Document:

Exhibit 4.7

 

AMENDMENT

 

This AMENDMENT (hereinafter called the “AMENDMENT”) is made and entered into this 14th day of May, 2002 by and between Shionogi & Co.,Ltd., 1-8 Doshomachi 3-chome, Chuo-ku, Osaka, Japan (hereinafter called “SHIONOGI”) and AstraZeneca UK Limited, a U.K. corporation with its registered office at 15 Stanhope Gate, London, W1K 1LN, England (hereinafter referred to as “ASTRAZENECA”) concerning the LICENSE AGREEMENT dated April 20, 1998 by and between SHIONOGI and ASTRAZENECA (formerly Zeneca Limited) (hereinafter called the “AGREEMENT”).

 

WITNESSETH:

 

WHEREAS, IPR Pharmaceuticals (“IPR”), to which company ASTRAZENECA has sub-licensed its rights under the AGREEMENT, desired to have a partner in addition to ASTRAZENECA K.K., IPR’s AFFILIATE (as defined in the AGREEMENT) in Japan (“ASTRAZENECA KK”), to market the LICENSED PRODUCTS (as defined in the AGREEMENT) in Japan, and offered to SHIONOGI the first opportunity to be IPR’s marketing partner for the LICENSED PRODUCTS in Japan in accordance with Article 3.10 of the AGREEMENT;

 

WHEREAS, SHIONOGI showed its desire to co-market the LICENSED PRODUCTS in Japan with IPR;

WHEREAS, IPR is willing to select SHIONOGI as a co-marketing partner for the LICENSED PRODUCTS in Japan under the condition inter alia that certain terms and conditions of the AGREEMENT will be modified; and

WHEREAS, SHIONOGI and ASTRAZENECA are willing to modify the terms and conditions of the AGREEMENT as hereinafter set forth.

 

NOW THEREFORE, the PARTIES hereto hereby agree as follows:

 

Unless otherwise expressly provided herein, the capitalised terms wherever used in this AMENDMENT shall have the same meanings as ascribed to them in the AGREEMENT.

 

	
1.

	
Article 4.2 of the AGREEMENT shall be replaced by the following:

 

	 	
“4.2

	
In addition to the foregoing non-refundable payments, ASTRAZENECA shall pay SHIONOGI, on a country by country basis in the TERRITORY, running royalties equal to the following:

 

*** Certain information has been omitted pursuant to a request for confidential treatment and filed separately with the U.S. Securities and Exchange Commission.

  

-1-

  

 

 

	 	
(i)

	
 For the first two (2) years after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

 

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

 

	 	
(ii)

	
For the third (3rd) year after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

 

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

 

	 	
(iii)

	
For the fourth (4th) and fifth (5th) years after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

 

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

 

	 	
(iv)

	
For the sixth (6th) year after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

 

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

 

	 	
(v)

	
For the seventh (7th) year, and for any subsequent year, after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

 

[***] percent ([***]%) of the NET SALES of UCENSED PRODUCTS in such country

 

For the purposes of all of (i) to (v) above, the calculations for the COMBINATION PRODUCTS shall be made in accordance with the formula described in Article 4.3.

 

In the event that, in a country in the TERRITORY, as reported by an internationally recognised independent supplier of sales data acceptable to ASTRAZENECA and SHIONOGI, the volume share of non-ASTRAZENECA derived LICENSED PRODUCTS that is commercialised represents [***] percent ([***]%) or more of the total sales of all LICENSED PRODUCTS in that country (hereinafter referred to as the “RELEVANT SHARE”), then the royalty rate in respect of the LICENSED PRODUCTS in that country will be [***] to [***] percent ([***]%), or [***] percent ([***]%) in the first three (3) years, as the case may be.

 

*** Certain information has been omitted pursuant to a request for confidential treatment and filed separately with the U.S. Securities and Exchange Commission.

  

-2-

  

 

In the event that the RELEVANT SHARE exceeds [***] percent ([***]%), then ASTRAZENECA shall have the right to [***] in the given country.

The PARTIES acknowledge and agree that the foregoing will apply to situations in which, by reason of invalidity or absence of any PATENTS, ASTRAZENECA may be paying royalties based solely on its license to the KNOW-HOW and that the adjustments provided for in this Article have been established by the PARTIES as the means whereby in such a case the value of such license can be determined independently of the PATENTS during the remainder of the royalty period.”

 

	
2.

	
Effective as of the date of execution of this AMENDMENT, Article 5 of the AGREEMENT shall cease to be in effect.

 

Should the situation contemplated by Section 3, first paragraph, of this AMENDMENT occur, then, as of the date of such occurrence, Article 5 of the AGREEMENT shall be reinstated and enter into force again; provided, however, that the three (3) years period mentioned therein shall count from the date of such reinstatement.

 

	
3. 

	
Notwithstanding Section 1 of this AMENDMENT, in the event that ASTRAZENECA has not launched the LICENSED PRODUCTS in Japan by 30 April 2005,Article 4.2 of the AGREEMENT, as amended in accordance with this AMENDMENT, shall as of the date now mentioned, but applying from the date of execution of this AMENDMENT, be replaced by the following.

	 	
“4.2

	
In addition to the foregoing non-refundable payments, ASTRAZENECA shall pay SHIONOGI, on a country by country basis in the TERRITORY, the running royalties equal to the following:

	 	
(i)

	
For the first two (2) years after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

 

	 	
(ii)

	
For the third (3rd) year after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

 

*** Certain information has been omitted pursuant to a request for confidential treatment and filed separately with the U.S. Securities and Exchange Commission.

  

-3-

  

 

	 	
(iii)

	
For the fourth (4th) year after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

	 	
(iv)

	
For the fifth (5th) year after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

	 	
(v)

	
For the sixth (6th) year after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

[***] percent ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

	 	
(vi)

	
For the seventh (7th) year, and for any subsequent year, after the first launch of the LICENSED PRODUCTS in each country of the TERRITORY:

 

[***] ([***]%) of the NET SALES of LICENSED PRODUCTS in such country

For the purposes of all of (i) to (vi) above, the calculations for the COMBINATION PRODUCTS shall be made in accordance with the formula described in Article 4.3.

 

In the event that, in a country in the TERRITORY, as reported by an internationally recognised independent supplier of sales data acceptable to ASTRAZENECA and SHIONOGI, the volume share of non-ASTRAZENECA derived LICENSED PRODUCTS that is commercialised represents [***] percent ([***]%) or more of the total sales of all LICENSED PRODUCTS in that country (hereinafter referred to as the “RELEVANT SHARE”), then the royalty rate in respect of the LICENSED PRODUCTS in that country will be [***] to [***] percent ([***]%), or [***] percent ([***]%) in the first three (3) years, as the case may be.

 

In the event that the RELEVANT SHARE exceeds [***] percent ([***]%), then ASTRAZENECA shall have the right to [***] in the given country.

 

The PARTIES acknowledge and agree that the foregoing will apply to situations in which, by reason of invalidity or absence of any PATENTS, ASTRAZENECA may be paying royalties based solely on its license to the KNOW-HOW and that the adjustments provided for in this Article have been established by the PARTIES as the means whereby in such a case the value of such license can be determined independently of the PATENTS during the remainder of the royalty period.”

Should payments of royalties pursuant to Article 4.2 in its version according to Section 1 of this

 

*** Certain information has been omitted pursuant to a request for confidential treatment and filed separately with the U.S. Securities and Exchange Commission.

 

  

-4-

  

 

AMENDMENT have already commenced by the time this revised Article 4.2 takes effect, then ASTRAZENECA shall no later than ninety (90) days of 30 April 2005 pay to SHIONOGI the amount, calculated up until that date, being the difference, if any, between the aggregate royalty amount payable pursuant to Article 4.2 in its version under this Section 3 and the royalty amount payable pursuant to Article 4.2 in its version under Section 1 of this AMENDMENT.

	
4.

	
Subject to the amendments made hereunder, the terms and conditions of the AGREEMENT shall be kept unchanged and have full force.

 

IN WITNESS WHEREOF, the parties hereto have caused this AMENDMENT to be executed in duplicate by their duly authorised representatives on the date first above written.

	Shionogi & Co., Ltd.	 	AstraZeneca UK Limited	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	
/s/ M. Shiono

	  	 	/s/ Chris Petty	 
	
Name:  

	Mr Motozo Shiono	 	
Name: 

	Mr C R W Petty	 
	  	  	  	  	 	 
	
 

	
President

	  	  	Authorised Signatory	 

 

 

-5-Exhibit 4.8

 

Page 1 of 3

 

 

AMENDMENT NO. 2

 

This Amendment No. 2 (the “Amendment”) to the Licence Agreement dated 20 April 1998 by and between

 

	
(1)

	
Shionogi & Co., Ltd., a company incorporated in Japan, whose registered office is at 1-8 Doshomachi 3-chome, Chuo-ku, Osaka, Japan (“Shionogi”); and

 

	
(2)

	
ASTRAZENECA UK LIMITED (formerly Zeneca Limited), a company incorporated in England under no. 3674842 whose registered office is at 15 Stanhope Gate, London, W1K 1LN, England (“AstraZeneca”)

 

(the “Licence Agreement”) is made effective as of the 26th day of April 2005 (the “Amendment Effective Date”).

Recitals

WHEREAS, the Parties entered into an Amendment to the Licence Agreement on 14 May 2002 (the “Amendment No 1”) providing for inter alia certain changes to the royalty rates payable under the Licence Agreement and a removal of AstraZeneca’s obligation to offer Shionogi the right to participate in the development and/or marketing of a product in Japan; and

 

WHEREAS, under the Amendment No 1 the revised royalty rates provided for will become adjusted, and AstraZeneca’s obligation to offer Shionogi the participation in development and/or marketing of a product reinstated, should AstraZeneca not have launched the LICENSED PRDOUCTS in Japan by 30 April 2005; and

 

WHEREAS, the PARTIES do not wish that the extended duration of the process, which was recently completed, to have the LICENSED PRODUCTS registered with the health authorities in Japan results in the triggering of such adjusted royalty rates;

  

  

  

Page 2 of 3

 

NOW, THEREFORE, in consideration of the mutual covenants contained in this Amendment, and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the PARTIES, intending to be legally bound, agree as follows:

 

	
1

	
Definitions

 

Any capitalized term not separately defined in this Amendment shall have the meaning ascribed to it in the Licence Agreement.

 

	
2

	
Modifications

 

	
2.1 

	
Wherever reference is made to 30 April 2005 in Section 3 of the Amendment No 1 such reference shall be deemed to be made to 31 December 2005.

 

	
2.2 

	
Section 2 of the Amendment No 1 hereby cease to be in effect and Article 5 is thus hereby reinstated in the Licence Agreement, provided, however, that the three 3) years mentioned in Article 5 of the Licence Agreement, as reinstated, shall count from the Amendment Effective Date. In addition the following paragraph shall be added to such Article 5

 

“Upon a Change of Control of SHIONOGI ZENECA shall have the right to terminate SHIONOGI’s rights under this Article 5 with immediate effect by providing written notice to SHIONOGI. For the purpose of this Article 5 “Change of Control” means an event in which any other company, organisation or other entity acquires beneficial ownership of securities of  SHIONOGI representing more than fifty percent (50%) of the voting power of the then outstanding securities of SHIONOGI with respect to the election of directors of SHIONOGI.”

 

	
3

	
Amendment Effective Date

 

This Amendment shall become effective on the Amendment Effective Date.

 

  

  

  

Page 3 of 3

 

	
4

	
Entire Agreement

 

This Amendment, together with the Licence Agreement, constitutes the entire agreement between the PARTIES with respect to the subject matter of the Licence Agreement. The Licence Agreement together with this Amendment supersedes all prior agreements, whether written or oral, with respect to the subject matter of the Licence Agreement, as amended. Each PARTY confirms that it is not relying on any representations, warranties or covenants of the other PARTY except as specifically set out in the Licence Agreement as amended. Nothing in this Amendment is intended to limit or exclude any liability for fraud. The PARTIES hereby agree that subject to the modifications specifically stated in this Amendment, all terms and conditions of the Licence Agreement shall remain in full force and effect.

 

Execution

 

THIS AMENDMENT IS EXECUTED by the authorised representatives of the PARTIES as of the date first written above.

 

	SIGNED for and on behalf of 	 	SIGNED for and on behalf of	 
	AstraZeneca UK Limited	  	Shionogi & Co., Ltd.	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	  	  	  	  	 	 
	/s/ C R W Petty	  	/s/ Motozo Shiono	 
	Signature	 	Signature	 
	 	 	 	 	 	 
	
Name:  

	Mr C R W Petty	 	
Name: 

	Mr Motozo Shiono	 
	  	  	  	  	 	 
	
Title:

	
AUTHORISED SIGNATORY AB

	  	Title:	PRESIDENT

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