SUPPLY & DISTRIBUTION AGREEMENT Between IMMTECH PHARMACEUTICALS, INC. AND PAR PHARMACEUTICAL, INC.
Exhibit
10.49
Execution
Version
SUPPLY
& DISTRIBUTION AGREEMENT
Between
AND
PAR
PHARMACEUTICAL, INC.
|
Table
of Contents
|
|
| ARTICLE I - DEFINITIONS |
3
|
| ARTICLE II – EFFECTIVE DATE ; CONTROLLING TERMS |
5
|
| ARTICLE III – COMMERCIAL SUPPLY |
5
|
| ARTICLE IV – PRODUCT QUALITY AND REGULATORY MATTERS |
7
|
| ARTICLE V - REPRESENTATIONS, WARRANTIES AND COVENANTS |
10
|
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 ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇ (“Immtech”), and Par
Pharmaceutical, Inc., a Delaware corporation having a principal place of
business at ▇▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇
(“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 ▇▇, ▇▇▇▇▇▇▇ ▇▇ ▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇ ▇▇), (▇▇▇) 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 Transfer Price. Par shall use
commercially reasonable efforts to pay for Product delivered within thirty
(30)
days of the date of invoice or receipt of the Product, whichever shall last
occur, and in no event later than forty-five (45) days from such later date;
provided, however, that Par shall not be obligated to pay for any
shipment of Product disputed under Section 4.4 during the pendency of such
dispute.
****
Material omitted pursuant to a request for confidential treatment under Rule
24b-2 of the Exchange Act of 1934. Material filed separately with the
Securities and Exchange Commission.
ARTICLE
IV – PRODUCT QUALITY AND REGULATORY MATTERS
Section
4.1 Specification(s) of Product
Product
will be Packaged, labeled and handled by Immtech in accordance with the
Specifications.
Section
4.2 Unmodified Product
Immtech
agrees to inform Par of any changes to the Specifications that may impact final
product release and Immtech agrees to continue to supply unmodified Product
to
Par as ordered under the terms of and subject to the conditions and limitations
of this Agreement for a minimum of two (2) years.
Section
4.3(a) Product Quality
Immtech
covenants that the Product shall be manufactured, Packaged, tested, stored
and
handled in accordance with the Specifications, the Act and all relevant FDA
regulations, guidelines and guidances, including cGMPs.
Immtech
warrants that neither it, nor its vendors, will engage in any act which causes
any Product produced for Par to become adulterated, and agrees that such Product
will not be adulterated, within the meaning of the federal Food, Drug and
Cosmetic Act, as amended, when Product is delivered to Par.
Section 4.3(b) Quality Control
Immtech
will take all steps reasonably necessary to ensure that it has contracted with
Third Party manufacturers with the facilities, equipment, instrumentation,
resources and trained personnel to provide all raw materials, in-process and
product assays, analysis and other testing, as compliance with cGMP may require
in connection with Immtech’s supply of Product. Immtech shall provide
a COA for each lot of Product supplied hereunder at the time of
shipment.
Immtech
shall maintain complete and accurate documentation of all validation data,
stability testing data, batch records, quality control and laboratory testing
and any other data required under cGMP in connection with the supply of Product
hereunder.
Section
4.4 Defective Product
Within
at
most thirty (30) days of delivery of Batches of the Product, Par shall notify
Immtech of any Nonconformity of the delivered batches with the Specifications.
Any Product received by Par from Immtech that has not been rejected by Par
within thirty (30) days after receipt shall be deemed to have been accepted;
provided, however, that other than with respect to defects or
other non-compliance plainly observable from a visual inspection, any acceptance
or deemed acceptance shall not adversely affect or otherwise diminish Par’s
rights to receive shipments of the Product in compliance with the requirements
of Section 4,1, 4.3(a), 4.3(b) or 5.1. In the event of any
Nonconformity
of the delivered batches of the Product, (i) Immtech shall deliver to Par
replacement Batches of Product conforming to the Specifications within thirty
(30) days of receipt of such Nonconformity notice from Par and (ii) Par shall
destroy the delivered batches, the costs of which shall be borne by
Immtech.
In
the
event of a disagreement between the Parties as to whether the Product meets
the
Specifications, the Parties shall cause a mutually acceptable independent
laboratory to review records, test data and to perform the tests and/or analyses
set forth in the Specifications on samples of the alleged Defective
Product. The independent laboratory’s results shall be final and
binding. Unless otherwise agreed to by the Parties in writing, the
costs associated with such testing and review shall be borne by the Party which
was incorrect about whether the Product meets the Specifications.
Section
4.5 Facility
Access
Upon
written request and permission from Immtech, Par, through its employees,
consultants or other representatives will have the right during normal business
hours and at a time mutually agreed to inspect Immtech’s or its subcontractors’
or Affiliates’ manufacturing operations to determine whether or not Immtech is
complying in all respects with its obligations hereunder. Par
warrants that all such inspections and audits shall be carried out in a manner
calculated not to unreasonably interfere with Immtech’s, its subcontractors’ or
its Affiliates’ conduct of business and to insure the continued confidentiality
of Immtech’s business and technical information. Further, Par agrees to comply
with all of Immtech’s safety and security requirements during any visits to the
Immtech, its subcontractors’, or Affiliates’ facilities. Par agrees
to make promptly available to Immtech any external reports from such facility
visit(s).
Section
4.6 Manufacturing
Release Records and Data
Following
the Manufacture of each Batch of Product, and upon written request as required,
Immtech shall provide Par with properly completed copies of all Manufacturing
Release Records, including Manufacturing and Packaging Batch records prepared
in
accordance with the Specifications.
Section 4.7 Recordkeeping
Immtech
shall maintain true and accurate books, records, test and laboratory data,
reports and all other information relating to Manufacturing and Packaging under
this Agreement, including all information required to be maintained by the
Specifications and all Applicable Laws. Such information shall be maintained
in
forms, notebooks and records for a period of at least two (2) years from the
relevant finished Product expiration date or longer if required under Applicable
Laws.
Section
4.8 Finished Product Compliance
Upon
Product delivery by Immtech and acceptance by Par and pursuant to the Licensing
Agreement, Par shall be thereafter solely responsible for compliance with all
Applicable
Laws related to any subsequent labeling, packaging, and
any required testing of Product.
Section
4.9 Governmental Inspections and Requests
Immtech
shall immediately advise Par if an authorized agent of any Regulatory Authority
visits either Immtech or any Manufacturing Facility related to the Manufacturing
or Packaging of the Product. Immtech shall furnish to Par a copy of
the portions of the report relevant to the Product by such Regulatory Authority,
if any, within ten (10) days of Immtech’s receipt of such
report. Further, upon receipt of a Regulatory Authority request to
inspect the Facilities or audit Immtech’s books and records with respect to
Manufacturing and Testing under this Agreement, Immtech shall immediately notify
Par, and shall provide Par with a copy of any written document received from
such Regulatory Authority related to the Product. To the extent related to
Manufacturing or Packaging hereunder, Immtech shall provide to Par a copy of
any
proposed written response to any such inspection related to the Product prior
to
its submission and a reasonable opportunity for Par to review such
response.
Section
4.10 Product
Complaints
Par
will
notify Immtech within 5 calendar days of any customer complaints that relate
to
the Manufacture or Packaging of the Product in accordance with the Licensing
Agreement. Immtech shall conduct internal investigations to determine
the validity of the complaint. Immtech will use commercially
reasonable efforts to report the findings of such investigation to Par within
10
business days of notification. Any ADE reporting will be in
accordance with Section 9 of the Licensing Agreement. Par will be
responsible for customer response communications and will promptly deliver
copies of such responses to Immtech. Any complaint received by
Immtech that relates to the Product will be forwarded to Par within 5 calendar
days.
Section
4.11 Recall
In
the
event Immtech believes a recall, field alert, Product withdrawal or field
correction may be necessary with respect to any Product provided under this
Agreement, Immtech shall immediately notify Par in writing. Immtech
will not act to initiate a recall, field alert, Product withdrawal or field
correction without the express prior written approval of Par, unless otherwise
required by Applicable Laws and Immtech shall provide all necessary cooperation
and assistance to Par. In the event Par believes a recall, field
alert, Product withdrawal or field correction may be necessary with respect
to
any Product provided under this Agreement, Par shall immediately notify Immtech
in writing. Par will not act to initiate a recall, field alert, Product
withdrawal or field correction without the express prior written approval of
Immtech, unless otherwise required by Applicable Laws and Immtech shall provide
all necessary cooperation and assistance to Par. Immtech shall be
responsible for any recall, field alert, Product withdrawal or field correction;
provided, however, that the cost of any recall, field alert,
Product withdrawal or field correction shall be borne equally by the Parties,
except to the extent such recall, field alert, Product withdrawal or field
correction is caused by either Immtech’s or Par’s breach of its warranties,
representations or obligations under this Agreement, the Licensing
Agreement
or
Applicable Laws or its negligence or willful misconduct, in which case such
cost
shall be borne by the responsible Party. For purposes hereof, such
cost shall be limited to reasonable, actual and documented Administrative Costs
incurred by the Parties for such recall, withdrawal or correction, and
replacement of the Defective Product to be recalled. In the event of
a recall, Par shall provide to Immtech copies of distribution records in its
control and shall otherwise reasonably cooperate with Immtech in respect of
any
such recall.
ARTICLE
V - REPRESENTATIONS, WARRANTIES AND COVENANTS
Section
5. Limited
Warranty
Immtech
represents and warrants to Par that at the time of delivery of the Product
and
through label expiry date, provided that Par or any of affiliates, customers,
and or third parties, handle and/or store Product per specifications, cGMP,
USP
requirements, such Product will conform to and will have been Manufactured
and
Packaged in conformance with the Specifications and Applicable
Laws.
THE
LIMITED WARRANTY SET FORTH IN THIS SECTION 5.1 AND SECTIONS 4.1, 4.3(A) AND
4.3(B) IS IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF MERCHANTABILITY, WARRANTY OF NON-INFRINGEMENT AND ANY WARRANTY
OF
FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTY EXPRESSED IN THIS
SECTION 5.1 AND SECTIONS 4.1, 4.3(A) AND 4.3(B), IMMTECH MAKES NO OTHER
WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE MANUFACTURING OR
PACKAGING OF THE PRODUCT.
Section
5.2 Release
Responsibility.
Immtech,
as the Party responsible for release of the finished Product, warrants that
it
will not release any Batch of Product if the required final Product testing
indicates that the Product does not comply with the Specifications.
Section
5.3 Existence and
Power
Each
Party hereby represents and warrants to the other Party that such Party (i)
is
duly organized, validly existing and in good standing under the laws of the
state in which it is organized, (ii) has the corporate power and authority
and
the legal right to own and operate its property and assets, and to carry on
its
business as it is now being conducted, and (iii) is in compliance with all
requirements of applicable law, except to the extent that any noncompliance
would not materially adversely affect such Party’s ability to perform its
obligations under the Agreement.
Section
5.4 Authorization
and Enforcement of Obligations
Each
Party hereby represents and warrants to the other Party that such Party (i)
has
the corporate power and authority and the legal right to enter into this
Agreement and to
perform
its obligations hereunder and thereunder and (ii) has taken all necessary action
on its part to authorize the execution and delivery of the Agreement and the
performance of its obligations hereunder. The Agreement has been duly executed
and delivered on behalf of such Party, and constitutes a legal, valid, binding
obligation, enforceable against such Party in accordance with its
terms.
Section
5.5 No
Conflict
Each
Party hereby represents and warrants to the other Party that the execution
and
delivery of this Agreement and the performance of such Party’s obligations
hereunder (i) to not conflict with or violate any requirement of Applicable
Laws
or any material contractual obligation of such Party and (ii) do not materially
conflict with, or constitute a material default or require any consent under,
any material contractual obligation of such Party.
ARTICLE
VI – TERM AND TERMINATION
Section
6.1
Term. This Agreement shall commence on the Effective Date and
continue for a period that shall extend until the
termination of the Licensing Agreement.
Section
6.2
Termination for Breach.
If
either
Party commits a material breach or material default in the performance or
observance of any of its obligations under this Agreement, and such breach
or
default continues for a period of sixty (60) days after delivery by the other
Party of written notice reasonably detailing such breach or default, then the
non-breaching or non-defaulting Party shall have the right to terminate this
Agreement, with immediate effect, by giving written notice to the breaching
or
defaulting Party. The Parties shall retain all rights and remedies
(at law or in equity) in respect of any breach hereof.
Section
6.3. Effects of
Termination.
In
the
event of expiration of the applicable Term or termination of this Agreement,
all
rights and obligations of the parties hereunder shall cease, except that
termination or expiration shall not: (i) release either party from any liability
or obligation that at such time shall already have accrued or be owed, that
is
caused by an improper termination or that thereafter accrues from a breach
or
default prior to the effective date of such expiration or termination; and
(ii)
affect in any way the survival of any other right, duty or obligation of either
party hereto that is expressly stated elsewhere in this Agreement to survive
such expiration or termination.
[Signature
Page Follows]
IN
WITNESS WHEREOF, the Parties hereto
have caused this Agreement to be executed by their duly authorized
representatives as of the day and year first above written.
|
By:
/s/ ▇▇▇▇ ▇.
▇▇▇▇▇▇
Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇ Title:
Chairman and Chief Executive Officer
|
|
|
PAR
PHARMACEUTICAL, INC.
|
|
|
By:
/s/ ▇▇▇▇
▇▇▇▇▇▇▇
Name: ▇▇▇▇ ▇▇▇▇▇▇▇ Title: President,
Branded Products Division
|
|