exv10w4






Exhibit 10.4




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”).



Recitals




     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, CleviprexTM, shall be added
to the Agreement and accordingly the definition of Product in the Agreement shall be modified to
include both ANGIOMAX® (bivalirudin) and CleviprexTM (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.



	 	 	 	 	 	 	 
	The Medicines Company	 	Integrated Commercialization Solutions, Inc.
	 
	 	 	 	 	 	 
	By:

	 	/s/ John Kelley
	 	By:
	 	/s/ David Cheetham
	 

	 	 
	 	 	 	 
	Name:

	 	John Kelley
	 	Name:
	 	David Cheetham
	Title:

	 	President, C.O.O.
	 	Title:
	 	President






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REVISED EXHIBIT A




Operating Guidelines




     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.




	1.0	 	WAREHOUSING
	 
	1.1	 	Distributor will maintain its warehouse facility in accordance with and will comply with all
federal, state and local laws, rules and regulations.
	 
	1.2	 	Distributor will maintain SOPs appropriate for a pharmaceutical distribution center operating
environment.
	 
	1.3	 	Distributor will comply with all storage, handling and shipping conditions designated by TMC
for the Product.
	 
	1.4	 	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.
	 
	1.5	 	Product will be stored in an area with secured access, accessible only to authorized
Distributor personnel.
	 
	2.0	 	RECEIVING
	 
	2.1	 	TMC will arrange transportation services to transfer the Product to Distributor. TMC will
notify Distributor of the specific delivery schedule.
	 
	2.2	 	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.
	 
	2.3	 	TMC will ship in increments of one shipper (30 boxes of 10 vials each, or 300 vials)
	 
	2.4	 	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.
	 
	2.5	 	Distributor will receive each shipment into a secure receiving area and perform all
requirements as detailed in Distributor’s receiving SOP.
	 
	2.6	 	Distributor will count and inspect the exterior packaging of the Product.
	 
	2.7	 	Distributor will move Product from the receiving area to storage following Distributor SOPs.
	 
	3.0	 	INVENTORY




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	3.1	 	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.
	 
	3.2	 	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.
	 
	3.3	 	TMC or its designee may conduct a complete physical inventory once per calendar year, upon
reasonable notice.
	 
	3.4	 	Distributor will receive returned Product according to Distributor’s SOP and TMC’s Returned
Goods Policy.
	 
	4.0	 	PRODUCT DISTRIBUTION
	 
	4.1	 	Orders will only be shipped from the Distributor to Ship-To Customers.
	 
	4.2	 	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.
	 
	4.3	 	Distributor will use commercially reasonable efforts to comply with First-to-Expire,
First-Out (FEFO) inventory allocation.
	 
	4.4	 	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.
	 
	4.5	 	Distributor will manage shipping supplies, including supplier selection, stock replenishment,
inventory record keeping and storage.
	 
	5.0	 	TRANSPORTATION
	 
	5.1	 	Distributor will be responsible for selecting a common carrier(s) to deliver product to
Ship-To Customers the next day.
	 
	5.2	 	No Product will be delivered outside the Territory.
	 
	5.3	 	There will be no additional shipping surcharges applied to any shipments delivered within the
Territory.
	 
	5.4	 	Distributor, at the request of the TMC, will provide proof of delivery for specific Ship-To
Customer shipments up to six months after time of delivery. Signature should be required at
time of product delivery to Ship-To Customers on all shipments.
	 
	6.0	 	CUSTOMER SERVICE
	 
	6.1	 	Distributor will provide a dedicated inbound phone line (or lines) for Distributor’s
customers to phone in purchase orders, for inquiries, and for general information.
	 
	6.2	 	Distributor will establish and maintain a dedicated webpage for customers to place orders,
submit inquiries and obtain general information.
	 
	6.3	 	Distributor will staff the inbound phone line from 7:30 a.m. — 7:00 p.m. Central Time, Monday
through Friday, except for the following holidays: Christmas Day, New Year’s Day, Memorial
Day, Independence Day, Labor Day, Thanksgiving Day and the day after Thanksgiving.




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	6.4	 	Distributor will train Distributor’s customer service representative(s) and backup
representative(s), and will document the date and nature of such training. TMC will provide
company and Product specific information for training of the customer service representatives
assigned to TMC. TMC will have the right to review all training materials provided to
customer service representatives.
	 
	6.5	 	Distributor will be responsible for initial set up and on-going maintenance of customer
master files, including bill-to files for Bill-To Customers and ship-to files for Ship-To
Customers.
	 
	6.6	 	Distributor will accept customer orders by phone, electronic data interchange (EDI), mail,
fax, or internet. Distributor will maintain records of all customer orders.
	 
	6.7	 	Distributor will use commercially reasonable efforts to answer inbound phone calls within the
first thirty (30) seconds.
	 
	6.8	 	As a backup to the customer service representatives, a voice mail system will be maintained
to collect messages from customers.
	 
	6.9	 	Distributor’s customer service representatives will re-route all misdirected calls to the
appropriate vendors designated by TMC.
	 
	7.0	 	ORDER ENTRY
	 
	7.1	 	The minimum order quantity will be:
	 
	 	 	Angiomax NDC 65293-001-01 one pack of 10 vials

Cleviprex NDC 65293-002-011 50mg vials Six cartons of 10 vials

Cleviprex NDC 65293-002-055 25mg vials 12 cartons of 10 vials

	 
	7.2	 	Distributor will use commercially reasonable efforts to enter orders accurately.
	 
	8.0	 	CUSTOMER LIST AND APPROVAL
	 
	8.1	 	Distributor will require all customers to complete and submit its then-current Business
Application. Distributor will refuse to fill orders of Product until the customer’s Business
Application has been approved by Distributor.
	 
	8.2	 	The initial Bill-To Customer list consists of the following :





	 	 	 
	Wholesalers	 	Ship-to Customers
	[* *]

	 	[* *] 







	8.3	 	As stated in the Section 3.3.1 of the Agreement, Distributor is responsible for accounts
receivable management for the Bill-To Customers.
	 
	8.4	 	TMC National Accounts will work with Bill-To Customers in good faith to assist the
Distributor in collecting late payments due to the Distributor and assist in resolving any
other outstanding ordering, invoicing, or related disputes.
	 
	9.0	 	RECOGNITION OF TMC CONTRACTS




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	9.1	 	Any Ship-To Customer having a TMC Contract may request purchase of products from a Wholesaler
or Distributor at the prices established under the TMC Contract.
	 
	9.2	 	TMC will provide a list of customers eligible under TMC Contracts to Distributor quarterly,
with periodic updates as required; Distributor will be responsible for informing Wholesalers
of such TMC Contracts.
	 
	9.3	 	Distributor will require Wholesalers to continue to recognize and administer TMC Contracts,
provided that they remain valid and enforceable under Applicable Law.
	 
	9.4	 	TMC will promptly inform Distributor of changes to TMC Contracts so that Distributor may
inform Wholesalers. Such changes will be retroactive to the date agreed upon by TMC and the
Ship-To Customer. Upon 20 days prior written notification by TMC that a TMC Contract has been
terminated, Distributor will require Wholesalers to promptly cease selling Product to that
Ship-To Customer under the terms of that TMC Contract.
	 
	10.0	 	PRODUCT COMPLAINTS
	 
	Distributor shall notify TMC of any Product complaints from Bill-To Customers. TMC shall reimburse
Distributor for all costs associated with Product complaints.
	 
	11.0	 	CHARGEBACKS
	 
	11.1	 	TMC may enter into prime vendor arrangements for select contract or government
mandated pricing arrangements.
	 
	11.2	 	Distributor, on behalf of TMC, will process chargebacks with reconciliation of
chargeback discrepancies within five (5) working days. Distributor’s chargeback
SOPs will define the parameters available to Distributor to resolve discrepancies
between TMC’s contract terms and conditions and the chargeback submitted by the
customer.
	 
	11.3	 	All chargebacks will be processed according to the chargeback policy for TMC as
stated in Exhibit E to the Agreement.
	 
	11.4	 	All validated chargeback submissions will be settled via credit invoice to the
appropriate Bill-To Customer. TMC will not make advance payments or authorize
advance deductions of chargebacks.
	 
	11.5	 	TMC will reconcile and make payment to Distributor for chargebacks credited to
Bill-To Customers on a monthly basis.
	 
	11.6	 	Distributor will make best efforts to process chargebacks within three (3)
business days for electronic chargebacks and within five (5) business days for
hard copy chargebacks.
	 
	11.7	 	Distributor will provide the necessary reports to ensure TMC can comply with the
reporting requirements of Medicaid (OBRA), Veterans HealthCare Act, PHS Covered
Entities, and state rebate programs.
	 
	11.8	 	TMC will provide a list of customers eligible under TMC contracts to Distributor
quarterly with periodic updates as required. All notifications will be provided
to Distributor by TMC in writing 5 business days in advance of contract effective
date.




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REVISED EXHIBIT B




Commercial Price List




	 	 	 
	Product Name:

	 	ANGIOMAX® (bivalirudin) for Injection
	NDC#

	 	65293-001-01
	Drug Type:

	 	RX
	Package Size:

	 	Carton (10 single use vials)
	Dosage Form:

	 	250mg vial
	Current WAC Price*:

	 	$[**]per Carton, (*which may change from time to time)
	 
	 	 
	Product Name:

	 	CleviprexTM (clevidipine butyrate)
	NDC#

	 	65293-002-011
	Drug Type:

	 	RX
	Package Size:

	 	Carton (10 single use vials)
	Dosage Form:

	 	50mg vial
	Current WAC Price*:

	 	$[**] per Carton, (*which may change from time to time)
	 
	 	 
	Product Name:

	 	CleviprexTM (clevidipine butyrate)
	NDC#

	 	65293-002-055
	Drug Type:

	 	RX
	Package Size:

	 	Carton (10 single use vials)
	Dosage Form:

	 	25mg vial
	Current WAC Price*:

	 	$[**] per Carton, (*which may change from time to time)






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REVISED EXHIBIT D




					
	Services
	 	 	 	Fee







	A.	 	Development Fees (previously paid) 
	 
	B.	 	Customer Service and Distribution 





					
	 
	Monthly Management Fee
	 	 	 	Percentage of WAC

(see chart below)







	 	•	 	Warehousing Management and Inventory Administration
	 
	 	•	 	Customer Service / Order Entry
	 
	 	•	 	Distribution Services
	 
	 	•	 	Invoicing and Accounts Receivable Management
	 
	 	•	 	Direct Account Set Up
	 
	 	•	 	Information Technology





	 	 	 	 	 
	 	 	Drop Ship and Direct Hospital 	 	 
	Distribution Model	 	Shipment Channel	 	Wholesaler Stocking
	Percentage of WAC Applied to Gross Sales to TMC Direct for Cleviprex
	 	N/A	 	[**]%
	 
	Percentage of WAC Applied to Gross Sales to TMC Direct for Angiomax
	 	[**]%	 	[**]%





 




					
	**   Direct to Hospital Fee



	 	$[**]/shipment 
additional fee







	C.	 	Contract Pricing (provided in Section 5.4)
	 
	 	 	TMC will reimburse Distributor monthly for any contract sales administered as a direct price
(anything less than current WAC of the product) at time of sale. Reimbursement amount to
Distributor is current WAC at time of contract sale minus contract price.
	 
	 	 	Any direct pricing will be provided by TMC to Distributor.
	 
	D.	 	Guaranteed Amount
	 
	 	 	As additional consideration for the services and obligations of Distributor under this
Agreement, TMC guarantees that in each twelve month period (or portion thereof) during the
term of this Agreement, beginning on October 1, 2007, Distributor will earn, in addition to
the Monthly Management Fee, an amount equal to the greater of (A) [**] multiplied by
Distributor’s Angiomax sales for the applicable twelve month period (or portion thereof),
measured at then current WAC (the “Guaranteed Amount”), and (B) [**]; provided that
(i) for the sole purpose of calculating the Guaranteed Amount, WAC shall be no less than the
WAC in effect on the Effective Date, and (ii) the Incremental Margin shall not include any
margin associated with special programs or Product inventory supplied to Distributor at a
discount that is passed to the Distributor’s customers. In the event that the Incremental
Margin is less the Guaranteed Amount for the applicable twelve month period (or portion
thereof), Distributor will invoice TMC for the




8









 






	 	 	amount of the deficiency within 30 days following the end of such period, and TMC shall pay
the invoiced deficiency to Distributor within 30 days after the date of the invoice. The
Guaranteed Amount shall be renegotiated on an annual basis, effective October 1, 2008.
	 	 	

	 	 	Examples of calculation of the Guaranteed Amount:






	 	 	 	[**]






9