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
xxxx 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" xxxx 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, Xxxxxxx Xxxxxxxxx,
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 xxxx
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
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** 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
xxxx 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 xxxx.
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 research, and to manufacture the
Licensed Products.
7. GOVERNMENT APPROVALS. BMPI shall assist Luitpold by reasonably supplying to
Luitpold appropriate data, documents and other information necessary to
enable Luitpold to obtain any necessary governmental or other approval for
marketing the Licensed Products in the Field of Use outside the United
States, the European Union and Canada or in the Field of Extended Use
worldwide, or needed with respect to any post-marketing clinical studies
for the Licensed Products for which Luitpold is responsible.
8. EXCLUSIVE SUBLICENSE AGREEMENT. On the Effective Date, Luitpold and BMPI
agree to enter into an Exclusive Sublicense Agreement with respect to the
Licensed Products in substantially the form attached hereto as Exhibit A.
9. MANUFACTURING AND SUPPLY AGREEMENT. On the Effective Date, Luitpold and
BMPI agree to enter into a seven (7) year Manufacturing and Supply
Agreement with respect to the production of the Licensed Products in
substantially the form attached hereto as Exhibit B.
10. CONFIDENTIALITY. Because BMPI and Luitpold will be cooperating with each
other in this Agreement and because each may reveal to the other in the
course of this Agreement certain confidential information, Luitpold and
BMPI agree to hold any confidential and proprietary information of the
other Party confidential pursuant to the provisions of the Nondisclosure
Agreement between the Parties dated as of April 28, 2003.
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11. RESPONSIBILITY. The Parties each agree to assume individual responsibility
for the actions and omissions of their respective employees, agents, and
assigns in conjunction with this Agreement.
12. DEFAULT AND TERMINATION. The term of this Agreement shall be for a period
beginning on the Effective Date and extending until the fifth (5th)
anniversary from the date Luitpold makes the payment set forth in Section
4(b). In the event that one Party commits any material breach of this
Agreement, the non-breaching Party may terminate this Agreement at its
option by giving the breaching Party not less than sixty (60) days written
notice of its election to terminate as of a stated date. Such notice shall
state the nature of the defaults claimed by the non-breaching Party. The
breaching Party during said sixty (60) day period may cure any default
stated in said notice and if such default is cured or, if such default is
not a failure to pay an amount due and will reasonably take longer than
sixty (60) days to cure and the breaching Party is diligently pursuing such
cure, this Agreement shall continue in full force and effect as if such
notice had not been given. Additionally, any breach of the Exclusive
Sublicense Agreement described in Section 8 hereof or the Manufacturing and
Supply Agreement described in Section 9 hereof shall also be deemed a
breach of this Agreement. Termination of this Agreement shall not affect
the rights and obligations of the Parties which accrued prior to the
effective date of termination.
13. GENERAL PROVISIONS.
a. Limited Liability. EXCEPT IN THE CASE OF GROSS NEGLIGENCE OR WILLFUL
MISCONDUCT, NEITHER LUITPOLD NOR BMPI WILL BE LIABLE WITH RESPECT TO
ANY MATTER ARISING UNDER THIS AGREEMENT UNDER ANY CONTRACT,
NEGLIGENCE, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR
(A) ANY PUNITIVE, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES OR
LOST PROFITS OR (B) COST OF PROCUREMENT OF SUBSTITUTE GOODS,
TECHNOLOGY OR SERVICES.
b. Use of Name. Luitpold does not have, and shall not acquire, any
interest in any of BMPI's trademarks or trade names unless otherwise
expressly agreed by BMPI in writing. BMPI's name may appear on the
packaging and labeling for the Licensed Products and in material
included therewith to the extent required by law; provided, however,
that each such use must be approved in writing by BMPI, which approval
shall not be unreasonably withheld. Luitpold shall not otherwise use
the name of BMPI, or disclose the existence of this Agreement for any
marketing, advertising or promotional purpose, without BMPI's prior
written consent.
c. No Agency. Nothing herein contained shall be deemed to create an
agency, joint venture, amalgamation, partnership or similar
relationship between BMPI and Luitpold. Notwithstanding any of the
provisions of this Agreement, neither Party shall at any time enter
into, incur or hold itself out to third Parties as having authority to
enter into or incur, on behalf of the other Party, any commitment,
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expense or liability whatsoever, and all contracts, expenses and
liabilities undertaken or incurred by one Party in connection with the
performance of its obligations under this Agreement shall be
undertaken, incurred or paid exclusively by that Party, and not as an
agent or representative of the other Party. The Parties hereto agree
that each is acting as an independent contractor and not as an agent
or partner of the other by virtue of this Agreement.
d. Severability. If any provision of this Agreement shall be found to be
void, invalid or unenforceable, the same shall either be conformed to
the extent necessary to comply with applicable law or stricken if not
so conformable, so as not to affect the validity of this Agreement.
e. Notices. All notices, requests, demands, waivers, consents, approvals
or other communications hereunder shall be in writing and shall be
deemed to have been duly given if delivered personally, or by a
recognized commercial courier service, and delivered by facsimile
transmission as follows:
If to BMPI: BioMimetic Pharmaceuticals, Inc.
000 Xxxxxxx Xxxxxxx, Xxxxx X-0
Xxxxxxxx, XX 00000
Attention: President and CEO
FAX: 000-000-0000
With a copy to: Xxxxxxx Xxxxxx Xxxx Xxxxxxx & Manner, P.C.
000 Xxxxxxxxx Xxxxxx, Xxxxx 0000
Xxxxxxxxx, XX 00000
Attention: Xxxx Manner
FAX: 000-000-0000
If to Luitpold: Luitpold Pharmaceuticals, Inc.
Xxx Xxxxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: President and CEO
FAX: 000-000-0000
With a copy to: Xxxxxxxxxxxx Xxxx & Xxxxxxxxx LLP
0000 X Xxxxxx, X.X.
Xxxxx 000, Xxxx Xxxxx
Xxxxxxxxxx, XX 00000
Attention: Xxxxx X. Xxxxxxxxx
FAX: 000-000-0000
or to such other address as the addressee may have specified in a notice duly
given to the sender as provided herein. Such notice, request, demand, waiver,
consent, approval or other communication will be deemed effective (a) as of the
date so delivered either personally or by facsimile transmission or courier
service; or (b) on the third (3rd) business day after the same has been mailed.
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(f) Force Majeure. Neither Party to this Agreement shall be liable for
delay or failure in the performance of any of its obligations hereunder if such
delay or failure is due to causes beyond its reasonable control, including,
without limitation, acts of God, fires, earthquakes, strikes and labor disputes,
acts of war and threatened acts of war, acts of terror and threatened acts of
terror, civil unrest, or intervention of any governmental authority, but any
such delay or failure shall be remedied by such Party as soon as is reasonably
possible. If the force majeure event persists for longer than twelve (12)
months, the other Party shall have the right to terminate this Agreement.
(g) Assignments. This Agreement may not be assigned by Luitpold without the
written prior consent of BMPI; provided Luitpold may assign this Agreement to an
acquiror of all or substantially all of its assets. This Agreement shall inure
to the benefit of and be binding on the Parties' permitted assigns, and
successors in interest.
(h) Waivers and Modifications. The failure of any Party to insist on the
performance of any obligation hereunder shall not act as a waiver of such
obligation. No waiver, modification, release, or amendment or any obligation
under this Agreement shall be valid or effective unless in writing and signed by
both Parties hereto.
(i) Choice of Law. This Agreement is subject to and shall be construed and
enforced in accordance with the laws of the State of Tennessee without reference
to its choice of law provisions.
(j) Dispute Resolution. The Parties agree that prior to any arbitration
concerning this Agreement, an executive officer of BMPI and Luitpold with
authority to resolve the dispute will meet within ten (10) days of a written
request by either Party to the other and will attempt in good faith to negotiate
a resolution to the dispute. If the Parties are unable to negotiate a resolution
to the dispute within twenty (20) days of commencing negotiations, either Party
may initiate arbitration proceedings by written request to the other. Except as
otherwise specifically provided herein, all controversies and claims under this
Agreement shall be settled by binding arbitration by a panel of three (3)
arbitrators pursuant to the Commercial Arbitration Rules of the American
Arbitration Association. The arbitration shall be conducted in New York, New
York. Each Party shall select one arbitrator and the two arbitrators so selected
shall jointly select a third arbitrator. The decision reached by the arbitrators
shall be conclusive and binding upon the Parties hereto and may be filed with
the clerk of any court of competent jurisdiction. Each of the Parties shall pay
its own expenses of arbitration and the expenses of the arbitrators shall be
equally shared. Notwithstanding anything to the contrary in this Section (j),
either Party may seek immediate injunctive relief from any court of competent
jurisdiction for the protection of its intellectual property or Confidential
Information.
(k) Headings. Section headings are for convenience only and will not be
deemed to affect in any way the language of the provisions to which they refer.
(l) Execution. This Agreement shall be executed in duplicate, both of which
shall be deemed to be originals, and both of which shall constitute one and the
same agreement.
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(m) Entire Agreement. This Agreement constitutes the entire agreement
between the Parties as to the subject matter hereof, and all prior negotiations,
representations, agreements and understandings are merged into, extinguished by
and completely expressed by this Agreement.
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IN WITNESS WHEREOF, BMPI and Luitpold have entered into this Agreement effective
as of the date first hereinabove written.
LUITPOLD PHARMACEUTICALS, INC. BMPI PHARMACEUTICALS, INC.
By: /s/ Xxxx Xxxx Xxxxxxx By: /s/ Xxxxxx X. Xxxxx
------------------------------------ ---------------------------------
Name: Xxxx Xxxx Xxxxxxx Name: Xxxxxx X. Xxxxx
Title: President, CEO Title: President
By: /s/ Xxxx X. Xxxxxx
------------------------------------
Name: XXXX X. XXXXXX
Title: VICE PRESIDENT, OHD
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EXHIBIT A
EXCLUSIVE SUBLICENSE AGREEMENT
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EXHIBIT B
MANUFACTURING AND SUPPLY AGREEMENT
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