SECTION A
THIS AGREEMENT (the "Agreement") is made this 22nd day of December 1999 (the
"Effective Date") by and between GENZYME TRANSGENICS CORPORATION ("GTC"), with
offices at 000 Xxxxxxxx Xxxxxxxxx, Xxxxxxxxxx, Xxxxxxxxxxxxx 00000-0000 X.X.X.
and Alexion Pharmaceuticals Inc. ("Alexion") located at 00 Xxxxxxx Xxxx, Xxx
Xxxxx, Xxxxxxxxxxx 00000.
1. BACKGROUND. Alexion is a biopharmaceutical company actively involved in
the development of [***] (the "Product"). Alexion is interested in GTC
producing Product in the milk of transgenic goats (the "Project"). GTC is
willing to perform the Project, subject to the terms and conditions of this
Agreement, including the Project Work Plan set forth herein.
2. EXPRESSION TECHNOLOGY. "Expression Technology" means GTC's proprietary
technology, which GTC shall use to generate and propagate transgenic animal
founder lines for Product.
3. PERFORMANCE OF THE PROJECT. The Project will be performed by GTC in
accordance with the Project Work Plan, which may be amended from time to time by
written agreement of the parties.
GTC shall conduct the Project in conformance with the Good Laboratory Practice
requirements of the United States Food and Drug Administration ("FDA") and
otherwise in compliance with all laws, ordinances, and governmental rules or
regulations pertaining thereto.
GTC will have met the success criteria of the Project and the Project will be
concluded upon demonstration that founder females produce in the ordinary course
milk containing fully processed, functional Product and delivery of reasonable
quantities of samples to Alexion, provided that GTC uses commercially reasonable
and diligent efforts to achieve such criteria within the timeline as hereinafter
provided. GTC makes no guarantee that such success criteria can be attained.
4. RECORDS.
4.1 GTC will keep accurate records of the status and progress of the
Project. GTC will not destroy such records without giving Alexion
prior written notice and the opportunity to further store such
records.
4.2 Alexion's personnel shall have the right to review such records
at GTC's facilities during regular business hours on 5 days'
written notice.
5. REPORTS.
5.1 PROJECT UPDATES. GTC will keep Alexion advised of the status of
the Project through regular telephone conversations and meetings.
5.2 FINAL REPORT. GTC will complete a final report of the Project
within sixty (60) days of its completion. If performance of the
Project is suspended or terminated prior to completion, GTC will
promptly provide Alexion with a final report of the results of
the Project through the date of suspension or termination.
Alexion is and shall at all times remain the sole owner of the
reports prepared by GTC.
6. COMPENSATION. Alexion agrees to pay GTC for the Project as
follows:
6.1 Alexion will pay GTC a Start-up fee of [***], payable on
execution of this Agreement by both parties;
6.2 Alexion will pay GTC a fee of [***] upon completion of the
microinjection of a suitable number of goat embryos which would
normally be expected to yield [***], and transfer of such
embryos to recipient females;
6.3 Alexion will pay GTC a fee of [***] upon the birth of the
first F0 goat transgenic for Product;
6.4 Alexion will pay GTC a success fee for expression of Product as
follows:
a. [***]
b. [***]
For avoidance of doubt, Alexion will only pay a maximum amount
equal to [***] for the successful expression of Product.
c. In the event GTC is not successful in obtaining either a
male or female founder animal with induced and/or natural
expression of approximately [***], as per (a)
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and (b) above, and the DNA provided by Alexion is
verified correct, GTC will conduct a second round of
microinjections [***].
6.5 Alexion will pay GTC a fee of [***] upon delivery of an amount
of clarified intermediate product which yields at least
[***] of pre-pivotal clinical grade Product, as
produced by a development scale purification process consistent
with industry standards, for comparability testing.
6.6 Should Alexion at its sole discretion elect to enter into a
Clinical Development and/or Commercial Supply Agreement pursuant
to Section 10.4 below, Alexion will pay GTC a commercial fee of
[***].
6.7 Alexion will pay GTC a fee in the amount of [***] in the
event that Alexion decides these activities are required.
6.8 Alexion will reimburse GTC for costs incurred as a result of
GTC's assistance with Alexion's collaboration with a third-party
to develop and scale-up a downstream purification process for
Product, [***].
Fully Burdened Costs means GTC's direct labor and materials
costs, plus allocable indirect overhead expenses and allocable
selling, general and administrative expenses, determined in
accordance with generally accepted accounting principles,
consistently applied.
6.9 Except for under the conditions set forth in Section 6.4(c),
Alexion also agrees to pay for transgenic animal maintenance
costs at [***] GTC's FBC during any period of delay in
the Project where GTC is not funded by Alexion to conduct
activities on the Project, until such time as the Project is
terminated, provided that such delay is not caused by the acts or
omissions of GTC. A minimum of thirty (30) days termination
notice applies to these costs.
7. CONFIDENTIALITY.
7.1 For a period of [***] years from the termination of this
Agreement, any Confidential Information (as defined below)
disclosed by the disclosing party hereunder, directly or
indirectly, to the receiving party hereunder, shall be deemed
confidential, and shall not be disclosed by the receiving party
to third parties, except as set forth below. Access to such
Confidential Information will be limited to employees, agents,
Affiliates (as defined
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below), consultants or contractors of the receiving party who
reasonably require such Confidential Information and who are
bound to the receiving party by similar obligations in respect of
confidentiality and use. The receiving party will use such
Confidential Information only to carry out its obligations or to
exercise its rights hereunder and will not use such Confidential
Information for its own benefit or for the benefit of others or
in any way inconsistent with this Agreement.
7.2 Nothing contained herein will in any way restrict or impair each
party's right to use, disclose or otherwise deal with any
Confidential Information which:
i) at the time of disclosure, is in the public knowledge;
ii) after disclosure, becomes part of the public knowledge by
publication or otherwise, except by breach of this Agreement by
the receiving party;
iii) was demonstrably in the receiving party's possession at the
time of such disclosure, and which was not acquired, directly or
indirectly, from the disclosing party;
iv) the receiving party receives from third parties, provided
such Confidential Information was not obtained by such third
parties, directly or indirectly, from the disclosing party on a
confidential basis;
v) results from research and development of the receiving party
demonstrably independent of such disclosure;
vi) is required to be disclosed by legal process; provided,
however, in each case the party so disclosing Confidential
Information timely informs the other party and uses its
reasonable efforts to limit the disclosure and maintain
confidentiality to the extent possible and permits the other
party to attempt by appropriate legal means to limit such
disclosure; and
vii) the disclosing party identifies in writing as being for
public disclosure.
7.3 For purposes of this Agreement, the term "Confidential
Information" shall mean all of the data, information, technology,
samples, DNA, specimens, materials and any other information
affecting the business operations of the disclosing party
received by the receiving party from the disclosing party
hereunder.
7.4 For purposes of this Agreement, the term "Affiliate" shall mean
any corporation which controls, is controlled by or is under
common control with a party hereto. A corporation shall be
regarded as in control of another corporation if it owns or
directly
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or indirectly controls at least fifty percent (50%) of the voting
stock of the other corporation, or in the absence of the
ownership of at least fifty percent (50%) of the voting stock, if
it possesses, directly or indirectly, the power to direct or
cause the direction of the management and policies of the
corporation.
7.5 In addition, neither party shall originate any written publicity,
news release or other public announcement or statement relating
to this Agreement or to the performance hereunder or the
existence of an arrangement between the parties without prior
review and written approval of the other party. Notwithstanding
the foregoing, either party may make a public written disclosure
if required by applicable law provided that prior to making such
written disclosure, the disclosing party shall provide the other
party with a copy of, and reasonable opportunity to review, the
materials to be disclosed. To the extent that the non-disclosing
party requests that any information in the proposed disclosure be
deleted, the disclosing party shall request confidential
treatment of such information pursuant to applicable law, so that
there be omitted from the materials that are publicly filed any
information that the non-disclosing party requests to be deleted.
8. RIGHTS AND DEVELOPMENTS.
8.1 DEFINITION. "Rights and Developments" include, without
limitation, ideas, concepts, discoveries, inventions,
developments, know-how, patent rights, trade secrets, techniques,
methodologies, innovations, improvements, writings,
documentation, data and other rights (whether or not protectable
under state, federal, or foreign patent, trademark, copyright or
similar laws) that are conceived, discovered, invented,
developed, created, made or reduced to practice by GTC, alone or
jointly with others, in performance of the Project.
8.2 OWNERSHIP.
a. All Rights and Developments relating to Alexion's Product
or its use shall be solely owned by Alexion, regardless
of the designation of inventorship between the parties
and their employees.
GTC shall promptly notify Alexion of all such Rights and
Developments and shall transfer and assign to Alexion all
rights, title and interest in the Rights and
Developments, and Alexion, in its sole discretion, may
apply for patents and other intellectual property rights
relating to the Rights and Developments. GTC shall, at
Alexion's request, execute such declarations, assignments
and other documents required by Alexion to effect such
transfer and assignment and any intellectual property
applications.
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b. All Rights and Developments relating to the Expression
Technology shall be solely owned by GTC, regardless of
the designation of inventorship between the parties and
their employees.
Alexion shall promptly notify GTC of all such Rights and
Developments and shall transfer and assign to GTC all
rights, title and interest in the Rights and
Developments, and GTC, in its sole discretion, may apply
for patents and other intellectual property rights
relating to the Rights and Developments. Alexion shall,
at GTC's request, execute such declarations, assignments
and other documents required by GTC to effect such
transfer and assignment and any intellectual property
applications.
c. All transgenic animals expressing Alexion's Product which
are generated by GTC as part of the Project performed
under this Agreement shall be solely owned by Alexion,
regardless of the designation of inventorship between the
parties and their employees, [***].
In the case where Alexion uses the animals to make at
least a portion of Alexion's commercial Product and where
GTC does not manufacture all of Alexion's commercial
Product, [***] from the commercial manufacture of
transgenic Product on Alexion's behalf.
d. All other Rights and Developments shall be jointly owned
by the parties, regardless of the designation of
inventorship between the parties and their employees.
8.3 PATENT RIGHTS. Any patent applications covering Rights and
Developments owned by Alexion will be prepared and filed by
Alexion, with expenses paid [***]. Any patent applications
covering Rights and Developments owned by GTC or jointly owned by
the parties will be prepared and filed by GTC, [***].
If either party elects not to file or maintain an application
or patent covering any jointly owned Rights and Developments,
that party shall promptly notify the other party, which shall
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have the right to file or maintain such applications or patents,
at its expense. Inventorship will be determined according to U.S.
patent law.
8.4 INFRINGEMENT OF THIRD PARTY PATENTS.
a. GTC warrants that it shall not knowingly infringe any
existing third-party patents or other intellectual
property rights of any third party relating to the
transgenic expression vectors, clarification and other
processes used in connection with the Project.
x. Xxxxxxx warrants that it shall not knowingly infringe any
existing thirdparty patents or other intellectual
property rights of any third party relating to the DNA
supplied by Alexion to GTC hereunder and used in
connection with the Project.
9. INDEMNIFICATION. Alexion and GTC shall each defend, indemnify and hold the
other and it's affiliates and the respective directors, officers, employees and
agents and affiliates, harmless from and against any and all losses, damages,
liabilities, claims, demands, judgements, settlements, costs and expenses
(including, without limitation, reasonable attorneys' fees and other costs of
defense) arising out of, relating to or resulting from the breach of any of
their respective representations, warranties and covenants contained within this
Agreement or their respective negligence or willful misconduct.
10. TERM AND TERMINATION.
10.1 TERM. The term of this Agreement shall commence on the Effective
Date. Unless earlier terminated in accordance with the provisions
of this Agreement, the Project shall terminate upon GTC's making
available for delivery to Alexion:
a. the Final Report in a form reasonably satisfactory to
Alexion,
b. any transgenic founder animals generated for Alexion's
Product, and
c. samples of deliverable Product as indicated in the
Project Work Plan.
10.2 TERMINATION BY EITHER PARTY. This Agreement may be terminated by
either party in the event of a material breach by the other party
of the terms hereof; provided, however, the nondefaulting party
shall first give to the defaulting party written notice of the
proposed termination of this Agreement, specifying the grounds
therefore, and the defaulting party shall have thirty (30) days
after such notice is given to cure the breach. If not so cured,
this Agreement shall terminate at the expiration of such thirty
(30) days.
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Upon termination, neither party will have any further obligations
under this Agreement, except (a) the liabilities accrued through
the date of termination and (b) the obligations which by their
terms survive termination shall survive. Upon termination, GTC
will return to Alexion or dispose of any of Alexion's Product and
any transgenic animals generated by GTC pursuant to the Project
in accordance with Alexion's instructions.
10.3 CONTINUING OBLIGATION. The termination or expiration of this
Agreement shall not relieve either party of its obligations to
the other party in respect of (a) the confidentiality or use of
Confidential Information and, (b) any publication or presentation
relating to the Project, or (c) indemnification as provided in
Section 9.
10.4 FURTHER CLINICAL DEVELOPMENT AND COMMERCIAL SUPPLY AGREEMENT. In
the event that the parties decide to enter into an agreement for
the supply of Product for clinical and/or commercial use, GTC
agrees to scale up the transgenic production herd, develop and
scale up a primary recovery step (Tangential Flow Filtration,
"TFF"), and assist Alexion [***]. The parties agree to commence
good faith negotiations in an effort to reach agreement on the
terms of such an agreement, such negotiations to ensure an
efficient transition from development to clinical and/or
commercial activities and not to unnecessarily delay the
development of transgenically-produced Product.
In the event of an agreement to produce Product for clinical
studies, GTC will provide the required Product at [***].
In the event of entering into a Development and Commercial
Agreement, the key compensation elements will be as follows:
a. Within a Development and Commercial Agreement constructed
under industry standard terms and conditions, GTC will
provide Product for commercial activities at [***]
at a commercially relevant scale for Alexion.
[***] TFF stage Product. This would result in an
effective transfer price to Alexion of [***] of TFF
stage Product). In the event GTC is able to lower its
costs, GTC and Alexion will share equally in the
benefits;
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b. [***] will pay the capital costs associated with herd
scale up and the construction of a dedicated barn, dairy
and primary recovery (TFF) suite as agreed to by the
parties;
x. Xxxxxxx will pay GTC a royalty of [***].
11. ASSIGNABILITY. This Agreement, and the rights and obligations hereunder,
may not be assigned or transferred by either party without the prior written
consent of the other party, such consent not to be unreasonably withheld, except
that GTC or Alexion may assign this Agreement to an affiliated company or in
connection with the merger, consolidation or sale of all or substantially all of
it assets.
12. PUBLICATION. Any publication or presentation relating to the Project must
first be approved in writing by both parties, such approval not to be
unreasonably withheld. Each party agrees to submit, for review, any proposed
publication (including any writing to be presented orally) relating to the
Project at least forty-five (45) days prior to submission for publication or
presentation. If either party requests a delay in publication or presentation,
the other party agrees to delay the publication or presentation, for a period of
ninety (90) days from the date of such request. Such period may be extended, if
necessary, for an additional period mutually acceptable to the parties.
Notwithstanding the foregoing, both parties agree that no publication or
presentation shall contain Confidential Information with respect to which it has
confidentiality obligations pursuant to Section 7 hereof.
13. GOVERNING LAW AND ENTIRETY. The validity, interpretation and performance of
this Agreement shall be governed and construed in accordance with the laws of
the State of Massachusetts, U.S.A. This document along with any Confidentiality
Agreement, constitutes the full understanding of the parties with respect to the
subject matter hereof, and a complete and exclusive statement of the terms of
their agreement, and no terms, conditions, understanding or agreement purporting
to modify or vary the terms of this Agreement shall be binding unless made in
writing and signed by the party to be bound.
14. NO WAIVER. No waiver of any term or condition of this Agreement shall be
valid or binding on either party unless agreed in writing by the party to be
charged. The failure of either party to enforce at any time any of the
provisions of this Agreement, or the failure to require at any time performance
by the other party of any of the provisions of this Agreement, shall in no way
be construed to be a present or future waiver of such provisions, nor in any way
affect the validity of either party to enforce each and every such provision
thereafter.
15. COUNTERPARTS. This Agreement may be executed in two counterparts, each of
which shall be deemed an original and both of which together shall constitute
one instrument.
16. INDEPENDENT CONTRACTORS. The relationship of Alexion and GTC established by
this Agreement is that of independent contractors, and nothing contained in this
Agreement shall be
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construed to: (a) give either party the power to direct or control the
day-to-day activities of the other, (b) constitute the parties as partners,
joint venturers, co-owners or otherwise as participants in a joint or common
undertaking; or (c) allow a party to create or assume any obligation on behalf
of the other party for any purpose whatsoever. Nothing in this Agreement will
give rise to the creation of any labor relation by and between either party and
any employees of the other party.
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IN WITNESS WHEREOF, duly-authorized representatives of the parties have
signed this Agreement as a document under seal of the Effective Date.
ALEXION PHARMACEUTICALS INC. GENZYME TRANSGENICS
CORPORATION
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxxxx X. Xxxxx
------------------------------- ---------------------------------
Print Name: Xxxxx X. Xxxxxx Print Name: Xxxxxxx X. Xxxxx
Title: Exec. Vice-President and COO Title: Vice-President, Commercial
Duly Authorized Development Duly Authorized
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SECTION B
PROJECT WORK PLAN
WORK PLAN OBJECTIVES:
1. Generate founder goats transgenic for Product
2. Evaluate transgenic technology for the manufacture of Product for
clinical use at a scale of [***].
3. Provide Product samples for in vitro testing
4. Deliver to Alexion an amount of clarified intermediate Product which
yields [***], as produced by a development scale purification process
consistent with industry standards.
WORK PLAN ACTIVITIES:
1. [***]
2. [***]
3. [***]
4. [***]
5. [***]
6. [***]
7. [***]
8. [***]
9. [***]
10. [***]
11. [***]
12. [***]
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FROM GTC
GTC agrees to conduct the Project as described below. GTC shall provide
personnel, facilities and resources as required to perform the Project.
[***]
A provisional timeline is set forth below:
TIME ACTIVITY
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
[***] [***]
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FROM ALEXION
In connection with the Project, Alexion shall supply GTC with the following:
(a) [***];
(b) [***];
(c) [***];
(d) [***].
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