Exhibit 10.6
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN
REDACTED AND
SEPARATELY FILED WITH THE COMMISSION
RESEARCH, DEVELOPMENT AND LICENSE
AGREEMENT
BETWEEN
NEOSE TECHNOLOGIES, INC.
AND
MACROGENICS, INC.
DATED April 26, 2004
Table of Contents
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Page
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1.
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DEFINITIONS.
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1
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2.
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CONDUCT OF THE PROJECT AND
DEVELOPMENT EFFORTS
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8
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3.
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OPTION AND INTELLECTUAL PROPERTY
GRANTS
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10
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4.
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OWNERSHIP OF INTELLECTUAL
PROPERTY
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13
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5.
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FEES AND MILESTONES
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16
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6.
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DILIGENCE IN COMMERCIAL
DEVELOPMENT
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19
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7.
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CONFIDENTIALITY
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20
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8.
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REPRESENTATIONS AND
WARRANTIES
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22
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9.
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INDEMNIFICATIONS AND LIMITED
LIABILITY
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24
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10.
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TERM AND TERMINATION
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25
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11.
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DISPUTE RESOLUTION
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27
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12.
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GOVERNMENT APPROVAL
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28
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13.
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MISCELLANEOUS
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29
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-i-
RESEARCH, DEVELOPMENT AND LICENSE
AGREEMENT
This
RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT
(“Agreement”) , is dated April 26, 2004, between
Neose Technologies, Inc., a Delaware corporation
(“Neose”) , and MacroGenics, Inc ., a
Delaware corporation (“MacroGenics”)
.
BACKGROUND
Neose
has developed and continues to develop proprietary technologies and
related know-how for the glycosylation, design and remodeling of
proteins, peptides and antibodies. MacroGenics has developed
and continues to develop proprietary technologies and related
know-how for developing, manufacturing and commercializing
biotechnology products, including immunotherapeutics, for cancer,
infectious diseases, and autoimmune disorders.
Neose
and MacroGenics wish to conduct collaborative research and
development activities to evaluate the effects of
glycosylation and pegylation on antibodies **** using their
respective technologies and materials, and, further, to provide
MacroGenics certain rights and options to use Neose’s
proprietary technologies.
TERMS
NOW, THEREFORE, in consideration of the premises and of the
mutual agreements and covenants contained in this Agreement, and
intending to be legally bound hereby, MacroGenics and Neose agree
as follows:
1. DEFINITIONS.
Capitalized terms not otherwise defined shall have the meaning set
forth in this Section 1 .
1.1.
“Affiliate” means, with respect to any Person,
any other Person that directly or indirectly controls, is
controlled by, or is under common control with, such Person.
Without limiting the foregoing, a Person shall be regarded as in
control of another Person if it owns, or directly or indirectly
controls, more than 50% of the voting stock or other ownership
interest of the other Person.
1.2.
“Antibody” means (i) a ****, (ii) a ****
described in clause (i) above, and/or (iii) a **** described in
clause (i) above or **** described in clause (ii) above.
1.3. “Calendar
Quarter” shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September
30 or December 31 for so long as this Agreement is in
effect.
1.4.
“Categories” means the categories of Potential
Products on which work may be conducted under the Research Plan, as
determined from time to time after taking into account the
substitutions made in accordance with this Agreement and excluding
all Deleted Categories. As of the Effective Date, the
Categories include:
1.4.1. ****
**** Material has been omitted
and filed separately with the Commission.
1.4.2. ****
1.4.3. ****
1.4.4. ****;
and
1.4.5. ****
1.5. “Category”
means any of the Categories, as determined from time to
time.
1.6. “Collaboration”
means the work conducted by either or both of the Parties during
the Research Period in furtherance of the Research Plan.
1.7. “Collaboration
Products” means any and all Potential Products that have
been modified, to any extent, in the Collaboration or by
MacroGenics by use of the Neose Technology under any license
granted hereunder, excluding Deleted Products.
1.8. “Collaboration
Technology” means the Patent Rights, Know-How and
Improvements created by either or both Parties, in the
Collaboration.
1.9. “Commercially Reasonable
Efforts” shall mean efforts and resources normally used
by a Party in similar undertakings, taking into account the
proprietary position of the product or technology involved, the
regulatory structure involved, the profitability of such
undertaking, the competitiveness of the relevant marketplace, and
other relevant factors.
1.10. “Commercial
Sale” means any sale of a Licensed Product by
MacroGenics, its Affiliates, or Sublicensees to a Person other than
their respective Affiliates or Neose.
1.11. “Confidential
Information” means any information, technical data, trade
secrets or know-how, including, but not limited to, research,
product plans, products, service plans, services, customer lists
and customers, markets, software, developments, inventions,
processes, formulas, technology, processes, designs, drawings,
engineering, marketing, distribution and sales methods and systems,
sales and profit figures, finances and other business information
which a Party treats as its confidential and/or proprietary
information.
1.12. “Control” or
“Controlled” means possession of the ability to
grant a license or sublicense as provided for herein without
violating the terms of an agreement or other arrangement with a
Third Party existing before or after the Effective Date.
1.13. “Deleted
Category” means a Category that is deleted from the
Research Plan and this Agreement as a result of the permitted
substitution of another Category or the failure to satisfy
applicable commercial diligence milestones under Section 6
.
**** Material has been omitted
and filed separately with the Commission.
-2-
1.14. “Deleted
Product” means a Collaboration Product in a Deleted
Category which Collaboration Product is not covered by a
****.
1.15. “Designated
Representative” means, in the case of Neose, its
Executive Vice President, Commercial and Clinical Development, or
such other person designated by Neose in writing from time to time
to MacroGenics, and, in the case of MacroGenics, its Chief
Operating Officer, or other such other person designated by
MacroGenics in writing from time to time to Neose.
1.16. “Designation
Period” means the period beginning on the Effective Date
and ending on the fifth anniversary of the Effective
Date.
1.17. “Effective
Date” means the date of execution of this Agreement by
both parties, as first set forth above.
1.18. “FDA” means
the United States Food and Drug Administration and any successor
agency.
1.19. “Field of
Use” means the treatment and/or prevention of a disease
or disorder in humans.
1.20. “First Licensed
Products” means each of the first two Collaboration
Products in a Licensed Category with respect to which an IND is
filed, or any Collaboration Product in a Licensed Category
thereafter substituted for a First Licensed Product by MacroGenics,
provided that there shall be no more than two First Licensed
Products at any time during the Term.
1.21. “GMPs” shall
mean current good manufacturing practices for the methods to be
used in, and the facilities and controls to be used for, the
manufacture, processing, packing and holding of biological
products, all as set forth from time to time by the FDA, including
all amendments and supplements thereto throughout the term of this
Agreement.
1.22. “HSR Act”
shall mean the Hart-Scott-Rodino Antitrust Improvements Act of
1976, as amended, and the rules and regulations promulgated
thereunder.
1.23. “Joint
Improvements” means Improvements owned jointly by the
Parties, as described in Section 4.2.3 .
1.24. “Improvements”
means any and all developments, discoveries, inventions, additions,
amendments, modifications, ideas, processes, methods, compositions,
formulae, techniques, information and data, whether or not
patentable, conceived, developed or reduced to practice, that
improve or beneficially change, or enhance the economic and
technical attributes of, any Know-How or Patent Rights or any
process, device or composition.
**** Material has been omitted
and filed separately with the Commission.
-3-
1.25. “IND” means
an application for an Investigational Exemption for a New Drug
filed with the FDA, or any comparable filing made with a regulatory
authority outside the United States.
1.26. “Know-How”
means any and all formulae, procedures, processes, methods,
designs, know-how, show-how, trade secrets, discoveries, inventions
(whether or not patentable), patent applications, licenses,
software and source code, programs, prototypes, designs,
discoveries, techniques, methods, ideas, concepts, data,
engineering and manufacturing information, electronic control
circuits, specifications, diagrams, drawings, schematics,
blueprints and parts lists and other proprietary information,
rights and works of authorship, whether or not reduced to
writing.
1.27. “License Effective
Date” shall mean, with respect to a license to be granted
hereunder with respect to a Category, the later of (i) the first
date on which MacroGenics designates the Category as a Licensed
Category under Section 3.2 or (ii) if notification is required to
be made under the HSR Act in respect of such grant, the expiration
or earlier termination of any notice and waiting period under the
HSR Act.
1.28. “Licensed
Categories” means each of the Categories designated as
such in MacroGenics’ exercise of the Option in accordance
with Section 3.2 , as determined from time to time after
taking into account the substitutions made in accordance with this
Agreement and excluding all Deleted Categories.
1.29. “Licensed
Products” means each and every First Licensed Product,
Second Licensed Product and Subsequent Licensed Product, with
respect to which a license has been granted by Neose hereunder and
remains in effect at the time of such determination.
1.30. “MacroGenics
Improvements” means any and all Collaboration Technology
(i) constituting or claiming the composition of any Potential
Product in a Licensed Category or any Collaboration Product; (ii)
constituting Improvements to MacroGenics ****; and/or (iii)
constituting Improvements to Know-How owned or Controlled by
MacroGenics on the Effective Date, except, in each case,
Collaboration Technology constituting or claiming the composition
of any Deleted Product.
1.31. “MacroGenics
Patents” means (i) all Patent Rights owned or Controlled
by MacroGenics on the Effective Date, (ii) all Patent Rights
relating to the Collaboration that are acquired by MacroGenics
after the Effective Date and owned or Controlled by MacroGenics
during the Research Term; (iii) all Patent Rights in the
MacroGenics Improvements; and (iv) MacroGenics’ interest in
and to any Patent Rights in Joint Improvements.
1.32. “MacroGenics
Technology” means MacroGenics Patents and
MacroGenics Improvements and MacroGenics undivided interest in any
and all Joint Improvements.
**** Material has been omitted
and filed separately with the Commission.
-4-
1.33. “Material”
means any and all of the materials transferred by one Party to the
other for the purposes of this Agreement, as contemplated in
Section 2.9 .
1.34. “Mutual Confidentiality
Agreement” means the Mutual Confidentiality Agreement
between the Parties dated June 20, 2003.
1.35. “Neose
Improvements” means any and all Collaboration Technology
(i) constituting Improvements to the Neose Patents owned or
Controlled by Neose on the Effective Date; (ii) constituting
Improvements to the Patent Rights acquired by Neose after the
Effective Date and owned or Controlled by Neose during the Research
Term; (iii) constituting or claiming the composition of any Deleted
Product; and/or (iv) constituting Improvements to Know-How owned or
Controlled by Neose on the Effective Date, except, in each case,
any Collaboration Technology constituting or claiming the
composition of any Potential Product in a Licensed Category or any
Collaboration Product.
1.36. “Neose
Patents” means (i) all Patent Rights owned or Controlled
by Neose on the Effective Date and all Patent Rights acquired by
Neose after the Effective Date and owned or Controlled by Neose
during the Term, which Patent Rights relate to methods and
processes for glycosylation, pegylation, design and remodeling of
proteins, peptides or Antibodies (including, without limitation,
Neose’s GlycoAdvance™, GlycoPEGylation™ and
GlycoConjugation™ technologies), and other carbohydrate
synthesis processes and resulting products; (ii) all Patent Rights
in the Neose Improvements; and (iii) Neose’s interest in and
to any Patent Rights in Joint Improvements.
1.37. “Neose
Technology” means the Neose Patents, Know-How Controlled
by Neose on the Effective Date, Know-How resulting from work
conducted by Neose under the Research Plan, Neose Improvements,
Neose’s undivided interest in any and all Joint Improvements;
and Neose’s rights under the license agreements listed on
Exhibit 1.37 .
1.38. “Net Sales”
means proceeds received from Commercial Sales of Licensed Products
by MacroGenics, its Affiliates or Sublicensees to Third Parties,
after deducting (to the extent actually incurred or reasonably
estimated and accrued in accordance with Generally Accepted
Accounting Principles in the United States and to the extent not
already deducted in the amount invoiced): (i) reasonable trade,
cash and quantity discounts or rebates (other than price discounts
granted at the time of sale), reasonable service allowances and
reasonable required agent’s commissions, if any, allowed or
paid, (ii) credits or allowances actually given or made for
rejection or return of previously sold products or for retroactive
price reductions (including Medicare, Medicaid, and/or discounts
and similar types or rebates and/or discounts), (iii) taxes, duties
or other governmental charges levied on or measured by the billing
amount (excluding income and franchise taxes), as adjusted for
rebates and refunds, and (iv) charges actually incurred for freight
and insurance directly related to the distribution of Licensed
Products (excluding amounts reimbursed by Third Party
customers). A Commercial Sale of a Licensed Product is deemed
to occur when the invoice is issued, or if no invoice is issued,
upon the earlier of shipment or transfer of title in the Licensed
Product to a Third Party.
1.39. “Option”
means the option granted to MacroGenics in Section 3.1
.
-5-
1.40. “Ownership
Rights” means any and all right, title and interest under
patent, copyright, trade secret and trademark law, or any other
intellectual property or other law, in and to any Know-How, Patent
Rights, or Improvements.
1.41. “Parties”
means MacroGenics and Neose, collectively.
1.42.“Party” means MacroGenics or Neose, as the
context requires, or each of MacroGenics and Neose,
individually.
1.43. “Patent
Rights” means any patents or patent applications,
including all corresponding foreign patents and patent
applications, all divisions, continuations, continuations-in-part,
reissues, renewals, extensions or additions to any such patents and
patent applications.
1.44. “Permit”
means any governmental or regulatory filing, submission, approval,
permit or license that is required by applicable law in any
jurisdiction worldwide for clinical trials, Commercial Sales or
other use of any of the Licensed Products.
1.45. “Person”
means an individual, corporation, partnership, trust, business
trust, association, joint stock company, joint venture, pool,
syndicate, sole proprietorship, unincorporated organization,
government, governmental agency, authority or instrumentality, or
any other form of entity not specifically listed in this
Agreement.
1.46. “Potential
Products” means each and every potential product or
product within any of the Categories, as determined from time to
time, excluding Deleted Products.
1.47. “Project
Manager” means the project managers described in
Section 2.5 .
1.48. “Reagents”
means the enzymes and sugar nucleotides required for the use of the
Neose Technology in the manufacture of Licensed
Products.
1.49. “Regulated
Market” means any jurisdiction worldwide that requires a
Permit for clinical trials, Commercial Sales or any other use of a
Licensed Product.
1.50. “Regulatory
Approval” means any marketing authorization (including
authorizations approving a Biologics License Application) required
for a Licensed Product, exclusive of any pricing or third-party
reimbursement approval.
1.51. “Required
Agreement” means the form of agreement with a Sublicensee
required under Section 3.4 .
1.52. “Research
Period” means the **** during which the Parties conduct
activities under the Research Plan, which may be extended by
amendment of this Agreement.
1.53. “Research
Plan” means the Research Plan attached as Exhibit
2.1 , as amended from time to time in accordance with this
Agreement.
**** Material has been omitted
and filed separately with the Commission.
-6-
1.54. “Royalty
Period” means, with respect to a Licensed Product in a
country, the period beginning on Commercial Sale of the Licensed
Product in the country and ending ****, provided however, that the
period shall continue thereafter for a Licensed Product sold in a
country for as long as the Licensed Product in such country
infringes a Valid Claim of a Neose Patent in such
country.
1.55. “Second Licensed
Products” means each of the third and fourth
Collaboration Products in a Licensed Category with respect to which
an IND is filed, or any Collaboration Product in a Licensed
Category substituted for a Second Licensed Product by MacroGenics,
provided that there shall be no more than two Second Licensed
Products at any time during the Term.
1.56. “Sublicense”
means a sublicense of any or all of MacroGenics’ rights under
the Neose Technology granted in accordance with Section 3
.
1.57. “Sublicensee”
means a sublicensee under a Sublicense.
1.58. “Subsequent Licensed
Products” means each of the fifth and any subsequent
Collaboration Products in a Licensed Category with respect to which
an IND is filed.
1.59. “Territory”
means the world.
1.60. “Term” means
the term of this Agreement, which shall commence on the Effective
Date and shall expire or terminate as described in Section
10 .
1.61. “Third Party”
means any Person other than MacroGenics, Neose, or their respective
Affiliates.
1.62. “Valid Patent
Claim” means a claim of an issued and unexpired patent
forming part of the Neose Patents that has not been held revoked,
unenforceable or invalid by a decision of a court or other
government agency of competent jurisdiction, or that is
unappealable or unappealed within the time allowed for appeal, or
which has not been admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise. For the purposes of
determining royalties due and payment obligations under this
Agreement, any claim being prosecuted in a pending patent
application included in the Licensed Patents shall be deemed a
Valid Patent Claim for a period ending six (6) years after the
earliest priority date to which the pending patent application is
entitled.
**** Material has been omitted
and filed separately with the Commission.
-7-
2. CONDUCT OF THE PROJECT
AND DEVELOPMENT EFFORTS
2.1. Conduct and Goal.
Commencing promptly after the Effective Date, Neose and MacroGenics
will use Commercially Reasonable Efforts to carry out their
respective obligations under the Research Plan attached as
Exhibit 2.1 . The goal of the Research Plan is to
achieve proof of concept. The Research Plan sets forth a ****
summary and timetable for the research and development activities
to be conducted by the Parties under this Agreement. The
Research Plan may be amended or modified from time to time, but
only in a writing signed by each Party’s Designated
Representative.
2.2. Selection and Substitution of
Potential Products during Research Period. The Research
Plan sets forth the Potential Products contemplated by the Parties
to be included in the Collaboration on the Effective Date.
MacroGenics shall have the right, from time to time, and on one or
more occasions during the Research Period, to substitute for any
Potential Product included in the Research Plan another Potential
Product within the same Category. Any such substitution shall
be made by an amendment of this Agreement, which shall include,
without limitation, the funding of any additional work to be
conducted by Neose beyond the scope of the original Research Plan,
as provided in Section 2.4 .
2.3. Substitution of
Categories. At any time during the Designation Period,
MacroGenics shall have the right, in up to two instances, to
request the substitution of a new category for a Category or a
Licensed Category. MacroGenics shall request any such
substitution by providing notice to Neose of the proposed new
category and the Category proposed to be deleted. Such a request by
MacroGenics shall be granted by Neose unless Neose:
2.3.1. is developing or
contemplating development of a protein in the proposed
category;
2.3.2. has granted a Third
Party a license to develop a protein or product in the proposed
category; or
2.3.3. is in discussions with
a Third Party to develop or to license rights to develop a protein
in the proposed category.
Neose shall provide notice to
MacroGenics responding to such request within thirty (30) days
after receipt of MacroGenics’ notice. Upon notice from Neose
accepting the proposed substitution or the failure by Neose to give
the required notice within thirty (30) days: (i) the proposed
category, thereafter, shall be deemed one of the Categories (as
defined in Section 1.4) or a Licensed Category , as the case may
be, and the Category proposed to be deleted, thereafter, shall be
deemed a Deleted Category. Notwithstanding any other
provision of this Section 2.3, the new Category shall not be
included in the Research Plan unless Neose shall have received
notice thereof during the Research Term prior to the commencement
of work by Neose on the Category proposed to be deleted.
**** Material has been omitted
and filed separately with the Commission.
-8-
2.4. Funding. Each Party
shall be responsible for funding its own activities under the
Research Plan. If the Research Plan is amended to increase the work
of Neose thereunder or if MacroGenics undertakes the further
development of any Licensed Product beyond the scope of the
Research Plan, MacroGenics shall be solely responsible for such
activities and the costs thereof. By mutual agreement, with
each Party acting in its sole discretion with respect thereto,
Neose may provide additional research and development services to
MacroGenics (e.g., to support the supply and scale-up of Reagents
for such further development), and MacroGenics would reimburse
Neose for its fully allocated costs associated with any such
services.
2.5. Coordination of the
Collaboration by Project Managers. Within 30 days after
the Effective Date, each of the Parties shall appoint a Project
Manager, who will be its primary contact regarding the
Collaboration. The Project Managers shall keep each other
reasonably informed of the progress under the Research Plan.
The Project Managers shall have appropriate authority and
decision-making power to carry out their respective
responsibilities hereunder. The Project Managers shall be
responsible for overseeing and directing the research under and in
accordance with the Research Plan. A Party may change its
Project Manager at any time, and from time to time, effective upon
notice to the other Party of such change.
2.6. Cooperation.
Throughout the Collaboration, the Parties shall work together in
fulfilling their roles and responsibilities under the Research
Plan, including the generation, exchange, and sharing of all
resulting data and technical reports.
2.7. Dispute Resolution.
If the Project Managers are unable to resolve, after 30 days, a
dispute regarding any issue presented to them or arising in
connection with the Collaboration, such dispute shall be referred
to the Designated Representatives for good faith resolution
pursuant to Section 11.1 .
2.8. Permits. With
respect to any clinical trials, Commercial Sales or other use of
any Licensed Product in a Regulated Market, MacroGenics shall be
responsible at its expense for obtaining all Permits required for
such activity in the applicable jurisdictions. MacroGenics
shall be responsible for the submission of all applications for
Permits for the Licensed Products, which shall be obtained and held
in the name of MacroGenics or its Affiliate(s) or Sublicensee(s),
as appropriate. Neose, at MacroGenics’ expense, shall provide
reasonable assistance and technical support to MacroGenics in
obtaining the Permits for the Licensed Products. MacroGenics
shall pay all expenses with respect to obtaining the Permits for
the Licensed Products including, without limitation, the cost of
clinical trials and preparation and prosecution of permit
applications. MacroGenics shall be solely responsible for
renewing any Permits at its expense.
2.9. Transfer of Materials.
From time to time during the Term, each Party may transfer
to the other Party certain materials for use in performing its
obligations under the Research Plan. It is contemplated that
Neose will provide to MacroGenics one or more of the following
materials: ****. It is also contemplated that MacroGenics
will provide to Neose one
**** Material has been omitted
and filed separately with the Commission.
-9-
or more of the following
materials: ****. All Materials shall be transferred and
received by the Parties subject to following terms and
conditions.
2.9.1. The Party receiving
Material (“Recipient”) agrees to defend, indemnify, and
hold harmless the Party providing such Material
(“Provider”) from any Third Party loss, claim, damage,
or liability of any kind whatsoever, which may arise from
Recipient’s use, storage, or disposal of the Material, and
Recipient assumes liability for claims or damages which may arise
from its use, storage or disposal of such Material, except to the
extent that such liability may arise from gross negligence or
malfeasance on the part of the Provider.
2.9.2. The Recipient shall use
the Material received hereunder solely for the purpose of
performing its obligations under this Agreement and subject to its
terms. The Recipient shall not transfer any of the Material
received hereunder, or any progeny, derivatives, or modifications
thereof, to any Person other than its employees who require such
access for the purpose of performing its obligations under this
Agreement, except with the prior written consent of the
Provider. In no event shall the Recipient use any Material
received hereunder in human beings (including for diagnostic
purposes).
2.9.3. Any research involving
the Material received hereunder (including but not limited to
research involving the use of animals and recombinant DNA) shall be
conducted in accordance with all federal, state, local, and other
laws, regulations and ordinances governing such research including
applicable NIH guidelines.
2.9.4. Upon expiration or
termination of this Agreement, each Recipient will immediately
discontinue its use of the Material received hereunder and will,
upon direction of the Provider, return or destroy such
Material.
2.10. Additional Development
Activities. Except as set forth in the Research Plan,
Neose shall not have any obligation to perform any further
research, development, scale-up services, technology transfer,
technical support, improvements, modifications, or any other
activities under this Agreement. If MacroGenics undertakes
the development of any Collaboration Product after the expiration
or termination of the Research Plan, MacroGenics will assume the
full responsibility and costs thereof. MacroGenics
acknowledges that it does not have, and shall not acquire
hereunder, any rights under the Neose Technology to develop any
Collaboration Product other than a Collaboration Product in a
Licensed Category.
2.11. Additional ****.****.
Except for the licenses to be granted by Neose under
Section 3 , **** that may be **** in connection with the
development and/or commercialization of Licensed
Products.
3. OPTION AND INTELLECTUAL PROPERTY
GRANTS
3.1. Option. Neose
hereby grants to MacroGenics a sole and exclusive right and option
to obtain an exclusive license under the Neose Technology to
develop and commercialize Collaboration Products in each of two
Categories. The Option may be exercised
**** Material has been omitted
and filed separately with the Commission.
-10-
as set forth in Section
3.2. Neose covenants and agrees that during the Designation
Period: (i) Neose will not grant any rights or licenses to any
Third Party with respect to any Potential Product in any Category,
and (ii) except for the Collaboration, Neose will not perform any
work or research with any Potential Product in any
Category.
3.2. Option Exercise. On
one or two occasions during the Designation Period, by notice from
MacroGenics to Neose, MacroGenics shall have the right to designate
up to two Categories as Licensed Categories, and, in each instance,
upon the License Effective Date, Neose shall grant a license with
respect to the Licensed Category as provided in Section 3.3
.
3.3. Exclusive License With Respect
to Two Categories. Subject to the terms and conditions
of this Agreement, Neose hereby agrees to grant to MacroGenics,
with respect to each of two Licensed Categories, as of the
respective License Effective Date, an exclusive, royalty-bearing
license (or sublicense) under the Neose Technology ****, (i) to
make, have made, use, sell, offer to sell and import Potential
Products in the Licensed Category in the Field of Use in the
Territory, and (ii) to make, have made and use Reagents in the
Territory solely for the purpose of making and having made
Potential Products in the Licensed Category. The licenses
granted pursuant to this Section 3.3 shall include a right
to grant Sublicenses in accordance with Section 3.4
.
3.4. Sublicense Rights.
Prior to the earlier of entering into a Sublicense or providing a
proposed Sublicensee with Confidential Information of Neose,
MacroGenics shall give notice to Neose identifying, and seeking
Neose’s approval of, the proposed Sublicensee. Neose
shall have the right to deny such approval, by notice to
MacroGenics within twenty (20) days after receipt of
MacroGenics’ notice, if Neose demonstrates that the proposed
Sublicensee: (i)****. If Neose approves a proposed
Sublicensee or does not respond to MacroGenics’ notice
regarding a proposed Sublicensee within the twenty (20)-day period,
MacroGenics shall be entitled: (x) to provide Confidential
Information of Neose to the proposed Sublicensee after delivering
to Neose an original non-disclosure and non-use agreement
substantially in the form attached hereto as Exhibit 3.4
which has been duly executed by the proposed Sublicensee; and/or
(y) to enter into a Sublicense with the proposed Sublicensee, which
Sublicense shall contain provisions requiring the Sublicensee to
comply with the provisions of this Agreement relating to
Confidential Information and the ownership of intellectual property
(including, without limitation, the provisions of Section 4
of this Agreement applicable to MacroGenics), which provisions
shall be provided to Neose by MacroGenics at least five (5)
business days before the execution of the Sublicense. If
Neose duly denies approval of a proposed Sublicensee, MacroGenics
shall not provide the proposed Sublicensee any Confidential
Information of Neose and shall not enter into a Sublicense with the
proposed Sublicensee.
3.5. Liability.
MacroGenics shall remain primarily liable to Neose for the
performance by each Affiliate and Sublicensee in accordance with
the terms and conditions of this Agreement that are applicable to
an Affiliate or Sublicensee, as the case may be.
3.6. Reservation of Rights.
Neose hereby reserves to itself all right, title and
interest in and to the Neose Technology not expressly granted in
any license that may be granted
**** Material has been omitted
and filed separately with the Commission.
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pursuant to Section 3.3
. Without limiting the foregoing, in no event shall this
Agreement be construed to prohibit Neose from engaging in any of
the following activities: (a) practicing the processes, methods and
Know-How of the Neose Technology outside of the Categories at any
time, or outside of the Licensed Categories at any time following
the Designation Period, in each case, within the Field of Use or
otherwise and including, without limitation, with potential
products or products that may be considered competitive with any of
the Licensed Products; (b) developing, making, using or selling
proteins or Reagents, whether in conjunction with the Neose
Technology or otherwise, for any use except in connection with the
development or commercialization of Potential Products in any
Category during the Designation Period, or in any Licensed Category
at any time following the Designation Period; or (c) entering into
and performing agreements with Third Parties regarding any of the
foregoing including, without limitation, research agreements,
development agreements and licensing agreements.
3.7. MacroGenics Technology.
Subject to the terms and conditions of this Agreement, and
solely to the extent necessary to enable Neose to carry out its
obligations under the Research Plan, MacroGenics hereby grants to
Neose, for the Research Period, a non-exclusive, royalty-free,
license under the MacroGenics Technology to use such MacroGenics
Technology for the sole purpose of carrying out its obligations
under the Research Plan. MacroGenics shall retain at all
times all of its rights, title and interest to the MacroGenics
Technology.
3.8. No Other Right or
Licenses. Except for the rights and licenses expressly
granted in this Agreement or granted upon the exercise of the
Option, nothing in this Agreement shall be deemed to grant to any
Party or Person any other rights or licenses, including, without
limitation, any implied licenses.
3.9. Restriction on Exercise of
License Rights. Under the licenses granted to
MacroGenics pursuant to Section 3.3 , MacroGenics shall not,
and shall not grant to any Third Party the right to, make, have
made, use, sell, offer to sell, or import any Potential Product in
any Licensed Category that would result in there being more than
two First Licensed Products and two Second Licensed Products at any
time during the Term, unless and until the Parties shall have
negotiated the fees, milestones, royalties, and any other special
terms applicable to the exercise of any such rights with respect to
Subsequent Licensed Products, with each Party acting in its sole
discretion with respect to such negotiations.
3.10. Compliance with
Sublicenses. From and after the License Effective Date
of a license granted in accordance with Section 3.3 , except
for the payment provisions, MacroGenics shall comply with the terms
and conditions of each license under which Neose is the licensee,
which license is included in the Neose Technology licensed to
MacroGenics with respect to Potential Products in the Licensed
Category in the Field of Use. ****
3.11. Technology Transfer.
Promptly following the License Effective Date of a license
granted in accordance with Section 3.3 , Neose shall use
Commercially Reasonable Efforts to transfer to MacroGenics the
Know-How owned or Controlled by Neose that is useful
**** Material has been omitted
and filed separately with the Commission.
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in connection with the exercise
by MacroGenics of its rights under such license with respect to
Potential Products in the Licensed Category in the Field of
Use.
4. OWNERSHIP OF INTELLECTUAL
PROPERTY
4.1. Intellectual Property
Rights. All Ownership Rights in and to the Neose
Technology shall remain at all times with Neose. All
Ownership Rights in and to the MacroGenics Technology shall remain
at all times with MacroGenics, subject to the Parties’
obligations to assign certain Ownership Rights to the other Party
under Sections 4.3 and 4.4 .
4.2. Improvements
4.2.1. Neose
Improvements. Any
and all Neose Improvements shall be owned solely by Neose and shall
be deemed to be part of the Neose Technology for all purposes,
including, without limitation, the licenses to be granted under
Section 3.3 . Except as provided in Section 4.4
, any and all Collaboration Technology constituting Improvements
made, conceived, or reduced to practice solely by Neose shall be
owned by Neose.
4.2.2. MacroGenics
Improvements. Any and all Collaboration Technology
constituting MacroGenics Improvements shall be owned solely by
MacroGenics for all purposes, including, without limitation, the
license granted under Section 3.7 . Except as set
forth in Section 4.3 , any and all Improvements made,
conceived, or reduced to practice, solely by MacroGenics shall be
owned by MacroGenics.
4.2.3. Joint Improvements.
Except as otherwise provided in this Section 4.2.1 or
4.2.2 , each of Neose and MacroGenics shall own a one-half
undivided interest in any Collaboration Technology constituting
Improvements made, conceived, or reduced to practice jointly by
Neose and MacroGenics, whether patentable or not, provided,
however, that a Party shall lose its one-half undivided interest in
any Patent Rights included in Joint Improvement with respect to
which it does not fund patent prosecution and maintenance costs, as
provided in Section 4.5 .
4.3. Assignment by MacroGenics.
To the extent that MacroGenics may obtain or retain any
Ownership Rights in any Neose Improvements, MacroGenics hereby
irrevocably assigns and transfers, and agrees to assign and
transfer, to Neose any and all such Ownership Rights, in perpetuity
or for the longest period otherwise permitted by law, without the
necessity of further consideration, and Neose shall be entitled to
receive and hold in its own name all such Ownership Rights.
With respect to any Ownership Rights that MacroGenics is required
to assign and transfer to Neose under this Section 4.3
, at the request of Neose and at Neose’s expense, either
before or after termination of the Term, MacroGenics shall assist
Neose in acquiring and maintaining patent, copyright, trade secret
and trademark protection upon, and confirming Neose’s title
in and to, any such respective Ownership Rights, and MacroGenics
shall provide Neose appropriate documentation evidencing Ownership
Rights to which Neose is entitled. MacroGenics’
assistance shall include, but shall not be limited to, signing all
applications, and any other documents and instruments for patent,
copyright and any other proprietary rights, providing executed
license documents, cooperating in legal proceedings, and taking any
other actions considered necessary or desirable by Neose. For
the purpose of
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facilitating the above
assignments, MacroGenics agrees that any and all employees and
contractors employed or engaged by MacroGenics and providing any
service in connection with the Collaboration, prior to providing
such service, shall have agreed in writing to covenants consistent
with MacroGenics’ covenants set forth in this Section
4.3 .
4.4. Assignment by Neose.
To the extent that Neose may obtain or retain any Ownership
Rights in any MacroGenics Improvements, Neose hereby irrevocably
assigns and transfers to MacroGenics any and all such Ownership
Rights, in perpetuity or for the longest period otherwise permitted
by law, without the necessity of further consideration, and
MacroGenics shall be entitled to receive and hold in its own name
all such Ownership Rights. With respect to any Ownership
Rights that Neose may assign and transfer to MacroGenics under this
Section 4.4 , at the request of MacroGenics, and at
MacroGenics’ expense, either before or after termination of
this Agreement, Neose shall assist MacroGenics in acquiring and
maintaining patent, copyright, trade secret and trademark
protection upon, and confirming MacroGenics’ title in and to,
any such respective Ownership Rights. Neose’s
assistance shall include, but shall not be limited to, signing all
applications, and any other documents and instruments for patent,
copyright and any other proprietary rights, cooperating in legal
proceedings, and taking any other actions considered necessary or
desirable by MacroGenics. For the purpose of facilitating the
above assignments, Neose agrees that any and all employees and
contractors employed or engaged by Neose and providing any service
in connection with the Collaboration, prior to providing such
service, shall have agreed in writing to covenants consistent with
Neose’s covenants set forth in this Section 4.4
.
4.5. Prosecution and Maintenance of
Patent Rights in Collaboration Technology. Each Party
shall have the right, in its sole discretion and at its sole
expense, to prepare, file, prosecute and maintain all Patent Rights
covering Collaboration Technology that the Party solely owns, as
determined in accordance with Section 4 . With respect
to Joint Improvements, the Parties shall meet to determine whether
patent protection is appropriate and, if so, in which countries, if
any, patent applications claiming such joint inventions and
discoveries should be filed. The Parties shall jointly file,
prosecute, and maintain, such patent applications, with each Party
funding one-half of the costs thereof. Either Party may at
any time, in its sole discretion, discontinue funding the
preparation, prosecution or maintenance of any Patent Rights
covering Joint Improvements, in which case the Party discontinuing
such support shall provide notice thereof to the other Party.
The Parties shall retain undivided equal interests in and to all
Patent Rights covering Joint Improvements for as long as they are
sharing the costs of prosecuting and maintaining such Patent
Rights. If a Party discontinues funding the preparation,
prosecution or maintenance of any Patent Rights covering Joint
Improvements, the other Party shall, thereafter, have sole rights
in and to such Patent Rights.
4.6. Use and Sublicensing of Joint
Improvements. Subject to the exclusive rights granted to
MacroGenics under this Agreement, the exclusive Ownership Rights of
the Parties under this Section 4 , and the funding
obligations of the Parties under Section 4.5 , each Party
shall be entitled to use its rights to Joint Improvements
(including joint Patent Rights and joint Know-How) to develop, use,
make, have made, import, offer to sell and sell products. Except
for a Sublicense granted by MacroGenics in accordance with
Section 3 , if either Party wishes to sublicense any of its
rights in and to Joint Improvements, it shall provide notice
thereof to the other Party requesting its consent to grant the
proposed sublicense, which consent shall not
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be unreasonably withheld.
The notice shall identify the proposed sublicensee, field of use,
territory and other relevant factors. Except for a Sublicense
granted by MacroGenics in accordance with Section 3 , if a
proposed sublicense would permit a Third Party to develop a
Potential Product, then a Party shall be entitled to withhold
consent and the sublicense shall not be granted. If a Party
consents to the grant of any such proposed sublicense, the
sublicensor Party shall pay the other Party a royalty of 1.5% of
(i) net sales under the sublicense and (ii) any other revenues
received by the sublicensor Party from the
sublicensee.
4.7. Enforcement of Ownership
Rights
4.7.1. Reports of Infringement.
MacroGenics shall promptly report in writing to Neose during
the Term any infringement or misappropriation or suspected
infringement or misappropriation of any Neose Technology of which
MacroGenics becomes aware and shall provide Neose with its full
cooperation in the protection and enforcement of the Neose
Technology and all available evidence supporting said infringement,
misappropriation, suspected infringement or unauthorized use or
misappropriation. Neose shall reimburse MacroGenics for its
reasonable, documented costs of such cooperation, unless such
infringement or misappropriation is caused by an Affiliate or
Sublicensee of MacroGenics.
4.7.2. Right to Institute Suit.
Except as set forth in Sections 4.8 and 4.9 ,
Neose shall have the first right to initiate an infringement or
other appropriate suit against any Third Party who at any time has
infringed or is suspected of infringing or misappropriating, the
Neose Technology with respect to a Potential Product in a Licensed
Category in the Field of Use. MacroGenics shall have the
right to participate in and be represented by counsel in any such
suit at MacroGenics’ expense, and Neose shall control any
such suit initiated by Neose. Neose shall not enter into any
settlement, consent judgment or other voluntary final disposition
of such suit that would adversely affect MacroGenics’ rights
under this Agreement or that would adversely affect the scope,
validity or enforceab