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Exhibit 10.64
CERTAIN PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED BASED UPON A REQUEST FOR
CONFIDENTIAL TREATMENT PURSUANT TO RULE 24b-2 UNDER THE SECURITIES EXCHANGE
ACT OF 1934. THE OMITTED PORTIONS HAVE BEEN FILED SEPARATELY WITH THE
SECURITIES AND EXCHANGE COMMISSION.
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 406 under the Securities Act of 1933 and has been filed
separately with the Securities and Exchange Commission.
MEDIMMUNE, INC.
DISTRIBUTION AGREEMENT
This Agreement made as of August 16, 1999, (hereinafter "EFFECTIVE DATE")
between MedImmune, Incorporated (MEDIMMUNE), Xxxxxxxxxxxx, Xxxxxxxx, 00000, and
Nova Factor including its affiliates referred to on the attached Exhibit A,
with main offices located at 0000 Xxxxxxx Xxxxxx Xxxxxxx, Xxxxx 000, Xxxxxxx,
XX 00000 (DISTRIBUTOR).
Pursuant to this Agreement, MEDIMMUNE appoints DISTRIBUTOR as a * distributor
in the continental United States, Alaska, Hawaii and Puerto Rico (TERRITORY)
for its humanized monoclonal antibody product sold under the trademark
Synagis(R) (hereafter "PRODUCT(S)"). The parties hereto, intending to be
legally bound, hereby agree as follows:
I. OBLIGATIONS OF MEDIMMUNE:
A. Shipment and Pricing to DISTRIBUTOR
MEDIMMUNE shall sell to DISTRIBUTOR and ship the PRODUCT to
the above address and to addresses specified in Exhibit A.
MEDIMMUNE shall charge the DISTRIBUTOR for the PRODUCT in
accordance with the prices and policies shown in Addendum II
plus all applicable Federal and State Taxes in effect on the
date of each shipment of the PRODUCT. Addendum II, which may
be modified from time to time by MEDIMMUNE, is attached to
this Agreement and incorporated by reference. MEDIMMUNE shall
extend the Distributor Price to the DISTRIBUTOR for the sales
of the PRODUCT to * market segment and for * of the PRODUCT as
defined in Section II.F.4.
B. * Pricing
For MEDIMMUNE PRODUCTS sold and shipped from DISTRIBUTOR's
inventory * and has provided * which requires DISTRIBUTOR to
accept a * , DISTRIBUTOR shall be * (hereinafter
"CHARGEBACK(S)").
C. Payment
Payment shall be rendered according to the conditions stated
in Addendum II.
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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D. PRODUCT Recalls
MEDIMMUNE shall compensate DISTRIBUTOR for the expense
incurred in performing all requested recall services not due
to DISTRIBUTOR's negligence, willful misconduct or illegal
misconduct. Such compensation shall be limited to expenses
incurred for recall services directly related to
DISTRIBUTOR'S inventory in DISTRIBUTOR'S possession, unless
MEDIMMUNE requests additional recall services in writing from
DISTRIBUTOR.
D. Warranty/Indemnity
MEDIMMUNE warrants that the PRODUCT is manufactured and
distributed in conformance with the *. MEDIMMUNE shall defend
and hold harmless * or from any other claim relating to the
failure of *, provided, however, that MEDIMMUNE has promptly
been notified in writing of such suit, claim, or proceeding
and is given full and complete authority (including settlement
authority), by DISTRIBUTOR or its directors, employees or
agents; is given information and assistance by DISTRIBUTOR for
such defense; further provided that no admission is made
without the consent of MEDIMMUNE and its insurers; further
provided that * according to the indemnification obligations
of this Agreement and such * approved of by MEDIMMUNE.
E. Title, Insurance, and Delivery
Titles*
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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II. OBLIGATIONS OF DISTRIBUTOR:
A. Payment for the PRODUCT
DISTRIBUTOR shall pay for all regular orders purchased by
DISTRIBUTOR, with payment to be rendered according to the
conditions stated in Addendum II. Orders shipped directly to
DISTRIBUTOR's customers at DISTRIBUTOR's request shall be
considered as those of DISTRIBUTOR and DISTRIBUTOR shall be
responsible for the payment of such orders. All invoices must
be paid in full under the terms specified in Addendum II and
no deductions, other than cash discounts, are permitted from
MEDIMMUNE invoices unless authorized by a prior credit memo.
In the event DISTRIBUTOR fails to render payment for an order
of the PRODUCT as required, MEDIMMUNE shall have the right to
withhold future shipments of the PRODUCT until the
outstanding balance or balances have been paid.
B. Financial and Credit Position
DISTRIBUTOR shall maintain an adequate financial condition
satisfactory to MEDIMMUNE and substantiate such a condition
with audited financial statements of DISTRIBUTOR's parent
corporation or as otherwise reasonably requested by
MEDIMMUNE. If, in MEDIMMUNE's judgment, at any time before
shipment, the financial responsibility of the DISTRIBUTOR
becomes impaired or unsatisfactory to MEDIMMUNE, MEDIMMUNE
shall have the right to require cash payment or appropriate
security before shipment or shall have the right to refuse to
accept the order.
C. Payment of Unearned Cash Discounts
DISTRIBUTOR shall reimburse MEDIMMUNE for any cash discounts
taken but not earned. MEDIMMUNE will issue a second invoice
for the Unearned Cash Discount for which DISTRIBUTOR shall
make payment within 10 (ten) days of receipt of invoice.
D. Ordering
DISTRIBUTOR shall transmit MEDIMMUNE orders either direct via
EDI, fax, or phone. All orders submitted by DISTRIBUTOR shall
have the purchase order number clearly indicated.
E. Inventory
1. DISTRIBUTOR * from MEDIMMUNE according to the terms
of Addendum II and the rest of this Agreement.
DISTRIBUTOR *. In the event that MEDIMMUNE is unable
to fill an order for DISTRIBUTOR, then
*Omitted Information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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* DISTRIBUTOR shall not purchase or attempt
to purchase PRODUCT which has*.
2. MEDIMMUNE shall be entitled to reasonably request, at
any time, information regarding inventory levels of
PRODUCT, *. DISTRIBUTOR shall have the * this
information from either computer records or actual
physical inventory count. Upon reasonable notice,
MEDIMMUNE shall also have the right to inspect
DISTRIBUTOR's business records.
3. DISTRIBUTOR shall report its* in accordance
with Addendum IV, except for sales information
pertaining to *.
4. DISTRIBUTOR shall maintain sufficient inventory of
the PRODUCT to promptly and adequately supply the
demand of its customers.
F. Services/SALES
1. DISTRIBUTOR shall provide sales support for the
PRODUCT as well as the order-taking and delivery
services necessary to meet reasonable needs of
customers for the PRODUCT.
2. DISTRIBUTOR shall provide Marketing and Sales
support for the PRODUCT as required in Addendum IV
attached to this Agreement and incorporated by
reference.
3. DISTRIBUTOR shall sell the PRODUCT * market in the
TERRITORY. Unless DISTRIBUTOR has obtained the prior
written authorization of MEDIMMUNE, * . DISTRIBUTOR
shall not sell the PRODUCT * . DISTRIBUTOR shall not
offer PRODUCT * .
4. "* DISTRIBUTION" shall mean supply of the PRODUCT by
DISTRIBUTOR in response to * of the PRODUCT in a * to
a * or other * (hereinafter
* Omitted Information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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* in exchange for * corresponding to the *
a.) MEDIMMUNE and DISTRIBUTOR shall cooperate
in the sharing of information regarding
* and other information bearing upon each
party's obligations under this Agreement.
However, * shall in no way or manner * for
any failure by * to obtain *.
G. Pricing to Customers
1. Pricing of the PRODUCT by DISTRIBUTOR shall be
consistent with the terms of Addendum IV.
H. * PRICING
1. DISTRIBUTOR * presented by * customers.
2. DISTRIBUTOR shall provide MEDIMMUNE with an
accounting of * for * and the * to * at the end of
each *.
I. Lawful Handling
1. With respect to the PRODUCT, DISTRIBUTOR shall take
such precautions as are reasonably necessary to
prevent its use, distribution or sale by those who
may not lawfully possess, use, handle, distribute or
sell the PRODUCT, and DISTRIBUTOR will fully comply
with applicable local, state, and federal laws.
2. DISTRIBUTOR shall maintain all federal, state, and
local registrations necessary for the lawful
handling of the PRODUCT and immediately notify
MEDIMMUNE of any denial, revocation or suspension of
any such registration or any changes in the PRODUCT.
J. Proper Handling and Storage
DISTRIBUTOR shall handle and store the PRODUCT in a clean and
orderly location and in a manner which will assure that the
proper rotation and quality of the PRODUCT is maintained and
that PRODUCT is in compliance with all applicable federal,
state and local regulations. DISTRIBUTOR shall comply with
MEDIMMUNE criteria on storage and shipping the PRODUCT that
require special handling as provided in Addendum III attached
to this Agreement and incorporated by reference. DISTRIBUTOR
shall allow physical inspection of storage facilities at any
reasonable time MEDIMMUNE requests upon 10 (ten) business
days
* Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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prior notice from MEDIMMUNE, DISTRIBUTOR shall in no way or
manner be permitted to repackage the PRODUCT.
K. Substitution
DISTRIBUTOR shall fill orders for the PRODUCT, only with the
PRODUCT. DISTRIBUTOR shall not substitute any orders for the
PRODUCT with products other than the PRODUCT.
L. Transfer of Ownership - Change in Address DISTRIBUTOR shall
notify MEDIMMUNE of the terms and conditions of any transfer
in majority ownership or control, or any change in address,
within a reasonable time prior to such action.
III. RETURNS
A. * shall be entitled to return for * from DISTRIBUTOR's
inventory that has * the * or PRODUCT that * when *. *. In any
and all other cases, MEDIMMUNE will not accept returns from
customers of DISTRIBUTOR. * that are a result of returns are
the responsibility of *. Furthermore, MEDIMMUNE will not
accept merchandise that has been *. All returns require prior
approval by MEDIMMUNE. No other returns will be accepted.
B. * only will be issued for returns or claims of *. Proper
documentation, including certification that * for returns of
expired PRODUCT, must accompany every return or claim. * for *
will only be issued after MEDIMMUNE has received the * from
DISTRIBUTOR. DISTRIBUTOR shall report all claims for returns
of PRODUCT shipped by MEDIMMUNE * of the receiving date.
Deductions on * will not be permitted.
C. The provisions of this section of further subject to those of
*.
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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IV. GENERAL PROVISIONS
A. All orders are subject to acceptance and approval by
MEDIMMUNE.
B. Neither MEDIMMUNE nor DISTRIBUTOR shall be liable to the
other for failing to do as agreed where such failure is the
result of a strike or other labor disturbance, fire, flood,
earthquake, storm, governmental action, or other reason
beyond its control.
C. In the event there is a shortage of the PRODUCT, MEDIMMUNE
shall have the right to prorate the PRODUCT among its
DISTRIBUTORS in such a manner as it, in its sole discretion,
deems to be in the public interest.
D. MEDIMMUNE reserves the right to fill only as much of a
DISTRIBUTOR'S order as MEDIMMUNE, in its sole discretion,
determines represents DISTRIBUTOR'S bona fide current
requirements for the PRODUCT; and MEDIMMUNE may exercise such
right whether or not it has announced a forthcoming price
increase for the PRODUCT.
E. No business unit, subsidiary, affiliate, division or
operation conducted by DISTRIBUTOR other than those listed on
Exhibit A shall be bound by the terms and conditions, or
entitled to the rights, of this Agreement. Nova Factor shall
be liable for any and all breaches or failures, including the
failure to render payment for the PRODUCT, committed by the
entities listed on Exhibit A.
F. This Agreement may be changed or amended only in writing
signed by duly authorized representatives of MEDIMMUNE and
DISTRIBUTOR, and in the case of MEDIMMUNE, only by an
authorized representative from its office in Gaithersburg.
All attachments and addenda to this Agreement are hereby
incorporated by reference.
G. This Agreement, and any rights or obligations hereunder,
shall not be assigned by either party without the written
consent of the other party, except that either party may
otherwise assign its respective rights and transfer its
respective duties to any assignee of all or substantially all
of its business (or that portion thereof to which this
Agreement relates) that is not a subsidiary or division of
its parent corporation or in the event of its merger or
consolidation or similar transaction with a business entity
other than a subsidiary or division of its parent
corporation. Either party may assign its respective rights
and/or transfer its respective duties to a subsidiary or
division of its parent corporation only upon the written
permission of the other party which shall not be unreasonably
withheld.
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H. This Agreement shall terminate automatically on the one year
anniversary of the EFFECTIVE DATE. However, this Agreement
may be renewed at MEDIMMUNE's sole discretion. During its
term, the Agreement may be terminated by either party upon
thirty (30) days written notice mailed to the other at the
address set forth above or terminated immediately for any
breach of the terms and conditions of this agreement.
I. During the term of the Agreement, each party may find it
necessary to disclose confidential and proprietary
information to the other (hereinafter "INFORMATION"). The
INFORMATION may include but not be limited to pricing
generally, SPECIAL CONTRACT PRICING, price quotations for the
PRODUCT by DISTRIBUTOR or MEDIMMUNE, delivery schedules,
manufacturing schedules, sales amounts and sales figures.
During the term of this Agreement and for 5 (five) years
thereafter, irrespective of any termination earlier than the
expiration of the term of this Agreement, each party shall
maintain the INFORMATION in confidence and shall not reveal
the INFORMATION to third parties without the written consent
of the disclosing party, except as required by law,
regulation, or legal process. These restrictions shall not
apply to INFORMATION that:
a) becomes public knowledge without the fault
of the receiving party;
b) is already in the possession of the
receiving party as shown by competent
evidence;
c) is disclosed to the receiving party by a
third party with no obligation to the
disclosing party to maintain its
confidentiality.
d) is independently developed by the receiving
party without reference to the INFORMATION
of the other party.
J. This Agreement supersedes all prior contracts, agreements,
and understandings between MEDIMMUNE and DISTRIBUTOR with
regard to its subject matter.
K. This Agreement shall be construed in accordance with, and
governed by, the laws of the State of Maryland.
L. Unauthorized deductions are in violation of this Agreement
and will result in delayed shipments or canceled orders.
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IN WITNESS WHEREOF, the parties hereto have executed this DISTRIBUTOR
AGREEMENT as of the date set forth above.
MEDIMMUNE DISTRIBUTOR
By: /s/ Xxxxx X. Xxxxxx By: /s/ Xxxxx Grow
--------------------------------- ---------------------------------
Xxxxx X. Xxxxxx
Title: Executive Vice President, Title:
Sales and Marketing
Date: 8/17/99 Date: 8/13/99
------------------------------- -------------------------------
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ATTACHMENTS:
Addendum I: Returns Policy
Addendum II: Distributor Price List and Terms
Addendum III: Storage and Shipping Guidelines
Addendum IV: Distributor Program Requirements
Addendum V: Distributor * Requirements
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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ADDENDUM I
RETURNS POLICY
--------------------------------------------------------------------------------
MedImmune, Inc. Return Policy and Instructions:
--------------------------------------------------------------------------------
Returnable PRODUCT:
- * that are * and have been *. (* must be documented.)
- * from MEDIMMUNE and * is reported * of receipt.
No other returns are accepted.
These procedures must be followed when returning Synagis(R):
- Contact MEDIMMUNE Customer Service at 1(877)633-4411 to obtain a
Return Authorization Form.
- COMPLETELY fill out the Return Authorization form, including
*, courier, pick-up date and signature.
- INCLUDE THE RETURN AUTHORIZATION FORM AND * WITH EACH
RETURN. NO returns will be accepted without the form. Please
reference the Return Authorization document number on your *.
- FOLLOW THE ATTACHED PACKAGING INSTRUCTIONS FOR EACH TYPE OF
RETURN.
- The Wholesaler has agreed to maintain * and * necessary for the *
of this product. Therefore, *, will not be honored.
- If any of the above procedures have not been followed, MedImmune
will not be held responsible * of merchandise.
- RETURN SHIPMENTS WILL ONLY BE RECEIVED BY MEDIMMUNE DURING THE
HOURS OF 9:00 A.M. TO 5:00 P.M. MONDAY THROUGH FRIDAY, EXCEPT ON
HOLIDAYS. DO NOT SHIP RETURNS ON FRIDAYS!
Please contact MedImmune Customer Service at 0(000)000-0000, if you have
any questions. Thank you.
MedImmune Fax number: (000) 000-0000
*
NO EXCEPTIONS!!!!!!
* Omitted information is the subject of a request for confidential treatment
pursuant to the Rule 24b-2 under the Securities Exchange Act of 1934 and has
been filed separately with the Securities and Exchange Commission.
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ADDENDUM II
DISTRIBUTOR PRICING (CURRENT AS OF MAY 1, 1999)
SYNAGIS(R) (NDC 60574-4111-1), (palivizumab); 100mg single dose vial *)
* *
*
MEDIMMUNE RESERVES THE RIGHT TO LIMIT ORDER QUANTITIES.
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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ADDENDUM III
STORAGE AND SHIPMENT OF SYNAGIS(R)
- UPON RECEIPT AND UNTIL RECONSTITUTION FOR USE, SYNAGIS(R) SHOULD BE
STORED BETWEEN 2(Degree)-8(degree) C(35.6(DEGREE)-46.4(DEGREE)F). DO
NOT FREEZE.
- SHIPPING INFORMATION.
---------------------- -------------------------------- -------------------------------------
Order Quantity November 1-March 31(1) (Winter) April-October 31(1) (Summer)
---------------------- -------------------------------- -------------------------------------
2-20 vials 2" EPS container 2" EPS container
2 x 24 oz refrigerated Polar 4 x 24 oz refrigerated Polar paks
paks 1 x 24 oz frozen Polar pak drawing
---------------------- -------------------------------- -------------------------------------
21-144 vials 3" EPS container 3" EPS container
8 x 24 oz refrigerated Polar 8 x 24 oz refrigerated Polar paks
paks 4 x 24 oz frozen Polar pak drawing
---------------------- -------------------------------- -------------------------------------
- BUBBLE WRAP ALL INDIVIDUAL VIALS.
- FILL EMPTY SPACES INSIDE CARTON WITH PACKING PAPER.
- PLACE "REFRIGERATE UPON ARRIVAL 2-8(DEGREE)C" STICKER ON OUTSIDE OF
carton.
- ALL PRODUCT SHOULD BE SHIPPED 2ND DAY AIR AM DELIVERY. IF THIS SERVICE
IS UNAVAILABLE SHIP THE PACKAGE NEXT DAY AIR.
--------------------------
(1) Summer and Winter dates were chosen based on average temperatures around the
country.
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ADDENDUM IV
DISTRIBUTOR PERFORMANCE REQUIREMENTS
- DISTRIBUTOR WILL SUBMIT * TO MEDIMMUNE *. DATA MUST BE SUBMITTED AS *
ACCORDING TO THE FORMAT LISTED *.
- DISTRIBUTOR WILL * OF USE *.
- DISTRIBUTOR WILL * FOR *.
- DISTRIBUTOR * WHOLESALER ACQUISITION COST.
- DISTRIBUTOR WILL PROVIDE MEDIMMUNE WITH * FOR PURPOSES OF MARKET
RESEARCH AND MAILINGS ONLY. INFORMATION WILL BE AGREED UPON BY BOTH
PARTIES AND WILL REMAIN CONFIDENTIAL. HOWEVER, DISTRIBUTOR SHALL NOT
BE REQUIRED TO PROVIDE * PERTAINING * FOR WHICH DISTRIBUTOR HAS A *.
- DISTRIBUTOR WILL * DISTRIBUTOR *, NOTIFYING DISTRIBUTOR *.
- DISTRIBUTOR WILL PROVIDE SUPPORT, WHERE APPROPRIATE, TO MEDIMMUNE *.
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
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ADDENDUM V
DISTRIBUTOR * REQUIREMENTS
- DISTRIBUTOR * TO * WITH RESPECT TO *.
- DISTRIBUTOR WILL ATTEMPT TO *, AND TO * PRODUCT TO * THEREUNDER.
- IN THE EVENT DISTRIBUTOR IS UNABLE TO *, DISTRIBUTOR WILL SEND * PRIOR
TO ANY *.
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities and Exchange Act of 1934 and has
been filed separately with the Securities and Exchange Commission.
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EXHIBIT A
AFFILIATES
Accredo Health, Incorporated
Texas Health Pharmaceutical Resources
Teddy Bear Home Care/Drug Therapies d/b/a Xxxx Childrens Home Health/Drug
Therapies
CM Factorcare
LeBonheur Childrens Medical Center, Inc.
Childrens Home Services
DuPont Hospital for Children
Childrens National Medical Center
Exhibit A may be amended from time to time *.
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EXCEL SPREADSHEET
EXHIBIT B
*
*Omitted information is the subject of a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934 and has been
filed separately with the Securities and Exchange Commission.
