encumbrance, charge, claim, pledge, equitable interest,
lien (statutory or other), option, security interest, mortgage, hypothecation,
easement, encroachment, right of way, right of first refusal, restriction, levy
or charge of any kind, including any restriction on use, voting, transfer,
receipt of income or exercise of any other attribute of ownership.

 

“End of EUA Period” means the earlier of: (a) the effective date on which the
declaration that circumstances exist justifying the authorization of the
emergency use of in vitro diagnostic tests for detection and/or diagnosis of
COVID-19 is terminated under Section 564(b)(2) of the FDC Act or (b) the
effective date on which the EUA for any Co-Developed Test is revoked under
Section 564(g) of the FDC Act.

 

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“End User” means with respect to the Co-Developed Test Kit, a healthcare
provider, clinical laboratory, or other authorized Person that orders the
Co-Developed Test Kit to detect if there has been an immune response to COVID-19
in the diagnosis of individuals suspected of prior SARS-CoV-2 infection;
provided that the applicable healthcare provider, clinical laboratory or other
authorized Person has satisfied any qualification requirements established by
the FDA or other applicable Governmental Authority to purchase and utilize the
applicable Co-Developed Test Kit.

 

“End User-Specific Requirements” means any requirements established pursuant to
the terms of an agreement between Sponsor and any Governmental Authority or
other End-User relating to the specifications, characteristics, manufacturing
methodologies or other aspects of the Development, Manufacturing or
Commercialization of any Co-Developed Test Kit and of which Sponsor has given
Notice to Bio-Techne.

 

“Escalation Process” means the process described in Section 2.1 and Section 2.2.

 

“EUA” means an Emergency Use Authorization for emergency use of a product
pursuant to Section 564 of the FDC Act and/or any equivalent authorization
promulgated that pertains to a serological antibody test, in each case as the
same may have been amended or supplemented as of the time of any reference
thereto.

 

“EUA Compliance Protocol” has the meaning set forth in Section 9.3(a).

 

“FDA” means the United States Food and Drug Administration or any successor
entities thereto.

 

“FDC Act” means the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et
seq.), as amended as of the time of any reference thereto.

 

“Good Clinical Practices” means the then-current standards, practices and
procedures for good clinical practices in the conduct of clinical trials,
including adequate human subject protections, as promulgated or endorsed by the
FDA and other applicable Governmental Authorities, such as set forth in,
“International Conference on Harmonization - Guidance for Industry E6 Good
Clinical Practice: Consolidated Guidance,” 21 C.F.R. Parts 50, 54, 56, and 812
and relevant FDA guidance, as applicable, or as otherwise required by applicable
Law.

 

“Good Laboratory Practices” means the then-current standards, practices and
procedures for good laboratory practices by facilities that perform non-clinical
(including pre-clinical) laboratory studies, as promulgated or endorsed by the
FDA and other applicable Governmental Authorities, including as set forth in 21
C.F.R. Part 58 and relevant FDA guidance, as applicable, or as otherwise
required by applicable Law.

 

“Good Manufacturing Practices” means the then-current standards, practices and
procedures for the manufacture of drugs or medical devices, as applicable to the
Co-Developed Test Kits (including the practices of and methods to be used in,
and the facilities or controls to be used for, the manufacture, processing,
packaging, sterilizing, labeling, testing or holding of the Co-Developed Test
Kits), as promulgated or endorsed by the FDA and other applicable Governmental
Authorities, including, as applicable, as set forth in 21 C.F.R. Parts 210, 211,
and 820 and relevant FDA guidance, as applicable, or as otherwise required by
applicable Law.

 

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“Governmental Authority” means any supranational, national, federal, state,
provincial, local or foreign Person of any nature exercising executive,
legislative, judicial, regulatory or administrative functions of or pertaining
to government, including any governmental authority, agency, department, board,
commission, court, tribunal, judicial body or instrumentality of any union of
nations, federation, nation, state, municipality, county, locality or other
political subdivision thereof, whether of the United States or any other
country.

 

“Health Care Laws” means all applicable Laws relating in any way to patient care
and human health and safety, including such Laws pertaining to: (a) the
Development, Manufacture and Commercialization of drugs, serologic tests and
medical devices, including, without limitation, the FDC Act, the Public Health
Service Act, 42 U.S.C. § 201 et seq., the regulations, rules, policies, orders,
and guidance of the FDA administered, issued, or promulgated thereunder
(including with respect to Good Clinical Practices, Good Laboratory Practices
and Good Manufacturing Practices, in each case to the extent applicable), and
equivalent applicable Laws of other Governmental Authorities; (b) the
reimbursement and payment for health care products and services, including any
United States federal health care program (as such term is defined in 42 U.S.C.
§ 1320a-7b(f)), and programs and arrangements pertaining to providers of health
care products or services that are paid for by any Governmental Authority or
other Person, including the federal Anti-Kickback Statute (42 U.S.C. §
1320a-7b(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.), the
administrative False Claims Law (42 U.S.C. § 1320a-7b(a)), 42 U.S.C. § 1320a-7
and 42 U.S.C. § 1320a-7a, and the regulations promulgated pursuant to such
statutes, Medicare (Title XVIII of the Social Security Act) and the regulations
promulgated thereunder, Medicaid (Title XIX of the Social Security Act) and the
regulations promulgated thereunder, and equivalent applicable Laws of other
Governmental Authorities; (c) the privacy and security of patient-identifying
information, including, without limitation, the Health Insurance Portability and
Accountability Act of 1996 (42 U.S.C. § 1320d et seq.) and the regulations
promulgated thereunder and equivalent applicable Laws of other Governmental
Authorities; (d) to the extent required, registration and reporting of clinical
trials in accordance with 42 U.S.C. § 282(j) in each of the foregoing (a)
through (d), as may be amended from time to time and (e) state health care laws
including those corresponding to the federal laws described in (a) through (d).

 

“HHS” has the meaning set forth in the recitals.

 

“Initial Term” has the meaning set forth in Section 18.1(a).

 

“Insurance Policies” has the meaning set forth in Section 14.6.

 

“Intellectual Property” means all intellectual property, intangible property and
proprietary rights, title, interests and protections, however arising, pursuant
to the Laws of any jurisdiction throughout the world, including all United
States, foreign and international: (a) inventions (whether or not patentable),
patents, patent applications and statutory invention registrations, utility
models, reissues, divisionals, continuations, continuations-in-part, extensions
and reexaminations thereof; (b) trademarks, service marks, trade dress, logos,
trade names and corporate names, uniform resource locator addresses, symbols,
slogans, and other indicia of source or origin, including the goodwill of the
business symbolized thereby or associated therewith, common law rights,
registrations and applications thereof; (c) internet domain names, website
content, social media handles, tags, hashtags, social media accounts, or any
other online indicia of source; (d) original works of authorship in any medium
of expression (whether or not published), copyrights and copyrightable works,
registrations and applications for registration of such copyrights, and all
issuances, extensions and renewals of such registrations and applications; (e)
trade secrets, formulas, designs, devices, technical data, technology, know-how,
research and development, advertising and promotional materials, inventions and
invention disclosures, methods or processes, and other confidential or
proprietary technical, business and other information; (f) computer software
(including source and object code) and computer programs and databases in any
form, including firmware, development tools, algorithms, data, data files,
records, database management code, utilities, graphic user interfaces, internet
web sites, all versions, updates, corrections, enhancements and modifications of
any of the foregoing, and all related documentation; (g) all rights and remedies
against past, present and future infringement, misappropriation or any other
violations relating to any of the foregoing; and (h) all tangible embodiments of
any of the foregoing.

 

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“ISMMS” means Icahn School of Medicine at Mount Sinai, a New York educational
corporation.

 

“ISMMS IP License Agreement” means that certain License and Collaboration
Agreement entered into by and between ISMMS and Sponsor, dated as of May 4,
2020, pursuant to which ISMMS grants to Sponsor a non-exclusive license to use
certain Intellectual Property related to the MS Lab Test, including the MS
Background IP, for the purposes contemplated by this Agreement.

 

“ISMMS License Agreements” means the ISMMS IP License Agreement and the ISMMS TM
License Agreement.

 

“ISMMS TM License Agreement” means that certain Trademark License Agreement
entered into by and between ISMMS and Sponsor, dated as of May 4, 2020, pursuant
to which ISMMS grants to Sponsor a non-exclusive license to use the Sponsor
Licensed Marks for the purposes contemplated by this Agreement and as permitted
by Section 6.3.

 

“ISO 13485:2016 Quality System Standards” means (i) the standards for a quality
management system for medical devices established by the International
Organization for Standards designated as ISO 13485:2016 by such organization, as
the same may have been amended as of the time of any reference thereto and (ii)
any corresponding standards imposed by any applicable End User-Specific
Requirements.

 

“IVD” means in vitro diagnostic product as that term is defined in 21 C.F.R. §
809.3(a) and used by the FDA in its regulations, guidance, and procedures.

 

“Jointly Developed Intellectual Property” has the meaning set forth in Section
3.3(c).

 

“Jointly Owned Patents” means (a) the United States and foreign patents and/or
patent applications relating to the Co-Developed Tests; (b) any and all patents
issuing from the foregoing; (c) any and all claims of continuation-in-part
applications that claim priority to the United States patent applications, in
the case of each of (a), (b) and (c) to the extent relating to the Jointly
Developed Intellectual Property, but only where such claims are directed to
inventions disclosed in the manner provided in the first paragraph of 35 U.S.C.
§ 112 in such United States patent applications, and such claims in any patents
issuing from such continuation-in-part applications; (d) any and all foreign
patent applications, foreign patents, or related foreign patent documents that
claim priority to the patents and/or patent applications relating to the Jointly
Developed Intellectual Property; and (e) any and all divisionals, continuations,
reissues, re-examinations, renewals, substitutions, and extensions of the
foregoing.

 

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“Laws” means all active governmental constitutions, laws, statutes, ordinances,
treaties, rules, common laws, rulings, regulations, orders, charges, directives,
determinations, executive orders, writs, judgments, injunctions, decrees,
restrictions or similar legally effective pronouncements of any Governmental
Authority, including, without limiting the generality of the foregoing, Health
Care Laws.

 

“Licensed Use” means for Bio-Techne to brand the Co-Developed Test Kits with the
Sponsor Licensed Marks in accordance with the requirements of Section 6.2 and
the other terms and conditions of this Agreement and for the Parties to market,
promote, distribute and/or sell the Co-Developed Test Kits under this Agreement.

 

“Losses” means out-of-pocket losses, damages, liabilities, deficiencies,
Actions, judgments, interest, awards, penalties, fines, Taxes, costs or expenses
of whatever kind, including reasonable fees of accountants, attorneys and other
similar professionals, the cost of enforcing any right to indemnification
hereunder, and the cost of pursuing any insurance providers.

 

“Manufacturing” means all activities directed to sourcing of necessary Raw
Materials, producing, processing, packaging, labeling, quality assurance
testing, release of the Co-Developed Test Kits, whether for Development or
Commercialization, in each case as responsibility for each such activity is
allocated between Sponsor and Bio-Techne in accordance with this Agreement. When
used as a verb, “Manufacture” means to engage in Manufacturing.

 

“Manufacturing Milestones” has the meaning set forth in Section 5.2(a).

 

“Marks” means and all trademarks whether registered or unregistered, trademark
registrations, trademark applications, service marks whether registered or
unregistered, service mark registrations and service mark applications, brand
names, corporate names, trade names, logos, designs, slogans, trade dress,
domain names, social media handles and user names, and other proprietary indicia
of goods and services, and all registrations and applications for registration
of the foregoing, all issuances, extensions and renewals of such registrations
and applications, and all goodwill associated with any of the foregoing, of
Mount Sinai Health System, Inc.  or any of the other Mount Sinai Entities and
any derivative, translation, transliteration, or adaptation thereof, including,
without limitation, the Sponsor Licensed Marks.

 

“Materials” means the tangible physical material, if any, delivered to
Bio-Techne under this Agreement, and any progeny, derivatives, or improvements
thereof developed by Bio-Techne or its Affiliates.

 

“Material Transfer Agreement” means that certain Material Transfer Agreement
effective as of April 15, 2020, by and between ISMMS and Bio-Techne, as the same
may be amended from time to time.

 

“MS Background IP” means all Intellectual Property of the Mount Sinai Entities
embodying the MS Lab Test (and any improvements thereto made by ISMMS and/or any
Affiliates of ISMMS to the extent that Bio-Techne has not contributed to such
improvements) utilizing a 96-well plate ELISA technology, including without
limitation, the Intellectual Property described in the “Authorized Product
Details” set forth in the MS Lab Test EUA and the document entitled “Accelerated
Emergency Use Authorization (EUA) Summary COVID-19 ELISA IgG Antibody Test
(Mount Sinai Laboratory)” submitted by the MS Lab in connection with the
obtaining of the MS Lab Test EUA and any future versions of the MS Lab Test that
are developed by ISMMS and/or Affiliates of ISMMS to the extent that Bio-Techne
has not contributed to such future versions, utilizing a 96-well plate ELISA
technology. MS Background IP shall not include Bio-Techne Background IP or
Jointly Developed Intellectual Property.

 

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“MS Lab” means the Mount Sinai Laboratory, Center for Clinical Laboratories, a
division of the Department of Pathology, Molecular, and Cell-Based Medicine, New
York, New York that is certified as a CLIA HC Lab.

 

“MS Lab Test” means the qualitative test for the detection of IgG antibodies
against SARS-CoV-2 in serum and plasma specimens collected from individuals
suspected of prior infection with the virus that causes COVID-19 by their
healthcare provider as described in the MS Lab Test EUA.

 

“MS Lab Test EUA” means the EUA issued by the FDA to the MS Lab on April 15,
2020, with respect to the use of the MS Lab Test in the MS Lab, subject to the
terms and conditions of such EUA.

 

“Mount Sinai Entities” means Mount Sinai Health System, Inc. and the Affiliates
of Mount Sinai Health System, Inc., including, without limitation, The Mount
Sinai Hospital, Beth Israel Medical Center, St. Luke’s-Roosevelt Hospital
Center, The New York Eye and Ear Infirmary, South Nassau Communities Hospital
and ISMMS.

 

“Notice” has the meaning set forth in Section 19.5.

 

“Notice Address” has the meaning set forth in Section 19.5.

 

“Order” means any order, writ, judgment, injunction, decree, stipulation,
determination or award entered by or with any Governmental Authority but not
including Permits.

 

“Original Components” means the Raw Material, substance, piece, part, software,
firmware, labeling, or assembly or any other component of the Co-Developed Lab
Test specified in the application for EUA, 510(k) clearance or de novo
classification therefor, or the application submitted to any other applicable
Regulatory Authority.

 

“Outside Date” means September 30, 2020.

 

“Part 820” means the regulations of the FDA at 21 C.F.R. Part 820, as the same
may have been amended at the time of any reference thereto.

 

“Part 820 Compliance Protocol” has the meaning set forth in Section 9.3(b).

 

“Party” means (a) the Sponsor or any successor or permitted assign thereof or
(b) Bio-Techne or any successor or permitted assign thereof.

 

“Permits” means all permits, licenses, franchises, clearances, approvals,
authorizations, registrations, certificates, variances and similar rights
obtained, or required to be obtained, from Governmental Authorities.

 

“Permitted Use” has the meaning set forth in Section 3.2(a).

 

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“Person” means a corporation, an association, a joint venture, a partnership, a
trust, a business, an institution, an individual, a government or political
subdivision thereof, including an agency, or any other organization that can
exercise independent legal standing.

 

“Phase I” has the meaning set forth in Section 3.1(a).

 

“Phase II” has the meaning set forth in Section 5.1(a).

 

“Portal” has the meaning set forth in Section 8.6.

 

“Product” means a finished component, for example, a reagent or device.

 

“Prosecution” means the filing, preparation, prosecution (including any
interferences, reissue proceedings, reexaminations, and oppositions), extension,
term adjustment, and maintenance of any patents.  When used as a verb,
“Prosecute” means to engage in Prosecution.

 

“Public Health Emergency” has the meaning set forth in the recitals.

 

“Quality Agreement” means the separate quality agreement, dated as of the date
hereof, being executed by Sponsor and Bio-Techne in connection with this
Agreement.

 

“Raw Materials” means the excipients, chemicals, processing aids necessary for
processing or manufacture of Components or Products per specification.

 

“real time” for purposes of this Agreement does not mean that the applicable
data or information is provided on an instantaneous basis but rather means that
the applicable data or information is provided on a basis that is updated no
less frequently than daily or as mutually agreed.

 

“Regulatory Approval” means, with respect to a country or other jurisdiction,
all approvals, licenses, clearances, de novo classification request decisions,
marks, registrations, authorizations certificates, exemptions, consents,
franchises, concessions, notices or other like item of or issued by any
Governmental Authority, from the relevant Governmental Authority necessary or
useful to commercially distribute, sell or market the Co-Developed Test Kits in
such country or other applicable jurisdiction (not including any applicable
pricing and governmental reimbursement approvals unless legally required to
market the Co-Developed Test Kits in a country or other applicable
jurisdiction).

 

“Regulatory Authorities” means any applicable Governmental Authority involved in
granting Regulatory Approval for, and responsible for the regulation of, the
Co-Developed Test Kits in any Jurisdiction, including the FDA, EMA, or such
other state or foreign country equivalent Governmental Authority as applicable. 

 

“Renewal Term” has the meaning set forth in Section 18.1(b).

 

“Research Use Only” or “RUO” has the meaning ascribed to the term “research use
only” as defined in 21 C.F.R. § 809.10(c)(2)(i) and used by the FDA in its
applicable regulations and guidance as of the time of any reference thereto.

 

“RUO Addendum” has the meaning set forth in Section 11.1.

 

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“SARS-CoV-2” has the meaning set forth in the recitals.

 

“Specification” means any requirement with which a product, process, service, or
other activity must conform.

 

“Sponsor” means Kantaro Biosciences LLC, a Delaware limited liability company.

 

“Sponsor Indemnitees” has the meaning set forth in Section 17(a).

 

“Sponsor Licensed Marks” has the meaning set forth in Section 6.3(a).

 

“Sponsor Patent Option” has the meaning set forth in Section 3.3(c)(ii)(1).

 

“Steering Committee” has the meaning set forth in Section 2.1(a).

 

“Term” has the meaning set forth in Section 18.1(b).

 

“Transaction Documents” means this Agreement, the Material Transfer Agreement,
the Bio-Techne NDA, and such other agreements, instruments and documents as the
Parties may enter into from time to time in connection with the transactions
contemplated by this Agreement.

 

“Working Group” has the meaning set forth in Section 2.1(e).

 

“Validation” means a documented program that provides a high degree of assurance
that a specific process, method, or system will consistently produce results
meeting predetermined acceptance criteria.

 

2.

GOVERNANCE

 

2.1     Steering Committee

 

(a)     Establishment of Steering Committee. The Parties share a common
objective of collaborating to enable the development of the Co-Developed Test
Kit, obtaining EUA authorization to distribute and sell Co-Developed Test Kits
(and, subject to the terms and conditions herein, obtaining a 510(k) clearance,
de novo classification, or approval, as applicable) and, subject to the terms
and conditions set forth herein, distributing and selling Co-Developed Test Kits
in accordance with applicable Laws in a manner that most rapidly and effectively
supports societal efforts to respond to the Public Health Emergency and advances
public health. The Parties recognize that to do so will require the Parties to
build into their relationship sufficient flexibility to respond to rapidly
changing circumstances without compromising the Parties’ commitment to
compliance with Law and appropriate risk management. Therefore, the Parties
hereby establish a committee (the “Steering Committee”) to support the Parties
efforts to achieve their common objective.

 

(b)     Authority of Steering Committee. The Steering Committee shall have the
specific authorities ascribed to it in this Agreement. The Steering Committee
shall also serve as a forum in which the Parties shall discuss any evolution in
the terms of this Agreement that either Party believes is necessary, any matters
affecting the Parties’ performance hereunder that were not foreseen as of the
Effective Date, and any differences that may arise between the Parties. The
Steering Committee shall not have any authority that is not expressly provided
for in this Agreement.

 

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(c)     Composition and Requirements for Steering Committee Action. The Steering
Committee shall be composed of an equal number of appointees of each Party. The
initial appointees of each Party are listed on Schedule 2.1(c). Either Party may
change any of its appointees to the Steering Committee, provided that such Party
gives the other Party two (2) days’ prior Notice and the Designated Executive of
the Party receiving such Notice approves the change in the requesting Party’s
appointee(s) (such approval not to be unreasonably withheld). The Steering
Committee may meet in person or by telephonic or electronic means. In order for
the Steering Committee to act, the unanimous vote of all members of the Steering
Committee appointed by each Party shall be required.

 

(d)     Establishment of Subcommittees of the Steering Committee. The Steering
Committee may establish subcommittees to assist the Steering Committee in the
fulfillment of its role under this Agreement, provided that no subcommittee of
the Steering Committee shall have any authority that the Steering Committee does
not itself have. The Steering Committee shall establish a written charter for
each subcommittee established by the Steering Committee. Members of any
subcommittee established by the Steering Committee need not be members of the
Steering Committee. Unless the Steering Committee determines otherwise with
respect to any given subcommittee, (i) each subcommittee shall be composed of an
equal number of appointees of each Party and either Party may change any of its
appointee to a subcommittee by notice given to the other Party, and (ii) in
order for a subcommittee to act, the vote of a majority of all members of the
subcommittee shall be required. Each subcommittee may meet in person or by
telephonic or electronic means. If the vote of a majority of all members of a
subcommittee is not able to be obtained as to any matter, the matter will be
referred to the Steering Committee for resolution.

 

(e)     Establishment of Working Groups. The Steering Committee or any
subcommittee may establish one or more working groups composed of individuals
with specific subject matter expertise (each a “Working Group”) in order to
assist the Steering Committee or any subcommittee in considering or developing
approaches to or recommendations with respect to specific categories of work
under this Agreement, provided that no Working Group shall have any authority
that the Steering Committee or the subcommittee does not itself have. The
Steering Committee or applicable subcommittee shall establish a written charter
for each Working Group established by the Steering Committee or subcommittee. A
Working Group may be established and have responsibilities relating to a
discrete project, or may be established on a temporary basis. Members of any
Working Group need not be members of the Steering Committee or any subcommittee.
Unless the Steering Committee or subcommittee determines otherwise with respect
to any given Working Group, (i) each Working Group shall be composed of subject
matter expert appointees of each Party and either Party may change any of its
appointee to a Working Group by notice given to the other Party, and (ii) the
Working Group members are expected to make a written recommendation to the
Steering Committee and any dissent within the group can be so noted. Each
Working Group may meet in person or by telephonic or electronic means. The
initial Working Groups are listed on Schedule 2.1(e).

 

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2.2     Designated Executives

 

(a)     Reference to Designated Executives. The Parties acknowledge that there
may be matters that come before the Steering Committee that the Steering
Committee is not able to resolve. The Steering Committee shall have the
authority to refer any such matter to two senior executives (the “Designated
Executives”), one appointed by each Party. Each Party agrees to appoint as its
Designated Executive only a senior executive with the standing and authority
within the organizational structure of such Party to be able to deal with and
resolve matters referred to the Designated Executives by the Steering Committee.
The initial Designated Executives are listed on Schedule 2.1(c). The Designated
Executives shall not have the authority to determine matters that are not within
the authority of the Steering Committee. However, the Designated Executives
shall have the authority to recommend to the Parties amendments to this
Agreement that the Designated Executives believe should be made.

 

(b)     Requirements for Designated Executives’ Action. The Designated
Executives may meet in person or by telephonic or electronic means. In order for
the Designated Executives to act the unanimous vote of both Designated
Executives shall be required, provided that if a unanimous vote of both
Designated Executives is not able to be obtained in respect of any matter, the
determination of the Designated Executive appointed by Sponsor as the
manufacturer of record of the Co-Developed Test Kits shall be deemed to be the
determination of the Designated Executives.

 

3.

DEVELOPMENT OF CO-DEVELOPED TEST

 

3.1     Development Process for Co-Developed Test.

 

(a)     Bio-Techne Development Responsibilities. During the period (“Phase I”)
between the Effective Date and the date on which EUA is obtained for the
Co-Developed Test Kit, Bio-Techne shall devote appropriate resources to (i) the
Development of a Co-Developed Test that (A) is based on the MS Lab Test, (B)
meets the specifications and has the performance characteristics set forth on
Schedule 3.1(a), (C) is able to be Manufactured and Commercialized in quantities
that meet the Manufacturing Milestones, (D) complies with Law and any End
User-Specific Requirements and has the necessary attributes to be granted EUA
and (E) is accepted by Sponsor as meeting the requirements of this Agreement and
(ii) the Development of a prototype of the Co-Developed Test Kit that can be
used for the purposes of obtaining EUA for the Co-Developed Test Kit and that
has been accepted by Sponsor as meeting the requirements of this Agreement.
Subject to contractual commitments existing prior to April 17, 2020 and subject
to any contrary requirements of Law, during Phase I Bio-Techne shall not
prioritize any other project over the Development of a Co-Developed Test.

 

(b)     Sponsor Development Responsibilities. To the extent not provided by
ISMMS prior to the Effective Date, during Phase I, Sponsor shall (i) promptly
provide all information that Bio-Techne requests in connection with the MS
Background IP licensed to Bio-Techne hereunder, (ii) promptly cooperate with
Bio-Techne in Bio-Techne’s efforts to Develop the Co-Developed Test and (iii)
comply with the Material Transfer Agreement and use reasonable commercial
efforts to facilitate Bio-Techne’s access to sources of supply for the
development of the Co-Developed Test.

 

(c)     Sponsor Acceptance of Co-Developed Test and Test Kit. The determination
that a test satisfies the criteria of this Agreement to constitute a
Co-Developed Test and that a prototype of a Co-Developed Test Kit is ready to be
submitted for EUA shall be made by Sponsor. Sponsor may undertake such
Validation processes as Sponsor may determine are necessary or appropriate in
connection with such determination, and Bio-Techne shall cooperate in any such
processes. Sponsor shall use reasonable commercial efforts to complete such
processes as promptly as is feasible.

 

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3.2     License Grant with Respect to MS Background IP.

 

(a)     License Grant to MS Background IP. Subject to the terms and conditions
of this Agreement, Sponsor hereby grants Bio-Techne a non-exclusive,
non-sublicensable, and non-transferable license to use the MS Background IP (i)
during the Term, solely for the purpose of Developing the Co-Developed Test and
Developing, Manufacturing and Commercializing the Co-Developed Test Kits in
accordance with this Agreement, (ii) during the Term, solely to the extent the
Co-Developed Test Kits are contemplated to be sold pursuant to the RUO Addendum,
and (iii) after the Term in connection with Bio-Techne’s exploitation of Jointly
Developed Intellectual Property provided that the Parties and ISMMS shall first
have agreed, each in its own discretion, upon the economic terms of such license
and exploitation (including in respect of any appropriate revenue share or other
compensation payable to Sponsor in respect of such sublicense) (the uses
described in (i), (ii) and (iiii), the “Permitted Use”).

 

(b)     Use Restrictions. Bio-Techne shall only use the MS Background IP for the
Permitted Use and shall not disclose, release, distribute, or deliver the MS
Background IP, or any portion thereof, to any other Person without Sponsor’s
prior written consent. Any purpose or use not specifically authorized herein is
prohibited unless otherwise agreed to in writing by Sponsor.

 

(c)     Delivery. To the extent not delivered by ISMMS prior to the Effective
Date, Sponsor shall deliver the MS Background IP electronically, on tangible
media, or by other means to Bio-Techne promptly following the Effective Date.

 

(d)     Confidentiality. The MS Background IP shall constitute Confidential
Information of Sponsor and shall be subject to the requirements of the
Bio-Techne NDA.

 

3.3     License Grant; Intellectual Property Ownership; Jointly Developed
Intellectual Property.

 

(a)     Rights to MS Background IP. Bio-Techne acknowledges that all MS
Background IP is and shall remain the sole property of ISMMS. Except for the
limited rights and licenses expressly granted under this Agreement, nothing in
this Agreement grants, by implication, waiver, estoppel, or otherwise, to
Bio-Techne or any third party any Intellectual Property rights or other right,
title or interest in or to the MS Background IP.

 

(b)     Rights to Bio-Techne Background IP. Sponsor acknowledges that all
Bio-Techne Background IP is and shall remain the sole property of Bio-Techne.
Except for the limited rights and licenses expressly granted under this
Agreement, nothing in this Agreement grants, by implication, waiver, estoppel,
or otherwise, to Sponsor or any third party any Intellectual Property rights or
other right, title or interest in or to the Bio-Techne Background IP.

 

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(c)     Jointly Developed Intellectual Property Relating to the Co-Developed
Test.

 

(i)     Ownership of Jointly Developed Intellectual Property. Each Party shall
own an equal and undivided interest in (1) such Intellectual Property as does
not constitute MS Background IP or Bio-Techne Background IP and as is discovered
or created in the course of the Development of the Co-Developed Test and/or the
Co-Developed Test Kits and (2) any related information, developments,
improvements, and Intellectual Property as is jointly developed by the Parties
in connection with the Manufacture and/or Commercialization of the Co-Developed
Test Kits (the Intellectual Property, information, developments and improvements
described in clause (1) and (2) of this sentence, the “Jointly Developed
Intellectual Property”). Bio-Techne acknowledges that Sponsor has the right to
enter into an agreement with ISMMS granting to ISMMS a perpetual, worldwide,
royalty-free license to use the Jointly Developed Intellectual Property to the
same extent that Sponsor itself would have the right to use the Jointly
Developed Intellectual Property, provided that any such agreement expressly
provides that Bio-Techne is a third party beneficiary of and is entitled to
enforce the obligations of ISMMS thereunder to observe and adhere to the
restrictions and limitations on the use of Jointly Developed Intellectual
Property that are imposed on Sponsor by this Agreement and that Sponsor has
provided to Bio-Techne a copy of such agreement.

 

(ii)     Right to Prosecute Jointly Owned Patents.

 

(1)     Sponsor shall have the first right, but shall not be obligated, to
Prosecute any and all Jointly Owned Patents (the “Sponsor Patent Option”). If
Sponsor exercises the Sponsor Patent Option, Sponsor will, in consultation with
Bio-Techne, Prosecute the Jointly Owned Patents in the joint names of the
Parties, and shall pay all expenses for Prosecuting the Jointly Owned Patents,
including without limitation, any taxes, annuities or maintenance fees on such
Jointly Owned Patents.

 

(2)     If at any time Sponsor has not exercised the Sponsor Patent Option with
respect to a particular discovery that is part of the Jointly Developed
Intellectual Property, and Bio-Techne wishes to Prosecute a Jointly Owned Patent
with respect to such discovery, Bio-Techne shall consult with Sponsor regarding
whether Sponsor wishes to Prosecute such Jointly Owned Patent, and if Sponsor
declines to Prosecute such Jointly Owned Patent, then Bio-Techne shall have the
right, in consultation with Sponsor, to Prosecute such Jointly Owned Patent in
the joint names of the Parties, and Bio-Techne shall pay all expenses for
Prosecuting such Jointly Owned Patent, including without limitation, any taxes,
annuities or maintenance fees on such Jointly Owned Patent.

 

(3)     If at any time either Party indicates to the other Party by written
notice that it no longer desires to Prosecute any Jointly Owned Patent(s), the
other Party may take over the rights of such Party with respect to the
applicable Jointly Owned Patent, and shall pay all expenses for Prosecuting such
Jointly Owned Patent(s), including without limitation, any taxes, annuities or
maintenance fees on such Jointly Owned Patent(s).

 

(iii)     Exploitation of Patent Rights. Each Party shall be entitled, on a
royalty-free basis, to use the Jointly Owned Patent(s) for any purpose permitted
by Law. Subject to the approval of the other Party, each Party shall have the
right to grant license(s) under the Jointly Owned Patents to any third-party
subject to mutual agreement on the applicable economic terms (including in
respect of any appropriate revenue share or other compensation payable to each
Party in respect of such license) of such license; provided, however, Bio-Techne
agrees that Sponsor shall have the right to license any Jointly Owned Patents to
ISMMS for research and education purposes for no consideration without the prior
approval of Bio-Techne.

 

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(iv)     Cooperation of Parties. The Parties agree to cooperate fully with each
other to provide any information or documentation necessary to support the
Prosecution of a Jointly Owned Patent and each Party Prosecuting a Jointly Owned
Patent shall provide such information regarding such Prosecution as the other
Party shall reasonably request.

 

(v)     Limited License to Bio-Techne Background IP. Sponsor is hereby granted a
non-exclusive, perpetual, worldwide, royalty-free paid-up license to use the
Bio-Techne Background IP during and after the Term solely for the purpose of (A)
using the Co-Developed Test and any modifications thereof and all Jointly
Developed Intellectual Property for patient care, education and/or research
purposes, (B) performing the obligations of Sponsor under this Agreement and
applicable Law, and (C) subject to Section 3.4(a), Developing, Manufacturing and
Commercializing serologic tests that have the same or similar functions as the
Co-Developed Test Kits. Bio-Techne acknowledges that Sponsor has the right to
enter into an agreement with ISMMS granting to ISMMS a perpetual, worldwide,
royalty-free license to use the Bio-Techne Background IP to the same extent that
Sponsor itself would have the right to use the Bio-Techne Background IP,
provided that any such agreement expressly provides that Bio-Techne is a third
party beneficiary of and is entitled to enforce the obligations of ISMMS
thereunder to observe and adhere to the restrictions and limitations on the use
of the Bio-Techne Background IP that are imposed on Sponsor by this Agreement
and that Sponsor has provided to Bio-Techne a copy of such agreement.

 

3.4     Rights to Sublicense.

 

(a)     Sublicensing Rights of Sponsor. Other than the Bio-Techne Background IP,
Sponsor shall have the right to freely sublicense any Intellectual Property in
which Sponsor has rights hereunder, provided that it shall be a condition of the
right of Sponsor to sublicense Jointly Developed Intellectual Property that the
Parties shall first have agreed, each in its own discretion, upon the economic
terms of such sublicense (including in respect of any appropriate revenue share
or other compensation payable to Bio-Techne in respect of such sublicense);
provided, however, Bio-Techne agrees that Sponsor shall have the right to
license any Jointly Developed Intellectual Property to ISMMS for research and
education purposes for no consideration without the prior approval of
Bio-Techne. For the avoidance of doubt, Sponsor shall not have the right to
sublicense Bio-Techne Background IP except as expressly provided in Section
3.3(c)(v).

 

(b)     Sublicensing Rights of Bio-Techne. Other than the MS Background IP,
Bio-Techne shall have the right to freely sublicense any Intellectual Property
in which Bio-Techne has rights hereunder, provided that it shall be a condition
of the right of Bio-Techne to sublicense Jointly Developed Intellectual Property
that the Parties shall first have agreed, each in its own discretion, upon the
economic terms of such sublicense (including in respect of any appropriate
revenue share or other compensation payable to Sponsor in respect of such
sublicense). For the avoidance of doubt, Bio-Techne shall not have the right to
sublicense MS Background IP.

 

3.5     Escrow of Bio-Techne Background IP. Within ninety (90) days after the
date on which Sponsor confirms pursuant to Section 3.1(a) that it accepts the
Co-Developed Test Kit as meeting the specifications and having the performance
characteristics set forth on Schedule 3.1(a), the Parties shall negotiate in
good faith an escrow of appropriate tangible materials describing the Bio-Techne
Background IP that is necessary or useful for the Manufacture of the
Co-Developed Test Kit that would be sufficient for Sponsor to utilize such
Bio-Techne Background IP for the purposes contemplated by Section 18.2(d) in the
event of a termination of this Agreement by Sponsor pursuant to Section
18.1(c)(i). To the extent that any such escrow requires a third party to hold
tangible materials on behalf of Sponsor and Bio-Techne, Sponsor shall pay the
fees of such third party.

 

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4.

FDA REGULATORY PROCESS

 

4.1     FDA Regulatory Process Prior to EUA Issuance.

 

(a)     Responsibilities of Sponsor in Respect of EUA. Commencing no later than
the date on which Sponsor accepts a Co-Developed Test and a prototype
Co-Developed Test Kit pursuant to Section 3.1(a) and Section 3.1(c), Sponsor
shall use all reasonable commercial efforts to obtain EUA for the Co-Developed
Test Kit and shall pay all expenses relating to obtaining EUA for the
Co-Developed Test Kits. Sponsor shall keep Bio-Techne reasonably informed of the
process of applying for EUA in respect of the Co-Developed Test, and shall
provide Bio-Techne with copies of any correspondence between Sponsor and the FDA
with respect to the application for EUA in respect of the Co-Developed Test Kit
reasonably promptly after such correspondence is received by Sponsor. Promptly
upon obtaining EUA for the Co-Developed Test Kit, Sponsor shall notify
Bio-Techne of such EUA and shall provide Bio-Techne with a copy of such EUA.

 

(b)     Responsibilities of Bio-Techne. Bio-Techne shall promptly provide to
Sponsor such information, data and materials as Sponsor reasonably requests in
order to obtain EUA in respect of the Co-Developed Test Kit.

 

(c)     No Other Responsibility to Seek Approvals of Government Authorities.
Unless and until EUA is obtained in respect of a Co-Developed Test Kit, Sponsor
shall have no obligation to seek 510(k) clearance, review of a de novo
classification request, premarket approval (PMA), or any other type of required
premarket review and authorization from the FDA of a Co-Developed Test Kit as an
IVD or to seek or obtain any approval or clearance of any Governmental Authority
for the Commercialization of a Co-Developed Test Kit in any country other than
the United States. To the extent that Sponsor elects to undertake any such
process or seek any such clearance, required premarket review and authorization,
Bio-Techne shall promptly provide to Sponsor such information, data and
materials as Sponsor reasonably requests in connection therewith.

 

4.2     FDA Regulatory Process After EUA Issuance.

 

(a)     Responsibilities of Sponsor After Issuance of EUA. Commencing no later
than the date on which EUA is issued by the FDA in respect of a Co-Developed
Test Kit and thereafter during the Term, Sponsor shall (i) seek 510(k)
clearance, review of a de novo classification request, or other applicable type
of required premarket review and authorization by the FDA of the Co-Developed
Test Kit as an IVD and (ii) in such order and with such priorities as are
determined by the Steering Committee, use reasonable commercial efforts to
obtain the approval or clearance of the applicable Governmental Authorities in
countries other than the United States for the Commercialization of a
Co-Developed Test Kit in such countries. Sponsor shall keep Bio-Techne
reasonably informed of the processes described in this Section 4.2(a). The
Steering Committee shall have the authority to suspend or terminate the process
of obtaining 510(k) clearance, review of a de novo classification request, or
other applicable type of required premarket review and authorization by the FDA
of the Co-Developed Test Kit and/or the process of obtaining the approval or
clearance of the applicable Governmental Authorities in countries other than the
United States for the Commercialization of a Co-Developed Test Kit in such
countries, in each case to the extent the Steering Committee determines that
market, regulatory or other conditions make such suspension or termination
appropriate (and any difference of views in the Steering Committee with respect
to such matters shall be resolved through the Escalation Process). Promptly upon
obtaining clearance, de novo classification, or approval, as applicable, by the
FDA of the Co-Developed Test Kit as an IVD, Sponsor shall notify Bio-Techne of
such clearance, de novo classification, or approval and shall provide Bio-Techne
with a copy of such clearance, de novo classification, or approval. Promptly
upon obtaining the approval or clearance of an applicable Governmental Authority
in a country other than the United States for the Commercialization of a
Co-Developed Test Kit in such country, Sponsor shall notify Bio-Techne of such
approval or clearance and shall provide Bio-Techne with a copy of such approval.

 

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(b)     Responsibilities of Bio-Techne After Issuance of EUA. Bio-Techne shall
promptly provide to Sponsor such information, data and materials as Sponsor
reasonably requests in order to obtain clearance, de novo classification, or
approval by the FDA of the Co-Developed Test Kit as an IVD and/or to obtain the
approval or clearance of an applicable Governmental Authority in a country other
than the United States for the Commercialization of a Co-Developed Test Kit in
such country.

 

5.

MANUFACTURING OBLIGATIONS; MILESTONES

 

5.1     Manufacturing of Co-Developed Test Kits. 

 

(a)     Responsibilities of Bio-Techne. Subject to the terms and conditions of
this Agreement, and without purporting to limit the legal responsibility of
Sponsor as the manufacturer of record of the Co-Developed Test, commencing no
later than the date on which EUA is obtained in respect of a Co-Developed Test
Kit and thereafter throughout the Term (such being referred to as “Phase II”),
as between Sponsor and Bio-Techne, Bio-Techne shall be responsible for the
Manufacturing of the Co-Developed Test Kits in accordance with applicable Law
and any End User-Specific Requirements; provided, however, Sponsor shall retain
the oversight responsibilities provided for in Section 9 and all other
applicable provisions of this Agreement. Without limiting the legal
responsibility of Sponsor as the manufacturer of record of the Co-Developed
Test, in the course of Manufacturing Co-Developed Test Kits, Bio-Techne shall
observe, adhere to and comply with all obligations in relation to Manufacturing
of the Co-Developed Test Kits that are imposed on Sponsor as the holder of the
EUA in respect thereof (including without limitation the quality and compliance
obligations described in Section 9) and any applicable End User-Specific
Requirements. In the Manufacturing process, Bio-Techne shall not Deviate from
the specifications set forth on Schedule 3.1(a) unless such Deviation is
approved in writing by Sponsor in its sole discretion. Without limiting the
legal responsibility of Sponsor as the manufacturer of record of the
Co-Developed Test, as between Sponsor and Bio-Techne, Bio-Techne agrees that it
shall be solely responsible for such obligations and that Sponsor shall have no
obligations to Bio-Techne in respect thereof except as is expressly set forth in
Section 5.1(b). In the event the Parties mutually determine to jointly engage a
third party to provide increased Manufacturing capacity, the Parties shall do so
only on mutually agreeable terms with each other, as well as with the selected
third party manufacturer.

 

(b)     Responsibilities of Sponsor. Sponsor shall promptly provide to
Bio-Techne such information as Bio-Techne reasonably requests in connection with
Bio-Techne’s discharge of its responsibilities under Section 5.1(a) and as
Sponsor can obtain without unreasonable effort or expense. Upon Sponsor’s
receipt of any communication from any Governmental Authority or any End User
that relates to or may affect the process of Manufacturing the Co-Developed Test
Kits, Sponsor shall promptly provide a copy of such communication to Bio-Techne.
Sponsor shall also retain the oversight responsibilities provided for in Section
9 and other applicable provisions of this Agreement.

 

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5.2     Manufacturing Milestones.

 

(a)     Establishment and Achievement of Manufacturing Milestones. Subject to
the terms and conditions of this Agreement and to any requirements of applicable
Law, and subject to contractual commitments existing prior to April 17, 2020, to
the extent necessary to satisfy demand for the Co-Developed Test Kits as of any
applicable date, Bio-Techne shall prioritize the Manufacturing of the
Co-Developed Test Kits over any other business arrangement of Bio-Techne in
accordance with this Agreement in such volumes as to achieve the milestones (the
“Manufacturing Milestones”) set forth on Schedule 5.2(a).

 

(b)     Modification of Manufacturing Milestones and Resolution of Differences
with Respect Thereto. The Steering Committee shall have the authority to modify
the Manufacturing Milestones. Any differences as to whether the Manufacturing
Milestones should be modified shall be resolved through the Escalation Process.

 

5.3     Product Warranty. A Working Group shall be established to develop, prior
to the first sale of a Co-Developed Test to an End User, the product warranty in
respect of the Co-Developed Test Kits, taking into account the labelling insert
in the Co-Developed Test Kits and the Certificate of Analysis in respect of the
Co-Developed Test Kits. The Steering Committee shall have the authority to
approve the product warranty, and once approved to modify the product warranty.
Any differences as to whether the product warranty should be modified shall be
resolved through the Escalation Process. As of the date of any shipment of a
Co-Developed Test Kit to an End User, Bio-Techne shall be deemed to have made to
Sponsor with respect to such Co-Developed Test Kit the same warranty as
Bio-Techne makes to such End User.

 

6.     CO-DEVELOPED TEST KIT LABELING AND BRANDING

 

6.1     Labeling of Co-Developed Test Kits.

 

(a)     Establishment of Labeling. The labeling of the Co-Developed Test Kits
shall be established in conformity with the EUA in respect thereof (and from and
after any 510(k) clearance, de novo classification request, or other type of
required premarket review and authorization of the Co-Developed test Kits, in
conformity with the applicable requirements of the FDA in respect thereof) and
such other labeling requirements as are imposed by the FDA or any other
applicable Governmental Authority. The labeling of the Co-Developed Test Kits
shall be established by the Steering Committee from time to time, and any
differences shall be resolved through the Escalation Process.

 

(b)     Responsibilities of Sponsor in Respect of Labeling. Sponsor shall be
responsible for providing Bio-Techne instructions as to the labeling of the
Co-Developed Test Kits in order for the labeling to comply with applicable Law
and any End User-Specific Requirements. Sponsor shall also be responsible for
obtaining any necessary FDA approval with respect to the labeling of the
Co-Developed Test Kits, including any changes to the labeling of the
Co-Developed Test Kits.

 

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(c)     Responsibilities of Bio-Techne in Respect of Labeling. Without limiting
the legal responsibility of Sponsor as the manufacturer of record of the
Co-Developed Test Kits, as between Sponsor and Bio-Techne, Bio-Techne shall be
responsible for promptly and accurately implementing all instructions of Sponsor
relating to the labeling of the Co-Developed Test Kits pursuant to Section
6.1(b) without any Deviations or errors.   

 

6.2     Branding of the Co-Developed Test Kits. Subject to the terms of the
licenses granted in Section 6.3, the Co-Developed Test Kits shall be branded in
such manner as the Parties agree and is approved by the Steering Committee (with
any differences being resolved through the Escalation Process), provided that
such branding shall employ the marks, “Kantaro Biosciences”, “Mount Sinai” and
“R&D Systems”.

 

6.3     License under the Sponsor Licensed Marks and the Bio-Techne Licensed
Marks.

 

(a)     License Grant. Subject to the terms and conditions of this Agreement and
the ISMMS TM License Agreement, Sponsor hereby grants to Bio-Techne during the
Term a limited, revocable, non-assignable, non-transferable, non-exclusive,
non-sublicensable license to use the trademarks depicted and described on
Schedule 6.3(a) (the “Sponsor Licensed Marks”) throughout the world solely for
the Licensed Use, solely in accordance with the design specifications set forth
on Schedule 6.3(a) and solely in a manner that has been approved in advance by
ISMMS. The rights granted herein do not include any right to (i) use any of the
trademarks other than the Sponsor Licensed Marks, (ii) use the Sponsor Licensed
Marks for any purpose other than the Licensed Use, (iii) use the Sponsor
Licensed Marks as part of Bio-Techne’s legal name anywhere or in connection with
any other facility or operation, or (iv) register any trade or assumed name that
includes any of the Sponsor Licensed Marks. The rights granted herein do not
grant Bio-Techne any authority either (y) to act as agent for, or on behalf of,
Sponsor or any Mount Sinai Entity or (z) to represent or bind Sponsor or any
Mount Sinai Entity in any manner whatsoever.

 

(b)     Quality Control. Bio-Techne acknowledges, and is familiar with, the high
standards of quality, style, image, reputation and workmanship of Mount Sinai
Entities and recognizes the substantial value and goodwill associated with the
Marks; and that the Marks have acquired a secondary meaning as being synonymous
with the Mount Sinai Entities’ medical services and education of the highest
quality and pioneering health and medical research and related goods/services.
Accordingly, Bio-Techne recognizes the vital importance of protecting the Mount
Sinai Entities’ exclusive and valuable rights in and to the Marks and covenants
that it will at all times during the Term (i) conduct its business in accordance
with the highest medical, legal and ethical standards and in compliance with all
applicable Laws; (ii) use the Sponsor Licensed Marks in accordance with the
Mount Sinai Entities’ high standards and the requirements of this Agreement, and
(iii) use its best efforts to protect and enhance the goodwill pertaining to the
Sponsor Licensed Marks for the exclusive benefit of the Mount Sinai Entities.
Notwithstanding anything to the contrary contained in this Agreement, Bio-Techne
shall not use the Sponsor Licensed Marks in any manner that ISMMS, in its sole
and absolute discretion, deems to be illegal, improper, obscene, undesirable or
inconsistent with the professional image and reputation of the Mount Sinai
Entities. Bio-Techne may not modify or change the Sponsor Licensed Marks in any
manner.

 

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(c)     Marketing Activities. Bio-Techne agrees that any marketing, promotion or
advertising of the Co-Developed Test Kits using the Sponsor Licensed Marks shall
be pre-approved in writing by ISMMS in each instance. Bio-Techne shall submit
complete and accurate samples of each applicable proposed marketing, promotional
and advertising materials reflecting its intended use of the Sponsor Licensed
Marks to ISMMS and Sponsor for ISMMS’s and Sponsor’s review prior to commencing
any such use. In addition, ISMMS and/or Sponsor shall have the right to request
at any time samples of Bio-Techne’s then current marketing, promotional and
advertising materials that contain the Sponsor Licensed Marks and to reject any
such materials by Notice given to Bio-Techne if in ISMMS’s and Sponsor’s
reasonable discretion such materials would violate any term of this Agreement.
Upon the giving of any such Notice of rejection of any such materials,
Bio-Techne shall discontinue its use of such materials immediately and, if
reasonably requested by Sponsor and/or ISMMS, Bio-Techne shall at its expense
implement a corrective publicity program that has been approved by ISMMS and
Sponsor (such approval not to be unreasonably withheld).

 

(d)     License Restrictions. Bio-Techne agrees and covenants that it will in no
event use the Sponsor Licensed Marks in any way, or take any action (or fail to
take any action) that (i) could impair the validity or distinctiveness of the
Sponsor Licensed Marks, or otherwise that would tend to allow them to become
generic or (ii) in ISMMS’s reasonable opinion, might mislead the public or be
materially detrimental to, or inconsistent with the good name, goodwill,
reputation and image of any Mount Sinai Entity. During the Term and thereafter
(thus surviving termination or expiration of this Agreement for any reason),
Bio-Techne agrees and covenants that it will not, directly or indirectly through
any other Person (w) challenge the validity, enforceability, or any of the Mount
Sinai Entities’ use, registration or attempted registration, or ownership of the
Marks, whether or not registered, or cause any other Person (including any
government or quasi-governmental agency, including but not limited to
intellectual property organizations) to do so; (x) register, seek to register or
cause to be registered, any trade names, logos, trademarks, service marks, trade
dress, domain names, social media handles and user names, brand names, designs
or other proprietary indicia of goods and services for the Marks or confusingly
similar to the Marks even if used in conjunction with other words, phrases or
designations; (y) otherwise compromise the Marks or dispute any rights of ISMMS
or the other Mount Sinai Entities in and to the Marks; or (z) aid or encourage
any other Person in any manner in doing any of the foregoing ((w), (x) or (y)),
whether (under (w), (x) or (y)) anywhere in the world.

 

(e)     No Composite Mark Rights. Notwithstanding any of the foregoing, the
Parties hereby agree and acknowledge that Bio-Techne’s use of the Sponsor
Licensed Marks, which shall at all times be in compliance with the terms of this
Agreement, shall in no event permit Bio-Techne to use, create, file or register
any new or composite mark based on any Licensed Mark or which is confusingly
similar to any Licensed Mark, or confer to Bio-Techne any right, title or
interest in or to any of the Sponsor Licensed Marks (including any goodwill
associated therewith), except for the limited license grant expressly granted
herein, or any new or composite mark consisting of any Licensed Mark or which is
confusingly similar to any Licensed Mark. Without limiting the foregoing
provision, if Bio-Techne during the Term acquires any right, title or interest
in or to any Licensed Mark (including any goodwill associated therewith) beyond
the limited rights expressly granted herein, or any new or composite mark
consisting of any Licensed Mark or which is confusingly similar to any Licensed
Mark, Bio-Techne hereby irrevocably assigns to ISMMS, in each case without
additional consideration, all right, title and interest throughout the world and
in perpetuity in and to any such Licensed Mark or any new or composite mark
consisting of any Licensed Mark or any confusingly similar variation thereof
(including any goodwill associated therewith). Upon the request of ISMMS or
Sponsor, Bio-Techne shall each promptly take such further actions, including
execution and delivery of all appropriate instruments of conveyance, as may be
necessary to assist ISMMS to prosecute, register, perfect, record or enforce its
rights in any Licensed Mark or in any new or composite mark consisting of any
Licensed Mark or any confusingly similar variation thereof. In the event ISMMS
is unable, after reasonable effort, to obtain Bio-Techne’s signature on any such
documents, ISMMS hereby irrevocably designates and appoints ISMMS as
Bio-Techne’s agent and attorney-in-fact, to act for and on Bio-Techne’s behalf
solely to execute and file any such application or other document and do all
other lawfully permitted acts to further the prosecution and issuance of any
Intellectual Property right related to the Sponsor Licensed Marks or to any new
or composite mark consisting of any Licensed Mark with the same legal force and
effect as if Bio-Techne had executed them.

 

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(f)     Reserved Rights. ISMMS and Sponsor expressly reserve all rights not
expressly granted to Bio-Techne under this Agreement. Nothing in this Agreement
shall be construed to prevent Sponsor or any Mount Sinai Entity from granting
any other licenses for the use of the Sponsor Licensed Marks or from using the
Sponsor Licensed Marks in any manner whatsoever. Any use of the Sponsor Licensed
Marks in any manner that is not in complete conformity with the terms and
conditions of this Agreement and that is not cured within the time permitted by
this Agreement shall constitute a material breach of this Agreement. The license
under this Agreement to use the Sponsor Licensed Marks in accordance with this
Agreement does not confer any rights to any Marks other than the Sponsor
Licensed Marks.

 

(g)     Ownership. Bio-Techne hereby acknowledges and agrees that ISMMS is and
shall remain the exclusive owner of all right, title and interest in and to the
Marks, and that Bio-Techne’s use of the Sponsor Licensed Marks under this
Agreement and the goodwill associated therewith inures solely to the exclusive
benefit of the Mount Sinai Entities. Bio-Techne hereby acknowledges and agrees
that, other than the limited licenses granted hereunder, Bio-Techne has not
acquired, and shall not acquire, any right, title or interest in or to the Marks
anywhere in the world by virtue of this Agreement or Bio-Techne’s exercise of
the rights granted hereunder. Notwithstanding the foregoing, to the extent that
Bio-Techne acquires any right, title or interest in the Marks, including any
Intellectual Property rights therein, Bio-Techne hereby irrevocably assigns to
the applicable Mount Sinai Entity, for no additional consideration, Bio-Techne’s
entire right, title or interest in the Marks and any Intellectual Property
rights therein.

 

(h)     Enforcement. Bio-Techne shall immediately give Notice to ISMMS and
Sponsor upon becoming aware of: (i) any applications or petitions before any
intellectual property organizations, authorities or registrars seeking to
invalidate or challenge the Marks; and (ii) any actual or suspected infringement
of the License Marks. ISMMS shall have the sole and exclusive right (but not the
obligation) in its sole discretion to prosecute and enforce the Marks and shall
exclusively retain all recoveries, revenues and other remedies deriving
therefrom. Bio-Techne covenants that it will cooperate in good faith with ISMMS
at ISMMS’s expense in (y) the prosecution of any action, proceeding or claim
brought before any intellectual property organizations, authorities or
registrars, and (z) the defense or commencement of any judicial or
administrative action, proceeding or claim brought to protect or enforce the
Marks.

 

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(i)     Disclaimer of Representations and Warranties. BIO-TECHNE HEREBY AGREES
AND ACKNOWLEDGES THAT SPONSOR AND ISMMS MAKE NO REPRESENTATION OR WARRANTY
WHATSOEVER WITH RESPECT TO THE SPONSOR LICENSED MARKS, WHETHER EXPRESS OR
IMPLIED BY LAW, COURSE OF DEALING, COURSE OF PERFORMANCE, USAGE OF TRADE OR
OTHERWISE, INCLUDING, WITHOUT LIMITATION, THAT (I) ANY LICENSED MARK IS VALID;
(II) ANY APPLICATION TO REGISTER A MARK WILL PROCEED TO REGISTRATION OR, IF SUCH
REGISTRATION IS GRANTED, THAT SUCH REGISTRATION SHALL BE VALID; (III) THE
EXERCISE BY BIO-TECHNE OF THE RIGHTS GRANTED WITH RESPECT TO THE SPONSOR
LICENSED MARKS UNDER THIS AGREEMENT WILL NOT INFRINGE THE RIGHTS OF ANY PERSON.

 

(j)     Injunctive Relief. Bio-Techne hereby acknowledges and agrees that a
material breach of this Agreement with respect to provisions relating to the
Sponsor Licensed Marks or confidentiality provisions will cause Sponsor and
ISMMS irreparable damages, for which an award of damages would not be adequate
compensation and agrees that, in the event of such a breach, Sponsor and ISMMS
will be entitled to immediately seek equitable relief, including a restraining
order, injunctive relief, specific performance and any other relief that may be
available from any court or arbitration proceeding to restrain or otherwise
enjoin or compel the act or omission resulting in such breach, in addition to
and without prejudice to any other right or remedy to which Sponsor or ISMMS may
be entitled at law or in equity and, to the extent permitted by Law, Bio-Techne
consents and agrees that such remedy may be granted without any requirement that
Sponsor or ISMMS post a bond or other security or make a showing of irreparable
harm or lack of an adequate remedy at law. The remedies described in this
Section 6.3(j) shall not be deemed to be exclusive but shall be in addition to
all other remedies available at law or in equity, subject to any express
exclusions or limitations in this Agreement to the contrary.

 

(k)     Subject to the terms and conditions of this Agreement, Bio-Techne hereby
grants to Sponsor during the Term a limited, revocable, non-assignable,
non-transferable, non-exclusive, non-sublicensable license to use the trademarks
depicted and described on Schedule 6.3(k) (the “Bio-Techne Licensed Marks”)
throughout the world solely for the Licensed Use and in accordance with the
design specifications set forth on Schedule 6.3(k), and solely in a manner that
has been approved in advance by Bio-Techne.  Sponsor agrees that it is subject
to the same terms, restrictions, acknowledgements and obligations set forth in
Sections 6.3(a) through Section 6.3(j) regarding the Bio-Techne Licensed Marks
as is required of Bio-Techne with respect to the Sponsor Licensed Marks. 
Notwithstanding the foregoing, Bio-Techne agrees that all content in marketing,
promotion or advertising of the Co-Developed Test Kits other than the Bio-Techne
Licensed Marks shall be pre-approved in writing by ISMMS in each instance, which
approval shall not be unreasonably withheld. 

 

(l)     Sponsor and Bio-Techne may by mutual agreement add to or delete
trademarks from the definition of either of the Sponsor Licensed Marks or
Bio-Techne Licensed Marks (provided that in the case of any such addition or
deletion that affects the Marks of the Mount Sinai Entities, ISMMS shall first
have consented to such addition or deletion in writing).

 

7.

PRICING AND REIMBURSEMENT

 

7.1     Pricing and Terms of Sale of Co-Developed Test Kits. The Steering
Committee shall establish the list prices for the Co-Developed Test Kits and
shall establish (and approve any changes in) ranges and parameters for
Bio-Techne’s authority to determine End User-specific pricing of the
Co-Developed Test Kits (including any rebates, discounts or similar terms).
Bio-Techne, in consultation with Sponsor, shall establish the terms of sale
(e.g. shipping terms) for the Co-Developed Test Kits.

 

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7.2     Reimbursement Matters Affecting the Co-Developed Test Kits.

 

(a)     Responsibility of Sponsor. Sponsor shall use reasonable commercial
efforts to make such documentary and informational submissions as are necessary
in order for applicable Governmental Authorities to establish a rate at which
End Users will be reimbursed under the Medicare program for the administration
of the test contained in Co-Developed Test Kits.

 

(b)     Acknowledgements of Bio-Techne. Bio-Techne acknowledges that the
determination of reimbursement rates under the Medicare program lies within the
discretion of the applicable Governmental Authorities; that there can be no
assurance that any such reimbursement rate will be established for the
administration of the test contained in Co-Developed Test Kits or that if
established such rate will not be changed; or if any such reimbursement rate is
established for the administration of the test contained in Co-Developed Test
Kits that any third party payor other than the Medicare program will agree to
utilize such rate.

 

8.

SALES, DISTRIBUTION AND CUSTOMER SERVICE

 

8.1     Responsibilities for Commercialization Activities.

 

(a)     Responsibilities of Bio-Techne. Without limiting the legal
responsibility of Sponsor as the manufacturer of record of the Co-Developed Test
Kits, at all times during Phase II, as between Sponsor and Bio-Techne,
Bio-Techne shall be solely responsible for all aspects of the Commercialization
of the Co-Developed Test Kits that are not expressly ascribed to Sponsor under
this Agreement; provided, however, Sponsor shall retain the oversight
responsibilities provided for in Section 9 and the other applicable provisions
of this Agreement. With the support of a number of Working Groups established by
the Steering Committee the details of the responsibilities of Bio-Techne shall
include, without limitation: (i) promoting the Co-Developed Tests through
Bio-Techne’s website and other means that are in accordance with Law and that
have been approved by the Steering Committee, provided that all such promotional
activities shall be strictly in compliance with the advertising and labeling
requirements established by the EUA and/or other applicable Governmental
Authorities with Health Care Laws and other applicable Laws, and with the
standards established by the Steering Committee; (ii) taking and fulfilling
orders for Co-Developed Test Kits from End Users at prices established in
accordance with this Agreement; (iii) developing packaging for the Co-Developed
Test Kits that is of a quality and durability that is approved by the Steering
Committee (with the understanding that any text appearing on the packaging shall
be governed by the provisions of Section 6.1); (iv) developing and overseeing,
including tracking of the Co-Developed Test Kits and lots, safe and secure
shipping methods for the Co-Developed Test Kits and effectuating the delivery of
Co-Developed Test Kits in accordance with the terms of sale approved by the
Steering Committee; (v)Tracking and handling End User complaints and returns and
adverse events arising from the use of the Co-Developed Test Kits and providing
information and support to Sponsor in connection therewith in accordance with
the requirements of Section 9; (vi) collecting and accounting for the purchase
price payable by End Users in accordance with the pricing and other terms
established pursuant to this Agreement; (vii) acting as a fiduciary for Sponsor
with respect to the share of Adjusted Gross Receipts to which Sponsor is
entitled pursuant to Section 10; (viii) keeping complete and accurate books and
records with respect to all Commercialization activities relating to the
Co-Developed Test Kits including the books and records required by Section 9;
(ix) effectuating all reporting obligations ascribed to Bio-Techne pursuant to
Section 9; (x) providing all tracking reporting and accounting information in
real time as described in Section 8.6; and (xi) carrying out all aspects of the
Commercialization of the Co-Developed Test Kits that are not expressly ascribed
to Sponsor under this Agreement in an orderly and businesslike manner.

 

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(b)     Responsibilities of Sponsor. Sponsor shall refer to Bio-Techne all
inquiries received by the Sponsor from any potential End User during the Term.
Sponsor will provide technical support to Bio-Techne in responding to inquiries
from potential End-Users.

 

8.2     Sponsor as End User. To the extent that Sponsor and/or its Affiliates
are qualified to act as End Users, during Phase II Sponsor and such Affiliates
shall be entitled to purchase Co-Developed Test Kits from Bio-Techne on the same
pricing (taking into account applicable discounts for other End Users of similar
volumes), and other terms and conditions as apply to other End Users. With
respect to each production run of Co-Developed Test Kits, during the first two
months of such production run, Sponsor shall have the right by Notice to
Bio-Techne to designate up to [******] of such production run for purchase by
Mount Sinai Entities or other End Users designated by Sponsor, and Bio-Techne
shall adhere to such designation.

 

8.3     Embargoed Purchasers. Sponsor has advised Bio-Techne that ISMMS is
subject to certain restrictions that require that Co-Developed Test Kits not be
sold to certain entities in which a Mount Sinai Entity has a certain level of
equity interest (“Embargoed Purchasers”). Bio-Techne agrees not to sell
Co-Developed Test Kits to any End User that Sponsor has by Notice to Bio-Techne
designated as an Embargoed Purchaser.

 

8.4     Responding to Priority Governmental Needs. Sponsor and Bio-Techne
acknowledge and agree that the state and local Governmental Authorities in the
areas served by the Mount Sinai Entities and Bio-Techne respectively may request
or require priority in the supply of Co-Developed Test Kits, and that it will be
the policy of Sponsor and Bio-Techne to use reasonable commercial efforts to
respond to such requests and/or requirements to the extent permitted by Law. The
Steering Committee shall administer the response to any such requests and/or
requirements, and any differences will be resolved through the Escalation
Process. To the extent that federal, state and/or local Governmental Authorities
impose conflicting obligations on Bio-Techne with respect to the supply or
distribution of Co-Develop Test Kits, the Parties will immediately meet to
determine how best to comply with all applicable requirements of Law.

 

8.5     Policy with Respect to Back Orders. To the extent that the demand for
Co-Developed Test Kits exceeds the available supply of inventory, the Steering
Committee shall have the authority to determine (subject to the requirements of
applicable Law, and taking into account the provisions of Section 8.3), the
manner in which the available supply of inventory of the Co-Developed Test Kits
will be allocated (and if the Steering Committee is unable to reach consensus,
such determination will be made through the Escalation Process).

 

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8.6     Portal for Real-Time Commercialization Information. The Steering
Committee shall establish a Working Group for the purpose of collaborating on
the design and launch by Bio-Techne of an electronic data portal that is for the
specific use of Sponsor in tracking Commercialization information with respect
to the Co-Developed Test Kits (the “Portal”). The Working Group charged with the
design of the Portal shall take into account the existing information technology
infrastructure and data security needs of Bio-Techne so as to develop a Portal
that is both practicable for Bio-Techne and that provides the real-time access
to relevant information reasonably required by Sponsor. Within thirty (30) days
of the Effective Date, Bio-Techne shall launch such Portal and during Phase II,
Bio-Techne shall load into the Portal, on a daily basis, true, correct and
complete information with respect to the Commercialization of the Co-Developed
Test Kits in conformity with the requirements established by the Working Group.
The Steering Committee shall have the authority to modify the Portal terms. Any
differences as to whether the Portal design should be modified shall be resolved
through the Escalation Process.

 

8.7     Sponsor Rights with respect to Commercialization Responsibilities.

 

(a)     If at any time during Phase II, Sponsor and Bio-Techne mutually
determine and agree that a third-party distributor should be engaged to take on
specific commercial functions relating to the Co-Developed Test Kits in order to
accelerate distribution to specific marketplaces or to reallocate functions that
were initially the responsibility of Bio-Techne pursuant to the terms of this
Agreement, then the Parties shall jointly assign such functions to a mutually
agreed upon third-party distributor on terms mutually acceptable to both of the
Parties. The revenue received from any such third-party distributor shall be
considered cash actually received in consideration of the sale, licensing, use,
lease, transfer or other disposition of Co-Developed Test Kits for purposes of
determining Adjusted Gross Receipts and shall be subject to the terms of Section
10.2.

 

(b)     If at any time during Phase II Bio-Techne determines or is concerned
that it is unable or unwilling to discharge, or Sponsor reasonably determines or
is concerned that Bio-Techne is not discharging, specific product fulfillment,
billing, collections, customer service or similar obligations under this
Agreement at a level that is at least equal to the level of industry standards
for internationally-recognized manufacturers and distributors of in vitro
medical devices, the Steering Committee shall promptly convene to consider the
extent to which the issues that gave rise to such determinations and/or concerns
are within Bio-Techne’s control and to that extent how such issues can be
collaboratively addressed and resolved. The Steering Committee shall have the
authority to recommend any necessary changes to this Agreement that the Steering
Committee believes could resolve the applicable issues, but no change to this
Agreement shall be made except in accordance with Section 19.3. If after
reasonable efforts to collaboratively address the applicable issues the Sponsor
continues to believe that deficiencies exist in Bio-Techne’s performance of
specific product fulfillment, billing, collections, customer service or similar
obligations, and that the correction of such deficiencies is within Bio-Techne’s
control, then by Notice to Bio-Techne, Sponsor may require that any or all of
the responsibilities of Bio-Techne relating to product fulfillment, billing,
collections, customer service or similar functions ascribed to Bio-Techne in
this Section 8 be contracted to a third party organization whose core business
includes the Commercialization of in vitro medical devices on terms that
correspond to the terms of this Section 8 (and any other applicable provisions
of this Agreement), and, until Bio-Techne is able to demonstrate to the
reasonable satisfaction of Sponsor that Bio-Techne is able to discharge the
applicable functions at a level that is at least equal to the level of industry
standards for internationally-recognized manufacturers and distributors of in
vitro medical devices, Bio-Techne shall bear the reasonable costs charged by
such third party organization for the performance of the applicable
responsibilities without any right of reimbursement therefor.

 

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9.

QUALITY, COMPLIANCE OBLIGATIONS AND CERTAIN FINANCIAL MATTERS

 

9.1     Sponsor Audit at Bio-Techne.

 

(a)     Right to Oversee and Audit. Sponsor shall have the right as the
manufacturer of record of the Co-Developed Test Kits to take such action and
exercise such authority as Sponsor deems necessary or appropriate to oversee and
monitor the performance by Bio-Techne of its compliance with Health Care Laws
and its obligations to Sponsor under this Agreement. Without limiting the
generality of the foregoing, Bio-Techne agrees that Sponsor and/or any
representative of Sponsor shall at any reasonable agreeable time be entitled to
audit the quality systems of Bio-Techne insofar as they are pertinent to assess
Bio-Techne’s compliance with Health Care Laws and with the provisions of this
Agreement. Sponsor has the right to inspect and audit all of Bio-Techne’s
equipment facilities, operations, procedures, and records directly related to
any Sponsor product or to the system support used to process them, and to audit
and certify Bio-Techne’s laboratory where quality control testing of the product
is conducted. Terms and conditions for inspections and audits will be
established by the Steering Committee (or if necessary through the Escalation
Process).

 

(b)     Audit Process for Audits by Sponsor or Sponsor’s Authorized Contractor.
Depending on the extent of the audit, the audit team will consist of one (1) or
two (2) people, typically a lead auditor from quality assurance and a subject
matter expert. The audit team will develop an audit protocol to use during the
audit. The audit may last up to five (5) days and will include an opening
meeting, audit activities with a daily wrap-up meeting held between the audit
team and representatives of Bio-Techne to review audit progress, and a closing
meeting to discuss the observations. Within five (5) days of the closing
meeting, Sponsor will issue a draft audit finding report that includes
recommended action items as a courtesy to Bio-Techne for review and comment
within five (5) days of receipt to ensure that Bio-Techne is represented fairly.
Sponsor will take the comments from Bio-Techne into consideration, but is not
bound by the input, and may include agreed comments in the final report.

 

(c)     Report of Audit. Within fifteen (15) days of the conclusion of the
audit, Sponsor will provide a final written report of their findings along with
recommended action items to Bio-Techne. Bio-Techne will provide a written action
plan to Sponsor’s report to Sponsor within fifteen (15) days after receipt of
the report by Bio-Techne, unless Sponsor agrees to any extension.

 

(d)     Implementation of Action Items. Sponsor and Bio-Techne will agree to a
suitable time period to implement any action items. Bio-Techne will submit
progress reports to Sponsor on either a monthly or quarterly basis. At the end
of this period, the Sponsor audit team will schedule a follow-up audit, if
necessary, or obtain documented evidence of successful completion.

 

(e)     Follow-On Audit Activity. Subsequent audits may include an annual
product review to recap quality issues occurring over the past year, product
changes, and supplier performance. The continued suitability of this Agreement
may also be discussed.

 

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(f)     Right to Audit Records Relating to Sale of Co-Developed Test Kits. Upon
prior written notice to Bio-Techne and not more than once per Calendar Year,
Sponsor shall have the right to access during normal business hours of
Bio-Techne and on reasonable advance written notice, the applicable books and
records of Bio-Techne, as may be reasonably necessary to verify the accuracy of
the written report of the Adjusted Gross Receipts required to be delivered by
Bio-Techne to Sponsor pursuant to Section 10.2(b) of this Agreement. If such
audit shows any underpayment of Adjusted Gross Receipts by Bio-Techne, then,
within seven (7) days after Bio-Techne’s receipt of such report, Bio-Techne
shall remit to Sponsor:

 

(i)     the amount of such underpayment; and

 

(ii)     if such underpayment exceeds five percent (5%) of the total Adjusted
Gross Receipts owed for the Calendar Year then being reviewed, the reasonably
necessary fees and expenses of Sponsor relating to such audit, including, but
not limited to, fees of a third-party auditing firm performing such audit.

 

9.2     Audit, Inspection or Investigation of Bio-Techne by a Regulatory
Authority. Bio-Techne shall allow representatives of Regulatory Authorities to
inspect and audit its facility, the quality systems of Bio-Techne insofar as
they are pertinent to such Regulatory Authority’s audit in connection with the
Co-Developed Test Kits. Bio-Techne shall cooperate with any inquiry or
investigation by a Regulatory Authority with respect to Bio-Techne’s compliance
with Law in relation to the Co-Developed Test Kits and Bio-Techne’s marketing or
sale thereof. Bio-Techne shall immediately notify Sponsor of any inspection,
audit, inquiry or investigation made by a Regulatory Authority that may involve
the Co-Developed Test Kits, its facilities or business. Sponsor shall have the
option of having its representatives on-site, by video conference or by phone
during any such site visit by any Regulatory Authorities or meeting with such
Regulatory Authorities to discuss the ongoing inquiries, questions and results
of such inspection, audit, inquiry or investigation. Bio-Techne shall provide
Sponsor in writing of the results of such inspection, audit, inquiry or
investigation, immediately after such inspection, audit, inquiry or
investigation has occurred, including without limitation providing to Sponsor
copies of any resulting document of action (e.g., FDA Form 483 inspection
observation report, regulatory letters, etc.) resulting there from to the extent
relevant to Sponsor within five (5) days of their receipt. With the support of a
Working Group established for this purpose, Sponsor and Bio-Techne shall
collaborate in good faith in preparing responses to and plans of correction for
any issues raised in the course of such inspection, audit, inquiry or
investigation. The Working Group shall endeavor to fashion responses and plans
of correction that both achieve the necessary compliance objectives as promptly
as is reasonably practicable and that can be implemented by Bio-Techne on a
cost-effective basis. Bio-Techne acknowledges, however, that ultimately the
Sponsor is the manufacturer of record and therefore has legal responsibility for
regulatory compliance, and that therefore in the event that a consensus cannot
be achieved with respect to any response or plan of correction, Sponsor shall
have the authority to determine the final form and content of the response or
plan of correction, taking into account cost-effectiveness but also the need to
maintain continuity of production, and Sponsor shall be responsible for
submitting responses and plans of correction to the applicable Regulatory
Authority. Sponsor shall provide a copy of each final response and plan of
correction to Bio-Techne. If any Regulatory Authority determines that Bio-Techne
is not in compliance with any applicable Laws, Bio-Techne shall promptly inform
Sponsor of its plans to come into compliance with such Laws, to the extent the
Co-Developed Test Kits are or may be affected, and shall continue to keep
Sponsor informed of its progress until compliance has been attained.

 

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9.3     Quality Related Communication

 

(a)     Prior to 510(k) Clearance/Granting of de novo Classification Request.
Prior to the issuance of a 510(k) clearance or the granting of a de novo
classification request, with respect to the Co-Developed Test, and without
limiting the legal responsibility of Sponsor as the manufacturer of record of
the Co-Developed Test Kit, as between Sponsor and Bio-Techne, Bio-Techne shall
Manufacture the Co-Developed Lab Test in accordance with any and all
quality-related requirements imposed by the EUA, or the requirements of any
other applicable Regulatory Authority, and any End User-Specific Requirements in
respect of the Co-Developed Test Kit (including without limitation any
requirements of 21 C.F.R. Part 820 that are not waived by such EUA); provided,
however, Sponsor shall retain the oversight responsibilities provided for in
Section 9 and the other applicable provisions of this Agreement . The Steering
Committee shall have the authority to establish a compliance protocol (the “EUA
Compliance Protocol”) based upon the terms of the EUA, and the requirements of
any other applicable Regulatory Authority, in respect of the Co-Developed Test
Kit and to amend the EUA Compliance Protocol from time to time as deemed
necessary or appropriate by the Steering Committee (and any differences in the
Steering Committee shall be resolved through the Escalation Process). Upon the
establishment of the EUA Compliance Protocol, the EUA Compliance Protocol shall
be deemed to be incorporated by reference into this Agreement and to form a part
hereof.

 

(b)     Upon 510(k) Clearance / Granting of a de novo Classification Request.
Upon the issuance of 510(k) clearance or the granting of a de novo
classification request with respect to the Co-Developed Test, and without
limiting the legal responsibility of Sponsor as the manufacturer of record of
the Co-Developed Test Kit, as between Sponsor and Bio-Techne, Bio-Techne shall
Manufacture the Co-Developed Lab Test in accordance with 21 C.F.R. Part 820 and
any and all other applicable quality-related requirements imposed by the FDA, or
the requirements of any other applicable Regulatory Authority, and any End
User-Specific Requirements in respect of the Co-Developed Test Kit. The Steering
Committee shall have the authority to establish a compliance protocol (the “Part
820 Compliance Protocol”) based upon the requirements of 21 C.F.R. Part 820, and
the requirements of any other applicable Regulatory Authority, and to amend the
Part 820 Compliance Protocol from time to time as deemed necessary or
appropriate by the Steering Committee (and any differences in the Steering
Committee shall be resolved through the Escalation Process). Upon the
establishment of the Part 820 Compliance Protocol, the Part 820 Compliance
Protocol shall be deemed to be incorporated by reference into this Agreement and
to form a part hereof.

 

9.4     Quality Related Communication

 

(a)     Notification of Deviations. Bio-Techne shall notify Sponsor within two
(2) days in the event of any procedural Deviation from product specification,
the requirements of Section 9.3, or test failure for supplied product. Unless
otherwise obligated by law or impractical due to requiring an immediate
response, such as a spill, Bio-Techne shall consult with Sponsor before taking
action in connection with these events.

 

(b)     Sponsor Contact Person. Should Deviations arise, Bio-Techne will contact
Sponsor in accordance with this Agreement, to address the issues depending upon
the state of urgency. In such instances, the management representative at
Sponsor or designee will assign a contact person at Sponsor for further action.
As of the Effective Date, such contact person shall be the person listed on
Schedule 2.1(c).

 

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9.5     Resolution of Quality Issues. In accordance with this Agreement,
representatives from both the Sponsor and the Bio-Techne Quality Department will
be involved in resolution of quality issues, such as, but not limited to
Deviations, errors, or out of specification/aberrant-suspect results, in an
effort to reach a mutually agreeable decision. If a mutually agreeable
resolution is not reached with respect to a given quality issue, the matter will
be referred to the Steering Committee for resolution (if necessary through the
Escalation Process).

 

9.6     Component Control. Bio-Techne and Sponsor shall mutually agree upon the
specification of the Original Components and approved alternatives to the
Components that can be substituted for an Original Component (the “Approved
Alternative Components”) prior to the time of submission of applications for
EUA, 510(k) clearance or de novo classification, or the submission to any other
applicable Regulatory Authority. Bio-Techne shall have the authority on notice
to but without any further approval of Sponsor to make changes to the Original
Components to the extent such change is to an Approved Alternative Component.
Any changes to the Original Components or Approved Alternative Components, and
any changes to any Components that are substituted for Original Components
through the following process (other than through the substitution of Approved
Alternative Components), shall be determined as follows: (i) if Bio-Techne
desires to propose changes to any Component or Approved Alternative Component,
Bio-Techne shall provide Sponsor with a detailed description of such proposed
changes, and no such changes to the Components or Approved Alternative
Components, shall be introduced without Sponsor’s prior approval, (ii) if a
Component or Approved Alternative Component becomes unavailable, Bio-Techne
shall promptly provide Sponsor with a detailed description of a proposed
replacement (and if Sponsor requests, alternative replacement approaches), and
no such replacement shall be introduced without Sponsor’s prior approval, (iii)
if Sponsor desires to change a Component or an Approved Alternative Component
based on Sponsor’s belief that such change is required in order to comply with
regulatory requirements for which Sponsor is responsible as a result of
Sponsor’s position as manufacturer of record of the Co-Developed Test Kits,
Sponsor and Bio-Techne shall consult together (if necessary with the support of
a Working Group) to endeavor to achieve consensus on such change, however if
consensus is not able to be achieved then Sponsor shall have the ultimate
authority to require such change to be made, taking into consideration
considerations of cost-effectiveness but ultimately prioritizing the need for
regulatory compliance and quality, and (iv) if Sponsor desires to propose
changes to any Component or Approved Alternative Component for reasons other
than those described in clause (iii) of this sentence, then Sponsor shall
provide Bio-Techne with a detailed description of such proposed changes, and no
such changes to the Components or Approved Alternative Components shall be
introduced without Bio-Techne’s prior approval. Bio-Techne agrees to promptly
and precisely implement any changes to the Components or Approved Alternative
Components that have been determined pursuant to the process that is described
in this Section 9.6. Sponsor shall be responsible for making any submissions to
any Regulatory Authority with respect to any changes in Components or Approved
Alternative Components and Bio-Techne agrees to promptly make available to
Sponsor any and all support and documentation necessary in connection with such
filings. In addition, Bio-Techne shall notify Sponsor of changes in the
Manufacturing processes and methods, including, but not limited to:

 

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(a)     changes in Manufacturing processes which could reasonably be expected to
affect the function or quality of the Co-Developed Test Kits;

 

(b)     changes in Component or Approved Alternative Component suppliers which
could reasonably be expected to affect the quality of the Co-Developed Test
Kits; and

 

(c)     other changes which could reasonably be expected to affect the function
or quality of the Co-Developed Test Kits.

 

9.7     Annual Product Review

 

(a)     Review Activities. Where appropriate, a periodic product review will be
prepared and reviewed according to Bio-Techne’s policies and procedures. All
review activities, which are the responsibility of Bio-Techne, will be completed
and documented as per a mutually agreed timeframe. The annual product review
documentation completed by Bio-Techne will be provided to Sponsor for review.

 

(b)     Quality Reviews. The Steering Committee will meet periodically to review
quality issues related to the obligations and responsibilities as described in
this Agreement. During this periodic review, quality issues related to the past
production by Bio-Techne will be reviewed. The information presented and
discussed during the review meeting will be documented by Bio-Techne as a part
of the Annual Product Review. The Steering Committee will approve the final
draft.

 

9.8     Regulatory Filing Requirements.

 

(a)     Bio-Techne Support of Sponsor Reporting Obligations. If Sponsor is
required to submit to the Regulatory Authorities any information concerning the
processing or Manufacturing of any of the Co-Developed Test Kits from
Bio-Techne, Bio-Techne will promptly provide to Sponsor copies of documentation,
data, and other information with respect to processing, packaging, and the
facility as shall be reasonably necessary. Bio-Techne shall also make available
its cooperation and consultation if reasonably requested by Sponsor and/or
required by the Regulatory Authorities for development of additional data or
performance of studies concerning Sponsor products. Bio-Techne shall also
promptly provide, if required by the Regulatory Authorities, information
concerning its production processes and quality control procedures with respect
to the product. Bio-Techne shall promptly provide to Sponsor all documentation,
data, and information reasonably in advance of their required submission to
allow for Sponsor review. Bio-Techne shall endeavor in good faith to
satisfactorily resolve all reasonable Sponsor comments raised during review
prior to submission if such submission is to be made by Sponsor Terms for
development of additional data or performance studies will be mutually agreed
upon in writing.

 

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(b)     Submission of Regulatory Documentation. If Sponsor is required or
intends to submit any documentation to, or otherwise communicate with the FDA,
and those communications directly relate to the Co-Developed Test Kits in a
material manner, prior to any submission or communication, Sponsor will discuss
the submission of such documentation or communication with Bio-Techne; provided,
however, Sponsor shall determine, in its sole discretion, the manner in which to
submit such documentation or communicate to the FDA. Bio-Techne shall advise
Sponsor in advance of any major planned changes to any documents, which directly
relates to the Co-Developed Test Kits. Sponsor shall determine if the change
requires FDA notification and, if appropriate, submit Sponsor-specific changes
to the FDA. Bio-Techne shall notify Sponsor immediately of any adverse finding
by the FDA that directly relates to the Co-Developed Test Kits or that could
affect them. Sponsor agrees to inform Bio-Techne of any communication with the
FDA which affect Bio-Techne’s obligations hereunder. For all other
communications or submission of documentation to any Regulatory Authority other
than the FDA, Sponsor shall determine, in its sole discretion, whether such
communication or submission of documentation shall be made by the Sponsor, the
Parties jointly or by Bio-Techne. Bio-Techne shall immediately Notify and keep
Sponsor informed of any adverse finding by any Regulatory Authority that
directly relates to the Co-Developed Test Kits or that could affect them.

 

9.9     Outsourcing and Vendor Qualification. Bio-Techne will notify Sponsor
prior to outsourcing of any aspect of manufacturing or testing and has the
responsibility to ensure that the agreed upon third party is compliant with all
applicable regulations. Bio-Techne shall obtain written authorization from
Sponsor prior to outsourcing.

 

9.10     Storage of Documentation by Bio-Techne.

 

(a)     Maintenance of Product Documentation. Upon Sponsor’s request, Bio-Techne
agrees to promptly make available to Sponsor all documentation related to the
Co-Developed Test Kits. Bio-Techne shall keep all documentation that relates to
the Co-Developed Test Kits in a manner so as to protect and secure the
documentation against damage, destruction, unintended changes, or disposal
during the required time of storage. Bio-Techne shall keep and maintain all such
documentation in accordance with Bio-Techne’s own policies and procedures and in
compliance with 21 C.F.R. Part 820, and the requirements of any other applicable
Regulatory Authority. Bio-Techne shall maintain records of test usage and ensure
that any records associated with the EUA or any other clearance or approval of
any Regulatory Authority are maintained until notified by Sponsor that such
records may be disposed of. Bio-Techne shall not destroy any records described
or referenced in this Section 9.10(a) unless and until so authorized by Sponsor.

 

(b)     Storage Requirements. In order for Sponsor to comply with its
obligations under Law as manufacturer of record of the Co-Developed Test,
Bio-Techne shall keep backup copies of all documentation relating to the
Co-Developed Test and Co-Developed Test Kits until authorized by Sponsor to
destroy such documentation. For the archiving of data, media, diskettes, and
similar media, Bio-Techne shall keep the original media and back-up copies in
separate locations protected against damage, destruction, and or disposal during
the required time of storage.

 

9.11     Product Specifications. Bio-Techne has the responsibility to have an
established specification control procedure. Sponsor requires that the
Components and Product will have written Specifications or SOPs under
change/revision control. Specifications or SOPs serve as a basis for component
and product quality evaluation. For any Major Changes to the Specification or
SOPs, Bio-Techne shall give Notice to Sponsor and shall not implement such
changes unless and until Sponsor approves such changes. Bio-Techne shall use its
internal Specifications (approved by Sponsor) to test Components and Product. No
materials shall be released or used before the evaluation of Sponsor has been
completed.

 

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9.12     Product Complaints. Without limiting the legal responsibility of
Sponsor as the manufacturer of record of the Co-Developed Test, as between
Sponsor and Bio-Techne, Bio-Techne shall be responsible for the collection and
compilation in a compliant way of all information of which Bio-Techne becomes
aware and that is necessary for compliance by Sponsor in respect of all known
adverse event reporting and complaint-related requirements that are applicable
to the Co-Developed Test Kits, with Sponsor retaining (i) the responsibility to
provide to Bio-Techne any scientific or technical information that has been
developed by ISMMS and that Bio-Techne requires to effectuate such compliant
collection and compilation and (ii) oversight responsibility as provided in
Section 9 and the other applicable provisions of this Agreement. Bio-Techne
shall in compliance with applicable Law track all adverse events of which
Bio-Techne becomes aware, including any occurrence of false results, and shall
provide to Sponsor all information that Sponsor requires in order to fulfill its
reporting obligations to FDA under 21 C.F.R. Part 803, and the requirements of
any other applicable Regulatory Authority. Bio-Techne shall be responsible for
the compliant collection and compilation of all information of which Bio-Techne
becomes aware or that is requested by Sponsor and that is necessary to enable
Sponsor to comply with adverse event or complaint information received (from End
Users, patients and/or Regulatory Authorities) and shall deliver all such
information to Sponsor promptly upon receipt by Bio-Techne. Upon request by
Sponsor and to the extent required by Law, Bio-Techne will investigate each such
adverse event and complaint and provide a written report on the results of the
investigation to Sponsor within fifteen (15) days. To the extent that Sponsor,
applicable Law or any Regulatory Authority so requires, Bio-Techne will conduct
a root cause analysis of any such complaint and if required by the Steering
Committee will involve the Steering Committee or a subcommittee thereof or a
Working Group in the root cause analysis. Bio-Techne will communicate with the
applicable End User the results of the complaints investigation, if necessary or
required by Law or the Sponsor, provided that each such communication shall have
been approved in advance by Sponsor.

 

9.13     Compliance Program. At all times during the Manufacturing process,
Bio-Techne shall maintain with respect to the Co-Developed Test Kits a device
master record and index, a quality management program and standard operating
procedures that are (i) consistent with industry standards, (ii) no less
stringent than those described in the applicable submissions for EUA, 510(k)
clearance or de novo classification, or submissions to any other applicable
Regulatory Authority and (iii) reasonably approved by Sponsor. A Working Group
may oversee such quality programs and may recommend changes or additions
thereto. In addition, at least ten (10) days prior to the sale of the first
Co-Developed Test Kit, Bio-Techne shall provide to Sponsor a copy of
Bio-Techne’s compliance program for compliance with Health Care Laws relating to
fraud and abuse. Promptly upon receipt of such compliance program, Sponsor shall
review and provide Bio-Techne with recommended changes to such compliance
program, which Bio-Techne agrees to implement prior to the sale of the first
Co-Developed Test Kit.

 

9.14     Compliance with Requirements Established by Non-U.S. Governmental
Authorities. At such time as any non-U.S. Governmental Authority approves the
sale and distribution of the Co-Developed Test Kit outside the U.S., upon
reasonable consultation with Bio-Techne, Sponsor shall have the unilateral right
by Notice given to Bio-Techne to supplement this Section 9 with any additional
protocols and obligations of Bio-Techne necessary to satisfy any applicable
requirements established by any non-U.S. Governmental Authority (and effective
upon the giving of such Notice the terms of such additional protocols and
obligations shall be deemed to have been incorporated by reference into this
Agreement for all purposes).

 

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9.15     Quality Agreement. Simultaneously herewith, Sponsor and Bio-Techne are
entering into the Quality Agreement. To the extent that any term of the Quality
Agreement conflicts with any term of this Section 9, the applicable term of this
Agreement shall prevail. To the extent that this Section 9 or the Quality
Agreement addresses a subject that is not addressed in the other, the fact that
the other agreement is silent as to such subject shall not affect the
construction or interpretation of the terms of this Agreement or the Quality
Agreement (as applicable) that apply to such subject. The Parties acknowledge
that the Quality Agreement may provide for reporting and compliance terms and
obligations that are not specifically set forth in this Section 9.

 

10.

ECONOMIC OBLIGATIONS AND CASH MANAGEMENT.

 

10.1     Responsibility for Expenses. Each Party shall be responsible for its
own expenses incurred by such Party in the performance of such Party’s
obligations under this Agreement, without any right of reimbursement from the
other Party or any right to recoup such expenses prior to the division of
Adjusted Gross Receipts that is contemplated by this Section 10.

 

10.2     Sharing of Adjusted Gross Receipts.

 

(a)     Adjusted Gross Receipts from End Users of Co-Developed Test Kits. To the
extent that during the Term Adjusted Gross Receipts arise from sales of
Co-Developed Test Kits to End Users, Bio-Techne shall pay to Sponsor [******] of
such Adjusted Gross Receipts.

 

(b)     Payment of Share of Adjusted Gross Receipts. For each month in Phase II,
including the month in which the Term ends, Bio-Techne will pay the amounts due
to Sponsor as set forth in Section 10.2(a) as follows: (i) in the case of the
last month in Bio-Techne’s first, second and third fiscal quarter, within
twenty-one (21) days after the end of such month, (ii) in the case of the last
month in Bio-Techne’s fiscal year, within thirty (30) days after the end of such
month and (iii) for all other months, within fifteen (15) days after the end of
such month. Together with each payment, Bio-Techne shall account to Sponsor for
all Adjusted Gross Receipts arising during the applicable calendar month and
shall deliver to Sponsor a written report of all such Adjusted Gross Receipts in
the form prescribed by Sponsor. Bio-Techne shall pay to Sponsor by wire transfer
to the account of which Sponsor shall give Notice to Bio-Techne the amount
required to be paid to Sponsor in respect of such Adjusted Gross Receipts by the
terms of this Section 10. Sponsor and Bio-Techne shall, by mutual agreement,
true-up and reconcile any differences in monthly accounting and payments on a
calendar quarterly basis.

 

(c)     Sales at Below Cost of Production. To the extent that Governmental
Authorities require the testing kits to be sold at below the cost of production,
in lieu of the revenue sharing provisions of Section 10.2(b) through (d),
Sponsor and Bio-Techne shall divide the applicable Adjusted Gross Receipts
proportionately to each Party’s expenses in connection with the applicable
sales.

 

(d)     Resolution of Payment Related Differences. If Sponsor has any
differences with any calculation of any amount required to be paid to Sponsor
pursuant to this Section 10, such differences shall promptly be referred to the
Steering Committee, and any differences that the Steering Committee is unable to
resolve shall be resolved through the Escalation Process.

 

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11.

RUO MATTERS

 

11.1     Selling or Distributing Co-Developed Test Kits for Research Use Only.
The Steering Committee shall establish a Working Group for the purpose of
considering the timing and appropriate scope of distribution of Co-Developed
Test Kits for Research Use Only and the conditions and terms under which such
Co-Developed Test Kits will be sold. After deliberation and mutual agreement by
the Working Group as to the conditions and terms under which such Co-Developed
Test Kits will be sold, the Parties will memorialize such terms in an addendum
(the “RUO Addendum”) to this Agreement, with the understanding that at a minimum
the following terms will be included in the RUO Addendum:

 

(a)     Bio-Techne shall pay to Sponsor [******] of Adjusted Gross Receipts
arising from sales of Co-Developed Test Kits for Research Use Only; and

 

(b)      Subject to the terms of Section 6.3, the Co-Developed Test Kits sold
for Research Use Only shall be branded as “Mount Sinai ‘powered by’ R&D Systems”
in such a manner as is approved by the Parties.

 

12.

REPORTING

 

12.1     Required Bio-Techne Reports. During the Term, Bio-Techne shall provide
to Sponsor in a timely manner all reports required to be provided by Bio-Techne
to Sponsor under this Agreement. Except as may be determined by Sponsor under
Section 9.8(b) or otherwise as expressly authorized under this Agreement, in no
event shall Bio-Techne communicate directly with any Governmental Authority in
respect of the Co-Developed Test Kits.

 

12.2     Required Sponsor Reports. During the Term, Sponsor shall provide to
Bio-Techne in a timely manner all reports required to be provided by Sponsor to
Bio-Techne under this Agreement. Sponsor shall also file or submit in a timely
manner all reports required to be filed or submitted by Sponsor to any
Governmental Authority as the manufacturer of record of the Co-Developed Test
Kits. Promptly upon the provision thereof to any Governmental Authority, Sponsor
shall provide to Bio-Techne a copy of any report filed or submitted by Sponsor
with any Governmental Authority by the terms of this Agreement or applicable Law
with respect to the Co-Developed Test Kits.

 

12.3     Other Reports. The Steering Committee may from time to time prescribe
other reports that are required to be provided by Bio-Techne to Sponsor or by
Sponsor to Bio-Techne, including the content and the timing thereof.

 

13.

OTHER COVENANTS OF THE PARTIES

 

13.1     ISO 13485. At all times during the Term, Bio-Techne covenants that it
shall be certified to be in compliance with the ISO 13485:2016 Quality System
Standards. The notified body that issues any certificate of compliance to
Bio-Techne shall be a body that is authorized by FDA to conduct audits under the
Medical Device Single Audit Program (MDSAP).

 

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13.2     [******]

 

13.3     Further Assurances. Each of Party hereto shall, and shall cause their
respective Affiliates to, execute and deliver such additional documents,
instruments, conveyances and assurances and take such further actions as may be
reasonably required to carry out the provisions hereof and give effect to the
transactions contemplated by this Agreement and the other Transaction Documents.

 

13.4     Confidentiality. The Parties agree that all information communicated or
provided by either Party to the other Party pursuant to or in connection with
this Agreement is subject to the terms of the Bio-Techne NDA, which such terms
are hereby incorporated by this reference.

 

13.5     Press Releases. Without limiting the provisions of Section 6, neither
Party shall issue any press release that names the other Party or any Mount
Sinai Entity or that specifically refers to the transactions contemplated by
this Agreement without the express prior written consent of the other Party,
provided that Bio-Techne shall have the right to issue a press release or make a
securities filing that, in the opinion of counsel to Bio-Techne, Bio-Techne is
required by federal securities laws to issue or file so long as Bio-Techne
consults with Sponsor with respect thereto and (to the extent permitted by Law)
provides to Sponsor a copy of such press release or securities filing as much in
advance of the issuance or filing as is feasible. The Parties shall agree upon
the form, content and release date of a joint press release to be issued upon
the execution of this Agreement.

 

13.6     Independent Activities; Non-Exclusivity. The only obligations
undertaken by the Parties are those expressly provided in this Agreement. Each
Party may engage in whatever activities it chooses, whether or not the same be
competitive with the activities contemplated herein, without having or incurring
any obligation to offer any interest in such activities to the other Party, and
the other Party hereby waives, relinquishes and renounces any such right or
claim of participation. The Parties expressly confirm and agree that this
Agreement is non-exclusive. Nothing herein shall be deemed to give rise to an
obligation on the part of either Party to deal exclusively with the other Party,
nor to any obligation of either party to take or refrain from taking any action
that would have the effect of increasing the amount of Adjusted Gross Receipts
that may be derived from the Commercialization of the Co-Developed Test. Without
limiting the generality of the foregoing, Bio-Techne recognizes that (i) Sponsor
has licensed and in the future may continue to license to third parties the same
Intellectual Property as is licensed to Bio-Techne hereunder; (ii) Sponsor shall
have the right to enter into agreements and arrangements with third parties that
are similar to and/or have the same or similar objectives as this Agreement
(even if such agreements and arrangements result in products being
Commercialized that are competitive with the Co-Developed Test Kits); and (iii)
nothing in this Agreement shall be construed in a manner that would limit the
ability of ISMMS or any other Mount Sinai Entity to carry out its or their
research, education or patient care charitable missions.

 

13.7     ISMMS License Agreements. During the Term, Sponsor hereby agrees not to
amend, modify or terminate (or consent to or approve any amendment or
modification of) the ISMMS License Agreements in any manner that would adversely
affect the rights of Bio-Techne under this Agreement.

 

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14.

REPRESENTATIONS AND WARRANTIES OF BIO-TECHNE

 

Bio-Techne hereby represents and warrants to Sponsor that the statements
contained in this Section 14 are true and correct as of the Effective Date,
except to the extent that any such representation or warranty refers to a
specified date, in which event such representation or warranty shall be true and
correct as of such specified date.

 

14.1     Organization and Qualification of Bio-Techne. Bio-Techne is duly
organized, validly existing and in good standing under the Laws of the State of
Minnesota and has all necessary corporate power and authority to own, operate or
lease the properties and assets now owned, operated or leased by it and to carry
on its business as currently conducted. Bio-Techne is duly licensed or qualified
to do business and is in good standing in each jurisdiction in which the
operation of its business as currently conducted makes such license or
qualification necessary.

 

14.2     Authority. Bio-Techne has all necessary corporate power and authority
to enter into this Agreement and the other Transaction Documents to which it is
or will be a party, to carry out its obligations hereunder and thereunder and to
consummate the transactions contemplated hereby and thereby. The execution and
delivery by Bio-Techne of this Agreement and any other Transaction Document to
which Bio-Techne is or will be a party, the performance by Bio-Techne of its
obligations hereunder and thereunder and the consummation by Bio-Techne of the
transaction contemplated hereunder and thereunder have been duly authorized by
all requisite corporate action on the part of Bio-Techne, and no other
proceedings on the part of Bio-Techne is required to authorize the execution,
delivery and performance thereof by such Person. When each Transaction Document
to which Bio-Techne is or will be a party has been duly executed and delivered
by Bio-Techne (assuming due authorization, execution and delivery by each other
party thereto), such Transaction Document will constitute a legal and binding
obligation of Bio-Techne, enforceable against it in accordance with its terms,
except as such enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar Laws affecting creditors’ rights generally
and by general equitable principles (regardless of whether enforcement is sought
in a proceeding at law or in equity).

 

14.3     No Conflicts; Consents. The execution and delivery by Bio-Techne of
this Agreement and the other Transaction Documents to which it is or will be a
party, and the consummation of the Transaction, and performance by Bio-Techne of
the obligations hereunder and thereunder, do not and will not: (a) conflict with
or result in a violation or breach of, or default under, any provision of the
certificate of incorporation, bylaws or other organizational documents of
Bio-Techne in any material respect; (b) conflict with or result in a violation
or breach of any provision of any Law or Order applicable to Bio-Techne or its
business as currently conducted; (c) require the consent, notice or other action
by any Person under, conflict with, result in a violation or breach of,
constitute a default or an event that, with or without notice or lapse of time
or both, would constitute a material default under or result in the termination
or acceleration of or create in any party a right of purchase, sale,
acceleration, termination, modification or cancellation under, any material
contract to which Bio-Techne is a party; or (d) result in the creation or
imposition of any lien or encumbrance on the Co-Developed Test Kits. The
execution and delivery by Bio-Techne of this Agreement and the other Transaction
Documents to which it is or will be a party, and the consummation of the
transactions contemplated herein and therein, and performance by Bio-Techne of
the obligations hereunder and thereunder will not conflict with or result in a
violation or breach of any provision of any Contract. Other than the
Governmental Approvals, no consent, approval, Permit, Order, declaration or
filing with, or notice to, any Governmental Authority is required by or with
respect to Bio-Techne in connection with the execution and delivery of this
Agreement the other Transaction Documents and the performance and consummation
by Bio-Techne.

 

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14.4     Compliance With Laws; Permits.

 

(a)     Bio-Techne has materially complied, and is now in material compliance,
with all Laws applicable to this Agreement, the Co-Developed Test Kits and to
the conduct of its business as currently conducted.

 

(b)     All Permits required for Bio-Techne to conduct its business as currently
conducted or for the ownership and use of its properties and assets to be used
in connection with the Co-Developed Test Kits have been obtained by Bio-Techne
and are valid and in full force and effect. All fees and charges with respect to
such Permits as of the Effective Date have been paid in full. No event has
occurred that, with or without notice or lapse of time or both, would reasonably
be expected to result in the revocation, suspension, lapse or limitation of any
of Bio-Techne’s Permits necessary for the Development, Manufacturing and
Commercialization of the Co-Developed Test Kits pursuant to this Agreement and
the other Transaction Documents.

 

14.5     Intellectual Property. Bio-Techne represents and warrants that (i) it
is the sole and exclusive legal and beneficial owner of all right, title and
interest in and to the Bio-Techne Background IP free and clear of Encumbrances,
(ii) it has full and sufficient right, title and authority to grant the rights
and licenses granted to Sponsor hereunder, (iii) the Bio-Techne Background IP
does not contain any materials developed by a third party and used by
Bio-Techne, except pursuant to a license agreement, and (iv) the Bio-Techne
Background IP does not infringe any Intellectual Property rights of a third
party.

 

14.6     Insurance. Bio-Techne or its Affiliates maintain fire, liability,
product liability, umbrella liability, real and personal property, workers’
compensation, vehicular, fiduciary liability and other casualty and property
insurance, including the insurance set forth on Schedule 17.2, relating to its
business as currently conducted, its properties and assets (collectively, the
“Insurance Policies”). There are no Actions related to Bio-Techne’s business as
currently conducted, its properties and assets pending under any such Insurance
Policies as to which coverage has been questioned, denied or disputed or in
respect of which there is an outstanding reservation of rights. Neither
Bio-Techne nor any of its Affiliates has received any written notice of
cancellation of, premium increase with respect to, or alteration of coverage
under, any of such Insurance Policies. All premiums due on such Insurance
Policies have either been paid or, if not yet due, accrued. All such Insurance
Policies (a) are in full force and effect and enforceable in accordance with
their terms; (b) are provided by carriers who are financially solvent; and (c)
have not been subject to any lapse in coverage. None of Bio-Techne or any of its
Affiliates is in default under, or has otherwise failed to comply with, in any
material respect, any provision contained in any such Insurance Policy. The
Insurance Policies are of the type and in the amounts customarily carried by
Persons conducting a business similar to Bio-Techne’s business as currently
conducted and are sufficient for compliance with all applicable Laws and
Contracts to which Bio-Techne is a party or by which it is bound.

 

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14.7     Due Diligence. All documents, data and materials delivered by
Bio-Techne to Sponsor in connection with any due diligence request of Sponsor
were true, correct and complete when delivered.

 

14.8     ISO 13485. Bio-Techne has been certified to be in compliance with the
ISO 13485:2016 Quality System Standards by a notified body that FDA has
authorized to conduct audits under the Medical Device Single Audit Program
(MDSAP).

 

15.

REPRESENTATIONS AND WARRANTIES OF SPONSOR

 

Sponsor hereby represents and warrants to Bio-Techne that the statements
contained in this Section 15 are true and correct as of the Effective Date,
except to the extent that any such representation or warranty refers to a
specified date, in which event such representation or warranty shall be true and
correct as of such specified date.

 

15.1     Organization and Qualification of Sponsor. Sponsor is duly organized,
validly existing and in good standing under the Laws of the State of New York
and has all necessary corporate power and authority to own, operate or lease the
properties and assets now owned, operated or leased by it and to carry on its
business as currently conducted. Sponsor is duly licensed or qualified to do
business and is in good standing in each jurisdiction in which the operation of
its business as currently conducted makes such license or qualification
necessary.

 

15.2     Authority. Sponsor has all necessary corporate power and authority to
enter into this Agreement and the other Transaction Documents to which it is or
will be a party, to carry out its obligations hereunder and thereunder and to
consummate the transactions contemplated hereby and thereby. The execution and
delivery by Sponsor of this Agreement and any other Transaction Document to
which Sponsor is or will be a party, the performance by Sponsor of its
obligations hereunder and thereunder and the consummation by Sponsor of the
transaction contemplated hereunder and thereunder have been duly authorized by
all requisite corporate action on the part of Sponsor, and no other proceedings
on the part of Sponsor is required to authorize the execution, delivery and
performance thereof by such Person. When each Transaction Document to which
Sponsor is or will be a party has been duly executed and delivered by Sponsor
(assuming due authorization, execution and delivery by each other party
thereto), such Transaction Document will constitute a legal and binding
obligation of Sponsor, enforceable against it in accordance with its terms,
except as such enforceability may be limited by bankruptcy, insolvency,
reorganization, moratorium or similar Laws affecting creditors’ rights generally
and by general equitable principles (regardless of whether enforcement is sought
in a proceeding at law or in equity).

 

15.3     Intellectual Property. Sponsor represents and warrants that (i) the
rights to use the MS Background IP have been duly and validly licensed by ISMMS
to Sponsor for purposes of this Agreement pursuant to the ISMMS IP License
Agreement, (ii) it has full and sufficient right, title and authority to grant
the rights and licenses granted to Bio-Techne hereunder, (iii) the MS Background
IP does not contain any materials developed by a third party and used by
Sponsor, except pursuant to a license agreement, (iv) the MS Background IP does
not infringe any Intellectual Property rights of a third party, and (v) the
copies of the ISMMS License Agreements made available to Bio-Techne prior to the
Effective Date are true, correct and complete copies, with the competitively
sensitive and confidential terms thereof redacted. As of the Effective Date,
each ISMMS License Agreement is in full force and effect.

 

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16.

DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITIES

 

16.1     DISCLAIMER OF WARRANTIES. EXCEPT AS IS EXPRESSLY SET FORTH IN SECTION
15.3, SPONSOR AND ISMMS MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY
KIND, EITHER EXPRESSED OR IMPLIED, WITH RESPECT TO THE MS LAB TEST OR ANY
MATERIAL DELIVERED BY SPONSOR TO BIO-TECHNE. THERE ARE NO EXPRESS OR IMPLIED
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT THE
USE OF THE MATERIAL WILL NOT INFRINGE ANY PATENT, COPYRIGHT, TRADEMARK, OR OTHER
PROPRIETARY RIGHTS.  RECIPIENT ASSUMES ALL RISKS ASSOCIATED WITH THE USE OF THE
MATERIAL UNDER THIS AGREEMENT.

 

16.2     CONSEQUENTIAL DAMAGES. NOTWITHSTANDING ANYTHING CONTAINED IN THIS
AGREEMENT TO THE CONTRARY, NEITHER PARTY OR ITS AFFILIATES, MEMBERS, TRUSTEES,
DIRECTORS, OFFICERS, EMPLOYEES, AND/OR FACULTY MEMBERS SHALL BE LIABLE IN ANY
MANNER FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR EXEMPLARY DAMAGES
OF THE OTHER PARTY OR THE OTHER PARTY’S AFFILIATES, MEMBERS, TRUSTEES,
DIRECTORS, OFFICERS, EMPLOYEES, AND/OR FACULTY MEMBERS, EVEN IF SUCH PARTY,
AFFILIATE(S), MEMBER(S) TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND/OR FACULTY
MEMBERS HAS BEEN INFORMED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES. EACH
PARTY UNCONDITIONALLY AND IRREVOCABLY FOREVER WAIVES, ON BEHALF OF ITSELF, ITS
AFFILIATES, MEMBERS, TRUSTEES, DIRECTORS, OFFICERS, EMPLOYEES, AND/OR FACULTIES,
ANY RIGHT TO SEEK SPECIAL, CONSEQUENTIAL, INCIDENTAL, PUNITIVE OR EXEMPLARY
DAMAGES HEREUNDER. THE LIMITATION IN THIS SECTION 16.2 SHALL NOT APPLY TO (I)
THE PARTIES’ INDEMNIFICATION OBLIGATIONS (II) ANY BREACH BY EITHER PARTY OF SUCH
PARTY’S OBLIGATIONS TO THE OTHER UNDER ANY WRITTEN CONFIDENTIALITY OR
NON-DISCLOSURE AGREEMENT ENTERED INTO BY THE PARTIES WHETHER PRIOR TO OR AFTER
THE DATE HEREOF, OR (III) ANY VIOLATION BY EITHER PARTY OF SUCH PARTY’S
OBLIGATIONS UNDER THIS AGREEMENT WITH RESPECT TO THE INTELLECTUAL PROPERTY OF
THE OTHER PARTY.

 

16.3     NO LIABILITY OF ISMMS. BIO-TECHNE HEREBY ACKNOWLEDGES AND AGREES THAT
IN NO EVENT SHALL ISMMS HAVE ANY LIABILITY TO BIO-TECHNE FOR THE OBLIGATIONS OR
LIABILITIES OF SPONSOR UNDER THIS AGREEMENT UNDER ANY THEORY OF VICARIOUS
LIABILITY INCLUDING WITHOUT LIMITATION ANY THEORY IN THE NATURE OF ACTUAL OR
APPARENT AGENCY OR ALTER EGO.

 

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17.

INDEMNITY AND INSURANCE

 

17.1     Indemnification.

 

(a)     Bio-Techne Indemnification. Bio-Techne, at its sole cost and expense,
shall defend, indemnify and hold harmless Sponsor, its Affiliates, each of the
Mount Sinai Entities and each and every one of their respective subsidiaries,
parents, and Affiliates, and their respective trustees, directors, officers,
members, shareholders, faculty members, medical staff, employees, students,
agents and representatives (collectively, the “Sponsor Indemnitees”) from and
against any third-party Action, and shall pay and reimburse each of them for,
any and all related Losses incurred or sustained by, or imposed upon, the
Sponsor Indemnitees in favor of any third party to the extent based upon,
arising out of, with respect to or by reason of: (i) any negligent or more
culpable act or omission of Bio-Techne (including any reckless or willful
misconduct) in connection with the performance of its obligations under this
Agreement; (ii) Bio-Techne and its Affiliates’ conduct of business activities
that are unrelated to the activities contemplated by this Agreement; (iii) any
bodily injury, death of any person, or damage to real or tangible personal
property to the extent caused by the negligent or more culpable acts or
omissions of Bio-Techne (including any reckless or willful misconduct); (iv) any
breach or non-fulfillment of any of Bio-Techne’s representation, warranty, or
covenant under this Agreement (including without limitation any responsibilities
allocated to Bio-Techne under this Agreement); (v) any infringement of
Intellectual Property rights of any Person relating to the Bio-Techne Background
IP; or (vi) any failure by Bio-Techne to comply with any applicable Law in the
performance of its obligations under this Agreement.

 

(b)     Sponsor Indemnification. Sponsor agrees, at its sole cost and expense,
to indemnify and hold harmless Bio-Techne, Bio-Techne’s Affiliates, and each and
every one of their respective directors, officers, members, shareholders,
employees, agents and representatives (collectively, the “Bio-Techne
Indemnitees”), from and against any third-party Action, and shall pay and
reimburse each of them for, any and all related Losses incurred or sustained by,
or imposed upon, the Bio-Techne Indemnitees in favor of any third party to the
extent based upon, arising out of, with respect to or by reason of: (i) any
negligent or more culpable act or omission of Sponsor (including any reckless or
willful misconduct) in connection with the performance of its obligations under
this Agreement; (ii) Sponsor’s and its Affiliates’ conduct of business
activities that are unrelated to the activities contemplated by this Agreement;
(iii) any breach or non-fulfillment of any of Sponsor’s representation,
warranty, or covenant under this Agreement (including without limitation any
responsibilities allocated to Sponsor under this Agreement); (iv) any
infringement of Intellectual Property rights of any Person relating to the
Sponsor Background IP or the Sponsor Licensed Marks; or (v) any failure by
Sponsor to comply with any applicable Law in the performance of its obligations
under this Agreement.

 

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(c)     Indemnification Procedure. The indemnified Party agrees to provide the
indemnifying Party with prompt written notice of any Action to which this
indemnification applies, provided that a failure of the indemnified Party to
give written notice shall not affect the indemnifying Party’s obligations
hereunder to the indemnified Party except to the extent of actual prejudice
suffered by the indemnifying Party due solely to the failure to give such
written notice. The indemnifying Party shall have the exclusive right to control
the defense of any such Action, at its sole expense and risk, provided that the
indemnifying Party agrees in writing in connection with the Action that the
indemnifying Party will fully indemnify and defend the other Party and the
related indemnitees and shall comply with the following:

 

The indemnifying Party, upon the written request of such indemnified Party,
shall, or upon written notice to such indemnified Party may elect to, assume the
defense of such proceeding, at the indemnifying Party’s own expense, with
counsel reasonably satisfactory to such indemnified Party. Such indemnified
Party shall have the right to employ separate counsel in any such proceeding and
to participate in the defense thereof, but the fees and expenses of such counsel
shall be at the expense of such indemnified Party unless (i) the indemnifying
Party has agreed in writing to pay such reasonable fees and expenses, (ii) the
indemnifying Party has failed to assume the defense, pursue the defense
reasonably diligently or to employ counsel in a reasonably timely manner, (iii)
outside counsel to such indemnified Party has advised such indemnified Party in
writing that in such proceeding there is an actual or potential conflict of
interest or a conflict on any material issue between the indemnifying Party’s
position and the position of such indemnified Party, provided that the
indemnifying Party shall be responsible for the reasonable fees and expenses of
only one separate outside counsel at any time for all such indemnified Parties,
which outside counsel shall be designated in writing by the indemnifying Party.

 

The indemnifying Party shall not settle, or consent to the entry of any judgment
in, any Action without obtaining either: (y) an unconditional release of the
indemnified Party and its related indemnitees from all liability with respect to
all Actions underlying the applicable proceeding, such release not to include
any limitation on the indemnified Party’s rights to do business or to its rights
under this Agreement or any admission of wrongdoing; or any other injunctive
relief; or (z) the prior written consent of the indemnified Party.

 

If the indemnifying Party fails to acknowledge in writing its obligation to
defend against each proceeding, the indemnified Party shall be free to dispose
of the matter, at the expense of the indemnifying Party, in any way in which the
indemnified Party reasonably deems to be in its best interest.

 

An indemnified Party may obtain separate counsel of the indemnified Party’s
choice if such indemnified Party reasonably believes the indemnifying Party’s
and such indemnified Party’s interests may conflict. An indemnified Party’s
undertaking of defense and/or settlement will in no way diminish the
indemnifying Party’s obligation to indemnify such indemnified Party and to hold
it harmless. In either case, the indemnifying Party will also reimburse such
indemnified Party (and all other indemnified Parties) upon demand for all
losses, including reasonable attorneys’ fees and court costs the indemnified
Party incurs to protect itself, or to remedy the indemnifying Party’s defaults.
Under no circumstances will the indemnified Parties be required to seek recovery
from Third Parties or otherwise mitigate their losses to maintain an Action
against the indemnifying Party, and their failure to do so will in no way reduce
the amounts recoverable from the indemnifying Party by the indemnified Parties.

 

17.2     Insurance. During the Term and for a period of five years after the
last date on which the applicable Party continues to exploit any Jointly Owned
Intellectual Property, each Party will procure and maintain insurance policies,
which initially shall be for the coverages, minimum premium amounts and other
related requirements as set forth on Schedule 17.2; provided however that
Sponsor shall not be required to procure and maintain such insurance until the
date of shipment of the first Co-Developed Test to an End User. At any time
during the Term, the Steering Committee shall have the authority by Notice given
to both Parties to require both Parties to increase the insurance requirements
set forth on Schedule 17.2. Within sixty (60) days after the giving of such
Notice, each Party shall obtain and thereafter maintain such increased insurance
for the period set forth in the first sentence of this Section 17.2.

 

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18.

TERM AND TERMINATION

 

18.1     Term and Termination.

 

(a)     Term. The term of this Agreement (the “Initial Term”) commences on the
Effective Date and continues thereafter until the that date that is five (5)
years following the Effective Date, unless and until sooner terminated as
provided in 18.1(c).

 

(b)     Renewal. Upon expiration of the Initial Term, this Agreement shall
automatically renew for an additional successive twelve (12) months unless
either Party provides written notice of nonrenewal at least ninety (90) days
prior to the end of the then-current term or unless sooner terminated as
provided in Section 18.1(c) (such period, a “Renewal Term” and together with the
Initial Term, the “Term”). If the Term is renewed for a Renewal Term pursuant to
this Section 18.1(b), the terms and conditions of this Agreement during each
such Renewal Term shall be the same as the terms and conditions in effect
immediately prior to such renewal. If either Party provides timely notice of its
intent not to renew this Agreement, then, unless otherwise sooner terminated in
accordance with its terms, this Agreement shall terminate on the expiration of
the then-current Term.

 

(c)     Termination.  

 

(i)     With Cause. This Agreement may be terminated before the expiration date
of the Term on written notice:

 

(1)     by either Party, if the other Party materially breaches any provision of
this Agreement and either the breach cannot be cured or, if the breach can be
cured, it is not cured by the breaching Party within the following period after
the giving by the non-breaching Party of notice of such breach to the breaching
Party: (A) in the case of any breach that relates to any requirement of
applicable Law and that under applicable Law must be cured or remediated by a
specific date or that under applicable Law gives rise to an obligation to make a
filing or submit a report by a specific date, the period that ends five (5) days
before such date; or (B) in the case of any breach not described in clause (A)
that with reasonable diligence can be cured within thirty (30) days, a period of
thirty (30) days; or (C) in the case of any breach not described in clause (A)
that with reasonable diligence cannot be cured within thirty (30) days, that
period within which with reasonable diligence such breach could reasonably be
cured but not more than a period of thirty (60) days; or

 

(2)     by either Party, if the other Party (A) becomes insolvent, (B) is
generally unable to pay, or fails to pay, its debts as they become due, (C)
files, or has filed against it, a petition for voluntary or involuntary
bankruptcy or pursuant to any other insolvency law, (D) makes or seeks to make a
general assignment for the benefit of its creditors, or (E) applies for, or
consents to, the appointment of a trustee, receiver or custodian for a
substantial part of its property or business.

 

(ii)     Failure to Obtain EUA. If, notwithstanding the compliance by the
Parties with their obligations under this Agreement, EUA is not obtained in
respect of a Co-Developed Test Kit by the Outside Date, either Party may
terminate this Agreement by notice to the other Party.

 

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(iii)     End of EUA Period. Notwithstanding anything to the contrary herein, at
the End of the EUA Period the Parties shall assess in good faith the demand for
and economics of the Co-Developed Test Kits, and within thirty (30) days after
the End of the EUA Period, the Parties shall mutually determine whether to
continue the efforts to obtain FDA 510(k) approval for the Co-Developed Test Kit
as an IVD, the efforts to obtain the approval of the applicable Governmental
Authorities in other countries for the sale of the Co-Developed Test Kits, and
the Manufacturing and Commercialization of the Co-Developed Test Kits pursuant
to this Agreement. Unless within such thirty (30) day period the Parties agree
to continue the efforts to obtain FDA 510(k) approval for the Co-Developed Test
Kit as an IVD, the efforts to obtain the approval of the applicable Governmental
Authorities in other countries for the sale of the Co-Developed Test Kits, and
the Manufacturing and Commercialization of the Co-Developed Test Kits pursuant
to this Agreement, either Party shall have the right to terminate this Agreement
effective as of the end of such thirty (30) period.

 

18.2     Effect of Termination.  

 

(a)     No Release. The expiration or termination of this Agreement, for any
reason, shall not release either Party from any obligation or liability to the
other Party, including any payment and delivery obligation, that: (i) has
already accrued hereunder; (ii) comes into effect due to the expiration or
termination of the Agreement; or (iii) otherwise survives the expiration or
termination of this Agreement. The Party terminating this Agreement, or in the
case of the expiration of this Agreement, each Party, shall not be liable to the
other Party for any damage of any kind (whether direct or indirect) incurred by
the other Party by reason of the expiration or termination of this Agreement.

 

(b)     Return of Materials and Property. Each Party shall promptly, following
the expiration or termination of this Agreement: (i) return to the other Party
all documents and tangible materials (and any copies) containing, reflecting,
incorporating, or based on the other Party’s Confidential Information; provided,
however, that Sponsor may retain copies of any Confidential Information of
Bio-Techne incorporated in the Co-Developed Test Kits or to the extent necessary
to allow it to make full use of the Co-Developed Test Kits; (ii) permanently
erase all of the other Party’s Confidential Information from its computer
systems, except for copies that are maintained as archive copies on its disaster
recovery and information technology backup systems in which case such copies
shall be destroyed upon the normal expiration of the backup files; and (iii)
return to the other Party all tangible property in its possession or control,
belonging to the other Party.

 

(c)     Sponsor Option to Acquire. If Sponsor terminates this Agreement pursuant
to Section 18.1(d) as a result of a material breach by Bio-Techne or an event or
occurrence described in Section 18.1(d)(ii) affecting Bio-Techne, then Sponsor
shall have the option, but not the obligation, to acquire from Bio-Techne all
unsold Co-Developed Test Kits and all work in progress related to the
Co-Developed Test Kits in production for a purchase price equal to Bio-Techne’s
cost of production therefor (which Sponsor may offset against any damages
suffered or incurred by Sponsor as a result of such material breach or
termination).

 

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(d)     Negotiation of Sponsor Rights Upon Termination Under Section 18.1(c)(i).
If Sponsor terminates this Agreement pursuant to Section 18.1(c)(i), then
Sponsor shall have the right, by Notice given to Bio-Techne within thirty (30)
days after such termination, to elect to enter into arrangements with other
manufacturers to continue the Manufacture and Commercialization of the
Co-Developed Test using the Bio-Techne Background IP to the extent necessary
(and for such purpose to access and utilize the tangible materials describing
the Bio-Techne Background IP that have been escrowed pursuant to Section 3.5),
subject to the Parties reaching agreement (each in its sole discretion, but with
the understanding that each Party will negotiate in good faith to endeavor to
reach agreement) with respect to the terms on which Sponsor may exercise such
right.

 

(e)     Negotiation of Bio-Techne Rights Upon Termination Under Section
18.1(c)(iii). If Sponsor exercises its right to terminate this Agreement
pursuant to Section 18.1(c)(iii), then Bio-Techne shall have the right, by
Notice given to Sponsor within thirty (30) days after such termination, to elect
to pursue obtaining 510(k) approval for the Co-Developed Test Kit at its sole
expense with Bio-Techne acting as the manufacturer of record, and thereafter to
Manufacture and Commercialize Co-Developed Test Kits, subject to the Parties
reaching agreement (each in its sole discretion, but with the understanding that
each Party will negotiate in good faith to endeavor to reach agreement) with
respect to the terms on which Bio-Techne may exercise such right.

 

18.3     Survival of Terms. In addition to any provision which by its terms
contemplates performance after the Term, the following provisions shall survive
the expiration or termination of this Agreement: Section 3.2(d); Section 3.3;
Section 5.3; Section 6.3(d); Section 6.3(f); Section 6.3(g); Section 6.3(j);
Section 9.8; Section 9.10; Section 10; Section 11; Section 13.3; Section 13.4;
Section 16; Section 17; Section 18; Section 19.2; Section 19.8; Section 19.9;
and Section 19.11.

 

19.

ADDITIONAL PROVISIONS

 

19.1     Independent Contractors. The Parties are independent contractors.
Nothing contained in this Agreement is intended to create an agency, partnership
or joint venture between the Parties. At no time will either Party make
commitments or incur any charges or expenses for or on behalf of the other
Party.

 

19.2     Compliance with Laws. Bio-Techne shall comply with all prevailing Laws
that apply to its activities or obligations under this Agreement. For example,
Bio-Techne will comply with applicable United States export Laws. The transfer
of certain technical data and commodities may require a license from the
applicable agency of the United States government and/or written assurances by
Bio-Techne that Bio-Techne will not export data or commodities to certain
foreign countries without prior approval of the agency. Sponsor does not
represent that no license is required, or that, if required, the license will
issue.

 

19.3     Modification, Waiver and Remedies. This Agreement may only be modified
by a written amendment that is executed by an authorized representative of each
Party. Any waiver must be express and in writing. No waiver by either Party of a
breach by the other Party will constitute a waiver of any different or
succeeding breach. Unless otherwise specified, all remedies are cumulative.

 

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19.4     Assignment.

 

(a)     General. Except as otherwise provided in this Section 19.4, neither
Party may transfer, delegate or assign or otherwise dispose of this Agreement or
any of its rights, duties, or obligations under this Agreement without the prior
written consent of the other Party, which consent may be granted or denied in
such Party’s sole discretion.

 

(b)     Assignment by Sponsor. Notwithstanding the provisions of Section
19.4(a), with the prior written consent of Bio-Techne (which Bio-Techne shall
not unreasonably condition, withhold or delay), Sponsor may assign, delegate or
subcontract Sponsor’s rights and obligations hereunder to an Affiliate of
Sponsor or to a Person which succeeds to Sponsor’s business through a sale,
merger, consolidation, corporate reorganization, sale of all or substantially
all of Sponsor’s assets, change of name or like event, provided that no such
assignment shall relieve Sponsor of any duty, liability or responsibility under
this Agreement (for all of which Sponsor shall remain primarily liable).

 

(c)     Assignment by Bio-Techne. Notwithstanding the provisions of Section
19.4(a), with the prior written consent of Sponsor (which Sponsor shall not
unreasonably condition, withhold or delay), Bio-Techne may assign, delegate or
subcontract Bio-Techne’s rights and obligations hereunder to an Affiliate of
Bio-Techne or to a Person which succeeds to Bio-Techne’s business through a
sale, merger, consolidation, corporate reorganization, sale of all or
substantially all of Bio-Techne’s assets, change of name or like event, provided
that no such assignment shall relieve Bio-Techne of any duty, liability or
responsibility under this Agreement (for all of which Bio-Techne shall remain
primarily liable).

 

19.5     Notices. Except as otherwise expressly set forth herein, any notice or
other required communication under this Agreement (each, a “Notice”) must be in
writing, addressed to the Party’s respective Notice Address, and delivered
personally or by globally recognized express delivery service, charges prepaid.
A Notice will be deemed delivered and received: (a) in the case of personal
delivery, on the date of such delivery; and (b) in the case of a globally
recognized express delivery service, five (5) days from transmittal by Sponsor
to the address below. Notwithstanding the foregoing, during the pendency of any
federally- or state-declared disaster emergency, Notices may be given by email
addressed to the email address(es) provided below, provided that a Notice given
by email shall only be deemed to have been given upon affirmative
acknowledgement of receipt by the recipient (which shall not be deemed to have
occurred by the generation of a machine-generated acknowledgment). The “Notice
Address” of each Party is as follows:

 

if to Sponsor, to:

Kantaro Biosciences LLC

1460 Broadway

New York, New York 10036

Attn: Chief Operating Officer

Email: [******]

 

Kantaro Biosciences LLC

c/o Mount Sinai Innovation Partners

One Gustave L. Levy Place

Box 1675

New York, New York 10029-6754

Attn: President

Email: [******] 

 

46

--------------------------------------------------------------------------------

 

 

With a copy to (which shall not constitute notice):

Icahn School of Medicine at Mount Sinai

One Gustave L. Levy Place

Box 1099

New York, New York 10029-6574

Attn: General Counsel

Email: [******] 

   

if to Bio-Techne, to:

Bio-Techne Corporation

Attn: President/CEO

614 McKinley Place NE

Minneapolis, MN 55413

Email: legal@bio-techne.com

   

With a copy to (which shall not constitute notice):

Attn: Legal

legal@bio-techne.com

 

19.6     Severability and Reformation. If any provision of this Agreement is
held to be invalid or unenforceable by a court of competent jurisdiction, then
the remaining provisions of this Agreement will remain in full force and effect.
Such invalid or unenforceable provision will be revised by such court to be a
valid or enforceable provision that comes as close as permitted by Law to the
Parties’ original intent.

 

19.7     Headings and Counterparts. The headings of the articles and sections
included in this Agreement are inserted for convenience only and are not
intended to affect the meaning or interpretation of this Agreement. This
Agreement may be executed in several counterparts, and execution signatures may
be exchanged electronically including by facsimile or as scanned e-mail
attachments, and signatures so exchanged shall be considered as original for all
purposes and taken together will constitute one and the same instrument.

 

19.8     Governing Law. This Agreement will be governed and construed in
accordance with the Laws of the State of New York, without giving effect to the
conflict of law provisions of any jurisdiction.

 

19.9     Dispute Resolution; Venue. If a dispute arises between the Parties
concerning any right or duty under this Agreement, then the Parties will attempt
to resolve the dispute through the Escalation Process. If the Parties are unable
to resolve the dispute amicably through the Escalation Process, the Parties each
hereby irrevocably submit to the exclusive jurisdiction of the state and federal
courts located in the borough of Manhattan, New York, New York.

 

19.10     Integration. This Agreement, together with all attached Schedules, and
the other Transaction Documents contain the entire agreement between the Parties
with respect to the Co-Developed Test Kits, and supersedes all other oral or
written representations, statements, or agreements with respect to such subject
matter, including but not limited to, the term sheet exchanged prior to this
Agreement.

 

47

--------------------------------------------------------------------------------

 

 

 

19.11     Third Party Beneficiaries. Bio-Techne acknowledges and agrees that
each provision in this Agreement that names or refers to ISMMS shall be deemed
to be have been made for the benefit of ISMMS. ISMMS shall be a third party
beneficiary of this Agreement and shall be entitled to enforce the provisions
hereof.

 

19.12     Force Majeure. If either Party fails to fulfill its obligations
hereunder (other than an obligation for the payment of money), when such failure
is due to an act of God, or other circumstances beyond its reasonable control,
including but not limited to fire, flood, civil commotion, riot, war (declared
and undeclared), revolution, action of a Governmental Authority arising from a
pandemic or other public health emergency, or embargoes, then said failure shall
be excused for the duration of such event and for such a time thereafter as is
reasonable to enable the parties to resume performance under this Agreement,
provided however, that in no event shall such time extend for a period of more
than one hundred eighty (180) days.

 

19.13     Certain Conventions. Any reference in this Agreement to an Article,
Section, subsection, paragraph, clause, or Schedule shall be deemed to be a
reference to an Article, Section, subsection, paragraph, clause, or Schedule of
or to, as the case may be, this Agreement, unless otherwise indicated. Unless
the context of this Agreement otherwise requires, (a) all definitions set forth
herein shall be deemed applicable whether the words defined are used herein with
initial capital letters in the singular or the plural, (b) the word “will” shall
be construed to have the same meaning and effect as the word “shall,” (c) any
definition of or reference to any agreement, instrument or other document herein
shall be construed as referring to such agreement, instrument or other document
as from time to time amended, supplemented or otherwise modified (subject to any
restrictions on such amendments, supplements or modifications set forth herein),
(d) any reference herein to any Party shall be construed to include the Party’s
successors and assigns, (e) the word “notice” shall mean notice in writing
(whether or not specifically stated) and shall include notices, consents,
approvals and other written communications contemplated under this Agreement,
(f) provisions that require that a Party or the Parties “agree,” “consent” or
“approve” or the like shall require that such agreement, consent or approval be
specific and in writing, whether by written agreement, letter, approved minutes
or otherwise (but excluding e-mail and instant messaging), (g) references to any
specific Law, rule or regulation, or article, section or other division thereof,
shall be deemed to include the then-current amendments thereto or any
replacement or successor Law, rule or regulation thereof, (h) words of any
gender include each other gender, (i) words such as “herein,” “hereof” and
“hereunder” refer to this Agreement as a whole and not merely to the particular
provision in which such words appear, (j) the words “include,” “includes” and
“including” shall be deemed to be followed by the phrase “but not limited to,”
“without limitation,” “inter alia” or words of similar import, and (k) “days”
shall mean “calendar days.” In the event an ambiguity or question of intent or
interpretation arises, this Agreement shall be construed as if drafted jointly
by the Parties and no presumption or burden of proof shall arise favoring or
disfavoring any Party by virtue of the authorship of any of the provisions of
this Agreement.

 

19.14     Business Day Requirements. In the event that any notice or other
action is required to be taken by a Party under this Agreement on a day that is
not a business day, then such notice or other action shall be deemed to be
required to be taken on the next occurring business day.

 

[Signature Page Follows]

 

 

--------------------------------------------------------------------------------

 

 

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective
Date.

 

SPONSOR:

 

Kantaro Biosciences LLC

 

 

 

By:/S/ Erik Lium

Name: Erik Lium

Its: Chairman, Board of Managers

BIO-TECHNE:

 

Bio-Techne Corporation

 

 

 

By:/S/ Chuck Kummeth

Name: Chuck Kummeth

Its: Chief Executive Officer

 

 

[Signature Page to Development, Supply and Commercialization Agreement]

 

--------------------------------------------------------------------------------

 

 

Schedule 2.1(c)

 

Initial Steering Committee Members; Initial Designated Executives; Initial
Sponsor Contact Person for Quality Issues

 

 

 

Initial Steering Committee Members:

 

Sponsor:

 

 

●

[******]

 

●

[******]

 

Bio-Techne:

 

 

●

[******]

 

●

[******]

 

 

Initial Designated Executives:

 

Sponsor:

 

 

●

[******]

 

Bio-Techne:

 

 

●

[******]

 

 

Initial Sponsor Contact Person for Quality Issues:

 

 

●

[******]

 

Schedule 2.1(c)

1

--------------------------------------------------------------------------------

 

 

Schedule 2.1(e)

 

Initial Working Groups

 

 

1.

Commercial

 

2.

Logistics

 

3.

Customer Service

 

4.

Product Definition

 

5.

Regulatory and Quality

 

6.

Data Communications and IT

 

7.

Government Contracting

 

Schedule 2.1(e)

1

--------------------------------------------------------------------------------

 

 

Schedule 3.1(a)

 

Specifications and Performance Standards

 

[To be supplied; Parties to agree on schedule as soon as practicable]

 

Schedule 3.1(a)

1

--------------------------------------------------------------------------------

 

 

Schedule 5.2(a)

 

Manufacturing Milestones

 

[******]

 

 

Schedule 5.2(a)

1

--------------------------------------------------------------------------------

 

 

Schedule 6.3(a)

 

Sponsor Licensed Marks and Design Specifications for Usage

 

 

 

Mark

Registration Number

 

Classes of Goods/Services

MOUNT SINAI

5,298,636

41, 42, 44

MOUNT SINAI

5,234,607

36, 41, 42, 44, 45

MOUNT SINAI and Mountain Design

[ex_187264img001.jpg]

5,234,608

36, 41, 42, 44, 45

MOUNTAIN Design

[ex_187264img002.jpg]

4,558,806

36, 41, 42, 44, 45

 

 

Brand and Style Guidelines. The Marks shall be used in accordance with ISMMS’s
Brand Guidelines (the “Brand Guidelines”) published on
www.mountsinaibrandcenter.org (the “Site”), which may be updated by ISMMS from
time to time in its sole discretion. Such changes to the Brand Guidelines will
be posted to the Site.

 

Schedule 6.3(a)

1

--------------------------------------------------------------------------------

 

 

Schedule 6.3(k)

 

Bio-Techne Licensed Marks and Design Specifications for Usage

 

 

 

Mark

Registration Number

 

Classes of Goods/Services

R&D SYSTEMS

3,119,257

001, 005

BIO-TECHNE

4,692,993

001, 009

[ex_187264img003.jpg]

4,842,997

001

[ex_187264img004.gif]

4,932,928

009

 

Schedule 6.3(k)

1

--------------------------------------------------------------------------------

 

 

Schedule 17.2

 

Insurance

 

In accordance with the requirements of Section 17.2, the Parties shall maintain,
at their own expense, in full force and effect the following insurance:

 

 

●

Commercial general liability insurance with a liability limit of [******] per
occurrence and [******] in the annual aggregate and naming Sponsor and ISMMS as
an additional insured covering personal and advertising injury, bodily injury
and property damage.

 

 

●

Product liability insurance coverage with limits of [******] per claim and
[******] in the aggregate covering products, completed operations, bodily injury
and property damage. Bio-Techne’s coverage shall be written on a “claims made”
basis and such insurance shall name, to the fullest extent permitted by Law, the
Sponsor Indemnitees as additional insureds.

 

 

●

Life Sciences Errors & Omissions insurance with limits of [******] liability per
claim and [******] in the aggregate for bodily injury, property damage and
financial injury. Bio-Techne’s insurance shall name, to the fullest extent
permitted by Law, the Sponsor Indemnitees as additional insureds.

 

 

●

Workers’ Compensation Insurance as required by laws and regulations applicable
to Bio-Techne and covering any employees performing Bio-Techne’s obligations
hereunder. 

 

 

●

Employers’ Liability Insurance with a limit of [******] protecting against
liability for employee bodily injury arising out of an employee/employer
relationship.

 

 

●

System Security/Cyber Liability insurance with limits of [******] per occurrence
and [******] in the aggregate covering damages and expenses related to breaches
of data security from Bio-Techne’s obligations hereunder. 

 

 

●

Bio-Techne to secure transit/warehouse insurance.

 

Schedule 17.2

1