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 000 Xxxxxx Xx., Xxxxxx, XX 00000
("DUPONT"), and PROGENICS PHARMACEUTICALS, INC., a Delaware
corporation with its principal place of business at Xxx Xxx Xxxx
Xxxxx Xxxx, Xxxxxxxxx, Xxx Xxxx 00000 ("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.
X. XXXXXX 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.
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
X. XXXXXX 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,
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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 [***]
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[***] Confidential Treatment Requested
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.
X. XXXXXX will pay PROGENICS within 30 days of DUPONT's receipt of a
correct PROGENICS invoice.
X. XXXXXX 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 X. XXXXXX
may return any defective or nonconforming Product to PROGENICS. Nonconformance
will mean any failure to meet specification or other manufacturing defect
that renders the
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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.
X. XXXXXX 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.
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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.
X. XXXXXX 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.
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(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
X. XXXXXX 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.
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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.
X. XXXXXX will send all notices under this Agreement to:
Attn.: CEO
Progenics Pharmaceuticals, Inc.
Xxx Xxx Xxxx Xxxxx Xxxx
Xxxxxxxxx, XX 00000
Telex (000) 000-0000
C. PROGENICS will send all notices under this Agreement to:
Attn.: Product Manager
DuPont Medical Products
000 Xxxxxx Xxxxxx
Xxxxxx, XX 00000
Telex (000) 000-0000
D. A party may designate in writing other individuals or locations to
receive notice.
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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.
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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: Xxxx X. Xxxxxx By: Xxxxx X. Xxxx
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Title: Chairman & CEO Title: Non Business District
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PROGENICS
Sheet 1
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Page 1
[***] Confidential Treatment Requested
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
[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 X.X. XxXxxx 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 Xxxxxx Xxxx,
XxXxxx Merck Pharmaceutical Co., Purchasing Department, 000 Xxxxxx Xxxx Xxxx,
Xxxxxxxxx, XX 00000.
Very truly yours,
PROGENICS PHARMACEUTICALS, INC. X.X. XXXXXX de NEMOURS & CO.
BY: /s/ Xxxx X. Xxxxxx BY: /s/ R.M. Hand
-------------------------------- ----------------------------
TITLE: Chief Executive Officer TITLE: Sr. Purchasing Agent
-------------------------------- ----------------------------
DATE: October 27, 1995 DATE: September 10, 1995
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Attach.
MATERIALS SPECIFICATION SHEET
(PURCHASED MATERIALS)
DESCRIPTION: Recombinant HIV-1 XXX xx 120
XXXXXX PART#: NEA201001EA
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SPECIFICATIONS TEST/APPROVAL CRITERIA
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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
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QUALITY CONTROL TEST/APPROVAL CRITERIA
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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
