EXHIBIT 10.37(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 patients with triglyceride levels between 200 mg/dL and 499 mg/dL
(inclusive).”


 


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 obtain a final FDA
approval of the Product for the indication HTG for patients with triglyceride
levels between 200 mg/dL and 499 mg/dL (inclusive); provided,
that, RELIANT shall not be required to fund more than USD [***] 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 50% 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.”


 






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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 # 21-654 or Full
Regulatory Approval for NDA # 21-853, manufacture and supply to RELIANT the
total of RELIANT’s requirements of the API for the Product for sale and
distribution in the Territory. Similarly, after FDA approval of any Additional
Product, PRONOVA shall supply to RELIANT the total of RELIANT’s requirements of
the API for the Additional Product for sale and distribution in the Territory.
The provisions of this Section 5 shall apply to the supply of API for
any Additional Product in the same manner as they apply to the supply of API
for the Product. The Parties agree that
following Full Regulatory Approval, they shall meet and agree to revised
forecasts and delivery dates for the Products (including, as applicable, the
provisions of Sections 5.2, 5.3 and 5.4).”


 


8.             New
Section 5.6(k) - Quality Agreement. Section 5.6(k) of the Original
Agreement shall be deleted in its entirety and replaced with the following:


 


“(k)         Quality
Agreement. By December 31, 2004, the Parties shall mutually agree upon an
intercompany quality agreement which will appropriately address regulatory,
operational and quality responsibilities (the “Quality Agreement”). The
Quality Agreement will include a key contact list for each Party.”


 


9.             Section
5.13 – Continuity of Supply. Section 5.13 of the Original Agreement
shall be deleted in its entirety and replaced with the following:


 


“5.13       Continuity of Supply. The Parties
agree that promptly following the date of this Agreement, they shall meet and
determine appropriate measures to qualify an additional manufacturing site.
PRONOVA agrees to use commercially reasonable efforts to qualify an additional
manufacturing site prior to one (1) year following the Full Regulatory
Approval. The License restrictions set out in Section 2.1 with respect
to PRONOVA shall not restrict PRONOVA from establishing additional
manufacturing sites in Puerto Rico or other parts of the Territory (and PRONOVA
shall provide RELIANT with reasonable advance written notice thereof).”


 


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10.           Section 6.1 – Minimum Purchase
Levels. Section 6.1 of the Original Agreement shall be deleted in
its entirety and replaced with the following:


 


“6.1         Base
Minimum Purchase Levels. Provided that PRONOVA is not in breach of its
supply obligations under Section 5, this Agreement will be subject to
RELIANT making at least the following purchases of API for Trade Product during
the first twelve month period following the First Commercial Sale and every
12-month period thereafter (each a “Commercialization Year”) prior to
Full Regulatory Approval (the “Reduced Base Minimum Purchase Levels”):


 


•                  1st
Commercialization Year: USD 3,000,000.


 


•                  2nd
Commercialization Year: USD 9,500,000.


 


•                  3rd
Commercialization Year and each subsequent year through 2013: USD 15,000,000.


 


•                  2014
and beyond: USD 6,000,000.


 


Following
Full Regulatory Approval, the Reduced Base Minimum
Purchase Levels shall be increased according to the formula specified below (the “Full Base
Minimum Purchase Levels” and, together with the Reduced Base Minimum
Purchase Levels, referred to herein as the “Base Minimum Purchase Levels”),
which Full Minimum Purchase Levels shall take effect from the date of Full Regulatory
Approval and shall be adjusted annually thereafter (following the date of the
Full Regulatory Approval, each such 365-day period shall constitute a “Post
Full Approval Commercialization Year” for the purposes of this Agreement).
Following Full Regulatory Approval, the Full Base Minimum Purchase Level shall
be calculated as follows:


 


[***]


 


provided, however, that, in no event, shall the Full Base Minimum Purchase Level exceed $[***] for any Post Full
Commericialization Year before 2014, and in no event, shall the Full Base
Minimum Purchase Level exceed USD [***] for any Post Full Commericialization
Year including any time period in or after 2014. A sample calculation of Full
Base Minimum Purchase Levels is set forth on Schedule 6.1 attached
hereto.”


 


In
the event that Full Regulatory Approval includes one or more conditions which,
when taken as a whole, would reasonably be expected to materially and adversely
impact the commercial potential of the Product for those patients with
triglyceride levels between 200 mg/dL and 499 mg/dL, the parties shall meet in
good faith to discuss appropriate adjustments to the Full Base Minimum Purchase
Levels. The Base Minimum Purchase Level may be reached by RELIANT by purchasing
API for Sample Product at the price for Trade Product, or by paying the
difference between actual Trade Product bought 


 






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during
the respective Commercialization Year and the applicable Base Minimum Purchase
Level in that year.”


 


In addition, the Original Agreement shall be
amended by adding thereto new Schedule 6.1 in the form attached hereto
as Exhibit C.


 


11.           Section 8.2 – Sales Force. Of
the Original Agreement shall be deleted in its entirety and replaced with the
following:


 


“Notwithstanding anything to the contrary
contained in this Section 8.2, until Full Regulatory Approval has been
received with respect to the Product, the number of sales representatives
actively detailing the Product shall be at least [***]. RELIANT shall have a
sales force of at least [***] representatives detailing the Product for the first
three years from the date of Full Regulatory Approval. In the event that Full
Regulatory Approval includes one or more conditions which, when taken as a
whole, would reasonably be expected to materially and adversely impact the
commercial potential of the Product for those patients with triglyceride levels
between 200 mg/dL and 499 mg/dL, the parties shall meet in good faith to
discuss appropriate adjustments to the minimum sales force required under this Section 8.2.”


 


12.           No Other Amendments. Except as
specifically amended hereby, the Original Agreement shall continue in full
force and effect as written.


 


13.           Entire Agreement. The Original
Agreement (including all Schedules and Exhibits attached thereto), as amended
by this Amendment (including all Schedules and Exhibits attached hereto),
constitutes the entire agreement between the Parties and their Affiliates
pertaining to the subject matter of hereof and thereof and supersedes all prior
agreements.


 


14.           Governing Law. This Letter
Amendment shall be governed by the laws of the State of New York, United States
of America, notwithstanding the provisions governing conflict of laws under
such New York law to the contrary and without giving effect to the United
Nations Convention on Contracts for the International Sale of Goods.


 


15.           Counterparts.
This Amendment may be executed in any number of counterparts, each of which
will be deemed to be an original and all of which taken together will be deemed
to constitute one and the same instrument. Counterparts may be executed either
in original or faxed form and the parties shall adopt any signatures received
by a receiving fax machine as original signatures of the parties. Any Party
providing its signature in faxed form will promptly forward to the other Party
an original of the signed copy of this Amendment that was so faxed.


 


Signature Page Follows


 






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IN WITNESS WHEREOF, the Parties hereto have duly executed this Amendment as of the
date first written above.


 


 


	
   

  	
  RELIANT PHARMACEUTICALS, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Title:

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  PRONOVA BIOCARE A.S.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Name:

  
	
   

  	
   

  	
  Title:

  
						



 

















 


EXHIBIT A


TITLE 21—FOOD AND DRUGS


 


 


CHAPTER I—FOOD AND DRUG ADMINISTRATION

DEPARTMENT OF HEALTH AND HUMAN SERVICES


 


 


SUBCHAPTER D - DRUGS FOR HUMAN USE


 


 


PART 314 — APPLICATIONS FOR FDA APPROVAL TO
MARKET A NEW DRUG


 


Subpart
B — Applications 


Sec.
314.72 Change in ownership of an application. 


 


(a)
An applicant may transfer ownership of its application. At the time of transfer
the new and former owners are required to submit information to the Food and Drug
Administration as follows:


 


(1)
The former owner shall submit a letter or other document that states that all
rights to the application have been transferred to the new owner.


 


(2)
The new owner shall submit an application form signed by the new owner and a
letter or other document containing the following:


 


(i)
The new owner’s commitment to agreements, promises, and conditions made by the
former owner and contained in the application;


 


(ii)
The date that the change in ownership is effective; and


 


(iii)
Either a statement that the new owner has a complete copy of the approved
application, including supplements and records that are required to be kept
under § 314.81, or a request for a copy of the application from Fad’s files.
FDA will provide a copy of the application to the new owner under the fee
schedule in § 20.45 of Fad’s public information regulations.


 


(b)
The new owner shall advise FDA about any change in the conditions in the
approved application under § 314.70, except the new owner may advise FDA in the
next annual report about a change in the drug product’s label or labeling to
change the product’s brand or the name of its manufacturer, packer, or
distributor.


 


[50
FR 7493, Feb. 22, 1985; 50 FR 14212, Apr. 11, 1985, as amended at 50 FR 21238,
May 23, 1985; 67 FR 9586, Mar. 4, 2002; 68 FR 25287, May 12, 2003]


 

















 


EXHIBIT B


 


Schedule 4.1


 


Payment Model


 


•                  USD 10,000,000
due and payable thirty (30) days after signing of the Agreement (which amount
the Parties agree has heretofore been paid in full); plus


 


•                  USD
15,000,000 due and payable after the date of FDA notification if the initial
review of NDA # 21-654 results in a final FDA approval for the indication HTG
with very high (>500 mg/dL) triglyceride levels, upon the later of (i)
thirty (30) days after  such
notification, and (ii) the transfer of the Registration for NDA #21-654 and NDA
# 21-853 to Reliant,


 


•                  USD
25,000,000 due and payable thirty days after the date of FDA notification of
Full Regulatory Approval of the Product for the indication HTG (the “Final
Approval Payment”). In the event that Full Regulatory Approval includes one or
more conditions which, when taken as a whole, would reasonably be expected to
materially and adversely impact the commercial potential of the Product for
those patients with triglyceride levels between 200 mg/dL and 499 mg/dL
(inclusive), the parties shall meet in good faith to discuss an appropriate
reduction in the final Approval Payment.


 

















 


EXHIBIT C


 


Schedule 6.1


 


Sample Calculation of Full Base Minimum Purchase Levels


 


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[***]:  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.