The Medicines Company
requests that the marked portions of the agreement be granted
confidential treatment under
Rule 24b-2 of the Securities Exchange Act of 1934.
AMENDMENT NO. 2 TO
AMENDED AND RESTATED DISTRIBUTION AGREEMENT
This is Amendment
No. 2 (this “Amendment” ) to the Amended
and Restated Distribution Agreement, effective as of
February 28, 2007, between The Medicines Company , a
Delaware corporation with offices at 8 Campus Drive, Parsippany, NJ
07054 (“ TMC ”), and Integrated
Commercialization Solutions, Inc., a California corporation with
offices at 3101 Gaylord Parkway, Frisco, TX 75034 (the
“Distributor” ). This Amendment is effective as
of October 1, 2008 (the “Effective
Date”).
WHEREAS, TMC and
Distributor are parties to the Amended and Restated Distribution
Agreement, effective as of February 28, 2007, as amended
effective as of November 7, 2007 (the
“Agreement” ), under which Distributor
distributes TMC’s product ANGIOMAX® (bivalirudin);
and
WHEREAS, the
parties now desire to amend the Agreement as more fully set forth
herein;
NOW, THEREFORE, in
consideration of the premises and the covenants and agreements
contained herein, and for other good and valuable consideration,
the receipt of which are hereby acknowledged, the parties agree as
follows:
1.
Defined Terms . Capitalized terms that are not defined in
this Amendment shall have the meanings given to them in the
Agreement.
2.
Product Addition . The parties agree that a new product,
Cleviprex™, shall be added to the Agreement and accordingly
the definition of Product in the Agreement shall be modified to
include both ANGIOMAX® (bivalirudin) and Cleviprex™
(clevidipine butyrate).
3.
Exhibit A . Exhibit A (Operating Guidelines) to
the Agreement is hereby deleted and replaced in its entirety with
the attached revised Exhibit A.
4.
Exhibit B . Exhibit B (Commercial Price List) to
the Agreement is hereby deleted and replaced in its entirety with
the attached revised Exhibit B.
5.
Exhibit D . Exhibit D (Fee Schedule) to the
Agreement is hereby deleted and replaced in its entirety with the
attached revised Exhibit D.
6. Effect
of Amendment . Except as expressly provided in this Amendment,
the Agreement will continue in full force according to its terms.
If there is any conflict between the Agreement and any provision of
this Amendment, this Amendment will control.
IN WITNESS
WHEREOF, the parties have executed this Amendment as of the
Effective Date.
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The
Medicines Company
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Integrated
Commercialization Solutions, Inc.
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/s/ John
Kelley
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By:
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/s/ David
Cheetham
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John
Kelley
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Name:
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David
Cheetham
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President,
C.O.O.
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Title:
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President
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2
These Operating
Guidelines are incorporated into the Distribution Agreement between
The Medicines Company (“TMC”) and Integrated
Commercialization Solutions, Inc. (“Distributor”),
effective as of the Effective Date, as amended (the
“Agreement”). Capitalized terms not otherwise defined
in these Operating Guidelines will have the same meaning as set
forth in the Agreement.
In performing its
obligations under the Agreement, Distributor will follow these
Operating Guidelines. The Operating Guidelines are in addition to
any SOPs that have been approved by TMC for use by Distributor in
the performance of services.
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1.0
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WAREHOUSING
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1.1
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Distributor will maintain its
warehouse facility in accordance with and will comply with all
federal, state and local laws, rules and regulations.
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1.2
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Distributor will maintain SOPs
appropriate for a pharmaceutical distribution center operating
environment.
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1.3
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Distributor will comply with all
storage, handling and shipping conditions designated by TMC for the
Product.
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1.4
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The
Product will be stored by Distributor in a temperature-controlled
environment in conjunction with defined Product label requirements.
TMC will ensure that the storage requirements are identified on the
package label. TMC will ensure that the storage requirements, lot
number and expiry date will be in human readable format and the
Product NDC number will be in an acceptable barcode format on the
unit carton. Product will be stored in areas designed to be
continuously monitored and will be periodically validated for the
temperature range specified for the Product. Distributor will
maintain continuous warehouse environmental monitoring. Distributor
will provide such records to TMC upon written request.
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1.5
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Product will be stored in an area
with secured access, accessible only to authorized Distributor
personnel.
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2.0
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RECEIVING
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2.1
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TMC
will arrange transportation services to transfer the Product to
Distributor. TMC will notify Distributor of the specific delivery
schedule.
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2.2
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Each individual unit of TMC’s
Product will be labeled with a barcode representing the
Product’s NDC number, lot number, and expiration date. This
information will also be in human readable format.
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2.3
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TMC
will ship in increments of one shipper (30 boxes of 10 vials each,
or 300 vials)
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2.4
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Shipping terms from TMC to
Distributor will be FOB Destination. Distributor’s signature
on the carrier’s bill of lading is an acknowledgment only of
Distributor’s receipt of Product and transfer of
ownership.
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2.5
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Distributor will receive each
shipment into a secure receiving area and perform all requirements
as detailed in Distributor’s receiving SOP.
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2.6
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Distributor will count and inspect
the exterior packaging of the Product.
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2.7
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Distributor will move Product from
the receiving area to storage following Distributor
SOPs.
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3.0
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INVENTORY
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3
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3.1
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Inventory will be received, tracked
and controlled on Distributor’s warehouse management system
by item number, lot number, expiration date, and quantity of
individual units. An individual unit consists of 10 vials of
Product.
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3.2
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Distributor will use its
commercially reasonable efforts to maintain accurate and timely
inventory records. Inventory data will be made available to TMC as
described in Exhibit C of the Agreement.
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3.3
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TMC
or its designee may conduct a complete physical inventory once per
calendar year, upon reasonable notice.
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3.4
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Distributor will receive returned
Product according to Distributor’s SOP and TMC’s
Returned Goods Policy.
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4.0
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PRODUCT
DISTRIBUTION
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4.1
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Orders will only be shipped from the
Distributor to Ship-To Customers.
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4.2
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Orders approved and available for
processing (pick & pack) by 6:00 p.m. Central Time Monday
through Friday will be shipped to the Ship-to Customer via standard
ground delivery service for Angiomax and via standard overnight
delivery service for Cleviprex. Orders processed on Fridays will be
shipped on Sunday for delivery on Monday. Standard delivery is
typically made by 10:30 a.m. The foregoing schedule does not
apply to the following holidays: Christmas Day, New Year’s
Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day
and the day after Thanksgiving. Distributor shall make commercially
reasonable provisions for emergency and weekend orders. Additional
shipping and handling costs for such orders shall be billed to the
Bill- To Customer.
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4.3
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Distributor will use commercially
reasonable efforts to comply with First-to-Expire, First-Out
(FEFO) inventory allocation.
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4.4
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Distributor will perform quality
verification on all TMC shipments by an individual other than the
employee who picked the order. Distributor will use best efforts to
pick, check, pack and ship accurately all customer
orders.
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4.5
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Distributor will manage shipping
supplies, including supplier selection, stock replenishment,
inventory record keeping and storage.
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5.0
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TRANSPORTATION
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5.1
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Distributor will be responsible for
selecting a common carrier(s) to deliver product
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