UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q/A
(Amendment No. 1)
[X] Quarterly Report Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934.
For the period ended March 31, 1996
Commission File Number: 0-12104
IMMUNOMEDICS, INC.
(Exact name of registrant as specified in its charter)
Delaware 61-1009366
(State or other jurisdiction of (IRS Employer Identification No.)
incorporation or organization)
300 American Road, Morris Plains, New Jersey 07950
(Address of principal executive offices) (Zip code)
(201) 605-8200
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15 (d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period
that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
[X] Yes [ ] No
Indicate the number of shares outstanding of each of the issuer's classes of
common stock as of the latest practicable date.
As of May 8, 1996, there were 34,064,014 shares of the registrant's
common stock outstanding.
<PAGE>
PART II - Other Information:
Item 6. Exhibits and reports on Form 8-K
(a) Exhibits
10.22 Distribution and Marketing Agreement, dated as of
April 4, 1996, between the Registrant and
Mallinckrodt Medical, Inc.
* Confidential portions have been omitted and
filed separately with the Commission.
(b) Reports on Form 8-K
The Company did not file a Current Report on Form 8-K during
the three-month period ended March 31, 1996.
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
IMMUNOMEDICS, INC.
(Registrant)
DATE: July 19, 1996 /s/ David M. Goldenberg
_______________________
David M. Goldenberg,
Chairman of the Board,
Chief Executive Officer, and Treasurer
(Principal Executive Officer
and Principal Accounting Officer)
Execution Copy
* Confidential portions omitted and filed separately with the Commission.
DISTRIBUTION AND MARKETING AGREEMENT
Dated as of April 4, 1996
Between
IMMUNOMEDICS, INC.
and
MALLINCKRODT MEDICAL, INC.
<PAGE>
TABLE OF CONTENTS
ARTICLE 1 DEFINITIONS. . . . . . . . . . . . . .2
1.01 "Affiliate . . . . . . . . . . . . . . . .2
1.02 "Agreement . . . . . . . . . . . . . . . .2
1.03 "Confidential Information. . . . . . . . .2
1.04 "Coordinator . . . . . . . . . . . . . . .3
1.05 "Effective Date. . . . . . . . . . . . . .3
1.06 "FDA . . . . . . . . . . . . . . . . . . .3
1.07 "Gross Sales . . . . . . . . . . . . . . .3
1.08 "Meeting . . . . . . . . . . . . . . . . .3
1.09 "IMMU Patents. . . . . . . . . . . . . . .3
1.10 "Net Sales . . . . . . . . . . . . . . . .3
1.11 "Person. . . . . . . . . . . . . . . . . .3
1.12 "Product . . . . . . . . . . . . . . . . .3
1.13 "Sub-Consignee . . . . . . . . . . . . . .3
1.14 "Territory . . . . . . . . . . . . . . . .4
ARTICLE 2 APPOINTMENT. . . . . . . . . . . . . .4
2.01 Appointment. . . . . . . . . . . . . . . .4
2.02 Title and Risk of Loss . . . . . . . . . .4
2.03 Appointment of Sub-Consignee . . . . . . .4
2.04 Reservation of Rights. . . . . . . . . . .5
ARTICLE 3 ACCEPTANCE; MARKETING OBLIGATIONS. . .5
3.01 Acceptance . . . . . . . . . . . . . . . .5
3.02 Promotion Standard . . . . . . . . . . . .6
3.03 MM's Authority/Responsibility. . . . . . .6
3.04 Restricted List. . . . . . . . . . . . . .7
3.05 Sales for Export . . . . . . . . . . . . .7
3.06 Non Compete. . . . . . . . . . . . . . . .7
3.07 Minimum Marketing and Selling Efforts. . .8
3.08 PL Fee . . . . . . . . . . . . . . . . . .8
ARTICLE 4 PRODUCT REGISTRATIONS. . . . . . . . .8
4.01 Registration Activities. . . . . . . . . .8
4.02 Regulatory Changes . . . . . . . . . . . .9
ARTICLE 5 COORDINATORS AND MARKETING PLANS. . .9
5.01 Coordinators . . . . . . . . . . . . . . .9
5.02 Marketing Plans; Sales Forecasts . . . . .9
5.03 IMMU Marketing Rights. . . . . . . . . . 10
5.04 Sampling . . . . . . . . . . . . . . . . 11
ARTICLE 6 SUPPLY . . . . . . . . . . . . . . . 11
<PAGE>
6.01 Exclusive Supply; Requirements . . . . . 11
6.02 IMMU's Supply Efforts. . . . . . . . . . 11
6.03 Finished Dose Packaging. . . . . . . . . 11
6.04 Delivery Forecasts . . . . . . . . . . . 11
6.05 Transportation Terms . . . . . . . . . . 12
6.06 Conflicting Terms. . . . . . . . . . . . 12
ARTICLE 7 PRODUCT PRICING; PAYMENT . . . . . . 12
7.01 Purchase Price . . . . . . . . . . . . . 12
7.02 Invoicing. . . . . . . . . . . . . . . . 12
7.03 Payment. . . . . . . . . . . . . . . . . 13
7.04 Currency . . . . . . . . . . . . . . . . 13
ARTICLE 8 COMPLAINTS/RECALLS . . . . . . . . . 14
8.01 Complaints . . . . . . . . . . . . . . . 14
8.02 Recall . . . . . . . . . . . . . . . . . 14
8.03 Regulatory Records; Adverse Reactions. . 14
ARTICLE 9 PRODUCT IDENTIFICATION AND TRADEMARK 15
9.01 Use of IMMU Trademarks . . . . . . . . . 15
9.02 Ownership of Marks . . . . . . . . . . . 15
ARTICLE 10 WARRANTIES AND INDEMNIFICATION. . . 15
10.01 Manufacturing Warranty. . . . . . . . . 15
10.02 Corporate Authority . . . . . . . . . . 16
10.03 MM Indemnification. . . . . . . . . . . 16
10.04 IMMU Indemnification. . . . . . . . . . 16
10.05 Indemnification Procedures. . . . . . . 16
10.06 Insurance Coverage. . . . . . . . . . . 18
ARTICLE 11 PATENT AND TRADEMARK INFRINGEMENT . 18
11.01 Patents . . . . . . . . . . . . . . . . 18
11.02 Infringement of IMMU's Rights . . . . . 19
11.03 Infringement of Third Party Rights. . . 19
ARTICLE 12 TERM AND TERMINATION. . . . . . . . 19
12.01 Term. . . . . . . . . . . . . . . . . . 19
12.02 Mutual Termination Rights . . . . . . . 20
12.03 Competitive Product . . . . . . . . . . 20
12.04 Market Diligence. . . . . . . . . . . . 21
12.05 Lack of Product Registration. . . . . . 21
12.06 Reduction in Sales Force. . . . . . . . 21
12.07 Rights and Obligations Upon Termination 21
ARTICLE 13 CONFIDENTIALITY . . . . . . . . . . 22
13.01 Confidentiality . . . . . . . . . . . . 22
<PAGE>
13.02 Advertising and Publicity . . . . . . . 22
13.03 Disclosure Required by Law. . . . . . . 22
13.04 Manuscripts . . . . . . . . . . . . . . 23
ARTICLE 14 MISCELLANEOUS . . . . . . . . . . . 23
14.01 Governing Law; Choice of Forum. . . . . 23
14.02 Independent Contractor. . . . . . . . . 23
14.03 Accounting Audits . . . . . . . . . . . 24
14.04 Interest Due on Late Payments . . . . . 24
14.05 Taxes . . . . . . . . . . . . . . . . . 24
14.06 Employees . . . . . . . . . . . . . . . 25
14.07 Assignment. . . . . . . . . . . . . . . 25
14.08 Notices . . . . . . . . . . . . . . . . 25
14.09 Force Majeure . . . . . . . . . . . . . 25
14.10 Waiver. . . . . . . . . . . . . . . . . 26
14.11 Partial Invalidity. . . . . . . . . . . 26
14.12 Captions. . . . . . . . . . . . . . . . 26
14.13 Integration . . . . . . . . . . . . . . 26
14.14 Counterparts; English language. . . . . 27
SCHEDULE A FORECASTED UNIT SALES
SCHEDULE B MARKETING EXPENDITURES
SCHEDULE C MM WAREHOUSE AND STORAGE LOCATIONS
<PAGE>
Distribution and Marketing Agreement
This Agreement is made and effective as of the 4th day
of April, 1996, by and between Immunomedics Inc., a Delaware
corporation located at 300 American Road, Morris Plains, New
Jersey (hereinafter referred to as "IMMU") and Mallinckrodt
Medical, Inc., a Delaware corporation with its principal
offices located at 675 McDonnell Boulevard, St. Louis,
Missouri (hereinafter referred to as "MM").
WHEREAS, IMMU possesses rights in and to an in-vivo
diagnostic imaging product known as CEA-Scan(TM), and IMMU
desires to expedite the establishment of CEA-Scan(TM) as a
significant product in the United States pharmaceutical and
nuclear medicine marketplace; and
WHEREAS, IMMU has completed Phase III clinical trials
for CEA-Scan(TM) for colorectal cancer imaging and filed for
approval of the Product with the United States Food & Drug
Administration ("FDA"); and
WHEREAS, MM has considerable knowledge in distributing,
promoting, detailing and marketing nuclear medicine products
in the United States and has in place an experienced
distribution, marketing and selling organization to address
the United States market; and
WHEREAS, MM desires to obtain rights to distribute
CEA-Scan(TM) in the United States market for use in colorectal
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(TM)
in the United States; and
WHEREAS, IMMU believes that a distribution, promotion,
and marketing arrangement with MM regarding CEA-Scan(TM) for
colorectal cancer imaging would be desirable and fully
compatible with IMMU's worldwide marketing and business
objectives with respect to CEA-Scan(TM);
NOW, THEREFORE, in consideration of the premises and
the mutual covenants contained herein, IMMU and MM hereby
agree as follows:
<PAGE>
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 Marketing and
Distribution 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 prior to its disclosure 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
<PAGE>
throughout the world covering the Product,
including, by way of example: New Drug
Applications ("NDAs"), Product License
Applications ("PLAs") and Product Licenses
("Pls").
1.04 "Contract Year" shall mean a period of twelve
months commencing on the Effective Date or on
any successive anniversary of the Effective
Date.
1.05 "Coordinator" shall mean the individual
designated as the principal representative of a
party pursuant to the provisions of Section 5.01
hereof.
1.06 "Effective Date" shall mean the first day of the
month first written above.
1.07 "FDA" shall mean the United States Food & Drug
Administration.
1.08 "Gross Sales" shall mean the gross invoiced
price for the sales of the Product to end users
through MM, its Affiliates and its Sub-Consignees.
1.09 "Meeting" in the context of the Coordinators
shall mean any means of communication, including
written correspondence and telephonic
conferences.
1.10 "IMMU Patents" shall mean those patents owned by
IMMU or exclusively licensed to IMMU covering
the Product.
1.11 "Net Sales" shall mean Gross Sales less (i) any
credits and allowances actually granted by IMMU
to IMMU 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 IMMU in the ordinary
course of business, (ii) any sales, excise,
value-added, turnover or similar taxes, and
(iii) transportation, insurance and handling
expenses if separately invoiced and directly
chargeable to such sales.
1.12 "Person" shall mean any individual, corporation,
partnership, business trust, business
association, governmental entity, governmental
authority or other legal entity.
1.13 "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(TM)"). 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").
1.14 "Sub-Consignee" shall mean an entity experienced
in the distribution of radio pharmaceuticals
that has entered into an agreement with MM under
which it will act as an agent for IMMU for the
sale of the Product on a consignment basis.
1.15 "Territory" shall mean the fifty states of the
United States of America.
<PAGE>
ARTICLE 2
APPOINTMENT
2.01 Appointment. IMMU hereby appoints MM as its
consignee and, subject to Sections 2.03 and
2.04, exclusive distributing agent for the
Product during the term of this Agreement to
launch, detail, promote, advertise and
distribute the Product in the Territory on
behalf of IMMU for use in colorectal cancer
diagnostic imaging and to sell the Product for
such use on behalf of IMMU on a consignment
basis.
2.02 Title and Risk of Loss. All Product delivered
to MM by IMMU hereunder will be held by MM on
consignment and will remain at all times under
and subject to the ownership, direction and
control of IMMU until sold through MM or its
Sub-Consignees to the ultimate customers. Title
to the Product held by MM on consignment will
pass directly from IMMU to the customers who
purchase the Product through MM or its Sub-Consignees.
Title to the technetium-99m ("Tc-99m")
incorporated by MM in the preparation of
the Finished Product shall pass from MM to IMMU
at the time of such incorporation. IMMU shall
bear the risk of loss of the Product not yet
delivered by MM to a customer, whether by fire,
theft, or other casualty; provided, however,
that MM shall reimburse IMMU * per vial
for any Product which is lost or damaged as a
result of MM's negligence including, but not
limited to failure to perform the Tc-99m
labeling properly or delayed delivery of the
Product. IMMU is hereby granted a security
interest in the consigned stock held by MM and
in all proceeds from sales made therefrom,
including accounts receivable and cash receipts.
MM shall execute and deliver to IMMU such
instruments as IMMU shall require, including UCC
financing statements, to enable IMMU to perfect
such security interest. Attached as Schedule C
is a list of MM warehouses or other storage
locations at which MM will maintain supplies of
the Product; during the term of this Agreement,
MM shall notify IMMU promptly of any changes or
additions to the locations at which supplies of
the Product will be maintained, including
without limitation locations of Sub-Consignees.
2.03 Appointment of Sub-Consignee. In order to
maximize distribution of the Product, MM shall
have the right to engage, and MM shall use its
best efforts to engage, other entities,
including without limitation
* and *,
Inc. *, as Sub-Consignees and
distributing agents, sharing with such
Sub-Consignees such portions of the fees
<PAGE>
payable to MM by IMMU hereunder as MM and such
Sub-Consignees shall in good faith negotiate.
IMMU shall not participate in such negotiations.
However, in the event that MM does not reach
agreement on the engagement as a Sub-Consignee
of * or * within * months of the
Effective Date, or of another third-party
radiopharmacy company deemed by IMMU to be
material to the successful distribution of the Product
within * months of IMMU having notified MM of its
judgment that such radiopharmacy company is so
material, then IMMU shall have the right to
enter into a separate consignment agreement with
such company or companies.
In all agreements with Sub-Consignees, MM shall
require the Sub-Consignees to carry out the same
obligations as MM would be required under the
terms of this Agreement to carry out with regard
to the Product delivered on consignment to such
Sub-Consignee, including without limitation the
obligations to adhere to the same standards of
sales conduct, to effect sales only on the basis
of IMMU's approved credit terms, to refrain from
selling other than on a C.O.D. basis to
customers placed on a restricted list by IMMU,
and to provide information regarding sales and
inventory. MM shall be responsible to IMMU for
the conduct of its Sub-Consignees and for the
enforcement of its agreements with its Sub-Consignees.
2.04 Reservation of Rights. IMMU reserves to itself
and its Affiliates the right to market and sell
the Product independent of MM and its Sub-Consignees
directly to hospital nuclear medicine
departments in the Territory and to contract
independently for a specialty oncology sales
force to market the Product at IMMU's expense,
and, subject to IMMU's existing License
Agreement, dated March 10, 1995, with MM's
Affiliate, Mallinckrodt Medical, B.V., to
manufacture, market and sell the Product
independent of MM in and for countries located
outside the Territory, including without
limitation, the right to appoint other Persons
as marketing representatives, dealers,
distributors and manufacturers for sale of the
Product outside 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 cancer diagnostic imaging 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
<PAGE>
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. Pursuant to this undertaking, MM
shall direct its nuclear medicine sales force,
as well as a specialty sales force, to educate
the nuclear medicine and oncology communities
regarding the Product and to actively promote
the sale of the Product to such communities.
During the first * following the
Effective Date, MM shall retain a nuclear
medicine sales force of at least *
representatives, as well as a specialty sales
force of at least * representatives whose
focus is oncologists. Upon receipt by IMMU of
a Product License ("PL") from the FDA with
respect to the Product, MM shall cause such
oncology sales force to be expanded to at least
* representatives. At any time after the
* of the launch of the Product,
MM shall have the right to reduce the size of
its nuclear medicine sales force, generally, or
its specialty oncology sales force, provided
that IMMU shall have the right to terminate the
Agreement if such reduction exceeds * of the
aggregate number of individuals contemplated by
this Section 3.01.
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 FDA.
All promotional materials prepared through MM
and all promotional activities relating to the
Product sold through MM shall comply with all
applicable state and federal laws and FDA rules
and regulations.
3.03 MM's Authority/Responsibility. During the term
of this Agreement, except as otherwise expressly
herein provided, MM shall have the
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 to
actively market the Product within the
Territory, 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) providing IMMU with shipping
information as to MM's own sales on
a daily basis and as to sales by
Sub-Consignees as promptly as
possible but no less frequently that
once a month; and invoicing the
customer on an IMMU invoice on the
same invoicing cycle as MM or its
Sub-Consignees utilizes with their
other products;
<PAGE>
(iii) handling all returns of the Product.
Should the Product be returned
directly to IMMU, IMMU shall
promptly advise MM of such return.
IMMU shall, in it sole discretion,
decide whether to accept the return.
The parties will share the cost of
the return as a reduction of Gross
Sales;
(iv) handling, in accordance with Section
8.02 hereof, all recalls of the
Product;
(v) handling Product distribution,
shipping, inventory tracking and lot
tracing;
(vi) preparing technetium-99m-labeled
unit doses of the Product and
quality control testing to assure
the safety and efficacy of the
Product; and
(vii) packaging of Product in dosage units
for cold kit (non unit dose) orders.
3.04 Restricted List. IMMU and MM, through its
Coordinators or otherwise, shall in good faith
cooperate to establish and regularly update a
list of customers whose credit ratings and
experience are unacceptable to IMMU (the
"Restricted List"). Sales of the Product
through MM or its Sub-Consignees to customers
appearing on such Restricted List shall be made
only on a C.O.D. basis. In the event MM or a
Sub-Consignee sells Product to a customer on the
Restricted List other than on a C.O.D. basis, MM
or such Sub-Consignee shall bear the risk of
non-payment by that customer and shall be liable
to IMMU for the amount owed by the customer but
not paid to IMMU, including interest at the rate
generally charged to customers by IMMU. In such
event, IMMU shall give notice to MM of such non-payment
no later than 90 days after the initial
bill is mailed to the unapproved customer. MM
shall pay, or cause its Sub-Consignee to pay, to
IMMU within 120 days from the date on which the
initial bill was mailed to the unapproved
customer the full amount owed by the unapproved
customer on that date, including interest at the
rate generally charged to customers by IMMU.
3.05 Sales for Export. MM shall not export the
Product from the Territory and shall use
reasonable diligence to ensure that Product sold
through MM on a consignment basis is not sold
with a view to export from the Territory.
Correspondingly, IMMU shall use reasonable
diligence to ensure that Product sold outside
the Territory is not sold with a view to export
into the Territory.
3.06 Non Compete. During the term of this Agreement
MM shall not launch, detail, promote, advertise,
distribute or sell in the Territory a monoclonal antibody
<PAGE>
based in-vivo diagnostic imaging
product which competes with the Product for
colorectal cancer indications.
3.07 Minimum Marketing and Selling Efforts. Without
limiting its obligations under Section 3.01
above, in each of the first two Contract Years
of the term of this Agreement, MM shall at a
minimum expend with third parties, 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, and other miscellaneous efforts
relating exclusively to the distribution and
sale of the Product in the territory. By notice
given to MM not later than January 1, 1998, IMMU
shall have the right to direct MM to make an
additional * of such expenditures in
the Contract Year commencing in 1998. With
respect to each Contract Year commencing after
1998, IMMU shall have the right to request that
MM make an additional * of such
expenditures, but MM shall have no obligation to
agree to such request. IMMU shall make any such
request by notice given to MM not later than
January 1 of the year prior to that to which the
request relates, and MM shall notify IMMU as to
whether or not it agrees to be bound to make
such an additional expenditure within thirty
(30) days of the delivery to MM of IMMU's
request.
MM shall deliver to IMMU a certificate within
forty-five (45) days after each Contract Year
during the term of this Agreement setting forth
in reasonable detail the actual amounts actually
expended by MM for promotion, marketing,
selling, training, and other miscellaneous
expenditures relating to the Product during such
period.
3.08 PL Fee. Upon issuance by the FDA of a PL for
the Product, in partial consideration for the
rights granted to MM hereunder, MM shall pay to
IMMU a one-time, non-refundable, non-creditable
fee of *.
ARTICLE 4
PRODUCT REGISTRATIONS
4.01 Registration Activities. IMMU shall use all
reasonable diligence in pursuing the processing
of its existing filing with the FDA to obtain a
PL for use of the Product as an in vivo
colorectal cancer diagnostic imaging agent.
Through its Coordinator, IMMU shall keep MM
fully apprised of the status of its registration
efforts with respect to the Product with the
FDA.
<PAGE>
4.02 Regulatory Changes. Each party shall promptly
advise the other party of any known new
instructions or specifications relating to the
Product required by the FDA and other applicable
authorities, and the parties shall confer with
respect to the best mode of compliance with such
new requirements. Compliance with such new
requirements shall be the sole responsibility
of IMMU.
ARTICLE 5
COORDINATORS AND MARKETING PLANS
5.01 Coordinators. The parties shall each appoint one
individual (a "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 shall 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 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 this
Agreement, MM shall present its preliminary
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 in the Territory and estimates of
the costs and expenses to implement such
preliminary marketing plan. Such preliminary
marketing plan shall also include sales
forecasts with respect to the Territory for such
forthcoming fiscal year. The Coordinators shall
review and discuss such preliminary 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 preliminary
marketing plan recommended by the Coordinator
representing IMMU. Based upon such review and
recommendations, within thirty (30) days after
such Coordinators' meeting and in any event no
later than June 1 of each year 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
<PAGE>
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 Coordinators, MM
shall present a report of its fulfillment of the
objectives of the then-current Annual Marketing
Plan.
5.03 IMMU Marketing Rights. 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 its own marketing and promotional
expenditures (including Phase IV trials) of up
to * in any Contract Year. Prior to
any exercise of such right, IMMU shall give
notice thereof to MM through communication
between the Coordinators, and such notice shall
specify in reasonable detail the activities
which IMMU intends to undertake. 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 Contract Years following
the expenditure by IMMU of amounts in respect of
such supplemental marketing, actual sales of
unit doses exceed forecasted sales of unit doses
as set forth in Schedule A hereto, IMMU shall be
entitled to recover the cost of such marketing
effort by reducing the fees which would
otherwise be payable to MM as follows:
a) IMMU shall prepare a certificate setting
forth the amount by which sales of unit
doses during the applicable period
exceeded the forecasted sales of unit
doses as set forth in Schedule A hereto
(the "Incremental Sales), as well as the
calculations described in (b) below (the
"Incremental Sales Certificate");
b) In lieu of the fees contemplated by
Section 7.03 hereof that would otherwise
be payable in respect of such Incremental
Sales, IMMU shall pay MM a fee of:
* per unit dose of Product,
whether labeled or sold as a cold
kit, if such Incremental Sales were
made during the period specified in
Section 7.03(a), or $* per
labeled unit dose of Product or
$* per cold kit, if such
Incremental Sales were made during
any other period.
Such payment terms shall remain in effect
as to Incremental Sales until such time as
the difference between (x) the amounts
that would have been payable to MM in
respect of such Incremental Sales under
Section 7.03 but for the operation of this
Section 5.03 and (y) the amounts actually
paid to MM under this Section 5.03 equals
the amount expended by IMMU for its
marketing and selling efforts described in
this Section 5.03. Once such amount has
been fully recovered by IMMU, the
provisions of Section 7.03 shall apply to
the remaining Incremental Sales.
<PAGE>
c) From and after the delivery of the
Incremental Sales Certificate, MM shall
promptly refund to IMMU any fees already
received by MM in respect of the
Incremental Sales which exceed the amounts
otherwise due to MM under the provisions
of this Section 5.03 or, failing which,
IMMU shall have the right to set off such
amounts against future fees owed to MM.
5.04 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 members of the trade on an ongoing
basis ("Sampling Program"). For any such
Sampling Program, the Coordinators, 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.
ARTICLE 6
SUPPLY
6.01 Exclusive Supply; Requirements. IMMU will
deliver on consignment to MM, and MM will
accept delivery from IMMU of all of MM's
requirements of the Product for sale in the
Territory. MM shall order and accept delivery
of 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 the Territory. All such packaging,
labeling and package insert materials prepared
by MM shall comply with all applicable laws,
regulations and guidelines of the FDA. MM shall
bear any and all costs and expenses associated
with labeling changes required by state or
federal law or FDA rules or regulations.
6.04 Delivery Forecasts. 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
<PAGE>
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 date of first
commercial sale to a third party 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.
6.05 Transportation Terms. All orders for the
Product submitted by MM to IMMU hereunder shall
be delivered by IMMU to the MM warehouses or
distribution centers specified by MM. All
costs, taxes, insurance premiums and other
expenses relating to the transportation and
delivery of the Product shall be at IMMU's
expense. Risk of loss of, and damage to, any
shipment shall remain with IMMU, and title shall
at all times remain vested in IMMU.
6.06 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 Sale Price. IMMU shall provide to MM no later
than 90 days following receipt from the FDA of
the PL for the Product a schedule setting forth
the price at which it will sell the Product to
customers. Such price may be changed by IMMU at
any time upon thirty (30) days' advance notice
to MM.
7.02 Invoicing. Upon delivery of the Product to a
customer, MM shall supply that customer with an
IMMU invoice indicating that the amount due for
the Product is to be paid directly to IMMU. At
least once each week, MM shall deliver to IMMU
a complete list of customers to whom it has sold
Product during the immediately preceding week.
Such list shall include all information
necessary to enable IMMU to maintain accounts
receivable and cash receipts for such customers
for the Product delivered, including but not
limited to such information as each serviced
customer's name, address, and telephone number,
the quantity sold to each such customer, the
date the order was placed by each customer, the
date the Product was delivered to each customer,
the address to which the Product was delivered
to each customer, and the name of a contact
<PAGE>
person at the business of each customer. IMMU
shall be responsible for collecting the billing
to each customer for sales of the Product and
shall be the owner of, and bear the credit risk
on, all accounts receivable arising from the
sales of the Product, except as specified in
Section 3.04 hereof.
7.03 Payment. IMMU shall pay MM a quarterly fee
based upon the Net Sales of the Product effected
through MM on a consignment basis as follows:
(a) For sales of Product while MM is actively
engaged in the marketing, promotion, sales and
distribution of the Product:
(i) During the first twelve months after
product launch, *% of such Net Sales or
$* per labeled unit dose of the
Product, whichever is greater;
(ii) Thereafter, for so long as MM
expends at least $* per Contract
Year on marketing and promotion of the
Product, *% of such Net Sales or $*
per labeled unit dose of the Product,
whichever is greater; and
(iii) For cold kits, $* per kit.
(b) For sales of Product while MM is not
actively engaged in the marketing and promotion
of the Product (i.e., for Contract Years in
which MM expends less than $* on such
activities):
(i) During the first Contract Year in
which MM no longer performs such
functions, $* per labeled unit dose of
the Product;
(ii) During each subsequent Contract
Year, $* per labeled unit dose of the
Product;
with such amount to be adjusted for increases in
the Consumer Price Index, as well as increases
in technetium prices above $* per dose;
provided that in no event shall the unit dose
fee exceed $*.
(iii) For cold kits, $* per kit.
7.04 Currency. All payments between the parties 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.
<PAGE>
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
state and federal laws and FDA rules and
regulations. 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 the Territory shall be
IMMU'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 FDA, IMMU shall reimburse MM for
the costs and expenses of such recall and shall
replace such 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 refunds or
replacements 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 by the FDA in connection with the PL
relating to the Product. 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 rules and regulations.
<PAGE>
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(TM) or such other
mark(s) as IMMU shall cause to be registered for
the Product (collectively the "Marks") in the
Territory in connection with, and confined to
the purpose of, the sale, marketing and
distribution of the Product. 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 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
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 Product's PL.
IMMU HEREBY DISCLAIMS ALL OTHER WARRANTIES
REGARDING THE PRODUCT, EXPRESS OR IMPLIED,
INCLUDING WARRANTIES OF MERCHANTABILITY OR
<PAGE>
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 through 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 (including reasonable
attorneys' fees) 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 to 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 (including
reasonable attorneys' fees) 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
<PAGE>
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.
(b) 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 of 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.
(c) 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.
<PAGE>
10.06 Insurance Coverage. (a) 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 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 and shall cause
such policies to provide that they shall not be
canceled by the insurer without thirty (30)
days' prior notice thereof 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 it
has no knowledge of the existence of any patent
in 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
distributing the Product in the Territory.
<PAGE>
11.02 Infringement of IMMU's 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, IMMU, in order to sell the Product
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 the Territory, then IMMU shall have the right
to increase the selling price of the Product to
compensate for such payments, effective on the
date of imposition of such payments.
ARTICLE 12
TERM AND TERMINATION
12.01 Term. This Agreement shall commence on the
Effective Date and, except as provided below in
this Article 12, shall extend until terminated
by either party hereto by notice given to the
other, provided, that:
(a) neither party shall deliver a notice
of termination to the other party prior to the
second anniversary of the Effective Date;
(b) no notice of termination given by
IMMU shall be effective prior to the expiration
of twelve (12) months following the later of (i)
the date of such notice or (ii) the end of the
Contract Year in which MM has made $1 million of
<PAGE>
expenditures of the nature contemplated by
Section 3.07 at IMMU's direction or upon IMMU's
request; and
(c) no notice of termination given by MM
shall be effective prior to the expiration of
twenty four (24) months following the later of
(i) the date of such notice or (ii) the end of
the Contract Year in which MM has made $1
million of expenditures of the nature
contemplated by Section 3.07.
12.02 Mutual Termination Rights. Either party shall
have the right to terminate this Agreement:
(a) 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) days after being called
upon in writing to do so; or
(b) to the extent permitted by law, upon
notice to the other party, 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 part of its property; or
(c) upon notice to the other party
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 cancer indications, and a
"change of control" shall be deemed to have
occurred with respect to a party to this
Agreement if (i) 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, (ii) 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 (iii) 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.
12.03 Competitive Product. In the event that MM or
one of its Affiliates develops another in vivo
diagnostic imaging product for colorectal cancer
indications which is not monoclonal based, MM
shall notify IMMU, simultaneously with
<PAGE>
its first submission of a product registration filing
in the Territory, 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) month prior notice.
12.04 Market Diligence. Without limiting its right to
termination for material breach as contemplated
by Section 12.02, IMMU shall have the right to
terminate this Agreement upon sixty (60) days'
prior notice to MM if: (i) MM's projected unit
sales of the Product as set forth in Schedule A
hereto for the calendar year 1997 is not
achieved in such year; or (ii) MM has
materially failed to fulfill the objectives of
its Annual Marketing Plan for two successive
annual periods.
12.05 Lack of Product Registration. Without limiting
its right to termination for material breach as
contemplated by Section 12.02, MM shall have the
right to terminate this Agreement upon sixty
(60) days' prior notice to IMMU given at any
time between July 1, 1997 and August 31, 1997,
if by June 30, 1997, IMMU shall not have
obtained a product registration for the
marketing of the Product in the Territory.
12.06 Reduction in Sales Force. IMMU shall have the
right to terminate this Agreement upon sixty
(60) days' prior notice to MM given at any time
after MM shall have reduced its sales force
below the minimum numbers of representatives
specified in Section 3.01.
12.07 Rights and Obligations Upon Termination. (a)
Upon any termination of this Agreement, MM shall
promptly return to IMMU or its designee or
otherwise cause to be transferred to IMMU all
Confidential Information of IMMU, and MM shall
have no further rights thereto. 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 through 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, IMMU shall have the right to re-take
possession of all of the inventory of
Product then held by MM at any of its locations.
The provisions of Article 10 and 13 shall
survive any termination of this Agreement.
<PAGE>
ARTICLE 13
CONFIDENTIALITY
13.01 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 the
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. The recipient shall notify and consult
with the disclosing party prior to such
disclosure of information.
13.02 Advertising and Publicity. Subject to Section
13.03 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 either's 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 failure by a party to respond
within such ten (10) business day period shall
be deemed to be approval by such party of such
disclosure, advertising or publicity. 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.
13.03 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
<PAGE>
requirement promptly, but in no 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.
13.04 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 part 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 14
MISCELLANEOUS
14.01 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
Jersey, USA, excluding those laws that relate to
the choice of law. 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 New Jersey, 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.
14.02 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
<PAGE>
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.
14.03 Accounting Audits. Each party shall maintain
books of account relating to its expenditures
pursuant to this Agreement, inventory levels and
in the case of IMMU, Gross Sales and Net Sales,
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
its 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 the other, to
determine whether appropriate accounting has
been made under Sections 3.07, 5.03 and Article
7 hereof. 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 IMMU
to MM during any calendar year exceed amounts
actually paid by five percent (5%) or more, then
IMMU shall, in addition to promptly paying such
shortfall, reimburse MM 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.
14.04 Interest Due on Late Payments. If any amount
payable by one party to the other (the "Creditor
Party") hereunder is not paid when due, then
without limiting any other rights which the
Creditor Party 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 the
Creditor Party to collect the amounts due
hereunder, including but not limited to
reasonable attorneys fees and disbursements.
14.05 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 other rights
hereunder. The parties shall cooperate fully with
each other in obtaining and filing all requisite
certificates and documents with the appropriate<PAGE>
<PAGE>
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
one party to the other hereunder.
14.06 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.
14.07 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.
14.08 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 address or telecopier numbers set
forth below:
Mallinckrodt Medical, Inc.
675 McDonnell Boulevard
St. Louis, MO 63134
Attention: Chief Executive Officer
Telecopier No.
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) if by air
courier, three (3) days after delivery to the
air courier company.
14.09 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,
<PAGE>
injunction or any act, exercise,
assertion or requirement of governmental
authority, including any governmental law, order
or 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 facilities, 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 14.09 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.
14.10 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 any 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.
14.11 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.
14.12 Captions. All captions herein are for
convenience only and shall not be interpreted as
having any substantive meaning.
14.13 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.
<PAGE>
14.14 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, Inc. 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, Inc.
By /s/ David Morra
_______________
Title Vice President
______________
/s/ Mary A. Palank
__________________
Date April 5, 1996
_____________
Attest: Immunomedics, Inc.
By /s/ David M. Goldenberg
_______________________
Title Chairman & CEO
______________
/s/ Melinda Masek
_________________
Date April 8, 1996
_____________
<PAGE>
SCHEDULE A
FORECASTED UNIT SALES
FORECAST
_________________________________________________________
CONTRACT YEAR Year 1 Year 2 Year 3 Year 4 Year 5
_________________________________________________________
UNITS * * * * *
<PAGE>
SCHEDULE B
MARKETING EXPENDITURES
U.S. Dollars (in thousands)
__________________________________________
Contract Year Year 1 Year 2 Year 3
__________________________________________
Promotion * * *
__________________________________________
Marketing * * *
__________________________________________
Selling * * *
__________________________________________
Training * * *
__________________________________________
Other * * *
__________________________________________
TOTAL * * *
__________________________________________
MM shall have the right to make reasonable reallocations of
expenditures among the above described categories provided
such reallocations are identified in its Annual Marketing
Plan.
<PAGE>
<TABLE>
SCHEDULE C
MM WAREHOUSE AND STORAGE LOCATIONS
<CAPTION>
Location RX #
__________________________________________________
<S> <C>
Atlanta 87
2262 Northwest Parkway, Suite M
Marietta, GA 30067
011-087-04-0010
__________________________________________________
Baltimore, MD 70
5024-C Campbell Boulevard
Baltimore, MD 21236
011-070-04-0010
__________________________________________________
Beltsville 80
10850 F Hanna Street
Beltsville, MD 20705
011-080-04-0010
__________________________________________________
Bethlehem 96
2299 Brodhead Road, Suite 1
Bethlehem, PA 18017
011-096-04-0010
__________________________________________________
Boston 78
300 John Dietsch Blvd.
N. Attleboro, MA 02763
011-078-04-0010
__________________________________________________
Chicago 85
4100 N. Elston Avenue
Chicago, IL 60618
011-085-04-0010
__________________________________________________
Columbus 63
2164 Cloverleaf Street E.
Columbus, OH 43232
011-063-04-0010
__________________________________________________
Dallas 93
1212 Dolton, Suite 307
Dallas, TX 75207
011-093-04-0010
__________________________________________________
Dayton 65
4702 Payne Avenue
Dayton, OH 45414
011-065-04-0010
__________________________________________________
Denver 69
1614 Lafayette Street
Denver, CO 80218
011-069-04-0010
__________________________________________________
Detroit 77
2252 East 14 Mile Road
Warren, MI 48092
011-077-04-0010
__________________________________________________
Ft. Lauderdale 75
5450 N.W. 33rd Avenue
Suite 112
Ft. Lauderdale, FL 33309
011-075-04-0010
__________________________________________________
Garfield Heights 92
9455 Midwest Avenue
Garfield Heights, OH 44125
011-092-04-0010
__________________________________________________
Harrisburg 95
4400 Lewis Road, Suite A
Harrisburg, PA 17111
011-095-04-0010
__________________________________________________
Hicksville 88
108 Charlotte Avenue
Hicksville, NY 11801
011-088-04-0010
__________________________________________________
Houston 99
8078 El Rio
Houston, TX 77054
011-099-04-0010
__________________________________________________
Kansas City 73
712 Westport Road
Kansas City, MO 64111
011-073-04-0010
__________________________________________________
Loma Linda 67
11368 Mountain View Ave.,
Suite B
Loma Linda, CA 92354
011-067-04-0010
__________________________________________________
Los Angeles 82
1145 W. 6th Street
Los Angeles, CA 90017
011-082-04-0010
__________________________________________________
Miami (Satellite to Ft. Laud) 75
1645 N.W. 79th Avenue
Miami, FL 33126
011-075-04-0010 11
__________________________________________________
Minneapolis/St. Paul 74
2200 University Avenue West
Suite 170
St. Paul, MN 55114
011-074-04-0010
__________________________________________________
Oakland (Satellite to San Fran.) 81
350 30th Street, Suite G-06
Oakland, CA 94609
011-081-04-0012 12
__________________________________________________
Orlando 76
5135 Adanson
Suite 900
Orlando, FL 32804
011-076-04-0010
__________________________________________________
Philadelphia 98
19 Independence Court
Folcroft, PA 19032
011-098-04-0010
__________________________________________________
Pine Brook 84
P.O. Box 671
26 Chapin Road, Unit 1110
Pine Brook, NJ 07058
011-084-04-0010
Central Zone Regional Office
__________________________________________________
Pittsburgh 94
2722 Penn Avenue
Pittsburgh, PA 15222
011-94-04-0010
Eastern Zone Regional Office
__________________________________________________
Portland 66
2820 S.W. Sam Jackson Park Road
Portland, OR 97201
011-066-04-0010
__________________________________________________
Saginaw (Satellite to Detroit) 77
2795 Universal Drive
Saginaw, MI 48603
011-077-04-0011 11
__________________________________________________
Saint Louis 90
1827 Belt Way Drive
St. Louis, MO 63114
011-090-04-0010
__________________________________________________
Saint Petersburg 86
1511 Commerce Avenue North
St. Petersburg, FL 33716
011-086-04-0010
__________________________________________________
San Francisco 81
1750 Army Street, Unit J
San Francisco, CA 94124
011-081-04-0010
West Zone Regional Mgr.
__________________________________________________
San Jose (Satellite to San Fran.) 81
1328 White Oaks Road
Campbell, CA 95008
011-081-04-0011 11
__________________________________________________
Toledo 61
3222 Hill Avenue
Toledo, OH 43607
011-061-04-0010
__________________________________________________
West Haven 83
470 Frontage Road
West Haven, CT 06516
011-083-04-0010
__________________________________________________
Wilkes-Barre 79
300 Laird Avenue
Wilkes-Barre, PA 18702
011-079-04-0010
__________________________________________________
Canada Radiopharmacies
__________________________________________________
Mississauga/Toronto
7832 Tranmere Drive
Mississauga, Ontario
Canada L5S 1L9
__________________________________________________
Ottawa
595 Montreal Road, Suite 204
Ottawa, Ontario
Canada K1K 4L2
__________________________________________________
Pointe Claire
7500 Trans Canada Highway
Pointe Claire, Quebec
Canada H9R 5H8
__________________________________________________
</TABLE>
