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EXHIBIT 10.10
ALLIANCE AGREEMENT
This Alliance Agreement (this "Agreement") is made and entered into as
of the ____ day of August 1996, by and between Medicines Development Company, a
Delaware corporation (the "Company"), and PharmaBio Development Inc., a North
Carolina corporation and a wholly owned subsidiary of Quintiles Transnational
Corp. ("PharmaBio").
WHEREAS, the Company, PharmaBio, Warburg, Pincus, Ventures L.P., MPM
Medicines L.P., Hanseatic Americas LDC, Clive Meanwell, Scott Johnson, and
Ansbert Gadicke are parties to a stock purchase agreement dated as of the even
date herewith (the "Purchase Agreement"); and
WHEREAS, a condition to closing pursuant to Section 4.5 of the Purchase
Agreement is the execution and delivery of this Agreement by the Company and
PharmaBio;
NOW, THEREFORE, in consideration of the terms and conditions herein
contained and contained in the Purchase Agreement, the Company and PharmaBio
agree as follows:
1.0 SCOPE OF SERVICES
-----------------
1.1 SERVICES RELATING TO COMPANY'S DEVELOPMENT PROGRAMS
As reasonably requested by the Company from time to time, PharmaBio
shall provide services to the Company to review and evaluate, jointly with the
Company, development programs created by the Company relating to potential or
actual product acquisitions. Such services shall be provided at no charge to the
Company by PharmaBio. The parties acknowledge that the purpose of this
collaboration is to optimize the duration, cost, specifications and quality
aspects of each of the Company's product development programs, and that the
parties anticipate that this collaborative planning process will lead to
substantial improvements in product development and performance compared with
the performance considered normal for the biopharmaceutical industry. The
parties further acknowledge that plans relating to product development involve a
dynamic process, and that such plans may require modification from time to time
in order to achieve optimal duration, cost and quality performances. The parties
agree to endeavor to create a collaborative relationship in which planning and
product development can be pursued effectively and efficiently. Unless otherwise
agreed by the Company, PharmaBio shall provide such services reasonably
requested by the Company, subject to Section 1.5.
1.2 PROJECT SERVICES
With respect to each of the Company's products, the Company shall
consult with PharmaBio regarding all services which the Company desires to
outsource relating to such products. All such services within the scope of
PharmaBio's (and its affiliates') then customary services shall be offered to
PharmaBio and PharmaBio shall agree to perform
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such services reasonably requested by the Company, subject to Section 1.5.
Services provided by PharmaBio shall include, but not be limited to, clinical
development services, non-clinical development services, project management
services, expert consultation regarding project implementation, pharmaeconomic
services, regulatory affairs services, post-marketing clinical, regulatory and
pharmacosurveillance services, and statistical, statistical programming, data
processing, data management, and clerical services.
1.3 SERVICE AGREEMENTS
All services provided by PharmaBio to the Company shall be subject to
the terms and conditions of this Agreement. Additionally, as a condition to
acceptance of project services pursuant to Section 1.2 hereof, the Company and
PharmaBio shall enter into a project services agreement, which shall be
substantially in the form of PharmaBio's then standard form of services
agreement and in any event which shall contain provisions covering scope of
work, project specifications, quality standards, and fees and costs (consistent
with Section 2.0 hereof). All material services agreements shall be reviewed by
Dennis Gillings or Rachel Selisker.
1.4 PERFORMANCE OF SERVICES
In performing services referred to in Section 1.2, PharmaBio agrees to
assure that these services are conducted in substantial compliance with, when
appropriate, any applicable protocol and specifications and with all applicable
laws, rules and regulations of the subject jurisdictions. PharmaBio also agrees
to cause the services it is to perform pursuant to Section 1.0 hereof to be
rendered by one or more of its affiliates which also are direct or indirect
subsidiaries of Quintiles Transnational Corp. The Company acknowledges and
agrees that such services will be performed by affiliates of PharmaBio.
1.5 LIMITATION OF SERVICES
PharmaBio shall not be required to perform any services which, as
determined by PharmaBio in good faith, either: (i) are beyond PharmaBio's
customary scope of services; (ii) compromise PharmaBio's conflict of interest,
professional or ethical policies; or (iii) are beyond PharmaBio's reasonable
capacity. In the event that PharmaBio determines that it will decline to provide
the proposed services due to a conflict of interest relating thereto, PharmaBio
shall notify the Company as soon as practicable of any such conflict of
interest. As to any services declined by PharmaBio, at the Company's request
PharmaBio shall use its best efforts in locating and evaluating, jointly with
the Company, an alternative provider for the contemplated services. PharmaBio
may assist the Company in planning and managing projects performed by
alternative service providers.
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2.0 FEES FOR SERVICES
-----------------
2.1 AMOUNT OF FEES
The Company shall pay to PharmaBio its then standard fees for services
rendered pursuant to Section 1.0 hereof. PharmaBio shall provide the Company a
schedule of such standard fees from time to time upon request of the Company.
The parties agree that the standard fees of PharmaBio shall be the fees which
PharmaBio normally charges for the types of services proposed to be provided to
multinational pharmaceutical companies at the time such services are provided,
PharmaBio agrees to consult with the Company regarding PharmaBio's fees for each
project and to establish such fees in good faith, taking into consideration
constraints imposed by short duration development time and international
standards of quality. From time to time, upon request by the Company, PharmaBio
shall provide information to the Company which reasonably establishes that the
fees paid by Company to PharmaBio are Quintiles' then standard fees; provided,
however, that PharmaBio shall not be required to provide any information to the
Company which PharmaBio believes in good faith will compromise any
confidentiality arrangements between PharmaBio and its other clients. The
Company will pay PharmaBio on a use basis at cost for network/mainframe computer
time, online disk storage and for printing and supplies.
2.2 BONUS
2.2.1 BONUS FOR EXCEPTIONAL PERFORMANCE
At the time the parties enter into the service agreement with respect
to any project, the parties shall use their best efforts to agree in writing to
certain performance standards for such project (the "Bonus Standards") which
must be achieved by PharmaBio in order for it to be entitled to a payment in
excess of the fees provided by Section 2.1 (the "Bonus Fee") and to agree to the
overall fees and costs of the project under Section 2.0 (the "Planned Cost").
The parties acknowledge that a Bonus Standard shall be based on exceptional,
industry leading performance and such other levels of performance as may be
agreed to by the parties. The parties anticipate that the Bonus Fee shall be up
to ten percent (10%) of "net revenue" PharmaBio receives for a project under
this Section 2.0. "Net revenue" shall be determined in the same manner as it is
determined by Quintiles. Transnational Corp. for purposes of its audited
financial statements. Should the parties be unable to agree to the establishment
of the Bonus Standard, the Bonus Fee and the Planned Cost or as to whether
PharmaBio is entitled to the Bonus Fee, the dispute resolution procedures set
forth in Section 3.0 shall be followed. During the course of any project, the
parties may mutually agree in writing to modify the Bonus Standard, Bonus Fee or
Planned Cost.
2.2.2 PAYMENT OF BONUS FEE
If PharmaBio shall achieve any Bonus Standard for a project and the
actual fees and costs of such project shall be equal to or less than the Planned
Cost plus any fees and costs arising out of any change orders for such project,
PharmaBio shall be entitled to the
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Bonus Fee for such project, which shall be paid promptly by the Company upon
achievement of such Bonus Standard. The Bonus fee shall be paid, at PharmaBio's
option, as follows: (i) in cash or (ii) in a number of shares of common stock of
the Company equal to the Bonus Fee multiplied by one hundred ten percent (110%)
and divided by the Share Value (as defined below).
2.2.3 DETERMINATION OF SHARE VALUE
The "Share Value" shall be determined pursuant to this Section 2.2.3.
Upon PharmaBio's election to be paid a Bonus Fee in common stock of the Company,
by notice thereof to the Company, the Company promptly shall propose the Share
Value and deliver to PharmaBio a description in reasonable detail of the manner
by which the Company determined the proposed Share Value, which shall be
determined as of the time the Bonus Standard is achieved. Thereafter, the
parties shall use their best efforts and negotiate in good faith to agree to the
Share Value within thirty (30) days of PharmaBio's election. If the parties
cannot agree to the Share Value within such period, then the determination of
the Share Value shall be postponed until the next round of equity financing of
the Company following the achievement of the Bonus Standard. Promptly following
such next round, the Share Value shall be determined and shall be equal to the
average of the per share purchase price of the Company's common stock (or common
stock equivalent) issued in such round and the per share purchase price of the
Company's common stock (or common stock equivalent) in the immediately preceding
round of equity financing. Should the parties be unable to agree to the Share
Value, the dispute resolution procedure set forth in Section 3.0 shall be
followed. Nothing in this Section 2.2.3 shall be construed to preclude an
agreement in writing by the parties to determine or settle the Share Value in a
manner otherwise than as provided in this Section or to provide for the payment
of the Bonus Fee in cash rather than in common stock.
2.3 PAYMENT TERMS
PharmaBio will invoice the Company monthly or as separately agreed for
services rendered hereunder and payment shall be made by the Company within
thirty (30) days of receipt of itemized invoices for work completed. Overdue
payments shall accrue interest at the rate of thirteen percent (13%) per annum,
and payments overdue for more than ninety (90) days shall accrue interest at the
rate of eighteen percent (18%) per annum, plus reasonable attorneys' fees and
costs incurred by PharmaBio in connection with the collection thereof.
2.4 EXPENSES
PharmaBio shall be reimbursed by the Company for all reasonable and
necessary travel and lodging expenses incurred in the performance of services
provided herein which have been requested or approved by the Company. Payment
for such services shall be made to PharmaBio within thirty (30) days of receipt
by the Company of invoices or other evidence of such expenditures.
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3.0 DISPUTE RESOLUTION PROCEDURES
-----------------------------
The parties hereto recognize that a BONA FIDE dispute as to certain
matters may from time to time arise during the term of this; Agreement which
relate to a party's rights or obligations hereunder. In the event of the
occurrence of such a dispute, the parties shall through good faith negotiations
at the managerial level at which such matter arises endeavor to resolve the
dispute promptly. In the event that such dispute is not resolved promptly,
either party may, by written notice to the other party, have such dispute
referred to the review committee designated below, or their successors, and such
committee shall through good faith negotiation endeavor to resolve the dispute
by unanimous agreement of its members. The review committee shall be comprised
of five individuals, two each appointed by the Company and PharmaBio from such
party's executive officers or directors and one appointed by Warburg, Pincus,
Ventures L.P. The review committee initially shall be comprised of Clive
Meanwell, Scott Johnson, Dennis Gillings, Rachel Selisker, and Nicholas Lowcock.
In the event the review committee is not able to resolve such dispute promptly
by unanimous action, each party shall have the right to pursue any and all
remedies available at law or in equity. Neither party shall take any action
under contract or otherwise with respect to the dispute, and the Company shall
not proceed to refer any project work elsewhere for failure to obtain agreement
to perform services, without first having undertaken the foregoing procedure
with respect to the dispute and having notified the other party in writing that
it considers the dispute resolution procedures to have failed.
4.0 TERM
----
This Agreement shall remain in full force and effect for a period
beginning on the date hereof and ending when PharmaBio shall have ceased
performing services under this Agreement, or any project services agreement
entered into pursuant to this Agreement, with respect to the first three
products of the Company for which PharmaBio provides services. This Agreement
may be renewed or extended by the mutual written agreement of the parties.
Upon the termination of this Agreement, PharmaBio shall deliver to
Company all data and materials provided by Company to PharmaBio for the conduct
of services under this Agreement, except as otherwise required by applicable law
or regulation. All statistical data, all statistical reports, all data entries
and any other documentation produced as the result of services performed by
PharmaBio under the terms of this Agreement shall be delivered to Company at
such time as payment has been made to PharmaBio for all services performed.
PharmaBio reserves the right to retain one copy of all materials provided to
Company as the result of services performed by PharmaBio under this Agreement
for a period of five (5) years which will remain sealed unless a dispute arises
regarding the services performed by PharmaBio hereunder.
5.0 CONFIDENTIALITY
---------------
It is understood that during the course of this Agreement, PharmaBio
and its employees may be exposed to data and information which is confidential
and proprietary
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to the Company. All such data and information (hereinafter "Company Confidential
Information") written or verbal, tangible or intangible, made available,
disclosed, or otherwise made known to PharmaBio and its employees as a result of
services under this Agreement shall be considered confidential and shall be
considered the sole property of Company. All information regarding clinical
trials or clinical trial management and all information regarding PharmaBio's
operations, including but not limited to PharmaBio Property (as defined in
Section 6.0 below), disclosed by PharmaBio to the Company in connection with
this Agreement is proprietary, confidential information belonging to PharmaBio
(the "PharmaBio Confidential Information", and together with the Company
Confidential Information, the "Confidential Information"). The Confidential
Information shall be marked as confidential or otherwise represented by the
disclosing party as confidential either before or within a reasonable time after
its disclosure. The Confidential Information shall be used by the receiving
party and its employees only for purposes of performing the receiving party's
obligations hereunder. Each party agrees that it will not reveal, publish or
otherwise disclose the Confidential Information of the other party to any third
party without the prior written consent of the disclosing party, provided that
the foregoing obligations shall not apply to Confidential Information which:
(a) is or becomes generally available to the public other than
as a result of a disclosure by the receiving party;
(b) becomes available to the receiving party on a
non-confidential basis from a source which is not prohibited from
disclosing such information by a legal, contractual or fiduciary
obligation to the disclosing party;
(c) the receiving party develops independently of any
disclosure by the disclosing party;
(d) was in the receiving party's possession or known to the
receiving party prior to its receipt from the disclosing party; or
(e) is required by law to be disclosed.
This obligation of confidentiality and non-disclosure shall remain in
effect for a period of five years after the termination of this
Agreement.
6.0 OWNERSHIP
---------
All data and information necessary for PharmaBio to conduct project
assignments will be forwarded by the Company to PharmaBio. All data and
information generated or derived by PharmaBio as the result of services
performed by PharmaBio under this Agreement shall be and remain the exclusive
property of the Company. Any inventions that may evolve from the data and
information described above as the result of services performed by PharmaBio
under this Agreement shall belong to the Company and PharmaBio agrees to assign
all such inventions and/or patents to the Company. Notwithstanding the
foregoing, Company acknowledges that PharmaBio possesses certain inventions,
processes, know-how, trade secrets, improvements, other intellectual
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properties and other assets, including but not limited to laboratory analyses,
analytical methods, procedures and techniques, computer technical expertise and
software, which have been independently developed by PharmaBio (collectively
"PharmaBio Property"). The Company and PharmaBio agree that any PharmaBio
Property or improvements thereto which are used, improved, modified or developed
by PharmaBio under or during the term of this Agreement are the product of
PharmaBio's technical expertise possessed and developed by PharmaBio prior to or
during the performance of this Agreement and are the sole and exclusive property
of PharmaBio. The Company further acknowledges that PharmaBio's professional
staff possesses certain technical expertise and conceptual expertise in area of
drug development which have been independently developed by PharmaBio. The
Company and PharmaBio agree that such technical expertise, processes, methods,
approach or analyses used, improved, modified or developed by PharmaBio under or
during the term of the Agreement or are the product of PharmaBio's technical
expertise possessed and developed by PharmaBio prior to the date of this
Agreement and are the sole and exclusive property of PharmaBio.
7.0 LIMITATION OF LIABILITY; INDEMNIFICATION
----------------------------------------
7.1 LIMITATION OF LIABILITY
Neither PharmaBio nor its affiliates nor any of its or their respective
directors, officers, employees or agents shall have any liability whatsoever
under this Agreement or otherwise except with respect to damages directly
attributable solely to PharmaBio's negligence, gross negligence or intentional
misconduct. In addition, the collective, aggregate liability of PharmaBio and
its affiliates and its and their respective directors, officers, employees and
agents under this Agreement or otherwise shall not exceed the greater of (i) the
amount of compensation actually received by PharmaBio from the Company pursuant
to this Agreement for the assignment or task from which such liability arose or
(ii) two million ($2,000,000), except with respect to damages directly
attributable solely to PharmaBio's gross negligence or intentional misconduct.
Notwithstanding the foregoing, neither PharmaBio, nor its affiliates, nor any of
its or their respective directors, officers, employees or agents shall have any
liability for any special, incidental, or consequential damages, including, but
not limited to the loss of opportunity, loss of the use of any data or
information supplied hereunder, loss of revenue or profit, in connection with or
arising out of this Agreement, the services performed by PharmaBio hereunder or
the existence, furnishing, functioning, or the Company's use of any information,
documentation or services provided pursuant to this Agreement, even if PharmaBio
shall have been advised of the possibility of such damages.
7.2 INDEMNIFICATION
7.2.1 COMPANY
The Company shall indemnify, defend and hold harmless PharmaBio, its
affiliates and its and their respective directors, officers, employees and
agents (each, an "Indemnitee") from and against any and all losses, claims,
actions, damages, liabilities,
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costs and expenses, (including reasonable attorneys' fees and court costs)
(collectively, "Losses"), relating to or arising from or in connection with this
Agreement (including, without limitation, any Losses arising from or in
connection with any study, test, product or potential product to which this
Agreement relates) or any litigation, investigation or other proceeding relating
to any of the foregoing, except to the extent such Losses are determined to have
resulted solely from gross negligence or intentional misconduct of the
Indemnitee seeking indemnity hereunder.
7.2.2 PHARMABIO
PharmaBio shall indemnify, defend and hold harmless the Company, its
affiliates and its and their respective directors, officers, employees and
agents (each, an "Indemnitee") from and against any and all losses, claims,
actions, damages, liabilities, costs and expenses, (including reasonable
attorneys' fees and court costs) (collectively, "Losses"), to the extent caused
by PharmaBio, except to the extent (i) PharmaBio is indemnified pursuant to
Section 7.2.1 hereof OR (ii) PharmaBio's liability is excluded or limited by
Section 7.1 hereof.
7.2.3 INDEMNITOR
For purposes of Section 7.3, the party providing indemnification
pursuant to Section 7.2 shall be referred to as the Indemnitor.
7.3 INDEMNIFICATION PROCEDURE
The Indemnitee shall: (a) give the Indemnitor notice of any such claim
or law suit (including a copy thereof served upon it); and (b) Indemnitee and
its employees shall fully cooperate with the Indemnitor and its legal
representatives in the investigation of any matter the subject of
indemnification; and (c) Indemnitee shall not unreasonably withhold its approval
of the settlement of any such claim, liability, or action by the Indemnitor the
subject of this Indemnification provision and the Indemnitor may unilaterally
settle any such claim so long as the Indemnitee obtains a full and complete
enforceable release from any and all liability whatsoever from all parties
making or threatening to make the claim being settled. Provided, however, that
Indemnitee's failure to comply with its obligations pursuant to this Section 7.3
shall not constitute a breach of this Agreement nor relieve the Indemnitor of
its indemnification obligations pursuant to Section 7.2, except to the extent,
if any, that the Indemnitor's defense of the affected claim, action or
proceeding actually was materially impaired thereby.
8.0 FORCE MAJEURE
-------------
In the event PharmaBio shall be delayed or hindered in or prevented
from the performance of any act required hereunder by reasons of strike,
lockouts, labor troubles, inability to procure materials, failure of power or
restrictive government or judicial orders, or decrees, riots, insurrection, war,
Acts of God, inclement weather or any other reason or cause beyond PharmaBio's
control, then performance of such act shall be excused for the period of such
delay. If as a result of a condition or event referred to in this Section 8.0,
PharmaBio shall be unable to perform its obligations hereunder for a
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period of thirty (30) consecutive days, the Company may engage other persons to
perform services of the type contemplated by this Agreement in lieu of
PharmaBio, until such condition or event shall have ceased and PharmaBio shall
have resumed performance hereunder.
9.0 MISCELLANEOUS
-------------
9.1 INDEPENDENT CONTRACTOR RELATIONSHIP
For the purposes of this Agreement, the parties hereto are independent
contractors and nothing contained in this Agreement shall be construed to place
them in the relationship of partners, principal and agent, employer/employee or
joint venturers. PharmaBio agrees that it shall have no power or right to bind
or obligate the Company, nor shall PharmaBio hold itself out as having such
authority.
9.2 PUBLICATION
From time to time it may be to the mutual interest of PharmaBio and the
Company to publish articles relating to services performed as a part of this
Agreement. Publication of project assignment results in whole or in part, shall
be within the sole and absolute discretion of the Company. Results may not be
published or referred to, in whole or in part, without the prior expressed
written consent of the Company. The Company reserves the unqualified right to
reject any article utilizing any data generated from PharmaBio's services under
this Agreement before such article is presented or submitted for publication.
9.3 REVIEW OF WORK
During the term of this Agreement, PharmaBio will permit the Company's
representative(s) to examine the work performed hereunder and the facilities at
which the work is conducted at reasonable times and in a reasonable manner to
determine that the project assignment is being conducted in accordance with the
agreed task and that the facilities are adequate.
9.4 NOTICES
Any notice required or permitted to be given hereunder by either party
hereunder shall be in writing and shall be deemed given on the date received if
delivered personally or three days after the date postmarked if sent by
registered or certified U.S. mail, return receipt requested, postage prepaid or
by nationally recognized overnight delivery service to the following addresses:
If to PharmaBio: Gregory D. Porter, Esq.
PharmaBio Development Inc.
P.O. Box 13979
Research Triangle Park, North Carolina 27709-3979
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with a copy to: Gerald F. Roach, Esq.
Smith, Anderson, Blount, Dorsett, Mitchell &
Jernigan, L.L.P.
2500 First Union Capitol Center
Raleigh, North Carolina 27601
If to Company:
9.5 BINDING AGREEMENT; ASSIGNMENT; PARTIES IN INTEREST
This Agreement shall be binding upon and inure to the benefit of
Company and PharmaBio and their respective successors and permitted assigns.
Neither this Agreement nor any of either party's rights hereunder may be
assigned or otherwise transferred by either party without the prior written
consent of the other; provided, however, PharmaBio may in its sole discretion
assign at any time any or all of its rights and obligations under this Agreement
to any of its corporate affiliates or may utilize any such affiliates to carry
out its obligations under this Agreement. Each party hereto intends that this
Agreement shall not benefit or create any right or cause of action in or on
behalf of any person other than the Company or PharmaBio.
9.6 GOVERNING LAW; SEVERABILITY
This Agreement shall be construed, governed, interpreted, and applied
in accordance with the laws of the State of North Carolina. If any one or More
provisions of this Agreement shall be found to be illegal or unenforceable in
any respect, the validity, legality and enforceability of the remaining
provisions shall not in any way be affected or impaired thereby.
9.7 SURVIVAL
The obligations of the parties contained in Sections 5.0, 6.0, 7.0 and
9.2 hereof, shall survive the termination of this Agreement.
9.8 ENTIRE AGREEMENT
This Agreement contains the entire understandings of the parties with
respect to the subject matter herein, and supersedes all previous Agreements
(oral and written), negotiations and discussions.
9.9 AMENDMENT AND WAIVER
Neither this Agreement nor any of the terms or provisions hereof may be
(a) amended, modified or supplemented except by a written instrument signed by
both parties; or (b) waived except by written instrument signed by the party
against whom such waiver is sought to be enforced.
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9.10 GUARANTY
This Agreement shall be executed by Quintiles, Inc., a North Carolina
corporation and a wholly owned subsidiary of Quintiles Transnational Corp.
solely for the purpose of guaranteeing by such execution the payment obligations
of PharmaBio under Section 7 of this Agreement.
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IN WITNESS WHEREOF, the Company, PharmaBio and Quintiles, Inc. (solely
to the extent indicated), by authority duly given, have executed this Agreement
as of the day and year first above written.
MEDICINES DEVELOPMENT COMPANY
By: /s/ Clive A. Meanwell
---------------------------------
Name: Clive A. Meanwell
-------------------------------
Title: President
------------------------------
PHARMABIO DEVELOPMENT INC.
By: /s/ Rachel R. Selisker
---------------------------------
Name: Rachel R. Selisker
-------------------------------
Title: VP Finance
------------------------------
QUINTILES, INC., SOLELY FOR THE PURPOSE OF
SECTION 9.10
By: /s/ Rachel R. Selisker
---------------------------------
Name: Rachel R. Selisker
-------------------------------
Title: Treasurer
------------------------------
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For the purposes of agreeing and consenting to the issuance of stock by
the Company to PharmaBio as contemplated by this Agreement, the undersigned
parties hereby agree and consent to the stock issuances contemplated hereby,
with authority duly given. Without limiting the foregoing, the undersigned agree
that any such issuance of stock shall not be subject to any subscription or
participation rights provisions of the Stockholders' Agreement referred to in
the Purchase Agreement.
MEDICINES DEVELOPMENT COMPANY
By: /s/ Clive A. Meanwell
---------------------------------
Name: Clive A. Meanwell
-------------------------------
Title: President
------------------------------
PHARMABIO DEVELOPMENT INC.
By: /s/ Rachel R. Selisker
---------------------------------
Name: Rachel R. Selisker
-------------------------------
Title: VP Finance
------------------------------
WARBURG, PINCUS, VENTURES L.P.
By: /s/ James E. Thomas
---------------------------------
Name: James E. Thomas
-------------------------------
Title: Partner
------------------------------
MPM MEDICINES L.P.
By: /s/ Ansbert Gadicke
---------------------------------
Name: Ansbert Gadicke
-------------------------------
Title:
------------------------------
HANSEATIC AMERICAS LDC
By: Hansabel Partners, LLC
Managing Member
By: /s/ Paul Biddleman
---------------------------------
Name: Paul Biddleman
-------------------------------
Title: Treasurer, Hanseatic
Corporation
------------------------------
/s/ Clive A. Meanwell
------------------------------------
Clive Meanwell
/s/ T. Scott Johnson
------------------------------------
Scott Johnson
/s/ Ansbert Gadicke
------------------------------------
Ansbert Gadicke
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AMENDMENT TO ALLIANCE AGREEMENT
This Amendment to Alliance Agreement ("this Amendment"), dated this 15th
day of December, 1997, is by and between The Medicines company (formerly known
as Medicines Development Company, (the "Company")) and PharmaBio Development
Inc. ("PharmaBio").
Recitals:
The Company and PharmaBio entered into that certain Alliance Agreement,
effective August, 1996 (the "Agreement"), pursuant to which the parties agreed
to certain matters relating to PharmaBio's provision of pharmaceutical support
services. Section 1.3 of the Agreement contemplates the execution of separate
agreements to evidence project-specific engagements; however, the parties desire
to amend the Agreement to serve as a vehicle for the Company's engagement of and
contracting for one or more project with PharmaBio, as more fully set forth
herein.
Agreement:
In consideration of the mutual agreements set forth herein and other good
and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, PharmaBio and the Company hereby agree as follows:
1. AMENDMENT TO SECTION 1.3. Section 1.3 of the Agreement is hereby
amended by deleting existing Section 1.3 in its entirety and by substituting the
following in its place:
1.3 WORK ORDERS FOR PROJECT SERVICES. The following provisions shall apply
with respect to project services rendered pursuant to Section 1.2:
(a) This Agreement is intended to constitute a "master" form of contract
which allows PharmaBio and the Company to contract for multiple
projects under Section 1.2 through the issuance of multiple Work
Orders (as defined below). The specific details of each project under
Section 1.2 of this Agreement (each, a "Project") shall be separately
negotiated and specified in writing on terms and in a form acceptable
to the parties (each such writing, a "Work Order"). Each Work Order
will include, as appropriate, the Project protocol, scope of work,
timeline, budget, and payment schedule, Each Work Order shall be
subject to all of the terms and conditions of this Agreement, in
addition to the specific details set forth in the Work Order.
(b) The Company will pay PharmaBio for fees, expenses and pass-through
costs in accordance with the specific provisions of each Work Order.
Unless otherwise agreed in a particular Work Order, the following
shall apply; (a) the total fees for a particular Project will not
exceed the budget applicable to such Project and attached to the Work
Order; (b) PharmaBio shall be reimbursed by the Company for all
reasonable and necessary expenses and pass-through costs incurred in
the performance of the Services; and (c) PharmaBio will invoice the
Company monthly for the
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fees, expenses and pass-through costs relating to the Project and
payment shall be made by the Company within thirty (30) days of
receipt of each monthly itemized invoice.
(c) Any change in the details of a Work Order (including, but not limited
to, changes in the Project's scope and/or any one or number of the
duties, responsibilities and tasks undertaken by PharmaBio) shall
require a written Change Order (herein so called) in a form acceptable
to both parties. Either party may request or initiate a Change Order.
Both parties agree to act in good faith and promptly when considering
a Change Order requested by the other party and will not unreasonably
withhold approval of a requested change order.
(d) If a particular Work Order obligates PharmaBio to contract with
investigators of investigative sites (collectively, "Investigators")
or facilitate the Company's contracting with Investigators (or other
independent contractors such as central laboratories), then any such
contact shall be on a form mutually acceptable to PharmaBio and the
Company. The Company acknowledges that an Investigator engaged for a
particular Project shall be solely responsible for his or her (or its)
own independent medical judgment and his or her (or its) acts and
omissions in performing the clinical investigation and related
services.
(e) An individual Work Order under this Agreement may be terminated
without cause by the Company or by PharmaBio at any time during the
term of the Work Order on forty-five (45) days prior written notice to
PharmaBio or the Company as appropriate. An individual Work Order may
also be terminated immediately by a non-breaching party upon a
material breach of the Work Order or this Agreement by the other
party; provided, however, such termination right shall not be allowed
unless the non-breaching party provides thirty (30) days prior written
notice indicating the specific breach and the breaching party does not
cure within the thirty day notice period or initiate a cure in good
faith within the thirty day notice period and effect such cure within
sixty days after expiration of the thirty day notice period. In the
event a Work Order is terminated other than a result of breach by
PharmaBio, the Company's sole obligation to PharmaBio with respect to
the impacted Project(s) shall be (a) to pay PharmaBio any fees for
Services rendered through the termination date, and (b) to pay all
actual costs to complete activities associated with the termination
and close out of Projects.
(f) The Company agrees that PharmaBio may utilize the Services of its
corporate affiliates to fulfill PharmaBio's obligations under this
Agreement and any Work Order. Any affiliate so utilized shall be (i)
subject to all of the terms and conditions applicable to PharmaBio
under this Agreement and the Work Order applicable to such Project(s),
including, but not limited to, provisions establishing the standards
for performance, and (ii) entitled to all rights and protections
afforded PharmaBio under this Agreement and the Work Order applicable
to such
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<PAGE> 16
Project(s), including, but not limited to, the indemnity and
limitation of liability protections set forth herein. Any such
affiliate of PharmaBio may execute a Work Order directly and, with
respect to the corresponding Project, the rights and obligations of
the parties shall be governed by all of the terms and conditions of
this Agreement, to the same extent as if such affiliate was a party to
this Agreement.
(g) The standards, rights and obligations of the parties set forth in
Sections 1.4, 2, 3, 4, 5, 6, 7, 8, and 9 of this Agreement shall be
applicable to every Work Order performed under this Agreement, unless
the Work Order expressly and specifically states an intent to
supersede this Agreement on a specific matter (but the only with
respect to such matter and the specific Work Order).
2. CORRESPONDING AMENDMENTS. Any provisions in the Agreement in conflict
with this Amendment with respect to the ability to issue Work Orders for
Projects under the Agreement shall be deemed superseded by this Amendment.
3. EFFECT ON THE AGREEMENT. The Company and PharmaBio acknowledge that
the Agreement (as amended hereby) (i) is in full force and effect and shall
control PharmaBio's provision of services and the related rights and obligations
of PharmaBio and the Company with respect to Projects, and (ii) shall continue
to control the rights and obligations of the Company and PharmaBio with respect
to the original matters addressed therein.
4. COUNTERPARTS. This Amendment may be executed in multiple counterparts,
all of which taken together shall constitute on agreement.
The parties have executed this Amendment effective as of the date first
written above.
THE MEDICINES COMPANY PHARMABIO DEVELOPMENT INC.
By: /s/ Clive A. Meanwell By: illegible
--------------------------------- ----------------------------------
Name: Clive A. Meanwell Name:
------------------------------- -------------------------------
Title: President Title:
------------------------------ -------------------------------
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