EXHIBIT 10.25
000 XXXXX XXXX TEL: + 0 000 000 0000
XXXXXX, XX X0X 0X0 FAX: + 0 000 000 0000
CANADA xxx.xxx.xxxxxxx.xxx
(MDS NORDION LOGO)
April 27, 2006
Molecular Insight Pharmaceuticals, Inc.
000 Xxxxxx Xxxxxx
Xxxxxxxxx, Xxxxxxxxxxxxx
000000 XXX
Dear Sirs:
Re: AMENDMENT #2 to the Agreement between NDS Nordion, a division of MDS
(Canada) Inc. ("Nordion") and Molecular Insight Pharmaceuticals, Inc.
("Molecular Insight") dated June 14, 2004 (the "Development Agreement"),
and AMENDMENT #1 to the Agreement between Nordion and Molecular Insight
Dated January 12, 2006 (the "BMIPP Supply Agreement")
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Reference is made to the Development Agreement and BMIPP Supply Agreement,
respectively dated the 14th day of June, 2004 and the 12th day of January, 2006.
In consideration of $1.00 and other valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties agree as follows:
DEVELOPMENT AGREEMENT
1. The Development Agreement shall be amended by deleting Section 4.1 and
adding the following Section 4.1 in its stead:
"4.1 Post validation, the Batch size available for Clinical Trial
supply, shall be of a one (1) Ci and two (2) Ci Batch size. The
maximum number of doses available for shipment from a one (1) Ci
Batch will be ** doses and the maximum number of doses available for
shipment from a two (2) Ci Batch will be ** doses. The remaining
BMIPP doses will be retained by Nordion for archival and quality
assurance testing purposes. BMIPP will be shipped in an appropriate
lead shield, which will be provided at Nordion's expense. All
necessary labels for shipment will be provided by Molecular Insight
Pharmaceuticals and shall meet all applicable regulatory
requirements."
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2. Schedule A, Item 6, of the Development Agreement "Scope of Work" shall be
amended such that paragraph b) shall read as follows and paragraphs c) and
d) shall be added:
"b) Compile all data for validation files for 1 Ci Validation Runs
c) Perform three runs with 2 Ci of 1-123.
d) Compile all data for validation files for 2 Ci Validation Runs."
3. Schedule F, Paragraph 2, (entitled "Milestone Payments") Milestone 6 of the
Development Agreement, shall be amended and read as follows:
"Milestone 6 GMP Validation Runs **"
4. Schedule F, Paragraph 3, (entitled "Batches for Phase III Clinical Supply")
of the Development Agreement, shall be amended and in its entirety shall
read as follows:
"Price: ** per 1 Ci Batch
** per 2 Ci Batch
Notes to Schedule F:
a) 1 Ci Batch runs are approximately ** doses of BMIPP of which 20
are shippable.
b) 2 Ci Batch runs are approximately ** doses of BMIPP of which 40
are shippable.
c) Payment is due within 30 days of the date appearing on Nordion's
invoice."
BMIPP SUPPLY AGREEMENT
1. The preamble, paragraph IV of the BMIPP Supply Agreement shall be amended
such that the date referenced therein shall be "the 14th day of June,
2004".
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2. Schedule D of the BMIPP Supply Agreement shall be amended and in its
entirety shall read as follows:
"SCHEDULE D
PRICES OF BATCHES FOR CLINICAL TRIAL SUPPLY
A. 1 CI BATCH OF BMIPP
Price: Year 1 supply of BMIPP under this Agreement US is ** per Batch
Year 2 supply: **
Year 3 supply: **
Year 4 supply: **
Year 5 supply: **
B. 2 CI BATCH OF BMIPP
Price: Year 1 supply of BMIPP under this Agreement is US ** per Batch
Year 2 supply: **
Year 3 supply: **
Year 4 supply: **
Year 5 supply: **
Notes to Schedule D:
1. 1 Ci Batch is approximately ** doses of BMIPP (as defined in Schedule B)
of which ** are shippable and 10 are retained by Nordion for archival
and quality assurance testing purposes only.
2. 2 Ci Batch is approximately ** doses of BMIPP (as defined in Schedule B)
of which ** are shippable and the remaining doses are retained by
Nordion for archival and quality assurance purposes only.
3. The All Items Canadian Consumer Price Index ("CPI") will be based on
the percentage increase in the CPI for the twelve (12) month period
ending three (3) months prior to such anniversary as published in the
Canadian Government annual reports."
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All other terms and conditions in the aforementioned agreements shall remain in
full force and effect. The foregoing amendments shall be effective as of the
date first written above.
If you agree with the foregoing, please execute this agreement in the space
provided below.
MDS Nordion, a division of MDS (Canada) Inc.
By: /s/ Xxxxx Xxxxxx
AGREED this 9th day of May, 2006.
Molecular Insight Pharmaceuticals, Inc.
By: /s/ Xxxx X. XxXxxx
