SIXTH AMENDMENT AGREEMENT

EX-10.3 3 dex103.htm SIXTH AMENDMENT AGREEMENT Sixth Amendment Agreement

Exhibit 10.3

SIXTH AMENDMENT AGREEMENT

This Sixth Amendment Agreement, effective as of August 18, 2006 (the “Effective Date”), is entered into by and between the Institute of Organic Chemistry and Biochemistry of the Academy of Sciences of the Czech Republic, having offices at Flemingovo nam. 2, 166 10 Praha 6, Czech Republic (“IOCB”); and the K. U. Leuven Research and Development (representing the REGA Institute for Medical Research, Leuven), having offices at Groot Begijnhof 59, B-3000 Leuven, Belgium (“REGA”) (IOCB and REGA hereinafter collectively referred to as “IOCB/REGA”) on one side and Gilead Sciences, Inc., a Delaware, USA corporation, having offices at 333 Lakeside Drive, Foster City, California 94404, U.S.A. (“Gilead”), on the other side. In this Sixth Amendment Agreement IOCB, REGA and GILEAD are sometimes referred to individually as a “Party” and collectively as the “Parties”.

WITNESSETH:

WHEREAS, the Parties have entered into the License Agreement dated effective November 15, 1991 (the “1991 License Agreement”), relating to N-phosphonylmethoxyalkyl purines and pyrimidines and analogues including HPMPC as well as acyclic nucleotide analogues and other compounds; the License Agreement dated effective October 15, 1992 (the “1992 License Agreement”), relating to N-(3-fluoro-2-phosphonomethoxypropyl) derivatives of heterocyclic bases; and the License Agreement dated effective December 1, 1992 (the “1992 PMPA License Agreement”), relating to (R) PMPA and (R) PMPDAP and other compounds. The 1991 License Agreement, the 1992 License Agreement, and the 1992 PMPA License Agreement are referred to collectively as the “License Agreements”; and

WHEREAS, the License Agreements were first amended by the Amendment Agreement dated effective October 25, 1993; and further amended by Annex 1 on April 1, 1997, by Annex 2 on March 20, 2002, and by the Letter Agreement dated April 8, 2002 (the “First Amendment Agreement”); and

WHEREAS, the 1991 License Agreement was subsequently amended by the Second Amendment Agreement dated effective January 1, 1996 (the “Second Amendment Agreement”); and further amended by the Third Amendment Agreement dated effective April 23, 2002 (the “Third Amendment Agreement”); and the License Agreements were further amended by the Fourth Amendment Agreement dated effective August 1, 2004 (the “Fourth Amendment Agreement”), and by the Fifth Amendment Agreement dated effective January 1, 2006 (the “Fifth Amendment Agreement”);

WHEREAS, the 1991 License Agreement and the 1992 PMPA License Agreement were further amended by the Letter Agreement dated effective December 26, 2000, as amended on December 27, 2000 (the “December 2000 Letter Agreement”); and


WHEREAS, the Parties now desire to amend the License Agreements, as previously amended, in order to further clarify certain payment provisions related thereto;

NOW, THEREFORE, the Parties agree as follows:

 

  1. All capitalized terms used in this Sixth Amendment Agreement but not defined herein shall have the meaning assigned in the License Agreements, as amended.

 

  2. The royalty obligations set forth in Sections IV A(b), IV A(c), IV B and IV C of the 1992 PMPA License Agreement, as amended in Section 4 of the December 2000 Letter Agreement, and as further amended in Sections 1.3(a), (b) and (c) of the Fourth Amendment Agreement, shall only apply to sales by Gilead, its AFFILIATES and sublicensees of LICENSED COMPOUND or LICENSED PRODUCT, including any COMBINATION PRODUCT, in each case containing Tenofovir (as defined in the December 2000 Letter Agreement) (each hereinafter a “PRODUCT”), in the countries set forth in Exhibit A (the “HIGH-INCOME TERRITORY”), and shall be payable for the term set forth therein.

 

  3. With respect to sales by Gilead, its AFFILIATES and sublicensees of PRODUCT in all countries of the world other than those in the HIGH-INCOME TERRITORY, the royalty obligations set forth in Sections IV A(b), IV A(c), IV B and IV C of the 1992 PMPA License Agreement, Section 4 of the December 2000 Letter Agreement, and Section 1.3 of the Fourth Amendment Agreement, are hereby amended as follows:

 

  a. Except as set forth in Section 3(c) below, with respect to sales of PRODUCT by Gilead, its AFFILIATES and sublicensees sold for end use in the countries set forth in Exhibit B (the “UPPER MIDDLE INCOME AND LOWER-MIDDLE INCOME TERRITORY”), Gilead will pay to IOCB/REGA a royalty of three percent (3%) of the gross amount received by Gilead from any third party in consideration for the sale of such PRODUCT. For purposes of this Section 3(a), “gross amount received” shall include, but shall not be limited to, (i) Gilead’s NET SALES for direct sales of PRODUCT by Gilead, or (ii) the total amount received by Gilead, in the form of a royalty, transfer price or other means of payment, for sales of PRODUCT by Gilead’s distributors and sublicensees, as appropriate.

 

  b. With respect to sales of PRODUCT in final finished form for administration to end users (“FINISHED PRODUCT”) manufactured by Indian generic companies under a license from Gilead (each an “Indian Company”) and sold in India and/or the countries set forth in Exhibit C (the “ACCESS COUNTRIES”), Gilead will pay to IOCB/REGA a royalty of twenty percent (20%) of the gross amount received by Gilead from any such Indian Company in consideration for the sale of such FINISHED PRODUCT.

 

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  c. With respect to sales of PRODUCT in the ACCESS COUNTRIES by Gilead, Merck, Sharp & Dohme, Aspen Pharmacare, or their respective AFFILIATES, or any other entity with whom Gilead enters into similar no-profit or minimum-profit arrangements in the ACCESS COUNTRIES, no royalties shall be payable to IOCB/REGA. Any future arrangements in the ACCESS COUNTRIES, other than such no-profit or minimum-profit arrangements, which result in a royalty obligation from Gilead to IOCB/REGA will be discussed on a case-by-case basis, and any such royalty obligation will be determined upon mutual agreement of the Parties.

 

  d. The payments by Gilead as required under Section 3(a) and (b) of this Sixth Amendment Agreement shall be payable to IOCB/REGA commencing on the Effective Date of this Sixth Amendment Agreement and shall continue until the expiration of the last to expire LICENSED PATENT a VALID CLAIM of which would be infringed but for the License Agreements, as amended.

 

  e. Gilead shall provide to IOCB/REGA copies of all sublicenses or other agreements (i) under which Gilead receives payment as described in Section 3(a) or (b) of this Sixth Amendment Agreement, or (ii) which fall within the scope of agreements described in Section 3(c) of this Sixth Amendment Agreement.

 

  4. The territories set forth in each of the exhibits attached hereto may be modified from time to time as appropriate. Countries that are not listed on the exhibits attached hereto as of the Effective Date may be added from time to time by Gilead, provided, however, that Gilead will not assign any such added country to one of the territories defined in the attached exhibits using a method other than through the “gross national income per capita” formula that Gilead used to create the defined territories as of the Effective Date. Gilead may also reassign a country from one defined territory to another if such a reassignment is justified using such “gross national income per capita” formula. Any deviation from such formula, or other circumstance that results in a different allocation of countries into the defined territories, will be subject to mutual written agreement between the Parties.

 

  5. Gilead agrees that at all times it shall carry out its obligations under this Sixth Amendment Agreement in good faith and that it shall not enter into any arrangement intended to allow Gilead to evade or reduce its obligations to IOCB/REGA set forth in this Sixth Amendment Agreement.

 

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  6. Except as expressly provided in this Sixth Amendment Agreement, the License Agreements, as amended, shall remain in full force and effect according to their terms.

IN WITNESS WHEREOF, the parties hereto have caused this Sixth Amendment Agreement to be executed by their respective duly authorized representatives as of the Effective Date.

 

INSTITUTE OF ORGANIC CHEMISTRY

AND BIOCHEMISTRY AV CR

   

REGA INSTITUTE

FOR MEDICAL RESEARCH

By:  

 

    By:  

 

  Prof. Zdenek Havlas, Director       Prof. Erik De Clercq, President
Date:  

 

    Date:  

 

K.U. LEUVEN RESEARCH AND DEVELOPMENT     GILEAD SCIENCES, INC.
By:  

 

    By:  

 

  Prof. Koenraad Debackere, Director      

John F. Milligan, Ph.D.

Executive Vice President & CFO

Date:  

 

    Date:  

 

By:  

 

     
  Paul VAN DUN, Director      
Date:  

 

     

 

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Exhibit A

The HIGH-INCOME TERRITORY

 

1.   Australia    27.   Latvia
2.   Austria    28.   Lithuania
3.   Bahrain    29.   Luxembourg
4.   Belgium    30.   Macedonia, TFYR
5.   Bosnia & Herzegovina    31.   Malta
6.   Brunei Darussalam    32.   Netherlands
7.   Bulgaria    33.   New Zealand
8.   Canada    34.   Norway
9.   Croatia    35.   Poland
10.   Cyprus    36.   Portugal
11.   Czech Republic    37.   Qatar
12.   Denmark    38.   Romania
13.   Estonia    39.   Saudi Arabia
14.   Finland    40.   Singapore
15.   France    41.   Slovakia
16.   Germany    42.   Slovenia
17.   Greece    43.   Spain
18.   Hong Kong    44.   Sweden
19.   Hungary    45.   Switzerland
20.   Iceland    46.   Turkey
21.   Ireland    47.   United Arab Emirates
22.   Israel    48.   United Kingdom
23.   Italy    49.   United States
24.   Japan     
25.   Korea, Republic of     
26.   Kuwait     

 

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Exhibit B

The UPPER MIDDLE-INCOME TERRITORY

 

1. Argentina
2. Brazil
3. Chile
4. Colombia
5. Costa Rica
6. Lebanon
7. Malaysia
8. Mexico
9. Oman
10. Panama
11. Uruguay
12. Venezuela

The LOWER MIDDLE-INCOME TERRITORY

 

1. Albania
2. Algeria
3. Armenia
4. Azerbaijan
5. Belarus
6. China
7. Ecuador
8. Egypt
9. El Salvador
10. Fiji
11. Georgia
12. Iran, Islamic Rep. of
13. Jordan
14. Kazakhstan
15. Libya
16. Morocco
17. Paraguay
18. Peru
19. Philippines
20. Sri Lanka
21. Tonga
22. Tunisia
23. Turkmenistan

 

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Exhibit C

The ACCESS COUNTRIES

 

1.   Afghanistan    34.   Guatemala    67.   Saint Lucia
2.   Angola    35.   Guinea    68.   Saint Vincent & the Grenadines
3.   Antigua and Barbuda    36.   Guinea-Bissau    69.   Samoa
4.   Bahamas    37.   Guyana    70.   Sao Tome and Principe
5.   Bangladesh    38.   Haiti    71.   Senegal
6.   Barbados    39.   Honduras    72.   Seychelles
7.   Belize    40.   Indonesia    73.   Sierra Leone
8.   Benin    41.   Jamaica    74.   Solomon Islands
9.   Bhutan    42.   Kenya    75.   Somalia
10.   Bolivia    43.   Kiribati    76.   South Africa
11.   Botswana    44.   Kyrgyzstan    77.   Sudan
12.   Burkina Faso    45.   Lao, People’s Dem. Rep.    78.   Surinam
13.   Burundi    46.   Lesotho    79.   Swaziland
14.   Cambodia    47.   Liberia    80.   Syria
15.   Cameroon    48.   Madagascar    81.   Tajikistan
16.   Cape Verde    49.   Malawi    82.   Tanzania, U. Rep. of
17.   Central African Republic    50.   Maldives    83.   Thailand
18.   Chad    51.   Mali    84.   Timor-Leste
19.   Comoros    52.   Mauritania    85.   Togo
20.   Congo    53.   Mauritius    86.   Trinidad and Tobago
21.   Congo, Dem. Rep. of the    54.   Moldova, Rep. of    87.   Tuvalu
22.   Cote d’ivoire    55.   Mongolia    88.   Uganda
23.   Cuba    56.   Mozambique    89.   Uzbekistan
24.   Djibouti    57.   Myanmar    90.   Vanuatu
25.   Dominica    58.   Namibia    91.   Vietnam
26.   Dominican Republic    59.   Nepal    92.   Yemen
27.   Equatorial Guinea    60.   Nicaragua    93.   Zambia
28.   Eritrea    61.   Niger    94.   Zimbabwe
29.   Ethiopia    62.   Nigeria     
30.   Gabon    63.   Pakistan     
31.   Gambia    64.   Papua NewGuinea     
32.   Ghana    65.   Rwanda     
33.   Grenada    66.   Saint Kitts and Nevis     

 

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