Exhibit 10.33
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
LICENSE AGREEMENT
This LICENSE AGREEMENT (this "Agreement") effective as of the 9th day of June
1999, is entered into by and between Permatec Technologie AG, a Swiss
corporation having its place of business at Xxxxxxxxxxxxxxxx 00, XX-0000 Xxx,
Xxxxxxxxxxx (hereinafter referred to as "LICENSOR") and SOLVAY Pharmaceuticals
B.V., a Dutch corporation having its place of business at X. X. Xxx Xxxxxxxxxx
00, XX 0000 CP Weesp, The Netherlands (hereinafter referred to as "LICENSEE";
both LICENSOR and LICENSEE hereinafter referred to as "Party" and the "Parties",
respectively).
WITNESSETH:
WHEREAS, LICENSOR is a company active in the field of drug delivery and has in
particular expertise in innovative developments in the area of transdermal and
transmucosal delivery routes; and
WHEREAS, LICENSOR has developed a technology platform known as Combi Gel(TM)
consisting of gel formulations combining Estradiol with a progestative as active
ingredients and owns or has rights to certain patents and owns certain
proprietary know-how related to thereto; and
WHEREAS, LICENSEE is a company which markets pharmaceutical products and is
interested, on the basis of all results, data and related information made
available by LICENSOR to LICENSEE, in having granted the rights to register the
Combi-Gel XXXX (as defined below) in the Territory (as defined below), and upon
approval to manufacture, market, distribute and sell the Product (as defined
below) in the Territory; and
WHEREAS, LICENSOR is prepared to grant to LICENSEE under the terms and
conditions set forth hereafter a license under the Patents and Know-How (both as
defined below) to seek registration of the Combi-Gel XXXX in the Territory, and,
upon receipt of such approval(s), to manufacture, market, distribute and sell
the Product for use and sale in the Territory.
NOW THEREFORE, for and in consideration of the premises, mutual covenants and
agreements contained herein, and intending to be legally bound hereby, the
Parties hereby agree as follows:
1. Definitions
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For purposes of this Agreement, the terms defined in this Section 1. shall
have the following meanings:
1.1 "Affiliate" shall mean, with respect to either Party hereto, any
corporation, partnership or other entity controlled by, controlling or
under common control with, such Party, with "control"
meaning direct or indirect beneficial ownership of more than 50% of the
voting power of, or more than 50% of ownership interest in, such
corporation, partnership or other entity.
1.2 "Combi-Gel XXXX" shall mean the Combi-Gel containing Estradiol and
Norethindrone acetate in all concentrations as the sole active ingredients
for pharmaceutical use with humans developed by LICENSOR prior to the
effective date of this Agreement first written hereinabove, which is based
on and/or makes use of and/or is derived by use of the Patents and/or the
Know-How, and which is described in Appendix A attached hereto.
1.3 "Development Plan" shall mean the plan for the development of the Combi-Gel
XXXX agreed upon by the Parties as attached hereto as Appendix B.
1.4 "Know-How" shall mean all information and data, which are not generally
known including, but not limited to, patent claims and related information
not yet disclosed to the public, formulae, procedures, protocols,
techniques and results of experimentation and testing, which (a) relate to
a Combi-Gel and/or the Combi-Gel XXXX and/or the Product, and (b) are
necessary or useful to seek Registration for, and/or to manufacture,
market, distribute and sell, the Product in the Territory, all to the
extent presently or during the term of this Agreement owned or otherwise
acquired by, and at the free disposition of, LICENSOR.
1.5 "Major Market Countries" shall mean each of Germany, France and the United
Kingdom.
1.6 "Net Sales" shall mean the adjusted gross amount invoiced on all sales of
the Product (including, but not limited to, Hospital Sales, Mail orders and
Retail Sales), in the Territory, by SOLVAY and/or its Affiliates and/or
sub-licensee(s) in "bona fide" arm's length sales to independent third
parties in the trade, as per invoices, less only (i) freight insurance and
handling charges (when invoiced as additional charges), (ii) returns,
withdrawals, recalls and allowances actually paid or granted, including
cash and trade discounts, and (iii) sales taxes, value added taxes, duties
and other governmental charges (including Federal and state rebates in
connection with the sale), all in accordance with generally accepted and
customary trade practices.
1.7 "Patents" shall mean all patents and patent applications filed or having
presently or in the future legal force in any country of the Territory
owned by LICENSOR which claim the Combi-Gel XXXX and/or the Product, or the
process to manufacture Combi-Gel XXXX and/or the Product, including but not
limited to the patents and patent applications listed in Appendix C hereto,
together with all patents that in the future issue therefrom in any country
of the Territory, including utility, model and design patents and
certificates of invention, and all divisionals, continuations,
continuations-in-part, reissues, renewals, extensions, substitutions,
confirmations or additions to any such patents and patent applications.
1.8 "Product" shall mean the Combi-Gel XXXX, for which LICENSEE has been
granted the Registration.
1.9 "Registration" shall mean the granting of any and all approvals and
registrations of Product by any Regulatory Authority, including without
limitation price approval, which are
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required and/or necessary under any applicable law, rule, regulation or
other governmental order to market, distribute and sell the Product in any
country of the Territory.
1.10 "Regulatory Authority" shall mean any governmental authority in any country
of the Territory competent to approve pharmaceutical products for
manufacturing, marketing, distribution and sale in any country of the
Territory and/or to approve the price for pharmaceutical products to be
sold in any country of the Territory.
1.11 "Territory" shall mean all the countries and territories in the world
except for the countries listed in Appendix D, provided that in the event
that LICENSEE duly and timely exercises its option under Section 6. below,
the countries constituting the Extended Territory (as defined in Section
6.1 below) shall thereafter also be covered by the term Territory.
2. Grant of License
----------------
2.1 LICENSOR hereby grants to LICENSEE the exclusive, sub-licensable right and
license (hereinafter referred to a the "License") to pursue the development
in accordance with the Development Plan as required in order to apply for
Registration(s) for the Combi-Gel XXXX, and upon receipt of such
Registration, to manufacture, market, distribute and sell the Product, in
the Territory, and to use the Patents and Know-How exclusively for that
purpose, all in accordance with the provisions contained in this Agreement
and subject to the payment of the Milestone Payments and the Royalty
pursuant to Section 5. below.
2.2 For the avoidance of doubt, LICENSEE explicitly acknowledges and agrees
that the License under the Patents and the Know-How granted hereunder is
strictly limited to the Combi-Gel XXXX (as defined in Section 1.2 above)
and the Product (as defined in Section 1.6 above), and LICENSOR does not
grant any license with respect to any other product under its proprietary
technology platform consisting of gel formulations combining Estradiol with
a progestative (other than Norethindrone Acetate) as active ingredients. It
is, however, expressly understood that LICENSEE shall have a right of first
refusal on any gel formulation developed by LICENSOR on its own combining
Estradiol with any other progestative. LICENSOR shall offer to LICENSEE the
same rights for such other combination as set out in 2.1 hereinabove under
an agreement comparable to this Agreement with the commercial terms and
conditions to be mutually agreed upon by the Parties in good faith
negotiations. LICENSEE may exercise such right of first refusal within
three (3) months following the receipt of the respective offer.
2.3 Notwithstanding any sub-license(s) to be granted by LICENSEE hereunder,
LICENSEE shall continue to be bound by any and all obligations under this
Agreement, as if no sub-license was granted, and LICENSEE shall be
responsible for any and all acts, deeds and omissions of any of its
sub-licensee(s) hereunder, during the term of this Agreement.
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3. Pharmaceutical and Technical Development
----------------------------------------
3.1 Promptly upon execution of this Agreement or receipt of the first Milestone
Payment referred to in Section 5.1(a) below, which ever is the later,
LICENSOR shall initiate and thereafter pursue the development steps for the
Combi-Gel XXXX listed in the Development Plan to fall within the
responsibility of LICENSOR. Upon completion of such development steps,
LICENSOR shall provide LICENSEE with a copy of all information, data and
Know-How freely available to LICENSOR necessary and/or useful to allow
LICENSEE to manufacture or have manufactured the batches of Combi-Gel XXXX
necessary for applying for Registration and for stability testing.
3.2 LICENSEE shall be solely responsible for and undertakes to diligently
pursue to meet the time-frame set forth in the Development Plan, at its own
cost, any and all development steps, actions and other activities
necessary, required or useful to seek and apply for Registration of the
Combi-Gel(TM) XXXX, including without limitation the development steps
listed in the Development Plan falling within the responsibility of
LICENSEE, provided that LICENSOR shall provide such reasonable assistance
and support to LICENSEE with respect to such development steps upon
LICENSEE's request at the cost and expense of LICENSEE.
3.3 Any and all cost incurred by LICENSOR in connection with the performance of
the development steps within its responsibility pursuant to the Development
Program and any assistance and support provided upon request by LICENSOR
under Sections 3.1 and 3.2 above, shall be reimbursed by LICENSEE on the
basis of actual cost, plus any and all out-of-pocket expenses, incurred or
spent by LICENSOR in connection therewith. In the event that LICENSOR, upon
request or with the consent of LICENSEE, charges any third party with all
or part of such activities, LICENSEE shall reimburse LICENSOR the cost
invoiced by such third party plus an amount equal to twenty percent (20%)
of such invoice amount(s) to cover LICENSOR's workload associated with the
instruction and supervision of such third party. LICENSOR shall provide
LICENSEE with respective invoices, which shall be payable by LICENSEE
within thirty (30) days as of receipt.
3.4 The Parties agree to set up, within thirty (30) days after the mutual
execution of this Agreement a steering committee (the "Steering
Committee"), consisting of four (4) qualified members, of which each Party
may nominate two (2) members. The Steering Committee shall be responsible
for the supervision of the due and timely development of the Combi-Gel XXXX
pursuant to the Development Plan as provided for in this Section 3.
3.5 The Steering Committee shall meet on a regular basis and upon request of
any of its members, but at least quarterly, and each Party shall at such
meetings of the Steering Committee provide the other Party with a written
update on, and with all results and data generated and achieved under, the
development steps performed by either Party pursuant to the Development
Plan. Furthermore, each Party shall promptly inform the other Party in such
meetings of the Steering Committee of any occurred or envisaged delays in
the timely performance of its responsibilities under the Development Plan.
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3.6 The Steering Committee may amend, alter or change, by resolution mutually
agreed upon by all of its members, the Development Plan and the time-limits
for the major development steps contained therein. The Steering Committee
shall strive to always reach unanimous decisions. In case unanimous
decisions cannot be reached, the principal officers of LICENSEE and
LICENSOR or their designees should try to dissolve the dispute. If such
principal officers of the Parties, despite good faith and diligent
negotiations, are unable to agree upon a decision, the principal executive
officers of both LICENSEE and LICENSOR shall convene and attempt in good
faith to find a solution acceptable to both Parties. In the event that such
solution may not be found, the principal executive officer of LICENSEE
shall have the final decision. In the event that the timeframe contained in
the Development Plan is delayed by any such decision of the principal
executive officer of LICENSEE by more then twelve (12) months, then
LICENSOR shall have the right to terminate this Agreement, unless such
decision is based on scientific and/or technical reasons only.
4. Registration of the Combi-Gel XXXX
----------------------------------
4.1 Promptly upon completion of all development steps under the Development
Plan required therefor, LICENSEE undertakes to initiate and thereafter
diligently pursue any and all steps and action referred to in Section 3.2
above as they are necessary and/or required to submit to any competent
Regulatory Authority in all Major Market Countries of the Territory, at its
own cost, under its sole responsibility and its own name, request(s) for
Registration of the Combi-Gel XXXX (hereinafter the "Request"); for all
other countries of the Territory, where Registration of the Combi-Gel XXXX
is commercially viable, LICENSEE shall use all commercially reasonable
efforts to prepare and submit such Requests. Upon submission of any such
Request, LICENSEE shall promptly inform LICENSOR thereof, and thereafter,
LICENSEE shall use all commercially reasonable efforts to prosecute each
such Request submitted and keep LICENSOR promptly informed on all
developments related thereto.
4.2 Furthermore, LICENSEE undertakes to inform LICENSOR of all material
developments and correspondence exchanged with any Regulatory Authority in
connection with any Request and/or any Registration, including the
obtention of any Registration by providing a copy of the letter of
allowance.
5. License Fees and Royalties
--------------------------
5.1 As consideration for the License granted by LICENSOR to LICENSEE under this
Agreement, and in consideration of the development of the Combi-Gel XXXX
prior to the effective date of this Agreement first written above by
LICENSOR, LICENSEE undertakes to pay to LICENSOR a license fee in the
aggregate amount of USD 5 million (five million United States Dollars),
which license fee shall be payable by LICENSEE in four (4) payments (each a
"Milestone Payment") within thirty (30) days after the occurrence of the
following events:
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(a) a first Milestone Payment in the amount of USD 1.0 million
(one-million United States Dollars) upon execution of this Agreement;
and
(b) a second Milestone Payment in the amount of USD 1.0 million
(one-million United States Dollars) upon initiation of PhaseIIb/III
clinical trials; and
(c) a third Milestone Payment in the amount of USD 1.0 million
(one-million United States Dollars) upon the filing of the first
Request to any Regulatory Authority; and
(d) a fourth Milestone Payment in the amount of USD 2.0 million
(two-million United States Dollars) upon receipt of the first
Registration for the Product in any one Major Market Country.
5.2 In addition to the Milestone Payments under Section 5.1 above, LICENSEE
shall pay to LICENSOR as further consideration for the License granted
hereunder a royalty (the "Royalty") in an amount equal to five percent (5%)
of Net Sales of Product on a country-by-country basis, during a period (the
"Royalty Term") of (i) fifteen (15) years as from the first commercial sale
of Product in each country of the Territory, or (ii) until the expiration
of the last Patent in such country of the Territory, which ever is the
later. In the event that during the Royalty Term in any country of the
Territory (i) no Patent is in force, and/or (ii) a third party Competing
Product is marketed, then the Royalty rate shall be reduced to *****
percent (**%) of Net Sales of Product in such country only, whereby
"Competing Product" shall mean a product being a similar formulation
containing the same two active ingredients for the identical indications as
Product, which does not infringe any claim under the Patents.
5.3 All Royalty under Section 5.2 above shall be payable quarterly, and
LICENSEE shall remit to LICENSOR within six (6) weeks after the end of each
calendar quarter, for the first time after the fifth Milestone Payment
under Section 5.1(e) became due, the amount of Royalty due with respect of
Net Sales achieved in the preceding calendar quarter. LICENSEE shall
deliver to LICENSOR, along with such remittance of Royalty payment, a
detailed statement on a country-by-country basis (hereinafter referred to
as the "Royalty Report") of the Net Sales of Product achieved and the
applied Royalty rate under Section 5.2, to which the Royalty payment
relates. All Royalty Reports shall be prepared in accordance with generally
accepted accounting principles consistently applied from applicable period
to period and shall be certified by an officer of LICENSEE as being so
prepared, true, accurate and correct.
5.4 Unless otherwise agreed by the Parties in writing, all payments under this
Section 5. shall be made in United States Dollars and to such place or
account as LICENSOR reasonably requests from time to time in writing. To
the extent that Net Sales of Product will be calculated in any currency
other than United States Dollars, LICENSEE shall convert calculation of
such Net Sales from such other currency into United States Dollars at the
average of the selling/buying exchange rate published by the Wall Street
Journal Europe at the last day of the calendar quarter during which such
Net Sales were made.
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***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
6. Extension of Territory
----------------------
6.1 LICENSOR hereby grants LICENSEE the right and option (the "Option") to
extend the Territory as defined in the first sentence of Section 1.11 above
to include also the country of Canada (the "Extended Territory").
6.2 LICENSEE may exercise its option under Section 6.1 by written notice at no
cost at any time during the first three (3) months (the "Option Period")
after the effective date first written above. During such Option Period,
LICENSEE shall evaluate with the Regulatory Authority in Canada whether any
additional and/or specific requirements for the filing of a Request and/or
for the Registration in Canada are to be met.
6.3 In the event that LICENSEE shall duly and timely exercise the Option, then
the Parties shall negotiate in good faith and mutually agree upon the
increase of Milestone Payments under Section 5.1 above as additional
consideration for the inclusion of the Extended Territory. In the event
that LICENSEE shall not duly and timely exercise the Option, then the
Option granted under this Section 6. shall lapse and fall away, and
LICENSOR shall retain any and all rights to and interest in the Combi-Gel
XXXX and the Product in the Extended Territory.
7. Inspection and Audit
--------------------
7.1 During the term of this Agreement and during a period of twelve (12) months
after its expiration or termination for any reason, upon the written
request of LICENSOR and not more than once each calendar year, LICENSEE
shall permit an independent certified public accountant selected by
LICENSOR and acceptable to LICENSEE (not to be withheld or delayed
unreasonably) to have access during regular business hours to such of the
records of LICENSEE and its Affiliates and sub-licensee(s) as may be
reasonably necessary to verify the accuracy of the Royalty Reports for any
year ending not more than thirty-six (36) months prior to the date of such
audit request. The accounting firm shall disclose to LICENSOR only whether
the Royalty Reports and records of LICENSEE and the amount of Royalty
actually paid are correct or not and the specific details concerning any
discrepancies; no other information shall be shared. The Parties agree to
accept such written audit report as final and binding upon them.
7.2 If such accounting firm concludes that additional Royalty were owed during
any such period audited, LICENSEE shall pay within fourteen (14) days the
difference between the Royalty paid and the Royalty due as of the date
LICENSOR delivers to LICENSEE such accounting firm's written report so
concluding. The fees and expenses charged by such accounting firm with
respect to any such audit shall be paid by LICENSOR, provided however, that
if any such audit discloses that Royalty payable by LICENSEE for any
audited period are more than one-hundred ten percent (110%) of the Royalty
actually paid for such period, then LICENSEE shall pay all reasonable fees
and expenses charged by such accounting firm with respect to such audit.
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8. Proprietary Right and Patents
-----------------------------
8.1 The LICENSOR shall retain title to and full ownership in the Patents and
the Know-How including, but not limited to, any and all developments and
inventions related thereto, if any (hereinafter collectively referred to as
"LICENSOR IPR").
8.2 LICENSEE shall not, directly or indirectly through its officers, directors,
employees, agent, affiliates, customers or other controlled or associated
third parties, acquire any proprietary interest in or other right to
LICENSOR IPR, other than provided in this Agreement.
8.3 LICENSOR shall use all commercially reasonable efforts, at its own cost, to
prepare, prosecute and maintain all patent applications and patent
constituting Patents, and shall keep LICENSEE fully and promptly informed
on any developments or changes relating thereto. If the LICENSOR decides
not to further prosecute any patent application constituting Patents,
LICENSOR shall promptly inform LICENSEE of such decision in writing, and
the Parties shall, upon LICENSEE's written request, meet to discuss any
appropriate action.
8.4 If LICENSEE becomes aware of (i) any product or activity of any kind that
involves or may involve an infringement or violation of LICENSOR IPR, or
(ii) any third-party action, claim or dispute (including, but not limited
to, actions for declaratory judgment alleging the invalidity or
non-infringement) based upon or arising out of LICENSOR IPR, then LICENSEE
shall promptly notify LICENSOR in writing of any such infringement,
violation, action, claim or dispute. LICENSOR undertakes to take and
control the commercially feasible and appropriate, as determined at
LICENSOR's sole discretion, course of action to enforce, or otherwise xxxxx
the infringement of, or defend third-party actions regarding LICENSOR IPR.
LICENSOR shall keep LICENSEE regularly informed on any such action. Where
and to the extent necessary to recover damages suffered by LICENSEE by any
such infringement, LICENSEE shall be made, upon its written request and
where possible, an additional party to any such action taken by LICENSOR.
8.5 LICENSEE shall retain title to and ownership of all results and data
generated and achieved by LICENSEE hereunder and the Registration(s) for
the Product in the Territory, subject to Sections 8.6, 10.4(iv) and 10.7
below. LICENSEE shall be responsible for and shall control, at its own
cost, the preparation, prosecution and maintenance of all Registration(s)
and shall keep LICENSOR fully and promptly informed on any developments or
changes relating thereto. During the term of this Agreement, LICENSEE
shall, at its sole cost, take all steps necessary to prosecute and/or
maintain all Registrations.
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8.6 LICENSOR shall be entitled to use any and all data and results, including
without limitation clinical data, generated by LICENSEE under Section 3.2
above to apply or have applied for and obtain Registrations for Product in
any country outside the Territory, provided that if such Registration of
Product is obtained by or on behalf of LICENSOR, than the Parties shall, in
good faith negotiations, mutually agree on an adequate consideration to
LICENSEE for such use of the results and data, which consideration shall
reasonably reflect the commercial benefit of such use to LICENSOR in such
country(ies).
9. Confidentiality
---------------
9.1 LICENSEE shall maintain in confidence all Know-How and other information of
LICENSOR disclosed by LICENSOR hereunder (the "Confidential Information"),
and shall not use, disclose or grant the use of any of the Confidential
Information except on a need-to-know basis to its Affiliates and
sub-licensee(s) and the respective directors, officers, employees, agents,
consultants, clinical investigators or other permitted contractors, to the
extent such disclosure is reasonably necessary in connection with
LICENSEE's activities as expressly authorised by this Agreement. To the
extent that disclosure is authorised by this Agreement, prior to
disclosure, LICENSEE shall obtain agreement in writing of any such person
to hold in confidence and not make e use of the Confidential Information
for any purpose other than authorised by this Agreement. LICENSEE shall
notify LICENSOR promptly upon the discovery of the unauthorised use or
disclosure of any Confidential Information.
9.2 The obligations of confidentiality and non-use in Section 9.1 above shall
not apply to the extent that (a) LICENSEE (i) is required to disclose
information by law, regulation or order of a governmental agency or a court
of competent jurisdiction, or (ii) is required to disclose information to
any Regulatory Authority for purposes of obtaining Registrations, provided
in each case that LICENSEE shall provide LICENSOR with a copy of the
Confidential Information submitted, or (b) LICENSEE can demonstrate that
(i) the disclosed information was public knowledge, other than as a result
of actions of LICENSEE or its Affiliates or sublicensee(s) or their
respective directors, officers and employees in violation hereof, or (ii)
the disclosed information was rightfully known by LICENSEE as shown by its
written records prior to the date of disclosure to it by LICENSOR
hereunder, or (iii) any Confidential Information was independently
developed by LICENSEE without any use of Confidential Information as shown
by its written records.
9.3 The confidentiality obligations under this Section 9. shall be effective
during the entire term of this Agreement and for a period of five (5) years
after the expiration or earlier termination hereof. LICENSOR shall be
entitled to injunctive remedies and relief against LICENSEE and any third
parties for any breach or threatened breach of the confidentiality
obligations under this Section 9. In the event of a breach of the
confidentiality obligations under this Section 9. by LICENSEE or its
Affiliates or sub-licensee(s) and their respective directors, officers,
employees or any other person who
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were given access to the Confidential Information by LICENSEE, LICENSOR
shall be entitled to receive from LICENSEE any and all actual costs and
damages caused by any such breach.
9.4 The confidentiality and non-use obligations contained in this Section 9.
shall apply mutatis mutandis to LICENSOR with respect to any confidential
information and data relating to LICENSEE's business affairs, trade secrets
and commercial plans disclosed to LICENSOR during the term of this
Agreement, if any.
10. Term and Termination
--------------------
10.1 This Agreement shall enter into force as of the effective date first
written herein above and shall, unless earlier terminated in accordance
with the provisions of Section 10.2 below, expire on a country-by-country
basis upon expiration of the Royalty Term in each country of the Territory.
Upon expiration of the Royalty Term in each country of the Territory
pursuant to this Section 10.1 and payment by LICENSEE of all Milestone
Payments and Royalties due hereunder, the License granted hereunder shall
be deemed a perpetual, fully paid-up and royalty-free license for each such
country of the Territory.
10.2 At any time during the term of this Agreement, this Agreement may be
terminated by giving written notice to that effect, as follows:
(a) by either Party, if the other Party is in default or in breach of any
term or provision hereof and such default or breach continues and is
not remedied within thirty (30) days upon the other Party's written
request to remedy such default or breach; or
(b) by either Party, if the other Party goes into liquidation, voluntarily
or otherwise, other than for the sole purpose or reorganization, or
goes into bankruptcy or makes an assignment for the benefit of
creditors, or in the event of a receiver being appointed of the other
Party's property or parts thereof; or
(c) by either Party (the "Notified Party") within ninety (90) days upon
receipt of the written notice of the other Party (the "Notifying
Party") that the effective control of all or a substantial part
(greater than fifty percent 50%) of the pharmaceutical business of
such Notifying Party, whether by sale of stock or assets, passes into
the hands of a pharmaceutical competitor of the Notified Party, and
the Notified Party can reasonably demonstrate to the Notifying Party
that continuation of this Agreement would materially affect and
negatively influence its business; or
(d) by LICENSOR in case of a breach by LICENSEE of any of the
confidentiality provisions of Section 9 above; or
(e) by LICENSOR, if LICENSEE does not file a Request for Registration in
any Major Market Country(ies) of the Territory within six (6) months
after receipt of
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the first Registration by a Regulatory Authority, with respect to
those Major Market Countries only where no Request has been timely
filed, and in each case only if LICENSEE does not file such Request
within one (1) month after LICENSOR's written request to do so,
subject to Section 12.6 below; or
(f) by LICENSOR, if LICENSEE does not file a Request for Registration in
any country(ies) of the Territory not being a Major Market Country
within six (6) months after receipt of the first Registration of a
Regulatory Authority in a Major Market Country (or the reference
country under the mutual recognition procedure of the European Union,
if applicable), with respect to those countries only where no Request
has been timely filed, and in each case only if LICENSEE does not file
such Request within one (1) month after LICENSOR's written request to
do so, subject to Section 12.6 below; or
(g) by LICENSOR, if any Regulatory Authority has finally denied the
Registration (or any material part thereof) for the Product in any
country of the Territory, with respect to such country or countries
only; or
(h) by LICENSOR, if LICENSEE ceases to market and sell Product in any
country of the Territory, and the marketing and sale is not resumed by
LICENSEE within two (2) month as of LICENSOR's respective notice, with
respect to such country or countries only.
10.3 The termination of this Agreement shall be without prejudice to any rights
and obligations of either Party accrued prior to the effective date of such
termination. LICENSEE shall forthwith make all payments due and outstanding
to LICENSOR at the date of termination. Except as explicitly otherwise
stated in this Agreement, LICENSOR shall not be obliged to refund upon
termination of this Agreement to LICENSEE any payments, including without
limitation the Milestone Payments or the extension fee under Section 6.
above, made by LICENSEE to LICENSOR prior to such termination pursuant to
the provisions of this Agreement.
10.4 In the event of termination of this Agreement for whatsoever reason, then
the License shall immediately be terminated and LICENSEE shall (i)
immediately refrain from using directly or indirectly in any way the
Patents, Know-How and Confidential Information, and (ii) return to LICENSOR
all materials, documentation, information, data and other things furnished
by LICENSOR in connection with this Agreement, including without limitation
any and all Confidential Information and LICENSOR IPR, together with all
copies thereof in LICENSEE's possession or under its control, which were
achieved, produced or received hereunder, all free of any charge, and (iii)
deliver to LICENSOR any and all studies, data, results and protocols
achieved, produced or gained by LICENSEE in performing the development
steps set forth in the Development Plan, all free of any charge, and (iv)
transfer any and all Registrations for Product to LICENSOR or any third
party designated by LICENSOR in writing, if any, and to execute any
document and perform any other act necessary or required for that purpose,
all free of any cost to LICENSOR, subject to Sections 10.5 and 10.7 below.
LICENSOR shall have the
11
right, but no obligation, to use, at its sole discretion, any and all such
material, including without limitation Registrations, if any, for its own
purposes and benefit.
10.5 In the event only that this Agreement is terminated by LICENSEE pursuant to
Section 10.2(a) above, then LICENSOR shall be obliged to reimburse to
LICENSEE all cost and expenses directly incurred by LICENSEE to generate,
acquire or receive the studies, data, results, protocols and Registrations
(if any) to be delivered by LICENSEE to LICENSOR pursuant to Sections
10.4(iii) and l0.4(iv) above.
10.6 In the event that any termination hereunder is limited to one or more
countries of the Territory as provided for in Sections 10.2(e), (f), (g)
and (h) above, than the effects of termination shall only apply to such
country or countries of the Territory, but shall not affect in any way the
validity of this Agreement with respect to any other country of the
Territory.
10.7 In the event that the Agreement with respect to any country or countries of
the Territory, for which Registration of Product has been obtained, is
terminated pursuant to Section 10.2(i) above, then LICENSEE shall be
obliged to transfer such Registration(s) in such country(ies) of the
Territory to LICENSOR or any third party(ies) designated by LICENSOR,
against a mutually acceptable consideration payable by LICENSOR (or such
third party) to LICENSEE, which consideration shall be negotiated in good
faith between the Parties.
10.8 Notwithstanding anything contained in Sections 10.4 and 10.5 above, the
termination of this Agreement by either Party shall not limit remedies
which may be otherwise available in law or equity to either Party.
11. Representations and Warranties
------------------------------
11.1 LICENSOR represents and warrants that it has all rights regarding Patents,
Know-How and the Combi-Gel XXXX necessary to grant the License hereunder.
Notwithstanding the preceding sentence, LICENSOR does not assume any
responsibility and makes no representation or warranty that the performance
of this Agreement, the Combi-Gel XXXX and/or the Product, do not infringe
any third party's patents, patent applications or other intellectual
property rights. Furthermore, LICENSOR makes no representation or warranty,
express or implied, with respect to the Combi-Gel XXXX and/or the Product
and/or the Know-how, including without limitation, any warranty of
completeness, accuracy, merchantability or fitness for a particular purpose
thereof, in particular with respect to the intended purpose of successful
Registration in any country of the Territory.
Nothing in this Agreement shall be construed as a representation made, or
warranty given, by LICENSOR that any patent will issue based upon any
pending patent application encompassed by the term Patents, and that any
patent encompassed by the term Patents issued or which issues will be valid
or enforceable.
12
LICENSOR assumes no liability or responsibility hereunder for any damages
caused to LICENSEE, third parties, animals and/or the environment by the
manufacturing, marketing or use of the Combi-Gel XXXX and/or the Product or
the active ingredients contained therein, except to the extent that any
such damage is attributable to the gross negligence or willful misconduct
of LICENSOR in performing its obligations hereunder.
11.2 LICENSEE represents and warrants to use all commercially reasonable efforts
to perform and pursue all steps and actions required for, and apply for and
pursue the Registration for Product in each country of the Territory within
the time-limits set forth in the Development Plan, and, upon such
Registration(s) being granted, to market and sell Product throughout all
Major Market Countries, and to use all commercially reasonable efforts to
that effect in all other countries of the Territory, during the term of and
in accordance with this Agreement.
Furthermore, LICENSEE represents and warrants that it shall at all times
comply with and respect any and all applicable laws, rules, regulations and
orders, including all terms and conditions of the Registration(s) (if any),
when manufacturing, distributing, marketing and selling the Product in any
country of the Territory.
11.3 Subject to the specific representations and warranties given in this
Section 11., and further subject to anything to the contrary contained in
this Agreement, either Party shall, as to third parties, be indemnified and
held harmless by the other Party from and against any and all losses,
liabilities and damages (including attorney's fees) arising from any claim,
action or other proceedings by any third party relating to any acts or
omission of the other Party, its directors, officers, employees or agents,
or any breach of the representations and warranties given by either Party
in this Section 11., or the negligence or willful misconduct of such other
Party, its directors, officers, employees or agents in performing any of
its obligations under this Agreement.
12. Miscellaneous Provision
-----------------------
12.1 Entire Agreement: The terms, covenants, conditions and provisions contained
in this Agreement, including its Appendices referred to herein and together
with the Supply Agreement, constitute the total and complete agreement of
the Parties regarding the subject matter hereof and supersede all prior
understandings and agreements hereto made, and there are no other
representations, understandings or agreements relating to the subject
matter hereof. The provisions of this Agreement may not be waived, altered,
amended or repealed in whole or in part except by the written consent of
both Parties to this Agreement.
12.2 Assignment: This Agreement may not be assigned or otherwise transferred,
nor except as expressly provided hereunder, may any right or obligation
hereunder be assigned or transferred by either Party without the prior
written consent of the other Party to any third party other than an
Affiliate of such Party. Any permitted assignee shall assume all
13
obligations of its assignor under this Agreement or under the respective
rights or obligations actually assigned.
12.3 Notices: Any consent, notice or report required or permitted to be given or
made under this Agreement by one Party to the other shall be in English and
in writing, delivered personally or by international courier service or by
facsimile (promptly confirmed by personal delivery or international courier
service) addressed to the other Party at its address indicated below, or to
such other address as shall have been notified in writing to the sending
Party by the receiving Party from time to time, and shall take effect upon
receipt by the addressee.
If to LICENSOR: Permatec Technologie AG
c/o Permatec Pharma AG
Xxxxxxxxxxx 00
XX-0000 Xxxxxxx, Xxxxxxxxxxx
with copy to: Xxxxxxxxxxxx Xxxxx & Xxxxxxxxxxx
Xxxxxxxxxxxxxxxx 0
XX-X-0000 Xxxxxx, Xxxxxxxxxxx
If to LICENSEE: Solvay Pharmaceuticals B.V.
C. J. Van Xxxxxxxxxx 00
XX-0000XX Xxxxx, Xxx Xxxxxxxxxxx
12.4 Independent Contractors: It is expressly agreed that the Parties shall be
independent contractors and that the relationship between the Parties shall
not constitute a partnership, joint venture or agency. Neither Party shall
have the authority to make any statements, representations or commitments
of any kind, or to take any action, which shall be binding on the other
Party, without the prior written consent of the other Party to do so.
12.5 Severability: Each Party hereby acknowledges that it does not intend to
violate any public policy, statutory or common laws, rules, regulations,
treaty or decision of any government agency or executive body thereof of
any country or community or association of countries. Should one or more
provisions of this Agreement be or become invalid, the Parties hereto shall
substitute, by mutual consent, valid provisions for such invalid provisions
which valid provisions in their economic effect are sufficiently similar to
the invalid provisions that it can be reasonably assumed that the parties
would have entered into this Agreement with such valid provisions.
12.6 Force Majeure: Neither Party hereto shall be held liable or responsible to
the other Party nor be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from causes
beyond the reasonable control of the affected Party, including but not
limited to fire, floods, embargos, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotions, strikes, lockouts
or other labour disturbances,
14
acts of God, omissions or delays in acting by any governmental authority or
the other Party hereto.
12.7 Headings: The titles and headings used in this Agreement are intended for
convenience only and shall not in any way affect the meaning or
construction of any provision of this Agreement.
12.8 Waiver: The waiver by either Party hereto of any right hereunder or the
failure to perform or of a breach by the other Party shall not be deemed a
waiver of any other right hereunder or of any other breach or failure by
said other Party whether of a similar nature or otherwise.
12.9 Counterparts: This Agreement may be executed in two or more counterparts,
each of which shall be deemed an original, but all of which together shall
constitute one and the same instrument.
13. Dispute Resolution and Arbitration
----------------------------------
13.1 In the event of any dispute arising between the Parties concerning this
Agreement, LICENSOR and LICENSEE agree that in the first place they shall
meet for good faith discussions in an attempt to negotiate an amicable
solution.
13.2 The Parties agree that any dispute, controversy or claim arising out of or
relating to this Agreement, or the interpretation, breach or enforcement
thereof, which cannot be amicably resolved pursuant to Section 13.1 above
within two (2) months as from the first appearance of such dispute, shall
be settled by arbitration under the Rules of Arbitration of the
International Chamber of Commerce (the "Rules") by a panel of three (3)
arbitrators selected in accordance with the Rules. Any arbitration
proceeding commenced by either Party shall be held in the Paris, France,
and the language governing any such proceedings shall be English. The
decision of the arbitrators shall be final and binding upon the Parties,
and judgment upon the decision by the arbitrators may be entered in any
court of competent jurisdiction, and execution may be had thereon. The
expense of such arbitration, including attorneys' fees, shall be allocated
between the Parties as the arbitrators may decide and as the claims and
interests of each party may prevail.
13.3 Notwithstanding anything contained in Section 13.2 above, either Party may
seek preliminary or injunctive measures or relief in any competent court
having jurisdiction.
14. Applicable Law
--------------
The Parties hereby agree that this Agreement, all transactions executed
hereunder and all relationship between the Parties in connection therewith,
shall be construed under and be governed by the laws of Switzerland without
reference to the conflict of law principals thereof, and shall not be
governed by the United Nations Convention on Contracts for the
International Sale of Goods (the Vienna Convention of April 11, 1980).
15
IN WITNESS WHEREOF, the Parties have executed this Agreement effective as of the
date first written above.
The LICENSOR: Permatec Technologie AG
/s/ X. Xxxxxxx
------------------------------ ------------------------------------
(Place and Date) by: Xx. X. Xxxxxxx
its: President
The LICENSEE: SOLVAY Pharmaceuticals B. V.
Weesp, 9/6/99 /s/ X. Xxxxxxxx
------------------------------ ------------------------------------
(Place and Date) by: X. Xxxxxxxx
its: President
16
Appendix A
Description of Combi-Gel XXXX
pursuant to Section 1.2
Combi Gel(TM) XXXX is a transparent, non-staining gel to be applied once-a-day
in postmenopausal women.
Based on Permatec's Combi Gel(TM)Technology, it delivers transdermal levels of
two hormones: 17-beta Estradiol and Norethindrone Acetate.
Combi Gel(TM) XXXX is protected by different patents on the Combi Gel(TM)
Technology.
00
Xxxxxxxx X
Development Plan
pursuant to Section 1.3
Tentative Development Plan: (activities to be done by Solvay Pharmaceuticals
-------------------------- unless mentioned differently)
Assumptions
-----------
1. Start of the program by April 1, 1999
2. ********
3. ********
Preclinical
-----------
- ********
- ********
- ********
- ********
Pharmaceutical Development
--------------------------
Manufacturing: responsibility:
---------------
- ******** P
- ******** S
- ******** S
- ******** S
Analytical methods:
- ******** S
- ******** S
- ******** ******** ********* ********* *******
- ******** P
- ******** S/P
- ******** S/P
Stability:
- ******** P
- ******** S
********: P
********: S
18
***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
********: S
********: P
********: S
S = Solvay
P = Permatec
Phase 1*
********:
- ********
- ********
- ********
- ********
Phase II / III*
********:
- ********
- ********
- ********
* Planning of the milestones, assuming a start of the program on April 1, 1999
----------------------------------------------------------------------------
1. End of phase I : 2Q2000
2. End of phase II/III : ******
3. ******** : ******
4. ******** : ******
19
***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
Appendix C
List of Patents
pursuant to Section 1.6
Combi GEL(TM) Technology is covered by a patent having the following title:
"A novel composition for transdermal administration of an estrogen, a progestin
or a mixture thereof".
This patent has been applied in the following countries:
Italy: - Granted on 07/04/98
----- - Patent Number: 1.283.102
South Africa: - Granted on 25/03/98
------------ - Patent Number: 97/4981
New Zealand: - Granted on 19/03/98
----------- - Patent Number: 328021
Europe: - Date of Application: 04/06/97
------ - Application Number: 97108989.1
- Date of Publication: 10/12/97
- Publication Number: EP 0811 381
USA: - Date of Application: 05/06/97
--- - Application Number: 08/869,982
- Notice of Allowability received in November 0000
Xxxxxx: - Date of Application: 05/06/97
------ - Application Number: 2,207,144
Australia: - Date of Application: 05/06/97
--------- - Application Number: 00000/00
Xxxxx: - Date of Application: 05/06/97
----- - Application Number: 9-185695
- Date of Publication: 17/03/98
- Publication Number: 10-7235 1
South Korea: - Date of Application: 04/06/97
----------- - Application Number: 97-23 704
20
Taiwan: - Date of Application: 06/06/97
------ - Application Number: 86107807
Argentina: - Date of Application: 06/06/97
--------- - Application Number: P970102497
21
Appendix D
Countries included in Territory
pursuant to Section 1.10
The term Territory as defined in Section 1.10 shall include all the countries
and territories in the world with the exception of:
1. USA
2. Canada (subject to the Option under Section 6. of the Agreement)
3. Japan
4. Korea
22
