<PAGE>
AS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION ON NOVEMBER 26, 1996
REGISTRATION NO. 333-13627
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
---------------------
AMENDMENT NO. 5
TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
PROGENICS PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
<TABLE>
<S> <C> <C>
DELAWARE 2834 13-3379479
(State or other jurisdiction (Primary Standard Industrial (I.R.S. Employer
of Classification Code Number) Identification
incorporation or organization) No.)
</TABLE>
777 OLD SAW MILL RIVER ROAD
TARRYTOWN, NEW YORK 10591
(914) 789-2800
(Address, including zip code and telephone number, including area
code, of registrant's principal executive offices)
PAUL J. MADDON, M.D., PH.D.
CHAIRMAN OF THE BOARD, CHIEF EXECUTIVE OFFICER AND PRESIDENT
PROGENICS PHARMACEUTICALS, INC.
777 OLD SAW MILL RIVER ROAD
TARRYTOWN, NEW YORK 10591
(914) 789-2800
(Name, address, including zip code, and telephone number, including area code,
of agent for service)
--------------------------
COPIES OF ALL COMMUNICATIONS, INCLUDING ALL COMMUNICATIONS SENT TO THE AGENT FOR
SERVICE, SHOULD BE SENT TO:
MARK R. BAKER, ESQ. DAVID E. REDLICK, ESQ.
DEWEY BALLANTINE HALE AND DORR
1301 AVENUE OF THE AMERICAS 60 STATE STREET
NEW YORK, NEW YORK 10019 BOSTON, MASSACHUSETTS 02109
(212) 259-8000 (617) 526-6000
--------------------------
APPROXIMATE DATE OF COMMENCEMENT OF PROPOSED SALE TO THE PUBLIC:
As soon as practicable after the effective date of this Registration Statement.
--------------------------
If any of the securities being registered on this Form are to be offered on
a delayed or continuous basis pursuant to Rule 415 under the Securities Act of
1933, check the following box: / /
If this Form is filed to register additional securities for an offering
pursuant to Rule 462(b) under the Securities Act, please check the following box
and list the Securities Act registration statement number of the earlier
effective registration statement for the same offering: / /
If this Form is a post-effective amendment filed pursuant to Rule 462(c)
under the Securities Act, check the following box and list the Securities Act
registration statement number of the earlier effective registration statement
for the same offering: / /
If delivery of the prospectus is expected to be made pursuant to Rule 434,
please check the following box: / /
--------------------------
THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR
DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL
FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION
STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(A) OF
THE SECURITIES ACT OF 1933 OR UNTIL THE REGISTRATION STATEMENT SHALL BECOME
EFFECTIVE ON SUCH DATE AS THE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(A),
MAY DETERMINE.
- --------------------------------------------------------------------------------
- --------------------------------------------------------------------------------
<PAGE>
PART II
INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following is an itemized statement of the estimated amounts of all
expenses payable by the Registrant in connection with the registration of the
Common Stock offered hereby, other than underwriting discounts and commissions:
<TABLE>
<S> <C>
Registration Fee--Securities and Exchange Commission............ $ 9,061
NASD Filing Fee................................................. 3,490
Blue Sky fees and expenses...................................... 20,000
Accountants' fees and expenses.................................. 350,000
Legal fees and expenses......................................... 500,000
Printing and engraving expenses................................. 250,000
Transfer agent and registrar fees............................... 5,000
Miscellaneous................................................... 2,449
---------
Total............................................... $1,140,000
---------
---------
</TABLE>
ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Section 145(a) of the General Corporation Law of the State of Delaware (the
"DGCL") provides that a Delaware corporation may indemnify any person who was or
is a party or is threatened to be made a party to any threatened, pending or
completed action, suit or proceeding, whether civil, criminal, administrative or
investigative (other than an action by or in the right of the corporation) by
reason of the fact that he is or was a director, officer, employee or agent of
the corporation or is or was serving at the request of the corporation as a
director, officer, employee or agent of another corporation or enterprise,
against expenses, judgments, fines and amounts paid in settlement actually and
reasonably incurred by him in connection with such action, suit or proceeding if
he acted in good faith and in a manner he reasonably believed to be in or not
opposed to the best interests of the corporation, and, with respect to any
criminal action or proceeding, had no cause to believe his conduct was unlawful.
Section 145(b) of the DGCL provides that a Delaware corporation may
indemnify any person who was or is a party or is threatened to be made a party
to any threatened, pending or completed action or suit by or in the right of the
corporation to procure a judgment in its favor by reason of the fact that such
person acted in any of the capacities set forth above, against expenses actually
and reasonably incurred by him in connection with the defense or settlement of
such action or suit if he acted under similar standards, except that no
indemnification may be made in respect of any claim, issue or matter as to which
such person shall have been adjudged to be liable to the corporation unless and
only to the extent that the court in which such action or suit was brought shall
determine that despite the adjudication of liability, such person is fairly and
reasonably entitled to be indemnified for such expenses which the court shall
deem proper.
Section 145 of the DGCL further provides that to the extent a director or
officer of a corporation has been successful in the defense of any action, suit
or proceeding referred to in subsections (a) and (b) or in the defense of any
claim, issue, or matter therein, he shall be indemnified against expenses
actually and reasonably incurred by him in connection therewith; that
indemnification provided for by Section 145 shall not be deemed exclusive of any
other rights to which the indemnified party may be entitled; and that the
corporation may purchase and maintain insurance on behalf of a director or
officer of the corporation against any liability asserted against him or
incurred by him in any such capacity or arising out of his status as such
whether or not the corporation would have the power to indemnify him against
such liabilities under such Section 145.
II-1
<PAGE>
Section 102(b)(7) of the DGCL provides that a corporation in its original
certificate of incorporation or an amendment thereto validly approved by
stockholders may eliminate or limit personal liability of members of its board
of directors or governing body for breach of a director's fiduciary duty.
However, no such provision may eliminate or limit the liability of a director
for breaching his duty of loyalty, failing to act in good faith, engaging in
intentional misconduct or knowingly violating a law, paying a dividend or
approving a stock repurchase which was illegal, or obtaining an improper
personal benefit. A provision of this type has no effect on the availability of
equitable remedies, such as injunction or rescission, for breach of fiduciary
duty. The Company's Restated Certificate of Incorporation contains such a
provision.
The Company's Certificate of Incorporation and By-Laws provide that the
Company shall indemnify officers and directors, and to the extent authorized by
the Board of Directors, employees and agents of the Company, to the full extent
permitted by and in the manner permissible under the laws of the State of
Delaware. In addition, the By-Laws permit the Board of Directors to authorize
the Company to purchase and maintain insurance against any liability asserted
against any director, officer, employee or agent of the Company arising out of
his capacity as such.
The Company has entered into Indemnification Agreements with each of its
officers and directors, pursuant to which the Company has agreed to indemnify
and advance expenses to such officers and directors to the fullest extent
permitted by applicable law.
The Company has obtained an insurance policy providing coverage for certain
liabilities of its officers and directors.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES
During the past three years, the Registrant has issued securities to a
limited number of persons, as described below. No underwriter or underwriting
discounts or commissions were involved. There was no public offering in any such
transaction and the Company believes that each transaction was exempt from the
registration requirements of the Securities Act of 1933 (the "Securities Act")
by reason of Section 4(2) thereof based on the private nature of the
transactions and the sophistication of the purchasers, all of whom had access to
information concerning the Registrant and acquired the securities for investment
and not with a view to the distribution thereof.
From January 1993 through August 1993, the registrant issued a total of
272,270 shares of Series B Preferred Stock, $.001 par value per share, and
warrants to purchase 272,270 shares of Series B Preferred Stock, to 33
individuals and entities of whom two entities are affiliates of the Company, one
individual is a director and the rest are accredited investors for an aggregate
purchase price of $1,089,080 in cash.
In September 1993 and October 1993, the registrant issued a total of 562,500
shares of Series B Preferred Stock, and warrants to purchase 562,500 shares of
Series B Preferred Stock, to three entities of whom two entities are affiliates
of the Company and the remaining entity is an accredited investor for an
aggregate purchase price of $2,250,000.
In February 1994, the registrant issued a total of 719,310 shares of Series
B Preferred Stock to 22 individuals and entities of whom one entity is an
affiliate of the Company, one individual is a director and the remaining
individuals and entities are accredited investors for an aggregate purchase
price of $3,596,550 in cash.
In November 1995 and December 1995, the registrant issued a total of 424,184
shares of Series C Preferred Stock, $.001 par value per share, and warrants to
purchase 106,046 shares of Series C Preferred Stock, to seven individuals and
entities of whom one individual is a director, two entities are affiliated with
a director of the Company and the remaining individuals and entities are
accredited investors for an aggregate purchase price of $897,249 in cash and
conversion of a note payable in the principal amount of $1,200,000 plus accrued
interest thereon of $23,671.
II-2
<PAGE>
In December 1995, the registrant issued 45,000 shares of Common Stock,
$.0013 par value per share, to one entity which is a licensor as partial
consideration for a license agreement.
In January 1996 and February 1996, the registrant issued a total of 964,812
shares of Series C Preferred Stock, and warrants to purchase 241,203 shares of
Series C Preferred Stock, to 52 individuals and entities of whom two entities
are affiliates of the Company, two individuals are directors and the remaining
individuals and entities are accredited investors for an aggregate purchase
price of $4,824,060 in cash.
From January 1, 1993 to September 30, 1996, the Company issued options to
purchase 1,549,163 shares of Common Stock (of which options to purchase 57,750
shares of Common Stock subsequently have been cancelled) to employees and
consultants of the Company pursuant to the 1989 Option Plan, the 1993 Option
Plan and the 1993 Executive Option Plan. None of such options has been
exercised.
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) Exhibits
<TABLE>
<C> <S>
**1.1 --Form of Underwriting Agreement
**3.1 --Certificate of Incorporation, as amended, of the Registrant
**3.2 --By-Laws of the Registrant
**4.1 --Specimen Certificate for Common Stock, $0.0013 par value per share, of the
Registrant
**5.1 --Opinion of Dewey Ballantine
**10.1 --Form of Registration Rights Agreement
**10.2 --1989 Non-Qualified Stock Option Plan
**10.3 --1993 Stock Option Plan, as amended
**10.4 --1993 Executive Stock Option Plan
**10.5 --Amended 1996 Stock Incentive Plan
**10.6 --Form of Indemnification Agreement
**10.7 --Employment Agreement dated December 15, 1993 between the Registrant and Dr. Paul
J. Maddon
**10.8 --Letter dated August 25, 1994 between the Registrant and Dr. Robert J. Israel
**10.9 --Sublease dated July 13, 1988 between the Registrant and Union Carbide Corporation
+10.10 --gp120 Supply Agreement dated July 19, 1995 between the Registrant and E. I.
DuPont De Nemours and Company, as amended October 27, 1995
+10.11 --sCD4 Supply Agreement dated June 27, 1995 between the Registrant and E. I. DuPont
De Nemours and Company
**+10.12 --Supply Agreement dated February 8, 1996 between the Registrant and Intracel
Corporation
**+10.13 --License Agreement dated November 17, 1994 between the Registrant and
Sloan-Kettering Institute for Cancer Research
+10.14 --Clinical Trial Agreement dated December 12, 1994 between the Registrant and
Sloan-Kettering Institute for Cancer Research
**+10.15 --QS-21 License and Supply Agreement dated August 31, 1995 between the Registrant
and Aquila Biopharmaceuticals Inc.
**+10.16 --gp120 Sublicense Agreement dated March 17, 1995 between the Registrant and Aquila
Biopharmaceuticals Inc.
**+10.17 --Cooperative Research and Development Agreement dated February 25, 1993 between
the Registrant and the Centers for Disease Control and Prevention
**+10.18 --License Agreement dated March 1, 1989, as amended by a Letter Agreement dated
March 1, 1989 and as amended by a Letter Agreement dated October 22, 1996 between
the Registrant and the Trustees of Columbia University
**+10.19 --License Agreement dated June 25, 1996 between the Registrant and The Regents of
the University of California
+10.20 --KLH Supply Agreement dated July 1, 1996 between the Registrant and PerImmune,
Inc.
</TABLE>
II-3
<PAGE>
<TABLE>
<C> <S>
**+10.21 --sCD4 Supply Agreement dated November 3, 1993 between the Registrant and E.I.
DuPont De Nemours and Company
**10.22 --Lease dated June 30, 1994 between the Registrant and Keren Limited Partnership
**11.1 --Statement of computation of loss per share for the years ended December 31, 1993,
1994 and 1995
**11.2 --Statement of computation of loss per share for the nine months ended September
30, 1995 and 1996
**11.3 --Pro forma statement of computation of loss per share
**23.1 --Consent of Coopers & Lybrand L.L.P.
**23.2 --Consent of Dewey Ballantine (contained in Exhibit 5.1)
**24.1 --Power of Attorney (included on page II-5)
**27.1 --Financial Data Schedule
</TABLE>
- ------------------------
** Previously filed.
+ Confidential treatment requested as to certain portions, which portions are
omitted and filed separately with the Commission.
(b) Financial Statement Schedules
All schedules have been omitted because they are not required or because the
required information is given in the Financial Statements or Notes thereto.
ITEM 17. UNDERTAKINGS
The undersigned Registrant hereby undertakes to provide to the underwriters,
at the closing specified in the underwriting agreement, certificates in such
denominations and registered in such names as required by the underwriters to
permit prompt delivery to each purchaser.
Insofar as indemnification for liabilities arising under the Securities Act
of 1933 may be permitted to directors, officers and controlling persons of the
Registrant pursuant to the foregoing provisions, or otherwise, the Registrant
has been advised that in the opinion of the Securities and Exchange Commission
such indemnification is against public policy as expressed in the Act and is,
therefore, unenforceable. In the event that a claim for indemnification against
such liabilities (other than the payment by the Registrant of expenses incurred
or paid by a director, officer or controlling person of the Registrant in the
successful defense of any action, suit or proceeding) is asserted by such
director, officer or controlling person in connection with the securities being
registered, the Registrant will, unless in the opinion of its counsel the matter
has been settled by controlling precedent, submit to a court of appropriate
jurisdiction the question whether such indemnification by it is against public
policy as expressed in the Act and will be governed by the final adjudication of
such issue.
The undersigned Registrant hereby undertakes that:
(1) For purposes of determining any liability under the Securities Act
of 1933, the information omitted from the form of prospectus filed as part
of this registration statement in reliance upon Rule 430A and contained in a
form of prospectus filed by the Registrant pursuant to Rule 424(b)(1) or (4)
or 497(h) under the Securities Act shall be deemed to be part of this
registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities
Act of 1933, each post-effective amendment that contains a form of
prospectus shall be deemed to be a new registration statement relating to
the securities offered therein, and the offering of such securities at that
time shall be deemed to be the initial bona fide offering thereof.
II-4
<PAGE>
SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, the Registrant
has duly caused this Amendment to the Registration Statement to be signed on its
behalf by the undersigned, thereunto duly authorized, in the City of Tarrytown,
State of New York, on November 26, 1996.
PROGENICS PHARMACEUTICALS, INC.
BY: /s/ PAUL J. MADDON, M.D., PH.D
-----------------------------------------
Paul J. Maddon, M.D., Ph.D.
Chairman of the Board,
Chief Executive Officer and President
POWER OF ATTORNEY
Pursuant to the requirements of the Securities Act of 1933, as amended, this
Amendment to the Registration Statement has been signed by the following persons
on November 26, 1996 in the capacities indicated:
SIGNATURE TITLE DATE
- ------------------------------ --------------------------- -------------------
Chairman of the Board,
* Chief Executive Officer
- ------------------------------ and President (principal November 26, 1996
Paul J. Maddon, M.D., Ph.D. executive officer)
Vice President, Finance and
* Operations, Treasurer
- ------------------------------ (principal accounting and November 26, 1996
Robert A. McKinney financial officer)
* Director
- ------------------------------ November 26, 1996
Charles A. Baker
* Director
- ------------------------------ November 26, 1996
Mark F. Dalton
* Director
- ------------------------------ November 26, 1996
Stephen P. Goff, Ph.D.
* Director
- ------------------------------ November 26, 1996
Elizabeth M. Greetham
II-5
<PAGE>
SIGNATURE TITLE DATE
- ------------------------------ --------------------------- -------------------
* Director
- ------------------------------ November 26, 1996
Paul F. Jacobson
* Director
- ------------------------------
David A. Scheinberg, M.D., November 26, 1996
Ph.D.
*By: /s/ ROBERT A. MCKINNEY
------------------------------------------
Robert A. McKinney
(As Attorney-in-Fact)
II-6
<PAGE>
INDEX TO EXHIBITS
<TABLE>
<CAPTION>
EXHIBITS DESCRIPTION PAGE
- ----------- ------------------------------------------------------------------------------------------------- ---------
<C> <S> <C>
**1.1 --Form of Underwriting Agreement
**3.1 --Certificate of Incorporation, as amended, of the Registrant
**3.2 --By-Laws of the Registrant
**4.1 --Specimen Certificate for Common Stock, $.0013 par value per share, of the Registrant
**5.1 --Opinion of Dewey Ballantine
**10.1 --Form of Registration Rights Agreement
**10.2 --1989 Non-Qualified Stock Option Plan
**10.3 --1993 Stock Option Plan as amended
**10.4 --1993 Executive Stock Option Plan
**10.5 --Amended 1996 Stock Incentive Plan
**10.6 --Form of Indemnification Agreement
**10.7 --Employment Agreement dated December 15, 1993 between the Registrant and Dr. Paul J. Maddon
**10.8 --Letter dated August 25, 1994 between the Registrant and Dr. Robert J. Israel
**10.9 --Sublease dated July 13, 1988 between the Registrant and Union Carbide Corporation
+10.10 --gp120 Supply Agreement dated July 19, 1995 between the Registrant and E. I. DuPont De Nemours
and Company, as amended, October 27, 1995
+10.11 --sCD4 Supply Agreement dated June 27, 1995 between the Registrant and E. I. DuPont De Nemours
and Company
**+10.12 --Supply Agreement dated February 8, 1996 between the Registrant and Intracel Corporation
**+10.13 --License Agreement dated November 17, 1994 between the Registrant and Sloan-Kettering Institute
for Cancer Research
+10.14 --Clinical Trial Agreement dated December 12, 1994 between the Registrant and Sloan-Kettering
Institute for Cancer Research
**+10.15 --QS-21 License and Supply Agreement dated August 31, 1995 between the Registrant and Cambridge
Biotech Corporation
**+10.16 --gp120 Sublicense Agreement dated March 17, 1995 between the Registrant and Cambridge Biotech
Corporation
**+10.17 --Cooperative Research and Development Agreement dated February 25, 1993 between the Registrant
and the Centers for Disease Control and Prevention
**+10.18 --License Agreement dated March 1, 1989, as amended by a Letter Agreement dated March 1, 1989 and
as amended by a Letter Agreement dated October 22, 1996 between the Registrant and the Trustees
of Columbia University
**+10.19 --License Agreement dated June 25, 1996 between the Registrant and The Regents of the University
of California
+10.20 --KLH Supply Agreement dated July 1, 1996 between the Registrant and PerImmune, Inc.
**+10.21 --sCD4 Supply Agreement dated November 3, 1993 between the Registrant and E.I. DuPont De Nemours
and Company
**10.22 --Lease dated June 30, 1994 between the Registrant and Keren Limited Partnership
**11.1 --Statement of computation of loss per share for the years ended December 31, 1993, 1994 and 1995
</TABLE>
<PAGE>
<TABLE>
<C> <S> <C>
**11.2 --Statement of computation of loss per share for the nine months ended September 30, 1995 and
1996
**11.3 --Pro forma statement of computation of loss per share
**23.1 --Consent of Coopers & Lybrand L.L.P.
**23.2 --Consent of Dewey Ballantine (contained in Exhibit 5.1)
**24.1 --Power of Attorney (included on page II-5)
**27.1 --Financial Data Schedule
</TABLE>
- ------------------------
** Previously filed.
+ Confidential treatment requested as to certain portions, which portions are
omitted and filed separately with the Commission.
<PAGE>
Exhibit 10.10
gp120 SUPPLY AGREEMENT
This Agreement, dated as of the 19th day of July, 1995, is between
E. I. DU PONT DE NEMOURS AND COMPANY, a Delaware corporation with
a place of business at 549 Albany St., Boston, MA 02118
("DUPONT"), and PROGENICS PHARMACEUTICALS, INC., a Delaware
corporation with its principal place of business at Old Saw Mill
River Road, Tarrytown, New York 10591 ("PROGENICS").
1. PURPOSE AND SCOPE OF THIS AGREEMENT
A. During the term hereof, PROGENICS will manufacture and sell to DUPONT,
and DUPONT shall purchase from PROGENICS, all of DUPONT's requirements for
resale of recombinant HIV-1LAI gp120 (full length) produced in a CHO
expression system (the "Product") for DUPONT's marketing, distribution and
resale throughout the world. DUPONT will limit sales to customers who intend
to use the Product only for research purposes and not for other purposes such
as clinical diagnostics or vaccine development.
B. DUPONT will resell the Product as packaged by PROGENICS, and DUPONT
will not modify the Product or combine it with other components prior to
resale.
C. PROGENICS has developed Product specifications for the Product which
are attached as Exhibit A. All PROGENICS manufacturing of Product will comply
with the Product processing standards and specifications. PROGENICS may
revise the processing standards and specifications as it deems necessary and
will advise DUPONT as far in advance of any changes as is reasonably
possible. If any change affects customer use or perceived performance of the
Product, PROGENICS will give DUPONT at least 90 days advance notice of such
change.
D. PROGENICS will package the Product under specifications established
by DUPONT with PROGENICS' consent. Both DUPONT's and PROGENICS' names shall
appear on the Product label and promotional material, with the statement
"Manufactured by Progenics Pharmaceuticals, Inc. for E. I. du Pont de
Nemours and Company." All Product labeling and literature shall contain the
phrase "For laboratory use only--not for vaccine or diagnostic use." Any
labeling changes will require the prior approval of DUPONT.
<PAGE>
2. IMPROVED PRODUCTS
A. If during the term hereof PROGENICS develops an improved Product and
the commercialization of the improved Product reaches the market evaluation
stage, PROGENICS will give DUPONT written notice of its plans to
commercialize the improved Product and offer to make available, at DUPONT's
cost, sample of the improved Product for DUPONT's evaluation, but as testing
materials only and not under circumstances that would commit PROGENICS or
DUPONT to supply the improved Product or give customers an expectation that
the improved Product will be commercialized. DUPONT may elect to add the
improved Product to this Agreement at any time, subject to provisions of
Paragraph 2-B below. The parties intend that DUPONT will have advance notice
of the introduction of improved Product to enable DUPONT to sell remaining
inventory of Product that may be replaced by the improved Product.
B. PROGENICS may discontinue a Product that has, in PROGENICS' sole
opinion, been replaced by an improved Product. If PROGENICS decides to
discontinue a Product, PROGENICS will give DUPONT notice at least 90 days in
advance of the discontinuance.
3. PRICE AND FORECASTING
A. DUPONT will pay PROGENICS for Product as follows:
1. RAW MATERIALS COST DUPONT will pay PROGENICS for the
Product raw material cost at [***]
2. REVENUE SHARING [***] to DUPONT on resale of Product will be paid to
PROGENICS, 1) reduced by [***] and 2) increased by [***].
An example of Revenue Sharing is attached hereto as Exhibit B for
purposes of illustration. DUPONT will provide worldwide Product
sales reports each April and October during the term hereof.
PROGENICS shall, on the basis of such reports, calculate the revenue
sharing for such six-month period and invoice DUPONT for the amount
owing. Such invoices shall include documentation of the method of
establishing the amount owning. For purposes of revenue sharing,
[***]
3. LARGE VOLUME PURCHASERS DUPONT may negotiate special pricing
with large volume purchasers, in which event the parties shall
negotiate in good faith a discounted raw materials cost. In no
event shall the PROGENICS price to DUPONT be less than [***]
2
[***] Confidential Treatment Requested
<PAGE>
All prices are F.O.B. PROGENICS' plant. PROGENICS assumes all risks and costs
of freight, insurance and similar shipping costs.
B. The raw material prices stated in Paragraph 3-A may be revised by
PROGENICS from time to time during the term hereof on at least 90 days'
advance written notice to DUPONT.
C. On execution of this Agreement and then on a semi-annual basis
during the term of this Agreement, DUPONT will provide to PROGENICS a written
non-binding forecast by month for purchases of Product by DUPONT during each
month of the succeeding twelve months.
4. ORDERS FOR PRODUCT AND PAYMENT
A. At least once each year during the term of this Agreement, DUPONT
will issue a Blanket Purchase Order for anticipated Product purchases. DUPONT
will then issue releases against the Blanket Purchase Order, on at least a
monthly basis, at least 30 days in advance of the requested ship date.
Releases will be firm orders.
B. PROGENICS will manufacture and ship the Product to DUPONT within
ten days of DUPONT's requested ship date. On shipment of an Order, PROGENICS
will invoice DUPONT for the raw material cost of the Product.
C. DUPONT will pay PROGENICS within 30 days of DUPONT's receipt of a
correct PROGENICS invoice.
D. DUPONT may request manufacture of Product using its standard
purchase order forms or other written means (an "Order"). Purchases under
this Agreement will be governed by the provisions of this Agreement, rather
than the standard terms and conditions of DUPONT's purchase order form or any
PROGENICS form.
5. QUALITY CONTROL, REJECTION OF NONCONFORMING
PRODUCTS AND NOTICE OF CUSTOMER COMPLAINTS
A. PROGENICS and DUPONT agree to exchange sufficient quality and
Product release information to avoid duplication of testing of Product.
PROGENICS and DUPONT will mutually agree on the types and amounts of
information needed to reach this goal.
B. PROGENICS will manufacture Product in accordance with the
specification attached in Exhibit A and any amendments to Exhibit A. DUPONT
may return any defective or nonconforming Product to PROGENICS. Nonconformance
will mean any failure to meet specification or other manufacturing defect
that renders the
3
<PAGE>
Product unsuitable for sale or use. Risk of loss and expenses incurred in
shipping any defective or nonconforming Product to PROGENICS will be borne by
PROGENICS with a direct reimbursement to DUPONT or, at DUPONT's option,
credit on subsequent purchases.
C. DUPONT will notify PROGENICS of any customer complaint about a
Product or Improved Product defect within ten days of confirmation of the
defect. The notice will specify the Product and type of defect.
6. LIMITED WARRANTY AND LIMITATION OF REMEDIES
A. PROGENICS warrants to DUPONT that all Product meets the
specifications stated in Exhibit A and is free of defects in Material and
manufacture at the time of shipment. If any Product is proven to be defective
in material or manufacture, PROGENICS' entire liability and DUPONT's
exclusive remedy will be, at PROGENICS' option, either replacement of the
Product, or refund of the purchase price paid by DUPONT for the defective
Product, within a reasonable time after written notification of the defect
and return of the defective Product to PROGENICS. Notices of defect must be
received by PROGENICS within 60 days of DUPONT's receipt of notice of a
defect from the customer.
B. THE WARRANTY STATED IN PARAGRAPH 6-A IS MADE IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED
WARRANTY OF MERCHANTABILITY, THE IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE, ANY IMPLIED WARRANTY ARISING OUT OF A COURSE OF DEALING OR OF
PERFORMANCE, CUSTOM OR USAGE OF TRADE, EXCEPT OF TITLE AND AGAINST PATENT
INFRINGEMENT.
C. PROGENICS has no obligations under this warranty with respect to
Products that have been modified or damaged through misuse, abuse, accident,
neglect, improper storage or mishandling by DUPONT, or if DUPONT holds Product
in storage beyond the natural age of the Product.
D. PROGENICS warrants and represents that (i) Product does not constitute
the subject matter of any currently pending litigation and PROGENICS is not
aware as of the effective date of this Agreement of any litigation
contemplated by PROGENICS or any other third party with respect to the
subject matter of this Agreement and (ii) sale and use of Product will not
infringe any third party patents and that any patent rights necessary for
DUPONT and its customers to use and sell Product have been acquired by
PROGENICS. No warranty or representation is made with respect to use of
Product for purposes other than research or for use in combination with other
products.
4
<PAGE>
7. LIMITATION OF LIABILITIES: TIME LIMIT FOR FILING ACTION
A. Subject to the indemnity provisions set forth below, NEITHER PARTY
WILL UNDER ANY CIRCUMSTANCES BE LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL,
SPECIAL OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, LOSS OF
PROFITS, REVENUE OR BUSINESS) RESULTING FROM OR IN ANY WAY RELATED TO THE
PRODUCTS, ANY OF DUPONT'S PURCHASE ORDERS, THIS AGREEMENT, OR, THE
TERMINATION OR NONRENEWAL OF THIS AGREEMENT. This limitation applies
regardless of whether the damages are sought based on breach of warranty,
breach of contract, negligence, strict liability in tort, or any other legal
theory.
B. Any action for breach of warranty or any other obligation under
this Agreement must be commenced within one year after the breach occurs.
8. INDEMNIFICATION
A. PROGENICS agrees to indemnify, defend and hold harmless DUPONT from any
cost, loss, claim, liability and expense (including reasonable attorney's fees
and expenses of litigation) by third parties for property damage, personal
injury or death to the extent based on PROGENICS' breach of this Agreement or
on PROGENICS' negligence with respect to manufacture of the Product.
B. PROGENICS will defend DUPONT at PROGENICS' cost and expense,
including reasonable attorney's fees, against any claim or suit for
infringement of patent brought against DUPONT to the extent the claim
concerns the Product. In addition, PROGENICS will indemnify DUPONT against
any judgment awarded in such a suit, provided that DUPONT gives PROGENICS
prompt written notice of the claim, the right to maintain sole control of the
defense and all negotiations for settlement of the claim or suit, and
cooperates with PROGENICS if requested in the defense of the claim of suit.
C. DUPONT agrees to indemnify, defend and hold harmless PROGENICS from
any cost, loss, claim, liability and expense (including reasonable attorney's
fees and expenses of litigation) by third parties for property damage,
personal injury or death to the extent based on DUPONT's breach of this
Agreement or on DUPONT's negligence with respect to sale or distribution of
the Product.
D. (i) DUPONT will promptly advise PROGENICS in writing of any claim of
infringement and of the commencement against it of any claim for infringement
of a patent issued to a third party based upon the sale of any Product.
PROGENICS will, if promptly requested in writing to do so, and subject to the
other conditions and limitations of this Section, defend any such lawsuit.
5
<PAGE>
(ii) PROGENICS shall have the control of the defense of such lawsuit.
DUPONT agrees to assist PROGENICS in the defense of such suit or action by
providing information and, if need be, fact witnesses. DUPONT shall have the
right to be represented by its own attorneys at DUPONT's own expense, which
attorneys will act only in an advisory capacity.
(iii) If PROGENICS is requested to defend a lawsuit as described above,
PROGENICS will defend DUPONT for any damages and costs that may become
payable under a final judgment or decree by any court in such lawsuit.
(iv) Nothing herein shall authorize PROGENICS to settle any lawsuit
without the consent of Licensee, if by such settlement DUPONT is obligated to
make any monetary payment, to transfer any property or any interest in
property, to become subject to an injunction, or to grant any license or
other rights under its intellectual property rights.
(v) If DUPONT is unable to dispose of any inventory due to infringement of
third party patent, then PROGENICS shall provide DUPONT with a credit equal
to the amount of inventory which DUPONT cannot dispose of due to infringement
of a third party patent.
9. CONFIDENTIALITY AND PATENT RIGHTS
A. DUPONT will treat as confidential information and not disclose to
third persons or use for its own benefit or the benefit of others, any of
PROGENICS' developments, business knowledge, know-how, discoveries (including
PROGENICS' Product formula, processing standards, specification, test
procedures and other information concerning the design, composition and
method of manufacture of the Product) and other confidential or proprietary
information which may be disclosed to DUPONT in writing or confirmed in
writing and specifically designated as "confidential".
B. The obligation of nondisclosure and non-use set forth above shall
not apply to any items which:
1. Are available to the public or become available to the public through
no fault of the recipient;
2. are known by the recipient at the time of disclosure, as shown by
prior written records;
3. are rightfully received by the recipient from a third party without
a duty of nondisclosure; or
4. are developed by or for the recipient independent of the disclosure
hereunder, as evidenced by the recipient's written records relating
thereto.
The obligation of nondisclosure and non-use set forth above shall continue for
a period of five years from disclosure, notwithstanding any earlier
termination of this Agreement.
6
<PAGE>
E. Neither party acquires any intellectual property rights or licenses
under this Agreement, or rights to use confidential information disclosed to
it hereunder for purposes other than complying with its obligations hereunder.
10. TERM AND TERMINATION
A. This Agreement commences on the date first above written and
continues unless and until either party gives the other at least 120 days
advance written notice of termination.
B. Either party may terminate this Agreement if the other party
breaches this Agreement by giving 30 days prior written notice, subject,
however, to the other party's right to cure the breach within the notice
period.
C. Even after termination, the provisions of this Agreement still
apply to all Product ordered, purchased and manufactured, all obligations
created or arising, and all transactions and events occurring before the date
of termination.
11. NOTICES
A. All notices required by this Agreement must be in writing and sent by
certified mail, with return receipt requested, Federal Express or other
overnight service. The date of a notice is the date it is received. A
facsimile copy of any notice shall be sent in addition to the written notice
herein specified.
B. DUPONT will send all notices under this Agreement to:
Attn.: CEO
Progenics Pharmaceuticals, Inc.
Old Saw Mill River Road
Tarrytown, NY 10591
Telex (914) 789-2817
C. PROGENICS will send all notices under this Agreement to:
Attn.: Product Manager
DuPont Medical Products
549 Albany Street
Boston, MA 02118
Telex (617) 542-8463
D. A party may designate in writing other individuals or locations to
receive notice.
7
<PAGE>
12. DISPUTE RESOLUTION
A. The parties agree to attempt in good faith to resolve any dispute
arising out of or relating to this Agreement promptly by negotiations.
1. Either party may give the other party written notice of any
dispute not resolved in the normal course of business. Executives
of both parties at levels one step above the project personnel who
have previously been involved in the dispute will meet at a
mutually acceptable time and place within ten days after delivery
of the notice, and thereafter as often as they reasonably deem
necessary. The purpose of this meeting is for the executives to
exchange relevant information and to attempt to resolve the
dispute.
2. If the matter has not been resolved by the executives within 30
days of the notice, or if the parties fail to meet within the ten
day period, the dispute will be referred to senior executives of
both parties who have authority to settle the dispute to attempt
to resolve the dispute. If the matter has not been resolved within
30 days from the referral of the dispute to the senior executives,
or if no meeting has taken place within 15 days after referral to
the senior executives, either party may initiate mediation or
other mutually agreed to alternate dispute resolution mechanism.
3. If the dispute has not been resolved by negotiation as stated
above, the parties agree to attempt to settle the dispute by
mediation using a third party neutral; provided however, that if
the dispute has not been resolved within ninety (90) days of the
initial notice of dispute for whatever reason, either party may
pursue such judicial relief as it deems appropriate.
B. The procedures stated in Paragraph 12-A will be the sole and
exclusive procedures for the resolution of disputes between the parties
arising out of or relating to this Agreement. A party, however, may seek a
preliminary injunction or other provisional judicial relief if in its
judgment such action is necessary to avoid irreparable damage or to preserve
the status quo. Despite such action the parties will continue to participate
in good faith in the procedures specified in this Paragraph 12.
C. Any questions, claims, disputes or litigation arising from or related
to this Agreement are governed by the law of the state of New York, without
regard to the principles of conflicts of law.
7
<PAGE>
13. GENERAL TERMS
A. No liability shall result from delay in performance, or
nonperformance, caused by circumstances beyond the control of the party
affected, including without limitation Act of God, fire, flood, war,
government action, riot, civil disturbance, accident, inability to obtain
labor, material, equipment or transportation. Quantities so affected by force
majeure may be eliminated without liability, but the Agreement shall remain
otherwise unaffected.
B. The relationship of the parties under this Agreement is that of
independent contractors. Nothing in this Agreement authorizes either party to
act for the other as an agent.
C. Neither party may assign any of its rights or delegate or
subcontract any of its duties under this Agreement without first getting the
other party's permission in writing. Notwithstanding the foregoing,
assignment and delegation may be made by either party hereto without such
prior permission in connection with the transfer by such party of the
business to which this Agreement relates.
D. This Agreement represents the entire agreement of the parties, and
supersedes any and all prior agreements, conversations and understandings
between the parties hereto with respect to the subject matter hereof. No
modification of its provisions shall be valid unless it is in writing and
signed by both parties. The provisions of this Agreement are severable. If
any provision herein violates or anywhere contravenes any applicable law, it
shall not be deemed a part of this Agreement.
C. This Agreement shall be interpreted in accordance with the laws of
New York.
ACCEPTED AND AGREED TO:
PROGENICS PHARMACEUTICALS, INC. E.I. DU PONT DE NEMOURS
AND COMPANY
By: Paul J. Maddon By: Janet J. Seal
- --------------------------- ----------------------------
Title: Chairman & CEO Title: Non Business District
8
<PAGE>
PROGENICS
Sheet 1
[***]
Page 1
[***] Confidential Treatment Requested
<PAGE>
PROGENICS
[LOGO] [LETTERHEAD]
PRODUCT SPECIFICATION SHEET
PRODUCT: Recombinant HIV-1LAI gp120
PRODUCT HIV- 1LAI gp120 (full-Length)
DESCRIPTION: produced in a CHO expression system.
STORAGE BUFFER: 20 mM Imidazole, pH 7.1; 200 mM NaCl
CONCENTRATION: 1 mg/ml
SHIP: DRY ICE
STORE: -80DEG. C
STABILITY: 6 months at -80DEG. C
QUALITY CONTROL
- ---------------
CONCENTRATION Determined by BCA and
AND PURITY: SDS-PAGE/Silver stain (Purity > 95%)
AUTHENTICITY: Reactive with recombinant human soluble CD4 and
anti-gp120 antibodies
Mammalian cell glycosylation pattern.
ACTIVITY: Binds recombinant human soluble CD4 with an
affinity of 1.7 nM.
FOR LABORATORY USE ONLY
NOT FOR VACCINE OR DIAGNOSTIC USE
<PAGE>
[LOGO]
[LETTERHEAD]
E.I. DU PONT DE NEMOURS & CO. (INC.)
MEDICAL PRODUCTS DEPARTMENT
Reference is made to the Agreement entered into the 19th day of July, 1995,
as amended between E.I. DuPont de Nemours and Company (DuPont) and Progenics
Pharmaceuticals, Inc. (Progenics) relative to the purchase of HIV-1 (LAI)
gp120 by DuPont. It is hereby mutually agreed to further amend the aforesaid
Agreement in the following manner effective August 24, 1995.
This amendment is being made to update specifications, extending stability
from 6 months at -80DEG. C to 12 months from date of
purification/repurification. Hence a new Product specification
Exhibit A is attached, dated and effective August, 1995.
This amendment is also being made to update the "Orders for Product and
Payment" clause, to include Progenics' agreement to supply DuPont Product
with at least nine (9) months shelf life upon receipt by DuPont.
All other terms and conditions of the current Agreement, except as modified
in the above manner, shall continue in full force and effect. Please indicate
your acceptance of this amendment by signing both copies in the space
provided below and return the copy marked "DuPont M&L Copy" to Robert Hand,
DuPont Merck Pharmaceutical Co., Purchasing Department, 331 Treble Cove Road,
Billerica, MA 01862.
Very truly yours,
PROGENICS PHARMACEUTICALS, INC. E.I. DUPONT de NEMOURS & CO.
BY: /s/ Paul J. Maddon BY: /s/ R.M. Hand
- -------------------------------- ----------------------------
TITLE: Chief Executive Officer TITLE: Sr. Purchasing Agent
- -------------------------------- ----------------------------
DATE: October 27, 1995 DATE: September 10, 1995
- -------------------------------- ----------------------------
Attach.
<PAGE>
MATERIALS SPECIFICATION SHEET
(PURCHASED MATERIALS)
DESCRIPTION: Recombinant HIV-1 LAI gp 120
DUPONT PART#: NEA201001EA
- -------------------------------------------------------------------------------
SPECIFICATIONS TEST/APPROVAL CRITERIA
- -------------------------------------------------------------------------------
PRODUCT DESCRIPTION: HIV-1 LAI gp120 (full-length)
produced in a mammalian (CHO)
express system
STORAGE BUFFER: 10mM Sodium Phosphate, 4mM Potassium
Chloride, 140mM Sodium Chloride,
pH 7.1
CONCENTRATION: 1.0 + or - 0.1 mg/mL
AMOUNT: 100 ug per vial
SHIP: Dry ice
STORE: - 80DEG. C
STABILITY: 12 months at -80DEG. C from date of
Purification/Repurification
- -------------------------------------------------------------------------------
QUALITY CONTROL TEST/APPROVAL CRITERIA
- -------------------------------------------------------------------------------
CONCENTRATION AND PURITY: Determine by BCA and SDS-PAGE/Silver
stain (Purity > 95%)
AUTHENTICITY: Reactive with recombinant human
soluble CD4 and anti-gp 120
antibodies; Mammalian cell
glycosylation pattern
ACTIVITY: Binds to recombinant human soluble CD4
(Kd < 10nM)
NEA201-0995 SUPERCEDES: 081895
<PAGE>
Exhibit 10.11
[LOGO]
E.I. DU PONT DE NEMOURS & CO. (INC.)
MEDICAL PRODUCTS DEPARTMENT
This document, when properly executed, shall constitute a Supply
Agreement between Progenics Pharmaceuticals, Inc. with offices at
Old Saw Mill River Road, Tarrytown, NY, (Progenics) and
E.I. DuPont de Nemours and Company (DuPont), with offices at
549 Albany Street, Boston, MA.
1. PERIOD OF AGREEMENT:
May 1, 1995 through April 30, 1998. After the original term, this
Agreement will renew automatically for successive 12 month periods
unless either party gives notice to the other of its intention not to
renew at least 120 days prior to the expiration of the then current
term.
2. MATERIAL:
Recombinant Soluble sCD4, referred to hereafter as sCD4 or Product.
3. MATERIAL SPECIFICATIONS:
Material shall be suppled in the form and manner, and must conform in
all material respects to the specifications set out in Attachment A.
Alterations to these specifications require the express written
consent of each party.
4. INABILITY TO SUPPLY:
Progenics recognizes the importance of its obligation to meet DuPont's
material requirements in a timely and reliable manner. To enable such
continuity of supply, Progenics will use its best efforts to arrange
for sCD4 to be manufactured on Progenics' behalf if some unusual event
causes Progenics' inability to supply. If at any time, Progenics for a
continuous period of ten (10) days due to a force majeure event, or
non-force majeure event, shall be unable or unwilling to deliver any
Product subject to this Agreement and attachments hereto, then
Progenics shall notify DuPont of the situation and use its best
efforts to arrange for sCD4 to be manufactured to DuPont's material
requirements hereunder. In the event that the failure to deliver sCD4
shall be as a result of the fault of Progenics, then Progenics shall
bear all costs necessary to cause the sCD4 to be manufactured by
another party ("Alternate Manufacturing Cost").
MEDICAL PRODUCTS DEPARTMENT
549 Albany Street, Boston, Massachusetts 02118 Telephone 617-482-9595
Fax (617) 542-8468
<PAGE>
2
INABILITY TO SUPPLY (Cont'd):
In the event that the failure to deliver sCD4 shall be as a result of the
fault of DuPont, then DuPont shall bear all Alternate Manufacturing
Costs. In all other events, Progenics shall arrange for the alternate
manufacturer and each party shall bear its own costs. If Progenics
corrects the cause for alternate manufacture, then Progenics may
resume production of affected Product at any time.
5. PRICE AND ROYALTIES
Cost/mg Royalty Rate
------- ------------
[***] [***]
6. PAYMENT TERMS:
Net 30 days, following the receipt of a properly prepared and correct
invoice.
7. QUANTITY:
DuPont commits to purchase 100% of its purchase requirements for sCD4
during the term of this order from Progenics, and Progenics agrees to
supply 100% of DuPont's purchase requirements.
8. DELIVERY TERMS:
F.O.B. Destination, freight pre-paid and added.
9. RELEASE:
DuPont will advise Progenics of its purchase requirements at least
quarterly, or as may otherwise suit the parties by agreement.
Progenics shall ship product as required by DuPont according to a
mutually agreed upon schedule. Progenics shall advise DuPont at its
earliest opportunity if it is unable to ship Product at an agreed upon
time. Progenics will, on a best effort basis, attempt to fulfill any
unscheduled, or spot requirements of DuPont.
10. LABELLING AND SHIPPING:
Progenics' name and logo will appear on the main kit label (not on
components) on manual and on promotional literature, along with
DuPont's. All labels to be approved by both parties.
Product will be shipped Federal Express Priority I on dry ice. In
parallel, Progenics will perform stability studies on lyophilized
product. Shelf life of the sCD4 will be no less than 6 months upon
receipt by DuPont.
[***] Confidential Treatment Requested
<PAGE>
3
11. CONFIDENTIALITY:
The parties hereto shall keep confidential all confidential technical
information, supplied by one party to the other, shall not disclose or
make known to any individual, firm, or corporation, except when
authorized in writing to do so by the other party, and shall not use
such information for any purpose other than the performance of the
obligations provided in this Agreement. The provisions of this clause
shall remain binding for five (5) years after the termination of this
Agreement.
Each party shall use the same degree of care to avoid disclosure of
confidential technical information as the party employs with similar
information of its own which it does not desire to publish or disclose.
Any confidential information shared between the parties must be
identified and labeled in writing as confide
ntial. The confidentiality
of and information disclosed verbally must be identified in writing as
confidential no more than 14 days after disclosure.
This obligation shall not apply to information and/or documents which:
A) Are or come within the public domain otherwise than as
a consequence of a breach of the obligations
hereunder;
B) Are known to the receiving party prior to disclosure by
the other party as shown by the receiving party's
records;
C) Are lawfully disclosed to the receiving party by third
parties; or
D) Are subsequently independently developed by the
receiving party through no reference whatsoever to
disclosure hereunder.
12. WARRANTY:
Progenics warrants and guarantees that DuPont will not be subject to
any patent infringement with respect to sDC4 supplied by Progenics as
set forth in paragraph 14. In addition, Progenics warrants and
represents that it shall convey good and valid title to material(s)
supplied
<PAGE>
4
WARRANTY (Cont'd):
hereunder and that material(s) supplied hereunder shall meet all of
the specifications set forth in Attachment A and shall be free from
defects except those caused by misuse or mishandling occurring after
such delivery. Progenics shall notify DuPont prior to making any
formulation changes in the Product. Progenics further warrants that
packaged product will meet the warranty of merchantability and fitness
for intended use. In the event of a recall of Product, Progenics
agrees to reimburse DuPont for all reasonable costs incurred in the
recall.
13. USE OF MATERIAL:
Progenics as a co-exclusive licensee to a family of patents owned by
Columbia University covering the CD4 gene and protein, will supply
DuPont with quantities of sCD4 necessary to meet market demands.
DuPont shall be entitled to use such sCD4 supplied by Progenics for
the manufacturing of drug screening kits to be sold by DuPont to third
parties.
14. PATENTS:
Progenics, Biogen, Inc. and Genentech, Inc. each hold a worldwide
co-exclusive license from Columbia University to make, have made, use
and sell sCD4 gene and protein under [***] and all divisional,
continuation, continuation-in-part applications thereof, any patent
granted on any aforesaid patent application, and any extension, reissue,
or reexamination of any patents that may issue thereon as well as any
foreign counterparts thereof. Progenics also holds a [***]
Progenics shall defend any suit or proceeding brought against DuPont
based on a claim that materials or services purchased hereunder, or
any part thereof, furnished by Progenics under this Agreement
constitutes an infringement of any patent, copyright, or other
proprietary right of any third party provided Progenics is notified
promptly in writing and given authority, information, and assistance
by DuPont to defend such suits or proceedings.
*** Confidential Treatment Requested
<PAGE>
5
PATENTS (Cont'd):
Progenics shall assume the responsibility to pay all costs, to
include such reasonable attorney fees of defending such suits or
proceeding and any damages that may be awarded therein against DuPont,
to settle any such claim on such terms and conditions it deems
advisable. In case the materials purchased hereunder, or any part
thereof, is in such suit or proceeding held to constitute infringement
or any patent, copyright, or other proprietary right of any third
party, and the use thereof is enjoined, or the settlement made
requires the use of services or materials purchased hereunder to be
discontinued, Progenics shall, at its own expense, and its option,
either procure for DuPont the right to continue using such materials
or services, replace the same with non-infringing materials which
conform to the available specifications, modify such materials or
services in a manner acceptable to DuPont so it becomes
non-infringing, or terminate this Agreement.
15. RELATIONSHIP OF THE PARTIES:
Nothing contained herein shall be construed to empower either party
to act as agent for the other. The parties agree that each of them
shall, in relation to its obligations hereunder, be acting as an
independent contractor.
RELATIONSHIP OF THE PARTIES (Cont'd)
Notwithstanding, neither party shall, during the period of this
Agreement, enter into discussions nor create an alternative
arrangement with any third party concerning the subject matter herein,
without first advising the other party of its intent.
16. ASSIGNMENT AND SUBCONTRACTING:
Neither party shall assign or transfer this Agreement, in whole or in
part, or any interest arising under this Agreement or subcontract any
work hereunder without the prior written consent of the other party.
Subject to the provisions of this clause, this Agreement shall insure
the benefit of and be binding upon the successors and assigns of the
parties.
17. DOCUMENTS/COMMUNICATIONS:
Purchase Order Number(s), Line Number(s), and Release Number(s) are
to appear on all paper work such as packing lists, invoices and
correspondence. Also, Certificates of Analysis (C.O.A.) shall be
submitted to DuPont by Progenics for each lot shipped by Progenics.
<PAGE>
6
18. NOTICES:
Any notices to be given hereunder shall be given in writing and shall
be deemed to have been validly given when deposited in the United
States mail, properly stamped and addressed to DuPont or Progenics,
whichever the case may be, at the addresses shown below or at such
other address as may from time to time be designated by such party in
a notice to the other party.
Progenics: Progenics Pharmaceutical, Inc.
Old Saw Mill River Road
Tarrytown, NY 10591
Attn: Joel Sendek
DuPont: E.I. DuPont de Nemours and Company
Medical Products Department
549 Albany Street
Boston, MA 02118
Attn: Judith Lima-Ziegler
Materials/Inventory Supervisor
19. NONDISCRIMINATION:
Progenics warrants that it has complied with all applicable laws,
rules, orders and regulations of governmental authority covering the
production, sale and delivery of the Product specified herein,
including, but not limited to, Executive Order 11246, and the rules
and regulations promulgated thereunder, the Rehabilitation Act of 1973
and the Vietnam Era Veterans Readjustment Act of 1974. Further, Progenics
warrants that in the performance of the services hereunder, it will
comply with all applicable provisions of the Fair Labor Standards Act
of 1938, as amended.
20. AUDITS:
Progenics shall permit no less frequently than once per year, and
upon reasonable notice by DuPont, inspections and audits by DuPont
during regular business hours of all records and aspects of sCD4
manufacture, testing, packaging, labelling and shipping.
21. CANCELLATION:
This Agreement may be cancelled by either party upon 120 days written
notice to the other party.
<PAGE>
7
22. ENTIRETY:
This Agreement, together with the Attachments specifically referenced
and attached hereto, embodies the entire understanding between DuPont
and Progenics, and there are no contracts, warranties, or
representations, oral or written, express or implied, with reference
to the subject matter hereof which are not merged herein. Except as
otherwise specifically stated, no modification hereto shall be of any
force or effect unless reduced to writing and signed by both parties
and expressly referred to as being modifications of this Agreement.
AGREED & APPROVED:
FOR PROGENICS: FOR DUPONT:
Name: Paul J. Maddon, M.D., Ph.D. Name: Robert M. Hand
Title: CEO and Scientific Dir. Title: Sr. Purchasing Agent
Signature: /s/ Paul J. Maddon Signature: /s/ Robert M. Hand
Date: June 27, 1995 Date: June 8, 1995
<PAGE>
Exhibit 10.14
CLINICAL TRIAL AGREEMENT
THIS AGREEMENT is made and entered into as of the 12th day of December,
1994 (hereinafter "Effective Date") by and between
SLOAN-KETTERING INSTITUTE FOR CANCER RESEARCH and its affiliate,
MEMORIAL HOSPITAL FOR CANCER AND ALLIED DISEASES, both having a principal
place of business at 1275 York Avenue, New York, New York 10021, membership
corporations of the State of New York (hereinafter "SKI/MEMORIAL") and
ACTIVE BIOTHERAPIES, INC., a corporation of the State of Delaware
having its principal place of business at 777 Old Saw Mill River Road,
Tarrytown, New York 10591, (hereinafter "ABI").
WITNESSETH
WHEREAS, SKI/MEMORIAL has established and maintains a Clinical
Immunology Service, a Division of Hematologic Oncology, in the Department of
Medicine and has acquired expertise in conducting research investigations,
clinical trials and laboratory test evaluations; and
WHEREAS, ABI conducts business in the development, manufacture and sale
of therapeutic products; and
WHEREAS, ABI desires SKI/MEMORIAL to conduct a clinical trial to
determine the safety and efficacy of GM2 covalently attached to KLH plus the
immunological adjuvant QS-21 in patients with melanoma (hereinafter "GM2-KLH
conjugate"), said trial entitled
VACCINATION OF MELANOMA PATIENTS WITH GM2 COVALENTLY ATTACHED TO KLH
(GM2-KLH) PLUS THE IMMUNOLOGICAL ADJUVANT QS-21: TRIAL COMPARING DOSES OF
GM2-KLH
(hereinafter the "Study").
NOW, THEREFORE intending to be legally bound and upon the terms,
conditions and covenants hereinafter set forth, SKI/MEMORIAL and ABI agree as
follows:
ARTICLE I - THE STUDY
1.1 The Study under this Agreement will be conducted under the protocol
approved by SKI/MEMORIAL's Human Subject Institutional Review Board
(hereinafter "IRB"), based on the protocol annexed hereto as Exhibit A
(hereinafter "Protocol"). SKI/MEMORIAL shall submit the Protocol for approval
to the IRB. ABI shall supply Study drug after ABI has:
1
<PAGE>
a. received a mutually executed copy of this Agreement;
b. received documentation from the Office of Industrial Affairs that
SKI/MEMORIAL's IRB has approved the Protocol;
Promptly after SKI/MEMORIAL's IRB has approved the final Protocol, the
Principal Investigator shall forward a copy to the Office of Industrial
Affairs, and the Office of Industrial Affairs shall forward a copy to ABI.
The Principal Investigator shall also forward to the Office of Industrial
Affairs any subsequent change to the Protocol, and the Office of Industrial
Affairs shall forward the change to ABI.
1.2 As part of this Agreement, SKI/MEMORIAL shall appoint Dr. Paul B.
Chapman and/or such other physicians as it may deem appropriate as
investigators (hereinafter "Investigators") to oversee the Study. If Dr.
Chapman should become unable to complete the Study, SKI/MEMORIAL shall
consult with ABI regarding the appointment of a new principal investigator.
SKI/MEMORIAL will negotiate in good faith to select a new principal
investigator so that the Study can continue.
1.3 The Investigators on behalf of SKI/MEMORIAL shall prepare and
maintain records and case histories with all pertinent data documented as
required by the Protocol on case report forms supplied by ABI. All patient
data shall be kept confidential. Information provided to ABI shall not
disclose patient names, except to the extent that the patient consent form
permits.
1.4 The Investigators shall also immediately notify ABI of any adverse
reaction in the course of the Study of which they become aware.
1.5 All applicable government laws, rules, regulations and guidelines,
including those of the United States Food and Drug Administration
(hereinafter the "FDA"), shall be adhered to by SKI/MEMORIAL and ABI in the
performance and documentation of the Study.
1.6 ABI shall provide SKI/MEMORIAL with any investigational protocols,
pre-clinical or background information which are germane to the Study.
1.7 ABI shall provide, without cost to SKI/MEMORIAL, sufficient
amounts of its GM2-KLH conjugate to SKI/MEMORIAL to conduct the Study.
SKI/MEMORIAL may not use this GM2-KLH conjugate in any way other than as
specified in the Protocol.
2
<PAGE>
1.8 SKI/MEMORIAL shall use reasonable efforts to obtain an
institutional IND for purposes of conducting the Study. At ABI's request any
time in the three years after the Effective Date, SKI/MEMORIAL will assign
the IND to ABI at no additional charge and write a letter to the FDA to
inform them of the assignment of the IND to ABI. ABI shall indemnify
SKI/MEMORIAL for any use ABI makes of the IND after SKI/MEMORIAL has assigned
it to ABI, including attorney fees.
ARTICLE II - SKI/MEMORIAL STAFF AND FACILITIES
2.1 The Study shall be carried out at SKI/MEMORIAL under the
supervision of SKI/MEMORIAL's IRB and the Investigators indicated above.
2.2 SKI/MEMORIAL shall provide the physician, laboratory, statistical,
and clinical support staff levels of effort required to complete the Study.
ARTICLE III- REPORTS
3.1 SKI/MEMORIAL shall keep ABI advised of the status of the Study via
periodic reports. The frequency of such reports shall be mutually agreed to
by both parties. There shall also be a final report of the Study presented to
ABI.
3.2 All reports submitted to ABI shall become the property of ABI and
may be used by ABI without, however, making any reference to Memorial
Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and Allied
Diseases or Sloan-Kettering Institute for Cancer Research, unless such
reference appears in a communication with the FDA or as otherwise required by
law. If ABI desires to make reference to any of the foregoing in utilizing
the results of the Study, ABI must first obtain written consent from
SKI/MEMORIAL. SKI/MEMORIAL shall respond to any such ABI's request for
release of information within thirty (30) days after receiving ABI's request.
ARTICLE IV - PUBLICATION
4.1 Notwithstanding anything contained herein to the contrary including
without limitation Articles 5.1 and 9.6, SKI/MEMORIAL may freely publish the
results of its investigative findings hereunder. The authorship and contents
(including scientific conclusions and professional judgments) of any paper
submitted shall be determined by SKI/MEMORIAL. SKI/MEMORIAL shall provide ABI
with a copy of the papers prepared for publication prior to their submission
to a scientific journal or presentation at scientific meetings. ABI shall
have thirty (30) days to review the papers. ABI shall not make any editorial
changes in the papers, but may delete any of its Confidential Information (as
defined below) contained therein. ABI personnel shall be acknowledged with
customary scientific practice.
3
<PAGE>
ARTICLE V - CONFIDENTIAL INFORMATION
5.1 In order to effectively complete the Study, it may be necessary or
desirable for the parties to disclose proprietary, trade secret and/or other
confidential information (herein "Confidential Information") to one another.
Each party agrees that any such Confidential Information disclosed to it or
to its employees shall be used only in connection with the legitimate
purposes of this Agreement; shall be disclosed only to those who have a need
to know it, and shall be safeguarded with the same care normally afforded
such Confidential Information in the possession, custody or control of the
party receiving the Confidential Information provided, however, that the
disclosing party specifies in writing the nature and identity of the
Confidential Information and the manner and time of disclosure. The foregoing
shall not apply when, after and to the extent the Confidential Information
disclosed becomes generally available to the public through no fault of the
receiving party, was already known to the receiving party at the time of
disclosure as evidenced by written records in the possession of the receiving
party prior to such time, or is subsequently received by the receiving party
in good faith from a third party without breaching any confidential
obligation between the third party and the disclosing party.
ARTICLE VI - COMPENSATION
6.1 In consideration for SKI/MEMORIAL's participation and to cover the
costs associated with the Study, ABI shall pay SKI/MEMORIAL a total of
[***]
6.2 SKI/MEMORIAL shall discuss, if ABI so requests, budgetary matters
with ABI, but reserves the right to be the final control on budgetary
categories and expenditures. SKI/MEMORIAL shall not be obligated to provide
expenditure reports, or to submit to audits by ABI.
4
[***] Confidential Treatment Requested
<PAGE>
6.3 The checks shall be made payable to SLOAN-KETTERING INSTITUTE FOR
CANCER RESEARCH (Sloan-Kettering Institute Tax I.D. No. 13-1624182) and shall
be forwarded to:
Memorial Sloan-Kettering Cancer Center
Office of Industrial Affairs
1275 York Avenue
New York, New York 10021
ABI should note on its check stub or in its transmittal letter that the
payment relates to a Clinical Trial Agreement, SK#1267, under the direction
of Dr. Paul B. Chapman.
ARTICLE VII - INDEPENDENT CONTRACTOR
7.1 Both parties shall, at all times during the performance of this
Agreement, remain as independent contractors and the Agreement shall not make
the parties partners, joint venturers, or agents of one another. No party to
this Agreement shall have the power to bind or obligate the other party.
ARTICLE VIII - TERM AND TERMINATION
8.1 This Agreement shall commence on the Effective Date of this
Agreement and shall continue until completion as provided in the Protocol,
which is estimated at about twelve (12) months from the date hereof.
8.2 This Agreement can be terminated by either SKI/MEMORIAL or ABI
with or without cause upon thirty (30) days prior written notice without
penalty to either party.
8.3 In the event that a.) SKI/MEMORIAL terminates this Agreement prior
to completion of the Study, the amount due to SKI/MEMORIAL from ABI shall be
[***]
any time between the Effective Date and the date of termination of this
Agreement and then completes the Protocol; or b.) ABI terminates this
Agreement then in addition to [***]
8.4 If ABI terminates the Agreement prior to completion of the Study,
ABI shall, if permitted by law and requested by SKI/MEMORIAL, supply
SKI/MEMORIAL, free of charge, with sufficient GM2-KLH conjugate to allow
SKI/MEMORIAL to complete the treatment of those patients participating in the
Study on the date of SKI/MEMORIAL's receipt of ABI's termination notice.
5
*** Confidential Treatment Requested
<PAGE>
8.5 Sections 3.2, 4.1, 5.1, 8.3, 8.4, 8.5, 9.1, 9.6 and 9.7 shall all
survive the termination of this Agreement.
ARTICLE IX - GENERAL
9.1 ABI shall indemnify, defend and hold SKI/MEMORIAL, and its
affiliate corporation, Memorial Sloan-Kettering Cancer Center harmless from
and against all claims, causes of action, suits, damages and costs arising
out of, resulting from, or otherwise in respect of, the manufacture, sale
and/or use of GM2-KLH conjugate except where such claims, causes of action,
suits, damages and costs are the result of negligence on behalf of
SKI/MEMORIAL, its staff or agents. ABI shall have no obligation to indemnify,
defend or hold SKI/MEMORIAL harmless against liability, loss or damage
arising from a failure by SKI/MEMORIAL, its staff or agents to; (i) comply
with any applicable FDA or other governmental requirement or; (ii) adhere to
the terms of the Protocol.
SKI/MEMORIAL shall indemnify, defend and hold ABI harmless from and
against all claims, causes of action, suits, damages and costs arising out
of, resulting from, or otherwise in respect of, the manufacture, sale and/or
use of GM2-KLH conjugate except where such claims, causes of action, suits,
damages and costs are the result of negligence on behalf of ABI, its staff or
agents. SKI/MEMORIAL shall have no obligation to indemnify, defend or hold
ABI harmless against liability, loss or damage arising from a failure by ABI,
its staff or agents to; (i) comply with any applicable FDA or other
governmental requirement or; (ii) adhere to the terms of the Protocol.
9.2 No right or license is granted under this Agreement by either
party to the other either expressly or by implication, except those
specifically set forth herein.
9.3 Nothing contained within this Agreement shall impose an obligation
of exclusivity on one party by the other. Both parties reserve the right to
enter into and participate in other activities (either alone or with a third
party) including, but not limited to, clinical trials and sponsored research
projects.
9.4 All matters affecting the interpretation, validity and performance
of this Agreement shall be governed by the laws of the State of New York
applicable to agreements made and to be performed wholly within the State of
New York. This Agreement, including the Protocol, sets forth the entire
understanding between the parties
6
<PAGE>
herein, and cannot be changed or amended except by written agreement executed
by the parties. In the event of any inconsistency in this Agreement, the
inconsistency shall be resolved by giving precedence first, to the Articles
of this Agreement, and then, to the Protocol. This Agreement may not be
assigned by either party without the prior written consent of the other party.
9.5 All notices to be given by either party to the other shall be made
in writing by hand delivery or by registered or certified mail, return
receipt requested and addressed to the parties at the following addresses
respectively:
Sloan-Kettering Institute for Cancer Research
1275 York Avenue
New York, New York 10021
(Attention: Director, Office of Industrial Affairs)
(Copy: James S. Quirk, Senior Vice President)
Active Biotherapies, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
(Attention: Paul J. Madddon, M.D., Ph.D.
President and CEO)
Any notice shall be effective as of its date of receipt.
9.6 Except as set forth in articles 5.1 and 4.1, as required by law
and/or as may be required in order to maintain a party's status as an exempt
organization under Section 501(c) (3) of the Internal Revenue Code and
regulations thereunder, neither SKI/MEMORIAL nor ABI shall release any
information, publicity, news releases or other public announcement, written
or oral, with regard to the Agreement or any amendment thereto or to
performance hereunder, to newspapers or any other mass communication media
without the prior written approval of the other party. SKI/MEMORIAL shall
respond to any such ABI's request for release of information within thirty
(30) days after receiving ABI's request. ABI shall not use the name of
Memorial Sloan-Kettering Cancer Center, Memorial Hospital for Cancer and
Allied Diseases or Sloan-Kettering Institute for Cancer Research, or a
variant of any of the foregoing in any advertising, packaging or other
promotional material in connection with the GM2-KLH conjugate except as may
be required by law.
7
<PAGE>
IN WITNESS THEREOF, SKI/MEMORIAL and ABI have caused this Agreement to
be executed in duplicate by their respective duly authorized officers.
ACTIVE BIOTHERAPIES, INC. SLOAN-KETTERING INSTITUTE
FOR CANCER RESEARCH, AND
By: /s/ Paul J. Maddon MEMORIAL HOSPITAL FOR AND
--------------------------- ALLIED DISEASES
Paul J. Maddon, M.D., Ph.D.
President and CEO
Date: Dec. 23, 1994 By: /s/ James S. Quirk
---------- -------------------------------
James S. Quirk
Senior Vice President
Research Resources Management
Date: Dec. 12, 1994
-------
By: /s/ Paul B. Chapman
-------------------------------
Paul B. Chapman, M.D.
Principal Investigator
Date: Dec 4, 1994
-------
8
<PAGE>
Exhibit 10.20
SUPPLY AGREEMENT
This supply agreement is entered into as of July 1, 1996 (the "Effective
Date") between PerImmune, Inc. ("PerImmune") and Progenics Pharmaceuticals,
Inc. (each singularly a "Party" and collectively the "Parties") with
reference to the following:
RECITALS
WHEREAS, PerImmune, Inc. manufactures purified keyhole limpet hemocyanin
("KLH"); and
WHEREAS, Progenics Pharmaceuticals, Inc. is performing research and
development in the field of vaccines for human cancers and is interested in
purchasing KLH from PerImmune, Inc. for use as a carrier protein for such
vaccines;
THEREFORE, the parties agree as follows:
1. DEFINITIONS. The following terms shall have the following meanings for
purposes of this Agreement:
1.1 "AFFILIATE" means any corporation, firm, partnership or other
entity, whether de jure or de facto, which directly or indirectly owns, is
owned by, or is under common ownership with a party to this Agreement to the
extent of at least fifty percent (50%) of the equity (or such lesser
percentage which is the maximum allowed to be owned by a foreign corporation
in a particular jurisdiction) having the power to vote on or direct the
affairs of the entity and any person, firm, partnership, corporation or other
entity actually controlled by, controlling, or under common control with a
party to this Agreement. For example, Akzo, N.Y. is an Affiliate of PerImmune
pursuant to this definition.
1.2 "AGREEMENT" means this Supply Agreement, including any exhibits,
schedules or other attachments thereto, as any of the foregoing may be
validly amended and agreed to in writing by the Parties from time to time.
1.3 "COMMERCIAL INTRODUCTION" means the date of first commercial sale
(other than for purposes of obtaining regulatory approval) of a Ganglioside
Vaccine by Progenies Pharmaceuticals, Inc.
1.4 "EFFECTIVE DATE" is defined in the introductory paragraph.
1.5 "FULLY BURDENED MANUFACTURING COST" means the actual cost of
Manufacture by PerImmune of KLH under a Manufacturing Process in compliance
with
<PAGE> Page 2
cGMPs, which actual cost shall be comprised of the cost of goods produced as
determined in accordance with United States generally accepted accounting
principles, [***]
1.6 "cGLPs" means the current Good Laboratory Practices for Finished
Pharmaceuticals pursuant to 21 C.F.R. 58 et sea., as amended from time to
time.
1.7 "cGMPs" means the current Good Manufacturing Practices for Finished
Pharmaceuticals pursuant to 21 C.F.R. 210 et seci., as amended from time to
time.
1.8 "KLH" means keyhole limpet hemocyanin.
1.9 "KLH REQUIREMENTS" means the amount of KLH in bulk which Progenics
Pharmaceuticals, Inc. may require for all research and development,
pre-clinical and human clinical testing of Ganglioside Vaccines and, after
Commercial Introduction, production of Ganglioside Vaccines for commercial
sales.
1.10 "KNOW-HOW" means materials, data, results, formulae, designs,
specifications, methods, processes, improvements, techniques, ideas,
discoveries, technical information, process information, clinical information
and any other information, whether or not any of the foregoing is patentable,
which is confidential (in accordance with Section 5 hereof and proprietary to
PerImmune now or hereafter during the Term of this Agreement, to the extent
that any of the foregoing relates to the development, manufacture, use or
sale of KLH in connection with the development, manufacture, use or sale of
any Gangiloside Vaccine, provided however, that the term "Know-how" shall not
include any of the foregoing that is subject to proprietary rights of third
parties.
1.11 "GANGLIOSIDE VACCINE" means any vaccine or vaccines comprising
purified gangliosides (whether alone or in combination) conjugated to KLH for
the prevention or treatment of human cancers. A ganglioside is a neuraminic
acid containing glycolipids.
1.12 "MANUFACTURE" OR "MANUFACTURING PROCESS" means the aseptic-storage,
handling, production, processing and packaging of KLH in accordance with this
Agreement.
1.13 ."MANUFACTURING YEAR" means each calendar year commencing on or after
January 1, 1995.
1.14 "PARTY" and "PARTIES" are defined in the introductory paragraph.
1.15 "PERIMMUNE" means PERIMMUNE, INC., (formerly Organon Teknika
Corporation Biotechnology Research Institute) , a Delaware corporation, its
Affiliates and its successors and permitted assigns.
[***] Confidential Treatment Requested
<PAGE>
Page 3
1.16 "SPECIFICATIONS" is defined in Exhibit A
1.17 "TERM" is defined in Section 4.1.
1.18 "PROGENICS" means Progenics Pharmaceuticals, Inc., a Delaware
corporation, its Affiliates and its permitted successors and assigns.
2. MANUFACTURE AND SUPPLY.
2.1 GENERAL. Progenics agrees that PerImmune shall have the exclusive
right and obligation during the Term to Manufacture and supply to Progenics
one hundred percent (100%) of its KLH Requirements for purposes of research
and development, pre-clinical studies and human clinical trials and
commercial sales of all Ganglioside Vaccines throughout the world. PerImmune
agrees that, for the purposes of Ganglioside Vaccines, it will provide KLH
exclusively to Progenics and PerImmune will not knowingly supply KLH to third
party manufacturers of Ganglioside Vaccines. PerImmune hereby agrees, at its
sole expense, to commit all reasonably necessary facilities, appropriately
trained personnel, machinery, equipment, utilities and other PerImmune resources
required to satisfy its obligations under this Agreement.
2.2 PERIMMUNE TRANSFER PRICE OF KLH.
With respect to each and every Ganglioside Vaccine, PerImmune shall
Manufacture and supply one hundred percent (100%) of KLH Requirements of such
Ganglioside Vaccine, including for purposes of all research and development,
preclinical studies and human clinical trials, and the Commercial sales of
such Ganglioside Vaccine. [***]
In addition, in order to verify the production cost of KLH, Progenics will
have the right to pay for an independent certified public accountant, ("CPA")
to inspect the records of PerImmune once per year during regular business
hours, provided that such accountant has entered into a confidentiality
agreement with PerImmune which is satisfactory to PerImmune. The CPA shall
then compile a report which states only PerImmune's Fully Burdened
manufacturing Cost for KLH which may be used by the Parties for negotiating
the transfer price.
2.3 PERlMMUNE'S REPRESENTATIONS, WARRANTIES AND COVENANTS. PerImmune
hereby represents and warrants to Progenics as follows:
(a) PRE-CLINICAL STUDY AND HUMAN CLINICAL TRIAL USE, PerImmune shall
Manufacture all KLH Requirements for use in any vaccine used in connection
with any pre-clinical study or human clinical trial of any Ganglioside
Vaccine (i) strictly in compliance with (A) this Agreement, (B) all
Specifications, and (C) all applicable laws
[***] Confidential Treatment Requested
<PAGE>
Page 4
and regulations, including but not limited to cGMPs to the extent applicable,
and (ii) in a PerImmune facility holding all applicable licenses in the
jurisdiction of Manufacture.
(b) COMMERCIAL USE. PerImmune shall Manufacture all KLH Requirements for
use in the commercialization of any Ganglioside Vaccine (i) strictly in
compliance with (A) this Agreement, (B) all Specifications, and (C) all
applicable laws and regulations, including but not limited to cGMPs to the
extent applicable, and (ii) in a PerImmune facility holding all applicable
licenses in the jurisdiction of Manufacture.
(c) CERTIFICATE OF ANALYSIS: NON-COMPLYING KLH. Before, during and after
Manufacture of KLH Requirements, PerImmune shall obtain samples, monitor the
Manufacturing Process and the environment of such Manufacture, and keep such
technical books and records of all of the foregoing as are required under the
Specifications and Procedures and all applicable laws and regulations,
including but not limited to cGLPs or cGMPs (as appropriate and applicable).
PerImmune shall test each lot of KLH requirements Manufactured for Progenics
or as required under the Specifications. Together with each such lot of KLH
Requirements, PerImmune shall provide a written certificate of analysis which
shall set forth the results of such testing by PerImmune and PerImmune's
quality control approval of such lot of KLH Requirements. PerImmune's
obligations under this section 2.3(c) shall be performed at PerImmune's sole
expense. Progenics shall be entitled to test any such KLH Requirements in
accordance with the Specifications, at Progenics' sole expense. Without
limiting any of Progenics' other rights or remedies under this Agreement with
respect to any KLH Requirements supplied hereunder that do not comply with
applicable representations and warranties under this Section 2.3, and
provided PerImmune reasonably confirms Progenics' test results, the Parties
agree that; (i) Progenics shall not be obligated to pay PerImmune the
transfer price applicable to such non-complying KLH Requirements; (ii) if
Progenics has already paid for such non-complying KLH Requirements, Progenics
shall be entitled to a credit against future purchases for the amount paid to
PerImmune therefor; (iii) PerImmune shall, on a priority basis, Manufacture
and supply to Progenics, as applicable, replacement KLH Requirements in full
compliance with this Section 2.3; and (iv) PerImmune shall bear the full cost
of returning or destroying the non-complying KLH Requirements.
2.4 Procedures for Estimating, Ordering and Supplying - KLH REQUIREMENTS.
Subject to the other terms of this Agreement:
(a) ANNUAL DEMAND FORECAST FOR EACH MANUFACTURING YEAR. During the Term,
commencing on July 1 , 1996 and on an on-going quarterly basis as described
below, Progenics will provide PerImmune with a written rolling annual demand
forecast of KLH Requirements for each manufacturing Year which shall be
binding as to the first quarter and non-binding as to the remaining three (3)
quarters. Thereafter, Progenics shall provide an updated annual demand
forecast on a quarterly
<PAGE>
Page 5
basis no later than ninety (90) days in advance of the commencement of the
first (and binding) quarter covered by such annual demand forecast. The
Parties also agree that the variance, if any, between the binding forecast of
a given quarter and the last nonbinding forecast for such quarter shall be
between [***] and [***]
meaning that Progenics' binding forecast for such quarter must be at least
[***] but not more than [***]
of such last non-binding forecasted amount for such quarter.
(b) PURCHASE ORDERS. Progenics shall place a firm purchase order or
purchase orders with PerImmune setting forth (i) the quantities of KLH
Requirements to be Manufactured and supplied hereunder, (ii) the schedule for
receipt from PerImmune of such batch(es) of KLH Requirements, and (iii)
instructions for shipping and packaging. Each such firm purchase order shall
be submitted no later than thirty (30) days in advance of the first scheduled
date of receipt thereof. Subject to the other terms of this Agreement,
Progenics shall be obligated to place firm purchase orders with PerImmune
for, and PerImmune hereby commits to Manufacture and supply hereunder
pursuant to such firm purchase orders, [***] of the
amount of KLH Requirements in the then-binding quarter of each annual demand
forecast under Section 2.4(b); provided, however, that: (A) the Parties may
mutually agree in writing to amend any such firm purchase order; (B)
PerImmune in its discretion may agree to Manufacture and supply hereunder
additional amounts of KLH Requirements in excess of the then-binding amount,
provided that Progenics places firm purchase order(s) for such excess KLH
Requirements on a timely basis; and (C) PerImmune agrees to provide Progenics
with as much advance written notice as possible (and in any case at least
thirty (30) days' written advance notice) if PerImmune determines that any
scheduled delivery of KLH Requirements pursuant to any purchase order will be
delayed by more than fifteen (15) days for any reason of which PerImmune
becomes aware.
2.5 PRIORITY.
a) PRIORITY AMONG CUSTOMERS. PerImmune hereby agrees and acknowledges
that, in the event that PerImmune is unable to satisfy in full its
obligations under this Agreement to Manufacture and supply
[***] of KLH Requirements as well as PerImmune's obligations to
third parties with respect to Manufacture and supply of KLH, PerImmune shall
use reasonable efforts to satisfy its obligations under this Agreement and,
in the event of any shortage of KLH available to meet all such obligations,
PerImmune shall allocate proportionately all available KLH among Progenics
and such third parties with highest priority for the Manufacture and supply
of KLH for purposes of outstanding firm purchase orders for comparable
delivery time frames. In such event PerImmune, shall be permitted to invoice,
and Progenics agrees to pay, the additional expenses of PerImmune for such
efforts.
[***] Confidential Treatment Requested
<PAGE> Page 6
(b) INABILITY TO SUPPLY. In the event that PerImmune is unable to supply
[***] of Progenics' purchase orders for two consecutive quarters, then
PerImmune agrees to provide Progenics the right and license to use the
relevant Know-how to manufacture or have manufactured KLH for use in
producing Ganglioside Vaccine, and to fully cooperate with regulatory
authorities to qualify Progenics and/or its designee as a manufacturer of
KLH. In such event, at Progenics' request, PerImmune shall promptly disclose
to Progenics all Know-how and information reasonably necessary to manufacture
KLH and the parties shall mutually agree upon a reasonable schedule for
gradually reducing the amount of KLH purchased by Progenics from PerImmune,
until such time PerImmune is able to reasonably demonstrate the ability to
supply Progenics with its requirements.
(c) ASSURANCE OF SUPPLY. Progenics and PerImmune will cooperate to
anticipate Progenics' long-term requirements for KLH Requirements supply, and
PerImmune will take reasonable measures to assure that Progenics' and its
Partners' KLH Requirements can be met, which measures may include the
maintenance of adequate safety stocks of KLH.
2.6. REGULATORY APPROVAL OF MANUFACTURING. PerImmune shall be solely
responsible, at its sole cost and expense, for obtaining all necessary
regulatory approvals particular to KLH for Manufacture and supply of KLH
Requirements. Progenics shall advise PerImmune of any new Specifications
required by the United States Food and Drug Administration or the Federal
Food, Drug and Cosmetic Act (or the equivalent regulatory authority or law In
other countries) with respect to any Ganglioside Vaccine. PerImmune shall not
modify in any manner any Specifications without Progenics prior written
consent (which consent shall not be unreasonably withheld).
2.7 REGULATORY FILINGS. Without limiting the generality of the
foregoing, for purposes of supporting all preclinical studies and human
clinical trials and all regulatory filings, applications and approvals on the
part of Progenics with respect to any Ganglioside Vaccine, PerImmune hereby
agrees that on an on-going basis during the Term: (1) PerImmune shall permit
Progenics to reference PerImmune's drug master file and/or Investigational
New Drug Applications (IND's) for KLH with the United States Food and Drug
Administration; (ii) to the extent not subject to the proprietary rights of
third parties, PerImmune shall provide Progenics with all pre-clinical and
clinical data, results and other relevant information with respect to KLH
(including but not limited to information regarding the toxicity, safety and
stability of KLH) that is (A) submitted by PerImmune in connection with any
Investigational New Drug application or other regulatory filing with respect
to KLH from time to time during the Term or (B) otherwise in PerImmune's
possession from time to time during the Term; and (iii) a PerImmune
representative, at Progenics' request, shall attend periodic meetings to
discuss the progress of clinical trials of any Ganglioside Vaccines.
Progenics will reimburse
[***] Confidential Treatment Requested
<PAGE>
Page 7
PerImmune for the foregoing assistance only (i) for its reasonable out-of
pocket expenses, including but not limited to travel, and (ii) PerImmune's
fully burdened costs of performing technical studies or engaging outside
services subject to the prior approval of Progenics.
a) ADVERSE EVENTS REPORTING. On an on-going basis during the Term and
for at least ten (10) years after the expiration or termination of this
Agreement, each Party agrees to provide the other Party with any written
information in its possession which indicates adverse effects in humans
associated with KLH or any products using KLH.
2.8 PERIMMUNE RECORDKEEPING AND INSPECTION.
(a) TECHNICAL RECORDS. With respect to any Manufacture and supply of KLH
Requirements, PerImmune shall, at its expense, keep properly completed
technical books and records, test data and reports as required under the
Specifications and all applicable laws and regulations, including but not
limited to cGLPs or cGMPs (as appropriate), and in any case shall maintain
such technical Information for at least two (2) years from the expiration
date of the relevant Ganglioside Vaccine or longer if required under
applicable laws and regulations (including but not limited to cGLPs and
cGMPs, as applicable). During regular business hours and upon reasonable
advance written request, PerImmune shall make any such technical information
available to Progenics for inspection.
(b) FINANCIAL RECORDS. During the Term, PerImmune shall keep for at
least three (3) years records of its Fully Burdened Manufacturing Costs, and
the calculations thereof in sufficient detail to permit Progenics designee,
reasonably acceptable to PerImmune, to confirm the accuracy thereof. At the
request of Progenics, and not more frequently than once per year, upon at
least five (5) business days' prior written notice, and at the expense of
Progenics (except as otherwise provided below), PerImmune shall permit a
nationally recognized, independent, certified public accountant selected by
Progenics and acceptable to PerImmune to inspect (during regular business
hours) any such PerImmune records for the then-preceding three (3) years
solely to the extent necessary to verify such costs, margins and
calculations, provided that such accountant in advance has entered into a
confidentiality agreement with PerImmune and Progenics substantially similar
to the confidentiality provisions of this Agreement, limiting the use and
disclosure of such information to authorized representatives of the Parties.
Results of any such inspection shall be made available to both Parties. If
such inspection reveals a deficiency in the calculation of PerImmune's Fully
Burdened Manufacturing Cost to PerImmune resulting in an overpayment to
PerImmune of the transfer price by [***] , PerImmune shall
pay all costs and expenses of such inspection.
[***] Confidential Treatment Requested
<PAGE>
Page 8
(c) QUALITY AUDIT. Upon submission of a proposal by Progenics which is
approved by PerImmune, PerImmune shall permit Progenics to audit, in
cooperation with PerImmune's personnel, production, packaging, and quality
control facilities of PerImmune and any of its significant suppliers as they
relate to production of KLH to allow Progenics to verify PerImmune's
compliance with its responsibilities under this Agreement.
2.9 LIABILITY.
(a) INDEMNIFICATION BY PROGENICS. Except as otherwise provided in
Sections 2.9(b) or (c), Progenics will defend, indemnify and hold harmless
PerImmune against any and all claims, actions, liabilities, damages, losses,
costs or expenses, including reasonable attorney's fees, based upon or
arising out of the sales or use of any Ganglioside Vaccine by Progenics,
provided that PerImmune gives Progenics prompt notice thereof in writing,
permits Progenics to control the investigation, preparation and defense
thereof (including any compromise or settlement thereof and any appeal) and
provides reasonable assistance to Progenics, at Progenics expense, in that
regard.
(b) LIABILITY. Each Party assumes full responsibility and liability for
any injury, damage or expense which it or its employees, agents and invitees
incur and which arise from its manufacture, handling and use of KLH or
Ganglioside Vaccines, except to the extent such injury, damage or expense
arises from the negligence or willful misconduct of the other Party.
(c) INDEMNIFICATION BY PERIMMUNE. PerImmune will defend, indemnify and
hold harmless Progenics against any and all claims, actions, liabilities,
damages, losses, costs or expense (including reasonable attorneys' fees)
including without limitation expenses of total or partial product recalls in
connection with the manufacture, use or sale of Ganglioside Vaccines (i)
based upon the gross negligence or willful misconduct of PerImmune or its
employees arising out of the Manufacture or shipment of KLH Requirements by
PerImmune or based upon a manufacturing defect in KLH Requirements
manufactured by PerImmune; or (ii) the failure of PerImmune to comply with
governmental regulations with respect to KLH, provided that Progenics or its
Partners give PerImmune prompt notice thereof in writing, permits PerImmune
to control the investigation, preparation and defense thereof (including any
compromise or settlement thereof and any appeal) and provides reasonable
assistance to PerImmune, at PerImmune's expense, in that regard.
3. CONFIDENTIALITY.
3.1. Each party agrees to take such steps and, when necessary to protect
the rights of the other, shall cause its employees and agents and its
Affiliates employees and agents, to take such steps as are reasonably
required to protect and keep
<PAGE>
Page 9
confidential, and shall not use, publicize or otherwise disclose to third
parties other than Affiliates, Confidential Information (as defined below) of
the other party, which was acquired from the other party pursuant to this
Agreement, including, without limitation, following procedures designed to
limit access of such information to those persons having a need to know it.
The parties agree not to disclose or use such Confidential Information except
as they may be entitled to do so or if necessary pursuant to or in the
performance of this Agreement.
3.2 The obligation of confidentiality and restriction on use imposed by
the foregoing Subsection 3.1 shall not apply to any particular item of
Confidential Information that:
3. 2.1 is known or generally available, or subsequently becomes known or
generally available, to the public, or is otherwise at the time of disclosure
or subsequently becomes part of the public domain, whether by printed
publication or otherwise through no fault of the receiving parties;
3.2.2 the receiving party can demonstrate by competent evidence, based
in substance upon writings and/or physical evidence, (i) was known to the
receiving party at the time of receipt or (ii) is furnished to the receiving
party without obligation of confidentiality or non-use by a third party,
either before or after the time of its disclosure by the disclosing party,
which third party is not restricted by a confidential undertaking to the
disclosing party at the time of the disclosure;
3.2.3 the receiving party can demonstrate by competent evidence, based
in substance upon writings and/or physical evidence, has been developed
independently for the receiving party by persons not having access to the
Confidential information; or
3.2.4 is the Confidential Information of the disclosing party and that
the disclosing party discloses to a non-Affiliate party without restriction.
3.3 The obligations of confidentiality and restriction on use under this
Section 3 shall continue to be binding upon the parties for a period of five
years following termination of this Agreement.
3.4 Either party may also disclose Confidential Information disclosed to
it by the other party to the extent, and only to the extent, such disclosure
is necessary for such party to comply with applicable governmental laws or
regulations. The party that desires to so disclose Information shall give the
other party reasonable advance notice of any such proposed disclosure
pursuant to such compliance with law or regulation, shall use its best
efforts to secure confidential treatment of the Information thus disclosed,
and shall advise the other party in writing of the manner in which that was
done.
<PAGE>
Page Page 10
3.5 For purposes of this Agreement, Confidential Information shall
mean: (a) data, inventions, Information, processes, know-how, patent
applications, trade secrets and similar intellectual property rights of a
party, including, without limitation, the original and copies of all
documents, inventions, laboratory notebooks, drawings, specifications,
devices, equipment, prototype models and tangible manifestations embodying
any technology disclosed hereunder, (b) a party's customer lists and
marketing, sales, costs, royalty and similar information related to the
manufacture or sale of KLH or other part of the Parties' business, and (c)
any other information disclosed in writing and marked as "Confidential
Information" or, if disclosed orally, reduced to writing and marked as
"Confidential Information" and submitted within thirty (30) days of the
original oral disclosure.
3.6 PERMITTED DISCLOSURES. Each Party may disclose the other Party's
information to the extent such disclosure is reasonably necessary in
prosecuting or defending litigation, filing, prosecuting or maintaining
patent applications or patents, complying with applicable laws or
regulations, or, in the case of Progenics, conducting preclinical or clinical
trials or preparing or filing regulatory filings with respect to Ganglioside
Vaccines; provided, however, that if a Party is required to make any
disclosure of the other Party's information furnished pursuant to this
Agreement, it will give reasonable advance notice of such disclosure
requirements to the other Party and, except to the extent inappropriate in
the case of patent applications, will use its best efforts to secure
confidential treatment of such information required to be disclosed.
4. TERM: TERMINATION.
4.1 TERM. The term of this Agreement shall be for three years from the
Effective Date and will renew automatically for successive 12 month periods
unless sooner terminated as provided in this Section 4.
4.2 MATERIAL BREACH. Subject to Section 8.6, failure by either Party to
comply with any of the material obligations contained in this Agreement shall
entitle the other Party to give to the Party in default notice specifying the
nature of the default and requiring it to make good such default. If such
default is not cured within sixty (60) days after the receipt of such notice,
the notifying Party shall be entitled, without prejudice to any of its other
rights conferred on it by this Agreement and in addition to any other
remedies available to it by law or in equity, to terminate this Agreement
effective upon written notice to the other Party. The right of a Party to
terminate this Agreement, as herein above provided, shall not be affected in
any way by its waiver or failure to take action with respect to any previous
default.
4.3 INSOLVENCY OR BANKRuPTCY. Either Party may, in addition to any other
remedies available to it by law or in equity, terminate this Agreement, in
whole or in part as the terminating Party may determine, effective upon
written notice to the other Party, in the event the other party shall have
become insolvent or bankrupt, or shall have
<PAGE>
Page 11
made an assignment for the benefit of its creditors, or there shall have been
appointed a trustee or receiver of the other Party for all or a substantial
part of its property, or any case or proceeding shall have been commenced
seeking reorganization, liquidation, dissolution, winding-up, arrangement,
composition or readjustment of its debts or any other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of any
jurisdiction now or hereafter in effect, or there shall have been issued a
warrant of attachment, execution, disdain or similar process against, any
substantial part of the property of the other Party, and any such event shall
have continued for sixty (60) days undismissed, unbounded and undischarged.
4.4 ACCRUED RIGHTS, SURVIVING OBLIGATIONS: PARTNERS. Expiration or any
termination of this Agreement for any reason shall be without prejudice to
any rights which shall have accrued to the benefit of either Party prior to
such expiration or termination. Such expiration or termination shall not
relieve either Party from obligations which are expressly indicated to
survive expiration or termination of this Agreement, which obligations
include, without limitation, those under Sections 2.8, 2.9, 3, 5, 6 and 7.
5. PERIMMUNE PATENT RIGHTS.
PerImmune shall not assert against Progenics or its customers any
patents now or hereinafter owned or controlled by PerImmune which concern KLH
or any Ganglioside Vaccine of Progenics which incorporates KLH. This Section
shall continue to apply to any Affiliate of PerImmune which ceases to be an
Affiliate of PerImmune as defined by this Agreement.
6. PERiMMUNE REPRESENTATIONS AND WARRANTIES.
PerImmune represents and warrants that:
(a) the execution and delivery of this Agreement and the performance of
the transactions contemplated hereby have been duly authorized by PerImmune;
(b) the performance by PerImmune of any of the terms and conditions of
this Agreement on its part to be performed does not and will not constitute a
breach or violation of any other agreement or understanding, written or oral,
to which it is a party;
(c) To the best of PerImmune's knowledge, there are no adverse
proceedings, claims or actions pending, or threatened, relating to KLH and at
the time of disclosure and delivery thereof to Progenics and PerImmune shall
have the full right
<PAGE>
Page 12
and legal capacity to disclose and deliver KLH without violating the rights
of third parties.
7. ARBITRATION.
Any dispute, controversy or claim between the Parties, arising out of or
relating to this Agreement or the Parties' respective rights and obligations
hereunder either during or after the Term (including the question as to
whether any such matter is arbitrable) shall be subject to binding
arbitration in accordance with then-existing commercial arbitration rules of
the American Arbitration Association. The Parties agree that, in the course
of any such arbitration, service of any notice at their respective addresses
in accordance with Section 8.11 of this Agreement shall be valid and
sufficient, and any arbitration hereunder shall be in the jurisdiction of the
defendant Party, which in the case of Progenics shall be New York and in the
case of PerImmune shall be Maryland. In any such arbitration, an award shall
be rendered by a majority of the members of a board of arbitration consisting
of three (3) members, one (1) of whom shall be chosen by each of Progenics
and PerImmune and the third of whom shall be appointed by mutual agreement of
such two (2) arbitrators. In the event of failure of such two (2) arbitrators
to agree within sixty (60) days after the commencement of arbitration (as
defined below) upon appointment of the third arbitrator, or, in the event
that either Party shall fail to appoint an arbitrator within thirty (30) days
after the commencement of the arbitration proceedings, the third arbitrator
or (upon request of the other Party) the second arbitrator and the third
arbitrator, as the case may be, shall be appointed by the American
Arbitration Association in accordance with its then existing commercial
arbitration rules. For purposes of this Section, the "commencement of the
arbitration proceeding" shall mean the date upon which the defendant Party
receives from the American Arbitration Association a copy of the request for
arbitration filed by the party desiring to have recourse to arbitration. The
decision of the arbitrators shall be in writing and shall set forth the basis
therefor. The Parties shall abide by all awards rendered in arbitration
proceedings, and such awards may be enforced and executed upon in any court
having jurisdiction over the Party against whom enforcement of such award is
to be sought. The Parties shall divide equally the administrative charges,
arbitrators' fees, and related expenses of arbitration, but each Party shall
pay its own legal fees incurred in connection with any such arbitration;
provided, however, if the arbitrators determine that one Party prevailed
clearly and substantially over the other Party, then the non-prevailing Party
shall also pay the reasonable attorneys' fees and expert witness costs and
other arbitration costs of the prevailing Party.
<PAGE>
Page 13
8. MISCELLANEOUS PROVISIONS.
8.1 NO PARTNERSHIP. Nothing in this Agreement is intended or shall be
deemed to constitute a partnership, distributorship, agency employer-employee
or joint venture relationship between the Parties. No Party shall incur any
debts or make any commitments for the other, except to the extent, if at all,
specifically provided herein.
8.2 ASSIGNMENTS. Neither Party shall assign any of its rights or
obligations hereunder or this Agreement, except that either Party may do so:
(a) as incident to the merger, consolidation, reorganization or acquisition
of stock or assets affecting substantially all of the assets or voting
control of such Party; (b) to any wholly owned subsidiary if such Party
remains liable and responsible for the performance and observance of all of
the subsidiary's duties and obligations hereunder; (c) with the prior written
consent of the other Party; or (d) as incident to an agreement between
Progenics and a major corporate partner. This Agreement shall be binding upon
the successors and permitted assigns of the Parties and the name of a Party
appearing herein shall be deemed to include the names of such Party's
successors and permitted assigns to the extent necessary to carry out the
intent of this Agreement. Any assignment not in accordance with this Section
8.2 shall be void.
8.3 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of
this Agreement.
8.4 NO NAME OR TRADEMARK RIGHTS. Except as otherwise provided herein,
no right, express or implied, is granted by this Agreement to use in any
manner the names "PerImmune, Inc." or "Progenics Pharmaceuticals, Inc." or
any contraction thereof or any other trade name or trademark of PerImmune or
Progenics in connection with the performance of this Agreement.
8.5 PUBLIC ANNOUNCEMENT. Except as may otherwise be required by
applicable law or regulation, neither Party shall make any public
announcement concerning this Agreement or the subject matter hereof without
the prior written consent of the other Party (not to be unreasonably
withheld).
8.6 FORCE MAJEURE. If any default or delay occurs which prevents or
materially impairs a Party's performance and is due to a cause beyond the
Party's reasonable control, including but not limited to any act of any god
or demon, flood, fire, explosion, earthquake, casualty, accident, war,
revolution, civil commotion, blockade or embargo, injunction, law,
proclamation, order, regulation or governmental demand, the affected Party
promptly shall notify the other Party in writing of such cause and shall
exercise diligent efforts to resume performance under this Agreement as soon
as possible. Neither Party shall be liable to the other Party for any loss or
damage due to such cause. Neither Party may terminate this Agreement because
of such default or delay.
<PAGE>
Page 14
8.7 ENTIRE AGREEMENT OF THE PARTIES: AMENDMENTS. This Agreement,
including the exhibits attached hereto which are incorporated herein,
constitutes and contains the entire understanding and agreement of the
Parties and cancels and supersedes any and all prior negotiations,
correspondence, understandings and agreements, whether verbal or written,
between the Parties respecting the subject matter hereof. No waiver,
modification or amendment of any provision of this Agreement shall be valid
or effective unless made in writing and signed by a duly authorized officer
of each of the Parties.
8.8 SEVERABILITY. In the event that any of the provisions of this
Agreement shall for any reason be held by any court or authority of competent
jurisdiction to be invalid, illegal or unenforceable, such provision or
provisions shall be validly reformed to as nearly as possible approximate the
intent of the Parties and, if unreformable, shall be divisible and deleted in
such jurisdiction; elsewhere, this Agreement shall not be affected so long as
the Parties are still able to realize the principal benefits bargained for in
this Agreement.
8.9 CAPTIONS. The captions to this Agreement are for convenience only,
and are to be of no force or effect in construing or interpreting any of the
provisions of this Agreement.
8.10 APPLICABLE LAW. This Agreement shall be governed by and
interpreted in accordance with the laws of Maryland.
8.11 NOTICE. All notices and other communications shall be deemed to
have been duly given when delivered in person or by registered or certified
mail (postage prepaid, returned receipt requested) to the respective parties
as follows:
If To Progenics:
Paul J. Maddon, M.D., Ph.D.
Chairman and CEO
- ---------------------------
777 Old Saw Mill River Road
- ---------------------------
Tarrytown, NY 10591
- ----------------------------
<PAGE>
Page 15
If To PerImmune:
Michael G. Hanna, Jr.
- ------------------------
President & CEO
1330 Piccard Drive
- ------------------------
Rockville, MD 20850
- ------------------------
8.12 SURVIVAL. The representations, warranties, covenants and
agreements made herein shall survive any investigation made by a Party and
shall be able to be relied fully on by the Parties.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be
signed by their respective corporate officers, duly authorized as of the day
and year first above written. PerImmune, Inc., represents and warrants that
it has the right and authority to provide to Progenics the material and
rights set forth in this agreement pursuant to the transfer of relevant right
and authority from Akzo Nobel to PerImmune.
PERIMMUNE, INC. PROGENICS PHARMACEUTICALS, INC.
By: /s/ Michael G. Hanna, Jr. By: Paul J. Maddon
- ---------------------------- ----------------------
Name: Michael G. Hanna, Jr. Name: Paul J. Maddon
- --------------------------- -----------------------
Title: President & CEO Title: Chairman and CEO
- --------------------------- -----------------------
<PAGE>
As set forth in this Exhibit A, the following are the specifications for the
Manufacture of KLH, as may from time to time be required by the Food and Drug
Administration (the "Specifications").
<PAGE>
EXHIBIT A
ORGANON TEKNIKA
[GRAPHIC] AKZO
CERTIFICATE OF ANALYSIS
KEYHOLE LIMPET HEMOCYANIN
[***]
[***] Confidential Treatment Requested
