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AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT

Supply Agreement

AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT | Document Parties: Reliant Pharmaceuticals, Inc You are currently viewing:
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Reliant Pharmaceuticals, Inc

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Title: AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT
Date: 5/20/2005

AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT, Parties: reliant pharmaceuticals  inc
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Exhibit 10.30(b)

 

AMENDMENT NO. 1 TO

LICENSE AND SUPPLY AGREEMENT

 

This AMENDMENT NO. 1 TO LICENSE AND SUPPLY AGREEMENT (this “ Amendment ”) is entered into as of November 19, 2004, by and between PRONOVA BIOCARE A.S., a corporation incorporated under the laws of Norway (“ Pronova ”), located at Postboks 420, Vollsveien 6, NO-1327, Lysaker, Norway, and Reliant Pharmaceuticals, Inc., a Delaware corporation (“ Reliant ”), located at 110 Allen Road, Liberty Corner, New Jersey, 07938.

 

RECITALS

 

WHEREAS , Reliant and Pronova are parties to that certain License and Supply Agreement, dated as of August 9, 2004 (the “ Original Agreement ”); and

 

WHEREAS , the parties desire to amend the Original Agreement in the manner set forth herein.

 

NOW, THEREFORE , for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, Pronova and Reliant hereby agree to be bound as follows:

 

1. Definitions . Capitalized terms used but not defined herein shall have the respective meanings given to such terms in the Original Agreement, as amended hereby.

 

2. Section 1 - Amended Definitions . The following definitions as contained in Section 1 of the Original Agreement shall be deleted in their entirety and replaced with the following:

 

“1.6 “ API ” means the K85EE active pharmaceutical ingredient with Specifications set forth in Schedule 1.6 , as more particularly described in NDA #21-654 and/or NDA #21-853 for Omacor ® .”

 

“1.23 “ Product ” means the pharmaceutical product containing the API and certain excipients described in NDA #21-654 and/or NDA #21-853 for Omacor ® , including any and all dosage forms, formulas, strengths and package sizes and types thereof, whether or not currently marketed, and whether or not sold on a prescription or over-the-counter (OTC) basis, which is covered in whole or in part, or is made or used by a process or method covered in whole or in part, by at least one unexpired issued claim in the Patents in the Territory or by Product Know-How, in which any such process, product or part thereof is made, used or sold.”

 

“1.26 “ Registrations ” means all regulatory approvals, filings, applications and similar materials applicable to the Product or any Additional Product in the Territory, including, without limitation, any Drug Identification Numbers (“ DINs ”), Investigational New Drug Applications (“ INDs ”), NDAs, chemistry, manufacturing and control (“ CMC ”) data, pharmaceutical development reports, and any reference materials

 

 


for API, related substances, degradation products and intermediates, in each case with all supplements and amendments thereto, applicable to the Product or any Additional Product in the Territory, and all documents, correspondence and other materials related thereto issued or sent by or to any Governmental Authority including, without limitation, the Registration filing for the Product as more particularly described in NDA # 21-654 and/or NDA # 21-853 for Omacor ® .”

 

3. Section 1 – New Definition of “Full Regulatory Approval” . The Original Agreement shall be amended by adding the following new definition as Section 1.13A :

 

“1.13A “ Full Regulatory Approval ” means, with respect to the Product, the approval or authorization granted by a Regulatory Authority (FDA) for NDA # 21-853 in the Territory for the initial and ongoing commercialization of the Product for [***].”

 

4. Section 3.2 – FDA Approval of Product Registration . The following sentence shall be added to the end of Section 3.2 of the Original Agreement:

 

“Reliant shall complete and file the “new owner” requirements as outlined in 21 CFR 314.72, a copy of which is attached hereto as Exhibit 3.2 , within two (2) business days of notification that Abbott has filed a transfer request for NDA 21-654 with the FDA (as contemplated by Section 3.7(c) of Amendment No. 1 to the Abbott Agreement, dated as of November 11, 2004); provided, however , that nothing herein shall be deemed to create any liability or other obligation of Reliant or any of its Affiliates to Abbott or any of its Affiliates under the Abbott Agreement (as amended) or otherwise.”

 

In addition, the Original Agreement shall be amended by adding thereto new Exhibit 3.2 in the form attached hereto as Exhibit A .

 

5. Section 3.3 – Additional Development Work for Product . Section 3.3 of the Original Agreement shall be deleted in its entirety and replaced with the following:

 

“3.3 “ Additional Development Work for Product . RELIANT will contribute to and fund all further development of the Product (other than development costs otherwise funded by Abbott) relating to NDA #21-853 in order to [***]; provided , that, RELIANT shall not be required to fund more than [***] in further development work under this Section 3.3; provided, further , that PRONOVA shall be solely responsible for any expenses with respect to supply chain or manufacturing issues raised by the FDA. Upon Full Regulatory Approval, RELIANT will pay to PRONOVA the final approval payment pursuant to Section 4.1 (as set out in Schedule 4.1 ), which will be reduced by [***] of all pre-marketing development out of pocket costs and amounts paid to unrelated third-parties actually incurred prior to final FDA approval by or on behalf of RELIANT in accordance with this Section 3.3 , provided that in no event shall such reduction reduce the final approval payment below USD 0.”

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

[***]: Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 

2

 


6. Section 4.1 – Up-Front, Approvable and Final Approval Payments . Section 4.1 of the Original Agreement shall be deleted in its entirety and replaced with the following:

 

“4.1 Up Front, Approvable and Final Approval Payments . In consideration of the License and other rights granted to RELIANT under this Agreement, RELIANT shall pay to PRONOVA, in accordance with this Agreement, payments according to the model set out in Schedule 4.1 attached hereto.”

 

In addition, Schedule 4.1 to the Original Agreement shall be deleted and replaced in its entirety with the amended Schedule 4.1 in the form attached hereto as Exhibit B .

 

7. Section 5.1 – Manufacture and Supply . Section 5.1 of the Original Agreement shall be deleted in its entirety and replaced with the following:

 

“5.1 Manufacture and Supply . Subject to Section 5.12 , PRONOVA shall, after FDA approval of the Product for the indication HTG under NDA # 2


 
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