Non-Exclusive Supply Agreement - Supergen Inc.
NON-EXCLUSIVE SUPPLY AGREEMENT
THIS AGREEMENT ENTERED INTO by and between [*] (hereinafter "[*]") with its
principal offices located at [*] and SuperGen, Inc.
(hereinafter "SuperGen") with its principal offices located at 2 Annabel Lane,
Suite 220, San Ramon, CA 94583, USA.
Whereas [*] has developed a process for the production of Paclitaxel [*] and
has sought to implement a process which meets Good Manufacturing Practices
(hereinafter "GMP") of the United States Food and Drug Administration;
Whereas SuperGen has consulted with [*] concerning the development plans for
production of Paclitaxel and other products, and has sought to assist [*] with
certain technical assistance relating to assays and stability testing resources
for this project;
Whereas SuperGen has a number of new products in Clinical trials and in other
stages of development [*];
Whereas [*] and SuperGen, both are interested in furthering a mutually
beneficial relationship particularly in relation to new products of potential
interest to both parties for development and marketing [*];
Whereas [*] and SuperGen have made disclosures to one another concerning the
future development plans for Paclitaxel and other products under development by
SuperGen and both parties favour pursuing discussions in connection with forming
particular joint projects [*] for the development and marketing of these
products [*];
Whereas [*] wishes to obtain certain advance consideration and guarantees for
the future purchase of Paclitaxel; and
Whereas SuperGen desires to secure assured supplies of Paclitaxel from a
qualified vendor on a non exclusive basis.
Now Therefore [*] and SuperGen agree as follows:
1. Definitions
A. "ANDA" shall mean Abbreviated New Drug Application.
B. "DMF" shall mean a drug master file, or its equivalent for the Product
filed with a regulatory agency by or on behalf of [*] which is adequate to
comply with the applicable requirements and standards of such regulatory agency
with respect to the Product.
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C. "FDA" shall mean the United States Food and Drug Administration.
D. "GMP" shall mean good manufacturing practices as defined by the FDA in
21 Code of Federal Regulations part 211.
E. [*]
F. "Specifications" shall mean the particulars pertaining to composition,
-------------- quality and other characteristics for the Product as set
forth in Exhibit A hereto as may be amended from time to time by mutual
agreement of the parties.
G. "USP" shall mean United States Pharmacopoeia.
H. "Product" shall mean bulk Paclitaxel.
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I. "Dollars" shall mean United States Dollars.
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2. SuperGen shall pay [*] during the GMP development process and FDA
inspection period, the sum of $1,000,000 (one million dollars) to
be applied as follows:
A. A payment of Four Hundred Thousand Dollars ($400,000) to be paid
within 30 days of the acceptance by both parties of this Agreement.
B. A payment of Three Hundred Thousand Dollars ($300,000) to be paid
within 10 days after the conclusion of accelerated stability studies at
a testing facility to be agreed upon by the parties, showing that the
Product, produced according to GMP, is stable for the period of time
recommended [*] for accelerated stability protocols. In addition
SuperGen agrees to pay for costs of stability studies on certification
batches of Paclitaxel to be performed at a laboratory mutually agreed
upon by [*] and SuperGen for such stability studies, and the cost of a
method transfer protocol up to a total up to a total of [*] dollars ($[*])
and agrees to pay fifty percent (50%) of such costs exceeding a total
of [*] dollars ($[*]) but less than a total of [*]dollars ($[*]) for a
maximum additional amount of [*] dollars ($[*]). [*] agrees to supply
the Paclitaxel and container closure system for stability studies.
C. A payment of Three Hundred Thousand Dollars ($300,000) to be paid
within 10 days after the FDA has submitted its preapproval inspection
report on [*]'s facility [*] and the FDA has indicated that it is
satisfied with [*]'s response to any deficiency, if any is cited,
observed in this FDA inspection report. [*]agrees to send to SuperGen a
copy of the FDA inspectors initial observations and the official
Establishment Inspection Report of every FDA inspection of the [*]
facility for production of Bulk Paclitaxel.
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3. SuperGen agrees to purchase a minimum of [*] of Paclitaxel before the end
of one year from the date of approval of SuperGen's ANDA for Paclitaxel
drug product. After SuperGen has purchased [*] of Paclitaxel the payments
pursuant to paragraph 2B and 2C, subject to the provisions of paragraph 7
shall be creditable against orders of Paclitaxel from [*] after commercial
production of Paclitaxel approved by the FDA has begun.
4. SuperGen agrees to an initial purchase price of [*] dollars ($[*]) per
kilogram of Paclitaxel; however, in the event that SuperGen's average
wholesale selling price to its customers of generic Paclitaxel drug product
falls below $[*] per 30 mg vial, [*] and SuperGen will implement a lower
bulk Paclitaxel purchase price which shall then be effective according to
the following schedule:
Average Wholesale Price
30 Mg/vial Paclitaxel Bulk Drug Cost (Kg)
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$[*]/30 mg vial, or higher $[*]/Kg
$[*]/30mg vial, or higher but below $[*] $[*]/Kg
$[*]/30 mg vial, or higher but below $[*] $[*]/Kg
$[*]/30 mg vial, or higher but below $[*] $[*]/Kg
Below $[*]/30 mg vial $[*]/Kg
SuperGen agrees to present in confidence to [*] reasonable evidence from
SuperGen's sales records of the immediately previous forty five days of any
average wholesale selling price decline of Paclitaxel before any price
change becomes effective.
5. SuperGen agrees to issue to [*] an irrevocable Letter of Credit on account
of a bank mutually acceptable to SuperGen and [*] in the amount of
[*] Dollars ($[*]) at the time of the payment pursuant to paragraph 2A of
this Agreement, an additional irrevocable Letter of Credit in the amount of
[*] Dollars ($[*]) at the time of payment pursuant to paragraph 2B of this
Agreement, and a further additional irrevocable Letter of Credit in the
amount of [*] Dollars ($[*]) at the time of the payment pursuant to
paragraph 2C, which shall be security for delivery of SuperGen's initial
purchase and partial subsequent purchases of Paclitaxel. The irrevocability
of the above-mentioned Letters of Credit shall be subject to the provisions
of paragraphs 7 and 12 F of this Agreement.
6. [*] shall be free to sell Paclitaxel to any party in any place for any
purpose and SuperGen shall be free to purchase Paclitaxel from third
parties.
7. If Bristol Myers-Squibb's exclusivity period for Taxol does not expire in
December 1997 because of further extension, addition or replacement by
another right or period of exclusivity, SuperGen's obligation to purchase
Paclitaxel in the agreed period shall be suspended at SuperGen's option,
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the payments under paragraph 2B and 2C shall be refunded to SuperGen, and
all of the Letters of Credit issued under paragraph 5 of this Agreement
shall become revocable by SuperGen.
8. [*] agrees to send to SuperGen a complete copy of the Analytical Methods
used to characterize the Product, complete Validation Data for the
Analytical Methods, and copy of the Environmental Impact Statement for the
Product within one month of the signing of this Agreement.
9. None of the Product supplied to SuperGen under this Agreement shall be
adulterated or misbranded within the meaning of the Federal Food, Drug and
Cosmetic Act, as amended and in effect at the time of shipment (the "ACT"),
or within the meaning of any state or municipal laws applicable to
pharmaceuticals or the Product and containing terms with substantially
similar meanings as the meanings of adulteration or misbranding under the
Act; provided however, that this provision shall not apply to, and [*]
shall have no responsibility for, misbranding caused directly by SuperGen
as a result of labels or package text specified by SuperGen for the
Product.
[*] will provide written notice to SuperGen of any proposed alterations to
the Facility or to any Product manufacturing or testing process; provided
however, that under no circumstances shall any such alteration be made
without SuperGen's prior written consent, or before regulatory approval if
required for any such alteration is received in each country in which
Product is being sold.
The parties agree to the following terms concerning shipment, delivery and
return of non-conforming Products.
A. The agreed price per kilogram of Paclitaxel pursuant to paragraph 4 of
this Agreement includes [*]'s payment of all shipping, freight forwarding
fees, taxes, customs, duties, licenses, permits and other governmental fees
and documentation [*] [*]. After delivery, SuperGen shall be
responsible for all payments of all taxes, customs, duties, licenses,
permits, and any other governmental requirements [*]. [*] and [*] agrees to
replace such Product as maybe lost in shipment at this price.
B. The shipments shall each include a complete certificate of analysis
including lot number or numbers and expiration date of not less than
eighteen (18) months from the date of arrival [*].
C. In the event that a monograph for Paclitaxel is approved by the
U.S.P., the Product shall meet any specifications of the U.S.P. monograph
and all tests used to characterize the Product described by the U.S.P.
monograph will be run in conformity with the U.S.P. prescribed tests. In
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the event that the requirements of the FDA conflict with the U.S.P.
monograph for the Product and [*]'s manufacturing and control process of
Product described in the DMF, the parties will consult to seek a mutually
acceptable solution.
D. The Product shall be delivered to SuperGen with a completed Materials
Safety Data Sheet, a letter authorizing SuperGen and its agents to refer to
the DMF filed with the FDA, a Certificate of Analysis describing all
current requirements of the Specifications, results of tests performed and
a copy of the Batch Release Sheet certifying that the batch(es) of Product
supplied has been manufactured, controlled, and released according to the
Specifications, valid DMF and all relevant and current GMP requirements at
the manufacturing facility.
E. [*] warrants that the Product is merchantable and fit for the intended
purpose of further sterile processing to make parenteral pharmaceutical
preparations, that the Product shipped in fulfilment of any order has been
made, stored, and shipped in full compliance with Current Good
Manufacturing Practices of the U.S. Food And Drug Administration and that
the Product conforms to current Specifications. Prior to each shipment of
Product, [*] shall perform quality control procedures to verify that all of
the Product to be shipped conforms fully with the Specifications.
F. SuperGen shall have 30 days from the date of delivery of the Product
to SuperGen to complete analysis of the Product. If the Product conforms to
Product Specifications agreed to by SuperGen and [*] as reflected by the
certificate of analysis, SuperGen shall authorize payment under the Letters
of Credit. If the Letters of Credit mentioned in paragraph 5 of this
Agreement are exhausted, SuperGen agrees, at its sole option, to issue a
new sufficient Letter of Credit or will tender a cash deposit in the amount
of 50% of the original purchase price at the time when order is placed. The
shipment will be delivered upon receipt of (i) the new Letter of Credit or
(ii) the deposit, and in the event that the shipment is made on deposit the
remaining 50% of the purchase price will be due within 30 days of arrival
of the shipment [*], provided that the Product conforms to
the certificate of analysis. For the analysis SuperGen agrees to use a
laboratory that has participated in and satisfactorily completed the method
transfer protocol for all methods used in the analysis of the Product.
G. If the Product fails to conform to the certificate of
analysis, SuperGen shall immediately notify the [*] and [*] offices of [*]
via facsimile, diligently investigate the failure, determine whether to
reassay or to resample and retest, and complete such reassay or retest
within six weeks of the date of receiving the Product. If the Product again
fails to conform, SuperGen shall immediately notify the [*] and [*] offices
of [*], and [*] shall replace the non-conforming Product with conforming
Product (the "First Replacement Goods") within 10 working days of such
notification. SuperGen shall have 30 days from the date of delivery of the
First Replacement Goods to SuperGen to complete analysis of the First
Replacement Goods. If the First Replacement Goods fail to conform to the
certificate of analysis, SuperGen shall immediately notify the [*] and [*]
offices of [*] via facsimile, and [*] shall replace the non-conforming
First Replacement Goods with conforming Product (the "Second Replacement
Goods") within 10 working days of such notification.
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SuperGen shall have 30 days from the date of delivery of the Second
Replacement Goods to SuperGen to complete analysis of the Second
Replacement Goods. If the Second Replacement Goods fail to conform to the
certificate of analysis, SuperGen shall immediately notify the [*] and [*]
offices of [*] via facsimile. SuperGen and [*] agree to use a laboratory
mutually acceptable to the parties which shall have authority to arbitrate
the test results and objectively determine the results of the reassay, or
resample and retest as the case may be and complete such arbitration within
10 days. If the Product is found to conform to Product Specifications then
SuperGen agrees to accept the Product and pay for the arbitration costs
incurred. If the Product is found to be non-conforming to Product
Specifications, [*] shall pay for the arbitration costs incurred. SuperGen
agrees to hold the non-conforming Product for a period of two weeks for [*]
to investigate the failure and to return the shipment of non-conforming
Product to the [*] office of [*], if [*] decides not to investigate. If
[*] cannot supply conforming goods in the First Replacement Goods and the
Second Replacement Goods shipment, or cannot make an original shipment or
replacement shipment, SuperGen shall have the right to obtain bulk
Paclitaxel from any other vendor who can supply bulk Paclitaxel meeting the
acceptance specification for Paclitaxel, and [*] shall pay the increase in
cost, if any, up to Ten Percent (10%) of the agreed original purchase price
between [*] and SuperGen and the price for the same amount of bulk
Paclitaxel ordered from [*] but obtained from a third party.
H. SuperGen agrees to initially order [*] of Paclitaxel from [*] upon FDA
approval of [*]'s manufacturing facility. At the time of the initial order,
SuperGen shall notify [*] of the amount of Paclitaxel it expects to order
for the subsequent quarter. No less than thirty days before the subsequent
quarter, SuperGen shall confirm the amount. SuperGen shall order Paclitaxel
in this manner for all orders after the initial order.
10. Representations and Warranties
A. [*] [*] represents and warrants that: (I) it has full power to enter
into this Agreement and to grant and to assign to SuperGen, Inc. the rights
granted and assigned to SuperGen Inc. hereunder. (ii) it has obtained all
necessary corporate approvals to enter into and execute the Agreement.
(iii) it has not entered and will not enter into any Agreements with any
third party that are inconsistent with this Agreement; (iv) [*] shall fully
comply with the requirements of any and all applicable federal, state,
local and foreign laws regulations, rules and orders of any governmental
body having jurisdiction over the activities contemplated by this
Agreement [*].
B. SUPERGEN SuperGen represents and warrants that (i) it has full power
to enter into this agreement; and (ii) it has obtained all necessary
corporate approvals to enter into and execute the Agreement (iii) it has
not entered and will not enter into any agreements with any third party
that are inconsistent with this Agreement; (iv) SuperGen shall fully comply
with the requirements of any and all applicable federal, sate, local and
foreign laws regulations, rules and orders of any governmental body having
jurisdiction over the activities contemplated by this Agreement [*]
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[*].
11A.SuperGen will indemnify defend and hold harmless [*] its directors,
officers, employees, agents, successors and assigns from and against any
liabilities, expenses or costs (including reasonable attorney's fees)
arising out of any claim, complaint, suit, proceeding or cause of action
against any of them by a third party alleging physical injury or death or
otherwise resulting from (i) the promotion, distribution, sale, handling,
possession or use of the Product by or on behalf of SuperGen following its
or their acceptance thereof in accordance with paragraph 9 of this
Agreement (ii) the clinical use or testing of SuperGen's pharmaceutical
products incorporating Product, (iii) the negligent or intentional wrongful
acts or omissions of SuperGen and (iv) any breach by SuperGen of its
representations and warranties under paragraph 10 of this agreement, in
each case subject to the requirements set forth in paragraph 11 C of this
agreement. Notwithstanding the foregoing, SuperGen shall have no
obligations under this paragraph for any liabilities, expenses or costs
arising out of on relating to claims covered under paragraph 11(B) below.
B. [*] shall indemnify defend and hold harmless SuperGen its directors,
officers, employees, agents, successors and assigns from and against any
liabilities, expenses or costs (including reasonable attorneys' fees)
arising out of any claim, complaint, suit, proceeding or cause of action
against any of them by a third party alleging physical injury or death or
otherwise resulting from (i) the negligent or intentionally wrongful acts
or omissions of [*]; (ii) the loss of Product for which [*] bears the risk
and (iii) any breach by [*] of paragraphs 9 and 10 of this Agreement, in
each case subject to the requirements set forth in paragraph 11 C of this
Agreement.
C. Any party seeking indemnification under this Article (the
"Indemnitee") shall (i) promptly notify the indemnifying party (the
"Indemnitor") of such claim (ii) provide the Indemnitor sole control over
the defense and or settlement thereof and (iii) at the Indemnitor's request
and expense provide full information and reasonable assistance to
Indemnitor with respect to such claims. Without limiting the forgoing with
respect to claims brought under paragraphs 11 A and 11 B above, the
Indemnitee, at its own expense shall have the right to participate with
counsel of its own choosing in the defense and/or settlement of any such
claim.
12. General Provisions
A. ASSIGNMENT. The parties agree that their rights and obligations under
this Agreement may not be assigned or otherwise transferred to a third
party without the prior written consent of the other party hereto.
Notwithstanding the foregoing, either party may transfer or assign its
rights and obligations under this Agreement to a successor to all or
substantially all of its business or assets relating to this Agreement
whether by sale, merger, operation of law or otherwise; provided that such
assignee or transferee has agreed to be bound by the terms and conditions
of this Agreement. Subject to the foregoing, this Agreement shall be
binding upon and insure to the benefit of the parties hereto, their
successors and assigns.
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B. GOVERNING LAW. This Agreement shall be governed by, and construed and
interpreted in accordance with, the laws of the State of California without
reference to conflict of laws principles [*].
C. ARBITRATION. Any dispute or claim arising out of or in connection
with this Agreement or the performance, breach or termination thereof,
shall be finally settled by binding arbitration in San Francisco,
California under the Rules of Arbitration [*] by three (3) arbitrators
appointed in accordance with said rules. The decision and/or award
rendered by the arbitrators shall be written, final and non-appealable
and may be entered in any court of competent jurisdiction. The parties
agree that, any provision of applicable law notwithstanding, they will
not request, and the arbitrator shall have no authority to award,
punitive or exemplary damages against any party. The costs of any
arbitration, including administrative fees and fees of the arbitrators,
shall be shared equally by the parties, unless otherwise determined by
the arbitrators. Each party shall bear the cost of its own attorneys' and
expert fees [*]. Notwithstanding the foregoing, either party may apply
to any court of competent jurisdiction for injunctive relief without
breach of this arbitration provision.
D. NOTICES. Any notice or report required or permitted to be given or
made under this agreement by either party shall be in writing and delivered
to the other party at its address indicated below (or to such other address
as a party may specify by notice hereunder by courier or by registered or
certified airmail, postage prepaid, or by facsimile; provided, however,
that all facsimile notices shall be promptly confirmed, in writing, by
registered or certified airmail, postage prepaid. All notices shall be
effective as of the date received by the addressee:
If to SuperGen, Inc.: SuperGen, Inc.
2 Annabel Lane, Suite 220
San Ramon, CA 94583
Attn: Dr. Joseph Rubinfeld
With a copy to: Wilson, Sonsini, Goodrich & Rosati
650 Page Mill Road
Palo Alto, California 94304-1050
Attn: Paige Maillard, Esq.
If to [*]: [*]
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With a copy to: [*]
With a copy to: [*]
E. LIMITATION OF LIABILITY. Neither party shall be liable to the other
party or any third party for any special, consequential, exemplary or
incidental damages (including lost or anticipated revenues or profits
relating to the same), arising from any claim relating to this agreement,
whether such claim is based on contract, tort (including negligence) or
otherwise, even if an authorized representative of such party is advised of
the possibility or likelihood of same. These limitations shall apply
notwithstanding the failure of the essential purpose of any limited remedy,
and the parties acknowledge that this paragraph represents a reasonable
allocation of risk.
F. FORCE MAJEURE. Neither party will be liable for its failure to perform
any of its obligations hereunder during any period in which such
performance is delayed by acts of God, fire, war, embargo, riots, strikes
or other similar cause outside the control of such party; however,
notwithstanding the forgoing, if during such period, [*] fails for 90
consecutive days to deliver Product ordered by SuperGen, the balance of any
Letters of Credit not yet drawn upon shall be revoked, and payment under
paragraphs 2 B and 2 C which has not yet been credited against Product
already delivered to SuperGen, shall be refunded by [*] to SuperGen.
G. CONFIDENTIAL TERMS. Except as expressly provided herein, each party
agrees not to disclose any terms of this Agreement to any third party
without the consent of the other party, except as required by securities or
other applicable laws, to prospective investors and to such party's
accountants, attorneys and other professional advisors.
H. HEADINGS. Headings included herein are for convenience only, do not
form a part of this Agreement and shall not be used in any way to construe
or interpret this Agreement.
I. NON-WAIVER. Any waiver of the terms and conditions hereof must be
explicitly in writing. The waiver by either of the parties of any breach of
any provision hereof by the other shall not be construed to be a waiver of
any succeeding breach of such provision or a waiver of the provision
itself.
J. SEVERABILITY. Should any section, or portion thereof, of this
Agreement be held invalid by reason of any law, statute or regulation
existing now or in the future in any jurisdiction by any court of competent
authority or by a legally enforceable directive of any governmental body,
such section or portion thereof shall be validly reformed so as to
approximate the intent of the parties
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as nearly as possible and, if unreformable, shall be deemed divisible and
deleted with respect to such jurisdiction, but the Agreement shall not
otherwise be affected.
K. INDEPENDENT CONTRACTORS. The relationship of SuperGen, Inc. and [*]
established by this Agreement is that of independent contractors. Nothing
in this Agreement shall be construed to create any other relationship
between SuperGen, Inc., and [*]. Neither party shall have any right, power
or authority to assume, create or incur any expense, liability or
obligation, express or implied on behalf of the other.
L. ENTIRE AGREEMENT. The terms and provisions contained in the Agreement,
including the Exhibits hereto, constitute the entire Agreement between the
parties and shall supersede all previous communications, representations,
Agreements or understandings, either oral or written, between the parties
with respect to the subject matter hereof. No Agreement or understanding
varying or extending this Agreement shall be binding upon either party
hereto, unless set forth in a writing which specifically refers to the
Agreement signed by duly authorized officers or representatives of the
respective parties, and the provisions hereof not specifically amended
thereby shall remain in full force and effect.
M. COUNTERPARTS. This Agreement may be executed in counterparts, each of
which shall be deemed an original, but which together shall constitute one
and the same instrument.
The forgoing is AGREED and ACCEPTED
For [*] For SuperGen
/s/ Dr. Joseph Rubinfeld
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[*] Dr. Joseph Rubinfeld
President and Chief Executive Officer President and Chief Executive
Officer
[*] SuperGen, Inc.
May 7, 1997 May 7, 1997
- ----------------------------------- ------------------------------
Date Date
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EXHIBIT A
Specification
The Product shall have the following minimum characteristics and limits
specified in the certificate of analysis and these limits, unless otherwise
agreed to between the parties, shall be SuperGen's acceptance criteria for the
Product:
1. Identity: [*]
2. Appearance:
3. Potency by HPLC: [*]
4. Related Substances: [*]
5. Moisture:
Both parties agree to further discuss the viability and necessity of including
batch information on the following characteristics of the Product: Specific
Rotation, Crystallinity, Residual Solvent, pH, Residue on Ignition, Heavy
Metals, Microbiological Counts and Endotoxin. [*] agrees to make its best effort
to ensure that any or all of the above characteristics required by FDA will meet
with FDA standards. SuperGen agrees to provide [*] with technical assistance in
finding the best method development for acquiring information on these
characteristics.