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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:
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(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
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(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:
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(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
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(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:
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(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.
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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:
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(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
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(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:
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(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
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
Agreement, the Option Right shall be deemed to have been
exercised by Elanco, the Option Right shall be deemed to have been
granted to Elanco by Lipid Sciences, and the New Product(s shall be
deemed to have been approved for development by the Steering
Committee.
3.5.2. Termination of Option Right by Elanco. The
Option Right for any New Product terminates sixty (60) days after
Elanco receives Notice from Lipid Sciences that any payment due
under Article V has not been received, provided that, during that
sixty (60) day period, Elanco has not made such payment to Lipid
Sciences. After the Option Right terminates for any New
Product, Lipid Sciences has full right and authority to pursue, or
have others pursue, the research and/or commercialization of the
relevant New Product.
3.5.3. Limitations on Option Right. In order to
effectively manage the development pipeline, if, after exercising
its Option Right(s), Elanco has not made a First Payment for three
(3) New Product(s), Elanco must first obtain the written approval
of the Steering Committee before exercising its Option Right to
commercialize any additional New Product(s).
Notwithstanding Sections 2.1 and 3.5, this Agreement does not
serve to grant to Elanco or its Affiliates a license under Lipid
Sciences Technology, Lipid Sciences Patent Rights, Lipid Sciences
Inventions and Lipid Sciences Improvements to generally use Lipid
Sciences Technology in a field outside the Field or New Field or to
research, develop, make, have made, sell, offer for sale, import
and sub-license products other than Product(s) or New
Product(s).
3.6
Chair. The Steering Committee will be chaired by one
Elanco representative appointed by Elanco for the first Program
Year, then one Lipid Sciences representative (or Elanco
representative at Lipid Sciences’s request) appointed by
Lipid Sciences for the second Program Year and alternating
accordingly thereafter. The chair does not have a second or
casting vote.
3.7
Minutes and Reports. The Steering Committee will be
responsible for keeping accurate minutes of its deliberations that
record all proposed decisions and all actions recommended or
taken. Within ten (10) business days of each meeting, the
chair will provide the Parties with draft minutes of such meeting
and a draft of a written accompanying report describing in
reasonable detail the status of the Design & Development
Program, a summary of the work and progress to date, any issues
requiring resolution and any proposed decisions and actions
recommended or taken to all members of the Steering
Committee. Within thirty (30) days of each meeting, the
Steering Committee will approve final versions of the meeting
minutes and the accompanying report and such minutes and
accompanying report will thereafter be recognized as duly accepted
by the Parties. All records of the Steering Committee will be
available to both Parties.
3.8
Information and Results. Except as otherwise provided,
the Parties will make available and disclose to one another all
results of the work conducted pursuant to the Design &
Development Program prior to and in preparation for the Steering
Committee meetings, by the deadline and in the form and format to
be designated by the Steering Committee.
3.9
Subcontracts. Subject to the provisions of the
Agreement, the Parties may subcontract to Affiliates and Third
Parties portions of the Design & Development Program to be
performed, provided the subcontracting Party has obtained the prior
consent of the Steering Committee; and provided, however, that such
Affiliates and Third Party subcontractors will be required to enter
into appropriate confidentiality agreements (said agreements of
which signed copies will be submitted to the Steering Committee)
unless such subcontracting would not require the transfer
11
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
of Confidential Information to the Affiliate or Third Party
subcontractor, and further provided that the Parties’ rights
under the Agreement are not adversely affected.
ARTICLE IV
4.1
Performance of Design & Development Program. The
Steering Committee will establish a program under which the Parties
will use Reasonable Commercial Efforts to collaboratively develop
Product(s) and/or New Product(s), with the initial goal of
***. The Parties will use Reasonable Commercial Efforts to
perform the design and development tasks as described in the
initial Product Development Plan subsequently attached as Exhibit
A. The Design & Development Program will be conducted by
the Parties in good scientific manner, and where necessary, in
compliance with all applicable GxP and ISO9001 design
requirements.
4.2
Product Development Plan. The Design & Development
Program will be conducted in accordance with the Product
Development Plan that describes the work to be pursued by the
Parties during each Program Year. Except for the first
Program Year, the Product Development Plan will be updated and
approved by the Steering Committee no later than sixty (60) days
prior to the start of each Program Year. The Product
Development Plan in effect at any time may not be amended except as
agreed in writing by the Steering Committee. If at any time
during the Program Year, either Party determines that a change to
the Product Development Plan would benefit the Design &
Development Program, such Party will prepare and submit to the
Steering Committee a written proposal detailing its proposed
changes to the Product Development Plan. Any budget for Lipid
Sciences’ costs under a modified Product Development Plan
that are to be reimbursed by Elanco will be approved by the
Steering Committee before Lipid Sciences commences any work on such
modified Product Development Plan.
4.3
Sharing of Testing, Marketing, Manufacturing and Regulatory
Data. Parties will provide to each other, at no charge,
access to testing, pilot manufacturing and regulatory data relevant
to Product(s) and/or New Product(s) in the Field or New Field, or
if required for regulatory purposes.
4.4
Results and Records. The Parties will make available
and disclose to one another all results of the work conducted
pursuant to the Design & Development Program, and will keep
such records as described herein; provided that each Party will
maintain such results and records of the other Party in confidence
in accordance with the confidentiality provisions in the Agreement,
and will not use such results or records except to the extent
otherwise permitted by the Agreement. The Parties will
maintain records of the results in sufficient detail and in good
scientific manner appropriate for patent purposes, and in a manner
that properly reflects all work done and results achieved in the
performance of the Design & Development Program (including all
data in the form required to be maintained under any applicable
governmental regulations). Such records will include reports,
research notes, charts, graphs, computations, analyses, recordings,
photographs, and other graphic or written data specifically
relevant to the Design & Development Program.
4.5
Availability of Employees. Each Party agrees to make
its employees and non-employee consultants reasonably available at
their respective places of employment to consult with the other
Party on issues arising during the Design & Development Program
and in connection with any request related to a Product(s) and/or
New Product(s) or the Design & Development Program from any
Regulatory Agency, including regulatory, scientific, technical and
clinical testing issues.
12
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
4.6
Visit of Facilities. Representatives of the Parties
may, upon reasonable advance notice and at times reasonably
acceptable to the other Party, visit the other Party’s
facilities where the Design & Development Program is being
conducted, and consult informally, during such visits and by
telephone, facsimile and e-mail, with the other Party’s
personnel performing work on the Design & Development
Program.
4.7 &nbs
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