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TERMINATION AGREEMENT

Termination Agreement

TERMINATION AGREEMENT | Document Parties: Bayer Schering Pharma AG | EPIX Pharmaceuticals Inc | European Union | Lantheus Medical Imaging, Inc | Schering AG | TMC Pharma Services, Ltd You are currently viewing:
This Termination Agreement involves

Bayer Schering Pharma AG | EPIX Pharmaceuticals Inc | European Union | Lantheus Medical Imaging, Inc | Schering AG | TMC Pharma Services, Ltd

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Title: TERMINATION AGREEMENT
Governing Law: New York     Date: 4/7/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

TERMINATION AGREEMENT, Parties: bayer schering pharma ag , epix pharmaceuticals inc , european union , lantheus medical imaging  inc , schering ag , tmc pharma services  ltd
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Exhibit 10.2

TERMINATION AGREEMENT

 

 

 

between

 

Bayer Schering Pharma AG,
Müllerstraße 178,13353 Berlin, Germany

 

 

 

 

 

(hereinafter referred to as “BSP”)

 

 

 

 

 

 

and

 

EPIX Pharmaceuticals Inc.,
4 Maguire Rd
Lexington, MA 02421, USA

 

 

 

 

 

(hereinafter referred to as “EPIX”)

 

 

 

 

 

 

and

 

TMC Pharma Services, Ltd
Parfitts Farm, Chequers Lane
Eversley, Hants RG27 ONT, UK

 

 

 

 

 

(hereinafter referred to as “TMC”);

 

 

 

 

 

 

and

 

Lantheus Medical Imaging, Inc.
331 Treble Cove Road
North Billerica, MA

 

 

 

 

 

(hereinafter referred to as “Lantheus”)

 

 

 

 

 

 

 

 

(BSP, EPIX, TMC and Lantheus hereinafter collectively referred to as “the Parties” and each a “Party”)

Preamble:

WHEREAS, BSP (previously acting under the name Schering AG) and EPIX entered into a Strategic Collaboration Agreement dated June 9, 2000 as amended on December 22, 2000 (hereinafter referred to as “the Collaboration Agreement”) for the development and commercialization of a blood pool magnetic contrast agent designated as MS-325 (hereinafter referred to as “the Compound”).

WHEREAS, BSP obtained regulatory approval for and has been marketing a product containing the Compound (hereinafter referred to as “the Product”) under the trademark Vasovist ® in the European Union (hereinafter “EU”) and certain other countries outside the United States.

 


 

WHEREAS, BSP has terminated the Collaboration Agreement in accordance with Section 13.4.1 of the Collaboration Agreement with effect as of February 28, 2009.

WHEREAS, pursuant to the Collaboration Agreement, EPIX will be granted certain rights to continue commercialization of the Product.

WHEREAS, EPIX wishes certain marketing authorizations for the Product to be transferred to TMC and TMC Associates (as defined hereinafter).

WHEREAS, EPIX and Lantheus wish to enter into an Asset Purchase Agreement (and related agreements) pursuant to which EPIX is transferring its rights to the Product in the United States, Puerto Rico, Canada and Australia (the “Lantheus Territory”) to Lantheus (the “Lantheus Transaction”).

WHEREAS, the Parties wish to agree on certain details regarding the transfer of marketing authorizations and certain other issues related to the termination of the Collaboration Agreement and the Lantheus Transaction.

Now, therefore, the Parties agree as follows:

1.

 

DEFINITIONS

1.1

 

“Affiliate” means, with respect to a Party, any person, corporation, firm, joint venture or other entity which, directly or indirectly, through one or more intermediates, controls, is controlled by or is under common control with such Party. As used in this definition, “control” means possession of the power to direct or cause the direction of the management and policies of an entity, whether through the ownership of the outstanding voting securities or by contract or otherwise.

 

1.2

 

“Article 20 Procedure” means the referral under Article 20 of Council Regulation (EC) 726/2004 for centrally authorised gadolinium-containing contrast agents initiated on November 21, 2008.

 

1.3

 

“BSP Territory” means all countries of the world except the EPIX Territory. These countries include the EU (including Norway and Iceland), Switzerland, Canada, Australia, Bosnia-Herzegovina, Turkey, Korea, Ukraine and Serbia.

 

1.4

 

“EPIX Territory” means the United States.

 

1.5

 

“Marketing Authorization” means, with respect to any country or regulatory jurisdiction in the BSP Territory, the marketing authorization application or similar application, registration or certification necessary to import, market, sell and distribute the Product in such country or regulatory jurisdiction, including correspondence with regulatory authorities.

 

1.6

 

“TMC Associates” means third parties acting on behalf of TMC as designated by EPIX in writing on a country-by-country basis.

 

17

 

“Trademark” means BSP’s trademark Vasovist ® .

2


 

1.8

 

“Variations shall have the meaning as set forth in Section 5.1.

2.

 

TERMINATION OF COMMERCIALIZATION BY BSP

 

2.1

 

Subject to Sections 2.2, as of March 1, 2009, BSP will no longer promote, sell, market or distribute the Product in the BSP Territory.

 

2.2

 

Notwithstanding Section 2.1, until May 31, 2009, BSP shall have the right to manufacture packaging materials for, package and supply Product to fulfill any orders for Product in the BSP Territory accepted prior to March 1, 2009. If, however, the transfer of the Marketing Authorization in any country is completed prior to May 31, 2009, BSP will cease to distribute Product in those countries. In addition, any contracts entered by BSP prior to March 1, 2009 relating to investigator initiated studies involving the Product will continue to be fulfilled by BSP after February 28, 2009, and shall not be transferred to EPIX. BSP will not enter into any new contracts relating to investigator initiated studies (or other studies) involving the Product after March 1, 2009.

 

2.3

 

With regard to the EPIX Territory, BSP and EPIX agree that even prior to March 1, 2009, BSP is and was not obliged to undertake any further pre-launch or launch activities relating to the Product after re-submission of the NDA in July 2008. The Parties agree further that should EPIX enter into an agreement relating to the Product with regard to the EPIX Territory, subject to Section 10 all rights and obligations of BSP with regard to commercialization of the Product in the EPIX Territory shall cease as of execution of such agreement.

3.

 

TRANSFER OF MARKETING AUTHORIZATIONS

 

3.1

 

For purposes of this Termination Agreement (hereinafter “Agreement”), the transfer of a Marketing Authorization in a specific country is not complete until all applicable regulatory requirements relating to the transfer have been met and TMC, Lantheus or a designated third party is approved as the Marketing Authorization Holder for the Product by the appropriate regulatory authority in the country.

 

3.2

 

Immediately after execution of this Agreement, the Parties shall cooperate with the purpose of completing as quickly as possible a transfer of the Marketing Authorization for countries in the EU (EMEA centralized MAA) to TMC. Should a transfer to TMC (or any other third party designated by EPIX) not have been completed by November 30, 2009, BSP shall be entitled to withdraw the Marketing Authorization for the EU. However, if due to the Article 20 Procedure the transfer of the Marketing Authorization is delayed in a way so that the transfer is not completed by November 30, 2009, BSP shall remain Marketing Authorization Holder in the EU an additional month after November 30, 2009 for each month of Delay. For the purpose of this Section 3.2, Delay means any period after execution of this Termination Agreement where, due to the Article 20 Procedure, a notification for the transfer of the Marketing Authorization in the EU can not be filed or is not processed by the EMEA.

 

3.3

 

BSP has already initiated, upon agreement with EPIX, the transfer of the Marketing Authorization for Switzerland to a TMC Associate. Immediately after execution of this Agreement and receipt of the amount of USD 10,500,000 in

3


 

 

 

accordance with Section 10.2, the Parties shall cooperate and use commercially reasonable efforts with the purpose of completing as quickly as possible a transfer of the Marketing Authorization for Canada and Australia to Lantheus as set forth herein. Should a transfer of the Marketing Authorization to Lantheus not have been completed by November 30, 2009 for the respective countries, BSP shall be entitled to withdraw the Marketing Authorization for the respective countries.

 

3.4

 

With regard to Bosnia-Herzegovina, Turkey, Korea, Ukraine and Serbia, BSP shall remain the holder of the Marketing Authorization and without any obligation to market the Product, until EPIX has designated in writing a third party to whom the Marketing Authorization shall be transferred. Should a transfer of the Marketing Authorization to a designated third party not have been completed by November 30, 2009, BSP shall be entitled to withdraw the Marketing Authorization for the respective countries. However, if due to the pending approval of the Variations the transfer of the Marketing Authorization is delayed in a way so that the transfer is not completed by November 30, 2009, BSP shall remain Marketing Authorization Holder in the respective country an additional month after November 30, 2009 for each month of Delay. For the purpose of this Section 3.4, Delay means any period after receipt of EPIX’ notice to whom the Marketing Authorization shall be transferred where, due to the pending approval of the Variations, a notification for the transfer of the Marketing Authorization can not be filed or is not processed by the regulatory authorities.

 

3.5

 

BSP has in agreement with EPIX withdrawn pending applications for Brazil, Thailand, Malaysia, Nicaragua, Russia, Guatemala, Indonesia and China (CTA). Furthermore, BSP shall withdraw pending applications for South Africa, Sri Lanka and El Salvador. If withdrawal is not possible due to the advanced registration process, the Marketing Authorization should be handled as described in Section 3.4 of this Agreement and the pharmacovigilance obligations should be handled as described in the Pharmacovigilance Agreement Regarding Vasovist ® signed by BSP, EPIX, and TMC on March 2, 2009 (hereinafter “Pharmacovigilance Agreement”).

 

3.6

 

EPIX agrees to reimburse BSP for all costs incurred by BSP or its Affiliates for any activities regarding the Product that occur after February 28, 2009 and that are requested by government regulatory authorities in the BSP Territory while BSP remains the holder of the Marketing Authorization (or becomes the holder pursuant to Section 2.5 of this Agreement) in the respective country of the BSP Territory, provided that such activities do not arise from any gross negligence or wilful misconduct of BSP or any of BSP’s Affiliates, contractors or agents or a material breach by BSP of any written agreement between BSP and EPIX.

4.

 

ARTICLE 20 PROCEDURE

 

4.1

 

The Parties shall cooperate with each other with regard to activities required by the Article 20 Procedure. BSP will remain the sole contact partner for EMEA until the transfer of the Marketing Authorization for the EU has been completed. All costs associated with the Article 20 Procedure will be paid by BSP until the transfer of the Marketing Authorization is completed. Once the transfer of the Marketing Authorization is complete, TMC/EPIX will become the sole contact partner for all correspondence with the EMEA and take over all responsibilities as the holder of the Marketing Authorization.

4


 

4.2

 

BSP has prepared the initial response to the Article 20 Procedure, including the requested risk management plan, and, until the transfer of the Marketing Authorization for the EU has been completed, it will prepare any future answers to such questions which are retrospective. Regarding future questions and requests, TMC will prepare and send to BSP on behalf of EPIX any documents relating to future activities concerning the Product. Each Party will give the other Party the opportunity to review and comment on the documents prepared by it before submission to EMEA and will not unreasonably ignore any comments received from the other Party, provided, however, that until completion of the transfer of the Marketing Authorization for the EU, BSP will have the final say. BSP shall, however, have no responsibility for the accuracy or completeness of responses prepared by it and will not be in any way liable to EPIX TMC or any third party for any economic consequences, damages or losses resulting from the outcome of the Article 20 Procedure. After completion of the transfer of the Marketing Authorization in the EU (implementation date as agreed with EMEA) the entire responsibility for the Article 20 response, including the actions resulting from the Article 20 Procedure will be assumed by TMC/EPIX.

 

4.3

 

Any preclinical data not related to the Product and made available to EPIX and/or TMC within the Article 20 Procedure may not be used by EPIX or TMC for any other purpose.

5.

 

VARIATIONS

 

5.1

 

Promptly after execution of this Agreement and receipt of the amount of USD 10,500,000 in accordance with Section 10.2, BSP shall submit to EPIX and Lantheus all documents as a complete CTD application, necessary for the filing of type II variations no. 2781 and 2784 as specified in Appendices 1 and 2 (hereinafter “the Variations”). EPIX will contract with TMC or TMC Associates to file such Variations in the EU and Switzerland at BSP’s cost as soon as possible after completion of the transfer of the Marketing Authorization. As the holder of such Marketing Authorizations TMC or TMC Associates will take over all responsibilities in connection with the filing of such Variations, provided that BSP will reimburse TMC for the filing fees associated with these Variations within thirty (30) business days of written confirmation of completion in each country and receipt of a respective invoice. Lantheus will file such Variations in Canada and Australia at BSP’s cost as soon as possible after completion of the transfer of the Marketing Authorization. As the holder of such Marketing Authorizations, Lantheus will take over all responsibilities in connection with the filing of such Variations, provided that BSP will reimburse Lantheus for the filing fees associated with these Variations within thirty (30) business days of written confirmation of completion in each country and receipt of a respective invoice.

 

5.2

 

If EMEA rejects the transfer of the Marketing Authorization in the EU during the ongoing Article 20 Procedure, BSP shall file the above mentioned type II Variations in the countries specified in Section 5.1 immediately after receipt of such clarification from EMEA. In addition, BSP will file such Variations in any other countries of the BSP Territory, except Switzerland, Canada and Australia. Once the transfer of the Marketing Authorization is completed in a specific country, the transferee


 
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