Exhibit 10.18
STRATEGIC ALLIANCE AGREEMENT
BETWEEN
WATERS TECHNOLOGIES CORPORATION
and
VARIAGENICS, INC.
June 21, 2000
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
STRATEGIC ALLIANCE AGREEMENT
This STRATEGIC ALLIANCE AGREEMENT (the "Agreement") is entered into as of
June 21, 2000, by and between Waters Technologies Corporation, a Delaware
corporation, having an address of 00 Xxxxx Xxxxxx, Xxxxxxx, Xxxxxxxxxxxxx 00000
("WATERS") and Variagenics, Inc., a Delaware corporation, having an address of
00 Xxxxxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000-0000 ("VARIAGENICS").
WHEREAS, VARIAGENICS is the owner and/or licensee of technology related to,
and has expertise in the development and use of, reagents for use in the
detection of genetic variances, including single nucleotide polymorphisms; and
WHEREAS, WATERS is the owner and/or licensee of technology related to, and
has expertise in, the development, manufacture and use of analysis and
purification devices and has expertise in the manufacturing and marketing of
reagent kits; and
WHEREAS, the parties desire to enter into a strategic alliance (the
"Strategic Alliance") for the purposes of combining their technologies to
develop, manufacture and market certain products designed for use in the
Pharmaceutical Development Field (as defined herein).
NOW, THEREFORE, in consideration of the mutual covenants contained herein,
and for other good and valuable consideration, the parties hereto, intending to
be legally bound, hereby agree as follows:
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
1. DEFINITIONS
Whenever used in this Agreement with an initial capital letter, the terms
defined in this Annex 1 shall have the meanings specified.
1.1 "Affiliate" means any corporation, firm, partnership or other entity
which directly or indirectly controls or is controlled by or is under common
control with a party to this Agreement. "Control" means ownership, directly or
through one or more Affiliates, of more than fifty percent (50%) of the shares
of stock entitled to vote for the election of directors, in the case of a
corporation, or more than fifty percent (50%) of the equity interests in the
case of any other type of legal entity, status as a general partner in any
partnership, or any other arrangement whereby a party controls or has the right
to control the Board of Directors or equivalent governing body of a corporation
or other entity.
1.2 "Alliance Program" means the collaborative commercial development
program to be conducted by VARIAGENICS and WATERS pursuant to this Agreement and
the Marketing Plan.
1.3 "Alliance Steering Committee" or "ASC" means the committee of
VARIAGENICS and WATERS representatives established pursuant to Section 3 hereof
to administer the affairs of the Strategic Alliance.
1.4 "Confidential Information" means all tangible embodiments of Technology
and all information (including but not limited to information about any element
of Technology) which is disclosed by one party to the other hereunder except to
the extent that such information (i) as of the date of disclosure is
demonstrably known to the party receiving such disclosure or its
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Affiliates, as shown by written documentation, other than by virtue of a prior
confidential disclosure to such party or its Affiliates; (ii) as of the date of
disclosure is in, or subsequently enters, the public domain, through no fault or
omission of the party receiving such disclosure; or (iii) as of the date of
disclosure or thereafter is obtained from a third party free from any obligation
of confidentiality to the disclosing party; (iv) is created or developed by a
receiving party, without use of the Confidential Information of the disclosing
party by persons who did not have access to the disclosing party's Confidential
Information.
1.5 "Consultative Decision" means a decision on a Strategic Alliance matter
which shall be made by the Alliance Steering Committee after appropriate
consultations and discussions by the Alliance Steering Committee or, if the
Alliance Steering Committee shall be unable to reach a decision concerning the
subject matter, by VARIAGENICS if the decision is identified as an VARIAGENICS
Consultative Decision hereunder or by WATERS if the decision is identified as a
WATERS Consultative Decision hereunder.
1.6 "Effective Date" means the date first written above.
1.7 "Field" means the detection of genomic variances in human, agricultural
and animal health research and development and does not include single
nucleotide polymorphism discovery, commercial genotyping or haplotyping of
plants, or clinical diagnostics, including genotyping or haplotyping of human or
animal patients to determine (i) whether to administer a particular drug to a
particular patient, (ii) which drug to
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
administer to a particular patient, (iii) disease predisposition, or (iv) the
presence of disease.
1.8 "Joint Decision" means a decision with respect to a Strategic Alliance
matter which shall be made by the Alliance Steering Committee after appropriate
consultations and discussions concerning the same by the representatives of
VARIAGENICS and WATERS to the ASC. Joint Decisions shall include any decisions
expressly identified as such hereunder and any other decisions specifically
reserved to the Alliance Steering Committee hereunder.
1.9 "Joint Patent Rights" means Patent Rights with respect to Joint
Technology.
1.10 "Joint Technology" has the meaning set forth in Section 11.2.3.
1.11 "Licensed Product" means any NuCleave-TM- Kit, the development,
manufacture, use, or sale of which, (i) absent the licenses granted under
this Agreement, would infringe an issued patent which is part of the
VARIAGENICS Patent Rights, (ii) is within the claim of a pending application
which is part of the VARIAGENICS Patent Rights, or (iii) utilizes VARIAGENICS
Technology, and that is designated as a Licensed Product by the ASC pursuant
to Section 4.3.2. "Licensed Product" does not include any non-consumable
instrumentation and accessories sold or distributed in conjunction with the
Licensed Products.
1.12 "Marketing Plan" has the meaning set forth in Section 9.1.
1.13 "Net Sales" means the gross invoiced sales price of any Licensed
Product charged by WATERS or its Affiliates or licensees
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
for the sale of a Licensed Product in arm's length sales to third parties, less
the following amounts incurred by WATERS or its Affiliates or licensees with
respect to such sale of the Licensed Product to the extent separately included
in the invoice for the Licensed Product as part of the gross invoiced sales
price:
(a) trade, cash and quantity discounts or rebates actually allowed or
taken;
(b) credits or allowances given or made for rejection of or return
of, and for uncollectible amounts on, previously sold Licensed
Products or for retroactive price reductions;
(c) charges for insurance, freight, and other transportation costs
directly related to the delivery of Licensed Product;
(d) sales, transfer and other excise taxes levied on the sale or
delivery or performance of a Licensed Product (including any tax
such as a value added or similar tax or government charge) borne
by the seller thereof, other than franchise or income tax of any
kind whatsoever.
Net Sales of Licensed Products shall not include revenues from sales or
transfers between Waters and its Affiliates or licensees, unless the Licensed
Product is consumed by the Affiliate or licensee.
1.13A "Next Generation NuCleave Technology" means Technology relating to
(a)[ ] or increasing the sensitivity of the NuCleave Reagents which
results in a decrease of PCR reaction volume to [ ] microliters or less
(the "Generation NuCleave Technology") and (b) Technology that employs
dinucleotide chemistry (the "Generation 4 NuCleave Technology").
1.14 "NuCleave-TM- Kit" means a package containing one or more WATERS
Proprietary De-salting Plates and a supply of NuCleave-TM-
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Reagents designed for use on a NuCleave-TM-System to perform genotyping or
haplotyping assays in the Pharmaceutical Development Field.
1.15 "NuCleave-TM- Reagents" means those reagents listed on Schedule
1.15.
1.16 "NuCleave-TM- System" means a mass spectrometer, robotics platform
and accompanying software supplied by VARIAGENICS designed for use to perform
genotyping or haplotyping assays in the Pharmaceutical Development Field. It
is anticipated by both parties that WATERS will become an authorized supplier
and seller of the mass spectrometer component of NuCleave-TM-Systems as soon
as WATERS demonstrates to VARIAGENICS' reasonable satisfaction its ability to
provide a mass spectrometer with appropriate performance characteristics.
1.17 "NuCleave-TM- Technology" means all Technology relating to
NuCleave-TM- Systems, NuCleave-TM- Reagents or the manufacture or use
thereof. For the avoidance of doubt, NuCleave-TM- Technology does not include
Next Generation NuCleave-TM- Technology.
1.18 THIS SECTION INTENTIONALLY LEFT BLANK.
1.19 "Patent Rights" means the rights and interests in and to issued
patents and pending patent applications (which for purposes of this Agreement
shall be deemed to include certificates of invention and applications for
certificates of invention and priority rights) in any country, including all
provisional applications, substitutions, continuations, continuations-in-part,
divisions, and renewals, all letters patent granted thereon, and all reissues,
reexaminations and extensions thereof and all supplementary protection
certificates,
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
whether owned or licensed in by a party with the right to sublicense.
"VARIAGENICS Patent Rights" means Patent Rights with respect to VARIAGENICS
Technology including, without limitation, those Patent Rights listed on Schedule
1.19A. "WATERS Patent Rights" means Patent Rights with respect to WATERS
Technology, including, without limitation, those Patent Rights listed on
Schedule 1.19B.
1.20 "Pharmaceutical Development Field" means detection of genomic
variations in human clinical trials of pharmaceutical products pursuant to an
Investigational New Drug Application filed with the U.S.F.D.A. or its equivalent
in another jurisdiction, and does not include single nucleotide polymorphism
discovery, commercial genotyping or haplotyping of plants, or clinical
diagnostics, including genotyping or haplotyping of human or animal patients to
determine (i) whether to administer a particular drug to a particular patient,
(ii) which drug to administer to a particular patient, (iii) disease
predisposition, or (iv) the presence of disease.
1.21 "Strategic Alliance" means the association of VARIAGENICS and WATERS
established pursuant to Article 2 of this Agreement for the purposes set forth
therein.
1.22 "Technology" means and includes all inventions, discoveries, trade
secrets know-how, data, and proprietary methods and materials, whether or not
patentable, including but not limited to, samples of, methods of production
or use of, and structural and functional information pertaining to
NuCleave-TM- Reagents and WATERS Proprietary De-salting Plates. "Technology"
of a party includes Technology owned by a party or licensed to that party
with a right to grant sublicenses.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
1.23 "Term" means the term of this Agreement as set forth in Section 13.1
hereof.
1.24 "Territory" means the world.
1.24A "VALID CLAIM" shall mean (i) a claim of any issued, unexpired patent
which is contained within Patent Rights and which has not been held invalid,
unpatentable or unenforceable by a final decision, which is unappealed or
unappealable, of a court of competent jurisdiction or of an administrative
agency having authority over patents; or (ii) a claim in any pending patent
application.
1.25 "VARIAGENICS Background Technology" means Technology of VARIAGENICS
that exists as of the Effective Date and that is useful in developing,
manufacturing, and utilizing NuCleave-TM- Reagents for use in NuCleave-TM-
Kits in the Pharmaceutical Development Field.
1.26 "VARIAGENICS Consultative Decision" means a Consultative Decision
which shall be made by VARIAGENICS, subject to the terms hereof, if, after
appropriate consultations and discussions by the Alliance Steering Committee,
the Alliance Steering Committee shall be unable to reach a decision concerning
the subject matter thereof. All Consultative Decisions which are VARIAGENICS
Consultative Decisions are specifically identified as such hereunder.
1.27 "VARIAGENICS Decision" means a decision with respect to a Strategic
Alliance matter which VARIAGENICS shall make in its sole discretion, subject to
the terms hereof, without the necessity of prior consultations or discussions by
the Alliance Steering Committee or between the parties. All decisions which
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
are VARIAGENICS Decisions are specifically identified as such hereunder.
1.28 "VARIAGENICS Program Technology" has the meaning set forth in Section
11.2.1 hereof.
1.29 "VARIAGENICS Technology" means VARIAGENICS Background Technology
and VARIAGENICS Program Technology. For the avoidance of doubt, VARIAGENICS
Technology does not include Technology relating to [ ] or Technology
relating to increasing the sensitivity of the NuCleave Reagents which results
in a decrease of PCR reaction volume to [ ] microliters or less.
1.30 "WATERS Background Technology" means Technology of WATERS that
exists as of the Effective Date and that is useful in developing,
manufacturing and utilizing WATERS Proprietary De-salting Plates for use in
NuCleave-TM- Kits in the Field.
1.31 "WATERS Consultative Decision" means a Consultative Decision which
shall be made by WATERS, subject to the terms hereof, if, after appropriate
consultations and discussions by the Alliance Steering Committee, the Alliance
Steering Committee shall be unable to reach a decision concerning the subject
matter thereof. All Consultative Decisions which are WATERS Consultative
Decisions are specifically identified as such hereunder.
1.32 "WATERS Decision" means a decision with respect to a Strategic
Alliance matter which WATERS shall make in its sole discretion, subject to the
terms hereof, without the necessity of prior consultations or discussions by the
Alliance Steering Committee or between the parties. All decisions which are
WATERS Decisions are specifically identified as such hereunder.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
1.33 "WATERS Program Technology" has the meaning set forth in Section
11.2.2 hereof.
1.33A "WATERS Proprietary De-salting Plate" means WATERS' proprietary 384
well plate for use in genotyping or haplotyping assays in the Field meeting the
specifications set forth in Schedule 1.33A.
1.34 "WATERS Technology" means WATERS Background Technology and WATERS
Program Technology.
2. FORMATION OF THE ALLIANCE
2.1 FORMATION. The parties hereto hereby agree to associate themselves for
the purpose of jointly developing, manufacturing, marketing, promoting,
distributing and selling Licensed Products for use in the Field in the
Territory. The Strategic Alliance shall be conducted, operated and administered
solely in accordance with the terms of this Agreement, and no separate or
jointly owned corporate or other entity or entities shall be established for the
purpose of conducting or administering the joint efforts and endeavors of the
parties hereunder.
2.2 RELATIONSHIP OF PARTIES.
2.2.1 PURPOSES AND SCOPE. The Strategic Alliance is limited solely to
the Field in the Territory and to the activities, rights and obligations as set
forth in this Agreement. Nothing in this Agreement shall be construed (i) to
create or imply a general partnership, limited partnership or other legal entity
between the parties, (ii) to make either party the agent of the other for any
purpose, (iii) to alter, amend, supersede or vitiate any other arrangements
between the parties
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
with respect to any subject matters not covered hereunder, (iv) to give either
party the right to bind the other, (v) to create any duties or obligations
between the parties except as expressly set forth herein, or (vi) to grant any
direct or implied licenses or any other right other than as expressly set forth
herein.
2.2.2 ETHICAL CONDUCT. In carrying out its responsibilities under this
Agreement, each party agrees that, in all material respects, its activities will
be conducted in compliance with all applicable laws, rules and regulations in
jurisdictions in which the activities are conducted.
2.2.3 USE OF THIRD PARTIES. Either party may utilize third parties for
the manufacture of any materials to be supplied by such party hereunder, subject
to the prior approval of the Alliance Steering Committee. Without limiting the
generality of the foregoing, WATERS will comply with all U.S. laws and
regulations controlling the export of commodities and technical data.
2.3 RESEARCH LICENSES. Unless prohibited by obligations to third parties,
VARIAGENICS and/or WATERS, as the case may be, shall grant to each other such
royalty-free licenses or sublicenses in the Field to Patent Rights or Technology
owned or controlled by such party or its Affiliates, if any, as the Alliance
Steering Committee shall deem reasonably necessary in order to conduct the
internal research and development activities as contemplated by contemplated by
the Development Plan (defined below).
2.4 ADMINISTRATION; DEVELOPMENT PLAN. The Alliance Program and operations
of the Strategic Alliance shall be administered by the Alliance Steering
Committee in accordance with the provisions
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
of Article 3 hereof. Within sixty (60) days following the Effective Date, the
parties will adopt a development plan for the Alliance Program (the "Development
Plan") that includes a detailed description of the steps to be taken by the
parties to complete the development and deployment of the Licensed Products
including the responsibilities of each party, a schedule for completing the
development program and the budget for such development program. Each party will
use commercially reasonable efforts to implement the Development Plan in
accordance with the terms of this Agreement.
2.5 MUTUAL SUPPORT. Each party shall, upon reasonable request by the other
party, meet with existing or prospective investors, underwriters or investment
bankers of the other party to discuss the Alliance.
3. ALLIANCE STEERING COMMITTEE
3.1. DECISION MAKING. Subject to any express provisions of this Agreement
designating decisions as Consultative Decisions, VARIAGENICS Decisions or WATERS
Decisions, or otherwise specifically reserving to either VARIAGENICS or WATERS,
as the case may be, the right to make unilateral decisions as provided herein,
the general affairs and activities of the Strategic Alliance and the research,
development, supply, licensing and marketing activities of the Strategic
Alliance described herein shall be administered, managed and coordinated by a
committee (the "Alliance Steering Committee") consisting of an equal number
(which number shall be two (2) unless the parties otherwise agree) of
representatives designated by each of VARIAGENICS and WATERS.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
3.2 ALLIANCE STEERING COMMITTEE DESIGNEES. Each party shall designate one
of its representatives on the Alliance Steering Committee as its "Co-Chair".
Each party shall have the right at any time to substitute individuals,
reasonably acceptable to the other party, on a permanent or temporary basis, for
any of its previously designated representatives to the Alliance Steering
Committee, including its Co-Chair, by giving written notice thereof to the other
party.
Initial designees of the parties to the Alliance Steering Committee shall
be as follows:
For VARIAGENICS: Xxxx X. Xxxxxx, Ph.D., Co-Chair
Xxxxxx X. Xxxxx
For WATERS: Xxxxxxx X. Xxxxx, Co-Chair
Xxx X. Xxxx
3.3 ALLIANCE STEERING COMMITTEE MEETINGS.
3.3.1 SCHEDULE OF MEETINGS. The Alliance Steering Committee shall
establish a schedule of times for meetings, taking into account, without
limitation, the planning needs of the Alliance Program herein described and
the need of the Alliance Steering Committee to consult and/or render
decisions required of it hereunder. The Alliance Steering Committee is
expected to meet at least semi-annually and will do so at the request of
either party. Meetings may also be convened upon the determination of the
Co-Chairs, or either of them, by written notice thereof to the members of the
Alliance Steering Committee, that a meeting of the Alliance Steering
Committee is required to discuss and/or resolve any matter or matters with
respect to the Strategic Alliance. Meetings shall alternate between
Cambridge,
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Massachusetts and Milford, Massachusetts or another mutually agreed upon
location; provided, however, that the parties may mutually agree to meet by
teleconference or video conference or by e-mail. An e-mail meeting shall be
deemed to have occurred provided that each member of the Alliance Steering
Committee indicates via e-mail its vote on each matter to the Co-Chairs.
Representatives of each party or of its Affiliates, in addition to the members
of the Alliance Steering Committee, may attend Alliance Steering Committee
meetings as non-voting observers at the invitation of either party with the
approval of the other party, which shall not be unreasonably withheld.
3.3.2 QUORUM; VOTING; DECISIONS. At each Alliance Steering Committee
meeting, at least two members designated by each party shall constitute a
quorum. Each Alliance Steering Committee member shall have one vote on all
matters before the Alliance Steering Committee, provided that, if a quorum is
present, the member or members of each party present at an Alliance Steering
Committee meeting shall have the authority to cast the votes of any of such
party's members on the Alliance Steering Committee who are absent from the
meeting. Provided a quorum is present, all decisions of the Alliance Steering
Committee shall be made by majority vote of all of the members. Whenever any
action by the Alliance Steering Committee is called for hereunder during a time
period in which the Alliance Steering Committee is not scheduled to meet, the
Co-Chairs shall cause the Alliance Steering Committee to take the action in the
requested time period by calling a special meeting or by action without a formal
meeting by written memorandum signed by the members of the Alliance Steering
Committee. In the event that the Alliance
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Steering Committee is unable to resolve any matter before it, such matter shall
be resolved as set forth in Section 3.7 hereof.
3.3.3 MINUTES. The Alliance Steering Committee shall keep accurate
minutes of its deliberations that record all proposed decisions and all actions
recommended or taken. Drafts of the minutes shall be delivered to the Co-Chairs
of the Alliance Steering Committee within a reasonable time not to exceed five
(5) days after the meeting. The party hosting the meeting shall be responsible
for the preparation and circulation of the draft minutes. The Co-Chairs will
designate the responsibility in the case of videoconference, teleconference, or
e-mail meetings. Draft minutes shall be edited by the Co-Chairs and shall be
issued in final form within a reasonable time not to exceed fifteen (15) days
after the meeting only with their approval and agreement as evidenced by their
signatures on the minutes.
3.3.4 EXPENSES. VARIAGENICS and WATERS shall each bear all expenses of
their respective Alliance Steering Committee members related to their
participation on the Alliance Steering Committee and attendance at Alliance
Steering Committee meetings.
3.4 PLANNING RESPONSIBILITIES. The Alliance Steering Committee shall plan,
administer and monitor the Alliance Program. In particular, the Alliance
Steering Committee shall review and approve the Development Plan and the
Marketing Plan, review and monitor the progress of the Development Plan and the
Marketing Plan and recommend necessary adjustments as the plans are carried out.
In planning and monitoring the Alliance Program and the Development Plan and
Marketing Plan, the Alliance Steering Committee shall allocate tasks and
responsibilities
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
taking into account each party's respective specific research,
development, manufacturing and marketing capabilities and expertise in order to
avoid duplication and to enhance synergies.
3.5 DECISION MAKING RESPONSIBILITIES. The Alliance Steering Committee shall
be solely responsible for making all decisions specified as "Joint Decisions"
hereunder and all decisions specifically reserved to it hereunder. All decisions
by the Alliance Steering Committee are binding upon the parties. It is
understood and agreed, however, that decisions requiring the expenditure of
funds by either party shall be subject to approval by that party in accordance
with its established procedures for approving expenditures of similar magnitude.
Following approval of an expenditure decision by the Alliance Steering
Committee, the Alliance Steering Committee shall notify the party of such
recommendation and seek a prompt decision regarding same from the parties.
3.6 INTERESTS OF THE PARTIES. THIS SECTION INTENTIONALLY OMITTED.
3.7 DISPUTE RESOLUTION. In the event that the Alliance Steering Committee
shall not be able to reach a decision or take an action on any matter which is
reserved to the Alliance Steering Committee hereunder, then:
(i) as to Joint Decisions or any other decisions specifically
reserved to the Alliance Steering Committee hereunder, the matter
in question shall first be referred for resolution to the chief
executive officer of VARIAGENICS and the chief executive officer
of WATERS (or a designated senior officer of WATERS), and in the
event that
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
said officers shall be unable to resolve such matter after
reasonable efforts to do so and after the passage of a reasonable
period of time under the relevant circumstances, but in no event
more than thirty (30) days, such matter shall be resolved in
accordance with the procedures for resolving disputes under this
Agreement as set forth in Section 16, but the failure to resolve
the matter by mediation shall not result in resolution by binding
arbitration.
(ii) as to VARIAGENICS Consultative Decisions, the matter shall be
resolved as directed by VARIAGENICS.
(iii)as to WATERS Consultative Decisions, the matter shall be resolved
as directed by WATERS.
(iv) VARIAGENICS Decisions and WATERS Decisions shall not be submitted
to the Alliance Steering Committee and shall not be subject to
this Section 3.7.
4. ALLIANCE PROGRAM
4.1 OBJECTIVES OF THE ALLIANCE PROGRAM. The objective of the Alliance
Program shall be to integrate the VARIAGENICS Technology, including
NuCleave-TM- Reagents, with the WATERS Technology, including WATERS
Proprietary De-salting Plates, to develop NuCleave-TM- Kits for manufacture
and sale by WATERS hereunder. In carrying out the Alliance Program,
VARIAGENICS and WATERS shall each use commercially reasonable efforts to
perform such tasks as are set forth to be performed by it under the terms of
this Agreement and the Marketing Plan in accordance with all
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
applicable laws, ordinances, rules, regulations, orders, licenses and other
requirements now or hereafter in effect.
4.2 PRODUCT APPROVAL BY ALLIANCE STEERING COMMITTEE. The initial
Licensed Product will be a NuCleave-TM- Kit containing the
NuCleave-TM- Reagents and WATERS Proprietary De-salting Plates described in
Schedule 4.2. Additional Licensed Products may be added to the Alliance
Program using the following procedure: whenever a party identifies any
additions, developments, enhancements, updates and other changes in a
NuCleave-TM- Kit, the NuCleave-TM- Reagents or the NuCleave-TM- System, and
any new designs for a NuCleave-TM- Kit, the NuCleave-TM- Reagents or any
other opportunity to develop a NuCleave-TM- Kit as a new Licensed Product or
family of Licensed Products (a "Proposed Alliance Project"), which in such
party's reasonable judgment should be pursued, that party shall promptly
present the potential project to the Alliance Steering Committee for review
and consideration of the Proposed Alliance Project. Promptly following such
notification, the Alliance Steering Committee shall determine whether to
accept or reject the Proposed Alliance Project for the Alliance. Decisions of
the ASC under this Section shall be Joint Decisions and shall not be subject
to the dispute resolution procedures in Section 3.7.
4.2A GENERATION 3 NUCLEAVE TECHNOLOGY. (a) VARIAGENICS shall not enter
into any agreement with a third party relating to commercialization (including
manufacturing, development, marketing or disribution) of Generation 3
NuCleave Technology in any field(s), UNLESS VARIAGENICS shall first offer
such opportunity to WATERS and provide WATERS an opportunity to obtain an
exclusive license for the commercialization of the Next Generation NuCleave
Technology within such field(s). For purposes of offering WATERS any such
opportunity, prior to providing any such notice to a third party, VARIAGENICS
shall provide WATERS with notice of such opportunity, including sufficient
technical detail to permit WATERS to evaluate its interest in the opportunity.
(b) WATERS shall notify VARIAGENICS within [ ] days following
receipt of VARIAGENICS' notice whether or not WATERS is interested in such
opportunity, including a description of the terms on which WATERS wishes to
acquire such license and the parties shall have a period of [ ]
days from the date of WATERS' notice to negotiate in good faith a mutually
acceptable development and license agreement for such opportunity. If the
parties cannot conclude a mutually acceptable agreement within such
[ ]-day period, and the parties are not willing to extend the
period for negotiation, then WATERS shall provide VARIAGENICS with a written
"last best offer" (which VARIAGENICS shall not disclose to any third party)
and the right of first offer shall expire with respect to such opportunity
and VARIAGENICS may negotiate and enter into an agreement with a third party
concerning such research and development opportunity; PROVIDED, HOWEVER, that
any agreement that VARIAGENICS enters into with such third party contains
terms that are in the aggregate more favorable to VARIAGENICS than those
offered by WATERS in such last best offer.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(c) Notwithstanding VARIAGENICS' right to conclude an agreement with a
third party for the commercialization of the Generation 3 NuCleave Technology
under Section 4.2A(b), in the event that WATERS and VARIAGENICS are not able
to conclude a mutually acceptable agreement for the commercialization of
Generation 3 NuCleave Technology, VARIAGENICS shall not, during the period
prior to the fourth anniversary of the achievement of the first milestone in
Section 7.1, make, have made, manufacture, use, have used, sell, have sold,
offer for sale, lease, import or have imported the Generation 3 NuCleave
Technology for use in the [ ] and will not directly or indirectly
supply the Generation 3 NuCleave Technology to entities who VARIAGENICS knows
or has reason to believe will use the Generation 3 NuCleave Technology in the
[ ].
4.2B GENERATION 4 NUCLEAVE-TM- TECHNOLOGY. During a period of [ ] months
from the date hereof, VARIAGENICS shall not enter into any agreement with a
third party relating to commercialization (including research and
development, manufacturing, marketing and distribution) of Generation 4
NuCleave-TM- Technology. During such [ ] month period, the parties shall
negotiate in good faith a mutually acceptable development and license
agreement for such opportunity. If WATERS concludes that it does not wish to
continue such negotiations, it will promptly notify VARIAGENICS. Upon such
notice, or if the parties cannot conclude a mutually acceptable agreement
within such [ ] month period, and the parties are not willing to extend the
period for negotiation, then VARIAGENICS may negotiate and enter into an
agreement with a third party concerning commercialization of Generation 4
NuCleave-TM- Technology without further obligation to WATERS.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
4.3 DEVELOPMENT AND COMMERCIALIZATION.
4.3.1 APPROVED ALLIANCE PROJECTS. If the ASC decides to pursue a
Proposed Alliance Project, the Parties shall agree upon their responsibilities
in the conduct of the Project.
4.3.2 SUCCESSFUL DEVELOPMENT EFFORTS. If the R&D efforts in
connection with a Alliance Project are successful, the Alliance Steering
Committee will decide whether to designate the resulting NuCleave-TM- Kit as
a Licensed Product. Upon such designation, such NuCleave-TM- Kit shall be
subject to the license set forth in Article 6.
4.4 DUE DILIGENCE. Each party will apply commercially reasonable
diligent efforts to the performance of all aspects of its obligations under
the Alliance Program. Without limiting the generality of the foregoing,
VARIAGENICS will apply commercially reasonable diligent efforts to make
NuCleave-TM- Reagents available to the Strategic Alliance, and WATERS will
apply commercially reasonable diligent efforts to make WATERS Proprietary
De-salting Plates and manufacturing facilities and marketing resources
available to the Alliance.
4.5 MUTUAL OBLIGATIONS.
4.5.1 COLLABORATIVE EFFORTS AND REPORTS. The parties agree that the
successful execution of the Alliance Program will require the collaborative use
of both parties' areas of expertise. The parties shall keep the Alliance
Steering Committee fully informed about the status of the portions of the
Alliance Program they respectively perform separately and/or jointly.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
4.5.2 INFORMATION EXCHANGE. Subject to any confidentiality obligations
to third parties, scientists at VARIAGENICS and WATERS shall cooperate in the
performance of the Alliance Program and shall exchange information and materials
as necessary to carry out the Alliance Program. The parties expect that such
exchange of information and materials may involve short-term on-site visits by
scientists of one party to the facilities of the other to encourage close
collaboration between the scientists of VARIAGENICS and WATERS. Such visits will
have defined purposes and be scheduled reasonably in advance and shall be
subject to the confidentiality obligations herein.
4.6 FUNDING.
4.6.1 TECHNOLOGY ACCESS FEE. In consideration for the prior research
and development activities of VARIAGENICS and the disclosure to WATERS of all
know-how associated with such prior research and development, WATERS shall
make a non-refundable payment to VARIAGENICS of Three Million Dollars
($3,000,000) on the later of (i) Effective Date or (ii) the date the parties
receive notice that the waiting period under the HSR Act (as defined in
Section 14.7), including any extensions thereof, has expired.
4.6.2 ALLIANCE PROJECT FUNDING. Each Party shall fund its own
activities under the Alliance Program.
4.7 Warrant Issuance. In consideration of WATERS' prior research and
development activities, in the event VARIAGENICS completes an initial public
offering ("IPO") on or before August 31, 2000, VARIAGENICS will issue to WATERS
warrants to purchase a number of shares of VARIAGENICS Common Stock determined
by the following formula:
N = .15 ($7,500,000 DIVIDED BY P)
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Where N is the number of shares covered by the warrants, and
P is the price at which shares are offered to the public in the IPO ("IPO
Price")
Such warrants will be exercisable at a price equal to the IPO Price, will
be immediately exercisable on issuance and will be exercisable for a period of
five (5) years and will be in the form of Warrant attached hereto at Exhibit
4.7.
4.8 Records and Reports.
4.8.1 RECORD KEEPING. VARIAGENICS and WATERS shall each maintain
records in sufficient detail and in accordance with good laboratory practice and
as will properly reflect, and will document in a manner appropriate for purposes
of supporting the filing of potential patent applications and applications for
any required regulatory approvals of the sale of Products, all work done and
results achieved in the performance of the Alliance Program (including all data
in the form required under any applicable governmental regulations). Subject to
Article 10 hereof, VARIAGENICS and WATERS shall each have the right to inspect
and copy such records to the extent reasonably required for the performance of
its obligations under this Agreement and shall not use such records or
information except to the extent otherwise permitted by this Agreement.
4.8.2 TECHNICAL REPORTS. Each party shall keep the Alliance Steering
Committee fully informed about the status of the Alliance Program including,
without limitation, furnishing copies of all reports received pursuant to
sponsored research agreements which relate to the Alliance Program. In
particular, without limitation, each party shall (i) report to the Alliance
Steering Committee on its activities in reasonable detail;
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(ii) provide the other party with access to all technology and information
employed in or arising out of the Alliance Program solely for the purpose of
conducting their respective roles hereunder; (iii) provide the other party with
summaries of any regulatory filings filed during the Term of this Agreement by
it for Licensed Products and copies of essential correspondence with regulatory
authorities in the Territory; and (d) provide such other information concerning
the Alliance Program as the other party shall reasonably request.
5. ADDITIONAL OBLIGATIONS
5.1 VARIAGENICS OBLIGATIONS.
5.1.1 VARIAGENICS shall obtain and shall take all actions necessary to
maintain, at its own expense, any licenses from third parties, including without
limitation the licenses listed on Schedule 5.1.1 hereof, reasonably necessary to
develop, manufacture and commercialize the VARIAGENICS Technology in the
Pharmaceutical Development Field. All such rights licensed in by VARIAGENICS
shall be specified on Exhibit 5.1.1 hereto, as amended from time to time.
5.1.2 Subject to the confidentiality obligations set forth herein,
VARIAGENICS shall provide to the Alliance Steering Committee, upon reasonable
request, any material information regarding any of VARIAGENICS' agreements with
third parties which the Alliance Steering Committee deems useful.
5.1.3 VARIAGENICS shall use reasonable efforts to make all decisions
required of VARIAGENICS in a timely manner.
5.1.4 Subject to the confidentiality obligations set forth herein,
VARIAGENICS shall promptly disclose to WATERS
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
and the Alliance Steering Committee any intellectual property rights of third
parties of which it becomes aware which may materially affect the ability of
either party to perform its obligations hereunder or the attainment of the
objectives of the Alliance. Such disclosure shall be in such a manner as to
protect a claim of privilege for such communication.
5.2 WATERS OBLIGATIONS
5.2.1 WATERS shall obtain and shall take all actions necessary to
maintain, at its own expense, any licenses from third parties including without
limitation the licenses listed on Schedule 5.2.1 hereof, reasonably necessary to
develop, manufacture and commercialize the WATERS Technology in the
Pharmaceutical Development Field. All such rights licensed in by WATERS shall be
specified on Exhibit 5.2.1 hereto, as amended from time to time.
5.2.2 Subject to the confidentiality obligations set forth herein,
WATERS shall provide to the Alliance Steering Committee, upon reasonable
request, any material information regarding any of WATERS' agreements with third
parties which the Alliance Steering Committee deems useful.
5.2.3 WATERS shall use reasonable efforts to make all decisions
required of WATERS in a timely manner.
5.2.4 Subject to the confidentiality obligations set forth herein,
WATERS shall promptly disclose to VARIAGENICS and the Alliance Steering
Committee any intellectual property rights of third parties of which it becomes
aware which may materially affect the ability of either party to perform its
obligations hereunder or the attainment of the objectives of the
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Alliance. Such disclosure shall be in such a manner as to protect a claim of
privilege for such communication.
5.2.5 During the two (2) year period beginning on the Effective
Date, WATERS will supply to VARIAGENICS WATERS Proprietary De-salting Plates
as reasonably requested by VARIAGENICS, [ ] for VARIAGENICS' internal
research purposes only (and not for resale or commercial distribution). Such
WATERS Proprietary De-salting Plates will meet specifications set forth in
Schedule 1.18 and will be delivered within thirty (30) days of the request
therefor, provided, however, that WATERS will not be obligated to provide
more than [ ] WATERS Proprietary De-salting Plates per year. Thereafter,
WATERS will supply WATERS Proprietary De-salting Plates to VARIAGENICS at the
[ ].
5.2.6 In order to maximize the value of the Strategic Alliance,
WATERS agrees that, for two (2) years following the Effective Date, it
will not directly or indirectly supply WATERS Proprietary De-Salting Plates
or similar devices to entities who WATERS knows or has reason to believe will
resell such WATERS Proprietary De-salting Plates or similar devices for use
in genotyping or haplotyping. Without limiting the generality of the
foregoing sentence, for a period of two (2) years following the Effective
Date, WATERS will not supply WATERS Proprietary De-salting Plates or similar
devices to those entities listed on Schedule 5.2.6 for resale or
subdistribution to any third party; provided that WATERS may supply WATERS
Proprietary De-salting Plates or similar devices to such entities for their
internal use.
5.3 DUE DILIGENCE. Each party will apply commercially reasonable diligent
efforts to the performance of all aspects of its obligations under the Alliance
Program and the Marketing Plan and to bring Licensed Products into commercial
use as quickly as reasonably possible.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
5.4 U.S. MANUFACTURE. WATERS will manufacture in the United States all
NuCleave-TM- Reagents to be included in Licensed Products to be sold in the
United States.
6. LICENSE GRANT
6.1. Subject to Section 6.4, VARIAGENICS hereby grants to WATERS:
(a) the sole and exclusive right and license in the Territory under
VARIAGENICS Patent Rights; and
(b) the sole and exclusive right and license in the Territory under
the VARIAGENICS Technology;
in each case to make, have made, manufacture, use, have used, sell, have
sold, offer for sale, lease, import and have imported Licensed Products for
use in the Field. VARIAGENICS shall not make, have made, manufacture, use,
have used, sell, have sold, offer for sale, lease, import or have imported
NuCleave-TM- Reagents or similar reagents for use in the Field and will not
directly or indirectly supply NuCleave-TM- Reagents or similar reagents to
entities who VARIAGENICS knows or has reason to believe will resell such
NuCleave-TM- Reagents or similar reagents for use in the Field unless such
entities agree in writing not to resell such NuCleave-TM- Reagents or similar
reagents in the Field; provided, however, that such prohibition shall not
apply to Generation 3 NuCleave-TM- Technology after the period set forth in
Section 4.2A(c).
6.2 The licenses and sublicenses granted in Section 6.1 shall continue
unless terminated as set forth herein. Royalties shall be payable in connection
with such licenses and sublicenses
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
in accordance with Section 7.5 and, thereafter, such licenses and sublicenses
shall be deemed fully-paid up and royalty free.
6.3 No rights are granted hereunder (i) to develop or commercialize any
products or processes or to utilize any intellectual property rights of
VARIAGENICS or any other party other than as expressly provided above, (ii)
to develop or commercialize any product that embodies any VARIAGENICS
Technology outside the Field, or (iii) for WATERS to provide a laboratory or
genotyping or haplotyping service or (iv) to promote the sale of NuCleave-TM-
Kits outside the Pharmaceutical Development Field or for use on any mass
spectrometer system other than a NuCleave-TM- System.
6.4 WATERS shall use commercially reasonable diligent efforts to
develop, promote, market and sell Licensed Products in the Field and to meet
or cause to be met the market demand for the Licensed Products in the Field
throughout the Territory. WATERS will not promote the use of NuCleave-TM-
Kits outside the Pharmaceutical Development Field. Without limiting the
generality of the foregoing, WATERS will not sell NuCleave-TM- Kits to any
clinical laboratory, including without limitation, those listed on Schedule
6.4 as long as that certain Alliance Agreement dated August 2, 1999 between
VARIAGENICS and Covance, Inc. remains in effect.
6.4A Notwithstanding the provisions of Section 6.3 and Section 6.4
(first sentence), it is understood that WATERS may (i) elect to sell Licensed
Products in the Field (and outside the Pharmaceutical Development Field) and
for use on a mass spectrometer system other than a NuCleave-TM- System and
(ii) promote and market Licensed Products in the Field (and outside
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
the Pharmaceutical Development Field) and for use on a mass spectrometer
system other than a NuCleave-TM- System; PROVIDED, however, that WATERS shall
keep the ASC adequately informed of such sales, marketing and promotional
activities in the Field (and outside the Pharmaceutical Development Field)
and for use on a mass spectrometer system other than a NuCleave-TM- System.
It is further understood and agreed that with respect to such activities: (a)
WATERS shall expressly disclaim any warranty and any support obligations
under Sections 14.2 and 14.4 of this Agreement and (b) WATERS shall not
receive any indemnification under the provisions of Section 15.
6.5 WATERS shall have the right to grant sublicenses to all or any portion
of its rights under the license granted pursuant to Section 6.1 to any Affiliate
or sublicensee; provided, however, that WATERS shall remain obligated to ensure
compliance with the terms of this Agreement and the payment of royalty
obligations as set forth in Section 7, and provided further that names and
current addresses of all sublicensees and Affiliates of WATERS to which rights
hereunder have been extended by WATERS and copies of all sublicense agreements
shall be provided promptly to VARIAGENICS.
6.6 If, for any reason, this Agreement is terminated, any sublicense
granted at the time of such termination shall also terminate.
7. CONSIDERATION
7.1 MILESTONE PAYMENTS. WATERS shall pay VARIAGENICS the following
milestone payments within thirty (30) days of the achievement of the following
milestones:
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
EVENT MILESTONE PAYMENT
VARIAGENICS first delivery $500,000
of a NuCleave-TM- System to a third
party for use in the Field
First twelve (12) month period in which $1,000,000
Net Sales reach $[ ] million
First twelve (12) month period in which Net $2,500,000
Sales reach $[ ] million
7.2 ROYALTIES. (a) In consideration of the licenses granted hereunder, for
each sale of a Licensed Product by WATERS or an Affiliate or sublicensee, WATERS
shall pay to VARIAGENICS a royalty equal to a percentage of Net Sales from the
sale of such Licensed Product determined as follows:
ANNUAL NET SALES (CALENDAR YEAR) ROYALTY RATE
First $[ ] million of Net Sales [ %]
Net Sales over $[ ] million [ %]
WATERS shall be obligated to make only one royalty payment for each unit of
Licensed Products sold, regardless of the number of Valid Claims from any one or
more patents covering such Licensed Product.
(b) In the event WATERS is required to pay royalties on sales in any
country of any Licensed Product under a license to a third party patent
determined by the ASC to be necessary to include the NuCleave-TM- Reagents in
such Licensed Product for use on a NuCleave-TM- System in the Pharmaceutical
Development Field, then WATERS may deduct 40% of such royalty payable to the
third party from the royalty due to VARIAGENICS on a product-by-product and
country-by-country basis; provided however that such deduction shall not
reduce the royalty payable to VARIAGENICS for any Licensed Product in any
country by more than 40% of the amount which would otherwise be due for sales
of such Licensed Product in such country.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
7.3 REPORTS. WATERS shall report to WATERS the date of the first sale of a
Licensed Product in each country within twenty-five (25) days of such first
sale. Royalty payments shall become due and payable on the forty-fifth day after
each fiscal quarter end, which shall be approximately March 31, June 30,
September 30 and December 31 of each year and shall made to VARIAGENICS in
United States Dollars. Each payment shall be accompanied by a report summarizing
the total Licensed Product sales during the relevant three-month period and the
calculation of royalties due thereon pursuant to Section 7.2. Such reports shall
also include the following information:
(a) amount of each Licensed Product manufactured and sold by WATERS,
its Affiliates and Sublicensees on a country-by-country basis;
(b) total xxxxxxxx for Licensed Products sold by WATERS, its
Affiliates and Sublicensees on a country-by-country basis;
(c) allowable deductions hereunder; and
(d) total royalties due.
7.4 All royalties and milestone payments hereunder shall be payable in full
in the United States in United States Dollars, regardless of the countries in
which sales are made. For the purpose of computing Net Sales for which a
currency other than United States Dollars is received, such currency shall be
converted into United States dollars at the simple average of all
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Mondays' exchange rate for buying United States Dollars set forth in THE WALL
STREET JOURNAL for the applicable fiscal quarter.
7.5 WATERS shall pay royalties with respect to each Licensed Product on a
country by country basis (i) until the expiration or revocation or complete
rejection of the last to expire or to be revoked or to be completely rejected of
any VARIAGENICS Patent Right covering such Licensed Product in the country in
which the Licensed Product is manufactured or sold, or (ii) if no VARIAGENICS
Patent Right exists in the relevant country covering the manufacture, use or
sale of the relevant Licensed Product, until fifteen (15) years from the first
commercial sale of such Licensed Product in such country.
7.6 Royalties not paid within the time period set forth in Section 7.3
shall bear interest at a per annum rate two percent (2%) above the prime rate
reported in the WALL STREET JOURNAL for the due date, calculated from the due
date until paid in full.
8. ACCOUNTING RECORDS
8.1 WATERS, its Affiliates and Sublicensees shall keep for five (5) years
from the date of each payment of royalties complete and accurate records of
sales by WATERS and its Affiliates and sublicensees of each Licensed Product in
sufficient detail to allow the accruing royalties to be determined accurately.
VARIAGENICS shall have the right for a period of two (2) years after receiving
any report or statement with respect to royalties due and payable to appoint an
independent certified public accountant reasonably acceptable to WATERS to
inspect the relevant records of WATERS and its Affiliates and Sublicensees to
verify such report or statement. WATERS and its Affiliates and Sublicensees
shall each make its
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
records available for inspection by such independent certified public
accountant during regular business hours at such place or places where such
records are customarily kept, upon reasonable notice from VARIAGENICS, solely
to verify the accuracy of the reports and payments. Such inspection right
shall not be exercised more than once in any calendar year nor more than once
with respect to sales of Licensed Products in any given payment period.
VARIAGENICS agrees to hold in strict confidence all information concerning
royalty payments and reports, and all information learned in the course of
any audit or inspection, except to the extent necessary for VARIAGENICS to
reveal such information in order to enforce its rights under this Agreement
or if disclosure is required by law, regulation or judicial order. Any person
or entity conducting such audit or inspection must agree in writing with
VARIAGENICS to treat all records reviewed in the course of the audit or
inspection as the Confidential Information of WATERS under terms and
conditions no less restrictive than the terms contained in Section 10 of this
Agreement. The results of each inspection, if any, shall be binding on both
Parties. VARIAGENICS shall pay for such inspections, except that in the event
there is any upward adjustment in aggregate royalties payable for any year
shown by such inspection of more than [ ]percent [ %]of the
amount paid, WATERS shall pay for such inspection.
9. MARKETING
9.1 GENERAL. Although WATERS will be responsible for manufacture and sale
of Licensed Products, both parties will participate in developing the market for
Licensed Products pursuant to a marketing plan (the "Marketing Plan").
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
9.2 MARKETING PLANS. The first Marketing Plan shall be prepared by
VARIAGENICS and WATERS and approved by the Alliance Steering Committee as
promptly as practical after the Effective Date. Subsequent Marketing Plans shall
be prepared by VARIAGENICS and WATERS and approved by the Alliance Steering
Committee no later than sixty (60) days before the end of the prior year. Each
Annual Marketing Plan shall be in writing and shall set forth with reasonable
specificity marketing objectives and tasks to be performed by each of the
parties for the period covered by the Annual Marketing Plan. The decisions as to
how to perform the tasks assigned to VARIAGENICS and WATERS in any Annual
Marketing Plan shall be VARIAGENICS Decisions and WATERS Decisions,
respectively. The Alliance Steering Committee may make adjustments in the Annual
Marketing Plan at its biannual meetings or otherwise as it may determine. Each
Marketing Plan will:
(a) set forth a marketing and sales strategy;
(b) set forth the responsibilities of each party with respect to such
strategy;
(c) identify the resources to be committed by each party in order to
assure proper sales force staffing and training, marketing
material development, conference presentation and public
relations, target customer identification and prioritization, and
sales call strategy development and implementation; and
(d) require that any marketing materials used by either party will be
approved by both parties and will include the names and logos of
both parties.
9.3 TRADEMARK MATTERS
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
9.3.1 PRODUCT MARKING. Each NuCleave-TM- Kit, and each container of
NuCleave-TM- Reagents, will be marked with the trademark "NuCleave" in such
manner as the ASC shall determine and shall indicate that it is manufactured
by WATERS under license from VARIAGENICS. Each WATERS Proprietary De-salting
Plate shall be marked with WATERS' trademark.
9.3.2 LICENSE TO WATERS. VARIAGENICS grants to WATERS a worldwide
non-exclusive license to use the trademarks and service marks owned by or
licensed to VARIAGENICS and listed on Schedule 9.3.2 (the "VARIAGENICS
Trademarks")solely for the purpose of conducting the activities authorized under
this Agreement. VARIAGENICS shall take such actions as are reasonably required
to maintain the VARIAGENICS Trademarks in effect, and shall inform WATERS of any
changes in or additions to the VARIAGENICS Trademarks. All right, title and
interest to the VARIAGENICS Trademarks shall remain with VARIAGENICS and no
other license relating thereto is granted hereunder. Subject to the wind-down
rights set forth in Sections 13.2-13.3, upon any expiration or termination of
this Agreement, the license to WATERS to use the VARIAGENICS Trademarks shall
terminate, and WATERS shall take all necessary action and execute and deliver to
VARIAGENICS all necessary documents and instruments to remove WATERS as a
registered user and/or a recorded licensee of such VARIAGENICS Trademarks. Upon
request of VARIAGENICS, WATERS shall provide VARIAGENICS with a sample of all
product packaging and advertising that makes use of the VARIAGENICS Trademarks
for purposes of permitting VARIAGENICS to verify that WATERS's use of the
VARIAGENICS Trademarks is consistent with the provisions of Schedule 9.3.2.
WATERS shall not challenge, directly or indirectly, VARIAGENICS' rights in
respect of the Trademarks;
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
PROVIDED, that WATERS shall not waive its rights with respect to existing
trademarks owned by WATERS or trademarks that WATERS acquires during the term of
this Agreement, and WATERS shall not waive any rights with respect to the
protection of its trademarks. WATERS shall comply with the Trademark guidelines
set forth in Schedule 9.3.2. In the event that WATERS elects to adopt other
marks in addition to those required by Section 9.3.1 for use in the promotion,
marketing and sale of the Licensed Products then this Section 9.3.2 shall not
apply to WATERS' use of such other marks.
9.3.3 LICENSE TO VARIAGENICS. WATERS grants to VARIAGENICS a worldwide
non-exclusive license to use the trademarks and service marks owned by or
licensed to WATERS and listed on Schedule 9.3.3 (the "WATERS Trademarks") solely
for the purpose of advertising and promoting the Licensed Products and the
Alliance Program as authorized under this Agreement. WATERS shall take such
actions as are reasonably required to maintain the WATERS Trademarks in effect,
and shall inform VARIAGENICS of any changes in or additions to the WATERS
Trademarks. All right, title and interest to the WATERS Trademarks shall remain
with WATERS and no other license relating thereto is granted hereunder. Subject
to the wind-down rights set forth in Sections 13.2-13.3, upon any expiration or
termination of this Agreement, the license to VARIAGENICS to use the WATERS
Trademarks shall terminate, and VARIAGENICS shall take all necessary action and
execute and deliver to WATERS all necessary documents and instruments to remove
VARIAGENICS as a registered user and/or a recorded licensee of such WATERS
Trademarks. Upon request of WATERS, VARIAGENICS shall provide WATERS with a
sample of all advertising that makes use of the WATERS Trademarks for purposes
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
of permitting WATERS to verify that VARIAGENICS' use of the WATERS Trademarks is
consistent with the provisions of Schedule 9.3.3. VARIAGENICS shall not
challenge, directly or indirectly, WATERS's rights in respect of the Trademarks;
PROVIDED, that VARIAGENICS shall not waive its rights with respect to existing
trademarks owned by VARIAGENICS or trademarks that VARIAGENICS acquires during
the term of this Agreement, and VARIAGENICS shall not waive any rights with
respect to the protection of its trademarks. VARIAGENICS shall comply with the
Trademark guidelines set forth in Schedule 9.3.2. In the event that VARIAGENICS
elects to adopt other marks for use in the promotion, marketing and sale of the
Licensed Products then this Section 9.3.2 shall not apply to VARIAGENICS' use of
such other marks.
10. TREATMENT OF CONFIDENTIAL INFORMATION
10.1 CONFIDENTIALITY.
10.1.1 VARIAGENICS and WATERS each recognize that the other party's
Confidential Information constitutes highly valuable and proprietary
confidential information. VARIAGENICS and WATERS each agree that during the Term
of the Strategic Alliance and for ten (10) years thereafter but in no event for
less than twelve (12) years after the Effective Date, it will keep confidential,
and will cause its employees, consultants, Affiliates and licensees and
sublicensees to keep confidential, all Confidential Information of the other
party that is disclosed to it, or to any of its employees, consultants,
Affiliates and licensees and sublicensees, pursuant to or in connection with
this Agreement, except to the extent that disclosure is required in accordance
with the performance of this Agreement. Neither VARIAGENICS nor WATERS nor any
of their respective employees,
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
consultants, Affiliates and licensees and sublicensees shall use Confidential
Information of the other party for any purpose whatsoever except as expressly
permitted in this Agreement.
10.1.2 VARIAGENICS and WATERS each agree that any disclosure of the
other party's Confidential Information to any of its officers, employees,
consultants or agents or those of any of its Affiliates and licensees and
sublicensees shall be made only if and to the extent necessary to carry out its
rights and responsibilities under this Agreement, shall be limited to the
maximum extent possible consistent with such rights and responsibilities and
shall only be made to persons who are bound by written confidentiality
obligations to maintain the confidentiality thereof and not to use such
Confidential Information except as expressly permitted by this Agreement.
VARIAGENICS and WATERS each agree not to disclose the other party's Confidential
Information to any third parties under any circumstance without the prior
written approval from the other party (such approval not to be unreasonably
withheld), except as required in any application for regulatory approvals for
testing, manufacture or sale of a Licensed Product subject to this Agreement, or
as otherwise required by law, and except as otherwise expressly permitted by
this Agreement. Each party shall take such action, and shall cause its
Affiliates and licensees and sublicensees to take such action, to preserve the
confidentiality of each other's Confidential Information as it would customarily
take to preserve the confidentiality of its own Confidential Information, and in
no event, less than reasonable care. Each party, upon the other's request, will
return (or destroy and provide written confirmation of such destruction) all the
Confidential Information disclosed to it by the other party
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
pursuant to this Agreement, including all copies and extracts of documents and
all manifestations in whatever form, within sixty (60) days of the request
following the termination of this Agreement; provided that a party may retain
Confidential Information of the other party relating to any license or right to
use Technology which survives such termination and one copy of all other
Confidential Information may be retained in inactive archives solely for the
purpose of establishing the contents thereof.
10.1.3 VARIAGENICS and WATERS each represent that all of its employees
and the employees of its Affiliates, and any consultants to such party or its
Affiliates, participating in the Strategic Alliance's activities who shall have
access to Confidential Information of the other party are bound by written
obligations to maintain such information in confidence and not to use such
information except as expressly permitted herein. Each party agrees to enforce
confidentiality obligations to which its employees and consultants (and those of
its Affiliates) are obligated.
10.2 PUBLICITY. Neither party may disclose the terms of this Agreement
without the prior written consent of the Alliance Steering Committee; provided,
however, that either party may make such a disclosure to the extent required by
law. Such disclosure shall be on reasonable notice to the other party and after
taking all reasonable steps to maintain confidentiality. The parties, upon the
execution of this Agreement, will agree upon the text and the exact timing of an
initial public announcement relating to the transactions contemplated by this
Agreement as soon as possible after the Effective Date (such agreement not to be
unreasonably withheld or delayed). Thereafter, the parties will
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
agree on the text and the timing of any subsequent public announcements
regarding this Agreement or the transactions contemplated herein; provided that.
once any written statement is approved for disclosure by the Alliance Steering
Committee, either party may make subsequent public disclosure of the contents of
such statement without the further approval of the other party or the Alliance
Steering Committee. Any costs incurred for public relations in respect of the
Strategic Alliance shall be paid by the party incurring the expense.
10.3 LIMITATION ON DISCLOSURES. Notwithstanding any provision in this
Agreement, neither party shall be obligated hereunder to disclose to the other
party any information which it is prohibited from disclosing by law or under any
agreement with a third party.
10.4 PROHIBITION ON HIRING. Neither party shall, during the term of the
Strategic Alliance and for a period of one (1) year thereafter, hire or solicit
any person who was employed by the other party or its Affiliates during such
period, whether such person is hired as an employee or consultant, unless
authorized in writing by the other party, or unless such person has not been
employed by the other party for at least 12 months prior to his or her hiring or
solicitation. Notwithstanding the foregoing, neither party shall be restricted
from hiring an applicant for a position who has responded to an advertisement
directed to the public without any direct contact from the hiring party.
11. INTELLECTUAL PROPERTY RIGHTS
11.1 DISCLOSURE OF INVENTIONS.
11.1.1 NOTICE OF INVENTIONS. Each party shall promptly disclose to the
other, unless prohibited by the
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
provisions of any agreement with third parties, all inventions applicable to
the development, manufacture or use of NuCleave-TM- Kits for use in the
Pharmaceutical Development Field that are conceived, made, developed or
acquired in the course of carrying out the Alliance Program by employees or
consultants of either of them or their Affiliates, or any third party
performing sponsored research for either of the parties, alone or jointly
with employees or consultants of the other party or its Affiliates, except,
in the case of WATERS, any inventions applicable to instruments or
accessories that may be sold or distributed in conjunction with the NuCleave
Kits which shall not be required to be disclosed under this Section 11.1.1.
11.1.2 EXCHANGE OF DOCUMENTS. Upon reasonable request, VARIAGENICS and
WATERS shall also provide copies to the other of any Patent Rights or agreements
relating thereto existing as of the Effective Date or thereafter acquired from
third parties which such party believes are useful in the Alliance Program,
provided that each of VARIAGENICS and WATERS may redact portions of any such
Patent Rights or agreements relating thereto not relevant to the Alliance
Program, and further provided that all such documents shall be considered
Confidential Information.
11.1.3 THIRD PARTY CONSENTS. Each party shall, if necessary, use
commercially reasonable efforts to obtain the written consent of any third party
needed to furnish the information set forth in Section 11.1.1 and 11.1.2.
11.2 OWNERSHIP.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
11.2.1 VARIAGENICS INTELLECTUAL PROPERTY RIGHTS. VARIAGENICS shall have
sole and exclusive ownership of all right, title and interest on a worldwide
basis in and to any Technology (i) solely invented by VARIAGENICS without use of
WATERS Technology, whether or not in the conduct of the Alliance Program, or
(ii) acquired after the date hereof by VARIAGENICS (collectively, "VARIAGENICS
Program Technology"), with full rights to license or sublicense, subject to the
obligations to the Strategic Alliance in the Field as set forth herein. Without
limiting the foregoing, subject to the licenses granted hereunder, VARIAGENICS
shall be the sole owner of all Patent Rights, all trade secret rights, all
know-how and any other intellectual property rights in the VARIAGENICS Program
Technology, including the sole and exclusive right to exclude others from
making, using, selling, offering for sale or importing the VARIAGENICS Program
Technology or any products derived from any VARIAGENICS Program Technology.
11.2.2 WATERS INTELLECTUAL PROPERTY RIGHTS.
WATERS shall have sole and exclusive ownership of all right, title
and interest on a worldwide basis in and to any Technology (i) solely invented
by WATERS without use of VARIAGENICS Technology, whether or not in the conduct
of the Alliance Program, or (ii) or acquired after the date hereof by WATERS
(collectively, "WATERS Program Technology"), with full rights to license or
sublicense, subject to the obligations to the Strategic Alliance in the Field as
set forth herein. Without limiting the foregoing, subject to the licenses
granted hereunder, WATERS shall be the sole owner of all Patent Rights, all
trade secret rights, all know-how and any other intellectual property rights in
the WATERS Program Technology, including the
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
sole and exclusive right to exclude others from making, using, selling, offering
for sale or importing the WATERS Program Technology or any products derived from
any WATERS Program Technology.
11.2.3 JOINT TECHNOLOGY.
(a) VARIAGENICS shall have sole and exclusive ownership of all
Technology relating to NuCleave-TM- Reagents or
NuCleave-TM- Technology jointly invented in the Alliance
Program by both VARIAGENICS (and/or any party performing
sponsored research for VARIAGENICS) and WATERS (and/or any party
performing sponsored research for WATERS) or invented in the
Alliance Program by one party (or during any research sponsored
by such party) with the use of or based upon the Technology of
the other party (collectively, the "Joint NuCleave-TM-
Technology"), and shall exclusively own all Joint Patent Rights
with respect to Joint NuCleave-TM- Technology, subject to
license rights held by WATERS with respect to Licensed Products.
(b) WATERS shall have sole and exclusive ownership of all Technology
relating to WATERS Proprietary De-salting Plates jointly invented
in the Alliance Program by both WATERS (and/or any party
performing sponsored research for WATERS) and VARIAGENICS (and/or
any party performing sponsored research for VARIAGENICS) or
invented in the Alliance Program by one party (or during any
research sponsored by such party) with the use of
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
or based upon the Technology of the other party (collectively,
the "Joint De-salting Plate Technology"), and shall exclusively
own all Joint Patent Rights with respect to Joint De-salting
Plate Technology, subject to the research license rights held by
VARIAGENICS pursuant to Section 2.3 of this Agreement.
(c) Inventorship shall be determined by the Patent Coordinators in
accordance with United States law at the time of determination.
The Patent Coordinators shall also make the determination as to
whether an invention is Joint Technology. In case of a dispute
between the Patent Coordinators, the matter shall be referred to
the Alliance Steering Committee. All such determinations shall be
treated as Joint Decisions hereunder. If the Alliance Steering
Committee cannot resolve the dispute, it shall be resolved by
independent patent counsel, not otherwise engaged by either of
the parties, selected by the Patent Coordinators. Expenses of
such independent patent counsel shall be shared equally by the
parties.
11.2.4 VARIAGENICS RIGHTS OUTSIDE THE FIELD. Except with respect to
Licensed Products in the Field, VARIAGENICS shall have no obligations hereunder
to WATERS or to the Strategic Alliance with respect to VARIAGENICS Technology.
11.2.5 WATERS RIGHTS OUTSIDE THE FIELD. Except with respect to Licensed
Products in the Field, WATERS shall have no obligations hereunder to VARIAGENICS
or the Strategic Alliance with respect to WATERS Technology.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
11.3 PATENT COORDINATORS. VARIAGENICS and WATERS shall each appoint a
patent coordinator ("Patent Coordinator"), reasonably acceptable to the other
party, who shall serve as such party's primary liaison with the other party on
matters relating to patent filing, prosecution, maintenance and enforcement.
Each party may replace its Patent Coordinator at any time by notice in writing
to the other party. The initial Patent Coordinators shall be:
For VARIAGENICS: Xxxxxxx Xxxxx, Ph.D.
For WATERS: Xxxxxxx Xxxxxx
12. PROVISIONS CONCERNING THE FILING, PROSECUTION AND
MAINTENANCE OF PATENT RIGHTS
12.1 FILING OF PATENTS. Each party will be responsible for the filing
and prosecution at its own expense, in such countries as the responsible
party shall select, of patents on Technology solely owned by such party;
PROVIDED THAT the other party will have the opportunity to provide
substantive review and comment on any such prosecution solely as it relates
to claims relating to the development, manufacture or use of NuCleave-TM-
Kits for use in the Pharmaceutical Development Field. Portions of any
documents relating to any such prosecution not related to such claims may be
redacted by a party prior to provision to the other party.
Each party shall also promptly give notice to the other of the initiation
of any interference, opposition, reissue, re-examination or revocation
proceeding and the grant, lapse, revocation, surrender, invalidation or
abandonment of any Patent
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
Rights relevant to this Agreement for which it has responsibility.
12.2 LEGAL ACTION.
12.2.1 ACTUAL OR THREATENED INFRINGEMENT. Subject to any obligation to
a third party licensor of Technology or Patent Rights to a party with respect to
the subject matter hereof:
(a) In the event either party becomes aware of any possible
infringement or unauthorized possession, knowledge or use
relating to the use of NuCleave-TM- Kits in the Field of
any intellectual property which is the subject matter of this
agreement (collectively, an "Infringement"), that party shall
promptly notify the other party and provide it with full details
(an "Infringement Notice"). The parties shall promptly meet to
determine a course of action and whether the parties will jointly
prosecute the Infringement, and if so, the sharing of expenses.
If the parties do not agree otherwise:
(i) WATERS shall have the first right and option, but not the
obligation, to prosecute or prevent such Infringement of
Patent Rights owned by WATERS, but if WATERS does not
commence an action to prosecute, or otherwise take steps to
prevent or terminate such Infringement within one hundred
eighty (180) days
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
from any Infringement Notice, then VARIAGENICS shall have
the second right and option to take such action as
VARIAGENICS will consider appropriate to prosecute or
prevent such Infringement.
(ii) VARIAGENICS shall have the first right and option, but not
the obligation, to prosecute or prevent such Infringement of
Patent Rights owned by VARIAGENICS, but if VARIAGENICS does
not commence an action to prosecute, or otherwise take steps
to prevent or terminate such Infringement within one hundred
eighty (180) days from any Infringement Notice, then WATERS
shall have the second right and option to take such action
as WATERS will consider appropriate to prosecute or prevent
such Infringement.
Each party shall always have the right to be represented by counsel of its
own selection in any suit instituted under clause (i) or (ii) of this Section
12.2.1(a) by the other party for Infringement. If either party lacks standing
and the other party has standing to bring any such suit, action or proceeding,
then the party with the right to bring suit may do so in the name of the other
party. Each party shall bear the cost of any proceeding or suit brought by it
under this Section 12.2.1(a). All sums recovered in such suit or in its
settlement shall be first used to reimburse costs incurred by the party bringing
the suit, then to reimburse costs of the other party, and the balance shall be
retained by the party bringing the suit, unless the
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
parties have agreed to share the expenses of the suit, in which event any
recoveries shall be shared in proportion to the sharing of expenses.
(b) In any action under this Section 12.2.1, the parties shall fully
cooperate with and assist each other. If either party determines
that it is necessary or desirable for the other to join any such
suit, action or proceeding, the second party shall execute all
papers and perform such other acts as may be reasonably required
in the circumstances. No suit under Section 12.2.1(a) may be
settled by a party exercising its second right to take action
without the approval of the Alliance Steering Committee.
(c) In the event of Infringement of a party's patent rights not
within the scope of the preceding paragraphs, that party can
proceed on its own and other party shall have no rights with
respect to such Infringement.
12.3.2 DEFENSE OF CLAIMS. Subject to any obligation to a third party
licensor of Technology or Patent Rights to a party with respect to the subject
matter hereof, in the event that any action, suit or proceeding is brought
against VARIAGENICS or WATERS or any Affiliate, licensee or sublicensee of
either party alleging the infringement of the intellectual property rights of a
third party by reason of the discovery, development, manufacture, use, sale,
importation or offer for sale of a Licensed Product, the parties will cooperate
with each
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
other in the defense of any such suit, action or proceeding. Notwithstanding the
foregoing, each party shall have the option to assume control of the defense of
any action, suit or proceeding which principally relates to the use of such
party's own Technology. The parties will give each other prompt written notice
of the commencement of any such suit, action or proceeding or claim of
infringement and will furnish each other a copy of each communication relating
to the alleged infringement. Neither party shall compromise, litigate, settle or
otherwise dispose of any such suit, action or proceeding which involves the use
of the other's Technology or Patent Rights without the other party's advice and
prior consent, provided that the party not defending the suit shall not
unreasonably withhold its consent to any settlement which does not have a
material adverse effect on its business. If the defending party determines that
the other party should institute or join any suit, action or proceeding pursuant
to this Section, the defending party may at its expense, join the other party as
a party to the suit, action or proceeding, and the party so joined shall execute
all documents and take all other actions, including giving testimony, which may
reasonably be required in connection with the prosecution of such suit, action
or proceeding. To the extent that the allegation of infringement is based
principally on the use of VARIAGENICS Technology or Joint Technology owned by
VARIAGENICS, the expenses of defense of the suit and any damages shall be borne
by VARIAGENICS and VARIAGENICS shall retain all recoveries. To the extent that
the allegation of infringement is based principally on the use of WATERS
Technology or Joint Technology owned by WATERS, the expenses of the suit and any
damages shall be borne by WATERS and WATERS shall retain all recoveries. To the
extent that the
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
allegation of infringement is based principally on the use of Joint Technology,
or to the extent that the allegation of infringement is not based principally on
the use of either WATERS Technology or VARIAGENICS Technology or Joint
Technology owned by one of them, such expenses shall be borne equally by the
parties, and the party that incurs such expenses shall xxxx the other party for
its share of the expenses on a timely basis, but in any event not less
frequently than quarterly, and all recoveries shall be shared equally by the
parties. In the event of any such action, suit or proceeding by a third party
claiming that the discovery, development, manufacture, use or sale of a product
infringes such third party's intellectual property rights, the parties shall
examine and discuss in good faith the consequences of such prohibition or
restriction or other conditions on this agreement and on possible modifications
thereto.
13. TERMINATION AND DISENGAGEMENT
13.1 TERM. This Agreement shall take effect as of the Effective Date and
shall continue until the (i) the expiration of the last-to-expire of the
VARIAGENICS Patent Rights or (ii) fifteen (15) years from the first commercial
sale of the Licensed Products in the last country in which sales of Licensed
Products are made (if the Licensed Products do not embody any VARIAGENICS Patent
Rights), whichever is later, unless sooner terminated in accordance with the
provisions of this Article 13.
13.2 TERMINATION.
13.2.1 INITIAL TERMINATION CONDITIONS. The Agreement may be terminated
in the following ways:
(i) by mutual consent of VARIAGENICS and WATERS;
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(ii) by one party upon written notice in the event that (a) the other
party shall have dissolved, ceased active business operations or
liquidated, unless such dissolution, cessation or liquidation
results from reorganization, acquisition, merger or similar
event, or (b) bankruptcy or insolvency proceedings, including any
proceeding under Title 11 of the United States Code, have been
brought by or against the other party and, in the event such a
proceeding has been brought against such party, remains
undismissed for a period of sixty (60) days, or an assignment has
been made for the benefit of such party's creditors or a receiver
of such party's assets has been appointed (a "Bankruptcy Event");
(iii)by one party upon default of the other party in the full and
timely observance or performance of its material covenants or
obligations under this Agreement, upon thirty (30) days prior
written notice in the case of a payment breach and sixty (60)
days' prior written notice in the case of any other such breach
by the other party, which notice shall specify the nature of the
default and the steps to be taken to cure such default; provided,
however, that if such default is cured by the defaulting party
within such thirty (30) or sixty (60) day period, such notice of
termination shall be deemed null and void as if the same had
never been given and this Agreement shall not be terminated
pursuant thereto;
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(iv) Upon 120 days written notice given at least two years after
the Effective Date unilaterally by WATERS in its sole
discretion, provided that WATERS shall be obligated to
supply to VARIAGENICS all Licensed Products then being sold
by WATERS for a period of the shorter of (a) one year
following the date of termination or (b) such time as
VARIAGENICS notifies WATERS that it has obtained a
satisfactory alternate source of supply. WATERS shall
supply such Licensed Products at a price equal to its
published U.S. List Price minus 40%. After such one year
period, WATERS shall supply WATERS Proprietary De-salting
Plates to VARIAGENICS at a price equal to the most
favorable pricing provided to any OEM customer (the "Supply
Price"). If WATERS ceases to manufacture WATERS Proprietary
De-salting Plates, then WATERS shall grant VARIAGENICS a
worldwide royalty bearing license under WATERS Technology
and WATERS Patent Rights to develop, have developed, make,
have made, use, have used, offer for sale, sell, have sold,
import and have imported WATERS Proprietary De-salting
Plates for use in the Field. The royalty under such license
shall be 40% of the Supply Price. All orders for Licensed
Products shall be placed by VARIAGENICS on written purchase
orders and shall be shipped by WATERS FOB place of
manufacture at such time, in such packaging and by such
means as the parties may mutually agree upon. WATERS shall
manufacture all such Licensed Products in the same
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
facility, and using the same processes and procedures, as it
was using prior to termination. In addition WATERS shall
furnish to VARIAGENICS copies of all information pertaining
to sales of Licensed Products and all information pertaining
to customers for Licensed Products and shall take all
reasonable steps to facilitate the transfer of such
customers to VARIAGENICS.
13.3 In the event of the termination of this Agreement for any reason,
WATERS shall cease sales of Licensed Products except sales to VARIAGENICS as set
forth in Section 13.2(iv) and all rights and interests in and to the VARIAGENICS
Patent Rights and VARIAGENICS Technology shall revert entirely to VARIAGENICS.
Without limiting the generality of the foregoing, WATERS shall promptly transfer
to VARIAGENICS all documents, materials and records in its possession embodying
or describing any VARIAGENICS Technology without retaining any copies thereof.
In addition, upon any termination of this Agreement for any reason, all rights
and interests in and to the WATERS Patent Rights and WATERS Technology shall
revert entirely to WATERS.
13.4 In the event of termination of this Agreement by VARIAGENICS
pursuant to Section 13.2.1(ii) or 13.2.1(iii) or by WATERS pursuant to
Section 13.2.1(iv), WATERS will provide VARIAGENICS with process information
concerning the large scale manufacture of NuCleave-TM- Reagents and shall
grant to VARIAGENICS the right to use such information to manufacture or have
manufactured such NuCleave-TM- Reagents.
13.5 The parties shall remain liable for all obligations accruing prior to
termination, including without limitation any
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
milestone payment with respect to any milestone achieved prior to termination.
13.6 If either Party shall fail to perform or observe or otherwise breaches
any of its material obligations under this Agreement, in addition to any right
to terminate this Agreement, the non-defaulting Party may elect to obtain other
relief and remedies available under law.
13.7 Notwithstanding any provision herein to the contrary, the rights and
obligations set forth in Sections 1, 7.1 (solely to the extent provided under
Section 13.5), 7.2 (solely to the extent provided under Section 13.5), 7.3, 7.4,
7.6, 8, 10, 11.2, 13.2(iv), 13.3-13.7, 14.1-14.3 and 15-17 hereof shall survive
the expiration or termination of this Agreement.
14. REPRESENTATIONS, WARRANTIES AND COVENANTS
14.1 MUTUAL REPRESENTATIONS. VARIAGENICS and WATERS each represents and
warrants to the other as follows:
14.1.1 ORGANIZATION. It is a corporation duly organized, validly
existing and is in good standing under the laws of the jurisdiction of its
incorporation, is qualified to do business and is in good standing as a foreign
corporation in each jurisdiction in which the performance of its obligations
hereunder requires such qualification and has all requisite power and authority,
corporate or otherwise, to conduct its business as now being conducted, to own,
lease and operate its properties and to execute, deliver and perform this
Agreement.
14.1.2 AUTHORIZATION. The execution, delivery and performance by it of
this Agreement have been duly authorized by all necessary corporate action and
do not and will not
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(a) require any consent or approval of its stockholders or (b) violate any
provision of any agreement, law, rule, regulation, order, writ, judgment,
injunction, decree, determination or award presently in effect having
applicability to it or any provision of its charter documents.
14.1.3 BINDING AGREEMENT. This Agreement is a legal, valid and binding
obligation of it enforceable against it in accordance with its terms and
conditions.
14.1.4 NO INCONSISTENT OBLIGATION. It is not under any obligation to
any person, or entity, contractual or otherwise, that is conflicting or
inconsistent in any respect with the terms of this Agreement or that would
impede the diligent and complete fulfillment of its obligations hereunder and
that it has all power and authority under all instruments or agreements to which
it is a party to enter into this Agreement and to perform its obligations
hereunder. Without limiting the generality of the foregoing, it has not granted
to any third party any rights to its Technology in the Field that are
inconsistent with this Agreement.
14.2 VARIAGENICS WARRANTY. VARIAGENICS warrants that the NuCleave-TM-
Reagents, if properly manufactured in accordance with specifications mutually
agreed upon by VARIAGENICS and WATERS as set forth on Schedule 14.2 hereto
(the "Specifications") and used in the Pharmaceutical Development Field in
accordance with proper procedures on a NuCleave-TM- System, will identify
genetic variations as specified in the product literature accompanying the
Licensed Product. WATERS shall have the right to extend such warranty to
purchasers of NuCleave-TM- Kits for use on NuCleave-TM- Systems in the
Pharmaceutical Development Field.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
14.3 WATERS WARRANTY. WATERS warrants to VARIAGENICS and will warrant to
purchasers of NuCleave-TM- Kits that such NuCleave-TM- Kits will be
manufactured in accordance with the Specifications.
14.4 NUCLEAVE-TM- SYSTEM SUPPORT. VARIAGENICS will be responsible
for service and support of NuCleave Kits for use on NuCleave-TM- Systems
for use in the Pharmaceutical Development Field. [ ].
14.5 CERTAIN LICENSED TECHNOLOGY. WATERS understands that US Patent
Application 09/214,207 which is part of the VARIAGENICS Patent Rights, has been
licensed from Harvard University by VARIAGENICS. The sublicense hereunder of
such patent application and any resulting patent or patents is subordinate to
the terms and conditions of the License Agreement between Harvard and
VARIAGENICS. In the event of termination of such License Agreement, VARIAGENICS'
interest in such sublicense will be assigned to Harvard; provided that Harvard
shall have no obligation as a result of such assignment except to keep the
sublicense in effect.
14.6 PATENT MARKING. WATERS will xxxx all Licensed Products with
appropriate patent marking.
14.7 XXXX-XXXXX-XXXXXX. The obligations of the parties to consummate the
transactions contemplated by this Agreement shall be subject to the expiration
of the applicable waiting period (including any extensions thereof) under the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended (the "HSR
Act"). Each party will as promptly as practicable file the required
notifications under the HSR Act and any documents required to be filed in
connection with such notifications and each party shall
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
request early termination of the waiting period specified under the HSR Act.
15. INDEMNIFICATION AND DISCLAIMERS
15.1A INFRINGEMENT INDEMNIFICATION. (a) Subject to the provisions of
Section 15.1C, VARIAGENICS shall defend, indemnify and hold harmless WATERS, its
subsidiaries, parent corporations, Affiliates, officers, directors, independent
contractors, partners, shareholders, employees, agents, successors and assigns
from and against any claim, suit, demand, loss, damage, expense (including
reasonable attorney's fees of indemnitee(s) and those that may be asserted by a
third party) or liability (collectively, "Losses") arising from or related to
any third party claim that use of the VARIAGENICS Technology in the Field in
accordance with the terms of this Agreement infringes any patent of any third
party. VARIAGENICS shall have no liability or obligation to WATERS under this
Section 15.1A(a) in the event and to the extent that the alleged infringement is
caused by: (i) use of the VARIAGENICS Technology in an application or on a
platform or with devices for which the VARIAGENICS Technology was not designed
or contemplated, or (ii) modifications, alterations, combinations or
enhancements of the VARIAGENICS Technology not created by VARIAGENICS. If any
VARIAGENICS Technology or its use is held to constitute an infringement of any
third party's patent or if in VARIAGENICS' opinion, any VARIAGENICS Technology
is, or is likely to be held to constitute, such an infringement, VARIAGENICS
will at its expense and option: (1) procure the right for WATERS to continue
using the VARIAGENICS Technology; (2) replace the VARIAGENICS Technology with
non-infringing equivalent technology conforming to the applicable
Specifications; or (3) modify the VARIAGENICS Technology to make it
non-infringing while
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
conforming to the applicable Specifications. If none of the foregoing options is
economically feasible, VARIAGENICS shall so notify WATERS and WATERS shall be
entitled to terminate this Agreement.
(b) Subject to the provisions of Section 15.1C, WATERS shall defend,
indemnify and hold harmless VARIAGENICS, its subsidiaries, parent corporations,
Affiliates, officers, directors, independent contractors, partners,
shareholders, employees, agents, successors and assigns from and against any
Losses arising from or related to any third party claim that use of the WATERS
Technology in the Field in accordance with the terms of this Agreement infringes
any patent of any third party. WATERS shall have no obligation or liability to
VARIAGENICS under this Section 15.1A(b) in the event and to the extent that the
alleged infringement is caused by the VARIAGENICS Technology or its use as
contemplated by this Agreement. If any WATERS Technology is held to constitute
an infringement of any third party's patent or if in WATERS' opinion, any WATERS
Technology is, or is likely to be held to constitute, such an infringement,
WATERS will at its expense and option: (1) replace the WATERS Technology with a
non-infringing equivalent technology conforming to the applicable
Specifications; or (2) modify the WATERS Technology to make it non-infringing
while conforming to the applicable Specifications. If none of the foregoing
options is economically feasible, WATERS shall so notify VARIAGENICS and
VARIAGENICS shall be entitled to terminate this Agreement.
15.1B OTHER INDEMNIFICATION CLAIMS.(a) Subject to the provisions of Section
15.1C, WATERS shall indemnify, defend and hold harmless VARIAGENICS, its
Affiliates and their respective
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
directors, officers, employees, and agents and their respective successors,
heirs and assigns (the "VARIAGENICS Indemnitees"), against any Losses arising
from or related to any third party claim arising out of or in connection with
(i) any material breach of WATERS' representations and warranties or covenants
under this Agreement; (ii) any negligence or intentional misconduct by WATERS
(or its employees, agents or representatives) in performing its obligations
under this Agreement; or (iii) personal injury and product liability matters,
arising out of the import, sale or use by any person of any Licensed Product
which is manufactured or sold by WATERS or by an Affiliate, licensee,
sublicensee, distributor or agent of WATERS. The foregoing indemnification
action shall not apply in the event and to the extent that a court of competent
jurisdiction determines that such Losses arose as a result of any VARIAGENICS
Indemnitee's negligence, intentional misconduct or breach of this Agreement.
(b) Subject to the provisions of Section 15.1C, VARIAGENICS shall
indemnify, defend and hold harmless WATERS, its Affiliates and their respective
directors, officers, employees, and agents and their respective successors,
heirs and assigns (the "WATERS Indemnitees"), against any liability, damage,
loss or expense (including reasonable attorneys' fees and expenses of
litigation) incurred by or imposed upon the WATERS Indemnitees, or any one of
them, in connection with any claims, suits, actions, demands or judgments of or
liabilities to third parties, arising out of or in connection with (i) any
material breach of VARIAGENICS' representations and warranties or covenants
under this Agreement; (ii) any negligence or intentional misconduct by
VARIAGENICS (or its employees, agents or representatives) in performing its
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
obligations under this Agreement; or (iii) personal injury and product liability
matters, arising out of the import, sale or use by any person of any Licensed
Product which is manufactured or sold by VARIAGENICS or by an Affiliate,
licensee, sublicensee, distributor or agent of VARIAGENICS. The foregoing
indemnification action shall not apply in the event and to the extent that a
court of competent jurisdiction determines that such Losses arose as a result of
any WATERS Indemnitee's negligence, intentional misconduct or breach of this
Agreement.
15.1C PROCEDURE. To receive the benefit of indemnification under Section
15.1A or Section 15.1B, the party seeking indemnification must promptly notify
the other party in writing of a claim or suit and provide reasonable cooperation
(at the indemnifying party's expense) and tender to the indemnifying party (and
its insurer) full authority to defend or settle the claim or suit, provided that
no settlement requiring any admission by the indemnified party or that imposes
any obligation on the indemnified party shall be made without the indemnified
party's consent. Neither party has any obligation to indemnify the other party
in connection with any settlement made without the indemnifying party's written
consent. The party seeking indemnification has the right to participate at its
own expense in the claim or suit and in selecting counsel therefor. The party
seeking indemnification shall cooperate with the indemnifying party (and its
insurer), as reasonably requested, at the indemnifying party's cost and expense.
15.1D INSURANCE. Each party shall procure and maintain product liability
insurance or self insure against product liability, adequate to cover its
obligations hereunder and
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
which are consistent with normal business practices of prudent companies
similarly situated at all times during the term of this Agreement. It is
understood that such insurance shall not be construed to create a limit of
either party's liability with respect to its indemnification obligations under
this Section 15. Each party shall provide the other with written evidence of
such insurance (or financial information that describes the amounts available
under any self-insurance facility) upon request. Each party shall provide the
other with written notice at least fifteen (15) days prior to the cancellation,
non-renewal or material change in such insurance or self-insurance which
materially adversely affects the rights of the other party hereunder. If such
party does not obtain replacement insurance or take other measures that allow it
to provide comparable coverage within such 15-day period, the other party shall
have the right to terminate this Agreement effective at the end of such fifteen
(15) day period without notice or any additional waiting periods.
15.2 WARRANTY DISCLAIMER. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS
AGREEMENT, NEITHER PARTY MAKES ANY WARRANTY WITH RESPECT TO ANY TECHNOLOGY,
GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY
DISCLAIMS WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE
AND NONINFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.
15.3 LIMITED LIABILITY. EXCEPT FOR BREACH OF CONFIDENTIALITY OBLIGATIONS
UNDER SECTION 10 AND Except AS OTHERWISE PROVIDED IN SECTION 15 WITH RESPECT TO
third party claims, NEITHER VARIAGENICS NOR WATERS WILL BE LIABLE WITH RESPECT
TO ANY SUBJECT MATTER OF THIS AGREEMENT UNDER ANY CONTRACT, NEGLIGENCE, STRICT
LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR (I) ANY
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
INDIRECT, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES OR LOST PROFITS OR (II)
COST OF PROCUREMENT OF SUBSTITUTE GOODS, TECHNOLOGY OR SERVICES, EXCEPT, IN THE
CASE OF THIS CLAUSE (II), IN THE EVENT OF A FAILURE TO SUPPLY BY WATERS PURSUANT
TO SECTION 13.2(iv).
16. DISPUTE RESOLUTION
16.1 DISPUTE RESOLUTION.
16.1.1 GENERAL. In the event of any dispute, difference or question
arising between the parties in connection with this Agreement, the construction
thereof, or the rights, duties or liabilities of either party, and which dispute
cannot be amicably resolved by the good faith efforts of the persons designated
under Section 3.7, then such dispute shall (i) be resolved by non-binding
mediation conducted in the manner set forth in Section 16.1.2, and (ii) in the
event that such dispute is not amicably resolved by such non-binding mediation,
then subject to mutual agreement of the parties the dispute may be referred to
binding arbitration as set forth in Section 16.1.3, provided, however, that
failure of the ASC to reach agreement on any matter shall not be subject to
arbitration under Section 16.1.3. In the event that the parties do not agree to
refer the matter to arbitration, the parties may resort to litigation.
16.1.2 MEDIATION. In the event of the occurrence of a dispute which
cannot be amicably resolved by the good faith efforts of the persons designated
under Section 3.7, either party may, by notice to the other party, commence a
non-binding mediation to resolve such dispute by providing written notice to the
other party, which notice (a "Mediation Notice") shall inform the other party of
such dispute and the issues to be resolved and
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
shall contain a list of five (5) recommended individuals to serve as the
mediator. Within ten (10) business days after the receipt of such Mediation
Notice, the other party shall respond by written notice to the party initiating
mediation, which notice shall contain a list of five (5) recommended individuals
to serve as the mediator and which may add additional issues to be resolved. The
recommended mediators shall be individuals with experience in the biotechnology
and/or pharmaceutical industry and shall not be an employee, director,
shareholder or agent of either party or of an Affiliate or subsidiary of either
party, or otherwise involved (whether by contract or otherwise) in the affairs
of either party. If, within twenty (20) business days after receipt of such
Mediation Notice, the parties shall have been unable to mutually agree upon an
individual to serve as a mediator, then such dispute (other than a failure of
the ASC to reach agreement on any matter) shall be settled by final and binding
arbitration conducted in the manner described in Section 16.1.3. If, within
twenty (20) business days after receipt of such Mediation Notice, the parties
shall have mutually agreed upon an individual to serve as a mediator, then the
mediator shall conduct a mediation in an effort to resolve such dispute as
follows:
(i) Within thirty (30) business days after selection, the
mediator shall hold a hearing to resolve each of the issues
identified by the parties. Each party shall be represented
at the hearing by up to two (2) employees of such party, one
of whom is an officer of such party, and may be represented
by counsel. The hearing shall be held in a mutually
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
agreeable location. No discovery will be conducted, unless
the parties otherwise mutually agree.
(ii) At least ten (10) business days prior to the date set for
the hearing, each party shall submit to the other party and
the mediator a proposed ruling on each issue to be resolved,
which writing (A) may, in addition to containing the
proposed rulings, contain arguments or analyses of the facts
or issues and (B) shall be limited to not more than twenty
(20) pages.
(iii)Each party shall be entitled to no more than three (3) hours
of hearing time to present oral testimony. The oral
testimony of both parties shall be presented during the same
calendar day. Such time limitation shall include any direct,
cross or rebuttal testimony, but such time limitation shall
only be charged against the party conducting such direct,
cross or rebuttal testimony. It shall be the responsibility
of the mediator to determine whether the parties have had
the presentation time to which they are entitled.
(iv) At the hearing, the mediator shall attempt to resolve each
issue in dispute between the parties. If the mediator shall
be unable to resolve any issue, the mediator shall provide
the parties with the mediator's non-binding
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
ruling on each such issue. The mediator shall, in rendering
his decision, apply the substantive law of the Commonwealth
of Massachusetts, without giving effect to its principles of
conflicts of law, and without giving effect to any rules or
laws relating to arbitration.
(v) If the mediator has not been able to resolve each issue,
each issue remaining in dispute (other than failures of the
ASC to reach agreement on any matter) shall be settled by
final and binding arbitration conducted in the manner
described in Section 16.1.3 below. At any such arbitration
or any subsequent legal proceeding, neither any rulings of
the mediator, any admissions or settlement offers made by
any party at the mediation nor any other information
disclosed at the mediation may be introduced into evidence.
The mediation proceeding shall be confidential. Except as
required by law, no party shall make (or instruct the
mediator to make) any public announcement with respect to
the proceedings or rulings of the mediator without the prior
written consent of each other party. The existence of any
dispute submitted to mediation, and the rulings of the
mediator, shall be kept in confidence by the parties and the
mediator, except as required by applicable law.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
(vi) Each party shall pay its own costs (including, without
limitation, attorneys fees) and expenses in connection with
such mediation. The fees and expenses of the mediator shall
be shared equally by the parties.
16.1.3 ARBITRATION. Binding arbitration shall be conducted in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association in Boston, Massachusetts. The arbitration panel shall be composed of
three arbitrators, one of whom shall be chosen by WATERS, one by VARIAGENICS and
the third by the two so chosen. The arbitrators shall each have experience in
the biotechnology or analytic reagent business and shall not be an employee,
director, shareholder or agent of either party or of an Affiliate or subsidiary
of either party, or otherwise involved (whether by contract or otherwise) in the
affairs of either party. If both or either of WATERS or VARIAGENICS fails to
choose an arbitrator or arbitrators within fourteen (14) days after receiving
notice of commencement of arbitration or if the two arbitrators fail to choose a
third arbitrator within fourteen (14) days after their appointment, the then
President of the Boston office of the American Arbitration Association shall,
upon the request of both or either of the parties to the arbitration, appoint
the arbitrator or arbitrators required to complete the board or, if he shall
decline or fail to do so, such arbitrator or arbitrators shall be appointed by
the President of the American Arbitration Association.
(i) EXCHANGE OF PROPOSALS. Within ten (10) days of the
appointment of the full arbitration panel, the parties shall
exchange documents setting forth
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
their final detailed proposals for resolution of the matter
in dispute, together with a brief or other written
memorandum supporting the merits of their final proposal.
The arbitration panel shall promptly convene a hearing, at
which time each party shall have an amount of time
determined by the arbitrators to argue and present witnesses
in support of its final proposal.
(ii) SELECTION OF FINAL PROPOSAL. The arbitration panel shall
select the proposal which most closely reflects a
commercially reasonable interpretation of the terms of this
Agreement as the way to resolve the matter. In making their
selection, the arbitrators shall not modify the terms or
conditions of either party's final proposal nor shall the
arbitrators combine provisions from both final proposals. In
making their selection, the arbitrators shall consider the
terms and conditions of this Agreement, the relative merits
of the final proposals, and the written and oral arguments
of the parties. In the event the arbitrators seek the
guidance of the law of any jurisdiction, the law of the
Commonwealth of Massachusetts shall govern.
(iii)NOTIFICATION OF DECISION. The arbitrators shall make their
decision known to both parties as quickly as possible by
delivering written notice of their decision to both parties.
The parties shall agree in writing to comply with the
proposal selected by the arbitration panel within five (5)
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
days of receipt of notice of such selection. The decision of
the arbitrators shall be final and binding on the parties,
and specific performance may be ordered by any court of
competent jurisdiction.
(iv) COSTS. The parties shall bear their own costs in preparing
for the arbitration. The costs of the arbitrators shall be
equally divided between the parties.
17. MISCELLANEOUS
17.1 NOTICES. All notices shall be in writing, mailed via, certified mail,
return receipt requested, courier providing evidence of delivery, or facsimile
transmission confirmed by hard copy given as aforesaid addressed as follows, or
to such other address as may be designated from time to time:
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
If to WATERS: WATERS TECHNOLOGIES CORPORATION
00 Xxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: President and Chief Executive
Officer
With a copy to: Xxxxxxx Xxxxxx, Esq.
WATERS TECHNOLOGIES CORPORATION
00 Xxxxx Xxxxxx
Xxxxxxx, XX 00000
If to VARIAGENICS: Variagenics, Inc.
00 Xxxxxxxxx Xxxxxx
Xxxxxxxxx, XX 00000-0000
Attn: President and Chief Executive Officer
With a copy to: Xxxxxxx X. Xxxxxx, Esq.
Mintz, Levin, Cohn, Ferris,
Glovsky and Popeo, P.C.
Xxx Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000
Notices shall be deemed given as of the date received.
17.2 GOVERNING LAW AND JURISDICTION. This Agreement shall be governed by
and construed in accordance with the laws of the Commonwealth of Massachusetts,
U.S.A., without regard to the application of principles of conflicts of law. Any
dispute concerning or action to enforce this Agreement shall be brought in
Massachusetts.
17.3 BINDING EFFECT. This Agreement shall be binding upon and inure to the
benefit of the parties and their respective legal representatives, successors
and permitted assigns.
17.4 HEADINGS. Section and subsection headings are inserted for convenience
of reference only and do not form a part of this Agreement.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
17.5 COUNTERPARTS. This Agreement may be executed simultaneously in two or
more counterparts, each of which shall be deemed an original.
17.6 AMENDMENT; WAIVER. This Agreement may be amended, modified, superseded
or canceled, and any of the terms may be waived, only by a written instrument
executed by each party or, in the case of waiver, by the party or parties
waiving compliance. The delay or failure of any party at any time or times to
require performance of any provisions shall in no manner affect the rights at a
later time to enforce the same. No waiver by any party of any condition or of
the breach of any term contained in this Agreement, whether by conduct, or
otherwise, in any one or more instances, shall be deemed to be, or considered
as, a further or continuing waiver of any such condition or of the breach of
such term or any other term of this Agreement.
17.7 NO THIRD PARTY BENEFICIARIES. Except as set forth in Article 15
hereof, no third party including any employee of any party to this Agreement,
shall have or acquire any rights by reason of this Agreement.
17.8 ASSIGNMENT AND SUCCESSORS. Neither this Agreement nor any obligation
of a party hereunder may be assigned by either party without the consent of the
other, which shall not be unreasonably withheld, except that each party may
assign this Agreement and the rights, obligations and interests of such party,
in whole or in part, to any of its Affiliates, to any purchaser of all or
substantially all of its assets or to any successor corporation resulting from
any merger or consolidation of such party with or into such corporations.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
17.9 FORCE MAJEURE. Neither WATERS nor VARIAGENICS shall be liable for
failure of or delay in performing obligations set forth in this Agreement, and
neither shall be deemed in breach of its obligations, if such failure or delay
is due to natural disasters or any causes beyond the reasonable control of
WATERS or VARIAGENICS. In event of such force majeure, the party affected
thereby shall use reasonable efforts to cure or overcome the same and resume
performance of its obligations hereunder.
17.10 INTERPRETATION. The parties hereto acknowledge and agree that: (i)
each party and its counsel reviewed and negotiated the terms and provisions of
this Agreement and have contributed to its revision; (ii) the rule of
construction to the effect that any ambiguities are resolved against the
drafting party shall not be employed in the interpretation of this Agreement;
and (iii) the terms and provisions of this Agreement shall be construed fairly
as to all parties hereto and not in a favor of or against any party, regardless
of which party was generally responsible for the preparation of this Agreement.
17.11 INTEGRATION; SEVERABILITY. This Agreement (including the Exhibits and
Schedules hereto) is the sole agreement with respect to the subject matter
hereof and supersedes all other agreements and understandings between the
parties with respect to same. If any provision of this Agreement is or becomes
invalid or is ruled invalid by any court of competent jurisdiction or is deemed
unenforceable, it is the intention of the parties that the remainder of the
Agreement shall not be affected.
17.12 FURTHER ASSURANCES. Each of VARIAGENICS and WATERS agrees to duly
execute and deliver, or cause to be duly
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
executed and delivered, such further instruments and do and cause to be done
such further acts and things, including, without limitation, the filing of such
additional assignments, agreements, documents and instruments, that may be
necessary or as the other party hereto may at any time and from time to time
reasonably request in connection with this Agreement or to carry out more
effectively the provisions and purposes of, or to better assure and confirm unto
such other party its rights and remedies under, this Agreement.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed
by their duly authorized representatives.
WATERS TECHNOLOGIES CORPORATION
By: /s/ Xxxxxx X. Xxxxxx
-------------------------------
Title: Chief Financial Officer
-------------------------------
Date: June 21, 2000
-------------------------------
VARIAGENICS, INC.
By: /s/ Xxxxxx X Xxxxxx
-------------------------------
Title: Chief Executive Officer
-------------------------------
Date: June 21, 2000
-------------------------------
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 1.15
NUCLEAVE-TM- REAGENTS
1. One or more modified deoxyribonucleotide triphosphates selected from
the group consisting of [ ].
2. Mixtures or single deoxyribonucleotide triphosphates [ ]
3. Cleaving chemicals consisting of single components or mixtures of
[ ] or components yet to be defined for specific
[ ] listed in item 1.
4. WATERS Proprietary De-salting Plate conditioning and elution reagents
consisting of [ ]
5. Other reagents that are necessary to run the NuCleave-TM- genotyping
or haplotyping assay will be supplied by the customer and include DNA
template, specific deoxyribonucleotide primers, thermostable Taq polymerase
and mass spectrometer matrix.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 1.19A
VARIAGENICS PATENT RIGHTS
U.S. patent application serial number 09-394,467 entitled "A Method for
Analyzing Polynucleotides"
U.S. patent application serial number 09-394,457 entitled "A Method for
Analyzing Polynucleotides"
U.S. patent application serial number 09-394,774 entitled "A Method for
Analyzing Polynucleotides"
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 1.19B
WATERS PATENT RIGHTS
United States Patent 5,882,521 "Water Wettable Chromatographic
Media for Solid Phase Extraction"
United States Patent 5,976,367 "Water Wettable Chromatographic
Media for Solid Phase Extraction"
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 1.33A
SPECIFICATIONS FOR WATERS PROPRIETARY DE-SALTING PLATE
To determined by the ASC
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 4.2
INITIAL NUCLEAVE-TM- KIT
1. Two modified deoxyribonucleotide triphosphates [ ]
supplied in a buffered solution at concentrations and volumes sufficient to
run [ ] reactions.
2. Two mixtures of [ ], the first comprised of
[ ] to be used with [ ]and the second comprised
of [ ] to be used with [ ]reactions.
3. Cleaving chemicals consisting of [ ].
4. WATERS Proprietary De-salting Plate conditioning and elution reagents
consisting of [ ].
5. Waters 384 well WATERS Proprietary De-salting Plate for use in
NuCleave-TM- genotyping and haplotyping reactions.
6. 384 well elution plate to be used with the 384 well WATERS
Proprietary De-salting Plate to collect the purified NuCleave-TM- genotyping
and haplotyping reactions.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 5.1.1
VARIAGENICS LICENSES
License Agreement effective June 15, 2000, as amended, between the President
and Fellows of Harvard College and Variagenics, Inc.
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 5.2.1
WATERS LICENSES
None
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 5.2.6
CERTAIN COMPANIES
[ ]
[ ]
[ ]
[ ]
[ ]
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 6.4
CERTAIN CLINICAL LABORATORIES
Quintiles Transnational Corporation
Parexel International
PPD Inc.
Quest Diagnostics
Lab Corp.
Viromed
Specialty Laboratories
National Genetics Institute
Consolidated Laboratories
SmithKline Xxxxxxx Clinical Labs
Mayo Clinic
MediLab
UCT
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 9.3.2
VARIAGENICS TRADEMARKS
NuCleave-TM-
VARIAGENICS-TM-
Portions of this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company's application requesting
confidential treatment under Rule 406 of the Securities Act.
SCHEDULE 9.3.3
WATERS TRADEMARKS
WATERS-TM-
