EXHIBIT 10.9
STRATEGIC ALLIANCE AND REPRESENTATION AGREEMENT
This Agreement ("Agreement") is made as of the 29th day of March, 2000
by SFBC/Pharmaceutical Development Associates, Inc. ("PDA") a Florida
corporation and ClinSites/LeeCoast Research Center Inc. ("LRC") a Florida
corporation.
INTRODUCTION
PDA, directly and through an independent contractor, is in the business
of marketing clinical research services to pharmaceutical manufacturing
companies, distributors, clinical research organizations, and pharmaceutical
consultants (collectively, the "Industry" or individually, a "Sponsor") related
to branded generic and generic and pharmaceutical Studies (as defined below) and
specialty formulation companies (the "Market").
For purposes of this Agreement, a "Study" or "Studies" means any
clinical research study and/or related bioanalytical analysis for a Sponsor or
member of the Industry related to the Market.
LRC has certain clinical research experience and personnel available
which are necessary for the conduct of Studies with a particular emphasis on
Studies related to single site clinical efficacy and safety trials,
vasocontrictor and BA/BE studies; provided, however, that this specialty
emphasis shall not be interpreted to limit or alter in any way the definition of
"Study" or "Studies" as used herein.
PDA desires to represent LRC on a worldwide basis for the purpose of
placement of Studies at LRC for certain companies in the Market which are listed
on Schedule A (the "Customers").
LRC desires that PDA accept the appointment as its representative for
marketing Studies, all upon the terms and conditions more specifically set forth
herein.
NOW, THEREFORE, the parties hereto agree as follows with the intent to
be legally bound hereby:
1. APPOINTMENT. LRC hereby appoints PDA and PDA agrees to accept such
appointment to represent LRC as its marketing representative for
Studies generated from Customers, subject to the terms and conditions
set forth below.
2. SERVICES TO BE RENDERED BY PDA. PDA will use its best efforts to
promote the business of LRC with respect to Studies in a manner that
will preserve the goodwill and reputation of LRC, which duties shall
include, but not be limited to, the following:
a. PDA will advise LRC in developing a marketing plan for
generating Studies, which will include sales goals, individual
Sponsor objectives and individual assignments to achieve the
objectives. In addition sales calls/visit reports will be
submitted to LRC by PDA within five (5) business days of their
occurrence.
b. PDA shall generate responses to proposal requests
("Proposals") for Studies from Sponsors. Proposals shall be in
writing and shall describe the work to be performed for the
Sponsor. The single site operation portion of the Proposal
shall be presented by PDA to LRC, on a right of first refusal
basis, if possible, at least thirty (30) days prior to the
proposed start date of the Study. All Proposals shall be
approved by LRC in writing (which shall include email) prior
to submission to a Sponsor.
c. PDA will maintain a project tracking list for all potential
and contracted Studies.
d. The single site operation portion of all Proposals shall be
placed with LRC unless final terms (pricing or timing) are not
acceptable to the Sponsor or LRC declines to bid on a
Proposal; provided, however, that LRC shall be given three (3)
business days to modify any terms to comply with a Sponsor's
requirements before the Study can be placed elsewhere.
e. In the event that LRC cannot reasonably complete its duties
under an agreement within the time frame required by a
Customer, PDA may utilize a competitor of LRC (including an
affiliate of PDA) to assist LRC or complete the study.
3. SERVICES TO BE RENDERED BY LRC. LRC will grant PDA the exclusive
marketing arrangement as described in paragraph 1 for Customers. Once a
Proposal has been presented to LRC by PDA, LRC may either reject the
Proposal or agree to it within 3 days. If accepted, contracts between
LRC and the Sponsor or between PDA and LRC for PDA managed projects,
shall be completed by LRC. LRC shall use its best efforts to complete
the resulting Study in accordance with the contract related thereto.
4. WORLDWIDE CLIENTS. This Agreement applies to the Customers. In the
event PDA subcontracts all or part of a Study to LRC, PDA shall have
all rights and obligations applying to Sponsors, as set forth in this
Agreement with respect to Studies and as generally prevalent in the
Industry.
5. PAYMENT FOR SERVICES
a. LRC - In full payment for its services, LRC shall receive the
fees set forth in the contract between LRC and the Sponsor for
the Study (including PDA managed projects for which PDA is
Sponsor).
b. PDA - In full payment for its services, PDA shall be paid
commission payments based on the amount of money actually
collected by LRC under its contracts for Studies, as invoiced
(defined as total payments minus credits relating to any Study
or Studies for which any amount has been collected) which are
initiated and negotiated by PDA for LRC and as follows:
i. PDA managed Studies.
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Type of Project
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Phase II, III, IV Single Site Clinical 3% of Total Revenue
Equivalence Efficacy Studies
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Phase I 3% of Total Revenue
Bioequivalence/Bioavailability
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Phase II, III, IV Multi Site Efficacy 3% of Total Revenue
Studies
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Dermal Safety and Pharmaco Dynamic 3% of Total Revenue
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Vasoconstrictor Studies 2% of Total Revenue
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ii. Projects with the Sponsor contracted directly by LRC.
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Type of Project
---------------------------------------- ---------------------------------------
Phase II, III, IV Single Site Efficacy 5% of Total Revenue
Studies
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Phase I 5% of Total Revenue
Bioequivalence/Bioavailability
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Phase II, III, IV Multi-Site Efficacy 5% of Total Revenue
Studies
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Dermal Safety and Pharmaco 5% of Total Revenue
Dynamic Studies
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Vasoconstrictor Studies 4% of Total Revenue
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iii. PDA's commission payments shall be earned at the end
of the month in which such payments are collected by
LRC from the Sponsors. Payments are due to PDA by the
10th of the month following the month collected.
c. Expenses and Benefits. PDA shall pay all of its own expenses,
including but not limited to, office space, travel and
entertainment expenses, secretarial assistance, office
supplies and benefits, except that LRC shall pay reasonable
travel expenses for PDA employees and consultants for trips
specifically requested by LRC. PDA shall market LRC services
at all appropriate conferences and exhibits. LRC is
responsible for all promotional material and prorated expenses
for US conferences or exhibits it wishes to attend as a
co-exhibitor.
6. TERM OF AGREEMENT. This Agreement shall commence on the date hereof and
shall continue until March 31, 2003 or until terminated by either party
in accordance with the following provisions:
a. This Agreement may be terminated by mutual written consent at
any time.
b. If an Event of Default occurs (as defined in paragraph 12),
this Agreement may be terminated by the non-defaulting party
within 30 days of its receipt of written notice, unless such
Event of Default is cured within the 30 day period.
c. Except as described in paragraph 6d. below, this Agreement may
be terminated by either party after the = first anniversary of
the signing of the Agreement upon one hundred and eighty (180)
days' prior written notice to the other party.
d. In the event that a third party (or parties) acquires control
of LRC (or purchases all or substantially all of LRC's assets)
and that third party (or parties) is (i) not owned or
controlled by SFBC International, Inc., (ii) not owned or
controlled by the management of LRC or (iii) owned or
controlled by an individual or group of individuals or
entities which have been directly engaged in the business of,
among other things, operating single site Phase I clinics
which provide services to the Market (for example, MDS Xxxxxx,
MDS Phoenix, PMRI, Biovial, PPD, Anapharm, Pracs and
Pharmakinetics are currently engaged in this business), then
PDA may terminate this Agreement upon 30 days' written notice.
e. In the event of any termination, whether in case of an Event
of Default or not, the parties agree that (i) any fees earned
prior to the effective date of termination shall be paid in
full, (ii) any Study under contract or in process in the
laboratory shall be completed and commission paid as payments
received by LRC, and (iii) all other rights and obligations
hereunder shall cease, except for confidentiality in paragraph
7, including any rights of first refusal and exclusivity.
7. CONFIDENTIALITY.
a. For the purposes of this Agreement "Confidential Information"
with regard to LRC shall mean any written information relating
the business of LRC that has not been previously released by
duly authorized representatives of LRC, and shall include but
not be limited to the following: studies under contract,
marketing plans, protocols, financial information, assays,
formulations, test results, computer programs and any
information about Study participants.
b. For purposes of this Agreement, "Confidential Information"
with regard to PDA shall mean any written information relating
to the business of PDA that has not been previously released
by duly authorized representatives of PDA and shall include
but not be limited to the following: pharmaceutical companies
with whom PDA has an exclusive relationship,
c. LRC and PDA agree not to disclose the Confidential Information
of the other to any individual or entity, in any manner,
directly or indirectly, during the term of this Agreement or
thereafter. Each party may, however, disclose Confidential
Information to their employees, agents, and/or consultants,
and to Sponsors with a need to know in order to conduct the
business described hereunder. Otherwise, the release of
Confidential Information shall require the prior written
consent of an authorized officer of PDA or LRC, as the case
may be.
d. In the event this Agreement is terminated, the parties agree
to promptly return all of the other's Confidential Information
upon request.
e. The provisions of paragraph 7 shall survive termination of
this Agreement for a period of 5 years.
8. EXCLUSIVITY AND RIGHT OF FIRST REFUSAL.
a. As partial consideration for this Agreement, PDA agrees to
provide LRC with a right of first refusal for all Studies
arising from the companies listed on Schedule A, including,
without limitation,
i. Phase II, III, IV Single Site Efficacy Studies
ii. Phase I, BA/BE Studies
iii. Dermal Safety and Pharmaco Dynamic Studies
(Vasoconstrictor)
b. LRC agrees that in the event a Sponsor not in Attachment 1
requests a proposal directly from LRC for a managed project or
clinical efficacy safety study that LRC does not have the
capability to under take, LRC shall refer the Sponsor to PDA
and shall inform PDA of such referral. PDA will pay LRC a
commission for such projects as listed in paragraph 5.b.ii.
9. ENTIRE AGREEMENT, AMENDMENT. This Agreement constitutes the entire
Agreement between the parties in connection with the subject matter
hereof, and supersedes all prior and contemporaneous understandings of
the parties. This Agreement may not be modified or amended except by an
agreement in writing signed by both parties, and consented to by
Pacific Capital, L.P.
10. INDEPENDENT CONTRACTOR. The parties agree that PDA will act as an
independent contractor pursuant to this Agreement and that nothing
herein shall create an agency, partnership, joint venture or other
relationship between PDA and LRC. Furthermore, PDA understands and
agrees that it has no authority to make or imply any commitments which
are binding upon LRC and agrees that it will act only at LRC's
direction.
11. GOVERNING LAW. This Agreement shall be governed by the laws of the
State of Florida.
12. DEFAULT. Either party hereto shall be considered to have committed an
"Event of Default" under this agreement if it (i) fails to comply in
any material respect with the terms and conditions of this Agreement
(ii) discloses any Confidential Information of the other, except as
permitted by paragraph 8; (iii) breaches any of the exclusivity and
right of first refusal provisions of paragraph 7.
13. ASSIGNMENT. This Agreement and the rights and obligations hereunder may
not be assigned by either party to any other entity without the written
approval of both parties.
A change in the controlling equity ownership of either party shall not
be deemed an assignment.
14. NOTICES. All notices and other communications required or permitted
under this Agreement shall be in writing and shall be deemed received
if sent by certified or registered mail, return receipt requested, or
by a nationally recognized overnight carrier, prepaid to the following
addresses:
If to LeeCoast Research Center:
0000 Xxxxx Xxxxxx, Xxxxx 000
Xx. Xxxxx, Xxxxxxx 00000
Attention: Xxxxxx Xxxxxxxx
If to PDA:
0000 Xxxxxxx Xxxxx Xxxx
Xxxxxxxxx, Xxxxx Xxxxxxxx 00000
Attention: D. Xxxxx Xxxxx
IN WITNESS WHEREOF, the parties hereto have signed this Agreement as of
the date written above.
LEECOAST RESEARCH CENTER
By: /s/ Xxxxxx X. Xxxxxxxx
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Name: Xxxxxx X. Xxxxxxxx
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Title: President
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SFBC/PDA
By: /s/ Xxxxxx Xxxxxxx
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Name: Xxxxxx Xxxxxxx
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Title: Vice-President
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SCHEDULE A
Customers
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AAI Duramed
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Academic Pharm Dynagen
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ALKO Xxxxxx & Associates
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Alpharma Effcon
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Alra Elan Transdermal
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Xxxxxx Xxxx
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Alza Endo Pharmaceuticals
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American Generics Xxxx Pharmaceuticals
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Amide Eon
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Anabolic Eye Dynamics
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Andrx Ferndale
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Xxxxxx Xxxxxx Consulting
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Apheresis Technology, Inc. Ferring Pharmaceuticals
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Apotex Forest
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Apothecon Futura Medical
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Ascent Pediatrics G&W
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Banaker Consultling Geneva
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Banner Pharmacaps GenPharm
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Xxxx Labs GG Group
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Bausch & Lomb Gilead Sciences
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Beach Products, Inc. Global
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Bertek Globomax
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Beta Derm Great Nations
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Biocryst Xxxxxx
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Biovail Harmony
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Xxxxxx Health HiTech
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Capricorn Horizon
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Capsugel Ilex Oncology
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Caraco Pharmaceutical Invamed
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Carlsbad Ivax
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Catalytica Pharmaceuticals Kali
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CB Fleet KOS
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Ceptyr Inc KV
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Ciba Vision Xxxxxxxx
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Cima Labs Lavipharm
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Clay Park Lilly
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Clonmel Mallinckrodt
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Concord labs Martec
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Xxxxxx Merck Generic
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Xxx Labs, Inc. Midlar
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DPT Mikart
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Dupont/Merck Miran Consulting
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Dupont Pharmaceutical ScandiPharm
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Xxxxxx Grove Pharm. Seatrace
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Xxxx Xxxxx
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MTRA Sidmail
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Mylan Solvay
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NeoTherapeutics, Inc. Somerset Pharmaceutical
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Noven Pharmaceuticals Sovereign
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Novopharm Staason
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Oakwood Xxxxxxxx
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Ocumed Taro
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Optime Teva
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P-3 Consulting Thames
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P.D.M. Pharmatec, Inc. Time Caps
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Paddock UCB Pharma
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Par Pharmaceutical Unigen
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Perrigo Union Springs
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PFI Xxxxxx Xxxxx Labs, Inc.
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Pharma Science Valley Forge Pharmaceuticals
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Pharmaconsult Versapharm
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Pharmalogix, Inc. Xxxxxx-CA
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Pharmatec Xxxxxx-Florida
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Purdue Pharmaceutical Westward
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Purepac Wockhardt
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RanBaxy ZARS
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Rosemont Zenith
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Xxxxxxx
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Rx-Otc Consultants
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