Exhibit 10.1
REDACTED COPY—CONFIDENTIAL
TREATMENT REQUESTED
Redacted portions have been marked with brackets containing
asterisks ([***]). The redacted portions are subject to a
request for confidential treatment and have been filed separately
with the Securities and Exchange Commission.
COLLABORATION AND LICENSE
AGREEMENT
THIS Collaboration and License
Agreement (“ Agreement ”) is made effective as
of February 9, 2007 (the “ Effective Date ”) by
and among SELECT Vaccines Limited, ABN 25 062 063 692, a company
incorporated under the laws of Victoria, Australia having its
principal place of business at Suite 15, 545 St Kilda Road,
Melbourne, Victoria 3004, Australia (“ SVL ”),
and Hepgenics Pty Ltd, ABN 44 104 360 714, a wholly owned
subsidiary of SELECT VACCINES, a company incorporated under the
laws of Victoria, Australia having its principal place of business
at Suite 15, 545 St Kilda Road, Melbourne, Victoria 3004, Australia
(together with SELECT VACCINES, “ SELECT ”), and
AVANT Immunotherapeutics, Inc., a Delaware corporation having a
principal place of business located at 119 Fourth Avenue, Needham,
Massachusetts 02494-2725 USA (“ AVANT ”).
SELECT and AVANT are each hereafter referred to individually as a
“Party” and together as
“Parties”.
A. SELECT and AVANT desire to
collaborate in the discovery and development of vaccines against
certain disease targets, whereby SELECT will use its virus-like
particle technologies to generate and characterize such vaccines
and AVANT will use its expertise with respect to
vaccines.
B. AVANT wishes to obtain from
SELECT a license to the Licensed Subject Matter (hereinafter
defined) and resulting discoveries on the terms set forth
herein.
C. SELECT and AVANT desire to
initiate the performance of the above-described activities by
SELECT and AVANT and therefore agree to undertake the foregoing,
all under the terms and conditions set forth in this
Agreement.
NOW, THEREFORE, in consideration of
the mutual covenants and premises contained below, the parties
agree as follows:
1 - DEFINITIONS
As used in this Agreement, the
following terms have the meanings indicated:
1.1
“ Affiliate ” means any business controlled by a
Party, any business entity that controls a Party, or any business
entity that is controlled by a business entity that is controlled
by a Party. For the purposes of this Section 1.1,
“control” means (i) the direct or indirect ownership of
fifty percent (50%) or more of the voting stock or other voting
interests or interest in the profits of the Party, or (ii) the
ability to otherwise control or direct the decisions of board of
directors or equivalent governing body thereof.
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1.2
“ Antigen ” means at least one protein
(including any glyco- or lipo-protein), carbohydrate, compound or
other composition, and any fragment, peptide or epitope thereof, or
combinations thereof that is capable of eliciting an immune
response in humans.
1.3
“ AVANT Collaboration Invention ” means a
Collaboration Invention created or conceived solely by AVANT
Employees.
1.4
“ Business Day ” means a day other than a
Saturday or Sunday on which banking institutions both in Melbourne,
Australia and Boston, Massachusetts are open for
business.
1.5
“ Candidate Antigen ” means an Antigen that the
JRC reasonably believes shows, or is likely to show, scientific and
commercial promise for the development of a Vaccine
Product.
1.6
“ Collaboration Invention ” shall mean any
discovery, invention, Know-How, Patent or trade secret, including
an Improvement in the Licensed Subject Matter, first conceived or
made in the performance of the Research Program.
1.7
“ Collaboration Patent ” means a Patent that
discloses or claims a Collaboration Invention.
1.8
“ Combination Product ” means a Licensed Product
that includes at least one additional active ingredient other than
a VLP. Drug delivery vehicles, adjuvants, and excipients
shall not be deemed to be “active ingredients”, except
in the case where such delivery vehicle, adjuvant, or excipient is
recognized as an active ingredient in accordance with
21 C.F.R. 210.3(b)(7).
1.9
“ Control ” means possession of the ability to
grant a license or sublicense as provided for herein without
violating the terms of any agreement or other arrangements with any
Third Party.
1.10
“ Dollars ” or “ $ ” means
U.S. dollars.
1.11
“ Employee ” means (i) an employee or agent of a
Party or Affiliate, and (ii) with respect to SELECT, an employee of
the Burnet Institute as long as a service agreement exists between
SELECT and the Burnet Institute that contains standard
confidentiality and intellectual property assignment obligations
requiring the Burnet Institute to cause that employee to agree to
observe and comply with the confidentiality and intellectual
property assignment obligations within that agreement.
1.12
“ Excluded Antigen ” means an Antigen associated
with [***].
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1.13
“ FDA ” means the United States Food and Drug
Administration or its equivalent governmental, regulatory or health
authorities in any jurisdiction.
1.14
“ First Commercial Sale ” means the first
commercial sale of a Licensed Product by AVANT or any of its
Sublicensees under this Agreement.
1.15
“ First Licensed Product ” means a Licensed
Product containing a Target Antigen related to influenza virus, as
specified in Appendix B.
1.16
“ FTE ” means an Employee scientist working
full-time on the Research Program, or, an equivalent amount of work
on the Research Program performed by more than one such Employee
scientists. For purposes of this Section 1.15,
“full-time” means not less than one thousand eight
hundred and forty (1,840) hours per year.
1.17
“ Generic Equivalent ” means a Vaccine Product
sold by a Third Party without the consent or approval of AVANT and
SELECT that addresses the same Target Disease as a particular
Licensed Product and (i) the manufacture, use, or sale of such
Vaccine Product would be covered or claimed by one or more claims
within the SELECT Patents or Collaboration Patents but for the fact
that: (a) all such claim(s) are contained within patent
applications, filed in good faith, that have not yet issued, but
have been pending for less than seven (7) years and have not been
withdrawn, cancelled or abandoned, or (b) all such claims are
within patents that have expired or been revoked or determined to
be invalid or unenforceable; or (ii) is sold in a country in which
no SELECT Patents or Collaboration Patents covering the
manufacture, use or sale of such Licensed Product have been
filed.
1.18
“ Improvement ” means all improvements,
enhancements, additions and adaptations to the Licensed Subject
Matter conceived or created by either Party or any of their
respective Affiliates that are sufficiently different to be
separately patentable.
1.19
“ IND ” means an investigational new drug
application filed with the FDA as more fully defined in
21 C.F.R. § 312.3 or its equivalent in any
jurisdiction.
1.20
“ Joint Collaboration Invention ” means a
Collaboration Invention created or conceived jointly by AVANT and
SELECT.
1.21
“ Know-How” means all information and data,
technical information, trade secrets, specifications, instructions,
processes, formulae, expertise and information relating to Licensed
Products including, without limitation: (i) biological, chemical,
pharmacological, biochemical, toxicological, pharmaceutical,
physical and analytical, safety, quality control,
manufacturing,
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preclinical and
clinical data, instructions, processes, formulae, expertise and
information including Technology Rights that are relevant to the
manufacture, use or sale or and /or which may be useful in
studying, testing, developing, producing, formulating or using the
Licensed Products; and (ii) copies of any IND or NDA or other
health registration documents and amendments or supplements thereto
filed with the FDA or other governmental, Regulatory Authority or
health authority in the Licensed Territory and all correspondence
to and from such agency relevant to the Licensed Products
which is known to and/or possessed and /or acquired by a Party or
its Affiliates.
1.22
“ Licensed Field ” means the development and
commercialization of Vaccine Products for human therapeutic and
prophylactic use.
1.23
“ Licensed Product ” means a Vaccine Product
that (i) is covered by or made using Licensed Subject Matter and
(ii) contains a Target Antigen related to a Target
Disease.
1.24
“ Licensed Subject Matter ” means the (i) SELECT
Know-How, (ii) SELECT Patents, and (iii) SELECT’s
interest in any Joint Collaboration Inventions.
1.25
“ Licensed Territory ” means
worldwide.
1.26
“ NDA ” means a New Drug Application and all
supplements filed pursuant to the requirements of the FDA,
including all documents, data and other information which are
necessary for, or included in, FDA approval to market a Licensed
Product as more fully defined in 21 C.F.R. § 314.50
et. seq, or its equivalent in any jurisdiction..
1.27
“ Net Sales ” means, with respect to any
Licensed Product, the gross revenues received from the sale of
Licensed Products by AVANT and its Affiliates for bona fide
sales of such Licensed Product to a Third Party (other than
Sublicensees and AVANT’s Affiliates but including
distributors for resale), less discounts (including cash, quantity
and patient program discounts), retroactive price reductions,
charge-back payments and rebates granted to managed health care
organizations or to federal, state and local governments, their
agencies, and purchasers and reimbursers or to trade customers;
credits or allowances actually granted upon claims, damaged goods
or rejections of such Licensed Product, freight out, postage,
shipping and insurance charges for delivery of such Licensed
Product; and sales and/or use taxes actually paid, including
value-added taxes, or other governmental charges otherwise imposed
upon the billed amount, as adjusted for rebates and refunds, to the
extent not paid by the Third Party, import and/or export duties
actually paid, outbound transportation prepaid or allowed, and
amounts allowed or credited due to returns, including such Licensed
Product returned in connection with recalls or withdrawals (not to
exceed the original
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billing or
invoice amount). Net Sales shall not include any payments
among AVANT, its Affiliates and Sublicensees.
1.28
“ Patent ” means any patent or patent
application, whether domestic or foreign, and all divisions,
provisional applications, continuations, continuations-in-part,
reissues, reexaminations or extensions of any of the foregoing, and
any letters patent that issue on any of the foregoing.
1.29
“ Phase II ” means that portion of the FDA
submission and approval process which provides for the initial
trials of a Licensed Product on a limited number of patients for
the purposes of determining dose and evaluating safety and
immunogenicity in the proposed therapeutic indication as more fully
defined as 21 C.F.R. §213.21(b).
1.30
“ Product Royalty Term” means with respect to
each Licensed Product in a country, the longer of (i) ten (10)
years after the First Commercial Sale of such Licensed Product in
the relevant country, or (ii) the life of Patents that claim the
manufacture, use or sale of such Licensed Product in the relevant
country.
1.31
“ Regulatory Approval ” means, with respect to a
country, any and all approvals, licenses, registrations or
authorizations of any Regulatory Authority necessary to
commercially distribute, sell or market a product in such country,
including, where applicable and as required, (i) pricing or
reimbursement approval in such country, (ii) pre- and
post-approval marketing authorizations (including any prerequisite
manufacturing approval or authorization related thereto),
(iii) labeling approval, and (iv) technical, medical and
scientific licenses.
1.32
“ Regulatory Authority ” means any
supra-national, federal, national, regional, state, provincial or
local governmental regulatory agencies, departments, bureaus,
commissions, councils or other government entities regulating or
otherwise exercising authority with respect to the development,
manufacture or commercialization of biological drug products,
including the FDA, EMEA and Koseisho.
1.33
“ Second Licensed Product ” means a second
Licensed Product (i.e., a Licensed Product that contains a
different Target Antigen that is related to a different Target
Disease than the Target Antigen and Target Disease relating to the
First Licensed Product) chosen by AVANT pursuant to
Section 3.5a of this Agreement and to be specified in Appendix
B hereto.
1.34
“ SELECT Collaboration Invention ” means a
Collaboration Invention created or conceived solely by SELECT
Employees.
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1.35
“ SELECT Know-How ” means Know-How that is
Controlled by SELECT as of the Effective Date or during the term of
this Agreement.
1.36
“ SELECT Patents” means all Patents that are
Controlled by SELECT as of the Effective Date or during the term of
this Agreement, which claim technology that is reasonably necessary
or useful for the testing, developing, producing, formulating,
using or exploiting of the Licensed Product in the Licensed Field,
including those Patents that claim VLPs, Vaccine Products or the
development or commercialization thereof.
1.37
“ Sublicensee” means any Third Party (other than
an Affiliate) licensed by AVANT or its Affiliates to make, sell,
import, export, advertise, promote and otherwise commercialize any
Licensed Product.
1.38
“ Sublicense Fees ” means all compensation
received by AVANT from a Sublicensee that relate specifically to
the grant of a sublicense by AVANT of the rights licensed hereunder
by SELECT to AVANT, including (i) up-front cash payments made
to AVANT in consideration of the sublicense; (ii) the fair market
value of all non-cash consideration received by AVANT from a
Sublicensee, including, without limitation, equity in other
companies, the value of which is to be calculated as the average
closing price for a share of stock from the class of stock involved
for 5 consecutive days preceding the execution of the sublicense
agreement; (iii) any premium over fair market value paid by a
Sublicensee for an equity investment in AVANT; (iv) milestone
payments paid by a Sublicensee; and (v) royalty payments on
sales of Licensed Products received by AVANT from any
Sublicensee. Sublicensee Fees shall not include any of the
following: (a) sponsored research payments; (b) payments
for past research expenditures relating to development of Licensed
Products; (c) payments made for an equity investment in AVANT
by a Sublicensee to the extent that such payments do not exceed the
fair market value of such equity; (d) payments made in
consideration of the manufacture or supply of Licensed Products by
AVANT to the extent that such payments do not exceed the costs of
such manufacture and supply; and (e) loans made to
AVANT.
1.39
“ Target Antigen ” means an Antigen specified in
Appendix B.
1.40
“ Target Disease ” means a disease specified in
Appendix B.
1.41
“ Technology Rights ” means a Party’s
rights in technical information, processes, procedures,
compositions, devices, methods, formulas, protocols, techniques,
software, designs, drawings or data created before the Effective
Date relating to a Party’s technology that are not covered by
Patents but that are necessary for practicing any invention covered
by Patents.
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1.42
“ Third Licensed Product ” means a third
Licensed Product (i.e., a Licensed Product that contains a
different Target Antigen that is related to a different Target
Disease than the Target Antigens and Target Diseases relating to
the First Licensed Product and the Second Licensed Product) chosen
by AVANT pursuant to Section 3.5b of this Agreement and to be
specified in Appendix B hereto.
1.43
“ Third Party ” means any entity other than
SELECT or AVANT, excepting Affiliates of either.
1.44
“ VLP ” means a virus-like particle.
1.45
“ Vaccine Product ” means a vaccine (i)
containing a VLP, or (ii) made using a VLP.
1.46
Terms defined elsewhere in this Agreement .
The following terms are
defined in the applicable Sections of this Agreement:
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a.
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“Agreement”
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Preamble
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b.
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“Confidential
Information”
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Section 10.1
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c.
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“Disclosing Party”
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Section 10.1
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d.
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“Effective Date”
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Preamble
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e.
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“First Milestone”
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Section 4.2
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f.
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“Indemnifying Party”
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Section 8.1
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g.
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“Indemnitees”
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Section 8.1
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h.
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“JRC”
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Section 2.2a
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i.
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“Notice Period”
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Section 7.2
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j.
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“Party” or “Parties”
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Preamble
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k.
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“Receiving Party”
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Section 10.1
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l.
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“Research Program”
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Section 2.1
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m.
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“Research Plan”
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Section 2.1
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n.
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“Research Term”
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Section 2.3a
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“Shares”
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Section 4.1a
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p.
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“Third Party Claim”
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Section 11.4
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q.
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“Third Party
Licenses”
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Section 3.4
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2 - RESEARCH
COLLABORATION
2.1
SELECT and AVANT agree to jointly research and develop Candidate
Antigens and Licensed Products under a research program (the
“ Research
Program ”) in accordance with
the initial research plan set forth in Appendix A (the
“ Research Plan
”). Each
Party shall use diligent efforts to perform its respective
responsibilities under and for the Research Plan, and shall
cooperate with and provide reasonable support to the other Party in
such other Party’s performance of its responsibilities
thereunder.
2.2
Joint Research Committee .
a.
Promptly after the Effective Date, SELECT and AVANT shall establish
a joint research committee (“ JRC ”) to (i) oversee the
Research Program, (ii) establish, plan and coordinate the
activities under the Research Plan, and (iii) facilitate the
exchange of information regarding the Research Program. The
JRC will set specific research goals of the Research Program,
evaluate the results of the Research Program, discuss information
relating to the Research Program and will ensure that there is
appropriate scientific direction for the Research
Program.
b.
Within thirty (30) days following the Effective Date, the JRC will
evaluate the Research Plan and modify it if necessary. The
JRC shall thereafter periodically modify the Research Plan as it
deems necessary.
c.
The JRC shall be comprised of two (2) representatives from each
Party. The chairperson of the JRC shall be designated by
AVANT.
d. If
the JRC fails to reach unanimous agreement on any matter before it
for consideration, representatives of AVANT shall have sole
authority to decide the matter.
e.
Meetings of the JRC shall be held at such times as agreed to by the
Parties (but no less than once each calendar quarter). Such
meetings may be in-person, via videoconference, or via
teleconference, provided that at least one meeting per
calendar year shall be held in person. The location of in-person
JRC meetings will alternate between Needham, Massachusetts, and
Melbourne, Australia, or in such other manner or location as the
Parties mutually agree. SELECT and AVANT shall each bear all
expenses of their respective JRC representatives related to their
participation on the JRC and attendance at JRC meetings. SELECT
will
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provide AVANT
with a proposed agenda for each JRC meeting at least five (5)
Business Days prior to the scheduled meeting date. AVANT shall
record all decisions made, and otherwise take minutes as
appropriate. JRC meeting minutes will be sent to each member
of the JRC for review within five (5) Business Days after a
meeting; such minutes shall be deemed approved by both of the
Parties unless a Party objects to the accuracy of such minutes by
providing written notice to the other Party within ten (10)
Business Days of receipt of such minutes by such Party’s
primary JRC contact. A Party may, with the prior consent of
the other Party (such consent not to be unreasonably withheld or
delayed), invite a reasonable number of Employees, consultants or
scientific advisors to attend a meeting of the JRC, provided,
however, that such attendees shall participate only as observers
and advisors and shall not have a decision-making role. Those
invitees must be bound by appropriate confidentiality
obligations.
2.3
Collaboration Term .
a.
The Research Program begins on the Effective Date and shall
expire two (2) years after the Effective Date, unless extended
as provided below, or unless this Agreement is earlier terminated
by either Party pursuant to the provisions of Section 7 (the
“ Research Term
”). In no
event, however, will the Research Term extend beyond three years
after the date of the First Milestone. Upon the end of the
Research Term, SELECT will not have any obligation to perform any
activities with respect to the development or optimization of
Candidate Targets or Licensed Products.
b.
The Research Program and the Research Term may be extended at the
option of AVANT for two additional one (1) year periods by
providing written notice to SELECT within thirty (30) days of the
then-current expiration date of the Research Term and, thereafter,
by mutual agreement of the Parties.
2.4
SELECT Research Efforts. During the Research Term,
SELECT shall support the research and other activities to be
undertaken by SELECT under the Research Plan and as part of the
Research Program with an annual resource commitment to provide
[***] FTEs. SELECT may not subcontract or outsource any work
or any activities under the Research Plan, except that SELECT may
fulfill its commitment to provide FTEs to the Research Program by
having work performed by Third Party individual contractors or
consultants upon AVANT’s prior written approval (each, a
“ Third Party
FTE ”). As a
condition to obtaining AVANT’S approval with respect to a
Third Party FTE, that individual must: (i) have appropriate
experience and qualifications, (ii) be under SELECT’s direct
supervision and control, (iii) be obligated to observe the
limitations and
9
restrictions
respecting SELECT’s Confidential Information and Know-How
with the same degree and care as required under this Agreement,
(iv) be obligated to assign to SELECT of all the right, title and
interest in and to any intellectual property (and intellectual
property rights) created or discovered by such Third Party
FTE. SELECT is responsible for compliance by such Third Party
FTEs with the terms and conditions of this Agreement. In no
event, shall SELECT be obligated to incur costs in performing
activities under the Research Program in excess of the amounts
provided under Section 2.5.
2.5
Research Program Funding.
a.
AVANT agrees to fund the Research Program at the following
rates:
(1)
During the first year of the Research Program, such funding shall
be [***], which shall be paid in cash to SELECT in advance in equal
installments on a quarterly basis.
(2)
During the second year of the Research Program, such funding shall
be [***], which shall be paid in cash to SELECT in advance in equal
installments on a quarterly basis.
(3)
If AVANT elects to extend the Research Program and Research Term in
accordance with Section 2.3b, the amount of funding shall be
mutually decided by the Parties, taking into account the current
FTE rates and shall be paid in cash to SELECT in advance in equal
installments on a quarterly basis.
b. In
addition to AVANT’s Research Program funding set forth in
Section 2.5a, SELECT shall support the research and other
activities to be undertaken by the FTEs under the Research Plan and
as part of the Research Program with a first-year resource
commitment of [***].
2.6
Limited Use of Research Program Funding.
AVANT’s Research Program funding set forth in Section 2.5a
shall be used by SELECT only in connection with the research and
other activities to be undertaken by the FTEs under the Research
Plan and as part of the Research Program.
2.7
Records.
a.
SELECT will maintain complete and accurate records which are
relevant to (i) work performed by FTEs, and (ii) its
expenditure of Research Program funding under this Agreement.
Such records shall be available for inspection during reasonable
business hours for a period of two (2) years from creation of
individual records for examination at
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AVANT’s
expense and not more often than once each year by AVANT for the
sole purpose of verifying SELECT’s compliance with Section
2.6.
b.
The Parties shall prepare and maintain records of the activities
performed hereunder in sufficient detail and generally in a manner
sufficient for purposes of establishing intellectual property
rights in any inventions conceived of or reduced to practice in
connection with the Research Program.
2.8
Within thirty (30) days after the end of each calendar quarter in
which activities are performed under the Research Plan, SELECT
shall provide to the JRC a written progress report, which report
shall (i) describe the activities SELECT has performed or caused to
be performed under the Research Plan during such calendar quarter,
(ii) evaluate the work performed in relation to the goals of the
Research Plan, and (iii) provide such other information as may be
required by the Research Plan or reasonably requested by the JRC
with respect to SELECT’s activities under the Research
Plan.
3 - LICENSES
3.1
Licenses for Research Program
a.
SELECT grants AVANT a nonexclusive, royalty-free, fully paid-up
worldwide license, with no right to grant sublicenses (except as
set forth in Section 3.3c, under the Licensed Subject Matter solely
to carry out AVANT’s obligations under the Research Plan
during the Research Term.
b.
AVANT grants SELECT a nonexclusive, royalty-free, fully paid-up
worldwide license, with no right to grant sublicenses, under the
AVANT Collaboration Inventions and AVANT’s interest in the
Joint Collaboration Inventions solely for SELECT to carry out its
obligations under the Research Plan during the Research
Term.
3.2
Licenses for Collaboration Patents
a.
SELECT grants to AVANT a nonexclusive, fully paid-up worldwide
license, with the right to sublicense, under any Collaboration
Patents that are owned solely by SELECT.
3.3
License to AVANT for Licensed Products
a.
SELECT hereby grants to AVANT a royalty-bearing, exclusive (even
with respect to SELECT) license under the Licensed Subject Matter
to develop, make, have made, use, offer to sell, sell, have sold
and import Licensed Products within the Licensed Territory for use
within the
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Licensed Field.
This license is subject to (i) the continued effectiveness of this
Agreement and (ii) the rights retained by SELECT to perform its
obligations under the Research Program. As of the Effective
Date, the First Licensed Product is the only Licensed
Product.
b.
AVANT may extend the license granted in this Agreement to any of
its Affiliates if that Affiliate consents to be bound by this
Agreement to the same extent as AVANT, and SELECT approves such
Affiliate. Any approval granted by SELECT under this Section
3.3b must be in writing and must be granted before the
extension.
c.
AVANT may grant sublicenses (through multiple tiers) consistent
with the scope of the rights and licenses granted to AVANT pursuant
to Sections 3.1a or 3.3. AVANT will be
responsi
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