Exhibit
10.52
*** CERTAIN
CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY
ASTERISKS) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER 17 C.F.R. SECTIONS 200.80(B)(4),
200.83 AND 230.406.
AMENDED AND
RESTATED
UNITED
STATES
DISTRIBUTION
AGREEMENT
THIS AMENDED AND RESTATED UNITED STATES DISTRIBUTION
AGREEMENT (this “Agreement”) is made as of the 29th
day of November, 2004 by and between GENZYME CORPORATION , a
corporation duly organized and existing under the laws of the
Commonwealth of Massachusetts (“Genzyme”) and INAMED
MEDICAL PRODUCTS CORPORATION , a corporation duly organized and
existing under the laws of the State of California (the
“Distributor”).
WHEREAS, Genzyme, as assignee of and successor in interest
to Biomatrix, Inc. and Inamed, as assignee of an successor in
interest to Collagen Corporation, on June 14, 1996 entered into a
United States Distribution Agreement (the “Original
Agreement”), as amended by Genzyme and Inamed on September
30, 2002 by the Development Agreement and Amendment to United
States Distribution Agreement (the “Development Agreement and
Amendment”), pursuant to which Genzyme granted to Inamed
exclusive promotion, marketing and distribution rights for certain
products in the United States on the terms and subject to the
conditions set forth therein; and
WHEREAS , Genzyme and the Distributor wish to amend and
restate the Original Agreement, as amended, in order to include
certain additional products as Agreement Products (as such term is
hereinafter defined), and to make such further amendments upon the
terms and conditions set forth in this Agreement, which
incorporates in its entirety the Original Agreement and Section 16
of the Development Agreement and Amendment.
NOW, THEREFORE, in consideration of the premises and of the
mutual covenants of the parties hereto, it is hereby agreed as
follows:
1.
Definitions and Interpretation .
1.1. In this
Agreement, the following words and expressions shall have the
following meanings:
“Affiliate”
shall mean,
with respect to any party, any Person which, directly or
indirectly, is controlled by, controls or is under common control
with such party. For
purposes of
this definition, the term “control” (including with
correlative meanings, the terms “controlled by” and
“under common control with”) shall mean, with respect
to any Person, the direct or indirect ownership of more than fifty
percent (50%) of the voting or income interest in such Person or
the possession otherwise, directly or indirectly, of the power to
direct the management or policies of such Person.
“Agreement
Products” shall mean (a) the two
products made of hylan B and called Hylaform® and
Hylaform® Plus, respectively, and (b) the one product made
with bacterial hyaluronan that has been cross-linked using the
hylan B cross-linking process and called Captique™; the
specifications of each of which are set forth on Exhibit A ,
for use in the correction of wrinkles and depressed scars. In
addition, upon mutual written agreement, the parties may include
additional products as “Agreement Products” by
attaching the specifications for such product(s) to Exhibit
A , which specifications shall including the initial Minimum
Price for such additional product(s). Upon attaching such
specifications, each additional product shall be deemed an
“Agreement Product” hereunder.
“Agreement Product
Specifications” shall mean the
specifications for the Agreement Products set forth in Exhibit
A , as such specifications may be modified or supplemented by
Genzyme from time to time in accordance with Product License
Approvals or to reflect any Improved Agreement
Product(s).
“Agreement
Year” shall mean the twelve (12)
month period commencing on ***
*** and each separate successive
twelve (12) month period thereafter.
“Binding
Forecast” shall mean that term as
defined in Section 7.3(a).
“Captique”
shall mean the
Agreement Product made with bacterial hyaluronan that has been
cross-linked using the hylan B cross-linking process and called
Captique™.
“Committee”
shall mean
that term as defined in Section 11.
“Contract
Quarter” shall mean, for sales of
Agreement Products, the period commencing on
***
and ending on
***
and each three (3) month period thereafter throughout the
term of this Agreement.
“Dermal Tissue
Augmentation Products” shall mean
biomaterial(s)
***
***
***
***
“Development
Costs” shall have the meaning set
forth in the Development Agreement and Amendment and, for the
avoidance of any doubt, shall include the fully loaded costs
incurred by either party in connection with maintaining FDA
Approvals, including, without limitation, any Phase IV
post-marketing clinical trials
***
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performed in
connection with any Agreement Product(s) or Improved Agreement
Products. For the purposes of this definition, “fully
loaded costs” shall mean (a) all direct costs of labor, raw
materials, supplies, services, fees (including external costs
incurred by third parties) and other resources consumed or used in
the conduct of the applicable activity, and (b) all indirect costs
of rent, utilities, insurance, facility and equipment depreciation,
administrative support and other overhead charges related to the
applicable activity. Indirect costs shall be allocated based
upon the portion of such costs directly attributable to the support
of the applicable activity. All cost determinations made
hereunder shall be made in accordance with generally accepted
accounting principles consistently applied.
“
Dollars” and “$” shall mean the
lawful currency of the United States of America.
“Effective
Date” shall mean
***
“EU
Countries” shall mean, collectively,
Austria, Belgium, Denmark, Finland, France, Germany, Greece,
Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain,
Sweden and the United Kingdom.
“European
Territory” shall mean, collectively,
the EU Countries, Switzerland, Norway, Liechtenstein and
Iceland.
“FDA”
shall mean the
U.S. Food and Drug Administration.
“FDA
Approval” shall mean, with respect
to an Agreement Product, receipt by Genzyme of an approval letter
from the FDA to promote, market, distribute and sell such Agreement
Product in the Territory.
“Fee
Payment Default” shall mean that term as
defined in Section 7.1(c).
“Formula
Price” shall mean an amount equal
to
***
***
***
***
“Hylaform”
shall mean the
Agreement Product made of hylan B and called
Hylaform®.
“Hylaform
Plus” shall mean the Agreement
Product made of hylan B and called Hylaform® Plus.
“Improved Agreement
Product(s)” shall mean (i) any
modification of an Agreement Product (that is made entirely from
hylan B) regarding the formulation of hylan B in such Agreement
Product, that is changes of concentration of the polymer or other
changes in the applicable Agreement Product Specifications for
such
***
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Agreement
Product, whether or not requiring new regulatory approval in the EU
Countries or in the United States, and (ii) any modifications or
changes related to the packaging of an Agreement Product, including
the syringe used, mode of application or dosage.
“Incremental
Royalties” shall mean that term as
defined in Section 8.2.
“Initial
Term” shall mean that term as
defined in Section 3.2.
“International
Agreement” means the Distribution
Agreement between Genzyme and Distributor, dated as of June 14,
1996, as amended from time to time, relating to the sale of
Agreement Products in the EU Countries, Switzerland, Norway,
Liechtenstein, Iceland, Australia, New Zealand, Canada, Israel,
Argentina, Mexico, Chile and Brazil.
“International
Territory” shall mean, collectively,
the EU Countries, Switzerland, Norway, Liechtenstein, Iceland,
Australia, New Zealand, Japan, Israel, Argentina, Brazil, Chile,
Mexico and Canada.
“Launch”
shall mean the
commencement by the Distributor of sales of an Agreement Product in
commercial quantities in the Territory for use in the
Territory.
“Minimum
Price” shall initially mean (a)
***
***
($
*** ) for each Treatment Syringe, (b)
***
***
($
*** ) for each Treatment Syringe, (c) with respect to
any Improved Agreement Product(s), the parties shall attempt in
good faith to agree in writing upon mutually acceptable minimum
pricing, and (d) with respect to any additional Agreement Products
added to this Agreement by mutual written consent of the parties,
the amount set forth on Exhibit A with respect to such
additional Agreement Product.
***
***
***
***
***
.
If the Distributor’s rights to distribute the Agreement
Products in the Territory become non-exclusive pursuant to Section
2.3, the then applicable Minimum Price payable (i) during the
***
Agreement Years immediately following such conversion to
non-exclusivity shall be adjusted
***
*** for each Treatment
Syringe, and (ii) during the
***
Agreement Years following such conversion to non-exclusivity shall
***
*** ($ *** ) for each
Treatment Syringe.
***
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“Net
Retail Sales ” shall mean, with
respect to sales of a Dermal Tissue Augmentation Product in the
Territory
“New
Products” shall mean any and all
Dermal Tissue Augmentation Products made of:
“Non-Binding
Forecast” shall mean that term as
defined in Section 7.3(a).
“Patents”
shall mean
Letters Patent or similar statutory rights relating to any
Agreement Products and any Improved Agreement Product(s) (including
any continuation-in-part, continuation or division thereof or
substitute thereof), and patent applications which are pending as
of the Effective Date, in each case as set forth in Exhibit
B , together with any supplementary or complementary protection
certificates therefor if and when such are granted.
“Person”
shall mean an
individual, a corporation, limited liability company, a
partnership, a trust, an unincorporated organization or a
government or any agency or political subdivision
thereof.
“Product
Guidelines ” shall mean the
product promotional guidelines jointly developed by Genzyme and the
Distributor related to the promotion, marketing and sale of the
Agreement Products and any Improved Agreement Product(s) in the
United States entitled, “Hylaform® (hylan B gel) Product
Family - Product Promotional Guidelines & Style Guide”
and any changes in writing thereto mutually agreed upon by the
Parties.
“Product License
Approvals” shall mean those
regulatory approvals required for the importation, promotion,
marketing and sale of the Agreement Products and any Improved
Agreement Product(s) in the United States (including any
reimbursement or pricing approvals).
“Region”
shall mean any
one of the following countries or groups of countries:
***
***
***
***
“Territory”
shall mean the
United States.
“Trademarks”
shall mean (a)
the registered trademark Hylaform® and the trademark
Captique™, the details of each of which are described in
Exhibit B , and
***
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(b) any other
trademarks, as may be agreed upon in writing from time to time by
the parties hereto for use by the Distributor in connection with
the promotion, marketing and sale of the Agreement Products and any
Improved Agreement Product(s) under this Agreement.
“Treatment
Syringe” shall mean a
ready-for-injection 0.9cc syringe of an Agreement
Product.
“United States
Consumer Price Index” shall mean the Consumer
Price Index, All Items, United States, as published by the Bureau
of Labor Statistics.
1.2. In this
Agreement, unless the context otherwise requires:
(a)
clause headings are inserted for convenience of reference only and
have no legal effect;
(b)
references to sections, exhibits and schedules are to be construed
as references to the sections of, and exhibits and schedules to,
this Agreement and references to this Agreement include its
exhibits and schedules;
(c)
references to (or to any specified provision of) this Agreement or
any other document shall be construed as references to this
Agreement, that provision or that document as in force for the time
being and as amended, varied, substituted, supplemented, restated
or novated in accordance with the terms thereof or, as the case may
be, with the agreement of the relevant parties and (where such
consent is, by the terms of this Agreement or the relevant
document, required to be obtained as a condition to such amendment
being permitted) the prior written consent of Genzyme;
(d)
words importing the plural shall include the singular and vice
versa;
(e)
references to a person shall be construed as including references
to an individual, firm, consortium, company, corporation,
unincorporated body of persons or any State or any agency thereof;
and
(f)
references to statutory provisions shall be construed as references
to those provisions as replaced, amended or re-enacted from time to
time.
2.
Appointment; Best Efforts; Exclusivity .
2.1.
Appointment .
(a)
Subject to the terms and conditions hereinafter set forth, Genzyme
hereby appoints the Distributor as its exclusive
***
(except to the extent set forth in Section 2.3) distributor
for the promotion, marketing, sale and distribution within the
Territory of the Agreement Products and any Improved Agreement
Product(s) supplied by
***
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Genzyme or an
Affiliate of Genzyme to the Distributor pursuant to this
Agreement. Such appointment does not include the right to
sublicense or appoint subdistributors except to an Affiliate of
Distributor without the approval of Genzyme (and only for such time
as such an Affiliate remains an Affiliate of
Distributor).
(b)
Except as specifically provided to the contrary herein, the
foregoing appointment shall not be construed, by implication or
otherwise, (i) to effect any sale of proprietary Genzyme
technology, (ii) to grant any license relating to
Genzyme’s proprietary methods of formulating, fabricating and
manufacturing the Agreement Products or any Improved Agreement
Product(s), or (iii) to grant the Distributor any rights in or to
any proprietary technology or patents or trademarks of
Genzyme.
2.2.
Acceptance of Obligations; Best Efforts . The
Distributor hereby accepts the appointment described in Section 2.1
and hereby agrees to use its best efforts at all times during the
term hereof to promote, market, sell and distribute the Agreement
Products and any Improved Agreement Product(s) in the
Territory. Distributor’s “best efforts” in
this Section 2.2 shall mean that Distributor shall use generally
the same channels and methods, exercise the same degree of effort
and diligence, and adhere to the same standards as Distributor and
its Affiliates would apply in distributing their own
actively-promoted pharmaceutical products, and shall be such as are
commercially reasonable.
2.3.
Conversion to Non-Exclusive Distributorship . In the
event that in any Agreement Year including and after the
*** Agreement Year (and so long
as (i) no force majeure condition of Distributor exists at such
time pursuant to Section 20, (ii) Genzyme has met its supply
obligations under Section 7.4 and (iii) Distributor is able to
lawfully sell any Agreement Products or any Improved Agreement
Product(s) in the Territory), the Distributor’s Net Retail
Sales of the Agreement Products and any Improved Agreement
Product(s) in the Territory in such Agreement Year comprise less
than
***
***
***
,
either Genzyme or the Distributor may elect upon
***
notice, but in any event not
later than ***
*** after the end of the
applicable Agreement Year, to convert the Distributor’s
distribution rights under this Agreement in the Territory from
exclusive to non-exclusive; provided , however , that
Distributor may cure, within
***
after receipt of any such notice from
Genzyme, a shortfall of Net Retail Sales with respect to the
Territory for an Agreement Year by paying to Genzyme within
***
after such Agreement Year an amount equal to
***
***
in such Agreement Year for such Territory;
further provided that at Genzyme’s election,
Genzyme may refuse to allow such cure if Distributor has taken
advantage of such cure provision in each of the two preceding
Agreement Years.
***
***
***
***
.
Upon conversion of Distributor’s rights to a non-exclusive
distribution arrangement in the
***
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Territory, Genzyme shall
have the right to distribute the Agreement Products and Improved
Agreement Products and/or engage another distributor for the
Territory. From and after the date of a conversion to a
non-exclusive distribution arrangement within the Territory, the
Distributor shall lose its rights hereunder to promote, market,
sell and distribute within the Territory any Improved Agreement
Product(s) commercialized on or after such date.
Notwithstanding the foregoing, the Distributor shall retain the
exclusive right to use all trademarks under which the Distributor
launched the Agreement Products or any Improved Agreement
Product(s) in the Territory.
3.
Term and Termination .
3.1.
Effective Date . This Agreement shall take effect as
of the Effective Date.
3.2.
Term .
(a)
Unless this Agreement is sooner terminated in accordance with the
provisions of this Agreement, the term of the appointment hereunder
for shall commence on the first day of the first Agreement Year and
shall end on the last day of the
***
Agreement Year (the “Initial Term”).
(b)
Unless this Agreement is sooner terminated in accordance with the
provisions of this Agreement, the appointment of the Distributor
hereunder as exclusive distributor of the Agreement Products shall
be renewable by the Distributor, at its option, upon written notice
to Genzyme received at least
***
prior to the end of the Initial Term, for
an additional consecutive term of
***
following the date of expiration of the
Initial Term, provided that the Distributor shall
only be entitled to exercise such renewal option if as of the date
of expiration of the Initial Term the Distributor is not in
material breach of any of its obligations under this
Agreement. Thereafter, the appointment of the Distributor as
exclusive distributor of the Agreement Products shall be renewable
upon the expiration of such additional
***
term, upon written notice to Genzyme received at
least ***
*** prior to
the end of such term for one additional consecutive renewal term of
***
*** years, provided that , as of the date of
expiration of the first renewal term, the Distributor is not in
material breach of any of its obligations under this
Agreement. For the avoidance of any doubt,
Distributor’s rights with respect to any Improved Agreement
Product(s) commercialized after the commencement of the
***
Agreement Year shall terminate upon the last day of the
***
Agreement Year. Subject to the terms
of this Agreement, Distributor shall have the right to continue to
sell the Agreement Products and any Improved Agreement Product(s)
it is then currently selling.
(c) In
the event that in any Agreement Year including and after the
*** Agreement Year (and so long as (i) no
force majeure condition of Distributor exists at such time pursuant
to Section 20, (ii) Genzyme has met its supply obligations under
Section 7.4, and (iii) Distributor is able to lawfully sell any
Agreement Product and/or any Improved Agreement Product(s) in the
Territory), in the event that the Distributor’s Net Retail
Sales of
***
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the Agreement Products and
any Improved Agreement Product(s) in the Territory in any Agreement
Year comprise less than
***
***
***
, the Distributor’s distribution rights (including, without
limitation, its right to use the Trademarks) under this Agreement
for the Agreement Products and any Improved Agreement Product(s) in
the Territory shall terminate upon
***
notice, but in any event not later than
***
***
; provided , however , that Distributor may cure a
shortfall of Net Retail Sales for an Agreement Year by paying to
Genzyme an amount equal to
***
***
; further
provided that , at Genzyme’s election, Genzyme
may refuse to allow such cure if Distributor has taken advantage of
such cure provision in each of the two preceding Agreement
Years. ***
***
***
***
Upon any such termination
of the Distributor’s distribution rights in the Territory,
the Distributor’s obligation to pay any royalties pursuant to
Sections 8.1 and 8.2 for any sales in the Territory after such
termination shall cease, but the Distributor shall remain obligated
to pay all such royalties for sales in the Territory accrued prior
to such termination.
(d) In
the event the Distributor has not commenced a Launch of Captique by
***
*** , the Distributor’s distribution
rights (including, without limitation, its right to use the
Captique Trademark) under this Agreement for Captique in the
Territory shall terminate upon
***
notice at the election of Genzyme.
3.3.
Inventory .
(a)
Upon termination of this Agreement for any reason, Genzyme shall
have the right (but not the obligation) to repurchase all or part
of the inventory of the Agreement Products and any Improved
Agreement Product(s) held by the Distributor or its
Affiliates.
(b) The
price for inventory to be repurchased by Genzyme pursuant to
Section 3.3(a) above shall be the landed cost thereof actually paid
by the Distributor to Genzyme. With respect to any quantities
not repurchased by Genzyme, the Distributor shall have the right to
sell such inventory of the Agreement Products and any Improved
Agreement Product(s), in its usual and customary manner, in the
ordinary course of business, for a period of
***
following termination of this Agreement and
notwithstanding such termination the terms and conditions of this
Agreement shall apply to such sales.
3.4.
Insolvency . This Agreement may be immediately
terminated by either party, upon giving written notice to the other
party, in the event that the other party shall become insolvent or
be declared bankrupt by a court of competent jurisdiction or shall
be the subject of any reorganization (other than a corporate
reorganization effected in the ordinary course of business and not
arising out of any insolvency) or winding up, receivership or
dissolution,
***
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bankruptcy or liquidation
proceeding, or any proceeding or action similar to one or more of
the above, in which case termination shall be effective upon such
written notice. The failure of either party to give notice of
termination upon obtaining knowledge of any such event shall not be
interpreted as a waiver of such party’s rights under this
Section 3.4, and such party reserves the right to exercise any such
rights at any time after the occurrence of any such
event.
3.5.
Breach . This Agreement may be terminated by either
party if the other party shall breach any of its payment
obligations hereunder (in the event of a Fee Payment Default,
Genzyme shall have the right to terminate only the
Distributor’s rights with respect to Captique) or if either
party shall commit a material breach of any of its warranties,
covenants, conditions, obligations or agreements contained herein,
provided that such breach shall continue for a period
of
***
***
after written notice thereof and provided
further that such termination shall be immediately effective
upon further written notice to that effect to the breaching party
after its failure to cure such breach within such applicable notice
period.
3.6.
Certain Rights Upon Termination . Upon termination of
this Agreement for any reason whatsoever, Genzyme shall have the
following rights:
(a)
Genzyme shall have the unrestricted right to review, access, use
and permit others to review, access and use, either directly or by
cross-reference or incorporation or otherwise, all information,
data, investigations, preclinical and clinical protocols, marketing
information disseminated by Distributor publicly to customers and
patients and all information required to be provided to Genzyme by
law, information relating to laboratory, animal and human studies,
and related regulatory approvals pertaining to the Agreement
Products or any Improved Agreement Product(s) (the
“Information”) which are possessed or controlled by the
Distributor or any of its Affiliates, or to which the Distributor
or any of its Affiliates has a right to review, access or
use. The Distributor unconditionally agrees promptly to take
any action and to execute and deliver to Genzyme any documents or
instruments reasonably requested by Genzyme to permit Genzyme to
make full use of such unrestricted right.
(b)
Further, Genzyme shall have exclusive ownership rights to the
Trademarks and to all other product specific logos, slogans and
other intangibles used by the Distributor solely in association
with the independent sale of the Agreement Products and any
Improved Agreement Product(s) (including any and all good will
associated with the Agreement Products and any Improved Agreement
Product(s) and all registrations relating thereto) possessed or
controlled by the Distributor or any of its Affiliates, and the
Distributor unconditionally agrees, subject to the provisions of
Section 3.3(b), (i) immediately upon termination to cease using the
Trademarks and any such logos, slogans, and marketing rights of
Genzyme or any imitations thereof and (ii) immediately to execute
and deliver to Genzyme any documents or instruments reasonably
requested by Genzyme to give full effect to the provisions of this
Section 3.6.
***
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(c) In
addition, the Distributor unconditionally agrees, subject to the
provisions of Section 3.3(b), that it shall, upon the request of
Genzyme, immediately inform all relevant regulatory authorities
that the Distributor is no longer a distributor of the Agreement
Products or the Improved Agreement Product(s) and shall take all
action and execute and deliver all documents and instruments
necessary in order to transfer to the fullest extent permitted
under applicable law all registrations and Product License
Approvals, or applications therefor, for the Agreement Products or
any Improved Agreement Product(s) to Genzyme or any Person
nominated by Genzyme.
3.7.
Effects of Termination .
(a)
Upon termination of this Agreement for any reason, the Distributor
shall immediately discontinue making any representations regarding
its status as a distributor for Genzyme and shall immediately cease
conducting any activities with respect to the marketing, promotion,
sale or distribution of the Agreement Products and any Improved
Agreement Product(s), provided , however , that the
Distributor shall be permitted to sell inventory not repurchased by
Genzyme in accordance with Section 3.3.
(b)
Termination of this Agreement shall not affect obligations of
either party that may have accrued prior to the effective date of
termination. Subject to Clause 3.8 below, termination of this
Agreement shall be in addition to, and shall not be exclusive of or
prejudicial to, any other grounds for termination or rights or
remedies at law or in equity which either party may have on account
of any default of the other party.
3.8.
Waiver . The Distributor hereby waives, to the extent
it is able to do so under the laws of the United States and other
applicable law, any statutory rights it may have or acquire in
respect of the termination of the relationship established hereby
pursuant to the terms hereof, and agrees that the rights available
to it hereunder in the event of such termination are adequate and
reflect the agreement of the parties. The Distributor shall
not have any right to claim any indemnity for goodwill or lost
profits or any damages arising from the rightful termination of
this Agreement in accordance with the terms hereof.
4.
Payments . All payments hereunder shall be made
in Dollars. Payments to Genzyme shall be wired to an account
designated by Genzyme and the costs of any such remittance shall be
borne by the Distributor.
5.
Withholding . All payments to be made by the Distributor
under this Agreement shall be made in full, free and clear of and
without any deduction of or withholding for or on account of any
taxes levied in any country of the Territory or elsewhere;
provided that if the Distributor shall be required by law to
make any deduction or withholding from any payment to Genzyme
then:
(a) the
Distributor shall ensure that such deduction or withholding does
not exceed the minimum legal liability therefor; and
11
(b) not
later than *** days
before each deduction or withholding of any taxes, the Distributor
shall forward to Genzyme such documentary evidence as may be
required by Genzyme in respect of the proposed deduction,
withholding or payment; and
(c)
prior to any deduction or withholding the parties shall attempt in
good faith to agree upon revised mutually acceptable pricing and/or
payment terms.
6.
Trademarks; Agreement Product Marking; Promotional
Information .
6.1.
Trademarks . Subject to the provisions of Section 3.6,
Genzyme hereby licenses to the Distributor the right to use, and
hereby requires solely in association with the independent sale by
the Distributor of the Agreement Products and any Improved
Agreement Product(s) the use of, the Trademarks in the Territory
during the term of this Agreement. The Distributor agrees
that any and all goodwill developed in the Trademarks used by
Distributor hereunder shall inure to and be owned by Genzyme.
The Distributor warrants that it shall not use any of the
Trademarks at any time outside the Territory or use any of the
Trademarks for any products other than the Agreement Products and
any Improved Agreement Product(s) within the Territory. The
Distributor shall not use a trademark or other mark (other than a
Trademark) in connection with its distribution of the Agreement
Products and any Improved Agreement Product(s) unless and until it
has been agreed upon in writing by each of the parties and become a
Trademark as defined herein. Genzyme shall prosecute,
maintain and defend the Trademarks throughout the Term of this
Agreement in the Territory. The parties shall execute a short
form Trademark assignment agreement to the extent that it is
necessary to record the Trademark license under this Section
6.1.
6.2.
Termination of Right to Use Trademarks . Subject to
the sell-out right of Section 3.3(b) and except as otherwise
provided in Section 3.6, upon termination of this Agreement, the
license to use the Trademarks in the Territory shall terminate, and
the Distributor unconditionally agrees promptly to take all
necessary action and execute and deliver to Genzyme all necessary
documents and instruments to remove the Distributor as a registered
user and/or a recorded licensee of the Trademarks and to confirm
that the goodwill in the Trademarks shall inure to the benefit of
Genzyme. In the event that the Distributor fails promptly
upon written request by Genzyme to comply with any of its
agreements in the preceding sentence of this Section 6.2, the
Distributor hereby irrevocably consents to Genzyme’s taking
any action necessary to give effect to such agreements.
6.3.
Notice . Each party hereto agrees promptly to notify
the other in writing of any infringements or imitations of the
Trademarks by third parties which may come to its
attention.
6.4.
Labelling; Promotional Materials; Approved Use of Agreement
Products .
(a)
Genzyme shall provide the Distributor with copies of labelling
masters, packaging, instructions and specifications relating to the
Agreement Products and any Improved Agreement Product(s) prior to
their use. The Distributor shall not change or
alter
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12
the packaging or labelling
identified in the Product License Approvals without the prior
written approval of Genzyme.
(b)
The Distributor shall provide Genzyme with copies of all marketing
and promotional material relating to the Agreement Products and any
Improved Agreement Product(s) prior to their use.
All marketing and promotional material shall be
consistent with the Product Guidelines and the relevant Product
License Approvals, and deemed acceptable in such case. Any
marketing and promotional material outside the scope of the Product
Guidelines shall require the written approval of Genzyme prior to
their use.
(c) The
Distributor agrees that its promotion, marketing, sale and
distribution of the Agreement Products and any Improved Agreement
Product(s) in the Territory, and the promotional materials and
labelling used in connection therewith, shall be strictly in
accordance with the approved use of the Agreement Products and any
Improved Agreement Product(s) as specified in the Product License
Approvals and as further provided in this Agreement.
6.5.
Legend . Subject to applicable laws and regulations in
the Territory, all relevant packaging and promotional material for
the Agreement Products and any Improved Agreement Product(s) used
or sold by the Distributor shall contain (i) all applicable
markings needed to keep the Trademarks enforceable throughout the
Territory as reasonably specified by Genzyme to the Distributor and
(ii) a legend which shall be displayed in a reasonably conspicuous
manner on all packaging of such Agreement Products and any Improved
Agreement Product(s) containing the corporate identification logo
of Genzyme and indicating that such product has been developed and
manufactured by Genzyme Corporation, and its affiliates, 500
Kendall Street, Cambridge, Massachusetts 02142 U.S.A.
6.6.
Promotional Support . Genzyme and the Distributor
shall provide to each other on an ongoing basis and without charge
(to the extent not prevented by law or contract from doing so) all
medical information relating to the Agreement Products and any
Improved Agreement Product(s) (including summary data from studies,
clinical trials and the like as well as information regarding
adverse events associated with the use of the Agreement Products),
the proceedings of all symposia on the Agreement Products and any
Improved Agreement Product(s) and all promotional information that
is available to such
