EXHIBIT 4.10
RESEARCH COLLABORATION AND SERVICE AGREEMENT/1/
(EXECUTION COPY)
THIS COLLABORATION AGREEMENT (together with the attached Exhibits, the
"Agreement") is made as of March 29, 1999 (the "Effective Date") by and among
Genetics Institute, Inc., a Delaware corporation with a business address at ▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("GI"), and Cambridge
Antibody Technology Limited ("CAT"), with a business address at ▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇, ▇▇.
1. Background.
WHEREAS, CAT is an entity in the field of rapid human antibody discovery,
engineering and other related activities,
WHEREAS, GI is an entity working in the field of drug discovery, and
WHEREAS, CAT and GI wish to enter into this research collaboration and contract
research arrangement on the terms and conditions set forth in this Agreement.
2. Definitions. As used in this Agreement, the following terms shall have the
meanings set forth below.
2.0 "Ab Engineering Services" means the antibody engineering services
contemplated by Article 21 hereof.
2.1 "Accepted Antigen" means (a) the antigens set forth in Exhibit A
hereof and (b) any Additional Target Antigen accepted by the RMC
pursuant to Section 3.3(b).
2.2 "Additional Target Antigens" means those additional target antigens
offered by GI or CAT to the RMC for consideration for inclusion in the
Product Collaboration pursuant to Section 3.3 hereof.
2.3 "Affiliate" means any corporation, company, partnership, joint venture
and/or firm which controls, is controlled by or is under common
control with a Party. For purposes of this Section 2.3, "control"
means (a) in the case of corporate entities, direct or indirect
ownership of at least fifty percent (50%) of the stock or shares
entitled to vote for the election of directors; and (b) in the case of
non-corporate entities, direct or indirect ownership of at least fifty
percent (50%) of the equity
_______________________
/1/ [***] indicates that text has been deleted, which is subject to a
confidential treatment request. This text has been filed with the SEC on a
supplemental basis.
interest with the power to direct the management and policies of such
noncorporate entities.
2.4 "Antibody" or "Ab" means a molecule or a gene encoding such a
molecule, developed or identified in performance of the Product
Collaboration or Contract Research Program, as applicable, and
comprising or containing one or more immunoglobulin variable domains
or parts of such domains or any fragments, variants, modifications or
derivatives thereof.
2.5 "Available Abs" means any Collaborative Ab selected by the RMC for
inclusion in the Selection Pool.
2.6 "CAT" shall mean Cambridge Antibody Technology Limited.
2.7 "CAT Ab" means any Available Ab selected by CAT pursuant to Article 9
hereof.
2.8 "CAT Background IP" shall mean all patents and patent applications of
CAT (including those licensed to CAT by a third party which CAT has
the right to sublicense hereunder), which relate to an Antibody,
Accepted Antigen or a Collaborative Ab, and are reasonably necessary
to research, develop, use, register, import, manufacture, have
manufactured, formulate, fill and finish, distribute and/or sell
Licensed Product(s).
2.9 "CAT Library Technology" means the collection of bacteriophages each
of which displays an Antibody or a collection of host cells containing
such collection of bacteriophages possessed by CAT as of the date GI
exercises its Library Option pursuant to Section 20.1.
2.10 "CAT Background Technology" shall mean any proprietary information or
materials, patentable or otherwise, of CAT (including that licensed to
CAT by a third party which CAT has the right to sublicense hereunder,
excluding those Independent Developments described in Section 3.1(c)),
which relate to an Antibody, Accepted Antigen, or Collaborative Ab,
and are necessary to research, develop, use, register, import,
manufacture, formulate, fill and finish, distribute and/or sell
Licensed Therapeutic Product(s) and Licensed Diagnostic Product(s),
including, without limitation, scientific discoveries and results,
developments, preclinical data, clinical data, regulatory filings and
records related thereto. The Parties acknowledge that it is not their
intention that CAT Background Technology include general proprietary
research tools or technologies used to make discoveries or
formulations, process development and/or manufacturing technologies
that are not specifically and solely related to the Collaborative Ab.
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2.11 "Collaborative Abs" means an Antibody selected for engineering by
the RMC pursuant to Section 3.5(a) hereof.
2.12 "Confidential Information" includes, without limitation, any
scientific, technical, trade or business information disclosed by
one Party to the other Party which is (a) disclosed in writing or
other tangible form and labeled "CONFIDENTIAL" at the time of
disclosure or (b) disclosed verbally.
"Confidential Information" does not include information which (a)
was known to the receiving Party at the time it was disclosed,
other than by previous disclosure by the disclosing Party, as
evidenced by written records at the time of disclosure; (b) is at
the time of disclosure or later becomes publicly known under
circumstances involving no breach of this Agreement; (c) is
lawfully and in good faith made available to the receiving Party
by a third party who did not derive it from the disclosing Party
and who imposes no obligation of confidence on the receiving
Party; or (d) is developed by the receiving Party independent of
any disclosure by the disclosing Party, as evidenced by written
records or (e) is required by law to be disclosed, provided prior
to any such disclosure, the disclosing party shall give the other
party a reasonable opportunity to contest the requested
disclosure.
2.13 "Contract Research Program" shall mean the Contract Research
Program as set forth in Articles 15, 16, 17 and 18, 19 and 21
hereof.
2.14 "Contract IP" shall have the meaning given such term in Section
15.3 hereof.
2.15 "Date of First Commercial Sale" means with respect to any
Licensed Product(s) or Research Product(s), the date of the first
sale for end use or consumption of such Licensed Product(s) or
Research Product(s) in a country.
2.16 "Diagnostic Licensed Product(s)" shall mean any product in
whatever form (a) incorporating substantially all of or at least
one variable region of an Available Ab and (b) used for a
diagnostic purpose.
2.17 "Engineering Criteria" means the criteria for the engineering of
antibodies, established and agreed upon by the Parties at such
time as engineering is undertaken pursuant to Section 3.5.
2.18 "Exclusive Licensee" shall have the meaning given such terms in
Section 10.1 hereof.
2.19 "First Available Ab" means the first Available Ab introduced into
the Selection Pool.
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2.20 "GI" shall mean Genetics Institute, Inc., American Home Products
Corporation, and any wholly owned subsidiaries thereof.
2.21 "GI Ab" means Available Abs selected by GI pursuant to Article 9.
2.22 "GI Background IP" shall mean all patents and patent applications
of GI (including those licensed to GI by a third party which GI
has the right to sublicense hereunder and excluding (a) those
previously exclusively licensed by GI to a thirty party and (b)
those Independent Developments described in Section 3.1(c)),
which relate to a Accepted Antigen, Antibody, or a Collaborative
Ab and are necessary to research, develop, use, register, import,
manufacture, have manufactured, formulate, fill and finish,
distribute and/or sell Licensed Product(s).
2.23 "GI Background Technology" shall mean any proprietary information
or materials, patentable or otherwise, of GI (including that
licensed to GI by a third party which GI has the right to
sublicense hereunder and excluding information or materials (a)
previously exclusively licensed by GI to a third party and (b)
those Independent Developments described in Section 3.1(c)),
which relate to a Accepted Antigen, Antibody, or Collaborative Ab
and is necessary to research, develop, use, register, import,
manufacture, formulate, fill and finish, distribute and/or sell
Licensed Therapeutic Product(s) and Licensed Diagnostic
Product(s), including, without limitation, scientific discoveries
and results, developments, preclinical data, clinical data,
regulatory filings and records related thereto. The Parties
acknowledge that it is not their intention that GI Background
Technology include general proprietary research tools or
technologies used to make discoveries or formulations, process
development and/or manufacturing technologies that are not
specifically and solely related to the Collaborative Ab.
2.24 "ICC Data" shall mean all immunocytochemistry data generated
under the Contract Research Program.
2.25 "ICC Tissue Panel" means the tissue identified in Exhibit C, as
may be amended from time to time by the parties.
2.26 "Improvements" means any improvements, modifications and
adaptations solely (whether patentable or otherwise) to either
CAT or GI Background IP, arising from the Product Collaboration.
2.27 "Independent Development(s)" shall mean any information, or
Materials, know-how or inventions of GI (a) arising outside the
Product Collaboration and (b) discovered without the use of any
Product Collaboration IP, CAT Background IP or CAT Background
Technology.
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2.28 "Intellectual Property" shall mean, collectively, Product
Collaboration IP and Contract Research Program IP.
2.29 "Introduction Date" means the date the RMC, pursuant to Section
3.6 hereof, introduces a Collaborative Ab to the Selection Pool.
2.30 "Licensed Product(s)" shall mean collectively, Therapeutic
Licensed Product(s) and Diagnostic Licensed Product(s), in
whatever form (including without limitation, bulk active,
formulated or unformulated bulk, final or packaged final labeled
forms).
2.31 "Major Market" shall mean United States, Europe or France,
Germany, Italy, Japan, or the United Kingdom.
2.32 "Minimum Performance Requirements" shall have the meaning given
such term in Section 16.3 hereof.
2.33 "Net Sales" means the aggregate United States dollar equivalent
of gross revenues derived by or payable to a selling Party, its
Affiliates and sublicensees from or on account of the sale or
distribution of Licensed Product(s) or Research Product(s)
("Products") to third parties, less (a) reasonable credits or
allowances, if any, actually granted on account of price
adjustments, recalls, rejection or return of items previously
sold, (b) excises, sales taxes, value added taxes, consumption
taxes, duties or other taxes imposed upon and paid with respect
to such sales (excluding income or franchise taxes of any kind)
and (c) separately itemized insurance and transportation costs
incurred in shipping Products to such third parties. No deduction
shall be made for any item of cost incurred by a selling party,
its Affiliates or sublicensees in preparing, manufacturing,
shipping or selling Products except as permitted pursuant to
clauses (a), (b) and (c) of the foregoing sentence. Net Sales
shall not include any transfer between a selling Party and any of
its Affiliates or sublicensees for resale, but shall include the
resale price to a third party payable to such Affiliates or
sublicensees.
If a selling Party or an Affiliate or sublicensee sells Products
to a distributor which is not an Affiliate, the gross revenues
derived by or payable to that selling Party or the applicable
Affiliate or sublicensee on account of such sale shall be the
gross revenues received by the selling Party and/or the
applicable Affiliate or sublicensee from the sale of Products to
the distributor. If the distributor is an Affiliate, then gross
revenues derived by or payable to that selling Party or the
applicable Affiliate or sublicensee shall be those received from
the sale to the first third party which is not an Affiliate.
In addition, in order to ensure the full royalty payments
contemplated under this Agreement, in the event any Product is
sold to any corporation, firm or association
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with which GI or CAT, as the case may be, has an agreement,
understanding or other arrangement with respect to other forms of
consideration (for example, an option to purchase stock or actual
stock ownership; an arrangement involving division of profits or
special rebates or allowances) royalties shall be calculated for
sales of such Products based upon the greater of (a) the price at
which the purchaser of such Products resells such Products to the
end user or (b) the fair market value of such Products or (c) the
price of such Products paid by the purchaser.
Unless otherwise specified herein, in the event that a selling
Party or any of its Affiliates or sublicensees shall make any
transfer of Products to third parties for other than (a) in a
bona fide arms-length transaction exclusively for monetary value
or (b) upon use of Licensed Product for purposes which do not
result in a disposal of such Licensed Product in consideration of
sales revenue customary in the country of use, such transfer or
other disposition, such shall be considered a sale hereunder for
accounting and royalty purposes. Net Sales for any such transfers
shall be determined on a country-by-country basis and shall be
the average price of "arms length" sales by that selling Party,
its Affiliates or sublicensees in such country during the royalty
reporting period in which such transfer occurs or, if no such
"arms length" sales occurred in such country during such period,
during the last period in which such "arms length" sales
occurred. If no "arms length" sales have occurred in a particular
country, Net Sales for any such transfer in such country shall be
the average price of "arms length" sales in all countries by that
selling Party.
In the event a Licensed Product is sold in combination with other
active components ("Combination Product"), Net Sales for purposes
of royalty payments shall be calculated by multiplying the Net
Sales of the Combination Product by the fraction A/(A/B), where
"A" is the gross selling price of the Product sold separately
(i.e. without the other active components) and "B" is the gross
selling price of the other pharmaceutically active components. In
the event that no separate sales are made, Net Sales for royalty
payments shall be negotiated in good faith.
Notwithstanding the foregoing, no transfer of Products for
testing, pre-clinical, clinical or developmental purposes or as
samples shall be considered a sale hereunder for accounting and
royalty purposes.
2.34 "Non-Ab Licensed Product(s)" means any human therapeutic or
diagnostic product developed or identified in performance of the
Product Collaboration, excluding Licensed Product(s).
2.35 "Notice of Intent" shall have the meaning given such term in
Section 9.3(a) hereof.
2.36 "Offering Party" shall have the meaning given such term in
Section 9.1 hereof.
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2.37 "Oncology Rights" means the use of any Product Collaboration IP
and/or Product Collaboration Technology in the field of oncology.
2.38 "Option Acceptance" means the written notice submitted by the
Recipient Party to the Picking Party pursuant to Section 9.2
hereof.
2.39 "Option Payment" shall have the meaning given such terms in
Section 9.2.
2.40 "Option Payment Date" means the date on which a Party pays an
Option Payment pursuant to Section 9.2 hereof.
2.41 "Option Price" means the irrevocable cash amount set forth in a
Party's Firm Offer (as defined in Section 9.1).
2.42 "Party" or "Parties" means GI and/or CAT.
2.43 "Purchasing Party" shall have the meaning given such term in
Section 9.3 hereof.
2.44 "Product Collaboration" means the collaborative activities
between GI and CAT described in Articles 3-14 hereof.
2.45 "Product Collaboration IP" shall mean the intellectual property
described in Section 4(a) hereof.
2.46 "Product Collaboration Plan" means the three (3) year research
plan developed by the RMC pursuant to Section 3.2 hereof, which
sets forth the Product Collaboration, as amended from time to
time by the RMC.
2.47 "Product Collaboration Term" means the term of the Product
Collaboration as set forth in Article 5 hereof.
2.48 "Research Abs" shall mean all antibodies generated under the
Contract Research Program.
2.49 "Research Antigens" shall mean any antigen offered by GI to the
Contract Research Program.
2.50 "Research Product(s)" means products for human therapeutic or
diagnostic use, incorporating substantially all of at least one
region of any Antibody arising from the Contract Research
Program.
2.51 "Recipient Party" shall have the meaning given such term in
Section 9.1 hereof.
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2.52 "RMC" shall mean the Research Management Committee as defined in
Section 3.2 hereof.
2.53 "Selection Period" shall have the meaning given such term in
Section 9.3.
2.54 "Selection Pool" means the pool of Available Abs from which the
Parties select such Available Abs, pursuant to Article 9.
2.55 "Hardware/Software" means the items set forth in Exhibit D
hereof.
2.56 "Therapeutic Licensed Product(s)" shall mean products, for any
human therapeutic use, incorporating substantially all or at
least one variable region of an Available Ab.
2.57 "Valid Patent Rights" shall mean a claim of an issued or granted
patent which shall not have expired or been withdrawn, canceled
or disclaimed, nor held invalid or unenforceable, in an
unappealed or unappealable decision, by a court or other
governmental body of competent jurisdiction or in an interference
proceeding.
2.58 "Contract Background IP" means any proprietary information or
materials, patentable or otherwise of CAT, including ProAb and
any other general research tools or technologies used to make
discoveries or formulations, process development or manufacturing
technologies which (a) relate to a Research Ab and (b) are
necessary to research, develop, use, register, import,
manufacture, formulate, fill and finish, distribute and/or sell
Research Product(s).
2.59 "CAT Antibody Patents" means [***].
2.60 "Full Length Sequence" means an amino acid sequence that is
anticipated by GI to be encoded by the open reading frame of a
full-length cDNA.
2.61 "GI/MRC/Dyax Sublicensee Royalties" means the royalties on Net
Sales of Licensed Products and Research Products relating to the
MRC License and the Dyax License and payable by GI for the
benefit of MRC and Dyax, as set forth in Exhibit B.
3. Product Collaboration.
3.1 Goal.
(1) Except as otherwise expressly provided by this Agreement,
the Parties shall each conduct the Product Collaboration
with the goal of rapidly discovering Collaborative Abs for
evaluation, selection and development by GI and/or CAT, and
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(2) During the Product Collaboration Term and subject to any rights
granted pursuant to Article 10 hereof, GI and CAT shall not knowingly
develop, for itself or with a third party, any antibody product
directed to an Accepted Antigen.
(3) Notwithstanding anything herein to the contrary, the parties hereby
agree that any antibody acquired by or licensed to GI or CAT in
connection with (a) an acquisition by GI or CAT of all or a portion of
the assets of another entity or (b) a merger, consolidation or sale of
all or substantially all of GI's or CAT's assets, shall not be subject
to restriction set forth in subparagraph (b) of this Section 3.1 and
shall be deemed an Independent Development. CAT and GI shall have no
rights in and to any Independent Development.
3.2 Product Collaboration Activities; RMC.
(1) Within thirty (30) days following the Effective Date, GI and CAT shall
form a Research Management Committee ("RMC") to
(1) develop a Product Collaboration Plan and advise the Parties on
the direction of the Product Collaboration,
(2) coordinate the Parties' activities under the Product
Collaboration, and
(3) facilitate the exchange of ideas and information by GI and CAT
under the Product Collaboration. The RMC shall consist of four
(4) members, two (2) of whom shall be designated by GI and two
(2) of whom shall be designated by CAT. Each member shall have
appropriate technical credentials, experience and knowledge, and
ongoing familiarity with the Product Collaboration. GI and CAT
may assign its members to the RMC as it deems appropriate, and
designated substitutes may represent RMC members at regularly
scheduled meetings at the discretion of the substituting Party.
The RMC will meet at least once per calendar quarter, alternating
between GI and CAT locations, to review their progress under the
Product Collaboration and other activities under this Agreement.
Actions by and decisions of the RMC shall require the affirmative
vote of all RMC members, provided however, in the event that the
RMC cannot or does not, after good faith efforts, reach agreement
on an issue, the resolution and/or course of action shall be
determined by senior executives from GI and CAT. In addition, GI
and CAT shall each designate an overall project manager to
coordinate preparation of short written reports summarizing each
Party's research efforts, to be
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provided to each of the RMC members in advance of each quarterly
RMC meeting. Meetings shall be minuted and copies of the minutes
shall be circulated to all members of the RMC.
(2) In conducting its activities under the Product Collaboration, each
party shall at their own expense allocate at least [***] full time
equivalent scientists, together with such technical staff, equipment
and supplies as are reasonably necessary to support such scientists.
3.3 Phase I: Validation of Accepted Antigens.
(1) Pursuant to the Product Collaboration Plan, GI shall supply to the RMC
the Accepted Antigens set forth in Exhibit A and all material and GI
Background IP related to such Accepted Antigens and necessary for and
the sole purpose of the performance of the RMC's obligations under
this Article 3. GI and CAT shall work diligently to validate such
Accepted Antigens as therapeutic targets and shall promptly report all
results of such work to the RMC. Such validation may involve use of
the antibodies generated pursuant to Section 3.4
(2) Additionally, at any time during the Product Collaboration, CAT or GI
may propose Additional Target Antigens to the RMC for acceptance. If
the RMC accepts such Additional Target Antigens for inclusion into the
Product Collaboration, the proposing Party shall supply to the RMC
such related material and Background IP (GI or CAT Background IP, as
appropriate) necessary for the performance of the RMC's obligations
under this Article 3.
3.4 Phase II: Generation of Antibodies.
(1) With respect to each Accepted Antigen identified pursuant to Section
3.3, CAT, utilizing its process, shall
(1) make diligent efforts, using any available CAT technology to
generate Antibodies specific for each Accepted Antigen and
(2) deliver such Antibodies to GI for further analysis directed to
the development of characterization and validation data.
(2) With respect to each Antibody delivered pursuant to subparagraph (a)
of this Section 3.4, each Party shall, on a quarterly basis, supply to
the RMC the characterization/validation data derived from such Party's
analysis of the Antibody.
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3.5 Phase III: Decision to Engineer Collaborative Antibodies.
(1) Promptly following its review and analysis of the data
contemplated by Section 3.4(b) hereof, the RMC shall promptly
select those Antibodies to be further engineered by CAT pursuant
to subparagraph (b) of this Section 3.5.
(2) With respect to each Antibody selected by the RMC pursuant to
subparagraph (a) of this Section 3.5, CAT shall, pursuant to the
Engineering Criteria, make diligent efforts to engineer such
Antibodies into Collaborative Abs.
(3) CAT shall devote at least [***] to the engineering work
contemplated by subparagraph (b) of this Section 3.5, at a cost
to CAT of [***] (the "Engineering Cost"). GI shall be obligated
to reimburse CAT [***] and such reimbursement shall be due within
thirty (30) days of GI's receipt of a quarterly invoice from CAT.
3.6 Phase IV: Introduction of Collaborative Abs to Selection Pool.
With respect to each Collaborative Ab and upon completion of the
engineering (as contemplated by Section 3.5(b)) of such Collaborative
Ab, CAT shall promptly submit to the RMC each Collaborative Ab and all
related data. The RMC shall promptly evaluate each such Collaborative
Ab to determine if the Engineering Criteria has been met. Upon a
determination by the RMC that the Engineering Criteria has been
satisfied, such Collaborative Ab shall be introduced into the
Selection Pool for selection by the Parties pursuant to Article 9
("Introduction Date").
Upon a determination by the RMC that the Engineering Criteria has not
been met, the RMC shall determine the appropriate disposition of such
Collaborative Ab.
4. Intellectual Property.
(1) Except as provided in subparagraphs (b), (c), (d) and (e) of this
Article 4, the entire right, title, and interest in all
discoveries, improvements, processes, formulas, data, inventions,
know-how, and trade secrets, patentable or otherwise, arising
from the Product Collaboration, shall be owned jointly by the
Parties ("Product Collaboration IP").
Each party shall promptly disclose to the other party the making,
conception, or reduction to practice of all Product Collaboration
IP.
(2) Product Collaboration IP shall not include GI Background IP, GI
Background Technology, CAT Background IP or CAT Background
Technology.
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(3) GI Background IP and GI Background Technology shall be owned by
GI and CAT Background IP and CAT Background Technology shall be
owned by CAT.
(4) Except as expressly provided herein, nothing in this Agreement
transfers or licenses any right, title or interest in and to GI
Background IP, GI Background Technology, CAT Background IP or CAT
Background Technology.
(5) Any Improvements to Background IP (GI or CAT Background IP, as
appropriate), shall be owned by the party who owns the underlying
CAT or GI Background IP.
(6) Each Party shall, pursuant to Article 10, have the first option
to exclusively license the other Party's rights and interests in
and to Product Collaboration IP.
(7) Except as expressly provided herein, nothing in this Agreement
transfers or licenses to a Party any right, title or interest in
and to the Independent Developments of the other Party.
5. Term of Product Collaboration.
(1) Except as otherwise provided in this Agreement, the term of the
Product Collaboration shall commence on the Effective Date and
expire on the date three (3) years thereafter, provided, if there
are any Collaborative Ab(s) in the Selection Pool at such time,
the term of the Products Collaboration shall be extended until
the later of:
(1) such time when the last of such Collaborative Ab(s) is
selected pursuant to Article 9, or
(2) the end of the Product Collaboration Term as determined
pursuant to subparagraph (b) hereof, as appropriate.
(2) If at the end of the Product Collaboration Term an Antibody(ies)
are, pursuant to Section 3.5(b), being engineered by CAT, the
Product Collaboration shall be extended to the extent necessary
to
(1) complete engineering of such Antibodies and
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(2) complete selection of any corresponding Collaborative Abs,
pursuant to Article 9. The disposition of all other
Antibodies will be determined on a case by case basis by the
RMC. Upon the expiration of the Product Collaboration and
subject to any rights granted pursuant to Article 10 hereof,
each Party shall retain a royalty free research license
(with right of sublicense to Affiliates) to any and all
Product Collaboration IP.
6. Termination of Product Collaboration: Effect of Termination.
6.1 Termination for Cause. The Product Collaboration may be terminated by
notice by either Party at any time during the term of the Product
Collaboration if the other Party is in breach of its material
obligations under the Product Collaboration by reasons and causes
within its control, and has not, to the extent curable, cured such
breach within sixty (60) days following written notice requesting cure
of the breach.
6.2 Effect of Termination.
(1) In the event GI terminates this Product Collaboration pursuant to
Section 6.1, all of CAT's rights in and to Product Collaboration
IP shall hereby terminate and GI shall retain sole ownership of
all Product Collaboration IP.
(2) In the event CAT terminates this Product Collaboration pursuant
to Section 6.1, all of GI's rights in and to Product
Collaboration IP shall hereby terminate and CAT shall retain sole
ownership of all Product Collaboration IP.
(3) Notwithstanding anything herein to the contrary, expiration or
termination of the Product Collaboration shall not relieve the
parties of any obligation, right or license accruing prior to
such expiration or termination and all confidentiality
obligations shall survive this Agreement for five (5) years.
7. Supply of Materials. Each Party shall use reasonable and diligent efforts
to supply to the other Party such reasonable quantities of Additional
Target Antigens, Accepted Antigens, Collaborative Abs and other materials
in that Party's possession as the Parties may agree are reasonably required
to carry out their respective obligations under this Agreement.
8. Work with Academic Collaborators. Either Party shall be permitted to
transfer Additional Target Antigens, Accepted Antigens, Antibodies,
Collaborative Abs and related Confidential Information (collectively,
"Product Collaboration information") to academic third party collaborators,
(a) pursuant to the terms set forth in this Article 8 and (b) only to the
extent necessary to effect the Product Collaboration.
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8.1 No Right of Further Transfer. The academic collaborator shall not have
the right to transfer any Product Collaboration Information to any
third party.
8.2 Permitted Use. The academic collaborator's use of Product
Collaboration Information shall be (a) clearly set forth in a written
collaboration agreement ("Collaboration Agreement") and (b) limited to
laboratory research and preclinical development work.
8.3 Confidentiality. Any Product Collaboration Information transferred to
an academic collaborator shall be transferred under confidentiality
and publication provisions which are no less restrictive than those
set forth in his Agreement.
8.4 Disposition of Intellectual Property. In each Collaboration Agreement,
GI and CAT, as applicable, shall obtain from the academic
collaborator:
(1) an automatic, irrevocable, non-exclusive royalty-free license
(with right of sublicense), to all know-how, inventions and
discoveries (patentable and unpatentable) made by the academic
collaborator ("Academic IP"), or
(2) joint ownership of all such Academic IP, and
---
(3) an option to negotiate an exclusive, royalty bearing license
(with right of sublicense) to all Academic IP.
8.5 Identity of Academic Collaborator. At the request of the other Party,
each Party shall, under confidentiality, disclose (to the extent
permitted under its third party agreement), the identity of any
academic collaborator.
9. Ab Selection. GI and CAT may each select Available Abs, pursuant to the
following procedures:
9.1 Selection of First Available Ab: Firm Offer. At any time following the
Introduction Date of the First Available Ab, GI or CAT may submit in
writing to the other Party ("Recipient Party") a firm offer for any
Available Ab ("Firm Offer"). Such Firm Offer shall include [***] to
secure, pursuant to Article 10 hereof, exclusive rights in and to such
Available Ab for the development and commercialization of Therapeutic
Licensed Product(s) and Diagnostic Licensed Product(s).
9.2 Election to Match Firm Offer.
(1) Within [***] of a Recipient Party's receipt of a Firm Offer, such
Recipient Party may by written notice ("Option Acceptance") to
the Offering Party,
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elect to match the Firm Offer by agreeing to promptly pay the
Offering Party an amount equal to the Option Price. In the event
Recipient Party elects to match the Firm Offer, Recipient Party
shall, pursuant to Section 10.1 and as consideration for Offering
Party's grant of it rights and interests in and to such Available
Ab, pay to Offering Party an amount equal to the Option Price
("Option Payment").
(2) In the event Recipient Party does not, pursuant to subparagraph
(a) of this Section 9.2, send such Option Acceptance to Offering
Party, the Offering Party shall promptly pay the Option Payment
to the Recipient Party. As consideration for payment of the
Option Payment, Recipient Party shall, pursuant to Section 10.1,
grant to Offering Party all of Recipient Party's rights and
interests in and to the Available Ab selected.
9.3 Subsequent Ab Selections. GI and CAT shall alternate selections of
Available Abs (after the First Available Ab), pursuant to the
following procedures:
(1) At any time following a Party's initial selection of an Available
Ab pursuant to Section 9.2 hereof (the "Purchasing Party"), the
other Party ("Non-Purchasing Party") shall, during the Exclusive
Selection Period (defined below), have the exclusive opportunity
to select an Available Ab from the Selection Pool by (i) giving
written notice to the Purchasing Party of its intention to make a
selection ("Notice of Intent") and (ii) making such selection,
provided, however, at any time following the date [***] from the
Option Payment Date ("Exclusive Selection Period"), such
exclusive opportunity shall become non-exclusive and the
Purchasing Party may also submit a Notice of Intent with respect
to any Available Ab. In the event there are no Available Abs
remaining in the Selection Pool as of the Option Payment Date,
the term of the Exclusive Selection Period shall be [***] from
the Introduction Date of the next Available Ab.
If, following the Exclusive Selection Period, the Purchasing
Party delivers a Notice of Intent, the Non-Purchasing Party shall
have [***] from the date of its receipt of such Notice of Intent
("Selection Period") to select an Available Ab.
(2) In the event the Non-Purchasing Party selects an Available Ab
pursuant to subparagraph (a) of this Section 9.3, the Purchasing
Party shall, pursuant to Section 10.1 hereof, grant to the Non-
Purchasing party all of its rights and interests in and to the
selected Available Ab.
(3) In the event the Non-Purchasing Party does not select an
Available Ab within the Selection Period pursuant to subparagraph
(a) above, the Purchasing party
15
shall have [***] from the end of such Selection Period to select
an Available Ab from the Selection Pool.
(1) If during this [***] period, such Purchasing Party gives the
Non-Purchasing Party written notice of its selection of an
Available Ab, the Non-Purchasing Party shall, pursuant to
Section 10.1, hereof, grant to such Purchasing Party, all of
its rights and interests in and to such selected Available
Abs.
(2) If during this [***] period, such Purchasing Party fails to
provide the Non-Purchasing Party written notice of its
selection of an Available Ab, the Non-Purchasing Party's
right to select an Available Ab is restored and for the next
[***] period, such Non-Purchasing Party shall have an
exclusive opportunity to select an Available Ab.
(4) Thereafter, each Party shall alternate in their selection of
Available Abs. If it is a Party's turn to select an Available Ab,
it may do so at any time, provided such selection is made, as
applicable within [***].
(1) of the previous selection of an Available Ab, if at such
time, there exist Available Ab(s) in the Selection Pool or,
(2) Introduction Date of the next Available Ab, if at such time,
no Available Ab(s) are in the Selection Pool.
9.4 References to Days and Dollars. Unless otherwise specifically set
forth herein, all references to "days" in this Agreement shall refer
to calendar days and all references to "dollars" shall refer to United
States currency.
10. Product Collaboration License Grant.
10.1 Therapeutic Licensed Products. (a) Upon a Party's (the "Exclusively
Licensee") payment of an Option Payment for an Available Ab pursuant
to Section 9.2, or selection of an Available Ab pursuant to Section
9.3, the other Party ("Granting Party") shall, with respect to such
Available ▇▇ ▇▇▇▇▇ to such Exclusive Licensee:
(1) A worldwide exclusive license (with rights of sublicense) to
all of Granting Party's rights and interests in and to
Product Collaboration IP,
(2) A worldwide, non-exclusive license (with right of
sublicense) to all of Granting Party's rights and interests
in and to the Granting Party's Background IP and Background
Technology as is necessary to
16
develop, make, have made, use, sell, offer to sell or
import Therapeutic Licensed Product(s), and Diagnostic
Licensed Products, provided however, any rights granted by
----------------
GI to CAT pursuant to this Section 10.1 are:
1. subject to CAT's obligations and GI's rights pursuant to
Article 12 and
2. includes only those [***] which GI is permitted to license
under its existing arrangements. GI acknowledges that,
with respect to such arrangements, it shall use good faith
efforts to remove restraints on its ability to sublicense
[***] hereunder.
(b) Additionally, Granting Party shall promptly transfer to the
Exclusive Licensee Party all physical embodiments of Product
Collaboration IP, including all information, improvements,
processes, formulas, data, inventions, know-how, and trade
secrets.
10.2 Non-Ab Licensed Product(s). Pursuant to the terms of the Product
Collaboration, from time to time each Party may, pursuant to Section
3.3(b), submit Additional Target Antigens to the Product
Collaboration. For purposes of this Section 10.2, the Party who
submits the Additional Target Antigen to the Product Collaboration
shall be called the Target Antigen Provider.
(1) Option to Exclusive License. Each Party grants the Target Antigen
Provider an option to license exclusively such rights as are set
forth in subparagraph (b) of this Section 10.2. Notwithstanding
anything herein to the contrary, at any time from the Effective
Date to the date [***] following the end of the term of the
Product Collaboration, a Target Antigen Provider may exercise
such option by (I) written notice to the other Party and (II)
acceptance of the obligations set forth under this Agreement with
respect to Licensed Product(s).
(2) License Grant. Upon exercise by a Target Antigen Provider ("Non-
Ab Licensee") of an option pursuant to subparagraph (a) above,
the other Party ("Granting Party") shall grant to such Non-Ab
Licensee a worldwide, exclusive license (with right of
sublicense) to all of Granting Party's rights and interests in
and to Product Collaboration IP:
to develop, make, have made, use, sell, offer to sell or import
Non-Ab Licensed Product(s).
17
(3) Royalties. In the event a Party commercializes a Non-Ab Licensed
Product, such Party shall, for each Non-Ab Licensed Product, pay
to the other Party on a country-by-country basis, royalties in an
amount equal to [***] of Net Sales of Non-Ab Licensed Products,
the sales of which would, but for the license hereunder, infringe
Valid Patent Rights in the country of sale.
Royalties with respect to Non-Ab Licensed Product(s) shall be
payable from the Date of First Commercial Sale until the
expiration of the last Valid Patent Right, provided:
(1) only one royalty shall be due with respect to the same unit
of Non-Ab Licensed Product, and
(2) no royalties shall accrue on the disposition of Non-Ab
Licensed Product in reasonable quantities by a Party or its
sublicensees as samples (promotion or otherwise) or as
donations (for example, to non-profit institutes or
government agencies for a non-commercial purpose).
(4) Third Party Licenses . In the event that one or more patent
licenses from third parties are required by a Party or its
sublicensee in order to develop, make, have made, import, use, or
sell Non-Ab Product(s) ("Third Party Licenses"), any
consideration actually paid under such Third Party License(s) by
a Party or its sublicensee, shall not be creditable against any
royalty payments due under this Agreement.
10.3 Payments Due Third Parties.
(1) In the event a Non-Ab Licensee exercises a license pursuant to
Section 10.2, thereafter such Non-Ab Licensee shall, subject to
subparagraphs (b) and (c) of this Section 10.3, be responsible
for paying [***] on sales or other dispositions of Non-Ab
Licensed Product(s), whether such payments are required to be
paid directly by Non-Ab Licensee or are required to be paid
directly by Granting Party [***].
(2) All required fees and royalties relating to CAT Background IP and
Technology and payable under agreements entered into by CAT as of
the date of this Agreement are set forth in Exhibit B.
(3) Upon receipt of the written notice set forth in Section 10.2(a),
Granting Party shall advise Non-Ab Licensee in writing as to
whether or not the royalties and fees ("Third Party Obligations")
set forth in Exhibit B or any additional Third Party Obligations
will attach to the Non-Ab Licensed Product which Non-Ab
18
Licensee is seeking to license. With respect to solely
those sublicenses that Non-Ab Licensee elects to have
granted to it by Granting Party, Non-Ab Licensee shall
agree to the Third Party Obligations incident to such
sublicenses and thereafter shall be responsible for
paying any and all fees and royalties due such third
parties on sales of Non-Ab Licensed Product(s), whether
such payments are required to be paid directly by
Granting Party to such Third Party.
11. Product Collaboration Benchmark Payments. In the event a Party develops
and/or commercializes a License Product(s), such Party shall be required to
make the following benchmark payments to the other Party with respect to
each Licensed Product(s):
Therapeutic Licensed Product(s)
------------------------------
Initiation of Phase I/II [***]
Initiation of Phase III [***]
First regulatory filing (BLA or equivalent)
in any Major Market [***]
First Approval of a marketing application
in any Major Market [***]
Provided, however, the benchmark payment of [***] in respect of initiation
of Phase I/II shall not be payable by CAT.
Diagnostic Licensed Product(s)
------------------------------
IND or IDE or equivalent [***]
PMA or BLA or equivalent [***]
Regulatory marketing Approval [***]
With respect to each Licensed Product, a benchmark payment shall be payable
only upon the initial achievement of such benchmark and no amounts shall be
due for subsequent or repeated achievement of such milestone. All benchmark
payments set forth in this Article II shall be made within thirty (30) days
of the related event.
12. CAT's Conditional Right of Sublicense:
12.1 GI Option Right.
(1) In the event CAT develops a Licensed Product following completion
of Phase II clinical trials in the first Major Market Country, GI
shall have the exclusive option to negotiate an agreement under
which CAT shall grant to GI a worldwide, exclusive, sublicensable
license under CAT's rights under
19
Product Collaboration IP and under Product Collaboration
Technology relating to the Licensed Product, to develop,
manufacture, use and sell such Licensed Product. CAT shall
(1) pursuant to applicable laws, provide to GI a comprehensive
Phase II Clinical Trial written report setting out the
data, including, but not limited to, patient
characteristics (e.g. demographics), patient
inclusion/exclusion criteria, study design (e.g.
randomized, blinded, unblinded, etc.), protocol, results
of the primary efficacy outcome by treatment and adverse
effects/events by treatment, patient drop-out data, and
statistical data, all in sufficient detail to enable GI to
reasonably enter such Licensed Product into Phase III, and
(2) disclose to GI all required fees and royalties, if any,
payable under agreements entered into by CAT as of such
filing date and all third party rights under option or
license to CAT which specifically relate to the Licensed
Product, so GI can undertake a reasoned evaluation of its
interest in exercising its option under this Section 12.1.
12.2 GI Exercise. If GI exercises its option to negotiate an agreement
with CAT under Section 12.1, such agreement shall be negotiated in
accordance with the following terms and conditions:
(1) GI will have [***] after receiving a comprehensive Phase II
Clinical Trial written report from CAT to negotiate in good
faith with CAT and provide CAT an offer of terms to the
Licensed Product. If, pursuant to a binding letter of intent,
the parties can agree to terms for such Licensed Product, GI
shall take over all future development of the Licensed Product,
and CAT shall grant to GI the license referred to in Section
12.1.
Any offer made by GI pursuant to this Section 12.2(a) shall at
a minimum provide for royalties sufficient to discharge any
required third party royalties disclosed by CAT pursuant to
Section 12.1(a)(ii).
(2) If CAT is not satisfied with the GI offer made in accordance
with Section 12.2(a), CAT shall have [***] to seek an
alternative partner to develop the Licensed Product and enter
into a binding letter of intent with such partner in accordance
with the following provisions.
(1) Benchmark payments offered by any third party and accepted
by CAT for the Licensed Product must [***]. The discount
rate [***] will be the Citicorp USA Inc. prime rate at
time of negotiation [***]. For the purpose of calculating
[***] under this Section 12.2(b) the following
20
timing definitions will apply: (a) Phase III Clinical Trials
shall be [***] the completion and receipt by GI of the Phase
II Clinical Trial report, (b) registration submission will
occur [***] and, (c) registration approval will occur [***].
(2) Royalty rates offered by any third party and accepted by CAT
must exceed those offered by GI to CAT by [***] for example,
if GI offers [***], then royalty rates offered by any third
party and accepted by CAT must exceed [***].
(3) If a third party offer for the Licensed Product exceeds the
GI offer by the guidelines outlined in this Section 12.2 and
is accepted by CAT, GI shall receive from CAT the benchmark
payments and running royalty that would be owed by CAT to GI
hereunder as if CAT were to have developed and sold the
Licensed Product. GI shall forego any other rights in such
Licensed Product.
(3) If CAT cannot exceed the GI offer by the guidelines outlined in
this Section 12.2, then CAT shall accept the GI offer.
(4) Any offer made by GI pursuant to this Section 12.2 shall be deemed
Confidential Information and shall not be disclosed to any third
parties.
12.3 In the event that GI does not exercise its option to negotiate an
agreement with CAT under Section 12.1, and CAT therefore seeks a
partner after the initiation of Phase III Clinical Trials for global or
local rights, GI shall be notified and allowed a reasonable first
opportunity to negotiate in good faith to acquire such rights.
13. Development and Commercialization of Licensed Products.
(1) Each Party shall use reasonable efforts, consistent with the usual
practices followed by such Party in pursuing drug development and
commercialization, at its own expense, to develop and
commercialize its Licensed Product(s) on a commercially reasonable
basis in such countries in the world where in the Party's opinion,
it is commercially viable to do so.
(2) The obligations of a Party with respect to any Licensed Product(s)
under subparagraph (a) above is expressly conditioned upon the
continuing absence of any adverse condition or event relating to
the safety or efficacy of the Licensed Product(s), and such
obligations of a Party shall be delayed or suspended so long as in
such Party's opinion any such condition or event exists.
21
14. Product Collaboration Royalties.
14.1 Payment. In the event a Party commercializes a Licensed Product(s),
such Party shall, for each Licensed Product(s), pay to the other Party
royalties on a country-by-country basis in an amount equal to:
(1) [***] of Net Sales of Therapeutic Licensed Products, and
(2) [***] of Net Sales of Diagnostic Licensed Products.
Royalties with respect to Licensed Product(s) shall be payable for the
later of a period:
(a) of ten (10) years from the Date of First Commercial Sales or
(b) from the Date of First Commercial Sales to the last to expire of
the Valid Patent Rights of the CAT Antibody Patents, on such
sales that, but for the license granted pursuant to Section 10.1,
would infringe such CAT Antibody Patents, provided
(1) only one royalty shall be due with respect to the same unit
of Licensed Product, and
(2) no royalties shall accrue on the disposition of Licensed
Product in reasonable quantities by a Party or its
sublicensees as samples (promotion or otherwise) or as
donations (for example, to non-profit institutes or
government agencies for a non-commercial purpose.)
14.2 Third Party Licenses.
(1) MRC and Dyax Licenses. Under the terms of the MRC License (as
---------------------
defined in Exhibit B) and the Dyax License (as defined in Exhibit
B), CAT represents that GI, as consideration for GI's rights
under such licenses, is obligated to pay CAT (for the benefit of
Dyax and MRC) certain royalties on Net Sales of Licensed Products
and Research Products ("GI/MRC/Dyax Sublicenses Royalties" at the
royalty rates set forth in Exhibit B). In addition to the
royalties due pursuant to Section 14.1, GI hereby agrees to (a)
pay to CAT such GI/MRC/Dyax Sublicensee royalties as are due
under the terms of the MRC and Dyax License and (b) make such
payments directly to CAT (for the benefit of Dyax and MRC).
22
As provided in Section 15.7, for Research Products, such GI/MRC/Dyax
Sublicense Royalties are included in the royalty amounts set forth in
subparagraphs (a) and (b) of Section 15.7.
(2) CAT Representations. CAT hereby agrees that during the term of
this Agreement:
(1) With respect to royalty payments payable by GI hereunder, it
will apply all applicable offsets available under the MRC
and/or Dyax Agreement
(2) the Dyax and/or MRC License shall not be amended or modified
[***] and
(3) a) in the event the Dyax and/or MRC license are amended or
modified to create more favorable GI/MRC/Dyax Sublicense
Royalties than those existing on the Effective Date, such
more favorable terms shall be offered to GI or b) in the
event more favorable commercial terms with respect to the
Dyax and/or MRC License are available to other licensees of
CAT ("Other Licensee"), CAT shall be obligated to use
diligent efforts to cause such more favorable terms to be
offered to GI. GI shall have the right to accept such more
favorable terms or retain the terms set forth in this
Agreement. b) With respect to (b) of this subparagraph
(iii), such notification shall set forth the more favorable
terms, as well as any less favorable terms and conditions
agreed upon by the Other Licensee in exchange for such more
favorable terms. GI shall have the right to accept or reject
all of the varying terms, but shall not have the right to
accept solely the more favorable GI/MRC/Dyax Sublicensees
Royalties.
Subject to (a) CAT obligations as set forth in subparagraphs (i),
(ii), and (iii) of this Section 14.2(b) and (b) GI's rights to
the MRC License and Dyax License granted under this Agreement,
CAT may, in its sole discretion, modify or amend such MRC and/or
Dyax License(s), provided no such modification or amendment shall
adversely affect GI's rights hereunder.
(3) Third Party Licenses Relating to CAT Antibody Patents. In the
-----------------------------------------------------
event CAT determines in its sole discretion during the term of
the Product Collaboration to enter into one or more additional
third party patent licenses ("Third Party Antibody License(s)"),
which, but for such licenses, the practice hereunder of the
technology claimed by the CAT Antibody Patents, would infringe
such Third Party Antibody License(s), CAT shall notify GI of
23
any additional royalties payable by sublicensees under such Third
Party Antibody License(s). The first [***] on Net Sales of
Licensed Products, due under such Third Party Antibody
License(s), shall be borne by CAT and such royalties in excess of
[***] shall be subject to the provision of Section 14.2(c).
(4) Other Third Party Licenses. In the event that one or more patent
--------------------------
licenses from third parties (excluding MRC and Dyax Licenses and
Third Party Antibody Licenses) are required by a Party or its
sublicense in order to develop, make, have made, import, use, or
sell Licensed Product(s) ("Other Third Party Licenses"), any
consideration actually paid under such Third Party License(s) by
a Party or its sublicense, shall not be creditable against any
royalty payments due under this Agreement.
14.3 Reporting and Auditing (or Payment) Reports and Payment. Each Party
shall deliver to the Party to which royalties are owed, within sixty
(60) days after the end of each calendar quarter, a written report
showing its computation of royalties due under this Agreement upon Net
Sales by such Party, and sublicensees during such calendar quarter.
All Net Sales shall be segmented in each such report according to
sales by such Party, and such sublicensee, as well as on a country-by-
country basis, including the rates of exchange used to convert such
royalties to United States Dollars from the currency in which such
sales were made. Simultaneously with the delivery of each such report,
the paying Party shall tender payment in United States Dollars of all
royalties shown to be due therein.
For purposes hereof, the rates of exchange to be used for converting
royalties hereunder to United States Dollars shall be the closing
price published for the purchase of United States Dollars in the East
Coast Edition of the Wall Street Journal for the last business day of
the calendar quarter for which payment is due.
14.4 Foreign Royalties. Where royalties are due hereunder for sales of
Licensed Products in a country where, by reason of currency
regulations or taxes of any kind, it is impossible or illegal for such
Party or its sublicensee to transfer royalty payments to the licensor
Party for Net Sales in that country, such royalties shall be deposited
in whatever currency is allowable by the person or entity not able to
make the transfer for the benefit or credit of the licensor Party in
an accredited bank in that country that is reasonably acceptable to
the licensor Party.
14.5 Taxes. Any and all income or similar taxes imposed or levied on
account of the receipt of royalties payable under this Agreement which
are required to be withheld by a Party shall be paid by such Party or
its sublicensees on behalf of the licensor Party and shall be paid to
the proper taxing authority. Proof of payment shall be secured and
sent to the licensor Party by such Party or sublicensees as evidence
of
24
such payment in such form as required by the tax authorities having
jurisdiction over such Party or its sublicensees. Such taxes shall be
deducted from the royalty that would otherwise be remittable by the
Party or its sublicensees.
14.6 Records. Each Party shall keep, and shall require all sublicensees to
keep, for a period of at least three (3) years, full, true and
accurate books of accounts and other records containing all
information and data which may be necessary to ascertain and verify
the royalties payable thereunder. During the term of this Agreement
and for a period of three (3) years following its termination, each
Party shall have the right from time to time (not to exceed once
during each calendar year) to inspect in confidence, or have an
agent, accountant or other representative inspect in confidence, such
books, records and supporting data.
15. Contract Research Program - General.
The following provisions of this Article 15 shall be applicable to the
Contract Research Program:
15.1 General. GI and CAT shall engage in a Contract Research Program upon
the terms and conditions set forth in this Agreement. The activities
which may be undertaken in the course of the Contract Research
Program are set forth in this Article 15, which may be amended from
time to time upon the mutual agreement of the Parties.
The Contract Research Program consists of the following components:
a) Section 16 - ProAb Services,
b) Section 17 - SKIM Services,
c) Section 18 - ProAb/SKIM Installation and Support
d) Section 19 - Contract FTE Services,
e) Section 20 - CAT Library Services, and
f) Section 21 - Optional Antibody Engineering Services
15.2 Conduct of Contract Research Program. GI and CAT shall conduct the
Contract Research Program in good scientific manner, and in
compliance in all material respects with all requirements of
applicable laws, rules and regulations and all applicable good
laboratory practices to achieve their objectives efficiently and
expeditiously. GI and CAT each shall use commercially reasonable and
diligent efforts in undertaking the work set out in the Contract
Research Program.
15.3 Intellectual Property. Except as provided in Article 20 hereof, the
entire right, title and interest in all discoveries, improvements,
processes, formulas, data (including, but not limited to all ICC
Data), inventions, know-how, and trade secrets, patentable or
otherwise, arising from the Contract Research Program ("Contract
IP"), shall be
25
owned by GI. CAT shall promptly disclose to GI the making, conception
or reduction to practice of all Contract Research Program IP.
Improvements to Background IP (GI or CAT Background IP, as
appropriate) shall not be included in Contract IP. GI shall have the
right to seek or continue to seek or maintain patent prosecution on
all Contract IP.
15.4 Contract Research Program Term. Except as otherwise provided in this
Agreement, the term of the Contract Research Program shall commence on
the Effective Date and continue for the later of (a) three years or
(b) completion by CAT of all of its performance obligations undertaken
pursuant to the Contract Research Program. GI may extend the term of
the Contract Research Program for an additional year by giving [***]
written notice to CAT.
15.5 Development and Commercialization of Research Product(s).
(1) GI shall use reasonable efforts, consistent with its usual
practices in pursuing drug development and commercialization, at
its own expense, to develop and commercialize Research Product(s)
on a commercially reasonable basis in such countries of the world
where in GI's opinion, it is commercially viable to do so.
(2) The obligations of GI with respect to any Research Product(s)
under subparagraph (a) above are expressly conditioned upon the
continuing absence of any adverse condition or event relating to
the safety or efficacy of the Research Product(s), and such
obligation shall be delayed or suspended so long as in GI's
opinion any such condition or event exists.
(3) Notwithstanding anything in this Agreement to the contrary, in
the event GI breaches its obligations under this Section 15.5, GI
shall grant to CAT a non-exclusive patent license to develop and
commercialize such Research Product. CAT's sole remedy with
respect to such Research Product, shall be this grant of a non-
exclusive patent license.
15.6 Contract Research Benchmark Payments. In the event that GI develops
and/or commercializes a Research Product(s), GI shall be required to
make the following benchmark payments to CAT with respect to each
Research Product:
Therapeutic Research Product(s)
-------------------------------
License Fee [***]
Initiation of Phase I/II [***]
Initiation of Phase III [***]
First Regulatory Filing in any Major Market [***]
26
First Approval of a marketing application
in any Major Market [***]
[***] of all such benchmark payments (excluding License Fees) shall be
creditable against royalties due with respect to such Research Products(s).
The License Fee shall not be owing if GI elects to purchase Ab engineering
services under the Contract Research Program.
Diagnostic Research Product(s)
------------------------------
IND or IDE or equivalent [***]
PMA or BLA or equivalent [***]
Regulatory marketing Approval [***]
With respect to each Research Product, a benchmark shall be payable only
upon the initial achievement of such benchmark and no amounts shall be due
for subsequent or repeated achievement of such milestone. All benchmark
payments set forth in this Section 15.6 shall be made within thirty (30)
days of the related event.
15.7 Contract Research Royalties. In the event GI commercializes a
Research Product(s), such Party shall, for each Research
Product(s), pay to CAT royalties on a country-by-country basis in
an amount equal to:
(1) Therapeutic Research Products. A royalty totaling [***] of Net
-----------------------------
Sales of Therapeutic Research Products, [***].
(2) Diagnostic Research Products. A royalty totaling [***] of Net
----------------------------
Sales of Diagnostic Research Products, [***].
Royalties with respect to Research Product(s) shall be payable for the later of:
(a) a period of ten (10) years from the Date of First Commercial Sale or (b) a
period from the Date of First Commercial Sales to the last to expire of the
Valid Patent Rights of the CAT Antibody Patents, on such sales that, but for the
rights granted by CAT to GI under such CAT Antibody Patents, would infringe such
CAT Antibody Patents, provided
(1) only one royalty shall be due with respect to the same
unit of Licensed Product, and
(2) no royalties shall accrue on the disposition of Research
Product in reasonable quantities by a Party or its
sublicensees as samples (promotion or otherwise) or as
donations (for example, to non-profit institutes or
government agencies for a non-commercial purpose).
27
15.8 Third Party Licenses.
(1) CAT represents that as of the Effective Date, to the best of its
knowledge, there are no Third Party Licenses (defined below)
which are needed by GI in order to develop, make, have made,
import, use or sell Research Products.
(2) Notwithstanding anything herein to the contrary, in the event
that one or more additional third party licenses are required by
GI or its sublicensee in order to develop, make, have made,
import, use or sell Research Products ("Third Party Licenses")
because absent such Third Party Licenses, the practice of the
technology covered by the CAT Antibody Patents would infringe the
granted patent rights of such Third Party Licenses, any royalty
payments due third parties under such Third Party Licenses shall
be
(1) [***], and
(2) creditable against royalties due CAT pursuant to Section
15.7, provided however, under no circumstances shall the
royalty payment due CAT be less than [***] of Net Sales on
Research Products or [***] on Diagnostic Products.
Further provided, it is understood by the Parties that the royalty
------- --------
rates set forth in this subparagraph (ii) ("Minimum Rate") include and
are based on the GI/MRC/Dyax Sublicense Royalty existing on the
Effective Date and that reductions in such GI/MRC/Dyax Sublicensee
Royalty pursuant to Section 14.2 hereof, shall result in a
corresponding reduction in the Minimum Rate, however, under no
circumstances shall the Minimum Rate be less than [***].
(3) Subject to subparagraphs (a) and (b) of this Section 15.8, In the
event that one or more additional patent licenses from third
parties are required by GI or its sublicensee in order to
develop, make, have made, import, use, or sell Research
Product(s) ("Future Third Party Licenses"), any consideration
actually paid under such Future Third Party License(s) by GI or
its sublicensee, shall not be creditable against any royalty
payments due under this Agreement.
15.9 Most Favored Customer. During the term of the Contract Research
Program CAT shall not offer to any third party more favorable terms
for the ProAb and/or SKIM Services provided under the Contract
Research Program that the terms available to GI.
28
15.10 Grant of CAT Contract Background IP. As consideration for payment by
GI to CAT of a License Fee (pursuant to Section 15.6), or purchase
by GI of Ab Engineering Services (pursuant to Section 21,) CAT
shall, with respect to the Research Product(s) for which such
License Fee or Ab Engineering Services applies, grant to GI a
worldwide, exclusive license (with right of sublicense) to all of
CAT's rights and interests in and to all CAT Contract Background IP
to develop, make, have made, use, sell, offer to sell or import
Research Product(s), provided however, such grant shall, to the
----------------
extent evidenced in its contemporaneous written records, be subject
to (a) any prior non-exclusive or exclusive grant by CAT of such
rights to third parties with respect to such Research Product(s) or
(b) CAT's exclusive right to continue any current bona fide internal
development project directed to the research, development and
commercialization of such Research Project.
16. Contract Research Program (Part I - ProAb Services).
16.0 Non-Exclusive Access. Subject to Section 15.10, the parties agree
that CAT shall provide ProAb to GI on a non-exclusive basis and that
during the term of the Contract Research, CAT may provide ProAb
services to third parties, including ProAb services on any Research
Antigens.
16.1 GI Antigen Delivery.
(1) Delivery. GI may deliver Ful Length Sequence or portions thereof
for up to [***] antigens ("Research Antigens") per quarter,
[***] will be Full Length Sequence.
(2) Limited Right of Non-Acceptance. CAT shall be obligated to
accept each Research Antigen delivered by GI and pursuant to
Section 16.2, generate Research Abs and ICC Data for such
Research Antigens, provided however, CAT shall not be obligated
to accept any Research Antigen if within [***] business days of
delivery of such Research Antigen by GI, as evidenced in its
contemporaneous written records, CAT correctly determines:
[***]
If during the term of the Product Collaboration, any of the above projects,
exclusive licenses or letter of intent terminate, GI's right to redeliver
and CAT's obligation to accept such non-accepted Research Antigen is
restored.
(3) Replacement and Non-Acceptance Credit. For each Research Antigen
CAT declines to accept pursuant to this Section 16.1, (i) GI
shall have an opportunity to present an additional Research
Antigen as a replacement, or
29
(ii) an amount [***] shall be credited against any amounts due
CAT pursuant to Section 17.2.
16.2 CAT Diligence. Subject to Section 16.1 hereof, CAT shall use
commercially reasonable and diligent efforts to generate Research Abs
and ICC Data for each of up to [***] delivered by GI to CAT each
quarter (the "Quarterly Maximum"), and with respect to each such
Research Antigen,:
(1) if GI delivers Research Antigen polypeptide sequence,
(1) CAT shall select [***]
(2) [***], or
(2) if GI delivers [***]
(3) if GI delivers [***]
(1) CAT shall [***], provided however,
(2) for purposes of calculating the Quarterly Maximum in this
Section 16.2, [***]
(4) CAT shall screen at least [***] Research Abs to each peptide
synthesized pursuant to this Section 16.2;
(5) CAT shall (i) maintain reasonable quantities of [***] and (ii)
screen such Research Abs against the ICC Tissue Panel;
(6) CAT shall develop a method to transmit ICC Data to GI
electronically; and
(7) Within seven (7) business days of a request from GI, CAT will
dispatch an aliquot of any Research Ab to GI, in a form such that
it can be used and propagated.
16.3 ProAb Minimum Performance Requirements.
(1) CAT shall test all Research Abs in a ELISA format in which the
protein or peptide immunogen is immobilized on the solid-phase. A
Research Ab will be deemed to have satisfied the "Minimum
Performance Requirements" if:
(1) [***]
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(2) [***]
(2) With respect to all Research Abs generated by CAT pursuant to
this Article 16, in any calendar quarter, [***]
(3) If during any quarterly period, any Research Abs fail to meet or
exceed the Minimum Performance Requirements, for such period, GI
research funding obligation shall be calculated as follows:
Payment due CAT equals:
[***]
(4) If with respect to any Research Antigen, CAT is unable to
generate any Research Abs satisfying the Minimum Performance
Requirements, GI shall be permitted to substitute such Research
Antigen with another Research Antigen, provided this right of
substitution shall only exist upon CAT's failure to satisfy its
performance obligations under subparagraph (a) of this Section
16.3.
17. SKIM Service and Fees.
17.1 General. GI may deliver the full-length sequences (or portions
thereof) of [***]. These are expected to be (but are not limited to
being) of non-human origin. CAT will generate antibodies against these
sequences, as specified in section 16.2(a) and (b), but will not
proceed further to the ICC analyses envisaged in that section. CAT
will dispatch an aliquot of each antibody to GI in a form that can be
used and propagated within [***] after the sequence has been delivered
by GI. In addition, CAT will maintain a reasonable quantity of each
antibody and dispatch aliquots to GI upon request. The Minimum
Performance Requirements and conditions specified in Section 16.3 for
ProAb will also apply to the antibodies generated in the SKIM service.
17.2 SKIM and ProAb Fees. Subject to Sections 16.1(c) and 16.3, in
consideration for its performance of (a) the SKIM services
contemplated by this Article 17 and (b) the ProAb services
contemplated by Article 16, GI shall pay CAT [***].
18. ProAb and SKIM Services - Installation and Technical Support.
18.1 Installation and Acceptance. CAT shall use commercially reasonable
efforts to install the Hardware/Software within 120 days of the
commencement of the Contract Research Program. Following such
installation, GI shall have forty-five (45) days to
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conduct acceptance testing. Such installation shall be deemed complete
upon written notice from GI to CAT indicating GI's acceptance of the
Hardware/Software.
In the event GI sends notice of non-acceptance to CAT, such non-acceptance
notice shall identify the manner in which the Hardware/Software fails to
satisfactorily perform, with sufficient specificity to permit CAT to
correct such nonconformity. CAT shall have up to thirty (30) days to cure
such deficiency. GI shall cooperate with CAT in correcting such deficiency.
In the event of any deficiency, GI shall have the right to withhold those
portions of the payments set forth in Article 17, allocable to ProAb
indicating that the Hardware/Software does not perform to GI's
satisfaction, CAT shall make reasonable efforts to promptly correct any
such deficiency.
18.2 User and Technical Support. GI shall be entitled to receive
technical support services from CAT during the term of the Contract
Research Program, as described below:
18.2.1 Remote System Support.
(1) User Support. CAT will provide, at its expense, remote
consultation regarding the Hardware/Software, comprised of
support, problem determination and resolution service by
telephone and electronic mail Monday-Friday, between the hours
of 9:00 A.M. and 5:00 P.M. UK time, provided, such support
shall be limited to [***] consultations per month ("Basic User
Support"). Additional user support is available at a cost of
[***] ("Additional User Support").
(2) Response Time. With respect to all Basic User Support and
Additional User Support, GI shall receive from CAT
(1) [***] response times for at least [***] of user
consultation requests and
(2) [***] response times for all such requests.
(3) Technical Support. CAT shall provide unlimited support relating
to Hardware/Software performance ("Tech Support"). In the event
of a request for Tech Support,
(1) for instances of non-performance of the Hardware/Software
(or portions thereof), within [***] of such request, CAT
shall cure such non-performance and
32
(2) for all other instances, CAT shall, within [***] of such
request, detail its proposed course of action for curing the
deficiency and shall cure such deficiency within [***]
thereafter.
18.3 On-site Training. Upon installation and a determination by GI pursuant to
subparagraph (a) of this Section 18.4 that the Hardware/Software conforms
to the Specifications, CAT shall provide (a) a total of [***] of on-site
end user training and (b) a total of [***] of administrator training (i.e.,
server side administration) at no additional charge to GI. Such training
session is "open attendance" and any GI selected personnel may participate.
Any training beyond the initial days of training described above, will be
provided at a cost of [***] per hour.
18.4 Improvements.
(1) Improvements to ProAb. CAT will during the term of the Contract
Research Program and the period [***] years thereafter, make available
to GI, of such improvements in the ProAb database technology relating
to GI's contemplated use of such technology hereunder, including, but
not limited to, improvements relating to Hardware/Software and the
production of information or analysis of data.
(2) Additional Technologies. In the event GI seeks from CAT software or
hardware not contemplated under this Article 18, CAT agrees to consult
with GI regarding such request at [***].
(3) Related Licenses. CAT hereby agrees that it has granted and/or will
cause to be granted to GI all licenses relating to Hardware/Software
that are necessary for GI to enjoy all of its rights concerning GI's
use of such Hardware/Software as contemplated under this Agreement
("Related Hardware/Software Licenses").
With respect to any such Related Hardware/Software Licenses, CAT represents
and warrants that
(a) GI's sublicensed rights under such licenses shall be perpetual and
irrevocable, in the absence of material breach by GI and
(b) the terms of such licenses shall be reasonable and shall not adversely
effect the rights of GI contemplated under the Contract Research Program
nor shall create any additional obligations not contemplated by the
Contract Research Program.
18.5 With respect to any Related Hardware/Software Licenses, GI represents and
warrants that it will use good faith efforts to accept the terms of such
licenses.
33
18.6 Indemnification. If any claim is made against GI asserting that any
technology, including but not limited to the Hardware/Software, ProAb
and SKIM technologies, infringes any patent, copyright or other
intellectual property right, CAT shall indemnify and defend GI with
respect to such claim.
19. Contract FTE Services.
(1) GI shall pay to CAT [***] in increments of [***] for [***] to be
supplied by CAT ("Research FTEs").
(2) Each Research FTE shall have appropriate technical credentials,
experience and knowledge to perform the work associated with the
Contract Research Program.
(3) The Research FTEs shall perform such work within the Contract
Research Program, as GI selects, in its sole discretion,
including, but not limited to, antibody engineering, Proximol
services and SKIM, provided however, such tasks shall exclude
performance of ProAb services.
20. Contract Research Program- Liberty Research License.
20.1
(1) Library Trial Use. At any time during the Contract Research
Program, GI may elect and CAT shall transfer and grant to GI a
license to utilize an aliquot of the CAT Library Technology
sufficient to perform selections against up to [***] ("Aliquot of
the CAT Library"), on a trial basis, pursuant to the terms of
this Section 20.1(a), for the sole purpose of GI determining GI's
ability to effectively manage and utilize such CAT Library
Technology consistent with GI's expectations ("Trial Use"). In
connection with such Trial Use, CAT hereby agrees to grant such
licenses and to transfer such know-how as is necessary for GI to
assess its liability to effectively and efficiently manage and
utilize the CAT Library Technology. As part of the Contract
Research Program, such Trial Use shall also be subject to Article
15 hereof. Upon GI's completion of any Trial Use, GI shall,
subject to subparagraph (b) of this Section 20.1, promptly return
the Aliquot of the CAT Library to CAT.
GI shall use the Aliquot of the CAT Library solely for the purposes
expressly set forth in this Section 21.1(a) and shall not distribute
such Aliquot of the CAT Library to any third party.
34
GI shall limit the use of the Aliquot of the CAT Library to GI
employees working on matters relating to the Contract Research Program
and maintain the same degree of security with respect to the Aliquot
of the CAT Library as is maintained by GI for its own similar
material.
GI shall comply with all applicable federal rules, regulations and
guidelines applicable to GI's use of the Aliquot of the CAT Library
and shall assume full responsibility for any claims or liabilities
arising solely from GI's use of the Aliquot of the CAT Library
hereunder.
(2) Library Option Right. At any time during the period eighteen (18)
months following the Effective Date until six (6) months
following the expiration of the term of the Contract Research
Program, GI may elect and CAT shall grant to GI the right to
utilize the CAT Library Technology for GI's research purposes in
GI's sites. Each such site license includes:
(1) transfer of the CAT Library Technologies necessary for GI to
screen CAT's phage display library for scFvs and
(2) a non-exclusive license in the field of human health to use
such scFvs and any derivatives of progeny thereof for GI's
research purposes (including its work with collaborators).
20.2 Exercise of Right. Upon exercise by GI of its rights set forth in
Section 20.1 above,
(1) CAT shall promptly transfer the CAT Library Technology to GI and
(2) shall provide five (5) days of onsite technical support and
training with respect to such CAT Library Technology.
20.3 License Payment. As full consideration for
(1) CAT's grant to GI of a non-exclusive, fully paid up, worldwide,
sublicensable (to GI collaborators for GI internal research only)
site license to use the CAT Library Technology for any research
purpose ("Site License"), and
(2) CAT's transfer and technical support of such CAT Library
Technology, as contemplated by Section 20.2 hereof, GI shall make
license payment(s) as follows:
[***]
35
With respect to such payments, as applicable, [***] shall be paid
to CAT upon exercise by GI of its right to the Site License and
[***] shall be payable upon completion of CAT's obligations as
set forth in Section 20.2 hereof.
20.4 Option for Commercial License. With respect to any Research Product(s)
arising from GI's use of the CAT Library Technology, GI retains an
option to exclusively license (with right of sublicense) from CAT all
of CAT's rights and interests (owned by or licensable by CAT) in and
to such intellectual property relating to CAT Library Technology
reasonably necessary for GI to develop, make, have made, use, sell,
offer to sell, or import such Research Products ("Library Option
Rights") provided however, GI' right to exercise such
----------------
an option is subject to [***].
20.5
(1) Library Options. Notwithstanding anything herein to the contrary,
GI may, in its sole discretion, request [***] of the options set
forth in Section 20.4 ("Library Options"), provided GI preserves
the right to exercise and CAT is obligated to grant, additional
Library Options so long as GI agrees with respect to such
Research Products, benchmark and royalty payments as provided in
Article 15.
(2) Exercise of Library Option. Subject to Section 15.10, GI may,
with respect to any Research Product, at any time following the
commencement of the Contract Research Program, exercise the
exclusive development and commercialization rights set forth in
Section 20.4, provided with respect to each such Research
Product, GI shall be obligated to pay benchmark and royalty
payments as provided in Article 15.
21. Optional Antibody Engineering Services.
21.1 Services. At any time during the term of the Contract Research Program
and with respect to any Antibody, GI may request and CAT shall provide
Ab Engineering Services pursuant to the terms set forth in Exhibit E.
21.2 No Concurrent Projects. Under no circumstances shall CAT, with respect
to engineering services procured by GI pursuant to this Article 21, be
obligated to undertake more than one Ab Engineering Project at a time.
21.3 Project Options. Notwithstanding anything herein to the contrary,
during the term of the Contract Research Program, GI may, in its sole
discretion, [***], provided, GI preserves the right to request and CAT
is obligated to grant additional Ab Engineering Projects, provided GI
agrees to compensate CAT pursuant to the terms set forth in Exhibit E.
36
22. Patent Prosecution and Infringement.
22.1 Responsibility for Patenting Product Collaboration IP.
(1) Product Collaboration IP. Subject to subparagraph (b) of this
Section 22.1, GI shall, at its expense, have the right to seek or
continue to seek or maintain Patent protection on any Product
Collaboration IP, in any country. If GI elects not to seek or
continue to seek or maintain patent protection on any such rights
in any country, CAT shall have the right, at its expense, to
file, procure and maintain in such countries patents on such
rights.
(2) Rights Upon Exclusive License Exercise. Notwithstanding anything
herein to the contrary, upon CAT's payment of an Option Payment
for an Available Ab pursuant to Section 9.2, or selection of an
Available Ab pursuant to Section 9.3,
(1) GI shall, with respect to the Product Collaboration IP to
which CAT has been granted an exclusive license, assign to
CAT (x) the right to seek or continue to seek or maintain
patent protection on any such Product Collaboration IP, in
any country and (y) with respect to such Product
Collaboration IP, to initiate an infringement or other
appropriate suit against any such third party and
(2) CAT shall reimburse GI for any and all patent related
expenses incurred by GI with respect to such licensed
Product Collaboration IP.
(3) CAT IP Rights. CAT shall have the right to seek or continue to
seek or maintain patent protection on any CAT IP in any country.
If CAT elects not to seek or continue to seek or maintain patent
protection on any CAT IP in any country, GI shall have the right,
at its expense, to file, procure and maintain in such countries
Patents on such CAT IP.
(4) Patent Corporation. Each Party shall advise the other applicable
Party of all decisions taken under this Article 22 in a timely
manner in order to allow the other applicable Party to protect
its rights under this Section. Each Party shall provide the other
applicable Party (or Parties) with copies of all substantive
communications from all patent offices regarding Intellectual
Property, promptly after the receipt thereof. Each Party shall
provide the other applicable Party with copies of all proposed
substantive communications to such patent offices regarding
Intellectual Property, in sufficient time before the due date in
order to enable the other applicable Party an opportunity to
comment on the content thereof. Each Party shall
37
make available to the other applicable Party, or its authorized
attorneys, agents or representatives, such of its employees whom
the other applicable Party, in its reasonable judgment, deems
necessary in order to assist it in obtaining patent protection
for the applicable Intellectual Property, in the event the Party
with first rights to seek or continue to seek or maintain Patent
protection on any such Intellectual Property chooses not to do
so. Each Party shall sign or use its best efforts to have signed
all legal documents necessary to file and prosecute patents or to
obtain or maintain Patents at no cost to the other Parties. [***]
22.2 Infringement.
(1) Notice. Each Party shall promptly report in writing to the other
Parties during the term of this Agreement any (i) known
infringement or suspected infringement of any of the Intellectual
Property or (ii) unauthorized use or misappropriation of the
Confidential Information by a third party of which it becomes
aware, and shall provide the other Parties with all available
evidence supporting said infringement, suspected infringement or
unauthorized use or misappropriation.
(2) First Right to Bring Suit. Subject to Section 22.1(b), GI shall,
in the first instance, have the right and the obligation to elect
whether or not to initiate an infringement or other appropriate
suit against any third party who at any time has infringed, or is
suspected of infringing, any of or of using without proper
authorization all or any portion of Product Collaboration IP. GI
shall give CAT sufficient advance notice of its intent to file or
not to file said suit and the reasons therefore to afford CAT an
opportunity to make suggestions and comments regarding such suit.
GI shall keep CAT promptly informed and shall from time-to-time
consult with CAT regarding the status of any such suit.
If, with respect to the Product Collaboration IP, GI elects not
to initiate an infringement or other appropriate suit against any
such third party, CAT, at its own expense, shall have the right
to initiate an infringement or other appropriate suit against any
such third party.
The Party bringing suit for infringement shall have the sole and
exclusive right to select counsel for any suit referred to in
this Section 22.2 and shall, except as provided below, pay all
expenses of the suit, including without limitation attorneys'
fees and court costs. If necessary, the other Party shall join
as a party to the suit but shall be under no obligation to
participate except to the extent that such participation is
required as the result of being a named party to the suit. Such
other Party shall offer reasonable assistance to the Party
bringing suit in connection therewith at no charge to the
38
Party bringing suit except for reimbursement of reasonable
out-of-pocket expenses incurred in rendering such assistance.
(3) In any suit brought by GI pursuant to this Section 22.2, GI shall
pay [***] and receive [***].
22.3 Claimed Infringement.
(1) Notice; Cooperation. In the event that a third party at any time
provides written notice of a claim to, or brings an action, suit
or proceeding against, any Party or any of their respective
Affiliates or sublicensees, claiming infringement of its patent
rights or copyrights or unauthorized use or misappropriation of
its Confidential Information, based upon an assertion or claim
arising out of the manufacture, use and/or sale of Products, such
Party shall promptly notify the other Parties of the claim or the
commencement of such action, suit or proceeding, enclosing a copy
of the claim and/or all papers served. Each Party agrees to make
available to the other Parties its advice and counsel regarding
the technical merits of any such claim at no cost to the other
Party.
23. Confidential Information.
23.1 Nondisclosure of Confidential Information. Neither Party may directly
or indirectly publish, disseminate or otherwise disclose, deliver or
make available to any person outside its organization any of the other
Parties' Confidential Information. Each Party may disclose the other
Parties' Confidential Information to persons within its organization
and to its Affiliates and sublicensees who/which have a need to
receive such Confidential Information in order to further the purposes
of this Agreement and who/which are bound to protect the
confidentiality of such Confidential Information. Each Party may
disclose the other Parties' Confidential Information to a governmental
authority or by order of a court of competent jurisdiction, provided
that such disclosure is subject to all applicable governmental or
judicial protection available for like material and reasonable advance
notice is given to the other Party.
23.2 Use of Confidential Information. Each Party shall use the other
Parties' Confidential Information solely for the purposes contemplated
in this Agreement or for such other purposes as may be agreed upon by
the Party in writing.
23.3 Agreements with Personnel and Third Parties. The Parties have or shall
obtain agreements with all personnel and third parties who will have
access to the other
39
Parties' Confidential Information which impose comparable
confidentiality obligations as are set forth in this Agreement on such
personnel and third parties.
23.4 Publications.
(1) Any Party may publish any manuscripts or other scientific papers
on work conducted exclusively by that Party under the Product
Collaboration without the written consent of the other Party.
However, a Party may not publish (or permit a third party to
publish) any manuscript or other scientific paper that discloses
or uses any Confidential Information without first obtaining that
other Party's written consent.
(2) Prior to the publication or other public disclosure of any
manuscripts or other forms of disclosure describing the results
of its work hereunder, the publishing Party shall provide (a) the
data to be disclosed in that manuscript or other form of public
disclosure to the other Party as soon as practicable, but at
least four (4) weeks prior to intended submission for publication
or other method of public disclosure, (b) a copy of the draft
manuscript to be published, or a detailed summary of any other
public disclosure to the other Party as soon as practicable, but
at least two (2) weeks prior to intended submission for
publication or other method of public disclosure, (c) a copy of
the completed manuscript or other form of public disclosure at
the time of submission and (d) a copy of any reviewer's comments
on the manuscript or other form of public disclosure with a
revised copy thereof at least two (2) weeks prior to publication.
(3) A Party may request that the publishing Party delete from its
manuscripts or other scientific papers or other forms of public
disclosure reference to Confidential Information. In addition, if
a Party notifies another Party that it desires patent
applications to be filed on any information to be disclosed by
that other Party in a public forum other than in manuscripts or
other scientific papers, the presenting Party will defer such
presentation for a period, not to exceed thirty (30) additional
days, sufficient to permit the Party with rights to file any
desired patent applications to do so.
24. Product Liability Indemnification.
24.1 CAT Indemnification. CAT agrees to defend GI and its respective
Affiliates, sublicensees, agents, directors, officers, employees,
students and licensees of rights to a Licensed Product, as applicable
(the "indemnities") (other than in settlement of a claim of
infringement), at CAT' cost and expense, and will indemnify and hold
harmless such indemnities from and against any and all liabilities,
losses, costs, damages, fees, or expenses claimed by or paid to a
third party attributable to injury to
40
persons or damage to property ("Losses") arising out of or in
connection with the manufacture, use and/or sale of any Licensed
Producer by CAT, its Affiliates, or sublicensees (other than GI);
provided that such Losses do not arise out of the gross negligence or
willful misconduct of GI (with respect to CAT' obligations to the GI
indemnities under this Section).
24.2 GI Indemnification. GI agrees to defend CAT and its respective
Affiliates, permitted sublicensees, agents, directors, officers,
employees, students and licensees of rights to a Licensed Product, as
applicable (the "indemnitee")(other than in settlement of a claim of
infringement), at GI's cost and expense, and will indemnify and hold
harmless such indemnitee from and against any and all Losses arising
out of or in connection with the manufacture, use and/or sale of any
Licensed Product or Research Product by GI, its Affiliates, or
sublicensees (other than CAT); provided that such Losses do not arise
out of the gross negligence or willful misconduct of CAT (with respect
to GI's obligations to the CAT indemnitee under this Section).
24.3 Notice; Cooperation. In the event of any such indemnifiable claim, the
indemnified Party shall promptly notify the indemnifying Party in
writing of the claim and the indemnifying Party shall manage and
control, at its sole expense, the defense of the claim and its
settlement. The indemnified Party shall cooperate with the
indemnifying Party and may, at its option and expense, be represented
in any such action or proceeding. The indemnifying Party shall not be
liable for any settlements, litigation costs, or expenses incurred by
the indemnified Party without the indemnifying Party's written
consent, such consent to be promptly given and not unreasonably
withheld.
24.4 Liability Limitation. Neither GI nor CAT shall be liable for special,
incidental or consequential damages or for loss of profit or lost
revenue, even another party had been advised of the possibility of
such damages.
24.5 Insurance. Prior to initial human testing or first commercial sale of
any Licensed Product or Research Product in any particular country, GI
and CAT each shall either (a) secure and maintain at its own expense
during the term of this Agreement an insurance policy or policies with
an insurer or insurers acceptable to the other Parties or (b) self
insure at a level sufficient to protect the Parties against any and
all risks typically insured against by businesses comparable to the
Party, including without limitation general and products liability,
arising or occurring upon or in connection with each Party's business.
Such policy or policies shall include general and products liability
coverage in an amount typically secured by businesses comparable to
the Party. Each Party shall furnish the other Party with certificates
evidencing all such insurance. Each Party shall name the other Party
as additional insureds in such policy or policies.
41
25. Term and Termination of Agreement.
25.1 Term. This Agreement shall remain in effect until terminated in
accordance with the provisions of this Section 25 or until the last to
expire of any of the licenses granted pursuant to this Agreement.
25.2 Termination for Breach. Each Party shall be entitled to terminate this
Agreement by written notice to the other Parties in the event that any
other Party shall be in default of any of its material obligations
hereunder, and shall fail to remedy any such default within sixty (60)
days after notice thereof by the non-breaching Party. Any such notice
shall specifically state that the non'breaching Party intends to
terminate this Agreement in the event that the breaching Party shall
fail to remedy the default. Upon any termination of this Agreement
pursuant to this Section 25.2, none of the Parties shall be relieved
of any obligations incurred prior to such termination.
25.3 Termination of Contract Research Program by GI. Notwithstanding
anything herein to the contrary, GI shall, in its sole discretion,
have the right to terminate the Contract Research Program at any time
after the date one year following the Effective Date, by giving sixty
(60) days written notice to CAT, provided however that if in the first
year, CAT, pursuant to Section 16.1, rejects (a) [***] in the first
[***] of the Contract Research Program or (b) more than [***] of the
delivered Research Antigens, [***] GI shall have the right to promptly
terminate the Contract Research Program by giving thirty (30) days
notice to CAT.
25.4 Survival of Obligations; Return of Confidential Information.
Notwithstanding any termination of this Agreement, the obligations of
the Parties under Article 2, Article 4, Article 6, Section 15.3 and
Article 25, as well as under any other provisions which by their
nature are intended to survive any such termination, shall survive and
continue to be enforceable. Upon any termination of this Agreement
pursuant to Section 25.2. hereof, each Party shall promptly return to
the other Party all written Confidential Information, and all copies
thereof, of the other Party which is not covered by a license
surviving such termination.
26. Miscellaneous.
26.1 Publicity.
(1) General. No Party, nor any of its Affiliates, shall originate any
publicity, news release or other public announcement, written or
oral, relating to this Agreement without the prior written
approval of the other Party, which approval shall not be
unreasonably withheld, except as otherwise required by law. It is
expressly understood that nothing in this Section 26 shall
prevent a Party from making a disclosure in connection with any
required filings with
42
the Securities and Exchange Commission or the London Stock
Exchange or in connection with the offering of securities or any
financing.
(2) Initial Press Release. With respect to the press release set
forth in Exhibit G, CAT represents that all disclosures relating
to the actual and/or potential value of this Agreement to CAT
("Financial Disclosures") are accurate and necessary under the
securities laws to which CAT is subject.
26.2 Conduct of Studies. All studies, research and testing done by or on
behalf of each Party under this Agreement shall be performed in strict
compliance with any applicable federal, state, or local laws, rules,
and regulations governing the conduct of studies, research, and
testing at the site where such studies, research, and testing are
being conducted.
26.3 No Implied Licenses. Only the licenses granted pursuant to the express
terms of this Agreement shall be of any legal force and effect. No
license rights shall be created by implication or estoppel.
26.4 No Agency. Nothing herein shall be deemed to constitute any Party as
the agent or representative of the other Parties, or the Parties as
joint venturers or partners for any purpose. Each Party shall be an
independent contractor, not an employee or partner of the other
Parties, and the manner in which each Party renders its services under
this Agreement shall be within its sole discretion. No Party shall be
responsible for the acts or omissions of the other Parties, and no
Party will have authority to speak for, represent or obligate the
other Parties in any way without prior written authority from the
other Party or Parties.
26.5 Notice. All notices required under this Agreement to be given by one
Party to another shall be in writing and shall be given by addressing
the same to the other at the address or facsimile number set forth
below, or at such other addresses or facsimile numbers as the Parties
may specify in writing. All notices shall become effective when
deposited in the United States Mail with proper postage for first
class registered or certified mail prepaid, return receipt requested,
or when delivered personally, or, if promptly confirmed by mail as
provided above, when dispatched by facsimile.
GI: Genetics Institute, Inc.
▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telecopier (▇▇▇) ▇▇▇-▇▇▇▇
Attn: Legal Department
CAT: Cambridge Antibody Technology Limited
▇▇
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇
Telecopier: 1763263413
Attn: The Company Secretary
26.6 Assignment. This Agreement, and the rights and obligations hereunder, may
not be assigned or transferred, in whole or in part, by any Party without
the prior written consent of the other Party, except that (a) upon notice
to the other Party, GI may assign this Agreement to an Affiliate
controlled by GI, and following the first year of the Contract Research
Program, CAT may assign this Agreement to an Affiliate which is
controlled by CAT, provided that each such Party remains primarily liable
and/or responsible for the performance of such obligations and such
controlled Affiliate, and provided further that such controlled Affiliate
agrees to be bound to the terms and conditions of this Agreement and (b)
upon notice to the other Parties, GI may assign this Agreement in
connection with the merger, consolidation or sale of all or substantially
all of GI's assets.
26.7 Entire Agreement. This Agreement constitutes the entire agreement of the
Parties with regard to its subject matter, and supersedes all previous
written or oral representations, agreements and understandings between
the Parties.
26.8 Development/Commercialization of [***]. At such time as GI, in its sole
discretion, elects develop and commercialize a human pharmaceutical
antibody product which specifically targets [***], GI shall undertake
good faith discussions with CAT concerning possible joint development
and/or commercialization of such [***].
Nothing set forth in the immediately preceding sentence should be
construed to create an obligation on GI to (a) research or develop or
commercialize any [***] or (b) collaborate with or enter into any
agreement with CAT concerning any [***].
26.9 No Modification. This Agreement may be changed only by a writing signed
by the Parties.
26.10 Headings. The headings contained in this Agreement are for convenience of
reference only and shall not be considered in construing this Agreement.
26.11 Waiver. The waiver by any Party of a breach or a default of any provision
of this Agreement by another Party shall not be construed as a waiver of
any succeeding breach of the same or any other provision, nor shall any
delay or omission on the part of any Party to exercise or avail itself of
any right, power or privilege that it has or may have hereunder operate
as a waiver of any right, power, or privilege by such Party.
44
26.12 Severability. In the event that any one or more of the provisions
contained in this Agreement shall, for any reason, be held to be invalid,
illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provisions of this Agreement,
and all other provisions shall remain in full force and effect. If any of
the provisions of this Agreement is held to be excessively broad or
invalid, illegal or unenforceable in any jurisdiction, it shall be
reformed and construed by limiting and reducing it so as to be
enforceable to the maximum extent permitted by law in conformance with
its original intent. In the event that after such reformation, a party's
rights or obligations are materially changed, then such Party may
terminate this Agreement.
26.13 Successor and Assigns. This Agreement shall be binding upon and inure to
the benefit of the Parties hereto and their successors and permitted
assigns.
26.14 Counterparts. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.
26.15 Applicable Law. This Agreement shall in all events and for all purposes
be governed by, and construed in accordance with, the law of the State of
New York without regard to any choice of law principle that would dictate
the application of the law of another jurisdiction.
In the event a Party institutes litigation against the other Party, the
instigating Party (a) if GI, shall institute such litigation in London,
England and (b) if CAT, shall institute such litigation in Boston,
Massachusetts.
26.16 EC Notification. If the Parties decide to notify this Agreement to the
Commission of the European Community, pursuant to Council Regulation
17/62 of the Council of Ministers of the European Community, they shall
cooperate in preparing the notification documents. Each Party shall be
responsible for its own costs and expenses related to such notification.
Each Party will give the other full and prompt cooperation in providing
any necessary information the other may require in order to prepare such
notification.
45
IN WITNESS WHEREOF, duly-authorized representatives of the parties have
signed this Agreement as a document under seal as of the Effective Date.
GENETICS INSTITUTE, INC.
By
Print Name
Title
duly authorized
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
By
Print Name
Title
duly authorized
46
IN WITNESS WHEREOF, duly-authorized representatives of the parties have
signed this Agreement as a document under seal as of the Effective Date.
GENETICS INSTITUTE, INC.
By
Print Name
Title
duly authorized
CAMBRIDGE ANTIBODY TECHNOLOGY GROUP PLC
By
Print Name
Title
duly authorized
Final Draft - Research Collaboration and Service Agreement
47
EXHIBIT A
ACCEPTED ANTIGENS
[***]
EXHIBIT B
EXISTING THIRD PARTY OBLIGATIONS
(GI/MRC/DYAX SUBLICENSEE ROYALTIES)
1. License Agreement, dated January 7, 1997, between CAT and MRC, with certain
royalty rates, as may be amended from time to time (the "MRC License"). For
such royalty rate calculations, see Exhibit F for the applicable text of
the MRC License.
2. Therapeutic Antibodies Agreement, dated December 31, 1997, between CAT and
Dyax Corp., with a royalty rate of [***] as may be amended from time to
time (the "Dyax License").
3. Diagnostic Antibodies Agreement, dated December 31, 1997, between CAT and
Dyax Corp., with a royalty rate of [***] as may be amended from time to
time (the "Dyax License").
EXHIBIT C
ProAb Tissue
------------
[***]
It is agreed that, should any of the above tissue be unavailable, then CAT
may substitute another tissue, with the prior written approval of GI.
EXHIBIT D
Software
The Software is defined as Cat's CONTINUITY product. It is defined as all CAT
server and client software components and database schema that CAT supplies that
to GI, and to any and all object modules, executables and database schema
derived from these schema or the compilation of these software components. These
components and database schema are part of CONTINUITY and are designed to allow
submission of data in an appropriate format to CAT and mining and visualization
of data and information supplied to GI by CAT.
Hardware
SUN ULTRA 10 workstation, 256 MB RAM for running CONTINUITY Object Transaction
Monitoring (OTM) framework.
Specifications
CONTINUITY is 100% Java. Server OTM framework supported under SUN Solaris 7.
CONTINUITY client software is supported under MS Windows 95/98/NT, MacOS 8.1 and
later, Sun ▇▇▇▇▇▇▇ ▇, ▇▇▇ Irix 6.2 and later. Backend database requirements
Oracle 8. CONTINUITY clients runs on machines with a minimum of 64 MB RAM.
Supported browsers, Netscape 4.05 and later (recommended Netscape 4.5) -
Netscape as opposed to IE required because of cross-platform support
requirements. CONTINUITY requires a Visibroker CORBA naming service.
EXHIBIT E
ANTIBODY ENGINEERING SERVICES
In the event GI requests AB Engineering Services pursuant to Section 21.1
hereof, GI shall pay to CAT the amount set forth in one of the following
options:
Option 1
--------
(a) [***] per year, payable quarterly and (b) engineering performance
success payment in an amount equal to [***] payable following achievement
of the antibody engineering performance criteria agreed upon by the
parties prior to the commencement of Ab Engineering Services or
Option 2
--------
(a) [***] per year, payable quarterly and (b) engineering performance
success payment in an amount equal to [***] payable following achievement
of the antibody engineering performance criteria agreed upon by the
parties prior to the commencement of Ab Engineering Services.
EXHIBIT F
7. FEES AND ROYALTIES
7.1 CAT shall pay MRC in consideration of the grant made in this Agreement the
following sums (exclusive of VAT thereon);
7.1.1.
7.1.2. Subject always to the provisions of Clause 7.2 a Royalty of [***]
of the Net Invoice Price on each sale of the Products by CAT or its
Affiliates;
7.1.3 Subject always to the provisions of Clause 7.2 a Royalty calculated
in respect of the Net Invoice Price ("NIP") of each sale of the
Products by CAT's sub-licensees, such Royalty to be calculated as
follows:-
(a) MRC to receive from [***] of the royalty percentage
calculated by reference to NIP payable to CAT by any sub-
licensee up to a maximum of [***] of the NIP of CAT's sub-
licensee's sale of Products provided always that MRC shall
not on any occasion receive payments which represent less
than [***] of the NIP of CAT's sub-licensees sale of
Products; and
(b) MRC to receive from CAT [***] of any additional royalty
percentage calculated by reference to NIP payable to CAT by
any sub-licensee in excess of [***] and up to [***] of the
NIP of CAT's sub-licensee's sale of Products.
7.2 There are 2 circumstances in which there will be a reduction to the
royalties payable by CAT under Clauses 7.1.2 and 7.1.3 as follows:
7.2.1 If CAT or its sub-licensees are required to licence any third party
dominating patents in order to be able to exercise the rights
granted to it hereunder involving use of the inventions disclosed
in the patents and the corresponding patents listed in Schedule 1
as number [***] and number [***] and numbers [***] and [***] CAT
may deduct from the sums due to MRC all such sums payable to such
third parties up to a maximum of [***] of the sums due to MRC
provided that such a reduction shall not be made where a reduction
has already been or is to be made under Clause 7.5 below.
7.2.2 Where Products infringe only those of the Patent rights which deal
with [***] being those patents referred to in Schedule 1 as numbers
[***] royalties shall be payable at [***] of the normal rate.
7.5 Royalties on Products paid by CAT to MRC under prior existing agreements
between MRC and CAT shall be creditable against a maximum of [***] on
Royalties payable on the same Products by CAT under clauses 7.1.2 and
7.1.3.
EXHIBIT G
PRESS RELEASE
FOR IMMEDIATE RELEASE
07.30 a.m. Tuesday 30 March 1999
CAMBRIDGE ANTIBODY TECHNOLOGY & WYETH-AYERST
LABORATORIES FORM MAJOR ALLIANCE
Wyeth-Ayerst signs broad deal to harness CAT's technologies
for target validation and therapeutic product development
Melbourn, UK and Cambridge, Mass...Cambridge Antibody Technology Group plc
("AT") (LSE : CAT"), and the research division of Wyeth-Ayerst Laboratories -
Wyeth Ayerst Research (NYSE : AHP), today announced that they have entered into
an agreement for the broad application of CAT's function genomics and antibody
engineering expertise the discovery and development of new therapeutics based on
targets identified by Wyeth Ayerst.
Summing up the alliance ▇▇. ▇▇▇▇▇▇ ▇. ▇▇▇▇▇, Senior Vice President, Discovery
Research, Eyther-Ayest Research commented:
"CAT has developed powerful technologies both to enhance and accelerate the
selection of drug targets ad to develop fully human antibody therapeutics.
This agreement will help Wyeth-Ayerst more efficiently mine the wealth of
information generated by our research programmes and expand our portfolio
of antibody therapeutics."
▇▇. ▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Chief Executive Officer of CAT, said:
"The alliance with Wyeth-Ayerst, a world leader in biopharmaceutical
research provides CAT with outstanding potential targets and complementary
target validation technologies to help fuel our antibody product pipeline
as well as generating near-term revenue. It is a major endorsement of the
capabilities we have established in functional genomics over the past two
years, and of our antibody engineering expertise."
The agreement with Wyeth-Ayerst comprises a research collaboration, a product
collaboration and a library licence option.
Under the terms of the research collaboration, Wyeth-Ayerst has agreed to pay
CAT $4 million per annum in research funding for up to four years, for CAT to
apply its proprietary PROAB(R) and ProxiMol(R) functional genomics technologies
to potential protein targets based on gene
sequence information provided by Wyeth, together with other research work. In
conjunction with this collaboration, CAT will establish its bioinformatics
software CONTINUITY(TM), at Wyeth's research facilities in the U.S., to
facilitate Wyeth's access to the large amounts of data supplied by CAT. Wyeth-
Ayerst has options to develop antibody products derived from the research
collaboration. Cat receives license fees, clinical milestone fees and royalties
in respect of these products.
Under the product collaboration, Wyeth-Ayerst and CAT will validate and develop
product candidates directed at novel proprietary Wyeth targets as well as
targets contributed by CAT, with the goal of developing a broad portfolio of
human antibody-based drug candidates. Each company has the opportunity to select
candidates for further development from this pool. The companies will share
equally the target and product validation costs. For those product candidates
developed by Wyeth, CAT will receive license fees, clinical milestone fees and
royalties. For those products developed by CAT, Wyeth-Ayerst will receive
license fees, clinical milestone fees and royalties and limited rights to
partner the programme after Phase II clinical trials.
CAT has also granted Wyeth-Ayerst multi-site options to license CAT's phage
library technology with associated product development options.
The total of research funding, potential library licence fees and potential fees
and milestones from the product collaboration is approximately $70 million. In
addition there are potential fees and milestones on product development options
under the research collaboration and library licence option.
- ENDS -