Exhibit 10.3
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
COLLABORATIVE RESEARCH &
LICENSE AGREEMENT
between
LIPID SCIENCES,
INC.
and
ELANCO ANIMAL
HEALTH
Portions of this agreement, marked by asterisks
(***), have been omitted pursuant to a request for confidential
treatment. The omitted information has been filed separately
with the Securities and Exchange Commission
This COLLABORATIVE RESEARCH & LICENSE
AGREEMENT (the “Agreement”) is effective from the
Effective Date by and between:
LIPID SCIENCES, INC.
(“ Lipid Sciences
”), a publicly-traded Delaware corporation, having a place of
business at 7068 Koll Center Parkway - Suite 401, Pleasanton, CA
94566;
and
ELI LILLY AND COMPANY
, an Indiana corporation, operating
through its Elanco Animal Health division and having a principal
place of business at 2001 W. Main Street, Greenfield, Indiana 46140
(“ Elanco ”).
INTRODUCTION
A.
WHEREAS, Lipid Sciences and/or its Affiliate(s) have developed
proprietary technology for, and are the owners and/or exclusive
licensees of patents claiming, delipidation-based methods and
systems for the production of treatments for viral or bacterial
infections, among other ailments (“Immunological
Products”).
B.
WHEREAS, Lipid Sciences and/or its Affiliate(s) have facilities and
personnel that enable it to design and develop various kinds of
Immunological Products.
C.
WHEREAS, Lipid Sciences and/or its Affiliate(s) possess know-how,
expertise and intellectual property rights pertaining to the design
and development of these Immunological Products.
D.
WHEREAS, Elanco is engaged in the research, development, marketing,
manufacturing and distribution of animal health products for use
in, on or near live animals.
E.
WHEREAS, Elanco desires to design, develop and manufacture certain
Immunological Products for use in, on or near live
animals.
F.
WHEREAS, Lipid Sciences and/or its Affiliate(s) desire to
collaborate with Elanco in the development of one or more
Immunological Products for animal health applications, subject to
the terms and conditions set forth herein.
NOW THEREFORE, in consideration of
the foregoing premises and the following mutual covenants and other
good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, the Parties agree as
follows:
ARTICLE I
1.1
Interpretation . In this Agreement, unless the context
otherwise requires, a reference to:
(a)
a paragraph, section, exhibit or
schedule is a reference to a paragraph, section, exhibit or
schedule to this Agreement;
2
Portions of this agreement, marked by asterisks
(***), have been omitted pursuant to a request for confidential
treatment. The omitted information has been filed separately
with the Securities and Exchange Commission
(b)
any document includes a reference to
that document (and, where applicable, any of its provisions) as
amended, novated, supplemented or replaced from time to
time;
(c)
a statute or other law includes
regulations and other instruments under it and consolidations,
amendments, re-enactments or replacements of any of
them;
(d)
the singular includes the plural and
vice versa, except as it regards the definitions in Sections 1.27
and 1.28 of this Agreement;
(e)
a Party, person or entity
includes:
(i)
an individual, firm, company,
corporation, association, trust, estate, state or agency of a
state, government or government department or agency, municipal or
local authority and any other entity, whether or not incorporated
and whether or not having a separate legal personality;
and
(ii)
an employee, agent, successor,
permitted assign, executor, administrator and other representative
of such party, person or entity;
(f)
one gender includes the
other;
(g)
“written” and “in
writing” include any means of reproducing words, figures or
symbols in a tangible and visible form;
(h)
a month or year is a reference to a
calendar month or calendar year, as the case may be; and
(i)
individuals or persons include
companies and other corporations and vice versa.
1.2
“Affiliate” means any corporation or other entity
that controls, is controlled by, or is under common control with a
Party to the Agreement. A corporation or other entity will be
regarded as in control of another corporation or entity if the
latter corporation or entity owns or directly or indirectly
controls more than fifty percent (50%) of the voting stock or other
ownership interest of the former corporation or other entity, or if
the latter corporation or entity possesses, directly or indirectly,
the power to direct or cause the direction of the management and
policies of the former corporation or other entity or the power to
elect or appoint fifty percent (50%) or more of the members of the
governing body of the former corporation or other entity. An
Affiliate will be bound under this Agreement in the same manner as
if it were a party hereto.
1.3
“Agreement” means this formal legal document if
ultimately signed by both Parties, effective as of the Effective
Date.
1.4
“Confidential Information” means all know-how,
trade secrets, technical information, specifications, data,
formulae, intellectual property or software of a Party relating to
or arising out of this Agreement including, without
limitation:
3
Portions of this agreement, marked by asterisks
(***), have been omitted pursuant to a request for confidential
treatment. The omitted information has been filed separately
with the Securities and Exchange Commission
(a)
all communications between the
Parties or information of whatever kind whether recorded or not
and, if recorded, in whatever medium, relating to or arising out of
the Product Development Plan, the Design & Development Program,
the Improvements, the Lipid Sciences Patent Rights, the Elanco
Patent Rights, the Elanco Inventions, Lipid Sciences Inventions,
Lipid Sciences Technology, Elanco Technology or the Agreement,
whether disclosed prior to or after entering into the
Agreement;
(b)
any information that the Party
indicates in writing is information of a confidential nature or
which is marked “confidential”; and
(c)
all copies of the communications,
information, notes, reports and documents in whatever form referred
to in paragraph (a) or (b) of this definition.
1.5
“Design & Development Program” means the
work performed by Lipid Sciences and Elanco and/or their respective
Affiliate(s) in accordance with the Product Development Plan as
revised from time to time as provided in the Agreement.
1.6
“ECI” or “Employment Cost
Index” means the “Private Industry, Compensation,
12-Month Percent Change, Not Seasonally Adjusted - ECU10002A”
with respect to Total Compensation in Private Industry for All
Workers (annual rate or average of the relevant year’s four
calendar quarters if not annual), Series Id ECU10002A; using 2007
as the base year for purposes of indexing within the context of
this Agreement, as published by the U.S. Bureau of Labor Statistics
and available at the following URL:
http://data.bls.gov/cgi-bin/surveymost?ec, or its successor
site.
1.7
“Effective Date” means the last date of
signature on the Agreement.
1.8
“Elanco Compound” means one or more active
ingredients directly resulting from Lipid Sciences Technology that
is selected by Elanco for development and commercialization of
Product(s) and/or New Product(s).
1.9
“Elanco Invention” means any Invention by Elanco
and/or its Affiliates (other than a joint invention) that is
discovered, made, or conceived and reduced to practice during or as
a result of the Design & Development Program. For
clarity, any invention by Elanco and/or its Affiliates outside the
Design & Development Program will be solely owned by Elanco
and/or its Affiliates.
1.10
“Elanco Patent Rights” means any and all Patent
Rights owned and/or controlled by Elanco during the term of the
Agreement.
1.11
“Elanco Technology” means Technology, including
know-how and trade secrets, owned and/or controlled by Elanco as of
the Effective Date of the Agreement and/or developed during the
term of the Agreement.
4
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
1.12
“Field” means all applications and uses of the
Lipid Sciences Technology and Lipid Sciences Patent Rights for
Products. For clarity, “Field” does not include
any human applications or uses.
1.13
“First Commercial Sale” of any Product(s) and/or
New Product(s) means the first sale for use by an end-user customer
of such Product(s) and/or New Product(s) in a country.
1.14
“First Payment” means the first payment, e.g., a
technology access fee or a payment made due to a first Regulatory
Agency submission, made by Elanco to Lipid Sciences pursuant to the
payment terms of Article V for any Product(s) and/or New
Product(s).
1.15
“GxP” means compliance with all relevant
Regulatory Agency requirements for Good Clinical Practices, Good
Laboratory Practices, and Good Manufacturing Practices.
1.16
“Immunological Products” means: proprietary
delipidation-based methods and systems for the production of
treatments for viral or bacterial infections, among other ailments,
of which Lipid Sciences and/or its Affiliate(s) are the owners
and/or exclusive licensees having the right to enforce and
sublicense.
1.17
“Improvements” means: (a) any modification
of Lipid Sciences Technology, Elanco Technology or an Elanco
Compound, provided such modification, if unlicensed, would infringe
one or more Valid Claims of Lipid Sciences Patent Rights or Elanco
Patent Rights; and (b) any beneficial modification of a component
or material useful in a Product(s) and/or New Product(s); in each
of (a) and/or (b) for use in the Field or New Field, which is
reduced to practice within the term of the Agreement.
1.18
“Invention” means patentable ideas and/or
discoveries conceived by one or more employee(s) or agent(s) of
Lipid Sciences or Elanco, which arise under and during the term of
this Agreement. “Sole Invention” means an
Invention discovered, made, or conceived and reduced to practice
solely by Lipid Sciences employee(s) or agent(s) or solely by
Elanco employee(s) or agent(s). “Joint
Invention” means an Invention discovered, made, or
conceived and reduced to practice jointly by Lipid Sciences
employee(s) or agent(s) and Elanco employee(s) or
agent(s).
1.19
“Joint Patent Rights” means Patent Rights to a
Joint Invention.
1.20
“Lipid Sciences Invention” means any Invention
by Lipid Sciences and/or its Affiliates (other than a joint
invention) that is discovered, made, or conceived and reduced to
practice during or as a result of the Design & Development
Program. For clarity, any invention by Lipid Sciences and/or
its Affiliates outside the Design & Development Program will be
solely owned by Lipid Sciences and/or its Affiliates.
1.21
“Lipid Sciences Patent Rights” means any and all
Patent Rights owned and/or controlled by Lipid Sciences and/or its
Affiliates in the Field or New Field during the term of the
Agreement.
5
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
1.22
“Lipid Sciences Technology” means Technology,
including know how and trade secrets, owned and/or controlled by
Lipid Sciences as of the Effective Date of the Agreement and/or
developed during the term of the Agreement, and includes, without
limitation, Immunological Products and delipidation-based
immunological technology for use in, on or for animals.
1.23
“Net Sales” means, with respect to a Product(s)
and/or New Product(s), the gross amount invoiced by Elanco
(including an Elanco Affiliate) or any sublicensee thereof to
unrelated Third Parties, excluding any sublicensee, for Product(s)
and/or New Product(s) in the Territory, less the
following:
(a)
Customary trade, quantity and cash
discounts allowed;
(b)
Third Party Agent commissions,
discounts, refunds, rebates, chargebacks, retroactive price
adjustments and similar allowances, limited to reasonable
adjustments and allowances which effectively reduce the net selling
price;
(c)
Actual Product(s) and/or New
Product(s) returns or allowances;
(d)
Any tax imposed on the sale,
delivery or use of the Product(s) and/or New Product(s), including,
without limitation, sales, use, excise or value added taxes, but
excluding any tax on income; and
(e)
Any other similar and customary
deductions.
Such amounts will be determined from
the books and records of Elanco, Elanco Affiliates and/or
sublicensee(s) (as applicable), maintained in accordance with U.S.
Generally Accepted Accounting Principles (also known as
“GAAP” ) or, in the case of sublicenses, such
similar accounting principles, consistently applied. Elanco
further agrees in determining such amounts, it will use
Elanco’s then-current standard procedures and methodology,
including Elanco’s then current standard exchange rate
methodology for the translation of foreign currency sales into U.S.
Dollars or, in the case of sublicensees, such similar methodology,
consistently applied.
1.24
“New Field” means all applications and uses of
the Lipid Sciences Technology and Lipid Sciences Patent Rights for
New Products. For clarity, “New Field” does not include
any human applications or uses.
1.25
“New Product(s)” means any *** that
incorporates, uses or implements Lipid Sciences Technology and/or
Lipid Sciences Patent Rights and that is ultimately sold by or for
Elanco inside the New Field in the Territory, whether such
embodiment was in existence prior to the effective date of a
collaborative research and commercialization agreement, or is
developed or improved under that agreement. ***
1.26
“Notice” means the definition provided in
Section 11.7.
1.27
“Parties” means Lipid Sciences and
Elanco.
1.28
“Party” means Lipid Sciences or
Elanco.
6
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
1.29
“Patent Rights” means rights under all patents,
provisional and non-provisional, owned or controlled by the Parties
(including all reissues, extensions, substitutions, confirmations,
re-registrations, re-examinations, re-validations, patents of
addition, supplementary protection certificates or the equivalents
thereof) and under all provisional and non-provisional patent
applications (including, without limitation, all continuations,
continuations-in-part and divisionals thereof), in each case,
claiming an Invention which is necessary or useful for the design,
development, testing, use, manufacture or sale of a Product(s)
and/or New Product(s) that results from the Agreement.
1.30
“POC Study” means the initial proof-of-concept
study that Elanco will conduct at its expense as consideration for
the rights granted under this Agreement. The criteria for
establishing this POC Study are described in Exhibit A of this
Agreement. As additional consideration to Lipid Sciences for
entering into this Agreement, Elanco will also provide technical
advice regarding the detailed design and scope of this POC Study,
at no charge to Lipid Sciences.
1.31
“Primary Contact Person” will be the respective
individuals designated by Lipid Sciences and Elanco, as noted in
Exhibit C, who will be responsible for the day-to-day interactions
between the Parties related to the Design & Development Program
and the management of the day-to-day operations of the Design &
Development Program. Each Party may change its Primary
Contact Person upon Notice to the other Party.
1.32
“Product” means any *** that incorporates, uses
or implements Lipid Sciences Technology and/or Lipid Sciences
Patent Rights, whether such embodiment was in existence prior to
the Effective Date, or is developed or improved under the
Agreement. ***
1.33
“Product Development Plan” means the written
development plan for Product(s) and/or New Product(s) (including a
corresponding budget), as amended from time to time by the
Parties.
1.34
“Program Year” means each twelve (12) calendar
month period during the term of the Design & Development
Program, except in the first Program Year in which case the Program
Year will not be twelve (12) calendar months in length, but will be
the period from the Effective Date to 31-December-2007.
1.35
“Reasonable Commercial Efforts” means effort,
expertise and resources normally used by the Party in the
development and/or commercialization of a compound or product owned
or controlled by such Party which is of similar market potential at
a similar stage in its development or product life, taking into
account issues of safety and efficacy, product profile, the
competitiveness of the marketplace, the proprietary position of the
compound or product, the regulatory structure involved, the
profitability of the applicable products, and other relevant
factors.
1.36
“Regulatory Agency” means any one of the U.S.
Department of Agriculture (USDA); Environmental Protection Agency
(EPA); Food and Drug Administration (FDA); Food Safety and
Inspection Service (FSIS); or any counterparts thereof in
jurisdictions outside of the USA.
1.37
“Steering Committee” means the joint committee
composed of representatives of Lipid Sciences and Elanco, as
described in the Agreement.
7
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
1.38
“Technology” means written specifications,
sketches, drawings, schematics, prototypes, methods, protocols,
know-how, trade secrets, all proprietary data, information,
inventions, regulatory submissions or other intellectual property
of any kind, excluding Patent Rights, to the extent necessary or
useful for the research, development and commercialization of
Product(s) and/or New Product(s) in the Field or New Field, and any
other information or tangible material and any data related thereto
that is useful in the Field or New Field.
1.39
“Territory” means worldwide.
1.40
“Third Party” means any entity, including any
natural person, other than Lipid Sciences or Elanco and their
respective Affiliates.
1.41
“Valid Claim” means either (a) a claim of an
issued and unexpired patent which has not been held permanently
revoked, unenforceable or invalid by a decision of a court or other
governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable through
re-examination, reissue or disclaimer or otherwise; or (b) a claim
of a pending patent application, which claim was filed in good
faith and has not been abandoned or finally disallowed without the
possibility of appeal or refiling of said application.
ARTICLE II
2.1
License Grant. Subject to the terms of the Agreement,
Lipid Sciences and its Affiliates hereby grant to Elanco and its
Affiliates the sole and exclusive license under Lipid Sciences
Technology, Lipid Sciences Patent Rights, Lipid Sciences Inventions
and Lipid Sciences Improvements in the Field and Territory to
research, develop, make, have made, use, sell, offer for sale,
import and sub-license, Product(s).
2.2
Rights Retained by Lipid Sciences. Lipid Sciences
retains the sole and exclusive right outside the Field in the
Territory to use for any purpose any Lipid Sciences Technology,
Lipid Sciences Patent Rights, Lipid Sciences Inventions and Lipid
Sciences Improvements (including, without limitation, to research,
develop, make, have made, use, sell, offer for sale, import and
license products). For clarity, Elanco and its Affiliates
cannot research, develop, make, have made, use, sell, offer for
sale, import or sublicense any Lipid Sciences Technology, Lipid
Sciences Inventions, Lipid Sciences Improvements or Lipid Sciences
Patent Rights outside the Field, unless Elanco and/or its
Affiliates enter into a separate agreement with Lipid Sciences
and/or its Affiliates. Furthermore:
(a)
no license or other rights are
granted to Lipid Sciences to Elanco Technology, Elanco Patent
Rights or Elanco Inventions, except solely for the benefit of
Elanco and its Affiliates;
(b)
no license or other rights are
granted to Elanco to Lipid Sciences Technology, Lipid Sciences
Patent Rights or Lipid Sciences Inventions, except as provided in
this Agreement;
8
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
(c)
Elanco and its Affiliates
acknowledge that, as of the Effective Date, no license or other
rights are necessary to be granted, or are granted, to Lipid
Sciences by Elanco and its Affiliates for the purposes of the
Agreement, except to the extent disclosed in writing by Elanco to
Lipid Sciences prior to work commencing under the Product
Development Plan or under the Design & Development Program for
the development of the Product in the Field; and
(d)
Lipid Sciences and its Affiliates
acknowledge that, as of the Effective Date, no license or other
rights are necessary to be granted, or are granted, to Lipid
Sciences by Third Parties for the purposes of the Agreement, except
to the extent disclosed in writing by Lipid Sciences to Elanco
prior to work commencing under the Product Development Plan or
under the Design & Development Program for the development of
the Product in the Field.
2.3
Rights Reverting to Lipid Sciences . If any Product(s)
and/or New Product(s) or indication reverts to Lipid Sciences
pursuant to Section 5.1, then Lipid Sciences will have the
exclusive right inside the Field or New Field and within the
Territory to use any Lipid Sciences Technology, Lipid Sciences
Patent Rights, Lipid Sciences Improvements and Lipid Sciences
Inventions to develop, make, have made, use, sell, import or
sub-license Product(s) and/or, as applicable, New
Product(s).
2.4
Sublicenses. Subject to the other provisions of the
Agreement, Elanco shall have the sole right to sublicense any and
all rights licensed to Elanco under Section 2.1. Any such
sublicense by Elanco shall be consistent with the terms of the
Agreement, and shall include an obligation for each such
sublicensee to comply with the applicable obligations of Elanco set
forth in the Agreement.
2.5
Trademarks. Elanco will be free to use and to register
in any trademark office any trademark for use with a Product(s)
and/or New Product(s) in its sole discretion, except for trademarks
proprietary to Lipid Sciences and its Affiliates. Elanco will
own all right, title and interest in and to any such trademark in
its own name during and after the term of the Agreement, except for
trademarks proprietary to Lipid Sciences and its
Affiliates.
ARTICLE III
3.1
Formation and Composition. A joint committee comprised of
four (4) members, two (2) named representatives of each of Elanco
and Lipid Sciences (the “Steering Committee” )
is being appointed pursuant to this Agreement. Each Party has
provided the other Party in writing with the name, title, e-mail
address, telephone number and facsimile number of their respective
Steering Committee members and such information is set forth in
Exhibit C. The Steering Committee will meet as needed, but
not less than once each quarter during the term of the Design &
Development Program. Such meetings will be at such times
agreed to by Lipid Sciences and Elanco, and will alternate between
the offices of the Parties unless the Parties otherwise agree, or
will be in such other form (e.g., telephone or video conference) as
the members of the Steering Committee will agree.
3.2
Steering Committee Functions and Powers. The Steering
Committee will be responsible for the direction and overall
supervision and management of the Design &
9
Portions of this agreement, marked
by asterisks (***), have been omitted pursuant to a request for
confidential treatment. The omitted information has been
filed separately with the Securities and Exchange
Commission
Development Program consistent with
each Party’s internal policies and procedures. The
principal functions of the Steering Committee will be
to:
(a)
create Design & Development
Program(s) and Product Development Plan(s);
(b)
monitor the progress and results
achieved under the Design & Development Program and to revise,
as necessary, the Product Development Plan;
(c)
foster the collaborative
relationship between the Parties;
(d)
facilitate the transfer, development
and commercialization of technology in accordance with the
Agreement;
(e)
determine potential New Products,
identify and approve the development of New Products;
and
(f)
such other functions as agreed by
the Parties.
A Party may change one or more of
its representatives to the Steering Committee at any time.
Members of the Steering Committee may be represented at any meeting
by another member of the Steering Committee, or by a deputy.
Either Party may permit additional employees and consultants to
attend and participate (on a non-voting basis) in the Steering
Committee meetings, subject to the confidentiality provisions of
the Agreement.
3.3
Decisions of the Steering Committee. A quorum of the
Steering Committee will be present at any meeting of the Steering
Committee if at least two (2) representatives of each Party are
present at such meeting in person or by telephone or
videoconference. If a quorum exists at any meeting, a
unanimous vote of the members of the Steering Committee present at
such meeting is required to take any action on behalf of the
Steering Committee, with the exception of any actions taken
pursuant to Section 3.4.
3.4
Elanco’s Right to Control Commercialization.
Notwithstanding the responsibilities and duties of the Steering
Committee, Elanco will have the right to choose Product(s) and/or
New Product(s) for development and commercialization, including
formulation, means of administration and other factors that appear
most promising for further development. Promptly upon making
a selection, Elanco will notify the Steering Committee in
writing.
3.5
New Products. Elanco has the first option right to
commercialize all applications and uses of the Lipid Sciences
Technology and Lipid Sciences Patent Rights for New Products
(“Option Right”). Therefore, if Elanco determines
that, pursuant to the results obtained by the Design &
Development Program, Product(s) and/or New Product(s) are
commercially viable, upon the payment of relevant payments
described in Article V of this Agreement, Elanco and its Affiliates
will have the sole and exclusive license under Lipid Sciences
Technology, Lipid Sciences Patent Rights, Lipid Sciences Inventions
and Lipid Sciences Improvements in the New Field and Territory to
research, develop, make, have made, use, sell, offer for sale,
import and sub-license the New Product(s) in accordance with the
following terms:
3.5.1. Exercise of Option Right
by Elanco. To exercise the Option Right, Elanco shall
propose to the Steering Committee, in writing, the
commercialization of any New Product(s); within three (3) months,
the Steering Committee shall complete a Product Development Plan
for said New Product(s). Provided Elanco pays the additional
payments described in Article V of this
10