1
IMPORT SERVICES AGREEMENT
by and among
COLLAGEN CORPORATION
COLLAGEN KK
and
LEDERLE (JAPAN), LTD.
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Application for an order granting confidential treatment pursuant to
Rule 24b-2 of the Securities Exchange Act of 1934 has been or will be timely
made. Confidential portions of this document have been redacted and marked with
an [***] and have been filed with the Securities and Exchange Commission
separately with such application.
IMPORT SERVICES AGREEMENT
This Agreement is made as of May 18, 1998, by and among COLLAGEN
CORPORATION, a California corporation with offices at ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇
▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Collagen"), COLLAGEN KK, a Japanese corporation with a
registered address at Kita-Aoyama 1-2-3, Minato-ku, Tokyo ("CKK"), and LEDERLE
(JAPAN), LTD., a Japanese joint stock company with offices, at ▇▇-▇, ▇▇▇▇▇▇▇▇,
▇.-▇▇▇▇▇, ▇▇▇▇-▇▇, ▇▇▇▇▇, ▇▇▇▇▇ ("Lederle").
WHEREAS, Collagen and Lederle entered into a Distribution Agreement dated June
26, 1985 and renewals of the Distribution Agreement most recently dated July 1,
1997 (the "Current Distribution Agreement") pursuant to which Collagen granted
Lederle the exclusive distribution rights for the Products (as defined below)
in the Territory (as defined below); and
WHEREAS, the Current Distribution Agreement will expire on June 30, 1998; and
WHEREAS, Collagen and Lederle have agreed that responsibility for marketing and
sales of the Products should be assumed by CKK, a subsidiary of Collagen
International, Inc. which will be actively supported and assisted by Lederle;
NOW THEREFORE, in consideration of the mutual promises contained herein, the
parties hereto agree as follows:
1. DEFINITIONS
As used in this Agreement:
(a) "Products" shall mean Zyderm(R) and Zyplast(R) Collagen
Implants as sold by Collagen in the United States and future
versions of Zyderm(R) and Zyplast(R) Collagen Implants which are
developed and marketed by Collagen during the term of this
Agreement for use in skin contour correction and dermal
augmentation using needle implantation.
(b) "Territory" shall mean Japan.
(c) Best Efforts" shall mean a party's reasonable business efforts
consistent with its overall business objectives and commensurate
with products of like nature, volume and market potential.
(d) "Product Approvals" shall mean all approvals (▇▇▇▇▇▇) granted by
the Japanese Ministry of Health and Welfare for or in connection
with the importation and/or distribution of any Products to
Japan, including but not limited to the following:
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Approval No. Subject Product Date of Approval Date of Application
------------ --------------- ---------------- -------------------
(62B)1096 Zyderm I November 6 ,1987 February 5, 1987
Test Implant
(62B)1100 Zyderm II November 6, 1987 July 3, 1987
(03B)0016 Zyplast January 11, 1991 April 17, 1990
(e) "First Year" shall mean the initial period of twelve (12)
months from the date hereof, and the terms "Second Year" and
"Third Year" shall mean the successive periods of twelve (12)
months thereafter following.
2. APPOINTMENT OF LEDERLE AS IMPORTER AND DISTRIBUTION AGENT
(a) APPOINTMENT: Subject to the terms and conditions of this
Agreement, Collagen hereby appoints Lederle as exclusive
importer, and CKK appoints Lederle as its exclusive distribution
agent of the Products in the Territory. Lederle accepts these
appointments.
(b) INDEPENDENT CONTRACTORS: It is understood that Lederle of the
first part and Collagen and CKK of the second part are
respectively independent contractors and are engaged in the
operation of their own businesses. Neither party has any
authority to enter into any contracts or assume any obligations
for the other party or make any warranties or representations on
behalf of the other party.
3. OBLIGATIONS OF LEDERLE
(a) IMPORTATION OF PRODUCTS, ETC.: Lederle agrees to use its Best
Efforts to investigate, maintain government approval for and to
import the Products, at its own expense, into the Territory,
until such time as all Product Approvals have been transferred
to CKK, and upon CKK's instructions and on CKK's behalf to
distribute the Products within the territory, exercising the
same diligence and adhering to the same standards which it
employs with respect to its own pharmaceutical products. In
particular, Lederle shall at its own expense:
(i) Until such time as all Product Approvals have been
transferred to CKK, exercise due diligence to obtain and
maintain government approvals necessary hereunder to
import the Products into the Territory and to sell the
Products to CKK, and to diligently proceed to secure, as
may be required from time to time, customs clearances
and currency authorizations and any permits necessary
therefore in the Territory. Lederle shall keep Collagen
and CKK fully informed of the status of the Product
Approvals and of any changes in the regulatory
requirements for the Territory.
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(ii) Submit to Collagen regular monthly offtake forecasts for
the Products in the Territory and to update Collagen on
a timely basis with information concerning competitive
products and procedures.
(iii) Sell the Products only to CKK and, upon CKK's
instructions and on CKK's behalf, distribute the
Products for use only by physicians for treatment of
patients in the Territory in compliance with local laws
and regulations and good commercial practice and for
uses and applications approved by Collagen for the
Products.
(iv) Should the requirements of the Japanese Ministry of
Health and Welfare or any other relevant governmental
body related to or affecting the Products change, the
parties agree to review these procedures to ensure
continued conformity.
(b) QUALITY CONTROL: As importer of the Products, Lederle shall be
responsible for performing all necessary quality control
required under Japanese laws and practice.
(c) MARKETING SUPPORT and Advice: To enable CKK to market and sell
the Products effectively and efficiently, Lederle shall make
available all information and material in its possession or
control pertaining to the Products, the relevant market,
customers and groups of customers, and shall ensure that its
sales and marketing staff and any other personnel with knowledge
or experience in marketing the Products are available on a
priority basis to assist CKK on a priority basis as and when
required by CKK. In addition, Lederle shall provide CKK
management with such information, advice and counsel as CKK's
management may request.
(d) REPORTS: Lederle shall at its expense submit regular monthly
reports to CKK setting forth sales of the Products effected by
Lederle on CKK's behalf in the Territory for the previous month
(including prices, unit sales and other information as may be
reasonably requested by Collagen from time to time).
(e) PROTOCOLS: Lederle undertakes to continue to comply with the
following listed protocols previously provided to Lederle and
attached hereto as Exhibit B:
(i) International Marketing Recall Guideline
(ii) International Marketing Shipments to Customers Guideline
(iii) International Marketing Receiving of Collagen Products
Guideline
(iv) International Marketing Report of Technical and Medical
Complaints Guidelines
(f) PERFORMANCE OF OBLIGATIONS: Lederle understands, acknowledges,
and agrees that the continued maintenance of an image of
excellence and high level of ethical marketing of the Products
is essential to the continued success of both parties
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hereto. Accordingly, Lederle hereby agrees that it shall, at all
times: (i) conduct business in a manner that reflects favorably
at all times on the Products and the good name, goodwill, and
reputation of Collagen; (ii) avoid deceptive, misleading or
unethical practices that are or might be detrimental to
Collagen, the Products, or the public, including without
limitation the making or offering of any payment to any
government official for the purpose of influencing any act or
decision of such official in furtherance of this Agreement;
(iii) make no false or misleading representations, either
orally or in any written material, with regard to Collagen or
the Products; (iv) not publish or employ, or cooperate in the
publication or employment of, any misleading or deceptive
advertising material with regard to Collagen or the Products;
(v) make no representations, warranties or guarantees to
customers or to the trade with respect to the specifications,
indications, capabilities, or features of the Products that are
inconsistent with the literature distributed by Collagen and
(vi) not enter into any contract or engage in any practice
detrimental to the interests of Collagen in the Products.
Violation of any of the provisions in the foregoing subsection
3(e) and in this subsection 3(f) shall constitute a material
breach of this Agreement.
4. OBLIGATIONS OF COLLAGEN
(a) REQUIREMENTS OF LEDERLE: Collagen shall for as long as Lederle
acts as importer hereunder supply Lederle's requirements for the
Products in the Territory based on CKK's requirements and
consistent with Collagen's commitments to its other customers.
CKK's requirements for the Products shall be subject to review
and consent by Lederle, which consent shall not be unreasonably
withheld.
(b) IMPORTATION SUPPORT: To assist Lederle in importing the Products
in the Territory, Collagen shall provide to Lederle, free of
charge, certificates of analysis concerning the Products
purchased by Lederle, certificates of free sale, and any other
documents which Lederle may require for registration purposes,
at Lederle's request.
(c) TRADEMARK LICENSE: Collagen hereby grants to Lederle the
non-exclusive right and license to use Collagen's trademarks
Zyderm(R) and Zyplast(R) for the Products in the Territory for
the term of this Agreement, but only in connection with the
importation of the Products purchased from Collagen in the
Territory and sale thereof to CKK. Lederle shall be required to
use Collagen's trademark with respect to all sales of the
Products. Such trademark license shall continue in effect for
the Territory while Lederle retains its importation rights in
the Territory under this Agreement. All right, title and
interest to Collagen's trademark (except the right to use such
trademark set forth herein) shall remain with Collagen. Lederle
shall not have the right to use Collagen's name in any
advertising or promotion or otherwise without Collagen's prior
written consent. Upon Lederle's request Collagen shall at its
expense file trademark registrations in the Territory.
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5. TERMS AND CONDITIONS OF SALE
(a) TERMS OF ORDERS: All purchases of the Products by Lederle from
Collagen during the term of this Agreement shall be subject to
the terms and conditions of this Agreement and to Collagen's
Terms and Conditions of Sale as Collagen may establish from time
to time, provided that in the event of any conflict between the
terms of this Agreement and the Terms and Conditions of Sale of
Collagen, this Agreement shall be controlling. Any printed or
standard terms and conditions contained in Lederle's purchase
order form shall be disregarded. All purchase orders submitted
by Lederle to Collagen shall be subject to acceptance by
Collagen at its offices at Palo Alto, California, which
acceptance shall not be unreasonably withheld.
(b) PACKAGING: All quantities of the Products shall be in the form
of U.S. packaging with Japanese labeling and Japanese pack
inserts, to be shrink wrapped in Fremont, California. The
Product will be shipped to Japan in this fashion and resold by
Lederle who will not break the shrink wrapping.
(c) QUALITY CONTROL: Lederle shall check the quality of the Products
in accordance with Collagen's instructions as may be given from
time to time and shall at all times comply with applicable
governmental regulations relating to the Products including but
not limited to quality and safety regulations.
(d) PRICE AND PAYMENT: Collagen shall sell the Products to Lederle
for the prices in accordance with Exhibit A hereto. All taxes,
fees, duties and other charges with respect to the sale by
Collagen to Lederle of the Products (excluding income taxes,
franchise taxes and taxes based on income) shall be paid by
Lederle or, if paid by Collagen or CKK be forthwith reimbursed
by Lederle. All payments shall be made within one hundred and
twenty (120) days from the date of shipment of the Products to
Lederle. If Lederle fails to make any payment to Collagen when
due, except where CKK is in default of any payment pursuant to
Section 6 (d), (i) Collagen may terminate this Agreement upon
giving thirty (30) days' written notice if within that period of
thirty (30) days Lederle continues in its failure to make
payment to Collagen; and/or (ii) Collagen may, without affecting
its rights under this Agreement, cancel or delay any future
shipments of the Products to Lederle. Collagen will in each case
invoice Lederle in Japanese yen at yen/dollar conversion rates
fixed for the half-year periods commencing on January 1 and July
1, respectively which will be communicated to Lederle. All
payments to Collagen pursuant to this Agreement shall be made in
Japanese currency.
(e) WARRANTY: Collagen warrants that the Products sold to Lederle
will at all times comply with the requirements of and
regulations adopted pursuant to the U.S. Federal Food Drug and
Cosmetic Act.
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Collagen further represents and warrants and hereby agrees to
hold Lederle harmless from any and all liability, causes of
action, damages and/or judgments, including but not limited to
attorneys' fees, costs and expenses for any defect which may
arise from or due to Collagen's actions in not manufacturing the
Products for Lederle in accordance with applicable US Food and
Drug Administration ("FDA") rules and regulations and/or in
accordance with the IDE/PMA filed and amended by Collagen with
respect to the Products which have been approved by the FDA.
Collagen will provide, when requested by Lederle, certification
that to the best of its knowledge it is in compliance with U.S.
laws, statutes, rules, regulations and relevant orders relating
to the manufacture, use, distribution and sale of the Products.
If Lederle finds any deficiency in quantity and/or any defect in
quality of the Products delivered hereunder, Lederle shall
promptly give Collagen written notice of such deficiency or
defect, and Collagen, upon receiving such notice shall discuss
the deficiency or defect with Lederle and will work with Lederle
to insure Collagen's obligations under this Agreement with
regard to quantity and quality of supply are being met. Lederle
shall not be obligated to pay for Products with any claimed
deficiencies or defects until such claims are resolved. In the
event Collagen agrees that such defect in quality and/or
quantity are its responsibility, Collagen shall promptly and
without charge to Lederle make up for such deficiency and/or
replace such defective Products with Products meeting
specifications for Products. Collagen shall bear the costs of
return of such defective Products to Collagen. EXCEPT AS SET
FORTH ABOVE, COLLAGEN MAKES NO WARRANTIES, EXPRESS OR IMPLIED,
WITH RESPECT TO THE PRODUCTS, INCLUDING WITHOUT LIMITATION ANY
WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE.
(f) Collagen will continue to furnish from time to time samples for
testing as may be requested by the Japanese authorities free of
charge.
6. DISTRIBUTION OF PRODUCTS
(a) Lederle shall at its own risk and expense warehouse Products
imported in its own name or that of CKK hereunder, and shall
upon CKK's instruction and in CKK's name distribute such
Products to customers. Payments made by customers shall be
remitted directly to an account or accounts to be designated by
CKK.
(b) Lederle shall maintain complete and accurate records including
full particulars of each shipment and shall on or before the
fifteenth (15th) day of each month or at such other times as CKK
may request furnish CKK with fully particularized reports of all
shipments effected during the previous calendar month.
(c) As full consideration for Lederle's importation and distribution
of Products during the First Year, CKK shall pay to Lederle a
sum corresponding to the quantities of Products actually shipped
to customers during the First Year and calculated at the prices
set forth in subsection (d) of Section 5 ("Terms and Conditions
of Sale")
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hereof to which shall be added a margin of [***]; provided
that, for all Products shipped to customers on a complimentary
basis during the First Year, Lederle shall be reimbursed in an
amount equivalent to the price paid by Lederle to Collagen to
which shall be added a handling charge of five per cent (5%).
(d) Payments by CKK to Lederle shall be made within one hundred and
twenty (120) days of the end of the calendar month for the
Products sold during that calendar month. If CKK fails to make
any payment to Lederle when due, Lederle may terminate this
Agreement upon giving thirty (30) days' written notice, if
within that period of thirty (30) days CKK continues in its
failure to make payment due to Lederle, and/or without affecting
its rights under this agreement or incurring any liability to
Collagen and/or CKK, cancel or delay any further orders of the
Products to Collagen. All payments to Lederle by CKK pursuant to
this Agreement shall be made in Japanese currency.
(e) Title in any Products distributed by Lederle pursuant to this
Section 6 shall remain with Lederle until such goods have been
delivered to a customer, at which moment title shall be deemed
to have passed momentarily to CKK and immediately thereafter to
such customer. Lederle shall assume, and shall fully insure
against, all risks (including force majeure) in relation to
Products from the time of shipment by Collagen until such time
as risk passes to CKK and the respective customer.
(f) Lederle shall strictly observe all relevant rules and
regulations and adhere to the highest standards of professional
practice in the U.S. and Japan in relation to its warehousing
management of the Products and all related record-keeping in
accordance with Collagen policies.
(g) CKK shall immediately notify Lederle of any and all incidences
of side effects or adverse reactions with respect to Products
which come to its attention from customers in the Territory.
Collagen shall notify Lederle of any and all incidences of side
effects or adverse reactions which the U.S. Food and Drugs
Administration (FDA) requires Collagen to communicate to its
distributors or which Collagen is required to report to the FDA.
7. ASSIGNMENT OF APPROVALS
(a) Lederle shall transfer and assign any and all Product Approvals
to CKK and exercise its Best Efforts to cooperate with CKK, and
Lederle and CKK shall each exercise their best efforts so that
all Product Approvals are registered in favor of CKK on or
before June 30, 1999 (the "Assignment Target Date").
(b) Without limitation to the generality of the foregoing, Lederle
shall in particular:
(i) Transfer and deliver to CKK any and all documents (including
without limitation all supporting documentation and material
clinical reports and other
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records) submitted or supplied to the Ministry of Health and
Welfare (MHW), and any correspondence or other documents
exchanged with or received from MHW, in connection with any
Product Approvals or applications therefor, whether pursuant to
Art. 14 of the Pharmaceutical Affairs Law, Art. 21(6) of the
Implementing Regulations to the Pharmaceutical Affairs Law, or
otherwise.
(ii) Execute a form of assignment or assignment contract in a
form acceptable to CKK and to MHW for purposes of effecting the
transfer and assignment of the Product Approvals to CKK, and
assist in the filing and further prosecution of the application
for transfer of product approvals, including if requested
liaison with MHW on CKK's behalf. Following the filing of the
application for transfer of the application for transfer of
product approvals, CKK shall contact MHW once every month to
ascertain whether or not MHW has issued corresponding permits to
add medical devices as products to be imported (the "Permits").
CKK shall thereupon take delivery of the Permits within ten (10)
business days.
(c) Lederle shall execute all relevant documents, do any and all
things, take all necessary or appropriate steps and provide any
advice or support required or requested by CKK to ensure that
all Product Approvals are validly assigned to and assumed by CKK
by or before the Assignment Target Date. Collagen and Lederle
shall jointly ensure that Lederle will have sufficient stocks of
all Products to supply CKK's requirements until CKK is in a
position to import stocks in its own name, any excess inventory
of the Products to be purchased by CKK in the manner stipulated
in Section 7(e) hereunder.
(d) CKK will as soon as practicable establish suitable facilities to
enable it to be licensed by MHW as importer of the Products, and
will notify Lederle at an early stage of the date when, it
expects such facilities to have been established. Upon receipt
of CKK's notification, Lederle shall - without prejudice to any
other obligations hereunder - make best efforts to ensure that
the Product Approvals are transferred to CKK with the utmost
expedition.
(e) Following the assignment of Product Approvals to CKK, Lederle
shall cease all further importation and sale of Products and
shall promptly sell to CKK, and CKK shall purchase from Lederle,
all Products then in Lederle's inventory considered by CKK's
Quality Assurance Department to be in good condition for sale.
If any Products are considered not to be in good condition,
Lederle may request that CKK re-confirm the quality of such
Products in the presence of Lederle representatives. The price
for any Products purchased by CKK shall be the price Lederle
paid Collagen for the Products to which shall be added actual
costs incurred by Lederle in connection with the customs
clearance, transportation and landing, transitory warehousing
and insurance of such Products by independent third-party
contractors, as well as Consumption Tax at the then applicable
rate. For the avoidance of doubt, any additional cost and
expense to
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relabel or otherwise modify the Products sold to CKK shall be
for CKK's account.
8. ASSIGNMENT CONSIDERATION
(a) Within thirty (30) days of completion of the assignment of all
Product Approvals and receipt by CKK of Permits corresponding
thereto, Collagen shall pay to Lederle the sum of [***] as
consideration for the assignment of the Product Approvals
(hereinafter "Assignment Consideration"). Without prejudice to
any other remedies Collagen and CKK may have, no Assignment
Consideration shall be payable in the event that any Product
Approvals have lapsed or otherwise become incapable of being
assigned to CKK.
(b) In the event that Permits confirming CKK's ownership of all of
the Product Approvals (hereinafter collectively "Certificates")
have not been received by CKK by the Assignment Target Date, the
amount of the Assignment Consideration shall be successively
reduced by [***] of the original amount for the first, second or
third month or fraction thereof elapsing between July 1, 1999
and the first business day on which assignment of the Product
Approvals to CKK shall have been completed and CKK shall have
received the last of the Certificates, and shall likewise be
reduced by [***] for the fourth, fifth and sixth month or
fraction thereof thus elapsing.
(c) The provisions of the foregoing subsection (b) of this Section 8
shall not apply in the event that, Lederle having carried out
and fulfilled all of its obligations under Section 7 and Section
3 hereof, the transfer of the Product Approvals to CKK and
registration of the Product Approvals in CKK's name is delayed
due to:
(i) CKK's failure to take all reasonable steps to secure a
license under the Pharmaceutical Affairs Law enabling it
to act as importer of the Products no later than ninety
(90) days prior to the Assignment Target Date; or
(ii) Suspension or review of any Product Approvals by MHW,
provided that Lederle shall have notified CKK and
Collagen of the commencement of any such suspension or
review, or of any fact or development liable to occasion
such suspension or review by MHW, within five (5)
business days from the earliest date on which Lederle
became or could with reasonable diligence have become
aware thereof.
9. ONGOING SUPPORT AND DISTRIBUTION
(a) Following the transfer of the Product Approvals to CKK, Lederle
shall to the extent required by CKK continue to warehouse and
distribute Products on CKK's
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behalf in accordance with the provisions of Section 6
("Distribution of Products") hereof.
(b) Lederle shall at all times closely cooperate with CKK and use
its good offices generally to assist and support CKK's marketing
of the Products and to ensure that the transfer of Product
distribution to CKK is adequately explained to and accepted in
the market. Any statements etc. to be addressed to customers,
government entities and other affected parties shall without
exception be submitted to CKK for approval prior to circulation.
(c) As full and exclusive consideration for Lederle's distribution
of Products imported by Lederle or CKK and shipped to customers
pursuant to this ▇▇▇▇▇▇▇ ▇, ▇▇▇ shall pay the following amounts
as commission to Lederle:
(i) FOR ALL PRODUCTS (IF ANY) SHIPPED TO CUSTOMERS DURING THE
FIRST YEAR: an amount to be calculated according to subsection
(c) of Section 6 ("Distribution of Products") hereof.
(ii) FOR ALL PRODUCTS SHIPPED TO CUSTOMERS DURING THE SECOND
YEAR: an amount equivalent to [***] of CKK's net selling price
for such Products.
(iii) FOR ALL PRODUCTS SHIPPED TO CUSTOMERS DURING THE THIRD
YEAR: an amount equivalent to [***] of CKK's net selling price
for such Products.
Lederle shall be entitled at its own cost and expense to have an
internationally recognized firm of accountants audit CKK's books of
account and other records to the extent required to confirm CKK's net
selling price for Products.
(d) Lederle accepts and agrees that the payments stipulated in the foregoing
subsection (c) fully compensate it for the value of any goodwill,
customer information, marketing data made or to be made available to
CKK, any services rendered, costs incurred, personnel transferred, and
any rights Lederle may have acquired in connection with its importation
and sales of Products.
(e) In the event that the Product Approvals shall not have been transferred
to CKK and registered in CKK's name on or before the Assignment Target
Date, Lederle shall continue to import the Products in such quantities
and for such period as CKK may consider necessary. Upon shipment of such
Products to customers, Lederle shall invoice CKK for the yen equivalent
of the purchase price of such Products as set forth in Exhibit A hereof,
to which shall be added a commission in an amount equivalent to the
commission to which Lederle would have been entitled under subsection
(c) above had the Product Approvals been transferred; provided that
Lederle shall not be entitled to any other or further consideration,
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reimbursement or other payment in this case. Payments shall be made in
accordance with the payment terms set forth in subsection (d) of Section
6 ("Distribution of Products") hereof.
10. SECONDMENT AND TRANSFER OF KEY PERSONNEL
(a) At CKK's request, Lederle will exercise its Best Efforts to
second suitable Lederle personnel (up to a total of eight (8)
individuals) with knowledge of the Products to CKK.
(b) Lederle shall afford Collagen and CKK adequate opportunities to
interview and select appropriate individuals amongst Lederle's
staff. CKK's initial list of secondment request shall be
delivered to Lederle no later than May 25, 1998 for an effective
secondment as of July 1, 1998. Thereafter, CKK may from time to
time request further secondments as required until December 31,
1998.
(c) Upon receipt of CKK's list, Lederle will, subject to such
individuals' consent, second the individuals named therein to
CKK. Salaries, normal retirement benefits required to be paid
under Lederle's general staff rules, and employer's social
insurance (shakai hoken) contributions (hereinafter collectively
"Staff Expenses") as well as existing allowances incurred by
Lederle during and in respect of the period of secondment shall
be reimbursed by CKK, provided that CKK shall be under no
obligation to reimburse Lederle in respect of any increases in
Staff Expenses other than those that would have occurred in the
ordinary course of Lederle's operations had the individual not
been seconded. Lederle shall invoice CKK by the fifteenth day of
each calendar month for Staff Expenses and allowances paid
during the preceding calendar month. CKK shall pay the invoiced
amounts within fifteen days of receipt of Lederle's invoice by
remittance to an account with a bank in Japan designated by
Lederle. Lederle shall prior to each secondment advise CKK in
writing of the amounts of Staff Expenses actually paid to or in
respect of the respective individual during each of the
preceding twenty-four (24) calendar months prior to the
secondment. Lederle and Collagen and CKK will consult and agree
on bonus levels for seconded personnel in line with Lederle
general policies. Any travel expenses and other business costs
incurred by seconded staff will be for CKK's account.
(d) In relation to post-retirement shokutaku personnel seconded by
Lederle, CKK shall determine within six (6) months from the
commencement of secondment whether to retain such personnel as
its own personnel. Thereafter, the individual concerned shall at
his option be released by Lederle and retained by CKK.
(e) In relation to regular employees (sei ▇▇▇▇▇) seconded by Lederle
to CKK, CKK shall in each case decide within two (2) years from
the commencement of secondment whether to seek the transfer of
such personnel to CKK and shall notify Lederle at least ninety
(90) days prior to the expiration of the said period.
Thereafter, the individual concerned shall at his option be
released by Lederle and
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employed by CKK on such terms and conditions as the individual and CKK
may agree prior to such transfer. Upon transfer of any employee to CKK,
Lederle shall forthwith pay to such employee any retirement allowance
and other benefits which according to Lederle's internal rules shall
have accrued to such employee until the time of such transfer.
Notwithstanding the transfer, Lederle shall remain liable and shall hold
CKK harmless from and against any and all claims for retirement benefits
or other emoluments to which the transferred employee may be entitled by
virtue of any period of such individual's service with Lederle prior to
such transfer; provided that Lederle shall not be responsible for any
claims for retirement benefits or other emoluments to which the
transferred employee is or claims to be entitled by virtue of any period
of service with CKK after such transfer.
(f) CKK shall have the unfettered right to terminate the secondment of any
seconded staff with sixty (60) days' written notice to Lederle at any
time during two (2) years from the date of commencement of the
secondment. Upon receipt of such notice from CKK terminating any
secondment, Lederle shall promptly arrange the return of any such staff
to its own office.
(g) Save as otherwise provided herein, the parties' rights and obligations
in relation to any employees seconded from Lederle to CKK shall be
governed by the Secondment Terms attached hereto as Exhibit C.
(h) Save as stipulated in this Section 10 and in the Secondment Terms,
Lederle shall be solely responsible for all Staff Expenses and other
costs payable to or in respect of any Lederle employees currently or
formerly seconded to CKK, and shall hold CKK harmless from and against
any claims by employees or other parties for any such Staff Expenses or
other costs.
(i) For the avoidance of doubt, the parties confirm that the personal
preferences and legal rights of individuals to be transferred or
seconded to CKK will be respected. Nothing in this section shall be
interpreted as derogating from the parties' duty to comply with all
mandatory provisions of the Labor Standards Law.
(j) The parties hereto agree each to defend any legal action brought against
any party by any employee transferred or seconded hereunder and
recognize that such actions will be governed by Japanese law and
adjudicated upon by the Japanese courts. The parties shall make such
payments to one another as may be required to give effect to the rights
and obligations among the parties hereto in relation to any such
employee and such legal actions as set forth herein.
11. CONFIDENTIAL INFORMATION
Collagen, CKK and Lederle agree that during the term of this Agreement
and any subsequent agreement under which Lederle obtains distribution
rights to the Products
12
14
from Collagen or any affiliate or subsidiary of Collagen and for a
period of five years thereafter each shall keep completely confidential
and shall not publish or otherwise divulge or use for its own benefit or
for the benefit of any third party any information of a proprietary
nature furnished to it (the "receiving party") by the other party (the
"disclosing party") without the prior written approval of the disclosing
party in each instance, except to the extent that it is necessary to
divulge such information for the purposes of this Agreement or the
obtaining of governmental approval for the investigation or marketing of
the Products. Nothing in this Section 11 shall prevent disclosure or use
of information (i) already known to the receiving party; (ii) which is
or becomes public knowledge (iii) which is properly acquired by the
receiving party from a third party having the right to convey such
information. Information of a proprietary nature shall include but not
be limited to information concerning a party's products, proposed
products, marketing plans, methods of manufacture, customers or any
other information or materials in whatever form not generally known to
the public.
12. DEFENSE OF LEGAL ACTIONS AND INDEMNIFICATION
(a) LEGAL ACTIONS: Lederle agrees that Collagen shall defend, or at
its option settle, any claim, suit or proceeding brought against
Lederle on the issue of infringement of any Japanese patent,
trademark or other intellectual property right by reason of the
Products sold hereunder or the use thereof, subject to the
limitations hereinafter set forth. Collagen shall have sole
control of any such action or settlement negotiations, and
Collagen agrees to pay, subject to the limitations hereinafter
set forth, any final judgment entered against Lederle or its
customers on such issue. Lederle agrees that Collagen at its
sole option shall be relieved of the foregoing obligations
unless Lederle or its customers notifies Collagen in writing
within fifteen (15) days after it becomes aware of any such
claim, suit or proceeding and gives Collagen authority to
proceed as contemplated herein, and, at Collagen's expense,
gives Collagen proper and full information and assistance to
settle and/or defend such claim, suit or proceeding.
Notwithstanding the foregoing, Collagen assumes no liability for
any modification or combination of the Products with other
products or for any unauthorized or improper use or application
of the Products.
(b) INDEMNIFICATION BY COLLAGEN: Collagen agrees to indemnify
Lederle and to hold Lederle harmless from and against any and
all claims made by any person or entity arising out of
Collagen's manufacture, importation, testing, marketing,
distribution and sale of the Products hereunder, where and to
the extent that such damages are attributable to fault by
Collagen or its employees or agents in the manufacture of the
Products. Collagen hereby indemnifies and holds Lederle harmless
from and against any and all claims made against Lederle where
and to the extent that damages are alleged to have been caused
without any fault of Lederle by previously unknown or undetected
adverse effects or counterindications not disclosed by Collagen
in its package insert (as updated from time to time), in U.S.
Registration applications for the Products provided to Lederle,
or otherwise notified by Collagen to Lederle from time to time.
13
15
(c) INDEMNIFICATION BY LEDERLE: Lederle agrees to indemnify Collagen
and CKK and to hold Collagen and CKK harmless from and against
any and all claims made by any person or entity arising out of
Lederle's actions hereunder (including Lederle's importation,
testing, and distribution of the Products prior to the transfer
of the Product Approvals to CKK, or arising out of Lederle's
warehousing, management and distribution of Products thereafter
pursuant to any provisions under Section 6 ("Distribution of
Products") hereof), where and to such extent the damages are
attributable to the fault of Lederle or its employees or agents.
13. TERM AND TERMINATION
(a) TERM: This Agreement shall commence on July 1, 1998, and shall
continue in effect until June 30, 2001 unless earlier terminated
in accordance with the provisions hereof.
(b) EXTENSION OF TERM:
(i) Notwithstanding the provisions of the foregoing
subsection (a), CKK and Collagen shall have the
unfettered right to extend the term of this Agreement
for a further two (2) years under the terms and
conditions in effect at the end of the original term.
(ii) In the event that the Product Approvals shall not have
been transferred to and registered in favor of CKK on or
before May 31, 2001, CKK and Collagen shall,
notwithstanding the provisions of the foregoing
subsection (a), have the unfettered right to extend the
term of this Agreement for such further term as they may
in their unfettered discretion consider appropriate,
such term not to exceed (6) years. In this case, the
commission payable to Lederle during the period of any
such extension pursuant to subsection (c)(iii) of
Section 9 ("Ongoing Support and Distribution") hereof
shall, notwithstanding any other provision herein, be
reduced to (***) of CKK's selling price for such
Products unless such failure to transfer the Product
Approvals is demonstrably due to the reasons set forth
in subsection (c) of Section 8 ("Assignment
Consideration").
(iii) In the event of any extension of the term hereof
pursuant to the foregoing subsection, Lederle shall have
the right to terminate the agreement upon giving one
hundred and eighty (180) days' advance written notice,
provided always that Lederle shall not be permitted to
terminate the Agreement unless and until all of the
Product Approvals have been assigned to CKK.
(c) TERMINATION:
14
*** CERTAIN CONFIDENTIAL INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
16
(i) Without prejudice to any other provisions herein, either
Collagen and CKK or Lederle may, at their option, terminate this
Agreement as of the end of the Second Year upon giving one
hundred and eighty (180) days' prior written notice to Lederle
or Collagen and CKK, respectively.
(ii) Either party may terminate this Agreement upon thirty (30) days'
written notice in the event that the other party shall have
committed a serious breach of any of its material obligations
hereunder and such other party shall have failed to correct such
breach (if remediable) within thirty (30) days of receipt of a
written notice to remedy such breach.
(iii) This Agreement shall terminate automatically without further
notice or action by either party if the other party shall become
insolvent, shall make or seek to make an arrangement with or an
assignment for the benefit of creditors, or if proceedings in
voluntary or involuntary bankruptcy shall be instituted by, on
behalf of or against such other party, or if a receiver or
trustee of such other party's property shall be appointed.
(d) EFFECT OF TERMINATION:
In the event of expiration or termination of this Agreement for any reason:
(i) Lederle shall terminate all importation or distribution
activities in the Territory immediately upon expiration,
non-renewal or termination (collectively, "Termination") of this
Agreement and, except as otherwise provided herein, all rights
and obligations of the parties hereunder shall cease; provided,
however, that Termination shall not relieve the parties of any
obligations, including Lederle's obligations to pay purchase
prices, accrued prior to said Termination and CKK's obligation
to purchase inventory pursuant to Section 7(e) hereof. The
obligations of Collagen and Lederle pursuant to Section 7
("Assignment of Approvals") hereof shall survive any Termination
of this Agreement. Nothing herein shall limit any remedies which
a party may have for the other's default, except as set forth in
subsection (g) of Section 15 ("Limitation of Damages").
(ii) ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ shall promptly sell to CKK all
Products then in Lederle's inventory considered by CKK's Quality
Assurance Department to be in good condition for sale. The price
for any Products purchased by CKK shall be the price Lederle
paid Collagen for such Products to which shall be added actual
costs incurred by Lederle in connection with the customs
clearance, transportation and landing, transitory warehousing
and insurance of such Products by independent third-party
contractors, as well as Consumption Tax at the then applicable
rate. Any products not acquired by CKK shall be destroyed
forthwith in such manner as to prevent any possibility of reuse.
15
17
14. NO COMPETITION
The parties confirm and acknowledge that (i) Collagen has provided and
Lederle has received extensive and valuable proprietary technical and commercial
know-how and other business secrets in connection with this Agreement and the
preceding Distribution Agreements, (ii) such business secrets are capable of
exploitation in connection with products other than the Products; and (iii) the
provisions of this Article 14 are necessary and reasonable to protect Collagen's
and CKK's business secrets while enabling Lederle to make use thereof for the
purposes set forth in this Agreement.
(a) During the term hereof and for one (1) year (or such shorter
period as may be permitted under applicable statutes)
thereafter, Lederle shall refrain from importing, manufacturing
or selling, or being directly or indirectly involved in the
importation, manufacture or sale of any product which is
functionally similar, or competitive with, any Products, whether
in the territory or elsewhere.
(b) During the term hereof and for one (1) year (or such shorter
period as may be permitted under applicable statutes)
thereafter, Lederle shall not sell any Products to any party
other than CKK, or export or otherwise sell any Products within
or outside the Territory in any manner.
15 GENERAL PROVISIONS
(a) GOVERNING LAW: This Agreement shall be governed by and
interpreted in accordance with the laws of the State of
California and the United States excluding the Convention on
Contracts for the Sale of Goods and that body of laws known as
conflicts of laws.
(b) ARBITRATION: Any dispute or claim arising out of or in relation
to this Agreement shall be finally settled by binding
arbitration under the ICC Rules of Arbitration of the
International Chamber of Commerce by one (1) arbitrator
appointed in accordance with such Rules. The arbitration shall
be held in Tokyo, Japan, should either Collagen and/or CKK be
the party or parties demanding arbitration, or in San Francisco,
California, should Lederle be the party demanding arbitration,
Judgment on the award rendered by the arbitrator may be enforced
by any court of competent jurisdiction. Legal costs (including
attorneys' fees) incurred by either Lederle or Collagen and CKK
in connection with the successful enforcement or defense of any
rights hereunder shall be reimbursed in full by the unsuccessful
party.
(c) ENTIRE AGREEMENT: This Agreement represents the entire agreement
and understanding among the parties hereto with respect to
distribution of the Products, supersedes all previous agreements
and understandings related thereto and may only be amended or
modified in writing signed by authorized representatives of the
parties hereto.
16
18
(d) INTEREST: Any sums payable hereunder but unpaid for more than
thirty (30) days from the date when payment became due shall
bear interest at a rate of fifteen (15) per cent per annum
until full and final payment. The parties acknowledge that any
default to make payments as due constitutes a breach of this
Agreement, and that the aforesaid interest rate constitutes a
fair and reasonable pre-estimate of direct and indirect losses
likely to be suffered by the respective payee as a result of any
payment default.
(e) ASSIGNMENT: Neither Collagen or CKK nor Lederle shall assign any
of its rights or obligations pursuant to this Agreement except
to a successor to substantially all of its business by merger or
other form of reorganization.
(f) NOTICES: Any notice required or permitted to be given hereunder
shall be in writing and in English and sent by facsimile (with
confirmation sent by registered airmail) or by pre-paid
registered air mail, return receipt requested, addressed to the
parties at their respective addresses as the parties may
designate in writing. Notice, including notice of change of
address, shall be deemed served on the business day following
transmission in the case of notice sent by facsimile or seven
(7) days after deposit in the mail for notice sent by pre-paid
registered airmail.
(g) LIMITATION OF DAMAGES: Save as provided herein, no party shall
be liable to any other for incidental, consequential or punitive
damages, even if such other party shall have advised such party
of the possibility of the same.
(h) FORCE MAJEURE: Each of the parties hereto shall be excused from
the performance of its obligations hereunder in the event and to
the extent that such performance is prevented by force majeure,
and such excuse shall continue so long as the condition
constituting such force majeure continues plus thirty (30) days
after the termination of such condition. For the purposes of
this Agreement, force majeure is defined to include causes
beyond the control of such party, including without Limitation
acts of God, acts, regulations or laws of any government, war,
civil commotion, destruction of production facilities or
materials by fire, earthquake or storm labor disturbances,
epidemic and failure of public utilities or common carriers.
(i) SHAREHOLDERS NOT LIABLE: Shareholders of Lederle and Collagen
shall have no responsibility or liability with respect to rights
and obligations contained in this Agreement.
(j) HEADINGS: Headings contained herein are for convenience only and
shall not affect the interpretation of any of the provisions of
this Agreement.
17
19
(k) NO WAIVER. Failure by a party to assert any rights hereunder
shall not be construed as a waiver of those or any other rights.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their authorized representatives as of the day and year first above
written.
COLLAGEN CORPORATION LEDERLE (JAPAN), LTD.
By /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇ By
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇▇▇▇
Title C.E.O. Title
COLLAGEN KK
By /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇
Title Director
18
20
(k) NO WAIVER. Failure by a party to assert any rights hereunder
shall not be construed as a waiver of those or any other rights.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their authorized representatives as of the day and year first above
written.
COLLAGEN CORPORATION LEDERLE (JAPAN), LTD.
By By /s/ ▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇ ▇▇▇▇▇▇▇
Title Title President,
Lederle (Japan), Ltd.
COLLAGEN KK
By
Title
18
21
EXHIBIT A
PRODUCTS CODE PRICE (US$)
[***]
*** CERTAIN CONFIDENTIAL INFORMATION ON THIS PAGE HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
22
EXHIBIT B
(i) Collagen Contact Personnel
(ii) International Marketing Recall Guideline
(iii) International Marketing Receiving of Collagen Products Guideline
(ii) International Marketing Shipments to Customers Guideline
(iii) International Marketing Report of Technical and Medical Complaints
Guidelines
23
Collagen International, Inc.
COLLAGEN CONTACT PERSONNEL
TITLE NAME PHONE FAX
Placing Orders
Export Supervisor ▇▇▇ ▇▇▇▇▇▇▇ ▇-▇▇▇-▇▇▇ 2413 1-650-354 4894
Medical Information and
Product Safety
Manager of Medical
Information and Product
Safety ▇▇▇▇▇ ▇▇▇▇▇ ▇-▇▇▇-▇▇▇ 4926 1-650-354 4695
and ▇-▇▇▇-▇▇▇ 4894
Technical Complaints
International Marketing
Specialist ▇▇▇▇▇ ▇▇▇▇▇▇ ▇-▇▇▇-▇▇▇ 4647 1-650-354 4894
Marketing Communications
International Marketing
Specialist ▇▇▇▇▇ ▇▇▇▇▇▇ ▇-▇▇▇-▇▇▇ 4647 1-650-354 4894
Regulatory
International Regulatory
Associate ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇-▇▇▇-▇▇▇ 4953 1-650-354 4894
Trademarks
Litigations Specialist ▇▇▇ ▇▇▇▇▇▇▇▇ ▇-▇▇▇-▇▇▇ 4686 1-650-856 0208
All the above communications should always be copied to ▇▇▇▇ ▇▇▇▇▇▇▇, Director
of Distributor Markets in France:
Tel: ▇▇-▇-▇▇-▇▇ 85 85
Fax: ▇▇-▇-▇▇-▇▇ 79 00
24 March 1998
Revision 1
24
Collagen International, Inc.
INTERNATIONAL MARKETING RECALL GUIDELINE
In the event that Collagen Corporation should determine the recall of a product
or product lot, this will be advised to the distributor by fax.
The distributor will:
1. Recover from customer, whenever possible, unused product and keep it in
quarantine in his warehouse, pending decision from Collagen Corporation.
Collagen may, at its discretion, either credit product quarantined or replace
it.
2. Distributor undertakes, if requested, to provide proof of destruction of
quarantined product and to report back to Collagen product successfully recalled
from field or warehouse.
25 May 1995
Revision 0
25
Collagen International, Inc.
INTERNATIONAL MARKETING
SHIPMENTS TO CUSTOMERS GUIDELINE
A. Gel ice bags shall be placed along the inside styrene walls of the
shipping carton. To avoid freezing the product, it shall not be packed
with the gel ice bags until they thaw to the acceptable shipping
temperature range.
1. The ice bag temperature is measured by sandwiching a
temperature probe between 2 ice bags until the probe meter is stable and
resting within the correct ice shipping range of -2 Degrees to 0
Degrees C.
B. Syringes can sit in a controlled room-temperature environment (up to 27
Degrees C) for a maximum of 8 hours in preparation for shipment.
C. Products sealed into cartons designed as above (A) can be considered
protected from unacceptable temperatures for at least 3 days.
D. The objective when shipping collagen is to provide maximum protection.
The following instructions shall be visible on all shipping
documentation in an appropriate language:
Products are perishable and packed with gel ice bags.
If delayed, place cartons in refrigeration:
+2 to +8 Degrees C
DO NOT DELAY. DO NOT FREEZE
25 May 1995
Revision 0
26
Collagen International, Inc.
INTERNATIONAL MARKETING
RECEIVING OF COLLAGEN PRODUCTS GUIDELINE
A. Upon receipt open each Shipping carton and confirm that the syringes are
still "cool" to the touch (between 2 Degrees - 25 Degrees C). If the
product feels "warm" notify the Export Supervisor, (ES) at once for
further instructions:
B. Verify the contents of each carton e.g., Collagen code and lot number,
expiration date and quantity. Report any discrepancies to the ES
immediately for further instructions.
C. Immediately following receiving inspection, all syringes shall be stored
between 2 Degrees - 10 Degrees C.
D. Styrene shipping cartons and gel ice refrigerant bags are re-usable.
25 May 1995
Revision 0
27
INTERNATIONAL MARKETING
REPORT OF TECHNICAL AND MEDICAL COMPLAINTS GUIDELINES
DEFINITIONS:
Complaint - Information received that constitutes a complaint refers to any
written or oral expression of dissatisfaction relative to the identity, quality,
durability, reliability, safety, effectiveness, or performance of one of
Collagen Corporation's marketed products.
Technical Complaint - Complaints of a technical nature are complaints that are
not of a medical nature, e.g. complaints regarding the syringe, syringe cap,
needles, etc.
Medical Complaint - Complaints of a medical nature are those complaints that
involve a human being.
GUIDELINES:
A. Technical Complaints
Technical complaints from national customers should be forwarded
to the International Marketing Specialist, ensuring that
sufficient information is available for investigation by
Collagen Corporation.
B. Medical complaints
Medical complaints should be forwarded to the Manager of Medical
Information and Product Safety within 48 hours of initial
receipt of information, using the attached form (International
Clinical Report). Distributors are responsible for submitting
local reports to their regulatory agencies in accordance with
local regulations in the countries of their responsibility.
Collagen International distributors are responsible for
maintaining a tracking system for Collagen and LipoMatrix
implants delivered to physicians, and for instructing doctors to
maintain a data base of patients to whom Collagen implants have
been administered.
11 July 1997
Revision 1
28
COLLAGEN CORPORATION
INTERNATIONAL COMPLAINT REPORT FORM
For Internal use only:
Complaint No. ___________________
ARM No. _______________________
DESCRIPTION OF THE COMPLAINT
ORIGINATOR OF THE COMPLAINT: [ ] Physician [ ] Patient [ ] Distributor
DOES THIS COMPLAINT INVOLVE A HUMAN BEING? [ ] Yes (Medical Complaint)
[ ] No (Technical Complaint)
DESCRIPTION: ___________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
________________________________________________________________________________
================================================================================
PHYSICIAN INFORMATION
Name _________________________________ Specialty ______________________________
Address ________________________________________________________________________
City _________________________________ Country ________________________________
Postal Code _____________ Telephone _____________________ Fax Number ___________
================================================================================
PRODUCT INFORMATION
----------------------------------------------------------------------------------------------------------------
PRODUCT NAME(S) PRODUCT PRODUCT VIGILANCE(TM) ID IMPLANT IS PRODUCT BEING
CATALOG/ LOT NUMBER VOLUME RETURNED?
CODE NUMBER(S) IF NO, EXPLAIN
NUMBER(S)
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
WAS THIS THE FIRST TIME THE DEVICE WAS USED? [ ] YES [ ] NO (EXPLAIN IN DESCRIPTION ABOVE)
================================================================================================================
REPORTED BY: _______________ DATE COMPLAINT RECEIVED BY COLLAGEN OR LIPOMATRIX / /
DD MMM YY
CONTINUE TO PAGE 2 FOR MEDICAL COMPLAINTS Page 1
29
COLLAGEN CORPORATION
INTERNATIONAL COMPLAINT REPORT FORM
For Internal use only:
Complaint No. ________
ARM No. _________
MEDICAL COMPLAINT INFORMATION
PATIENT ___, ____ BIRTH __/___/__ OR AGE ___ SEX ____ WEIGHT ______ HEIGHT ____
Initial Last First Date DD MMM YY yrs M/F kgs/lbs cm/inches
__________________________________________________________________________________________
INDICATION FOR WAS THIS THE FIRST TIME THE DATE OF (LAST) WHAT SITES WERE
IMPLANTATION/DIAGNOSIS PATIENT WAS IMPLANTED WITH IMPLANTATION IMPLANTED?
THIS PRODUCT? Y/N DD/MMM/YY
__________________________________________________________________________________________
__________________________________________________________________________________________
__________________________________________________________________________________________
LOCAL SYMPTOM(S) AT IMPLANT SITE(S) SITE(S) INCIDENT DATE RESOLUTION DATE
DD/MMM/YY DD/MMM/YY
__________________________________________________________________________________________
__________________________________________________________________________________________
Were the local symptoms considered by the physician to be product related?
[ ] Yes [ ] Probably [ ] Possibly [ ] Probably not [ ] No
Diagnosis or etiology for local symptoms:_________________________________
__________________________________________________________________________________________
NON-LOCAL SYMPTOM(S) SITE(S) INCIDENT DATE RESOLUTION DATE
DD/MM/YY DD/MM/YY
__________________________________________________________________________________________
__________________________________________________________________________________________
Were the non-local symptoms considered by the physician to be product related?
[ ] Yes [ ] Probably [ ] Possibly [ ] Probably not [ ] No
Diagnosis or etiology for non-local symptoms:______________________________
CONCOMITANT MEDICAL INFORMATION
Relevant History __________________________________________________________
Test Site Evaluation: (Zyderm and Zyplast only)
DD MMM YY
Test Date __/___/__ Lot #_______ Test Response Positive? [ ] Yes [ ] No
Retest Date __/___/__ Lot #_______ Retest Response Positive? [ ] Yes [ ] No
Concomitant Medical Products _______________________________________________
Lab Work ___________________________________________________________________
Precipitating Events _______________________________________________________
Residual/Sequelae___________________________________________________________
TREATMENT INFORMATION: Was treatment required for the symptoms? [ ] Yes [ ] No
EFFECTIVE?
__________________________________________________________________________________________
DATE MEDICAL OR SURGICAL INTERVENTION ROUTE YES NO
__________________________________________________________________________________________
__________________________________________________________________________________________
------------------------------- --------------------------------
Collagen/Lipomatrix/Distributor Collagen/Lipomatrix/Distributor
Reporter Name (please print) Reporter Signature
Page 2
30
COLLAGEN CORPORATION
INTERNATIONAL COMPLAINT REPORT FORM
Continue to page 3 for Implant Retrieval Record as appropriate
Page 3
31
COLLAGEN CORPORATION
INTERNATIONAL COMPLAINT REPORT FORM
For Internal Use only:
Complaint No. _____________
ARM No. _____________
IMPLANT RETRIEVAL RECORD
Has this complaint been previously reported? Yes [ ] No [ ]
If Yes, Physician's Name: ________________, Patient's Initials: ______,
Original Complaint No. (if known): ____________, Date of Explantation: ________
REASON FOR REMOVAL
Routine series [ ] Liability claims [ ] Allergy [ ]
Complaint [ ] Clinical Pain [ ]
Research [ ] Investigation [ ] Infection [ ]
Documentation [ ] Failure [ ] Other (specify) ______________
ADDITIONAL INFORMATION
Antibiotics pre-op [ ] peri-op [ ] post-op [ ] prophylactic [ ]
Relevant pharmaceuticals duration _____________________________________________
_______________________________________________________________________________
Post-operative treatment ______________________________________________________
_______________________________________________________________________________
DEVICE DIAGNOSIS (PER TRIAGE)
Observations prior to removal (functional)
Objectives _______________________________________________________________
Observational ____________________________________________________________
Observations at removal
Yes No Doubt N/A Yes No Doubt N/A
Normal tissue [ ] [ ] [ ] [ ] Bone reaction [ ] [ ] [ ] [ ]
Bursal fluid [ ] [ ] [ ] [ ] Discoloration [ ] [ ] [ ] [ ]
Scar tissue [ ] [ ] [ ] [ ] Implant debris [ ] [ ] [ ] [ ]
Loose implant [ ] [ ] [ ] [ ] Infection [ ] [ ] [ ] [ ]
Granulation tissue [ ] [ ] [ ] [ ] Other (specify) [ ] [ ] [ ] [ ]
Additional Material Provided for Analyses
Yes No
Mammographs [ ] [ ] how many______
Tissue [ ] [ ] type____ origin____
Bacteriology specimen [ ] [ ] type____ origin____
Immunology specimen [ ] [ ] type____ origin____
Fluid [ ] [ ] type____ origin____
Photographs [ ] [ ]
Pathology reports [ ] [ ]
Surgical reports [ ] [ ]
Additional documentation (specify)_____________________________________________
___________________________ _ _/_ _ _/_ _
Physician Signature DD MMM YY
32
EXHIBIT C
SECONDMENT TERMS
33
SECONDMENT TERMS
THESE SECONDMENT TERMS GOVERN, AS BETWEEN LEDERLE AND CKK, the conditions of
labor, expenses, burdens therefor and the like for those individuals
(hereinafter, "Seconded Persons") to be seconded and to perform work while
maintaining their status as employees of Lederle.
ARTICLE 1. SECONDMENT (SHUKKO).
1. LEDERLE and CKK shall agree by advance mutual consultation as to the
identity of each Seconded Person, the persons who are the object thereof
(taishousha), the period of secondment as well as the organizational
assignment (shozoku), position (chii), responsible duties (tantou-gyoumu)
and place of performance of work for the Seconded Person at CKK's place of
business, and in the event that there will occur change to any of the
same following secondment, notice thereof shall be given to LEDERLE by CKK
no less than one month prior thereto and the consent of LEDERLE shall be
obtained.
2. The period of secondment of a Seconded Person shall be two (2) years in
principle. However, with regard to an individual being employed for a
period previously determined by LEDERLE, in principle the period of
secondment shall be from the day of commencement of the secondment until
the expiration day of such determined period.
3. The time of commencement of secondment as well as the day of return
each shall be the day of LEDERLE's official order (hatsureibi).
ARTICLE 2. WORK.
Seconded Persons, in principle, shall obey CKK's employee work rules
(shuugyou-kisoku) and standing work orders and provisions (fukumu-kiritsu), and
shall perform work in accordance with CKK's directions and orders
(shiki-meirei). However, LEDERLE's rules and provisions shall apply with regard
to salary (kyuuyo), severance allowances (taishoku-kin), severance (taishoku),
dismissal (kaiko), retirement age (teinen), temporary work suspensions
(kyuushoku) and the like.
ARTICLE 3. WORK HOURS, DAYS OFF, LEAVES.
1. CKK's rules and provisions shall apply with regard to work hours
(roudou-jikan) and days off (kyuujitsu).
2. Without regard to the foregoing Paragraph, LEDERLE's rules and provisions
shall apply with regard to annual paid leave (nenji-yuukyuu-kyuuka) as
well as special paid leave (tokubetsu-yuukyuu-kyuuka).
ARTICLE 4. SALARY, SEVERANCE ALLOWANCE.
Salary (kyuuyo) and severance allowance (taishoku-kin) shall be provided for as
follows:
1) Salary:
The salary (kyuuyo), bonuses (shouyo), housing allowances
(juutaku ▇▇▇▇▇, juutaku-hi hojo ▇▇▇▇▇), family allowance
(fuyou ▇▇▇▇▇), meal allowance (regional allowance -- chiiki
▇▇▇▇▇), commuting allowance (tsuukin ▇▇▇▇▇), overtime
allowance (jikangai ▇▇▇▇▇) and sales allowance (gaikin ▇▇▇▇▇)
of Seconded Persons during the period of secondment shall be
paid, subtracting miscellaneous deductions (sho-koujyogaku),
by LEDERLE in accordance with LEDERLE's rules and provisions.
However, when there occur difficulties in application of
LEDERLE's salary rules and provisions (kyuuyo-kitei-ni-yori-
gatai-jiyuu) with regard to a Seconded Person's responsible
duties (tantou-gyoumu) and the like as assigned by CKK,
LEDERLE and CKK shall determine the handling of the same by
mutual consultation.
2) Severance Allowance:
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Severance allowance (taishoku-kin) to be paid at the time of severance
(taishoku) of Seconded Persons from LEDERLE shall be paid by LEDERLE
in accordance with LEDERLE's own rules and provisions.
ARTICLE 5. SOCIAL INSURANCE (SHAIKAI HOKEN)
LEDERLE will continue to provide health insurance (kenkou hoken), welfare
annuity insurance (kousei nenkin hoken) employment insurance (koyou hoken) and
workmen's accident compensation (roudousha saigai hoshou) coverage for all
Seconded Persons. CKK will provide workmen's accident compensation insurance
(roudousha saigai hoshou hoken) coverage.
ARTICLE 6. BUSINESS TRAVEL EXPENSES.
CKK's rules and provisions shall apply with regard to business travel expenses
(shutchou-ryohi) and travel allowances (shutchou nittou).
ARTICLE 7. WELFARE BENEFITS.
Welfare benefits (fukuri-kousei), in principle, shall be pursuant to LEDERLE's
rules and provisions. However, CKK may apply its own rules and provisions to
additionally established benefit items.
ARTICLE 8. PERSONNEL EVALUATIONS.
Personnel evaluations (jinji-kouka) of Seconded Persons shall be made initially
by CKK and, using the same as a reference, shall be determined finally by
LEDERLE pursuant to LEDERLE's own rules and provisions. Further, CKK shall
provide to LEDERLE data and information necessary for such purpose.
ARTICLE 9. WORK ADMINISTRATIVE MATTERS.
Administrative matters regarding the work (kinmu-kanri) of Second Persons shall
be performed by CKK, with report thereof to be provided LEDERLE in writing each
month.
ARTICLE 10. BURDENS FOR EXPENSES.
1. The respective burdens for expenses (hiyou-no-futan) with regard to
Seconded Persons shall be as follows:
1) Salary (kyuuyo), bonuses (shouyo) and various allowances (sho-▇▇▇▇▇):
To be borne in full by CKK.
2) Health insurance premiums (kenkou-hoken-ryou), welfare pension
insurance premiums (kousei-nenkin-hoken-ryou), employment insurance
premiums (koyou-hoken-ryou):
CKK shall bear portion to be borne by the enterprise.
3) Workmen's accident compensation insurance premiums
(roudousha-saigai-hoshou-hoken-ryou):
To be borne in full by CKK.
4) Workmen's accident compensation (roudousha-saigai-hoshou):
In addition to payments determined by law there shall be made
supplementary payments as determined by LEDERLE and with the
burden therefor to be borne by CKK.
5) Reserves for severance payments (taishoku-kyuuyo-hikiatekin):
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Reserves for severance payments shall be accumulated by LEDERLE, with
CKK to reimburse the amount corresponding thereto.
6) Business Travel Expenses (shutchou-ryohi) and Travel Allowances:
To be borne in full by CKK.
7) Congratulations & Condolence Money (keichou-mimai-kin):
To be borne by both parties in accordance with the respective rules
and provisions of LEDERLE and CKK.
8) Regular Physical Examinations (teiki-kenkou-shindan) and other safety &
hygiene (anzen-eisei) expenses:
CKK shall bear portion to be borne by the enterprise.
9) Welfare benefits (fukuri-kousei):
The burden for welfare benefits shall be determined by separate
consultation and agreement of LEDERLE and CKK. However, in the
event that the rules and provisions of CKK are applied in the
manner provided in the proviso of Article 7, above, CKK shall bear
the burden therefor.
10) Expenses regarding Training & Education (koushuu-kyouiku):
CKK shall bear the total burden therefor when needed for the
performance of CKK's work duties. However, in principle LEDERLE
shall bear the burden in cases where a Seconded Person participates
in LEDERLE's own employee education and the like.
11) Relocation expenses upon commencement & termination of secondment
(tenkyo-hiyou):
In the cases of the commencement of secondment and where at the
termination of secondment, Seconded Persons will return to LEDERLE
necessitating relocation, CKK shall bear the total burden as to the
expenses therefor.
2. CKK shall pay by remittance and pursuant to invoice therefor from LEDERLE,
to the account designated by LEDERLE, the costs and expenses to be borne by CKK.
ARTICLE 11. PERSONAL CHANGES.
In the event of any change in the family situation, address or other personal
circumstances of a Seconded Person, LEDERLE and CKK shall mutually notify the
other without delay. Furthermore, matters for which notice is required shall be
separately determined.
ARTICLE 12. CHANGE TO CONDITIONS OF WORK, ETC.
In the event of revision to rules and provisions concerning established work
hours (shotei-roudou-jikan), days off (kyuujitsu), leaves (kyuuka), travel
expenses (ryohi), welfare benefits (fukuri-kousei) or like change to work
conditions (roudou-jouken) by either LEDERLE or CKK, the other party shall be
informed without delay.
ARTICLE 13. COMMENDATIONS & SANCTIONS (HYOU-SHOU, SEISAI).
In principle, commendations and sanctions shall be determined pursuant to CKK's
rules and provisions. However, with regard to dismissal (kaiko), commendation
for long years of continuous service and other items
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separately determined by agreement between LEDERLE and CKK, the rules and
provisions of LEDERLE shall be followed.
ARTICLE 14. MAINTENANCE OF CONFIDENTIALITY.
1. Neither LEDERLE nor CKK shall divulge or disclose to a third party any
business related secret of the opposite party learned in the course of
performance of this Agreement. However, there shall be excepted from the
foregoing publicly known matters and matters which become public other
than through the responsibility of the party itself.
2. Both LEDERLE and CKK shall cause Seconded Persons to maintain as
confidential each other's business secrets, and shall not allow the
other party's business secrets to be disclosed or divulged, nor to be
used for the party's own benefit or other purposes.
ARTICLE 15. COMPENSATION FOR DAMAGES (SONGAI-BAISHOU).
LEDERLE and CKK may demand from the opposite party compensation for damages in
the event that the opposite party has breached the duty to maintain
confidentiality pursuant to the preceding Article, or in the event of there
having been suffered damages pursuant to a Seconded Person's breach of business
order and discipline (kigyou-chitsujo-ihan) or the like.
ARTICLE 16. EARLY TERMINATION.
Pursuant to proper grounds therefor, when LEDERLE or CKK find it necessary to
terminate this Agreement, or to change, suspend or stop the secondment of
individual Seconded Persons, they may terminate this Agreement or make such
stoppage or the like to secondment upon three (3) months' prior notice thereof
to the opposite party.
ARTICLE 17. PERSONS RESPONSIBLE FOR LIAISON.
LEDERLE and CKK hereby determine that the following individuals are the
responsible liaison persons with regard to this Agreement through whom shall
occur necessary communications, notifications and coordination between the
parties:
LEDERLE: Personnel Manager (Head, Personnel Section)
CKK: Personnel Manager
ARTICLE 18. PROHIBITION OF RE-SECONDMENT.
CKK may not re-second Seconded Persons to another company or the like.
ARTICLE 19. ADDITIONAL MATTERS.
With regard to matters not provided for in this Agreement or should there arise
doubt as to the content hereof, LEDERLE and CKK shall mutually consult thereon
with a spirit of good faith and sincerity, and shall resolve the same.
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