EXHIBIT 10.1
CONFIDENTIAL TREATMENT
AGREEMENT
This Agreement, dated as of July 30, 2001, (the "Effective Date") is by
and, between Albany Molecular Research, Inc., a Delaware corporation, located at
00 Xxxxxxxxx Xxxxxx, X.X. Xxx 00000, Xxxxxx, Xxx Xxxx 00000 ("AMRI"), and CUBIST
Pharmaceuticals, Inc., a Delaware corporation with a place of business at 00
Xxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxxxxxx 00000 ("CUBIST").
NOW, THEREFORE, in consideration of the mutual promises and other good and
valuable consideration, the parties agree as follows:
SECTION 1. - Definitions.
The terms used in this Agreement have the following meaning:
1.1 "AFFILIATE" with respect to any Party, shall mean any Person whether
de jure or de facto, controlling, controlled by, or under common control with,
such Party. For these purposes, "control" shall refer to (a) the possession,
directly or indirectly, of the power to direct the management or policies of a
Person, whether through the ownership of voting securities, by contract or
otherwise or (b) the ownership, directly or indirectly, of at least 50% (or such
lesser percentage which is the maximum allowed to be owned by a foreign
corporation in a particular jurisdiction of the voting securities or other
ownership interest of a Person).
1.2 "AMRI BACKGROUND PATENTS" means claims of any and all patents and
patent applications [*] that are owned by AMRI as of the Effective Date and that
claim a [*] that was used by AMRI in producing AMRI Derivatives pursuant to the
Research Program.
1.3 "AMRI DERIVATIVE" means (i) a compound(s) prepared by AMRI pursuant to
the Research Program and that is either a derivative of [*] developed or
practiced by AMRI, or a derivative of any such [*] developed or practiced by
AMRI, and/or (ii) compound(s) prepared by CUBIST or its Affiliates or
Sublicensees that are [*] in (i).
1.4 "AMRI PROCESS TECHNOLOGY" means the data, know-how and information
that is required to produce [*] used by AMRI in the Research Program, whether
patented or not.
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1.5 "[*] PROCESS" means [*] procedure or [*] used by AMRI to prepare
derivatives of [*] and, without limitation, any process or procedure using [*]
under this Agreement.
1.6 "COMBINATION PRODUCT" shall mean a CUBIST Product that includes an
AMRI Derivative or a CUBIST Derivative and one or more additional active agents.
1.7 "CUBIST DERIVATIVE" means a compound prepared by CUBIST or its
Affiliates or Sublicensees or any of their agents, consultants or collaborators
that is directly based upon or directly derived from an AMRI Derivative.
1.8 "CUBIST PRODUCT" means either an
(a) "AMRI Derivative Product" which is a product (i) the making, using, selling,
offering for sale, or import of which would, but for the licenses granted
herein, infringe a valid claim of a Research Patent or (ii) that includes an
AMRI Derivative; or
(b) "CUBIST Derivative Product" which is a product containing a CUBIST
Derivative.
1.9 "FDA" means the United States Food and Drug Administration, or the
successor thereto.
1.10 "FTE" means a full time equivalent person year of scientific or
technical work, working forty hours per week for at least 48 weeks.
1.11 "FIRST COMMERCIAL SALE" means, with respect to any CUBIST Product in
a country of the Territory, the first sale of a CUBIST Product by CUBIST, its
Affiliates, distributors or Sublicensees to a Third Party, in such country
anywhere in the Territory, after all required marketing and pricing approvals
have been granted, or otherwise permitted, by the governing health authority of
such country. "First Commercial Sale" shall not include the sale of any CUBIST
Product for use in clinical trials or for compassionate use prior to the grant
of regulatory approval.
1.12 "IND" shall mean an investigational new drug application filed with
the FDA for approval to commence human clinical trials, or the equivalent
application in other countries or regulatory jurisdictions.
1.13 "MAJOR MARKETS" means the [*].
1.14 "NET SALES" means, with respect to any CUBIST Product, the gross
amount received by CUBIST, its Affiliates, Sublicensees, distributors
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or co-marketers for sale of CUBIST Product to an independent Third Party in a
bona fide arms length transaction less deductions for: (i) trade, quantity
and/or cash discounts, allowances and rebates actually allowed or given; (ii)
freight, shipping, insurance and other transportation expenses (if separately
identified in such invoice); (iii) credits or refunds actually allowed for
rejections, or defects of such CUBIST Product, outdated or returned CUBIST
Product, or because of rebates or retroactive price reductions; and (iv) sales,
value-added, excise taxes, tariffs and duties, and other taxes directly related
to the sale and except for excise taxes, only to the extent that such items are
separately identified in such invoice. If a CUBIST Product is a Combination
Product, then Net Sales shall be calculated by multiplying the actual Net Sales
of such Combination Product by the fraction A/(A+B) where A is the invoice price
of the AMRI Derivative or CUBIST Derivative if sold separately, and B is the
total invoice price of the other active ingredient or ingredients in the
combination, if sold separately. If, on a country-by-country basis, the other
active ingredient or ingredients in the combination are not sold separately in
said country, Net Sales for the purpose of determining royalties of the
combination product shall be calculated by multiplying actual Net Sales of such
combination product by the fraction A/C where A is the invoice price of the AMRI
Derivative or CUBIST Derivative if sold separately, and C is the invoice price
of the combination product.
1.15 "PARTY" means AMRI or CUBIST and, when used in the plural, means AMRI
and CUBIST.
1.16 "PERSON" means any natural person, corporation, firm, business trust,
joint venture, association, organization, company, partnership or other business
entity, or any government or any agency or political subdivision thereof.
1.17 "RESEARCH PATENTS" means any and all patents or patent applications
that are invented by an employee(s) of AMRI pursuant to the Research Program
(alone or jointly with an employee of CUBIST) and claim AMRI Process Technology,
AMRI Derivatives, or the use thereof.
1.18 "RESEARCH PLANS" means the plans for Stage I Research and Stage II
Research attached as Appendix A.
1.19 "RESEARCH PROGRAM" means research performed by the Parties pursuant
to the Research Plans.
1.20 "ROYALTY TERM" means, with respect to each CUBIST Product in each
country in the Territory the period of time commencing on the Effective
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Date in such country and ending on the later of (i) [*] from the date of the
First Commercial Sale of such CUBIST Product in such country, or (ii) the date
on which the CUBIST Product in the country where manufactured, used, sold or
offered for sale no longer infringes (a) a Valid Claim of a Research Patent or
(b) a Valid Claim of an AMRI Background Patent but for the licenses granted
herein.
1.21. "STAGE I RESEARCH PLAN" means the stage I research as described in
the plan attached as Appendix A and any amendment thereto agreed to in writing
by the Parties.
1.22 "STAGE II RESEARCH PLAN" means the stage II research as described in
the plan attached as Appendix A and any amendment thereto agreed to in writing
by the Parties.
1.23 "SUBLICENSEE" shall mean a Third Party to which CUBIST has granted a
license and/or sub-sublicense rights under the licenses granted to CUBIST
hereunder.
1.24 "THIRD PARTY" means any Person who or which is neither a Party nor,
with respect to a Party, an Affiliate of that Party.
1.25 "VALID CLAIM" means (i) any claim of a pending patent application
which has not been pending for more than [*] and/or (ii) any claim of an
unexpired patent which has not been held unenforceable or invalid by a decision
of a court or other government agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which has not been
disclaimed, denied or admitted to be invalid or unenforceable through reissue or
disclaimer or otherwise.
2. RESEARCH PROGRAM
2.1 STEERING COMMITTEE. Within [*] after the Effective Date, the Parties
shall form a Steering Committee for the Research Program. The Steering Committee
shall consist of [*] representatives of each Party and shall be responsible for
ensuring that the research plan is consistent with the goals and objectives of
the Research Program. The operation and authority of the Steering Committee
shall be as follows:
(a) RESEARCH PROGRAM. The Steering Committee shall have general
authority over [*] and [*] of the Research Program. The Steering Committee shall
periodically review the Research Program from a strategic perspective and make
changes as it deems necessary to accomplish the purpose of the overall Research
Program.
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(b) REVIEW OF ACTIVITIES. The Steering Committee shall periodically
review the results of the Research Program to ensure, to the extent reasonably
practical, that the Parties are meeting their commitments for both human and
financial support for the fulfillment of all contractual obligations between the
Parties.
(c) REPRESENTATION. AMRI and CUBIST shall each appoint a minimum of
[*] representatives to serve on the Steering Committee. The representatives of a
Party may be changed from time to time at the discretion of that Party upon
written notification by the Party making such change to the other.
(d) MEETINGS. The Steering Committee shall meet from time to time as
determined by the Steering Committee members. It is expected that the Steering
Committee shall meet in person at least [*] in each calendar year. The location
of Steering Committee meetings shall alternate between AMRI's and CUBIST's
offices unless otherwise agreed by the Parties, with the first meeting being
held at a CUBIST office. Consultants and non-representative employees of the
Parties may attend meetings of the Steering Committee as required to further the
Research Program. Minutes of all meetings setting forth decisions of the
Steering Committee relative to the Research Program will be prepared and
circulated by the Party hosting the meeting within [*] of such meeting. Such
minutes will become official when agreed to by all members of the Steering
Committee. Each Party will bear all expenses associated with attendance of its
employees and consultants at such meetings. If the Steering Committee members
all agree, a meeting may be held by means of telephone conference or similar
communications equipment by means of which all persons participating in the
meeting can hear each other. A quorum for a meeting shall require [*] of AMRI
and [*] of CUBIST.
(e) DECISIONS. CUBIST will define the goals and objectives of the
program, and shall have the right to change the goals and objectives at any time
during the tern of this Agreement, provided such changes are put in writing and
provided to the Steering Committee. The Steering Committee shall make decisions
about the ways to technically achieve such goals and objectives, preferably by a
unanimous vote, with the representatives of each Party having one collective
vote. If a dispute arises, it shall be referred to the [*] of AMRI (or successor
position), and the [*] of CUBIST (or successor position) for further discussion
and resolution. These individuals shall, as soon as practicable, attempt in good
faith to resolve the dispute and, thereby, make the decision on behalf of the
Steering Committee. These individuals may obtain the advice of other employees
as they deem necessary or advisable in order to make the decision. If such
dispute is not resolved within
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[*] days after it has been referred to such persons for resolution, the dispute
shall be referred to CUBIST's [*] (or the applicable successor thereof), who
shall make the final decision regarding such dispute in good faith.
2.2 AMRI shall perform research in accordance with the Stage I Research
Plan. The research for the Stage I Research Plan shall be performed over a [*]
period at a total cost of not more [*], which shall be paid in [*] equal [*]
installments, provided Stage 1 is not terminated prior to the completion of the
[*] period. The [*] installment shall be paid within [*] days of the Effective
Date, and each subsequent [*] installment shall be paid within [*] days of the
previous [*] installment.
2.3 If the results of the Stage I Research are successful as determined by
[*], and [*] desires to proceed to Stage II, [*] shall select one or more AMRI
Derivatives for research pursuant to the Stage II Research Plan.
2.4 Subject to [*] desire to proceed under Section 2.3, AMRI shall perform
research in accordance with the Stage II Research Plan for a period not to
exceed [*]. CUBIST shall pay AMRI [*] dollars [*] for [*] FTE's [*] for the
Stage II Research, plus the cost of materials to the extent that CUBIST has
provided prior authorization for such costs. CUBIST shall pay the first [*]
payment to AMRI for the Stage II Research within [*] days after commencement of
the Stage II Research, and shall make each of the subsequent payments on a [*]
basis thereafter. CUBIST shall pay AMRI for the cost of materials within [*]
days of receipt of an invoice therefor. The parties anticipate that AMRI shall
provide to CUBIST approximately [*] mgs of each of [*] AMRI Derivatives having
at least [*] purity within [*] of the initiation of Stage II, and it is
expressly understood that the achievement thereof is not an obligation or
requirement of this Agreement
2.5 CUBIST shall screen for biological activity of AMRI Derivatives
provided by AMRI to CUBIST and CUBIST shall report all results of all such
screening to AMRI.
3. SUPPLY OF SELECTED AMRI DERIVATIVES
3.1 (a) With respect to supply of AMRI Derivatives for [*], CUBIST agrees
that AMRI shall have the sole and exclusive right of first negotiation, for a
period of [*] days, to negotiate with CUBIST the terms and conditions of an
agreement by which AMRI will supply to CUBIST CUBIST's requirements for AMRI
Derivatives for such purposes. Either Party can initiate such [*] period by
written notice to the other Party, provided such written notice is given no
earlier than the time that CUBIST notifies AMRI in writing which AMRI Derivative
CUBIST has selected for [*] (the "Selected
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AMRI Derivative"). Upon receipt of written notice to initiate the negotiation
period, the Parties shall negotiate in good faith the terms and conditions of a
supply agreement for a period of [*].
(b) If the Parties fail to reach agreement in such period, CUBIST
shall have the right to supply or have supplied by a Third Party the Selected
AMRI Derivative. CUBIST will have the right to produce or have produced the
Selected AMRI Derivative by use of [*] Processes, and/or AMRI's proprietary
synthesis technology that exists at such time. In no event shall AMRI have the
right to provide or license such AMRI Derivatives to any Third Party.
4. GRANT OF LICENSES AND ASSIGNMENT
4.1 LICENSE.
(a) AMRI hereby grants to CUBIST and its Affiliates a worldwide,
exclusive, royalty-bearing license with the right to grant sublicenses in
accordance with the terms of this Agreement, under AMRI's interest in Research
Patents, AMRI Process Technology and AMRI Background Patents to develop,
register, use, make, have made, import, export, offer to sell, and sell CUBIST
Products.
(b) CUBIST agrees that it will use AMRI Process Technology, Research
Patents and AMRI Background Patents only for CUBIST PRODUCTS as licensed under
this Agreement, only as long as licensed under this Agreement and in each case
in accordance with the terms and conditions of this Agreement.
4.2 SUBLICENSING BY CUBIST.
(a) CUBIST shall have the right to grant sublicenses to a Third
Party under the licenses granted pursuant to Section 4.1 provided that (i) such
sublicense does not substantively alter AMRI's rights or CUBIST's obligations to
AMRI hereunder, and (ii) each Sublicensee agrees in writing to comply with
Sections 8.3, 8.4, 10, 11.1(b), 11.2 and 11.3 of this Agreement,
(b) Any sublicense granted by CUBIST to a Third Party shall include
a provision [*] and a provision [*] in the event that the license [*].
4.3 No right or license is granted to CUBIST hereunder except as expressly
granted under Section 4.1.
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5. DEVELOPMENT AND COMMERCIALIZATION.
5.1 DEVELOPMENT EFFORTS BY CUBIST.
(a) CUBIST will use reasonable efforts consistent with the efforts
exerted by CUBIST in pursuing the development and commercialization of its other
products of similar stage, technical challenge and economic potential, [*], to
develop and commercialize [*] CUBIST Product in a Major Market. In the event
that CUBIST is not interested in pursuing development and/or commercialization
of a AMRI Derivative Product in any country or countries, CUBIST shall promptly
notify AMRI, and [*]. Notwithstanding the foregoing, in no event is CUBIST
obligated to grant such rights.
5.2 REPORTING.
Within [*] days after the end of each calendar year, CUBIST shall
provide to AMRI an annual project status report (including the status of
regulatory approvals) of the development, and registration of each AMRI
Derivative Product. All such reports by CUBIST shall be treated as Confidential
Information of CUBIST and shall be subject to the restrictions imposed under
Section 11.2. Within [*] days after the end of each calendar year, CUBIST shall
provide to AMRI an annual project status report of the development and
registration of each CUBIST Derivative Product. All such reports by CUBIST shall
be treated as Confidential Information of CUBIST and shall be subject to the
restrictions imposed under Section 11.2. In no event will CUBIST be required to
provide structural information of such CUBIST Derivative Product.
5.3 REMEDY
AMRI shall have the right to terminate this Agreement in its entirety by
written notice to CUBIST if CUBIST (i) has not filed an IND for a CUBIST Product
within [*] years of the Effective Date (ii) has not initiated a [*] for a CUBIST
Product within [*] years of the IND filing or (iii) has not initiated [*] for a
CUBIST Product within [*] years of the completion of a [*].
6. FEE; MILESTONE PAYMENTS AND ROYALTIES.
6.1 MILESTONE PAYMENTS BY CUBIST. CUBIST shall pay AMRI each of the
following non-refundable and non-creditable milestone payments the first time
that each milestone is achieved for a CUBIST Product, whether achieved by
CUBIST, its Affiliates, its Sublicensee or distributor:
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(a) [*] upon initiation of the first Phase I clinical study;
(b) [*] upon commencement of the first Phase III clinical trial or
the equivalent thereof in any Major Market;
(c) [*] upon the first filing for regulatory approval in any Major
Market;
(d) [*] upon the first receipt of regulatory approval in any Major
Market;
(e) In the event that any of the milestones of Section 6.1(a)-(d)
are achieved and one or more preceding milestone payments have not been made,
then the payment required by the preceding milestone(s) shall also be paid at
the same time. Cubist shall be obligated to pay each of milestone payments (a)
through (d) only once.
6.2 ROYALTIES. In partial consideration of the rights and licenses granted
by AMRI to CUBIST under this Agreement, during the Royalty Term, CUBIST shall
pay to AMRI a royalty on Net Sales of CUBIST Products as follows:
(a) Royalties on Net Sales of AMRI Derivative Products
(i) [*] of aggregate Net Sales up to [*] dollars;
(ii) [*] of aggregate Net Sales over [*] dollars.
(b) CUBIST will pay to AMRI a royalty of [*] of Net Sales of CUBIST
Derivative Products.
In calculating the royalty due under this Section 6.2 with respect to Net
Sales of CUBIST Products during any period of less than a calendar year, the
foregoing thresholds for a calendar year Net Sales shall be prorated in
accordance with the duration of such period.
6.3 OBLIGATION TO PAY ROYALTIES. The obligation to pay royalties to AMRI
under this Section 6 is imposed only once with respect to the same unit of
CUBIST Product regardless of the number of patents pertaining thereto. In the
case where the CUBIST Product is to be resold, there shall be no obligation to
pay royalties to AMRI under this Section 6 on sales of CUBIST Products between
CUBIST and its Affiliates or between any of them and its distributor,
co-marketer or Sublicensee, but in such instances the obligation to pay
royalties shall arise upon the resale based on Net Sales of the reseller.
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7. REPRESENTATIONS AND WARRANTIES.
7.1 REPRESENTATIONS AND WARRANTIES OF BOTH PARTIES. Each Party represents
and warrants to the other Party that, as of the date of this Agreement, such
Party is duly organized and validly existing and has full corporate power and
authority to enter into this Agreement and to carry out the provisions hereof.
Additionally, AMRI and CUBIST each represents and warrants that its employees
and agents have an obligation to assign all rights in any intellectual property
to AMRI or CUBIST, respectively.
7.2 UNLESS OTHERWISE SET FORTH IN THIS AGREEMENT, NEITHER AMRI NOR CUBIST
MAKES ANY OTHER REPRESENTATION OR WARRANTY HEREUNDER AND DISCLAIMS ALL OTHER
REPRESENTATIONS AND WARRANTIES, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR USE OR WITH RESPECT TO THE VALIDITY,
ENFORCEABILITY, OR PATENTABILITY OF PATENTS OR THAT CUBIST PRODUCT WILL NOT
INFRINGE PATENT RIGHTS OF A THIRD PARTY.
8. PAYMENTS AND REPORTS.
8.1 ROYALTY PAYMENTS. All royalty payments due hereunder shall be paid [*]
within [*] days of the end of each [*]. Each such payment shall be accompanied
by a statement, CUBIST Product by CUBIST Product and country-by-country (unless
otherwise mutually agreed in writing by the parties), of the amount of gross
sales used in calculating Net Sales, the calculation of Net Sales and the units
of CUBIST Product sold during such [*], the amount of royalties due on such Net
Sales, the conversion rates used in converting to United States Dollars and any
other information reasonably requested by AMRI to enable AMRI to determine
amounts it is owed hereunder.
8.2 MODE OF PAYMENT. CUBIST shall make all payments required under this
Agreement as directed by AMRI from time to time in United States Dollars.
Whenever conversion from any foreign currency shall be required, such conversion
shall be at the average rate of exchange for the last twenty (20) business days
of the applicable calendar quarter as published in the Wall Street Journal, New
York edition.
8.3 RECORDS RETENTION. CUBIST and its Affiliates and its Sublicensees,
distributors and co-marketers shall keep complete and accurate records
pertaining to the sale of CUBIST Products in the Territory and covering all
transactions from which Net Sales are derived for a period
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of three calendar years after the year in which such sales occurred, and in
sufficient detail to permit AMRI to confirm the accuracy of royalty payments due
hereunder.
8.4 AUDIT REQUEST. At the request and expense (except as provided below
and no more than once each calendar year) of AMRI, CUBIST and its Affiliates and
its Sublicensees, distributors and co-marketers shall permit an independent,
certified public accountant jointly selected by AMRI and CUBIST, at reasonable
times and upon reasonable notice, to examine those records and all other
material documents directly relating to, or directly relevant to, Net Sales of
Cubist Product in the possession or control of CUBIST and/or its Affiliates or
its Sublicensees, distributors and co-marketers, for a period of three years
after such royalties have accrued. Said accountant shall sign an appropriate
confidentiality agreement with CUBIST, and shall not disclose to AMRI any
information other than information directly relating to said reports, royalties,
and payments. Results of any such examination shall be made available to both
Parties. If, as a result of any inspection of the books and records of CUBIST or
its Affiliates or its Sublicensees, distributors and co-marketers it is shown
that Cubist underpaid by more than 7 %, Cubist will pay for the costs associated
with the audit. Prompt adjustments shall be made by the Parties to reflect any
underpayment or overpayment determined to have been made as a result of such
audit.
8.5 TAXES. In the event that CUBIST is required by the revenue authorities
in any country to withhold any tax, such amount shall be deducted from the
royalty or other payment to be made by CUBIST, and CUBIST shall notify AMRI and
promptly furnish AMRI with copies of any tax certificate or other documentation
evidencing such withholding. Each Party agrees to cooperate with the other Party
in claiming exemptions from such deductions or withholdings under any agreement
or treaty in effect.
9. INTELLECTUAL PROPERTY.
9.1 OWNERSHIP OF INVENTIONS. Ownership of inventions shall be determined
in accordance with U.S. Patent Laws; inventions shall be licensed as
set forth in Article 4.
9.2 RESEARCH PATENTS. In the event that a Research Patent is jointly owned
by both AMRI and Cubist, neither party may license such patent without obtaining
the prior written consent of the other.
9.3 PATENT FILING, MAINTENANCE AND PROSECUTION.
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(a) RESEARCH PATENTS CLAIMING DERIVATIVES ONLY. CUBIST shall file,
prosecute and maintain Research Patents claiming AMRI Derivatives at CUBIST's
cost and expense through patent counsel selected by CUBIST, and CUBIST shall
provide AMRI copies of all documentation relating to such patent activities,
with sufficient time for AMRI to review and provide comments thereto. CUBIST
shall disclose to AMRI the complete texts of all such patents and patent
applications filed by CUBIST, as well as all information received concerning the
institution or possible institution of any interference, opposition,
re-examination, reissue, revocation, nullification or any official proceeding
involving any Research Patents. AMRI shall have the right to review such pending
applications and other proceedings and make recommendations to CUBIST concerning
them and their conduct. AMRI and its employees agree to cooperate with CUBIST in
taking all steps which CUBIST believes reasonably necessary or desirable to
secure its rights on this property at CUBIST's cost.
CUBIST shall give [*] days prior written notice to AMRI of any intent to
cease prosecution and/or maintenance of any Research Patents and, in such case,
on a county-by-country basis, shall permit AMRI, at its sole discretion, to
continue prosecution or maintenance at its own expense. If AMRI elects to
continue such prosecution or maintenance, AMRI shall notify CUBIST within such
[*] day period, and CUBIST shall execute such documents and perform such acts as
may be reasonably requested by AMRI to assign all of CUBIST's right, title and
interest in and to such Research Patents to AMRI and CUBIST's license to such
Research Patents shall terminate.
(b) RESEARCH PATENTS CLAIMING DERIVATIVES AND PROCESSES. In the
event that Research Patents claim AMRI Process Technology or other processes for
making AMRI Derivatives, in addition to AMRI Derivatives, the patents shall be
filed, prosecuted and maintained by patent counsel selected jointly by Cubist
and AMRI, and the parties shall [*]. Such patent counsel shall represent both
AMRI and Cubist.
(c) AMRI BACKGROUND PATENTS AND AMRI PROCESS TECHNOLOGY. Except as
set forth in (b) above, AMRI shall file, prosecute and maintain patents in AMRI
Background Patents, and AMRI Process Technology licensed to CUBIST hereunder.
AMRI shall provide CUBIST copies of all documentation relating to such patent
activities.
9.4 INFRINGEMENT ACTIONS. Each of AMRI and/or CUBIST shall promptly notify
the other in writing of any alleged or threatened infringement of any patents
licensed hereunder, or of any allegation by a
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Third Party that the activity of either of the parties pursuant to this
Agreement infringes or may infringe the intellectual property rights of such
Third Party. In the event of the institution of any suit by a Third Party
against CUBIST, its Affiliates or its Sublicensees for patent infringement
involving the use, sale, distribution or marketing of any CUBIST Product, CUBIST
shall defend such action at its own expense. CUBIST shall have the right to
settle the suit or consent to an adverse judgment thereto, in its sole
discretion. During the pendency of such action, all royalties due hereunder
shall continue to be paid by CUBIST. CUBIST shall assume full responsibility for
the payment of any award for damages, or any amount due pursuant to any
settlement entered into by CUBIST with such Third Party.
In the event a Third Party allegedly infringes an Research Patents which
do not have claims to an AMRI Derivative, then AMRI shall have the first right
to prosecute such action at its own expense and represented by counsel of its
own choice. In the event a claim in a Research Patent directed to an AMRI
Derivative is infringed, then Cubist shall have the right to participate in such
action represented by counsel of its own choice and at its own expense.
Both Cubist and AMRI agree to cooperate fully with each other in the event
of any of offensive or defensive litigation.
10. INDEMNIFICATION.
10.1 BY CUBIST. CUBIST shall indemnify and hold AMRI and its directors,
officers, employees, shareholders and agents, harmless from and against any and
all Third Party claims, suits or demands for liabilities, damages, losses, costs
and expenses (including the reasonable fees of attorneys and other
professionals) directly arising out of or directly resulting from the
development, manufacture, use, distribution or sale of any CUBIST Product by
CUBIST, its Affiliates, distributors, co-marketers or Sublicensees or any person
or entity that prepares or manufactures CUBIST Product or AMRI Derivatives or
CUBIST Derivatives for or on behalf of any, of the foregoing or any person or
entity who receives or obtains (directly or indirectly) CUBIST Product or AMRI
Derivatives from any of the foregoing, except those losses which arise out of
the gross negligence or intentional misconduct of AMRI.
10.2 BY AMRI. AMRI shall indemnify and hold CUBIST and its directors,
officers, employees, shareholders and agents, harmless from and against any and
all Third Party claims, suits or demands for liabilities, damages, losses, costs
and expenses (including the reasonable fees of attorneys and other
professionals) directly arising out of or directly resulting
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from work performed by AMRI pursuant to the Research Program, except those
losses which arise out of the gross negligence or intentional misconduct of
CUBIST and except for those losses as to which AMRI is indemnified pursuant to
Section 10.2.
10.3 COSTS OF ENFORCEMENT. As the Parties intend complete indemnification,
the indemnifying Party shall also reimburse all costs and expenses of enforcing
any provision of this Section 10.
10.4 CONDITIONS TO INDEMNIFICATION. A person or entity that intends to
claim indemnification under this Section (the "Indemnitee") shall promptly
notify the other Party (the "Indemnitor") of any loss, claim, damage, liability
or action in respect of which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall assume the defense thereof with
counsel mutually satisfactory to the Indemnitee whether or not such claim is
rightfully brought; provided, however, that an Indemnitee shall have the right
to retain its own counsel, with the fees and expenses to be paid by the
Indemnitor if Indemnitor does not assume the defense, or if representation of
such Indemnitee by the counsel retained by the Indemnitor would be inappropriate
due to actual or potential differing interests between such Indemnitee and any
other person represented by such counsel in such proceedings. The indemnity
agreement in this Section shall not apply to amounts paid in settlement of any
loss, claim, damage, liability or action if such settlement is effected without
the consent of the Indemnitor, which consent shall not be withheld or delayed
unreasonably. The failure to deliver notice to the Indemnitor within a
reasonable time after the commencement of any such action, only if prejudicial
to its ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Section, but the omission so to deliver
notice to the Indemnitor will not relieve it of any liability that it may have
to any Indemnitee otherwise than under this Section. The Indemnitee under this
Section, its employees and agents, shall cooperate fully with the Indemnitor and
its legal representatives in the investigations of any action, claim or
liability covered by this indemnification.
10.5 Any and all licensees of CUBIST, with respect to CUBIST Product,
shall agree to the same indemnity as in Section 10.1 of this Agreement and AMRI
shall be made a Third Party beneficiary thereof with the right of enforcement.
11. CONFIDENTIALITY.
11.1 CONFIDENTIALITY AND EXCEPTIONS.
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(a) Except to the extent expressly authorized by this Agreement or
otherwise agreed to in writing, AMRI agrees that, it, its Affiliates and its
Sublicensees, if any, shall use reasonable efforts to keep, and to ensure that
their officers and directors keep completely confidential and shall not publish
or otherwise disclose and shall not use for any purpose any information
furnished to it by CUBIST, its Affiliates or its Sublicensees, if any, except to
the extent that it can be established by AMRI by competent proof that such
information: (i) is or hereafter becomes generally available to the public other
than by reason of any default by AMRI with respect to its confidentiality
obligations hereunder; (ii) was already known to AMRI as evidenced by prior
written documents in its possession; (iii) is disclosed to AMRI by a Third Party
who is not in default of any confidentiality obligation to CUBIST; or (iv) is
independently developed by or for AMRI without reference to or reliance upon the
information furnished by CUBIST ("Confidential Information"). Information
disclosed by one Party to the other shall remain the property of the disclosing
Party unless otherwise specified in this Agreement.
(b) Except to the extent expressly authorized by this Agreement or
otherwise agreed to in writing, CUBIST agrees that, it, its Affiliates and its
Sublicensees, if any, shall use reasonable efforts to keep, and to ensure that
their officers and directors keep completely confidential and shall not publish
or otherwise disclose and shall not use for any purpose any information
furnished to it by AMRI, or its Affiliates, if any, except to the extent that it
can be established by CUBIST by competent proof that such information: (i) is or
hereafter becomes generally available to the public other than by reason of any
default by CUBIST with respect to its confidentiality obligations hereunder,
(ii) was already known to CUBIST as evidenced by prior written documents in its
possession; (iii) is disclosed to CUBIST by a Third Party who is not in default
of any confidentiality obligation to AMRI; or (iv) is independently developed by
or for AMRI without reference to or reliance upon the information furnished by
AMR1 ("Confidential Information"). Information disclosed by one Party to the
other shall remain the property of the disclosing Party unless otherwise
specified in this Agreement:
11.2 Notwithstanding the foregoing, the Parties may disclose Confidential
Information (i) to governmental authorities to facilitate the issuance of
marketing approvals for a CUBIST Product, provided that reasonable measures
shall be taken to assure confidential treatment of such information, provided
the non-disclosing party is given prior written notice of such disclosure, (ii)
to Third Parties under appropriate terms and conditions, including
confidentiality provisions equivalent to those in this
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Agreement, for consulting, manufacturing, development, external testing,
marketing, clinical trials and licensing or potential licensing of CUBIST
Product in accordance with this Agreement; and (iii) to comply with applicable
laws or regulations (including, without limitation, to comply with SEC, NASDAQ
or stock exchange disclosure requirements) or order by a court or other
regulatory body having competent jurisdiction; provided that if a Party is
required to make any such disclosure of the other Party's Confidential
Information under (i)-(iii) above, it will to the extent practicable, give
reasonable advance notice to the other Party of such disclosure requirement and,
will use its reasonable best efforts to secure confidential treatment of such
Confidential Information required to be disclosed.
11.3 The obligations of this Section 11 shall terminate [*] after the
termination of this Agreement.
12. TERM; TERMINATION.
12.1 TERM
This Agreement shall commence as of the Effective Date and, unless sooner
terminated as provided hereunder, shall expire as follows:
(a) As to each CUBIST Product in each country in the Territory, this
Agreement shall expire upon the expiration of the Royalty Term with respect to
such CUBIST Product in such country.
(b) This Agreement shall expire in its entirety upon the termination
of the Royalty Term with respect to all CUBIST Products in all countries in the
Territory.
12.2 Notwithstanding the foregoing, CUBIST shall have the right to
terminate the Agreement at any time upon [*] to AMRI, provided that CUBIST pays
all amounts for work performed prior to the effective date of the termination.
12.3 BREACH.
(a) Failure by either Party to comply with any of its material
obligations contained in this Agreement shall entitle the other Party to give to
the Party in default notice specifying the nature of the default and requiring
it to cure such default. If such default is not cured within [*] days [*] days
in the event of a default with respect to an obligation to pay money) after
receipt of such notice, the notifying Party shall be entitled, without
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prejudice to any of its other rights conferred on it by this Agreement, and in
addition to any other remedies available to it by law or in equity, to terminate
this Agreement in its entirety, by giving written notice to take effect
immediately upon delivery of such notice. The right of either Party to terminate
this Agreement, as provided in this Section 12.3, shall not be affected in any
way by its waiver or failure to take action with respect to any previous
default.
(b) An election of remedy by a Party for a material breach of this
Agreement under this Section 12.3 on one occasion shall not constitute a waiver
as to any other remedy that may be available to such Party under this Section
12.3 as to any material breach on another occasion.
12.4 EFFECT OF EXPIRATION OR TERMINATION.
(a) Following expiration of this Agreement under Section 12.1 with
respect to a CUBIST Product in a country, CUBIST shall have the [*] in such
country under the license granted pursuant to [*] of this Agreement. Following
[*] in its entirety under [*], CUBIST shall have the [*] in all countries so
long as CUBIST continues to [*] provided for herein.
(b) In the event that this Agreement in terminated by AMRI under
Section 12.3 as a result of CUBIST's failure to make payments owed to AMRI, or
under Section 5.3, CUBIST will grant AMRI a [*] to [*] containing [*], including
a [*].
12.5 Either Party may terminate this Agreement, if, at any time, the other
Party becomes insolvent or the other Party shall file in any court or agency
pursuant to any statute or regulation of a country in the Territory a petition
of bankruptcy or insolvency or for reorganization or for an arrangement or for
the appointment of a receiver of trustee of the other Party or of its assets or
if the other Party proposes a written agreement of composition or extension of
its debts or if the other Party shall be served with an involuntary petition
against it, filed in any insolvency proceeding, and such petition shall not be
dismissed within [*] after filing thereof, or if the other party shall make an
assignment for the benefit of its creditors. Notwithstanding the bankruptcy of
AMRI or the impairment of performance of AMRI of its obligations under this
section, CUBIST shall be entitled to retain the licenses granted herein,
provided it continues to comply with its obligations to AMRI hereunder.
12.6 ACCRUED RIGHTS, SURVIVING OBLIGATIONS.
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(a) Termination, relinquishment or expiration of this Agreement for
any reason shall be without prejudice to any rights which shall have accrued to
the benefit of either Party prior to such termination, relinquishment or
expiration. Such termination, relinquishment or expiration shall not relieve
Party from obligations which are expressly indicated to survive termination or
expiration of this Agreement.
(b) Termination, relinquishment or expiration of this Agreement
shall not terminate CUBIST's obligation to pay all royalties and other payments
that shall have accrued prior to such termination. All of the Parties' rights
and obligations under Sections 4.1 (b) and (c), 6.1, 6.2, 6.3, 8.1, 8.2, 8.3,
8.4, 8.5, 9.1, 9.2, 12.4(b), 12.6 and Articles 10, 11 and 14 shall survive
termination, relinquishment or expiration hereof.
12.7 This Agreement may not be terminated by either Party except as
specifically provided in this Section 12.
13. FORCE MAJEURE.
13.1 EVENTS OF FORCE MAJEURE. Neither Party shall be held liable or
responsible to the other Party nor be deemed to be in default under or in breach
of any provision of this Agreement for failure or delay in fulfilling or
performing any obligation of this Agreement when such failure or delay is due to
FORCE MAJEURE, and without the fault or negligence of the Party so failing or
delaying. For purposes of this Agreement, FORCE MAJEURE is defined as causes
beyond the control of the Party, including, without limitation, acts of God;
acts, regulations, or laws of any government; acts of regulatory or medical
advisory groups to the extent that it is beyond the control of a Party; war;
civil commotion; destruction of production facilities or materials by fire,
flood, earthquake, explosion or storm; labor disturbances; epidemic; and failure
of pubic utilities or common carriers. In such event CUBIST or AMRI, as the case
may be, shall immediately notify the other Party of such inability and ability
is expected to continue. The Party giving such notice shall thereupon be excused
from such of its obligations under this Agreement as it is thereby disabled from
performing for so long as it is so disabled, provided, that the Parry giving
such notice exerts reasonable efforts to resume such performance.
14. MISCELLANEOUS.
14.1 RELATIONSHIP OF PARTIES. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee or joint
venture relationship between the Parties. No Party shall incur any
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debts or make any commitments for the other, except to the extent, if at all,
specifically provided herein.
14.2 ASSIGNMENT. Neither Party shall, be entitled to assign its rights
hereunder without the express written consent of other Party hereto, which
consent shall not be unreasonably withheld, except that both CUBIST and AMRI may
otherwise assign their respective rights and transfer their respective duties
hereunder to any assignee of all or substantially all of their respective
businesses (or that portion thereof to which this Agreement relates) or in the
event of their respective merger or consolidation or similar transaction. CUBIST
may assign this Agreement to an Affiliate but such assignment shall not relieve
CUBIST of its obligations hereunder. No assignment and transfer shall be valid
or effective unless and until the assignee/transferee shall agree in writing to
be bound by the provisions of this Agreement in which case the Agreement will
inure to the benefit of such successors and assigns.
14.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
14.4 NOTICE. Any notice or request required or permitted to be given under
or in connection with this Agreement shall be deemed to have been sufficiently
given if in writing and personally delivered or sent by certified mail (return
receipt requested), facsimile transmission (receipt verified), or overnight
express courier service (signature required), prepaid, to the Party for which
such notice is intended, at the address set forth for such Party below:
(a) In the case of CUBIST, to:
Xxxx Xxxxxx, Ph.D, MBA
Senior Vice President, Corporate Development Cubist
Pharmaceuticals
00 Xxxxx Xxxxxx Xxxxxxxxx, XX 00000 With a copy to:
Contract Manager
(b) In the case of AMRI, to:
Xx. Xxxxx X. Xxxxxx, CPA
Chief Financial Officer
Albany Molecular Research, Inc.
XX Xxx 00000
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00 Xxxxxxxxx Xxxxxx
Xxxxxx, XX 00000-0000
or to such other address for such Party as it shall have specified by like
notice to the other Party, provided that notices of a change of address shall be
effective only upon receipt thereof. If delivered personally or by facsimile
transmission, the date of delivery shall be deemed to be the date on which such
notice or request was given. If sent by overnight express courier service, the
date of delivery shall be deemed to be the next business day after such notice
or request was deposited with such service. If sent by certified mail, the date
of delivery shall be deemed to be the third business day after such notice or
request was deposited with the U.S. Postal Service.
14.5 USE OF NAME. Except as otherwise provided herein, neither Party shall
have any right, express or implied, to use in any manner the name or other
designation of the other Party or any other trade name or trademark of the other
Party for any purpose in connection with the performance of this Agreement.
14.6 EXCLUSIVITY. AMRI expressly acknowledges that the during the term of
this Agreement, as a result of the exclusive licenses granted to CUBIST
hereunder, AMRI shall not have the right, directly or indirectly, itself or
through or in connection with any Third Party, to conduct research, develop,
make or market AMRI Derivatives, CUBIST Derivatives or daptomycin. AMRI further
agrees that for a period of [*] years after the termination of this Agreement,
it shall not directly or indirectly conduct research, develop, make or market
AMRI Derivatives, CUBIST Derivatives or daptomycin. CUBIST expressly
acknowledges that nothing in the terms of this Agreement shall prevent AMRI from
utilizing AMRI Background Patents AMRI Process Technology, or Research Patents
in any manner for compounds which are not AMRI Derivatives or CUBIST
Derivatives.
14.6 PUBLIC ANNOUNCEMENTS. Except as required by law, rule or regulation
(including, without limitation, disclosure requirements of the U.S. Securities
and Exchange Commission, NASDAQ or any other stock exchange on which securities
issued by AMRI are traded), neither Party shall make any public announcement
concerning this Agreement or the subject matter hereof without the prior written
consent of the other, which shall not be unreasonably withheld. It shall not be
unreasonable for a Party to withhold consent with respect to any public
announcement containing any of such Party's Confidential Information. In the
event of a required or desired public announcement the Party making such
announcement shall provide the other Party with a copy of the proposed text
prior to such announcement sufficiently in advance of the scheduled release of
such announcement to
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afford such other Party a reasonable opportunity to review and comment upon the
proposed text. Once the text is approved, either Party may disclose the
substance of that which has been previously disclosed to the public.
14.7 WAIVER. A waiver by either Party of any of the terms and conditions
of this Agreement in any instance shall not be deemed or construed to be a
waiver of such term or condition for the future, or of any subsequent. breach
hereof. All rights, remedies, undertakings, obligations and agreements contained
in this Agreement shall be cumulative and none of them shall be in limitation of
any other remedy, right, undertaking, obligation or agreement of either Party.
14.8 COMPLIANCE WITH LAW. CUBIST and AMRI agree to comply with all
applicable laws, rules and regulations with respect to their activities under
this Agreement.
14.9 SEVERABILITY. When possible, each provision of this Agreement will be
interpreted in such manner as to be effective and valid under applicable law,
but if any provision of this Agreement is held to be prohibited by or invalid
under applicable law, such provision will be ineffective only to the extent of
such prohibition or invalidity, without invalidating the remainder of this
Agreement and the parties shall negotiate, in good faith, a new provision which
will, as closely as possible, carry out the intentions of the parties provided
for in the invalidated provision. If such agreement is not reached in sixty (60)
days, the affected Party(ies) may terminate this Agreement.
14.10 AMENDMENT. No amendment, modification or supplement of any
provisions of this Agreement shall be valid or effective unless made in writing
and signed by a duly authorized officer of each Party.
14.11 GOVERNING LAW. This Agreement shall be governed by and interpreted
in accordance with the laws of the Commonwealth of Massachusetts without regard
to its choice of law principles. In the event that either Party desires to
initiate litigation with respect to this Agreement, such litigation shall be
conducted in an appropriate court in the Commonwealth of Massachusetts to the
extent possible.
14.12 ENTIRE AGREEMENT. This Agreement, together with the Exhibits hereto,
sets forth the entire agreement and understanding between the Parties as to the
subject matter hereof and merges all prior discussions and negotiations between
them, and neither of the Parties shall be bound by any conditions, definitions,
warranties, understandings or representations with respect to such subject
matter other than as expressly provided herein or as
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duly set forth on or subsequent to the date hereof in writing and signed by a
proper and duly authorized officer or representative of the Party to be bound
thereby.
14.13 PARTIES IN INTEREST. All the terms and provisions of this Agreement
shall be binding upon, inure to the benefit of and be enforceable by the Parties
hereto and their respective permitted successors and assigns.
14.14 DESCRIPTIVE HEADINGS. The descriptive headings of this Agreement are
for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.
14.15 COUNTERPARTS. This Agreement may be executed simultaneously in any
number of counterparts, any one of which need not contain the signature of more
than one Party but all such counterparts taken together shall constitute one and
the same agreement.
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be
executed by its duly authorized officer as of the day and year first above
written.
ALBANY MOLECULAR RESEARCH, INC.
By: /s/ Xxxxxx X'Xxxxx
-------------------------------------
Name: Xxxxxx X'Xxxxx
-----------------------------------
Title: Chairman and CEO
----------------------------------
CUBIST PHARMACEUTICALS, INC.
By: /s/ Xxxx Xxxxxx
-------------------------------------
Name: Xxxx Xxxxxx
------------------------------------
Title: Sr Vice President
----------------------------------
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