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EXHIBIT 10.35
RESEARCH COLLABORATION AGREEMENT
[*]
THIS RESEARCH COLLABORATION AGREEMENT dated as of September 29, 1998
(this "Agreement"), is entered into between ABGENIX, INC., a Delaware
corporation ("Abgenix"), having a place of business at 0000 Xxxxxxxxx Xxxxxx,
Xxxxxxx, Xxxxxxxxxx 00000, and MILLENNIUM BIOTHERAPEUTICS, INC., a Delaware
corporation ("MBio"), having a place of business at 000 Xxxxxxxx Xxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000, with respect to the following facts:
WHEREAS, Abgenix and MBio are interested in negotiating a research
license and option agreement (the "Research License and Option Agreement")
regarding the generation of human monoclonal antibodies to [*] (the "Antigen")
where the antibodies to the Antigen are generated through the use of certain
Abgenix technology; and
WHEREAS, in connection with, and during the conduct of, such
negotiations, the parties desire to conduct a research program pursuant to which
(a) MBio will immunize, with the Antigen, certain of Abgenix's transgenic mice
which are capable of producing human antibodies when immunized with antigen (the
"XenoMouse(TM) Animals") provided by Abgenix to MBio and will generate
antibodies therefrom, (b) MBio will conduct certain analyses and
characterizations of such antibodies, and (c) the parties will review and
analyze the data and results of such research activities.
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual covenants herein contained, the parties hereby agree as follows:
1. Definitions. For purposes of this Agreement, the terms defined in
this Section 1 shall have the respective meanings set forth below:
"Abgenix Materials" shall mean, collectively, (a) the
XenoMouse Animals and other materials specified in Exhibit A hereto, as well as
any derivatives, progeny, modifications or improvements thereto developed,
created, synthesized or designed therefrom, and any genetic material
therefrom;and (b) any XenoMouse Animals immunized with the Antigen; provided,
however, the Abgenix materials shall not include Research Materials and
Inventions.
"Confidential Information" shall mean, with respect to a
party, all information of any kind whatsoever (including without limitation,
compilations, data, formulae, models, patent disclosures, procedures, processes,
projections, protocols, results of experimentation and testing, specifications,
strategies and techniques), and all tangible and intangible embodiments thereof
of any kind whatsoever (including without limitation, apparatus, biological or
chemical materials, animals, cells, compositions, documents, drawings,
machinery, patent applications, records, reports), which is owned or controlled
by such party and is disclosed by such party to the receiving party and is
marked, identified as or otherwise acknowledged to be confidential at the time
of disclosure to the receiving party. Notwithstanding the foregoing,
Confidential Information of a party shall not include information which the
receiving party can establish by written documenta-
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tion (a) to have been publicly known prior to disclosure of such information by
the disclosing party to the receiving party, (b) to have become publicly known,
without fault on the part of the receiving party, subsequent to disclosure of
such information by the disclosing party to the receiving party, (c) to have
been received by the receiving party at any time from a source, other than the
disclosing party, rightfully having possession of and the right to disclose such
information free of confidentiality obligations, (d) to have been otherwise
known by the receiving party free of confidentiality obligations prior to
disclosure of such information by the disclosing party to the receiving party,
or (e) to have been independently developed by employees or agents of the
receiving party without access to or use of such information disclosed by the
disclosing party to the receiving party. The parties acknowledge that the
foregoing exceptions shall be narrowly construed and that the obligations
imposed upon each party under Section 6 below shall be relieved solely with
respect to such Confidential Information of the disclosing party which falls
within the above exceptions and not with respect to related portions, other
combinations, or characteristics of the Confidential Information of the
disclosing party including, without limitation, advantages, operability,
specific purposes, uses and the like.
"Materials" shall mean, collectively, the Abgenix Materials
and the Research Materials and Inventions.
"Research" shall mean the interim research program described
in Exhibit B hereto.
"Research Materials and Inventions" shall mean [*] which
results from the performance of the Research by MBio.
"Xenotech" shall mean Xenotech L.P., a California limited
partnership.
2. Research.
a. Abgenix shall transfer to MBio the XenoMouse Animals and
other materials specified in Exhibit A hereto for the sole purpose of performing
the Research. MBio shall use the Abgenix Materials for the sole purpose of
performing the Research, at its address listed above, under commercially and
scientifically reasonable containment conditions, and not for any commercial,
business or other use or purpose without the prior express written consent of
Abgenix. MBio shall not transfer or provide access to the Abgenix Materials
transferred to it by Abgenix hereunder to any other person or entity or to any
location other than its address set forth above,
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without the prior express written consent of Abgenix (which consent may be
conditioned inter alia upon such person or entity duly executing and delivering
Abgenix's standard form of material transfer agreement therefor); provided,
however, that MBio shall have the right to transfer the Research Materials and
Inventions to Abgenix. MBio shall limit access to the Abgenix Materials to those
of its employees working on its premises, to the extent such access is
reasonably necessary in connection with its activities as expressly authorized
by this Agreement.
b. MBio shall conduct the Research under the direct
supervision of [*], who shall be the primary contact for MBio regarding the
Research. [*]
3. Further Restrictions on Use and Control over the XenoMouse Animals.
Abgenix is willing to transfer the XenoMouse Animals to MBio solely on the terms
and conditions contained in this Agreement. The XenoMouse Animals contain
technology and intellectual property which has been licensed to Abgenix under
specific terms and conditions set forth in certain licensing agreements with
third parties, including without limitation Xenotech. The transfer of the
XenoMouse Animals and the use of XenoMouse Animals by MBio is made expressly
subject to the following terms and conditions:
a. all XenoMouse Animals transferred to MBio shall be the sole
property of Abgenix, and the transfer of physical possession to MBio, and/or
possession or use by MBio of XenoMouse Animals shall not be, nor be construed
as, a sale, lease, offer to sell or lease, or other transfer of title to or any
interest in any XenoMouse Animals;
b. all XenoMouse Animals shall remain in the control of MBio,
and MBio shall not (and shall not attempt or purport to) transfer the XenoMouse
Animals to any third party, without the prior express written consent of Abgenix
(which may be conditioned inter alia upon such third party duly executing and
delivering Abgenix's standard form of material transfer agreement therefor);
c. MBio shall not directly or indirectly use or attempt to use
the XenoMouse Animals or any derivatives, information or biological or chemical
materials derived from, based upon or related thereto to reproduce, generate,
create or produce, through breeding, reverse-engineering, genetic manipulation
or otherwise, the XenoMouse Animals or other transgenic mice or other transgenic
animals;
d. the XenoMouse Animals shall be delivered to MBio solely for
the purpose of immunizing the XenoMouse Animals with the Antigen as specified in
Exhibit B, and MBio shall not use the XenoMouse Animals for any purpose other
than immunizing the XenoMouse Animals with the Antigen and subsequent use of
such immunized XenoMouse Animals as reasonably necessary solely for purposes of
conducting the Research;
e. MBio shall not (and shall not attempt or purport to)
transfer, assign, sell, have sold, lease, offer to sell or lease, otherwise
transfer title to, or otherwise distribute or license, sublicense or otherwise
commercialize or exploit, any XenoMouse Animals or any interest in any XenoMouse
Animals;
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f. MBio shall not directly or indirectly use the XenoMouse
Animals to make or use antibodies to [*];
g. Other than Research Materials and Inventions as defined in
Section 1 and as provided in Section 7(b) of this Agreement, Abgenix shall own
all right, title and interest in and to all discoveries, inventions, materials,
products, derivatives, know-how and information (whether or not patentable),
together with all patent rights and other intellectual property rights therein,
which are conceived, made, created or developed by MBio (and any of its agents
or employees) through any use of the XenoMouse Animals which is not in
accordance with the terms and conditions set forth in this Agreement; and
h. Xenotech shall be a third-party beneficiary of the
obligations and commitments by MBio set forth in items (a) through (f) above.
4. Reports. MBio shall keep Abgenix informed of all uses made of the
Abgenix Materials provided to it. MBio shall provide Abgenix [*].
5. Publication. Unless otherwise agreed to in writing by Abgenix or
otherwise provided in Section 6 below, neither party shall have the right to
disclose to third parties, or to otherwise publish, the Research Materials and
Inventions, the reports described in Section 4 above (or any data or information
contained therein), or the source data and information described in Section 4
above.
6. Confidentiality.
a. During the term of this Agreement and for a period of five
(5) years following the expiration or earlier termination hereof, each party
shall maintain in confidence the Confidential Information of the other party,
and shall not disclose, use or grant the use of the Confidential Information of
the other party except on a need-to-know basis to such party's directors,
officers and employees, and to such party's consultants working on such party's
premises, to the extent such disclosure is reasonably necessary in connection
with such party's activities as expressly authorized by this Agreement. To the
extent that disclosure to any person is authorized by this Agreement, prior to
disclosure, a party shall obtain written agreement of such person to hold in
confidence and not disclose, use or grant the use of the Confidential
Information of the other party except as expressly permitted under this
Agreement. Each party shall notify the other party promptly upon discovery of
any unauthorized use or disclosure of the other party's Confidential
Information. Upon the expiration or earlier termination of this Agreement, each
party shall return to the other party all tangible items regarding the
Confidential Information of the other party and all copies thereof; provided,
however, that each party shall have the right to retain one (1) copy for its
legal files for the sole purpose of determining its obligations hereunder.
b. Notwithstanding anything to the contrary in this Agreement,
for purposes of this Agreement, the Abgenix Materials and all oral or written
communications received by MBio regarding the Abgenix Materials are, and shall
remain, Confidential Information of [*].
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c. Notwithstanding anything to the contrary in this Agreement,
for purposes of this Agreement, the Research Materials and Inventions and all
oral or written communications received by MBio regarding the Research Materials
and Inventions are, and shall remain, Confidential Information of [*].
d. Neither party shall disclose any terms or conditions of
this Agreement to any third party without the prior consent of the other party;
provided, however, that a party may disclose the terms or conditions of this
Agreement, (i) on a need-to-know basis to its affiliated companies including,
but not limited to, for MBio, Millennium Pharmaceuticals, Inc., Millennium
Information, Inc., Millennium Predictive Medicine, Inc., plus any future
affiliated companies that own a majority of the stock of MBio or that MBio owns
a majority of the stock thereof and for Abgenix, Xenotech L.P. plus any future
affiliated companies that own a majority of the stock of Abgenix or that Abgenix
owns a majority of the stock thereof) and to its/their legal and financial
advisors to the extent such disclosure is reasonably necessary in connection
with such party's activities as expressly permitted by this Agreement, (ii) to a
third party in connection with (A) an equity investment in such party by a third
party, (B) a merger, consolidation or similar transaction entered into by such
party, or (C) the sale of all or substantially all of the assets of such party,
and (iii) as may, in the reasonable opinion of such party's counsel, be required
by applicable law, regulation or court order, including without limitation, a
disclosure in connection with such party's filing of a registration statement or
other filing with the United States Securities and Exchange Commission (in which
event such party will first consult with the other party with respect to such
disclosure). Notwithstanding the foregoing, prior to execution of this Agreement
Abgenix and MBio shall agree upon the substance of information that can be used
to describe the terms of this transaction, and each party may disclose such
information, as modified by written agreement of Abgenix and MBio from time to
time, without the consent of the other.
e. The confidentiality obligations under this Section 6 shall
not apply to the extent that a party is required to disclose Confidential
Information of the other party by applicable law, regulation or order of a
governmental agency or a court of competent jurisdiction; provided, however,
that such party shall provide written notice thereof to the other party and
sufficient opportunity to object to any such disclosure or to request
confidential treatment thereof.
7. Ownership and Control of Materials.
a. All right, title and interest to the Abgenix Materials and
all patent rights and other intellectual property rights therein shall belong
[*]. MBio shall not (and shall not attempt or purport to) transfer, assign,
sell, have sold, lease, offer to sell or lease, otherwise transfer title to, or
otherwise distribute or license, sublicense or otherwise commercialize or
exploit, any Abgenix Materials, unless Abgenix otherwise expressly agrees in
writing. Promptly upon the earlier of (i) completion of the Research or (ii) the
expiration or termination of this Agreement, MBio shall destroy or return to
Abgenix all remaining Abgenix Materials (as Abgenix shall direct), unless
Abgenix otherwise expressly agrees in writing prior to such completion,
expiration or termination. MBio shall not (and shall not attempt or purport to)
file or prosecute in any country any patent application which claims or purports
to claim the Abgenix Materials or any use thereof, without the prior express
written consent of Abgenix.
b. Unless the parties otherwise expressly agree in writing,
all right, title and interest to all the Research Materials and Inventions and
all patent rights and other intellectual
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property rights therein shall belong [*]. MBio shall use the Research Materials
and Inventions, at is address listed above, for the sole purposes of performing
the Research, [*]. Neither party shall transfer or provide access to the
Research Materials and Inventions to any third party or to any location other
than its address set forth above, without the prior express written consent of
the other party. Neither party shall (and neither party shall attempt or purport
to) transfer, assign, sell, have sold, lease, offer to sell or lease, otherwise
transfer title to, or otherwise distribute or license, sublicense or otherwise
commercialize or exploit, any Research Materials and Inventions (or any products
derived thereof), unless the other party otherwise expressly agrees in writing.
Promptly upon the expiration or earlier termination of the term of this
Agreement, each party shall destroy all remaining Research Materials and
Inventions, unless the parties otherwise expressly agree in writing prior to
such expiration or termination. Neither party shall (and neither party shall
attempt or purport to) file or prosecute in any country any patent application
which claims or purports to claim the Research Materials and Inventions or any
use thereof unless and until the parties duly execute and deliver the Research
License and Option Agreement in accordance with Section 12 below, without the
prior express written consent of the other party.
8. No Warranty. The Materials are being provided for research purposes
only solely to facilitate the Research. THE MATERIALS ARE BEING SUPPLIED "AS
IS," WITH NO WARRANTIES, EXPRESS OR IMPLIED, AND ABGENIX EXPRESSLY DISCLAIMS ANY
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
NONINFRINGEMENT.
9. Care in Use of the Materials. The parties acknowledge that the
Materials are experimental in nature and may have unknown characteristics. Each
party agrees to use prudence and reasonable care in the use, handling, storage,
transportation, disposition, and containment of the Materials provided by the
other party. MBio shall not administer the Materials to humans, or file or
submit any regulatory application or other submission to obtain approval
therefor, under any circumstances.
10. Indemnification. MBio shall indemnify and hold harmless Abgenix
from and against all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) resulting from any claims, demands,
actions or other proceedings by any third party arising from (i) the material
breach of any representation, warranty or covenant by MBio under this Agreement,
(ii) the performance of the Research by MBio, (iii) any use, handling or storage
by MBio of the Abgenix Materials, (iv) any use, handling or storage by MBio of
the Research Materials and Inventions, or (v) any use by MBio of the
Confidential Information of Abgenix. Abgenix shall indemnify and hold harmless
MBio from and against all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) resulting from any claims, demands,
actions or other proceedings by any third party arising from any use by Abgenix
of the Confidential Information of MBio.
11. Compliance with Laws. MBio shall use the Materials in compliance
with all applicable laws, guidelines and regulations which are applicable to the
Materials or the use thereof, including without limitation any biosafety
procedures and all safety precautions accompanying the Materials.
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12. Negotiation of Research License and Option Agreement.
a. During the term of this Agreement, the parties shall
negotiate in good faith, and attempt to reach mutual agreement upon and enter
into, the Research License and Option Agreement. The Research License and Option
Agreement, if entered into between the parties, shall include the terms set
forth on Exhibit C and shall include such other terms and conditions as the
parties mutually agree, including, but not limited to, provisions relating to
intellectual property, confidentiality, publication, representations and
warranties of each party, diligence, indemnification and reporting. During the
term of this Agreement, Abgenix will not engage in negotiations with any third
party, or enter into any agreements with any third party, regarding a
collaboration, license or commercialization of human monoclonal antibodies,
generated through the use of the XenoMouse technology, to Antigen.
b. The obligations of Abgenix relating to the negotiations
described above or the Research License and Option Agreement are limited to the
extent that Abgenix has, and hereafter will have, the right to grant licenses
and other rights to the XenoMouse Animals and related technology. However,
Abgenix represents and warrants to MBio that it has no present knowledge of any
reason that it does not have the right to grant licenses and other rights to the
XenoMouse Animals to MBio, consistent with the terms and conditions of this
Agreement and the terms contemplated under Exhibit C hereto.
13. No Conflict. Each party represents that this Agreement does not,
and during the term of this Agreement will not, conflict with any other right or
obligation provided under any other agreement or obligation that such party has
with any third party.
14. Term of Agreement. This Agreement shall remain in effect for sixty
(60) days from the date of this Agreement, or such other date as the parties
mutually agree upon in writing. Upon the expiration of this Agreement, Sections
2(a) (other than the first sentence thereof), 3, 5, 6, 7 and 10 shall survive.
15. Assignment. MBio shall not assign its rights or obligations under
this Agreement, in whole or in part, by operation of law or otherwise, without
the prior express written consent of the Abgenix; provided, however, that MBio
may, without such consent, assign this Agreement and its rights and obligations
hereunder in connection with the transfer or sale of all or substantially all of
its business, or in the event of its merger or consolidation or change in
control or similar transaction. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. Any purported assignment in
violation of this Section 15 shall be void.
16. Waivers and Amendments. No change, modification, extension,
termination or waiver of this Agreement, or any of the provisions herein
contained, shall be valid unless made in writing and signed by duly authorized
representatives of the parties.
17. General. This Agreement contains the entire agreement between the
parties regarding the subject matter of this Agreement and supersedes any
previous understandings, representations, acknowledgements, commitments or
agreements, oral or written, regarding such subject matter. This Agreement shall
be governed by and construed under laws of the State of California, without
regard to its conflicts of laws principles.
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IN WITNESS THEREOF, the parties have caused this Agreement to be duly
executed and delivered as of the date first set forth above.
ABGENIX, INC. MILLENNIUM BIOTHERAPEUTICS, INC.
By: /s/ Xxxxxxx X. Xxxxx By: /s/ Xxxx Xxxxxxxxxx
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(Signature) (Signature)
Xxxxxxx X. Xxxxx, Ph.D. Xxxx Xxxxxxxxxx, Ph.D.
Vice President, Vice President,
Corporate Development General Manager
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Exhibit A
Abgenix Materials
[*]
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Exhibit B
Research Program
[*]
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Exhibit C
Key Terms of the Research License and Option Agreement
I. Option to Obtain a Product License
MBio would have the right to acquire an exclusive option (the "Option")
to enter into an exclusive license to develop and commercialize
licensed products pursuant to a license agreement (the "Product License
Agreement"), in the form of Abgenix's standard form of product license
agreement. MBio would have the right to acquire the Option on or before
July 31, 1999, by giving express written notice to Abgenix thereof and
paying to Abgenix the [*].
II. Product License Agreement
If MBio timely acquires the Option, MBio would have the right to
exercise the Option on or before February 28, 2000. MBio would have the
right to exercise the Option by executing the Product License Agreement
and paying to Abgenix [*]. MBio would not have the right to file an IND
with the FDA in the United States (or its equivalent with the governing
health authority of any country) for a licensed product, or to
otherwise commence human clinical trials of a licensed product, unless
and until MBio has exercised such option.
III. Development Milestones
[*]
IV. Royalties on Worldwide Net Sales
SCENARIO A: [*]
(i) MBIO would pay to Abgenix [*]
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[*]
(ii) MBIO would pay to Abgenix [*]
[*]
[*]
In both (i) and (ii) above, [*]
SCENARIO B: [*]
In the event MBio [*]
MBio would pay to Abgenix [*]
V. [*]
[*]
VI. Other: Terms and Conditions
The Research License and Option Agreement, if entered into between the
parties, shall include the terms set forth on this Exhibit C and shall
include such other terms and conditions as the parties mutually agree,
including, but not limited to, provisions relating to intellectual
property, confidentiality, publication, representations and warranties
of each party, diligence, indemnification and reporting.
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