Exhibit 10.8
RESEARCH, DEVELOPMENT AND MARKETING AGREEMENT
This RESEARCH, DEVELOPMENT AND MARKETING AGREEMENT ("AGREEMENT") is
made
effective as of December 9, 2003 ("Effective Date"), by and between
Luitpold
Pharmaceuticals, Inc., a New York corporation ("Luitpold") and
BioMimetic
Pharmaceuticals, Inc., a Delaware corporation ("BMPI") (each,
individually, a
"Party" and, collectively, the "Parties").
WHEREAS, BMPI has developed technology involving GEM 21
(Growth-factor
Enhanced Matrix) products containing recombinant human platelet
derived growth
factor (rhPDGF-BB) and a bone matrix (collectively the "Licensed
Products"), and
holds licensed and other rights to certain United States and
foreign patents
related to the Licensed Products;
WHEREAS, BMPI is currently conducting clinical studies in an effort
to
obtain approval of the Licensed Products for uses related to the
treatment,
cure, or relief of humans for periodontal diseases by the U.S. Food
and Drug
Administration ("FDA") and Canadian regulatory authorities, and
obtaining the CE
mark in the European Union, and also holds certain licensed and
other patent
rights for uses related to the treatment, cure, or relief of
mammals for
periodontal diseases and/or the repair, restoration or
reconstruction of oral
and cranio-maxillofacial osseous defects (the "Field of Use") and
uses outside
the Field of Use that are related to the treatment and healing of
bone,
cartilage, tendon and ligaments of the skeletal system in animals
(excluding
humans), excluding the treatment and healing of soft tissue wounds,
(the "Field
of Extended Use");
WHEREAS, Luitpold has an interest in marketing the Licensed
Products in the
Field of Use and Field of Extended Use worldwide once approval has
been obtained
in the United States and a "CE" mark is obtained in the European
Union in the
Field of Use, and Luitpold therefore has an interest in the
successful
completion of the approval process; and
WHEREAS, both Luitpold and BMPI consider it desirable to perform
and
complete the regulatory approval process for the Field of Use;
NOW, THEREFORE, the Parties hereto agree as follows:
1.
RESEARCH AND DEVELOPMENT. BMPI agrees to continue the clinical
studies and
shall make commercially reasonable efforts to complete the clinical
studies
and regulatory filings required to obtain FDA marketing approval in
the
United States and applicable regulatory approval in the E.U. and
Canada for
the Licensed Products in the Field of Use (the "Initial
Approvals"),
including any and all postmarketing or other studies required as a
condition of the Initial Approvals. Where shelf life of rePDGF-BB
in the
Field of Use may be extended, BMPI will conduct such extended
stability
studies as may be required by a regulatory authority or authorities
for
such shelf life extension. BMPI shall pay all costs incurred by it
in
connection with completing all such studies and fees associated
with such
filings.
2.
REPORTING. At least quarterly after the execution of this
Agreement, BMPI
shall meet with representative of Luitpold to review the progress
of the
clinical development and status of regulatory approvals of the
Licensed
Products.
3.
MARKETING. Upon execution of this Agreement, BMPI shall assist
Luitpold
with marketing activities with respect to the Licensed Products.
These
activities shall include:
a.
reviewing advertising materials prepared by Luitpold;
b.
introducing Luitpold to key opinion leaders in the Field of Use;
c.
assisting Luitpold in the identification and selection of potential
distribution partners in Europe;
d.
assisting Luitpold in the design and conduct of clinical trials for
additional label claims in the United States and the European
Union;
and
e.
assisting Luitpold in the design and conduct of post-marketing
clinical studies.
All clinical studies for additional label claims and/or
post-marketing
purposes, not required as a condition of the Initial Approvals,
shall be at
the sole cost and expense of Luitpold. The parties acknowledge and
agree
that no external marketing activities will be undertaken before the
date of
regulatory approval, except for such activities as allowed by law.
The parties agree, that as provided in that certain Supply
Agreement
between BMPI and Orthovita Inc. dated August 2, 2002, Orthovita
shall have
the right to review and recommend modifications to all testing
protocols
for the pre-clinical studies and the clinical studies prior to the
commencement of each individual study of Licensed Products
containing
beta-TriCalcium Phosphate ("beta-TCP"). In addition, Jeffery
Hollinger,
Ph.D. shall direct the pharmacokinetic study portion of the
pre-clinical
studies of Licensed Products containing beta-TCP.
4.
FUNDING.
a.
R&D. Luitpold shall pay to BMPI, upon execution of this
Agreement, the
sum of ** to compensate BMPI for the cost of product development
incurred to date, as well as future costs of completing the
clinical
trial(s) and any and all postmarketing or other studies required as
a
condition of the Initial Approvals.
b.
REGULATORY AND MARKETING ASSISTANCE. Luitpold shall pay to BMPI the
sum of ** within thirty (30) days after the date on which the CE
mark
for Licensed Products in the Field of Use is first received in any
jurisdiction in the European Union to pay for preparation,
submission
and prosecution of regulatory filings as well as for Marketing
assistance as set forth in Section 3, during the initial marketing
of
the Licensed Products in the European Union. Luitpold acknowledges
that the Licensed Products are experimental in
2
**
REPRESENTS MATERIAL WHICH HAS BEEN REDACTED AND SEPARATELY FILED
WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL
TREATMENT PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS
AMENDED.
nature, and are currently being used solely for research purposes
and
in clinical studies to obtain FDA and Canadian approvals and the CE
mark in the European Union. Luitpold understands that no
warranties,
express or implied, are given concerning the approval of the
Licensed
Products and no assurances can be given that the Licensed Products
will receive FDA or other governmental approval, or the CE mark.
5.
INVENTIONS AND PATENTS.
a.
Any and all Improvements (as such term is defined in the Exclusive
Sublicense Agreement) to the Licensed Products shall be governed by
the terms of the Exclusive Sublicense Agreement defined in Section
8
hereof.
b.
Luitpold may not claim by virtue of this Agreement (other than
rights
granted pursuant to the Exclusive Sublicense Agreement) any right
title or interest in (a) any issued or pending patents owned or
controlled by BMPI or (b) any invention, process or product arising
out of BMPI's previous research and development activities, whether
or
not patentable. Each Party shall cooperate with the other in
matters
of patent protection consistent with the terms and conditions of
this
Agreement.
6.
EQUIPMENT/PROTOTYPES. BMPI shall retain title to all equipment
purchased by
it with funds provided by Luitpold to complete the clinical
studies, to
make regulatory filings, to conduct rese
