Exhibit 10.4

Confidential Materials omitted and filed separately with the

Securities and Exchange Commission. Double asterisks denote omissions.

 

 

 

 

 

 

 

 

[gnhmo5dgyo1b000001.jpg]

 

GRANT AGREEMENT

Investment ID OPP1189138

 

AGREEMENT SUMMARY & SIGNATURE PAGE

 

GRANTEE INFORMATION

Name:

Arsanis Inc

Tax Status:

Not exempt from federal income tax under U.S. IRC § 501(c)(3)

You confirm that the above information is correct and agree to notify the
Foundation immediately of any change.

Expenditure Responsibility:

This Agreement is subject to “expenditure responsibility” requirements under the

U.S. Internal Revenue Code.

Mailing Address:

890 Winter Street

Suite 230

Waltham, MA 02451-1472 United States

Primary Contact:

[**]

 

FOUNDATION INFORMATION

Mailing Address:

P. O. Box 23350, Seattle, WA  98102, U.S.A.

Primary Contact:

[**]

 

AGREEMENT INFORMATION

Title:

Respiratory Syncytial Virus (RSV) Program: Optimization Proposal

“Charitable Purpose”:

To optimize and further characterize anti respiratory syncytial virus (RSV)
monoclonal antibodies (mAbs) towards the prevention of RSV in infants in the
developing world

“Start Date”:

Date of last signature.

“End Date”:

August 31, 2018

This Agreement includes and incorporates by this reference:

This Agreement Summary & Signature Page and:

●Grant Amount and Reporting & Payment Schedule (Attachment A)

●Terms and Conditions (Attachment B)

●List of Developing Countries (Attachment C)

●Proposal Narrative (date submitted April 10, 2018)

●Results Framework and Tracker (date submitted April 11, 2018)

●Budget (date submitted April 11, 2018)

 

THIS AGREEMENT is between Arsanis Inc (“Arsanis,” “You” or “Grantee”) and the
Bill & Melinda Gates Foundation (“Foundation”), and is effective as of the date
of last signature. Each party to this Agreement may be referred to individually
as a “Party” and together as the “Parties.” As a condition of this grant, the
Parties enter into this Agreement by having their authorized representatives
sign below.

 

 

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

 

BILL & MELINDA GATES FOUNDATION

 

ARSANIS INC

 

 

 

 

 

/s/ Lynda Stuart

 

/s/ Mike Gray

 

 

 

By:

Lynda Stuart

 

By:

Mike Gray

Title:

Deputy Director

Vaccines and Host-Pathogen Biology

 

Title:

Chief Operating Officer and

Chief Financial Officer

 

 

 

 

 

 

 

 

 

 

8/6/2018

 

August 8, 2018

Date

 

 

Date

 

 

 

 

 

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GRANT AGREEMENT

Investment ID OPP1189138

 

ATTACHMENT A

GRANT AMOUNT AND REPORTING & PAYMENT SCHEDULE

 

GRANT AMOUNT

The Foundation will pay You the total grant amount specified in the Reporting &
Payment Schedule below. The Foundation’s Primary Contact must approve in writing
any Budget cost category change of more     than 10%.

 

REPORTING & PAYMENT SCHEDULE

Payments are subject to Your compliance with this Agreement, including Your
achievement, and the Foundation’s approval, of any applicable targets,
milestones, and reporting deliverables required under this Agreement. The
Foundation may, in its reasonable discretion, modify payment dates or amounts
and will notify You of any such changes in writing.

 

REPORTING

You will submit reports according to the Reporting & Payment Schedule using the
Foundation’s templates or forms, which the Foundation will make available to You
and which may be modified from time to time.  For a progress or final report to
be considered satisfactory, it must demonstrate meaningful progress against the
targets or milestones for that investment period. If meaningful progress has not
been made, the report should explain why not and what adjustments You are making
to get back on track. Please notify the Foundation’s Primary Contact if You need
to add or modify any targets or milestones. The Foundation must approve any such
changes in writing. You agree to submit other reports the Foundation may
reasonably request.

 

ACCOUNTING FOR PERSONNEL TIME

You will track the time of all employees, contingent workers, and any other
individuals whose compensation will be paid in whole or in part by Grant Funds.
Such individuals will keep records (e.g., timesheets) of actual time worked on
the Project in increments of sixty minutes or less and brief descriptions of
tasks performed. The Foundation acknowledges that You have offered the
Foundation the opportunity to review copies of the records maintained by such
individuals for work on the Project through June 30, 2018, and the Foundation
agrees that the descriptions of tasks performed in such records comply with the
foregoing requirements. You will report actual time worked consistent with those
records in Your progress and final budget reports. You will submit copies of
such records to the Foundation upon request.

 

REPORTING & PAYMENT SCHEDULE

Investment

Period

Target, Milestone, or Reporting

Deliverable

Due By

 

Payment Date

 

Payment Amount

(U.S.$)

 

Countersigned Agreement

 

Within [**] days

after receipt of

countersigned

Agreement

$1,137,292.00

Start Date to

End Date

Final Report

Within [**]

days of End

Date

 

 

Total Grant Amount

$1,137,292.00

 

3 of 22

 

 

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GRANT AGREEMENT

Investment ID OPP1189138

 

ATTACHMENT B

TERMS & CONDITIONS

 

This Agreement is subject to the following terms and conditions.

 

  PROJECT SUPPORT

 

PROJECT DESCRIPTION AND CHARITABLE PURPOSE

The Foundation is awarding You this grant to carry out the project described in
the Proposal Narrative and Results Framework and Tracker (collectively,
“Project”) in order to further the Charitable Purpose. The Foundation, in its
discretion, may approve in writing any request by You to make non-material
changes to the Proposal Narrative and/or Results Framework and Tracker.

 

  MANAGEMENT OF FUNDS

 

USE OF FUNDS

You may not use funds provided under the Agreement (“Grant Funds”) for any
purpose other than the Project. You may not use Grant Funds to reimburse any
expenses You incurred prior to the Start Date; provided, however, that the
Foundation hereby approves using Grant Funds to reimburse expenses specifically
included in the Budget incurred by You prior to the Start Date. At the
Foundation’s request, You will repay any portion of Grant Funds and/or Income
that the Foundation determines in its discretion was used or committed in
material breach of this Agreement.

 

INVESTMENT OF FUNDS

You must invest Grant Funds in highly liquid investments with the primary
objective of preservation of principal (e.g., interest-bearing bank accounts or
a registered money market mutual fund) so that the Grant Funds are available for
the Project. Together with any progress or final reports required under this
Agreement, You must report the amount of any currency conversion gains (or
losses) and the amount of any interest, or other income generated by the Grant
Funds (collectively, “Income”). Any Income must be used for the Project.

 

SEGREGATION OF FUNDS

You must maintain Grant Funds in a physically separate bank or a separate
bookkeeping account maintained as part of Your financial records and dedicated
to the Project.

 

  GLOBAL ACCESS

 

GLOBAL ACCESS COMMITMENT

You will conduct and manage the Project and the Funded Developments in a manner
that ensures Global Access. Your Global Access commitments will survive the term
of this Agreement. “Funded Developments” means the products, services,
processes, technologies, materials, software, data, other innovations, and
intellectual property resulting from the Project (including modifications,
improvements, and further developments to Background Technology). “Background
Technology” means any and all products, services, processes, technologies,
materials, software, data, or other innovations, and intellectual property
created by You or a third party prior to or outside of the Project used as part
of the Project. “Global Access” means: (a) the knowledge and information gained
from the Project will be promptly and broadly disseminated; and (b) the Funded
Developments will be made available and accessible at an affordable price (i) to
people most in need within Developing Countries, or (ii) in support of the U.S.
educational system and public libraries, as applicable to the Project.

 

To further define Your Global Access commitments, You will work with the
Foundation to develop, by the time of completion of Phase II clinical trials,
and execute a manufacturing and supply plan that will enable to be met the
reasonably expected demand in Developing Countries for any Products (defined
below).  The expected demand will be determined by the Foundation and You based
upon review of the Foundation’s target markets for the applicable product and
other relevant considerations, including cost-effectiveness.  The price of the
relevant Products in Developing Countries will be such that the Products are
affordable to low income individuals in the Developing Countries, and in no case
would the price charged by You to the relevant procurer or distributor of such
Products exceed Actual Production Costs (defined below) plus 10%.  For clarity,
You will

4 of 22

 

 

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in no event be required to offer the applicable Product to a procurer or
distributor at a price that would be less than Actual Production Costs.  The
manufacturing and supply plan could involve the use of manufacturing partners
and support from donors, and the specific level and allocation of funding
responsibilities in such plan will be decided as mutually agreed in good faith
in writing by the parties based on a fair allocation of the expected benefits
between Developing Countries and developed countries.  The Foundation will have
the right to inspect Your records to verify the Actual Production Costs.  These
commitments do not apply to sales of Products used outside of the Developing
Countries.

 

For purposes of the preceding paragraph, “Product” means any anti-respiratory
syncytial virus (RSV) monoclonal antibody (mAb) optimized by You or on Your
behalf in the course and as a result of performance of the Project (as any such
optimized anti-RSV mAb may be further optimized by You or on Your behalf after
completion of the Project); and “Actual Production Costs” means, with respect to
a Product, (a) Your recognized cost of goods sold as calculated in accordance
with Your usual and customary accounting methods, which are in accordance with
GAAP, minus (b) the amount of any funding provided by the Foundation or any
Foundation-supported Entity directly allocable to the production, supply and
distribution of such Product (except to the extent such funding has been
deducted from the cost of goods sold as calculated under the foregoing
clause (a)).

 

LICENSE TO THE FOUNDATION

For the purpose of achieving Global Access, You grant the Foundation a
nonexclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid up,
sublicensable license to: make, use, sell, offer to sell, import, distribute,
copy, modify, create derivative works, publicly perform and display the Funded
Developments, and any Background Technology incorporated into a Funded
Development or required to use a Funded Development; in each case, for the sole
benefit of people in Developing Countries. You and the Foundation agree and
acknowledge that the license granted in this section does not include the right
to sell Funded Developments for end use outside of the Developing Countries and
that no such sales are authorized under this license.  In the event You
demonstrate to the satisfaction of the Foundation that Global Access can best be
achieved without such a license (or a license of different scope) such as by the
provision of a Global Access Strategy satisfactory to the Foundation, the
Foundation and You will make good faith efforts to modify or terminate this
license, as appropriate.

 

PUBLICATION

Consistent with Your Global Access commitments, if the Project description
specifies Publication or Publication is otherwise requested by the Foundation,
You will seek prompt Publication of any Funded Developments consisting of data
and results. “Publication” means publication in a peer-reviewed journal or other
method of public dissemination specified in the Project description or otherwise
approved by the Foundation in writing. Publication may be delayed for a
reasonable period for the sole purpose of seeking patent protection, provided
the patent application is drafted, filed, and managed in a manner that best
furthers Global Access. If You seek Publication in a peer-reviewed journal, such
Publication shall be under “open access” terms and conditions consistent with
the Foundation’s Open Access Policy available at:
www.gatesfoundation.org/How-We-Work/General-Information/Open-Access-Policy,
which may be modified from time to time. Nothing in this section shall be
construed as requiring Publication in contravention of any applicable ethical,
legal, or regulatory requirements. You will mark any Publication of any Funded
Development subject to this clause with the appropriate notice or attribution,
including author, date and copyright (e.g.,  © 20<> <Name>).

 

INTELLECTUAL PROPERTY REPORTING

During the term of this Agreement and for 5 years after, You will submit upon
request annual intellectual property reports related to the Funded Developments,
Background Technology, and any related agreements using the Foundation’s
templates or forms, which the Foundation may modify from time to time.

 

DATA ACCESS

The Foundation believes the requirement that the knowledge and information
gained from the Project be promptly and broadly disseminated extends to data and
datasets generated through the Project. During the term of this Agreement, You
will make cleaned datasets available to the Foundation upon request within a
reasonable period of time after they are generated, and for internal Foundation
use only. Following the End Date, You will make all cleaned datasets available
to the Foundation, upon request and for internal Foundation use only. Unless
otherwise agreed with the Foundation, You will make all data generated under the
Project available to the public in a manner and under conditions mutually agreed
to in good faith between You and

5 of 22

 

 

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the Foundation. Public dissemination of data and datasets may be delayed for a
reasonable period for the sole purpose of seeking patent protection, provided
the patent application is drafted, filed, and managed in a manner that best
furthers Global Access. Nothing in this section shall be construed as requiring
the dissemination or release of data in contravention of any applicable ethical,
legal, or regulatory requirements.

 

  SUBGRANTS AND SUBCONTRACTS

 

SUBGRANTS AND SUBCONTRACTS

You may not make subgrants under this Agreement. You have the exclusive right to
select subcontractors to assist with the Project.

 

RESPONSIBILITY FOR OTHERS

You are responsible for (a) all acts and omissions of any of Your trustees,
directors, officers, employees, subgrantees, subcontractors, contingent workers,
agents, and affiliates assisting with the Project, and (b) ensuring their
compliance with the terms of this Agreement.

 

  PROHIBITED ACTIVITIES

 

ANTI-TERRORISM

You will not use funds provided under this Agreement, directly or indirectly, in
support of activities (a) prohibited by U.S. laws relating to combating
terrorism; (b) with persons on the List of Specially Designated Nationals
(www.treasury.gov/sdn) or entities owned or controlled by such persons; or (c)
in or with countries or territories against which the U.S. maintains
comprehensive sanctions (currently, Cuba, Iran, Syria, North Korea, and the
Crimea Region of Ukraine), including paying or reimbursing the expenses of
persons from such countries or territories, unless such activities are fully
authorized by the U.S.  government under applicable law and specifically
approved by the Foundation in its sole discretion.

 

ANTI-CORRUPTION; ANTI-BRIBERY

You will not offer or provide money, gifts, or any other things of value
directly or indirectly to anyone in order to improperly influence any act or
decision relating to the Foundation or the Project, including by assisting any
party to secure an improper advantage. Training and information on compliance
with these requirements are available at www.learnfoundationlaw.org.

 

POLITICAL ACTIVITY AND ADVOCACY

You may not use Grant Funds to influence the outcome of any election for public
office or to carry on any voter registration drive. You may not use Grant Funds
to support lobbying activity or to otherwise support attempts to influence
local, state, federal, or foreign legislation. Your strategies and activities,
and any materials produced with Grant Funds, must comply with applicable local,
state, federal, or foreign lobbying law. You agree to comply with lobbying,
gift, and ethics rules applicable to the Project.

 

  PUBLICITY

 

PUBLICITY BY THE FOUNDATION

The Foundation may include information about the award of this grant, including
Your name, in its periodic public reports and may make such information
available on its website and as part of press releases, public reports,
speeches, newsletters, tax returns, and other public disclosures.

 

PUBLICITY BY YOU

You must obtain the Foundation’s prior written approval before: (a) issuing a
press release or other public announcement regarding this grant; and (b) any
other public use of the Foundation’s name or logo. Please email Your request to:
grantee.comms@gatesfoundation.org two weeks in advance to provide the Foundation
an opportunity to review and comment. Detailed guidelines are available at:
www.gatesfoundation.org/grantseeker/documents/guidelines_communications_for_grantees.doc.

 

PUBLICITY BY OTHERS

You and Your subgrantees, subcontractors, contingent workers, agents, or
affiliates may not state or otherwise imply to third parties that the Foundation
directly funds or otherwise endorses their activities.

 

6 of 22

 

 

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  OTHER

 

LEGAL ENTITY AND AUTHORITY

You confirm that: (a) You are an entity duly organized or formed, qualified to
do business, and in good standing under the laws of the jurisdiction in which
You are organized or formed; (b) You are not an individual (i.e., a natural
person) or a disregarded entity (e.g., a sole proprietor or sole-owner entity)
under law; (c) You have the right to enter into and fully perform this
Agreement; and (d) Your performance will not violate any agreement or obligation
between You and any third party. You will notify the Foundation immediately if
any of this changes during the term of this Agreement.

 

COMPLIANCE WITH LAWS

In carrying out the Project, You will comply with all applicable laws,
regulations, and rules and will not infringe, misappropriate, or violate the
intellectual property, privacy, or publicity rights of any third party.

 

COMPLIANCE WITH REQUIREMENTS

You will conduct, control, manage, and monitor the Project in compliance with
all applicable ethical, legal, regulatory, and safety requirements, including
applicable international, national, local, and institutional standards
(“Requirements”). You will obtain and maintain all necessary approvals,
consents, and reviews before conducting the applicable activity. As a part of
Your annual progress report to the Foundation, You must report whether the
Project activities were conducted in compliance with all Requirements.

 

If the Project involves:

 

a.

any protected information (including personally identifiable, protected health,
or third-party confidential), You will not disclose this information to the
Foundation without obtaining the Foundation’s prior written approval and all
necessary consents to disclose such information;

 

b.

children or vulnerable subjects, You will obtain any necessary consents and
approvals unique to these subjects; and/or

 

c.

any trial involving human subjects, You will adhere to current Good Clinical
Practice as defined by the International Council on Harmonisation (ICH) E-6
Standards (or local regulations if more stringent) and will obtain applicable
trial insurance.

 

Any activities by the Foundation in reviewing documents and providing input or
funding does not modify Your responsibility for determining and complying with
all Requirements for the Project.

 

RELIANCE

You acknowledge that the Foundation is relying on the information You provide in
reports and during the course of any due diligence conducted prior to the Start
Date and during the term of this Agreement. You represent that the Foundation
may continue to rely on this information and on any additional information You
provide regarding activities, progress, and Funded Developments.

 

INDEMNIFICATION

If the Project involves clinical trials, trials involving human subjects,
post-approval studies, field trials involving genetically modified organisms,
experimental medicine, or the provision of medical/health  services
(“Indemnified Activities”), You will indemnify, defend, and hold harmless the
Foundation and its trustees, employees, and agents (“Indemnified Parties”) from
and against any and all demands, claims, actions, suits, losses, damages
(including property damage, bodily injury, and wrongful death), arbitration and
legal proceedings, judgments, settlements, or costs or expenses (including
reasonable attorneys’ fees and expenses) (collectively, “Claims”) arising out of
or relating to the acts or omissions, actual or alleged, of You or Your
employees, subgrantees, subcontractors, contingent workers, agents, and
affiliates with respect to the Indemnified Activities. You agree that any
activities by the Foundation in connection with the Project, such as its review
or proposal of suggested modifications to the Project, will not modify or
waive  the Foundation’s rights under this paragraph. An Indemnified Party may,
at its own expense, employ separate counsel to monitor and participate in the
defense of any Claim. Your indemnification obligations are limited to the extent
permitted or precluded under applicable federal, state or local laws, including
federal or state tort claims acts, the Federal Anti-Deficiency Act, state
governmental immunity acts, or state constitutions. Nothing in this Agreement
will constitute an express or implied waiver of Your governmental and sovereign
immunities, if any.

 

INSURANCE

You will maintain insurance coverage sufficient to cover the activities, risks,
and potential omissions of the

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Project in accordance with generally-accepted industry standards and as required
by law. You will ensure Your subgrantees and subcontractors maintain insurance
coverage consistent with this section.

 

  TERM AND TERMINATION

 

TERM

This Agreement commences on the Start Date and continues until the End Date,
unless terminated earlier as provided in this Agreement. The Foundation, in its
discretion, may approve in writing any request by You for a no-cost extension,
including amending the End Date and adjusting any affected reporting
requirements.

 

TERMINATION

The Foundation may modify, suspend, or discontinue any payment of Grant Funds or
terminate this Agreement if: (a) the Foundation is not reasonably satisfied with
Your progress on the Project; (b) there are significant changes to Your
leadership or other factors that the Foundation reasonably believes may threaten
the Project’s success; (c) there is a change in Your control; (d) there is a
change in Your tax status; or (e) You fail to comply with this Agreement.

 

RETURN OF FUNDS

Any Grant Funds, plus any Income, that have not been used for, or committed to,
the Project upon expiration or termination of this Agreement, must be returned
promptly to the Foundation.

 

MONITORING, REVIEW, AND AUDIT

The Foundation may monitor and review Your use of the Grant Funds, performance
of the Project, and compliance with this Agreement, which may include onsite
visits to assess Your organization’s governance, management and operations,
discuss the Project and Your finances, and review relevant financial and other
records and materials. In addition, the Foundation may conduct audits, including
onsite audits, at any time during the term of this Agreement, and within four
years after Grant Funds have been fully spent. Any onsite visit or audit shall
be conducted at the Foundation’s expense, following reasonable prior written
notice, during normal business hours, and no more than once during any 12-month
period.

 

INTERNAL OR THIRD PARTY AUDIT

If during the term of this Agreement You are audited by your internal audit
department or by a third party and such audit identifies any deficiencies
relevant to the management of the Project, You will provide the audit report to
the Foundation upon request, including the management letter and a detailed plan
for remedying any deficiencies observed (“Remediation Plan”), as relevant to the
management of the Project. The Remediation Plan must include (a) details of
actions You will take to correct any deficiencies observed, and (b) target dates
for successful completion of the actions to correct the deficiencies; in each
case, as relevant to the management of the Project.

 

RECORD KEEPING

You will maintain complete and accurate accounting records regarding Your use of
the Grant Funds and copies of any reports submitted to the Foundation relating
to the Project. You will retain such records and reports for 4 years after Grant
Funds have been fully spent. At the Foundation’s request, You will make such
records and reports available to enable the Foundation to monitor and evaluate
how Grant Funds have been used or committed.

 

SURVIVAL

A Party’s obligations under this Agreement will be continuous and survive
expiration or termination of this Agreement as expressly provided in this
Agreement or otherwise required by law or intended by their nature.

 

  GENERAL

 

ENTIRE AGREEMENT AND AMENDMENTS

This Agreement contains the entire agreement of the Parties and supersedes all
prior and contemporaneous agreements concerning its subject matter. Except as
specifically permitted in this Agreement, no modification, amendment, or waiver
of any provision of this Agreement will be effective unless in writing and
signed by authorized representatives of both Parties.

 

NOTICES AND APPROVALS

Written notices, requests, and approvals under this Agreement must be delivered
by mail or email to the other

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Party’s primary contact specified on the Agreement Summary & Signature Page, or
as otherwise directed by the other Party.

 

SEVERABILITY

Each provision of this Agreement must be interpreted in a way that is
enforceable under applicable law. If any provision is held unenforceable, the
rest of the Agreement will remain in effect.

 

ASSIGNMENT

You may not assign, or transfer by operation of law or court order, any of Your
rights or obligations under this Agreement without the Foundation’s prior
written approval. This Agreement will bind and benefit any permitted successors
and assigns.

 

COUNTERPARTS AND ELECTRONIC SIGNATURES

Except as may be prohibited by applicable law or regulation, this Agreement and
any amendment may be signed in counterparts, by facsimile, PDF, or other
electronic means, each of which will be deemed an original and all of which when
taken together will constitute one agreement. Facsimile and electronic
signatures will be binding for all purposes.

 

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ATTACHMENT C

DEVELOPING COUNTRIES

 

“Developing Countries” means the following list of countries, which includes (i)
countries eligible for GAVI support as of 2016, (ii) countries in the process of
transitioning out of GAVI support in 2016, and (iii) Botswana, Brazil,
Philippines, South Africa and Thailand. “Developing Countries” also means any
countries reasonably requested by the Foundation that are part of the
Foundation’s strategies to which the Company consents in writing, such consent
not to be unreasonably withheld and subject to the consent of Adimab, as
applicable.

 

•

 

Afghanistan

•

 

Guinea

•

 

Pakistan

•

 

Angola

•

 

Guinea Bissau

•

 

Philippines

•

 

Armenia

•

 

Guyana

•

 

Papua New Guinea

•

 

Azerbaijan

•

 

Haiti

•

 

Rwanda

•

 

Bangladesh

•

 

India

•

 

São Tomé e Príncipe

•

 

Benin

•

 

Indonesia

•

 

Senegal

•

 

Bolivia

•

 

Kenya

•

 

Sierra Leone

•

 

Botswana

•

 

Kiribati

•

 

Solomon Islands

•

 

Burkina Faso

•

 

Korea, DPR

•

 

Somalia

•

 

Burundi

•

 

Kyrgyz Republic

•

 

Republic of Sudan

•

 

Cambodia

•

 

Lao PDR

•

 

South Africa

•

 

Cameroon

•

 

Lesotho

•

 

South Sudan

•

 

Central African Republic

•

 

Liberia

•

 

Tajikistan

•

 

Chad

•

 

Madagascar

•

 

Tanzania, United Republic of

•

 

Comoros

•

 

Malawi

•

 

Thailand

•

 

Congo,Dem Republic of

•

 

Mali

•

 

Timor Leste

•

 

Côte d’Ivoire

•

 

Mauritania

•

 

Togo

•

 

Cuba

•

 

Moldova

•

 

Uganda

•

 

Djibouti

•

 

Mozambique

•

 

Uzbekistan

•

 

Eritrea

•

 

Myanmar

•

 

Vietnam

•

 

Ethiopia

•

 

Nepal

•

 

Yemen

•

 

Gambia

•

 

Nicaragua

•

 

Zambia

•

 

Georgia

•

 

Niger

•

 

Zimbabwe

•

 

Ghana

•

 

Nigeria

 

 

 

 

 

 

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[gnhmo5dgyo1b000002.jpg]

 

Grant Proposal Narrative

We appreciate your interest in submitting a proposal to the Bill & Melinda Gates
Foundation and we thank you for working with us throughout the proposal process.
Your designated foundation contact will continue to work collaboratively with
you as you prepare your proposal to help you understand the connection between
the foundation's relevant program strategy and the proposed project, as well as
to respond to any questions you might have over the course of this process. You
are encouraged to communicate with your program officer to make sure that your
efforts are aligned with the proposal requirements and that you are not
expending unnecessary time or energy in this process.

Answer all of the questions in this Proposal Narrative template and submit it to
your foundation program officer for review and collaborative discussion. Due to
tax, legal, and reporting requirements, all proposals must be submitted in
English. The proposal must be submitted in Word, as PDFs will not be accepted.

This is a proposal shaping document and not a commitment by the foundation to
fund the work.

General Information

Proposal Title

Respiratory Syncytial Virus (RSV) Program: Optimization Proposal

Requested Amount (U.S.$)

$1,137,292

Investment Duration (Months)

6

Total Project Cost (U.S.$)

$1,137,292

 

Opportunity ID

OPP1189138

 

Prospective Grantee Information

Organization Legal Name1

Arsanis, Inc.

Organization Doing Business as

 

Primary Contact Name

[**]

Mailing Address

Primary Contact Title

[**]

   Street Address 1

890 Winter Street

Primary Contact Email

[**]

   Street Address 2

Suite 230

Primary Contact Phone

[**]

   Street Address 3

 

Feedback Contact2

[**]

   City

Waltham

Feedback Email2

[**]

   State / Province

Massachusetts

Authorized Signer Name

Mike Gray

   Zip / Postal Code

02451-1472

Authorized Signer Title

CFO and CBO

   Country

United States

Authorized Signer Email

mike.gray@arsanis.com

 

Website (if applicable)

www.arsanis.com

 

1 Legal Name will be used in the agreement and should match the name on the bank
account that receives the grant funds (assuming fully executed agreement).

2 Feedback Contact/Email: The full name and email of the contact whom foundation
staff queries for various surveys.

Tax Status (if known and applicable)

Refer to Tax Status Definitions

Non-Exempt Organization - C Corporation

Organization’s Total Revenue for Most Recent Audited Financial Year (U.S.$)

$0

U.S. Employer Identification Number (EIN) (if applicable)

27-3181608

 

Submission Information

Date Submitted

10 April, 2018

Submitted by same as above

Yes

Submitted by Contact Name

 

Submitted by Contact Email

 

Submitted by Contact Title

 

Submitted by Contact Phone

 

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Proposal Details

The Foundation is prohibited from conducting or funding any lobbying or
political campaign activities, as these terms are specifically defined under
U.S. tax law. Unlike many of our grantees/vendors who may engage in limited
lobbying, the Foundation cannot lobby or fund any lobbying activities carried
out by its grantees/vendors. We request that you please review the information
at the following link: Foundation Funds and Advocacy, to assess whether any of
your proposed activities may constitute lobbying as defined by the IRS. If so,
you should revise your proposal accordingly prior to submission.

1.Executive Summary

Provide a brief summary of the investment.

Program Vision

Arsanis endeavors to collaborate with the Bill & Melinda Gates Foundation (BMGF)
to develop and commercialize a safe, effective, globally-accessible parenteral
monoclonal antibody product for the prevention of respiratory syncytial virus
(RSV) infection in all newborns and potentially adults who could benefit from
prophylactic intervention. Our guiding principles for this program will support
BMGF’s Global Access commitments for an RSV monoclonal antibody (mAb).

The Arsanis team is deeply experienced in the research, development, and
commercialization of infectious disease products (including RSV therapeutics)
and mAbs, and as such is an attractive partner for BMGF’s RSV initiatives.

Describe the charitable purpose of this work by completing the statement “This
grant will be used [to …].” Please limit to one sentence, begin with “to” and do
not include a period at the end. Example: “This grant will be used [to fund new
schools and assist other organizations in the design of new schools]”

Further develop a safe, effective, potent, highly manufacturable, and durable
monoclonal antibody for the prevention of respiratory syncytial virus infection.

 

2.Problem Statement

Describe the problem, why it is a problem, and who is impacted by the problem.
What specific elements of the problem is this investment trying to address?

The only product approved for the prevention of RSV infection is MedImmune’s
Synagis® (palivizumab), a humanized mAb (IgG) directed against the RSV
glycoprotein F. While effective in reducing RSV hospitalization rate in
high-risk neonates, the global availability of Synagis is highly-restricted in
developed countries and absent in the developing world for a variety of reasons
including cost, dosing regimen, manufacturing capacity, and product
stability.  This is a critical problem in the developing world, where RSV is
responsible for over 30 million cases of acute lower respiratory infection and
200,000 deaths per year.

The development of a safe, effective, and globally-accessible product for the
prevention of RSV infection has proven to be elusive over the years. Only one
mAb product candidate is in clinical development, MEDI8897 (MedImmune), an
anti-RSV mAb that targets glycoprotein F, which has the potential to show higher
efficacy, and be administered by a more convenient dosing regimen than is
currently the case with Synagis.

 

3.Scope and Approach

Describe the scope and approach of the proposed work. This should be a narrative
description of the principal results the investment would achieve and how those
results relate to the problem described above (rather than a list of outcomes
and outputs.) Note: You will provide a list of outcomes and outputs in the
Results Framework.

Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 4 pages were omitted. [**]

 

4.Risk Mitigation

As needed, describe any significant risks to the success of this project and how
you plan to address them.

[**]

 

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5.How We’ll Work Together

This question is intended to begin the dialogue on how foundation staff would
work with you to achieve the intended outcomes. Topics could include minimal
staff support, any specific issues that would likely need on-going discussion,
regular communications, or other information to help establish mutual
expectations and assist with implementing the proposed work.

Team meetings planned for [**]. Additional ad hoc teleconferences and email
communication as needed.

 

6.Geographic Areas to Be Served

List all countries and sub-regions/states that would benefit from this work and
associated dollar amounts. If areas to be served include the United States,
indicate city and state. Add more rows as needed. More information about
Geographic Areas to Be Served can be found here.

Location

Foundation Funding (U.S.$)

World

$1,137,292

 

$

 

$

 

7.Geographic Location of Work

List all countries and sub-regions/states where this work would be performed and
associated dollar amounts. If location of work includes the United States,
indicate city and state. Add more rows as needed. More information about
Geographic Location of Work can be found here.

Location

Foundation Funding (U.S.$) (DIRECT COST ONLY)

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

 

8.Global Access and Open Access

In order to establish that the projects we fund are charitable and will have a
positive impact on the intended beneficiaries of our work, the foundation
requires the projects it funds be conducted and managed in a manner that ensures
Global Access and Open Access.

“Global Access” is a foundation policy requiring that: (a) the knowledge and
information gained from the project will be promptly and broadly disseminated;
and (b) the Funded Developments will be made available and accessible at an
affordable price (i) to people

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most in need within developing countries, or (ii) in support of the U.S.
educational system and public libraries, as applicable to the project.

“Funded Developments” means the products, services, processes, technologies,
materials, software, data, other innovations, and intellectual property
resulting from the project, including modifications, improvements, and further
developments to Background Technology.

“Background Technology” means any and all products, services, processes,
technologies, materials, software, data, or other innovations, and intellectual
property created by You or a third party prior to or outside of the project used
as part of the project.

Additional information about Global Access (including examples and case studies)
can be found at http://globalaccess.gatesfoundation.org/.

“Open Access” is a foundation policy that sets the requirements, terms and
conditions for publication of Funded Developments in a peer-reviewed journal.
Additional Information on the foundation’s Open Access Policy for peer-reviewed
publications and underlying data can be found at
www.gatesfoundation.org/How-We-Work/General-Information/Open-Access-Policy.
Note: the foundation will pay directly for reasonable fees to effect publication
on “open access” terms; such fees should not be included in the project budget
(See the Open Access Policy FAQs for further detail).

a)

Knowledge and Information

Describe how the knowledge and information gained from the project will be
promptly and broadly disseminated (including how you will comply with the
foundation’s Open Access Policy, discussed above).

Arsanis will promptly and broadly disseminate the output of Funded Developments
in compliance with the Open Access Policy and Arsanis internal policies.  Our
primary approaches are publication in peer-reviewed journals and presentations
(e.g. abstracts, oral sessions) at scientific congresses.  In some
circumstances, timing of disclosures may be gated by the need to provide for
relevant intellectual property protections prior to such disclosures.

b)

Funded Developments (Indicate “not applicable,” as appropriate)

 

i.

Describe any Funded Developments that may ultimately result from the project,
including any Background Technology that will be used or incorporated in the
proposed project. If applicable, briefly explain how the Funded Developments
will be made available and accessible at an affordable price to the intended
beneficiaries. The use of commonly-available, off-the-shelf products (such as
Microsoft Excel, Adobe, etc.) need not be disclosed.

Funded Developments that may ultimately result from the project include:

•Monoclonal antibody (mAb) drug candidates targeting RSV infection

•Pre-clinical data and regulatory filings that support the initiation of human
studies of these mAbs

•Manufacturing know-how for the production of GMP mAb drug product

•Intellectual property (including patents and know-how) covering the mAbs

Background technology that may be incorporated in the project includes:

•Arsanis know-how related to the discovery and optimization of mAbs

•RSV mAb sequences (patents and know-how) that may be in-licensed by Arsanis
from Adimab, LLC upon exercise of the Adimab license described below

•Technologies (patents and know-how) related to the optimization of RSV mAbs
in-licensed by Arsanis from third parties

Technologies (patents and know-how) related to the manufacture of RSV mAbs
in-licensed by Arsanis from third parties

 

ii.

Please confirm that you will make the Funded Developments – including any
Background Technology incorporated into or required to use the Funded
Developments – available to achieve the proposed project’s goals and Global
Access. If you foresee any obstacles to achieving Global Access (e.g., third
party rights, broad access, time frame, affordability) please briefly summarize
the obstacles and the specific steps that you will take to address them.  

Arsanis will make the Funded Developments available to achieve the project’s
goals and Global Access as agreed upon with BMGF.

Potential obstacles include:

[**].

c)

Intellectual Property

Please indicate which, if any, of the following applies to your project:

 

__X__

Creation of Funded Developments will likely involve new IP rights (Note:
copyrights in works intended to be published in accordance with the Open Access
Policy need not be disclosed);

 

__X__

Use of Background Technology requires access to existing IP rights; or

 

__X__

For-Profit entities are engaged in the project.

If any of the above are present, please complete an Intellectual Property (IP)
Report:  

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Note: For login purposes, please use the email address to which this Proposal
Narrative was sent. To delegate permissions to another member of your project
team, or for any questions regarding the IP Report, please contact
GlobalAccess@gatesfoundation.org.

If none of the above apply, please acknowledge by typing N/A: ____

 

9.Advocacy and Lobbying

While the foundation funds a broad range of advocacy activities, US law
prohibits foundation funds from being earmarked to support direct or grassroots
lobbying communications. Describe how this project will be conducted in
compliance with these rules, as summarized in the Advocacy Guidelines Handout,
and any other relevant local, state, or non-US lobbying laws. If foundation
grant funds will be earmarked to influence policies, budgets, innovations,
frameworks, action plans, etc., that could require a legislative vote, explain
how such “legislative” activities will be conducted in accordance with the
applicable rules and exceptions. Your explanation should address both direct and
grassroots communications. If this investment does not include advocacy
activities, indicate in the space below.

Arsanis will not use Foundation funds for this program to support direct or
grassroots lobbying communications. All funds will be used for the project as
described in this grant proposal.

 

10.Conduct and Control of the Project

In answering the questions in this section, please consider all Project
activities, such as those involving: confidential or protected information
(including personally identifiable information or protected health information);
the inclusion of children or vulnerable populations; research involving human
subjects; clinical trials; post-approval studies; field trials; experimental
medicine; provision of medical services (diagnostic, prophylactic or treatment);
product development; use of genetically modified organisms, human tissue,
animals, radioactive isotopes, pathogenic organisms, recombinant nucleic acids,
select agents or toxins (www.selectagents.gov), dual-use technology
(http://export.gov/regulation/eg_main_018229.asp), or any substance, organism,
or material that is toxic or hazardous; use of aircraft, unmanned vehicle
systems, drones or satellites; and the import, export, transfer, approvals,
consents, records, data, specimens, images, and materials related to any of the
forgoing.   

 

1.

Please confirm that your organization:

 

a)

will maintain the expertise necessary to conduct, control, manage, and monitor
all aspects of the Project in compliance with all applicable ethical, legal,
regulatory, and safety requirements including applicable international,
national, state, local, and institutional, school district or school network
standards and policies and is responsible for determining and complying with
these requirements and standards;

 

b)

will not disclose any confidential or protected information to the Foundation
without obtaining prior written approval from the foundation and all necessary
consents to disclose such information;

 

c)

acknowledges that any activities by the Foundation in reviewing documents,
providing input or funding does not modify your organization’s responsibility
for determining and complying with all applicable ethical, legal, regulatory,
and safety requirements for the Project in all places;

 

d)

is a government agency, public institution or multilateral organization or will
otherwise maintain insurance coverage sufficient to cover the activities, risks,
and potential omissions of the Project in accordance with generally-accepted
standards and as required by law (for instance, general, professional, clinical
trial, product liability, medical malpractice, workers' compensation, or
otherwise);

 

e)

will not transfer any biological materials, chemicals, reagents, hazardous
materials or the like to the Foundation.

Confirmed __X__

Not confirmed ____ (please explain)

 

Complete if you are a Global Health Applicant:

 

2.

Does the Project involve any of the following: clinical trial, other trial
involving human subjects, post-approval study, experimental medicine, field
trial of genetically modified organisms, or the provision of medical/health
services?  

No __X__

Yes ____ (If yes, please list all approvals and consents required for each site
and describe the timeframe in which your organization will acquire the necessary
approvals and consents.)

 

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3.

Please identify the name of the entity that will be the sponsor/responsible
party of any clinical trials, studies involving human subjects, experimental
medicine studies, post-approval studies, products, or regulatory filings
contemplated by the Project.  Note that the Foundation will not serve as the
sponsor/responsible party nor accept delegation of any of these
responsibilities. If the Project will not involve such activities, please
indicate not applicable or N/A below.

Arsanis, Inc.

Complete if you are a U.S. Program Applicant:

 

4.

Does the Project involve regulated human subject research?  

No __X__

Yes ____ (If yes, please identify the name of the entity that will be conducting
such research and please describe any consents, approvals or waivers needed or
obtained to the extent such are necessary for compliance with applicable law.)

 

Delete this text before sending:

OPTIONAL QUESTIONS (11-21)

PO to select which optional questions below (11-21) to include. At a minimum,
include any questions identified by the Risk Profile, Investment Development
Plan, and GCM/Business Partner feedback. PC to remove questions that are not
applicable before sending, but remember the Reporting & Payment Schedule will
need to be completed and discussed with grantee prior to sending them the grant
agreement.

 

11.Data Access

We anticipate this investment, if funded, would generate datasets that may be of
interest to the foundation and/or to the field if made publicly
available.  Please describe any datasets that will be generated as part of this
investment. Specifically address when and how the datasets would be made
available to the foundation and/or to the public, in what form or format, and
any anticipated costs to your organization. Additional information about Data
Access can be found here.  

[**]

Budget Narrative

The purpose of the budget narrative is to supplement the information provided in
the excel-based budget template by justifying how the budget cost elements are
necessary to implement project activities and accomplish target outcomes. The
budget narrative is a tool to help foundation staff fully understand the
budgetary needs of the project and is an opportunity to provide descriptive
information about the costs, drivers, and risks that can’t be easily
communicated in the budget template. Together, the budget narrative and budget
template should provide a complete quantitative and qualitative description that
supports the proposed budget. The description provided in the budget template
should be very brief. Please use this budget narrative to provide a thorough
description of your budget and only complete questions that are relevant to your
grant proposal.

For Global Development, Global Health and Global Policy and Advocacy related
grants: If your proposal includes any sub-contracts and/or sub-grants greater
than $1 million USD, please complete a separate budget template and narrative
for each organization.

For U.S. Programs, Communications and Family Interest related grants: If your
proposal includes any sub-contracts and/or sub-grants greater than $250,000 USD,
please complete a separate budget template and narrative for each organization.

 

1.Summary

Please explain the major cost drivers and how costs relate to planned activities
and target outcomes. Also explain any potential risks in spending as budgeted
and any plans to mitigate those risks.

If budgeting by outcomes, or additional dimension, please explain the major cost
drivers per outcome or other relevant dimension.

[**].

 

2.Personnel and Benefits

Personnel: Provide a brief explanation of personnel budgeted, including
responsibilities as they relate to the grant. Also include assumptions made for
any staff budgeted which are to-be-hired, including salary estimates for these
personnel.

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[**].

Benefits: Describe the components of the benefits (column R of the “Budget
Details” sheet) included with the salary costs. For example: pension, health
insurance, expatriate costs, etc.

[**].

 

3.Travel

Provide rationale for the travel budgeted and assumptions used to determine
appropriate number of trips and personnel required. Also include a brief
rationale for how travel costs were estimated.

In person meeting with Foundation in [**]

 

4.Consultants

Provide a brief description of the work to be performed by consultants in
support of the overall project and describe any expenses that have been
included.

[**]

 

5.Capital Equipment

Provide a brief justification and description of any items required for the
project with a unit cost of greater than $5,000 (USD) and a useful life of more
than one year.

N/A

 

6.Other Direct Costs

Provide a brief description and rationale for other direct costs required,
including cost assumptions used to develop the budget for these costs.

Direct costs include [**].

 

7.Sub-awards

List all sub-grantees or sub-contractors involved in this investment. Add more
rows as needed.

Name

Corporate Entity Name (if applicable)

Mailing Address

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

[**]

If separate budgets are required (see above), please also submit a separate
budget template and narrative for each sub-award.

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Describe the work each organization is going to perform as well as the rationale
for each organization chosen to participate on this project as a sub-grantee or
sub-contractor. If organizations are TBD, include the assumptions used to
estimate cost for the sub-award and the process and timeline you will be using
to select these organizations.  

Note: You will be required to submit the sub-award budget once final.

 

 

8.Indirect Cost Rate

Briefly explain the indirect cost rate being charged on this project and the
rationale and assumptions behind it.

The indirect cost rate applied to this project is [**].

 

9.Currency Exchange

Briefly describe any foreign currency exchange exposure with this investment.
Which costs included in the budget are exposed to exchange risk? How much do
these costs total?

Approximately $[**].

[**]

 

10.Other Sources of Support for this Project

If you are requesting funding from the foundation for only a portion of this
project and will depend on funds from other sources, please describe your
contingency plans if full project funding does not become available. If you have
applied for funding from other sources which overlap with the funding requested
in this proposal, please indicate the nature and timing of that potential
funding. Any expected in-kind contributions (e.g. drug donations, personnel
time) should be included in the description.

NOTE: Names of the other sources and their expected dollar (U.S.$) contributions
should be included on the ‘Financial Summary & Reporting’ sheet of the budget in
the Funding Plan table.

 

 

11.Other

Please feel free to use this section to provide any other commentary or
information that helps to describe and justify the budget request presented.
This may include assumptions and rationale behind indirect costs, risks,
anomalies or other assumptions foundation staff should be aware of when
reviewing the budget.

Total project spend incurred in Q1’18 was approximately $[**]. By category:

•[**]

Privacy and Non-Confidentiality Notice

The foundation is required by the IRS to publish a list of its grants. We may
also provide a general description of our grants and contracts on our web sites,
in press releases, and in other marketing materials. Subject to the foundation’s
Privacy Policy, the foundation may also share information you provide to us
(either orally or in writing) with third parties, including external reviewers,
key partners and co-funders. This document is subject to the foundation’s Terms
of Use.

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Results Framework and Tracker (Short Form)

Use this form to capture and report on investment outputs. The Results Framework
& Results Tracker will be developed collaboratively by you and your foundation
program officer to finalize an agreed upon outputs schedule.

General Information

Investment Title

Respiratory Syncytial Virus (RSV) Program: Optimization Proposal

Program Officer

[**]

Opportunity/Contract ID

OPP1189138

Prospective Grantee Information

Organization Legal Name

Arsanis Inc

Primary Contact Name

[**]

Primary Contact Email

[**]

Primary Contact Title

[**]

Primary Contact Phone

[**]

Submission Information

Date Submitted

11 April 2018

Submitted by same as above

Yes

Submitted by Contact Name

 

Submitted by Contact Email

 

Submitted by Contact Title

 

Submitted by Contact Phone

 

 

1.Primary Investment Outcomes

Define the ultimate or overall change(s) in technologies, systems, populations
or behaviors the investment seeks to achieve in the context of the project
timeframe; tell us what success is for this investment. (If section is
pre-populated, edit as needed.)

Note: Primary investment outcomes may not be applicable for all investments. In
these cases, please leave the space below blank.

The primary investment outcome for the project timeframe is [**]. The long-term
objective of the program is the development of a safe, effective, potent, highly
manufacturable, and durable monoclonal antibody for the prevention of
respiratory syncytial virus infection.

 

2.Investment Outputs

Provide a list of outputs (the goods, services, deliverables, or events produced
during an investment) that will be tracked. This is not meant to be an
exhaustive list of activities, but rather outputs that inform whether the
project is on track. The Foundation and grantee/vendor will determine together
which outputs will be tied to payments. (If section is pre-populated, edit as
needed.)

Output Number

Output Description

Assuming a January 1st, 2018 start date

Target Completion Date

Actual Completion Date

Payment Contingency

1

[**]

[**]

 

 

2

[**]

[**]

 

 

3

 

 

 

 

4

 

 

 

 

 

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3.Grantee/Vendor Comments

Use this section to provide comments about the outputs/deliverables above
including variances on completion dates, additional context, etc. Be sure to
include the date and specific deliverable referred to in the comment.

[**]

Privacy and Non-Confidentiality Notice

The foundation is required by the IRS to publish a list of its grants. We may
also provide a general description of our grants and contracts on our web sites,
in press releases, and in other marketing materials. Subject to the foundation’s
Privacy Policy, the foundation may also share information you provide to us
(either orally or in writing) with third parties, including external reviewers,
key partners and co-funders. This document is subject to the foundation’s Terms
of Use.

 

 

 

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[gnhmo5dgyo1b000003.jpg]

 

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Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. A total of 10 pages were omitted. [**]

 

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