Exhibit 10.129
Amendment No. 3
To Distribution And Marketing Collaboration Agreement
This Amendment No. 3 to the Ethyol(R)(amifostine) Distribution and Marketing Collaboration Agreement ("Amendment No. 3") is entered
into as of the 4th day of September, 2001 between MedImmune Oncology, Inc. successor in interest to U.S. Bioscience, Inc.
("MedImmune") and ALZA Corporation ("ALZA").
RECITALS
A. MedImmune and ALZA entered into a Distribution and Marketing Collaboration Agreement (as amended prior to the date
hereof, the "Agreement") on the 12th day of December, 1995.
B. The parties wish to further amend the Agreement as set forth herein.
NOW THEREFORE, the parties agree as follows:
1. Terms. Capitalized terms used in this Amendment No. 3 shall have the same meanings as in the Agreement, unless
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otherwise defined herein.
2. Termination of EXTENSION PERIOD.
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(a) The EXTENSION PERIOD shall end on September 30, 2001. Thereafter, MedImmune will be solely responsible
for development and commercialization of the PRODUCT, including all marketing, sales, distribution, regulatory, clinical and medical
affairs activities.
(b) Prior to October 1, 2001, MedImmune shall be entitled to purchase from ALZA, subject to the limitations
of ALZA's then existing inventory and ALZA's need to supply customers through September 30, 2001, at least (CONFIDENTIAL TREATMENT
REQUESTED) vials of PRODUCT to amass the inventory necessary for MedImmune to begin selling PRODUCT on October 1, 2001.
(c) MedImmune shall purchase from ALZA all of ALZA's inventory of PRODUCT which is in saleable condition and
has (CONFIDENTIAL TREATMENT REQUESTED) as of September 30, 2001 and PRODUCT that MedImmune previously obtained under Paragraph 2(b)
with (CONFIDENTIAL TREATMENT REQUESTED) upon the date of purchase at the price at which ALZA purchased the PRODUCT from MedImmune
exclusive of shipping, insurance, taxes and other costs incurred by ALZA to originally purchase such PRODUCT. MedImmune shall also
purchase from ALZA (CONFIDENTIAL TREATMENT REQUESTED) vials of PRODUCT (CONFIDENTIAL TREATMENT REQUESTED) at which ALZA purchased
the PRODUCT from MedImmune exclusive of shipping, insurance, taxes and other costs incurred by ALZA to originally purchase such
PRODUCT. Dated Product may be purchased pursuant to MedImmune's inventory buildup as detailed in Paragraph 2(b) and/or from ALZA's
inventory remaining on or after September 31, 2001. In no event or manner, shall MedImmune be required to purchase PRODUCT that has
(CONFIDENTIAL TREATMENT REQUESTED).
MedImmune shall be responsible for all shipping, insurance, taxes and related costs associated with the
transactions contemplated by Sections 2(b) and (c). MedImmune shall pay ALZA for such inventory on or before October 15, 2001.
(d) In consideration for the early termination of the EXTENSION PERIOD as set forth in this Amendment No. 3,
MedImmune shall pay to ALZA the following amounts, subject to the adjustments outlined below:
(i) $6.72 million on or before December 31, 2001; and
(ii) $6.72 million on or before May 15, 2002.
During the period from October 1, 2001 to March 31, 2002, if MedImmune's Net Sales of the PRODUCT are either:
(1) (CONFIDENTIAL TREATMENT REQUESTED)
Or
(2) (CONFIDENTIAL TREATMENT REQUESTED).
In no event, however, shall the total of the two payments from MedImmune to ALZA be less than $6.72 million.
(e) At its expense, ALZA (or its Affiliate) shall use reasonable commercial efforts to make the PRODUCT
available for sale throughout the TERRITORY until September 30, 2001. MedImmune, at its expense, shall use reasonable commercial
efforts to make the PRODUCT available for sale throughout the TERRITORY during the period of October 1, 2001 through March 31, 2002.
3. Reverse Payment Obligation Amendment. Notwithstanding any other provision of this Agreement, MedImmune's reverse
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payment obligations contemplated by Section 3.6(d)(iii) of the Agreement shall not commence until April 1, 2002 and will be in
effect through March 31, 2011; sales of the PRODUCT by MedImmune during the period of October 1, 2001 to March 31, 2002 shall not be
subject to such reverse payment obligations.
4. Normal Course of Business Covenant. Each party agrees that it will not engage in activities outside the normal
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course of business that are intended to artificially inflate or deplete inventory levels or encourage or discourage the occurrence
of Net Sales for the purpose of affecting payments due to the other party under the Agreement from the date of this Amendment No. 3
through March 31, 2002. Specifically, ALZA shall not at anytime after the execution date of this Amendment No. 3 and MedImmune shall
not during the period October 1, 2001 to March 31, 2002 outside the normal course of business, modify (i) the price of the PRODUCT;
(ii) current discounts to customers for timely payment for purchases of the PRODUCT; or (iii) initiate promotional discount programs
for the PRODUCT for which such party had not undertaken substantial preparations before the execution of this Amendment No. 3.
5. Trade Returns; Reimbursements.
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(a) ALZA shall bear all costs and expenses related to all returns, charge backs, and administrative fees
received prior to (CONFIDENTIAL TREATMENT REQUESTED). MedImmune shall bear all costs and expenses related to all returns, charge
backs and administrative fees received on or after (CONFIDENTIAL TREATMENT REQUESTED).
(b) ALZA shall bear all costs and expenses related to reimbursements and rebates for all federal and state
healthcare related agencies, including but not limited to Medicaid, and any state assistance programs, including PACE
("Reimbursement(s)") for the PRODUCT requested (CONFIDENTIAL TREATMENT REQUESTED). MedImmune shall bear all costs and expenses
related to Reimbursements for the PRODUCT requested (CONFIDENTIAL TREATMENT REQUESTED). If ALZA receives any requests for payment of
Reimbursements dated after March 31, 2002, it shall make payment on such requests and thereafter shall request reimbursement from
MedImmune, which MedImmune shall promptly pay. If MedImmune receives any requests for payment of Reimbursements dated on or before
March 31, 2002, MedImmune shall pay such requests and deduct the total amount paid from the payment that will be made to ALZA by May
15, 2001 according to Paragraph 2(d)(ii). If, after March 31, 2002, MedImmune receives requests (from ALZA or third parties) for
payment of Reimbursements for PRODUCT dispensed to patients before October 1, 2001 which requests for Reimbursement in the aggregate
exceed (CONFIDENTIAL TREATMENT REQUESTED), MedImmune shall be entitled to invoice ALZA for the amount in excess of (CONFIDENTIAL
TREATMENT REQUESTED) and ALZA shall promptly pay such invoices.
6. Customer Lists; Notification of Customers.
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(a) Within three (3) business days of ALZA's receipt of this fully executed Amendment No. 3or as soon
thereafter as is practicable, ALZA will provide MedImmune with a customer list ("Customer List") that (i) identifies all wholesalers
and distributors that have bought the PRODUCT from ALZA in the previous three (3) years; (ii) provides the monthly amounts
(CONFIDENTIAL TREATMENT REQUESTED) during the same period; (iii) (CONFIDENTIAL TREATMENT REQUESTED) of the PRODUCT that have been
outstanding for (CONFIDENTIAL TREATMENT REQUESTED); (iv) provides the (CONFIDENTIAL TREATMENT REQUESTED) in units and dollars; (v)
(CONFIDENTIAL TREATMENT REQUESTED) for any purchase of the PRODUCT; and (vi) provides the (CONFIDENTIAL TREATMENT REQUESTED) for the
previous three (3) years.
(b) By no later than October 15, 2001, ALZA shall provide to MedImmune an updated Customer List.
(c) Within three (3) business days of ALZA's receipt of this fully executed Amendment No. 3, ALZA shall
provide a list of (CONFIDENTIAL TREATMENT REQUESTED) and hospitals to which it details the PRODUCT and their addresses and telephone
and fax numbers if available.
(d) Upon MedImmune's request, ALZA shall forward notification to its customers that MedImmune has assumed
responsibility for the marketing and sale of the PRODUCT in the TERRITORY. Prior to ALZA forwarding notification, the parties shall
agree upon the content of such notice.
7. Existing Contracts for the Sale of PRODUCT.
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(a) MedImmune acknowledges that ALZA has entered into contracts for the sale of PRODUCT at a discount to
ALZA's wholesale acquisition cost for the PRODUCT, and for the payment of administrative fees based on sales of PRODUCT by certain
customers.
(b) Within three (3) business days of ALZA's receipt of this fully executed Amendment No. 3, ALZA shall
provide MedImmune with true and complete copies of all the contracts with its customers regarding the PRODUCT that are currently in
effect ("Commercial Contracts") to the extent that it is legally and contractually able to do so. In the event that ALZA is not
legally or contractually permitted to provide copies of certain Commercial Contracts to MedImmune, it shall seek to obtain
permission from the other party to each such Commercial Contract to disclose a true and complete copy of the contract to MedImmune.
In its efforts to obtain such permission, ALZA shall be permitted to confidentially disclose to such other parties that marketing of
the PRODUCT may be transferred and in doing so may, identify MedImmune as the potential transferee, but shall not disclose the date
of such transfer.
(c) Upon approval by MedImmune, ALZA shall assign each Commercial Contract to MedImmune to the extent that it
is assignable. Upon the request of MedImmune, ALZA agrees to use commercially reasonable efforts to secure from the entities with
which it has entered into non-assignable Commercial Contracts permission to assign such Commercial Contracts to MedImmune or to
assign the rights and obligations of the parties in so far as they relate to the PRODUCT, effective October 1, 2001.
8. Patient Support Programs.
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(a) MedImmune acknowledges that ALZA has created two programs designed to assist medically needy patients,
namely ALZA's "Oncology Connection Program" ("OCP") and ALZA's "Indigent Patient Program" ("IPP"). MedImmune shall not have any
obligation to continue the OCP and IPP programs, but will adopt programs similar in intent to such programs by October 1, 2001 as
set forth below. The parties agree, nevertheless, to cooperate in the exchange of information (but not documents) necessary to
effectuate an orderly transition to, and assessment of, the OCP and IPP by MedImmune.
(b) The OCP provides assistance and advocacy for patients who experience difficulty obtaining insurance
coverage for the PRODUCT. The parties agree that ALZA shall continue to offer the OCP to patients prescribed the PRODUCT or their
physicians until September 30, 2001. By October 1, 2001, MedImmune shall implement a program that is similar in intent to the OCP.
(c) Under the IPP, patients who meet pre-determined financial obligations and do not have or are ineligible
for third party insurance receive PRODUCT from ALZA free of charge. The parties agree that ALZA shall continue to offer the IPP to
patients prescribed the PRODUCT until September 30, 2001. By October 1, 2001, MedImmune shall implement a program that is similar in
intent to the IPP.
(d) Within three (3) business days of ALZA's receipt of this fully executed Amendment No. 3, ALZA shall
disclose (i) (CONFIDENTIAL TREATMENT REQUESTED) (ii) (CONFIDENTIAL TREATMENT REQUESTED); and (iii) the monthly amount in units of
PRODUCT provided under the IPP for the previous two (2) years.
(e) ALZA makes no representations or warranties concerning the OCP or IPP and MedImmune's decision to
continue or modify the programs shall be based on its independent assessments of the programs and ALZA shall not be liable for any
damages or claims made against MedImmune concerning such programs after September 30, 2001, except to the extent that such claims
are based on ALZA's conduct prior to September 30, 2001.
9. Investigator Sponsored Studies. The parties acknowledge that ALZA has agreed to provide funds and/or PRODUCT to
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support independent Investigator Sponsored Studies ("ISS") of the PRODUCT. ALZA has used commercially reasonable efforts to identify
all such studies, which are identified on a list attached hereto as Exhibit A. Upon MedImmune's request, ALZA shall provide true and
complete copies of the ISS agreements, including the exhibits to the agreements and amendments, that cover the studies listed on
Exhibit A. On or before September 10, 2001, MedImmune shall review the list and identify those studies it wishes to continue, and
upon request and approval by MedImmune, ALZA shall assign the agreements pertaining to those ISS' to MedImmune. The ISS agreements
that MedImmune does not request to have assigned to it will be terminated by ALZA. MedImmune specifically agrees that it will accept
assignment of the ISS agreement between ALZA and PRN dated January 19, 1999 (the "PRN Agreement") concerning the investigation of
PRODUCT in the treatment of Stage III A, III B, Non-Small Cell Lung Cancer (NSCLC) (the "PRN Study"), and the ISS agreement between
ALZA and the American College of Radiology, Radiation Therapy Oncology Group, dated July 25, 1998 (the "RTOG Agreement"), also
concerning the investigation of PRODUCT in NSCLC (the "RTOG Study"). ALZA shall be responsible for paying and fulfilling all costs
and obligations of the PRN Agreement that result from conducting the PRN Study on or before September 30, 2001, including those
associated with patient recruitment. MedImmune shall be responsible for paying all costs and obligations of the PRN Agreement that
result from conducting the PRN Study on or after October 1, 2001. MedImmune shall also be responsible for paying and fulfilling all
costs and obligations of the RTOG Agreement that result from conducting the RTOG Study on or after the date of this Amendment No. 3
and (notwithstanding the provisions of the letter agreement between ALZA and U.S. Bioscience dated July 25, 1998) shall be
responsible for paying the milestone for (CONFIDENTIAL TREATMENT REQUESTED) in the RTOG study set forth in Section I(c) of Exhibit B
of the RTOG Agreement ("Milestone (c)"), regardless of whether the obligation to pay Milestone (c) accrues before or after the date
of this Amendment No. 3. If MedImmune terminates the PRN Study prior to March 31, 2002, it will pay ALZA (CONFIDENTIAL TREATMENT
REQUESTED). If MedImmune terminates the RTOG Study prior to March 31, 2002, it will pay ALZA (CONFIDENTIAL TREATMENT REQUESTED),
reduced by any amount that MedImmune has paid to RTOG for Milestone (c).
10. Use and Licenses of Promotional Materials; Trademark Assignments. The parties agree that all promotional
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materials used in the marketing of the PRODUCT shall continue to bear ALZA's name and logo until September 30, 2001. The parties
further agree that after September 30, 2001, MedImmune may continue to use all promotional materials bearing ALZA's name and logo
until the supply of such materials is depleted. However, all new marketing materials that are printed after the effective date of
this Amendment No. 3 shall bear only MedImmune's name and or logo. Except as specifically provided in this Amendment No. 3, no
rights or licenses with respect to ALZA's name or logo is granted, nor shall such be deemed to be granted, by this provision.
11. Medical Inquiries. The parties agree that ALZA's obligations regarding correspondence with physicians and
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processing customer complaints pursuant to the provisions of Sections 4.6 and 4.7 of the Agreement shall cease on August 22, 2001.
Further, recognizing that promotional materials bearing ALZA's address and telephone number will be available to physicians and
customers after August 22, 2001, the parties agree that on or before August 17, 2001, MedImmune shall provide ALZA with a forwarding
address for correspondence concerning the PRODUCT, and a telephone number to provide to callers requesting information regarding the
PRODUCT. ALZA shall have no obligation with regard to such correspondence other than to forward mail and redirect phone calls
requesting information regarding the PRODUCT within twenty four (24) hours of receipt as specified by MedImmune pursuant to this
Section 11. Further, the parties agree that during the period August 22, 2001, through September 30, 2001, MedImmune shall perform
all medical communications tasks related to the PRODUCT and that ALZA shall pay MedImmune (CONFIDENTIAL TREATMENT REQUESTED) to
perform such tasks, such amount to be deducted from the inventory payment to be made from MedImmune to ALZA under Section 2(c) of
this Amendment No.3.
12. Training. The parties agree that ALZA's obligations regarding training of the ALZA and MedImmune sales forces
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pursuant to the provisions of Sections 4.9 of the Agreement shall cease upon execution of this Amendment No. 3.
13. PRODUCT Recalls, etc. Effective October 1, 2001, Section 9.5 of the Agreement is deleted in its entirety and
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replaced with the following: If, on or before October 1, 2001, (i) any governmental agency or authority issues a request or
directive, or orders that PRODUCT be recalled or retrieved; (ii) a court orders that PRODUCT be recalled or retrieved; or (iii)
MedImmune determines that PRODUCT should be recalled, retrieved or that a "dear doctor" letter is required relating to the PRODUCT,
MedImmune shall conduct such activities. ALZA agrees to cooperate with MedImmune to the extent reasonably necessary to effect such
action. In the event and to the extent such activities must be undertaken due to negligence or willful misconduct of ALZA, it shall
reimburse MedImmune for the costs incurred by MedImmune to perform such activities. In all other cases, MedImmune shall be solely
responsible for the costs of such activities.
14. Nondisclosure. The month and date upon which MedImmune shall assume responsibility for marketing the PRODUCT in
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the TERRITORY shall not be disclosed publicly or to any third parties by ALZA unless under the conditions stated in a prior written
authorization obtained from MedImmune. The foregoing notwithstanding, the parties agree that MedImmune will issue a press release on
or before October 1, 2001 concerning this Amendment No. 3 and that ALZA shall have a right to review and comment upon such press
release, and that MedImmune shall not unreasonably refuse to incorporate ALZA comments. If a press release is not issued on or
before October 1, 2001 then ALZA shall be entitled to disclose that it has transferred responsibility for marketing the PRODUCT to
MedImmune.
15. Cooperation. The parties agree that they shall cooperate with one another to the extent reasonably necessary to
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ensure a smooth transition of responsibilities under the Agreement.
16. No Other Changes. Except as specifically set forth above, the Agreement remains in full force and effect,
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without modification.
IN WITNESS WHEREOF, the parties have executed this Amendment No. 3 as of the 4th day of September, 2001.
ALZA Corporation MedImmune, Inc.
By /s/: Xxxx Xxxxxx By /s/: Xxxxx X. Xxxx
Title: Vice President, Business Title: Vice Chairman and Chief
Development Executive Officer
