Exhibit 10.31
SEMI-EXCLUSIVE SUPPLY AGREEMENT
This Agreement is made as of this 7th day of May, 2002, by and between Mipharm
S.p.A, a corporation organized and existing under the laws of Italy (the
"Manufacturer"), having its principal place of business at Via B. Quaranta 12
20141, Milan, Italy, and Columbia Laboratories (Bermuda) Limited, a corporation
organized and existing under the laws of Bermuda (the "Owner"), having its
principal place of business at Rosebank Center, 14 Bermudiana Road, Pembroke HM
08, Bermuda. Owner and Manufacturer are herein referred to individually as a
"Party" and collectively as the "Parties".
WITNESSETH:
WHEREAS, the Owner wishes to assure itself and certain of its future licensees
of a continued supply of the Product, as hereinafter defined, and Manufacturer
is willing to provide the Product in accordance with the terms and conditions
hereinafter set forth.
NOW, THEREFORE, in consideration of the premises and the mutual promises herein
contained, the Parties hereto hereby agree as follows:
1. DEFINITIONS
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The following terms shall have the meanings assigned to them:
(a) "Affiliate" shall mean any corporation or other entity that either
directly or indirectly controls a party to this Agreement, is
controlled by such party, or is under common control with 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.
(b) "cGMP" shall mean the current good manufacturing practice for Medicinal
Products and other relevant governmental authority regulations and
standards in the United States and Europe;
(c) "Confidential Information" shall mean all information and/or technical
data which is disclosed by one party hereto to the other party hereto
pursuant to this Agreement which the disclosing party treats as
confidential and identifies as such, other than (i) information 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) information 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 one of its Affiliates in
violation of the terms of this Agreement, (iii) information which can
be shown to be independently discovered, after the date hereof, by a
party, or one of its Affiliates, without the aid, application or use of
the disclosed information, or (iv) information 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 one of its Affiliates with respect to such information.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(d) "Effective Date" shall mean the date first written above.
(e) "FDA" shall mean the U.S. Food and Drug Administration.
(f) "Intellectual Property Rights" shall mean trade secrets, trademarks,
tradenames, logos, trade dress, graphics, designs, patents, copyrights
or other proprietary rights.
(g) "Manufacturer's Know How and Patents" shall mean Manufacturer's
patented and unpatented proprietary manufacturing processes used in the
manufacture of the Product.
(h) "NDA" shall mean a New Drug Application as defined by the FDA.
(i) "Owner's Patents" shall mean the patents and/or patent applications
filed in the Territory owned by the Owner or its Affiliates or with
respect to which Owner or its Affiliates may now or hereafter have the
right to grant licenses in the Territory, the claims of which may be
infringed, absent a license, by the manufacture, use or sale of the
Product within the Territory, including, without limitation, the
patents and applications set forth in Schedule A hereto and any and all
patents issued pursuant thereto, as well as any patents to be applied
for or issued to Owner or its Affiliates in the future during the term
of this Agreement, which future patents and patent applications shall
be added to Schedule A by written notice of Owner to Manufacturer
within thirty (30) days of such application and/or issuance.
(j) "Product" shall mean a testosterone bioadhesive buccal tablet
containing 30 mg testosterone for men for human use supplied in
finished, packaged form pursuant to the Specifications. Product shall
mean both sale as well as sample units and shall include the life cycle
management in all formulations, strengths, dosages.
(k) "Purchase Price" shall have the meaning set forth in Article 7 of this
Agreement.
(l) "Owner's Licensees" shall mean those licensees of the Owner to be
supplied with the Product by Manufacturer.
(m) "Specifications" shall mean the specifications set forth in Schedule B
hereto.
(n) "Territory" shall mean Europe, USA, Mexico, Central and Latin America.
Owner grants a first refusal right to Manufacturer for the inclusion of
Asia in the Territory.
2. LICENSE
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2.1 Owner hereby grants to Manufacturer and Manufacturer hereby accepts for
the term of this Agreement, a non-exclusive, royalty-free license to
Owner's Patents that are necessary or useful for the sole purpose of
manufacturing the Product in accordance with this Agreement. Such
rights shall be sublicensable by Manufacturer to its Subcontractors for
the sole purpose of manufacturing the Product in accordance with this
Agreement.
2.2 Owner hereby grants to Manufacturer the exclusive license rights to
manufacture, use, promote, distribute and sell the Product in Italy
under terms to be negotiated in good faith and agreed to by both
parties in a timely manner.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
2.3 The parties shall discuss in good faith the granting of a non-exclusive
license to Manufacturer's Know How and Patents to the Owner's second
supplier of Product during the term of this Agreement. If Owner
appoints a second supplier of Product and such second supplier does not
require a non-exclusive license to Manufacturer's Know How and Patents,
Owner shall have the obligation to prove to Manufacturer that the
second supplier shall not utilize any of the Manufacturer's Know How
and Patents as provided for in the NDA or in any case for the Product
and that it has obtained from FDA and/or any other competent Regulatory
authority the approval of alternative know-how, method or whatever is
necessary.
2.4 After termination of this Agreement the parties shall discuss in good
faith the granting of a non-exclusive license to Manufacturer's Know
How and Patents to the Owner or to Owner's supplier.
3. SUPPLY
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3.1 Subject to the terms and conditions of this Agreement, (i) Manufacturer
shall manufacture and supply to Owner and Owner agrees to purchase from
Manufacturer [***] percent ([***]%) of Owner's requirements of the
Product in the Territory; and (ii) Owner may, within its sole
discretion, allocate its requirements of the Product from Manufacturer
on a country-by-country and Licensee-by-Licensee basis. The Owner shall
remain responsible for the observance of the obligation to purchase
from the Manufacturer the [***]percent ([***]%) of all the requirements
of the Product, the one of the Owner itself as well as the requirement
of its Licensees.
The Owner will keep and will cause its Licensees (if any) to keep good
and accurate records in sufficient detail to permit accurate
calculation of the total requirement of the Product per each Quarter
during the term of this Agreement and to permit a proper audit thereof.
Such records will be retained by the Owner and its Licensees for a
period of 5 years after the end of the relevant Quarter.
The Manufacturer shall have the right to nominate an independent
auditor (either a certified public accountant or chartered accountant)
who may audit the records of the Owner and the records of its
Licensees, upon ten (10) days written notice, and then at a mutually
convenient time, during normal business hours no more than (i) once
during each calendar year during the term of this Agreement and (ii)
once during the twelve months following termination of this Agreement.
The costs of such audit will be borne by the Manufacturer unless the
audit discloses under-reporting in excess of five (5%) of the amount by
the Owner or its Licensees in which case the costs will be borne by the
Owner.
3.2 Following the successful completion of the dedicated manufacturing
suite for the product by Manufacturer pursuant to Article 16 and
successful review by the Regulatory Authorities in relationship to the
NDA or the initial Marketing Application in Europe, whichever is
sooner, Manufacturer shall, throughout the remaining term of this
Agreement at its sole cost and expense, establish and maintain
sufficient manufacturing facilities ("Manufacturing Facilities")
capable to meet the Product requirements of the Owner, which
Manufacturing Facilities have been validated to meet all operational,
health, environmental and other criteria mandated by the regulatory
authorities in Europe and the USA; and which Manufacturing Facilities
shall be a fully validated and licensed
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
by both the European and USA regulatory agencies for the Product prior
to the Owner obtaining regulatory approval for the Product from either
the European or USA regulatory agencies. Owner agrees to send to
Manufacturer in writing within 30 days of signing this agreement,
manufacturing specifications needed by Owner to meet USA cGMP
requirements.
3.3 Manufacturer agrees to send to Owner as soon as available a complete
written dossier containing, but not limited to, the complete chemistry
and manufacturing control of the Product for cGMP in the USA and
Europe.
3.4 Owner shall within 60 days of signing this contract supply to the
Manufacturer the written forecast of quantities of the Product to be
produced by the Manufacturer during the first 5 years of this
Agreement, for planning purposes only. The Manufacturer within 30 days
of receipt of such forecast shall supply to Owner a written plan which
the Manufacturer shall reasonably follow which will delineate the steps
the Manufacturer shall reasonably take to meet these operational
requirements. Said plan shall include but not be limited to cash,
investment, personnel, projects and time frame for each project. Owner
shall have the right to inspect the site of manufacture at any time
within normal business hours and by giving Manufacturer a reasonable
notice thereof. Manufacturer shall diligently rectify any
non-conformity as specified by Owner. Manufacturer shall diligently act
on all reasonable directions or suggestions for improvements made from
such inspections. Manufacturer shall diligently implement those
directions or suggestions necessary for regulatory approval.
Manufacturer shall permit all inspections required or demanded by
regulatory bodies and immediately begin to implement all regulatory
directions and requirements made by such regulatory bodies, so that
these directions are fully implemented on the regulatory bodies'
timeline limits. Should regulatory directions and requirements made by
such regulatory bodies after initial regulatory approval has been
granted and during the term of this Agreement imply and require
investment into the Manufacturing Facilities, which could cause
additional costs and expenses to the Manufacturer higher than
[***]percent ([***]%) of the turn-over generated by this Agreement to
the Manufacturer in the previous twelve-month period, the parties
hereto agree to discuss the matter and any possible solution in good
faith.
3.5 Manufacturer shall supply the Product to Owner in accordance with the
Specifications and any relevant cGMP in the United States of America
and Europe and at all times in a timely manner.
3.6 Manufacturer shall have the right and obligation to manufacture and
supply the Product to Owner in the amount required by the Owner, and
Owner shall have the obligation to purchase [***]percent ([***]%) of
Owner's requirements of the Product from the Manufacturer.
3.7 Owner shall have the right to establish a second site for manufacturing
the Product at its sole costs. Manufacturer shall assist Owner in this
endeavor with all reasonable necessary technical support needed to
establish this second site. All costs and expenses which Manufacturer
incurs relating to such assistance shall be borne by the Owner.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.8 Owner shall have the right hereunder to supply itself and its Licensees
with up to [***]percent ([***]%) of Owner's, and its Licensees,
requirements as determined by the Owner.
3.9. Manufacturer shall at all times maintain at its sole cost a stock of
Product conforming to Specifications equivalent to at least the mean
quantity ordered by Owner during a [***] ([***]) months period during
the previous twelve (12) months period. .
3.10 As far as practicable according to local regulatory requirement in the
Territory, on the packaging of the Product there will be printed the
following "Manufactured by Mipharm S.p.A., Milan, Italy"
4. ESTIMATED COMMERCIAL QUANTITIES AND ORDERS
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4.1 At least one hundred and twenty (120) days prior to the first day of
the months of (January, April, July and October) during which this
Agreement is in effect, Owner shall provide to Manufacturer all the
necessary technical information and written estimates of quantities of
Product to be supplied to it during the twelve-month period following
such date by month and quantity. The first three months of such
estimates shall be considered a Purchase Order.
4.2 At least ninety (90) days prior to the first day of each quarter (or
monthly, if Manufacturer may so prefer) during the term of this
Agreement (Owner shall provide in writing an irrevocable purchase order
and delivery schedule (the "Purchase Order")) for the supply to Owner
of the Product for each month during the calendar quarter then to
commence and shall provide the Manufacturer with a written estimates of
quantities of Product to be supplied to it during the twelve (12) month
period following such date.
4.3 Manufacturer shall fully comply with the Purchase Order. Owner shall
have the right to amend the quantities under the Purchase Order by up
to twenty per cent (20%) by giving Manufacturer a written notice of at
least thirty (30) days and Manufacturer shall duly comply therewith,
provided, however, that amounts of Product set forth in a Purchase
Order that exceed by more than twenty per cent (20 %) the amount
estimated for such month/ quarter in the most recent estimate of
quantities or the original Purchase Order (as the case may be), may at
Manufacturer's option be disregarded by Manufacturer. The amounts set
forth in a Purchase Order shall in no event be less than eighty per
cent (80%) of the amount of Product estimated for such month/ quarter
in the most recent written estimates of quantities.
5. DEFAULT
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5.1 If for any reason Manufacturer is or believes it will be unable to
supply the Product at the times and in the quantities ordered by Owner,
Manufacturer shall immediately inform Owner in a written notice setting
forth Manufacturer's best estimate of shortfalls in amounts and lengths
of delays. If such shortfall or delay could be considered of main
importance with respect to the delivery schedule and quantities ordered
by Owner and if Owner reasonably concludes that the delays or
shortfalls will materially affect the commercialization of the Product,
Owner shall so inform Manufacturer in a written notice.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
5.2 Upon the submission of such notice by Owner, Owner may automatically,
and without any compensation to the Manufacturer, have the right to
itself supply or appoint a third-party supplier to supply to Owner the
Product and the Manufacturer shall provide all non monetary assistance
required by Owner or such third-party to allow and enable Owner or any
of its sublicensee(s) or subcontractor(s) to manufacture the Product,
including but not limited to the manufacture and supply of the Product
pursuant to royalty-free licenses to the Manufacture's Know-How and
Patents and Inventions. The royalty-free licenses to the Manufacture's
Know-How, Patents and Inventions shall be limited to the period during
which the supply of the Product shall be made by Owner or by a third
party supplier appointed by Owner under this Article 5.2 and shall
expire upon Manufacturer's written notification as set forth in
Articles 5.3 and 5.4 below.
5.3 Upon Manufacturer's written notification and evidence to Owner that it
is able to provide the Product in accordance with this Agreement and at
the times and in the quantities estimated and/or ordered by Owner, the
Manufacturer shall supply Owner with [***]per cent ([***]%) of [***]per
cent ([***]%) of Owner's requirements of the Product. The remaining
[***]per cent ([***]%) of [***]per cent ([***]%) of Owner's
requirements of the Product may be supplied by Owner itself or the
third-party supplier. Owner shall have the right to purchase the same
[***]per cent ([***]%) of [***]per cent ([***]%) of Owner's
requirements of the Product from such third party supplier during the
remaining term of this Agreement following the date on which Owner
receives the Manufacturer's written notification and evidence to Owner
that it is able to provide the Product in accordance with this
Agreement and at the times and in the quantities estimated and/or
ordered by the Owner.
5.4 If for any reason, Manufacturer is unable to re-establish supply within
an 18 month time frame, both parties will agree to negotiate in good
faith the supply percentage requirements to be fulfilled by
Manufacturer if supply is subsequently made available.
6. QUALITY GUARANTEE
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6.1 Manufacturer hereby gives a continuing guarantee to Owner that the
Product supplied hereunder conforms to the Specifications listed in
Schedule B hereto.
6.2 Manufacturer shall promptly inform Owner about any proposed or
unannounced visit or inspection by FDA or other regulatory authority of
the facilities used by Manufacturer for the manufacture of the Product
and promptly furnish Owner with copies of all reports, documents and
correspondence received by Manufacturer in connection with any such
visit or inspection including any FDA Form 483 or similar observation
or warning letter related to the inspection.
6.3 If either party believes a recall of the Product may be necessary or
required, the party contemplating such recall shall immediately notify
the other party. Any recall shall be carried out by the Owner in as
expeditious a manner as reasonably possible to preserve the goodwill
and reputation of the Product and the goodwill and reputation of the
parties. Owner shall in all events be responsible for conducting any
recalls, market withdrawals or corrections with respect to the Product.
The cost and expense of a recall shall be allocated as follows: (a) if
such recall shall be due to Manufacturer's defect or the negligence or
the breach by Manufacturer of its warranties or obligations hereunder
or the misconduct of Manufacturer, all such costs and expenses shall be
borne and paid
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
solely by Manufacturer; (b) if such recall is due to the negligence or
the breach by Owner of its warranties or obligations hereunder or the
misconduct of Owner or if the recall is due to other causes, all such
costs and expenses shall be borne and paid solely by Owner.
6.4 Manufacturer agrees throughout the term of this Agreement to notify
Owner immediately about all available information concerning any
complaint or product defect report, whether or not it is believed to be
attributable to the Product. Owner, in consultation with Manufacturer,
shall define and implement regulatory compliance procedures for product
defect reporting and will handle all product complaints in the
Territory.
7. PRICES
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7.1 The price for the Product supplied hereunder during the first twelve
(12) months period following the first supply of Product hereunder
shall be in Euro as set forth in Schedule C.
7.2 Thereafter, the price shall be agreed to increase by no more than the
same percentage as the European Consumer Price Index. In the event of
increase of the labour cost in Italy and/or of the costs of raw
materials as resulting from the ISTAT Italian Index Price, the Price of
the Product shall be increased accordingly. The price of the Product
shall be competitive to those generally available in the market.
7.3 Owner shall assist Manufacturer to identify suppliers of active
ingredients and raw materials; provided, however, that Manufacturer
shall be solely responsible for the quality control of the active
ingredients and any other material to be used in the manufacture of the
Product, which shall at all times comply with the Specifications.
8. TERMS AND PAYMENT
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8.1 All Product supplied hereunder shall be shipped FCA Manufacturer's dock
(INCOTERMS 2000). Manufacturer shall invoice Owner in duplicate for all
Product ordered hereunder on the date of shipment. Payment for Product
supplied hereunder shall be made within thirty (30) days of shipment by
wire transfer to the bank account of Manufacturer notified in writing
to Owner in immediately available and freely transferable funds without
setoff, counterclaim or withholding whatsoever.
9. PASSAGE OF TITLE AND RISK OF LOSS
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9.1 Passage of title and risk of loss for Product furnished hereunder shall
pass to Owner at the time of delivery of the Product to Owner pursuant
to INCOTERMS 2000, subject to Manufacturer's lien for the unpaid
purchase price.
10. NONCONFORMING GOODS
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10.1 Owner shall have forty-five days (45) upon receipt of each shipment of
Product shipped pursuant to this Agreement in which to examine the
goods. If any shipment is found to fail to meet the Specifications set
forth in Schedule B hereto from any cause occurring prior to the
passing of risk in accordance with Article 9, Owner shall immediately
inform Manufacturer by a notice in writing setting forth in reasonable
detail the bases for such conclusion. For a period of fifteen (15) days
thereafter, Manufacturer shall have the right
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
to object to such conclusion, however Manufacturer shall nevertheless
supply Owner with conforming Product within sixty (60) days of receipt
of such notice from Owner. Manufacturer shall promptly thereafter
reimburse Owner the purchase price as well as for all costs, expenses
occasioned thereby, including but not limited to any customs duties,
fees or other similar payments otherwise to be made by Owner in respect
of Conforming Product to be furnished under this Article 10, recall
expenses for the return of Product shipped to Owner's customers and
related costs and expenses, unless Manufacturer has duly objected to
Owner's conclusions in accordance with the foregoing. Manufacturer's
liability in respect of goods furnished hereunder shall be limited to
the purchase price of the goods in respect of which damages are
claimed. Owner's failure to give notice of any claim within forty-five
(45) days of receipt of each shipment hereunder shall constitute an
unqualified acceptance of such goods and a waiver by Owner of any and
all claims with respect thereto, and Manufacturer's failure to give
notice objecting to Owner's conclusions within fifteen (15) days after
the receipt of Owner's notice shall constitute agreement with Owner's
conclusions. Notwithstanding the foregoing, Manufacturer shall remain
liable to Owner for any latent defect that subsequently is discovered
to render the Product purchased by Owner unsaleable or for which Owner
is obligated to replace Product in the market, if such defect is due to
the Manufacturer's failure to meet Specification and/or cGMP and under
condition that Owner immediately inform Manufacturer by a notice in
writing of such defect not later than 20 (twenty) days from the
discovery. At any time any party may refer any matter under this
Article 10 to arbitration in accordance with Article 15.
11. WARRANTIES AND INDEMNIFICATION
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11.1 Manufacturer represents and warrants that it owns all the intellectual
property related to the manufacture of the Product supplied hereunder
free and clear of any third party rights and warrants freedom from
patent infringement and from interference with any third party
intellectual property right and Manufacturer shall indemnify and hold
harmless and protect Owner against any claims, demands or costs
(including reasonable attorney's fees), liabilities and judgments
arising from any claim of patent infringement or alleged violation of
any third party intellectual property right in the manufacture of the
Product. Manufacturer shall promptly notify Owner of any such claim or
suit brought against it. Manufacturer shall indemnify and hold harmless
and protect Owner against any claims, demands or costs (including
reasonable attorney's fees), liabilities and judgments arising from any
negligence or misconduct on the part of Manufacturer or any of its
agents, Licensees, or employees, or the breach of a material provision
of this Agreement.
11.2 Manufacturer represents and warrants that the Product will comply with
the Specifications and is of a quality and purity which meet or exceed
all quality and purity requirements for the Product.
11.3 Owner shall indemnify and hold harmless and protect Manufacturer
against any claims, demands or costs (including reasonable attorney's
fees), liabilities and judgments arising from any negligence or
misconduct on the part of Owner or any of its agents, Licensees or
employees, or the breach of a material provision of this Agreement.
12. SUBCONTRACTORS
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
12.1 Subject to Owner's prior written approval, Manufacturer is hereby
authorized and empowered to appoint one or more qualified
subcontractors (a "Subcontractor") to manufacture some or all of the
Product in order to ensure Owner of a timely supply of the Product.
Manufacturer shall remain responsible for the performance of its
obligations hereunder and shall be responsible for the performance or
non-performance of each such Subcontractor and nothing herein contained
shall be construed to relieve Manufacturer of any of its obligations
hereunder.
13 FORCE MAJEURE
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13.1 In the event of war, flood, fire, strike, labor disputes, riot, act of
government authority, acts of God or other similar contingencies beyond
the reasonable control of Manufacturer directly interfering with the
supply of Product, either Party shall be relieved of its obligations
hereunder with respect to affected quantities, for so long, and for so
long only, as such contingency shall persist, but this Agreement shall
remain otherwise unaffected.
14. TERMS AND TERMINATION
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14.1 The term of this Agreement shall commence as of the date first above
written and shall continue, unless earlier terminated hereunder, for
twelve (12) years.
14.2 The initial term shall automatically renew for successive three (3)
year terms, unless terminated by either party without cause, at the end
of any term, by the giving of twelve (12) months prior written notice.
14.3 Subject to Article 5, this Agreement may be terminated by either Party
upon written notice to the other Party (a) in the event of continuing
material breach by the other Party of any of its obligations hereunder
which is not cured or which continues longer than thirty (30) days
after written notice of such breach; or (b) in the event of the
bankruptcy or insolvency of the other Party creating reasonable doubt
as to that Party's ability to perform hereunder. No such termination
shall affect or discharge any obligation of either Party which arose
prior to the effective date of such termination.
14.4 The Manufacturer shall terminate the agreement during the first 30
months in the event the quantity per year/per remaining six month
period of the Product purchased by the Owner directly or thorough its
Licensees is less than the fifty per cent (50%) of the forecast
submitted to the Manufacturer according to Article 3.3 with reference
to the quantity indicated for the relevant year/remaining six month
period for the first 30 month period of such forecast.
14.5 Upon termination of this Agreement, Owner shall purchase and pay for
all conforming Product produced by Manufacturer pursuant to the
estimates provided by Owner pursuant to article 4.2 hereof, at the
price set forth in Schedule C hereof, and shall purchase from
Manufacturer all intermediates purchased by Manufacturer in
contemplation of providing the Product pursuant to the estimates
provided by Owner pursuant to Article 4 hereof at seller's cost of such
intermediates.
14.6 The provisions of Articles 1(c), 2.4 3.1, 6.1, 6.3, 8.1, 10.1, 11,
14.5, 15, and 16, shall survive termination of this Agreement.
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15. DISPUTE RESOLUTION
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15.1 Both parties will use their best endeavors to settle all matters in
dispute amicably. All disputes and differences of any kind related to
this Agreement, which cannot be solved amicably by the parties, shall
be referred to arbitration by either party.
15.2 Any arbitration that is invoked will be heard before a panel consisting
of three arbitrators. The arbitration, including the appointment of the
arbitrators, shall be carried out in accordance with the rules of the
International Chamber of Commerce. The arbitration shall take place in
Geneva and shall be conducted in the English language. The award of the
arbitrators shall be rendered within six (6) months from referral,
shall contain findings of fact and conclusions of law, and the award
shall be final and binding on both parties. The parties bind themselves
to carry out the award of the arbitrators.
15.3 This Agreement shall be construed and interpreted pursuant to the Laws
of the State of New York without regard to its rules on conflicts of
law. The parties agree that the United Nations Convention on Contracts
for the International Sale of Goods shall not apply to the
interpretation and construction of this Agreement.
16. OWNER'S SPECIAL OBLIGATIONS.
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16.1 Owner acknowledges that Manufacturer has made and is making several
investments with the purpose to arrange, equip, test and validate the
Manufacturing Facilities for the manufacturing of the Product according
to the applicable Laws and Regulations. Manufacturer will make
commercially reasonable efforts to complete the Manufacturing
Facilities for the manufacturing of the Product in a timely manner.
Owner acknowledges that according to the manufacturing specifications
of the Product disclosed to Manufacturer at the Effective Date the
necessary timing estimated by Manufacturer to complete the dedicated
Manufacturing Facilities for the manufacturing of the Product provides
for the completion of the Manufacturing Facilities not before April
1st, 2003.
16.2 In consideration of the above, Owner shall pay to Manufacturer up to
[***]the documented cost of establishing a dedicated manufacturing
suite for the Product to be paid as follows:
16.2.1 $[***]upon execution of this Agreement;
16.2.2 $[***]upon filing the NDA and/or the initial Marketing
Application in Europe, whichever is sooner;
16.2.3 $[***]upon successful completion of the dedicated manufacturing
suite for the Product by Manufacturer and successful review by the
Regulatory Authorities in relationship to the NDA;
16.2.4 the remaining part of costs up to [***]the documented costs upon
final approval of the NDA.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
16.3 Payments due according to this Article 16 shall be increased by the
Italian VAT, if applicable. The first three payments shall be made by
Owner to Manufacturer immediately upon the occurrence of each
individual milestone specified under Articles 16.2.1, 16.2.2, and
16.2.3.
16.4 Manufacturer shall keep complete and accurate records of expenses
related to the dedicated manufacturing suite for the Product in
sufficient detail to permit Owner to confirm their completeness and
accuracy. Upon completion of the dedicated manufacturing suite,
Manufacturer shall permit Owner and Owner's independent, certified
public accountant or chartered accountant (reasonably acceptable to
Manufacturer) to inspect those records of Manufacturer that relate to
the dedicated manufacturing suite for the Product for the sole purpose
of verifying the accuracy of the expenses. Such inspection shall be at
Owner's expense and shall be subject to reasonable advance notice to
Manufacturer, during Manufacturer's usual business hours. If the
accountant finds that an additional payment up to one-half the
documented costs is due from Owner to Manufacturer, Owner shall make
such payment upon the occurrence of the milestone specified in Article
16.2.4. If the accountant finds that a refund is due from Manufacturer
to Owner under this Article 16, the Manufacturer shall pay it to Owner
immediately.
16.5 Except in the case of a breach of this Agreement by Manufacturer during
the first three (3) years from the Effective Date, or as otherwise
provided in Article 16.4, payments under this Article 16 by Owner are
not refundable to Owner for any reason whatsoever, including
termination of this Agreement.
17. NOTICES
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17.1 All notices, requests or other communications hereunder shall be deemed
to have been duly given on the date indicated when delivered or
telefaxed to the other Party at the following address:
If to Mipharm:
MIPHARM S.p.A.
Via B. Quaranta, 12 - 20141 Milano Italy
Attention to: Dr. Giuseppe G. Miglio - Chairman and C.E.O.
Fax number: +30 02 53548051
If to Columbia:
Columbia Laboratories (Bermuda), Ltd.
P.O. Box HM 1179
Cedar House
41 Cedar Avenue
Hamilton HM 12
Bermuda
Tel: (441) 295-2244
Fax: (441) 292-8666
(441) 295-5328
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
With paper copy being sent by certified first class mail - postage
prepaid - or by express delivery service) to the address indicated
above or such other address as it shall designate by written notice
given to the other Party.
18. MISCELLANEOUS
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18.1 This Agreement may not be assigned by either Party without the written
consent of the other Party, which may not be unreasonably withheld.
However, each Party may assign this Agreement, without the consent of
the other party, to any of its Affiliates or to any purchaser of all or
substantially all of its assets to which this Agreement relates or to
any successor corporation resulting from any merger, consolidation or
restructuring of the party; provided, however, such assignment shall
not release the assigning Party from any obligations under this
Agreement. Any assignment in violation of this Agreement shall be null
and void.
18.2 In case of any change in the control of the Owner and of any merger or
acquisition involving the Owner, the same will previously inform the
Manufacturer of the identity of the involved third party; in this event
the present Supply Agreement shall survive and the new party resulting
from the merger, acquisition etc will automatically be bound by the
terms and conditions of this Supply Agreement.
18.3 In case of assignment of the rights on the Product by the Owner to any
third party, the Owner shall previously inform the third party about
the existence of this Supply Agreement and shall be responsible to
procure that the third party unconditionally accepts to take it over
and to be bound by all its terms and conditions.
18.4 This Agreement may be amended or modified only by a written instrument
executed by all of the Parties hereto.
18.5 The paragraph headings contained herein are for reference only; they
are not a part of this Agreement nor shall they in any way affect the
interpretation thereof.
18.6 No term or provision hereof shall be deemed waived and no breach
excused, unless such waiver or consent is in writing and signed by the
Party claimed to have waived or consented. Such express waiver by
either Party of a breach of any provision of this Agreement shall not
constitute a continuing waiver of other breaches of the same or other
provisions of this Agreement.
18.7 Any provision of this Agreement which is prohibited, unenforceable or
not authorized in any jurisdiction shall, as to such jurisdiction, be
ineffective to the extent of such prohibition, unenforceability or
non-authorization without invalidating the remaining provisions hereof
or effecting the validity, enforceability or legality of such provision
in any other jurisdiction.
18.8 Nothing herein shall be construed as creating any joint venture,
partnership or agency relationship between the Parties hereto. Each of
the Parties is an independent contractor hereunder and neither is
authorized to make any commitments of any kind or to take any action
which shall be binding on the other.
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18.9 This Agreement is executed in two counterparts, each of which shall be
deemed an original and both of which when taken together shall
constitute but one and the same agreement.
18.10 This Agreement sets forth the entire agreement between the Parties and
merges and supersedes all previous understandings and agreements
between the Parties whether written or oral with respect to the subject
matter hereof. This Agreement may only be amended by a written
instrument duly executed by both Parties
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed
by their duly authorized representatives as of the date first above written.
Mipharm S.p.A. Columbia Laboratories (Bermuda) Limited
/S/ Giuseppe G. Miglio /S/ G. Frederick Wilkinson
- ---------------------- --------------------------
Giuseppe G. Miglio G. Frederick Wilkinson
Chairman and CEO President
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
SCHEDULE A
OWNER'S PATENTS
EPO Patent Application No. 99053815
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
SCHEDULE B
PRODUCT SPECIFICATIONS
The Product will conform, on a country by country basis, to the specifications
approved in the applicable Marketing Authorization by the regulatory
authorities for that country.
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SCHEDULE C
PRICE
TESTOSTERONE BUCCAL TABLETS 30 mg
60 tablet pack
6 blisters - 10 tablets each
Ex-works price: Euro [***]= ((euro)[***])
Per Units/year: [***]
Minimum Batch: [***]units
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.