FOURTH AMENDMENT TO SECOND AMENDED AND RESTATED DISTRIBUTION AGREEMENT
Exhibit 10.2
Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Double asterisks denote omissions. | ||||
FOURTH AMENDMENT TO
SECOND AMENDED AND RESTATED DISTRIBUTION AGREEMENT
SECOND AMENDED AND RESTATED DISTRIBUTION AGREEMENT
This Fourth Amendment to Second Amended and Restated Distribution Agreement (this “Amendment”) is between The Medicines Company, a Delaware corporation with offices at 0 Xxxxxx Xxx, Xxxxxxxxxx, XX 00000 (“MDCO”), and Integrated Commercialization Solutions, Inc., a California corporation with offices at 0000 Xxxxxxx Xxxxxxx, Xxxxxx, XX 00000 (“Distributor”). This Amendment is effective as of May 1st, 2013 (the “Amendment Effective Date”). MDCO and Distributor shall, at times throughout this Amendment, be referred to individually as a “Party” and collectively as the “Parties”.
RECITALS
A. | MDCO and Distributor are parties to a Second Amended and Restated Distribution Agreement effective as of October 1, 2010, as amended by the First Amendment dated July 1, 2011, the Second Amendment dated September 1, 2011 and the Third Amendment dated April 23, 2012 (the “Agreement”); |
B. | Under the Agreement, among other things, MDCO engaged Distributor to perform distribution services for certain of MDCO’ s pharmaceutical products; and |
C. | The Parties now wish to amend the Agreement in certain respects. |
AMENDMENT
NOW THEREFORE, the parties agree as follows:
1. | Defined Terms. Capitalized terms in this Amendment that are not defined in this Amendment have the meanings given to them in the Agreement. If there is any conflict between the Agreement and any provision of this Amendment, this Amendment will control. |
2. | Section 6.1. Section 6.1.1 (c) of the Agreement is deleted in its entirety and replaced with the following: |
MDCO owns or holds the duly approved Biologics License Application (as such term is used in the Public Health Service Act, Title 21, United States Code), or the duly approved New Drug Application or Abbreviated New Drug Application (as such terms are used in the Federal Food, Drug and Cosmetic Act, Title 21, United States Code), for Angiomax® (bivalirudin) and Cleviprex® (clevidipine), and no drug pedigree or prior sales history for any of the other
Products listed on Revised Schedule B is required to be provided in connection with the distribution of such Products under applicable federal or state drug pedigree laws.
3. | Exhibit B. The Parties agree that Exhibit B to the Agreement is hereby deleted in its entirety and replaced with the attached Revised Exhibit B. |
4. | Exhibit D. The Parties agree that Exhibit D to the Agreement is hereby deleted in its entirety and replaced with the attached Revised Exhibit D. |
5. | No Other Changes. Except as otherwise provided in this Amendment, the terms and conditions of the Agreement will continue in full force, nothing in the Amendment modifies any term or provision in the Agreement or the Continuing Guaranty. |
IN WITNESS WHEREOF, the Parties have executed this Amendment as of the Amendment Effective Date.
INTEGRATED COMMERCIALIZATION SOLUTIONS, INC. | THE MEDICINES COMPANY |
By: /s/ Xxxxxxx X. XxXxxxxx | By: /s/ Xxxxx Xxxxx 4/29/13 |
Name: Xxxxxxx X. XxXxxxxx | Name: Xxxxx Xxxxx |
Title: SVP, GM | Title: VP, Global Distribution & Supply Chain |
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REVISED EXHIBIT B
Product List
Product Name: | ANGIOMAX® (bivalirudin) for Injection |
NDC# | 00000-000-00 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 250mg vial |
Current WAC Price*: | $[**] per Carton, (*which may change from time to time at MDCO’s sole discretion) |
Case Pack Size | Thirty (30) Cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | ANGIOMAX® (bivalirudin) Nova Plus for Injection |
NDC# | 00000-000-00 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 250mg vial |
Current WAC Price*: | $[**] per Carton, (*which may change from time to time at MDCO’s sole discretion) |
Case Pack Size | Thirty (30) Cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | ARGATROBAN for Injection |
NDC# | 00000-000-00 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 50mg vial |
Current WAC Price*: | $[**] Carton, (*which may change from time to time at MDCO’s sole discretion) |
Case Pack Size | Four (4) Cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Cleviprex® (clevidipine) Injectable Emulsion |
NDC# | 0000-000-00 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 50mg vial |
Current WAC Price*: | $[**] Carton, (*which may change from time to time at MDCO’s sole discretion) |
Case Pack Size | Six (6) Cartons |
Shipping and Storage Requirements: | 2 to 8ºC |
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Product Name: | Cleviprex® (clevidipine) Injectable Emulsion |
NDC# | 0000-000-00 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 25mg vial |
Current WAC Price*: | $[**] Carton, (*which may change from time to time at MDCO’s sole discretion) |
Case Pack Size | Twelve (12) Cartons |
Shipping and Storage Requirements: | 2 to 8ºC |
Product Name: | Rocuronium 50mg/5ml (2-8C) |
NDC# | 6529342610 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 50mg vial 10mg/ml |
Current WAC Price*: | $[**] |
Case Pack Size | 48 cartons |
Shipping and Storage Requirements: | 2 to 8ºC |
Product Name: | Rocuronium 100mg/10ml |
NDC# | 0000000000 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 100mg vial 10mg/ml |
Current WAC Price*: | $[**] |
Case Pack Size | 48 cartons |
Shipping and Storage Requirements: | 2 to 8ºC |
Product Name: | Ondansetron 4mg/2ml |
NDC# | 6529337325 |
Drug Type: | RX |
Sellable Package Size: | Carton (25 single use vials) |
Dosage Form: | 4mg vial 2mg/ml |
Current WAC Price*: | $[**] |
Case Pack Size | 40 cartons |
Shipping and Storage Requirements: | 20 to 25ºC PROTECT FROM LIGHT |
Product Name: | Ondansetron 40mg/20ml |
NDC# | 6529337401 |
Drug Type: | RX |
Sellable Package Size: | Carton (1 single use carton) |
Dosage Form: | 40mg vial 2mg/ml |
Current WAC Price*: | $[**] |
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Case Pack Size | 100 cartons |
Shipping and Storage Requirements: | 20 to 25ºC PROTECT FROM LIGHT |
Product Name: | Midazolam 2mg/2ml CIV |
NDC# | 6529341125 |
Drug Type: | RX |
Sellable Package Size: | Carton (25 single use vials) |
Dosage Form: | 2mg vial 1mg/1ml |
Current WAC Price*: | $[**] |
Case Pack Size | 40 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Midazolam 10mg/2m CIV |
NDC# | 6529341210 |
Drug Type: | RX |
Sellable Package Size: | Cartons (10 single use vials) |
Dosage Form: | 10mg vial 1mg/1ml |
Current WAC Price*: | $[**] |
Case Pack Size | 48 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Midazolam 10mg/2ml CIV |
NDC# | 6529341310 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 10mg vial 5mg/1ml |
Current WAC Price*: | $[**] |
Case Pack Size | 48 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Midazolam 25mg/5ml CIV |
NDC# | 6529341410 |
Drug Type: | RX |
Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 25mg vial 5mg/ml |
Current WAC Price*: | $[**] |
Case Pack Size | 48 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Midazolam 50mg/10ml CIV |
NDC# | 6529341510 |
Drug Type: | RX |
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Sellable Package Size: | Carton (10 single use vials) |
Dosage Form: | 50mg vial 5mg/ml |
Current WAC Price*: | $[**] |
Case Pack Size | 48 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Midazolam 5mg/5ml CIV |
NDC# | 0000000000 |
Drug Type: | RX |
Sellable Package Size: | Carton (25 single use vials) |
Dosage Form: | 5mg vial 1mg/1ml |
Current WAC Price*: | $[**] |
Case Pack Size | 30 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Midazolam 5mg/1ml CIV |
NDC# | 6529341725 |
Drug Type: | RX |
Sellable Package Size: | Carton (25 single use vials) |
Dosage Form: | 5mg vial 5mg/1ml |
Current WAC Price*: | $[**] |
Case Pack Size | 40 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Recothrom Spray Kit Only |
NDC# | 28400070017 |
Drug Type: | RX |
Sellable Package Size: | Carton |
Dosage Form: | N/A |
Current WAC Price*: | $[**] |
Case Pack Size | 6 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Recothrom 5,000 IU Kit |
NDC# | 28400010541 |
Drug Type: | RX |
Sellable Package Size: | Carton |
Dosage Form: | 5,000 IU |
Current WAC Price*: | $[**] |
Case Pack Size | 12 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
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Product Name: | Recothrom 20,000 IU Kit |
NDC# | 28400012041 |
Drug Type: | RX |
Sellable Package Size: | Carton |
Dosage Form: | 20,000 IU |
Current WAC Price*: | $[**] |
Case Pack Size | 6 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
Product Name: | Recothrom 20,000 IU Kit w/spray |
NDC# | 28400012050 |
Drug Type: | RX |
Sellable Package Size: | Carton |
Dosage Form: | 20,000 IU |
Current WAC Price*: | $[**] |
Case Pack Size | 6 cartons |
Shipping and Storage Requirements: | 20 to 25ºC |
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REVISED EXHIBIT D
Fee Schedule
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Services | Fee |
A. Marketing, Sales, Customer Service and Distribution | |
Fees include the following | Percentage of WAC (see below) |
§ Warehousing Management and Inventory Administration | |
§ Customer Service/Order Entry | |
§ Marketing and Distribution Services | |
§ Invoicing and Accounts Receivable Management | |
§ Direct Account Set Up | |
§ Information Technology | |
Wholesaler Stocking | Percent of WAC |
Angiomax and Angiomax NovaPlus | [**]% |
Cleviprex | [**]% |
Argatroban | [**]% |
Recothrom | [**]% |
Drop-Shipments / Direct Accounts | Percent of WAC |
Angiomax and Angiomax NovaPlus | [**]% |
Cleviprex | [**]% |
Argatroban | [**]% |
Recothrom | [**]% |
**Direct to End-User Fee—Cleviprex Only | $[**] shipment additional fee |
***Freight Upcharge (does not include Cleviprex | MDCO to reimburse Distributor for upgrade From Ground to Next Day Saver or Next Day Air |
Generic Products | Percent of WAC |
Fee for Service | [**]% |
Prompt Pay Discount | [**]% |
B. Contract Pricing (provided in Section 5.4)
MDCO will reimburse Distributor monthly for any MDCO 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.
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Any direct pricing will be provided by MDCO to Distributor.
C. Pricing Actions
Distributor shall realize no benefit or penalty from pricing actions. In the event of a price increase on the Products, Distributor shall deduct the difference in value of the Products held in Distributor inventory held on the day prior to the price increase. For example, the day prior to the price increase the value of the products is $1,000,000 and a 6% price increase raises the value of the same inventory to $1,060,000 on the same number of units of Products. Distributor shall deduct the difference, $60,000, from the next Service Fee.
In the event of a price decrease on the Products, Distributor shall add the difference in value of the Products held in Distributor inventory held on the day prior to the price decrease. For example, the day prior to the price decrease the value of the products is $1,000,000 and a 6% price decrease lowers the value of the same inventory to $940,000 on the same number of units of Products. Distributor shall add the difference, $60,000, to the next Service Fee.
D. Early Renewal Incentive
In recognition of MDCO’s early renewal of agreement, Distributor will reduce all monthly invoices for the term of this Agreement by an amount equal to $[**] or $[**] over 36 months. This incentive is effective between October 1, 2010 and September 30, 2013.
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