Execution Copy
* Confidential portions omitted and filed separately with the Commission.
LICENSE AGREEMENT
Dated as of March 10, 1995
Between
IMMUNOMEDICS, INC.
and
MALLINCKRODT MEDICAL, B.V.
License Agreement
This License Agreement is made and effective as of the 10th day of
March, 1995, by and between Immunomedics Inc., a Delaware corporation
located at 300 American Road, Morris Plains, New Jersey, USA (hereinafter
referred to as IMMU) and Mallinckrodt Medical, B.V., a corporation
organized under the laws of The Netherlands with its principal offices
located at Westerduinweg 3, Petten, The Netherlands (hereinafter referred
to as "MM")
WHEREAS, IMMU possesses rights in and to an in-vivo diagnostic
imaging product known as CEA-Scan , and IMMU desires to expedite the
establishment of CEA-Scan as a significant product in the European
pharmaceutical and nuclear medicine marketplace; and
WHEREAS, IMMU has completed Phase III clinical trials for CEA-Scan for
colorectal cancer imaging, has Phase III clinical trials for CEA-Scan
underway for lung cancer imaging and is in the process of completeing
Phase II clinical trials for CEA-Scan for breast cancer imaging; and
WHEREAS, MM, has considerable knowledge in distributing,
promoting, detailing and marketing nuclear medicine products in Europe and
has in place an experienced distribution, marketing and selling organization
to address all key European markets; and
WHEREAS, MM desires to obtain the exclusive rights to distribute
CEA-Scan in European markets for use in colorectal, breast and lung
cancer imaging; and
WHEREAS, MM is willing to commit substantial financial resources
as well as its distribution, marketing and selling organization to the
introduction and promotion of CEA-Scan in Europe, and MM is willing to
assist IMMU in establishing and monitoring selected studies (other than full
scale clinical trials) in European clinical centers relating to breast and
lung cancer imaging; and
WHEREAS, IMMU believes that a distribution, promotion, and
marketing arrangement with MM regarding CEA-Scan would be desirable
and fully compatible with IMMU's worldwide marketing and business
objectives with respect to CEA-Scan ;
NOW, THEREFORE, in consideration of the premises and the mutual
covenants contained herein, IMMU and MM hereby agree as follows:
ARTICLE 1
DEFINITIONS
As used herein, the following terms shall have the meanings described below:
1.01 "Affiliate" shall mean, with respect to any Person, any other
Person which, directly or indirectly, owns or controls, or is
owned or controlled by, or is under common control with, the
specified Person. For purposes of this definition, the term
"control" (including, with correlative meanings, the terms
"controlling", "controlled by", and "under common control
with") as applied to any Person, means the possession, directly
or indirectly, of the power to direct or cause the direction of the
management of that Person, whether through ownership of
voting securities, by means of contractual arrangements or
otherwise.
1.02 "Agreement" shall mean this License Agreement, as the same
may be modified, amended or supplemented from time to time.
1.03 "Confidential Information" shall mean information relating to the
business, products or services of a party to this Agreement which
is either non-public, confidential or proprietary in nature;
provided, however, that Confidential Information shall not
include (i) information which has come within the public domain
through no fault or action of the other party; (ii) information that
was known to the other party on prior to its disclosure hereunder
or in connection with the negotiation of this Agreement; or (iii)
information which becomes rightfully available to the other party
on a non-confidential basis from any third party, the disclosure
of which to such other party does not violate any contractual or
legal obligation the third party has to the first party with respect
to such Confidential Information. Without limiting the
generality of the foregoing, Confidential Information shall
include: (x) information which relates to the Product and its
manufacture, sale or use, including financial statements, costs
and expense data, marketing and consumer data, production data,
know-how, trade secrets, secret processes and formulae,
technical data and reports including pharmacological, clinical,
chemical, biochemical, toxicological, pharmacokinetic,
manufacturing and formulation data, or any other information
relating to the Product which is not generally ascertainable from
public or published information, regardless of whether such
information was provided pursuant to the terms of this
Agreement, by request of the other party or in any other manner;
(y) information developed or to be developed by a party to this
Agreement, its Affiliates, and/or clinicians, and all material and
information submitted to and/or filed with a governmental
regulatory agency or any other equivalent agency covering the
Product; and (z) information related to the Product contained in
all documents submitted in connection with regulatory
submissions throughout the world covering the Product,
including, by way of example: New Drug Applications
("NDAs"), Clinical Trial Certificates ("CTCs"), Product License
Applications ("PLAs"), and Autorisations de Mise au Marche
("AMMs").
1.04 "Coordinator" shall mean the individual designated as the
principal representative of a party pursuant to the provisions of
Section 5.01 hereof.
1.05 "Coordinating Committee" shall mean the committee of
representatives of IMMU and MM established pursuant to the
provisions of Section 5.02 hereof.
1.06 "Distribution Date" as to each country within the Territory shall
mean the first date upon which the Product is distributed for
commercial sale to independent third parties in such country. The
"First Distribution Date" shall mean the first of such Distribution
Dates in a Major Market.
1.07 "Effective Date" shall mean the date first written above.
1.08 "FDA" shall mean the U.S. Food & Drug Administration.
1.09 "Gross Sales" shall mean the gross invoiced price for the sales of
the Product (i) to end users, in the case of sales by MM or its
Affiliates, or (ii) to local distributors, in the case of sales by
Recognized Agents; provided, however, that Gross Sales shall
exclude sales of the Product which are intended for resale (x)
between MM and its Subdistributors or (y) among such
Subdistributors.
1.10 "IMMU Patents" shall mean those patents owned by IMMU or
exclusively licensed to IMMU covering the Product.
1.11 "Major Market" shall mean each and any one of the following
countries: Germany, France, Italy, and the United Kingdom.
1.12 "Net Sales" shall mean Gross Sales less (i) any credits and
allowances actually granted by MM or its Subdistributors to their
respective customers with respect to the Product, including,
without limitation, credits and allowances on account of price
adjustments, returns, discounts, and charge-backs, each only to
the extent given by such Person in the ordinary course of
business to its customers, (ii) any sales, excise, value-added,
turnover or similar taxes and any duties and other governmental
charges imposed upon the importation, use or sale of the
Product, (iii) transportation, insurance and handling expenses if
separately invoiced and directly chargeable to such sales. For
the purpose of computing Net Sales, MM shall first compute the
conversion of the applicable sales figure from the local currency
into U.S. Dollars, utilizing the "average exchange rate", as
hereinafter defined, for the calendar quarter in which such Net
Sales were made. The "average exchange rate" shall be
computed by (i) adding the mid-point between the buying and
selling exchange rates of local currency into U.S. Dollars, as
published in The Wall Street Journal, at the close of business on
the last business day of each month of such quarter and (ii)
dividing the sum by three (3).
1.13 "Net Selling Price Per Vial" shall mean, as to any semi-annual
period, the Net Sales for such period divided by the number of
vials of Product sold by MM and its Subdistributors during such
period.
1.14 "Person" shall mean any individual, corporation, partnership,
business trust, business association, governmental entity,
governmental authority or other legal entity.
1.15 "Product" shall mean IMMU's in-vivo cancer diagnostic imaging
agent consisting of a murine anti-CEA monoclonal antibody
Fab' fragment, known as ("IMMU-4" or "CEA-Scan "). The
term Product shall include, without limitation, bulk forms of the
Product ("Bulk Vialed Product") and/or finished and packaged
dosage units of the Product ("Finished Product").
1.16 "Recognized Agent" shall mean a Person who is not an Affiliate
of MM and who MM uses in the normal course of its business to
market or distribute its products in a particular country within the
Territory.
1.17 "Subdistributor" shall mean (i) any Affiliate of MM or (ii) any
Recognized Agent of MM appointed as a Subdistributor of MM
under and pursuant to the provisions of Section 3.05.
1.18 "Territory" shall mean the countries within Europe listed on
Schedule A hereto , subject to the elimination from such list of
certain countries pursuant to the provisions of Section 2.03
hereof.
ARTICLE 2
APPOINTMENT AND LICENSE GRANTS
2.01 Appointment. IMMU hereby appoints MM as its exclusive
distributor to launch, detail, promote, advertise, distribute and
sell the Product for use in colorectal, breast and lung cancer
diagnostic imaging in every country in the Territory during the
term of this Agreement.
2.02 License. In furtherance of its position as IMMU's exclusive
distributor in the Territory, IMMU hereby grants MM an
exclusive, royalty free, license during the term of this Agreement
(i) under the IMMU Patents to use and sell the Product in the
Territory for colorectal, breast and lung cancer diagnostic
imaging, and (ii) to use IMMU's Confidential Information and
the trademark CEA-Scan or such other mark(s) as IMMU shall
cause to be registered for the Product in the Territory in
connection with the use and sale of the Product for colorectal,
breast and lung cancer diagnostic imaging. This license shall not
restrict IMMU's right to license or use its patents, trademarks or
Confidential Information for other purposes which do not
conflict with MM's rights hereunder or in other territories.
2.03 Territory. It is the parties intent that the Territory shall include
those European countries in which MM has the intention to take
an active role, either directly or through Subdistributors, in the
registration and marketing of the Product and in which, during
the term of this Agreement, it uses its best efforts consistent with
accepted business practices in the marketing of nuclear imaging
products and legal requirements to register and actively market
the Product. If at any time during the term of this Agreement,
MM shall decide that it has no interest in marketing the Product
in a particular country within the Territory, it shall so notify
IMMU in writing. In addition, if by the second anniversary of
the date of this Agreement, MM has not developed and
implemented a marketing plan (as contemplated by Section 5.03
hereof) with respect to a particular country within the Territory,
IMMU shall have the right to notify MM in writing of its
election to proceed on its own or seek to obtain another
distributor or agent in such country. Upon delivery of any such
notice by either party, the country or countries identified in such
notice shall, for all purposes under this Agreement, cease to be
included within the definition of the Territory. Upon any such
reduction in the Territory, the parties shall enter into good faith
negotiations to make suitable arrangements to effect an orderly
transition and to permit progress to be made in the registration
and marketing of the Product in the particular country.
2.04 Reservation of Rights. IMMU reserves to itself and its Affiliates
the right to manufacture, market and sell the Product in and for
countries located outside the Territory, including without
limitation, the right to appoint other Persons as marketing
representatives, distributors and manufacturers for sale of the
Product outside of the Territory.
ARTICLE 3
ACCEPTANCE; MARKETING OBLIGATIONS
3.01 Acceptance. MM shall use its best efforts consistent with
accepted business practices in the marketing of nuclear imaging
products and legal requirements to launch, detail, promote,
advertise, distribute and sell the Product for use in colorectal,
breast and lung cancer diagnostic imaging in every country in the
Territory during the term of this Agreement exercising the same
diligence and adhering to the same standards as MM would
adopt in launching, detailing, promoting, advertising, distributing
and selling a major nuclear medicine or pharmaceutical product
of its own innovation, with the objective to make the Product the
market leader in its field of intended use.
3.02 Promotion Standard. In launching, detailing, promoting,
advertising, distributing and selling the Product, MM shall
maintain and adhere strictly to the diagnostic claims of the
Product as established by IMMU and approved by the health
authorities in each country in the Territory. All promotional
materials prepared by MM and all promotional activities relating
to the Product sold by MM shall comply with all applicable laws
and regulations of the health authorities in each country in the
Territory.
3.03 MM's Authority/Responsibility. During the term of this
Agreement, except as otherwise expressly herein provided, MM
shall have the sole right and responsibility to take such actions
with respect to the Product as would normally be done in
accordance with accepted business practices in the marketing of
nuclear imaging products and legal requirements to obtain and
maintain the authorization and/or ability to market a major
nuclear medicine product in the countries in the Territory and to
actively market the Product within such countries, including,
without limitation, the following:
(i) responding to product and medical complaints
relating to the Product. As called for by Section
8.01 hereof, each party shall promptly advise the
other of any such complaints which it receives
from regulators, customers or patients in the
Territory;
(ii) handling all returns of the Product. Should the
Product be returned to IMMU, IMMU shall ship
it to MM's designated facility, with any
reasonable or authorized shipping or other
documented direct cost to be paid by MM.
IMMU, at its option, may advise the customer
who made the return that the Product has been
returned to MM;
(iii)handling, in accordance with Section 8.02 hereof,
all recalls of the Product;
(iv) communicating with any governmental agencies
and satisfying their requirements regarding the
authorization and/or continued authorization to
market the Product in commercial quantities in
the Territory;
(v) handling Product distribution, inventory and
receivables; and
(vi) labeling and packaging of Product in finished
dosage units on a commercial scale for the
Territory.
3.04 Notice of Distribution Dates. MM shall notify IMMU of the
Distribution Date in each country within the Territory as soon a
practicable after the occurrence of the sale giving rise to such
Distribution Date.
3.05 Subdistributors. MM may appoint one or more of its Affiliates
or one or more Recognized Agents to act as a Subdistributor for
the Product in the Territory, provided that no such appointment
shall affect MM's duties and responsibilities hereunder. Attached
hereto as Schedule D is a list of all MM Affiliates that MM
currently contemplates will be involved in the distribution of the
Product, as well as a list of intended Recognized Agents. MM
shall have the right to appoint as a Subdistributor any of the
organizations listed on Schedule D, as the same may be amended
from time to time, provided, that MM promptly notifies IMMU
of each such proposed appointment. MM shall have the right to
amend Schedule D by notice to IMMU, provided that no such
amendment shall be effective for (30) days after the delivery of
such notice and provided, further, that if an organization which
MM seeks to add to Schedule D in any such notice is deemed by IMMU
to be a competitor of IMMU, or IMMU has any other reasonable
business objection to the inclusion of such organization on Schedule
D, IMMU will so notify MM within such thirty (30) day period and MM
shall not appoint such organization as a Subdistributor, nor shall
such organization's name be added to Schedule D. Except as provided
in this Section 3.05, MM shall not appoint any Subdistributors for
the Product. MM shall be fully responsible for, and liable to IMMU
for, the compliance by its Subdistributors with the terms and
conditions of this Agreement. The rights of all Subdistributors
shall be subordinate to and derivative of those of MM, and no
Subdistributor shall acquire, nor shall MM purport to grant to any
Subdistributor, any rights with respect to the Product, IMMU's
patents, trademarks or Confidential Information which are greater
than those of MM or extend for any term beyond the term of this
Agreement.
3.06 Sales for Export. MM shall not export the Product from the
Territory and shall use reasonable diligence to ensure that
Products sold by MM are not sold with a view to export from the
Territory. Correspondingly, IMMU shall not export the Product
into the Territory except to MM, and shall use reasonable
diligence to ensure that Products sold outside the Territory are
not sold with a view to export into the Territory.
3.07 Non Compete. During the term of this Agreement MM shall not
launch, detail, promote, advertise, distribute or sell in the
Territory a monoclonal antibody based in-vivo diagnostic
imaging product which competes with the Product for colorectal,
breast or lung cancer indications.
3.08 Minimum Marketing and Selling Efforts. Without limiting its
obligations under Section 3.01 above, with respect to each calendar
year of the term of this Agreement MM shall at a minimum expend, in
accordance with standard cost accounting, the amounts specified in
Schedule B for promotion,marketing and selling activities
exclusively relating to the Product,training relating exclusively
to the Product, regulatory authorization and compliance efforts
relating exclusively to the Product, and other miscellaneous efforts
relating exclusively to the distribution and sale of the Product.
MM shall deliver to IMMU a certificate within forty-five (45) days
after each calendar year during the term of this Agreement setting
forth in reasonable detail the actual amounts actually expended by
MM for promotion, marketing, selling, training, regulatory
authorization and compliance, and other miscellaneous expenditures
relating to the Product during such period.
3.09 Office Space. During the term of this Agreement, at IMMU's
request from time to time, MM shall make available to IMMU at
no cost to IMMU office space at its offices in Hennef, Germany
(consisting of space reasonably adequate for at least two
employees), together with related secretarial and office support,
to facilitate the performance by employees of IMMU of their
responsibilities under this Agreement.
ARTICLE IV
PRODUCT REGISTRATIONS; COUNTRY PRICING
4.01 IMMU Registration Activities. IMMU shall use all reasonable
diligence in pursuing the processing of submissions necessary to
obtain regulatory approval of the Product by the Committee for
Proprietary Medicinal Products ("CPMP") for use as an in vivo
colorectal cancer diagnostic imaging agent. IMMU shall make
available to MM all such submissions and all data included to
support such submissions necessary for MM to perform its
obligations under this Agreement, and, through its Coordinator,
shall keep MM fully apprised of the status of its registration
efforts with respect to the Product with the CPMP, all to
facilitate MM's ability to meet its undertaking under Section 4.02
hereof.
4.02 MM Registration Activities. MM shall apply for and use all
reasonable diligence in obtaining governmental registrations and
other licenses and permits necessary for the importation into, and
the promotion, marketing, sale and distribution of the Product as
an in vivo colorectal cancer diagnostic imaging agent in each of
the individual countries within the Territory. Given the data and
submissions provided to it in English by IMMU, MM shall put
such submissions in an appropriate format for application to each
specific country. All such registrations, permits and licenses
shall be obtained in the name of IMMU, with MM named therein
as the distributor in the Territory. MM shall provide IMMU
promptly with copies of all correspondence and documentation
in connection with obtaining such registrations, licenses and
permits. MM will provide IMMU with a minimum of three (3)
written regulatory status updates each calendar year of the term
of the Agreement. IMMU shall be responsible for the payment
of all product registration fees, provided, that through the
Coordinating Committee the parties will weigh the costs of such
registration fees in particular countries against the market
opportunities in such countries, and IMMU shall not be required
to pay a registration fee in any country in which it believes that
the market potential is inadequate to justify the payment of
registration fee.
4.03 Regulatory Changes. Each party shall promptly advise the other
party of any known new instructions or specifications relating to
the Product required by the health regulatory authorities of any
country within the Territory, and the parties shall confer with
respect to the best mode of compliance with such new
requirements.
4.04 Clinical Studies. To the extent required in connection with the
registration of the Product for use as an in vivo colorectal cancer
diagnostic imaging agent in a specific country within the
Territory, the parties shall cooperate to develop, monitor and
analyze such additional clinical studies as may be so required.
The nature and scope of such studies, and the sharing of the costs
of such studies, shall be determined by good faith negotiations
between the parties, and the conduct of such studies shall be
coordinated through the Coordinating Committee. IMMU shall
supply MM at no cost to MM with Product for all such clinical
studies approved by the Coordinating Committee, provided,
however, that Product supplied at no cost shall be taken into
consideration in the cost sharing arrangements relating to such
studies. Nothing herein contained shall be construed to require
MM to contribute to the cost of any Phase II or Phase III clinical
trials with respect to the Product.
4.05 Breast and Lung Cancer Indications. The Coordinating
Committee will develop, and in good faith seek to agree upon, a
regulatory strategy for the Territory for the breast and lung
cancer diagnostic imaging indications of the Product. The costs
of implementing any clinical studies component of such
regulatory strategy shall be shared by IMMU and MM, as
determined in good faith negotiations between the parties.
Nothing herein contained shall be construed to require MM to
contribute to the cost of any Phase II or Phase III clinical trials
with respect to the Product. If further research indicates that
either or both of the lung and breast cancer indications are
unlikely to meet the objectives of the regulatory strategy
developed by the Coordinating Committee, the parties will
execute an amendment to this Agreement removing all
obligations on the part of MM to market or sell the Product for
such indications and causing all rights in respect of such
indications to revert to IMMU. Any expenses which shall have
accrued prior to the date of such amendment shall continue to be
borne by the parties in the proportions, or under the allocation
methodology, established by the Coordinating Committee.
4.06 Country Pricing. As to each country within the Territory, MM
shall make all required filings and conduct all necessary pricing
negotiations with the appropriate health authorities to establish
the pricing and reimbursement for the Product in such country.
In such activities, MM shall seek to obtain the most favorable
pricing and reimbursement rates, with the same diligence as it
applies to products of its own innovation. In addition, through
the Coordinating Committee, MM shall consult with IMMU
regarding pricing and reimbursement strategies and keep IMMU
fully apprised of the status of pricing negotiations with
regulatory authorities; provided, however, that MM shall have
the sole authority to agree upon such pricing and reimbursement
with such authorities in each country as, in its discretion, it
determines to be appropriate.
ARTICLE 5
COORDINATING COMMITTEE AND MARKETING PLANS
5.01 Coordinators. The parties shall each appoint one individual
("Coordinator ") who shall be the principal representative of such
party with respect to all matters arising under this Agreement and
who shall be responsible to coordinate communications from the
other party to and within his or her respective organization. Each
party will notify the other as to the name of the individual so
appointed. Each party may replace its Coordinator at any time,
upon notice to the other party. The Coordinators will confer in
person at IMMU's offices or at another location agreeable to
IMMU, from time to time, but no less than quarterly to discuss
and to coordinate the effective performance of the terms of this
Agreement. Among their other functions, the Coordinators will
be responsible to discuss and coordinate the exchange and
development of information and data to obtain and maintain
regulatory approvals of the Product in each of the countries
within the Territory and the strategies and programs that should
be developed to most effectively and efficiently obtain such
approvals. The Coordinators shall also exchange such
information (other than information obtained under an obligation
of confidentiality from a third party) as either party has obtained
relevant to the marketing and selling of the Product as may be
useful to the other party in its marketing efforts.
5.02 Coordinating Committee. The Coordinators shall establish a
committee ("Coordinating Committee") consisting of three
representatives from each party (comprising, in each case, the
Coordinator for such party, one regulatory affairs officer and one
additional senior executive) to act as a forum (i) to periodically
review the progress that has been made in the regulatory
approval of the Product and the marketing of the Product, (ii) to
discuss the strategic and tactical plans for marketing of the
Product in the Territory and the strategies and programs that
should be developed to maximize sales of the Product, (iii) to
make the determinations called for by Sections 4.04 and 4.05 and
(iv) in which each of the parties will in good faith seek to resolve
issues or disagreements under, or regarding the interpretation of,
this Agreement. Any individuals selected by a party as
representatives on such Committee may be changed at any time
by such party upon notice to the other party. The Coordinating
Committee shall meet periodically as reasonably requested by
either Coordinator, but in any event no less than semi-annually
within each calendar year of the term of this Agreement.
Meetings of the Coordinating Committee shall take place,
alternately, at the principal offices of each party or by means of
video conferencing equipment. No meeting of the Coordinating
Committee shall, for purposes of this Agreement, be validly
constituted unless at least two members representing each party
shall be in attendance (a quorum of the Committee), and no
action shall be taken or deemed validly taken by the Committee
unless such action shall have been approved by unanimous vote
of the members of the Committee participating at a meeting at
which a quorum is present. All actions validly taken by the
Committee shall be duly recorded in minutes of the Committee
prepared by a member of the Committee selected for that
purpose at any given meeting, shall be furnished to each party by
its respective Coordinator and shall be retained by each party as
part of its records of actions taken with respect to this
Agreement. To the extent that the Committee is deadlocked on
any matter brought before the Committee, the Committee shall
refer such matter to the Chief Executive Officers of the parties
who shall in good faith seek to resolve the dispute. Each party
shall bear its own cost incurred in participation in the
Coordinating Committee.
5.03 Marketing Plans; Sales Forecasts. Within thirty (30) days after
the Effective Date, and thereafter no later than March 1 of each
fiscal year of MM occurring during the term of the Agreement,
MM shall present its proposed marketing plan for the
forthcoming fiscal year (July 1 to June 30), including planned
pre-launch and launch activities, detailing, promotion and
marketing strategies relating to the Product for each of the
countries within the Territory and estimates of the costs and
expenses to implement such proposed marketing plan. Such
proposed marketing plan shall also include sales forecasts with
respect to each of the countries in the Territory for such
forthcoming fiscal year. The Coordinating Committee shall
review and discuss such proposed marketing plan and sales
forecasts at a meeting convened within thirty (30) days after
delivery of such plan and forecasts, and MM shall in good faith
take into account changes to such proposed marketing plan
recommended by the Coordinating Committee representatives of
IMMU. Based upon such review and recommendations, within
thirty (30) days after such Coordinating Committee meeting and
in any event, as to plans for all years after 1995, no later than
June 1 of each fiscal year of MM during the term of this
Agreement, MM shall deliver to IMMU its final marketing plan
for the forthcoming fiscal year (each an "Annual Marketing
Plan"). IMMU hereby acknowledges that any such Annual
Marketing Plan only represents MM's best estimate of its plans
and performance for the forthcoming fiscal year and does not
represent any performance guarantee on the part of MM. At
each subsequent meeting of the Coordinating Committee, MM
shall present a report of its fulfillment of the objectives of the
then current Annual Marketing Plan.
5.04 IMMU Marketing Right's. IMMU shall have the right, in its sole
discretion, to supplement MM's marketing and selling effort with
respect to the promotion of the Product in the Territory by
making expenditures of up to * in any twelve month
period. Prior to any exercise of such right, IMMU shall give
notice thereof to MM, either through a presentation at a meeting
of the Coordinating Committee or through communication
between the Coordinators, and such notice shall specify in
reasonable detail the activities which IMMU intends to undertake
and the countries within the Territory in which it intends to
undertake such efforts. IMMU shall deliver to MM a certificate
on a quarterly basis setting forth in reasonable detail the amounts
actually expended or incurred. If during either of the two
successive twelve month periods commencing with the first day
of the calendar quarter following the expenditure by IMMU of
amounts in respect of such supplemental marketing, MM's actual
Net Sales exceed MM's sales forecast as set forth in Schedule C
hereto (appropriately prorated to the extent any such twelve
month period covers more than one calendar year), MM shall
reimburse IMMU for such supplemental marketing expenses by
paying IMMU an amount equal to the lesser of:
a) * of MM's gross margin on such excess
sales (being the difference between (x) the Net Selling
Price Per Vial times the number of excess vials sold and
(y) MM's purchase price to IMMU for such excess vials), or
b) the amount actually expended or incurred by IMMU for
such supplemental marketing.
MM shall make such reimbursement within sixty (60) days
following the end of any such twelve month period.
5.05 Sampling. To achieve the objectives of this Agreement, both
parties recognize that, to the extent allowable by law, it may be
necessary to distribute a nominal quantity of the Product free of
charge as samples to health care personnel and the trade on an
ongoing basis ("Sampling Program"). For any such Sampling
Program, the Coordinating Committee, from time to time, shall
establish a reasonable sampling strategy, setting forth a sampling
period, the number of samples to be distributed during such
sampling period and the schedule for delivery of samples.
IMMU shall provide MM at no cost to MM for use in the
Sampling Program: (i) 5% of MM's forecasted sales for the first
two years of the term of this Agreement, and (ii) a reasonable
quantity thereafter as agreed to by the Coordinating Committee.
In addition, IMMU shall provide MM at no cost samples for
quality control and regulatory testing purposes.
ARTICLE 6
SUPPLY
6.01 Exclusive Supply; Requirements. IMMU will sell to MM and
MM will purchase from IMMU all of MM's requirements of the
Product for sale in the Territory. MM shall purchase such
amounts and maintain such inventory of the Product as shall
enable it to make prompt and timely delivery of the Product to
customers in the Territory.
6.02 IMMU's Supply Efforts. IMMU shall use its best efforts to
manufacture or otherwise supply sufficient quantities of the Bulk
Vialed Product to MM, for all commercial purposes in the
Territory.
6.03 Finished Dose Packaging. MM will, at its own expense, label
and package the Finished Product (including the preparation and
insertion of appropriate package inserts) for distribution and sale
in each country in the Territory. All such packaging, labeling
and package insert materials prepared by MM shall comply with
all applicable laws, regulations and guidelines of the health
authorities in each country in the Territory. MM shall bear any
and all costs and expenses associated with labeling changes
required by law.
6.04 Purchase Requirements MM shall provide IMMU at least three
(3) months before the beginning of each fiscal year with a
forecast of MM's total requirements for the Product in the
upcoming fiscal year, which forecast shall be updated quarterly.
In the case of the first fiscal year commencing after the Effective
Date, such forecast shall set forth the requirements for the period
between the anticipated First Distribution Date and the end of
such fiscal year. MM shall use its best efforts to make all
forecasts and estimates required hereunder to be reasonably
accurate predictions of the amount of Product MM will actually
require for the Territory for the relevant period. Except for the
first order for delivery of Product for which a written order will
be delivered to IMMU by MM within one (1) month after receipt
of the first governmental approval in the Territory to market the
Product, the forecast for the most current three (3) month period
shall constitute a firm order ("Firm Order Forecast") which (a)
MM shall deliver to IMMU no later than 90 days prior to the
commencement of each calendar quarter; (b) shall state in detail
the quantities of Product ordered, dates for delivery of the
Product and reasonable instructions for shipping; and (c) shall be
binding on both parties regarding the amount of Product to be
purchased. The forecast for the remaining nine month period
shall be for planning purposes only and shall not constitute a
commitment to purchase or supply. If the Firm Order Forecast
is the same as or less than the most recent previous forecast or if
it does not exceed the most recent previous forecast by more than
15%, then IMMU shall confirm the Firm Order Forecast. If the
Firm Order Forecast exceeds the most recent forecast by more
than 15%, then IMMU shall endeavor to accommodate MM but
IMMU shall have no obligation to accept and confirm the excess.
6.05 Shipping Terms. All orders for the Product submitted by MM to IMMU
hereunder shall be delivered Free Carrier (Incoterms 1990) at
IMMU's manufacturing facilities nearest to the destination of
shipment. All customs, duties, costs, taxes, insurance premiums and
other expenses relating to the transportation and delivery of the
Product shall be at MM's expense. Title to, and risk of loss of
and damage to, any shipment shall pass immediately to MM when the
shipment is deposited with a common carrier for delivery. If
requested to do so by MM, IMMU shall use reasonable efforts to
assist MM in arranging any desired insurance (in amounts MM shall
reasonably determine) and transportation to destinations in the
Territory specified in writing by MM.
6.06 Acceptance. MM shall have a maximum of thirty (30) days from
the date of its receipt of any shipment of Product to test for
quality and quantity and to accept or reject such shipment. In the
event MM does not notify IMMU of acceptance or rejection
within such thirty-day period, all of the Product in such shipment
shall be deemed to be accepted. If MM believes that any
shipment of Product hereunder does not meet the specifications
warranted by IMMU as provided in Section 10.01 hereof, MM
shall so notify IMMU in writing indicating the particular lot,
time of delivery and the defective nature of the Product. If MM
notifies IMMU of any defect in a shipment of Product, IMMU
shall have the right, but not the obligation, to send one or more
quality control representatives to retest such Product in
co-operation with quality control representatives of MM. MM shall
store all shipments of the Product in accordance with storage
specifications established by IMMU. In the event of a disagreement
between MM and IMMU regarding the quality of one or more shipments
of Product, the parties shall submit samples of the shipment in
question to an independent testing laboratory (selected by mutual
agreement of MM and IMMU) to make a determination, which shall be
binding upon the parties, as to the compliance or lack of
compliance of such shipment with the specifications warranted by
IMMU. IMMU shall promptly credit MM for any defective shipments.
6.07 Conflicting Terms. This Agreement sets forth the entire
understanding between the parties relating to the subject matter
hereof and shall govern all transactions between the parties
contemplated hereby. Except for terms relating only to:
quantities, ship dates and delivery destinations, none of the terms
and conditions contained on any purchase order, invoice or
similar document shall have any effect upon or change the
provisions of this Agreement unless signed by both parties and
clearly indicating that the parties intend to vary the terms hereof.
ARTICLE 7
PRODUCT PRICING; PAYMENT
7.01 Purchase Price. MM shall purchase the Product from IMMU at
the greater of a fixed price per vial or a specified percentage of
the Net Selling Price Per Vial, with such fixed price and
specified percentage being determined by the calendar year in
which the Product is purchased from IMMU, as follows:
Year Three
Year One Year Two and thereafter
* /vial * /vial * /vial
or * of Net or * of Net or * of Net
Selling Price Selling Price Selling Price
Per Vial Per Vial Per Vial
provided, however, that Product delivered to MM for clinical
studies as contemplated by Sections 4.04 or 4.05 shall be provided
by IMMU to MM at no cost to MM, and Product delivered to MM for the
Sampling Program contemplated by Section 5.05 and for quality
control and regulatory testing shall be provided by IMMU to MM at
no cost to MM. MM shall be credited for all Product found to be
defective under the provisions of Section 6.06
7.02 Invoicing; Payment. IMMU shall invoice the Product for each
shipment at the then applicable fixed price per vial as specified
in Section 7.01 above. MM shall pay IMMU for each shipment
of Product at the invoiced price within thirty (30) days from the
receipt of such shipment.
7.03 Semi-Annual Adjustment. Within thirty (30) days after each
successive June 30 and December 31 during the term of this
Agreement, MM shall prepare and deliver to IMMU a certificate
with supporting data in reasonable detail ("Net Selling Price
Certificate"), setting forth the Net Sales during the preceding six
month period -- in the aggregate and broken down by each
country within the Territory, the number of vials sold during
such period -- in the aggregate and in each country, and the Net
Selling Price Per Vial. If the Net Selling Price Per Vial
multiplied by the applicable percentage specified in Section 7.01
for the relevant calendar year exceeds the corresponding fixed
price per vial for such year, then MM shall pay to IMMU an
amount equal to such excess multiplied by the total number of
vials sold to MM during such six month period. Such payment
shall be made by MM simultaneously with the delivery of the
Net Selling Price Certificate.
7.04 Currency. All payments by MM to IMMU under this Agreement
shall be made in U.S. Dollars and, except as otherwise expressly
provided, all references in this Agreement to dollars shall be
deemed to mean and refer to U.S. Dollars.
ARTICLE 8
COMPLAINTS/RECALLS
8.01 Complaints. To the extent that it has knowledge thereof, each
party shall promptly notify the other in writing of any defect in,
or condition of, the Product which may cause the Product to
violate the U.S. Federal Food, Drug and Cosmetic Act or Section
352 of the U.S. Public Health Service Act or any material
regulations promulgated thereunder, or similar applicable laws
and regulations of any country in the Territory where the Product
is being sold by MM. IMMU and MM shall share with each
other all data on complaints respecting the Product, including,
but not limited to, complaints or information regarding
performance or allegations or reports of any effects on a patient
from use of such Product, as soon as such data is available.
8.02 Recall. In the event that either party has reason to believe that
one or more lots of Product should be recalled or withdrawn
from distribution, such party shall immediately notify the other
party in writing. To the extent permitted by the circumstances,
the parties, through their respective Coordinators, will confer
before initiating any recall, but the decision as to whether or not
to initiate a recall of Product in any country in the Territory shall
be MM's alone. MM shall maintain adequate sales and service
records to enable it to carry out any Product recall and to conduct
such recall. If the recall is required because of a modification of
the registrations, permits or licenses for the Product or a failure
of the Product to conform to its specifications as provided to the
health authorities in any specific country in connection with the
registration of the Product, IMMU shall reimburse MM for the
costs and expenses of such recall, and, at MM's option, IMMU
shall replace recalled Product or credit or refund the purchase
price of recalled Product. If the recall is required because of a
negligent act or omission of MM in handling, storage or
distribution of the Product, then such recall shall be conducted
by MM at its sole cost and expense and MM shall not be entitled
to any such credits, replacements or refunds from IMMU. If
such recall is required because of a joint act or omission, MM
shall conduct the recall and the parties shall negotiate in good
faith an appropriate allocation of the costs and expense of such
recall.
8.03 Regulatory Records; Adverse Reactions. Each party shall be
responsible for maintaining such records and making such
reports as may be required in connection with any regulatory
approval held by the party. Each party shall promptly inform the
other of all adverse drug experience reports and other
information relating to the safety or effectiveness of the Product
which come to its attention, in a form and within time periods
necessary to permit compliance with all applicable regulatory
requirements under FDA regulations or the law and regulations
of each of the countries within the Territory.
ARTICLE 9
PRODUCT IDENTIFICATION AND TRADEMARK
9.01 Use of IMMU Trademarks. IMMU hereby grants MM the non-exclusive
right during the term of this Agreement to use the
Immunomedics logo and the mark "Immunomedics", in addition
to its right to use the trademark CEA-Scan or such other
mark(s) as IMMU shall cause to be registered for the Product as
contemplated by Section 2.02 hereof, (collectively the "Marks")
in the Territory in connection with, and confined to the purpose
of, the sale, marketing and distribution of the Product. To the
extent permitted by applicable law in each country within the
Territory, MM shall use the Marks on labeling, packaging and
package inserts for the Product, in all of MM's promotion of the
Product and in all literature related thereto, and with the
exception of MM's corporate identification for the Product,
which shall be given no greater prominence than the Marks, MM
shall not use any other trademarks or logos on any labeling,
packaging, package inserts, literature or promotional material
relating to the Product. MM shall comply with and observe the
reasonable requirements of IMMU relating to (i) the marking of
the Product and/or its label, packaging, package insert or other
printed materials pursuant to any and all applicable patent laws
to indicate that letters patent have been applied for or granted in
one or more countries and (ii) the use of the Marks in conformity
with the trademark laws of the countries in the Territory. Prior
to its use, MM shall submit all such labeling, packaging, package
inserts, promotional material and related literature to IMMU for
its approval of the use of such Marks, which approval shall not
be unreasonably withheld by IMMU.
9.02 Ownership of Marks. MM acknowledges that the Marks are and shall
remain the property of IMMU, and MM disclaims any rights to such
Marks other than the rights granted by Section 9.01 hereof. MM
shall not use the Marks or any other IMMU trademark, trade or brand
name for any purpose other than as provided in such Section 9.01.
ARTICLE 10
WARRANTIES AND INDEMNIFICATION
10.01 Manufacturing Warranty. IMMU warrants that (i) the Product
shall be produced in accordance with FDA's current good
manufacturing practices, (ii) when shipped to MM the Product
shall not be adulterated or misbranded and (iii) the Product shall
be otherwise manufactured in accordance with written
manufacturing procedures and finished product specifications
which will meet the requirements set forth in the governmental
submissions filed by IMMU, or approved by IMMU for filing,
with health regulatory authorities in the Territory. IMMU HEREBY
DISCLAIMS ALL OTHER WARRANTIES REGARDING THE PRODUCT, EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE. Except as otherwise expressly provided in this
Agreement, the liability of IMMU for a breach of the foregoing
warranty shall be limited to the specific shipments of the Product
as to which a claim is made, and IMMU shall not be liable for
incidental or consequential damages, loss of profit, or loss of use.
10.02 Corporate Authority. Each party warrants and represents to the
other that it has the full right and authority to enter into this
Agreement, that all corporate action necessary to authorize the
execution and delivery of this Agreement by such party has been
duly and properly taken, and that it is not aware of any
impediment that would inhibit its ability to perform its
obligations under this Agreement.
10.03 MM Indemnification. With respect to Product sold by MM in
the Territory, MM shall defend IMMU, its agents, directors,
officers and employees at its cost and expense, and will
indemnify and hold harmless IMMU, its agents, directors,
officers, and employees from and against any and all claims for
losses, costs, damages, fees or expenses arising out of or in
connection with the commercialization, marketing, use or sale of
the Product in the Territory, including but not limited to, any
actual or alleged injury, damage, death or other consequence
occurring to any person as a result, directly or indirectly, of the
possession, use or consumption of the Product, whether claimed
by reason of breach of warranty, negligence, product defect or
otherwise and regardless of the form in which any such claim is
made, provided that the foregoing indemnity shall not apply to
the extent that any actual or alleged injury, damage, death or
other consequence occurring to any person is specifically and
proximately due a breach by IMMU of the warranty set forth in
Section 10.01 above.
10.04 IMMU Indemnification. IMMU shall defend MM, its agents,
directors, officers and employees at its cost and expense, and will
indemnify and hold harmless MM, its agents, directors, officers
and employees, from and against any and all losses, costs,
damages, fees or expenses arising out of a breach by IMMU of
the warranty set forth in Section 10.01 above, including, but not
limited to, any actual or alleged injury, damage, death or other
consequence occurring to any person as a result, directly or
indirectly, of the possession, use or consumption of any Product,
whether claimed by reason of negligence, product defect or
otherwise, and regardless of the form in which any such claim is
made.
10.05 Indemnification Procedures. (a) Promptly after the receipt by
any party hereto of notice under Section 10.03 or 10.04 of (A)
any claim or (B) the commencement of any action or proceeding,
such party (the "Aggrieved Party") will, if a claim with respect
thereto is to be made against any party obligated to provide
indemnification (the "Indemnifying Party") pursuant to such
Sections 10.03 and 10.04, give such Indemnifying Party written
notice of such claim or the commencement of such action or
proceeding and shall permit the Indemnifying Party to assume
the defense of any such claim or any litigation resulting from
such claim, and, upon such assumption, shall cooperate fully
with the Indemnifying Party in the conduct of such defense.
Failure by the Indemnifying Party to notify the Aggrieved Party
of its election to defend any such action within a reasonable time,
but in no event more than fifteen days after notice thereof shall
have been given to the Indemnifying Party, shall be deemed a
waiver by the Indemnifying Party of its right to defend such
action. If the Indemnifying Party assumes the defense of any
such claim or litigation resulting therefrom, the obligations of the
Indemnifying Party as to such claim shall be limited to taking all
steps necessary in the defense or settlement of such claim or
litigation resulting therefrom and to holding the Aggrieved Party
harmless from and against any and all losses, damages and
liabilities caused by or arising out of any settlement approved by
the Indemnifying Party or any judgment in connection with such
claim or litigation resulting therefrom. The Aggrieved Party may
participate, at its expense, in the defense of such claim or
litigation provided that the Indemnifying Party shall direct and
control the defense of such claim or litigation. The Indemnifying
Party shall not, in the defense of such claim or any litigation
resulting therefrom, consent to entry of any judgment, except
with the written consent of the Aggrieved Party, or enter into any
settlement, except with the written consent o the Aggrieved
Party, which does not include as an unconditional term thereof
the giving by the claimant or the plaintiff to the Aggrieved Party
of a release from all liability in respect of such claim or
litigation.
(b) If the Indemnifying Party shall not assume the defense of
any such claim or litigation resulting therefrom, the Aggrieved
Party may defend against such claim or litigation in such manner
as it may deem appropriate and, unless the Indemnifying Party
shall deposit with the Aggrieved Party a sum equivalent to the
total amount demanded in such claim or litigation, or shall
deliver to the Aggrieved Party a surety bond in form and
substance reasonably satisfactory to the Aggrieved Party, the
Aggrieved Party may settle such claim or litigation on such
terms as it may deem appropriate, and the Indemnifying Party
shall promptly reimburse the Aggrieved Party for the amount of
all reasonable expenses, legal or otherwise, incurred by the
Aggrieved Party in connection with the defense against or
settlement of such claims or litigation. If no settlement of such
claim or litigation is made, the Indemnifying Party shall
promptly reimburse the Aggrieved Party for the amount of any
judgment rendered with respect to such claim or in such
litigation and of all reasonable expenses, legal or otherwise,
incurred by the Aggrieved Party in the defense against such
claim or litigation.
10.06 (a) Insurance Coverage. Each party shall purchase and maintain
insurance at its own expense to cover liabilities that it may incur
in the testing, manufacture, distribution, sale or use of the
Product. Each party agrees to provide the minimum amounts and
types of insurance, to protect its interests, as follows, which
may include self insurance :
(i) Commercial General Liability Insurance with the following
minimum limits of liability:
General Aggregate $ *
Personal and Advertising Injury *
Each Occurrence *
(ii) Insurance covering Product Liability/Clinical Studies Liability
in amounts not less than:
General Aggregate $ *
Each Occurrence *
In the event that any such policies are on a claims made basis,
coverage shall be maintained for a period of at least five years
after the termination of this Agreement. Each party shall furnish
to the other certificates of insurance, evidencing such insurance
and naming the other party as a co-insured, except for limits
covered under the self-insurance programs of either party.
(b) MM shall, in addition, include IMMU as an additional named
insured on its policies of product liability insurance covering the
Product and on its general comprehensive liability insurance
covering the sale and distribution of the Product in the Territory,
cause such policies to provide that they shall not be cancelled by
the insurer without thirty (30) days prior notice therof to IMMU,
and, upon IMMU's request, MM shall furnish IMMU with a
certificate of insurance evidencing such coverage.
ARTICLE 11
PATENT AND TRADEMARK INFRINGEMENT
11.01 Patents. IMMU warrants and represents that is has no
knowledge of the existence of any patent in a country of the
Territory owned or controlled by anyone other than IMMU,
which covers the Product or would prevent MM or IMMU from
making, using or selling the Product in the Territory or would
prevent MM and IMMU from promoting or detailing the Product
in the Territory.
11.02 Infringement of IMMU Rights. Each party shall promptly notify
the other upon its becoming aware of any actual or suspected
infringement by a third party of a patent or trademark owned by
IMMU covering or identifying the Product in the Territory.
IMMU and MM shall confer on the desirability of initiating
action against such third party and, if warranted in the reasonable
opinion of IMMU, IMMU shall promptly take such action,
including the initiation of legal proceedings, as is required to
restrain or otherwise prevent such infringement. IMMU shall
have the right to retain any and all amounts recovered from such
third party as a result of any action which it may bring.
11.03 Infringement of Third Party Rights. In the event that a third
party at any time provides written notice of a claim to, or brings
an action, suit or proceeding against, either party or any of their
respective Affiliates, claiming infringement of its patent or
trademark rights or unauthorized use or misappropriation of its
technology, based upon an assertion or claim arising out of the
manufacture, use and/or sale of Product in the Territory, such
party shall promptly notify the other party of the claim or the
commencement of such action, suit or processing, enclosing a
copy of the claims and/or all papers served. Each party will
make available to the other party its advice and counsel
regarding the technical merits of any such claim. IMMU shall
undertake, at its expense, the defense of any such action, suit or
proceeding and shall manage and control the defense of such
action and its settlement. If as a result of any such action, suit
or proceeding, MM or any Affiliate, in order to sell the Product in
any country in the Territory, becomes obligated under an
agreement or settlement, to make any payments to one or more
parties to obtain a license or similar right in the absence of which
the Product could not lawfully be made, used or sold in a country
in the Territory, then from and after the date of imposition of
such payments: (i) to the extent that the purchase price of the
Product to MM under Section 7.01 is then being determined as
a percentage of the Net Selling Price Per Vial, such payments
shall be properly chargeable against the calculation of the Net
Selling Price Per Vial as calculated under Section 1.13, and (ii)
to the extent that the purchase price of the Product to MM under
Section 7.01 is then being determined only on the basis of a fixed
price per vial, * of such payments, determined
on a per vial basis, shall be properly chargeable against the
purchase price of the Product to MM.
ARTICLE 12
GROSS INEQUITIES
12.01 Gross Inequities. It is the intent of the parties hereto that
they shall mutually benefit from the terms,conditions and provisions
of this Agreement, and in the event that either party shall suffer
a gross inequity resulting from such terms, conditions or
provisions, or from a substantial change in circumstances or
conditions, the parties shall negotiate in good faith to resolve or
remove such inequity. It is mutually agreed, however, that
nothing herein shall be construed to relieve either party of any of
its obligations under this Agreement. Other than as to such gross
inequities, neither party shall assert or cause to be asserted in
any suit, action, proceeding or other adjudication that any of the
terms, conditions, or provisions of this Agreement are or will be
unenforceable, unjust, unreasonable, preferential or prejudicial,
or otherwise in violation of any provision of any statute or
applicable rule thereof.
ARTICLE 13
TERM AND TERMINATION
13.01 Term. This Agreement shall commence on the Effective Date
and, except as provided below in this Article 13, shall extend
through the fifth anniversary of the First Distribution Date (the
"Initial Term"). Thereafter, the Agreement may be renewed for
successive two (2) year periods at the sole discretion of IMMU,
by notice given to MM at least one hundred eighty (180) days
prior to the beginning of any such additional period. (The Initial
Term and all such successive periods, if any, shall collectively be
known as the "term of this Agreement")
13.02 Mutual Termination Rights. Either party shall have the right
to terminate this Agreement:
(i) upon sixty (60) days prior notice to the other in
the event that the other shall commit any material breach of its
obligations hereunder and shall fail to remedy the same within
forty-five (45) after being called upon in writing to do so; or
(ii) to the extent permitted by law, upon notice to the
other in the event the other party suspends its business, becomes
insolvent, fails generally to pay its debts as they mature, files a
voluntary petition or any answer admitting the material
allegations of, or consents to, an involuntary petition pursuant to
or purporting to be pursuant to any reorganization or insolvency
law of any jurisdiction, makes an assignment for the benefit of
creditors, or applies for or consents to the appointment of a
receiver or trustee of a substantial party of its property; or
(iii) following a "change of control" of the other party,
if immediately following such change of control the Person or
Persons acquiring control of such other party are competitors of
the terminating party. For purposes of this clause, a "competitor"
means any Person whose product line includes an in vivo
diagnostic imaging agent for colorectal, breast or lung cancer
indications, and a "change of control" shall be deemed to have
occurred with respect to a party to this Agreement if (a) a Person
or group of Persons acting in concert acquires more than 50% of
the voting power of all outstanding voting securities of such
party , (b) such party engages in a corporate transaction
(including a merger, consolidation, sale of assets or other
corporate reorganization) which upon its consummation results
in the shareholders of such party immediately prior to such
transaction owning less than 50% of the outstanding stock of the
resulting entity, or (c) as to MM, its ultimate corporate parent
ceases to own, directly or indirectly, at least 50% of the
outstanding common stock of MM or ceases to have the right to
designate at least one half of the board of directors of MM.
13.03 Competitive Product. In the event that MM develops another in
vivo diagnostic imaging product for colorectal, breast or lung
cancer indications which is not monoclonal based, MM shall
notify IMMU, simultaneously with its first submission of a
product registration filing in any Major Market, that such filing
has been made. After the delivery of such notice, MM shall have
the right to elect to terminate this Agreement upon twelve (12)
months prior notice, and IMMU shall have the right to elect to
terminate this Agreement upon one (1) months prior notice.
13.04 Market Diligence. Without limiting its right to termination
for material breach as contemplated by Section 13.02, IMMU shall
have the right to terminate this Agreement upon sixty (60) days
prior notice to MM if: (i) MM exercises its right under Section
2.03 to reduce the Territory with respect to any Major Market;
(ii) MM's projected unit sales of the Product as set forth in
Schedule C hereto for the calendar year 1997 is not achieved in
such year; or (iii) if MM has materially failed to fulfill the
objectives of its Annual Marketing Plan for two successive
annual periods.
13.05 Lack of Product Registration. Without limiting its right to
termination for material breach as contemplated by Section 13.02,
MM shall have the right to terminate this Agreement upon sixty (60)
days prior notice to IMMU given at any time between January 1, 1997
and February 28, 1997, if by December 31, 1996, IMMU shall not have
obtained a product registration for the marketing of the Product in
at least one country within the Territory.
13.06 (a) Rights and Obligations Upon Termination. Upon any termination
of this Agreement, MM shall promptly return to IMMU or its
designee or otherwise cause to be transferred to IMMU all
product registrations, permits and licenses and files related to
such governmental authorizations relating to the Product and all
Confidential Information of IMMU, and MM shall have no
further rights thereto. To the extent transfer or assignment of
approvals, licenses or rights is not permitted under local law,
MM shall cooperate in the cancellation of the same and in the
reissuance thereof to IMMU or its designee. MM shall not after
the termination of this Agreement use in the Territory any name
or mark confusingly similar to any Mark of IMMU's in
connection with the sale of any product by MM.
(b) Termination of this Agreement in whole or in part shall not
relieve the parties of any amounts owing between them, nor shall
it relieve the parties of their obligations with respect to the
Product distributed hereunder, or with respect to limiting
disclosure and use of Confidential Information. Upon
termination of this Agreement: (i) as a result of IMMU's breach,
MM shall have the right either to sell its then inventory of the
Product during such period as may be required to liquidate such
inventory in an orderly manner or to return such inventory to
IMMU for a price per vial equal to the greater of the most recent
Net Selling Price Per Vial or the landed cost to MM of such vial,
and (ii) for any reason other than IMMU's breach, IMMU shall
have the right to repurchase all or any portion of MM's inventory
of Product, at MM's landed cost thereof; and with respect to any
quantities not repurchased by IMMU, MM shall have the right
to sell Product from such quantities, in the ordinary course of
business, for a period of three (3) months following termination.
The provisions of Article 10 shall survive any termination of this
Agreement.
ARTICLE 14
CONFIDENTIALITY
14.01 Confidentiality. For a period of ten (10) years from the
Effective Date of this Agreement or five (5) years from the
termination hereof, whichever occurs later:
(i) each party shall refrain from the use of
Confidential Information furnished by the other party for any
purpose inconsistent with this Agreement; and
(ii) each party shall treat Confidential Information
furnished by the other party as if it were its own proprietary
information and shall not disclose it to any third party other than
its Affiliates or consultants without the prior written consent of
the other party who furnished such information; provided,
however, that such Confidential Information may be disclosed if
in the reasonable opinion of recipient's counsel, such disclosure is
necessary to comply with the requirements of any law, governmental
order (including a court order), regulation or Internal Revenue
Service request. Recipient shall notify and consult with the
disclosing party prior to such disclosure of information.
14.02 Advertising and Publicity. Subject to Section 14.03 and except
for such disclosures as are deemed necessary in IMMU's or
MM's, as the case may be, reasonable judgment to comply with
applicable law (such as, by way of example but not limitation,
the securities laws of the United States), neither IMMU nor MM
nor anyone acting on its behalf will make any publicly
disseminated oral or written disclosure relating or referring to,
or use any advertising or publicity which relates or makes reference
to, the other party, this Agreement or the terms hereof, without
in each case having received the other party's prior approval
(which approval will not be unreasonably withheld or delayed);
each party will respond promptly to a disclosure request, but in
any event not later than ten (10) business days from receipt of
such a request. The foregoing restriction shall not apply to any
information which is contained in any previously issued press
release or other disclosure that has been approved by the other
party or that is otherwise indicated on Product labels, packaging,
brochures or similar promotional material.
14.03 Disclosure Required by Law. In the event that IMMU or MM
shall be required to make disclosure of the other's Confidential
Information as a result of the issuance of a court order or other
government process, the party subject to such requirement
promptly, but in not event more than forty-eight (48) hours after
learning of such court order or other government process, shall
notify the other party and, at the other party's expense, the party
subject to such requirements shall: (a) take all reasonably
necessary steps requested by the other party to defend against the
enforcement of such court order or other government process,
and, (b) permit the other party to intervene and participate with
counsel of its choice in any proceeding relating to the
enforcement thereof.
14.04 Manuscripts. MM shall use its best efforts to submit to IMMU
for review at least thirty (30) days prior to submission for
publication all manuscripts relating to the Product, its use, or
the result of clinical trials written by MM's employees or by
collaborators or clinical investigators participating in studies
funded in whole or in party by MM. If IMMU has not
disapproved of the publication of the manuscript within thirty
(30) days after receipt, the author may submit the manuscript for
publication, and IMMU shall have no further right to comment.
Approval of any such manuscript shall not be reasonably
withheld or delayed. However, IMMU reserves the right to have
deleted from the manuscript any material which may be
reasonably considered Confidential Information.
ARTICLE 15
MISCELLANEOUS
15.01 Governing Law; Choice of Forum. The validity of this
Agreement, the construction and enforcement of its terms, and the
interpretation of the rights and duties of the parties hereunder
will be governed by the laws of the State of New York, USA,
excluding those laws that relate to the choice of law and
excluding the United Nations Convention on Contracts for the
International Sale of Goods. The exclusive jurisdiction and
venue for any disputes arising out of or in connection with this
Agreement will be an appropriate federal court located in the
Southern District of NewYork, and each party hereby consents
to personal jurisdiction in such court and consents to service of
process by means of certified or registered mail, return receipt
requested.
15.02 Independent Contractor. MM will perform all of its activities
hereunder as an independent contractor, and nothing contained
in this Agreement shall be deemed to create any association,
partnership, joint venture, or relationship of principal and agent
between the parties to this Agreement or any of their respective
Affiliates, or to provide either party with the right, power or
authority, whether express or implied, to create any such duty or
obligation on behalf of the other party. No employee or
representative of a party shall have any authority to bind or
obligate the other party to this Agreement for any sum or in any
manner whatsoever, or to create or impose any contractual or
other liability on the other party without said party's authorized
written approval.
15.03 Accounting Audits. Each party shall maintain books of account
relating to its expenditures pursuant to this Agreement, and in the
case of MM, Gross Sales, Net Sales and Net Selling Price per
Vial in accordance with U.S. generally accepted accounting
standards with appropriate controls to insure that transactions are
properly recorded. Each party shall have the right, at it own
expense, to have an independent certified public accountant of its
own selection, reasonably acceptable to the other, examine at a
time reasonably acceptable to the other, during normal business
hours but not more than once each calendar year, the relevant
books and records of account of other, to determine whether
appropriate accounting has been made under Sections 3.08, 5.04
and Article 7 hereof hereunder. Such independent certified
accountant shall treat as confidential and shall not disclose to the
party engaging such accountant any information other than that
which is relevant to the rights of the engaging party hereunder or
the performance by the other party of its obligations hereunder.
If such independent certified public accountant shall determine
that the amounts due and owing by MM to IMMU during any
calendar year exceed amounts actually paid by five percent (5%)
or more, then MM shall, in addition to promptly paying such
shortfall, reimburse IMMU for the fees and expenses of such
accountants. In the event of a dispute between the independent
certified public accountants of MM and IMMU with respect to
any matter called for by this Agreement, the parties shall select
a third independent public accounting firm to arbitrate the
dispute, provided, that such firm shall have the authority only to
select from among the positions of the original two firms that
position which it deems most accurate. The fees of such third
firm shall be borne by the party whose position is not approved
of by such arbitrator.
15.04 Interest Due on Late Payments. If any amount payable by MM
to IMMU hereunder is not paid when due, then without limiting
any other rights which IMMU may have as a result of such late
payment, the amount unpaid shall bear interest until paid at a rate
per annum equal to the prime rate published and as changed from
time to time by Citibank, N.A. New York, New York (as
reported in The Wall Street Journal) plus one percent (1%), with
such interest to be paid on demand together with all costs
incurred by IMMU to collect the amounts due hereunder,
including but not limited to reasonable attorneys fees and
disbursements.
15.05 Taxes. Each party shall bear all taxes imposed on it as a
result of the performance by such party under this Agreement
including, but not limited to, any sales tax, any tax on or
measured by any payment required to be made hereunder, any
registration tax, or any tax imposed with respect to the granting
of licenses or other rights hereunder. The parties shall cooperate
fully with each other in obtaining and filing all requisite
certificates and documents with the appropriate authorities and
shall take such further action as may reasonably be necessary to
avoid the deduction of any withholding or similar taxes from any
remittance of funds by MM to IMMU hereunder.
15.06 Employees. Neither party shall have any responsibility for the
hiring, firing or compensation of the other party's employees or
for any employee benefits of the other party's employees.
15.07 Assignment. This Agreement shall be binding upon, and shall
inure to the benefit of successors to a party hereto, but shall not
otherwise be assignable without the prior written consent of both
parties, except to the successor or assignee of all or a majority
interest in either party's business relating to the licensed
Product. In the event all or a majority interest is assigned or
transferred, each party shall notify the other prior to such
assignment or transfer.
15.08 Notices. Any notice required or permitted to be made or given
hereunder shall (except as otherwise expressly provided herein)
be in writing and shall be made or given to the other party by
personal in-hand delivery; by telecopier or telex communication;
by first-class mail, postage prepaid; or by air courier to the
mailing or telecopier or telex numbers set forth below:
Mallinckrodt Medical B.V.
Westerduinweg 3
PO Box 3
1755 ZG Petten
Holland
Attention: General Manager, Vice President
Telecopier No. (011) 31-2246-3566
Immunomedics, Inc.
300 American Road
Morris Plains, NJ 07950
Attention: Chief Executive Officer
Telecopier No. (201) 605-8282
or to such other address or telecopier or telex numbers as either
party shall designate by notice, similarly given, to the other
party. Notices shall be deemed to have been sufficiently made
or given: (i) if by personal in-hand delivery, or by telecopier or
telex with confirmed transmissions, when performed; (ii) if
mailed, ten (10) days after being deposited in the mail, postage
prepaid; or (iii) by air courier, three (3) days after delivery to
the air courier company.
15.09 Force Majeure. In the event that either party is prevented
from performing or is unable to perform any of its obligations under
this Agreement due to any act of God, fire, casualty, flood, war,
strike, lockout, failure of public utilities, injunction or any act,
exercise, assertion or requirement of governmental authority,
including any governmental law, order regulation permanently
or temporarily prohibiting or reducing the level of research,
development or production work hereunder or the manufacture,
use or sale of Product, epidemic, destruction of production
facilitates, riots, insurrection, inability to procure or use
materials, labor, equipment, transportation or energy sufficient
to meet experimentation or manufacturing needs; or any other
cause beyond the reasonable control of the party invoking this
Section 15.09 provided such party shall have used its best efforts
to avoid such occurrence; such party shall give notice to the
other party in writing promptly, and thereupon the affected
party's performance shall be excused and the time for
performance shall be extended for the period of delay or inability
to perform due to such occurrence.
15.10 Waiver. The waiver by either party of a breach or a default of
any provision of this Agreement by the other party shall not be
construed as a waiver of any succeeding breach of the same or
any other provision, nor shall and delay or omission on the part
of either party to exercise or avail itself of any right, power or
privilege that it has or may have hereunder operate as a waiver
of any right, power or privilege by such Party.
15.11 Partial Invalidity. The parties to this Agreement desire and
intend that the terms and conditions of this Agreement be
enforced to the fullest extent permissible under the laws and
public policies applied in each jurisdiction where enforcement is
sought. If any particular term or condition of this Agreement is
adjudicated , or becomes by operation of law, invalid or
unenforceable, this Agreement will be deemed amended to delete
the portion which is adjudicated, or which becomes by operation
of law, invalid or unenforceable, provided, however, that where
possible, a particular term or condition will be reduced to the
extent necessary to permit the remainder of the particular term or
condition to be enforced, the deletion or reduction to apply only
with respect to the operation of the term or condition and the
remainder of this Agreement to remain in full force and effect.
A deletion or reduction of any term or condition will apply only
with respect to the operation of that term or condition in the
particular jurisdiction in which such adjudication is made or
becomes by operation of law, invalid or unenforceable.
15.12 Captions. All captions herein are for convenience only and
shall not be interpreted as having any substantive meaning.
15.13 Integration. This Agreement constitutes the entire agreement
between the parties hereto relating to the subject matter hereof
and supersedes all prior communications and understandings,
written or oral, with respect to this subject. This Agreement may
be amended only by means of an instrument executed in writing
by properly authorized representatives of IMMU and MM.
15.14 Counterparts; English language. This Agreement may be
executed in any number of counterparts, each of which shall be
deemed an original but all of which together shall constitute one
and the same instrument. This Agreement is entered into in the
English language. In the event of any dispute concerning the
construction or meaning of this Agreement, reference shall be
made only to this Agreement as written in English and not to any
translation hereof into any other language, and this English
language version shall be controlling for all purposes.
IN WITNESS WHEREOF, Mallinckrodt Medical B.V. and
Immunomedics, Inc. have caused this Agreement to be duly executed by their
authorized representatives, in duplicate on the dates written herein below.
Attest: Mallinckrodt Medical B.V.
By ____________________________ By ____________________________
Date __________________________
Attest: Immunomedics, Inc.
By ____________________________ By ____________________________
Date __________________________
SCHEDULE A
TERRITORY
Austria
Belgium
Bulgaria
Czech Republic
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Russia
Slovakia
Spain
Sweden
Switzerland
Ukraine
United Kingdom
Other territories comprising the former Soviet Union
The term "Territory" shall be deemed to include any new or different
countries resulting from changes in the name or political composition
of the above listed countries.
SCHEDULE B
MARKETING EXPENDITURES
U.S. Dollars (in thousands)
1995 1996 1997 1998 1999
Promotion * * * * *
Marketing * * * * *
Selling * * * * *
Training * * * * *
Regulatory * * * * *
Others * * * * *
TOTAL $ * * * * *
Promotion expenditures to include, among other items, case book, oncology
update, product reprints, congresses, and computer aided education programs.
Marketing expense to comprise marketing resources (team) exclusively
allocated to CEA-Scan and expenses related thereto.
Selling expenditures to include, among other items, sales force meetings,
local symposia, and local market incentive programs, in each case relating
exclusively to CEA-Scan.
Regulatory expenses to comprise resources for registration and
pricing/reimbursement filings, including any special local market
requirements which could include specific market expertise
(i.e. clinical expert reports, etc.).
SCHEDULE C
FORECASTED UNIT SALES
FORECAST
YEAR 1995 1996 1997 1998 1999
UNITS * * * * *
SCHEDULE D
MM AFFILIATES AND RECOGNIZED AGENTS
Austria
B.S.M. Diagnostics GmbH, Wien
Belgium
Mallinckrodt Medical S.A./N.V., Brussels
Bulgaria
Electron ABT. STE., Sofia
Czech Republic
KBC Spol S.R.O., Rokycany
Denmark
Dandiag ApS, Copenhagen
Estonia
Tamro Cooperation, Vantaa
Finland
Tamro Cooperation, Vantaa
France
Mallinckrodt Medical S. A., Evry Lisses
Germany
Mallinckrodt Radiopharma GmbH, Hennef
Greece
Biomedica Ltd., Athens
Hungary
FZINTA Trading Co., Ltd., Budapest
Ireland
Perlamar Ltd., Dublin
Italy
Byk-Gulden SpA, Milan
Latvia
No official agent
Lithuania
No official agent
Luxembourg
Mallinckrodt Medical S.A./N.V., Brussels
Netherlands
Mallinckrodt Medical B.V., Petten
Norway
Laboral AS, Oslo
Poland
No official agent
Portugal
Mallinckrodt Iberica S.A., Madrid
Romania
Rombel medical S.A., Bucharest
Russia
No official agent
Slovak Republic
Izomedact, Bratislava
Spain
Mallinckrodt Iberica S.A., Madrid
Sweden
Diagnostic Imaging, Linkoping
Switzerland
Mallinckrodt Medical AG, Zurich
Ukraine
No official agent
United Kingdom
Mallinckrodt Medical (UK) Ltd., Northhamton