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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