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Exhibit 10.31
NOTE: CERTAIN PORTIONS OF THE EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR
CONFIDENTIAL TREATMENT. THE OMITTED PORTIONS HAVE BEEN SEPARATELY FILED WITH THE
COMMISSION.
SUPPLY AGREEMENT
This Agreement is made this 4 day of DEC, 1994 by and between Iomed, Inc.
("Iomed"), 0000 Xxxx 0000 Xxxxx, Xxxx Xxxx Xxxx, Xxxx 00000 and Luitpold
Pharmaceuticals, Inc./American Regent Laboratories Inc., ("American Regent Inc.
or Luitpold") 0 Xxxxxxxx Xxxxx, Xxxxxxx, XX 00000. Iomed and American Regent
Inc. or Luitpold, for the purposes of this Agreement, may be referred to jointly
as the "Parties".
Iomed desires to purchase its requirements of Dexamethasone 0.4% injection,
USP, from American Regent Inc. and American Regent Inc. agrees to sell to Iomed
its requirements of such Product. Iomed will market the Product for use in
conjunction with Iomed's Iontophoretic Delivery System.
Therefore, in consideration of the premises and the mutual promises and
agreements contained herein, Iomed and American Regent Inc. agree as follows:
1. Product.
For purposes of this Agreement, the term "Product" shall mean Dexamethasone
Sodium Phosphate 0.4% injection, USP, packaged on 30ml SVP fliptop containers
(ANDA#87-440) and labeled for iontophoretic administration with Iomed's
Iontophoretic Delivery System. A single 30ml SVP fliptop container of Product is
referred to as a "Unit" for the purposes of this Supply Agreement.
2. Custom Product Development.
Promptly after the execution of this Agreement, the Parties shall undertake
to develop a custom labeled packaged product suitable for marketing with Iomed's
Iontophoretic Delivery System and suitable for manufacturing on American Regent
Inc.'s standard packaging equipment for fliptop containers. The Parties shall
use their reasonable best efforts to successfully complete the product
development and to obtain U.S. Food and Drug Administration ("FDA") marketing
approval of the Product. It is understood and agreed that
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there is no guarantee that the product development will be successful and no
representation or warranty of any kind is given by either party that a
marketable Product will result from the development.
3. American Regent Inc.'s Responsibilities.
The objective of the product development shall be for American Regent Inc.
to assist Iomed as required in obtaining regulatory approval for sale of the
Product. The Product will then be manufactured by American Regent Inc. and sold
to Iomed for resale by Iomed. American Regent Inc. shall have the following
development responsibilities:
a. Manufacture at American Regent Inc.'s plant, ***** Units of Product (at
a price of *****/Unit to Iomed) for use in clinical studies to be carried out by
Iomed to support FDA filings for device and drug labeling approvals.
b. Provide authorization to Iomed to reference Luitpold's Abbreviated New
Drug Application (#87-440), as appropriate for Pre-market Approval submissions
by Iomed. Assist Iomed, as reasonably requested, in preparation of regulatory
submissions for the Product and provide such other assistance as Iomed may
reasonably require.
c. Using American Regent Inc.'s graphics studio, typeset final label and
carton copy from artwork provided by Iomed and generate proofs and negatives
suitable for printing.
4. Iomed's Regulatory Submissions.
Iomed agrees that American Regent Inc. shall have the right to copies of
Iomed's proposed Pre-market Approval submissions. Iomed further agrees that
American Regent Inc. shall participate with Iomed in responding to questions
from the FDA regarding regulatory submissions applicable to the Product. Iomed
shall respond to questions relating to its device and the clinical studies.
American Regent Inc. shall respond to questions relating to the Product.
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5. Manufacture and Supply of Product.
5.1 Purchase and Sale of Product - Iomed Requirements. During the term
of this Agreement and pursuant to the terms and conditions hereof, American
Regent Inc. agrees to manufacture, sell and deliver Product exclusively to
Iomed and Iomed agrees to purchase its total requirements of Product from
American Regent Inc.
5.2 Orders and Delivery Variances. Unless otherwise agreed to by the
Parties, an order quantity, if any, shall be in multiples of ***** Units
and in quantities not less than ****** Units. The maximum order quantity
shall be ******* Units per month. The maximum and minimum order sizes may
be adjusted from time to time by written agreement of the Parties. Delivery
of Product by American Regent Inc. may vary from quantities ordered by
Iomed by plus or minus *** percent *****. Such deliveries shall be in full
compliance with this Agreement.
5.3 Manufacture of Product.
5.3.1 Luitpold shall manufacture Product in accordance with the
Product Specifications for American Regent Inc., Product Number
4930-25. Such Product Number may be modified from time to time by
Luitpold. The Product shall be labeled by American Regent Inc. in
accordance with FDA approved label copy and as mutually approved by
the Parties.
5.3.2 Luitpold's quality control procedures and in-plant quality
control checks on the production of Product for Iomed shall be applied
in the same manner as those procedures and checks are applied to
products manufactured for sale directly by American Regent Inc. as
American Regent Inc. products. Luitpold shall provide a certificate of
analysis with each shipment of Product.
5.3.3 Iomed shall have a period of ************* days from the
date of receipt to inspect and reject any shipment of Product on the
grounds that it does not conform with the Product Specifications.
Iomed shall have the right to return any Product which does not
conform. All or part of any shipment may be held for Luitpold's
disposition if found to be not in conformance with the Product
Specifications, provided Luitpold confirms
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such nonconformance through generally accepted quality control
procedures. Luitpold shall have ********** days from the
effective date of rejection (written notice) by Iomed in which to
confirm nonconformance. Failure to confirm within such **********
day period shall constitute agreement with Iomed's rejection of
Product. Luitpold may, at its discretion, send Product to an
independent third party for analysis of conformance. After Luitpold
confirms nonconformance, Luitpold shall have a period of **********
days to replace such nonconforming Product. Replacement with
conforming Product shall be Iomed's sole and exclusive remedy for any
nonconforming Product delivered hereunder. Shipment of rejected
Product to American Regent Inc. and shipment of replacement Product to
Iomed shall be at American Regent Inc.'s expense and by the carrier
designated by American Regent Inc.
5.3.4 American Regent Inc. hereby approves placement of a
descriptive private label with Iomed's trademark and/or Iomed's
trademark on the Product. Any material changes to the descriptive
label must be approved by American Regent Inc. prior to implementing
such changes.
5.4 Price and Payment
5.4.1 Product shall be delivered by American Regent Inc. at
prices set forth in Exhibit A of this Agreement. The prices are based
on standard American Regent Inc. packaging components with custom
Iomed print copy as approved by American Regent Inc. for
manufacturability.
5.4.2 American Regent Inc. shall invoice Iomed upon delivery of
Product. *****
5.4.3 Any federal, state, county or municipal sales or use tax,
excise or similar charge, or any other tax assessment (other than that
assessed against income), license or other
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charge lawfully assessed and normally charged on the manufacture,
sale or transportation of Product sold pursuant to this Agreement
shall be paid by Iomed.
5.5 Delivery.
Product shall be delivered to Iomed, or an Iomed designee, F.O.B.
plant and title shall pass to Iomed at such point.
5.6 Orders and Forecasts.
5.6.1 American Regent Inc. and Iomed shall cooperate fully in
estimating and scheduling production for the first firm order to be
placed by Iomed. The first firm order shall cover a period of three
(3) consecutive calendar months, Thereafter, firm orders shall be
placed monthly and shall cover the next succeeding third month. At the
time Iomed places its firm monthly orders, Iomed shall provide to
American Regent Inc. Iomed's estimate of its monthly requirements for
the next succeeding nine (9) calendar month period. It is the intent
that at all times American Regent Inc. shall have in hand firm monthly
orders covering the current three (3) calendar month period and
Iomed's estimates of its monthly requirements for the next succeeding
nine (9) calendar month period.
5.6.2 Each Iomed purchase order for Product shall be governed by
the terms of this Agreement and none of the provisions of such
purchase order shall be applicable except those specifying quantity
ordered, delivery dates, shipping instructions and invoice
information.
5.7 Guarantees and Warranties.
5.7.1 Luitpold guarantees to Iomed that Product delivered to
Iomed pursuant to this Agreement shall, at the time of delivery, not
be adulterated or misbranded within the meaning of the Federal Food,
Drug, and Cosmetic Act, as amended, or within the meaning of any
applicable state or municipal law in which the definitions of
adulteration and misbranding are substantially the same as those
contained in the Federal Food, Drug, and Cosmetic Act, as such Act and
such laws are constituted and effective at the time of
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delivery and will not be an article which may not under the provisions
of Sections 404 and 505 of such Act be introduced into interstate
commerce.
5.7.2 Luitpold warrants that Product delivered to Iomed pursuant
to this Agreement shall conform with the Product Specifications and
shall have been manufactured pursuant to current Good Manufacturing
Practice, as prescribed by regulations promulgated by the FDA.
American Regent Inc. makes no other warranties, express or implied,
with respect to the product. All other warranties, express or implied,
including without limitation the implied warranties of
merchantability and fitness for a particular purpose are hereby
disclaimed by American Regent Inc.
5.7.3 Luitpold shall indemnify and hold Iomed harmless from and
against all liability, loss or damage (including reasonable attorney
fees) which Iomed may incur, or be required to pay by reason of any
injury, illness and/or death that resulted from negligent or wrongful
acts or omissions of Luitpold. Iomed shall indemnify and hold
Luitpold harmless from and against any and all liability, loss or
damage (including reasonable attorney fees) which Luitpold may incur,
or be required to pay by reason of any injury, illness and/or death
that resulted from negligent or wrongful acts or omissions of Iomed,
or the safety or efficacy of the Product when used with Iomed's
iontophoretic administration devices as approved for use with the
Product. The obligations of the indemnifying party under this
paragraph are conditioned upon the prompt, written notification to
the indemnifying party of any of the aforementioned suits or claims,
upon the full cooperation of the indemnified party in the
investigation, defense and proposed settlement of such suits or
claims and the indemnifying party being given the opportunity to
defend. Such notification must be provided to the indemnifying party
within forty-five (45) days of the event giving rise to such notice.
This provision for indemnification shall be void and there shall be
no liability against a party as to any suit or claim for which
settlement or compromise is made without the prior consent of the
indemnifying party.
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6. Term and Termination.
6.1 This Agreement shall commence on the date first above written and
the initial term shall expire on January 1, 2005. Thereafter, the term
shall continue automatically until terminated. This agreement may be
terminated on January 1, 2005 or at anytime thereafter upon not less than
one hundred eighty (180) day's prior written notice from one party to the
other. Iomed may terminate this Agreement at any time by giving American
Regent Inc. one hundred eighty (180) days prior written notice if Iomed
discontinues sale of its Iontophoretic Delivery System for the Product.
6.2 Either party may terminate this Agreement by giving to the other
sixty (60) days prior written notice as follows:
a. Upon the bankruptcy or the insolvency of the other party; or
b. Upon the breach of any warranty or any other material
provision of this Agreement by the other party if the breach is not
cured within sixty (60) days after written notice thereof to the party
in default.
6.3 Termination, expiration, cancellation or abandonment of this
Agreement through any means and for any reason shall not relieve the
Parties of any obligation accruing prior thereto and shall be without
prejudice to the rights and remedies of either party with respect to any
antecedent breach of any of the provisions of this Agreement.
7. Force Majeure.
Any delay in the performance of any of the duties or obligations of either
party hereto (except the payment of money) shall not be considered a breach of
this Agreement and the time required for performance shall be extended for a
period equal to the period of such delay, provided that such delay has been
caused by or is the result of any acts of God; acts of the public enemy;
insurrections; riots; embargoes; labor disputes, including strikes, lockouts,
job actions, or boycotts; fires; explosions; floods; shortages of material or
energy; or other
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unforeseeable causes beyond the control and without the fault or negligence of
the party so affected. The party so affected shall give prompt notice to the
other party of such cause, and shall take whatever reasonable steps are
necessary to relieve the effect of such cause as rapidly as possible.
8. Confidential Information.
8.1 It is recognized by the Parties that during the term of this
Agreement the Parties may exchange Confidential Information. Each party
agrees not to disclose to any third person Confidential Information
received from the other party and not to use Confidential Information
received from the other party, except as authorized by the disclosing
party. For purposes of this Agreement, Confidential Information shall
include all information disclosed hereunder in writing and identified as
being confidential or if disclosed orally is reduced to writing within
thirty (60) days of oral disclosure and identified as being confidential,
except any portion thereof which:;
a. is known to the recipient before receipt thereof under this
Agreement;
b. is disclosed in good faith to the recipient after acceptance
of this Agreement by a third person lawfully in possession of such
information and not under an obligation of nondisclosure;
c. is or becomes part of the public domain through no fault of
the recipient;
d. is developed by the recipient independently of and without
reference to Confidential Information; or
e. is required by law to be disclosed.
Notwithstanding the above, nothing contained in this Agreement
shall preclude Iomed or America Regent Inc. from utilizing
Confidential Information as may be necessary in prosecuting patent
rights of the Parties, or obtaining governmental marketing approvals,
or in manufacturing Product pursuant to this Agreement. The
obligations of the Parties relating to Confidential Information shall
expire three (3) years after the termination of this Agreement.
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9. Independent Contractors.
The relationship of Iomed to American Regent Inc. established by this
Agreement is that of an independent contractor. Nothing contained in the
Agreement shall be construed to constitute Iomed as a partner, agent or joint
venturer with American Regent Inc. or as a participant in a joint or common
undertaking with American Regent Inc.
10. Notices
All notices hereunder shall be delivered personally or by registered or
certified mail, postage prepaid, to the following addresses of the respective
Parties:
American Regent Inc.
0 Xxxxxxxx Xxxxx
Xxxxxxx, XX 00000
Attention: Xxxx Xxxx Xxxxxxx, VP Sales & Marketing
With copy to: Xxxx Xxxxx, VP of Manufacturing
Iomed, Inc.
0000 Xxxx 0000 Xxxxx
Xxxx Xxxx Xxxx, Xxxx 00000
Attention: General Manager, Rehabilitative Medicine
With copy to: Vice President Operations
Notices shall be effective upon receipt if personally delivered, or on the
third business day following the date of mailing. A party may change its address
listed above by written notice to the other party.
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11. Applicable Law.
This Agreement shall be construed, interpreted and governed by the laws of
the State of New York, except for choice of law rules.
12. Assignment.
Neither party shall assign this Agreement or any part thereof without the
prior written consent of the other party; provided, however, American Regent
Inc. may assign this Agreement to a wholly-owned subsidiary and either party,
without such consent, may assign or sell the same in connection with the
transfer or sale of substantially its entire business to which this Agreement
pertains or in the event of its merger or consolidation with another company.
Any permitted assignee shall assume all obligations of its assignor under this
Agreement. No assignment shall relieve any party of responsibility for the
performance of any accrued obligation which such party then has hereunder.
13. Entire Agreement.
This Agreement constitutes the entire agreement between the Parties
concerning the subject matter hereof and supersedes all written or oral prior
agreements or understandings with respect thereto. No course of dealing or usage
of trade shall be used to modify the terms hereof.
14. Severability.
This Agreement is subject to the restrictions, limitations, terms and
conditions of all applicable laws, governmental regulations, approvals and
clearances. If any term or provision of this Agreement shall for any reason be
held invalid, illegal or unenforceable in any respect, such invalidity,
illegality or unenforceability shall not affect any other term or provision, to
the extent the same shall have been held to be invalid, illegal or
unenforceable, had never been contained herein.
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15. Waiver - Modification of Agreement.
No waiver or modification of any of the terms of this Agreement shall be
valid unless in writing and signed by authorized representatives of both
Parties. Failure by either party to enforce any rights under this Agreement
shall not be construed as a waiver of such rights nor shall a waiver by either
party in one or more instances be construed as constituting a continuing waiver
or as a waiver in other instances.
16. Product Recalls.
If (a) any government authority issues a request, directive or order that
the Product be recalled, or (b) a court of competent jurisdiction orders such a
recall, or (c) Iomed or American Regent Inc. reasonably determine after
consultation with the other that the Product should be recalled, the Parties
shall take all appropriate corrective actions. If such recall results from any
course or event for which American Regent Inc. is responsible, American Regent
Inc. shall be responsible for the expenses of recall. In all other cases, Iomed
shall be responsible for the expenses of recall. For the purposes of this
Agreement, the expenses of recall shall include, without limitation, the
reasonable expenses of notification and destruction or return of the recalled
Product and the costs for the Product recalled which shall be equal to the
purchase price paid for such Product. The Parties intending to be bound by the
terms and conditions hereof have caused this Agreement to be signed by their
fully authorized representatives on the date first above written.
17. Product Liability.
Both Luitpold and Iomed will maintain product liability insurance for the
Product of not less than **********.
The parties intending to be bound by the terms and conditions hereof have
caused this Agreement to be signed by their fully authorized representatives on
the date first above written.
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IOMED. INC. LUITPOLD PHARMACEUTICALS, INC.
AMERICAN REGENT LABORATORIES INC.
By: /s/ Xxx X. Xxxxxxxxxxx By: /s/ Xxxxx Xxxxx
----------------------- ----------------
Xx. Xxx X. Xxxxxxxxxxx Xx. Xxxxx Xxxxx
President & CEO President & CEO
Date: November 22, 1994 Date: Dec 4 1994
----------------- ----------
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Exhibit A
PRICE
Price per Unit for the 30 mL fliptop container of Product is as follows:
QUANTITY PER ORDER PRICE/UNIT
-------------------- ----------
10,000-74,999 Units ****
74,999-120,000 Units ****
1) Prices are based on Product purchased for delivery for each order. Iomed
shall provide firm orders and forecasts as per paragraph 5.6.1.
2) Beginning January 1, 1996, and on each succeeding January 1 during the
term hereof, prices may be adjusted by American Regent Inc. Any such adjustment
shall be ****.
The Product will be bulk packaged.
Product Inserts will be provided by American Regent Inc., at our cost, to
Iomed, if requested by Iomed.
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