EXHIBIT 10-11
ORAPHARMA, INC.
Xx. Xxxxxx Xxxxxxx
Technical Developments and Investments, Est.
X/X Xxxxxxxxxx X.X.
Xxx xxx Xxxxxxxx 00
1000 Xxxxxxxx 0, Xxxxxxxxxxx
Re: OraPharma, Inc.
Dear Xx. Xxxxxxx,
Reference is made to the Agreement dated June 26, 1986 (the "Agreement") by and
---------
between American Cyanamid Company, a Maine corporation ("ACY") and Technical
---
Developments and Investments Est., a Liechtenstein corporation ("TDI").
---
Pursuant to the terms of the Agreement, ACY has granted to TDI and TDI's
associated companies, Debiopharm and Cytotech (collectively with TDI, the
"Debiopharm Companies"), a worldwide non-exclusive license (the "License") to
--------------------- -------
use certain technology and patents (together, the "Technology") for certain
----------
purposes.
The Debiopharm Companies hereby grant to OraPharma, Inc., a Delaware corporation
("OraPharma"), an exclusive, world-wide sublicense to use the Technology
---------
(including the right to grant sublicenses to third-parties) in the oral cavity.
By the term "exclusive" in this context, both parties mean that the Debiopharm
Companies will not grant a license to use the Technology in the oral cavity to
third parties nor use it in the field of the oral cavity. The Debiopharm
Companies hereby jointly and severally represent and warrant to OraPharma that
they have not exercised any of their rights with respect to the Technology in
the oral cavity and that they have not granted any rights related to the
Technology to any third-party, that they will not grant such rights to third
parties and that they are hereby in a position to grant such rights to
OraPharma. The Debiopharm Companies further covenant and agree that they will
not exercise or grant such rights and will not take any action to conflict with
or interfere with the rights to be granted to OraPharma by ACY pursuant to that
certain license agreement relating to the Technology to be entered into between
OraPharma and ACY. The Debiopharm Companies do not warrant that the American
Cyanamid Company has not granted any right to the Technology in the oral cavity
to any third party.
In consideration of the foregoing, OraPharma agrees to pay to the Debiopharm
Companies a royalty in U.S. Dollars (the "Royalty") equal to [the confidential
-------
material contained herein has
ORAPHARMA, INC.
been omitted and has been separately filed with the Commission] products which
use the Technology in the oral cavity (the "Products"). For purposes of this
--------
letter agreement, "Revenues" means all gross revenues actually received by
--------
OraPharma from its sale of Products, less any taxes, insurances, transportation
costs, duties and similar costs and expenses and less any credits,
disallowances, deductions and returns actually allowed by OraPharma to its
customers; provided, however, that with respect to sales made by OraPharma to
-----------------
any affiliate of OraPharma, or sales made by any subsidiaries of OraPharma,
Revenues shall be the higher of (a) the amount calculated in accordance with the
foregoing, or (b) Revenues received by such affiliate or by such sub-licensee in
connection with its sale of the Product to its customer.
Royalty payments shall be paid by OraPharma to the Debiopharm Companies within
sixty (60) days after the end of each of OraPharma's fiscal quarters and shall
be based on the Revenues of such previous fiscal quarter. All Royalty payments
shall be made by check mailed to the Debiopharm Companies or by wire transfer to
a bank as specified from time to time by the Debiopharm companies. Beginning
with OraPharma's fiscal quarter following its first commercial sale of Products,
OraPharma shall deliver to the Debiopharm Companies a Royalty report within
sixty (60) days after the end of each fiscal quarter. Such report shall set
forth the total Royalty payments for the fiscal quarter most recently ended,
with explanation of how such Royalty payments were calculated and any
adjustments made. The Debiopharm Companies, through its representatives, shall
have the right, at the Debiopharm Companies' cost and expense and upon
reasonable notice, to inspect, during normal business hours, the accounting
books and records of OraPharma solely for the purpose of verifying the amount of
Royalty payments due to the Debiopharm Companies pursuant to this letter
agreement. Such representatives shall be subject to a confidentiality agreement
that provides, among other things, a limitation on the amount and type of
information which he or it may reveal to any third-parties, including the
Debiopharm Companies.
This letter agreement will be governed by the laws of the State of New Jersey.
Please confirm your agreement to this letter agreement by executing the enclosed
extra copy in the space provided below and returning it to me.
Sincerely,
/s/Xxxxxxx Xxxxxxxxx
Xxxxxxx Kishbachu[sic]
President & CEO
OraPharma, Inc.
Agreed to and accepted by DEBIOPHARM
By: [signature illegible]
-----------------------------------------
Date: February 13, 1997
---------------------------------------
Agreed to and accepted by DEBIO R.P.
By: [signature illegible]
-----------------------------------------
Date: February 13, 1997
---------------------------------------
AGREEMENT
---------
THIS AGREEMENT effective as of the 26th day of June, 1986, by and between
the AMERICAN CYANAMID COMPANY, a corporation organized under the laws of the
State of Maine, having executive offices at Xxx Xxxxxxxx Xxxxx, Xxxxx, Xxx
Xxxxxx, 00000 (hereinafter referred to as "CYNAMID") and TECHNICAL DEVELOPMENTS
AND INVESTMENTS EST., a corporation organized under the laws of Liechtenstein,
having offices at Xxx xx Xxxxx-Xxxxx 00 in Lausanne, Switzerland (hereinafter
referred to as "T.D.I.") represented by Xxxxxxx-Xxxx Mauvernay, Scientific
Manager.
WITNESSETH
----------
WHEREAS, T.D.I. and CYANAMID entered a Licensing Agreement dated June 29th,
1983, as amended on September 27th, 1983 (hereinafter "The Agreements") and have
reached mutually agreed conditions for the termination thereof;
NOW, THEREFORE, in consideration of the following terms and undertakings of
each party hereto, the parties agree to terminate The Agreements:
1) CYANAMID hereby agrees to file an Investigational New Drug
Application (hereinafter "I.N.D.") for [the confidential material
contained herein has been omitted and has been separately filed
with the Commission] or as soon thereafter as CYANAMID can
accomplish such filing. A list of the documents to be included in
the I.N.D. package have been provided to T.D.I.
CYANAMID agrees to promptly supply a free copy of the I.N.D.
documents to T.D.I. and to give T.D.I. the exclusive rights to
assign such an I.N.D. to another party which T.D.I. will identify
and designate to CYANAMID in the near future. CYANAMID further
agrees to answer any questions that the F.D.A. may raise on such
an I.N.D. in the normal course of F.D.A. practice and to
facilitate the orderly transfer of information and development
activities for [the confidential material contained herein has
been omitted and has been separately filed with the Commission]
to another party designated by T.D.I. Upon such transfer, the
party designated by T.D.I. shall be responsible for the I.N.D.
2) CYANAMID agrees to continue to supply the polymer needed for the
microencapsulation of [the confidential material contained herein
has been omitted and has been separately filed with the
Commission] to T.D.I., its associated companies DEBIOPHARM and
CYTOTECH and their licensees for a reasonable period of time in
order not to disrupt the current development of [the confidential
material contained herein has been omitted and has been
separately filed with the Commission] at a price and under
specifications similar to those prevailing at the time of
termination.
3) CYANAMID agrees to sell to T.D.I. or its designated party the
amount of certified [the confidential material contained herein
has been omitted and has been separately filed with the
Commission] in its possession
at the cost price paid by CYANAMID, on request.
4) CYANAMID agrees to maintain all records and data in its
possession related to the toxicology studies included in the
I.N.D., according to accepted Good Laboratory Practices for the
Statutory period needed, and to allow T.D.I. or its designated
party free access to such data as needed.
5) CYANAMID further agrees to carry to completion the current
stability studies on [the confidential material contained herein
has been omitted and has been separately filed with the
Commission] and likewise to transfer such stability data to
T.D.I. or its designated party on request.
6) CYANAMID is in possession of a delivery system which is of
interest to T.D.I. in preparing [the confidential material
contained herein has been omitted and has been separately filed
within the Commission.] CYANAMID shall provide information
related to such technology to T.D.I. in writing and will include
CYANAMID Know-How and CYANAMID proprietary and patent
information, if any, and hereby grants to T.D.I. (and associated
companies DEBIOPHARM and CYTOTECH) a royalty-free worldwide non-
exclusive license to use such technology and any CYANAMID patents
thereon for the manufacture of and delivery of [the confidential
material contained herein has been omitted and has been
separately filed with the Commission] and other products which
DEBIOPHARM independently develops or is manufacturing under a
third-party license, with sublicensing privileges and with
CYANAMID
retaining title to such information, patents and Know-How,
including the right to practice such patented inventions, for
products other than [the Confidential material contained herein
has been omitted and has been separately filed with the
Commission.], but CYANAMID specifically agrees not to use such
delivery system or license third parties (other than T.D.I.) to
use such delivery system for products which are [the confidential
material contained herein has been omitted and has been
separately filed with the Commission] (as defined by Chemical
Abstracts as being [the confidential material contained herein
has been omitted and has been separately filed with the
Commission]) for a period of seven years from the effective date
of this Agreement.
7) In consideration of the above covenants, The Agreements are
hereby discharged and terminated.
AMERICAN CYANAMID COMPANY TECHNICAL DEVELOPMENT AND INVESTMENTS EST.
By: /s/Xxxx Xxxxxx By: [signature illegible]
------------------------------ ---------------------------------
Name:Xxxx Xxxxxx Name:
Executive
Vice President Date:
