Exhibit 10.4.1

Confidential portions of this document have been omitted and filed separately
with the Commission. The omitted portions have been marked as follows: “***”.

ASSIGNMENT OF DISTRIBUTION AGREEMENT

        This ASSIGNMENT OF DISTRIBUTION AGREEMENT (this “Assignment”) is dated
and effective as of the Effective Time (as defined below) by and among Par
Pharmaceutical, Inc, a New Jersey corporation (“Par”), Bioglan Pharma, Inc., a
Delaware corporation (“Bioglan”), and Quintiles Ireland Limited, a company
incorporated in the Republic of Ireland (“Quintiles”).

        WHEREAS, Par and Bioglan are parties to the Distribution Agreement dated
as of December 27, 2000 (the “Agreement”):

        WHEREAS, Bioglan has agreed to sell certain assets to Quintiles or an
affiliate thereof (the “Asset Sale”), and in connection therewith Bioglan
desires to assign the Agreement to Quintiles; and

        WHEREAS, Quintiles desires to accept such assignment, Par desires to
consent to such assignment, and the parties hereto desire to effect certain
amendments to the Agreement, pursuant to the terms and conditions of this
Assignment;

        NOW, THEREFORE, in consideration of the foregoing premises, the
agreements made herein, and other good and valuable consideration, the receipt
and sufficiency of which is hereby acknowledged, the parties to this Assignment
hereby agree as follows:

        1. Effective Time. This Agreement shall be effective upon the closing of
the Asset Sale (the “Effective Time”). Quintiles shall promptly give Par written
notice of the occurrence of the Effective Time.

        2. Consent. Par, on behalf of itself, its successors and assigns, does
hereby irrevocably consent to (i) the assignment of the Agreement, and all
rights and obligations of Bioglan thereunder, from Bioglan to Quintiles, and
(ii) any subsequent assignment by Quintiles to any affiliate of Quintiles.

        3. Assignment. Bioglan does hereby assign, transfer, convey, grant and
deliver to Quintiles all of Bioglan’s right, title and interest in, to and under
the Agreement, and Quintiles shall succeed and be entitled to all of the past,
present and future rights, privileges, benefits and other interests of Bioglan
under the Agreement. Quintiles hereby assumes the obligations of’ Bioglan under
the Agreement arising after the Effective Time.

        4. Amendment. The parties to this Assignment hereby agree that the
Agreement is hereby amended as follows:

        A. All references in the Agreement to *** dosage amounts are hereby
deleted, including without limitation from Section 1.3. For the avoidance of
doubt, “Additional Tablets” shall refer only to 75 mg dosage amounts.

        B. The parties agree that Bioglan’s obligation to market and promote the
Products under Section 1.4 shall be limited to Products supplied by Par. In
addition, the fifth sentence of Section 1.4 of the Agreement is hereby amended
to read in its entirety as follows: “Where

 

   

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Bioglan’s net sales of the Tablets and the Additional Tablets (if applicable)
supplied by Par at the end of any calendar year following December 31, 2003 are
less than *** for such period, for reasons other than Par’s failure to supply
Product in accordance with the terms and conditions of this agreement, Par shall
have the right to manufacture and distribute a generic version of the Tablets or
the Additional Tablets, as the case may be, which is in the same dosage form,
has the same active ingredient, the same strength and is for the same indication
as the Tablets or the Additional Tablets.”

        C. Section 3.1 of the Agreement is hereby amended by adding the
following sentences at the end thereof: “In the event that Par fails to supply
Bioglan’s requirements of Products on a timely basis in accordance with the
terms and conditions set forth in this Agreement, Bioglan may, in addition to,
and without limitation of, any other rights Bioglan may have under this
agreement or pursuant to applicable law, upon ninety (90) days written notice to
Par, if Par has failed to cure such failure within such ninety (90) day period:
(i) purchase the ANDA from Par for a purchase price of ***and Par shall execute
and deliver such documents and instruments as Quintiles may reasonably request
in order to effectively transfer ownership of the ANDA, and (ii) manufacture
Products for itself and/or order and purchase Products from third parties. In
the event that Bioglan desires to manufacture Products for itself and/or to
order and purchase Products from third parties pursuant to the preceding
sentence, at Bioglan’s request, Par shall, without charge, use its best efforts
to facilitate the transfer of all applicable manufacturing technology and
know-how to Bioglan or such third parties. Without limiting the foregoing, Par
shall, without further consideration, take such actions (including without
limitation meeting with Bioglan or third parties, providing instructions, data
and documentation, and providing samples) and execute and deliver such documents
and instruments as Bioglan reasonably may request in order to effectively
accomplish the foregoing transfer of manufacturing technology and know-how so
that Bioglan or third parties are able to manufacture Products in a manner
substantially similar to Par. In addition, Par shall make known and available to
Bioglan all of its sources for materials, ingredients, components, supplies and
equipment used in connection with the manufacture of the Product, along with the
terms thereof and any agreements or other arrangements relating thereto, and in
the event Par fails to supply Bioglan’s requirements of Products on a timely
basis in accordance with the terms and conditions set forth in this Agreement,
at Bioglan’s request, Par shall use its best efforts to promptly assign any or
all of such agreements and arrangements to Bioglan and to facilitate
communications between Bioglan and the parties thereto.”

        D. The third sentence of Section 5.1(a) is hereby deleted in its
entirety and replaced by the following sentence: “The purchase price payable by
Bioglan for the Additional Tablets supplied to it by Par shall be *** per bottle
of 50 tablets (75 mg dosage) and *** per bottle of 100 tablets (75 mg dosage).”

        E. Section 5.1(a) of the Agreement is hereby amended by adding the
following sentences at the end thereof: “If, and to the extent, Par’s direct,
out-of-pocket, documented costs for raw materials has increased at the first
anniversary of the Effective Time over the amount of such costs as of the
Effective Time, upon reasonable prior written notice to Bioglan, Par may
increase the purchase prices of all affected Products by the amount of such
increase effective on such first anniversary. Par may similarly increase the
product prices at each subsequent

 

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anniversary of the Effective Time for the increase in Par’s direct,
out-of-pocket, documented costs for raw materials during the prior year.

        F. The third sentence of Section 5.1(c) is hereby deleted in its
entirety and replaced by the following sentence: “Thereafter, the price for
Product samples, including all samples of Additional Tablets, shall be equal to
Par’s direct, out-of-pocket, documented raw material costs for such samples.”

        G. The parties agree that the provisions of Sections 6.1 and 6.2 shall
apply only to Products supplied by Par.

        H. Section 11.1 is hereby amended to delete the notice information for
Bioglan and to insert in lieu thereof the notice information for Quintiles as
follows:

  Quintiles Ireland Limited
c/o Quintiles Transnational Corp.
4709 Creekstone Drive
Riverbirch Building, Suite 200
Durham, NC 27703
Attention: Thomas C. Perkins
Fax Number: 919-998-2090

        5. Payments. Within ten (10) days of the Effective Time, Quintiles shall
pay Par ***. In addition, Quintiles shall pay Par *** within thirty (30) days
after the earlier of December 1, 2002 or notice of approval from the FDA of
Additional Tablets (75 mg strength) that comply with the Agreement, including
without limitation the Products Manufacturing Requirements. Par shall use its
best efforts to develop the Additional Tablets for commercial sale as soon as
reasonably possible and to obtain all necessary regulatory approvals to market
the Additional Tablets in the Territory, including without limitation final FDA
approval for marketing the Additional Tablets. Par shall be responsible for all
costs associated the development of the Additional Tablets up through the date
on which they have been approved for such commercial sale.

        6. Miscellaneous. Capitalized terms not otherwise defined in this
Assignment shall have the meanings given to them in the Agreement. After the
Effective Time, references to “Bioglan” in the Agreement shall be deemed
references to “Quintiles.” Except as amended hereby, the Agreement shall remain
in full force and effect in accordance with its terms. Bioglan represents and
warrants to Quintiles that the Agreement is in full force and effect and that
Bioglan has complied with the terms of the Agreement. Par confirms and agrees
that the Agreement is in full force and effect and to its knowledge Bioglan has
complied with the terms of the Agreement.

 

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{Signature page to Assignment of Distribution Agreement}

        IN WITNESS WHEREOF, Par, Bioglan and Quintiles have duly executed this
Assignment.

  PAR PHARMACEUTICAL, INC.         By:  /s/ Kenneth I. Sawyer

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    Name:  Kenneth I. Sawyer

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    Title:  CEO

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      BIOGLAN PHARMA, INC.      By:  /s/ Robert J. Moccia

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    Name: Robert J. Moccia

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    Title: President

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      QUINTILES IRELAND LIMITED      By:  

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  Name:  

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  Title:  

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{Signature page to Assignment of Distribution Agreement}

        IN WITNESS WHEREOF, Par, Bioglan and Quintiles have duly executed this
Assignment.

 

  PAR PHARMACEUTICAL, INC.         By:  

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    Name:  

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    Title:  

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      BIOGLAN PHARMA, INC.      By:  

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    Name:

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    Title:

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      QUINTILES IRELAND LIMITED      By:  /s/ Ludo Reyndess

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  Name:  Ludo Reyndess

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  Title:  Director

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