Exhibit 10.33
MARKETING LICENSE AGREEMENT
This Marketing License Agreement (the "Agreement") made and entered
into as of this 4th day of June, 2002 (the "Effective Date") is by and among
Columbia Laboratories (Bermuda) Limited, a Bermuda corporation with its
principal place of business at Rosebank Center, 00 Xxxxxxxxxx Xxxx, Xxxxxxxx,
XX00 Xxxxxxx ("Xxxxxxxx Bermuda"), Columbia Laboratories, Inc., a Delaware
corporation with its principal place of business at 000 Xxxxx Xxxxxx Xxxxxx,
Xxxxxxxxxx, Xxx Xxxxxx 00000 ("Columbia"), Ares Trading S.A., a Swiss company
with its principal place of business at Xxxxxxx xx Xxxxxxxxx, 0000 Xxxxxxxxx,
Xxxxxxxxxxx ("Ares") and Serono, Inc., a Delaware corporation with its principal
place of business at Xxx Xxxxxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxxxxx 00000
("Serono").
WITNESSETH:
WHEREAS, Ares and Columbia Bermuda entered into a License and Supply
Agreement as of May 20, 1999, under which Columbia Bermuda granted to Ares a
license to certain Patents and Technology related to the Product, including the
exclusive right and license, with the right to sublicense, under such Patents
and Technology to market, use and sell the Product in the Territory, and
Columbia Bermuda agreed to manufacture and sell to Ares the Product (as such
terms are defined in the License and Supply Agreement);
WHEREAS, Ares has appointed Serono as the exclusive distributor of the
Product in the United States, subject to the terms of the License and Supply
Agreement; and
WHEREAS, Serono desires to grant to Columbia an exclusive license,
subject to the terms of the License and Supply Agreement including, without
limitation, Section 2(h) thereof, to Promote and sell the Product in the United
States (as hereinafter defined) to the Non-Fertility Specialist Market (as
hereinafter defined), and Columbia desires to receive such exclusive license, on
the terms and subject to the conditions set forth herein.
NOW, THEREFORE, for and in consideration of the mutual premises and
covenants herein contained, the parties hereto agree as follows.
1. Definitions. As used in this Agreement, the following terms
shall have the respective meanings set forth below:
(a) "Affiliate" shall mean any corporation or other
business entity that either directly or indirectly controls a party to
this Agreement, is controlled by such party, or is under common control
of such party. As used herein, the term "control" means possession of
the power to direct or cause the direction of the management and
policies of a corporation or other entity whether through the ownership
of voting securities, by contract or otherwise.
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(b) "AHPC" shall mean Wyeth (formerly American Home
Products Corporation) of Five Giralda Farms, Madison, New Jersey
07940-0874, a Delaware corporation, represented by its Wyeth-Ayerst
Laboratories Division.
(c) "Ares' Net Sales" shall have the meaning attributed to
"Net Sales" under the License and Supply Agreement.
(d) "Assignment Agreement" shall mean the Assignment and
Royalty Agreement dated as of May 27, 1999, as amended, by and between
AHPC and Ares.
(e) "Columbia's Net Sales" shall mean the aggregate
equivalent of gross revenue received by Columbia, its Affiliates and
sublicensees from or on account of the sale of the Product under this
Agreement to non-affiliated third parties, less (i) reasonable credits
or allowances, if any, actually granted on account of cash or trade
discounts, recalls, rebates, rejection or return of the Product
previously sold, (ii) excises, sales taxes, value added taxes,
consumption taxes, duties or other taxes imposed upon and paid with
respect to such sales (excluding income or franchise taxes of any kind)
and (iii) separately itemized insurance and transportation costs
incurred in shipping the Product to such third parties. No deduction
shall be made for any item of cost incurred by Columbia, its Affiliates
or sublicensees in preparing, manufacturing, shipping or selling the
Product except as permitted pursuant to clauses (i), (ii) or (iii) of
the foregoing sentence. Columbia's Net Sales shall not include any
transfer between Columbia and any of its Affiliates or sublicensees for
resale. No transfer of the Product for test or development purposes or
as free samples shall be considered a sale hereunder for accounting or
payment purposes. For the avoidance of doubt and for the purposes of
this definition (i) Ares shall not be deemed to be a sublicensee of
Columbia, and (ii) the sale, license or other transfer to an Affiliate
or sublicensee shall not be considered a sale hereunder for accounting
or payment purposes. Notwithstanding the foregoing, Columbia's Net
Sales of Products that are dispensed to patients within the Fertility
Specialist Market shall be calculated in the manner set forth in
Exhibit B.
(f) "Confidential Information" shall mean all information
and/or technical data which is disclosed by one party hereto pursuant
to this Agreement which the disclosing party treats as confidential and
identifies as such, other than information (i) known to the receiving
party or its Affiliates prior to the disclosure of such information to
such party, provided said prior knowledge is supportable by documentary
evidence, (ii) which at the time of the disclosure is, or thereafter
becomes, generally known to the public, provided that such public
knowledge does not result from any act or disclosure by the receiving
party or any of its Affiliates in violation of the terms of this
Agreement, (iii) which can be shown to be independently discovered,
after the date hereof, by a party, or any of its Affiliates, without
the aid, application or use of the disclosed information, or (iv)
obtained by the receiving party from a third party which is determined
to be in lawful possession of such information, provided such third
party is not in violation of any contractual or legal obligation to the
disclosing party or any of its Affiliates with respect to such
information. Confidential Information of Ares and Serono shall be
deemed to include Dispensing Data disclosed by either one of them to
Columbia or Columbia Bermuda, regardless of whether such Dispensing
Data is identified as
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 2 -
confidential. Confidential Information of Columbia and Columbia Bermuda
shall be deemed to include Dispensing Data disclosed by either one of
them to Ares or Serono regardless of whether such Dispensing Data is
identified as confidential.
(g) "Dispensing Data" shall mean Non-Retail Data and
Prescriber Data.
(h) "FDA" shall mean the U.S. Food and Drug
Administration.
(i) "Fertility Specialist Market" shall mean (i) all
reproductive endocrinologists in the United States and their patients;
and (ii) all other physicians in the United States, including
obstetricians and gynecologists, who use Injectable Gonadotropins to
treat infertility or who are associated with an infertility treatment
center and their patients. Serono and Columbia shall agree in writing
to a list of the reproductive endocrinologists and other physicians who
they have determined are within the Fertility Specialist Market as of
the Effective Date (the "Physician List"). No more than once each year
during the Term of this Agreement beginning on the first anniversary of
the Effective Date, Serono shall consider, at the request of Columbia,
removing from the Physician List physicians in the United States (i)
who are not reproductive endocrinologists, (ii) who are not associated
with an infertility treatment center and (iii) who Columbia
demonstrates prescribed less than $[***] of Injectable Gonadotropins in
the preceding year. Serono shall consider removing such physicians from
the Physician List in good faith giving primary consideration to its
own business interests. Serono shall have the right to remove from the
Physician List any physician upon prior notice to Columbia. Serono
shall have the right to add to the Physician List reproductive
endocrinologists in the United States and other physicians in the
United States, including obstetricians and gynecologists, who use
Injectable Gonadotropins to treat infertility or who are associated
with an infertility treatment center, provided that Serono shall notify
Columbia, Columbia shall have fifteen (15) days thereafter to provide
comments to Serono regarding such additions, and Serono shall consider
such comments in good faith giving primary consideration to its own
business interests.
(j) "Injectable Gonadotropins" shall mean follicle
stimulating hormone, human menopausal gonadotropin, human chorionic
gonadotropin, gonadotropin releasing hormone and luteinizing hormone.
(k) "License and Supply Agreement" shall mean the License
and Supply Agreement dated as of May 20, 1999, by and between Columbia
Bermuda and Ares, as amended and restated by that certain Amended and
Restated License and Supply Agreement dated as of the date hereof and
as further amended in writing and from time to time by agreement of the
parties.
(l) "Non-Fertility Specialist Market" shall mean
individual obstetricians, gynecologists and primary care physicians
located in the United States and their nurses, staff and patients, but
excluding the Fertility Specialist Market.
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 3 -
(m) "Non-Retail Data" shall mean data acquired by Serono
from objective, reliable third parties regarding the sale of Product by
wholesalers to non-retail dispensing organizations, such as [***].
(n) "Patents" shall have the meaning set forth in the
License and Supply Agreement.
(o) "Prescriber Data" shall mean data acquired by Serono
(i) from objective, reliable third parties regarding the dispensing of
the Product from pharmacies to patients and reported by physician name,
such as [***], and (ii) directly from pharmacies regarding the
dispensing of the Product to patients and reported by physician name,
which is not included in the data described in Subsection (o)(i).
(p) "Product" shall mean Product A and Product B.
(q) "Product A" shall mean progesterone/COL-1620 vaginal
gel containing progesterone in a concentration of four percent (4%).
(r) "Product B" shall mean progesterone/COL-1620 vaginal
gel containing progesterone in a concentration of eight percent (8%).
(s) "Promote" and "Promotional" shall mean, with respect
to the Product, any activities undertaken by or on behalf of a party to
encourage sales or use of the Product, including, without limitation,
sales detail calls, product sampling, journal advertising, direct mail
programs, direct-to-consumer advertising, convention exhibits and all
other forms of marketing, advertising or promotion.
(t) "Technology" shall have the meaning set forth in the
License and Supply Agreement.
(u) "Territory" shall have the meaning set forth in the
License and Supply Agreement.
(v) "Unit" shall mean a single applicator.
(w) "United States" shall mean the several United States,
the District of Columbia and Puerto Rico.
2. Grant of License.
----------------
(a) Subject to the License and Supply Agreement,
including, without limitation, Ares' right under Section 2(h) thereof
to Promote the Product to the Non-Fertility Specialist Market in the
United States to the extent that such Promotional activities are
incidental to its Promotional efforts to the Fertility Specialist
Market, Serono hereby grants to Columbia, and Columbia accepts from
Serono, on the terms and conditions stated herein, the exclusive right
and license, with the right to sublicense as set forth in Section 2(b),
under the Patents and Technology to (i) Promote the Product in the
United States to the Non-Fertility Specialist Market as permitted under
applicable law
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 4 -
and (ii) sell the Product in the United States for any indication or
indications permitted under applicable law.
(b) Columbia shall have the right to sublicense its rights
under Section 2(a) to Columbia's Affiliates and, pursuant to Section
2(c), to third parties. Each sublicense granted by Columbia pursuant to
the terms of this Agreement shall be in writing and shall include
provisions restricting the Promotional and sales activities of such
sublicensee to the same extent Columbia is restricted under this
Agreement and granting Serono and Ares third-party beneficiary status
under the sublicense. Columbia shall notify Serono and Ares of any
default of such sublicense and shall be liable to Serono and Ares for
any action or inaction of such sublicensees that would violate this
Agreement as if the action or inaction were that of Columbia directly.
(c) Columbia may employ a contract sales force or other
third party for the purpose of Promoting the Product on behalf of
Columbia in accordance with this Agreement, provided that such sales
force or other third party does not promote any product that competes
with infertility products offered by Serono at the time Columbia
establishes the relationship with such contract sales force or other
third party.
(d) Columbia shall not seek to register or permit any
third party to register the Product outside of the United Sates for
sale, and will not permit any third party to resell the Product sold by
Columbia under this Agreement outside of the United States.
(e) Neither Ares nor Serono shall grant to any Affiliates,
licensees, sublicensees, or any third party any rights and/or licenses
granted to Columbia herein. Ares retains all rights under the Patents
and Technology in the Territory granted to it under the License and
Supply Agreement and not granted by Serono to Columbia hereunder,
including, without limitation, the right under the Patents and
Technology while the License and Supply Agreement is in effect to (i)
Promote the Product to the Fertility Specialist Market, and (ii) sell
the Product.
3. Columbia's Marketing and Distribution Obligations.
-------------------------------------------------
(a) Columbia may Promote the Product in the United States
to the Non-Fertility Specialist Market pursuant to Section 2 hereof,
and sell the Product in the United States. In furtherance and not in
limitation of the foregoing, Columbia shall not, directly or
indirectly, Promote, or engage third parties to Promote the Product to
the Fertility Specialist Market. Notwithstanding the foregoing,
Columbia shall be permitted to Promote the Product to the Fertility
Specialist Market to the extent that such Promotional activities are
incidental to Promotional efforts in the United States to the
Non-Fertility Specialist Market.
(b) Subject to the other terms of this Agreement including
the special termination right of Serono in Section 10(c), Columbia may
sell the Product in the United States by distributing the Product
through all distribution channels including, without limitation,
managed care, chain pharmacies, wholesalers and independent pharmacies
on terms and conditions established by Columbia in its sole discretion.
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 5 -
(c) Columbia shall Promote and sell the Product in
association with the trademark PROCHIEVEtm or other trademark (the
"Columbia Xxxx") and trade dress that are wholly different from the
CRINONE xxxx and the trade dress currently used by Serono and its
Affiliates in association with the Product. An example of the trade
dress currently used by Serono in association with the Product is
displayed in Exhibit A. Serono acknowledges that the applicator and the
dimensions of the packaging for the Product sold by Columbia may be the
same as that for the Product sold by Serono.
(d) Columbia's Promotional materials, presentations and
sales calls to the Non-Fertility Specialist Market for Product B shall
deliver a sustained, consistent message that any patient who has not
become pregnant after three (3) cycles of treatment using clomiphene
citrate together with Product B should seek care of an assisted
reproduction technology specialist for further treatment. In order for
Serono to verify compliance by Columbia with this Section 3(d) and its
other obligations under this Agreement, Columbia shall, upon the
reasonable written request of Serono, but not more than once per
calendar quarter (i) identify to Serono physicians, nurses and staff
within the Non-Fertility Specialist Market; and (ii) provide Serono
with copies of any communications, including communications sent
electronically, as disseminated by Columbia regarding Product B.
(e) Columbia shall not Promote or market the Product by
comparison or reference to the Product as sold by Serono and its
Affiliates and shall not reference the CRINONE xxxx in Promotional
materials, provided, however, that Columbia may respond truthfully to
unsolicited inquiries regarding the Product and the Product as sold by
Serono.
(f) Notwithstanding anything contained in this Agreement
to the contrary, Columbia may refer to, and otherwise use, all
published and unpublished studies regarding the Product in its
Promotional efforts to the Non-Fertility Specialist Market within the
United States, including reference to the CRINONE xxxx to the extent it
is used to identify the studies.
(g) Columbia shall provide quarterly sales and other
marketing information useful to Serono in monitoring Columbia's sales
progress.
(h) Columbia shall be responsible for receiving and
responding to complaints and requests for information from patients and
others regarding the Product sold by Columbia. Within thirty (30) days
following the end of each calendar month during the term of this
Agreement, Columbia shall provide to Serono a written report detailing
complaints regarding the Product received during such month, provided
that Columbia shall notify Serono of any serious adverse events within
two (2) days following notice to Columbia of such serious adverse
events.
4. Columbia's Obligations Regarding License and Supply Agreement.
Columbia shall supply to Ares under the terms of the License and Supply
Agreement all of Ares requirements of the Product in accordance with Section
4(j) of the License and Supply Agreement before supplying its own requirements.
Columbia shall not take any action that could
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 6 -
reasonably be expected to adversely affect Ares' rights under the License and
Supply Agreement or Columbia's ability to perform fully its obligations
thereunder.
5. Compensation.
------------
(a) Royalties.
(i) Amount. Columbia shall pay to Serono a royalty
of thirty percent (30%) of Columbia's Net Sales of Products
provided that Columbia shall pay an additional amount equal to
forty percent (40%) (but not to exceed seventy percent (70%)
in total) of Columbia's Net Sales of Products that are
dispensed to patients within the Fertility Specialist Market.
(ii) Reports and Payments. Within forty-five (45)
days following each calendar quarter during the Term, Columbia
shall (a) provide to Serono a written report, in such detail
as Serono may reasonably require, showing (i) the description
and number of all Units of the Product sold by Columbia and
its sublicensees during such calendar quarter, the number of
free samples of the Product distributed by Columbia and its
sublicensees, and the number of any returns of the Product
made during such calendar quarter, and (ii) Columbia's Net
Sales of the Product sold during such calendar quarter; and
(b) pay to Serono 30% of such Net Sales in immediately
available funds by wire transfer to an account designated by
Serono. If no amount is due for such calendar quarter, a
written statement to that effect shall be furnished.
(iii) Determination of Market. With respect to each
quarter during the term, Serono shall determine based on the
Dispensing Data and report to Columbia in writing in the form
set forth in Exhibit B (a) the number of Units of Products
sold by Columbia and dispensed to patients within the
Non-Fertility Specialist Market and the Fertility Specialist
Market, (b) Columbia's Net Sales of Product dispensed to
patients within the Non-Fertility Specialist Market and the
Fertility Specialist Market, and (c) the number of Units of
Products sold by Serono and dispensed to patients within the
Non-Fertility Specialist Market in the United States and the
Fertility Specialist Market. Within forty-five (45) days
following receipt of such report, Columbia shall pay to Serono
in immediately available funds by wire transfer to an account
designated by Serono an additional royalty of 40% of
Columbia's Net Sales of all Products sold by Columbia and
dispensed to patients within the Fertility Specialist Market.
In the event that, within fifteen (15) business days following
receipt of such report, Columbia notifies Serono in writing
that Columbia disagrees with such determination and report,
and Columbia provides written documentation supporting such
disagreement, then Serono and Columbia shall refer the matter
to an independent expert in pharmaceutical product marketing
jointly selected by each of the parties (the "Expert") and, if
the parties cannot agree on an Expert, they shall thereafter
request the American Arbitration Association ("AAA"), sitting
in the City of New York, to select an Expert within thirty
(30) days following receipt of such request. In each case, the
Expert shall be selected having regard to his or her
suitability to
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 7 -
determine the particular dispute or difference. Unless
otherwise agreed between Serono and Columbia, the following
rules shall apply to the appointment of the Expert. Serono and
Columbia shall share the fees of the AAA and the Expert
equally. The Expert shall be entitled to inspect and examine
all documentation and any other material that the Expert may
consider to be relevant to the dispute. The Expert shall
afford each party a reasonable opportunity (in writing or
orally) for stating reasons in support of such contentions as
each party may wish to make relative to the matters under
consideration. The Expert shall give notice in writing of his
or her determination to the parties within such time as may be
stipulated in his terms of appointment or in the absence of
such stipulation, as soon as practicable, but in any event
within forty-five (45) days from the reference of the dispute
or difference.
(iv) Post-Termination Report and Payment. Columbia
shall provide to Serono a written report within forty-five
(45) days following the date of any termination of this
Agreement, in such detail as Serono may reasonably require,
showing the items set forth in Section 5(a)(ii) above for
sales of the Product that were not previously reported to
Serono, and shall pay to Serono all amounts that such report
shows are due and that are subsequently determined to be due
under Section 5(a)(iii) in immediately available funds by wire
transfer to an account designated by Serono.
(b) Contribution to Royalties on Sales of Product B over
$[***]. In the event that, for any calendar year or other period, Ares
is required to pay to AHPC royalties under the Assignment and Royalty
Agreement on sales of Product B in excess of $[***], then (i) Ares
shall provide to Columbia a copy of the written report with regard to
such calendar year or other period furnished by Ares to AHPC under the
Assignment and Royalty Agreement, which report shall include the
description and number of all Units of Product B sold by Ares and its
Affiliates (including Serono) and its sublicensees (including Columbia)
during such calendar year or other period and the royalties payable
thereon by Ares to AHPC; and (ii) Columbia shall, within thirty (30)
days following receipt of such report, pay to Ares an amount calculated
by multiplying the royalties payable by Ares to AHPC for such calendar
year or other period by the fraction X/Y where X is Columbia's Net
Sales of Product B in the United States during such calendar year or
other period and Y is Columbia's Net Sales of Product B in the United
States plus Ares' Net Sales of Product B throughout the world during
such calendar year or other period. Such payment shall be made in
immediately available funds by wire transfer to an account designated
by Ares.
(c) Currency. All amounts under this Agreement are in
United States Dollars.
(d) No Implication of Right to Sell to Fertility
Specialist Market. Although Columbia is obligated under the terms of
this Section 5 to pay a higher royalty rate for Columbia's Net Sales of
Product dispensed to patients within the Fertility Specialist Market,
nothing in this Section 5 shall be deemed to grant to Columbia,
directly or indirectly, a license to Promote or engage third parties to
Promote the Product to the
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 8 -
Fertility Specialist Market or be deemed to limit Serono's right to
terminate this Agreement pursuant to Section 10(c).
6. Confidentiality.
---------------
Each party hereto shall hold all Confidential Information in
confidence, use it only in connection with the performance of its obligations
pursuant to this Agreement and use its diligence efforts (consistent with those
which it uses to safeguard its own confidential information) to safeguard
Confidential Information and to prevent the unauthorized use or disclosure of
any Confidential Information. Each party hereto shall ensure that its Affiliates
or employees who have access to any Confidential Information shall be made aware
of and subject to these obligations. The receiving party may disclose
Confidential Information to individuals who have a need to know in order for the
receiving party to perform its obligations or enjoy its rights under this
Agreement, provided that each such individual is bound by a confidentiality
obligation comparable to the obligation set forth in this Section 6. The
obligations of the parties hereto under this Section 6 shall survive for five
(5) years after the expiration or termination of this Agreement.
7. Representations, Warranties and Covenants and Indemnification.
-------------------------------------------------------------
(a) Ares and Serono each hereby represents, warrants and
covenants the following:
(i) It is a corporation duly organized, existing
and in good standing under the laws of the place of its organization, with full
right, power and authority to enter into and perform this Agreement.
(ii) The execution, delivery and performance of this
Agreement do not conflict with, violate or breach any agreement to which it is a
party, or its articles of incorporation or bylaws.
(iii) This Agreement has been duly executed and
delivered by it and is a legal, valid and binding obligation enforceable against
it in accordance with its terms.
(iv) It shall comply with all applicable laws,
consent decrees and regulations of any federal, state or other governmental
authority in performing this Agreement.
(b) Columbia and Columbia Bermuda each hereby represents,
warrants and covenants the following:
(i) It is a corporation duly organized, existing
and in good standing under the laws of the place of its organization, with full
right, power and authority to enter into and perform this Agreement.
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 9 -
(ii) The execution, delivery and performance of this
Agreement do not conflict with, violate or breach any agreement to which it is a
party, or its articles of organization or bylaws.
(iii) This Agreement has been duly executed and
delivered by it and is a legal, valid and binding obligation enforceable against
it in accordance with its terms.
(iv) It shall comply with all applicable laws,
consent decrees and regulations of any federal, state or other governmental
authority in performing this Agreement.
(c) Indemnification.
(i) Serono agrees to indemnify and hold harmless
Columbia, its Affiliates and sublicensees and their respective employees,
agents, officers and directors from and against any claims, losses, liabilities,
damages, costs and expenses (including reasonable attorneys' fees) incurred by
Columbia, its Affiliates or sublicensees arising out of or in connection with
any (A) breach by Ares or Serono of any representation, warranty, covenant or
obligation hereunder, or (B) intentional or negligent act or omission on the
part of Ares or Serono or any of its employees or agents in the performance of
this Agreement.
(ii) Columbia agrees to indemnify and hold harmless
Serono and its Affiliates and their respective employees, agents, officers and
directors from and against any claims, losses, liabilities, damages, costs and
expenses (including reasonable attorneys' fees) incurred by Serono or its
Affiliates arising out of or in connection with any (A) breach by Columbia or
Columbia Bermuda of any representation, warranty, covenant or obligation
hereunder, (B) claim or demand of any kind for injury to person or property
arising from Columbia's or its sublicensees' marketing, Promotion, distribution
or sale of the Product, (C) negligent or intentional act or omission on the part
of Columbia, its sublicensees, Columbia Bermuda or any of their employees or
agents in the performance of this Agreement, or (D) payments, commissions or
fees of any kind due to consultants or brokers retained by Columbia relating to
the Product.
(iii) A party seeking indemnification under this
Section 7 (the "Indemnified Party") must give prompt written notice thereof to
the other party (the "Indemnifying Party"). The Indemnifying Party shall have
the right to defend any such claim or demand subject to the right of the
Indemnified Party to participate with counsel of its choice in such defense,
but the fees and expenses of such additional counsel shall be at the expense
of the Indemnified Party. The Indemnified Party shall cooperate fully in all
respects with the Indemnifying Party in any such compromise, settlement or
defense, including, without limitation, by making available all pertinent
information and personnel under its control to the Indemnifying Party. The
Indemnifying Party will not compromise or settle any claim or demand (other
than, after consultation with the Indemnified Party, a claim or demand to be
settled by the payment of money damages and/or the granting of releases)
without the prior written consent of the Indemnified Party, which consent
shall not be unreasonably withheld.
8. Insurance. Columbia shall maintain and keep in force for the
term of this Agreement comprehensive general liability insurance including
Products/Completed Operations,
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 10 -
Contractual and Broad Form Property Damage covering its indemnification
obligations hereunder with a minimum limit of [***]United States Dollars (U.S.
$[***]) per annum combined single limit for Bodily Injury and Property Damage.
Such insurance shall be placed with a first class insurance carrier with at
least a BBB rating by Standard & Poor's, and shall name Ares as an additional
insured. Upon the execution and delivery of this Agreement, Columbia shall
furnish a certificate of insurance to Serono evidencing the foregoing
endorsements, coverage and limits, and providing that such insurance shall not
expire or be canceled or modified without at least thirty (30) days prior notice
to Serono.
9. Term of License. The term of this Agreement (the "Term")
shall commence on the Effective Date and continue until terminated in accordance
with the provisions of Section 10.
10. Termination.
-----------
(a) This Agreement shall automatically terminate upon the
expiration or termination of the License and Supply Agreement.
(b) This Agreement may be terminated upon the mutual
written agreement of the parties.
(c) Serono may terminate this Agreement upon written
notice to Columbia in the event that (i) the number of Units of
Columbia's Product dispensed to patients within the Fertility
Specialist Market in any calendar quarter, as determined under Section
5(a)(iii), equals or exceeds [***]percent ([***]%) of the number of
Units of Serono's Product dispensed to patients within the Fertility
Specialist Market in such calendar quarter, as determined under Section
5(a)(iii), (ii) Serono notifies Columbia in writing of Serono's intent
to terminate this Agreement under this Section 10(c), and (iii) the
number of Units of Columbia's Product dispensed to patients within the
Fertility Specialist Market equals or exceeds [***]percent ([***]%) of
the number of Units of Serono's Product dispensed to patients within
the Fertility Specialist Market during the three full calendar month
period immediately following receipt of such notice (the "Cure
Period"); provided, however, that Serono may immediately terminate this
Agreement at any time after the Cure Period upon written notice to
Columbia in the event that the number of Units of Columbia's Product
dispensed to patients within the Fertility Specialist Market in any
three-month period after the Cure Period (and not including any month
during the Cure Period) equals or exceeds [***]percent ([***]%) of the
number of Units of Serono's Product dispensed to patients within the
Fertility Specialist Market in such three-month period.
(d) Serono or Columbia may terminate this Agreement
forthwith by written notice to the other, if the other party commits a
material breach of any part of this Agreement and such breach has not
been remedied by the breaching party within sixty (60) days after
written notice of such breach has been given by the other party.
(e) Serono may terminate this Agreement at any time that
Ares is entitled to terminate the License and Supply Agreement pursuant
to Section 14(b) of the License and Supply Agreement due to a material
breach by Columbia Bermuda which is not
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 11 -
remedied within the sixty (60) day cure period of the License and
Supply Agreement or such longer period made part of any applicable cure
plan.
(f) This Agreement may also be terminated by written
notice of Serono, if Columbia becomes involved in financial
difficulties as evidenced:
(i) by its commencement of a voluntary case under
any applicable bankruptcy code or statute, or by its authorizing, by appropriate
proceedings, the commencement of such voluntary case; or
(ii) by its failing to receive dismissal of any
involuntary case under any applicable bankruptcy code or statute within sixty
(60) days after initiation of such action or petition; or
(iii) by its seeking relief as a debtor under any
applicable law of any jurisdiction relating to the liquidation or reorganization
of debtors or to the modification or alteration of the rights of creditors, or
by consenting to or acquiescing in such relief, or
(iv) by the entry of an order by a court of
competent jurisdiction finding it to be bankrupt or insolvent, or ordering or
approving its liquidation, reorganization or any modification or alteration of
the rights of its creditors or assuming custody of, or appointing a receiver or
other custodian for, all or a substantial part of its property or assets; or
(v) by its making an assignment for the benefit of,
or entering into a composition with its creditors, or appointing or consenting
to the appointment of a receiver or other custodian for all or a substantial
part of its property.
(g) The failure by a party to exercise its rights to
terminate this Agreement pursuant to this Section 10 in the event of
any occurrence giving rise thereto shall not constitute a waiver of
such rights in the event of any subsequent occurrence.
(h) Termination of this Agreement shall not release any
party from its obligations accrued prior to the effective date of
termination nor deprive any party from any rights that this Agreement
provides shall survive termination. The obligations of the parties
under Sections 5(a)(iv), 5(b), 6, 7(c), 10(h) and 12 through 26 shall
remain in full force and effect and shall survive the termination of
this Agreement.
11. Publicity.
---------
The parties hereto shall coordinate the preparation and issuance of any
public announcement of this Agreement. Any such announcement shall comply with
relevant Securities and Exchange Commission requirements and shall take into
account any reasonable concern regarding the trade. Columbia and Serono shall
approve in writing the wording of such announcement before release, such
approval not to be unreasonably withheld.
12. Audits.
------
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 12 -
Columbia shall keep accurate records of all Product sales and other
relevant data concerning the Product for a period of two (2) years following the
year in which such records were created. Once a year, upon reasonable notice, at
times mutually agreed upon and during business hours, each of Serono and AHPC,
at Serono's or AHPC's cost, as applicable, may have the accounts of Columbia and
its sublicensees for the preceding two (2) calendar years relating to the
Product reviewed by independent certified public accountants appointed by Serono
or AHPC, as applicable, and reasonably approved by Columbia, solely in order to
verify amounts due under this Agreement. Serono or AHPC, as applicable, and
Columbia shall mutually determine a general strategy for such audit in advance
of its conduct. Said accountant shall not disclose to Serono or AHPC any
information except that which should properly be contained in a quarterly report
required under this Agreement. Columbia shall promptly pay any underpayment
evidenced by such audit, and Serono shall promptly refund any overpayment
evidenced by such audit. In the event such an audit evidences an underpayment of
more than five percent (5%) with respect to the amounts actually paid, Columbia
shall promptly pay such underpayment to Serono with interest at the prime rate
as set by Citibank, from the time when such underpayment accrued, and shall
reimburse Serono for the reasonable costs and expenses (including fees) of such
audit.
13. Notices.
-------
All notices required hereunder shall be in writing and shall be deemed
to be properly given if sent by air courier to the party to be notified at the
address set forth on page 1 hereof, or at such other latest address as a party
may hereafter designate in writing to the other; provided that a copy of each
notice to be sent to Columbia or Columbia Bermuda hereunder shall also be sent
by the same means to General Counsel, Columbia Laboratories, Inc. 000 Xxxxx
Xxxxxx Xxxxxx, Xxxxxxxxxx, XX 00000, XXX, and further provided that a copy of
each notice sent to Ares or Serono hereunder shall also be sent by the same
means to General Counsel, Serono International S.A., 00 xxx xxxxxx xxx Xxxxx,
0000, Xxxxxx, Xxxxxxxxxxx. The date of service of any notice so sent by air
courier shall be the date of receipt.
14. Ownership Change; Assignment; Successors.
----------------------------------------
This Agreement shall be binding on and inure to the benefit of the
successors and permitted assigns of the parties. No party may transfer or assign
this Agreement, in whole or in part, without the consent in writing of the other
parties, and any purported assignment without such consent (which may be
withheld without reason) shall be void; provided, that a party may upon notice
to the other parties assign all or any portion of this Agreement to any of its
Affiliates or to an assignee of the License and Supply Agreement in connection
with a permitted assignment under the License and Supply Agreement. No party
may, following such an assignment to an Affiliate, sell such Affiliate without
the other party's prior written consent unless this Agreement is first assigned
back from such Affiliate to the assigning party. Nothing in this Agreement,
express or implied, is intended to confer on any person other than the parties
hereto, or their respective permitted successors and assigns, any benefits,
rights or remedies.
15. Tax.
---
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 13 -
All taxes levied on account of any payments accruing under this
Agreement which constitute income to Serono, shall be the obligation of Serono,
and if provision is made in law or regulation for withholding, such tax shall be
deducted from any payment then due, paid to the proper taxing authority, and
receipt for payment of the tax secured and promptly sent to Serono.
16. Independent Contractors.
-----------------------
The relationship of the parties under this Agreement is that of
independent contractors. Neither party shall be deemed to be the agent, partner
or joint venturer of the other and neither is authorized to take any action
binding upon the other.
17. Entire Agreement; Modification.
------------------------------
This Agreement, including the Exhibits hereto, contains the entire
understanding between the parties hereto relating to the subject matter hereof,
there being no terms and conditions other than those set forth herein, and it
supersedes all prior agreements, statements or representations, written or oral,
between the parties hereto with respect to the matters covered hereunder. This
Agreement may not be modified, altered or otherwise changed or any of its
provisions waived other than by an instrument in writing, duly executed by each
of the parties hereto. In the event of a conflict between the terms of this
Agreement and the terms of the License and Supply Agreement, the terms of the
License and Supply Agreement shall control.
18. Severability.
------------
If any provision of this Agreement should be or becomes fully or partly
invalid or unenforceable for any reason whatsoever or should be adjudged to
violate any applicable law, this Agreement is to be considered divisible as to
such provision and such provision is deemed to be deleted from this Agreement,
and the remainder of this Agreement shall be valid and binding as if such
provision were not included herein; provided, however, that this Agreement is
not rendered fundamentally different in its content or effect.
19. Effect of Headings.
------------------
The headings for the sections and paragraphs of this Agreement are to
facilitate reference only, do not form a party of this Agreement, and shall not
in any way affect the interpretation hereof.
20. Choice of Law.
-------------
This Agreement and performance hereof shall be construed and governed
by the laws of the State of New York without regard to its rules on conflict of
laws. Any dispute, controversy, claim or difference arising between the parties
out of, relating to, or in connection with this Agreement shall be submitted to
the jurisdiction of the courts sitting in the State of New York.
21. No Waiver.
---------
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 14 -
No delay or omission or failure to exercise any right or remedy
provided for herein shall be deemed to be a waiver thereof or acquiescence to
the event giving rise to such right or remedy.
22. Counterparts.
------------
This Agreement may be executed in any number of counterparts and by the
parties hereto on separate counterparts, each of which, when so executed shall
be deemed an original, but all such counterparts shall constitute but one and
the same instrument.
23. Further Assurances.
------------------
The parties each agree to produce or execute such other documents or
agreements as may be necessary or desirable for the execution and implementation
of this Agreement and the consummation of the transactions contemplated hereby.
24. Exhibits.
--------
The terms and provisions of the Exhibits attached to this Agreement are
hereby incorporated herein as if fully set forth herein.
25. Bankruptcy.
----------
All Patent and Technology rights and licenses granted to the Product
under or pursuant to this Agreement by Serono to Columbia are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, as amended from time to time (the "Bankruptcy Code"), licenses
of rights to "intellectual property" as defined under Section 101 (35A) of the
Bankruptcy Code. The parties hereto agree that so long as Columbia, as a
licensee of such rights under this Agreement, makes all payments to Serono
required under this Agreement, Columbia shall retain and may fully exercise all
of its rights and elections under the Bankruptcy Code. The parties further agree
that, in the event that any proceeding shall be instituted by or against Ares or
Serono seeking to adjudicate it as bankrupt or insolvent, or seeking
liquidation, winding up, reorganization, arrangement, adjustment, protection,
relief or composition of it or its debts under any law relating to bankruptcy,
insolvency or reorganization or relief of debtors, or seeking an entry of an
order for relief or the appointment of a receiver, trustee or other similar
official for it or any substantial part of its property or it shall take an
action to authorize any of the foregoing actions, Columbia, as a licensee of
such rights under this Agreement, shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code.
26. Performance by Affiliates.
-------------------------
The parties acknowledge that certain of their rights and obligations
under this Agreement may be carried out by one or more of their Affiliates;
provided, however, that each party shall remain responsible for the acts and
omission of its Affiliates. The parties further understand and agree that no
such Affiliate is a party to this Agreement, and, except as contemplated by this
Agreement, is not the agent of such party for purposes hereof, is not authorized
to bind such
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 15 -
party and cannot enter into amendments to this Agreement, which can only be made
in accordance with the terms of Section 17 hereof.
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 16 -
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed under seal as of the date first written above by their duly authorized
representatives.
COLUMBIA LABORATORIES (BERMUDA) LIMITED
By: /S/ Xxxxxxx X. Xxxxxxx
----------------------
Name: Xxxxxxx X. Xxxxxxx
Title: Director
COLUMBIA LABORATORIES, INC.
By: /S/ Xxxx Xxxxxxxxx
------------------
Name: Xxxx Xxxxxxxxx
Title: President & CEO
ARES TRADING S.A.
By: /S/ Xxxx - Xxxxxx Verhassel
---------------------------
Name: Xxxx - Xxxxxx Verhassel
Title: Authorized Representative
By: /S/ Jacques Theurillat
----------------------
Name: Jacques Theurillat
Title: Authorized Representative
SERONO, INC.
By: /S/ Xxxx - Xxxxxx Verhassel
---------------------------
Name: Xxxx - Xxxxxx Verhassel
Title: Authorized Representative
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 17 -
DRAFT 5/14/02
EXHIBIT A
Ares' Trade Dress
[LOGO] Crinone
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
EXHIBIT B
Form of Report
Quarterly Period: _________
I. DISPENSING DATA SOURCES:
Prescriber Data:
[[***]]
[[***]]
Non-Retail Data:
[[***]]
II. DISPENSING DATA:
---------------------------------------------------------------------------------------------------------------------
Data Label Data Description and Determination Methodology Data Value
---------------------------------------------------------------------------------------------------------------------
A No. of Units of Columbia's Product dispensed to patients within the Fertility
Specialist Market as shown by Prescriber Data
---------------------------------------------------------------------------------------------------------------------
B No. of Units of Columbia's Product dispensed to patients within the
Non-Fertility Specialist Market as shown by Prescriber Data
---------------------------------------------------------------------------------------------------------------------
C No. of Units of Columbia's Product sold by wholesalers to non-retail
prescribing organizations as shown by Non-Retail Data
---------------------------------------------------------------------------------------------------------------------
No. of Units of Columbia's Product dispensed to patients within the Fertility
Specialist Market
D determined by using the following formula:
A + ((A/(A+B)) x C)/1/
---------------------------------------------------------------------------------------------------------------------
[***]% of Columbia's wholesale acquisition cost (WAC) for Columbia's Product
E on a per-package basis in effect at the end of the applicable quarter / No. of
Units per package*
---------------------------------------------------------------------------------------------------------------------
Columbia's Net Sales of Product dispensed to patients within the Fertility
Specialist Market
F determined by using the following formula:
D x E
---------------------------------------------------------------------------------------------------------------------
G No. of Units of Serono's Product dispensed to patients within the Fertility
Specialist Market as shown by Prescriber Data
---------------------------------------------------------------------------------------------------------------------
H No. of Units of Serono's Product dispensed to patients within the
Non-Fertility Specialist Market as shown by Prescriber Data
---------------------------------------------------------------------------------------------------------------------
I No. of Units of Serono's Product sold by wholesalers to non-retail prescribing
organizations as shown by Non-Retail Data
---------------------------------------------------------------------------------------------------------------------
J No. of Units of Serono's Product dispensed to patients within the
---------------------------------------------------------------------------------------------------------------------
-----------------------
/1/ In any quarter in which Serono has not offered Product A for sale at all
times during such quarter and Columbia has offered Product A for sale at all
times during such quarter, the no. of Units of Columbia's Product dispensed
to patients within the Fertility Specialist Market during such quarter shall
be reduced by the lesser of (i) [***]Units or (ii) the no. of Units of
Product A dispensed by Columbia to patients within the Fertility Specialist
Market during such quarter. This reduction shall be solely for the purposes
of determining Serono's termination right under Section 10(c).
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 19 -
---------------------------------------------------------------------------------------------------------------------
Fertility Specialist Market
determined by using the following formula:
G + ((G/(G+H)) x I)
---------------------------------------------------------------------------------------------------------------------
No. of Units of Serono's Product dispensed to patients within the
K Non-Fertility Specialist Market determined by using the following formula: H
+ ((H/G+H) x I)
---------------------------------------------------------------------------------------------------------------------
[***]% of Serono's wholesale acquisition cost (WAC) for Serono's Product on a
L per-package basis in effect at the end of the applicable quarter / No. of
Units per package*
---------------------------------------------------------------------------------------------------------------------
M Ares' Net Sales of Product through Serono dispensed to
patients within the Non-Fertility Specialist Market
determined by using the following formula:
K x L
---------------------------------------------------------------------------------------------------------------------
III. PAYMENT AMOUNTS:
Columbia to Serono (pursuant to Section 5 of the Marketing License Agreement):
Payment Amount = F x 40%
Serono to Columbia (pursuant to Section 5 of the Amended and Restated License
and Supply Agreement):
Payment Amount = M x 40%
IV. NOTES:
*If Product A and Product B have different per-Unit WACs, then this report will
include additional calculations reflecting such difference.
[***] A CONFIDENTIAL PORTION OF THE MATERIAL HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
- 20 -
