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LICENSE AGREEMENT
PERIOSTAT(R)
BETWEEN
COLLAGENEX PHARMACEUTICALS, INC
&
COLLAGENEX INTERNATIONAL LIMITED
AND
LABORATOIRES PHARMASCIENCE S.A.
Dated and effective this 30th day of June 1998
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KNOW-HOW AND LICENSE AGREEMENT
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This KNOW-HOW AND LICENSE AGREEMENT (hereinafter "the Agreement") is made and
effective the 30th day of June 1998 by and between COLLAGENEX PHARMACEUTICALS,
INC a company organised and existing under the laws of the State of Delaware,
USA and having a place of business at 301 South State Street, Newtown,
Pennsylvania 18940, USA through its affiliate company COLLAGENEX INTERNATIONAL
LIMITED a company registered and existing under the laws of England and having
its registered office at The Old Stable Block, 7 Buttermarket, Thame,
Oxfordshire OX9 3EW, United Kingdom (hereinafter collectively "CollaGenex") and
LABORATOIRES PHARMASCIENCE S.A. a company organised and existing under the laws
of the Republic of France and having a place of business at 73 Boulevard de la
Mission Marchand, F - 92402 Courbevoie Cedex, France (hereinafter "Licensee")
WITNESSETH:
WHEREAS CollaGenex has developed and has rights to the Products as defined
herein and desires to grant a License to Licensee to market and sell the
Products in the Territory as defined herein and on the terms set forth herein;
and
WHEREAS Licensee desires to License the rights to the Products as defined herein
from CollaGenex for the purposes of marketing and selling the Products in the
Territory;
NOW, THEREFORE, in Consideration of the premises and the mutual covenants and
agreements hereinafter contained, the parties hereto, intending to be legally
bound, hereby undertake and agree as follows:-
1. DEFINITIONS
1.1. The term "Affiliate" shall mean any entity in which the party has a
direct or indirect ownership of at least fifty per cent (50%), or any
entity which directly or indirectly, through one or more intermediaries,
controls, or is controlled by, or is under common control with the
party.
1.2. The term "Commercial Sale" shall mean any sale which transfers title to
any Product, as defined herein, to a third party. Transfer of title to
an Affiliate of Licensee shall not constitute a Commercial Sale unless
such Affiliate is the intended end user of the Product.
1.3. The term "Confidential Information" shall mean any and all information
or any portion thereof disclosed to or otherwise acquired or observed by
either party or its employees,
agents or Affiliates (each individually referred to as a "Recipient")
either directly or indirectly from the other party, including, but not
limited to, the Products and/or improvements, enhancements,
modifications, discoveries, claims, formulae, processes, apparatuses,
research, development, patents, Confidential Information, Know-how,
trade secrets, knowledge, designs, drawings, specifications, concepts,
data, reports, methods, documentation, methodology, pricing, marketing
plans, customer lists, salaries or business affairs, and any other
information or knowledge owned or developed or controlled by either
party, except for information which the Recipient can demonstrate:-
1.3.1. was at the time of disclosure to such Recipient part of the public
domain or thereafter becomes part of the public domain through no act or
omission by such Recipient; or
1.3.2. was lawfully in such Recipient's possession as evidenced by written
records prior to disclosure by the disclosing party and without any
obligation of confidentiality; or
1.3.3. was lawfully received by such Recipient after disclosure from a third
party without obligation of confidentiality and without violation by
said third party of any obligation of confidentiality to another party;
or
1.3.4. was required to be disclosed by law or court order.
1.4. The term "Improved Products" shall mean any major improvements to the
Products based on sub antimicrobial doses of doxycycline hyclate as an
inhibitor of collagenolytic activity for use in the treatment of any
form of periodontal disease. Examples of Improved Products include, but
may not be limited to (a) a once a day formulation of the Products (b)
any improvement resulting in patentable subject matter in the Territory.
A change in the salt for the product formulation as defined in Clause
1.7. hereof shall not constitute an Improved Product.
1.5. The term "Know-how" shall mean all data and information concerning the
Products.
1.6. The term "Net Sales" of the Products shall mean the gross invoice price
received and attributable to the Commercial Sale of the Products in the
Territory by Licensee or by an Affiliate of Licensee; less returns,
promotional allowances, import or export taxes, any tax or Governmental
charge levied on the sale, transportation or delivery of such Products
and borne by the seller thereof, commissions to third parties and
customary trade discounts actually taken.
1.7. The term "the Products" shall mean Periostat(R), the doxycycline
hyclate product developed by CollaGenex as a therapy for the treatment
of periodontal disease.
1.8. The term "the Territory" shall mean France, including its Departements
et Territories d'Outre-Mer ("DOM-TOM"); Morocco, Algeria, Tunisia and
the other countries of French speaking Africa.
1.9. The term "Gross Margin" shall mean the difference between the Net Sales
price of the Products and the price paid by the Licensee to the
manufacturer of the Products plus any transport, duty or local taxes
incurred for the Licensee to receive the Products in its warehouse.
2. LICENSES AND OTHER RIGHTS
2.1. GRANT OF LICENSES. Subject to the limitations described below,
CollaGenex hereby grants to Licensee an exclusive License to use the
Know-how and an exclusive License to use, sell and distribute the
Products in the Territory. Licensee shall have no right to transfer,
assign or sub-license any of its rights hereunder to any third party,
other than Affiliates of Licensee, for any purposes, without the express
written consent of CollaGenex.
2.2. EXCLUSIVITY OF LICENSE. All exclusive licenses granted to Licensee
hereunder will be exclusive as to CollaGenex and all others. CollaGenex
shall retain title to, and be the owner of, any and all Confidential
Information.
2.3. PROHIBITED TRANSFERS. During the term of this Agreement, CollaGenex
agrees that, without Licensee's express written consent, CollaGenex will
not assign, sell, convey, lease, license, transfer, hypothecate,
encumber or suffer imposition of any lien on, grant any right or
interest in, or disclose to any third party in the Territory any of the
Confidential Information concerning the Products save as may be required
to obtain marketing authorisations for the Products in the Territory.
Licensee shall not disclose any Confidential Information furnished by
CollaGenex pursuant to Clause 2.1. hereof to third parties during the
term hereof, or any extension hereto, or at any time thereafter,
provided, however, that disclosure may be made of any such Confidential
Information to the extent necessary to market the Products to
purchasers; provided that such purchasers agree to be bound to a similar
non disclosure agreement. Licensee shall not use any Confidential
Information furnished by CollaGenex other than in the marketing of the
Products in the Territory and only during the term of this Agreement and
any extension hereto.
2.4. SUPPLY OF PRODUCTS. During the term hereof, and any extension hereto,
Licensee may either (a) purchase the Products for resale by Licensee in
the Territory from a European manufacturer licensed and/or approved by
CollaGenex and approved by the relevant regulatory bodies and/or holding
the relevant, current manufacturing certificates or approvals in the
country of manufacture to manufacture the Products and/or (b) purchase
the Products from another European source, approved in advance by
CollaGenex, such source to comply with all regulatory requirements for
the manufacture of the Products and for such manufacture to be carried
out under a confidentiality agreement. The terms and conditions for
supply of the Products shall be agreed upon by Licensee and such third
party manufacturers independent of CollaGenex. Relevant commitments from
the European manufacturing source to Licensee shall be attached to
this Agreement as Appendix I, such Appendix I to be attached to this
Agreement within thirty (30) days of the effective date hereof.
CollaGenex will render all reasonable assistance to Licensee in
procuring supply of the Products for sale in the Territory. Licensee
shall be responsible for ensuring that all of the Products sourced from
a third party manufacturer shall be of merchantable quality and
otherwise manufactured in accordance with applicable law. Licensee may,
at its discretion, be permitted to source the Products from another
Licensee of CollaGenex, upon terms to be agreed between such Licensees,
provided that the other terms and conditions of this Clause 2.4. shall
be complied with. Other than as defined in Clause 12 hereof, the failure
of a manufacturing source to supply the Products to Licensee resulting
in Licensee having an out of stock situation that lasts up to three (3)
months shall not be cause for termination of this Agreement by
CollaGenex.
2.5. RIGHTS TO IMPROVED PRODUCTS. CollaGenex agrees to notify Licensee, in
writing, of any Improved Products in a reasonably timely manner. Unless
prevented by virtue of other licensing agreements with other licensees,
CollaGenex agrees to grant Licensee a "right of first refusal" for
ninety (90) days from the date of notification of the Improved Products
to negotiate a license agreement under reasonable commercial terms to
obtain (a) an exclusive right and license to use, sell and distribute
Improved Products in the Territory and (b) an exclusive right and
license under patents applicable to the Territory, if any, to use, sell
and distribute Improved Products in the Territory.
2.6. GOVERNMENT SUBMISSIONS. CollaGenex shall use all reasonable efforts to
obtain the applicable marketing authorisations for the Products in the
Territory from the relevant authorities, save where such applications
are made, by prior agreement, by Licensee; and to maintain such
marketing authorisations during the term hereof and any extension
hereto. CollaGenex shall be the owner and party of record sponsoring all
submissions to the regulatory authorities in the Territory with respect
to the Products and to the Improved Products. CollaGenex will furnish
Licensee with all Know-how and relevant documentation required by the
regulatory authorities in the Territory to allow Licensee to use, sell
and distribute the Products in the Territory.
Upon the request of CollaGenex, Licensee shall provide reasonable local
technical and local market knowledge assistance to CollaGenex and/or any
professional advisors to CollaGenex which shall include, but may not be
limited to, contract research and contract regulatory and similar
organisations; in obtaining and maintaining the marketing
authorisations.
2.7. COMMERCIAL INFORMATION. CollaGenex shall use its reasonable commercial
efforts to furnish Licensee with all commercial information in
CollaGenex's possession which may include, but may not be limited to;
market research data; marketing plans; sales plans; promotional
activities; conferences; seminars; exhibitions and the like in which
CollaGenex and/or Affiliates of CollaGenex and/or licensees of
CollaGenex outside of the Territory may be involved or concerned, and
relating to the Products, in English; within a reasonable period of such
commercial information becoming available
to CollaGenex and which may reasonably be required by Licensee in order
for Licensee to fulfil its obligations hereunder. Licensee understands
and agrees that such commercial information may constitute Confidential
Information hereunder. Licensee shall be responsible for obtaining all
local commercial and pricing authorisations for the marketing of the
Products in the Territory in accordance with the regulations pertaining
to the Territory and shall keep CollaGenex or an Affiliate of CollaGenex
fully informed with regard to progress in obtaining such local
commercial and pricing authorisations.
3. LICENSING FEES AND ROYALTY PAYMENTS
3.1. MILESTONE PAYMENTS AND RUNNING ROYALTIES. In consideration of the
License granted under this Agreement, Licensee agrees to pay to
CollaGenex the following milestone payments at the time intervals
specified:-
3.1.1. The sum of $400,000.00 (four hundred thousand US dollars) upon the
signing of this Agreement, less any sums that may have been paid in
advance.
3.1.2. The sum of * US dollars) upon the
submission of the dossier for the marketing authorisation to the
relevant authorities in France or the submission of the dossier under
the European Mutual Recognition Procedure to a number of countries which
shall include France.
3.1.3. The sum of * US dollars) upon the
granting of the marketing authorisation in France whether or not this
shall have been obtained via direct submission to the French authorities
or under the European Mutual Recognition Procedure.
3.1.4. The sum of * US dollars)
upon the earlier of either (a) the granting of the lesser of (i) a
reimbursed price with a Gross Margin of at least *
or (ii) mutually agreed commercially acceptable pricing and
reimbursement price approvals by the Commission de Transparence and the
Comite Economique in France, or (b) the introduction of the Products in
the French market within the French medicines reimbursement system in
accordance with the provisions of Clause 8.5. hereof.
In addition, a running royalty will be paid in accordance with the
following terms:-
3.1.5. If the approved price in France shall generate a gross margin of *
or more to Licensee, a sum equivalent to *
of the Net Sales for the term of this Agreement or any extension
hereto; or
3.1.6. * plus * of the difference between
the Gross Margin and * with a minimum of *
and a maximum of * .
* Confidential information has been omitted and filed separately with the
Securities and Exchange Commission.
3.2. REPORTS AND PAYMENTS. Payments pursuant to Clauses 3.1.1., 3.1.2.,
3.1.3. and 3.1.4. inclusive hereof will be paid by Licensee to
CollaGenex, by a method designated by CollaGenex, within thirty (30)
days of the milestone or other event specified therein.
No payment shall be due in accordance with the provisions of Clause
3.1.1. hereof if, within thirty (30) days of the effective date of this
Agreement, the parties have met with an Expert Rapporteur to the French
Medicines Agency and have mutually agreed that there is no reasonable
probability of acceptance by the French Medicines Agency of an
application for a marketing authorisation in France and this Agreement
shall immediately terminate save as for the provisions of this Agreement
that shall survive termination.
Licensee undertakes and agrees to notify CollaGenex, in writing, within
seven (7) days of the commercial and pricing approvals specified in
Clause 3.1.4. hereof being obtained. Payments pursuant to Clauses 3.1.5.
and 3.1.6. hereof, as applicable, will be paid, as directed by
CollaGenex, within fifteen (15) days after the end of each calendar
quarter during the term hereof or any extension hereto with respect to
the applicable Net Sales made by Licensee and/or any Affiliate of
Licensee during each calendar quarter.
With each quarterly payment, Licensee will provide CollaGenex with a
written report stating the actual Net Sales made by the Licensee and/or
any Affiliate of Licensee during such prior calendar quarter and the
amount of royalties due to CollaGenex thereon pursuant to this Clause 3.
The minimum payment shown in Clause 10.3. hereof shall be payable
annually after calculation against the actual royalties remitted and any
shortfall remitted, in a manner to be designated by CollaGenex, within
thirty (30) days of the end of such quarter.
The parties have the option to mutually agree, at an appropriate time,
for royalties to be remitted in the European currency "the Euro" (or
such other designation as may be given to a common European currency)
provided that the parties have agreed an exchange rate, subject to the
terms above, of the Euro against the currency in which royalties had
been previously remitted or would have been remitted.
3.3. RECORDING AND INSPECTION. Licensee agrees that for a period of three (3)
years after delivery of each report referred to in Clause 3.2. above, it
shall keep at its principal place of business complete records of
applicable Net Sales received by Licensee and/or any Affiliate of
Licensee and all other information necessary to permit Licensee to
verify the accuracy of the calculations of Net Sales, and to make
regular entries in such records at its earliest business convenience for
the purpose of determining the Net Sales as defined herein.
For the sole purpose of verifying Licensee's performance of its
obligations to make payments hereunder, CollaGenex, solely through its
certified public accountant or authorised representative thereof or
other independent third party designee, will have the right to examine
Licensee's records reflecting such Net Sales and other information,
provided that such examination is made within three (3) years after the
close of the
calendar year in respect of which Licensee's records are being examined,
conducted within Licensee's normal business hours, made after thirty
(30) days advance written notice to Licensee and limited to no more than
one examination in any one calendar year. The results of such
examination shall be made available to both parties. CollaGenex shall
bear the full cost of the performance of such examination, unless such
examination discloses a variance of more than two per cent (2%) from the
amount of the original report or payment calculation. In such case,
Licensee shall bear the full cost of the performance of such examination
and Licensee shall promptly pay to CollaGenex any variance disclosed in
such examination.
3.4. CURRENCY OF PAYMENT. All payments shall be made in United States dollars
(US$). Royalty payments in United States dollars pursuant to Clauses
3.1.5. and 3.1.6 hereof shall be translated at the rate of exchange at
which United States dollars are listed in the Wall Street Journal
against the French franc, or, as applicable, the Euro; at an average of
the daily rate during the calendar quarter in which Net Sales are
received by Licensee or by an Affiliate of Licensee.
3.5. METHOD OF PAYMENT. All payments shall be made in accordance with the
provisions of Clause 3.2. hereof by Direct Wire Transfer or other
generally accepted method of Bank to Bank currency transfer, all charges
to account of drawer, to an account of CollaGenex's definition and at
the sole discretion of CollaGenex.
4. TRADEMARK MATTERS
4.1. Licensee shall be permitted to use the trade mark "Periostat" in styles
and formats to be designated solely by CollaGenex for the marketing,
selling, advertising and distribution of the Products in the Territory.
4.2. Registration of the trade mark, maintenance and protection of such trade
mark, and all costs associated therewith shall be the sole
responsibility of CollaGenex.
4.3. Licensee shall promptly notify CollaGenex, in writing, in the event of
any infringement of the trade mark, or potential infringement of the
trade mark, in the Territory coming to its attention, or the attention
of one of its Affiliates, and shall assist CollaGenex, to the extent
requested and/or directed by CollaGenex, in protecting the trade mark in
the Territory.
5. REPRESENTATIONS WARRANTIES AND COVENANTS OF THE PARTIES
5.1. REPRESENTATIONS AND WARRANTIES OF COLLAGENEX. CollaGenex hereby
represents and warrants to Licensee that:-
5.1.1. it is a corporation duly organised, validly existing and in good
standing under the relevant laws of the State of Delaware, United States
of America and of England and has full corporate power and authority to
own its properties and to conduct the business in which it is now
engaged;
5.1.2. it has full corporate power and authority to execute and deliver this
Agreement and to perform all of its obligations hereunder, and no
consent or approval of any other person or Governmental authority is
required therefor. The execution and delivery of this Agreement by
CollaGenex; the performance by CollaGenex of its covenants and
agreements hereunder and the consummation by CollaGenex of the
transactions contemplated hereby have been duly authorised by all
necessary corporate action. This Agreement constitutes a valid and
binding obligation of CollaGenex, enforceable against it in accordance
with its terms;
5.1.3. neither the execution nor the delivery of this Agreement, nor the
consummation of the transactions contemplated hereby, violate any
provision of the Certificate of Incorporation or the Memorandum and
Articles of Association or Bye-Laws of CollaGenex or any law, statute,
ordinance, regulation, order, judgement or decree of any Court or
Governmental agency; or conflicts with or results in any breach of any
of the terms of or constitutes a default under or results in the
termination of or the creation of any lien pursuant to the terms of any
contract or agreement to which CollaGenex is a party or by which any of
the assets of CollaGenex is bound; and
5.1.4. CollaGenex has no knowledge of, and has received no notice of, any claim
of ownership or other adverse interest of any third party with respect
to the Products or the Confidential Information.
5.2. REPRESENTATIONS AND WARRANTIES OF LICENSEE. Licensee hereby warrants and
represents to CollaGenex that:-
5.2.1. it is a corporation duly organised, validly existing and in good
standing under the laws of the Republic of France and has full corporate
power and authority to own its properties and to conduct the business in
which it is now engaged.
5.2.2. it has full corporate power and authority to execute and deliver this
Agreement and to perform all of its obligations hereunder, and no
consent or approval of any other person or Governmental authority is
required therefor. The execution and delivery of this Agreement by
Licensee; the performance by Licensee of its covenants and agreements
hereunder and the consummation by Licensee of the transactions
contemplated hereby have been duly authorised by all necessary corporate
action. This Agreement constitutes a valid and legally binding
obligation of Licensee, enforceable against it in accordance with its
terms; and
5.2.3. neither the execution and delivery of this Agreement, nor the
consummation of the transactions contemplated hereby, violates any
provision of the organisational or governing documents of Licensee nor
any law, statute, ordinance, regulation, order, judgement or decree of
any Court or Governmental agency, or conflicts with or results in any
breach of any of the terms of or constitutes a default under or results
in the termination of or the creation of any lien pursuant to the terms
of any contract or agreement to which Licensee is a party or by which
any of the assets of Licensee is bound.
5.2.4. it will comply in all respects with the legal requirements of the
Territory relating to the sourcing, storage, marketing, sale and
distribution of the Products.
6. INDEMNIFICATION
6.1. INDEMNIFICATION BY THE PARTIES. Each of the parties hereto will
indemnify the other party from and against any and all losses, claims,
demands, obligations, liabilities, costs, expenses or damages of any
kind or nature (collectively "Damages"), including, but not limited to,
reasonable fees of attorneys; accountants and other professionals,
incurred by the indemnified party as a result of any claim or proceeding
brought against the indemnified party by any person not a party to this
Agreement, to the extent that such claim or proceeding is based on any
of the representations or warranties contained in this Agreement being
untrue or upon breach of any of the provisions of this Agreement;
provided that the indemnified party promptly notifies the indemnifying
party of any such claim or proceeding in writing and gives the
indemnifying party the opportunity to defend or settle such claim or
proceeding. The indemnified party agrees to co-operate with the
indemnifying party, at the indemnifying party's expense, in defending or
settling such claim or proceeding.
6.2. PRODUCT INDEMNIFICATION. Licensee agrees to defend, indemnify and hold
harmless CollaGenex from any and all Damages arising from injury or
damage to persons or property (including, without limitation, product
liability) resulting directly or indirectly from Licensee's sourcing,
storage, marketing, sale and distribution of the Products in the
Territory. CollaGenex warrants to Licensee that all data submitted by
CollaGenex to the appropriate regulatory authority in France or in any
other country where CollaGenex has applied for or may apply for
marketing authorisations are an accurate representation of clinical
trial and other data, to the best of CollaGenex's knowledge and belief,
as warranted by CollaGenex to the appropriate regulatory authorities.
7. CONFIDENTIALITY
7.1. CONFIDENTIALITY. Except to the extent expressly authorised by this
Agreement or otherwise agreed in writing, the parties agree that, for
the term of this Agreement any extension thereto and for a period of
seven (7) years thereafter, the Recipient shall keep completely
confidential and shall not publish or cause to be published or otherwise
disclose and shall not use for any purposes any Confidential Information
furnished to it by the other party or developed pursuant to this
Agreement; provided, however, that after the expiration or termination
of this Agreement, or any extension hereto, either party shall be free
to exploit commercially in any manner any proprietary information and
technology which belongs solely or jointly to it.
7.2. AUTHORISED DISCLOSURE. Each party may disclose Confidential Information
of the party to its employees, agents and Affiliates who (a) are
required to know such information in connection with the permitted use
of such information hereunder and who (b) are bound by customary non-use
and confidentiality obligations as set forth in this Clause 7.
7.3. BUSINESS TERMS. The parties acknowledge and agree that the financial
terms contained in Clause 3 of this Agreement shall be considered as
Confidential Information hereunder. The parties further agree that
publication of the existence of this Agreement may be of significant
commercial value to each party and the parties agree to allow the
publication of press releases announcing the Agreement by either party,
but only following approval by both parties of the content of such press
releases, or as required by law.
8. TERM AND TERMINATION AND REVERSION OF TECHNOLOGY
8.1. TERM. The term of this Agreement shall be for a period of fifteen (15)
years from the date of first Commercial Sale of the Products in the
Territory and shall thereafter be extended for consecutive five (5) year
terms unless either party shall give the other written notice of
termination eighteen (18) months prior to the end of the applicable
term.
8.2. MUTUAL TERMINATION. The parties hereto may terminate this Agreement by
mutual written consent. Such termination shall be effective sixty (60)
days after such a determination or upon such other date as the parties
may mutually agree.
8.3. TERMINATION RELATED TO REGISTRATION. The parties agree that gaining the
necessary marketing authorisation for the Products in France is pivotal
to this Agreement. CollaGenex agrees to keep Licensee informed regarding
the progress towards necessary regulatory approvals but neither party
shall be liable to the other in the event of delays directly relating to
the actions of a regulatory authority and neither party shall have the
right to terminate this Agreement in relation to regulatory timeframes
except in accordance with Clause 8.2. hereof. CollaGenex undertake and
agree that the dossier will be submitted to the appropriate authorities
in France either direct or via the European Mutual Recognition Procedure
within three years of the effective date of this Agreement.
8.4. TERMINATION OF LICENSE WITHOUT CAUSE. Licensee may terminate this
Agreement and revert its rights to source, use, market, sell and
distribute the Products in the Territory under this Agreement at any
time upon * days written notice to
CollaGenex. Such reversion shall be free of any continuing lien on, or
grant of any right or interest in, the Products or the Confidential
Information. In the event of such termination, no further payments
relating to the milestones specified in Clauses 3.1.2., 3.1.3. and
3.1.4. hereof relating to the Products shall accrue or be due under this
Agreement subsequent to the effective date of such termination;
provided, however, that Licensee shall pay to CollaGenex any royalties
accrued on Net Sales prior to the effective date of the termination of
the License under this Clause 8.4.
8.5. TERMINATION BY FAILURE OF LICENSEE TO MARKET. CollaGenex shall have the
right to terminate this Agreement should Licensee fail to initiate and
maintain for the term of this Agreement an active marketing, sales and
distribution programme and launch the Product in France within
* days of written advice from CollaGenex that the
marketing authorisation has been granted and/or written advice from
Licensee to CollaGenex in accordance with Clause 3.1.4. hereof that the
reimbursement
* Confidential information has been omitted and filed separately with the
Securities and Exchange Commission.
price has been published in the "JOURNAL OFFICIEL", or Licensee has
received official notification that reimbursement for the Products will
not be granted, whichever shall be the later.
8.6. BREACH OF MATERIAL OBLIGATIONS. Failure by either party to comply with
any of the material obligations contained in this Agreement shall
entitle the other party to give to the party in default notice
specifying the nature of the default and requiring such party to remedy
such default. If such default is not remedied within ninety (90) days
(or, if the default cannot be remedied within such ninety day period and
the party in default does not commence and diligently continue actions
to remedy such default), the notifying party shall be entitled, without
prejudice to any of its other rights conferred on it by this Agreement,
to all remedies available to it by law or in equity, including, without
limitation, the termination of this Agreement.
8.7. INSOLVENCY OR BANKRUPTCY. Either party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement
by written notice to the other party in the event the other party shall
have become insolvent or bankrupt, or shall have made an assignment for
the benefit of its creditors, or there shall have been appointed a
trustee or receiver of the other party for all or a substantial part of
its property, or any case or proceeding shall have been commenced or
other action taken by or against the other party in bankruptcy or
seeking re-organisation, liquidation, dissolution, winding-up
arrangement, composition or re-adjustment of its debts or any relief
under any bankruptcy, insolvency, re-organisation or other similar act
or law of any jurisdiction now or hereafter in effect, or there shall
have been issued a warrant of attachment, execution or distraint or
similar process against any substantial part of the property of the
other party, and any such event shall have continued for sixty (60) days
undismissed, unbonded and undischarged.
8.8. RIGHT TO SELL STOCK ON HAND. Upon the termination of the License granted
hereunder for any reason other than a failure to remedy a material
breach of this Agreement by Licensee, Licensee shall have the right to
complete all work in progress and for one year (or such longer period as
the parties may reasonably and mutually agree) to dispose of all of the
Products then on hand by way of normal trade sales in the Territory, and
royalties shall be paid to CollaGenex with respect to such sales of the
Products as though such License had not terminated or expired.
8.9. EFFECT OF TERMINATION. In the event of termination of this Agreement,
except as otherwise provided for herein; all rights to the Products and
the Confidential Information shall revert to CollaGenex who shall be
free to develop, license or otherwise exploit the Products and the
Confidential Information in the Territory as it deems appropriate and
Licensee shall (a) take whatever steps are reasonably necessary and
appropriate to revert to CollaGenex all rights in the Products and the
Confidential Information in the Territory and (b) return to CollaGenex
all information relating to the Products and the Confidential
Information without retaining any copies or extracts therefrom save as
may be required to identify the obligations of Licensee under this
Agreement and (c) make no further use of
any of the Confidential Information and (d) take whatever steps are
reasonably necessary and appropriate to transfer to CollaGenex or its
designees all submissions to regulatory authorities (or any part
thereof) in the Territory and (e) to immediately cease to use the Trade
Marks and in the event that (contrary to the intention of CollaGenex)
the Licensee has acquired any rights in or over the trade marks to
transfer the same, unencumbered, to CollaGenex and (f) to take no
actions that would in any way have a negative effect on the sales of the
Products in the Territory.
8.10. SURVIVING RIGHTS. Any termination under this Agreement shall be without
prejudice to the rights and remedies of either party with respect to any
provisions of this Agreement or arising out of breaches prior to such
termination and shall not relieve either of the parties of any
obligation or liability accrued hereunder prior to such termination,
including, without limitation, indemnity obligations, nor rescind or
give rise to any right to rescind anything done or any payments made or
other consideration given hereunder prior to the time of such
termination and shall not affect in any manner any vested rights of
either party arising out of this Agreement prior to such termination.
9. NON COMPETE CLAUSE
Licensee shall not, during the term of this Agreement, or any extension
hereto, or for a period of two (2) years after the expiration or
termination of this Agreement, or any extension hereto; manufacture,
cause to have manufactured by a third party on its behalf, market, sell
or distribute any other products containing low dose doxycycline hyclate
as a therapy for periodontal disease.
10. BEST ENDEAVOURS AND MINIMUM PERFORMANCE
10.1. Licensee shall, during the term of this Agreement and any extension
hereto, use its best endeavours to develop the sales of the Products in
the Territory.
10.2. Within sixty (60) days of the signing of this Agreement, Licensee shall
provide to CollaGenex, for approval by CollaGenex, a forecast of sales
of the Products in the Territory, such forecast to attach to and form
part of this Agreement as Appendix II, for each of the three years
following the date of first Commercial Sale of the Products in the
Territory and this Schedule II will be updated by Licensee on an annual
basis, in accordance with Licensee's own business and budget planning
process, and such updates will include the following years so that at
all times CollaGenex shall have a three year forecast of sales of the
Products in the Territory. Such forecasts shall reasonably reflect
actual historical Commercial Sales and Commercial Sales trends, if any.
Prior to first Commercial Sale, any changes to Schedule II shall be
subject to the approval of CollaGenex. Such schedule, in the agreed
format of Appendix II, shall be furnished by Licensee to CollaGenex by
no later than the 1st January of each calendar year for the term of this
Agreement and any extension hereto.
10.3. Upon the acceptance by CollaGenex of Schedule II to this Agreement (as
described in Clause 10.2. hereof) there shall be *
during the first twelve (12)
* Confidential information has been omitted and filed separately with the
Securities and Exchange Commission.
month period from date of first Commercial Sale of the Products in the
Territory. In the second twelve (12) month period from date of first
Commercial Sale of the Products in the Territory, the Minimum
Performance as defined in this Clause 10.3. shall be *
of the most recent forecast for such period. Commencing with the
third twelve (12) month period from the date of first Commercial Sale of
the Products in the Territory, and for each twelve (12) month period
thereafter, a sum equivalent to * of the most
recent forecast for such period shall be agreed as the Minimum
Performance of Licensee for such period, hereinafter "the Minimum
Performance".
In the event of the actual Net Sales of Licensee, as defined herein,
being less than the Minimum Performance, then Licensee shall have the
right to pay the royalty as defined in Clauses 3.1.5. and 3.1.6. hereof
based on the Minimum Performance as defined herein in order to retain
its rights under this Agreement, failing which CollaGenex shall have the
right to terminate this Agreement in accordance with the provisions
hereof.
11. MISCELLANEOUS PROVISIONS
11.1. FURTHER ASSURANCES. The parties hereto agree to execute and deliver such
other documents, instruments and agreements and to take such other
actions as may be necessary, proper or appropriate to carry out the
terms of this Agreement.
11.2. NOTICES. All notices required or permitted under this Agreement shall be
in writing and delivered by any method providing proof of delivery. Any
notice shall be deemed to have been given on date of receipt. Notices
shall be delivered to the parties at the following addresses until a
different address has been designated by notice to the other party:
If to CollaGenex: CollaGenex Pharmaceuticals, Inc.,
301 South State Street,
Newtown,
Pennsylvania 18940,
United States of America.
Attention: Robert A. Ashley
CollaGenex International Limited,
The Old Stable Block,
7 Buttermarket,
Thame,
Oxfordshire OX9 3EW,
United Kingdom.
Attention: David A. Pettit
* Confidential information has been omitted and filed separately with the
Securities and Exchange Commission.
with copies to: Buchanan Ingersoll,
College Center,
500 College Road East,
Princeton,
New Jersey 08540,
United States of America.
Attention: David J. Sorin
If to Pharmascience: Laboratoires Pharmascience S.A.,
73 Boulevard de la Mission Marchand,
F - 92402 Courbevoie Cedex,
France.
Attention: Gerald VIEUILLE
11.3. COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which shall be deemed an original, but all of
which taken together shall constitute one and the same instrument.
11.4. RECORDATION. If either CollaGenex or Licensee so requests in writing,
the parties will promptly file and record with any applicable office or
authority, a copy or memorandum of this Agreement and any other
agreement granting Licensee rights in the Products and in the
Confidential Information.
11.5. ENTIRE AGREEMENT, MODIFICATIONS. This Agreement contains the entire
agreement between the parties hereto with respect to the subject matter
hereof, and no modification, amendment, change or supplement shall be
effective unless in writing and signed by the authorised officers of the
parties. This Agreement supercedes all prior understandings,
negotiations and agreements, whether written or oral, relating to the
subject matter hereof.
11.6. WAIVER. The waiver by either party of a breach or default of any of the
provisions contained herein shall be in writing and shall not be
construed as a waiver of any succeeding breach or default or of the
provision itself.
11.7. EXPENSES. Except as may be otherwise provided for in this Agreement,
each of the parties hereto shall bear such party's own expenses in
connection with this Agreement and the transaction contemplated hereby.
11.8. GOVERNING LAW. This Agreement shall be governed and construed in
accordance with the laws of England and the Courts of England shall be
deemed the Courts of competent jurisdiction.
11.9. CLAUSE HEADINGS. The clause headings in this Agreement are solely for
convenience or reference and shall not affect the interpretation or
construction of this Agreement or any of the provisions hereof.
11.10. SEVERABILITY. If any provision of this Agreement shall be held to be
illegal or unenforceable, such holding shall not affect the validity or
enforceability of any of the other provisions of this Agreement.
11.11. BINDING EFFECT, ASSIGNMENT. This Agreement shall be binding upon and
insure to the benefit of each of CollaGenex and Licensee and each of
their respective successors and assigns. Licensee may not assign its
rights and obligations hereunder without the prior written consent of
CollaGenex. CollaGenex may assign its rights and obligations hereunder
to a subsidiary or Affiliate of CollaGenex.
11.12. INDEPENDENT CONTRACTORS. Nothing in this Agreement shall create any
association, partnership or joint venture between the parties hereto, it
being understood and agreed that the parties are independent contractors
and neither party shall have the power or authority to obligate the
other in any way.
11.13. APPROPRIATE WORDS. Except where the context otherwise requires, words
denoting the singular include the plural and vice versa; words denoting
one gender include all genders; words denoting persons include firms and
corporations and vice versa.
11.14. REFERENCE TO STATUTES. Reference to any statute, statutory provision or
regulation includes a reference to the statute or statutory provision or
regulation as from time to time amended, extended or re-enacted.
11.15. TIME OF THE ESSENCE. Time of payment should be of the essence of the
Agreement for any payment to be made by the Licensee, its affiliates or
assigns as the case may be pursuant to Clause 3 of this Agreement or
otherwise.
12. FORCE MAJEURE
12.1. All incidences of force majeure (being circumstances beyond the
reasonable control of either party and which have, or may have, a
material affect on the ability to perform under this Agreement
including, but not limited to, failure of power or other utility or
sanitary supplies; fire; flood; earthquake; explosion; riot; strike or
lock-out of that party's own workforce; civil insurrection or unrest;
terrorist activity; war and regulations of any Governmental,
transnational or local authority) shall for the duration and to the
extent of the effects caused thereby release the parties from the
performance of their contractual obligations hereunder.
12.2. The party who has suffered the force majeure ("the Affected Party")
shall notify the other party without delay of any such incidents
occurring and the parties shall discuss the effects of such incidents on
this Agreement and the measures to be taken.
12.3. Each party shall endeavour and take all reasonable steps to avoid or
restrict any force majeure.
12.4. In the event of an incident or incidents of force majeure, the parties
shall as soon as reasonably possible resume performance of their
obligations hereunder but in the event that the force majeure has
prevailed for a continuous period in excess of six (6) months, the party
which is not the Affected Party may terminate this Agreement by notice
in writing, citing force majeure, to the Affected Party.
IN WITNESS WHEREOF, THE PARTIES HAVE CAUSED THIS AGREEMENT TO BE SIGNED BY
THEIR DULY AUTHORISED REPRESENTATIVES THE DAY AND YEAR FIRST ABOVE WRITTEN
COLLAGENEX PHARMACEUTICALS, INC
by
/s/ BM Gallagher
- ------------------------------------------------
Brian M. Gallagher, President and Chief Executive Officer
Attest
/s/ Lisa Shultz
- ------------------------------------------------
COLLAGENEX INTERNATIONAL LIMITED
by
/s/ Robert A. Ashley
- ------------------------------------------------
Robert A. Ashley, Managing Director
LABORATOIRES PHARMASCIENCE S.A.
by
/s/ Jean-Paul Berthome
- ------------------------------------------------
Jean-Paul BERTHOME, President and
Chief Executive Officer