Exhibit
10.49
Execution
Version
SUPPLY & DISTRIBUTION AGREEMENT
Between
IMMTECH PHARMACEUTICALS, INC.
AND
PAR PHARMACEUTICAL, INC.
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Table of Contents
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| ARTICLE
I - DEFINITIONS |
3
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| ARTICLE
II – EFFECTIVE DATE ; CONTROLLING
TERMS |
5
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| ARTICLE
III – COMMERCIAL SUPPLY |
5
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| ARTICLE
IV – PRODUCT QUALITY AND REGULATORY MATTERS |
7
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| ARTICLE
V - REPRESENTATIONS, WARRANTIES AND COVENANTS |
10
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SUPPLY AGREEMENT
This
Supply Agreement (this “Supply Agreement”) is made
and entered into as of June 11, 2007 (the
“Effective Date”), by and between Immtech
Pharmaceuticals, Inc., a Delaware corporation with its
principal place of business at 150 Fairway Drive, Vernon
Hills, IL 60061 (“Immtech”), and Par
Pharmaceutical, Inc., a Delaware corporation having a
principal place of business at 300 Tice Boulevard,
Woodcliff Lake, New Jersey 07677
(“Par”). Immtech and Par may be
referred to herein individually as a “Party”, or
collectively as the “Parties”. All
capitalized terms used in this Supply Agreement shall have the
meaning ascribed to them in the Licensing Agreement (as
defined below) to which this Supply Agreement is an
Exhibit.
Recitals
Whereas,
Immtech and Par have entered into a Licensing Agreement, dated
as of the date hereof (the “Licensing
Agreement”);
Whereas,
Immtech has expertise manufacturing pharmaceutical products
for infectious diseases; and
Whereas,
Par desires to purchase from Immtech, and Immtech desires to
manufacture and sell to Par, the Product all on the terms and
conditions set forth herein.
Now, Therefore, in
consideration of the foregoing and the covenants and promises
contained herein, the Parties hereby agree as
follows:
ARTICLE I - DEFINITIONS
Section 1
Definitions .
For purposes of this Agreement, the following terms shall have the
meanings set forth below:
1.1
“Administrative Costs” means all costs related to
conducting a recall in accordance with Applicable
Laws.
1.2
“Applicable Laws” means all laws, ordinances,
rules and regulations within the Territory applicable to the
Manufacturing and Packaging of the Product or any aspect
thereof and the obligations of Immtech or Par, as the context
requires under this Agreement, including, without limitation,
(i) all applicable federal, state and local laws and
regulations of each Territory; (ii) the U.S. Federal Food,
Drug and Cosmetic Act, and (iii) the cGMPs.
1.3 “Batch”
means defined quantity of finished drug product which has been
Manufactured and Packaged in accordance with the
Specifications.
1.4 “Calendar
Quarter” means a period of three (3) consecutive months
commencing on January 1, April 1, July 1 or October 1 of any
calendar year.
1.5 “COA”
means Certificate of Analysis.
1.6 “Commencement
Date” means the first date upon which FDA approves
pafuramidine maleate for the treatment of PCP.
1.7 “Contract
Year” means each consecutive twelve (12) month period
beginning on the Commencement Date.
1.8 “Defective
Product” means Product that is not
releasable.
1.9 “Delivery
Date” means the date on which Immtech shall tender the
relevant Batch(es) to Par. Each Delivery Date shall be
specified by Par on the relevant Purchase Order and confirmed
by Immtech as set forth in Section 3.4.
1.10 “Firm
Commitment” means a binding commitment in writing made
by Par to purchase Product in accordance with Section
3.1.
1.11 “Manufacture”
means all operations of receipt of materials, production,
packaging, labeling, quality control, release of drug
product.
1.12 “Manufacture
Date” means the date that pafuramidine first comes into
contact with another ingredient during the manufacturing
process of drug product.
1.13 “Manufacturing
Release Record(s)” means a) all completed
production/Batch records; b) all quality control test/request
forms (result worksheets) and associated data; c) dynamic
monitoring performed during processing; d) any alert/action
notifications generated during processing; e) any planned or
unplanned deviations associated with the Product; f) any out
of Specification result investigations associated with the
Product; g) the Certificate of Analysis for the Batch
comparing testing to Specifications; and h) the appropriate
disposition notification for the Batch.
1.14 “Nonconformity”
means a deficiency in characteristic, documentation or
procedure, which renders the quality of the Product non
acceptable or not in accordance with specified
requirements.
1.15 “Packaging”
means Primary Packaging and Secondary Packaging.
1.16 “Primary
Packag(ing)” means material intended to contain and
protect drug product during handling, storage and
transport.
1.17 “Purchase
Order” shall have the meaning set forth in Section
3.2.
1.18
“Rolling Forecast” shall have the meaning set
forth in Section 3.1.
1.19 “Secondary
Packag(ing)” means packaging material that does not come
into contact with drug product.
1.20 “Specification”
means the specifications for the Product attached hereto as
Exhibit A in draft form until the Commencement Date and made a
part of hereof, as determined
in accordance with the analytical methodology set forth
therein, as such specifications may be amended from time to
time.
1.21 “Unit”
means each individually Packaged unit of
Product.
ARTICLE II – EFFECTIVE DATE; CONTROLLING
TERMS
Section
2.1 Effective Date
This
Agreement shall automatically become effective as of the
Execution Date of the Licensing Agreement.
Section
2.2 Controlling Terms
This
Agreement is governed by the terms of the Licensing Agreement
and all of such terms apply to and control this Supply
Agreement. For any terms that may be interpreted to
conflict between the two agreements, the terms of the
Licensing Agreement shall control.
ARTICLE III – COMMERCIAL SUPPLY
Section
3.1
Forecasts
On
or before the fifteenth (15th) day of each calendar month
following the Commencement Date and at least four months prior
to the first Delivery Date, Par shall furnish to Immtech a
written twelve (12) month rolling forecast of the quantities
of Product that Par intends to order from Immtech during such
period (“Rolling Forecast”). The first 3 months of
such Rolling Forecast shall constitute a binding commitment
for the quantities of Product specified therein (“Firm
Commitment”) and the following 9 months of the Rolling
Forecast shall be non-binding, good faith
estimates.
Section
3.2
Purchase Orders
At
least quarterly, Par shall submit purchase orders for the Firm
Commitment portion of the Rolling Forecast, which specify the
actual number of Units to be Manufactured and Packaged, and
the requested Delivery Dates for each Batch (“Purchase
Order”). Product shall be ordered by Par only
in writing. Immtech will not accept verbal orders of any
kind for the production of Product. Par shall submit each
Purchase Order to Immtech at least ninety (90) days in advance
of the earliest Delivery Date requested in the Purchase
Order. Immtech will confirm such Delivery Dates
within fifteen (15) business days of receipt of the Purchase
Order and will use commercially best efforts to ensure
the
Product
is delivered by the Delivery Dates specified in the Purchase
Orders. [****]. In the event of a conflict between
the terms of any Purchase Order and this Agreement, this
Agreement shall control. Notwithstanding the foregoing, during
any calendar quarter, Immtech shall be required to supply Par
with quantities of Product up to one hundred twenty-five
percent (125%) of the forecasts submitted by Par in respect of
such period; provided , however , that if Par
submits Purchase Orders that exceed one hundred twenty-five
percent (125%) of the forecasts submitted by Par in respect of
such period, then Immtech shall use commercially reasonable
efforts to supply Par with such excess quantities of the
Product.
Section
3.3
Product Supply
All
Product supplied hereunder shall be manufactured by Immtech in
accordance with the Specifications and cGMPs as determined
using the manufacturing process described in Immtech’s
NDA for the Product. Immtech will utilize a
documented system of procedures for the control of changes to
the Specifications. Any significant changes shall
be reviewed and approved by both Parties prior to
implementation. Immtech will be responsible for
labeling and packaging of product for final distribution,
utilizing trademarks and artwork provided by Par to Immtech in
accordance with the Licensing Agreement.
Section
3.4
Product Delivery
All Purchase Orders will
contain the following information: (i) the precise quantity
of Product desired and required Delivery Dates, (ii) desired
packaging and quantities by package (e.g., bottles of 28,
bottles of 500, sample blisters of 14), (iii) the anticipated
shipping destination for Product and (iv) such other
information as Par wishes to provide or that Immtech might
find necessary or useful in completing a specific work
order. Product shall be delivered F.O.B. North
American shipping destination (with the specific destination
to be determined by Par), freight prepaid by Immtech, no
earlier than fourteen (14) days prior to the requested
Delivery Date, and no later than the Delivery Date. Each
shipment of the Product shall be accompanied by relevant COAs
and an invoice. Par will then own such
inventories. Par will assume all operational and
financial responsibility for processing and handling returned
inventories due to product expiry.
Section
3.5 Payment
For the quantities to be
supplied by Immtech, Par shall pay Immtech the T
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