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Exhibit 10.1
Confidential Materials omitted and filed
separately with the
Securities and Exchange Commission.
Asterisks denote omissions.
Product License and Supply Agreement
Parties
This Product License and Supply Agreement (the "Agreement") is
effective January 1, 2007 (the "Effective Date"), by and
between
CollaGenex Pharmaceuticals, Inc. with offices at 41 University
Drive, Newtown, Pennsylvania 18940, USA ("CollaGenex"), and
MediGene AG, with offices at Lochhamer Strasse 11, DE82152
Planegg/Martinsried, Germany ("MediGene").
Recitals
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WHEREAS , CollaGenex filed and on 27 May, 2006 the U.S. Food and
Drug Administration approved, New Drug Application 50/805 covering
the marketing and sale of a 40mg controlled release doxycycline
monohydrate capsule conforming to the specifications described in
such application (such product being referred to as the "Product"),
and
WHEREAS , CollaGenex filed a Request for Marketing
Authorisation for the Product with the U.K. Medicines and
Healthcare Regulatory Agency on February 27, 2006 under file number
PL 27682/0001 (the "RMA") pursuant to the decentralized approval
procedure of the European Community, identifying as concerned
member states those countries identified with an *asterisk on
Exhibit A, and at or about the same time filed a national
application seeking marketing authorization for the Product in
Switzerland;
WHEREAS, CollaGenex is the owner or licensee of various
Patents and Trademarks more fully set out below, which cover the
Product;
WHEREAS, MediGene intends to build a direct sales force
to specialize in the sale of pharmaceuticals used to treat
dermatological indications, which sales force will directly call on
dermatologists in selected countries in the Territory (as defined
below) and intends to sublicense the manufacture, marketing,
distribution and sale of the Product in the other countries in the
Territory; and
WHEREAS, CollaGenex wishes to license the right to
manufacture, market, distribute and sell the Product in the
Territory and MediGene is willing and able to so and wishes to
accept such license.
CollaGenex and MediGene (each a "Party") Agree As
Follows:
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In this Agreement, the following terms appear as defined terms
in more than one place and have the meanings ascribed to them in
the following sections or paragraphs:
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Agreement
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Preamble
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Annual Accounting Period
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3(b)
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Batch
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7(d)
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Business Day
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7(e)
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Calendar Day
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4(e)
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CollaGenex
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Preamble
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Confidential Information
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19
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Cure Payment
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16(b)(i)
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Force Majeure
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Know How
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2(c)
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License
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1 (a)
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Licensed Assets
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1(a)
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Losses
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22 (e)
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MediGene
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Preamble
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Minimum Sales
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5(c)
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Net Sales
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4(d)
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Party(ies)
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Preamble
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Patent(s)
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2(a)
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Payment
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14(b)
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Product(s)
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Preamble
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Product Data
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2(d)
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Product Know How
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2(c)
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Purchase Period
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7(a)
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Quarterly Report
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4(e)
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RMA
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Preamble
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RMA Approval
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4(c)
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Specifications
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7(b)
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Technology Transfer Agreement
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12(d)
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Term
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16(a)
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Territory
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1(d)
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Trade Mark
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2(b)
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Transfer Price
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8(a)
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1.
Grant of License .
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(a)
Exclusive License. CollaGenex
grants to MediGene an exclusive royalty bearing license and, as the
case may be, an exclusive royalty bearing sublicense (the
"License") under the Patents, the Trademarks, the Product Know-How
and the Product Data (all as defined below and collectively
referred to as the "Licensed Assets") to the extent necessary to
obtain marketing authorisations for, and to manufacture, have
manufactured, to market, have marketed, to distribute, have
distributed, and to sell and have sold the Product in the field of
dermatology in the Territory.
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(b)
Right to Sublicense. All
licenses granted under this Agreement shall include the right to
grant sublicenses subject to the appropriate terms hereof being
accepted by any sublicensee, and on the express understanding that
any such sublicense shall not affect the performance or other
obligations of MediGene hereunder.
(c)
Exclusivity. CollaGenex shall not
itself, and shall not authorise any other party to, market,
distribute, or sell the Product in the Territory, nor will
CollaGenex market, distribute or sell in the Territory any other
systemic product approved for the treatment of acne or rosacea and
having as its active ingredient doxycycline. Nothing in this
paragraph shall preclude CollaGenex from authorizing any other
party to, or itself deciding to, develop or market or sell in the
Territory a systemic product approved for the treatment of a
clinical indication outside dermatology and having as its active
ingredient doxycycline.
(d)
Territory. The "Territory" shall
mean those countries listed on Exhibit A. MediGene shall not sell
the Products outside the Territory, nor to any other person that -
to MediGene’s best knowledge - is selling or that intends to
sell the Products outside the Territory.
(e)
Imports Into Territory. CollaGenex
shall use its best efforts to ensure that Products are not imported
into the Territory from any other geography and shall immediately
respond to any report of such activity and shall take appropriate
measures to halt it.
(f)
Non-Compete; Non-solicitation.
MediGene agrees that, in consideration for receiving and acquiring
this License, it will not, for the term of this Agreement and for a
period of one year thereafter, except in case of expiration of the
Agreement according to sec. 16(a), market, distribute or sell any
product which is an oral systemic therapy for dermatological
conditions containing doxycycline or any chemically modified
tetracyclines, neither will it solicit the employment of any
employee of CollaGenex.
2.
Licensed Assets .
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(a)
Patents. The "Patents" covered by
this Agreement include all the patents and patent applications,
utility models and designs related to the Product as of the
Effective Date and at any time during the Term of this Agreement,
which are necessary or appropriate to market, distribute, sell and
manufacture the Product in the Territory, which are under control
of CollaGenex. The patents and patent applications as of the
Effective Date are listed and grouped on Exhibit B and
include
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(ii)
The Supernus Patent(s), of which CollaGenex is the
exclusive licensee in the field of dermatology, and to which
CollaGenex grants MediGene a sublicense pursuant to this
Agreement;
(iii)
The CollaGenex Patents, of which CollaGenex is the
owner and to which CollaGenex grants MediGene a license pursuant to
this Agreement.
Included in the Patents are furthermore corresponding foreign
intellectual property rights having the same priority dates and
patent applications that claim priority in whole or in part from
the specified foreign intellectual property rights including but
not limited to continuations, continuations-in-part, divisionals,
reexaminations and reissues of such foreign intellectual property
rights.
(b)
Trademarks. The "Trademarks"
covered by this Agreement include all the trademarks listed on
Exhibit B, provided, however, that CollaGenex grants MediGene the
right but does not impose on it the obligation to use such
trademarks for the purpose of promoting the Products.
CollaGenex may at any time remove any Trademark from Exhibit B upon
notice to MediGene if, at such time, MediGene has not informed
CollaGenex of its intention to use such Trademark. MediGene
shall be free to use its own trademarks for the purpose of
marketing, distribution, sale and manufacturing of the
Products. If MediGene elects to use the Trademarks, it shall
use them only in connection with the promotion of the Products and
shall not alter, modify or otherwise change the Trademarks. If
changes to or of Trademarks are necessary due to legal, regulatory
or other aspects based on a good faith determination by MediGene,
Parties will jointly discuss how to implement such changes without
diminishing the goodwill attaching to any Trademark anywhere in the
world and in light of such discussions CollaGenex will not
unreasonably withhold approval to such changes. CollaGenex
further agrees that MediGene may use its own name and logo in
connection with such trademarks, provided that the manner of such
use has first been approved by CollaGenex, such approval not
unreasonably withheld or delayed. Nothing in this limited grant of
rights shall imply that either Party acquires, nor will it acquire,
any further rights whatever in or to the trademarks or trade names
of the other Party
(c)
Product Know-How. The "Product Know-How"
covered by this agreement means all Know-How (as defined below)
related to the Product which is under control of CollaGenex as of
the Effective Date or is created during this Agreement, which is
not covered by the Patents but is necessary or useful to market,
distribute, sell or manufacture the Product. As used in this
Agreement, "Know-How" shall mean tangible and
intangible: techniques, technology, practices, trade secrets,
discoveries, inventions, methods, formulas, knowledge, know-how,
skill, experience, tests, assays, test data and results (including
pharmacological, toxicological, pre-clinical and clinical test data
and results), technical, non-technical, analytical and quality
control data, results or descriptions, drawings, plans, diagrams,
software and algorithms.
(d)
Product Data The "Product Data"
covered by this Agreement shall include all the data included in
the RMA, and such other data referenced therein or otherwise under
the control of CollaGenex relating to the development,
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3.
Consideration .
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(a)
Execution Payment. In consideration
for the grant of the above license, MediGene will pay U.S. $5
million to CollaGenex within 30 days after execution of this
Agreement.
(b)
First Sales Milestone. MediGene
will pay CollaGenex U.S. $[**] when aggregate revenues
required by GAAP to be reported from sales of the Product in the
Territory for the first time exceed U.S. $[**] in any twelve month
period adopted by MediGene as a financial year for purposes of its
financial reporting (an "Annual Accounting Period").
(c)
Second Sales Milestone. MediGene
will pay CollaGenex U.S. $[**] when aggregate revenues
required by GAAP to be reported from sales of the Product in the
Territory for the first time exceed U.S. $[**] in any Annual
Accounting Period, provided, however, that in the event that both
the first and the second sales milestones described in Sections 3
(b) and 3(c) occur are passed in the same Annual Accounting Period,
both milestone payments, for a combined amount of U.S. $7.5
million, would be payable in the same Annual Accounting Period. For
the avoidance of doubt the Milestone payments under Sec. 3 (b) and
3 (c) shall under no circumstances exceed the aggregate amount of
U.S. $ 7.5 million.
(d)
Accounts and Exchange Rate.
Payments according to Sec. 3 (b) an 3 (c) shall be paid within 30
days after the annual accounts of MediGene have been audited by the
certified public accountant of MediGene. All Payments hereunder
shall be payable in united States dollars using the arithmetic
average of the daily exchange rates (U.S.$/€) during the
Annual Accounting Period, for which a milestone payment shall be
made, taken from the Wall Street Journal, Eastern U.S. Edition or,
if such exchange rates are not available with respect to any given
day, from Reuters Daily Rate Report.
(e)
Russian Milestone. MediGene will pay
CollaGenex [**] of any lumpsum payments received from distributors
or sub-licensees within 3 years of the execution of a sub-license
or similar agreement providing such distributor or sublicensee with
the right to market and sell the Product in Russia. Such payments
shall be made to CollaGenex within 30 days of receipt by MediGene
of the corresponding payment.
4.
Royalties .
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(b)
Renegotiation of Royalty. For so
long as MediGene does not exercise its right to manufacture, the
above rates may be renegotiated if the Transfer Price (as defined
below) exceeds [**]% of average unit sales price required by GAAP
to be reported from sales of the Products in those countries
identified as Concerned Member States in the RMA in any Annual
Accounting Period.
(c)
Minimum Royalties. At any time
after CollaGenex has obtained "RMA Approval" (being the national
marketing authorisation in Germany and U.K.) royalties payable to
CollaGenex shall be no less than:
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(i)
U.S. $[**] in the Annual Accounting Period relating
predominantly to 2007,
(ii)
U.S. $[**] in the Annual Accounting Period relating
predominantly to 2008;
(iii)
U. S. $[**] in the Annual Accounting Period relating
predominantly to 2009, and in all Annual Accounting Periods
thereafter.
provided, however, that the amounts may be reduced in the manner
set out in the attached Exhibit D if RMA Approval is not obtained
before [**];
(d)
Net Sales. For the purposes of this
Agreement, "Net Sales" shall mean aggregate amounts received from
sales of the Products in the Territory by MediGene or its
sublicensees, less all trade or quantity discounts or rebates
actually allowed, discounts or rebates actually allowed to
government or non-government healthcare providing or g
anizations, returns, and prompt payment discounts, calculated
according to GAAP consistently applied.
(e)
Reports. Within [**] Business Days
of the end of each [**], MediGene shall provide CollaGenex with a
non-binding pro-forma estimate of Net Sales of the Product in the
Territory during such [**]. Within [**] calendar days (each
day counted on the calendar being considered a "Calendar Day"
whether or not business is conducted on such day) of the end of
each calendar [**] (or whatever [**] date MediGene shall adopt for
purposes of its financial reporting), MediGene shall submit to
CollaGenex a report setting out the prescriptions, unit sales and
selling prices of the Product in the Territory in such [**] in
sufficient detail, but not including any customer data, to
substantiate its calculation of the royalty payable in respect of
such [**] (the "[**] Report").
(f)
Payments and Exchange Rate. All
payments required under this Section shall be calculated in Euros
and made in United States dollars using the arithmetic average of
the daily exchange rates (e.g., Dollar/Euro), during the quarterly
accounting period covered by the relevant royalty calculation,
taken from The Wall Street Journal , Eastern U.S. Edition
or, if such exchange rates are not
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available with respect to any given day, from the
Reuters Daily Rate Report . Such amounts will then be
delivered for deposit to the account or accounts specified from
time to time by CollaGenex within 60 Calendar Days of the end of
the quarter in which they became due. The shortfall, if any,
between paid royalties and Minimum Royalties, will be paid
together with the royalty payment for the fourth quarter of each
Annual Accounting Period.
(g)
Withholding Taxes. MediGene shall
be responsible for paying and for accounting for all withholding or
other taxes for which the payor of any of the payments described
above is legally responsible, and shall fully document any such
payment which diminishes the amount of royalty or other payments
due to CollaGenex.
(h)
Right to Audit. MediGene shall keep
records in sufficient detail to permit the determination of Net
Sales and royalties payable under this Agreement and, at the
request and expense of CollaGenex, shall permit an independent
certified public accountant, reasonably acceptable to both parties,
to examine, in confidence, during ordinary business hours once in
each Annual Accounting Period, subject to a thirty (30) day written
notice by CollaGenex thereof, such records as may be necessary to
verify or determine royalties or other payments paid or payable
under this Agreement. CollaGenex shall pay for such audits
and inspections, except that in the event that any such audit
covering at least four (4) calendar quarters reveals that, during
the period covered by the audit, MediGene paid to CollaGenex less
than ninety-five percent (95%) of the aggregate amount of Royalties
that were due to CollaGenex with respect to such period, MediGene
shall be obligated to reimburse CollaGenex for the reasonable
out-of-pocket costs incurred by CollaGenex with respect to such
audit.
5.
MediGene Promotional Obligations .
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(a)
Sales Force. MediGene will, at its
own expense, maintain, manage and compensate a direct sales force
or a contractual sales force that calls on dermatologists in the
Territory and at all times is believed by MediGene to be sufficient
to achieve in excess of the Minimum Sales set out below.
MediGene shall ensure that such sales force is trained in the
promotion and sale of the Product. All costs related to the
training of the sales force shall be borne by MediGene.
(b)
Promotion. MediGene shall use all
reasonable legal efforts to promote and sell the Products in the
Territory. MediGene will be responsible at its own expense
for designing and producing all promotional materials in compliance
with applicable EU directives, provided, however, that CollaGenex
shall make available to MediGene upon request examples of all
promotional materials used by CollaGenex to promote the Product
outside the Territory.
(c)
Minimum Sales . MediGene shall
achieve, subject to CollaGenex’s diligent and timely
fulfillment of obligations under this Agreement, at least the
following
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aggregate levels of Net Sales of the Products in the
Territory, during the following time periods (the "Minimum
Sales"):
Annual Accounting Period relating predominantly to
2009
$[**]
Annual Accounting Periods after 2009 up to and until competition
by systemic antibiotic products with submicrobial formulations or
applications, including but not limited to incyclinide, is launched
in the
Territory $[**]
provided, however, that these amounts may be [**] in the manner
set out in the attached ExhibitD if RMA Approval is not obtained
before [**]
The failure to achieve the Minimum Sales in 2009 or any
subsequent Annual Accounting Period in which Minimum Sales have to
be achieved shall trigger CollaGenex’s right of termination
set out in Section 16 (b) (i).
6.
Marketing Authorisations
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(a)
RMA Approval.
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(i)
CollaGenex will use reasonable best efforts to
achieve RMA Approval.
(ii)
In case that RMA Approval is granted as a
conditional approval any reasonable costs and expenses arising in
connection with or fulfilling the conditions attached to such
approval shall be borne
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(A)
solely by CollaGenex if such condition is to be
fulfilled prior to sale of the Product in Germany or U.K.
or
(B)
as follows if such condition is to be fulfilled
subsequent to approval and sale of the Product in Germany or
U.K.:
(aa) the first $
[**].- shall be borne solely by CollaGenex;
(bb) the next $
[**].- shall be borne solely by MediGene;
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provided, however, that if MediGene reasonably estimates that
the cost of fulfilling any post-approval condition will exceed $
[**].-, MediGene shall have the right, at any time, during a period
of [**] days following the announcement of a post approval
condition, to refuse to fund the fulfillment of such post approval
condition, in which case all of its rights and obligations under
this Agreement with respect to the country requiring such post
approval condition shall terminate.
(iii)
CollaGenex warrants, that it will promptly transfer
on a country-by-country basis to MediGene all the national
marketing authorisations that CollaGenex obtains in the Territory;
provided, however, that if transfer of
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such marketing authorisations is for any reason not
permitted, CollaGenex will use best efforts to provide MediGene
with all the rights necessary to carry out the activities
contemplated by this Agreement. At the time of each such
transfer, MediGene shall assume the responsibilities of a marketing
authorisation holder in the relevant country. CollaGenex shall
provide MediGene with copies of or access to all the documents
received by CollaGenex in connection with achieving of or applying
for national marketing authorisations, together with such clinical
documentation and clinical results as may be needed by MediGene
(including its affiliates or sublicensees) to fulfill its
obligations under this Agreement and to comply with applicable laws
in the Territory.
(iv)
Immediately following RMA Approval CollaGenex will
transfer to MediGene the sponsorship of all national marketing
authorisations that are pending at that time, provided, however,
that if transfer of such marketing authorisations is for any reason
not permitted, CollaGenex will use best efforts to provide MediGene
with all the rights necessary to carry out the activities
contemplated by this Agreement.
(b)
Further Marketing Authorisations
[**] days after receipt of RMA Approval, MediGene shall formulate,
submit to CollaGenex, and begin diligently to pursue a plan for
obtaining marketing authorisations for the Product [**]. Such plan
shall be subject to approval by CollaGenex (such approval not to be
unreasonably withheld). In the event that MediGene fails for any
reason to put together a plan that meets with CollaGenex’s
reasonable approval with respect to any country, or fails to obtain
a marketing authorisation in any country specified in the approved
plan within the time frame set out for such country in the plan,
then CollaGenex shall have the right itself, or through a third
party, on a co-exclusive basis to seek a marketing authorization in
such country and to market and sell the Product in such
country.
(c)
Specifications. In its dealings with
regulatory agencies in the Territory in connection with obtaining
or maintaining marketing authorisations, MediGene shall not agree
to any changes in the Specifications for the Product without
obtaining advance written approval of CollaGenex, pursuant to the
notice procedure specified in Section 21.
(d)
Pricing Negotiations.
MediGene shall be responsible for pricing and reimbursement
negotiations with relevant authorities and private-sector
pharmaceutical benefit management organizations in the
Territory.
(e)
Status Reports. In its Quarterly
Reports MediGene shall inform CollaGenex each quarter of the status
of (i) its efforts to obtain marketing authorisations in the
Territory and (ii) pricing and reimbursement negotiations for
authorised products in the Territory.
(f)
Cooperation in Regulatory Affairs . Upon
reasonable advance notice each Party agrees to make its employees
and non-employee consultants reasonably available (up to 40
hours per year) at their respective places of employment to consult
with the other Party on issues arising in connection with any
request
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from any regulatory agency, including , without
limitation, regulatory, scientific, technical and clinical
testing.
(g)
Maintenance of Marketing Authorisations.
At the time of receiving the transfer from CollaGenex of any
marketing authorization, or of itself obtaining any marketing
authorisation, MediGene shall assume the reponsibilities of
Marketing Authorisation Holder in the relevant country and will, at
its sole cost and expense, maintain all such marketing
authorisations or other rights, including obtaining any variations
or renewals thereof and paying any license or other fees required
as part of such maintenance.
(h)
Registration Dossiers. CollaGenex
shall have the right of full access at any time to any of the
registration dossiers of MediGene, including stability and all
other data associated with the Product, to enable CollaGenex (or an
affiliate of CollaGenex or an authorised regulatory agent of
CollaGenex) to utilise the data contained therein for any
registration applications that CollaGenex may wish to make in any
jurisdiction for any product for clinical indications outside
dermatology.
(i)
Adverse Drug Event Reporting. Parties will
enter into a separate agreement concerning Adverse Drug Event
Reporting reflecting the requirements of applicable laws and
regulations.
7.
Manufacture, Purchase and Supply of Product
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(a)
Purchases. Until MediGene has
exercised its right to manufacture and executed the Technology
Transfer Agreement pursuant to Section 12 of this Agreement, and
additionally thereafter for any transitional period provided in the
Technology Transfer Agreement (such entire period being referred to
as the "Purchase Period"), MediGene shall purchase the Product
exclusively from CollaGenex and CollaGenex agrees to manufacture or
have manufactured and sell the Product exclusively for and to
MediGene during the Term of this Agreement for sale of Product in
the Territory.
(b)
Quality Assurance. CollaGenex shall
manufacture or have manufactured the Product in accordance with the
specifications set forth in the approval of the marketing
authorisations in the Territory (the "Specifications"), all laws
and guidelines that apply to it or its operations, Good
Manufacturing Practices (including European GMP) and applicable
laws, guidelines and regulations referenced in the marketing
authorisation issued by the reference member state, provided,
however, that any additional costs incurred in conforming to such
Specifications, practices or guidelines, to the extent they deviate
from the specifications of the Product set forth in the FDA
approval relating to NDA 50/805, shall be borne by MediGene.
However, if those additional costs include set up or other costs
prior to initiation of manufacture that are estimated by MediGene
as likely to exceed $ 1,000,000.-, then MediGene shall have the
right to terminate this Agreement pursuant to section 16 (c) (v).
CollaGenex shall not, without prior written notice to MediGene,
change its current contract
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manufacturer Cardinal Health and will not delegate,
assign, or otherwise contract out to any other person any
portion of manufacturing.
(c)
Forecasting. MediGene shall
provide CollaGenex with a rolling twelve month non-binding forecast
of anticipated quantities and order dates for Products. Such
forecast shall be updated and submitted quarterly, within the [**]
day period following the end of each quarterly accounting
period. CollaGenex will use reasonable commercial efforts to
meet orders for Products that exceed the forecast, but shall incur
no liability if it is unable to do so.
(d)
Batch Size. Purchase Orders shall
be in multiples of [**] Batches, with one batch having the size of
approximately [**] capsules (a "Batch"), packed into [**] drums
each weighing approximately [**].
(e)
Order and Acceptance. MediGene
shall place orders for Product with CollaGenex from time to time,
not less than [**] Calendar Days prior to the requested date of
delivery, on the terms and conditions of this Agreement, which
shall have precedence over the terms of any purchase order issued
by either party, save in respect of quantities, prices, and
delivery dates. CollaGenex shall acknowledge every order it
receives. Although no order shall be binding unless and until
accepted by CollaGenex, provided that CollaGenex shall be obliged
to accept orders at least once per quarter that do not exceed the
applicable forecast or one Batch. CollaGenex shall notify
MediGene within [**] business Business Days [**] of receipt
regarding the acceptance or rejection of a purchase order. Accepted
purchase orders shall be binding (a "Business Day" being a day on
which the banks are open for business in both Newtown, Pennsylvania
and Munich).
(f)
Labeling and Packaging .
MediGene shall label and package all Product in accordance with the
applicable marketing authorisation and with all other requirements
under laws applicable to importing, marketing, distribution and
sale in the Territory, and shall be responsible, at its own
expense, for validating all packaging and handling facilities
necessary to complete this process, and paying all fees associated
therewith.
(g)
Sufficient Quantities. MediGene shall
maintain, subject to availability and delivery from CollaGenex,
sufficient stock of Products to respond to customer demand without
delay at all times, and as a minimum shall keep sufficient
quantities in stock to supply [**] months of projected
sales.
(h)
Storage. MediGene shall
store the Product in accordance with the provisions of applicable
marketing authorisations and in accordance with the requirements
pertaining to the storage of human pharmaceutical products from
time to time in force in the Territory, including the Guidelines on
Good Distribution Practices adopted from time to time by the
European Commission.
(i)
Delivery and Risk of Loss. The terms of
delivery from CollaGenex to MediGene shall be "ex works
CollaGenex’s (or its manufacturer’s) warehouse" as
defined in Incoterms 2000, and ownership and risk of loss shall
pass to MediGene accordingly.
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(j)
Delay. CollaGenex shall promptly
provide MediGene with as much notice in writing as possible of a
potential delay in supply of the Product and such notice shall
explain fully the reason for such delay. The Parties shall then
discuss how the delay may be minimized or avoided.
(k)
Remaining Shelf Life. Product delivered to
MediGene must have a remaining shelf life of at least [**]% of the
shelf life acknowledged by a competent authority. Initially
this remaining shelf life shall not be less than [**]
months.
8.
Transfer Price of Product
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(a)
Transfer Price. Unless
otherwise agreed upon in writing between the Parties, the price of
the Products when sold by CollaGenex to MediGene (the "Transfer
Price") shall be US $ [**] per capsule. This price is approximately
equivalent to [**]% of the price currently paid by CollaGenex to
its contract manufacturer.
(b)
Price Increase. The price of
the Product may be increased by CollaGenex from time to time, but
not more than [**], by giving notice to MediGene [**] Calendar Days
prior to the date scheduled for such change, provided, however,
that the Transfer Price resulting from any such increase shall not
exceed the greater of
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(i)
The [**] multiplied by the [**] in the producer
price index published by the United States department of Labor over
the applicable twelve month period; or
(ii)
[**]% of the price paid by CollaGenex to its
contract manufacturer for the Product.
(c)
Payment Terms. Invoices for
Products supplied under this Agreement shall be payable by MediGene
net [**] Calendar Days from the date of delivery, by bank transfer
to such account as CollaGenex shall specify in writing.
(d)
Taxes. All sales, use, transfer and
other taxes including VAT and duties imposed with respect to the
Products or their sale by CollaGenex to MediGene shall be paid by
MediGene, and shall not diminish or be deducted from the amount of
payments due to CollaGenex.
9.
Product Documentation and Inspection
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(a)
Certificate of Analysis. Each Batch
of Product shipped to MediGene shall be accompanied by a
Certificate of Analysis and a certificate of compliance or release
certificate that confirms conformity of the Product with the
Specifications and that the Product was manufactured and
tested in compliance with the Specifications, applicable laws and
recognised pharmaceutical rules. Disposition showing the date of
manufacture and the expiry date of the Products.
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(b)
Inspection upon delivery . MediGene
shall inspect each delivery of the Product within [**] Business
Days of receipt at MediGene’s premises (or at the premises of
its authorised representative) and shall notify CollaGenex by
facsimile, with a hard copy by airmail, within [**] Business Days
of such inspection of any shorta
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