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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K/A
(Amendment No. 2)
(Mark One)
[X] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 [FEE REQUIRED]
For the fiscal year ended JUNE 30, 1996
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 [NO FEE REQUIRED]
Commission file number 0-12104
IMMUNOMEDICS, INC.
(Exact name of registrant as specified in its charter)
DELAWARE 61-1009366
(State of Incorporation) (I.R.S. Employer Identification No.)
300 AMERICAN ROAD, MORRIS PLAINS, NEW JERSEY 07950
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (201) 605-8200
Securities registered pursuant to Section 12(b) of the Act: NONE
Securities registered pursuant to Section 12(g) of the Act:
COMMON STOCK, $.01 PAR VALUE
(Title of Class)
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 requirement for the past 90 days. Yes [X] No
Indicate by check mark if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be contained,
to the best of the registrant's knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. [ ]
As of September 23, 1996, 34,880,365 shares of the registrant's common
stock were outstanding, and the aggregate market value of common stock held by
non-affiliates of the registrant, computed by reference to the last reported
sale price for the registrant's common stock on the Nasdaq National Market at
that date was $185,906,081.
Documents Incorporated by Reference: PORTIONS OF THE REGISTRANT'S DEFINITIVE
PROXY STATEMENT TO BE MAILED TO STOCKHOLDERS IN CONNECTION WITH THE ANNUAL
MEETING OF STOCKHOLDERS OF THE REGISTRANT TO BE HELD ON NOVEMBER 6, 1996 (THE
"1996 DEFINITIVE PROXY STATEMENT"), WHICH WILL BE FILED WITH THE COMMISSION NOT
LATER THAN 120 DAYS AFTER THE END OF THE FISCAL YEAR TO WHICH THIS REPORT
RELATES, ARE INCORPORATED BY REFERENCE IN PART III HEREOF.
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PART IV
ITEM 14. EXHIBITS, FINANCIAL STATEMENT SCHEDULES, AND REPORTS ON FORM 8-K
(a) DOCUMENTS FILED AS PART OF THIS REPORT:
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1. Financial Statements:
Balance Sheets - June 30, 1996 and 1995
Statements of Operations for the years ended June 30, 1996, 1995 and 1994
Statements of Stockholders' Equity for the years ended June 30, 1996, 1995, and 1994
Statements of Cash Flows for the years ended June 30, 1996, 1995, and 1994
Notes to Financial Statements
Report of Independent Auditors - KPMG Peat Marwick LLP
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2. Financial Statements Schedules:
All schedules have been omitted because of the absence of conditions under
which they would be required or because the required information is
included in the financial statements or the notes thereto.
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3. Articles of incorporation and by-laws
3.1(a) Certificate of Incorporation of the Company, as filed with the
Secretary of State of the State of Delaware on July 6, 1982 [e]
3.1(b) Certificate of Amendment of the Certificate of Incorporation of
the Company as filed with the Secretary of State of the State of
Delaware on April 4, 1983 [e]
3.1(c) Certificate of Amendment of the Certificate of Incorporation of
the Company as filed with the Secretary of State of the State of
Delaware on December 14, 1984 [e]
3.1(d) Certificate of Amendment of the Certificate of Incorporation of
the Company as filed with the Secretary of State of the State of
Delaware on March 19, 1986 [e]
3.1(e) Certificate of Amendment of the Certificate of Incorporation of
the Company as filed with the Secretary of State of the State of
Delaware on November 17, 1986 [e]
3.1(f) Certificate of Amendment of the Certificate of Incorporation of
the Company as filed with the Secretary of State of the State of
Delaware on November 21, 1990 [f]
3.1(g) Certificate of Designation of Rights and Preferences, as filed
with the Secretary of State of the State of Delaware on March 1,
1991 [g]
3.1(h) Certificate of Amendment of the Certificate of Incorporation of
the Company, as filed with the Secretary of State of the State of
Delaware on December 7, 1992 [k]
3.1(i) Certificate of Designation of Rights and Preferences of the
Company's Series B Convertible Preferred Stock filed with the
Secretary of State of the State of Delaware on December 21, 1994
[m]
3.1(j) Certificate of Designation of Rights and Preferences of the
Company's Series C Convertible Preferred Stock, as filed with the
Secretary of State of the State of Delaware on September 25, 1995
[q]
3.1(k) Certificate of Designation of Rights and Preferences of the
Company's Series D Convertible Preferred Stock, as filed with the
Secretary of State of the State of Delaware on June 26, 1996 [s]
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3.2 Amended and Restated By-Laws of the Company [k]
4. Instruments defining the rights of security holders, including indentures
4.1 Specimen Certificate for Common Stock [e]
10. Material contracts
10.1(a) 1983 Stock Option Plan, as amended [h]
10.1(b) Form of Stock Option Agreement [e]
10.2 Exclusive License Agreement with David M. Goldenberg, dated as of
July 14, 1982 [a]
10.3 Agreement among The University of Medicine and Dentistry of New
Jersey, the Center of Molecular Medicine and Immunology, Inc. and
Immunomedics, Inc., dated September 16, 1983, including Lease
Agreement [a]
10.4 Agreement among the Company, David M. Goldenberg and the Center
for Molecular Medicine and Immunology, Inc. dated, May 1983 [a]
10.5 Memorandum of Understanding with David M. Goldenberg, dated
September 10, 1984 [b]
10.6 Immunomedics, Inc. 401(k) Retirement Plan [c]
10.7 Executive Supplemental Benefits Agreement with David M.
Goldenberg, dated as of July 18, 1986 [c]
10.8 License Agreement between Hoffmann-La Roche, Inc. and David M.
Goldenberg, dated as of April 29, 1986 [c]
10.9 License Agreement with F. James Primus dated July 7, 1983 [d]
10.10 Employment Letter with Carl Pinsky dated April 29, 1989 [e]
10.11 Amended and Restated License Agreement among the Company, CMMI
and David M. Goldenberg, dated December 11, 1990 [h]
10.12 Development and License Agreement with Adria Laboratories
Division of Erbamont Inc. (Confidential treatment has been
requested for certain portions of
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the Agreement) [h]
10.13 Lease Agreement with Baker Properties Limited partnership, dated
January 16, 1992 [i]
10.14 Amendment to Lease between the University of Medicine and
Dentistry of New Jersey and Immunomedics, Inc., dated August 13,
1992 [j]
10.15 Immunomedics, Inc. 1992 Stock Option Plan [k]
10.16 Amended and Restated Employment Agreement, dated November 1,
1993, between the Company and Dr. David M. Goldenberg [l]
10.17 Convertible Stock Purchase Agreement, dated as of January 6,
1995, between the purchasers named therein [n]
10.18 License Agreement, dated as of March 10, 1995, between the
Registrant and Mallinckrodt Medical, B.V. (Confidential treatment
has been requested for certain portions of the Agreement) [o]
10.19 Amendment, dated March 11, 1995, to the Amended and Restated
License Agreement among the Company, CMMI, and David M.
Goldenberg, dated December 11, 1990 [p]
10.20 Convertible Stock Purchase Agreement, dated as of September 29,
1995, between the Registrant and the purchasers named therein [q]
10.21 Distribution and Marketing Agreement, dated as of April 4, 1996,
between the Registrant and Mallinckrodt Medical, Inc
(Confidential treatment has been requested for certain portions
of the Agreement) [r]
10.22 Manufacturing Agreement, dated June 14, 1996, between the Company
and Pharmacia & Upjohn Oncology Division (Confidential treatment
has been requested for certain portions of the Agreement)
10.23 Convertible Stock Purchase Agreement, dated as of June 27, 1996,
between the Registrant and the purchasers named therein [s]
11. Statement re computation of per share earnings - Not required since such
computation can be clearly determined from the material contained in this
Annual Report on Form 10-K.
12. Statements re computation of ratios - Not applicable.
21. Subsidiaries of the registrant - Immunomedics, B.V.
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23. Consent of Experts and Counsel
23.1 Consent of Independent Auditors - KPMG Peat Marwick LLP [s]
27. Financial Data Schedule [s]
[a] Incorporated by reference from the Exhibits to Registrant's
Registration Statement on Form S-1 effective October 6, 1983 (Commission File
No. 2-84940).
[b] Incorporated by reference from the Exhibits to Registrant's Annual
Report on Form 10-K for the year ended June 30, 1985.
[c] Incorporated by reference from the Exhibits to Registrant's Annual
Report on Form 10-K for the fiscal year ended June 30, 1986.
[d] Incorporated by reference from the Exhibits to Registrant's Annual
Report on Form 10-K for the fiscal year ended June 30, 1988.
[e] Incorporated by reference from the Exhibits to Registrant's Annual
Report on Form 10-K for the fiscal year ended June 30, 1990.
[f] Incorporated by reference from the Exhibits to Registrant's
Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 1990.
[g] Incorporated by reference from the Exhibits to Registrant's
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 1991.
[h] Incorporated by reference from the Exhibits to the Registrant's
Registration Statement on Form S-2 effective July 24, 1991 (Commission File No.
33-41053).
[i] Incorporated by reference from the Exhibits to the Registrant's
Registration Statement on Form S-2 effective January 30, 1992 (Commission File
No. 33-44750).
[j] Incorporated by reference from the Exhibits to Registrant's Annual
Report on Form 10-K for the fiscal year ended June 30, 1992.
[k] Incorporated by reference from the Exhibits to the Registrant's
Annual Report on Form 10-K for the fiscal year ended June 30, 1993.
[l] Incorporated by reference from the Exhibits to the Registrant's
Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 1993.
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[m] Incorporated by reference from the Exhibits to the Registrant's
Quarterly Report on Form 10-Q for the fiscal quarter ended December 31, 1994.
[n] Incorporated by reference from the Exhibits to Amendment No. 1 to
the Registrant's Quarterly Report on Form 10-Q/A for the fiscal quarter ended
December 31, 1994.
[o] Incorporated by reference from the Exhibits to the Registrant's
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 1995.
[p] Incorporated by reference from the Exhibits to the Registrant's
Annual Report on Form 10-K for the fiscal year ended June 30, 1995.
[q] Incorporated by reference from the Exhibits to the Registrant's
Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 1995.
[r] Incorporated by reference from the Exhibits to Amendment No. 1 to
the Registrant's Quarterly Report on Form 10-Q/A for the fiscal quarter ended
March 31, 1996.
[s] Incorporated by reference from the Exhibits to the Registrant's
Annual Report on Form 10-K for the fiscal year ended June 30, 1996.
(b) REPORTS ON FORM 8-K:
The Company filed a Current Report on Form 8-K dated June 28, 1996, with
respect to Item 5 - Other Events.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
Date: February 5, 1997 By:/s/ David M. Goldenberg
------------------------
David M. Goldenberg,
Chairman, Chief Executive Officer
and Treasurer
(Principal Executive Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report
has been signed below by the following persons on behalf of the Registrant and
in the capacities and on the dates indicated.
Date: February 5, 1997 By: /s/ David M. Goldenberg
------------------------
David M. Goldenberg, Chairman
Chief Executive Officer, and
Treasurer (Principal Executive
Officer and Principal Accounting
Officer)
Date: February 5, 1997 By: /s/ Albert D. Angel
--------------------
Albert D. Angel, Director
Date: February 5, 1997 By: /s/ A.E. Cohen
---------------
A.E. Cohen, Director
Date: February 5, 1997 By: /s/ Rolf H. Henel
------------------
Rolf H. Henel, Director
Date: February 5, 1997 By:/s/ Marvin E. Jaffe
-------------------
Marvin E. Jaffe, Director
Date: February 5, 1997 By:/s/ Richard R. Pivirotto
------------------------
Richard R. Pivirotto, Director
Date: February 5, 1997 By: /s/ Warren W. Rosenthal
------------------------
Warren W. Rosenthal, Director
Date: February 5, 1997 By: /s/ Richard C. Williams
------------------------
Richard C. Williams, Director
STATEMENT OF DIFFERENCES
------------------------
The section symbol shall be expressed as.......................'SS'
The registered trademark symbol shall be expressed as..........'r'
The trademark symbol shall be expressed as.....................'tm'
The less than or equal to symbol shall be expressed as.........'<='
The greater than or equal to symbol shall be expressed as.....'>='
The mu symbol shall be expressed as............................'u'
The plus/equal symbol shall be expressed as....................'+='
The degree symbol shall be expressed as........................'[d]'
The double dagger symbol shall be expressed as.................'DD'
The dagger symbol shall be expressed as........................'D'
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MANUFACTURING AGREEMENT
REDACTED
Pharmacia & Upjohn
Oncology Division
Albuquerque, New Mexico
and
Immunomedics, Inc.
Morris Plains, New Jersey
* Confidential portions omitted and filed separately with the Commission.
June, 1996
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TABLE OF CONTENTS
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ARTICLE I. DEFINITIONS.................................................................... 1
1.01 Bulk Solution........................................................ 1
1.02 Product(s)........................................................... 1
1.03 Finished............................................................. 1
1.04 Specifications....................................................... 1
1.05 Master Batch Record.................................................. 1
1.06 PLA.................................................................. 1
1.07 Calendar Year........................................................ 2
1.08 Effective Date....................................................... 2
1.09 Affiliate............................................................ 2
1.10 Person............................................................... 2
1.11 Schedules............................................................ 2
ARTICLE II. THE WORK...................................................................... 2
2.01 Statement of Work.................................................... 2
2.02 Amendments to Statement of Work...................................... 2
2.03 Addition of Other Products to the Agreement.......................... 2
2.04 Work Performed by POD................................................ 3
2.05 Preparation of Bulk Solution......................................... 3
2.06 Use of POD Facilities by IMMUN....................................... 3
2.07 Equipment Provided by IMMUN.......................................... 3
2.08 Compliance With Applicable Rules at the POD Facility................. 3
2.09 Responsibility for Bulk Solution..................................... 4
2.10 Endotoxin Testing.................................................... 4
2.11 Availability of POD Facilities....................................... 4
2.12 Processing of Product in Quarantine.................................. 4
2.13 Regulatory Support................................................... 4
2.14 Facilities Inspection..................................................5
ARTICLE III. FORECAST OF REQUIREMENTS..................................................... 5
3.01 Forecast............................................................. 5
3.02 POD Obligation to Meet Requirements.................................. 5
3.03 Placement of an Order................................................ 5
ARTICLE IV. SHIPMENT & STORAGE OF, & PAYMENT FOR PRODUCT................................... 5
4.01 Storage ............................................................. 5
4.02 Transfer of Product to IMMUN......................................... 6
4.03 Payment for Product....................................................6
4.04 Cancellation Fee..................................................... 6
4.05 Component Fee........................................................ 6
4.06 Late Payment Penalty................................................. 6
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(i)
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ARTICLE V. PRICE OF MANUFACTURE............................................................ 6
5.01 Price................................................................ 6
5.02 Price Increase....................................................... 7
5.03 Notification of Price Increase....................................... 7
5.04 Verification of Increase by Accountant............................... 7
5.05 Accountant's Report.................................................. 7
5.06 Determination that Increase is Unjustified........................... 7
5.07 Price Decrease....................................................... 7
ARTICLE VI. WARRANTIES OF POD............................................................. 8
6.01 The POD Facility..................................................... 8
6.02 Aseptic Processing Environment....................................... 8
6.03 Failure to Comply with Sections 6.01 and 6.02........................ 8
ARTICLE VII. OWNERSHIP OF COMPONENTS AND RISK OF LOSS....................................... 8
7.01 Ownership of Components............................................... 8
7.02 Ownership of Finished Product......................................... 8
7.03 Ownership of Bulk Solution............................................ 8
7.04 Ownership of Equipment................................................ 8
ARTICLE VIII. TERM AND TERMINATION.......................................................... 9
8.01 Term.................................................................. 9
8.02 Voluntary Termination................................................. 9
8.03 Termination for Material Breach....................................... 9
8.04 Termination for Insolvency............................................ 9
8.05 Effect of Expiration or Termination................................... 9
8.06 POD Obligations Upon Expiration or Termination........................ 9
ARTICLE IX. INDEMNIFICATION................................................................ 10
9.01 POD Indemnity........................................................ 10
9.02 IMMUN Indemnity...................................................... 10
ARTICLE X. POD LIABILITY TO IMMUN FOR PRODUCT LOSSES....................................... 11
10.01 Liability for Loss of Product, Bulk Solution,
Equipment and Components............................................. 11
10.02 Parties Disagree Whether Product Out of Specification................ 11
ARTICLE XI. CONFIDENTIALITY................................................................ 11
11.01 Confidential Information............................................. 11
11.02 Limitations on Confidentiality....................................... 12
11.03 Disclosure Required by Law........................................... 12
11.04 Equitable Remedies for Breach of Confidentiality..................... 12
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(ii)
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ARTICLE XII. MISCELLANEOUS................................................................. 12
12.01 Force Majeure........................................................ 12
12.02 New Mexico Gross Receipts & Compensating Tax......................... 13
12.03 Relationship......................................................... 13
12.04 Governing Law........................................................ 13
12.05 Notice............................................................... 13
12.06 Legal Construction................................................... 14
12.07 Entire Agreement, Modifications, Consents, Waivers................... 14
12.08 Section Headings; Construction....................................... 15
12.09 Execution Counterparts............................................... 15
12.10 Product Manufactured Prior to Effective Date......................... 15
ARTICLE XIII. BINDING EFFECT, ASSIGNMENT................................................... 15
SIGNATURE PAGE..............................................................................16
ATTACHMENTS TO AGREEMENT
SCHEDULE 1.04 - Specifications
SCHEDULE 2.01 - Statement of Work
SCHEDULE 2.07 - Equipment List
SCHEDULE 5.01 - Product Pricing Schedule
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(iii)
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MANUFACTURING AGREEMENT
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THIS AGREEMENT entered into this_________ day of June, 1996, between
Pharmacia & Upjohn Oncology Division, 4272 Balloon Park Road, N.E. Albuquerque,
New Mexico 87109 (hereinafter referred to as "POD"), and IMMUNOMEDICS, INC., 300
American Road, Morris Plains, New Jersey 07950 (hereinafter referred to as
"IMMUN").
WHEREAS, IMMUN is a biotechnology company which, using its proprietary
technology and know-how, has developed in vivo cancer imaging products known as
"CEA-Scan'tm'" and LeukoScan'r' (the Products); and
WHEREAS, POD has expertise in the finishing of pharmaceutical products
and has the necessary and proper facilities and employees to undertake such
finishing services and is willing to do so;
NOW, THEREFORE, in consideration of the mutual covenants exchanged
herein, the parties agree as follows:
ARTICLE I. DEFINITIONS
1.01 Bulk Solution. As used herein the term "Bulk Solution" refers to
the formulated solution of Injectable grade in vivo imaging agent solution
prepared at the POD facility by IMMUN personnel.
1.02 Product(s). As used herein the term "Product(s)" shall mean
"finished" Bulk Solutions which are final pharmaceutical dosage forms having the
trade names "CEA-Scan'tm'" or LeukoScan'r' and which are useful as in vivo
imaging agents.
1.03 Finished. The term "finish" or "finished" refers to Bulk Solution
which has been filled into vials, lyophilized, inspected, and packaged by POD in
order to produce finished pharmaceutical dosage forms of the Product(s). The
term "finishing" refers to the process of filling, lyophilization, and packaging
of the Bulk Solution.
1.04 Specifications. As used herein the term "Specification" shall mean
the "Master Batch Record" for each Product and the standards set forth in
Schedule 1.04 attached hereto.
1.05 Master Batch Record. The term "Master Batch Record" as used herein
shall mean the master production and control records required by the FDA to be
kept for each Product pursuant to 21 CFR 'SS'600.12.
1.06 PLA. The term "PLA" is used herein to mean the Product License
Application No. 91-0209 for CEA-Scan'tm' and the Product License Application No.
_________________for LeukoScan'r' covering the Product(s) filed with the United
States Food and Drug Administration ("FDA").
1.07 Calendar Year. The term "Calendar Year" shall mean the consecutive
twelve (12) month period beginning January 1 of a year and ending December 31 of
such year.
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Page 2.
1.08 Effective Date. The "Effective Date" of this Agreement shall be the
date first written hereinabove.
1.09 Affiliate. The term "Affiliate" as used herein shall mean with
respect to any specified Person, any other Person that directly or indirectly
through one or more intermediaries, controls, or is controlled by, or is under
common control with, the Person specified. For purposes of this definition,
"control" including, with correlative meanings, the terms "controlled by" and
"under common control with" means ownership directly or indirectly of more than
thirty percent (30%) of the equity capital having the right to vote for election
of directors in the case of a corporation and more than thirty percent (30%) of
the beneficial interest in the case of a business entity other than a
corporation.
1.10 Person. As used herein the term "Person" shall mean any individual,
corporation, partnership, business trust, business association, governmental
entity, governmental authority or other legal entity.
1.11 Schedules. The Schedules to this Agreement are listed below and are
an integral part of this Agreement and are incorporated herein.
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Schedule Description
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1.04 Specifications
2.01 Statement of Work
2.07 Equipment List
5.01 Price
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ARTICLE II. THE WORK
2.01 Statement of Work. The work to be performed by POD pursuant to the
terms of this Agreement shall be as set forth in the Statement of Work attached
hereto as Schedule 2.01 and as such may be amended from time to time.
2.02 Amendments to Statement of Work. Any amendments made to the
Statement of Work must be mutually agreed to by the parties in writing and must
be attached to Schedule 2.01 whereupon such amendment shall become part of this
Agreement.
2.03 Addition of Other Products to the Agreement. With the written
consent of POD, IMMUN may add additional products to the Agreement to be
finished by POD; provided, however, that POD shall have the unilateral right to
decide whether it wishes to finish such additional products pursuant to this
Agreement. Any additional products added to the Agreement will require their own
Specifications, Statements of Work and determination of "cost" in order to set
the price pursuant to Section 5.01.
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Page 3.
2.04 Work Performed by POD. POD shall be responsible for "finishing" the
formulated bulk Solution supplied to it by IMMUN in accordance with the
Statement of Work to produce Product which meets the Specifications set forth in
Schedule 1.04 attached hereto.
2.05 Preparation of Bulk Solution. IMMUN shall be responsible for the
preparation of the Bulk Solution according to the PLA and shall be responsible
for providing such Bulk Solution to POD, at POD's facilities at such time and in
such quantities as to enable POD to produce Product in accordance with the
Statement of Work.
2.06 Use of POD Facilities by IMMUN. POD shall make its facilities
(including all equipment reasonably required for the preparation of Bulk
Solution) available for IMMUN personnel to prepare Bulk Solution in the quantity
required for the manufacture of lots of Product scheduled for production in
accordance with the scheduling procedures of Section 3.03.
2.07 Equipment provided by IMMUN. IMMUN, where possible, shall provide
all equipment and spare parts for such equipment which will come in contact with
the Bulk Solution for each Product and which shall be suitable and sufficient
for the preparation, holding and filling of each of the Bulk Solutions. Such
equipment shall be provided to POD new and in good working order. POD agrees to
clean, maintain and store such equipment and use it solely for the purpose of
manufacturing the IMMUN product for which it is dedicated. IMMUN shall be
responsible for the repair or replacement of all equipment that becomes
inoperative because of normal wear and tear or improper use by IMMUN employees.
POD shall be responsible for the replacement of such equipment that becomes
inoperative because of improper use by POD employees. A list of the equipment to
be provided by IMMUN is attached as Schedule 2.07.
2.08 Compliance With Applicable Rules at the POD Facility. While
performing the formulation activities at the POD facilities described in Section
2.05, IMMUN personnel shall comply with applicable current Good Manufacturing
Practice as set forth in 21 CFR Part 211, as amended from time to time ("FDA
GMP") and POD's written Standard Operating Procedures ("SOPs") as disclosed to
IMMUN prior to the date hereof. IMMUN agrees to assume any and all risks of its
personnel entering and being in POD's facilities for such formulation activities
and releases POD from any and all claims which may arise due to any injury,
damage or loss which may be suffered by such personnel on such premises;
provided, however, that such assumption and release shall not apply to any risk,
injury, damage or loss caused by or resulting substantially from the negligence
of POD, its employees and agents.
2.09 Responsibility for Bulk Solution. Except as otherwise provided
herein, IMMUN shall be solely liable for any damage to or loss of the Bulk
Solution prepared by IMMUN at the POD facility. POD shall have no obligation or
responsibility to IMMUN for any damage to or loss of such Bulk Solution until
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Page 4.
IMMUN provides such Bulk Solution to POD personnel to begin finishing the Bulk
Solution into Product, unless such loss or damage is due to the negligence of
POD.
2.10 Endotoxin Testing. Unless otherwise agreed to by the parties, POD
shall retain a sample of each batch of final formulated Bulk Solution provided
to it by IMMUN for finishing and POD shall assay the retained sample of final
formulated Bulk Solution for presence of endotoxin to provide a baseline
endotoxin measurement to be used to determine whether endotoxin was introduced
into the Product during the finishing process. If the results of the endotoxin
test indicates that endotoxin was introduced into the Product after compounding
and during finishing then failure of the Product to meet the Endotoxin
Specifications shall be presumed to be the fault of POD and the provisions of
Section 10.01 shall apply.
2.11 Availability of POD Facilities. In the event that the POD
facilities should become unavailable for any reason and for any period of time
resulting in IMMUN being unable to use such facilities to prepare the Bulk
Solution, POD shall promptly notify IMMUN, in writing, and shall use its best
efforts to promptly restore the availability of the facilities for the use of
IMMUN. In the event the POD facilities become unavailable to IMMUN for use
through no fault of POD, POD shall have no liability to IMMUN either direct or
indirect, consequential or inconsequential for any loss or damage suffered by
IMMUN as a result of the unavailability of the POD facilities.
2.12 Processing of Product in Quarantine. In the event POD elects to
process "in quarantine" as set forth in Paragraph 11 of Schedule 2.01, if a
batch or lot of product so processed is rejected, POD shall be responsible for
additional labor and materials costs associated with reworking of the batch or
lot; provided, however, that if IMMUN requests that the batch or lot be further
processed in quarantine, then IMMUN shall be responsible for the additional
labor and material costs if the batch or lot so processed is rejected and must
be reworked.
2.13 Regulatory Support. POD shall provide IMMUN at no additional
charge, with regulatory support for the Drug Master File and for the POD
facilities inspections by the FDA or equivalent foreign health care regulatory
authorities. In the event regulatory support additional to that just described
is required by IMMUN, POD shall provide such support and shall charge IMMUN for
the labor and materials used. Labor shall be charged at the rate specified in
Schedule 5.01 herein and materials shall be charged at cost.
2.14 Facilities Inspection. IMMUN shall have the right to audit POD's
facilities for Good Manufacturing Practices compliance during each year of the
term of the Agreement; provided IMMUN gives POD reasonable prior notice and the
date of the audit is mutually agreed to by the parties. IMMUN agrees that its
employees or agents which inspect POD facilities will comply with POD rules,
regulations and GMP's. IMMUN specifically assumes liability for any injuries,
damages or delays in production resulting solely from
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Page 5.
the action of its employees or agents at POD facilities. There shall be no
charge to IMMUN for POD's cooperation unless more than one audit per year is
scheduled on IMMUN's behalf.
ARTICLE III. FORECAST OF REQUIREMENTS
3.01 Forecast. Within fifteen (15) days after the Effective Date, IMMUN
shall deliver to POD a forecast of the quantity (by batch size) of Product to be
produced by POD for the period from the Effective Date until December 31, 1996
(the "Initial Forecast"). The first three months of the forecast will be
considered a firm commitment for production quantities and the remainder of the
forecast shall be advisory only. Beginning on June 1, 1996, and thereafter on
June 1 of each calendar year of the Agreement, IMMUN shall deliver to POD a
forecast of its requirements for Product for the Calendar Year and shall
thereafter update such Calendar Year forecasts on a monthly basis in order to
allow POD to plan its production schedule for the batch size of Product to be
produced. In the event that IMMUN anticipates a material deviation from the
forecast at any time, IMMUN shall promptly notify POD.
3.02 POD Obligation to Meet Requirements. POD agrees to supply, in each
Calendar Year, all orders placed by IMMUN up to one hundred percent (100%) of
IMMUN's Calendar Year forecast. POD shall use reasonable efforts to supply any
quantity ordered by IMMUN of Product in excess of the forecast subject to POD's
production scheduling capabilities and commitments to other customers.
3.03 Placement of an Order. IMMUN shall initiate an order for Product by
sending to POD a specific purchase order for Product. Once POD takes possession
of the Bulk Solution and begins to finish such Bulk Solution pursuant to the
Statement of Work, IMMUN shall be obligated to accept delivery of and pay for
the Product produced from such Bulk Solution, provided such Product meets the
Specifications. Purchase orders shall be submitted to the attention of Contract
Manufacturing.
ARTICLE IV. SHIPMENT & STORAGE OF, & PAYMENT FOR PRODUCT
4.01 Storage. Finished vials will be stored at the recommended
controlled temperature until shipped as instructed by IMMUN. POD will store the
finished dosage form at no cost up to two weeks after the lots are released to
IMMUN by POD's Quality Assurance Department. Beyond two weeks an additional
charge will be incurred as noted in Schedule 5.01. The parties agree that the
storage of the finished product by POD shall not create or constitute an agency
relationship between the parties. Title to all Product whether approved or
unapproved shall remain with IMMUN and subject to the Provisions of 10.01, risk
of loss of such product shall rest with IMMUN.
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Page 6.
4.02 Transfer of Product to IMMUN. Product shall be shipped to IMMUN by
POD F.O.B. Albuquerque; any deviation from this Section 4.02 must be in writing
and agreed to by POD. There shall be only one shipment per lot of Product.
4.03 Payment for Product. POD shall invoice IMMUN for approved Product
which is "released" in accordance with applicable FDA rules and regulations. The
invoice date shall be either the date of shipment of Product or the date the lot
is released by POD's Quality Department (in the event the lot is not shipped
following release in quarantine to IMMUN by POD's Quality Department). Payment
terms are [*]% in advance with the payment and purchase order received prior to
the manufacture of each lot (F.O.B. Albuquerque). The remaining [*]% of the
price shall be due within ten (10) working days of completion of batch record
review by POD and receipt of the lot(s) by IMMUN if the lots are shipped to
IMMUN or an IMMUN designated location or, if POD stores the lot(s) of Product,
payment of the remaining [*]% will be due ten (10) days after completion of
batch record review by POD.
4.04 Cancellation Fee. A cancellation fee of [*] Dollars [*], plus an
additional charge for labor and materials if applicable, shall be billed to
IMMUN if cancellation or rescheduling by IMMUN of any scheduled batch production
occurs within one (1) week (7 days) of the scheduled manufacture date.
4.05 Component Fee. A component fee equal to [*] times the cost of POD's
components used plus [*] times the costs associated with component preparation
shall be billed to IMMUN if IMMUN fails to cancel a lot one week (7 days) prior
to the scheduled manufacture date.
4.06 Late Payment Penalty. All invoices paid later than ten (10) days
from completion of batch record review by POD will be charged 1.5% interest per
month.
ARTICLE V. PRICE OF MANUFACTURE
5.01 Price. IMMUN shall pay POD for Product in accordance with the price
set forth in Schedule 5.01 attached hereto.
5.02 Price Increase. The price charged by POD for the manufacture of
Product as specified in Section 5.01 shall remain in effect until December 31,
1996. On January 1, of each Calendar Year thereafter, POD shall have the right
to increase the price set forth in Schedule 5.01 to reflect increased
manufacturing costs and increased fixed costs incurred by POD during the
previous twelve (12) month period. Any such price increase shall not exceed ten
percent (10%) of the sum of the manufacturing cost and fixed cost for the
Product determined for the previous twelve (12) month period.
5.03 Notification of Price Increase. POD must notify IMMUN no later than
December 1, 1996 that POD intends to take a price increase and the amount of the
increase (hereinafter the "Increased Cost
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Page 7.
Notice"). At the time POD provides IMMUN with the Increased Cost Notice, POD
shall provide IMMUN with a statement which sets forth, in reasonable detail, the
increased costs and the computation thereof.
5.04 Verification of Increase by Accountant. Within forty-five (45) days
after receipt of the Increased Cost Notice from POD, IMMUN shall have the right
to have any such increase in cost verified by an independent certified public
accountant of its choosing who shall be reasonably acceptable to POD and who
shall execute such nondisclosure agreement with respect to POD's confidential
information as may reasonably be required by POD (a "Nondisclosure Agreement").
5.05 Accountant's Report. The independent accountant described in
Section 5.05 shall issue a report within thirty (30) days of the completion of
the audit, and copies of such report shall be delivered to IMMUN and POD. IMMUN
shall be obligated to pay the increased price for the Product during the period
of the audit and completion of the report.
5.06 Determination that Increase is Unjustified. In the event the audit
of the increased costs shows that such increase is not based on reasonable
evidence of increased costs to POD, the parties shall negotiate in good faith to
determine an acceptable price increase, if any. If the independent auditor
determines that the price increase requested by POD is more than 1.5 times the
increase the independent auditor finds to be supported, POD shall pay for the
cost of such audit.
5.07 Price Decrease. If, as a result of a cooperative effort between POD
and IMMUN relating to the manufacture of IMMUN's products, POD experiences a
decrease in cost of manufacture of Product, e.g., materials, direct labor and
the like or overhead related to the services to be performed by POD under this
Agreement, POD shall notify IMMUN of such decrease and grant IMMUN a reduction
in price equal to the related cost reduction. IMMUN shall have the right, upon
reasonable notice to POD, to have an independent certified public accountant
reasonably acceptable to POD (who shall execute a Nondisclosure Agreement)
review the books and records of POD once every Calendar Year to verify if any
such cost reductions resulting from the joint efforts of IMMUN and POD have
occurred.
ARTICLE VI. WARRANTIES OF POD
6.01 The POD Facility. POD represents and warrants that it shall use its
best efforts to maintain its facilities in such a fashion as to be in compliance
with all applicable federal, state and local rules and regulations. POD agrees
that it will maintain a Type I Drug Master File ("DMF") for the POD facility.
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Page 8.
6.02 Aseptic Processing Environment. POD represents and warrants that it
shall use its best efforts to insure that all filtration, filling and
lyophilization of the Product by POD shall be done in an aseptic processing
environment and in accordance with the Statement of Work.
6.03 Failure to Comply with Sections 6.01 and 6.02. In the event that
POD determines that it is unable to comply with its obligations as specified in
Section 6.01 and Section 6.02, it shall promptly notify IMMUN of its inability
to comply and shall advise IMMUN of what actions POD shall take in order to be
in compliance.
ARTICLE VII. OWNERSHIP OF COMPONENTS AND RISK OF LOSS
7.01 Ownership of Components. All raw materials, active and inactive
ingredients, and secondary components supplied by IMMUN to POD, as between POD
and IMMUN, shall be owned by IMMUN, who shall retain title thereto at all times
and subject to the provisions of Section 10.01, IMMUN shall bear all risk of
loss therefore.
7.02 Ownership of Finished Product. The finished Product shall be owned
by IMMUN, and subject to the provisions of Section 10.01, IMMUN shall bear the
risk of loss for such product while stored at POD's manufacturing or warehouse
facility.
7.03 Ownership of Bulk Solution. IMMUN shall own the Bulk Solution
prepared by IMMUN at POD's facilities pursuant to the provisions of Section 2.04
and subject to the provisions of Section 10.01, IMMUN shall bear the risk of
loss for such Bulk Solution.
7.04 Ownership of Equipment. IMMUN shall own the product contact
equipment IMMUN purchases and provides to POD for use only on the Products.
Subject to the provisions of Section 10.01, IMMUN shall bear the risk of loss
for such equipment while stored at POD's manufacturing or warehouse facility.
POD shall take steps necessary to identify all equipment belonging to IMMUN
sufficient to differentiate such equipment from POD's own equipment.
ARTICLE VIII. TERM AND TERMINATION
8.01 Term. Upon execution by both parties, this Agreement shall be
effective as of the date first set forth above and shall expire on December 31,
1998. IMMUN may renew this Agreement for successive one (1) year periods by
giving notice to POD of IMMUN's intent to renew at least ninety (90) days prior
to
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Page 9.
the expiration of the term; provided however, that POD must consent to the
renewal. POD shall notify IMMUN no later than fifteen (15) days after receipt of
the notice whether it consents to the renewal.
8.02 Voluntary Termination. IMMUN or POD may terminate this Agreement
for any reason, provided that the terminating party first serves written notice
of such termination on the other party no later than one hundred eighty (180)
days prior to the date of such termination.
8.03 Termination for Material Breach. Either party may terminate this
Agreement in the event of a material breach by the other, provided that the
party asserting such breach first serves written notice of the alleged breach on
the offending party and such alleged breach is not cured within thirty (30) days
of said notice.
8.04 Termination for Insolvency. In the event that either party shall
admit in writing that it can not pay its debts, or shall suspend its business,
or shall file a voluntary petition or any answer admitting the jurisdiction of
the court and the material allegations of, or shall consent to, an involuntary
petition pursuant to or purporting to be pursuant to any reorganization or
insolvency law of any jurisdiction, or shall make an assignment for the benefit
of creditors, or shall apply for or consent to the appointment of a receiver or
trustee of all or a substantial part of its property (such party, upon the
occurrence of any such event, a "Bankrupt Party"), then to the extent permitted
by the law the other party hereto may thereafter immediately terminate this
Agreement by giving notice of termination to the Bankrupt Party.
8.05 Effect of Expiration or Termination. Expiration or earlier
termination of this Agreement shall not extinguish rights or obligations
previously accrued or vested.
8.06 POD Obligations Upon Expiration or Termination. Upon the expiration
of this Agreement or its earlier termination, POD shall:
a) at the request of IMMUN, and at IMMUN's expense, return or
dispose of all raw materials, ingredients, components,
equipment, packaging and finished Product to IMMUN or to a
third party pursuant to the instructions of IMMUN; and
b) use its best efforts to assist IMMUN in the transfer of
relevant manufacturing technology and information not
considered to be proprietary to POD to another qualified
manufacturing site; IMMUN shall pay POD for such efforts
in an amount to be determined by the parties.
ARTICLE IX. INDEMNIFICATION
9.01 POD Indemnity. POD agrees to indemnify, protect and defend IMMUN
and hold IMMUN harmless from and against any claims, damages, liability, harm,
loss, costs, penalties, lawsuits, threats of
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Page 10.
lawsuit, recalls or other governmental action, including reasonable attorneys'
fees, brought or claimed by any third party which (i) arise as the result of
POD's breach of this Agreement or of any warranty or representation made to
IMMUN under this Agreement; or, (ii) which result from any claim made against
IMMUN in connection with POD's manufacture of defective Product for IMMUN. Upon
the filing of any such legal claim or lawsuit against IMMUN, IMMUN shall
promptly notify POD, in writing, of any such claim and POD shall, at its
expense, with attorneys reasonably acceptable to IMMUN, handle, defend and
control such claim or lawsuit. Failure to notify POD promptly of the
commencement of any such action, if prejudicial to the ability to defend such
action, shall relieve POD of any liability to IMMUN under this Section 9.01.
IMMUN shall have the right to participate in the defense of such action at its
expense with counsel of its choosing.
9.02 IMMUN Indemnity. IMMUN agrees to indemnify, protect, and defend POD
and hold POD harmless from and against any claims, damages, liabilities, harm,
loss, costs, penalties, lawsuits, threats of lawsuit, recalls or other
governmental action, including reasonable attorneys' fees, brought or claimed by
any third party, which (i) arise out of IMMUN's breach of this Agreement or of
any warranty or representation to POD under this Agreement; or, (ii) result from
the negligent acts or willful malfeasance on the part of IMMUN or employees or
agents, in connection with IMMUN's sale, marketing or distribution of Product
manufactured by POD or other activities or actions in connection with the
Product. Upon the filing of any such legal claim or lawsuit against POD, POD
shall promptly notify IMMUN, in writing, of any such claim and IMMUN shall, at
its expense, with attorneys reasonably acceptable to POD, handle, defend, and
control such claim or lawsuit. Failure to notify IMMUN promptly of the
commencement of any such action, if prejudicial to the ability to defend such
action, shall relieve IMMUN of any liability to POD under this Section 9.02. POD
shall have the right to participate in the defense of such action at its expense
with counsel of its choosing.
ARTICLE X. POD LIABILITY TO IMMUN FOR PRODUCT LOSSES
10.01 Liability for Loss of Product, Bulk Solution, Equipment, and
Components. POD's liability to IMMUN for loss of Product, Bulk Solution,
equipment, component parts of said Product (for example, active drug substance,
excipients), or for out of Specification Product which cannot be reworked,
occurring during the manufacturing process due to the fault of POD shall be
limited to the lesser of the following:
a) [*] per batch or lot of Product; or
b) The actual cost of the Product, Bulk Solution, equipment
or components of the Product.
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Page 11.
In the event of a third-party claim, the provisions of Article IX shall govern
and shall supersede the provisions of this Article X. The parties specifically
agree that the limitation of liability set forth in this Section 10.01 shall
apply to the following Sections: Section 2.09, Section 4.01, Section 4.02,
Section 7.01, Section 7.02, Section 7.03 and Section 7.04.
10.02 Parties Disagree Whether Product Out of Specification. In the case
of a disagreement between the parties as to whether the Product meets the
Specifications, a third party laboratory which is reasonably acceptable to both
parties shall be chosen to act as a neutral referee. The decision of the neutral
referee shall be binding on the parties. The cost of such testing performed by
the laboratory shall be borne by the party found to be in error.
ARTICLE XI. CONFIDENTIALITY
11.01 Confidential Information. Each party ("Receiving Party") shall
maintain in confidence all information heretofore or hereafter disclosed by the
other ("Disclosing Party") which such party knows or has reason to know are
trade secret and other proprietary information owned by or licensed to the
other, including, but not limited to, information relating to the Product
(including without limitation, information developed in preclinical and clinical
studies), and licenses, patents, patent applications, technology or processes
and business plans of the other party, including, without limitation,
information designated as confidential in writing from one party to the other
(all of the foregoing hereinafter referred to as "Confidential Information"),
and shall not use such Confidential Information except as permitted by this
Agreement or disclose the same to anyone other than those of its officers,
directors or employees as are necessary in connection with such party's
activities as contemplated by this Agreement. Each party shall use the same
efforts such party would use to protect its own information to ensure that its
officers, directors and employees do not disclose or make any unauthorized use
of such Confidential Information. Each party shall notify the other promptly
upon discovery of any unauthorized use or disclosure of the other's Confidential
Information.
11.02 Limitations on Confidentiality. The obligation of confidentiality
contained in this Article XI shall not apply to the extent that: i) the
Receiving Party is required to disclose information by applicable law,
regulation or order of a governmental agency or a court of competent
jurisdiction; ii) the Receiving Party can demonstrate that the disclosed
information was at the time of disclosure already in the public domain other
than as a result of actions or failure to act of the Receiving Party, its
officers, directors or employees, in violation hereof; iii) the disclosed
information was rightfully known by the Receiving Party (as shown by its written
records) prior to the date of disclosure to the Receiving Party in connection
with this Agreement; or iv) the
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Page 12.
disclosed information was received by the Receiving Party on an unrestricted
basis from a source which is not under a duty of confidentiality to the other
party.
11.03 Disclosure Required by Law. In the event that the Receiving Party
shall be required to make disclosure pursuant to the provisions of Section 11.02
(i) as a result of the issuance of a court order or other government process,
the Receiving Party shall promptly, but in no event more than forty-eight (48)
hours after learning of such court order or other government process, notify, by
personal delivery or facsimile, all pursuant to Section 12.04 hereof, the
Disclosing Party and, at the Disclosing Party's expense, the Receiving Party
shall: a) take all reasonably necessary steps requested by the Disclosing Party
to defend against the enforcement of such court order or other government
process, and b) permit the Disclosing Party to intervene and participate with
counsel of its choice in any proceeding relating to the enforcement thereof.
11.04 Equitable Remedies for Breach of Confidentiality. The parties
acknowledge that their failure to comply with the provisions of Section 11.01 of
this Article XI may cause irreparable harm and damage to the name and reputation
of the other party for which no adequate remedy may be available at law.
Accordingly, the parties agree that upon a breach by a party of such provisions,
the non-breaching party may, at its option, enforce the obligations of the
breaching party under those provisions by seeking equitable remedies in a court
of competent jurisdiction.
ARTICLE XII. MISCELLANEOUS
12.01 Force Majeure. Neither of the parties to this Agreement shall be
liable to the other party for any loss, injury, delay, damage or other casualty
suffered or incurred by such other party due to strikes, lockouts, accidents,
fire, delays in manufacture, transportation or delivery of material, embargoes,
inability to ship, explosions, floods, war, governmental action or any other
cause similar thereto which is beyond the reasonable control of such other party
and any failure or delay by a party in the performance of any of its obligations
under this Agreement shall not be considered as a breach of this Agreement due
to, but only so long as there exists, one or more of the foregoing causes;
provided, however, that if POD cannot complete an order within ninety (90) days
due to any such cause, IMMUN may cancel the order without liability to POD.
12.02 New Mexico Gross Receipts & Compensating Tax. IMMUN hereby agrees
to be liable for and to pay to POD any sales, use, gross receipts or any other
taxes, licenses or fees (excluding income and franchise taxes) legally incurred
by POD from the State of New Mexico or any other state or tax jurisdiction as a
result of purchasing materials, rendering services, transferring property or any
other action necessary to be taken by POD in order to fulfill the terms of this
Agreement.
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Page 13.
12.03 Relationship. This Agreement shall not be construed to create
between the parties hereto or their respective successors or permitted assignees
the relationship of principal and agent, joint venturers, copartners or any
other similar relationship, the existence of which is hereby expressly denied by
each party. Neither party shall be liable to any third party in any way for
engagement, obligation, contract, representation or transaction or for any
negligent act or omission to act of the other except as expressly provided.
12.04 Governing Law. The provisions of this Agreement shall be governed
in all respects by the laws of the State of New York.
12.05 Notice. All notices, proposals, submissions, offers, approvals,
agreements, elections, consents, acceptances, waivers, reports, plans, requests,
instructions and other communications required or permitted to be made or given
hereunder (all of the foregoing hereinafter collectively referred to as
"Communications") shall be in writing, and shall be deemed to have been duly
made or given when: a) delivered personally with receipt acknowledged; b) sent
by registered or certified mail or equivalent, return receipt requested, or c)
sent by facsimile or telex (which shall promptly be confirmed by a writing sent
by registered or certified mail or equivalent, return receipt requested), or d)
sent by recognized overnight courier for delivery within twenty-four (24) hours,
in each case addressed or sent to the parties at the following addresses and
facsimile numbers or to such other or additional address or facsimile as any
party shall hereafter specify by Communication to the other parties:
To POD: H. Joseph Larsen
Sr. Vice President/General Manager
Pharmacia & Upjohn Oncology Division
4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109
Fax No. (505) 345-7513
For All Issues to POD: Jan Holland Hickey
Director of Contract Manufacturing
Pharmacia & Upjohn Oncology Division
4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109
Fax No. (505) 345-7513
For Quality Issues to POD: Donald E. Hagman, Ph.D.
Vice President, Development/Quality Assurance
Pharmacia & Upjohn Oncology Division
4272 Balloon Park Road, N.E.
Albuquerque, New Mexico 87109
Fax No. (505) 345-7513
To IMMUN: David M. Goldenberg, Sc.D., M.D.
Chairman and CEO
Immunomedics, Inc.
300 American Road
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Page 14.
Morris Plains, New Jersey 07950
Fax No.: 201-605-8282
With a Copy to: Cynthia L. Sullivan
Executive Director, Operations
Immunomedics, Inc.
300 American Road
Morris Plains, New Jersey 07950
Fax No.: 201-605-8282
Notice of change of address shall be deemed given when actually received, all
other Communications shall be deemed to have been given, received and dated on
the earlier of: (i) when actually received, or on the date when delivered
personally; (ii) one (1) day after being sent by facsimile, cable, telex (each
promptly confirmed by a writing as aforesaid) or overnight courier; or four (4)
business days after mailing (except that in the case of any communication given
to a person with an address outside the United States, then ten (10) business
days after mailing).
12.06 Legal Construction. In case any one or more of the provisions
contained in this Agreement shall be invalid or unenforceable in any respect,
the validity and enforceability of the remaining provisions contained herein
shall not in any way be affected or impaired thereby and the parties will
attempt to agree upon a valid and enforceable provision which shall be a
reasonable substitute for such invalid and unenforceable provision in light of
the tenor of this Agreement, and, upon so agreeing, shall incorporate such
substitute provision in this Agreement.
12.07 Entire Agreement, Modifications, Consents, Waivers. This Agreement
together with the Schedules hereto contains the entire agreement of the parties
with respect to the subject matter hereof. This Agreement may not be modified or
amended except by an instrument or instruments in writing signed by the party
against whom enforcement of any such modification or amendment is sought. Each
party hereto may, by an instrument in writing, waive compliance by the other
party hereto with any term or provision of this Agreement on the part of such
other party to be performed or complied with. The waiver by either party hereto
of a breach of any term or provision of this Agreement shall not be construed as
a waiver of any subsequent breach. Neither anything in this Agreement nor the
execution or performance hereof shall be deemed to prejudice in any way, and
each party hereto expressly reserves, any and all rights, remedies, and claims
which each party may now or hereafter have against or with respect to the other
party or any of such other party's Affiliates, relating to any matter which is
not expressly covered by this Agreement.
12.08 Section Headings; Construction. The section headings and titles
contained herein are each for reference only and shall not be deemed to affect
the meaning or interpretation of this Agreement. The words "hereby", "herein",
"hereinabove", "hereinafter", "hereof" and "hereunder", when used anywhere in
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Page 15.
this Agreement, refer to this Agreement as a whole and not merely to a
subdivision in which such words appear, unless the context otherwise requires.
The singular shall include the plural, the conjunctive shall include the
disjunctive and the masculine gender shall include the feminine and neuter, and
vice versa, unless the context otherwise requires.
12.09 Execution Counterparts. This Agreement may be executed in any
number of counterparts and each such duplicate counterpart shall constitute an
original, any one of which may be introduced in evidence or used for any other
purpose without the production of its duplicate counterpart. Moreover,
notwithstanding that any of the parties did not execute the same counterpart,
each counterpart shall be deemed for all purposes to be an original, and all
such counterparts shall constitute one and the same instrument, binding on all
of the parties hereto.
12.10 Product Manufactured Prior to Effective Date. The parties
specifically acknowledge that only Product manufactured by POD upon or after the
Effective date is covered by this Agreement and Product manufactured by POD for
IMMUN prior to the Effective Date is not covered by this Agreement.
ARTICLE XIII. BINDING EFFECT, ASSIGNMENT
In entering into this Agreement, each party hereto has relied upon the
expertise and capabilities of the other. Accordingly, neither party may directly
or indirectly assign, delegate, encumber or in any other manner transfer any of
its rights, remedies, obligations, liabilities or interests in or arising under
this Agreement, without the prior consent of the other, which consent shall not
be unreasonably withheld or delayed, except that either party may directly or
indirectly assign, delegate, encumber or in any other manner transfer any of its
rights, remedies, obligations, liabilities or interests in or arising under this
Agreement, upon prior notice to the other party but without obtaining the prior
consent of such party to:
a) any affiliate of a party; or
b) to any entity which succeeds, by purchasing stock or assets, by
merger or otherwise, to all or substantially all of the assets of
a party or in the case of IMMUN, to any right, title and interest
of IMMUN's to the Product.
Any attempted assignment, delegation, encumbrance or other transfer in violation
of this Agreement shall be void and of no effect, and shall be a material breach
hereof.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed as of the day and year first written above.
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Page 16.
IMMUNOMEDICS, INC. PHARMACIA & UPJOHN ONCOLOGY
DIVISION
By: /s/ David M. Goldenberg By: /s/ H. Joseph Larsen
H. Joseph Larsen
Title: Chairman & CEO Title: Sr. Vice President/General Manager
Date: June 14, 1996 Date: June 12, 1996
(Agreemen\Immufinl)
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SCHEDULE 1.04
SPECIFICATIONS
Current revisions of the Master Batch Record, Document No. 10-228, and Packaging
Batch Record, Document No. PL-IMR, for CEA-Scan'tm' and current revisions of the
Master Batch Record, Document No. 10-290, and Packaging Batch Record, Document
No. PL-IMM, for LeukoScan'r' and the standards set forth on this page constitute
the Specifications.
* * *
POD is responsible for the Products meeting the following standards:
Product sterility
Moisture content by Loss on Drying not greater than [*]%
Fill vials and maintain fill weight within limits of '+='- 0.12
mg/vial of target fill provided by IMMUN personnel on a
Certificate of Analysis.
Endotoxin less than 5 E.U. per vial
Particle testing meeting USP specifications
'<=' 6,000 particles per vial that are '>=' 10'u'm
'<=' 600 particles per vial that are '>=' 25'u'm
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SCHEDULE 2.01
STATEMENT OF WORK
1. All of the work to be performed in processing the Product shall be in
accordance with the Specifications set forth in Schedule 1.04.
2. POD will be responsible for aseptic processing and lyophilization of the
formulated Bulk Solution(s) of Injectable grade CEA-Scan'tm' or
LeukoScan'r', using Bulk Solution(s) prepared at POD by IMMUN personnel.
3. POD will be responsible for furnishing the tested and released Water for
Injection USP, and Nitrogen, NF as required. Argon gas (best grade
available) will be supplied by POD, and IMMUN will be invoiced at POD's
cost for the number of tanks used.
4. POD will membrane sterile filter the Bulk Solution and conduct the
appropriate "in process" quality control testing as specified in
Paragraph 13(d) below, on the buffers, formulated product and sterile
bulk solution prior to filling into vials.
5. Upon receiving a written release from POD's Quality Control Department,
the POD Production Department will aseptically subdivide the sterile
Bulk Solution into the appropriate sterile vial size at a specified fill
weight so that each vial contains the required amount of Product.
6. Filled trays of vials will be held in an enclosed cart purged with Argon
until loaded into the lyophilizer on shelves frozen to[*][d]C. The
aseptically filled vials will then be lyophilized according to a written
Standard Procedure for Freeze Drying.
7. At the completion of the Standard Freeze Drying cycle, the
lyophilization chamber will be restored to the specified pressure with
Nitrogen NF, which will be passed through a suitable, sterilized
microbiological-retentive filter. The lyophilized vials will be
aseptically stoppered inside the chamber, then removed and sealed with
specified aluminum closures in a controlled environment area.
8. The finished vials will be transferred from the capping area where they
are sampled for QC testing.
9. Samples of each lot of finished vials will be sent to IMMUN for testing.
The samples requested by IMMUN will be packed on cold packs and shipped
per IMMUN's written instructions.
10. IMMUN will inform POD in writing of the acceptable or unacceptable test
results as soon as they become available to allow POD to schedule the
product for inspection.
11. The finished vials will be placed in quarantine and stored at the
recommended controlled temperature until released by POD's or IMMUN's
Quality Assurance Departments. IMMUN will be responsible for final
release.
12. Based on POD's release for further processing and/or in conjunction with
IMMUN's release, the Vice President or designee of POD's Quality
Assurance Department will notify POD's Packaging Supervisor that
finished vials can be 100% inspected and bulk packed into their final
configuration. As an alternative, POD may elect to process [*] to reduce
labor costs (i.e., inspect and bulk package
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in quarantine) prior to quality control release. This alternative method
is according to POD's Standard Procedure for the Release and Shipment of
Finished Products and shall be at the risk of POD for additional labor
costs if a lot so processed [*] is rejected. POD will maintain complete
lot identify until the lot is released by IMMUN.
13. In furtherance of the foregoing steps, POD will, in accordance with the
Specifications:
(a) Prepare the batch documents, which shall include the Master Batch
Record as approved by POD and IMMUN.
(b) Furnish the necessary Nitrogen, NF, and Water for Injection, USP,
and test and release these items according to current compendia
methods. Argon will be released on vendor's Certificate of
Analysis. POD will furnish IMMUN with a copy of vendor and/or
POD's Certificates of Analysis upon request.
(c) Furnish the following components and conduct the appropriate
inspection, testing and release thereof, providing IMMUN with
test results and manufacturer's certificate of analysis.
i) Vials (upon depletion of IMMUN stock)
ii) Stoppers
iii) Seals
(d) In support of the on-site manufacturing by IMMUN, conduct the
following In-Process tests:
i) Buffers - pH and conductivity
ii) UV absorbance at 280nm
iii) Prefiltration bioburden
iv) Bulk sterility (post-filtration bioburden)
v) Bacterial endotoxin test on unfiltered bulk solution
(e) Sterile filter the formulated CEA-Scan'tm' or LeukoScan'r'
solution(s) as supplied by IMMUN and conduct the appropriate "in
process" control release as required by fill.
(f) Prepare and sterilize vials and stoppers in accordance with POD's
Standard Procedures.
(g) Prepare aluminum closures for the sealing process.
(h) Aseptically fill vials within tolerance limits set by IMMUN and
hold filled vials in [*] atmosphere until loaded in lyophilizer,
in accordance with SOP's provided by POD.
(i) Freeze dry vials and determine moisture value by Loss on Drying
method (LOD).
(j) Aseptically stopper and seal lyophilized product vials.
(k) Perform limited Quality Control testing of finished dosage form
according to IMMUN specifications as designated in PLA including:
i) Sterility (current U.S.P. confirmation) plus
Staphylococcus aureus ATCC 6598P, (BP - British
Pharmacopeia).
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ii) LOD moisture determination after the sealing operation.
(l) Where possible deliver released batch records and all testing
records to IMMUN within 30 days of manufacture and inspection in
connection with remaining testing of finished dosage form by
IMMUN per current USP and/or internal specifications. [See Item
14(e)].
(m) 100% inspect finished dosage form.
(n) Bulk pack unlabeled vials as directed in IMMUN's packaging
specifications.
(o) Store quarantined vials at [*][d] C until instructed by IMMUN
to ship product.
(p) Ship finished Product to distribution centers designated by
IMMUN.
14. In furtherance of the foregoing steps, IMMUN will, in accordance with
the Specifications:
(a) Furnish POD with sufficient Bulk formulated Products for further
processing. To prepare each Bulk Solution on-site at POD, IMMUN
will ship the following buffers and tested and released materials
to POD:
<TABLE>
<CAPTION>
CEA-Scan'tm' LeukoScan'r'
<S> <C> <C>
i. [*] i. [*]
ii. [*] ii. [*]
iii. [*] iii. [*]
iv. [*] iv. [*]
v. [*] v. [*]
vi. [*]
vii. [*]
</TABLE>
(b) Three (3) ml vials will be used from inventory provided by IMMUN
until depleted. IMMUN will perform the appropriate inspection,
testing and release. POD will only perform an identification
inspection if the vials are sent "released" from IMMUN. If vials
are shipped to POD directly from the vendor, POD will conduct the
appropriate inspection, testing and release.
(c) Keep POD informed of current manufacturing/Quality Control
developments relating to the Product at its current stage of
development and/or commercialization, to the extent necessary for
POD's contract manufacturing function.
(d) Provide, prior to shipment, Material Safety Data Sheets and
decontamination procedures (if required), for all materials
supplied by IMMUN to POD.
(e) Perform Quality Control testing of the finished dosage form per
current USP and/or internal specifications.
(f) Provide final release of Product.
(g) Maintain a complaint file regarding IMMUN and regulatory
complaints and inquiries concerning the Product. The file will be
kept by IMMUN during the term of the Agreement
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and any extensions thereof, and for five (5) years after this
Agreement terminates. A copy of each such complaint or inquiry
which pertains to any activity performed by POD shall be sent to
POD quarterly.
(h) Maintain an adverse reaction file regarding IMMUN or regulatory
complaints and inquiries concerning the Product. The file will be
kept by IMMUN during the term of the Agreement and any extensions
thereof, and for five (5) years after this Agreement terminates.
(i) Provide shipping instructions for samples and final Product. POD
shall maintain such instructions in its file during the term of
this Agreement and for five (5) years thereafter.
(j) Shall be responsible for securing all necessary regulatory
approval for the Product, and shall be responsible for drug
listing of the Product.
(k) Shall receive the original batch records after completion and POD
will retain a copy for its files. Each party shall maintain such
records for a period of five (5) years after the expiration date
of each individual lot.
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SCHEDULE 2.07
EQUIPMENT LIST
<TABLE>
<CAPTION>
Quantity Description
<S> <C>
1 FU-50 filling unit 1000-2
4 3cc syringes w/backups
1 10" filter housing, 1/4" hose barbs
1 3 gallon pressure vessel
1 10 gallon pressure vessel
1 15 gallon pressure vessel
3 3' Stainless steel hose
1 6' Stainless steel hose
1 30' Stainless steel hose
2 40L carboy
1 4L carboy
6 Various size beakers, 1000ml, 250ml
40 Stainless steel triclover clamps
150 Silicone gaskets
2 Silicone bottle stoppers
15 Sanitary end caps with 3/16" hose barbs
10 Quick connect fittings
10 3/16" barb fittings
20' Stainless steel syphon tubing assembly
1 90[d] elbow, 1 1/2diameter
2 Endcaps, 1 1/2"
1 Diaphragm valve 1 1/2"
</TABLE>
<PAGE>
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SCHEDULE 5.01
PRODUCT PRICE SCHEDULE
FIRM UNTIL DECEMBER 31, 1996
Manufacture up to 4,000 vials - $[*]
4,001 to 6,000 vials - $[*] base price plus $[*] per vial for each vial over
4,000 vials and up to 6,000 vials.
6,001 to 8,000 vials - $[*] base price plus $[*] per vial for each vial over
6,000 vials and up to 8,000 vials.
8,001 to 10,000 vials - $[*] base price plus $[*] per vials for each vial over
8,000 vials and up to 10,000 vials.
10,001 to 12,000 vials - $[*] base price plus $[*] per vial for each vial over
10,000 vials and up to 12,000 vials.
12,001 vials to 15,000 vials - $[*] base price plus $[*] per vial for each vial
over 12,000 vials and up to 15,000 vials.
15,001 vials to Hull #2 lyophilizer capacity - $[*] base price plus $[*] per
vial for each vial over 15,000 vials.
(plus N.M. gross receipts tax if applicable)
<TABLE>
<S> <C>
Additional sample shipments'DD' $[*] handling fee for up to 350 vials.
$[*] for each additional increment of
350 vials per shipment. FOB Albuquerque
(e.g., $[*] for 699 vials, $[*] for 800 vials)
Additional finished vial shipments'DD' $[*] per each pallet* ambient
$[*] per each pallet* refrigerated
$[*] per each pallet* frozen
FOB Albuquerque
Waste disposal services'DD' $[*] per batch for normal waste and rejects or
$[*] plus actual destruction costs if entire lot
destroyed
Storage of lots beyond 2 weeks after release:'DD'
Room temperature $[*] per pallet* per month
Refrigerated $[*] per pallet* per month
Frozen $[*] per pallet* per month
Cancellation Charge when fill canceled with $[*] per Aseptic IMMUN Fill plus labor and
less than 7 days notice'DD' materials expended; See Section 4.04 herein.
Additional Regulatory Assistance'DD' $[*] per hour
</TABLE>
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<TABLE>
<S> <C>
Additional labor and materials required to fulf Minimum charge $[*]. Cost of each incident based
changes to batch made with less than 7 days upon the requirements
to complete the request plus notice a nuisance fee.'D'
</TABLE>
* Charges remain the same for all quantities less than one (1) pallet.
'D' Example: To completely process an additional 2,000 vials and
stoppers depending on size and processing requirements could cost $[*].
'DD' Subject to New Mexico Gross Receipts Tax
1. Our prices may be revised if the current manufacturing responsibility,
procedures or analytical requirements are revised by IMMUN.
2. Cancellation Charges: The cancellation charges do NOT include labor and
material costs incurred should IMMUN postpone production in process just
prior to filling. These additional charges will be the responsibility of
IMMUN.
